TRIKAFTA TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

TEZACAFTOR; IVACAFTOR; IVACAFTOR; ELEXACAFTOR

Dostupné z:

VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

ATC kód:

R07AX32

INN (Medzinárodný Name):

IVACAFTOR, TEZACAFTOR AND ELEXACAFTOR

Dávkovanie:

25MG; 37.5MG; 75MG; 50MG

Forma lieku:

TABLET

Zloženie:

TEZACAFTOR 25MG; IVACAFTOR 37.5MG; IVACAFTOR 75MG; ELEXACAFTOR 50MG

Spôsob podávania:

ORAL

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Prehľad produktov:

Active ingredient group (AIG) number: 0462989002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2022-04-20

Súhrn charakteristických

_ _
_ _
_Pr_
_TRIKAFTA_
_®_
_ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets and
granules _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRIKAFTA
®
Elexacaftor 100 mg / Tezacaftor 50 mg / Ivacaftor 75 mg Tablets and
Ivacaftor 150
mg Tablets
Elexacaftor 50 mg / Tezacaftor 25 mg / Ivacaftor 37.5 mg Tablets and
Ivacaftor 75 mg Tablets
Oral
Elexacaftor 100 mg / Tezacaftor 50 mg / Ivacaftor 75 mg Granules and
Ivacaftor 75 mg
Granules
Elexacaftor 80 mg / Tezacaftor 40 mg / Ivacaftor 60 mg Granules and
Ivacaftor 59.5 mg
Granules
Oral
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Corrector
and Potentiator
ATC R07AX32
Vertex Pharmaceuticals (Canada) Incorporated
20 Bay Street, Suite 1520
Toronto, Ontario
M5J 2N8
Date of Initial Authorization:
June 17, 2021
Date of Revision:
October 13, 2023
Submission Control Number: 271750
_ _
_TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets and
granules _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
1 Indications
10/2023
1 Indications, 1.1 Pediatrics
10/2023
4 Dosage and administration, 4.2 Recommended Dose and Dosage
Adjustment
10/2023
4 Dosage and administration, 4.4 Administration
10/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................
2
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
.......