MDK-NITISINONE CAPSULE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

NITISINONE

থেকে পাওয়া:

MENDELIKABS INC

এটিসি কোড:

A16AX04

INN (আন্তর্জাতিক নাম):

NITISINONE

ডোজ:

2MG

ফার্মাসিউটিকাল ফর্ম:

CAPSULE

রচনা:

NITISINONE 2MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

60

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0158450001; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2016-09-20

পণ্য বৈশিষ্ট্য

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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