General Information
Revision date
2017-09-28
Product name
Vyxeos
Chemical name
For Active Ingredients Daunorubicin Hydrochloride / Cytarabine
1.2.1 Relevant identified uses
Cancer treatment
Icons in SDS
Company Information
company name
Jazz Pharmaceuticals, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
jazzpharma@medcomsol.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H315, H317, H334, H341, H351, H360DF, H360FD, H412
Hazard statements
Code
Statements
H315
Causes skin irritation
Section 2
2.1 Classification of the substance or mixture
2017 Aquatic Chronic Toxicity Category 3 (H412) GHS/OSHA/CLP (1272/2008) Classification: 07 18 34 Respiratory Sensitization Category 1 (H334) Effective Skin Sensitization Category 1 (H317) Germ Cell Mutagenicity Category 2 (H341) Reproductive Toxicity Category 1B (H360FD) 10,
2.2 Label elements
Oct Note: Medicinal products as defined in Directive 2001/83/EC in their finished state, intended for the final user are not subject to the EU Regulation on the Classification, Labelling and Packaging of on DANGER H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled. H317 May cause an allergic skin reaction. H341 Suspected of causing genetic defects. H351 Suspected of causing cancer. H360DF May damage fertility or the unborn child. H412 Harmful to aquatic life with long lasting effects.
Prevention
P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P261 Avoid breathing dust. P272 Contaminated clothing must not be allowed out of the workplace. P273 Avoid release to the environment. P280 Wear protective gloves and eye protection. P284 In case of inadequate ventilation wear respiratory protection.
Response
P302+P352 IF ON SKIN: Wash with plenty of soap and water. P333+P313 If skin irritation or rash occurs: Get medical attention. P362+P364 Take off contaminated clothing and wash it before reuse. P304+P340 IF INHALED: remove person to fresh air and keep comfortable for breathing. P342+P311 If experiencing respiratory symptoms: Call a POISON CENTER or doctor. P308+P313 If exposed or concerned: Get medical advice.
Storage
Store locked up.
Disposal
Dispose of container and contents as pharmaceutical waste is accordance with national and local regulations. 1) (ver: AM
2.3 Other hazards
None UTC 00005354 Skin Irritation Category 2 (H315)