STERLING WINTHROP SANOFI WINTH -- LEVOPHED BITARTRATE INJECTION ======================================================= MSDS Safety Information ======================================================= FSC: 6810 MSDS Date: 05/06/1993 MSDS Num: BZVNH LIIN: 00F049179 Product ID: LEVOPHED BITARTRATE INJECTION MFN: 01 Responsible Party Cage: GO573 Name: STERLING WINTHROP INC SANOFI WINTHROP PHARMACEU Address: 90 PARK AVE City: NEW YORK NY 10016-1302 Info Phone Number: 212-907-2000/800-223-5511 Emergency Phone Number: 212-907-2000/800-223-5511 Review Ind: Y Published: Y ======================================================= Preparer Co. when other than Responsible Party Co. ======================================================= Cage: GO573 Assigned Ind: Y Name: STERLING WINTHROP INC SANOFI WINTHROP PHARMACEU Address: 90 PARK AVE City: NEW YORK NY 10016-1302 ======================================================= Contractor Summary ======================================================= Cage: GO573 Name: STERLING WINTHROP INC SANOFI WINTHROP PHARMACEU Address: 90 PARK AVE City: NEW YORK NY 10016-1302 Phone: 212-907-2000/800-223-5511 Cage: 63240 Name: WINTHROP PHARMACEUTICALS Address: 90 PARK AVE City: NEW YORK NY 10156 Phone: 212-907-2000 ======================================================= Ingredients ======================================================= Cas: 51-40-1 Name: LEVOPHED BITARTRATE ======================================================= Health Hazards Data ======================================================= Route Of Entry Inds - Inhalation: NO Skin: NO Ingestion: NO Carcinogenicity Inds - NTP: NO IARC: NO OSHA: NO Effects of Exposure: THIS IS A PHARMACEUTICAL MATERIAL AVAILABLE ONLY W/A PRESCRIPTION. USE ONLY AS DIRECTED. OVERDOSE MAY CAUSE ADVERSE CARDIOVASCULAR SYSTEM, NERVOUS SYSTEM, RESPIRATORY SYSTEM EFFECTS. Explanation Of Carcinogenicity: NONE Signs And Symptions Of Overexposure: OVERDOSE: HEADACHE. BODY AS A WHOLE: ISCHEMIC INJURY DUE TO POTENT VASOCONTRICTOR ACTION & TISSUE HYPOXIA. CARDIOVASCULAR SYSTEM: BRADYCARDIA, RISE IN BLOOD PRESSURE, ARRHYTHMIAS. NERVOUS SYSTEM: ANXI ETY, HEADACHE. RESPIRATORY SYSTEM: RESPIRATORY DIFFICULTY. First Aid: EYES: FLUSH W/WATER FOR 15 MINS. SKIN: WASH W/SOAP & WATER. OBTAIN MEDICAL ATTENTION IN ALL CASES. ======================================================= Handling and Disposal ======================================================= Spill Release Procedures: CONTAIN BY PLACING PAPER TOWELS/SUITABLE ABSORBENT MATERIAL AROUND THE EDGES OF SPILL & WORK INWARD. CAREFULLY SCOOP UP INTO PROPERLY LABELED CONTAINER FOR DISPOSAL. WASH AREA TO REMOV FROM SURFACES. Waste Disposal Methods: DISPOSE OF IAW/FEDERAL, STATE & LOCAL REGULATIONS. Other Precautions: KEEP THIS & ALL DRUGS OUT OF REACH OF CHILDREN. AVOID EYE CONTACT. ======================================================= Fire and Explosion Hazard Information ======================================================= Extinguishing Media: USE MEDIA APPROPRIATE FOR SURROUNDING AREAS. Fire Fighting Procedures: USE NORMAL FIRE FIGHTING GEAR. ======================================================= Control Measures ======================================================= Ventilation: NORMAL VENTILATION Eye Protection: NONE NORMALLY REQUIRED Work Hygienic Practices: USE GOOD PERSONAL HYGIENE. WASH THOROUGHLY W/SOAP & WATER AFTER USE. ======================================================= Physical/Chemical Properties ======================================================= Appearance and Odor: COLORLESS LIQUID ======================================================= Reactivity Data ======================================================= Stability Indicator: YES Hazardous Polymerization Indicator: NO ======================================================= Toxicological Information ======================================================= ======================================================= Ecological Information ======================================================= ======================================================= MSDS Transport Information ======================================================= ======================================================= Regulatory Information ======================================================= ======================================================= Other Information ======================================================= ======================================================= HAZCOM Label ======================================================= Product ID: LEVOPHED BITARTRATE INJECTION Cage: GO573 Assigned IND: Y Company Name: STERLING WINTHROP INC SANOFI WINTHROP PHARMACEU Street: 90 PARK AVE City: NEW YORK NY Zipcode: 10016-1302 Health Emergency Phone: 212-907-2000/800-223-5511 Label Required IND: Y Date Of Label Review: 12/16/1998 Status Code: C Label Date: 12/16/1998 Origination Code: G Hazard And Precautions: THIS IS A PHARMACEUTICAL MATERIAL AVAILABLE ONLY W/A PRESCRIPTION. USE ONLY AS DIRECTED. OVERDOSE MAY CAUSE ADVERSE CARDIOVASCULAR SYSTEM, NERVOUS SYSTEM, RESPIRATORY SYSTEM EFFECTS. OVERDOSE: HEADACHE. BODY AS A WHOLE: ISCHEMIC INJURY DUE TO POTENT VASOCONTRICTOR ACTION & TISSUE HYPOXIA. CARDIOVASCULAR SYSTEM: BRADYCAR DIA, RISE IN BLOOD PRESSURE, ARRHYTHMIAS. NERVOUS SYSTEM: ANXIETY, HEADACHE. RESPIRATORY SYSTEM: RESPIRATORY DIFFICULTY. ======================================================= 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, states, or intends said information to have any application, use or viability by or to any person or persons outside the Department of Defense nor any person or persons contracting with any instrumentality of the United States of America and disclaims all liability for such use. Any person utilizing this instruction who is not a military or civilian employee of the United States of America should seek competent professional advice to verify and assume responsibility for the suitability of this information to their particular situation regardless of similarity to a corresponding Department of Defense or other government situation.