Country: Հայաստան
language: անգլերեն
source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
povidone-iodine
Alkaloid AD-Skopje
G01AX11
povidone-iodine
200mg
suppositories vaginal
(14/2x7/)
OTC
Registered
2021-05-25
BETADINE ® 200 mg vaginal suppositories _Module 1.3.2 Summary of Product Characteristics _ 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT BETADINE ® 200 mg vaginal suppositories 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vaginal suppository contains 200 mg of povidone-iodine, equivalent to 20 mg of available iodine. _ _ EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM vaginal suppository Dark brown to red, bullet-shaped pessary. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Betadine vaginal suppositories are indicated for acute and chronic vaginal infections (vaginitis) caused by mixed infections, non-specific infections, Trichomonas vaginalis infections and mycotic (Candida albicans) infections, especially after antibiotic or steroid therapy. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Once a day, at bedtime, in lying position, insert previously water-wetted vaginal pessary deeply into the vagina. Unless the doctor prescribes otherwise, usual therapy lasts 14 days, in any time of the menstrual cycle, including the days of menstrual bleedings. Since leaking of the medicine out of the vagina can not always be prevented, sanitary pads, but not tampons are recommended. This medicine is not intended for use in pre-pubertal children. 4.3. CONTRAINDICATION Betadine vaginal suppositories are contraindicated in: known hypersensitivity to iodine; hyperthyroidism; dermatitis herpetiformis; before and after radioiodotherapy. BETADINE ® 200 mg vaginal suppositories _Module 1.3.2 Summary of Product Characteristics _ 2 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Regular or prolonged use of povidone-iodine should be avoided in patients on lithium therapy, renal failure and thyroid disease. Povidone-iodine is not recommended for use in patients with renal failure due to the potential for metabolic acidosis and nephrotoxicity. Povidone-iodine is also not recommended for use in patients with hepatic failure. Betadine vaginal read_full_document