ORFADIN CAPSULE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

NITISINONE

Disponible des:

SWEDISH ORPHAN BIOVITRUM AB (PUBL)

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:

2016-12-13

Fitxa tècnica

_ _
_ _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ORFADIN
nitisinone
2 mg, 5 mg, 10 mg and 20 mg Capsules
4 mg/ml Oral suspension
ATC CODE: A16AX04
Various alimentary tract and metabolism products
Swedish Orphan Biovitrum AB (publ)
SE-112 76
Stockholm, Sweden
www.sobi.com
Date of Preparation:
October 11, 2018
Imported and distributed by:
C.R.I.
4 Innovation Drive,
Dundas, Ontario
L9H 7P3, Canada
Submission Control No: 215784
_ _
_ _
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
......................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
...