Norditropin NordiFlex – Somatropin uses, dose and side effects


5 mg / 1.5 ml solution for injection in a pre-filled pen somatropin

What Norditropin NordiFFlex is and what it is used for

Norditropin NordiFlex contains a biosynthetic human growth hormone called somatropin. It is identical to the growth hormone, which is produced naturally in the body. Children need growth hormone to grow, but adults also need it to feel good.

Norditropin NordiFlex is used for treating growth disorders in children:

  • if they lack or have very low growth hormone production ( growth hormone deficiency)
  • if they have Turner syndrome (hereditary disorders that can affect growth)
  • if they have impaired kidney function
  • if they are short in stature and born small in relation to the length of the fetal period ( SGA )
  • if they have Noonan’s syndrome (hereditary disorders that can affect growth).

Norditropin NordiFlex is used as growth hormone replacement in adults:

In adults, Norditropin NordiFlex is used to restore growth hormone levels if production has been too low since childhood or if it has ceased in adulthood due to tumor, tumor treatment, or disease that has affected the growth hormone-producing gland. If you have been treated for growth hormone deficiency in childhood, you will be tested again after you have stopped growing. If growth hormone deficiency is diagnosed, treatment should be continued.

What you need to know before using 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 tumor (cancer). Tumors must be inactive and you must have stopped cancer treatment before starting treatment with Norditropin NordiFlex
  • in an acute critical condition in connection with, for example, open heart surgery or abdominal surgery, complicated bodily injuries (due to an accident) or in the event of acute impaired breathing ability
  • if you have stopped growing (closed epiphyses) and you do not have growth hormone deficiency.

Warnings and cautions

Talk to your doctor or pharmacist before using Norditropin NordiFlex

  • if you have diabetes
  • if you have had cancer or another tumor form
  • if you have recurrent headaches, visual disturbances, nausea or if you experience vomiting
  • if you have impaired thyroid function
  • an increased curvature of the spine laterally (scoliosis) can be exacerbated in all children who grow rapidly. During treatment with Norditropin Nordiflex, your doctor will examine you (or your child) for signs of scoliosis
  • if you are lame or start to limp during growth hormone treatment , tell your doctor
  • if you are over 60 years of age or have been treated with somatropin as an adult for more than 5 years, then the experience of these groups is limited
  • If you have a kidney disease, then your kidney function should be followed up by a doctor.
  • If you have a replacement therapy with glucocorticoids , you should consult your doctor regularly, as you may need to adjust your glucocorticoid dose.
  • Norditropin NordiFlex can cause inflammation of the pancreas ( pancreatitis ), causing severe pain in the abdomen and back. Contact your doctor if you or your child has a stomach ache after taking Norditropin NordiFlex.

Other medicines and Norditropin NordiFlex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell 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 other medicines:

  • Glucocorticoids ( cortisone ), as your height as an adult can be affected if you use Norditropin NordiFlex and glucocorticoids at the same time
  • Ciclosporin (inhibits the immune system), 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
  • Gonadotropin ( a hormone that regulates the gonads ), as your dose may need to be adjusted
  • Epilepsy medication, as your dose may need to be adjusted.
  • Estrogen taken by mouth or other sex hormones.

Pregnancy and breastfeeding

Medicines containing somatropin are not recommended for women of childbearing potential not using contraception.

  • Pregnancy – Discontinue treatment and contact your doctor if you become pregnant while being treated with Norditropin NordiFlex
  • Breast-feeding – You should not use Norditropin NordiFlex if you are breast-feeding, as somatropin may pass into breast milk.

Driving and using machines:

Norditropin NordiFlex does not affect the use of machines or your ability to drive.

Norditropin contains sodium

Norditropin contains less than 1 mmol sodium (23 mg) per 1.5 ml, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Norditropin NordiFlex

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Recommended dose

Dosage in children depends on their body weight and body surface area. Later in life, dose one depends on the height, weight, gender, and the body’s ability to respond to growth hormone and is adjusted until the right dose is reached.

  • Children with low production or lack of plant hormone:
  • The usual dose is 0.025-0.035 mg per kilogram of body weight and day or 0.7–1.0 mg per m 2 of body surface area and day.
  • Children with Turner syndrome: The usual dose is 0.045-0.067 mg per kilogram of body weight per day or 1.3–2.0 mg per m 2 of body surface area and day.
  • Children with kidney disease: The usual dose is 0.050 mg per kilogram body weight and day or 1.4 mg per m 2 body surface area and day
  • Children born small in relation to the length of the fetal period ( SGA ):
  • The usual dose is 0.035 mg per kilogram of body weight and day or 1.0 mg per m 2 of body surface area and day until the final length is reached. (In clinical trials in short children with SGA , doses of 0.033 and 0.067 mg per kilogram body weight per day have been used.)
  • Children with Noonan’s syndrome:
  • The usual dose is 0.066 mg per kilogram of body weight per day. However, your doctor may decide that 0.033 mg per kilogram of body weight per day is sufficient.
  • Adults with low production or growth hormone deficiency: If your growth hormone deficiency persists after you stop growing, treatment should be continued. The usual starting dose is 0.2-0.5 mg. Dose one is adjusted until you get the right dose . If your growth hormone deficiency has developed in adulthood, the usual starting dose is 0.1-0.3 mg / day. Your doctor will increase this dose every month until you reach the dose you need. The maximum dose is usually 1.0 mg / day.

When on the day Norditropin NordiFlex should be used

Inject your daily dose under the skin ( subcutaneously ) every night just before going to bed.

How to use the pen

Norditropin NordiFlex growth hormone solution is supplied in a 1.5 ml pre-filled multi-dose pen, which is discarded when empty.

Complete instructions for use for the Norditropin NordiFlex pen can be found on the following page, but here are some important points:

  • Check the solution before use by turning the pen upside down a couple of times. Do not use the pen if the solution is cloudy or discolored
  • Norditropin NordiFlex is designed to be used with NovoFine or NovoTwist disposable injection needles up to 8 mm in length
  • Always use a new injection needle for each injection
  • Vary the injection site so that your skin is not damaged
  • Check the flow of growth hormone before the first injection with a new Norditropin NordiFlex pen to make sure you are getting the right dose and not injecting air. Do not use the pen unless a drop of growth hormone solution is visible on the tip of the needle
  • Do not share your Norditropin NordiFlex pen with anyone else.

How long do you need to receive treatment

  • Children with growth retardation due to Turner syndrome , kidney disease, SGA or Noonan’s syndrome: Your doctor will recommend that you continue treatment until you stop growing
  • Children or adolescents with growth hormone deficiency: Your doctor will recommend that you continue treatment until adulthood

Do not stop using Norditropin NordiFlex without first consulting your doctor.

If you take more Norditropin NordiFlex than you should

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Prolonged overdose can cause abnormal growth and coarser facial features.

If you forget to take Norditropin NordiFlex

Take the next dose as usual at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Norditropin NordiFlex

Do not stop using Norditropin NordiFlex without first discussing it with your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects in children and adults (no known frequency):

  • Rash; rustling breathing; swollen eyelids, face or lips; complete collapse. These symptoms may be a sign of an allergic reaction
  • Headache, visual disturbances, nausea and vomiting. This may be a sign of an increase in pressure inside the brain
  • Blood levels of thyroxine (thyroid hormone) may decrease
  • Blood levels of glucose may increase ( hyperglycaemia ).

If you get any of these side effects, talk to your doctor as soon as possible. Do not use Norditropin NordiFlex but wait until your doctor tells you to continue treatment.

Development of antibodies to somatropin has in rare cases been observed during treatment with Norditropin

Increased levels of liver enzymes have been reported.

Leukemia and recurrence of brain tumors have been reported in people treated with somatropin (the active ingredient in Norditropin NordiFlex), but there is no evidence that they have been caused by somatropin.

If you think you have any of these conditions, consult your doctor.

Additional side effects are in children:

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

  • Headache
  • Redness , itching and pain at the injection site
  • Breast augmentation ( gynecomastia ).

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

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

In rare cases, children treated with Norditropin NordiFlex have experienced pain in the hip or knee or started to limp. The cause may be a disease that affects the upper part of the femur ( Legg-Calvé Perthes disease ) or may be due to the bone end of the femur slipping away from the cartilage ( epiphyseal slippage in the caput femoris ) and does not have to be caused by Norditropin NordiFlex.

In children with Turner syndrome, a few cases of increased growth of hands and feet compared to height have been noted in clinical trials.

A clinical trial of children with Turner syndrome showed that high doses of Norditropin may increase the risk of ear infections.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Additional side effects are 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
  • Ant crawling and numbness or pain mainly in fingers
  • Joint pain and stiffness; muscle pain.

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

  • Type 2 diabetes
  • Carpal tunnel syndrome (tingling and pain in fingers and hands)
  • Itching (sometimes intense) and pain at the injection site
  • Muscle stiffness
  • Breast augmentation ( gynecomastia ).

How to store Norditropin NordiFlex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”. The expiration date is the last day of the specified month.

Norditropin NordiFlex pens, not used, are stored in a refrigerator (2 ° C – 8 ° C) in the outer carton. Sensitive to light. Do not freeze or expose to heat. Do not store near a cooling element.

While you are taking Norditropin NordiFlex 5 mg / 1.5 ml you can either:

  • store it for up to 4 weeks in a refrigerator (2 ° C – 8 ° C) or
  • store it for up to 3 weeks at room temperature (maximum 25 ° C).

Do not continue to use a Norditropin NordiFlex pen that has been frozen or exposed to extreme heat.

Do not use Norditropin NordiFlex pens if the growth hormone solution is cloudy or discolored.

Always keep Norditropin NordiFlex without a hypodermic needle.

Always keep the Norditropin NordiFlex pen with the cap properly attached when not in use. Always use a new injection needle for each injection.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

What the medicine looks like and the contents of the pack

Norditropin NordiFlex is a clear and colorless solution for injection in a 1.5 ml pre-filled multi-dose pen, which is discarded when empty.

1 ml solution contains 3.3 mg somatropin.

1 mg somatropin is equivalent to 3 IU somatropin.

Norditropin NordiFlex is available in three strengths:

5 mg / 1.5 ml, 10 mg / 1.5 ml, 15 mg / 1.5 ml (corresponding to 3.3 mg / ml, 6.7 mg / ml and 10 mg / ml, respectively).

Marketing Authorization Holder and Manufacturer

Novo Nordisk A / S

Novo Allé

DK-2880 Bagsværd


This medicinal product is authorized under the European Economic Area under the names:

Austria, Belgium, Cyprus, Czech Republic, Denmark, Greece, Finland, Hungary, Croatia, Ireland, Iceland, Italy, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Spain, Sweden, Slovakia, Slovenia, United Kingdom: Norditropin NordiFlex 5 mg / 1.5 ml

France: Norditropine NordiFlex 5 mg / 1.5 ml

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