Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Iodinated povidone ph.eur.
Ecolab Deutschland GmbH
D08AG; D08AG02
Iodinated povidone ph.eur.
10 percent weight/weight
Cutaneous solution
Iodine products; povidone-iodine
Marketed
2000-06-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VIDENE 10% W/W ALCOHOLIC TINCTURE 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 you 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 VideneAlcoholic Tincture in this label-leaflet, contains iodinated povidone as the active substance. It is an antiseptic skin cleanser for use as a quick-drying antiseptic for pre-operative skin disinfection, particularly in orthopaedic surgery. Solutions of iodinated povidone gradually release iodine to kill or stop the growth of micro-organisms (bacteria, fungi, viruses, protozoa, cysts and spores). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DO NOT USE: - On newborn children. - During pregnancy and breastfeeding. - If you are sensitive to iodine or any of the other ingredients of this medicine (listed in section 6). - For regular or prolonged periods if you have thyroid problems or if you are taking lithium (an anti-depressant). - On broken skin as the alcohol could cause stinging. - For external use only. Do not swallow WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before using Videne Alcoholic Tincture if: - You are using on large wounds or severe burns as it could product adverse effects such as changes in blood chemistry and problems with the kidneys. - You are prone to, or have ever been treated in the past for hyperthyroidism. OTHER MEDICINES AND VIDENE ALCOHOLIC T Przeczytaj cały dokument
Health Products Regulatory Authority 21 May 2019 CRN0091ZM Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Videne 10% w/w Alcoholic Tincture 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Iodinated povidone 10% 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 10% w/w Alcoholic Tincture is a broad-spectrum antiseptic for topical application. It is indicated for quick drying pre-operative skin disinfection, particularly in orthopaedic surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Videne 10% w/w Alcoholic Tincture is applied undiluted to the area to be incised and painted on thoroughly using a gauze swab. The solution may be allowed to dry to form a protective film or may be removed using a sterile gauze swab. _Neonates:_ Do not use on neonates, refer to Section 4.3. _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. 4.3 CONTRAINDICATIONS Videne 10% w/w Alcoholic Tincture 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 the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Care should be taken with known iodine-sensitive subjects, although such people do not normally react to iodinated povidone. Health Products Regulatory Authority 21 May 2019 CRN0091ZM Page 2 of 4 Videne 10% w/w Alcoholic Tincture must not be used on broken skin because of the intense stinging caused by the alcohol present. The application of povidone-iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia, and impairment of renal function. 4.5 INTERACTION W Przeczytaj cały dokument