ACCEL-SILDENAFIL TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SILDENAFIL (SILDENAFIL CITRATE)

Dostępny od:

ACCEL PHARMA INC

Kod ATC:

G04BE03

INN (International Nazwa):

SILDENAFIL

Dawkowanie:

100MG

Forma farmaceutyczna:

TABLET

Skład:

SILDENAFIL (SILDENAFIL CITRATE) 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

4/8

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0136261003; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2018-08-03

Charakterystyka produktu

_________________________________________________________________________________
_
_ACCEL-SILDENAFIL (sildenafil citrate) Product Monograph _
_Page 1 of 49_
PRODUCT MONOGRAPH
PR
ACCEL-SILDENAFIL
sildenafil as sildenafil citrate
Tablets 25 mg, 50 mg and 100 mg
House Standard
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Accel Pharma Inc.
99 Place Frontenac
Pointe-Claire, Quebec
H9R 4Z7
Date of Revision:
December 27, 2018
SUBMISSION CONTROL NO: 222236
_________________________________________________________________________________
_
_ACCEL-SILDENAFIL (sildenafil citrate) Product Monograph _
_Page 2 of 49_
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
....................................................................................................
12
DOSAGE AND ADMINISTRATION
................................................................................
15
OVERDOSAGE
..................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 17
STORAGE AND STABILITY
............................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
20
DOSAGE FORMS, CO