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.

2 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).

3 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.

4 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.

5 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.

6 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). 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.

7 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.

8 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.

9 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.

10 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).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.)