Source: FDA, National Drug Code (US) Revision Year: 2018
ACAM2000, Smallpox (Vaccinia) Vaccine, Live, is a live vaccinia virus derived from plaque purification cloning from Dryvax (Wyeth Laboratories, Marietta, PA, calf lymph vaccine, New York City Board of Health Strain) and grown in African Green Monkey kidney (Vero) cells and tested to be free of adventitious agents.
ACAM2000 is provided as a lyophilized preparation of purified live virus containing the following non-active excipients: 6-8 mM HEPES (pH 6.5-7.5), 2% human serum albumin USP, 0.5-0.7% sodium chloride USP, 5% mannitol USP, and trace amounts of neomycin and polymyxin B.
Diluent for ACAM2000 contains 50% (v/v) Glycerin USP, 0.25% (v/v) Phenol USP in Water for Injection USP, supplied in 3 mL clear glass vials containing 0.6 mL of diluent.
After reconstitution, each vial of ACAM2000 vaccine contains approximately 100 doses (0.0025 mL/dose). The concentration of vaccinia virus is 1.0‑5.0 × 108 plaque-forming units (PFU)/mL or 2.5-12.5 × 105 PFU/dose determined by plaque assay in Vero cells. ACAM2000 is administered by the percutaneous route (scarification) using 15 jabs of a stainless steel bifurcated needle that has been dipped into the vaccine.
| 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 2.5-12.5 × 105 plaque forming units/dose. |
| How Supplied |
|---|
|
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), 1.0-5.0 × 108 PFU/mL or 2.5-12.5 × 105 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 × 5 × 1 in) containing 100 needles. 1 mL tuberculin syringes with 25 gauge x 5/8" needles are supplied for vaccine reconstitution. Both the vaccine and diluent vial stoppers are not made with natural rubber latex. Manufactured by: Emergent Product Development Gaithersburg Inc., Gaithersburg, MD, USA 20879 |
| Drug | Countries | |
|---|---|---|
| ACAM2000 | Singapore, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
