What is it and how is it used?

Omnitrope is a recombinant human growth hormone (also called somatropin). It has the same structure as natural human growth hormone which is needed for bones and muscles to grow. It also helps your fat and muscle tissues to develop 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 disturbances:

  • If you are not growing properly and 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 will have told you if you have this.
  • If you have chronic renal (kidney) insufficiency. As kidneys lose their ability to function normally this can affect growth.
  • If you were small or too light at birth. Growth hormone can help you grow taller if you have not been able to catch up or maintain normal growth by 4 years of age or later.
  • If you have Prader-Willi syndrome (a genetic disorder). Growth hormone will help you grow taller if you are still growing, and will also improve your body composition. Your excessive fat will decrease and your reduced muscle mass will improve.
In adults Omnitrope is used to

  • Treat persons with pronounced growth hormone deficiency. This can start during either adult life or it can continue from childhood. If you have been treated with Omnitrope for growth hormone deficiency during childhood, your growth hormone status will be retested after completion of growth. If severe growth hormone deficiency is confirmed, your doctor will propose continuation of Omnitrope treatment
Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use Omnitrope

  • If you are allergic (hypersensitive) to somatropin or to any of the other ingredients of Omnitrope.
  • If you have an active tumour (cancer). Tumours must be inactive and you must have finished your ant-tumour treatment before you start using Omnitrope. .
  • To stimulate growth if growing is already finished (closed epiphyses).
  • If you are seriously ill (for example, complications following open-heart surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar conditions). If you are about to have, or have had, a major operation, or go into hospital for any reason, tell your doctor and remind other doctors you are seeing that you use growth hormone.
Take special care with Omnitrope

  • If you are at risk of developing diabetes, your doctor will need to monitor your blood sugar level during therapy with somatropin.
  • If you have diabetes, you should closely monitor your blood sugar level during treatment with somatropin and discuss the results with your doctor to determine whether you need to change the dose of your medicines to treat diabetes.
  • After starting somatropin treatment some patients may need to start thyroid hormone replacement.
  • If you are receiving treatment with thyroid hormones it may become necessary to adjust your thyroid hormone dose.
  • If you have raised intracranial pressure ( which causes symptoms, such as strong headache, visual problems, or vomiting) you should inform your doctor about it..
  • 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 receiving somatropin for growth hormone deficiency following a previous tumour (cancer), you should be examined regularly for recurrence of the tumour.
  • If you are over 60 years old. Elderly persons may be more sensitive to the action of somatropin, and therefore may be more prone to develop side effects.
Children with chronic renal (kidney) insufficiency

  • Your doctor should examine your kidney function and your growth rate before starting somatropin. Medical treatment for your kidney should be continued. Somatropin treatment should be stopped at kidney transplantation.
Children with Prader-Willi syndrome

  • Your doctor will give you diet restrictions to follow to control your weight.
  • Your doctor will assess you for signs of upper airway obstruction, sleep apnoea (where your breathing is interrupted during sleep), or respiratory infection before you start treatment with somatropin.
  • During treatment with somatropin, tell your doctor if you show signs of upper airway obstruction (including starting to snore or worsening of snoring), your doctor will need to examine you and may interrupt treatment with somatropin.
  • During treatment, your doctor will check you for signs of scoliosis, a type of spinal deformity.
  • During treatment, if you develop a lung infection, tell your doctor so that he can treat the infection.
Children born small or too light at birth

  • If you were too small or too light at birth and are aged between 9 and 12 years, ask your doctor for specific advice relating to puberty and treatment with this medicine.
  • Treatment should be continued until you have stopped growing.
  • Your doctor will check your blood sugar and insulin levels before the start of treatment and every year during treatment.
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.

You should tell your doctor if you are using:

  • medicine to treat diabetes,
  • thyroid hormones,
  • medicines to control epilepsy (anticonvulsants),
  • ciclosporin (a medicine that weakens the immune system after transplantation),
  • sex hormones (for example oestrogens),
  • 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 before using this medicine while breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of Omnitrope

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

How is it used?

You should only be given this medicine by a doctor who has experience with growth hormone treatment and who has confirmed your diagnosis.

Recommended dosage
The dose depends on your size, the condition for which you are being treated and how well growth hormone works for you. Your doctor will advise you about your individualised dose of Omnitrope in milligrams (mg) from either your body weight in kilograms (kg) or your body surface area calculated from your height and weight in square metres (m2), as well as your treatment schedule. Do not change the dosage and treatment schedule without 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 body surface area per day. Higher doses can be used. When growth hormone deficiency continues into adolescence, Omnitrope 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 body surface area per day.

Children with chronic renal (kidney) insufficiency:

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 the rate of growth is too low. Dosage 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 dosage should not exceed 2.7 mg. Treatment should not be used in children who have almost stopped growing after puberty.

Children born smaller or lighter than expected and with growth disturbance: 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 you are not responding or if you have reached your final height and stopped growing

Adults with growth hormone deficiency:

If your growth hormone deficiency starts during adult life you should start with 0.15-0.3 mg per day. This dosage should be gradually increased according to blood test results as well as clinical response and side effects. The daily maintenance dose seldom exceeds 1.0 mg per day. Women may require higher doses than men. Dosage should be monitored every 6 months. The minimum effective dose should be used. Follow the instructions given to you by your doctor.

Injecting Omnitrope

Omnitrope is intended for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under your skin. Your doctor should have already shown you how to use Omnitrope. Always inject Omnitrope exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to inject Omnitrope 1.3 mg/ml

The following instructions explain how to inject Omnitrope 1.3 mg/ml yourself. Please read the instructions carefully and follow them step by step. Your doctor will show you how to inject Omnitrope. Do not attempt to inject unless you are sure you understand the procedure and requirements for injection.

  • After reconstitution, Omnitrope is given as an injection under the skin.
  • Carefully inspect the solution before injecting it and use only if clear and colourless.
  • Change the injection sites to minimise the risk of local lipoatrophy (local reduction of fatty tissue under the skin).

Preparation Collect necessary items before you begin a vial with Omnitrope 1.3 mgml powder for solution for injection. a vial with solvent liquid for Omnitrope 1.3 mgml. a sterile, disposable syringe e.g. 2 ml syringe and needle e.g. 0.33 mm x 12.7 mm for withdrawing the solvent from the vial not supplied in the pack. a sterile, disposable syringe of appropriate size e.g. 1 ml syringe and injection needle e.g. 0.25 mm x 8 mm for subcutaneous injection not supplied in the pack. 2 cleansing swabs not supplied in the pack.

Wash your hands before you continue with the next steps.

Reconstituting Omnitrope Remove the protective caps from the two vials in the box. With a cleansing swab, disinfect the rubber membranes of both the powder-filled and the solvent-filled vial. Take the vial with solvent and the sterile, disposable syringe e.g. 2 ml syringe and needle e.g. 0.33 mm x 12.7 mm. Push the needle fitted to the syringe through the rubber membrane. Turn the vial with the solvent upside down and withdraw all the solvent from the vial.

Take the vial with the powder and push the needle through the rubber membrane of the vial. Inject the solvent slowly. Aim the stream of liquid against the glass wall in order to avoid foam. Remove the syringe and needle. Gently swirl the reconstituted vial until the content is completely dissolved. Do not shake. If the solution is cloudy and the cloudiness does not disappear within ten minutes or contains particles, it should not be used. The contents must be clear and colourless.

  • Use the solution immediately.

Measuring the dose of Omnitrope to be injected Take the sterile, disposable syringe of appropriate size e.g. 1 ml syringe and injection needle e.g. 0.25 mm x 8 mm. Push the needle through the rubber stopper of the vial with the reconstituted solution. Turn the vial and the syringe upside down in one hand. Be sure that the tip of the syringe is in the Omnitrope reconstituted solution. Your other hand will be free to move the plunger. Pull back on the plunger slowly and withdraw just a bit more than the dose prescribed by your doctor into the syringe. Hold the syringe with the needle in the vial pointing up and remove the syringe from the vial. Check for air bubbles in the syringe. If you see any bubbles, pull the plunger slightly back tap the syringe gently, with the needle pointing upwards, until the bubbles disappear. Push up the plunger slowly back to the correct dose. Inspect the reconstituted solution visually prior to administration. Do not use if the solution is cloudy or contains particles. You are now ready to inject the dose.

Injecting Omnitrope Select the site of injection. The best sites for injection are tissues with a layer of fat between skin and muscle, such as the thigh or belly except the navel or waistline. Make sure you inject at least 1 cm from your last injection site and that you change the places where you inject, as you have been taught. Before you make an injection, clean your skin well with an alcohol swab. Wait for the area to dry. With one hand, pitch a fold of loose skin. With your other hand, hold the syringe as you would a pencil. Insert the needle into the pinched skin at an angle of 45 to 90. After the needle is in, remove the hand used to pinch the skin and use it to hold the syringe barrel. Pull back the plunger very slightly with one hand. If blood comes into the syringe, the needle has entered a blood vessel. Do not inject into this site withdraw the needle and repeat this step. Inject the solution by pushing the plunger all the way down gently. Pull the needle straight out of the skin.

After injecting

  • After injection, press the injection site with a small bandage or sterile gauze for several seconds. Do not massage the injection site.
  • The residual solution, vials, and injection materials intended for single use must be discarded. Dispose of the syringes safely in a closed container.
If you use more Omnitrope than you should

If you inject much more than you should, contact your doctor or pharmacist as soon as possible. Your blood sugar level could fall too low and later rise too high. You might feel shaky, sweaty, sleepy or ?not yourself?, and you might faint.

If you forget to use Omnitrope

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

If you stop using Omnitrope

Ask your doctor for advice before you stop using somatropin.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Omnitrope can cause side effects, although not everybody gets them.

Common side effects (likely to occur in fewer than 1 in 10 patients) include:

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

In children

  • Temporary reddening, itchiness or pain at the injection site.
In adults

  • numbness/tingling
  • stiffness in the arms and legs, joint pain, muscle pain,
  • Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of treatment). These symptoms may be seen at the beginning of treatment, but they disappear spontaneously or when the dosage is lowered. These common side effects in adults may start within the first months of treatment and may either stop spontaneously or if your dose is reduced.
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:

In children

  • numbness/tingling
  • stiffness in the arms and legs, joint pain, muscle pain,
  • Water retention (which shows as puffy fingers or swollen ankles, for a short time at the start of treatment).
In adults

  • pain or burning sensation in the hands or underarms (known as Carpal Tunnel Syndrome)
Rare side effects (likely to occur in fewer than 1 in 1,000 patients) include

  • Type 2 diabetes mellitus
  • Increased intracranial pressure (which causes symptoms, such as strong headache, visual problems, or vomiting).
Very rare side effects (likely to occur in fewer than 1 in 10,000 patients) include

  • Cancer of white blood cells (leukemia)

The skin around the injection area can get uneven or lumpy, but this should not happen if you inject in a different place each time.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use 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 refrigerated (2°C - 8°C).
  • Do not freeze.
  • Store in the original package in order to protect from light.
  • After reconstitution, from a microbiological point of view, the product should be used immediately. However, the in-use stability has been demonstrated for up to 24 hours at 2°C - 8°C, in the original package.
  • For single use only. Do not use Omnitrope if it was frozen or subject to high temperatures. Do not use Omnitrope if you notice that the solution is 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.

Further information

What Omnitrope contains

The active substance of Omnitrope is somatropin.
One vial contains 1.3 mg (corresponding to 4 IU) of somatropin after reconstitution with 1 ml solvent.

The other ingredients are:
Powder:
glycine
disodium hydrogen phosphate heptyhydrate
sodium dihydrogen phosphate dihydrate

Solvent:

water for injections

What Omnitrope looks like and contents of the pack

Powder and solvent for solution for injection (powder in a vial (1.3 mg), solvent in a vial (1 ml)). Pack size of 1.
The powder is white and the solvent is a clear, colourless solution.

Marketing Authorisation Holder and Manufacturer

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Sandoz nv-sa Telecom Gardens Medialaan 40 B-1800 Vilvoorde TélTel 32 02 722 97 97 LuxembourgLuxemburg Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Austria Tel 43-05338 2000

aa p .T.ate S Gt 31- 3042 ees f 357 25372425 Magyarország Sandoz Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest Tel. 36 1 430 2890

eská republika Sandoz s.r.o. U Nákladového nádraí 10 CZ 130 00 Praha 3 Tel 420 221 421 611 Malta Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Austria Tel 43-05338 2000

Nederland Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel 31 36 52 41 600 Danmark Sandoz AS Edvard Thomsens Vej 14 2300 København S Danmark Tlf 45 6395 1000

Deutschland Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Tel 49 08024 902 40 00 E-Mail infosandoz.de Norge Sandoz AS Edvard Thomsens Vej 14 DK-2300 København S Danmark Tlf 45 6395 1000

Eesti Sandoz d.d. Eesti filiaal Pärnu mnt 105 EE - 11312 Tallinn Tel 372 665 2400 Österreich Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Tel 43-05338 2000

Polska Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C PL 02 672 Warszawa Tel. 48-22 549 15 00 Sambrook .. 4 . .. 135 61 . 30 210 8323 372

Portugal Sandoz Farmacêutica Lda. Alameda da Beloura, Edifício 1 España Sandoz Farmacéutica, SA Avda. Osa Mayor, 4 E-28023 Aravaca Madrid Tel 34 91 740 12 80 2o andar Escritório 15 P-2710-693 Sintra Tel 351 21 000 86 00

France Sandoz S.A.S. 49 Avenue Georges Pompidou F-92593 Levallois Perret Tél 33 01 49 64 48 00 România Sandoz SRL str. Livezeni, Nr 7A Târgu Mure 540472 RO Tel 40 265 208 120

Slovenija Lek farmacevtska druba d.d. Verovkova 57 SI-1526 Ljubljana Tel 386 01 580 21 11 Ireland Rowex Ltd Bantry Co. Cork - IRL Tel 353 0 27 50077 Email regrowa-pharma.ie

Slovenská republika Sandoz d.d. organizaná zloka Galvaniho 15C SK-821 04 Bratislava Tel 421-2-48 200 600 Ísland Sandoz AS Edvard Thomsens Vej 14 2300 København S Denmark Tlf 45 6395 1000

Italia Sandoz S.p.A. Largo U. Boccioni, 1 I-21040 Origgio Va Tel 39 02 96541 SuomiFinland Sandoz AS Edvard Thomsens Vej 14 2300 Kööpenhamina S Tanska PuhTel 45 6395 1000

Distributors for Cyprus P.T. Hadjigeorgiou co ltd Yildiz 31-3042 Limassol Tel 357 25372425 Latvija Sandoz d.d. Prstvniecba Latvij K. Valdemra 33-30 Riga, LV-1010 Tel 371 67 892 006 Sverige Sandoz AS Edvard Thomsens Vej 14 2300 Köpenhamn S Danmark Tel 45 6395 1000 United Kingdom Sandoz Limited Frimley Business Park FrimleyCamberley Surrey GU16 7SR UK Tel 44 1276 69 8020

Lietuva

Sandoz Pharmaceuticals d.d. Branch Office
Seimyniskiu str. 3A
LT 09312 Vilnius
Tel: +370 5 2636 038

This leaflet was last approved in

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