WIXELA INHUB POWDER

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

R03AK06

Designación común internacional (DCI):

SALMETEROL AND FLUTICASONE

Dosis:

250MCG; 50MCG

formulario farmacéutico:

POWDER

Composición:

FLUTICASONE PROPIONATE 250MCG; SALMETEROL (SALMETEROL XINAFOATE) 50MCG

Vía de administración:

INHALATION

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ADRENALS

Resumen del producto:

Active ingredient group (AIG) number: 0238341002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2020-01-22

Ficha técnica

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_Page 1 of 63_
PRODUCT MONOGRAPH
Pr
WIXELA
® INHUB
®
Fluticasone Propionate and Salmeterol Inhalation Powder
100 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate
Salt)
250 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate
Salt)
500 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate
Salt)
USP
Corticosteroid and Bronchodilator for Oral Inhalation
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Approval: January 09, 2020
Submission Control No: 220505
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_Page 2 of 63_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
14
DRUG INTERACTIONS
.................................................................................................
21
DOSAGE AND ADMINISTRATION
.............................................................................
23
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
.........................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
......................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 28
PART II: SCIENTIFIC INFORMATION
.........................