FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 9 Virologic response at treatment week 12, end of treatment response, relapse rate* and Sustained Virologic Response (SVR)
Maltese: Tabella 9 Rispons viroloġiku sostnut ma' ġimgħa 12, rispons ma' tmiem il-kura, rata li rkadew* u Rispons Viroloġiku Sostnut (SVR)
English: Blisters: Cardboard box containing 56 or 168 hard capsules in PVC/Aclar - Aluminium foil blisters
Maltese: Kaxxa tal-kartun li fiha 56 jew 168 kapsuli ibsin f'PVC/Aclar - Folji magħmula minn fojl tal-aluminju
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 għar-riskju akbar ta' aċidożi lattika kkaġunata minn analogi tan-nuklejosajd tal-purina (eż. didanosine jew abacavir).
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 fil-pazjenti kollha għandhom isiru testijiet tad-demm kemm dawk standard kif ukoll kimiċi (għadd komplet tad-demm [CBC] u differenzjali, l-għadd tal-plejtlets, elettroliti, krejatinina fis-serum, testijiet tal-funzjoni tal-fwied, uric acid) u testijiet tat-tqala.
English: Neoplasm unspecified
Maltese: Neoplasmi mhux speċifikati
English: Dyspnoea, coughing
Maltese: Dispneja, sogħla
English: Patients co-infected with HCV/HIV: Patients taking NRTI treatment in association with ribavirin and interferon alfa-2b may be at increased risk of mitochondrial toxicity, lactic acidosis and hepatic decompensation (see section 4.4).
Maltese: Pazjenti li huma infettati wkoll bl-HCV/HIV: Pazjenti li jkunu qed jieħdu kura b'NRTI) flimkien ma' ribavirin u interferon alfa-2b, jistgħu jkunu f'riskju miżjud ta' tossiċità mitokondrijali, aċidożi lattika u dikumpensazzjoni tal-fwied (ara sezzjoni 4.4).
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: - Kura mill-ġdid ta' pazjenti li rkadew b'kura kkombinata ta' ribavirin ma' interferon alfa-2b Żewġ studji li eżaminaw l-użu tal-kura imħallta ta' ribavirin + interferon alfa-2b f'pazjenti li jirkadu (C95-144 u I95-145); 345 pazjent b'epatite kronika li kienu diġa' rkadew b'kura ta' interferon li ngħatat qabel, kienu kkurati għal sitt xhur, b'sitt xhur ta' follow-up.
English: • Ribavirin (800 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week) (n=511).
Maltese: Ribavirin (800 mg/jum) + peginterferon alfa-2b (1.5 mikrogrammi/kg/ġimgħa)
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' l-emoglobina għal < 10 g/dl kien osservat f'sa 14 % tal-pazjenti adulti u f'7 % ta' tfal u adolexxenti kkurati b'ribavirin flimkien ma' peginterferon alfa-2b jew interferon alfa-2b fi provi kliniċi.
English: All Genotypes Genotype 1 Genotype 2 Genotype 3c Genotype 4
Maltese: Ġenotipi kollha Ġenotip 1 Ġenotip 2 Ġenotip 3
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, iddefiċjenza ta' Lapp Lactase jew assorbiment ħażin ta' glucose/ galactose m'għandhomx jieħdu din ilmediċina.
English: Ribavirin in combination with peginterferon alfa-2b Children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCVRNA were enrolled in a multicentre trial and treated with ribavirin 15 mg/kg per day plus pegylated interferon alfa-2b 60 µg/m once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Maltese: Tfal u adolexxenti minn 3 sa' 17-il sena b'epatite Ċ kronika kkompensata u HCV-RNA li jista' jitkejjel kienu mdaħħla fi prova multiċentrika u kkurati b'ribavirin 15 mg/kg kuljum ma' interferon alfa-2b pegilat 60 μg/m fil-ġimgħa għal 24 jew 48 ġimgħa, skont il-ġenotip ta' l-HCV u l-viral load mal-linja bażi.
English: However, in a population pharmacokinetic study, age was not a key factor in the kinetics of ribavirin; renal function is the determining factor.
Maltese: Madankollu, fi studju farmakokinetiku dwar il-popolazzjoni, l-età ma kinetx fattur importanti fil-kinetika ta' ribavarine; ilfunzjoni renali hija l-fattur determinanti.
English: This should be discussed with your doctor (see section “Do not take Ribavirin Mylan”).
Maltese: Dan għandek tiddiskutih mat-tabib tiegħek (ara sezzjoni “Tiħux Ribavirin Mylan”).
English: Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
Maltese: Ilpazjenti għandhom ikunu monitorjati mill-qrib għal sinjali jew sintomi ta' mard psikjatriku.
English: In general, the adverse reaction 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 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment Within the 5 years follow-up post-treatment period, the children had a mean height of 44
Maltese: B'mod ġenerali, il-profil ta' reazzjonijiet avversi fil-popolazzjoni limitata tat-tfal u adolexxenti kien jixbah lill-dak ta' l-adulti, għalkemm hemm tħassib speċifiku għat-tfal dwar l-inibizzjoni tat-tkabbir bħal tnaqqis fil-perċentwali tat-tul (perċentwali medja ta' tnaqqis ta'9 fil-mija) u fil-perċentwali tal-piż (perċentwali medja ta' tnaqqis ta' 13 fil-mija) dehret waqt il-kura.
English: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two peginterferon alfa-2b/ ribavirin regimens [peginterferon alfa-2b 1.5 µg/kg and 1 µg/kg subcutaneously once weekly both in combination with ribavirin 800 to 1,400 mg p.o. daily (in two divided doses)] and peginterferon alfa-2a 180 µg subcutaneously once weekly with ribavirin 1,000 to 1,200 mg p.o. daily (in two divided doses) in 3,070 treatment-naïve adults with chronic hepatitis C genotype 1.
Maltese: Prova klinika kbira randomized qabblet is-sigurtà u l-effikaċja tal-kura għal 48 ġimgħa ma' żewġ korsijiet ta' peginteferon alfa-2b/ribavirin [peginterferon alfa-2b 1.5 µg/kg u 1 µg/kg minn taħt il-ġilda darba fil-ġimgħa kemm flimkien ma' ribavirin 800 sa' 1,400 mg f'pilloli kuljum (maqsuma f'żewġ dożi)] u peginterferon alfa-2a 180 µg minn taħt il-ġilda darba fil-ġimgħa ma' ribavirin 1,000 sa' 1,200 mg f'pilloli kuljum (maqsuma f'żewġ dożi) f'3,070 adult naïve għall-kura b'epatite Ċ kronika ta' ġenotip 1.
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-CNS, l-aktar dipressjoni, ħsibijiet ta' suwiċidju jew tentattivi ta' suwiċidju dehru f'xi pazjenti waqt l-użu b'terapija kombinata b'ribavirin ma' peginterferon alfa-2b jew interferon alfa-2b, u anki wara li titwaqqaf il-kura u fil-perijodu ta' 6-xhur ta' wara.
English: HCV-RNA negative or ≥ 2 log decrease in viral load
Maltese: HCV-RNA negattiv jew ≥ 2 log tnaqqis fil-viral load
English: HCV 2 ≤ 600,000 IU/ml > 600,000 IU/mL 100% (22/22) HCV 3 ≤ 600,000 IU/ml > 600,000 IU/ml
Maltese:  600,000 IU/ml > 600,000 IU/ml HCV 3
English: - Breast-feeding.
Maltese: Popolazzjoni pedjatrika
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: F'pazjenti li jkollhom fl-istess ħin HCV/HIV, dejta limitata dwar l-effikaċja u s-sigurtà (N=25) huma disponibbli f'individwi b'għadd tas-CD4 anqas minn 200 cellula/µl.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were coinfected with HIV.
Maltese: Studju 2 (P02080) kien randomized, f'ċentru wieħed li fih ħadu sehem 95 pazjent adult li ma kienux ikkurati qabel b'epatite C kronika li kellhom lHIV fl-istess ħin.
English: Discontinue Ribavirin Mylan if:
Maltese: Waqqaf Ribavirin Mylan jekk:
English: • Men:
Maltese: c:
English: Each capsule contains 200 mg ribavirin.
Maltese: Kull kapsula iebsa fiha 200 mg ta' ribavirin.
English: Ribavirin in combination with interferon alfa-2b:
Maltese: Ribavirin flimkien ma' interferon alfa-2b:
English: Bottles:
Maltese: Emolisi:
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 adolexxenti 3 sa 16-il sena b'epatite C kronika kumpensata u HCV-RNA li setgħu jitkejjlu (imkejjel minn laboratorju ċentrali bl-użu ta' assay RT-PCR li jintuża għar-riċerka) kienu reklutati f'żewġ provi multiċentriċi u rċevew ribavirin 15 mg/kg kull jum ma' interferon alfa-2b 3 MIU/m 3 darbiet fil-ġimgħa għal sena 1 segwit b'6 xhur follow-up wara l-kura.
English: Mylan AB Tel: +46 855 522 750
Maltese: Tel: +46 855 522 750
English: Ischaemic colitis
Maltese: Rispons Qabel Jirkadu
English: Paediatric population: Growth and development:
Maltese: Popolazzjoni pedjatrika:
English: If serum creatinine rises to > 2 mg/dl (Table 2) Ribavirin Mylan and interferon alfa-2b must be discontinued.
Maltese: Jekk il-krejatinina fis-serum titla' għal > 2 mg/dl (Tabella 3), Ribavirin Mylan u interferon alfa-2b għandhom jitwaqqfu.
English: Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see section 4.4).
Maltese: Rapporti ta' tossiċità mitokondrijali, l-aktar aċidożi lattika u pankrejatite, ftit minnhom fatali, kienu rrappurtati (ara sezzjoni 4.4).
English: Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorder, mania, confusion and alterations of mental status have been observed with alpha interferons.
Maltese: Effetti CNS oħra li jinkludu atteġġjament aggressiv (xi drabi kontra individwi oħra, bħal ħsibijiet dwar omiċidju), disturbi bipolari, manija, konfużjoni u tibdil fl-istat mentali dehru b'alfa interferons.
English: th percentile).
Maltese: U KWANTITATTIVA
English: Caucasian patients had a higher sustained virologic response rate compared to the African Americans.
Maltese: Il-pazjenti Kawkażi kellhom rati ta' rispons viroloġiku sostnut ogħla meta mqabbla ma' l-Afrikani Amerikani.
English: The pharmacokinetics of ribavirin is altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Maltese: Il-farmakokinetika ta' ribavirin tinbidel f'pazjenti b'disfunzjoni tal-kliewi minħabba t-tnaqqis tattneħħija apparenti tal-krejatinina f'dawn il-pazjenti (ara sezzjoni 5.2).
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 għal Ishak) fost dawk li ma kellhomx rispons.
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
Maltese: Infezzjoni tal-fungu, infezzjoni tal-batteri, infezzjoni pulmonari, nażofarinġite, farinġite bi streptokokki, otitis media, sinużite, snien jitħaffru, influwenza, herpes fil-ħalq, herpes simplex, infezzjoni fil-passaġġ ta'l-awrina, vaġinite, gastroenterite
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: Psorajiżi, psorajiżi taggrava, ekżema, reazzjoni ta' fotosensittività, raxx makulopapulari, raxx ħamrani, issir għarqan bil-lejl, iperidrożi, dermatite, akne, furunkolite , eritema, urtikarja, disturbi tal-ġilda, tbenġil, żieda fl-għaraq, għamla tax-xagħar anormali, disturbi fid-dwiefer*
English: There is no evidence that ribavirin interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
Maltese: M'hemm l-ebda evidenza li ribavirin jagħmel xi interazzjoni ma' l-impedituri li mhumiex nuklejosidi tar-reverse transcriptase jew impedituri protease.
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin Mylan must be discontinued immediately and appropriate medical therapy instituted.
Maltese: Jekk tiżvillupa reazzjoni minħabba sensittività eċċessiva akuta (eż., urtikarja, anġoedema, jingħalqu lbronki, anafilassi), Ribavirin Mylan għandu jitwaqqaf minnufih u tinbeda terapija medika xierqa.
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 ta' studji in vitro li użaw preparazzjonijiet ta' mikrożomi tal-fwied kemm umani kif ukoll tal-firien ma' indikaw l-ebda metaboliżmu ta' ribavirin medjat mill-enżima tas-cytochrome P450.
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of ribavirin is available.
Maltese: Għal tfal u adolexxenti li ma jistgħux jibilgħu kapsula iebsa, hemm soluzzjoni orali ta' ribavirin.
English: Among children and adolescents, treated with Ribavirin in combination with interferon alfa2b, 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: Fost tfal u adolexxenti, kkurati b' ribavirin kombinat ma' interferon alfa-2b, każijiet ta' fissazzjoni jew tentattivi ta' suwiċidju kienu rrappurtati b'mod aktar frekwenti milli f'pazjenti adulti (2.4 % kontra 1 %) waqt ilkura u waqt il-perijodu ta' 6-xhur ta' wara l-kura.
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 (20 %) 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: Suicidal ideation, aggression, confusion, affect liability, behaviour disorder, agitation, somnambulism, anxiety, mood altered, restlessness, nervousness, sleep disorder, abnormal dreaming, apathy
Maltese: Ħsibijiet dwar suwiċidju, aggressjoni, konfużjoni, effetti ta' tixkil, disturbi fl-imġiba, aġitazzjoni, sonnambuliżmu, ansjetà, burdata mibdula, aġitazzjoni, nervi, disturbi ta' l-irqad, ħolm anormali, apatija
English: Periodontal disorder, dental disorder, tongue pigmentation
Maltese: Disturbi paradentali, disturbi fis-snien, pigmentazzjoni flilsien
English: In 3- and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm, occurred at doses of 15 mg/kg and above.
Maltese: Fi studji ta' 3 u 6 xhur fuq il-ġrieden biex ikunu investigati l-effetti testikulari u ta' l-isperma kkaġunati minn ribavirin, anormalitajiet fl-isperma seħħew f'dożi ta' 15 mg/kg u aktar.
English: In children and adolescent patients treated with Ribavirin Mylan plus interferon alfa-2b, reduce Ribavirin Mylan dose to 7.5 mg/kg/day.
Maltese: F'pazjenti tfal u adolexxenti kkurati b'Ribavirin Mylan flimkien ma' interferon alfa-2b, naqqas iddoża ta' Ribavirin Mylan għal 7.5 mg/kg/kuljum.
English: Note 2: In adult patients and children and adolescent patients treated with Ribavirin Mylan plus interferon alfa-2b, reduce the interferon alfa-2b dose by one-half dose.
Maltese: Nota 2: F'pazjenti adulti u tfal u adolexxenti kkurati b'Ribavirin Mylan flimkien ma' interferon alfa2b, naqqas id-doża ta' interferon alfa-2b b'nofs doża.
English: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Maltese: Waqt terapija kombinata għal 48 ġimgħa b'interferon alfa-2b pegilat u ribavirin, ġiet osservata inibizzjoni tat-tkabbir li rriżultat f'tul imnaqqas f'xi pazjenti (ara sezzjoni 4.4).
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and pegylated interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Maltese: Minħabba nuqqas ta' dejta fi tfal bi progressjoni severa tal-marda, u l-potenzjal ta' effetti mhux mixtieqa, il-benefiċċju/riskju tal-kombinazzjoni ta' ribavirin u interferon alfa-2b pegilat għandu jitqies b'attenzjoni f'din il-popolazzjoni (ara sezzjonijiet 4.1, 4.4 u 4.8).
English: For patients with prior failure on therapy with non-pegylated interferon or pegylated interferon and negative at week 12, the sustained response rates were 59 % and 50 %, respectively.
Maltese: Għall-pazjenti li kienu fallew għat-terapija li kienet ingħatat qabel b'interferon mhux pegilat jew interferon pegilat u negattivi ma' ġimgħa 12, it-rati ta' rispons sostnut kienu 59 % u 50 %, rispettivament.
English: During combination therapy for up to 48 weeks with interferon alfa-2b and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
Maltese: Waqt terapija kombinata li damet sa' 48 ġimgħa b'interferon alfa-2b u ribavirin, ġiet osservata inibizzjoni tat-tkabbir li rriżultat f'tul imnaqqas fl-adulti f'xi pazjenti.
English: Adult Patients (18 years of age or older): Ribavirin Mylan 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 serum HCV-RNA (see section 4.4).
Maltese: Pazjenti Adulti (li għandhom 18-il sena jew aktar): Ribavirin Mylan hu indikat flimkien ma' prodotti mediċinali oħra għall-kura ta' epatite Ċ kronika (CHC) għal pazjenti pedjatriċi (tfal li għandhom 3 snin u ikbar u adolexxenti) li ma kinux ikkurati fil-passat u mingħajr dikumpensazzjoni tal-fwied (ara sezzjonijiet 4.4).
English: In combination with peginterferon alfa-2b
Maltese: F'taħlita ma' peginterferon alfa-2b
English: Sustained virological response in previously untreated children and adolescents Ribavirin 15 mg/kg/day interferon alfa-2b 3 MIU/m2 3 times a week
Maltese: Rati ta' rispons viroloġiku sostnut fi tfal u adolexxenti li ma kienux kurati qabel Ribavirin 15 mg/kg/jum interferon alfa-2b 3 MIU/m
English: Fertility
Maltese: - Fertilità:
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 segwiti minn 0.5 mikrogrammi/kg/ġimgħa għal 11-il xahar) (n = 514).
English: HVL
Maltese: SVR
English: Ribavirin (800-1,200 mg/da y)d interferon alfa-2b (3 MIU TIW)
Maltese: Ribavirin (1,000/1,200 mg/jum) + interferon alfa-2b (3 MIU tlett darbiet fil-ġimgħa)
English: Baseline Viral Load
Maltese: Valur Imbassar Pożittiv
English: Unit Dose Blisters:
Maltese: Tkabbir u żvilupp:
English: Rarely reported side effects (may affect up to 1 in 1,000 people): seizure (convulsions), pneumonia, rheumatoid arthritis, kidney problems, dark or bloody stools, intense abdominal pain, sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands), vasculitis.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1,000 persuna): aċċessjoni (konvulsjoni), pnewmonja, artrite rewmatika,, problemi fil-kliewi, purgar skur jew bid-demm, uġigħ ta' żaqq qawwi, sarkojdożi (marda li l-karatteristika tagħha hija deni persistenti, telf tal-piż, uġigħ fil-ġogi u nefħa, feriti fil-ġilda u glandoli minfuħin), vaskulite.
English: Hyperthyroidism, virilism Metabolism and nutrition disorders Very common:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna:
English: Neoplasm unspecified Blood and lymphatic system disorders Very common:
Maltese: Disturbi fis-sistema immuni Mhux komuni:
English: Mouth ulceration, stomatitis ulcerative, stomatitis, aphthous stomatitis, dyspepsia, cheilosis, glossitis, gastroesophoageal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder, stomach discomfort, oral pain
Maltese: Ulċera fil-ħalq, stomatite b'ulċera, stomatite, stomatite b'afti, dispepsja, keljożi, glossite, ittella' mill-istonku, disturbi firrektum, disturbi gastro-intestinali, stitikezza, ippurgar maħlul, uġigħ tas-snien, disturbi fis-snien, skumdità fl-istonku, uġigħ filħalq
English: Gingivitis
Maltese: Irkadew
English: The overall sustained response rate after a 24-week treatment duration was 50%.
Maltese: Ir-rata globali tar-rispons sostnut wara kura ta' 24-ġimgħa kienet 50 %.
English: In a juvenile rat toxicity study, pups dosed from postnatal day 7 to 63 with 10, 25 and 50 mg/kg of ribavirin demonstrated a dose-related decrease in overall growth, which was subsequently manifested as slight decreases in body weight, crown-rump length and bone length.
Maltese: Fi studju dwar firien ta' età żgħira, frieħ li ngħataw doża bejn 7 u 63 jum wara t-twelid b'10, 25 u 50 mg/kg ta' ribavirin urew tnaqqis ġenerali fit-tkabbir skont id-doża, li wara deher bħala tnaqqis żgħir fil-piż tal-ġisem, it-tul tal-crown rump u t-tul ta' l-għadam.
English: Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Mylan may be used in combination with peginterferon alfa-2b or interferon alfa-2b (see section 4.4).
Maltese: Pazjenti pedjatriċi (tfal li għandhom 3 snin u ikbar u adolexxenti) Ribavirin Mylan jista' jintuża flimkien ma' peginterferon alfa-2b jew interferon alfa-2b (ara sezzjoni 4.4).
English: Ribavirin Mylan must be used in combination therapy as described in section 4.1.
Maltese: Ribavirin Mylan għandu jintuża f'terapija kombinata kif deskritt f'sezzjoni 4.1.
English: Reported adverse reactions listed in Table 6 are based on experience from the two multicentre children and adolescents clinical trials using ribavirin with interferon alfa-2b or peginterferon alfa-2b.
Maltese: Reazzjonijiet avversi elenkati f'Tabella 6 huma bbażati fuq esperjenza minn żewġ provi kliniċi multiċentriċi fuq tfal u adolexxenti b'ribavirin ma' interferon alfa-2b jew peginterferon alfa-2b.
English: Treatment with ribavirin in combination with peginterferon alfa-2b was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Maltese: Kura b'ribavirin f'kombinazzjoni ma' peginterferon alfa-2b kienet assoċjata ma' tnaqqis fl-għadd assolut ta' ċelluli CD4+ fl-ewwel 4 ġimgħat mingħajr tnaqqis fil-perċentwali taċ-ċelluli CD4+.