Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Potassium iodide
hameln pharma Ltd
Potassium iodide
65mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06020200; GTIN: 5016386008214 5016386008221 5016386008238
N504376.01-UK 504376 SAP No Artwork No 145X300 MM COLOURS APPROVED LEAFLET THYSAT 65 MG TBL UK (HBM/GALVEX - USE) Pharmacode 6071 WHITE PAPER, 50 G/M² Quality Prepared Dimensions Leaflets must comply with PNOM-OD 9 Leaflets developed by HBM Pharma. Folded leaflet size 145X150 MM / PHARMACODES OUTSIDE REPLACES SAP NO. HBM - 56961, GALVEX - 58043 Checked PACKAGE LEAFLET: INFORMATION FOR THE USER ThySat ® 65 mg tablets Potassium iodide HAMELN WHAT IS IN THIS LEAFLET: 1. What ThySat is and what it is used for 2. What you need to know before you take ThySat 3. How to take ThySat 4. Possible side effects 5. How to store ThySat 6. Contents of the pack and other information 1. What ThySat is and what it is used for Potassium iodide is a thyroid blocking agent used to prevent harm caused by radioactive iodine. When taken by someone exposed to radioactive iodine, potassium iodide may prevent damage to the thyroid gland by saturating it with non- radioactive iodine blocking the uptake of radioactive iodine from contaminated air, water, milk and other sources. 2. What you need to know before you take ThySat Do not take ThySat if you: - are, or think you may be, allergic to potassium iodide or any of the other ingredients of this medicine (listed in section 6). If you are allergic to potassium iodide or any of the ingredients listed in section 6 consult your doctor. Warnings and precautions Talk to your doctor or pharmacist before taking ThySat if you: - are being treated for a thyroid problem - suffer from dermatitis herpetiformis (a skin disease) - suffer from hypocomplementaemic vasculitis (a disease causing inflammation of the blood vessels) - have problems with your kidneys - have problems or you are being treated for problems with your adrenal glands - are suffering from dehydration or cramp due to extreme heat. If you are uncertain about any of the above you may want to ask your doctor or pharmacist for advice before taking this medicine. Other medicines and ThySat Tell your doctor or pharmacist if you are taking, ha Perskaitykite visą dokumentą
1. NAME OF THE MEDICINAL PRODUCT THYSAT 65 MG TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 65.00 mg potassium iodide equivalent to 50.00 mg iodine. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet The tablets are white to yellowish slightly marbled round tablets, with a smooth surface without any defects, cross-scored for ease of breaking. The tablet can be divided into equal quarters. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Potassium iodide is indicated as a thyroid-blocking agent to prevent the uptake of radioactive iodine, for example after a nuclear accident or during a nuclear medicine investigation before administering a radioiodinated compound, which is metabolised to iodide or which contains radioiodine impurities. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _NUCLEAR ACCIDENT _ Iodine prophylaxis should be performed in case of a nuclear accident, when radioactive iodine is released, in all people involved including children and pregnant and breastfeeding women located in the endangered area. People with known iodine sensitivity or with a history of active treatment of thyroid disorders should consult their physician. When the nuclear accident is announced the required doses of potassium iodide are as follows: Age group Tablets Iodine equivalent Neonates up to 1 month of age Quarter of a tablet 16 mg potassium iodide equivalent to 12.5 mg iodine Children from 1 month to 3 years of age Half a tablet 32 mg potassium iodide equivalent to 25 mg iodine Children from 3 to 12 years of age 1 tablet 65 mg potassium iodide equivalent to 50 mg iodine Children from 12 years of age, adults and elderly 2 tablets 130 mg potassium iodide equivalent to 100 mg iodine A single daily dose should be administered. This will protect against exposure lasting up to 24 hours (see section 4.4). 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 pregnan Perskaitykite visą dokumentą