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FRAGMIN (dalteparin sodium injection) for Subcutaneous (一)
2016-01-09 08:49:49 来源: 作者: 【 】 浏览:9347次 评论:0

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) for Subcutaneous Use Only
Initial U.S. Approval: 1994
WARNING: SPINAL/EPIDURAL HEMATOMA 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, 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 FRAGMIN 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.

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                                                                                                            1/2015
Risk of Hemorrhage including Spinal / Epidural Hematoma  (5.1)                             1/2015
INDICATIONS AND USAGE
FRAGMIN is a low molecular weight heparin [LMWH] indicated for

Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (1.1)
Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness (1.2)
Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months (1.3)
Limitations of Use
FRAGMIN is not indicated for the acute treatment of VTE.
DOSAGE AND ADMINISTRATION
 Indication        &n

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