DOVOBET OINTMENT

País: Canadá

Idioma: inglés

Fuente: Health Canada

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06-04-2016

Ingredientes activos:

CALCIPOTRIOL; BETAMETHASONE (BETAMETHASONE DIPROPIONATE)

Disponible desde:

LEO PHARMA INC

Código ATC:

D05AX52

Designación común internacional (DCI):

CALCIPOTRIOL, COMBINATIONS

Dosis:

50MCG; 0.5MG

formulario farmacéutico:

OINTMENT

Composición:

CALCIPOTRIOL 50MCG; BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.5MG

Vía de administración:

TOPICAL

Unidades en paquete:

30G/60G/120G

tipo de receta:

Prescription

Área terapéutica:

ANTI-INFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0252270001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2001-07-11

Ficha técnica

                                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
.....................
                                
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