BRISTOL-MEYERS SQUIBB PHARMACEUTICAL GROUP -- PROHANCE FOR INJECTION -- 6505-01-371-4206
===================== Product Identification =====================
Product ID:PROHANCE FOR INJECTION
MSDS Date:01/20/1994
FSC:6505
NIIN:01-371-4206
Status Code:A
MSDS Number: CKLJG
=== Responsible Party ===
Company Name:BRISTOL-MEYERS SQUIBB PHARMACEUTICAL GROUP
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903
Country:US
Info Phone Num:908-519-3843
Emergency Phone Num:908-519-3843
Chemtrec Ind/Phone:(800)424-9300
CAGE:TO591
=== Contractor Identification ===
Company Name:BRISTOL-MEYERS SQUIBB PHARMACEUTICAL GROUP
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903
Country:US
Phone:908-519-3843
CAGE:TO591
============= Composition/Information on Ingredients =============
Ingred Name:GADOTERIDOL
CAS:120066-54-8
= Wt:24.
Ingred Name:WATER
CAS:7732-18-5
RTECS #:ZC0110000
Ingred Name:TROMETHAMINE
CAS:77-86-1
RTECS #:TY2900000
< Wt:1.
Ingred Name:CALTERIDOL CALCIUM
CAS:121915-83-1
< Wt:1.
===================== Hazards Identification =====================
LD50 LC50 Mixture:LD50 (RAT) > 5,880 MG/KG
Routes of Entry: Inhalation:NO Skin:NO Ingestion:NO
Reports of Carcinogenicity:NTP:NO IARC:NO OSHA:NO
Health Hazards Acute and Chronic:UNDER NORMAL CONDITIONS, THIS PRODUCT
IS CONTAINED WITHIN VIALS AND SKIN/EYE CONTACT OR INHALATION WOULD
NOT BE EXPECTED. PROHANCE FOR INJECTION CONTAINS GADOTERIDOL, A
CONTRAST AGENT IN MAGNETIC RES ONANCE IMAGING (MRI) INTENDED FOR
INTRAVENOUS INJECTION, UNDER THE CARE OF A PHYSICIAN. WHEN
ADMINISTERED PROPERLY, THIS PRODUCT CAN BE USED TO VISUALIZE SUBTLE
BRAIN LESIONS. NAUSEA AND TASTE CHANGES WERE REPORTED IN 1.4% OF
PATIENTS RECEIVING THIS INJECTION. ADVERSE CARDIOVASCULAR,
DIGESTIVE, NERVOUS SYSTEM, RESPIRATORY, DERMAL AND AUDITORY EFFECTS
WERE EXPERIENCED BY LESS THAN 1% OF PATIENTS.
Explanation of Carcinogenicity:NONE KNOWN.
Effects of Overexposure:NO INFORMATION.
Medical Cond Aggravated by Exposure:N/P.
======================= First Aid Measures =======================
First Aid:INGEST: SEEK MEDICAL ATTENTION IMMEDIATELY. INDUCTION OF
VOMITING SHOULD BE CONSIDERED FOR SIGNIFICANT INGESTION IF PERSON
IS CONSCIOUS AND NOT EXPERIENCING CONVULSIONS. NEVER GIVE ANYTHING
BY MOUTH T O AN UNCONSCIOUS PERSON. INHALE: REMOVE TO FRESH AIR. IF
PERSON IS NOT BREATHING GIVE ARTIFICIAL RESPIRATION. IF BREATHING
IS DIFFICULT ADMINISTER OXYGEN. SKIN: WASH WITH SOAP AND WATER. GET
MEDICAL A TTENTION IF IRRITATION DEVELOPS AND PERSISTS. EYE: HOLD
EYELIDS APART AND FLUSH WITH RUNNING WATER FOR AT LEAST 15 MINUTES.
GET MEDICAL ATTENTION IMMEDIATELY.
===================== Fire Fighting Measures =====================
Extinguishing Media:UNLIKELY TO BURN IN VIAL. IN CASE OF FIRE, FLOOD
WITH WATER.
Fire Fighting Procedures:FIREFIGHTERS SHOULD WEAR SELF-CONTAINED
BREATHING APPARATUS, FLAME AND CHEMICAL RESISTANT CLOTHING, BOOTS
AND GLOVES. EVACUATE WITH WATER FROM A MAXIMUM DISTANCE.
Unusual Fire/Explosion Hazard:NONE KNOWN.
================== Accidental Release Measures ==================
Spill Release Procedures:ABSORB SPILL WITH INERT MATERIAL, E.G., SAND,
VERMICULITE OR OTHER NON-COMBUSTIBLE ABSORBENT MATERIALS, AND PLACE
INTO A CLOSED CONTAINER FOR RECLAMATION OR DISPOSAL. FLUSH RESIDUAL
SPILL AREA WITH W ATER TO PROCESS SEWER IF ALLOWABLE UNDER
NATIONAL, STATE, OR LOCAL PERMITS OR REGULATIONS.
====================== Handling and Storage ======================
Handling and Storage Precautions:DO NOT BREAK VIALS. AVOID SKIN AND EYE
CONTACT. SHOULD BE STORED AT CONTROLLED ROOM TEMPERATURES (15 - 30
DEGREE C). DO NOT FREEZE.
============= Exposure Controls/Personal Protection =============
Respiratory Protection:WHEN ENGINEERING CONTROLS ARE NOT SUFFICIENT TO
CONTROL EXPOSURE, WEAR APPROVED RESPIRATORY PROTECTION APPROPRIATE
FOR EXPOSURE POTENTIAL; SELF-CONTAINED BREATHING APPARATUS SHOULD
BE AVAILABLE FOR EM ERGENCY USE.
Ventilation:NONE BEYOND GOOD ROOM VENTILATION NORMALLY REQUIRED.
Protective Gloves:IMPERVIOUS GLOVES.
Eye Protection:SAFETY GLASSES.
Other Protective Equipment:WEAR PROTECTIVE OVERALLS WHENEVER THE
POTENTIAL FOR SEVERE DUSTY CONDITIONS OR SPLASHING AND SPRAYING
LIQUIDS EXISTS.
Work Hygienic Practices:WASH HANDS AFTER HANDLING COMPOUNDS AND BEFORE
EATING, SMOKING, USING LAVATORY, AND AT THE END OF THE DAY.
Supplemental Safety and Health
================== Physical/Chemical Properties ==================
HCC:N1
Boiling Pt:=100.C, 212.F
Melt/Freeze Pt:=0.C, 32.F
Spec Gravity:1.14
Evaporation Rate & Reference:SAME AS WATER
Solubility in Water:ABOUT 620 MG/ML
Appearance and Odor:CLEAR, COLORLESS TO SLIGHTLY YELLOW AQUEOUS LIQUID
WHICK IS PACKAGED IN VIALS.
================= Stability and Reactivity Data =================
Stability Indicator/Materials to Avoid:YES
ACIDS.
Stability Condition to Avoid:WHEN STORED AT CONTROLLED ROOM
TEMPERATURES (15-30 DEGREE C) IN ORIGINAL CONTAINER, MATERIAL IS
STABLE TO EXPIRATION DATE SHOWN ON PRODUCT LABEL.
Hazardous Decomposition Products:OXIDES OF CARBON, AND OXIDES OF
NITROGEN.
=================== Toxicological Information ===================
Toxicological Information:IN LABORATORY ANIMALS, GADOTERIDOL WAS
ESSENTIALLY NONTOXIC WHEN ADMINISTERED BY THE INTRAVENOUS ROUTE. AT
DOSES, APPROXIMATELY 100 TIMES GREATER THAN THE CLINICAL DOSE,
EXPERIMENTAL ANIMALS EXHIBITED ATAXIA, CONVULSIONS, COLLAPSE,
IRREGULAR RESPIRATION. NO TREATMENT-RELATED PATHOLOGIC CHANGES
WERE SEEN IN SURVIVING ANIMALS.
===================== Ecological Information =====================
Ecological:DAPHNIA ACUTE TOXICITY (EC50) > 920 MG/L. CHEMICAL FATE
INFORMATION: HALF-LIFE 9HYDROLYSIS): < 10% HYDROLYSIS AFTER 5 DAYS
AT 50 DEGREES C AT ALL PH LEVELS TESTED; CONSIDERED HYDROLYTICALLY
STABLE. AE ROBIC BIODEGRADATION: HALF-LIFE DETERMINED TO BE GREATER
THAN 28 DAYS.
==================== Disposal Considerations ====================
Waste Disposal Methods:DISPOSE OF IN ACCORDANCE WITH NATIONAL, STATE,
LOCAL OR APPLICABLE COUNTRY REGULATIONS.
=================== MSDS Transport Information ===================
Transport Information:DOT: NOT REGULATED.
===================== Regulatory Information =====================
SARA Title III Information:NONE NOTES
Federal Regulatory Information:NONE NOTED
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.