Bivalirudin for Injection

Fresenius Kabi USA, LLC

Revision date : 2024-02-13

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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

1310-73-2

Name of the chemical

sodium hydroxide

Concentration

N/A

EC/CAS

69-65-8

Name of the chemical

D-mannitol C6H14O6

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

Version

02/13/2024

Revision date

2024-02-13

Product name

Bivalirudin for Injection

Product name

Bivalirudin for Injection

Identification on the label/Trade name

Bivalirudin for Injection | Manufacturer Fresenius Kabi USA LLC

Manufacturer Name

Fresenius Kabi USA, LLC

Icons in SDS

M004 M009 M010 M011 M013 M017 M026 M059

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 Potential adverse reactions from prescribed doses and overdoses are described in the package insert. Adverse reactions from therapeutic doses include: headache, nausea, backpain, hypertension/hypotension and fatigue. There is no experience to date with deliberate overdosage. Occupational exposure has not been fully investigated.

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