FONDAPARINUX SODIUM injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

FONDAPARINUX SODIUM (UNII: X0Q6N9USOZ) (FONDAPARINUX - UNII:J177FOW5JL)

Доступна с:

Sandoz Inc.

Администрация маршрут:

SUBCUTANEOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 endoc

Обзор продуктов:

Fondaparinux sodium injection, USP is available in the following strengths and package sizes: 2.5 mg fondaparinux sodium injection, USP in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod. NDC 0781-3443-12 2 Single Unit Syringes NDC 0781-3443-95 10 Single Unit Syringes 5 mg fondaparinux sodium injection, USP in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod. NDC 0781-3454-12 2 Single Unit Syringes NDC 0781-3454-95 10 Single Unit Syringes 7.5 mg fondaparinux sodium injection, USP in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod. NDC 0781-3465-12 2 Single Unit Syringes NDC 0781-3465-95 10 Single Unit Syringes 10 mg fondaparinux sodium injection, USP in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with white plunger rod. NDC 0781-3476-12 2 Single Unit Syringes NDC 0781-3476-95 10 Single Unit Syringes Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Discard unused portion. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

FONDAPARINUX SODIUM- FONDAPARINUX SODIUM INJECTION
SANDOZ 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 ADMINISTRATION
For subcutaneous