FRAGMIN- dalteparin sodium injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DALTEPARIN SODIUM (UNII: 12M44VTJ7B) (DALTEPARIN - UNII:S79O08V79F)

Available from:

Pfizer Laboratories Div Pfizer Inc

INN (International Name):

DALTEPARIN SODIUM

Composition:

DALTEPARIN SODIUM 2500 [iU] in 0.2 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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)] .

Authorization status:

New Drug Application

Summary of Product characteristics

FRAGMIN- DALTEPARIN SODIUM INJECTION
PFIZER LABORATORIES DIV PFIZER INC
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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