Descriptive sheet

XanterNet

OPHTHALMIC GEL

Transparent sterile ophthalmic gel without preservatives containing sodium hyaluronate, xanthan gum and netilmicin 0.3%. Medical device indicated for the treatment of wounds and abrasions of the ocular surface caused by traumatic events or following surgical interventions. The use of Xanternet is specific for those patients in whom, in the opinion of the doctor, there is a risk of infection.
Contains two natural polymers: hyaluronic acid and xanthan gum. Applied to the conjunctival fornix, Xanternet mixes with tears and forms a viscous and transparent bandage that, by reducing friction caused by eye movements and blinking, protects the surface of the eye, promoting the repair processes following wounds or abrasions.
Xanternet also contains netilmicin, a broad-spectrum aminoglycoside antibiotic useful for reducing the risk of bacterial infections.
The product does not contain preservatives.

Composition
Sodium hyaluronate; xanthan gum; netilmicin 0.3%; disodium phosphate dodecahydrate; sodium phosphate monobasic monohydrate; sodium citrate; purified water.

How to use
It is recommended to administer Xanternet into the conjunctival fornix at a dose of one drop 4 times a day, unless otherwise indicated by the doctor.
Instructions for use:
1. Before use, make sure the single-dose container is intact.
2. Detach the single dose from the strip.
3. Grasp the single-dose container by the base and shake downwards.
4. Open by rotating the top and pull.
5. Instill Xanternet avoiding the tip of the container coming into contact with the eye or any other surface.

Contraindications
Hypersensitivity to aminoglycosides or to other components of the product.

Precautions for use
Prolonged use of topical antibiotics may lead to the growth of resistant microorganisms.
If, after a reasonable period of time (5-7 days), the use of Xanternet viscous bandage does not lead to an improvement in the clinical picture or if irritation or manifestations of hypersensitivity occur, treatment should be discontinued and a specialist consulted.
In early childhood the product should be administered in cases of actual need and under the direct supervision of a doctor.

Interactions with other drugs or medical devices for ophthalmic use
No significant drug interactions have been reported with the ophthalmic use of Netilmicin. However, due to the physical properties of the gel, it is recommended not to administer other drugs or medical devices for ophthalmic use within 60 minutes of Xanternet administration.
The concomitant administration, even topical, especially if intracavitary, of other potentially nephrotoxic and ototoxic antibiotics may increase the risk of such effects.
An increase in the potential nephrotoxicity of some aminoglycosides has been reported following the subsequent or concomitant administration, which should be avoided, of other potentially nephrotoxic substances, such as cisplatin, polymyxin B, colistin, viomycin, streptomycin, vancomycin, other aminoglycosides and some cephalosporins (cephaloridine) or of potent diuretics such as ethacrynic acid and furosemide, due to their repercussions on the kidney.
In vitro, the association of an aminoglycoside with a beta-lactam antibiotic (penicillins or cephalosporins) can cause significant reciprocal inactivation. Even when an aminoglycoside and a penicillin-like antibiotic were administered by two different routes, a reduction in the half-life or plasma levels of the aminoglycoside occurred in patients with renal insufficiency and in some patients with normal renal function.

Other interactions
The product has been shown to be compatible with the simultaneous use of therapeutic contact lenses after PRK surgery.
The use of other types of contact lenses is not recommended until 60 minutes have passed since the application of Xanternet.

Pregnancy and breastfeeding
Preclinical studies attest to the absence of fetal toxicity with topical administration of Netilmicin due to the poor systemic absorption of the product. However, during pregnancy it should be administered in cases of real need and under the direct supervision of a doctor.
Aminoglycosides are excreted in breast milk, therefore, their intake during breastfeeding is not recommended.

Warnings
For topical ocular use only.
Keep out of reach of children.
The product must be used under the advice of a doctor.
Occasionally, mild, transient burning may occur.
Do not touch the tip of the open container or put it in direct contact with the eye.
Each single-dose container must be used immediately after opening; any residue must not be reused.
Do not use Xanternet after the expiration date.
Do not use Xanternet if the container is open or damaged.
Do not use Xanternet if it is not transparent.
Administration of Xanternet to children or people with limited abilities must be carried out by a responsible adult.

Conservation
Since Xanternet does not contain preservatives, each single-dose container should only be used immediately after opening.
After opening the sachet, the remaining single-dose containers must be used within 12 weeks.
Store at a temperature not exceeding 30°C.

Format
Pack of 20 single-dose containers.

CE mark registration number 0373

Cod. HA/NET GEL