Product ID:H-BIG HEPATITIS B IMMUNE GLOBULIN HUMAN
MSDS Date:05/01/1993
FSC:6550
NIIN:00F040483
MSDS Number: BXLRQ

NORTH AMERICAN BIOLOGICALS INC

16500 NW 15TH AVE
MIAMI, FL 33169-5620
US

Emergency Phone: 305-625-5303

Info Phone: 305-625-5303

Cage: 2S857

NORTH AMERICAN BIOLOGICALS INC

MIAMI, FL 33169-5620 US

Telephone: 305-625-5303

Cage: 2S857

ANTIBODIES TO HEPATITIS B

GLYCINE; AMINOACETIC ACID; GLYCOLIXIR; HAMPSHIRE GLYCINE

CAS: 56-40-6

RTECS: MB7600000

THIMEROSAL, ETHYLMERCURITHIOSALICYCIC ACID, SODIUM SOLUTION

CAS: 54-64-8

RTECS: OV8400000

Fraction By Weight: 0.01%

OSHA PEL 0.01 MG/CUM

ACGIH TLV: 0.1 MG/CUM

Routes of Entry: Inhalation:NO Skin:NO Ingestion:NO
Reports of Carcinogenicity:NTP:NO IARC:NO OSHA:NO
Health Hazards Acute and Chronic:THIS PRODUCT IS A PURIFIED ANTIBODY
PREPARATION USED FOR HUMAN INJECTION TO INDUCE TEMPORARY IMMUNITY
TO HEPATITIS B. THE PRODUCT IS DERIVED FROM HUMAN PLASMA WHICH HAS
TESTED POSITIVE FOR ANTIBODIES TO HEPATITIS B. PRODUCT IS PRODUCED
BY ISOLATION OF THE ANTIBODIES USING ETHANOL FRACTIONATION. (SEE
SUPP)
Explanation of Carcinogenicity:NONE
Effects of Overexposure:THIS PRODUCT IS A PURIFIED ANTIBODY PREPARATION
USED FOR HUMAN INJECTION TO INDUCE TEMPORARY IMMUNITY TO HEPATITIS
B. PRODUCT IS DERIVED FROM HUMAN PLASMA WHICH HAS TESTED POSITIVE
FOR ANTIBODIES TO H EPATITIS B. PRODUCT IS PRODUCED BY ISOLATION OF
THE ANTIBODIES USING ETHANOL FRACTIONATION. (SEE SUPP)

First Aid:SKIN: WASH AREA W/SOAP & WATER. OBTAIN MEDICAL ATTENTION IN
ALL CASES.

Unusual Fire/Explosion Hazard:PRODUCT IS NEITHER FLAMMABLE NOR
EXPLOSIVE.

Spill Release Procedures:COLLECT/ABSORB ONTO INERT MATERIAL. PLACE IN
SUITABLE CONTAINER FOR PROMPT DISPOSAL. AREA SHOULD BE CLEANED
W/DILUTE (1 IN10) HOUSEHOLD BLEACH 0.5% SODIUM HYPOCHLORITE).

Handling and Storage Precautions:OPERATORS MAY WISH TO USE SAFETY
PIPETTE DEVICES, VIRAL DISINFECTING SOA FOR CLEANING. REASONABLE
PRECAUTIONS SHOULD BE TAKEN TO MINIMIZE CONTACT.
Other Precautions:AVOID CONTACT W/OPEN SKIN. THE HUMAN PLASMA HAS BEEN
TESTED & FOUND POSITIVE FOR ANTIBODIES TO HEPATITIS B. ETHANOL
FRACTIONATION TREATMENT IS KNOWN TO INACTIVATE HEPATITIS B VIRUS.
EMERGING VIRUSES M AY NOT BE INACTIVATED BY THIS TREATMENT.

Respiratory Protection:NONE
Ventilation:NONE
Protective Gloves:LATEX, VINYL
Eye Protection:NONE
Other Protective Equipment:DISPOSABLE
Work Hygienic Practices:WASH THOROUGHLY AFTER HANDLING.
Supplemental Safety and Health
HEALTH HAZARDS CONT'D: THIS PROCESS IS DOCUMENTED TO PROVIDE VIRAL
INACTIVATION. THE ANTIBODY IS SUSPENDED IN AN AQUEOUS SOLUTION
WHICH CONTAINS A STABILIZER (GLYCINE) & A PRESERVATIVE
(THIMEROSAL).

Boiling Pt:B.P. Text:215.6F
Vapor Pres:25
Solubility in Water:COMPLETE
Appearance and Odor:SLIGHTLY OPALESCENT LIQUID

Stability Indicator/Materials to Avoid:YES
Stability Condition to Avoid:MIXTURE REACTS W/WATER WHICH COMPRISES 85%
OF THE PRODUCT.

Waste Disposal Methods:DISPOSE OF IAW/FEDERAL, STATE & LOCAL
REGULATIONS. DISPOSE IN AN APPROVED WASTE DISPOSAL FACILITY.

Disclaimer (provided with this information by the compiling agencies):
This information is formulated for use by elements of the Department
of Defense. The United States of America in no manner whatsoever,
expressly or implied, warrants this information to be accurate and
disclaims all liability for its use. Any person utilizing this
document should seek competent professional advice to verify and
assume responsibility for the suitability of this information to their
particular situation.