FrancophonIA/ELRC3.0 huggingface dataset:
English: Prevenar 13 suspension for injection in multidose container Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Maltese: Prevenar 13 suspensjoni għall-injezzjoni f'kontenitur b'ħafna dożi Tilqima ta' konjugat (13-valenti, adsorbit) ta' polysaccharide Pnewmokokkali
English: EMA/477399/2014 EMEA/H/C/000088
Maltese: EMEA/H/C/000088
English: The full EPAR for Humalog 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: Humalog insulin lispro
Maltese: Humalog insulina lispro
English: • Humalog Basal: insulin lispro protamine suspension;
Maltese: • Humalog Basal: sospensjoni ta' insulina lispro protamina;
English: • Humalog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);
Maltese: • Humalog: soluzzjoni ta' insulina lispro, disponibbli b'qawwa standard jew ogħla (100 jew 200 unità/ml);
English: This is a summary of the European public assessment report (EPAR) for Humalog.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Humalog.
English: The active substance in Humalog, insulin lispro, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce insulin lispro.
Maltese: Is-sustanza attiva f'Humalog, l-insulina lispro tiġi prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': jiġi magħmul minn batterji li fihom ikun ġie introdott ġene (DNA) li jagħmilhom kapaċi jipproduċu l-insulina lispro.
English: Humalog Mix, Humalog Basal and Humalog 200 units/ml should never be given into a vein.
Maltese: Humalog Mix, Humalog Basal u Humalog 200 unità/ml ma għandhom qatt jingħataw fil-vina.
English: Humalog Mix is a mixture of these two formulations.
Maltese: Humalog Mix hija taħlita ta' dawn iż-żewġ formulazzjonijiet.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Humalog on 30 April 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Humalog valida fl-Unjoni Ewropea kollha fit-30 ta' April 1996.
English: Humalog was originally studied in eight clinical trials including 2951 patients with type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively).
Maltese: Humalog ġie studjat oriġinarjament fi tmien provi kliniċi li kienu jinkludu 2951 pazjent li għandhom jew id-dijabete tat-tip1 (fejn il-ġisem ma jistax jipproduċi insulina) jew id-dijabete tat-tip 2 (meta l-ġisem ma jkunx kapaċi juża l-insulina b'mod effikaċi).
English: The Humalog range comprises fast-acting insulin solutions (Humalog), longer-acting insulin suspensions (Humalog Basal), and combinations of both in various proportions (Humalog Mix):
Maltese: Il-varjetà Humalog fiha soluzzjonijiet ta' insulina li taġixxi fil-pront (Humalog), sospensjonijiet ta' insulina li taġixxi aktar fit-tul (Humalog Basal), u kombinazzjonijiet tat-tnejn f'porzjonijiet varji (Humalog Mix):
English: Humalog 100 units/ml may also be given by continuous infusion using an insulin pump or into a vein.
Maltese: Humalog 100 unità/ml jista' jingħata wkoll permezz ta' infużjoni kontinwa bl-użu ta' pompa tal-insulina jew fil-vina.
English: What is Humalog?
Maltese: X'inhu Humalog?
English: Studies also looked at the use of Humalog in 542 patients aged between two and 19 years, and the use of Humalog in combination with sulphonylureas.
Maltese: L-istudji eżaminaw ukoll l-użu ta' Humalog f'542 pazjent bejn sentejn u 19-il sena, u l-użu tiegħu flimkien ma' sulfonilureji.
English: Why has Humalog been approved?
Maltese: Għaliex ġie approvat Humalog?
English: Humalog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Maltese: Humalog u Humulin R kellhom effett simili fuq il-kontroll tad-dijabete kif imkejla mill-HbA1c u l-livelli tal-glukożju fi stat ta' sawm.
English: Humalog, Humalog Basal and Humalog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy).
Maltese: Humalog, Humalog Basal u Humalog Mix jistgħu jingħataw b'injezzjoni taħt il-ġilda tal-parti ta' fuq taddriegħ, koxxa, warrani jew fil-parti addominali (iż-żaqq).
English: Humalog is a replacement insulin which is very similar to the insulin made by the body.
Maltese: Humalog huwa insulina ta' sostituzzjoni li hija simili ħafna għall-insulina li jipproduċi l-ġisem.
English: Insulin lispro is available as Humalog in the soluble form, which acts more or less immediately after injection, and as Humalog Basal in the ‘protamine suspension' form, which is absorbed much more slowly so that it works for longer.
Maltese: L-insulina lispro hija disponibbli bħala Humalog f'forma ta' solubbli, li taġixxi pjuttost immedjatament wara l-injezzjoni, u bħala Humalog Basal f'forma ta' ‘sospensjoni protamina', li hija assorbita aktar bilmod sabiex taħdem aktar fit-tul.
English: Humalog is a range of solutions and suspensions for injection that contain the active substance insulin lispro and are supplied in vials, cartridges and prefilled pens (Humalog KwikPen).
Maltese: Humalog hija varjetà ta' soluzzjonijiet u sospensjonijiet għal injezzjoni li fihom is-sustanza attiva insulin lispro u jiġu fi fjali, stoċċijiet u pinen mimlija minn qabel (Humalog KwikPen).
English: Humalog can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).
Maltese: Humalog jista' jintuża flimkien ma' insulina li taġixxi aktar fit-tul jew flimkien ma' sulfonilureji (grupp ta' mediċini antidijabetiċi li jittieħdu oralment).
English: The Committee for Medicinal products for Human Use (CHMP) decided that Humalog's benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Humalog huma akbar mir-riskji tiegħu għall-kura ta' pazjenti bid-dijabete mellitus li jeħtieġu l-insulina għażżamma ta' omeostażi tal-glukożju normali, u għall-istabbilizzazzjoni inizjali tad-dijabete mellitus.
English: How has Humalog been studied?
Maltese: Kif ġie studjat Humalog?
English: A risk management plan has been developed to ensure that Humalog is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Humalog jintuża bl-aktar mod sigur possibbli.
English: What measures are being taken to ensure the safe and effective use of Humalog?
Maltese: X'miżuri qegħdin jittieħdu biex jassiguraw użu sigur u effettiv ta' Humalog?
English: The effectiveness of Humalog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when added to long-acting insulins given once or twice a day.
Maltese: L-effikaċja ta' Humalog tqabblet ma' dik ta' Humulin R (rikombinant tad-DNA solubbli tal-insulina umana), meta ġew miżjuda ma' insulini li jaġixxu aktar fittul u mogħtija darba jew darbtejn kuljum.
English: Humalog 200 units/ml must only be injected under the skin, using the KwikPen device in which it is supplied.
Maltese: Humalog 200 unità/ml għandu jiġi injettat biss taħt il-ġilda, bl-użu tat-tagħmir KwikPen li fih jiġi fornit.
English: Verkazia ciclosporin
Maltese: Verkazia ċiklosporina
English: Verkazia contains the active substance ciclosporin.
Maltese: Verkazia fih is-sustanza attiva ċiklosporina.
English: The full EPAR for Verkazia 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 summary of the opinion of the Committee for Orphan Medicinal Products for Verkazia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Verkazia jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In a main study involving 169 children and adolescents with severe VKC, 55% of patients treated with Verkazia achieved CFS improvements of 50% or more, without the need of other medications, after 4 months, compared with around 28% of patients receiving a dummy treatment.
Maltese: Fi studju ewlieni li fih ħadu sehem 169 tifel u tifla u adoloxxenti b'VKC serja, 55 % tal-pazjenti kkurati b'Verkazia kisbu titjib f'CFS ta' 50 % jew aktar, mingħajr il-ħtieġa ta' mediċini oħra, wara 4 xhur, meta mqabbla ma' madwar 28 % tal-pazjenti li rċivew kura finta.
English: Why is Verkazia approved?
Maltese: Għal xiex ġie approvat Verkazia?
English: This is a summary of the European public assessment report (EPAR) for Verkazia.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta᾽ valutazzjoni (EPAR) għal Verkazia.
English: Other information about Verkazia
Maltese: Informazzjoni oħra dwar Verkazia
English: The active substance in Verkazia, ciclosporin, blocks cells of the immune system (the body's natural defences) that are involved in the processes that cause the allergic reaction and inflammation in patients with VKC.
Maltese: Is-sustanza attiva f'Verkazia, iċ-ċiklosporina, timblokka liċ-ċelloli tas-sistema immunitarja (id-difiżi naturali tal-ġisem) li huma involuti fil-proċessi li jikkawżaw ir-reazzjoni allerġika u infjammazzjoni filpazjenti b'VKC.
English: What are the risks associated with Verkazia?
Maltese: X'inhuma r-riskji assoċjati ma' Verkazia?
English: Because the number of patients with vernal keratoconjunctivitis is low, the disease is considered ‘rare', and Verkazia was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 April 2006.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn keratoconjunctivitis huwa baxx, il-marda hija kkunsidrata “rari”, u Verkazia ġie kklassifikat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fis6 ta' April 2006.
English: How does Verkazia work?
Maltese: Kif jintuża Verkazia?
English: Verkazia reduces damage to the cornea (layer in the front of the eye) in most patients with VKC as shown by improvements in ‘corneal fluorescence staining' (CFS) scores (a standard measure of corneal health).
Maltese: Verkazia jnaqqas il-ħsara fil-kornea (saff fin-naħa ta' quddiem tal-għajn) f'ħafna mill-pazjenti b'VKC kif muri mit-titjib fil-punteġġi ta' “tbajja tal-fluworexxenza korneali” (corneal fluorescence staining - CFS) (kejl standard tas-saħħa tal-kornea).
English: Some of the patients were treated for an additional 8 months; this extension study showed that the benefits of Verkazia were maintained with continued use for up to 12 months.
Maltese: Uħud mill-pazjenti ġew ikkurati għal 8 xhur oħra; dan l-istudju ta' estensjoni wera li lbenefiċċji ta' Verkazia nżammu b'użu kontinwu ta' mhux aktar minn 12-il xahar.
English: For the full list of all side effects and restrictions with Verkazia, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati b'Verkazia, ara l-fuljett ta' tagħrif.
English: Verkazia is a medicine used to treat severe vernal keratoconjunctivitis (VKC), an allergic condition that affects the eye and mostly occurs seasonally, although in some patients symptoms can recur or persist all year round.
Maltese: Verkazia huwa mediċina li tintuża biex tikkura keratoconjunctivitis vernali (VKC) serja, li hija kundizzjoni allerġika li taffettwa l-għajn u li sseħħ l-aktar staġjonalment, għalkemm f'xi pazjenti ssintomi jistgħu jerġgħu jitfaċċaw jew jippersistu matul is-sena kollha.
English: The recommended dose is 1 drop 4 times a day in each affected eye, during VKC season.
Maltese: Dan jintuża fit-tfal u fladoloxxenti minn 4 snin sa 18-il sena.
English: The full EPAR for Tacforius 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: Starting doses are between 0.1 and 0.3 mg per kg bodyweight daily.
Maltese: Iddożi tal-bidu huma bejn 0.1 u 0.3 mg għal kull kg tal-piż tal-ġisem kuljum.
English: This is a summary of the European public assessment report (EPAR) for Tacforius.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tacforius.
English: Other information about Tacforius
Maltese: Informazzjoni oħra dwar Tacforius
English: Tacforius contains the active substance tacrolimus and is a ‘generic medicine'.
Maltese: Tacforius fih is-sustanza attiva tacrolimus u huwa ‘mediċina ġenerika'.
English: Tacrolimus, the active substance in Tacforius, is an immunosuppressive medicine.
Maltese: Tacrolimus, is-sustanza attiva f'Tacforius, huwa mediċina immunosoppressiva.
English: Tacrolimus reduces the activity of cells in the immune system, called T-cells, that are primarily involved in attacking the transplanted organ (organ rejection).
Maltese: Tacrolimus inaqqas lattività ta' ċerti ċelloli fis-sistema immuni, imsejħa ċelloli-T, li huma primarjament involuti fl-attakk fuq l-organu trapjantat (rifjut tal-organu).
English: Why is Tacforius approved?
Maltese: Għaliex ġie approvat Tacforius?
English: Because Tacforius is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Tacforius huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Advagraf, and do not need to be repeated for Tacforius.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċina ta' referenza, Advagraf, u m'għandhomx għalfejn jiġu ripetuti għal Tacforius.
English: What are the benefits and risks of Tacforius?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Tacforius?
English: How has Tacforius been studied?
Maltese: Kif ġie studjat Tacforius?
English: Tacforius tacrolimus
Maltese: Kif jintuża Tacforius?
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku tacrolimus
English: Tacforius can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Maltese: Tacforius jista' jintuża wkoll biex jikkura rifjut ta' organu f'pazjenti adulti meta mediċini immunosoppressivi oħrajn (mediċini li jnaqqsu l-attività tas-sistema immuni) ma jkunux effettivi.
English: The Agency recommended that Tacforius be approved for use in the EU.
Maltese: L-Aġenzija rrakkomandat li Tacforius ikun approvat għall-użu fl-UE.
English: Tacforius is used for the long-term treatment of adult patients who have had a kidney or liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Maltese: Tacforius jintuża għall-kura fit-tul ta' pazjenti adulti li kellhom trapjant tal-kliewi jew tal-fwied, biex jipprevjeni rifjut (meta s-sistema immuni tattakka l-organu trapjantat).
English: This means that Tacforius contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Advagraf.
Maltese: Dan ifisser li Tacforius fih listess sustanza attiva u jaħdem bl-istess mod tal-'mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Advagraf.
English: The prolonged-release capsules allow tacrolimus to be released slowly from the capsule over several hours so that it needs to be taken only once a day.
Maltese: Il-kapsuli ta' rilaxx imdewwem jippermettu lil tacrolimus biex jiġi rilaxxat bil-mod mill-kapsula fuq perjodu ta' diversi sigħat sabiex ikun jeħtieġ li jittieħed biss darba kuljum.
English: Tacforius is available as prolonged-release capsules containing tacrolimus.
Maltese: Tacforius jiġi bħala kapsuli ta' rilaxx imdewwem li fihom tacrolimus.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Tacforius has been shown to have comparable quality and to be bioequivalent to Advagraf.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Tacforius wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Advagraf.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija għamlet ukoll studji li wrew li huwa ‘bijoekwivalenti' għall-mediċina ta' referenza.
English: EMA/248293/2019 EMEA/H/C/004954
Maltese: EMA/248293/2019 EMA/H/C/004954
English: Further information on Ultomiris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Ultomiris.
Maltese: ema.europa.eu/medicines/human/EPAR/Ultomiris.
English: Other information about Ultomiris
Maltese: Informazzjoni oħra dwar Ultomiris
English: As for its safety, Ultomiris has similar side effects to eculizumab.
Maltese: Fir-rigward tas-sigurtà tiegħu, Ultomiris għandu effetti sekondarji simili għal eculizumab.
English: Ultomiris is a medicine used to treat adults with paroxysmal nocturnal haemoglobinuria (PNH).
Maltese: Ultomiris huwa mediċina li tintuża biex tikkura adulti b'emoglobinurija notturna paroksismali (PNH).
English: The active substance contained in Ultomiris, ravulizumab, is a monoclonal antibody (a type of protein) designed to attach to the C5 protein, which is part of the complement system.
Maltese: Is-sustanza attiva li tinsab f'Ultomiris, ir-ravuliżumab, hija antikorp monoklonali (tip ta' proteina) iddisinjata biex teħel mal-proteina C5, li hija parti mis-sistema ta' komplement.
English: After 6 months of treatment, similar benefits were seen in both groups, with two-thirds or more of patients (74% given Ultomiris and 66% given eculizumab) not needing red blood cell transfusions.
Maltese: Wara 6 xhur ta' kura, benefiċċji simili dehru fiż-żewġ gruppi, b'żewġ terzi jew aktar ta' pazjenti (74 % mogħtija Ultomiris u 66 % mogħtija eculizumab) ma jkollhomx bżonn trasfużjonijiet ta' ċelloli ħomor tad-demm.
English: What are the risks associated with Ultomiris?
Maltese: X'inhuma r-riskji assoċjati ma' Ultomiris?
English: In the second study in 195 patients with PNH who did not have symptoms after at least 6 months of treatment with eculizumab, patients either continued treatment with eculizumab or switched to Ultomiris.
Maltese: Fit-tieni studju f'195 pazjent b'PNH li ma kellhomx sintomi wara mill-inqas 6 xhur ta' kura b'eculizumab, il-pazjenti jew komplew il-kura b'eculizumab jew qalbu għal Ultomiris.
English: In the first study, 246 patients with PNH who previously had not been treated with a medicine blocking the complement system, such as eculizumab, received either Ultomiris or eculizumab.
Maltese: Fl-ewwel studju, 246 pazjent bil-PNH li qabel ma kinux ġew ikkurati b'mediċina li timblokka s-sistema ta' komplement, bħal eculizumab, irċevew jew Ultomiris jew eculizumab.
English: The change in blood levels of LDH after 6 months of treatment was similar in the 2 groups.
Maltese: It-tibdil fil-livelli ta' LDH fid-demm wara 6 xhur ta' kura kien simili fiż-2 gruppi.
English: As for all medicines, data on the use of Ultomiris are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ultomiris hija ssorveljata kontinwament.
English: The most common side effects with Ultomiris (which may affect more than 1 in 10 people) are upper respiratory tract infection (nose and throat infection), nasopharyngitis (inflammation of the nose and throat) and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Ultomiris (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjoni fil-parti ta' fuq tal-apparat respiratorju (infezzjoni tal-imnieħer u tal-griżmejn), nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn) u wġigħ ta' ras.
English: How is Ultomiris used?
Maltese: Ultomiris?
English: By attaching to the C5 protein, the medicine blocks its effect and thereby reduces the destruction of red blood cells.
Maltese: Billi teħel mal-proteina C5, il-mediċina timblokka l-effett tagħha u b'hekk tnaqqas il-qerda taċ-ċelloli ħomor tad-demm.
English: Ultomiris contains the active substance ravulizumab.
Maltese: Ultomiris fih is-sustanza attiva ravuliżumab.
English: Ultomiris is given as an infusion (drip) into a vein and the recommended dose depends on the patient's bodyweight.
Maltese: Ultomiris jingħata bħala infużjoni (dripp) fil-vina u d-doża rakkomandata tiddependi mill-piż tal-ġisem tal-pazjent.
English: The company that markets Ultomiris will ensure that the medicine is only made available to patients when healthcare professionals have made a written declaration that they have been vaccinated or are receiving antibiotic treatment to prevent meningococcal disease.
Maltese: Il-kumpanija li tqiegħed lil Ulitoris fis-suq se tiżgura li l-mediċina ssir disponibbli biss għall-pazjenti meta l-professjonisti fil-qasam tal-kura tas-saħħa jkunu għamlu dikjarazzjoni bil-miktub li tlaqqmu jew qed jirċievu kura antibijotika biex jiġi evitat il-mard meningokokkali.
English: PNH is a potentially life-threatening disease in which there is excessive breakdown of red blood cells, leading to problems such as anaemia (low red blood cell counts), kidney problems and blood clots in the blood vessels.
Maltese: PNH hija marda li tista' tkun ta' theddida għall-ħajja fejn ikun hemm tkissir eċċessiv taċ-ċelloli ħomor tad-demm, li jwassal għal problemi bħall-anemija (għadd baxx ta' ċelloli ħomor tad-demm), problemi fil-kliewi u emboli tad-demm fil-vażi tad-demm.
English: How does Ultomiris work?
Maltese: Kif jaħdem Ultomiris?
English: The Agency therefore decided that Ultomiris' benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-Aġenzija ddeċidiet li l-benefiċċji ta' Ultomiris huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: In PNH, proteins known as the 'complement system', which is part of the immune system, become overactive because of a genetic mutation and start to attack the patients' own red blood cells.
Maltese: Fil-PNH, proteini magħrufa bħala s-“sistema ta' komplement”, li hija parti mis-sistema immunitarja, isiru attivi żżejjed minħabba mutazzjoni ġenetika u jibdew jattakkaw iċ-ċelloli ħomor tad-demm talpazjenti stess.
English: Ultomiris was shown in 2 studies to be as effective as eculizumab in reducing the breakdown of red blood cells and avoiding the need for transfusions in patients with PNH.
Maltese: Ultomiris intwera f'2 studji li kien effettiv daqs l-eculizumab fit-tnaqqis tat-tkissir taċ-ċelloli ħomor taddemm u fl-evitar tal-ħtieġa ta' trasfużjonijiet f'pazjenti bil-PNH.
English: No data are available.
Maltese: M'hemm l­ebda data disponibbli.
English: McDermott Laboratories Limited trading as Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 Ireland
Maltese: McDermott Laboratories Limited li jagħmlu l-kummerċ bħala Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 L-Irlanda
English: Hypocalcaemia (see sections 4.2 and 4.4).
Maltese: Ipokalċimija (ara sezzjonijiet 4.2 u 4.4).
English: * see section c) see section 4.4
Maltese: * ara sezzjoni c) ara sezzjoni 4.4
English: System organ class
Maltese: Klassi ta' sistemi tal organi
English: The mean reductions in serum Ca x P, calcium, and phosphorus were 14%, 7% and 8%, respectively.
Maltese: It-tnaqqis medju ta' Ca x P, kalċju, u fosforu fis-serum kien ta' 14%, 7% u 8%, rispettivament.
English: Testosterone levels
Maltese: Livelli ta' testosterone
English: Italia Mylan Italia S.r.l.
Maltese: Mylan Italia S.r.l.
English: For additional information see section 4.
Maltese: Għal aktar informazzjoni ara sezzjoni 4.