KOMBIGLYZE XR TABLETS

ASTRAZENECA PTY LTD

Revision date : 2020-08-12

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

Note: Ingredients listed on restricted chemical lists

EC/CAS

9004-34-6

Name of the chemical

cellulose

Concentration

N/A

EC/CAS

13463-67-7

Name of the chemical

Reaction mass of titanium dioxide and silver chloride

Concentration

N/A

EC/CAS

14807-96-6

Name of the chemical

Talc

Concentration

N/A

General Information

Revision date

2020-08-12

Product name

KOMBIGLYZE XR TABLETS

Product Synonyms

Saxagliptin/Metformin hydrochloride extended release tablets

supplier name

ASTRAZENECA PTY LTD

Emergency telephone

+44 (0) 1235 239 670

Icons in SDS

Company Information

company name

ASTRAZENECA PTY LTD

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

SafetyDataSheets.AlderleyPark@astrazeneca.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H302, H317, H334

Hazard statements

Code

Statements

H302

Harmful if swallowed

Section 2

2.1 Classification of the substance or mixture

Acute toxicity (Oral) Category 4 Respiratory sensitisation Category 1 Skin sensitisation Category 1

Signal word

Danger

Hazard statements

H302 Harmful if swallowed. H317 May cause an allergic skin reaction. H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled.

Prevention

P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray. P264 Wash skin thoroughly after handling. P272 Contaminated work clothing should not be allowed out of the workplace. P280 Wear protective gloves. P285 In case of inadequate ventilation wear respiratory protection.

Response

P301 + P312 + P330 IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you feel unwell. Rinse mouth. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P304 + P341 IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. P333 + P313 If skin irritation or rash occurs: Get medical advice/ attention. P342 + P311 If experiencing respiratory symptoms: Call a POISON CENTER or doctor/ physician.

Disposal

P501 Dispose of contents/ container to an approved waste disposal plant.

Other hazards which do not result in classification

May cause nausea, vomiting, severe abdominal pain and diarrhoea. See Section 11. The product may form flammable dust clouds in air, if dust from crushed tablets is allowed to accumulate.

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