Material Safety Data Sheet. FUROSEMIDE INJECTION, USP, 10 mg/ml

Transcription

1 1. PRODUCT IDENTIFICATION Common/Trade Name: How Supplied: Chemical Class Chemical Name Furosemide Injection, USP Strength: 10 mg/ml Anthranilic acid derivative Benzoic acid, 5-(aminosulfonyl)-4-chloro-2- [(2-furanylmethyl) amino]-. 4-Chloro-N-furfuryl-5-sulfamoylanthranilic acid Formula Product Type Product Use Distributor Name Distributor Address Manufacturer's Name Address C 12 H 11 ClN 2 O 5 S Prescription Drug Pharmaceutical, Injectable CLARIS LIFESCIENCES INC. CHACHARWADI-VASANA, AHMEDABAD , INDIA. CLARIS INJECTABLES LIMITED CHACHARWADI-VASANA, th Date Prepared 04, February 2015 Page 1 of 6

2 2. COMPOSITION INFORMATION Component mg/ml CAS# Furosemide Sodium Chloride Sodium Hydroxide Sodium Hydroxide q.s. to ph Hydrochloric Acid q.s. to ph Water for Injection q.s. to 1mL q.s.- Quantity Sufficient 3. HAZARDOUS IDENTIFICATION Emergency Overview: In clinical use, this material is used to promote urination. Possible target organs include the kidneys, fetus, DNA and ears. Likely Routes of exposure: Eye contact, inhalation and ingestion. Inhalation: May cause irritation of the upper and lower respiratory tract.. Contact with Skin or Eyes: Causes irritation of the eye. May cause irritation of the skin. Ingestion: May cause irritation of the gastrointestinal tract. Medical Conditions Aggravated by Exposure: Workers with impaired cardiovascular, kidney or liver functions should minimize their exposure to this product. It is strongly recommended that pregnant workers not be exposed to this product. 4. FIRST-AID MEASURES Skin Exposure: Remove contaminated clothing. Flush area with copious quantities of water for 15 minutes. Seek medical attention. Eye Exposure: Flush for 15 minutes with copious quantities of water. Seek medical attention. Inhalation: Remove person to fresh air. Remove contaminated clothing. Seek medical attention. Ingestion: Flush mouth out with water. Seek medical attention. Page 2 of 6

3 NOTES TO HEALTH PROFESSIONALS: Exposure to this product may result in headache, tinnitus, electrolyte imbalance, dry mouth, weakness, lethargy, drowsiness and muscle pains. Dermatitis, urticaria, rash and photosensitivity could be observed. Tachycardia, arrhythmia, hypotension, hypocalemia, hypochloremic alkalosis, nausea and vomiting may be observed as well. See prescribing information.. 5. FIRE-FIGHTING MEASURES: Flash Point: Nonflammable, noncombustible Auto ignition Temperature: Not applicable Flammable Limits (in air by volume, %): Lower: Not applicable Upper: Not applicable Fire Extinguishing Equipment: Water spray, foam, dry chemical or Carbon Dioxide (CO 2 ). Fire Fighting Equipment: Wear self-contained breathing apparatus and protective clothing. Hazardous Combustion Products: When heated, Furosemide solution thermally decomposes to form toxic vapors. (I.e. Carbon Monoxide, Carbon Dioxide and Nitrogen Oxides) 6. ACCIDENTAL RELEASE INFORMATION Spill Cleanup and Disposal: Absorb with suitable material and clean affected area with soap and water. Dispose of materials according to the applicable federal, state, or local regulations. 7. PRECAUTION FOR SAFE HANDLING AND USE Handling: Protect from light by retaining in carton until contents have been used. Storage: No special storage required for hazard control. For product protection store at controlled room temperature of C (59-86 F). Work and Hygiene Practices: As with all chemicals, avoid getting this product ON YOU or IN YOU. Do not eat, drink, smoke or apply cosmetics while handling the product. Wash hands thoroughly after handling. Protective Practices During Maintenance of Contaminated Equipment: When cleaning nondisposable equipment, wear latex or nitrile gloves (double gloving is recommended), goggles, and lab coat. Wash equipment with soap and water. All needles, syringes, vials and other disposable items contaminated with this product should be disposed of properly. Page 3 of 6

4 . 8. EXPOSURE CONTROLS - PERSONAL PROTECTION Ventilation and Engineering Controls: Use with adequate ventilation. Follow standard medical product handling procedures. Respiratory Protection: Under normal conditions of product use, respiratory protection is not required. When required, use a NIOSH approved air purifying respirator with combination P-100 / organic vapor cartridges. Eye Protection: Approved eye protection to safeguard against potential eye contact, irritation or injury is recommended. Depending on conditions of use, a face shield may be necessary. Body Protection: No special body protection required for routine, medical administration of this product. Wear lab coat, gown, or smock, as appropriate for procedure. Product Preparation Instructions for Medical Personnel: Follow standard procedure for handling pharmaceutical materials and recommendations presented on the Package Insert. 9. PHYSICAL AND CHEMICAL PROPERTIES Physical State: Specific Gravity: Appearance: Melting Point/Range: Boiling Point/Range: Evaporation Rate: Vapor Pressure: Solubility in Water: Liquid Approximate to water A clear, colorless to slightly yellow liquid Not applicable Approximately 212 degrees Fahrenheit Not applicable Approximate to water Aqueous solution Vapor Density: Not Applicable ph: Between 8.0 to STABILITY AND REACTIVITY DATA Page 4 of 6

5 Stability: Stable under normal conditions of storage and handling. Materials With Which Substance is Incompatible: This product is generally compatible with other common materials in a medical facility. Hazardous Polymerization: Will not occur. Hazardous Combustion Products: Carbon Monoxide, Carbon Dioxide and Nitrogen Oxides may be released by thermal decomposition. 11. TOXICOLOGICAL INFORMATION Oral (LD50) LD50: 2600 mg/kg oral - rat LD50: 4600 mg/kg oral - mouse LD50: 800 mg/kg oral - rabbit LD50: 1000 mg/kg oral dog Intravenous (LD50) LD50: 800 mg/kg intravenous - rat LD50: 308 mg/kg intravenous - mouse LD50: 400 mg/kg intravenous - rabbit LD50: 300 mg/kg intravenous dog Toxic Dose - Minimum (TDLo) TDLo : 29 mg/kg intravenous human Mutagenicity: Positive in the mouse lymphoma and chromosomal aberration assays. Sodium Chloride is considered mutagenic for mammalian somatic cells, bacteria and yeast. Irritancy of Product: This product is expected to be irritating to eyes and skin. Sensitization to the Product: Repeated exposures may lead to sensitivity to this product. 12. ENVIRONMENTAL IMPACT INFORMATION Environmental Stability: This product will be relatively stable under ambient environmental conditions. Bioaccumulation / Accumulation: No applicable bioaccumulation is expected in the environment. Mobility in Environment: Appreciable volatilization is not expected into the air. Persistence / Degradability: Short-term products of biodegradation are not likely. Long-term degradation products may arise. 13. DISPOSAL INFORMATION Do not mix with other substances. Dispose of in accordance with Federal, state and local regulations. Page 5 of 6

6 14. TRANSPORTATION INFORMATION US DOT (ground): Not considered a DOT regulated material - Non hazardous for shipment. 15. REGULATORY INFORMATION TSCA Status CERCLA Status SARA Status RCRA Status PROP 65 (Calif.) Notes: TSCA Toxic Substance Control Act CERCLA, US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act SARA Superfund Amendments and Reauthorization Act RCRA US EPA, Resource Conservation and Recovery Act Prop 65, California Proposition OTHER DATA The information in this document is believed to be correct as of the date issued. HOWEVER, NO WARRANTY OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, OR ANY OTHER WARRANTY IS EXPRESSED OR IS TO BE IMPLIED REGARDING THE ACCURACY OR COMPLETENESS OF THIS INFORMATION, THE RESULTS TO BE OBTAINED FROM THE USE OF THIS INFORMATION OR THE PRODUCT, THE SAFETY OF THIS PRODUCT, OR THE HAZARDS RELATED TO ITS USE. This information and product are furnished on the condition that the person receiving them shall make his own determination as to the suitability of the product for his particular purpose and on the condition that he assume the risk of his use thereof. Page 6 of 6