Страна: Армения
Език: английски
Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
povidone-iodine
Arpimed LLC
D08AG02
povidone-iodine
75mg/ml
soap liquid
80ml and 140ml plastic bottle, 1l and 3l plastic container
OTC
Registered
2018-07-17
SUMMARY PRODUCT CHARACTERISTIC (SPC) BETAIODINE ® 7.5% LIQUID SOAP 1.NAME OF THE MEDICINAL PRODUCT – Betaiodine 2. INTERNATIONAL NON-PROPERTY NAME – Povidone Iodine 3. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Betaiodine, 7.5% liquid soap, contains: _ ACTIVE INGREDIENT: _povidone iodine – 75 mg. For a full list of excipients see section 6.1. 4. PHARMACEUTICAL FORM Liquid soap A brown colored liquid having a characteristic iodine odor. 5. CLINICAL PARTICULARS 5.1 THERAPEUTIC INDICATIONS BETAIODINE 7.5% Liquid soap is a broad-spectrum antiseptic for topical use. It is indicated for pre-operative hand disinfection by the surgical team, or for disinfecting the site of incision prior to elective surgery. 5.2 POSOLOGY AND METHOD OF ADMINISTRATION PRE-OPERATIVE SURGICAL SCRUB - after first wetting the hands and arms with water, approximately 3.5ml of BETAIODINE 7.5% Liquid soap is applied and rubbed thoroughly on to these areas. A brush may be used to scrub the nails. A little water is added to develop a lather and finally this MUST BE RINSED OFF with running water. PRE-OPERATIVE SKIN PREPARATION - the site of incision should be washed with BETAIODINE 7.5% Liquid soap two or three times a day prior to the operation. Immediately before surgery the skin should be moistened with water, BETAIODINE 7.5% Liquid soap applied and rubbed thoroughly into the area for several minutes. A sterile gauze swab is used to develop a lather which MUST BE FINALLY RINSED OFF with water. Only water should be used to dilute BETAIODINE 7.5% Liquid soap . _Neonates: _ Do not use on neonates, refer to Section 4.3 Contraindications. _Children and Elderly: _ There are no special dosage recommendations for children or elderly patients. _Renal Impairment: _ Patients with renal impairment should refer to Section 4.4, special warnings and precautions for use. 5.3 CONTRAINDICATIONS BETAIODINE 7.5% Liquid soap must never be administered orally, and is contra-indicated in neonates, and during pregnancy and lactation. Regular or prolonged Прочетете целия документ