Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
GENOTROPIN 5.3 mg, powder and solvent for solution for injection.
| Pharmaceutical Form |
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Powder and solvent for solution for injection. In the two-chamber cartridge there is a white powder in the front compartment and a clear solution in the rear compartment. |
GENOTROPIN 5.3 mg powder and solvent for solution for injection, with preservative. One cartridge contains 5.3 mg somatropin*. After reconstitution the concentration of somatropin is 5.3 mg/ml.
* produced in Escherichia coli cells by recombinant DNA technology
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Somatropin |
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 |
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Powder: Front compartment Glycine (E640) Solvent: Rear compartment Water for injections |
Powder and 1 ml solvent in a two-chamber glass cartridge (type I glass) separated by a rubber plunger (bromobutyl). The cartridge is sealed at one end with a rubber disc (bromobutyl) and an aluminium cap and at the other end by a rubber stopper (bromobutyl). The two-chamber cartridge is supplied for use in a re-usable injection device GENOTROPIN Pen, or reconstitution device, GENOTROPIN Mixer or sealed in a disposable multidose pre-filled pen, GoQuick.
The GENOTROPIN Pens are colour coded, and must be used with the matching colour coded GENOTROPIN two-chamber cartridge to give the correct dose. The GENOTROPIN Pen 5.3 (blue) must be used with GENOTROPIN 5.3 mg cartridge (blue).
The 5.3 mg pre-filled pen GoQuick is colour coded blue.
1x5.3 mg, 5x5.3 mg, 1x5.3 mg pre-filled pen, 5x5.3 mg pre-filled pens.
Not all pack sizes may be marketed.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/0987
1 February 1995/21 April 2010
| Drug | Countries | |
|---|---|---|
| GENOTROPIN | Albania, Austria, Australia, Brazil, Canada, Ecuador, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom |
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