MDK-NITISINONE CAPSULE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

NITISINONE

Saadav alates:

MENDELIKABS INC

ATC kood:

A16AX04

INN (Rahvusvaheline Nimetus):

NITISINONE

Annus:

5MG

Ravimvorm:

CAPSULE

Koostis:

NITISINONE 5MG

Manustamisviis:

ORAL

Ühikuid pakis:

60

Retsepti tüüp:

Prescription

Terapeutiline ala:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2016-09-20

Toote omadused

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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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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