Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
EXAMETAZIME
GE Healthcare Limited
V09AA01
EXAMETAZIME
500 Microgram
Kit for radiopharmaceutical preparation
Product subject to prescription which may not be renewed (A)
technetium (99mTc) exametazime
Marketed
1988-04-19
In more serious cases reactions may include: • passing out (unconsciousness), feeling dizzy or lightheaded. If any of the side effects above happen after you leave the hospital or clinic, you should go or be taken straight to the casualty department of your nearest hospital. Other side effects include (frequency not known) • itchy lumpy rash • headache • feeling dizzy • fl ushing • feeling sick (nausea) • being sick (vomiting) • general feeling of being unwell, weak or tired • unusual feelings of numbness, tingling, prickling burning or creeping on skin. This radiopharmaceutical will deliver low amounts of ionising radiation with the least risk of cancer and hereditary abnormalities. REPORTING OF SIDE EFFECTS If you notice any side effects, or if you notice any side effects not listed in this leafl et, please tell your Nuclear medicine doctor who supervises the procedure. You can also report side effects directly to: HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie By reporting side effects, you can help provide more information on the safety of this medicine. 5. HOW CERETEC IS STORED You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of After injection, you will be offered a drink and asked to urinate immediately preceding the test. Ceretec will always be used in a hospital or clinic. Ceretec will be given to you by a specially trained and qualifi ed person. They will provide you with the necessary information on the procedure. DURATION OF THE PROCEDURE Your nuclear medicine doctor will inform you about the usual duration of the procedure. AFTER ADMINISTRATION OF CERETEC YOU SHOULD: • urinate frequently in order to eliminate the product from your body The nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Contact your nuclear medicine doctor if Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceretec 500 micrograms kit for radiopharmaceutical preparation. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains exametazime 500 micrograms. Ceretec is reconstituted with Sodium Pertechnetate ( 99m Tc) Injection (not included in this kit) to prepare Technetium ( 99m Tc) Exametazime Injection. Excipients with known effect The product before reconstitution contains sodium: 1.77 mg/vial. This needs to be taken into consideration for patients on a controlled sodium diet. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. A white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After reconstitution with Sodium Pertechnetate ( 99m Tc) Injection, the product is indicated in adults for: 1. Technetium ( 99m Tc) Exametazime Injection is indicated for brain scintigraphy. The product is to be used for the diagnosis of abnormalities of regional cerebral blood flow, such as those occurring following stroke and other cerebrovascular disease, epilepsy, Alzheimer’s disease and other forms of dementia, transient ischaemic attack, migraine and tumours of the brain. 2. Technetium ( 99m Tc) Exametazime Injection is also indicated for_ in vitro_ technetium-99m leucocyte labelling, the labelled leucocytes subsequently being re-injected and scintigraphy carried out to image the sites of localisation. This procedure may be used in the detection of sites of focal infection (e.g. abdominal abscess), in the investigation of pyrexia of unknown origin and in the evaluation of inflammatory conditions not associated with infection such as inflammatory bowel disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The route of administration is direct intravenous injection for brain scintigraphy studies and intravenous injection of labelled leucocytes post labelling_ in vitro_. POSOLOGY Adults and the elderly population H E A L T H P R O D U C T S R E Baca dokumen lengkapnya