innohep- tinzaparin sodium injection

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

tinzaparin sodium (UNII: 3S182ET3UA) (tinzaparin - UNII:7UQ7X4Y489)

Disponibil de la:

Celgene Corporation

INN (nume internaţional):

tinzaparin sodium

Forma farmaceutică:

INJECTION

Compoziție:

20000 [iU] in 1 mL

Calea de administrare:

SUBCUTANEOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

INNOHEP® is indicated for the treatment of acute symptomatic deep vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium. The safety and effectiveness of INNOHEP® were established in hospitalized patients. INNOHEP® is contraindicated in patients with active major bleeding, in patients with (or history of) heparin-induced thrombocytopenia, or in patients with hypersensitivity to tinzaparin sodium. INNOHEP® is contraindicated in patients aged 90 years or older with creatinine clearance ≤ 60 mL/min. Patients with known hypersensitivity to heparin, sulfites, benzyl alcohol, or pork products should not be treated with INNOHEP®.

Rezumat produs:

INNOHEP® is available in a multiple dose 2 mL vial in the following packages: Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F) [See USP Controlled Room Temperature]. Keep out of the reach of children. MANUFACTURED FOR: Celgene Corporation Boulder, CO 80301 MANUFACTURED BY: LEO Pharmaceutical Products DK-2750 Ballerup, Denmark Innohep® is a registered trademark of LEO Pharmaceutical Products.

Caracteristicilor produsului

INNOHEP- TINZAPARIN SODIUM INJECTION
CELGENE CORPORATION
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INNOHEP®
(TINZAPARIN SODIUM INJECTION)
FOR SUBCUTANEOUS (SC) USE ONLY
SPINAL/EPIDURAL HEMATOMAS
WHEN NEURAXIAL ANESTHESIA (EPIDURAL/SPINAL ANESTHESIA) OR SPINAL
PUNCTURE IS EMPLOYED,
PATIENTS ANTICOAGULATED OR SCHEDULED TO BE ANTICOAGULATED WITH LOW
MOLECULAR WEIGHT
HEPARINS OR HEPARINOIDS FOR PREVENTION OF THROMBOEMBOLIC COMPLICATIONS
ARE AT RISK OF
DEVELOPING AN EPIDURAL OR SPINAL HEMATOMA WHICH CAN RESULT IN
LONG-TERM OR PERMANENT
PARALYS IS .
THE RISK OF THESE EVENTS IS INCREASED BY THE USE OF INDWELLING
EPIDURAL CATHETERS FOR
ADMINISTRATION OF ANALGESIA OR BY THE CONCOMITANT USE OF DRUGS
AFFECTING HEMOSTASIS SUCH AS
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), PLATELET INHIBITORS,
OR OTHER
ANTICOAGULANTS. THE RISK ALSO APPEARS TO BE INCREASED BY TRAUMATIC OR
REPEATED EPIDURAL OR
SPINAL PUNCTURE.
PATIENTS SHOULD BE FREQUENTLY MONITORED FOR SIGNS AND SYMPTOMS OF
NEUROLOGICAL
IMPAIRMENT. IF NEUROLOGICAL COMPROMISE IS NOTED, URGENT TREATMENT IS
NECESSARY.
THE PHYSICIAN SHOULD CONSIDER THE POTENTIAL BENEFIT VERSUS RISK BEFORE
NEURAXIAL
INTERVENTION IN PATIENTS ANTICOAGULATED OR TO BE ANTICOAGULATED FOR
THROMBOPROPHYLAXIS (SEE
ALSO WARNINGS, HEMORRHAGE, AND PRECAUTIONS, DRUG INTERACTIONS).
DESCRIPTION
INNOHEP® is a sterile solution, containing tinzaparin sodium, a low
molecular weight heparin. It is
available in a multiple dose 2 mL vial.
Each 2 mL vial contains 20,000 anti-Factor Xa IU (anti-Xa) of
tinzaparin sodium per mL, for a total of
40,000 IU, and 3.1 mg/mL sodium metabisulfite as a stabilizer. The
vial contains 10 mg/mL benzyl
alcohol as a preservative. Sodium hydroxide may be added to achieve a
pH range of 5.0 to 7.5.
TABLE 1 COMPOSITION OF 20,000 ANTI-XA IU/ML INNOHEP® (TINZAPARIN
SODIUM INJECTION)
COMPONENT
QUANTITY PER ML
Corresponding to 3.4 mg/mL sodium bisulfite
Tinzaparin sodium
20,000 anti-Xa IU
Benzyl alcohol, USP
10 mg
Sodium metabisulfite, USP
3.106 mg
Sodium hydroxide, USP
as necessary
Water for Injection, USP
q.s. to 1