SILDENAFIL TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

SILDENAFIL (SILDENAFIL CITRATE)

Доступна з:

METHAPHARM INC

Код атс:

G04BE03

ІПН (Міжнародна Ім'я):

SILDENAFIL

Дозування:

50MG

Фармацевтична форма:

TABLET

Склад:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Огляд продуктів:

Active ingredient group (AIG) number: 0136261002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2016-01-18

Характеристики продукта

SILDENAFIL (sildenafil citrate) Product Monograph
Page 1 of 43
PRODUCT MONOGRAPH
PR SILDENAFIL
sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
SUBMISSION CONTROL NO: 181471
Methapharm Inc.
81 Sinclair Boulevard
Brantford, Ontario N3S 7X6
DATE OF PREPARATION:
January 14, 2016
SILDENAFIL (sildenafil citrate) Product Monograph
Page 2 of 43
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
.....................................................................................................7
DRUG INTERACTIONS
...................................................................................................10
DOSAGE AND ADMINISTRATION
...............................................................................13
OVERDOSAGE
..................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
..............................................................15
STORAGE AND STABILITY
...........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.........................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL INFORMATION
....................