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Home My WebLink AboutPfizer Prevnar 13 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKING Product Identifier Material Name: Prevnar 13 Trade Name:Prevnar 13; PREVENAR; PREVENAR 13 Synonyms:Pneumococcal 13-Valent Conjugate Vaccine Chemical Family:Not determined Relevant Identified Uses of the Substance or Mixture and Uses Advised Against Intended Use:Pharmaceutical product Details of the Supplier of the Safety Data Sheet 2. HAZARDS IDENTIFICATION Classification of the Substance or Mixture GHS - Classification Not classified as hazardous EU Classification: EU Indication of danger: Not classified Label Elements Other Hazards Australian Hazard Classification (NOHSC): Non-Hazardous Substance. Non-Dangerous Goods. Note:This document has been prepared in accordance with standards for workplace safety, which requires the inclusion of all known hazards of the product or its ingredients regardless of the potential risk. The precautionary statements and warning included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace. Additional Information:Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008. This substance is not classified as dangerous according to Directive 67/548/EEC. _______________________________________________________________________________________________________ PZ01454 Version: 3.1 Emergency telephone number: CHEMTREC (24 hours): 1-800-424-9300 SAFETY DATA SHEET Emergency telephone number: International CHEMTREC (24 hours): +1-703-527-3887 Page 1 of 7 Contact E-Mail:pfizer-MSDS@pfizer.com Revision date: 31-Oct-2014 Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-800-879-3477 Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom +00 44 (0)1304 616161 SAFETY DATA SHEET _______________________________________________________________________________________________________ 3. COMPOSITION / INFORMATION ON INGREDIENTS Ingredient CAS Number EU EINECS/ELINCS List EU Classification GHS Classification % Pneumococcal 13-valent Conjugate Not Assigned Not Listed Not Listed Not Listed * Aluminum phosphate 7784-30-7 232-056-9 Not Listed Not Listed * Polysorbate 80 9005-65-6 Not Listed Not Listed Not Listed * Saline suspension MIXTURE Not Listed Not Listed Not Listed * Succinate buffer Not assigned Not Listed Not Listed Not Listed * Additional Information:* Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety. In accordance with 29 CFR 1910.1200, the exact percentage composition of this mixture has been withheld as a trade secret. 4. FIRST AID MEASURES Description of First Aid Measures Eye Contact:Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately. Skin Contact:Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention. Ingestion:Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately. Inhalation:Remove to fresh air and keep patient at rest. Seek medical attention immediately. Most Important Symptoms and Effects, Both Acute and Delayed Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - Hazards Identification and/or Section 11 - Toxicological Information. Medical Conditions Aggravated by Exposure: None known Indication of the Immediate Medical Attention and Special Treatment Needed Notes to Physician:None 5. FIRE FIGHTING MEASURES Extinguishing Media:Extinguish fires with CO2, extinguishing powder, foam, or water. Special Hazards Arising from the Substance or Mixture Hazardous Combustion Products: Formation of toxic gases is possible during heating or fire. Fire / Explosion Hazards:Fine particles (such as mists) may fuel fires/explosions. Advice for Fire-Fighters During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus. _______________________________________________________________________________________________________ PZ01454 Material Name: Prevnar 13 Version: 3.1 Page 2 of 7 Revision date: 31-Oct-2014 SAFETY DATA SHEET _______________________________________________________________________________________________________ 6. ACCIDENTAL RELEASE MEASURES Personal Precautions, Protective Equipment and Emergency Procedures Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. Environmental Precautions Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release. Methods and Material for Containment and Cleaning Up Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill area thoroughly. Additional Consideration for Large Spills: Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel. 7. HANDLING AND STORAGE Precautions for Safe Handling Avoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash thoroughly after handling. Releases to the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent controls. Conditions for Safe Storage, Including any Incompatibilities Storage Conditions:Store in a refrigerator. Storage Temperature:2 - 8 °C (35 to 45°F) Specific end use(s):Vaccine 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Control Parameters Refer to available public information for specific member state Occupational Exposure Limits. Exposure Controls Engineering Controls:Engineering controls should be used as the primary means to control exposures. General room ventilation is adequate unless the process generates dust, mist or fumes. Personal Protective Equipment: Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE). Hands:Impervious gloves are recommended if skin contact with drug product is possible and for bulk processing operations. Eyes:Wear safety glasses or goggles if eye contact is possible. Skin:Impervious protective clothing is recommended if skin contact with drug product is possible and for bulk processing operations. Respiratory protection:If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL. _______________________________________________________________________________________________________ PZ01454 Material Name: Prevnar 13 Aluminum phosphate Version: 3.1 Page 3 of 7 ACGIH Threshold Limit Value (TWA)1 mg/m3 Russia OEL - TWA 6 mg/m3 Revision date: 31-Oct-2014 SAFETY DATA SHEET _______________________________________________________________________________________________________ 9. PHYSICAL AND CHEMICAL PROPERTIES Solvent Solubility:No data available Water Solubility:No data available pH:No data available. Melting/Freezing Point (°C):No data available Boiling Point (°C):No data available. Partition Coefficient: (Method, pH, Endpoint, Value) Decomposition Temperature (°C):No data available. Evaporation Rate (Gram/s):No data available Vapor Pressure (kPa):No data available Vapor Density (g/ml):No data available Relative Density:No data available Viscosity:No data available Flammablity: Autoignition Temperature (Solid) (°C):No data available Flammability (Solids):No data available Flash Point (Liquid) (°C):No data available Upper Explosive Limits (Liquid) (% by Vol.):No data available Lower Explosive Limits (Liquid) (% by Vol.):No data available 10. STABILITY AND REACTIVITY Reactivity:No data available Chemical Stability:Stable under normal conditions of use. Possibility of Hazardous Reactions Oxidizing Properties:No data available Conditions to Avoid:Fine particles (such as mists) may fuel fires/explosions. As a precautionary measure, keep away from heat sources and electrostatic discharge. Incompatible Materials:As a precautionary measure, keep away from strong oxidizers Hazardous Decomposition Products: No data available 11. TOXICOLOGICAL INFORMATION Information on Toxicological Effects General Information:The information included in this section describes the potential hazards of the individual ingredients. _______________________________________________________________________________________________________ PZ01454 Version: 3.1 No data available Odor Threshold:No data available. Page 4 of 7 Molecular Formula:Mixture Saline suspension No data available Molecular Weight:Mixture Pneumococcal 13-valent Conjugate No data available Physical State:Homogenous Suspension Aluminum phosphate Revision date: 31-Oct-2014 No data available Color:White Succinate buffer Material Name: Prevnar 13 No data available Odor:No data available. Polysorbate 80 SAFETY DATA SHEET _______________________________________________________________________________________________________ 11. TOXICOLOGICAL INFORMATION Short Term:In the event of accidental injection, an allergic reaction may occur. If an allergic reaction occurs, the worker should be removed to the nearest emergency room and the appropriate therapy instituted. Known Clinical Effects:Based on clinical trials in humans, possible adverse effects following exposure to this compound may include: swelling, tenderness, and redness at the injection site, fever, lack of appetite, irritability, sleepiness (somnolence), sleeplessness, allergic reaction, and anaphylactic reactions. Acute Toxicity: (Species, Route, End Point, Dose) Acute Toxicity Comments:A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievable at the highest dose used in the test. Repeated 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 Weeks. Reproduction & Development Toxicity: (Duration, 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 OSHA. 12. ECOLOGICAL INFORMATION Environmental Overview:Environmental properties have not been investigated. Releases to the environment should be avoided. Toxicity:No data available Persistence and Degradability:No data available Bio-accumulative Potential:No data available Mobility in Soil:No data available _______________________________________________________________________________________________________ PZ01454 Pneumococcal 13-valent Conjugate Aluminum phosphate 8 Week(s) Rat Subcutaneous * 0.5 mL NOAEL None identified 13 Week(s) Rat Subcutaneous * 0.5 mL NOAEL None identified Mouse Oral LD 50 > 5000 mg/kg 13 Week(s) Monkey Subcutaneous * 0.5 mL NOAEL None identified Pneumococcal 13-valent Conjugate Rabbit Dermal LD 50 > 4640mg/kg Revision date: 31-Oct-2014 Polysorbate 80 Rat Subcutaneous Maximum Non-Lethal Dose .5 mL Pneumococcal 13-valent Conjugate Rat Oral LD50 25 g/kg Fertility and Embryonic Development Rabbit Intramuscular20 times human dose NOAEL No effects at maximum dose, Not teratogenic Material Name: Prevnar 13 Non-human Primate Subcutaneous Maximum Non-Lethal Dose .5mL Version: 3.1 Page 5 of 7 SAFETY DATA SHEET _______________________________________________________________________________________________________ 13. DISPOSAL CONSIDERATIONS Waste Treatment Methods:Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater. 14. TRANSPORT INFORMATION The following refers to all modes of transportation unless specified below. Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations. 15. REGULATORY INFORMATION Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture Additonal Information:This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. Canada - WHMIS: Classifications WHMIS hazard class: None required Ingredients: _______________________________________________________________________________________________________ PZ01454 CERCLA/SARA 313 Emission reporting Not Listed Revision date: 31-Oct-2014 California Proposition 65 Not Listed CERCLA/SARA 313 Emission reporting Inventory - United States TSCA - Sect. 8(b)Present Not Listed Material Name: Prevnar 13 Australia (AICS):Present EU EINECS/ELINCS List 232-056-9 California Proposition 65 Not Listed Polysorbate 80 Version: 3.1 CERCLA/SARA 313 Emission reporting Not Listed Page 6 of 7 California Proposition 65 Not Listed EU EINECS/ELINCS List Not Listed Aluminum phosphate Pneumococcal 13-valent Conjugate SAFETY DATA SHEET _______________________________________________________________________________________________________ 15. REGULATORY INFORMATION 16. OTHER INFORMATION Data Sources:Pfizer proprietary drug development information. Publicly available toxicity information. Reasons for Revision:Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking. Revision date:31-Oct-2014 Prepared by: Product Stewardship Hazard Communication Pfizer Global Environment, Health, and Safety Operations Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known information at this time. End of Safety Data Sheet _______________________________________________________________________________________________________ PZ01454 Not Listed EU EINECS/ELINCS List Not Listed EU EINECS/ELINCS List Not Listed Material Name: Prevnar 13 Saline suspension Version: 3.1 Page 7 of 7 CERCLA/SARA 313 Emission reporting Not Listed Inventory - United States TSCA - Sect. 8(b) California Proposition 65 Not Listed Present EU EINECS/ELINCS List Not Listed Succinate buffer Australia (AICS):Present CERCLA/SARA 313 Emission reporting Not Listed Revision date: 31-Oct-2014 California Proposition 65