Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lysozyme (lysozyme hydrochloride), pyridoxine (pyridoxine hydrochloride)
Bosnalijek d.d.
R02AА20
lysozyme (lysozyme hydrochloride), pyridoxine (pyridoxine hydrochloride)
20mg+ 10mg
lozenges compressed
(10/1x10/) in blister, (30/3x10/) in blister
OTC
Registered
2023-03-21
1. TRADE NAME OF THE MEDICINAL PRODUCT LYSOBACT ® compressed lozenges INN: Lysozyme hydrochloride, pyridoxine hydrochloride. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each LYSOBACT compressed lozenge contains: Active ingredient: Lysozyme hydrochloride 20.00 mg Pyridoxine hydrochloride 10.00 mg For excipients, see 6.1. 3. PHARMACEUTICAL FORM White or yellowish-white, circular lozenges with a diameter of approximately 8 mm, scored on one side, with bevelled edges on both sides. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS LYSOBACT is indicated for the treatment of infectious-inflammatory diseases of the oral, gingival, and laryngeal mucous membrane: gingivitis, stomatitis, acute upper respiratory tract infections at multiple or unspecified sites (acute laryngopharyngitis, other acute upper respiratory tract infections at multiple sites, unspecified acute upper respiratory tract infection), aphthous ulcers, herpetic lesions (as part of a complex therapy regimen), and erosion of the oral mucosa of any origin. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The product is for topical administration. The compressed lozenges should be slowly dispersed in the mouth without chewing, the melting substance of the compressed lozenge should be retained in the mouth as long as possible, until complete dissolution. For children aged 7 to 12 years: one compressed lozenge four times per day. For adults and children over 12 years of age: 2 compressed lozenges three or four times per day. A treatment course should last 8 days (or longer if necessary). 1.3.1 Summary of Product Characteristics SmPCD004647/1 LYSOBACT 20 mg/10 mg compressed lozenges Page: 1 / 5 1.3.1 Summary of Product Characteristics SmPCD004647/1 LYSOBACT 20 mg/10 mg compressed lozenges Page: 1 / 5 4.3. CONTRAINDICATIONS Hypersensitivity to any component of the medicinal product (including the egg white allergy) Age under 7 years Hereditary lactose intolerance; lactase deficiency or glucose - galactose malabsorption. 4.4. SPECIAL WARNINGS AND SPECIA Прочитать полный документ