TARO-CALCIPOTRIOL / BETAMETHASONE GEL

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CALCIPOTRIOL (CALCIPOTRIOL MONOHYDRATE); BETAMETHASONE (BETAMETHASONE DIPROPIONATE)

Dostupno od:

TARO PHARMACEUTICALS INC

ATC koda:

D05AX52

INN (International ime):

CALCIPOTRIOL, COMBINATIONS

Doziranje:

50MCG; 0.5MG

Farmaceutski oblik:

GEL

Sastav:

CALCIPOTRIOL (CALCIPOTRIOL MONOHYDRATE) 50MCG; BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.5MG

Administracija rute:

TOPICAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

Active ingredient group (AIG) number: 0252270002; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2022-02-10

Svojstava lijeka

_ _
_Taro-Calcipotriol / Betamethasone Gel _
_ _
_ _
_ _
_ _
_ _
_Page 1 of 45 _
PRODUCT MONOGRAPH
PR
TARO-CALCIPOTRIOL / BETAMETHASONE GEL
calcipotriol and betamethasone dipropionate gel
50 mcg/g calcipotriol (as monohydrate)
and
0.5 mg/g betamethasone (as dipropionate)
gel
Topical Antipsoriatic Agent
Vitamin D Analogue / Corticosteroid
Taro Pharmaceuticals Inc.
Date of Preparation:
130 East Drive
February 09, 2022
Brampton, ON
L6T 1C1
Submission
Control No.: 253642
_ _
_Taro-Calcipotriol / Betamethasone Gel _
_ _
_ _
_ _
_ _
_ _
_Page 2 of 45 _
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
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL
INFORMATION............................