Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: AbbVie (Pty) Ltd, Abbott Place, 219 Golf Club Terrace, Constantia Kloof, 1709
LUCRIN DEPOT 3,75 Lyophilised microspheres for injection.
LUCRIN DEPOT DILUENT Sterile diluent for injection.
| Pharmaceutical Form |
|---|
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LUCRIN DEPOT 3,75 Lyophilised microspheres for injection. LUCRIN DEPOT DILUENT Sterile diluent for injection. |
LUCRIN DEPOT 3,75: Each single-dose vial contains leuprolide acetate 3,75 mg.
Contains mannitol (sugar-alcohol).
For full lists of excipients, see section 6.1.
LUCRIN DEPOT DILUENT: Each 2 mL ampoule of diluent for injection contains mannitol, polysorbate 80, sodium carboxymethylcellulose and water for injection.
Contains mannitol (sugar-alcohol).
| 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 |
|---|
|
LUCRIN DEPOT 3,75 Lyophilised microspheres for injection: Copoly (DL-Lactic acid/glycolic acid) (PLGA) |
LUCRIN DEPOT 3,75 is available in a single dose administration kit containing one vial of sterile lyophilised microspheres of leuprolide acetate (3,75 mg); one ampoule of diluent, one syringe with two 22-gauge needles and one alcohol swab.
LUCRIN DEPOT 3,75 is a white powder. The sterile liquid for reconstitution is a clear, colourless liquid. After reconstitution the suspension should appear milky.
AbbVie (Pty) Ltd, Abbott Place, 219 Golf Club Terrace, Constantia Kloof, 1709
LUCRIN DEPOT 3,75: 27/21.10/0370
LUCRIN DEPOT DILUENT: 27/34/0371
05/07/1993
| Drug | Countries | |
|---|---|---|
| LUCRIN | Australia, Israel, Mexico, Netherlands, New Zealand, Poland, Singapore, Turkey, South Africa |
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