FrancophonIA/ELRC3.0 huggingface dataset:
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Maltese: Din l-attività tista' twassal għal riskju akbar ta' aċidożi lattika kkaġunata minn analogi ta' nucleoside tal-purina (eż. didanosine jew abacavir).
English: Patients with creatinine clearance < 50 ml/minute must not be treated with ribavirin (see section 4.3).
Maltese: Pazjenti li għandhom rata ta' tneħħija ta' kreatinina ta' < 50 ml/minuta m'għandhomx jiġu trattati b'ribavirin (ara sezzjoni 4.3).
English: Ribavirin BioPartners 200 mg film-coated tablets ribavirin
Maltese: Ribavirin BioPartners 200 mg pilloli miksija b'rita ribavirin
English: Palpitation, tachycardia
Maltese: Takikardija, palpitazzjonijiet
English: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Maltese: Disturbi fis-sistema riproduttiva u tas-sider Nisa: amenorrea, menorraġja, disturbi menstruwali, Irġiel: uġigħ testikulari
English: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Maltese: Minbarra hekk, 98 % (51/52) b'livelli ALT normali mal-ġimgħa 24 ta' follow-up żammew livelli ta' ALT normali sa l-aħħar żjara tagħhom.
English: Acute hypersensitivity: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin must be discontinued immediately and appropriate medical therapy instituted.
Maltese: Jekk tiżviluppa reazzjoni ta' sensittività eċċessiva akuta (eż. urtikarja, anġjodema, jidjiequ l-bronki, anafilassi), Ribavirin għandu jitwaqqaf minnufih u tinbeda terapija medika xierqa.
English: Retreatment of relapse patients with ribavirin and interferon alfa-2b combination treatment Two trials examined the use of ribavirin and interferon alfa-2b combination treatment in relapse patients (C95-144 and I95-145); 345 chronic hepatitis patients who had relapsed after previous interferon treatment were treated for six months with a six month follow-up.
Maltese: Trattament mill-ġdid ta' pazjenti li rkadew b'trattament kkombinat b'ribavirin u interferon alfa-2b Żewġ studji li eżaminaw l-użu kkombinat ta' ribavirin u interferon alfa-2b f'pazjenti li jirkadu (C95-144 u I95-145); 345 pazjent b'epatite kronika li kienu diġà rkadew b'trattament ta' interferon li ngħata qabel, kienu ttrattati għal sitt xhur ta' follow-up.
English: Table 3 Dosage modification guidelines based on laboratory parameters Reduce only interferon alfa-2b dose (see note 2) if:
Maltese: Tabella 3 Linji gwida għal modifikazzjonijiet fid-dożaġġ skont parametri tal-laboratorju Naqqas id-doża ta' interferon alfa-2b biss (ara nota 2), jekk:
English: Hepatomegaly, jaundice, hyperbilirubinemia* Hepatotoxicity (including fatalities)* Skin and subcutaneous tissue disorders Alopecia, pruritus, skin dry, rash Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, night sweats, hyperhidrosis, dermatitis, acne, furuncule, erythema, urticaria, skin disorder, bruise, sweating increased, abnormal
Maltese: Epatomegalija, suffejra, iperbilirubinemija* Epatotossiċita (li jinkludi mewt)* Disturbi fil-ġilda u fit-tessut ta' taħt il-ġilda Alopeċja, ħakk, ġilda xotta, raxx Psorjasi, psorjasi aggravat, ekżema, reazzjoni ta' fotosensittività, raxx makulopapulari, raxx eritematsi, issir għarqab bil-lejl, iperidrożi, dermatite, akne, furunklu, eritema, urtikarja, disturb ital-ġilda, tbenġil, żieda fl-għaraq, tessut tax-xagħar mhux normali, disturbi fid-dwiefer*
English: Ribavirin BioPartners must be used in combination with interferon alfa-2b.
Maltese: Ribavirin BioPartners għandu jintuża kombinat ma' interferon alfa-2b.
English: Adult patients: Ribavirin BioPartners is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA (see section 4.4).
Maltese: Ribavirin BioPartners huwa indikat għall-użu, flimkien ma' interferon alfa-2b, għal trattament f'pazjenti adulti bit-tipi kollha ta' epatite Ċ kronika ħlief ġenotip 1, li ma kienux ikkurati qabel, mingħajr fwied mhux kompensat, b'alanine aminotransferase (ALT) għoli, li huma pożittivi għal ribonucleic acid virali HCV-RN) ta' epatite Ċ (ara sezzjoni 4.4).
English: Note 2: In adult patients and children and adolescent patients treated with Ribavirin BioPartners plus interferon alfa-2b, reduce the interferon alfa-2b dose by one-half dose.
Maltese: Nota 2: F'pazjenti adulti u tfal u adolexxenti ikkurati b'Ribavirin BioPartners ma' interferon alfa-2b, naqqas id-doża ta' interferon alfa-2b b'nofs id-doża.
English: In clinical trials with ribavirin used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of ribavirin (50 x 200 mg) and 39 MIU of interferon alfa-2b (13 subcutaneous injections of 3 MIU each) taken in one day by a patient in an attempt at suicide.
Maltese: Fi studji kliniċi b'ribavirin li intuża flimkien ma' peginterferon alfa-2b jew interferon alfa-2b, id-doża eċċessiva massima rrappurtata kienet doża totali ta' 10 g ta' ribavirin (50 x 200 mg) u 39 MIU ta' interferon alfa-2b (13 injezzjonijiet taħt il-ġilda ta' 3 MIU each) meħuda f'ġurnata waħda minn pazjent f'tentattiv ta' suwiċidju.
English: Therefore, there is a minimal potential for P450 enzyme-based interactions.
Maltese: Għalhekk, hemm probabilità minima li jseħħu interazzjonijiet bażati fuq l-enżima P450.
English: Upon multiple dosing, ribavirin accumulates extensively in plasma with a six-fold ratio of multiple-dose to single-dose AUC12hr.
Maltese: Wara dożaġġ multiplu, ribavirin jakkumula b'mod estensiv fil-plażma bi proporzjon ta' sitt darbiet ta' doża multipla għal kull doża ta' AUC12hr.
English: Bacterial infection (including sepsis), fungal infection, influenza, respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis, urinary tract infection
Maltese: Infezzjoni bil-batteri (inkluża sepsi), infezzjoni bil-fungu, influwenza, infezzjoni tal-passaħħ tan-nifs, bronkite, herpes simplex, sinusite, otitis media, flissjoni, infezzjoni fil-passaġġ awrinarju
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1,000 to < 1/100).
Maltese: Fil-klassijiet ta-sistema tal-organi, ir-reazzjonijiet avversi huma elenkati taħt titli ta' frekwenza bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa <1/10) u mhux komuni (≥ 1/1,000 sa' < 1/100).
English: Depression, insomnia, emotional lability
Maltese: Dipressjoni, insomnija, ansjetà, burdati emozzjonali,
English: Table 4 Adverse reactions reported during clinical trials or following the marketing use of Ribavirin with pegylated interferon alfa-2b or interferon alfa-2b System Organ Class
Maltese: Tabella 4 Reazzjonijiet avversi rapportati b'Ribavirin ma' interferon alfa-2b pergilat jew interferon alfa-2b waqt provi kliniċi jew wara t-tqegħid fis-suq Klassifika tas-Sistema tal-Organi
English: Ribavirin BioPartners stops the multiplication of many types of viruses, including hepatitis C virus.
Maltese: Ribavirin BioPartners iwaqqaf ilmultiplikazzjoni ta' ħafna tipi ta' vajrusis, inkluż il-vajrus ta' l-epatite Ċ.
English: * Since ribavirin is always 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 non-pegylated).
Maltese: * Peress li ribavirin jiġi 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 pegilat)
English: Haematological abnormalities in HCV/HIV co-infected patients:
Maltese: Abnormalitajiet ematoloġiċi f'pazjenti infettati fl-istess ħin b'HCV/HIV:
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received ribavirin 15 mg/kg per day plus interferon alfa-2b 3 MIU/m2 3 times a week for 1 year followed by 6 months follow-up after treatment.
Maltese: Tfal u adolexxenti minn 3 sa' 16-il sena b'epatite Ċ kronika kkompensata u HCV-RNA li jista' jitkejjel (evalwat minn laboratorju ċentrali bl-użu ta' assaġġ RT-PCR ibbażat fuq ir-riċerka) kienu mdaħħla f'żewġ provi multiċentriċi u kkurati b'ribavarin 15 mg/kg kuljum ma' interferon alfa-2b 3 MIU/m2 3 darbiet fil-ġimgħa għal sena segwita minn 6 xhur ta' kura follow-up.
English: or
Maltese: ISEM
English: Twenty (21 %) of 97 children had a > 15 percentile decrease in height percentile, of whom 10 of the 20 children had a > 30 percentile decrease in their height percentile from the start of treatment to the end of long-term follow-up (up to 5 years).
Maltese: Għoxrin (21 %) tas-97 tifel u tifla kellhom > 15 fil-mija tnaqqis fil-perċentwali tat-tul tagħhom, li minnhom 10 mill-20 tifel u tifla kellhom tnaqqis ta' > 30 fil-mija tnaqqis fil-perċentwali tat-tul tagħhom minn meta nbdiet il-kura sa' tmiem is-sorveljanza fit-tul (sa' 5 snin).
English: In combination with interferon alfa-2b
Maltese: Flimkien ma' interferon alfa-2b
English: The MAH must ensure that the system of pharmacovigilance, as described in version 5 dated 27 April 2009 presented in Module 1.8.2 of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jiżgura li s-sistema ta' farmakoviġilanza, kif deskritta fil-verżjoni 5 iddatata 27 t'April 2009 inkluża f'Modulu 1.8.2 tal-applikazzjoni għallawtorizzazzjoni għat-tqegħid fis-suq Applikazzjoni tkun fis-seħħ u tiffunzjona qabel u waqt li l
English: - Lactation.
Maltese: − Treddigħ
English: Fungal infection, bacterial infection, pulmonary infection, nasopharyngitis, pharyngitis streptococcal, otitis media, sinusitis, tooth abscess, influenza, oral herpes, herpes simplex, urinary tract infection, vaginitis, gastroenteritis Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis Neoplasms benign, malignant and unspecified (including cysts and polyps)
Maltese: Infezzjoni tal-fungu, infezzjoni batterika, infezzjoni pulmonari, nażofarinġite, farinġite bi streptokokki, otitis media, sinusite, tnawwir ta' snien, influwenza, herpes filħalq, herpes simplex, infezzjoni tal-passaġġ awrinarju, vaginite, gastroenterite
English: Due to the lack of data in these two multicentre trials for children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).The study
Maltese: Minħabba nuqqas ta' dejta f'dawn iż-żewġ provi multiċentriċi fi tfal bi progressjoni severa tal-marda, u l-potenzjal ta' effetti mhux mixtieqa, il-benefiċċju/riskju tal-kombinazzjoni ta' ribavarin u interferon alfa-2b għandu jitqies b'attenzjoni f'din il-popolazzjoni (ara sezzjonijiet 4.1, 4.4 u 4.8).
English: • Ribavirin (1,000/1,200 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) (n = 514).
Maltese: • Ribavirin (1,000/1,200 mg/jum) + peginterferon alfa-2b (1.5 mikrogrammi/kg/ġimgħa għal xahar segwita b'0.5 mikrogrammi/kg/ġimgħa għal 11-il xahar) (n = 514).
English: Based on interim data from the long-term follow-up portion of this study, 22 % (16/74) of children had a > 15 percentile decrease in height percentile, of whom 3 (4 %) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Maltese: Minn dejta interim mill-parti followup fuq żmien twil ta' dan l-istudju, 22 % (16/74) tat-tfal kellhom > 15 perċentwali tnaqqis filperċentwali tat-tul, li minnhom 3-itfal (4 %) kellhom > 30 perċentwali tnaqqis minkejja li kienu ilhom aktar minn sena mingħajr kura.
English: Table 7 Sustained virological response based on genotype after ribavirin in combination with peginterferon alfa-2b in HCV/HIV co-infected patients
Maltese: Tabella 7 Rispons viroloġiku sostnut skont il-ġenotip wara ribavirin ingata flimkien ma' peginterferon alfa-2b f'pazjenti infettati fl-istess ħin b'HCV/HIV Studju 22
English: Haemolysis: A decrease in haemoglobin levels to < 10 g/dl was observed in up to 14 % of adult patients and 7 % of children and adolescents treated with ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials.
Maltese: Tnaqqis fil-livelli ta' emoglobina għal < 10 g/dl kien osservat f'sa 14 % ta' pazjenti adulti u 7 % ta' tfal u adoloxxenti ttrattati b'ribavirin flimkien ma' peginterferon alfa-2b jew interferon alfa-2b fi provi kliniċi.
English: This should be discussed with your doctor (see section “Do not take Ribavirin BioPartners”).
Maltese: Dan għandek tiddiskutih mat-tabib tiegħek (ara sezzjoni “Tieħux Ribavirin BioPartners”).
English: Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa-2b/ribavirin treatment.
Maltese: Kawtela għandha tittieħed f'individwi li rriżultaw pożittivi għal HIV u li huma ko-infettati b'HCV li qed jirċievu trattament bl-impedituri ta' nucleoside reverse transcriptase (NRTI) (l-aktar ddI u d4T) u t-trattament assoċjat b'interferon alfa-2b/ribavirin.
English: Ribavirin BioPartners is available in different pack sizes containing 84, 112, 140 or 168 film-coated tablets.
Maltese: Id-dehra ta' Ribavirin BioPartners u l-kontenuti tal-pakkett Ribavirin BioPartners hija pillola bajda, tonda, miksija b'rita, li ġejja fit-tond fin-naħa ta' fuq u Ribavirin BioPartners jiġi f'daqsijiet ta' pakketti differenti ta' 84, 112, 140 jew 168 pillola miksija Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għall-skop kummerċjali.
English: Severe adverse reactions were reported in 7 % (8/107) of all subjects and included injection site pain (1 %), pain in extremity (1 %), headache (1 %), neutropenia (1 %), and pyrexia (4 %).
Maltese: Reazzjonijiet avversi severi kienu rrappurtati f'7 % (8/107) ta' lindividwi kollha u kienu jinkludu uġigħ fis-sit ta' l-injezzjoni (1 %), uġigħ fl-estermitajiet (1 %), uġigħ ta' ras (1 %), newtropenija (1 %) u temperatura għolja (4 %).
English: Twelve out of 492 sustained responders and only 3 out of 366 sustained responders relapsed, respectively, in the studies.
Maltese: Mill-anqas 5 snin ta' follow-up fit-tul intemm wara kura fuq 462 pazjent u 327 pazjent, rispettivament.
English: One film-coated tablet contains 200 mg ribavirin.
Maltese: Pillola miksija b'rita fiha 200 mg ta' ribavirin.
English: Potential to exacerbate immunosuppression: Pancytopenia and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the administration of a peginterferon and ribavirin concomitantly with azathioprine.
Maltese: Fil-letteratura, panċitopenija u soppressjoni tal-mudullun kienu rrapportati li jseħħu fi żmien 3 sa 7 ġimgħat wara l-għoti ta' peginterferon u ribavirin flimkien ma' azathioprine.
English: Hypothyroidism, hyperthyroidism
Maltese: Ipertrigliċeridemija, iperurikemija
English: Note 1: In adult patients, 1st dose reduction of Ribavirin BioPartners is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day).
Maltese: Nota 1: F'pazjenti adulti l-ewwel tnaqqis tad-doża ta' Ribavirin BioPartners tkun ta' 200 mg/jum (ħlief li f'pazjenti li jkunu qed jirċievu l-1,400 mg, it-tnaqqis tad-doża għandu jkun b'400 mg/jum).
English: Rhabdomyolysis*, myositis*
Maltese: Dijabete mellitus, ipertrigliċeridemja*
English: Respiratory, thoracic and mediastinal disorders Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhoea, sneezing, pharyngolaryngeal
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Dispnea, takipnea, epistassi, sogħla, konġestjoni nasali, irritazzjoni nasali, rajnorreja, għatis, uġigħ fil-farinġi u
English: In combination with peginterferon alfa-2b
Maltese: Ribavarin flimkien ma' peginterferon alfa-2b
English: Ribavirin BioPartners film-coated tablets in combination with interferon alfa-2b:
Maltese: Pilloli miksija b'rita Ribavirin BioPartners f'kombinazzjoni ta' interferon alfa-2b:
English: Ribavirin in combination with interferon alfa-2b
Maltese: Ribavirin f'taħlita ma' interferon alfa-2b
English: Sarcoidosis*, rheumatoid arthritis (new or aggravated) Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction,
Maltese: Sindromu Vogt-Koyanagi-Harada, lupus eritematosi sistemiku, vaskulite, reazzjonijiet ta' sensittività eċċessiva li jinkludu urikarja, anġjodema, tidjieq
English: In children and adolescent patients treated with Ribavirin BioPartners plus interferon alfa-2b, reduce ribavirin dose to 7.5 mg/kg/day.
Maltese: F'pazjenti tfal u adolexxenti ikkurati b'Ribavirin BioPartners ma' interferon alfa-2b, naqqas id-doża ta' Ribavirin BioPartners għal 7.5 mg/kg/jum.
English: Renal function: Single-dose ribavirin pharmacokinetics were altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 ml/minute).
Maltese: Il-farmakokinetiċi ta' doża waħda ta' ribavirin kienu mibdula (żieda fl-AUCtf u Cmax) fpazjenti li l-kliewi tagħhom ma kinux qed jaħdmu sew meta mqabbla ma' individwi bħala kontrolli (tneħħija ta' kreatinina > 90 ml/minuta).
English: Retinal haemorrhages*, retinopathies (including macular oedema)*, retinal artery occlusion*, retinal vein occlusion*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, retinal exudates
Maltese: Emorraġiji retinali*, retinopatiji (li jinkludu edema makulari)*, sadda tal-arterja retinali*, sadda talvina retinali*, newrite ottika*, papilloedema*, tnaqis flakuwita viżwali jew fil-kamp viżwali*, tnixxijiet mir-retina Disturbi fil-widnejn u fis-sistema labirintika Vertiġini, smigħ jiħżien/jintilef, tinnite, uġigħ fil-widnejn Palpitazzjoni, takikardja
English: Approximately 12 to 21 % of children treated with ribavirin and interferon alfa-2b (pegylated and nonpegylated) developed increase in thyroid stimulating hormone (TSH).
Maltese: Madwar 12 sa 21 % tat-tfal trattati b'ribavirin u interferon alfa-2b (pegilat u mhux pegilat) żviluppaw żieda fl-ormon li jistimula t-tirojde (TSH).
English: WHAT RIBAVIRIN BIOPARTNERS IS AND WHAT IT IS USED FOR Ribavirin BioPartners contains the active ingredient ribavirin.
Maltese: X'INHU RIBAVIRIN BIOPARTNERS U GĦALXHIEX JINTUŻA Ribavirin BioPartners fih is-sustanza attiva ribavirin.
English: - severe rashes which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes (erythema multiforme, Stevens Johnson syndrome), toxic epidermal necrolysis (blistering and peeling of the top layer of skin).
Maltese: - raxx sever li jista' jkun assoċjat ma' nfafet fil-ħalq, fl-imnieħer, fl-għajnejn u membrani mukużi oħrajn (eritema multiforme, is-sindrome ta' Stevens Johnson), nekrolisi tossika epidermali (infafet u tqaxxir fis-saff ta' fuq tal-ġilda).
English: Ribavirin BioPartners in combination with peginterferon alfa-2b or interferon alfa-2b may also cause: - dark, cloudy or abnormally coloured urine, - difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw
Maltese: Ribavirin Biopartners flimkien ma' peginterferon alfa-2b jew interferon alfa-2b jista' jikkawża wkoll: - awrina skura, imħallba jew b'kulur anormali, - diffikultà biex tieħu n-nifs, bidliet fil-mod kif tħabbat qalbek, uġigħ fi-sider, uġigħ fin-naħa t'isfel ta' dirgħajk, uġigħ fix-xedaq,
English: Renal failure, renal insufficiency*
Maltese: Indebiliment renali, insuffiċjenza tal-kliewi*
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during ribavirin combination therapy with peginterferon alfa-2b or interferon alfa-2b, and even after treatment discontinuation mainly during the 6-month follow-up period.
Maltese: Effetti severi tas-SNĊ, b'mod partikolari dipressjoni, ħsibijiet suwiċidali jew tentattivi ta' suwiċidju dehru f'xi pazjenti waqt l-użu b'terapija kombinata b'ribavirin ma' interferon alfa-2b, u anki wara li t-trattament twaqqaf u prinċipalment fis-sitt xhur ta' wara.
English: During the course of interferon (standard and pegylated)/ribavirin therapy lasting up to 48 weeks in patients ages 3 through 17 years, weight loss and growth inhibition were common (see sections 4.8 and 5.1).
Maltese: Waqt il-kors ta' terapija kombinata b'interferon (standard u pegilat)/ribavirin li dam sa' 48 ġimgħa f'pazjenti ta' etajiet minn 3 sa' 17-il sena, telf tal-piż u inibizzjoni tat-tkabbir kienu komuni (ara sezzjonijiet 4.8 u 5.1).
English: During combination therapy for up to 48 weeks with interferon alfa-2b and ribavirin, growth inhibition is observed, the reversibility of which is uncertain.
Maltese: Waqt terapija kombinata li damet sa' 48 ġimgħa b'interferon alfa-2b u ribavirin, inibizzjoni tat-tkabbir dehret, li mhux magħruf jekk hijiex riversibbli.
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-tirojdi waqt it-trattament b'ribavirin u interferon alfa-2b u waqt il-kura b'ribavirin and peginterferon alfa-2b kienet innutata.
English: Ribavirin BioPartners is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b.
Maltese: Ribavirin BioPartners huwa indikat għal trattament ta' infezzjoni b'virus (HCV) ta' epatite Ċ kronika fl-adulti, fi tfal minn 3 snin 'l fuq u adolexxenti u għandu jkun użat biss bħala parti minn programm ta' terapija li jingħata flimkien ma' interferon alfa-2b.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each Ribavirin BioPartners film-coated tablet contains 200 mg of ribavirin.
Maltese: Kull pillola miksija b'rita Ribavirin BioPartners fiha 200 mg ta' ribavirin.
English: Ocular changes: Ribavirin is used in combination therapy with alpha interferons.
Maltese: Ribavirin jintuża fi trattament flimkien ma' alfa interferons.
English: Among children and adolescents, treated with ribavirin in combination with interferon alfa-2b, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % versus 1 %) during treatment and during the 6-month follow-up after treatment.
Maltese: Barra minn hekk, ħsibijiet jew tentattivi ta' suwiċidju kienu rapportati b'mod aktar ta' spiss meta mqabbla mal-popolazzjoni adulta (2.4 % vs 1 %) waqt it-trattament u fis-6 xhur wara t-trattament.
English: Ribavirin (800-1,200 mg /day)d + peginterferon alfa-2b (100 or 150c μg/week)
Maltese: Ribavarin (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
English: Antacid: The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14 %.
Maltese: Il-bijodisponibilità ta' ribavirin 600 mg kienet imnaqqsa meta ngħata flimkien ma' antaċidu li kien fih manjesju aluminju u simethicone; AUCtf tnaqqas b'14 %.