RIVA-DORZOLAMIDE SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Tersedia dari:

LABORATOIRE RIVA INC.

Kode ATC:

S01EC03

INN (Nama Internasional):

DORZOLAMIDE

Dosis:

2%

Bentuk farmasi:

SOLUTION

Komposisi:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

5ML

Jenis Resep:

Prescription

Area terapi:

CARBONIC ANHYDRASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0128558001; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-10-30

Karakteristik produk

_RIVA-DORZOLAMIDE Product Monograph _
_ _
_Page 1 of 18 _
PRODUCT
MONOGRAPH
PR
RIVA-DORZOLAMIDE
Dorzolamide Ophthalmic Solution, BP
2% weight/volume dorzolamide (as dorzolamide hydrochloride)
Sterile Ophthalmic Solution
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
LABORATOIRE RIVA INC.
660 Industriel Blvd.
Blainville, Quebec
J7C 3V4
www.labriva.com DATE OF REVISION:
December 06, 2016
CONTROL NO. 199594
_RIVA-DORZOLAMIDE Product Monograph _
_ _
_Page 2 of 18 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY
.................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................................
3
INDICATIONS AND CLINICAL USE
.......................................................................................
3
CONTRAINDICATIONS
............................................................................................................
3
WARNINGS AND PRECAUTIONS
..........................................................................................
3
ADVERSE REACTIONS
............................................................................................................
5
DRUG INTERACTIONS
.............................................................................................................
6
DOSAGE AND ADMINISTRATION
.........................................................................................
7
OVERDOSAGE
...........................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
8
STORAGE AND STABILITY
....................................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 9
PART II: SCIENTIFIC INFORMATION
................................................................................
10
PHARMACE