FrancophonIA/ELRC3.0 huggingface dataset:
English: When patients in the placebo treatment group were switched from placebo to TOBI Podhaler at the start of the second treatment cycle, they experienced a similar improvement from baseline in percent predicted FEV1.
Maltese: Meta l-pazjenti fil-grupp mogħti plaċebo qalbu minn plaċebo għal TOBI Podhaler fil-bidu tat-tieni ċiklu ta' kura, esperjenzaw titjib simili mil-linja bażi tal-perċentwali mbassra għal FEV1.
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Mylan EPD bvba/sprl Tél/Tel:
English: Other medicines and TOBI Podhaler
Maltese: Mediċini oħra u TOBI Podhaler
English: Clinical studies with inhaled tobramycin solution (TOBI) have shown a small increase in tobramycin, amikacin and gentamicin Minimum Inhibitory Concentrations for P. aeruginosa isolates tested.
Maltese: Studji kliniċi b'soluzzjoni ta' tobramycin meħuda man-nifs (TOBI) urew żieda żgħira fil-Konċentrazzjonijiet Inibitorji Minimi ta' tobramycin, amikacin u gentamicin għall-iżolati ta' P. aeruginosa ttestjati.
English: Mylan Products Ltd. Tel: +44 1707 853000
Maltese: Tel: +44 1707 853000
English: A majority of the patients were tobramycin-experienced adults with chronic pulmonary P. aeruginosa infection.
Maltese: Il-biċċa l-kbira tal-pazjenti kienu adulti b'infezzjoni pulmonari kronika b'P. aeruginosa u b'esperjenza ta' tobramycin.
English: See also “Monitoring of serum tobramycin concentrations” above.
Maltese: Ara wkoll is-sezzjoni “Monitoraġġ tal-konċentrazzjonijiet ta' tobramycin fis-serum” hawn taħt.
English: While the volume was shown to vary with body mass index (BMI) and lung function (as FEV1% predicted), model-based simulations showed that peak (Cmax) and trough (Ctrough) concentrations were not impacted markedly with changes in BMI or lung function.
Maltese: Filwaqt li ntwera li l-volum ivarja skont l-indiċi tal-piż tal-ġisem (BMI) u l-funzjoni tal-pulmun (bħala FEV1 mbassra), simulazzjonijiet ibbażati fuq mudell urew li l-konċentrazzjonijiet massimi (Cmax) u aktar baxxi (Ctrough) ma ħallewx daqstant impatt fit-tibdil tal-BMI jew fil-funzjoni tal-pulmun.
English: Adult patients tended to discontinue more frequently for tolerability reasons with TOBI Podhaler than with the nebuliser solution.
Maltese: Pazjenti adulti kellhom it-tendenza li frekwentament ma jkomplux b'TOBI Podhaler milli bis-soluzzjoni tan-nebulizzatur minħabba raġunijiet ta' tollerabbiltà.
English: When to take TOBI Podhaler
Maltese: META TIEĦU TOBI Podhaler
English: After this if the capsule is still full and appears to be unpunctured, replace the inhaler with the reserve inhaler and try again.
Maltese: Wara dan kollu, jekk il-kapsula tibqa' mimlija u tidher mhux imtaqqba, biddel l-inhaler mal-inhaler żejjed u erġa' pprova.
English: The improvement in percent predicted FEV1 was numerically greater in the TOBI Podhaler treatment group and was statistically non-inferior to TOBI nebuliser solution.
Maltese: It-titjib fil-perċentwali mbassra għal FEV1 kienet numerikament akbar fil-grupp ta' kura b'TOBI Podhaler u ma kenitx statistikament inferjuri għal soluzzjoni b'nebulizzatur TOBI.
English: Based upon in vitro data and/or clinical trial experience, the organisms associated with pulmonary infections in CF may be expected to respond to TOBI Podhaler therapy as follows:
Maltese: Skont l-informazzjoni u/jew l-esperjenza waqt il-prova klinika in vitro, l-organiżmi assoċjati ma' infezzjonijiet pulmonari f'fibroża ċistika jista' jiġri li jirrispondu għat-terapija b'TOBI Podhaler kif ġej:
English: If there is evidence of continued therapy-induced cough with TOBI Podhaler, the physician should consider whether an approved tobramycin nebuliser solution should be used as an alternative treatment.
Maltese: Jekk hemm evidenza li t-terapija b'TOBI Podhaler qed twassal għal sogħla kontinwa, it-tabib għandu jikkunsidra jekk għandhiex tintuża soluzzjoni approvata ta' tobramycin b'nebulizzatur bħala kura alternattiva.
English: In the active-controlled study, at least 89% of patients had P. aeruginosa isolates with MICs at least 15 times lower than mean post-dose sputum concentration, both at baseline and at the end of the third active treatment cycle.
Maltese: Fl-istudju kkontrollat bl-attiv, mill-inqas 89% tal-pazjenti kellhom P. aeruginosa b'dik ta' MIC mill-inqas 15 -il darba iktar baxxa mill-konċentrazzjoni medja ta' wara l-isputum, kemm fillinja bażi kif ukoll fit-tmiem tat-tielet ċiklu ta' kura attiva.
English: The Podhaler inhalation device and its storage case are made from plastic materials (polypropylene).
Maltese: L-inhaler Podhaler u l-kontenitur fejn jintrefa' huma magħmulin minn materjal tal-plastik (polipropilena).
English: This analysis did not show gender or age-related pharmacokinetic differences
Maltese: Din l-analiżi ma writx differenzi farmakokinetiċi relatati mas-sess jew l-età.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Nasal congestion
Maltese: Nefrotossiċità
English: EU/1/10/652/001-003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/652/001-003
English: This includes monitoring of serum concentrations of tobramycin.
Maltese: Dan jinkludi monitoraġġ tal-konċentrazzjonijiet ta' tobramycin fis-serum.
English: Established susceptibility breakpoints for parenteral administration of tobramycin are inappropriate in the aerosolised administration of the medicinal product.
Maltese: Breakpoints stabbiliti ta' suxxetibilità għal amministrazzjoni parenterali ta' tobramycin m'humiex adegwati fl-għoti bl-ajrusol tal-prodott mediċinali.
English: Musculoskeletal chest pain
Maltese: Effetti mhux mixtieqa
English: Take TOBI Podhaler twice a day, every day for 28 days
Maltese: Ħu TOBI Podhaler man-nifs darbtejn kuljum, kuljum għal 28 jum
English: The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy.
Maltese: L-iżvilupp ta' P. aeruginosa reżistenti għall-antibijotiċi u ta' superinfezzjoni ma' patoġeni oħrajn jirrappreżentaw riskji qawwija asoċjati ma' terapija antibjotika.
English: Bronchospasm
Maltese: Suxxettibbli
English: Concomitant use of TOBI Podhaler with diuretic compounds (such as ethacrynic acid, furosemide, urea or intravenous mannitol) is not recommended.
Maltese: L-użu flimkien ta' TOBI Podhaler ma' komponenti dijuretiċi (bħalma huma aċidu etakriniku, furosemide, urea jew mannitol mogħti fil-vina) mhuwiex irrakkomandat.
English: monthly multipack
Maltese: Il-qisien tal-pakketti
English: Each weekly carton contains 7 blisters (capsule cards) of 8 capsules each, and a Podhaler device in its storage case.
Maltese: Kull kartuna għal ġimgħa fiha 7 folji (folji bil-kapsuli) ta' 8 kapsuli kull waħda, u inhaler Podhaler merfugħ fil-kontenitur tiegħu.
English: EMA/60300/2014 EMEA/H/C/002713
Maltese: EMEA/H/C/002713
English: The full EPAR and risk management plan summary for Latuda 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: The active substance in Latuda, lurasidone, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Latuda, lurasidone, hija mediċina antipsikotika.
English: This is a summary of the European public assessment report (EPAR) for Latuda.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Latuda.
English: Other information about Latuda
Maltese: Informazzjoni oħra dwar Latuda
English: Latuda is a medicine that contains the active substance lurasidone.
Maltese: Latuda huwa mediċina li fiha s-sustanza attiva lurasidone.
English: Latuda is available as tablets (18.5, 37 and 74 mg) and can only be obtained with a prescription.
Maltese: Latuda jiġi bħala pilloli(18.5, 37 u 74 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Latuda has been investigated in six main studies.
Maltese: Latuda ġie investigat f'sitt studji prinċipali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Latuda on 21 March 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Latuda fil-21 ta' Marzu 2014.
English: Lurasidone acts mainly by blocking the receptors for the neurotransmitters dopamine, 5hydroxytryptamine (also called serotonin) and noradrenaline.
Maltese: Lurasidone jaġixxi prinċipalment billi jimblokka lir-riċetturi tan-newrotransmittur dopamine, 5hydroxytryptamine(imsejjaħ ukoll serotonin) u noradrenaline.
English: Why is Latuda approved?
Maltese: Għaliex ġie approvat Latuda?
English: Since dopamine, 5-hydroxytryptamine and noradrenaline play a role in schizophrenia, by blocking their receptors lurasidone helps to normalise the activity of the brain, reducing symptoms.
Maltese: Peress li dopamine, 5hydroxytryptamine u noradrenaline għandhom rwol fi skizofrenija, billi jimblokka lir-riċetturi tagħhom, lurasidone jgħin billi jinnormalizza l-attività tal-moħħ, allura jnaqqas is-sintomi.
English: Three short-term studies compared Latuda with placebo (a dummy treatment) over six weeks in a total of 1,466 patients.
Maltese: Tliet studji qosra qabblu Latuda ma' plaċebo (kura finta) fuq perjodu ta' sitt ġimgħat f'total ta' 1,466 pazjent.
English: One of the short-term studies was continued to 12 months (extension study) to look at the maintenance of the effect of Latuda in 292 patients, compared with quetiapine; two other studies, involving 914 patients, looked at the long-term effects of Latuda compared with another schizophrenia medicine, risperidone, or placebo, respectively.
Maltese: Wieħed mill-istudji fuq perjodu ta' żmien qasir tkompla sa 12-il xahar (studju ta' estensjoni) sabiex jistudja ż-żamma tal-effett ta' Latuda f'292 pazjent, meta mqabbel ma' quetiapine; żewġ studji oħra, li involvew 914-il pazjent, ħarsu lejn l-effetti fit-tul ta' Latuda meta mqabbla ma' mediċina oħra għalliskiżofrenja, risperidone, jew plaċebo, rispettivament.
English: Latuda must not be used together with medicines known as ‘strong CYP3A4 inhibitors' or ‘strong CYP3A4 inducers', which may affect the levels of lurasidone in the blood.
Maltese: Latuda m'għandux jintuża flimkien ma' mediċini magħrufa bħala ‘inibituri qawwija ta' CYP3A4' jew indutturi qawwija ta' CYP3A4', li jistgħu jaffettwaw il-livelli ta' lurasidone fid-demm.
English: The last study showed that 30% of patients treated with Latuda relapsed within one year, compared with 41% of patients treated with placebo.
Maltese: L-aħħar studju wera li 30% tal-pazjenti kkurati b'Latuda rkadew fi żmien sena, meta mqabbel ma' 41% tal-pazjenti kkurati bi placebo.
English: Regarding safety, the side effects of Latuda were considered similar to those of other medicines of the same type, but it seemed to have fewer effects on body metabolism (such as effects on blood levels of sugar and fat, and body weight) and might have less effect on the activity of the heart than some other available treatments.
Maltese: Fir-rigward tas-sigurtà, l-effetti sekondarji ta' Latuda tqiesu li huma simili għal dawk ta' mediċini oħrajn tal-istess tip, iżda deher li kellu inqas effetti fuq il-metaboliżmu tal-bniedem (bħal effetti fuq il-livelli taz-zokkor u xaħam fid-demm u piż tal-ġisem) u jista' jkollu inqas effett fuq l-attività tal-qalb minn xi kura oħra disponibbli.
English: It is used to treat adults with schizophrenia, a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Maltese: Tintuża sabiex tikkura adulti bl-iskizofrenija, marda mentali li għandha għadd ta' sintomi li jinkludu ħsibijiet u diskors disorganizzati, alluċinazzjonijiet (tisma' u tara affarijiet li ma jkunux hemm), suspetti u delużjonijiet (twemmin żbaljat).
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Maltese: Newrotrasmettituri huma kimiċi li jħallu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: Latuda was not shown to be as effective as risperidone in the second study, although the available data supported a long-term benefit.
Maltese: Latuda intwera li mhuwiex effettiv daqs risperidone fit-tieni studju, għalkemm l-informazzjoni disponibbli appoġġat benefiċċju fit-tul.
English: In the extension study, 21% of patients treated with Latuda had a relapse within one year, compared with 27% of patients treated with quetiapine, showing that Latuda was at least as effective as quetiapine.
Maltese: Fl-istudju ta' estensjoni, 21% tal-pazjenti kkurati b'Latuda rkadew fi żmien sena, meta mqabbel ma' 27% tal-pazjenti kkurati b'quetiapine.
English: In these studies, different doses of Latuda were shown to be more effective than placebo, lowering the PANSS score by up to 16 points more than placebo; however, this effect was not consistently demonstrated for each dose and it was not possible to observe a consistent dose-response relationship.
Maltese: F'dawn l-istudji, id-dożi differenti ta' Latuda dehru li kienu aktar effettivi millplaċebo, tnaqqis fil-punteġġ PANSS sa 16-il punt aktar minn plaċebo; madankollu, dan l-effett ma ntweriex b'mod konstanti għal kull doża u ma kienx possibbli li tiġi osservata relazzjoni konsistenti bejn id-doża u r-reazzjoni.
English: How does Latuda work?
Maltese: Kif taħdem Latuda?
English: The most common side effects with Latuda (which may affect more than 1 in 10 people) are akathisia (a constant urge to move) and somnolence (sleepiness).
Maltese: L-effetti sekondarji l-aktar komuni b'Latuda (li jistgħu jaffettwaw lil aktar minn persuna 1 f'10) huma akatisija (ħeġġa kostanti biex jiċċaqalqu) u ngħas.
English: The main measure of effectiveness was the change in the patient's symptoms, measured using a standard scale for schizophrenia called ‘positive and negative syndrome scale' (PANSS).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fis-sintomi talpazjent, imkejla bl-użu ta' skala standard għall-iskiżofrenija imsejħa "skala tas-sindromu pożittiva u negattiva" (PANSS).
English: EMA/629905/2014 EMEA/H/C/000235
Maltese: EMEA/H/C/000235
English: The full EPAR for Arava 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: It is available as tablets (10, 20 and 100 mg).
Maltese: Jiġi f'għamla ta' pilloli (10, 20 u 100 mg).
English: severe immunodeficiency states, such as acquired immune deficiency syndrome (AIDS);
Maltese: stati ta' immunodefiċjenza gravi, bħas-sindromu tal-immudodefiċjenza miksuba (AIDS);
English: The most common side effects with Arava (seen in between 1 and 10 patients in 100) are leucopenia (low white blood cell counts), mild allergic reactions, increased creatine phosphokinase levels (a marker of muscle damage), paraesthesia (abnormal sensations like pins and needles), peripheral neuropathy (nerve damage in hands and feet), headache, dizziness, mild increases in blood pressure, diarrhoea, nausea (feeling sick), vomiting, inflammation of the mouth such as mouth ulcers, abdominal pain (stomach ache), increased liver enzyme levels, hair loss, eczema, rash, pruritus (itching), dry skin, tenosynovitis (inflammation of the sheath surrounding the tendons), loss of appetite, weight loss and asthenia (weakness).
Maltese: L-iktar effetti sekondarji komuni ma' Arava (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma llewkopenija (għadd baxx ta' ċelloli tad-demm bojod), reazzjonijiet allerġiċi ħfief, livelli ogħla ta' kreatina fosfokinażi (indikatur ta' ħsara fil-muskoli), parestesija (sensazzjonijiet anomali fil-ġilda bħal tingiż jew tnemnim), newropatija periferali (ħsara fin-nervituri tal-idejn u s-saqajn), uġigħ ta' ras, sturdament, żieda ħafifa fil-pressjoni, dijarrea, nawżea (dardir), rimettar, infjammazzjoni tal-ħalq bħal ulċeri talħalq, uġigħ addominali (fiż-żaqq), żieda fil-livelli tal-enzimi tal-fwied, telf ta' xagħar, ekzema, raxx, ħakk, ġilda niexfa, tenosinovite (infjammazzjoni tal-kisi ta' madwar it-tendini), telf tal-aptit, telf ta' piż u astenija (dgħufija).
English: The active substance in Arava, leflunomide, is an immunosuppressant.
Maltese: Is-sustanza attiva f'Arava, leflunomide, hija mediċina immunosuppressiva.
English: Arava is a medicine that contains the active substance leflunomide.
Maltese: Arava huwa mediċina li fiha s-sustanza attiva leflunomide.
English: This is a summary of the European public assessment report (EPAR) for Arava.
Maltese: Dan id-dokument huwa sommarju tar-rapport ta' valutazzjoni pubblika Ewropew (EPAR) għal Arava.
English: Between 49 and 55% of the patients taking Arava responded to treatment, compared with 26 to 28% of those taking placebo, and 54% of those taking sulphasalazine.
Maltese: Bejn 49 u 55% tal-pazjenti li ħadu Arava rrispondew għat-trattament, meta mqabbel ma' 26 u 28% ta' dawk li kienu qegħdin jieħdu l-plaċebo u 54% li kienu qegħdin jieħdu sulphasalazine.
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Maltese: Id-doża ta' manutenzjoni rakkomandata hija 10 sa 20 mg darba kuljum f'pazjenti b'artrite rewmatika, u 20 mg darba kuljum f'pazjenti b'artrite psorjatika.
English: In psoriatic arthritis, Arava was more effective than placebo, with 59% of the patients taking Arava responding to treatment, compared with 30% of those taking placebo.
Maltese: Fl-artrite psorjatika, Arava kien iktar effikaċi mill-plaċebo, b'59% tal-pazjenti li ħadu Arava jirrispondu għat-trattament, meta mqabbel ma' 30% ta' dawk li ħadu l-plaċebo.
English: Why has Arava been approved?
Maltese: Għaliex ġie approvat Arava?
English: What is Arava?
Maltese: X'inhu Arava?
English: Arava treatment usually starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Maltese: It-trattament b'Arava jibda b'‘doża inizjali' ta' 100 mg darba kuljum għal tlett ijiem, segwiti b'doża ta' manutenzjoni.
English: A risk management plan has been developed to ensure that Arava is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Arava jintuża bl-aktar mod sigur possibbli.
English: Doctors prescribing Arava need to be aware of the risk of liver problems associated with the medicine.
Maltese: It-tobba li jippreskrivu Arava għandhom ikunu konxji mir-riskju ta' problemi bil-fwied assoċjati ma' din il-mediċina.
English: In psoriatic arthritis, Arava has been compared with placebo in 186 patients over six months.
Maltese: Fl-artrite psorjatika, Arava tqabbel ma' plaċebo f'186 pazjent fuq sitt xhur.
English: Arava is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Maltese: Arava jintuża għat-trattament ta' adulti bl-artrite rewmatojde (marda tas-sistema immunitarja li tikkawża infjammazzjoni tal-ġogi) jew bl-artrite psorjatika attiva (marda li tikkawża dbabar ħomor bilqoxra fil-ġilda u infjammazzjoni tal-ġogi).
English: In rheumatoid arthritis, Arava has been studied in four main studies involving over 2,000 patients, in which it was compared with placebo (a dummy treatment), or with methotrexate or sulphasalazine (other medicines used to treat rheumatoid arthritis).
Maltese: Fl-artrite rewmatojde, Arav ġie studjat f'erba' studji ewlenin li kienu jinvolvu 2,000 pazjent, fejn tqabbel ma' plaċebo (trattament finta), jew ma' methotrexate jew sulphasalazine (mediċini oħra użati fit-trattament ta' artrite rewmatojde).
English: In rheumatoid arthritis, Arava was more effective than placebo and as effective as sulphasalazine.
Maltese: Fl-artrite rewmatojde, Arava kien iktar effikaċi mill-plaċebo u effikaċi daqs sulphasalazine.
English: In all of the studies, the main measure of effectiveness was the number of patients who responded to treatment, as defined by disease-specific criteria (American College of Rheumatology response rates for rheumatoid arthritis, and the Psoriatic Arthritis treatment Response Criteria for psoriatic arthritis).
Maltese: F'dawn l-istudji kollha, il-miżura ewlenija tal-effikaċja kienet in-numru ta' pazjenti li wieġbu għall-kura, kif definit mill-kriterji speċifiċi tal-marda (rati ta' rispons tal-American College of Rheumatology għal artrite rewmatojde, u l-Kriterji ta' Rispons għall-kura għall-Artrite Psorjatika fuq l-artrite psorjatika).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Arava on 2 September 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Arava valida fl-Unjoni Ewropea kollha fit-2 ta' Settembru 1999.
English: In addition, the company that markets Arava will ensure that doctors who are expected to prescribe the medicine receive an information pack containing important information on the risks with Arava and the monitoring that should be carried out in patients.
Maltese: Barra minn hekk, il-kumpanija li timmanifattura Arava ser tiżgura li t-tobba li mistennija jippreskrivu lmediċina għandhom jirċievu pakkett ta' informazzjoni li fih informazzjoni importanti dwar ir-riskji ta' Arava u l-monitoraġġ li għandu jsir fuq il-pazjenti.
English: What is the risk associated with Arava?
Maltese: Għal xiex jintuża Arava?
English: How has Arava been studied?
Maltese: Kif ġie studjat Arava?
English: Over the first year of treatment, Arava was as effective as methotrexate, but only when it was taken with folate (a type of vitamin B).
Maltese: Matul l-ewwel sena ta' trattament, Arava kien effikaċi daqs methotrexate, iżda biss meta ttieħed ma' folate (tip ta' vitamina B).
English: liver disease;
Maltese: mard tal-fwied;
English: Arava treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Maltese: It-trattament b'Arava għandu jinbeda u jiġi sorveljat minn speċjalista li jkollu esperjenza fit-trattament tal-artrite rewmatojde u l-artrite psorjatika.
English: Arava was not as effective as methotrexate in the extension study.
Maltese: Arava ma kienx effikaċi daqs methotrexate fl-istudju ta' estensjoni.
English: The CHMP decided that Arava's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Arava huma akbar mir-riskji tiegħu u rrakomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Arava must not be used in people who may be hypersensitive (allergic) to leflunomide, to teriflunomide (a breakdown product of leflunomide) or to any of the other ingredients.
Maltese: Arava ma għandux jintuża fuq persuni li huma ipersensittivi (allerġiċi) għal leflunomide, għal teriflunomide (prodott li jirriżulta wara t-tkissir tal-leflunomide) jew għal xi sustanzi oħra tiegħu.
English: Infections including opportunistic infections
Maltese: Infezzjonijiet inklużi infezzjonijiet opportunistiċi
English: Tacrolimus systemic formulation - Hepatitis E infection (EPITT no 19246)
Maltese: 1. Formulazzjoni sistemika ta' Tacrolimus - infezzjoni talEpatite E (EPITT nru 19246)
English: Adopted at the 29-31 October 2018 PRAC
Maltese: Adottata fil-PRAC ta' bejn il-29-31 ta' Ottubru 2018
English: Xylometazoline - Serious ventricular arrhythmia in patients with long QT syndrome (EPITT no 19242)
Maltese: Xylometazoline - Aritmija ventrikolari serja f'pazjenti bissindromu ta' QT twila (EPITT nru 19242)
English: Patients are also at an increased risk of infections with viral hepatitis (for example, hepatitis B and C reactivation and de novo infection, as well as hepatitis E, which may become chronic).
Maltese: Il-Pazjenti huma wkoll f'riskju akbar ta' infezzjonijiet b'epatite virali (pereżempju, ir-riattivazzjoni tal-epatite B u C u infezzjoni de novo, kif ukoll l-epatite E, li jistgħu jsiru kroniċi).