TEVA-ACYCLOVIR TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

ACYCLOVIR

Доступна с:

TEVA CANADA LIMITED

код АТС:

J05AB01

ИНН (Международная Имя):

ACYCLOVIR

дозировка:

200MG

Фармацевтическая форма:

TABLET

состав:

ACYCLOVIR 200MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

NUCLEOSIDES AND NUCLEOTIDES

Обзор продуктов:

Active ingredient group (AIG) number: 0115506002; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2011-01-06

Характеристики продукта

Teva-Acyclovir
Page 1 of 40
_ _
_ _
PRODUCT MONOGRAPH
PR
TEVA-ACYCLOVIR
Acyclovir Tablets, USP
200 mg, 400 mg and 800 mg
(Acyclovir, as Acyclovir Hydrate)
ANTIVIRAL AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Canada
Ontario M1B 2K9
Date of Revision:
April 28, 2015
Submission Control No: 183526
Teva-Acyclovir
Page 2 of 40
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
...............................................................................
9
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
.........................................................................................................
15
DETAILED PHARMACOLOGY
.................