FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3 Management of Adverse Reactions Laboratory values
Maltese: Tabella 3 Immaniġġjar ta' Reazzjonijiet Avversi
English: Rebetol in combination with peginterferon alfa-2b Multiple-dose pharmacokinetic properties for Rebetol and peginterferon alfa-2b in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
Maltese: Il-kwalitajiet farmakokinetiċi ta' dożi multipli ta' Rebetol u peginterferon alfa-2b f'pazjenti tfal u adolexxenti b'epatite Ċ kronika kienu evalwati waqt studju kliniku.
English: Cutaneous sarcoidosis
Maltese: Kolite iskemika
English: Rhabdomyolysis*, myositis*
Maltese: Il-pakkett ta' ġewwa (Il-folja)
English: The combination of Rebetol and other medicines is used to treat patients who have chronic hepatitis C (HCV).
Maltese: kronika (HCV - chronic hepatitis C).
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 fl-irqad, ħolm anormali, apatija
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: Glycerol
Maltese: Il-Belġju
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 fir-rektum, disturbi gastro-intestinali, stitikezza, ippurgar maħlul, uġigħ tas-snien, disturbi fis-snien,
English: • Rebetol (1,000/1,200 mg/day) + interferon alfa-2b (3 MIU three times a week) (n = 505).
Maltese: • Rebetol (1,000/1,200 mg/jum) + interferon alfa-2b (3 MIU tlett darbiet fil-ġimgħa)
English: No pharmacokinetic interactions were noted between Rebetol and interferon alfa-2b in a multiple-dose pharmacokinetic study.
Maltese: L-ebda interazzjonijiet farmakokinetiċi ma kienu nnotati bejn Rebetol u interferon alfa-2b fi studju dwar il-farmakokinetika b'dożi multipli.
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.
Maltese: B'mod ġenerali, il-profil ta' reazzjonijiet avversi fil-popolazzjoni limitata tat-tfal u adolexxenti kien jixbah lil dak tal-adulti, għalkemm hemm tħassib speċifiku għat-tfal dwar l-inibizzjoni tat-tkabbir peress li tnaqqis fil-perċentwali tat-tul (perċentwali medja ta' tnaqqis ta' 9 fil-mija) u fil-perċentwali tal-piż
English: Table 4 Dosage Modification for Renal Impairment in Adult Patients Creatinine Clearance
Maltese: Tabella 4 Bidla fid-Dożaġġ għal Indeboliment tal-Kliewi f'Pazjenti Adulti
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 mmaniġġjati bi tnaqqis fid-doża, monitoraġġ mill-qrib ta' parametri ematoloġiċi għandu jsir f'din il-popolazzjoni ta' pazjenti (ara sezzjonijiet 4.2 u hawn taħt “Testijiet tal-laboratorju” u sezzjoni 4.8).
English: Amnesia, memory impairment, syncope, migraine, ataxia, paraesthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, hypertonia, somnolence, disturbance in attention, tremor, dysgeusia
Maltese: Amnesija, tixkil fil-memorja, sinkope, emigranja, ataksja, paraesteżija, disfonija, telf tat-togħma, ipoesteżija, iperesteżija, ipertonja, ngħas, disturbi fl-attenzjoni, tregħid, disġewżja
English: Treatment with Rebetol 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'Rebetol 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+.
English: Patients whose dose of Rebetol is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Maltese: Pazjenti li jkollhom id-doża ta' Rebetol tagħhom imnaqqsa għal 600 mg kuljum jirċievu kapsula waħda ta' 200 mg filgħodu u żewġ kapsuli ta' 200 mg filgħaxija.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Maltese: Studju 2 (P02080) kien randomized, f'ċentru wieħed li fih ħadu sehem 95 pazjent adult li ma kinux ikkurati qabel b'epatite Ċ kronika li kellhom l-HIV fl-istess ħin.
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 Rebetol 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' Rebetol u interferon alfa-2b pegilat għandu jitqies b'attenzjoni f'din il-popolazzjoni (ara sezzjonijiet 4.1, 4.4 u 4.8).
English: Periodontal disorder, dental disorder, tongue pigmentation
Maltese: Disturbi fil-pigmentazzjoni, dermatite atopika, esfoljazzjoni tal-ġilda
English: Anti-thyroid antibody positive
Maltese: Antikorp kontra t-tirojde pożittiv
English: Rebetol in combination with interferon alfa-2b
Maltese: Rebetol f'kombinazzjoni ma' interferon alfa-2b
English: Hepatomegaly, jaundice, hyperbilirubinemia*
Maltese: Dijabete mellitus, ipertrigliċeridimja*
English: 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 Rebetol 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 Rebetol flimkien ma' azathioprine.
English: In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when Rebetol is administered.
Maltese: it-tobba għandhom josservaw b'attenzjoni l-indikaturi ta' tossiċità mitokondrijali u aċidożi lattika meta jingħata Rebetol.
English: Patients were randomized to receive either Rebetol (800-1,200 mg/day based on weight) plus peginterferon alfa-2b (100 or 150 µg/week based on weight) or Rebetol (800-1,200 mg/day based on weight) plus interferon alfa-2b (3 MIU TIW).
Maltese: Il-pazjenti kienu randomized biex jirċievu Rebetol (800-1,200 mg/jum skont il-piż) ma' peginterferon alfa-2b (100 jew 150 µg/ġimgħa skont il-piż) jew Rebetol (800-1,200 mg/jum skont il-piż) ma' interferon alfa-2b (3 MIU TIW).
English: Table 4 Adverse reactions very commonly, commonly and uncommonly reported during clinical trials in children and adolescents with Rebetol in combination with interferon alfa-2b or peginterferon alfa-2b System Organ Class
Maltese: Tabella 4 Reazzjonijiet avversi rrappurtati b'mod komuni ħafna, komuni jew mhux komuni waqt provi kliniċi fi tfal u adolexxenti b'Rebetol ma' interferon alfa-2b jew peginterferon alfa-2b
English: - Pregnancy (see sections 4.4, 4.6 and 5.3).
Maltese: mhux ittrattati qabel u mingħajr dekompensazzjoni tal-fwied (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: 2 capsules in the morning and 2 capsules in the evening See adult dose
Maltese: 2 kapsuli filgħodu u 2 kapsuli filgħaxija
English: Each capsule contains 200 mg of ribavirin.
Maltese: Kull kapsula iebsa fiha 200 mg ta' ribavirin.
English: Rinse:
Maltese: Rebetol jekk:
English: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and Rebetol, 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 Rebetol, dehret inibizzjoni tat-tkabbir li f'xi pazjenti wasslet għal tnaqqis fit-tul (ara sezzjoni 4.4).
English: Table 6 Adverse reactions very commonly, commonly and uncommonly reported during clinical trials in children and adolescents with Rebetol in combination with interferon alfa-2b or peginterferon alfa-2b System Organ Class
Maltese: Tabella 6 Reazzjonijiet avversi irrappurtati b'mod komuni ħafna, komuni jew mhux komuni waqt provi kliniċi fi tfal u adolexxenti b'Rebetol ma' interferon alfa-2b jew peginterferon alfa-2b
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 HCV/HIV fl-istess ħin, hemm disponibbli dejta limitata dwar l-effikaċja u s-sigurtà (N=25) f'individwi b'għadd tas-CD4 anqas minn 200 ċellula/µL.
English: * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, Rebetol dose should be reduced to 600 mg/day (administered as one 200 mg capsule in the morning and two 200 mg capsules in the evening).
Maltese: * Għal pazjenti li qed jirċievu doża ta' 1,000 mg (< 75 kg) jew 1,200 mg (> 75 kg), id-doża ta' Rebetol għandha titnaqqs għal 600 mg/jum (mogħtija bħala kapsula waħda ta' 200 mg filgħodu u żewġ kapsuli ta' 200 mg filgħaxija).
English: This should be discussed with your doctor (see section “Do not take Rebetol”).
Maltese: Dan għandek tiddiskutih mat-tabib tiegħek (ara sezzjoni “Tiħux Rebetol”).
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Rebetol must be discontinued immediately and appropriate medical therapy instituted.
Maltese: Jekk tiżviluppa reazzjoni minħabba sensittività eċċessiva akuta (eż., urtikarja, anġoedima, jingħalqu l-bronki, anafilassi), Rebetol għandu jitwaqqaf minnufih u tinbeda terapija medika xierqa.
English: Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment.
Maltese: (ARV - antiretrovirali) kif ukoll kura kontra l-epatite għandhom ikunu mmonitorjati mill-qrib, bi stima tal-punteġġ ta' Child-Pugh tagħhom waqt it-trattament.
English: Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhoea, sneezing, pharyngolaryngeal pain
Maltese: eritema, urtikarja, disturbi tal-ġilda, tbenġil, żieda fl-għaraq, għamla tax-xagħar anormali, disturbi fid-dwiefer*
English: Female: amenorrhea, menorrhagia, menstrual disorder, dysmenorrhea, breast pain, ovarian disorder, vaginal disorder.
Maltese: Mara: amenorrea, mestrwazzjoni esaġerata, disturbi mestruwali, dismenorrea, uġigħ fis-sider, disturbi fl-ovarji, disturb vaġinali.
English: Pallor, flushing
Maltese: Isir pallidu, fwawar
English: Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Maltese: It-tul adult finali kien disponibbli għal 14 minn dawk it-tfal u wera li 12 komplew juru nuqqas ta' > 15-il perċentwali, 10 sa
English: Table 1 Rebetol oral solution - Children and adolescents dosage to be administered with interferon alfa-2b or peginterferon alfa-2b Body Weight (kg)
Maltese: Tabella 1 Soluzzjoni orali ta' Rebetol - Id-doża li għandha tingħata ma' interferon alfa-2b jew peginterferon alfa-2b lil tfal u adolexxenti Piż tal-Ġisem (kg)
English: Rebetol Dose (daily)
Maltese: Doża ta' Rebetol (kuljum)
English: Ischaemic colitis
Maltese: msdeesti@merck.com
English: Tel: +386 1 5204 201 msd.slovenia@merck.com
Maltese: msd.slovenia@merck.com
English: The ratio of whole blood:plasma ribavirin concentrations is approximately 60:1; the excess of ribavirin in whole blood exists as ribavirin nucleotides sequestered in erythrocytes.
Maltese: Il-proporzjon ta' demm sħih:konċentrazzjonijiet ta' ribavirin fil-plażma huwa ta' madwar 60:1; ribavirin żejjed fid-demm sħih jeżisti bħala nuklejotidi ta' ribavirin li jinsabu fl-eritroċiti.
English: Neuropathy, peripheral neuropathy
Maltese: Newropatija, newropatija periferali
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 fuq it-testikuli u l-isperma kkaġunati minn ribavirin, anormalitajiet fl-isperma seħħew b'dożi ta' 15 mg/kg u aktar.
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 tal-individwi (97/235) kellhom livelli ta' HCV-RNA li ma setgħux jitkejjlu mar-4 ġimgħa u mal-24 ġimgħa tat-terapija.
English: Baseline Viral Load
Maltese: Valur Imbassar
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-Rebetol 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' Rebetol għall-infezzjoni fl-istess ħin b'HCV (ara sezzjoni 4.4).
English: REBETOL - 84, 112, 140, 168 hard capsules
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA REBETOL - 84, 112, 140, 168 kapsuli ibsin
English: > 5 mg/dL (for > 4 weeks) (children and adolescents treated with interferon alfa-2b), or > 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b) * In children and adolescent patients treated with Rebetol plus peginterferon alfa-2b, 1
Maltese: > 4 mg/dL (għal > 4 ġimgħat) (tfal u adolexxenti ttrattati b'peginterferon alfa-2b) * F'pazjenti tfal u adolexxenti ttrattati b'Rebetol ma' peginterferon alfa-2b, l-1el tnaqqis fid-doża ta'
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: 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: Anorexia, increased appetite, decreased appetite
Maltese: Anoressija, żieda fl-aptit, tnaqqis fl-aptit
English: This solution is packaged in 118 mL size amber glass bottles containing 100 mL of oral solution.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT soluzzjoni orali flixkun 1 ta' 100 mL
English: Hepatic decompensation in HCV/HIV co-infected patients with advanced cirrhosis Co-infected patients with advanced cirrhosis receiving combined anti-retroviral therapy (cART) may be at increased risk of hepatic decompensation and death.
Maltese: Pazjenti infettati fl-istess ħin li jkollhom ċirrożi avanzata u li jkunu qed jirċievu terapija antiretrovirali kombinata (cART - combined anti-retroviral therapy) jista' jkollhom riskju akbar ta'
English: UAB Merck Sharp & Dohme Tel. +370 5 278 02 47 msd_lietuva@merck.com
Maltese: L-effetti fuq it-tkabbir kienu inqas f'dawk it-tfal ikkurati għal 24 ġimgħa milli f'dawk ikkurati għal 48 ġimgħa.
English: Facial palsy, mononeuropathies
Maltese: Paraliżi tal-wiċċ, mononwropatiji
English: The combination of Rebetol and other medicines is used to treat adult patients who have chronic hepatitis C (HCV).
Maltese: Il-kombinazzjoni ta' Rebetol u mediċini oħra tintuża biex jiġu ttrattati pazjenti adulti li għandhom epatite Ċ kronika (HCV - chronic hepatitis C).
English: Reported adverse reactions listed in Table 6 are based on experience from the two multicentre children and adolescents clinical trials using Rebetol with interferon alfa-2b or peginterferon alfa-2b.
Maltese: Reazzjonijiet avversi rrappurtati elenkati f'Tabella 6 huma bbażati fuq esperjenza minn żewġ provi kliniċi multiċentriċi fuq tfal u adolexxenti b'Rebetol ma' interferon alfa-2b jew peginterferon alfa-2b.
English: Psychiatric disorders Very common:
Maltese: Disturbi psikjatriċi Komuni ħafna:
English: Both the Metavir score and Ishak grade decreased among subjects treated with Rebetol in combination with peginterferon alfa-2b.
Maltese: Kemm il-punteġġ Metavir u l-grad Ishak naqsu fost l-individwi kkkurati b'Rebetol f'kombinazzjoni ma' peginterferon alfa-2b.
English: Please refer to the corresponding SmPC of medicinal products that are used in combination with Rebetol for additional undesirable effects reported with these products.
Maltese: Rebetol għal effetti addizzjonali mhux mixtieqa rrappurtati b'dawn il-prodotti.
English: Patients were randomized to receive either Rebetol (800 mg/day) plus peginterferon alfa-2b (1.5 µg/kg/week) or Rebetol (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 Rebetol (800 mg/jum) ma' peginterferon alfa-2b (1.5 µg/kg/ġimgħa) jew Rebetol (800 mg/jum) ma' interferon alfa-2b (3 MIU TIW) għal 48 ġimgħa b'perijodu ta' follow up ta' 6 xhur.
English: The following side effects have been reported with the combination of this medicineand an interferon alfa-2b product in children and adolescents:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati bil-kombinazzjoni ta' din il-mediċina u prodott interferon alfa-2b fi tfal u adolexxenti:
English: This product contains sucrose and sorbitol.
Maltese: Din il-mediċina fiha sucrose u sorbitol.
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 Rebetol 15 mg/kg per day plus interferon alfa-2b 3 MIU/m2 three times a week for 1 year followed by 6 months follow-up after-treatment.
Maltese: Tfal u adolexxenti minn 3 snin sa 16-il sena b'epatite Ċ kronika kkumpensata u HCV-RNA li setgħet titkejjel (imkejjel minn laboratorju ċentrali bl-użu ta' assaġġ ta' RT-PCR li jintuża għar-riċerka) kienu reklutati f'żewġ provi multiċentriċi u rċevew Rebetol 15 mg/kg kull jum ma' interferon alfa-2b
English: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite
Maltese: Ipergliċemija, iperuriċemija, ipokalċemija, deidrazzjoni, żieda fl-aptit
English: Reported adverse reactions listed in Table 4 are based on experience from the two multicentre children and adolescents clinical trials using Rebetol with interferon alfa-2b or peginterferon alfa-2b.
Maltese: Reazzjonijiet avversi elenkati f'Tabella 4 huma bbażati fuq esperjenza minn żewġ provi kliniċi multiċentriċi fuq tfal u adolexxenti b'Rebetol ma' interferon alfa-2b jew peginterferon alfa-2b.
English: peginterferon alfa-2b (100 or c µg/week)
Maltese: peginterferon alfa-2b (100
English: Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with non-pegylated interferon alfa-2b (with or without Rebetol) and pegylated interferon alfa-2b (with or without Rebetol), respectively.
Maltese: Żewġ studji kbar ta' follow up fit-tul ta' 1,071 pazjent u 567 pazjent wara kura fi studji minn qabel b'interferon alfa-2b mhux pegilat (b'Rebetol jew mingħajru) u interferon alfa-2b pegilat (b'Rebetol jew mingħajru), rispettivament.
English: Rebetol in combination with peginterferon alfa-2b Children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCV-RNA were enrolled in a multicentre trial and treated with Rebetol 15 mg/kg per day plus pegylated interferon alfa-2b 60 µg/m2 once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Maltese: Rebetol flimkien ma' interferon alfa-2b Tfal u adolexxenti minn 3 snin sa 16-il sena b'epatite Ċ kronika kkumpensata u HCV-RNA li setgħet titkejjel (imkejjel minn laboratorju ċentrali bl-użu ta' assaġġ ta' RT-PCR li jintuża għar-riċerka) kienu reklutati f'żewġ provi multiċentriċi u rċevew Rebetol 15 mg/kg kull jum ma' interferon alfa-2b
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of this medicine is available.
Maltese: Għal tfal u adolexxenti li ma jistgħux jibilgħu kapsula iebsa, hemm soluzzjoni orali ta' din il-mediċina.
English: * Since Rebetol has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using Rebetol in combination with interferon alfa-2b (pegylated or non-pegylated).
Maltese: *Minħabba li Rebetol dejjem ġie ordnat ma' prodott alfa interferon, u r-reazzjonijiet avversi tal-mediċina elenkati li kienu inklużi kienu jirriflettu esperjenza ta' wara t-tqegħid fis-suq li ma tippermettix li tiġi kwantifikata b'mod preċiż il-frekwenza, il-frekwenza rrappurtata hawn fuq inkisbet minn provi kliniċi fejn intuża Rebetol f'taħlita ma' interferon alfa-2b (pegilat jew mhux pegilat).
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,
English: % (number) of patients peginterferon alfa-2b 1.5 µg/kg + Rebetol peginterferon alfa-2b 1 µg/kg + Rebetol peginterferon alfa-2a 180 µg + ribavirin
Maltese: F'din il-prova, it-taħlita ta' Rebetol u peginterferon alfa-2b (1.5 mikrogrammi/kg/ġimgħa) kienet aktar effettiva b'mod sinifikanti mit-taħlita ta' Rebetol u interferon alfa-2b, b'mod partikolari f'pazjenti infettati bil-Ġenotip 1.
English: • are breast-feeding.
Maltese: • għandkom problemi bil-kliewi.
English: No pharmacokinetic interaction appears between Rebetol and hepatic function (see section 5.2).
Maltese: Ma tidher l-ebda interazzjoni farmakokinetika bejn Rebetol u l-funzjoni tal-fwied (ara sezzjoni 5.2).
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 sal-aħħar tas-segwitu fit-tul ta' 5 snin, il-perċentwali tal-BMI għall-età naqsu b'1.8 u 7.5
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of peginterferon alfa-2b and Rebetol, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
Maltese: Fi prova klinika b'107 pazjent tifel u tifla u adolexxenti (3 sa 17-il sena) ikkurati b'terapija kombinata ta' peginterferon alfa-2b u Rebetol, bidliet fid-doża kienu meħtieġa f'25 % tal-pazjenti, l-aktar komuni minħabba anemija, newtropenija jew telf tal-piż.
English: Rebetol (800 mg/day)
Maltese: (800 mg/jum)
English: The recommended dose of Rebetol combined with interferon alfa-2b or peginterferon alfa-2b, is shown in the below table.
Maltese: Id-doża rrakkomadata ta' Rebetol mogħti flimkien ma' interferon alfa-2b jew peginterferon alfa-2b, qed tintwera fit-tabella taħt.