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 5 mg/ml is intended for multiple use. It should only be administered with the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mg/ml powder and solvent for solution for injection.
Omnitrope is given 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 5 mg/ml
The following instructions explain how to inject Omnitrope 5 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 5 mgml powder for solution for injection. a cartridge with solvent for Omnitrope 5 mgml. a transfer set for mixing and transferring the reconstituted solution back into the cartridge see Instructions for Use of the pen injector. the Omnitrope Pen L, an injection device specifically developed for use with Omnitrope 5 mgml reconstituted solution for injection not supplied in the pack see Instructions for Use of the transfer set and of the injection device. a pen needle for subcutaneous injection. 2 cleansing swabs not supplied in the pack.
Wash your hands before you continue with the next steps.
Reconstituting Omnitrope Remove the protective cap from the vial. With a cleansing swab, disinfect both the rubber membrane of the vial with powder and the rubber membrane of the cartridge with solvent. Use the transfer set for transferring all the solvent from the cartridge into the vial. Follow the instructions that come with the transfer set. 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. Transfer all of the dissolved solution back into the cartridge using the transfer set.
Injecting Omnitrope Put the cartridge with the dissolved Omnitropeinto the pen for injection. Follow the Instructions for Use of the pen injector. To setup the pen dial the dose. Eliminate any air bubbles. 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. Insert the needle into the skin in the way your doctor has taught you.
After injecting
- After injection, press the injection site with a small bandage or sterile gauze for several seconds. Do not massage the injection site.
- Take the needle off the pen using the outer needle cap, and discard the needle. This will keep the Omnitrope solution sterile and prevent leaking. It will also stop air going back into the pen and the needle clogging up. Do not share your needles. Do not share your pen.
- Leave the cartridge in the pen, put the cap on the pen, and store it in the refrigerator.
- The solution should be clear after removal from the refrigerator. Do not use if the solution is cloudy or contains particles.
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.
