SANDOZ-DICLOFENAC TABLET (DELAYED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DICLOFENAC SODIUM

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

M01AB05

INN (Διεθνής Όνομα):

DICLOFENAC

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

TABLET (DELAYED-RELEASE)

Σύνθεση:

DICLOFENAC SODIUM 50MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0114417002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2021-02-04

Αρχείο Π.Χ.Π.

_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
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PRODUCT MONOGRAPH
PR
SANDOZ-DICLOFENAC
PR
SANDOZ-DICLOFENAC SR
(diclofenac sodium)
50 mg Enteric-Coated Tablets
75 and 100 mg Slow-Release Tablets
50 mg Suppositories
Acetic Acid Derivatives and Related Substances
Sandoz Canada Inc.
Date of revision:
110 Rue de Lauzon
June 6, 2022
Boucherville,
Quebec
J4B 1E6
Control no. 259798
_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
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_Page 2 of 42 _
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
...................................................................................................16
DRUG
INTERACTIONS....................................................................................................19
DOSAGE AND
ADMINISTRATION.................................................................................22
OVERDOSAGE
.................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
................................................................25
STORAGE AND
STABILITY............................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................27
PART II: SCIENTIFIC INFORMATION
...........................................................................28
PHARMACEUTICAL
INFORMATION.............................................................................28
CLINICAL TRIALS
.......