FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients who did not adequately respond to 5 mg of the calcium channel blocker amlodipine, the addition of Enviage 150 mg had a blood-pressure-lowering effect similar to that obtained by increasing amlodipine dose to 10 mg, but had a lower incidence of oedema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs. amlodipine 10 mg 11.2%).
Maltese: F'pazjenti li ma kellhomx rispons xieraq għall-5 mg ta' l-imblokkatur tal-kanali tal-calcium amlodipine, iż-żieda ta' Enviage 150 mg kellu effett li jbaxxi l-pressjoni simili għal dak miksub meta d-doża ta' amlodopine tiżdied għal 10 mg iżda kien hemm anqas każijiet ta' edema (aliskiren 150 mg/amlodipine 5 mg 2.1% vs amlodipine 10 mg 11.2%).
English: In clinical studies in hypertensive patients, Enviage had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
Maltese: Fi studji kliniċi f'pazjenti bi pressjoni għolja, Enviage ma kellux effetti klinikament importanti fuq il-kolesterol totali, lipoproteina tal-kolesterol ta' densità għolja (HDL-C), trigliċeridi ta' waqt is-sawm, glucose ta' waqt is-sawm jew uric acid.
English: In clinical studies Enviage has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated glomerular filtration rate (GFR) < 30 ml/min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Maltese: Fil-provi kliniċi, Enviage ma ġiex investigat f'pazjenti li għandhom il-pressjoni għolja u li jbatu minn indeboliment renali sever (krejatinina fis-serum ≥ 150 μmol/l jew 1.70 mg/dl fin-nisa u ≥ 177 μmol/l jew 2.00 mg/dl fl-irġiel u/jew rata ta' filtrazzjoni fil-glomeruli (GFR) stmata < 30 ml/min), li kellhom dijalisi fil-passat, sindrome nefrotika jew pressjoni għolja renovaskulari.
English: You should not take Enviage together with grapefruit juice.
Maltese: M'ghandekx tieħu Enviage mal-meraq tal-grejpfrut.
English: Warfarin The effects of Enviage on warfarin pharmacokinetics have not been evaluated.
Maltese: Warfarin L-effetti ta' Enviage fuq il-farmakokinetika ta' warfarin ma kienux evalwati.
English: In diabetic hypertensive patients, Enviage provided additive blood pressure reductions when added to ramipril, while the combination of Enviage and ramipril had a lower incidence of cough (1.8%) than ramipril (4.7%).
Maltese: F'pazjenti dijabetiċi li għandhom il-pressjoni għolja, Enviage ipprovda tnaqqis addittiv tal-pressjoni tad-demm meta ngħata ma' ramipril, filwaqt li l-kombinazzjoni ta' Enviage u ramipril kellha anqas każijiet ta' sogħla (1.8%) minn ramipril (4.7%).
English: Combination therapy studies are available for Enviage added to the diuretic hydrochlorothiazide, the ACEI ramipril, the calcium channel blocker amlodipine, the angiotensin receptor antagonist valsartan, and the beta blocker atenolol.
Maltese: Hemm studji b'terapija ta' kombinazzjoni għal Enviage miżjud mad-dijuretiku hydrochlorthiazide, lACEI ramipril, l-imblukkatur tal-kanali tal-calcium amlodipine, l-antagonist tar-riċettur ta' langiotensin valsartan, u l-imblukkatur beta atenolol.
English: Treatment with Enviage resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Maltese: Kura b'Enviage wasslet għal inċidenza globali ta' reazzjonijiet avversi simili għal plaċebo sa' 300 mg.
English: Enviage did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs. 1.9% for placebo) of serum potassium concentration ≥6.0 mmol/l, although this was not statistically significant.
Maltese: Enviage ma effettwax ilkonċentrazzjoni fis-serum tal-krejatinina iżda kien assoċjat ma' żieda fil-frekwenza (4.2% vs 1.9% għal plaċebo) tal-konċentrazzjoni tal-potassium fis-serum ≥ 6.0 mmol/l, għalkemm dan ma kienx statistikament sinifikanti.
English: Coadministration of Enviage had no significant impact on atorvastatin, valsartan, metformin or amlodipine pharmacokinetics.
Maltese: Meta Enviage ingħata ma' atorvastatin, valsartan, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il-farmakokinetika tagħhom.
English: Serum potassium: Increases in serum potassium were minor and infrequent in patients with essential hypertension treated with Enviage alone (0.9% compared to 0.6% with placebo).
Maltese: Żiediet tal-potassium fis-serum kienu minuri u mhux frekwenti f'pazjenti bilpressjoni għolja naturali kkurata b'Enviage waħdu (0.9% imqabbla ma' 0.6% bil-plaċebo).
English: EU/1/07/406/011 EU/1/07/406/012 EU/1/07/406/013 EU/1/07/406/014 EU/1/07/406/015 EU/1/07/406/016
Maltese: EU/1/07/406/011 EU/1/07/406/012 EU/1/07/406/013 EU/1/07/406/014
English: In diabetic hypertensive patients, Enviage monotherapy was safe and effective.
Maltese: F'pazjenti dijabetiċi bil-pressjoni għolja, monoterapija ta' Enviage kienet sigura u effettiva.
English: However, in one study where Enviage was used in combination with an ACEI in a diabetic population, increases in serum potassium were more frequent (5.5%).
Maltese: Madankollu, fi studju wieħed fejn Enviage intuża ma' ACEI f'popolazzjoni ta' pazjenti dijabetiċi iżżiediet tal-potassium fis-serum kienu aktar frekwenti (5.5%).
English: EU/1/07/406/001 EU/1/07/406/002 EU/1/07/406/003 EU/1/07/406/004 EU/1/07/406/005 EU/1/07/406/006 EU/1/07/406/008
Maltese: EU/1/07/406/001 EU/1/07/406/002 EU/1/07/406/003 EU/1/07/406/004
English: In experimental animals, it has been shown that P-gp is a major determinant of Enviage bioavailability.
Maltese: F'annimali esperimentali, intwera li P-gp jiddetermina bil-kbir il-biodisponibilità ta' Enviage.
English: Enviage 150 mg film-coated tablets Aliskiren
Maltese: Enviage 150 mg pilloli miksijin b'rita Aliskiren
English: What Enviage contains - The active substance is aliskiren (as hemifumarate) 300 mg. - The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,
Maltese: - Is-sustanzi l-oħra huma crospovidone, hypromellose, magnesium stearate, macrogol,
English: This condition should be corrected prior to administration of Enviage, or the treatment should start under close medical supervision.
Maltese: Din ilkundizzjoni għandha tiġi korretta qabel ma jingħata Enviage, jew il-kura għandha tinbeda taħt superviżjoni medika stretta.
English: Enviage 300 mg film-coated tablets Aliskiren
Maltese: Enviage 300 mg pilloli miksijin b'rita Aliskiren
English: When administered with atorvastatin, steady-state Enviage AUC and Cmax increased by 50%.
Maltese: Meta ngħata ma' atorvastatin, l-AUC u Cmax fi stat fiss ta' Enviage żdiedu b'50%.
English: In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Enviage 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
Maltese: F'pazjenti obeżi li għandhom il-pressjoni għolja li ma wrewx rispons xieraq għal HCTZ 25 mg, kura bl-inklużjoni ta' Enviage 300 mg ipprovdiet tnaqqis addizzjonali fil-pressjoni tad-demm li seta' jitqabbel ma' kura bl-inklużjoni ta' irbesartan 300 mg jew amlodipine 10 mg.
English: In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Enviage 150 mg was well tolerated.
Maltese: Fi studju ta' 3 xhur fuq 302 pazjenti b'insuffiċjenza tal-qalb stabbli u mhux severa (Klassi funzjonali NYHA II u III), li kollha kemm huma kienu qed jirċievu terapija standard għall-insuffiċjenza tal-qalb iż-żieda ta' Rasliez 150 mg kienet tollerata sew.
English: NAME OF THE MEDICINAL PRODUCT Enviage 150 mg film-coated tablets Aliskiren
Maltese: TAL-PRODOTT MEDIĊINALI Enviage 150 mg pilloli miksijin b'rita Aliskiren
English: NAME OF THE MEDICINAL PRODUCT Enviage 150 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI Enviage 150 mg pilloli miksijin b'rita
English: B-type natriuretic peptide (BNP) levels were reduced by 25% in the Enviage arm compared to placebo.
Maltese: Il-livelli ta' peptajd natrijuretiku tat-tip-B (BNP) kienu mnaqqsa b'25% fil-fergħa ta' Enviage meta mqabbla mal-plaċebo għalkemm is-sinifikat kliniku għadu mhux magħruf.
English: NAME OF THE MEDICINAL PRODUCT Enviage 300 mg film-coated tablets Aliskiren
Maltese: TAL-PRODOTT MEDIĊINALI Enviage 300 mg pilloli miksijin b'rita Aliskiren
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/406/007
Maltese: FIS-SUQ EU/1/07/406/007
English: In hypertensive patients, once-daily administration of Enviage at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Maltese: F'pazjenti bil-pressjoni għolja, l-għotja darba kuljum ta' Enviage b'dożi ta' 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid-doża fil-pressjoni tad-demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta' 24 siegħa ta' l-intervall bejn id-dożi (b'hekk żammew il-benefiċċju ta' kmieni filgħodu) b'medja fil-proporzjon bejn l-ogħla u l-anqas għar-rispons dijastoliku sa' 98% għad-doża ta' 300 mg. 85 sa 90% ta' l-effett massimu li jbaxxi l-pressjoni deher wara ġimgħatejn.
English: What Enviage looks like and contents of the pack Enviage 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Maltese: Enviage 150 mg pilloli miksijin b'rita huma pilloli roża ċar, konvessi miż-żewġ naħat, tondi, ittimbrati ‘IL' fuq naħa u ‘NVR' fuq in-naħa l-oħra.
English: Compared to a diuretic (hydrochlorothiazideHCTZ), Enviage 300 mg lowered systolic/diastolic blood pressure by 17.0/12.3 mmHg, compared to 14.4/10.5 mmHg for HCTZ 25 mg after 12 weeks of treatment.
Maltese: Studji b'monoterapija b'Enviage urew li l-effetti li jbaxxi l-pressjoni kienu jitqabblu ma' klassijiet oħra ta' aġenti li jbaxxu l-pressjoni inklużi ACEI u ARB. Meta mqabbel ma' dijuretiku (hydrochlorothiazide - HCTZ), Enviage 300 mg naqqas il-pressjoni sistolika/dijastolika tad-demm b'17.0/12.3 mmHg, imqabbel ma' 14.
English: NAME OF THE MEDICINAL PRODUCT Enviage 300 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI Enviage 300 mg pilloli miksijin b'rita
English: The clinical relevance of a reduction in UACR is not established in the absence of an effect on blood pressure.
Maltese: Ir-rilevanza klinika tat-tnaqqis fl-UACR mhux stabbilit fl-assenza ta' effett fuq il-pressjoni tad-demm.
English: What Enviage looks like and contents of the pack Enviage 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Maltese: Id-Dehra ta' Enviage u l-kontenuti tal-pakkett Enviage 300 mg pilloli miksijin b'rita huma pilloli aħmar ċar, konvessi miż-żewġ naħat, f'għamla ovali, ittimbrati ‘IU' fuq naħa u ‘NVR' fuq in-naħa l-oħra.
English: Preliminary data suggest that irbesartan may decrease Enviage AUC and Cmax.
Maltese: Tagħrif preliminari jindika li irbesartan jista' jnaqqas xi ftit l-AUC u s-Cmax ta' Enviage.
English: Enviage induced an additive blood-pressure-lowering effect when added to hydrochlorothiazide and to ramipril.
Maltese: Enviage ikkawża tnaqqis fil-pressjoni tad-demm akbar meta żdied ma' hydrochlorthiazide u ma' ramipril.
English: The MAH must ensure that the system of pharmacovigilance, as described in version 8.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jiżgura li s-sistema ta' farmakoviġilanza, kif deskritta fil-verżjoni 8.0 inkluża f'Modulu 1.8.1 tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott ikun fis-suq.
English: 14 film-coated tablets
Maltese: 14 pillola miksija b'rita
English: Enviage belongs to a new class of medicines called renin inhibitors.
Maltese: Rasliez jagħmel parti minn klassi ġdida ta' mediċini li jissejjħu inibituri ta' renin.
English: --1 Inactivated Coxiella burnetii, strain Nine Mile: ≥72 QF Units*/ml.
Maltese: --1 Coxiella burnetii inattivat, razza Nine Mile: > 72 Unità QF*/ml *Unità QF (tad-deni Q): qawwa relattiva għall-antiġen ta' fażi I imkejjel b'ELISA meta mqabbel ma' oġġett ta' riferiment.
English: * QF (Q fever) Unit: relative potency of phase I antigen measured by ELISA in comparison with a reference item.
Maltese: Speċi li fuqhom għandu jintuża l-prodott
English: Imbruvica is available as capsules (140 mg) and tablets (140, 280, 420 and 560 mg).
Maltese: Imbruvica jiġi bħala kapsuli (140 mg) u pilloli (140, 280, 420 u 560 mg).
English: Further information on Imbruvica can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/imbruvica .
Maltese: Aktar informazzjoni dwar Imbruvica tinstab fis-sit web tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/imbruvica.
English: These diseases are rare, and Imbruvica was designated an ‘orphan medicine' (a medicine used in rare diseases) for chronic lymphocytic leukaemia on 26 April 2012, mantle cell lymphoma on 12 March 2013 and Waldenström's macroglobulinaemia on 29 April 2014.
Maltese: Dan il-mard huwa rari, u Imbruvica ġie denominat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) għal lewkimja limfoċitika kronika fis-26 ta' April 2012, linfoma taċ-ċellola mantellari fit12 ta' Marzu 2013 u makroglobulinemija ta' Waldenström fid-29 ta' April 2014.
English: Imbruvica contains the active substance ibrutinib.
Maltese: Imbruvica fih is-sustanza attiva l-ibrutinib.
English: Waldenström's macroglobulinaemia
Maltese: Makroglobulinemija ta' Waldenström
English: Other information about Imbruvica
Maltese: Informazzjoni oħra dwar Imbruvica
English: The average duration of response to treatment was 17.5 months.
Maltese: Id-durata medja tar-rispons għall-kura kienet 17.5 xhur.
English: The most serious side effects are neutropenia, pneumonia (lung infection) and thrombocytopenia.
Maltese: L-effetti sekondarji l-aktar serji huma newtropenja, pulmonite (infezzjoni filpulmun) u tromboċitopenja.
English: What are the risks associated with Imbruvica?
Maltese: X'inhuma r-riskji assoċjati ma' Imbruvica?
English: The active substance in Imbruvica, ibrutinib, works against cancerous B lymphocytes, a type of white blood cells.
Maltese: Is-sustanza attiva f'Imbruvica, l-ibrutinib, taħdem kontra limfoċiti B kanċerużi, tip ta' ċelloli bojod taddemm.
English: Chronic lymphocytic leukaemia
Maltese: Lewkimja limfoċitika kronika
English: • Waldenström's macroglobulinaemia (also known as lymphoplasmacytic lymphoma) Imbruvica can be taken alone but can also be taken with bendamustine and rituximab or with obinutuzumab in certain patients with CLL and with rituximab in patients with Waldenström's macroglobulinaemia.
Maltese: • makroglobulinemija ta' Waldenström (magħrufa wkoll bħala linfoma linfoplasmaċitika) Imbruvica jista' jittieħed waħdu iżda jista' jittieħed wkoll ma' bendamustine u rituximab jew ma' obinutuzumab f'ċerti pazjenti b'CLL u ma' rituximab f'pazjenti bil-makroglobulinemija ta' Waldenström.
English: For patients with mantle cell lymphoma the dose is 560 mg once a day, for patients with chronic lymphocytic leukaemia or Waldenström's macroglobulinaemia the usual dose of Imbruvica is 420 mg once a day.
Maltese: Għall-pazjenti bil-linfoma taċċellola mantellari d-doża hija 560 mg darba kuljum, għall-pazjenti bil-lewkimja limfoċitika kronika jew bil-makroglobulinemija ta' Waldenström id-doża normalment tkun 420 mg darba kuljum.
English: The most common side effects with Imbruvica (which may affect more than 1 in 5 people) are diarrhoea, neutropenia (low levels of neutrophils, a type of white blood cell), pain in muscles and bones, haemorrhage (bleeding), bruising, rash, feeling sick and thrombocytopenia (low blood platelet counts).
Maltese: L-effetti sekondarji l-aktar komuni b'Imbruvica (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma dijarea, newtropenja (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), uġigħ fil-muskoli u fl-għadam, emorraġija (fsada), tbenġil, raxx, tħossok ma tiflaħx u tromboċitopenja (għadd baxx ta' pjastrini tad-demm).
English: In a study in 229 previously untreated patients, after 31 months, 79% of patients treated with Imbruvica and obinutuzumab were alive with their disease not having progressed compared with 36% of patients who took chlorambucil and obinutuzumab.
Maltese: Fi studju fuq 229 pazjent li ma kinux ikkurati preċedentement, wara 31 xahar, 79 % tal-pazjenti kkurati b'Imbruvica u b'obinutuzumab kienu ħajjin u l-marda tagħhom ma kinitx ipprogressat meta mqabbla ma' 36 % tal-pazjenti li ħadu chlorambucil u obinutuzumab.
English: Imbruvica received a marketing authorisation valid throughout the EU on 21 October 2014.
Maltese: Imbruvica ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-21 ta' Ottubru 2014.
English: In a study involving 150 patients with Waldenström's macroglobulinaemia, after 26 months, death or signs that the cancer was progressing occurred in 19% of patients who took Imbruvica together with rituximab compared with 56% of patients who took only rituximab.
Maltese: Fi studju li fih ħadu sehem 150 pazjent bil-makroglobulinemija ta' Waldenström, wara 26 xhar, mewt jew sinjali li l-kanċer kien qiegħed jipprogressa seħħew fi 19 % tal-pazjenti i ħadu Imbruvica flimkien ma' rituximab meta mqabbla ma' 56 % tal-pazjenti li ħadu biss rituximab.
English: In a study in 578 patients whose disease had not responded to or had come back after previous treatment, death or signs that the cancer was progressing occurred in 19% of patients (56 of 289) who took Imbruvica together with the cancer medicines bendamustine and rituximab compared with 63% (183 of 289) in those who took bendamustine and rituximab without Imbruvica.
Maltese: Fi studju fuq 578 pazjent li l-marda tagħhom ma kinitx irrispondiet għall-kura jew li reġgħet feġġet wara kura preċedenti, mewt jew sinjali li l-kanċer kien qiegħed jipprogressa seħħew fi 19 % talpazjenti (56 minn 289) li ħadu Imbruvica flimkien mal-mediċini kontra l-kanċer bendamustine u rituximab meta mqabbla ma' 63 % (183 minn 289) f'dawk li ħadu bendamustine u rituximab mingħajr Imbruvica.
English: In a study involving 269 patients who had not been treated before, around 90% of patients receiving Imbruvica were still alive with their disease not having progressed after 1.5 years of treatment compared with around 52% of patients receiving a cancer medicine called chlorambucil.
Maltese: Fi studju li fih ħadu sehem 269 pazjent li ma kinux ġew ikkurati qabel, madwar 90 % tal-pazjenti li rċevew Imbruvica kienu għadhom ħajjin u l-marda tagħhom ma kinitx ipprogressat wara sena u nofs ta' kura meta mqabbla ma' madwar 52 % tal-pazjenti li rċevew mediċina kontra l-kanċer imsejħa chlorambucil.
English: A second study in 280 such patients compared Imbruvica with another cancer medicine, temsirolimus.
Maltese: It-tieni studju fuq 280 pazjent bħal dawn qabbel Imbruvica ma' mediċina oħra kontra l-kanċer, temsirolimus.
English: In addition Imbruvica was shown to be effective in patients with Waldenström's macroglobulinaemia..
Maltese: Barra minn hekk Imbruvica ntwera li kien effettiv fuq pazjenti bil-makroglobulinemija ta' Waldenström.
English: In one study in 391 patients whose disease did not respond to or had come back after previous treatment, 66% of patients receiving Imbruvica were still alive after one year with their disease not having progressed compared with around 6% of patients receiving another cancer medicine, ofatumumab.
Maltese: Fi studju wieħed fuq 391 pazjent li l-marda tagħhom ma rrispondietx għall-kura jew li reġgħet feġġet wara kura preċedenti, 66 % tal-pazjenti li rċevew Imbruvica kienu għadhom ħajjin wara sena u lmarda tagħhom ma kinitx ipprogressat meta mqabbla ma' madwar 6 % tal-pazjenti li rċevew mediċina oħra kontra l-kanċer, ofatumumab.
English: By blocking Btk, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.
Maltese: Billi timblokka l-Btk, l-ibrutinib tnaqqas is-sopravivenza u l-migrazzjoni tal-limfoċiti B, u b'hekk iddewwem il-progressjoni tal-kanċer.
English: The side effects of the medicine were considered acceptable.
Maltese: L-effetti sekondarji tal-mediċina kienu kkunsidrati aċċettabbli.
English: As for all medicines, data on the use of Imbruvica are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Imbruvica hija ssorveljata kontinwament.
English: Imbruvica is a medicine for treating adult patients with the following blood cancers:
Maltese: Imbruvica huwa mediċina għall-kura ta' pazjenti adulti bil-kanċers tad-demm li ġejjin:
English: Response to treatment was measured as a reduction in the blood levels of the protein IgM, which is present in high levels in patients with Waldenström's disease.
Maltese: Ir-rispons għall-kura tkejjel bħala tnaqqis fil-livelli fid-demm tal-proteina IgM, li tinsab f'livelli għoljin f'pazjenti bil-marda ta' Waldenström.
English: It does this by blocking an enzyme called Bruton's tyrosine kinase (Btk), which promotes survival of B lymphocytes and their migration to the organs where these cells normally divide.
Maltese: Dan isir billi timblokka enzima li tissejjaħ tirożina kinażi ta' Bruton (Btk), li tippromwovi ssopravivenza ta' limfoċiti B u l-migrazzjoni tagħhom lejn l-organi fejn normalment jinqasmu dawn iċċelloli.
English: In a study in 111 patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, 21% of patients taking Imbruvica had complete response (i.e. disappearance of all signs of cancer) and 47% had partial response (i.e. the patient improved but some signs of the disease remained).
Maltese: Fi studju fuq 111-il pazjent bil-linfoma taċ-ċellola mantellari li ma rrispondietx għall-kura jew reġgħet feġġet wara kura preċedenti, 21 % tal-pazjenti li ħadu Imbruvica kellhom rispons sħiħ (jiġifieri lgħajbien tas-sinjali kollha tal-kanċer) u 47 % kellhom rispons parzjali (jiġifieri l-pazjent mar għallaħjar iżda ċertu sinjali tal-marda baqgħu).
English: In one main study involving 63 patients who had previously received another treatment for Waldenström's macroglobulinaemia, the disease responded to treatment with Imbruvica in 87% of patients.
Maltese: Fi studju ewlieni wieħed li fih ħadu sehem 63 pazjent li preċedentement kienu rċevew kura oħra għallmakroglobulinemija ta' Waldenström, il-marda rrispondiet għall-kura b'Imbruvica f'87 % tal-pazjenti.
English: How is Imbruvica used?
Maltese: Kif jintuża Imbruvica?
English: The company that markets Imbruvica needs to provide further data on the benefits of Imbruvica in the treatment of chronic lymphocytic leukaemia from follow-up of previously treated patients.
Maltese: Il-kumpanija li tqiegħed Imbruvica fis-suq jeħtieġ li tipprovdi aktar data dwar il-benefiċċji ta' Imbruvica fil-kura tal-lewkimja limfoċitika kronika minn segwitu ta' pazjenti li ġew ikkurati preċedentement.
English: • chronic lymphocytic leukaemia (CLL) in both previously treated and untreated patients;
Maltese: • lewkimja limfoċitika kronika (CLL) f'kemm pazjenti kkurati preċedentement kif ukoll f'dawk li ma kinux;
English: St. John's wort (a herbal remedy used for depression and anxiety) must not be used in patients treated with Imbruvica.
Maltese: John's wort (rimedju erbali li jintuża għad-dipressjoni u għall-ansjetà) m'għandux jintuża f'pazjenti kkurati b'Imbruvica.
English: Side effects reported with Imbruvica are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati b'Imbruvica huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: What measures are being taken to ensure the safe and effective use of Imbruvica?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Imbruvica?
English: 1 Procedure numbers: EMEA/H/A-107/1287; EMEA/H/000607/A-20/0021; EMEA/H/C/000315/A-20/0040; and EMEA/H/C/000602/A-20/0008.
Maltese: 1 Numru tal-proċedura EMEA/H/A-107/1287; EMEA/H/000607/A-20/0021; EMEA/H/C/000315/A-20/0040;