HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
heparin sodium in 0.9% sodium chloride injection
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
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.
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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
- •
- Injection: 2,000 USP units per 1,000 mL (2 units per mL) clear solution in a...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- •
- Hemorrhage [see Warnings and Precautions (5....
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no...
Did you find an answer to your question?
Yes
No
Overdosage
10 OVERDOSAGE
Bleeding is the chief sign of heparin overdosage.
Neutralization of heparin effect:
When clinical...
Did you find an answer to your question?
Yes
No
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...
Did you find an answer to your question?
Yes
No
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,...
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No long term studies in animals have been performed to evaluate carcinogenic...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Intravenous solutions with heparin sodium are available in single-dose containers as follows:
Did you find an answer to your question?
Yes
No
Medication Guide
17 PATIENT COUNSELING INFORMATION
Hemorrhage
Inform patients that it may take them longer than usual to stop bleeding, that they may...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.