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Each Lyophilized vial contains: Leuprorelin BP (as acetate) 3.75 mg, Excipients q.s.
Diluent Composition: Each ampoule contains Carboxymethyl cellulose, Sodium USNF 5.0 mg, D-Mannitol USP 50 mg, Polysorbate 80 USNF 1 mg, Glacial Acetic Acid USP (for pH adjustment) q.s., Water for Injection USP q.s. to 2 ml.
Leuprorelin acetate is a synthetic nonapeptide analogue of naturally occurring gonadotropin releasing hormone (GnRH or LhRH). It possesses greater potency than the natural hormone. Prolide is a formulation of leuprorelin acetate. Each lyophilized vial containing microspheres, when mixed with diluents becomes a suspension.
Leuprorelin acetate suspension is administered as an intramuscular or subcutaneous injection once in a month or every 3 months.
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