MONUROL (Fosfomycin Tromethamine) SACHET

ACTAVIS, INC

Revision date : 2014-12-31

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Health risk rating
Safety risk rating
Environmental risk rating

Note: Ingredients listed on restricted chemical lists

EC/CAS

200-334-9/57-50-1

Name of the chemical

Sucrose, pure C12H22O11

Concentration

N/A

General Information

Revision date

2014-12-31

Product name

MONUROL (Fosfomycin Tromethamine) SACHET

Product Synonyms

NDC 0456-4300-08

supplier name

U.S

Emergency telephone

1-800-424-9300, +1-703-527-3887

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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

Health hazards

Inhalation may cause irritation. Eye contact may cause mechanical irritation. In therapeutic use, the most common adverse effects reported have included diarrhea, headache, vaginitis, nausea, runny nose, back pain, painful cramps, pharyngitis, dizziness, abdominal pain, general pain, upset stomach, lack or loss of strength and energy, weakness, and rash. Therapeutic use may also cause angioedema, aplastic anemia, exacerbation of asthma, cholestatic jaundice, hepatic necrosis, and acute toxic colitis including dilation of the colon. 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. 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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