Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
CHLORHEXIDINE GLUCONATE
Ecolab Limited
A01AB03
CHLORHEXIDINE GLUCONATE
0.2 %w/v
Oromucosal Solution
Product not subject to medical prescription
chlorhexidine
Marketed
2000-02-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Chlorhexidine Gluconate Antiseptic Mouthwash Original Flavour 0.2% w/v Oromucosal Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Gluconate 0.2% w/v. Excipients: Ponceau 4R 0.001%w/w Macrogol glycerol hydroxystearate 0.7% w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oromucosal Solution. A clear pink solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chlorhexidine Gluconate Antiseptic Mouthwash is an antimicrobial solution which inhibits the formation of dental plaque. It is indicated as an aid to the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (eg following oral surgery or in physically handicapped patients). It is used to promote gingival healing following periodontal surgery, to manage recurrent oral ulceration. Additionally it is useful in the treatment of denture stomatitis and thrush. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Children, adults and the elderly._ Chlorhexidine Gluconate Antiseptic Mouthwash should be used as required up to twice daily. Rinse the mouth thoroughly for about 1 minute with 10 ml. Prior to dental surgery, the patient should be instructed to rinse the mouth with 10 ml for 1 minute. In the treatment of gingivitis a course of about one month is recommended (ie two bottles). For denture stomatitis cleanse and soak the denture in solution for 15 minutes twice daily. In the case of aphthous ulceration and oral candidal infections, treatment should be continued for 48 hours after clinical resolution. 4.3 CONTRAINDICATIONS Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Chlorhexidine Gluconate Antiseptic Mouthwash contains chlorhexidine. Chlorhexidine is known to induce hypersensitivi Đọc toàn bộ tài liệu