ENOXAPARIN SODIUM injection

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

enoxaparin sodium (UNII: 8NZ41MIK1O) (enoxaparin - UNII:E47C0NF7LV)

Verfügbar ab:

NorthStar Rx LLC

Verabreichungsweg:

SUBCUTANEOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Enoxaparin Sodium Injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): - in patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.1)] - in patients undergoing hip replacement surgery, during and following hospitalization - in patients undergoing knee replacement surgery - in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness Enoxaparin Sodium Injection is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism , when administered in conjunction with warfarin sodium - the outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium Enoxaparin Sodium Injection is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently admin

Produktbesonderheiten:

Enoxaparin Sodium Injection, USP is supplied in two concentrations (see table 26 and 27). * Strength represents the number of milligrams of enoxaparin sodium in Water for Injection. Enoxaparin Sodium Injection, USP 30 mg and 40 mg prefilled syringes, and 60 mg, 80 mg, and 100 mg graduated prefilled syringes each contain 10 mg enoxaparin sodium per 0.1 mL Water for Injection. † Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard. ‡ Each Enoxaparin Sodium Injection, USP prefilled syringe is for single, one-time use only and is affixed with a 27 gauge x 1/2 inch needle. * Strength represents the number of milligrams of enoxaparin sodium in Water for Injection. Enoxaparin Sodium Injection, USP 120 mg and 150 mg graduated prefilled syringes contain 15 mg enoxaparin sodium per 0.1 mL Water for Injection. † Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard. ‡ Each Enoxaparin Sodium Injection, USP graduated prefilled syringe is for single, one-time use only and is affixed with a 27 gauge x 1/2 inch needle. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Store in the original carton or packaging until ready to use. WARNING: Keep out of the reach of children. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container closure is not made with natural rubber latex.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ENOXAPARIN SODIUM- ENOXAPARIN SODIUM INJECTION
NORTHSTAR RX LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENOXAPARIN SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ENOXAPARIN SODIUM
INJECTION.
ENOXAPARIN SODIUM INJECTION, FOR SUBCUTANEOUS AND INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1993
WARNING: SPINAL/EPIDURAL HEMATOMAS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN PATIENTS WHO ARE
ANTICOAGULATED WITH LOW
MOLECULAR WEIGHT HEPARINS (LMWH) OR HEPARINOIDS AND ARE RECEIVING
NEURAXIAL
ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THESE HEMATOMAS MAY RESULT
IN LONG-TERM
OR PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING PATIENTS
FOR SPINAL
PROCEDURES. FACTORS THAT CAN INCREASE THE RISK OF DEVELOPING EPIDURAL
OR SPINAL
HEMATOMAS IN THESE PATIENTS INCLUDE:
USE OF INDWELLING EPIDURAL CATHETERS
CONCOMITANT USE OF OTHER DRUGS THAT AFFECT HEMOSTASIS, SUCH AS
NON-STEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS), PLATELET INHIBITORS, AND OTHER
ANTICOAGULANTS
A HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES
A HISTORY OF SPINAL DEFORMITY OR SPINAL SURGERY
OPTIMAL TIMING BETWEEN THE ADMINISTRATION OF ENOXAPARIN SODIUM
INJECTION AND
NEURAXIAL PROCEDURES IS NOT KNOWN
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL
IMPAIRMENT. IF
NEUROLOGICAL COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY. (5.1,
7)
INDICATIONS AND USAGE
Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH)
indicated for:
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip
replacement surgery, knee
replacement surgery, or medical patients with severely restricted
mobility during acute illness (1.1)
Inpatient treatment of acute DVT with or without pulmonary embolism
(1.2)
Outpatient treatment of acute DVT without pulmonary embolism (1.2)
Prophylaxis of ischemic complications of unstable angina and
non-Q-wave myocardial infarction (MI)
(1.3