ODAN-ROSE

Main information

  • Trade name:
  • ODAN-ROSE SOLUTION
  • Dosage:
  • 10MG
  • Pharmaceutical form:
  • SOLUTION
  • Composition:
  • ROSE BENGAL 10MG
  • Administration route:
  • OPHTHALMIC
  • Units in package:
  • 5ML
  • Prescription type:
  • Ethical
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ODAN-ROSE SOLUTION
    Canada
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • OTHER DIAGNOSTICS
  • Product summary:
  • Active ingredient group (AIG) number: 0108666001; AHFS: 36:89.00

Other information

Status

  • Source:
  • Health Canada
  • Authorization status:
  • APPROVED
  • Authorization number:
  • 00832170
  • Authorization date:
  • 14-10-2015
  • Last update:
  • 27-11-2018

Summary of Product characteristics: dosage,interactions,side effects

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

used

diagnostic

agent

routine

ocular

examinations

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.

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

11-5-2018

Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design

Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design

Vyaire Medical is recalling the AirLife Resuscitation Device & Broselow Convenience Kit due to an error in its product design that may result in difficultly or the inability to disconnect the mask from the elbow of the resuscitator.

FDA - U.S. Food and Drug Administration

There are no news related to this product.