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3700 Mbq/Ml Oral Solution for Therapeutic Use Sodium Iodide (131I)

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3700 Mbq/Ml Oral Solution for Therapeutic Use Sodium Iodide (131I) PACKAGE LEAFLET: INFORMATION FOR THE USER MONIYOT-131 14.8 – 3700 MBq/ml oral solution for therapeutic use Sodium Iodide (131I) Read all of this leaflet carefully before you start using 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 Nuclear Medicine doctor who will supervise the procedure. • If you get any side effects, talk to your Nuclear Medicine doctor who has supervised the procedure. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What MONIYOT-131 is and what it is used for 2. What you need to know before you take MONIYOT-131 is administered 3. How to take MONIYOT-131 4. Possible side effects 5. How to store MONIYOT-131 6. Contents of the pack and other information 1. What MONIYOT-131 is and what it is used for This medicine is a radiopharmaceutical product for therapeutic use only. MONIYOT-131 use can be used for: • Treatment of thyroid diseases like increased activity of the thyroid gland (Graves’ disease) and enlargement of the thyroid gland (toxic multinodular goitre or autonomous nodules) • Treatment of thyroid cancer including metastasis (papillary and follicular thyroid carcinoma) The use of MONIYOT-131 does involve exposure to radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical overcomes the risk due to radiation. 2. What you need to know before you take MONIYOT-131 Do not use MONIYOT-131 • if you are allergic to Sodium Iodide (131I) or any of the other ingredients of this medicine (listed in section 6). • if you are pregnant or breast-feeding your child • if you have difficulties in swallowing (dysphagia, oesophageal stricture, oesophagal stenosis, oesophagus diverticulum) • if you suffer from stomach disorders like inflammation (gastritis) and peptic ulcer • if you suffer from reduced abdominal or bowel movements • if your gullet is obstructed if the product is intended solely for making the thyroid gland visible. Usually other products containing sodium iodide (I-123) or Technetium (Tc-99m) are used for this. Exceptions to this advice are if these products are not available in the clinic where you are treated or if you are being treated for cancer. Warnings and precautions Take special care with MONIYOT-131 • If you receive therapy for your thyroid, you should be re-examined regularly to check thyroid hormone levels and to identify possible late complications. • After treatment you are encouraged to drink plenty and to void frequently to prevent accumulation of sodium iodide (131I) in the bladder. If you have bladder voiding problems you will be catheterized after high dose administration • Directly after swallowing the solution you have radioactive material in you. You will be shielded from your surroundings for some time. Also stools, urine or vomit that leaves your body are considered radioactive and should be disposed with care so they will not come into contact with others. • If you have a stomach disease. Concomittant use of medicines to treat ulcer disease and gastritis (H2 antagonists or proton pump inhibitors) is advised. • If you have a significantly reduced kidney function which requires dose adjustment. To avoid inflammation of the salivary glands, you are advised to take sweets or drinks containing citric acid which will stimulate saliva flow. Before treatment you will be advised to take food that contains little iodine to increase the uptake in the thyroid gland. • If you use thyroid hormones. Thyroid replacement therapy should be stopped prior to administration to ensure adequate uptake. A period of 14 days is recommended for triiodothyronine and 4-5 weeks for thyroxine. They should be restarted two weeks after treatment. Similarly carbimazole and propythiouracil should be stopped 1 week prior to treatment of increased activity of the thyroid gland (hyperthyroidism) and restarted several days later. • If protruding eyes is part of the symptoms of the disease you are suffering from (Graves’ disease-induced ophthalmopathy). In this case you should receive simultaneous medication to reduce inflammation (corticosteroids). • After treatment women should use contraception for a time period of 6-12 months. Men should use contraception for a time period of 6 months after treatment. • Your doctor will inform you which special precautions that have to be taken. • The receipt, storage, use, transfer and disposal of radiopharmaceuticals are subject to the regulations and/or appropriate licences of the local competent official organization. As a result MONIYOT-131 will always be administered in a hospital or other designated clinical setting. Before MONIYOT-131 administration you should: • Drink plenty of water and to be well hydrated before the start of the administration in order to urinate as often as possible during the first hours after the study • Fast (no food) for at least 4 hours Talk to your Nuclear Medicine doctor before using MONIYOT-131: • If you are pregnant or believe you may be pregnant • If you are breastfeeding • If you are under 18 years old Other medicines and MONIYOT-131 Please tell your Nuclear Medicine doctor who will supervise the procedure if you are taking or have recently taken any other medicines, including medicines obtained without prescription. Please tell your Nuclear Medicine doctor if you are taking or have been administered any of the following medicines/substances, since they may interfere with your physician’s interpretation of the images. Your doctor may recommend that you stop the following medicines before treatment: • Medicines used to reduce thyroid gland function such as: - carbimazole, methimazole, propyluracil - perchlorate. These medicinal products are to be withheld 1 week before treatment with sodium iodide (131I) until several days after. • The medicinal products listed below, used for various clinical situations, are to be withheld 1 week before treatment: - salicylates: medicines to reduce pain, fevers or inflammation such as acetylsalicylic acid. - cortisone: medicines to reduce inflammation or prevent organ transplantat rejection. - sodium nitroprusside: a medicine to reduce high blood pressure, and also during an operation. - sodium sulfobromophthalein: a medicine to test liver function - Certain drugs: • to reduce blood coagulation • to treat parasitic infestation • antihistamines : used to treat allergies • penicillins and sulphonamides: antibiotics, • tolbutamide: a medicine to reduce blood sugar • thiopentone: used while under anaesthetic to reduce brain pressure, and also to treat extreme epileptic seizures • phenylbutazone (a medicine to reduce pain and imflammation) is to be withheld 1-2 week before treatment. • iodine containing medicines to help free the airways of sputum, are to be withheld 2 weeks before treatment. • vitamins containing iodine salts are to be withheld 2 weeks before treatment. • medicines containing thyroid hormones such as, thyroxine, liothyronine, triiodothyronine, thyroid extract are to be withheld 2-5 weeks before treatment. • benzodiazepines (medicines which calm and initiate sleep and relax muscles) are to be withheld 4 weeks before treatment. • lithium (a medicine to treat depression) is to be withheld 4 weeks before treatment. • iodide containing medicines (which are used only on a restricted area of the body) are to be withheld 1 – 9 months before treatment. • amiodarone (a medicine to treat heart rhythm disorders) is to be withheld several months before treatment. • iodine containing contrast media are to be withheld up to 1 year before treatment. MONIYOT-131 with food and drink MONIYOT-131 should be taken fasting (on an empty stomach) and with plenty of liquid. Pregnancy, breast-feeding and fertility You must inform the Nuclear medicine doctor before the administration of MONIYOT-131 if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding. When in doubt, it is important to consult your Nuclear medicine doctor who will supervise the procedure. • If you are pregnant Do not take MONIYOT-131 if you are pregnant. Any possibility of pregnancy must be ruled out before using this medicine. Additionally, you are advised not to become pregnant within 6- 12 months after taking MONIYOT-131. The Nuclear medicine doctor will only administer this product during pregnancy if a benefit is expected which would outweigh the risks. • If you are breast-feeding Tell your doctor if you are breast-feeding as he may delay treatment until breast-feeding is finished. He may also ask you to stop breast-feeding after taking MONIYOT-131. • Fertility Women are advised to use contraception for a time period of 6 -12 months. As a precaution, men should not father a child for a time period of 6 months after radioiodine treatment. If you are pregnant, think you may be pregnant or are planning to have a baby, or if you are breast-feeding ask your Nuclear Medicine doctor for advice before taking this medicine. Please ask your Nuclear Medicine doctor before taking any medicine. Driving and using machines It is considered unlikely that MONIYOT-131 will affect your ability to drive or to operate machinery. MONIYOT-131 contains sodium • This medicinal product contains 5.7 mg sodium per ml. This must be taken into consideration by patients on a controlled sodium diet. 3. How to take MONIYOT-131 There are strict laws on the use, handling and disposal of radiopharmaceutical products. MONIYOT-131 will only be used in special, controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions. The Nuclear Medicine doctor supervising the procedure will decide on the quantity of MONIYOT-131 to be used in your case. It will be the minimal quantity necessary to get the desired effect.
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