HEPARIN SODIUM IN SODIUM CHLORIDE injection

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

B. Braun Medical Inc.

INN (Tên quốc tế):

HEPARIN SODIUM

Thành phần:

HEPARIN 200 [USP'U] in 100 mL

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Heparin Sodium in 0.9% Sodium Chloride Injection at the concentration of 2 USP units/mL is indicated as an anticoagulant to maintain catheter patency. The use of HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION is contraindicated in patients with the following conditions: - Uncontrollable active bleeding state except when this is due to disseminated intravascular coagulation [see Warnings and Precautions (5.2)] - History of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis (HITT) [see Warnings and Precautions (5.3)] - Severe thrombocytopenia [see Warnings and Precautions (5.3, 5.4)] - Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)] 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 was observed in animal reproduction studies with administration of heparin sodium to pregnant rats and rabbits during organogenesis at doses, approximately 2777 times the recommended human dose (MRHD) for maintenance of catheter patency of heparin [see Data] . In pregnant animals, doses up to 2777 times higher than the human daily dose of heparin resulted in increased resorptions. Consider the benefits and risks of HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION to a pregnant woman and possible risks to the fetus when prescribing HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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. 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. 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 2777 times the human daily dose. The number of early resorptions increased in both species. There was no evidence of teratogenic effects. There is no information regarding the presence of HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION in human milk, the effects on the breastfed infant, 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 infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION and any potential adverse effects on the breastfed infant from HEPARIN SODIUM IN 0.9% 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. There are limited adequate and well-controlled studies in patients 65 years and older. However, a higher incidence of bleeding has been reported in patients over 60 years of age, especially women [see Warnings and Precautions (5.2)] .

Tóm tắt sản phẩm:

Heparin Sodium in 0.9% Sodium Chloride Injection is a clear solution and is supplied sterile and nonpyrogenic in single-dose EXCEL® Containers. The 1,000 mL containers are packaged 12 per case and 500 mL containers are packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

HEPARIN SODIUM IN SODIUM CHLORIDE- HEPARIN SODIUM IN SODIUM
CHLORIDE INJECTION
B. BRAUN MEDICAL INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPARIN SODIUM IN 0.9%
SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION.
HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE INJECTION at the concentration
of 2 USP units/mL is an
anticoagulant indicated for:
• Maintenance of catheter patency (1)
DOSAGE AND ADMINISTRATION
Although the rate of infusion of the 2 USP units/mL formulation is
dependent upon the age, weight, clinical
condition of the patient, and the procedure being employed, the
recommended starting rate is 6 units per
hour by intravenous infusion through an intravenous catheter to
maintain catheter patency. (2.2)
DOSAGE FORMS AND STRENGTHS
Heparin Sodium 1,000 USP units per 500 mL (2 USP units per mL) in 0.9%
Sodium Chloride Injection (3)
Heparin Sodium 2,000 USP units per 1,000 mL (2 USP units per mL) in
0.9% Sodium Chloride
Injection (3)
CONTRAINDICATIONS
Heparin Sodium in Sodium Chloride Injection is contraindicated in
patients with the following conditions: (4)
Uncontrollable active bleeding state, except when this is due to
disseminated intravascular coagulation
(5.2)
History of heparin-induced thrombocytopenia (HIT) or heparin-induced
thrombocytopenia and
thrombosis (HITT) (5.3)
With severe thrombocytopenia (5.3, 5.4)
Known hypersensitivity to heparin or pork products (5.5, 6.1)
WARNINGS AND PRECAUTIONS
Fatal Medication Errors: Confirm choice of correct strength prior to
administration. (5.1)
Hemorrhage: Fatal cases have occurred. Monitor for signs of bleeding
and manage promptly. (5.2)
HIT or HITT: Monitor for signs and symptoms and discontinue if
indicative of HIT or HITT. (5.3)
Thrombocytopenia: Monitor platelet count during therapy; dis