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HomeMy WebLinkAboutMerck GardasilProduct and Company Identification SAFETY DATA SHEET GARDASIL® 1. Page: 1/6 Revision 28-Dec-2009 PRODUCT NAME: GARDASIL®Label Name Chemical Name Not available Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant; HPV Vaccine. Synonyms MERCK & CO., INC. One Merck Drive Whitehouse Station, NJ 08889-0100 (908) 423-1000 (General Information Only) Emergency Telephone Number: 1-908-423-6000 (24/7/365) English Only Manufactured/Supplied by Intended Use Vaccine indicated for the prevention of cancer, precancerous or dysplastic lesions, genital warts, and infection caused by the Human Papillomavirus (HPV) types 6, 11, 16 and 18. Material Product Number 4045 - Carton of one 0.5 mL single-dose vial NDC 0006-4045-00 4045 - Carton of ten 0.5 mL single-dose vial NDC 0006-4045-41 4109 - Carton of six 0.5 mL single-dose prefilled syringe NDC 0006-4109-09 Composition/Information on Ingredients2. Component CAS Number Percent (%) HPV L1 VLPs Not available Not available Not available 0.024 Inactive ingredients Not available Not available Not available 99.976 Molecular weight EC Label Molecular Formula Not classified. Hazards Identification3. Appearance Label Text No immediate hazard with intact vials. Avoid direct contact with skin and eyes. Wash thoroughly after handling. Cloudy white liquid. CAUTION! VACCINE Potential Health Effects See Section 11 for detailed information. Emergency Overview *** Continued on next page *** GARDASIL®Product name Page: 2/6 Revision 28-Dec-2009 Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. Skin Contact In case of contact with eyes, rinse immediately with plenty of water.Get medical attention if symptoms occur. In case of contact, immediately flush skin with plenty of water. Remove contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. 4. If inhaled, remove to fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration. Get medical attention if symptoms occur. Notes to physician Treat supportively and symptomatically. For additional guidance refer to the current prescribing information or the local poison control center. Ingestion Inhalation Eye Contact First Aid Measures Fire Fighting Measures5. Hazardous Decomposition Products None known. In case of fire, use water spray (fog), foam, dry chemical, or CO 2.Extinguishing Media Not applicableFlammable Limits (% in air) Autoignition Temperature Not available No special procedures. Fire/Explosion Hazards None known. Combustibility Information Dust Explosivity Information Shock Sensitivity Not available Not applicable Not applicable Not availableOxidizing Properties Special Fire Procedures Flash Point Not applicable Personal Precautions 6. Accidental Release Measures See Section 8 for Personal Protective Equipment. Contact emergency personnel. Keep unnecessary personnel away. Methods for cleaning up Contain spilled material. For small spills add absorbent (soil may be used in the absence of other suitable materials) scoop up material and place in a sealed, liquid-proof container for disposal. For large spills dike spilled material or otherwise contain material to ensure runoff does not reach a waterway. Place spilled material in an appropriate container for disposal. Minimize contact of spilled material with soils to prevent runoff to surface waterways. See Section 13 for Waste Disposal Information. *** Continued on next page *** GARDASIL®Product name Page: 3/6 Revision 28-Dec-2009 Handling Handling and Storage Storage 7. Avoid contact with skin and eyes. Wash thoroughly after handling. Keep container tightly closed. Keep container in a cool, well-ventilated area. 8. Exposure Controls/Personal Protection Personal Protective Equipment None required when handling sealed vials. Adequate ventilation should be provided if there is risk of aerosol formation. Exposure Guidelines HPV L1 VLPs Not established Not established PB-ECL 2 Inactive ingredients Not available Not available Not available Eye/Face Protection None required when handling sealed vials. Safety glasses with side shields should be worn when handling bulk liquid formulation or filling vials. None required when handling sealed vials. Additional body garments should be used based upon the task being performed (e.g., sleevelets, apron, gauntlets, disposable suits). Skin Protection Respiratory Protection No respiratory protection required when handling bulk liquid formulation or sealed vials. As an adjunct to engineering controls, use an approved, properly fitted, powered air purifying respirator, or respirator of equivalent or greater protection if the potential exists for exposure to airborne aerosols. Work uniform or laboratory coat.Additional Protective Equipment Engineering Controls Component OSHA Permissible Exposure Limit (PEL) ACGIH Threshold Limit Value (TLV) Merck Exposure Control Limit (ECL) or PB-ECL Category PB-ECL category is an internal Merck control band. Refer to control recommendations below. Not available Physical and Chemical Properties Melting Point Boiling Point Not available pH Flash point Not applicable 9. Not available Not availableOdor/Threshold Limit Appearance Cloudy white liquid. *** Continued on next page *** GARDASIL®Product name Page: 4/6 Revision 28-Dec-2009 Vapor Pressure Vapor Density Solubility Not available Not available Not available Not available Not applicableFlammable Limits (% in air) Not availablePartition Coefficient Autoignition Temperature Specific Gravity Not available Volatility Component Not available Hazardous Decomposition Products Conditions to Avoid Not available Stability and Reactivity None known. Not availableStability 10. Not available Hazardous Polymerization Not available Incompatibility Toxicological Information11. Effects of Acute Exposure Inhalation Not available Not availableIngestion Skin contact Formulation may be irritating. Formulation may be irritating.Eye contact Toxicity Data Component Test Species Route Result HPV L1 VLPs Tolerability Mouse IM No adverse effects except local irritation Inactive Ingredients Not available Not available Not available Not available GARDASIL is a vaccine indicated for the prevention of cancer, precancerous or dysplastic lesions, genital warts, and infection caused by the Human Papillomavirus (HPV) types targeted by the vaccine. GARDASIL contains L1 VLPs, which are proteins that resemble wild-type virions. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce. The most commonly reported side effects include pain, swelling, itching and redness at the injection site, fever, nausea, dizziness, and vomiting. Syncope (fainting) with convulsions has also been reported. GARDASIL is contraindicated in individuals hypersensitive to any components of the vaccine. GARDASIL is not recommended for pregnant women. It is not given chronically, but when injected 3 times in laboratory animals in a 13-week repeated dose intramuscular toxicity study, the primary effects were local irritation at the injection site and enlargement of the draining lymph nodes. There was also an antibody response as expected. Animal studies do not indicate Effects of Chronic Exposure Routes of Entry Ingestion: Inhalation: Skin Contact: No. Yes No. *** Continued on next page *** GARDASIL®Product name Page: 5/6 Revision 28-Dec-2009 Medical Conditions Aggravated by Overexposure: Not available direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development. GARDASIL induced a specific antibody response against HPV Types 6, 11, 16, and 18 in pregnant rats following one or multiple intramuscular injections. Antibodies against all 4 H PV types were transferred to the offspring during gestation and possibly during lactation. Not listed as a carcinogen by OSHA, NTP or IARC.Carcinogen Designation Ecological Information12. Ecotoxicity Data Component Species Period Result HPV L1 VLPs Not available Not available Not available Inactive ingredients Not available Not available Not available Environmental Fate Not available Environmental Effects Not available Disposal Considerations13. Avoid contact of spilled material and runoff with soil and surface waterways. Dispose of or treat all spill residues including contaminated soils following all applicable regulations. Waste Disposal Information 14. Transport Information Not regulated.U.S. DOT IATA/ICAO Not regulated. IMO Not regulated. ADR/RID Not regulated. Shipping Description Regulatory Information15. U.S. Federal Regulations International Regulations Not classified as Dangerous according to the Dangerous Substances Directive (DSD). Hazardous per OSHA Hazard Communication Standard criteria (29 CFR 1910.1200). State Regulations Not available *** Continued on next page *** GARDASIL®Product name Page: 6/6 Revision 28-Dec-2009 Other Information16. Revisions: Effects of Chronic Exposure Revision: Date of Preparation 12/28/2009. 26-Jun-2007 26-Jun-2007 Validation Date Date of Previous Issue 12/28/2009. 1-908-423-7903 Merck & Co., Inc. One Merck Drive Whitehouse Station, NJ 08889-0100 MSDS Coordinator: Disclaimer: While this information and recommendations set forth are believed to be accurate as of the date hereof, MERCK & CO, INC. makes no warranty with respect hereto and disclaims all liability from reliance thereon.