LOVENOX- enoxaparin sodium injection

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

ENOXAPARIN SODIUM

Koostis:

ENOXAPARIN SODIUM 40 mg in 0.4 mL

Manustamisviis:

SUBCUTANEOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Lovenox® 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. Lovenox 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. Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin. Lovenox, when administered con

Toote kokkuvõte:

Lovenox is available in two concentrations [see Tables 26 and 27]: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Do not store the multiple-dose vials for more than 28 days after the first use. Keep out of the reach of children.

Volitamisolek:

New Drug Application

Toote omadused

LOVENOX - ENOXAPARIN SODIUM INJECTION
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOVENOX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LOVENOX.
LOVENOX (ENOXAPARIN SODIUM INJECTION) FOR SUBCUTANEOUS AND INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1993
WARNING: SPINAL/EPIDURAL HEMATOMA
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, OTHER ANTICOAGULANTS
A HISTORY OF TRAUMATIC OR REPEATED EPIDURAL OR SPINAL PUNCTURES
MONITOR PATIENTS FREQUENTLY FOR SIGNS AND SYMPTOMS OF NEUROLOGICAL
IMPAIRMENT. IF NEUROLOGICAL
COMPROMISE IS NOTED, URGENT TREATMENT IS NECESSARY.
CONSIDER THE BENEFITS AND RISKS BEFORE NEURAXIAL INTERVENTION IN
PATIENTS ANTICOAGULATED OR TO BE
ANTICOAGULATED FOR THROMBOPROPHYLAXIS [SEE _WARNINGS AND PRECAUTIONS
(5.1)_ AND _DRUG INTERACTIONS (7)_].
RECENT MAJOR CHANGES
Boxed Warning, Warnings and Precautions (5.1)
(12/2009)
INDICATIONS AND USAGE
Lovenox 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)
Tr