Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Sandoz GmbH, Biochemiestr. 10, A-6250 Kundl, Austria
Omnitrope 5 mg/1.5 ml solution for injection in cartridge.
Omnitrope 10 mg/1.5 ml solution for injection in cartridge.
| Pharmaceutical Form |
|---|
|
Solution for injection. The solution is clear and colourless. |
Each ml of solution contains 3.3 mg of somatropin* (corresponding to 10 IU)
One cartridge contains 1.5 ml corresponding to 5 mg somatropin* (15 IU).
Excipient(s) with known effect:
This medicine contains 9 mg benzyl alcohol in each ml.
Benzyl alcohol may cause allergic reactions.
Each ml of solution contains 6.7 mg of somatropin* (corresponding to 20 IU)
One cartridge contains 1.5 ml corresponding to 10 mg somatropin* (30 IU).
* produced in Escherichia coli by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Somatropin is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins. In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate. In adults, as well as in children, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth, and by mobilization of body fat. |
| List of Excipients |
|---|
|
Omnitrope 5 mg/1.5 ml solution for injection: Disodium hydrogen phosphate heptahydrate Omnitrope 10 mg/1.5 ml solution for injection: Disodium hydrogen phosphate heptahydrate |
1.5 ml of solution in a cartridge (colourless type I glass) with plunger on one side (siliconised bromobutyl), a disc (bromobutyl) and a cap (aluminium) on the other side.
Pack sizes of 1, 5 and 10.
Not all pack sizes may be marketed.
Sandoz GmbH, Biochemiestr. 10, A-6250 Kundl, Austria
Omnitrope 5 mg/1.5 ml solution for injection:
EU/1/06/332/004
EU/1/06/332/005
EU/1/06/332/006
Omnitrope 10 mg/1.5 ml solution for injection:
EU/1/06/332/007
EU/1/06/332/008
EU/1/06/332/009
Date of first authorisation: 12 April 2006
Date of latest renewal: 28 February 2011
| Drug | Countries | |
|---|---|---|
| OMNITROPE | Albania, Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.