CEFDINIR for Oral Suspension USP

TEVA

Revision date : 2013-09-24

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

202-859-9/100-51-6

Name of the chemical

Benzyl Alcohol

Concentration

N/A

EC/CAS

232-940-4/9050-36-6

Name of the chemical

Maltodextrin

Concentration

N/A

EC/CAS

232-679-6/9005-25-8

Name of the chemical

Starch

Concentration

N/A

EC/CAS

201-069-1/77-92-9

Name of the chemical

Citric acid

Concentration

N/A

EC/CAS

232-536-8/9000-30-0

Name of the chemical

guar gum

Concentration

N/A

EC/CAS

208-534-8/532-32-1

Name of the chemical

Benzoic acid and its sodium salt

Concentration

N/A

EC/CAS

200-334-9/57-50-1

Name of the chemical

Sucrose, pure C12H22O11

Concentration

N/A

EC/CAS

234-394-2/11138-66-2

Name of the chemical

xanthan gum

Concentration

N/A

EC/CAS

209-150-3

Name of the chemical

Aluminium, zinc, magnesium and calcium stearates

Concentration

N/A

General Information

Revision date

2013-09-24

Product name

CEFDINIR for Oral Suspension USP

Chemical name

For Active Ingredient: (6R,7R)-7-[[(2Z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5- thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

1.2.1 Relevant identified uses

of the PRODUCT

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 a white to off-white, powdered solid with a cherry scent. Health Hazards: In the workplace, exposure via inhalation and skin contact may cause irritation. Eye contact can cause mechanical irritation. In therapeutic use the most common adverse effect has been diarrhea. Indigestion, gastritis, and abdominal pain have also occurred. Some information indicates cephalosporins may cause skin and respiratory sensitization and allergic reactions; no specific information is available. Prolonged therapeutic use may cause super-infections. Cephalosporins can cause severe allergic reaction in persons susceptible to these antibiotics; death has been reported. These effects may be possible as a result of workplace exposure. Refer to Section 11

TOXICOLOGICAL INFORMATION

for additional information on adverse effects. 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 carbon, sodium, silicon, magnesium, sulfur, and nitrogen oxides). Reactivity This product is not reactive.

Environmental hazards

Negligible. Emergency Recommendations Emergency responders must wear personal protective equipment suitable for the situation to which they are responding.

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