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SAFETY DATA SHEET - pfizer.com

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGP roduct IdentifierMaterial Name: Ketorolac Tromethamine Injection, USP (Hospira Inc.)Trade Name:Not establishedSynonyms:Ketorolac trometamolChemical Family:MixtureRelevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use:Pharmaceutical product used as non-steroidal, anti-inflammatory drug (nsaid)Details of the Supplier of the SAFETY data Sheet2. HAZARDS IDENTIFICATIONC lassification of the Substance or MixtureGHS - ClassificationReproductive Toxicity: Category 1 ASpecific target organ systemic toxicity (repeated exposure): Category 2 Label ElementsSignal Word:DangerHazard Statements:H360D - May damage the unborn childH373 - May cause damage to organs through prolonged or repeated exposurePr

SAFETY DATA SHEET _____ Other Hazards An Occupational Exposure Value has been established for one or more of the ingredients (see Section 8).

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Transcription of SAFETY DATA SHEET - pfizer.com

1 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGP roduct IdentifierMaterial Name: Ketorolac Tromethamine Injection, USP (Hospira Inc.)Trade Name:Not establishedSynonyms:Ketorolac trometamolChemical Family:MixtureRelevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use:Pharmaceutical product used as non-steroidal, anti-inflammatory drug (nsaid)Details of the Supplier of the SAFETY data Sheet2. HAZARDS IDENTIFICATIONC lassification of the Substance or MixtureGHS - ClassificationReproductive Toxicity: Category 1 ASpecific target organ systemic toxicity (repeated exposure): Category 2 Label ElementsSignal Word:DangerHazard Statements:H360D - May damage the unborn childH373 - May cause damage to organs through prolonged or repeated exposurePrecautionary Statements.

2 P201 - Obtain special instructions before useP202 - Do not handle until all SAFETY precautions have been read and understoodP260 - Do not breathe dust/fume/gas/mist/vapors/sprayP280 - Wear protective gloves/protective clothing/eye protection/face protectionP308 + P313 - IF exposed or concerned: Get medical attention/adviceP314 - Get medical attention/advice if you feel unwellP405 - Store locked upP501 - Dispose of contents/container in accordance with all local and national regulations_____PZ03100 Hospira, A pfizer Company275 North Field DriveLake Forest, Illinois 600451-800-879-3477 pfizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Version: telephone number:CHEMTREC (24 hours): 1-800-424-9300 SAFETY data SHEETE mergency telephone number:International CHEMTREC (24 hours).

3 +1-703-527-3887 Page 1 of 12 Contact date: 03-Aug-2016 SAFETY data SHEET_____Other HazardsAn Occupational Exposure Value has been established for one or more of the ingredients (seeSection 8).Note:This document has been prepared in accordance with standards for workplace SAFETY , whichrequire the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warnings included may not apply in all needs may vary depending upon the potential for exposure in your COMPOSITION / INFORMATION ON INGREDIENTSH azardousIngredientCAS NumberEUEINECS/ELINCSListGHS Classification%Ketorolac tromethamine74103-07-4 Not ListedAcute (H301)STOT RE 2 (H373) (H360D) Liq.

4 2 (H225)7 - 12 Hydrochloric Acid7647-01-0231-595-7 Press. GasSkin (H314)Acute (H331)**Sodium hydroxide1310-73-2215-185-5 Skin (H314)**IngredientCAS NumberEUEINECS/ELINCSListGHS Classification%Water for injection7732-18-5231-791-2 Not Listed*Sodium chloride7647-14-5231-598-3 Not Listed*Additional Information:* Proprietary** to adjust pHIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety. In accordance with 29 CFR , the exact percentage composition of thismixture has been withheld as a trade the full text of the CLP/GHS abbreviations mentioned in this Section, see Section 164.

5 FIRST AID MEASURESD escription of 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 date: 03-Aug-2016 Material Name: Ketorolac Tromethamine Injection, USP(Hospira Inc.)Version: 2 of 12 SAFETY data SHEET_____Ingestion:Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel.

6 Seek medical attention :Remove to fresh air and keep patient at rest. Seek medical attention Important Symptoms and Effects, Both Acute and DelayedSymptoms and Effects ofExposure:For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological ConditionsAggravated by Exposure:None knownIndication of the Immediate Medical Attention and Special Treatment NeededNotes to Physician:None5. FIRE FIGHTING MEASURESE xtinguishing Media:Use carbon dioxide, dry chemical, or water Hazards Arising from the Substance or MixtureHazardous CombustionProducts:Formation of toxic gases is possible during heating or / Explosion Hazards.

7 Fine particles (such as mists) may fuel for Fire-FightersDuring all fire fighting activities, wear appropriate protective equipment, including self-contained breathing ACCIDENTAL RELEASE MEASURESP ersonal Precautions, Protective Equipment and Emergency ProceduresPersonnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize PrecautionsPlace waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental and Material for Containment and Cleaning UpMeasures for Cleaning /Collecting:Contain the source of spill if it is safe to do so.

8 Collect spill with absorbent material. Clean spillarea Consideration forLarge Spills:Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained HANDLING AND STORAGEP recautions for Safe HandlingAvoid breathing vapor or mist. Avoid contact with eyes, skin and clothing. When handling, use appropriate personal protectiveequipment (see Section 8). Wash hands and any exposed skin after removal of PPE. Releases to the environment should beavoided.

9 Review and implement appropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure or environmental releases. Potential points of process emissions of this material to the atmosphereshould be controlled with dust collectors, HEPA filtration systems or other equivalent for Safe Storage, Including any IncompatibilitiesStorage Conditions:Store as directed by product end use(s):Pharmaceutical product used as non-steroidal, anti-inflammatory drug (nsaid)_____PZ03100 Page 3 of 12 Revision date: 03-Aug-2016 Material Name: Ketorolac Tromethamine Injection, USP(Hospira Inc.)

10 Version: SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONC ontrol ParametersRefer to available public information for specific member state Occupational Exposure - TRGS 900 - TWAs500 ppm960 mg/m3 Material Name: Ketorolac Tromethamine Injection, USP(Hospira Inc.)Germany (DFG) - MAK500 ppm960 mg/m3 Austria OEL - MAKs1000 ppm1900 mg/m3 Greece OEL - TWA1000 ppm1900 mg/m3 Version: OEL - TWA1900 mg/m3 Belgium OEL - TWAL atvia OEL - TWA1000 mg/m31000 ppm1907 mg/m3 Lithuania OEL - TWA500 ppm1000 mg/m3 EthanolNetherlands OEL - TWA260 mg/m3 Bulgaria OEL - TWA1000 mg/m3 OSHA - Final PELS - TWAs.


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