INCRUSE ELLIPTA

GlaxoSmithKline UK

Revision date : 2022-05-12

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

General Information

Revision date

2022-05-12

Product name

INCRUSE ELLIPTA

Product Synonyms

INCRUSE * ROLUFTA * VANISTO * UMECLIDINIUM BROMIDE, FORMULATED PRODUCT

CAS No.

869113-09-7

Icons in SDS

GHS07

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

Warning

Hazard Codes

Hazard statements (CLP)

H332, H412

Hazard statements

Code

Statements

H332

Harmful if inhaled

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

Acute toxicity, inhalation Category 4 H332 - Harmful if inhaled.

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

UMECLIDINIUM BROMIDE

Signal word

Warning

Hazard statements

H332 Harmful if inhaled. H412 Harmful to aquatic life with long lasting effects.

Prevention

P261 Avoid breathing dust. P271 Use only outdoors or in a well-ventilated area. P273 Avoid release to the environment.

Response

P304 + P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P312 Call a POISON CENTRE/doctor/ if you feel unwell.

Storage

Not available.

Disposal

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

Supplemental label elements

100 % of the mixture consists of component(s) of unknown acute dermal toxicity. 99.5 % of the mixture consists of component(s) of unknown acute inhalation toxicity. 99.5 % of the mixture consists of component(s) of unknown acute hazards to the aquatic environment. 99.5 % 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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