MDK-NITISINONE CAPSULE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

NITISINONE

Disponible des:

MENDELIKABS INC

Codi ATC:

A16AX04

Designació comuna internacional (DCI):

NITISINONE

Dosis:

2MG

formulario farmacéutico:

CAPSULE

Composición:

NITISINONE 2MG

Vía de administración:

ORAL

Unidades en paquete:

60

tipo de receta:

Prescription

Área terapéutica:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2016-09-20

Fitxa tècnica

_ _
_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