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.
| Pharmaceutical Form |
|---|
|
Powder and solvent for suspension for injection prolonged release in pre-filled syringes. Visual descriptionBefore 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.
| 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) One pre-filled syringe with one ml suspension agent contains: Dextran 70 |
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)
Ferring Pharmaceuticals Ltd., Drayton Hall, Church Road, West Drayton, UB7 7PS, United Kingdom
PL 03194/0085
15th April 2009
| Drug | Countries | |
|---|---|---|
| GONAPEPTYL | Brazil, Spain, Finland, France, Ireland, Mexico, Netherlands, Poland, Romania, Tunisia, Turkey, United Kingdom, South Africa |
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