FrancophonIA/ELRC3.0 huggingface dataset:
English: * 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 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: Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 12).
Maltese: Rispons Viroloġiku Sostnut (SVR) huwa definit bħala HCV-RNA li ma jistgħux jitkejlu ma' l-24 ġimgħa wara l-kura (Tabella 12).
English: The 6 month treatment duration in this trial was better tolerated than one year of treatment in the pivotal combination trial; for discontinuation 5 % vs. 14 %, for dose modification 18 % vs. 49 %.
Maltese: Is-sitt xhur ta' kura ta' din il-prova kienu ttollerati aħjar minn fil-prova oriġinali bit-taħlita, għattwaqqif 5% vs 14%, għal tibdil fid-doża 18 % vs 49 %.
English: Respiratory, thoracic and mediastinal disorders Common:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna:
English: Genotype 2/3 88.9 (72/81)
Maltese: Ġenotip 2, 3 44 % (35/80)
English: Please refer also to the relevant product information for antiretroviral medicinal products.
Maltese: Jekk jogħġbok irreferi wkoll għall-informazzjoni rilevanti tal-prodott għal prodotti mediċinali antiretrovirali.
English: Suicidal ideation, psychosis, aggressive behaviour, confusion, agitation, anger, mood altered, abnormal behaviour, nervousness, sleep disorder, decreased libido, apathy, abnormal dreams, crying
Maltese: Ħsibijiet ta' suwiċidju, psikożi, imġieba aggressiva, konfużjoni, aġitazzjoni, rabja, tibdil fil-burdata, imġiba anormali, nervosità, disturbi ta' l-irqad, tnaqqis fil-libido, apatija, ħolm anormali, biki
English: Table 3 Management of Adverse Reactions Laboratory Values
Maltese: Tabella 3 Immaniġġjar ta' Reazzjonijiet Avversi
English: Ribavirin has been shown in preclinical studies to be teratogenic and genotoxic see section 4.4 and 5.3).
Maltese: Ribavirin intwera fi studji ta' qabel l użu kliniku li huwa teratoġeniku u ġenotossiku (ara sezzjonijiet 4.4 u 5.3).
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Klassi tas-Sistema ta' l-Organi
English: Adult patients with severe renal impairment (creatinine clearance of < 30 mL/minute) and patients with End Stage Renal Disease (ESRD) or on haemodialysis should be administered Ribavirin Mylan 200 mg/day.
Maltese: Pazjenti adulti b'indeboliment tal-kliewi sever (tneħħija tal-krejatinina ta' < 30 mL/minuta) u pazjenti b'Mard tal-Kliewi fl-Aħħar Stadju (ESRD, End Stage Renal Disease) jew fuq l-emodijaliżi għandhom jingħataw Ribavirin Mylan 200 mg/jum.
English: Although data are limited, no evidence of long-term effects on sexual maturation was noted in the 5 year observational follow-up study.
Maltese: Għalkemm id-dejta hi limitata, ma ġiet osservata l-ebda evidenza ta' effetti fit-tul fuq il-maturità sesswali fl-istudju follow-up ta' osservazzjoni ta' 5 snin.
English: Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and ribavirin when administered to paediatric patients with chronic hepatitis C Parameter
Maltese: Medja (% CV) parametri tal-farmakokinetiċi b'ħafna dożi għal interferon alfa-2b u kapsuli ribavirin meta jingħataw lil pazjenti pedjatriċi b'epatite C kronika Parametru
English: Adult patients: Ribavirin Mylan is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed (see section 5.1).
Maltese: Ribavirin Mylan hu indikat, flimkien ma' interferon alfa-2b, għall-kura ta' pazjenti adulti b'epatite Ċ kronika, li fil-passat kienu rrispondew (bin-normalizzazzjoni tal-ALT fit-tmiem talkura) għal interferon alfa mogħti waħdu, iżda li rkadew sussegwentement (ara sezzjoni 5.1).
English: The combination of Ribavirin Mylan with interferon alfa-2b is used in paedriatic patientes (children 3 years of age and older) who have chronic hepatitis C (HCV) infection.
Maltese: Il-kombinazzjoni ta' Ribavirin Mylan ma' interferon alfa-2b tintuża f'pazjenti pedjatriċi (tfal li għandhom 3 snin u aktar u aktar) li għandhom infezzjoni tal-epatite Ċ (HCV).
English: Patients were randomized to receive either ribavirin (800-1,200 mg/day based on weight) plus peginterferon alfa-2b (100 or 150 µg/week based on weight) or ribavirin (800-1,200 mg/day based on weight) plus interferon alfa-2b (3 MIU TIW).
Maltese: Il-pazjenti kienu randomized biex jirċievu ribavirin (800-1,200 mg/jum skont il-piż) ma' peginterferon alfa-2b (100 jew 150 µg/ġimgħa skont il-piż) jew ribavirin (800-1,200 mg/jum skont il-piż) ma' interferon alfa-2b (3 MIU TIW).
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b The safety of ribavirin is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied ribavirin capsules in combination with interferon alfa-2b, two trials studied ribavirin capsules in combination with peginterferon alfa-2b.
Maltese: Terapija doppja b'peginterferon alfa-2b jew interferon alfa-2b Is-sigurtà ta' ribavirin hija evalwata minn informazzjoni minn erba' studji kliniċi f'pazjenti li ma kellhom l-ebda esponiment għal interferon qabel (pazjenti naïve b'interferon): żewġ provi studjaw ribavirin kapsuli flimkien ma' interferon alfa-2b, f'żewġ provi sar studju b'ribavirin kapsuli flimkien ma' peginterferon alfa-2b.
English: Skin and subcutaneous tissue disorders Very common:
Maltese: Disturbi muskolu-skeltrali u tat-tessut konnettiv Komuni ħafna:
English: Table 6 Adverse reactions very commonly, commonly and uncommonly reported during clinical trials in children and adolescents with ribavirin in combination with interferon alfa-2b or peginterferon alfa-2b System Organ Class
Maltese: Reazzjonijiet avversi irrappurtati b'mod komuni ħafna, komuni jew mhux komuni waqt provi kliniċi fi tfal u adolexxenti b'ribavirin ma' interferon alfa-2b jew peginterferon alfa-2b
English: Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhoea, sneezing, pharyngolaryngeal pain
Maltese: Qtugħ ta' nifs, nifs imgħaġġel, epistassi, sogħla, konġestjoni nasali, irritazzjoni nasali, rajnorreja, għatis, uġigħ fil-farinġi u fillarinġi
English: Haematological abnormalities in HCV/HIV co-infected patients HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and cART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
Maltese: Pazjenti nfettati fl-istess ħin HCV/HIV li jkollhom ċirrożi fi stat avvanzat Pazjenti infettati fl-istess ħin li jkollhom ċirrożi avanzata u li jkunu qed jirċievu terapija kontra rretrovajrus kombinata (cART) jista' jkollhom riskju akbar ta' dikumpens tal-fwied u mewt.
English: Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted renally.
Maltese: Kemm Ribavirin u l-metaboli tiegħu triazole carboxymide u triazole carboxylic acids jitneħħew ukoll mill-kliewi.
English: c: Patients with genotype 3 low viral load (< 600,000 IU/ml) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/ml) were to receive 48 weeks of treatment.
Maltese: IU/ml) kellhom jieħdu 24 ġimgħa ta' kura fil-waqt li dawk b'ġenotip 3 u viral load għoli(≥ 600,000
English: Patients whose dose of Ribavirin Mylan is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Maltese: Il-pazjenti li d-doża tagħhom ta' Ribavirin Mylan titnaqqas għal 600 mg kuljum, jirċievu kapsula waħda ta' 200 mg filgħodu u żewġ kapsuli ta' 200 mg filgħaxija.
English: Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of Ribavirin Mylan therapy due to the long half-life (see section 5.2).
Maltese: Kwalunkwe possibbiltà ta' interazzjonijiet tista' tippersisti sa xaharejn (ħames half-lives għal ribavirin) wara l-waqfien tat-terapija b'Ribavirin Mylan minħabba l-half-life twil (ara sezzjoni 5.2).
English: The mechanism by which ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b exerts its effects against HCV is unknown.
Maltese: Il-mekkaniżmu li bih ribavirin flimkien ma' peginterferon alfa-2b jew interferon alfa-2b jeżerċita l-effetti tiegħu kontra HCV mhuwiex magħruf.
English: In children and adolescent patients receiving body surface area-adjusted dosing of peginterferon alfa-2b at 60 µg/m2/week, the log transformed ratio estimate of exposure during the dosing interval is predicted to be 58 % (90 % CI: 141-177 %) higher than observed in adults receiving 1.5 µg/kg/week.
Maltese: F'pazjenti tfal u adolexxenti li kienu qed jirċievu dożaġġi ta' peginterferon alfa-2b mibdula skont is-superfiċje tal-ġisem b'60 μg/m2/ġimgħa, l-istima tal-proporzjon ta' l-esponiment mibdul b'log waqt l-interval bejn iddożaġġi huwa mbassar li jkun 58 % (90 % CI: 141-177 %) ogħla minn dak osservat f'adulti li kienu qed jirċievu 1.5 μg/kg/ġimgħa.
English: Haemoglobin levels dropped below 10 g/dl in up to 14% of adult patients and 7% of children and adolescents treated with ribavirin in combination with either peginterferon alfa-2b or interferon alfa2b.
Maltese: Illivelli ta' l-emoglobina niżlu għal inqas minn 10 g/dl f'14 % tal-pazjenti adulti u 7 % ta' tfal u adolexxenti kkurati b'ribavirin flimkien ma' peginterferon alfa-2b jew ma' interferon alfa-2b.
English: There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e., not alfa-2b).
Maltese: M'hemmx informazzjoni dwar is-sigurtà jew l-effikacja fuq l-użu ta' ribavirin ma' forom oħra ta' interferon (i.e., mhux alfa-2b).
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA 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 C ikkonfermata mil-PCR (> 30 IU/ml) test pożittiv tal-HCV-RNA, bijopsija tal-fwied konsistenti ma' dijanjosi istoloġika ta' epatite kronika mingħajr l-ebda kawża oħra għall-epatite kronika u kwantitajiet anormali ta' ALT fis-serum.
English: Interferon alfa-2b (pegylated and non-pegylated) therapy may be initiated if TSH levels can be maintained in the normal range by medication.
Maltese: Terapija b'interferon alfa-2b (pegilat u mhux pegilat) tista' tinbeda jekk il-livelli ta' TSH ikunu jistgħu jinżammu fil-medda normali permezz talmedikazzjoni.
English: Multiple-dose pharmacokinetic properties for ribavirin and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 15.
Maltese: Il-karatteristiċi tal-farmakokinetiċi b'ħafna dożi għall-kapsuli ribavirin u interferon alfa-2b fi tfal u adolexxenti b'epatite C kronika ta' età bejn 5 u 16-il sena qed jintwerew fil-qosor f'Tabella 15.
English: interferon alpha/ribavirin peginterferon alpha/ribavirin
Maltese: Kif għandek tieħu Ribavirin Mylan
English: In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 15 mg/kg/day and 3 million international units (MIU)/m2 three times a week respectively (Table 1).
Maltese: Fi studji kliniċi li twettqu f'din il-popolazzjoni, ribavirin u interferon alfa-2b intużaw f'dożi ta' 15 mg/kg/kuljum u 3 miljun unità internazzjonali (MIU/m tliet darbiet fil-ġimgħa rispettivament
English: Patients were randomized to receive either ribavirin (800 mg/day) plus peginterferon alfa-2b (1.5 µg/kg/week) or ribavirin (800 mg/day) plus interferon alfa-2b (3 MIU TIW) for 48 weeks with a follow-up period of 6 months.
Maltese: Il-pazjenti kienu randomized sabiex jirċievu ribavirin (800 mg/jum) ma' peginterferon alfa-2b (1.5 µg/kg/ġimgħa) jew ribavirin (800 mg/jum) ma' interferon alfa-2b (3 MIU TIW) għal 48 ġimgħa b'perijodu ta' follow up ta' 6 xhur.
English: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
Maltese: Bijopsiji tal-fwied ittieħdu qabel u wara l-kura fi Studju 1 u kienu disponibbli għal 210 mill412 individwu (51 %).
English: Lower respiratory tract infection
Maltese: Disturbi gastro-intestinali
English: LABELLING AND PACKAGE LEAFLET
Maltese: Id-dehra ta' Ribavirin Mylan u d-daqs tal-pakkett
English: If the abnormality is reversed, ribavirin may be restarted at 600 mg daily, and further increased to 800 mg daily at the discretion of the treating physician.
Maltese: Jekk l-anormalità titreġġa' lura, ribavirin jista' jinbeda mill-ġdid f'doża ta' 600 mg kuljum, u jiżdied b'mod addizzjonali għal 800 mg kuljum fid-diskrezzjoni tat-tabib kuranti.
English: For BMI, pre-treatment to end of long-term follow-up, BMI-for-age percentiles decreased 1.8 and 7.5 percentiles among children treated for 24 weeks or 48 weeks, respectively.
Maltese: Għall-BMI, minn qabel il-kura sat-tmiem tal-follow-up fit-tul, ilpercentiles tal-BMI skont l-età naqsu b'1.8 u 7.5 percentiles fost tfal ikkurati għal 24 ġimgħa jew 48 ġimgħa, rispettivament.
English: The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation (> 15 percentile decrease in height percentile as compared to baseline) in 21 % (n=20) of children despite being off treatment for more than 5 years.
Maltese: Id-dejta fuq żmien itwal li hemm dwar tfal ikkurati bit-taħlita kombinata b'interferon/ribavirin standard jindikaw ukoll li jkun hemm ittardjar sostanzjali fir-rata ta' tkabbir (> 15 perċentwali tnaqqis fil-perċentwali tat-tul meta mqabbel mal-linja bażi) f'21% (n=20) tat-tfal minkejja li kienu ilhom aktar minn 5 snin li tneħħew minn fuq il-kura.
English: st dose reduction of Ribavirin Mylan is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day).
Maltese: el tnaqqis fid-doża ta' Ribavirin Mylan hu ta' 200 mg/kuljum (ħlief f'pazjenti li jkunu qed jirċievu 1,400 mg, it-tnaqqis fid-doża għandu jkun ta' 400 mg/kuljum).
English: • Genotypes Non-1: The decision to extend therapy to one year in patients with negative HCVRNA after six months of treatment should be based on other prognostic factors (e.g., age > 40 years, male gender, bridging fibrosis).
Maltese: • Ġenotipi Mhux 1: Id-deċizjoni biex il-kura tittawwal għal sena f'pazjenti li għandhom HCVRNA negattiv wara sitt xhur ta' kura, għandha tiġi bbażata fuq fatturi pronjostiċi oħra (eż. età ta' > 40 sena, sess maskili, fibrożi bridging).
English: Thyroid dysfunction during treatment with Ribavirin and interferon alfa-2b and during treatment with Ribavirin and peginterferon alfa-2b has been observed.
Maltese: Funzjoni ħażina tat-tirojde waqt il-kura b' ribavirin u interferon alfa-2b u waqt il-kura b' ribavirin u peginterferon alfa-2b kienet osservata.
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-ribavirin for co-HCV infection (see section 4.4).
Maltese: Tossiċità mitokondrijali u aċidożi lattika kienu rrappurtati f'pazjenti pożittivi għall-HIV li kienu qed jingħataw kors ta' NRTI flimkien ma' ribavarin għall-infezzjoni fl-istess ħin b'HCV (ara sezzjoni 4.4).
English: Forty-one percent of subjects (97/235) had nondetectable plasma HCV-RNA levels at week 4 and week 24 of therapy.
Maltese: Wieħed u erbgħin fil-mija ta' l-individwi (97/235) kellhom livelli ta' HCV-RNA li ma setgħux jitkejjlu mar-4 ġimgħa u ma' l-24 ġimgħa tat-terapija.
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, iperidrożi, akne, disturbi tal-ġilda, disturbi fid-dwiefer, il-ġilda titlef il-kulur, ġilda xotta, erytema, tbenġil
English: Ninety-four of 107 children enrolled in the 5 year long-term follow-up trial.
Maltese: Erba' u disgħin mill-107 tifel/tifla rreġistraw fil-prova follow-up fit-tul ta' 5 snin.
English: Another approximately 4% had a transient decrease below the lower limit of normal.
Maltese: Madwar 4 % oħra kellhom tnaqqis mumentanju taħt il-limitu ta' taħt tan-normali.
English: Rhabdomyolysis*, myositis*
Maltese: Doża ta' Ribavirin Mylan (ta' kuljum)
English: The incidence and severity of teratogenic effects increased with escalation of the dose.
Maltese: L-inċidenza u s-severità ta' l-effetti teratoġeniċi żdiedu maż-żieda fiddoża.
English: Patients who were HCV-RNA negative at Treatment week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
Maltese: Pazjenti li kienu HCV-RNA negattivi fit-12-il ġimgħa tal-Kura komplew il-kura għal 48 ġimgħa u kienu segwiti għal 24 ġimgħa wara l-kura.
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Maltese: Ittnaqqis fl-għadd ta' ċelluli CD4+ kien riversibbli bi tnaqqis tad-doża jew twaqqif tat-terapija.
English: Very commonly reported side effects (may affect more than 1 in 10 people): decreases in the number of red blood cells (that may cause fatigue, shortness of breath, dizziness), decrease in neutrophils (that make you more susceptible to different infections), decrease in thyroid gland activity (which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms), feeling depressed or irritable, feeling sick to stomach, feeling unwell, mood swings, tired feeling, trouble falling asleep or staying asleep, virus infection, weakness, diarrhoea, dizziness, fever, flu-like symptoms, headache, loss of or increase in appetite, loss of weight, decrease in the rate of growth (height and weight), pain on right side of ribs, pharyngitis (sore throat), shaking chills, stomach pain, vomiting, dry skin, hair loss, irritation, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Maltese: Effetti sekondarji rapportati komuni ħafna (jistgħu jaffettwaw iktar minn 1 minn kull 10 persuni): tnaqqis fin-numru ta' ċelluli ħomor tad-demm (li jista' jikkawża għeja, qtugħ ta' nifs, sturdament), tnaqqis fin-newtrofili (li jgħamluha aktar faċli li jaqbduk infezzjonijiet differenti), tbati biex tikkonċentra, tħossok anzjuż jew nervuż, tibdil fil-burdati, tħossok dipress jew irritabili, għajjien/a, problemi biex torqod jew biex tibqa' rieqed, sogħla fil-vojt, ħalq xott, farinġite (grieżem misluħa), dijarea, sturdament, temperatura għolja, sintomi bħal ta' l-influwenza, uġigħ ta' ras, dardir, dehxiet bi tregħid, infezzjoni virali, rimettar, dgħjufija, nuqqas t'aptit, tnaqqis fil-piż, uġigħ fl-istonku, ġilda xotta, irritazzjoni, jaqa'x-xagħar, ħakk fil-ġilda, weġgħat tal-muskoli, uġigħ fil-ġogi u filmuskoli, raxx.
English: • Increased hormone related to your thyroid (TSH) in children and adolescents
Maltese: • Żieda fl-ormoni relatati mat-tirojdi tiegħek (TSH) fit-tfal u l-adolexxenti
English: The recommended dose of Ribavirin Mylan combined with interferon alfa-2b or peginterferon alfa-2b, is shown in the below table.
Maltese: Id-doża rakkomandata ta' Ribavirin Mylan flimkien ma' interferon alfa2b jew peginterferon alfa-2b, hija murija fit-tabella t'hawn taħt.
English: Uncommonly reported side effects (may affect up to 1 in 100 people): abnormal behaviour, emotional disorder, fear, nightmare, bleeding of the mucous membrane that lines the inner surface of the eyelids, blurred vision, drowsiness, intolerance to light, itchy eyes, facial pain, inflamed gums, chest discomfort, difficult breathing, lung infection, nasal discomfort, pneumonia, wheezing, low blood pressure, enlarged liver, painful menstruation, itchy anal area (pinworms or ascarids), blistering rash (shingles), decreased sensitivity to touch, muscle twitching, pain in skin, paleness, peeling of skin, redness, swelling.
Maltese: Effetti sekondarji rapportati mhux komunement (jistgħu jaffettwaw sa 1 minn kull 100 persuna): imġiba anormali, disturbi emozzjonali, biża, ħolm ikraħ, fsada tal-membrana mukuża li tiksi s-superfiċje ta' gewwa ta' tebqet il-għajn, vista mċajpra, tħeddil, nuqqas ta' tolleranza għad-dawl, ħakk fl-għajnejn, uġigħ fil-wiċċ, ħanek iffjammat, skumdità fis-sider, tbatija biex tieħu n-nifs, infezzjonijiet fil-pulmun, skumdità fl-imnieħer, pnewmonja, tħarħir, pressjoni baxxa tad-demm, fwied imkabbar, uġigħ mestrwali, ħakk fiż-żona ta' l-anu (ħniex jew askaridi), raxx bi bżieżaq (ħruq ta' Sant' Antnin), tnaqqis fissensittività biex tħoss, ġbid muskolari, uġigħ fil-ġilda, ġilda pallida ġilda titqaxxar, ħmura, nefħa.
English: Ribavirin Mylan dose based on body weight when used in combination with interferon alfa-2b or peginterferon alfa-2b in children above 3 years of age and adolescents
Maltese: L-effetti sekondarji li ġejjin kienu irrappurtati bil-kombinazzjoni ta' din il-mediċina u prodott interferon alfa-2b fi tfal u adolexxenti:
English: If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Ribavirin and peginterferon alfa-2b or interferon alfa-2b be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Maltese: Jekk sintomi psikjatriċi jippersistu jew imorru għall-agħar, jew jinstab li hemm fissazzjoni ta' suwiċidju, huwa rrakkomandat li l-kura b' ribavirin u peginterferon alfa-2b jew b'interferon alfa-2b titwaqqaf, u l-pazjent jibqa taħt osservazzjoni, u jkun hemm support psikjatriku xieraq.
English: What Ribavirin Mylan is and what it is used for What you need to know before you take Ribavirin Mylan How to take Ribavirin Mylan Possible side effects
Maltese: Barra minn hekk dawn l-avveniment seħħew f'pazjenti li ħadu Ribavirin Mylan:
English: Thyroid supplemental monitoring specific for children and adolescents: Approximately 12% to 21% of children treated with Ribavirin and interferon alfa-2b (pegylated and non-pegylated) developed increase in thyroid stimulating hormone (TSH).
Maltese: Madwar 12 % sa 21 % tat-tfal ikkurati b'terapija kombinata b' ribavirin u interferon alfa-2b (pegilat u mhux pegilat) żviluppaw żieda fl-ormon li jistimula t-tirojde (TSH).
English: Retinopathy including retinal haemorrhages, retinal exudates, papilloedema, optic neuropathy and retinal artery or vein occlusion which may result in loss of vision have been reported in rare instances with combination therapy with alpha interferons.
Maltese: Retinopatija, inklużi emorraġiji retinali, tnixxijiet mir-retina, papillo-edema, newropatija ottika u sadda ta' l-arterja jew vina tar-retina li tista' twassal għat-telf tal-vista kienu rrappurtati f'xi każijiet b'terapija kkombinata ma' alfa interferons.
English: Conjunctival haemorrhage, eye pruritus, keratitis, vision blurred, photophobia Ear and labyrinth disorders
Maltese: Emorraġija mill-konġunktiva, ħakk fl-għajnejn, keratite, vista mċajpra, fotofobija
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with peginterferon alfa-2b (1.5 µg/kg)/ ribavirin combination therapy resulted in a higher sustained virologic response rate compared to peginterferon alfa-2b 1 µg/kg dose.
Maltese: F'pazjenti ta' nisel Afrikan-Amerikan (li huwa fattur ta' pronjożi magħruf għas-suċċess tat-tneħħija ta' l-HCV), kura b'terapija kombinata ta' peginterferon alfa-2b (1.5 µg/kg)/ribavirin wasslet għal rispons viroloġiku sostnut ogħla meta mqabbel ma' doża ta' peginterferon alfa-2b 1µg/kg.
English: The Ribavirin Mylan hard capsule is a white, opaque, hard capsule imprinted with green ink.
Maltese: Ir-Ribavirin Mylan kapsula iebsa hi kapsula iebsa, bajda, opaka, bi kliem stampat b'linka ħadra.