KENGREXAL POWDER FOR SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

CANGRELOR (CANGRELOR TETRASODIUM)

Fáanlegur frá:

CHIESI FARMACEUTICI S.P.A.

ATC númer:

B01AC25

INN (Alþjóðlegt nafn):

CANGRELOR

Skammtar:

50MG

Lyfjaform:

POWDER FOR SOLUTION

Samsetning:

CANGRELOR (CANGRELOR TETRASODIUM) 50MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Vörulýsing:

Active ingredient group (AIG) number: 0164401001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-01-20

Vara einkenni

_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.......................