FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Gutal can be granted provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc in the environment, are added to the product information.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-awtorizzazzjoni għattqegħid fis-suq għal Gutal tista' tingħata sakemm il-miżuri ta' mitigazzjoni tar-riskju rrakkomandati, li huma mbassra li jnaqqsu l-akkumulazzjoni ta' żingu fl-ambjent, jiżdiedu mal-informazzjoni tal-prodott.
English: The product is indicated for the prevention of post-weaning diarrhoea in piglets.
Maltese: Il-prodott huwa indikat għall-prevenzjoni ta' dijarrea wara l-ftim tal-qżieqeż.
English: Therefore, the Committee recommended several risk mitigation measures to be included in the product information, which are anticipated to reduce the accumulation of zinc in the environment.
Maltese: Għalhekk, il-Kumitat irrakkomanda li jiġu inklużi diversi miżuri ta' mitigazzjoni tar-riskju fl-informazzjoni tal-prodott, li huma antiċipati li jnaqqsu l-akkumulazzjoni ta' żingu fl-ambjent.
English: The full EPAR for Sancuso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: EPAR summary for the public granisetron
Maltese: Sommarju tal-EPAR għall-pubbliku granisetron
English: Sancuso is a ‘hybrid generic medicine'.
Maltese: Sancuso huwa ‘mediċina ġenerika ibrida'.
English: The active substance in Sancuso, granisetron, is a ‘5HT3 antagonist'.
Maltese: Is-sustanza attiva f'Sancuso, il-granisetron, hija ‘antagonist ta' 5HT3'.
English: Each patch releases 3.1 mg of granisetron over 24 hours.
Maltese: Kull garża terħi 3.1 mg ta' granisetron kull 24 siegħa.
English: Sancuso transdermal patch showed similar effects to granisetron given by mouth in the prevention of vomiting and nausea after chemotherapy: 60.2% of patients receiving the Sancuso transdermal patch (171 out of 284 patients) had their nausea and vomiting under control, compared with 64.8% of patients taking granisetron by mouth (193 out of 298 patients).
Maltese: 60.2 % tal-pazjenti li ngħataw il-garża Sancuso li tipprovdi mediċina li tgħaddi minn ġol-ġilda (171 minn 284 pazjent) irnexxielhom jikkontrollaw id-dardir u r-rimettar tagħhom, meta mqabbla ma' 64.8 % tal-pazjenti li ħadu l-granisetron mill-ħalq (193 minn 298 pazjent).
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but given in a different way.
Maltese: Dan ifisser li hija simili għal ‘mediċina ta' referenza' li fiha listess sustanza attiva, iżda li tingħata b'mod differenti.
English: Other information about Sancuso
Maltese: Informazzjoni oħra dwar Sancuso
English: This is a summary of the European public assessment report (EPAR) for Sancuso.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Sancuso.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sancuso on 20 April 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Sancuso fi 20 ta' April 2012.
English: Sancuso is a medicine that contains the active substance granisetron.
Maltese: Sancuso huwa mediċina li fiha s-sustanza attiva granisetron.
English: The most common side effect with Sancuso (seen in between 1 and 10 patients in 100) is constipation.
Maltese: L-effett sekondarju l-aktar komuni b'Sancuso (li deher f'bejn pazjent 1 u 10 minn kull 100) huwa listitikezza.
English: This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
Maltese: Dan ifisser li twaqqaf kimika filġisem imsejħa 5-hydroxytryptamine (5HT, magħrufa wkoll bħala serotonina) milli teħel ma' riċetturi ta' 5HT3 fil-musrana.
English: Why has Sancuso been approved?
Maltese: Għaliex ġie approvat Sancuso?
English: This was defined as having no vomiting or retching (strong involuntary contractions of the stomach with the urge to vomit), no more than mild nausea and no need to take other anti-emetic medicines for quick relief after receiving chemotherapy.
Maltese: Dan kien definit bħala nuqqas totali ta' rimettar jew tqalligħ (kontrazzjonijiet involontarji qawwija tal-istonku bl-impuls tar-rimettar), xejn ħlief dardir ħafif u l-ebda ħtieġa ta' xi mediċina antiemetika oħra sabiex is-sintomi jittaffew malajr wara li l-pazjent jirċievi l-kemjoterapija.
English: One transdermal patch is applied 24 to 48 hours before chemotherapy.
Maltese: Garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda tiġi applikata 24 sa 48 siegħa qabel il-bidu tal-kura bil-kemjoterapija.
English: Sancuso is an ‘anti-emetic', a medicine that prevents nausea (feeling sick) and vomiting.
Maltese: Sancuso huwa ‘antiemetiku', mediċina li tipprevjeni n-nawżja (id-dardir) u r-rimettar.
English: The benefit of Sancuso in the prevention of nausea and vomiting caused by chemotherapy was investigated in one main study involving a total of 641 patients.
Maltese: Il-benefiċċju ta' Sancuso fil-prevenzjoni tad-dardir u tar-rimettar ikkawżati mill-kemjoterapija kien investigat fi studju ewlieni li kien jinvolvi total ta' 641 pazjent.
English: What is Sancuso?
Maltese: X'inhu Sancuso?
English: How has Sancuso been studied?
Maltese: Kif ġie studjat Sancuso?
English: Because Sancuso is a hybrid generic, the applicant presented comparative data on the reference medicine in addition to results from its own studies.
Maltese: Minħabba li Sancuso huwa ġeneriku ibridu, l-applikant ippreżenta dejta komparattiva dwar il-mediċina ta' referenza flimkien ma' riżultati mill-istudji tiegħu stess.
English: What is the risk associated with Sancuso?
Maltese: X'inhu r-riskju assoċjat ma' Sancuso?
English: The Committee considered that Sancuso transdermal patch showed a similar benefit to granisetron taken by mouth but that it may have a slower onset of action.
Maltese: Għaldaqstant, is-CHMP iddeċieda li lbenefiċċji ta' Sancuso huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għattqegħid fis-suq.
English: When 5HT attaches to these receptors, it normally causes nausea and vomiting.
Maltese: Meta 5HT jeħel ma' dawn ir-riċetturi, normalment jikkawża d-dardir u r-rimettar.
English: By blocking these receptors, Sancuso prevents the nausea and vomiting that often happen after certain types of chemotherapy.
Maltese: Blimblukkar ta' dawn ir-riċetturi, Sancuso jipprevjeni d-dardir u r-rimettar li spiss iseħħu wara ċerti tipi ta' kemjoterapija.
English: It is used to prevent nausea and vomiting caused by types of chemotherapy (medicines used to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Maltese: Jintuża għallprevenzjoni tad-dardir u r-rimettar ikkawżati minn tipi ta' kemjoterapija (mediċini li jintużaw għall-kura tal-kanċer) li jikkawżaw dardir u rimettar b'mod moderat jew qawwi.
English: EMA/205979/2019 EMEA/H/C/003691
Maltese: EMA/205979/2019 EMA/H/C/003691
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
English: Further information on Zynteglo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynteglo.
Maltese: ema.europa.eu/medicines/human/EPAR/zynteglo.
English: Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) EMA/205979/2019
Maltese: Zynteglo (ċelloli awtologi CD34+ li jikkodifikaw il-ġene tal-globina βA-T87Q)
English: Beta thalassaemia is rare, and Zynteglo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 January 2013.
Maltese: Il-beta talassemija hija rari, u Zynteglo ġie denominat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fl-24 ta' Jannar 2013.
English: Other information about Zynteglo
Maltese: Informazzjoni oħra dwar Zynteglo
English: What information is still awaited for Zynteglo?
Maltese: Liema informazzjoni għadha mistennija għal Zynteglo?
English: As for all medicines, data on the use of Zynteglo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Zynteglo hija ssorveljata kontinwament.
English: The company that markets Zynteglo will provide educational materials for healthcare professionals expected to use the medicine with information on its safety, including the potential risks of cancer and bleeding, and how it should be given.
Maltese: Il-kumpanija li tqiegħed Zynteglo fis-suq se tipprovdi materjali edukattivi għall-professjonisti fil-qasam tal-kura tas-saħħa mistennija li jużaw il-mediċina b'informazzjoni dwar is-sigurtà tiegħu, inklużi r-riskji potenzjali tal-kanċer u tal-fsada, u kif għandu jingħata.
English: Zynteglo contains as its active substance stem cells taken from the patients that have been genetically modified to contain a working gene for beta-globin.
Maltese: Zynteglo fih bħala s-sustanza attiva tiegħu ċelloli staminali meħuda mill-pazjenti li jkunu ġew ġenetikament modifikati biex jinkludu ġene li taħdem għall-beta-globina.
English: What are the risks associated with Zynteglo?
Maltese: X'inhuma r-riskji assoċjati ma' Zynteglo?
English: Regarding safety, because Zynteglo is produced using a virus, there could be a theoretical risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far.
Maltese: Fir-rigward tas-sigurtà, minħabba li Zynteglo huwa prodott bl-użu ta' virus, jista' jkun hemm ir-riskju teoretiku ta' kanċer ikkawżat minn bidliet mhux intenzjonati fil-materjal ġenetiku, għalkemm ma ġewx irrapportati każijiet bħal dawn s'issa.
English: How is Zynteglo used?
Maltese: Zynteglo?
English: Zynteglo can only be obtained with a prescription and must be given in an approved centre by a doctor experienced in stem cell transplantation and in the treatment of beta thalassaemia.
Maltese: Zynteglo jista' jinkiseb biss b'riċetta ta' tabib u għandu jingħata biss f'ċentru approvat minn tabib b'esperjenza fit-trapjanti taċ-ċelloli staminali u fil-kura tal-beta talassemija.
English: Zynteglo is a medicine used to treat a blood disorder known as beta thalassaemia in patients 12 years and older who require regular blood transfusions.
Maltese: Zynteglo huwa mediċina li tintuża għall-kura ta' disturb fid-demm magħruf bħala beta talassemija f'pazjenti li għandhom 12 'il sena jew aktar u li jeħtieġu trasfużjonijiet regolari tad-demm.
English: How does Zynteglo work?
Maltese: Kif jintuża Zynteglo?
English: People with this genetic condition cannot make enough beta-globin, a component of haemoglobin, the protein in red blood cells that carries oxygen around the body.
Maltese: Il-persuni b'din il-kundizzjoni ġenetika ma jistgħux jipproduċu biżżejjed beta-globina, komponent talemoglobina, il-proteina fiċ-ċelloli ħomor tad-demm li ġġorr l-ossiġnu mal-ġisem.
English: To make Zynteglo, the stem cells taken from the patient's blood are modified by a virus that carries working copies of the beta-globin gene into the cells.
Maltese: Biex isir Zynteglo, iċ-ċelloli staminali meħuda mid-demm tal-pazjent jiġu modifikati minn virus li jġorr kopji li jaħdmu tal-ġene beta-globina fiċ-ċelloli.
English: Transfusion-dependent beta thalassaemia is a severe condition for which treatment options are limited.
Maltese: Il-beta talassemija dipendenti mit-trasfużjoni hija kundizzjoni severa li għaliha l-għażliet ta' kura huma limitati.
English: Zynteglo is used in patients who do not completely lack beta-globin and who are eligible for stem cell transplantation but do not have a matching related donor.
Maltese: Zynteglo jintuża f'pazjenti li ma jkunux kompletament neqsin mill-beta-globina u li huma eliġibbli għal trapjant taċ-ċelloli staminali iżda li ma għandhomx donatur korrispondenti relatat.
English: Why is Zynteglo authorised in the EU?
Maltese: Għaliex Zynteglo ġie awtorizzat fl-UE?
English: In these studies, out of the 14 patients who did not completely lack beta-globin and were given Zynteglo, 11 of them had sufficiently high levels of red blood cells so that they did not need blood transfusions for at least 1 year after treatment.
Maltese: F'dawn l-istudji, minn 14-il pazjent li ma kinux kompletament neqsin mill-beta-globina u li ngħataw Zynteglo, 11 minnhom kellhom livelli għoljin biżżejjed ta' ċelloli ħomor tad-demm u għaldaqstant ma kinux jeħtieġu trasfużjonijiet tad-demm għal tal-inqas sena wara l-kura.
English: Although information on the safety of the medicine is limited because of the small number of patients treated to date and the lack of long-term data, the European Medicines Agency decided that Zynteglo's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: Għalkemm l-informazzjoni dwar is-sigurtà tal-mediċina hija limitata minħabba l-għadd żgħir ta' pazjenti kkurati s'issa u n-nuqqas ta' data fit-tul, l-Aġenzija Ewropea għall-Mediċini ddeċidiet li lbenefiċċji ta' Zynteglo huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: active hepatitis).
Maltese: epatite attiva).
English: United States (USA)
Maltese: L-Stati Uniti (USA)
English: B-1930, Zaventem Belgium
Maltese: B-1930, Zaventem
English: Sucrose Polysorbate 80 Sodium chloride Tromethamine
Maltese: Polysorbate 80 Sodium chloride Tromethamine
English: > 28 days
Maltese: > 28 jum
English: MedDRA System organ class Very common
Maltese: Sistema tal-klassifika talorgani ta' MedDRA
English: 28 dayse
Maltese: 28 jum
English: HIDAC, FLAG, or MXN/Ara-C (N=109)
Maltese: HIDAC, FLAG, jew MXN/Ara-C (N=109)
English: Decreased appetite (12%)
Maltese: Nuqqas ta' aptit (12%)
English: Dose (mg/m2)
Maltese: Doża (mg/m
English: [6.0 to 9.2]
Maltese: [6.0 sa 9.2]
English: HIDAC, FLAG, or MXN/Ara-C (N=162)
Maltese: HIDAC, FLAG, jew MXN/Ara-C (N=162)
English: Hypersensitivity (1%)
Maltese: Sensittività eċċessiva (1%)
English: Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agent, monoclonal antibodies, ATC code: L01XC26.
Maltese: Aġenti antineoplastiċi, aġenti antineoplastiċi oħra, antikorp monoklonali, Kodiċi ATC: L01XC26.
English: Increased alkaline phosphatase
Maltese: Żieda fl-alkaline phosphatase
English: 2-sided p-value < 0.0001 BESPONSA (N=164)
Maltese: valur-p b'żewġ naħat < 0.0001 BESPONSA (N=164)
English: Total bilirubin > 1.5 × ULN and AST/ALT > 2.5 × ULN
Maltese: Bilirubina totali > 1.5 × ULN u AST/ALT > 2.5 × ULN
English: The mean (SD) maximum serum concentration (Cmax) of inotuzumab ozogamicin was 308 ng/mL (362).
Maltese: Ilkonċentrazzjoni massima fis-seru (Cmax) medja (SD) ta' inotuzumab ozogamicin kienet ta' 308 ng/mL (362).
English: ANC was ≥ 1 × 109/L
Maltese: ANC kien ≥ 1 × 10 9/L
English: In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide is a substrate of P-glycoprotein (P-gp).
Maltese: In vitro, N-acetyl-gamma-calicheamicin dimethylhydrazide huwa substrat ta' P-glycoprotein (P-gp).
English: A total of 276 (85%) patients had Ph- ALL.
Maltese: Total ta' 276 (85%) pazjent kellhom Ph- All.
English: Pancytopeniab (2%)
Maltese: Panċitopenija b (2%)
English: Tumour lysis syndrome (TLS)
Maltese: Sindrome ta' lisi tat-tumur (TLS)
English: • The active substance is inotuzumab ozogamicin.
Maltese: • Is-sustanza attiva hija inotuzumab ozogamicin.
English: Fatal infections, including pneumonia, neutropenic sepsis, sepsis, septic shock, and pseudomonal sepsis, were reported in 8 (5%) patients.
Maltese: Infezzjonijiet fatali, inklużi pnewmonja, sepsis newtropenika, sepsis, xokk settiku, u sepsis psewdomonali, ġew irrappurtati fi 8 (5%) pazjent.
English: Ascites (4%) Abdominal distension (6%)
Maltese: Axxite (4%) Nefħa addominali (6%)
English: An increase in QTcF interval of > 450 msec was observed in 26/162 (16%) patients.
Maltese: Żidiet fl-interval QTcF ta' > 450 msec ġew osservati f'26/162 (16%) pazjent.
English: All events were Grade ≤ 2 in severity.
Maltese: L-episodji kollha kienu ta' Grad ≤ 2 fis-severità.
English: The most common (≥ 20%) adverse reactions were thrombocytopenia (51%), neutropenia (49%), infection (48%), anaemia (36%), leukopenia (35%), fatigue (35%), haemorrhage (33%), pyrexia (32%), nausea (31%), headache (28%), febrile neutropenia (26%), increased transaminases (26%), abdominal pain (23%), increased gamma-glutamyltransferase (21%), and hyperbilirubinaemia (21%).
Maltese: L-aktar reazzjonijiet avversi komuni (≥ 20%) kienu tromboċitopenija (51%), newtropenija (49%), infezzjoni (48%), anemija (36%), lewkopenija (35%), għeja (35%), emorraġija (33%), deni (32%), dardir (31%), uġigħ ta' ras (28%), newtropenija bid-deni (26%), żieda fit-transaminases (26%), uġigħ addominali (23%), żieda fil-gamma-glutamyltransferase (21%), u iperbilirubinimja (21%).
English: Febrile neutropenia (26%) Neutropenia (49%) Thrombocytopenia (51%) Leukopenia (35%) Lymphopenia (18%) Anaemia (36%)
Maltese: Newtropenija bid-deni (26%) Newtropenija (49%) Tromboċitopenija (51%) Lewkopenija (35%) Limfopenija (18%) Anemija (36%)
English: [2.8 to 4.6] Hazard ratio [95% CI] = 0.471 [0.366-0.606] 2-sided p-value < 0.0001
Maltese: [2.8 sa 4.6] Proporzjon ta' periklu [95% CI] = 0.471 [0.366-0.606] valur-p b'żewġ naħat < 0.0001
English: [4.7 to 8.3] Hazard ratio [95% CI] = 0.751 [0.588-0.959] 2-sided p-value = 0.0210
Maltese: [4.7 sa 8.3] Proporzjon ta' periklu [95% CI] = 0.751 [0.588-0.959] valur-p b'żewġ naħat = 0.0210
English: The final concentration should be between 0.01 and 0.1 mg/mL.
Maltese: Il-konċentrazzjoni finali għandha tkun bejn 0.01 u 0.1 mg/mL.
English: Date of first authorisation: 29 June 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 29 ta' Ġunju 2017
English: Abbreviations: ALL=acute lymphoblastic leukaemia; ECG=electrocardiogram; GGT=gamma-glutamyltransferase; HSCT=haematopoietic stem cell transplant.
Maltese: ECG=elettrokardjogramm; GGT=gamma-glutamyltransferase;
English: The adverse reactions are presented by system organ class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma skont is-sistema tal-klassifika tal-organi (SOC, system organ class) u lkategoriji ta' frekwenza, definiti bl-użu tal-konvenzjoni li ġejja: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: ≥ 7 days
Maltese: ≥ 7 ijiem
English: • Add the reconstituted solution to an infusion container with sodium chloride 9 mg/mL (0.9%) solution for injection, to a total nominal volume of 50 mL.
Maltese: • Żid is-soluzzjoni rikostitwita f'kontenitur tal-infużjoni b'soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) għall-injezzjoni, għal volum nominali totali ta' 50 mL.
English: Hepatotoxicity, including venoocclusive liver disease/sinusoidal obstruction syndrome (VOD/SOS)
Maltese: Epatotossiċità, inkluż marda tal-fwied venookklużiva/sindrome ta' ostruzzjoni sinusojdali (VOD/SOS)
English: By central and local laboratory tests, 231/253 (91.3%) patients and 130/253 (51.4%) patients, respectively, had ≥ 70% CD22-positive leukaemic blasts at baseline.
Maltese: Permezz ta' testijiet tal-laboratorju ċentrali u lokali, 231/253 (91.3%) pazjent u 130/253 (51.4%) pazjent, rispettivament, kellhom> 70% pożittività ta' CD22 ta' blast lewkemiku fil-linja bażi.
English: No adjustment to the starting dose is required in patients with hepatic impairment defined by total bilirubin ≤ 1.5 × upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament fid-doża tal-bidu f'pazjenti b'indeboliment tal-fwied definit mill-bilirubina totali ≤ 1.5 × limitu ta' fuq tan-normal (ULN) u aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × ULN (ara s-sezzjoni 5.2).
English: The median age was 45 years (range 20-79); 76.4% were Salvage status ≥ 2; 31.9% had received a prior HSCT and 22.2% were Ph+.
Maltese: L-età medjana kienet 45 sena (medda 20-79); 76.4% kienu istatus Salvage ≥ 2; 31.9% kienu rċevew HSCT minn qabel u 22.2% kienu Ph +.
English: Haematological toxicity
Maltese: Tossiċità Ematoloġika
English: • The other ingredients are sucrose, polysorbate 80, sodium chloride, and tromethamine.
Maltese: • Is-sustanzi mhux attivi l-oħra huma sukrożju, polysorbate 80, sodium chloride, u tromethamine.
English: a Infection also includes other types of infection (11%).
Maltese: Infezzjoni tinkludi tipi oħrajn ta' infezzjoni (11%).
English: < 7 days (within a cycle)
Maltese: < 7 ijiem (fi ħdan ċiklu)
English: ECG QT prolonged (1%) Increased amylase (5%)
Maltese: Titwil tal-ECG QT (1%) Żieda fl-amylase (5%) Żieda fil-lipase (9%)
English: a +/- 2 days (maintain minimum of 6 days between doses).
Maltese: +/- jumejn (żomm minimu ta' 6 ijiem bejn id-dożi).
English: Abdominal pain (23%) Vomiting (15%) Diarrhoea (17%) Nausea (31%) Stomatitis (13%) Constipation (17%)
Maltese: Uġigħ addominali (23%) Rimettar (15%) Dijarea (17%) Dardir (31%) Stomatite (13%) Stitikezza (17%)
English: In the Phase 2 portion of the study, 8/35 (22.9%) patients had a follow-up HSCT.
Maltese: Fil-porzjon ta' Fażi 2 tal-istudju, 8/35 (22.9%) pazjent kellhom HSCT ta' segwitu.
English: Grade 4 thrombocytopenia and neutropenia were reported in 46 (28%) and 45 (27%) patients, respectively.
Maltese: Tromboċitopenija u newtropenija ta' Grad 4 ġew irrappurtati f'46 (28%) u 45 (27%) pazjent, rispettivament.
English: Venoocclusive liver disease (sinusoidal obstruction syndrome) (3% [pre-HSCT]d)
Maltese: Marda tal-fwied venookklużiva (sindrome ta' ostruzzjoni sinusojdali) [3% qabel l-HSCT]
English: The safety and efficacy of BESPONSA were evaluated in a single-arm, open-label, multicentre Phase 1/2 study (Study 2).
Maltese: Is-sigurtà u l-effikaċja ta' BESPONSA ġew evalwati fi studju ta' Fażi 1/2, b'parti waħda tal-istudju, open-label, u multiċentriku (Studju 2).
English: ≥ 14 days
Maltese: ≥ 14-il jum
English: 2-sided p-value = 0.0022
Maltese: valur-p b'żewġ naħat = 0.0022
English: In patients who underwent a follow-up HSCT, the median OS was 11.9 months (95% CI: 9.2, 20.6) for BESPONSA versus 19.8 months (95% CI: 14.6, 26.7) for Investigator's choice of chemotherapy.
Maltese: F'pazjenti li għaddew minn HSCT ta' segwitu, l-OS medjan kien 11.9 xhur (95% CI: 9.2, 20.6) għal BESPONSA kontra 19.8 xhur (95% CI: 14.6, 26.7) għall-kimoterapja tal-għażla tal-Investigatur.
English: Injury, poisoning and procedural complications
Maltese: Feriti, avvelenament u komplikazzjonijiet ta' xi proċedura
English: • BESPONSA contains no bacteriostatic preservatives.
Maltese: • BESPONSA ma fih l-ebda preservattivi batterjostatiċi.
English: An infusion container made of polyvinyl chloride (PVC) (di(2-ethylhexyl)phthalate [DEHP]- or non-DEHP-containing), polyolefin (polypropylene and/or polyethylene), or ethylene vinyl acetate (EVA) is recommended.
Maltese: Huwa rakkomandat kontenitur talinfużjoni magħmul minn polyvinyl chloride (PVC) (di(2-ethylhexyl)phthalate [DEHP]- jew li ma jkunx fih DEHP), polyolefin (polypropylene u/jew polyethylene), jew ethylene vinyl acetate (EVA).
English: Each carton contains 1 vial.
Maltese: Kull pakkett fih kunjett 1.
English: In the pivotal study (N=164), infusion related reactions were reported in 17 (10%) patients.
Maltese: Fl-istudju importanti ħafna (N=164) ,ġew irrappurtati reazzjonijiet relatati mal-infużjoni fi 17 (10%) pazjent.
English: Myelosuppression/cytopenias
Maltese: Majelosoppressjoni/ċitopenija