SECTION 1. PRODUCT AND COMPANY IDENTIFICATION
Product name Infliximab Formulation - (OGN)
SECTION 2. HAZARDS IDENTIFICATION GHS Classification Not a hazardous substance or mixture. GHS label elements No hazard pictogram, no signal word, no hazard statement(s), no precautionary statement(s) re- quired Other hazards Dust contact with the eyes can lead to mechanical irritation. Contact with dust can cause mechanical irritation or drying of the skin. May form explosive dust-air mixture during processing, handling or other means. SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance / Mixture : Mixture

SECTION 4. FIRST AID MEASURES

employed in the cleanup of releases. You will need to determine which regulations are applicable. Sections 13 and 15 of this SDS provide information regarding certain local or national requirements.

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Ensure adequate ventilation, especially in confined areas. Minimize workplace exposure concentrations. Apply measures to prevent dust explosions. Ensure that dust-handling systems (such as exhaust ducts, dust collectors, vessels, and processing equipment) are designed in a manner to prevent the escape of dust into the work area (i.e., there is no leakage from the equipment).
SECTION 10. STABILITY AND REACTIVITY
SECTION 11. TOXICOLOGICAL INFORMATION Information on likely routes of exposure Inhalation Skin contact Ingestion Eye contact Acute toxicity Not classified based on available information. Components: Sucrose: Acute oral toxicity :    LD50 (Rat): 29,700 mg/kg
Skin corrosion/irritation Not classified based on available information. Components: Infliximab: Remarks ： No data available Serious eye damage/eye irritation Not classified based on available information. Components: Infliximab: Remarks . No data available Respiratory or skin sensitization Skin sensitization Not classified based on available information. Respiratory sensitization Not classified based on available information. Germ cell mutagenicity Not classified based on available information. Components:
Carcinogenicity Not classified based on available information.
Reproductive toxicity Not classified based on available information. Components: Infliximab:
STOT-single exposure Not classified based on available information. STOT-repeated exposure Not classified based on available information. Repeated dose toxicity Components: Infliximab:
Aspiration toxicity Not classified based on available information. Experience with human exposure Components: Infliximab: Inhalation Symptoms: Nausea, Vomiting, Abdominal pain, Diarrhea, .. Fatigue, Headache, Back pain
RGANON
SECTION 12. ECOLOGICAL INFORMATION Ecotoxicity Components: Infliximab: Ecotoxicology Assessment Acute aquatic toxicity No data available .. Chronic aquatic toxicity              :  No data available Persistence and degradability No data available Bioaccumulative potential Components: Sucrose: Partition coefficient: n- octanol/water :   Pow: < 1 Mobility in soil No data available Other adverse effects No data available SECTION 13. DISPOSAL CONSIDERATIONS Disposal methods Waste from residues
SECTION 14. TRANSPORT INFORMATION International Regulations UNRTDG Not regulated as a dangerous good IATA-DGR Not regulated as a dangerous good IMDG-Code Not regulated as a dangerous good Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable for product as supplied. Domestic regulation
ORGANON
NOM-002-SCT Not regulated as a dangerous good Special precautions for user Not applicable SECTION 15. REGULATORY INFORMATION Safety, health and environmental regulations/legislation specific for the substance or mixture Federal Law for the control of chemical precursors, :    Not applicable essential chemical products and machinery for producing capsules, tablets and pills. The ingredients of this product are reported in the following inventories: AICS :    not determined
: not determined SECTION 16. OTHER INFORMATION Revision Date Date format
Full text of other abbreviations : USA. ACGIH Threshold Limit Values (TLV) NOM-010-STPS-2014 Mexico. Norm NOM-010-STPS-2014 on Chemicals Polluting : the Work Environment - Identification, Assessment and Con- trol - Appendix 1 Occupational Exposure Limits ACGIH / TWA 8-hour, time-weighted average .. NOM-010-STPS-2014 / VLE-   :    Time weighted average limit value PPT AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport by Land of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized Sys- tem; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; IBC - International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory con- centration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemi- cal Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Or- ganisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Con- centration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) Effect
Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect Loading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Develop- ment; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumu- lative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substanc- es; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Tempera- ture; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transporta- tion of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Sub- stances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recom- mendations on the Transport of Dangerous Goods: vPvB - Very Persistent and Very Bioaccumu- lative; WHMIS - Workplace Hazardous Materials Information System
:    Internal technical data, data from raw material SDSs, OECD eChem Portal search results and European Chemicals Agen- cy, http://echa.europa.eu/ The information is considered as correct, but not exhaustive, and will be used only as a guide, which is based in the current knowledge of the substance or mixture, and is applicable to proper safety precautions for the product. MX / Z8