MDK-NITISINONE CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

NITISINONE

Mevcut itibaren:

MENDELIKABS INC

ATC kodu:

A16AX04

INN (International Adı):

NITISINONE

Doz:

10MG

Farmasötik formu:

CAPSULE

Kompozisyon:

NITISINONE 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

60

Reçete türü:

Prescription

Terapötik alanı:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0158450003; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2016-09-20

Ürün özellikleri

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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