Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
IODINATED POVIDONE PH.EUR.
Ecolab Limited
D08AG02
IODINATED POVIDONE PH.EUR.
7.5 %w/w
Cutaneous Solution
Product not subject to medical prescription
povidone-iodine
Marketed
2000-06-23
7.5 W/W SURGICAL SCRUB (IODINATED POVIDONE) PRODUCT TITLE: PRODUCT SIZE: LABEL NO: FILE NO. / DATE: Videne Surgical Scrub Irish 500ml 3030450F 09/12/13 ADAMS HEALTHCARE APPROVAL APPROVED BY PRODUCTION MARKETING TECHNICAL DGTG SIGNATURE DATE REASON FOR CHANGE: User Testing PACK DIMENSIONS: DESIGN INFORMATION COLOURS: FONTS: POINT SIZES: 115 x 48mm Helvetica Neue 55 Roman Helvetica Neue 75 Bold Helvetica Neue 56 Italic Helvetica Compressed Pantone Process Cyan Black Die Cut Minimum 5pt Videne ® 500ML Videne Surgical Scrub is an antiseptic skin cleanser for use as a pre-operative skin disinfection for the surgical team and for disinfecting the site of incision prior to surgery. Contains 7.5% w/w povidone-iodine. Also contains alkyl phenol ether sulphate (ammonium salt), macrogol 400, cocoamide diethanolamide, glycerol, povidone, citric acid, anhydrous disodium hydrogen phosphate, purified water. READ LEAFLET BEFORE USE. CUTANEOUS SOLUTION. FOR EXTERNAL USE ONLY. Keep out of the reach and sight of children. Do not store above 25°C. MA Holder: ECOLAB LTD. Lotherton Way, Garforth Leeds LS25 2JY England Tel: +44 (0)113 232 0066 P PA1110/10/1 3030450F/16NOV13/IE PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VIDENE SURGICAL SCRUB 7.5% W/W Iodinated povidone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or nurse has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What it is and what it is used for 2. What you need to know before use 3. How to use 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IT IS AND WHAT IT IS USED FOR This product, referred to as Videne Surgical Scrub in thi Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Videne 7.5% w/w Surgical Scrub 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Iodinated Povidone 7.5% w/w 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 Videne 7.5% w/w Surgical Scrub 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION PRE-OPERATIVE SURGICAL SCRUB - after first wetting the hands and arms with water, approximately 3.5ml of Videne 7.5% w/w Surgical Scrub 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 Videne 7.5% w/w Surgical Scrub two or three times a day prior to the operation. Immediately before surgery the skin should be moistened with water, Videne 7.5% w/w Surgical Scrub 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 Videne 7.5% w/w Surgical Scrub. _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. 4.3 CONTRAINDICATIONS Videne 7.5% w/w Surgical Scrub must never be administered orally, and is contra-indicated in neonates, and during pregnancy and lactation. Regular or prolonged use should be avoided in patients with thyroid disorders or those receiving lithium therapy. Hypersensitivity to any of t Prečítajte si celý dokument