CORTIMENT TABLET (DELAYED AND EXTENDED RELEASE)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

BUDESONIDE

متاح من:

FERRING INC

ATC رمز:

A07EA06

INN (الاسم الدولي):

BUDESONIDE

جرعة:

9MG

الشكل الصيدلاني:

TABLET (DELAYED AND EXTENDED RELEASE)

تركيب:

BUDESONIDE 9MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

20/30/40/50/60/80

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ADRENALS

ملخص المنتج:

Active ingredient group (AIG) number: 0116807012; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2016-06-20

خصائص المنتج

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_CORTIMENT 9mg Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CORTIMENT
® MMX
Budesonide
Delayed and Extended Release Tablets,
9mg
Glucocorticosteroid
Ferring Inc.
200 Yorkland Boulevard, Suite 500
North York, Ontario M2J 5C1
Date of Preparation:
June 17, 2016
Submission Control No:183534
_ _
_CORTIMENT 9mg Page 2 of 25_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
SPECIAL HANDLING INSTRUCTIONS
.......................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL TRIALS
..........................