Riik: Lõuna-Aafrika Vabariik
keel: inglise
Allikas: South African Health Products Regulatory Authority (SAHPRA)
B Braun Medical (Pty) Ltd
See ingredients
LIQUID
EACH 100 ml LIQUID CONTAINS POVIDONE-IODINE 7,5 g EQUIVALENT TO 0,75 g AVAILABLE IODINE
Registered
1984-09-01
B|BRAUN _ _ Page 1 of 6 PATIENT INFORMATION LEAFLET SCHEDULING STATUS S0 POVIDONE IODINE SCRUB B. BRAUN (POVIDONE IODINE) (Liquid) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING POVIDONE IODINE SCRUB B. BRAUN IS AVAILABLE WITHOUT A DOCTORS PRESCRIPTION FOR YOU. NEVERTHELESS, YOU STILL NEED TO USE POVIDONE IODINE SCRUB B. BRAUN CAREFULLY TO GET THE BEST RESULTS. - Keep this leaflet. You may need to read it again. - Do not share POVIDONE IODINE SCRUB B. BRAUN with any other person - Ask your health care provider or pharmacist if you need more information or advise. WHAT IS IN THIS LEAFLET: 1. What POVIDONE IODINE SCRUB B. BRAUN is and what it is used for 2. What you need to know before you use POVIDONE IODINE SCRUB B. BRAUN 3. How to use POVIDONE IODINE SCRUB B. BRAUN 4. Possible side effects 5. How to store POVIDONE IODINE SCRUB B. BRAUN 6. Contents of the pack and other information 1. WHAT POVIDONE IODINE SCRUB B. BRAUN IS AND WHAT IT IS USED FOR POVIDONE IODINE SCRUB B. BRAUN is a surgical scrub used for the degerming of the hands prior to surgical procedures and pre-operative preparation of the patient’s skin. POVIDONE IODINE SCRUB B. BRAUN may be used to advantage on the patient’s skin following the use of the scrub. B|BRAUN _ _ Page 2 of 6 Effective as an antiseptic wash in infected skin conditions and a general germicidal (germs) cleanser in consulting rooms. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE POVIDONE IODINE SCRUB B. BRAUN DO NOT USE POVIDONE IODINE SCRUB B. BRAUN: • If you are allergic (hypersensitive) to povidone iodine or any of the ingredients POVIDONE IODINE SCRUB B. BRAUN listed in section 6, • On children younger than 2 years of age, • History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis), • Regular use should be avoided in patients on concurrent lithium therapy. WARNINGS AND PRECAUTIONS _Tell your doctor before being administered the product_ • If you are allergic to iodine • If you are doin Lugege kogu dokumenti
B|BRAUN _ _ Page 1 of 6 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS 1. NAME OF MEDICINE POVIDONE IODINE SCRUB B. BRAUN (LIQUID) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mL of POVIDONE IODINE SCRUB B. BRAUN contains 7,5 g of Povidone Iodine equal to 0,75 g of available iodine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Liquid A deep brown coloured foaming liquid having the characteristic odour of iodine. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a surgical scrub for degerming the hands prior to surgical procedure and pre-operative preparation of the patient’s skin. POVIDONE IODINE SCRUB B. BRAUN may be used to advantage on the patient’s skin following the use of the scrub. Effective as an antiseptic wash in infected skin conditions and a general germicidal cleanser in consulting rooms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION S0 B|BRAUN _ _ Page 2 of 6 POVIDONE IODINE SCRUB B. BRAUN should be used undiluted. 4.3 CONTRAINDICATIONS Sensitivity to Povidone Iodine or other Iodine containing products. Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis). Use in children under two years of age. Regular use should be avoided in patients on concurrent lithium therapy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Not to be used by persons allergic to iodine. Use of this preparation may interfere with tests of thyroid function. Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin and may lead to toxic levels of iodine in the blood, particularly in patients with renal insufficiency. If symptoms occur, suggesting changes in thyroid function, these should be monitored. If local irritation and hypersensitivity develop, then discontinue treatment. Hypothyroidism can result from topical application of Povidone Iodine to neonates. Severe metabolic acidosis may Lugege kogu dokumenti