HEPARIN SODIUM injection HEPARIN SODIUM injection

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Hikma Pharmaceuticals USA Inc.

INN (Међународно име):

HEPARIN SODIUM

Састав:

HEPARIN 1000 [USP'U] in 1 mL

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

Heparin Sodium Injection preserved with benzyl alcohol is available in the following strengths and package sizes in single-dose vials: DESCRIPTION NDC 1,000 USP units/mL    25 vials: 1,000 USP units/mL, single-dose* 0641-0391-12 5,000 USP units/mL    25 vials: 5,000 USP units/mL, single-dose* 0641-0400-12 10,000 USP units/mL    25 vials: 10,000 USP units/mL, single-dose* 0641-0410-12 *Discard unused portion Heparin Sodium Injection preserved with benzyl alcohol is available in the following strengths and package sizes in multiple-dose vials: DESCRIPTION NDC 1,000 USP units/mL   1 vial: 30,000 USP units/30 mL, multiple-dose    25 vials: 30,000 USP units/30 mL, multiple-dose 0641-2450-55 5,000 USP units/mL   1 vial: 50,000 USP units/10 mL, multiple-dose    25 vials: 50,000 USP units/10 mL, multiple-dose 0641-2460-55 Heparin Sodium Injection preservative-free is available in the following strengths and package sizes in single-dose prefilled syringes: DESCRIPTION NDC 5,000 USP units/mL 1 Syringe: 5,000 USP units/mL, single-dose* 0641-6199-01 10 Syringes: 5,000 USP units/mL, single-dose* 0641-6199-10 *Discard unused portion Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Статус ауторизације:

New Drug Application

Карактеристике производа

HEPARIN SODIUM- HEPARIN SODIUM INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
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)
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, USP (or in any compatible solution) for infusion
Based on 150 lb (68 kg) patien