Vidaza 25 mg/ml powder for suspension for injection

Hazard statements (CLP)

H302, H341, H350, H360FD, H372, H400, H410

Code

Statements

H302

Harmful if swallowed

SECTION 2: Hazards identification

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 Vidaza. Globally Harmonized System [GHS] Carcinogenic - Category 1B. Germ Cell Mutagenicity - Category 2. Reproductive Toxicity - Category 1B. Acute toxicity - oral - Category 4. Specific Target Organ Toxicity (repeated exposure) - Category 1. Aquatic toxicity (acute) - Category 1. Aquatic toxicity (chronic) - Category 1. (NOHSC) - HAZARDOUS SUBSTANCE DANGEROUS GOODS. CYTOTOXIC.

Signal word

Danger

Hazard statements

H302 - Harmful if swallowed. H341 - Suspected of causing genetic defects. H350 - May cause cancer. H360FD - May damage fertility. May damage the unborn child. H372 - Causes damage to hematological and gastrointestinal systems through prolonged or repeated exposure. H400 - Very toxic to aquatic life. H410 - Very toxic to aquatic life with long-lasting effects. precautions have been read and understood. P260 - Do not breathe dust. P264 - Wash hands thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P273 - Avoid release to the environment. P281 - Use personal protective equipment as required. P308 + P313 - If exposed or concerned: get medical advice/attention. P301+P312 IF SWALLOWED Call a Poison Center or doctor/physician if you feel unwell. P314 - Get medical advice/attention if you feel unwell. P330 - Rinse mouth. P391 - Collect spillage. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/regional/ national/international regulations. Additional elements SECTION 2 - HAZARDS IDENTIFICATION …continued

Precautionary statements

P201 - Obtain special instructions before use. P202 - Do not handle until all safety

2.3 Other hazards

The most commonly occurring adverse effects with therapeutic use include hematological toxicity (e.g., thrombocytopenia, anemia, neutropenia), fever, gastrointestinal effects (e.g., nausea, vomiting, diarrhea, constipation), fatigue, injection site erythema, ecchymosis (skin discoloration caused by escape of blood into tissues from ruptured blood vessels). Other effects may include hypotension, shortness of breath, liver/kidney toxicity and electrolyte abnormalities. Post- marketing reports of interstitial lung disease and tumor lysis syndrome may also be azacitidine-related. Note This mixture is classified as hazardous under GHS as implemented by Regulation