Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2022 Publisher: Ipsen Pty Ltd, Level 2, Building 4, Brandon Office Park, 540 Springvale Road, Glen Waverley Victoria 3150 Telephone: 1800 317 033
Triptorelin embonate.
| Pharmaceutical Form |
|---|
|
Powder and solvent for suspension for injection, prolonged release granules. White to off-white powder. |
Diphereline 3.75mg 1 month formulation: Each vial contains a triptorelin content which allows the administration of an effective dose of 3.75 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of reconstituted suspension contains 1.875 mg of triptorelin.
Diphereline 11.25mg 3 month formulation: Each vial contains a triptorelin content which allows the administration of an effective dose of 11.25 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of reconstituted suspension contains 5.625 mg of triptorelin.
Diphereline 22.5mg 6 month formulation: Each vial contains a triptorelin content which allows the administration of an effective dose of 22.5 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of reconstituted suspension contains 11.25 mg of triptorelin.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
Chemical structure:
[(L-Pyr)-(L-His)-(L-Trp)-(L-Ser)-(L-Tyr)-(D-Trp)-(L-Leu)-(L-Arg)-(L-Pro)-(Gly-NH2)]
Molecular formula: C64H82N18O13 (triptorelin). C23H16O6 (embonate)
Molecular weight: 1311.5 (triptorelin) + 388.4 (embonate)
CAS number: 57773-63-4
| Active Ingredient | Description | |
|---|---|---|
| Triptorelin |
Triptorelin is a decapeptide analogue of GnRH which initially stimulates release of pituitary gonadotropins. |
| List of Excipients |
|---|
|
Composition of the Powder: Polyglactin Composition of the Solvent: Water for Injections |
Diphereline 3.75 mg 1 month formulation: 6 mL type I brown tint glass vial with grey bromobutyl stopper and purple aluminium flip-off capsule.
Diphereline 11.25 mg 3 month formulation: 6 mL type I brown tint glass vial with grey bromobutyl stopper and yellow green aluminium flip-off capsule.
Diphereline 22.5 mg 6 month formulation: 6 mL type I brown tint glass vial with grey bromobutyl stopper and dark green aluminium flip-off capsule.
Solvent: Type I glass ampoule containing 2 mL of sterile solvent for suspension.
Each box contains 1 vial, 1 ampoule and 1 blister containing 1 empty polypropylene injection syringe and 2 injection needles.
Ipsen Pty Ltd, Level 2, Building 4, Brandon Office Park, 540 Springvale Road, Glen Waverley Victoria 3150
Telephone: 1800 317 033
Date of first approval: 28 August 2006
| Drug | Countries | |
|---|---|---|
| DIPHERELINE | Australia, Ecuador, Estonia, Hong Kong, Lithuania, Poland, Romania, Singapore |
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