Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Iodinated povidone
Ecolab Deutschland GmbH
D08AG; D08AG02
Iodinated povidone
7.5 percent weight/weight
Cutaneous solution
Iodine products; povidone-iodine
Marketed
2000-06-23
Page 1 of 3 Videne 7.5% w/w Surgical Scrub (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 this label-leaflet, contains iodinated povidone as the active substance. It 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. Solutions of iodinated povidone gradually release iodine to kill or stop the growth of 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). For external use only. Do not swallow. WARNINGS AND PRECAUTIONS: Talk to your doctor or nurse before using Videne Surgical Scrub if: You are using on large wounds or severe burns as it could produce 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 SURGICAL SCRUB Talk to your doctor or nurse before using Videne Surgical Scrub if you are t Đọc toàn bộ tài liệu
Health Products Regulatory Authority 14 June 2023 CRN00DMC8 Page 1 of 4 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 di Đọc toàn bộ tài liệu