General Information
Revision date
2014-06-19
Product name
HYPER RHO S/D FULL DOSE, HYPER RHO S/D MINI-DOSE
Chemical name
Aqueous solu tion of human plasma proteins
1.2.1 Relevant identified uses
individuals who have been transfused with Rh o (D) positive red blood c ells ® Hyper RHO S/D Mini-Dose is used to prevent the isoimmmunization of the Rh o (D) negative women at the time of spontaneous or induced abortion up to 12 weeks’ gestation
Icons in SDS
Company Information
company name
Grifols Therapeutics In c
Section 2
SECTION 2: Hazards identification
(29 CFR 1910.1200) Globally Harmonized System of Classification and Labeling of Chemicals (GHS) ~Verified on 2014-07 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-07. ~ No hazards are expected from using this product. This p roduct 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 Intramuscular
Medical Conditions Generally Aggravated by Exposure
None known
Potential health effects
INHALATION: ACUTE (IMMEDIATE): None known CHRONIC (DELAYED): None kno wn 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 E FFECTS: None known CARCINOGENIC EFFECTS: None kno wn REPRODUCTIVE EFFECTS: None know n Page 2 of 6 HYPER RHO® S/D
Other Health Effects
This product is prepared 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 plasma donations have been tested for the absence of the HIV-1, Hepatitis C and Hepatitis B viruses using Polymera se Chain Reaction (PCR) technology. The product has also undergone s eparate 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
