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heparin sodium in 5% dextrose injection 50 units/ml and 100 units/ml
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heparin sodium in 5% dextrose injection 50 units/ml and 100 units/ml Quick Finder
1 INDICATIONS AND USAGE
HEPARIN SODIUM IN 5% DEXTROSE INJECTION is indicated for:
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- Prophylaxis and treatment of venous thrombosis and pulmonary embolism;
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- Prophylaxis and treatment of...
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
Confirm the selection of the correct formulation and strength prior to administration of the drug.
...3 DOSAGE FORMS AND STRENGTHS
HEPARIN SODIUM IN 5% DEXTROSE INJECTION is available as:
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- Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection.
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- Heparin...
4 CONTRAINDICATIONS
The use of heparin sodium is contraindicated in patients:
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- With history of heparin-induced thrombocytopenia (HIT) (With or Without Thrombosis) [see...
5 WARNINGS AND PRECAUTIONS
5.1 Fatal Medication Errors
Do not use this product as a "catheter lock flush" product. Heparin is supplied in various strengths. Fatal...
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
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- Fatal Medication Errors [see Warnings and...
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...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no available...
10 OVERDOSAGE
Symptoms
Bleeding is the chief sign of heparin overdosage. Nosebleeds, blood in urine or tarry stools may be noted as the first...
11 DESCRIPTION
Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies in animals to evaluate the carcinogenic potential, reproduction...
16 HOW SUPPLIED/STORAGE AND HANDLING
Intravenous solutions with heparin sodium are available in single-dose flexible plastic containers in various sizes and concentrations as shown in the accompanying Table as follows:
...17 PATIENT COUNSELING INFORMATION
Hemorrhage
Inform patients that it may take them longer than usual to stop bleeding, that they may bruise...
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