qanastek/EMEA-V3 huggingface dataset:
What is DaTSCAN used for?
Għalxiex jintuża DaTSCAN?
DaTSCAN is for diagnostic use only.
DaTSCAN jintuża biss għal skopijiet dijanjostiċi.
DaTSCAN is used to detect the loss of nerve cells in an area of the brain called the striatum.
DaTSCAN jintuża biex isir magħruf jekk ikunx hemm telfien ta ’ ċelloli tan- nervituri f’ parti tal- moħħ magħrufa bħala striatum.
It specifically helps to detect the loss of nerve cells that release dopamine, a chemical messenger.
Jgħin speċifikament biex ikun magħruf jekk hemmx telfien ta ’ ċelloli tan- nervituri li jirrilaxxaw id- dopamina, messaġġier kimiku.
The medicine is used to help in the diagnosis of: • movement disorders such as those seen in Parkinson’ s disease and other related diseases, where a loss of striatal nerve cells in the brain leads to tremor (shaking), gait disturbance and stiffness of muscles.
Il- mediċina tintuża biex tgħin fid- dijanjożi ta ’: • Problemi tal- moviment bħal dawk li jseħħu fil- marda ta ’ Parkinson u f’ mard ieħor relatat, fejn ikun hemm rogħda, tfixkil fil- mixi u għebusija tal- muskoli minħabba telfien fiċ- ċelloli tan - nervituri fl- istriatum tal- moħħ.
But these disorders can also occur in ‘ essential tremor’ (tremor whose cause is not known).
Iżda dawn il- problemi jistgħu jseħħu wkoll fir - ‘ rogħda essenzjali ’ (rogħda li l- kawża tagħha mhix magħrufa).
DaTSCAN is used to help distinguish between Parkinson’ s disease and essential tremor. • dementia (loss of intellectual function):
DaTSCAN jgħin biex jiddistingwi bejn il- marda ta ’ Parkinson u r- rogħda essenzjali. • Id- dimenzja (telfien ta ’ funzjonijiet intellettwali):
The medicine can only be obtained with a prescription.
DaTSCAN jintuża biex jgħin fid- distinzjoni bejn tip ta ’ dimenzja magħrufa bħala ‘ dementia with Lewy bodies ’ mill- marda ta ’ Alzheimer Il- mediċina tista ’ tinkiseb biss b’ riċetta medika.
How is DaTSCAN used?
Kif jintuża DaRSCAN?
DaTSCAN should only be used in patients who have been referred by a doctor who has experience in the management of movement disorders or dementia.
DaTSCAN għandu jintuża biss minn pazjenti li jkun irreferiehom tabib li jkollu esperjenza fil- ġestjoni ta ’ problemi tal- moviment jew tad- dimenzja.
DaTSCAN will only be handled and given by people who have experience in the safe handling of radioactive material.
DaTSCAN jiġi manipulat u jingħata biss minn persuni b’ esperjenza fil- manipulazzjoni sigura ta ’ materjal radjuattiv.
When receiving DaTSCAN, patients must also take another medicine (such as iodine tablets) to prevent their thyroid gland from taking up the iodine contained in DaTSCAN.
Meta jingħataw DaTSCAN, il- pazjenti għandhom jieħdu wkoll mediċina oħra (bħal pilloli tal- jodju) biex ma jħallux lill- glandola tat- tirojde tieħu l- jodju ta ’ ġo DaTSCAN.
This is taken 1 to 4 hours before and 12 to 24 hours after DaTSCAN.
Din tingħata bejn siegħa u 4 sigħat qabel u bejn 12 u 24 siegħa wara DaTACAN.
DaTSCAN is given by slow intravenous injection (not less than 15 to 20 seconds) into an arm vein, and a scan is taken 3 to 6 hours after the injection.
DaTSCAN jingħata permezz ta ’ injezzjoni fil - vina bil- mod (mhux inqas minn bejn 15 u 20 sekonda) f’ vina tad- driegħ u jittieħed skan bejn tliet u sitt sigħat wara l- injezzjoni.
How does DaTSCAN work?
Kif jaħdem DaTSCAN?
The active substance in DaTSCAN, ioflupane (123I), is a radiopharmaceutical.
Is- sustanza attiva f’ DaTSCAN, ioflupana (123I), hija prodott radjufarmaċewtiku.
It contains a substance, ioflupane, that has been labelled with 123I (iodine-123), a radioactive form of the chemical element iodine.
Tikkonsisti minn sustanza, ioflupane, li tkun ġiet ittikkettata b’ 123I (iodine- 123), forma radjuattiva ta ’ l- element kimiku tal- jodju.
Ioflupane binds specifically to structures on the surface of nerve cell endings in the striatum area of the brain that are responsible for the transport of dopamine.
Ioflupane jingħaqad speċifikament ma ’ strutturi fuq il- wiċċ ta ’ truf tan- nervituri fl- istratium tal- moħħ li jkunu responsabbli mit- trasport tad- dopamina.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged (SPECT) that detects the radioactive iodine-123..
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Ir- riproduzzjoni u/ jew id- distribuzzjoni ta ’ dan id- dokument huma awtorizzati għal għanijiet mhux kummerċjali biss dejjem jekk EMEA tkun rikonoxxuta Meta DaTSCAN jiġi injettat fil- pazjent, ioflupane (123I) jiġi distribwit fil- ġisem permezz taċ - ċirkulazzjoni u jakkumula fl- istriatum, fejn jingħaqad ma ’ strutturi tat- trasport.
If there is a loss of nerve cells containing dopamine (as occurs typically in patients with Parkinson’ s disease) the binding of DaTSCAN is greatly reduced and this can be seen on the scan.
Jekk ikunu nqerdu ċelloli tan- nervituri li jkun fihom id- dopamina (kif sikwit jiġri f’ pazjenti bil- marda ta ’ Parkinson) l - għaqda ta ’ DaTSCAN titnaqqas ħafna u dan jidher fl- iskan.
How has DaTSCAN been studied?
Kif ġie studjat DaTSCAN?
In Parkinson’ s disease, DaTSCAN has been studied in 254 patients in two studies.
Fil- marda ta ’ Parkinson, DaTSCAN ġie studjat f’ 254 pazjent f’ żewġ studji.
In both studies, images obtained in healthy volunteers (45 in total) were compared to those in patients with Parkinson’ s disease (180 patients) or essential tremor (29 patients).
Fiż- żewġ studji tqabblu immaġni miksuba minn voluntiera f’ saħħithom (45 b’ kollox) li tqabblu ma ’ dawk f’ pazjenti bil- marda ta ’ Parkinson (180 pazjent) jew rogħda essenzjali (29 pazjent).
In dementia, DaTSCAN has been studied in 288 patients who had been diagnosed with either dementia with Lewy bodies or Alzheimer’ s disease, as well as some other forms of dementia.
Fid- dimenzja, DaTSCAN ġie studjat f’ 288 pazjent li jkunu ingħataw dijanjożi ta ’ demenzja bil- Lewy bodies jew bil- marda ta ’ Alzheimer, kif ukoll xi forom oħra tad- dimenzja.
In all studies, the measure of effectiveness was the accuracy of the diagnosis based on the images from the scan compared to the diagnosis made by a specialist doctor.
F’ kull studju, il- kejl ta ’ l - effikaċja kienet l- akkuratezza tad- dijanjożi bbażata mill- immaġni ta ’ l- iskan komparata mad- dijanjożi magħmula minn speċjalista.
What benefit has DaTSCAN shown during the studies?
X’ benefiċċju wera DaTSCAN matul l- istudji?
In the main study of patients with Parkinson’ s disease and essential tremor, the sensitivity of DaTSCAN was 96.5%.
Fl- istudju prinċipali ta ’ pazjenti bil- marda tal- Parkinson u rogħda essenzjali, is- sensittività ta ’ DaTSCAN kienet 96. 5%.
This means that the disease identified by the doctor reading the images obtained using DaTSCAN matched the existing diagnostic of the patients in 96.5% of cases.
Dan ifisser li l- marda identifikata mit- tabib li kien qed jaqra l- immaġni miksubin permezz ta ’ DaTSCAN qablu mad- dijanjostika eżistenti tal- pazjenti f’ 96. 5% tal- każijiet.
The values for the sensitivity of DaTSCAN to distinguish probable dementia caused by Lewy bodies from other types of dementia ranged from 75.0 to 80.2%.
Il - valuri għas- sensittività ta ’ DaTSCAN sabiex jagħmlu distinzjoni bejn il- probabbiltà ta ’ dimenzja ikkawżata minn Lewy bodies minn tipi oħra ta ’ dimenzja varjaw minn 75. 0 għal 80. 2%.
What is the risk associated with DaTSCAN?
X’ inhu r- riskju marbut ma ’ DaTSCAN?
Common side effects observed with the use of DaTSCAN are increased appetite, headache, formication (a sensation of something crawling on or under the skin), and vertigo (a spinning sensation).
Fost l- effetti sekondarji li jseħħu bl- użu ta ’ DaTSCAN insibu żieda fl- aptit, uġigħ ta ’ ras, formikazzjoni (sens ta ’ xi ħaġa titkaxkar fuq jew taħt il- ġilda), u vertigo (sensazzjoni ta ’ tidwir).
The risk caused by radioactivity is thought to be very low.
Hu maħsub li r- riskju kkawżat mir- radjuattività hu baxx ħafna.
For the full list of all side effects reported with DaTSCAN, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji ta ’ DaTSCAN, ara l- Fuljett ta ’ Tagħrif.
DaTSCAN should not be used in people who may be hypersensitive (allergic) to ioflupane or any of the other ingredients, or in women who are pregnant.
DaTSCAN m’ għandux jintuża minn persuni li jista ’ jkollhom sensittività eċċessiva (allerġija) għal ioflupane jew għal xi sostanza oħra tiegħu, jew minn nisa tqal.
The Committee for Medicinal products for Human Use (CHMP) decided that DaTSCAN’ s benefits are greater than its risks as a diagnostic agent to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson’ s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy, and to help differentiate probable dementia with Lewy bodies from Alzheimer ’ s dementia.
Għaliex ġie approvat DaTSCAN Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ DaTSCAN huma ikbar mir- riskji tiegħu bħala aġent dijanjostiku biex jgħin fid- distinzjoni bejn Rogħda Essenzjali mis- Sindromi tal- Parkinson relatati ma ’ Marda ta ’ Parkinson idjopatika, Multiple System Atrophy u Progressive Supranuclear Palsy, u biex jgħin fid- distinzjoni bejn il- probabbiltà ta ’ dimenzja b’ Lewy bodies mill- marda ta ’ l- Alżeimer.
The committee recommended that DaTSCAN be given marketing authorisation.
Il- Kumitat irrakkomanda li DaTSCAN jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Other information about DaTSCAN:
Informazzjoni oħra dwar DaTSCAN:
The European Commission granted a marketing authorisation valid throughout the European Union for DaTSCAN to GE Healthcare Limited on 27 July 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal DaTSCAN lil GE Healthcare Limited fis- 27 ta ’ Lulju 2000.
The marketing authorisation was renewed on 27 July 2005.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fis- 27 ta ’ Lulju 2005.
The full EPAR for DaTSCAN is available here.
L- EPAR sħiħ dwar DaTSCAN jista ’ jinstab hawnhekk.
This summary was last updated in 02-2007.
Dan is- sommarju kien aġġornat l- aħħar fi 02- 2007.
Route of administration
Mnejn jinġħata
Content
Il- Kontenut
Package size
Kemm jesa ’ l- pakkett
Solution for injection
Soluzzjoni ghall - injezzjoni
Intravenous use
Użu ghal gol- vini
Vial, glass
Kunjett, ħġieġ
2.5 ml
2. 5ml
1 x 10 ml
1x10ml
5.0 ml
5. 0ml
DaTSCAN 74 MBq/ ml solution for injection
DaTSCAN 74 MBq/ ml soluzzjoni għall- injezzjoni
Ioflupane (123I) 74 MBq/ ml at reference time (0.07-0.13 μ g/ ml of ioflupane).
Ioflupane (123I) 74 MBq/ ml mill- ħin ta 'riferiment (0. 07 - 0. 13 μg/ ml ta' ioflupane).
2.5 ml vials contain 185 MBq and 5 ml vials contain 370 MBq ioflupane (123I) (specific activity range 2.5-4.5 x 1014 Bq/ mmol) at reference time.
Fjali tat - 2. 5 ml fihom 185 MBq u fjali tal- 5 ml fihom 370 MBq ioflupane (123I) (attività speċifika fil - limiti ta ’ 2. 5 – 4. 5 x 1014 Bq/ mmol) mill- ħin ta 'referenza.
This medicinal product contains 5% volume ethanol.
Dan il- prodott mediċinali fih 5% tal- volum ta ’ ethanol.
For a full list of excipients see section 6.1
Għal- lista kompleta ta ’ sustanzi mhux attivi ara sezzjoni 6. 1.
Solution for injection.
Soluzzjoni għall- injezzjoni
Clear colourless solution
Soluzzjoni ċara ta ’ bla kulur
This medicinal product is for diagnostic use only.
Dan il- prodott mediċinali huwa għall- użu dijanjostiku biss.
DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:
DaTSCAN huwa indikat għall- osservazzjoni tan- nuqqas tat- terminali tan- newroni dopaminerġiċi li jiffunzjonaw fl- istrajatum:
• In patients with clinically uncertain Parkinsonian Syndromes, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson’ s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.
• F’ pazjenti li jbatu bis- Sindromi ta 'Parkinson li għadhom mhux ċerti klinikament, biex jgħin jagħraf bejn Tregħid Essenzjali u Sindromi ta' Parkinson relatati mal - Marda ta 'Parkinson idjopatika, Atrofija Multipla tas- Sistema u Paraliżi Progressiva Supranukleari.
DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson’ s disease dementia.
DaTSCAN ma jistax jagħraf bejn il- Marda ta 'Parkinson, Atrofija Multipla tas - Sistema u Paraliżi Progressiva Supranukleari. • Sabiex ikun hemm divrenzjar probabbli bejn dimenzja mal- korpi Lewy minħabba l - marda ta ’ Alzheimer DaTSCAN mhux kapaċi jiddivrenzja bejn dimenzja mal- korpi Lewy u dimenzja minħabba l- mard tal- Parkinson.
DaTSCAN should only be used in patients referred by physicians experienced in the management of movement disorders and/ or dementia.
DaTSCAN għandu jintuża biss f 'pazjenti li huma riferuti minn tobba b' esperjenza fl - immaniġjar ta' disturbi fit- tħarrik u/ jew dimenzja.
Radiopharmaceutical agents should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides within a designated clinical setting.
Sustanzi radjufarmaċewtiċi għandhom jintużaw biss minn personàl kwalifikat bl- awtorizzazzjoni xierqa tal- gvern għall- użu u l - immaniġjar ta 'radjunuklidi f' ambjent kliniku apposta.
DaTSCAN is a 5% (v/ v) ethanolic solution for intravenous injection and should be used without dilution.
DaTSCAN huwa 5% (v/ v) soluzzjoni etanolika għall- injezzjoni fil- vina u għandu jintuża mingħajr ma jkun dilwit.
Clinical efficacy has been demonstrated across the range 111-185 MBq.
L- effikaċja klinika ntweriet fil- limiti ta '111 - 185 MBq.
In the event of overdosage, refer to section 4.9.
M' għandekx taqbeż il- 185 MBq u m' għandekx tużah meta l- attività hija inqas minn 110 MBq, Fil- każ ta 'doża eċċessiva, irreferi għal taqsima 4. 9.
To minimise the potential for pain at the injection site during administration, a slow intravenous injection (not less than 15-20 seconds) via an arm vein is recommended.
2 Biex jiġi minimizzat il- potenzjal ta 'wġigħ fis- sit ta' l- injezzjoni waqt li jkun qed jiġi injettat l - prodott, hu rakkomandat li l- injezzjoni fil- vina tingħata bil- mod (mhux inqas minn 15- 20 sekonda) minn ġo vina tad- driegħ.
2 Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium iodide 1-4 hours prior to injection and again 12-24 hours post-injection of DaTSCAN.
Il- pazjenti jridu jieħdu kura xierqa li tibblokka t- tirojde qabel l- injezzjoni biex jitnaqqas t - teħid ta ’ l- Iodone radjuattiv mit- tirojde, ngħidu aħna billi jingħata bejn wieħed u ieħor 120 mg patassium iodide mill- ħalq bejn 1 u 4 sigħat qabel l- injezzjoni u jerga 'jingħata bejn 12 u 24 siegħa wara l- injezzjoni ta' DaTSCAN.
SPECT imaging should take place between three and six hours post-injection.
Il- viżjoni SPECT għandha ssir bejn tliet u sitt sigħat wara l- injezzjoni.
Images should be acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the 159 keV photopeak and a ± 10% energy window.
Ir- ritratti jittieħdu b' kamera gamma li jkollha kollimatur ta 'reżoluzzjoni għolja u kalibrata bl- użu tal- 159keV bħala l- ogħla livell ta' dawl u tieqa ta 'enerġija ta ’ ± 10%.
Angular sampling should preferably be not less than 120 views over 360 degrees.
Preferibbilment għandhom jittieħdu mhux inqas minn 120 ritratt f’ madwar 360 grad.
For high resolution collimators the radius of rotation should be consistent and set as small as possible (typically 11-15cm).
Għall- kollimaturi b' reżoluzzjoni għolja r - radju tar- rotazzjoni għandu jkun konsistenti u jiġi ssettjat żgħir kemm jista 'jkun (tipikament 11- 15cm).
Experimental studies with a striatal phantom, suggest that optimal images are obtained with matrix size and zoom factors selected to give a pixel size of 3.5-4.5 mm for those systems currently in use.
Studji sperimentali b' kontenitur radjuattiv għall- provi tar- ritratti tal- korpus striatum, jissuġġerixxu li l- aħjar ritratti jittieħdu meta d- daqs tal- matrici u l- fatturi taż - 'zoom' jagħtu daqs tal- pixel ta 'bejn 3. 5 u 4. 5 mm għas- sistemi li qed jintużaw bħalissa.
A minimum of 500k counts should be collected for optimal images.
Għandhom jinġabru mill- inqas 500k ta ’ raġġi għall- aħjar ritratti.
Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity.
Stampi normali huma karatterizzati minn żewġ partijiet simetriċi forma ta 'felli ta' l- istess intensita`.
Abnormal images are either asymmetric or symmetric with unequal intensity and/ or loss of crescent.
Stampi li mhumiex normali, jew ma jkunux simetriċi, jew ikunu simetriċi imma b' intensita` differenti u/ jew mingħajr il - forma ta 'felli.
DaTSCAN is not recommended for use in children or adolescents due to a lack of data on safety and efficacy.
DaTSCAN mhux rakkomandat għall- użu fit- tfal jew l- adoloxxenti, peress li m' hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Pregnancy.
Tqala.
This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.
Dan il- prodott farmaċewtiku jista 'jiġi akkwistat, jintuża u jingħata biss minn persuni awtorizzati f' ambjenti kliniċi apposta.
Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations.
L- akkwist, il- ħażna, l- użu, it- trasferiment u r- rimi tiegħu jridu jsiru skond ir- regolamenti u l- liċenzji xierqa ta 'l- organizzazzjonijiet uffiċjali lokali kompetenti.
Formal studies have not been carried out in patients with significant renal or hepatic impairment.
Ma sarux studju formali f' pazjenti b’ indeboliment sinifikanti tal- kliewi jew tal- fwied.
In the absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic impairment.
Fin - nuqqas ta 'tagħrif, DaTSCAN mhux rakkomandat f' każijiet ta' indeboliment moderat jew sever tal- kliewi jew tal- fwied.
This medicinal product contains 5% volume ethanol (alcohol), up to 197 mg per dose, equivalent to 5 ml beer, 2 ml wine.
Dan il- prodott mediċinali fih 5% tal- volum ta ’ ethanol (alkoħol), li jitla għal 197 mg għal kull doża, li hu ekwivalenti għal 5 ml ta ’ birra jew 2 ml imbid.
Harmful for those suffering from alcoholism.
Hu ta ’ ħsara għal dawk li jbatu mill- alkoħoliżmu.
To be taken into account in high-risk groups such as patients with liver disease or epilepsy.
Wieħed irid jikkonsidra dan f’ każ ta ’ gruppi li qegħdin f’ riskju għoli bħal f’ pazjenti li jbatu mill- mard tal- fwied jew huma epilettiċi.
No interaction studies have been performed in humans.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku tal - prodott fil- bnedmin.
Ioflupane binds to the dopamine transporter.
Ioflupane jingħaqad mat- trasportatur tad- dopamine.
Medicines that bind to the dopamine transporter with high affinity may therefore interfere with DaTSCAN diagnosis.
Dawn
These include amfetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine and sertraline.
3 jinkludu amphetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine u sertraline.
Medicines shown during clinical trials not to interfere with DaTSCAN imaging include amantadine, trihexyphenidyl, budipine, levodopa, metoprolol, primidone, propranolol and selegiline.
Mediċini li fil- provi kliniċi wrew li ma jxekklux il- viżjoni permezz tad- DaTSCAN jinkudu amantadine, benzhexol, budipine, levodopa, metoprolol, primidone, propranolol u selegiline.
Dopamine agonists and antagonists acting on the postsynaptic dopamine receptors are not expected to interfere with DaTSCAN imaging and can therefore be continued if desired.
Agonisti u antagonisti tad- dopamine li jaġixxu fuq ir- reċetturi postsinettiċi (postsynaptic) tad - dopamine mhux mistennija li jxekklu l- viżjoni bid- DaTSCAN u għalhekk jistgħu jitkomplew skond ix- xewqa.
Drugs shown in animal studies not to interfere with DaTSCAN imaging include pergolide.
Mediċini li fi studji fuq l- annimali ntwerew li ma jxekklux il- viżjoni ta 'DaTSCAN jinkludu pergolide.
DaTSCAN is contraindicated in pregnancy.
DaTSCAN m' għandux jittieħed waqt it- tqala.
Animal reproductive toxicity studies have not been performed with this product.
Ma sarux studji dwar l- effett tossiku fuq ir - riproduzzjoni fl- annimali.
Radionuclide procedures carried out on pregnant women also involve
Il- proċeduri radjunuklidi li jsiru fuq nisa tqal jinvolvu wkoll dożi ta 'radjazzjoni għall- fetu.
Administration of ioflupane (123I) at a dose of 185 MBq results in an absorbed dose to the uterus of 3.0 mGy.
Meta jingħata ioflupane (123I) b' doża ta '185 MBq, id- doża li jassorbi l- utru hija ta' 3. 0 mGy.
A radiation dose above 0.5 mGy would be regarded as a potential risk to the foetus.
Doża ta 'radjazzjoni ogħla minn 0. 5 mGy għandha titqies bħala potenzjalment ta' riskju għall- fetu.
Where it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy.
Meta jkun neċessarju li jingħataw prodotti mediċinali radjuattivi lil nisa li jista 'jkollhom it - tfal, trid dejjem tinkiseb informazzjoni dwar t- tqala.
Any woman who has missed a period should be assumed pregnant until proven otherwise.
Kull mara li ma jkunx ġieha l- pirjid għandha tiġi meqjusa daqs li kieku tqila sakemm jiġi ppruvat li dan mhux minnu.
Where uncertainty exists, it is important that radiation exposure should be the minimum consistent with achieving satisfactory imaging.
Meta jkun hemm inċertezza, huwa importanti li l- espożizzjoni għar- radjazzjoni tkun il- minimu possibbli li tista ’ tagħti viżjoni sodisfaċenti.
Alternative techniques which do not involve ionising radiation should be considered.
Għandhom jitqiesu tekniki alternattivi li ma jinvolvux radjazzjoni ijonizzanti.
It is not known whether ioflupane (123I) is excreted in human milk.
Mhux magħruf jekk ioflupane (123I) jiġiex eliminat fil- ħalib ta 'l- omm.
Before administering a radioactive medicinal product to a breast-feeding mother, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast-feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of radioactivity in breast milk.
Qabel ma 'prodott mediċinali radjuattiv jingħata lil omm li qed tredda', irid jitqies jekk l- istħarriġ jistax jiġi pospost sakemm l- omm tieqaf tredda 'u jekk saritx l- aħjar għażla dwar il- radjufarmaċewtiku, meta wieħed jikkonsidra t- tnixxija tar- radjuattività mill- ħalib ta' l- omm.
If administration is considered necessary, breast-feeding should be interrupted for 3 days and substituted by formula feeding.
Jekk l- għoti jiġi kkonsidrat li hu meħtieġ, it- treddigħ għandu jiġi interrot għal 3 t’ ijiem u għandu jiġi sostitwit bil- ħalib tat- trab.
During this time, breast milk should be expressed at regular intervals and the expressed feeds should be discarded.
Matul dan il- perijodu, il- ħalib tas- sider ta ’ l- omm għandu jibqa ’ jiġi magħsur f’ intervalli regolari bil- ħalib magħsur jiġi mormi.
No serious adverse reactions related to DaTSCAN administration have been reported.
Ma ġewx irrapurtati reazzjonijiet avversi relatati ma ’ l- għoti ta 'DaTSCAN.
The following common (≥ 1/ 100 to < 1/ 10) side effects are recognised for DaTSCAN:
L- effetti avversi (≥1/ 100 sa < 1/ 10) li ġejjin huma rikonoxxuti għal DaTSCAN:
Metabolism and nutrition disorders Appetite increased
Mard marbut mal- Metaboliżmu u Nutrizzjoni Żieda fl- aptit
Nervous system disorders Headache Formication (paraesthesia)
Mard tas- Sistema Nervuża Uġigħ ta ’ ras Formikazzjoni (paraestesija)
Ear and labyrinth disorders Vertigo
Mard fil- Widnejn u s- Sistema Labrintika Vertigo
The following uncommon (≥ 1/ 1,000 to ≤ 1/ 100) side effects are recognised for DaTSCAN:
L- effeti mhux komuni (≥1/ 1, 000 sa < 1/ 100) li ġejjin huma rikonoxxuti għal DaTSCAN:
For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit.
Mard Ġenerali u Kundizzjonijiet ta ’ Mnejn Jittieħed
4 4.9 Overdose
4 Uġigħ fil- sit ta ’ l- injezzjoni (uġigħ kbir wara l- għoti f’ vini żgħar)
In cases of overdosage of radioactivity, frequent micturition and defaecation should be encouraged in order to minimise radiation dosage to the patient.
Għal kull pazjent, l- espożizzjoni għal radjazzjoni ijonizzanti trid tkun ġustifikata skond kemm tista 'tkun ta' benefiċċju.
Care should be taken to avoid contamination from the radioactivity eliminated by the patient using such methods.
F' każijiet ta 'doża radjuattiva eċċessiva, il- pazjenti għandhom jiġu nkuraġġiti biex jagħmlu l - awrina u jippurgaw spiss biex id- doża ta' radjazzjoni fil- pazjent titnaqqas.
Diagnostic radiopharmaceutical for central nervous system imaging, ATC code:
Prodott radjuframaċewtiku dijanjostiku għall- viżjoni tas - sistema nervuża ċentrali, Kodiċi ATC:
Due to the low quantities of ioflupane injected, pharmacological effects are not expected following intravenous administration of DaTSCAN at the recommended dosage.
Minħabba li jiġu njettati kwantitajiet żgħar ta 'ioflupane, mhux mistenni li jkun hemm effetti farmakoloġiċi wara l- għoti tad- doża rakkomandata ta' DaTSCAN fil- vina.
Ioflupane is a cocaine analogue.
Ioflupane huwa analogu tal- kokaina.
Studies in animals have shown that ioflupane binds with high affinity to the presynaptic dopamine transporter and so radiolabelled ioflupane (123I) can be used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.
Studji fuq l- annimali wrew li ioflupane jintrabat b’ affinità qawwija mat- trasportatur tad- dopamine presinattika u għalhekk ioflupane (123I) radjutikkettat jista 'jintuża bħala markatur alternattiv biex jeżamina l- integrita` tan- newroni dopaminerġiċi nigristrijatali.
Ioflupane also binds to the serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.
Ioflupane jintrabat ukoll mat- trasportatur ta 'serotonin fuq newroni 5- HT imma b' affinità anqas qawwija tar- rabta inqas (bejn wieħed u ieħor 10 darbiet).
There is no experience in types of tremor other than essential tremor.
M' hemmx esperjenza dwar it- tipi ta 'tregħid ħlief tregħid essenzjali.
Clinical studies in patients with dementia with Lewy bodies
Studji kliniċi f’ pazjenti bid- dimenzja b’ korpi Lewy
In a pivotal clinical trial including evaluation of 288 subjects with dementia with Lewy bodies (DLB) (144 subjects), Alzheimer’ s disease (124 subjects), vascular dementia (9 subjects) or other (11 subjects), the results of an independent, blinded visual assessment of the DaTSCAN images were compared to the clinical diagnosis as determined by physicians experienced in the management and diagnosis of dementias.
Fi prova klinika ewlenija li kienet tinkludi l- evalwazzjoni ta ’ 228 pazjent b’ dimenzja b’ korpi Lewy (DLB) (144 pazjent), il- marda ta ’ Alzheimer (124 pazjent), dimenzja vaskulari (9 pazjenti) jew oħrajn (11- il pazjent), ir- riżultati ta ’ immaġini DaTSCAN indipendenti u ta ’ l - eżami viżwali b’ inkonsapevolezza ġew imqabbla mad- dijanjosi klinika kif stabbilit mit- tobba b’ esperjenza fil- ġestjoni u d- dijanjosi ta ’ dimenzji.
Clinical categorisation into the respective dementia group was based on a standardised and comprehensive clinical and neuropsychiatric evaluation.
Il- kategorizzazzjoni klinika fil- grupp rispettiv ta ’ dimenzja kienet ibbażżata fuq standardizzazzjoni u evalwazzjoni klinika komprensiva u newropsikjattrika.
The values for the sensitivity of DaTSCAN in determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to 91.4%.
Il- valuri għas- sensittività ta ’ DaTSCAN li jistabilixxu il - probabbiltà ta ’ DLB minn dak li mhux DLB kienu fil- firxa ta ’ bejn 75. 0% sa 80. 2% u bi speċifiċità minn 88. 6% sa 91. 4%.
The positive predictive value ranged from 78.9% to 84.4% and the negative predictive value from 86.1% to 88.7%.
Il- valur predikattiv pożittiv kien mifrux minn 78. 9% sa 84. 4% u l- valur predikattiv negattiv minn 86. 1% sa 88. 7%.
Analyses in which both possible and probable DLB patients were compared with non-DLB dementia patients demonstrated values for the sensitivity of DaTSCAN ranging from 75.0% to 80.2% and specificity from 81.3% to 83.9% when the possible DLB patients were included as non-DLB patients.
Analiżi li fihom kemm il- pazjenti possibbli u probabbli ta ’ DLB ġew imqabbla ma pazjenti li m’ għandhomx dimenzja b’ DLB urew valuri għas- sensittività ta ’ DaTSCAN li tvarja minn 75. 0% sa 80. 2% u bi speċifiċità minn 81. 3% sa 83. 9% meta l- pazjenti DLB possibbli ġew inklużi bħala pazjenti li mhumiex DLB.
The sensitivity ranged from 60.6% to 63.4% and specificity from 88.6% to 91.4% when the possible DLB patients were included as DLB patients.
Is- sensittività kienet mifruxa bejn 60. 6% sa 63. 4% u l- ispeċifiċità minn 88. 6% sa 91. 4% meta l- pazjenti li possibbilment kellhom DLB ġew inklużi bħala pazjenti bid- DLB.
5.2 Pharmacokinetic properties
5 5. 2 Tagħrif farmakokinetiku
Ioflupane (123I) is cleared rapidly from the blood after intravenous injection; only 5% of the administered activity remains in whole blood at 5 minutes post-injection.
Ioflupane (123I) jitneħħa malajr mid- demm wara injezzjoni fil- vina; 5% biss ta 'l- attivita` li tingħata tibqa' fid- demm sħiħ, 5 minuti wara l- injezzjoni.
Uptake in the brain is rapid, reaching about 7% of injected activity at 10 minutes post-injection and decreasing to 3% after 5 hours.
Il- prodott malajr imur fil- moħħ, u jilħaq 7% ta 'l- attivita` injettata 10 minuti wara l- injezzjoni u jonqos għal 3% wara 5 sigħat.
About 30% of the whole brain activity is attributed to striatal uptake.
Madwar 30% ta 'l- attivita` kollha fil- moħħ isseħħ minħabba l- ammont li jibqa' fil- korpus striatum.
At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion calculated at approximately 14%.
48 siegħa wara l- injezzjoni, bejn wieħed u ieħor 60% tar- radjuattivita` li tiġi njettata titneħħa fl- awrina, u hu kkalkulat li 14% jitneħħa fl- ippurgar.
Acute toxicity studies employing ioflupane at dosage levels of 0.06 mg/ kg, in excess of 6,500 times the maximum human (70 kg) single dose on a bodyweight basis, failed to reveal any mortality or signs of systemic toxicity in rats or rabbits.
Studji b' ioflupane dwar it- tossiċita` akuta b' livelli ta 'doża ta' 0. 06 mg/ kg, 6, 500 darba d- doża massima għall- bniedem (70 kg) fuq bażi ta 'piż, ma rriżultawx f' imwiet jew f’ sinjali ta ’ tossicita` sistemika fil- firien jew fil- fniek.
In 14 day repeat dose studies no evidence of toxicity was observed in rats or rabbits following daily doses of 0.6 mg/ kg ioflupane, more than 65,000 times the maximum
Fi studju li dam sejjer 14- il ġurnata, fejn ngħataw dożi ripetuti, ma ġiet osservata l- ebda evidenza ta 'tossiċita` fil- firien jew il- fniek wara dożi ta' kuljum ta '0. 6 mg/ kg ioflupane, li hija iktar minn 65, 000 darba d- doża massima għall- bniedem (70 kg) fuq bażi ta' piż.
Behavioural effects due to pharmacological activity were observed in these studies.
F' dawn l- istudji ġew osservati effetti fuq l- imġieba minħabba l - attivita` farmakoloġika.
Studies on reproductive toxicity have not been conducted.
Ma sarux studji dwar l- effett tossiku fuq ir- riproduzzjoni.
Ioflupane showed no evidence of mutagenic potential in in vitro or in vivo mutagenicity studies.
Ioflupane ma wera l- ebda evidenza ta 'potenzjal mutaġeniku fi studji mutaġeniċi in vitro jew in vivo.
Studies to assess the carcinogenic potential of ioflupane have not been performed.
Ma sarux studji biex iqisu l- potenzjal ta 'ioflupane għall- kanċer.
Acetic acid Sodium acetate Ethanol Water for injections
Acetic acid, Sodium acetate, Ethanol, Ilma għall- injezzjonijiet.
2.5 ml presentation:
Preżentazzjoni tat- 2. 5 ml:
7 hours from the activity reference time stated on the label (35 hours from the end of manufacture).
7 sigħat miż- żmien ta 'attività ta ’ referenza kif imfisser fuq it - tikketta (35 siegħa mit- tmiem tal- manifattura).
5.0 ml presentation:
Preżentazzjoni tal- 5. 0 ml:
20 hours from the activity reference time stated on the label (48 hours from the end of manufacture).
20 siegħa miż- żmien ta 'attività ta ’ referenza kif imfisser fuq it - tikketta (48 siegħa mit- tmiem tal- manifattura).
Do not store above 25oC.
Taħżinx f' temperatura 'l fuq minn 25°C.
The product is supplied in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.
Il- prodott jiġi fi fjala waħda tal- ħġieġ bla kulur ta '10 ml issiġillata b' tapp tal- gomma u siġill fuq kollox tal- metall.
The 2.5 ml presentation contains 185 MBq at reference in 2.5 ml of solution.
Il- preżentazzjoni tat- 2. 5 ml fiha 185 MBq mill- ħin ta 'referenza f' soluzzjoni ta' 2. 5 ml.
The 5.0 ml presentation contains 370 MBq at reference in 5.0 ml of solution.
Il- preżentazzjoni tal- 5 ml fiha 370 MBq mill- ħin ta 'referenza f' soluzzjoni ta' 5 ml.
6.6 Special precautions for disposal
6 6. 6 Prekawzjonijiet speċjali għar- rimi
Normal safety precautions for handling radioactive materials should be observed.
Għandhom jiġu osservati l- prekawzjonijiet ta 'sigurezza normali għall- immaniġġjar tal - materjal radjuattiv.
After use, all materials associated with the preparation and administration of radiopharmaceuticals, including any unused product and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance with the conditions specified by the local competent authority.
Wara l- użu, il- materjal kollu assoċjat mal- preparazzjoni u l- għoti tar - radjufarmaċewtiċi, inkluż xi parti mill- prodott li għadha mhix użata u l- kontenitur tiegħu, għandhom jiġu dekontaminati jew meqjusa bħala skart radjuattiv u mormija skond il - kondizzjonijiet speċifikati mill- awtorità lokali kompetenti.
Contaminated material must be disposed of as radioactive waste via an authorised route.
Materjal kontaminat għandu jintrema b' mod awtorizzat bħala skart radjuattiv.
GE Healthcare Limited Little Chalfont Bucks HP7 9NA United Kingdom
GE Healthcare Limited Little Chalfont Bucks HP7 9NA Renju Unit
MARKETING AUTHORISATION NUMBERS
NUMRI TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
27 July 2000 Date of last renewal:
27 ta 'Lulju 2000 Data ta ’ l- aħħar tiġdid:
27 July 2005
27 ta 'Lulju 2005
11 DOSIMETRY
DOŻIMETRIJA
Iodine-123 has a physical half-life of 13.2 hours.
Iodine- 123 għandu half life fiżika ta’ 13. 2 sigħat.
It decays emitting gamma radiation with a predominant energy of 159 keV and X-rays of 27 keV.
Jitmermer waqt li jarmi radjazzjoni gamma b’ enerġija predominanti ta '159 keV u raġġi- X ta' 27 keV.
The estimated absorbed radiation doses to an average adult patient (70 kg) from intravenous injection of ioflupane (123I) are listed below.
L- istimi tad- dożi tar- radjazzjoni assorbiti f' pazjent adult medju (70 kg) minn injezzjoni ta 'ioflupane (123I) jidhru hawn taħt.
The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (Iodine-123 is a known Auger electron emitter).
Il- valuri huma kkalkulati billi nassumu li l- borża ta 'l- urina qed titbattal f' intervalli ta' 4. 8 sigħat u l- imblukkar tat- tirojde qed isir b' mod xieraq.
Frequent bladder emptying should be encouraged after dosing to minimise radiation exposure.
Wara li tingħata d- doża għandu jiġi inkoraġġit li l- pazjent jagħmel l- urina b' mod frekwenti biex l- espożizzjoni għar- radjazzjoni tkun mill - inqas.
7 Absorbed radiation dose Target Organ μ Gy/ MBq Adrenals Brain Breasts Gallbladder wall Lower large intestine wall Small intestine Stomach Upper large intestine wall Heart wall Kidneys Liver Lungs Muscle Ovaries Pancreas Bone marrow Bone surfaces Skin Spleen Testes Thymus Thyroid Urinary bladder wall Uterus Total body
7 Organu fil- mira
13.1 18.1 8.0 25.7 42.4 20.6 11.4 38.1 13.1 11.1 28.3 42.5 9.6 17.0 13.2 9.8 17.4 6.3 10.6 8.8 10.3 9.2 53.5 16.3 11.5
Doża ta 'radjazzjoni assorbita μGy/ MBq
Effective Dose
Adrenali Moħħ Sider Rita tal- borża tal- marrara Rita tal- parti t' isfel tal- musrana l- kbira Musrana ż- żgħira Stonku Rita tal- parti ta 'fuq tal- musrana l- kbira Rita tal- qalb Kliewi Fwied Pulmuni Muskoli Ovarji Frixa Mudullun ta' l- għadma Uċuh ta 'l- għadam Ġilda Milsa Testikoli Timu Tirojde Ħajt tal- borża ta' l- urina Utru Il- ġisem kollu Doża effettiva
23.5
13. 1 18. 1 8. 0 25. 7 42. 4 20. 6 11. 4 38. 1 13. 1 11. 1 28. 3 42. 5 9. 6 17. 0 13. 2 9. 8 17. 4 6. 3 10. 6 8. 8 10. 3 9. 2 53. 5 16. 3 11. 5 23. 5 μSv/ MBq
The effective dose (E) resulting from administration of a 185 MBq dose of DaTSCAN injection is 4.35 mSv (per 70 kg individual).
Id- doża effettiva (E) li tirriżulta meta tingħata doża ta 'DaTSCAN ta' 185 MBq f' injezzjoni hija ta '4. 35 mSv (għal kull individwu ta' 70 kg).
The above data are valid in normal pharmacokinetic behaviour.
It- tagħrif ta 'hawn fuq huwa validu fil- każ ta' mġieba farmakokinetika normali.
When renal or hepatic function is impaired, the effective dose and the radiation dose delivered to organs might be increased.
Meta l- funzjoni tal- kliewi jew tal- fwied ma tkunx normali, d- doża effettiva u d- doża ta 'radjazzjoni li tasal fl- organi tista ’ tiżdied.
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
STRUZZJONIJIET GĦALL- PREPARAZZJONI TA ’ PRODOTTI RADJUFARMAĊEWTIĊI
See also section 6.6.
Ara ukoll sezzjoni 6. 6.
8 ANNEX II
8 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
SID L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL - HRUĠ TAL- LOTT
Den Dolech 2 NL-5612 AZ, Eindhoven The Netherlands
Den Dolech 2 NL- 5612 AZ, Eindhoven L- Olanda
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L - UŻU IMPOSTI FUQ SID L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata bir- riċetta ristretta tat- tabib (Ara Anness I:
Summary of Product Characteristics, Section 4.2).
Karatteristiċi tal - Prodott fil- Qosor, 4. 2)
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L - UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
10 ANNEX III
10 ANNESS III
12 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
12 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
5.0 ml presentation
preżentazzjoni tal- 5. 0 ml
DaTSCAN 74 MBq/ ml solution for injection.
DaTSCAN 74 MBq/ ml soluzzjoni għall- injezzjoni.
Ioflupane (123I) 74 MBq/ ml at activity reference time.
Ioflupane (123I) 74 MBq/ ml mill- ħin ta 'riferiment ta ’ l- attività.
Ioflupane (0.07– 0.13 µg/ ml).
Ioflupane (0. 07– 0. 13 µg/ ml).
5% ethanol, acetic acid, sodium acetate, water for injections.
5% ethanol, acetic acid, sodium acetate, ilma għall- injezzjonijiet.
5.0 ml Solution for injection
5. 0 ml Soluzzjoni għall- injezzjoni
Intravenous use.
Użu għal ġol- vini
Keep out of reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
20 h post-ref.
20 h wara l- ħin ta ’ riferiment.
370 MBq/ 5.0 ml at 2300 CET on DD/ MM/ YYYY
370 MBq/ 5. 0 ml fi 2300 CET fil- JJ/ XX/ SSSS
Do not store above 25°C.
Taħżinx f' temperatura 'l fuq minn 25°C.
Handling and disposal – see package leaflet.
Immaniġar u rimi - ara l- fuljett ta ’ tagħrif.
GE Healthcare Limited Little Chalfont HP7 9NA UK
GE Healthcare Limited Little Chalfont HP7 9NA Renju Unit
Lot :< XXXXXXX >
LOTT: < XXXXXXX >
14 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
14 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Ioflupane (123I) 74 MBq/ ml
DaTSCAN 74 MBq/ ml soluzzjoni għall- injezzjoni Ioflupan (123I) 74 MBq/ ml
370 MBq/ 5.0 ml Ioflupane (123I) at 2300 CET on DD/ MM/ YYYY.
370 MBq/ 5. 0 ml Ioflupane fi 2300 CET fil- JJ/ XX/ SSSS.
2.5 ml presentation
preżentazzjoni tat- 2. 5 ml
DaTSCAN 74 MBq/ ml solution for injection Ioflupane (123I) 74 MBq/ ml
DaTSCAN 74 MBq/ ml soluzzjoni għall- injezzjoni Ioflupane (123I) 74 MBq/ ml
2.5 ml Solution for injection
2. 5 ml Soluzzjoni għall- injezzjoni
Keep out of reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal
7 h post-ref.
7 h wara l- ħin ta ’ riferiment.
185 MBq/ 2.5 ml at 1200 CET on DD/ MM/ YYYY
185 MBq/ 2. 5 ml fi 1200 CET fil- JJ/ XX/ SSSS
Handling and disposal – see package leaflet.
Immaniġjar u rimi - ara l- fuljett ta ’ tagħrif
17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
185 MBq/ 2.5 ml Ioflupane (123I)at 1200 CET on DD/ MM/ YYYY
185 MBq/ 2. 5 ml Ioflupane (123I) fi 1200 CET fil- JJ/ XX/ SSSS.
19 PACKAGE LEAFLET:
19 FULJETT TA ’ TAGĦRIF:
DaTSCAN 74 MBq/ ml solution for injection Ioflupane (123I)
DaTSCAN 74 MBq soluzzjoni għall- injezzjoni Ioflupane (123I)
Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
Aqra dan il- fuljett kollu, qabel tibda tuża din il- mediċina.
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to others.
Tista ’ tagħmilhom
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What DaTSCAN is and what it is used for 2.
X’ inhu DaTSCAN u għalxiex jintuża 2.
Before you use DaTSCAN 3.
Qabel ma tieħu DaTSCAN 3.
How DaTSCAN is used 4.
Kif jittieħed DaTSCAN 4.
How DaTSCAN is stored 6.
Kif jinħażen DaTSCAN 6.
WHAT DaTSCAN IS AND WHAT IT IS USED FOR
X’ INHU DaTSCAN U GĦALXIEX JINTUŻA
DaTSCAN contains Ioflupane (123I) which is used to help identify (diagnose) conditions in the brain.
DatSCAN fih Ioflupane (123I) li jintuża biex jidentifika (jiddijanjostika) kundizzjonijiet fil - moħħ.
It belongs to a group of medicines called “ radiopharmaceuticals”, which contain a small amount of radioactivity. • When a radiopharmaceutical is injected, it collects in a specific organ or area of the body for a short time. • Because it contains a small amount of radioactivity it can be detected from outside the body using special cameras. • A picture, known as a scan, can be taken.
• Meta prodott radjufarmaċewtiku jiġi injettat, huwa jinġabar f’ organu jew erja speċifika tal- ġisem għal ftit żmien. • Peress li fih ammont żgħir ta 'radjoattività jista' jiġi osservat minn barra l- ġisem permezz ta ’ kameras speċjali. • Jista ’ jittieħed ritratt li jissejjaħ skan.
This scan will show exactly where the radioactivity is inside the organ and the body.
Dan l- iskan juri eżatt fejn tinsab ir- radjoattività fl - organu u l- ġisem.
This can give the doctor valuable information about how that organ is working.
Dan jista 'jagħti lit- tabib informazzjoni prezzjuża dwar l- istruttura u kif l- organu qed jaħdem
When DaTSCAN is injected into you, it is carried around the body in the blood.
Meta DaTSCAN jiġi njettat ġo fik, jinġarr madwar il- ġisem fid- demm u jinġema.
It collects in a small area of your brain.
Hu jinġema 'f' parti żgħira tal- moħħ.
Changes in this area of the brain occur in: • Parkinsonism (including Parkinson’ s disease) and • dementia with Lewy bodies.
• Il- Parkinsoniżmu (li jinkludi l- marda ta ’ Parkinson) u • id- dimenzja bil- korpi ta ’ Lewy.
A scan will give your doctor information about any changes in this area of your brain.
Skan ser tagħti lit- tabib informazzjoni dwar bidliet li setgħu seħħew f' din il- parti tal- moħħ.
Your doctor may feel that the scan would help in finding out more about your condition and deciding on possible treatment.
It- tabib tiegħek jista 'jħoss li l- informazzjoni li l- iskan tkun tista ’ tgħin aktar dwar il- kondizzjoni tiegħek u biex tittieħed deċiżjoni dwar it- trattament possibbli.
This medicine is used for diagnostic use only.
Din il- mediċina tintuża biss għal użu dijanjostiku.
It is used only to identify illness.
Tiġi wżata biex tidentifika l- mard.
BEFORE YOU USE DaTSCAN
QABEL MA TIEĦU DaTSCAN
Do not use DaTSCAN if:
Tieħux DaTSCAN
• you are pregnant • you are allergic (hypersensitive) to iodide or any of the other ingredients of DaTSCAN (see Section 6:
• jekk int tqila • jekk tbati minn sensittività eċċessiva (allerġija) għall- jodju jew għal xi wieħed mis- sustanzi l- oħra ta ’ DaTSCAN (ara Sezzjoni 6.
Further Information).
Aktar Tagħrif).
Take special care with DaTSCAN
Oqgħod attent ħafna b’ DaTSCAN
DaTSCAN is not recommended for: • children or adolescents • people with moderate or severe problems with their kidneys or liver
DaTSCAN mhux rakkomandat fuq • tfal jew addoloxxenti • persuni bi problemi moderati jew serji fil- kliewi jew il- fwied tagħhom.
DaTSCAN will always be used in a hospital or a similar place.
Hemm liġijiet stretti dwar l- użu, l- immaniġġjar u r- rimi tar- radjoattività, DaTSCAN dejjem jintuża fi sptar jew post simili.
It will only be handled and given to you by people who are trained and qualified to use it safely.
Jista 'jiġi manipulat u mogħti biss lilek minn persuni li huma mħarrġa u kwalifikati biex jużah b' sigurtà.
They should tell you anything you need to do for the safe use of this medicine.
Għandhom jgħidulek dak kollu li għandek bżonn tkun taf dwar l- użu sigur ta ’ din il- mediċina.
Taking other medicines
Meta tuża mediċini oħra
Some medicines or substances can affect the way that DaTSCAN works.
Xi medicini u sustanzi jistgħu jaffettwaw kif jaħdem DatSCAN.
These include: • buproprion • benzatropine • mazindol • sertraline • methylphenidate • phentermine • amfetamine • cocaine
Dawn jinkludu: • buproprion • benzatropine • mazindol • sertraline • methylphenidate • phentermine • amfetamine • cocaine
Other medicines used to treat Parkinson’ s disease (like levodopa) do not affect how DaTSCAN works.
Mediċini oħra li jintużaw biex jikkuraw il- marda ta 'Parkinson, bħal levodopa, ma jxekklux kif jaħdem DaTSCAN.
You can continue to take them.
Inti tista ’ tibqa ’ teħodhom.
Some medicines may reduce the quality of the picture obtained.
Xi mediċini jistgħu jnaqqsu l- kwalità tar- ritratt miksub.
The doctor may ask you to stop taking them for a short time before you receive DaTSCAN.
It- tabib jista ’ jistaqsik biex tieqaf teħodhom għal perijodu qasir qabel ma tirċievi DaTSCAN.
You should not have DaTSCAN if you are pregnant or think you may possibly be pregnant.
M’ għandux tieħu DatSCAN jekk inti tqila jew taħseb li possibilment inti tqila.
This is because the child may receive some of the radioactivity.
Dan minħabba li l- wild jista ’ jirċievi xi ftit mir- radjoattività.
Tell your doctor if you think you might be pregnant.
Għarraf lit- tabib tiegħek jekk taħseb li inti tqila.
If you are breast-feeding, your doctor may delay the use of DaTSCAN, or ask you to stop breast-feeding.
Jekk qed tredda ’, it- tabib tiegħek għandu mnejn jittardja l- użu ta ’ DaTSCAN, jew jitolbok 123 biex tieqaf tredda ’.
It is not known whether ioflupane (123I) (the active substance in DaTSCAN) is passed into breast milk. • You should not breast-feed your child for 3 days after DaTSCAN is given. • Instead use formula feed for your child.
• M’ għandekx tredda ’ lit- tarbija tiegħek sa 3 ijiem wara li jingħatalhek id- DaTSCAN. • Minflok uża l- ħalib tat- trabi għat- tifel/ tifla tiegħek.
Express your breast milk regularly and throw away any breast milk you have expressed. • You will need to continue to do this for 3 days, until the radioactivity is no longer in your body.
Għaddi l- ħalib tiegħek b’ mod regolari u armi l- ħalib tas- sider li tkun għaddejt. • Għandek mnejn ikollok tibqa ’ tagħmel hekk għal 3 ijiem, sakemm ir- radjoattività ma tibqax aktar f’ ġismek.
21 Driving and using machines
21 Sewqan u tħaddim ta ’ magni
DaTSCAN is not likely to affect your ability to drive or to use machines.
DaTSCAN mhux misteni li jaffettwa l- ħila tiegħek biex issuq jew biex tħaddem magni.