Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
GONAPEPTYL DEPOT 3.75 mg.
Powder and solvent for suspension for injection.
Powder and solvent for suspension for injection prolonged release in pre-filled syringes.
Before mixing: White to faintly yellow powder and a clear colourless aqueous liquid.
After mixing: Homogeneous milky white to faintly yellow suspension.
One pre-filled syringe contains 3.75 mg triptorelin (as acetate) to be suspended in one ml sodium containing suspension agent.
The product contains 3.69 mg/ml equivalent to 0.160 mmol/ml sodium after reconstitution.
For a full list of excipients, see section 6.1.
One pre-filled syringe with powder contains:
Poly-(d,l lactide coglycolide)
Propylene glycol dicaprylocaprate
One pre-filled syringe with one ml suspension agent contains:
Sodium hydrogen phosphate dihydrate
Water for injection
Powder: Pre-filled syringe.
Solvent: Pre-filled syringe.
Pre-filled syringes (borosilicate glass type I, clear) with a connector (polypropylene), black chlorobutyl rubber stopper (plunger stopper, type I) and injection needle.
1 pre-filled syringe (powder) plus
1 pre-filled syringe (solvent)
3 pre-filled syringes (powder) plus
3 pre-filled syringes (solvent)
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
15th April 2009
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