SOTALOL HYDROCHLORIDE TABLET

TEVA

Revision date : 2014-03-13

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

215-691-6/1344-28-1

Name of the chemical

aluminium oxide

Concentration

Proprietary

EC/CAS

232-679-6/9005-25-8

Name of the chemical

Starch

Concentration

Proprietary

EC/CAS

9003-39-8

Name of the chemical

polyvinylpyrrolidone

Concentration

Proprietary

EC/CAS

212-728-8

Name of the chemical

Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate

Concentration

Proprietary

EC/CAS

200-559-2

Name of the chemical

Lactose C12H22O11

Concentration

Proprietary

EC/CAS

209-150-3

Name of the chemical

Aluminium, zinc, magnesium and calcium stearates

Concentration

Proprietary

General Information

Revision date

2014-03-13

Product name

SOTALOL HYDROCHLORIDE TABLET

Chemical name

For Active Ingredient

1.2.2. Uses advised against

Other than Relevant Use

Manufacturer Name

TEVA

Emergency telephone

1-800/424-9300, 01-703-527-3887

Icons in SDS

Company Information

company name

TEVA

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

TevaSDSRequest@tevapharm.com

Section 2

SECTION 2: Hazards identification

Product definition

This product is supplied as odorless, oval, light blue tablets. Health In the workplace, exposure via inhalation and skin contact may cause irritation. Dusts from tablets can cause mechanical irritation to the eyes. Non-therapeutic ingestion may be harmful. In therapeutic use, the most common adverse effects reported include fatigue, abnormal slow heart rate, difficultly breathing, new or more frequent occurrence of pre-existing arrhythmias, lack or loss of strength and energy, weakness, and dizziness. Therapeutic use can cause serious adverse cardiovascular effects. These effects may be possible as a result of workplace exposure. See Section 11 (Toxicological Information) for information on other potential health hazards known from therapeutic use. Flammability Hazards: This product requires substantial pre-heating before ignition occurs. When involved in a fire, this product may decompose and produce irritating vapors and toxic compounds (including aluminum, carbon, magnesium, titanium, sulfur and nitrogen oxides and hydrogen chloride). Reactivity Hazards: This product is not reactive. Environmental Hazards: Release to the environment may have adverse effect. Emergency Recommendations: Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.

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