BUDESONIDE CAPSULE (SUSTAINED-RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BUDESONIDE

Disponibil de la:

TILLOTTS PHARMA GMBH

Codul ATC:

A07EA06

INN (nume internaţional):

BUDESONIDE

Dozare:

3MG

Forma farmaceutică:

CAPSULE (SUSTAINED-RELEASE)

Compoziție:

BUDESONIDE 3MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ADRENALS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-12-12

Caracteristicilor produsului

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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