FrancophonIA/ELRC3.0 huggingface dataset:
English: Included subjects who had ≥ 50 copies/mL in the Week 48/96 window; subjects who discontinued early due to lack or loss of efficacy per investigator's assessment; subjects who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value ≥ 50 copies/mL.
Maltese: Kien jinkludi individwi li kellhom ≥ 50 kopja/mL fil-perjodu ta' Ġimgħa 48/96; individwi li waqfu kmieni minħabba nuqqas jew telf ta' effikaċja skont l-istima tal-investigatur; individwi li waqfu minħabba raġunijiet li ma kinux avveniment avvers (AE, adverse event), mewt jew nuqqas jew telf ta' effikaċja u li fiż-żmien tal-waqfien kellhom valur virali ≥ 50 kopja/mL.
English: Clinical monitoring is recommended when co-administering Symtuza with corticosteroids.
Maltese: Huwa rrakkomandat monitoraġġ kliniku meta Symtuza jingħata mal-kortikosterojdi.
English: • abnormal blood test results such as some tests for your pancreas.
Maltese: • riżultati mhux normali ta' testijiet tad-demm bħal xi testijiet tal-frixa.
English: common pruritus, urticaria uncommon angioedema rare drug reaction with eosinophilia and systemic symptoms a, Stevens-Johnson syndrome not known toxic epidermal necrolysis a, acute generalised exanthematous pustulosis
Maltese: Tiħux Symtuza - jekk inti allerġiku/a (għandek sensittività eċċessiva) għal darunavir, cobicistat, emtricitabine,
English: Based on theoretical considerations DRV/COBI is expected to increase digoxin plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI huwa mistenni li jżid ilkonċentrazzjonijiet ta' digoxin filplażma.
English: Based on this limited experience, the safety profile of emtricitabine/tenofovir alafenamide in patients with HIV/HBV co-infection appears to be similar to that in patients with HIV-1 monoinfection (see section 4.4).
Maltese: Abbażi ta' din l-esperjenza limitata, il-profil ta' sigurtà ta' emtricitabine/tenofovir alafenamide f'pazjenti koinfettati b'HIV/HBV tidher li tixbah dik ta' pazjenti b'infezzjoni ta' HIV-1 waħedha (ara sezzjoni 4.4).
English: Interaction trials with the components of Symtuza have only been performed in adults.
Maltese: Provi ta' interazzjoni bil-komponenti ta' Symtuza saru biss fl-adulti.
English: In vitro studies indicate that emtricitabine is not an inhibitor of human CYP enzymes.
Maltese: Studji in vitro jindikaw li emtricitabine mhuwiex inibitur tal-enzimi CYP tal-bniedem.
English: The EC50 values for emtricitabine were in the range of 0.0013 to 0.64 μM.
Maltese: b'valuri EC50 li jvarjaw minn < 0.1 sa 4.3 nM.
English: Based on theoretical considerations St. John's wort is expected to decrease darunavir and/or cobicistat and/or tenofovir alafenamide plasma concentrations.
Maltese: John's wort huwa mistenni li jnaqqas ilkonċentrazzjonijiet ta' darunavir u/jew cobicistat u/jew tenofovir alafenamide fil-plażma.
English: (CYP3A and/or P-gp induction)
Maltese: (inibizzjoni ta' CYP3A u/jew ta' P-gp)
English: Co-administration of Symtuza and ergot derivatives is contraindicated (see section 4.3).
Maltese: L-għoti ta' Symtuza flimkien mad-derivati tal-ergot huwa kontraindikat (ara sezzjoni 4.3).
English: No dose adjustment of Symtuza is required in patients with estimated glomerular filtration rate according to the Cockcroft-Gault formula (eGFRCG) ≥ 30 mL/min.
Maltese: Matul terapija għall-HIV jista' jkun hemm żieda fil-piż u fil-livelli tax-xaħmijiet u taz-zokkor fiddemm.
English: The dosage of other medicines might need to be changed since either their own or Symtuza's therapeutic effect or side effects may be influenced when combined.
Maltese: L-effetti ta' mediċini oħra jistgħu jiġu influwenzati jekk inti tieħu Symtuza.
English: Latina Italy
Maltese: Latina
English: The pharmacokinetics of emtricitabine have not been studied in patients with hepatic impairment; however, emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Maltese: Il-farmakokinetika ta' emtricitabine ma ġietx studjata f'pazjenti b'indebolimenttal-fwied; madankollu, emtricitabine ma jiġix metabolizzat b'mod sinifikanti mill-enzimi tal-fwied, u għalhekk l-impatt ta' indeboliment tal-fwied għandu jkun limitat.
English: Based on theoretical considerations DRV/COBI may increase ergot derivative exposure.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi DRV/COBI jista' jżid lesponiment għad-derivati tal-ergot.
English: EMA/776441/2018 EMEA/H/C/000074
Maltese: EMA/776441/2018 EMA/H/C/000074
English: Further information on NovoSeven can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/novoseven.
Maltese: ema.europa.eu/medicines/human/EPAR/novoseven.
English: • congenital factor VII deficiency;
Maltese: • defiċjenza konġenitali tal-fattur VII;
English: Other information about NovoSeven
Maltese: Informazzjoni oħra dwar NovoSeven
English: However the following side effects may affect between 1 and 10 patients in 1,000: venous thromboembolic events (problems caused by blood clots in the veins), rash, pruritus (itching), urticaria (hives), fever and reduced effectiveness of treatment.
Maltese: Madankollu, l-effetti sekondarji li ġejjin jistgħu jaffettwaw bejn pazjent wieħed u 10 pazjenti f'1,000: episodji tromboemboliċi venużi (problemi kkawżati mill-koagulazzjonijiet fil-vini), raxx, prurite (ħakk), urtikarja (ħorriqija), deni u tnaqqis fleffikaċja tal-kura.
English: 270 micrograms/kg may be used in adults with a mild or moderate bleeding episode.
Maltese: Tista' tintuża doża singola ta' 270 mikrogramma/kg fl-adulti li jkollhom episodju ta' emorraġija ħafifa jew moderata.
English: Data on the use of NovoSeven in patients with Glanzmann's thrombasthenia were obtained from a registry of patients treated with the medicine, which showed that treatment with NovoSeven was successful in 79% of the bleeding episodes (262 out of 333) and 88% of the surgeries (140 out of
Maltese: Id-data dwar l-użu ta' NovoSeven fuq pazjenti bi trombastenija ta' Glanzmann inkisbet minn reġistru ta' pazjenti kkurati bil-mediċina, u wriet li l-kura b'NovoSeven kellha suċċess f'79 % tal-episodji ta' emorraġija (262 minn 333) u fi 88 % tal-kirurġiji (140 minn 159).
English: NovoSeven contains the active substance eptacog alfa.
Maltese: NonoSeven fih is-sustanza attiva eptacog alfa.
English: In a study involving 61 haemophilia patients with inhibitors, 84% of the 57 serious bleeds and 59% of the 38 surgical bleeds were controlled effectively with NovoSeven.
Maltese: Fi studju li fih ħadu sehem 61 pazjent b'emofilja b'inibituri, 84 % tas-57 emorraġija gravi u 59 % tat38 emorraġija kirurġika ġew ikkontrollati b'mod effikaċi b'NovoSeven.
English: NovoSeven received a marketing authorisation valid throughout the EU on 23 February 1996.
Maltese: NovoSeven ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-23 ta' Frar 1996.
English: • In Glanzmann's thrombasthenia, the dose is 90 micrograms/kg every 2 hours, for at least three doses.
Maltese: • Fi trombastenija ta' Glanzmann, id-doża hija 90 mikrogramma/kg kull sagħtejn, għal minn talinqas tliet dożi.
English: • In factor VII deficiency, the dose is 15 to 30 micrograms/kg every 4 to 6 hours until the bleeding is controlled.
Maltese: • Fid-defiċjenza tal-fattur VII, id-doża hija ta' 15 sa 30 mikrogramma/kg kull erbgħa sa sitt sigħat sakemm ma l-emorraġija tiġi kkontrollata.
English: What are the risks associated with NovoSeven?
Maltese: X'inhuma r-riskji assoċjati ma' NovoSeven?
English: In another study in 60 patients with mild to moderate bleeding episodes, which investigated whether NovoSeven could be used in the home setting, 90% of the bleeding episodes were controlled effectively.
Maltese: Fi studju ieħor fuq 60 pazjent b'episodji ta' emorraġija ħfief sa moderati, li investiga jekk NovoSeven setax jintuża fl-ambjent taddar, 90 % tal-episodiji ta' emorraġija ġew ikkontrollati b'mod effettiv.
English: • congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop ‘inhibitors' (antibodies) against factor VIII or IX;
Maltese: • emofilja konġenitali (disturb ta' emorraġija li jkun jeżisti sa mit-twelid) li jkunu żviluppaw jew li jkunu mistennija li jiżviluppaw ‘inibituri' (antikorpi) kontra l-fattur VIII jew IX;
English: • acquired haemophilia (a bleeding disease caused by the development of inhibitors to factor VIII);
Maltese: • emofilja akkwiżita (marda tal-emorraġija kkawżata mill-iżvilupp ta' inibituri għall-fattur VIII);
English: The active substance in NovoSeven, eptacog alfa, is almost identical to a human protein called factor VII.
Maltese: Is-sustanza attiva f'NovoSeven, l-eptacog alfa, hija kważi identika għall-proteina umana bl-isem fattur VII. Eptacog alfa taħdem bl-istess mod bħal fattur VII. Fil-ġisem, il-fattur VII huwa involut filkoagulazzjoni.
English: • Glanzmann's thrombasthenia (a rare bleeding disorder) who cannot be treated with a transfusion of platelets (components that help the blood to clot).
Maltese: • trombastenija ta' Glanzmann (tip ta' disturb rari ta' emorraġija) li ma jkunux jistgħu jiġu kkurati bi trasfużjoni tal-pjastrini (komponenti li jgħinu fit-tagħqid tad-demm).
English: By activating factor X, NovoSeven is able to give temporary control of the bleeding disorder.
Maltese: Meta jattiva l-fattur X, NovoSeven ikun jista' jagħti kontroll temporanju għad-disturb tal-emorraġija.
English: As for all medicines, data on the use of NovoSeven are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' NovoSeven hija ssorveljata kontinwament.
English: What measures are being taken to ensure the safe and effective use of NovoSeven?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' NovoSeven?
English: Side effects reported with NovoSeven are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati b'NovoSeven huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Because factor VII acts directly on factor X, independently from factors VIII and IX, NovoSeven can be used in haemophilia patients who have developed inhibitors to factor VIII or IX.
Maltese: Minħabba li l-fattur VII jaġixxi direttament fuq il-fattur X, indipendentement mill-fatturi VIII u IX, NovoSeven jista' jintuża f'pazjenti b‘emofilja li jkunu żviluppaw inibituri għall-fattur VIII jew IX.
English: NovoSeven must not be used in people who are hypersensitive (allergic) to eptacog alfa, to mouse, hamster or cow proteins, or to any of the other ingredients.
Maltese: NovoSeven ma għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal eptacog alfa, għal proteini tal-ġrieden, tal-ħemsters jew tal-baqar jew għal xi ingredjent ieħor tiegħu.
English: NovoSeven is a medicine used to treat and to prevent bleeding after surgical procedures.
Maltese: NovoSeven huwa mediċina li tintuża biex tikkura u tipprevjeni l-emorraġija wara proċeduri kirurġiċi.
English: It is available as a powder and solvent that are made up into a solution to be injected into a vein.
Maltese: Jiġi bħala trab u solvent li jitħalltu biex isiru soluzzjoni li tiġi injettata fil-vina.
English: • In haemophilia, the dose is 90 micrograms per kilogram body weight, repeated every 2 to 3 hours until the bleeding is controlled.
Maltese: • Fl-emofilja, id-doża hija ta' 90 mikrogramma għal kull kilogramma ta' piż tal-ġisem, li għandha tiġi ripetuta kull sagħtejn jew tliet sigħat sakemm ma l-emorraġija tiġi kkontrollata.
English: Side effects with NovoSeven are not common.
Maltese: L-effetti sekondarji b'NovoSeven mhumiex komuni.
English: 1 After reconstitution, 1 dose (0.2 ml) contains:
Maltese: Wara r-rikostituzzjoni, doża 1 (0.2 ml) fiha:
English: B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 254977)
Maltese: Razza simili għal B/Phuket/3073/2013 (B/Phuket/3073/2013, MEDI 254977)
English: A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Switzerland/3330/2017, MEDI 307134)
Maltese: Razza simili għal A/Brisbane/02/2018 (H1N1)pdm09 (A/Switzerland/3330/2017, MEDI 307134)
English: B/Colorado/06/2017 - like strain (B/Colorado/06/2017, MEDI 293454)
Maltese: Razza simili għal B/Colorado/06/2017 (B/Colorado/06/2017, MEDI 293454)
English: A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, MEDI 308763)
Maltese: Razza simili għal A/Kansas/14/2017 (H3N2) (A/Kansas/14/2017, MEDI 308763)
English: Pack size sprayer (glass) in trays sprayer (glass) in a tri-fold carton
Maltese: Użu fl-imnieħer sprejer (ħġieġ) f'kartuna fi tliet lilwiet
English: fluorescent focus units
Maltese: Dan il-prodott fih organiżmi ġenetikament modifikati (OĠM). unitajiet b'fokus fluworexxenti
English: produced in VERO cells by reverse genetic technology.
Maltese: propagat f'bajd tat-tiġieġ fertilizzati minn qatgħat tat-tiġieġ b'saħħithom. prodotti f'ċelloli VERO b'teknoloġija ġenetika bil-maqlub.
English: 1 (live attenuated) of the following four strains
Maltese: Virus tal-influwenza riassortanti 1 (ħaj attenwat) tal-erba' razez li ġejjin
English: MA (EU) Number
Maltese: Numru tal-MA (EU) Isem Qawwa
English: The full EPAR for Flixabi 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: Results of this study showed that Flixabi was as effective as Remicade in reducing symptoms of rheumatoid arthritis: 64% of those treated with Flixabi (148 of 231 patients) had at least a 20% reduction in ACR scores, compared with 66% of those given Remicade (163 out of 247).
Maltese: Ir-riżultati ta' dan l-istudju wrew li Flixabi huwa effettiv daqs Remicade biex inaqqas is-sintomi tal-artrite rewmatika: 64% ta' dawk ikkurati bi Flixabi (148 minn 231 pazjent) laħqu mill-anqas tnaqqis ta' 20% fil-punteġġi ACR meta mqabbla ma' 66% ta' dawk li ngħataw Remicade (163 minn 247).
English: Flixabi is an anti-inflammatory medicine.
Maltese: Flixabi huwa mediċina antiinfjammatorja.
English: This is a summary of the European public assessment report (EPAR) for Flixabi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Flixabi.
English: Flixabi contains the active substance infliximab and is a ‘biosimilar medicine'.
Maltese: Flixabi fih is-sustanza attiva infliximab u huwa ‘mediċina bijosimili'.
English: Other information about Flixabi
Maltese: Informazzjoni oħra dwar Flixabi
English: The reference medicine for Flixabi is Remicade.
Maltese: Il-mediċina ta' referenza għal Flixabi hija Remicade.
English: The active substance in Flixabi, infliximab, is a monoclonal antibody (a type of protein) that has been designed to attach to a protein called tumour necrosis factor-alpha (TNF-alpha) and block its activity.
Maltese: Is-sustanza attiva fi Flixabi, l-infliximab, hija antikorp monoklonali (tip ta' proteina) li ġiet imfassla sabiex teħel ma proteina li tissejjaħ fattur tan-nekrosi tat-tumur alpha (TNF-alpha) u timblokka lattività tagħha.
English: The most common side effects with Flixabi (seen in more than 1 patient in 10) are viral infections (such as flu or cold sores), headache, upper-respiratory-tract infection (colds), sinusitis (inflammation of the sinuses), nausea (feeling sick), abdominal pain (stomach ache), infusion-related reactions and pain.
Maltese: L-effetti sekondarji l-aktar komuni bi Flixabi (li dehru f'aktar minn pazjent wieħed minn kull 10) huma infezzjonijiet virali (bħall-influwenza u ponot tal-irjiħat), uġigħ ta' ras, infezzjoni fin-naħa ta' fuq talapparat respiratorju (irjiħat), sinusite (infjammazzjoni tas-sinus), nawżja (tħossok ma tiflaħx), uġigħ addominali (uġigħ ta' stonku), reazzjonijiet relatati mal-infużjoni u uġigħ.
English: Flixabi is used with methotrexate (a medicine that acts on the immune system);
Maltese: Flixabi jintuża ma' methotrexate (mediċina li taħdem fuq is-sistema immunitarja);
English: Studies were carried out to show that Flixabi is comparable to Remicade, including a study to show that it produces similar levels of the active substance in the body to Remicade.
Maltese: Twettqu studji sabiex juru li Flixabi huwa komparabbli ma' Remicade, inkluż studju li juri li jipproduċi livelli simili tas-sustanza attiva fil-ġisem għal Remicade.
English: Why is Flixabi approved?
Maltese: Għaliex ġie approvat Flixabi?
English: Flixabi was also compared with Remicade in one main study involving 584 patients with moderate to severe rheumatoid arthritis who had received previous treatment with methotrexate.
Maltese: Flixabi tqabbel ukoll ma' Remicade fi studju wieħed ewlieni li involva 584 pazjent b'artrite rewmatika moderata sa severa li qabel kienu rċevew kura b'methotrexate.
English: • Crohn's disease (a disease causing inflammation of the gut), when the disease is moderate to severe or causes fistulae (abnormal passageways between the gut and other organs);
Maltese: • il-marda ta' Crohn (marda li tikkawża infjammazzjoni tal-musrana diġestiva), meta l-marda tkun moderata sa severa jew fistulanti (passaġġi anormali bejn l-imsaren u organi oħrajn);
English: What are the risks associated with Flixabi?
Maltese: X'inhuma r-riskji assoċjati ma' Flixabi?
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar ilmediċini bijosimili, ara d-dokument ta' mistoqsija u tweġiba hawn.
English: This means that Flixabi is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Flixabi hu simili għal mediċina bijoloġika (magħrufa wkoll bħala ‘l-mediċina ta' referenza') li diġà hi awtorizzata fl-Unjoni Ewropea (UE).
English: The main measure of effectiveness was the proportion of patients who achieved at least a 20% reduction in ACR scores (a measure of painful, swollen joints and other symptoms) after 30 weeks of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien innumru ta' pazjenti li kellhom mill-inqas tnaqqis ta' 20% fil-punteġġi ACR (kejl tal-ġogi li jikkawżaw luġigħ u li huma minfuħin u sintomi oħrajn) wara 30 ġimgħa ta' kura.
English: Flixabi is usually given as 3 mg per kilogram body weight in rheumatoid arthritis, although the dose can be increased if necessary.
Maltese: Flixabi ġeneralment jingħata bħala 3 mg għal kull kilogramm tal-piż tal-ġisem fl-artrite rewmatodje, għalkemm id-doża tista' tiżdied jekk ikun meħtieġ.
English: Flixabi is also used in patients aged between 6 and 17 years with severe Crohn's disease or ulcerative colitis, when they have not responded to or cannot take other medicines or treatments.
Maltese: Flixabi jintuża wkoll f'pazjenti ta' bejn 6 u 17-il sena bil-marda ta' Crohn severa jew kolite ulċerattiva attiva gravi, meta ma jkunux irrispondew għal jew ma jkunux jistgħu jieħdu mediċini jew kuri oħrajn.
English: By blocking TNF-alpha, infliximab improves the inflammation and other symptoms of these diseases.
Maltese: Bl-imblukkar tat-TNF-alpha, l-infliximab itaffi l-infjammazzjoni u s-sintomi l-oħrajn ta' dan il-mard.
English: TNF-alpha is involved in causing inflammation and is found at high levels in patients with the diseases that Flixabi is used to treat.
Maltese: It-TNF-alpha huwa involut fil-kawża tal-infjammazzjoni u jinsab f'livelli għoljin f'pazjenti li jkollhom mard li normalment jiġi kkurat bi Flixabi.
English: A risk management plan has been developed to ensure that Flixabi is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Flixabi jintuża bl-aktar mod sigur possibbli.
English: For further information see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Flixabi has been shown to have a comparable quality, safety and effectiveness to Remicade.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li Flixabi intwera li għandu profil ta' kwalità, sigurtà u effikaċja komparabbli ma' Remicade.
English: In particular, information will be provided for doctors who intend to prescribe the medicine to children with Crohn's disease or ulcerative colitis, to explain that these patients may be at an increased risk of developing infections and to remind of the importance of keeping vaccinations up to date.
Maltese: Dan jintuża fl-adulti, ġeneralment meta mediċini jew kuri oħrajn ikunu fallew jew ma jistgħux jintużaw, għall-kura tal-mard li ġej:
English: How does Flixabi work?
Maltese: Kif jintuża Flixabi?
English: What measures are being taken to ensure the safe and effective use of Flixabi?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Flixabi?
English: It may harm them,
Maltese: Insuffiċjenza tal qalb,
English: b OR=Odds Ratio.
Maltese: b OR=Proporzjon Odds.
English: This may take about 10 minutes.
Maltese: Dan jista'jieħu sa' 10 minuti.
English: Patients with documented RET mutation (n=187)
Maltese: Pazjenti b'mutazzjoni RET dokumentata (n=187)
English: N=Number of events/number of randomised patients
Maltese: N=Numru ta' episodji/ numru ta' pazjenti randomised;
English: 7 day schedule:
Maltese: Skeda ta' 7 ijiem:
English: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Maltese: Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, L-Irlanda
English: • Malnutrition.
Maltese: • Malnutrizzjoni.
English: This is seen on an electrocardiogram (ECG).
Maltese: Dan jidher minn elettrokardjogramma (ECG ).
English: Alanine aminotransferase elevations
Maltese: Żiediet tal-alanine aminotransferase
English: Efficacy endpoint PFS HR (95%) confidence interval
Maltese: Fini dwar l-effikaċja PFS HR (95%) intervall tal-konfidenza
English: Only patients with CTN ≥ 500 pg/mL (conventional units) or ≥ 146.3 pmol/L (international standard units) were enrolled.
Maltese: ≥ 500 pg/mL biss (unitajiet konvenzjonali) jew ≥ 146.3 pmol/L (unitajiet internazzjonali standard)
English: 37 Hollands Road Haverhill Suffolk, CB9 8PU United Kingdom
Maltese: 37 Hollands Road Haverhill Suffolk, CB9 8PU Ir-Renju Unit
English: Bullous dermatitis
Maltese: Dermatite bulluż
English: Vandetanib is an inhibitor of the organic cation 2 (OCT2) transporter.
Maltese: Vandetanib huwa inibitur tat-trasportatur tal-cation organiku 2 (OCT2).
English: 200 daily
Maltese: 200 kuljum
English: Figure 1: Kaplan Meier plot of PFS
Maltese: Plott Kaplan Meier tal-PFS
English: Table 2: Adverse reactions and system organ class System Organ
Maltese: Tabella 2: Reazzjonijiet avversi u l-klassi tas-sistema tal-organi Klassi tas
English: AstraZeneca UK Limited, Macclesfield, Cheshire, SK10 2NA, United Kingdom Or
Maltese: AstraZeneca UK Limited, Macclesfield, Cheshire, SK10 2NA, Ir-Renju Unit Jew
English: Respiratory failure, pneumonia aspiration
Maltese: Insuffiċjenza respiratorja, aspirazzjoni filpulmun
English: Dose reduction (mg) c
Maltese: Tnaqqis fid-doża (mg) c
English: Silk Road Business Park Macclesfield, Cheshire SK10 2NA United Kingdom
Maltese: Silk Road Business Park Macclesfield, Cheshire SK10 2NA Ir-Renju Unit
English: Patients with no M918T mutation and other mutations not tested or negative (n=79)*
Maltese: Pazjenti mingħajr mutazzjoni M918T u mutazzjonijiet oħra mhux testjati jew negattivi (n=79)*
English: • itraconazole, ketoconazole, ritonavir, clarithromycin, rifampicin and moxifloxacin (medicines used to treat infections)
Maltese: • itraconazole, ketoconazole, ritonavir, clarithromycin, rifampicin u moxifloxicine (mediċini li jintużaw għall-kura ta' infezzjonijiet)
English: Median PFS HR 95% CI p-value
Maltese: HR 95% CI Valur-p
English: Insomnia, Depression
Maltese: Insomnja, dipressjoni
English: • Toxins in the blood as a complication of infection.
Maltese: • Toxins fid-demm bħala komplikazzjoni ta' infezzjoni.
English: QTcF prolongation was > 20 ms in over 91% of patients, > 60 ms in 35%, > 100 ms in 1.7%.
Maltese: It-titwil tal-QTcF kien > 20 ms f'aktar minn 91% tal-pazjenti, > 60 ms f'35%, > 100 ms f'1.7%.
English: Malnutrition
Maltese: Malnutrizzjoni