Fluorouracil Injection, USP

Hazard statements (CLP)

H317, H334, H361, H362

Code

Statements

H317

May cause an allergic skin reaction

Signal word

DANGER. GHS Class Respiratory sensitisation. category 1. Reproductive toxicity. Category 2. Skin Sensitization. category 1. Reproductive toxicity. Effects on or via lactation.

Hazard statements

May cause allergy or asthma symptoms or breathing difficulties if inhaled. Suspected of damaging fertility or the unborn child. May cause an allergic skin reaction. May cause harm to breast-fed children.

Precautionary statements

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Do not breathe dust/fume/gas/mist/vapours/spray. Avoid breathing dust/fume/gas/mist/vapours/spray. Avoid contact during pregnancy and while nursing. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. Contaminated work clothing should not be allowed out of the workplace. Wear protective gloves/protective clothing/eye protection/face protection. In case of inadequate ventilation wear respiratory protection. IF ON SKIN: Wash with plenty of water. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. IF exposed or concerned: Get medical advice/attention. Specific treatment (see ... on this label). If skin irritation or rash occurs: Get medical advice/attention. If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. Take off contaminated clothing and wash it before reuse. Store locked up. Dispose of contents/container in accordance with Local, State, Federal and Provincial regulations. Emergency Overview This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert.

Principle Routes of Exposure

Inhalation Ingestion Eye contact Skin Absorption. Injection.

Potential health effects

Eye Visual disturbances and extreme lacrimation have been reported with therapeutic administration. Stinging and burning with blurred vision have been reported with splash contact. Permanent eye injury was not reported. Skin Quickly resolving skin irritation and discoloration have been reported after accidental splash contact. Allergic contact dermatitis has been reported with use of fluorouracil ointment. Inhalation Irritation have been experienced with patient administration. Signs/Symptoms Adverse reactions from therapeutic doses include: anorexia, nausea, dry mouth, stomatitis, diarrhea, leukopenia, thrombocytopenia, diarrhea, anemia, hair loss, nail changes, dermatitis, increased pigmentation, and skin atrophy. Occupational exposure has not been fully investigated. Aggravation of Pre-Existing Individuals with poor nutritional state, depressed bond marrow function, those with potentially serious Conditions infections, or those with a known hypersensitivity to fluorouracil.