Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Oxidronate disodium
Curium Netherlands B.V.
V09BA; V09BA01
Oxidronate disodium
3 milligram(s)
Kit for radiopharmaceutical preparation
Product subject to prescription which may not be renewed (A)
Technetium (99mTc) compounds; technetium (99mTc) oxidronic acid
Marketed
1993-11-19
PA 0690-004-001 Approved PIL DRN 4366 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TECHNESCAN HDP Kit for radiopharmaceutical preparation. sodium oxidronate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU WILL BE ADMINISTERED 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. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Technescan HDP is and what it is used for 2. What you need to know before Technescan HDP is used 3. How Technescan HDP is used 4. Possible side effects 5. How Technescan HDP is stored 6. Contents of the pack and other information 1. WHAT TECHNESCAN HDP IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical product for diagnostic use only. Technescan HDP is used through a scan to examine the: BONES The use of Technescan HDP does involve exposure to small amounts of radioactivity. Your doctor and the Nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweights the risk due to radiation. This medicine is a powder. When mixed by qualified people, with a solution of the radioactive substance, sodium pertechnetate ( 99m Tc) it forms Technetium ( 99m Tc) oxidronate. When administered into the body it collects in certain organs such as the bones. The radioactive substance can be photographed from outside the body, using special cameras which take a scan. This scan shows the distribution of radioactivity within the body. This gives the doctor valuable information about the structure and function of a specific part of the body. 2. WHAT YOU NEED TO KNOW BEFORE TECHNESCAN HDP IS USED TECHNESCAN HDP MUST NOT BE USED if you are allergic (hypersensitive) to sodium oxidronate or any of the other ingredients of this me Lugege kogu dokumenti
Health Products Regulatory Authority 13 December 2021 CRN00CMFV Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TechneScan HDP 3 mg, kit for radiopharmaceutical preparation 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Oxidronate 3.0 mg The radionuclide is not part of the kit. Excipients: Sodium 12 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. Powder for solution for injection. Grey-white lyophilized powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After radiolabelling with sodium pertechnetate ( 99m Tc) solution, the agent may be used for bone scintigraphy, where it delineates areas of altered osteogenesis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The average activity administered by single intravenous injection is 500 MBq (300 - 740 MBq) in a 70 kg adult. Other activities may be justifiable. It should be noted that in each country physicians should follow the Diagnostic Reference Levels and the rules set out by local law. _Elderly population_ There is no special dosage regimen for the elderly patient. _Paediatric population_ The use in paediatric children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. The activities to be administered to children and to adolescents were calculated according to the EANM dosage card (2014) by using the following Formula: _A_[_MBq_]Administered = _Baseline Activity _x _Multiple_ (with a baseline activity of 35.0) The resulting activities to be administered may be found in the following table: Weight (kg) Activity (MBq) Weight (kg) Activity (MBq) Weight (kg) Activity (MBq) 3 40 22 185 42 320 4 40 24 200 44 335 6 60 26 215 46 350 8 75 28 225 48 360 10 95 30 240 50 375 12 110 32 255 52 - 54 395 14 125 34 270 56 - 58 420 16 140 36 280 60 - 62 445 18 155 38 295 64 - 66 470 Health Products Regulatory Authority 13 Decemb Lugege kogu dokumenti