PROSTAP 3 DCS Powder and solvent for suspension for injection in pre-filled syringe Ref.[7249] Active ingredients: Leuprorelin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom

Product name and form

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.

Qualitative and quantitative composition

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)
Mannitol (E421)

Sterile Solvent:

Carmellose sodium
Mannitol (E421)
Polysorbate 80
Acetic acid, glacial
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom

Marketing authorization dates and numbers

PL 16189/0013

28/04/2011

Drugs

Drug Countries
PROSTAP Ireland, United Kingdom

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