MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Lorazepam Solution for InjectionTrade Name:ATIVANC hemical Family:BenzodiazepineIntended Use:Pharmaceutical product used as antianxiety agent2. HAZARDS IDENTIFICATIONA ppearance:White crystalline powderStatement of Hazard:Non-hazardous in accordance with international standards for workplace Hazard Information:Short Term:May be harmful if swallowed. May cause irritation (based on components) .Long Term:Repeat-dose studies in animals have shown a potential to cause adverse effects ondeveloping fetus May cause harm to breastfed Clinical Effects:Adverse effects most commonly reported in clinical use include sedation, dizziness, weakness,clumsy motion of limbs/trunk (ataxia), incoordination, fatigue, drowsiness, amnesia, confusion,state of intense good feeling (euphoria), suicidal behavior, Benzodiazepines may cause fetaldamage when administered during pregnancy. Secreted in human breast Hazard Classification(NOHSC):Hazardous Substance.

2 Non-Dangerous :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 MATERIAL SAFETY data SHEETPage 1 of 7 Pfizer 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 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 06-May-2011 Emergency telephone number:ChemSafe (24 hours): +44 (0)208 762 8322 Contact MATERIAL SAFETY data SHEET_____3. COMPOSITION/INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEU EINECS/ELINCS List EU Classification%Lorazepam846-49-1212-687- 6R64 Repr. ; glycol57-55-6200-338-0 Not Listed*Polyethylene glycol25322-68-3 Not ListedNot Listed*Benzyl Alcohol100-51-6202-859-9Xn;R20/22*Additi onal 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:Emits toxic fumes of carbon monoxide, carbon dioxide, nitrogen oxides, hydrogen chloride andother chlorine-containing Fighting Procedures:During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing / Explosion Hazards:High sensitivity of a dust cloud to ignition, based on minimum ignition energy.

4 Strong dustexplosion ACCIDENTAL RELEASE MEASURESH ealth and SAFETY Precautions:Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8). Minimize 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 : 2 of 7 Revision date: 06-May-2011 MATERIAL Name: Lorazepam Solution for Injection MATERIAL SAFETY data SHEET_____Additional 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 breathing vapor or mist. Avoid contact with eyes, skin and clothing. When handling, useappropriate personal protective equipment (see Section 8).

5 Wash thoroughly after to the environment should be avoided. Review and implement appropriate technicaland procedural waste water and waste disposal measures to prevent occupational exposure orenvironmental releases. Potential points of process emissions of this MATERIAL to theatmosphere should be controlled with dust collectors, HEPA filtration systems or otherequivalent Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure 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:Impervious gloves are recommended if skin contact with drug product is possible and for bulkprocessing :Wear SAFETY glasses or goggles if eye contact is 3 of 7 Bulgaria OEL - TWAL istedCzech Republic OEL - TWAL istedLatvia OEL - TWAL istedLatvia OEL - TWAL istedLithuania OEL - TWAL istedLithuania OEL - TWAP oland OEL - TWAL istedListedLorazepamPropylene glycolPfizer Occupational ExposureBand (OEB):OEB 4 (control exposure to the range of >1ug/m3 to <10ug/m3)Polyethylene glycolRevision date: 06-May-2011 MATERIAL Name: Lorazepam Solution for InjectionAustria OEL - MAKsListedAustralia TWAG ermany - TRGS 900 - TWAs1000 mg/m310 mg/m3150 ppm474 mg/m3 Germany (DFG) - MAK1000 mg/m3 MAKV ersion: OEL - TWAL istedIreland OEL - TWAsListedBenzyl Alcohol MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONSkin:Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing protection:If airborne exposures are within or exceed the Occupational Exposure Band (OEB) range, wearan appropriate respirator with a protection factor sufficient to control exposures to the bottom ofthe OEB PHYSICAL AND CHEMICAL PROPERTIESDust Explosivity:Polymerization:Will not occur10.

7 STABILITY AND REACTIVITYC hemical Stability:Stable at normal conditionsConditions to Avoid:Keep away from heat and other sources of ignition, including electrostatic Materials:As a precautionary measure, keep away from strong oxidizers11. TOXICOLOGICAL INFORMATIONG eneral Information:The information included in this section describes the potential hazards of the Toxicity: (Species, Route, End Point, Dose)Acute Toxicity Comments:A greater than symbol (>) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the / Sensitization: (Study Type, Species, Severity)_____WP00036 Rat Inhalation LC50 46 mg/m3 Molecular Formula:MixturePropylene glycolPage 4 of 7 Mouse Oral LD50 22,000 mg/kgMolecular Weight:MixtureRat Oral LD50 20,000 mg/kgRabbit Dermal LD50 20,800 mg/kgLorazepamRevision date: 06-May-2011 Mouse Oral LD50 1850 mg/kgBenzyl AlcoholPhysical State:LiquidEye Irritation Rabbit SevereBenzyl AlcoholSkin Irritation Rabbit ModerateMaterial Name: Lorazepam Solution for InjectionSkin Irritation Guinea Pig ModerateRat Oral LD50 1230 mg/kgColor.

8 No data Para-periosteal LD50 53 mg/kgVersion: MATERIAL SAFETY data SHEET_____11. TOXICOLOGICAL INFORMATIONR eproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))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 thoroughly investigated. Releases to the environmentshould be DISPOSAL CONSIDERATIONSW aste Treatment Methods: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.

9 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 INFORMATIONThe following refers to all modes of transportation unless specified regulated for transport under USDOT, EUADR, IATA, or IMDG REGULATORY INFORMATIONEU Symbol:TEU SAFETY Phrases:_____WP00036 Propylene glycolSkin Irritation Rabbit MildSkin Irritation Rabbit MildLorazepamRevision date: 06-May-2011 Fertility and Embryonic Development Rabbit Intravenous 40 mg/kg/day LOAEL FetotoxicityEye Irritation Rabbit MildMaterial Name: Lorazepam Solution for InjectionLorazepamPolyethylene glycol18 Month(s) Rat Oral Not carcinogenicVersion: 5 of 718 Month(s) Mouse Oral Not carcinogenicEye Irritation Rabbit Mild MATERIAL SAFETY data SHEET_____15. REGULATORY INFORMATIONS22 - Do not breathe - Wear suitable protective clothing and - In case of accident or if you feel unwell seek medical advice immediately (show the labelwhere possible).

10 S53 - Avoid exposure - obtain special instructions before Label:Non-hazardous in accordance with international standards for workplace - WHMIS: ClassificationsWHMIS hazard class:D2a very toxic materialsAdditional Information:US DEA Schedule IV substance16. OTHER INFORMATIONText of R phrases and GHS Classification abbreviations mentioned in Section 3R61 - May cause harm to the unborn - May cause harm to breastfed - Harmful by inhalation and if Sources:Publicly available toxicity information. Pfizer proprietary drug development - United States TSCA - Sect. 8(b)ListedPage 6 of 7 Australia (AICS):ListedBenzyl AlcoholAustralia (AICS):ListedInventory - United States TSCA - Sect. 8(b)ListedAustralia (AICS):ListedEU EINECS/ELINCS ListEU EINECS/ELINCS List202-859-9212-687-6 LorazepamPropylene glycolRevision date: 06-May-2011 MATERIAL Name: Lorazepam Solution for InjectionInventory - United States TSCA - Sect. 8(b)ListedCalifornia Proposition 65 Australia (AICS):Listeddevelopmental toxicity, initial date 7/1/90EU EINECS/ELINCS List200-338-0 Version: Drug Enforcement Administration:Schedule IV Controlled Substance MATERIAL SAFETY data SHEET_____Prepared by:Product Stewardship Hazard CommunicationsPfizer 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.