Biva 250 mg/5 ml
Bivalirudin
Category: IV Injection
Manufacturer: Healthcare Pharmacuticals Ltd.
Price: 10000.0 ৳
250 mg vial
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Related Medicines
Bivalirudin is indicated for:
Anticoagulant in Patients Undergoing PTCA/PCI or PCI with HITS/HITTS
Unstable Angina/Non-ST-Elevation MI (Off-label)
STEMI Undergoing Primary PCI (Off-label)
Heparin-induced Thrombocytopenia
Anti-platelet drugs
Bivalirudin directly inhibits thrombin by specifically binding both to the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin. Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus; thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release. The binding of bivalirudin to thrombin is reversible as thrombin slowly cleaves the bivalirudin-Arg3-Pro4 bond, resulting in recovery of thrombin active site functions.In in vitro studies, bivalirudin inhibited both soluble (free) and clot-bound thrombin, was not neutralized by products of the platelet release reaction, and prolonged the activated partialthromboplastin time (aPTT), thrombin time (TT), and prothrombin time (PT) of normal human plasma in a concentration-dependent manner. The clinical relevance of these findings is unknown.
Co-administration of Bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events.
Bivalirudin is contraindicated in patients with: Active majorbleeding & Hypersensitivity (e.g., anaphylaxis) to Bivalirudin or its components
Bleeding, Body as a Whole: fever,infection, sepsis;
Cardiovascular: hypotension, syncope, vascular anomaly,ventricular fibrillation;
Nervous: cerebral ischemia, confusion, facialparalysis;
Respiratory: lung edema;
Urogenital: kidney failure, oliguria.
Pregnancy Category B. No adequate and well-controlled studies in pregnant women. As animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Bivalirudin is intended for use with aspirin . Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, Bivalirudin and aspirin should be used together during pregnancy only if clearly needed.Nursing Mothers: It is not known whether bivalirudin is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Bivalirudin is administered to a nursing woman.
Bleeding Events: Although most bleeding associated with the use of Bivalirudin in PCI/PTCA occurs at the site of arterial puncture, hemorrhage can occur at any site. An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic event and cessation of Bivalirudin administration. Bivalirudin should be used with caution in patients with disease states associated with an increased risk of bleeding.Coronary Artery Brachy therapy: An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Bivalirudin in gamma brachytherapy. If a decision is made to use Bivalirudin during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels.
Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of Bivalirudin have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were due to failure to adjust the infusion dose of bivalirudin in persons with renal dysfunction including persons on hemodialysis . Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose. In cases of suspected overdosage, discontinue Bivalirudin immediately and monitor the patient closely for signs of bleeding. There is no known antidote to Bivalirudin. Bivalirudin is hemodialyzable
Store at temperature not exceeding 30º C in a dry place. Do not freeze. Keep out of reach of children
Anti-platelet drugs
Bivalirudin directly inhibits thrombin by specifically binding both to the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin. Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus; thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release. The binding of bivalirudin to thrombin is reversible as thrombin slowly cleaves the bivalirudin-Arg3-Pro4 bond, resulting in recovery of thrombin active site functions.In in vitro studies, bivalirudin inhibited both soluble (free) and clot-bound thrombin, was not neutralized by products of the platelet release reaction, and prolonged the activated partialthromboplastin time (aPTT), thrombin time (TT), and prothrombin time (PT) of normal human plasma in a concentration-dependent manner. The clinical relevance of these findings is unknown.
Pregnancy Category B. No adequate and well-controlled studies in pregnant women. As animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Bivalirudin is intended for use with aspirin . Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, Bivalirudin and aspirin should be used together during pregnancy only if clearly needed.Nursing Mothers: It is not known whether bivalirudin is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Bivalirudin is administered to a nursing woman.
Samm Care