FrancophonIA/ELRC3.0 huggingface dataset:
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCVRNA polymerase chain reaction assay (PCR) (> 30 IU/mL), a liver biopsy consistent with a histological diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Maltese: Pazjenti eliġibbli għal dawn l-istudji kellhom epatite kronika Ċ ikkonfermata mill-assaġġ pożittiv permezz tal-polymerase chain reaction (PCR) (> 30 IU/mL) għal HCV-RNA, bijopsija talfwied konsistenti ma dijanjosi istoloġika ta' epatite kronika mingħajr l-ebda kawża oħra għall-epatite kronika u kwantitajiet anormali ta' ALT fis-serum.
English: d: Ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Maltese: 150 µg/ġimgħa peginterferon alfa-2b. d: dożaġġ ta' Ribavirin kien 800 mg għal pazjenti < 60 kg, 1,000 mg għal pazjenti 60-75 kg, u 1,200 mg għal pazjenti > 75 kg.
English: Limited safety data (N = 25) are available in co-infected patients with CD4+ cell counts < 200/µL (see section 4.4).
Maltese: Hemm tagħrif limitat (N = 25) dwar issigurtà f'pazjenti li jkollhom infezzjoni fl-istess ħin b'għadd ta' ċelluli CD4+ < 200/µL (ara sezzjoni
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: > 4 mg/dL (adults) * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, ribavirin dose should be reduced to 600 mg/day (administered as one 200 mg capsule in the morning and two 200 mg capsules in the evening).
Maltese: * Għal pazjenti li qed jirċievu doża ta' 1,000 mg (< 75 kg) jew 1,200 mg (> 75 kg), id-doża ta' ribavirin għandha titnaqqas għal 600 mg/jum (mogħtija bħala kapsula waħda ta' 200 mg filgħodu u żewġ kapsuli ta' 200 mg filgħaxija).
English: − hypersensitivity reaction to the medication
Maltese: Sensittività eċċessiva għal mediċina
English: Cardiac murmur * Since ribavirin has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or nonpegylated).
Maltese: Qalb tgedwed *Peress li ribavirin dejjem ġie preskritt bi prodott ta' alfa interferon u l-lista elenkata ta' reazzjonijiet avversi kienet tinkludi l-esperjenza ta' wara t-tqegħid fis-suq ma tippermettix kwantifikazzjoni preċiża tal-frekwenzi, il-frekwenza rapportata haw fuq hi mill-provi kliniċi meta ribavirin intuża flimkien ma' interferon alfa-2b (pergilat jew mhux pergilat)
English: Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, night sweats, hyperhidrosis, dermatitis, acne, furuncule*, erythema, urticaria, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder*
Maltese: Psorjasi, psorjasi aggravat, ekżema, reazzjoni ta' fotosensittività, raxx makulopapulari, raxx eritematsi, għaraq bil-lejl, iperidrosi, dermatite, akne, furunkulosi*, eritema, urtikarja, disturbi tal-ġilda, tbenġil, żieda fl-għaraq, tessut tax-xagħar mhux normali, disturbi fid-dwiefer*
English: The combination of Ribavirin Teva with interferon alfa-2b is used to treat patients 3 years of age and older who have chronic hepatitis C (HCV) infection.
Maltese: Il-kombinazzjoni ta' Ribavirin Teva ma' interferon alfa-2b tintuża biex jiġu kkurati pazjenti ta' mhux inqas minn 3 snin li għandhom epatite Ċ kronika (HCV).
English: However, absolute bioavailability is approximately 45 %-65 %, which appears to be due to first pass metabolism.
Maltese: Madankollu, ir-rata assoluta ta' bijodisponibilità hi madwar 45 %-65 %, li tidher li hi minħabba l-metaboliżmu talewwel passaġġ.
English: This should be discussed with your doctor (see “Do not take Ribavirin Teva”).
Maltese: Dan għandu jiġi diskuss mat-tabib tiegħek (ara “Tieħux Ribavirin Teva.”).
English: Mouth ulceration, stomatitis ulcerative, stomatitis, aphthous stomatitis, dyspepsia, cheilosis, glossitis, gastroesophageal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder, stomach discomfort, oral pain
Maltese: Ulċeri fil-ħalq, stomatite ulcerativa, stomatite, stomatite aftusa, dispepsja, kejlosi, glossite, rifluss gastroesofageali, disturbi fir-rektum, disturbi gastrointestinali, stitikezza, ippurhar merħi, uġigħ fis-snien, disturbi fis-snien, dwejjaq fl-istonku, uġigħ fil-ħalq
English: How to store Ribavirin Teva
Maltese: Kif taħżen Ribavirin Teva
English: − hepatitis,
Maltese: - Fertilità:
English: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite
Maltese: Ipergliċemija, iperurikemija, ipokalċemija, diżidrazzjoni, żieda fl-aptit
English: Both the Metavir score and Ishak grade decreased among subjects treated with ribavirin in combination with peginterferon alfa-2b.
Maltese: Trattament mill-ġdid ta' pazjenti li rkadew b'trattament kkombinat b'Ribavirin u interferon alfa-2b
English: Amnesia, memory impairment, syncope, migraine, ataxia, paraesthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, hypertonia, somnolence, disturbance in attention, tremor, dysgeusia
Maltese: Amnesija, indeboliment fil-memorja, sinkope, emigranja, atassja, tregħid, parestesija, disfonja, telf fit-togħma, ipoestesija, iperestesija, ipertonja, ngħas, disturbi flattenzjoni, rogħda, ipertonja, disgewsja
English: Based on published data, single-dose ribavirin pharmacokinetics was altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 mL/minute).
Maltese: Abbażi ta' dejta ippublikata, il-farmakokinetika ta' doża waħda ta' ribavirin kienet mibdula (żieda flAUCtf u Cmax) fpazjenti b'funzjoni ħażina tal-kliewi meta mqabbla mal-individwi bħala kontrolli (tneħħija ta' kreatinina > 90 mL/minuta).
English: − abnormal hair texture, acne, arthritis, bruising, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), hives, increased or decreased sensitivity to touch, nail disorder, muscle spasms, numbness or tingling feeling, limb pain, pain in joints, shaky hands, psoriasis, puffy or swollen hands and ankles, sensitivity to sunlight, rash with raised spotted lesions, redness of skin or skin disorder, swollen face, swollen glands (swollen lymph nodes), tense muscles, tumour (unspecified), unsteady when walking, water impairment.
Maltese: - nefħa, stitikezza, indiġestjoni, gass fl-imsaren (flatus), żieda fl-aptit, kolon irritat, irritazzjoni filglandola tal-prostata, suffejra (ġilda safranija), ippurgar maħlul, uġigħ fuq in-naħa tal-lemin madwar il-kustilji, fwied minfuħ, stonku mqallgħa' bżonn tagħmel pipi ta' spiss, tgaħddi aktar urina mis-soltu, infezzjoni fl-apparat urinarju, urina anormali. - pirjid menstruwali diffiċli, irregolari jew nieqes, pirjids menstruwali anormali qawwija u li jdumu, menstruwazzjoni bl-uġigħ, disturbi tal-ovarji jew vaġina, uġigħ fis-sider, problemi ta' impotenza, - għamla tax-xagħar anormali, akne, artrite, tbenġil, ekżema (infjammata, ħamra, bil-ħakk u ġilda xotta, bil-possibilita ta' feriti li jnixxu), urtikarja, żieda jew tnaqqis fis-sensittività għal mess, uġigħ fil-ġogi, idejn jitregħdu, psorjasi, idejn u l-għakkiesi minfuħin, sensitivita għad-dawl taxxemx, raxx bi ġrieħi mtebbgħa, ħmura tal-ġilda jew disturbi tal-ġilda, wiċċ minfuħ, glandoli minfuħin (għoqiedi linfatiċi minfuħin), muskoli mwebbsa, tumur (mhux speċifikat), żbilanċ meta timxi, indeboliment tal-ilma.
English: Thrombocytopenia, lymphadenopathy
Maltese: 6.3 Żmien kemm idum tajjeb il-prodott mediċinali
English: Preclinical data: - Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section 5.3).
Maltese: Fi studji fuq annimali, ribavirin ipproduċa effetti riversibbli fuq l-ispermatoġeneżi (ara sezzjoni 5.3). - Teratoġeniċità:
English: If you are a HCV/HIV co-infected adult patient receiving anti-HIV treatment, the addition of this medicine and peginterferon alfa-2b may increase your risk of worsening liver function combined antiretroviral therapy (cART) and increase your risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets) (NRTI).
Maltese: F'pazjenti koinfettati b'HCV/HIV li qed jirċievu cART, effetti kollaterali oħra li ġejjin seħħew bilkombinazzjoni ta' kapsuli iebsin ta' ribavirin u peginterferon alfa-2b (mhux elenkat hawn fuq fl-effetti sekondarji tal-adulti): - tnaqqis fl-aptit - uġigħ fid-dahar - tnaqqis fl-għadd ta' limfoċiti ta' CD4 - metaboliżmu difettuż tax-xaħam, - epatite, - uġigħ fid-dirgħajn/riġlejn - kandidijasi orali - anormalitajiet f'diversi riżultati tad-demm tal-laboratorju
English: Package leaflet: Information for the user Ribavirin Teva 200mg hard capsules ribavirin
Maltese: Informazzjoni għall-utent Ribavirin Teva 200 mg kapsuli iebsin ribavirin
English: Antacid
Maltese: Treddigħ
English: ≥ 2 g/dL decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction)
Maltese: Tnaqqis ta'  2 g/dL fl-emoglobina matul kwalunkwe perjodu ta' 4 ġimgħat waqt it-trattament (tnaqqis permanenti fid-doża)
English: Patients whose dose of Ribavirin Teva is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Maltese: Pazjenti li jkollhom id-doża ta' Ribavirin Teva tagħhom imnaqqsa għal 600 mg kuljum jirċievu kapsula waħda ta' 200 mg filgħodu u żewġ kapsuli ta' 200 mg filgħaxija.
English: The following side effects have been reported with children and adolescents taking ribavirin and interferon alfa-2b
Maltese: L-effetti sekondarji li ġejjin ġew rapportati fi tfal u adoloxxenti li qed jieħdu ribavirin u interferon alfa-2b
English: SVR after treatment of chronic HCV with interferon alfa-2b (pegylated and nonpegylated,with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical 'cure' from chronic HCV.
Maltese: SVR wara kura b'HCV kroniku b'interferon alfa-2b (pegilat u mhux pegilat, bi jew mingħajr ribavirin) wassal għal tneħħija fuq terminu ta' żmien twil tal-virus b'hekk tgħaddi linfezzjoni epatika ‘b'kura' klinika minn HCV kronika.
English: Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of ribavirin therapy due to the long half-life (see section 5.2).
Maltese: Kull possibilità ta' interazzjoni tista' tippersisti sa xaharejn (ħames half-lives għal ribavirin) wara lwaqfien tat-terapija b'ribavirin minħabba l-half-life twil (ara sezzjoni 5.2).
English: Ribavirin has been shown to produce high inter- and intra-subject pharmacokinetic variability following single oral doses (intrasubject variability of approximately 30 % for both AUC and Cmax), which may be due to extensive first pass metabolism and transfer within and beyond the blood compartment.
Maltese: Ribavirin intwera li jipproduċi varjabilità farmakokinetika għolja bejn u fl-individwi wara dożi waħidhom mill-ħalq (b'varjabilità ta' bejn l-individwi ta' madwar 30 % kemm għal AUC u għal Cmax), li għandha mnejn tkun minħabba l-metaboliżmu estensiv tal-ewwel passaġġ u t-trasferiment ġo u 'l barra mill-komportament tad-demm.
English: Pruritus, photosensitivity reaction, maculopapular rash, eczema, hyperhidrosis, acne, skin disorder, nail disorder, skin discolouration, dry skin, erythema, bruise
Maltese: Ħakk, reazzjoni ta' fotosensittività, raxx makulopapulari, ekżema, iperidrosi, akni, disturbi tal-ġilda, disturbi taddwiefer, tibdil fil-kulur tal-ġilda, ħakk, ġilda xotta, eritema, tbenġil
English: − bacterial infections, common cold, fungal infections, abnormal vision, dry or teary eyes, ear infection, eye irritation or pain or infection, change in taste, changes in your voice, cold sores, coughing, inflamed gums, nose bleed, nose irritation, oral pain, pharyngitis (sore throat), rapid breathing, respiratory infections, scaling lips and clefts in the corners of the mouth, shortness of breath, sinusitis, sneezing, sores in mouth, sore tongue, stuffy or runny nose, throat pain, toothache, tooth abscess, tooth disorder, vertigo (spinning feeling), weakness,
Maltese: - tnaqqis fl-għadd ta' ċelluli li jikkawżaw emboliżmu li jissejħu plejtlits (li tista' tirriżulta fi tbenġil faċli u emorraġija spontaeja, - livell eċċessiv ta' trigliċeridi fid-demm, livell eċċessiv ta' aċidu uriku (bħal fil-gotta), żieda flattività tal-glandola tat-tirojdi (li tista' tikkawża nervożità, intolleranza għas-sħana, u għaraq eċċessiv, telf fil-piż, palpitazzjonijiet, trgħid), - aġitazzjoni, rabja, mġieba aggressiva, disturbi ta' mġieba, diffikultà biex tikkonċentra, instabilità emozzjonali, sturdament, tħossok anzjuż jew nervuż, tħossok kiesaħ, tħossok konfuż, sensazzjoni ta' irrikwitezza, tħossok bi ngħas, nuqqas ta' interess, bidliet fil-burdata, uġigħ, irqad ta' kwalità baxxa, ħmar il-lejl, tentattiv ta' suwiċidju, diffiċli torqod,trid tweġġa' lilek innifsek, - infezzjonijiet batteriċi, riħ komuni, infezzjonijiet fungali, vista abnormali, għajnejn xotti jew biddmugħ, infezzjoni tal-widnejn, irritazzjoni tal-għajnejn jew uġigħ jew infezzjoni, bidla fit-togħma, bidliet kif tisma' l-vuċi tiegħek, ponot, sogħla, ħanek infjammat, imnieħer jinfaraġ, irritazzjoni flimnieħer, uġigħ fil-ħalq, farinġite (uġigħ fil-griżmejn), nifsijiet ta' malajr, infezzjonijiet respiratorji, xofftejn maqsuma, u klefts fil-ġnub tal-ħalq, nifsijiet qosra, sinusite, għatis, postumetti, uġigħ fl-ilsien, uġigħ fl-ilsien, imnieħer miżdud jew iqattar, uġigħ fil-griżmejn, uġigħ fis-snien, axxess tas-snien, disturbi tas-snien, vertiġini (tħoss rasek iddur bik, debbulezza, - uġigħ fis-sider, fwawar, palpitazzjonijiet (qalb tirbonbja), il-qalb tħabbat b'mod mgħaġġel - funzjoni anormali tal-fwied - rifluss tal-aċidu, uġigħ fid-dahar, ixxarrab fis-sodda, stitikezza, disturbi gastroesofaġeali jew rettali, inkontinenza, żieda fl-aptit, infjammazzjoni tar-riti tal-istonku u l-imsaren, l-istonku mqalla', ippurgar merħi, - disturbi fl-awrinazzjoni, infezzjoni tal-apparat urinarju, - pirjid menstruwali diffiċli, irregolari jew nieqes, pirjids menstruwali anormali qawwija u li jdumu, disturbi tal- vaġina, infjammazzjoni tal-vaġina, uġigħ fit-testikoli, żvilupp tal-karatteristiċi tarraġel fil-ġisem, - akne, tbenġil, ekżema (ġilda infjammata, ħamra, bil-ħakk u xotta, bil-possibilita ta' feriti li jnixxu),
English: In those patients that received > 10.6 mg/kg ribavirin (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received ≤ 10.6 mg/kg ribavirin (Table 7), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
Maltese: F'dawk ilpazjenti li rċevew > 10.6 mg/kg ribavirin (doża ta' 800 mg f'pazjent tipiku ta' 75 kg), hu x'inhu lġenotip jew il-viral load, ir-rati ta' rispons kienu ogħla b'mod sinifikanti f'dawk il-pazjenti li rċevew ≤ 10.6 mg/kg ribavirin (Tabella 7), filwaqt li r-rati ta' rispons f'pazjenti li rċevew > 13.2 mg/kg ribavirin kienu fil-fatt ogħla.
English: Patient weight (kg)
Maltese: Piż tal-ġisem (kg)
English: (kg)
Maltese: NUMRU(I)
English: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µL.
Maltese: Hemm tagħrif limitat disponibbli dwar l-effikaċja u s-sigurtà (N = 25) f'pazjenti li huma infettati flistess ħin b'HCV/HIV, b'għadd ta' CD4 ta' anqas minn 200 ċellula/µL.
English: Vertigo, hearing impaired/loss, tinnitus, ear pain
Maltese: Vertiġini, impediment/telf tas-smiegħ, tinnite, uġigħ filwidnejn
English: An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with ribavirin used in combination with peginterferon alfa-2b or interferon alfa2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy.
Maltese: Żieda fl-aċidu uriku u fil-valuri indiretti ta' bilirubin assoċjati ma' emoliżi kienet osservata f'xi pazjenti trattati b'ribavirin flimkien ma' peginterferon alfa-2b jew interferon alfa-2b fi provi kliniċi, imma l-valuri marru lura għal dawk tal-livelli bażi ta' riferiment wara erba' ġimgħat minn meta ntemmet it-terapija.
English: The safety of ribavirin capsules is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied ribavirin in combination with interferon alfa-2b, two trials studied ribavirin in combination with peginterferon alfa-2b.
Maltese: Is-sigurtà tal-kapsuli ribavirin hija evalwata minn tagħrif miġbur minn erba' studji kliniċi f'pazjenti li ma kellhom ebda esponiment għal interferon (pazjenti inkonsapevoli dwar interferon): żewġ provi studjaw ribavirin flimkien ma' interferon alfa-2b, żewġ provi studjaw ribavirin flimkien ma' peginterferon alfa-2b.
English: − abnormal liver function,
Maltese: Mhux applikabbli.
English: Laboratory values for HCV/HIV co-infected patients Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Maltese: Tnaqqis fl-emoglobina, ċelluli tad-demm bojod, plejtlits, newtrofili u żidiet filbilirubnin għandhom mnejn ikunu jeħtieġu tnaqqis fid-doża jew twaqqif permanenti tat-terapija (ara sezzjoni 4.2).
English: PHARMACEUTICAL FORM
Maltese: Teva Pharma
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Maltese: It-tnaqqis flgħadd ta' ċelluli CD4+ kien riversibbli bi tnaqqis tad-doża jew twaqqif tat-terapija.
English: Please refer to the corresponding SmPC of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with ribavirin.
Maltese: Jekk jogħġbok irreferi għall-SmPC korrispondenti ta' prodotti mediċinali li jintużaw flimkien ma' ribavirin għal effetti addizzjonali mhux mixtieqa rrappurtati b'dawn il-prodotti.
English: In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when ribavirin is administered.
Maltese: Filpopolazzjoni pożittiva għal HIV li qed jirċievu programm ta' trattament ta' NRTI, it-tobba għandhom josservaw b'attenzjoni l-markers ta' tossiċità mitokondrijali u aċidosi lattika meta jingħata ribavirin.
English: Ischaemic colitis
Maltese: Edema tal-wiċċ
English: Diabetes mellitus, hypertriglyceridemia*
Maltese: Dijabete mellitus, ipertrigliċeridemja
English: This summary was last updated in 02-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'02-2011.
English: Ribavirin Mylan is a ‘generic medicine'.
Maltese: Ribavirin Mylan huwa ‘mediċina ġenerika'.
English: The marketing authorisation holder is Generics [UK] Ltd.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq hu Generics [UK] Ltd.
English: The active substance in Ribavirin Mylan, ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Maltese: Is-sustanza attiva f'Ribavirin Mylan, ribavirin, hija antivirali li jappartjeni għall-klassi ta' ‘analogi ta' nukleoside'.
English: Previously known as Ribavirin Three Rivers
Maltese: Qabel kien magħruf bħala Ribavirin Three Rivers
English: The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Three Rivers on 10 June 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għal tqegħid fis-suq valida mal-UE kollha għal Ribavirin Three Rivers fil-10 ta' Ġunju 2010.
English: It is available as white capsules (200 mg).
Maltese: Jiġi bħala pilloli bojod, tawwalin (200 mg).
English: This document is a summary of the European Public Assessment Report (EPAR) for Ribavirin Mylan.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ribavirin Mylan.
English: What are the benefit and risk of Ribavirin Mylan?
Maltese: X'inhuma l-benefiċċju u r-riskju ta' Ribavirin Mylan?
English: The CHMP concluded that, in accordance with EU requirements, Ribavirin Mylan has been shown to have comparable quality and to be bioequivalent to Rebetol.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Ribavirin Mylan intwera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Rebetol.
English: Ribavirin Mylan must never be used on its own but only together with interferon alfa-2b (another medicine used in hepatitis).
Maltese: Ribavirin Mylan qatt ma għandu jintuża waħdu iżda biss ma' interferon alfa 2b (mediċina oħra użata fl-epatite).
English: Because Ribavirin Mylan is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Rebetol.
Maltese: Minħabba li Ribavirin Mylan hija mediċina ġenerika, studji f'pazjenti ġew limitati għal testijiet li jiddeterminaw li hija bijoekwivalenti għall-mediċina ta' referenza, Rebetol.
English: This means that Ribavirin Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Rebetol.
Maltese: Dan ifisser li Ribavirin Mylan huwa simili għall-'mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Rebetol.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar ilmediċini ġeneriċi, ara d-dokument ta' mistoqsija u tweġiba hawn.
English: Ribavirin Mylan is a medicine that contains the active substance ribavirin.
Maltese: Ribavirin Mylan hija mediċina li fiha s-sustanza attiva ribavirin.
English: Why has Ribavirin Mylan been approved?
Maltese: Għaliex ġie approvat Ribavirin Mylan?
English: What is Ribavirin Mylan?
Maltese: Għalxiex jintuża Ribavirin Mylan?
English: The name of the medicine was changed to Ribavirin Mylan on 27 January 2011.
Maltese: L-isem tal-mediċina nbidel f'Ribavirin Mylan fis-27 ta' Jannar 2011.
English: Other information about Ribavirin Mylan:
Maltese: Tagħrif ieħor dwar Ribavirin Mylan:
English: Ribavirin Mylan is used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Maltese: Ribavirin Mylan jintuża għat-trattament ta' epatite Ċ kronika (marda tal-fwied dovuta għal infezzjoni bil-virus tal-epatite C) f'pazjenti li għandhom minn tliet snin ‘l fuq.
English: Because Ribavirin Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Maltese: Minħabba li Ribavirin Mylan hija mediċina ġenerika u hija bioekwivalenti għall-mediċina ta' referenza, il-benefiċċju u r-riskju tagħha huma kkunsidrati li huma l-istess bħal tal-mediċina ta' referenza.
English: Ribavirin Mylan on its own has no effect on eliminating the hepatitis C virus from the body.
Maltese: Ribavirin Mylan waħdu ma għandu ebda effett fuq l-eliminazzjoni tal-virus tal-epatite Ċ mill-ġisem.
English: Ribavirin Mylan is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Maltese: Ribavirin Mylan huwa maħsub li jinterferixxi mal-produzzjoni jew mal-azzjoni ta' DNA u RNA virali, li huma meħtieġa sabiex il-virusijiet jissopravvivu u jimmultiplikaw.
English: The full EPAR for Solymbic 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.