ORKAMBI GRANULES

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

LUMACAFTOR; IVACAFTOR

Disponible des:

VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

Codi ATC:

R07AX30

Designació comuna internacional (DCI):

IVACAFTOR AND LUMACAFTOR

Dosis:

100MG; 125MG

formulario farmacéutico:

GRANULES

Composición:

LUMACAFTOR 100MG; IVACAFTOR 125MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

Cystic Fibrosis Transmembrane Conductance Regulator Correctors

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2018-12-11

Fitxa tècnica

_Pr_
_ORKAMBI_
®
_ (Lumacaftor/Ivacaftor Tablets and Granules)_
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_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)_
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_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