ARTELAC REBALANCE eye drops 10ml
Intended Use: Eye lubricant and contact lens rewetting solution.
Indications: Artelac™ Rebalance is indicated for people suffering from a range of dry eye symptoms such as tiredness, eye strain, a gritty sensation, burning, and/or watery eyes.
What is Artelac™ Rebalance used for?
Artelac™ Rebalance is an eye lubricant in a convenient bottle, specifically designed to relieve and soothe persistent symptoms of dry eyes. Artelac™ Rebalance is compatible with all types of soft and hard contact lenses while being worn and noticeably improves contact lens comfort throughout the day.
When should you use Artelac™ Rebalance?
It contains key components that are naturally present in the eyes and tears: sodium hyaluronate—an effective moisturizer, nutrients, and ions such as potassium, magnesium, sodium, and calcium. PEG 8000 is an additional moisturizing agent that supports long-lasting hydration. Vitamin B12 gives Artelac™ Rebalance its pink color, which quickly disappears upon blinking. It does not stain clothing or contact lenses.
Artelac™ Rebalance is designed to remain on the eye surface, providing long-lasting hydration for all dry eye symptoms by supplementing the natural tear film with essential components. It is suitable for anyone experiencing symptoms of dry eyes such as tiredness, eye strain, burning, and/or watery eyes.
Dry eyes may be caused by external factors such as intensive computer use, air conditioning, heating, cigarette smoke, windy outdoor environments, and contact lens wear. Other contributing factors include certain medications (such as oral contraceptives, antihistamines, beta-blockers, antispasmodics, and diuretics) or specific medical conditions that play a role in the development of dry eye disease.
Composition
Artelac™ Rebalance is a clear, pink-colored eye drop solution containing:
0.15% sodium hyaluronate
0.5% polyethylene glycol 8000 (PEG 8000)
potassium chloride
calcium chloride
magnesium chloride
sodium chloride
vitamin B12
purified water
boric acid
Oxyd® (a gentle preservative that is converted into water, oxygen, and salt on the eye surface)
This multi-component formulation is suitable for providing prolonged relief and protection in dry eye syndrome caused by chronic tear dysfunction. Artelac™ Rebalance is hypotonic and soothes the eye by helping restore the physiological osmotic balance of the tear film and ocular surface.
Directions for Use
How often should Artelac™ Rebalance be used?
Instill one drop of Artelac™ Rebalance into the eye. It may be used daily whenever needed. Once opened, the product can be used for up to 2 months.
How should I use Artelac™ Rebalance?
It is recommended to wash your hands before using Artelac™ Rebalance.
Open the eye drop bottle cap. Tilt your head slightly backward and hold the bottle vertically above the eye (without touching the eye). Gently pull down the lower eyelid with the index finger of your other hand. Squeeze the bottle to apply one drop into the lower conjunctival sac.
Close your eye and slowly move your eyeball from side to side to ensure optimal distribution of the drop across the eye surface.
Repeat the procedure for the other eye if necessary and close the bottle again after use.
Additional Information
When should Artelac™ Rebalance not be used?
Do not use this product if you are hypersensitive to any of its ingredients.
Important information regarding the use of Artelac™ Rebalance
Local hypersensitivity reactions have been reported very rarely. In such cases, treatment should be discontinued. If you experience persistent discomfort or irritation, stop using the product and consult your doctor.
Do not touch the eye surface or contact lens with the tip of the bottle to avoid possible injury to the eye surface, damage to the contact lens, or contamination of the solution.
Do not touch the bottle tip with your fingers to prevent contamination of the solution.
Do not share the bottle with anyone after opening.
If you use more than one eye preparation, wait approximately 15 minutes between applications.
Discard the medical device 2 months after opening.
Do not use after the expiry date.
Before first use, check that the bottle is intact. Do not use if the bottle is damaged.
Artelac™ Rebalance contains small plastic parts that may be swallowed by young children. Choking hazard. Therefore, Artelac™ Rebalance should be kept out of the reach of children.
This device may be used by non-professionals who have not received special training.
Consult a physician before using Artelac™ Rebalance in children, during pregnancy, or while breastfeeding.
This product contains boric acid. Safety assessments of boric acid and sodium borate have concluded that they are not harmful at the concentrations used in this ophthalmic product.
How should Artelac™ Rebalance be stored?
Store at temperatures between 2°C and 25°C. Protect from sunlight.
Disposal
The product should be disposed of as waste in accordance with local regulations.
Any serious incident occurring in relation to the product should be reported to the manufacturer and the competent authority. Country-specific information can be found at www.bausch.com/contactus.
Packaging
Artelac™ Rebalance is supplied in 10 mL eye drop bottles.
Medical Device, Class IIb.
Notified Body: CE 0483 (mdc).
Manufacturer
Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165/173
13581 Berlin
Germany
