Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lidocaine (lidocaine hydrochloride), neomycin (neomycin sulfate), polymyxin B (polymyxin B sulfate)
Zambon S.P.A.
առկա չէ (S02)
lidocaine (lidocaine hydrochloride), neomycin (neomycin sulfate), polymyxin B (polymyxin B sulfate)
4g/100ml+ 0.5g(375000IU)/100ml+ 1000000IU/100ml
drops ear
25ml glass bottle
Prescription
Registered
2021-04-13
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ANAURAN EAR DROPS, SOLUTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml of solution contain: ACTIVE INGREDIENTS Polymyxin B sulfate 1000000 I.U. Neomycin sulfate (equivalent to base neomycin 0.500 g 375000 I.U.) 4.1 THERAPEUTIC INDICATIONS Acute and chronic otitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION - Adults: 4-5 drops, 2-4 times daily; - Children: 2-3 drops, 3-4 times daily. Instill the drops, by means of the appropriate dropper, into the external auditory canal while bending the head to one side for some minutes. The treatment duration depends on the promptness of the therapeutic response,it is recommended not use the medicine more than 10 consecutive days. 4.3 CONTRAINDICATIONS ANAURAN is contraindicated: - in patients with hypersensitivity to Polymixin B sulfate, to Neomycin sulfate and to Lidocaine hydrochloride and any of the product ingredients and to other chemically strictly related substances. - in patients who present the perforated tympanic membrane, due to the risk of ototoxicity. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The use, especially if prolonged, of topical preparations may cause sensitization phenomena. In this case it is necessary to discontinue the treatment and consult the physician, in order to adopt an adequate therapy. In the presence of deep or resistant infections, it is appropriate to integrate the local medication with adequate antibiotic therapies by general route. As for other antibiotic preparations, prolonged treatment may result in superinfection by resistant germs. Lidocaine hydrochloride 4 g 3. PHARMACEUTICAL FORM Ear drops. 4. CLINICAL PARTICULARS 2 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Incompatible with monomycin, streptomycin, gentamycin, amikacyn, netilmycin due to the increased ototoxic effect 4.6 PREGNANCY AND LACTATION Pregnancy There are no adequate and well controlled studies in pregnant women. The preparation should be used in pregnant wome Прочитать полный документ