VERKAZIA EMULSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CYCLOSPORINE

Available from:

SANTEN INCORPORATED

ATC code:

S01XA18

INN (International Name):

CICLOSPORIN

Dosage:

0.1%

Pharmaceutical form:

EMULSION

Composition:

CYCLOSPORINE 0.1%

Administration route:

OPHTHALMIC

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS, MISCELLANEOUS

Product summary:

Active ingredient group (AIG) number: 0115996009; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-12-24

Summary of Product characteristics

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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
VERKAZIA™
Cyclosporine
Topical Ophthalmic Emulsion, 0.1% w/v
Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals,
ATC code: S01XA18
Santen Incorporated
6401 Hollis Street, Suite 125
Emeryville, CA 94608
Canadian Importer
McKesson Specialized Distribution, Inc.
8449 Lawson Rd
ON L9T 9L1
DEL Number: 3-002497-B
Date of Initial Approval:
December 21, 2018
Submission Control No: 215813
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TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4
1
INDICATIONS
....................................................................................................................4
1.1
Pediatrics
....................................................................................................................4
1.2
Geriatrics
....................................................................................................................4
2
CONTRAINDICATIONS ..................................................................................................4
3
DOSAGE AND ADMINISTRATION ...............................................................................4
3.1
Dosing Considerations
...............................................................................................4
3.2
Recommended Dose and Dosage Adjustment
...........................................................4
3.3
Administration
...........................................................................................................5
3.4
Missed Dose
...............................................................................................................5
4
OVERDOSAGE .................................................................................................................5
5
DOSAGE FORMS, STRENGTHS, COMPOSIT