Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
DICLOFENAC SODIUM
TEVA CANADA LIMITED
M01AB05
DICLOFENAC
50MG
TABLET (ENTERIC-COATED)
DICLOFENAC SODIUM 50MG
ORAL
100/500/1000
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114417002; AHFS:
CANCELLED PRE MARKET
2015-08-06
1 PRODUCT MONOGRAPH Pr NTP-DICLOFENAC SODIUM Pr NTP-DICLOFENAC SODIUM SR (Diclofenac Sodium) 50 mg Enteric Coated Tablets 75 mg Slow Release Tablets Non steroidal Anti-Inflammatory Drug (NSAID) Teva Canada Limited 30 Novopharm Court Toronto, Ontario Canada, M1B 2K9 Submission Control No: 165996 Date of Preparation: July 22, 2013 2 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 ..................................................................................... 15 DRUG INTERACTIONS ..................................................................................... 17 DOSAGE AND ADMINISTRATION ................................................................. 20 OVERDOSAGE ................................................................................................... 22 ACTION AND CLINICAL PHARMACOLOGY ............................................... 22 STORAGE AND STABILITY ............................................................................. 24 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................ 24 PART II: SCIENTIFIC INFORMATION ................................................................... 26 PHARMACEUTICAL INFORMATION ............................................................. 26 CLINICAL TRIALS ............................................................................................. 27 DETAILED PHARMACOLOGY ........................................................................ 30 TOXICOLOGY .................................................................................................... 31 REFERENCES Կարդացեք ամբողջական փաստաթուղթը