APO-VARDENAFIL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE)

Tilgjengelig fra:

APOTEX INC

ATC-kode:

G04BE09

INN (International Name):

VARDENAFIL

Dosering :

20MG

Legemiddelform:

TABLET

Sammensetning:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE) 20MG

Administreringsrute:

ORAL

Enheter i pakken:

4/30/100

Resept typen:

Prescription

Terapeutisk område:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0150003003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-11-01

Preparatomtale

Page 1 of 58
PRODUCT MONOGRAPH
PR
APO-VARDENAFIL
Vardenafil Tablets, BP
5 mg, 10 mg, and 20 mg of vardenafil (as vardenafil hydrochloride)
cyclic GMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
August 06, 2020
SUBMISSION CONTROL NO: 240411
Page 2 of 58
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
..................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
TREATMENT OF PRIAPISM
.........................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
........................................................................
24
CLINICAL TRIALS
.............