How is ACAM2000supplied?
Dosage Forms And Strengths After reconstitution of the lyophilized preparation, each vial has approximately 100 doses of 0.0025 mL of vaccinia virus (live) containing 2.5-12.5x105 plaque forming units / dose. ACAM2000, Smallpox (Vaccinia) Vaccine, Live, is supplied in multiple-dose 3 mL clear glass vials containing lyophilized powder (freeze-dried vaccine). After reconstitution with 0.3 mL of diluent, the vial contains approximately 100 nominal doses of 0.0025 mL of vaccinia virus (live), 1.0 - 5.0x108 PFU/mL or 2.5-12.5x105 PFU/dose. Diluent for ACAM2000, 50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP in Water for Injection USP, is supplied in 3 mL clear glass vials containing 0.6 mL of diluent. Bifurcated needles are supplied in boxes (5 x 5 x 1 in) containing 100 needles. 1 mL tuberculin syringes with 25 gauge x 5/8” needles are supplied for vaccine reconstitution. Storage And Handling ACAM2000 should be stored in a freezer with an average temperature of -15°C to -25°C (+5°F to -13°F). Prior to reconstitution, ACAM2000 vaccine retains a potency of 1.0x108 PFU or higher per dose for at least 18 months when stored at refrigerated temperatures of +2-8°C (36-46°F). During shipment, ACAM2000 should be maintained at a temperature of -10°C or colder. After reconstitution, ACAM2000 vaccine may be administered during a 6 to 8 hour workday at room temperature (20-25°C, 68-77°F). Reconstituted ACAM2000 vaccine may be stored in a refrigerator (2-8°C, 36-46°F) no longer than 30 days, after which it should be discarded [See Vaccination Instructions]. Diluent for Smallpox Vaccine, (Vero Cells) Lyophilized, ACAM2000 should be stored at room temperature (15-30°C, 59-86°F). ACAM2000 contains live vaccinia virus that is transmissible, and should be handled as an infectious agent once vials are open. See [Instructions for Vaccine Preparation] and [Preparation / Handling Precautions and Instructions for Disposal] for details on handling and disposal. REFERENCES 1 Fulginiti VA, Papier A, Lane JM, Neff JM, Henderson, DA. Smallpox vaccination: a review, part 1. background, vaccination technique, normal vaccination and revaccination, and expected normal reactions. Clin Infect Dis. 2003;37:241-250. Sanofi Pasteur Biologics Co., 38 Sidney Street, Cambridge, MA 02139. Revised: October 2009 Last reviewed on RxList: 9/29/2014
This monograph has been modified to include the generic and brand name in many instances.