HEPARIN SODIUM injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Hospira, Inc.

ИНН (Международная Имя):

HEPARIN SODIUM

состав:

HEPARIN 10000 [USP'U] in 100 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is indicated for: The use of heparin sodium is contraindicated in patients: Risk Summary There are no available data on HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In published reports, heparin exposure during pregnancy did not show evidence of an increased risk of adverse maternal or fetal outcomes in humans. No teratogenicity, but early embryo-fetal death was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses up to 10,000 USP units/kg/day, approximately 10 times the maximum recommended human dose (MRHD) of 40,000 USP units/24 hours infusion (see Data) . Consider the benefits and risks of HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION to a pregnant woman and possible risks to the fetus when prescribing HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data The maternal and fetal outcomes associated with uses of heparin via various dosing methods and administration routes during pregnancy have been investigated in numerous studies. These studies generally reported normal deliveries with no maternal or fetal bleeding and no other complications. Animal Data In a published study conducted in rats and rabbits, pregnant animals received heparin intravenously during organogenesis at a dose of 10,000 USP units/kg/day, approximately 10 times the maximum human daily dose based on body weight. The number of early resorptions increased in both species. There was no evidence of teratogenic effects. Risk Summary There is no information regarding the presence of HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION in human milk, the effects on the breastfed child, or the effects on milk production. Due to its large molecular weight, heparin is not likely to be excreted in human milk, and any heparin in milk would not be orally absorbed by a nursing child. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION and any potential adverse effects on the breastfed child from HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION or from the underlying maternal condition [see Use in Specific Populations (8.4)] . There are no adequate and well controlled studies on heparin use in pediatric patients. Pediatric dosing recommendations are based on clinical experience [see Dosage and Administration (2.4)] . A higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see Warnings and Precautions (5.2)] . Lower doses of heparin may be indicated in these patients [see Clinical Pharmacology (12.3)] .

Обзор продуктов:

Intravenous solutions with HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION are supplied in single-dose flexible plastic containers in varied sizes and concentrations as shown in the accompanying Table. Unit of Sale Concentration NDC 0409-7650-62 Case of 24 Single-dose flexible plastic containers 25,000 USP units/250 mL (100 USP units/mL) NDC 0409-7650-30 Case of 30 Single-dose flexible plastic containers 25,000 USP units/250 mL (100 USP units/mL) NDC 0409-7651-62 Case of 24 Single-dose flexible plastic containers 12,500 USP units/250 mL (50 USP units/mL) NDC 0409-0012-30 Case of 30 Single-dose flexible plastic containers 12,500 USP units/250 mL (50 USP units/mL) NDC 0409-7651-03 Case of 24 Single-dose flexible plastic containers 25,000 USP units/500 mL (50 USP units/mL) NDC 0409-3150-20 Case of 20 Single-dose flexible plastic containers 25,000 USP units/500 mL (50 USP units/mL) Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

Статус Авторизация:

New Drug Application

Характеристики продукта

HEPARIN SODIUM- HEPARIN SODIUM INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPARIN SODIUM IN
SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION.
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
HEPARIN SODIUM IN SODIUM CHLORIDE INJECTION is indicated for: (1)
•
•
•
•
•
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DOSAGE AND ADMINISTRATION
Recommended Adult Dosages:
•
Intermittent Intravenous
Injection
Initial Dose
10,000 Units
Every 4 to 6 hours
5,000 Units to 10,000 Units
Continuous Intravenous Infusion
Initial Dose
5,000 Units
Continuous
20,000 Units to 40,000 Units/24 hours
*Based on 150 lb (68 kg) patient.
•
Intravascular via Total Body
Perfusion
Initial Dose
Not less than 150 units/kg; adjust for
longer procedures
•
For pediatric dosing see section 2.4 of full prescribing information.
Intravascular via Extracorporeal
Dialysis
Follow equipment manufacturer's operating directions carefully.
DOSAGE FORMS AND STRENGTHS
Heparin sodium is available as: (3)
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•
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CONTRAINDICATIONS
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Prophylaxis and treatment of venous thrombosis and pulmonary embolism
Prophylaxis and treatment of thromboembolic complications associated
with atrial fibrillation
Treatment of acute and chronic consumption 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
Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)
Cardiovascular Surgery (2.5)
Extracorporeal Dialysis (2.8)
Injection: 100 USP Units/mL in Sodium Chloride clear solution (25,000
USP Units/250 mL) in single-
dose flexible plastic container
Injection: 50 USP Units/mL in Sodium Chloride clear solution (12,500
USP Units/250 mL