Norditropin Simplexx 10mg/1.5ml

Norditropin Simplexx 10mg/1.5ml

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Description

Package leaflet: Information for the user

Norditropin SimpleXx 10 mg/1.5 ml solution for injection in cartridge

somatropin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again
If you have any further questions, ask your doctor or pharmacist
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet

1. What Norditropin SimpleXx is and what it is used for
2. What you need to know before you use Norditropin SimpleXx
3. How to use Norditropin SimpleXx
4. Possible side effects
5. How to store Norditropin SimpleXx
6. Contents of the pack and other information

1. What Norditropin Simplexx 10mg/1.5ml is and what it is used for

Norditropin Simplexx 10mg/1.5ml 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 Simplexx 10mg/1.5ml comes as a solution in a cartridge ready for you to inject after you have put it in the matching NordiPen injection pen.

Norditropin SimpleXx 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).
Norditropin SimpleXx is used as a growth hormone replacement in adults:

In adults Norditropin SimpleXx 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.

2. What you need to know before you use Norditropin SimpleXx

Do not use Norditropin SimpleXx

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 tumour (cancer). Tumours must be inactive and you must have finished your antitumour treatment before you start your treatment with Norditropin SimpleXx
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.
Warnings and precautions

Talk to your doctor or pharmacist before using Norditropin SimpleXx

If you have diabetes
If you have ever had a cancer or another kind of tumour
If you have recurrent headaches, eyesight problems, nausea or if vomiting occurs
If you have abnormal thyroid function
An increase in sideways curvature of the spine (scoliosis) may progress in any child during rapid growth. During treatment with Norditropin SimpleXx, your doctor will check you (or your child) for signs of scoliosis
If you walk with a limp or if you start to limp during your growth hormone treatment, you should inform your doctor
If you are over 60 years of age, or have received somatropin treatment as an adult for more than 5 years, as experience is limited
If you suffer from kidney disease, as your kidney function should be monitored by your physician
If you have a replacement therapy with glucocorticoids, you should consult your doctor regularly, as you may need adjustment of your glucocorticoid dose.
Other medicines and Norditropin SimpleXx

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, inform 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 SimpleXx or of the other medicines:

Glucocorticoids – your adult height may be affected if you use Norditropin SimpleXx and glucocorticoids at the same time
Cyclosporine (immunosuppressive) – 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 (gonad stimulating hormone) – as your dose may need to be adjusted
Anticonvulsants – as your dose may need to be adjusted
Oestrogen taken orally or other sex hormones.
Pregnancy and breast-feeding

Somatropin containing products are not recommended in women of childbearing potential not using contraception.

Pregnancy – Stop the treatment and tell your doctor if you become pregnant while you are using Norditropin SimpleXx
Breast-feeding – Do not use Norditropin SimpleXx while you are breast-feeding as somatropin might pass into your milk.
Driving and using machines

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

3. How to use Norditropin SimpleXx

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose

The dose for children depends on their body weight and body surface area. Later in life, the dose depends on 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)
Children with Noonan syndrome:
The usual dose is 0.066 mg per kg body weight per day, however your doctor may decide that 0.033 mg per kg body weight per day is sufficient
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. The 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 on the right dose. The usual maximum dose is 1.0 mg per day.
When to use Norditropin SimpleXx

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

 

How to use Norditropin

Norditropin Simplexx 10mg/1.5ml solution comes in cartridges with a colour-coded cap and is ready to be used in the matching colour-coded NordiPen. If the corresponding NordiPen is not used it will result in incorrect dosing. The NordiPen instruction manual tells you how to use the cartridges in the injection pen
Check each new Norditropin cartridge before you use it. Do not use any cartridge that is damaged or cracked
Do not use the Norditropin cartridges if the solution inside is cloudy or discoloured
Vary the area you inject so you do not harm your skin
Do not share your Norditropin cartridge with anyone else.
How long you will need treatment for

Children with growth failure because of Turner syndrome, kidney disease, SGA or Noonan syndrome: Your doctor will recommend you continue treatment until you stop growing
Children or adolescents who lack growth hormone: Your doctor will recommend you continue treatment into adulthood
Do not stop using Norditropin without discussing it with your doctor first.

If you use more Norditropin than you should

Tell your doctor if you inject too much somatropin. Long-term overdosing can cause abnormal growth and coarsening of facial features.

If you forget to use Norditropin

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

If you stop using Norditropin Simplexx 10mg/1.5ml

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

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

4. 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 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
Hyperglycemia (elevated levels of blood glucose).http://konozahealthbiotech.com

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