BUDESONIDE CAPSULE (SUSTAINED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUDESONIDE

Available from:

TILLOTTS PHARMA GMBH

ATC code:

A07EA06

INN (International Name):

BUDESONIDE

Dosage:

3MG

Pharmaceutical form:

CAPSULE (SUSTAINED-RELEASE)

Composition:

BUDESONIDE 3MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ADRENALS

Product summary:

Active ingredient group (AIG) number: 0116807006; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-12-12

Summary of Product characteristics

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_BUDESONIDE_
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_Page 1 of 31_
_Product Monograph_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BUDESONIDE
Budesonide Controlled Ileal Release Capsules
Capsules, 3 mg, Oral
Glucocorticosteroid
Tillotts Pharma GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany
Submission Control Number: 261459
Importer/Distributor:
C.R.I.
3455 North Service Road, Unit #400
Burlington, Ontario
L7N 3G2
Date of Initial Authorization:
December
11, 2018
Date of Revision:
March
14, 2022
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_BUDESONIDE_
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_Capsules_
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_Product Monograph _
_Page 2 of 31_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 4
4.4
Administration
..........................................................................................................
5
4.5
Missed Dose
..............................................................................................................
5
5
OVERDOSAGE