ARTELAC ECTOIN sol 10ml
Please read these instructions for use carefully, as they contain important information on how to use this product. If you have any questions, please consult your pharmacist, physician, eye care specialist, or contact us.
Intended Purpose
Supportive treatment and prevention of the symptoms of allergic conjunctivitis, for the relief of inflamed and irritated eyes and for soothing hydration of the eyes.
What is Artelac Ectoin?
Artelac Ectoin is a medical device containing Ectoin®, a natural cell-protective molecule with anti-inflammatory and membrane-stabilizing properties, and hyaluronic acid, a natural molecule that soothes the eyes thanks to its excellent water-binding and stabilizing characteristics.
It is free from buffers. The improved formulation is characterized by very high tolerability because it contains no preservatives.
Indications
Artelac Ectoin is an isotonic eye drop solution that can be used for the treatment and prevention of symptoms of seasonal and perennial allergic conjunctivitis caused by pollen, dust mites, animal hair, molds, and other allergens.
Symptoms such as itching, irritation, redness, and watery eyes are effectively reduced. The soothing moisturizing effect provides relief even for inflamed and irritated eyes.
Artelac Ectoin reduces conjunctival inflammation caused by physico-chemical irritants through a non-pharmacological mechanism.
When should Artelac Ectoin be used?
Artelac Ectoin stabilizes the natural tear film in two ways: hyaluronic acid has a positive effect on the aqueous layer, while Ectoin® strengthens the lipid layer. This dual mode of action protects the eyes against the harmful effects of allergens and other external factors and supports the regeneration process of irritated and sensitive conjunctival tissue.
Artelac Ectoin contains no preservatives and is suitable for contact lens wearers and people with sensitive eyes.
Composition
0.24% hyaluronic acid (as sodium hyaluronate)
2% Ectoin®
Sodium chloride
Sodium hydroxide (for pH adjustment)
Water for injections
Directions for Use
How often and for how long should Artelac Ectoin be used?
Instill 1–2 drops of Artelac Ectoin into the eye as needed. It may be used daily and as frequently as desired. There are no restrictions regarding the duration of use.
How should Artelac Ectoin be used?
The patented pump mechanism of Artelac Ectoin allows the eye drop solution to remain preservative-free, but it may not resemble other eye drop bottles you have used before.
General Note
Wash your hands before each use. Do not allow the tip of the bottle to come into contact with your fingers or your eye in order to avoid contamination of the solution or injury to the eye.
Before each use, remove the translucent white protective cap from the bottle tip using a twisting motion.
Attention! Before first use, or if the bottle has not been used for some time, hold the bottle with the tip facing downward and repeatedly press the pump mechanism until a drop is released.
Hold the bottle as illustrated: place your thumb on the ergonomic thumb support and grip the lower part of the bottle with your fingers. Two fingers should be positioned on the bottom of the bottle.
Point the bottle tip downward. Tilt your head slightly backward. Gently pull down the lower eyelid with a finger of your free hand. Hold the bottle vertically above the eye as shown. Carefully press the pump mechanism to dispense one drop into the eye.
Close your eye after application and blink to distribute the drop evenly across the eye surface.
Immediately after use, shake any residual drops from the bottle and replace the translucent white protective cap.
Due to the bottle design, a small amount of solution remains inside the bottle. However, the specified fill volume can be fully dispensed from the bottle.
Additional Information
When should Artelac Ectoin not be used?
Do not use this product if you are hypersensitive to any of its ingredients.
Important Information Regarding the Use of Artelac Ectoin
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 physician.
Please note that before first use or after a period of non-use, the pump mechanism must be primed. During priming, the bottle should be held with the dropper tip facing downward.
This product may cause temporary blurred vision after application, which may negatively affect the ability to drive vehicles or operate machinery.
Do not touch the eye surface with the bottle tip to avoid possible injury to the eye surface 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.
Improper handling of the product contrary to the instructions for use may cause the bottle to slip from your hand and result in eye injury.
Shake any residual drops from the bottle after application.
Wait approximately 15 minutes before using another eye product.
Discard the medical device 6 months after opening.
Do not use after the expiry date.
Do not use if the packaging or bottle is damaged.
Artelac Ectoin contains small plastic parts (protective cap) that may be swallowed by young children. Choking hazard. Therefore, Artelac Ectoin should be kept out of the reach of children.
Artelac Ectoin is suitable for use with both soft and hard contact lenses.
This device may be used by non-professionals without special training.
Based on current data, the product may be used during pregnancy, breastfeeding, and in children. If your child suffers from dry eyes, consult a physician before using an eye lubricant.
Storage
Store at a temperature between 2°C and 25°C. The bottle design allows Artelac Ectoin to be used for up to 6 months after opening.
Disposal
The product should be disposed of in accordance with local regulations.
Any serious incident occurring in relation to the product should be reported to the manufacturer and the competent authorities.
Packaging
Artelac Ectoin is available 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
