TEVA-DICLOFENAC SUPPOSITORY
Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
Produkta apraksts
(SPC)
22-08-2016
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Aktīvā sastāvdaļa:
DICLOFENAC SODIUM
Pieejams no:
TEVA CANADA LIMITED
ATĶ kods:
M01AB05
SNN (starptautisko nepatentēto nosaukumu):
DICLOFENAC
Deva:
100MG
Zāļu forma:
SUPPOSITORY
Kompozīcija:
DICLOFENAC SODIUM 100MG
Ievadīšanas:
RECTAL
Vienības iepakojumā:
30
Receptes veids:
Prescription
Ārstniecības joma:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Produktu pārskats:
Active ingredient group (AIG) number: 0114417001; AHFS:
Autorizācija statuss:
CANCELLED POST MARKET
Autorizācija datums:
2018-06-15
Produkta apraksts
Page 1 of 45
PRODUCT MONOGRAPH
Pr
TEVA-DICLOFENAC EC
Pr
TEVA-DICLOFENAC SR
Pr
TEVA-DICLOFENAC
(diclofenac sodium)
25 mg and 50 mg Enteric Coated Tablets, USP
75 mg and 100 mg Slow Release Tablets, Teva Standard
50 mg and 100 mg Suppositories, Teva Standard
Nonsteroidal Anti-Inflammatory Drug (NSAID)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
August 15, 2016
Control no. 197101
Page 2 of 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................
4
CONTRAINDICATIONS
......................................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................................
6
ADVERSE REACTIONS
....................................................................................................
16
DRUG INTERACTIONS
.....................................................................................................
18
DOSAGE AND ADMINISTRATION
.................................................................................
22
OVERDOSAGE
...................................................................................................................
24
ACTION AND CLINICAL
PHARMACOLOGY................................................................
24
STORAGE AND STABILITY
.............................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 27
PART II: SCIENTIFIC INFORMATION
...................................................................................
28
PHARMACEUTICAL INFORMATION
.......................................................................
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