PRIVA-DORZOLAMIDE-TIMOLOL SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Tilgængelig fra:

PHARMAPAR INC

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:

100

Recept type:

Prescription

Terapeutisk område:

BETA-ADRENERGIC AGENTS

Produkt oversigt:

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

Autorisation status:

CANCELLED PRE MARKET

Autorisation dato:

2022-07-29

Produktets egenskaber

_Page 1 of 26_
PRODUCT MONOGRAPH
PR
PRIVA-DORZOLAMIDE-TIMOLOL
Dorzolamide and timolol eye drops
BP
2
0 mg/ml, 5
mg/ml
(as dorzolamide hydrochloride and timolol maleate)
Elevated Intraocular Pressure
Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical
Beta-Adrenergic
Blocking
Agent)
PHARMAPAR INC.
1565 Boul. Lionel-Boulet
Varennes, Quebec
J3X 1P7
DATE OF REVISION:
August 26, 2020
SUBMISSION CONTROL NO.:
241471
_Page 2 of 26_
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
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND
STABILITY..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
.................................................................................14
PHARMACEUTICAL
INFORMATION...........................................................................14
CLINICAL TRIALS
...................................................