ZEJULA TABLETS

GlaxoSmithKline US

Revision date : 2021-01-12

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GHS07 GHS09 GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

0.2-<0.9

EC/CAS

25322-68-3

Name of the chemical

polyethyleneglycol

Concentration

0.1-<0.3

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

32.53

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

3.88

General Information

Revision date

2021-01-12

Product name

ZEJULA TABLETS

Product Synonyms

NIRAPARIB TOSYLATE MONOHYDRATE, FORMULATED PRODUCT

Emergency telephone

+1-888-825-5249, +(1) 760 476 3971, +(1) 760 476 3962, +(1) 866 519 4752

Icons in SDS

GHS07 GHS08 GHS09 T050 W001

Company Information

company name

GlaxoSmithKline US

e-mail address of the competent person responsible for the Safety Data Sheet

msds@gsk.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H302, H340, H361, H373, H410

Hazard statements

Code

Statements

H302

Harmful if swallowed

Section 2

SECTION 2: Hazards identification

Physical hazards

Not classified

Health hazards

Acute toxicity, oral Category 4 Germ cell mutagenicity Category 1B Reproductive toxicity Category 2 Specific target organ toxicity, repeated Category 2 exposure

Environmental hazards

Hazardous to the aquatic environment, Category 1

Signal word

Danger

Hazard statements

Harmful if swallowed. May cause genetic defects. Suspected of damaging fertility or the unborn child. May cause damage to organs through prolonged or repeated exposure. Very toxic to aquatic life with long lasting effects.

Prevention

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Do not breathe dust/fume/gas/mist/vapors/spray. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. Avoid release to the environment. Wear protective gloves/protective clothing/eye protection/face protection.

Response

If swallowed: Call a poison center/doctor/physician/ if you feel unwell. Rinse mouth. Immediately call a poison center/doctor/physician. Specific treatment is urgent (see information on this label). Collect spillage.

Storage

Store locked up.

Disposal

Dispose of contents/container in accordance with local/regional/national/international regulations. Hazard(s) not otherwise Caution - Potent pharmaceutical agent. See section 11 of the SDS for additional information on classified (HNOC) health hazards.

Additional information

34.995% of the mixture consists of component(s) of unknown acute oral toxicity. 99.565% of the mixture consists of component(s) of unknown acute dermal toxicity. 49.285% of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.

2.1 Classification of the substance or mixture

Not classified. Health hazards Acute toxicity, oral Category 4 Germ cell mutagenicity Category 1B Reproductive toxicity Category 2 Specific target organ toxicity, repeated Category 2 exposure Environmental hazards Hazardous to the aquatic environment, Category 1 long-term hazard OSHA defined hazards Not classified.

SDS Library

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Up-to-date – Your SDS get updated to latest versions.
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Employee access – Tablets, Smartphones, or link from Corporate Intranet
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Safety – One-click access to first aid information.
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Labels – Generate Secondary Container Labels with just one click.