VITAROS CREAM

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ALPROSTADIL

Dostępny od:

BGP PHARMA ULC

Kod ATC:

G04BE01

INN (International Nazwa):

ALPROSTADIL

Dawkowanie:

330MCG

Forma farmaceutyczna:

CREAM

Skład:

ALPROSTADIL 330MCG

Droga podania:

TOPICAL

Sztuk w opakowaniu:

100MG

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS VASODILATATING AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2015-01-22

Charakterystyka 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
.......................................................................