FrancophonIA/ELRC3.0 huggingface dataset:
English: Lutathera contains sodium
Maltese: Lutathera fih sodium
English: DoR (months)
Maltese: DoR (xhur)
English: Acetic acid, sodium acetate, gentisic acid, ascorbic acid, pentetic acid, sodium chloride 9 mg/mL injection, sodium hydroxide, water for injections.
Maltese: Acetic acid, sodium acetate, gentisic acid, ascorbic acid, pentetic acid, sodium chloride 9 mg/mL
English: Refractory cytopenia with multilineage dysplasia (Myelodysplastic syndrome)
Maltese: Ċitopenja refrattorja b'displasja multilineari (Sindrome mijelodisplastika)
English: Median months (95%-CI)
Maltese: Xhur medjani (95%-CI)
English: Acetic acid Sodium acetate Gentisic acid Ascorbic acid Pentetic acid Sodium chloride Sodium hydroxide Water for injections
Maltese: Sodium acetate Gentisic acid Ascorbic acid Pentetic acid Sodium chloride Sodium hydroxide Ilma għall-injezzjonijiet
English: Hormonal crises
Maltese: Kriżi ormonali
English: The hazard ratio for Lutathera was 0.18 (95% CI: 0.11 - 0.29), indicating 82% reduction in the risk for a patient to progress or die under Lutathera compared to octreotide LAR.
Maltese: Il-proporzjon ta' periklu għal Lutathera kien 0.18 (CI ta' 95%: 0.11 - 0.29), li jindika tnaqqis ta' 82% fir-riskju għal pazjent biex jagħmel progress jew imut taħt Lutathera mqabbel ma' octreotide LAR.
English: • Or hypoalbuminemia < 30 g/L with a decreased prothrombin ratio < 70%.
Maltese: • jew ipoalbuminemija < 30 g/L bi tnaqqis fil-proporzjon ta' protrombina ta' < 70%.
English: • Liver impairment with either total bilirubinemia > 3 times the upper limit of normal or albuminemia < 30 g/L and prothrombin ratio decreased < 70%;
Maltese: • Indeboliment tal-fwied jew b'bilirubinemija totali ta' > 3 darbiet il-limitu ta' fuq tan-normal jew albuminemija ta' < 30 g/L u tnaqqis fil-proporzjon ta' prothrombin ta' < 70%;
English: With respect to overall survival OS, at the time of interim analysis (24 July 2015), there were 17 deaths in the Lutathera arm and 31 in octreotide LAR 60 mg arm and the hazard ratio was 0.459 in favour of Lutathera, but did not reach the level of significance for interim analysis (HR 99.9915% CI: 0.140, 1.506).
Maltese: 17-il mewta fil-parti tal-istudju b'Lutathera u 31 fil-parti tal-istudju b'octreotide LAR 60 mg u l proporzjon ta' periklu kien 0.459 favur Lutathera, iżda ma laħaqx il-livell ta' sinifikat għall-analiżi interim (HR 99.9915% CI: 0.140, 1.506).
English: The final OS analysis is foreseen after 158 cumulative deaths.
Maltese: L-analiżi finali tal-OS hija prevista wara 158 mewt kumulattivi.
English: − One (1) Long needle (90 - 100 mm)
Maltese: − Labra Twila (90 - 100 mm) waħda (1)
English: • Previous chemotherapy;
Maltese: • Kimoterapija preċedenti;
English: Secondary endpoints included objective response rate (ORR), overall survival (OS), time to tumour progression (TTP), safety and tolerability of the medicinal product and quality of life (QoL).
Maltese: Il-punti tat-tmiem sekondarji kienu jinkludu rata ta' rispons oġġettiv (ORR, objective response rate), sopravivenza totali (OS, overall survival), żmien sal-progressjoni tat-tumur (TTP, tumour progression), is-sigurtà u t-tolerabbiltà tal-prodott mediċinali u l-kwalità tal-ħajja (QoL, quality of life).
English: Due to the bone marrow toxicity of Lutathera, the most expected adverse reactions were related to haematological toxicity: thrombocytopenia (25%), lymphopenia (22.3%), anaemia (13.4%), pancytopenia (10.2%).
Maltese: Minħabba t-tossiċità fil-mudullun tal-għadam tal-Lutathera, ir-reazzjonjiet avversi l-aktar mistennija kienu relatati mat-tossiċità ematoloġika: tromboċitopenja (25%), limfopenja (22.3%), anemija (13.4%), u panċitopenija (10.2%).
English: Advanced Accelerator Applications Ibérica, S.L.U.
Maltese: Advanced Accelerator Applications Polska Sp. z o. o.
English: The pharmacokinetics profile in elderly patients (≥ 75 years) has not been established.
Maltese: Il-profil farmakokinetiku fil-pazjenti anzjani (≥75 sena) ma ġiex stabbilit.
English: Myelodisplastic syndrome and acute leukaemia
Maltese: Sindrome mijelodisplastiku u lewkimja akuta
English: Other very common adverse reactions reported include fatigue (27.7%) and decreased appetite
Maltese: Ir-reazzjonijiet avversi l-oħra komuni ħafna rrapportati jinkludu għeja (27.7%) u tnaqqis fl-aptit
English: Lutathera vial tubing connections procedure (see Figure 2):
Maltese: Proċedura għall-konnessjonijiet tat-tubu tal-kunjett tal-Lutathera (ara Figura 2):
English: • Hypersensitivity to the active substance, to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkati fis-sezzjoni 6.1.
English: For patient preparation, see section 4.4.
Maltese: Għal rakkomandazzjonijiet fil-każ ta' estravażazzjoni, ara sezzjoni 4.4.
English: − Two (2) peripheral intravenous plastic catheters
Maltese: − Żewġ (2) kateters tal-plastik periferali għal ġol-vini
English: See Table 5.
Maltese: Ara Tabella 5.
English: The primary endpoint for the study was progression-free survival (PFS) evaluated by response evaluation criteria in solid tumours (RECIST 1.1), based on independent radiology assessment.
Maltese: Il-punt tat-tmiem primarju għall-istudju kien sopravivenza mingħajr progressjoni (PFS, progression-free survival) evalwata permezz ta' kriterji ta' evalwazzjoni tar-rispons f'tumuri solidi (RECIST 1.1) bbażati fuq valutazzjoni radjuloġika indipendenti.
English: • Blood chemistry monitoring: serum creatinine and glycaemia.
Maltese: • Monitoraġġ tal-kimika tad-demm: kreatinina fis-serum u gliċemija.
English: Dose-modifying toxicity (DMT) criteria
Maltese: (DMT, dose modifying toxicity)
English: Urinary Bladder Wall Uterus**
Maltese: Fil-parti anterjuri talimsaren***
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 26 settembru 2017
English: Late-onset myelodisplastic syndrome (MDS) and acute leukaemia (AL) have been observed after treatment with Lutathera (see section 4.8), occurring approximately 28 months (9 - 41) for MDS and 55 months (32 - 125) for AL after the end of treatment.
Maltese: Sindrome mijelodisplastiku (MDS, myelodisplastic syndrome) u lewkimja akuta (AL, acute leukaemia) li jidhru tard kienu osservati wara l-kura bil-Lutathera (ara sezzjoni 4.8), li jidhru madwar 28 xahar (9 - 41) għall-MDS u 55 xahar (32 - 125) għall-AL wara t-tmiem tal-kura.
English: • Kidney function (creatinine and creatinine clearance)
Maltese: • Funzjoni tal-kliewi (kreatinina u tneħħija ta' kreatinina)
English: The most common adverse reactions in patients receiving Lutathera treatment were nausea and vomiting which occurred at the beginning of the infusion in 58.9% and 45.5% of patients, respectively.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni f'pazjenti li jirċievu l-kura bil-Lutathera kienu nawsja u rimettar li seħħew fil-bidu tal-infużjoni fi 58.9% u 45.5% tal-pazjenti, rispettivament.
English: The median PFS for Lutathera was 28.4 months whereas the one of octreotide LAR was 8.5 months.
Maltese: Il-PFS medjan għal-Lutathera kien 28.4 xhur filwaqt li dak tal-octreotide LAR kien 8.5 xhur.
English: − One bag of sodium chloride 9 mg/mL (0.9%) solution for injection (500 mL)
Maltese: − Borża waħda ta' sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni (500 mL)
English: Amino acid solution
Maltese: Acetic acid
English: Physical disability
Maltese: Diżabilità fiżika
English: Transchelation of lutetium from lutetium (175Lu) oxodotreotide into serum proteins has not been observed.
Maltese: Transchelation ta' lutetium minn lutetium (175Lu) oxodotreotide fil-proteini tas-serum ma kinitx osservata.
English: <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma kkaratterizzati kif ġej: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000) u mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: • Impaired haematological function with either Hb < 4.9 mmol/L (8 g/dL), platelets < 75 G/L
Maltese: • Indeboliment tal-funzjoni ematoloġika bi Hb < 4.9 mmol/L (8 g/dL), plejtlits ta' < 75 G/L (75x103/mm3), jew lewkoċiti ta' < 2 G/L (2,000/mm3) (minbarra limfopenja);
English: This medicine contains 0.14 mmol (3.2 mg) of sodium per mL.
Maltese: Kull mL ta' soluzzjoni fih 0.14 mmol (3.2 mg) ta' sodium.
English: − Two (2) infusion poles
Maltese: − Żewġ (2) arbli tal-infużjoni
English: The average beta energy is approximately 0.13 MeV.
Maltese: L-enerġija beta medja hija madwar 0.13 MeV.
English: Elderly:
Maltese: Lott:
English: OS median was 27.4 months in octreotide LAR arm and was not reached in Lutathera arm. An update conducted about one year after (30 June 2016) showed similar trend with 28 deaths in the Lutathera arm and 43 in octreotide LAR 60 mg arm, an HR of 0.536, and a median OS of 27.4 months in octreotide LAR arm and still not reached in Lutathera arm.
Maltese: Twettaq aġġornament madwar sena wara (30 ta' Ġunju 2016) li wera xejra simili bi 28 mewt fil-parti tal-istudju b'Lutathera u 43 fil-parti tal-istudju b'octreotide LAR 60 mg, HR ta' 0.536, u OS medjana ta' 27.4 xhur fil-parti tal-istudju b'octreotide LAR u xorta ma ntlaħqitx fil-parti tal-istudju b'Lutathera.
English: The ORR (including complete response (CR) and partial response (PR) according to RECIST criteria) and duration of response (DoR) for the FAS Dutch population with gastroenteropancreatic (GEP) and bronchial NETs (360 patients) as well as per tumour type are presented in Table 10.
Maltese: L-ORR (inkluż rispons sħiħ (CR, complete response) u rispons parzjali (PR, partial response) skont ilkriterji ta' RECIST) u kemm dam ir-rispons (DoR, duration of response) għall-popolazzjoni Olandiża FAS b'NETs gastroenetropankreatiċi (GEP, gastroenteropancreatic) u tal-bronki (360 pazjent) kif ukoll għal kull tip ta' tumur huma ppreżentati f'Tabella 10.
English: • Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6).
Maltese: • Tqala kkonfermata jew suspettata jew meta t-tqala ma ġietx eskluża (ara sezzjoni 4.6).
English: After administration of Lutathera
Maltese: Kif taħżen Lutathera
English: Lutathera with sodium chloride 9 mg/mL (0.9%) solution for injection
Maltese: Sodium chloride 9 mg/mL (0.9%) soluzzjoni għall injezzjoni
English: Talk to your nuclear medicine doctor if you are under 18 years old.
Maltese: Kellem lit-tabib tal-mediċina nukleari tiegħek jekk għandek inqas minn 18-il sena.
English: PFS Time (months)
Maltese: PFS Żmien (xhur)
English: The mean age of patients enrolled in the study was 58.4 years.
Maltese: L-età medja tal-pazjenti rreġistrati fl-istudju kienet ta' 58.4 sena.
English: Given the fixed volumetric activity of 370 MBq/mL at the date and time of calibration, the volume of the solution is adjusted between 20.5 mL and 25.0 mL in order to provide the required amount of radioactivity at the date and time of infusion.
Maltese: Minħabba l-attività volumetrika fissa ta' 370 MBq/mL fid-data u l-ħin tal-kalibrazzjoni, il volum tas-soluzzjoni huwa aġġustat bejn 20.5 mL u 25.
English: • Mild to moderate chronic kidney disease with creatinine clearance ≥ 50 mL/min;
Maltese: • Mard tal-kliewi kroniku minn ħafif għal moderat bi tneħħija tal-kreatinina ta' ≥ 50 mL/min;
English: There is evidence , from the analysis of urine samples of 20 patients included in the NETTER-1 phase III Dosimetry, pharmacokinetic and ECG substudy, that lutetium (177Lu) oxodotreotide is poorly metabolized and is excreted mainly as intact compound by renal route.
Maltese: Hemm evidenza, mill-analiżi tal-kampjuni tal-awrina ta' 20 pazjent inklużi fis-sottostudju tal-fażi III NETTER-1 dożimetriku, farmakokinetiku u bl-ECG, li lutetium (177Lu) oxodotreotide ma jiġix metabolizzat sew u jiġi eliminat l-aktar bħala kompost intatt mill-mogħdija tal-kliewi.
English: At the concentration used (about 10 μg/mL in total, for both free and radiolabeled forms), the peptide oxodotreotide does not exert any clinically relevant pharmacodynamic effect.
Maltese: Fil-konċentrazzjoni użata (madwar 10 μg/mL bħala total, għall-forom ħielsa u radjutikkettati), l oxodotreotide tal-peptidi ma jeżerċitax kwalunkwe effett farmakodinamiku klinikament sinifikanti.
English: Anaemia4
Maltese: ANNESS III
English: The main analysis has been conducted on 811 Dutch patients with different somatostatin receptor positive tumour types.
Maltese: L-analiżi ewlenija twettqet fuq 811-il pazjent Olandiż b'tipi differenti ta' tumuri pożittivi għar-riċetturi tas-somatostatins.
English: • Severe heart failure defined as class III or IV in the NYHA classifications;
Maltese: • Insuffiċjenza severa tal-qalb definita bħala tal-klassi III jew IV fil-klassifiki tal-NYHA;
English: Please see Table 5 in case of dose modifying toxicity.
Maltese: Jekk jogħġbok ara Tabella 5 fil-każ ta' tossiċità li timmodifika ddoża.
English: No statistically significant difference in PFS was observed between the subgroup of patients who did not receive octreotide LAR (25.4 months [95% CI 22.8-30.6]) versus the subgroup who did receive concomitant treatment with octreotide LAR (30.9 months [95% CI 25.6-34.8]) (p= 0.747).
Maltese: L-ebda differenza statistikament sinifikanti fil-PFS ma kienet osservata bejn is-sottogrupp tal-pazjenti li ma rċevewx ocreotide LAR (25.4 xhur [95% CI 22.8-30.6]) kontra s-sottogrupp li rċieva kura fl-istess ħin b'octreotide LAR (30.
English: • Hematologic monitoring: white blood cells, platelets, and haemoglobin
Maltese: • Monitoraġġ ematoloġiku: ċelloli tad-demm bojod, plejtlits, u emoglobina
English: • Kidney failure with creatinine clearance < 50 mL/min;
Maltese: • Insuffiċjenza tal-kliewi bi tneħħija tal-kreatinina ta' < 50 mL/min;
English: Pancreas
Maltese: Pankreatiku
English: • Previous oncologic radiometabolic therapies with 131I-compounds or any other therapy using unshielded radioactive sources;
Maltese: • Terapiji radjumetaboliċi onkoloġiċi preċedenti b'komposti 131I- jew kwalunkwe terapija oħra li tuża sorsi radjuattivi mingħajr protezzjoni;
English: PFS and OS observed in the Erasmus phase I/II study in Dutch patients with GEP and bronchial NET - (FAS, N=360)
Maltese: PFS u OS osservati fl-istudju tal-fażi I/II Erasmus f'pazjenti Olandiżi b'NETS tal
English: 11 Includes injection site reaction, injection site hypersensibility, injection site induration, injection site swelling * Gamma-glutamyltransferase increased **Alanine amino transferase *** Aspartate amino transferase **** Alkaline phosphatase
Maltese: * Żieda fil-gamma-glutamyltransferase **Alanine amino transferase *** Aspartate amino transferase **** Alkaline phosphatase
English: Low white blood cell count (leukopenia or neutropenia), muscle pain, temporal partial hair loss (alopecia), abdominal distension (feeling bloated), diarrhoea, dizziness, injection site reaction or swelling, disturbed taste, pain in the site of injection, headache, high or low blood pressure, peripheral oedema, abnormal results of renal blood test (increased creatinine), abdominal pain (general and upper), constipation, abnormal results of liver blood test, flushing and hot flushes, increased sugar level in the blood, fainting, renal failure (including acute injury), dehydration, heartburn (dyspepsia), blood in urine, abnormal results of urine test (presence of serum proteins), decrease in function of thyroid, shortness of breath, inflammation of stomach (gastritis), abnormally high amounts of bile pigment (bilirubin) in the blood (Hyperbilirubinemia), abnormal results of blood test (Hypomagnesaemia and hyponatraemia), influenza like illness, chills, bone marrow cancer (myelodysplastic syndrome), blood transfusion.
Maltese: Għadd baxx ta' ċelluli bojod tad-demm (lewkopenja jew newtropenja), uġigħ fil-muskoli, telf parzjali tax-xagħar (alopeċja), distensjoni tal-addome (tħossok minfuħ), dijarea, sturdament, reazzjoni jew nefħa fis-sit tal-injezzjoni, problemi biex ittiegħem sew, uġigħ fis-sit tal-injezzjoni, uġigħ ta' ras, pressjoni tad-demm għolja jew baxxa, edema periferali, riżultati mhux normali tat-test tad-demm talkliewi (żieda fil-kreatinina), uġigħ fl-addome (ġenerali u fil-parti ta' fuq), stitikezza, riżultati mhux normali tat-test tad-demm tal-fwied, ħmura fil-wiċċ u fwawar tas-sħana, żieda fil-livell taz-zokkor fid demm, iħossok ħażin, insuffiċjenza tal-kliewi (inkluż korriment akut), deidratazzjoni, ħruq fl-istonku (dispepsja), demm fl-awrina, riżultati mhux normali tat-test tal-awrina (preżenza ta' proteini fis-seru), tnaqqis fil-funzjoni tat-tirojdi, qtugħ ta' nifs, infjammazzjoni tal-istonku (gastrite), ammonti għoljin b'mod mhux normali tal-pigment tal-bila (bilirubina) fid-demm (iperbilirubinemija), riżultati mhux normali tat-test tad-demm (ipomanjeżemija u iponatremija), mard jixbah l-influwenza, tertir bil-bard, kanċer tal-mudullun (sindrome mijelodisplastika), trasfużjoni tad-demm.
English: The use of Lutathera is contraindicated in patients with severe kidney failure (see section 4.3).
Maltese: Lutathera huwa kontraindikat f'pazjenti b'insuffiċjenza severa tal-kliewi (ara sezzjoni 4.3).
English: Gastrointestinal pain Stomatitis
Maltese: Uġigħ gastro-intestinali
English: In spite of an observed significant selective B-cell depletion, no increase in the rate of infectious complications occurs after PRRT.
Maltese: Minkejja tnaqqis sinifikanti osservat fiċ-ċelloli B selettiv, ma sseħħ l-ebda żieda fir rata ta' komplikazzjonjiet infettivi wara PRRT.
English: It binds to malignant cells which overexpress sst2 receptors.
Maltese: (sst2, subtype 2 somatostatin receptors).
English: Volume: {Y} mL
Maltese: {Y} mL
English: Secondary malignant neoplasms
Maltese: Anemija nefroġenika
English: - The other ingredients are: acetic acid, sodium acetate, gentisic acid, ascorbic acid, diethylene triamine pentaacetic acid (DTPA), sodium chloride 9 mg/mL (0.9%) solution for injection, water for injections (see section 2 “Lutathera contains sodium”).
Maltese: diethylene triamine pentaacetic acid (DTPA), sodium chloride 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni, ilma għall-injezzjonijiet (ara sezzjoni 2 “Lutathera fih sodium”).
English: Factors such as age >70 years, impaired renal function, baseline cytopenias, prior number of therapies, prior exposure to chemotherapeutic agents (specifically alkylating agents), and prior radiotherapy are suggested as potential risks and/or predictive factors for MDS/AL.
Maltese: ċitopenji fil-linja bażi, in-numru ta' terapiji preċedenti, l-esponiment preċedenti għal aġenti kimoterapewtiċi (speċifikament aġenti alkalitiċi), u radjuterapija preċedenti huma ssuġġeriti bħala riskji potenzjali u/jew fatturi ta' tbassir għal MDS/AL.
English: Organ uptake At 4 hours after administration, the distribution pattern of lutetium (177Lu) oxodotreotide shows a rapid uptake in kidneys, tumour lesions, liver and spleen, and in some patients in the pituitary gland and in the thyroid.
Maltese: 4 sigħat wara l-assorbiment, ix-xejra tad-distribuzzjoni ta' lutetium (177Lu) oxodotreotide turi assorbiment rapidu fil-kliewi, fil-leżjonijiet tat-tumur, fil-fwied u fil-milsa, u f'ċertu pazjent fil glandola pitwitarja u fit-tirojdi.
English: These finding are supported by in vitro metabolism data in human hepatocytes, in which no metabolic degradation of lutetium (175Lu) oxodotreotide was observed.
Maltese: Dawn is-sejbiet huma appoġġjati minn dejta dwar il-metaboliżmu in vitro fl-epatoċiti umani, li fihom ma kienet osservata l-ebda degradazzjoni metabolika ta' lutetium (175Lu) oxodotreotide.
English: Osmolarity
Maltese: Osmolarità
English: Hyperbilirubinaemia9
Maltese: Limfopenja3 Anemija4
English: Health Related Quality of Life (HRQOL) was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (generic instrument) and its neuroendocrine tumour module (EORTC QLQ-GI.NET-21).
Maltese: Il-Kwalità tal-Ħajja Relatata mas-Saħħa (HRQOL, Health Related Quality of Life) kienet evalwata bl użu tal-Kwestjonarju dwar il-Kwalità tal-Ħajja tal-Organizzazzjoni Ewropea għar-Riċerka u l-Kura tal-Kanċer (EORTC QLQ-C30) (strument ġeneriku) u l-modulu dwar it-tumuri newroendokrinali tiegħu (EORTC QLQ-GI.NET-21).
English: NETTER-1 phase III study was a multicentre stratified, open labelled, randomized, comparator-controlled, parallel-group study comparing treatment with Lutathera (4 doses of 7,400 MBq every 8 weeks) co-administered with amino acid solution plus best supportive care (BSC; octreotide long acting release [LAR] 30 mg every 4 weeks for symptoms control, replaced by short acting octreotide in the 4 weeks interval before Lutathera administration) to high dose octreotide LAR (60 mg every 4 weeks) in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumours.
Maltese: MBq kull 8 ġimgħat) mogħtija fl-istess ħin ma' soluzzjoni tal-aċidi amminiċi flimkien mal-aħjar kura ta' appoġġ (BSC, best supportive care; octreotride b'rilaxx li jaġixxi fit-tul (LAR, long acting release) 30 mg kull 4 ġimgħat għall-kontroll tas-sintomi, sostitwit b'octreotide b'rilaxx li jaġixxi fi żmien qasir fl-intervall ta' 4 ġimgħat qabel ma jingħata l-Lutathera) ma' doża għolja ta' octreotide LAR (60 mg kull 4 ġimgħat) f'pazjenti li għandhom tumuri karċinojdi fil-parti tan-nofs tal-imsaren, pożittivi għar riċetturi tas-somatostatins, progressivi u inoperabbli.
English: • Previous external beam radiotherapy involving more than 25% of the bone marrow;
Maltese: • Radjuterapija bir-raġġi esterni preċedenti li tinvolvi iżjed minn 25% tal-mudullun;
English: Compound
Maltese: Sinkope
English: − A pair of tongs (for Lutathera vial handling)
Maltese: − Par pinzetti (biex timmaniġġja l-kunjett tal-Lutathera)
English: • History of other malignant tumours unless the patient is considered to be in remission for at least 5 years.
Maltese: • Storja ta' tumuri oħrajn malinni sakemm il-pazjent ma jitqiesx li huwa f'remissjoni għal mill inqas 5 snin.
English: Renal toxicity defined as an estimated creatinine clearance < 40 mL/min, or a 40% increase compare to the baseline serum creatinine level with a decrease of over 40% compared to the baseline creatinine clearance.
Maltese: Tossiċità fil-kliewi definita bħala tneħħija tal kreatinina stmata ta' < 40 mL/min, jew żieda ta' 40% mqabbla mal-livell tal-kreatinina fis-seru fil-linja bażi bi tnaqqis ta' iżjed minn 40%
English: Composition of the standard amino acid solution
Maltese: Kompożizzjoni tas-soluzzjoni standard ta' aċidi amminiċi
English: PFS Kaplan Meier curves of patients with progressive midgut carcinoid tumour - cutoff date 24 July 2015 (NETTER-1 phase III study; FAS, N=229)
Maltese: Figura 3. Il-kurvi ta' Kaplan Meier tal-PFS ta' pazjenti b'tumur karċinojdi progressiv fil-parti tan-nofs tal-imsaren - data tal-għeluq 24 ta' Lulju 2015 (studju tal-fażi III NETTER-; FAS, N=229)
English: The pharmacokinetic profile of lutetium (177Lu) oxodotreotide in patients with severe renal impairment (creatinine clearance < 30 mL/min) has not been studied, therefore treatment with Lutathera in those patients is contraindicated (see section 4.3).
Maltese: Il-profil farmakokinetiku ta' lutetium (177Lu) oxodotreotide f'pazjenti b'indeboliment sever tal-kliewi (tneħħija tal-kreatinina ta' < 30 mL/min) ma ġiex studjat, għaldaqstant il-kura bil-Lutathera f'dawk il-pazjenti hija kontroindikata (ara sezzjoni 4.3).
English: Volumetric activity at calibration time: 370 MBq/mL - {DD/MM/YYYY hh:mm UTC} Activity at infusion time: {Z} MBq - {DD/MM/YYYY hh:mm UTC}
Maltese: 370 MBq/mL - {JJ/XX/SSSS hh:mm UTC} Attività fil-ħin tal-infużjoni: {Z}
English: 370 MBq lutetium (177Lu) oxodotreotide at the date and time of calibration.
Maltese: 370 MBq ta' lutetium (177Lu) oxodotreotide fid-data u l-ħin tal-kalibrazzjoni.