AURO-PIRFENIDONE Comprimé

Kraj: Kanada

Język: francuski

Źródło: Health Canada

Składnik aktywny:

Pirfénidone

Dostępny od:

AURO PHARMA INC

Kod ATC:

L04AX05

INN (International Nazwa):

PIRFENIDONE

Dawkowanie:

267MG

Forma farmaceutyczna:

Comprimé

Skład:

Pirfénidone 267MG

Droga podania:

Orale

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Podsumowanie produktu:

Numéro de groupe d'ingrédients actifs (GIA) :0153328001; AHFS:

Status autoryzacji:

APPROUVÉ

Data autoryzacji:

2023-05-12

Charakterystyka produktu

Auro-Pirfenidone
Page 1 of 45
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-PIRFENIDONE
Pirfenidone Tablets
Tablets 267 mg and 801 mg, Oral
Anti-fibrotic/Anti-inflammatory Agent
Auro Pharma Inc.
3700 Steeles Avenue West, Suite #
402, Woodbridge, Ontario, L4L 8K8,
Canada
Date of Preparation:
May 7, 2023
Submission Control Number: 267982
Auro-Pirfenidone
Page 2 of 45
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1 INDICATIONS
......................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2. CONTRAINDICATIONS
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4
3. SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................... 4
4. DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
...............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.......................................................... 5
4.3 Reconstitution
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7
4.4 Administration
......................