FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for DuoPlavin 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: Other information about DuoPlavin:
Maltese: Informazzjoni oħra dwar DuoPlavin:
English: The European Commission granted a marketing authorisation valid throughout the EU for DuoPlavin on 15 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal DuoPlavin fil15 ta' Marzu 2010.
English: DuoPlavin clopidogrel / acetylsalicylic acid
Maltese: DuoPlavin klopidogrel / aċidu aċetilsaliċiliku
English: It is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid.
Maltese: Jiġi f'pilloli li jkun fihom 75 mg klopidogrel, flimkien ma', jew 75 mg jew 100 mg ta' aċidu aċetilsaliċiliku.
English: The most common side effects with DuoPlavin (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising, and bleeding where the skin is punctured.
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' DuoPlavin (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma ematoma (ġmiegħ ta' demm taħt il-ġilda), epistassi (fġir tal-imnieħer), emorraġija gastrointestinali (ħruġ ta' demm fiż-żaqq jew fil-musrana), dijarrea, uġigħ addominali (uġigħ flistonku), dispepsija (indiġestjoni), tbenġil u ħruġ ta' demm minn fejn il-ġilda tkun ittaqqbet.
English: This document is a summary of the European Public Assessment Report (EPAR) for DuoPlavin.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal DuoPlavin.
English: What is DuoPlavin?
Maltese: X'inhu DuoPlavin?
English: Why has DuoPlavin been approved?
Maltese: Għaliex ġie approvat DuoPlavin?
English: The CHMP noted that DuoPlavin is comparable to clopidogrel and acetylsalicylic acid tablets taken separately, and concluded that combining both active substances in a single DuoPlavin tablet simplifies treatment for patients as they will need to take fewer tablets.
Maltese: Is-CHMP irrimarka li DuoPlavin huwa kumparabbli mal-pilloli tal-klopidogrel u tal-aċidu aċetilsaliċiliku meħuda b'mod separat, u kkonkluda li l-kombinazzjoni taż-żewġ sustanzi flimkien f'pillola waħda ta' DuoPlavin tissimplifika l-kura għall-pazjenti peress li jkollhom jieħdu inqas pilloli.
English: DuoPlavin is a medicine that contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin).
Maltese: DuoPlavin huwa mediċina li fiha żewġ sustanzi attivi, il-klopidogrel u l-aċidu aċetilsaliċiliku (magħruf ukoll bħala aspirina).
English: • patients who have ‘unstable angina' (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on the ECG or electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Maltese: • pazjenti li jkollhom anġina instabbli (tip ta' wġigħ sever fis-sider) jew kellhom attakk tal-qalb b'ebda ‘elevazzjoni tas-segment ST' (qari anormali fuq l-ECG jew elettrokardjogramma), inklużi dawk li qegħdin ikollhom stent (tubu qasir) inserit fl-arterja biex jipprevjeniha milli tagħlaq;
English: DuoPlavin must not be used in people who are hypersensitive (allergic) to clopidogrel, non steroidal anti-inflammatory drugs (such as acetylsalicylic acid) or any of the other ingredients in DuoPlavin.
Maltese: DuoPlavin ma għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għall-klopidogrel, għal mediċini antiinfjammatorji mhux steroidi (bħall-aċidu aċetilsaliċiliku) jew għal kwalunkwe ingredjent ieħor ta' DuoPlavin.
English: Clopidogrel has been authorised since 1998 for reducing platelet aggregation, and is often used in combination with acetylsalicylic acid.
Maltese: Il-klopidogrel ilu awtorizzat mill-1998 għat-tnaqqis ta' aggregazzjoni tal-pjastrini, u ta' spiss jintuża f'kombinazzjoni mal-aċidu aċetilsaliċiliku.
English: How has DuoPlavin been studied?
Maltese: Kif ġie studjat DuoPlavin?
English: Both active substances in DuoPlavin, clopidogrel and acetylsalicylic acid, are antiplatelet medicines.
Maltese: Iż-żewġ sustanzi attivi f'DuoPlavin, il-klopidogrel u l-aċidu aċetilsaliċiliku, huma mediċini antipjastrini.
English: DuoPlavin is used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Maltese: DuoPlavin jintuża biex jipprevjeni problemi kkawżati minn emboli tad-demm u minn twebbis tal-arterji bħall-attakki tal-qalb, f'adulti li jkunu diġà qegħdin jieħdu kemm il-klopidogrel kif ukoll l-aċidu aċetilsaliċiliku bħala pilloli separati.
English: Acetylsalicylic acid has been available for over 100 years.
Maltese: L-aċidu aċetilsaliċiliku ilu disponibbli iktar minn 100 sena.
English: For the full list of all side effects reported with DuoPlavin, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'DuoPlavin, ara l-fuljett ta' tagħrif.
English: What is the risk associated with DuoPlavin?
Maltese: X'inhu r-riskju assoċjat ma' DuoPlavin?
English: How does DuoPlavin work?
Maltese: Għal xiex jintuża DuoPlavin?
English: Pelmeg is a ‘biosimilar medicine'.
Maltese: Pelmeg huwa "mediċina bijosimili".
English: Further information on Pelmeg can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pelmeg.
Maltese: ema.europa.eu/medicines/human/EPAR/pelmeg.
English: Pelmeg (pegfilgrastim) EMA/653835/2018
Maltese: EMA/786639/2018
English: Other information about Pelmeg
Maltese: Informazzjoni oħra dwar Pelmeg
English: The active substance in Pelmeg, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Pelmeg, il-pegfilgrastim, hija forma ta' filgrastim, li hija simili ħafna għal proteina tal-bniedem imsejħa fattur stimolanti tal-kolonja tal-granuloċiti (G-CSF).
English: Laboratory studies comparing Pelmeg with Neulasta have shown that the active substance in Pelmeg is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Pelmeg ma' Neulasta wrew li s-sustanza attiva f'Pelmeg hija simili ħafna għal dik f'Neulasta f'termini ta' struttura, purità u attività bijoloġika.
English: The reference medicine for Pelmeg is Neulasta.
Maltese: Il-mediċina ta' referenza għal Pelmeg hija Neulasta.
English: What are the risks associated with Pelmeg?
Maltese: X'inhuma r-riskji assoċjati ma' Pelmeg?
English: Pelmeg is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Maltese: Pelmeg jingħata bħala doża waħda ta' 6 mg li tiġi injettata taħt il-ġilda mill-inqas 24 siegħa wara t-tmiem ta' kull ċiklu ta' kimoterapija (kura b'mediċini tal-kanċer).
English: In Pelmeg, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'Pelmeg, filgrastim ġie “pegilat” (twaħħal ma' kimika msejħa polietilenglikol).
English: How is Pelmeg used?
Maltese: Kif jaħdem Pelmeg?
English: All these data were considered sufficient to conclude that Pelmeg will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Pelmeg ser jaġixxi bl-istess mod bħal Neulasta f'termini ta' effettività u sigurtà fl-użu approvat tiegħu.
English: Pelmeg is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Maltese: Pelmeg mhuwiex maħsub biex jintuża f'pazjenti bil-lewkimja majelojde kronika tal-kanċer tad-demm jew b'sindromi majelodisplastiċi (kundizzjonijiet li fihom jiġu prodotti għadd kbir ta' ċelloli tad-demm anormali, li jistgħu jiżviluppaw f'lewkimja).
English: As for all medicines, data on the use of Pelmeg are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Pelmeg hija ssorveljata kontinwament.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelmeg has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Pelmeg għandu struttura, purità u attività bijoloġika simili ħafna għal Neulasta u jiġi distribwit bl-istess mod fil-ġisem.
English: This means that Pelmeg is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Pelmeg huwa simili ħafna għal mediċina bijoloġika oħra (il-"mediċina ta' referenza") li diġà hija awtorizzata fl-UE.
English: For the full list of side effects and restrictions with Pelmeg, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet irrappurtati b'Pelmeg, ara l-fuljett ta' tagħrif.
English: Pelmeg is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Maltese: Pelmeg huwa mediċina li tintuża f'pazjenti bil-kanċer biex tgħin fin-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), li hija effett sekondarju komuni tal-kura tal-kanċer u tista' twassal biex il-pazjenti jsiru vulnerabbli għall-infezzjonijiet.
English: Filgrastim works by encouraging the
Maltese: Filgrastim jaħdem billi
English: Side effects reported with Pelmeg are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Pelmeg huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The safety of Pelmeg has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Maltese: Is-sigurtà ta' Pelmeg ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza Neulasta.
English: What measures are being taken to ensure the safe and effective use of Pelmeg?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Pelmeg?
English: System organ class Preferred term
Maltese: Sistema ta' klassifika tal-organi Terminu ppreferut
English: Bradycardia a
Maltese: Bradikardija a
English: Bradycardia c
Maltese: Bradikardija c
English: D-90429 Nuremberg Germany
Maltese: D90429 Nürnberg Il-Ġermanja
English: Estimated using the Kaplan-Meier method.
Maltese: Stmat permezz tal-metodu Kaplan-Meier.
English: Based on the stratified log-rank test.
Maltese: Abbażi tat-test tal-log-rank stratifikat.
English: 92.1% of patients had adenocarcinoma.
Maltese: 92.1% tal-pazjenti kellhom adenokarċinoma.
English: Film-coating: hypromellose; titanium dioxide (E171); macrogol; talc; indigo carmine aluminium lake (E132).
Maltese: Rita: hypromellose; titanium dioxide (E171); macrogol; talc; indigo carmine aluminium lake (E132).
English: Bradycardia (bradycardia, sinus bradycardia)
Maltese: Bradikardija (bradikardija, bradikardija tas-sinus)
English: (symptomatic, may be severe and medically significant, medical intervention indicated)
Maltese: (sintomatika, tista' tkun gravi u sinjifikanti medikament, intervent mediku indikat)
English: Overall Response Rate (ORR: CR+PR), n (%) (95% CI)
Maltese: Rata ta' Rispons Globali (ORR: CR+PR), n (%) (95% CI)
English: Study A2201 ceritinib 750 mg
Maltese: Studju A2201 ceritinib 750 mg
English: Date of first authorisation: 06 May 2015 Date of latest renewal: 22 March 2017
Maltese: Data tal-aħħar tiġdid: 22 ta' Marzu 2017
English: Approximate diameter: 9.1 mm.
Maltese: Dijametru ta' madwar: 9.1 mm.
English: 150 (3 packs of 50) hard capsules.
Maltese: 150 (3 pakketti ta' 50) kapsula iebsa.
English: Hazard Ratio = 0.55
Maltese: Proporzjon ta' Periklu = 0.55
English: Dose optimisation Study A2112 (ASCEND-8)
Maltese: Studju ta' ottimizzazzjoni tad-doża A2112 (ASCEND-8)
English: Log rank p-value = 0.496
Maltese: Valur-p tal-logrank = 0.496
English: Amylase increased
Maltese: Żieda ta' amylase
English: Study X2101 ceritinib 750 mg
Maltese: Studju X2101 ceritinib 750 mg
English: It may harm them,
Maltese: Dan hu trattament li jieħu fit-tul, possibbilment jaf idum ix-xhur.
English: Tabulated list of ADRs
Maltese: Lista ttabulata tal-ADRs
English: The active substance of Zykadia is ceritinib.
Maltese: Is-sustanza attiva ta' Zykadia hi ceritinib.
English: Effects of age, gender, and race
Maltese: L-effetti tal-età, is-sess, u r-razza
English: Rash (rash, dermatitis acneiform, rash maculopapular)
Maltese: Raxx (raxx, dermatite akneiformi, raxx makulopapulari)
English: Overall survival c
Maltese: Sopravivenza globali c
English: ADRs are listed according to MedDRA system organ class.
Maltese: L-ADRs qed jitniżżlu skond is-sistema ta' klassifika tal-organi MEDRA.
English: Printing ink: Shellac (bleached, de-waxed) glaze 45%, iron oxide black (E172), propylene glycol and ammonium hydroxide 28%.
Maltese: Shellac (bleached, de-waxed) glaze 45%, iron oxide black (E172), propylene glycol u ammonium hydroxide 28%.
English: 1% of patients required permanent discontinuation of treatment in clinical studies with ceritinib (see sections 4.2 and 4.4).
Maltese: 1% tal-pazjenti kienu jeħtieġu twaqqif permanenti tat-trattament fi studji kliniċi b'ceritinib (ara sezzjonijiet 4.2 u 4.4).
English: Gastrointestinal events were managed primarily with concomitant medicinal products including anti-emetic/anti-diarrhoeal medicinal products.
Maltese: L-avvenimenti gastrointestinali kienu mmaniġġjati primarjament bi prodotti mediċinali konkomitanti, inklużi prodotti mediċinali antiemetiċi / antidijarreali.
English: Capsule shell: gelatin, indigotine (E132) and titanium dioxide (E171).
Maltese: Qafas tal-kapsula: gelatin, indigotine (E132) u titanium dioxide (E171).
English: You may need to read it again.
Maltese: Waqqaf kompletament f'każ ta' rikorrenza.
English: 50 hard capsules.
Maltese: 50 kapsula iebsa.
English: Based on in vitro data, ceritinib does not inhibit apical efflux transporter MRP2, hepatic uptake transporters OATP1B1 or OATP1B3, renal organic anion uptake transporters OAT1 and OAT3, or the organic cation uptake transporters OCT1 or OCT2 at clinically relevant concentrations.
Maltese: Skont dejta in vitro, ceritinib ma jinibixxix it-trasportatur tal-effluss apikali MRP2, it-trasportaturi ta' adozzjoni epatika OATP1B1 jew OATP1B3, it-trasportaturi ta' adozzjoni tal-anjoni organiku renali OAT1 u OAT3, jew it-trasportaturi ta' adozzjoni tal-kazzjoni organika OCT1 jew OCT2 f'konċentrazzjonijiet relevanti b'mod kliniku.
English: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation >5 times upper limit of normal (ULN) with concurrent total bilirubin ≤2 times ULN
Maltese: Żieda ta' alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) b'>5 darbiet l-ogħla limitu tan-normal (ULN) bit-total tal-bilirubin b'mod konkomitanti ≤darbtejn l-ULN
English: Capsule contents: silica, colloidal anhydrous; hydroxypropylcellulose, low-substituted; sodium starch glycolate (type A); magnesium stearate; cellulose, microcrystalline.
Maltese: Kontenuti tal-kapsula: silica, colloidal anhydrous; hydroxypropylcellulose, lowsubstituted sodium starch glycolate (type A); magnesium stearate; cellulose, microcrystalline.
English: CYP2A6 and CYP2E1 substrates
Maltese: Sottostrati ta' CYP2A6 u CYP2E1
English: Hazard Ratio = 0.73 95% CI (0.50, 1.08)
Maltese: Proporzjon ta' Periklu = 0.73 95% CI (0.50, 1.08)
English: Elderly (≥65 years)
Maltese: Pazjenti anzjani (≥65 sena)
English: Vision disorder (vision impairment, vision blurred, photopsia, vitreous floaters, visual acuity reduced, accommodation disorder, presbyopia)
Maltese: Disturb fil-vista (indeboliment fil-vista, vista mċajpra, fotopsija, vitreous floaters, tnaqqis fiċ-ċarezza tal-vista, disturb fl-akkomodazzjoni, presbijopija)
English: Medical treatment may be necessary.
Maltese: Jista' jkun hemm bżonn trattament mediku.
English: Based on in vitro data, ceritinib is a substrate of the efflux transporter P-glycoprotein (P-gp).
Maltese: Skont dejta in vitro, ceritinib hu sottostrat tat-trasportatur tal-effluss P-glikoproteina (P-gp).
English: Hazard Ratio = 1.00 95% CI (0.67;1.49)
Maltese: Proporzjon ta' riskju = 1.00 95% CI (0.67;1.49)
English: Pharmacotherapeutic group: antineoplasic and immunomodulating agents, ATC code: L01XE28.
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi u immunomodulatorji, Kodiċi ATC:
English: Single arm studies X2101 and A2201
Maltese: Studji fost grupp wieħed X2101 u A2201
English: Renal impairment (azotaemia, renal impairment)
Maltese: Indeboliment renali (azotemija, indeboliment renali)
English: CYP3A and CYP2C9 substrates
Maltese: Sottostrati ta' CYP3A u CYP2C9
English: Chemotherapy (N=116)
Maltese: Kimoterapija (N=116)
English: Secondary biotransformation pathways involving the primary biotransformation products included glucuronidation and dehydrogenation.
Maltese: Mogħdijiet sekondarji ta' bijotrasformazzjoni li jinvolvu prodotti primarji ta' bijotrasformazzjoni inkludew glucuronidation u dehydrogenation.
English: Gastrointestinal disorders Diarrhoea e
Maltese: Disturbi gastrointestinali Dijarrea e
English: Packs containing 40, 90 or 150 (3 packs of 50) hard capsules.
Maltese: Pakketti li fihom 40, 90 jew 150 (3 pakketti ta' 50) kapsula iebsa.
English: Ceritinib 750 mg 115 87 68 40 31 18 12 9 Chemotherapy
Maltese: Ceritinib 750 mg 115 87 68 40 31 18 12 9 Kimoterapija
English: Heart rate less than 60 beats per minutes (bpm)
Maltese: Rata tal-qalb ta' anqas minn 60 taħbita l-minuta (bpm)
English: a p-value b
Maltese: a valur-p b
English: Number of events, n (%) Median, months d
Maltese: Numru ta' avvenimenti, n (%) Medjan, xhur d
English: Hypophosphataemia
Maltese: Ipofosfatemija
English: Respiratory, thoracic and mediastinal disorders Pneumonitis d
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Pulmonite d
English: Agents that are substrates of transporters
Maltese: Aġenti li huma sottostrati ta' trasportaturi
English: Renal and urinary disorders Renal failure k
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Insuffiċjenza renali k
English: The micronucleus test in TK6 cells was positive.
Maltese: It-test mikronukleu fiċ-ċelluli TK6 kien pożittiv.
English: Patients with severe renal impairment (CLcr <30 ml/min) were not included in the clinical studies of Zykadia (see section 4.2).
Maltese: Pazjenti b'indeboliment renali gravi (CLcr <30 ml/min) ma kenux inklużi fl-istudji kliniċi ta' Zykadia (ara sezzjoni 4.2).
English: The other ingredients are: Tablet core: cellulose, microcrystalline; hydroxypropylcellulose, low-substituted; povidone; croscarmellose sodium; magnesium stearate; silica, colloidal anhydrous.
Maltese: Qalba tal-pillola: cellulose, microcrystalline; hydroxypropylcellulose, low-substituted; povidone; croscarmellose sodium; magnesium stearate; silica, colloidal anhydrous.
English: ceritinib 750 mg 189 180 175 171 165 155 150 138 103 77 56 39 26 18 6 3 2 0 Chemotherapy 187 172 161 150 146 141 134 124 97 69 49 35 19 10 5 1 0 0
Maltese: ceritinib 750 mg 189 180 175 171 165 155 150 138 103 77 56 39 26 18 6 3 2 0 Kimoterapija 187 172 161 150 146 141 134 124 97 69 49 35 19 10 5 1 0 0
English: Final overall survival (OS) data are presented for Study A2201.
Maltese: Id-dejta dwar issopravivenza globali (OS) finali hija ppreżentata għal Studju A2201.
English: Seventy-three (73) patients received docetaxel and 40 received pemetrexed.
Maltese: Tlieta u sebgħin (73) pazjent ingħataw docetaxel u 40 ingħataw pemetrexed.
English: In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each ADR: 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); and not known (cannot be estimated from the available data).
Maltese: Barra minn hekk, qed tingħata wkoll il-kategorija bil-frekwenza korrispondenti bili qed tintuża lkonvenzjoni li ġejja (CIOMS III) għal kull ADR: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa 1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000); u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Chemotherapy (N=187)
Maltese: Kimoterapija (N=187)
English: QT corrected for heart rate (QTc) >500 msec on at least 2 separate electrocardiograms (ECGs)
Maltese: QT ikkoreġut għar-rata tal-qalb (QTc) >500 msek f'mill-inqas żewġ elettrokardjogrammi separati (ECGs)
English: Oesophageal disorder g
Maltese: Disturb esofagali g
English: Kaplan-Meier medians (95% CI) (Months) ceritinib 750 mg: NE (29.3, NE) Chemotherapy: 26.2 (22.8, NE) Logrank p-value = 0.056
Maltese: Medjani Kaplan-Meier (95% CI) (Xhur) ceritinib 750 mg: NE (29.3, NE) Kimoterapija: 26.2 (22.8, NE) Valur-p tal-logrank = 0.056
English: 40 hard capsules 90 hard capsules
Maltese: 40 kapsula iebsa 90 kapsula iebsa
English: P-gp inhibitors
Maltese: Inibituri P-gp
English: One hundred and five (105) patients out of the 145 patients (72.4%) that discontinued treatment in the chemotherapy arm received subsequent ALK inhibitor as first antineoplastic therapy.
Maltese: Mija u ħames (105) pazjenti minn 145 pazjent (72.4%) li waqqfu t-trattament fil-grupp talkimoterapija ngħataw inibitur ALK sussegwenti bħala l-ewwel terapija antineoplastika.
English: The capsules are provided in blisters and are available in packs containing 40, 90 or 150 (3 packs of 50) capsules.
Maltese: Il-kapsuli jiġu f'folji u huma disponibbli f'pakketti li fihom 40, 90 jew 150 (3 pakketti ta' 50) kapsula.
English: Based on the stratified Cox proportional hazards analysis.
Maltese: Abbażi tal-analiżi stratifikata tal-perikli proporzjonali Cox.
English: Kaplan-Meier medians (95% CI) (Months) Ceritinib 750 mg: 18.1 (13.4;23.9) Chemotherapy: 20.1 (11.9;25.1)
Maltese: Medjani Kaplan-Meier (95% CI) (Xhur) Ceritinib 750 mg: 18.1 (13.4;23.9) Kimoterapija: 20.1 (11.9;25.1)
English: Ceritinib 750 mg fasted (N=40)
Maltese: Ceritinib 750 mg fi stat sajjem (N=40)
English: The maximum allowable dose under fasted condition is 750 mg (see section 5.2).
Maltese: Id-doża massima permessa f'kondizzjoni ta' sawm hija ta' 750 mg (ara sezzjoni 5.2).
English: Ceritinib 450 mg with food (N=41)
Maltese: Ceritinib 450 mg mal-ikel (N=41)
English: HR=hazard ratio; CI=confidence interval; BIRC=Blinded Independent Review Committee; NE=not estimable a
Maltese: HR=proporzjon ta' periklu; CI=intervall ta' kunfidenza; BIRC=Kumitat għal Analiżi Indipendenti mhux Ippreġudikata;
English: A grade 3 event of diarrhoea was reported in one patient (1.1%).
Maltese: Kien irrapportat avveniment fil-grad 3 ta' dijarrea f'pazjent wieħed (1.1 %).
English: Duration of follow-up Median (months) (min - max) Overall response rate Investigator (95% CI) BIRC (95% CI) Duration of response* Investigator (months, 95% CI) BIRC (months, 95% CI) Progression-free survival Investigator (months, 95% CI) BIRC (months, 95% CI) Overall survival (months, 95% CI)
Maltese: Investigatur (95% CI) BIRC (95% CI) It-tul tar-rispons* Investigatur (xhur, 95% CI) BIRC (xhur, 95% CI) Sopravivenza ħielsa minn progressjoni Investigatur (xhur, 95% CI) BIRC (xhur, 95% CI) Sopravivenza globali (xhur, 95% CI)
English: PVC/PCTFE (polyvinylchloride/polychlorotrifluoroethylene) - Aluminium blisters containing 10 hard capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih PVC/PCTFE (polyvinylchloride/poliklorotriflworotilena) - Folji tal-aluminju li fihom 10 kapsuli iebsa.