FrancophonIA/ELRC3.0 huggingface dataset:
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Maltese: Anti-korp monoklonali huwa anti-korp (tip ta' proteina) li kien iddisinjat biex jagħraf u jeħel ma' struttura speċifika (magħrufa bħala antiġen) li tinsab f'ċerti ċelluli tal-ġisem.
English: LeukoScan has been studied in two main studies.
Maltese: LeukoScan ġie studjat f'żewġ studji prinċipali.
English: The main measure of effectiveness was the comparison of the diagnosis made using LeukoScan imaging with the diagnosis from bone biopsy histopathology and microbial culture (when a bone sample is taken and grown in a laboratory to see if it is carrying an infection).
Maltese: Il-kejl prinċipali ta' effikaċja kien ittqabbil tad-djanjosi magħmula bl-użu ta' l-imaging ta' LeukoScan bid-djanjosi mill-istopatoloġija ta' bijopsija ta' l-għadam u l-kultura mikrobika (meta jittieħed kampjun ta' l-għadam u jitkabbar f'laboratorju biex jiġi verfikat jekk hux qed iġorr infezzjoni).
English: Among these 232 patients, 158 had also undergone a scan using a standard scintigraphy technique (when the patient receives a specially prepared injection of their own white blood cells radiolabelled with a suitable radioactive marker).
Maltese: Fost dawn il-232 pazjent, 158 għamlu wkoll scan bl-użu ta' teknika sintigrafika standard (meta l-pazjent jirċievi injezzjoni preparata b'mod speċjali għaċ-ċelluli tad-demm bojod tagħhom stess radjutikkettati b'marker radjuattiv xieraq).
English: The Committee for Medicinal products for Human Use (CHMP) decided that LeukoScan's benefits are greater than its risks for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.
Maltese: Il-Kumitat għal prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benfiċċji ta' LeukoScan huma akbar mir-riskji tiegħu għad-determinazzjoni tas-sit u l-firxa ta' linfezzjoni/infjammazzjoni fl-għadam f'pazjenti b'suspett ta' osteomjelite, inkluż pazjenti b'ulċeri tassaqajn ikkawżati minn dijabete.
English: The radiolabelled solution is given as an intravenous injection, and a scintigraphy is carried out 1 to 8 hours later.
Maltese: Is-soluzzjoni radjutikkettata hija mogħtija bħala injezzjoni mill-vina, u mbagħad issir sintigrafija minn 1 sa 8 sigħat wara.
English: Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Maltese: Ir-radjutikkettar huwa teknika fejn sustanza tiġi tagged (ittikkettata) b'kompost radjuattiv.
English: Because LeukoScan has not been studied in patients aged 21 years or younger, doctors should carefully weigh the benefits and the risks of its use before administering it to a patient in this age group.
Maltese: Peress li LeukoScan ma ġiex studjat f'pazjenti ta' 21 sena jew inqas, it-tobba għandhom jgħarblu b'attenzjoni l-benefiċċji u r-riskji ta' l-użu tiegħu qabel jagħtuh lil pazjent f'dan il-grupp ta' età.
English: When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes.
Maltese: Meta l-mediċina radjutikkettata tiġi injettata fil-pazjent, l-antikorp monoklonali jġorr ir-radjuattività għallantiġen fil-mira fuq il-granuloċiti.
English: The full EPAR for LeukoScan is available here.
Maltese: EPAR sħiħ għal LeukoScan huwa disponibbli minn hawnhekk.
English: LeukoScan is used to find the site and extent of infection or inflammation in patients with suspected osteomyelitis (bone infection), including patients
Maltese: LeukoScan jintuża biex jinstab is-sit u lammont ta' infezzjoni jew infjammazzjoni f'pazjenti b'suspett ta' osteomyelitis (infezzjoni flgħadam), inkluż pazjenti b'ulċeri tas-saqajn ikkawżati minn dijabete.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra d-Diskussjoni
English: LeukoScan should not be used in people who may be hypersensitive (allergic) to sulesomab, mouse proteins, or any of the other ingredients.
Maltese: LeukoScan m'għandux jintuża f'persuni li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal sulesomab, proteini tal-ġrieden, jew għal xi sustanza oħra.
English: When the results of both studies were looked at together, LeukoScan was shown to be as effective in diagnosing bone infections as the biopsy and culture technique.
Maltese: Meta r-riżultati taż-żewġ studji ġew studjati flimkien, intwera li LeukoScan huwa effettiv fid-djanjosi ta' l-għadam daqs kemm hu effettiv fil-bijopsija u t-teknika tal-kultura.
English: London, 15 October 2009 EMEA/608943/2009
Maltese: Londra, 15 ta' Ottubru 2009 EMEA/608943/2009
English: Article 34 of Directive 2001/82/EC, as amended.
Maltese: Direttiva 2001/82/KE.
English: Tilmicosin is a chemically modified macrolide antibiotic with properties broadly similar to other macrolides.
Maltese: Tilmicosin huwa antibijotiku makrolidu modifikat kimikament b'karatteristiċi simili għal makrolidi oħra.
English: Pulmotil AC and associated names is a concentrate for oral solution whose active ingredient is tilmicosin with a strength of 250 mg/ml.
Maltese: Pulmotil AC u ismijiet assoċjati huwa konċentrat għal soluzzjoni orali li s-sustanza attiva hija tilmicosin f'doża ta' 250 mg/ml.
English: OPINION FOLLOWING AN ARTICLE 341 REFERRAL Pulmotil AC and associated names
Maltese: OPINJONI WARA REFERENZA SKONT L-ARTIKOLU 341 Pulmotil AC u ismijiet assoċjati
English: Written explanations were provided by the Marketing Authorization Holder on 12 January 2009 and supplementary information was submitted on 16 March 2009.
Maltese: Fit-12 ta' Jannar 2009 d-Detenturi talAwtorizzazzjoni għat-Tqegħid fis-Suq ipprovdew spjegazzjonijiet bil-miktub u informazzjoni addizzjonali ġiet sottomessa fis-16 ta' Marzu 2009.
English: Marketing Authorisations were granted in 18 Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures).
Maltese: L-awtorizzazzjonijiet għat-tqegħid fis-suq ingħataw fit-18-il Stat Membru tal-Unjoni permezz ta' proċeduri ta' awtorizzazzjoni differenti (proċeduri ta' għarfien bejn iż-żewġ naħat u proċeduri nazzjonali).
English: Oral explanations were given by the Marketing Authorisation Holder on 15 April 2009
Maltese: Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fisSuq taw l-ispjegazzjonijiet orali tagħhom nhar il-15 ta' April 2009.
English: Due to divergences (i.e. target species, indications for use, withdrawal periods, shelf life and environmental properties) amongst the nationally authorised Summary of Product Characteristics for Pulmotil AC and associated names, Germany referred the matter to the EMEA on 30 July 2008, under Article 34 of Directive 2001/82/EC.
Maltese: Minħabba d-diverġenzi (i.e. l-ispeċje fil-mira, indikazzjonijiet għall-użu, l-ammont li jrid jingħata u lperjodu ta' rtirar, iż-żmien kemm idum tajjeb il-prodott mediċinali u l-karatteristiċi ambjentali) fost lawtoritajiet nazzjonali s-Sommarju tal-Karatteristiċi tal-Prodott għal Pulmotil AC u ismijiet assoċjati,
English: Based on evaluation of currently available data and the rapporteur's assessment report, the CVMP considered that the benefit/risk profile of Pulmotil AC and associated names is positive subject to the recommended changes to the Summary of Product Characteristics and product information and therefore adopted an Opinion in May 2009 recommending amendments of the Marketing Authorisations.
Maltese: Skont il-valutazzjoni tad-dejta disponibbli attwalment u r-rapport tar-relatur, is-CVMP kkonsidra li lprofil ta' benefiċċju/riskju ta' Pulmotil AC u ismijiet assoċjati huwa pożittiv soġġett għall-bidliet irrakkomandati tal-Karatteristiċi tal-Prodott fil-Qosor u tal-informazzjoni dwar il-prodott u għaldaqstant adotta opinjoni f'Mejju 2009 li tirrakkomanda l-emendi tal-Awtorizzazzjoni għatTqegħid fis-Suq.
English: A revised Opinion, necessitated by purely administrative changes, was adopted by written procedure in July 2009.
Maltese: Opinjoni riveduta, meħtieġa minħabba bidliet purament amministrattivi, ġiet adottata f'Lulju 2009.
English: The referral procedure started on 16 September 2008.
Maltese: Il-proċedura ta' riferenza bdiet fis-16 ta' Settembru 2008.
English: The full EPAR and risk management plan summary for Zontivity 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: This summary was last updated in 07-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'07-2016.
English: Other information about Zontivity
Maltese: Informazzjoni oħra dwar Zontivity
English: Zontivity contains the active substance vorapaxar.
Maltese: Zontivity fih is-sustanza attiva vorapaksar.
English: Among patients with peripheral arterial disease, 10.9% (177 out of 1,622 patients) taking Zontivity had an atherothrombotic event compared with 12.5% (206 out of 1,651 patients) of patients taking placebo.
Maltese: Fost il-pazjenti li kellhom mard periferali fl-arterji, 10.9% (177 minn 1,622 pazjent) li ħadu Zontivity kellhom avveniment aterotrombotiku meta mqabbel ma' 12.5% (206 minn 1,651 pazjent) tal-pazjenti li ħadu plaċebo.
English: This is a summary of the European public assessment report (EPAR) for Zontivity.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zontivity.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zontivity on 19 January 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zontivity fid-19 ta' Jannar 2015.
English: The active substance in Zontivity, vorapaxar, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Zontivity, il-vorapaksar, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: What are the risks associated with Zontivity?
Maltese: X'inhuma r-riskji assoċjati ma' Zontivity?
English: Vorapaxar blocks the PAR-1 receptors (known as ‘thrombin receptors') on the surface of the platelets.
Maltese: Il-vorapaksar timblokka r-riċetturi PAR-1 (magħrufin bħala ‘riċetturi trombin' (thrombin receptors)) fuq il-wiċċ tal-pjastrini.
English: Zontivity is a medicine used to reduce the occurrence of atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes in adult patients who have already had a heart attack or who have peripheral arterial disease (problem with blood flow in the arteries) with symptoms.
Maltese: Zontivity huwa mediċina li tintuża biex tnaqqas l-okkorrenza ta' avvenimenti aterotrombotiċi (problemi kkawżati minn emboli tad-demm u għebusija fl-arterji) bħal attakki tal-qalb jew puplesiji f'pazjenti adulti li diġà kellhom attakk tal-qalb jew li jkollhom mard periferali fl-arterji (problema bil-fluss taddemm fl-arterji) bis-sintomi.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku vorapaksar
English: Zontivity was more effective than placebo at reducing the occurrence of atherothrombotic events.
Maltese: Zontivity kien iktar effettiv minn plaċebo fit-tnaqqis tal-okkorrenza ta' avvenimenti aterotrombotiċi.
English: Why is Zontivity approved?
Maltese: Għaliex ġie approvat Zontivity?
English: Overall, 9.5% of patients (1,259 out of 13,225 patients) taking Zontivity had an atherothrombotic event compared with 10.7% (1,417 out of 13,224 patients) of patients taking placebo.
Maltese: B'mod globali, 9.5% tal-pazjenti (1,259 minn 13,225 pazjent) li ħadu Zontivity kellhom avveniment aterotrombotiku meta mqabbel ma' 10.
English: In this group, 8.5% of patients (719 out of 8,458 patients) treated with Zontivity had an atherothrombotic event, compared with 10.3% of patients (867 out of 8,439 patients) on placebo.
Maltese: F'dan il-grupp, 8.5% tal-pazjenti (719 minn 8,458 pazjent) ikkurati b'Zontivity kellhom avveniment aterotrombotiku, meta mqabbel ma' 10.
English: The benefits of Zontivity were clearest in a group of 16,897 patients who had had a heart attack, but had no history of stroke or transient ischaemic attack (so-called ‘mini stroke').
Maltese: Il-benefiċċji ta' Zontivity kienu evidenti l-iktar fi grupp ta' 16,897 pazjent li kellhom attakk tal-qalb, iżda ma kellhomx storja ta' puplesija jew attakk iskemiku temporanju (hekk imsejjaħ ‘puplesija żgħira').
English: Zontivity is available as tablets (2 mg) and can only be obtained with a prescription.
Maltese: Zontivity jiġi bħala pilloli (2 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Zontivity was compared with placebo (a dummy treatment) in a main study involving over 26,000 adults who had had a heart attack or other atherothrombotic event or who had peripheral arterial disease.
Maltese: Zontivity tqabbel ma' plaċebo (kura finta) fi studju ewlieni li involva iktar minn 26,000 pazjent li kellhom attakk tal-qalb jew avveniment aterotrombotiku ieħor jew li kellhom mard periferali fl-arterji.
English: Blocking the PAR-1 receptor stops the platelets becoming sticky, reducing the risk of a blood clot forming and helping to prevent a stroke or heart attack.
Maltese: L-imblokkar tar-riċettur PAR-1 iwaqqaf il-pjastrini milli jsiru jwaħħlu, inaqqas ir-riskju li jifforma embolu tad-demm u jgħin jipprevjeni puplesija jew attakk tal-qalb.
English: How is Zontivity used?
Maltese: Kif jintuża Zontivity?
English: Regarding Zontivity's safety profile, the CHMP was concerned about the risk of bleeding in patients taking Zontivity on top of their standard therapy, particularly serious bleeding which was more frequent in patients with a history of stroke.
Maltese: Fir-rigward tal-profil tas-sigurtà ta' Zontivity, is-CHMP kien imħasseb dwar ir-riskju ta' fsada f'pazjenti li jieħdu Zontivity apparti t-terapija standard tagħhom, b'mod partikolari fsada serja li hija iktar frekwenti f'pazjenti li għandhom storja ta' puplesija.
English: However, as patients with peripheral arterial disease have a high risk of atherothrombotic events and the treatment options for prevention of these events are limited, the CHMP considered that Zontivity's benefits are greater than its risks for this condition.
Maltese: Madankollu, peress li pazjenti b'mard periferali fl-arterji jkollom riskju għoli ta' avvenimenti aterotrombotiċi u l-għażliet ta' kura għall-prevenzjoni ta' dawn lavvenimenti huma limitati, is-CHMP ikkunsidra li l-benefiċċji ta' Zontivity huma akbar mir-riskji tiegħu għal din il-kondizzjoni.
English: The medicine has been shown to be beneficial in reducing the number of atherothrombotic events in patients who had had a heart attack.
Maltese: Il-mediċina intweriet li hija ta' benefiċċju fit-tnaqqis tan-numru ta' avvenimenti aterotrombotiċi f'pazjenti li kellhom attakk talqalb.
English: There are limited data on the use of Zontivity for longer than 2 years; therefore, after 2 years of treatment, the benefits and risks of Zontivity should be re-evaluated in individual patients by the treating doctor.
Maltese: Hemm data limitata dwar l-użu ta' Zontivity għal aktar minn sentejn; għalhekk, wara sentejn ta' kura, il-benefiċċji u r-riskji ta' Zontivity għandhom jiġu evalwati mill-ġdid f'pazjenti individwali mit-tabib li jkun qed jagħti l-kura.
English: Nearly all patients also took aspirin and/or another medicine to prevent atherothrombotic events, and were treated for at least a year.
Maltese: Kważi l-pazjenti kollha ħadu wkoll aspirina u/jew mediċina oħra biex jipprevjenu avvenimenti aterotrombotiċi, u ġew ikkurati għal mill-inqas sena.
English: It is given in combination with aspirin (acetylsalicylic acid) and where appropriate with a third medicine, clopidogrel, both of which also help prevent atherothrombotic events.
Maltese: Jingħata flimkien mal-aspirina (aċidu aċetilsaliċiliku) u meta jkun meħtieġ ma' tielet mediċina, clopidogrel, li t-tnejn li huma wkoll jgħinu biex jipprevjenu avvenimenti aterotrombotiċi.
English: In patients with peripheral arterial disease, the data showed a benefit for patients taking Zontivity, although the number of atherothrombotic events reported during the main study was not large enough to enable conclusive results.
Maltese: F'pazjenti b'mard periferali fl-arterji, id-data wriet benefiċċju għall-pazjenti li jieħdu Zontivity, għalkemm in-numru ta' avvenimenti aterotrombotiċi rrapportati matul l-istudju ewlieni ma kienx kbir biżżejjed biex jippermetti riżultati konklużivi.
English: It is given in combination with aspirin and where appropriate, clopidogrel.
Maltese: Jingħata flimkien mal-aspirina u fejn xieraq, ma' clopidogrel.
English: Thrombin is one of the substances involved in the clotting process, and when it attaches to the PAR-1 receptor it causes the platelets to become ‘sticky', helping the blood clot to form.
Maltese: Trombin hija waħda mis-sustanzi involuti fil-proċess tal-għaqid, u meta teħel mar-riċettur PAR-1 iġġiegħel lill-pjastrini sabiex isiru ‘jwaħħlu', u jgħinu biex jifforma l-embolu tad-demm.
English: 1 bottle + 1 bottle adaptor + 2 oral syringes
Maltese: 1 bottle + 1 bottle adaptor
English: Oral suspension Oral use bottle (glass); syringe (PET)
Maltese: Sospensjoni orali Użu Orali flixkun (ħġieġ); siringa (PET)
English: Content (concentration)
Maltese: Ippakkjar Kontenut (konċentrazzjoni)
English: EMEA Number (Invented) name
Maltese: Numru tal-EMA Isem (ivvintat)
English: The full EPAR for Evalon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Evalon avian coccidiosis vaccine (live)
Maltese: Evalon tilqima għall-avian coccidiosis (ħaj)
English: Evalon is a veterinary vaccine to protect chickens against coccidiosis caused by the coccidia parasites Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Maltese: Evalon huwa mediċina veterinarja sabiex tipproteġi t-tiġieġ kontra kokkidijożi ikkawżat minn parassiti coccidia Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix u Eimeria tenella.
English: Evalon is a vaccine.
Maltese: Evalon huwa tilqima.
English: This is a summary of the European public assessment report (EPAR) for Evalon.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Evalon.
English: Other information about Evalon?
Maltese: Informazzjoni oħra dwar Evalon?
English: The vaccine contains live attenuated (weakened) oocysts of Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix and Eimeria tenella.
Maltese: It-tilqima fiha ooċisti (imdgħajfa) attenwati ħajjin ta' Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix u Eimeria tenella.
English: Infected birds shed disease spores (oocysts) in their faeces that can spread the infection.
Maltese: Għasafar infettati iwaqqgħu spori tal-mard (ooċisti) fl-ippurgar tagħhom li jistgħu jferrxu l-infezzjoni.
English: This will help protect against coccidiosis.
Maltese: Dan jgħin jipproteġihom kontra l-kokkidijożi.
English: Protection starts at 3 weeks after vaccination and lasts until 60 weeks after vaccination.
Maltese: Il-protezzjoni tibda fi 3 ġimgħat wara t-tilqima u tibqa' sa 60 ġimgħa wara t-tilqima.
English: Why is Evalon approved?
Maltese: Għaliex ġiet approvat Evalon?
English: What are the risks associated with Evalon?
Maltese: X'inhuma r-riskji assoċjati ma' Evalon?
English: The results with Evalon and the comparator vaccine were similar for 3 out 4 farms; on 1 farm Evalon vaccinated chickens showed better protection than those given the comparator.
Maltese: Ir-riżultati b'Evalon u t-tilqima komparatur kienu simili għal 3 minn 4 irziezet; f'razzett wieħed it-tiġieġ imlaqqam b'Evalon urew protezzjoni aħjar minn dawk mogħtija l-komparatur.
English: In a field study involving 4 farms, shedding of oocysts in the faeces was reduced within 3 weeks of vaccination both in Evalon vaccinated chicks and those vaccinated with another vaccine against Eimeria.
Maltese: Fi studju fuq il-post li involva 4 irziezet, it-twaqqigħ tal-ooċisti fl-ippurgar tnaqqas fi żmien 3 ġimgħat tat-tilqima kemm fil-flieles imlaqqma b'Evalon kif ukoll f'dawk imlaqqma b'tilqima oħra kontra l-Eimeria.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: It-tilqimiet jaħdmu billi "jgħallmu" lis-sistema immunitarja (id-difiżi naturali tal-ġisem) kif tiddefendi ruħha kontra l-mard.
English: MA (EU) Numbers (Invented) name Strength
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Immediate Packaging Pack size blister (PVC/PVDC-Alu); wallet blister (PVC/PVDC-AluAlu); carton
Maltese: Daqs tal-pakkett folja (PVC/PVDC/Alu); kartiera pakkett għalltrattament tal-bidu: 28 pilloli (7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa
English: EMA/858611/2015 EMEA/H/C/004134
Maltese: EMA/858611/2015 EMA/H/C/004134
English: • invasive candidiasis (a type of fungal infection due to Candida);
Maltese: • kandidjażi invażiva (tip ta' infezzjoni fungali dovuta għal Candida);
English: The full EPAR and risk management plan summary for Caspofungin Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Caspofungin Accord jistgħu jinstabu fissit web tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Caspofungin Accord is a ‘generic medicine'.
Maltese: Caspofungin Accord huwa ‘mediċina ġenerika'.
English: In adults, treatment begins with a 70mg starting dose, followed by a daily dose of 50 mg, or of 70 mg if the patient weighs more than 80 kg. A lower dose is given to adults who have moderate problems with their liver.
Maltese: Fl-adulti, il-kura tibda b'doża tal-bidu ta' 70 mg, segwita minn doża ta' kuljum ta' 50 mg, jew ta' 70 mg jekk il-pazjent jiżen aktar minn 80 kg.
English: This is a summary of the European public assessment report (EPAR) for Caspofungin Accord.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Caspofungin Accord.
English: • invasive aspergillosis (another type of fungal infection due to Aspergillus) when the infection does not respond to or the patient does not tolerate amphotericin B or itraconazole (other antifungal medicines);
Maltese: • asperġillożi invażiva (tip ieħor ta' infezzjoni fungali dovuta għal Aspergillus), meta l-pazjent ma jirrispondix għal jew ma jittollerax l-amfoteriċina B jew itraconazole (mediċini antifungali oħrajn);
English: It contains the active substance caspofungin.
Maltese: Huwa fih is-sustanza attiva caspofungin.
English: Caspofungin Accord is an antifungal medicine used to treat adults, adolescents and children with:
Maltese: Caspofungin Accord huwa mediċina antifungali użata sabiex tikkura l-adulti, l-adolexxenti u t-tfal bi:
English: The company provided data from the published literature on caspofungin.
Maltese: Il-kumpanija pprovdiet data minn dokumentazzjoni ppubblikata dwar il-caspofungin.
English: The active substance in Caspofungin Accord, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins'.
Maltese: Is-sustanza attiva f'Caspofungin Accord, il-caspofungin, tappartjeni għal grupp ta' mediċini antifungali magħrufin bħala ‘ekinokandini' (echinocandins).
English: Caspofungin Accord caspofungin
Maltese: Aktar informazzjoni dwar Caspofungin Accord
English: It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide', which is necessary for the fungus to survive and grow.
Maltese: Din taħdem billi tinterferixxi mal-produzzjoni ta' komponent tal-ħajt taċ-ċellula fungali ‘glucan polysaccharide', li hija meħtieġa sabiex il-fungu jkompli jgħix u jikber.