ODAN-TIMOLOL SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TIMOLOL (TIMOLOL MALEATE)

Tersedia dari:

ODAN LABORATORIES LTD

Kode ATC:

S01ED01

INN (Nama Internasional):

TIMOLOL

Dosis:

0.5%

Bentuk farmasi:

SOLUTION

Komposisi:

TIMOLOL (TIMOLOL MALEATE) 0.5%

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

5ML/10ML/15ML

Jenis Resep:

Prescription

Area terapi:

BETA-ADRENERGIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0131275002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-10-05

Karakteristik produk

PRODUCT MONOGRAPH
PR
ODAN-TIMOLOL
timolol maleate ophthalmic solution, USP
0 . 2 5 % , 0.5% w/v timolol
Sterile Ophthalmic Solution
Elevated Intraocular Pressure Therapy
ODAN LABORATORIES LTD.
325, Stillview Ave.
Pointe-Claire, QC
H9R 2Y6
Canada
Date of Preparation:
September 22, 2015
SUBMISSION CONTROL NO: 187429
www.odanlab.com
_ODAN-TIMOLOL_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
INDICATIONS AND CLINICAL USE
...............................................................................
3
CONTRAINDICATIONS
.....................................................................................................
3
WARNINGS AND PRECAUTIONS
...................................................................................
3
ADVERSE REACTIONS
.....................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND ADMINISTRATION
.................................................................................
9
OVERDOSAGE
..................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 10
STORAGE AND STABILITY
...........................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 11
PART II: SCIENTIFIC INFORMATION
..................................................................................
12
PHARMACEUTICAL INFORMATION
...........................................................................
12
CLINICAL TRIALS
........................................................................................