Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom
PROSTAP 3 DCS 11.25 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Powder and solvent for suspension for injection in pre-filled syringe. Powder: A sterile, lyophilised, white, odourless powder. Solvent: A clear, odourless, slightly viscous, sterile solvent. |
PROSTAP 3 Powder: contains 11.25 mg leuprorelin acetate (equivalent to 10.72 mg base).
Sterile Solvent: Each ml contains carmellose sodium 5 mg, mannitol (E421) 50 mg, polysorbate 80 1 mg, acetic acid, glacial up to 0.05 mg and water for injections.
When reconstituted with Sterile Solvent, the suspension contains 11.25 mg/ml leuprorelin acetate.
For the full list of excipients, see section 6.1
| Active Ingredient | Description | |
|---|---|---|
| Leuprorelin |
Leuprorelin is inactive when given orally due to poor membrane permeability and an almost complete inactivation by intestinal proteolytic enzymes. Leuprorelin has potent LHRH agonist properties when given during short-term and intermittent therapy, however, when administered in a continuous, nonpulsatile manner, LHRH analogs induce inhibition of gonadotropin secretion and suppression of testicular steroidogenesis. |
| List of Excipients |
|---|
|
PROSTAP 3 Powder: Poly (D-L lactic acid) Sterile Solvent: Carmellose sodium |
One dual chamber pre-filled syringe containing 11.25 mg leuprorelin acetate powder in the front chamber and 1 ml of Sterile Solvent in the rear chamber.
1 × 23 gauge syringe needle fitted with safety device.
1 x syringe plunger.
Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom
PL 16189/0013
28/04/2011
| Drug | Countries | |
|---|---|---|
| PROSTAP | Ireland, United Kingdom |
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