FrancophonIA/ELRC3.0 huggingface dataset:
English: Ingestion of vortioxetine in clinical trials in the dose range of 40 mg to 75 mg has caused an aggravation of the following adverse reactions: nausea, postural dizziness, diarrhoea, abdominal discomfort, generalised pruritus, somnolence and flushing.
Maltese: It-teħid mill-ħalq ta' vortioxetine fi provi kliniċi f'marġni ta' dożi bejn 40 mg sa 75 mg ikkawża laggravar tar-reazzjonijiet avversi li ġejjin: dardir, sturdament posturali, dijarea, skonfort addominali, ħakk ġeneralizzat, ngħas u fwawar.
English: Brintellix 10 mg film-coated tablets Blister: Transparent; PVC/PVdC/aluminium blister.
Maltese: Trasparenti; folja magħmula minn PVC/PVdC/aluminju.
English: The effect seen with vortioxetine was a 4.7 point difference to placebo in MADRS total score at Week 8 (MMRM analysis).
Maltese: L-effett li deher b'vortioxetine kien ta' 4.7 punti ta' differenza mill-plaċebo fil-punteġġ totali MADRS fit8 ġimgħa (analiżi
English: Vortioxetine-related material was distributed to the milk of lactating rats (see section 4.6).
Maltese: vortioxetine (ara sezzjoni 4.5).
English: Contains ethanol
Maltese: Fih l-etanol
English: Brintellix 15 mg film-coated tablets EU/1/13/891/018-026
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/891/036
English: Red, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “20” on the other side.
Maltese: Pillola miksija b'rita ta' lewn aħmar, forma ta' lewża (5 x 8.4 mm) imnaqqxa b'“TL” fuq naħa waħda u “20” fuq in-naħa l-oħra.
English: Each film-coated tablet contains 15 mg vortioxetine (as hydrobromide).
Maltese: Kull pillola miksija b'rita fiha 15 mg vortioxetine (bħala hydrobromide).
English: Orange, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with “TL” on one side and “15” on the other side.
Maltese: Pillola miksija b'rita ta' lewn oranġjo, forma ta' lewża (5 x 8.4 mm) imnaqqxa b'“TL” fuq naħa waħda u “15” fuq in-naħa l-oħra.
English: Vortioxetine was not teratogenic in rats or rabbits, but reproductive toxicity in terms of effects on foetal weight and delayed ossification were seen in the rat at exposures more than 10-fold the human exposure at the maximum recommended therapeutic dose of 20 mg/day.
Maltese: Vortioxetine ma kienx teratoġeniku fil-firien jew fil fniek iżda tossiċità riproduttiva fis-sens ta' effetti fuq il-piż tal-fetu u fid-dewmien fl-ossifikazzjonidehru fil-far f'espożizzjonijiet li kienu 10 darbiet l-espożizzjoni umana fl-ogħla doża terapewtika rrakkomandata ta' 20 mg/jum.
English: In one study, vortioxetine was superior to placebo on subjective measures, evaluated using the Perceived Deficits Questionnaire with results of -14.6 for vortioxetine and -10.5 for placebo (p=0.002).
Maltese: F'wieħed mill-istudji, vortioxetine kien superjuri għall-plaċebo fuq miżuri suġġettivi, evalwat bl-użu tal- Kwestjonarju dwar Nuqqasijiet Innotati (Perceived Deficits Questionnaire) b'riżultati ta' -14.6 għal vortioxetine u -10.5 għall-plaċebo (p=0.002).
English: Each film-coated tablet contains 5 mg vortioxetine (as hydrobromide)
Maltese: Kull pillola miksija b'rita fiha 5 mg vortioxetine (bħala hydrobromide)
English: Each film-coated tablet contains 15 mg vortioxetine (as hydrobromide)
Maltese: Kull pillola miksija b'rita fiha 15 mg vortioxetine (bħala hydrobromide)
English: These symptoms could be due to either discontinuation effects or excess serotonergic activity.
Maltese: Dawn is-sintomi jistgħu jkunu kkawżati mill-effetti ta' twaqqif jew minn attività serotonerġika eċċessiva.
English: In severely depressed patients (baseline MADRS total score ≥30) and in depressed patients with a high level of anxiety symptoms (baseline HAM-A total score ≥20) vortioxetine also demonstrated efficacy in the short-term studies in adults (the overall mean difference to placebo in MADRS total score at Week 6/8 ranged from 2.8 to 7.3 points and from 3.6 to 7.3 points, respectively, (MMRM analysis)).
Maltese: MADRS fis-6/8 Ġimgħa kienet tvarja minn 2.8 sa 7.3 punti u minn 3.6 sa 7.3 punti, rispettivament (analiżi MMRM)).
English: Each film-coated tablet contains 5 mg vortioxetine (as hydrobromide).
Maltese: Kull pillola miksija b'rita fiha 5 mg vortioxetine (bħala hydrobromide).
English: Each film-coated tablet contains 10 mg vortioxetine (as hydrobromide).
Maltese: Kull pillola miksija b'rita fiha 10 mg vortioxetine (bħala hydrobromide).
English: The effect in the individual studies was supported by the meta-analysis (MMRM) of the mean change from baseline in MADRS total score at Week 6/8 in the short-term, placebo-controlled studies in adults.
Maltese: L-effett tal-istudji individwali kien sostnut mill-meta-analiżi (MMRM) tal-bidla medja mill-linja bażi fil-punteġġ totali MADRS fil-Ġimgħa 6/8 fl-istudji ta' terminu qasir ikkontrollati mill-plaċebo magħmula fl-adulti.
English: Brintellix 20 mg film-coated tablets EU/1/13/891/027-035
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/891/036 15 ml
English: H. Lundbeck A/S Ottiliavej 9
Maltese: H. Lundbeck A/S Tel: +45
English: If you take medicine to treat depression including Brintellix during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties.
Maltese: Jekk tieħu mediċini biex tikkura d-depressjoni inkluż Brintellix matul l-aħħar 3 xhur tat-tqala tiegħek għandek tkun taf li jistgħu jiġu osservati l-effetti li ġejjin fit-tarbija tat-twelid tiegħek: problemi binnifs, ġilda ta' lewn blu, aċċessjonijiet, bidliet fit-temperatura tal-ġisem, diffikultajiet biex tiekol, rimettar , zokkor baxx fid-demm, muskoli iebsin jew merħija, riflessi esaġerati, rogħda, movimenti mhux volontarji, irritabilità, letarġija, biki l-ħin kollu, ngħas u diffikultajiet fl-irqad.
English: Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment (see section 4.5).
Maltese: Skont ir-rispons tal-pazjent individwali, aġġustament fiddoża jista' jiġi kkunsidrat jekk induttur b'firxa wiesa' taċ-ċitokromju P450 (eż., rifampicin, carbamazepine, phenytoin) jiżdied mal-kura b'vortioxetine (ara sezzjoni 4.2).
English: The pack sizes of 56 x1, 98 x1 and 490 film-coated tablets are presented in unit dose blister.
Maltese: Id-daqsijiet tal-pakkett ta' 56 x 1, 98 x 1 u 490 pillola miksija b'rita huma ppreżentati f'folja b'doża waħda.
English: Patients treated with vortioxetine can abruptly stop taking the medicinal product without the need for a gradual reduction in dose (see section 5.1).
Maltese: Pazjenti kkurati b'vortioxetine jistgħu jwaqqfu t-teħid tal-prodott mediċinali f'daqqa mingħajr ilħtieġa ta' tnaqqis gradwali tad-doża (ara sezzjoni 5.1).
English: - if you are taking other medicines for depression known as non-selective monoamine oxidase inhibitors or selective MAO-A inhibitors.
Maltese: Użu fl-istess ħin ma' inibituri mhux selettivi ta' monoamine oxidase (MAOIs ) jew inibituri selettivi
English: H. Lundbeck AB Tel: +46 40 699 8200
Maltese: Tel: +46 4069 98200
English: EU/1/13/891/040 126 film-coated tablets (9 packs of 14) EU/1/13/891/033 490 film-coated tablets (5 packs of 98x1)
Maltese: EU/1/13/891/034 100 pillola miksijin b'rita EU/1/13/891/035 200 pillola miksijin b'rita
English: In the meta-analysis, the overall mean difference to placebo across the studies was statistically significant: -2.3 points (p = 0.007), -3.6 points (p <0.001), and -4.6 points (p <0.001) for the 5, 10, and 20 mg/day doses, respectively; the 15 mg/day dose did not separate from placebo in the meta-analysis, but the mean difference to placebo was -2.6 points.
Maltese: Fil-meta-analiżi, it-total tal-medja ta' differenza meta mqabbla mal-plaċebo fost il-firxa ta' studji kienet statistikament sinifikanti: -2.3 punti (p = 0.007), -3.6 punti (p <0.
English: Lundbeck España S.A. Tel: +34 93 494 9620
Maltese: Tel: +34 93 494 9620
English: A. LABELLING
Maltese: Syndrome)
English: Package leaflet: Information for the patient Brintellix 20 mg film-coated tablets vortioxetine
Maltese: Informazzjoni għall-pazjent Brintellix 20 mg pilloli miksija b'rita
English: This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Maltese: Din il-mediċina fiha ammonti żgħar ta' ethanol (alkoħol), inqas minn 100 mg f'kull doża.
English: - The review of a signal for anaphylactic reaction reported a total of 40 post-marketing cases, including seven where causality with vortioxetine treatment was considered possible.
Maltese: - Ir-reviżjoni ta' sinjal għal reazzjoni anafilattika, irrappurtat total ta' 40 każ wara t-tqegħid fis-suq, inklużi sebgħa fejn il-kawżalità bi trattament b'vortioxetine kienet ikkunsidrata possibbli.
English: Yellow, almond-shaped 5 x 8.4 mm film-coated tablet (tablet) marked with “TL” on one side and “10” on the other side.
Maltese: Pillola miksija b'rita ta' lewn isfar, forma ta' lewża (5 x 8.4 mm) imnaqqxa b'“TL” fuq naħa waħda u “10” fuq in-naħa l-oħra.
English: EU/1/13/891/038 126 film-coated tablets (9 packs of 14) EU/1/13/891/005 490 film-coated tablets (5 packs of 98x1)
Maltese: EU/1/13/891/013 56 x 1 pilloli miksijin b'rita EU/1/13/891/014 98 x 1 pilloli miksijin b'rita
English: The European Medicines Agency has deferred the obligation to submit the results of studies in major depressive disorder with vortioxetine in children and adolescents aged 7 to 18 years (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'vortioxetine f'disturb depressiv maġġuri fi tfal u adolexxenti b'età minn 7 sa 18-il snin (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Multipack: 490 (5 packs of 98x1) film-coated tablets.
Maltese: Pakkett multiplu: 490 (5 pakketti ta' 98 x 1) pillola miksijin b'rita.
English: 14 film-coated tablets 28 film-coated tablets 98 film-coated tablets 56x1 film-coated tablets 98x1 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Maltese: 14 pillola miksijin b'rita 28 pillola miksijin b'rita 56 x 1 pilloli miksijin b'rita 98 x 1 pilloli miksijin b'rita
English: The efficacy and safety of vortioxetine have been studied in a clinical programme that included more than 6,700 patients, of whom more than 3,700 were treated with vortioxetine in short-term (≤12 weeks) studies of major depressive disorder (MDD).
Maltese: 6,700 pazjent, li minnhom aktar minn 3,700 kienu kkurati b'vortioxetine fi studji fuq żmien qasir (≤ 12-il ġimgħa) ta' disturb depressiv maġġuri (MDD - major depressive disorder).
English: In clinical studies in children and adolescents treated with other antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour, anger) were more frequently observed than in those treated with placebo.
Maltese: Fi studji kliniċi fi tfal u adolexxenti kkurati b'antidepressivi oħra, imġiba relatata ma' suwiċidju (attentat ta' suwiċidju u ħsibijiet ta' suwiċidju) u ostilità (l-iżjed aggressjoni, imġiba konfrontali, rabja)
English: - Based upon the role of serotonin on haemostasis, the mechanism of action of vortioxetine and 63 post-marketing cases retrieved from a signal for haemorrhage with possible causality with vortioxetine, it was considered that haemorrhage should be included as an adverse drug reaction in the product information of vortioxetine.
Maltese: - Ibbażat fuq ir-rwol ta' serotonin fuq l-emostasi, il-mekkaniżmu ta' azzjoni ta' vortioxetine u 63 każ wara t-tqegħid fis-suq miksuba minn sinjal għal emorraġija b'kawżalità possibbli b'vortioxetine, ġie kkunsidrat li l-emorraġija għandha tkun inkluża bħala reazzjoni avversa tal-mediċina fl-informazzjoni tal-prodott ta' vortioxetine.
English: The combination of vortioxetine with a weak reversible and non-selective MAOI, such as the antibiotic linezolid, is contraindicated (see section 4.3).
Maltese: It-teħid flimkien ta' vortioxetine ma' MAOI riversibbli u mhux selettiv dgħajjef bħall-antibijotiku linezolid huwa kontraindikat (ara sezzjoni 4.3).
English: It was to be available as tablets (100 mg and 400 mg).
Maltese: Kellu jiġi f'pilloli (100 u 400 mg).
English: 21 February 2013
Maltese: 21 ta' Frar 2013
English: What is Ruvise?
Maltese: X'inhu Ruvise?
English: Imatinib is a tyrosine-kinase inhibitor.
Maltese: Imatinib hija inibitur tat-tirosin kinażi.
English: Ruvise is a medicine that contains the active substance imatinib.
Maltese: Ruvise hija mediċina li fiha s-sustanza attiva imatinib.
English: Ruvise was expected to be used as an add-on treatment in adults with pulmonary arterial hypertension (PAH, high blood pressure in the arteries of the lungs) to improve exercise capacity (the ability to carry out physical activity).
Maltese: Ruvise kien mistenni jintuża bħala kura supplimentari fl-adulti bi pressjoni arterjali pulmonari għolja (PAH, pressjoni tad-demm għolja fl-arterji tal-pulmun) sabiex itejjeb il-kapaċità tal-eżerċizzju (l-abilità li twettaq attività fiżika).
English: What was Ruvise expected to be used for?
Maltese: Kif kien mistenni jaħdem Ruvise?
English: The applicant presented data from one main study involving 202 patients with PAH.
Maltese: L-applikant ippreżenta dejta minn studju prinċipali wieħed li sar fuq 202 pazjenti bil-PAH.
English: On 17 January 2013 Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ruvise, for the treatment of pulmonary arterial hypertension.
Maltese: Fis-17 ta' Jannar 2013, Novartis Europharm Ltd għarrfet b'mod uffiċjali lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal bidla talawtorizzazzjoni għat-tqegħid fis-suq għal Ruvise, li huwa prodott mediċinali għall-kura ta' pressjoni arterjali pulmonari għolja.
English: Medicines containing imatinib are currently approved in the European Union (EU) for the treatment of different types of cancers.
Maltese: Mediċini li fihom l-imatinib bħalissa huma approvati fl-Unjoni Ewropea (UE) għall-kura ta' tipi differenti ta' kanċers.
English: The Committee also noted the higher unexplained risk of subdural haemorrhage (a type of bleeding in the brain).
Maltese: Il-Kumitat innota wkoll irriskju ogħla u mhux spjegat ta' emorraġija subdurali (tip ta' fsada fil-moħħ).
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated two rounds of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fassal żewġ rawnds ta' mistoqsijiet.
English: In the study, patients were given either imatinib or placebo (a dummy treatment), added to two or more PAH medicines, for 24 weeks.
Maltese: Fl-istudju lpazjenti ngħataw jew l-imatinib jew plaċebo (kura finta), miżjud ma' żewġ mediċini tal-PAH jew aktar tul 24 ġimgħa.
English: In view of the serious side effects observed in some PAH patients, the CHMP considered that more data were needed to identify which patients were at particular risk.
Maltese: Minħabba l-effetti sekondarji serji osservati f'xi pazjenti bil-PAH, is-CHMP qies li kien jenħtieġ aktar dejta biex jiġi identifikat sewwasew liema pazjenti kienu f'riskju partikulari.
English: The Committee was concerned that a beneficial effect of imatinib in PAH had not been sufficiently demonstrated.
Maltese: Il-Kumitat kien imħasseb li l-effett benefiċjali tal-imatinib kontra l-PAH ma ntweriex biżżejjed.
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet il-valutazzjoni tal-applikazzjoni qabel ma ġiet irtirata?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ruvise could not be approved for the treatment of PAH.
Maltese: Abbażi tar-reviżjoni tad-dejta u tat-tweġibiet tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fiżżmien tal-irtirar is-CHMP kellu xi tħassib u kien tal-idea proviżorja li Ruvise ma setax jiġi approvat għall-kura tal-PAH.
English: This means that it blocks some specific enzymes known as tyrosine kinases, which are involved in stimulating cells to divide.
Maltese: Dan ifisser li din timblokka xi enzimi speċifiċi magħrufin bħala tirosin kinażi, li huma involuti fl-istimular tal-qsim taċ-ċelloli.
English: The main measure of effectiveness was the distance that patients could walk during a six-minute walk test.
Maltese: Il-kejl ewlieni tal-effikaċja kienet id-distanza li l-pazjenti setgħu jimxu matul test ta' sitt minuti mixi.
English: Strength
Maltese: Il-pakkett
English: MA (EU) Number Name
Maltese: Numru ta' l-EU
English: Strength Pharmaceutical Form Route of Administration Immediate Packaging
Maltese: Qawwa Għamla farmaċewtika
English: Packaging
Maltese: Isem inventat
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 ta' Marzu 2016 EMA/309645/2016
English: It is only used in combination with rituximab.
Maltese: Jintuża biss f'kombinazzjoni ma' rituximab.
English: • Studies in non-Hodgkin lymphoma included patients with disease characteristics different from those covered by the currently approved indication and investigated a combination of medicines not currently approved.
Maltese: • Studji f'limfoma non-Hodgkin inkludew pazjenti b'karatteristiċi ta' mard differenti minn dawk koperti mill-indikazzjoni approvata attwalment u investigaw kombinazzjoni ta' mediċini mhux approvati attwalment.
English: • a type of non-Hodgkin lymphoma called follicular lymphoma where it is used on its own.
Maltese: • tip ta' limfoma non-Hodgkin imsejħa limfoma follikulari fejn jintuża waħdu.
English: Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called nonHodgkin lymphoma).
Maltese: Attwalment, Zydelig huwa awtorizzat fl-UE biex jikkura żewġ tipi ta' kanċers tad-demm imsejħin lewkimja limfoċitika kronika (CLL-chronic lymphocytic leukaemia) u limfoma follikulari (wieħed minn grupp ta' kanċers li jissejjaħ limfoma non-Hodgkin).
English: The clinical trial in CLL involved patients who had not received previous treatment, some of whom had the 17p deletion or TP53 mutation; however, it also investigated a combination of medicines which is currently not approved.
Maltese: Il-prova klinika f'CLL involviet pazjenti li ma kinux irċevew kura preċedenti, uħud minnhom kellhom tħassir ta' 17p jew mutazzjoni TP53 ; madankollu, investigat ukoll kombinazzjoni ta' mediċini li attwalment mhijiex approvata.
English: There have been reports of serious side effects in clinical studies with the cancer medicine Zydelig.
Maltese: Kien hemm rapporti ta' effetti sekondarji serji fi studji kliniċi bil-mediċina kontra l-kanċer Zydelig.
English: 1 For more information see here.
Maltese: 1 Għal aktar informazzjoni, ara hawn.
English: • Increased rates of serious adverse effects including deaths were seen in 3 clinical trials in the treatment arm evaluating the addition of Zydelig to standard therapy in first-line CLL and relapsed indolent non-Hodgkin lymphoma.
Maltese: • Rati miżjuda ta' effetti avversi serji inkluż imwiet dehru fi 3 provi kliniċi fil-fergħa ta' kura li tevalwa ż-żieda ta' Zydelig ma' terapija standard f'CLL tal-ewwel linja u limfoma non-Hodgkin indolenti rikaduta.
English: Information for patients
Maltese: Zydelig
English: EMA recommends new safety measures for Zydelig
Maltese: L-EMA tirrakkomanda miżuri ta' sigurtà ġodda għal
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended.
Maltese: Monitoraġġ kliniku u tal-laboratorju regolari għal infezzjoni ċitomegalovirus huwa rrakkomandat ukoll.
English: • Further information on Zydelig will be provided as necessary.
Maltese: • Aktar informazzjoni dwar Zydelig tiġi pprovduta jekk ikun hemm bżonn.
English: • If you are taking Zydelig, you will receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia) and be monitored for signs of infections.
Maltese: • Jekk qed tieħu Zydelig, ser tirċievi antibijotiċi biex jimpedixxu tip partikolari ta' infezzjoni talpulmun (Pneumocystis jirovecii pneumonia) u ser tiġi mmonitorjat/a għal sinjali ta' infezzjonijiet.
English: Most deaths related to infections such as Pneumocystis jirovecii pneumonia and cytomegalovirus infections.
Maltese: Ħafna mwiet relatati ma' infezzjonijiet bħal pulmonite Pneumocystis jirovecii u infezzjonijiet b'ċitomegalovirus.
English: • All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and should be monitored for respiratory signs and symptoms.
Maltese: • Il-pazjenti kollha għandhom jirċievu profilassi għal P. jirovecii pneumonia matul kura b'Zydelig u għandhom jiġu mmonitorjati għal sinjali u sintomi respiratorji.
English: These will now be forwarded to the European Commission (EC), which will issue a provisional legally binding decision applicable in all EU Members States.
Maltese: L-istadju finali tal-proċedura ta' rieżami kien l-adozzjoni mill-Kummissjoni Ewropea ta' deċiżjoni legalment vinkolanti applikabbli fl-Istati Membri tal-UE kollha.
English: It should also not be started in previously untreated patients with CLL whose cancer cells have certain genetic mutations (17p deletion or TP53 mutation).
Maltese: Lanqas ma għandu jinbeda f'pazjenti b'CLL mhux ikkurati preċedentament li ċ-ċelloli tal-kanċer tagħhom għandhom ċerti mutazzjonijiet ġenetiċi (tħassir ta' 17p jew mutazzjoni TP53).
English: The PRAC recommends that all patients treated with Zydelig should receive antibiotics to prevent a particular type of lung infection (Pneumocystis jirovecii pneumonia).
Maltese: Il-PRAC irrakkomanda li l-pazjenti kollha kkurati b'Zydelig għandhom jirċievu l-antibijotiċi biex jimpedixxu tip partikolari ta' infezzjoni tal-pulmun (Pneumocystis jirovecii pneumonia).
English: In case the patient has moderate or severe neutropenia treatment with Zydelig may have to be interrupted, in line with the updated summary of product characteristics (SmPC).
Maltese: F'każ li pazjent ikollu newtropenja moderata jew severa, il-kura b'Zydelig tista' tiġi interrotta, b'mod konformi mas-sommarju tal-karatteristiċi tal-prodott (SmPC) aġġornat.
English: • chronic lymphocytic leukaemia in patients who have received previous treatment as well as in previously untreated patients who have certain genetic mutations (17p deletion or TP53 mutation) in their cancer cells.
Maltese: • lewkimja limfoċitika kronika f'pazjenti li rċevew kura preċedenti kif ukoll pazjenti mhux ikkurati preċedentament li għandhom ċerti mutazzjonijiet ġenetiċi (tħassir ta' 17p jew mutazzjoni TP53) fiċ-ċelloli tal-kanċer tagħhom.
English: Once the PRAC review is concluded any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt a final opinion.
Maltese: Ladarba r-rieżami tal-PRAC ikun konkluż, kwalunkwe rakkomandazzjoni ulterjuri ser tintbagħat lillKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli mill-mistoqsijiet dwar mediċini għall-użu mill-bniedem, li jadotta opinjoni finali.
English: • As a precaution and while a thorough review is ongoing, Zydelig should not be started as first-line treatment in patients with CLL who have the 17p deletion or TP53 mutation.
Maltese: • Bħala prekawzjoni u filwaqt li qed isir rieżami bir-reqqa li għaddej il-ħin kollu, Zydelig ma għandux jinbeda bħala kura tal-ewwel linja f'pazjenti b'CLL li għandhom it-tħassir ta' 17p jew mutazzjoni TP53.