Gemcitabine Hydrochloride for Injection 40 mg/ml

Hazard statements (CLP)

H312, H315, H319, H341

Code

Statements

H312

Harmful in contact with skin

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 labeling listed below is for bulk Gemcitabine Hydrochloride.

Hazard statements

Product is a white, or off-white powder. The active material may enter the body through the skin, alters genetic material and may be irritating to the eyes and skin. Effects of exposure may include decreased fertility, foetal changes and decreased blood cell counts. Specific hazards: Possible foetal development hazard that may adversely affect the developing foetus. EU Hazard Symbols: H312 Harmful in contact with skin. H315 Causes skin irritation. H319 Causes serious eye irritation. H341 Suspected of causing genetic defects.

Signal word

Warning

Precautionary statements

P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P264 Wash hands thoroughly after handling. P280 Wear protective gloves/eye protection. 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. P405 Store locked up. P501 Dispose of contents/container in accordance with national regulations. EU Risk Phrases: R21 – Harmful in contact with skin. R22 – Harmful if swallowed. R36/38 – Irritating to eyes and skin. R46 – May cause heritable genetic damage. R62 – Possible risk of impaired fertility. R63 – Possible risk of harm to the unborn child. EU Indication of Danger: Harmful. Irritant. Toxic to Reproduction, Category 3. Mutagenic, Category 2. Principle Routes of Entry: Inhalation and skin absorption. Inhalation: Inhalation is not considered likely under normal usage conditions, due to the small quantity of material within each vial. If inhaled, may cause fibrosis. Ingestion: Harmful if swallowed (based upon animal data). Effects including decreased blood cell counts, mouth sores, diarrhoea, tiredness, weakness, wheezing, bruising, hair loss, bloody stools, headache, rhinitis, constipation, muscle pain, sweating, drowsiness, sleep disturbance, shortness of breath, nausea, vomiting, oedema, rash, fever, elevated liver enzymes and flu-like symptoms. Skin Contact: May cause irritation and/or allergic reactions, particularly to cut or abraded skin. Eye Contact: May cause eye irritation. May cause allergic reaction. Effects may include stinging, watering, redness and swelling of the eyes.