sucrose in warfarin
 

Pills
 

ED Pills

ED Drugs
 

Boots Catarrh Pastilles


Boots Catarrh Pastilles

(Eucalyptus Oil, Menthol, Pumilio Pine Oil)

relieves catarrh, coughs and colds

45 g

Read all of this carton for full instructions.

What this medicine is for

This medicine contains menthol, eucalyptus and pumilio oils, which relieve chesty coughs and have antiseptic properties. It can be used to relieve the symptoms of congestion caused by catarrh, coughs and colds.

Before you take this medicine Do not take: If you are allergic to any of the ingredients If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains glucose and sucrose) Talk to your pharmacist or doctor: If you are pregnant or breastfeeding

Information about some of the ingredients: Each pastille contains a total of 0.8 g of glucose and sucrose. This should be taken into account by people with diabetes. The colour E122 in this medicine may cause allergic reactions.

How to take this medicine

Check the inner bag is not broken before use. If it is, do not use the pastilles.

Adults and children of 12 years and over: Suck one pastille when you need to.

Don’t take more than 20 pastilles in 24 hours.

Suck each pastille slowly until it dissolves.

Do not give to children under 12 years.

Do not take more than the amount recommended.

If symptoms do not go away, talk to your doctor.

If you take too many pastilles: Talk to a pharmacist or doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the pastilles. See a doctor at once:

Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

Each pastille contains Eucalyptus Oil 0.02% v/w, Menthol 0.8% w/w, Pumilio Pine Oil 0.6% v/w.

Also contains: modified starch, sucrose, glucose syrup, marshmallow liquid extract, vegetable oil, beeswax, water, thymol, carmoisine (E122).

PL 00094/0009

Text prepared 8/09

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by The Marketing Authorisation holder

Ernest Jackson and Co Crediton Devon EX17 3AP

If you need more advice ask your pharmacist.


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Boots Cystitis Relief (Cranberry Flavour)


Boots Cystitis Relief

(Sodium Citrate)

Cranberry flavour

48 hour complete course

6 sachets

Read all of this carton for full instructions.

What this medicine is for

This medicine contains Sodium Citrate which relieves the symptoms of cystitis in women by making the urine less acidic.

Before you take this medicine Do not take: If you are allergic to any of the ingredients If you have diabetes, heart disease, high blood pressure If you have kidney disease or have had it If you are on a low salt (sodium) diet (each sachet contains 939 mg of sodium) If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose) If you are pregnant or breastfeeding How to take this medicine

Check the sachet is not broken before use. If it is, do not take that sachet.

Dissolve the contents of the sachet in a glass of water and drink the solution.

Adult women: Take one sachet dissolved in water, three times a day for 2 days.

Men and children: Not recommended.

You should complete the 2 day course of 6 sachets.

Do not take more than the amount recommended above.

If symptoms do not go away within 2 days talk to your doctor.

If you take too many sachets: Talk to a doctor.

Possible side effects

This medicine is not expected to cause side effects.

If you notice any side effect please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Store in a dry place.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

Each sachet of granules contains Sodium Citrate Dihydrate 4 g.

Also contains: sucrose, colloidal silicon dioxide, saccharin sodium, cranberry flavour.

PL 12063/0045

Text prepared 9/07

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by the Marketing Authorisation holder

Wrafton Laboratories Limited Braunton Devon EX33 2DL

If you need more advice ask your pharmacist.

3423aeMC


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Boots Cold and Flu Max Relief Sachets Lemon Flavour


Boots Cold and Flu Max Relief Sachets Lemon Flavour

(Paracetamol, Phenylephrine Hydrochloride)

Please read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice What this medicine is for

This medicine contains paracetamol, an analgesic which relieves pain and reduces fever, and phenylephrine, a decongestant to relieve a blocked up nose. It can be used to relieve the symptoms of colds and flu including aches and pains, sore throat, headache, blocked nose and fever.

Before you take this medicine

This medicine can be taken by adults and children of 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take: If you are allergic to any of the ingredients If you have heart or blood vessel disease If you have high blood pressure (including that due to a tumour near your kidney) If you have diabetes, glaucoma or an overactive thyroid If you are taking monoamine oxidase inhibitors (for depression) or have taken them within the last 14 days If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose) If you are a man with prostate problems If you are pregnant or breastfeeding, unless your doctor tells you to Talk to your pharmacist or doctor: If you have severe kidney or liver problems (including alcoholic liver disease) If you have been told that you have Raynaud’s Phenomenon, a condition caused by poor circulation in the fingers and toes If you are on a controlled sodium diet (each sachet contains 118 mg sodium) Other important information

Do not drink alcohol (e.g. wine, beer, spirits) whilst taking this medicine.

Information about some of the ingredients in this medicine: Aspartame (E951) contains a source of phenylalanine equivalent to 14 mg per sachet. May be harmful for people with phenylketonuria.

This medicine contains 1.9 g of sucrose per sachet. This should be taken into account if you suffer from diabetes.

If you take other medicines

This medicine contains paracetamol. Do not take with any other paracetamol-containing products.

Before you take these sachets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

Barbiturates (for epilepsy), tricyclic antidepressants Colestyramine (to reduce blood fat levels) Metoclopramide or domperidone (for feeling sick or being sick) Warfarin or other blood thinners - If you take warfarin you can take occasional doses of this medicine, but talk to your doctor first before you take it on a regular basis Other decongestants Medicines for high blood pressure, heart or circulatory problems (e.g. atenolol, hydralazine or digoxin)

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the sachet is not broken before use. If it is, do not take that sachet.

Dissolve the contents of the sachet in a mug of hot, but not boiling, water and drink.

Adults and children of 12 years and over: Take one sachet every 4 to 6 hours, if you need to. Don't take more than 4 sachets in 24 hours.

Do not give to children under 12 years.

Do not take more than the amount recommended.

Do not take for more than 7 days, unless your doctor tells you to.

If symptoms do not go away talk to your doctor.

If you take too many sachets: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the sachets. See a doctor at once: Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions) These other effects are less serious. If they bother you talk to a pharmacist: Skin rash Difficulty sleeping, restlessness, tremor, anxiety, hallucinations Fast or slow heart beat, high blood pressure Difficulty in passing urine Unusual bruising or infections such as sore throats - this may be a sign of very rare changes in the blood

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25?C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each sachet contains Paracetamol 1000 mg, Phenylephrine Hydrochloride 12.2 mg, which are the active ingredients.

As well as the active ingredients, the sachets also contain sucrose, sodium citrate, citric acid, ascorbic acid, acesulfame potassium (E950), aspartame (E951), quinoline yellow (E104), lemon flavours.

This pack contains 10 sachets of yellow powder for oral suspension.

Who makes this medicine

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by the Marketing Authorisation holder

Wrafton Laboratories Limited Braunton Devon EX33 2DL

Leaflet prepared October 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA
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Heart and Circulation Tonic


Generic Name: crataegus fruit, arnica montana, potassium phosphate, dibasic and calcium fluoride granule
Dosage Form: FOR ANIMAL USE ONLY
HEART AND CIRCULATION TONIC

Improves circulation and strengthens heart and arteries

Indications: Homeopathic heart and circulation tonic.

Dosage: Sprinkle into the mouth and administer 3 times daily.  Cats and dogs under 20 lbs: 1 large pinch.  Dogs 20-50 lbs: 2 pinches.  Dogs over 50 lbs: 1/4 cap.

Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Crataegus (3X) (HPUS), Arnica (3X) (HPUS), Kali phos (6C) (HPUS), Calc flour (6C) (HPUS)

Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd. 

Suite 160

Boca Raton, FL 33487

Phone: +1.877.289.1235

International: +1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Keep this and all medicines from the reach of children.


HEART AND CIRCULATION TONIC 
crataegus, arnica , kali phos, calc flour   granule Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-156 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CRATAEGUS FRUIT (CRATAEGUS FRUIT) CRATAEGUS FRUIT 3 [hp_X]  in 50 mg ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 3 [hp_X]  in 50 mg POTASSIUM PHOSPHATE, DIBASIC (POTASSIUM CATION) POTASSIUM PHOSPHATE, DIBASIC 6 [hp_C]  in 50 mg CALCIUM FLUORIDE (CALCIUM CATION) CALCIUM FLUORIDE 6 [hp_C]  in 50 mg Inactive Ingredients Ingredient Name Strength SUCROSE 20000 mg  in 20000 mg Product Characteristics Color white (white sucrose granules) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68647-156-10 20000 mg In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2010
Labeler - Feelgood Health (538418296) Establishment Name Address ID/FEI Operations W. Last 567284153 manufacture Revised: 09/2010Feelgood Health

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Thyroid Soothe


Generic Name: matricaria recutita, lycopus virginicus, cardamom, crataegus fruit and strychnos nux-vomica seed granule
Dosage Form: FOR ANIMAL USE ONLY
Thyroid Soothe

Soothes the thyroid, heart  and endocrine systems

Indications: Homeopathic remedy soothes the thyroid, heart and endocrine system.

Dosage: Sprinkle granules directly into the mouth and hold closed briefly. Initial dose: every 30 minutes for up to 10 doses. Thereafter, 3 times daily. Cats and dogs under 20 lbs: 1 large pinch. Dogs 20-50 lbs: 2 pinches. Dogs over 50 lbs: ?  cap granules. May be used with Heart and Circulation Tonic™.

Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Chamomilla (30C) (HPUS), Lycopus (6C) (HPUS), Zingiber (3X) (HPUS), Cratageous (30C) (HPUS), Nux vom (30C) (HPUS)

Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd. 

Suite 160

Boca Raton, FL 33487

Phone: +1.877.289.1235

International: +1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Keep this and all medicines from the reach of children.


Thyroid Soothe 
chamomilla, lycopus, zingiber, cratageous, nux vom  granule Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-185 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA 30 [hp_C]  in 40 mg LYCOPUS VIRGINICUS (LYCOPUS VIRGINICUS) LYCOPUS VIRGINICUS 6 [hp_C]  in 40 mg CARDAMOM (CARDAMOM) CARDAMOM 3 [hp_X]  in 40 mg CRATAEGUS FRUIT (CRATAEGUS FRUIT) CRATAEGUS FRUIT 30 [hp_C]  in 40 mg STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 30 [hp_C]  in 40 mg Inactive Ingredients Ingredient Name Strength SUCROSE 20000 mg  in 20000 mg Product Characteristics Color white (white sucrose granules) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68647-185-10 20000 mg In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2010
Labeler - Feelgood Health (538418296) Establishment Name Address ID/FEI Operations W. Last 567284153 manufacture Revised: 09/2010Feelgood Health

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Allergy Itch Ease


Generic Name: arisaema triphyllum root, viola tricolor, comocladia dentata bark/leaf, chamomile and artemisia cina flower granule
Dosage Form: FOR ANIMAL USE ONLY
Allergy Itch Ease

Relieves skin itch

Indications: Homeopathic remedy for the relief of itchy skin in pets.

Dosage: Sprinkle granules directly into the mouth and hold closed briefly.Initial dose: every 30 minutes for up to 10 doses. Thereafter, 3 times daily. Cats and dogs under 20 lbs: 1 large pinch. Dogs 20-50 lbs: 2 pinches. Dogs over 50 lbs: 1/4 cap granules. May be used with Skin and Coat Tonic™ .

Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Arum triph (6C) (HPUS), Viola tri. (6C) (HPUS), Comocladia (6C) (HPUS), Chamomilla (12C) (HPUS), Cina (6C) (HPUS)

Sucrose (inactive ingredient)

Enter section text here

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, FL 33487

Phone: 1.877.289.1235

International: + 1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.


Allergy Itch Ease 
arum triph, viola tri. , comocladia, chamomilla, cina   granule Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-183 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARISAEMA TRIPHYLLUM ROOT (ARISAEMA TRIPHYLLUM ROOT) ARISAEMA TRIPHYLLUM ROOT 6 [hp_C]  in 40 mg VIOLA TRICOLOR (VIOLA TRICOLOR) VIOLA TRICOLOR 6 [hp_C]  in 40 mg COMOCLADIA DENTATA BARK/LEAF (COMOCLADIA DENTATA BARK/LEAF) COMOCLADIA DENTATA BARK/LEAF 6 [hp_C]  in 40 mg CHAMOMILE (CHAMOMILE) CHAMOMILE 12 [hp_C]  in 40 mg ARTEMISIA CINA FLOWER (ARTEMISIA CINA FLOWER) ARTEMISIA CINA FLOWER 6 [hp_C]  in 40 mg Inactive Ingredients Ingredient Name Strength SUCROSE   Product Characteristics Color white (white sucrose granules) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68647-183-10 20000 mg In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2010
Labeler - Feelgood Health (538418296) Establishment Name Address ID/FEI Operations W. Last 567284153 manufacture Revised: 08/2010Feelgood Health

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TF Defense


Generic Name: silybum marianum seed, crotalus horridus horridus venom, artemisia cina flower, aconitum napellus and ferrum phosphoricum granule
Dosage Form: FOR ANIMAL USE ONLY
TF Defense

Boosts red blood cells and the immune system

Indications: Homeopathic remedy to boost red blood cells and immune function.

Dosage: Initial dose: Administer every hour for up to 10 doses. Thereafter 3 times daily for approximately 7-10 days. Cats and dogs under 20 lbs: Large pinch of granules sprinkled into the mouth. Dogs 20-50 lbs: 2 pinches sprinkled into the mouth. Dogs over 50 lbs:1/4 cap of granules sprinkled into the mouth.

Caution: Recommended for use under veterinary supervision. Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Carduus mar (3X) (HPUS), Crotalus hor (200C) (HPUS), Cina (6C) (HPUS), Aconitum nap (6C) (HPUS), Ferrum phos (6C) (HPUS)

Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, FL 33487

Phone: 1.877.289.1235

International: + 1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Keep this and all medicines from the reach of children.


TF Defense 
carduus mar, crotalus hor, cina , aconitum nap, ferrum phos   granule Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-151 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILYBUM MARIANUM SEED (SILYBUM MARIANUM SEED) SILYBUM MARIANUM SEED 3 [hp_X]  in 40 mg CROTALUS HORRIDUS HORRIDUS VENOM (CROTALUS HORRIDUS HORRIDUS VENOM) CROTALUS HORRIDUS HORRIDUS VENOM 200 [hp_C]  in 40 mg ARTEMISIA CINA FLOWER (ARTEMISIA CINA FLOWER) ARTEMISIA CINA FLOWER 6 [hp_C]  in 40 mg ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 6 [hp_C]  in 40 mg FERRUM PHOSPHORICUM (FERRUM PHOSPHORICUM) FERRUM PHOSPHORICUM 6 [hp_C]  in 40 mg Inactive Ingredients Ingredient Name Strength SUCROSE 20000 mg  in 20000 mg Product Characteristics Color white (white sucrose granules) Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68647-151-10 20000 mg In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2010
Labeler - Feelgood Health (538418296) Establishment Name Address ID/FEI Operations W.Last 567284153 manufacture Revised: 09/2010Feelgood Health

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Boots Effervescent Health Salts


Boots Effervescent Health Salts

(Magnesium Sulphate, Sodium Bicarbonate, Citric acid)

Sparkling relief of upset stomach, heartburn, indigestion and occasional constipation

227 g

Read all of this label for full instructions.

Uses: An antacid and laxative for the relief of upset stomach, heartburn, indigestion, feeling sick and for the relief of occasional constipation.

Before you take this medicine Do not take: If you are allergic to any of the ingredients If you have severe stomach problems If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose) Talk to your pharmacist or doctor: If you have heart, kidney or liver problems If you have diabetes If you need to use a laxative every day If you have severe stomach pain If you are elderly, or feel very weak If you are on a controlled sodium diet (each level teaspoon of powder contains 185 mg sodium) If you are pregnant or breastfeeding How to take this medicine

Check the inner seal is not broken before first use. If it is, do not use the powder.

Use a dry spoon to measure. Mix the amount in the table with a glass of water and drink the solution, before it stops fizzing. Replace lid firmly after use.

Adults:

For upset stomach, heartburn, indigestion, feeling sick: One or two teaspoonfuls.

For constipation: Two teaspoonfuls before breakfast or at bedtime.

Children of 3 years and over: Reduce the amount above according to size and age.

Do not give to children under 3 years.

Do not take this medicine for long periods of time (generally more than a week).

Do not take more than the amount recommended.

If symptoms worsen talk to your doctor. If symptoms don’t go away talk to your doctor.

Possible side effects

Most people will not have problems, but some may get some of these:

Gripping pain in your stomach Diarrhoea, feeling sick, being sick

If you have taken the medicine for a long time you may get:

Light headedness, confusion Muscle weakness, cramps Numbness, tingling, breathing problems

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Store in a dry place below 25°C and away from strong smells.

Keep all medicines out of the sight and reach of children.

Use by the date on the base of the tub. Throw away any powder left 3 months after opening.

Active ingredients: This effervescent powder contains Citric Acid 19.5% w/w, Magnesium Sulphate 17.4% w/w, Sodium Bicarbonate 22.6% w/w.

Also contains: sucrose.

PL12063/0039

Text prepared 4/08

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

by the MA holder

Wrafton Laboratories Limited Braunton Devon EX33 2DL

If you need more advice ask your pharmacist.


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Jantoven


In the US, Jantoven (warfarin systemic) is a member of the drug class coumarins and indandiones and is used to treat Antiphospholipid Syndrome, Chronic Central Venous Catheterization, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis - First Event, Deep Vein Thrombosis - Recurrent Event, Heart Attack, Heart Failure, Prevention of Thromboembolism in Atrial Fibrillation, Prosthetic Heart Valves, Prosthetic Heart Valves - Mechanical Valves, Prosthetic Heart Valves - Tissue Valves, Protein S Deficiency, Pulmonary Embolism - First Event, Pulmonary Embolism - Recurrent Event and Thromboembolic Stroke Prophylaxis.

US matches:

Jantoven Ingredient matches for Jantoven Warfarin

Warfarin sodium salt (a derivative of Warfarin) is reported as an ingredient of Jantoven in the following countries:

United States

International Drug Name Search


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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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Uti-Free


Generic Name: berberis vulgaris fruit, lytta vesicatoria and delphinium staphisagria seed granule
Dosage Form: FOR ANIMAL USE ONLY
Uti-Free

Reduces frequent and painful urination

Indications: Homeopathic remedy for common bladder and urinary tract problems in pets.

Dosage:Initial Dose: Administer every 30 min for up to 6 doses. Thereafter 2-3 times daily for at least 7 days.  Maintenance dose: 2 doses of PetAlive Uti-Free™ daily. Cats and dogs under 20 lbs: Large pinch of granules sprinkled into mouth. Dogs 20-50 lbs: 2 pinches sprinkled into mouth.  Dogs over 50 lbs: 1/4 cap of granules sprinkled into mouth

Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Berberis vulg (3X) (HPUS), Cantharis (6C) (HPUS), Staphysagris (6C) (HPUS)

Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd. 

Suite 160

Boca Raton, FL 33487

Phone: +1.877.289.1235

International: +1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.


Uti-Free 
berberis vulg,cantharis,staphysag  granule Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-145 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BERBERIS VULGARIS FRUIT (BERBERIS VULGARIS FRUIT) BERBERIS VULGARIS FRUIT 3 [hp_X]  in 66.67 mg LYTTA VESICATORIA (LYTTA VESICATORIA) LYTTA VESICATORIA 6 [hp_C]  in 66.67 mg DELPHINIUM STAPHISAGRIA SEED (DELPHINIUM STAPHISAGRIA SEED) DELPHINIUM STAPHISAGRIA SEED 6 [hp_C]  in 66.67 mg Inactive Ingredients Ingredient Name Strength SUCROSE 1   in 17000 mg Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68647-145-10 20000 mg In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2010
Labeler - Feelgood Health (538418296) Establishment Name Address ID/FEI Operations W Last 567284153 manufacture Revised: 06/2010Feelgood Health

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Beechams Max Strength Sore Throat Relief Blackberry Lozenges


1. Name Of The Medicinal Product

Beechams Max Strength Sore Throat Relief Blackberry Lozenges.

2. Qualitative And Quantitative Composition

Hexylresorcinol 2.5mg and Benzalkonium Chloride Solution 1.2mg

3. Pharmaceutical Form

Lozenge

4. Clinical Particulars 4.1 Therapeutic Indications

Symptomatic relief of sore throat, the associated pain and pharyngitis.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children over the age of 12: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 8 lozenges in 24 hours.

Children aged 7 to 12 years: One lozenge dissolved slowly in the mouth every three hours or as required. Do not take more than 4 lozenges in 24 hours. Not to be given to children under 7 years.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or excipients.

Patients with metabolic disorders relating to glucose/sucrose ingestion or fructose intolerance

4.4 Special Warnings And Precautions For Use

Keep out of the reach and sight of children

If symptoms persist consult your doctor.

Do not exceed the stated dose

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Contains 2.5 g of total glucose and sucrose per lozenge. This should be taken into account in patients with diabetes mellitus.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None

4.6 Pregnancy And Lactation

There is a lack of evidence of safety of the product in human pregnancy and in animals, but both hexylresorcinol and benzalkonium chloride have been used widely in lozenges for many years without apparent ill consequence. However, as with all medicines, caution should be exercised during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Gastrointestinal Disorders: Local irritations or inflammations in the mouth and throat.

4.9 Overdose

The oral toxic dose of benzalkonium chloride is between 1 and 3g, symptoms of overdose are unlikely with a product containing such a low level.

An overdose of hexylresorcinol may cause minor gastrointestinal irritation.

After withdrawal of the product, treatment is symptomatic.

Theoretically symptoms are possible in children if at least 50 lozenges are consumed in a short space of time. In such extreme overdose related to menthol ingestion, symptoms may include nausea, vomiting, diarrhoea, profuse sweating and intense thirst.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Hexylresorcinol is a local anaesthetic effective for topical use on the mucous membranes of the mouth and throat. Mild antiseptic activity has also been demonstrated.

Benzalkonium chloride is a quaternary ammonium compound with antiseptic activity typical of this group.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Citric acid monohydrate, sucrose, liquid glucose, propylene glycol, blackberry flavour, levomenthol, Ponceau Red E124, Brilliant Black E151

6.2 Incompatibilities

Benzalkonium chloride is incompatible with other anionic surfactants, citrates, iodides, nitrates, permanganates, salicylates, tartrates and alkalis. Incompatibilities have also been reported with other substances including aluminium, hydrogen peroxide, kaolin and some sulphonamides.

Hexylresorcinol is also incompatible with alkalis and oxidising agents.

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Blisters (PVC 250 microns/PVdC 60 microns/Aluminium 20 microns)

Pack sizes 10, 12, 20.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Beecham Group Plc

908 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, Middlesex, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0386

9. Date Of First Authorisation/Renewal Of The Authorisation

26 April 2002

10. Date Of Revision Of The Text

26/01/2011


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Equine Joint Relief


Generic Name: homeopathic remedy
Dosage Form: FOR ANIMAL USE ONLY
Equine Joint Relief

For stiff joints and sore muscles

Indications: Homeopathic remedy for the relief of stiff joints and sore muscles in horses.

Dosage: Sprinkle 1 capful of pilules directly into the mouth or offer on the hand. Initial dose: every 30 minutes for up to 10 doses. Thereafter, 3 times daily.

Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines out of reach of children.

Ingredients: Apis (6C) (HPUS), Rhus tox (30C) (HPUS), Ferrum phos (6X) (HPUS), Nat phos (6X) (HPUS), Arnica (6C) (HPUS), Calc fluor (6X) (HPUS)

Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, FL 33487

Phone: 1.877.289.1235

International: + 1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Keep this and all medicines out of reach of children.


Equine Joint Relief 
apis, rhus tox, ferrum phos , nat phos , arnica , calc fluor   granule Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-187 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 6 [hp_C]  in 33.3 mg TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 30 [hp_C]  in 33.3 mg FERRUM PHOSPHORICUM (FERRUM PHOSPHORICUM) FERRUM PHOSPHORICUM 6 [hp_X]  in 33.3 mg SODIUM PHOSPHATE, DIBASIC ANHYDROUS (SODIUM CATION) SODIUM PHOSPHATE, DIBASIC ANHYDROUS 6 [hp_X]  in 33.3 mg ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 6 [hp_C]  in 33.3 mg CALCIUM FLUORIDE (CALCIUM CATION) CALCIUM FLUORIDE 6 [hp_X]  in 33.3 mg Inactive Ingredients Ingredient Name Strength SUCROSE   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68647-187-10 200000 mg In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2010
Labeler - Feelgood Health (538418296) Establishment Name Address ID/FEI Operations W.Last 567284153 manufacture Revised: 09/2010Feelgood Health

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KC Defense


Generic Name: echinacea purpurea, plantago major, ferrum phosphoricum, potassium sulfate, magnesium phosphate, dibasic trihydrate and bryonia alba root granule
Dosage Form: FOR ANIMAL USE ONLY
KC Defense

Kennel Cough treatment and prevention

Indications: Homeopathic remedy for `kennel’ cough.

Dosage: Initial dose: Administer hourly for up to 10 doses.  Thereafter administer 3 times daily for 14-21 days.  Cats and dogs under 20 lbs: Large pinch of granules sprinkled into mouth.  Dogs 20-50 lbs: 2 pinches sprinkled into mouth.  Dogs over 50 lbs: 1/4 cap of granules sprinkled into mouth.

Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Echinacea purp (3X) (HPUS), Plantago (3X) (HPUS), Ferrum phos (6C) (HPUS), Kali sulph (6C) (HPUS), Mag phos (6C) (HPUS), Bryonia (6C) (HPUS)

Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd.

Suite 160

Boca Raton, FL 33487

Phone: 1.877.289.1235

International: + 1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.



KC Defense 
echinacea purp,plantago,ferrum phos,kali sulph,mag phos, bryonia  granule Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-135 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA PURPUREA (ECHINACEA PURPUREA) ECHINACEA PURPUREA 3 [hp_X]  in 33.33 mg PLANTAGO MAJOR (PLANTAGO MAJOR) PLANTAGO MAJOR 3 [hp_X]  in 33.33 mg FERRUM PHOSPHORICUM (FERRUM PHOSPHORICUM) FERRUM PHOSPHORICUM 6 [hp_C]  in 33.33 mg POTASSIUM SULFATE (POTASSIUM CATION) POTASSIUM SULFATE 6 [hp_C]  in 33.33 mg MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_C]  in 33.33 mg BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 6 [hp_C]  in 33.33 mg Inactive Ingredients Ingredient Name Strength SUCROSE 1   in 20000 mg Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68647-135-10 20000 mg In 1 BOTTLE, GLASS None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2010
Labeler - Feelgood Health (538418296) Establishment Name Address ID/FEI Operations W Last 567284153 manufacture Revised: 06/2010Feelgood Health

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Venofer


Generic Name: Iron Sucrose
Class: Iron Preparations
Chemical Name: iron saccharate
CAS Number: 8047-67-4

Introduction

Hematinic agent; a polynuclear iron (III)-hydroxide sucrose complex.

Uses for Venofer Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy

Treatment of iron deficiency anemia in hemodialysis patients receiving epoetin alfa therapy.1 2 3 4 5 6 9 11 12 National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF-DOQI) guidelines recommend regular use of IV iron to prevent functional (and absolute) iron deficiency and improve erythropoiesis in most hemodialysis patients receiving epoetin alfa therapy.6

Available data suggest that iron sucrose and sodium ferric gluconate may be associated less frequently with serious adverse effects (e.g., hypersensitivity reactions) than iron dextran.4 9 15 16

Venofer Dosage and Administration General

Goal of iron therapy in patients with chronic renal failure is to achieve and maintain a transferrin saturation (TSAT) of at least 20% and a serum ferritin concentration of at least 100 ng/mL.6

Monitor maintenance iron status by measuring TSAT and serum ferritin concentration every 3 months.6

Some clinicians have administered test doses in patients with history of allergic reactions to iron dextran.10 11 12 (See Sensitivity Reactions under Cautions.)

Iron sucrose should be administered by personnel trained to provide emergency treatment and who have immediate access to appropriate agents for the treatment of a severe allergic or anaphylactic reaction.6

Administration IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer (diluted) by IV infusion or (undiluted) by slow IV injection directly into the dialysis line.1

Administer 1–3 times weekly; do not administer more frequently.1

Any unused portion of the diluted or opened undiluted iron sucrose solution should be discarded.1

Dilution

When given by IV infusion, the contents of each 100-mg vial must be diluted immediately prior to use in a maximum of 100 mL of 0.9% sodium chloride injection.1

Rate of Administration

Slow IV injection: Administer undiluted drug at ?20 mg/minute to minimize risk of hypotension.1 3 (See Cardiovascular Effects under Cautions.)

IV infusion: Administer diluted drug over a period of at least 15 minutes.1

Dosage

Dosage expressed in terms of mg of elemental iron.1 Iron sucrose injection contains the equivalent of 20 mg of elemental iron per mL.1

Adults Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy IV

Test dose (given according to clinician discretion): Generally 50 mg of iron sucrose diluted in 50 mL of 0.9% sodium chloride injection and administered over 3–10 minutes;1 alternatively, 20–25 mg of iron sucrose diluted in 100 mL of 0.9% sodium chloride injection and administered over 30–60 minutes.10 11 12

Therapeutic dose: 100 mg 1–3 times weekly.1 Most patients require minimum cumulative dose of 1 g of elemental iron, administered over 10 sessions at or during sequential dialysis treatments, to achieve a favorable hemoglobin/hematocrit response.1 2 3 6

Courses of iron sucrose therapy may be repeated.1 6

Prescribing Limits Adults Iron Deficiency Anemia in Hemodialysis Patients Receiving Epoetin Alfa Therapy IV

Single doses generally should not exceed 100 mg and frequency of dosing should not exceed 3 times weekly.1 6

Special Populations Geriatric Patients

Select dosage with caution (usually initiating therapy at relatively low dosage) because of age-related decreases in hepatic, renal, and/or cardiac function and of concomitant disease and/or other drug therapies.1

Cautions for Venofer Contraindications

Known hypersensitivity to iron sucrose or any ingredient in the formulation.1

Evidence of iron overload.1

Anemias not associated with iron deficiency.1

Warnings/Precautions Warnings Sensitivity Reactions

Rare, potentially fatal sensitivity reactions, including anaphylactic shock, loss of consciousness, collapse, hypotension, dyspnea, and seizures.1 2 Immediate medical intervention and drug discontinuance required in such cases.1 Clinicians should be vigilant when administering any IV iron preparation.1

Cardiovascular Effects

Possible hypotension associated with IV administration; may be minimized by adhering to recommended total doses and rates of administration.1 (See Dosage and Administration.)

General Precautions Iron Toxicity

Withhold iron administration in patients with evidence suggesting iron overload because body iron excretion is limited and excessive iron in tissues can be hazardous.1 Periodically monitor laboratory values indicative of iron storage in the body (e.g., transferrin saturation, serum ferritin concentrations) to detect iron accumulation.1 6

Specific Populations Pregnancy

Category B.1

Lactation

Not known whether iron sucrose is distributed into milk; use caution in nursing women.1

Pediatric Use

Safety and efficacy not established in children <18 years of age.14

Geriatric Use

Insufficient experience in patients ?65 years of age to determine whether geriatric patients respond differently than younger adults; use caution in dosage selection and adjustment.1

Concomitant Disease States

Clinical studies generally excluded patients with serious underlying disease, inflammatory conditions, or active infections; use with caution.2 3 14

Common Adverse Effects

Hypotension, cramps/leg cramps, nausea, headache, vomiting, diarrhea.1

Interactions for Venofer Oral Iron Preparations

No formal drug interaction studies to date.1

Like other parenteral iron preparations, iron sucrose injection may be expected to reduce absorption of concomitantly administered oral iron.1

Venofer Pharmacokinetics Distribution Extent

Distributed into liver, spleen, and bone marrow.1

Elimination Metabolism

Following IV administration, dissociated into iron and sucrose by the reticuloendothelial system.1

Elimination Route

Sucrose component is eliminated mainly by urinary excretion.1

Half-life

6 hours.1

Special Populations

Serum clearance of iron expected to be more rapid in iron-deficient patients than in healthy individuals.1

Stability Storage Parenteral Injection

25°C (may be exposed to 15–30°C); do not freeze.1

Contains no preservatives; use immediately after opening vial(s).1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Iron sucrose injection should not be mixed with other drugs or added to parenteral nutrition solutions for IV infusion.1

ActionsActions

Has pharmacologic actions similar to those of other parenteral iron preparations (e.g., iron dextran, sodium ferric gluconate).1 4

Iron sucrose is free of ferrous ions and dextran polysaccharides, which are believed to be antigenic stimuli for anaphylactic reactions.5 7 8

Advice to Patients

Risk of potentially fatal sensitivity (e.g., anaphylactoid) reactions.1 8

Risk of hypotension.1

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Iron Sucrose

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for IV infusion

equivalent to 20 mg/mL of elemental iron

Venofer

American Regent

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. American Regent Laboratories. Venofer (iron sucrose) injection prescribing information. Shirley, NY; 2000 Dec.

2. Charytan C, Levin N, Al-Saloum M et al. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Am J Kidney Dis. 2001; 37:300-7. [IDIS 458970] [PubMed 11157370]

3. Van Wyck DB, Cavallo G, Spinowitz BS et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis. 2000; 36:88-97. [IDIS 450865] [PubMed 10873877]

4. Baille GR, Johnson CA, Mason NA. Parenteral iron products for anemia in end-stage renal disease: comparative considerations. Formulary. 2000; 35:498-513.

5. Sunder-Plassmann G, H?rl WH. Safety aspects of parenteral iron in patients with end-stage renal disease. Drug Saf. 1997; 17:241-50. [PubMed 9352960]

6. National Kidney Foundation. NKF/DOQI clinical practice guidelines for anemia of chronic kidney disease: update 2000. Am J Kidney Dis. 2001; 37(Suppl 1): S182-S238.

7. Geisser P, Baer M, Schaub E. Structure/histotoxicity relationship of parenteral iron preparations. Arzneim Forsch. 1992; 42:1439-52.

8. Fishbane S, Kowalski EA. The comparative safety of intravenous iron dextran, iron saccharate, and sodium ferric gluconate. Semin Dial. 2000; 13:381-4. [PubMed 11130261]

9. Health care financing administration. Medicare coverage policy decisions: venofer (iron sucrose injection) (#CAG-00080A) decision memorandum. From the HCFA website: ().

10. Domrongkitchaiporn S, Jirakranont B, Atamasrikul K et al. Indices of iron status in continuous ambulatory peritoneal dialysis patients. Am J Kidney Dis. 1999; 34:29-35. [IDIS 433261] [PubMed 10401012]

11. Silverberg DS, Blum M, Peer G et al. Intravenous ferric saccharate as an iron supplement in dialysis patients. Nephron. 1996; 72:413-7. [PubMed 8852489]

12. Silverberg DS, Iaina A, Peer G et al. Intravenous iron supplementation for the treatment of the anemia of moderate to severe chronic renal failure patients not receiving dialysis. Am J Kidney Dis. 1996; 27:234-8. [IDIS 361247] [PubMed 8659499]

13. Besarab A, Frinak S, Yee S. An indistinct balance: the safety and efficacy of parenteral iron therapy. J Am Soc Nephrol. 1999; 10:2029-43. [PubMed 10477157]

14. American Regent Laboratories, Shirley, NY; Personal communication.

15. Faich G, Strobos J. Sodium ferric gluconate in sucrose: safer intravenous iron therapy than iron dextrans. Am J Kidney Dis. 1999; 33(3): 464-70.

16. Nissenson AR, Lindsay RM, Swan S et al. Sodium ferric gluconate in sucrose is safe and effective in hemodialysis patients: North American clinical trial. Am J Kidney Dis. 1999; 33(3):471-82. [IDIS 424841] [PubMed 10070911]

More Venofer resources Venofer Side Effects (in more detail) Venofer Use in Pregnancy & Breastfeeding Venofer Drug Interactions Venofer Support Group 2 Reviews for Venofer - Add your own review/rating Venofer Prescribing Information (FDA) Venofer MedFacts Consumer Leaflet (Wolters Kluwer) Venofer Consumer Overview Iron Sucrose Professional Patient Advice (Wolters Kluwer) Compare Venofer with other medications Iron Deficiency Anemia
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Boots Nirolex Chesty Cough & Congestion Relief Linctus


Boots Nirolex Chesty Cough & Congestion Relief Linctus (Guaifenesin, Pseudoephedrine Hydrochloride)

Non drowsy

Relieves chesty coughs

Clears nasal congestion

120 ml e

Read all of this carton for full instructions.

What this medicine is for

This medicine contains Guaifenesin and Pseudoephedrine Hydrochloride, which act to relieve coughs and blocked noses.

It can be used to relieve the symptoms of chesty coughs, catarrh and blocked noses, without causing drowsiness.

Before you take this medicine Do not take: If you are allergic to any of the ingredients If you have heart or blood vessel disease, high blood pressure (including that due to a tumour near your kidney), glaucoma If you have severe kidney problems, diabetes, an overactive thyroid If you are taking monoamine oxidase inhibitors (for depression) or have taken them in the last 14 days If you have an intolerance to some sugars, unless your doctor tells you to (this medicine contains sucrose) If you are a man with prostate problems If you are pregnant Talk to your pharmacist or doctor: If you have other kidney problems (see above) If you take other medicines tricyclic antidepressants digoxin (for heart problems) medicines for high blood pressure other decongestants appetite suppressants or stimulants If you are breastfeeding Information about some of the ingredients:

The colour carmoisine (E122) in this medicine may cause allergic reactions.

How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Adults and children of 12 years and over
Take two 5ml spoonfuls 4 times a day.

Children of 6 to 11 years
Take one 5ml spoonful 3 times a day.

This medicine should be swallowed.

Do not give to children under 6 years.

Warning: Do not exceed the stated dose

If symptoms do not go away talk to your doctor.

If you take too much: Talk to doctor straight away.

Possible side effects

Most people will not have problems, but some may get some of these:

Feeling sick, being sick, stomach discomfort Headache Irritability, restlessness, confusion, shaking, difficulty sleeping, dizziness Fast heart beat, heart rhythm problems, palpitations, high blood pressure Difficulty in passing urine Skin rashes

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 30°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredients

Each 5 ml of oral solution contains Guaifenesin 100 mg, Pseudoephedrine Hydrochloride 30 mg.

Also contains: purified water, liquid sugar (sucrose), glycerol (E422), citric acid, sodium citrate, hyetellose, potassium sorbate (E202), acesulfame potassium, carmoisine (E122), patent V (E131), flavours (strawberry, blackcurrant, menthol, cream).

PL 00014/0555 [P]

Text prepared 11/07

Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham England NG2 3AA Other formats

To request a copy of this carton 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: Boots Nirolex Chesty Cough & Congestion Relief Linctus

Reference number: 00014/0555

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

If you need more advice ask your pharmacist.

BTC 23038 vD 28/03/08


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Vicks Cough Lozenges with Honey


Vicks Cough Lozenges with Honey

Dextromethorphan 7.33mg per Lozenge

In this leaflet: 1. What Vicks Cough Lozenges with Honey are and what they are used for 2. Before you take Vicks Cough Lozenges with Honey 3. How to take Vicks Cough Lozenges with Honey 4. Possible side effects 5. How to store Vicks Cough Lozenges with Honey 6. Further information Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Vicks Cough Lozenges with Honey carefully to get the best results from them.

Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. What Vicks Cough Lozenges with Honey are and what they are used for

Vicks Cough Lozenges with Honey contain the active ingredient Dextromethorphan which suppresses a cough by acting on the cough centre of the brain. These lozenges relieve dry coughs associated with colds and flu.

Before you take Vicks Cough Lozenges with Honey Do not take Vicks Cough Lozenges with Honey if you: are allergic to dextromethorphan or other ingredients (see section 6) have severe liver disease have a productive cough - (coughing produces mucus/phlegm). are taking medicines called monoamine oxidase inhibitors (MAOIs – a type of antidepressant) or have taken them in the last 14 days.

Do not give Vicks cough lozenges with honey to children under 12 years of age.

Take special care with Vicks Cough Lozenges with Honey

Talk to your doctor or pharmacist before taking this medicine if you:

have asthma you have ever had liver problems are diabetic or have difficulty digesting some sugars you have any long standing problems with your lungs Taking other medicines

Do not take Vicks Cough Lozenges with Honey if you are taking medicine
for depression or Parkinson’s disease called monoamine oxidase inhibitors (MAOIs) or have done so in the last 14 days.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking this product if you are pregnant or breast feeding.

Driving and using machines

If you feel dizzy, experience confusion or have symptoms of excitation (rapid pulse, hyperactivity or excessive sweating) do not drive or operate machinery.

Important information about some of the ingredients of Vicks Cough Lozenges with Honey:

Each lozenge contains 3.3g of sugar (as sucrose and glucose syrup). This should be taken into account if you are diabetic. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.

How to take Vicks Cough Lozenges with Honey

Always use Vicks Cough Lozenges with Honey exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage

Adults and children over 12 years : 2 lozenges, sucked one after the other.

Repeat the dose every 6 hours if required. Do not take more than 8 lozenges in 24 hours.

Do not give this medicine to children under 12 years of age.

Do not exceed the recommended dose.

If symptoms persist, speak to your pharmacist or doctor.

If you take more Vicks Cough Lozenges with Honey than you should

Seek medical advice immediately if you accidentally take more lozenges than you should.

If you forget to take Vicks Cough Lozenges with Honey

If you accidentally miss a dose, do not take a double dose; just take the next dose as normal.

Possible side effects

Like all medicines, Vicks Cough Lozenges with Honey can cause side effects, although not everyone gets them.

These may include: Dizziness Excitation (rapid pulse, hyperactivity or excessive sweating). Mental confusion Stomach upsets

If any side effects you experience become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Vicks Cough Lozenges with Honey

Keep out of the reach and sight of children.

Store below 25°C. Store in original packaging.

Do not take Vicks Cough Lozenges with Honey after the expiry date which is printed on the carton.

The expiry date refers to the last day of the month stated.

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 Vicks Cough Lozenges with Honey contain:

Active ingredient: 7.33 mg Dextromethorphan base per lozenge. Other ingredients: Sucrose, glucose syrup, honey, levomenthol, honey flavour, caramel flavour.

This pack contains 12 lozenges in a blister foil.

Marketing Authorisation Holder Procter & Gamble (Health & Beauty Care) Limited Weybridge Surrey KT13 0XP UK

(send all enquiries to this address).

Manufacturer: Procter & Gamble Manufacturing GmbH Procter & Gamble Strasse 1 64521, Gross Gerau Germany

PL 0129/0129

Text Revised: 04/2009

98873922


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Childrens Cetirizine Oral Solution



CHILDREN'S
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/1 mL
Antihistamine

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose itchy, watery eyes sneezing itching of the nose or throat Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

if breast-feeding: not recommended if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other information store between 20° to 25°C (68° to 77°F) Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose

Questions?

Call 1-866-923-4914

Distributed by: Chain Drug Consortium, LLC
2300 NW Corporate BLVD., Suite 115
Boca Raton, FL 33431
Made in Israel

PRINCIPAL DISPLAY PANEL - 120 mL bottle carton

NDC 68016-023-43

Ages
two years
and older

Compare to
the active ingredient
in Children's Zyrtec®*

Premier
Value®

CHILDREN'S
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/1 mL
Antihistamine

Grape Flavored Syrup

24 hour Allergy Relief of:
Sneezing; Runny Nose;
Itchy,Watery Eyes;
Itchy Throat or Nose

Indoor & Outdoor Allergies

Dosing Cup
Included

PV
PREMIER VALUE GUARANTEE

4 FL OZ (120 mL)


CHILDRENS CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride  solution Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 68016-023 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg  in 5 mL Inactive Ingredients Ingredient Name Strength acetic acid   glycerin   methylparaben   propylene glycol   propylparaben   water   sodium acetate anhydrous   sucrose   Product Characteristics Color YELLOW (colorless to slightly yellow) Score      Shape Size Flavor GRAPE, BANANA Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68016-023-43 1 BOTTLE In 1 CARTON contains a BOTTLE 1 120 mL In 1 BOTTLE This package is contained within the CARTON (68016-023-43)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090182 04/22/2008
Labeler - Chain Drug Consortium, LLC (Premier Value) (101668460) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Operations Taro Pharmaceutical Industries Ltd. 600072078 ANALYSIS, MANUFACTURE Revised: 04/2010Chain Drug Consortium, LLC (Premier Value)
More Childrens Cetirizine Oral Solution resources Childrens Cetirizine Oral Solution Side Effects (in more detail) Childrens Cetirizine Oral Solution Use in Pregnancy & Breastfeeding Drug Images Childrens Cetirizine Oral Solution Drug Interactions Childrens Cetirizine Oral Solution Support Group 73 Reviews for Childrens Cetirizine - Add your own review/rating Compare Childrens Cetirizine Oral Solution with other medications Hay Fever Urticaria
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MEDIJEL PASTILLES


1. Name Of The Medicinal Product

MEDIJEL PASTILLES

2. Qualitative And Quantitative Composition

Lignocaine Hydrochloride BP

0.25 % w/w

Aminacrine Hydrochloride BP 1968

0.025 %w/w

3. Pharmaceutical Form

Soft Pastille

4. Clinical Particulars 4.1 Therapeutic Indications

The quick effective relief from the pain of common mouth ulcers, soreness of gums and denture rubbing.

4.2 Posology And Method Of Administration

Place pastille against affected area and let it dissolve slowly. Repeat as necessary.

Each pastille weighs approximately 1.2g, i.e. 3mg of Lignocaine Hydrochloride and 0.3mg of Aminacrine Hydrochloride.

Medijel Pastilles can be used as directed for adults and children.

4.3 Contraindications

Hypersensitivity to the active substances or to any other of the ingredients.

Contains sucrose and glucose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.4 Special Warnings And Precautions For Use

If symptoms persist longer than 7 days following the use of the product, a doctor or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

The safety of Medijel Pastilles during pregnancy and lactation has not been established, but is considered not to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Hypersensitivity reactions to Lignocaine have been reported on rare occasions.

4.9 Overdose

Maximum safe dosage for a 70kg adult is 750mg for Lignocaine (Goodman & Gilman, page 313). A pack of Medijel pastilles contains approximately 75mg of Lignocaine Hydrochloride - overdose is not a problem.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lignocaine Hydrochloride is well documented in Martindale 28th Edition page 900 - 904 and Goodman & Gilman, chapter 15 and pages 767 - 770.

Lignocaine Hydrochloride was first introduced in 1948 and is one of the most widely used local anaesthetics. However, it produces more prompt, more intense, longer lasting and more extensive anaesthesia than does an equal concentration of procaine (Peak anaesthesia within 2-5 minutes). Local anaesthetics are drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They have good powers of penetration and their action is reversible. Their use is followed by complete recovery in nerve function with no evidence of structural damage to nerve fibres or cells.

Aminacrine Hydrochloride is a slow acting disinfectant. It exerts germicidal action against bacteria and fungi. It is also used as a surgical and endodontic irrigant and to treat local infections of the ear, mouth and throat. Its exact mode of action is not known but it involves disruption of certain metabolic pathways.

5.2 Pharmacokinetic Properties

Lignocaine is readily absorbed through mucous membranes. They exert their effects in the form of the non-ionised base. Lignocaine undergoes first-pass metabolism in the liver and bioavailablity is low after administration by mouth. It is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed by amidases to various compounds, including glycineexylidide which has reduced activity but a longer elimination half-life. Less than 10% of a dose is excreted unchanged via the kidneys. The metabolic products are excreted in the urine.

Aminacrine Hydrochloride if administered systematically is rapidly eliminated through the kidney (0.2 g being eliminated from the blood in 30 minutes. Medijel Pastilles dose 0.15mg Aminacrine Hydrochloride).

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 SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Hydroxypolyethoxydodecane HSE, Gelatin BP, Liquid Glucose BPC 1963, Sucrose EP,

Peppermint Oil BP, Levomenthol BP, Ethyl VanillinNF, Standard Green SE142,

Dextrose Monhydrate BP, Water (potable)

6.2 Incompatibilities

None encountered.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

No special storage conditions.

6.5 Nature And Contents Of Container

Aluminium Foil/Polyethylene laminate within coated boxboard carton.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

DDD Limited

94, Rickmansworth Road

Watford, Hertfordshire

United Kingdom

WDI8 7JJ

8. Marketing Authorisation Number(S)

PL 0133/5001R

Legal Status: Pharmacy Only

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 1972

10. Date Of Revision Of The Text

August 2009


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MEDIJEL GEL


1. Name Of The Medicinal Product

MEDIJEL GEL

2. Qualitative And Quantitative Composition Lidocaine Hydrochloride BP 0.66% w/w Aminoacridine Hydrochloride BP 1968 0.05% w/w 3. Pharmaceutical Form

Oral Gel

4. Clinical Particulars 4.1 Therapeutic Indications

The quick, effective relief from the pain of common mouth ulcers, soreness of gums and denture rubbing. Medijel Gel is administered directly onto the affected area with a clean finger or small pad of cotton wool.

4.2 Posology And Method Of Administration

The gel should be applied directly to the affected area(s) with a clean finger or small pad of cotton wool. If necessary application may be repeated after 20 minutes.

Each dose is approximately 300mg, i.e. 2mg of Lidocaine Hydrochloride and 0.15mg of Aminoacridine Hydrochloride. Medijel Gel can be used as directed for adults and children.

4.3 Contraindications

Hypersensitivity to the active substances or to any other of the ingredients.

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.4 Special Warnings And Precautions For Use

If symptoms persist longer than 7 days following the use of the product a doctor or dentist should be consulted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

The safety of Medijel Gel during pregnancy and lactation has not been established, but is considered not to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Hypersensitivity reactions to Lidocaine have been reported on rare occasions.

4.9 Overdose

Maximum safe dosage for a 70kg adult is 750mg for Lidocaine (Goodman & Gilman, page 313). A tube of Medijel Gel contains 82.5mg of Lidocaine hydrochloride - overdose is not a problem.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lidocaine Hydrochloride is well documented in Martindale 28th Edition Page 900-904 and Goodman & Gilman, Chapter 15 and pages 767-770.

Lidocaine Hydrochloride was first introduced in 1948 and is one of the most widely used local anaesthetics, producing more prompt, more intense, longer lasting and more extensive anaesthesia than does an equal concentration of procaine (Peak anaesthesia within 2-5 minutes). Local anaesthetics are drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They have good powers of penetration and their action is reversible. Their use is followed by complete recovery in nerve function with no evidence of structural damage to nerve fibres or cells.

Aminoacridine Hydrochloride is a slow acting disinfectant. It exerts germicidal action against bacteria and fungi. It is also used as a surgical and endodontic irrigant and to treat local infections of the ear, mouth and throat. Its exact mode of action is not known but it involves disruption of certain metabolic pathways.

5.2 Pharmacokinetic Properties

Lidocaine is readily absorbed through mucous membranes. They exert their effects in the form of the non-ionised base. Lidocaine undergoes first-pass metabolism in the liver and bioavailability is low after administration by mouth. It is rapidly de-ethylated to the active metabolite monoethylglycinexylidide and then hydrolysed by amidases to various compounds, including glycineexylidide which has reduced activity but a longer elimination half-life. Less than 10% of a dose is excreted unchanged via the kidneys. The metabolic products are excreted in the urine.

Aminoacridine Hydrochloride if administered systematically is rapidly eliminated through the kidney (0.2 grams being eliminated from the blood in 30 minutes). (Medijel Gel dose 0.15mg Aminoacridine hydrochloride).

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 SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Glycerol , Hydroxypolyethoxydodecane HSE, Alcohol 96% v/v, Carbomer, Sucrose, Saccharin Sodium, Peppermint Oil, Ethyl vanillin, Di-isopropanolamine 90% aqueous, Purified Water

6.2 Incompatibilities

None encountered.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium tube with membrane seal and spiked polyethylene cap.

6.6 Special Precautions For Disposal And Other Handling

N/A

7. Marketing Authorisation Holder

DDD LIMITED

94, Rickmansworth Road, Watford, Hertfordshire, United Kingdom, WDI8 7JJ.

8. Marketing Authorisation Number(S)

PL 0133/5000R

Legal Status: GSL

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of last renewal: 20/05/03

10. Date Of Revision Of The Text

March 2010


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