Note: Ingredients listed on restricted chemical lists
EC/CAS
236-675-5/13463-67-7
Name of the chemical
Reaction mass of titanium dioxide and silver chloride
Concentration
0,2-<0 022-006-
EC/CAS
232-674-9/9004-34-6
Name of the chemical
cellulose
Concentration
N/A
General Information
Revision date
2022-09-02
Product name
EPZICOM TABLETS
Product Synonyms
EPZICOM 600 MG/300 MG TABLETS * KIVEXA 600 MG/300 MG TABLETS * ABC/3TC
Emergency telephone
VERISK 3E GLOBAL INCIDENT RESPONSE
Icons in SDS
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)
H341, H351, H361, H373, H412
Hazard statements
Code
Statements
H341
Suspected of causing genetic defects
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
Germ cell mutagenicity Category 2 H341 - Suspected of causing genetic defects. Carcinogenicity Category 2 H351 - Suspected of causing cancer. Reproductive toxicity Category 2 H361 - Suspected of damaging fertility or the unborn child. Specific target organ toxicity - repeated Category 2 H373 - May cause damage to exposure organs through prolonged or repeated exposure.
Environmental hazards
Hazardous to the aquatic environment, Category 3 H412 - Harmful to aquatic life with long-term aquatic hazard long lasting effects.
2.2 Label elements
Label according to Regulation (EC) No. 1272/2008 as amended
Contains
ABACAVIR HEMISULPHATE, LAMIVUDINE, MICROCRYSTALLINE CELLULOSE, Titanium dioxide ABACAVIR HEMISULPHATE. May produce an allergic reaction
Signal word
Warning
Hazard statements
H341 Suspected of causing genetic defects. H351 Suspected of causing cancer. H361 Suspected of damaging fertility or the unborn child. H373 May cause damage to organs through prolonged or repeated exposure. 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. P260 Do not breathe dust. P273 Avoid release to the environment.
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
24,265 % of the mixture consists of component(s) of unknown acute oral toxicity. 98,965 % of the mixture consists of component(s) of unknown acute dermal toxicity. 96,5 % of the mixture consists of component(s) of unknown acute inhalation toxicity. 77,765 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 28,165 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment. EUH208 -
2.3 Other hazards
Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.
