FrancophonIA/ELRC3.0 huggingface dataset:
English: P1.5/R Ribavirin (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg) P0.5/R Ribavirin (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg) I/R Ribavirin (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
Maltese: P1.5/R ribavirin (800 mg/) + peginterferon alfa-2b (1.5 mikrogrammi/kg) P0.5/R ribavirin (1,000/1,200 mg) + peginterferon alfa-2b (1.5 sa 0.5 mikrogrammi/kg) I/R ribavirin (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
English: Ribavirin Mylan 200 mg hard capsules ribavirin
Maltese: Ribavirin Mylan 200 mg kapsuli ibsin ribavirin
English: The capsule shell contains gelatine and titanium dioxide (E171).
Maltese: Il-qoxra tal-kapsula fiha gelatine and titanium dioxide (E171).
English: Ribavirin Mylan contains the active substance ribavirin.
Maltese: Ribavirin Mylan fih is-sustanza attiva ribavirin.
English: Alternating doses, 200 mg and 400 mg every other day Less than 30 mL/min 200 mg daily
Maltese: Dożi alternanti, 200 mg u 400 mg kull jumejn Inqas minn 30 mL/min 200 mg kuljum Emodijaliżi (ESRD)
English: Oral formulations of ribavirin monotherapy have been investigated as therapy for chronic hepatitis C in several clinical trials.
Maltese: Formulazzjonijiet orali talmonoterapija ta' ribavirin kienu investigati bħala terapija f'epatite C kronika f'diversi provi kliniċi.
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Maltese: Studju 1 (RIBAVIC; P01017) kien studju multiċentriku randomized li fih ħadu sehem 412 pazjent adult li ma kienux ikkurati qabel, b'epatite C kronika li kellhom ukoll infezzjoni b'HIV.
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) hi simili fl-adulti u fit-tfal jew adolexxenti.
English: Ribavirin (800 mg/day) + interferon alfa2b (3 MIU TIW)
Maltese: Ribavirin (800 mg/jum) + interferon alfa2b (3 MIU TIW)
English: - The active substance is ribavirin 200 mg. - The other ingredients are croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, povidone.
Maltese: - Is-sustanzi l-oħra huma croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, povidone.
English: Ribavirin (800-1,200 mg/da y)d +
Maltese: Ribavirin (8001,200 mg/jum)
English: Overall Responsea (n = 118) Genotype 1 (n = 92)
Maltese: Ġenotip 1 (n = 92)
English: Table 7 Sustained response rates with ribavirin + peginterferon alfa-2b (By ribavirin dose [mg/kg], genotype and viral load) HCV Genotype
Maltese: Rati ta' rispons sostnut b'ribavirin + peginterferon alfa-2b (skont id-doża ta' ribavirin [mg/kg], ġenotip u viral load) Ġenotip HCV
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1,000 to <1/100).
Maltese: Fost ilklassijiet tas-sistemi ta' organi, reazzjonijiet avversi huma elenkati taħt it-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: Ribavirin Mylan 200 mg hard capsules
Maltese: Ribavirin Mylan 200 mg kapsuli ibsin
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 f'assay tal-limfoma tal-ġrieden, u b'doża ta' 20-200 mg/kg f'test tal-mikronukleju tal-ġurdien.
English: • Haemoglobin
Maltese: Emoglobina
English: Thirty two percent (30/94) of subjects demonstrated > 15 percentile decrease in height-for-age percentile 5 years after completion of therapy (see sections 4.8 and 5.1).
Maltese: Tnejn u tletin fil-mija (30/94) tal-individwi wrew tnaqqis ta' > 15 percentile fil-percentile tat-tul skont l-età 5 snin wara t-tlestija tat-terapija (ara sezzjonijiet 4.8 u 5.1).
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: Għall-pazjenti nfettati fl-istess ħin b'HCV/HIV li qed jirċievu ribavirin f'kombinazzjoni ma' peginterferon alfa-2b, effetti avversi oħra (li ma kienux irrappurtati f'pazjenti b'infezzjoni waħda) li kienu rrappurtati fl-istudji bi frekwenza ta' > 5 % kienu: kandidijażi orali (14 %), lipodistrofija akkwiżita (13 %), tnaqqis fil-limfoċiti CD4 (8 %), tnaqqis fl-aptit (8%), żieda tal-gamma glutamyltransferase (9 %), uġigħ fid-dahar (5 %), żieda ta' l-amylase fid-demm (6 %), żieda tal-aċidulattiku fid-demm (5 %), epatite ċitolitika (6 %), żieda tal-lipase (6 %) u uġigħ fir-riġel (6 %).
English: The sustained response at the end of follow-up was significantly increased by the addition of ribavirin capsules to interferon alfa-2b (41% vs 16%, p < 0.001).
Maltese: Ir-rispons sostnut fit-tmiem tal-follow-up żdied b'mod sinifikanti biż-żieda ta' ribavirin kapsuli ma' interferon alfa-2b (41 % vs 16 %, p < 0.001).
English: Three trials examined the use of interferon in naïve patients, two with ribavirin + interferon alfa-2b (C95-132 and I95-143) and one with ribavirin + peginterferon alfa-2b (C/I98-580).
Maltese: Tliet studji eżaminaw l-użu ta' interferon f'pazjenti naive, tnejn b'ribavirin + interferon alfa-2b (C95132 u I95-143) u wieħed b'ribavirin + peginterferon alfa-2b (C/I98-580).
English: Genotype 1* By Week 4*** (n= 950) HCV-RNA negative
Maltese: Ġenotip 1* Ma' Ġimgħa 4*** (n=950)
English: In the treatment phase of this study, the most prevalent adverse reactions in all subjects were pyrexia (80 %), headache (62 %), neutropenia (33 %), fatigue (30 %), anorexia (29 %) and injection-site erythema (29 %).
Maltese: Fil-fażi ta' kura ta' dan l-istudju, l-aktar reazzjonijiet avversi li ħarġu fl-individwi kollha kienu: temperatura għolja (80 %), uġigħ ta' ras (62 %), newtropenija (33 %), għeja (30 %), anoressija (29 %) u ħmura fis-sit ta' l-injezzjoni (29 %).
English: There is a linear relationship between dose and AUCtf following single doses of 200-1,200 mg ribavirin.
Maltese: Hemm relazzjoni linjari bejn id-doża u l-AUCtf wara dożi waħidhom ta' 200-1,200 mg ta' ribavirin.
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 tar-retina*, retinopatiji (inkluża edema makulari)*, sadda ta' l-arterja tar-retina*, sadda tal-vina tarretina*, newrite ottika*, papillo-edema*, telf ta' l-akutezza tal-vista jew tal-medda viżiva*, tnixxijiet mir-retina
English: Psychiatric and Central Nervous System:
Maltese: Sistema Psikjatrika u Sistema Nervuża Ċentrali:
English: Ελλάδα
Maltese: Ġinġivite
English: Therefore, there is a minimal potential for P450 enzyme-based interactions.
Maltese: Għalhekk, hemm probabbilta' minima li jseħħu interazzjonijiet bażati fuq l-enzima P450.
English: Upon discontinuation of dosing the half-life was approximately 298 hours, which probably reflects slow elimination from non-plasma compartments.
Maltese: Wara lwaqfien tad-dożaġġ, il-half-life kienet ta' madwar 298 siegħa, li probabbilment tirrifletti l-eliminazzjoni bil-mod mill-kompartamenti mhux tal-plażma.
English: Pharmacotherapeutic group: antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors, ATC code: J05AB04.
Maltese: Kategorija farmakoterapewtika: antivirali għal użu sistematiku, nuklejosidi u nuklejotidi ħlief limpedituri reverse transciptase, Kodiċi ATC:
English: Generics Pharma Hellas ΕΠΕ Τηλ: +30 210 993 6410
Maltese: Τηλ: +30 210 993 6410
English: Reduce only interferon alfa-2b dose (see note 2) if:
Maltese: Naqqas id-doża ta' interferon alfa-2b biss (ara nota 2) jekk:
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Maltese: Pnewmonja, askarijażi, enterobijasi, herpes zoster, ċellulite Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
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 pazjenti naïve kienu kkurati għal sena b'wieħed minn dawn ilkorsijiet imħallta li ġejjin:
English: 4 capsules b Refer to adult dose recommendations a1 morning, 2 evening 2 morning, 2 evening
Maltese: 4 kapsuli b Irreferi għar-rakkomandazzjonijiet tad-dożaġġ għall-adulti a1 filgħodu, 2 filgħaxija b2 filgħodu, 2 filgħaxija
English: Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Maltese: B'mod globali, madwar 36 % (821/2.286) tal-pazjenti kellhom livelli ta' HCV-RNA fil-plażma li ma setgħux jitkejlu mat-12-il ġimgħa ta' terapija imkejjla permezz ta' test ibbażat fuq riċerka (limitu li seta' jitkejjel 125 IU/ml).
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 98 % [95 % CI: 95 %, 100 %] for paediatric patients treated with interferon alfa-2b and ribavirin.
Maltese: L-istima Kaplan-Meier għar-rispons sostnut li inżamm fuq 5 snin hija ta' 98 % [95 % CI: 95 %, 100 %] għal pazjenti pedjatriċi ikkurati b'interferon alfa-2b u ribavirin.
English: METAVIR Fibrosis Score F2
Maltese: Punteġġ Fibrożi METAVIR
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 (ħemoglobina < 9.4 g/dl) kienet irrappurtata fi 12 % (23/194) talpazjenti kkurati b'ribavirin kapsuli f'kombinazzjoni ma' peginterferon alfa-2b.
English: Hepatotoxicity (including fatalities)*
Maltese: Epatotossiċità (inklużi imwiet)*
English: Very rarely reported side effects (may affect up to 1 in 10,000 people): suicide, stroke (cerebrovascular events).
Maltese: Effetti sekondarji rapportati rarament ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna): suwiċidju, puplesija (każijiet ċerebrovaskulari).
English: Endocrine disorders Common:
Maltese: Disturbi fis-sistema tal-endokrini Komuni:
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b:
Maltese: Terapija doppja b'peginterferon alfa-2b jew interferon alfa-2b:
English: Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Maltese: Infiltrati pulmonari*, pnewmonite*, pnewmonite flinterstizzju*
English: 1 capsule in the morning and 2 capsules in the evening
Maltese: 1 kapsuli filgħodu u 2 kapsuli filgħaxija
English: There were some cases of more severe neutropenia in patients treated with ribavirin capsules 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'ribavirin kapsuli flimkien ma' peginterferon alfa-2b (grad tal-WHO 3: 39 minn 186 [21 %]; u grad 4 tal-WHO: 13 minn 186 [7 %]).
English: A reduction in haemoglobin concentrations by > 4g/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-konċentrazzjonijiet ta' l-emoglobina b'> 4 g/dL kien osservat fi 30 % tal-pazjenti kkurati b'ribavirin u peginterferon alfa-2b u f'37 % tal-pazjenti kkurati b'ribavirin u interferon alfa-2b.
English: Bacterial infection (including sepsis), fungal infection, influenza, respiratory tract infection, bronchitis, herpes simplex, sinusitis, otitis media, rhinitis, urinary tract infection
Maltese: Infezzjoni bil-batteri (inkluża sepsi), infezzjoni bil-fungu, influwenza, infezzjoni tal-passaġġ tan-nifs, bronkite, herpes simplex, sinusite, otitis media, flissjoni, infezzjoni filpassaġġ ta' l-awrina
English: Interferon alfa-2b: No pharmacokinetic interactions were noted between ribavirin and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
Maltese: Interferon alfa-2b: L-ebda interazzjonijiet farmakokinetiċi ma kienu nnotati bejn ribavirin u peginterferon alfa-2b jew interferon alfa-2b fi studju dwar il-farmakokinetika b'dożi multipli.
English: • Psychiatric and central nervous system effects (such as depression, suicidal thoughts, attempted suicide and aggressive behaviour, etc.).
Maltese: • Effetti psikjattriċi u tas-sistema nervuża ċentrali (bħal depressjoni, ħsibijiet ta' suwiċidju, attentat ta' suwiċidju u mġiba aggressiva, eċċ).
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 ta' l-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: Genotype 1
Maltese: Ġenotip 1:
English: p value b
Maltese: B'mod globali
English: Ribavirin Mylan hard capsules
Maltese: Ribavirin Mylan kapsuli ibsin
English: In this subgroup, there was a 92% (89/97) sustained virological response rate.
Maltese: F'dan is-sottogrupp, kien hemm rata ta' 92 % (89/97) li kellhom rispons viroloġiku sostnut.
English: Reduce Ribavirin Mylan dose* if:
Maltese: Naqqas id-doża ta' Ribavirin Mylan* jekk:
English: HCV-RNA negative or ≥ 1 log decrease in viral load
Maltese: HCV-RNA negattiv jew ≥ 1 log tnaqqis fil-viral load
English: Ribavirin Mylan contains lactose
Maltese: Ribavirin Mylan fih il-lactose
English: Other medicines and Ribavirin Mylan
Maltese: Mediċini oħra u Ribavirin Mylan
English: In the cases in which no specific dose recommendation is made, the following dose should be used: Patient weight: < 75 kg = 1,000 mg and > 75 kg = 1,200 mg.
Maltese: Piż tal-pazjent: < 75 kg = 1,000 mg u > 75 kg = 1,200 mg.
English: Combination therapy with ribavirin and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49% vs 5 %, p < 0.0001).
Maltese: Terapija mħallta b'ribavirin + interferon alfa-2b irriżultat f'rispons viroloġiku sostnut li kien għaxar darbiet ogħla minn dak b'interferon alfa-2b waħdu (49 % vs 5 %, p < 0.0001).
English: Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin Mylan (see sections 4.3, 4.4 and 5.3).
Maltese: Għandha tingħata attenzjoni kbira biex it-tqala tkun evitata fis-sieħba ta' pazjenti irġiel li jkunu qed jieħdu Ribavirin Mylan (ara sezzjonijiet 4.3, 4.4 u 5.3).
English: Table 2 Management of Adverse Reactions Laboratory Values
Maltese: Tabella 2 : Immaniġġjar ta' Reazzjonijiet Avversi
English: In clinical trials with ribavirin used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of ribavirin (50 x 200 mg 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'ribavirin użat flimkien ma' peginterferon alfa-2b jew interferon alfa-2b, id-doża eċċessiva massima rrappurtata kienet doża totali ta' 10 g ta' ribavirin (50 kapsula ta' 200 mg) u 39 MIU ta' interferon alfa-2b (13 injezzjonijiet taħt il-ġilda ta' 3 MIU kull waħda) meħuda f'ġurnata waħda minn pazjent f'tentattiv ta' suwiċidju.
English: In clinical trials C95-132 and I95-143, ribavirin + interferon alfa-2b combination therapy proved to be significantly more effective than interferon alfa-2b monotherapy (a doubling in sustained response).
Maltese: Fi studji kliniċi C95-132 u I95-143, it-terapija mħallta ta' ribavirin + interferon alfa-2b intweriet li kienet aktar effettiva b'mod sinifikanti mill-monoterapija ta' interferon alfa-2b (irduppjar fir-rispons sostnut).
English: Each Ribavirin Mylan hard capsule contains 15 mg of lactose monohydrate.
Maltese: Kull kapsula fiha 15 mg lactose.
English: % (number) of patients peginterferon alfa-2b 1.5 µg/kg + Ribavirin peginterferon alfa-2b 1 µg/kg + Ribavirin peginterferon alfa-2a 180 µg + Ribavirin
Maltese: Peginterferon alfa-2b 1 µg/kg + ribavirin peginterferon alfa-2a 180 µg + ribavirin
English: Limited safety data (N = 25) are available in co-infected patients with CD4+ cell counts < 200/µl (see section 4.4).
Maltese: Hemm tagħrif limitat (N = 25) dwar is-sigurtà f'pazjenti li jkollhom infezzjoni fl-istess ħin b'għadd ta' ċelluli CD4+ < 200/µl (ara sezzjoni 4.4).
English: Interferon alfa-2b 3 MIU/m2 3 times a week (n = 54)
Maltese: Interferon alfa-2b 3 MIU/m
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: a: valur-p ibbażat fuq it-test Cochran-Mantel Haenszel Chi square. 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 150 µg/ġimgħa peginterferon alfa-2b . d: dużaġġ ta' ribavirin kien 800 mg għall-pazjenti < 60 kg, 1,000 mg għall-pazjenti 60-75 kg, u 1,200 mg għallpazjenti > 75 kg.
English: Table 10 Predictive Value of In-Treatment Virologic Response while on peginterferon alfa-2b 1.5 µg/kg/ Ribavirin 800-1,400 mg Combination Therapy Negative
Maltese: Tabella 10 Valur Imbassar għar-Rispons Viroloġiku Sostnut Waqt Il-Kura waqt Terapija Kombinata bi peginterferon alfa-2b 1.5 µg/kg/ ribavirin 800-1,400 mg
English: Genotype 1 > 600,000 IU/ml
Maltese: > 600,000 IU/ml
English: Uncommon:
Maltese: Irġiel:
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 ribavirin), and is 99 % (95 % CI: 98-100 %) for patients receiving pegylated interferon alfa-2b (with or without ribavirin).
Maltese: L-istima Kaplan-Meier għal rispons sostnut kontinwu fuq tul ta' 5 snin huwa 97 % (95 % CI: 9599 %) għall-pazjenti li kienu qed jirċievu interferon alfa-2b mhux pegilat (b'ribavirin jew mingħajru), u huwa 99 % (95 % CI: 98-100 %) għall-pazjenti li kienu qed jirċievu interferon alfa-2b pegilat (b' ribavirin jew mingħajru).
English: Female: amenorrhea, menorrhagia, menstrual disorder, dysmenorrhea, breast pain, ovarian disorder, vaginal disorder.
Maltese: Mara: amenorreja, menorraġja, disturbi mestruwali, dismenorreja, uġigħ fis-sider, disturbi fl-ovarji, disturb vaġinali.
English: White opaque body imprinted "riba/200" in green and a white opaque cap imprinted "riba/200" in green.
Maltese: Korp opak abjad li fuqu hemm stampat "riba/200" bl-aħdar u għatu opak abjad li fuqu hemm stampat "riba/200" bl-aħdar.
English: Adult patients with moderate renal impairment (creatinine clearance of 30-50 mL/minute) should be administered alternating daily doses of 200 mg and 400 mg.
Maltese: Pazjenti adulti b'indeboliment tal-kliewi moderat (tneħħija tal-krejatinina ta' 30-50 mL/minuta) għandhom jingħataw dożi ta' kuljum alternanti ta' 200 mg u 400 mg.
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 kkurati b'interferon alfa-2b) jew > 4 mg/dL (għal > 4 ġimgħat) (tfal u adolexxenti kkurati b'peginterferon alfa-2b)
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme* Musculoskeletal and connective tissue disorders Very common:
Maltese: Sindrome ta' Stevens Johnson*, nekroliżi tossika tal-ġilda*,
English: Genotype 1 ≤ 600,000 IU/ml
Maltese:  600,000 IU/ml > 600,000 IU/ml
English: Table 11 Sustained virological response based on genotype after ribavirin in combination with peginterferon alfa-2b in HCV/HIV co-infected patients Study 11
Maltese: Tabella 11 Rispons viroloġiku sostnut ibbażat fuq il-ġenotip wara ribavirin f'kombinazzjoni ma' peginterferon alfa-2b f'pazjenti infettati fl-istess ħin b'HCV/HIV
English: At the peginterferon alfa-2b 1.5 µg/kg plus ribavirin dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/ml and in patients > 40 years old.
Maltese: Bid-doża ta' 1.5 µg/kg peginterferon alfa-2b ma' ribavirin, ir-rati ta' rispons viroloġiku sostnut kienu aktar baxxi f'pazjenti b'ċirrożi, f'pazjenti b'livelli ta' ALT normali, f'pazjenti ta' viral load > 600,000 IU/ml mal-linja bażi, u f'pazjenti li għandhom > 40 sena.
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: Ma' dan, fi studju dwar il-karċinoġeneċità ta' 26 ġimgħa bl-użu tal-mudell heterozygous p53(+/-) tal-ġurdien, ribavirin ma kkawżax tumuri fid-doża massima ttolerata ta' 300 mg/kg (fattur ta' l-espożizzjoni fil-plażma ta' madwar 2.5 meta mqabbel ma' l-espożizzjoni umana).
English: Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa-2b/ribavirin treatment.
Maltese: Għandha tingħata attenzjoni lill-pazjenti pożittivi għall-HIV li huma ko-infettati bl-HCV li qed jirċievu kura bl-impedituri ta' nucleoside reverse transcriptase (NRTI) (l-aktar ddI u d4T) u l-kura assoċjata interferon alfa-2b/ribavirin.
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Maltese: Dejta storika limitata tindika li kura għal 48 ġimgħa tista' tkum marbuta ma' rata ta' rispons sostnut ogħla (11/11) u ma' riskju aktar baxx li jirkadu (0/11 imqabbel ma' 7/96 fl-24 ġimgħa ta' wara l-kura).
English: Vertigo, hearing impaired/loss, tinnitus, ear pain
Maltese: Vertigo, smigħ jiħżien/jintilef, tinnitus, uġigħ fil-widnejn
English: How to store Ribavirin Mylan
Maltese: Tieħux Ribavirin Mylan
English: Ribavirin Mylan must not be used by females who are pregnant (see sections 4.3 and 5.3).
Maltese: Ribavirin Mylan m'għandux jintuża minn nisa waqt it-tqala (ara sezzjonijiet 4.3 u 5.3).
English: Severe adverse reactions were reported in 7 % (8/107) of all subjects and included injection site pain (1 %), pain in extremity (1 %), headache (1 %), neutropenia (1 %), and pyrexia (4 %).
Maltese: Reazzjonijiet avversi severi kienu rrappurtati f'7 % (8/107) ta' l-individwi kollha u kienu jinkludu uġigħ fis-sit ta' l-injezzjoni (1 %), uġigħ fl-estermitajiet (1 %), uġigħ ta' ras (1 %), newtropenija (1 %) u temperatura għolja (4 %).
English: a: Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment, lower limit of detection = 125 IU/ml.
Maltese: a: Rispons għall-kura kien definit bħala HCV-RNA li ma jistax jitkejjel wara 24 ġimgħa wara l-kura, billimitu l-baxx li jista' jitkejjel = 125 IU/ml.
English: Final adult height was available for 14 of those children and show that 12 continued to have height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Maltese: Il-tul finali fl-adulti kien disponibbli għal 14 minn dawk it-tfal u wera li 12 komplew juru tnaqqis fit-tul ta' > 15 percentile, 10 sa 12-il sena wara t-tmiem tal-kura.