Microsoft word - citalopram hydrobromide oral solution.doc
Page 1 of 3 – Citalopram Hydrobromide Oral Solution 2 mg/mL IN CASE OF EMERGENCY Emergency Phone: (614) 276-4000 Material Safety Data Sheet 1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION Common/Trade Name: Citalopram Hydrobromide Oral Solution 10 mg/ 5 mL Chemical Name: 1-(3-dimethylaminopropyl)-1-(p-fluoropheny)-5-phthalancarbonitrile hydrobromide Synonyms: None Molecular Formula: C20H22BrFN2O Molecular Weight: 405.35 CAS No: 59729-32-7 Chemical Family: Selective serotonin reuptake inhibitor (SSRI) Product Use: Antidepressant Manufacturer’s Name: Boehringer Ingelheim Roxane Inc. Address: 1809 Wilson Road Columbus, Ohio 43228 2. COMPOSITION / INFORMATION ON INGREDIENTS Composition CAS# Exposure Citalopram Hydrobromide (active ingredient) 59729-32-7 established REFER to PHYSICIAN’S DESK REFERENCE for common components present as <1% 3. HAZARDS IDENTIFICATION Emergency Physical State: Liquid solution administered orally. Overview Peppermint flavored oral solution with 10 mg/5 mL active ingredient. Odor: None WARNING! May be harmful if swallowed. Accidental ingestion of large amounts may be fatal. Primary Route(s) Ingestion Potential Health Inhalation: Not expected to be an inhalation hazard in final pharmaceutical form. Effects: Eye Contact: Not expected to be a hazard to the eye. Contact with eye may cause irritation, burning and redness. Skin Contact: Not expected to be a hazard to the skin. Can cause hypersensitive reactions resulting in rash, redness, itching and inflammation. Ingestion: May be harmful if ingested. Ingestion may cause headache, nausea, dizziness, fatigue, and fast heartbeat. Toxicity Data: See Section 11 Effects of The potential for exposure is reduced in finished pharmaceutical form. Overexposure: Overexposure by ingestion may cause nausea, headache, oedema and heart palpitations. Target Organs: Brain, Central Nervous System 4. FIRST AID MEASURES Eye Exposure Any material that contacts the eye should be washed out immediately with water. If easy to do, remove contact lenses if worn. Get medical attention if symptoms persist. Skin Exposure Wash with soap and water. Get medical attention if symptoms occur. Page 2 of 3 – Citalopram Hydrobromide Oral Solution 2 mg/mL Ingestion Call a physician or poison control center immediately. Inhalation Should not pose a hazard in the final form. If breathing is difficult, move to fresh air. Get medical attention immediately. 5. FIRE AND EXPLOSION HAZARDS Flammability Lower: N/A Upper: N/A Flash Point Not available Extinguishing Media Use water spray, carbon dioxide, dry chemical, foam or material appropriate for fire in surrounding area. Special Fire Fighting Procedures Wear full protective clothing and self-contained breathing apparatus. Unusual Fire/Explosion Not Applicable Hazardous Combustion Products Carbon dioxide, carbon monoxide, oxides of nitrogen, hydrogen bromide, hydrogen fluoride 6. ACCIDENTAL RELEASE INFORMATION STEPS TO BE TAKEN IF SIGNIFICANT QUANTITIES OF LIQUID IS SPILLED: Use appropriate personal protective equipment (see Section 8). Wipe up and containerize spill material in a compatible container. Dispose according to applicable regulations. Incineration of the waste at an approved facility is recommended. 7. PRECAUTIONS FOR SAFE HANDLING AND USE Precautions Handling Observe good industrial hygiene practices. Significant Quantities of Liquid: Storage Store at 20° to 25°C (68° to 77°F). Keep container closed tightly. Protect from light and moisture. Store away from foodstuffs. 8. CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT Exposure Limits Engineering Controls Not required when handling liquid or containers. Good ventilation should be used. Ventilation should be matched to conditions. Respiratory Not required when handling liquid or containers. NIOSH/MSHA approved respirators for Protection protection should be used if respirators are found to be necessary. Ventilation should be matched to conditions. Personal Protection Not required when handling final product. If containers are compromised or exposure is likely wear: Goggles, Lab Coat, Gloves Recommended Facilities Eye wash, washing facilities 9. PHYSICAL / CHEMICAL CHARACTERISTICS Appearance Oral solution Not available Solubility in Boiling point Not available Specific Gravity Not available Taste Peppermint Pressure available Flashpoint available available Not available Flammability Not available 10. STABILITY AND REACTIVITY DATA Stability Stable Incompatibility None Hazardous Decomposition Oxides of carbon, oxides of nitrogen, hydrogen bromide, hydrogen fluoride Conditions to Excessive heat and light Page 3 of 3 – Citalopram Hydrobromide Oral Solution 2 mg/mL Hazardous Polymerization Will not occur. 11. TOXICOLOGICAL INFORMATION Acute Toxicity: Active Ingredient: LD50 Oral (rat): approximately 800 mg/kg Carcinogenicity: Not listed as a carcinogen by NTP, IARC Monographs or OSHA. 12. ENVIRONMENTAL IMPACT INFORMATION No information is currently available on the environmental impact of this product. 13. DISPOSAL INFORMATION Waste Disposal Considerations: Dispose of material according to federal, state and local disposal regulations or company operating procedures. Disposal by incineration is recommended. At home: Discard away from children’s reach. 14. TRANSPORTATION INFORMATION This product is not subject to the regulations for the safe transport of hazardous chemicals. DOT: Not regulated TDG: Not regulated IATA: Not regulated IMDG: Not regulated 15. REGULATORY INFORMATION DEA: Citalopram Hydrobromide is not a controlled substance. FDA: Citalopram Hydrobromide is an approved prescription medication. Inventory Status: This material is not listed on the US TSCA Inventory. Therefore, it can only be used for TSCA exempt purposes such as R&D or drug use. This material is not listed on the DSL Inventory but is exempt. 16. OTHER DATA ABBEVIATIONS: N/A – not applicable Prepared by: Boehringer Ingelheim Roxane Inc. References: 1. Citalopram Hydrobromide Oral Solution, Package Insert, Boehringer Ingelheim Roxane Inc., Columbus, Ohio 2. RTECS No. NP6406750 for 5-Isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3- dihydro-,monohydrobromide 3. Ariel Webinsight. Regulatory and ChemExpert Database. 4. PDR – Physicians Desk Reference Date: 09/13/2008 - New MSDS SEE CURRENT PACKAGE INSERT FOR FURTHER INFORMATION The information provided is believed to be complete and accurate. If this product is combined with other materials, deteriorates or becomes contaminated, it may pose hazards not mentioned in this MSDS. It is the users’ responsibility to use the information according to the application. Boehringer Ingelheim Roxane Inc.assumes no responsibility or liability resulting from the use of this information.
Julia Hughes HNC/D Animal Studies Module: Microbiology Microbiology: Practical Competence Introduction Infectious diseases in animals are caused by the invasion of tissues by bacteria, especially the epithelium, by microorganisms. This invasion have many effects which can be detrimental to the animals health, let alone be passed on to other animals through physical contact,
God and Evolution Murtada Mutahhari's The Causes Responsible for Materialist tendencies in the West Translated from the Persian by Mujahid Husayn Among the various issues which in my opinion have had a great impact on materialistic tendencies is the false notion that there is a contradiction between the principle of creation on the one hand and the theory of evolution, especially the
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