Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)
Teva Parenteral Medicines, Inc.
ENOXAPARIN SODIUM
ENOXAPARIN SODIUM 30 mg in 0.3 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
Enoxaparin Sodium Injection USP is available in two concentrations (see Tables 26 and 27): Dosage Unit/Strength* Anti-Xa Activity † Package Size (per carton) Label Color NDC Number Prefilled Syringes ‡ 30 mg/0.3 mL 3000 IU 10 syringes Medium Blue 0703-8530-23 40 mg/0.4 mL 4000 IU 10 syringes Yellow 0703-8540-23 Graduated Prefilled Syringes ‡ 60 mg/0.6 mL 6000 IU 10 syringes Orange 0703-8560-23 80 mg/0.8 mL 8000 IU 10 syringes Brown 0703-8680-23 100 mg/1 mL 10,000 IU 10 syringes Black 0703-8580-23 Dosage Unit/Strength* Anti-Xa Activity † Package Size (per carton) Syringe Label Color NDC Number Graduated Prefilled Syringes ‡ 120 mg/0.8 mL 12,000 IU 10 syringes Purple 0703-8610-23 150 mg/1 mL 15,000 IU 10 syringes Navy Blue 0703-8510-23 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
ENOXAPARIN SODIUM- ENOXAPARIN SODIUM INJECTION, SOLUTION TEVA PARENTERAL MEDICINES, INC. ---------- 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 myoc Izlasiet visu dokumentu