ENTOCORT CAPSULE (SUSTAINED-RELEASE)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

BUDESONIDE

Tilgjengelig fra:

TILLOTTS PHARMA GMBH

ATC-kode:

A07EA06

INN (International Name):

BUDESONIDE

Dosering :

3MG

Legemiddelform:

CAPSULE (SUSTAINED-RELEASE)

Sammensetning:

BUDESONIDE 3MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

ADRENALS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2000-02-08

Preparatomtale

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_ENTOCORT_
_® _
_(Budesonide Controlled Ileal Release Capsules) _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ENTOCORT®
Budesonide Controlled Ileal Release Capsules
Capsule (sustained-release), 3 mg, Oral use
Glucocorticosteroid
Tillotts Pharma GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany
Date of Initial Authorization:
AUG 15, 1996
Date of Revision:
MAR 09, 2023
Importer/Distributor:
C.R.I.
Burlington, ON
L7N 3G2
Submission Control Number: 268608
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_ENTOCORT_
_® _
_(Budesonide Controlled Ileal Release Capsules) _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS, Hypersensitivity
03/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
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4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 4
4.4
Administration
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