Enantone 1-Month DPS 3.75 mg/Enantone 3-Month DPS 11.25 mg/Enantone 6-Month DPS 30 mg Description

Leuprorelin Acetate occurs as a white to yellowish white powder. It is freely soluble in water and acetic acid (100), soluble in methanol and ethanol (95), slightly soluble in ethanol (99.5) and sparingly soluble in acetonitrile. It is hygroscopic.
Structural formula (amino acids sequence): 5-oxo-Pro-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NH-CH₂-CH₃·CH₃COOH.
Chemical name: 5-Oxo-prolyl-histidyl-tryptophyl-seryl-tyrosyl-D-leucyl-leucyl-arginyl-N-ethyl-prolinamide monoacetate.
Molecular formula: C₅₉H₈₄N₁₆O₁₂ · C₂H₄O₂.
Molecular weight: 1269.45.
Enantone 1-Month DPS 3.75 mg: ENANTONE is a white lyophilizate supplied in a dual chamber pre-filled syringe as shown as follows: See Table 1.

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It consists of powder part and liquid part (1 ml vehicle for suspension). One ml of vehicle for suspension contains water for injection, and 50 mg of mannitol, 5 mg of carmellose sodium, and 1 mg of polysorbate 80 as inactive ingredients.
ENANTONE, when suspended with 1 ml of the attached vehicle for suspension, shows a pH value of 6.0 - 7.5 and an osmotic pressure ratio (relative to isotonic sodium chloride solution) of about 1.
Enantone 3-Month DPS 11.25 mg: White powder and clear, colourless solvent for suspension for injection.
One prefilled syringe contains leuprorelin acetate 11.25 mg.
Excipient with known effects: sodium.
Excipients/Inactive Ingredients: Powder: polylactic acid, mannitol.
Solvent: mannitol, sodium carmellose, polysorbate 80, water for injection.
Enantone 6-Month DPS 30 mg: Each dual chamber pre-filled syringe containing 352.9 mg sustained-release microcapsules and 1 ml suspension medium contains: 30.0 mg leuprorelin acetate, equivalent to 28.58 mg leuprorelin.
Excipients with known effect: one dual chamber pre-filled syringe contains 5.0 mg carmellose sodium.
Excipients/Inactive Ingredients: Sustained-release microcapsules: Poly (D,L-lactic acid) 270 mg, Mannitol (Ph. Eur.).
Suspension medium: Mannitol (Ph. Eur.), Carmellose sodium, Polysorbate 80, Acetic acid 99 % (to adjust the pH-value), Water for injections.