FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal protection and renal impairment Because lutetium (177Lu) oxodotreotide is almost exclusively eliminated through the renal system, it is mandatory to concomitantly administer an amino acid solution containing the amino acids L-lysine and L-arginine.
Maltese: Minħabba li lutetium (177Lu) oxodotreotide huwa kważi esklussivament eliminat permezz tas-sistema tal-kliewi, huwa obbligatorju li tingħata fl-istess ħin soluzzjoni ta' aċidi amminiċi li fiha l-aċidi amminiċi L-lysine u L-arginine.
English: Hepatobiliary disorders
Maltese: Aċidożi metabolika
English: At the time of final per-protocol PFS statistical analysis (cut-off date 24 July 2015), the number of centrally confirmed disease progressions or deaths was 21 events in the Lutathera arm and 70 events in the octreotide LAR arm (Table 8).
Maltese: Fiż-żmien tal-analiżi statistika finali għal kull protokoll PFS (final per-protocol PFS) (data tal-għeluq 24 ta' Lulju 2015), l-għadd ta' progressjonijiet tal-marda u mwiet konfermati ċentralment kienu 21 każ fil-parti tal-istudju b'Lutathera u 70 każ fil-parti tal-istudju b'octreotide LAR(Tabella 8).
English: − Calibrated radioactivity measurement system and Geiger counter to monitor the radioactivity of Lutathera
Maltese: − Sistema tal-kejl tar-radjuattività kalibrata u Geiger counter biex timmonitorja r-radjuattività tal-Lutathera
English: This includes any possible side effects not listed in this leaflet.
Maltese: Dan iseħħ f'ħafna pazjenti u ħafna drabi huwa temporanju.
English: This medicinal product must not be injected as a bolus.
Maltese: Dan il-prodott mediċinali ma għandux jiġi injettat bħala bolus.
English: • Kidney failure with creatinine clearance < 30 mL/min
Maltese: • Insuffiċjenza tal-kliewi bi tneħħija tal-kreatinina ta' < 30 mL/min 4.4
English: Ionizing radiations of lutetium (177Lu) oxodotreotide may potentially have temporary toxic effects on female and male gonads.
Maltese: oxodotreotide jista' jkollhom effetti tossiċi temporanji fuq il-gonads femminili u maskili.
English: PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 30 June 2016 (full analyses set (FAS), N=231)
Maltese: PFS osservat fl-istudju tal-fażi III NETTER-1 f'pazjenti b'tumur karċinojdu progressiv fil-parti tan-nofs tal-imsaren - data tal-għeluq 30 ta' Ġunju 2016 (sett ta' analiżi sħiħa (FAS), N=231)
English: The medicine infusion takes 20 to 30 minutes; but the complete administration procedure will take approximately 5 hours.
Maltese: L-infużjoni tal-mediċina tieħu 20 sa 30 minuta; iżda l-proċedura sħiħa tal-għoti tieħu madwar 5 sigħat.
English: Vasodilatation Peripheral coldness Pallor
Maltese: Vasodilatazzjoni Bard fl-estremitajiet Pallidità
English: Etiology of this therapy related secondary myeloid neoplasms (t-MNs) is unclear.
Maltese: L-etjoloġija ta' dawn in-neoplażmi tal-myeloid sekondarji relatati mat-terapija (t-MNs, therapy related secondary myeloid neoplasms) mhix ċara.
English: Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.
Maltese: Lutathera huwa indikat għall-kura ta' tumuri newroendokrinali gastroenteropankreatiċi (GEP-NETs) pożittivi għar-riċetturi tas-somatostatini, differenzjati sew (G1 u G2), progressivi, li ma jistgħux jitneħħew jew metastatiċi f'adulti.
English: Volumetric activity at calibration time: 370 MBq/mL - {DD/MM/YYYY hh:mm UTC}
Maltese: 370 MBq/mL - {JJ/XX/SSSS hh:mm UTC}
English: There is some evidence that corticosteroids can induce down-regulation of SST2 receptors.
Maltese: Hemm xi evidenza li l-kortikosterojdi jistgħu jinduċu regolazzjoni mnaqqsa tar-riċetturi tal-SST2.
English: CR = Complete response; PR = Partial response; SD = Stable disease; ORR = Objective response (CR+PR); DoR = Duration of response * Includes Foregut, Midgut and Hindgut; **Foregut NETs other than bronchial and pancreatic
Maltese: ORR = Rispons oġġettiv (CR+PR); DoR = Durata tar-rispons
English: Posology
Maltese: Rekwiżiti
English: PFS Kaplan Meier curves of patients with progressive midgut carcinoid tumourcut-off date 30 June 2016 (NETTER-1 phase III study; FAS, N=231)
Maltese: Il-kurvi PFS ta' Kaplan Meier ta' pazjenti b'tumur karċinojdi progressiv fil-parti tannofs tal-imsaren - data tal-għeluq 30 ta' Ġunju 2016 (studju ta' fażi III NETTER-1; FAS,
English: Two hundred thirty-one (231) patients have been randomized to receive either Lutathera (n=117) or octreotide LAR (n=114).
Maltese: jew octreotide LAR (n=114).
English: All*
Maltese: {X}
English: Thrombocytopenia2 Lymphopenia3
Maltese: Reazzjoni fis-sit talinjezzjoni11
English: Thymus
Maltese: Ammont
English: Abdominal pain lower Haematemesis Haemorrhagic ascites Ileus
Maltese: Sabiex tiżgura l-għoti sħiħ, il-kunjett tal-Lutathera għandu jinżamm taħt pressjoni ugwali.
English: • Hematologic toxicity greater or equal to grade 2 (CTCAE) before treatment other than lymphopenia;
Maltese: • Tossiċità ematoloġika ikbar jew ugwali għall-grad 2 (CTCAE) qabel il-kura minbarra limfopenja;
English: Electrocardiogram QT prolonged
Maltese: Titwil tal-QT talelettrokardjogramma
English: Bone marrow toxicity (myelo-/hematotoxicity) manifested with reversible / transient reductions in blood counts affecting all lineages (cytopenias in all combinations, i.e., pancytopenia, bicytopenias, isolated monocytopenias - anemia, neutropenia, lymphocytopenia, and thrombocytopenia).
Maltese: Tossiċità fil-mudullun (mijelo-/ematotossiċità) li tidher ma' tnaqqis riversibbli / temporanju fl-għadd taċ-ċelloli tad-demm li jaffettwa l-linji tan-nisel kollha (ċitopeniji fil-kombinazzjonijiet kollha, jiġifieri panċitopenja, biċitopeniji, monoċitopeniji iżolati - anemija, newtropenja, limfoċitopenja, u tromboċitopenja).
English: It is absolutely necessary to use toilet paper each time.
Maltese: Huwa assolutament neċessarju li tuża t-toilet paper kull darba.
English: The PFS Kaplan-Meier graph for the full analysis set (FAS) at the cut-off date 30 June 2016 is depicted in Figure 4.
Maltese: Il-graff PFS ta' Kaplan-Meier għas-sett tal-analiżi sħiħa (FAS) fid-data tal-għeluq 30 ta' Ġunju 2016
English: Start time (min)
Maltese: Ħin tal bidu (min)
English: STATEMENT OF ACTIVE SUBSTANCE(S) One mL contains 370 MBq of lutetium (177Lu) oxodotreotide at calibration time.
Maltese: ATTIVA(I) mL wieħed fih 370 MBq ta' lutetium (177Lu) oxodotreotide fil-ħin tal-kalibrazzjoni.
English: Urinary incontinence Glomerular filtration rate decreased Renal disorder
Maltese: Inkontinenza tal-awrina Tnaqqis fir-rata tal-filtrazzjoni glomerulari
English: This should be taken into consideration in patient on controlled sodium diet.
Maltese: Dan għandu jingħata kunsiderazzjoni f'pazjenti li għandhom dieta bis-sodium kontrollat.
English: (not < 320 mL/h for commercial solutions)
Maltese: (mhux < 320 mL/siegħa għal soluzzjonijiet kummerċjali)
English: There is no relevant use of Lutathera in the paediatric population in the indication of treatment of GEP-NETs (excluding neuroblastoma, neuroganglioblastoma, phaeochromocytoma).
Maltese: M'hemm l-ebda użu rilevanti ta' Lutathera fil-popolazzjoni pedjatrika għal indikazzjoni tal-kura ta' GEP-NETs (minbarra newroblastoma, newroganglijoblastoma, feokromoċitoma).
English: One mL of solution contains 370 MBq of lutetium (177Lu) oxodotreotide at the date and time of calibration.
Maltese: 1 mL wieħed ta' soluzzjoni fih 370 MBq ta' lutetium (177Lu) oxodotreotide fid-data u l-ħin tal kalibrazzjoni.
English: Hindgut
Maltese: Ansjetà
English: An individual benefit-risk assessment is recommended prior to treatment with Lutathera in patients with mild and moderate renal impairment, for additional details see section 4.2 (Table 3) and section 4.4.
Maltese: Valutazzjoni tal-benefiċċji u r-riskji għallindividwu hija rakkomandata qabel il-kura bil-Lutathera f'pazjenti b'indeboliment tal-kliewi minn ħafif għal moderat, għal dettalji addizzjonali ara sezzjoni 4.2 (Tabella 3) u sezzjoni 4.4.
English: Malaise
Maltese: Stomatite
English: Lysine content
Maltese: Kontenut ta' lysine
English: The recommended infusion method for administration of Lutathera is the gravity method.
Maltese: Il-metodu ta' infużjoni rakkomandat għall-għoti tal-Lutathera huwa l-metodu tal-gravità.
English: Total Body *n=11 (male patients only) **n=9 (female patients only)
Maltese: full analyses set), N=229)
English: Formication
Maltese: Formikazzjoni
English: Pregnancy No studies on animal reproductive function have been conducted with lutetium (177Lu) oxodotreotide.
Maltese: Tqala Ma twettaq l-ebda studju dwar il-funzjoni riproduttiva fl-annimali b'lutetium (177Lu) oxodotreotide.
English: Temporarily discontinue the treatment.
Maltese: Waqqaf il-kura temporanjament.
English: Not reached p-value of Log-rank test Hazard ratio (95%-CI)
Maltese: Mhux milħuq valur p tat-test ta' Log-rank Proporzjon ta' periklu (CI ta' 95%-)
English: PFS differed significantly (p<0.0001) between the treatment groups.
Maltese: Il-PFS kien differenti b'mod sinifikanti (p<0.
English: Pancreatitis acute Rectal haemorrhage Melaena
Maltese: Lewkimja mijelojdi akuta Lewkimja akuta
English: Lethargy Syncope
Maltese: TAĊ-ĊOMB
English: 72 hours from the date and time of calibration.
Maltese: 72 siegħa mid-data u l-ħin tal-kalibrazzjoni.
English: EXPIRY DATE EXP: {DD MM YYYY hh:mm UTC}
Maltese: MBq - {JJ/XX/SSSS hh:mm UTC}
English: Pancytopenia
Maltese: Ipogliċemija
English: The recommended treatment regimen of Lutathera in adults consists of 4 infusions of 7,400 MBq each.
Maltese: Il-kors tal-kura rakkomandat tal-Lutathera fl-adulti jikkonsisti minn 4 infużjonijiet ta' 7,400
English: The recommended interval between each administration is 8 weeks which could be extended up to 16 weeks in case of dose modifying toxicity (DMT) (see Table 5).
Maltese: L-intervall rakkomandat bejn kull għoti huwa ta' 8 ġimgħat li jista' jiġi estiż għal sa 16-il ġimgħa fil-każ ta' tossiċità li timmodifika d-doża (DMT, dose modifying toxicity) (ara Tabella 5).
English: It is necessary to use protective high quality (latex/nitrile) gloves to avoid direct contact with the radiopharmaceutical (vial/syringe).
Maltese: Huwa neċessarju li jintużaw ingwanti protettivi (tal-latex/nitrile) ta' kwalità għolja biex jiġi evitat kuntatt dirett mar-radjufarmaċewtiku (kunjett/siringa).
English: < 1,050 mOsmol
Maltese: V10XX04
English: Tabulated list of adverse reactions The adverse reactions are listed in Table 7 according to the frequency and the MedDRA System Organ
Maltese: Ir-reazzjonijiet avversi huma elenkati f'Tabella 7 skont il-frekwenza u s-Sistema ta' Klassifika talOrgani (SOC, System Organ Class) tal-MedDRA.
English: Hyperglycaemia Dehydration Hypomagnesaemia Hyponatremia
Maltese: Żieda fil-phosphokinase talkreatinina fid-demm Żieda fid-dehydrogenase tal-lactate fid-demm
English: − One (1) Short needle
Maltese: NETTER-1 (eżitu Olinda)
English: Atrial fibrillation Palpitations Myocardial infarction Angina pectoris Cardiogenic shock
Maltese: Fibrillazzjoni atrijali Palpitazzjonijiet Infart mijokardjali
English: Mechanism of action Lutetium (177Lu) oxodotreotide has a high affinity for subtype 2 somatostatin receptors (sst2).
Maltese: Lutetium (177Lu) oxodotreotide għandu affinità għolja għar-riċetturi tas-somatostatins tas-sottotip 2
English: Any other CTCAE grade 3 or grade 4 toxicity** possibly related to Lutathera.
Maltese: 4** possibbilment relatata ma' Lutathera.
English: Biodistribution studies show that lutetium (177Lu)
Maltese: Radjazzjonijiet jonizzanti ta' lutetium (177Lu)
English: • Renal or urinary tract morphological abnormalities;
Maltese: • Anormalitajiet morfoloġiċi tal-kliewi jew tal-apparat tal-awrina;
English: − One vial of Lutathera
Maltese: − Kunjett wieħed tal-Lutathera
English: In case of severe nausea or vomiting during amino acid solution infusion, an antiemetic of a different pharmacological class can be administered.
Maltese: Fil-każ ta' nawsja severa jew rimettar matul l-infużjoni tas-soluzzjoni ta' aċidi amminiċi, jista' jingħata antiemetiku ta' klassi farmakoloġika differenti.
English: Leukocyturia
Maltese: Lewkoċiturja
English: METHOD OF ADMINISTRATION Single-dose vial.
Maltese: Lutathera jingħata direttament ġol-vini.
English: Dizziness Dysgeusia Headache10
Maltese: Pressjoni tad-demm għolja7
English: The high performance liquid chromatography (HPLC) analyses performed on urine samples collected up to 48 hours post infusion showed lutetium (177Lu) oxodotreotide radiochemical purity close to 100% in most of the analysed samples (with lowest radiochemical purity value being greater than 92%), indicating that the compound is eliminated in urine mainly as intact compound.
Maltese: 100% fil-maġġoranza tal-kampjuni analizzati (bil-valur ta' purità radjukimika l-aktar baxx li kien ikbar minn 92%), li jindika li l-kompost huwa eliminat fl-awrina l-aktar bħala kompost intatt.
English: An analysis performed with human plasma to determine the extent of plasma protein binding of non-radioactive compound (lutetium (175Lu) oxodotreotide) showed that about 50% of the compound is bound to plasmatic proteins.
Maltese: Analiżi mwettqa bil-plażma tal-bniedem sabiex jiġi determinat il-livell ta' rbit mal-proteini tal-plażma tal-kompost mhux radjuattiv (lutetium (175Lu) oxodotreotide) wriet li madwar 50% tal-kompost huwa marbut mal-proteini plażmatiċi.
English: Toxicity with four repeated administrations, once every 2 weeks, of 1,250 µg/kg of the cold compound in rats and 80 µg/kg in dogs was not observed.
Maltese: 1,250 µg/kg tal-kompost kiesaħ fil-firien u 80 µg/kg fil-klieb.
English: Hepatic encephalopathy Paraesthesia Parosmia
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: For instruction on preparation of the medicinal product before administration, see section 12.
Maltese: Għal istruzzjonijiet dwar il-preparazzjoni tal-prodott mediċinali qabel l-għoti, ara sezzjoni 12.
English: Nephrotoxicity Lutetium (177Lu) oxodotreotide is excreted by the kidney.
Maltese: Lutetium (177Lu) oxodotreotide jiġi eliminat mill-kliewi.
English: Hyperparathyroidism
Maltese: Iperidrożi
English: At the cut-off date for post-hoc statistical analysis (30 June 2016), the number of centrally confirmed disease progressions or deaths was 30 events in the Lutathera arm and 78 events in the octreotide LAR arm (Table 9).
Maltese: Fid-data tal-għeluq għall-analiżi tal-istatistika post-hoc (30 ta' Ġunju 2016), in-numru ta' progressjonijiet tal-marda kkonfermati ċentralment kien 30 avveniment fil-fergħa tal-Lutathera u 78
English: Flatulence
Maltese: Nefrotossiċità
English: The infusion of the amino acid solution should start 30 minutes prior to start of Lutathera infusion.
Maltese: L-infużjoni tas-soluzzjoni ta' aċidi amminiċi trid tinbeda 30 minuta qabel ma tibda l-infużjoni tal-Lutathera.
English: The recommended dose is 7,400 MBq (megabecquerel, the unit used to express radioactivity) in a single infusion, which is given at 4 times once every 8 weeks.
Maltese: MBq (megabecquerel, l-unità użata biex tiġi espressa rradjuattività) f'infużjoni waħda, li tingħata 4 darbiet darba kull 8 ġimgħat.
English: NAME OF THE MEDICINAL PRODUCT Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide
Maltese: Stimi tad-dożi assorbiti għal lutetium (177Lu) oxodotreotide mill-istudju tal-fażi
English: When testing the cold compound (non-radioactive lutetium (175Lu) oxodotreotide) as a single intravenous injection in rats and dogs at doses up to 20,000 µg/kg (rats) and 3,200 µg/kg (dogs), the compound was well tolerated in both species and no deaths were observed.
Maltese: Meta l-kompost kiesaħ (lutetium (175Lu) oxodotreotide mhux radjuattiv) kien ittestjat bħala injezzjoni ġol-vini waħda fil-firien u l-klieb b'dożi ta' sa 20,000 µg/kg (firien) u 3,200 µg/kg (klieb), il-kompost kien ittollerat sew fiż-żewġ speċijiet u ma kien hemm l-ebda mewta.
English: Unless your doctor has considered that the clinical benefit of the treatment overcomes the possible risks, you will not be given this medicine: - if you have received a previous external radiation therapy on more than 25% of your bone marrow - if you heart is seriously impaired - if you have seriously affected blood cell counts - if your liver is seriously impaired - if it appears that your tumour does not have sufficient somatostatin receptors
Maltese: Sakemm it-tabib tiegħek ma qiesx li l-benefiċċju kliniku tal-kura huwa ikbar mir-riskji possibbli, inti mhux se tingħata din il-mediċina: - jekk ingħatajt terapija bir-radjazzjoni esterna preċedenti fuq iżjed minn 25% tal-mudullun tiegħek
English: The overall median PFS and OS for the FAS Dutch population with GEP and bronchial NETs (360 patients) as well as per tumour type are presented in Table 11.
Maltese: Il-PFS u l-OS medjani globali għall-popolazzjoni Olandiża FAS b'NETS tal-GEP u tal-bronki (360 pazjent) kif ukoll għal kull tip ta' tumur huma ppreżentati f'Tabella 11.
English: Median 95%CI
Maltese: 9 xhur [95% CI 25.
English: INSTRUCTIONS ON USE
Maltese: Pazjenti ċċensurati
English: The amino acid solution can be prepared as a compounded product, in compliance with the hospital's sterile medicinal product preparation good practices and according to the composition specified in Table 1.
Maltese: Is-soluzzjoni ta' aċidi amminiċi tista' tiġi ppreparata bħala prodott kompost, skont il-prattiki tajbin għall-preparazzjoni ta' prodotti mediċinali sterili tal-isptar u skont il-kompożizzjoni speċifikata f'Tabella 1.
English: Close contact with other people should be restricted during 7 days following an administration of Lutathera, and for children and pregnant women it should be limited to less than 15 minutes for each day while keeping a distance of at least 1 meter.
Maltese: Il-kuntatt mill-qrib ma' persuni oħra għandu jiġi ristrett matul 7 ijiem wara li jingħata l-Lutathera, u għal tfal u nisa tqal, dan għandu jiġi limitat għal inqas minn 15-il minuta għal kull ġurnata filwaqt li tinżamm distanza ta' mill-inqas metru.
English: Rates lower than 320 mL/h are not recommended for commercial solutions.
Maltese: Rati aktar baxxi minn 320 mL/siegħa mhumiex rakkomandati għal soluzzjonijiet kummerċjali.
English: Advanced Accelerator Applications Polska Sp. z o. o. Tel: + 48 22 572 15 55
Maltese: Tel: + 48 22 572 15 55
English: Acute prerenal failure Renal impairment
Maltese: Insuffiċjenza prerenali akuta
English: Specification
Maltese: LISTA
English: The long-term trend of progressive glomerular filtration function deterioration demonstrated in the clinical studies confirms that Lutathera-related nephropathy is a chronic kidney disease that develops progressively over months or years after exposure.
Maltese: Ix-xejra fit-tul ta' deterjorazzjoni progressiva tal-funzjoni tal-filtrazzjoni glomerulali murija fil-provi kliniċi tikkonferma li nefropatija relatata ma' Lutathera hija marda kronika tal-kliewi li tiżviluppa progressivament matul xhur jew snin wara l-esponiment.
English: Ionizing radiations of the medicine may potentially decrease your fertility.
Maltese: Ir-radjazzjonijiet jonizzanti tal-mediċina jistgħu jnaqqsu l-fertilità tiegħek.
English: Website: www.hpra.ie; E-mail: medsafety@hpra.ie Malta: ADR Reporting - Website: www.medicinesauthority.gov.mt/adrportal .
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Administration of the amino acid solution should be initiated 30 minutes before Lutathera infusion, with an infusion rate of 250 to 550 mL/h (depending on the solution type).
Maltese: Lutathera, b'rata tal-infużjoni ta' 250 sa 550 mL/siegħa (skont it-tip ta' soluzzjoni).
English: Bronchial Pancreatic Foregut** Midgut Hindgut
Maltese: Kliewi Fwied Pulmun Muskolu Ovarji** Frixa
English: Thyroid
Maltese: Zaragoza
English: Patients with urinary incontinence
Maltese: Pazjenti b'inkontinenza tal-awrina
English: Lutathera 370 MBq/mL solution for infusion Lutetium (177Lu) oxodotreotide
Maltese: MBq of lutetium (177Lu) oxodotreotide indika li l-porzjon ewlieni (91%)
English: • Bone metastasis;
Maltese: SD = Marda stabbli;
English: The PFS Kaplan-Meier graph for the full analysis set (FAS) at the cut-off date 24 July 2015 is depicted in Figure 3.
Maltese: Fir-rigward tas-sopravivenza globali OS, fiż-żmien tal-analiżi interim (24 ta' Lulju 2015), kien hemm
English: Refractory cytopenia with unilineage dysplasia Nephrogenic anaemia Bone marrow failure Thrombocytopenic purpura
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: Hepatic impairment
Maltese: Axxite emorraġika
English: Gastrointestinal tube insertion Stent placement Abscess drainage Bone marrow harvest Polypectomy
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva ta' dan ilprodott mediċinali
English: Wait 12 weeks after the date of surgery to administer Lutathera.
Maltese: Stenna 12-il ġimgħa wara d-data tal-kirurġija qabel tagħti Lutathera.
English: Orthostatic hypotension Phlebitis
Maltese: Tossiċità fil-mudullun
English: Common (may affect up to 1 in 10 people)
Maltese: Komuni (jistgħu jaffettwaw sa 1 kull 10 persuni)
English: Abdominal distension Diarrhoea
Maltese: Deidratazzjoni Ipomanjesemija Iponatremija
English: DOSIMETRY
Maltese: MEDIĊINALI
English: Oedema peripheral Administration site pain Chills
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Concomitant use of somatostatin analogues
Maltese: Użu fl-istess ħin ta' analogi tas-somatostatins
English: Lutathera is a radiopharmaceutical medicine used for the treatment of certain tumours (gastroenteropancreatic neuroendocrine tumours), which cannot be completely removed from your body by surgery, have spread in your body (metastatic) and does not respond more to your current treatment.
Maltese: Lutathera hija mediċina radjufarmaċewtika użata għall-kura ta' ċerti tumuri (tumuri newroendokrinali gastroenteropankreatiċi), li ma jistgħux jitneħħew kompletament minn ġismek bil-kirurġija, li nfirxu f'ġismek (metastatiċi) u ma jwiġbux għall-kura attwali tiegħek.
English: Other side effects include: nausea and vomiting (usually during the first 24 hours) and decreased appetite.
Maltese: Effetti sekondarji oħra jinkludu: nawsja u rimettar (normalment wara l-ewwel 24 siegħa) u tnaqqis fl aptit.
English: Toxicological studies with rats have demonstrated that a single intravenous injection of up to 4,550 MBq/kg was well tolerated and no deaths were observed.
Maltese: Studji tossikoloġiċi bil-firien urew li injezzjoni ġol-vina waħda ta' sa 4,550 MBq/kg kienet ittollerata sew u li ma kien hemm l-ebda mewta.
English: Absorption The medicinal product is administered intravenously and is immediately and completely bioavailable.
Maltese: Il-prodott mediċinali jingħata ġol-vini u huwa bijodisponibbli immedjatament u kompletament.
English: Gastrointestinal disorders Nausea Vomiting
Maltese: Disturbi gastro-intestinali Nawja Rimettar
English: PFS observed in the NETTER-1 phase III study in patients with progressive midgut carcinoid tumour - cut-off date 24 July 2015 (full analyses set (FAS), N=229)
Maltese: PFS osservata fl-istudju ta' fażi III NETTER-1 f'pazjenti b'tumur karċinojdi fil-parti tan-nofs tal-imsaren progressiv - data tal-għeluq 24 ta' Lulju 2015 (sett ta' analiżi sħiħa (FAS,
English: The following conclusions on treatment with Lutathera were determined from radiation dosimetry evaluations performed in clinical studies:
Maltese: Platti u aċċessorji tal-kamra tal-banju Ħu prekawzjonijiet speċjali matul is-7 ijiem wara l-kura:
English: This medicine is subject to additional monitoring.
Maltese: Lutathera huwa kontroindikat f'nisa tqal.
English: Pharmacotherapeutic group: Other therapeutic radiopharmaceuticals, ATC code: V10XX04
Maltese: Radjufarmaċewtiċi terapewtiċi oħra, Kodiċi ATC:
English: * The concomitant amino acids infusion is always administered at full dose (see section 4.4).
Maltese: * L-infużjoni ta' aċidi amminiċi konkomitanti tingħata dejjem bid-doża sħiħa (ara sezzjoni 4.4).
English: Kidneys
Maltese: Disorjentazzjoni
English: Bronchial
Maltese: Tal-bronki