FrancophonIA/ELRC3.0 huggingface dataset:
English: Adults: An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy).
Maltese: - Infezzjoni b'batterju msejjaħ Helicobacter pylori f'pazjenti b'ulċeri duwodenali u ulċeri tal-istonku flimkien ma' żewġ antibijotiċi (Terapija tal-qerda).
English: In the case of combination therapy, the summaries of product characteristics of the respective medicinal products should be observed.
Maltese: Fil-każ ta' terapija kombinata, is-sommarju tal-karatteristiċi tal-prodotti mediċinali rispettivi għandhom jiġu osservati.
English: Hospital pack with 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.
Maltese: Pakkett tal-isptar b'50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) pillola gastro-reżistenti.
English: - If you are allergic to medicines containing other proton pump inhibitors.
Maltese: - Jekk inti allerġiku/a għal mediċini li fihom inibituri oħra tal-pompa tal-proton.
English: Hypersensitivity to the active substance, substituted benzimidazoles, soya oil or to any of the other excipients.
Maltese: Sensittività eċċessiva għas-sustanza attiva, sostituti ta' benzimidazoles, jew għal xi sustanzi mhux attivi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola gastro-reżistenti fiha 40 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: 49 gastro-resistant tablets 56 gastro-resistant tablets 60 gastro-resistant tablets 84 gastro-resistant tablets 90 gastro-resistant tablets 98 gastro-resistant tablets 98 (2x49) gastro-resistant tablets 100 gastro-resistant tablets 112 gastro-resistant tablets 168 gastro-resistant tablets
Maltese: 90 pillola gastro-reżistenti 98 pillola gastro-reżistenti 98 (2x49) pillola gastro-reżistenti 100 pillola gastro-reżistenti 112-il pillola gastro-reżistenti 168 pillola gastro-reżistenti
English: Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg Protium.
Maltese: Is-Sindrome ta' Zollinger-Ellison u kundizzjonijiet ipersekretorji patoloġiċi oħrajn Għall-immaniġġjar fit-tul tas-Sindrome ta' Zollinger-Ellison u kundizzjonijiet ipersekretorji patoloġiċi oħrajn, il-pazjenti għandhom jibdew il-kura tagħhom b'doża ta' kuljum ta' 80 mg ta' Protium.
English: Lactation
Maltese: Lewkopenja
English: Hospital packs with 50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) gastro-resistant tablets.
Maltese: Pakketti tal-isptar b'50, 90, 100, 140, 140 (10x14), 150 (10x15), 700 (5x140) pillola gastro-reżistenti.
English: headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders.
Maltese: - Mhux Komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1,000) uġigħ ta' ras; sturdament; dijarea; dardir, rimettar; nefħa u gass fl-istonku; stitikezza; ħalq xott; uġigħ u skonfort addominali; raxx tal-ġilda, eksantema, eruzzjoni; ħakk, tħossok dgħajjef, għajjien jew ġeneralment ma tħossokx tajjeb; problemi biex torqod.
English: The substance is almost exclusively metabolized in the liver.
Maltese: Is-sustanza hi kważi metabolizzata esklussivament fil-fwied.
English: Excipients
Maltese: Iponatrimija
English: Disorientation (and all aggrava
Maltese: Diżorjentament (u l-aggravamenti kollha)
English: Protium is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach.
Maltese: Protium hu “inibitur tal-pompa tal-proton” selettiv, mediċina li tnaqqas l-ammont ta' aċidu magħmul fl-istonku tiegħek.
English: One tablet of Protium per day.
Maltese: Pillola waħda ta' Protium kuljum.
English: For the treatment of an infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy).
Maltese: Għall-kura ta' infezzjoni b'batterju msejjaħ Helicobacter pylori f'pazjenti b'ulċeri duwodenali u ulċeri tal-istonku flimkien ma' żewġ antibijotiċi (Terapija li teqred il-batterji).
English: In this leaflet:
Maltese: Gruppi speċjali ta' pazjenti:
English: Co-administration of atazanavir with proton pump inhibitors is not recommended (see section 4.5).
Maltese: L-għoti flimkien ta' atazanavir flimkien ma' inibituri tal-pompa tal-proton mhuwiex rakkomandat (ara sezzjoni 4.5).
English: LIST OF EXCIPIENTS Contains soya oil.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fih żejt tas-sojja.
English: If you have reduced body stores or risk factors for reduced vitamin B12 and receive pantoprazole long-term treatment.
Maltese: B12 u qed tirċievi kura fit-tul b'pantoprazole.
English: Eradication of H. pylori in combination with two appropriate antibiotics In H. pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved.
Maltese: Il-qerda ta' H. pylori flimkien ma' żewġ antibijotiċi adattati F'pazjenti li jkollhom riżultat pożittiv għat-test għal H. pylori b'ulċeri gastriċi u duwodenali, għandha tinkiseb il-qerda tal-mikrobu b'terapija kombinata.
English: Protium and associated names (see Annex I) 40 mg gastro-resistant tablets [See Annex I - To be completed nationally]
Maltese: Protium u ismijiet assoċjati (Ara Anness I) 40 mg pilloli gastro-reżistenti [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastrooesophageal reflux disease
Maltese: Għall-kura ta' sintomi (eż. qrusa fl-istonku, rigurġitazzjoni tal-aċidu, uġigħ meta tibla') assoċjati mal-marda tar-rifluss gastroesofagali
English: Protium and associated names (see Annex I) 20 mg gastro-resistant tablets [See Annex I - To be completed nationally]
Maltese: Protium u ismijiet assoċjati (Ara Anness I) 20 mg pilloli gastro-reżistenti [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: BEFORE YOU TAKE PROTIUM Do not take Protium - If you are allergic (hypersensitive) to pantoprazole, soya oil or to any of the other ingredients of Protium (see section 6).
Maltese: Tiħux Protium - Jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal pantoprazole, żejt tas-sojja jew sustanzi oħra ta' Protium (ara sezzjoni 6).
English: Packs with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.
Maltese: Pakkett b'7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 pillola gastro-reżistenti.
English: Stomach and duodenal ulcers.
Maltese: Kura ta' ulċera duwodenali
English: Yellow, oval, biconvex film-coated tablet imprinted with “P 40” in brown ink on one side.
Maltese: Pillola miksija b'rita, safra, ovali u bikonvessa, stampata b'“P 40” b'linka kannella fuq naħa waħda.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 20 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: Uncommon (affects 1 to 10 users in 1,000) an increase in liver enzymes.
Maltese: - Mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1,000) żieda fl-enzimi tal-fwied.
English: Headache; Dizziness
Maltese: Kunjett mhux miftuħ: sentejn
English: Hypersensitivity to the active substance, substituted benzimidazoles, soya oil or to any of the other excipients or of the combination partners.
Maltese: Sensittività eċċessiva għas-sustanza attiva, sostituti ta' benzimidazoles, għaż-żejt tas-sojja jew għal xi sustanzi mhux attivi.
English: Protium 40 mg is available for this case.
Maltese: Protium 40 mg hu disponibbli f'dan il-każ.
English: Yellow, oval biconvex film coated tablet imprinted with “P20” in brown ink on one side.
Maltese: Pillola miksija b'rita, safra, ovali u bikonvessa, stampata b'“P 20” b'linka kannella fuq naħa waħda.
English: Serious allergic reactions (frequency rare): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke's oedema / angioedema), severe dizziness with very fast heartbeat and heavy sweating.
Maltese: - Mhux magħrufa (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli) Alluċinazzjoni, konfużjoni (speċjalment f'pazjenti bi storja medika ta' dawn is-sintomi); tnaqqis fil-livell ta' sodium fid-demm.
English: Printing ink:
Maltese: Protium jintuża għal:
English: In patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions requiring long-term treatment, pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.
Maltese: F'pazjenti bis-sindrome ta' Zollinger-Ellison u kundizzjonijiet ipersekretorji patoloġiċi oħrajn li jeħtieġu kura fit-tul, pantoprazole, bħal mediċini kollha li jimblukkaw l-aċidu, jista' jnaqqas l-assorbiment ta' vitamina
English: The most commonly reported ADRs are diarrhoea and headache, both occurring in approximately 1 % of patients.
Maltese: L-iktar ADRs li kienu rrappurtati b'mod komuni huma dijarea u wġigħ ta' ras, li t-tnejn iseħħu f'madwar 1% tal-pazjenti.
English: PHARMACEUTICAL FORM AND CONTENTS Pack with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 100, 112, 168 gastro-resistant tablets.
Maltese: U KONTENUT Pakkett b'7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 100, 112, 168 pillola gastro-reżistenti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 40 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: [See Annex I - To be completed nationally] Pantoprazole
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Rare (affect 1 to 10 users in 10,000) an increase in bilirubin; increased fats in the blood.
Maltese: - Rari (jaffettwaw minn 1 sa 10 utenti minn kull 10,000) żieda fil-livell tal-bilirubina; żieda fix-xaħmijiet fid-demm.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 40 mg pantoprazole (as sodium sesquihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett fih 40 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: Although for patients with liver cirrhosis (classes A and B according to Child) the half-life values increased to between 3 and 6 h and the AUC values increased by a factor of 3 - 5, the maximum serum concentration only increased slightly by a factor of 1.3 compared with healthy subjects.
Maltese: Għalkemm għal pazjenti b'ċirrożi tal-fwied (klassijiet A u B skond Child), il-valuri tal-half-life żdiedu għal bejn 3 u 6 sigħat u l-valuri tal-AUC żdiedu b'fattur ta' 3 - 5, il-konċentrazzjoni massima fis-serum żdiedet ftit biss b'fattur ta' 1.3 meta mqabbla ma' persuni b'saħħithom.
English: As with healthy subjects, pantoprazole's half-life is short.
Maltese: Bħal fil-każ ta' persuni b'saħħithom, il-half-life ta' pantoprazole hi qasira.
English: A daily dose of 20 mg pantoprazole (1 tablet of 20 mg pantoprazole) should not be exceeded in patients with severe liver impairment.
Maltese: Doża ta' kuljum ta' 20 mg pantoprazole (1 pillola ta' 20 mg ta' pantoprazole) m'għandhiex tinqabeż f'pazjenti b'indeboliment sever tal-fwied.
English: Tell your doctor immediately if you notice any of the following symptoms: - an unintentional loss of weight - repeated vomiting - difficulty in swallowing - vomiting blood - you look pale and feel weak (anaemia) - you notice blood in your stools - severe and/or persistent diarrhoea, as Protium has been associated with a small increase in infectious diarrhoea.
Maltese: Għid lit-tabib tiegħek immedjatament jekk tinnota kwalunkwe minn dawn li ġejjin: - telf ta' piż mhux intenzjonat - rimettar ripetut - diffikultà biex tibla' - tirremetti d-demm - tidher pallidu u tħossok dgħajjef (anemija) - tinnota demm fl-ippurgar tiegħek - dijarea severa u/jew persistenti, għax Protium kien assoċjat ma' żieda żgħira ta' dijarea infettiva.
English: Adults and adolescents 12 years of age and above Reflux oesophagitis.
Maltese: Adulti u adoloxxenti minn 12-il sena 'l fuq: - Esofagite riflussa.
English: Rash / exanthema / eruption; Pruritus
Maltese: Raxx/raxx filġilda kkaġunat minn xi infezzjoni minn virus/eruzzjoni; Ħakk
English: Reflux oesophagitis.
Maltese: - Żomm dan il-fuljett.
English: gastro-resistant tablets
Maltese: TAL-PRODOTT MEDIĊINALI
English: PHARMACEUTICAL FORM AND CONTENTS Pack with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.
Maltese: U KONTENUT Pakkett b'7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 pillola gastro-reżistenti.
English: Injection site thrombophlebitis
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: The full EPAR for Ninlaro 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: This summary was last updated in 10/2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'10/2017.
English: The most common side effects with Ninlaro taken together with lenalidomide and dexamethasone (seen in more than 1 in 5 people) were diarrhoea, constipation, thrombocytopenia (low blood platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell), peripheral neuropathy (nerve damage in the hands and feet causing tingling or numbness), nausea (feeling sick), peripheral oedema (swelling, especially of the ankles and feet), vomiting and nose and throat infection.
Maltese: L-effetti sekondarji l-aktar komuni b'Ninlaro meħud flimkien ma' lenalidomide u dexamethasone (li dehru f'aktar minn persuna waħda minn kull ħamsa) kienu dijarea, stitikezza, tromboċitopenja (għadd ta' pjastrini tad-demm baxx), newtropenja (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), newropatija periferika (ħsara fin-nervituri tal-idejn u tas-saqajn li tikkawża tnemnim jew tirżiħ), nawżja (tħossok ma tiflaħx), edema periferika (nefħa, speċjalment fl-għekiesi u fis-saqajn), remettar u infezzjoni fl-imnieħer u fil-gerżuma.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ninlaro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Ninlaro is available as capsules (2.3, 3 and 4 mg) to be taken at least one hour before or two hours after food.
Maltese: Ninlaro jiġi bħala kapsuli (2.3, 3 u 4 mg) li għandhom jittieħdu mill-inqas siegħa qabel jew sagħtejn wara l-ikel.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ninlaro on 21/11/2016.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ninlaro fil-21/11/2016.
English: This is a summary of the European public assessment report (EPAR) for Ninlaro.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ninlaro.
English: Ninlaro contains the active substance ixazomib.
Maltese: Ninlaro fih is-sustanza attiva ixazomib.
English: Ninlaro is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow).
Maltese: Ninlaro huwa mediċina kontra l-kanċer użata biex tikkura adulti b'mijeloma multipla (kanċer talmudullun).
English: Why is Ninlaro approved?
Maltese: Għaliex ġie approvat Ninlaro?
English: Similar side effects were seen when lenalidomide and dexamethasone were used without Ninlaro.
Maltese: Effetti sekondarji simili dehru meta lenalidomide u dexamethasone ntużaw mingħajr Ninlaro.
English: Other information about Ninlaro
Maltese: Informazzjoni oħra dwar Ninlaro
English: In a subsequent similar study involving 115 patients, many with advanced disease, those receiving Ninlaro with lenalidomide and dexamethasone lived on average for 6.7 months without their disease getting worse compared with 4 months in those receiving placebo with lenalidomide and dexamethasone.
Maltese: Fi studju simili sussegwenti li kien jinvolvi 115-il pazjent, ħafna bil-marda avvanzata, dawk li kienu qed jirċievu Ninlaro flimkien ma' lenalidomide u dexamethasone għexu medja ta' 6.7 xhur mingħajr ma lmarda tagħhom qalbet għall-agħar meta mqabbla ma' 4 xhur f'dawk li kienu qed jirċievu plaċebo flimkien ma' lenalidomide u dexamethasone.
English: Ninlaro has been investigated in one main study involving 722 adults with multiple myeloma whose disease had not got better or had come back after previous treatment.
Maltese: Ninlaro ġie investigat fi studju ewlieni wieħed li kien jinvolvi 722 adult bil-mijeloma multipla, li l-marda tagħhom ma rrispondietx jew li reġgħet tfaċċat wara kura preċedenti.
English: Ninlaro has been given ‘conditional approval'.
Maltese: Ninlaro ngħata 'approvazzjoni b'kondizzjoni'.
English: What are the risks associated with Ninlaro?
Maltese: X'inhuma r-riskji assoċjati ma' Ninlaro?
English: Because the number of patients with multiple myeloma is low, the disease is considered ‘rare', and Ninlaro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 September
Maltese: Peress li n-numru ta' pazjenti li jbatu minn mijeloma multipla huwa baxx, il-marda titqies bħala 'rari', u fis-27 ta' Settembru 2011, Ninlaro ġie kklassifikat bħala 'mediċina orfni' (mediċina li tintuża f'mard rari).
English: Data from the main study indicate that Ninlaro improves patients' progression-free survival.
Maltese: Data mill-istudju ewlieni indikat li Ninlaro jtejjeb is-sopravivenza mingħajr progressjoni tal-pazjenti.
English: However, there is uncertainty regarding the size of the improvement because further analysis of the data showed a reduced effect.
Maltese: Madankollu, hemm inċertezza dwar id-daqs tattitjib peress li aktar analiżi tad-data wriet inqas effett.
English: What information is still awaited for Ninlaro?
Maltese: Liema informazzjoni għadha mistennija għal Ninlaro?
English: The company that markets Ninlaro will provide the final data from the main study on the effects of the medicine on overall survival.
Maltese: Il-kumpanija li tqiegħed Ninlaro fis-suq ser tipprovdi d-data finali mill-istudju ewlieni dwar l-effetti talmediċina fuq is-sopravivenza ġenerali.
English: For the full list of all side effects and restrictions with Ninlaro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Ninlaro, ara l-fuljett ta' tagħrif.
English: Ninlaro does not seem to significantly increase the frequency of serious side effects when added to lenalidomide and dexamethasone, and offers the convenience of patients being able to take the capsules at home.
Maltese: Ninlaro ma jidhirx li jżid b'mod sinifikanti l-frekwenza ta' effetti sekondarji serji meta jiġi miżjud ma' lenalidomide u dexamethasone, u joffri l-konvenjenza li l-pazjenti jkunu jistgħu jieħdu l-kapsuli d-dar.
English: The active substance in Ninlaro, ixazomib, is a proteasome inhibitor.
Maltese: Is-sustanza attiva f'Ninlaro, l-ixazomib, hija inibitur ta' proteasome.
English: However, because of the uncertainty regarding the size of the improvement following a later analysis, further confirmatory data will need to be provided by the company that markets the medicine.
Maltese: Madankollu, minħabba l-inċertezza dwar id-daqs tat-titjib wara analiżi li saret aktar tard, jeħtieġ li tiġi pprovduta aktar data konfermatorja mill-kumpanija li tqiegħed il-mediċina fis-suq.
English: The European Medicines Agency therefore decided that Ninlaro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għaldaqstant, l-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefi ċċji ta' Ninlaro h riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: Since Ninlaro has been granted a conditional approval, the company that markets Ninlaro will provide further data on the benefits of this medicine from other studies, including a study in patients who have not been treated before.
Maltese: Peress li Ninlaro ngħata approvazzjoni b'kondizzjoni, il-kumpanija li tqiegħed Ninlaro fis-suq sejra tipprovdi aktar data dwar il-benefiċċji ta' din il-mediċina minn studji oħrajn, inkluż studju f'pazjenti li ma ġewx ikkurati qabel.
English: A first analysis of the data indicated that Ninlaro is effective at prolonging the time patients live without their disease getting worse (progression-free survival): patients treated with Ninlaro lived for an average of 21 months without their disease getting worse compared with 15 months in patients given placebo.
Maltese: L-ewwel analiżi tad-data indikat li Ninlaro huwa effettiv biex itawwal iż-żmien tal-għajxien tal-pazjenti mingħajr ma l-marda tagħhom taqleb għall-agħar (sopravivenza mingħajr progressjoni): pazjenti kkurati b'Ninlaro għexu għal medja ta' 21 xahar mingħajr ma l-marda tagħhom qalbet għall-agħar meta mqabbla mal-15-il xahar f'pazjenti li ngħataw plaċebo.
English: How does Ninlaro work?
Maltese: Kif jintuża Ninlaro?
English: The dose may be reduced also in patients with moderately or severely reduced liver function and patients with severely reduced kidney function.
Maltese: Id-doża tista' titnaqqas ukoll fil-pazjenti li jkollhom funzjoni talfwied indebolita moderatament jew b'mod sever u f'pazjenti b'funzjoni tal-kliewi indebolita severament.
English: Contains: sucrose, E 420, E 1520, E 218.
Maltese: TA' EĊĊIPJENTI Fih: sucrose, E 420, E 1520, E 218.
English: PD: progressive disease
Maltese: PD: marda progressiva
English: Breasta, c
Maltese: Sidera, c
English: Linearity / non-linearity
Maltese: Linearità / nuqqas ta' linearità
English: Grades 3 and 4
Maltese: Gradi 3 u 4
English: Study 3 “SCOUT” NCT02637687
Maltese: Studju 3 “SCOUT” NCT02637687
English: - 22 mg sorbitol in 1 mL.
Maltese: - 22 mg sorbitol f'1 mL.
English: - 1.6 mg propylene glycol in 1 mL.
Maltese: - 1.6 mg propylene glycol f'1 mL.
English: Study 2 “NAVIGATE” NCT02576431
Maltese: Studju 2 “NAVIGATE” NCT02576431
English: Cmax was observed to increase slightly by 1.1, 1.1 and 1.5-fold respectively.
Maltese: Cmax ġiet osservata li żdiedet ftit b'1.1, 1.1 u 1.5 darbiet aktar, rispettivament.
English: Larotrectinib was metabolised predominantly by CYP3A4/5 in vitro.
Maltese: Larotrectinib kien metabolizzat b'mod predominanti minn CYP3A4/5 in vitro.
English: Bayer Hungária KFT Tel:+36 14 87-41 00
Maltese: Magyarország Bayer Hungária KFT Tel:+36 14 87-41 00
English: NCT02122913
Maltese: Studju 1 NCT02122913
English: Children (n=15)b
Maltese: (n=15)b
English: Each mL of oral solution contains 295 mg sucrose, 22 mg sorbitol, 1.6 mg propylene glycol and 0.2 mg methyl parahydroxybenzoate.
Maltese: Kull mL ta' soluzzjoni orali fih 295 mg sucrose, 22 mg sorbitol, 1.6 mg propylene glycol u 0.2 mg methyl parahydroxybenzoate.
English: Congenital mesoblastic nephromaa
Maltese: Nefroma mesoblastika konġenitalia
English: In the adult sub-population (n=65), the ORR was 68%.
Maltese: Fis-sottopopolazzjoni adulta (n=65), l-ORR kienet ta' 68%.
English: VITRAKVI is available as a capsule and oral solution formulation.
Maltese: VITRAKVI huwa disponibbli bħala kapsula u formulazzjoni ta' soluzzjoni orali.
English: Adolescents (n=8)c
Maltese: (n=8)c
English: - Store in a refrigerator (2 °C - 8 °C).
Maltese: - Aħżen fi friġġ (2°C - 8°C).
English: Grade 3 ALT and AST increases in 3 (2%) and 2 (2%) patients, respectively.
Maltese: Żidiet fl-ALT u l-AST ta' Grad 3 fi 3 (2%) u 2 (2%) pazjenti, rispettivament.
English: The active substance is larotrectinib.
Maltese: Is-sustanza attiva hi larotrectinib.
English: Patients (n=102)
Maltese: (n=102)
English: Indigo carmine aluminium lake (E 132) Titanium dioxide (E 171) Propylene glycol (E 1520) Dimeticone
Maltese: Indigo carmine aluminium lake (E 132) Titanium dioxide (E 171) Propylene glycol (E 1520)