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Directions for Reconstitution
Two-vial package: Withdraw sterile air from lyophilized vial and inject into diluent vial. Remove 1–10 mL from diluent and add to lyophilized vial; agitate gently until powder is completely dissolved in solution.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
IMPORTANT: USE COMPLETELY AFTER RECONSTITUTION. RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED.
HOW SUPPLIED
Two-vial package containing:
1-10 mL lyophilized multiple dose vial containing: 10,000 USP Units chorionic gonadotropin per vial, NDC 0052-0315-10.
1-10 mL vial of solvent containing: water for injection with sodium chloride 0.56% and benzyl alcohol 0.9%, NDC 0052-0325-10.
When reconstituted, each 10 mL vial contains:
Chorionic gonadotropin 10,000 USP Units
Monobasic sodium phosphate 5 mg
Dibasic sodium phosphate 4.4 mg
Sodium chloride 0.56%
Benzyl alcohol 0.9%
If required pH adjusted with sodium hydroxide and/or phosphoric acid.
Storage
Store at controlled room temperature 15–30°C (59–86°F). Reconstituted solution is stable for 60 days when refrigerated.