BWJRB - DYNAPEN FOR ORAL SUSPENSION

Product Identification

Product ID:DYNAPEN FOR ORAL SUSPENSION
MSDS Date:11/06/1992
FSC:6505
NIIN:00F037687
MSDS Number: BWJRB

Responsible Party
BRISTOL-MYERS SQUIBB, PHARMACEUTICAL GRP
5 GORDIS RD BLDG 124
NEW BRUNSWICK, NJ 08903-5000
US

Emergency Phone: 908-519-2385/609-921-4081

Info Phone: 800-332-2056/908-519-2385

Preparer: DR. E HAYES

Cage: BRIST

Contractor
E R SQUIBB MEDATOPE DIV
191 NEW BRUNSWICK, NJ 08903 US

Telephone: 609-921-4081

Cage: 4T649

Ingredients

NATURAL ORANGE FLAVOR

Fraction By Weight: <1%


NATURAL AND ARTIFICIAL ANTIBIOTIC FLAVOR

Fraction By Weight: <1%


ARTIFICIAL PINEAPPLE FLAVOR

Fraction By Weight: <1%


DICLOXACILLIN SODIUM MONOHYDRATE

CAS: 13412-64-1

RTECS: XH8925000

Fraction By Weight: 2%


SUCROSE

CAS: 57-50-1

RTECS: WN6500000

Fraction By Weight: >1%

OSHA PEL 15 MG/CUM DUST

ACGIH TLV: 10 MG/CUM


CLAY (KAOLIN), ALUMINUM SILICATE

CAS: 1332-58-7

RTECS: GF1670500

Fraction By Weight: >1%

OSHA PEL 10 MG/CUM DUST

ACGIH TLV: 10 MG/CUM TOTAL DUST


AVICEL-RC-591

Fraction By Weight: >1%


SODIUM CHLORIDE

CAS: 7647-14-5

RTECS: VZ4725000

Fraction By Weight: >1%


F.D.C. RED #40

Fraction By Weight: >1%


SODIUM CITRATE

CAS: 144-33-2

RTECS: GE7580000

Fraction By Weight: >1%


SODIUM SACCHARINE, SODIUM SACCHARIN (SUSPECTED ANIMAL CARC

CAS: 128-44-9

RTECS: DE4550000

Fraction By Weight: <1%


SODIUM BENZOATE

CAS: 532-32-1

RTECS: DH6650000

Fraction By Weight: <1.0%


ARTIFICIAL ORANGE-PINEAPPLE FLAVOR

Fraction By Weight: <1%

Hazards

LD50 LC50 Mixture:ORAL LD50(RAT): 3579 MG/KG (SEE SUPP)
Routes of Entry: Inhalation:NO Skin:NO Ingestion:YES
Reports of Carcinogenicity:NTP:NO IARC:YES OSHA:NO
Health Hazards Acute and Chronic:INGESTION: 35-76% OF DICLOXACILLIN
SODIUM MAY BE ABSORBED FROM THE GI TRACT. HYPERSENSITIVITY
REACTIONS MAY OCCUR. ANAPHYLAXIS HAS BEEN RARELY REPORTED
W/PENICILLINASE-RESISTANT PENICILLINS. MAY PROD UCE ADVERSE
HEMATOLOGIC EFFECTS; LEUKOPENIA/NEUTROPENIA, HEMORHAGIC COLITIS &
ASYMPTOMATIC HEPATIC EFFECTS. (SEE SUPP)
Explanation of Carcinogenicity:SEE INGREDIENTS.
Effects of Overexposure:RASH, WHEEZING, FEVER, EOSINOPHILIA, PRURITUS,
CHILLS, MYALGIA, NAUSEA, VOMITING, EPIGASTRIC DISTRESS, LOOSE
STOOLS, DIARRHEA, FLATULENCE, BLEEDING, IRRITATION, SNEEZING,
TEARING, REDNESS, SWELLING
Medical Cond Aggravated by Exposure:HYPERSENSITIVITY TO ANY
PENICILLIN/CEPHALOSPORIN. MAY AGGRAVATE GI DISEASE, HEPATIC
DISORDERS, HEMATOLOGIC DISORDERS & RENAL DISORDERS.

First Aid

First Aid:EYES: FLUSH W/PLENTY OF WATER FOR 15-20 MINS. SKIN: WASH
W/SOAP & WATER FOR 15-20 MINS. INHALATION: REMOVE TO FRESH AIR; IF
DIFFICULTY BREATHING, ADMINISTER OXYGEN/CPR IF NECESSARY. OBTAIN
MEDICAL ATT ENTION IN ALL CASES.

Fire Fighting

Extinguishing Media:WATER
Fire Fighting Procedures:EVACUATE PERSONNEL. USE A SCBA & PROTECTIVE
CLOTHING. USE WATER TO KEEP FIRE EXPOSED CONTAINERS COOL FROM A
SAFE DISTANCE/USE AN UNMANNED MONITOR. (SEE SUPP)
Unusual Fire/Explosion Hazard:FINE DUST SUSPENDED IN AIR IN SUFFICIENT
CONCENTRATION & IN THE PRESENCE OF AN IGNITION SOURCE MAY POSE A
POTENTIAL EXPLOSION HAZARD.

Accidental Release

Spill Release Procedures:WEARING SUITABLE PROTECTIVE CLOTHING, SWEEP
MATERIAL ONTO PAPER & PLACE INTO A FIBER DRUM FOR DISPOSAL. USE
LATEX GLOVES, EYE PROTECTION, NIOSH APPROVED DUST/MIST RESPIRATOR.
VENTILATE AREA & DECONTA MINATE AFTER MATERIAL HAS BEEN PICKED UP.

Handling

Handling and Storage Precautions:STORE IN TIGHT CONTAINER, AT A TEMP
<104F; BETWEEN 50-86F.
Other Precautions:THERAPEUTIC AGENTS ARE INTENDED FOR USE UNDER
DIRECTION OF A PHYSICIAN/UNDER THE CONDITIONS OF USE DESCRIBED ON
THE LABEL. AVOID CONTACT BY INGESTION, INHALATION, SKIN & EYES
W/THESE SUBSTANCES.

Exposure Controls

Respiratory Protection:USE A NIOSH APPROVED DUST/MIST RESPIRATOR.
Ventilation:RECOMMENDED.
Protective Gloves:RECOMMENDED
Eye Protection:GOGGLES
Other Protective Equipment:PROTECTIVE CLOTHING.
Work Hygienic Practices:REMOVE/LAUNDER CONTAMINATED CLOTHING BEFORE
REUSE. WASH HANDS & FACE AFTER HANDLING.
Supplemental Safety and Health
SOLUBILITY: WHEN MIXED W/WATER, PART OF THE FORMULATION WILL DISSOLVE &
PART WILL FORM A SUSPENSION. SPEC FIRE PROC: MOVE CONTAINERS FROM
FIRE AREA SAFELY. DIVERT RUNOFF TO A SAFE AREA. ORAL LD50: DIC
LOXACILLIN SODIUM. HEALTH HAZARDS CONT'D: PENICILLINS; MAY CAUSE
ALLERGIC SKIN & RESPIRATORY REACTIONS/IRRITATION.

Chemical Properties

Solubility in Water:(SEE SUPP)
Appearance and Odor:GRANULAR POWDER W/ORANGE-PINEAPPLE ODOR.

Stability

Stability Indicator/Materials to Avoid:YES
Stability Condition to Avoid:ELEVATED TEMPS.
Hazardous Decomposition Products:CO, CO2, HYDROGEN CHLORIDE, NITROGEN
OXIDES, SULFUR OXIDES.

Disposal

Waste Disposal Methods:DISPOSE OF IN ACCORDANCE W/LOCAL, STATE &
FEDERAL REGULATIONS.

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.