FrancophonIA/ELRC3.0 huggingface dataset:
English: Packs of 84, 112, 140 and 168 capsules Not all pack sizes may be marketed.
Maltese: Pakketti f'daqsijiet ta' 84, 112, 140 u 168 kapsula Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: The pharmacokinetics of ribavirin and interferon alfa-2b (dose-normalized) is similar in adults and children or adolescents.
Maltese: Ilfarmakokinetika ta' ribavirin u interferon alfa-2b (doża normalizzata) hija simili fl-adulti jew adoloxxenti.
English: Anaemia (haemoglobin < 9.4 g/dL) was reported in 12 % (23/194) of patients treated with ribavirin in combination with peginterferon alfa-2b.
Maltese: Anemija (emoglobina < 9.4 g/dL) kienet irrappurtata fi 12 % (23/194) tal-pazjenti trattati b'ribavirin f'kombinazzjoni ma' peginterferon alfa-2b.
English: Volume of distribution is approximately 5,000 l. Ribavirin does not bind to plasma proteins.
Maltese: Il-volum ta' distribuzzjoni huwa ta' madwar 5,000 l. Ribavirin ma jintrabatx malproteini tal-plażma.
English: Capsule shell Titanium dioxide (E171) Gelatin
Maltese: Il-qoxra tal-kapsula Titanium dioxide (E171) Gelatin
English: 4 capsulesb Refer to adult dose recommendation a: 1 morning, 2 evening b: 2 morning, 2 evening
Maltese: 4 kapsulib Irreferi għar-rakkomandazzjonijiet tad-doża fl-adulti a: 1 filgħodu, 2 filgħaxija b: 2 filgħodu, 2 filgħaxija
English: Ribavirin was active in the Balb/3T3 in vitro transformation assay.
Maltese: Ribavirin kien attiv fl-assaġġ tattrasformazzjoni tal-Balb/3T3 in vitro.
English: Male: impotence, prostatitis, erectile dysfunction, Sexual dysfunction (not specified)*
Maltese: Rġiel: impotenza, prostatite, ma jkunx hemm twebbis, Nuqqas ta' funzjoni sesswali (mhux speċifikata)*
English: Tmax (hr) Cmax (ng/mL) AUC* Apparent clearance L/hr/kg
Maltese: Tmax (hr) Cmax (ng/mL)
English: For HCV/HIV co-infected patients receiving ribavirin in combination with peginterferon alfa-2b, other adverse reactions (that were not reported in mono-infected patients) which have been reported in the studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Maltese: Għal pazjenti infettati fl-istess ħin b'HCV/HIV li qed jirċievu ribavirin f'kombinazzjoni ma' peginterferon alfa-2b, reazzjonijiet avversi oħra (li ma kienux irrappurtati f'pazjenti b'infezzjoni waħda) li kienu rrappurtati fl-istudji bi frekwenza > 5 % kienu: kandidijażi orali (14 %), lipodistrofija akkwiżita (13 %), tnaqqis fil-linfoċiti CD4 (8 %), tnaqqis fl-aptit (8 %), żieda fil-gammaglutamyltransferase i (9 %), uġigħ fid-dahar (5 %), żieda tal-amylase fid-demm (6 %), żieda fl-aċidu lattiku fid-demm (5 %), epatite ċitolitika (6 %), żieda fil-lipase (6 %) u uġigħ fir-riġel/driegħ (6 %).
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors, ATC code: J05AB04.
Maltese: Kategorija farmakoterapewtika: antivirali għall-użu sistematiku, nukleosidi u nukleotidi minbarraimpedituri reverse transcriptase, Kodiċi ATC:
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)*, okklużjoni tal-arterja retinali*, okklużjoni talvina retinali*, newrite ottika*, papilloedema*, tnaqis flakuwita viżwali jew fil-kamp viżwali*, tnixxija retinali*
English: Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Maltese: Ribavirin huwa assorbit malajr wara li jingħata mill-ħalq b'doża waħda (il-medja Tmax= 1.5 sigħat), segwit minn distribuzzjoni mgħaġġla u fażijiet ta' eliminazzjoni mtawwla (half-lives ta' assorbiment b'dożi waħidhom, distribuzzjoni u eliminazzjoni huma 0.05, 3.73 u 79 siegħa, rispettivament).
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week peginterferon alfa-2b and subjects ≥ 75 kg received 150 µg/week peginterferon alfa-2b .
Maltese: b: valur p ibbażat fuq it-test chi-square. c: individwi < 75 kg ħadu 100 µg/ġimgħa peginterferon alfa-2b u individwi ≥ 75 kg irċevew
English: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Maltese: Barra minn hekk, 98 % (51/52) b'livelli normali ta' ALT filġimgħa 24 ta' follow-up żammew livelli normali ta' manteniment ta' ALT fl-aħħar viżta tagħhom.
English: A reduction in haemoglobin concentrations by > 4 g/dL was observed in 30 % of patients treated with ribavirin and peginterferon alfa-2b and 37 % of patients treated with ribavirin and interferon alfa-2b.
Maltese: Tnaqqis fil-konċentrazzjoni ta' emoglobulina b' > 4 g/dL kien osservat fi 30 % tal-pazjenti trattati b' ribavirin u peginterferon alfa-2b u 37 % tal-pazjenti trattati b'ribavirin u interferon alfa-2b.
English: In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
Maltese: Fil-prova klinika C/I98-580, 1530 pazjent inkonsapevoli kienu trattati għal sena b'wieħed millprogrammi ta' kombinazzjoni li ġejjin
English: Other medicines and Ribavirin Teva
Maltese: Mediċini oħra u Ribavirin Teva
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
Maltese: Fil-klassifika tas-sistema tal-organi, ir-reazzjonijiet avversi huma elenkati taħt titli ta' frekwenzi bil-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħuf.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton 84, 112, 140, 168 hard capsules
Maltese: Kartuna ta' Barra ta' 84, 112, 140, 168 kapsula iebsa
English: Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Maltese: Attività ġenotossika kienet osservata fl-assaġġ tal-limfoma talġrieden, u b'dożi ta' 20-200 mg/kg f'assaġġ tal-mikronukleju tal-ġrieden.
English: Ribavirin must not be used by females who are pregnant (see sections 4.3, 4.4 and 5.3).
Maltese: Ribavirin m'għandux jintuża minn nisa waqt it-tqala (ara sezzjonijiet 4.3, 4.4 u 5.3).
English: Ribavirin Teva 200 mg hard capsules
Maltese: Ribavirin Teva 200 mg kapsuli iebsin
English: Ribavirin Teva is a white, opaque, hard capsule imprinted with blue ink.
Maltese: Ribavirin Teva hija kapsula iebsa bajda, opaka immarkata b'linka blu.
English: Usual daily Ribavirin Teva dose Number of 200 mg capsules 600 mg
Maltese: Doża ta' kuljum ta' ribavirin Numru ta' kapsuli ta' 200 mg 600 mg
English: Ribavirin Teva 200 mg hard capsules ribavirin
Maltese: Ribavirin Teva 200 mg kapsuli iebsin ribavirin
English: There is a linear relationship between dose and AUCtf following single doses of 200-1,200 mg ribavirin.
Maltese: Hemm relazzjoni lineari bejn id-doża u l-AUCtf wara dożi waħedhom ta' 2001,200 mg ribavirin.
English: For children and adolescents weighing less than 47 kg a solution formulation is available.
Maltese: Għal tfal u adoloxxenti li jiżnu inqas minn 47 kg hemm soluzzjoni hija disponibbli.
English: (see section “Pregnancy and breast-feeding”)
Maltese: (ara s-sezzjoni “Tqala u treddigħ”)
English: Ribavirin Teva is available in different pack sizes containing 84, 112, 140 or 168 capsules to be swallowed.
Maltese: Ribavirin Teva jiġi f'daqsijiet ta' pakketti differenti ta' 84, 112, 140 jew 168 kapsula li għandhom jinbelgħu.
English: Elderly (≥ 65 years of age)
Maltese: Persuni akbar fl-età (≥ 65 sena)
English: Ribavirin (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg)
Maltese: Ribavirin (1,000/1,200 mg) + peginterferon alfa-2b (1.5 sa 0.5 mikrogrammi/kg)
English: Ribavirin (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg)
Maltese: Ribavirin (800 mg) + peginterferon alfa-2b (1.5 mikrogrammi/kg)
English: No pharmacokinetic interactions were noted between ribavirin and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
Maltese: L-ebda interazzjonijiet farmakokinetiċi ma kienu nnotati bejn ribavirin u peginterferon alfa-2b jew interferon alfa-2b fi studju farmakokinetiku b'dożi multipli.
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);
Maltese: Fi ħdan il-kategorija tas-sistema tal-organi, reazzjonijiet avversi huma elenkati taħt titli ta' frekwenza permezz tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10), u mhux komuni (≥ 1/1,000 sa < 1/100).
English: Table 8 Sustained virological response based on genotype after ribavirin in combination with peginterferon alfa-2b in HCV/HIV co-infected patients
Maltese: Tabella 8 Rispons viroloġiku sostnut skont il-ġenotip wara ribavirin ingata flimkien ma' peginterferon alfa-2b f'pazjenti koinfettati b'HCV/HIV
English: Each Ribavirin Teva capsule contains 200 mg of ribavirin For the full list of excipients, see section 6.1.
Maltese: Kull kapsula ta' Ribavirin Teva fiha 200 mg ta' ribavirin Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Renal failure, renal insufficiency*
Maltese: Indeboliment renali, insuffiċjenza tal-kliewi*
English: In general, the adverse event profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition, as decrease in height percentile (mean percentile decrease of growth velocity of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Maltese: B'mod ġenerali, il-profil ta' effetti avversi fil-popolazzjoni limitata ta' tfal u adoloxxenti li kienet studjata kien simili għal dak osservat fl-adulti, għalkemm l-impediment ta' żvilupp huwa ta' tħassib speċifiku għall-popolazzjoni pedjatrika, peress li tnaqqis perċentili fit-tul (tnaqqis perċentwali medju tar-rata tat-tkabbir ta' 9 perċentili) u fil-perċentil tal-piż (tnaqqis perċentili medju ta' 13-il perċentil ) kienu osservati waqt it-trattament.
English: This decline was significant among responders (0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among nonresponders.
Maltese: Dan it-tnaqqis kien sinifikanti fost dawk li wrew rispons (-0.3 għal Metavir u -1.2 għal Ishak) u stabbli (-0.1 għal Metavir u -0.2 for Ishak) fost dawk li ma kellhomx rispons.
English: For patients receiving a 800 mg (< 65 kg) - 1,000 mg (65-80 kg) - 1,200 mg (81-105 kg) or 1,400 mg (> 105 kg) dose, 1st dose reduction of Ribavirin Teva is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day).
Maltese: Għal pazjenti li jkunu qed jirċievu doża ta' 800 mg (< 65 kg)-1,000 mg (65-80 kg)-1,200 mg (81-105 kg) jew 1,400 mg (> 105 kg), l-1el tnaqqis fid-doża ta' Ribavirin Teva jkun ta' 200 mg/jum
English: The capsule shell imprint contains shellac, titanium dioxide (E171) and indigo carmine
Maltese: L-intaljar fuq il-qoxra ta' barra jikkonsisti minn shellac, titanium dioxide (E171) u indigo carmine
English: Adult patients: Ribavirin Teva 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 Teva huwa indikat għall-użu, flimkien ma' interferon alfa-2b, għal trattament f'pazjenti adulti b'kull tip 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 ta' epatite Ċ, HCV-RNA (ara sezzjoni 4.4).
English: Ribavirin (8001,200 mg/day) d + interferon alfa-2b (3 MIU TIW)
Maltese: Ribavirin (8001,200 mg/jum) d + interferon alfa-2b (3 MIU TIW)
English: This medicine stops the multiplication of many types of viruses, including hepatitis C virus.
Maltese: Din il-mediċina twaqqaf il-multiplikazzjoni ta' ħafna tipi ta' virusis, li jinkludu l-virus ta' epatite Ċ.
English: Girl or woman of childbearing age:
Maltese: • Xebba jew mara ta' età li jista' jkollha t-tfal:
English: 4 % (8/194) of patients receiving ribavirin in combination with peginterferon alfa-2b.
Maltese: deher f'4 % (8/194) tal-pazjenti li kienu jiċievu ribavirin f'kombinazzjoni ma' peginterferon alfa-2b.
English: p valueb
Maltese: Value pa
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 (8001,200 mg/day based on weight) plus interferon alfa-2b (3 MIU TIW).
Maltese: Il-pazjenti ntgħażlu b'mod każwali biex jew jirċievu ribavirin (800-1,200 mg/jum skont il-piż) flimkien ma' peginterferon alfa-2b (100 jew 150 µg/ġimgħa skont ilpiż) jew ribavirin (8001,200 mg/jum skont il-piż) flimkien ma' interferon alfa-2b (3 MIU TIW).
English: Please refer to the corresponding SmPC of medicinal products used in combination with Ribavirin Teva .
Maltese: Jekk jogħġbok irreferi għall-SmPC korrispondenti tal-prodotti mediċinali użati flimkien ma' Ribavirin Teva.
English: Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “Laboratory tests” and section 4.8).
Maltese: Għalkemm, il-biċċa l-kbira tagħhom jistgħu jkunu ġestiti bi tnaqqis fid-doża, monitoraġġ mill-qrib ta' parametri ematoloġiċi għandu jsir f'din il-popolazzjoni ta' pazjenti (ara sezzjoni 4.2 u hawn isfel “Testijiet tallaboratorju” u sezzjoni 4.8).
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of ribavirin is available.
Maltese: Għal tfal u adoloxxenti li ma jistgħux jibilgħu kapsula iebsa, soluzzjoni orali ta' ribavirin hi disponibbli.
English: 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: Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of ribavirin.
Maltese: Ir-riżultati minn studji in vitro li fihom intużaw preparazzjonijiet ta' mikrożomi tal-fwied kemm talbniedem kif ukoll tal-firien ma indikaw l-ebda metaboliżmu ta' ribavirin medjat mill-enżima ta' cytochrome P450.
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 wieħed segwiti minn 0.5 mikrogrammi/kg/ġimgħa għal 11-il xahar) (n = 514).
English: Contents of the pack and other information What Ribavirin Teva contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Ribavirin Teva
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: Żewġ studji li eżaminaw l-użu kkombinat ta' ribavirin u interferon alfa-2b f'pazjenti li jirkadu (C95144 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: Neuropathy, peripheral neuropathy
Maltese: Newtropatija, newropatija periferika
English: Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Maltese: Emorraġija ċerebrovaskulari*, iskemija ċerebrovaskulari*,
English: Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and ribavirin when administered to paediatric patients with chronic hepatitis C
Maltese: Medja (% CV) ta' parametri farmakokinetiċi b'ħafna dożi għal for interferon alfa-2b u kapsuli Ribavirin meta jingħataw lil pazjenti pedjatriċi b'epatite Ċ kronika
English: This medicine in combination with an alpha interferon product may also cause:
Maltese: Din il-mediċina flimkien ma' prodott ta' alpha interferon tista' tikkawża:
English: − vasculitis.
Maltese: - Treddigħ.
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 ngħataw b'mod każwali jew ribavirin (800 mg/jum) flimkien ma' peginterferon alfa-2b (1.5 µg/kg/ġimgħa) jew Ribavirin (800 mg/jum) flimkien ma' interferon alfa-2b (3 MIU TIW) għal 48 ġimgħa b'perijodu ta' follow-up għal 6 xhur.
English: Each capsule contains 200mg of ribavirin
Maltese: Kull kapsula fiha 200 mg of ribavirin
English: Ribavirin, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-methylthioinosine monophosphate (6-MTIMP), which has been associated with myelotoxicity in patients treated with azathioprine.
Maltese: Ribavirin, minħabba li jista' jkollu effett inibitorju fuq inosine monophosphate dehydrogenase, jista' jinterferixxi mal-metaboliżmu ta' azathioprine billi possibilment iwassal għal akkumulazzjoni ta' 6methyl monophosphate (6-MTIMP), li hu assoċjat ma' mijelotossiċità f'pazjenti ikkurati b'azathioprine.L-użu ta' pegylated alpha interferons u ribavirin flimkien ma' azathioprine għandu jiġi evitat.
English: The capsule shell contains titanium dioxide (E171) and gelatin.
Maltese: Il-qoxra tal-kapsula fiha titanium dioxide (E171) u gelatin.
English: Upon multiple dosing, ribavirin accumulates extensively in plasma with a six-fold ratio of multipledose to single-dose AUC12hr.
Maltese: Wara dożaġġ multiplu, ribavirin jakkumula b'mod estensiv fil-plażma bi proporzjon ta' sitt darbiet 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 batterika (li tinkludi sepsis), infezzjoni tal-fungu, influwenza, infezzjoni fl-apparat respiratorju, brokite, herpes simplex, sinusite, otitis media, rinite, infezzjoni fil-passaġġ awrinarju
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/m times a week for 1 year followed by 6 months follow-up after treatment.
Maltese: Tfal u adoloxxenti minn 3 sa 16-il sena b'epatite Ċ kronika kumpensata u HCV-RNA li setgħu jitkejlu (imkejjel minn laboratorju ċentrali bl-użu ta' assaġġ permezz tal-RT-PCR li jintuża għar-riċerka) kienu arwolati f'żewġ provi multiċentrali u rċevew ribavirin 15 mg/kg kuljum flimkien ma' interferon alfa-2b 3 MIU/m
English: HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and cART maybe at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia andanaemia) compared to HCV mono-infected patients.
Maltese: Pazjenti li fl-istess ħin ikunu infettati b'HCV/HIV li jkunu qed jirċievu trattament b'peginterferon alfa-2b/ribavirin u cART jistgħu jkunu f'riskju akbar li jiżviluppaw anormalitajiet ematoloġiċi (bħala neutropenja, tromboċitopenja u anemija) meta mqabbla ma' pazjenti infettati b'HCV biss.
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin Teva 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 Teva għandu jitwaqqaf minnufih u tinbeda terapija medika xierqa.
English: Suicidal ideation, psychosis, aggressive behaviour, confusion, agitation, anger, mood altered, abnormal behaviour, nervousness, sleep disorder, decreased libido apathy, abnormal dreams, crying
Maltese: Ħsibijiet suwiċidali, psikosi, mġieba aggressiva, konfużjoni, aġitazzjoni, rabja, tibdil fil-burdata, mġieba mhux normali, nervożità, disturbi fl-irqad, tnaqqis fil-ħajra sesswali, apatija, ħolm mhux normali, biki
English: Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhoea, sneezing, pharyngolaryngeal pain
Maltese: Dispnea, takipnea, epistassi, sogħla, konġestjoni nasali,
English: Ninety four of 107 children enrolled in the 5 year long-term follow up trial.
Maltese: Erbgħa u disgħin minn 107 itfal kienu rreġistrati fil-prova ta' segwitu fit-tul ta' 5 snin.
English: Multiple-dose pharmacokinetic properties for ribavirin capsules and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 10.
Maltese: Il-karatteristiċi tal-farmakokinetiċi b'ħafna dożi għal kapsuli ribavirin u interferon alfa-2b fi tfal u adoloxxenti b'epatite Ċ kronika ta' età bejn 5 u 16-il sena qed jintwerew fil-qosor f'Tabella 10.
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
Maltese: Tabella 6 Reazzjonijiet avversi komuni rapportati b'mod komuni, komuni u mhux komuni waqt ilprovi kliniċi fi tfal u adoloxxenti b'ribavirin ma' ribavirin f'kombinazzjoni ma' interferon alfa-2b jew peginterferon alfa-2b
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm was observed in
Maltese: Fi Studju 1 (ara sezzjoni 5.1), tnaqqis fl-għadd assolut tan-newtrofili taħt il-500 ċellula/mm33deher f'4 % (8/194) tal-pazjenti u tnaqqis fl-għadd talplejtlets għal taħt 50,000/mm33
English: HCV/HIV Co-infection
Maltese: Pazjenti koinfettati b'HCV/HIV
English: Standard haematologic tests,blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) and pregnancy tests must be conducted in all patients prior to initiating therapy.
Maltese: Qabel ma tinbeda t-terapija il-pazjenti kollha għandhom isirulhom t-testijiet ematoloġiċi standard, testijiet tal-kimika tad-demm (għadd sħiħ u divrenzjali ta' ċelluli tad-demm [CBC - complete blood count], l-għadd ta' plejtlits, elettroliti, kreatinin fis-serum, testijiet tal-funzjoni tal-fwied, l-aċidu uriku) u testijiet tat-tqala.