Note: Ingredients listed on restricted chemical lists
EC/CAS
232-674-9/9004-34-6
Name of the chemical
cellulose
Concentration
N/A
EC/CAS
9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
General Information
Version
05
Revision date
2021-12-09
Product name
TRIUMEQ TABLETS
Product Synonyms
TRELAVUE * DOLUTEGRAVIR, ABACAVIR, LAMIVUDINE FIXED DOSE COMBINATION TABLETS * DOLUTEGRAVIR, ABACAVIR, LAMIVUDINE FDC TABLETS * DOLUTEGRAVIR 50MG, ABACAVIR 600MG, LAMIVUDINE 300MG FIXED DOSE COMBINATION TABLETS * DOLUTEGRAVIR, ABACAVIR, LAMIVUDINE, FORMULATED PRODUCT
Icons in SDS
Company Information
company name
GlaxoSmithKline UK
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)
H341, H350, H373, H411
Hazard statements
Code
Statements
H341
Suspected of causing genetic defects
Section 2
SECTION 2: Hazards identification
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. Classification according to Regulation (EC) No 1272/2008 as amended Health hazards Germ cell mutagenicity Category 2 H341 - Suspected of causing genetic defects. Carcinogenicity Category 1B H350 - May cause cancer. 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 2 H411 - Toxic to aquatic life with long-term aquatic hazard long lasting effects. Hazard summary May cause damage to organs through prolonged or repeated exposure. May cause cancer. Suspected of causing genetic defects. Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards. Dangerous for the environment if discharged into watercourses.
Health hazards
Germ cell mutagenicity Category 2 H341 - Suspected of causing genetic defects. Carcinogenicity Category 1B H350 - May cause cancer. 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 2 H411 - Toxic to aquatic life with long-term aquatic hazard long lasting effects. Hazard summary May cause damage to organs through prolonged or repeated exposure. May cause cancer. Suspected of causing genetic defects. Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards. Dangerous for the environment if discharged into watercourses.
Contains
ABACAVIR HEMISULPHATE, LAMIVUDINE, MICROCRYSTALLINE CELLULOSE
Signal word
Danger
Hazard statements
H341 Suspected of causing genetic defects. H350 May cause cancer. H373 May cause damage to organs through prolonged or repeated exposure. H411 Toxic 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/fume/gas/mist/vapours/spray. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection.
Response
P308 + P313 IF exposed or concerned: Get medical advice/attention. P391 Collect spillage.
Storage
P405 Store locked up.
Disposal
Not available.
Supplemental label elements
21 % of the mixture consists of component(s) of unknown acute oral toxicity. 92 % of the mixture consists of component(s) of unknown acute dermal toxicity. 71 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 28 % of the mixture consists of component(s) of unknown long-term hazards to the aquatic environment. EUH208 - Contains ABACAVIR HEMISULPHATE. May produce an allergic reaction.
2.3 Other hazards
Caution - Pharmaceutical agent. See section 11 of the SDS for additional information on health hazards.
