FrancophonIA/ELRC3.0 huggingface dataset:
English: Somatostatin and its analogues are probably competing to bind to the same somatostatin receptors.
Maltese: Somatostatin u l-analogi tiegħu probabilment qed jikkompetu biex jintrabtu mal-istess riċettaturi ta' somatostatin.
English: For radiolabelling with gallium (68Ga) chloride solution.
Maltese: Għal radjutikkettar b'soluzzjoni ta' gallium (68Ga) chloride.
English: 6.3 Shelf life
Maltese: Half-life
English: Administration procedures should be carried out in a way to minimize risk of contamination of the medicinal product and irradiation of the operators.
Maltese: Il-proċeduri ta' għoti għandhom isiru b'mod li inaqqsu kemm jistgħu r-riskju ta' kontaminazzjoni talprodott mediċinali u l-irradjazzjoni tal-operaturi.
English: - if you have others medical conditions, such as high level of cortisol in the body (Cushing syndrome), inflammation, thyroid disease, other type of tumour (of pituitary gland, lung, brain, breast, immune system, thyroid, adrenal gland or others) or disease of spleen that may affect the interpretation of the images; - if you have been taking other medicines, such as somatostatin analogues and glucocorticoids, which may interact with SomaKit TOC; - if you are pregnant or believe you may be pregnant; - If you are breast-feeding.
Maltese: - jekk għandek kondizzjonijiet mediċi oħra, bħal livell għoli ta' kortisol fil-ġisem tiegħek (issindrome ta' Cushing), infjammazzjoni, mard tat-tirode, tip ieħor ta' tumur (ta' glandola pitwitarja, pulmun, moħħ, sider, sistema immuni, tirojdi, glandola adrenali jew oħrajn) jew mard tal-milsa li jista' jaffettwa l-interpretazzjoni tal-immaġini: - jekk kont qed tieħu mediċini oħra, bħal analogi ta' somatostatin u glukokortikojdi, li jistgħu jirreaġixxu ma' SomaKit TOC; - jekk inti tqila jew taħseb li inti tqila; - jekk qed tredda'
English: Finally remove the 0.2 µm sterile vent filter and move the vial to the hole of the dry bath at 95°C, using a plier.
Maltese: Finalment neħħi l-vent filter sterili ta' 0.2 µm u ċaqlaq il-kunjett għal ġot-toqba fid-dry bath f'temperatura ta' 95°C, bi plajer.
English: Radiolabelling of carrier molecules with gallium (68Ga) chloride is very sensitive to the presence of trace metal impurities.
Maltese: Ir-radjutikkettar ta' molekuli trasportaturi b'gallium (68Ga) chloride huwa sensittiv ħafna għallpreżenza ta' impuritajiet ta' metalli f'ammonti ta' traċċa.
English: The organs with high physiological uptake of gallium (68Ga) edotreotide include spleen, kidneys, liver, pituitary gland, thyroid gland and adrenals.
Maltese: L-organi b'teħid fiżjoloġiku għoli ta' gallium (68Ga) edoterotide jinkludu l-milsa, il-kliewi, il-fwied, ilglandola pitwitarja, il-glandola tirojdi u l-adrenali.
English: Reaction buffer
Maltese: Mhux applikabbli
English: The effective dose resulting from the administration of an activity of 200 MBq to an adult weighing 70 kg is about 4.2 mSv.
Maltese: MBq għal adult li jiżen 70 kg hi madwar 4.2 mSv.
English: Reconstitution with GalliaPharm generator: a.
Maltese: Rikostituzzjoni b'ġeneratur GalliaPharm:
English: There is no data if the intravenous administration of edotreotide produces variation of serum gastrin and serum glucagon levels.
Maltese: edotreotide jipproduċix differenza fil-livelli ta' gastrin fis-serum u glukagon fis-serum.
English: - The other ingredients are: 1,10-phenanthroline, gentisic acid, mannitol, formic acid, sodium hydroxide, water for injections.
Maltese: Kunjett wieħed ta' trab fih 40 µg ta' edotreotide - Is-sustanzi l-oħra huma: 1,10-phenanthroline, gentisic acid, mannitol, formic acid, sodium hydroxide, ilma għal injezzjonijiet.
English: After radiolabelling, the solution obtained also contains hydrochloric acid.
Maltese: Wara r-radjutikkettar, is-soluzzjoni miksuba fiha wkoll hydrochloric acid.
English: Excipients:
Maltese: ATC:
English: Although no side effects have been reported, a potential risk of allergic reactions (hypersensitivity) exists with SomaKit TOC.
Maltese: Għalkemm l-ebda effett sekondarju ma ġie rrapportat, jeżisti riskju għal reazzjonijiet allerġiċi (sensittività eċċessiva) b'SomaKit TOC.
English: Quality control Table 2: Specifications of the gallium (68Ga) edotreotide
Maltese: Tabella 2: Speċifikazzjonijiet ta' gallium (68Ga) edotreotide Test
English: 4 hours.
Maltese: 4 sigħat
English: After radiolabelling, store below 25°C.
Maltese: Wara r-radjutikkettar, żomm f'temperatura aktar baxxa minn 25°C.
English: The following authorised generators have shown to be compatible with SomaKit TOC:
Maltese: Il-ġeneraturi awtorizzati li ġejjin ġew murija li huma kompatibbli ma' Somakit TOC:
English: ITLC strip.
Maltese: ITLC.
English: Data supporting efficacy of gallium (68Ga) edotreotide for predicting and monitoring of therapeutic response to peptide receptor radionuclide therapy (PRRT) in histologically confirmed metastatic NET are limited (see section 5.1).
Maltese: Dejta li ssostni l-effikaċja ta' gallium (68Ga) edotreotide biex tipprevedi u tissorvelja r-rispons terapewtiku ta' riċettatur peptide fit-terapija radjunuklide (PRRT - peptide receptor radionuclide therapy) f'NET metaststiku istoloġikament ikkonfermat hija ristretta (ara sessjoni 5.1).
English: Interpretation of gallium (68Ga) edotreotide images and limitations of use PET images with gallium (68Ga) edotreotide reflect the presence of somatostatin receptors in the tissues.
Maltese: Interpretazzjoni tal-immaġini ta' gallium (68Ga) edotreotide u restrizzjonijiet dwar l-użu L-immaġini PET b'gallium (68Ga) edotreotide jirriflettu l-preżenza ta' riċettaturi ta' somatostatin fittessuti.
English: IV after radiolabelling
Maltese: IV wara r-radjutikkettar
English: Lesion-detection rate was 75% (3/4) in the subgroup of patients with unknown primary tumour site of the prospective study of Frilling et al. 2010.
Maltese: Ir-rata ta' leżjonijiet osservati kienet ta' 75% (3/4) fis sottogrupp ta' pazjenti b'sit ta' tumur prinċipali mhux magħruf fl-istudju prospettiv ta' Frilling ed al.
English: Before administration of SomaKit TOC
Maltese: Kif jintuża SomaKit TOC
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION SomaKit TOC 40 micrograms solution for injection Gallium (68Ga) edotreotide
Maltese: SomaKit TOC 40 mikrogramma soluzzjoni għall-injezzjoni Gallium (68Ga) edotreotide
English: In the retrospective paper of Schreiter et al. 2014, the intra-individual comparison in a subgroup of 20 patients showed that gallium (68Ga) edotreotide permitted to localise the primary tumour in 9/20 (45%) patients while indium (111In) pentetreotide did in 2/20 (10%).
Maltese: Fid-dokument retrospettiv ta' Schreiter ed al 2014, it-tqabbil bejn persuna u oħra fis-sottogrupp ta' 20 pazjent wera li gallium (68Ga) edotreotide ppermetta l-lokalizzazzjoni tat-tumur prinċipali f'9/20
English: However, even taking as worst case reference the limits for genotoxic and carcinogenic impurities, the risk related to the trace amounts of 1,10-phenanthroline in SomaKit TOC formulation is considered negligible at the dose to be administered in patients: the exposure to 1,10-phenanthroline (5 µg/dose) is 24 fold lower than the acceptable daily intake for a genotoxic impurity (120 µg/day for exposures <1 month).
Maltese: Madanakollu, anke jekk tittieħed bħala referenza l-agħar każ il-limiti għal impuritajiet ġenotossiċi u karċinoġeniċi, ir riskju relatat mal-ammonti traċċa ta' 1,10-phenanthroline fil-formulazzjoni ta' SomaKit TOC hi kkonsidrata insinjifikanti fid-doża li trid tiġi amministrata: l-esponiment ta' 1,10-phenanthroline (5 µg/doża) hija 24 darba anqas baxxa mit-teħid aċċettat ta' kuljum għal impurità ġenotossika (120 µg/jum għal esponimenti <;1 xahar).
English: Thin layer chromatography (ITLC2, see details below)
Maltese: Kromatografija ta' saff irqieq (ITLC2, ara dettalji hawn isfel)
English: Talk to your nuclear medicine specialist before you are given SomaKit TOC: - if you experience any signs of allergic reaction (listed in section 4) after previous administration of SomaKit TOC; - if you have kidney or liver problems (renal or hepatic disease); - if you are under 18 years of age; - if you have signs of dehydration before and after the examination;
Maltese: Kellem lill-ispeċjalista tal-mediċina nukleari tiegħek qabel ma tingħata SomaKit TOC: - jekk tesperjenza xi sinjal ta' reazzjoni allerġika (elenkata f'sezzjoni 4) wara għoti li ngħata qabel ta' SomaKit TOC: - jekk għandek problemi fil-kliewi jew fil-fwied (mard renali jew epatiku); - Jekk inti għadek m'għalaqtx it-18-il sena; - jekk għandek sinjali ta' diżidrazzjoni qabel u wara l-eżami;
English: A prospective intra-individual comparison showed that gallium (68Ga) edotreotide is able to detect lesions better than indium (111In) pentetreotide.
Maltese: Tqabbil intraindividwali prospettiv wera li gallium (68Ga) edotreotide huwa kapaċi jintraċċa leżjonijiet aħjar minn indium (111In) pentetreotide.
English: Regarding the novel excipient (1,10-phenanthroline), during the toxicity study conducted with the kit formulation of SomaKit TOC including 1,10-phenanthroline at a dose 400 fold higher than the human dose, no toxicity signs were observed.
Maltese: Rigward l-eċċipjent ġdid (1,10-phenanthroline), waqt l-istudju ta' tossiċità li sar bil-formulazzjoni tassett ta' SomaKit TOC li jinkludi 1,10-phenanthroline f'doża 400 darba aktar mid-doża umana, l-ebda sinjali ta' tossiċità ma' ġew osservati.
English: • Glass-fibre ITLC paper (e.g. Agilent ITLC SGI001) pre-cut to 1 cm x 12 cm strips
Maltese: • Karta ITLC ta' fibri-ħġieġ (eż. Agilent ITLC SGI001) mqattgħa fi strixxi minn qabel ta' 1 ċm x 12-il ċm
English: For storage conditions after radiolabelling of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-radjutikkettar tal-prodott mediċinali, ara sezzjoni 6.3.
English: The organ uptake has been shown to be age-independent in normal adult human tissues and also predominantly gender-independent (except for the thyroid and head of pancreas).
Maltese: It-teħid mill-organi ġie muri li hu indipendenti mill-età f'tessuti umani adulti normali u huwa wkoll prevalentament indipendenti mis-sess (ħlief għat-tirojdi u r-ras tal-frixa).
English: d. Scan the ITLC with a radiometric ITLC scanner e. The retention factor (Rf) specifications are as follows: Not complexed gallium (68Ga) = 0 to 0.1 gallium (68Ga) edotreotide = 0.8 to 1
Maltese: Gallium (68Ga) mhux f'kumpless = 0 sa 0.1 gallium (68Ga) edotreotide = 0.8 sa 1
English: In patients with Cushing syndrome, the normalisation of hypercortisolism should be considered before performing PET with SomaKit TOC.
Maltese: F'pazjenti bis-sindrome ta' Cushing, in normalizzazzjoni ta' iperkortisoliżmu għandu jiġi kkonsidrat qabel ma' jsir PET b'SomaKit TOC.
English: Kidneys
Maltese: Pulmun
English: Marketing authorisation holder Advanced Accelerator Applications 20 rue Diesel
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Advanced Accelerator Applications 20 rue Diesel
English: Withdraw the syringe and the 0.2 µm sterile vent filter and move the vial to the hole of the dry bath at 95°C, using a plier.
Maltese: Iġbed is-siringa u l-vent filter sterili ta' 0.2 µm u ċaqlaq il-kunjett għal ġot-toqba fid-dry bath f'temperatura ta' 95°C, bi plajer.
English: Figure 2: Radiolabelling procedure when using Galli Ad generator
Maltese: Figura 2: Proċedura ta' radjutikettar meta jintuża ġeneratur Galli Ad
English: b. Apply a drop of the gallium (68Ga) edotreotide solution on a pencil line 1 cm from the bottom of the ITLC strip.
Maltese: b. Itfa' qatra ta' gallium (68) edotreotide fuq il-linja tal-lapes 1 cm ‘il fuq mill-qiegħ tal istrippa ITLC.
English: • One vial of buffer: 10 ml cyclic olefin polymer vial closed with a teflon stopper and sealed with a flip-off cap. Each vial contains 1 ml of reaction buffer.
Maltese: • Kunjett wieħed ta' baffer: Kunjett ta' 10 ml cyclic olefin polymer magħluq b'tapp tatteflon u ssiġillat b'għatu li jinqala' bis-saba'.
English: d. Scan the ITLC with a radiometric ITLC scanner The retention factor (Rf) specifications are as follows: gallium (68Ga) edotreotide = 0.1 to
Maltese: L-isfeċifikazzjonijiet tal-fattur ta' ritenzjoni (Rf - Retention factor) huma kif ġejjin: gallium (68Ga) edotreotide = 0.1 sa 0.2
English: At the chemical concentrations used for diagnostic examinations, gallium (68Ga) edotreotide does not appear to have any clinically relevant pharmacodynamic effect.
Maltese: Fil-konċentrazzjonijiet kimiċi użati għall-eżamijiet dijanjostiċi, gallium (68Ga) edotreotide ma jidhirx li għandu xi effett farmakodinamiku klinikament rilevanti.
English: In the study of Lee et al. 2015 in 13 GEP-NET patients, a total of 35 positive lesions were detected in 10 patients on either gallium (68Ga) edotreotide PET/CT or indium (111In) pentetreotide
Maltese: Fl-istudju ta' Lee et al 2015 fuq 13-il pazjent b'GEP-NET, total ta' 35 leżjoni pożittiva ġew osservati jew b'gallium (68Ga) edotreotide PET/CT jew indium (111In) pentetreotide SPECT/CT filwaqt li 3 pazjenti ma esebew l-ebda leżjoni pożittiva fl-ebda metodu ta' immaġini.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-websajt tal-Aġenzija Ewropea dwar ilMediċini http://www.ema.europa.eu/
English: Pierce the Vial 1 septum with a 0.2 µm sterile vent filter in order to maintain atmospheric pressure within the vial during the radiolabelling process.
Maltese: Taqqab is-septum ta' Kunjett 1 b'vent filter sterili ta' 0.2 µm sabiex iżżomm il-pressjoni atmosferika fi ħdan il-kunjett waqt il-proċess ta' radjutikkettar.
English: The dosimetry of gallium (68Ga) edotreotide was calculated by Sandstrom et al. (2013), using
Maltese: Id-dożimetrija ta' gallium (68Ga) edotreotide ġiet ikkalkulata minn Sandstrom ed al.
English: The labelling efficiency is calculated by integration of peak with Rf = 0 to 0.1 that must be ≤ 3%.
Maltese: L-effiċjenza ta' tikkettar hi kalkulata b'integrazzjoni tal-ogħla punt b'Rf = 0 sa 0.1 li jrid ikun ≤ 3%.
English: Name and address of the manufacturer responsible for batch release Gipharma S.r.l.
Maltese: Manifattur Gipharma S.r.l.
English: Somatostatin is a neurotransmitter in the central nervous system, but also a hormone which binds to cells of neuroendocrine origin and inhibits the release of growth hormone, insulin, glucagon, and gastrin.
Maltese: Somatostatin huwa newrotrasmettitur fis-sistema nervuża ċentrali, u wkoll ormon li jintrabat ma' ċelluli ta' oriġini newroendokrina u jimpedixxi r-rilaxx talormon tal-iżvilupp, insulina, glukagon u gastrin.
English: Assay the vial radioactivity using a suitable radioactivity calibration system and record the result.
Maltese: Assaġġa r-radjuattività tal-kunjett permezz ta' sistema ta' kalibrazzjoni radjuattiva xierqa u rreġistra r-riżultat.
English: NAME OF THE MEDICINAL PRODUCT SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation edotreotide
Maltese: TAL-PRODOTT MEDIĊINALI SomaKit TOC 40 mikrogramma sett għall-preparazzjoni radjufarmaċewtika edotreotide
English: Visual inspection pH
Maltese: Metodu ħielsa minn frak viżibbli pH
English: The recommended time for imaging is 40 to 90 minutes post injection.
Maltese: Il-ħin rakkomandat għat-teħid ta' immaġini hu minn 40 sa 90 minuta wara l-injezzjoni.
English: With a low dead space 1 ml sterile syringe carefully withdraw 0.5 ml reaction buffer, and keep the reaction buffer in syringe for step “i”.
Maltese: Bi spazju mejjet baxx ta' 1 ml f'siringa sterili, iġbed b'attenzjoni 0.5 ml tal-baffer ta' reazzjoni, u żomm il-baffer ta' reazzjoni fis-siringa għal stadju "i".
English: SomaKit TOC contains sodium
Maltese: SomaKit TOC fih is-sodju
English: One vial of powder contains 40 µg of edotreotide.
Maltese: Kull kunjett fih 40 mikrogramma ta' edotreotide.
English: Set the temperature of the shielded dry bath at 95°C and wait for the temperature to reach the set point and stabilize.
Maltese: Issettja t-temperatura tad-dry bath protett għal 95°C u stenna sakemm it-temperatura tilħaq il-punt issettjat u tistabilizza.
English: In the study of Buchmann et al. 2007, conducted in 27 patients mostly with GEP-NET (59%) or NETs of unknown primary (30%), gallium (68Ga) edotreotide identified 279 lesions versus 157 lesions seen with indium (111In) pentetreotide.
Maltese: (34/40) ġiet osservata fl-istudju ta' Hofmann et al. 2001 li arwolaw pazjenti istoloġikament ipprovati b'NET bronkjali (n=2) jew ta' nofs l-imsaren (n=6). Fl-istudju ta' Buchmann et al. 2007, li sar fuq 27 pazjent il-maġġoranza tagħhom b'GEP-NET (59%) jew NETs prinċipali ta' provenjenza mhux magħrufa (30%), gallium (68Ga) edotreotide identifika 279 leżjoni kontra l-157 leżjoni osservata b'inidium (111In) pentetreotide.
English: With a low dead space 1 ml sterile syringe carefully withdraw 100 µl and keep the reaction buffer in syringe for step “g”.
Maltese: Bi spazju mejjet baxx ta' 1 ml f'siringa sterili, iġbed b'attenzjoni 100 µl tal-baffer ta' reazzjoni, u żomm il-baffer ta' reazzjoni fis-siringa għal stadju "g".
English: Approximately 16% of gallium (68Ga) edotreotide activity is removed from the body in the urine within 2 to 4 hours.
Maltese: Madwar 16% tal-attivita ta' gallium (68Ga) edotreotide titneħħa mill-ġisem mal-urina fi żmien sagħtejn sa 4 sigħat.
English: Leave the vial at 95°C for at least 7 minutes (do not exceed 10 minutes heating) without agitation or stirring.
Maltese: Ħalli l-kunjett f'temperatura ta' 95°C għal tal-anqas 7 minuti (issaħħanx għal aktar minn 10 minuti) mingħajr aġitazzjoni jew taħlit.
English: NAME OF THE MEDICINAL PRODUCT SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation
Maltese: IL-PRODOTT MEDIĊINALI SomaKit TOC 40 mikrogramma sett għall-preparazzjoni radjufarmaċewtika
English: How SomaKit TOC is stored 6.
Maltese: Kif taħżen SomaKit TOC 6.
English: Do not store above 25°C after radiolabelling.
Maltese: M'għandekx taħżen f'temperatura ogħla minn 25°C wara r-radjutikkettar.
English: Paediatric population The safety and efficacy of gallium (68Ga) edotreotide has not been established in paediatric populations, where the effective dose might be different than in adults.
Maltese: Is-sigurtà u l-effikaċja ta' gallum (68Ga) edotreotide ma ġewx stabbiliti f'popolazzjonijiet pedjatriċi, fejn id-doża effettiva tista' tkun differenti milli f'adulti.
English: Perform the quality control according to the recommended methods in order to check the compliance to the specifications (see section, “Quality control”).
Maltese: Wettaq il-kontroll ta' kwalità skont il-metodi rakkomandati sabiex tiġi verifikata lkonformità għall-ispeċifikazzjonijiet (ara sezzjoni, "Kontroll ta' kwalità"). m.
English: Renal impairment / Hepatic impairment The safety and efficacy of gallium (68Ga) edotreotide have not been studied in patients with renal or hepatic impairment.
Maltese: Indeboliment tal-kliewi / Indeboliment tal-fwied Is-sigurtà u l-effikaċja ta' gallum (68Ga) edotreotide ma ġewx studjati f'pazjenti b'indeboliment tal-kliewi jew tal-fwied.
English: Precautions to be taken before handling or administration of the medicinal product For instructions on radiolabelling of the medicinal product before administration, see section 12.
Maltese: Għal istruzzjonijiet dwar ir-radjutikkettar tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 12.
English: Mechanism of action Gallium (68Ga) edotreotide binds to somatostatin receptors.
Maltese: L-attività ta' gallium (68Ga) edotreotide trid titkejjel b'attivimetru eżatt qabel l-injezzjoni.
English: Recommended method for determining labelling efficiency of gallium (68Ga) edotreotide:
Maltese: Metodu rakkomandat li jistabilixxi l-effiċjenza ta' tikkettar għal gallium (68 Ga) edotreotide:
English: Other medicines and SomaKit TOC
Maltese: Kif taħżen SomaKit TOC
English: A schematic representation of the radiolabelling procedure is shown in Figure 2.
Maltese: Rappreżentazzjoni skematika tal-proċedura ta' radjutikkettar murija f'Figura 2.
English: The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection.
Maltese: L-attività rakkomandata għal adult li jiżen 70 kg hi 100 sa 200
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of powder contains 40 micrograms of edotreotide
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kunjett wieħed ta' trab fih 40 mikrogramma ta' edotreotide
English: The retrospective study of Kroiss et al. 2013 in 249 NET patients showed that PRRT does not significantly influence semiquantitative uptake of gallium (68Ga) edotreotide PET, except in liver metastases of patients with NET, but the study lacked histological confirmation.
Maltese: L-istudju retrospettiv ta' Kroiss et al. fl-2013 f'249 pazjent b'NET wera li PRRT ma jaffettwax b'mod sinjifikanti l-influwenza semikwantitattiva ta' gallium (68Ga) edotreotide PET, għajr fil-metastasi tal fwied ta' pazjenti b'NET, imma l-istudju ma kellux konferma istoloġika.
English: b. Apply a drop of the gallium (68Ga) edotreotide on a pencil line 1 cm from the bottom of the
Maltese: b. Itfa' qatra ta' soluzzjoni ta' gallium (68Ga) edotreotide fuq il-linja tal-lapes 1 cm ‘il fuq mill-qiegħ tal-istrippa
English: Breasts
Maltese: Kliewi
English: c. Place the ITLC strip in the developing tank and allow it to develop for a distance of 9 cm from the point of application.
Maltese: Qiegħed l-istrixxa tal-ITLC fit-tank tal-iżvilupp u ħallieha tiżviluppa għal distanza ta' 9 ċm mill-punt t'applikazzjoni.
English: In the study by Gabriel et al. 2009 pre-PRRT gallium (68Ga) edotreotide was compared with CT or MRI using the Response Evaluation Criteria in Solid Tumors (RECIST).
Maltese: Fl-istudju minn Gabriel et al. 2009 gallium (68Ga) edotreotide ta' qabel PRRT kien imqabbel ma' CT jew MRI permezz tal-Kriterja ta'
English: What SomaKit TOC looks like and contents of the pack SomaKit TOC is a kit for radiopharmaceutical preparation containing: - A glass vial with black flip-off cap containing a white powder.
Maltese: Kif jidher SomaKit TOC u l-kontenut tal-pakkett SomaKit TOC huwa sett għall-preparazzjoni radjofarmaċewtika li fih: - Kunjett tal-ħġieġ b'għatu li taqla' bis-saba' li fih trab abjad.
English: Local tolerance assessment resulted in mild to moderate inflammation signs in the perivascular region of some animals which can be attributed to the acidic pH of the solution.
Maltese: Stima fuq tolleranza lokali rriżultat f'sinjali ta' infjammazzjoni minn ħafifa għal moderata fir-reġjun perivaskulari ta' xi annimali li jista' jiġi attribwit għall-pH aċiduż tas-soluzzjoni.
English: In case of Cushing syndrome, a long-term exposure to endogenous hypercortisolism may down regulate somatostatin receptor expression and negatively influence the results of somatostatin receptor imaging with gallium (68Ga) edotreotide.
Maltese: F'każ tas-sindrome ta' Cushing, esponiment fuq terminu ta' żmien twil għal iperkortisoliżmu endoġenu jista' jirregola 'l isfel l-espressjoni ta' riċettaturi ta' somatostatin u jinfluwenza b'mod negattiv ir-riżultati ta' immaġini ta' riċettatur ta' somatostatin b'gallium (68Ga) edotreotide.
English: Gallium (68Ga) edotreotide PET and CT showed a concordant result in 32 patients
Maltese: Gallium (68Ga) edotreotide PET u CT urew riżultat konkordanti fi 32 pazjent (70%) u diskrepanzi f'14
English: An increased uptake of gallium (68Ga) edotreotide is not specific for GEP-NET.
Maltese: Teħid ogħla ta' gallium (68Ga) edotreotide mhux speċifiku għal GEP-NET.
English: After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.
Maltese: edotreotide miksuba hija indikata għal teħid b'immaġini permezz tal-Positron Emission Tomography (PET) ta' espressjoni emfatika ta' riċettaturi ta' somatostatin f'pazjenti adulti b'tumuri newroendokrinali gastroenteropankreatiċi divrenzjati sew ikkonfermati jew suspettati (GEP-NETgastro-enteropancreatic neuroendocrine tumours) għall-alokazzjoni ta' tumuri ewlenien u l-metastasi tagħhom.