Quốc gia: Nam Phi
Ngôn ngữ: Tiếng Anh
Nguồn: South African Health Products Regulatory Authority (SAHPRA)
Adcock
BETADINE* VAGINAL GEL SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): BETADINE* VAGINAL GEL COMPOSITION: Each gram contains: Povidone-iodine 100 mg, equivalent to 10 mg available iodine in an inert water-soluble base. PHARMACOLOGICAL CLASSIFICATION: A. 18.6 Vaginal Preparations PHARMACOLOGICAL ACTION: Povidone-iodine is a multivalent broad spectrum local antiseptic having bactericidal and fungicidal properties. The effect on vegetative cells of various bacteria and fungi is due to the liberation of free iodine from the complex. Many viruses, protozoa, yeasts, cysts and spores are also susceptible. INDICATIONS: Vaginitis due to: - 1. Candida albicans 2. Trichomonas vaginalis 3. Mixed infections 4. Non-specific infections. CONTRA-INDICATIONS: Sensitivity to povidone-iodine. This product is spermicidal and should not be used when conception is desired. Patients with a non-toxic nodular colloid goitre should not use povidone-iodine. WARNINGS: 1. Not to be used by persons who are allergic to iodine. 2. Not to be used in pregnancy or by lactating women. DOSAGE AND DIRECTIONS FOR USE: One applicatorful (withdraw to four gram mark) of BETADINE* VAGINAL GEL is inserted each night to be followed by morning douching for two weeks, or as directed by the physician. If further therapy is required, the prescribed regimen should be continued through the next two menstrual cycles, the patient being seen every two weeks. To ensure prompt relief of the presenting symptoms, it is recommended that the vagina and cervix are swabbed with BETADINE* DOUCHE (undiluted) on initial examination and on subsequent examinations. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Povidone-iodine sensitivity may develop in certain individuals. If irritation, redness, swelling or other signs of sensitivity occur, the Đọc toàn bộ tài liệu