SANDOZ CIPROFLOXACIN / DEXAMETHASONE SUSPENSION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE); DEXAMETHASONE

זמין מ:

SANDOZ CANADA INCORPORATED

קוד ATC:

S02CA06

INN (שם בינלאומי):

DEXAMETHASONE AND ANTIINFECTIVES

כמות:

0.3%; 0.1%

טופס פרצבטיות:

SUSPENSION

הרכב:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 0.3%; DEXAMETHASONE 0.1%

מסלול נתינה (של תרופות):

OTIC

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

ANTIBACTERIALS

leaflet_short:

Active ingredient group (AIG) number: 0250083001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2020-10-26

מאפייני מוצר

_Sandoz Ciprofloxacin / Dexamethasone Product Monograph _
_Page 1 of 22_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr SANDOZ
® CIPROFLOXACIN / DEXAMETHASONE
Ciprofloxacin / Dexamethasone Otic Suspension
0.3% w/v (as ciprofloxacin hydrochloride) / 0.1% w/v
Antibacterial - Corticosteroid (Otic)
Sandoz Canada Inc.
Date of Revision:
110 Rue de Lauzon,
October 20, 2020
Boucherville, Quebec
J4B 1E6
www.sandoz.ca
Submission Control No.: 243712
_Sandoz Ciprofloxacin / Dexamethasone Product Monograph _
_Page 2 of 22_
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
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STABILITY
............................................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
................................................................................11
PHARMACEUTICAL INFORMATION
.........................................