ࡱ> []Z 0KMbjbj ;N4n 8D#d>!o"`S>U>U>U>U>U>U>@tCLU>9"@""U>>'''"\RS>'"S>'';q"'=V||+%k<?>>0><C%C,'=C'=""'"""""U>U>'""">""""C""""""""" : SUMMARY OF PRODUCT CHARACTERISTICS Name of the medicinal product Netophtiole ophthalmic solution. Qualitative and quantitative composition of active substance Each 1 ml ophthalmic solution contains: 3 mg of netilmicin as netilmicin sulphate 4.55 mg Pharmaceutical form Ophthalmic solution. Clear colorless to pale yellow solution free from any visible particles. Clinical particulars Therapeutic indications Topical treatment of external infections of the eye and appendages caused by the germs susceptible to Netilmicin, including the germs producing adenylating and phosphorylating enzymes. Dosage and method of administration Instill one or two drops of eye drops in the conjunctival sac 3 times a day or as prescribed by a doctor. Contraindications Hypersensitivity to the components of the product or to other aminoglycosides. Special warnings and precautions for use Prolonged use of topical antibiotics can lead to the growth of resistant microorganisms. If no improvement is achieved in the clinical picture after a reasonable period of time, or if irritations or signs of hypersensitivity occur, treatment should be discontinued and appropriate therapy should be given. In the earliest childhood, the product should be administered in the case of need and under the direct supervision of the doctor. Netophtiole ophthalmic solution is not injectable; therefore it should not be administered subconjunctivally or introduced into an anterior chamber. Keep this medicine out of the reach of children. Aminoglycosides antibiotics may cause irreversible, partial or total deafness when given systemically or when applied topically to open wounds or damaged skin. This effect is dose related and is enhanced by renal or hepatic impairment. Although, this effect has not been reported following ocular use, the possibility should be considered when high dose topical is given to small children or infants. The course of treatment should generally be limited to 7 to 10 days. Netophtiole contains Benzalkonium chloride: May cause eye irritation Avoid contact with soft contact lenses Remove contact lenses prior to application and wait at least 15 minutes before reinsertion Known to discolour soft contact lenses Pharmacological interactions No significant drug interactions have been reported with the use of Netilmicin opthalmic solution. The simultaneous topical administration of other potentially nephrotoxic and ototoxic antibiotics may increase the risk of such effects, especially if it is intracavitary. It has been reported an increase in the potential nephrotoxicity of some aminoglycosides following the subsequent or simultaneous administration of other potentially nephrotoxic substances, such as cisplatin, polymyxin B, colistin, and viomycin, which should be avoided, streptomycin, vancomycin, other aminoglycosides and some cephalosporins (cephaloridine) or potent diuretics such as ethacrynic acid and furosemide, for the effects on the kidney. In vitro, the association of an aminoglycoside with a beta-lactam antibiotic (penicillins or cephalosporins) can cause a mutual and significant inactivation. Even when an aminoglycoside antibiotic and similar penicillin were administered via two different routes, the half-life or plasma levels of aminoglycoside reduced in patients with renal impairment and in some patients with normal renal function. Pregnancy and lactation Although preclinical studies demonstrate the absence of fetal toxicity with the topical administration of Netilmicin, the product should be administered during the pregnancy only if it is really required and under the direct supervision of the doctor. Aminoglycosides are excreted in breast milk. Therefore, it is not recommended for use during the lactation. Effects on ability to drive vehicles and use machines Netophtiole opthalmic solution does not interfere with the ability to drive and use machines. SIDE EFFECTS Occasionally Netophtiole ophthalmic solution may give rise to slight and temporary eye irritation or to hypersensitivity phenomena characterized by edema, urticarial rashes and pruritus. Overdose No cases of overdose have been reported to date. Pharmacological particulars Pharmacodynamic properties Netilmicin is a broad-spectrum semi-synthetic aminoglycoside antibiotic. It is active at low concentrations against several Gram-negative and Gram-positive pathogens, including gentamicin-resistant strains. In fact, unlike gentamicin, this antibiotic is not susceptible to the action of inactivating phosphorylating and adenylating bacterial enzymes. Netilmicin has a rapid bactericidal effect, causing errors in the translation of the mRNA and therefore the insertion of wrong amino acids in the polypeptide chain being formed. Pharmacokinetic properties The instillation of Netophtiole ophthalmic solution at the level of conjunctival fornix is followed by poor topical and systemic absorptions. Following the intramuscular administration of a dose of 2 mg/mL, maximum plasma concentrations of Netilmicin 5 g/ml are achieved after 30 to 60 minutes. After an intravenous infusion over 60 minutes, maximum plasma concentrations of about 11 g/mL are obtained. In adults, the half-life is 2.0 - 2.5 hours; this value increases in the presence of renal failure. Pharmaceutical particulars List of excipients Benzalkonium chloride - Sodium chloride Sodium hydroxide Sterile water. Incompatibility Not noted. Validity For unopened bottles: 2 years After first opening: used within 1 month when stored at temperature not exceeding 30C. Special precautions for storage Store at temperatures not exceeding 30C. Nature and contents of container Carton box contains round sterile white plastic bottle (LDPE) containing 5 ml solution, with sterile white dropper plug (LDPE) and sterile white screw cap (HDPE) and an insert leaflet. Instructions for use Screw the cap completely to pierce the bottle. Unscrew the cap, turn the bottle upside down and instill by gently pressing on it. Close the bottle by screwing the cap completely. 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