SANDOZ DORZOLAMIDE/TIMOLOL SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Dostupné s:

SANDOZ CANADA INCORPORATED

ATC kód:

S01ED51

INN (Mezinárodní Name):

TIMOLOL, COMBINATIONS

Dávkování:

20MG; 5MG

Léková forma:

SOLUTION

Složení:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG; TIMOLOL (TIMOLOL MALEATE) 5MG

Podání:

OPHTHALMIC

Jednotky v balení:

5ML/10ML

Druh předpisu:

Prescription

Terapeutické oblasti:

BETA-ADRENERGIC AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0237301001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2010-02-12

Charakteristika produktu

_Sandoz Dorzolamide/Timolol _
_Page 1 of 27 _
PRODUCT MONOGRAPH
PR
SANDOZ DORZOLAMIDE/TIMOLOL
Dorzolamide and timolol ophthalmic solution
20 mg / mL, 5 mg / mL
(as dorzolamide hydrochloride USP and timolol maleate USP)
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Sandoz Canada Inc.
Date of Revision: November 2, 2017
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 196003
_Sandoz Dorzolamide/Timolol _
_Page 2 of 27 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS
AND
PRECAUTIONS
.........................................................................................
4
ADVERSE
REACTIONS
...........................................................................................................
7
DRUG
INTERACTIONS
...........................................................................................................
8
DOSAGE
AND
ADMINISTRATION
.....................................................................................
10
OVERDOSAGE
.......................................................................................................................
10
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
11
STORAGE
AND
STABILITY
.................................................................................................
13
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 13
PART II: SCIENTIFIC INFORMATION
.............................................................................