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SAFETY DATA SHEET - Pfizer

1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGP roduct IdentifierMaterial Name: Hydromorphone Hydrochloride Injection, USP CII (Hospira Inc.)Trade Name:Hydromorphone Hydrochloride Injection, USPC hemical Family:MixtureRelevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use:Pharmaceutical product used as analgesicDetails of the Supplier of the SAFETY data Sheet2. HAZARDS IDENTIFICATIONC lassification of the Substance or MixtureGHS - ClassificationReproductive Toxicity: Category 2 Label ElementsSignal Word:WarningHazard Statements:H361d - Suspected of damaging the unborn childPrecautionary Statements:P201 - Obtain special instructions before useP202 - Do not handle until all SAFETY precautions have been read and understoodP280 - Wear protective gloves/

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

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Transcription of SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGP roduct IdentifierMaterial Name: Hydromorphone Hydrochloride Injection, USP CII (Hospira Inc.)Trade Name:Hydromorphone Hydrochloride Injection, USPC hemical Family:MixtureRelevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use:Pharmaceutical product used as analgesicDetails of the Supplier of the SAFETY data Sheet2. HAZARDS IDENTIFICATIONC lassification of the Substance or MixtureGHS - ClassificationReproductive Toxicity: Category 2 Label ElementsSignal Word:WarningHazard Statements:H361d - Suspected of damaging the unborn childPrecautionary Statements:P201 - Obtain special instructions before useP202 - Do not handle until all SAFETY precautions have been read and understoodP280 - Wear protective gloves/protective clothing/eye protection/face protectionP308 + P313 - IF exposed or concerned.

2 Get medical attention/adviceP405 - Store locked upP501 - Dispose of contents/container in accordance with all local and national regulations_____PZ03091 Hospira, A Pfizer Company275 North Field DriveLake Forest, Illinois 600451-800-879-3477 Hospira UK LimitedHorizonHoney LaneHurleyMaidenhead, SL6 6 RJUnited KingdomRevision date: 03-Aug-2016 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887 Version: SAFETY data SHEETPage 1 of 8 SAFETY data SHEET_____Other HazardsAn Occupational Exposure Value has been established for one or more of the ingredients (seeSection 8).

3 Note:This document has been prepared in accordance with standards for workplace SAFETY , whichrequires the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warning 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%Hydromorphone Hydrochloride71-68-1200-762-6 Acute Tox 3 (H301)(H361d) NumberEUEINECS/ELINCSListGHS Classification%Water for Injection7732-18-5231-791-2 Not Listed*Citric acid, anhydrous77-92-9201-069-1 Not Listed*Sodium Citrate6132-04-3 Not ListedNot Listed*Additional Information.

4 * ProprietaryIngredient(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. 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 :Never give anything by mouth to an unconscious person.

5 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 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 2 of 8 Revision date: 03-Aug-2016 Material Name: Hydromorphone Hydrochloride Injection, USPCII (Hospira Inc.)Version: SAFETY data SHEET_____Medical ConditionsAggravated by Exposure:None knownIndication of the Immediate Medical Attention and Special Treatment NeededNotes to Physician:None5.

6 FIRE FIGHTING MEASURESE xtinguishing Media:Extinguish fires with CO2, extinguishing powder, foam, or Hazards Arising from the Substance or MixtureHazardous CombustionProducts:Formation of toxic gases is possible during heating or / Explosion Hazards:Not applicableAdvice 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).

7 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. 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.

8 Avoid contact with eyes, skin and clothing. When handling, use appropriate personal protectiveequipment (see Section 8). Wash thoroughly after handling. Releases to the environment should be avoided. Review andimplement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure orenvironmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dustcollectors, HEPA filtration systems or other equivalent for Safe Storage, Including any IncompatibilitiesStorage Conditions:Store as directed by product end use(s):Pharmaceutical drug product8.

9 EXPOSURE CONTROLS / PERSONAL PROTECTIONC ontrol ParametersRefer to available public information for specific member state Occupational Exposure date: 03-Aug-2016 Material Name: Hydromorphone Hydrochloride Injection, USPCII (Hospira Inc.)Version: 3 of 8 SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONThe purpose of the Occupational Exposure Band (OEB) classification system is to separate substances into different Hazard categorieswhen the available data are sufficient to do so, but inadequate to establish an Occupational Exposure Limit (OEL).

10 The OEB given isbased upon an analysis of all currently available data ; as such, this value may be subject to revision when new information ControlsEngineering 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 ProtectiveEquipment:Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).


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