MDK-NITISINONE CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

NITISINONE

متاح من:

MENDELIKABS INC

ATC رمز:

A16AX04

INN (الاسم الدولي):

NITISINONE

جرعة:

5MG

الشكل الصيدلاني:

CAPSULE

تركيب:

NITISINONE 5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

60

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

ملخص المنتج:

Active ingredient group (AIG) number: 0158450002; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2016-09-20

خصائص المنتج

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_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MDK-NITISINONE
Nitisinone capsules
Capsules, 2 mg, 5 mg, 10 mg and 20 mg
ATC CODE: A16AX04
Various alimentary tract and metabolism products
MendeliKABS Inc
4601, rue de Tonnancour
Saint-Hubert (Quebec)
Canada, J3Y 9J3
Date of Revision:
November 29, 2017
Submission Control No: 202740
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_Page 2 of 21_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................................15
CLINICAL