5 mg / 1.5 ml, 10 mg / 1.5 ml, 15 mg / 1.5 ml solution for injection in cartridge somatropin
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 the natural human growth hormone needed for bones and muscles to grow. It also contributes to the development of fat and muscle tissue in the right amounts. It is recombinant, meaning 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 enough because you 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 has told you if you have this syndrome.
- If you have chronic kidney disease. Growth can be affected when the kidneys lose their ability to function normally.
- If you were short or weighed too little at birth. Growth hormone can help you grow longer if you have not caught up or reached normal growth at 4 years of age or later.
- If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone helps you grow longer if you are still growing and will also improve your body composition. Excess fat will decrease and muscle mass will increase.
In adults, Omnitrope is used to
- treat people with severe growth hormone deficiency. This may occur in adulthood or have begun in childhood.If you have been treated with Omnitrope for growth hormone deficiency during childhood, the amount of growth hormone in your body will be tested again after you have stopped growing. If it turns out that you have a severe growth hormone deficiency, your doctor will suggest that you continue treatment with Omnitrope.
You should only get this medicine from a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis.
What you need to know before you use Omnitrope
Do not use Omnitrope
- if you are allergic (hypersensitive) to somatropin or to any of the other ingredients of Omnitrope.
- and tell your doctor if you have an active tumor (cancer). Tumor one must be inactive and you must have stopped your cancer treatment before starting your treatment with Omnitrope.
- and tell your doctor if you have been prescribed Omnitrope to stimulate growth but you have already stopped growing (closed epiphysis).
- if you are seriously ill (for example, complications due to major heart surgery, abdominal surgery, trauma due to an accident, acute impaired lung function or similar conditions). If you are going to have or have had major surgery or are hospitalized for any reason, tell your doctor and remind the other doctors you meet that you are using growth hormone .
Warnings and cautions
Talk to your doctor before using Omnitrope.
- If you are receiving replacement therapy with glucocorticoids , you should contact your doctor regularly, as you may need to adjust your glucocorticoid dose.
- If you are at risk of developing diabetes . Your doctor will need to check your blood sugar level during treatment with somatropin.
- If you have diabetes , you should check your blood sugar level carefully during treatment with somatropin and discuss the results with your doctor to determine if you need to change the dosage of one of your diabetes medicines.
- After starting somatropin treatment, some patients may need to start treatment with thyroid hormone replacement.
- If you are being treated with thyroid hormones, it may be necessary to adjust your thyroid hormone dose.
- If you have increased intracranial pressure (which causes symptoms such as severe headache, visual disturbances or vomiting), tell your doctor.
- If you limp or start limping during growth hormone treatment , tell your doctor.
- If you are receiving somatropin treatment for growth hormone deficiency after a previous tumor (cancer), you should be examined regularly for the recurrence of one or another cancer.
- If you get worsening abdominal pain, tell your doctor.
- The experience of patients over the age of 80 is limited. Elderly people may be more sensitive to the effects of somatropin and may therefore be at greater risk of developing side effects .
- Omnitrope 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 Omnitrope.
Children with chronic renal impairment
- Your doctor should examine your kidney function and growth rate before starting somatropin. Medical treatment of renal impairment should be continued. Somatropin treatment should be discontinued during kidney transplantation.
Children with Prader-Willi syndrome
- Your doctor will give you dietary restrictions that you should follow to control your weight.
- Your doctor will assess you for signs of obstruction (obstruction) in the upper respiratory tract, sleep apnea (respiratory arrest during sleep) or infection of the lungs or airways before starting treatment with somatropin.
- During treatment with somatropin, tell your doctor if you show signs of upper airway obstruction (for example, if you start snoring or snore more than usual); In this case, your doctor will need to examine you and possibly discontinue somatropin treatment.
- During treatment, your doctor will examine if you show any signs of scoliosis, a type of deformity of the spine.
- If you develop a lung infection during treatment, tell your doctor so that you can receive treatment for infection one.
Children who are born short or weigh too little at birth
- If you were too short or weighed too little at birth and are 9 to 12 years old, ask your doctor for advice on puberty and treatment with this medicine.
- The treatment should continue until you have stopped growing.
- Your doctor will check your blood sugar and insulin levels before starting treatment and every year during treatment.
Other medicines and Omnitrope
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 for diabetes ,
- thyroid hormones,
- medicines to control epilepsy ( antiepileptics ),
- ciclosporin (a medicine that weakens the immune system after transplantation),
- estrogen taken by mouth or other sex hormones
- synthetic adrenal cortex hormones ( corticosteroids ).
Your doctor may need to adjust the dose of one of these medicines or the somatropin dose.
Pregnancy and breastfeeding
You should not use Omnitrope if you are pregnant or trying to become pregnant.
Ask your doctor or pharmacist if you are pregnant or breast-feeding before taking this medicine. The reason is that benzyl alcohol can be stored in the body and cause side effects (called “metabolic acidosis”).
Important information about some of the ingredients of Omnitrope
This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free’.
Omnitrope 5 mg / 1.5 ml solution for injection :
This medicine contains 9 mg of benzyl alcohol per ml.
Benzyl alcohol can cause allergic reactions.
Benzyl alcohol is associated with the risk of serious side effects such as difficulty breathing (called “gasping syndrome”) in young children.
Do not give this medicine to newborns (up to 4 weeks old) unless your doctor tells you to.
Ask your doctor or pharmacist for advice if you have liver or kidney disease before using this medicine. The reason is that large amounts of benzyl alcohol can be stored in the body and cause side effects (called “metabolic acidosis”).
Because the medicine contains benzyl alcohol, it must not be given to infants. It can cause poisoning or allergic reactions in children under 3 years.
Do not use the medicine for more than 1 week in newborns (younger than 3 years) unless recommended by a doctor or pharmacist.
How to use Omnitrope
Always use this medicine exactly as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Dose one depends on how big you are, what condition you are being treated for, and how good the growth hormone effect is on you. All people are different. Your doctor will tell you how many doses of Omnitrope in milligrams (mg) are suitable for you depending on your body weight in kilograms (kg) or your body surface area in square meters (m 2 ), calculated based on your height and weight, and your treatment plan. Do not change the dose or treatment plan 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 / m 2 body surface area per day. Higher doses can be used. If growth hormone deficiency persists during adolescence, treatment with Omnitrope should be continued until physical development is complete.
Children with Turner syndrome:
0.045‑0.050 mg/kg body weight per day or 1.4 mg / m 2 body surface area per day.
Children with chronic renal failure:
0.045‑0.050 mg/kg body weight per day or 1.4 mg / m 2 body surface area per day. Higher doses may be necessary if the growth rate is too low. Dose adjustment may be required after 6 months of treatment.
Children with Prader-Willi syndrome:
0.035 mg / kg body weight per day or 1.0 mg / m 2 body surface area per day. The daily dose should not exceed 2.7 mg. Children who have almost stopped growing after puberty should not be treated.
Children with growth retardation who were shorter or weighed less at birth than expected:
0.035 mg / kg body weight per day or 1.0 mg / m 2 body surface area per day. It is important to continue treatment until the final length has been reached. The treatment should be stopped after the first year if you do not respond to the treatment or if you have reached your final length and have stopped growing.
Adults with growth hormone deficiency:
If you continue to take Omnitrope after treatment during childhood, you should start with 0.2‑0.5 mg per day. This dose should be gradually increased or decreased depending on blood levels and the results of treatment and side effects.
If your growth hormone deficiency occurred in adulthood, you should start with 0.15‑0.3 mg per day. This dose should be gradually increased based on blood test results, clinical response, and side effects. The daily maintenance dose rarely exceeds 1.0 mg per day. Women may need a higher dose of you than men. Dose one should be checked every 6 months. People over the age of 60 should start with a dose of 0.1‑0.2 mg per day, which is slowly increased according to individual needs. The lowest effective dose should be used. The maintenance dose is rarely higher than 0.5 mg per day. Follow your doctor’s instructions.
Injection of Omnitrope
Inject your growth hormone at about the same time each day. Bedtime is a good time because it is easy to remember. It is also natural to have a higher level of growth hormone during the night.
Omnitrope 5 mg / 1.5 ml in a cartridge for SurePal 5 is for reusable use. It should only be administered with SurePal 5, an injection device that has been specially developed for use with Omnitrope 5 mg / 1.5 ml solution for injection.
Omnitrope 10 mg / 1.5 ml in a cartridge for SurePal 10 is for reusable use. It should only be administered with SurePal 10, an injection aid that has been specially developed for use with Omnitrope 10 mg / 1.5 ml solution for injection.
Omnitrope 15 mg / 1.5 ml in a cartridge for SurePal 15 is for reusable use. It should only be administered with SurePal 15, an injection aid that has been specially developed for use with Omnitrope 15 mg / 1.5 ml solution for injection.
Omnitrope is for subcutaneous use. This means that it is injected with a short injection needle into the adipose tissue just under the skin. Most people inject one into the thigh or buttocks. Give injection one at the place your doctor has shown you. The adipose tissue of the skin may shrink at the injection site. To avoid this, move the injection site a little each time. This gives the skin and the area under the skin time to recover from an injection before receiving another 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. Ask your doctor or pharmacist if you are unsure.
How to inject Omnitrope
The following instructions explain how to inject Omnitrope yourself. Read the instructions carefully and follow them step by step. Your doctor or nurse will show you how to inject Omnitrope. Do not try to inject yourself unless you are sure you understand the procedure and requirements for injecting one.
- Omnitrope is given as an injection under the skin.
- Examine the solution carefully before injection. It should only be used if it is clear and uncoloured.
- The injection site should be varied to minimize the risk of localized loss of fat cells under the skin.
If you use more Omnitrope than you should
If you inject too much, contact your doctor or pharmacist as soon as possible. Blood sugar levels may drop or rise too much. You may feel shaky, sweaty, sleepy, or “weird” and you may faint.
If you forget to take Omnitrope
Do not take a double dose to make up for a forgotten dose. It is best if you use growth hormone regularly. If you miss a dose, take the next injection at the usual time the next day. Make a note of any missed dose and inform your doctor at the next check-up.
If you stop using Omnitrope
Talk to your doctor before stopping Omnitrope.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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 can occur within the first few months of treatment and may disappear either spontaneously or if the dose is reduced.
Very common side effects (may affect more than 1 user in 10):
- Joint pain
- Fluid retention (which appears as swollen fingers or ankles for a short time at the start of treatment)
- Redness , itching or pain at the injection site
Common side effects (may affect up to 1 in 10 people):
- Raised, itchy lumps on the skin
- Numbness / tingling
- Stiffness in arms and legs, muscle aches
- Pain or burning in the hands or forearms (called carpal tunnel syndrome )
Uncommon side effects (may affect up to 1 in 100 people):
- Breast augmentation ( gynecomastia )
Rare side effects (may affect up to 1 in 1,000 people):
- Leukemia (This has been reported in a small number of growth hormone deficient patients , some of whom have been treated with somatropin. However, there is no evidence that leukemia is more common among those receiving growth hormone and who have no risk factors.)
- Increased intracranial pressure (which may cause symptoms in the form of severe headache, visual disturbances or vomiting)
Has been reported (occurs in an unknown number of users) :
- Type 2 diabetes
- A decrease in the levels of the hormone a cortisol in the blood
- Swelling of the face
- Increased intracranial pressure (which may cause symptoms in the form of severe headache, visual disturbances or vomiting)
The formation of antibodies against the injected growth hormone, but these do not appear to prevent the growth hormone from working.
The skin around the injection site may become bumpy or lumpy, but this should not happen if you change the injection site every time.
Rare cases of sudden death have been reported in patients with Prader-Willi syndrome. However, these cases have not been associated with treatment with Omnitrope.
Epiphysiolysis of the hip and Legg ‑ Calvé ‑ Perthes disease may be considered by your doctor if you experience discomfort or pain in the hip or knee during treatment with Omnitrope.
Other possible side effects associated with your growth hormone treatment may be the following:
You (or your child) may have high blood sugar or lowered thyroid hormone levels. Your doctor can test this and, if necessary, prescribe appropriate treatment. Rare cases of inflammation of the pancreas have been reported in patients treated with growth hormone.
How to store Omnitrope
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 carton after EXP or EXP. The expiration date is the last day of the specified month.
- Store and transport cold (2 ° C – 8 ° C).
- Do not freeze.
- Store in the original package. Sensitive to light.
- After the first injection , the cartridge should remain in the pen and be stored in a refrigerator at 2 ° C – 8 ° C and used for a maximum of 28 days.
Do not use Omnitrope if you find the solution cloudy.
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
Omnitrope 5 mg / 1.5 ml
- The active substance is somatropin.Each ml of solution contains 3.3 mg of somatropin (equivalent to 10 IU).One cartridge contains 5.0 mg (equivalent to 15 IU) of somatropin in 1.5 ml.
- Other ingredients are:disodium hydrogen phosphate heptahydratesodium dihydrogen phosphate dihydratemannitolpoloxamer 188benzyl alcoholwater for injections
Omnitrope 10 mg / 1.5 ml
- The active substance is somatropin.Each ml of solution contains 6.7 mg of somatropin (equivalent to 20 IU).One cartridge contains 10.0 mg (equivalent to 30 IU) of somatropin in 1.5 ml.
- Other ingredients are:disodium hydrogen phosphate heptahydratesodium dihydrogen phosphate dihydrateglycinepoloxamer 188phenolwater for injections
Omnitrope 15 mg / 1.5 ml
- The active substance is somatropin.Each ml of solution contains 10 mg of somatropin (equivalent to 30 IU).One cartridge contains 15.0 mg (equivalent to 45 IU) of somatropin in 1.5 ml.
- Other ingredients are:disodium hydrogen phosphate heptahydratesodium dihydrogen phosphate dihydratesodium chloridepoloxamer 188phenolwater for injections
What the medicine looks like and contents of the pack
Omnitrope is a clear and colorless solution for injection.
Omnitrope 5 mg / 1.5 ml solution for injection is for use with SurePal 5 only.
Omnitrope 10 mg / 1.5 ml solution for injection is for use with SurePal 10 only.
Omnitrope 15 mg / 1.5 ml solution for injection is for use with SurePal 15 only.
Pack sizes: 1, 5, and 10.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
A-6336 Long-distance fighting