MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Amoxicillin TabletsTrade Name:ZIMOXC hemical Family:MixtureIntended Use:Pharmaceutical product used as antibiotic agent2. HAZARDS IDENTIFICATIONA ppearance:TabletSignal Word:WARNINGS tatement of Hazard:May cause allergic or asthmatic symptoms or breathing difficulties if Term:Individuals who are allergic to penicillin antibiotics could have allergic reaction, possibly an allergic reaction occurs, the worker should be removed to the nearest emergency roomand the appropriate therapy Clinical Effects:Individuals who are sensitive to beta lactam antibiotics, both penicillins and cephalosporins,may experience contact or systemic hypersensitivity and anaphylaxis upon exposure to thisdrug.

2 May cause effects similar to those generally seen in clinical use of antibiotics includinggastrointestinal irritation, vomiting, transient diarrhea, nausea, and abdominal Indication of danger:HarmfulEU Hazard Symbols:EU Risk Phrases:R42/43 - May cause sensitization by inhalation and skin Hazard Classification(NOHSC):Hazardous Substance. Non-Dangerous :This document has been prepared in accordance with standards for workplace SAFETY , whichrequire the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warnings included may not apply in all needs may vary depending upon the potential for exposure in your LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 09-Feb-2009 Emergency telephone number:CHEMTREC (24 hours): 1-800-262-8200 Contact MATERIAL SAFETY data SHEETPage 1 of 8 Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222 MATERIAL SAFETY data SHEET_____3.

3 COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS ListClassification%Amoxicillin trihydrate61336-70-7 Not listedXn;R42 silicon dioxide7631-86-9231-545-4 EEC No. 418-260-2 Not Listed*Magnesium stearate557-04-0209-150-3 Not Listed*Microcrystalline cellulose9004-34-6232-674-9 Not Listed*IngredientCAS NumberEU EINECS/ELINCS ListClassification%Sodium starch glycolate9063-38-1 Not listedNot 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 attention. For information on potential delayed effects, see Section 2 - HazardsIdentification and/or Section 11 - Toxicological :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:Use water, carbon dioxide, foam or dry chemical 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 applicable_____PZ00945 MATERIAL Name: Amoxicillin TabletsVersion: 2 of 8 Revision date: 09-Feb-2009 MATERIAL SAFETY data SHEET_____6.

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 spilled MATERIAL by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area 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 HANDLING AND STORAGEG eneral Handling:Minimize dust generation and accumulation.

6 If tablets or capsules are crushed and/or broken,avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, useappropriate personal protective equipment (see Section 8). Wash thoroughly after to the environment should be avoided. Review and implement appropriate technicaland procedural waste water and waste disposal measures to prevent occupational exposure orenvironmental releases. Potential points of process emissions of this MATERIAL to theatmosphere should be controlled with dust collectors, HEPA filtration systems or otherequivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure mg/m3 TWA= 6 mg/m3 TWA= 2 mg/m3 TWAR evision date: 09-Feb-2009 Latvia OEL - TWAL istedMaterial Name: Amoxicillin TabletsOSHA - Final PELs - Table Z-3 Mineral D:(80)/(% SiO2) mg/m3 TWA= 20 mppcf TWAA ustria OEL - MAKsListedSlovenia OEL - TWAL istedMagnesium stearateVersion.

7 Threshold Limit Value (TWA)= 10 mg/m3 TWA except stearates of toxic metalsCzech Republic OEL - TWAL istedAustralia TWA= 10 mg/m3 TWAPage 3 of 8 Belgium OEL - TWAL istedEstonia OEL - TWAI reland OEL - TWAs= 10 mg/m3 TWA except lead stearateListedLithuania OEL - TWAL istedColloidal silicon dioxidePortugal OEL - TWAL istedGermany - TRGS 900 - TWAs= 4 mg/m3 TWAS pain OEL - TWAL istedSweden OEL - TWAs= 5 mg/m3 LLVG ermany (DFG) - MAK= 4 mg/m3 MAKA ustralia TWAI reland OEL - TWAs MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONThe 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).

8 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:General room ventilation is adequate unless the process generates dust, mist or controls should be used as the primary means to control exposures. Keepairborne contamination 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 PROPERTIES:10.

9 STABILITY AND REACTIVITYS tability:Stable under normal conditions of to Avoid:Fine particles (such as dust and mists) may fuel OEL - TWAs= 10 mg/m3 TWA= 4 mg/m3 TWAACGIH Threshold Limit Value (TWA)Latvia OEL - TWAL isted= 10 mg/m3 TWAOSHA - Final PELS - TWAs:= 15 mg/m3 TWA total= 5 mg/m3 TWAR evision date: 09-Feb-2009 Portugal OEL - TWAL istedAustralia TWA= 10 mg/m3 TWAR omania OEL - TWAP hysical State:TabletListedColor:No data Name: Amoxicillin TabletsMolecular Formula:MixtureMolecular Weight:MixtureSpain OEL - TWAL istedBelgium OEL - TWAL istedAmoxicillin trihydrateVersion: 4 of 8 Pfizer Occupational ExposureBand (OEB):OEB 2 - Sensitizer (control exposure to the range of >100ug/m3 to < 1000ug/m3, provideadditional precautions to protect from skin contact)Estonia OEL - TWAL istedMicrocrystalline celluloseFrance OEL - TWAL isted MATERIAL SAFETY data SHEET_____10.

10 STABILITY AND REACTIVITYI ncompatible Materials:As a precautionary measure, keep away from strong oxidizers11. 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)Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))Carcinogen Status:None of the components of this formulation are listed as a carcinogen by IARC, NTP or ECOLOGICAL INFORMATIONE nvironmental Overview:The environmental characteristics of this MATERIAL have not been fully evaluated.