Страна: Мальта
мова: англійська
Джерело: Medicines Authority
SODIUM IODIDE
GE Healthcare Buchler GmbH & Co. Gieselweg 1, 38110 Braunschweig, Germany
V09FX03
SODIUM IODIDE (131 I) 3.7 MBq
HARD CAPSULE
SODIUM IODIDE (131 I) 3.7 MBq
POM
DIAGNOSTIC RADIOPHARMACEUTICALS
Authorised
2007-04-05
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SODIUM IODIDE (131I) DIAGNOSTIC CAPSULES Sodium Iodide (131I) Diagnostic Capsules 0.333 to 3.7 MBq Capsules, hard Sodium [131I] Iodide (called Sodium Iodide Diagnostic Capsules in this leaflet) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor who will supervise the procedure. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sodium Iodide Diagnostic Capsules are and what they are used for 2. What you need to know before Sodium Iodide Diagnostic Capsules are used 3. How Sodium Iodide Diagnostic Capsules are given 4. Possible side effects 5. How Sodium Iodide Diagnostic Capsules are stored 6. Contents of the pack and other information 1. WHAT SODIUM IODIDE DIAGNOSTIC CAPSULES ARE AND WHAT THEY ARE USED FOR This medicine is used for diagnostic use only. It is used only to help identify illness. Sodium Iodide Diagnostic Capsules are a ‘radiopharmaceutical’ medicine. • They contain an active ingredient called ‘sodium iodide’. • Once taken they can be seen from outside your body by a special camera used in the scan. • The scan can help your doctor see tumours in the thyroid glands, and to see how well a tumour is responding to treatment or if the tumour has spread to other parts of the body. The use of Sodium Iodide Diagnostic Capsules does involve exposure to amounts of radioactivity. Your doctor has considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation. 2. WHAT YOU NEED TO KNOW BEFORE SODIUM IODIDE DIAGNOSTIC CAPSULES ARE USED SODIUM IODIDE DIAGNOSTIC CAPSULES MUST NOT BE USED: • If you are allergic (hypersensitive) to Sodium Iodide Diagnostic Capsules or any of the other ingredients o Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sodium Iodide ( 131 I) Diagnostic Capsules 0.333-3.7 MBq capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Iodide ( 131 I) Diagnostic Capsules are presented as a white capsule. Each capsule contains 3.7 MBq (100 µ Ci) at the first reference date. At subsequent reference dates, at weekly intervals, the nominal activity per capsule is shown in the table below. REFERENCE DATE DAYS AFTER FIRST REFERENCE ACTIVITY - MBQ (ΜCI) 1 0 3.7 (100) 2 7 2.03 (54.9) 3 14 1.11 (30.0) 4 21 0.592 (16.0) 5 28 0.333 (9.0) Iodine-131 is produced by fission of uranium-235 or by neutron bombardment of stable tellurium in a nuclear reactor. Iodine-131 has a half-life of 8.02 days. It decays by emission of gamma radiations of 365 keV (81.7%), 637 keV (7.2%) and 284 keV (6.1%) and beta radiations of maximal energy of 606 keV to stable Xenon131. Excipients with known effect: This medicinal product contains: 85.28mg of sodium per capsule. This needs to be taken into consideration by patients on a sodium controlled diet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. White, opaque gelatin capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. 1. Sodium [ 131 I ] iodide may be given as a “tracer” dose to study radioiodine kinetics. An estimation of the thyroid uptake and effective half life obtained with a tracer dose can be used to calculate the activity required for radioiodine therapy. 2. In the management of thyroid carcinoma, sodium [ 131 I]iodide is used to identify thyroid remnants and metastases (after ablation). 3. Thyroid scanning for benign conditions with sodium [ 131 I]iodide can be performed but only where circumstances do not allow for radiopharmaceuticals with more favourable dosimetry to be used. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The recommended activities for an adult patient (70 kg) are as follows: 1. For thyroid uptak Прочитайте повний документ