FrancophonIA/ELRC3.0 huggingface dataset:
English: In general, safety reviews indicate that about 40% of such reports are in patients over 60 years of age.
Maltese: B'mod ġenerali, reviżonijiet ta' sigurtà jindikaw li madwar 40% ta' tali rapporti huma f'pazjenti ta' ‘il fuq minn 60 sena.
English: This comprised non-clinical and clinical data, both published and unpublished, including a thorough QT study, cumulative review of case reports of cardiac disorders and vascular investigations from the safety databases for domperidone products, pharmacoepidemiological studies, and published and unpublished efficacy studies.
Maltese: Dan ikkonsista minn dejta klinika u mhux klinika, kemm ippubblikata kif ukoll le, inkluż studju intensiv tal-QT, reviżjoni kumulativa ta' rapporti ta' każijiet ta' disturbi kardijaċi u investigazzjonijiet vaskulari minn databases ta' sigurtà għal prodotti b'domperidone, studji farmakoepidemjoloġiċi, u studji ta' effikaċja ppubblikati u mhux ippubblikati.
English: • A significant number of cases have been reported with concomitant or co-suspect medication known to prolong QT interval, CYP3A4 inhibitors, or potassium-wasting diuretics.
Maltese: • Ġie rrappurtat numru sinifikanti ta' każi b'mediċina konkomittanti jew ko-suspettata magħrufa li ttawwal l-intervall tal-QT, inibituri CYP3A4, jew dijuretiċi li jaħlu l-potassju.
English: • A review of the safety database of the originator product involving 342 serious reports of cardiac events or vascular investigations highlighted the high frequency of associated cardiovascular risk factors, cardiovascular history, and concomitant medications associated with cardiac arrhythmias in the patients concerned.
Maltese: • Reviżjoni tad-database ta' sigurtà tal-prodott oriġinatur li involviet 342 rapport serju ta' avvenimenti kardijaċi jew investigazzjonijiet vaskulari, enfasizzat il-frekwenza għolja ta' fatturi ta' riskju kardjovaskulari assoċjati, storja kardjovaskulari, u mediċini konkomittanti assoċjati ma' arritmiji kardjaċi fil-pazjenti kkonċernati.
English: Products supplying a dose of 20 mg by mouth, and suppositories of 10 or 60 mg are no longer recommended for use and should be withdrawn, as should combination products with cinnarizine (an antihistamine) where available.
Maltese: Prodotti li jipprovdu doża ta' 20 mg mill-ħalq, u suppożitorji ta' 10 jew 60 mg m'għadhomx jiġu rakkomandati għall-użu u għandhom jiġu rtirati, kif għandhom ukoll ikunu prodotti ta' kombinazzjoni b'cinnarizine (antiistamina) fejn disponibbli.
English: • Domperidone is a medicine that has been used for various stomach and digestive problems.
Maltese: • Domperidone huwa mediċna li ntużat għal diversi problemi diġestivi u tal-istonku.
English: • A review of the evidence confirms a small increased risk of serious cardiac adverse drug reactions related to the use of domperidone, including QTc prolongation, torsade de pointes, serious ventricular arrhythmia and sudden cardiac death.
Maltese: • Reviżjoni tal-evidenza ikkonfermat riskju żgħir miżjud ta' reazzjonijiet avversi ta' mediċini b'effetti kardijaċi serji relatati mal-użu ta' domperidone, inklużi prolongazzjoni tal-QTc, torsade de pointes, arritmija ventrikulari serja u mewt kardijaka f'daqqa.
English: Of 57 reported cardiovascular fatalities, 27 had other risk factors, while 13 had either an implausible relationship to domperidone administration or an alternative aetiology.
Maltese: Mis-57 fatalità kardjovaskulari rrappurtati, 27 kellhom fatturi ta' riskju oħrajn, filwaqt li 13 kellhom jew relazzjoni implawżibbli mal-amministrazzjoni ta'
English: They are available as tablets, oral suspension and suppositories under various trade names (such as Motilium).
Maltese: Huma disponibbli bħala pilloli, sospensjoni orali u suppożitorji b'diversi ismijiet kummerċjali (bħal Motilium).
English: Restrictions on the use of domperidone-containing medicines
Maltese: Restrizzjonijiet dwar l-użu ta' mediċini li fihom domperidone
English: Serious effects on the heart with domperidone, including prolongation of the QT interval (an alteration of the electrical activity of the heart) and arrhythmias (unstable heartbeats), have previously been evaluated by the EMA and the product information updated with relevant warnings.
Maltese: Effetti serji fuq il-qalb b'domperidone, inkluż titwil tal-intervall QT (bidla fl-attività elettrika tal-qalb) u arritmiji (taħbit tal-qalb mhux stabbli), ġew evalwati qabel mill-EMA u linformazzjoni tal-prodott ġiet aġġornata bit-twissijiet rilevanti.
English: The CMDh confirmed by majority the PRAC recommendation that domperidone-containing medicines should remain available and may continue to be used in the EU for the management of the symptoms of nausea and vomiting, but that the recommended dose should be reduced to 10 mg up to three times daily by mouth for adults and adolescents weighing 35 kg or more.
Maltese: Is-CMDh ikkonferma b'maġġoranza r-rakkomandazzjoni tal-PRAC li mediċini li fihom domperidone għandhom jibqgħu jkunu disponibbli u jistgħu jibqgħu jintużaw fl-UE għall-ġestjoni ta' sintomi ta' nawżja u rimettar, iżda li d-doża rakkomandata għandha titnaqqas għal 10 mg sa tliet darbiet kuljum mill-ħalq għall-adulti u adolexxenti li jiżnu 35 kg jew iktar.
English: A higher risk was observed in patients older than 60 years, adults taking daily oral doses of more than 30 mg, and those taking QT-prolonging medicines or CYP3A4 inhibitors concomitantly.
Maltese: Riskju ogħla ġie osservat f'pazjenti ikbar minn 60 sena, adulti li jieħdu dożi orali ta' kuljum ta' aktar minn 30 mg, u dawk li qegħdin jieħdu mediċini li ttawwlu l-QT jew inibituri CYP3A4 b'mod konkomittanti.
English: • Data in support of other indications were extremely limited.
Maltese: • Dejta li tappoġġja indikazzjonijiet oħrajn kienet limitata.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għall-Għarfien Reċiproku u Proċeduri Deċentralizzati - Uman (CMDh), li adotta pożizzjoni finali.
English: • Domperidone products are contraindicated in patients with severe hepatic impairment, conditions where cardiac conduction is, or could be, impaired or where there is underlying cardiac disease such as congestive heart failure, and when co-administered with QT-prolonging medicines or potent CYP3A4 inhibitors.
Maltese: • Prodotti b'domperidone huma kontraindikati f'pazjenti b'indeboliment epatiku sever, kundizzjonijiet fejn il-konduzzjoni kardijaka hija, jew tista' tkun, indebolita jew fejn hemm mard kardijaku sottostanti bħal insuffiċjenza tal-qalb konġestiva , u meta jiġu amministrati flimkien ma' mediċini li jtawwlu l-QT jew inibituri CYP3A4 b'saħħithom.
English: Products licensed in children and adolescents weighing less than 35 kg should be given by mouth at a dose of 0.25 mg per kg bodyweight up to three times daily.
Maltese: Prodotti liċenzjati fi tfal u adolexxenti li jiżnu inqas minn 35 kg għandhom jingħataw mill-ħalq f'doża ta' 0.25 mg għal kull kg ta' piż tal-ġisem sa tliet darbiet kuljum.
English: • The recommended dose in adults is 10 mg by mouth up to three times a day, or 30 mg as a suppository twice a day.
Maltese: • Id-doża rakkomandata fl-adulti hija 10 mg mill-ħalq sa tliet darbiet kuljum, jew 30 mg bħala suppożitorji darbtejn kuljum.
English: In particular, there was little evidence in support of the long-term efficacy of domperidone in dyspepsia and gastro-oesophageal reflux disorder.
Maltese: B'mod partikolari, kien hemm evidenza limitata li tappoġġja l-effikaċja fit-tul ta' domperidone f'dispepsja u disturb ta' rifluss gastroesofagali.
English: There were limited data to support paediatric use in this indication, and although the mechanism of action is not expected to differ between adults and children studies to provide further data to support efficacy in the paediatric population have been requested.
Maltese: Kien hemm dejta limitata biex tappoġja użu pedjatriku f'din l-indikazzjoni, u għalkemm il-mekkaniżmu ta' azzjoni mhuwiex mistenni li jkun differenti bejn adulti u tfal, intalab li jsiru aktar studji li jipprovdu aktar dejta biex tappoġġja l-effikaċja fil-popolazzjoni pedjatrika.
English: The recommendations were originally made by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 3-6 March, after a careful evaluation of the available evidence on the benefits and risks of such medicines.
Maltese: Ir-rakkomandazzjonijiet oriġinarjament saru mill-Kumitat għall-Valutazzjoni tar-Riskju ta' Farmakoviġilanza (PRAC) tal-EMA fil-laqgħa tiegħu tat-3-6 ta' Marzu, wara evalwazzjoni bir-reqqa talevidenza disponibbli dwar il-benefiċċiji u riskji ta' dawn il-mediċni.
English: Adults may also be given 30 mg twice daily rectally as suppositories.
Maltese: L-adulti jistgħu wkoll jingħataw 30 mg darbtejn kuljum mir-rektum bħala suppożitorji.
English: • Where suitable domperidone products are available for children, the recommended dose is 0.25 mg/kg bodyweight up to three times daily by mouth.
Maltese: • Fejn prodotti xierqa b'domperidone huma disponibbli għat-tfal, id-doża rakkomandata hija 0.25 mg/kg ta' piż tal-ġisem sa tliet darbiet kuljum mill-ħalq.
English: • The benefit-risk balance of domperidone remains positive in the relief of the symptoms of nausea and vomiting.
Maltese: • Il-bilanċ benefiċċju-riskju ta' domperidone jibqa' wieħed pożittiv fis-solliev tas-sintomi ta' nawżja u rimettar.
English: • Overall there was sufficient evidence to support the use of oral domperidone 10 mg up to three times a day in a general indication of treatment of nausea and vomiting in adults.
Maltese: • B'mod ġenerali kien hemm evidenza suffiċjenti biex tappoġġja l-użu ta' 10 mg ta' domperidone orali sa tliet darbiet kuljum f'indikazzjoni ġenerali ta' kura ta' nawżja u rimettar fl-adulti.
English: • Although the results of the thorough QT study with domperidone indicate that it does not significantly prolong the QTc interval when administered to healthy subjects at 10 mg and 20 mg four times daily, there are limitations in the study that restrict the conclusions that can be drawn.
Maltese: • Għalkemm ir-riżultati tal-istudju intensiv tal-QT b'domperidone jindikaw li ma jtawwalx l-intervall tal-QTc b'mod sinifikanti meta amministrat lil individwi b'saħħtom f'10 mg u 20 mg erba' darbiet kuljum, hemm limitazzjonijiet fl-istudju li jillimitaw il-konklużjonijiet li jistgħu jinħarġu.
English: There have been concerns that it might increase the risk of side effects on the heart, including dangerously irregular heartbeats in some patients.
Maltese: Kien hemm tħassib li tista' żżid ir-riskju ta' effetti sekondarji fuq il-qalb, inkluż taħbit irregolari b'mod perikoluż f'xi pazjenti.
English: This is in line with the data coming from drug-drug interaction studies, and from spontaneous reporting.
Maltese: Dan huwa f'konformità mad-dejta li ġejja minn studji ta' interazzjoni bejn il-mediċini, u minn rappurtar spontanju.
English: Domperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and vomiting of various causes but also for the management of symptoms such as bloating, discomfort and heartburn.
Maltese: Mediċini li fihom domperidone ġew awtorizzati fuq livell nazzjonali fi Stati Membri tal-UE individwali għall-kura ta' dardir u rimettar ta' diversi kawżi iżda wkoll għall-ġestjoni ta' sintomi bħal nefħa, skumdità u ħruq ta' stonku.
English: Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector
Maltese: Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9,
English: 11317 Tallinn, Estonia
Maltese: 11317 Tallinn,
English: 2970 Hørsholm Denmark
Maltese: 2970 Hørsholm
English: Kampenringweg 45 D-E 2803 PE Gouda The Netherlands
Maltese: Kampenringweg 45 D-E 2803 PE Gouda L-Olanda
English: Estonia sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2
Maltese: L-Estonja sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2
English: Klexane (med konserveringsmedel)
Maltese: Klexane (med konserveringsmede l)
English: Sanofi Romania SRL,
Maltese: Ir-Rumanija Sanofi Romania SRL,
English: Viale L. Bodio 37/b 20158 Milan, Italy
Maltese: Viale L. Bodio 37/b 20158
English: Aventis Pharma Limited One Onslow Street Guildford
Maltese: Pharma Limited One Onslow Street
English: Sanofi AB Box 30052
Maltese: L-Isvezja Sanofi AB Box 30052
English: 1831 Diegem, Belgium
Maltese: 1831 Diegem, Il-Belġju
English: Heinzelova 70, 10000 Zagreb, Croatia
Maltese: Heinzelova 70, 10000
English: Industriepark Höchst Gebäude K703
Maltese: Gebäude K703
English: Denmark sanofi-aventis Denmark A/S Slotsmarken 13
Maltese: Id-Danimarka sanofi-aventis Denmark A/S Slotsmarken 13
English: Latvia sanofi - aventis Latvia SIA
Maltese: Il-Latvja sanofi - aventis Latvia SIA
English: BUDAPEST TÓ U. 1-5 Hungary
Maltese: BUDAPEST TÓ U.
English: Netherlands sanofi-aventis Netherlands B.V.
Maltese: L-Olanda sanofi-aventis Netherlands B.V.
English: Austria sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria
Maltese: L-Awstrija sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, LAwstrija
English: Floor, Avantech Building, St.Julian's Road, San Gwann SGN 2805, Malta
Maltese: Sanofi Malta Ltd 3rd Floor, Avantech Building, St.Julian's Road, San Gwann SGN 2805, Malta
English: Einsteinova 24, 85101 Bratislava Slovak Republic
Maltese: 85101 Bratislava
English: Belgium Sanofi Belgium Leonardo Da Vincilaan 19
Maltese: Il-Belġju Sanofi Belgium Leonardo Da Vincilaan 19
English: Sanofi-Aventis Deutschland GmbH
Maltese: Il-Ġermanja Sanofi-Aventis Deutschland GmbH
English: Sanofi-aventis France 82 avenue Raspail 94250 Gentilly FRANCE
Maltese: Sanofi-aventis Franza 82 avenue Raspail 94250
English: 120 mg (12000 IU)
Maltese: 120 mg (12000
English: 10 single doses of 40 mg)
Maltese: 10 dożi ta' darba ta' 40 mg)
English: Bucureşti, Romania
Maltese: Sector 2, Bucureşti, Ir-Rumanija
English: Slovak Republic sanofi-aventis Slovakia s.r.o.
Maltese: Is-Slovakja sanofi-aventis Slovakia s.r.o.
English: Spain sanofi-aventis, S.A. C/ Josep Pla, 2 08019 Barcelona Spain
Maltese: Spanja sanofi-aventis, S.A. C/ Josep Pla, 2
English: 80 mg (8000 IU)
Maltese: 80 mg (8000
English: Letališka 29 A 1000 Ljubljana Slovenia
Maltese: 1000 Ljubljana
English: Croatia sanofi-aventis Croatia d.o.o.
Maltese: Il-Kroazja sanofi-aventis Croatia d.o.o.
English: 40 mg (4000 IU)
Maltese: 40 mg (4000
English: Clexane 6000 anti-Xa
Maltese: Clexane 6000
English: 10 000 anti-Xa IU /1.0 ml (100 mg/1 ml)
Maltese: 10 000 antiXa IU /1.0 ml (100 mg/1 ml)
English: Sanofi-aventis Ireland Ltd T/A SANOFI
Maltese: Sanofi-aventis Ireland Ltd T/A SANOFI Citywest Business Campus Dublin 24
English: Greece sanofi-aventis AEBE 348, Syngrou Av. - Building A, 176 74 Kallithea - Athens Greece
Maltese: Il-Greċja sanofi-aventis AEBE 348, Syngrou Av.
English: 30 000 anti-Xa IU /3.0 ml (300 mg/3 ml)
Maltese: 30 000 antiXa IU /3.0 ml (300 mg/3 ml)
English: Czech Republic sanofi-aventis, s.r.o.
Maltese: Ċeka sanofi-aventis, s.r.o.
English: Clexane 40 mg
Maltese: Clexane 40 mg 40 mg
English: 20 mg (2000 IU)
Maltese: 20 mg (2000
English: Clexane 20 mg Praxis 20 mg
Maltese: Clexane 20 mg Praxis
English: Clexane 20mg
Maltese: Clexane 20mg 20 mg
English: Aventis Pharma Limited One Onslow Street Guildford, Surrey GU1 4YS United Kingdom
Maltese: Guildford, Surrey GU1 4YS Ir-Renju Unit
English: Clexane 150 mg/ml
Maltese: Clexane 150 mg/ml 150 mg/ml
English: Clexane 300 mg/3 ml 300 mg/ 3ml
Maltese: Clexane 300 mg/3 ml
English: Clexane 40 mg Praxis 40 mg
Maltese: Clexane 40 mg Praxis
English: Sanofi Oy Huopalahdentie 24 00350 Helsinki Finland
Maltese: Il-Finlandja Sanofi Oy Huopalahdentie 24
English: 104 25 Stockholm Sweden
Maltese: 08019 Barcelona Spanja
English: Sanofi-Aventis France 82, Avenue Raspail 94250 Gentilly France
Maltese: Il-Polonja Sanofi-Aventis Franza 82, Avenue Raspail
English: Clexane 10 000 antiXa TV/1,0 ml injekcinis tirpalas užpildytame švirkšte
Maltese: Clexane 10 000 anti-Xa TV/1,0 ml injekcinis tirpalas užpildytame švirkšte
English: Clexane 2000 anti-Xa
Maltese: Clexane 2000
English: Clexane 100 mg/ml
Maltese: Clexane 100 mg/ml 100 mg/ml
English: SANOFI-AVENTIS Zrt.
Maltese: L-Ungerija SANOFI-AVENTIS Zrt. 1045.
English: LOVENOX 30 000 UI Anti-Xa/3 ml, solution injectable en flacon multidose
Maltese: Anti-Xa/3 ml, solution injectable en flacon multidose
English: 60 mg/ 0.6 ml Solution for injection Subcutaneous use
Maltese: 60 mg/0.6 ml Soluzzjoni għall
English: United-Kingdom
Maltese: Ir-Renju Unit
English: 80 mg/ 0.8 ml Solution for injection Subcutaneous use
Maltese: 80 mg/0.8 ml Soluzzjoni għall
English: 20 mg/ 0.2 ml Solution for injection Subcutaneous use
Maltese: 20 mg/0.2 ml Soluzzjoni għall
English: 150 mg/1 ml
Maltese: 150 mg/1 ml Soluzzjoni għall
English: United Kingdom
Maltese: Ir-Repubblika
English: 40 mg/ 0.4 ml Solution for injection Subcutaneous use
Maltese: 40 mg/0.4 ml Soluzzjoni għall
English: Slovenia sanofi-aventis d.o.o.
Maltese: Is-Slovenja sanofi-aventis d.o.o. Letališka 29 A
English: Finland
Maltese: Stockholm
English: 100 mg/1 ml
Maltese: 100 mg /1 ml Soluzzjoni għall
English: 100 mg / 1,0 ml
Maltese: 10 000 antiXa IU/1.0 ml
English: Clexane 120 mg (12.000 UI) solución inyectable en jeringa precargada
Maltese: Clexane 120 mg (12.000
English: Hungary
Maltese: Litwanja
English: Clexane 2000 IU anti-Xa/0,2 ml otopina za injekciju u napunjenoj štrcaljki
Maltese: Clexane 2000 antiXa SV/0,2 ml šķīdums injekcijām pilnšļircē
English: 300 mg/3 ml
Maltese: 300 mg/3 ml Soluzzjoni għall
English: Lovenox 100 mg/ml Durchstichflasche
Maltese: Lovenox 100 mg/ml
English: LOVENOX 2000 UI anti-Xa/0,2 ml, solution injectable en seringue préremplie
Maltese: UI anti-Xa/0,2 ml, solution injectable en seringue préremplie
English: Itraconazole is an antifungal medicine.
Maltese: Itraconazole huwa mediċina antifungali.
English: Fungitraxx is a veterinary medicine that contains the active substance itraconazole.
Maltese: Fungitraxx huwa mediċina veterinarja li fiha s-sustanza attiva itraconazole.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Fungitraxx on 12/03/2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Fungitraxx fi 12/03/2014.
English: A field study was performed with 62 birds with aspergillosis (cockatoos, parrots, parakeets, budgerigars, falcons, hawks, owls and swans) and 18 birds with candidiasis (cockatoos, parrots, parakeets and budgerigars).
Maltese: Sar studju fuq il-post b'62 għasfur b'asperġillosi (kakatuwi, pappagalli, parrukketti, amorini, falkuni, isqra, kokki u ċinji) u 18-il għasfur b'kandidjasi (kakatuwi, pappagalli, parrukketti u amorini).
English: It is given by mouth at a dose of 5 to 10 mg itraconazole per kg bodyweight each day for 8 weeks for aspergillosis, and 10 mg per kg daily for 2 weeks for candidiasis.
Maltese: Jingħata mill-ħalq f'doża ta' 5 sa 10 mg ta' itraconazole għal kull kg tal-piż talġisem kuljum għal 8 ġimgħat għal asperġillosi, u 10 mg għal kull kg kuljum għal ġimagħtejn għal kandidjasi.
English: It can be used to treat aspergillosis in cockatoos, parrots, parakeets, budgerigars, falcons, hawks, owls and swans, and also to treat candidiasis in cockatoos, parrots, parakeets and budgerigars.
Maltese: Jista' jintuża għall-kura ta' asperġillosi f'kakatuwi, pappagalli, parrukketti, amorini, falkuni, isqra, kokki u ċinji, u anki għall-kura ta' kandidjasi f'kakatuwi, pappagalli, parrukketti u amorini.
English: It works by blocking the production of a compound in the fungus called ergosterol which is an important part of fungal cell membranes.
Maltese: Jaħdem billi jimblokka l-produzzjoni ta' kompost fil-fungu msejjaħ ergosterol li huwa parti importanti tal-membrani taċ-ċelloli fungali.
English: The field study showed that Fungitraxx is effective in treating aspergillosis (with 56 out of 62 birds successfully treated) and candidiasis (with all birds successfully treated).
Maltese: L-istudju fuq il-post wera li Fungitraxx huwa effettiv fil-kura ta' asperġillosi (b'56 għasfur minn 62 kkurati b'suċċess) u kandidjasi (bl-għasafar kollha kkurati b'suċċess).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Fungitraxx exceed the risks for the approved indications and recommended that Fungitraxx be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Fungitraxx jisbqu r-riskji għall-indikazzjonijiet approvati u rrakkomanda li Fungitraxx jingħata awtorizzazzjoni għattqegħid fis-suq.
English: Fungitraxx is used to treat ornamental birds with two types of fungal infections of the respiratory tract (aspergillosis and candidiasis).
Maltese: Fungitraxx jintuża għall-kura ta' għasafar ornamentali b'żewġ tipi ta' infezzjonijiet fungali tal-passaġġ respiratorju (asperġillosi u kandidjasi).
English: For aspergillosis, birds were included if the presence of Aspergillus fungi in air sacs was confirmed and, for candidiasis, birds were included if clinical signs of candidiasis were present and infection was confirmed.
Maltese: Għal asperġillosi, l-għasafar kienu inklużi jekk il-preżenza tal-fungi Aspergillus kienet ikkonfermata fil-boroż tal-arja u, għal kandidjasi, l-għasafar kienu inklużi jekk kien hemm sinjali kliniċi ta' kandidjasi preżenti u konferma tal-infezzjoni.
English: What is Fungitraxx?
Maltese: Kif jaħdem Fungitraxx?
English: By blocking production of this compound, itraconazole leads to the breakdown of the fungal cells, killing the fungus or preventing it from spreading.
Maltese: Billi jimblokka l-produzzjoni ta' dan il-kompost, itraconazole iwassal għat-tkissir taċ-ċelloli fungali, joqtol il-fungu jew iwaqqfu milli jinfirex.
English: If suspected signs of disease (such as lumps or red pimples on the skin, or symptoms such as coughing or wheezing) appear in people a doctor should be consulted.
Maltese: Jekk ikun hemm suspett ta' sinjali tal-marda (bħal għoqod jew imsiemer ħomor fuq il-ġilda, jew sintomi bħal sogħla jew tħarħir) fin-nies għandu jiġi kkonsultat tabib.
English: Other information about Fungitraxx:
Maltese: Tagħrif ieħor dwar Fungitraxx:
English: In the case of accidental ingestion the mouth should be rinsed, medical advice sought immediately and the package leaflet or label shown to the doctor.
Maltese: Waqt l-immaniġġjar ta' għasafar infettati bl-asperġillosi, għandhom jintlibsu ingwanti tal-lattiċe u maskra biex jiġi evitat li l-marda tiġi trażmessa lill-persuna li tkun qed timmaniġġjahom.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ tal-benefiċċju-riskju jista' jinstab fil-modulu tad-diskussjoni xjentifika ta' dan lEPAR.
English: How has Fungitraxx been studied?
Maltese: Kif ġie studjat Fungitraxx?
English: What is the risk associated with Fungitraxx?
Maltese: Għaliex ġie appruvat Fungitraxx?
English: The full EPAR for Mircera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available in vials and in pre-filled syringes at various strengths ranging from 50 to 1,000 micrograms per millilitre.
Maltese: Huwa jiġi fi fjali u f'siringi mimlija minn qabel f'diversi dożaġġi minn 50 sa 1,000 mikrogramma kull millilitru.
English: In the studies of patients starting treatment for anaemia for the first time, 126 (93%) of the 135 patients on dialysis, and 158 (98%) of the 162 not on dialysis had a significant increase in haemoglobin levels with Mircera.
Maltese: Fl-istudji ta' pazjenti li bdew il-kura għall-anemija għall-ewwel darba 126 (93%) mill-135 pazjent fuq id-dijaliżi, u 158 (98%) mill-162 li ma kinux fuq id-dijaliżi kellhom żieda sostanzjali fil-livelli tal-emogolobina b'Mircera.
English: Mircera has been studied in six main studies involving a total of 2,399 adults with anaemia associated with chronic kidney disease.
Maltese: Mircera ġie studjat f'sitt studji ewlenin li involvew total ta' 2,399 adult b'anemija assoċjata mal-mard fil-kliewi fit-tul.