TELZIR / LEXIVA TABLETS

ViiV Healthcare Limited

Revision date : 2021-07-29

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GHS08
Health risk rating 4
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

<1

EC/CAS

236-675-5/13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

<1 23-<25

General Information

Revision date

2021-07-29

Product name

TELZIR / LEXIVA TABLETS

Product Synonyms

LEXIVA 700 MG TABLETS (US) * TELZIR 700 MG TABLETS * FOSAMPRENAVIR CALCIUM 700

Emergency telephone

VERISK 3E GLOBAL INCIDENT RESPONSE

Icons in SDS

GHS08

Company Information

company name

ViiV Healthcare Limited

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

msds@gsk.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H351, H361, H362, H373

Hazard statements

Code

Statements

H351

Suspected of causing cancer

Section 2

2.1 Classification of the substance or mixture

The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies.

EU Classification

Regulation (EC) No 1272/2008 as amended

Health hazards

Carcinogenicity Category 2 H351 - Suspected of causing cancer. Reproductive toxicity Category 2 H361 - Suspected of damaging fertility or the unborn child. Reproductive toxicity Effects on or via lactation H362 - May cause harm to breast-fed children. Specific target organ toxicity - repeated Category 2 (liver) H373 - May cause damage to exposure organs (liver) through prolonged or repeated exposure. Hazard summary Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.

2.2 Label elements

Label according to Regulation (EC) No. 1272/2008 as amended

Contains

FOSAMPRENAVIR CALCIUM, Titanium dioxide

Signal word

Warning

Hazard statements

H351 Suspected of causing cancer. H361 Suspected of damaging fertility or the unborn child. H362 May cause harm to breast-fed children. H373 May cause damage to organs (liver) through prolonged or repeated exposure.

Prevention

P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust/fume/gas/mist/vapours/spray. P263 Avoid contact during pregnancy and while nursing. P264 Wash thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.

Response

P308 + P313 IF exposed or concerned: Get medical advice/attention.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

Supplemental label elements

18.065 % of the mixture consists of component(s) of unknown acute oral toxicity. 98.565 % of the mixture consists of component(s) of unknown acute dermal toxicity. 98.565 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 95.665 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment.

2.3 Other hazards

Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.

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