FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Xermelo (which may affect more than 1 in 10 people) are abdominal (belly) pain, increases in the liver enzyme gamma-glutamyl transferase, and tiredness, and are usually mild or moderate.
Maltese: L-effetti sekondarji l-aktar komuni bi Xermelo (li jistgħu jaffettwaw aktar minn persuna 1 minn 10) huma wġigħ addominali (żaqq), żidiet fl-enzima tal-fwied gamma-glutamyl transferase, u għeja, u normalment huma ħfief jew moderati.
English: Why is Xermelo approved?
Maltese: Għaliex ġie approvat Xermelo?
English: The benefits of adding Xermelo to treatment have been shown in one main study involving 135 patients with carcinoid syndrome whose diarrhoea had not been fully controlled with somatostatin analogues alone.
Maltese: Il-benefiċċji li jiżdied Xermelo mal-kura ntwerew fi studju wieħed ewlieni li kien jinvolvi 135 pazjent bis-sindrome karċinojde li d-dijarea tagħhom ma ġietx ikkontrollata b'mod sħiħ bl-analogi somatostatin waħedhom.
English: Because the number of patients with carcinoid syndrome is low, the disease is considered ‘rare', and Xermelo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 October 2009.
Maltese: Minħabba li l-għadd ta' pazjenti li għandhom is-sindrome karċinojde huwa baxx, il-marda hija kkunsidrata ‘rari', u Xermelo ingħata l-klassifikazzjoni ta' ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-8 ta' Ottubru 2009.
English: It is available as tablets containing 250 mg of telotristat and the recommended dose is one tablet three times a day.
Maltese: Jiġi bħala pilloli li fihom 250 mg ta' telotristat u d-doża rakkomandata hija pillola waħda tliet darbiet kuljum.
English: What are the risks associated with Xermelo?
Maltese: X'inhuma r-riskji assoċjati ma' Xermelo?
English: By blocking the enzymes, telotristat reduces the production of serotonin in patients with carcinoid syndrome, and so relieves the symptoms of the condition.
Maltese: Permezz tal-imblukkar tal-enzimi, it-telotristat inaqqas il-produzzjoni ta' serotonin f'pazjenti bis-sindrome karċinojde, u għalhekk itaffi s-sintomi tal-kundizzjoni.
English: At the start, patients given Xermelo had an average of 6.1 bowel movements per day, and this went down over the 12 weeks to an average of 4.7 per day, a reduction of 1.4 movements.
Maltese: Fil-bidu, il-pazjenti li ngħataw Xermelo kellhom medja ta' 6.1 movimenti fil-musrana kuljum, u dan naqas matul it-12-il ġimgħa għal medja ta' 4.7 kuljum, tnaqqis ta' 1.4 movimenti.
English: Xermelo is used together with other medicines, called somatostatin analogues, when those medicines are not sufficient on their own to control the diarrhoea.
Maltese: Xermelo jintuża flimkien ma' mediċini oħra, imsejħa analogi somatostatin, meta dawk il-mediċini waħedhom ma jkunux biżżejjed biex jikkontrollaw id-dijarea.
English: Xermelo is a medicine used to treat adults with severe diarrhoea associated with a condition called carcinoid syndrome.
Maltese: Xermelo huwa mediċina li tintuża biex tikkura adulti b'dijarea severa assoċjata ma' kundizzjoni bl-isem ta' sindrome karċinojde.
English: For the full list of all side effects and restrictions with Xermelo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha rrappurtati bi Xermelo, ara l-fuljett ta' tagħrif.
English: Xermelo was compared with placebo (a dummy treatment) and the main measure of effectiveness was the change in average number of daily bowel movements over the 12 weeks of the study.
Maltese: Xermelo tqabbel ma' plaċebo (kura finta) u l-kejl ewlieni tal-effikaċja kien il-bidla finnumru medju ta' movimenti fil-musrana ta' kuljum matul it-12-il ġimgħa tal-istudju.
English: The side effects that were seen, which mainly affected the gut, did not raise major concerns and were considered mild and manageable.
Maltese: L-effetti sekondarji li dehru, li primarjament affettwaw il-musrana, ma qajmux tħassib kbir u kienu kkunsidrati ħfief u maniġġevoli.
English: Xermelo has been shown to produce a reduction in the number of bowel movements suffered by patients with carcinoid syndrome not fully controlled with other medicines.
Maltese: Xermelo wera li jipproduċi tnaqqis fin-numru ta' movimenti fl-imsaren li jsofru l-pazjenti bis-sindrome karċinojde mhux ikkontrollata b'mod sħiħ b'mediċini oħra.
English: These enzymes are needed for the production of serotonin.
Maltese: Dawn l-enzimi huma meħtieġa għall-produzzjoni ta' serotonin.
English: The European Medicines Agency therefore decided that Xermelo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għaldaqstant, lAġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Xermelo huma akbar mir-riskji tiegħu u rrakkomandat li jkun approvat għall-użu fl-UE.
English: 29 May 2019
Maltese: 29 ta' Mejju 2019
English: EMA/293450/2019 EMEA/H/C/004938
Maltese: EMA/293450/2019 EMA/H/C/004938
English: Radicava is a medicine that contains the active substance edaravone.
Maltese: Radicava huwa mediċina li fiha s-sustanza attiva edaravon.
English: Withdrawal of the marketing authorisation application for Radicava (edaravone) EMA/293450/2019
Maltese: (edaravon) EMA/293450/2019
English: What is Radicava?
Maltese: X'inhu Radicava?
English: Radicava was expected to be used to treat patients with amyotrophic lateral sclerosis (ALS).
Maltese: Radicava kien mistenni li jintuża biex jikkura pazjenti bi sklerosi laterali amijotrofika (ALS).
English: Radicava was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 19 June 2015 for ALS.
Maltese: Radicava kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fid-19 ta' Ġunju 2015 għall-ALS.
English: ALS is a disease of the nervous system, where nerve cells in the brain and spinal cord that control voluntary movement gradually deteriorate, causing loss of muscle function and paralysis.
Maltese: L-ALS hija marda tas-sistema nervuża, fejn iċ-ċelluli tan-nervituri fil-moħħ u fil-korda spinali li jikkontrollaw ilmoviment volontarju jiddeterjoraw gradwalment, u jikkawżaw telfien tal-funzjoni tal-muskoli u paraliżi.
English: What was Radicava expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Radicava?
English: On 24 May 2019, Mitsubishi Tanabe Pharma GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Radicava intended for the treatment of amyotrophic lateral sclerosis (ALS).
Maltese: GmbH għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Radicava, maħsub għall-kura ta' sklerożi laterali amijotrofika (ALS).
English: Withdrawal of the marketing authorisation application for Radicava (edaravone)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat tqegħid fis-suq għal Radicava (edaravon)
English: It was to be available as a solution for infusion (drip) into a vein.
Maltese: Dan kellu jiġi bħala soluzzjoni għallinfużjoni (dripp) ġo vina.
English: The exact way Radicava works in patients with ALS is not known but it is thought to neutralise oxygencontaining molecules known as ‘free radicals', which have been linked to nerve damage in patients with ALS.
Maltese: Il-mod eżatt kif Radicava jaħdem fil-pazjenti bl-ALS mhux magħruf iżda huwa maħsub li jinnewtralizza l-molekuli li fihom l-ossiġnu magħrufa bħala ‘radikali liberi', li huma marbuta ma' ħsara fin-nervituri f'pazjenti bl-ALS.
English: The study looked at how much patients' symptoms changed over 24 weeks, using a standard rating scale known as ‘ALS functional rating scale revised'
Maltese: L-istudju ħares lejn kemm inbidlu s-sintomi tal-pazjenti matul 24 ġimgħa, bl-użu ta' skala ta' klassifikazzjoni standard magħrufa bħala ‘skala ta' klassifikazzjoni funzjonali riveduta tal
English: (ALSFRS-R).
Maltese: Kif jaħdem Radicava?
English: The company presented results from a main study of 137 patients with ALS who received either Radicava or placebo (a dummy treatment).
Maltese: Il-kumpanija ppreżentat riżultati minn studju ewlieni ta' 137 pazjent bl-ALS li ngħataw Radicava jew plaċebo (kura finta).
English: Furthermore, the CHMP noted important differences between the two groups which could have influenced the final results - such as the fact that a higher number of patients in the Radicava group had less severe disease.
Maltese: Barra minn hekk, is-CHMP innota differenzi importanti bejn iż-żewġ gruppi li setgħu influwenzaw irriżultati finali - bħall-fatt li għadd ogħla ta' pazjenti fil-grupp ta' Radicava kellhom mard inqas sever.
English: When patients in the placebo group were later switched to Radicava there was no noticeable effect.
Maltese: Meta l-pazjenti fil-grupp tal-plaċebo bdew jingħataw Radicava, ma kien hemm l-ebda effett evidenti.
English: The CHMP was also concerned about the duration of any benefits from Radicava, noting that 24 weeks (a cut-off point in the main study) was too short and that data from the extension phase of the study were difficult to interpret.
Maltese: Is-CHMP kien imħasseb ukoll dwar kemm dam kwalunkwe benefiċċju minn Radicava, u nnota li 24 ġimgħa (punt ta' qtugħ fl-istudju ewlieni) kien żmien qasir wisq u li d-data mill-fażi ta' estensjoni talistudju kienet diffiċli biex tiġi interpretata.
English: At the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Radicava could not have been approved.
Maltese: Fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Radicava ma setax jiġi approvat.
English: • The risk of formation of anti-C1INH antibodies and therefore the potential risk of formation of neutralising antibodies.
Maltese: • Ir-riskju ta' formazzjoni ta' antikorpi kontra C1INH u għalhekk ir-riskju potenzjali ta' formazzjoni ta' antikopri newtralizzati.
English: • Educational material for the physician.
Maltese: • Materjal edukattiv għal-tabib.
English: o A protocol for performing a skin prick test (SPT) with Ruconest and an intravenous test dosing schedule in patients with a negative skin prick test, including criteria for interpreting results, for patients with clinical features of cow's milk allergy.
Maltese: o Protokoll għal test ta' qarsa fil-ġilda (SPT) b'Ruconest u test ieħor fil-vina bl-iskeda tad-doża f'pazjenti li rriżultaw fin-negattiv għat-test ta' qarsa fil-ġilda, fosthom kriterji għallinterpretazzjoni tar-riżultati, għal pazjenti b'evidenza klinika għal allerġija għall-ħalib tal-baqra.
English: • The fact that Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins (Host Related Impurities, HRI).
Maltese: • Il-fatt li Ruconest ġej mill-ħalib ta' fniek transġeniċi u fih traċċi ta' proteini tal-fniek (Impuritajiet relatati mal-post li minnu ġejja s-sutanza, HRI).
English: • Prior to launch of the product in the Member State, the national competent authority shall agree the content and format of the educational material with the Marketing Authorisation Holder.
Maltese: • Qabel it-tnedija tal-prodott fl-Istat Membru, l-awtorità kompetenti nazzjonali għandha taqbel malkontenut u l-format tal-materjal edukattiv mad-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: o Information about the appropriate methodology to be used for laboratory testing of serum IgE antibodies against rabbit epithelium (dander)
Maltese: o L-informazzjoni fuq il-metodoloġija xierqa li trid tintuża fl-ittestjar tal-laboratorju tal-antikorpi tas-serum għall-IgE kontra l-epitelju (ix-xagħar) tal-fenek.
English: Advice about the immunogenicity laboratory testing program for these antibodies provided by the company for following up suspected emergence of neutralising antibodies and information about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Maltese: Konsultazzjoni fuq il-programm ta' ttestjar talimmunoġeneċità tal-laboratorju għal dawn l-antikorpi mogħtija mill-kumpanija sabiex ikun hemm segiwtu għal suspett ta' antikorpi newtralizzati emerġenti u informazzjoni rigward il-proċedura li trid tiġi segiwta waqt il-ġbir u l-ivvjaġġar ta' kampjuni tad-demm lejn il-laboratorju ċentrali talkumpanija.
English: • The need to inform patients about the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis, and that they should alert their physician if these symptoms occur.
Maltese: • Il-ħtieġa li l-pazjenti jkunu infurmati fuq is-sinjali tal-bidu ta' reazzjonijiet ta' ipersensittività fosthom ħorriċija, urtikarja ġeneralizzata, għafis tas-sider, nifs fit-tħarħir, ipotensjoni u anafilassi, u li huma jridu jinfurmaw lit-tabib minnufih jekk jidhru dawn is-sintomi.
English: • Copies of the patient card to be given to patients before they receive Ruconest
Maltese: • Kopji tal-karta tal-pazjent li trid tingħata lill-pazjenti qabel jingħataw Ruconest.
English: • That Ruconest is derived from milk of transgenic rabbits and contains trace of rabbit proteins
Maltese: • Li Ruconest huwa magħmul mill-ħalib ta' fniek transġeniċi u fih traċċi ta' proteini tal-fniek
English: • That they are receiving Ruconest for treatment of acute attack of hereditary angioedema
Maltese: • Li huma qed jingħataw Ruconest għall-kura ta' attakki gravi tal-anġjoedema ereditarja.
English: • That patients with clinical evidence of cow's milk allergy may have antibodies cross reacting with the rabbit milk impurities in Ruconest.
Maltese: • Li l-pazjenti li għandhom evidenza klinika ta' allerġija għall-ħalib tal-baqra jista' jkollhom antikorpi li jirreaġixxu mal-impuritajiet tal-ħalib tal-fenek f'Ruconest.
English: • The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to prescribe Ruconest are provided with an Educational pack.
Maltese: • Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jassigura li, ladarba lprodott ikun disponibbli għall-pubbliku, il-professjonisti kollha tal-qasam tas-saħħa li huma mistennija jippreskrivu Ruconest ikunu mogħtija pakkett edukattiv.
English: o Before initiating treatment with Ruconest all patients should be tested for the presence of IgE antibodies against rabbit epithelium (dander).
Maltese: • Il-karta tal-pazjent għandha tinkludi spazju riservat għall-pazjenti biex huma jkunu jistgħu jiktbu d-data u d-doża ta' kull trattament b'Ruconest (u jimmarkaw kull għaxar trattament).
English: • That Ruconest is contra indicated in all patients with known or suspected rabbit allergy or with positive serum IgE antibodies against rabbit dander due to the risk of major allergic reactions, therefore:
Maltese: • Li Ruconest huwa kontroindikat fil-pazjenti kollha li jafu li għandhom allerġija għall-fniek jew b'antikorpi ta' serum pożittiv IgE kontra x-xagħar tal-fniek minħabba r-riskju ta' reazzjonijiet allerġiċi kbar, għaldaqstant:
English: • The potential risk of an immune complex-mediated type III hypersensitivity reaction due to the formation of antibodies directed against Host Related Impurities (HRI).
Maltese: • Ir-riskju potenzjali ta' reazzjoni ipersensittiva tat-tip III immuna u medjament kumplessa minħabba l-formazzjoni ta' antikorpi diretti lejn l-impuritajiet relatati mal-post li minnu ġejja ssutanza (HRI). Konsultazzjoni fuq il-programm ta' ttestjar tal-immunoġeneċità tal-laboratorju għas-sorveljazzjoni ta' dawn l-antikorpi sabiex ikun hemm segiwtu għal marda immuna medjament kumplessa suspettata, u rigward il-proċedura li trid tiġi segiwta waqt il-ġbir u livvjaġġar ta' kampjuni tad-demm lejn il-laboratorju ċentrali tal-kumpanija.
English: • The importance of monitoring for clinical signs and symptoms of hypersensitivity and that patients should alert their doctor if they develop such symptoms during or after receiving Ruconest.
Maltese: • L-importanza tas-sorveljanza ta' sinjali kliniċi u sintomi ta' ipersensittività u li pazjenti għandhom jinfurmaw lit-tabib minnufih jekk jaraw tali sintomi matul jew wara li jingħataw Ruconest.
English: The full EPAR for Mycamine 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 contains the active substance micafungin.
Maltese: Fih is-sustanza attiva micafungin.
English: EPAR summary for the public micafungin
Maltese: Sommarju tal-EPAR għall-pubbliku micafungin
English: Other information about Mycamine
Maltese: Informazzjoni oħra dwar Mycamine
English: The most common side effects with Mycamine (seen in between 1 and 10 patients in 100) are leucopenia (low levels of leucocytes, a type of white blood cell), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), hypomagnesaemia (low blood magnesium levels), hypocalcaemia (low blood calcium levels), headache, phlebitis (inflammation of a vein), nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, signs of liver problems in the blood (increased levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase or bilirubin), rash, pyrexia (fever) and rigors (shaking chills).
Maltese: L-aktar effetti sekondarji komuni assoċjati ma' Mycamine (li deher f'bejn 1 u 10 pazjenti minn kull 100) kienu lewkopenija (livelli baxxi ta' lewkoċiti, tip ta' ċelloli tad-demm bojod), newtropenija (livelli baxxi ta' newtrofili, tip ta' ċelloli tad-demm bojod), anemija (għadd baxxi ta' ċelluli tad-demm ħomor), ipokaljemija (livelli baxxi ta' potassju fid-demm), ipomanjeżjemija (livelli baxxi ta' manjeżju fid-demm), ipokalċemija (livelli baxxi ta' kalċju fid-demm), uġigħ ta' ras, flebite (infjammazzjoni ta' vina), nawżea (dardir), remettar, dijarrea, uġigħ addominali (ta' żaqq), sinjali ta' problemi tal-fwied fid-demm (żieda fil-livelli ta' fosfatażi alkalina, aspartat aminotransferażi, alanina aminotransferażi jew bilirubina), raxx, piressija (deni) u rogħda (tertir).
English: The active substance in Mycamine, micafungin, is an antifungal medicine, which belongs to the group ‘echinocandins'.
Maltese: Is-sustanza attiva f'Mycamine, micafungin, hija mediċina antifungali, li tappartjeni għall-grupp 'ekinokandini'.
English: Mycamine was more effective than fluconazole in preventing fungal infection in patients undergoing a bone marrow transplant: 80% of the patients (340 out of 425) receiving Mycamine did not develop a fungal infection, compared with 74% of the patients (336 out of 457) receiving fluconazole.
Maltese: Mycamine kien aktar effikaċi minn fluconazole fil-prevenzjoni ta' infezzjoni fungali f'pazjenti li kienu sejrin jagħmlu trapjant tal-mudullun: 80% tal-pazjenti (340 minn 425) li rċevew Mycamine ma żviluppawx infezzjoni fungali, meta mqabbla ma' 74% tal-pazjenti (336 minn 457) li rċevew fluconazole.
English: Most of the patients in these two studies were infected with human immunodeficiency virus (HIV).
Maltese: Ħafna mill-pazjenti f'dawn iż-żewġ studji kienu infettati bil-virus ta' l-immunodefiċjenza umana (HIV).
English: This is a summary of the European public assessment report (EPAR) for Mycamine.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Mycamine.
English: • to treat invasive candidiasis (a type of fungal infection caused by a yeast-like fungus called
Maltese: • għat-trattament kandidjażi invażiva (tip ta' infezzjoni fungali minn fungus simili għall-ħmira imsejjaħ Candida).
English: For the treatment of oesophageal candidiasis, Mycamine was compared with fluconazole in a study involving 518 adults, and with caspofungin in another study involving 452 adults.
Maltese: Għat-trattament ta' kandidjażi tal-esofagu, Mycamine tqabbel ma' fluconazole fi studju li involva 518-il adult, u ma' caspofungin fi studju ieħor li involva 452 adult.
English: Why has Mycamine been approved?
Maltese: Għaliex ġie approvat Mycamine?
English: For the treatment of invasive candidiasis, Mycamine was compared with amphotericin B in a study involving 531 adults and 106 children, including newborns and premature babies.
Maltese: Għat-trattament ta' kandidjażi invażiva, Mycamine tqabbel ma' amphotericin B fi studju li kien jinvolvi 531 adult u 106 tifel/tifla, inkluż trabi tat-twelid u trabi prematuri.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mycamine on 25 April 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Mycamine valida madwar lUnjoni Ewropea kollha fil-25 ta' April 2008.
English: Additional common side effects in children (seen in between 1 and 10 children in 100) are thrombocytopenia (low blood platelet counts), tachycardia (rapid heart rate), hypertension (high blood pressure), hypotension (low blood pressure), hepatomegaly (enlarged liver), acute renal failure (sudden kidney failure) and increased blood urea levels.
Maltese: Effetti sekondarji komuni addizzjonali fit-tfal (li dehru f'bejn 1 u 10 itfal minn kull 100) huma tromboċitopenija (għadd baxxi ta' platelets fid-demm), takikardija (rata ta' taħbit tal-qalb mgħaġġla), ipertensjoni (pressjoni tad-demm għolja), ipotensjoni (pressjoni tad-demm baxxa), epatomegalija (tkabbir tal-fwied), insuffiċjenza renali (tal-fwied) akuta (f'daqqa) u żieda tal-urea fid-demm.
English: What is Mycamine?
Maltese: X'inhu Mycamine?
English: In the study of invasive candidiasis, around 90% of the adults receiving either Mycamine or amphotericin B were successfully treated.
Maltese: Fl-istudju tal-kandidjażi invażiva, madwar 90% ta' l-adulti li rċevew jew Mycamine jew amphotericin B ġew ittrattati b'suċċess.
English: What is the risk associated with Mycamine?
Maltese: X'inhu r-riskju assoċjat ma' Mycamine?
English: Treatment should be stopped if there are persistent increases in liver enzymes.
Maltese: It-trattament għandu jieqaf jekk ikun hemm żidiet persistenti fl-enzimi tal-fwied.
English: What measures are being taken to ensure the safe use of Mycamine?
Maltese: Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Mycamine?
English: ‘Invasive' means that the fungus has spread into tissue and blood vessels;
Maltese: 'Invażiva' tfisser li l-fungus infirex fit-tessut u fil-vini;
English: The medicine can only be obtained with a prescription.
Maltese: Mycamine kien effikaċi daqs il-mediċini tat-tqabbil fit-trattament tal-kandidjażi.
English: In the two studies of oesophageal candidiasis, around 90% of the patients were successfully treated with Mycamine, fluconazole or caspofungin.
Maltese: Fiż-żewġ studji ta' kandidjażi tal-esofogu, madwar 90% tal-pazjenti ġew ittrattati b'suċċess b'Mycamine, fluconazole jew caspofungin.
English: It works by interfering with the production of an essential component of the fungal cell wall called 1,3 β D glucan.
Maltese: Din taħdem billi tinterferixxi mal-produzzjoni tal-komponent essenzjali tal-wiċċ taċċellola fungali msejħa 1,3 β D glucan.
English: For the prevention of candidiasis, Mycamine was compared with fluconazole in 889 adults and children undergoing a bone marrow transplant.
Maltese: Għall-prevenzjoni ta' kandidjażi, Mycamine tqabbel ma' fluconazole fi 889 adult u tfal li jkunu se jagħmlu trapjant tal-mudullun.
English: The list of fungi against which Mycamine is active can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Il-lista ta' fungi li Mycamine huwa attiv kontrihom hija disponibbli fis-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Mycamine is used in babies, children and adults in the following situations:
Maltese: Mycamine jintuża fi trabi u adulti fis-sitwazzjonijiet li ġejjin:
English: Mycamine is a powder that is dissolved to make a solution for infusion (drip into a vein).
Maltese: Mycamine huwa trab li jdub sabiex isir soluzzjoni għal infużjoni (dripp fil-vina).