국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Potassium iodate
Alliance Pharmaceuticals Ltd
Potassium iodate
85mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06020200; GTIN: 5024403001131 5024403001124
Artwork Information Product Title: Potassium Iodate 85mg Tablets Date: 13.05.2013 Product Size: Finished size: 148mm x 210mm Label Number: 13-182 Colours Used: Black Fonts Used: Bosis Font size: (min/max) 7.5pt / 24pt Artwork by: PATIENT INFORMATION LEAFLET POTASSIUM IODATE 85MG TABLETS Potassium Iodate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Potassium Iodate 85mg Tablets are and what they are used for 2. What you need to know before you take Potassium Iodate 85mg Tablets 3. How to take Potassium Iodate 85mg Tablets 4. Possible side effects 5. How to store Potassium Iodate 85mg Tablets 6. Contents of the pack and other information 1. WHAT POTASSIUM IODATE 85MG TABLETS ARE AND WHAT THEY ARE USED FOR Potassium Iodate is a thyroid blocking agent, and is used for example after a nuclear accident. Potassium Iodate tablets are used at the time of a nuclear emergency; the tablets stop the thyroid gland (situated in your neck) taking up radioactive iodine, which may be released into the environment following a nuclear accident. Radioactive Iodine is harmful and especially dangerous to babies and children. Ask your doctor, pharmacist or emergency co-ordinator if you need additional information especially concerning the correct use of this product. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE POTASSIUM IODATE 85MG TABLETS DO NOT TAKE POTASSIUM IODATE IF: % you are allergic to potassium iodate, iodine or any of the other ingredients of this medicine (listed in section 6). KEEP IN MIND THAT IF YOU ARE ALLERGIC TO ANY IODINE PRODUCT, THEN YOU 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Iodate 85mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 85mg Potassium Iodate equivalent to 50mg iodine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Off white, round tablet with star shaped double breakline, engraved 2202 on the obverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Potassium iodate is indicated as a thyroid blocking agent to prevent the uptake of radioactive iodine, for example after a nuclear accident. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Administration should take place within 3 hours of a nuclear accident, or up to 10 hours after an accident, however, this is less effective. A single daily dose should be administered. This will protect against exposure lasting up to 24 hours. (see Section 4.4). For neonates living at home a dosage of ¼ tablet is satisfactory. The dosage can be crushed and mixed with milk or water. For neonates in hospital a dosage of 12.5 mg iodine equivalent can be given as a standard solution freshly prepared from KI crystals. It is recommended that maternity wards store KI crystals. For babies the dose may be crushed and mixed with milk or juice before administration. For children the dose may be crushed and mixed with eg. jam, honey or yoghurt. Owing to the sensitivity of the neonate and foetus thyroid to large doses of iodine, repeated administration of stable iodine should be avoided for neonates and pregnant and lactating women. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance, to iodine or to any of the excipients listed in section 6.1 • Renal failure • Hypocomplementaemic vasculitis • Dermatitis herpetiformis. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In cases of exposure to radioiodine from nuclear accidents, dosing of potassium iodate should be based on emergency plans and predetermined operational intervention levels. Risk benefit of administration of stable radioi 전체 문서 읽기