AVA-DICLOFENAC TABLET (ENTERIC-COATED)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DICLOFENAC SODIUM

Dostopno od:

AVANSTRA INC

Koda artikla:

M01AB05

INN (mednarodno ime):

DICLOFENAC

Odmerek:

25MG

Farmacevtska oblika:

TABLET (ENTERIC-COATED)

Sestava:

DICLOFENAC SODIUM 25MG

Pot uporabe:

ORAL

Enote v paketu:

100

Tip zastaranja:

Prescription

Terapevtsko območje:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0114417003; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2014-08-21

Lastnosti izdelka

_Ava-Diclofenac and Ava-Diclofenac SR _
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_Page 1 of 35 _
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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_Page 2 of 35 _
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
..