FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg apixaban.
Maltese: Kull pillola miksija b'rita fiha 5 mg apixaban.
English: The film coated tablets are pink, oval and marked with “894” on one side and “5” on the other side.
Maltese: Il-pilloli miksijin b'rita huma roża, ovali u mmarkati b'“894” fuq naħa waħda u b'“5” fuq in-naħa loħra.
English: In the study, both doses of apixaban were statistically superior to placebo in the primary endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death (see Table 12).
Maltese: Fl-istudju, iż-żewġ dożi ta' apixaban kienu statistikament superjuri għal plaċebo fil-punt aħħari primarju ta' VTE sintomatika, rikorrenti (DVT mhux fatali jew PE mhux fatali) jew mewt mill-kawżi kollha (ara Tabella 12).
English: In the study, apixaban achieved statistically significant superiority in the primary endpoint of prevention of stroke (haemorrhagic or ischaemic) and systemic embolism (see Table 4) compared with warfarin.
Maltese: Fl-istudju, apixaban kiseb superjorità statistikament sinifikanti fil-punt tat-tmiem primarju talprevenzjoni ta' puplesija (emorraġika jew iskemika) u emboliżmu sistemiku (ara Tabella 3) meta mqabbel ma' warfarin.
English: Apixaban is metabolised mainly via CYP3A4/5 with minor contributions from CYP1A2, 2C8, 2C9, 2C19, and 2J2.
Maltese: Studji ta' apixaban in vitro ma urew ebda effett inibitorju fuq l-attività ta' CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2D6 jew CYP3A4
English: There was no impact of impaired renal function on peak concentration of apixaban.
Maltese: Ma kien hemm ebda impatt ta' funzjoni renali indebolita fuq il-konċentrazzjoni massima ta' apixaban.
English: Stroke or systemic embolism* 51 (1.62) Stroke Ischaemic or unspecified Haemorrhagic Systemic embolism Stroke, systemic embolism,
Maltese: Infart mijokardiku * Fsada maġġuri definita skont il-kriterji tas-Soċjetà Internazzjonali tat-Trombożi u Emostasti (ISTH). †
English: Active substances which are not considered strong inhibitors of both CYP3A4 and P-gp, (eg., diltiazem, naproxen, clarithromycin, amiodarone, verapamil, quinidine) are expected to increase apixaban plasma concentration to a lesser extent.
Maltese: Sustanzi attivi li mhumiex ikkunsidrati inibituri b'saħħithom kemm għal CYP3A4 kif ukoll għal P-gp, (eż., diltiazem, naproxen, clarithromycin, amiodarone, verapamil, quinidine) huma mistennija li jżidu l-konċentrazzjoni ta' apixaban fil-plasma sa ċertu punt.
English: For patients randomised to warfarin, the median percentage of time in therapeutic range (TTR) (INR 2-3) was 66%.
Maltese: Għal pazjenti magħżula b'ordni addoċċ li ngħataw warfarin, il-persentaġġ medjan tal-ħin fil-medda terapewtika (TTR) (INR 2-3) kien 66%.
English: - Changing from Eliquis to anticoagulant medicines Stop taking Eliquis.
Maltese: Tibdil minn Eliquis għal mediċini ta' kontra l-koagulazzjoni Tibqax tieħu Eliquis.
English: In the study, both doses of apixaban were statistically superior to placebo in the primary endpoint of symptomatic, recurrent VTE (nonfatal DVT or nonfatal PE) or all-cause death (see Table 10).
Maltese: Fl-istudju, iż-żewġ dożi ta' apixaban kienu statistikament superjuri għal plaċebo fil-punt aħħari primarju ta' VTE sintomatika, rikorrenti (DVT mhux fatali jew PE mhux fatali) jew mewt mill-kawżi kollha (ara Tabella 10).
English: Do not take Eliquis if: - you are allergic to apixaban or any of the other ingredients of this medicine (listed in section 6) - you are bleeding excessively - you have a disease in an organ of the body that increases the risk of serious bleeding (such as an active or a recent ulcer of your stomach or bowel, recent bleeding in your brain) - you have a liver disease which leads to increased risk of bleeding (hepatic coagulopathy) - you are taking medicines to prevent blood clotting (e.g., warfarin, rivaroxaban, dabigatran or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open, or if a tube is inserted into your blood vessel (catheter ablation) to treat an irregular heartbeat (arrhythmia).
Maltese: Tiħux Eliquis jekk: inti allerġiku/a għal apixaban jew xi sustanzi oħra ta' din il-mediċina (elenkati fis-sezzjoni 6) qed joħroġlok ħafna demm għandek marda f'xi organu tal-ġisem li żżid ir-riskju ta' fsada serja (bħal ulċera attiva jew reċenti fl-istonku jew fl-imsaren tiegħek, fsada reċenti f'moħħok) għandek marda tal-fwied li twassal għal riskju miżjud ta' fsada (koagulupatija epatika) tieħu mediċini li jipprevjenu l-għaqid tad-demm (e.ż. warfarin, rivaroxaban, dabigatran jew heparin), minbarra meta jkun tibdil fit-trattament ta' kontra il-koagulazzjoni, waqt li jkollok linja fil-vini jew fl-arterji jkollok l-eparina għaddejja minn din biex iżżommha miftuħa, jew jekk jiddaħħal tubu fil-vini jew arterji tad-demm tiegħek (ablazzjoni tal-kateter) biex jikkura taħbit tal-qalb irregolari (arritmija).
English: In the study, apixaban was shown to be non-inferior to enoxaparin/warfarin in the combined primary endpoint of adjudicated recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death (see Table 8).
Maltese: Fl-istudju, intwera li apixaban kien mhux inferjuri għal enoxaparin/warfarin fil-punt aħħari primarju kombinat ta' VTE sintomatika rikorrenti aġġudikata (DVT mhux fatali jew PE mhux fatali) jew mewt relatata ma' VTE (ara Tabella 8).
English: In a clinical study in atrial fibrillation patients, diminished efficacy and a higher risk of bleeding were observed with coadministration of apixaban with strong inducers of both CYP3A4 and P-gp compared with using apixaban alone.
Maltese: Fi studju kliniku f'pazjenti b'fibrillazzjoni tal-atriju, kien osservat tnaqqis fl-effikaċja u żieda fir-riskju ta' fsada meta apixaban ingħata fl-istess ħin ma' indutturi b'saħħithom ta' CYP3A4 u P-gp meta mqabbel mal-għoti ta' apixaban waħdu.
English: The known side effects and how frequently they occur for each of these medical conditions may differ and are listed separately below.For these conditions, the most common general side effect of Eliquis is bleeding which may be potentially life threatening and require immediate medical attention.
Maltese: L-effetti sekondarji possibli li huma magħrufa u l-frekwenza tagħhom f'kull waħda minn dawn il-kundizzjonijiet mediċi jistgħu jkunu differenti u huma elenkati hawn taħt separatament.
English: • Patient Alert Cards
Maltese: • Kartuna ta' Twissija Għal Pazjent
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, fertility and embryo-foetal development and juvenile toxicity.
Maltese: Tagħrif ta' qabel l-użu kliniku fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, fertilità u l-iżvilupp embrijo-fetali u tossiċtà ġovanili, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Following administration of a crushed 5 mg apixaban tablet suspended in 60 mL of D5W and delivered via a nasogastric tube, exposure was similar to exposure seen in other clinical trials involving healthy subjects receiving a single oral 5 mg apixaban tablet dose.
Maltese: Wara l-għoti ta' pillola mfarrka ta' 5 mg ta' apixaban sospiża f'60 mL D5W u mogħtija permezz ta' tubu nażogastriku, l-espożizzjoni kienet simili għall-esposizzjoni osservata fi provi kliniċi oħrajn li kienu jinvolvu individwi b'saħħithom li kienu qed jingħataw doża ta' pilllola waħda ta' 5 mg ta' apixaban.
English: Hepatobiliary disorders Liver function test abnormal, asparate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased
Maltese: Disturbi fil-fwied u fil-marrara Test tal-funzjoni tal-fwied mhux normali, żieda flaspartate aminotransferase, żieda fl-alkaline phosphatase tad-demm, żieda fil-livell tal-bilirubina fid-demm
English: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) The recommended dose of apixaban is 5 mg taken orally twice daily.
Maltese: Prevenzjoni ta' puplesija u emboliżmu sistemiku f'pazjenti b'fibrilazzjoni atrijali mhux valvulari (NVAF)
English: Eliquis is not recommended as an alternative to unfractionated heparin in patients with pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy since the safety and efficacy of apixaban have not been established in these clinical situations.
Maltese: Eliquis mhuwiex rakkomandat bħala alternattiva għal eparina mhux frazzjonata f'pazjenti b'emboliżmu pulmonari li huma emodinamikament instabbli jew li jistgħu jirċievu trombolisi jew embolektomija pulmonari billi s-sigurtà u l-effikaċja ta' apixaban ma ġewx stabbiliti f'dawn issitwazzjonijiet kliniċi.
English: • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see section 5.2).
Maltese: Mhuwiex rakkomandat f'pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 5.2).
English: Haemodialysis, started two hours after administration of a single dose of apixaban 5 mg, decreased apixaban AUC by 14% in these ESRD subjects, corresponding to an apixaban dialysis clearance of 18 mL/min.
Maltese: L-emodijaliżi, mibdija sagħtejn wara l-amministrazzjoni ta' doża waħda ta' apixaban 5 mg, naqqset l-AUC ta' apixaban b'14% f'dawn is-suġġetti b'ESRD, li tikkorrispondi għal tneħħija ta' apixaban ta' 18 mL/min bid-dijaliżi.
English: 5 May 2009 EMEA/214378/2009
Maltese: 5 ta' Mejju 2009 EMEA/214378/2009
English: The Decentralised Procedure IE/V/0202/001/DC started on 19 January 2007.
Maltese: Il-Proċedura Diċentralizzata IE/V/0202/001/DC bdiet fid-19 ta' Jannar 2007.
English: Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinoline group of antibiotics.
Maltese: Enrofloxacin huwa sustanza sintetika antimikrobika b'medda wiesgħa, li tappartjeni għall-grupp ta' antibijotiċi fluoroquinoline.
English: On 29 April 2008 Ireland, referred the matter to the EMEA under Article 33 (4) of Directive 2001/82/EC, due to concerns, raised by Germany, that enrofloxacin may present a potential serious risk to the environment (risk to blue-green algae and to terrestrial plants).
Maltese: Fid-29 ta' 2008, l-Irlanda rreferiet il-kwistjoni lill-EMEA skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE, minħabba xi tħassib li tqajjem mill-Ġermanja, li enrofloxacin jista' jippreżenta riskju serju potenzjali lill-ambjent (riskju għall-alka blue ħadra u għall-pjanti tal-art).
English: The applicant, Laboratorios Karizoo S.A., submitted an application for a decentralised procedure for Enro-K 10% Oral Solution, indicated for chickens and turkeys and for oral administration via the drinking water.
Maltese: L-applikant, Laboratorios Karizoo S.A., ippreżentaw applikazzjoni għal proċedura diċentralizzata għal Enro-K 10% Oral Solution, indikat għat-tiġieġ u d-dundjani u għall-amministrazzjoni orali permezz tal-ilma tax-xorb.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was Ireland and the Concerned Member States were Belgium, Czech Republic, Germany and Poland.
Maltese: L-applikazzjoni ġiet preżentata fil-qafas tal-Artikolu 32 tad-Direttiva 2001/82/KE, kif emendat, fejn l-Istat Membru ta' Referenza kien l-Irlanda u l-Istati Membri Konċernati kienu lBelġju, ir-Repubblika Ċeka, il-Ġermanja u l-Polonja.
English: During its 13-15 January 2009 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion concluding that the use of the product as recommended does not constitute a risk for the environment and therefore the points of disagreement raised by Germany should not prevent the granting of a Marketing Authorisation.
Maltese: Waqt il-laqgħa tat-13-15 ta' Jannar 2009, is-CVMP, fid-dawl tad-dejta globali disponibbli u ddiskussjoni xjentifika fi ħdan il-Kumitat, adotta b'kunsens opinjoni li tikkonkludi li l-użu tal-prodot kif inhu rakkomandat ma joħloqx riskju għall-ambjent u għalhekk il-punt li dwarhom ma ntlaħaqx qbil mill-Ġermanja ma għandhomx jipprevjenu l-għoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: • Identification of a potential serious risks to blue-green algae and terrestrial plants arising from the use of Enro-K 10% Oral solution.
Maltese: • L-identifikazzjoni ta' riskji serji potenzjali għall-alka blu ħadra u l-pjanti tal-art li huma kkawżati mill-użu ta' Enro-K 10% Oral Solution.
English: No consideration was given nor conclusion drawn regarding the applicability of the conclusions to other licensed products containing the same active ingredient.
Maltese: Ma ngħatat l-ebda kunsidrazzjoni jew konklużjoni rigward l-applikabilità tal-konklużjonijiet għal prodotti liċenzjati oħra li fihom l-istess sustanza attiva.
English: • Adequacy of the data available in respect to the environmental risk assessment for blue-green algae and terrestrial plants;
Maltese: • Kemm kienet xierqa d-dejta disponibbli rigward il-valutazzjoni tar-riskju ambjentali għallalka blu ħadra u l-pjanti tal-art;
English: Moreover, the in vivo binding of gallium (
Maltese: Madanakollu, ir-rabta in vivo ta' gallium (
English: Free gallium-68 = 0.9 to 1
Maltese: gallium-68 liberu = 0.9 sa 1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1141/001
Maltese: FIS-SUQ EU/1/16/1141/001
English: AT, BE, BG, CZ, FR, HR, HU, IS, LU, LV, LT, MT, NL, RO, SI, SK Advanced Accelerator Applications Tel/Tél/Teл/Sími: + 33 4 50 99 30 70
Maltese: AT, BE, BG, CZ, FR, HR, HU, IS, LU, LV, LT, MT, NL, RO, SI, SK Advanced Accelerator Applications
English: Store in a refrigerator (2°C to 8°C).
Maltese: Aħżen fil-friġġ (2°C sa 8°C).
English: Total body Effective dose mSv/MBq
Maltese: Doża effettiva mSv/MBq
English: Manufacturer Gipharma S. r.l.
Maltese: Gipharma S.r.l.
English: OLINDA/EXM 1.1 software (table 1).
Maltese: (2013), permezz ta' softwer OLINDA/EXM 1.1 (tabella 1).
English: Edotreotide is a somatostatin analogue.
Maltese: Edotreotide huwa analogu ta' somatostatin.
English: Material
Maltese: Materjal
English: • Mobile phase: 77 g/L solution of ammonium acetate in water /Methanol 50:50 V/V
Maltese: • Fażi mobbli: 77 g/L soluzzjoni t'ammonium acetate f'ilma /Methanol 50:50
English: Five studies have been submitted, one of them prospective (Gabriel et al. 2009) and four retrospective studies (Kroiss et al. 2013, Ezziddin et al. 2012, Kratochwil et al. 2015 and Luboldt et al.2010a).
Maltese: Ħames studji ġew sottomessi, wieħed minnhom prospettiv (Gabriel et al.2009) u erba studji retrospettivi (Kroiss et al.2013, Ezziddin et al 2012, Kratochwil et al. 2015 u Luboldt et al. 2010a).
English: Gallium (68Ga) edotreotide detected 35/35 (100%) lesions vs 19/35=54% for indium (111In) pentetreotide SPECT/CT.
Maltese: Gallium (68Ga) edotreotide intraċċa 35/35 (100%) leżjoni kontra 19/35=54% indium (111In) pentetreotide b'SPECT/CT.
English: EXP: ________ Time/Date
Maltese: JIS: ________ Ħin/Data
English: It contains the active substance edotreotide.
Maltese: Fiha s-sustanza attiva edotreotide.
English: Method of preparation
Maltese: Metodu ta' preparazzjoni
English: Gallium-68 decays with a half-life of 68 min to stable zinc-68, 89% through positron emission with a mean energy of 836 keV followed by photonic annihilation radiations of 511 keV (178%), 10% through orbital electron capture (X-ray or Auger emissions), and 3% through 13 gamma transitions from 5 excited levels.
Maltese: Gallium-68 jiddekomponi b'half-life ta' 68 minuta għal żingu-68 stabbli, 89% permezz ta' positron emission b'enerġija medja ta' 836 keV segwita minn radjazzjonijiet ta' anniħilazzjoni fotonika ta' 511 keV (178%), 10% permezz ta' qbid elettroniku orbitali (emissjonijiet X-ray jew ta' Auger), u 3% permezz ta' 13-il transizzjoni gamma minn 5 livelli eċitati.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/12/2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 08/12/2016
English: 13040 Saluggia (VC) Italy
Maltese: Via Crescentino, 13040 Saluggia (VC) L-Italja
English: Calibration time: ________ Time/Date
Maltese: Ħin ta' kalibrazzjoni: ________ Ħin/Data
English: Buffer
Maltese: Baffer
English: • Radiometric ITLC scanner
Maltese: • Scanner ITLC radjometriku
English: ITLC2: Material
Maltese: ITLC2:
English: SomaKit TOC contains sodium (see section 2).
Maltese: SomaKit TOC fih is-sodju (ara sezzjoni 2).
English: What SomaKit TOC contains - The active substance is edotreotide.
Maltese: X'fih SomaKit TOC - Is-sustanza attiva hi edotreotide.
English: Powder: 1,10-phenanthroline, gentisic acid, mannitol (E421) Buffer: formic acid, sodium hydroxide (E524), water for injections See leaflet for further information.
Maltese: Trab: 1,10-phenanthroline, gentisic acid, mannitol (E421) Baffer: formic acid, sodium hydroxide (E524), ilma għal injezzjonijiet
English: 01630 Saint Genis Pouilly France tel: +33 4 50 99 30 70 fax: +33 4 50 99 30 71 e-mail: info@adacap.com
Maltese: +33 4 50 99 30 71 posta elettronika: info@adacap.com
English: Table 1: Dosimetry of gallium (68Ga) edotreotide
Maltese: Tabella 1: Dożimetrija ta' gallium (68Ga) edotreotide
English: Absorbed dose in selected organs mGy/MBq
Maltese: Doża assorbita f'organi magħżula mGy/MBq Organi
English: • GalliaPharm, 0.74 - 1.85 GBq, radionuclide generator (Eckert & Ziegler Radiopharma GmbH),
Maltese: GBq, ġeneratur radjunuklide (Eckert & Ziegler Radiopharma GmbH),
English: This medicine contains 1.5 mmol (or 32.5 mg) sodium per dose.
Maltese: Din il-mediċina fiha 1.5 mmol (jew 32.5 mg) sodju f'kull doża.
English: Distribution After intravenous injection, gallium (68Ga) edotreotide is rapidly cleared from the blood following bi exponential elimination of activity with half-lives of 2.0 ± 0.3 min and 48 ± 7 min respectively.
Maltese: Distribuzzjoni Wara injezzjoni ġol-vina,gallium (68Ga) edotreotide jitneħħa malajr mid-demm wara eliminazzjoni biesponenzjali tal-attivita b'ħalf-lives ta' 2.0 ± 0.3 min u 48 ± 7 min rispettivament.
English: • Glass-fibre ITLC paper (e.g. Agilent ITLC SGI001) pre-cut to 1 cm x 12 cm strips Mobile phase: sodium Citrate 0.1 M (pH 5) in water
Maltese: • Karta ITLC ta' fibra tal-ħġieġ (eż. Agilent ITLC SGI001)imqatta' minn qabel fi strixxi ta' 1 ċm x 12-il ċm Fażi mobbli: sodium citrate 0.1 M (pH 5) f'ilma
English: In GEP-NET, a more intense gallium (68Ga) edotreotide uptake than normal background is a consistent finding.
Maltese: F'GEP-NET, teħid aktar intens ta' gallium (68Ga) edotreotide minn dak normali fl-isfond huwa riżultat konsistenti.
English: For the detection of the primary GEP-NET site in case of rising levels of a relevant biochemical tumour marker or in case of proven NET metastasis, patient-based sensitivity and specificity of gallium (68Ga) edotreotide PET were 100% (4/4) and 89% (8/9), respectively, in the prospective study of Gabriel et al. 2007.
Maltese: Għall-osservazzjoni tas-sit ta' GEP-NET prinċipali f'każ ta' livelli li jogħlew ta' marker bijokemikali rilevanti tat-tumur jew f'każ ippruvat ta' metastasi NET, is-sensittività bażata tal-pazjent u l-ispeċifiċità ta' PET b'gallium (68Ga) edotreotide kienu 100% (4/4) u 89% (8/9), rispettivament flistudju prospettiv ta' Gabriel et al. 2007.
English: As an example, an increase in somatostatin receptor density can also occur in the following pathological conditions: subacute inflammations (areas of lymphocyte concentrations), thyroid diseases (e.g. thyroid autonomy and Hashimoto's disease), tumours of the pituitary gland, neoplasms of the lungs (small-cell carcinoma), meningiomas, mammary carcinomas, lympho-proliferative disease (e.g. Hodgkin's disease and non-Hodgkin lymphomas) and tumours arising from tissue embryologically derived from the neural crest (e.g. paragangliomas, medullary thyroid carcinomas, neuroblastomas, pheochromocytomas).
Maltese: Bħala eżempju, żieda fid-densità tar-riċettaturi ta' somatostatin tista' sseħħ ukoll fil-kondizzjonijiet patoloġiċi li ġejjiin: infjammazzjonijiet sottoakuti (partijiet ta' konċentrazzjonijiet limfatiċi), mard tat-tirojde (eż. awtonomija tat-tirojde u marda ta' Hashimoto), tumuri tal-glandola pitwitarja, neoplażmi tal-pulmun (karċinoma ta' mikroċitoma), meninġjomi, karċinomi mammarji, mard limfo-proliferattiv (eż mard ta' Hodgkin u limfomi mhux ta' Hodgkin), tumuri li feġġew minn tessut embrijoloġikament derivat mill-kresta newrali (eż. paraganglijomi, karċinomi tat-tirojde medullari, newroblastomi, feokromoċitomi).
English: In the study of Kowalski et al. 2003 in 4 patients with GEP-NET, gallium (68Ga) edotreotide showed better patient-based detection rate (100%) than indium (111In) pentetreotide (50%).
Maltese: Fl-istudju ta' Kowalski et al. 2003 f'4 pazjenti b'GEP-NET, gallium (68Ga) edotreotide wera rata aħjar ta' intraċċar abbażi ta' pazjent (100%) milli indium (111In) pentetreotide (50%).
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D Mhux applikabbli
English: After 7 minutes, remove the vial from the dry bath, place it in an appropriately labelled lead shield and let it cool down at room temperature for approximately 10 minutes.
Maltese: Wara 7 minuti, neħħi l-kunjett minn ġod-dry bath, qegħdu f'għant taċ-ċomb tikkettat b'mod xieraq u ħallieh jiksah fit-temperatura tal-kamra għal madwar 10 minuti.
English: Acceptance Criteria Method colloidal gallium-68 species Labelling efficiency % Free gallium-68
Maltese: Effiċjenza ta' tikkettar % gallium-68 Liberu
English: METHOD AND ROUTE(S) OF ADMINISTRATION To be radiolabelled with the reaction buffer and a solution of Gallium-68 (68Ga) in HCl provided by a germanium (68Ge)/gallium (68Ga) generator.
Maltese: Għandu jiġi radjutikkettat mal-baffer ta' reazzjoni u soluzzjoni ta' gallium-68 (68Ga) f'HCl fornut minn ġeneratur ta' germanium (68Ge)/gallium (68Ga).
English: EXP After radiolabelling, use within 4 hours.
Maltese: EXP Wara r-radjutikkettar, uża fi żmien 4 sigħat.
English: • Galli Ad, 0.74 - 1.85 GBq, radionuclide generator (IRE-Elit).
Maltese: • Galli Ad, 0.74 - 1.85
English: Genotoxicity studies on 1,10-phenanthroline available in the literature show negative results in bacterial mutation assay (Ames test), while in a mouse lymphoma assay an indication of possible genotoxicity was obtained at concentrations 750 times higher than the maximum 1,10-phenanthroline blood concentration achievable in patients.
Maltese: Studji dwar il-ġenotossiċità fuq 1,10-phenanthroline disponibbli fil-letteratura juru riżultati negattivi fl-assaġġ ta' mutazzjoni batterika (Test t'Ames) filwaqt li l-assaġġ tal-limfoma tal-ġurdien indikazzjoni ta' ġenotossiċita possibbli kienet miksuba f'konċentrazzjonijiet 750 darba ogħla millkonċentrazzjoni massima ta' 1,10-phenanthroline fid-demm miksuba f'pazjenti.
English: pH-indicator strips
Maltese: strixxi indikaturi tal-pH
English: For an administered activity of 200 MBq the typical radiation dose to the critical organs, which are the urinary bladder wall, the spleen, the kidneys and the adrenals, are about 24, 22, 16 and 15 mGy, respectively.
Maltese: MBq id-doża normali ta' radjazzjoni għall-organi kritiċi, li huma ssuperfiċje tal-bużżieqa awrinarja, il-milsa, il-kliewi u l-adrenali, hija madwar 24, 22, 16 u 15 mGy, rispettivament.
English: Thin layer chromatography (ITLC1, see details below)
Maltese: Kromatografija ta' saff irqieq (ITLC1, ara dettalji hawn isfel)
English: The labelling efficiency is calculated by integration of peak with Rf = 0.9 to 1.0 that must be ≤ 2%.
Maltese: L-effiċjenza ta' tikkettar hi kalkulata b'integrazzjoni tal-ogħla punt b'Rf = 0.9 sa 1.0 li jrid ikun ≤ 2%.
English: In the study of Van Binnebeek et al. 2015 in 53 patients with metastatic GEP-NET [mostly GEP-NET (n=39) or NET of unknown origin (n=6)], the lesion-based detection rate of gallium (68Ga) edotreotide was 99.9% (1098/1099) versus 60% (660/1099) for indium (111In) pentetreotide based on the follow-up scans.
Maltese: metastatiku [il-maġġoranza ta' GEP-NET (n=39) jew NET ta' oriġini mhux magħrufa (n=6)] l-intraċċar abbażi ta' ġrieħi ta' gallium (68Ga) edotreotide kien ta' 99.9% (1098/1099) kontra 60%