ORKAMBI GRANULES

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

LUMACAFTOR; IVACAFTOR

Disponible depuis:

VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

Code ATC:

R07AX30

DCI (Dénomination commune internationale):

IVACAFTOR AND LUMACAFTOR

Dosage:

100MG; 125MG

forme pharmaceutique:

GRANULES

Composition:

LUMACAFTOR 100MG; IVACAFTOR 125MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

Cystic Fibrosis Transmembrane Conductance Regulator Correctors

Descriptif du produit:

Active ingredient group (AIG) number: 0257771002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2018-12-11

Résumé des caractéristiques du produit

_Pr_
_ORKAMBI_
®
_ (Lumacaftor/Ivacaftor Tablets and Granules)_
_ _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ORKAMBI
®
Lumacaftor / Ivacaftor Tablets 100 mg / 125 mg, Oral
Lumacaftor / Ivacaftor Tablets 200 mg / 125 mg, Oral
Lumacaftor / Ivacaftor Granules 75 mg / 94 mg, Oral
Lumacaftor / Ivacaftor Granules 100 mg / 125 mg, Oral
Lumacaftor / Ivacaftor Granules 150 mg / 188 mg, Oral
Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Corrector
and Potentiator
ATC R07AX30
Vertex Pharmaceuticals (Canada) Incorporated
20 Bay Street, Suite 1520
Toronto, Ontario
M5J 2N8
Date of Initial Authorization:
January 25, 2016
Date of Revision:
April 6, 2023
Submission Control Number: 264825
_Pr_
_ORKAMBI_
®
_ (Lumacaftor/Ivacaftor Tablets and Granules)_
_ _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS 1.1 Pediatrics
04/2023
2 DOSAGE AND ADMINISTRATION 4.1 Dosing Considerations
04/2023
2 DOSAGE AND ADMINISTRATION 4.2 Recommended Dose and
Dosage Adjustment
04/2023
2 DOSAGE AND ADMINISTRATION 4.4 Administration
04/2023
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 ........................................................................
4
4.1
Dosing Considerations