Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
tinzaparin sodium (UNII: 3S182ET3UA) (tinzaparin - UNII:7UQ7X4Y489)
Celgene Corporation
tinzaparin sodium
INJECTION
20000 [iU] in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
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®.
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.
INNOHEP- TINZAPARIN SODIUM INJECTION CELGENE CORPORATION ---------- 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 Soma hati kamili