Omnitrope 15 mg/1.5 ml solution for injection in cartridge
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Omnitrope 5mg/1.5ml solution for injection in cartridge
Omnitrope 10mg/1.5ml solution for injection in cartridge
Omnitrope 15mg/1.5ml solution for injection in cartridge
somatropin
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Omnitrope is and what it is used for
- What you need to know before using Omnitrope
- How to use Omnitrope
- Possible adverse effects
- How to store Omnitrope
- Contents of the pack and other information
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 necessary for bones and muscles to grow. It also helps fatty and muscle tissues develop in the correct 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 properly and do not have enough of your own growth hormone.
- If you have Turner syndrome, which is a genetic disorder in girls that can affect growth; your doctor will have told you if you have this condition.
- If you have chronic renal insufficiency. As the kidneys lose their ability to function normally, this can affect growth.
- If you were too small or thin at birth. Growth hormone may help you grow more if you have not had a growth spurt or maintained normal growth by the age of four years or beyond.
- If you have Prader-Willi syndrome (a chromosomal disorder). Growth hormone may help you grow more if you continue to grow, and will also improve your body composition. Excess fat will decrease and reduced muscle mass will improve.
In adults, Omnitrope is used to
- treat people with a marked deficiency of growth hormone. This deficiency may begin in adulthood or may continue from childhood.
If you were treated with Omnitrope for growth hormone deficiency during childhood, your growth hormone status will be re-evaluated after growth has ended. If a severe growth hormone deficiency is confirmed, your doctor will propose continuing treatment with Omnitrope.
You should only receive this medicine from a doctor experienced in growth hormone therapy, who has confirmed your diagnosis.
2. What you need to know before using Omnitrope
Do not use Omnitrope
- if you are allergic (hypersensitive) to somatropin or to any of the other components of Omnitrope.
- and inform your doctor if you have an active tumor (cancer). Tumors must be inactive and you must have completed your anti-tumor treatment before starting treatment with Omnitrope.
- and inform your doctor if Omnitrope has been prescribed to stimulate growth but you have already stopped growing (closed epiphyses).
- if you are seriously ill (e.g., complications following open-heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to undergo or have recently undergone major surgery, or if you are admitted to hospital for any reason, inform your doctor and remind other physicians you see that you are using growth hormone.
Warnings and precautions
Talk to your doctor before starting to use 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 should monitor your blood glucose levels regularly during treatment with somatropin.
- If you have diabetes mellitus, you should carefully monitor your blood glucose levels during treatment with somatropin and discuss the results with your doctor to determine whether your diabetes medication dose needs to be changed.
- After starting treatment with somatropin, some patients may need to start thyroid hormone replacement therapy.
- If you are receiving thyroid hormone therapy, your thyroid hormone dose may need to be adjusted.
- If you develop increased intracranial pressure (which causes symptoms such as severe headache, visual disturbances, or vomiting), inform your doctor.
- If you walk with a limp or start limping during treatment with growth hormone, inform your doctor.
- If you are receiving somatropin for growth hormone deficiency following a previous tumor (cancer), you should be monitored regularly for tumor recurrence or any other cancer.
- If you experience worsening abdominal pain, inform your doctor.
- Experience in patients over 80 years of age is limited. Elderly individuals may be more sensitive to the effects of somatropin and therefore may be more prone to adverse reactions.
- Omnitrope may cause inflammation of the pancreas, which causes severe pain in the abdomen and back. Contact your doctor if you or your child develops stomach pain after administration of Omnitrope.
- Lateral curvature of the spine (scoliosis) may worsen in any child during rapid growth. Your doctor will examine you (or your child) for signs of scoliosis during treatment with somatropin.
Children with chronic renal insufficiency
- Your doctor should assess kidney function and growth rate before starting treatment with somatropin. Medical treatment for kidney disease must continue. Treatment with somatropin should be discontinued in case of kidney transplantation.
Children with Prader-Willi syndrome
- Your doctor will give you dietary restrictions to follow in order to control your weight.
- Your doctor will evaluate signs of upper airway obstruction, sleep apnea (when breathing stops during sleep), or respiratory infection before starting treatment with somatropin.
- During treatment with somatropin, inform your doctor if you develop signs of upper airway obstruction (including new onset or worsening snoring). Your doctor may need to examine you and may discontinue treatment with somatropin.
- During treatment, your doctor will monitor you for signs of scoliosis, a type of spinal deformity.
- During treatment, if you develop a lung infection, inform your doctor so that the infection can be treated.
Children born too small or with low birth weight
- If you were very small or underweight at birth and are between 9 and 12 years old, consult your doctor specifically about puberty and treatment with this medicine.
- Treatment should continue until you have stopped growing.
- Your doctor will check glucose and insulin levels before starting treatment and annually during treatment.
Using Omnitrope with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 Omnitrope or of the other medicines:
- medicines for treating diabetes;
- thyroid hormones;
- medicines for controlling epilepsy (anticonvulsants);
- cyclosporine (a medicine that suppresses the immune system after transplants);
- orally administered estrogens 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 breastfeeding
You must not use Omnitrope if you are pregnant or trying to become pregnant.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because benzyl alcohol may accumulate in your body and cause adverse effects ("metabolic acidosis").
Important information about some of the components of Omnitrope
This medicine contains less than 1 mmol of sodium (23 mg) per ml; that is, essentially "sodium-free".
Omnitrope 5 mg/1.5 ml injectable solution:
This medicine contains 9 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.
Do not administer to your newborn (up to 4 weeks of age) unless recommended by your doctor.
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects ("metabolic acidosis").
Due to the presence of benzyl alcohol, this medicine must not be administered to premature infants or newborns. It may cause toxic and allergic reactions in children up to 3 years of age.
This product should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.
3. How to use Omnitrope
Follow exactly the instructions for administering this medicine as given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.
The dose depends on your size, the condition being treated, and how well the growth hormone works in you. 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 on your body surface area calculated from your height and weight in square meters (m²), as well as your treatment regimen. Do not change the dosage or treatment regimen without consulting your doctor.
Recommended dose for:
Children with growth hormone deficiency:
0.025 to 0.035 mg/kg body weight per day or 0.7 to 1.0 mg/m² body surface area per day. Higher doses may be used. When growth hormone deficiency continues during adolescence, Omnitrope should be continued until physical development is complete.
Girls with Turner syndrome:
0.045 to 0.050 mg/kg body weight per day or 1.4 mg/m² body surface area per day.
Children with chronic renal insufficiency:
0.045 to 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 velocity is too low. Dose adjustment may be required after six 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 used in children who have nearly stopped growing after puberty.
Children born small or with lower weight than expected and with a growth disorder:
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 discontinued after the first year if there is no response, or if final height has been achieved and growth has stopped.
Adults with growth hormone deficiency:
If you continue using Omnitrope after childhood treatment, start with 0.2 to 0.5 mg per day.
This dosage should be gradually increased or decreased based on blood test results, as well as clinical response and side effects.
If growth hormone deficiency begins during adulthood, start with 0.15 to 0.3 mg per day. This dosage should be gradually increased based on blood test results, as well as clinical response and side effects. Maintenance doses rarely exceed 1.0 mg daily. Women may require higher doses than men. Dosage should be reviewed every six months. Patients over 60 years of age should start with a dose of 0.1 to 0.2 mg daily, which should be slowly increased according to individual needs. The lowest effective dose should be used. Maintenance doses rarely exceed 0.5 mg per day. Follow your doctor's instructions.
Omnitrope injection
Inject the growth hormone at approximately the same time each day. Bedtime is a good time because it is easy to remember. In addition, it is also natural to have higher levels of growth hormone at night.
Omnitrope 5 mg/1.5 ml in a cartridge for SurePal 5 is intended for multiple uses. It must only be administered with SurePal 5, an injection device specifically developed for use with Omnitrope 5 mg/1.5 ml injectable solution.
Omnitrope 10 mg/1.5 ml in a cartridge for SurePal 10 is intended for multiple uses. It must only be administered with SurePal 10, an injection device specifically developed for use with Omnitrope 10 mg/1.5 ml injectable solution.
Omnitrope 15 mg/1.5 ml in a cartridge for SurePal 15 is intended for multiple uses. It must only be administered with SurePal 15, an injection device specifically developed for use with Omnitrope 15 mg/1.5 ml injectable solution.
Omnitrope is indicated for subcutaneous use. This means it is injected with a small injection needle into the fatty tissue beneath the skin. Most people inject into the thigh or buttocks. Inject at the site shown to you by your doctor. The fatty tissue under the skin may decrease at the injection site. To avoid this, use a slightly different site each time. This allows the skin and underlying tissue time to recover from one injection before another is given at the same site.
Your doctor should have already taught you how to use Omnitrope. Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
How to inject Omnitrope
The following instructions explain how to self-inject Omnitrope. Read the instructions carefully and follow them step by step. Your doctor or nurse will teach you how to inject Omnitrope. Do not attempt to inject yourself unless you are certain you understand the procedure and what is involved in the injection.
- Omnitrope is administered as an injection under the skin.
- Carefully inspect the solution before injecting and use only if it is clear and colorless.
- Change the injection site to minimize the risk of local lipoatrophy (local reduction of fatty tissue under the skin).
Preparation | |
Before starting, you must have all the necessary items: |
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Injecting Omnitrope | |
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If you use more Omnitrope than you should
If you inject much more than you should, consult your doctor or pharmacist as soon as possible. Your blood sugar concentration could drop too low and then rise too high. You may feel shaky, sweaty, drowsy, or "not like yourself," and you could faint.
If you forget to use Omnitrope
Do not use a double dose to make up for missed doses. It is best to use growth hormone regularly. If you forget to take a dose, administer the next injection at the usual time, the following day. Make a note of any missed injections and inform your doctor at the next check-up.
If you stop using Omnitrope
Consult your doctor before stopping the use of Omnitrope.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Very common and common adverse effects in adults may begin during the first months of treatment and may resolve spontaneously or if the dose is reduced.
Very common adverse effects (likely to occur in more than 1 in 10 people) include the following:
In adults
- Joint pain
- Water retention (presenting as swelling of the fingers or ankles)
Common adverse effects (likely to affect fewer than 1 in 10 people) include the following:
In children
- Joint pain
- Temporary redness, itching, or pain at the injection site
In adults
- Numbness, tingling
- Pain or burning sensation in the hands or forearms (known as carpal tunnel syndrome)
- Stiffness of the arms and legs, muscle pain
Uncommon adverse effects (likely to affect fewer than 1 in 100 people) include the following:
In children
- Leukaemia (observed in a small number of patients with growth hormone deficiency, some of whom had been treated with somatropin. However, there is no indication that the incidence of leukaemia is higher in growth hormone recipients without predisposing factors)
- Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances, or vomiting)
- Numbness, tingling
- Itching
- Itchy skin rash (urticaria)
- Skin rash
- Muscle pain
- Enlargement of the breasts (gynaecomastia)
- Water retention (presenting as swelling of the fingers or ankles, for a short period at the beginning of treatment)
In adults
- Enlargement of the breasts (gynaecomastia)
Frequency not known (cannot be estimated from available data)
- Type 2 diabetes
- Facial swelling
- Headache
- Decreased levels of cortisol hormone in the blood
- Hypothyroidism
In children
- Stiffness of the arms and legs
In adults
- Increased intracranial pressure (causing symptoms such as severe headache, visual disturbances, or vomiting)
- Skin rash
- Itching
- Itchy skin rash (urticaria)
- Redness, itching, or pain at the injection site
Formation of antibodies against the injected growth hormone; however, these do not appear to cause loss of effectiveness of the growth hormone.
The skin around the injection site may become irregular or lumpy, but this should not occur if you inject in a different location each time.
Rare cases of sudden death have been reported in patients with Prader-Willi syndrome. However, these cases have not been linked to treatment with Omnitrope.
Your doctor may consider slipped capital femoral epiphysis or Legg-Calvé-Perthes disease if you experience hip or knee pain or discomfort while being treated with Omnitrope.
Other possible adverse effects related to your treatment with growth hormone may include the following:
You (or your child) may have elevated blood sugar levels or reduced thyroid hormone levels. Your doctor can test for these and, if necessary, prescribe appropriate treatment. Pancreatitis has been observed rarely in patients treated with growth hormone.
Reporting of adverse effects
If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Omnitrope
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.
- Store and transport refrigerated (between 2°C and 8°C).
- Do not freeze.
- Keep in the original packaging to protect from light.
- After the first injection has been administered, the cartridge must remain in the pen injector and should be stored in a refrigerator at a temperature of 2 to 8 °C and used within a maximum of 28 days.
Do not use Omnitrope if the solution appears cloudy.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Omnitrope 5 mg/1.5 ml
- The active substance is somatropin.
Each ml of solution contains 3.3 mg of somatropin (corresponding to 10 IU).
One cartridge contains 5.0 mg (corresponding to 15 IU) of somatropin in 1.5 ml.
- The other components are:
Disodium hydrogen phosphate heptahydrate
Sodium dihydrogen phosphate dihydrate
Mannitol
Poloxamer 188
Benzyl alcohol
Water for injections
Composition of Omnitrope 10 mg/1.5 ml
- The active substance is somatropin.
Each ml of solution contains 6.7 mg of somatropin (corresponding to 20 IU).
One cartridge contains 10.0 mg (corresponding to 30 IU) of somatropin in 1.5 ml.
- The other components are:
Disodium hydrogen phosphate heptahydrate
Sodium dihydrogen phosphate dihydrate
Glycine
Poloxamer 188
Phenol
Water for injections
Composition of Omnitrope 15 mg/1.5 ml
- The active substance is somatropin.
Each ml of solution contains 10 mg of somatropin (corresponding to 30 IU).
One cartridge contains 15.0 mg (corresponding to 45 IU) of somatropin in 1.5 ml.
- The other components are:
Disodium hydrogen phosphate heptahydrate
Sodium dihydrogen phosphate dihydrate
Sodium chloride
Poloxamer 188
Phenol
Water for injections
Nature of the product and contents of the pack
Omnitrope is a clear, colourless injectable solution.
Omnitrope 5 mg/1.5 ml solution for injection is for use in SurePal 5 only.
Omnitrope 10 mg/1.5 ml solution for injection is for use in SurePal 10 only.
Omnitrope 15 mg/1.5 ml solution for injection is for use in SurePal 15 only.
Pack sizes containing 1, 5 or 10 cartridges.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Sandoz GmbH
Biochemiestr. 10
A-6250 Kundl
Austria
Manufacturer
Sandoz GmbH
Biochemiestr. 10
A-6336 Langkampfen
Austria
Novartis Pharmaceutical Manufacturing GmbH
Biochemiestr. 10
A-6336 Langkampfen
Austria
Date of the most recent revision of this leaflet: {MM/YYYY}
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Further information on this medicine is available upon request from the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Sandoz nv/sa Tel/Tel: +32 2 722 97 97 | Lithuania Sandoz Pharmaceuticals d.d. branch Tel: +370 5 2636 037 |
| Luxembourg/Luxembourg Sandoz nv/sa (Belgium/Belgium) Tel/Tel.: +32 2 722 97 97 |
Czech Republic Sandoz s.r.o. Tel: +420 234 142 222 | Hungary Sandoz Hungária Kft. Tel.: +36 1 430 2890 |
Denmark/Norway/Iceland/Sweden Sandoz A/S Tlf: +45 63 95 10 00 | Malta Sandoz Pharmaceuticals d.d. Tel: +35699644126 |
Germany Hexal AG Tel: +49 8024 908 0 | Netherlands Sandoz B.V. Tel: +31 36 52 41 600 |
Estonia Sandoz d.d. Estonia branch Tel: +372 665 2400 | Austria Sandoz GmbH Tel: +43 5338 2000 |
Greece SANDOZ HELLAS MONOPROSOPIKI EPE Tel: +30 216 600 5000 | Poland Sandoz Polska Sp. z o.o. Tel.: +48 22 209 70 00 |
Spain Sandoz Farmacéutica, S.A. Tel: +34 900 456 856 | Portugal Sandoz Farmacêutica Lda. Tel: +351 21 000 86 00 |
France Sandoz SAS Tel: +33 1 49 64 48 00 | Romania Sandoz Pharmaceuticals SRL Tel: +40 21 407 51 60 |
Croatia Sandoz d.o.o. Tel: +385 1 23 53 111 | Slovenia Sandoz farmacevtska družba d.d. Tel: +386 1 580 29 02 |
Ireland Rowex Ltd. Tel: + 353 27 50077 | Slovakia Sandoz d.d. - organizational unit Tel: +421 2 48 200 600 |
Italy Sandoz S.p.A. Tel: +39 02 8128069 | Finland/Finland Sandoz A/S Puh/Tel: +358 10 6133 400 |
Cyprus Sandoz Pharmaceuticals d.d. Tel: +357 22 69 0690 | |
Latvia Sandoz d.d. Latvia branch Tel: +371 67 892 006 |
