Vyxeos

Jazz Pharmaceuticals, Inc

Revision date : 2017-09-28

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GHS07 GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 3

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)

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