Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Povidone-iodine
Mundipharma Pharmaceuticals Limited
D08AG; D08AG02
Povidone-iodine
40 milligram(s)/millilitre
Cutaneous solution
Iodine products; povidone-iodine
Not marketed
1975-11-25
Health Products Regulatory Authority 09 July 2019 CRN0091J5 Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Skin Cleanser 40mg/ml cutaneous solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 40 mg povidone iodine. For excipients see Section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Solution. Golden brown, clear viscous liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the disinfection and cleansing of skin in the management of superficial infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply to thoroughly wet skin, then rinse, twice daily or as directed by a physician. 4.3 CONTRAINDICATIONS Use in patients with hypersensitivity to iodine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use of the preparation may interfere with tests of thyroid function. If there is aggravation of the condition or no improvement consult the doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None stated. 4.6 FERTILITY, PREGNANCY AND LACTATION Regular use of povidone-iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Use of this preparation may interfere with tests of thyroid function. 4.9 OVERDOSE Health Products Regulatory Authority 09 July 2019 CRN0091J5 Page 2 of 3 In the case of accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte imbalance and renal and thyroid function. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES D08AG02-Antiseptics and disinfectants Betadine Skin Cleanser contains povidone-iodine, a complex of iodine which shows all the broad spectrum germicidal activity of elemental iodine. 5.2 PHARMACOKINETIC PROPERTIES Not applicable. 5.3 PRECLINICAL SAFETY DATA Not applicable. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Potass Izlasiet visu dokumentu