Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: IBSA Farmaceutici Italia S.r.l, Via Martiri di Cefalonia 2, 26900 Lodi Italy
FOSTIMON 75 IU, powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
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Powder and solvent for solution for injection. The powder is white to off-white and the solvent is clear and colourless. |
One vial contains 75 IU of urofollitropin (follicle-stimulating hormone FSH): 1 ml of reconstituted solution contains either 75 IU, 150 IU, 225 IU, 300 IU, 375 IU or 450 IU of urofollitropin when respectively 1, 2, 3, 4, 5 or 6 vials are reconstituted in 1 ml of solvent.
The specific in vivo activity is equal or superior to 5000 IU of FSH per mg of protein. For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Urofollitropin |
Urofollitropin contains a highly purified preparation of urinary FSH extracted from the urine of postmenopausal women. FSH stimulates ovarian follicular growth and development as well as gonadal steroid production in women who do not have primary ovarian failure. |
| List of Excipients |
|---|
|
Powder: lactose monohydrate Solvent: sodium chloride and water for injections |
Powder in a vial (type I glass), with a stopper (bromobutylrubber), with a seal (aluminium) and a flip-off cap (plastic) + 1 ml of solvent in an ampoule (type I glass); pack size of 1, 5 and 10 sets.
Not all pack sizes may be marketed.
IBSA Farmaceutici Italia S.r.l, Via Martiri di Cefalonia 2, 26900 Lodi – Italy
PL 21039/0005
30/03/2006
| Drug | Countries | |
|---|---|---|
| FOSTIMON | Austria, Brazil, Cyprus, Ecuador, Finland, France, Ireland, Israel, Malta, Netherlands, Poland, Tunisia, Turkey, United Kingdom, South Africa |
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