Azithromycin Oral Suspension Finished Product Material Safety Data Sheet

Transcription

1 SECTION 1 - IDENTIFICATION PRODUCT ME Azithromycin Oral Suspension SYNONYMS Zithromax CHEMICAL FAMILY Azalide. THERAPEUTIC CATEGORY Antibiotic. SECTION 2 HEALTH HAZARD INFORMATION EMERGENCY OVERVIEW EYE SKIN INGESTION INHALATION ADVERSE SYSTEMIC EFFECTS CHRONIC (CANCER) INFORMATION REPRODUCTION INFO MEDICAL CONDITIONS/MEDS AGGRAVATED BY EXPOSURE CAUTION The information in this MSDS is based on the hazards of the active ingredient. While diluted, this material may present the following hazards MAY CAUSE HYPERSENSITIVITY REACTIONS IN SUSCEPTIBLE INDIVIDUALS. MAY CAUSE LIVER TOXICITY. May cause eye irritation. Signs and symptoms might include redness, swelling, blurred vision or pain. May cause skin irritation. May cause allergic reactions in susceptible individuals. Dust may cause respiratory tract and mucous membrane irritation. May cause irritation. Transient diarrhea, nausea and abdominal pain. Persons sensitive to this material or other materials in its chemical class may develop allergic reactions. NTP Not listed. IARC Not listed. OSHA Not listed. FDA PREGNCY CATEGORY B. No adequate and well-controlled studies in pregnant women have been conducted. Animal studies conducted failed to demonstrate a risk to the fetus. May cause hypersensitivity reactions in susceptible individuals. Page 1 of 6

2 TARGET ORGANS Liver. APPEARANCE Powder. ODOR Odorless. SECTION 3 INGREDIENT INFORMATION COMPONENT CAS NUMBER % BY WEIGHT Azithromycin Monohydrate Silicone Dioxide Sodium Phosphate Sucrose SECTION 4 FIRST AID MEASURES EYES SKIN INGESTION INHALATION NOTE TO PHYSICIANS Flush with large quantities of water for 15 minutes. Brush off material; remove contaminated clothing, flush with large quantities of water for 15 minutes. Flush mouth with water obtain medical attention. Remove to fresh air. SECTION 5 FIRE FIGHTING MEASURES FLAMMABLE PROPERTIES HAZARDOUS COMBUSTION PRODUCTS EXTINGUISHING MEDIA Material is assumed to be combustible. Emits toxic fumes under fire conditions. Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials. Page 2 of 6

3 FIRE FIGHTING INSTRUCTION As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing. SECTION 6 ACCIDENTAL RELEASE MEASURES SPILL Wear appropriate PPE. Scoop up slowly without generating tablets and generating dust. (NO DRY SWEEPING). Wet wipe surfaces. SECTION 7 HANDLING AND STORAGE HANDLING STORAGE Keep container closed, minimize dust generation during transfer. Also for more handling information, contact EHS, see Teva Global EHS "Guidelines for Safe Handling of APIs & Drugs" or "Containment Guidelines for Handling Different Quantities of Active Ingredients". Store in tight container. SECTION 8 EXPOSURE CONTROL AND PPE ENGINEERING CONTROLS RESPIRATORY PROTECTION SKIN PROTECTION EYE PROTECTION Operations involving handling/transferring of dry power should be performed using containment measures (i.e. enclosures, etc.) and local exhaust ventilation. Wear appropriate PPE according to dust level. Wear appropriate PPE according to dust level. Wear appropriate PPE according to dust level. COMPONENT EXPOSURE LIMIT Azithromycin monohydrate PIEL 80 µg/m 3 Silicone Dioxide Sodium Phosphate Sucrose Page 3 of 6

4 SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES BOILING POINT No information found. MELTING POINT No information found. ph No information found. VAPOR PRESSURE VAPOR DENSITY SOLUBILITY IN WATER ODOR Odorless. APPEARANCE Powder. SPECIFIC GRAVITY AUTOIGNITION TEMPERATURE FLAMMABLE LIMITS MOLECULAR WEIGHT FLASHPOINT OCTANOL/WATER COEFFICIENT EVAPORATION RATE SECTION 10 STABILITY AND REACTIVITY CHEMICAL STABILITY (CONDITIONS TO AVOID) INCOMPATIBILITY HAZARDOUS DECOMPOSITION PRODUCTS HAZARDOUS POLYMERIZATION This material is considered stable from a safety point of view. Strong oxidizers. When heated to decomposition, material emits toxic fumes. Will not occur. Page 4 of 6

5 SECTION 11 TOXICOLOGICAL INFORMATION EYE SKIN INGESTION INHALATION ACUTE/SUBCHRONIC LD 50 oral LD50 (male rat) = 3000 mg/kg. oral LD50 (female rat) = 4000 mg/kg. oral LD50 (male mouse) > 200 mg/kg. oral LD50 (female mouse) > 2000 mg/kg. Subchronic toxicity of azithromycin was evaluated in rats at oral (gavage) doses up to 10 mg/kg/day for 6 months. No adverse effects on food consumption or body weight gain were observed. There was no histological evidence of phospholipidosis or any other drug induced changes. Sporadic mild hepatic enzyme elevations were observed during and after cessation of dosing. Subchronic toxicity was also evaluated in dogs at oral (gavage) doses up to 40 mg/kg/day for 6 months. Findings were similar to those found in rats except for the presence of the phospholipidosis. MUTAGENICITY/ CARCINOGENICITY REPRODUCTION No evidence of mutagenicity was observed for azithromycin or its metabolites in vivo or in vitro in the following assays: Ames test, mouse lymphoma L5178Y, and chromosal aberration assay in human lymphocytes. Decreased pregnancy rates were observed in reproductive and fertility studies in rats at oral (gavage) doses up to 20 mg/kg/day. No other drug related effects were noted in dams or progeny. SECTION 12 ECOLOGICAL INFORMATION ECOTOXICOLOGICAL INFORMATION The use and/or disposal of this material, it s metabolites or degradation products is not expected to cause adverse effects upon animals, plants, humans, other organisms, or the environment. Page 5 of 6

6 CHEMICAL FATE INFORMATION SECTION 13 DISPOSAL CONSIDERATIONS Dispose of in accordance with all applicable federal, state, and local regulations. SECTION 14 TRANSPORTATION INFORMATION Finished products in final packaging ready for consumer use are NOT regulated by DOT. SECTION 15 REGULATORY INFORMATION OSHA CERCLA SECTION 313 (SARA TITLE III) OTHER REGULATIONS SECTION 16 OTHER INFORMATION PREPARED BY REVISIONS Rob McCafferty & Nevada Venhorst New MSDS. DISCLAIMER: Teva Pharmaceuticals, Inc. provides the information contained in this MSDS sheet in good faith but makes no claim as to its accuracy or Comprehensiveness. This MSDS sheet is intended as a guide for a properly trained person to utilize appropriate precautionary methods while handling this product. Individuals must exercise their own judgment in determining the appropriateness of this information for a particular purpose. All MSDS sheets are subject to revision from time-to-time as new information becomes available. Anyone proposing to rely on information regarding the substance that is the subject of this MSDS sheet is responsible for ensuring that he or she has obtained and reviewed the most recent version of the sheet available at the time. Teva Pharmaceuticals, Inc. will not be responsible for damages resulting from the use or misuse of the information contained in this MSDS sheet. Page 6 of 6