None identified

Hazard statements (CLP)

H302, H312, H315, H319, H340, H351, H361fd, H372, H411

Code

Statements

H302

Harmful if swallowed

2.1 Classification of the substance or mixture

Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labelling listed below is for bulk Gemcitabine for Injection/Infusion. Regulation (EC) 1272/ Acute toxicity - oral - Category 4. Acute toxicity - dermal - Category 4. Irritant 2008 [GHS] (skin) - Category 2. Irritant (eye) - Category 2. Reproductive Toxicity - Category 2. Germ Cell Mutagenicity - Category 1B. Carcinogenic - Category 2. Specific Target Organ Toxicity (repeated exposure) - Category 1. Aquatic toxicity (chronic) - Category 2. Directive 67/548/EEC T - R21/22, R36/38, R40 (Carc. Cat. 3), R46 (Muta. Cat. 2), R62 (Repr. Cat. 3), or 1999/45/EC R63 (Repr. Cat. 3); N - R51/53

Signal word

Danger Caution US Hazard overview Mixture contains gemcitabine - a cytotoxic anticancer agent. May be harmful if swallowed. May be harmful if absorbed through skin. May cause skin irritation. May cause eye irritation. Possible Reproductive/Developmental hazard - may cause adverse reproductive/developmental effects (based on animal data). Genotoxic. Can cause blood, bone marrow, and gastrointestinal, damage. May cause testicular damage based on animal data. Toxic to aquatic life with long- lasting effects. Actavis-Ro #6 - Gemcitabine 200mg Powder for Solution for Infusion Actavis Revision Date: 05 January 2011, Version 1.0.0 Page 3 of 13 SECTION 2 - HAZARDS IDENTIFICATION …continued Note This mixture is classified as dangerous/hazardous according to Directive 67/548/ EEC, Regulation EC No 1272/2008 (EU CLP), and applicable US regulations. The GHS classifications are based on Regulation (EC) 1272/2008. The EU symbol/ indicator of danger, R Phrases and Safety Advice are based on Directive 67/548/ EEC or 1999/45/EC.

CLP CLASSIFICATION

H302 - Harmful if swallowed. H312 - Harmful in contact with skin. H315 - Causes

Hazard statements

skin irritation. H319 - Causes serious eye irritation. H340 - May cause genetic defects. H351 - Suspected of causing cancer. H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child. H372 - Causes damage to the blood, bone marrow, gastrointestinal tract, and testes through prolonged or repeated exposure. H411 - Toxic to aquatic life with long-lasting effects. CLP/GHS P201 - Obtain special instructions before use. P202 - Do not handle until all safety

Precautionary statements

precautions have been read and understood. P260 - Do not breathe dust. P270 Do not eat, drink or smoke when using this product. P273 - Avoid release to the environment. P281 - Use personal protective equipment as required. P301+P312: IF SWALLOWED: Call a Poison Center or doctor/physician if you feel unwell. P302 + P352 - If on skin: Wash with plenty of soap and water. P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P314 - Get medical advice/attention if you feel unwell. P321 - Specific treatment (see First Aid information on product label and/or Section 4 of the SDS). P330 - Rinse mouth. P362 - Take off contaminated clothing and wash before reuse. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations. Actavis-Ro #6 - Gemcitabine 200mg Powder for Solution for Infusion Actavis Revision Date: 05 January 2011, Version 1.0.0 Page 2 of 13 SECTION 2 - HAZARDS IDENTIFICATION …continued EU symbol/indication of danger T - Toxic N - Dangerous for the environment Risk (R) Phrase(s) R21/22 - Harmful in contact with skin and if swallowed. R36/38 - Irritating to eyes and skin. R40 - Limited evidence of a carcinogenic effect. R46 - May cause heritable genetic damage. R62 - Possible risk of impaired fertility. R63 - Possible risk of harm to the unborn child. R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. S24 - Avoid contact with skin. S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36/37 - Wear suitable protective clothing and gloves. S53 - Avoid exposure - Obtain special instructions before use. S57 - Use appropriate container to avoid environmental contamination. S60 - This material and its container must be disposed of as hazardous waste. S61 - Avoid release to the environment. Refer to special instructions/safety data sheets.

2.3 Other hazards

Contains gemcitabine, a cytotoxic agent. The most commonly reported adverse effects associated with gemcitabine use include blood and bone marrow suppression (dose-limiting), edema, gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea, constipation), hair loss, "flu-like" symptoms, and fever. Small changes to liver and kidney parameters were also noted. There are scientific studies that suggest personnel (e.g., nurses, pharmacists) who prepare and administer parenteral antineoplastics may be at some risk due to potential mutagenicity, adverse effects on reproduction and/or carcinogenicity if these materials are not properly controlled in the workplace. The actual risk in the workplace is not known.