MINT-DICLOFENAC SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DICLOFENAC SODIUM

Tilgængelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

S01BC03

INN (International Name):

DICLOFENAC

Dosering:

0.1%

Lægemiddelform:

SOLUTION

Sammensætning:

DICLOFENAC SODIUM 0.1%

Indgivelsesvej:

OPHTHALMIC

Enheder i pakken:

5ML/10ML

Recept type:

Prescription

Terapeutisk område:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0114417004; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2018-04-27

Produktets egenskaber

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_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
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_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
.............