Synacthen Ampoules 250mcg/Ml
 

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Synacthen Ampoules 250mcg


1. Name Of The Medicinal Product

Synacthen® Ampoules 250mcg

2. Qualitative And Quantitative Composition

Tetracosactide acetate PhEur 250micrograms per ampoule.

3. Pharmaceutical Form

A clear colourless sterile solution in a clear glass ampoule.

4. Clinical Particulars 4.1 Therapeutic Indications

Diagnostic test for the investigation of adrenocortical insufficiency.

4.2 Posology And Method Of Administration

Adults: This preparation of Synacthen is intended for administration for diagnostic purposes only as a single intramuscular or intravenous dose; it is not to be used for repeated therapeutic administration.

The 30-minute Synacthen diagnostic test: This test is based on measurement of the plasma cortisol concentration immediately before and exactly 30 minutes after an intramuscular or intravenous injection of 250micrograms (1ml) Synacthen. Adrenocortical function can be regarded as normal if the post-injection rise in plasma cortisol concentration amounts to at least 200nmol/litre (70micrograms/litre).

Where the 30-minute test has yielded inconclusive results, or where it is desired to determine the functional reserve of the adrenal cortex, a 5-hour test can be performed with Synacthen Depot (see separate Summary of Product Characteristics). Furthermore, a 3-day test with Synacthen Depot may be used to differentiate between primary and secondary adrenocortical insufficiency.

Children: An intravenous dose of 250micrograms/1.73m? body surface area has been suggested. Thus for children aged 5 to 7 years, approximately half the adult dose will be adequate. For more accurate dosing of other ages, standard body surface area tables should be consulted.

Elderly: There is no evidence to suggest that dosage should be different in the elderly.

4.3 Contraindications

History of hypersensitivity to ACTH, Synacthen or Synacthen Depot. Synacthen is contra-indicated in patients with allergic disorders (e.g. asthma).

4.4 Special Warnings And Precautions For Use

Before using Synacthen, the doctor should make every effort to find out whether the patient is suffering from, or has a history of, allergic disorders (see Section 4.3 “Contra-indications”). In particular, he should enquire whether the patient has previously experienced adverse reactions to ACTH, Synacthen or other drugs.

Synacthen should only be administered under the supervision of appropriate senior hospital medical staff (e.g. consultants).

If local or systemic hypersensitivity reactions occur after the injection (for example, marked redness and pain at the injection site, urticaria, pruritus, flushing, faintness or dyspnoea), Synacthen or other ACTH preparations should be avoided in the future. Hypersensitivity reactions tend to occur within 30 minutes of an injection. The patient should therefore be kept under observation during this time.

Preparation should be made in advance to combat any anaphylactic reaction that may occur after an injection of Synacthen. In the event of a serious anaphylactic reaction occurring, the following measures must be taken immediately: administer adrenaline (0.4 to 1ml of a 0.1% solution intramuscularly or 0.1 to 0.2ml of a 0.1% solution in 10ml physiological saline slowly intravenously) as well as a large intravenous dose of a corticosteroid (for example 100mg to 500mg hydrocortisone, three or four times in 24 hours), repeating the dose if necessary.

The hydrocortisone product information prepared by the manufacturer should also be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

The Synacthen test should not be utilised during pregnancy and lactation unless there are compelling reasons for doing so.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness.

4.8 Undesirable Effects

Hypersensitivity reactions:

Synacthen may provoke hypersensitivity reactions. In patients suffering from, or susceptible to, allergic disorders (especially asthma) this may take the form of anaphylactic shock (see Section 4.3 “Contra-indications”).

Hypersensitivity may be manifested as skin reactions at the injection site, dizziness, nausea, vomiting, urticaria, pruritus, flushing, malaise, dyspnoea, angioneurotic oedema and Quinke's oedema.

Other side effects are unlikely to be observed with short-term use of Synacthen as a diagnostic tool. Should information be required on the side effects reported with therapeutic use of tetracosactide acetate, see Synacthen Depot Summary of Product Characteristics.

4.9 Overdose

Overdosage is unlikely to be a problem when the product is used as a single dose for diagnostic purposes.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Tetracosactide acetate consists of the first 24 amino acids occurring in the natural corticotropic hormone (ACTH) sequence and displays the same physiological properties as ACTH. In the adrenal cortex, it stimulates the biosynthesis of glucocorticoids, mineralocorticoids, and, to a lesser extent androgens.

The site of action of ACTH is the plasma membrane of the adrenocortical cells, where it binds to a specific receptor. The hormone-receptor complex activates adenylate cyclase, stimulating the production of cyclic AMP (adenosine monophosphate) and so promoting the synthesis of pregnenolone from cholesterol. From pregnenolone the various corticosteroids are produced via different enzymatic pathways.

5.2 Pharmacokinetic Properties

Following an intravenous injection, elimination of tetracosactide acetate from the plasma consists of 3 phases. The half-lives of these phases are approximately 7 minutes (0 to 1 hour), 37 minutes (1 to 2 hours) and 3 hours thereafter.

Tetracosactide acetate has an apparent volume of distribution of approximately 0.4L/kg.

In the serum, tetracosactide acetate is broken down by serum endopeptidases into inactive oligopeptides and then by aminopeptidases into free amino acids. The rapid elimination from plasma is probably not attributable to this relatively slow cleavage process, but rather to the rapid concentration of the active substance in the adrenal glands and kidneys.

Following an iv dose of 131I-labelled tetracosactide acetate, 95 to 100% of the radioactivity is excreted in the urine within 24 hours.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber, which are additional to those already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Acetic acid, sodium acetate, sodium chloride and water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Synacthen should be protected from light and stored in a refrigerator (2 - 8°C).

6.5 Nature And Contents Of Container

The ampoules are colourless glass PhEur type I. Five ampoules are packed in a cardboard box.

6.6 Special Precautions For Disposal And Other Handling

Shake well before use.

Administrative Data 7. Marketing Authorisation Holder

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

8. Marketing Authorisation Number(S)

PL 16853/0017

9. Date Of First Authorisation/Renewal Of The Authorisation

25 June 1998

10. Date Of Revision Of The Text

February 2005

11. Legal Status

POM

Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks of Alliance Pharmaceuticals Ltd.


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Hemabate Sterile Solution


PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

HEMABATE STERILE SOLUTION FOR INJECTION

Carboprost tromethamine 250mcg/ml

In this leaflet: 1. What Hemabate Sterile Solution is and what it is used for 2. Before you are given Hemabate Sterile Solution 3. How you are given Hemabate Sterile Solution 4. Possible side effects 5. Storing Hemabate Sterile Solution 6. Further information What Hemabate Sterile Solution is and what it is used for Hemabate is a sterile solution for injection. It is available in ampoules and contains 250mcg of the active ingredient, carboprost, per ml of solution. Hemabate is used to stop excessive bleeding in women who have just given birth, when bleeding is due to the womb failing to return to its normal size. Hemabate belongs to a group of medicines called prostaglandins. Prostaglandins are produced naturally in your body and are very important for a variety of activities, including childbirth. After childbirth they make the womb contract and to help it stay contracted, which stops heavy bleeding from the womb. Hemabate given after childbirth increases the contraction of your womb which helps to control bleeding after delivery. Before you are given Hemabate Sterile Solution Do not take Hemabate:

Hemabate is not suitable for all women. Your doctor may decide to give you a different medicine if any of these apply to you.

You should not be given Hemabate if you:

have ever had an allergic reaction to Hemabate or to any of the other ingredients of the medicine, in particular benzyl alcohol which can cause problems in some people – see Sections 4 and 6 of this leaflet for more details. currently have an infection of your womb, ovaries or fallopian tubes (this may be causing pain in your pelvis or vaginal discharge). Take special care with Hemabate:

Tell your doctor if you currently have, or have had in the past any of the following, as Hemabate will have to be used more carefully;

glaucoma (raised pressure in your eyes) high or low blood pressure (including high blood pressure in pregnancy) heart disease or anaemia (low blood count) lung disease, including asthma kidney or liver disease (including jaundice) diabetes or epilepsy a caesarean section or any other operation on your womb Taking other medicines:

Treatments that strengthen contraction of the womb, including oxytocin and ergometrine, can be affected by Hemabate. Medical staff will watch over you very carefully if you have had these treatments as well as Hemabate.

Tell your midwife or doctor if you are taking any other medicines.

Pregnancy and Breastfeeding:

Hemabate will only be given shortly after you have delivered your baby and not while you are still pregnant.

It is not known if carboprost is excreted in human breast milk. As your own body produces prostaglandins during childbirth, Hemabate is not expected to cause any harm to your baby.

Driving and using machinery:

It is unlikely that you will be well enough to drive or operate machinery soon after receiving Hemabate. Make sure you are fully recovered before driving or doing any activity where you need to concentrate.

Important information about some of the ingredients of Hemabate

Hemabate contains less than 1 mmol sodium (23mg) per dose and is essentially ‘sodium free.’

Hemabate also contains benzyl alcohol which may cause allergic reactions.

How you are given Hemabate Sterile Solution

This product should be used only in hospitals and clinics with specialised units for pregnancy and childbirth. Medical staff should be available in the hospital at all times. Hemabate may be given by a doctor or a midwife.

The staff will make sure that this medicine is used in the right way and at the right time. You should never be given Hemabate while you are pregnant, only after the birth. It must never be given by injection into a vein.

Hemabate is given by injection deep into a muscle. The first dose is usually 1 ml of solution (250 micrograms of carboprost). Your doctor may give you more doses of 1 ml if you need them. You should not have doses more often than once every 15 minutes. Usually you would have them less often, about once in one-and-a-half hours. You should not be given more than 8 doses (2 mg of carboprost) altogether What if I am given too much Hemabate?

If you get very bad sickness and diarrhoea, your doctor may delay the next injection of Hemabate, or may not give you any more doses. Your doctor will treat the symptoms that the Hemabate has caused

What if I continue to bleed?

If you continue to bleed heavily after being given Hemabate you may be given other medicines to help control the bleeding. Your doctor or midwife will be watching you closely to help them decide whether Hemabate is working for you.

Possible Side Effects

All medicines can cause side effects.

The following side effects occur occasionally after Hemabate treatment and can be serious, so it is important to bring these to the attention of medical staff straight away:

Effects on your respiratory system and immune system: Hemabate can very occasionally cause serious breathing difficulties as well as asthma and wheezing. If you have any difficulty breathing after receiving Hemabate tell your doctor or midwife immediately. The benzyl alcohol in Hemabate solution can cause an allergic reaction in some people. If you suffer from wheezing together with any itching or swelling of the face or tongue tell your doctor or midwife immediately. Other side effects seen with Hemabate include: Effects on your heart and circulation: Hemabate may temporarily raise blood pressure and sometimes this can be dangerous if it gets very high. It can also suddenly lower blood pressure making you faint. Your doctor or midwife will be monitoring your blood pressure closely to look for signs of this. Some people treated with carboprost may develop low oxygen levels in their blood. It is still unclear whether this is caused by treatment with carboprost. If you develop low oxygen levels, it might make you feel dizzy. Your doctor can give you extra oxygen if this happens to you. Effects on your stomach and intestines: The most common side effects with Hemabate are nausea (feeling sick), vomiting and diarrhoea. If these side effects are very bad, your doctor may give you other medicines to stop you being sick and to reduce the diarrhoea. They may also reduce or delay the next dose (also see ‘How you are given Hemabate’, above). Effects on your metabolism Hemabate can cause you to experience changes in body temperature. You may feel hot, flushed and sweaty, or chilled and shivery. These effects usually wear off quickly after treatment. Effects on skin: Hemabate can sometimes cause pain and redness around where you had your injection.

Most effects are mild and short-lived and will wear off quickly after treatment. If you feel very unwell or have any other unusual effects not listed above, tell your doctor at once.

Storing Hemabate Sterile Solution

Hemabate should not be used after the expiry date printed on the box and on the ampoule. Your pharmacist will check this before the injection is given.

Ampoules should be stored in a refrigerator between 2 – 8 °C. Your pharmacist will check the ampoules are still clear and colourless before use. As with all medicines they will be kept out of the sight and reach of children. .

Further Information What Hemabate contains

The active substance in each ampoule is 250mcg of carboprost..

The other ingredients are sodium chloride (sodium content approximately 4.0mg/ml), water for injections , tromethamine and a preservative, benzyl alcohol (8.1 – 10.4 mg/ml). Small amounts of hydrochloric acid and sodium hydroxide, (used to regulate the acidity or alkalinity of the solution) may also be present.

What Hemabate looks like and contents of the pack

Hemabate is a colourless solution available in glass ampoules containing 1ml of solution. Hemabate comes in packs of two or ten ampoules.

Marketing Authorisation Holder: Pharmacia Limited Ramsgate Road Sandwich Kent CT13 9NJ Manufacturer:

Hemabate is made by

Pfizer Service Company BVBA Zaventem Belgium Company contact address:

For further information on your medicine contact Medical Information at the following address:

Pfizer Limited Walton Oaks Dorking Road Tadworth Surrey KT20 7NS Telephone:01304 616161

Leaflet last updated: June 2008

Ref: HM_003


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Buscopan Ampoules


Buscopan Ampoules

20 mg/ml Solution

for Injection

(hyoscine butylbromide)

Read all of this leaflet carefully before you start taking this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What BUSCOPAN Ampoules are and what they are used for 2. Before you receive BUSCOPAN Ampoules 3. How BUSCOPAN Ampoules will be given 4. Possible side effects 5. How to store BUSCOPAN Ampoules 6. Further information What Buscopan Ampoules Are And What They Are Used For

The name of your medicine is BUSCOPAN Ampoules 20 mg/ml Solution for injection (called BUSCOPAN Ampoules in this leaflet).

BUSCOPAN Ampoules contain a medicine called ‘hyoscine butylbromide’. This belongs to a group of medicines called ‘antispasmodics’.

BUSCOPAN Ampoules are used to relieve cramps in the muscles of your:

Stomach Gut (intestine) Bladder and the tubes leading to the outside of your body (urinary system)

BUSCOPAN Ampoules can also be used in some diagnostic and therapeutic medical procedures where spasm may be a problem for example barium enema.

Before You Receive Buscopan Ampoules You should not be given BUSCOPAN Ampoules if: You are allergic (hypersensitive) to hyoscine butylbromide or any of the other ingredients (listed in Section 6) You have glaucoma (an eye problem) You have megacolon (a very enlarged bowel) You have something called ‘myasthenia gravis’ (a very rare muscle weakness problem) You have a very fast heart rate You have difficulty or pain passing water (urine) such as men with prostate problems You have gut blockage problems or a totally inactive gut You are pregnant, likely to get pregnant or are breast-feeding

You should not receive this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Take special care with BUSCOPAN Ampoules

Check with your doctor or pharmacist before having this medicine if:

You have any heart problems You have a fever You have problems with your thyroid gland such as an overactive thyroid gland

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before receiving BUSCOPAN Ampoules.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because BUSCOPAN Ampoules can affect the way some other medicines work. Also some other medicines can affect the way BUSCOPAN Ampoules work.

In particular tell your doctor or pharmacist if you are taking any of the following:

Medicines for depression called ‘tricyclic antidepressants’ such as doxepin Medicines for allergies and travel sickness called ‘antihistamines’ Medicines to control your heart beat such as quinidine or disopyramide Medicines for severe mental illness such as haloperidol or fluphenazine Medicines for breathing problems such as salbutamol, ipratropium or tiotropium Amantadine - for Parkinson’s disease and flu Metoclopramide - for feeling sick (nausea)

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before receiving BUSCOPAN Ampoules.

Pregnancy and breast-feeding

You should not be given BUSCOPAN Ampoules if you are pregnant, likely to get pregnant or are breast-feeding.

Driving and using machines

Some people may have sight problems while taking this medicine. If this happens to you, wait until your sight returns to normal before driving or using any tools or machines.

Important information about some of the ingredients of BUSCOPAN Ampoules

BUSCOPAN Ampoules contain sodium chloride. The amount of sodium in a 1 ml ampoule is less than 1 mmol (23 mg), the total amount of sodium if you are given five ampoules in 24 hours is less than 1mmol (23 mg) this means that your medicine is essentially sodium free.

How Buscopan Ampoules Will Be Given

BUSCOPAN Ampoules are usually given by a doctor or nurse.

Receiving the injection

BUSCOPAN Ampoules may be given in two ways:

By being slowly injected into a vein By an injection into a muscle BUSCOPAN Ampoules may be diluted with other solutions if needed How much will you be given You will usually be given one ampoule, but you may be given a further ampoule after half an hour if required If you are being given BUSCOPAN Ampoules as part of an endoscopy your dose may need to be given more often You should not be given more than 5 ampoules in any 24-hour period

BUSCOPAN Ampoules are not recommended for children.

If you have more BUSCOPAN Ampoules than you should

It is unlikely that you will be given too much of this medicine. However, tell the doctor or nurse if you think that you have been given too much.

Buscopan Ampoules Side Effects

Like all medicines, BUSCOPAN Ampoules can cause side effects although not everybody gets them. The following side effects may happen with this medicine.

Stop taking your medicine and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment: Allergic reactions such as skin rash and itching Severe allergic reactions (anaphylaxis) such as difficulty breathing, feeling faint or dizzy (shock) Painful red eye with loss of vision Other side effects Dry mouth Dizziness Blurred vision Making less sweat than usual Increased heart rate Constipation Small blisters on hands and feet Being unable to pass water (urine) Low blood pressure, for example feeling faint Flushing

Pain at the place you had the injection may occur if you have been given BUSCOPAN Ampoules into a muscle.

Although unlikely, in certain circumstances it may be possible that BUSCOPAN may pass into the brain and cause side effects, for example confusion.

If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How To Store Buscopan Ampoules Keep out of the reach and sight of children Store below 30°C, keep the ampoules in the outer carton in order to protect from light BUSCOPAN Ampoules should not be used after the expiry date which is printed on the carton and ampoules. The expiry date refers to the last day of that month

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Further Information What BUSCOPAN Ampoules contain

Each ampoule contains 20 mg of the active ingredient hyoscine butylbromide. The other ingredients are sodium chloride and water for injections.

What BUSCOPAN Ampoules looks like and contents of the pack

BUSCOPAN Ampoules are clear glass ampoules containing a colourless or almost colourless, clear solution. BUSCOPAN Ampoules are supplied in cartons containing 10 x 1 ml ampoules.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisations are held by:

Boehringer Ingelheim Limited Ellesfield Avenue Bracknell Berkshire RG12 8YS United Kingdom

and the ampoules are manufactured at:

Boehringer Ingelheim Spain Tur? de can Matas Ctra. De. Rubi San Cugat del Valles Barcelona Spain

This leaflet was revised in April 2008.

© Boehringer Ingelheim Limited 2008

20080218

22C911


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Testosterone Enanthate Ampoules (Cambridge Laboratories)


What you should know about Testosterone Enantate Ampoules

Please read this leaflet carefully. This leaflet contains information about Testosterone Enantate Ampoules, which will be given to you by injection. Although you will not be taking this medicine yourself, this leaflet contains important information to help you understand how Testosterone Enantate is used. Keep it until the course of treatment has been finished, as you may want to read it again.

Always follow your doctor's advice, and if there is anything you do not understand, please ask your doctor or nurse to explain it.

What do Testosterone Enantate Ampoules contain?

Each ampoule contains 250 mg of Testosterone Enantate (the active ingredient) together with the inactive ingredients benzyl benzoate and castor oil for injection.

Testosterone Enantate is supplied in packs of 3 ampoules, each ampoule containing 1 ml.

Testosterone Enantate is an androgen, a male type of hormone.

The holder of the product licence for this medicine is

Cambridge Laboratories Limited Deltic House Kingfisher Way Silverlink Business Park Wallsend Tyne & Wear NE28 9NX

The ampoules are made by

Schering AG Berlin Germany What is Testosterone Enantate used for?

In men Testosterone Enantate is used when natural levels of this hormone are low, which can cause loss of interest in sex, low fertility and other problems. In women Testosterone Enantate is used to treat certain diseases of the breast.

When should Testosterone Enantate not be used?

Since androgens (male hormones) can stimulate the growth of cancer of the prostate gland, men must not be given Testosterone Enantate if they have prostatic cancer. For this reason, men should have regular examinations of the prostate gland during treatment with Testosterone Enantate. Men with breast cancer should not be given Testosterone Enantate.

Testosterone Enantate Ampoules should not be used to treat women who are pregnant or breast-feeding.

You should not be given Testosterone Enantate Ampoules if you have a liver tumour or a history of such tumours, if you have a kidney disease called nephrosis or if you have too much calcium in your blood.

What else should you know before having an injection of Testosterone Enantate?

Male hormones such as Testosterone Enantate are not suitable for increasing muscular development in healthy people or for increasing physical ability.

Special care is needed when Testosterone Enantate is used in the elderly and in patients with the following conditions:

Kidney problems Heart disease Liver disease High blood pressure Migraine Diabetes Cancer that has spread to the bones

If you suffer from any of these and think that the doctor who has prescribed Testosterone Enantate for you is not aware of this, you should tell him or her straight away.

Regular blood tests may be needed if you are also being treated with some medicines that slow down the clotting of the blood. Testosterone Enantate may be less effective in epileptic patients who are taking Phenobarbital, so if this applies to you please make sure that the doctor treating you knows about it.

How Testosterone Enantate is used

Testosterone Enantate is given by injection into a muscle, usually every 2 to 3 weeks. The injections are continued for as long as your doctor considers necessary, but men receiving long-term treatment may later be given injections at 3 to 6 week intervals.

If you would like any other information about the use of Testosterone Enantate, please ask your doctor or nurse.

Side-effects

When hormones such as Testosterone Enantate are used in high doses or over a long period of time, they may result in the retention of too much water, and even swelling of the ankles in some cases. If you have a tendency to this problem, make sure your doctor checks you very carefully while you are receiving treatment with Testosterone Enantate Ampoules.

Women who receive Testosterone Enantate may develop acne, increased growth of hair on the face and body, thinning of scalp hair and deepening of the voice (particular care is necessary in women whose occupations involve singing or speaking).

If men receive long-term and high-dose treatment with Testosterone Enantate, the number of sperms they produce is reduced. Men may experience frequent or persistent erections whilst under Testosterone Enantate treatment. If this happens, make sure to tell your doctor so that he may reduce the dose or stop the treatment in order to avoid injury to the penis.

Occasionally coughing, shortness of breath and changes in the circulation of the blood may develop while Testosterone Enantate is being injected or immediately after the injection.

The doctor may arrange for women receiving Testosterone Enantate to have regular blood tests. If these show an increased level of calcium, he will stop the treatment.

In very rare cases liver tumours have been observed after the use of hormones such as Testosterone Enantate. In a few isolated cases this has been followed by internal bleeding which can be life-threatening. Tell your doctor if you have any new "stomach" discomfort or pain that does not soon clear up.

Other side effects that have sometimes occurred with Testosterone Enantate are headache, depression, feeling sick, jaundice, breast enlargement in men, an increase in the number of red blood cells, anxiety, feeling weak, abnormal sensations, increased bone growth and premature sexual development in boys.

If you are worried about side-effects or if you think that Testosterone Enantate has caused any other side-effect, please tell your doctor, nurse or pharmacist about it.

Storing Testosterone Enanthate

Testosterone Enantate Ampoules should not be used after the expiry date given on the label. They should be stored away from light.

All medicines should be kept out of the reach of children.

Date of preparation of this leaflet: August 2001


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Water for Injections BP 2ml, 5ml, 10ml & 20ml


1. Name Of The Medicinal Product

Water for Injections B.P. 2ml, 5ml, 10ml & 20ml.

2. Qualitative And Quantitative Composition

Each 1ml of solution contains 1ml of Water for Injections B.P.

3. Pharmaceutical Form

Clear, colourless, odourless, sterile solution intended for parenteral administration to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

For the reconstitution, dilution and making-up of appropriate drugs where Water for Injections is the diluent of choice, and for use as an irrigant.

4.2 Posology And Method Of Administration

Route of administration: For S.C., I.M. or IV. injection, or as appropriate to the reconstituted drug.

Dosage: In accordance with the particular situation for which Water for Injections B.P. is being used.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

None.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

May be used during this period.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None known.

4.9 Overdose

No effects anticipated with the proposed use.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Not applicable.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Not applicable.

6.2 Incompatibilities

Water for Injections B.P. should not be mixed with any other agents unless their compatibility has been established.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

2ml, 5ml, 10ml and 20ml hermetically sealed translucent plastic ampoules, polypropylene Ph.Eur., packed in cardboard cartons to contain 10, 20, 50 and 100 ampoules.

6.6 Special Precautions For Disposal And Other Handling

For S/C, I/M or I/V Injection or as appropriate to the reconstituted drug.

If only part of an ampoule is used, discard the remaining solution.

Use as directed by the physician.

Keep out of reach of children.

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 2848/0152.

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorization : 10/10/91.

10. Date Of Revision Of The Text

August 2001


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Sterile Potassium Chloride Concentrate 15% (hameln)


Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What your medicine is and what it is used for 2. Before you receive it 3. How it is administered 4. Possible side effects 5. Storing your injection 6. Use by date Sterile Potassium Chloride Concentrate 15%

Each ml contains 0.15 g potassium chloride in a sterile solution for injection. The other ingredients are hydrochloric acid and water for injections.

Holder of the Marketing Authorisation: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln Pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany What potassium chloride is and what it is used for

Potassium chloride occurs naturally in your body.

It is used to replace the loss of potassium from your body, if this cannot be achieved when given by mouth or in the diet.

The injection is supplied in clear glass ampoules containing 10 ml.

10 ampoules are supplied in each carton.

Before the injection is given to you

Please tell your doctor, nurse or pharmacist before being given the injection if you:

suffer from impaired kidney function suffer from Addison's disease (a disease characterised by a reduced secretion of hormones from a gland situated near the kidneys) are very dehydrated suffer from heat cramps suffer from disturbances in the salt content of your blood are pregnant or breast-feeding

Please inform your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed, especially diuretics (water tablets) as these may interfere with this injection.

How the injection is given to you

Your doctor, nurse or pharmacist will give you the injection.

Sterile Potassium Chloride Concentrate 15% may be given by an intravenous injection (into a vein).

In emergencies, it may be necessary to give the injection without your knowledge.

Your doctor will decide on the correct dosage for you and when or how the injection will be given.

The injection must be diluted at least 50 times before it is given to you.

Possible side effects

Like all medicines, potassium chloride can have side effects.

Potassium chloride may cause the following side effects:

pain at the site of injection inflammation of the vein into which the solution is being injected raised blood levels of potassium

If you experience these or any other side effects not mentioned in this leaflet, please inform your doctor, nurse or pharmacist

Storing your injection

Your injection will be stored under 25°C, protected from light and out of the reach and sight of children.

Use by date

The doctor, nurse or pharmacist will check that the injection is not past its expiry date before giving you the injection.

This leaflet was last updated on March 25th 2004.

PL01502/0007R

43856/19/04


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Pabrinex Intravenous High Potency Injection


1. Name Of The Medicinal Product

Pabrinex Intravenous High Potency, Solution for injection

2. Qualitative And Quantitative Composition

Each presentation (carton) contains either 5ml or 10ml ampoules. Each pair of ampoules to be used in treatment is labelled Pabrinex No 1 and Pabrinex No 2.

Each No 1 ampoule contains: 5ml ampoule 10ml ampoule Thiamine Hydrochloride BP 250mg 500mg Riboflavin (as Phosphate Sodium BP) 4mg 8mg Pyridoxine Hydrochloride BP 50mg 100mg Each No 2 ampoule contains: 5ml ampoule 10ml ampoule Ascorbic Acid BP 500mg 1000mg Nicotinamide BP 160mg 320mg Anhydrous Glucose BP 1000mg 2000mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection

4. Clinical Particulars 4.1 Therapeutic Indications

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy; after acute infections, post-operatively and in psychiatric states. Also used to maintain levels of vitamin B and C in patients on chronic intermittent haemodialysis.

4.2 Posology And Method Of Administration

Pabrinex is also available as an Intramuscular High Potency Injection. Therefore before administration, ensure that both the Summary of Product Characteristics and ampoule labels refer to the INTRAVENOUS injection.

1) The preferred method of administration of Pabrinex Intravenous High Potency is by drip infusion. Equal volumes of the contents of ampoules number 1 and 2 should be added to 50ml to 100ml physiological saline or glucose 5% and infused over 30 minutes (see “Special Precautions for Storage” section).

2) For a combined injection volume of not more than 10ml (e.g. the contents of one 5ml ampoule number 1 and one 5ml ampoule number 2) the contents of the ampoules are drawn up into a syringe to mix them just before use, then injected slowly, over a period of 10 minutes, into a vein.

Adults:

Rapid therapy of severe depletion or malabsorption of the water soluble vitamins B and C, particularly in alcoholism, where a severe depletion of thiamine can lead to Wernicke's encephalopathy    

10ml solution from Ampoule

Number 1

PLUS

10ml solution from Ampoule

Number 2

OR

   

15ml solution from Ampoule

Number 1

PLUS

15ml solution from Ampoule

Number 2

2 to 3 pairs of 5ml ampoules* (1 pair = ampoule 1 + ampoule 2) diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) and administered over 30 minutes every 8 hours, or at the discretion of the physician.

* or equivalent volume of 5ml and/or 10ml ampoules

    Psychosis following narcosis or E.C.T; toxicity from acute infections    

5ml Ampoule Number 1

PLUS

5ml Ampoule Number 2

10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes twice daily for up to 7 days.

    Haemodialysis    

5ml Ampoule Number 1

PLUS

5ml Ampoule Number 2

10ml of the mixed ampoules diluted with 50ml to 100ml infusion solution (physiological saline or glucose 5%) administered over 15 to 30 minutes once every two weeks at the end of dialysis.

   

Elderly: as for adults.

Children: Pabrinex Intravenous High Potency is rarely indicated for administration to children, however suitable doses are as follows:

Under 6 years quarter of the adult dose 6 - 10 years third of the adult dose 10 - 14 years half to two thirds of the adult dose 14 years and over as for the adult dose 4.3 Contraindications

Known hypersensitivity to any of the active constituents or to the excipients.

4.4 Special Warnings And Precautions For Use

Although potentially serious allergic adverse reactions such as anaphylactic shock may occur rarely during, or shortly after, parenteral administration of Pabrinex, such rare occurrence of serious allergic reactions should not preclude the use of Pabrinex in patients who need treatment by this route of administration particularly those at risk of Wernicke's encephalopathy - for whom treatment with parenteral thiamine is essential. Initial warning signs of a reaction to Pabrinex are sneezing or mild asthma and those treating patients need to note that the administration of further injections to such patients may give rise to anaphylactic shock. Facilities for treating anaphylactic reactions should be available whenever Pabrinex Intravenous High Potency is administered. To minimise the risk of such events with Pabrinex Intravenous High Potency, the preferred mode of administration is by infusion over a period of 30 minutes.

This medicine is for injection into a vein only and should not be given by any other route

Care should be taken to ensure that the route of administration used (intramuscular or intravenous) is that intended – reports of unintentional administration by the wrong route have been received; these incidents have not been associated with serious adverse reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The content of pyridoxine may interfere with the effects of concurrent levodopa therapy.

4.6 Pregnancy And Lactation

No adverse effects have been noted at recommended doses when used as clinically indicated.

However animal studies are insufficient with respect to effects on pregnancy/ and-or/ embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (see section 5.3). The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. However given the nature of the product, no effects are anticipated.

4.8 Undesirable Effects

Occasionally, hypotension and mild paraesthesia from continued high doses of thiamine; occasionally mild ache at local site of injection.

4.9 Overdose

In the unlikely event of overdosage, treatment is symptomatic and supportive.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pabrinex Intravenous High Potency contains vitamins B1, B2, B6, nicotinamide, vitamin C and glucose.

ATC code: A11EB

5.2 Pharmacokinetic Properties

Not supplied.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Edetic acid

Sodium hydroxide

Water for Injections

6.2 Incompatibilities

If it is necessary to administer Pabrinex Intravenous High Potency in infusion, it is recommended that Pabrinex IV HP is administered in physiological saline or glucose 5%.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep the container in the outer carton. Do not freeze.

Storage of diluted Pabrinex Intravenous High Potency

The stability of Pabrinex Intravenous High Potency in intravenous infusion fluids, at room temperature, is as follows:

Intravenous infusion fluid

In the light

Glucose 5%

7 hours

Physiological saline (sodium chloride 0.9%)

7 hours

Glucose 4.3% with sodium chloride 0.18%

4 hours

Glucose 5% with potassium chloride 0.3%

4 hours

Sodium lactate M/6

7 hours

Although no further specific data are available, the solutions are expected to be stable for longer periods when protected from light. Store diluted solutions at 2°C to 8°C if not used immediately. Do not freeze.

6.5 Nature And Contents Of Container

Pabrinex Intravenous High Potency is supplied in pairs of amber glass ampoules of 5ml or 10ml. Pack sizes contain ten pairs of 5ml or five pairs of 10ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

In common with all parenteral products each ampoule should be visually inspected prior to administration and should not be used if particulates are present.

7. Marketing Authorisation Holder

Archimedes Pharma UK Limited

250 South Oak Way

Green Park

Reading

Berkshire

RG2 6UG

UK

8. Marketing Authorisation Number(S)

PL 12406/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: October 1993

Date of the latest renewal: October 2003

10. Date Of Revision Of The Text

22 July 2010


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Venofer IV Iron Sucrose


Vifor (International) Inc.

VENOFER 20 mg/ml injection

[Iron sucrose (iron (III) hydroxide sucrose complex)]

Please read this leaflet carefully. It contains a summary of the information available on Venofer 20 mg/ml injection which is part of your hospital treatment. If after reading this you have any questions ask the doctor or nurse.

In this leaflet 1. What Venofer is and what it is used for. 2. Before you receive Venofer. 3. How Venofer is administered. 4. Possible side effects of Venofer. 5. Storing Venofer. What Venofer is and what it is used for

Venofer is a sterile, dark brown, non transparent, aqueous solution of iron intended to be used only for intravenous injection or as a concentrate for solution for infusion which contains the active ingredient iron as a solution of iron sucrose (iron(III)-hydroxide sucrose complex). The solution also contains sodium hydroxide and water for injection.

Venofer is supplied in glass ampoules which contain 5ml of solution which is equivalent to 100mg of iron. The product is supplied in cardboard boxes each containing 5 ampoules.

Marketing authorisation holder: Vifor France SA 123, rue Jules Guesde 92300 Levallois-Perret France Manufacturer: ALTANA Pharma AG Byk-Gulden-Str. 2 D-78467 Konstanz Germany

Venofer provides a source of iron that can help to replenish a shortage of iron in patients with iron deficiency.

The product is intended for use only in the following circumstances:

in a patient known to be intolerant to iron preparations taken by mouth, in a patient where there is a specific clinical need to deliver iron rapidly to the iron stores, in a patient with active inflammatory bowel disease where iron preparations taken by mouth are ineffective or not tolerated. Before you receive Venofer You should be aware that: a blood test should have been carried out to ensure treatment with this medicine is appropriate, the product should not be given at the same time as other iron preparations taken by mouth, Venofer should not be administered during the first three months of pregnancy and it should be administered with caution during the fourth to ninth month. intramuscular or intravenous iron preparations can cause severe allergic or anaphylactoid reactions which may be potentially fatal. Therefore the medicine should only be given if there are appropriate medical facilities immediately available, allergic reactions, sometimes involving joint pain, have been more commonly observed when the recommended dose is exceeded. the product is not approved for use in children. You should not receive Venofer if: you are known to be sensitive (allergic) to any iron preparations intended for intramuscular or intravenous administration, you have a history of asthma, eczema or other atopic allergies because then you are more susceptible to experience allergic reactions, your anaemia is not due to a shortage of iron, you have a history of cirrhosis or hepatitis or have increased liver enzymes, you have any acute or chronic infections because these may be worsened by giving intramuscular or intravenous iron. How Venofer is administered

Venofer should only be administered by the intravenous route by slow intravenous injection or by intravenous drip infusion which is the preferred route. The product must not be administered by intramuscular or subcutaneous injection. For intravenous infusion the 5ml ampoule (100mg iron) should be diluted in 0.9% saline. No other intravenous dilution solutions or therapeutic agents should be used.

Before receiving your first dose, you should receive a small "test dose" which may help reduce the chance of a serious reaction occurring.

The total dose of Venofer you require is given in single doses of one ampoule not more than three times per week. This may be increased to two ampoules not more than three times per week depending on the severity of your iron deficiency. Your doctor will take responsibility for calculating the appropriate dose and frequency of injections.

Possible side effects of Venofer

The most commonly reported side effects of Venofer are temporary changes in taste, low blood pressure, fever, shivering, injection site reactions and nausea. Non-serious allergic reactions occurred rarely. In general, allergic reactions are potentially the most serious side effects. In these reactions, very rarely symptoms of low blood pressure, facial swelling and difficulty in breathing can be involved. See ‘Before you receive Venofer’ section 2.

The following possible side effects have been reported following the administration of Venofer:

Nervous system disorders

Common (greater than or equal to 1% and less than 10%): temporary changes in taste (in particular metallic taste).

Uncommon (greater than or equal to 0.1% and less than 1%) : headache; dizziness.

Rare (greater than or equal to 0.01% and less than 0.1%): tingling, “pins and needles”

Isolated cases: decreased alertness, light-headed feeling, confusion.

Heart and blood vessel disorders

Uncommon: low blood pressure and collapse; rapid heart beat, palpitations.

Lungs and airways disorders

Uncommon: wheezing, difficulty in breathing.

Stomach and intestine disorders

Uncommon: nausea; vomiting; abdominal (e.g. stomach) pain; diarrhoea.

Skin disorders

Uncommon: itching; hives; rash, redness.

Muscle, bone and joint disorders

Uncommon: muscle cramps, muscle pain.

Isolated cases: swelling of joints.

General disorders and administration site disorders

Uncommon: fever, shivering, flushing; chest pain and chest tightness. Burning, swelling and similar reactions (sometimes involving veins) around the site of injection.

Rare: allergic reactions (rarely involving joint pain); swelling of hands and feet; tiredness, weakness; general feeling of illness.

Isolated cases: face and tongue swelling.

Storing Venofer

Venofer is to be kept out of the reach and sight of children.

The product should not be used after the expiry date printed on the label. The ampoules should be stored below 25°C in the original cartons. The product should not be frozen. Once the ampoules have been opened they should be used immediately. After dilution with 0.9% saline the solution should be used immediately or within 3 hours if stored at room temperature.

Further information

This leaflet does not tell you everything about Venofer. If you have any questions or are not sure about receiving treatment with this medicine, then ask your doctor. Please keep this leaflet until your course of treatment with Venofer has been completed.

This Leaflet was approved:

United Kingdom: December 2003


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Fibro-Vein 3.0%, 1.0%, 0.5%, 0.2%


1. Name Of The Medicinal Product

Fibro-vein 3.0%, 1.0%, 0.5%, 0.2%

2. Qualitative And Quantitative Composition

Active ingredient

Fibro-vein 3% Sodium Tetradecyl Sulphate BP 3.0% w/v

Fibro-vein 1% Sodium Tetradecyl Sulphate BP 1.0% w/v

Fibro-vein 0.5% Sodium Tetradecyl Sulphate BP 0.5% w/v

Fibro-vein 0.2% Sodium Tetradecyl Sulphate BP 0.2% w/v

For excipients, see 6.1

3. Pharmaceutical Form

Intravenous injection

4. Clinical Particulars 4.1 Therapeutic Indications

Fibro-vein 3%

For the treatment of varicose veins of the leg by injection sclerotherapy.

Fibro-vein 1%

For the treatment of small varicose veins and the larger venules of the leg by injection sclerotherapy.

Fibro-vein 0.5%

For the treatment of minor venules and spider veins (venous flares) of the leg by injection sclerotherapy.

Fibro-vein 0.2%

For the treatment of minor venules and spider veins (venous flares) by injection sclerotherapy.

4.2 Posology And Method Of Administration

Route of administration

For intravenous administration into the lumen of an isolated segment of emptied vein followed by immediate continuous compression.

Recommended doses and dosage schedules.

Adults

Fibro-vein 3%

0.5 to 1.0ml of 3.0% Fibro-vein injected intravenously at each of 4 sites (maximum 4ml).

Fibro-vein 1%

0.25 to 1.0ml of 1.0% Fibro-vein injected intravenously at each of 10 sites (maximum 10ml).

Fibro-vein 0.5%

0.25 to 1.0ml of 0.5% Fibro-vein injected intravenously at each of 10 sites (maximum 10ml).

Fibro-vein 0.2%

0.1 to 1.0ml of Fibro-vein 0.2% injected intravenously at each of 10 sites (maximum 10ml).

The smallest of needles (30 gauge) should be used to perform the injection which should be made slowly so that the blood content of these veins is expelled. In the treatment of spider veins an air block technique may be used.

Children

Not recommended in children

The elderly

As for adults

4.3 Contraindications

1. Allergy to sodium tetradecyl sulphate or to any component of the preparation.

2. Patients unable to walk due to any cause.

3. Patients currently taking oral contraceptives.

4. Significant obesity.

5. Acute superficial thrombophlebitis.

6. Local or systemic infection.

7. Varicosities caused by pelvic or abdominal tumours.

8. Uncontrolled systemic disease eg diabetes mellitus.

9. Surgical valvular incompetence requiring surgical treatment.

4.4 Special Warnings And Precautions For Use

1. Fibro-vein should only be administered by practitioners familiar with an acceptable injection technique. Thorough pre-injection assessment for valvular competence and deep vein patency must be carried out.

Extreme care in needle placement and slow injection of the minimal effective volume at each injection site are essential for safe and efficient use.

2. A history of allergy should be taken from all patients prior to treatment. Where special caution is indicated a test dose of 0.25 to 0.5ml Fibro-vein should be given up to 24 hours before any further therapy.

3. Treatment of anaphylaxis may require, depending on the severity of attack, some or all of the following: injection of adrenaline, injection of hydrocortisone, injection of antihistamine, endotracheal intubation with use of a laryngoscope and suction.

The treatment of varicose veins by Fibro-vein should not be undertaken in clinics where these items are not readily available.

4. Extreme caution in use is required in patients with arterial disease such as severe peripheral atherosclerosis or thromboangiitis obliterans (Buerger's disease).

5. Special care is required when injecting above and posterior to the medial malleolus where the posterior tibial artery may be at risk.

6. Pigmentation may be more likely to result if blood is extravasated at the injection site (particularly when treating smaller surface veins) and compression is not used.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Do not use with heparin in the same syringe

4.6 Pregnancy And Lactation

Safety for use in pregnancy has not been established. Use only when clearly needed for symptomatic relief and when the potential benefits outweigh the potential hazards to the foetus.

It is not known whether sodium tetradecyl sulphate is excreted in human milk. Caution should be exercised when used in nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

1. Local: Pain or burning. Skin pigmentation. Tissue necrosis and ulceration may occur with extravasation. Paraesthesia and anaesthesia may occur if an injection effects a cutaneous nerve.

2. Vascular: Superficial thrombophlebitis. Deep vein thrombosis and pulmonary embolism are very rare. Inadvertent intra-arterial injection is very rare but may lead to gangrene. Most cases have involved the posterior tibial artery above the medial malleolus.

3. Systemic reactions: Allergic reactions are rare, presenting as local or generalised rash, urticaria, nausea or vomiting, asthma, vascular collapse. Anaphylactic shock, which may potentially be fatal, is extremely rare.

4.9 Overdose

Not applicable.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Sodium tetradecyl sulphate damages the endothelium cells within the lumen of the injected vein. The object of compression sclerotherapy is then to compress the vein so that the resulting thrombus is kept to the minimum and the subsequent formation of scar tissue within the vein produces a fibrous cord and permanent obliteration. Non-compressed veins permit the formation of a large thrombus and produce less fibrosis within the vein.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl Alcohol BP 2.0% w/v

Di-Sodium Hydrogen Phosphate BP 0.75% w/v

Potassium Di-Hydrogen Phosphate BP 0.1% w/v

Water For Injection BP to 100%

Potassium Di-Hydrogen Phosphate* BP qs

Sodium Carbonate (anhydrous)* BP qs

Sodium Hydroxide (5% soln)* BP qs

* Either sodium carbonate or sodium hydroxide is used for adjustment of pH

6.2 Incompatibilities

Do not use with heparin in the same syringe

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C away from direct sunlight

6.5 Nature And Contents Of Container

2ml ampoules type 1 neutral hydrolytic glass conforming with EP requirements for injectable preparations. Five 2ml ampoules per pack.

5ml glass vials type 1 neutral hydrolytic glass conforming with EP requirements for injectable preparations. Sealed with a chlorobutyl rubber bung and silver aluminium "tear off" seal conforming with the European Pharmacopoeia requirements. Ten 5ml vials per pack.

Fibro-vein 3.0% available as 5 x 2ml ampoules and 10 x 5ml vials

Fibro-vein 1.0% available as 5 x 2ml ampoules

Fibro-vein 0.5% available as 5 x 2ml ampoules

Fibro-vein 0.2% available as 5 x 2ml ampoules and 10 x 5ml vials

6.6 Special Precautions For Disposal And Other Handling

The in use period of each 5ml multidose vial is a single session of therapy and for use in the treatment of a single patient. Unused vial contents should be discarded immediately afterwards.

7. Marketing Authorisation Holder

STD Pharmaceutical Products Ltd

Plough Lane

Hereford

HR4 0EL

United Kingdom

8. Marketing Authorisation Number(S)

Fibro-vein 3.0% PL 0398/5000R

Fibro-vein 1.0% PL 0398/0003

Fibro-vein 0.5% PL 0398/0002

Fibro-vein 0.2% PL 0398/0004

9. Date Of First Authorisation/Renewal Of The Authorisation

Fibro-vein 3.0% 23/02/2006

Fibro-vein 1.0% 26/03/2008

Fibro-vein 0.5% 26/03/2008

Fibro-vein 0.2% 26/03/2008

10. Date Of Revision Of The Text

26/03/2008


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Dobutamine Concentrate 250 mg / 20 ml.


Dobutamine Concentrate

Important information about your medicine Your doctor or nurse will give you the injection If this injection causes you any problems talk to your doctor, nurse or pharmacist Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine Please tell your doctor or pharmacist, if you are taking any other medicines Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it. Keep this leaflet. You may need to read it again If you have any further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. Where to find information in this leaflet 1. What Dobutamine Concentrate is and what it is used for 2. Before you are given Dobutamine Concentrate 3. How to use Dobutamine Concentrate 4. Possible side effects 5. Storing Dobutamine Concentrate 6. Further information What Dobutamine Concentrate is and what it is used for

Dobutamine Concentrate belongs to a group of medicines known as inotropes, which make your heart beat more strongly. It is used:

in open heart surgery to treat heart disease to treat heart failure in shock as an alternative to exercise for stress testing the heart. Before you are given Dobutamine Concentrate You should NOT be given Dobutamine Concentrate if you: Are sensitive or allergic to Dobutamine Concentrate, sodium metabisulphite or any of the other ingredients in this injection. suffer from high blood pressure due to a tumour near the kidney (Phaeocromocytoma). Please tell your doctor or nurse before being given the injection if you: have recently had a heart attack are asthmatic have unstable angina have heart disease have high blood pressure have any condition that would make exercise dangerous for you. Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Dobutamine Concentrate:

beta blockers (medicines used to relieve certain heart conditions, anxiety and migraine). anaesthetics. entacapone (a medicine to treat Parkinson’s Disease). Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Dobutamine Concentrate.

How to use Dobutamine Concentrate

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given. Dobutamine Concentrate is not normally given to children.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, feel sick, are sick, feel anxious, feel palpitations, have a headache, feel short of breath or have chest pain you must tell the person giving you the injection.

Possible side effects

Like all medicines, Dobutamine Concentrate can cause side effects, although not everybody gets them.

Intravenous infusions may cause inflammation of the vein and damage to the skin at the injection site. The surrounding skin may feel warm and tender and redness may be present.

Death due to rupture of the heart muscle has occurred very rarely after giving dobutamine to assess the response of the heart to stress in patients with a recent heart attack. Your doctor will examine your heart before giving you Dobutamine Concentrate to decide if you are suitable to receive the drug.

The following side-effects have been reported: Hypersensitivity reactions involving rash and difficulty breathing including life threatening asthmatic episodes Changes in the levels of certain chemicals in the blood. Increased heart rate, palpitations, chest pain and changes to the rhythm of your heart. Changes to your blood pressure including both an increase and a decrease. difficulty in breathing (your breathing may stop) asthma headache nausea (feeling sick) Sudden, involuntary twitching of a muscle or group of muscles.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Storing Dobutamine Concentrate

Your injection will be stored at less than 21°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

Further information What Dobutamine Concentrate contains:

This injection contains the active ingredient dobutamine hydrochloride. Each 1 ml contains dobutamine hydrochloride equivalent to 12.5 mg dobutamine in a sterile solution for injection.

This injection contains the following inactive ingredients: sodium metabisulphite, sodium hydroxide, hydrochloric acid, sterile water for injections and carbon dioxide.

What Dobutamine Concentrate looks like and contents of the pack:

Dobutamine Concentrate is supplied in 20 ml clear glass ampoules, in cartons containing one, five or ten ampoules. Not all sizes may be marketed.

The marketing authorisation number of this medicine is: PL 01502/0054

Marketing Authorisation Holder: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved 12.08.2008

43821/20/09


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Atropine Sulphate Injection 600mcg in 1ml


Atropine Sulphate Injection

Important information about your medicine Your doctor or nurse will give you the injection. If this injection causes you any problems talk to your doctor, nurse or pharmacist. Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine. Please tell your doctor or pharmacist, if you are taking any other medicines. Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. Where to find information in this leaflet 1. What Atropine Sulphate Injection is and what it is used for 2. Before you are given Atropine Sulphate Injection 3. How to use Atropine Sulphate Injection 4. Possible side effects 5. Storing Atropine Sulphate Injection 6. Further information What Atropine Sulphate Injection is and what it is used for

Atropine Sulphate Injection belongs to a group of medicines known as anticholinergics.

It is used: before general anaesthesia to reduce saliva secretions. to restore normal heartbeat during a cardiac arrest. as an antidote to some insecticides and in mushroom poisoning. in combination with other drugs to reverse the effect of muscle relaxants used during surgery. Before you are given Atropine Sulphate Injection You should NOT be given Atropine Sulphate Injection if you: are sensitive or allergic to Atropine Sulphate Injection or any of the other ingredients in this injection. suffer from closed-angle glaucoma (a condition that affects your eyes). are a man with an enlarged prostate. suffer from myasthenia gravis (weakness of breathing muscles). suffer from pyloric stenosis (a narrowing of the opening that takes food away from your stomach). suffer from paralytic lleus (your intestine stops functioning properly). suffer from ulcerative colitis - a disease of the colon and rectum. Please tell your doctor or nurse before being given the injection if you have: urinary difficulties heart failure had a heart attack had a heart transplant chronic pulmonary obstructive disease (a condition where the airflow to your lungs is restricted and you may cough and feel breathless) an overactive thyroid high blood pressure fever diarrhoea reflux oesophagitis (heartburn) Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Atropine Sulphate Injection:

medicines to treat psychosis or depression. amantadine (a medicine for Parkinson's Disease) antihistamines (medicines used to treat hayfever and allergies medicines to regulate your heart (disopyramide and mexiletine) ketoconazole (a medicine to treat fungal infections). Medicines that you take by allowing them to dissolve slowly in your mouth - atropine may cause your mouth to become dry, making it more difficult for these medicines to dissolve. Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Atropine Sulphate Injection.

How to use Atropine Sulphate Injection

Your nurse or doctor will give you the injection

Your doctor will decide the correct dosage for you and how and when the injection will be given.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you feel your heart beating very fast, you are breathing quickly, have a high temperature, feel restless, confused, have hallucinations, or lose co-ordination you must tell the person giving you the injection.

Possible side effects

Like all medicines, Atropine Sulphate Injection can cause side effects, although not everybody gets them.

drowsiness blurred vision dry mouth with difficulty swallowing thirst dilation of the pupils flushing dryness of the skin slow heart beat followed by fast heart beat palpitations (you are aware of your heart beating) difficulty in passing urine or constipation vomiting rashes confusion

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Storing Atropine Sulphate Injection

Your injection will be stored at less than 25°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

Further information What Atropine Sulphate Injection contains:

This injection contains the active ingredient atropine sulphate. Each 1 ml of solution contains 600 micrograms in a sterile solution for injection.

This injection contains the following Inactive Ingredients: sulphuric acid and water for injections.

What Atropine Sulphate Injection looks like and contents of the pack:

Atropine Sulphate Injection is a supplied in 1 ml clear glass ampoules. 10 ampoules are supplied in each carton.

The marketing authorisation number of this medicine is: PL 01502/0016R

Marketing Authorisation Holder: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved 2008-08-18

44171/42/08


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Deca-Durabolin 50mg / ml


1. Name Of The Medicinal Product

Deca Durabolin 50mg/ml

2. Qualitative And Quantitative Composition

Each ml of Deca Durabolin contains 50mg nandrolone decanoate.

3. Pharmaceutical Form

Solution for injection.

4. Clinical Particulars 4.1 Therapeutic Indications

For use in osteoporosis in post-menopausal women.

Established osteoporosis should have been diagnosed by the following

parameters:

i) crush or wedge fractures of the vertebrae

ii) other osteoporotic fractures

iii) established reduction in bone mineral content as measured by accepted BMC measurements.

4.2 Posology And Method Of Administration

Dosage

Post-menopausal women

50 mg every three weeks.

The duration of treatment depends on the clinical response and the possible occurrence of side-effects.

We would recommend that the effectiveness of therapy be monitored with the appropriate methods for osteoporosis on a 6-12 monthly basis.

Children

There are no recommendations for use in children.

Administration

Deep intramuscular injection

4.3 Contraindications

Pregnancy

Breast-feeding

Porphyria

Allergies to any of the components

Known or suspected carcinoma of prostate or mammary carcinoma in the male

4.4 Special Warnings And Precautions For Use

If signs of virilisation develop, discontinuation of the treatment should be considered.

Patients, especially the elderly, with the following conditions should be monitored:

• latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions), since anabolic steroids may occasionally induce sodium and water retention;

• incomplete statural growth, since anabolic steroids in high dosages may accelerate epiphyseal closure;

• skeletal metastases, since anabolic steroids may induce hypercalcaemia and hypercalciuria in these patients;

• liver dysfunction - caution should be used in patients with severe hepatic impairment and Deca Durabolin 50mg/ml should only be used if the benefits outweigh the risks.

• diabetes mellitus

Deca Durabolin 50mg/ml contains Arachis oil (peanut oil) and should not be taken / applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Deca Durabolin 50mg/ml.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Anabolic steroids may improve glucose tolerance and decrease the need for insulin or other antidiabetic drugs in diabetics.

4.6 Pregnancy And Lactation

Deca-Durabolin is contra-indicated during pregnancy because of possible masculinisation of the foetus. There are insufficient data on the use of this medicine during breast-feeding to assess potential harm to the infant or a possible influence on milk production.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Deca-Durabolin at the recommended dosages is unlikely to produce virilising effects. High dosages, prolonged treatment and/or too frequent administration may cause:

• Virilisation which appears in sensitive women as hoarseness, acne, hirsutism and increase of libido; in prepubertal boys as an increased frequency of erections and phallic enlargement, and in girls as an increase of pubic hair and clitoral hypertrophy. Hoarseness may be the first symptom of vocal change which may end in long-lasting, sometimes irreversible deepening of the voice;

• Amenorrhoea and inhibition of spermatogenesis;

• Premature epiphyseal closure;

• Sodium and water retention.

Abnormal liver function tests have been reported in patients treated with (high doses) of Deca-Durabolin.

Liver tumours have been reported occasionally on prolonged treatment with orally active C17-alpha alkylated anabolic steroids. A relationship between liver tumours and non-C17-alkylated injectable steroids, such as nandrolone esters, appears to be highly unlikely, but cannot be absolutely excluded.

4.9 Overdose

The acute toxicity of nandrolone decanoate in animals is very low. There are no reports of acute overdosage with Deca-Durabolin in the human.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Nandrolone is chemically related to testosterone and shows enhanced anabolic and a reduced androgenic activity.

In humans Deca-Durabolin has been shown to positively influence calcium metabolism and to increase bone mass in osteoporosis.

Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17 alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestasis.

5.2 Pharmacokinetic Properties

Nandrolone decanoate is slowly released from the injection site into the blood with a half-life of 6 days. The ester is rapidly hydrolysed to nandrolone in the blood with a half-life of one hour or less. The half-life for the combined process of hydrolysis of nandrolone decanoate and of distribution and elimination of nandrolone is 4.3 hours.

Nandrolone is metabolised by the liver. 19-norandrosterone, 19-noretiocholanolone and 19-norepiandrosterone have been identified as metabolites in the urine. It is not known whether these metabolites display a pharmacological action.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl alcohol

Arachis oil

6.2 Incompatibilities

None known

6.3 Shelf Life

1 ml ampoule 60 months.

6.4 Special Precautions For Storage

Do not store above 30°C

Do not refrigerate or freeze.

Keep in the container in the outer carton.

6.5 Nature And Contents Of Container

1 x 1ml ampoules

3 x 1ml ampoules

6 x 1ml ampoules

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Organon Laboratories Limited,

Cambridge Science Park,

Milton Road,

Cambridge, CB4 0FL

8. Marketing Authorisation Number(S)

PL0065/5063R

9. Date Of First Authorisation/Renewal Of The Authorisation

28/2/73 / 27/04/05

10. Date Of Revision Of The Text

20 April 2010

11 Legal Category

Prescription Only Medicine

Ref:USDD50v4.2

RA 1220 GB S1 (ref 1.0)

DecaDurabolin/UK/04-10/1


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Sterile Potassium Chloride Concentrate 20% (hameln)


1. Name Of The Medicinal Product

Sterile Potassium Chloride Concentrate 20%.

2. Qualitative And Quantitative Composition

20% of Potassium Chloride in 5ml.

3. Pharmaceutical Form

Sterile Injection.

4. Clinical Particulars 4.1 Therapeutic Indications

Sterile Potassium Chloride Concentrate 20% is used as a source of the potassium cation for the treatment or prevention of potassium depletion in patients for whom dietary measures or oral medication are inadequate. Potassium salts may also be used cautiously in those taking digoxin where potassium depletion may cause arrhythmias. Sterile Potassium Chloride Concentrate 20% must be administered by slow I.V, as a dilute solution.

4.2 Posology And Method Of Administration

Adults (including elderly) and Children:

Sterile Potassium Chloride Concentrate 20% must be diluted by adding to a large volume of intravenous fluid before use. For example, 10mls diluted with not less than 700mls 0.9% Sodium Chloride Intravenous Infusion BP, or other suitable diluent, and mixed well.

Dosage depends on the serum ionogram value and the acid-base state. A potassium deficiency is calculated according to the formula:

MMOL Potassium = KG BW x 0.2 x 2 x (4.5 – actual serum potassium (MMOL)).

(The extracellular volume is calculated from the body weight in kg x 0.2).

The maximum dosage is 20 MMOL potassium per hour.

It is recommended not to exceed 2-3 MMOL potassium per kg body weight in 24 hours.

4.3 Contraindications

Hyperkalaemia, hyperchloraemia, impaired renal function with oliguria, anuria or azotaemia, Addison's disease, acute dehydration and heat cramps.

4.4 Special Warnings And Precautions For Use

Sterile Potassium Chloride Concentrate 20% must not be injected undiluted.

Plasma potassium concentration must be measured at regular intervals to avoid the development of hyperkalaemia, especially in patients with renal impairment.

ECG monitoring facilities should be available.

Initial potassium replacement therapy should not involve glucose infusions, because glucose may cause a further decrease in the plasma potassium concentration.

Potassium supplements should be administered with caution in patients with cardiac disease and in patients who are receiving potassium sparing diuretics or other medications which may increase plasma potassium levels.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Potassium sparing diuretics:

Potassium supplements should not be administered with potassium- sparing diuretics (such as amiloride, spironolactone and triamterene), particularly in patients with impaired renal function. Any patients on this combination require close monitoring in order to diagnose a potential hyperkalaemic condition as soon as possible.

Angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists:

Patients taking ACE-inhibitors or angiotensin II receptor antagonists, especially those with impaired renal function, should be closely monitored, as the potassium sparing effect in combination with potassium infusion may result in hyperkalaemia.

Ciclosporin:

Concurrent use of ciclosporin may increase the risk of hyperkalaemia.

Glucose Infusion:

Concomitant use of glucose infusions in hypokalaemic patients may cause a further decrease in plasma potassium concentrations.

4.6 Pregnancy And Lactation

Sterile Potassium Chloride Concentrate 20%, may be used during pregnancy and lactation under the supervision of the prescribing physician.

4.7 Effects On Ability To Drive And Use Machines

Not known.

4.8 Undesirable Effects

Pain at the injection site and phlebitis may occur during IV administration of solutions containing 30 MMOL potassium or more per litre.

Hyperkalaemia is the most common and serious hazard of potassium therapy.

4.9 Overdose

Clinical signs and symptoms of potassium overdosage include: Paraesthesia of the extremities, listlessness, mental confusion, weakness or heaviness of the legs, flaccid paralysis, cold skin, grey pallor, peripheral vascular collapse, fall in blood pressure, cardiac arrhythmias and heart block. Extremely high plasma potassium concentrations (8-11 MMOL/litre) may cause death from cardiac depression, arrhythmias or arrest.

Cardiac arrhythmias or a serum concentration above 6.5 MMOL/litre, require immediate attention and may be treated by intravenous injection over 1-5 minutes of 10 – 20 ml of 10% Calcium Gluconate Injection B.P. with E.C.G. monitoring. Serum concentrations may be reduced by infusion of 300 – 500 mls per hour of 10%-25% glucose solutions containing up to 10 units of insulin for each 20 g of glucose, or by the infusion of sodium bicarbonate solution.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Potassium is the major cation of intracellular fluid and is essential for maintenance of acid-base balance, isotonicity and the electrodynamic characteristics of the cell. Potassium chloride is used as a source of the potassium cation for treatment or prevention of potassium depletion in patients in whom dietary measures are inadequate. Potassium chloride may also be used cautiously to abolish arrhythmias or cardiac glycoside toxicity precipitated by a loss of potassium.

5.2 Pharmacokinetic Properties

Potassium chloride is generally readily absorbed from the gastro-intestinal tract. Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules which are also the site of sodium-potassium exchange. The capacity of the kidneys to conserve potassium is poor and urinary excretion of potassium continues even when there is severe depletion. Tubular secretion of potassium is influenced by several factors, including chloride ion concentration, hydrogen ion exchange, acid-base equilibrium and adrenal hormones. Some potassium is excreted in the faeces and small amounts may also be excreted in saliva, sweat, bile and pancreatic juice.

5.3 Preclinical Safety Data

No further information other than that which is included in the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Water for Injections Ph. Eur.

6.2 Incompatibilities

The compatibility of the large volume IV fluid intended for dilution should be checked before use.

6.3 Shelf Life

36 Months.

6.4 Special Precautions For Storage

Protect from light and store at less than 25°C.

6.5 Nature And Contents Of Container

5 and 10ml clear glass ampoules, hermetically sealed under flame at the gauging point. The ampoules are packed in cartons to contain 10 ampoules.

6.6 Special Precautions For Disposal And Other Handling

Use as directed by a physician.

ADMINISTRATIVE DATA 7. Marketing Authorisation Holder

hameln pharmaceuticals ltd

Gloucester

UK

8. Marketing Authorisation Number(S)

PL 01502/0015R

9. Date Of First Authorisation/Renewal Of The Authorisation

30th August 2001

10. Date Of Revision Of The Text

30/12/2008


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Adrenaline (Epinephrine) Injection BP 1 in 1000


Adrenaline (epinephrine) 1 in 1000 Injection

Important information about your medicine Your doctor or nurse will give you the injection. If this injection causes you any problems talk to your doctor, nurse or pharmacist. Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine. Please tell your doctor or pharmacist, if you are taking any other medicines. Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it. Keep this leaflet. You may need to read it again If you have any further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. Where to find information in this leaflet 1. What Adrenaline (epinephrine) 1 in 1000 Injection is and what it is used for 2. Before you are given Adrenaline (epinephrine) 1 in 1000 Injection 3. How to use Adrenaline (epinephrine) 1 in 1000 Injection 4. Possible side effects 5. Storing Adrenaline (epinephrine) 1 in 1000 Injection 6. Further information What Adrenaline (epinephrine) 1 in 1000 Injection is and what it is used for

Adrenaline is used in life-threatening emergencies such as acute allergic reactions.

It is an active chemical produced in the body. Adrenaline acts on receptors in the body and can increase the speed and force of heart muscle contractions, relieve narrowing of the lungs passages helping breathing and relieve some of the symptoms of acute allergic reaction.

Before you are given Adrenaline (epinephrine) 1 in 1000 Injection You should NOT be given Adrenaline (epinephrine) 1 in 1000 Injection if you: are sensitive or allergic to adrenaline or any of the other ingredients in this injection. Please tell your doctor or nurse before being given the injection if you: are in shock or have lost a lot of blood. have any heart disease. have Phaeochromocytoma (a tumour on the adrenal gland). have low blood levels of Potassium or high blood levels of Calcium. have a tumour on your prostate gland. are suffering from glaucoma (increased pressure in the eye). are going to have an operation under general anaesthetic. are a diabetic. are suffering from high blood pressure. Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Adrenaline (epinephrine) 1 in 1000 Injection:

Other medicines to treat high blood pressure or a heart condition. Corticosteroids (medicines used to treat inflammatory conditions in your body such as asthma or arthiritis). Aminophylline and Theophylline (medicines to help you breathe). Any cough or cold remedies. Antihistamines (for the treatment of allergies). Antidepressant medicines (for example; imipramine). Medicines to treat mental illness (for example; chlorpromazine, pericyazine, or fluphenazine). Medicines to treat an underactive thyroid gland. Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant. The doctor will then decide if the injection is suitable for you.

Please tell your doctor or nurse before being given this injection if you are breast feeding - this injection should not be used by nursing (breast feeding) mothers.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Adrenaline (epinephrine) 1 in 1000 Injection.

How to use Adrenaline (epinephrine) 1 in 1000 Injection

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you the injection.

Adrenaline must NOT be injected into fingers, toes, ears, nose or genitalia. Intramuscular injection in the buttocks should be avoided.

Possible side effects

Like all medicines, Adrenaline (epinephrine) 1 in 1000 Injection can cause side effects, although not everybody gets them.

Allergic reactions to Adrenaline and to Sodium Metabisulphite (contained in this injection) have been reported. The possibility of these should not stop you from using this injection for the treatment of serious allergic reactions or other emergency situations. Tell your doctor immediately if you have any difficulty breathing, a rash or itchy skin. You may suffer from anxiety, headache or tremors. If you suffer from Parkinson’s Disease, you may notice that the symptoms or rigidity and tremor get worse. You may feel weak or dizzy. High blood sugar levels may occur. Low blood levels of potassium may occur. Metabolic acidosis (an in-balance of certain constituents in your blood) may occur. You may experience a faster heart beat or high blood pressure. Chest pain may occur. In rare cases the increase in blood pressure following Adrenaline Injection has caused bleeding around the brain and paralysis. You may experience coldness of the extremities. You may experience difficulty in breathing or sweating. You may experience nausea or vomiting. There may be some tissue damage at the site of injection after repeated injections of adrenaline, and elsewhere in the body (for example; in the fingers and toes, liver and kidney). You may find it difficult to pass urine.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Storing Adrenaline (epinephrine) 1 in 1000 Injection

Your injection will be stored in a cool place and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

Further information What Adrenaline (epinephrine) 1 in 1000 Injection contains:

Each ml of solution for injection contains 1 mg of adrenaline (epinephrine) as the acid tartrate.

Adrenaline Injection contains the following inactive ingredients: sodium metabisulphite, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

What Adrenaline (epinephrine) 1 in 1000 Injection looks like and contents of the pack:

The injection is supplied in 1 ml clear glass ampoules. 10 ampoules supplied in each carton.

The marketing authorisation number of this medicine is: PL 01502/0024

Marketing Authorisation Holder: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved 03.03.2009

43823/20/09


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Furosemide Injection BP


Furosemide Injection

Important information about your medicine Your doctor or nurse will give you the injection If this injection causes you any problems talk to your doctor, nurse or pharmacist Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine Please tell your doctor or pharmacist, if you are taking any other medicines Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it. Keep this leaflet. You may need to read it again If you have any further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. Where to find information in this leaflet 1. What Furosemide Injection is and what it is used for 2. Before you are given Furosemide Injection 3. How to use Furosemide Injection 4. Possible side effects 5. Storing Furosemide Injection 6. Further information What Furosemide Injection is and what it is used for

Furosemide Injection is a powerful, quick acting diuretic which causes the body to increase the production of urine. It is used to:

remove large amounts of fluid that has accumulated in the tissues and lungs (oedema) treat high blood pressure in emergencies increase the production of urine in kidney failure Before you are given Furosemide Injection You should NOT be given Furosemide Injection if you: Are sensitive or allergic to Furosemide Injection or any of the other ingredients in this injection. If you are allergic to a group of drugs called sulphonamides (e.g. Co-Trimoxazole) you may also be allergic to this injection. You are dehydrated, your blood volume is low (you may feel dizzy, faint or have pale skin) or you are unable to pass urine. You have low levels of potassium or sodium or an imbalance of chemicals in your blood. You have liver cirrhosis that is affecting your consciousness. You previously received certain medicines that have damaged your kidneys. Please tell your doctor or nurse before being given the injection if you have: You have hypotension (low blood pressure) You have (or potentially may have) diabetes You have gout You have (or have had) any problems with your liver or kidneys You have difficulty in passing water, for example because of a large prostate gland Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Furosemide Injection:

medicines to help your heart beat (e.g. digoxin) medicines to help your heart beat regularly (e.g. amiodarone) medicines to lower your blood pressure particularly medicines known as ACE inhibitors or angiotensin II receptor antagonists lithium medicines used to treat pain or inflammation (e.g. indometacin, ketorolac, acetylsalicylic acid) antibiotics cisplatin methotrexate ciclosporin medicines to treat epilepsy e.g. phenytoin, carbamazepine corticosteroids chloral hydrate or triclofos medicines to relax your muscles Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Furosemide Injection.

How to use Furosemide Injection

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you the injection.

During treatment with Furosemide Injection, your doctor may want you to have blood tests to show if the chemicals and fluids in your body are balanced.

If Furosemide injection is given to a premature infant then the doctor will monitor the infant’s kidneys to ensure that the Furosemide injection is not causing any problems.

Possible side effects

Like all medicines, Furosemide Injection can cause side effects, although not everybody gets them.

allergic reactions such as rash, itching, difficulty breathing or swelling of the face or lips feeling sick, diarrhoea blurred vision, headache skin rashes, including blistering and sensitivity/over reacting to sunlight muscle spasms or cramps caused by chemical imbalances in the blood and body fluids hearing problems (such as deafness or ringing in the ears) aching or swollen joints (gout) high blood sugar, sugar in the urine low blood pressure which may cause dizziness when standing up Inflammation of the pancreas, kidneys or blood vessels deposits of calcium in the kidneys changes in the blood which may cause increased bleeding or bruising, or make you more likely to catch infections increased levels of cholesterol or triglycerides in the blood. changes in the rhythm of your heart. greater difficulties for patients with existing problems in passing urine (e.g. enlarged prostate).

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Storing Furosemide Injection

Your injection will be stored at less than 25°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

Further information What Furosemide Injection contains:

This injection contains the active ingredient furosemide. Each 1 ml of solution contains 10 mg furosemide in a sterile solution for injection.

This injection contains the following inactive ingredients: sodium chloride, sodium hydroxide and sterile water for injections.

This injection contains a maximum of 4 mg of sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

What Furosemide Injection looks like and contents of the pack:

Furosemide Injection is supplied in 2 ml, 5 ml and 25 ml amber glass ampoules. The injection is supplied in cartons of 10 ampoules. Not all ampoule sizes may be marketed.

The marketing authorisation number of this medicine is: PL 01502/0032

Marketing Authorisation Holder: hameln pharmaceuticals ltd Gloucester United Kingdom Manufacturer: hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved 19.08.2008

44174/20/09


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Ismelin ampoules 10mg / ml


1. Name Of The Medicinal Product

Ismelin®ampoules l0mg/ml

2. Qualitative And Quantitative Composition

Guanethidine monosulphate Ph.Eur. 10mg/ml

3. Pharmaceutical Form

A colourless solution in a clear glass l ml ampoule, for intramuscular administration.

4. Clinical Particulars 4.1 Therapeutic Indications

Control of hypertensive crises, and to obtain more rapid blood pressure control.

4.2 Posology And Method Of Administration

Adults:

Ismelin should be given by intramuscular injection. One injection of 10 to 20mg will generally cause a fall in blood pressure within 30 minutes which reaches a maximum in one to two hours and is maintained for four to six hours. If a further dose of 10 to 20mg is deemed necessary, then three hours should be allowed to elapse between doses.

In hypertensive patients with moderate renal insufficiency, the intervals between dosing should be extended or the dosage reduced to avoid accumulation as the drug is renally excreted. (For patients with renal failure, see Section 4.3, "Contra

Children: not recommended.

Elderly: Clinical evidence would indicate that no special dosage regime is necessary, but concurrent coronary or cerebral insufficiency should be taken into account.

4.3 Contraindications

Cases of phaeochromocytoma and patients previously treated with monoamine oxidase inhibitors (see Section 4.5, "Interactions with other medicaments and other forms of interaction"); in such cases, Ismelin may lead to the release of large quantities of catecholamines, which may cause a hypertensive crisis.

Patients with known hypersensitivity to guanethidine and related derivatives. Heart failure due to causes other than hypertension. Renal failure (creatinine clearance 10 to 40ml/min).

4.4 Special Warnings And Precautions For Use

Heat and physical exertion may increase the antihypertensive effect of Ismelin.

Ismelin should be used with caution in patients with moderate renal insufficiency (creatinine clearance 41 to 65ml/min), or with coronary and/or cerebral arteriosclerosis; abrupt lowering of blood pressure should be avoided. Caution should be exercised in asthmatic patients or in patients with a history of gastro

The concurrent administration of guanethidine and ?

When patients have to undergo surgery, it is recommended that treatment with Ismelin be withdrawn a few days before the operation. To avoid excessive bradycardia during anaesthesia, it is advisable to premedicate with larger than usual doses of atropine.

After prolonged treatment with Ismelin, latent heart failure may develop. This is due to salt and water retention, and mild negative inotropic and chronotropic effects. Concomitant administration of diuretics can readily correct this condition.

If patients develop fever, the dose of Ismelin should be lowered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Monoamine oxidase inhibitors should be withdrawn at least fourteen days before starting treatment with Ismelin (See Section 4.3, "Contra

Concurrent administration of Ismelin with anti

The anti-hypertensive action of Ismelin may be enhanced by other anti-hypertensive agents such as reserpine, methyldopa, vasodilators (especially minoxidil), calcium antagonists, ?

The anti-hypertensive action of Ismelin may be reduced by chlorpromazine, phenothiazine derivatives, tricyclic antidepressants and related anti-psychotic drugs, and oral contraceptives. Consequently if larger doses of Ismelin are prescribed, care must be taken upon the withdrawal of any of the drugs listed, as severe hypotension may ensue if the dose of Ismelin is not adjusted in advance.

After prolonged treatment with Ismelin, it may be necessary to adjust the dosage of insulin or oral anti

Patients on Ismelin may become hypersensitive to adrenaline, amphetamines or other sympathomimetic agents. Therefore caution should be exercised when taking or using preparations containing these drugs.

4.6 Pregnancy And Lactation

No foetal toxicity or fertility studies have been carried out in animals. Therefore the drug should only be used if there is no safer alternative. However, in particular, it should not be used during the first trimester of pregnancy nor within at least two weeks prior to the birth or during labour since it may induce paralytic ileus in the newborn infant.

In mothers receiving Ismelin in therapeutic doses, the active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.

4.7 Effects On Ability To Drive And Use Machines

Patients should be warned of the potential hazards of driving or operating machinery if they experience side effects such as dizziness, blurred vision or drowsiness.

4.8 Undesirable Effects

Side effects are often an indication of excessive dosage. The following effects may occur:

Central nervous system: Particularly at the start of treatment: dizziness, tiredness, lethargy, paraesthesia and headache. Occasional: blurred vision and depression. Rare: myalgia and muscular tremor.

Cardiovascular system: Postural hypotension (which may be associated with cerebral or myocardial ischaemia in severe cases) especially when getting up in the morning or after physical exertion, sick

Gastro Diarrhoea and gaseous distension. Occasional: vomiting, nausea and dry mouth. Rare: swelling of parotid glands.

Respiratory tract: Nasal congestion. Rare: asthma.

Urogenital system: Raised BUN levels or uraemia in patients with latent or manifest renal failure, and ejaculation disturbances.

Skin and hair: Occasional: dermatitis. Rare: hair loss.

Blood: Isolated reports of anaemia, leucopenia, and/or thrombocytopenia.

4.9 Overdose

Symptoms: may include postural hypotension which may cause syncope, sinus bradycardia (although tachycardia has been observed), tiredness, dizziness, blurring of vision, muscular weakness, nausea, vomiting, severe diarrhoea and oliguria.

Treatment: Postural hypotension may be overcome by keeping the patient recumbent, or by instituting fluid and electrolyte replacement, and if necessary, by cautious administration of pressor agents (see Section 4.5, "Interactions with other medicaments and other forms of interaction"). Sinus bradycardia can be treated with atropine, and diarrhoea with an anticholinergic agent.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Ismelin is a peripheral sympathetic blocking drug which lowers blood pressure by depleting and inhibiting reformation of noradrenaline in postganglionic nerve endings. Guanethidine, being highly polar, does not cross the blood

5.2 Pharmacokinetic Properties

Guanethidine may be excreted more slowly in those patients with moderate to severely compromised renal function, therefore the potential for accumulation of the drug will be higher.

5.3 Preclinical Safety Data

There are no pre

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium chloride, sulphuric acid and water for injections.

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Clear glass type I, l ml ampoules containing l0mg/ml: Boxes of 5.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data 7. Marketing Authorisation Holder

Amdipharm Plc

Regency House

Miles Gray Road

Basildon

Essex SS14 3AF

United Kingdom

8. Marketing Authorisation Number(S)

PL 20072/0027

9. Date Of First Authorisation/Renewal Of The Authorisation

18th April 2005

10. Date Of Revision Of The Text Legal Status

POM


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Ventolin Solution for IV Infusion


Ventolin Solution for Intravenous Infusion

1 mg/ml

salbutamol sulphate

Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, nurse or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1 What Ventolin Infusion is and what it is used for 2 Before you use Ventolin Infusion 3 How to use Ventolin Infusion 4 Possible side effects 5 How to store Ventolin Infusion 6 Further information What Ventolin Infusion is and what it is used for

Ventolin Solution for Intravenous Infusion (called ‘Ventolin Infusion’ in this leaflet) contains a medicine called salbutamol. This belongs to a group of medicines called ‘beta-agonists’. It acts on special receptor sites in the lungs and in the uterus (in women) to:

help the airways in your lungs to stay open. This makes it easier for air to get in and out. It helps to relieve chest tightness, wheezing and cough relax the muscles in the walls of the uterus.

This may stop the contractions associated with labour.

Ventolin Infusion is used: to treat severe breathing problems in people with asthma and similar conditions to stop premature labour. Before you use Ventolin Infusion Do not use Ventolin Infusion if: you are allergic (hypersensitive) to salbutamol sulphate or any of the other ingredients of Ventolin Infusion (listed in Section 6). Take special care with Ventolin Infusion

Check with your doctor, nurse or pharmacist before taking your medicine if:

you have high blood pressure you are diabetic you have an overactive thyroid gland you have a history of heart problems such as an irregular or fast heartbeat or angina. Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

In particular tell your doctor, nurse or pharmacist if you are taking:

medicines for an irregular or fast heartbeat other medicines for your asthma.

Ventolin Infusion should not be administered in the same syringe or infusion as any other medication.

Using Ventolin with food and drink

You can use Ventolin Infusion at any time of day, with or without food.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.

Driving and using machines

Ventolin is not likely to affect you being able to drive or use any tools or machines.

How to use Ventolin Infusion

You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.

The Ventolin Infusion will be diluted before it is given to you. Your doctor or nurse will find information about how to dilute the medicine in the Summary of Product Characteristics (SPC).

To treat severe breathing problems The usual dose is 3 to 20 micrograms of salbutamol per minute for as long as required. Higher doses may be used in patients with ‘respiratory failure’. To treat premature labour The usual dose is 10 to 45 micrograms of salbutamol per minute until contractions stop. If your labour continues despite this treatment then the infusion should be stopped.

Ventolin Solution for Intravenous Infusion is not suitable for treating children.

If you receive more Ventolin Infusion than you should

Ventolin Infusion will always be given under carefully controlled conditions. However, if you think that you have been given more than you should tell your doctor or nurse as soon as possible.

The following effects may happen:

your heart beating faster than usual you feel shaky.

These effects usually wear off in a few hours.

If you stop taking Ventolin Infusion

Do not stop taking Ventolin without talking to your doctor.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

Possible side effects

Like all medicines, Ventolin Infusion can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Allergic reactions (affects less than 1 in 10,000 people)

If you have an allergic reaction, stop taking Ventolin and see a doctor straight away. Signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed, and collapse.

Talk to your doctor as soon as possible if: you feel your heart is beating faster or stronger than usual (palpitations). This is usually harmless, and usually stops after you have used the medicine for a while you may feel your heartbeat is uneven or it gives an extra beat these affect less than 1 in 10 people.

If any of these happen to you, talk to your doctor as soon as possible. Do not stop using this medicine unless told to do so.

Tell your doctor if you have any of the following side effects which may also happen with this medicine:

Very common (affects more than 1 in 10 people)

feeling shaky.

Common (affects less than 1 in 10 people)

headache muscle cramps.

Uncommon (affects less than 1 in 100 people)

patients receiving Ventolin Infusion for the treatment of premature labour: cough, wheezing, chest pain or shortness of breath, which may be signs of pulmonary oedema (fluid in the lungs). Tell your doctor immediately.

Rare (affects less than 1 in 1,000 people)

low level of potassium in your blood increased blood flow to your extremities (peripheral dilatation).

Very rare (affects less than 1 in 10,000 people)

changes in sleep patterns and changes in behaviour, such as restlessness and excitability. The following side effects can also happen but the frequency of these are not known: in the treatment of premature labour feeling sick and being sick (nausea and vomiting) chest pain, due to heart problems such as angina. Tell your doctor, nurse or pharmacist if this occurs. Do not stop using this medicine unless told to do so a condition known as lactic acidosis which may cause stomach pain, hyperventilation, shortness of breath, cold feet and hands, irregular heartbeat or thirst.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

If you think this medicine is not working well enough for you

If your medicine does not seem to be working as well as usual, talk to your doctor as soon as possible. Your chest problem may be getting worse and you may need a different medicine.

Do not take extra Ventolin unless your doctor tells you to.

How to store Ventolin Infusion Keep out of the reach and sight of children. Do not store above 30°C. Keep the ampoules in the outer carton to protect from light. Use the medicine within 24 hours of mixing with infusion fluids. Do not use Ventolin Infusion after the expiry date, which is stated on the ampoule label and carton after ‘EXP’. The expiry date refers to the last day of that month. If you are told to stop taking this medicine return any unused Ventolin Infusion to your pharmacist to be destroyed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

Further information What Ventolin Infusion contains The active substance is salbutamol sulphate. The other ingredients are water, salt (sodium chloride) and sulphuric acid. What Ventolin Infusion looks like and contents of the pack

Ventolin Infusion comes in a 5 ml glass ampoule.

Each 5 ml ampoule contains 5 mg of salbutamol sulphate in sterile normal saline adjusted to pH 3.5.

Each carton contains 10 ampoules.

Marketing Authorisation Holder Glaxo Wellcome UK Limited trading as: Allen & Hanburys Stockley Park West Uxbridge Middlesex UB11 1BT Manufacturer GlaxoSmithKline Manufacturing S.p.A. San Polo di Torrile Parma Italy

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Ventolin Infusion

Reference number 10949/0087

This is a service provided by the Royal National Institute of Blind People.

Leaflet date: January 2008

Ventolin is a trademark of the GlaxoSmithKline group of companies

© 2008 GlaxoSmithKline group of companies

10000000060960


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Glyceryl Trinitrate 1mg / ml solution for infusion


1. Name Of The Medicinal Product

Glyceryl Trinitrate 1 mg/ml solution for infusion

2. Qualitative And Quantitative Composition

1 ml solution contains 1 mg glyceryl trinitrate.

Amount of active substance per pack size:

Total Volume

Total GTN Content

Container

5ml

5mg

ampoule

10ml

10mg

ampoule

25ml

25mg

ampoule

50ml

50mg

vial

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for infusion

The product is a clear and colourless solution.

4. Clinical Particulars 4.1 Therapeutic Indications

The following indications exist for Glyceryl Trinitrate:

- Unresponsive congestive heart failure, including that secondary to acute myocardial infarction; acute left-sided heart failure and acute myocardial infarction,

- Refractory unstable angina pectoris and coronary insufficiency, including Prinzmetal's angina,

- Control of hypertensive episodes and/or myocardial ischaemia during and after cardiac surgery,

- Induction of controlled hypotension for surgery.

4.2 Posology And Method Of Administration

For intravenous use. Glyceryl Trinitrate should be administered by means of a micro-drip set infusion pump or similar device which permits maintenance of constant infusion rate.

For instructions on dilution of the product before administration, see section 6.6.

Adults and the elderly - the dose should be titrated against the individual clinical response.

Unresponsive congestive heart failure, acute myocardial infarction and left-sided heart failure. The normal dose range is 10-100 micrograms / minute administered as a continuous intravenous infusion with frequent monitoring of blood pressure and heart rate. The infusion should be started at the lower rate and increased cautiously until the desired clinical response is achieved. Other haemodynamic measurements are extremely important in monitoring response to the drug: These may include pulmonary capillary wedge pressure, cardiac output and precordial electrocardiogram depending on the clinical picture.

Refractory unstable angina pectoris. An initial infusion rate of 10-15 micrograms / minute is recommended; this may be increased cautiously in increments of 5-10 micrograms until either relief of angina is achieved, headache prevents further increase in dose, or the mean arterial pressure falls by more than 20 mm Hg.

Use in surgery. An initial infusion rate of 25 micrograms / minute is recommended; this should be increased gradually until the desired systolic arterial pressure is attained. The usual dose is 25-200 micrograms / minute.

Children – Glyceryl Trinitrate 1 mg/ml solution for infusion is not recommended for use in children.

4.3 Contraindications

Glyceryl Trinitrate should not be used in the following cases: Known hypersensitivity to nitrates, severe anaemia, severe cerebral haemorrhage, head trauma, uncorrected hypovolaemia and hypotensive shock, arterial hypoxaemia and angina caused by hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, toxic pulmonary oedema. Sildenafil potentiates the hypotensive effects of nitrates and its co-administration with Glyceryl Trinitrate is contraindicated.

Glyceryl Trinitrate should be administered with caution and under continuous monitoring to patients with acute left-sided heart failure or acute myocardial infarction and only when the systolic blood pressure exceeds 90 mm Hg.

4.4 Special Warnings And Precautions For Use

Caution should be exercised in patients with severe liver or renal disease, hypothermia, hypothyroidism.

Glyceryl Trinitrate should not be given by bolus injection.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Glyceryl trinitrate may potentiate the action of other hypotensive drugs, and the hypotensive and anticholinergic effects of tricyclic antidepressants; it may also slow the metabolism of morphine-like analgesics.

The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil. A severe and possibly dangerous fall in blood pressure may occur. This can result in collapse, unconsciousness and may be fatal. Such use is therefore contraindicated (section 4.3).

4.6 Pregnancy And Lactation

This product should not be used in pregnancy or in women who are breast feeding infants unless considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

Not applicable, because the product is used in hospitalised patients.

4.8 Undesirable Effects

Frequencies of the adverse reactions are listed according to the following convention:

Very common (

Common (

Uncommon (

Rare (

Very rare (< 1/10000),

Not known (cannot be estimated from the available data).

Nervous system disorders:

Very Common: Headache*

Cardiac disorders:

Common: Paradoxical Bradycardia

Uncommon: Tachycardia*

Vascular disorders:

Very common: Hypotension*

Common: Dizziness*

Gastrointestinal disorders:

Common: Nausea

Not known: Retrosternal discomfort

General disorders and administration site conditions:

Not known: Diaphoresis, Flushing*, Restlessness, Abdominal pain

*particularly if the infusion is administered too rapidly.

These symptoms should be readily reversible on reducing the rate of infusion or, if necessary, discontinuing treatment.

4.9 Overdose

Signs and symptoms: Vomiting, restlessness, hypotension, syncope, cyanosis, coldness of the skin, impairment of respiration, bradycardia, psychosis and methaemoglobinaemia may occur.

Treatment: The symptoms may be readily reversed by discontinuing treatment; if hypotension persists, raising the foot of the bed and the use of vasoconstrictors such as intravenous methoxamine or phenylephrine are recommended. Methaemoglobinaemia should be treated by intravenous methylene blue. Oxygen and assisted respiration may be required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC-Code: C01DA02 Organic nitrates

Glyceryl trinitrate exerts a spasmolytic action on smooth muscle, particularly in the vascular system. This action is more marked on the venous capacitance vessels than the arterial vessels; the predominant increase in venous capacitance results in marked diminution of both the left ventricular filling pressure and volume (preload). The moderate dilation of the arteriolar resistance vessels results in a reduction in afterload. These haemodynamic changes (reductions) in preload and afterload lower the myocardial oxygen demand. In addition, by direct action and through the reduction of myocardial wall tension glyceryl trinitrate also lowers the resistance to flow in the coronary collateral channels and allows re-distribution of blood flow to ischaemic areas of the myocardium.

Administration of glyceryl trinitrate by intravenous infusion to patients with congestive heart failure results in a marked improvement in haemodynamics, reduction of elevated left ventricular filling pressure and systolic wall tension, and an increase in the depressed cardiac output. It reduces the imbalance that exists between myocardial oxygen demand and delivery, thereby diminishing myocardial ischaemia and controlling ischaemia-induced ventricular arrhythmias.

Glyceryl trinitrate relaxes smooth muscles cells in other organs to some extent. The cellular molecular mechanism of action is a synthesis of nitric oxide and cyclic guanosyl monophosphate which acts as a mediator for muscle relaxation.

5.2 Pharmacokinetic Properties

After intravenous administration, glyceryl trinitrate is widely distributed in the body with an estimated apparent volume of distribution of approximately 200 litres. It is strongly bound to erythrocytes and vessel walls; the plasma protein binding is approx. 60%. The therapeutic plasma concentration range is 0.1 to 3 ng/ml (up to 5 ng/ml).

Glyceryl trinitrate is rapidly metabolised to dinitrate and mononitrate and further metabolised by glucuronidation in the liver, showing a marked first-pass effect.

Spontaneous hydrolysis occurs in plasma. The estimated plasma half-life of glyceryl trinitrate is 1 to 4 minutes. The rapid disappearance from plasma is consistent with the high systemic clearance values (up to 3270 litres per hour). The less active metabolites resulting from biotransformation can be recovered from the urine within 24 hours.

5.3 Preclinical Safety Data

The acute toxicity has been reported for rats after intravenous (LD50 17-41 mg/kg body weight), as well as in dogs after intravenous administration (LD50 19-24 mg/kg body weight). Autopsy did not reveal any pathological findings.

Subacute studies in rats at doses of 2.5, 5.0 and 10.0 mg/kg per day, and in dogs at doses of 1.0 and 3.0 mg/kg per day elicited only minimal reactions. In rats, suppression of body weight gain and food consumption occurred among treated and vehicle-control animals. Mild tissue irritation at injection sites was noted in treated and vehicle-control groups. There were no clearly drug-related clinical or pathological findings in dogs. Further results of studies on repeated-dose toxicity in different species revealed no indication of drug-specific clinically relevant toxicity.

Glyceryl trinitrate is insufficiently tested for a potential mutagenic action. There are no adequate state-of-the-art long-term studies on a possible tumourigenic action of glyceryl trinitrate.

There is inadequate experience with glyceryl trinitrate during human pregnancy, particularly during the first trimester. Sufficient evidence is available from animal studies with intravenous, intraperitoneal and topical administration. Studies on fertility and embryotoxicity did not result in any toxic effect on the embryo or on reproductive performance. Any indication of a teratogenic potential of glyceryl trinitrate was not found. Doses in excess of 1 mg/kg/day (i.p.) or 28 mg/kg/day (topical) reduced the birth weight in rats. There are no investigations on the passage of glyceryl trinitrate into breast milk.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Water for injections

Glucose monohydrate

Hydrochloric acid

6.2 Incompatibilities

Glyceryl Trinitrate is not compatible with polyvinylchloride (PVC) and severe losses of glyceryl trinitrate (up to 50%) may occur if polyvinylchloride is used, resulting in a reduction of delivered dose and efficacy. Contact of the solution with polyvinylchloride bags should be avoided.

The product is compatible with glass infusion sets and with rigid infusion packs made of polyethylene; it may also be infused slowly using a syringe pump with a glass or plastic syringe.

6.3 Shelf Life

Unopened ampoules: 3 years

Unopened vials: 2 years

Opened ampoules or vials:

The product should be used immediately after opening the container.

Any unused solution from opened containers should be discarded.

Prepared infusion solutions:

Chemical and physical in-use stability has been demonstrated in glucose solution 5 % and sodium chloride solution 0.9 % for 24 hours at room temperature.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special Precautions For Storage

Keep the container in the outer carton.

Do not store above 25°C.

6.5 Nature And Contents Of Container

5 ml, 10 ml or 25 ml ampoules, made of colourless glass, type I.

50 ml vial, made of colourless glass, type I, rubber stopper.

Box of 10 ampoules with 5 ml

Box of 10 ampoules with 10 ml

Box of 10 ampoules with 25 ml

Box of 1 vial with 50 ml

Box of 10 vials with 50 ml

Box of 25 vials with 50 ml

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Glyceryl Trinitrate need not be diluted before use but can be diluted by 1:10 up to 1:40 with 5 % glucose solution, 5 % glucose solution and 0.9 % sodium chloride solution, or with 0.9 % sodium chloride solution.

The solution, whether or not diluted, should be infused slowly and not given by bolus injection. To ensure a constant infusion rate of glyceryl trinitrate it is recommended that Glyceryl Trinitrate be administered by means of a syringe pump or polyethylene infusion bag with a counter, or with a glass or rigid polyethylene syringe and polyethylene tubing. Systems made of polyvinyl chloride (PVC) may absorb up to 50% of the glyceryl trinitrate from the solution.

Vials of 50 ml Glyceryl Trinitrate are for single use only and should not be regarded as multi-dose containers.

7. Marketing Authorisation Holder

hameln pharma plus gmbh

Langes Feld 13

31789 Hameln

Germany

8. Marketing Authorisation Number(S)

PL 25215/0011

9. Date Of First Authorisation/Renewal Of The Authorisation

04/09/2008

10. Date Of Revision Of The Text

04/06/2009

Prescription-only medicine


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Nitrocine


1. Name Of The Medicinal Product

Nitrocine 1mg/ml, solution for infusion

2. Qualitative And Quantitative Composition

Ampoules containing 10 mg glyceryl trinitrate in 10 ml, or as glass bottles containing 50 mg glyceryl trinitrate in 50 ml.

For excipients see 6.1.

3. Pharmaceutical Form

Isotonic sterile solution for infusion

4. Clinical Particulars 4.1 Therapeutic Indications

Surgery:

Nitrocine is indicated for:

1. the rapid control of hypertension during cardiac surgery.

2. reducing blood pressure and maintaining controlled hypotension during surgical procedures.

3. controlling myocardial ischaemia during and after cardiovascular surgery.

Unresponsive congestive heart failure:

Nitrocine may be used to treat unresponsive congestive heart failure secondary to acute myocardial infarction.

Unstable angina:

Nitrocine may be used to treat unstable angina, which is refractory to treatment with beta blockers and sublingual nitrates.

4.2 Posology And Method Of Administration

Adults and Elderly

The dose of Nitrocine should be adjusted to meet the individual needs of the patient.

The recommended dosage range is 10 - 200 mcg/min but up to 400 mcg/min may be necessary during some surgical procedures.

Children:

The safety and efficacy of Nitrocine has not yet been established in children.

Surgery:

A starting dose of 25 mcg/min is recommended for the control of hypertension, or to produce hypotension during surgery. This may be increased by increments of 25 mcg/min at 5 minute intervals until the blood pressure is stabilized. Doses between 10 - 200 mcg/min are usually sufficient during surgery, although doses of up to 400 mcg/min have been required in some cases.

The treatment of perioperative myocardial ischaemia may be started with a dose of 15 - 20 mcg/min, with subsequent increments of 10 - 15 mcg/min until the required effect is obtained.

Unresponsive congestive heart failure:

The recommended starting dose is 20 - 25 mcg/min. This may be decreased to 10 mcg/min, or increased in steps of 20-25 mcg/min every 15 - 30 minutes until the desired effect is obtained.

Unstable angina:

An initial dose of 10 mcg/min is recommended with increments of 10mcg/min being made at approximately 30 minute intervals according to the needs of the patient.

Administration

Nitrocine can be administered undiluted by slow intravenous infusion using a syringe pump incorporating a glass or rigid plastic syringe.

Alternatively, Nitrocine may be administered intravenously as an admixture using a suitable vehicle such as Sodium Chloride Injection B.P. or Dextrose Injection B.P.

Prepared admixtures should be given by intravenous infusion or with the aid of a syringe pump to ensure a constant rate of infusion.

During Nitrocine administration there should be close haemodynamic monitoring of the patient.

Example of admixture preparation

To obtain an admixture of GTN at a concentration of 100 mcg/ml, add 50 ml Nitrocine solution (containing 50 mg glyceryl trinitrate) to 450 ml of infusion vehicle to give a final volume of 500 ml.

A dosage of 100 mcg/min. can be obtained by giving 60 ml of the admixture per hour. This is equivalent to a drip rate of 60 paediatric microdrops per minute or 20 standard drops per minute. At this drip rate the admixture provides enough solution for an infusion time of 8 hours 20 minutes.

For full details it is advisable to consult the dosage chart on the package insert.

Bottles of Nitrocine are for single use only and should not be regarded as multi-dose containers.

4.3 Contraindications

Nitrocine should not be used in the following cases:

Known hypersensitivity to nitrates, marked anaemia, severe cerebral haemorrhage, head trauma, uncorrected hypovolaemia or severe hypotension.

As the safety of Nitrocine during pregnancy and lactation has not yet been established, it should not be used unless considered absolutely essential.

Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.

4.4 Special Warnings And Precautions For Use

Close attention to pulse and blood pressure is necessary during the administration of Nitrocine infusions.

Nitrocine should be used with caution in patients suffering from hypothyroidism, severe liver or renal disease, hypothermia and malnutrition.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concurrent intake of drugs with blood pressure lowering properties e.g. beta blockers, calcium antagonists, vasodilators etc. and/or alcohol may potentiate the hypotensive effect of Nitrocine. The hypotensive effect of nitrates are potentiated by concurrent administration of sildenafil (Viagra®). This might also occur with neuroleptics and tricyclic antidepressants.

4.6 Pregnancy And Lactation

There is no, or inadequate, evidence of safety of the drug in human pregnancy or lactation, but it has been in widespread use for many years without apparent ill consequence, animal studies having shown no hazard. If drug therapy is needed in pregnancy, this product can be used if there is no safer alternative.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

In common with other nitrates, headaches and nausea may occur during administration. Other possible adverse reactions include hypotension, tachycardia, retching, diaphoresis, apprehension, restlessness, muscle twitching, retrosternal discomfort, palpitations, dizziness and abdominal pain. Paradoxical bradycardia has also been observed.

4.9 Overdose

Mild overdose usually results in hypotension and tachycardia. If arterial systolic blood pressure drops below 90 mmHg and if heart rate increases 10% above its initial value, the infusion should be discontinued to allow a return to pre-treatment levels. If hypotension persists, or in more severe cases, this may be reversed by elevating the legs and/or treatment with hypertensive agents.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: C01DA 02 – Organic Nitrates

Glyceryl trinitrate reduces the tone of vascular smooth muscle. This action is more marked on the venous capacitance vessels than the arterial vessels. There is a reduction in venous return to the heart and a lowering of elevated filling pressure. This lowering of filling pressure reduces the left ventricular end diastolic volume and preload. The net effect is a lowering of myocardial oxygen consumption.

Systemic vascular resistance, pulmonary vascular pressure and arterial pressure are also reduced by glyceryl trinitrate and there is a net reduction in the afterload.

By reducing the preload and afterload, glyceryl trinitrate reduces the workload on the heart.

Glyceryl trinitrate affects oxygen supply by redistributing blood flow along collateral channels from the epicardial to endocardial regions.

5.2 Pharmacokinetic Properties

As with all commonly used organic nitrates the metabolic degradation of glyceryl trinitrate occurs via denitration and glucuronidation. The less active metabolites resulting from this biotransformation can be recovered from the urine within 24 hours.

Glyceryl trinitrate is eliminated from plasma with a short half-life of about 2-3 minutes. This rapid disappearance from plasma is consistent with the high systemic clearance values for this drug (up to 3270 L/hour)

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glucose

Propylene glycol

Water for injection.

Hydrochloric acid (for pH adjustment)

6.2 Incompatibilities

Nitrocine contains glyceryl trinitrate in isotonic sterile solution and is compatible with commonly employed infusion solutions. No incompatibilities have so far been demonstrated.

Nitrocine is compatible with glass infusion bottles and with rigid infusion packs made of polyethylene. Nitrocine may also be infused slowly using a syringe pump with a glass or plastic syringe.

Nitrocine is incompatible with polyvinylchloride (PVC) and severe losses of glyceryl trinitrate (over 40%) may occur if this material is used. Contact with polyvinylchloride bags should be avoided. Polyurethane also induces a loss of the active ingredient.

6.3 Shelf Life

Glass ampoules 5 years

Glass vials 5 years

For admixture shelf life, refer to section 6.4.

6.4 Special Precautions For Storage

Chemical and physical in-use stability of the admixture has been demonstrated for 24 hours at 25?C in suitable containers.

From a microbiological point of view, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8?C, unless dilution has taken place in controlled and validated aseptic conditions.

6.5 Nature And Contents Of Container

Glass ampoules 10 ml (Type I glass)

Glass, rubber stoppered vials 50 ml (Type II glass)

6.6 Special Precautions For Disposal And Other Handling

Bottles of Nitrocine are for single use only and should not be regarded as multi-dose containers.

Admixtures are prepared by replacing a given volume of infusion vehicle with an equal volume of the product to produce the final infusion solution. For admixture storage, refer to section 6.4.

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

United Kingdom

8. Marketing Authorisation Number(S)

PL 00039/0747

9. Date Of First Authorisation/Renewal Of The Authorisation

21 January 2009

10. Date Of Revision Of The Text
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Carnitor 1 g Solution for Injection


1. Name Of The Medicinal Product

Carnitor 1 g Solution for Injection

2. Qualitative And Quantitative Composition

L-carnitine inner salt 1 g

3. Pharmaceutical Form

A clear, colourless or light straw- coloured solution

4. Clinical Particulars 4.1 Therapeutic Indications

Indicated for the treatment of primary and secondary carnitine deficiency in adults, children, infants and neonates.

Secondary carnitine deficiency in haemodialysis patients.

Secondary carnitine deficiency should be suspected in long-term haemodialysis patients who have the following conditions:

1. Severe and persistent muscle cramps and/or hypotensive episodes during dialysis.

2. Lack of energy causing a significant negative effect on the quality of life.

3. Skeletal muscle weakness and/or myopathy.

4. Cardiomyopathy.

5. Anaemia of uraemia unresponsive to or requiring large doses of erythropoietin.

6. Muscle mass loss caused by malnutrition.

4.2 Posology And Method Of Administration

For slow intravenous administration over 2-3 minutes

Adults, Children, infants and neonates

It is advisable to monitor therapy by measuring free and acyl carnitine levels in both plasma and urine.

The management of inborn errors of metabolism:

The dosage required depends upon the specific inborn error of metabolism concerned and the severity of presentation at the time of treatment. However, the following can be considered as a general guide.

In acute decompensation, dosages of up to 100 mg/kg/day in 3-4 divided doses are recommended. Higher doses have been used although an increase in adverse events, primarily diarrhoea, may occur.

Secondary carnitine deficiency in haemodialysis patients:

It is strongly recommended that, before initiating therapy with Carnitor, plasma carnitine is measured. Secondary carnitine deficiency is suggested by a plasma ratio of acyl to free carnitine of greater than 0.4 and/or when free carnitine concentrations are lower than 20 ?mol/litre.

A dose of 20mg per kg should be administered as an intravenous bolus at the end of each dialysis session (assuming three sessions per week). The duration of intravenous treatment should be at least three months, which is the time usually required to restore normal muscle levels of free carnitine. The overall response should be assessed by monitoring plasma acyl to free carnitine levels and by evaluating the patient's symptoms. When carnitine supplementation has been stopped there will be a progressive decline in carnitine levels. The need for a repeat course of therapy can be assessed by plasma carnitine assays at regular intervals and by monitoring the patient's symptoms.

Haemodialysis - maintenance therapy:

If significant clinical benefit has been gained by the first course of intravenous Carnitor then maintenance therapy can be considered using 1 g per day of Carnitor orally. On the day of the dialysis, oral Carnitor has to be administered at the end of the session.

4.3 Contraindications

Hypersensitivity to any of the constituents of the product.

4.4 Special Warnings And Precautions For Use

While improving glucose utilisation, the administration of L-carnitine to diabetic patients receiving either insulin or hypoglycaemic oral treatment may result in hypoglycaemia. Plasma glucose levels in these subjects must be monitored regularly in order to adjust the hypoglycaemic treatment immediately, if required.

The safety and efficacy of oral L-carnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral L-carnitine in patients with severely compromised renal function or in end stage renal disease (ESRD) patients on dialysis may result in an accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are usually excreted in the urine. This situation has not been observed following intravenous administration of L-carnitine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known interactions.

4.6 Pregnancy And Lactation

Reproductive studies were performed in rats and rabbits. There was no evidence of a teratogenic effect in either species. In the rabbit but not in the rat, there was a statistically insignificant greater number of post implantation losses at the highest dose tested (600 mg/kg daily) as compared with control animals. The significance of these findings for man is unknown. There is no experience of use in pregnant patients with primary systemic carnitine deficiency.

Taking into account the serious consequences to a pregnant woman who has primary systemic carnitine deficiency stopping treatment, the risk to the mother of discontinuing treatment seems greater than the theoretical risk to the foetus if treatment is continued.

Levocarnitine is a normal component of human milk. Use of levocarnitine supplementation in nursing mothers has not been studied.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Various mild gastro-intestinal complaints have been reported during the long-term administration of oral levocarnitine, these include transient nausea and vomiting, abdominal cramps and diarrhoea.

Decreasing the dosage often diminishes or eliminates drug-related patient body odour or gastro-intestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration and after any dosage increase.

4.9 Overdose

There have been no reports of toxicity from levocarnitine overdosage. Overdosage should be treated with supportive care.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: A16AA01 (Amino acids and derivatives)

L-Carnitine is present as a natural constituent in animal tissues, micro-organisms and plants. In man the physiological metabolic requirements are met both by the consumption of food containing carnitine and the endogenous synthesis in the liver and kidneys from lysine with methionine serving as the methyl donor. Only the L-isomer is biologically active, playing an essential role in lipid metabolism as well as in the metabolism of ketone bodies as branched chain-amino-acids. L-Carnitine as a factor is necessary in the transport of long-chain fatty acids into the mitochondria – facilitating the oxidation of fatty acids rather than their incorporation into triglycerides. By releasing CoA from its thioesters, through the action of CoA; carnitine acetyl transferase, L-carnitine also enhances the metabolic flux in the Kreb's cycle; with the same mechanism it stimulates the activity of pyruvate dehydrogenase and in skeletal muscle, the oxidation of branched chain-amino acids. L-Carnitine is thus involved, directly or indirectly in several pathways so that its availability should be an important factor controlling not only the oxidative utilisation of fatty acids and ketone bodies but also that of glucose and some amino acids.

5.2 Pharmacokinetic Properties

The absorbed L-carnitine is transported to various organ systems via the blood. The presence of membrane-bound proteins in several tissues including red blood cells that bind carnitine, suggest that a transport system in the blood and a cellular system for the collective uptake is present in several tissues. Tissue and serum carnitine concentration depends on several metabolic processes, carnitine biosynthesis and dietary contributions, transport into and out of tissues, degradation and excretion may all affect tissue carnitine concentrations.

Absorption

L-Carnitine is absorbed by the mucosal cells of the small intestine and enters the blood stream relatively slowly; the absorption is probably associated with an active transluminal mechanism.

The apparent systemic availability after oral administration is limited (<10%) and variable.

Distribution

Absorbed L-carnitine is transported to various organ systems via the blood; it is thought that a transport system in the blood and a cellular system for selective uptake is involved.

Excretion

L-Carnitine is excreted mainly in the urine and is variable. The excretion is directly proportional to the blood levels.

Metabolism

L-Carnitine is metabolised to a very limited extent.

5.3 Preclinical Safety Data

L-Carnitine is a naturally occurring body substance in human beings, plants and animals. Carnitor products are used to bring the level of L-carnitine in the body up to those found naturally. Appropriate pre-clinical studies have been undertaken and show no signs of toxicity at normal therapeutic doses.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Hydrochloric acid 10%

Water for injection

6.2 Incompatibilities

None known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Store below 25oC.

Store in the original carton in order to protect from light.

6.5 Nature And Contents Of Container

Ph.Eur. Type 1 clear glass ampoules of 5 ml capacity.

The ampoules are packed in cardboard outer cartons containing 5 ampoules.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Sigma-Tau Industrie Farmaceutiche Riunite SpA,

Viale Shakespeare 47-00144,

Rome, Italy.

8. Marketing Authorisation Number(S)

PL 08381/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

30 November 1999

10. Date Of Revision Of The Text

November 2008


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