Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
CANGRELOR (CANGRELOR TETRASODIUM)
CHIESI FARMACEUTICI S.P.A.
B01AC25
CANGRELOR
50MG
POWDER FOR SOLUTION
CANGRELOR (CANGRELOR TETRASODIUM) 50MG
INTRAVENOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0164401001; AHFS:
APPROVED
2023-01-20
_Product Monograph Master Template _ _Template Date: September 2020 _ _KENGREXAL (cangrelor) _ _Page 1 of 30_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr KENGREXAL® cangrelor 50 mg powder for solution for injection as cangrelor tetrasodium, intravenous use Manufacturer’s Standard Platelet aggregation inhibitors excl. heparin, B01AC25 Sponsor : Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43122 Parma Italy www.chiesi.com Imported by: Methapharm Inc 81 Sinclair Boulevard Brantford, ON N3S 7X6 Canada Date of Initial Authorization: JAN 19, 2023 Submission Control Number: 255032 _Product Monograph Master Template _ _Template Date: September 2020 _ _KENGREXAL (cangrelor) _ _Page 2 of 30_ TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION................................................................................. 4 4.1 Dosing Considerations ....................................................................................... 4 4.2 Recommended Dose and Dosage Adjustment..................................................... 5 4.3 Reconstitution ................................................................................................... 5 4.4 Administration....................... Aqra d-dokument sħiħ