MONICURE CAPSULE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

FLUCONAZOLE

Saadav alates:

INSIGHT PHARMACEUTICALS, LLC

ATC kood:

J02AC01

INN (Rahvusvaheline Nimetus):

FLUCONAZOLE

Annus:

150MG

Ravimvorm:

CAPSULE

Koostis:

FLUCONAZOLE 150MG

Manustamisviis:

ORAL

Ühikuid pakis:

1

Retsepti tüüp:

OTC

Terapeutiline ala:

AZOLES

Toote kokkuvõte:

Active ingredient group (AIG) number: 0122529004; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2012-02-10

Toote omadused

PRODUCT MONOGRAPH
MONICURE™
FLUCONAZOLE CAPSULE 150 MG MONICURE™ COMBO
FLUCONAZOLE CAPSULE 150 MG AND MICONAZOLE NITRATE CREAM USP 2%
ANTIFUNGAL AGENT
INSIGHT PHARMACEUTICALS, LLC
660 WHITE PLAINS ROAD
TARRYTOWN, NY USA
10591
DATE OF REVISION:
July 10,
2019
Submission Control No: 224641, 224642.
_Page 2 of 44_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................................
3
CONTRAINDICATIONS
.................................................................................................................
3
WARNINGS AND PRECAUTIONS
...............................................................................................
4
ADVERSE REACTIONS
.................................................................................................................
6
DRUG INTERACTIONS
.................................................................................................................
7
DOSAGE AND ADMINISTRATION
............................................................................................
11
OVERDOSAGE
..............................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
13
STORAGE AND STABILITY
.......................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 15
PART II: SCIENTIFIC INFORMATION
................................................................................
16
PHARMACEUTICAL INFORMATION
.......................................................................................
16
CLINICAL