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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 OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

Do not administer unless solution is clear and...

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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
  • Injection: 2,000 USP units per 1,000 mL (2 units per mL) clear solution in a single-dose...
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4 CONTRAINDICATIONS

The use of HEPARIN SODIUM IN SODIUM CHLORIDE is contraindicated in patients with the following conditions:

    ...
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5 WARNINGS AND PRECAUTIONS

5.1 Hemorrhage

Avoid using heparin in the presence of major bleeding, except when the...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hemorrhage [see

    6.1 Postmarketing Experience

    ...
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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available...

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10 OVERDOSAGE

Bleeding is the chief sign of heparin overdosage.

Neutralization of heparin effect:

When clinical...

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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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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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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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16 HOW SUPPLIED/STORAGE AND HANDLING

Intravenous solutions with heparin sodium are available in single-dose containers as follows:

...
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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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