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It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above. The product code s for this leaflet is: Read all of this leaflet carefully before you start using this medicine because it contains important information for you. What Norditropin NordiFlex is and what it is used for 2. What you need to know before you use Norditropin NordiFlex 3.
How to use Norditropin NordiFlex 4. Possible side effects 5. How to store Norditropin NordiFlex 6. Contents of the pack and other information. Norditropin NordiFlex 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 NordiFlex is used to treat growth failure in children:. Norditropin NordiFlex is used as a growth hormone replacement in adults:.
In adults Norditropin NordiFlex 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.
If you have been treated for growth hormone deficiency during childhood, you will be retested after completion of growth. If growth hormone deficiency is confirmed, you should continue treatment.
Tell you doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, inform your doctor if you are taking or have recently taken any of the following medicines. Your doctor may need to adjust the dose of Norditropin NordiFlex or of the other medicines:.
Somatropin containing products are not recommended in women of childbearing potential not using contraception. Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The dose for children depends on their body weight and body surface area.
Later in life, the dose depends on your height, weight, gender, and growth hormone sensitivity and will be adjusted until you are on the right dose. Norditropin NordiFlex growth hormone solution comes in a multi-dose disposable 1. Full instructions on how to use the Norditropin NordiFlex pen are given overleaf.
The instructional key points are as follows:. If you get any of these effects, see a doctor as soon as possible. Stop using Norditropin NordiFlex 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 NordiFlex , although there is no evidence that somatropin was responsible.
In rare cases, children using Norditropin NordiFlex have experienced hip and knee pain or have started limping. 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.
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 the dose may need to be reduced.
If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: By reporting side effects you can help provide more information on the safety of this medicine.
The expiry date refers to the last day of that month. Do not freeze or expose to heat. Do not continue to use a Norditropin NordiFlex pen if they have been frozen or exposed to excessive temperatures. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Norditropin NordiFlex is a clear and colourless solution for injection in a multi-dose disposable 1.
You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours If you get any side effects talk to your doctor or pharmacist. What is in this leaflet: Contents of the pack and other information Overleaf: Using your Norditropin NordiFlex pen.
What Norditropin NordiFlex is and what it is used for Norditropin NordiFlex contains a biosynthetic human growth hormone called somatropin which is identical to the growth hormone produced naturally in the body. Norditropin NordiFlex is used to treat growth failure in children: If they have no or very low production of growth hormone growth hormone deficiency 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 NordiFlex is used as a growth hormone replacement in adults: What you need to know before you use Norditropin NordiFlex Do not use Norditropin NordiFlex If you are allergic to somatropin, to phenol, or to any of the other ingredients of this medicine listed in section 6 If you have had a kidney transplant If you have an active tumour cancer.
Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with Norditropin NordiFlex If you have an acute critical illness e. Warnings and precautions Talk to you doctor or pharmacist before using Norditropin NordiFlex 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 a limp or low-back pain as these could be signs of a curved spine 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 as your kidney function should be monitored by your physician If you have a replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need adjustment of your glucocorticoid dose.
Other medicines and Norditropin NordiFlex Tell you doctor or pharmacist if you are using, have recently used or might use any other medicines. Your doctor may need to adjust the dose of Norditropin NordiFlex or of the other medicines: Glucocorticoids — your adult height may be affected if you use Norditropin NordiFlex and glucocorticoids at the same time Cyclosporin immunosuppressive — as your dose may need to be adjusted Insulin — as your dose may need to be adjusted Thyroid hormone — as your dose may need to be adjusted Gonadotrophin gonad stimulating hormone — as your dose may need to be adjusted Anticonvulsants — as your dose may need to be adjusted Oestrogen taken orally or other sex hormones.
Pregnancy and breast-feeding Somatropin containing products are not recommended in women of childbearing potential not using contraception. Stop the treatment and tell your doctor if you become pregnant while you are using Norditropin NordiFlex Breast-feeding.
Do not use Norditropin NordiFlex while you are breast-feeding because somatropin might pass into your milk. Driving and using machines Norditropin NordiFlex does not affect the use of any machines or the ability to drive safely.
How to use Norditropin NordiFlex Always use this medicine exactly as your doctor has told you. Recommended dose The dose for children depends on their body weight and body surface area. Children with low production or lack of growth hormone: The usual dose is 0.
In clinical trials of short children born SGA doses of 0. If your growth hormone deficiency continues after completion of growth, treatment should be continued. The usual starting dose is 0. Dose will be adjusted until you are on the right dose. If your growth hormone deficiency starts during adult life, the usual starting dose is 0.
Your doctor will increase this dose each month until you are getting the dose you need. The usual maximum dose is 1. When to use Norditropin NordiFlex Inject your daily dose into the skin every evening just before bedtime. The instructional key points are as follows: Check the solution before use by turning the pen upside down once or twice. Do not use the pen if a drop of hormone solution does not appear at the needle tip Do not share your Norditropin NordiFlex pen with anyone else.
How long you will need treatment for Children with growth failure because of Turner syndrome, kidney disease, or SGA: Your doctor will recommend you continue treatment until you stop growing Children or adolescents who lack growth hormone: Your doctor will recommend you continue treatment into adulthood Do not stop using Norditropin NordiFlex without discussing it with your doctor first.
If you use more Norditropin NordiFlex than you should Tell your doctor if you inject too much somatropin. Long-term overdosing can cause abnormal growth and coarsening of facial features.
If you forget to use Norditropin NordiFlex 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, this medicine can cause side effects, although not everybody gets them. Effects seen in children and adults unknown frequency: