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    CABERGOLINE Safety2

    Uploaded by

    Kane Smith
    This document provides a material safety data sheet for cabergoline tablets, which are used as a pharmaceutical product for lactation inhibition. The active ingredient, cabergoline, is listed as an ingredient that may be harmful if swallowed based on animal data. Exposure to the crushed or broken tablets could cause effects similar to those seen in clinical use, such as nausea, vomiting or diarrhea. Personal protective equipment is recommended when handling large quantities of the product. The document also includes information on toxicology of cabergoline, such as acute toxicity testing on animals and genetic toxicity testing showing it is not carcinogenic or mutagenic.

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    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd

    CABERGOLINE Safety2

    Uploaded by

    Kane Smith
    17K views6 pages
    This document provides a material safety data sheet for cabergoline tablets, which are used as a pharmaceutical product for lactation inhibition. The active ingredient, cabergoline, is listed as an ingredient that may be harmful if swallowed based on animal data. Exposure to the crushed or broken tablets could cause effects similar to those seen in clinical use, such as nausea, vomiting or diarrhea. Personal protective equipment is recommended when handling large quantities of the product. The document also includes information on toxicology of cabergoline, such as acute toxicity testing on animals and genetic toxicity testing showing it is not carcinogenic or mutagenic.

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    CABERGOLINE safety2

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    This document provides a material safety data sheet for cabergoline tablets, which are used as a pharmaceutical product for lactation inhibition. The active ingredient, cabergoline, is listed as an ingredient that may be harmful if swallowed based on animal data. Exposure to the crushed or broken tablets could cause effects similar to those seen in clinical use, such as nausea, vomiting or diarrhea. Personal protective equipment is recommended when handling large quantities of the product. The document also includes information on toxicology of cabergoline, such as acute toxicity testing on animals and genetic toxicity testing showing it is not carcinogenic or mutagenic.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    17K views6 pages

    CABERGOLINE Safety2

    Uploaded by

    Kane Smith
    This document provides a material safety data sheet for cabergoline tablets, which are used as a pharmaceutical product for lactation inhibition. The active ingredient, cabergoline, is listed as an ingredient that may be harmful if swallowed based on animal data. Exposure to the crushed or broken tablets could cause effects similar to those seen in clinical use, such as nausea, vomiting or diarrhea. Personal protective equipment is recommended when handling large quantities of the product. The document also includes information on toxicology of cabergoline, such as acute toxicity testing on animals and genetic toxicity testing showing it is not carcinogenic or mutagenic.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    The document provides a material safety data sheet for Cabergoline tablets, which contain the active ingredient Cabergoline. It details the composition, hazards, first aid measures, fire fighting procedures, and disposal considerations for the drug.

    The active ingredient in Cabergoline tablets is Cabergoline.

    Potential side effects from ingesting the drug include nausea, vomiting, abdominal cramps, anorexia, diarrhea, and constipation.

    MATERIAL SAFETY DATA SHEET

    Revision date: 18-Sep-2008 Version: 1.3 Page 1 of 6

    1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING


    Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222 Emergency telephone number: CHEMTREC (24 hours): 1-800-424-9300 pfizer-MSDS@pfizer.com Contact E-Mail: Pfizer Ltd Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom +00 44 (0)1304 616161 Emergency telephone number: ChemSafe (24 hours): +44 (0)208 762 8322

    Material Name: Cabergoline Tablets


    Trade Name: Chemical Family: Intended Use: DOSTINEX; CABASER Mixture Pharmaceutical product used for lactation inhibition

    2. HAZARDS IDENTIFICATION
    Appearance: Statement of Hazard: Additional Hazard Information: Short Term: Known Clinical Effects: White tablets Non-hazardous in accordance with international standards for workplace safety.

    EU Indication of danger:

    Active ingredient may be harmful if swallowed. (based on animal data) . Accidental ingestion may cause effects similar to those seen in clinical use. Ingestion of this material may cause effects similar to those seen in clinical use including nausea, vomiting, abdominal cramps, anorexia, diarrhea, and constipation. This drug may decrease the quantity/quality of breast milk. Not classified

    Australian Hazard Classification (NOHSC): Note:

    Non-Hazardous Substance. Non-Dangerous Goods.

    This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.

    _______________________________________________________________________________________________________ CABERGOLINE TABLETS

    MATERIAL SAFETY DATA SHEET


    Material Name: Cabergoline Tablets Page 2 of 6 Revision date: 18-Sep-2008 Version: 1.3 _______________________________________________________________________________________________________

    3. COMPOSITION/INFORMATION ON INGREDIENTS
    Hazardous Ingredient Cabergoline CAS Number 81409-90-7 EU EINECS/ELINCS List Not listed Classification Xn;R22 % 1.25

    Ingredient Leucine Lactose NF, anhydrous Additional Information:

    CAS Number 61-90-5 63-42-3

    EU EINECS/ELINCS List 200-522-0 200-559-2

    Classification Not Listed Not Listed

    % * *

    * Proprietary Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety.

    For the full text of the R phrases mentioned in this Section, see Section 16

    4. FIRST AID MEASURES


    Eye Contact: Skin Contact: Ingestion: Inhalation: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately. Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention. Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately. Remove to fresh air and keep patient at rest. Seek medical attention immediately.

    Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - Hazards Identification and/or Section 11 - Toxicological Information.

    5. FIRE FIGHTING MEASURES


    Extinguishing Media: Hazardous Combustion Products: Fire Fighting Procedures: Fire / Explosion Hazards: Use carbon dioxide, dry chemical, or water spray. Formation of toxic gases is possible during heating or fire. During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus. Not applicable

    6. ACCIDENTAL RELEASE MEASURES


    Health and Safety Precautions: Measures for Cleaning / Collecting: Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. Contain the source of spill if it is safe to do so. Collect spilled material by a method that controls dust generation. A damp cloth or a filtered vacuum should be used to clean spills of dry solids. Clean spill area thoroughly. Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.

    Measures for Environmental Protections:

    _______________________________________________________________________________________________________ CABERGOLINE TABLETS

    MATERIAL SAFETY DATA SHEET


    Material Name: Cabergoline Tablets Page 3 of 6 Revision date: 18-Sep-2008 Version: 1.3 _______________________________________________________________________________________________________ Additional Consideration for Large Spills: Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel.

    7. HANDLING AND STORAGE


    General Handling: Restrict access to work area. If tablets or capsules are crushed and/or broken, avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Wash thoroughly after handling. Releases to the environment should be avoided. Review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dust collectors, HEPA filtration systems or other equivalent controls. Store as directed by product packaging.

    Storage Conditions:

    8. EXPOSURE CONTROLS / PERSONAL PROTECTION


    Leucine Latvia OEL - TWA

    Listed

    Cabergoline Pfizer Occupational Exposure OEB5 (control exposure to <1ug/m3) Band (OEB): Engineering Controls: Environmental Exposure Controls: Personal Protective Equipment: Engineering controls should be used as the primary means to control exposures. Refer to specific Member State legislation for requirements under Community environmental legislation. Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE). Not required for the normal use of this product. Wear protective gloves when working with large quantities. Not required for the normal use of this product. Wear safety glasses or goggles if eye contact is possible. Not required for the normal use of this product. Wear protective clothing when working with large quantities. Not required for the normal use of this product. Whenever excessive air contamination (dust, mist, vapor) is generated, respiratory protection, with appropriate protection factors, should be used to minimize exposure.

    Hands: Eyes: Skin: Respiratory protection:

    9. PHYSICAL AND CHEMICAL PROPERTIES:


    Physical State: Molecular Formula: Tablets Mixture Color: Molecular Weight: White Mixture

    10. STABILITY AND REACTIVITY


    Stability: Conditions to Avoid: Incompatible Materials: Hazardous Decomposition Products: Stable at normal conditions None known As a precautionary measure, keep away from strong oxidizers Nitrogen oxides (nox) Carbon oxides

    _______________________________________________________________________________________________________ CABERGOLINE TABLETS

    MATERIAL SAFETY DATA SHEET


    Material Name: Cabergoline Tablets Page 4 of 6 Revision date: 18-Sep-2008 Version: 1.3 _______________________________________________________________________________________________________

    11. TOXICOLOGICAL INFORMATION


    General Information: The information included in this section describes the potential hazards of the active ingredient(s).

    Acute Toxicity: (Species, Route, End Point, Dose) Cabergoline Rat Oral LD 50 383 (F) mg/kg Rat Intravenous LD 50 22mg/kg Mouse Oral LD 50 202 (F)mg/kg Mouse Intravenous LD 50 24 (F)mg/kg Irritation / Sensitization: (Study Type, Species, Severity) Cabergoline Skin Sensitization - GPMT

    Guinea Pig

    No effect

    Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s)) Cabergoline Embryo / Fetal Development Embryo / Fetal Development Embryo / Fetal Development

    Rat Oral0.012 mg/kg/day Rabbit Oral 8 mg/kg/day Mouse Oral 8 mg/kg/day

    LOAEL Fetotoxicity NOAEL Not Teratogenic Not Teratogenic, Maternal Toxicity

    Genetic Toxicity: (Study Type, Cell Type/Organism, Result) Cabergoline In Vitro Mammalian Cell Mutagenicity Hamster Negative In Vitro Chromosome Aberration Human Lymphocytes Negative In Vitro Micronucleus Mouse Bone Marrow Negative In Vitro Direct DNA Damage Bacteria Negative Bacterial Mutagenicity (Ames) Salmonella Negative Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Cabergoline 24 Month(s) Rat Oral 0.320 mg/kg/day Not carcinogenic 21 Month(s) Mouse Oral 0.980 mg/kg/day Not carcinogenic Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.

    12. ECOLOGICAL INFORMATION


    Environmental Overview: Environmental properties have not been investigated. Releases to the environment should be avoided.

    _______________________________________________________________________________________________________ CABERGOLINE TABLETS

    MATERIAL SAFETY DATA SHEET


    Page 5 of 6 Material Name: Cabergoline Tablets Revision date: 18-Sep-2008 Version: 1.3 _______________________________________________________________________________________________________

    12. ECOLOGICAL INFORMATION

    13. DISPOSAL CONSIDERATIONS


    Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater.

    14. TRANSPORT INFORMATION


    Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.

    15. REGULATORY INFORMATION


    EU Indication of danger: Not classified

    OSHA Label: Non-hazardous in accordance with international standards for workplace safety.

    Canada - WHMIS: Classifications WHMIS hazard class: None required This product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the information required by the CPR.

    Cabergoline Standard for the Uniform Scheduling for Drugs and Poisons: Leucine Inventory - United States TSCA - Sect. 8(b) Australia (AICS): EU EINECS/ELINCS List Lactose NF, anhydrous Inventory - United States TSCA - Sect. 8(b) Australia (AICS): EU EINECS/ELINCS List

    Schedule 4

    Present Present 200-522-0

    Present Present 200-559-2

    _______________________________________________________________________________________________________ CABERGOLINE TABLETS

    MATERIAL SAFETY DATA SHEET


    Material Name: Cabergoline Tablets Page 6 of 6 Revision date: 18-Sep-2008 Version: 1.3 _______________________________________________________________________________________________________

    15. REGULATORY INFORMATION

    16. OTHER INFORMATION


    Text of R phrases mentioned in Section 3 R22 - Harmful if swallowed. Data Sources: Reasons for Revision: Pfizer proprietary drug development information. Publicly available toxicity information. Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information on Ingredients. Updated Section 4 - First Aid Measures. Updated Section 7 - Handling and Storage. Updated Section 8 - Exposure Controls / Personal Protection. Updated Section 13 Disposal Considerations.

    Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known information at this time. End of Safety Data Sheet

    _______________________________________________________________________________________________________ CABERGOLINE TABLETS

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