Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
cetylpyridinium (cetylpyridinium chloride), benzocaine
KRKA d.d.
cetylpyridinium (cetylpyridinium chloride), benzocaine
2mg/ml+10mg/ml
spray
OTC
Summary of product characteristics CONFIDENTIAL 1.3.1 Benzocaine + Cetylpyridinium chloride SPC, Labeling and Package Leaflet AM SmPCPIL049225_2 – Updated: 02.04.2014 Page 1 of 6 1. NAME OF THE MEDICINAL PRODUCT Septolete plus 10 mg/2 mg oromucosal spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oromucosal spray contains 10 mg benzocaine and 2 mg cetylpyridinium chloride. Excipient: - ethanol (96 per cent): 330 mg/ml of spray For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal spray. Oromucosal spray appears as clear, colourless to yellowish solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Septolete plus oromucosal spray is recommended for symptomatic relief of throat pain: - in milder infections in the oral cavity and throat (pharyngitis, laryngitis), - in inflammation of the gums and oral mucous membrane (stomatitis, gingivitis), - in cold and flu. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS AND ADOLESCENTS OVER 12 YEARS OF AGE: For a single dose, the spray head should be pressed TWICE. This may be repeated every 2 to 3 hours, up to 8 times a day. CHILDREN 6 TO 12 YEARS OF AGE: For a single dose, the spray head should be pressed ONCE. This may be repeated every 2 to 3 hours, up to 8 times a day. Children should be supervised by an adult when using the spray. Septolete plus is not recommended for use in children under 6 years of age due to insufficient data on safety (please see section 4.4.). Septolete plus should not be used for more than 7 consecutive days. METHOD OF ADMINISTRATION Before the first use of Septolete plus or if Septolete plus has not been used for a long period of time, press the spray head several times (5 to 9 times) and release some of the medicine into the air or sink. Keep pressing until a fine spray appears. CONFIDENTIAL 1.3.1 Benzocaine + Cetylpyridinium chloride SPC, Labeling and Package Leaflet AM SmPCPIL049225_2 – Updated: 02.04.2014 Page 2 of 6 Remove the plastic cap before use. Open your mouth wide, point the spray noz Đọc toàn bộ tài liệu