Enoxaparin Sodium Injection

Fresenius Kabi USA, LLC

Revision date : 2014-11-25

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

100-51-6

Name of the chemical

Benzyl Alcohol

Concentration

N/A

EC/CAS

7732-18-5

Name of the chemical

Water, distilled, conductivity or of similar purity H2O

Concentration

N/A

General Information

Revision date

2014-11-25

Product name

Enoxaparin Sodium Injection

Manufacturer Name

Sanofi-aventis U.S

Icons in SDS

Company Information

company name

Fresenius Kabi USA, LLC

Section 2

SECTION 2: Hazards identification

Emergency Overview: This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert.

Principle Routes of Exposure

Inhalation Ingestion Eye contact Skin Absorption. Injection.

Potential health effects

Eye: Contact with eyes may cause irritation. Skin: May cause skin irritation. Inhalation: May cause irritation of respiratory tract. Ingestion: May cause irritation. Signs/Symptoms: Adverse reactions from prescribed doses include: fever, hemorrhage, nausea, hypochromic anemia, thrombocytopenia, edema and peripheral edema. The incidence of hemorrhagic complications during Enoxaparin sodium injection treatment has been low. During clinical trials with Enoxaparin sodium injection, moderate thrombocytopenia, defined as a platelet count between 100,000/mm3 and 50,000/mm3 occurred at a rate of 1.9% in patients given Enoxaparin sodium, 2.0% in patients given heparin, and 1.7% in patients given placebo following hip or knee replacement surgery. Other adverse effects that were thought to be possibly or probably related to treatment with Enoxaparin sodium injection, heparin or placebo in clinical trials with patients undergoing hip or knee replacement surgery, and that occurred at a rate of at least 2% in the enoxaparin group, are fever, hemorrhage, nausea, hypochromic anemia, edema and peripheral edema.

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