Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
EXAMETAZIME
GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norway
V09AA01
EXAMETAZIME 0.5 mg
POWDER FOR SOLUTION FOR INJECTION
EXAMETAZIME 0.5 mg
POM
DIAGNOSTIC RADIOPHARMACEUTICALS
Withdrawn
2007-08-01
1 CERETEC™ 2 VIAL PACK 5 VIAL PACK N109 – 2 VIAL PACK N109 – 5 VIAL PACK KIT FOR THE PREPARATION OF TECHNETIUM [ 99M TC] EXAMETAZIME INJECTION PRESENTATION Each vial of Ceretec™ contains exametazime (HM-PAO or [RR.SS]-4,8-diaza-3,6,6,9- tetramethylundecane-2,10-dione bisoxime) (0.5mg), stannous chloride dihydrate (7.6μg) and sodium chloride (4.5mg) as a freeze-dried mixture sealed under nitrogen. Powder for injection following reconstitution with 5ml of sterile Sodium Pertechnetate [ 99m Tc] Injection Ph. Eur. at a radioactive concentration of 74- 222MBq/ml (2-6 mCi/ml). The pH of the injection is 9.0 - 9.8. This yields Technetium [ 99m Tc] Exametazime injection, a diagnostic radio-pharmaceutical imaging agent for single dose use. Packs of 2 and 5 vials are available. Labels for the reconstituted product and sanitizing swabs (containing 70% isopropyl alcohol BP) are provided. HOLDER OF MARKETING AUTHORISATION GE Healthcare AS Nycoveien 1, 0485 Oslo, 0301 Oslo, Norway MANUFACTURER GE Healthcare AS P.O.Box 4220 Nydalen NO-0401 Oslo Norway INDICATIONS (i) Technetium [ 99m Tc] Exametazime 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. (ii) Technetium [ 99m Tc] Exametazime 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. CONTRAINDICATIONS There are no specific contra-indications PRECAUTIONS FOR USE This product is not to be administere Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ceretec™ Kit for the preparation of Technetium [ 99m Tc] Exametazime Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Exametazime 0.5 mg. 3 PHARMACEUTICAL FORM Powder for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (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_ . Dose for adults and the elderly: (1) for brain scintigraphy, 350-500MBq (2) for _in vivo _ localisation of technetium-99m-labelled leucocytes, 200MBq Normally a once-only diagnostic procedure. Page 1 of 11 Page 2 of 11 Technetium [ 99m Tc]-Exametazime and Technetium-99m-labelled leucocytes are not recommended for administration to children. 4.3 CONTRAINDICATIONS There are no specific contra-indications. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Radiopharmaceutical agents should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides. They may be received, used and adminis Baca dokumen lengkap