General Information
Revision date
2020-04-14
Product name
Gammaked; ImMunE Globulin IntRAVEnous (HumAN), 10% CAPRYLATE/CHROMATOGRAPHY PURIFIED (IGIV-C)
Product name
Gammaked; ImMunE Globulin IntRAVEnous (HumAN), 10% CAPRYLATE/CHROMATOGRAPHY PURIFIED (IGIV-C)
Identification on the label/Trade name
Gammaked ; IMMUNE GLOBULIN INTRAVEN
Chemical name
Aqueous solution of human plasma proteins
1.2.1 Relevant identified uses
Polyneuropathy, and Idiopathic Thrombocytop enic Purpura: Primary and Secondary Immune Deficiency Syndome(s) including Allogenic Bone Marrow Transplantation and Pediatric HIV Infection
Manufacturer Name
GRIFOLS THERAPE
Icons in SDS
Company Information
company name
GRIFOLS THERAPEUTICS, LLC.
Section 2
SECTION 2: Hazards identification
29 CFR 1910.1200) Globally Harmonized System of Classification and Labeling of Chemicals (GHS) No ha zards are expected from using this product. This product is not regulated under the United Nati ons Globally Harmonized System for the Classification and Labeling of Hazardous Chemicals (GHS) 2006 version; European Directive 67/648/EEC; and U.S
EU Classification
The pr oduct is not regulated under European Directive 67/648/EEC. O SHA CLASSIFICATION The product is not regulated under U.S.
Medical Conditions Generally Aggravated by Exposure
None known P OTENTIAL EALTH EFFECTS: H I NHALATION ACUTE (IMMEDIATE): None know n C HRONIC (DELA YED ): None kno wn SKIN: ACUTE (IMMEDIATE): None known C HRONIC (DELAYED): None known EYE: ACUTE (IMMEDIATE): None known C HRONIC (D ELAYED ): None known INGESTION: ACUTE (IMMEDIATE): None known CHRONIC (DELAYED): None known MUTAGENIC EFFECTS: None known C ARCINOGENIC FFECTS E : None kno wn R EPRO DUCTIVE FFECTS E : None know n O THER EALTH FFECTS H E : This product is prepa red from pooled human plasma. Each plasma donation has been tested for the absence of antibodies ag ainst HIV-1, HIV-2 and Hepatitis C and the absence of surface antigens for H epatitis B. Additionally, mini-pools of pl asma 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 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 Page 2 of 6 GAMMAKED®; IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% CAPRYLATE/CHROMATOGRAPHY PURIFIED (IGIV- C)
