AVA-DICLOFENAC TABLET (ENTERIC-COATED)
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
12-10-2012
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Aktivní složka:
DICLOFENAC SODIUM
Dostupné s:
AVANSTRA INC
ATC kód:
M01AB05
INN (Mezinárodní Name):
DICLOFENAC
Dávkování:
25MG
Léková forma:
TABLET (ENTERIC-COATED)
Složení:
DICLOFENAC SODIUM 25MG
Podání:
ORAL
Jednotky v balení:
100
Druh předpisu:
Prescription
Terapeutické oblasti:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0114417003; AHFS:
Stav Autorizace:
CANCELLED POST MARKET
Datum autorizace:
2014-08-21
Charakteristika produktu
_Ava-Diclofenac and Ava-Diclofenac SR _
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PRODUCT MONOGRAPH
PR
AVA-DICLOFENAC
PR AVA-DICLOFENAC SR
(diclofenac sodium)
25 mg and 50 mg Enteric-Coated Tablets
75 and 100 mg Slow-Release Tablets
Nonsteroidal Anti-Inflammatory Drug (NSAID)
Date of Revision:
October 12, 2012
Avanstra Inc
10761-25
th
str.NE, Suite 110
Calgary, Alberta, Canada
T3N 0A4
Control no. 158868
_Ava-Diclofenac and Ava-Diclofenac SR _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...................................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................................
3
CONTRAINDICATIONS
..............................................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................................
5
ADVERSE REACTIONS
.............................................................................................................
13
DRUG INTERACTIONS
.............................................................................................................
15
DOSAGE AND ADMINISTRATION
.........................................................................................
18
OVERDOSAGE
...........................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
20
STORAGE AND STABILITY
.....................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
..
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