HEPARIN SODIUM IN DEXTROSE- heparin sodium and dextrose injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

HEPARIN SODIUM (UNII: ZZ45AB24CA) (HEPARIN - UNII:T2410KM04A), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Pieejams no:

B. Braun Medical Inc.

SNN (starptautisko nepatentēto nosaukumu):

HEPARIN SODIUM

Kompozīcija:

HEPARIN 4000 [USP'U] in 100 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Heparin Sodium in 5% Dextrose Injection is indicated for: - 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. The use of HEPARIN SODIUM in 5% Dextrose Injection is contraindicated in patients with the following conditions: - History of heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT) [see Warnings and Precautions (5.3)] - Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)] - In whom suitable blood coagulation tests – e.g., the whole blood clotti

Produktu pārskats:

Heparin Sodium in 5% Dextrose Injection is supplied sterile and nonpyrogenic in single-dose EXCEL® Containers 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.]

Autorizācija statuss:

New Drug Application

Produkta apraksts

HEPARIN SODIUM IN DEXTROSE- HEPARIN SODIUM AND DEXTROSE INJECTION
B. BRAUN MEDICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HEPARIN SODIUM IN 5%
DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR HEPARIN
SODIUM IN 5% DEXTROSE INJECTION.
HEPARIN SODIUM IN 5% DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
Heparin sodium is indicated for: (1)
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.
DOSAGE AND ADMINISTRATION
Recommended Adult Dosages:
Therapeutic Anticoagulant Effect with Full-Dose Heparin* (2.3)
Intermittent Intravenous Injection
Initial Dose
10,000 Units
Subsequent Doses
5,000 to 10,000 Units every 4 to 6 hours
Continuous Intravenous Infusion
Initial Dose
5,000 Units by intravenous injection
Continuous
20,000 to 40,000 Units every 24 hours
* Based on 150 lb. (68 kg) patient.
Cardiovascular Surgery (2.5)
Intravascular via Total Body
Perfusion
Initial
Dose
Greater than or equal to 150 units/kg; adjust for longer
procedures
Extracorporeal Dialysis (2.8)
Intravascular via Extracorporeal Dialysis Follow equipment
manufacturer's operating directions carefully.
For pediatric dosing see section 2.4 of full prescribing information.
DOSAGE FORMS AND STRENGTHS
Heparin Sodium 20,000 USP units per 500 mL (40 USP units per mL) in 5%
Dextrose Injection (3)
Heparin Sodium 25,000 USP units per 500 mL (50 USP units per mL) in 5%
Dextrose Injection (3)
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in
5% Dextrose Injection (3)
CONTRAINDICAT