Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands
Fyremadel 0.25 mg/0.5 ml solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled syringe. Clear and colourless aqueous solution with a pH between 4.5 to 5.5 and an osmolality between 250 to 350 mOsm/kg. |
Each pre-filled syringe contains 0.25 mg of ganirelix (as acetate) in 0.5 ml aqueous solution. The active substance ganirelix (as acetate) (INN) is a synthetic decapeptide with high antagonistic activity to the naturally occurring gonadotrophin releasing hormone (GnRH). The amino acids at positions 1, 2, 3, 6, 8 and 10 of the natural GnRH decapeptide have been substituted resulting in N-Ac-D-Nal(2)1, D-pClPhe2, D-Pal(3)3, D-hArg(Et2)6, L-hArg(Et2)8, D-Ala10]-GnRH with a molecular weight of 1570.4.
Excipient with known effect:
Sodium.
Each pre-filled syringe contains <1 mmol sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ganirelix |
Ganirelix is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland. As a result a rapid, profound, reversible suppression of endogenous gonadotrophins occurs, without initial stimulation as induced by GnRH agonists. |
| List of Excipients |
|---|
|
Acetic acid, glacial (E260) The pH may have been adjusted with sodium hydroxide and acetic acid, glacial. |
Pre-filled syringes made of colourless type I glass containing 0.5 ml of sterile, ready for use, aqueous solution closed with the grey rubber plunger stopper and polypropylene plunger rod. Injection needles (27 G) affixed to the barrel and provided with grey elastomeric needle shield and polypropylene rigid needle shield. Each pre-filled syringe is affixed with a needle covered with a needle cover containing dry natural rubber/latex which comes into contact with the needle.
Supplied in cartons containing 1 or 5 pre-filled syringes.
Not all pack sizes may be marketed.
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands
PL 31750/0055
Date of first authorisation: 22 May 2013
Date of latest renewal: 31 August 2018
| Drug | Countries | |
|---|---|---|
| FYREMADEL | Spain, Finland, France, Malta, Netherlands, Poland, United Kingdom |
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