Страна: Канада
мова: англійська
Джерело: Health Canada
DICLOFENAC SODIUM
MINT PHARMACEUTICALS INC
S01BC03
DICLOFENAC
0.1%
SOLUTION
DICLOFENAC SODIUM 0.1%
OPHTHALMIC
5ML/10ML
Prescription
NONSTEROIDAL ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0114417004; AHFS:
APPROVED
2018-04-27
_ _ _ _ _Page 1 of 24_ PRODUCT MONOGRAPH PR MINT-DICLOFENAC Diclofenac Sodium Ophthalmic Solution 0.1% w/v (House Standard) Anti-inflammatory Analgesic Agent Mint Pharmaceuticals Inc. 1093 Meyerside Drive, Unit 1 Mississauga, Ontario L5T 1J6 www.mintpharmaceuticals.com Date of Preparation: April 26, 2018 Submission Control No: 200405 _ _ _ _ _ _ _Page 2 of 24_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................6 DRUG INTERACTIONS ....................................................................................................7 DOSAGE AND ADMINISTRATION ................................................................................7 OVERDOSAGE ..................................................................................................................8 ACTION AND CLINICAL PHARMACOLOGY ..............................................................8 STORAGE AND STABILITY ............................................................................................9 SPECIAL HANDLING INSTRUCTIONS .........................................................................9 DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................9 PART II: SCIENTIFIC INFORMATION ...............................................................................10 PHARMACEUTICAL INFORMATION ..........................................................................10 CLINICAL TRIALS ............. Прочитайте повний документ