BUDESONIDE CAPSULE (SUSTAINED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

BUDESONIDE

Boleh didapati daripada:

TILLOTTS PHARMA GMBH

Kod ATC:

A07EA06

INN (Nama Antarabangsa):

BUDESONIDE

Dos:

3MG

Borang farmaseutikal:

CAPSULE (SUSTAINED-RELEASE)

Komposisi:

BUDESONIDE 3MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ADRENALS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2018-12-12

Ciri produk

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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
.................................................................................................
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