FrancophonIA/ELRC3.0 huggingface dataset:
English: • Prevention of relapse of gastric ulcers
Maltese: • Prevenzjoni tal-ħruġ mill-ġdid ta' ulċeri gastriċi
English: Patients are also instructed to consult a doctor if they have had previous gastric ulcer or gastrointestinal surgery, in case of jaundice, hepatic impairment, or liver disease and if they are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Maltese: Il-pazjenti ngħataw struzzjonijiet ukoll biex jikkonsultaw tabib jekk kellhom ulċera gastrika jew għamlu operazzjoni gastro-intestinali, fil-każ ta' suffejra, indeboliment tal-fwied, jew mard tal-fwied jew jekk ikunu fuq trattament sintomatiku kontinwu tal-indiġestjoni jew il-qrusa fl-istonku għal 4 ġimgħat jew aktar.
English: Reflux oesophagitis results from the combination of excessive gastro-oesophageal reflux of gastric juice and impaired oesophageal clearance of the refluxate.
Maltese: b) “Trattament ta' esofaġite ta' rifluss” u “Ġestjoni fit-tul ta' pazjenti b'esofaġite ta' rifluss imfejqa” L-esofaġite ta' rifluss tirriżulta mill-kombinazzjoni tar-rifluss gastro-esofagali eċċessiv ta' likwidu gastriku u l-indeboliment fit-tneħħija esofagali tar-refluxate.
English: Regarding special populations, dose adjustment is not needed in patients with impaired renal function, as omeprazole is almost completely metabolized by CYP450, renal impairment does therefore not influence the pharmacokinetics.
Maltese: Popolazzjonijiet speċjali: il-formulazzjonijiet kollha Rigward il-popolazzjonijiet speċjali, m'hemmx bżonn ta' aġġustament fid-doża f'pazjenti li jkollhom indeboliment fil-funzjoni renali, billi omeprazole huwa metabolizzat kważi għal kollox minn CYP450, indeboliment tal-kliewi għalhekk ma jaffettwax il-farmakokinetiċi.
English: The CHMP considered that prevention of relapse of H. pylori negative duodenal ulcers is sufficiently demonstrated and considered these indications to be approvable.
Maltese: Is-CHMP ħass li l-prevenzjoni tal-ħruġ mill-ġdid ta' ulċeri duwodenali negattivi H. pylori hija murija b'mod suffiċjenti u qies li dawn l-indikazzjonijiet jistgħu jiġu approvati.
English: The CHMP considered that there is sufficient information on human experience to state that excretion of omeprazole in milk is low and unlikely to influence the child. Data from epidemiological studies on use of Losec during pregnancy indicates no adverse effects and the CHMP considered that omeprazole can be used during pregnancy.
Maltese: Kienet inserita dikjarazzjoni addizzjonali għall-formulazzjonijiet tal-infużjoni u tal-injezzjoni, li ssostni li fuq il-bażi ta' provi kliniċi, id-dożi eċċessivi ma wasslu għall-ebda reazzjoni avversa marbuta mad-doża.
English: For the treatment of duodenal ulcers, the recommended dose is 20 mg once daily.
Maltese: Għat-trattament tal-ulċeri duwodenali, id-doża rakkomandata hija 20 mg darba kuljum.
English: The CHMP concluded that omeprazole is a suitable medication to relief heartburn and acid regurgitation in the OTC setting, provided that the patient complies with the recommended dosing and correct use, as instructed by the SPC and the Patient Leaflet.
Maltese: Is-CHMP ikkonkluda li omeprazole huwa medikazzjoni xierqa sabiex ittaffi l-qrusa fl-istonku u r-rigurġitazzjoni tal-aċidu fis-sitwazzjoni OTC, bil-kundizzjoni li l-pazjent jikkonforma mad-doża u l-użu korrett rakkomandat, kif indikati flSPC u l-Fuljett ta' Tagħrif.
English: Although this food interaction is not likely to be of any clinical relevance, it warrants the recommendation that Losec should preferably be taken without food.
Maltese: Għalkemm din l-interazzjoni mal-ikel mhijiex probabbli lit kun ta' rilevanza klinika, hija jixirqilha r-rakkomandazzjoni li Losec għandu preferibbilment jittieħed mingħajr ikel.
English: f) “In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease”
Maltese: f) “F'kombinazzjoni ma' antibijotiċi xierqa, il-qerda tal-Helicobacter pylori (H. pylori) fil-mard talulċeri peptiċi” Is-CHMP ħass li skont il-gwida eżistenti kważi kollha, il-pazjenti kollha b'erużjonijiet jew ulċeri assoċjati ma' infezzjoni tal-H. pylori għandhom ikunu sottoposti għal terapija sabiex jinqered lorganiżmu.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom jipprevjeni s-sustanza attiva milli tinqered mill-aċidu fl-istonku.
English: The full EPAR and risk management plan summary for Duloxetine Zentiva 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: Duloxetine Zentiva contains the active substance duloxetine and is is a ‘generic medicine'.
Maltese: Duloxetine Zentiva fih is-sustanza attiva duloxetine u huwa ‘mediċina ġenerika'.
English: This means that Duloxetine Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Maltese: Dan ifisser li Duloxetine Zentiva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha Cymbalta.
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Zentiva.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Duloxetine Zentiva.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the feet, legs, hands and arms that can occur in patients with diabetes);
Maltese: • uġigħ minħabba newropatija periferika dijabetika (ħsara lin-nervituri fis-saqajn, riġlejn u idejn li tista' sseħħ f'pazjenti bid-dijabete);
English: Why is Duloxetine Zentiva approved?
Maltese: Għaliex ġie approvat Duloxetine Zentiva?
English: The active substance in this medicine, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Is-sustanza attiva f'din il-mediċina, duloxetine, hija inibitur tal-assorbiment mill-ġdid ta' serotoninanoradrenalina.
English: Duloxetine Zentiva is available as gastroresistant capsules (30 and 60 mg).
Maltese: Duloxetine Zentiva huwa disponibbli bħala kapsuli gastroreżistenti (30 u 60 mg). ‘Gastroreżistenti' tfisser li l-kontenut tal-kapsuli jgħaddi mill-istonku u jibqa' intatt sa meta jilħaq l-intestini.
English: Other information about Duloxetine Zentiva
Maltese: Informazzjoni oħra dwar Duloxetine Zentiva
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Zentiva has been shown to have comparable quality to Cymbalta and to be bioequivalent to Cymbalta.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Duloxetine Zentiva wera li għandu kwalità komparabbli u huwa bijoekwivlenti għal Cymbalta.
English: For major depression, the recommended dose of Duloxetine Zentiva is 60 mg once a day.
Maltese: Għal dipressjoni qawwija, id-doża rakkomandata ta' Duloxetine Zentiva hija 60 mg kuljum.
English: Because Duloxetine Zentiva is a generic medicine of Cymbalta, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Duloxetine Zentiva huwa mediċina ġenerika ta' Cymbalta, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Because Duloxetine Zentiva 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 Duloxetine Zentiva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Therefore, the CHMP's view was that, as for Cymbalta, the benefit outweighs the identified risk.
Maltese: Għaldaqstant il-fehma tas-CHMP kienet li, bħal fil-każ ta' Cymbalta, ilbenefiċċji huma akbar mir-riskju identifikat.
English: A risk management plan has been developed to ensure that Duloxetine Zentiva is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Duloxetine Zentiva jintuża bl-aktar mod sigur possibbli.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku duloxetine
English: The Committee recommended that Duloxetine Zentiva be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Duloxetine Zentiva ikun approvat għall-użu fl-UE.
English: Most patients will need to take 60 mg per day.
Maltese: Il-maġġoranza talpazjenti ser jeħtieġu doża ta' 60 mg kuljum.
English: How is Duloxetine Zentiva used?
Maltese: Kif jintuża Duloxetine Zentiva?
English: What are the benefits and risks of Duloxetine Zentiva?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Duloxetine Zentiva?
English: Duloxetine Zentiva duloxetine
Maltese: Kif ġie studjat Duloxetine Zentiva?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Abbażi ta' dan il-pjan, fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Duloxetine Zentiva, inklużi l-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti tal-kura tas-saħħa u l-pazjenti.
English: For diabetic neuropathic pain, the recommended dose is 60 mg per day but some patients may need a higher dose of up to 120 mg per day.
Maltese: Għal uġigħ newropatiku dijabetiku, id-doża rakkomandata hija 60 mg darba kuljum, iżda xi pazjenti aktarx jeħtieġu doża aktar qawwija ta' 120 mg kuljum.
English: It contains the active substance pegaspargase.
Maltese: Fih is-sustanza attiva pegaspargase.
English: Further information on Oncaspar can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR Oncaspar.
Maltese: ema.europa.eu/medicines/human/EPAR Oncaspar.
English: This compares with 66% of those treated with another asparaginase.
Maltese: Dan jipparaguna ma' 66% ta' dawk ikkurati b'asparaginase ieħor.
English: Oncaspar received a marketing authorisation valid throughout the EU on 14 January 2016.
Maltese: Oncaspar ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-14 ta' Jannar 2016.
English: Other information about Oncaspar
Maltese: Informazzjoni oħra dwar Oncaspar
English: Oncaspar is a cancer medicine used in adults and children to treat acute lymphoblastic leukaemia (ALL), a cancer of white blood cells called lymphoblasts.
Maltese: Oncaspar huwa mediċina kontra l-kanċer li tintuża f'adulti u fi tfal biex tikkura lewkimja akuta limfoblastika (ALL), kanċer fiċ-ċelloli bojod tad-demm li jissejħu limfoblasti.
English: What are the risks associated with Oncaspar?
Maltese: X'inhuma r-riskji assoċjati ma' Oncaspar?
English: Oncaspar is used in combination with other cancer medicines.
Maltese: Oncaspar jintuża f'kombinazzjoni ma' mediċini oħra kontra l-kanċer.
English: The active substance (pegaspargase) contains the enzyme asparaginase which works by breaking up and reducing the blood levels of the amino acid asparagine.
Maltese: Is-sustanza attiva (il-pegaspargase) fiha l-enzima asparaginase li taħdem billi tkisser u tnaqqas il-livelli tad-demm tal-amino aċidu asparagina.
English: In another study of 76 children whose cancer returned after earlier treatment, around 40% of Oncaspar-treated patients (some of whom were allergic to other asparaginase treatments) were cleared of the cancer, compared with 47% of patients treated with an asparaginase comparator.
Maltese: Fi studju ieħor ta' 76 tifel u tifla fejn il-kanċer irritorna wara kura preċedenti, madwar 40% tal-pazjenti kkurati b'Oncaspar (li wħud minnhom kienu allerġiċi għal kuri oħra b'asparaginase) kienu ħielsa millkanċer, meta mqabbla ma' 47% tal-pazjenti kkurati b'komparatur ta' asparaginase.
English: The most common side effects with Oncaspar (which may affect more than 1 in 10 people) include signs of liver problems (raised levels of liver enzymes and bilirubin in the blood), reduced blood clotting, high levels of fats in the blood, high levels of blood glucose and low levels of white blood cells accompanied by fever.
Maltese: L-effetti sekondarji l-iktar komuni b'Oncaspar (li jistgħu jaffettwaw iktar minn persuna 1 minn kull 10) jinkludu sinjali ta' problemi fil-fwied (livelli għolja ta' enzimi tal-fwied u bilirubina fid-demm), inqas emboli tad-demm, livelli għolja ta' xaħam fid-demm, livelli għolja ta glukożju fid-demm u livelli baxxi ta' ċelloli bojod tad-demm akkumpanjati bid-deni.
English: As for all medicines, data on the use of Oncaspar are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Oncaspar hija ssorveljata kontinwament.
English: Oncaspar is normally given every 14 days by injection into a muscle or by infusion (drip) into a vein, with the dose depending on age and body surface area.
Maltese: Oncaspar normalment jingħata kull 14-il jum permezz ta' injezzjoni f'muskolu jew permezz ta' infużjoni (dripp) fil-vina, bid-doża skont l-età u l-erja tas-superfiċje tal-ġisem.
English: Why is Oncaspar authorised in the EU?
Maltese: Għaliex Oncaspar huwa awtorizzat fl-UE?
English: In a study in 118 children newly diagnosed with ALL, 75% of those treated with Oncaspar (in combination with other medicines) were free of the cancer after 7 years, without having relapse or a new cancer during that period.
Maltese: Fi studju f'118-il tifel u tifla li kienu għadhom kif ġew dijanjostikati b'ALL, 75% ta' dawk ikkurati b'Oncaspar (flimkien ma' mediċini oħra) kienu ħielsa mill-kanċer wara 7 snin mingħajr ma rkadew jew kellhom kanċer ġdid matul dak il-perjodu.
English: What measures are being taken to ensure the safe and effective use of Oncaspar?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Oncaspar?
English: Studies showed Oncaspar to be effective in patients with ALL, including patients who were allergic to asparaginase.
Maltese: L-istudji wrew li Oncaspar huwa effettiv f'pazjenti b'ALL, inkluż pazjenti li kienu allerġiċi għallasparaginażi.
English: For the full list of side effects of Oncaspar, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Oncaspar, ara l-fuljett ta' tagħrif.
English: As for its risks, the side effects of Oncaspar are similar to those of other asparaginase medicines and are considered manageable
Maltese: Rigward ir-riskji tiegħu, l-effetti sekondarji ta' Oncaspar huma simili għal dawk ta' mediċini asparaginażi oħra u huma maniġġabbli.
English: Oncaspar must not be used in patients with severe liver disease, patients who have ever had pancreatitis (including pancreatitis caused by previous asparaginase treatments) or patients who have had severe bleeding or serious blood clots following asparaginase treatment.
Maltese: Oncaspar ma għandux jintuża f'pazjenti b'mard serju tal-fwied, pazjenti li xi darba kellhom pankreatite (inkluża l-pankreatite kkawżata minn kuri ta' asparaginażi preċedenti) jew dawk li kellhom fsada severa jew emboli tad-demm serji wara kura b'asparaginażi.
English: Side effects reported with Oncaspar are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Oncaspar huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The asparaginase enzyme in this medicine is linked to a chemical which slows down its removal from the body and can reduce the risk of allergic reactions.
Maltese: L-enzima asparaginase f'din il-mediċina hija marbuta ma' kimika li tnaqqas ir-ritmu tat-tneħħija tagħha mill-ġisem u tista' tnaqqas ir-riskju ta' reazzjonijiet allerġiċi.
English: EMA/337032/2015 EMEA/H/C/000555
Maltese: EMEA/H/C/000555
English: Orfadin nitisinone
Maltese: Orfadin nitisinon
English: It is available as capsules (2 mg, 5 mg, 10 mg and 20 mg) and as a suspension (4 mg/ml) to be taken by mouth.
Maltese: Jiġi bħala kapsuli (2 mg, 5 mg, 10 mg u 20 mg) u bħala sospensjoni (4 mg/ml) li tittieħed mill-ħalq.
English: The full EPAR for Orfadin 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: Thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), granulocytopenia (low levels of granulocytes, a type of white blood cell), conjunctivitis (inflammation of the membrane that lines the eyelid), corneal opacity (clouding of the cornea, the transparent layer in front of the pupil), keratitis (inflammation of the cornea), photophobia (increased sensitivity of the eyes to light) and eye pain are also common (seen in between 1 and 10 patients in 100).
Maltese: Tromboċitopenija (għadd baxx ta' pjastrini fid-demm), lewkopenija (għadd baxx ta' ċelloli bojod tad-demm), granuloċitopenija (livelli baxxi ta' granuloċiti, tip ta' ċellola bajda tad-demm), konġuntivite (infjammazzjoni talmembrana ta' madwar tebqet il-għajn), opaċità korneali (il-kornea, is-saff trasparenti tal-parti ta' quddiem tal-pupilla, ma tibqax ċara), keratite (infjammazzjoni tal-kornea), fotofobija (żieda fissensittività tal-għajnejn għad-dawl) u uġigħ fl-għajnejn huma komuni wkoll (dehru f'bejn pazjent 1 u 10 f'kull 100).
English: Orfadin is a medicine that contains the active substance nitisinone.
Maltese: Orfadin huwa mediċina li fiha s-sustanza attiva nitisinon.
English: Orfadin is used to treat hereditary tyrosinaemia type 1 (HT-1).
Maltese: Orfadin jintuża għall-kura tat-tirosinemija ereditarja tat-tip 1 (HT-1).
English: Other information about Orfadin
Maltese: Informazzjoni oħra dwar Orfadin
English: With additional Orfadin treatment, the survival rate increases to 82%.
Maltese: B'kura addizzjonali ta' Orfadin, ir-rata ta' sopravivenza tiżdied għal 82%.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Orfadin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European public assessment report (EPAR) for Orfadin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Orfadin.
English: Because the number of patients with HT-1 is low, the disease is considered ‘rare', and Orfadin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 December 2000.
Maltese: Minħabba li n-numru ta' pazjenti b'HT-1 huwa wieħed baxx, il-marda hija meqjusa bħala‘ rari', u Orfadin ġie kklassifikat bħala‘ mediċina orfni' (mediċina użata f'mard rari) fid-29 ta' Diċembru 2000.
English: The active substance in Orfadin, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Maltese: Is-sustanza attiva f'Orfadin, in-nitisinon, timblokka enzima li tikkonverti t-tirożina f'sustanzi perikolużi.
English: What is Orfadin?
Maltese: X'inhu Orfadin?
English: The largest study of Orfadin was carried out in 257 patients in 87 different hospitals in 25 countries, as part of a ‘compassionate-use' programme.
Maltese: L-akbar studju ta' Orfadin twettaq f'257 pazjent f'87 sptar differenti f'25 pajjiż, bħala parti minn programm ‘ta' użu b'kumpassjoni'.
English: Orfadin is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Maltese: Orfadin jintuża flimkien ma' dieta li tillimita lkonsum tal-amino aċidi msejħa tirożina u l-fenilalanina.
English: For example, a baby less than two months old with HT-1 would normally have only a 28% chance of surviving for five years using a modified diet alone.
Maltese: Pereżempju, tarbija ta' inqas minn xahrejn b'HT-1 normalment għandha 28% biss ċans li tgħix għal ħames snin bl-użu ta' dieta modifikata weħidha.
English: Orfadin was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of the approval.
Maltese: Orfadin kien oriġinarjament awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni', għaliex, minħabba li l-marda hija rari, kien hemm disponibbli biss informazzjoni limitata fi żmien l-approvazzjoni.
English: Orfadin also provides a better outcome for patients than that reported in the literature in patients eating a modified diet alone.
Maltese: Orfadin jipprovdi wkoll riżultat aħjar għal pazjenti milli dak irrappurtat fid-dokumentazzjoni f'pazjenti li jingħataw dieta modifikata weħidha.
English: The recommended starting dose is 1 mg per kilogram body weight per day, divided into two doses.
Maltese: Id-doża inizjali rrakkomandata hija 1 mg kull kilogramm ta' piż tal-ġisem, maqsuma f'żewġ dożi.
English: As the company had submitted the additional information requested, the ‘exceptional circumstances' ended on 21 September 2009.
Maltese: Peress li lkumpanija kienet issottomettiet l-informazzjoni addizzjonali mitluba, iċ-“ċirkostanzi ta' eċċezzjoni" ntemmu fil-21 ta' Settembru 2009.
English: Why has Orfadin been approved?
Maltese: Għaliex ġie approvat Orfadin?
English: A risk management plan has been developed to ensure that Orfadin is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Orfadin jintuża bl-aktar mod sigur possibbli.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Orfadin on 21 February 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Orfadin valida fl-Unjoni Ewropea kollha fil-21 ta' Frar 2005.
English: How has Orfadin been studied?
Maltese: Kif ġie studjat Orfadin?
English: The CHMP noted that Orfadin seems to be an effective treatment for HT-1, particularly if it is started early, before the patient's liver is too damaged.
Maltese: Is-CHMP innota li Orfadin jidher li huwa kura effikaċi għal HT-1, b'mod partikolari jekk jinbeda kmieni, qabel ma tkun saret wisq ħsara lill-fwied tal-pazjent.
English: What measures are being taken to ensure the safe and effective use of Orfadin?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Orfadin?
English: For the full list of all side effects and restrictions with Orfadin, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Orfadin, ara l-fuljett ta' tagħrif.
English: What is the risk associated with Orfadin?
Maltese: X'inhu r-riskju assoċjat ma' Orfadin?
English: Therefore, the CHMP decided that Orfadin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għaldaqstant, is-CHMP iddeċieda li l-benefiċċji ta' Orfadin huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fuq is-suq.
English: Date of last renewal: 26/07/2018.
Maltese: Data tal-aħħar tiġdid: 26/07/2018.
English: 1BANNEX II
Maltese: 1BANNESS II
English: 20 tablets 50 tablets 100 tablets
Maltese: 20 pillola 50 pillola 100 pillola
English: ATC vet code: QD11AH90.
Maltese: QD11AH90.
English: Cellulose, microcrystalline Lactose monohydrate Magnesium stearate Sodium starch glycolate
Maltese: Cellulose, mikrokristallin Lactose monohydrate Magnesium stearate Sodium starch glycolate
English: Date of first authorisation: 12/09/2013.
Maltese: Data tal-ewwel awtorizazzjoni: 12/09/2013.
English: Anaemia and lymphoma have been reported very rarely in spontaneous reports.
Maltese: Anemija u limfoma kienu raportati rari ħafna f'rapporti spontanji.
English: Via del Commercio 25/27 63100 Marino Del Tronto (AP) ITALY
Maltese: 63100 Marino Del Tronto (AP) L-ITALJA
English: Following intravenous and oral administration, the terminal t1/2s were similar at 3.5 and 4.1 hours respectively.
Maltese: Wara amministrazzjoni fil-vina jew mill-ħalq, it-terminal t1/2s kienu simili ta' 3.5 u 4.1 hours rispettivament.
English: Oclacitinib is a Janus kinase (JAK) inhibitor.
Maltese: Oclacitinib huwa inibitur Janus kinase (JAK).
English: The absolute bioavailability of oclacitinib maleate was 89%.
Maltese: Il-bijodisponibilità assoluta ta' oclacitinib maleate kienet ta' 89%.
English: Polydipsia
Maltese: Polidipsja