GLAXO INC -- ZOFRAN  ONDANSETRON HYDROCHLORIDE  TABLETS  -- -
<pre>=====================  Product Identification  =====================

Product ID:ZOFRAN  ONDANSETRON HYDROCHLORIDE  TABLETS
MSDS Date:12/19/1994
FSC:NIIN:Submitter:F BT
Status Code:A
=== Responsible Party ===
Company Name:GLAXO INC
Address:5 MOORE DR
City:RESEARCH TRIANGLE PARK
State:NC
ZIP:27709
Country:US
Info Phone Num:919-248-2100/2700
Emergency Phone Num:919-248-2100
CAGE:34006
=== Contractor Identification ===
Company Name:GLAXO WELLCOME INC.
Address:5 MOORE DR
Box:13398
City:DURHAM
State:NC
ZIP:27709
Country:US
Phone:919-248-2100
CAGE:34006

=============  Composition/Information on Ingredients  =============

Ingred Name:ONDANSETRON HYDROCHLORIDE
CAS:103639-04-9

=====================  Hazards Identification  =====================

Routes of Entry: Inhalation:YES  Skin:NO  Ingestion:YES
Health Hazards Acute and Chronic:INHALATION: MAY CAUSE ALLERGIC
    SENSITIZATION. EYES: SEVERE IRRITANT. INGESTION: MAY RESULT IN A
    VARIETY OF ADVERSE EFFECTS. ZOFRAN TABLETS ARE INTENDED FOR MEDICAL
    USE TO PREVENT NAUSEA & VOMITING ASS OCIATED W/INITIAL & REPEATED
    COURSES OF CANCER CHEMOTHERAPY & ALSO WHEN ACCOMPANYING
    RADIOTHERAPY FOR CANCER.
Effects of Overexposure:IRRITATION, HEADACHE, SKIN RASH, CONSTIPATION,
    ABDOMINAL PAIN, WEAKNESS, CHANGES IN HEART RATE, ELECTROCARDIOGRAM,
    CHEST PAIN, DRY MOUTH, RARE BRONCHOSPASM, WHEEZING, ANAPHYLAXIS,
    SHORTNESS OF BREATH,  UNCONSCIOUSNESS, CONVULSIONS, SHOCK.
Medical Cond Aggravated by Exposure:INDIVIDUALS KNOWN TO BE
    HYPERSENITIVE TO ONDANSETRON HYDROCHLORIDE. PERSONS W/LIVER
    DISEASE.

=======================  First Aid Measures  =======================

First Aid:EYES: FLUSH W/LARGE AMOUNTS OF COOL WATER FOR 15 MINS. SKIN:
    WASH W/SOAP & WATER. INHALATION: IF NOT BREATHING, GIVE CPR/OXYGEN
    IF NECESSARY. INGESTION: IF AWAKE & ABLE TO SWALLOW, RINSE MOUTH
    W/WATER . NEVER GIVE ANYTHING BY MOUTH IF UNCONSCIOUS/HAVING
    CONVULSIONS. OBTAIN MEDICAL ATTENTION IN ALL CASES.

=====================  Fire Fighting Measures  =====================

Extinguishing Media:WATER SPRAY, MULTI-PURPOSE DRY CHEMICAL
Fire Fighting Procedures:WEAR FULL PROTECTIVE CLOTHING & USE SELF
    CONTAINED BREATHING APPARATUS.
Unusual Fire/Explosion Hazard:BREAKAGE OF TABLETS, IN BULK OPERATIONS,
    COULD CONTRIBUTE TO DUST FORMATION. AS W/ANY ORGANIC DUST, THERE IS
    POTENTIAL FOR EXPLOSION WHEN HIGH CONCENTRATIONS ARE SUSPENDED IN
    AIR.

==================  Accidental Release Measures  ==================

Spill Release Procedures:PROTECTIVE EQUIPMENT MAY BE NECESSARY. FOR
    SMALL QUANTITIES, COLLECT LEAK & TRANSFER TO A WASTE CONTAINER FOR
    DISPOSAL.  LARGE/BULK QUANTITIES, COLLECT BY CAREFULLY
    SWEEPING/WIPING  & PLACE IN A LABEL LED, SEALED CONTAINER FOR
    DISPOSAL. WASH AREA (FLOOR & OTHER CONTACT SURFACES) THOROUGHLY
    W/SOAP & WATER.

======================	Handling and Storage  ======================

Handling and Storage Precautions:STORE BETWEEN 36 & 86F. PROTECT FROM
    EXCESSIVE MOISTURE.

=============  Exposure Controls/Personal Protection  =============

Respiratory Protection:RESPIRATORY PROTECTIVE EQUIPMENT SHOULD BE WORN
    WHEN WORKERS ARE EXPOSED TO HIGH DUST LEVELS. RECOMMENDATIONS FOR
    RESPIRATOR SELECTIONS IS NIOSH (ANSI Z88.2.
Ventilation:PROVIDE GOOD GENERAL EXHAUST VENTILATION.
Protective Gloves:IMPERMEABLE/LATEX
Eye Protection:REQUIRED
Other Protective Equipment:PROTECTIVE CLOTHING
Work Hygienic Practices:REMOVE/LAUNDER CONTAMINATED CLOTHING & SHOES
    BEFORE REUSE. WORK SURFACES SHOULD BE PROPERLY CLEANED/DISPOSED OF
    AFTER USE.	A SUITABLE SOLVENT SUCH AS SOAP & WATER SHOULD BE USED
    FOR CLEANING.
Supplemental Safety and Health
WASH HANDS & OTHER AREAS OF SKIN CONTACT THOROUGHLY AFTER HANDLING THIS
    MATERIAL.

==================  Physical/Chemical Properties  ==================

Appearance and Odor:4 MG WHITE/8MG YELLOW, OVAL TABLET ENGRAVED W/"4" /
    "8" & GLAXO; ODORLESS

=================  Stability and Reactivity Data  =================

Stability Indicator/Materials to Avoid:YES
Hazardous Decomposition Products:THERMAL DECOMPOSITION OF ONDANSETRON
    HYDROCHLORIDE: OXIDES OF NITROGEN & HYDROCHLORIC ACID.

===================  Toxicological Information	===================

Toxicological Information:SOME PATIENTS (5%) TREATED INTRAVENOUSLY
    W/ZOFRAN WHILE ALSO TAKING ANTI-CANCER MEDICATION HAD BRIEF &
    REVERSIBLE ELEVATIONS IN THE CIRCULATING LEVEL OF TWO ENZYMES.
    THERE ARE REPORTS OF LIVER FAILURE	& DEATH IN CANCER PATIENTS
    RECEIVING ONDANSETRON IN COMBINATION W/TOXIC ANTICANCER DRUGS.
    WHETHER ZOFRAN CONTRIBUTED TO THIS PROBLEM IS UNCLEAR. THERE IS NO
    INDICATION THAT ONDANSETRON CAUSES CANCER/ MUTATION/BIRTH
    DEFECTS/OTHER REPRODUCTIVE HEALTH EFFECTS IN STANDARD TESTS. IN THE
    OCCUPATIONAL SETTING, EXPOSURE TO ZOFRAN TABLETS SHOULD BE
    MEDICALLY EVALUATED DURING PREGNANCY/NURSING.

====================  Disposal Considerations  ====================

Waste Disposal Methods:UNUSED PRODUCT SHOULD BE DISPOSED OF AT AN
    APPROVED FACILITY/DISPOSE OF IN ACCORDANCE W/LOCAL, STATE & FEDERAL
    REGULATIONS.

=======================  Other Information  =======================

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