ODAN-ROSE SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ROSE BENGAL

Tersedia dari:

ODAN LABORATORIES LTD

Kode ATC:

S01JA02

INN (Nama Internasional):

ROSE BENGAL SODIUM

Dosis:

10MG

Bentuk farmasi:

SOLUTION

Komposisi:

ROSE BENGAL 10MG

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

5ML

Jenis Resep:

Ethical

Area terapi:

OTHER DIAGNOSTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0108666001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-10-14

Karakteristik produk

PRESCRIBING INFORMATION
ODAN-ROSE
ROSE BENGAL 1% OPHTHALMIC SOLUTION
STERILE DIAGNOSTIC AGENT FOR PROFESSIONAL USE
ODAN LABORATORIES LTD.
325 Stillview Ave.,
Pointe-Claire, Québec H9R 2Y6
Control No: 187900
Date of Preparation:
October 14, 2015
www.odanlab.com
_Page 2 of 2 _
PRESCRIBING INFORMATION
ODAN-ROSE
ROSE BENGAL 1% OPHTHALMIC SOLUTION
DESCRIPTION
ODAN-ROSE (Rose Bengal ophthalmic solution) is a sterile aqueous
solution for topical use
as a diagnostic aid. The product is designated for professional use
only.
CLINICAL PHARMACOLOGY
As a vital stain, ODAN-ROSE stains both the nuclei and cell walls of
dead or degenerated
epithelial cells of the cornea and conjunctiva. Rose Bengal will also
stain the mucus of the
precorneal tear film.
INDICATIONS AND CLINICAL USE
ODAN-ROSE
is
used
as
a
diagnostic
agent
in
routine
ocular
examinations
or
when
superficial conjunctiva or corneal tissue change is suspected.
ODAN-ROSE ophthalmic
solution can also serve as an effective aid in the diagnosis of
keratoconjunctivitis sicca,
keratitis, abrasions or corrosions as well as the detection of foreign
bodies.
CONTRAINDICATIONS
ODAN-ROSE is contraindicated in patients who have shown
hypersensitivity to Rose Bengal
or to any other component of the preparation.
WARNINGS AND PRECAUTIONS
•
Product may cause local irritation or stinging sensation.
•
Rose Bengal can stain exposed skin, clothing and soft contact lenses.
•
Patients should be advised of temporary colored staining of the eye,
dye needs to be
washed out after the examination.
DOSAGE AND ADMINISTRATION
Instill 1 or 2 drops in the eye prior to examination.
STORAGE AND STABILITY
Store at room temperature 15º - 30ºC.
DOSAGE FORMS, COMPOSITION AND PACKAGING
ODAN-ROSE sterile solution contains Rose Bengal 1% (10 mg/mL), and the
following non-
medicinal ingredients: octoxynol-9, povidone, sodium borate, sodium
chloride and water.
Available in 5 mL plastic dropper bottles.