Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
DALTEPARIN SODIUM (UNII: 12M44VTJ7B) (DALTEPARIN - UNII:S79O08V79F)
Pfizer Laboratories Div Pfizer Inc
DALTEPARIN SODIUM
DALTEPARIN SODIUM 2500 [iU] in 0.2 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy [see Clinical Studies (14.1)] . FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): FRAGMIN is indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months [see Clinical Studies (14.5)] . FRAGMIN is indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients 1 month of age and older. FRAGMIN is not indicated for the acute treatment of VTE. FRAGMIN is contraindicated in: Risk Summary Available data from published literature and postmarketing reports have not reported a clear association wit
After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks. Single-dose prefilled syringe* 2,500 IU / 0.2 mL 10 Syringes 0069-0195-02 5,000 IU / 0.2 mL 10 Syringes 0069-0196-02 7,500 IU / 0.3 mL 10 Syringes 0069-0206-02 Single-dose graduated syringe† 10,000 IU / 1 mL 10 Syringes 0069-0217-02 Single-dose prefilled syringe* 12,500 IU / 0.5 mL 10 Syringes 0069-0220-02 15,000 IU / 0.6 mL 10 Syringes 0069-0223-02 18,000 IU / 0.72 mL 10 Syringes 0069-0228-02 Multiple-dose vial 95,000 IU / 3.8 mL (25,000 IU / mL) 3.8 mL vial 0069-0232-01 Single-dose vial 10,000 IU / 4 mL (2,500 IU / mL) 10 vials 0069-0253-10 Store at 20° to 25°C (68° to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Latex Allergy: The needle shield of the prefilled syringe may contain natural rubber latex [see Dosage and Administration (2.7)] .
New Drug Application
FRAGMIN- DALTEPARIN SODIUM INJECTION PFIZER LABORATORIES DIV PFIZER INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FRAGMIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FRAGMIN. FRAGMIN (DALTEPARIN SODIUM) INJECTION, USP, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 1994 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: • • • • • 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 (5.1, 7). INDICATIONS AND USAGE FRAGMIN is a low molecular weight heparin (LMWH) indicated for • • • • • DOSAGE AND ADMINISTRATION INDICATION DOSING REGIMEN Unstable angina and non-Q- wave MI 120 IU/kg subcutaneous every 12 hours (with aspirin) (2.1) DVT prophylaxis in abdominal surgery 2,500 IU subcutaneous once daily or 5,000 IU subcutaneous once daily or 2,500 IU subcutaneous followed by 2,500 IU subcutaneous 12 hours later and then 5,000 IU subcutaneous once daily (2.2) DVT prophylaxis in hip POSTOPERATIVE START – 2,500 IU subcutaneous 4 to 8 hours after surgery, then 5,000 IU subcutaneous once daily, or PREOPERATIVE START – DAY OF SURGERY 2,500 IU subcutaneous 2 hours before surgery followed by 2,500 IU subcutaneous 4 to 8 hours after surgery, then 5,000 ® USE OF INDWELLING EPIDURAL CATHETERS CONCOMITANT USE OF OTHER D Pročitajte cijeli dokument