FrancophonIA/ELRC3.0 huggingface dataset:
English: Christensen J et al. Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.
Maltese: Prenatal valproate exposure and risk of autism spectrum disorders and childhood autism.
English: Fetal antiepileptic drug exposure: Adaptive and emotional/behavioral functioning at age 6years.
Maltese: Adaptive and emotional/behavioral functioning at age 6years.
English: 5 Cummings C et al. Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine.
Maltese: Neurodevelopment of children exposed in utero to lamotrigine, sodium valproate and carbamazepine.
English: The most common types of malformations include neural tube defects, facial dysmorphism, cleft lip and palate, craniostenosis, cardiac, renal and urogenital defects, limb defects (including bilateral aplasia of the radius), and multiple anomalies involving various body systems.
Maltese: It-tipi l-aktar komuni ta' malformazzjonijiet jinkludu difetti fit-tubu, dismorfiżmu tal-wiċċ, qsim fix-xufftejn u fis-saqaf tal-ħalq, kranjostenożi, difetti kardijaċi, renali u uroġenitali, difetti fid-dirgħajn (inklużi aplasija bilaterali tarradjus), u anomaliji multipli li jinvolvu diversi sistemi tal-ġisem.
English: This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%.
Maltese: Dan huwa riskju akbar ta' malformazzjonijiet maġġuri milli għallpopolazzjoni ġenerali, għal liema r-riskju huwa madwar 2-3%.
English: Data derived from a meta-analysis (including registries and cohort studies) has shown that 10.73% of children of epileptic women exposed to valproate monotherapy during pregnancy suffer from congenital malformations (95% CI: 8.16 -13.29)1.
Maltese: 73% tat-tfal ta' nisa epileptiċi esposti għal monoterapija b'valproate matul it-tqala jsofru minn malformazzjonijiet konġenitali (95% CI: 8.16 -13.29)1.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC for valproate and related substances-containing medicinal products.
Maltese: • Il-Kumitat għall-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal valproate u prodotti mediċinali li fihom sustanzi relatati.
English: 2007 Dec;48(12):2234-40.
Maltese: Epilepsia. 2007 Dec;48(12):2234-40.
English: Lancet Neurol.
Maltese: oħrajn.
English: Current Step 4 version dated July 2000.
Maltese: Verżjoni tal-Pass Attwali 4 datata Lulju 2000.
English: 9 Cohen M.J et al. Fetal Antiepileptic Drug Exposure: Motor, Adaptive and Emotional/Behavioural Functioning at age 3
Maltese: Motor, Adaptive and Emotional/Behavioural Functioning at age 3
English: The CMDh included a clarification about the population affected by the recommendations as these are also applicable to female adolescents (aged between 12 to 16-18 years) according to the ICH E11 age classification of the paediatric population10.
Maltese: Is-CMDh inkluda kjarifika dwar il-popolazzjoni affettwata mir-rakkomandazzjonijiet peress li dawn huma applikabbli wkoll għall-adolexxenti nisa (li għandhom bejn 12 sa 16-18-il sena) skont ilklassifikazzjoni tal-età ICH E11 tal-popolazzjoni pedjatrika10.
English: Limited data suggests that children exposed to valproate in utero may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD)7,8,9.
Maltese: Dejta limitata tissuġġerixxi li t-tfal esposti għal valproate in utero jaf ikollhom aktar probabbiltà li jiżviluppaw sintomi ta' disturb ta' nuqqas ta' attenzjoni/iperattività (ADHD).7,8,9.
English: The PRAC reviewed all available data from pre-clinical studies, pharmacoepidemiological studies, published literature, spontaneous reports as well as the views of the relevant experts (i.e. in neurology, psychiatry, child neuropsychiatry, obstetrics etc.) on the safety and efficacy of valproate and related substances in female children, women of childbearing potential and pregnant women.
Maltese: Il-PRAC irreveda d-dejta kollha disponibbli minn studji ta' qabel l-użu kliniku, studji farmakoepidemjoloġiċi, dokumentazzjoni ppubblikata, rapporti spontanji kif ukoll il-fehmiet tal-esperti rilevanti (jiġifieri fin-newroloġija, il-psikjatrija, in-newropsikjatrija tat-tfal, l-ostetriċja, eċċ.) dwar issigurtà u l-effikaċja ta' valproate u sustanzi relatati fit-tfal bniet, in-nisa li jistgħu joħorġu tqal u n-nisa tqal.
English: Intelligence quotient (IQ) measured in school aged children (age 6) with a history of valproate exposure in utero was on average 7-10 points lower than those children exposed to other antiepileptics.
Maltese: Il-kwozjent ta' intelliġenza (IQ) imkejjel fit-tfal fl-età tal-iskola (ta' 6 snin) bi storja ta' esponiment għal valproate in utero kien bħala medja 7-10 punti aktar baxx minn dak tat-tfal esposti għal antiepilettiċi
English: JAMA.
Maltese: IV.
English: The CMDh, having considered the PRAC recommendation dated 9 October 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, agreed on the variation to the terms of the marketing authorisations of valproate and related substances containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Maltese: Is-CMDh,wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata d-9 ta' Ottubru 2014 skont lArtikolu 107k(1) u (2) tad-Direttiva 2001/83/KE, qabel dwar il-varjazzjoni fit-termini talawtorizzazzjoni għat-tqegħid fis-suq ta' valproate u prodotti mediċinali li fihom sustanzi relatati li għalihom huma stabbiliti s-sezzjonijiet rilevanti tas-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif fl-Anness
English: The CMDh included a clarification on the use of prolonged release formulation to avoid high peak plasma concentrations in the summary of product characteristics.
Maltese: Is-CMDh inkluda kjarifika dwar l-użu ta' formulazzjoni b'rilaxx fit-tul biex jiġu evitati konċentrazzjonijiet fil-plażma għolja fis-sommarju tal-karatteristiċi tal-prodott.
English: The CMDh considered the below PRAC recommendation with regard to valproate and related substances-containing medicinal products:
Maltese: Is-CMDh ikkunsidra r-rakkomandazzjoni tal-PRAC ta' hawn taħt fir-rigward ta' valproate u prodotti mediċinali li fihom sustanzi relatati:
English: Studies in preschool children exposed in utero to valproate show that up to 30-40% experience delays in their early development such as talking and walking later, lower intellectual abilities, poor language skills (speaking and understanding) and memory problems 2,3,4,5.
Maltese: L-istudji fi tfal ta' qabel l-iskola esposti in utero għal valproate juru li sa 30-40% ikollhom dewmien fl-iżvilupp bikri tagħhom bħal li jitkellmu u jimxu tard, abbiltajiet intellettwali aktar baxxi, ħiliet lingwistiċi baxxi (diskors u fehim) u problemi ta' memorja2,3,4,5.
English: The PRAC noted that valproate is considered to be an effective drug in the treatment of epilepsy and of manic episode in bipolar disorder, serious conditions that might be life threatening if not adequately controlled.
Maltese: Il-PRAC innota li valproate huwa kkunsidrat bħala mediċina effikaċi fil-kura ta' epilessija u ta' episodju ta' manija f'disturb bipolari, kundizzjonijiet serji li jistgħu jkunu fatali jekk mhux ikkontrollati adegwatament.
English: Overall summary of the scientific evaluation by PRAC
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika mill-PRAC
English: - Treatment of primary generalised epileptic seizures, secondary generalised epileptic seizures and partial epileptic seizures;
Maltese: − Il-kura ta' aċċessjonijiet epilettiċi ġeneralizzati primarji, aċċessjonijiet epilettiċi ġeneralizzati sekondarji u aċċessjonijiet epilettiċi parzjali;
English: Although the role of confounding factors cannot be excluded, there is evidence in children exposed to valproate that the risk of intellectual impairment may be independent from maternal IQ6.
Maltese: Għalkemm ir-rwol ta' fatturi konfondenti ma jistax jiġi eskluż, hemm evidenza fit-tfal esposti għal valproate li r-riskju ta' indeboliment intellettwali jista' jkun indipendenti mill-IQ tal-omm.6.
English: In view of the risks of valproate use during pregnancy and the available therapeutic alternatives for the treatment of acute migraine attacks, the PRAC concluded that in prophylaxis of migraine attacks valproate should be contraindicated in pregnancy or in women of childbearing potential who are not using effective methods of contraception.
Maltese: Fid-dawl tar-riskji tal-użu ta' valproate waqt it-tqala u l-alternattivi terapewtiċi disponibbli għall-kura ta' attakki ta' emigranja akuti, il-PRAC ikkonkluda li fil-profilassi ta' attakki ta' emigranja, valproate għandu jiġi kontraindikat fit-tqala jew f'nisa li jistgħu joħorġu tqal li mhumiex qegħdin jużaw metodi effikaċi ta' kontraċezzjoni.
English: • The PRAC concluded that valproate and related substances should be contraindicated in prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate.
Maltese: • Il-PRAC ikkonkluda li valproate u sustanzi relatati għandhom jiġu kontraindikati fil-profilassi ta' attakki ta' emigranja fit-tqala u f'nisa li jistgħu joħorġu tqal li mhumiex qegħdin jużaw metodi effikaċi ta' kontraċezzjoni waqt il-kura b'valproate.
English: The PRAC noted that in some Member States valproate is authorised for the prevention of migraine attacks.
Maltese: Il-PRAC innota li f'xi Stati Membri, valproate huwa awtorizzat għall-prevenzjoni ta' attakki ta' emigranja.
English: Core elements of a direct healthcare professional communication (DHPC) were agreed, together with the timelines for its distribution.
Maltese: Sar qbil fuq elementi ewlenin ta' komunikazzjoni professjonali dwar il-kura tas-saħħa diretta, flimkien mal-iskedi ta' żmien għad-distribuzzjoni tagħha.
English: 1 - PRAC recommendation
Maltese: - Rakkomandazzjoni tal-PRAC
English: • The PRAC concluded that valproate and related substances should not be used in female children, women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated in the following indications:
Maltese: • Il-PRAC ikkonkluda li valproate u sustanzi relatati ma għandhomx jintużaw fi tfal bniet, in-nisa li jistgħu joħorġu tqal u n-nisa tqal għall-kura ta' epilessija sakemm kuri alternattivi huma ineffikaċi jew mhux ittollerati fl-indikazzjonijiet li ġejjin:
English: • The PRAC considered that intra-uterine exposure to valproate and related substances is associated with an increased risk of developmental disorders in the offspring.
Maltese: • Il-PRAC ikkunsidra li l-esponiment fl-utru għal valproate u sustanzi relatati huwa assoċjat ma' riskju akbar ta' disturbi fl-iżvilupp fil-wild.
English: The PRAC also confirmed the known risk of congenital anomalies.
Maltese: Il-PRAC ikkonferma wkoll ir-riskju magħruf talanomaliji konġenitali.
English: Therefore, the PRAC concluded that valproate and related substances should not be used in female children, women of childbearing potential and pregnant women for the treatment of epilepsy and manic episode in bipolar disorder unless alternatives treatments are ineffective or not tolerated.
Maltese: Għalhekk, il-PRAC ikkonkluda li valproate u sustanzi relatati ma għandhomx jintużaw fi tfal bniet, in-nisa li jistgħu joħorġu tqal u n-nisa tqal għallkura ta' epilessija u episodju ta' manija f'disturb bipolari sakemm kuri alternattivi ma jkunux effikaċi jew ma jiġux ittollerati.
English: However, the CMDh emphasised that the referral procedure focussed on the risks associated with valproate and related substances in pregnant women and women of childbearing potential; the benefit-risk balance of valproate and related substances was assessed only in this subpopulation, and not in the general patient population for all indications.
Maltese: Madankollu, is-CMDh enfasizza li l-proċedura ta' riferiment iffokat fuq ir-riskji assoċjati ma' valproate u sustanzi relatati fin-nisa tqal u n-nisa li jistgħu joħorġu tqal; il-bilanċ bejn il-benefiċċju u r-riskju ta' valproate u sustanzi relatati ġie vvalutat biss f'din issottopopolazzjoni, u mhux fil-popolazzjoni tal-pazjenti ġenerali għall-indikazzjonijiet kollha.
English: In this respect, the PRAC recommended amendments to the product information, including strengthening of the wording to reflect the current knowledge of risks of developmental disorders and congenital anomalies and communication to healthcare professionals through a direct healthcare professional communication.
Maltese: F'dan ir-rigward, il-PRAC jirrakkomanda emendi fl-informazzjoni dwar il-prodott, inkluż it-tisħiħ talformulazzjoni biex tirrifletti l-għarfien attwali tar-riskji ta' disturbi fl-iżvilupp u anomaliji konġenitali u komunikazzjoni lill-professjonisti fil-kura tas-saħħa permezz ta' Komunikazzjoni Diretta lillProfessjonisti fil-Kura tas-Saħħa.
English: London, 30 March 2010 Doc.
Maltese: Londra, 30 ta' Marzu 2010
English: Ref. EMEA/CHMP/734816/2009 rev. EMEA/H/A-29/1216
Maltese: EMEA/CHMP/734816/2009 rev.
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: L-Artikolu 29 tad-Direttiva 2001/83/KE kif emendata, referenza dwar ir-raġunijiet ta' riskju serju potenzjali għas-saħħa pubblika
English: Questions and answers on the referral for Pantoprazole Bluefish pantoprazole 20 and 40 mg tablets
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Pantoprazole Bluefish pantoprazole 20 u 40 mg pilloli
English: What is Pantoprazole Bluefish?
Maltese: X'inhi Pantoprazole Bluefish?
English: The review was carried out under an ‘Article 29' referral1.
Maltese: Ir-reviżjoni saret skont ir-referenza għall-‘Artikolu 29'1.
English: The active substance in Pantoprazole Bluefish, pantoprazole, is a proton pump inhibitor.
Maltese: Is-sustanza attiva f'Pantoprazole Bluefish, pantoprazole, hija inibitur tal-pompa tal-protoni.
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Austria, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Norway, Poland, Portugal and Spain).
Maltese: Membru' ta' referenza, f'dan il-każ l-Iżvezja) jivvaluta mediċina bil-għan li jagħti awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-‘Istati Membri kkonċernati', f'dan il-każ l-Awstrija, id-Danimarka, il-Ġermanja, il-Finlandja, Franza, l-Ungerija, lIrlanda, l-Italja, l-Olanda, in-Norveġja, il-Polonja, il-Portugall u Spanja).
English: Pantoprozole Bluefish is a generic medicine based on the reference medicine Pantecta.
Maltese: Pantoprozole Bluefish hija mediċina ġenerika bbażata fuq il-mediċina ta' referenza Pantecta.
English: Pantoprazole Bluefish is presented as gastro-resistant tablets.
Maltese: Pantoprazole Bluefish tiġi bħala pilloli gastro-reżistenti.
English: The 20 mg tablets can be used for reflux disease to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth), for the long-term management and prevention of relapse in reflux oesophagitis (inflammation of the gullet, due to acid), for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
Maltese: Il-pilloli ta' 20 mg jistgħu jintużaw għall-mard ta' rifluss biex jikkuraw sintomi bħal ħruq ta' stonku u regurgitazzjoni tal-aċidu (aċidu li jitla' għall-ħalq), għall-ġestjoni fit-tul u l-prevenzjoni ta' rikaduta f'esofaġite ta' rifluss (infjammazzjoni tal-esofagu, minħabba l-aċidu), għall-prevenzjoni tal-ulċeri flistonku li jistgħu jiġu kkawżati minn xi mediċini użati għall-kura ta' uġigħ u infjammazzjonijiet imsejħin mediċini kontra l-infjammazzjoni mhux sterojdali mhux selettivi (NSAIDs), meta l-pazjent ikun jeħtieġ kura kontinwa b'NSAIDs.
English: The 40 mg tablets can be used for more severe acid diseases such as stomach ulcer, duodenal ulcer, Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach) and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcer.
Maltese: Il-pilloli ta' 40 mg jistgħu jintużaw għal mard b'aċidu li jkun aktar sever bħal ulċeri fl-istonku, ulċeri duwodenali, is-sindromu ta' Zollinger-Ellison (kundizzjoni kkawżata minn tnixxija eċċessiva ta' aċidu fl-istonku) u biex l-istonku jkun megħjun jeħles minn batterju msejjaħ Helicobacter pylori, li huwa magħruf li jikkawża ulċera fl-istonku.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Bluefish outweigh its risks, and the marketing authorisation can be granted in Sweden and in the following Member States of the European Union, Austria, Denmark, Germany, Finland, France, Hungary, Ireland, Italy, the Netherlands, Poland, Portugal, Spain as well as in Norway.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) tal-Aġenzija ikkonkluda li l-benefiċċji ta' Pantoprazole Bluefish jisbqu r-riskji tagħha, u l-awtorizzazzjoni għattqegħid fis-suq tista' tingħata fl-Iżvezja u fl-Istati Membri li ġejjin tal-Unjoni Ewropea, l-Awstrija, idDanimarka, il-Ġermanja, il-Finlandja, Franza, l-Ungerija, l-Irlanda, l-Italja, l-Olanda, in-Norveġja, ilPolonja, il-Portugall u Spanja.
English: Bluefish Pharmaceuticals AB submitted Pantoprazole Bluefish to the Swedish medicines regulatory agency for a decentralised procedure.
Maltese: Bluefish Pharmaceuticals AB. issottomettiet Pantoprazole Bluefish lill-aġenzija regolatorja talmediċini Żvediża għal proċedura deċentralizzata.
English: Why was Pantoprazole Bluefish reviewed?
Maltese: Għaliex ġiet riveduta Pantoprazole Bluefish?
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Bluefish.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea dwar l-awtorizzazzjoni għat-tqegħid fis-suq tal-mediċina Pantoprazole Bluefish.
English: The grounds for the referral were concerns expressed by the Dutch, German, Irish and Italian medicines regulatory agencies regarding the bioequivalence study comparing Pantoprazole Bluefish and Pantecta.
Maltese: Ir-raġunijiet għar-riferiment kienu tħassib imfisser mill-aġenziji regolatorji tal-mediċini Olandiżi, Ġermaniżi, Irlandiżi u Taljani dwar l-istudju ta' bijoekwivalenza li jqabbel Pantoprazole Bluefish u Pantecta.
English: However, the member states were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 30 July 2009.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal ftehim u l-aġenzija regolatorja tal-mediċini talIżvezja, irreferiet il-kwistjoni lis-CHMP għal arbitraġġ fit-30 ta' Lulju 2009.
English: By blocking the pumps, pantoprazole reduces acid production.
Maltese: Billi timblokka l-pompi, pantoprazole tnaqqas ilproduzzjoni tal-aċidu.
English: Further information on Bosulif 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: Bosulif is available as tablets (100, 400 and 500 mg).
Maltese: Bosulif jiġi bħala pilloli (100, 400 u 500 mg).
English: This overview was last updated in 04-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'04-2018.
English: Bosulif received a marketing authorisation valid throughout the EU on 27 March 2013.
Maltese: Bosulif irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fis-27 ta' Marzu 2013.
English: The active substance in Bosulif, bosutinib, is a tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Bosulif, bosutinib, hija inibitur tat-tirożina kinażi.
English: Bosulif contains the active substance bosutinib.
Maltese: Bosulif fih is-sustanza attiva bosutinib.
English: Other information about Bosulif
Maltese: Informazzjoni oħra dwar Bosulif
English: Bosulif was investigated in one main study involving 570 patients with Ph+ CML who had previously been treated with at least one tyrosine kinase inhibitor.
Maltese: Bosulif ġie investigat fi studju ewlieni wieħed li fih ħadu sehem 570 pazjent b'Ph+ CML li kienu ngħataw kura preċedenti b'tal-inqas inibitur wieħed tat-tirożina kinażi.
English: The most common side effects with Bosulif (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), thrombocytopenia (low blood platelet counts), abdominal pain (belly ache), vomiting, rash, anaemia (low red blood cell counts), tiredness, fever and increased levels of liver enzymes.
Maltese: L-effetti sekondarji l-aktar komuni b'Bosulif (li jistgħu jaffettwaw aktar minn 1 minn kull 5 persuni) huma dijarea, dardir (nawsja), tromboċitopenja (għadd baxx ta' pjastrini fid-demm), uġigħ addominali (uġigħ fil-żaqq), rimettar, raxx, anemija (għadd baxx ta' ċelluli ħomor tad-demm), għeja, deni u żieda fil-livelli ta' enzimi fil-fwied.
English: What are the risks associated with Bosulif?
Maltese: X'inhuma r-riskji assoċjati ma' Bosulif?
English: What information is still awaited for Bosulif?
Maltese: Liema informazzjoni għadha mistennija għal Bosulif?
English: It blocks the action of enzymes known as Src and Bcr-Abl tyrosine kinases found on leukaemia cells where they are involved in stimulating the cells to divide uncontrollably.
Maltese: Timblokka l-azzjoni ta' enzimi magħrufa bħala tirożina kinażi Src u Bcr-Abl li jinsabu fuq iċ-ċelluli tal-lewkimja fejn huma involuti flistimulazzjoni taċ-ċelloli biex jinqasmu b'mod inkontrollabbli.
English: The most serious side effects (which may affect more than 1 in 20 people) include thrombocytopenia, anaemia, diarrhoea, rash, neutropenia (low levels of neutrophils, a type of white blood cell) and blood tests suggesting damage to the liver and pancreas.
Maltese: L-effetti sekondarji l-aktar serji (li jistgħu jaffettwaw aktar minn 1 minn kull 20 persuna) jinkludu tromboċitopenja, anemija, dijarea, raxx, newtropenja (livelli baxxi ta' newtrofili, tip ta' ċellula bajda tad-demm) u testijiet tad-demm li jissuġġerixxu ħsara fil-fwied u filfrixa.
English: It is used to treat three stages of CML called ‘chronic phase', ‘accelerated phase' and ‘blast phase' in patients who have already been treated with one or more tyrosine kinase inhibitors (medicines for CML which work in a similar way to Bosulif), and when the tyrosine kinase inhibitors called dasatinib, imatinib and nilotinib are not suitable.
Maltese: Jintuża għall-kura ta' tliet stadji ta' CML imsejħa l-”fażi kronika”, il-”fażi aċċellerata” u l-”fażi blast” f'pazjenti li jkunu diġà ngħataw kura b'inibitur wieħed jew aktar tat-tirożina kinażi (mediċini għas-CML li jaħdmu b'mod simili għal Bosulif), u meta l-inibituri tat-tirożina kinażi msejħa dasatinib, imatinib u nilotinib ma jkunux adattati.
English: After one year of treatment, 47% (116 out of 246) of patients treated with Bosulif had a major molecular response, compared with 37% (89 out of 241) of patients treated with imatinib.
Maltese: Il-kejl ewlieni tal-effikaċja kien l-għadd ta' pazjenti li kellhom “rispons molekulari maġġuri” (fejn l-ammont ta' BCR-ABL, il-proteina prodotta mill-kromożoma ta' Philadelphia, fil-mudullun kien naqas ħafna.) Wara sena ta' kura, 47 % (116 minn 246) tal-pazjenti li kienu ngħataw kura b'Bosulif kellhom rispons molekulari maġġuri, meta mqabbel ma' 37% (89 minn 241) tal-pazjenti li kienu ngħataw kura b'imatinib.