FONDAPARINUX SODIUM injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

fondaparinux sodium (UNII: X0Q6N9USOZ) (fondaparinux - UNII:J177FOW5JL)

متاح من:

Dr. Reddy's Laboratories Inc.

INN (الاسم الدولي):

fondaparinux sodium

تركيب:

fondaparinux sodium 2.5 mg in 0.5 mL

طريقة التعاطي:

SUBCUTANEOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Fondaparinux sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): - in patients undergoing hip fracture surgery, including extended prophylaxis; - in patients undergoing hip replacement surgery; - in patients undergoing knee replacement surgery; - in patients undergoing abdominal surgery who are at risk for thromboembolic complications. Fondaparinux sodium injection is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium. Fondaparinux sodium injection is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital. Fondaparinux sodium injection is contraindicated in the following conditions: - Severe renal impairment (creatinine clearance [CrCl] <30 mL/min). [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)] - Active major bleeding. - Bacterial endocarditis

ملخص المنتج:

Fondaparinux sodium injection is available in the following strengths and package sizes:  2.5 mg fondaparinux sodium in 0.5 mL single dose prefilled syringe, affixed with a 27-gauge x ½-inch needle with a blue plunger rod. 2 Single Unit Syringes                                                NDC 43598-607-02 10 Single Unit Syringes                                              NDC 43598-607-10 5 mg fondaparinux sodium in 0.4 mL single dose prefilled syringe, affixed with a 27-gauge x ½-inch needle with an orange plunger rod. 2 Single Unit Syringes                                                NDC 43598-608-02 10 Single Unit Syringes                                              NDC 43598-608-10 7.5 mg fondaparinux sodium in 0.6 mL single dose prefilled syringe, affixed with a 27-gauge x ½-inch needle with a magenta plunger rod. 2 Single Unit Syringes                                                NDC 43598-609-02 10 Single Unit Syringes                                              NDC 43598-609-10 10 mg fondaparinux sodium in 0.8 mL single dose prefilled syringe, affixed with a 27-gauge x ½-inch needle with a violet plunger rod. 2 Single Unit Syringes                                                NDC 43598-606-02 10 Single Unit Syringes                                              NDC 43598-606-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Pharmacist: Dispense a Patient Information Leaflet with each prescription.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

FONDAPARINUX SODIUM- FONDAPARINUX SODIUM INJECTION
DR. REDDY'S LABORATORIES INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FONDAPARINUX SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FONDAPARINUX
SODIUM INJECTION.
FONDAPARINUX SODIUM INJECTION FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2001
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), heparinoids, or fondaparinux sodium 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, or other anticoagulants
· a history of traumatic or repeated epidural or spinal puncture
· a history of spinal deformity or spinal surgery
Monitor patients frequently for signs and symptoms of neurologic
impairment. If neurologic
compromise is noted, urgent treatment is necessary.
Consider the benefit and risks before neuraxial intervention in
patients anticoagulated or to be
anticoagulated for thromboprophylaxis. [see Warnings and Precautions
(5.1) and Drug Interactions
(7)]
INDICATIONS AND USAGE
Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant)
indicated for:
Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip
fracture surgery (including
extended prophylaxis), hip replacement surgery, knee replacement
surgery, or abdominal surgery.
(1.1)
Treatment of DVT or acute pulmonary embolism (PE) when administered in
conjunction with warfarin.
(1.2, 1.3)
DOSAGE AND ADMINIS