SANDOZ CIPROFLOXACIN / DEXAMETHASONE SUSPENSION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE); DEXAMETHASONE

Dostopno od:

SANDOZ CANADA INCORPORATED

Koda artikla:

S02CA06

INN (mednarodno ime):

DEXAMETHASONE AND ANTIINFECTIVES

Odmerek:

0.3%; 0.1%

Farmacevtska oblika:

SUSPENSION

Sestava:

CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) 0.3%; DEXAMETHASONE 0.1%

Pot uporabe:

OTIC

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTIBACTERIALS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-10-26

Lastnosti izdelka

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