MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: prevnar 13 Trade Name: prevnar 13 Synonyms:Pneumococcal 13-Valent Conjugate VaccineChemical Family:Not determinedIntended Use:Pharmaceutical product2. HAZARDS IDENTIFICATIONA ppearance:White homogenous suspensionStatement of Hazard:Non-hazardous in accordance with international standards for workplace Hazard Information:Short Term:In the event of accidental injection, an allergic reaction may occur. If an allergic reactionoccurs, the worker should be removed to the nearest emergency room and the appropriatetherapy Clinical Effects:Based on clinical trials in humans, possible adverse effects following exposure to thiscompound may include: swelling, tenderness, and redness at the injection site, fever, lack ofappetite, irritability, sleepiness (somnolence), sleeplessness, allergic reaction, and Hazard Classification(NOHSC):Non-Hazardous Substance.

2 Non-Dangerous Information:Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008. Thissubstance is not classified as dangerous according to Directive 67/548 :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 INGREDIENTSI ngredientCAS NumberEU EINECS/ELINCS List EU Classification%Pneumococcal 13-valent ConjugateNot AssignedNot ListedNot MATERIAL SAFETY data SHEETPage 1 of 5 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 Emergency telephone number:CHEMTREC (24 hours).

3 1-800-424-9300 Revision date: 16-Nov-2012 Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887 Contact E-Mail: MATERIAL SAFETY data SHEET_____3. COMPOSITION/INFORMATION ON INGREDIENTSA luminum phosphate7784-30-7232-056-9 Not Listed*Polysorbate 809005-65-6 Not ListedNot Listed*Saline suspensionMIXTURENot ListedNot Listed*Succinate bufferNot assignedNot 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.

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:Use carbon dioxide, dry chemical, or water 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.

5 Fine particles (such as mists) may fuel 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.

6 Report emergencysituations immediately. Clean up operations should only be undertaken by trained 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).Storage Conditions:Store in a date: 16-Nov-2012 MATERIAL Name: prevnar 13 Version: 2 of 5 MATERIAL SAFETY data SHEET_____7. HANDLING AND STORAGES torage Temperature:2 - 8 C (35 to 45 F)8. EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure Controls:Engineering controls should be used as the primary means to control exposures.

7 Generalroom ventilation is adequate unless the process generates dust, mist or 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 PROPERTIES10.

8 STABILITY AND REACTIVITYC hemical Stability:Stable under normal conditions of to Avoid:Fine particles (such as mists) may fuel fires/explosions. As a precautionary measure, keepaway from heat sources and electrostatic 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 :Acute Toxicity: (Species, Route, End Point, Dose)_____PZ014541 mg/m3 MATERIAL Name: prevnar 13 Version: 3 of 5 Aluminum phosphatePhysical State:Homogenous SuspensionPneumococcal 13-valent ConjugateColor:Rat Subcutaneous Maximum Non-Lethal Dose.

9 5 mLWhiteNon-human Primate Subcutaneous Maximum Non-Lethal Dose .5 mLRevision date: 16-Nov-2012 Molecular Formula:MixtureMolecular Weight:MixtureACGIH Threshold Limit Value (TWA) MATERIAL SAFETY data SHEET_____11. TOXICOLOGICAL INFORMATIONA cute Toxicity Comments:A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)Repeated Dose Toxicity Comments: Pneumococcal 13-valent Conjugate: * Notes: Doses are administrated 1 Dose/2 & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))Carcinogen Status.

10 None of the components of this formulation are listed as a carcinogen by IARC, NTP or ECOLOGICAL INFORMATIONE nvironmental Overview:Environmental properties have not been investigated. Releases to the environment should DISPOSAL CONSIDERATIONSW aste Treatment Methods:Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the MATERIAL , review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release.