HEPARIN SODIUM IN SODIUM CHLORIDE- heparin sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A)

Available from:

Baxter Healthcare Corporation

INN (International Name):

HEPARIN SODIUM

Composition:

HEPARIN 200 [USP'U] in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Heparin Sodium in Sodium Chloride Injection at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency. The use of Heparin Sodium in Sodium Chloride Injection is contraindicated in patients with the following conditions: Risk Summary There are no available data on Heparin Sodium in Sodium Chloride Injection use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published reports heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans (see Data) . Consider the benefits and risks of Heparin Sodium in Sodium Chloride Injection for the mother and possible risks to the fetus when prescribing Heparin Sodium in Sodium Chloride Injection to a pregnant woman. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the background ris

Product summary:

Heparin Sodium in Sodium Chloride Injection in VIAFLEX PLUS plastic container is supplied as follows: Product Description Size Code NDC 1,000 USP Heparin Units in Sodium Chloride Injection 500 mL 2B0953 0338-0431-03 1,000 USP Heparin Units in Sodium Chloride Injection 500 mL AHB0953U 0338-0424-18 2,000 USP Heparin Units in Sodium Chloride Injection 1,000 mL 2B0944 0338-0433-04 2,000 USP Heparin Units in Sodium Chloride Injection 1,000 mL AHB0944U 0338-0428-12 Store at 25°C (77°F). Brief exposure up to 40°C (104°F) does not adversely affect the product. Avoid excessive heat.

Authorization status:

New Drug Application

Summary of Product characteristics

HEPARIN SODIUM IN SODIUM CHLORIDE- HEPARIN SODIUM INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
REFERENCE LABEL SET ID: 35C07274-EFFF-4FCC-A075-1645C2E49327
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPARIN SODIUM IN
SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION.
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1939
RECENT MAJOR CHANGES
Dosage and Administration Preparation of Administration (2.1) 01/2022
Warnings and Precautions (5.2, 5.6, 5.7) 01/2022
INDICATIONS AND USAGE
Heparin Sodium in Sodium Chloride Injection at a concentration of 2
units/mL is indicated as an
anticoagulant to maintain catheter patency. (1)
DOSAGE AND ADMINISTRATION
Infuse through intravenous catheter at a rate of 6 units per hour.
(2.2)
DOSAGE FORMS AND STRENGTHS
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•
CONTRAINDICATIONS
Heparin Sodium in Sodium Chloride Injection is contraindicated in
patients with the following conditions: (4)
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
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ADVERSE REACTIONS
Most common adverse reactions are: hemorrhage, thrombocytopenia, HIT
and HITT, hypersensitivity, and
elevations of aminotransferase levels. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAXTER HEALTHCARE AT
1-866-888-2472 OR
FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs that interfere with platelet aggregation or drugs that
counteract coagulation may induce bleeding
(7.2)
USE IN SPECIFIC POPULATIONS
Geriatric Use: A higher incidence of bleeding has been reported in
patients over 60 years of age, especially
women (5.7, 8.5)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2022
Injection: 1,000 USP units in Sodium Chloride in 500 mL single-dose
infusion bag (2 USP units per mL)
(3)
Injection: 2,000 USP units in Sodium Chloride per 1,000 mL single-dose
infusion bag (2 USP units per
mL) (3)
With an uncontrollable active bleeding state, excep