Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Orgalutran 0.25 mg/0.5 mL solution for injection.
| Pharmaceutical Form |
|---|
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Solution for injection. Clear and colourless aqueous solution. |
Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 mL aqueous solution. The active substance ganirelix (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: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, that is to say essentially ‘sodium-free’.
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 |
|---|
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Acetic acid The pH may have been adjusted with sodium hydroxide and acetic acid. |
Disposable pre-filled syringes (siliconised type I glass), containing 0.5 mL of sterile, ready for use, aqueous solution closed with a rubber piston that does not contain latex. Each pre-filled syringe is affixed with a needle closed by a needle cover of dry natural rubber/latex which comes into contact with the needle. (See section 4.4.)
Supplied in cartons containing 1 or 5 pre-filled syringes.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
EU/1/00/130/001, 1 pre-filled syringe
EU/1/00/130/002, 5 pre-filled syringes
Date of first authorisation: 17 May 2000
Date of last renewal: 10 May 2010
| Drug | Countries | |
|---|---|---|
| ORGALUTRAN | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, South Africa |
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