VITAROS CREAM
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
09-01-2015
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Aktiva substanser:
ALPROSTADIL
Tillgänglig från:
BGP PHARMA ULC
ATC-kod:
G04BE01
INN (International namn):
ALPROSTADIL
Dos:
220MCG
Läkemedelsform:
CREAM
Sammansättning:
ALPROSTADIL 220MCG
Administreringssätt:
TOPICAL
Enheter i paketet:
100MG
Receptbelagda typ:
Prescription
Terapiområde:
MISCELLANEOUS VASODILATATING AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0115288013; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2015-01-22
Produktens egenskaper
_ _
_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
.......................................................................
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