ENOXAPARIN SODIUM injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)

Boleh didapati daripada:

Fresenius Kabi USA, LLC

Laluan pentadbiran:

SUBCUTANEOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Enoxaparin sodium 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 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 is indicated for the prophylaxis of ischemic complications

Ringkasan produk:

Enoxaparin sodium injection is available in two concentrations (see Tables 26 and 27). Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. Store in the original carton or packaging until ready to use. Do not store the multiple-dose vials for more than 28 days after the first use.

Status kebenaran:

New Drug Application Authorized Generic

Ciri produk

ENOXAPARIN SODIUM- ENOXAPARIN SODIUM INJECTION
FRESENIUS KABI USA, 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 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 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)
Trea