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Home My WebLink AboutMerck PedvaxHIBProduct and Company Identification SAFETY DATA SHEET Liquid PedvaxHIB™ 1. Page: 1/6 Revision 8-Oct-2007 PRODUCT NAME: Liquid PedvaxHIB™Label Name Chemical Name Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Not availableSynonyms MERCK & CO., INC. One Merck Drive Whitehouse Station, NJ 08889-0100 (908) 423-1000 Emergency Telephone Number: 1-732-594-5555 Manufactured/Supplied by Intended Use Vaccine indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age. Material Product Number No. 4897 — A box of 10 single-dose vials of liquid vaccine NDC 0006-4897-00 Composition/Information on Ingredients2. Component CAS Number Percent (%) Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Not available Not available Not available <0.1 Aluminum hydroxyphosphate sulfate Not available Not available 20257-20-9 <0.1 Inactive Ingredients - - - Not available - - - >99.9 Molecular weight EC Label Molecular Formula Not classified. Hazards Identification3. Appearance Label Text Avoid direct contact with skin and eyes. Wash thoroughly after handling. No immediate hazard from intact vials. Slightly opaque white liquid CAUTION! VACCINE Potential Health Effects See Section 11 for detailed information. Emergency Overview *** Continued on next page *** Liquid PedvaxHIB™Product name Page: 2/6 Revision 8-Oct-2007 Do NOT induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms appear. Skin Contact In case of contact, flush eyes with plenty of water. Get medical attention if symptoms occur. Wash with soap and water.Get medical attention if irritation develops. 4. If inhaled, remove to fresh air. Get medical attention if symptoms appear. 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 CO2.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. Follow all fire fighting procedures (Section 5). 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. For additional assistance in the U.S., CHEMTREC provides a toll-free Hotline for chemical emergencies regarding spills, leaks, exposure or accidents: 1-800-424-9300. For emergency calls from outside the U.S.: 1-703-527-3887 *** Continued on next page *** Liquid PedvaxHIB™Product name Page: 3/6 Revision 8-Oct-2007 Handling Handling and Storage Storage 7. Avoid direct contact with skin and eyes. Wash thoroughly after handling. In the absence of specific storage recommendations, keep container in a cool, well-ventilated area. Keep container tightly closed. 8. Exposure Controls/Personal Protection Personal Protective Equipment Adequate ventilation should be provided if there is risk of aerosol formation. None required when handling sealed vials. Exposure Guidelines Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Not established Not established PB-ECL 3* Aluminum hydroxyphosphate sulfate Not available Not available Not available Inactive Ingredients Not available Not available Not available Eye/Face Protection 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) to avoid exposed skin surfaces. None required when handling sealed vials. 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 *Corresponds to 10-100 ug/m3 as an 8-hr TWA. PB-ECL category is an internal Merck control band. 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 Slightly opaque white liquid *** Continued on next page *** Liquid PedvaxHIB™Product name Page: 4/6 Revision 8-Oct-2007 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 Not available Not availableEye contact Toxicity Data Component Test Species Route Result Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Not available Not available Not available Not available Aluminum hydroxyphosphate sulfate Not available Not available Not available Not available This compound is a vaccine indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age. PedvaxHIB showed no adverse effects in general safety testing conducted in guinea pigs and mice. Because the lipopolysaccharide (LPS) contained by OMPC has the capacity to elicit a pryogenic response when the LPS is biologically accessible, pyrogenicity tests through intramuscular and intravenous routes were developed and are conducted in rabbits. Release criteria require that no significant temperature rise is observed in these tests. PedvaxHIB has not been evaluated for its carcinogenic, mutagenic potential, or the potential to impair fertility. The most frequently reported (>1%) adverse reactions, without regard to causality, were fever (>101°F), irritability, sleepiness, Effects of Chronic Exposure Routes of Entry Ingestion: Inhalation: Skin Contact: No. Yes No. *** Continued on next page *** Liquid PedvaxHIB™Product name Page: 5/6 Revision 8-Oct-2007 Medical Conditions Aggravated by Overexposure: Not available injection-site pain/soreness, injection-site erythema (<2.5 cm diameter), injection-site swelling/induration (<2.5 cm diameter), unusual high-pitched crying, prolonged crying (>4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection. Not listed as a carcinogen by OSHA, NTP or IARC.Carcinogen Designation Ecological Information12. Ecotoxicity Data Component Species Period Result Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Not available Not available Not available Aluminum hydroxyphosphate sulfate 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). Not hazardous per OSHA Hazard Communication Standard criteria (29 CFR 1910.1200) State Regulations Not available *** Continued on next page *** Liquid PedvaxHIB™Product name Page: 6/6 Revision 8-Oct-2007 Other Information16. Revision:10/8/2007. 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. MSDS Coordinator:1-908-423-7903 Merck & Co., Inc. Two Merck Drive P.O. Box 200, WS2W-13 Whitehouse Station, NJ 08889-0200 U.S.A.