MDK-NITISINONE CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

NITISINONE

から入手可能:

MENDELIKABS INC

ATCコード:

A16AX04

INN（国際名）:

NITISINONE

投薬量:

5MG

医薬品形態:

CAPSULE

構図:

NITISINONE 5MG

投与経路:

ORAL

パッケージ内のユニット:

60

処方タイプ:

Prescription

治療領域:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2016-09-20

製品の特徴

_ _
_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
_ _
_ _
_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