MATERIAL SAFETY DATA SHEET - Pfizer

1 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKINGM aterial Name: Methylprednisolone TabletsTrade Name:MEDROLC hemical Family:Corticosteroid hormoneIntended Use:Pharmaceutical active used as anti-inflammatory2. HAZARDS IDENTIFICATIONA ppearance:Tablets, varying in color depending on strengthSignal Word:DANGERS tatement of Hazard:May damage the unborn cause damage to blood and blood forming organs through prolonged or Term:May be absorbed through the skin and cause systemic Term:Repeat-dose studies in animals have shown a potential to cause adverse effects on blood andblood forming organs. May cause allergic reactions in susceptible individuals followingrepeated contact with this Clinical Effects:Adverse clinical reactions include the development of hypersensitivity and/or irritation leadingto rashes, itching, and burning.

2 Clinical use has resulted in hormonal Indication of danger:Toxic to reproduction: Category 1 HarmfulEU Hazard Symbols:EU Risk Phrases:R48/22 - Harmful: danger of serious damage to health by prolonged exposure if - May cause harm to the unborn Hazard Classification(NOHSC):Hazardous Substance. Non-Dangerous TABLETSP fizer LtdRamsgate RoadSandwich, KentCT13 9 NJUnited Kingdom+00 44 (0)1304 616161 Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300 Revision date: 06-Apr-2010 Emergency telephone number:Animal Health Division (office hours): +44 (0)1737 331333 Contact MATERIAL SAFETY data SHEETPage 1 of 8 Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222 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.

3 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 List EU Classification%Methylprednisolone83-43-2 201-476-4T;R48 ;R612, 4, 8, 16 or32mg**Calcium stearate1592-23-0216-472-8 Not Listed*Corn Starch9005-25-8232-679-6 Not Listed*Mineral oil8012-95-1232-384-2 Not Listed*Sucrose57-50-1200-334-9 Not Listed*IngredientCAS NumberEU EINECS/ELINCS List EU Classification%Lactose63-42-3200-559-2 Not Listed*Sorbic acid110-44-1203-768-7 Not Listed*Additional Information:* ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for the full text of the R phrases mentioned in this Section, see Section 164.

4 FIRST AID MEASURESEye Contact:Flush eye(s) immediately with plenty of water. If irritation occurs or persists, get Contact:Wash skin with soap and water. If irritation occurs or persists, get medical :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:May include oxides of Fighting Procedures:During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing / Explosion Hazards:Not applicable_____METHYLPREDNISOLONE TABLETSV ersion: 2 of 8 Revision date: 06-Apr-2010 MATERIAL Name: Methylprednisolone Tablets MATERIAL SAFETY data SHEET_____6.

5 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 spilled MATERIAL by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area 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:Minimize dust generation and accumulation.

6 If tablets or capsules are crushed and/or broken,avoid breathing dust and avoid contact with eyes, skin, and clothing. When handling, useappropriate personal protective equipment (see Section 8). Wash thoroughly after Conditions:Store as directed by product EXPOSURE CONTROLS / PERSONAL PROTECTIONR efer to available public information for specific member state Occupational Exposure TABLETSS pain OEL - TWAL istedCalcium stearateSweden OEL - TWAsListedVersion: StarchACGIH Threshold Limit Value (TWA)10 mg/m3 TWAACGIH Threshold Limit Value (TWA)10 mg/m3 TWAPage 3 of 8 Australia TWA10 mg/m3 Belgium OEL - TWAL istedAustralia TWA10 mg/m3 Bulgaria OEL - TWAL istedMethylprednisoloneCzech Republic OEL - TWAL istedBelgium OEL - TWAG reece OEL - TWAL istedListedIreland OEL - TWAsListedRevision date: 06-Apr-2010 OSHA - Final PELS - TWAs:15 mg/m3 total5 mg/m3 Ireland OEL - TWAsListedPortugal OEL - TWAL istedSpain OEL - TWAL istedPfizer OEL TWA-8 Hr.

7 Mineral oilLithuania OEL - TWAL isted4 g/m3, SkinPortugal OEL - TWAL istedMaterial Name: Methylprednisolone Tablets MATERIAL SAFETY data SHEET_____8. EXPOSURE CONTROLS / PERSONAL PROTECTIONA nalytical Method:Analytical method available for methylprednisolone. 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).

8 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 :Impervious protective clothing is recommended if skin contact with drug product is possible andfor bulk processing protection:If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriaterespirator with a protection factor sufficient to control exposures to below the TABLETSS weden OEL - TWAsListedACGIH Threshold Limit Value (TWA)SucroseBulgaria OEL - TWAL istedACGIH Threshold Limit Value (TWA)10 mg/m3 TWA5 mg/m3 TWAA ustralia TWA10 mg/m3 Czech Republic OEL - TWAB elgium OEL - TWAL istedListedBulgaria OEL - TWAL istedEstonia OEL - TWAL istedDenmark OEL - TWAL istedFrance OEL - TWAL istedACGIH Threshold Limit Value (STEL)Ireland OEL - TWAsListed10 mg/m3 STELL atvia OEL - TWAL istedFinland OEL - TWAL istedLithuania OEL - TWAL istedRevision date: 06-Apr-2010 OSHA - Final PELS - TWAs.

9 15 mg/m3 total5 mg/m3 Greece OEL - TWAP ortugal OEL - TWAL istedListedSpain OEL - TWAL istedIreland OEL - TWAsListedACGIH OELs - Notice of Intended ChangesListedNetherlands OEL - TWAL istedMaterial Name: Methylprednisolone TabletsOSHA - Final PELS - TWAs:5 mg/m3 Australia TWAP oland OEL - TWAL isted5 mg/m3 Version: OEL - TWAL istedPage 4 of 8 Romania OEL - TWAL istedBelgium OEL - TWAL istedSpain OEL - TWAL isted MATERIAL SAFETY data SHEET_____9. PHYSICAL AND CHEMICAL PROPERTIES10. STABILITY AND REACTIVITYC hemical Stability:Stable under normal conditions of to Avoid:Fine particles (such as dust and mists) may fuel 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)Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)_____METHYLPREDNISOLONE TABLETSM ixtureMouse Oral LD 50 450 mg/kgVersion: Intraperitoneal LD 50 1000 mg/kgMolecular Weight.

10 Mouse Intraperitoneal LD 50 1409 mg/kgMixtureRat Oral LD50 g/kgRat Subcutaneous LD 50 >3000 mg/kgPage 5 of 8 LactoseMineral oilRat Oral LD50 > 10 g/kgEye Irritation Rabbit ModeratePhysical State:Skin Irritation Rabbit MildSorbic acidMethylprednisoloneTabletsRevision date: 06-Apr-2010 Skin Irritation Rabbit No effectRat Oral LD50 7360 mg/kgEye Irritation Rabbit No effectColor:Skin Sensitization - GPMT Guinea Pig No effectMouse Oral LD50 3200 mg/kgVariousMaterial Name: Methylprednisolone TabletsMethylprednisoloneMolecular Formula:Rat Oral LD 50 > 2000 mg/kg MATERIAL SAFETY data SHEET_____11. TOXICOLOGICAL INFORMATIONR eproduction & Developmental Toxicity: (Study Type, 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 thoroughly investigated.