SILDENAFIL TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SILDENAFIL (SILDENAFIL CITRATE)

Предлага се от:

METHAPHARM INC

АТС код:

G04BE03

INN (Международно Name):

SILDENAFIL

дозиране:

50MG

Лекарствена форма:

TABLET

Композиция:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2016-01-18

Данни за 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
....................