Genotropin 12 mg. 36 IU

WHAT Genotropin AND WHAT IT IS USED FOR?
Genotropin is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone which is needed for the growth of bones and muscles. It also helps fat and muscle tissue to develop in the right amounts. That is a recombinant means that it is not made of tissue from human or animal origin.
In children, Genotropin is used to treat the following growth disorders:
• if your growth does not flow properly and your body does not produce enough of its own growth hormone;
• If you have Turner syndrome. Turner syndrome is a chromosomal abnormality in girls that can affect growth - your doctor should have told you if you have this syndrome;
• If you have chronic renal failure. When the kidneys lose their ability to function normally this can affect growth;
• if you suffer from Prader-Willi syndrome (a chromosomal disorder). Growth hormone will help you increase your height, if you still continue to grow and improve your body structure. Excess fat will decrease and your reduced muscle mass will increase.
• if you were born small or too light weight. Growth hormone can help you reach higher growth if you did not catch up growth or maintain normal growth by the fourth year or thereafter.
In adults, Genotropin is used to treat people with pronounced growth hormone deficiency. It may have occurred in adulthood or continue from childhood.
If you have been treated with Genotropin for growth hormone deficiency during childhood, the condition of your growth hormone will be checked again after the age of growth. Your doctor will propose continuation of Genotropin treatment, if confirmed severe growth hormone deficiency.
This medicine should only be given by a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis.

2. BEFORE YOU USE Genotropin
Do not use Genotropin if:
- Are allergic (hypersensitive) to somatropin or any of the other ingredients of Genotropin.
- You have an active tumor (cancer). Tumours must be inactive and you must have completed your anti-tumor treatment before you start using Genotropin.
- You are seriously ill (for example, you have complications after open heart surgery, abdominal surgery, acute respiratory failure, trauma from an accident or a similar condition). If you are or have been undergoing major surgery or for some reason you go into hospital, report it to your doctor and remind other doctors you visit that you are being treated with growth hormone. Genotropin has been prescribed to stimulate growth but you have already stopped growing (closed epiphyses).

Take special care with Genotropin
If there is a risk to develop diabetes, your doctor will want to monitor your blood sugar during treatment with Genotropin;
If you have diabetes should closely monitor the level of your blood sugar level during treatment with Genotropin and check the results with your doctor to determine whether it is necessary to change the dose of your diabetes medicines; Once you start treatment with Genotropin, some patients may need to start thyroid replacement therapy.
If you are treated with thyroid hormones may be necessary to change the dose of thyroid hormone.
Limp or if you start to limp during your growth hormone treatment, tell your doctor;
If you have raised intracranial pressure (which causes symptoms such as severe headache, visual disturbances or vomiting) you should inform your doctor about it;
If your doctor has confirmed that you received an inflammation of the muscles near the injection site because of the preservative metacresol, you should use medicine without metacresol;
If you are treated with Genotropin for growth hormone deficiency after previous tumor (cancer). You should be regularly examined for tumor recurrence; Experience in patients over 80 years is limited. Elderly people may be more sensitive to the effects of Genotropin, and therefore may be more prone to develop adverse reactions.

Children with chronic renal failure:
Your doctor should check your kidney function and your growth rate before starting Genotropin. Medical treatment for your kidney condition should be continued. Genotropin treatment should be stopped at kidney transplantation.

Children with Prader-Willi syndrome:
Your doctor will prescribe dietary restrictions to control your weight, your doctor will examine you for signs of obstruction of the upper airways, apnea during sleep (when you interrupted breathing during sleep), or respiratory infection before starting treatment with Genotropin.
If during treatment show signs of obstruction of the upper respiratory tract (including the occurrence of snoring or worsening of snoring), will be necessary for your doctor to examine you and may terminate your treatment with Genotropin. During treatment, your doctor will check for signs of scoliosis - a type of spinal curvature.
If during treatment develop respiratory infection, tell your doctor so that he can treat the infection.

Children born small or too light weight:
If you were born small or too light weight and you are between 9 and 12 years, ask your doctor for specific advice in relation to puberty and treatment with this product.
Your doctor will check your blood sugar and insulin levels before the start of treatment and every year during treatment. Treatment should continue until you stop your growth.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor if you use: medicines to treat diabetes; thyroid hormones; synthetic adrenal hormones (corticosteroids); sex hormones (e.g., estrogens); ciclosporin (a medicine that targets a weakened immune system after tranplantatsiya);
• medicines to control epilepsy (anticonvulsants).
You may need your doctor to adjust the dose of these medicines or the dose of Genotropin.

Pregnancy and lactation
You should not use Genotropin if you are pregnant or trying to get pregnant. Ask your doctor before taking this medicine if you are breastfeeding. Ask your doctor or pharmacist before taking any medicine.

Important information about some of the ingredients of Genotropin
This product contains less than 1 mmol sodium (23 mg) per dose, ie practically without sodium.

3. HOW TO USE Genotropin?
recommended dosage
The dose depends on your height, the disease for which you are being treated and how well growth hormone in you. Each patient is different from the others. Your doctor will determine your individual dose of Genotropin in milligrams (mg) according to your body weight in kilograms (kg) or according to your body surface area, calculated according to your height and weight in square meters (py), and will clear your schedule . Do not change the dosage and treatment schedule without first consulting your doctor. Children with growth hormone deficiency 0,025 - 0,035 mg / kg body weight per day, or 0,7 - 1,0 mg / m2 of body surface area per day may be used at higher doses. When growth hormone deficiency continues into adolescence, Genotropin should be continued until completion of physical development.

Children with Turner syndrome:
0,045 - 0,050 mg / kg body weight per day or 1,4 mg / m2 of body surface area per day.
Children with chronic renal failure:
0,045 - 0,050 mg / kg body weight per day or 1,4 mg / m2 of body surface area per day. May require higher doses, if the growth rate is too slow. Dose adjustments may be necessary after 6 months of treatment.

Children with Prader-Willi syndrome:
0,035 mg / kg body weight per day or 1,0 mg / m2 of body surface area per day. The daily dose should not exceed 2,7 mg. Treatment should not be used in children, where growth is almost stopped after puberty.

Children born smaller or lighter weight than expected, and growth disorders: 0,035 mg / kg body weight per day or 1,0 mg / m2 of body surface area per day. It is important to continue treatment until final height. Treatment should be discontinued after the first year in the absence of effect or if you have reached your final height and you have stopped growing.

Adults with growth hormone deficiency:
If you continue to use Genotropin after treatment during childhood you should start with 0,2 - 0,5 mg per day. This dose should be gradually increased or decreased according to blood test results as well as clinical response and side effects.

If GH deficiency started in adulthood should start with 0,15 -0,3 mg per day. This dose should be gradually increased or decreased according to blood test results as well as clinical response and side effects. The daily maintenance dose seldom exceeds 1,0 mg per day. In women may require application of higher doses than men. The dose should be monitored every 6 months. Persons above 60 years should start with a dose of 0,1 - 0,2 mg per day which should be slowly increased according to individual needs. Must use the minimum effective dose. The daily maintenance dose seldom exceeds 0,5 mg per day. Follow your doctor's instructions.
Injecting Genotropin
Genotropin is intended for subcutaneous administration. This means that it is injected through a short needle into the fatty tissue just beneath the skin. Your doctor should have already shown you how to use Genotropin. Always use Genotropin exactly as your doctor tells you. If you are not sure ask your doctor or pharmacist to show you.
When using the pen (pen), the needle must be inserted before the dissolution. Detailed instructions for use are applied in medical devices (pens) also.
• Preparing the injection:
It is recommended to remove the growth hormone from the refrigerator half an hour before the injection. Dual-chamber cartridge contains both growth hormone and solvent, and is intended for use with a special injection device (pen) - Genotropin Pen (Genotropin Pen). Growth hormone and the solvent in the dual-chamber cartridge can be mixed together using the device Genotropin Pen (Genotropin Pen) Dissolve the powder by gently tilting forward - backward Genotropin Pen (Genotropin Pen) about 5-10 times until the powder is dissolved.
When mixing the growth hormone solvent Do not shake the solution. Use light circular movements. Vigorous stirring of the solution can lead to the formation of foam and damage the active substance. Check the solution and do not use it if it is cloudy or has particles in it.
• Injecting Genotropin:
Remember to wash your hands and clean the skin at the injection site before treatment.
Inject your growth hormone at about the same time each day. Time bedtime is suitable because it is easy to remember. Normally also have higher levels of growth hormone at night.
Most people make the injection into the thigh or buttocks. Do your injection in the place indicated by your doctor. Adipose tissue of the skin can shrink at the site of application. To avoid this, each time using slightly different injection site. This gives your skin and subcutaneous tissue time to recover from the previous injection, before another injection in the same place.
Do not forget to return Genotropin back in the refrigerator immediately after the injection.

If you use more than the amount of Genotropin
If you inject much more than the required amount, you must report it immediately to your doctor or pharmacist. Your blood sugar may drop to too low, and later to become too high. It is possible to get tremors, sweating, drowsiness or feel "delirious" and faint.

If you forget to use Genotropin
Do not take a double dose to make up the missed dose.
It is best to apply your regular growth hormone. If you miss a dose the next injection at the usual time the next day. Write down every missed shot and tell about it to your doctor at the next checkup.

If you stop using Genotropin
Ask your doctor before you stop using Genotropin.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Genotropin can cause side effects, although not everybody gets them.
Common side effects (likely to occur in less than 1 in 10 patients) include:
Formation of antibodies to the injected GH, but this does not appear to interfere with the effect of growth hormone.
In children:
• temporary redness, itching or pain at the injection site
In adults:
• numbness / tingling;
• stiffness in the arms and legs, joint pain, muscle pain;
• Water retention (which manifests as puffy fingers or swollen ankles, for a short time at the beginning of treatment). These symptoms may occur early in treatment, but disappear spontaneously or with dose reduction.
These common side effects in adults may occur during the first months of treatment and may disappear spontaneously or if your dose is reduced.
Uncommon side effects (likely to occur in less or 1 in 100 patients) include: In children:
• numbness / tingling;
• stiffness in the arms and legs, joint pain, muscle pain;
• Water retention (which manifests as puffy fingers or swollen ankles, for a short time at the beginning of treatment).
In adults:
• pain or burning sensation in the hands or forearms (known as Canalis Carpi syndrome).
Rare side effects (likely to occur in less than 1 in 1000 patients) include:
• type 2 diabetes mellitus;
• Increased intracranial pressure (which causes symptoms such as severe headache, visual disturbances or vomiting).
Very rare side effects (likely to occur in less than 1 in 10,000 patients) include:
• leukemia.
The skin around the injection site can become rough or lumpy, but this will not happen if you inject each time in a different place.
A very rare side effect that may occur due to the presence of the preservative m-cresol, is an inflammation of the muscles around the injection site. If your doctor confirms that you have received such a reaction, you can use the product without metacresol.
There have been rare cases of sudden death in patients with Prader-Willi syndrome. Has not been established, however, a connection between these cases and treatment with Genotropin.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE Genotropin?
Keep out of reach of children.
Do not use Genotropin after the expiry date stated on the pack expiry date refers to the last day of that month.
Before mixing the powder with the solvent, your growth hormone must be stored in a refrigerator (2 ° C to 8 ° C) through the expiration date. During this period may keep it below 25 ° C (unrefrigerated) up to 1 month maximum, but then must be discarded.
Genotropin is sensitive to light. You should keep dual-chamber cartridge in the outer carton in order to protect your Genotropin from light.
After mixing the powder and solvent Genotropin must be stored in a refrigerator (2 ° C to 8 ° C) up to 4 weeks in the outer carton to protect from light.
Do not freeze and do not expose Genotropin to frost. Do not use if frozen.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
Never dispose of needles or partly used or empty cartridges with household waste. After using a needle, throw it away carefully so that no one can see it, uses or speared her. You can take a special sharps container from a hospital or clinic.
These measures will help to protect the environment.

6. FURTHER INFORMATION
What Genotropin?
The active substance is recombinant somatropin. Each cartridge contains 12 mg somatropin.
After mixing of the powder and the solvent to give 1 ml of solution for injection. The other ingredients in the powder are: glycine (E640), mannitol (E421), anhydrous sodium dihydrogen phosphate (E339) and anhydrous disodium phosphate (E339). The ingredients in the solvent are water for injection, mannitol (E421) and metacresol.

Genotropin looks like and contents of the pack?
Your medicine is located in a cartridge consisting of two parts. Goy is intended to be placed in a special injection system (pen) called Genotropin Pen 12 / Genotropin Pen 12. In front of the cartridge containing growth hormone, together with excipients in powder form, and the rear portion is the solvent.
Each pack contains a two-chamber cartridge.
Instructions for use of the device - injection system (pen) Genotropin Pen / Genotropin Pen are applied in its packaging. You should ask your doctor about the pen, if you do.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Pfizer