FONDAPARINUX SODIUM injection solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Mylan Institutional LLC

INN (nume internaţional):

FONDAPARINUX SODIUM

Compoziție:

FONDAPARINUX SODIUM 2.5 mg in 0.5 mL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

FONDAPARINUX SODIUM- FONDAPARINUX SODIUM INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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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 SOLUTION FOR SUBCUTANEOUS INJECTION
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:
•
•
•
•
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).]_
RECENT MAJOR CHANGES
•
INDICATIONS AND USAGE
Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant)
indicated for:
•
•
DOSAGE AND ADMINISTRATION
•
•
Do not use as intramuscular injection. For subcutaneous use, do not
mix with other injections or infusions.
DOSAGE FORMS AND STRENGTHS
Single-dose, prefilled syringes containing 2.5 mg, 5 mg, 7.5 mg, or 10
mg of fondaparinux sodium. (3)
CONTRAINDICATIONS
Fondaparinux sodium injection is contraindicated in the following
conditions: (4)
•
•
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