FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with interferon alfa-2a resulted in a statistically significant increase in abortifacient activity in rhesus monkeys.
Maltese: Il-kura b'interferon alfa-2a irriżultat f'żieda statistikament sinifikanti fin-numru ta' aborti fix-xadini rhesus.
English: The following may be considered as baseline values for initiation of treatment: - Platelet count ≥ 90,000 cells/mm3 - ANC ≥ 1500 cells/mm3
Maltese: - Għadd ta' plejtlits ≥ 90,000 ċellula/mm3 - ANC ≥ 1500 ċellula/mm3
English: Ribavirin dose
Maltese: Doża ta' Ribavirin Tul
English: Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/lactic acidosis have been reported with use of ribavirin.
Maltese: Rapporti ta' insuffiċjenza epatika fatali kif ukoll newropatija periferali, pankreatite, u iperlaktejtimja sintomatika/aċidożi lattika kienu rrappurtati bl-użu ta' ribavirin.
English: Ribavirin, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-methylthioinosine monophosphate (6-MTIMP), which has been associated with myelotoxicity in patients treated with azathioprine.
Maltese: Permezz ta' effett inibitorju fuq inosine monophosphate dehydrogenase, ribavirin jista' jinterferixxi mal-metaboliżmu ta' azathioprine u possibbilment iwassal għall-akkumulazzjoni ta' 6methylthioinosine monophosphate (6-MTIMP), li kienet assoċjata ma' majelotossiċità f'pazjenti kkurati b'azathioprine.
English: 2 years.
Maltese: 3 snin.
English: Decrease in ANC levels below 500 cells/mm3 was observed in 13% and 11% of patients receiving Pegasys monotherapy and combination therapy, respectively.
Maltese: Tnaqqis fillivelli ta' ANC taħt 500 ċellula/mm3 kien osservat fi 13% u fi 11% tal-pazjenti li rċevew Pegasys waħdu jew f'terapija kombinata, rispettivament.
English: Hyperglycaemia, type 1 diabetes mellitus
Maltese: ipergliċemija, dijabete mellitus tip 1, u anemija).
English: During treatment, co-infected patients should be closely monitored for signs and symptoms of hepatic decompensation (including ascites, encephalopathy, variceal bleeding, impaired hepatic synthetic function; e.g., Child-Pugh score of 7 or greater).
Maltese: Waqt il-kura, pazjenti ko-infettati għandhom jiġu ssorveljati bir-reqqa għal sinjali u sintomi ta' dekompensazzjoni tal-fwied (inkluż axxite, enċefalopatija, fsada variċeali, funzjoni sintetika tal-fwied indebolita; eż., punteġġ Child-Pugh ta' 7 jew akbar).
English: Dose adjustement in paediatric patients - dual therapy with Pegasys and ribavirin
Maltese: Tul tal-kura - terapija ta' żewġ mediċini b'Pegasys u ribavirin
English: The probabilities of not achieving a sustained virological response with 48 or 72 weeks of treatment if viral suppression was not achieved at week 12 were 96% (363 of 380) and 96% (324 of 339), respectively.
Maltese: Il-probabbiltajiet li ma jintlaħaqx rispons viroloġiku sostenut b'48 jew 72 ġimgħa ta' kura jekk sopressjoni virali ma nlaħqitx f'ġimgħa 12 kienu ta' 96% (363 minn 380) u 96% (324 minn 339), rispettivament.
English: In the paediatric study, the most prevalent adverse reactions in patients treated with combination therapy for up to 48 weeks with Pegasys and ribavirin were influenza-like illness (91%), headache (64%), gastrointestinal disorder (56%), and injection-site reaction (45%).
Maltese: Fl-istudju pedjatriku, l-aktar reazzjonijiet avversi komuni f'pazjenti kkurati b'terapija kombinata ta' Pegasys u ribavirin għal perjodu sa 48 ġimgħa kienu marda li tixbaħ lill-influwenza (91%), uġigħ ta' ras (64%), disturb gastrointestinali (56%), u reazzjoni fis-sit tal-injezzjoni (45%).
English: Roche Pharma AG Emil-Barell-Str.1
Maltese: Emil-Barell-Str.1
English: Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Maltese: Terapija Anti-Retrovirali Attiva Ħafna (HAART - Highly Active Anti-Retroviral Therapy), li hi kura għall-HIV.
English: Discontinue combination
Maltese: Waqqaf itterapaija kombinata
English: TSH levels should be determined during the course of therapy if a patient develops clinical symptoms consistent with possible thyroid dysfunction (see section 4.8).
Maltese: Il-livelli ta' TSH għandhom jiġu determinati matul it-terapija jekk pazjent jiżviluppa sintomi kliniċi konsistenti ma' possibbiltà ta' disfunzjoni tattirojde (ara sezzjoni 4.8).
English: In the same study, a 25% increase in the AUC of theophylline (marker of cytochrome P450 1A2 activity) was observed, demonstrating that Pegasys is an inhibitor of cytochrome P450 1A2 activity.
Maltese: Fl-istess studju, kienet osservata żieda ta' 25% fl-AUC ta' theophylline (markatur tal-attivita' taċċitokromju P450 1A2), li turi li Pegasys huwa impeditur tal-attività taċ-ċitokromju P450 1A2.
English: Roche
Maltese: France Roche
English: For persistent ALT values ≥10 x ULN discontinue treatment.
Maltese: Għal valuri persistenti ta' ALT ta' ≥10 x ULN waqqaf it-trattament għal kollox.
English: Genotype 2 or 3 RVR Low viral load High viral load
Maltese: Ġenotip 2/3 Viral load baxxa
English: Pulmonary changes
Maltese: emboliżmu pulmonari
English: A total of 55 patients received initial combination treatment of Pegasys plus ribavirin, of whom 51% were female, 82% were Caucasian, and 82% were infected with HCV genotype 1.
Maltese: Total ta' 55 pazjent irċevew kura kombinata tal-bidu ta' Pegasys flimkien ma' ribavirin, li fosthom 51% kienu nisa, 82% kienu Kawkażi, u 82% kienu infettati b'HCV ġenotip 1.
English: In a clinical trial (YV25718) with 111 paediatric patients (3 to 17 years of age) treated with Pegasys for 48 weeks, the safety profile was consistent with that seen in adults with CHB and in paediatric patients with CHC.
Maltese: Fi prova klinika (YV25718) b'111-il pazjent pedjatriku (età minn 3 snin sa 17-il sena) ittrattati b'Pegasys għal 48 ġimgħa, il-profil ta' sigurtà kien konsistenti ma' dak osservat f'adulti b'CHB u f'pazjenti pedjatriċi b'CHC.
English: Progressive decreases after 8 weeks of therapy were infrequent.
Maltese: Tnaqqis li kompla wara 8 ġimgħat ta' terapija ma kienx frekwenti.
English: The frequencies observed (4.9%) in patients receiving Pegasys/ribavirin (NV15801) are similar to those observed with other interferons.
Maltese: Il-frekwenzi osservati (4.9%) f'pazjenti li kienu qed jirċievu Pegasys/ribavirin (NV15801) huma simili għal dawk osservati b'interferoni oħrajn.
English: Fever/infections
Maltese: Deni/infezzjonijiet
English: < 250 cells/mm3 (or febrile neutropenia): discontinue treatment.
Maltese: < 250 ċellula/mm3 (jew newtropenija bid-deni): waqqaf it-trattament għal kollox.
English: Undesirable effects reported in clinical studies are grouped according to frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Maltese: Effetti mhux mixtieqa rrappurtati fi studji kliniċi huma miġbura skont il-frekwenza kif ġej: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1000), rari ħafna (< 1/10,000).
English: The peak to trough ratio after 48 weeks of treatment is about 1.5 to 2.
Maltese: Ilproporzjon bejn il-massimu u l-minimu wara 48 ġimgħa ta' kura huwa ta' madwar 1.5 sa 2.
English: Pegasys 135 micrograms solution for injection in pre-filled syringe EU/1/02/221/005
Maltese: Pegasys 135 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/02/221/005
English: Table 21: Sustained virological response based on genotype and pre-treatment viral load after Pegasys combination therapy with ribavirin in HIV-HCV co-infected patients Study NR15961 Interferon alfa-2a 3 MIU
Maltese: Rispons viroloġiku sostenut ibbażat fuq il-ġenotip u l-viral load ta' qabel il-kura wara terapija kombinata ta' Pegasys ma' ribavirin f'pazjenti ko-infettati b'HIV-HCV Studju NR15961 Interferon alfa-2a
English: Table 1: Dosing recommendations for combination therapy for adult patients with chronic hepatitis C
Maltese: Tabella 1: Dożaġġi rakkomandati għal terapija kombinata għall-pazjenti adulti b'epatite Ċ
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.2 and 5.1.
Maltese: Għall-attività speċifika għall-ġenotip tal-virus tal-epatite Ċ (HCV - hepatitis C virus), ara sezzjonijiet 4.2 u 5
English: Withhold Pegasys
Maltese: Waqqaf Pegasys
English: <750 cells/mm3), and thrombocytopenia (13% experienced a platelet count <50,000 cells/mm3) (see section 4.4).
Maltese: ANC <750 ċellula/mm3), u tromboċitopenija (13% kellhom għadd tal-plejtlits <50,000 ċellula/mm3)
English: Pegasys 180 mcg Ribavirin 1000/1200 mg 24 weeks
Maltese: Pegasys 180 mcg & ribavirin 1000/1200 mg, 24 ġ:
English: • Hypersensitivity to the active substance, to alfa interferons, or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva, għall-alfa interferons, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: The terminal half-life after subcutaneous administration in patients is longer with a mean value of 160 hours (84 to 353 hours).
Maltese: Il-half life terminali hija itwal wara li jingħata minn taħt il-ġilda b'valur medju ta' 160 siegħa (84 sa 353 siegħa).
English: Depression, anxiety, hallucination, abnormal behaviour, aggression, anger, attention deficit / hyperactivity disorder
Maltese: alluċinazzjonijiet, mġiba mhux normali, aggressjoni, rabja, disturb ta' nuqqas ta' attenzjoni/attività żejda
English: Laboratory tests prior to and during therapy
Maltese: Testijiet tal-laboratorju ta' qabel u ta' waqt it-terapija
English: No apparent evidence of drug interaction was observed in 47 HIV-HCV co-infected patients who completed a 12-week pharmacokinetic substudy to examine the effect of ribavirin on the intracellular phosphorylation of some nucleoside reverse transcriptase inhibitors (lamivudine and zidovudine or stavudine).
Maltese: Ma kienet osservata l-ebda evidenza apparenti ta' interazzjoni ta' mediċini f'47 pazjent ko-infettati b'HIV-HCV li temmew substudju farmakokinetiku ta' 12-il ġimgħa li eżamina l-effett ta' ribavirin fuq il-fosforilizazzjoni intraċellulari ta' uħud mill-inibituri ta' nucleoside reverse transcriptase (lamivudine u zidovudine jew stavudine).
English: Interferon alfa-2b 3 MIU
Maltese: Interferon alfa-2b
English: Table 25: Sustained virological response in the NV17424 study Pegasys 180 mcg x BSA/1.73 m² + Ribavirin 15 mg/kg (N=55)*
Maltese: Pegasys 180 mcg x BSA/1.73 m² + Ribavirin 15 mg/kg (N=55)*
English: The mean exposure (AUC) during the dosing interval is predicted to be 25% to 70% higher than that observed in adults receiving 180 mcg fixed dosing.
Maltese: L-esponiment medju (AUC) matul l-intervall ta' dożaġġ huwa mbassar bħala 25% sa 70% ogħla minn dak osservat f'adulti li jirċievu 180 mcg ta' dożaġġ fiss.
English: Pegasys 180 micrograms solution for injection in pre-filled syringe EU/1/02/221/007
Maltese: Pegasys 180 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/02/221/007
English: Administration of Pegasys 180 micrograms once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that Pegasys has no effect on in vivo metabolic activity of cytochrome P450 3A4, 2C9, 2C19 and 2D6 isozymes.
Maltese: Għoti ta' Pegasys 180 mikrogramma darba fil-ġimgħa għal 4 ġimgħat f'irġiel f'saħħithom ma wera lebda effett fuq il-profili farmakokinetiċi ta' mephenytoin, dapsone, debrisoquine u tolbutamide, li jissuġġerixxi li Pegasys m'għandu l-ebda effett fuq l-attività metabolika in vivo tal-isożimi 3A4, 2C9, 2C19 u 2D6 taċ-ċitokromju P450.
English: Pegasys has not been evaluated in patients with decompensated cirrhosis (e.g., Child-Pugh B or C or bleeding oesophageal varices) (see section 4.3).
Maltese: Pegasys ma ġiex evalwat f'pazjenti b'ċirrożi dekompensata (eż., Child-Pugh B jew Ċ jew variċi tal esofagu li jinfasdu (ara sezzjoni 4.3).
English: ● The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic acid and water for injections.
Maltese: • Is-sustanzi l-oħra huma sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic acid u ilma għall-injezzjonijiet.
English: Genotype 1 LVL with RVR*
Maltese: Ġenotip 1 LVL b'RVR*
English: 1000 mg/day
Maltese: 1000 mg/jum
English: • HIV-HCV patients with cirrhosis and a Child-Pugh score ≥ 6, except if only due to indirect hyperbilirubinemia caused by medicinal products such as atazanavir and indinavir
Maltese: • Pazjenti b'HIV-HCV li għandhom ċirrożi u punteġġ Child-Pugh ta' ≥ 6, minbarra jekk ikkawżat biss minn iperbilirubinimja indiretta ikkawżata minn prodotti mediċinali bħal atazanavir u indinavir
English: In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
Maltese: F'terapija kombinata ma' ribavirin, ara l-fuljetti ta' tagħrif rispettivi tal-prodotti mediċinali li fihom ribavirin.
English: Exposure to didanosine or its active metabolite (dideoxyadenosine 5'-triphosphate) is increased in vitro when didanosine is coadministered with ribavirin.
Maltese: L-espożizzjoni għal didanosine jew għall-metabolit attiv tiegħu (dideoxyadenosine 5'-triphosphate) tiżdied in vitro meta didanosine jingħata flimkien ma' ribavirin.
English: Thrombocyto penia, anaemia, lymphadenop athy
Maltese: Tromboċitopen ija, anemija, limfoadenopatija
English: The interaction between theophylline and Pegasys is likely to be maximal after more than 4 weeks of Pegasys therapy.
Maltese: L-interazzjoni bejn theophylline u Pegasys huwa probabli li tkun l-ogħla wara aktar minn 4 ġimgħat ta' terapija b'Pegasys.
English: The probability for sustained virological response varied depending upon the previous treatment regimen; see Table 20.
Maltese: Il-probabbiltà ta' rispons viroloġiku sostenut varjat skont il-kors tal-kura ta' qabel; ara Tabella 20.
English: Pegasys injection is normally taken at bedtime.
Maltese: Pegasys normalment jintuża waħdu.
English: * For HBeAg-positive patients: HBV DNA < 105 copies/ml For HBeAg-negative/anti-HBe-positive patients: HBV DNA < 2 x 104 copies/ml
Maltese: DNA ta' HBV < 105 kopji/ml Għall-pazjenti negattivi għal HBeAg/pożittivi għal anti-HBe:
English: Duration of treatment - dual therapy with Pegasys and ribavirin The duration of combination therapy with ribavirin for CHC depends on viral genotype.
Maltese: Tul tal-kura - terapija ta' żewġ mediċini b'Pegasys u ribavirin It-tul ta' terapija kombinata ma' ribavirin għal CHC tiddependi fuq il-ġenotip tal-virus.
English: Mania, bipolar disorders, homicidal ideation
Maltese: Manija, disturbi bipolari,
English: Serious infections (bacterial, viral, fungal) and sepsis have been reported during treatment with alfa interferons including Pegasys.
Maltese: Infezzjonijiet serji (ikkawżati minn batterja, virus, jew moffa) u sepsi kienu rrappurtati waqt kura b'alfa interferons inkluż Pegasys.
English: Consideration should be given to replacing zidovudine in a combination anti-retroviral therapy regimen if this is already established.
Maltese: Għandha tingħata konsiderazzjoni għas-sostituzzjoni ta' zidovudine f'kors ta' terapija anti-retrovirali kombinata jekk din tkun diġà stabbilita.
English: For HCV monoinfected patients and HIV-HCV co-infected patients, for treatment regimens, duration of therapy and study outcome see Tables 13, 14, 15 and Table 21, respectively.
Maltese: F'pazjenti infettati biss b'HCV u pazjenti ko-infettati b'HIV-HCV, għall-korsijiet ta' kura, tul tat terapija u riżultat tal-istudju ara Tabelli 13, 14, 15 u Tabella 21, rispettivament.
English: Weekly doses of up to 540 and 630 micrograms have been administered in renal cell carcinoma and chronic myelogenous leukaemia clinical trials, respectively.
Maltese: Dożi sa 540 u 630 mikrogramma fil-ġimgħa kienu mogħtija fi provi kliniċi f'każijiet ta' karċinoma taċ-ċelluli renali u lewkimja majeloġenika kronika, rispettivament.
English: D-79639 Grenzach- Wyhlen Germany
Maltese: D-79639 Grenzach- Wyhlen Il-Ġermanja
English: Pegasys is contraindicated in neonates and young children up to 3 years old due to the excipient benzyl alcohol (see sections 4.3 and 4.4).
Maltese: Pegasys huwa kontraindikat fi trabi tat-twelid u tfal żgħar b'età sa 3 snin minħabba l-eċċipjent benzyl alcohol (ara sezzjonijiet 4.3 u 4.4).
English: ≥2 log10 decline
Maltese: log10
English: Bronchitis, upper respiratory infection, oral candidiasis, herpes simplex, fungal, viral and bacterial infections
Maltese: Bronkite, infezzjoni tassistema respiratorja ta' fuq, kandidjażi fil-ħalq, herpes simplex, infezzjonijiet mill-moffa, virali u millbatterja
English: Pulmonary symptoms, including dyspnoea, pulmonary infiltrates, pneumonia, and pneumonitis have been reported during therapy with Pegasys.
Maltese: Tibdil pulmonari Sintomi pulmonari, li jinkludu qtugħ ta' nifs, infiltrati pulmonari, pnewmonja, u pulmonite kienu rrappurtati waqt terapija b'Pegasys.
English: Sustained response
Maltese: Rispons sostenut
English: Myositis
Maltese: Mijosite
English: 2 level reduction (mcg)
Maltese: Tnaqqis ta' żewġ livelli (mcg)
English: Genotype 1 HVL with RVR*
Maltese: Ġenotip 1 HVL b'RVR*
English: In a clinical trial of non-responder patients to prior pegylated interferon alfa-2b/ribavirin, which exposed patients to either 48 or 72 weeks of treatment, the frequency of withdrawal for adverse events or laboratory abnormalities from Pegasys treatment and ribavirin treatment was 6% and 7%, respectively, in the 48 week arms and 12% and 13% ,respectively, in the 72 week arms.
Maltese: Fi prova klinika ta' pazjenti li ma rrispondewx għal interferon alfa-2b pegilat/ribavirin mogħti qabel, li esponiet il-pazjenti għal 48 jew 72 ġimgħa ta' kura, il-frekwenza ta' waqfien minħabba avvenimenti avversi jew anormalitajiet tal-laboratorju kkawżati minn kura ta' Pegasys u kura ta' ribavirin kienet ta' 6% u 7% rispettivament, fil-gruppi ta' 48 ġimgħa u 12% u 13% rispettivament, fil-gruppi ta' 72 ġimgħa.
English: 24 weeks
Maltese: Tabella 24:
English: High viral load = > 800,000 IU/ml, low viral load = ≤ 800,000 IU/ml.
Maltese: IU/ml, viral load baxxa = ≤ 800,000
English: Early virological response by week 12, defined as a 2 log viral load decrease or undetectable levels of HCV RNA has been shown to be predictive for sustained response (see Tables 2 and 13).
Maltese: Rispons viroloġiku bikri sa ġimgħa 12, definit bħala tnaqqis ta' 2 log fil-viral load jew livelli ta' RNA ta' HCV li ma jitkejlux kien muri bħala indikattiv għal rispons sostenut (ara Tabelli 2 u 13).
English: 600 mg/day
Maltese: 600 mg/jum
English: HBeAg Seroconversion
Maltese: Serokonverżj oni ta' HBeAg
English: Pegasys 180 mcg Ribavirin 800 mg 24 weeks
Maltese: Pegasys 180 mcg Ribavirin 800 mg 24 ġimgħa
English: Do not shake.
Maltese: Rifjut ta'
English: Haematologic laboratory abnormalities observed during the first 20 weeks of the trial included anaemia (26% of patients experienced a haemoglobin level of <10 g/dl), neutropenia (30% experienced an ANC
Maltese: Anormalitajiet ematoloġiċi tal-laboratorju osservati waqt l-ewwel 20 ġimgħa tal-prova kienu jinkludu anemija (26% tal-pazjenti kellhom livell tal-emoglobina ta' <10 g/dl), newtropenija (30% kellhom
English: 180 micrograms
Maltese: 180 mcg
English: Detailed instructions are provided at the end of this leaflet (see “How to inject Pegasys”).
Maltese: Istruzzjonijiet dettaljati huma pprovduti fl-aħħar ta' dan il-fuljett (ara “Kif tinjetta Pegasys”).
English: Patients who still have detectable levels of HCV-RNA despite an initial 24 weeks of therapy, should discontinue therapy, as it is unlikely they will be able to achieve a sustained virological response with continued therapy.
Maltese: Pazjenti li għad għandhom livelli traċċabbli ta' RNA ta' HCV minkejja 24 ġimgħa ta' terapija inizjali, għandhom iwaqqfu t-terapija, peress li mhux probabbli li se jkunu kapaċi jilħqu rispons viroloġiku sostenut b'terapija kontinwa.
English: Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorders, mania, confusion and alterations of mental status have been observed with alfa interferons.
Maltese: Effetti oħra tas-CNS inkluż imġieba aggressiva (xi kultant immirata lejn oħrajn bħal ħsibijiet ta' omiċidju), disturbi bipolari, manija, konfużjoni u tibdil fl-istat mentali kienu osservati b'alfa interferons.
English: Peginterferon alfa-2a is found predominantly in the bloodstream and extracellular fluid as seen by the volume of distribution at steady-state (Vd) of 6 to 14 litres in humans after intravenous administration.
Maltese: Peginterferon alfa-2a jinstab l-aktar fid-demm u fil-fluwidu extraċellulari kif jidher mill-volum ta'distribuzzjoni fi stat fiss (Vd) ta' 6 sa 14-il litru fil-bnedmin wara li jingħata fil-vini.
English: Pegasys is used to treat chronic hepatitis B or chronic hepatitis C in adults.
Maltese: Pegasys jintuża biex jikkura epatite B kronika jew epatite Ċ kronika fl adulti.
English: Pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis C (CHC) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1).
Maltese: Pegasys huwa indikat flimkien ma' prodotti mediċinali oħra għall-kura ta' epatite Ċ kronika (CHCchronic hepatitis C) f'pazjenti b'mard kumpensat tal-fwied (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: The strength indicates the quantity of the interferon alfa-2a moiety of peginterferon alfa-2a without consideration of the pegylation.
Maltese: Il-qawwa tindika l-kwantità tal-parti ta' interferon alfa-2a ta' peginterferon alfa-2a mingħajr konsiderazzjoni tal-pegilazzjoni.
English: Genotype 2 or 3 LVL with RVR**
Maltese: Ġenotip 2 jew 3 LVL b'RVR**
English: Ribavirin number of tablets
Maltese: Numru ta' pilloli ta' ribavirin
English: Interferon alfa-2b 3 MIU Ribavirin mg (N=444) 48 weeks
Maltese: Interferon alfa-2a 3 MIU & ribavirin 800mg:
English: The AUC was slightly increased (1663 vs. 1295 ng·h/ml) but peak concentrations (9.1 vs. 10.3 ng/ml) were similar in subjects older than 62 years.
Maltese: L-AUC kienet kemmxejn ogħla (1663 vs. 1295 ng.h/ml) iżda l-konċentrazzjonijiet massimi (9.1 vs. 10.3 ng/ml) kienu simili f'individwi li għandhom aktar minn 62 sena.
English: 4 pre-filled syringes + 4 injection needles 135 micrograms/0.5 ml
Maltese: 4 siringi mimlija għal-lest + 4 labar għall-injezzjoni 135 mikrogramma/0.5 ml
English: Use of peginterferon as long term maintenance monotherapy (unapproved use) In a randomised, controlled US study (HALT-C) of HCV non-responder patients with varied degrees of fibrosis where 3.5 years of treatment with 90 micrograms/week of Pegasys monotherapy was studied, no significant reductions were observed in the rate of fibrosis progression or related clinical events.
Maltese: Fi studju randomised, ikkontrollat fl-Istati Uniti (HALT-C) ta' pazjenti b'HCV bi gradi differenti ta' fibrożi li ma rrispondewx, fejn kienu studjati 3.5 snin ta' kura b'90 mikrogramma/ġimgħa ta' monoterapija ta' Pegasys, ma kien osservat l-ebda tnaqqis sinifikanti fir-rata ta' progressjoni tal fibrożi jew fl-avvenimenti kliniċi relatati.
English: Also contains sodium chloride, polysorbate 80, benzyl alcohol (see leaflet for futher information), sodium acetate, acetic acid and water for injections.
Maltese: Fih ukoll sodium chloride, polysorbate 80, benzyl alcohol (għal aktar informazzjoni ara l-fuljett ta' tagħrif), sodium acetate, acetic acid u ilma għall-injezzjonijiet.
English: Treatment with Pegasys was associated with decreases in haematological values (leucopenia, neutropenia, lymphopenia, thrombocytopenia and haemoglobin), which generally improved with dose modification, and returned to pre-treatment levels within 4-8 weeks upon cessation of therapy (see sections 4.2 and 4.4).
Maltese: Kura b'Pegasys kienet assoċjata ma' tnaqqis fil-valuri ematoloġiċi (lewkopenija, newtropenija, limfopenija, tromboċitopenija u emoglobina), li ġeneralment marru għall-aħjar b'bidla fid-doża, u reġgħu lura għal-livelli ta' qabel bdiet il-kura fi żmien 4-8 ġimgħat wara li waqfet it-terapija (ara sezzjonijiet 4.2 u 4.4).