MATERIAL SAFETY DATA SHEET - pfizer.com

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Alprostadil Concentrate for Solution for InfusionTrade Name:Prostin VR Pediatric Sterile Solution; ProstivasChemical Family:MixtureIntended Use:Indicated to temporarily maintain the patency of the ductus arteriosus until surgery can beperformjed in neonates who have congenital heart defects and who depend upon the patentductus for HAZARDS IDENTIFICATIONA ppearance:Clear liquidSignal Word:DANGERS tatement of Hazard:Highly flammable liquid and Hazard Information:Short Term:May cause eye and skin irritation. May be harmful if absorbed through the skin. May beharmful if swallowed. Harmful if inhaled . Exposure to high concentrations may cause irritation,headache, drowsiness, and symptoms of alcohol Term:Repeat-dose studies in animals have shown a potential to cause adverse effects onreproductive system, the developing fetus. This product contains ethanol which can causeliver changes, central nervous system effects, and birth defects in the developing fetusKnown Clinical Effects:Clinical use of this drug has caused symptoms of asthma, vomiting, diarrhea, increasedbleeding time, clotting abnormalities, flushing, decrease in blood pressure (hypotension),decreased heart rate (bradycardia).

2 Stimulates smooth muscle Indication of danger:F - Highly flammableEU Hazard Symbols:EU Risk Phrases:R11 - Highly Hazard Classification(NOHSC):Hazardous Substance. Dangerous INJECTIONPage 1 of 8 Contact MATERIAL SAFETY DATA SHEETP fizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222 pfizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Revision date: 05-Nov-2009 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Emergency telephone number:ChemSafe (24 hours): +44 (0)208 762 8322 MATERIAL SAFETY DATA SHEET_____2. HAZARDS IDENTIFICATIONNote:This document has been prepared in accordance with standards for workplace SAFETY , whichrequire the inclusion of all known hazards of the active substance or its intermediatesregardless of the potential risk. The precautionary statements and warnings included may notapply in all cases. Your needs may vary depending upon the potential for exposure in COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS ListClassification%Ethanol64-17-5200-578 -6F; ; Information:Ingredient(s) indicated as hazardous have been assessed under standards for the full text of the R phrases mentioned in this Section, see Section 164.

3 FIRST AID MEASURESEye Contact:Flush with water while holding eyelids open for at least 15 minutes. Seek medical Contact:Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical :Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention :Remove to fresh air and keep patient at rest. Seek medical attention and Effects of Exposure:For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological FIRE FIGHTING MEASURESE xtinguishing Media:Use carbon dioxide, dry chemical, or water Combustion Products:Carbon dioxide, carbon monoxideFire Fighting Procedures:During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing / Explosion Hazards:Flammable liquid and vapor. Vapors are heavier than air and may travel along surfaces toremote ignition sources and flash ACCIDENTAL RELEASE MEASURESH ealth and SAFETY Precautions:Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8).

4 Minimize exposure. Eliminate all sources of ignition and ventilate area usingexplosion-proof INJECTIONM aterial Name: Alprostadil Concentrate for Solution forInfusionPage 2 of 8 Revision date: 05-Nov-2009 MATERIAL SAFETY DATA SHEET_____Measures for Cleaning / Collecting:Contain the source of spill if it is safe to do so. Collect spill with absorbent MATERIAL . Clean spillarea for EnvironmentalProtections:Place waste in an appropriately labeled, sealed container for disposal. Care should be taken toavoid environmental Consideration for LargeSpills:Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained HANDLING AND STORAGEG eneral Handling:Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist. Wash thoroughlyafter handling. Use with adequate ventilation. Keep away from heat, sparks, flame and allother sources of Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure INJECTIONF rance OEL - TWAL istedAustralia TWA1000 ppm1880 mg/m3 Germany - TRGS 900 - TWAs500 ppm960 mg/m3 EthanolGermany (DFG) - MAK500 ppm MAK960 mg/m3 MAKA ustria OEL - MAKsGreece OEL - TWAL istedListedHungary OEL - TWAL istedMaterial Name: Alprostadil Concentrate for Solution forInfusionIreland OEL - TWAsListedBelgium OEL - TWAL istedLatvia OEL - TWAL istedLithuania OEL - TWAL istedACGIH Threshold Limit Value (TWA)OSHA - Final PELS - TWAs.

5 1000 ppm1900 mg/m3 Bulgaria OEL - TWAL istedPoland OEL - TWAL isted1000 ppm TWAPage 3 of 8 Portugal OEL - TWAL istedCzech Republic OEL - TWAR omania OEL - TWAL istedListedSlovenia OEL - TWAL istedSpain OEL - TWAL istedDenmark OEL - TWAL istedSweden OEL - TWAsListedACGIH OELs - Notice of Intended ChangesAlprostadilListedPfizer OEL TWA-8 g/m3 Estonia OEL - TWAL istedFinland OEL - TWAL istedRevision date: 05-Nov-2009 MATERIAL SAFETY DATA SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONA nalytical Method:Analytical method available for Alprostadil. Contact pfizer Inc for further Controls:Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this Exposure Controls:Refer to specific Member State legislation for requirements under Community Protective Equipment:Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).

6 Hands:Wear impervious gloves if skin contact is :Wear SAFETY glasses or goggles if eye contact is :Wear protective clothing when working with large protection:If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the PHYSICAL AND CHEMICAL PROPERTIESS olvent Solubility:Soluble: AlcoholsFlammablity:Flash Point (Liquid) ( C) Closed cup (Ethanol)Upper Explosive Limits (Liquid) (% by Vol.):19 Lower Explosive Limits (Liquid) (% by Vol.) STABILITY AND REACTIVITYS tability:Stable under normal conditions of to Avoid:Keep away from heat, spark, flames and all other sources of Materials:Reacts violently with peroxides. Acids, Acid chlorides, Acid anhydrides, Alkali metals,Ammonia, Strong oxidising Decomposition Products:Thermal decomposition products may include carbon monoxide and carbon dioxide11. TOXICOLOGICAL INFORMATIONG eneral Information:The information included in this section describes the potential hazards of the Toxicity: (Species, Route, End Point, Dose)_____ALPROSTADIL INJECTIONM aterial Name: Alprostadil Concentrate for Solution forInfusionMolecular Formula:MixtureAlprostadilPage 4 of 8 Rat Oral LD 50 228 mg/kgMolecular Weight:MixtureRat Intravenous LD 50 mg/kgRat Intraperitoneal LD 50 mg/kgPhysical State:LiquidMouse Oral LD 50 186 mg/kgColor:ClearRevision date: 05-Nov-2009 Odor:Alcohol like MATERIAL SAFETY DATA SHEET_____11.

7 TOXICOLOGICAL INFORMATIONI rritation / Sensitization: (Study Type, Species, Severity)Reproduction & Development Toxicity: (Duration, Species, Route, Dose, End Point, Effect(s))Genetic Toxicity: (Study Type, Cell Type/Organism, Result)Carcinogen Status:None of the components of this formulation are listed as a carcinogen by IARC, NTP or ECOLOGICAL INFORMATIONE nvironmental Overview:Environmental properties have not been investigated. Releases to the environment should Toxicity: (Species, Method, End Point, Duration, Result)_____ALPROSTADIL INJECTIONE thanolRat Oral LD50 7,060 mg/kgIARC:Group 1 AlprostadilNTP:ListedMouse Intravenous LD 50 21 mg/kgOSHA:Present Not specified Rat Oral 1 mg/kg/day Maternal toxicity, Reproductive toxicityMouse Inhalation LC50 4h 39 g/m3 Revision date: 05-Nov-2009 AlprostadilRat Inhalation LC50 10h 20,000 ppmBacterial Mutagenicity (Ames) Salmonella NegativeEthanolEthanolFingerling Trout NPDES LC50 24 Hours 11,200 mg/LUnscheduled DNA Synthesis NegativeRainbow Trout NPDES LC50 96 Hours 12,900 mg/LMaterial Name.

8 Alprostadil Concentrate for Solution forInfusionFathead minnow NPDES LC50 96 Hours 14,200 mg/LPage 5 of 8 Mammalian Cell Mutagenicity HGPRT NegativeEthanolMouse Oral LD50 3,450 g/m3 Eye Irritation Rabbit Severe MATERIAL SAFETY DATA SHEET_____13. DISPOSAL CONSIDERATIONSD isposal Procedures:Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the MATERIAL , review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and TRANSPORT INFORMATIONThis MATERIAL is regulated for transportation as a hazardous MATERIAL /dangerous shipping name:Flammable Liquid, (ethyl alcohol)UN / ID No:UN1993 Hazard class:3 Flash Point ( C):12 C (54 F)Packing group:IIFor small quantities, limited to inner packaging less than or equal to ( gal) and outer packaging less than or equal to 30 kg (66lb.)

9 Gross weight, the following apply. Note: If your commodity meets the definition of a limited quantity and is packaged for retail sale, itmay also be considered a Consumer Commodity and excepted from additional requirements as / ICAOIATA Proper shipping name:Consumer CommodityIATA UN / ID No:ID 8000 IATA Hazard Class:9 IATA Packing Group:Not applicableIMDGIMDG Proper shipping name:Flammable Liquid, (ethyl alcohol), Ltd QtyIMDG UN / ID No:UN 1993 IMDG Hazard Class:3 Flash Point ( C):12 C (54 F)IMDG Packing Group:IIDOTDOT Proper shipping name:Subject to Exemption DOT SP-9275, making it exempt from the 49 CFR regulations if: Innerpackagings <= fl. Ounces; total inner packages <=192 ; total outer package <=66 copy of exemption must be maintained and followed at shipping REGULATORY INFORMATIONEU Symbol:FEU Indication of danger:F - Highly flammableEU Risk Phrases:R11 - Highly SAFETY Phrases:S 9 - Keep container in a well-ventilated - Keep away from sources of ignition - No INJECTIONR evision date: 05-Nov-2009 MATERIAL Name: Alprostadil Concentrate for Solution forInfusionPage 6 of 8 MATERIAL SAFETY DATA SHEET_____15.

10 REGULATORY INFORMATIONOSHA Label:DANGERH ighly flammable liquid and - WHMIS: ClassificationsWHMIS hazard class:Class B, Division 2 Class D, Division 2, and Subdivision OTHER INFORMATIONText of R phrases mentioned in Section 3R11 - Highly - Harmful if Sources: pfizer proprietary drug development information. Publicly available toxicity information. Safetydata sheets for individual for Revision:Updated Section 1 - Identification of the Substance/Preparation and the Section 2 - Hazard Identification. Updated Section 3 - Composition / Information onIngredients. Updated Section 4 - First Aid Measures. Updated Section 7 - Handling andStorage. 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 by:Toxicology and Hazard CommunicationPfizer Global Environment, Health, and SAFETY OperationsPfizer Inc believes that the information contained in this MATERIAL SAFETY Data SHEET is accurate, and while it is provided in good faith, itis without warranty of any kind, expressed or implied.