TEVA-DORZOTIMOL SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Tilgængelig fra:

TEVA CANADA LIMITED

ATC-kode:

S01ED51

INN (International Name):

TIMOLOL, COMBINATIONS

Dosering:

20MG; 5MG

Lægemiddelform:

SOLUTION

Sammensætning:

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

Indgivelsesvej:

OPHTHALMIC

Enheder i pakken:

5ML/10ML

Recept type:

Prescription

Terapeutisk område:

BETA-ADRENERGIC AGENTS

Produkt oversigt:

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

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2018-06-19

Produktets egenskaber

Page 1
PRODUCT MONOGRAPH
PR
TEVA-DORZOTIMOL
dorzolamide hydrochloride and timolol maleate
Sterile Ophthalmic Solution
Each mL contains dorzolamide 20 mg and timolol 5 mg
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No.: 143236, 144749
Date of Preparation:
January 24, 2012
Page 2
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...............................................................................
14
PHARMACEUTICAL
INFORMATION......................................................................