HEPARIN SODIUM- heparin sodium injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Fresenius Kabi USA, LLC

INN (Nome Internazionale):

Heparin Sodium

Composizione:

Heparin 5000 [USP'U] in 1 mL

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Heparin Sodium Injection is indicated for: - Prophylaxis and treatment of venous thrombosis and pulmonary embolism; - Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; - Atrial fibrillation with embolization; - Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); - Prevention of clotting in arterial and cardiac surgery; - Prophylaxis and treatment of peripheral arterial embolism. - Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. The use of Heparin Sodium Injection is contraindicated in patients with the following conditions: - History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see Warnings and Precautions (5.3)] ; - Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Adverse Reactions

Dettagli prodotto:

Heparin Sodium Injection, USP preservative-free is available as: Discard unused portion Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from freezing. Do not place syringe on a sterile field.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

HEPARIN SODIUM - HEPARIN SODIUM INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPARIN SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
HEPARIN SODIUM
INJECTION.
HEPARIN SODIUM INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
HEPARIN SODIUM INJECTION is an anticoagulant indicated for (1)
Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prevention of postoperative deep venous thrombosis and pulmonary
embolism in patients undergoing
major abdominothoracic surgery or who, for other reasons, are at risk
of developing thromboembolic
disease
Atrial fibrillation with embolization
Treatment of acute and chronic consumptive coagulopathies
(disseminated intravascular coagulation)
Prevention of clotting in arterial and cardiac surgery
Prophylaxis and treatment of peripheral arterial embolism
Use as an anticoagulant in blood transfusions, extracorporeal
circulation, and dialysis procedures
DOSAGE AND ADMINISTRATION
Recommended Adult Dosages:
Therapeutic Anticoagulant Effect with Full-Dose Heparin (2.4)
Based on 150 lb (68 kg) patient. Adjust dose based on laboratory
monitoring.
Deep Subcutaneous (Intrafat)
Injection _Use a different site for_
_each injection_
Initial Dose
5,000 units by intravenous injection,
followed by 10,000 to 20,000 units of a
concentrated solution, subcutaneously
Every 8 hours or
Every 12 hours
8,000 to 10,000 units of a concentrated
solution
15,000 to 20,000 units of a concentrated
solution
Intermittent Intravenous Injection
Initial dose
10,000 units, either
undiluted or in 50 to 100 mL of 0.9%
Sodium Chloride Injection, USP
Every 4 to 6 hours
5,000 to 10,000 units, either undiluted or in
50 to 100 mL of 0.9% Sodium Chloride
Injection, USP
Intravenous Infusion
Initial dose
5,000 units by intravenous injection
Continuous
20,000 to 40,000 units/24 hours in 1000
mL of 0.9% Sodium Chloride Injection