ENTOCORT CAPSULE (SUSTAINED-RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

BUDESONIDE

Dostopno od:

TILLOTTS PHARMA GMBH

Koda artikla:

A07EA06

INN (mednarodno ime):

BUDESONIDE

Odmerek:

3MG

Farmacevtska oblika:

CAPSULE (SUSTAINED-RELEASE)

Sestava:

BUDESONIDE 3MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

ADRENALS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2000-02-08

Lastnosti izdelka

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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
_ _
_ _
_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
.............................................................................................................
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
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