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Omnitrope HGH 10 mg/1,5 ml. 1 injection solution

€388
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Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone, which is needed for bone and muscle growth. It also helps develop fat and muscle tissue in the right proportion. Being recombinant means that it is not made from human or animal tissue.

Quantity

1. What Omnitrope is and what it is used for

Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone, which is needed for bone and muscle growth. It also helps fat and muscle develop in the right proportion. Being recombinant means that it is not made from human or animal tissue.

In children, Omnitrope is used to treat the following growth disorders:

If you are not growing properly and do not have enough of your own growth hormone.

If you have Turner syndrome. Turner syndrome is a genetic disorder in girls that can affect growth - your doctor should have told you if you have this condition.

If you have chronic kidney failure. When the kidneys lose their ability to function normally, this can affect growth.

If you were born very short or underweight. Growth hormone can help you grow taller if you have not been able to catch up or maintain normal growth by the age of 4 or later.

If you have Prader-Willi syndrome (PWS) (a chromosomal disorder). Growth hormone will help you grow taller if you are still growing and will also improve your body structure. Your excess fat will be reduced and your reduced muscle mass will be improved.

In adults, Omnitrope is used to treat people with a pronounced growth hormone deficiency. This may have appeared in adulthood or have been present since childhood.

If you were treated with Omnitrope for growth hormone deficiency as a child, your growth hormone status will be checked again after your growth has stopped. If severe growth hormone deficiency is confirmed, your doctor will suggest continuing treatment with Omnitrope.

This medicine should only be given to you by a doctor who is experienced in the use of growth hormone therapy and who has confirmed your diagnosis.

2. What you need to know before you use Omnitrope

Do not use Omnitrope

if you are allergic (hypersensitive) to somatropin or any of the other ingredients of Omnitrope.

and tell your doctor if you have an active tumour (cancer). The tumours must be inactive and your anti-cancer treatment must be completed before you start treatment with Omnitrope.

and tell your doctor if you have already been prescribed Omnitrope to stimulate growth but you have already stopped growing (closed epiphyses).

if you are seriously ill (for example complications after open heart surgery, abdominal surgery, accidental trauma, acute respiratory failure or similar conditions). If you are due to have or have had major surgery or are admitted to hospital for any reason, tell your doctor and remind any other doctors you see that you are using growth hormone.

Warnings and precautions

Talk to your doctor before using Omnitrope.

If you are receiving glucocorticoid replacement therapy, you should consult your doctor regularly, as your glucocorticoid dose may need to be adjusted.

If you are at risk of developing diabetes, your doctor will monitor your blood glucose levels during somatropin therapy.

If you have diabetes, you should monitor your blood sugar levels carefully during somatropin treatment and discuss the results with your doctor to see if the dose of your diabetes medication needs to be adjusted.

After starting somatropin treatment, some patients may require thyroid hormone replacement therapy.

If you are receiving thyroid hormone treatment, your thyroid hormone dose may need to be adjusted.

If you have increased intracranial pressure (leading to symptoms such as severe headache, visual disturbances, nausea or vomiting), you should inform your doctor.

If you limp when walking or if you develop a limp during treatment with growth hormone, you should inform your doctor.

If you are receiving somatropin for growth hormone deficiency after a previous tumor (cancer), you should be monitored regularly for a recurrence of the tumor or for any other cancer.

If you have worsening abdominal pain, you should inform your doctor.

Experience in patients over 80 years of age is limited. Elderly patients may be more sensitive to the effects of somatropin and may therefore be more likely to develop side effects. Omnitrope may cause inflammation of the pancreas, which causes severe abdominal and back pain. Contact your doctor if you develop (or your child develops) stomach pain after taking Omnitrope.

As the child grows rapidly, a sideways curvature of the spine (scoliosis) may progress.

During treatment with somatropin, your doctor will check whether you (or your child) have symptoms of scoliosis.

Children with chronic renal failure

Your doctor should check your kidney function and growth rate before starting treatment with somatropin. Your kidney treatment should be continued. Somatropin treatment should be stopped if you have a kidney transplant.

Children with Prader-Willi syndrome

Your doctor will prescribe dietary restrictions to control your weight.

Your doctor will examine you for signs of upper airway obstruction, sleep apnoea (stopping breathing during sleep) or respiratory tract infection before starting treatment with somatropin.

Tell your doctor if you develop signs of upper airway obstruction (including new or worsening snoring) during treatment with somatropin. Your doctor will need to examine you and may stop your treatment with somatropin.

During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity.

If you develop a lung infection during treatment, tell your doctor so that he or she can treat the infection.

Children born too short or underweight

If you were born too short or underweight and are between 9 and 12 years of age, ask your doctor for specific advice about puberty and treatment with this medicine.

Treatment should continue until your growth has stopped.

Your doctor will check your blood sugar and insulin levels before starting treatment and every year during treatment.

Other medicines and Omnitrope

You should 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 Omnitrope or other medicines:

medicines to treat diabetes, thyroid hormones,

medicines to control epilepsy (anticonvulsants), ciclosporin (a medicine that weakens the immune system after transplants), oestrogen taken by mouth or other sex hormones, synthetic adrenal hormones (corticosteroids).

Your doctor may need to adjust the dose of these medicines or the dose of somatropin.

Pregnancy and breast-feeding

You should not use Omnitrope if you are pregnant or trying to become pregnant.

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding, as large amounts of benzyl alcohol may build up in your body and may cause a side effect (called “metabolic acidosis”).

Important information about some of the ingredients of Omnitrope

This medicine contains sodium, less than 1 mmol (23 mg) per ml, i.e. essentially sodium-free.

Omnitrope 5 mg/1.5 ml solution for injection:

This medicine contains 9 mg benzyl alcohol in each ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol is associated with a risk of serious side effects, including breathing problems (called “asphyxiation syndrome”) in young children.

Do not use in newborn babies (up to 4 weeks of age) unless advised by your doctor.

Ask your doctor or pharmacist for advice if you have kidney or liver disease, as large amounts of benzyl alcohol may build up in your body and may cause a side effect (called “metabolic acidosis”).

Due to the presence of benzyl alcohol, the medicinal product should not be used in premature babies or newborns. It may cause toxic reactions and allergic reactions in infants and children up to 3 years of age.

Do not use for more than one week in young children (under 3 years of age) unless advised by your doctor or pharmacist.

3. How to use Omnitrope

Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, ask your doctor, pharmacist or nurse.

The dose depends on your height, the condition you are being treated for and how well you respond to growth hormone. Everyone is different. Your doctor will advise you on your individual dose of Omnitrope in milligrams (mg) based on your body weight in kilograms (kg) or your body surface area calculated from your height and weight in square metres (m2), and on your treatment regimen. Do not change your dosage and treatment regimen without consulting your doctor.

The recommended dose is:

Children with growth hormone deficiency:

0.025-0.035 mg/kg body weight per day or 0.7-1.0 mg/m2 body surface area per day. Higher doses may be used. If growth hormone deficiency persists into adolescence, Omnitrope should be administered until physical development is complete.

Children with Turner syndrome:

0.045-0.050 mg/kg body weight per day or 1.4 mg/m2 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 body surface area per day. Higher doses may be necessary if growth rate is low. Dose adjustment 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 body surface area per day. The daily dose should not exceed 2.7 mg. Treatment should not be given to children who have almost stopped growing after puberty.

Children born shorter or heavier than expected and with growth failure:

0.035 mg/kg body weight per day or 1.0 mg/m2 body surface area per day. It is important to continue treatment until final height is reached. Treatment should be stopped after the first year if there is no response or if you have reached your final height and have stopped growing.

Adults with growth hormone deficiency:

If you are continuing Omnitrope after having been treated in childhood, you should start with 0.2-0.5 mg per day.

This dosage should be gradually increased or decreased depending on the results of blood tests, as well as on the clinical response and side effects.

If your growth hormone deficiency has developed after reaching adulthood, you should start with 0.15-0.3 mg per day. This dosage should be increased gradually depending on blood sugar levels, as well as on the clinical response and side effects. The daily maintenance dose rarely exceeds 1.0 mg per day. Women may need higher doses than men. The dosage should be monitored every 6 months. People over 60 years of age should start with a dose of 0.1-0.2 mg per day, and this should be slowly increased according to individual needs. The minimum effective dose should be used. The maintenance dose is rarely higher than 0.5 mg per day. Follow the instructions given to you by your doctor.

Injecting Omnitrope

Inject your growth hormone at about the same time each day. The best time is before going to bed as it is easy to remember. It is also natural to have higher levels of growth hormone at night.

Omnitrope 5 mg/1.5 ml is intended for multiple administration. The administration should only be done with the Omnitrope Pen 5, a specially designed injection device for use with Omnitrope 5 mg/1.5 ml solution for injection.

Omnitrope 10 mg/1.5 ml is intended for multiple administration. The administration should only be done with the Omnitrope Pen 10, a specially designed injection device for use with Omnitrope 10 mg/1.5 ml solution for injection.

Omnitrope is intended for subcutaneous administration. This means that it will be injected through a short injection needle into the fatty tissue under the skin. Most people give their injections in their thigh or buttock. Give your injections in the place shown to you by your doctor. The fatty tissue of the skin may contract at the injection site. To avoid this, use a slightly different injection site each time. This gives your skin and the tissue under the skin time to recover from one injection before receiving another injection in the same place.

Your doctor should have already shown you how to use Omnitrope. Always inject Omnitrope exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

How to inject Omnitrope

The following instructions explain how to inject Omnitrope. Please read the instructions carefully and follow them step by step. Your doctor or nurse will show you how to inject Omnitrope. Do not attempt to inject unless you are sure that you understand the procedure and requirements for the injection.

Omnitrope is given by injection under the skin

Look carefully at the solution before injecting and only use it if it is clear and colourless.

Rotate the injection site to minimize the risk of local lipoatrophy (local reduction of fatty tissue under the skin).

Preparation

Get the necessary supplies ready before you begin:

cartridge of Omnitrope solution for injection.

Omnitrope Pen, a specially designed injection device for administering Omnitrope solution for injection (not supplied with the pack; see Instructions for Use of Omnitrope Pen).

pen needle for subcutaneous injection (not supplied with the pack).

2 cleansing swabs (not supplied with the pack).

Wash your hands before continuing with the next steps.

Injecting Omnitrope

Use a cleaning swab to disinfect the rubber membrane of the cartridge.

The contents should be clear and colourless.

Insert the cartridge into the injection pen. Follow the instructions for use of the injection pen. To set the pen, dial the required dose.

Choose an injection site. The best injection sites are areas with a layer of fat between the skin and the muscle, such as the thigh or abdomen (excluding the navel or waist).

Make sure you give the injection at least 1 cm from the last injection site, and that you rotate injection sites as you have been trained.

Before giving the injection, clean the skin with an alcohol swab. Wait for the site to dry.

Insert the needle into the skin as shown by your doctor.

After the injection

After the injection, apply pressure to the injection site with a small bandage or sterile gauze for a few seconds.

Do not massage the injection site.

Remove the needle from the pen using the needle cap and discard the needle. This will keep the Omnitrope solution sterile and prevent leakage. It will also stop air from entering the pen and clogging the needles. Do not share your pen with anyone else. Do not share your needles with anyone else.

Leave the cartridge in the pen, replace the pen cap and store in the refrigerator.

The solution should be clear when taken out of the refrigerator. Do not use if the solution is cloudy or contains particles.

If you use more Omnitrope than you should

If you have injected significantly more than you should, contact your doctor or pharmacist as soon as possible. Your blood sugar may drop too low and then rise too high. You may shake, sweat, feel sleepy or dizzy, or faint.

If you forget to use Omnitrope

Do not take a double dose to make up for a forgotten dose. It is best to use growth hormone regularly. If you forget to take a dose, have your next injection at the usual time the next day. Record any missed doses and tell your doctor about them at your next check-up.

If you stop using Omnitrope

Ask your doctor for advice before stopping using Omnitrope.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The very common and common side effects in adults may start within the first few months of treatment and may either stop spontaneously or when the dose is reduced.

Very common side effects (may affect more than 1 in 10 people) include:

Joint pain

Water retention (seen as swollen fingers or ankles for a short time after starting treatment)

Redness, itching or pain at the injection site

Common side effects (may affect up to 1 in 10 people) include:

Raised, itchy bumps on the skin

Rash

Tingling/tingling

Stiffness of the hands and feet, muscle pain

In adults

Pain or burning sensation in the hands or forearms (known as carpal tunnel syndrome)

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

Breast enlargement (gynaecomastia)

Itching

Rare side effects (may affect up to 1 in 1,000 people) include:

In children

Leukaemia (this has been reported in a small number of patients with growth hormone deficiency, some of whom were treated with somatropin. However, there is no evidence that the incidence of leukaemia is increased in people receiving growth hormone who do not have predisposing factors.)

Increased intracranial pressure (leading to symptoms such as severe headache, visual disturbances or vomiting)

Not known (frequency cannot be estimated from the available data):

Type 2 diabetes

Decreased levels of the hormone cortisol in your blood

Swelling of the face

Headache

Hypothyroidism

In adults

Increased intracranial pressure (leading to symptoms such as severe headache, visual disturbances or vomiting)

Formation of antibodies to the injected growth hormone, but these do not appear to stop the growth hormone from working.

The skin around the injection site may become rough and lumpy, but this should not happen if you change the injection site each time.

Rare cases of sudden death have been observed in patients with Prader-Willi syndrome. However, no association has been established between these cases and treatment with Omnitrope.

If you experience discomfort or pain in your hip or knee during treatment with Omnitrope, your doctor may consider the possibility of slipped capital femoral epiphysis and Legg-Calve-Perthes disease.

Other possible side effects, such as

related to your growth hormone treatment may include the following:

You (or your child) may develop high blood sugar or low thyroid hormone levels. Your doctor may check this and, if necessary, prescribe appropriate treatment. Inflammation of the pancreas has been reported rarely in patients treated with growth hormone.

5. How to store Omnitrope

Keep out of the reach and sight of children.

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

Store and transport in a refrigerator (2°C-8°C).

Do not freeze.

Store in the original package in order to protect from light.

After the first injection, the cartridge should remain in the injection pen and should be stored in a refrigerator (2°C-8°C) and used for a maximum of 28 days.

Do not use Omnitrope if you notice that the solution is cloudy.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Omnitrope 5 mg/1.5 ml contains

The active substance of Omnitrope: somatropin.

Each ml of solution contains 3.3 mg somatropin (corresponding to 10 IU).

One cartridge contains 5.0 mg (corresponding to 15 IU) somatropin in 1.5 ml.

The other ingredients are:

Disodium hydrogen phosphate heptahydrate

Sodium dihydrogen phosphate dihydrate

Mannitol

Poloxamer 188

Benzyl alcohol

Water for injections

What Omnitrope 10 mg/1.5 ml contains

The active substance of Omnitrope: somatropin.

Each ml of solution contains 6.7 mg somatropin (corresponding to 20 IU).

One cartridge contains 10.0 mg (corresponding to 30 IU) somatropin in 1.5 ml.

Other ingredients:

disodium hydrogen phosphate heptahydrate

sodium dihydrogen phosphate

glycine dihydrate

poloxamer 188 phenol

water for injections

What Omnitrope looks like and contents of the pack

Omnitrope is a clear and colourless solution for injection.

Packs of 1, 5 and 10.

Not all pack sizes may be marketed.

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