TEVA-TOPISONE OINTMENT
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
24-02-2021
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Aktívna zložka:
BETAMETHASONE (BETAMETHASONE DIPROPIONATE)
Dostupné z:
TEVA CANADA LIMITED
ATC kód:
D07AC01
INN (Medzinárodný Name):
BETAMETHASONE
Dávkovanie:
0.05%
Forma lieku:
OINTMENT
Zloženie:
BETAMETHASONE (BETAMETHASONE DIPROPIONATE) 0.05%
Spôsob podávania:
TOPICAL
Počet v balení:
15/50/450G
Typ predpisu:
Prescription
Terapeutické oblasti:
ANTI-INFLAMMATORY AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0106299002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2002-03-08
Súhrn charakteristických
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-TOPISONE
BETAMETHASONE DIPROPIONATE
USP
0.05% W/W BETAMETHASONE (AS DIPROPIONATE) CREAM, OINTMENT AND LOTION
TOPICAL CORTICOSTEROID
TEVA CANADA LIMITED
DATE OF REVISION
30 NOVOPHARM COURT
FEB.24, 2021
TORONTO, ONTARIO
CANADA M1B 2K9
WWW.TEVACANADA.COM
CONTROL #: 245679
Page 2
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
1.
INDICATIONS
......................................................................................................
3
1.1 PEDIATRICS
.........................................................................................................
3
1.2 GERIATRICS
.........................................................................................................
3
2.
CONTRAINDICATIONS
........................................................................................
4
3.
DOSAGE AND ADMINISTRATION
......................................................................
4
3.1 DOSING CONSIDERATIONS
....................................................................................
4
3.2 ADMINISTRATION
..................................................................................................
4
4.
MISSED DOSE
.....................................................................................................
4
5.
OVERDOSAGE
.....................................................................................................
5
6.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. 5
7.
WARNINGS AND PRECAUTIONS
.......................................................................
6
7.1 SPECIAL POPULATIONS
.........................................................................................
7
7.1.1 PREGNANT WOMEN
...........................................................................................
7
7.1.2 BREAST-FEEDING
...............................................................................................
7
7.1.3 PEDIATRICS
.
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