FrancophonIA/ELRC3.0 huggingface dataset:
English: This causes a wide range of symptoms, including impaired vision, weak bones and circulatory problems.
Maltese: Dan jikkawża firxa wiesgħa ta' sintomi inkluż indeboliment fil-vista, għadam dgħajjef u problemi fis-sistema ċirkolatorja.
English: Patients with symptoms of cerebral oedema, such as morning headaches with vomiting, or changes in vision, should speak to their doctor, as treatment with Cystadane may have to be interrupted.
Maltese: Il-pazjenti b'sintomi ta' edema ċerebrali, bħal uġigħ ta' ras filgħodu bir-remettar, jew tibdil fil-vista għandhom jitkellmu mat-tabib tagħhom, peress li l-kura b'Cystadane jaf ikollha tiġi interrotta.
English: It should be dissolved fully in water, juice, milk, formula or food immediately before being taken.
Maltese: Dan għandu jinħall kompletament fl-ilma, fil-meraq, fil-ħalib, fil-formula jew fl-ikel minnufih qabel jittieħed.
English: How is Cystadane used?
Maltese: Kif jintuża Cystadane?
English: Treatment with Cystadane should be supervised by a doctor who has experience in the treatment of patients with homocystinuria.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Cystadane.
English: The full EPAR for Bridion 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: Other information about Bridion
Maltese: Informazzjoni oħra ieħor dwar Bridion
English: Bridion is a solution for injection that contains the active substance sugammadex (100 mg/ml).
Maltese: Bridion huwa soluzzjoni għall-injezzjoni li fih is-sustanza attiva sugammadex (100 mg/ml).
English: The active substance in Bridion, sugammadex, is a ‘selective relaxant binding agent'.
Maltese: Is-sustanza attiva fi Bridion, is-sugammadex, hija ‘aġent leganti rilassant selettiv'.
English: This is a summary of the European public assessment report (EPAR) for Bridion.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Bridion.
English: After moderate muscle relaxation, the average time for recovery was between 1.4 and 2.1 minutes for 2 mg/kg Bridion, compared with 17.6 to 18.9 minutes for neostigmine.
Maltese: Wara rilassament tal-muskoli moderat, il-ħin medju tal-irkupru kien bejn 1.4 u 2.1 minuti b'2 mg/kg Bridion, meta mqabbel ma' bejn 17.6 u 18.9 minuti bin-neostigmina.
English: Bridion has been studied in four main studies in a total of 579 adults undergoing surgery using muscle relaxants.
Maltese: Bridion ġie studjat f'erba' studji f'total ta' 579 adult li kien qed isirilhom intervent kirurġiku birrilassanti muskolari.
English: Bridion is used to reverse the effect of the muscle relaxants rocuronium and vecuronium.
Maltese: Bridion jintuża biex ireġġa' lura l-effetti tar-rilassanti muskolari rokuronju u vekuronju.
English: This dose is expected to be used in only a limited number of the treatments (less than 1%).
Maltese: Din id-doża mistennija tintuża biss f'għadd limitat ta' każi ta' kura (inqas minn 1%).
English: In children and adolescents from two to 17 years of age, the recommended dose is 2 mg/kg body weight.
Maltese: Għat-tfal u l-adoloxxenti minn sentejn sa 17-il sena, id-doża rakkomandata hija 2 mg/kg tal-piż talġisem.
English: The most common side effects with Bridion (seen in between 1 and 10 patients in 100) are cough, airway problems due to the anaesthesia wearing off, reduced blood pressure and other complications such as changes in heart rate.
Maltese: L-effetti sekondarji l-aktar komuni bi Bridion (li dehru f'bejn pazjent 1 u 10 minn 100) kienu s-sogħla, problemi fil-pajpijiet tan-nifs minħabba t-tmiem tal-effett tal-anestesija, pressjoni tad-demm imnaqqsa u komplikazzjonijiet oħrajn bħat-tibdil fir-rata tal-qalb.
English: Why has Bridion been approved?
Maltese: Għaliex ġie approvat Bridion?
English: After deep muscle relaxation, recovery took an average of around 3.0 minutes with 4 mg/kg Bridion, compared with around 49.5 minutes for neostigmine.
Maltese: Wara rilassament tal-muskoli profond, l-irkupru dam medja ta' madwar 3.0 minuti b'4 mg/kg Bridion, meta mqabbel ma' madwar 49.5 minuti bin-neostigmina.
English: A risk management plan has been developed to ensure that Bridion is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Bridion jintuża bl-aktar mod sigur possibbli.
English: What is the risk associated with Bridion?
Maltese: X'inhu r-riskju assoċjat ma' Bridion?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bridion on 25 July 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Bridion valida fl-Unjoni Ewropea kollha fil-25 ta' Lulju 2008.
English: Two of the studies, involving a total of 282 patients, looked at the effectiveness of 2 mg/kg Bridion in reversing moderate relaxation of the muscles due to rocuronium or vecuronium.
Maltese: Tnejn mill-istudji, li involvew b'kollox 282 pazjent, stħarrġu l-effikaċja tal-għoti ta' 2 mg/kg Bridion għat-treġġigħ lura ta' rilassament moderat tal-muskoli kkaġunat mir-rokuronju jew mill-vekuronju.
English: Muscle relaxants make it easier for the surgeon to do the operation.
Maltese: Ir-rilassanti muskolari jgħinu l-kirurgi jagħmlu l-operazzjoni b'mod iżjed faċli.
English: In contrast, muscle relaxation recovered spontaneously after 7.1 minutes.
Maltese: B'kuntrast ma' dan, ir-rilassament muskolari rkupra b'mod spontanju wara 7.1 minuti.
English: What is Bridion?
Maltese: X'inhu Bridion?
English: Bridion can be used in adults who have received rocuronium and vecuronium, and in children and adolescents who have received rocuronium.
Maltese: Bridion jista' jintuża fuq adulti li jkunu ngħataw ir-rokuronju u l-vekuronju, u fuq tfal u adoloxxenti li jkunu ngħataw ir-rokuronju.
English: Bridion was compared with neostigmine (another medicine used to stop the effect of muscle relaxants) given after rocuronium or vecuronium in the first study and after cis-atracurium (another muscle relaxant) in the second.
Maltese: Bridion tqabbel mal-għoti tan-neostigmina (mediċina oħra użata biex twaqqaf l-effett tar-rilassanti muskolari) wara l-għoti tar-rokuronju jew tal-vekuronju fl-ewwel studju, u fit-tieni studju wara l-għoti taċ-ċisatrakurju (rilassant muskolari ieħor).
English: An additional study looked at the effectiveness of Bridion given after rocuronium in 90 children and adolescents.
Maltese: Studju ieħor stħarreġ l-effikaċja ta' Bridion mogħti wara r-rokuronju fuq 90 tifel u tifla u adoloxxenti.
English: The third study compared the effectiveness of 4 mg/kg Bridion with that of neostigmine after deep relaxation of the muscles using rocuronium or vecuronium in 182 patients.
Maltese: It-tielet studju qabbel l-effikaċja ta' 4 mg/kg Bridion maleffikaċja tan-neostigmina wara rilassament fil-fond tal-muskoli bl-użu tar-rokuronju jew tal-vekuronju f'182 pazjent.
English: The fourth study, involving 115 patients, looked at the effectiveness of 16 mg/kg Bridion in producing rapid reversal of the muscle relaxation using rocuronium.
Maltese: Ir-raba' studju, li sar fuq 115-il pazjent, stħarreġ l-effikaċja ta' 16 mg/kg Bridion fil-ksib ta' treġġigħ lura mgħaġġel mir-rilassament muskolari bl-użu tar-rokuronju.
English: How has Bridion been studied?
Maltese: Kif ġie studjat Bridion?
English: The standard dose of Bridion is between 2 and 4 mg per kilogram body weight, depending on how much the muscle relaxant is affecting the muscles.
Maltese: Id-doża standard ta' Bridion hija bejn 2 u 4 mg għal kull kilogramma tal-piż tal-ġisem, dejjem skont kif irrilassant muskolari jkun qed jaffettwa l-muskoli.
English: The effect of Bridion seen in adults was similar in adolescents and children aged over two years.
Maltese: L-effett ta' Bridion irreġistrat fl-adulti kien simili għal dak fl-adoloxxenti u fit-tfal minn sentejn ‘il fuq.
English: How does Bridion work?
Maltese: Għal xiex jintuża Bridion?
English: Bridion was more effective than neostigmine in reducing the time it took for the muscles to recover, after both moderate and deep muscle relaxation using rocuronium or vecuronium.
Maltese: Bridion kien iżjed effikaċi min-neostigmina fit-tnaqqis ta' kemm damu il-muskoli biex jirkupraw, wara rilassament tal-muskoli kemm moderat u kemm profond bl-użu tar-rokuronju jew tal-vekuronju.
English: Bridion can only be given by or under the supervision of an anaesthetist (a doctor specialised in anaesthesia).
Maltese: Bridion għandu jingħata biss minn anestetista (tabib speċjalizzat fl-anestesija) jew taħt is-superviżjoni tiegħu.
English: The CHMP decided that Bridion's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Bridion huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: This was compared with spontaneous recovery after muscle relaxation using succinylcholine (another muscle relaxant).
Maltese: Dan tqabbel ma' rkupru spontanju wara rilassament muskolari bl-użu tas-suċċinilkolina (rilassant muskolari ieħor).
English: As a result, the effect of blockade of the muscles due to rocuronium and vecuronium on the muscles is reversed, and the muscles begin to work normally again, including the muscles that help the patient to breathe.
Maltese: Għaldaqstant, l-effett tal-imblokk tal-muskoli, ikkaġunat mir-rokuronju u l-vekuronju fil-muskoli, jitreġġa' lura u l-muskoli jerġgħu jibdew jaħdmu bħas-soltu, anke dawk li jgħinu lill-pazjenti jieħdu n-nifs.
English: Further information on Segluromet 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: Segluromet is available as tablets in 4 strengths of ertugliflozin and metformin (2.5 mg/850 mg, 2.5 mg/1,000 mg, 7.5 mg/850 mg and 7.5 mg/1,000 mg).
Maltese: Segluromet jiġi bħala pilloli f'4 qawwiet ta' ertugliflozin u metformina (2.5 mg/850 mg, 2.5 mg/1,000 mg, 7.5 mg/850 mg u 7.5 mg/1,000 mg).
English: Segluromet (ertugliflozin / metformin hydrochloride)
Maltese: Segluromet (ertugliflozin / metformina kloridrata)
English: Other information about Segluromet
Maltese: Informazzjoni oħra dwar Segluromet
English: In this study, HbA1c levels fell by 0.6 points with ertugliflozin and 0.7 points with glimepiride.
Maltese: F'dan listudju, il-livelli ta' HbA1c naqsu b'0.6 punti b'ertugliflozin u b'0.7 punti b'glimepiride.
English: What are the risks associated with Segluromet?
Maltese: X'inhuma r-riskji assoċjati ma' Segluromet?
English: • The first study found that in patients taking a combination of ertugliflozin and metformin, HbA1c levels fell by around 0.8 points, compared with reductions of 0.03 when placebo (a dummy treatment) was added to metformin.
Maltese: • L-ewwel studju sab li f'pazjenti li kienu qegħdin jieħdu kombinazzjoni ta' ertugliflozin u metformina, il-livelli ta' HbA1c naqsu b'madwar 0.8 punti, meta mqabbel ma' tnaqqis ta' 0.03 meta l-plaċebo (kura finta) żdied mal-metmorfina.
English: • A third study found that a combination of ertugliflozin at a 15 mg dose with metformin was about as effective as a combination of metformin with another diabetes medicine, glimepiride.
Maltese: • It-tielet studju sab li kombinazzjoni ta' ertugliflozin b'doża ta' 15 mg mal-metformina kienet kważi effettiva daqs kombinazzjoni ta' metmorfina ma' mediċina tad-dijabete oħra, glimepiride.
English: Segluromet contains two active substances, ertugliflozin and metformin.
Maltese: Segluromet fih żewġ sustanzi attivi, ertugliflozin u metformina.
English: HbA1c levels fell by between 0.8 and 0.9 percentage points when ertugliflozin was added, compared with a fall of 0.1 with placebo
Maltese: Il-livelli ta' HbA1c naqsu b'bejn 0.8 u 0.9 punti perċentwali meta żdied ertugliflozin, meta mqabbel ma' tnaqqis ta' 0.1 bil-plaċebo.
English: • patients who are already taking ertugliflozin and metformin as separate tablets.
Maltese: • pazjenti li diġà qegħdin jieħdu l-ertugliflozin u l-metformina bħala pilloli separati.
English: The most common side effects with Segluromet (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system and problems with the gut such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.
Maltese: L-effetti sekondarji l-aktar komuni b'Segluromet (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet fungali tal-vaġina u infezzjonijiet oħra tas-sistema riproduttiva tal-mara u problemi bl-imsaren bħal nawżja, rimettar, dijarea, uġigħ addominali u telf ta' aptit.
English: As for all medicines, data on the use of Segluromet is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Segluromet hija ssorveljata kontinwament.
English: The two active substances in Segluromet, ertugliflozin and metformin, work in different ways to lower glucose levels.
Maltese: Iż-żewġ sustanzi attivi f'Segluromet, l-ertugliflozin u l-metformina, jaħdmu b'modi differenti biex ibaxxu l-livelli tal-glukożju.
English: • A second study found that adding ertugliflozin to a combination of sitagliptin (another diabetes medicine) and metformin was more effective than placebo.
Maltese: • It-tieni studju sab li ż-żieda ta' ertugliflozin ma' kombinazzjoni ta' sitagliptin (mediċina tad-dijabete oħra) u metmorfina kienet aktar effettiva mill-plaċebo.
English: Segluromet is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes.
Maltese: Segluromet huwa mediċina li tintuża biex tikkontrolla l-livelli tal-glukożju (taz-zokkor) fid-demm f'adulti b'dijabete tat-tip 2.
English: How is Segluromet used?
Maltese: Segluromet?
English: How does Segluromet work?
Maltese: Kif jaħdem Segluromet?
English: Side effects reported with Segluromet are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati b'Segluromet huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The strength of Segluromet tablet to use depends on how well the patient's glucose levels are controlled.
Maltese: Il-qawwa tal-pillola Segluromet li għandha tintuża tiddependi minn kemm jiġu kkontrollati l-livelli talglukożju tal-pazjent.
English: Uptravi is available as tablets (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms).
Maltese: Uptravi huwa disponibbli bħala pilloli (200; 400; 600; 800; 1,000; 1,200; 1,400 u 1,600 mikrogramma).
English: The full EPAR for Uptravi 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 European Commission granted a marketing authorisation valid throughout the European Union for Uptravi on 12 May 2016.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Uptravi valida fl-Unjoni Ewropea kollha fit-12 ta' Mejju 2016.
English: The ‘class' reflects the severity of the disease: ‘class II' involves slight limitation of physical activity while ‘class III' involves marked limitation of physical activity.
Maltese: Il-“klassi” tirrifletti l-gravità tal-marda: "klassi II" tinvolvi limitazzjoni żgħira tal-attività fiżika filwaqt li "klassi III" tinvolvi limitazzjoni evidenti tal-attività fiżika.
English: Overall, 24.4% (140 out of 574) of patients treated with Uptravi either died or showed signs of worsening disease compared with 36.4% (212 out of 582) of patients treated with placebo.
Maltese: B'mod ġenerali, 24.4 % (140 minn 574) tal-pazjenti kkurati b'Uptravi jew mietu jew urew sinjali ta' aggravar tal-marda mqabbla mas-36.4 % (212 minn 582) tal-pazjenti kkurati bil-plaċebo.
English: Uptravi contains the active substance selexipag.
Maltese: Uptravi fih is-sustanza attiva selexipag.
English: Other information about Uptravi
Maltese: Informazzjoni oħra dwar Uptravi
English: The active substance in Uptravi, selexipag, is a ‘prostacyclin receptor agonist'.
Maltese: Is-sustanza attiva f'Uptravi, selexipag, hija "agonista ta-riċettur prostacyclin".
English: Why is Uptravi approved?
Maltese: Għaliex ġiet approvat Uptravi?
English: What are the risks associated with Uptravi?
Maltese: X'inhuma r-riskji assoċjati ma' Uptravi?
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku selexipag
English: Uptravi is a medicine used to treat adults with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Maltese: Uptravi huwa mediċina użata għall-kura ta' adulti bi pressjoni għolja fl-arterji tal-pulmun (PAH, pressjoni tad-demm għolja b'mod anormali fl-arterji tal-pulmun).
English: This is a summary of the European public assessment report (EPAR) for Uptravi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Uptravi.
English: Patients with moderately reduced liver function should start with 200 micrograms once daily.
Maltese: Il-pazjenti li jbatu minn tnaqqis moderat fil-funzjoni tal-fwied għandhom jibdew b'200 mikrogramma darba kuljum.
English: The most common side effects with Uptravi (which may affect more than 1 in 10 people) are headache, diarrhoea, nausea and vomiting, jaw pain, myalgia (muscle pain), pain in the limbs, arthralgia (joint pain) and flushing.
Maltese: L-effetti sekondarji l-aktar komuni b'Uptravi (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma wġigħ ta' ras, dijarea, dardir u rimettar, uġigħ fix-xedaq, mijalġija (uġigħ fil-muskoli), uġigħ fir-riġlejn, antralġja (uġigħ fil-ġogi) u fwawar.
English: Uptravi must not be taken at the same time as medicines, such as gemfibrozil, that are strong blockers (inhibitors) of the liver enzyme CYP2C8.
Maltese: Uptravi ma għandux jittieħed fl-istess ħin ma' mediċini oħra, bħall-gemfibrozil, li huma blokkatori b'saħħithom ħafna (inibituri) tal-enzima tal-fwied CYP2C8.
English: How is Uptravi used?
Maltese: Kif jaħdem Uptravi?
English: The dose is then increased weekly, as long as it is tolerated, to a maximum of 1,600 micrograms twice daily, which is then continued afterwards.
Maltese: Imbagħad, id-doża tiżdied kull ġimgħa, sakemm din tkun tollerata, sa massimu ta' 1,600 mikrogramma darbtejn kuljum, li mbagħad titkompla wara.
English: Treatment should be started at a dose of 200 micrograms twice a day, approximately 12 hours apart.
Maltese: Il-kura għandha tinbeda b'doża ta' 200 mikrogramma darbtejn kuljum, u tittieħed bejn wieħed u ieħor f'intervalli ta' 12-il siegħa.
English: It can be used in combination with other medicines called endothelin receptor antagonists (ERA) or phosphodiesterase type-5 (PDE-5) inhibitors or on its own for patients for whom these medicines are not suitable.
Maltese: Jista' jintuża flimkien ma' mediċini oħrajn li jissejħu antagonisti tar-riċettur tal-endotelina (ERA) jew inibituri tal-phosphodiesterase ta' tip5 (PDE-5) jew waħdu għall-pazjenti li għalihom dawn il-mediċini mhumiex tajbin.
English: Uptravi is used in patients with functional class II or III PAH.
Maltese: Uptravi jintuża f'pazjenti b'PAH tal-klassi funzjonali
English: This means that it works in a similar way to prostacyclin, a naturally occurring substance that regulates blood pressure by attaching to receptors in the muscles of blood vessel walls, causing the vessels to relax and widen.
Maltese: Dan ifisser li taħdem b'mod simili għal prostacyclin, sustanza naturali li tirregola l-pressjoni tad-demm billi teħel marriċetturi fil-muskoli tal-ħajt tal-vażi tad-demm, li twassal biex il-vażi jirrilassaw u jitwessgħu.
English: Although the CHMP noted a small apparent increase in the rate of death for patients taking Uptravi when compared with placebo, they considered that this was due to chance or to the way the study was designed and therefore did not impact the benefits or risks of the medicine.
Maltese: Minkejja li s-CHMP innota żieda apparenti żgħira fir-rata ta' mwiet għal pazjenti li jieħdu Uptravi, meta mqabbla mal-plaċebo, hu qies li din kienet b'kumbinazzjoni jew il-mod ta' kif l-istudju kien imfassal u għalhekk ma għamlitx impatt fuq ilbenefiċċji jew ir-riskji tal-mediċina.
English: Compared with other medicines in the same class which are given into a vein, Uptravi has the advantage of being given by mouth.
Maltese: Meta mqabbel ma' mediċini oħrajn flistess klassi li jingħataw fil-vina, Uptravi għandu l-vantaġġ li jingħata mill-ħalq.
English: Patients with PAH currently have very limited treatment options; therefore there is a high unmet medical need.
Maltese: Pazjenti b'PAH attwalment għandhom għażliet ta' kura limitati ħafna; għalhekk hemm ħtieġa medika għolja mhux sodisfatta.
English: For the full list of restrictions and side effects reported with Uptravi, see the package leaflet.
Maltese: Għal-lista sħiħa tar-restrizzjonijiet u tal-effetti sekondarji kollha rrappurtati b'Uptravi, ara l-fuljett ta' tagħrif.
English: For patients with other heart problems, Uptravi must only be used under close medical supervision.
Maltese: Għal pazjenti bi problemi oħrajn tal-qalb, Uptravi għandu jintuża biss taħt superviżjoni medika stretta.
English: Uptravi has been shown to be more effective than placebo at preventing worsening of PAH, on its own and when used in addition to an ERA and/or a PDE-5 inhibitor.
Maltese: Uptravi wera li huwa iżjed effettiv mill-plaċebo biex jipprevjeni l-PAH milli jiggrava, waħdu jew meta jintuża flimkien ma' ERA u/jew ma' inibitur tal-PDE-5.
English: PAH is a debilitating disease where there is severe narrowing of the blood vessels of the lungs.
Maltese: Il-PAH hija marda debilitanti fejn ikun hemm tidjiq serju tal-vażi tad-demm tal-pulmuni.
English: Uptravi must not be used in patients who have had a heart attack within the last 6 months, severe coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle) or unstable angina (a severe type of chest pain).
Maltese: Uptravi ma għandux jintuża f'pazjenti li kellhom attakk tal-qalb fl-aħħar 6 xhur, marda tal-qalb koronarja severa (marda tal-qalb ikkawżata mill-imblukkar tal-vini tad-demm li jissupplixxu l-muskolu tal-qalb) jew anġina mhux stabbli (tip sever ta' uġigħ fis-sider).
English: The benefits of Uptravi for PAH were shown in one main study involving 1,156 patients with PAH.
Maltese: Il-benefiċċji ta' Uptravi għal PAH intwerew fi studju wieħed ewlieni li kien jinvolvi 1,156 pazjent b'PAH.
English: What measures are being taken to ensure the safe and effective use of Uptravi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Uptravi?
English: What benefits of Uptravi have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Uptravi li ħarġu mill-istudji?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Uptravi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Uptravi huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Note: This SPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Maltese: Nota: Dan l-SPC, it-tikketta u l-fuljett ta' tagħrif, huma fil-verżjoni valida ta' meta ġiet meħudha d-deċiżjoni tal-Kummissjoni.
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Maltese: Wara d-deċiżjoni tal-Kummisjoni, l-awtoritajiet kompetenti ta l-istati Membri, flimkien ma' l-Istat Membru ta' Referenza se jaġġornaw l-informazzjoni tal-prodott kif meħtieġ.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-sommarju tal-karatteristiċi tal-prodott, tikkettar u fuljett ta' tagħrif validi huma l-verżjonijiet finali li ġew milħuqa waqt il-proċedura tal-grupp ta' Ko-ordinazzjoni.