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FLOVENT HFA 126601 Approved/Revised 21-Jul-2008 Material SDS Number Version 13 SAFETY DATA SHEET FLOVENT HFA Material 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING space FLOVENT HFA INHALATION AEROSOL * FLIXOTIDE AEROSOL 134A * FLIXOTIDE INHALER CFC FREE * FLIXOTIDE EVOHALER * ATEMUR MITE INHALER HFA 134A 50 MCG * ATEMUR MITE INHALER HFA 134A 125 MCG * ATEMUR FORTE INHALER HFA 134A 250 MCG * AXOTIDE INHALER HFA * BREXOVENT INHALER HFA * FLUTIDE MITE 50 DOSIER-AEROSOL * FLUTIDE 125 DOSIER-AEROSOL FCKW-FREI * FLUTIDE FORTE 250 DOSIER-AEROSOL FCKW-FREI * FLIXOTAIDE INHALER HFA * NDC NO: 0173-0718-20 * NDC NO: 0173-0719-20 * NDC NO: 0173-0720-20 * FLUTICASONE PROPIONATE, FORMULATED PRODUCT Synonym(s) space GlaxoSmithKline, Corporate Environment, Health & Safety 980 Great West Road Brentford, Middlesex TW8 9GS UK Company Name space UK General Information: +44-20-8047-5000 Transport Emergency (EU) +44-1865-407333 Medical Emergency +1-612-221-3999, Ext 221 Information and Advice: US number, available 24 hours Multi-language response space GlaxoSmithKline, Corporate Environment, Health & Safety One Franklin Plaza, 200 N 16th Street Philadelphia, PA 19102-1225 US space US General Information: +1-888-825-5249 Transport Emergency (non EU) +1-703-527-3887 US number, available 24 hours Multi-language response space EC-No. Ingredients CAS # 1,1,1,2-TETRAFLUOROETHANE 811-97-2 Percent 99.66 to 99.91 FLUTICASONE PROPIONATE 80474-14-2 0.09 to 0.34 . 2. COMPOSITION / INFORMATION ON INGREDIENTS space This product is classified as non-flammable. Fire and Explosion 3. HAZARDS IDENTIFICATION space Caution - Potent pharmaceutical agent. Health effects information is based on hazards of components. May cause steroid withdrawal rash. Health space No information is available about the potential of this product to produce adverse environmental effects. Environment space Page 1 / 5 FLOVENT HFA 126601 Approved/Revised 21-Jul-2008 Material SDS Number Version 13 Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention. Ingestion 4. FIRST-AID MEASURES space Physical form suggests that risk of inhalation exposure is negligible. Inhalation space Using appropriate personal protective equipment, remove contaminated clothing and flush exposed area with large amounts of water. Obtain medical attention if skin reaction occurs, which may be immediate or delayed. Skin Contact space Wash immediately with clean and gently flowing water. Continue for at least 15 minutes. Obtain medical attention. Eye Contact space Treat according to locally accepted protocols. For additional guidance, refer to the current prescribing information or to the local poison control information centre. Medical treatment in cases of overexposure should be treated as an overdose of glucocorticosteroid. Medical Treatment NOTES TO HEALTH PROFESSIONALS space Refer to prescribing information for detailed description of medical conditions caused by or aggravated by overexposure to this product. Medical Conditions Caused or Aggravated by Exposure space No specific antidotes are recommended. Antidotes space Aerosol containers may violently rupture when exposed to the heat of fire. This product is non-flammable. Fire and Explosion Hazards . 5. FIRE-FIGHTING MEASURES space Since toxic, corrosive or flammable vapours might be evolved from fires involving this material, self contained breathing apparatus and full protective equipment are recommended for firefighters. Special Firefighting Procedures space Toxic, corrosive or flammable thermal decomposition products are expected when the product is exposed to fire. Hazardous Combustion Products space Wear protective clothing and equipment consistent with the degree of hazard. Ventilate area to dispel vapours present. Instruct all personnel not involved in clean-up operations to keep at a designated safe distance. Personal Precautions 6. ACCIDENTAL RELEASE MEASURES space Do not allow this material to enter surface drainage systems, sewers and poorly ventilated areas. Environmental Precautions space No specific decontamination or detoxification procedures have been identified for this product. Water can be used for clean-up and decontamination operations. Decontamination Procedures space No special control measures required for the normal handling of this product. Normal room ventilation is expected to be adequate for routine handling of this product. General Requirements HANDLING 7. HANDLING AND STORAGE space No storage requirements necessary for occupational hazards. Follow product information storage instructions to maintain efficacy. Store in a well ventilated area away from heat. The recommended temperature for storage is 15-25 °C. STORAGE space FLUTICASONE PROPIONATE 4 3 mcg/m3 (8 HR TWA) SKIN INGREDIENT GSK Occupational Hazard Category GSK Occupational Exposure Limit 8. EXPOSURE CONTROLS / PERSONAL PROTECTION space Page 2 / 5 FLOVENT HFA 126601 Approved/Revised 21-Jul-2008 Material SDS Number Version 13 Consider use of enclosures. Containment ENGINEERING CONTROLS space Wear approved safety glasses with side shields if eye contact is possible. Eye Protection PERSONAL PROTECTIVE EQUIPMENT space Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after handling. Other Equipment or Procedures space Aerosol container. Packaging Appearance 9. PHYSICAL AND CHEMICAL PROPERTIES space Non-flammable. Flash Point space This product is expected to be stable. Stability 10. STABILITY AND REACTIVITY space Avoid direct sunlight, conditions that might generate heat and sources of ignition. Conditions to Avoid space This material is a selective glucocorticoid receptor agonist. Adverse effects of overexposure might include: suppression of adrenal glands; temporary decrease in white blood cell counts; symptoms of hypersensitivity (such as skin rash, hives, itching, and difficulty breathing); increased susceptibility to infection. Pharmacological Effects 11. TOXICOLOGY INFORMATION space Adverse effects might occur in the following organ(s) following overexposure: adrenal glands; immune system. Target Organ Effects space Not expected to be toxic following ingestion. Oral Toxicity Routes of Exposure space Irritation is not expected following direct contact. Pharmacological effects may occur following skin absorption. Skin Effects space Minor irritation might occur following direct contact with eyes. Eye Effects space Allergic skin reactions might occur following dermal exposure. Assessment based upon information from human exposure. Sensitisation space Not expected to be genotoxic under occupational exposure conditions. Genetic Toxicity space Not expected to produce cancer in humans under occupational exposure conditions. No components are listed as carcinogens by GSK, IARC, NTP or US OSHA. Carcinogenicity space Not expected to produce adverse effects on fertility or development under occupational exposure conditions. Reproductive Effects space None known for occupational exposure. Other Adverse Effects space This material contains an active pharmaceutical ingredient that has had limited testing and no adverse environmental effects were observed in the tests conducted. There is insufficient information to determine the scope of the environmental effects this material may cause. Until there is additional testing to determine other potential adverse effects on the environment, appropriate precautions should be taken to limit release of this compound to the environment. Local regulations and procedures should be consulted prior to environmental release. Specific information on the active pharmaceutical ingredient is provided below. Summary 12. ECOLOGICAL INFORMATION space ECOTOXICITY Aquatic Activated Sludge Respiration This material contains an active pharmaceutical ingredient that is not toxic to activated sludge microorganisms. space IC50: > 1000 mg/l, 3 Hours, Activated sludge space Page 3 / 5 FLOVENT HFA 126601 Approved/Revised 21-Jul-2008 Material SDS Number Version 13 Daphnid No toxicity to daphnids was observed for the active pharmaceutical ingredient in this mixture, but the upper range of the test was limited by the low water solubility of this compound. space EC50: > 0.55 mg/l, 48 Hours, Daphnia magna, Static test space Terrestrial Earthworm This mixture contains an active pharmaceutical ingredient that is not toxic to earthworms. space EC50: > 1000 mg/kg, 28 Days, Eisenia foetida, manure worm, space This material contains an active pharmaceutical ingredient that for environmental fate predictions has very low solubility in water. Solubility MOBILITY space This material contains an active pharmaceutical ingredient that will not readily enter into the air from hard surfaces or from a container of the pure substance. Volatility space This material contains an active pharmaceutical ingredient that is likely to adsorb to soil or sediment. This material contains an active pharmaceutical ingredient that is likely to adsorb to sludges and other biomass. Adsorption space Soil Sediment Sorption (log Koc): 3.41 to 3.83, Measured space Sludge Biomass Distribution Coefficient (log Kd): 3.13 to 3.55 Estimated space This material contains an active pharmaceutical ingredient with octanol/water partition coefficient data that suggests that for environmental fate predictions the active pharmaceutical ingredient will not have the tendency to distribute into fats. Partitioning space This material contains an active pharmaceutical ingredient that has been shown to be chemically stable in water. Hydrolysis is unlikely to be a significant depletion mechanism. Hydrolysis PERSISTENCE/DEGRADATION space Half-Life, Neutral: > 1 Years, Measured space This material contains an active pharmaceutical ingredient that is not readily biodegradable but is inherently biodegradable (as defined by 1993 OECD Testing Guidelines) and is not expected to persist in the environment. Biodegradation space Aerobic - Ready Percent Degradation: < 44 %, 28 days space Aerobic - Soil Percent Degradation: 9 to 50 %, 64 days space This material contains an active pharmaceutical ingredient that will not have a tendency to bioaccumulate in the food chain. Bioaccumulation space Collect for recycling or recovery if possible. The disposal method for rejected products/returned goods must ensure that they cannot be re-sold or re-used. The recommended method of disposal is incineration. Wherever possible, disposal should be in an on-site licenced chemical incinerator, if allowed by the incinerator licence or permit. If no on-site incinerator is available, dispose of material in a licenced commercial chemical incinerator. Disposal Recommendations 13. DISPOSAL CONSIDERATIONS space Observe all local and national regulations when disposing of this material. Regulatory Requirements space The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous goods for transport. 14. TRANSPORT INFORMATION space Page 4 / 5 FLOVENT HFA 126601 Approved/Revised 21-Jul-2008 Material SDS Number Version 13 UN Classification and Labelling Proper Shipping Name Subsidiary Risk Packing Group UN Number Class/Division Aerosols, non-flammable UN 1950 2.2 None Not applicable Risk Label(s) Class 2.2 Compressed Gas space Classification and Labelling See IATA Special Provision A98. International Air Transport (IATA Requirements) space Classification and Labelling International Maritime Transport (IMDG Requirements) See IMDG Special Provision 190. space Classification and Labelling See US DOT Special Permit 14254. US Domestic Transport (DOT Requirements) space Classification and Labelling See ADR Special Provision 190. European Ground Transport (ADR/RID Requirements) space The information included below is an overview of the major regulatory requirements. It should not be considered to be an exhaustive summary. Local regulations should be consulted for additional requirements. 15. REGULATORY INFORMATION space Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product, cosmetic product or medical device. EU Classification and Labelling space This dosage form is exempt from the requirements of the OSHA Hazard Communication Standard. Classification US OSHA Standard (29 CFR Part 1910.1200) space Exempt TSCA Status Other US Regulations space GSK Hazard Determination References 16. OTHER INFORMATION space 13 SDS Version Number space SDS Sections Updated Sections Subsections COMPOSITION / INFORMATION ON INGREDIENTS IDENTIFICATION OF SUBSTANCE / PREPARATION AND OF COMPANY space Page 5 / 5
