Alprostadil Injection Msds

MATERIAL SAFETY DATA SHEET
Revision date: 05-Nov-2009 Page 1 of 8
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 [email protected] 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: Alprostadil Concentrate for Solution for Infusion

Trade Name: Chemical Family: Intended Use: Prostin VR Pediatric Sterile Solution; Prostivas Mixture Indicated to temporarily maintain the patency of the ductus arteriosus until surgery can be performjed in neonates who have congenital heart defects and who depend upon the patent ductus for survival.
2. HAZARDS IDENTIFICATION
Appearance: Signal Word: Statement of Hazard: Additional Hazard Information: Short Term: Clear liquid DANGER Highly flammable liquid and vapor.
Long Term:
Known Clinical Effects:
EU Indication of danger: EU Hazard Symbols:
May cause eye and skin irritation. May be harmful if absorbed through the skin. May be harmful if swallowed. Harmful if inhaled . Exposure to high concentrations may cause irritation, headache, drowsiness, and symptoms of alcohol intoxication. Repeat-dose studies in animals have shown a potential to cause adverse effects on reproductive system, the developing fetus. This product contains ethanol which can cause liver changes, central nervous system effects, and birth defects in the developing fetus Clinical use of this drug has caused symptoms of asthma, vomiting, diarrhea, increased bleeding time, clotting abnormalities, flushing, decrease in blood pressure (hypotension), decreased heart rate (bradycardia). Stimulates smooth muscle contraction. F - Highly flammable
EU Risk Phrases: Australian Hazard Classification (NOHSC): R11 - Highly flammable. Hazardous Substance. Dangerous Goods.
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Material Name: Alprostadil Concentrate for Solution for Infusion Revision date: 05-Nov-2009 Page 2 of 8
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2. HAZARDS IDENTIFICATION
Note: 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.
3. COMPOSITION/INFORMATION ON INGREDIENTS
Hazardous Ingredient Ethanol Alprostadil Additional Information: CAS Number 64-17-5 745-65-3 EU EINECS/ELINCS List 200-578-6 212-017-2 Classification F;R11 Xn;R22 % 99.95 0.05
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. Carbon dioxide, carbon monoxide During all fire fighting activities, wear appropriate protective equipment, including selfcontained breathing apparatus. Flammable liquid and vapor. Vapors are heavier than air and may travel along surfaces to remote ignition sources and flash back.
6. ACCIDENTAL RELEASE MEASURES

Health and Safety Precautions: Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure. Eliminate all sources of ignition and ventilate area using explosion-proof equipment.

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Measures for Cleaning / Collecting: Measures for Environmental Protections: Additional Consideration for Large Spills:
Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill area thoroughly. Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release. 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: Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist. Wash thoroughly after handling. Use with adequate ventilation. Keep away from heat, sparks, flame and all other sources of ignition. Store as directed by product packaging.
Storage Conditions:
8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Refer to available public information for specific member state Occupational Exposure Limits. Ethanol ACGIH Threshold Limit Value (TWA) ACGIH OELs - Notice of Intended Changes Australia TWA Austria OEL - MAKs Belgium OEL - TWA Bulgaria OEL - TWA Czech Republic OEL - TWA Denmark OEL - TWA Estonia OEL - TWA Finland OEL - TWA France OEL - TWA Germany - TRGS 900 - TWAs Germany (DFG) - MAK Greece OEL - TWA Hungary OEL - TWA Ireland OEL - TWAs Latvia OEL - TWA Lithuania OEL - TWA OSHA - Final PELS - TWAs: Poland OEL - TWA Portugal OEL - TWA Romania OEL - TWA Slovenia OEL - TWA Spain OEL - TWA Sweden OEL - TWAs Alprostadil Pfizer OEL TWA-8 Hr:
1000 ppm TWA Listed 1000 ppm 1880 mg/m3 Listed Listed Listed Listed Listed Listed Listed Listed 500 ppm 960 mg/m3 500 ppm MAK 960 mg/m3 MAK Listed Listed Listed Listed Listed 1000 ppm 1900 mg/m3 Listed Listed Listed Listed Listed Listed
0.5 g/m3

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8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Analytical Method: Engineering Controls: Analytical method available for Alprostadil. Contact Pfizer Inc for further information. Engineering controls should be used as the primary means to control exposures. General room ventilation is adequate unless the process generates dust, mist or fumes. Keep airborne contamination levels below the exposure limits listed above in this section. 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). Wear impervious gloves if skin contact is possible. Wear safety glasses or goggles if eye contact is possible. Wear protective clothing when working with large quantities. If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL.
Environmental Exposure Controls: Personal Protective Equipment:
Hands: Eyes: Skin: Respiratory protection:
9. PHYSICAL AND CHEMICAL PROPERTIES

Physical State: Odor: Molecular Weight: Solvent Solubility: Liquid Alcohol like Mixture Soluble: Alcohols Color: Molecular Formula: Clear Mixture
Flammablity: Flash Point (Liquid) (C): Upper Explosive Limits (Liquid) (% by Vol.): Lower Explosive Limits (Liquid) (% by Vol.):
12.8 Closed cup (Ethanol) 19 3.3
10. STABILITY AND REACTIVITY

Stability: Conditions to Avoid: Incompatible Materials: Stable under normal conditions of use. Keep away from heat, spark, flames and all other sources of ignition. Reacts violently with peroxides. Acids, Acid chlorides, Acid anhydrides, Alkali metals, Ammonia, Strong oxidising agents. Hazardous Decomposition Products: Thermal decomposition products may include carbon monoxide and carbon dioxide
11. TOXICOLOGICAL INFORMATION

General Information: The information included in this section describes the potential hazards of the individual ingredients.
Acute Toxicity: (Species, Route, End Point, Dose) Alprostadil Rat Oral LD 50 228 mg/kg Rat Intravenous LD 50 19.2 mg/kg Rat Intraperitoneal LD 50 24.9 mg/kg Mouse Oral LD 50 186 mg/kg _______________________________________________________________________________________________________ ALPROSTADIL INJECTION

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11. TOXICOLOGICAL INFORMATION

Mouse Intravenous LD 50 21 mg/kg Ethanol Mouse Oral LD50 3,450 g/m3 Rat Oral LD50 7,060 mg/kg Mouse Inhalation LC50 4h 39 g/m3 Rat Inhalation LC50 10h 20,000 ppm Irritation / Sensitization: (Study Type, Species, Severity) Ethanol Eye Irritation
Rabbit
Severe
Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s)) Alprostadil Not specified
Rat
Oral 1 mg/kg/day
Maternal toxicity, Reproductive toxicity
Genetic Toxicity: (Study Type, Cell Type/Organism, Result) Alprostadil Bacterial Mutagenicity (Ames) Unscheduled DNA Synthesis Mammalian Cell Mutagenicity Carcinogen Status: Ethanol IARC: NTP: OSHA:
Salmonella Negative Negative HGPRT Negative None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.
Group 1 Listed Present
12. ECOLOGICAL INFORMATION

Environmental Overview: Environmental properties have not been investigated. Releases to the environment should be avoided.
Aquatic Toxicity: (Species, Method, End Point, Duration, Result) Ethanol Fingerling Trout NPDES LC50 24 Hours Rainbow Trout NPDES LC50 96 Hours Fathead minnow NPDES LC50 96 Hours
11,200 mg/L 12,900 mg/L 14,200 mg/L

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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

This material is regulated for transportation as a hazardous material/dangerous good. Flammable Liquid, n.o.s. (ethyl alcohol) Proper shipping name: UN1993 UN / ID No: 3 Hazard class: 12 C (54 F) Flash Point (C): II Packing group: For small quantities, limited to inner packaging less than or equal to 1.0L (0.3 gal) and outer packaging less than or equal to 30 kg (66 lb.) gross weight, the following apply. Note: If your commodity meets the definition of a limited quantity and is packaged for retail sale, it may also be considered a Consumer Commodity and excepted from additional requirements as applicable. IATA / ICAO IATA Proper shipping name: IATA UN / ID No: IATA Hazard Class: IATA Packing Group: IMDG IMDG Proper shipping name: IMDG UN / ID No: IMDG Hazard Class: Flash Point (C): IMDG Packing Group: DOT DOT Proper shipping name: Subject to Exemption DOT SP-9275, making it exempt from the 49 CFR regulations if: Inner packagings <=8.0 fl. Ounces; total inner packages <=192 fl.Oz.; total outer package <=66 lb. Current copy of exemption must be maintained and followed at shipping site. Flammable Liquid, n.o.s. (ethyl alcohol), Ltd Qty UN 1993 3 12 C (54 F) II Consumer Commodity ID 8000 9 Not applicable
15. REGULATORY INFORMATION

EU Symbol: EU Indication of danger: EU Risk Phrases: R11 - Highly flammable. EU Safety Phrases: S 9 - Keep container in a well-ventilated place. S16 - Keep away from sources of ignition - No smoking. F F - Highly flammable

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15. REGULATORY INFORMATION

OSHA Label: DANGER Highly flammable liquid and vapor.
Canada - WHMIS: Classifications WHMIS hazard class: Class B, Division 2 Class D, Division 2, and Subdivision B.
Ethanol California Proposition 65
Inventory - United States TSCA - Sect. 8(b) Australia (AICS): EU EINECS/ELINCS List Alprostadil Standard for the Uniform Scheduling for Drugs and Poisons: EU EINECS/ELINCS List
carcinogen, initial date 7/1/88 (when associated with alcohol abuse) developmental toxicity, initial date 10/1/87 (when in alcoholic beverages) Listed Listed 200-578-6
Schedule 4 212-017-2
16. OTHER INFORMATION

Text of R phrases mentioned in Section 3 R11 - Highly flammable. R22 - Harmful if swallowed. Data Sources: Reasons for Revision:
Pfizer proprietary drug development information. Publicly available toxicity information. Safety data sheets for individual ingredients. Updated Section 1 - Identification of the Substance/Preparation and the Company/Undertaking. 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 11 Toxicology Information. Updated Section 13 - Disposal Considerations. Updated Section 14 Transport Information. Updated Section 15 - Regulatory Information. Toxicology and Hazard Communication Pfizer Global Environment, Health, and Safety Operations
Prepared by:
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 _______________________________________________________________________________________________________ ALPROSTADIL INJECTION

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MATERIAL SAFETY DATA SHEET

Revision date: 05-Nov-2009 Page 1 of 8

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

Material Name: Alprostadil Concentrate for Solution for Infusion

Known Clinical Effects:

EU Indication of danger: EU Hazard Symbols: