GONAPEPTYL DEPOT Powder and solvent for suspension for injection prolonged release Ref.[8225] Active ingredients: Triptorelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Product name and form

GONAPEPTYL DEPOT 3.75 mg.

Powder and solvent for suspension for injection.

Pharmaceutical Form

Powder and solvent for suspension for injection prolonged release in pre-filled syringes.

Visual description

Before mixing: White to faintly yellow powder and a clear colourless aqueous liquid.

After mixing: Homogeneous milky white to faintly yellow suspension.

Qualitative and quantitative composition

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.

Active Ingredient Description
Triptorelin

Triptorelin is a decapeptide analogue of GnRH which initially stimulates release of pituitary gonadotropins.

List of Excipients

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:

Dextran 70
Polysorbate 80
Sodium chloride
Sodium hydrogen phosphate dihydrate
Sodium hydroxide
Water for injection

Pack sizes and marketing

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.

Pack sizes:

1 pre-filled syringe (powder) plus
1 pre-filled syringe (solvent)
3 pre-filled syringes (powder) plus
3 pre-filled syringes (solvent)

Marketing authorization holder

Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom

Marketing authorization dates and numbers

PL 03194/0085

15th April 2009

Drugs

Drug Countries
GONAPEPTYL Brazil, Spain, Finland, France, Ireland, Mexico, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom, South Africa

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