Страна: Канада
Език: английски
Източник: Health Canada
ROSE BENGAL
ODAN LABORATORIES LTD
S01JA02
ROSE BENGAL SODIUM
10MG
SOLUTION
ROSE BENGAL 10MG
OPHTHALMIC
5ML
Ethical
OTHER DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0108666001; AHFS:
APPROVED
2015-10-14
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. Прочетете целия документ