MONISTAT DERM CREAM

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

MICONAZOLE NITRATE

Fáanlegur frá:

INSIGHT PHARMACEUTICALS, LLC

ATC númer:

D01AC02

INN (Alþjóðlegt nafn):

MICONAZOLE

Skammtar:

2%

Lyfjaform:

CREAM

Samsetning:

MICONAZOLE NITRATE 2%

Stjórnsýsluleið:

TOPICAL

Einingar í pakka:

9/15/30G

Gerð lyfseðils:

OTC

Lækningarsvæði:

AZOLES

Vörulýsing:

Active ingredient group (AIG) number: 0110272001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2011-11-03

Vara einkenni

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_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MONISTAT* DERM CREAM
MICONAZOLE NITRATE
VAGINAL CREAM 2%
Antifungal Agent
Insight Pharmaceuticals LLC
660 White Plains Road, Suite 250
Tarrytown, NY 10591, USA
Date of Initial Approval:
December 31, 1980
Date of Revision:
January 18, 2021
Submission Control No: 242581
*Trademark
_ _
_ _
_Page 2 of 24_
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
........................................................................................................
5
4.4
Reconstitution
........................................................................................................
5
4.5
Missed Dose
..........................................................................................................
6
5
OVERDOSAGE
...............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
............