Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
POVIDONE-IODINE
Seton Healthcare Group PLC
POVIDONE-IODINE
200mg Milligram
Pessary
Withdrawn
2006-07-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Vaginal Pessaries. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Povidone Iodine 200mg For excipients see section 6.1 3 PHARMACEUTICAL FORM Pessary Smooth dark-brown in colour and tapered. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an antiseptic in the management of vaginitis due to organisms sensitive to iodine and in pre-operative vaginal preparation 4.2 POSOLOGY AND METHOD OF ADMINSTRATION For intravaginal administration. Using the applicator, insert a pessary morning and night for up to 14 days. Each pessary should be wetted with water immediately prior to insertion, thus ensuring maximum dispersion of the active constituent and avoiding risk of local irritation. If menstruation occurs during treatment, it is important to continue treatment during the days of the period. 4.3 CONTRAINDICATIONS 1. Known or suspected iodine hypersensitivity. 2. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis). 3. 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. 4. Regular use should be avoided in patients on concurrent lithium therapy. IRISH MEDICINES BOARD ____________________________________________________________________________________________________________________ Прочитајте комплетан документ