Gamunex -C; IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10%

SECTION 2: Hazards identification

(29 CFR 1910.1200) Globally Harmonized System of Classification and Labeling of Chemicals (GHS) No hazards are expected from using this product. This product is not regulated under the United Nations Globally Harmonized System for the Classification and

EU Classification

The product is not regulated under European Directive 67/648/EEC

Principle Routes of Exposure

Accidental Eye contact, Skin contact, Ingestion; Appropriate route of entry Intravenous or subcutaneous.

Medical Conditions Generally Aggravated by Exposure

None known

Potential health effects

INHALATION: ACUTE (IMMEDIATE): None known CHRONIC (DELAYED): None known SKIN: ACUTE (IMMEDIATE): None known CHRONIC (DELAYED): None known EYE: ACUTE (IMMEDIATE): None known CHRONIC (DELAYED): None known INGESTION: ACUTE (IMMEDIATE): None known CHRONIC (DELAYED): None known MUTAGENIC EFFECTS: None known CARCINOGENIC EFFECTS: None known REPRODUCTIVE EFFECTS: None known

Other Health Effects

This product is prepared from pooled human plasma. Each plasma donation has been tested for the absence of antibodies against HIV-1, HIV-2 and Hepatitis C and the absence of surface antigens for Hepatitis B. Additionally, mini-pools of plasma donations have been tested for the absence of the HIV-1, Hepatitis C and Hepatitis B viruses using Polymerase Chain Reaction (PCR) technology. The product has also undergone separate manufacturing processes to remove and/or inactivate enveloped and non-enveloped viruses. However, as Page 2 of 6 GAMUNEX-C®; GAMUNEX®; IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% CAPRYLATE/CHROMATOGRAPHY PURIFIED(IGIV-C); IGIVNEX™ (CANADA) with all human derived products, the risk of infectivity due to known or yet unknown pathogens cannot be totally eliminated or ensured. See Section 12 for Ecological Information