KALYDECO TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

IVACAFTOR

Dostopno od:

VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

Koda artikla:

R07AX02

INN (mednarodno ime):

IVACAFTOR

Odmerek:

150MG

Farmacevtska oblika:

TABLET

Sestava:

IVACAFTOR 150MG

Pot uporabe:

ORAL

Enote v paketu:

56/60

Tip zastaranja:

Prescription

Terapevtsko območje:

Cystic Fibrosis Transmembrane Conductance Regulator Potentiators

Povzetek izdelek:

Active ingredient group (AIG) number: 0153450001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2012-11-26

Lastnosti izdelka

_ _
_Pr_
_KALYDECO_
_®_
_ (ivacaftor) Tablets and Granules _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
KALYDECO
®
Ivacaftor Tablets
Tablets: 150 mg, Oral
Ivacaftor Granules
Granules: 13.4 mg per packet, 25 mg per packet, 50 mg per packet, and
75 mg per packet,
Oral
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Potentiator
ATC R07AX02
Vertex Pharmaceuticals (Canada) Incorporated
20 Bay Street, Suite 1520
Toronto, Ontario
M5J 2N8
Date of Initial Authorization:
Nov 26, 2012
Date of Revision:
Nov 27, 2023
Submission Control Number: 273575
_ _
_KALYDECO (ivacaftor) Tablets and Granules _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
1 Indications
11/2023
1 Indications, 1.1 Pediatrics
11/2023
4 Dosage and Administration
11/2023
7 Warnings and Precautions
11/2023
7 Warnings and Precautions, 7.1.3 Pediatrics
11/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
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
.................................................................... 4
4.1
Dosing
Considerations................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.........................................