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BECONASE AQ NASAL SPRAY 110536 Approved/Revised 23-Mar-2007 Material SDS Number Version 10 GlaxoSmithKline, Corporate Environment, Health & Safety Company Name 980 Great West Road +44-20-8047-5000 UK General Information: +44-1865-407333 Transport Emergency (EU) +1-612-221-3999, Ext 221 Medical Emergency US number, available 24 hours Information and Advice: Multi-language response Brentford, Middlesex TW8 9GS UK +1-888-825-5249 US General Information: +1-703-527-3887 Transport Emergency (non EU) US number, available 24 hours Multi-language response One Franklin Plaza, 200 N 16th Street GlaxoSmithKline, Corporate Environment, Health & Safety Philadelphia, PA 19102-1225 US Percentage CAS RN Ingredients 0.04 to 0.05 5534-09-8 BECLOMETHASONE DIPROPIONATE 99.95 to 99.96 Unassigned NON-HAZARDOUS INGREDIENTS Fire and Explosion This product is classified as non-flammable. Health Caution - Potent pharmaceutical agent. Health effects information is based on hazards of components. May cause steroid withdrawal rash. Environment No information is available about the potential of this product to produce adverse environmental effects. SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING 2. COMPOSITION / INFORMATION ON INGREDIENTS 3. HAZARDS IDENTIFICATION 4. FIRST-AID MEASURES Synonyms BECONASE HAY FEVER (UK) * BECONASE AQUEOUS NASAL SPRAY 42 MCG * BECONASE AQUEOUS NASAL SPRAY 50 MCG * BECONASE AQ NASAL SPRAY 0.042% * BECONASE ALLERGY AQUEOUS NASAL SPRAY * BECOTIDE AQUEOUS NASAL SPRAY * BECLOSOL AQ NASAL * NDC NO 0173-0388-79 * BECLOMETHASONE DIPROPIONATE, FORMULATED PRODUCT Material BECONASE AQ NASAL SPRAY Page 1 / 6 BECONASE AQ NASAL SPRAY 110536 Approved/Revised 23-Mar-2007 Material SDS Number Version 10 Ingestion 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. Inhalation Physical form suggests that risk of inhalation exposure is negligible. Skin Contact 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. Eye Contact Wash immediately with clean and gently flowing water. Continue for at least 15 minutes. Obtain medical attention. NOTES TO HEALTH PROFESSIONALS Medical Treatment 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 Conditions Caused or Aggravated by Exposure Refer to prescribing information for detailed description of medical conditions caused by or aggravated by overexposure to this product. Antidotes No specific antidotes are recommended. Fire and Explosion Hazards Not expected for the product, although the packaging is combustible. Extinguishing Media Water, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers may be ineffective. Special Firefighting Procedures For single units (packages): No special requirements needed. For larger amounts (multiple packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved from fires involving this product and associated packaging, self contained breathing apparatus and full protective equipment are recommended for firefighters. If possible, contain and collect firefighting water for later disposal. Hazardous Combustion Products Toxic, corrosive or flammable thermal decomposition products are expected when the product is exposed to fire. Personal Precautions Wear protective clothing and equipment consistent with the degree of hazard. Environmental Precautions Prevent entry into waterways, sewers, surface drainage systems and poorly ventilated areas. Clean-up Methods Spread an inert absorbent on the spill and place in a suitable, properly labelled container for recovery or disposal. Decontamination Procedures No specific decontamination or detoxification procedures have been identified for this product. HANDLING General Requirements Normal room ventilation is expected to be adequate for routine handling of this product. STORAGE No storage requirements necessary for occupational hazards. Follow product information storage instructions to maintain efficacy. 5. FIRE-FIGHTING MEASURES 6. ACCIDENTAL RELEASE MEASURES 7. HANDLING AND STORAGE Page 2 / 6 BECONASE AQ NASAL SPRAY 110536 Approved/Revised 23-Mar-2007 Material SDS Number Version 10 8. EXPOSURE CONTROLS/PERSONAL PROTECTION INGREDIENT BECLOMETHASONE DIPROPIONATE GSK Occupational Hazard Category 4 GSK Occupational Exposure Limit 6 mcg/m3 (8 HR TWA) SKIN PERSONAL PROTECTIVE EQUIPMENT Eye Protection Wear approved safety glasses with side shields if eye contact is possible. Other Equipment or Procedures Follow all local regulations if personal protective equipment (PPE) is used in the workplace. Wear appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after handling. Appearance Physical Form Aqueous solution. 9. PHYSICAL AND CHEMICAL PROPERTIES 6 to 6.8 pH of Aqueous Solutions Stability This product is expected to be stable. Conditions to Avoid None for normal handling of this product. 11. TOXICOLOGICAL INFORMATION Oral Toxicity Not expected to be toxic following ingestion. Skin Effects Irritation is not expected following direct contact. Pharmacological effects may occur following skin absorption. Eye Effects Minor irritation might occur following direct contact with eyes. Target Organ Effects Adverse effects might occur in the following organ(s) following overexposure: adrenal glands; immune system. Sensitisation Allergic skin reactions might occur following dermal exposure. Assessment based upon information from human exposure. Genetic Toxicity Not expected to be genotoxic under occupational exposure conditions. Carcinogenicity Not expected to produce cancer in humans under occupational exposure conditions. No components are listed as carcinogens by GSK, IARC, NTP or US OSHA. Reproductive Effects Not expected to produce adverse effects on fertility or development under occupational exposure conditions. Pharmacological Effects 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. Other Adverse Effects None known for occupational exposure. 10. STABILITY AND REACTIVITY 12. ECOLOGICAL INFORMATION Page 3 / 6 BECONASE AQ NASAL SPRAY 110536 Approved/Revised 23-Mar-2007 Material SDS Number Version 10 Summary This material contains an active pharmaceutical ingredient that may bioaccumulate in the environment. 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. ECOTOXICITY Aquatic Activated Sludge Respiration IC50: > 97.2 mg/l, 3 Hours, Activated sludge This material contains an active pharmaceutical ingredient that is not toxic to activated sludge microorganisms. Daphnid NOEL: 3.74 mcg/l, 48 Hours, Daphnia magna, Static test 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. Other Species No toxicity to these organisms was observed for the active pharmaceutical ingredient, but the upper range of the test was limited by the low water solubility of the compound. LC50: Measured EC50: > 500 mg/kg, 28 Days, Measured NOEL: 500 mg/kg, 28 Days Terrestrial Earthworm Eisenia foetida, manure worm EC50: > 750 mg/kg, 28 Days, Static test This mixture contains an active pharmaceutical ingredient that is not toxic to earthworms. MOBILITY Solubility This material contains an active pharmaceutical ingredient that for environmental fate predictions has very low solubility in water. Volatility 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. This material contains an active pharmaceutical ingredient that will not readily enter into air from water. Henry's Law Constant 8.00E-07 atm m^3/mol, Calculated at 20 C Adsorption 1.88 to 4, Measured Soil Sediment Sorption (log Koc): 1.61 to 3.73 Estimated Sludge Biomass Distribution Coefficient (log Kd): 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. Partitioning This material contains an active pharmaceutical ingredient with octanol/water partition coefficient data that suggests that for environmental fate predictions the active pharmaceutical ingredient may have the tendency to distribute into fats. PERSISTENCE/DEGRADATION Page 4 / 6 BECONASE AQ NASAL SPRAY 110536 Approved/Revised 23-Mar-2007 Material SDS Number Version 10 Photolysis This material contains an active pharmaceutical ingredient that is unlikely to undergo photodegradation. UV/Visible Spectrum: 240 Biodegradation This material contains an active pharmaceutical ingredient that is not readily biodegradable (as defined by 1993 OECD Testing Guidelines). Percent Degradation: 3 %, 28 days, Modified Sturm test., Activated sludge Aerobic - Ready Aerobic - Soil Percent Degradation: 21.9 to 61.5 %, 64 days BIOACCUMULATION This material contains an active pharmaceutical ingredient that will have a tendency to bioaccumulate in the food chain. 1806 Calculated Bioconcentration Factor: Hydrolysis This material contains an active pharmaceutical ingredient that has been shown to be chemically unstable in water. Hydrolysis may be a significant depletion mechanism. Half-Life, Neutral: 166 Hours, Measured Half-Life, Basic: 2.9 Hours, Measured Half-Life, Acidic: > 1 Years, Measured 16. OTHER INFORMATION References GSK Hazard Determination Disposal Recommendations 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. Regulatory Requirements Observe all local and national regulations when disposing of this product. 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 13. DISPOSAL CONSIDERATIONS UN Classification and Labelling Transport Information Transportation and shipping of this product is not restricted. It has no known, significant hazards requiring special packaging or labelling for air, maritime, US or European ground transport purposes. 15. REGULATORY INFORMATION EU Classification and Labelling Exempt from requirements of EU Dangerous Preparations directive - product regulated as a medicinal product, cosmetic product or medical device. US OSHA Standard (29 CFR Part 1910.1200) Classification This dosage form is exempt from the requirements of the OSHA Hazard Communication Standard. 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. Other US Regulations TSCA Status Exempt Page 5 / 6 BECONASE AQ NASAL SPRAY 110536 Approved/Revised 23-Mar-2007 Material SDS Number Version 10 23-Mar-2007 Date Approved/Revised 10 SDS Version Number SDS Sections Updated Sections Subsections IDENTIFICATION OF SUBSTANCE / PREPARATION AND OF COMPANY 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. Page 6 / 6
