HEPARIN SODIUM injection

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Gland Pharma Limited

INN (International ime):

HEPARIN SODIUM

Sastav:

HEPARIN 5000 [USP'U] in 1 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 Re

Proizvod sažetak:

 Heparin Sodium Injection, USP preserved with benzyl alcohol is available in the following strengths and package sizes in single Dose vial: * Discard unused portion Heparin Sodium Injection, USP preserved with benzyl alcohol is available in the following strengths and package sizes in multiple-dose vials Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

HEPARIN SODIUM - HEPARIN SODIUM INJECTION
GLAND PHARMA LIMITED
----------
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 (2.3)
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
1,000 mL of 0.9% Sodium Chloride
Injection, USP (or in any compatible
solution) for infusion
Based