SAFETY DATA SHEET 1. Identification Product identifier TWINRIX ADULT Other means of identification Synonyms TWINRIX ADULT INJECTION 720 EL U AND 20 MCG/ML * TWINRIX SUSPENSION FOR INJECTION * TWINRIX ADULT PRE-FILLED SYRINGE * TWINRIX ERWACHSENE AMPULLE MIT 1 ML SUSPENSION * TWINRIX ERWACHSENE FERTIGSPRITZE MIT 1 ML SUSPENSION * HAB ADULT (720/20) * COMBINED HEPATITIS A/HEPATITIS B VACCINE * TWINRIX VACUNA COMBINADA ANTIHEPATITIS A Y B * TWINRIX VACUNA CONTRA LA HEPATITIS A Y B * TWINRIX ADULTO * AMBIRIX * HEPATITIS A VIRUS ANTIGEN (HM175) AND r-DNA HEPATITIS B SURFACE ANTIGEN (HBsAg) COMBINED VACCINE Recommended use Medicinal Product This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace. It is not intended to provide information relevant to medicinal use of the product. In this instance patients should consult prescribing information/package insert/product label or consult their pharmacist or physician. For health and safety information for individual ingredients used during manufacturing, refer to the appropriate safety data sheet for each ingredient. Recommended restrictions No other uses are advised. Manufacturer/Importer/Supplier/Distributor information COMPANY NAME GlaxoSmithKline US Address: 5 Moore Drive Research Triangle Park, NC 27709 USA Telephone: +1-888-825-5249 (General Inquiries) Email: [email protected] Website: www.gsk.com EMERGENCY CONTACTS CHEMTREC EMERGENCY NUMBERS Telephone: +(1) 703 527 3887 (International) 24/7; multi-language response Contract Number: CCN9484 VERISK 3E GLOBAL INCIDENT RESPONSE Telephone: +(1) 760 476 3971 (In country) +(1) 760 476 3962 or +(1) 866 519 4752 (International) 24/7; multi-language response Contract Number: 334878 2. Hazard(s) identification Classified hazards Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device. Label elements Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device. Hazard(s) not otherwise classified (HNOC) Exempt from requirements - product regulated as a medicinal product, cosmetic product or medical device. 3. Composition/information on ingredients Mixtures Material name: TWINRIX ADULT SDS US 1276 Version #: 20 Revision date: 05-29-2018 Issue date: 05-29-2018 1 / 9 Chemical name Common name and synonyms CAS number % SODIUM CHLORIDE COMMON SALT 7647-14-5 90 ROCK SALT SODIUM MONOCHLORIDE SALT SEA SALT TABLE SALT SALT, WHITE CRYSTALS, SOLAR ALUMINUM PHOSPHATE ALUMINUM PHOSPHATE 7784-30-7 4 ALUMINIUM PHOSPHATE TRIBASIC ALUMINIUM ORTHOPHOSPHATE ALUMINIUM HYDROXIDE ALUMIGEL 21645-51-2 0.5 ALUMINA HYDRATED ALUMINA TRIHYDRATE ALPHA-ALUMINA TRIHYDRATE ALUMINIC ACID ALUMINIUM HYDROXIDE ALUMINUM HYDRATE ALUMINUM(III) HYDROXIDE ALUMINUM HYDROXIDE GEL ALUMINUM OXIDE TRIHYDRATE ALUMINUM TRIHYDRATE ALUMINUM TRIHYDROXIDE FORMALDEHYDE 35% SOLUTION FORMALIN 50-00-0 < 0.1 FORMIC ALDEHYDE FORMALIN, (METHANOL-FREE) METHANAL METHYL ALDEHYDE METHYLENE GLYCOL METHYLENE OXIDE TETRAOXYMETHYLENE OXOMETHANE OXYMETHYLENE METHALDEHYDE NEOMYCIN SULFATE NEOMYCIN, SULFATE (SALT) 1405-10-3 < 0.1 NEOMYCIN SULPHATE MYCERIN SULPHATE 242 (GW ACN) MYCIGUENT NEOMIX NEOMYCIN SULFATE USP POWDER 50/50 HEPATITIS A VIRUS ANTIGEN HEPATITIS A VIRUS INACTIVATED Unassigned Not Applicable (HM175 STRAIN) r-DNA HEPATITIS B VIRUS Unassigned Not Applicable SURFACE ANTIGEN (HBsAg) Other components below reportable levels > 90.0 *Designates that a specific chemical identity and/or percentage of composition has been withheld as a trade secret. 4. First-aid measures Inhalation Move to fresh air. If breathing is difficult, trained personnel should give oxygen. Call a physician if symptoms develop or persist. Under normal conditions of intended use, this material is not expected to be an inhalation hazard. Skin contact Immediately flush skin with plenty of water. Take off contaminated clothing and wash before reuse. Get medical attention if symptoms occur. Eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. Ingestion If swallowed, rinse mouth with water (only if the person is conscious). If ingestion of a large amount does occur, call a poison control center immediately. Do not induce vomiting without advice from poison control center. Most important The following adverse effects have been noted with therapeutic use of this material: fever; nausea; symptoms/effects, acute and vomiting; diarrhoea; symptoms of hypersensitivity (such as skin rash, hives, itching, and/or delayed difficulty breathing). Material name: TWINRIX ADULT SDS US 1276 Version #: 20 Revision date: 05-29-2018 Issue date: 05-29-2018 2 / 9 Indication of immediate No specific antidotes are recommended. Treat according to locally accepted protocols. For medical attention and special additional guidance, refer to the current prescribing information or to the local poison control treatment needed information center. General information In the case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves. Pre-placement and periodic health surveillance is not usually indicated. The final determination of the need for health surveillance should be determined by local risk assessment. 5. Fire-fighting measures Suitable extinguishing media Water. Foam. Dry chemical powder. Carbon dioxide (CO2). Unsuitable extinguishing None known. media Specific hazards arising from During fire, gases hazardous to health may be formed. the chemical Special protective equipment Self-contained breathing apparatus and full protective clothing must be worn in case of fire. and precautions for firefighters Fire fighting Move containers from fire area if you can do so without risk. equipment/instructions General fire hazards This product is non-flammable. 6. Accidental release measures Personal precautions, Keep unnecessary personnel away. For personal protection, see section 8 of the SDS. protective equipment and emergency procedures Methods and materials for Large Spills: Stop the flow of material, if this is without risk. Dike the spilled material, where this is containment and cleaning up possible. Cover with plastic sheet to prevent spreading. Absorb in vermiculite, dry sand or earth and place into containers. Following product recovery, flush area with water. Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to remove residual contamination. Never return spills in original containers for re-use. For waste disposal, see section 13 of the SDS. Environmental precautions Avoid discharge into drains, water courses or onto the ground. 7. Handling and storage Precautions for safe handling Avoid prolonged exposure. Observe good industrial hygiene practices. Conditions for safe storage, Store in original tightly closed container. Store at 2 to 8 °C (36 to 46 °F). Do not freeze. Dispose of including any incompatibilities properly if frozen. Store away from incompatible materials (see Section 10 of the SDS). 8. Exposure controls/personal protection Occupational exposure limits The following constituents are the only constituents of the product which have a PEL, TLV or other recommended exposure limit. At this time, the other constituents have no known exposure limits. GSK Components Type Value Note NEOMYCIN SULFATE 8 HR TWA 2000 mcg/m3 (CAS 1405-10-3) OHC 1 SKIN SENSITISER 1 REPRODUCTIVE HAZARD SODIUM CHLORIDE (CAS OHC 1 7647-14-5) US. OSHA Specifically Regulated Substances (29 CFR 1910.1001-1050) Components Type Value FORMALDEHYDE 35% STEL 2 ppm SOLUTION (CAS 50-00-0) TWA 0.75 ppm Material name: TWINRIX ADULT SDS US 1276 Version #: 20 Revision date: 05-29-2018 Issue date: 05-29-2018 3 / 9 US. ACGIH Threshold Limit Values Components Type Value Form ALUMINIUM HYDROXIDE TWA 1 mg/m3 Respirable fraction. (CAS 21645-51-2) ALUMINUM PHOSPHATE TWA 1 mg/m3 Respirable fraction. (CAS 7784-30-7) FORMALDEHYDE 35% Ceiling 0.3 ppm SOLUTION (CAS 50-00-0) US. NIOSH: Pocket Guide to Chemical Hazards Components Type Value FORMALDEHYDE 35% Ceiling 0.1 ppm SOLUTION (CAS 50-00-0) TWA 0.016 ppm Biological limit values No biological exposure limits noted for the ingredient(s). Exposure guidelines Appropriate engineering General ventilation normally adequate. controls Individual protection measures, such as personal protective equipment Eye/face protection Not normally needed. If contact is likely, safety glasses with side shields are recommended. Skin protection Hand protection Not normally needed. For prolonged or repeated skin contact use suitable protective gloves. Other Not normally needed. Wear suitable protective clothing as protection against splashing or contamination. Respiratory protection No personal respiratory protective equipment normally required. Use a NIOSH/MSHA approved respirator if there is a risk of exposure to dust/fume at levels exceeding the exposure limits. Thermal hazards Wear appropriate thermal protective clothing, when necessary. General hygiene Always observe good personal hygiene measures, such as washing after handling the material considerations and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants. For advice on suitable monitoring methods, seek guidance from a qualified environment, health and safety professional. 9. Physical and chemical properties Appearance Physical