Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lysozyme (lysozyme hydrochloride), cetylpyridinium (cetylpyridinum chloride)
Bosnalijek d.d.
RO2AA20
lysozyme (lysozyme hydrochloride), cetylpyridinium (cetylpyridinum chloride)
20mg+ 1,5mg
lozenges compressed
(20/2x10/) in blister
OTC
Registered
2023-05-25
1. NAME OF THE MEDICINAL PRODUCT LYSOBACT DUO 20 mg/1,5 mg compressed lozenges _lysozyme, cetylpiridine_ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION LYSOBACT DUO contains: Lysozyme hydrochloride 20 mg (corresponding to 800 000 FIP units) Cetylpyridinium chloride 1.5 mg Excipients with known effect: sorbitol (E420) For the full list of excipients see part 6.1. 3. PHARMACEUTICAL FORM Compressed lozenge. White to almost white, round, biconvex compressed lozenge. 4.1.CLINICAL PARTICULARS 4.2. THERAPEUTIC INDICATIONS Local treatment of acute inflammatory diseases of the mouth cavity and pharynx (stomatitis, gingivitis, aphthae). Auxiliary treatment in laryngitis or pharyngitis. With doctor’s recommendation, preoperative and postoperative in tonsillectomy, larynx surgery, injuries or abscesses and after dental extraction. 4.3.POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE _Adults and children above 6 years of age_: 3-6 lozenges per day, with minimum 2 h intervals between dosages. 1.3.1 Summary of Product Characteristics SmPCD004821/1 LYSOBACT DUO 20 mg /1.5 mg compressed lozenges Page: 1 / 5 _Children under 6 years of age:_ LYSOBACT DUO is not intended to be used in children under 6 years of age. METHOD OF ADMINISTRATION Compressed lozenge should be slowly dissolved in the mouth, best under the tongue. 4.4.CONTRAINDICATIONS Hypersensitivity to lysozyme hydrochloride, cetylpiridinium chloride or to any of the excipients. Hypersensitivity to egg white. Children under 6 years of age. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE The indication does not justify an administration longer than 5 days. If the symptoms do not improve within 5 days and/or high body temperature occurs at the same time, you need to contact your doctor. Administration in patients with diabetes mellitus: the medicine is suitable for diabetic patients. Acute severe hypersensitivity reactions such as urticaria, angioedema (including the respiratory tract), bronchoconstriction, circulatory complications and anaphylactic shock ma Прочитать полный документ