SILDENAFIL TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

SILDENAFIL (SILDENAFIL CITRATE)

Dostupné s:

METHAPHARM INC

ATC kód:

G04BE03

INN (Mezinárodní Name):

SILDENAFIL

Dávkování:

50MG

Léková forma:

TABLET

Složení:

SILDENAFIL (SILDENAFIL CITRATE) 50MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2016-01-18

Charakteristika produktu

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
....................