Descriptive sheet XanterDES
Description
Sterile wetting and lubricating ophthalmic solution.
XANTERDES is indicated to relieve discomfort and eye irritation due to environmental factors such as dust, heat, smoke, wind, air conditioning, allergens.
XANTERDES also contains a low concentration of a corticosteroid, desonide sodium phosphate, which supports the action of the medical device against mild irritation of the ocular surface.
XANTERDES has a moistening and lubricating action on the surface of the eye thanks to the presence of a natural polymer, xanthan gum.
XANTERDES, after application in the conjunctival sac, integrates with the tear, restoring normal lubrication of the ocular surface.
XANTERDES can also be used by contact lens wearers, taking care to remove them before administering the product and waiting 10 minutes before reinserting them.
How to use
It is recommended to instill 1 drop of XANTERDES into the conjunctival fornix three times a day, unless otherwise indicated by the doctor.
1. Before use, make sure the single-dose container is intact.
2. Detach the single dose from the strip.
3. Open by rotating the top part without pulling.
4. Instill XANTERDES avoiding the tip of the container coming into contact with the eye or any other surface.
Components
Xanthan gum 0.2%, desonide sodium phosphate 0.025%, sodium phosphate monobasic monohydrate, disodium phosphate dodecahydrate, sodium citrate, purified water.
Without preservatives.
Warnings
Keep out of the sight and reach of children.
Hypersensitivity to any of the product's components; ocular hypertension and glaucoma, ocular infections (such as herpes simplex infections, corneal viruses, bacterial, viral, or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, styes); presence of corneal lesions or abrasions; conditions associated with corneal thinning.
The product contains low concentrations of corticosteroids and therefore should not be used chronically unless otherwise directed by a physician. Very rarely, cases of corneal calcification have been reported in association with the use of phosphate-containing eye drops in some patients with significant corneal damage. The use of corticosteroids, especially if prolonged, can cause an increase in intraocular pressure. It is therefore advisable to monitor intraocular pressure if corticosteroids are used for more than two weeks. Since corticosteroids also promote the development of cataracts, it is advisable not to use them for long periods of time.
In early childhood and during pregnancy, the product should be administered only when strictly necessary and under medical supervision.
Occasionally, burning of the eyes may occur after instillation.
Do not touch the tip of the opened container or bring it into direct contact with the eye. Use the product immediately after opening. Any residue should not be reused because XANTERDES contains no preservatives and the remaining product could become contaminated.
Do not use XANTERDES after the expiration date. Do not dispose of the product in the environment after use. Administration of XANTERDES to children or people with limited ability must be performed by a responsible adult.
For topical ocular use.
Conservation
After opening each foil pouch, the remaining single-dose containers should be stored inside the pouch to protect the product from light. Once the pouch is opened, the single-dose containers must be used within 28 days. Store below 25°C.
Format
20 vials of 0.3 ml.
Cod. SF 104-XNT/AT