VERKAZIA EMULSION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CYCLOSPORINE

Tilgjengelig fra:

SANTEN INCORPORATED

ATC-kode:

S01XA18

INN (International Name):

CICLOSPORIN

Dosering :

0.1%

Legemiddelform:

EMULSION

Sammensetning:

CYCLOSPORINE 0.1%

Administreringsrute:

OPHTHALMIC

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

ANTI-INFLAMMATORY AGENTS, MISCELLANEOUS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-12-24

Preparatomtale

_Verkazia _
_Page 1 of 22_
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
_ _
_Verkazia _
_Page 2 of 22_
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