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heparin sodium in 0.9% sodium chloride injection
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heparin sodium in 0.9% sodium chloride injection Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
Heparin Sodium Injection in Sodium Chloride at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
Do not administer unless solution is clear and seal is intact.Parenteral drug products should be...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
- •
- Injection: 1,000 USP units per 500 mL (2 units per mL) clear solution in a single-dose infusion bag
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- Injection: 2,000 USP units per 1,000 mL (2 units per mL) clear solution in a...
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Contraindications
4 CONTRAINDICATIONS
The use of HEPARIN SODIUM IN SODIUM CHLORIDE is contraindicated in patients with the following conditions:
- •
- Uncontrollable active bleeding state, except when this is due to...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hemorrhage
Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
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- Hemorrhage [see Warnings and Precautions (5....
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Oral Anticoagulants
Heparin sodium may prolong the one-stage prothrombin time. Therefore, when heparin sodium is given with dicumarol or...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no...
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Overdosage
10 OVERDOSAGE
Bleeding is the chief sign of heparin overdosage.
Neutralization of heparin effect:
When clinical...
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Description
11 DESCRIPTION
Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. Each 100 mL contains heparin sodium 200 USP Units; sodium...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change,...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term studies in animals have been performed to evaluate carcinogenic...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Intravenous solutions with heparin sodium are available in single-dose containers as follows:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Hemorrhage
Inform patients that it may take them longer than usual to stop bleeding, that they may...
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