Caspofungin Acetate for Injection 50mg and 70mg

Hazard statements (CLP)

H318, H361, H400

Code

Statements

H318

Causes serious eye damage

Signal word

DANGER! GHS Class: Reproductive Toxicity, Category 2 Eye Damage, Category 1 Hazardous to the aquatic environment, Acute, Category 1

Hazard statements

H318: Causes serious eye damage. H361: Suspected of damaging fertility or the unborn child. H400: Very toxic to aquatic life.

Precautionary statements

P310: Immediately call a POISON CENTER or doctor/physician. P391: Collect spillage. P201: Obtain special instructions before use. P280: Wear protective gloves/protective clothing/eye protection/face protection. P202: Do not handle until all safety precautions have been read and understood. P281: Use personal protective equipment as required. P260: Avoid breathing dust/fume/gas/mist/vapours/spray. P264: Wash hands thoroughly after handling. P305+P351+P338 IF IN EYES Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P273: Avoid release to the environment. Hazards not otherwise classified that have been identified during the classification process: 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: Severe eye irritation. Skin: May cause skin irritation. Inhalation: May cause irritation of respiratory tract. Ingestion: This route of entry is unlikely. If ingested, substance is considered non-toxic. Caspofungin acetate Signs/Symptoms: The most common adverse effects reported in patients were fever, headache, infused vein complications, nausea, vomiting, flushing and chills. In humans, possible histamine-mediated symptoms have been reported including rash, facial swelling, itching, sensation of warmth, or bronchospasm. Anapylaxis has been reported. These effects have been reported in individuals receiving the drug intravenously and their relevance to workplace exposures is unknown. Liver function test abnormalities have occurred in healthy volunteers and patients receiving cancidas. Repeat-dose intravenous (IV) studies in animals resulted in systemic reactions attributed to histamine release and liver toxicity in the rat and monkey. Fertility and reproductive performance were not affected by the intravenous administration of caspofungin to rats. It was shown to cause adverse developmental effects in rats and rabbits and was found in the milk of lactating, drug-treated rats. Aggravation of Pre-Existing Individuals with moderate liver insufficiency will be more sensitive. Conditions: