NEBULES INHALATION SOLUTION,

Transcription

1 SAFETY DATA SHEET 1. Product and company identification Product name Other name Recommended use and Limitations on use Recommended use Medicinal Product. VENTOLIN NEBULES INHALATION SOLUTION, 0.083% VENTOLIN NEBULES 2.5 MG * VENTOLIN NEBULES 5.0 MG * VENTOLIN NEBULES - HOSPITAL PACK 2.5 MG * VENTOLIN NEBULES - HOSPITAL PACK 5.0 MG * AEROLIN NEBULES * SULTANOL NEBULES * SULTANOL NEBULIZER SOLUTION * SULTANOL FERTIGINHALAT 1.25 MG/2.5 ML * SULTANOL FORTE FERTIGINHALAT 2.5 MG/2.5 ML * VENTOLINE NEBULIZER SOLUTION (ANZ) * (SALBUTAMOL SULPHATE), FORMULATED PRODUCT GSK New Zealand Pharmaceuticals and Vaccines Level 11, Zurich House 21 Queen Street Auckland New Zealand 1010 General Information Phone Number (Normal Business Hours): GSK New Zealand Consumer Healthcare Level 11, Zurich House 21 Queen Street Auckland 1010 New Zealand General Information Phone Number (Normal Business Hours): CHEMTREC EMERGENCY PHONE NUMBERS - TRANSPORT EMERGENCIES Customer Number: CCN9484 Local in-country +(64) US / International toll call available 24 hrs/7 days; multi-language response Address: msds@gsk.com Website: Limitations on use 2. Hazards identification GHS classification Physical hazards Health hazards Environmental hazards Label elements Symbols Signal word Hazard statement Other hazards 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. No other uses are advised. Not classified. Not classified. Not classified. None. None. The mixture does not meet the criteria for classification. This product is non-flammable. Caution - Pharmaceutical agent. See section 11 for additional information on health hazards. 3. Composition/information on ingredients Substance or mixture Mixture 1 / 6

2 Chemical property Synonyms CAS Number Concentration (%) ALBUTEROL SULPHATE * SALBUTAMOL HEMISULPHATE * AH 3365F * SALBUTAMOL SULPHATE * BIS [ (TERT- BUTYL) (BETA, 3, 4- TRIHYDROXYPHENETHYL) AMMONIU M] SULFATE Other components below reportable levels First aid measures Inhalation Skin contact Eye contact Ingestion Potential delayed effects Personal protection for first-aid responders Notes to physician 5. Fire-fighting measures Extinguishing media Extinguishing media to avoid HAZCHEM Code Number Specific hazards during fire fighting Special fire fighting procedures Protection of fire-fighters Hazards from combustion products Specific methods General fire hazards 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. Immediately flush skin with plenty of water. Take off contaminated clothing and wash before reuse. Get medical attention if symptoms occur. Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. If swallowed, rinse mouth with water (only if the person is conscious). If ingestion of a large amount does occur, call a poison control centre immediately. Do not induce vomiting without advice from poison control center. The following adverse effects have been noted with therapeutic use of this material: headache; changes in blood pressure; altered heart rate and pulse. 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. No specific antidotes are recommended. Treat according to locally accepted protocols. For additional guidance, refer to the current prescribing information or to the local poison control information centre. Water. Foam. Dry chemical powder. Carbon dioxide (CO2). None. During fire, gases hazardous to health may be formed. Move containers from fire area if you can do so without risk. Self-contained breathing apparatus and full protective clothing must be worn in case of fire. During fire, gases hazardous to health may be formed. Use standard firefighting procedures and consider the hazards of other involved materials. This product is non-flammable. 6. Accidental release measures Personal precautions, protective equipment and emergency procedures Environmental precautions Spill cleanup methods Keep unnecessary personnel away. For personal protection, see section 8. Avoid discharge into drains, water courses or onto the ground. Large Spills: Stop the flow of material, if this is without risk. Dike the spilled material, where this is possible. 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 to original containers for re-use. For waste disposal, see section 13 of the SDS. 7. Handling and storage Handling Precautions Safe handling advice Prevention of fire and explosion Use personal protection recommended in Section 8 of the SDS. Avoid prolonged exposure. No specific recommendations. 2 / 6

3 Local and general ventilation Storage Suitable storage conditions Incompatible materials Safe packaging materials Provide adequate ventilation. Store away from incompatible materials (see Section 10 of the SDS). Strong oxidising agents. For further information, please refer to section 10. Store in original tightly closed container. 8. Exposure controls/personal protection Exposure limits GSK Components Type Value (CAS ) Biological limit values Exposure guidelines Engineering controls Personal protective equipment Respiratory protection Hand protection Skin protection Eye/face protection Radioactive or thermal hazards Hygiene measures 8 HR TWA 10 mcg/m3 OHC 4 No biological exposure limits noted for the ingredient(s). General ventilation normally adequate. No personal respiratory protective equipment normally required. When workers are facing concentrations above the exposure limit they must use appropriate certified respirators. Not normally needed. For prolonged or repeated skin contact use suitable protective gloves. Not normally needed. Wear suitable protective clothing as protection against splashing or contamination. Not normally needed. If contact is likely, safety glasses with side shields are recommended. Follow standard monitoring procedures. Always observe good personal hygiene measures, such as washing after handling the material 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 Odour Physical state Form Colour Odour threshold ph Melting point/freezing point Boiling point, initial boiling point, and boiling range Flash point Auto-ignition temperature Flammability (solid, gas) Liquid. Liquid. Not applicable. Flammability limit - lower (%) Flammability limit - upper (%) Explosive limit - lower (%) Explosive limit upper (%) Vapour pressure Vapour density Evaporation rate Relative density Density 3 / 6

4 Solubility(ies) Solubility (water) Partition coefficient (n-octanol/water) Decomposition temperature Other data Explosive properties Oxidising properties 10. Stability and reactivity Reactivity Stability Conditions to avoid Incompatible materials Hazardous decomposition products Possibility of hazardous reactions Not explosive. Not oxidising. The product is stable and non-reactive under normal conditions of use, storage and transport. Material is stable under normal conditions. Contact with incompatible materials. Strong oxidising agents. Irritating and/or toxic fumes and gases may be emitted upon the product's decomposition. No dangerous reaction known under conditions of normal use. 11. Toxicological information Information on likely routes of exposure Ingestion Expected to be a low ingestion hazard. Inhalation Skin contact Eye contact Acute toxicity Components Under normal conditions of intended use, this material is not expected to be an inhalation hazard. Avoid contact with eyes. Species (CAS ) Acute Test results Oral LD50 Rat 660 mg/kg Chronic Oral LOEL Dog 2 mg/kg/day, 1 years Subacute Oral LOEL Rat 30 mg/kg/day, 30 Day Subchronic Inhalation LOEL Rat 600 mcg/kg/day, 26 weeks NOAEL Dog 1710 mcg/kg/day, 13 weeks Rat * Estimates for product may be based on additional component data not shown. 512 mcg/kg/day, 6 months 1.9 mg/kg/day, 13 weeks NOEL Dog 220 mcg/kg/day, 26 weeks Routes of exposure Symptoms Skin corrosion/irritation Serious eye damage/eye irritation Respiratory sensitiser Skin sensitiser Germ cell mutagenicity Inhalation. Ingestion. Skin contact. Eye contact. The following adverse effects have been noted with therapeutic use of this material: headache; changes in blood pressure; altered heart rate and pulse. This product is not expected to cause skin sensitisation. 4 / 6

5 Mutagenicity Carcinogenicity Toxic to reproduction Specific target organ toxicity - single exposure Specific target organ toxicity - repeated exposure Aspiration hazard Chronic effects Relevant negative data Other information Ames Chromosomal Aberration Assay In Vitro Mouse micronucleus test Species: Mouse Species: Rat Components in this product have been shown to cause birth defects and reproductive disorders in laboratory animals. Heart. Heart. Not an aspiration hazard. Caution - Pharmaceutical agent. Occupational exposure to the substance or mixture may cause adverse effects. 12. Ecological information Ecotoxicological data Components (CAS ) Aquatic Acute Activated Sludge Respiration Crustacea Chronic Crustacea IC50 EC50 NOEC LOEC NOEC Species Residential sludge Water flea (Daphnia magna) Water flea (Daphnia magna) Water flea (Ceriodaphnia dubia) Water flea (Ceriodaphnia dubia) Test results > 1000 mg/l, 3 days OECD mg/l, 48 hours Static test, OECD mg/l, 48 hours Static test > 100 mg/l, 8 days Static renewal test, EPA mg/l, 8 days * Estimates for product may be based on additional component data not shown. Ecotoxicity Persistence and degradability Hydrolysis Half-life (Hydrolysis-neutral) The product is not classified as environmentally hazardous. However, this does not exclude the possibility that large or frequent spills can have a harmful or damaging effect on the environment. No data is available on the degradability of this product. Biodegradability Percent degradation (Aerobic biodegradation-ready) Percent degradation (Aerobic biodegradation-soil) Bioaccumulation Partition coefficient n-octanol/water (log Kow) Bioconcentration factor (BCF) Mobility No data available. > 1 years Measured 1 %, 28 days Modified Sturm test %, 64 days 1 Calculated 5 / 6

6 Adsorption Soil/sediment sorption - log Koc Volatility Henry's law Distribution Octanol/water distribution coefficient log DOW -1.5, ph 5-2.8, ph 7-2.8, ph 9 Other hazardous effects 13. Disposal considerations Disposal methods/information Special precautions 14. Transport information IATA Not regulated as dangerous goods. IMDG Not regulated as dangerous goods. Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code 15. Regulatory information Applicable regulations Measured 0 atm m^3/mol Calculated Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Do not discharge into drains, water courses or onto the ground. Dispose in accordance with all applicable regulations. Dispose in accordance with all applicable regulations. Not established. Additional information is given in the Safety Data Sheet. All ingredients in this product are listed on the New Zealand Inventory of Chemicals (NZIoC) or are exempt. This product is a medicine. (TT /1). (TT /1a). Poison Standard (SUSMP) Schedule: (S4) Prescription Only Medicine. 16. Other information References Issued by Company name Prepared by GSK Product Stewardship. Disclaimer Issue date Revision date Revision information GSK Hazard Determination GSK The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine the applicability of this information and the suitability of the material or product for any particular purpose. 04-November November-2016 Product and Company Identification: Product and Company Identification Composition/Information on Ingredients: Physical & Chemical Properties: Ecological Information: Mobility Transport Information: Agency Name, Packaging Type, and Transport Mode Selection HazReg Data: International Inventories 6 / 6