TEVA-DOXYLAMINE/PYRIDOXINE DR TABLET (DELAYED-RELEASE)

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Доступна с:

TEVA CANADA LIMITED

код АТС:

R06AA59

ИНН (Международная Имя):

DOXYLAMINE, COMBINATIONS

дозировка:

10MG; 10MG

Фармацевтическая форма:

TABLET (DELAYED-RELEASE)

состав:

DOXYLAMINE SUCCINATE 10MG; PYRIDOXINE HYDROCHLORIDE 10MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

ANTIHISTAMINES

Обзор продуктов:

Active ingredient group (AIG) number: 0213346001; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2010-07-06

Характеристики продукта

PRODUCT MONOGRAPH
PR
TEVA-DOXYLAMINE/PYRIDOXINE DR
(doxylamine succinate and pyridoxine hydrochloride)
Delayed release tablets, 10 mg/ 10 mg
Antinauseant against Nausea and Vomiting of Pregnancy
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 108249, 163410, 176476, 194536
Date of Preparation:
May 12, 2016
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
..............................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
...............................................................................................
6
DRUG INTERACTIONS
...............................................................................................
9
DOSAGE AND ADMINISTRATION
.........................................................................
10
OVERDOSAGE
...........................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 11
STORAGE AND STABILITY
.....................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
.................................................................. 15
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................ 15
PART II: SCIENTIFIC INFORMATION
................................................................... 16
PHARMACEUTICAL INFORMATION
.....................................................................
16
CLINICAL TRIALS
.....................................................................................................
18
TO