SANDOZ TOBRAMYCIN / DEXAMETHASONE OINTMENT

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DEXAMETHASONE; TOBRAMYCIN

Tilgjengelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

S01CA01

INN (International Name):

DEXAMETHASONE AND ANTIINFECTIVES

Dosering :

0.1%; 0.3%

Legemiddelform:

OINTMENT

Sammensetning:

DEXAMETHASONE 0.1%; TOBRAMYCIN 0.3%

Administreringsrute:

OPHTHALMIC

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

ANTIBACTERIALS

Produkt oppsummering:

Active ingredient group (AIG) number: 0220325001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-07-07

Preparatomtale

_Sandoz_
_®_
_ Tobramycin / Dexamethasone Product Monograph _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ
® TOBRAMYCIN / DEXAMETHASONE
Tobramycin and Dexamethasone Ophthalmic Suspension, USP
0.3%/ 0.1% w/v
Tobramycin and Dexamethasone Ophthalmic Ointment, USP
0.3%/ 0.1% w/w
Antibacterial and Corticosteroid
Sandoz Canada Inc.
110, De Lauzon
Boucherville, Quebec, J4B 1E6
www.sandoz.ca
Date of Revision:
July 5, 2021
Submission Control No: 251593
®
Registered trademark used under license
_ _
_Sandoz_
_®_
_ Tobramycin / Dexamethasone 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
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
........................................................................