BUDESONIDE CAPSULE (SUSTAINED-RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

BUDESONIDE

متاح من:

TILLOTTS PHARMA GMBH

ATC رمز:

A07EA06

INN (الاسم الدولي):

BUDESONIDE

جرعة:

3MG

الشكل الصيدلاني:

CAPSULE (SUSTAINED-RELEASE)

تركيب:

BUDESONIDE 3MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ADRENALS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2018-12-12

خصائص المنتج

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_BUDESONIDE_
_® _
_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
_ _
_ _
_BUDESONIDE_
_ _
_Capsules_
_ _
_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