FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that makes Esbriet has set up a post-authorisation safety study in order to collect additional information on patients prescribed Esbriet and suspected side effects.
Maltese: Il-kumpanija li tipproduċi Esbriet ħejjiet studju ta' sigurtà ta' wara l-awtorizzazzjoni biex tiġbor informazzjoni addizzjonali dwar il-pazjenti li ngħataw Esbriet u l-effetti sekondarji suspettati.
English: Esbriet was more effective than placebo (a dummy treatment) at slowing down the worsening of lung function in two main studies involving a total of 779 IPF patients.
Maltese: Esbriet kien iktar effettiv mill-plaċebo (kura finta) fit-tnaqqis tal-progressjoni tat-taħżin tal-funzjoni talpulmun f'żewġ studji ewlenin li kienu jinvolvu total ta' 779 pazjent b'IPF.
English: What are the risks associated with Esbriet?
Maltese: X'inhuma r-riskji assoċjati ma' Esbriet?
English: The mechanism of action of pirfenidone, the active substance in Esbriet, is not fully understood but it has been shown to reduce the production of fibroblasts and other substances involved in the formation of fibrous tissue during the body's tissue repair process, thereby slowing down the progression of the disease in IPF patients.
Maltese: Il-mekkaniżmu ta' azzjoni tal-pirfenidon, is-sustanza attiva f'Esbriet, mhuwiex mifhum għal kollox, iżda ntwera li jnaqqas il-produzzjoni ta' fibroblasti u sustanzi oħrajn li jikkontribwixxu għall-formazzjoni ta' tessut fibruż matul il-proċess tat-tiswija tat-tessut tal-ġisem, b'hekk titnaqqas il-progressjoni tal-marda f'pazjenti b'IPF.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that Esbriet has been shown to slow down the progression of IPF, as measured by FVC, without serious risks for patients.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija qies li Esbriet intwera li jnaqqas il-progressjoni ta' IPF, kif imkejla bl-FVC, mingħajr riskji serji għall-pazjenti.
English: Patients who have side effects such as stomach problems, skin reactions to light or significant changes in the levels of liver enzymes may need to take a lower dose at least temporarily.
Maltese: Pazjenti li jkollhom effetti sekondarji bħal problemi fl-istonku, reazzjonijiet tal-ġilda minn bidla ħafifa sa sinifikanti fil-livelli tal-enzimi tal-fwied jista' jkollhom bżonn li d-doża tagħhom titnaqqas għallinqas temporanjament.
English: IPF is a long-term disease in which fibrous scar tissue continuously forms in the lungs, causing persistent cough, frequent lung infections and severe shortness of breath.
Maltese: IPF hija marda fit-tul li fiha jifforma kontinwament tessut fibruż b'ċikatriċi fil-pulmuni, fejn jikkawża sogħla persistenti, infezzjonijiet frekwenti fil-pulmun u qtugħ ta' nifs sever. ‘Idjopatika' tfisser li l-kawża tal-marda mhijiex magħrufa.
English: How is Esbriet used?
Maltese: Kif jaħdem Esbriet?
English: administration
Maltese: Amministrazzjoni
English: Packaging Content
Maltese: Ippakkjar Kontenut Daqs talPakket
English: Trelegy Ellipta (fluticasone furoate / umeclidinium bromide / vilanterol)
Maltese: Trelegy Ellipta (fluticasone furoate / bromur talumeklidinju / vilanterol)
English: Further information on Trelegy Ellipta can be found on the Agency's website: ema.europa.eu/ medicines/Human/EPAR/Trelegy-Ellipta.
Maltese: ema.europa.eu/ medicines/Human/EPAR/Trelegy-Ellipta.
English: Fluticasone furoate is a corticosteroid.
Maltese: Fluticasone furoate hija kortikosterojde.
English: Vilanterol is a long-acting beta-2 agonist.
Maltese: Il-vilanterol hija agonista beta-2 li taġixxi fit-tul.
English: Trelegy Ellipta received a marketing authorisation valid throughout the EU on 15 November 2017.
Maltese: Trelegy Ellipta rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-15 ta' Novembru 2017.
English: It contains the active substances fluticasone furoate, umeclidinium bromide and vilanterol.
Maltese: Fih is-sustanzi attivi fluticasone furoate, bromur tal-umeklidinju u vilanterol.
English: Other information about Trelegy Ellipta
Maltese: Informazzjoni oħra dwar Trelegy Ellipta
English: Trelegy Ellipta is a medicine used to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Maltese: Trelegy Ellipta huwa mediċina użata biex ittaffi s-sintomi tal-mard pulmonari ostruttiv kroniku (COPD, chronic obstructive pulmonary disease) minn moderat sa sever.
English: Umeclidinium bromide is a muscarinic receptor antagonist.
Maltese: Il-bromur tal-umeklidinju hija antagonista tar-riċettur muskariniku.
English: In this study, Trelegy Ellipta reduced the rate of moderate and severe exacerbations over one year by 15% compared with treatment with vilanterol and fluticasone furoate, and by 25% compared with treatment with vilanterol and umeclidinium bromide.
Maltese: F'dan l-istudju, Trelegy Ellipta naqqas ir-rata ta' aggravar minn moderat u sever fuq sena b'15 % meta mqabbel mal-kura b'vilanterol u fluticasone furoate, u b'25 % meta mqabbel mal-kura b'vilanterol u lbromur tal-umeklidinju.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom proċess ta' infjammazzjoni, bħall-istamina, b'hekk tnaqqas l-infjammazzjoni u tgħin biex iżżomm ilpassaġġi tal-arja miftuħin u tippermetti li l-pazjent jieħu n-nifs b'mod aktar faċli.
English: Another study involving 1,810 patients whose COPD was not satisfactorily controlled with a daily maintenance treatment for their COPD found Trelegy Ellipta more effective at improving patients' breathing than an inhaled combination of budesonide, a corticosteroid, and formoterol, a long-acting beta-2 agonist.
Maltese: Studju ieħor li involva 1,810 pazjenti u li s-COPD tagħhom ma kinitx ikkontrollata b'mod sodisfaċenti bil-kura ta' manutenzjoni ta' kuljum għas-COPD tagħhom, sab li Trelegy Ellipta huwa aktar effettiv biex itejjeb it-teħid tan-nifs tal-pazjenti milli kieku tittieħed man-nifs taħlita ta' budesonide, kortikosterojde u formoterol li huwa agonista beta-2 li jaġixxi fit-tul
English: A study compared Trelegy Ellipta with either vilanterol given with fluticasone furoate or vilanterol with umeclidinium bromide, in 10,355 patients with advanced COPD who were at risk of exacerbations and whose disease was not satisfactorily controlled with a daily maintenance treatment.
Maltese: Studju qabbel Trelegy Ellipta jew ma' vilanterol mogħtija ma' fluticasone furoate jew vilanterol malbromur tal-umeklidinju, f'10,355 pazjent b'COPD avvanzata li kienu f'riskju ta' aggravar u li l-marda tagħhom ma kinitx ikkontrollata b'mod sodisfaċenti b'kura ta' manutenzjoni ta' kuljum.
English: Long-acting beta-2 agonists widen the airways; corticosteroids reduce inflammation in the airways and lungs; and muscarinic receptor antagonists cause the muscles of the airways to relax.
Maltese: L-agonisti beta-2 li jaġixxu fit-tul iwessgħu l-passaġġi tal-arja; il-kortikosterojdi jnaqqsu l-infjammazzjoni fil-passaġġi tal-arja u l-pulmun; u lantagonisti tar-riċettur muskariniku jikkawżaw ir-rilassament tal-muskoli tal-passaġġi tal-arja.
English: It works by blocking muscarinic receptors, which are involved in the contraction of muscles.
Maltese: Din taħdem billi timblokka rriċetturi muskariniċi, li huma involuti fil-kontrazzjoni tal-muskoli.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors (targets) in various types of immune cells.
Maltese: Din taħdem b'mod simili għal ormoni kortikosterojdi li jseħħu b'mod naturali, billi tnaqqas l-attività tas-sistema immunitarja billi teħel ma' riċetturi (objettivi) f'diversi tipi ta' ċelloli immunitarji.
English: Regarding the safety profile of the medicine, the most frequent side effects reported with Trelegy Ellipta were similar to those with the individual active substances of the medicine and are well known.
Maltese: Fir-rigward tal-profil tas-sigurtà tal-mediċina, l-effetti sekondarji l-aktar frekwenti li ġew irrapportati bi Trelegy Ellipta kienu simili għal dawk tas-sustanzi attivi individwali tal-mediċina u huma magħrufin tajjeb.
English: How is Trelegy Ellipta used?
Maltese: Kif jintuża Trelegy Ellipta?
English: The most common side effects with Trelegy Ellipta (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), headache and upper respiratory tract infection (nose and throat infection).
Maltese: L-effetti sekondarji l-aktar komuni bi Trelegy Ellipta (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn), ugigħ ta' ras u infezzjoni talapparat respiratorju ta' fuq (infezzjoni tal-imnieħer u tal-griżmejn).
English: Trelegy Ellipta is used for maintenance (regular) treatment on a daily basis.
Maltese: Trelegy Ellipta jintuża bħala kura ta' manutenzjoni (regolari) kuljum.
English: This compares with an average reduction of 29 ml seen in patients taking the combination of budesonide and formoterol over the same period.
Maltese: Dan jitqabbel ma' medja ta' tnaqqis ta' 29 ml f'pazjenti li jieħdu taħlita ta' budesonide u formoterol fl-istess perjodu.
English: What are the risks associated with Trelegy Ellipta?
Maltese: Kif jaħdem Trelegy Ellipta?
English: Trelegy Ellipta is used in adults whose disease is not controlled well enough with a combination of inhaled medicines consisting of a long-acting beta-2 agonist plus either a corticosteroid or a longacting muscarinic antagonist.
Maltese: Trelegy Ellipta jintuża f'adulti li l-marda tagħhom mhijiex ikkontrollata tajjeb biżżejjed b'taħlita ta' mediċini li jittieħdu man-nifs li tikkonsisti minn agonist beta-2 li jaġixxi fit-tul flimkien ma' jew kortikosterojde jew antagonist muskariniku li jaġixxi fit-tul.
English: After 24 weeks, patients taking Trelegy Ellipta had their FEV1 (the maximum volume of air they could breathe out in one second) improve by 142 ml.
Maltese: Wara 24 ġimgħa, il-pazjenti li ħadu Trelegy Ellipta tejbu l-FEV1 (il-volum massimu ta' arja li tista' titfa' 'l barra minn imnifsejk f'sekonda waħda) tagħhom b'142 ml.
English: Trelegy Ellipta can only be obtained with a prescription.
Maltese: Aktar informazzjoni dwar Trelegy Ellipta tinstab fis-sit elettroniku tal-Aġenzija:
English: Trelegy Ellipta improves lung function as well as the quality of life of patients with moderate to severe COPD.
Maltese: Trelegy Ellipta jtejjeb il-funzjoni tal-pulmun kif ukoll il-kwalità tal-ħajja tal-pazjenti b'COPD minn moderata sa severa.
English: As for all medicines, data on the use of Trelegy Ellipta are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Trelegy Ellipta hija ssorveljata kontinwament.
English: <Or>
Maltese: <Jew>
English: <[Invented name] contains lactose.
Maltese: <[Isem ivvintat] fih lactose.
English: The initial dose is one tablet (1-1.65 mg) per day at mealtime.
Maltese: Id-doża inizjali hija ta' pillola waħda (1-1.65 mg) kuljum fil-ħin tal-ikel.
English: Retro-peritoneal fibrosis (see General disorders).
Maltese: Fibrożi retro-peritoneali (ara Disturbi ġenerali).
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbji respiratorji, toraċiċi u medjastinali
English: Skin reactions (e.g. rash, urticaria)
Maltese: Reazzjonijiet fil-ġilda (eż. raxx, urtikarja)
English: Skin reactions (e.g. rash, urticaria).
Maltese: Reazzjonijiet fil-ġilda (eż. raxx, urtikarja).
English: Section 4.8 Undesirable effects [This section should be amended to reflect the following wording]
Maltese: Sezzjoni 4.8 Effetti mhux mixtieqa [Din is-sezzjoni għandha tiġi emendata biex tirrifletti l-formulazzjoni li ġejja]
English: Valvular fibrosis (see General disorders).
Maltese: Fibrożi valvulari (ara Disturbi ġenerali).
English: [Invented name] is to be used only following unsuccessful treatment with other standard classes of drugs (see section 4.4) after sufficient treatment duration (at least 4 months) at the maximal tolerated dose.
Maltese: [Isem ivvintat] għandu jintuża biss wara kura mingħajr suċċess bi klassijiet ta' mediċina standard oħrajn (ara sezzjoni 4.4) wara perjodu ta' kura suffiċjenti (tal-anqas 4 xhur) bid-doża massima ttollerata.
English: (see section 4.4 regarding the need for specialist monitoring requirements)
Maltese: (ara sezzjoni 4.4 fir-rigward tal-ħtieġa ta' rekwiżiti ta' monitoraġġ speċjalizzati)
English: Migraine prophylaxis
Maltese: Profilassi tal-emigranja
English: Cardiac and vascular disorders
Maltese: Disturbi fil-qalb u vaskulari
English: • Prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults.
Maltese: • Kura profilattika ta' emigranja intrattabbli severa (bi jew mingħajr awra) b'diżabilità funzjonali fl-adulti.
English: Patients should be examined regularly for the presence of: peripheral oedema, leg discolouration, digital clubbing, weak/irregular pulse(s), tachycardia, cardiac murmur, vascular bruits, raised jugular vein pressure, lung basal crepitations, pleural/pericardial friction rubs, abdominal/flank masses/tenderness.
Maltese: Il-pazjenti għadhom jiġu eżaminati b'mod regolari għall-preżenza ta': edema periferali, tidnis tarriġlejn, klabbjar diġitali, polz(ijiet) irregolari u dgħajfa, takikardija, ħsejjes tal-qalb, ħsejjes tad-demm vaskulari, pressjoni għolja fil-vina ġugulari, tifqigħ bażali fil-pulmun, ħakk ta' frizzjoni plewrali/perikardjali, mases/tenerezza fl-addome/ġnub.
English: Insomnia, drowsiness, dizziness, minor psychological changes of a temporary nature (nervousness, restlessness, depression and confusion in rare cases).
Maltese: Nuqqas ta' rqad, ngħas, sturdament, bidliet psikoloġiċi żgħar ta' natura temporanja (nervi, irrekwitezza, depressjoni u f'każijiet rari konfużjoni).
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rapportar nazzjonali mniżżla f'Appendiċi V*.
English: The following investigations should be performed prior to initiation of treatment with methysergide and at 6-monthly intervals thereafter: cardiac ultrasound, pulmonary function tests, abdominal MRI.
Maltese: L-investigazzjonijiet li ġejjin għandhom jitwettqu qabel ma tinbeda l-kura b'methysergide u f'intervalli ta' 6 xhur minn hemm 'il quddiem: ultrasound tal-qalb, testijiet tal-funzjoni pulmonari, MRI addominali.
English: [Invented name] belong to a group of medicines called antimigraine drugs.
Maltese: [Isem ivvintat] jagħmel parti minn grupp ta' mediċini li jissejħu mediċini kontra l-emigranja.
English: Pleuro-pulmonary fibrosis (see General disorders), dyspnoea, pleurisy, pleural effusion.
Maltese: Fibrożi plewro-pulmonari (ara Disturbi ġenerali), qtugħ ta' nifs, plewriżi, effużjoni plewrali.
English: The maximum dose should not exceed 6 mg per day.
Maltese: Id-doża massima ma għandhiex taqbeż is-6 mg kuljum.
English: - For prophylactic treatment of severe intractable migraine a number of other classes of treatment may be considered (e.g. beta-blockers, anticonvulsivants, calcium channel blocker or tricyclic antidepressants).
Maltese: klassijiet oħrajn ta' kura (eż. imblokkaturi beta, kura kontra l-konvulżjonijiet, imblokkatur tal kanal tal-kalċju jew antidepressanti triċikliċi).
English: Retroperitoneal fibrosis may cause obstruction of the urinary tract with symptoms such as general asthenia, back pain, lumbar pain, dysuria, oliguria, raised blood nitrogen, nausea, anorexia, and vascular insufficiency, weak pulse and skin discolouration in the lower limbs.
Maltese: Fibrożi retroperitonali tista' tikkawża l-imblokkar tal-passaġġ urinarju b'sintomi bħal astenja ġenerali, uġigħ fid-dahar, uġigħ lumbari, diżurja, oligurja, livell ta' nitroġenu fid-demm għoli, dardir, anoressija, u insuffiċjenza vaskulari, polz dgħajjef u tibdil fil-kulur tal-ġilda fir-riġlejn.
English: If [Invented name] is taken uninterruptedly for a long time, fibrosis (accumulation of scarring in the body organs) was seen at the pleural site (membrane covering the lungs), the peritoneum (membrane covering the abdominal cavity as well as the abdominal organs) and the heart valves.
Maltese: Jekk [Isem ivvintat] jittieħed mingħajr interruzzjoni għal żmien twil, ġiet osservata fibrożi (akkumulazzjoni ta' ċikatriċi fl-organi tal-ġisem) fis-sit tal-plewra (membrana li tkopri l-pulmuni), ilperitonju (membrana li tkopri l-kavità addominali kif ukoll l-organi addominali) u l-valvi tal-qalb.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: It-tagħrif dwar il-prodott jista' jiġi aġġornat sussegwentement mill-awtoritajiet kompetenti tal-Istat Membri, b'kollaborazzjoni mal-Istat Membru ta' Referenza, kif ikun xieraq, skont il-proċeduri stabbiliti fil-Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: [The wording of this section should be read as below]
Maltese: [Il-formolazzjoni ta' din is-sezzjoni għandha taqra kif ġej]
English: Pleuro-pulmonary fibrosis presents as precordial pains, dyspnoea, pleural frictional noise, lung basal crepitations or pleural effusion, digital clubbing, dry cough, anorexia and weight loss.
Maltese: Fibrożi plewro-pulmonari (ara Disturbi ġenerali), diffikultà biex tieħu n-nifs, infjammazzjoni tal-plewra, il-preżenza ta' fluwidu fil-plewra.
English: For episodic cluster headaches, the duration of treatment will be adjusted according to the usual duration of the episodes but normally no longer than 2-3 months.
Maltese: Għal uġigħ ta' ras episodiku f'naħa waħda tar-ras, it-tul tal-kura ser jiġi aġġustat skont it-tul normali tal-episodji, iżda normalment dan ma jkunx itwal minn xahrejn sa 3 xhur.
English: For chronic cluster headache, the therapeutic dose would normally be 6 mg but a higher dose may sometimes be required.
Maltese: Għal uġigħ ta' ras kroniku f'naħa waħda tar-ras, id-doża terapewtika normalment tkun 6 mg, iżda xi drabi tista' tkun meħtieġa doża ogħla.
English: • Prophylactic treatment of episodic and chronic cluster headache in adults.
Maltese: • Kura profilattika ta' uġigħ ta' ras episodiku u kroniku f'naħa waħda tar-ras (cluster headache)
English: Depending on the location of the affected blood vessel, this complication may be expressed as precordial (angina) or abdominal pain, as cold, dull, and painful sensations in the extremities, with or without paresthesia, as reduced or absence of a pulse, and theoretically, through arterial hypertension.
Maltese: Skont il-post tal-arterja taddemm affettwata, din il-kumplikazzjoni tista' tiġi espressa bħala prekordjali (anġina) jew uġigħ addominali, bħala sensazzjoni skomda, ta' kesħa, u ta' uġigħ fl-estremitajiet, bi jew mingħajr parestesija, bħala tnaqqis fil-polz jew nuqqas tiegħu, u teoretikament, permezz ta' pressjoni għolja arterjali.
English: Depending on the location of the affected blood vessel, this complication may be expressed as chest pain or abdominal pain, as cold, dull, and painful sensations in the extremities, with or without numbness, as reduced or absence of a pulse, and theoretically, through arterial tension increase.
Maltese: bħala sensazzjoni skomda, ta' kesħa, u ta' uġigħ fl-estremitajiet, bi jew mingħajr tnemnim, bħala tnaqqis fil-polz jew nuqqas tiegħu, u teoretikament, permezz ta' żieda fit-tensjoni arterjari.
English: This may be observed as heart or vascular murmurs, tachycardia, peripheral oedema, raised JVP or palpitations.
Maltese: Dan jista' jiġi osservat bħala ħsejjes vaskulari jew fil-qalb, takikardja, edema periferali, JVP għolja jew palpitazzjonijiet.
English: How to take [Invented name] [This section should be amended to reflect the following wording] You should only get your medication initiated and supervised by a doctor who specialises in the treatment of migraine and cluster headache (neurologist).
Maltese: Kif gћandek tieћu [Isem ivvintat] [Din is-sezzjoni għandha tiġi emendata biex tirrifletti l-formulazzjoni li ġejja] Il-mediċina tiegħek għandha tinbeda u tiġi sorveljata biss minn tabib li jispeċjalizza fil-kura talemigranja u l-uġigħ tar-ras f'naħa waħda tar-ras (newrologu).
English: Patients should have failed at least 2 classes of drugs before starting methysergide (see section 4.4).
Maltese: Il-pazjenti, jeħtieġ li ma tkunx irnexxitilhom il-kura b'tal-anqas żewġ klassijiet ta' mediċini qabel ma jibdew jieħdu methysergide (ara sezzjoni 4.4).
English: <Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take [Invented name].>
Maltese: <Il-pazjenti bi problemi ereditarji rari ta' intollerenza għal galactose, id-defiċjenza Lapp lactase jew ilmalassorbiment ta' glucose-galactose ma għandhomx jieħdu [Isem ivvintat].>
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.> <Or> <[Invented name] contains lactose and sucrose.
Maltese: Il-pazjenti bi problemi ereditarji rari ta' intollerenza għal galactose, iddefiċjenza Lapp lactase jew il-malassorbiment ta' glucose-galactose ma għandhomx jieħdu din ilmediċina.> <Jew>
English: During clinical assessment of the patient, particular attention should be paid to complaints of: abdominal, loin or chest pain, palpitations, dyspnoea, dry cough, nausea, malaise, fatigue, anorexia/weight loss, urinary symptoms, pain/coldness/numbness in limbs.
Maltese: Matul il-valutazzjoni klinika tal-pazjent, għandha tingħata attenzjoni partikolari lejn l-ilmenti ta': uġigħ addominali, fil-ġenbejn jew fis-sider, palpitazzjonijiet, qtugħ ta' nifs, sogħla vojta, dardir, telqa, għeja, anoressija/telf ta' piż, sintomi ta' mogħdija tal-awrina, uġigħ/kesħa/tmewwit fir-riġlejn.
English: Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.>
Maltese: Il-pazjenti bi problemi eriditarji rari ta' intolleranza għal galactose jew fructose, id-defiċjenza Lapp lactase, jew il-malassorbiment ta' glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase ma għandhomx jieħdu din il-mediċina.>
English: The duration of continuous administration must not exceed six months because of the risk of fibrosis (see section 4.8).
Maltese: It-tul tal-għoti kontinwu, ma għandux jaqbeż is-sitt xhur minħabba r-riskju ta' fibrożi (ara sezzjoni 4.8).
English: Insomnia, somnolence, dizziness, minor mood changes (nervousness, restlessness, depression and confusion in rare cases).
Maltese: Nuqqas ta' rqad, ngħas, sturdament, bidliet żgħar fil-burdata (nervi, irrekwitezza, depressjoni u f'każijiet rari konfużjoni).
English: If symptoms suggestive of a fibrosis occur, treatment with methysergide should be discontinued unless an alternative aetiology is confirmed.
Maltese: Jekk ikun hemm sintomi li jissuġġerixxu fibrożi, il-kura b'methysergide ma għandhiex titkompla sakemm tiġi kkonfermata etjoloġija alternattiva.
English: Cluster headache
Maltese: Disturbi fil-ġilda
English: Retroperitoneal Fibrosis may occur.
Maltese: Jista' jkun hemm Fibrożi Retroperitonali.
English: Fibrotic reactions have been reported, especially of the pleura and retro-peritoneum, and also of the pericardium and cardiac valves.
Maltese: Ġew irrapportati reazzjonijiet fibrotiċi, speċjalment tal-plewra u r-retro-peritonju, u anki tal-perikardju u l-valvi tal-qalb.
English: 6 August 2014
Maltese: 06 ta' Awissu 2014
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Maltese: Riżultat ta' proċedura skont Artiklu 30 tad-Direttiva 2001/83/KE
English: Seroquel is available as tablets (25, 100, 150, 200 and 300 mg) while Seroquel XR is available as prolonged-release tablets (50, 150, 200, 300 and 400 mg).
Maltese: Seroquel jiġi bħala pilloli (25, 100, 150, 200 u 300 mg) filwaqt li Seroquel XR jiġi bħala pilloli għarrilaxx fit-tul (50, 150, 200, 300 u 400 mg).
English: EMA/301727/2014 Rev. 1 EMEA/H/A-30/1362
Maltese: 1 EMEA/H/A-30/1362
English: • treatment of schizophrenia;
Maltese: • kura ta' skiżofrenja;