MYLAN-VARDENAFIL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE TRIHYDRATE)

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

G04BE09

INN (International Name):

VARDENAFIL

Dosering :

20MG

Legemiddelform:

TABLET

Sammensetning:

VARDENAFIL (VARDENAFIL HYDROCHLORIDE TRIHYDRATE) 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

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_Page 1 of 58_
PRODUCT MONOGRAPH
PR
MYLAN-VARDENAFIL
Vardenafil tablets
5 mg, 10 mg, 20 mg of vardenafil, as vardenafil hydrochloride
trihydrate
cyclic GMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision
June 22, 2020
Submission Control No: 240066
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_Page 2 of 58_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
TREATMENT OF
PRIAPISM…………………………………………………...……..
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL
TRIALS…�