Descrizione Clinica
Eye drops Xanternet gel oft 20fl 0,4ml Sifi
XanterNet
GEL OFTALMICTransparent sterile ophthalmic gel without preservatives containing sodium hyaluronate, xanthan gum and netylmycin 0.3%. Medical device indicated for the treatment of wounds and abrasions of the eye surface caused by traumatic events or subsequent surgery. The use of Xanternet is specific to those patients where, in the opinion of the doctor, there is a risk of infection.
Contains two natural polymers: hyaluronic acid and xanthan gum. Applied in the conjunctive fork, Xanternet mixes with tear and forms a viscous and transparent bandage that, reducing friction caused by eye movements and embellishment, protects the eye surface by favoring repair processes resulting from wounds or abrasions.
Xanternet also contains netylmycin, a broad spectrum aminoglycoside antibiotic useful to reduce the risk of bacterial infections.
The product does not contain preservatives.
Composition
Hyaluronate sodium; xanthan gum; netilmycin 0.3%; disode phosphate dodecaidrate; sodium phosphate monobasic monohydrate; sodium citrate; purified water.
Mode of use
It is recommended to administer Xanternet in the joint furnace at the dose of a drop 4 times a day, unless otherwise indicated by the doctor.
Instructions for use:
1. Before use make sure that the single-dose container is intact.
2. Put the monodose off the strip.
3. Grab the monodose container from the base and shake down.
4. Open by turning the top and pull.
5. Instill Xanternet avoiding the end of the container to contact the eye or any other surface.
Contraindications
Hypersensitivity to aminoglycosides or to other product components.
Precautions of use
Prolonged use of topical antibiotics can lead to the growth of resistant microorganisms.
In case, after a reasonable period of time (5-7 days) the use of Viscous Xanternet bandages did not lead to an improvement of the clinical picture or if irritations or manifestations of hypersensitivity occur, the treatment should be stopped and consult the specialist.
In the early childhood the product should be administered in cases of actual need and under the direct control of the doctor.
Interactions with other medicines or medical devices for ophthalmic use
No significant drug interactions have been reported with the ophthalmic use of Netilmycin. However, for the physical properties of the gel, it is recommended not to administer other medicines or medical devices for ophthalmic use in 60 minutes after administration of Xanternet.
The contemporary administration also topical, especially if intracavious, of other potentially nephrotoxic and ototoxic antibiotics can increase the risk of such effects.
An increase in the potential nephrotoxicity of some aminoglycosides has been reported as a result of the subsequent or contemporary administration, which should be avoided, of other potentially neurotoxic substances, such as cisplatin, polymixin B, colistina, viomicin, streptomycin, vancomycin, other aminoglycosides and some potent cephalosporins (cephauredine.
In vitro the association of an aminoglycoside with a betalatmic antibiotic (penicillin or cephalosporine) can cause a reciprocal and significant inactivation. Even when an aminoglycoside antibiotic and a penicillin-similar have been administered through two different ways, a reduction of the half-life or plasma levels of aminoglycoside in patients with kidney failure and in some patients with normal kidney function has occurred.
Other interactions
The product has proven to be compatible with the contemporary use of therapeutic contact lenses after PRK intervention.
We do not recommend the use of other types of contact lenses if there have not been 60 minutes since the application of Xanternet.
Pregnancy and nursing
Preclinical studies attest the absence of fetal toxicity with the topic administration of Netilmicina for the poor systemic absorption of the product. However, in pregnancy it should be administered in cases of actual need and under direct control of the doctor.
Aminoglycosides are excreted in breast milk, therefore, we do not recommend taking them during breastfeeding.
Warnings
For exclusive topical eye use.
Keep out of reach of children.
The product should be used on medical advice.
Occasionally it can manifest mild and transitory burning.
Do not touch the end of the open container and do not put it in direct contact with the eye.
Each single-dose container should be used immediately after opening, any residue should not be reused.
Do not use Xanternet after the expiry date.
Do not use Xanternet if the container is open or damaged.
Do not use Xanternet if it is not transparent.
The administration of Xanternet to children or persons with limited skills must be carried out by a responsible adult.
Conservation
As Xanternet does not contain preservatives, each single-dose container should be used only immediately after opening.
After opening the envelope, the remaining monodose containers must be used within 12 weeks.
Store at temperature not exceeding 30 °C.
Format
Pack of 20 single-dose containers.
CE mark registration number0373
Cod. HA/NET GEL