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 (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 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. 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.
2. What you need to know before you use Norditropin® SimpleXx®
Do not use NORDITROPIN SIMPLEXx
If you are allergic to somatropin, to phenol, or to any of the other ingredients of this medicine
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
If you have an acute critical illness e.g. open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure
If you have stopped growing (closed epiphyses) and you do not have growth hormone deficiency.
Warnings and precautions
Talk to you doctor or pharmacist before using Norditropin
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
Tell your 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 or of the other medicines:
Glucocorticoids – your adult height may be affected if you use Norditropin 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.
Pregnancy. Stop the treatment and tell your doctor if you become pregnant while you are using Norditropin
Breast-feeding. Do not use NORDITROPIN SIMPLEXx while you are breast-feeding as somatropin might pass into your milk.
Driving and using machines
Norditropin does not affect the use of any machines or the ability to drive safely.
3. How to use NORDITROPIN SIMPLEXx
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 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 0.025 to 0.035 mg per kg body weight per day or 0.7 to 1.0 mg per m2 body surface area per day
Children with Turner syndrome: The usual dose is 0.045 to 0.067 mg per kg body weight per day or 1.3 to 2.0 mg per m2 body surface area per day
Children with kidney disease: The usual dose is 0.05 mg per kg body weight per day or 1.4 mg per m² body surface area per day
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