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300 Northfield Road Bedford, OH 44146 MATERIAL SAFETY DATA SHEET Telephone: (440) 232-3320 -or- (800) 562-4797 Section I - IDENTITY Common/Trade Name: Fluphenazine Decanoate Injection (5ml/vial) Chemical Names: Fluphenazine Decanoate Synonyms: Prolixin Decanoate®, Dapotum D, Lyogen, Modecate, Moditen depot Manufacturer's Name: BEN VENUE LABORATORIES, INC. Address: 300 NORTHFIELD ROAD BEDFORD, OH 44146 Emergency Telephone Number: Chemtrec: 1(800)424-9300 Telephone Number for Info.: (440)232-3320 or (800)562-4797 Medical Emergency: Professional Services 1(800)521-5169 Date Prepared: August 31, 1995 Date Revised: December 18, 2001 Date Revised: July 13, 2007 Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION Other Limits Component % CAS# OSHA PEL ACGIH TLV Recommended Fluphenazine 2.5% 5002-47-1 NONE NONE 0.002mg/m3 Decanoate (as determined by Bristol Myers Squibb) Sesame Oil 96.3% 8008-74-0 NONE NONE NONE Benzyl Alcohol 1.2% 100-51-6 NONE NONE NONE Fluphenazine Decanoate is a sterile injectable organic liquid drug provided in a vial. Section III - HEALTH HAZARD DATA Routes of Entry: Fluphenazine Decanoate is rapidly absorbed via oral route. It is not considered to present an inhalation hazard during normal use. Health Hazard (Acute & Chronic): Fluphenazine Decanoate is an antipsychotic drug used in treating mental disorders such as schizophrenia. Acute effects of exposure may be an allergic reaction in persons sensitive to Fluphenazine and/or other phenothiazines and contact dermatitis. Other affects if ingested may include sedation, hypotension, nausea, vomiting, neuromuscular reactions and dry mouth. Chronic effects are not yet known. Carcinogenicity: NTP? NO IARC Monographs? NONE OSHA Regulated? NO Signs & Symptoms of Exposure: Effect of exposure includes sedation, hypotension, nausea, headache, restlessness, dry mouth, redness and itching of skin. Medical Conditions Generally Aggravated by Exposure: Therapeutic doses may aggravate convulsive disorders, liver damage, blood dyscrasias, allergies to other phenothiazines. BVL Hazard Category: 3 Section IV - FIRST AID MEASURES Eye Exposure: Flush eyes with large volumes of water for 15 minutes. Skin Exposure: Wash skin with cool soapy water for 15 minutes. Ingestion: If ingestion occurs, seek medical attention from a physician immediately. Induce vomiting if possible. Never induce vomiting on an unconscious person. Inhalation: If difficulty breathing, administer oxygen. Seek attention of a physician immediately. If necessary, provide artificial respiration. Section V - FIRE AND EXPLOSION HAZARD DATA Flash Point (Method Used): Not available LEL: Not available UEL: Not available Flammable Limits: Not available Extinguishing Media: Use foam or a type ABC multi-purpose extinguisher. Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Firefighters should wear self-contained breathing apparatus to avoid inhalation of smoke. Unusual Fire/Explosion Hazards: None Section VI - ACCIDENTAL RELEASE INFORMATION Release to land: Absorb Fluphenazine Decanoate with absorbent materials and dispose of according to local, state, and federal guidelines. Release to air: If aerosolized, reduce exposures by ventilating the area; clean up spill immediately to prevent evaporation. Release to water: Refer to local water authority. Drain disposal is not recommended; however, refer to local, state, and federal disposal guidelines. Section VII - PRECAUTIONS FOR SAFE HANDLING AND USE Steps to be taken in case material is released or spilled: See Section VI above. Wear latex or nitrile glove and safety glasses when cleaning spills. A half mask respirator with organic vapor cartridges may be necessary if excessive aerosolization occurs. Waste Disposal Method: Incineration in an approved incinerator is recommended. Refer to local, state, and federal rules. Precautions to be taken in handling and storing: Store at controlled room temperature; avoid freezing and excessive heat. Protect from light. Other Precautions: None Section VIII - CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT Respiratory Protection: Under normal use, respirators are not required If aerosols are generated, an air-purifying respirator with organic vapor cartridges may be needed. Personnel wearing respirators should be fit tested and approved for respirator use under the OSHA Respiratory Protection Standard CFR 1910.134. Ventilation: Handle product in a well-ventilated area. Protective Gloves: Nitrile or latex Eye Protection: Safety glasses Other Protective Clothing or Equipment: Lab Coat Work/Hygienic Practices: Wash hands following use. No eating, drinking, or smoking while handling product. Section IX - PHYSICAL/CHEMICAL CHARACTERISTICS Physical State: Liquid Specific Gravity: Not available Appearance and Odor: Clear, light yellow oily liquid with little or no perceivable odor Melting Point: Not applicable Boiling Point: Not available Evaporation Rate: Not available Vapor Pressure: Not available Solubility in Water: Insoluble Vapor Density: Not available pH: Not available Section X - STABILITY AND REACTIVITY DATA Stability: Stable at normal room temperature Incompatibility (Materials to Avoid): None known Hazardous Decomposition or Byproducts: Thermal decomposition or burning may produce noxious byproducts such as carbon monoxide, carbon dioxide, hydrogen fluoride, and nitrogen and sulfur oxides. Hazardous Polymerization: Will not occur Conditions to Avoid: Protect from light Section XI - TOXICOLOGICAL INFORMATION For Fluphenazine Decanoate: RTECS # HE0525000 LD50 oral, rat = 19 mg/kg LD50 intramuscular, rat = 576 mg/kg LD50 intramuscular, mouse = 60 mg/kg LD50 intramuscular, dog = > 1500 mg/kg Additional reproductive health data is available from the National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS). 3 Section XII - ENVIRONMENTAL IMPACT INFORMATION Information is currently not available on the environmental impact of Fluphenazine Decanoate. Handle in a manner to prevent spills or releases to the environment. Section XIII - DISPOSAL INFORMATION Dispose of by incineration at an approved/permitted incinerator. Review local, state, and federal regulations for your regulatory area. Section XIV - TRANSPORTATION INFORMATION Fluphenazine Decanoate Injection is not a DOT Hazardous Material. Fluphenazine Decanoate Injection is not a Marine Pollutant Section XV - REGULATORY INFORMATION SARA 313 listed?: NO CERCLA listed?: NO RCRA listed?: NO Section XVI - OTHER DATA 1. Use of this product should be through or under the direction of a physician. This MSDS does not address therapeutic use of this material. 2. Persons administering this drug to patients must be careful to avoid needle sticks to syringes and other sharps used in the administration. All needle sticks must be reported to your company management. 3. BVL Hazard Category Definitions (internal hazard ranking used by Ben Venue Laboratories): 1 = Low Toxicity 2= Moderate Toxicity 3 = Potent or Toxic 4 = Highly Potent or Toxic 5 = Extremely Potent or Toxic 4. OEL=Occupational Exposure Limit. An internal limit set by Ben Venue Laboratories for the recommended limit of employee exposure to airborne dusts or aerosols that should not be exceeded over an eight-hour time-weighted average. 5. Fluphenazine Decanoate may be considered a Hazardous Drug as described in the NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. Employees who prepare or administer hazardous drugs or who work in areas where these drugs are used should follow specific handling guidelines in order to prevent exposure to these agents in the air or on work surfaces, clothing, or equipment. 4 5 6. The Following Guidance Information is excerpted from the NIOSH Alert: Elements of a Hazardous Drug Handling Program include: • Establishment and implementation of written policies and protocols to ensure the safe handling of oncolytic and/or potent drugs, including receipt of product. • Training and education of employees on the recognition, evaluation and control of Hazardous Drugs • Effective Planning and design of the workplace • Use of best practice control measures and specialized equipment such as ventilated cabinets or isolators designed for worker protection • Wearing recommended personal protective equipment • An integrated health surveillance program that: includes the assessment and counseling of prospective employees before they commence any work involving oncolytic and/or potent drugs and related waste 7. Published guidance on the handling and transport of cytotoxic drugs: NIOSH Alert – Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings http://www.cdc.gov/niosh/docs/2004-165/ National Study Commission on Cytotoxic Exposure: Recommendation for handling Cytotoxic Agents: http://www.nih.gov/od/ors/ds/pubs/cyto/index.htm This document is generated to distribute health, safety and environmental data. It is not a specification sheet and none of the displayed data should be construed as a specification. Information on this MSDS sheet was obtained from sources which we believe are reliable, and we believe that the information is complete and accurate. However, the information is provided without any warranty, express or implied, regarding its correctness. Some of the information presented and conclusions drawn are from sources other than direct test data of the substance. The conditions or methods of handling, storage, use and disposal of the product are beyond our control and may also be beyond our knowledge. It is the user’s responsibility to determine the suitability of any material for a specific purpose and to adopt such safety precautions as may be necessary. If the product is used as a component in another product, this MSDS information may not be applicable. For these reasons, we do not assume any responsibility and expressly disclaim liability for any loss, damage or expense arising out of or in any way connected with the handling, storage, use or disposal of this product
