Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
IODINATED POVIDONE PH.EUR.
Ecolab Limited
D08AG02
IODINATED POVIDONE PH.EUR.
10 %w/w
Cutaneous Solution
Product not subject to medical prescription
povidone-iodine
Marketed
2000-06-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Videne Antiseptic Solution 10% w/w Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of cutaneous solution contains 10%w/w iodinated povidone, equivalent to 11mg iodine. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution. A dark reddish brown mobile liquid with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FOR ONCE-ONLY USE: Disinfection of intact external skin or as a mucosal antiseptic, for example prior to surgery, biopsies, injections, punctures, blood-taking and bladder catheterisations. FOR REPEATED, TIME-LIMITED USE: Antiseptic wound treatment (eg, decubitus and varicose ulcers), burns, infected and superinfected dermatoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Videne Antiseptic Solution is intended for topical application either undiluted or diluted. Used as a disinfectant or an antiseptic for the skin or mucosa, eg, prior to surgery, biopsies, injections, punctures, blood-taking and bladder catheterisations Videne Antiseptic Solution should be applied undiluted. For the disinfection of skin areas with a sparse distribution of sebaceous glands the exposure time is at least one minute, in skin areas with a dense distribution of sebaceous glands at least 10 minutes. The skin should be kept moist for the entire duration of the exposure time with the undiluted preparation. For the antiseptic treatment of superficial wounds Videne Antiseptic Solution is applied undiluted to the areas to be treated. In antiseptic topical therapy of burn wounds, Videne Antiseptic Solution is generally applied undiluted to the areas to be treated. For antiseptic irrigation, washes and baths Videne Antiseptic Solution can be diluted. The following dilutions are recommended as standard ratios: – Irrigation within the scope of wound treatment (eg, decubitus, varicose ulcer and gangrene) and perioperative infection prophylaxis 1:2 to 1:20 – Antiseptic washes 1:2 to 1:25 – Leggi il documento completo