Norditropin 45i.u.

Norditropin 45i.u.

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:

• 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:

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.

Recommended dose

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.

• 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 0.050 mg per kg body weight per day or 1.4 mg per m² body surface area per day.
• Children born small for gestational age (SGA):
  The usual dose is 0.035 mg per kg body weight per day or 1.0 mg per m² body surface area per day until final height is reached. (In clinical trials of short children born SGA doses of 0.033 and 0.067 mg per kg body weight per day have typically been used).
• Adults with low production or lack of growth hormone:
  If your growth hormone deficiency continues after completion of growth, treatment should be continued. The usual starting dose is 0.2 to 0.5 mg per day. 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 0.1 to 0.3 mg per day. Your doctor will increase this dose each month until you are getting the dose you need. The usual maximum dose is 1.0 mg per day.

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):

• 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.
• Hyperglycaemia (elevated levels of blood glucose).

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.

Increased levels of liver enzymes have been reported.

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.