País: Canadá
Idioma: inglés
Fuente: Health Canada
CALCIPOTRIOL; BETAMETHASONE (BETAMETHASONE DIPROPIONATE)
LEO PHARMA INC
D05AX52
CALCIPOTRIOL, COMBINATIONS
50MCG; 0.5MG
OINTMENT
CALCIPOTRIOL 50MCG; BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.5MG
TOPICAL
30G/60G/120G
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0252270001; AHFS:
APPROVED
2001-07-11
LEO® _ _ _Dovobet® (calcipotriol and betamethasone dipropionate) Product Monograph, version xx _ _Page 1 of 43_ PRODUCT MONOGRAPH PR DOVOBET® calcipotriol and betamethasone dipropionate Ointment, 50 mcg/g calcipotriol (as monohydrate) and 0.5 mg/g betamethasone (as dipropionate) Topical Antipsoriatic Agent Vitamin D Analogue / Corticosteroid LEO Pharma Inc. Thornhill, Ontario L3T 7W8 www.leo-pharma.ca Date of Revision: APRIL 4, 2016 Control #190820 ®Registered trademark of LEO Pharma A/S used under license by LEO Pharma Inc., Thornhill, ON LEO® _ _ _Dovobet® (calcipotriol and betamethasone dipropionate) Product Monograph, version xx _ _Page 2 of 43_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE ...................................................................................... 3 CONTRAINDICATIONS ........................................................................................................... 3 WARNINGS AND PRECAUTIONS ......................................................................................... 4 ADVERSE REACTIONS ........................................................................................................... 7 DRUG INTERACTIONS ........................................................................................................... 9 DOSAGE AND ADMINISTRATION ........................................................................................ 9 OVERDOSAGE ....................................................................................................................... 10 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 11 STORAGE AND STABILITY ................................................................................................. 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................... Leer el documento completo