FrancophonIA/ELRC3.0 huggingface dataset:
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, 1,530 pazjent li qatt ma ħadu kura qabel kienu kkurati għal sena b'wieħed minn dawn il-korsijiet imħallta li ġejjin:
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 mir-retina*, retinopatiji (inkluż edima makulari)*, sadd tal-arterja tar-retina*, sadd tal-vina tar-retina*, nevrite ottika*, papillo-edima*, telf tal-akutezza tal-vista jew tal-medda viżiva*, tnixxijiet mir-retina Disturbi fil-widnejn u fis-sistema labirintika Komuni:
English: There is no evidence that Rebetol interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
Maltese: M'hemm l-ebda evidenza li Rebetol jagħmel xi interazzjoni mal-impedituri li mhumiex nuklejosidi tar-reverse transcriptase jew impedituri tal-protease.
English: Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
Maltese: Tel: 0800 9999000 (+31 23 5153153)
English: Depression, insomnia, emotional lability
Maltese: Dipressjoni, insomnja, burdati emozzjonali
English: During combination therapy for up to 48 weeks with interferon alfa-2b and Rebetol, growth inhibition was observed that resulted in reduced final adult height in some patients.
Maltese: Waqt terapija kkombinata li damet sa' 48 ġimgħa b'interferon alfa-2b u Rebetol, inibizzjoni tat-tkabbir dehret li wasslet għal tnaqqis fit-tul adult finali f'xi pazjenti.
English: In clinical trials with Rebetol used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of Rebetol (50 x 200 mg capsules) 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'Rebetol użat flimkien ma' interferon alfa-2b, id-doża eċċessiva massima rrappurtata kienet doża totali ta' 10 g ta' Rebetol (50 kapsula ta' 200 mg) u 39 MIU ta' interferon alfa-2b (13-il injezzjoni taħt il-ġilda ta' 3 MIU kull waħda) meħuda f'ġurnata waħda minn pazjent f'tentattiv ta' suwiċidju.
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 pankreatite, ftit minnhom fatali, kienu rrappurtati (ara sezzjoni 4.4).
English: Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 12).
Maltese: Rispons Viroloġiku Sostnut (SVR) huwa definit bħala HCV-RNA li ma jistax jitkejjel mal-24 ġimgħa wara l-kura (Tabella 12).
English: Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of Rebetol.
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' Rebetol medjat mill-enzima tas-cytochrome P450.
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) tal-individwi kollha u kienu jinkludu uġigħ fis-sit tal-injezzjoni (1 %), uġigħ fl-estremitajiet (1 %), uġigħ ta' ras (1 %), newtropenija (1 %) u temperatura għolja (4 %).
English: In children and adolescent patients receiving body surface area-adjusted dosing of peginterferon alfa-2b at 60 µg/m2/week, the log transformed ratio estimate of exposure during the dosing interval is predicted to be 58 % (90 % CI: 141-177 %) higher than observed in adults receiving 1.5 µg/kg/week.
Maltese: F'pazjenti tfal u adolexxenti li kienu qed jirċievu dożaġġi ta' peginterferon alfa-2b aġġustati skont is-superfiċje tal-ġisem ta' 60 μg/m2/ġimgħa, l-istima tal-proporzjon log mibdul tal-esponiment waqt l-interval bejn id-dożaġġi huwa mbassar li jkun 58 % (90 % CI: 141-177 %) ogħla minn dak osservat f'adulti li kienu qed jirċievu 1.5 μg/kg/ġimgħa.
English: Each mL of oral solution contains 40 mg of ribavirin.
Maltese: Kull mL tas-soluzzjoni orali fih 40 mg ta' ribavirin.
English: - Retreatment of relapse patients with Rebetol and interferon alfa-2b combination treatment Two trials examined the use of Rebetol 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' Rebetol ma' interferon alfa-2bŻewġ studji li eżaminaw l-użu tal-kura mħallta ta' Rebetol + 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: Haematological abnormalities in HCV/HIV co-infected patients HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and cART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
Maltese: F'pazjenti li fl-istess ħin ikunu infettati b'HCV/HIV li jkunu qed jirċievu trattament b'peginterferon alfa-2b/ribavirin u cART jista' jkollhom riskju akbar li jiżviluppaw anormalitajiet ematoloġiċi (bħal newtropenija, tromboċitopenija u anemija) meta mqabbla ma' pazjenti infettati b'HCV biss.
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, id-defiċjenza ta' Lapp Lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: MIU = million international units; TIW = three times a week.
Maltese: MIU = miljun unitajiet internazzjonali;
English: Other medicines with Rebetol
Maltese: Mediċini oħra u Rebetol
English: In addition, in a 26 week carcinogenicity study using the heterozygous p53(+/-) mouse model, ribavirin did not produce tumours at the maximally tolerated dose of 300 mg/kg (plasma exposure factor approximately 2.5 compared to human exposure).
Maltese: ġimgħa bl-użu tal-mudell heterozygous p53(+/-) tal-ġurdien, ribavirin ma kkawżax tumuri fid-doża massima ttolerata ta' 300 mg/kg (fattur tal-espożizzjoni fil-plażma ta' madwar 2.5 meta mqabbel mal-espożizzjoni umana).
English: Arthritis, back pain, muscle spasms, pain in extremity
Maltese: Artrite, uġigħ fid-dahar, spażmi fil-muskoli, uġigħ fl-estremità
English: Tel: +43 (0) 1 26 044 msd-medizin@merck.com
Maltese: Tel: +43 (0) 1 26 044
English: There were some cases of more severe neutropenia in patients treated with Rebetol in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]); WHO grade 3 leukopenia was also reported in 7 % of this treatment group.
Maltese: Kien hemm xi każijiet ta' newtropenja aktar severa f'pazjenti kkurati b'Rebetol flimkien ma' peginterferon alfa-2b (grad tal-WHO 3: 39 minn 186 [21 %]; u grad 4 tal-WHO: 13 minn 186
English: Note: For patients who weigh < 47 kg, or are unable to swallow capsules, please refer to the SmPC for Rebetol 40 mg/mL oral solution.
Maltese: Nota: Għal pazjenti li jiżnu < 47 kg, jew li ma jistgħux jibilgħu kapsuli, jekk jogħġbok irreferi għall-SmPC tas-soluzzjoni orali ta' Rebetol 40 mg/mL.
English: Tel: +420 233 010 111 dpoc_czechslovak@merck.com
Maltese: dpoc_czechslovak@merck.com
English: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two peginterferon alfa-2b/Rebetol regimens [peginterferon alfa-2b 1.5 µg/kg and 1 µg/kg subcutaneously once weekly both in combination with Rebetol 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/Rebetol [peginterferon alfa-2b 1.5 µg/kg u 1 µg/kg minn taħt il-ġilda darba fil-ġimgħa kemm flimkien ma' Rebetol 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 li qatt ma ħadu kura qabel b'epatite Ċ kronika ta' ġenotip 1.
English: p value
Maltese: B'mod globali
English: In all three treatment groups, sustained virologic response rates were similar.
Maltese: Fit-tliet gruppi ta' kura kollha, rati ta' rispons viroloġiku sostnut kienu simili.
English: No pharmacokinetic interactions were noted between Rebetol and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
Maltese: Ma kienet innotata l-ebda interazzjoni farmakokinetika bejn Rebetol u peginterferon alfa-2b jew interferon alfa-2b fi studju dwar il-farmakokinetika b'dożi multipli.
English: Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted renally.
Maltese: Kemm ribavirin kif ukoll il-metaboliti tiegħu triazole carboxymide u triazole carboxylic acids jiġu eliminati ukoll mill-kliewi.
English: In combination with peginterferon alfa-2b
Maltese: peginterferon alfa-2b.
English: There are several serious adverse reactions associated with the combination therapy of Rebetol with (peg)interferon alfa.
Maltese: Hemm diversi reazzjonijiet avversi serji assoċjati ma' terapija b'Rebetol fimkien ma' (peg)interferon alfa.
English: In a separate trial, 224 patients with genotype 2 or 3 received peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg -1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 8).
Maltese: Fi prova separata, 224 pazjent b'ġenotip 2 jew 3 ingħataw peginterferon alfa-2b, 1.5 mikrogramma/kg minn taħt il-ġilda, darba fil-ġimgħa, flimkien ma' ribavirin bejn 800 mg u 1,400 mg p.o. għal 6 xhur (bażat fuq il-piż tal-ġisem, kien hemm tlett pazjenti biss li kienu jiżnu > 105 kg, irċevew id-doża ta' 1,400 mg) (Tabella 8).
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); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known.
Maltese: Fost il-klassijiet tas-sistema tal-organi, l-effetti avversi huma mniżżla skont il-frekwenza permezz tal-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 magħruf.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Gingivitis
Maltese: tbenġil
English: Rebetol 40 mg/mL oral solution
Maltese: IL-PRODOTT MEDIĊINALI Rebetol 40 mg/mL soluzzjoni orali
English: Patients who weigh > 47 kg and are able to swallow capsules may take the equivalent dose of ribavirin 200 mg capsules in two divided doses (Please see SmPC for Rebetol capsules).
Maltese: Pazjenti li jiżnu > 47 kg u li jistgħu jibilgħu kapsuli jistgħu jieħdu d-doża ekwivalenti ta'-kapsuli ta' 200 mg ribavirin maqsumin f'żewġ dożi (jekk jogħġbok ara l-SmPC tal-kapsuli Rebetol).
English: Τηλ: +30 210 98 97 300 dpoc_greece@merck.com
Maltese: Τηλ: +30 210 98 97 300
English: HCV-RNA should be measured periodically during treatment (see section 4.2).
Maltese: L-HCV-RNA għandu jitkejjel perjodikament waqt il-kura (ara sezzjoni 4.2).
English: Table 8 Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and Rebetol capsules when administered to paediatric patients with chronic hepatitis C PARAMETER
Maltese: Medja (% CV) tal-parametri farmakokinetiċi ta' ħafna dożi għal interferon alfa-2b u kapsuli Rebetol meta jingħataw lill-pazjenti pedjatriċi b'epatite Ċ kronika Parametru
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 97 % (95 % CI: 95-99 %) for patients receiving non-pegylated interferon alfa-2b (with or without Rebetol), and is 99 % (95 % CI: 98-100 %) for patients receiving pegylated interferon alfa-2b (with or without Rebetol).
Maltese: 95-99 %) għall-pazjenti li kienu qed jirċievu interferon alfa-2b mhux pegilat (b'Rebetol jew mingħajru), u huwa 99 % (95 % CI: 98-100 %) għall-pazjenti li kienu qed jirċievu interferon alfa-2b pegilat (b'Rebetol jew mingħajru).
English: Multiple-dose pharmacokinetic properties for Rebetol capsules and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 8.
Maltese: Il-kwalitajiet farmakokinetiċi ta' dożi multipli għall-kapsuli Rebetol u interferon alfa-2b fi tfal u adolexxenti b'epatite Ċ kronika ta' età bejn 5 u 16-il sena qed jintwerew fil-qosor f'Tabella 8.
English: • Rebetol (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: • Rebetol (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: Number of 200 mg capsules
Maltese: Numru ta' kapsuli ta' 200 mg
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b:
Maltese: Terapija b'żewġ mediċini flimkien ma' peginterferon alfa-2b jew interferon alfa-2b:
English: The concomitant use of Rebetol with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Maltese: L-użu ta' Rebetol flimkien ma' zidovudine mhux irrakkomandat minħabba żieda fir-riskju ta' anemija (ara sezzjoni 4.4).
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, 1
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' Rebetol ikun ta' 200 mg/jum (ħlief li f'pazjenti li jkunu qed jirċievu 1,400 mg, it-tnaqqis fid-doża għandu jkun ta' 400 mg/jum).
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: 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/ribavirin treatment.
Maltese: Għandha tingħata attenzjoni lill-pazjenti pożittivi għall-HIV li huma koinfettati bl-HCV li qed jirċievu kura bl-impedituri ta' nucleoside reverse transcriptase (NRTI) (l-aktar ddI u d4T) u l-kura assoċjata b'interferon alfa/ribavirin.
English: Table 2 Management of Adverse Reactions Laboratory values
Maltese: Tabella 2 Immaniġġjar ta' Reazzjonijiet Avversi
English: Rebetol (800 mg/day) + interferon alfa-2b (3 MIU TIW)
Maltese: (800-1,200 m g/jum)d interferon alfa-2b (3 MIU TIW)
English: This interaction is not considered to be clinically relevant.
Maltese: Din l-interazzjoni mhijiex ikkunsidrata li hi klinikament relevanti.
English: - The other ingredients are: sodium citrate, citric acid, anhydrous, sodium benzoate, glycerol, sucrose, sorbitol liquid (crystallising), propylene glycol, purified water, natural and artificial bubble gum flavouring
Maltese: - Is-sustanza attiva hi ribavirin 40 mg/mL - Is-sustanzi l-oħra huma: sodium citrate, citric acid, anhydrous, sodium benzoate, glycerol,
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' 200-1,200 mg ta'
English: Patients who were HCV-RNA negative at Treatment week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
Maltese: Pazjenti li kienu HCV-RNA negattivi f'Ġimgħa 12 tal-Kura komplew il-kura għal 48 ġimgħa u kienu segwiti għal 24 ġimgħa wara l-kura.
English: For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available.
Maltese: Għal pazjenti pedjatriċi (tfal u adolexxenti) li jiżnu anqas minn 47 kg, teżisti formulazzjoni bħala soluzzjoni.
English: However, absolute bioavailability is approximately 45 %-65 %, which appears to be due to first pass metabolism.
Maltese: Madankollu, il-bijodisponibilità assoluta hija madwar 45 %-65 %, li tidher li hi minħabba l-metaboliżmu tal-ewwel passaġġ .
English: Sarcoidosis*, rheumatoid arthritis (new or aggravated)
Maltese: Sarkojdożi*, artrite rewmatika (toħroġ mill-ġdid jew taggrava)
English: Paediatric patients (children 3 years of age and older and adolescents) Rebetol may be used in combination with peginterferon alfa-2b or interferon alfa-2b (see section 4.4).
Maltese: Pazjenti pedjatriċi (tfal ta' 3 snin u aktar u adolexxenti) Rebetol jista' jintuża flimkien ma' peginterferon alfa-2b jew interferon alfa-2b (ara sezzjoni 4.4).
English: Therefore, there is a minimal potential for P450 enzyme-based interactions.
Maltese: Għalhekk, hemm probabbilita' minima li jseħħu interazzjonijiet abbażi tal-enzima P450.
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 bil-batterji, infezzjoni pulmonari, nażofarinġite, farinġite kkawżata minn streptokokki, otitis media, sinożite, snien jitħaffru, influwenza, herpes fil-ħalq, herpes simplex, infezzjoni fil-passaġġ tal-awrina, vaġinite, gastroenterite
English: Antacid
Maltese: dardir
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 testijiet ematoloġiċi standard, testijiet tal-kimika tad-demm (għadd komplut tad-demm [CBC - complete blood count] u differenzjali, l-għadd tal-plejtlits, elettroliti, kreatinina fis-serum, testijiet tal-funzjoni tal-fwied, aċidu uriku) u testijiet tat-tqala.
English: Haemoglobin levels dropped below 10 g/dL in up to 14 % of adult patients and 7 % of children and adolescents treated with Rebetol in combination with either peginterferon alfa-2b or interferon alfa-2b.
Maltese: Il-livelli tal-emoglobina niżlu għal inqas minn 10 g/dL f'14 % tal-pazjenti adulti u 7 % ta' tfal u adolexxenti kkurati b'Rebetol flimkien ma' peginterferon alfa-2b jew ma' interferon alfa-2b.
English: Table 12 Rates of Response to retreatment in prior treatment failures Patients with undetectable HCV-RNA at treatment week 12 and SVR upon retreatement interferon alpha/ribavirin peginterferon alpha/ribavirin
Maltese: SVR wara kura mill-ġdid interferon alfa/ribavirin peginterferon alfa/ribavirin
English: Table 3 Dosage Modification for Renal Impairment in Adult Patients Creatinine Clearance
Maltese: Tabella 3 Bidla fid-Dożaġġ għal Indeboliment tal-Kliewi f'Pazjenti Adulti
English: Homicidal ideation*, mania*, mental status change
Maltese: Ħsibijiet dwar omiċidju*, manija*, bidla fl-istat mentali
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 ta' 59 % u 50 %, rispettivament.
English: Genotype
Maltese: Epatomegalija
English: Rebetol oral solution 100 mL is packaged in 118 mL amber glass bottles (coloured EP Type IV glass, Ph Eur.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Soluzzjoni orali ta' Rebetol 100 mL hija konfezzjonata fi fliexken tal-ħġieġ kannella fl-oranġjo tal-118 mL (ħġieġ kulurit EP tat-tip IV, Ph. Eur.).
English: Multiple-dose pharmacokinetic properties for Rebetol capsules and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 15.
Maltese: Il-kwalitajiet farmakokinetiċi ta' dożi multipli għall-kapsuli Rebetol u interferon alfa-2b fi tfal u adolexxenti b'epatite Ċ kronika ta' età bejn 5 u 16-il sena qed jintwerew fil-qosor f'Tabella 15.
English: Rebetol (8001,200 mg/day)
Maltese: (800-1,200 m g/jum)d +
English: Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation (see sections 4.2, 4.4, and 5.1).
Maltese: Rebetol flimkien ma' prodotti mediċinali oħra huwa indikat għat-trattament ta' epatite Ċ kronika (CHC - chronic hepatitis C) għal-pazjenti pedjatriċi (tfal ta' 3 snin u aktar u adolexxenti) mhux ittrattati qabel u mingħajr dekompensazzjoni tal-fwied (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: SVR in patients with undetectable HCV-RNA at treatment week 12 *HCV-RNA PCR assay, with a lower limit of quantitation of 27 IU/mL
Maltese: * Essej ta' PCR għall-HCV-RNA, bil-limitu l-baxx li jista' jiġi kkwantifikat ta' 27 IU/mL
English: Also, refer to peginterferon alfa-2b and interferon alfa-2b SmPCs for adverse reactions that may be attributable to interferons monotherapy.
Maltese: irreferi għall-SmPCs ta' peginterferon alfa-2b u interferon alfa-2b għar-reazzjonijiet avversi li jistgħu jiġu attribwiti għal monoterapija b'interferoni.
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 30 IU/mL), a liver biopsy consistent with a histological diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Maltese: Pazjenti eliġibbli għal dawn il-provi kellhom epatite Ċ kronika ikkonfermata b'analiżi ta' polymerase chain reaction (PCR) pożittiv għall-HCV-RNA (> 30 IU/mL), bijopsija tal-fwied konsistenti ma' dijanjosi istoloġika ta' epatite kronika mingħajr l-ebda kawża oħra għall-epatite kronika u kwantitajiet anormali ta' ALT fis-serum.
English: > 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)
Maltese: > 5 mg/dL (għal > 4 ġimgħat) (tfal u adolexxenti ttrattati b'interferon alfa-2b),
English: 15 mg/kg/day as 2 divided doses (n = 17)
Maltese: 15 mg/kg/jum maqsuma f'2 dożi
English: Vertigo, hearing impaired/loss, tinnitus, ear pain
Maltese: Vertigo, indeboliment/telf ta' smigħ, żanżin fil-widnejn,
English: The mechanism by which Rebetol in combination with other medicinal products exerts its effects against HCV is unknown.
Maltese: Il-mekkaniżmu li bih Rebetol flimkien ma' prodotti mediċinali oħra jeżerċita l-effetti tiegħu kontra HCV mhuwiex magħruf.
English: Discontinue Rebetol if:
Maltese: Waqqaf Rebetol jekk: