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MATERIAL SAFETY DATA SHEET (MSDS) 2525 McGaw Ave Irvine, CA 92614, USA (949) 660-2000 Page 1 of 6 HMIS (USA) Health Hazard: Fire Hazard: Reactivity: Special: 1 1 1 Allergen CEFUROXIME FOR INJECTION USP AND DEXTROSE INJECTION USP B. Braun Catalog No: 3112-11, 3114-11 Revision Date: May 17, 2006 EMERGENCY OVERVIEW - ALLERGEN SECTION 1- IDENTIFICATION Drug Chamber Common Name: Cefuroxime Sodium Formula: C16H15N4NaO8S Synonym: N/F Chemical Name: 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3[[(aminocarbonyl)oxy]methyl]-7-[[2-furanyl(methoxyimino)acetyl]amino]-8oxo-, monosodium salt [6R-[6alpha, 7beta(Z)]]- CAS Number: 56238-63-2 Chemical Family: Cephalosporin Therapeutic Category: Antibacterial RTECS Number: XI0330000 Diluent Chamber Formula: C6H12O6/H2O Common Name: Dextrose Injection Synonym: Glucose Solution, Sugar Solution, Cerelose Solution Chemical Name: N/A CAS Number: 50-99-7 (Dextrose) Chemical Family: Table Sugar Therapeutic Category: None RTECS Number: N/A SECTION 2- INGREDIENT INFORMATION Drug Chamber Principle Component: Cefuroxime Sodium Percent: Pure Material-Solid Exposure Limit: N/F MATERIAL SAFETY DATA SHEET (MSDS) Page 2 of 6 Diluent Chamber Principle Component: Minor Component: Water Dextrose Percent: 95% Percent: < 5% Exposure Limit: N/F SECTION 3-HEALTH HAZARD INFORMATION Cefuroxime Sodium Usual Adult Dose: Cefuroxime is administered by intravenous infusion; doses range from 750 mg to 1.5 grams every 8 hours. Adverse Effects: Adverse effects of Cephalosporins may include nausea; vomiting; taste alteration; decrease salivation; heartburn; decrease appetite; severe abdominal cramps, tenderness, or pain; diarrhea; which may be watery, bloody or severe; fever; unusual bruising or bleeding; sore mouth or tongue; and anal or genital itching. Drinking alcohol or using alcohol-containing preparations while exposed to this material may cause abdominal cramps, nausea, vomiting, headache, weakness, and flushing. Possible allergic reaction to material if inhaled, ingested or in contact with skin. Overdose Effect: Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis. Acute: Possible eye, skin, gastrointestinal and/or respiratory tract irritation. Chronic: Possible hypersensitization, antibiotic-associated pseudo membranous colitis, and super infections. Inhalation: May cause irritation. Remove to fresh air. Eye: May cause irritation. Flush with copious quantities of water for at least fifteen minutes. Skin: May cause irritation. Flush with copious quantities of water. Ingestion: May cause irritation. Flush out mouth with water. This material is poorly absorbed from the gastrointestinal tract. Medical Conditions Aggregated by Exposure: Hypersensitivity to material, active alcoholism, history of bleeding disorders, kidney function impairment, and gastrointestinal disease, especially ulcerative colitis, regional enteritis, or antibiotic-associated colitis. Cross Sensitivity: Individuals sensitive to penicillin, penicillin derivatives, penicillamine, other cephalosporins, or cephamycin may be sensitive to this material also. Pregnancy Comments: Adequate and well-controlled pregnancy studies in humans have not been done; however, studies in rats and mice at doses 23 times the recommended human dose have not indicated that Cefuroxime axetil causes fetal harm. Pregnancy Category: B MATERIAL SAFETY DATA SHEET (MSDS) Dextrose Injection Page 3 of 6 Non-hazardous SECTION 4 – FIRST AID MEASURES Cefuroxime Sodium General: Remove from exposure. Remove contaminated clothing. Person developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention. If person is not breathing, give artificial respiration. If breathing is difficult give oxygen. Obtain medical attention. Overdose Treatment: Treatment is symptomatic and supportive and may include: (1) For acute hypersensitivity – Administer the usual agents (antihistamines, corticosteroids, or epinephrine, or other pressor amines), oxygen, and airway management, including intubation. (2) For antibiotic-associated pseudo membranous colitis – Moderate to severe cases may require fluid, electrolyte and protein replacement. Oral doses of metronidazole, bacitracin, cholestyramine, or vancomycin may be used; repeat as necessary. Do NOT use antiperistaltic antidiarrheals for severe watery diarrhea. (3) Administer anticonvulsants if clinically indicated. [USP DI 20th ed. 2000] Dextrose Injection General: Dextrose Injection is non-hazardous. Wash affected area with water. SECTION 5 – TOXICOLOGICAL INFORMATION Cefuroxime Sodium Oral Rat: LD50: >10g/kg Oral Mouse: LD50: > 10g/Kg Irritancy Data: N/F Target Organ(s): N/F Listed as a Carcinogen? NTP: No Dextrose Injection N/A IARC: No OSHA: No Other: No SECTION 6 – FIRE FIGHTING MEASURES Cefuroxime Sodium Health: 1 Fire: 1 Reactivity: Extinguisher Media: 1 Special: A (Allergen) Water spray, dry chemical, carbon dioxide or foams as appropriate for surrounding fire and materials. MATERIAL SAFETY DATA SHEET (MSDS) Fire and Explosion Hazards: Page 4 of 6 This material is assumed to be combustible. As with all dry powders, it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity. Firefighting Procedures: As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing. Dextrose Injection Non flammable, non combustible SECTION 7 – PHYSICAL HAZARDS Cefuroxime Sodium Conditions to Avoid: Avoid exposure to light, heat and moisture. Incompatibilities: Oxidizing agents. Decomposition Products: When heated to decomposition material emits toxic fumes of NOx, SOx and Na2O. Emits toxic fumes under fire conditions. Stable? Yes Dextrose Injection Non-hazardous Hazardous Polymerization: No SECTION 8 – HANDLING / SPILL / DISPOSAL MEASURES Cefuroxime Sodium Handling: As a general rule, when handling Cefuroxime sodium avoid all contact and inhalation of dust. Wash thoroughly after handling. Storage: Store per label instructions to ensure product integrity. Spill Response: Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labeled container for disposal. Wash spill site with plenty of water. Disposal: Dispose of waste in accordance with all applicable Federal, State and local laws. Dextrose Injection No special handling, storage, spill response and disposal required. Drug Product Dispose of waste drug product (constituted solution) in accordance with all applicable Federal, State and local laws. MATERIAL SAFETY DATA SHEET (MSDS) Page 5 of 6 SECTION 9 – EXPOSURE CONTROLS / PERSONAL PROTECTION Cefuroxime Sodium Respiratory Protection: When working with small quantities in a well-ventilated area, respiratory protection may not be required. The use of an approved dust mask is recommended. Ventilation: No special ventilation required. Gloves: Rubber (use non-latex gloves if possible) Eye Protection: Safety Glasses. Protective Clothing: Protect exposed skin. Dextrose Injection N/A SECTION 10 – PHYSICAL AND CHEMICAL PROPERTIES Cefuroxime Sodium Appearance and Odor: White to beige powder. Melting Range: 216°C (Decomposes) Solubility in Water: Freely Soluble. Vapor Density: N/F Boiling Point: N/F Evaporation Rate: N/F Specific Gravity: N/F Reactivity in Water: N/F Vapor Pressure: N/F %Volatile by Volume: N/F Dextrose Injection N/A SECTION 11 – OTHER INFORMATION Information provided in this MSDS is intended to be used in the handling of this material in the work place. This MSDS is not a substitute for the direction for use or product literature that may accompany the finished product. All information contained in this MSDS has been assembled from other published documents and are assumed to be accurate. In the event of an adverse incident associated with this material, this MSDS is not intended to be a substitute for consultation with appropriately qualified personnel. For additional information contact: B. Braun Medical Inc. [Clinical & Technical Support Line] 1-800-854-6851 MATERIAL SAFETY DATA SHEET (MSDS) SECTION 12 - GLOSSARY CAS EINECS HMIS IARC MSDS N/A N/F NTP OSHA RTECS USP Chemical Abstract Service European Inventory of Existing Chemical Substance Hazardous Material Identification System International Agency for Research on Cancer Material Safety Data Sheet Not Applicable Not Found National Toxicology Program Occupational Safety and Health Administration Registry of Toxic Effects of Chemical Substances United States Pharmacopeia SECTION 13 - REFERENCES USP-MSDS for Cefuroxime Sodium Eli Lilly-MSDS for Cefuroxime Sodium B. Braun Medical Inc. DFU for Cefuroxime for Injection and Dextrose Injection Page 6 of 6