מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
ALPROSTADIL
BGP PHARMA ULC
G04BE01
ALPROSTADIL
220MCG
CREAM
ALPROSTADIL 220MCG
TOPICAL
100MG
Prescription
MISCELLANEOUS VASODILATATING AGENTS
Active ingredient group (AIG) number: 0115288013; AHFS:
APPROVED
2015-01-22
_ _ _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 ....................................................................... קרא את המסמך השלם