MONISTAT DERM CREAM

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

MICONAZOLE NITRATE

Доступна з:

INSIGHT PHARMACEUTICALS, LLC

Код атс:

D01AC02

ІПН (Міжнародна Ім'я):

MICONAZOLE

Дозування:

2%

Фармацевтична форма:

CREAM

Склад:

MICONAZOLE NITRATE 2%

Адміністрація маршрут:

TOPICAL

Одиниць в упаковці:

9/15/30G

Тип рецепту:

OTC

Терапевтична области:

AZOLES

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2011-11-03

Характеристики продукта

_ _
_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
............