MONISTAT 1 VAGINAL OVULE SUPPOSITORY

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

MICONAZOLE NITRATE

Доступна с:

INSIGHT PHARMACEUTICALS, LLC

код АТС:

G01AF04

ИНН (Международная Имя):

MICONAZOLE

дозировка:

1200MG

Фармацевтическая форма:

SUPPOSITORY

состав:

MICONAZOLE NITRATE 1200MG

Администрация маршрут:

VAGINAL

Штук в упаковке:

1

Тип рецепта:

OTC

Терапевтические области:

AZOLES

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2011-11-03

Характеристики продукта

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