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.
•   Replacement therapy:

As this drug norditropin NordiFlex is using to regulate the human growth hormone (  HGH ), so this treatment with exogenous growth hormone is indicated only in limited circumstances and needs to regulate monitoring to the frequency and severity of side – effect. Growth hormones are used as replacement therapy in adults with growth hormone deficiency of either childhood-onset or adult-onset set ( usually as a result of an acquired pituitary tumor) . in these patients especially in adults, benefits have variably included reduced fat mass, increased lean mass, increased bone density, improved lipid profile, reduced cardiovascular risk factors, and improved psychosocial well – being.

•   other approved uses:

growth hormone can be used to treat conditions that produce short stature but are not related to deficiencies in growth hormone. However, results are not as dramatic when compared to short stature that is solely attributable to deficiency of growth hormone. Examples of other causes of shortness often treated with GH are Turner syndrome, chronic renal failure, Prader – Willi syndrome, intrauterine growth restriction, and severe idiopathic short stature. Higher pharmacologic doses are required to produce significant acceleration of growth in these conditions, producing blood levels well above normal physiological.  Despite the higher doses, its side – effects during treatment are very rare, and very rare according to the condition being treated,

one version of human growth hormone has also been FDA approved for maintaining muscle mass in wasting due to AIDS

this drug is very useful for the HGH replacement.

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.

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

Additional side effects in children:

Uncommon (may affect up to 1 in 100 children):

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

Rare (may affect up to one in 1,000 children):

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

In rare cases, children using Norditropin NordiFlex 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-Calvé disease) or because the end of the bone has slipped from the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin NordiFlex.

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.

Additional side effects in adults:

Very common (may affect more than 1 in 10 adults):

•   Swollen hands and feet due to fluid retention.

Common (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 (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