Norditropin NordiFlex 45 IU

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); If they have Noonan syndrome (a genetic problem which may affect growth).

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.

Do not use Norditropin NordiFlex: If you are allergic to Somatropin, to phenol, or to any of the other ingredients of Norditropin NordiFlex; If you have had a kidney transplant; If you have an active tumour (cancer). Tumours must be inactive and you must have finished your antitumour treatment before you start your treatment with Norditropin NordiFlex; 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.

Like all medicines, Norditropin NordiFlex 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 an allergic reaction. 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 rarely been 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 for this.

If you think you are suffering from any of these diseases, talk to your doctor. If you get any side effect, talk to your doctor or pharmacist.

Keep Norditropin NordiFlex out of the sight and reach of children.

Do not use Norditropin NordiFlex after the expiry date which is stated on the package after EXP/. The expiry date refers to the last day of that month.

Store unused Norditropin NordiFlex pens in a refrigerator (2°C – 8°C) in the outer carton, in order to protect them from light. Do not freeze or expose to heat. Do not store close to any cooling elements.