VITAROS CREAM

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ALPROSTADIL

Dostupné s:

BGP PHARMA ULC

ATC kód:

G04BE01

INN (Mezinárodní Name):

ALPROSTADIL

Dávkování:

330MCG

Léková forma:

CREAM

Složení:

ALPROSTADIL 330MCG

Podání:

TOPICAL

Jednotky v balení:

100MG

Druh předpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS VASODILATATING AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0115288014; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2015-01-22

Charakteristika produktu

_ _
_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
.......................................................................