Nettacin eye drops

Package leaflet

NETTACIN EYE DROPS 0.3%

Eye drops, solution
Netilmicin
Composition
Multi-dose eye drops
100 ml contains:
Active substance: Netilmicin sulfate 0.455 g equivalent to Netilmicin 0.300 g
Excipients: Sodium chloride - Benzalkonium chloride - Purified water
Single-dose eye drops
100 ml contains:
Active substance: Netilmicin sulfate 0.455 g equivalent to Netilmicin 0.300 g
Excipients: Sodium chloride - Purified water
Pharmaceutical form and contents
Eye drops, solution in 5 ml bottle
Eye drops, solution: 15 single-dose units of 0.3 ml
Eye drops, solution: 20 single-dose units of 0.3 ml
Therapeutic category
Netilmicin is an aminoglycoside antibiotic.
Marketing Authorization Holder
S.I.F.I. S.p.A. - Registered office: via Ercole Patti, 36 - 95020 Lavinaio - Aci S. Antonio (CT)
Marketing Authorisation Holder
EYELAB S.R.L. – Via Ercole Patti, 36 - 95025 Aci S. Antonio (CT)
Manufacturer
S.I.F.I. S.p.A. - Aci S. Antonio (CT) facility
Therapeutic indications
Topical treatment of external ocular infections and adnexa caused by microorganisms sensitive to netilmicin, including those producing adenylating and phosphorylating enzymes.
Contraindications
Hypersensitivity to the components of the product or to other aminoglycosides.
Precautions for use
The use, especially if prolonged, of topical products may lead to sensitization phenomena. In such cases, discontinue treatment and consult a physician to initiate appropriate therapy.
In early infancy and during pregnancy, the product should be administered only when clearly necessary and under direct medical supervision. Use during breastfeeding is not recommended.
NETTACIN EYE DROPS are not for injection; therefore, they must not be administered via subconjunctival injection or introduced into the anterior chamber.
Drug interactions
No significant drug interactions have been reported with the use of netilmicin in eye drops.
Concomitant administration, even topical and especially if intracavitary, of other potentially nephrotoxic and ototoxic antibiotics may increase the risk of such effects. An increased potential nephrotoxicity of certain aminoglycosides has been reported following 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 certain cephalosporins (cephaloridine), or potent diuretics such as ethacrynic acid and furosemide, due to their effects on the kidney.
In vitro, the combination of an aminoglycoside with a beta-lactam antibiotic (penicillins or cephalosporins) may cause mutual and significant inactivation. Even when an aminoglycoside antibiotic and a penicillin-like antibiotic have been administered via different routes, a reduction in the half-life or plasma levels of the aminoglycoside has occurred in patients with renal impairment and in some patients with normal renal function.
Special warnings
Prolonged use of topical antibiotics may lead to overgrowth of resistant microorganisms. If, after a reasonable period of time, no clinical improvement is observed, or if irritation or hypersensitivity reactions occur, treatment should be discontinued and appropriate therapy initiated.
Dosage, method and duration of administration
Instill one or two drops into the conjunctival sac three times daily, or as directed by a physician.
Before use, ensure the single-dose container is intact.
NETTACIN SINGLE-DOSE EYE DROPS must be used immediately after opening. Any remaining solution must not be reused.
Avoid contact of the container tip with the eye or any other surface.
Undesirable effects
NETTACIN EYE DROPS may cause mild and transient ocular irritation or hypersensitivity reactions such as edema, urticarial eruptions, and pruritus.
Patients are advised to inform their physician or pharmacist if any adverse effects not described in this leaflet occur.
Expiry date
Refer to the packaging for the expiry date.
Warning: Do not use the medicine after the expiry date stated on the packaging.
Store below 25 °C.
NETTACIN MULTI-DOSE EYE DROPS must not be used more than 28 days after first opening.
NETTACIN SINGLE-DOSE EYE DROPS must be used immediately after opening. Any remaining solution must not be reused.
FOR OPHTHALMIC USE
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
Instructions for use
Multi-dose eye drops
Screw the cap fully on to pierce the bottle.
Unscrew the cap, invert the bottle, and instill drops by applying gentle pressure.
Close the bottle by screwing the cap fully back on.
Single-dose eye drops
Detach the single-dose unit from the strip.
Open by twisting the top part without pulling.