MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Azithromycin TabletsTrade Name:ZithromaxChemical Family:MixtureIntended Use:Pharmaceutical product used as antibiotic agent2. HAZARDS IDENTIFICATIONA ppearance:White to off-white film-coated tabletsStatement of Hazard:Non-hazardous in accordance with international standards for workplace Term:Dust may cause irritation if tablets are crushed or broken . Individuals sensitive to thischemical or other materials in its chemical class may develop allergic Clinical Effects:May cause effects similar to those seen in clinical use including transient diarrhea, nausea andabdominal 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 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 COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS ListClassification%Azithromycin dihydrate117772-70-0 Not listedNot Listed56 Starch, pregelatinized9005-25-8232-679-6 Not Listed*Sodium lauryl sulfate151-21-3205-788-1 Not Listed*Magnesium stearate557-04-0209-150-3 Not Listed*IngredientCAS NumberEU EINECS/ELINCS ListClassification%Calcium phosphate dibasic, anhydrous7757-93-9231-826-1 Not MATERIAL SAFETY data SHEETPage 1 of 7 Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York.

3 New York 100171-212-573-2222 Pfizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 08-Sep-2009 Emergency telephone number:ChemSafe (24 hours): +44 (0)208 762 8322 Contact E-Mail: MATERIAL SAFETY data SHEET_____Croscarmellose sodium74811-65-7 Not listedNot Listed*Additional Information:* ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for FIRST AID MEASURESEye Contact:Flush with water while holding eyelids open for at least 15 minutes. 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.

4 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 carbon dioxide, dry chemical, or water Combustion Products:Emits toxic fumes of carbon monoxide, carbon dioxide, and nitrogen Fighting Procedures:Wear approved positive pressure, self-contained breathing apparatus and full protective turnout gear. Use caution in approaching / Explosion Hazards:Not determined6. ACCIDENTAL RELEASE MEASURESH ealth and SAFETY Precautions:Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8).

5 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 : 2 of 7 Revision date: 08-Sep-2009 MATERIAL Name: Azithromycin Tablets MATERIAL SAFETY data SHEET_____7. 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 hands and any exposed skinafter removal of PPE. Releases to the environment should be avoided. Review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure or environmental releases. Potential points of process emissions of thismaterial to the atmosphere should be controlled with dust collectors, HEPA filtration systems orother equivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure Method:Analytical method available for Azithromycin.

7 Contact Pfizer Inc for further 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 mg/m3 TWAS pain OEL - TWAL istedCalcium phosphate dibasic, anhydrousVersion: OEL - TWAL istedAustralia TWA10 mg/m3 Sodium lauryl sulfateAzithromycin dihydratePfizer OEL TWA-8 mg/m Belgium OEL - TWAM agnesium stearateListedACGIH Threshold Limit Value (TWA)10 mg/m3 TWAPage 3 of 7 Australia TWA10 mg/m3 Bulgaria OEL - TWAL istedBelgium OEL - TWAL istedIreland OEL - TWAsListedPfizer OEL TWA-8 Hr.

8 Lithuania OEL - TWAL istedCzech Republic OEL - TWAL istedPortugal OEL - TWAL isted500 g/m3 Spain OEL - TWAL istedGreece OEL - TWAS weden OEL - TWAsListedListedIreland OEL - TWAsListedStarch, pregelatinizedRevision date: 08-Sep-2009 OSHA - Final PELS - TWAs:15 mg/m3 total5 mg/m3 MATERIAL Name: Azithromycin TabletsPortugal OEL - TWAL istedACGIH Threshold Limit Value (TWA) MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONP ersonal 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 PROPERTIESP olymerization:Will not occur10.

9 STABILITY AND REACTIVITYS tability:Stable under normal conditions of to Avoid:Fine particles (such as dust and mists) may fuel 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)_____165 Rat Oral LD50 1288 mg/kgColor:White to off-whiteAzithromycin dihydrateMouse (F) Oral LD50 4000 mg/kgMolecular Formula:MixtureMouse (M) Oral LD50 3000 mg/kgRevision date: 08-Sep-2009 Rat Oral LD50 > 2000 mg/kgMolecular Weight:MixtureMagnesium stearateMaterial Name.

10 Azithromycin TabletsSodium lauryl sulfateRat Oral LD50 > 2000 mg/kgEye Irritation Rabbit SevereVersion: 4 of 7 Rat Inhalation LC50 > 2000 mg/m3 Physical State:Film-coated tabletsSodium lauryl sulfate MATERIAL SAFETY data SHEET_____11. TOXICOLOGICAL INFORMATIONR epeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))Genetic Toxicity: (Study Type, Cell Type/Organism, Result)Carcinogen Status:None of the components of this formulation are listed as a carcinogen by IARC, NTP or ECOLOGICAL INFORMATIONE nvironmental Overview:In the environment, the active ingredient in this formulation is expected to mainly reside in theaquatic environment and slowly , Persistence andDegradability:Azithromycin half life < 28 days (Aerobic Biodegredation - Water)Bioaccumulation and Toxicity.