MONISTAT 1 VAGINAL OVULE SUPPOSITORY

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

MICONAZOLE NITRATE

Verfügbar ab:

INSIGHT PHARMACEUTICALS, LLC

ATC-Code:

G01AF04

INN (Internationale Bezeichnung):

MICONAZOLE

Dosierung:

1200MG

Darreichungsform:

SUPPOSITORY

Zusammensetzung:

MICONAZOLE NITRATE 1200MG

Verabreichungsweg:

VAGINAL

Einheiten im Paket:

1

Verschreibungstyp:

OTC

Therapiebereich:

AZOLES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0110272005; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2011-11-03

Fachinformation

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_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MONISTAT*1 VAGINAL OVULE
MICONAZOLE NITRATE
VAGINAL OVULE 1200 MG
MONISTAT*1 COMBINATION PACK
MONISTAT*1 VAGINAL OVULE AND MONISTAT*1 DERM CREAM
MICONAZOLE NITRATE
VAGINAL OVULE 1200 MG AND VAGINAL CREAM 2% USP
Antifungal Agent
ATC Code: G01A F04
Insight Pharmaceuticals LLC
660 White Plains Road, Suite 250
Tarrytown, NY 10591, USA
Date of Initial Approval:
Feb 26, 1999
Date of Revision:
Apr 28, 2020
Submission Control No: 235683
*Trademark
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_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
NONE.
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.3
Administration
........................................................................................................
6
4.4
Reconstitution
........................................................................................................
6
4.5
Missed Dose
..........................................................................................................
6
5
OVERDOSAGE
...............