FrancophonIA/ELRC3.0 huggingface dataset:
English: Calcium hydrogen phosphate anhydrous Croscarmellose sodium Povidone
Maltese: Il-qalba tal-pillola Calcium hydrogen phosphate anidru Croscarmellose sodium Povidone
English: Seminal transfer of ribavirin has been studied.
Maltese: Kien studjat it-trasferiment seminali ta' ribavirin.
English: Side effects in children and adolescents
Maltese: Effetti sekondarji fi tfal u adolexxenti
English: Immune system disorders
Maltese: Disurbi fis-sistema immuni
English: Teva Pharma Belgium N.V./S.A./AG
Maltese: Teva Pharma Belgium N.V./S.A./AG Tel/Tél:
English: Transfer into seminal fluid
Maltese: Trasferiment fil-fluwidu seminali
English: System Organ Class
Maltese: Klassifika tas-Sistema tal-Organi
English: 3 MIU/m2 3 times a week (n = 54)
Maltese: 3 MIU/m2 3 darbiet fil-ġimgħa (n = 54)
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessut konnettiv
English: Periodontal disorder, dental disorder, tongue pigmentation
Maltese: Disturbi periodontali, disturbi dentali, pigmentazzjoni flilsien
English: Ribavirin Teva Pharma B.V. is available in different pack sizes containing 14, 28, 42, 56, 84, 112, 140 or 168 tablets.
Maltese: Ribavirin Teva Pharma B.V. jiġi f'daqsijiet ta' pakketti differenti ta' 14-il pillola, 28, 42, 56, 84, 112, 140 jew 168 pillola.
English: 15 mg/kg/day as 2 divided doses (n = 17)
Maltese: 15 mg/kg/jum maqsuma f'żewġ dożi (n = 17)
English: • Girl or woman of childbearing age:
Maltese: • Xebba jew mara ta' età li jista' jkollha t-tfal:
English: Ribavirin does not inhibit cytochrome P450 enzymes.
Maltese: Ribavirim ma jimpedixxix l-enżimi ta' cytochrome P450.
English: Cardiac ischaemia*
Maltese: Iskemija kardijaka*
English: Neuralgia, lethargy, psychomotor hyperactivity
Maltese: Newralġja, letarġija, iperattività psikomotorili
English: peginterferon alfa-2b (1.5 µg /kg/ week)
Maltese: peginterferon alfa-2b (1.5 µg /kg/ ġimgħa)
English: For additional details see section 4.5.
Maltese: Għal aktar dettalji ara sezzjoni 4.5.
English: Acute hypersensitivity
Maltese: Sensittività eċċessiva akuta
English: Ribavirin Teva Pharma B.V. contains the active substance ribavirin.
Maltese: Ribavirin Teva Pharma B.V. fih is-sustanza attiva ribavirin.
English: Table 7 Sustained response rates with ribavirin + peginterferon alfa-2b (by ribavirin dose [mg/kg], genotype and viral load)
Maltese: Tabella 7 Rati ta' rispons sostnut b'ribavirin + peginterferon alfa-2b (skont id-doża ta' ribavirin [mg/kg], il-ġenotip u l-viral load)
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
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
English: Genotype 1 ≤ 600,000 IU/mL
Maltese: Ġenotip 1 ≤ 600,000 IU/mL Kollha Ġenotip 1 > 600,000 IU/mL Kollha
English: Sarcoidosis*, rheumatoid arthritis (new or aggravated)
Maltese: Sarkoijdosi*, artrite rewmatojdi (ġdida jew aggravata)
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Ir-Renju Unit
English: Polyvinyl alcohol - partly hydrolysed Macrogol / Polyethylene glycol 3350 Titanium dioxide (E171) Talc
Maltese: Polyvinyl alcohol - parzjalment idrolizzat Macrogol / Polyethylene glycol 3350
English: The pharmacokinetics of ribavirin and interferon alfa-2b (dose-normalized) is similar in adults and children or adolescents.
Maltese: Il-farmakokinetika ta' ribavirin u interferon alfa-2b (doża normalizzata) hija simili fl-adulti jew adoloxxenti.
English: Ribavirin has two pathways of metabolism: 1) a reversible phosphorylation pathway; 2) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxyacid metabolite.
Maltese: Ribavirin għandu żewġ passaġġi ta' metaboliżmu: 1) passaġġ riversibbli ta' fosforilazzjoni; 2) degradazzjoni li tinvolvi t-tneħħija ta' ribose (deribosylation) u idrolisi ta' amidi li tipproduċi metabolit ta' triazole carboxyacid.
English: Aplastic anaemia*
Maltese: Anemija aplastika*
English: Endocrine disorders
Maltese: Disturbi fis-sistema endokrina
English: Bipolar disorder*
Maltese: Disturbi bipolari
English: Less than 30 mL/min
Maltese: Inqas minn 30 mL/min
English: Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Maltese: Emorraġija ċerebrovaskulari*, iskemija ċerebrovaskulari*, enċefalopatija*, polinewropatija*
English: Mitochondrial toxicity
Maltese: Tossiċità mitokondrijali
English: Palpitation, tachycardia
Maltese: Palpitazzjoni, takikardja
English: Male: impotence, prostatitis, erectile dysfunction, Sexual dysfunction (not specified)*
Maltese: Rġiel: impotenza, prostatite, ma jkunx hemm twebbis Nuqqas ta' funzjoni sesswali (mhux speċifikata)*
English: Previously treated adult patients:
Maltese: Pazjenti adulti trattati qabel:
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: Fil-klassifika tas-sistema tal-organi, ir-reazzjonijiet avversi huma elenkati taħt titli ta' frekwenzi bil-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħuf.
English: There were some cases of more severe neutropenia in patients treated with Ribavirin Teva Pharma B.V. 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 ttrattati b'Ribavirin Teva Pharma B.V. flimkien ma' peginterferon alfa-2b (grad 3 tal-WHO: 39 minn 186 [21 %]; u grad 4 talWHO: 13 ta' 186 [7 %]); lewkopenja grad 3 tal-WHO kienet rapportata wkoll f'7 % ta' dan il-grupp ta' trattament.
English: Potential to exacerbate immunosuppression
Maltese: Possibbiltà li taggrava l-immunosoppressjoni
English: Packs of 14, 28, 42, 56, 84, 112, 140 and 168 tablets Not all pack sizes may be marketed.
Maltese: Pakketti f'daqsijiet ta' 14, 28, 42, 56, 84, 112, 140 u 168 kapsul a Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Reduce ribavirin dose* if:
Maltese: Naqqas id-doża ta' ribavirin* jekk:
English: Elderly ( 65 years of age)
Maltese: Anzjani (eta' ta'  65 sena)
English: 1,200 mg/day) d + peginterferon alfa-2b (100 or 150c µg/week)
Maltese: 1,200 mg/jum) d + peginterferon alfa-2b (100 or 150c µg/ġimgħa)
English: 4 x 200 mg tabletsb Refer to adult dose recommendation a: 1 morning, 2 evening b: 2 morning, 2 evening
Maltese: 4 x 200 mg pillolib Irreferi għar-rakkomandazzjonijiet tad-doża fl-adulti a: 1 filgħodu, 2 filgħaxija b: 2 filgħodu, 2 filgħaxija
English: Volume of distribution is approximately 5,000 l. Ribavirin does not bind to plasma proteins.
Maltese: Il-volum ta' distribuzzjoni huwa ta' madwar 5,000 l. Ribavirin ma jintrabatx mal-proteini tal-plażma.
English: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 84 film-coated tablets 112 film-coated tablets 140 film-coated tablets 168 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 42 pillola miksoja b'rita 56 pillola miksija b'rita 84 pillola miksija b'rita 112-il pillola miksija b'rita 140 pillola miksija b'rita 168 pillola miksija b'rita
English: CD4 lymphocytes decrease
Maltese: Tnaqqis fil-limfoċiti CD4
English: Anaemia a (haemoglobin < 9.4 g/dL) was reported in 12 % (23/194) of patients treated with ribavirin in combination with peginterferon alfa-2b.
Maltese: Anemija (emoglobina < 9.4 g/dL) kienet irrappurtata fi 12 % (23/194) tal-pazjenti trattati b'ribavirin f'kombinazzjoni ma' peginterferon alfa-2b.
English: In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and ribavirin 6 % discontinued therapy due to adverse events.
Maltese: Fi provi kliniċi fuq 118-il tifel u tifla u adoloxxent bejn l-etajiet ta' 3 snin sa 16-il sena, ikkurati b'terapija kkombinata ta' interferon alfa-2b u riavirin, 6 % waqqfu t-terapija minħabba reazzjonijiet avversi.
English: Alternating doses, 200 mg and 400 mg every other day
Maltese: Dożi jalternaw, darba 200 mg u darba 400 mg
English: All
Maltese: JIS
English: Ribavirin 15 mg/kg/day interferon alfa-2b 3 MIU/m2 3 times a week
Maltese: Ribavirin 15 mg/kg/jum interferon alfa-2b 3 MIU/m2 3 darbiet fil-ġimgħa
English: MIU = million international units; TIW = three times a week.
Maltese: MIU = miljun unità internazzjonali;
English: Gastro-intestinal disorders
Maltese: Disturbi gastrointestinali
English: Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Maltese: Infiltrati pulmonari*, pnewmonite*, pnewmonite interstizzjali*
English: Adverse Reactions
Maltese: Reazzjonijiet Avversi
English: Retinal haemorrhages*, retinopathies (including macular oedema)*, retinal artery occlusion*, retinal vein occlusion*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, retinal exudates*
Maltese: Emorraġiji retinali*, retinopatiji (li jinkludu edema makulari)*, okklużjoni tal-arterja retinali*, okklużjonitalvina retinali*, newrite ottika*, papilloedema*, tnaqis flakuwita viżwali jew fil-kamp viżwali*, tnixxija retinali*
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excl.reverse transcriptase inhibitors, ATC code: J05AB04.
Maltese: Kategorija farmakoterapewtika: antivirali għall-użu sistematiku, nukleosidi u nukleotidi minbarraimpedituri reverse transcriptase, Kodiċi ATC:
English: Table 3 Management of Adverse Reactions
Maltese: Tabella 3 Immaniġġjar ta' Reazzjonijiet Avversi
English: Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted renally.
Maltese: Kemm ribavirin u l-metaboliti tiegħu triazole carboxamide u triazole carboxylic acid jiġu eliminati permezz tal-kliewi.
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Maltese: Reazzjonijiet avversi imporanti li ħarġu f'din il-popolazzjoni ta' pażjenti kienu nervożità (8 %), aggressjoni (3 %), rabja (2 %), dipressjoni/burdata depressa (4 %) u ipotajrojdiżmu (3 %) u 5 individwi ħadu kura b'levothyroxine għal ipotajrojdiżmu u TSH elevat.
English: Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax=1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Maltese: Ribavirin huwa assorbit malajr wara li jingħata mill-ħalq b'doża waħda (il-medja Tmax= 1.5 sigħat), segwit minn distribuzzjoni mgħaġġla u fażijiet ta' eliminazzjoni mtawwla (half-lives ta' assorbiment b'dożi waħidhom, distribuzzjoni u eliminazzjoni huma 0.05, 3.73 u 79 siegħa, rispettivament).
English: The sustained response at the end of follow-up was significantly increased by the addition of ribavirin to interferon alfa-2b (41 % vs 16 %, p < 0.001).
Maltese: Ir-rispons sostnut fit-tmiem il-follow-up żdied b'mod sinifikanti fiż-żieda ta' ribavirin ma' interferon alfa-2b (41 % vs 16 %, p < 0.001).
English: Cutaneous sarcoidosis
Maltese: Sarkoijdosi kutaneju
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 ribavirin.
English: At the end of 5 years, 85 % (80/94) of all enrolled subjects and 86 % (54/63) of sustained responders completed the study.
Maltese: Fl-aħħar tal-5 snin, 85% (80/94) tal-individwi kollha rreġistrati u 86% (54/63) ta' dawk li kellhom rispons sostnut temmew l-istudju.
English: Ribavirin was active in the Balb/3T3 in vitro transformation assay.
Maltese: Ribavirin kien attiv fl-assaġġ tat-trasformazzjoni tal-Balb/3T3 in vitro.
English: At least 5 years of long-term follow-up was completed after treatment in 462 patients and 327 patients, respectively.
Maltese: Mill-anqas 5 snin ta' follow-up fit-tul intemm wara kura fuq 462 pazjent u 327 pazjent, rispettivament.
English: For HCV/HIV co-infected patients receiving ribavirin in combination with peginterferon alfa-2b, other adverse reactions (that were not reported in mono-infected patients) which have been reported in the studies with a frequency > 5 % were: oral candidiasis (14 %), lipodystrophy acquired (13 %), CD4 lymphocytes decreased (8 %), appetite decreased (8 %), gamma-glutamyltransferase increased (9 %), back pain (5 %), blood amylase increased (6 %), blood lactic acid increased (5 %), cytolytic hepatitis (6 %), lipase increased (6 %) and pain in limb (6 %).
Maltese: Għal pazjenti infettati fl-istess ħin b'HCV/HIV li qed jirċievu ribavirin f'kombinazzjoni ma' peginterferon alfa-2b, reazzjonijiet avversi oħra (li ma kienux irrappurtati f'pazjenti b'infezzjoni waħda) li kienu rrappurtati fl-istudji bi frekwenza > 5 % kienu: kandidijażi orali (14 %), lipodistrofija akkwiżita (13 %), tnaqqis fil-linfoċiti CD4 (8 %), tnaqqis fl-aptit (8 %), żieda fil-gamma-glutamyltransferase i (9 %), uġigħ fid-dahar (5 %), żieda tal-amylase fid-demm (6 %), żieda fl-aċidu lattiku fid-demm (5 %), epatite ċitolitika (6 %), żieda fil-lipase (6 %) u uġigħ firriġel/driegħ (6 %).
English: Laguno M, Murillas J, Blanco J.L et al. AIDS 2004; 18(13): F27-F36.
Maltese: AIDS 2004; 18(13): F27-F36.
English: - had a serious heart problem during the past 6 months
Maltese: - kellek problema serja bil-qalb fl-aħħar 6 xhur
English: Suicide*
Maltese: Suwiċidju*
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: Additionally, 98 % (51/52) with normal ALT levels at follow-up week 24 maintained normal ALT levels at their last visit.
Maltese: Barra minn hekk, 98 % (51/52) b'livelli normali ta' ALT fil-ġimgħa 24 ta' follow-up żammew livelli normali ta' manteniment ta' ALT fl-aħħar viżta tagħhom.
English: Haemolitic anaemia, leukopenia, thrombocytopenia, lymphadenopathy, lymphopenia
Maltese: Anemija emolitika, lewkopenija, tromboċitopenija, limfadenopatija, limfopenja
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 ta' kombinazzjoni b'ribavirin u 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: 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 inkonsapevoli kien ittrattat għal sena waħda b'wieħed minn dawn il-programmi ta' kombinazzjoni li ġejjin:
English: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Maltese: Nisa: amenorrea, menorraġja, disturbi menstruwali, disturbi vaġinali
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: Fil-provi kliniċi C95-132 u I95-143, it-terapija bil-kombinazzjoni ribavirin + interferon alfa-2b intweriet li kienet aktar effettiva mill-monoterapija b'interferon alfa-2b (irdoppjar fir-rispons sostnut).
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 ta' Kaplan-Meier għat-tkomplija ta' rispons sostnut fuq 5 snin hi ta' 98 % [95 % CI: 95 %, 100 %] għal pazjenti pedjatriċi kkurati b'interferon alfa-2b u ribavirin.
English: Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Maltese: Sindromu Vogt-Koyanagi-Harada, lupus eritematosi sistemiku, artrite rewmatojdi (ġdida jew aggravata), vaskulite, reazzjonijiet ta' sensittività eċċessiva li jinkludu urikarja, anġjodema, tidjieq tal-bronki, anafilassi
English: Table 2 Management of Adverse Reactions Laboratory values
Maltese: Tabella 2 Immaniġġjar ta' Reazzjonijiet Avversi Valuri tal-laboratorju
English: Ribavirin Teva Pharma B.V. 400 mg Tablets *Nb: for 800 mg daily dose, 2 x 200 mg tablets can be substituted for 1 x 400 mg tablet.
Maltese: Ribavirin Teva Pharma B.V. 400 mg Pilloli *Nb: għal dożi ta' kuljum ta' 800 mg, 2 x 200 mg jistgħu jiġu sostitwiti b'pillola 1 x 400 mg
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 prevalenti fl-individwi kollha kienu ddeni (80%), uġigħ ta' ras (62%), newtropenija (33 %), għeja (30 %), anoreksja (29 %) u eritema fis-sit tal-injezzjoni (29 %).
English: Haematological abnormalities in HCV/HIV co-infected patients:
Maltese: Abnormalitajiet ematoloġiċi f'pazjenti infettati b'HCV/HIV fl-istess ħin:
English: Teva Pharma SLU
Maltese: Teva Pharma
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis
Maltese: Pnewmonja, askarjasi, enterbijasi, herpes zoster, ċellulite
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Maltese: Din lattività tista' twassal għal riskju akbar ta' aċidożi lattika kkaġunata minn analogi ta' nucleoside talpurina (eż. didanosine jew abacavir).
English: There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa.
Maltese: Hemm diversi reazzjonijiet avversi serji assoċjati mat-terapija ta' ribavirin flimkien ma' (peg)interferon alfa.
English: • are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
Maltese: • intom nisa ta' età li jista' jkollkom it-tfal (ara s-sezzjoni, “Tqala u treddigħ”).
English: Pneumonia*
Maltese: Pnewmonja*
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Maltese: Arritmiji kardijaċi (prinċipalment supraventrikulari) ġeneralment jirrispondu għal terapija konvenzjonali imma għandu mnejn ikun hemm bżonn li titwaqqaf it-terapija.
English: Ribavirin (800 mg/day) + interferon alfa2b (3 MIU TIW)
Maltese: Ribavirin (800 mg/jum) + interferon alfa-2b (3 MIU TIW)
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 u każwali li fih ħadu sehem 412-il pazjent arwolat li ma kinux ġew ittrattati qabel għal epatite Ċ u li kellhom ukoll infezzjoni b'HIV.
English: Hypertriglyceridemia, hyperuricemia
Maltese: Ipertrigliċeridemja, iperurikemija
English: A reduction in haemoglobin concentrations by > 4 g/dL was observed in 30 % of patients treated with ribavirin and peginterferon alfa-2b and 37 % of patients treated with ribavirin and interferon alfa-2b.
Maltese: Tnaqqis fil-konċentrazzjoni ta' emoglobulina b' > 4 g/dL kien osservat fi 30 % tal-pazjenti trattati b' ribavirin u peginterferon alfa-2b u 37 % tal-pazjenti trattati b'ribavirin + interferon alfa-2b.
English: Ribavirin Teva Pharma B.V. 200 mg film-coated tablets are light-pink to pink, (debossed with “93” on one side and “7232” on the other).
Maltese: Ribavirin Teva Pharma B.V. 200 mg huma pilloli miksija b'rita ta' lewn roża ċar għal roża, (intaljati b'”93 fuq naħa waħda u “7232” fuq in-naħa l-oħra).
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), jew > 4 mg/dL (għal > 4 ġimgħat) (tfal u adolexxenti ttrattati b'peginterferon alfa-2b)
English: Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Maltese: Attività ġenotossika kienet osservata fl-assaġġ tal-limfoma tal-ġrieden, u b'dożi ta' 20-200 mg/kg f'assaġġ tal-mikronukleju tal-ġrieden.
English: Peripheral ischaemia*
Maltese: Iskemija periferali*
English: Reproductive system and breast disorders
Maltese: Disturbi fis-sistema riproduttiva u tas-sider
English: For laboratory monitoring of pregnancy, please refer to Laboratory tests.
Maltese: Għal monitoraġġ tat-tqala tal-laboratorju, jekk jogħġbok irreferi għal Testijiet tal-laboratorju.
English: suicide, stroke (cerebrovascular events).
Maltese: - suwiċidju - puplesija (episodji ċerebrovaskulari).
English: Table 8 Sustained virological response based on genotype after ribavirin in combination with peginterferon alfa-2b in HCV/HIV co-infected patients
Maltese: Tabella 8 Rispons viroloġiku sostnut skont il-ġenotip wara ribavirin ingħata flimkien ma' peginterferon alfa-2b f'pazjenti infettati fl-istess ħin b'HCV/HIV
English: Alopecia, pruritus, skin dry, rash
Maltese: Alopeċja, ħakk, ġilda xotta, raxx
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: Fi ħdan il-kategorija tas-sistema tal-organi, reazzjonijiet avversi huma elenkati taħt titli ta' frekwenza permezz tal-kategoriji li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10), u mhux komuni (≥ 1/1,000 sa < 1/100).
English: Outer Carton for 14, 28, 42, 56, 84, 112, 140 and 168 film-coated tablets
Maltese: Kartuna ta' Barra għal 14, 28, 42, 56, 84, 112, 140, 168 pillola miksija b'rita
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 rapportati f'7 % (8/107) tal-individwi kollha u kienu jinkludu uġigħ fis-sit fejn ingħatat l-injezzjoni (1 %), uġigħ fl-estremità (1 %), uġigħ ta' ras (1 %), newtropenija (1 %), u deni ( 4 %).
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: Enuresis, micturition disorder, urinary incontinence, proteinuria
Maltese: Enuresi, disturbi biex tgħaddi l-awrina, inkontinenza flawrina, proteinurja
English: Tabulated list of adverse reactions for adults
Maltese: Lista ta' reazzjonijiet avversi fl-adulti miġbura f'tabella
English: This medicine stops the multiplication of many types of viruses, including hepatitis C virus.
Maltese: Din il-mediċina twaqqaf ilmultiplikazzjoni ta' ħafna tipi ta' virusis, li jinkludu l-virus ta' epatite Ċ.
English: Renal failure*, renal insufficiency*
Maltese: Indeboliment renali*, insuffiċjenza tal-kliewi*