MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Ondansetron Hydrochloride Solution for InjectionTrade Name:Ondansetron InjectionChemical Family:MixtureIntended Use:Pharmaceutical product for the treatment of nausea and vomiting (antiemetic)2. HAZARDS IDENTIFICATIONA ppearance:Colorless solutionStatement of Hazard:Non-hazardous in accordance with international standards for workplace Hazard Information:Short Term:Active ingredient may be harmful if swallowed. May cause eye irritation (based oncomponents) .Long Term:May cause effects on central nervous system through prolonged or repeated Clinical Effects:Adverse effects associated with therapeutic use include headache, flushing, and Indication of danger:Not classifiedAustralian Hazard Classification(NOHSC):Non-Hazardous Substance.

2 Non-Dangerous :This document has been prepared in accordance with standards for workplace SAFETY , whichrequire the inclusion of all known hazards of the active substance or its intermediatesregardless of the potential risk. The precautionary statements and warnings included may notapply in all cases. Your needs may vary depending upon the potential for exposure in COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS List EU Classification%Ondansetron hydrochloride dihydrate103639-04-9 Not listedT;R25N;R50 NumberEU EINECS/ELINCS List EU Classification%Citric acid monohydrate5949-29-1 Not listedNot Listed*_____PZ00456 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 01-Apr-2010 Emergency telephone number:ChemSafe (24 hours).

3 +44 (0)208 762 8322 Contact MATERIAL SAFETY data SHEETPage 1 of 6 Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222 Pfizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 MATERIAL SAFETY data SHEET_____Sodium citrate, dihydrate6132-04-3 Not listedNot Listed*Water for Injection7732-18-5231-791-2 Not Listed*Propylparaben94-13-3202-307-7 Not Listed*Methylparaben99-76-3202-785-7 Not Listed*Additional Information:* ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for the full text of the R phrases mentioned in this Section, see Section 164. FIRST AID MEASURESEye Contact:Flush with water while holding eyelids open for at least 15 minutes.

4 Seek medical Contact:Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical :Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention :Remove to fresh air and keep patient at rest. Seek medical attention and Effects of Exposure:For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological FIRE FIGHTING MEASURESE xtinguishing Media:Water, dry powder or foam extinguishers are Combustion Products:Formation of toxic gases is possible during heating or Fighting Procedures:During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing / Explosion Hazards:Not applicable6.

5 ACCIDENTAL RELEASE MEASURESH ealth and SAFETY Precautions:Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8). Minimize for Cleaning / Collecting:Contain the source of spill if it is safe to do so. Collect spill with absorbent MATERIAL . Clean spillarea for EnvironmentalProtections:Place waste in an appropriately labeled, sealed container for disposal. Care should be taken toavoid environmental Consideration for LargeSpills:Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained : 2 of 6 Revision date: 01-Apr-2010 MATERIAL Name: Ondansetron Hydrochloride Solution forInjection MATERIAL SAFETY data SHEET_____7.

6 HANDLING AND STORAGEG eneral Handling:Avoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. When handling, useappropriate personal protective equipment (see Section 8). Releases to the environmentshould be avoided. Review and implement appropriate technical and procedural waste waterand waste disposal measures to prevent occupational exposure or environmental points of process emissions of this MATERIAL to the atmosphere should be controlledwith dust collectors, HEPA filtration systems or other equivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure purpose of the Occupational Exposure Band (OEB) classification system is to separate substances into different Hazard categorieswhen the available data are sufficient to do so, but inadequate to establish an Occupational Exposure Limit (OEL).

7 The OEB given isbased upon an analysis of all currently available data ; as such, this value may be subject to revision when new information Controls:Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this Exposure Controls:Refer to specific Member State legislation for requirements under Community Protective Equipment:Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).Hands:Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing :Wear SAFETY glasses or goggles if eye contact is :Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing protection:If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the PHYSICAL AND CHEMICAL - STABILITY AND REACTIVITYC hemical Stability:Stable under normal conditions of to Avoid:Not determinedIncompatible Materials.

8 As a precautionary measure, keep away from strong oxidizers_____PZ00456 Page 3 of 6 Ondansetron hydrochloride dihydratePhysical State:SolutionColor:ColorlessMolecular Formula:MixtureMolecular Weight:MixturePfizer Occupational ExposureBand (OEB):OEB3 (control exposure to the range of >10ug/m3 to < 100ug/m3)Revision date: 01-Apr-2010 MATERIAL Name: Ondansetron Hydrochloride Solution forInjectionVersion: MATERIAL SAFETY data SHEET_____11. TOXICOLOGICAL INFORMATIONG eneral Information:The information included in this section describes the potential hazards of the Toxicity: (Species, Route, End Point, Dose)Acute Toxicity Comments:A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the / Sensitization: (Study Type, Species, Severity)Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))Genetic Toxicity: (Study Type, Cell Type/Organism, Result)Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))Carcinogen Status.

9 None of the components of this formulation are listed as a carcinogen by IARC, NTP or : and Embryonic Development Rabbit Intravenous 4 mg/kg/day NOAEL No effects at maximum doseSkin Irritation Rabbit MildRat Para-periosteal LD50 20201 ug/kgOndansetron hydrochloride dihydratePage 4 of 6 Bacterial Mutagenicity (Ames) Salmonella , E. coli NegativeOndansetron hydrochloride dihydrateIn Vitro Chromosome Aberration Human Lymphocytes NegativeDog Oral LD50 > 45 mg/kgIn Vivo Chromosome Aberration Mouse Bone Marrow Negative7 Week(s) Rat Oral 160 mg/kg/day Maximally Tolerated DoseOndansetron hydrochloride dihydrate18 Month(s) Rat No route specified 1 mg/kg/day NOAEL Central Nervous System Liver2 Year(s) Rat Oral 10 mg/kg/day NOAEL Not carcinogenicOndansetron hydrochloride dihydrateRevision date.

10 01-Apr-20102 Year(s) Mouse Oral 30 mg/kg/day NOAEL Not carcinogenic12 Month(s) Dog No route specified 12 mg/kg/day NOAEL Central Nervous System LiverMaterial Name: Ondansetron Hydrochloride Solution forInjectionCitric acid monohydrateOndansetron hydrochloride dihydrateRat Oral LD50 95 mg/kgReproductive & Fertility Rat Oral 15 mg/kg/day NOAEL NegativeEye Irritation Rabbit MildFertility and Embryonic Development Rat Intravenous 4 mg/kg/day NOAEL No effects at maximum dose MATERIAL SAFETY data SHEET_____12. ECOLOGICAL INFORMATIONE nvironmental Overview:The environmental characteristics of this mixture have not been fully evaluated.