VITAROS CREAM

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ALPROSTADIL

Tilgjengelig fra:

BGP PHARMA ULC

ATC-kode:

G04BE01

INN (International Name):

ALPROSTADIL

Dosering :

220MCG

Legemiddelform:

CREAM

Sammensetning:

ALPROSTADIL 220MCG

Administreringsrute:

TOPICAL

Enheter i pakken:

100MG

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS VASODILATATING AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0115288013; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2015-01-22

Preparatomtale

_ _
_VITAROS_
_™ _
_Product Monograph _
_Page 1 of 38_
PRODUCT MONOGRAPH
Pr
VITAROS™
alprostadil
Cream 220 mcg/ 100 mg, 330 mcg/ 100 mg
Alprostadil for Treatment of Male Erectile Dysfunction
BGP Pharma Inc.
8401 Trans-Canada Highway
St-Laurent, Qc H4S 1Z1
Control Number : 180901
Date of Preparation:
January 8, 2015
_ _
_VITAROS_
_™_
_ Product Monograph _
_Page 2 of 38_
TABLE OF CONTENTS PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................13
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL INFORMATION
.......................................................................