MedPath
HSA Product

ACAM2000

Product approved by Health Sciences Authority (SG)

Basic Information

ACAM2000

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Regulatory Information

SIN13748P

December 28, 2009

Prescription Only

Therapeutic

PERCUTANEOUS

August 10, 2023

June 3, 2025

XJ07BX

Company Information

EMERGENT SALES AND MARKETING SINGAPORE PTE. LTD.

EMERGENT SALES AND MARKETING SINGAPORE PTE. LTD.

Active Ingredients

LIVE VACCINA VIRUS

Strength: 1.0 x10⁸ - 5.0 x10⁸ PFU/ml

Detailed Information

Contraindications

**4 CONTRAINDICATIONS** There are very few absolute contraindications to this vaccine for those who are at high risk for smallpox. The risk for experiencing serious vaccination complications must be weighed against the risks for experiencing a potentially fatal smallpox infection. See Warnings and Precautions (5) for persons who are at higher risk of experiencing serious vaccination complications – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **Severe Immune Deficiency** Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems. Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000. These individuals may include individuals who are undergoing bone marrow transplantation or individuals with primary or acquired immunodeficiency who require isolation.

Indication Information

**1 INDICATIONS AND USAGE** ACAM2000 is indicated for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. ACAM2000 should be used in accordance with official recommendations.

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