TEVA-BETAMETHASONE/ CALCIPOTRIOL OINTMENT
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
05-10-2016
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Werkstoffen:
BETAMETHASONE (BETAMETHASONE DIPROPIONATE); CALCIPOTRIOL
Beschikbaar vanaf:
TEVA CANADA LIMITED
ATC-code:
D07XC01
INN (Algemene Internationale Benaming):
BETAMETHASONE
Dosering:
0.5MG; 50MCG
farmaceutische vorm:
OINTMENT
Samenstelling:
BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.5MG; CALCIPOTRIOL 50MCG
Toedieningsweg:
TOPICAL
Eenheden in pakket:
120G
Prescription-type:
Prescription
Therapeutisch gebied:
ANTI-INFLAMMATORY AGENTS
Product samenvatting:
Active ingredient group (AIG) number: 0252270001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2020-01-28
Productkenmerken
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_Page 1 of 48_
PRODUCT MONOGRAPH
PR TEVA-BETAMETHASONE/CALCIPOTRIOL
betamethasone/calcipotriol ointment
0.5 mg/g betamethasone (as dipropionate)
and 50 mcg/g calcipotriol
Topical Antipsoriatic Agent
Vitamin D Analogue / Corticosteroid
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Preparation:
October 05, 2016
Submission Control No: 165693, 196018
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_Page 2 of 48_
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
................................................................................................................
8
DRUG INTERACTIONS
.................................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................................
9
OVERDOSAGE
.............................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
11
STORAGE AND STABILITY
......................................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 12
PART II: SCIENTIFIC INFORMATION
....................................................................................
14
PHARMACEUTICAL INFORMATION
.
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