দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
DICLOFENAC SODIUM; MISOPROSTOL
SANDOZ CANADA INCORPORATED
M01AB55
DICLOFENAC, COMBINATIONS
50MG; 200MCG
TABLET
DICLOFENAC SODIUM 50MG; MISOPROSTOL 200MCG
ORAL
100/250/500
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0222885003; AHFS:
CANCELLED PRE MARKET
2021-04-21
_ _ _Sandoz DiclofenacMisoprostol _ _Page 1 of 48_ PRODUCT MONOGRAPH Pr SANDOZ DICLOFENAC MISOPROSTOL Diclofenac Sodium and Misoprostol Enteric-Coated Tablets 50 mg diclofenac sodium / 200 mcg misoprostol 75 mg diclofenac sodium / 200 mcg misoprostol NSAID with a Mucosal Protective Agent Sandoz Canada Inc. 145 Jules-Léger Boucherville, QC, Canada J4B 7K8 Date of Revision: March 19, 2015 Control no.: 182760 _ _ _Sandoz DiclofenacMisoprostol _ _Page 2 of 48_ 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 ........................................................................................................... 18 DOSAGE AND ADMINISTRATION ....................................................................................... 22 OVERDOSAGE ......................................................................................................................... 23 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 24 STORAGE AND STABILITY................................................................................................... 26 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 26 PART II: SCIENTIFIC INFORMATION ................................................................................ 28 PHARMACEUTICAL INFORMATION ........ সম্পূর্ণ নথি পড়ুন