BIVALIRUDIN MEDI-MARKET 250 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

BIVALIRUDIN AS TRIFLUOROACETATE

Beschikbaar vanaf:

A.L. MEDI-MARKET LTD.

ATC-code:

B01AE06

farmaceutische vorm:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION

Samenstelling:

BIVALIRUDIN AS TRIFLUOROACETATE 250 MG/VIAL

Toedieningsweg:

I.V

Prescription-type:

Required

Geproduceerd door:

HAINAN POLY PHARM CO., LTD., , PEOPLE’S REPUBLIC OF CHINA

Therapeutisch gebied:

BIVALIRUDIN

therapeutische indicaties:

Bivalirudin Medi-Market 250 mg is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.

Autorisatie datum:

2023-01-12

Productkenmerken

NAME OF THE MEDICINAL PRODUCT
Bivalirudin Medi-Market 250 mg
Powder for concentrate for solution for injection/infusion (I.V.)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg bivalirudin (as trifluoroacetate).
For the full list of excipients, see section 11.
1 THERAPEUTIC INDICATIONS
Bivalirudin Medi-Market 250 mg is indicated for use as an
anticoagulant for use in patients undergoing percutaneous
coronary intervention (PCI) including patients with heparin-induced
thrombocytopenia and heparin-induced
thrombocytopenia and thrombosis syndrome.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
Bivalirudin Medi-Market 250 mg has been studied only in patients
receiving concomitant aspirin.
The recommended dose of bivalirudin Medi-Market 250 mg is an
intravenous bolus dose of 0.75 mg/kg, followed
immediately by an infusion of 1.75 mg/kg/h for the duration of the
procedure. Five minutes after the bolus dose has been
administered, an activated clotting time (ACT) should be performed and
an additional bolus of 0.3 mg/kg should be given
if needed.
Extended duration of infusion following PCI at 1.75 mg/kg/h for up to
4 hours post-procedure should be considered in
patients with ST segment elevation MI (STEMI).
2.2 Dose Adjustment in Renal Impairment
Bolus Dose
No reduction in the bolus dose is needed for any degree of renal
impairment.
Maintenance Infusion
In patients with creatinine clearance less than 30 mL/min (by
Cockcroft Gault equation), reduce the infusion rate to 1
mg/kg/h. Monitor anticoagulant status in patients with renal
impairment.
In patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h
_[see Use in Specific Populations (8.6), Clinical _
_Pharmacology (12.3)]_
.
2.3 Instructions for Preparation and Administration
Bivalirudin Medi-Market 250 mg is intended for intravenous bolus
injection and continuous infusion after reconstitution
and dilution.
Preparation Instructions for Bolus Injection and Continuous Infusion
•
To each 250 mg vial, add 5 mL of Sterile Water for Injection.
•