TEVA-CYCLOSPORINE EMULSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CYCLOSPORINE

Available from:

TEVA CANADA LIMITED

ATC code:

S01XA18

INN (International Name):

CICLOSPORIN

Dosage:

0.05%

Pharmaceutical form:

EMULSION

Composition:

CYCLOSPORINE 0.05%

Administration route:

OPHTHALMIC

Units in package:

0.4ML

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS, MISCELLANEOUS

Product summary:

Active ingredient group (AIG) number: 0115996006; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-03-14

Summary of Product characteristics

_TEVA-CYCLOSPORINE Product Monograph _
_Page 1 of 29 _
PRODUCT MONOGRAPH
PR
TEVA-CYCLOSPORINE
Cyclosporine
Ophthalmic Emulsion, 0.05% w/v
Teva Standard
Anti-Inflammatory / Immunomodulator
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Date of Preparation:
March 14, 2017
Submission Control No: 190985
_TEVA-CYCLOSPORINE Product Monograph _
_Page 2 of 29 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
5
DRUG INTERACTIONS
...................................................................................................
7
DOSAGE AND ADMINISTRATION
...............................................................................
7
OVERDOSAGE
.................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 9
STORAGE AND STABILITY
.........................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 10
PART II: SCIENTIFIC INFORMATION
...............................................................................
11
PHARMACEUTICAL INFORMATION
.........................................................................
11
CLINICAL TRIALS
.........................................................................................................
11
DETA