PMS-PRUCALOPRIDE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE)

Доступна з:

PHARMASCIENCE INC

Код атс:

A06AX05

ІПН (Міжнародна Ім'я):

PRUCALOPRIDE

Дозування:

1MG

Фармацевтична форма:

TABLET

Склад:

PRUCALOPRIDE (PRUCALOPRIDE SUCCINATE) 1MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS GI DRUGS

Огляд продуктів:

Active ingredient group (AIG) number: 0153049001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2020-06-05

Характеристики продукта

_pms-PRUCALOPRIDE – Product Monograph_
1 of 37
_ _
PRODUCT MONOGRAPH
PR
PMS-PRUCALOPRIDE
Prucalopride Tablets
1 mg and 2 mg Prucalopride as Prucalopride Succinate
House Standard
Prokinetic agent
PHARMASCIENCE INC.
Date of Approval:
6111 Royalmount Ave., Suite 100
June 3, 2020
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control No: 223701
_pms-PRUCALOPRIDE – Product Monograph_
2 of 37
_ _
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
............................................................................................................
11
DOSAGE AND ADMINISTRATION
........................................................................................
12
OVERDOSAGE
..........................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
13
STORAGE AND STABILITY
....................................................................................................
17
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 17
PART II: SCIENTIFIC INFORMATION
......................................