Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Seton Healthcare Group PLC
10%w/v %w/v
Vaginal Solution
1993-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Vaginal Cleansing Kit. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Povidone Iodine 10% w/v For excipients, see 6.1. 3 PHARMACEUTICAL FORM Concentrate for vaginal solution A dark brown coloured solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic for use in the management of pre-operative disinfection of vaginitis due to organisms sensitive to the iodine and in pre-operative preparation of the vagina. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For intravaginal administration. Betadine Vaginal Cleansing concentrate should be diluted 1:10 and used according to the patient instruction leaflet provided. Use once a day (preferably in the morning) for 14 consecutive days. If menstruation occurs during the treatment it is important to continue treatment during the days of the period. 4.3 CONTRAINDICATIONS 1. Use in patients hypersensitive to iodine. 2. Use in pregnancy. 3. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis). 4. Use in pre-pubertal children 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 1. If local irritation, redness or swelling develops discontinue treatment. Iodine is absorbed from the vagina and following prolonged use, thyroid dysfunction may develop. The product may be spermicidal and should not be used when conception is desired. 2. If no improvement occurs the doctor should be consulted. 3. Special caution is needed when regular applications to inflamed or broken vaginal mucosa are made to patients with pre existing renal insufficiency. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 24/10/2005_ _CRN 2016032_ _ Прочитајте комплетан документ