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ENANTONE L.P. 3.75 mg/11.25 mg/30 mg is a sterile, lyophilized, white, odorless PLA (poly DL-lactic acid) microsphere powder for subcutaneous or intramuscular injection after reconstitution with the sterile vehicle to provide a 1 month (3.75 mg)/3 month (11.25 mg)/6 month (30 mg) depot injection.
For Dual Chamber Pre-filled Syringe (DPS) with a needle (25 G for 3.75 mg/23 G for 11.25 mg and 30 mg): Each DPS contains 3.75 mg/11.25 mg/30 mg leuprorelin acetate, respectively, and 1 ml sterile vehicle. The DPS is a dual chamber syringe with white powder in the front chamber and clear, colorless fluid in the rear chamber.
Excipients/Inactive Ingredients: 3.75 mg: PLGA-W [CoPoly (DL-Lactic acid/Glycolic acid) 75:25 mol%], Mannitol, Methylene Chloride, Polyvinyl Alcohol, Water for injection, Carboxymethylcellulose Sodium and Polysorbate 80.
11.25 mg: Polylactic acid, Mannitol, Methylene Chloride, Polyvinyl Alcohol, Carboxymethylcellulose Sodium, Polysorbate 80 and Water for injection.
30 mg: PLA(6M), Mannitol, Water for injections, Methylene Chloride, Polyvinyl Alcohol, Glacial Acetic Acid, CMC-Na, Polysorbate 80 and Nitrogen.
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