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