FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon: may affect up to 1 in 100 people - Increased appetite - Dizziness - Taste disturbance - Nausea - Dry mouth - Vertigo - A brief irritating feeling similar to ants crawling over your skin (formication) - Intense pain (or burning sensation) at the injection site.
Maltese: Mhux komuni: jista' jaffettwa sa persuna 1 minn kull 100 - Żieda fl-aptit - Sturdament - Disturbi fit-togħma - Dardir - ħalq xott - Sensazzjoni irritanti bħal qisu hemm in-nemel miexi fuq il-ġilda tiegħek formikazzjoni) - Uġigħ qawwi (jew sensazzjoni ta' ħruq) fis-sit tal-injezzjoni.
English: • In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy.
Maltese: • F'pazjenti adulti li jbatu bis-Sindromi ta' Parkinson li għadhom mhux ċerti klinikament, pereżempju dawk b'sintomi bikrin, biex jgħin jagħraf bejn Tregħid Essenzjali u Sindromi ta' Parkinson relatati mal-Marda ta' Parkinson idjopatika, Atrofija Multipla tas-Sistema u Paraliżi Progressiva Supranukleari.
English: EXP: 7 h post-ref. Ref.: 185 MBq/2.5 ml at 1200 CET on DD/MM/YYYY
Maltese: Ref.: 185 MBq/2.5 ml fi 1200 CET fil-JJ/XX/SSSS
English: 5 ml vial: 20 hours from the activity reference time stated on the label.
Maltese: Kunjett ta' 5 ml: 20 siegħa miż-żmien ta' attività ta' referenza kif imfisser fuq it-tikketta.
English: Gallbladder wall Gastrointestinal tract
Maltese: Rita tal-borża tal-marrara Passaġġ gastro-intestinali
English: Ioflupane also binds to the serotonin transporter on 5-HT neurons but with lower (approximately 10-fold) binding affinity.
Maltese: 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).
English: Luxembourg/Luxemburg GE Healthcare BVBA België/Belgique/Belgien Tél/Tel: +32 (0) 2 719 7410
Maltese: Luxembourg/Luxemburg GE Healthcare BVBA België/Belgique/Belgien
English: • The other ingredients are acetic acid, sodium acetate, ethanol and water for injections.
Maltese: • Is-sustanzi l-oħra huma acetic acid, sodium acetate, ethanol u ilma għall-injezzjonijiet.
English: 2.5 ml vial: 7 hours from the activity reference time stated on the label.
Maltese: Kunjett ta' 2.5 ml: 7 sigħat miż-żmien ta' attività ta' referenza kif imfisser fuq it-tikketta.
English: At 48 hours post-injection, approximately 60% of the injected radioactivity is excreted in the urine, with faecal excretion calculated at approximately 14%.
Maltese: 48 siegħa wara l-injezzjoni, bejn wieħed u ieħor 60% tar-radjuattivita` li tiġi njettata titneħħa flawrina, u hu kkalkulat li 14% jitneħħa fl-ippurgar.
English: This is about the same as 5 ml beer, or 2 ml wine.
Maltese: Dan hu ekwivalenti għal 5 ml ta' birra jew 2 ml inbid.
English: 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.
Maltese: 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%.
English: 2.5 or 5 ml solution in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.
Maltese: 2.5 ml jew 5 ml ta' soluzzjoni fi fjala waħda tal-ħġieġ bla kulur ta' 10 ml issiġillata b'tapp tal-gomma u siġill fuq kollox tal-metall.
English: Magyarország Radizone Diagnost-X Kft. Tel: +36 1 787-5720
Maltese: Kft. Tel: +36 1 787-5720
English: • benzatropine (used to treat Parkinson's disease)
Maltese: • benzatropine (jintuża għall-kura tal-marda ta' Parkinson)
English: Metabolism and nutrition disorders Uncommon: Appetite increased
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni: Żieda fl-aptit
English: GE Healthcare Bio-Sciences, S.A.U Tel: +34 91 663 25 00
Maltese: A.U Tel: +34 91 663 25 00
English: These include:
Maltese: Mhux magħruf:
English: Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity.
Maltese: Stampi normali huma karatterizzati minn żewġ partijiet simetriċi forma ta' felli ta' l-istess intensita`.
English: Children and adolescents DaTSCAN is not recommended for children aged 0 to 18 years
Maltese: Tfal u adolexxenti DaTSCAN mhuwiex rakkommandat għal: tfal li jkollhom minn 0 sa 18-il sena.
English: The camera pictures are usually taken 3 to 6 hours after the injection of DaTSCAN.
Maltese: Ir-ritratti tal-kamera ġeneralment jittieħdu bejn 3 u 6 sigħat wara l-injezzjoni ta' DaTSCAN.
English: Tel: +385 (0)1 61 70 280
Maltese: GE Healthcare d.o.o. Tel: +385 (0)1 61 70 280
English: DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum:
Maltese: DaTSCAN huwa indikat għall-osservazzjoni tan-nuqqas tat-terminali tan-newroni dopaminerġiċi li jiffunzjonaw fl-istrajatum:
English: Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.
Maltese: Espożizzjoni għal radjazzjoni jonizzanti hija relatata ma' induzzjoni ta' kanċer u potenzjal għal żvilupp ta' difetti ereditarji.
English: EXP: 20 h post-ref. Ref.: 370 MBq/5 ml at 2300 CET on DD/MM/YYYY
Maltese: Ref.: 370 MBq/5 ml fi 2300 CET fil-JJ/XX/SSSS
English: Common: may affect up to 1 in 10 people - Headache
Maltese: Komuni: jista' jaffettwa sa persuna 1 minn kull 10 - Uġigħ ta' ras
English: DaTSCAN is contraindicated in pregnancy (see section 4.3).
Maltese: L-ebda dejta mhi disponibbli (ara sezzjoni 4.4).
English: Ref.: Publication 128 of the Annals of ICRP (Radiation dose to Patients from Radiopharmaceuticals: A Compendium of Current Information Related to Frequently Used Substances, 2015
Maltese: Ref .: Pubblikazzjoni 128 tal-Annali ta' ICRP (Doża ta' radjazzjoni lill-Pazjenti minn Radjufarmaċewtiċi:
English: I) can be used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.
Maltese: I) radjutikkettat jista' jintuża bħala markatur alternattiv biex jeżamina l-integrita` tan-newroni dopaminerġiċi nigristrijatali.
English: • amfetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness); also a drug of abuse)
Maltese: • amfetamine (jintuża għall-kura ta' iperattività fit-tfal narkolepsija, (irqad eċċessiv)); jista' wkoll isir abbuż minn din il-mediċina)
English: This is normal practice with medicines like DaTSCAN.
Maltese: Din hija prattika normali b'mediċini bħal DaTSCAN.
English: Small intestine wall
Maltese: Disturbi gastro-intestinali
English: The safety and efficacy of DaTSCAN in children aged 0 to 18 years has not been established.
Maltese: Is-sigurta u l-effikaċja ta' DaTSCAN fi tfal min età ta' 0 u 18-il sena ma ġewx determinati s'issa.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu.
English: How DaTSCAN is used
Maltese: DaTSCAN 74
English: Common: Headache
Maltese: Komuni: Uġigħ ta' ras
English: • sertraline (used to treat depression (sadness))
Maltese: • sertraline (jintuża biex jikkura d-dipressjoni (dwejjaq))
English: 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.
Maltese: Studji sperimentali b'kontenitur radjuattiv għall-provi tar-ritratti tal-korpus striatum, jissuġġerixxu li l-aħjar ritratti jittieħdu meta ddaqs 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.
English: Resuscitative medicinal products and equipment (e.g. endotracheal tube and ventilator) have to be readily available.
Maltese: Prodotti mediċinali u tagħmir ta' risuxitazzjoni (eż. tubu endotrakeali u ventilatur) għandhom ikunu disponibbli fil-pront.
English: 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.
Maltese: 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.
English: The following undesirable effects are recognised for DaTSCAN:
Maltese: Jekk tingħata DaTSCAN aktar milli suppost:
English: Salivary glands Skin
Maltese: Twissija ġenerali
English: DaTSCAN 74 MBq/ml solution for injection Ioflupane (
Maltese: X'inhu DaTSCAN u għalxiex jintuża DatSCAN fih is-sustanza attiva ioflupane (
English: Clinical efficacy Clinical studies in patients with dementia with Lewy bodies
Maltese: Effikaċja klinika Studji kliniċi f'pazjenti bid-dimenzja b'korpi Lewy
English: General warning Normal safety precautions for handling radioactive materials should be observed.
Maltese: Għandhom jiġu osservati l-prekawzjonijiet ta' sigurezza normali għall-immaniġġjar tal-materjal radjuattiv.
English: Each 5 ml single dose vial contains 370 MBq ioflupane (
Maltese: Kull kunjett b'doża waħda fih 5 ml fih 370 MBq ta' ioflupane (
English: 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%.
Maltese: Il-valuri għas-sensittività ta' DaTSCAN li jistabilixxu il-probabbiltà ta' DLB minn dak li mhux DLB kienu filfirxa ta' bejn 75.0% sa 80.
English: • buproprion (used to treat depression (sadness))
Maltese: • buproprion (jintuża biex jikkura d-dipressjoni (dwejjaq))
English: Organ uptake
Maltese: Organu fil-mira
English: What DaTSCAN looks like and contents of the pack DaTSCAN is a 2.5 or 5 ml colourless solution for injection, supplied in a single colourless 10 ml glass vial sealed with a rubber closure and metal overseal.
Maltese: DaTSCAN hu soluzzjoni għall-injezzjoni ta' 2.5 jew 5 ml, bla kulur, fornut f'kunjett wieħed tal-ħġieġ bla kulur ta' 10 ml, issiġillat b'tapp tal-lastku u overseal tal-metall.
English: spol.
Maltese: INDIVIDWALI.
English: 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).
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal xi eċċipjenti elenkati fis-sezzjoni 6.1. - Tqala (ara sezzjoni 4.6).
English: Fertility No fertility studies have been performed.
Maltese: Fertilità Ma sarux studji dwar il-fertilità.
English: I) is cleared rapidly from the blood after intravenous injection; only 5% of the administered activity remains in whole blood at 5 minutes post-injection.
Maltese: I) jitneħħa malajr mid-demm wara injezzjoni fil-vina; 5% biss ta' l-attivita` li tingħata tibqa' fid-demm sħiħ, 5 minuti wara l-injezzjoni.
English: 12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Maltese: STRUZZJONIJIET GĦALL-PREPARAZZJONI TA' PRODOTTI RADJUFARMAĊEWTIĊI
English: Package leaflet: Information for the user
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih DaTSCAN
English: Each ml of solution contains ioflupane (
Maltese: Kull ml ta' soluzzjoni fih ioflupane (
English: Clear colourless solution.
Maltese: Ilma għall-injezzjonijiet.
English: This leaflet was last revised in <{MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency web site; http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu.
English: Medicines that bind to the dopamine transporter with high affinity may therefore interfere with DaTSCAN diagnosis.
Maltese: Għalhekk il-mediċini li jingħaqdu mat-trasportatur tad-dopamine b'affinità qawwija jistgħu ixekklu d-djanjosi bid-DaTSCAN.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains ioflupane (
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni fih ioflupane (
English: Bone surface
Maltese: Twissijiet u prekawzjonijiet
English: I) results in an absorbed dose to the uterus of 3.0 mGy.
Maltese: I), din tiġi assorbita fl-utru b'rata ta' 3.0 mGy. DaTSCAN hu kontraindikat waqt it-tqala (ara sezzjoni 4.3).
English: Studies in animals have shown that ioflupane binds with high affinity to the presynaptic dopamine transporter and so radiolabelled ioflupane (
Maltese: Studji fuq l-annimali wrew li ioflupane jintrabat b'affinità qawwija mat-trasportatur tad-dopamine presinattika u għalhekk ioflupane (
English: Breast
Maltese: Frixa
English: The above data are valid in normal pharmacokinetic behaviour.
Maltese: It-tagħrif ta' hawn fuq huwa validu fil-każ ta' mġieba farmakokinetika normali.
English: Non-clinical data for ioflupane reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina Dejta mhux klinika għal ioflupane ma turi ebda periklu speċjali għall-bnedmin fuq il-bażi ta' studji konvenzjonali ta' farmakoloġija tas-sikurezza, tossiċità u ġenotossiċità.
English: To minimise the potential for pain at the injection site during administration, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein is recommended.
Maltese: Biex jiġi minimizzat il-potenzjal ta' wġigħ fis-sit ta' linjezzjoni waqt li jkun qed jiġi injettat l-prodott, hu rakkomandat li l-injezzjoni fil-vina tingħata bilmod (mhux inqas minn 15 sa 20 sekonda) minn ġo vina tad-driegħ.
English: Thymus
Maltese: Rimettar
English: Ear and labyrinth disorders Uncommon: Vertigo
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Mhux komuni: Sturdament
English: Respiratory, thoracic and mediastinal disorders Not known: Dyspnea
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Mhux magħruf:
English: 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.
Maltese: DaTSCAN għandu jintuża biss f'pazjenti adulti riferuti minn tobba b'esperjenza fl-immaniġġjar ta' DaTSCAN għandu jintuża biss minn staff ikkwalifikat bl-awtorizzazzjoni xierqa tal-gvern għall-użu u l-manipulazzjoni ta' radionuclides fi sfond kliniku magħżul.
English: NAME OF THE MEDICINAL PRODUCT DaTSCAN 74 MBq/ml solution for injection
Maltese: • kokaina (xi kultant tintuża bħala anestetiku għal operazzjoni fl-imnieħer; jista' wkoll isir abbuż minn din il-mediċina)
English: Red marrow
Maltese: TAGĦRIF
English: Talk to your nuclear medicine doctor before using DaTSCAN if you have a moderate or severe problem with your kidneys or liver.
Maltese: Kellem lit-tabib tal-mediċina nukleari qabel tingħata DaTSCAN jekk għandek problemi moderati jew serji fil-kliewi jew il-fwied tagħhom.
English: Breastfeeding It is not known whether ioflupane (
Maltese: Mhux magħruf jekk ioflupane (
English: The substance that is used for radiolabelling SomaKit TOC is called gallium (
Maltese: Ga) tal-gallju (gallium (
English: Ga) chloride had a sensitivity and specificity of 100% and 89% respectively, and found a lesion detection rate of 75%.
Maltese: Ga) tal-gallju kellha sensittività u speċifiċità ta' 100% u 89% rispettivament, u sabu rata ta' detezzjoni tal-leżjonijiet ta' 75%.
English: The PET scan images are then taken 40 to 90 minutes later.
Maltese: L-immaġini tal-iscan PET jittieħdu minn 40 sa 90 minuta wara.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for SomaKit TOC can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal SomaKit TOC jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR for SomaKit TOC can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the number of patients with GEP-NETs is low, the disease is considered ‘rare', and SomaKit TOC was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 March 2015.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn GEP-NETs huwa baxx, il-marda hija kkunsidrata ‘rari', u SomaKit TOC ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fid-19 ta' Marzu 2015.
English: The studies included data from 970 patients.
Maltese: L-istudji kienu jinkludu data minn 970 pazjent.
English: This is a summary of the European public assessment report (EPAR) for SomaKit TOC.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal SomaKit TOC.
English: For localising the primary GEP-NET, one study showed that the medicine had a sensitivity of 45% compared with 10% in patients given another approved diagnostic medicine, indium (111In) pentetreotide, and this was confirmed by another study that showed that the former had better sensitivity.
Maltese: Għal-lokalizzazzjoni tal-GEP-NET primarju, studju minnhom wera li l-mediċina kellha sensittività ta' 45% meta mqabbla mal-10% f'pazjenti li ngħataw mediċina dijanjostika oħra approvata, indium (111In) pentetreotide, u dan ġie kkonfermat minn studju ieħor li wera li l-ewwel waħda kellha sensittività aħjar.
English: SomaKit TOC contains the active substance edotreotide.
Maltese: SomaKit TOC fih is-sustanza attiva edotreotide.
English: SomaKit TOC is a diagnostic medicine used in adult patients who are thought to have so-called welldifferentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Maltese: SomaKit TOC huwa mediċina dijanjostika użata f'pazjenti adulti li huma maħsuba li għandhom l-hekk imsejħa tumuri newroendokrinali gastroenteropankreatiċi (gastroenteropancreatic neuroendocrine tumours (GEP-NETs)) iddifferenzjati sewwa.
English: GEP-NETs are cancers which start in types of cells in the gut or pancreas that normally release hormones.
Maltese: GEP-NETs huwa kanċers li jibdew f'tipi ta' ċelloli fl-imsaren jew fil-frixa li normalment jirrilaxxaw l-ormoni.
English: The active substance in SomaKit TOC, edotreotide radiolabelled with gallium (68Ga) chloride, has a well established use in detecting GEP-NETs.
Maltese: Is-sustanza attiva f'SomaKit TOC, l-edotreotide radjotikkettata bil-klorur (68Ga) tal-gallju, għandha użu stabbilit sew fis-sejbien ta' GEP-NETs.
English: In four other comparative studies it was seen that the active substance in SomaKit TOC detected more tumours than did indium (111In) pentetreotide in the same patients.
Maltese: F'erba' studji komparattivi oħra, intwera li s-sustanza attiva f'SomaKit TOC sabet aktar tumuri minn kemm sab indium (111In) pentetreotide fl-istess pazjenti.
English: Other information about SomaKit TOC
Maltese: Informazzjoni oħra dwar SomaKit TOC
English: What are the risks associated with SomaKit TOC?
Maltese: X'inhuma r-riskji assoċjati ma' SomaKit TOC?
English: Why is SomaKit TOC approved?
Maltese: Għaliex ġie approvat SomaKit TOC?
English: SomaKit TOC is used with a technique called positron emission tomography (PET scan) to obtain images that locate the cancers.
Maltese: SomaKit TOC jintuża ma' teknika msejħa tomografija b'emissjoni ta' pożitroni (scan PET) biex jinkisbu immaġini li jsibu l-kanċers.
English: The company therefore provided information from many, mostly small, studies in the published literature to show the effectiveness of SomaKit TOC at detection.
Maltese: Il-kumpanija għalhekk ipprovdiet informazzjoni minn ħafna studji, li ħafna minnhom huma żgħar fil-letteratura ppubblikata biex turi l-effikaċja ta' SomaKit TOC fid-detezzjoni.
English: The active substance in SomaKit TOC, edotreotide, attaches specifically to receptors called somatostatin receptors on the surface of cells.
Maltese: Is-sustanza attiva f'SomaKit TOC, l-edotreotide, teħel speċifikament mar-riċetturi msejħa riċetturi ta' somatostatin fuq is-superfiċje taċ-ċelloli.
English: The medicine is not used directly, but must be ‘radiolabelled' before being injected, which means that it is tagged with a separate substance that emits small amounts of radiation.
Maltese: Il-mediċina ma tintużax direttament, iżda għandha tiġi “radjotikettata” qabel tiġi injettata, li jfisser li hija mmarkata b'sustanza separata li tarmi ammonti żgħar ta' radjazzjoni.
English: After SomaKit TOC is radiolabelled it emits a small amount of radiation which poses a low risk of cancer or hereditary abnormalities.
Maltese: Wara li SomaKit TOC jiġi radjotikkettat dan jarmi ammont żgħir ta' radjazzjoni li toħloq riskju baxx ta' kanċer jew anormalitajiet ereditarji.
English: For the full list of side effects or restrictions with SomaKit TOC, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji jew ta' restrizzjonijiet rrappurtati b'SomaKit TOC, ara l-fuljett ta' tagħrif.
English: The risks of side effects seemed to be low and the CHMP therefore decided that SomaKit TOC's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Ir-riskji ta' effetti sekondarji dehru li kienu baxxi u s-CHMP għalhekk iddeċieda li l-benefiċċji ta' SomaKit TOC huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The prepared medicine, radiolabelled with gallium (68Ga) chloride, attaches to these receptors on the GEP-NET cells.
Maltese: Ilmediċina ppreparata, radjotikkettata bil-klorur (68Ga) tal-gallju, teħel ma' dawn ir-riċetturi fuq iċ-ċelloli GEP-NET.
English: Some studies looked at the sensitivity of the PET scans (how well the scans identified patients who had GEP-NETs or their metastases), some analysed specificity (how reliable scans were at identifying subjects who had no GEP-NETs) and some looked at lesion detection rate (how good scans were at identifying the tumours).
Maltese: Xi studji ħarsu lejn is-sensittività taliscans PET (kemm l-iscans identifikaw tajjeb pazjenti li kellhom GEP-NETs jew il-metastasi tagħhom), xi wħud analizzaw l-ispeċifità (kemm l-iscans kienu affidabbli fl-identifikazzjoni ta' individwi li ma kellhom l-ebda GEP-NETs) u xi wħud ħarsu lejn ir-rata ta' detezzjoni tal-leżjonijiet (kemm kienu tajbin l-iscans biex jidentifikaw it-tumuri).
English: SomaKit TOC can only be obtained with a prescription and the injection must only be prepared and given in a suitable facility by experts in handling radioactive medicines.
Maltese: SomaKit TOC jista' jinkiseb biss b'riċetta ta' tabib u l-injezzjoni għandha tiġi ppreparata u tingħata biss f'faċilità xierqa minn esperti fl-immaniġġjar ta' mediċini radjuattivi.
English: Section 4: Possible side effects
Maltese: Taqsima 4: Effetti sekondarji possibbli
English: Aripiprazole - Aggression and related events (EPITT no
Maltese: Aripiprażolu - Aggressjoni u avvenimenti relatati (EPITT nru
English: Adopted at the 9-12 March 2015 PRAC
Maltese: Adottati fil-PRAC ta' bejn id-9 u t-12 ta' Marzu 2015
English: The PRAC has further agreed that the MAH for Abilify and Abilify Maintena should submit in the next PSUR (data lock point 16/07/2015), a cumulative review of aripiprazole overdose and the risk of aggression and related events.
Maltese: Il-PRAC kompla jaqbel li l-detentur tal-awtorizzazzjoni għat-tqegħid fuq is-suq (MAH) għal Abilify u Abilify Maintena għandu jissottometti fil-PSUR li jmiss (id-data tal-għeluq għad-dejta 16/07/2015), rieżami kumulattiv tad-doża eċċessiva ta' aripiprażolu u r-riskju ta' aggressjoni u avvenimenti relatati.
English: Section 4.8 - Undesirable effects:
Maltese: Taqsima 4.8 - Effetti mhux mixtieqa: