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Norditropin Simplexx 10mg / 1.5ml



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Norditropin SimpleXx 10 mg/1.5 ml

solution for injection in cartridges

Somatropin

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again. If you have further questions, ask your doctor or pharmacist. This medicine has been prescribed for you personally. 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 or pharmacist.

In this leaflet: 1. What Norditropin SimpleXx is and what it is used for 2. Before you use Norditropin SimpleXx 3. How to use Norditropin SimpleXx 4. Possible side effects 5. How to store Norditropin SimpleXx 6. Further information. What Norditropin SimpleXx is and what it is used for

Norditropin SimpleXx contains a biosynthetic human growth hormone called somatropin which is identical to the growth hormone produced naturally in the body. Children need growth hormone to help them grow, but adults also need it for their general health.

Norditropin SimpleXx comes as a solution in a cartridge ready for you to inject after you have put it in the matching NordiPen injection pen.

Norditropin SimpleXx is used to treat growth failure in children:

If they have no or very low production of growth hormone If they have Turner syndrome (a genetic problem which may affect growth) If they have reduced kidney function If they are short and were born small for gestational age (SGA).

Norditropin SimpleXx is used as a growth hormone replacement in adults:

In adults Norditropin SimpleXx is used to replace growth hormone if their growth hormone production has been decreased since childhood or has been lost in adulthood because of a tumour, treatment of a tumour or a disease that affects the gland which produces growth hormone.

Before you use Norditropin SimpleXx Do not use Norditropin SimpleXx If you are allergic (hypersensitive) to somatropin, to phenol or to any of the other ingredients of Norditropin SimpleXx (listed in section 6, Further information) If you have had a kidney transplant If you are pregnant or breast-feeding (See pregnancy and breast-feeding) If you have a cancer, a tumour or are still in anti-tumour therapy If you have an acute critical illness e.g. open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure. Take special care with Norditropin SimpleXx If you have diabetes If you have ever had a cancer or another kind of tumour If you have recurrent headaches, eyesight problems, nausea or if vomiting occurs If you have abnormal thyroid function If you develop scoliosis If you are over 60 years of age, or have received somatropin treatment as an adult for more than 5 years, as experience is limited If you suffer from kidney disease your kidney function should be monitored by your physician.

Tell your doctor if any of these apply to you as Norditropin SimpleXx may not be suitable.

Using other medicines

Your doctor needs to know if you are already being treated with:

Glucocorticoids or sex steroids – your adult height may be affected if you use Norditropin SimpleXx and glucocorticoids or sex steroids at the same time Insulin - as your dose may need to be adjusted Thyroid hormone.

Tell your doctor or pharmacist if you are taking other medicines or have recently taken any. This includes medicines obtained without a prescription.

Pregnancy and breast-feeding Pregnancy. Stop the treatment and tell your doctor if you become pregnant while you are using Norditropin SimpleXx Breast-feeding. Do not use Norditropin SimpleXx while you are breast-feeding as somatropin might pass into your milk. Driving and using machines

Norditropin SimpleXx does not affect the use of any machines or the ability to drive safely.

How to use Norditropin SimpleXx

Always use Norditropin SimpleXx exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure.

Usual dose

The dose for children depends on their body weight and body surface area. The adult dose depends on height, weight, gender and growth hormone sensitivity and will be adjusted until you are on the right dose.

Children with low production or lack of growth hormone: The usual dose is 25 to 35 microgram per kg body weight per day or 0.7 to 1.0 mg per m? body surface area per day. Children with Turner syndrome: The usual dose is 45 to 67 microgram per kg body weight per day or 1.3 to 2.0 mg per m? body surface area per day. Children with kidney disease: The usual dose is 50 microgram per kg body weight per day or 1.4 mg per m? body surface area per day. Children born small for gestational age (SGA): The usual dose is 35 microgram per kg body weight per day or 1.0 mg per m? body surface area per day until final height is reached. (In clinical trials of short children born SGA doses of 33 and 67 microgram per kg body weight per day have typically been used.) Adults with low production or lack of growth hormone: The usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose each month until you are on the right dose. The usual maximum dose is 1.0 mg per day. When to use Norditropin SimpleXx Inject your daily dose into the skin every evening just before bedtime. Using the cartridges to inject yourself Norditropin SimpleXx solution comes in cartridges ready to be used in the matching NordiPen. The NordiPen instruction manual tells you how to use the cartridges in the injection pen Check each new Norditropin SimpleXx cartridge before you use it. Do not use any cartridge that is damaged or cracked Only use a Norditropin SimpleXx cartridge if the solution inside is clear and colourless Vary the area you inject so you do not harm your skin Do not share your Norditropin SimpleXx cartridge with anyone else. How long you will need treatment for If you are using Norditropin SimpleXx for growth failure because of Turner syndrome, a kidney disease or if you were born small for gestational age (SGA), continue using Norditropin SimpleXx until you stop growing If you lack growth hormone, continue using Norditropin SimpleXx into adulthood Do not stop using Norditropin SimpleXx without discussing it with your doctor first. If you use too much: Tell your doctor if you inject too much Norditropin SimpleXx. Long-term overdosing can cause abnormal growth and coarsening of facial features. If you forget a dose: Take the next dose as usual, at the normal time. Do not take a double dose to make up for a forgotten dose. Possible side effects

Like all medicines, Norditropin SimpleXx can cause side effects, although not everybody gets them.

Very rare effects in children and adults

(may affect up to 1 in 10,000 people):

Rash; wheezing; swollen eyelids, face or lips; complete collapse. Any of these may be signs of allergic reactions Headache, eyesight problems, feeling sick (nausea) and being sick (vomiting).
These may be signs of raised pressure in the brain Serum thyroxin levels may decrease

If you get any of these effects, see a doctor as soon as possible. Stop using Norditropin SimpleXx until your doctor says you can continue treatment.

Formation of antibodies directed against somatropin has been rarely observed during Norditropin therapy.

Cases of leukaemia and relapse of brain tumours have also been reported in patients treated with somatropin (the active ingredient in Norditropin SimpleXx), although there is no evidence that somatropin was responsible.

If you think you are suffering from any of these diseases, speak to your doctor.

Other side effects in children:

Uncommon effects

(may affect up to 1 in 100 children):

Headache Redness, itching and pain in the area of injection.

Rare effects

(may affect up to 1 in 1000 children):

Rash Muscle and joint pain Swollen hands and feet due to fluid retention.

In rare cases, children using Norditropin SimpleXx have experienced hip and knee pain or have started limping. These symptoms may be caused by a disease affecting the top of the thigh bone (Legg-Calv? disease) or because the end of the bone has slipped from the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin SimpleXx.

In children with Turner syndrome, a few cases of increased growth of hands and feet compared to height have been observed in clinical trials.

A clinical trial in children with Turner syndrome has shown that high doses of Norditropin can possibly increase the risk of getting ear infections.

Other side effects in adults:

Very common effects

(may affect more than 1 in 10 adults):

Swollen hands and feet due to fluid retention.

Common effects

(may affect up to 1 in 10 adults):

Headache Feeling of skin crawling (formication) and numbness or pain mainly in fingers Joint pain and stiffness; muscle pain.

Uncommon effects

(may affect up to 1 in 100 adults):

Type 2 diabetes Carpal tunnel syndrome tingling and pain in fingers and hands Itching (can be intense) and pain in the area of injection Muscle stiffness.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist, as you may need to reduce your dose.

How to store Norditropin SimpleXx

Keep out of the reach and sight of children.

Do not use Norditropin SimpleXx after the expiry date which is stated on the package.

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

Store unused Norditropin SimpleXx cartridges in a refrigerator (2°C to 8°C) in the outer carton, in order to protect from light. Do not freeze or expose to heat.

After starting to use a Norditropin SimpleXx 10 mg/1.5 ml cartridge in an injection pen you can either:

Keep it in the pen for up to 4 weeks in a refrigerator (2°C and 8°C), or Keep it in the pen for up to 3 weeks at room temperature (below 25°C).

Do not continue to use Norditropin SimpleXx cartridges which have been frozen or exposed to excessive temperatures.

Check each new Norditropin SimpleXx cartridge before you use it. Do not use any cartridge that is damaged or cracked.

Do not use any Norditropin SimpleXx cartridge if the solution inside is not clear and colourless.

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 Norditropin SimpleXx contains The active substance is somatropin The solution also contains mannitol; histidine; poloxamer 188; phenol; water for injections; hydrochloric acid and sodium hydroxide. What Norditropin SimpleXx looks like and contents of the pack

Norditropin SimpleXx is a clear and colourless solution in a 1.5 ml glass cartridge ready for injection in the NordiPen injection pen.

1 ml of solution contains 6.7 mg somatropin.

1 mg of somatropin corresponds to 3 IU of somatropin.

Norditropin SimpleXx is available in three strengths:

5 mg/1.5 ml, 10 mg/1.5 ml and 15 mg/1.5 ml (equivalent to 3.3 mg/ml, 6.7 mg/ml and 10 mg/ml, respectively).

Manufacturer

Norditropin SimpleXx is made by:

Novo Nordisk A/S Novo All? DK-2880 Bagsv?rd Denmark Marketing authorisation holder Novo Nordisk Limited Broadfield Park Brighton Road Crawley West Sussex RH11 9RT UK

This leaflet was last approved in 02/2010.

Norditropin and SimpleXx are Trademarks owned by Novo Nordisk Health Care AG Switzerland

NordiPen is a trademark owned by Novo Nordisk A/S, Denmark

© 1999 / 2008

8-2071-01-002-4







Norditropin Simplexx 10mg 1.5ml

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