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LANOXIN TABLETS 110565 Approved/Revised 18-Apr-2008 Material SDS Number Version 11 SAFETY DATA SHEET LANOXIN TABLETS Material 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING space LANOXIN TABLETS 0.125 MG * LANOXIN TABLETS 0.25 MG * LANACORDIN COMPRIMIDOS * LENOXIN MITE TABLETS 125 MG * LENOXIN TABLETS 250 MG * NDC NO 0173-0242-55 * NDC NO 0173-0242-56 * NDC NO 0173-0242-75 * NDC NO 0173-0249-55 * NDC NO 0173-0249-56 * NDC NO 0173-0249-75 * NDC NO 0173-0249-80 * DIGOXIN, 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. Other components below reportable levels >99 Ingredients CAS # DIGOXIN 20830-75-5 244-068-1 Percent 0.13 . 2. COMPOSITION / INFORMATION ON INGREDIENTS space Expected to be non-combustible. Fire and Explosion 3. HAZARDS IDENTIFICATION space Caution - Potent pharmaceutical agent. Exposure might occur via skin; ingestion; eyes. Possible effects of overexposure in the workplace include: cardiovascular effects. Health effects information is based on hazards of components. Health space No information is available about the potential of this product to produce adverse environmental effects. Environment space 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 Page 1 / 5 LANOXIN TABLETS 110565 Approved/Revised 18-Apr-2008 Material SDS Number Version 11 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 Medical treatment in cases of overexposure should be treated as an overdose of a cardiac glycoside. Treat according to locally accepted protocols. For additional guidance, refer to the local poison control information centre. Medical Treatment NOTES TO HEALTH PROFESSIONALS space 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. Health Surveillance Procedures space For medical treatment in cases of overexposure, a recommended antidote would be Digibind. The decision as to whether the severity of poisoning requires administration of any antidote and actual dose required should be made by qualified medical personnel. For the latest information, refer to the local poison control information centres. Antidotes space Not expected for the product, although the packaging is combustible. Fire and Explosion Hazards . 5. FIRE-FIGHTING MEASURES space Water, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers may be ineffective. Extinguishing Media space 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. Special Firefighting Procedures space Toxic, corrosive or flammable thermal decomposition products are expected when the product is exposed to fire. Hazardous Combustion Products space Use protective clothing during clean-up prior to disposal of spilled product. Personal Precautions 6. ACCIDENTAL RELEASE MEASURES space For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage systems. Environmental Precautions space Collect and place it in a suitable, properly labelled container for recovery or disposal. Clean-up Methods space Water can be used for clean-up and decontamination operations. No specific decontamination or detoxification procedures have been identified for this product. Decontamination Procedures space Avoid breaking or crushing tablets. General Requirements HANDLING 7. HANDLING AND STORAGE space No storage requirements necessary for occupational hazards. Follow product information storage instructions to maintain efficacy. STORAGE space DIGOXIN 5 1 mcg/m3 (8 HR TWA) INGREDIENT GSK Occupational Hazard Category GSK Occupational Exposure Limit 8. EXPOSURE CONTROLS / PERSONAL PROTECTION space Page 2 / 5 LANOXIN TABLETS 110565 Approved/Revised 18-Apr-2008 Material SDS Number Version 11 The active ingredient was formerly assigned to OHC 4 with the Highly Potent notation. An Exposure Control Approach (ECA) is established for operations involving this material based upon the OEL/Occupational Hazard Category and the outcome of a site- or operation-specific risk assessment. Refer to the Exposure Control Matrix for more information about how ECA's are assigned and how to interpret them. Special considerations apply in the planning, design, review and implementation of controls - seek specialist assistance from local occupational hygienist or safety department. Exposure Controls ENGINEERING CONTROLS space Open handling may result in overexposure. It is strongly advised that dedicated areas and containment, such as glove boxes, isolators, and enclosed material transfer systems be used to prevent personnel exposure and spread of contamination. Containment space Local exhaust ventilation (LEV) is not appropriate at this level, since total containment should usually be used. Ventilation space Strict control of access to the working area is essential. Only trained personnel should enter the area during operations. Adopt procedures to prevent contamination of working materials and adjacent areas. Administrative space When isolation is not possible, chemical splash goggles or equivalent eye protection must be used with other applicable protective equipment. Eye Protection PERSONAL PROTECTIVE EQUIPMENT space Care must be exercised if insufficient data are available and further guidance should be sought from your local EHS department. Glove selection must take into account any solvents and other hazards present. The selection of gloves for a specific activity must be based on the material's properties and on possible permeation and degradation that may occur under the circumstances of use. Potential allergic reactions can occur with certain glove materials (e.g. Latex) and therefore these should be avoided. Gloves space When isolation is not possible, respiratory protective equipment (RPE) should be combined with applicable protective equipment. Respirators space Follow all local regulations if personal protective equipment (PPE) is used in the workplace. When isolation is not possible in production areas, applicable protective equipment must be used. Consider additional control procedures for maintenance, cleaning and emergencies. Other Equipment or Procedures space Tablet. Physical Form Appearance 9. PHYSICAL AND CHEMICAL PROPERTIES space This product is expected to be stable. Stability 10. STABILITY AND REACTIVITY space None for normal handling of this product. Conditions to Avoid space This material is a cardiac glycoside. Pharmacological Effects 11. TOXICOLOGY INFORMATION space Adverse effects might occur in the following organ(s) following overexposure: heart. Target Organ Effects space Not expected to be toxic following ingestion. Oral Toxicity Routes of Exposure space No studies have been conducted. Inhalation Toxicity space Irritation is not expected following direct contact. Skin Effects space Irritation is not expected following direct contact with eyes. Eye Effects space Sensitisation (allergic skin reaction) is not expected. Sensitisation space Not expected to be genotoxic under occupational exposure conditions. Genetic Toxicity space 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 The following adverse effects have been noted with therapeutic use of this material: symptoms of hypersensitivity (such as skin rash, hives, itching, and/or difficulty breathing). Other Adverse Effects space Page 3 / 5 LANOXIN TABLETS 110565 Approved/Revised 18-Apr-2008 Material SDS Number Version 11 This material contains an active pharmaceutical ingredient that has been tested and which may be harmful if released directly to the environment. Consult the MSDS of the active ingredient for specific information about potential environmental effects. Appropriate precautions should be taken to limit release of this mixture 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: > 100 mg/l, 3 Hours, Activated sludge space NOEC: 100 , 3 Hours, Activated sludge space Algal No toxicity to algae 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 the compound. space IC50: > 10 mg/l, 72 Hours, Selenastrum capricornutum, green algae space NOEC: 10 mg/l, 72 Hours, Selenastrum capricornutum, green algae space Daphnid This material contains an active pharmaceutical ingredient that is harmful to daphnids. This material contains an active pharmaceutical ingredient that is not toxic to daphnids in chronic toxicity studies. space EC50: 24.2 mg/l, 24 Hours, Daphnia magna, Static test space Chronic LOEC: > 10 mg/l, 7 Days, Ceriodaphnia dubia, Static renewal test space Chronic NOEC: 10 mg/l space Fish This material contains an active pharmaceutical ingredient that is toxic to fish. space Adult Oncorhyncus mykiss, rainbow trout space EC50: 2.9 mg/l, 96 Hours, Static test space Adult Oncorhyncus mykiss, rainbow trout space NOEC: 0.56 mg/l, 96 Hours, Static test space This material contains an active pharmaceutical ingredient that for environmental fate predictions has limited 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. This material contains an active pharmaceutical ingredient that will not readily enter into air from water. Volatility space Henrys Law Constant < 1.00E-16 atm m3/mol, Estimated space This material contains an active pharmaceutical ingredient that is not likely to adsorb to soil or sediment if released directly to the environment. This material contains an active pharmaceutical ingredient that is not likely to adsorb to sludge or biomass if released directly to the environment. Adsorption space Sludge Biomass Distribution Coefficient (log Kd): 1.78 Measured at pH 7 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 Page 4 / 5 LANOXIN TABLETS 110565 Approved/Revised 18-Apr-2008 Material SDS Number Version 11 This mixture contains an active pharmaceutical ingredient that is likely to undergo photodegradation. Photolysis PERSISTENCE/DEGRADATION space UV/Visible Spectrum: 220 nm space This mixture 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 - Inherent Percent Degradation: > 99 %, 14 days, Zahn-Wellens, Activated sludge 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. 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 product. 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 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. 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 11 SDS Version Number space SDS Sections Updated Sections Subsections COMPOSITION / INFORMATION ON INGREDIENTS space 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. space Page 5 / 5
