TEFLARO (Ceftaroline Fosamil) Injection for Intravenous Use

ACTAVIS, INC

Revision date : 2015-01-05

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General Information

Revision date

2015-01-05

Product name

TEFLARO (Ceftaroline Fosamil) Injection for Intravenous Use

1.2.1 Relevant identified uses

OTHER DESIGNATIONS NDC 0456-0400-01 400 mg, 10 in 1 carton; NDC 0456-0400-10 400 mg, 20 mL in Single Use Vial; NDC 0456-0600-01 600 mg, 10 in 1 carton; NDC 0456-0600-10 600 mg, 20 mL in Single Use Vial

1.2.2. Uses advised against

Non-Pharmaceutical Use

Emergency telephone

(U.S./NORTH AMERICA

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Company Information

company name

ACTAVIS, INC

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

SDS@Actavis.com

Section 2

SECTION 2: Hazards identification

67/548/EEC EU CLP REGULATION (EC)

Health hazards

Inhalation may cause irritation. Eye contact may cause mechanical irritation. In therapeutic use, the most common adverse effects reported have included diarrhea, nausea, and rash. Chronic ingestion exposure can result in super-infections and overgrowth of flora and yeast, which may range in severity from mild diarrhea to fatal colitis. Serious anaphylactic reactions and drug-induced hemolytic anemia have been reported. As a cephalosporin, this material 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. See Section 11 (Toxicological Information) for information on other potential health hazards known from therapeutic use. Flammability Hazards: If heated to high temperatures for a prolonged period, the material may ignite. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds, including carbon, phosphorous, sodium, sulfur and nitrogen oxides. Reactivity Hazards: This material is not normally reactive.

Environmental hazards

Large quantities released to the aquatic and terrestrial environment may have an adverse effect. Emergency Considerations: Emergency responders should wear appropriate protection for the situation to which they respond.

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