FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Naglazyme.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Naglazyme.
English: It should be given where resuscitation equipment is available in case of a medical emergency.
Maltese: Għandu jingħata fejn ikun hemm tagħmir ta' risuxxitazzjoni disponibbli f'każ ta' emerġenza medika.
English: Because the number of patients with MPS VI is low, the disease is considered ‘rare', and Naglazyme was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 February 2001.
Maltese: Peress li n-numru ta' pazjenti li jbatu mill-MPS VI huwa wieħed baxx, il-marda hi kkunsidrata bħala ‘rari', u fl-14 ta'Frar 2001, Naglazyme ġie kklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari).
English: Why has Naglazyme been approved?
Maltese: Għaliex ġie approvat Naglazyme?
English: What is the risk associated with Naglazyme?
Maltese: X'inhu r-riskju assoċjat ma' Naglazyme?
English: In studies, the most common side effects with Naglazyme (seen in more than 1 patient in 10) were ear pain, dyspnoea (difficulty breathing), abdominal pain and general pain.
Maltese: Fl-istudji, l-iktar effetti sekondarji komuni b'Naglazyme (li dehru f'iktar minn pazjent 1 minn kull 10) kienu wġigħ fil-widnejn, dispnea (diffikultà fin-nifs), uġigħ addominali u wġigħ ġenerali.
English: The Committee noted that, although patients under five years of age were not included in the main study of Naglazyme, it is important that they are treated if they have a severe form of MPS VI. Naglazyme has been authorised under ‘exceptional circumstances'.
Maltese: Il-Kumitat innota li, minkejja li pazjenti taħt il-ħames snin ma kinux inklużi fl-istudju ewlieni ta' Naglazyme, huwa importanti li jiġu ttrattati jekk ikollhom forma gravi ta' MPS VI. Naglazyme ġie awtorizzat taħt ‘ċirkostanzi eċċezzjonali'.
English: Naglazyme has been compared with placebo (a dummy treatment) in one main study involving 39 patients with MPS VI aged between five and 29 years.
Maltese: Naglazyme tqabbel ma' plaċebo (trattament finta) fi studju ewlieni li kien jinvolvi 39 pazjent b'MPS VI ta' bejn ħames snin u 29 sena.
English: The company that makes Naglazyme is carrying out studies looking at the long-term safety and effectiveness of Naglazyme in pregnant and breast-feeding women and in children under the age of five years, to see if they develop antibodies (proteins that are produced in the body in response to Naglazyme that could affect the response to treatment) and to look at the medicine's side effects.
Maltese: Il-kumpanija li tipproduċi Naglazyme qiegħda twettaq studji biex teżamina s-sigurtà u l-effikaċja ta' Naglazyme fuq tul ta' żmien twil f'nisa tqal u li qegħdin ireddgħu u fi tfal taħt il-ħames snin, sabiex tara jekk dawn jiżviluppawx antikorpi (proteini prodotti fil-ġisem bħala rispons għal Naglazyme li jistgħu jaffettwaw ir-rispons għat-trattament) u sabiex jiġu osservati l-effetti sekondarji tal-mediċina.
English: What is Naglazyme?
Maltese: Kif jintuża Naglazyme?
English: The CHMP decided that Naglazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Naglazyme huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: This disease is caused by the lack of an enzyme called N-acetylgalactosamine 4-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
Maltese: Jekk l-enzima ma tkunx preżenti, il-GAGs ma jkunux jistgħu jitkissru u jkomplu jakkumulaw fiċ-ċelloli.
English: How has Naglazyme been studied?
Maltese: Kif jaħdem Naglazyme?
English: It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg and 10/320/25 mg.
Maltese: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg u 10/320/25 mg.
English: The full EPAR for Dafiro HCT can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Dafiro HCT jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Dafiro HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Maltese: It-tnaqqis medju fil-pressjoni taddemm kien madwar 39.7/24.7 mmHg f'pazjenti li kienu fuq Dafiro HCT meta mqabbel ma' 32/19.7 mmHg, 33.5/21.5 mmHg u 31.5/19.5 mmHg f'pazjenti li kienu qegħdin jieħdu valsartan/idroklorotijażide, valsartan/amlodipina u idroklorotijażide/amlodipina rispettivament.
English: The daily dose of Dafiro HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Maltese: Id-doża ta' kuljum ta' Dafiro HCT ma għandhiex taqbeż l-10 mg amlodipina, 320 mg valsartan u 25 mg idroklorotijażide.
English: The most common side effects with Dafiro HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Maltese: L-effetti sekondarji l-aktar komuni b'Dafiro HCT (li dehru f'madwar pazjent 1 u 10 pazjenti f'100) huma ipokaljemija (livelli baxxi ta' potassju fid-demm), sturdament, uġigħ ta' ras, ipotensjoni (pressjoni taddemm baxxa), dispepsija (qrusa tal-istonku), pollakjurija (frekwenza anormali tal-awrina), għejja u edema (żamma tal-fluwidi).
English: Dafiro HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Maltese: Dafiro HCT huwa mediċina li fiha tliet sustanzi attivi, l-amlodipina, il-valsartan u l-idroklorotijażide.
English: This is a summary of the European public assessment report (EPAR) for Dafiro HCT.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Dafiro HCT.
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Dafiro HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Maltese: Barra minn hekk, sar studju ewlieni f'2,271 pazjent b'ipertensjoni minn moderata għal gravi bl-ogħla konċentrazzjoni ta' Dafiro HCT (320 mg valsartan, 10 mg amlodipina u 25 mg idroklorotijażide).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dafiro HCT on 4 November 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Dafiro HCT valida fl-Unjoni Ewropea kollha fl-4 ta' Novembru 2009.
English: The three active substances in Dafiro HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Maltese: It-tliet sustanzi attivi f'Dafiro HCT huma mediċini antiipertensivi li diġà qegħdin jintużaw fl-Unjoni Ewropea (UE).
English: Dafiro HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Dafiro HCT.
Maltese: Dafiro HCT ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanzi attivi, għal sulfonamidi oħra, għal derivattivi diidropiridiniċi jew għal kwalunkwe ingredjent ieħor f'Dafiro HCT.
English: Finally, Dafiro HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Maltese: Fl-aħħar nett, Dafiro HCT ma jistax jintuża f'pazjenti b'ipokalemija (livelli baxxi ta' potassju fid-demm), iponatremija (livelli baxxi ta' sodju fid-demm) u iperkalċemija (livelli għoljin tal-kalċju fid-demm) li ma jirrispondux għall-kura u f'pazjenti b'iperuriċemija (livelli għoljin ta' aċtu uriku fid-demm) li tikkawża s-sintomi.
English: For the full list of all side effects reported with Dafiro HCT, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Dafiro HCT, ara l-fuljett ta' tagħrif.
English: What is the risk associated with Dafiro HCT?
Maltese: X'inhu r-riskju assoċjat ma' Dafiro HCT?
English: What is Dafiro HCT?
Maltese: X'inhu Dafiro HCT?
English: Dafiro HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Maltese: Dafiro HCT jittieħed oralment bħala pillola waħda darba kuljum, fl-istess ħin tal-jum u preferibbilment filgħodu.
English: Why has Dafiro HCT been approved?
Maltese: Għaliex ġie approvat Dafiro HCT?
English: For all doses, Dafiro HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Maltese: Għad-dożi kollha, Dafiro HCT issodisfa wkoll ir-rekwiżiti sabiex juri li kien komparabbli malkombinazzjonijiet tas-sustanzi attivi individwali meħuda separatament.
English: How has Dafiro HCT been studied?
Maltese: Kif ġie studjat Dafiro HCT?
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Maltese: Bit-tnaqqis tal-pressjoni tad-demm, jitnaqqsu rriskji assoċjati ma' pressjoni għolja tad-demm, bħall-puplesija.
English: • PRES should be considered in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function.
Maltese: • PRES għandu jitqies fi kwalunkwe pazjent b'aċċessjonijiet, uġigħ ta' ras, disturbi talvista, konfużjoni jew funzjoni mentali alterata.
English: • Whose ECG QTc interval is greater than 480 msec
Maltese: • li għandhom QTc tal-ECG itwal minn 480 msec
English: • That vandetanib may cause Posterior reversible encephalopathy syndrome (PRES) also known as Reversible posterior leukoencephalopathy syndrome (RPLS)
Maltese: • Vandetanib jista' jikkawża sindrome enċefalopatika posterjuri riversibbli (PRES) magħrufa wkoll bħala sindrome lewko-enċefalopatika posterjuri riversibbli (RPLS)
English: • The need for an ECG, and serum levels of potassium, calcium and magnesium and thyroid stimulating hormone (TSH) and the times and situations when it should be performed
Maltese: • Il-bżonn ta' ECG, u livelli ta' potassium, calcium u magnesium u ormon li jistimula t-tirojde fis-serum (TSH) u żmienijiet u sitwazzjonijiet meta għandhom isiru
English: • Vandetanib prolongs the QTc interval and can cause Torsades de Pointes and sudden death
Maltese: • Vandetanib itawwal l-intervall QTc u jista' jikkawża Torsades de Pointes u mewt f'daqqa
English: • Educational material for Healthcare Professionals
Maltese: • Materjal edukattiv għall-Professjonisti fil-Kura tas-Saħħa
English: • Patients who develop a single value of corrected ECG QTc interval of at least 500 msec should stop taking vandetanib.
Maltese: • Pazjenti li jiżviluppaw valur wieħed ta' QTc ta' mill-anqas 500 ms għandhom jieqfu jieħdu vandetanib.
English: • Who have a history of Torsades de Pointes unless all risk factors that contributed to Torsades have been corrected.
Maltese: • li fil-passat kellhom Torsades de Pointes sakemm ir-riskji kollha li kellhom sehem fit-Torsades ma jkunux ġew korretti.
English: • Details of medicinal products where the co-administration of vandetanib is either contraindicated or not recommended.
Maltese: • Dettalji tal-prodotti mediċinali fejn l-għotja ma' vandetanib hija jew kontraindikata jew mhux rakkomandata.
English: • Vandetanib treatment must not be started in patients:
Maltese: • Il-kura b'vandetanib m'għandhiex tinbeda f'pazjenti :
English: Brain MRI should be performed in any patient presenting with seizures, confusion or altered mental status.
Maltese: Għandu jsir MRI tal-moħħ fi kwalunkwe pazjent li jkollu aċċessjonijiet, konfużjoni jew stat mentali alterat.
English: • Who have congenital long QTc syndrome
Maltese: • li għandhom sindrome konġenita ta' QTc Twil
English: • If QTc increases markedly but stays below 500 msec, the advice of a cardiologist should be sought.
Maltese: • Jekk il-QTc jiżdied b'mod sostanzjali iżda jibqa taħt 500 ms, għandu jittieħed parir ta' kardjoloġist/a.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch and thereafter, all Healthcare Professionals who are expected to use and/or prescribe Caprelsa are provided with an Educational pack.
Maltese: Qabel ma joħroġ fis-suq il-prodott mediċinali f'kull Stat Membru, id-Detentur talAwtorizzazzjoni ser jiftiehem dwar il-kontenut u l-format tal-materjal edukattiv mal-awtorità nazzjonali kompetenti.
English: Dosing can be resumed at a reduced dose after return of the ECG QTc interval to pretreatment status has been confirmed and correction of possible electrolyte imbalance has been made.
Maltese: Id-dożaġġ jista' jerġa jinbeda b'doża mnaqqsa wara li jkun ġie kkonfermat li l-valur QTc tal-ECG reġa' niżel għall-istat ta' qabel il-kura u jkun sar aġġustament għall-iżbilanċ tal-elettroliti li seta' kien hemm.
English: 28 April 2014 EMA/276477/2014
Maltese: EMA/276477/2014
English: The review of methysergide was initiated on 24 May 2012 at the request of the French medicines agency ANSM under Article 31 of Directive 2001/83/EC following concerns about serious cases of fibrosis identified by the French agency.
Maltese: Ir-reviżjoni ta' methysergide inbdiet fl-24 ta' Mejju 2012 fuq it-talba tal-aġenzija tal-mediċini Franċiża ANSM skont l-Artikolu 31 tad-Direttiva 2001/83/KE wara tħassib dwar każijiet serji ta' fibrożi identifikati mill-aġenzija Franċiża.
English: Screening investigations may include heart ultrasound, abdominal MRI and lung function tests.
Maltese: Investigazzjonijiet ta' skrinjar jistgħu jinkludu ultrasound tal-qalb, MRI addominali u testijiet tal-funzjoni tal-pulmun.
English: Based on these data a potential causal association between methysergide and fibrosis seems likely.
Maltese: Abbażi ta' din id-dejta, assoċjazzjoni kawżali potenzjali bejn methysergide u fibrożi tidher li hija probabbli.
English: The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 28 April 2014.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li approvatha u ħarġet deċiżjoni finali li torbot legalment fit-28 ta' April 2014.
English: • Methysergide-containing medicines may cause a potentially serious condition known as fibrosis, in which scar tissue accumulates in some of the body's organs.
Maltese: • Mediċini li fihom methysergide jistgħu jikkawżaw kundizzjoni potenzjalment serja magħrufa bħala fibrożi, fejn tessut taċ-ċikatriċi jakkumula f'uħud mill-organi tal-ġisem.
English: Methysergide is a medicine that belongs to the class ‘ergot alkaloids' that has been used in the EU for preventing migraines (with or without aura) and other types of throbbing headaches.
Maltese: Methysergide huwa mediċina li tappartjeni għall-klassi ‘ergot alkaloids' li ntużat fl-UE għall-profilassi tal-emigranji (bi jew mingħajr awra) u tipi oħrajn ta' uġigħ ta' ras.
English: Previous treatment must have included treatment with medicines of at least 2 classes for a minimum of 2 months.
Maltese: Kuri preċedenti għandhom jinkludu kura b'mediċini ta' mill-inqas żewġ klassijiet għal minimu ta' xahrejn.
English: Treatment must be discontinued if symptoms of fibrosis occur.
Maltese: Il-kura għandha titwaqqaf jekk ikun hemm sintomi ta' fibrożi.
English: Previous treatment must have included treatment with medicines of other classes for at least 4 months at the maximum tolerated dose;
Maltese: Kuri preċedenti għandhom jinkludu kuri b'mediċini ta' klassijiet oħra għal tal-inqas 4 xhur bid-doża massima ttollerata;
English: • During treatment with methysergide, a treatment-free period of at least 4 weeks must be allowed between treatment courses at least every 6 months.
Maltese: • Matul il-kura b'methysergide, għandu jitħalla perjodu mingħajr kura ta' mill-inqas 4 ġimgħat bejn korsijiet ta' kura ta' mill-inqas kull 6 xhur.
English: − Prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults, when treatment with standard medicines has failed.
Maltese: − Kura profilattika ta' emigranja intrattabli (bi jew mingħajr awra) b'diżabilità funzjonali fl-adulti, meta kura b'mediċini normali ma tkunx irnexxiet.
English: On 20 February 2014, the European Medicines Agency recommended restricting the use of methysergide due to concerns that it could cause fibrosis, a condition in which fibrous (scar) tissue accumulates in the body's organs potentially damaging them.
Maltese: Fl-20 ta' Frar 2014, l-Aġenzija Ewropea għall-Mediċini rrakkomandat li jiġi limitat l-użu ta' methysergide minħabba tħassib li dan jista' jikkawża fibrożi, kundizzjoni li fiha, tessut fibruż (ċikatriċi) jakkumula florgani tal-ġisem u potenzjalment jagħmlilhom ħsara.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP), which conducted the review, noted that these recommendations were necessary due to the reports of fibrosis seen with methysergide and other medicines of the same class (ergot derivatives).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP) tal-Aġenzija, li mexxa din irreviżjoni, innota li dawn ir-rakkomandazzjonijiet kienu neċessarji minħabba rapporti ta' fibrożi li dehru b'methysergide u mediċini oħrajn tal-istess klassi (derivattivi ergot).
English: As a result of this, the use of these medicines is being restricted to the prevention of severe intractable migraines and cluster headaches when standard medicines have failed.
Maltese: B'riżultat ta' dan, l-użu ta' dawn il-mediċini qed jiġi limitat għall-prevenzjoni ta' emigranji severi intrattabli u uġigħ ta' ras f'naħa waħda tar-ras meta mediċini normali ma jkunux irnexxew.
English: The CHMP recommendations were sent to the European Commission, which has endorsed them and issued a final legally-binding decision that is valid throughout the EU.
Maltese: Ir-rakkomandazzjonijiet tas-CHMP intbagħtu lill-Kumissjoni Ewropea, li approvathom u ħarġet deċiżjoni finali li torbot legalment valida fl-UE.
English: The Agency's recommendations are based on available data on the benefits and risks of methysergide, from clinical studies, post-marketing safety reports and the scientific literature.
Maltese: Ir-rakkomandazzjonijiet tal-Aġenzija huma bbażati fuq dejta disponibbli fuq il-benefiċċji u r-riskji ta' methysergide, minn studji kliniċi, rapporti tas-sigurtà ta' wara t-tqegħid fis-suq u riċensjoni xjentifika.
English: • Following the review of methysergide-containing medicines, methysergide should now only be used for:
Maltese: • Wara r-reviżjoni ta' mediċini li fihom methysergide, methysergide għandu jintuża biss għal:
English: Patients should also be screened for fibrosis at the start of treatment and should have additional screenings every 6 months.
Maltese: Il-pazjenti għandhom ukoll jiġu eżaminati għal fibrożi fil-bidu tal-kura u għandu jsirilhom skrinjar addizzjonali kull 6 xhur.
English: The pharmaceutical forms and the approved indications, strengths and doses vary in different EU countries.
Maltese: L-għamliet farmaċewtiċi u l-indikazzjonijiet approvati, qawwa u dożi jvarjaw f'pajjiżi tal-UE differenti.
English: The symptoms of fibrosis often take some time to appear and without screening the diagnosis may come too late to prevent severe (and potentially life-threatening) damage to organs .
Maltese: Is-sintomi ta' fibrożi ħafna drabi jdumu ma jidhru u mingħajr skrinjar, id-dijanjożi tista' tasal tard wisq sabiex tiġi evitata ħsara severa (u potenzjalment fatali) għall-organi.
English: Regarding the benefits, the Committee noted that there is some evidence of a clinically relevant effect of methysergide when used for prevention in patients who regularly get migraines and cluster headaches and for whom treatment options are limited.
Maltese: Dwar il-benefiċċji, il-Kumitat innota li hemm xi evidenza ta' effetti ta' methysergide klinikament relevanti meta użat għall-prevenzjoni f'pazjenti li spiss ikollhom emigranji u uġigħ ta' ras f'naħa waħda tar-ras regolari u għal dawk li l-għażliet ta' kura għalihom huma limitati.
English: Once treatment is started the patient must be examined for occurrence of fibrosis at 6monthly intervals.
Maltese: Ladarba tkun inbdiet il-kura, il-pazjent għandu jiġi eżaminat għall-okkorrenza ta' fibrożi f'intervalli ta' 6 xhur.
English: In the EU, medicines containing methysergide have been authorised by national procedures and have been marketed under various trade names.
Maltese: Fl-UE, mediċini li fihom methysergide ġew awtorizzati minn proċeduri nazzjonali u tqiegħdu fis-suq b'diversi ismijiet.
English: It was also used to treat diarrhoea caused by carcinoid disease.
Maltese: Intużat ukoll biex titratta dijarea kkawżata minn mard karċinojde.
English: Methysergide has also been used for treating diarrhoea caused by carcinoid disease (a slow-growing tumour that commonly affects the gut).
Maltese: Methysergide intuża wkoll għall-kura ta' dijarea kkawżata minn mard karċinojde (tumur li jikber bil-mod li normalment jaffetwa lill-imsaren).
English: Intussusception
Maltese: Intussuxezzjoni
English: Device- and Procedure-Related Adverse Reactions Gastrointestinal disorders
Maltese: Relatati mal-Proċedura u tal-Apparat Disturbi gastrointestinali
English: • Inflamed colon (colitis).
Maltese: • Kolon infjammat (kolite).
English: (Applicable to bosutinib and ponatinib)
Maltese: (Applikabbli għal bosutinib u ponatinib)
English: DUODOPA (levodopa/carbidopa - intestinal gel)Intussusception (EPITT no 18424)
Maltese: DUODOPA (levodopa/carbidopa - ġell intestinali)Intussuxezzjoni (EPITT nru 18424)
English: (Applicable to imatinib, dasatinib and nilotinib)
Maltese: (Applikabbli għal imatinib, dasatinib u nilotinib)
English: Reported complications in the clinical studies, and seen post-marketing, include bezoar, ileus, implant site erosion/ulcer, intestinal haemorrhage, intestinal ischaemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumoperitoneum and post-operative wound infection.
Maltese: Kumplikazzjonijiet irrapurtati fl-istudji kliniċi, u li jidhru wara t-tqegħid fis-suq, jinkludu bezoar, ileus, erożjoni/ulċera tas-sit tal-impjant, emorraġija intestinali, iskemija intestinali, imblukkar intestinali, perforazzjoni intestinali, intussuxezzjoni, pankreatite, peritonite, pneumoperitoneum u infezzjoni ta' ġerħa ta' wara operazzjoni.
English: Side effects from the pump or tube
Maltese: Effetti sekondarji mill-pompa jew mit-tubu
English: LYSODREN (mitotane) - Sex hormone disturbances and development of ovarian macrocysts (EPITT no 18301)
Maltese: 3. LYSODREN (mitotane) - Disturbi fl-ormon sesswali u liżvilupp ta' makroċisti fl-ovarji (EPITT nru 18301)
English: Bcr-abl tyrosine kinase inhibitors: GLIVEC (imatinib); SPRYCEL (dasatinib); TASIGNA (nilotinib); BOSULIF (bosutinib); ICLUSIG (ponatinib) - Hepatitis B virus (HBV) reactivation (EPITT no 18405)
Maltese: Inibituri tat-tirożina kinażi Bcr-abl: GLIVEC (imatinib); SPRYCEL (dasatinib); TASIGNA (nilotinib); BOSULIF (bosutinib);
English: Adverse Reaction Data Derived From Clinical Trials and Postmarketing Experience Uncommon (> 1/1,000 to < 1/100)
Maltese: Mhux komuni (> 1/1,000 sa < 1/100)
English: Adopted at the 8-11 February 2016 PRAC
Maltese: Adottati fil-PRAC ta' bejn it-8 u l-11 ta' Frar 2016
English: Table 1 Tabulated summary of adverse reactions Infections and infestations
Maltese: Tabella 1 Reazzjonijiet avversi fil-qosor miġbura f'tabella Infezzjonijiet u infestazzjonijiet
English: Possible side effects - Recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Maltese: Effetti sekondarji possibbli - Rikorrenza (riattivazzjoni) tal-infezzjoni tal-epatite B meta kellek l-epatite B fil-passat (infezzjoni filfwied).