Norditropin ® 5 mg Solution

Norditropin ® 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.

Norditropin ® is used to treat growth failure in children, which is caused by:

• No or very low production of growth hormone (growth hormone deficiency)
• Turner syndrome (a genetic problem which may affect growth)

Your child should not be given Norditropin ® :

• if they are hypersensitive (allergic) to somatropin or to any of the other ingredients of Norditropin ® (see section 6)
• if they have/had cancer or other forms of tumour
• if they receive treatment for cancer or a tumour
• If they have stopped growing (closed epiphyses) and do not have a growth hormone deficiency
• if they have an acute critical illness or have complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions
• if they have proliferative or pre-proliferative diabetic retinopathy
• if they have sugar diabetes (type I and II) which is uncontrolled or poorly controlled
• if they are pregnant or breastfeeding a baby.

Warnings and precautions

Special care should be taken with Norditropin ® :

• If your child develops a limp or low back pain, as these could be signs of a curved spine (scoliosis).
• If your child has diabetes (high blood sugar) or is at risk of developing diabetes (has a family history of diabetes, is severely overweight, suffers from insulin resistance).
• If your child develops a limp, or have hip or knee pain, as these could be signs of Legg-Calvé disease or Slipped capital femoral epiphysis.
• If your child has severe or recurrent headaches, eyesight problems, nausea or if vomiting occurs. These could be signs of benign intracranial hypertension.
• If your child has abnormal thyroid function, because treatment with Norditropin ® can affect thyroid function.
• If your child fails to respond to treatment, as this could be a sign of formation of antibodies against somatropin. Your child should then be tested for antibodies.
• If your child is in complete remission for leukaemia. Your child should have regular follow-ups with his or her doctor.
• If your child has Turner syndrome. It is recommended that your child’s doctor should measure IGF-1 levels before the start of treatment and regularly thereafter.
• If your child has Turner syndrome. Your doctor should closely monitor the growth of their hands and feet. If increased growth is observed, a reduction in the dose of Norditropin ® may be considered.
• When administered to girls with Turner syndrome, as they have an increased risk of ear infections. Regular ear examinations are therefore recommended.
• If your child has ever had a cancer or another kind of tumour.
• If your child has replacement therapy with glucocorticoids, you should consult his or her doctor regularly, as your child may need adjustment of the glucocorticoid dose.
• In rare cases Norditropin ® may cause inflammation of the pancreas, which causes severe pain in the abdomen and back. Contact your doctor if your child develops sever stomach-ache after taking Norditropin ® .
• Children treated with Norditropin ® should be regularly assessed by a specialist in child growth. Norditropin ® treatment should always be investigated by a medical practitioner with special knowledge of growth hormone insufficiency and its treatment.

Other medicines and Norditropin ®

Always tell your healthcare professional if your child is taking any other medicine. (This includes complementary or traditional medicines.)

Inform your doctor if your child is taking or has recently taken any of the following medicines:

• glucocorticoids (used to treat inflammation and supress the immune system)
• thyroid hormone (used to treat an underactive thyroid)
• gonadotropin (gonad stimulating hormone)
• anabolic steroids (used to help grow and repair muscle tissues)
• oestrogen taken orally or other sex hormones
• cyclosporine (used after transplant surgery)
• anticonvulsants (used to treat seizures (fits)
• insulin (used to treat diabetes and to help one’s body control blood sugar levels)

Your child’s doctor may need to adjust the dose of Norditropin ® or of the other medicines.

Pregnancy, breastfeeding and fertility

If your child is pregnant or breastfeeding her baby, think she may be pregnant or is planning to have a baby, please consult her doctor, pharmacist or other health care provider for advice before using Norditropin ® . Your child should not use Norditropin ® if she is pregnant or breastfeeding.

Driving and using machines

Norditropin ® does not affect the use of any machines or the ability to drive safely.

Do not share medicines prescribed for your child with any other person. Your child should always take Norditropin ® exactly as his or her doctor has instructed. You should check with your child’s doctor or pharmacist if you are unsure.

Your child’s doctor will tell you how much Norditropin ® your child should receive. In children the dose depends on the body weight or body surface area. It should always be adjusted according to the individual’s response to therapy.

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.

Turner syndrome

The usual dose is 0,045 to 0,067 mg per kg body weight per day.

Your child’s doctor will tell you how long treatment with Norditropin ® will last. Do not stop treatment early without discussing it with your child’s doctor first.

If you have the impression that the effect of Norditropin ® is too strong or too weak, tell your child’s doctor or pharmacist.

When to use Norditropin ®

Inject your child’s daily dose into the skin every evening just before bedtime.

How to use Norditropin ®

Norditropin ® solution comes in a multidose disposable 1,5 mL pre-filled pen. Detailed instructions for use are included in the ‘Instructions on how to use’. The instructional key points are as follows:

• Check the solution before use by turning the pen upside down once or twice. Do not use the pen if the solution is cloudy or discoloured
• Norditropin ® is designed to be used with NovoFine ® or NovoTwist ® disposable needles up to a length of 8 mm
• Always use a new needle for each injection
• Vary the area you inject so you do not harm the skin
• To make sure your child gets the proper dose and you do not inject air, check the growth hormone flow (called ‘priming’ the pen) before the first injection from a new Norditropin ® pen. Do not use the pen if a drop of growth hormone solution does not appear at the needle tip
• Do not share your child’s Norditropin ® pen with anyone else.
• Do not exceed the recommended dosage. Always use Norditropin ® exactly as described in this leaflet or as your child’s doctor or pharmacist have told you. Check with your child’s doctor or pharmacist if you are not sure.

If your child uses more Norditropin ® than he/she should

Tell your child’s doctor if you inject too much Norditropin ® . Long-term overdosing can cause abnormal growth and coarsening of facial features. In the event of overdosage, consult your child’s doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If your child forgets to use / missed a dose of Norditropin ®

Use the next dose as usual, at the normal scheduled time. Do not use / receive a double dose to make up for forgotten individual doses.

If your child stops using Norditropin ®

Do not stop the use of Norditropin ® without discussing it with your child’s doctor first. If you have any further questions on the use of Norditropin ® , ask your child’s doctor, pharmacist or nurse.

Norditropin ® can have side effects.

Not all side effects reported for Norditropin ® are included in this leaflet. Should your child’s general health worsen or if your child experiences any untoward effect while using Norditropin ® , please consult your child’s health care provider for advice.

If any of the following happens, stop the use of Norditropin ® and tell your child’s doctor immediately or go to the casualty department at your nearest hospital:

• swelling of hands, feet, ankles, face, eyelids, lips and mouth or throat, which may cause difficulty in swallowing or breathing/wheezing
• rash or itching
• fainting.

These are all very serious side effects. If your child has them, he/she may have had a serious allergic reaction to Norditropin ® . Your child may need urgent medical attention or hospitalisation.

Tell your child’s doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• headache, eyesight problems, feeling sick (nausea) and being sick (vomiting). These may be signs of raised pressure in the brain
• leukaemia (signs of recurrent infections or fever).

These are all serious side effects. Your child may need urgent medical attention.

Tell your child’s doctor if you notice any of the following:

Less frequent

• headache
• redness, itching and pain in the area of injection
• muscle and joint pain
• swollen hands and feet due to fluid retention
• breast enlargement (gynaecomastia)

Frequency unknown

• underactive thyroid (decreased levels of serum thyroxin)
• high blood sugar levels
• Legg-Calvé-Perthes disease (hip or knee pain which can cause limping)
• increased levels of liver enzymes (blood alkaline phosphatase levels) when tests are done.

In children with Turner syndrome, cases of increased growth of hands and feet compared to height have been observed. Norditropin ® can increase the risk of getting ear infections in children with Turner Syndrome. If you notice any side effects not mentioned in this leaflet, please inform your child’s doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website or by e-mail: [email protected] or telephone 010 500 8699 (toll free). By reporting side effects, you can help provide more information on the safety of Norditropin ® .

Store all medicines out of reach of children.

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

Before opening:

• Store unused pens in a refrigerator (2 ˚ C to 8 ˚ C) in the outer carton, in order to protect from light.
• Do not freeze or expose to heat. Do not store close to any cooling element.

During use:

• After first use, Norditropin ® may be kept up to a maximum of 28 days at 2 ˚ C to 8 ˚ C (in a refrigerator), alternatively
• Norditropin ® 5 mg and 10 mg may be stored at or below 25 ˚ C for a maximum of 21 days.
• Always keep Norditropin ® 15 mg up to a maximum of 28 days at 2 ˚ C to 8 ˚ C (in a refrigerator) after first use.

Do not use Norditropin ® which has been frozen or exposed to excessive temperatures. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).