Active ingredients: Netilmicin
NETTACIN COLLIRIO 0.3% Eye drops, solution
Why is Nettacin Eye Drops used? What is it for?
Pharmacotherapeutic group
Netilmicin is an aminoglycoside antibiotic.
Therapeutic indications
Topical treatment of external eye infections and adnexa caused by germs sensitive to Netilmicin, including germs producing adenylating and phosphorylating enzymes.
Contraindications When Nettacin Collirio should not be used
Hypersensitivity to the components of the product or to other aminoglycosides.
Precautions for use What you need to know before taking Nettacin Collirio
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case, stop the treatment and consult the doctor to institute suitable therapy.
In very early childhood and pregnancy, the product should be administered in cases of real need and under direct medical supervision. It is not recommended to take it while breastfeeding.
NETTACIN COLLIRIO is not injectable; therefore it should not be injected subconjunctival or introduced into the anterior chamber.
Interactions Which drugs or foods can modify the effect of Nettacin Collirio
No significant drug interactions have been reported with the use of Netilmicin in eye drops.
The simultaneous topical administration, especially if intracavitary, of other potentially nephrotoxic and ototoxic antibiotics can increase the risk of these effects. An increase in the potential nephrotoxicity of some 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 some cephalosporins ( cephaloridine) or 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 a significant reciprocal inactivation. Even when an aminoglycoside and a penicillin-like antibiotic were administered through two different routes, a reduction in blood pressure occurred. half-life or plasma levels of the aminoglycoside in patients with renal insufficiency and in some patients with normal renal function.
Warnings It is important to know that:
Prolonged use of topical antibiotics can lead to the growth of resistant microorganisms. In the event that, after a reasonable period of time, no improvement in the clinical picture is obtained or if irritation or manifestations of hypersensitivity occur, treatment must be suspended and recourse. to adequate therapy.
Dosage and method of use How to use Nettacin Collirio: Dosage
Instill in the conjunctival sac one or two drops of eye drops 3 times a day or according to medical prescription.
Before use, make sure that the single-dose container is intact. NETTACIN COLLIRIO single-dose should only be used immediately after opening. Any residue must not be reused.
Avoid letting the tip of the container come into contact with the eye or any other surface.
Side Effects What are the side effects of Nettacin Eye Drops
NETTACIN COLLIRIO can cause the onset of mild and temporary eye irritation or hypersensitivity phenomena characterized by edema, urticarial eruptions and itching.
Patients are asked, if undesirable effects not described in the package leaflet occur, to notify their doctor or pharmacist.
Expiry and Retention
For the expiry date, see the packaging.
Warning: do not use the medicine after the expiry date indicated on the package.
Store below 25 ° C
NETTACIN COLLIRIO in multidose pack should not be used after 28 days from first opening.
NETTACIN COLLIRIO in single-dose packaging should only be used immediately after opening. Any residue must not be reused.
OPHTHALMIC USE
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
Deadline "> Other information
Composition
Multi-dose eye drops
100 ml contain:
Active ingredient: Netilmicin sulphate g 0.455 equal to Netilmicin g 0.300
Excipients: Sodium chloride - Benzalkonium chloride - Purified water
Single-dose eye drops
100 ml contain:
Active ingredient: Netilmicin sulphate g 0.455 equal to Netilmicin g 0.300
Excipients: Sodium chloride - Purified water
Pharmaceutical form and content
Eye drops, solution in 5 ml bottle
Eye drops, solution 15 single-dose containers of 0.3 ml
Eye drops, solution 20 single-dose containers of 0.3 ml
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
NETTACIN®
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
100 ml contain:
netilmicin sulphate g 0.455 equal to netilmicin g 0.300
03.0 PHARMACEUTICAL FORM -
Eye drops, solution.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Topical treatment of external eye infections and adnexa caused by germs sensitive to Netilmicin, including germs producing adenylating and phosphorylating enzymes.
04.2 Posology and method of administration -
Instill in the conjunctival sac one or two drops of eye drops 3 times a day or according to medical prescription.
Before use, make sure that the single-dose container is intact.
Nettacin Single-dose eye drops should only be used immediately after opening. Any residue should not be reused.
Avoid letting the tip of the container come into contact with the eye or any other surface.
04.3 Contraindications -
Hypersensitivity to the components of the product or to other aminoglycosides.
04.4 Special warnings and appropriate precautions for use -
Prolonged use of topical antibiotics can lead to the growth of resistant microorganisms. In the event that, after a reasonable period of time, no improvement in the clinical picture is obtained or if irritation or manifestations of hypersensitivity occur, treatment must be suspended and recourse. to adequate therapy.
In very early childhood, the product should be administered in cases of real need and under the direct supervision of the doctor.
NETTACIN® Collirio is not injectable, therefore it should not be administered subconjunctival or introduced into the anterior chamber.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction -
No significant drug interactions have been reported with the use of Netilmicin in eye drops.
The simultaneous topical administration, especially if intracavitary, of other potentially nephrotoxic and ototoxic antibiotics can increase the risk of these effects. An increase in the potential nephrotoxicity of some 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 some cephalosporins ( cephaloridine) or potent diuretics such as ethacrynic acid and furosemide, due to their repercussions on the kidney.
In vitro, the combination 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 through two different routes, a shortened half-life occurred. or plasma levels of the aminoglycoside in patients with renal insufficiency and in some patients with normal renal function.
04.6 Pregnancy and breastfeeding -
Despite the preclinical studies attest the absence of fetal toxicity with the topical administration of Netilmicin, due to the poor systemic absorption of the product, during pregnancy the product must be administered in cases of real need and under the direct supervision of the doctor.
Aminoglycosides are excreted in breast milk. Therefore, it is not recommended to take it while breastfeeding.
04.7 Effects on ability to drive and use machines -
NETTACIN® Eye Drops does not interfere with the ability to drive and use machines.
04.8 Undesirable effects -
Occasionally NETTACIN® Collirio can give rise to slight and temporary eye irritation or hypersensitivity phenomena characterized by edema, urticarial eruptions and itching.
04.9 Overdose -
No cases of overdose have ever been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Netilmicin is a broad spectrum semi-synthetic aminoglycoside antibiotic. It is active, at low concentrations, against various Gram negative and Gram positive pathogenic bacteria, including gentamicin-resistant strains. Unlike gentamicin, the antibiotic is in fact insensitive to the action of inactivating, phosphorylating and adenylating bacterial enzymes.
Netilmicin exerts a rapid bactericidal effect, causing errors in the translation of the mRNA and therefore the insertion of the wrong amino acids in the polypeptide chain in formation.
05.2 "Pharmacokinetic properties -
The instillation of NETTACIN® eye drops at the level of the conjunctival fornix is followed by poor topical and systemic absorption.
Following intramuscular administration of a dose of 2 mg / ml, maximum plasma concentrations of netilmicin of 5 mcg / ml are achieved after 30 - 60 minutes. After an intravenous infusion over 60 minutes, maximum plasma concentrations of approximately 11 mcg / ml are obtained. In adults, the half-life is 2.0 - 2.5 hours; this value increases in the presence of renal insufficiency.
05.3 Preclinical safety data -
Preclinical studies conducted on rats, dogs, guinea pigs, cats, rabbits and monkeys confirm the excellent tolerability of the product, which proved to be less nephrotoxic and ototoxic than the other aminoglycosides.
The DL50 via i.m. and i.p. was found to be respectively 142 and 186 mg / kg in mice, 166 and 266 mg / kg in rats and 160
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Multi-dose eye drops:
Sodium chloride, benzalkonium chloride, purified water.
Single-dose eye drops:
Sodium chloride, purified water.
06.2 Incompatibility "-
Not known.
06.3 Period of validity "-
Multi-dose eye drops:
In intact packaging: 36 months.
After first opening: 28 days.
Single-dose eye drops:
In intact packaging: 24 months.
NETTACIN® single-dose eye drops should only be used immediately after opening. Any residue should not be reused.
06.4 Special precautions for storage -
Store below 25 ° C.
06.5 Nature of the immediate packaging and contents of the package -
Multi-dose eye drops:
Low density polyethylene bottle with a capacity of 5 ml.
Single-dose eye drops:
15 single-dose containers in low density polyethylene of 0.3 ml
20 single-dose containers in low density polyethylene of 0.3 ml
06.6 Instructions for use and handling -
Multi-dose eye drops:
Screw the cap all the way in to pierce the bottle.
Unscrew the cap, turn the bottle upside down and instill by exerting a slight pressure on it.
Close the bottle by screwing the cap all the way down.
Single-dose eye drops:
Detach the single-dose from the strip.
Open by turning the top without pulling.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
S.I.F.I. S.p.A. - Via Ercole Patti, 36 - 95020 Lavinaio - Aci S. Antonio (CT)
08.0 MARKETING AUTHORIZATION NUMBER -
NETTACIN® 5 ml eye drops: 027204015
NETTACIN® eye drops 15 single-dose containers: 027204027
NETTACIN® eye drops 20 single-dose containers: 027204039
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
01/12/2001
10.0 DATE OF REVISION OF THE TEXT -
01/07/2003
