FrancophonIA/ELRC3.0 huggingface dataset:
English: Immune system disorders: Idiopathic (or thrombotic) thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) Eye disorders: Loss of vision
Maltese: Disturbi fis-sistema immuni: Purpura (żieda fit-tbenġil, fsada, tnaqqis fil-plejtlits, anemija u debbulizza estrema) tromboċitopenika idjopatika (jew trombotika)
English: 55% (21 of 38) of subjects who completed the original study enrolled in the long-term follow up extending up to 6 years post-treatment.
Maltese: 55% (21 minn 38) tal-individwi li temmew l-istudju oriġinali rreġistraw fil-programm ta' segwitu fittul li jestendi sa 6 snin wara t-trattament.
English: From the NR16141study, 14 children 2 to 8 years of age with CHC received Pegasys monotherapy at a dose of: 180 mcg x BSA of the child/1.73 m2.
Maltese: Mill-istudju NR16141, 14-il tifel u tifla b'età minn sentejn sa 8 snin b'CHC irċevew monoterapija ta' Pegasys f'doża ta': 180 mcg x BSA tat-tifel/tifla/1.73 m2.
English: For children and adolescents 23 kg or greater, a dosing schedule using 200 mg ribavirin tablets is provided in Table 7.
Maltese: Għal tfal u adolexxenti ta' 23 kg jew aktar, skeda ta' dożaġġ bl-użu ta' pilloli ribavirin 200 mg hija pprovduta f'Tabella 7.
English: Neutropenia
Maltese: konvulżjonijiet
English: In a direct comparison with 90 micrograms, the 180 micrograms-dose was associated with superior sustained virological response in patients with cirrhosis, but in a study in non-cirrhotic patients very similar results were obtained with doses of 135 micrograms and 180 micrograms.
Maltese: Meta imqabbel direttament ma' 90 mikrogramma, id-doża ta' 180 mikrogramma kienet assoċjata ma' rispons viroloġiku sostenut akbar f'pazjenti b'ċirrożi, iżda fi studju b'pazjenti mhux ċirrotiċi b'dożi ta' 135 mikrogramma u 180 mikrogramma r-riżultati miksuba kienu simili ħafna.
English: There is limited experience with Pegasys in treating paediatric patients with CHC aged 3 to 5 years, or who have failed to be adequately treated previously.
Maltese: Hemm esperjenza limitata b'Pegasys fil-kura ta' pazjenti pedjatriċi b'CHC b'età minn 3 sa 5 snin, jew li naqsu milli jiġu kkurati qabel b'mod adegwat.
English: Table 13: Virological response in CHC patients Pegasys monotherapy
Maltese: Tabella 13: Rispons viroloġiku f'pazjenti b'CHC
English: A subsequent study (NV18209) in patients co-infected with HCV genotype 1 and HIV compared treatment using Pegasys 180 mcg/week and either ribavirin 800 mg or 1000 mg (<75 kg)/1200 mg (≥75 kg) daily for 48 weeks.
Maltese: Studju sussegwenti (NV18209) f'pazjenti ko-infettati bil-ġenotip 1 ta' HCV u HIV qabbel il-kura blużu ta' Pegasys 180 mcg/ġimgħa flimkien ma' ribavirin 800 mg jew 1000 mg (<75 kg)/1200 mg (≥75 kg) kuljum għal 48 ġimgħa.
English: 3 x 200 mg tablets A.M. 3 x 200 mg tablets P.M.
Maltese: 3 pilloli x 200 mg A.M. 3 pilloli x 200 mg P.M.
English: The risk of growth inhibition should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response (for HBVinfection mainly HBV genotype and ALT levels; for HCV-infection mainly HCV genotype and HCV-RNA levels) (see section 5.1).
Maltese: bħal evidenza ta' progressjoni tal-marda (l-aktar fibrożi), ko-morbożitajiet li jistgħu jinfluwenzaw b'mod negattiv il-progressjoni tal-marda (bħal ko-infezzjoni b'HIV), kif ukoll fatturi pronjostiċi ta' rispons (għal infezzjoni bl-HBV prinċipalment ġenotip tal-HBV u livelli tal-ALT; għal infezzjoni blHCV prinċipalment ġenotip tal-HCV u livelli tal-RNA ta' HCV) (ara sezzjoni 5.1).
English: Where dose adjustment is required for moderate to severe adverse reactions (clinical and/or laboratory) initial dose reduction to 135 micrograms is generally adequate for adult patients.
Maltese: Fejn ikun hemm bżonn ta' tibdil fid-doża minħabba reazzjonijiet avversi moderati sa severi (kliniċi u/jew fil-laboratorju) tnaqqis inizjali fid-doża għal 135 mikrogramma ġeneralment huwa adegwat għall-pazjenti adulti.
English: Genotype 2 or 3
Maltese: Ġenotip 2 jew 3
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Maltese: L-użu ta' ribavirin flimkien ma' zidovudine mhux rakkomandat minħabba żieda fir-riskju ta' anemija (ara sezzjoni 4.4).
English: Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 16).
Maltese: Għalkemm limitata, id-dejta tindika li tqassir tal-kura għal 24 ġimgħa jista' jkun assoċjat ma' riskju akbar li wieħed jirkadi (ara Tabella 16).
English: Roche Pharma AG Emil-Barell-Str. 1
Maltese: Emil-Barell-Strasse 1
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.5).
Maltese: L-użu ta' ribavirin flimkien ma' zidovudine mhux rakkomandat minħabba żieda fir-riskju ta' anemija (ara sezzjoni 4.5).
English: Ribavirin 1000/1200 mg 48 Weeks (N = 469) SVR in Pts with VR at Wk 12 b
Maltese: 48 Ġimgħa (N = 469) SVR f'Pażjenti b' VR f'Ġimgħa 12 b (N = 57)
English: Consideration should be given to continuing treatment with more frequent monitoring of liver function during ALT flares.
Maltese: Għandha tingħata konsiderazzjoni għat-tkomplija tal-kura b'sorveljanza aktar frekwenti tal-funzjoni tal-fwied waqt żidiet għoljin ħafna ta' ALT.
English: Low viral load High viral load
Maltese: Viral load baxxa
English: Exposure to Pegasys was decreased in studies following administration of Pegasys in the arm (see section 5.2).
Maltese: Esponiment għal Pegasys kien imnaqqas fi studji wara l-għoti ta' Pegasys fid-dirgħajn (ara sezzjoni 5.2).
English: Pegasys 135 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a*.
Maltese: Pegasys 135 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa ta' 0.5 ml ta' soluzzjoni fiha 135 mikrogramma peginterferon alfa-2a*.
English: Table 23: HBeAg seroconversion rates (%) by HBV genotype and baseline ALT levels Group A (Pegasys treatment) (N=101)
Maltese: Tabella 23: Rati (%) ta' serokonverżjoni ta' HBeAg skont il-ġenotip tal-HBV u l-livelli tal-ALT fil-linja bażi
English: The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials on a case by case basis (see sections 4.8 and 5.1).
Maltese: Il-benefiċċju mistenni tal-kura għandu jiġi meqjus b'attenzjoni kontra s-sejbiet ta' sigurtà osservati għat-tfal u l-adolexxenti fil-provi kliniċi fuq bażi ta' każ każ (ara sezzjonijiet 4.8 u 5.1).
English: A clinical trial investigating the combination of telbivudine 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration for the treatment of HBV, indicates that the combination is associated with an increased risk for developing peripheral neuropathy.
Maltese: Prova klinika li nvestigat it-taħilita ta' telbivudine 600 mg kuljum, ma' interferon alfa-2a pegilat, 180 mikrogramma darba fil-ġimgħa permezz ta' għoti minn taħt il-ġilda għall-kura ta' HBV, tindika li t-taħlita hija assoċjata ma' żieda fir-riskju ta' żvilupp ta' newropatija periferali.
English: Adult chronic hepatitis C prior treatment non-responder patients In study MV17150, patients who were non-responders to previous therapy with pegylated interferon alfa-2b plus ribavirin were randomised to four different treatments:
Maltese: Pazjenti adulti b'epatite Ċ kronika li ma rrispondewx għall-kura ta' qabel Fl-istudju MV17150, pazjenti li ma kinux irrispondew għal terapija ta' qabel b'interferon alfa-2b pegilat flimkien ma' ribavirin kienu randomised għal erba' kuri differenti:
English: Based on the population pharmacokinetic model, the mean exposure (AUC) during the dosing interval for each BSA category was comparable with that observed in adults receiving 180 mcg fixed dosing.
Maltese: Abbażi tal-mudell farmakokinetiku tal-popolazzjoni, l-esponiment medju (AUC) matul l-intervall tad dożaġġ għal kull kategorija ta' BSA kien komparabbli ma' dak osservat f'pazjenti adulti li jirċievu dożaġġ ta' 180 mcg.
English: Table 15: Sustained virological response based on rapid viral response at week 4 for genotype 1 and 4 after Pegasys combination therapy with ribavirin in CHC patients
Maltese: Rispons viroloġiku sostenut ibbażat fuq rispons virali rapidu f'ġimgħa 4 f'pazjenti b'CHC ta' ġenotip 1 u 4 wara terapija kombinata ta' Pegasys ma' ribavirin
English: Pegasys is indicated for the treatment of HBeAg-positive CHB in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum ALT levels.
Maltese: Pegasys huwa indikat għat-trattament ta' CHB pożittiva għal HBeAg fi tfal u adolexxenti mhux b'ċirrożi b'età minn 3 snin 'il fuq b'evidenza ta' replikazzjoni virali u żidiet persistenti fil-livelli talALT fis-serum.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency 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: Studies in animals with interferon alfa-2a have shown reproductive toxicity (see section 5.3) and the potential risk for humans is unknown.
Maltese: Studji f'annimali b'interferon alfa-2a urew effett tossiku fuq is-sistema riproduttiva (ara 5.3) u mhux magħruf r-riskju potenzjali fuq in-nies.
English: Available in packs of 1 or 4 vials.
Maltese: Disponibbli f'pakketti ta' kunjett 1 jew 4 kunjetti.
English: Specific recommendations for management of treatment-emergent anaemia in adults are as follows: ribavirin should be reduced to 600 milligrams/day (200 milligrams in the morning and 400 milligrams in the evening) if either of the following apply: (1) a patient without significant cardiovascular disease experiences a fall in haemoglobin to < 10 g/dl and ≥ 8.5 g/dl, or (2) a patient with stable cardiovascular disease experiences a fall in haemoglobin by ≥ 2 g/dl during any 4 weeks of treatment.
Maltese: Rakkomandazzjonijiet speċifiċi għall-immaniġġar ta' anemija fl-adulti li tiżviluppa waqt il-kura huma kif ġej: ribavirin għandu jitnaqqas għal 600 milligramma/jum (200 milligramma filgħodu u 400 milligramma filgħaxija) jekk tapplika xi waħda minn dawn li jmiss: (1) pazjent mingħajr mard kardjovaskulari sinifikanti li jkollu tnaqqis fil-livell tal-emoglobina għal < 10 g/dl u ≥ 8.5 g/dl, jew (2) pazjent b'mard kardjovaskulari stabbli li jkollu tnaqqis fil-livell tal-emoglobina b'≥ 2 g/dl waqt kwalunkwe 4 ġimgħat ta' kura.
English: Abdominal pain upper, stomatitis, nausea, aphthous stomatitis, oral disorder
Maltese: Uġigħ fil-parti ta' fuq tal-addome, stomatite, tqalligħ, stomatite bl-afta, disturb orali
English: Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with CHC treated with interferon.
Maltese: • jekk għandek ukoll HIV u qiegħed tiġi kkurat bi prodotti mediċinali kontra l-HIV.
English: Ribavirin 1000/1200 mg 72 or 48 Weeks (N = 942) Pts with VR at Wk 12 a
Maltese: 72 jew 48 Ġimgħa (N = 942) Pażjenti b' VR f'Ġimgħa 12 a (N = 876)
English: Wheezing Interstitial pneumonitis including fatal outcome, pulmonary embolism
Maltese: Pnewmonite interstizjali inkluż riżultat fatali,
English: Pegasys dosing
Maltese: Tużax Pegasys
English: Superior efficacy of Pegasys compared to interferon alfa-2a was demonstrated also in terms of histological response, including patients with cirrhosis and/or HIV-HCV co-infection.
Maltese: L-effikaċja superjuri ta' Pegasys meta mqabbla ma' dik ta' interferon alfa-2a dehret anki bħala rispons istoloġiku, inkluż pazjenti b'ċirrożi u/jew ko-infezzjoni b'HIV-HCV.
English: One step dose modification (Approx. 7.5 mg/kg/day)
Maltese: (Madwar 7.5 mg/kg/jum)
English: 4 vials
Maltese: < 500 ċellula
English: Dose reduction to 90 micrograms is recommended if the platelet count is 25,000 to < 50,000 cells/mm3.
Maltese: Huwa rakkomandat li d-doża titnaqqas għal 90 mikrogramma jekk in-numru ta' plejtlits huwa 25,000 sa < 50,000 ċellula /mm3.
English: Psychiatric and nervous system disorders: Thoughts of suicide, hallucinations (severe problems with personality and deterioration in normal social functioning), peripheral neuropathy (disorder of the nerves affecting the extremities)
Maltese: Suwiċidju, disturbi psikotiċi (problemi severi tal-personalità u deterjorament fil-funzjoni soċjali normali), koma (tintilef minn sensik fil-fond u fit-tul),
English: Each vial of 1.0 ml solution contains 180 micrograms peginterferon alfa-2a.
Maltese: Kull kunjett ta' 1.0 ml ta' soluzzjoni fih 180 mikrogramma peginterferon alfa-2a.
English: Pancytopenia and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the administration of a peginterferon and ribavirin concomitantly with azathioprine.
Maltese: Fil-letteratura, panċitopenija u soppressjoni tal-mudullun tal-għadam kienu rrappurtati li jseħħu fi żmien 3 sa 7 ġimgħat wara l-għoti ta' peginterferon u ribavirin flimkien ma' azathioprine.
English: In both studies, Pegasys apparent clearance and apparent volume of distribution were related linearly to body size ie. either BSA (NR16141) or body weight (YV25718).
Maltese: Fiż-żewġ studji, it-tneħħija apparenti u l-volum ta' distribuzzjoni apparenti ta' Pegasys kienu relatati b'mod lineari mad-daqs tal-ġisem, jiġifieri l-BSA (NR16141) jew il-piż tal-ġisem (YV25718).
English: Multipack: 12 (2 packs of 6) pre-filled syringes + 12 injection needles 135 micrograms/0.5 ml
Maltese: Pakkett b'ħafna: 12-il siringa mimlija għal-lest (2 pakketti ta' 6) + 12-il labra għall-injezzjoni
English: * Subgroup of patients with genotype D had a higher proportion with baseline ALT < 1.5x ULN (13/31) compared to other genotype groups ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
Maltese: * Sottogrupp ta' pazjenti bil-ġenotip D kellhom proporzjon ogħla b'ALT fil-linja bażi < 1.5x ULN (13/31) meta mqabbel ma' gruppi ta' ġenotip ieħor (16/70). ** Pazjenti li qalbu għal trattament b'Pegasys wara l-perjodu prinċipali ta' osservazzjoni u qabel Ġimgħa 24 ta' segwitu kienu magħduda bħala li ma rrispondewx.
English: The recommended total duration of therapy is 48 weeks.
Maltese: It-tul totali rakkomandat ta' terapija huwa ta' 48 ġimgħa.
English: In HIV-HCV co-infected patients, the clinical adverse reaction profiles reported for Pegasys, alone or in combination with ribavirin, were similar to those observed in HCV mono-infected patients.
Maltese: F'pazjenti ko-infettati b'HIV-HCV, il-profili ta' reazzjonijiet avversi kliniċi rrappurtati għal Pegasys, waħdu jew f'taħlita ma' ribavirin, kienu simili għal dawk osservati f'pazjenti infettati biss b'HCV.
English: HBeAg negative / anti-HBe positive Study WV16241
Maltese: Negattivi għal HBeAg / pożittivi għal anti-HBe
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 135 µg PRE-FILLED PENS
Maltese: KARTUNA TA' BARRA - 4 PINNEN MIMLIJA GĦAL-LEST x 135 µg
English: Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be re-assessed (see also Endocrine system in sections 4.4 and 4.8).
Maltese: Pazjenti b'sinjali jew b'sintomi kompatibbli ma' mard awtoimmuni għandhom jiġu evalwati bir-reqqa, u rriskju-benefiċju li titkompla t-terapija b'interferon għandu jerġa' jiġi evalwat (ara wkoll Sistema endokrinarja f'sezzjonijiet 4.4 u 4.8).
English: Withhold ribavirin
Maltese: Użu ma' ribavirin
English: Table 19: Week 12 virological response (VR) and sustained virological response (SVR) in patients with virological response at week 12 after treatment with Pegasys and ribavirin combination therapy in nonresponders to peginterferon alfa-2b plus ribavirin Study MV17150 Pegasys 360/180 or 180 mcg
Maltese: Rispons viroloġiku (VR) f'ġimgħa 12 u rispons viroloġiku sostenut (SVR) f'pazjenti b'rispons viroloġiku f'ġimgħa 12 wara kura b'terapija kombinata ta' Pegasys u ribavirin f'dawk li ma rrispondewx għal peginterferon alfa-2b flimkien ma' ribavirin.
English: This would be particularly important in patients with a known history of zidovudine induced anaemia.
Maltese: Dan ikun importanti b'mod partikolari f'pazjenti b'passat magħruf ta' anemija ikkaġunata minn zidovudine.
English: For HBeAg-positive patients with HBV genotype B and C infection, HBsAg > 20,000 IU/mL or HBV DNA > 8 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBeAg seroconversion and HBV-DNA <2,000 IU/mL at 24 week post-treatment (NPV > 90%).
Maltese: IU/mL f'Ġimgħa 12 wara bidu tat-trattament huwa assoċjat ma' probabbiltà għolja ta' falliment biex tintlaħaq serokonverżjoni ta' HBeAg u DNA ta' HBV ta' <2,000 IU/mL f'Ġimgħa 24 wara t-trattament (NPV ta' > 90%).
English: Ribavirin daily dose (Approx. 15 mg/kg/day)
Maltese: Doża ta' kuljum ta' ribavirin (Madwar 15-il mg/kg/jum)
English: For children and adolescents aged 3 to 17 years with CHB and having a BSA greater than 0.54 m2 and for children and adolescents aged 5 to 17 years with CHC and having a BSA greater than 0.71 m2, the recommended doses for Pegasys are provided in Table 4.
Maltese: Għal tfal u adolexxenti b'età minn 3 snin sa 17-il sena b'CHB u li għandhom BSA ogħla minn 0.54 m2 u għal tfal u adolexxenti b'età minn 5 snin sa 17-il sena b'CHC u li għandhom BSA akbar minn 0.71 m2, id-dożi rakkomandati għal Pegasys huma pprovduti f'Tabella 4.
English: Pegasys 90 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 90 mcg, 65 mcg, 45 mcg, 30 mcg, 20 mcg and 10 mcg.
Maltese: Is-siringa hija ttikkettjata bi gradwazzjonijiet li jikkorrispondu għal dożi ta' 90 mcg, 65 mcg, 45 mcg,
English: The metabolism of Pegasys is not fully characterised; however studies in rats indicate that the kidney is a major organ for excretion of radiolabelled material.
Maltese: Il-metaboliżmu ta' Pegasys m'huwiex karatterizzat kompletament; iżda studji li saru fil-far jindikaw li l-kilwa hija l-organu prinċipali involuta fit-tneħħija ta' materjal radjutikkettat.
English: Confirmatory clinical trials in adult treatment-naïve patients All clinical trials recruited interferon-naïve patients with CHC confirmed by detectable levels of serum HCV RNA, elevated levels of ALT (with the exception of study NR16071) and a liver biopsy consistent with chronic hepatitis.
Maltese: Provi kliniċi konfermatorji f'pazjenti adulti li qatt ma ħadu kura qabel Fil-provi kliniċi kollha, iddaħħlu pazjenti li qatt ma ħadu interferon qabel u li kienu konfermati li jsofru minn CHC mil-livelli mkejla fis-serum ta' RNA ta' HCV, livelli elevati ta' ALT (bl-eċċezzjoni ta' studju NR16071) u minn bijopsija tal-fwied konsistenti ma' epatite kronika.
English: Haemoglobin - no cardiac disease
Maltese: Emoglobina - marda kardijaka stabbli
English: For patients <75 kg and ≥75 kg, 1000 mg daily and 1200 mg daily of ribavirin, respectively, and regardless of genotype, should be administered.
Maltese: <75 kg u ≥75 kg, għandhom jingħataw 1000 mg kuljum u 1200 mg kuljum ta' ribavirin, rispettivament.
English: Table 17: Sustained virological response overall and based on rapid viral response by week 4 for genotype 2 or 3 after Pegasys combination therapy with ribavirin in CHC patients
Maltese: Tabella 17: Rispons viroloġiku sostenut totali u bbażat fuq rispons virali rapidu mar-raba' ġimgħa għall-ġenotip 2 jew 3 wara terapija kombinata ta' Pegasys b'ribavirin f'pazjenti b'CHC
English: For spontaneous reports of undesirable effects from post-marketing experience, the frequency is not known (cannot be estimated from the available data).
Maltese: Għal rapporti spontanji ta' effetti mhux mixtieqa minn esperjenza ta' wara t-tqegħid fis-suq, il-frekwenza mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: How to use Pegasys
Maltese: Doża ta' Pegasys
English: Tel: +385 1 47 22 333
Maltese: Roche d.o.o Tel: +385 1 47 22 333
English: In study NV17317 in patients infected with viral genotype 2 or 3, all patients received Pegasys 180 mcg sc qw and a ribavirin dose of 800 mg and were randomised to treatment for either 16 or 24 weeks.
Maltese: Fi studju NV17317 f'pazjenti infetti b'ġenotip virali 2 jew 3, il-pazjenti kollha rċevew Pegasys 180 mcg sc qw u doża ta' ribavirin ta' 800 mg u kienu randomised għall-kura ta' 16 jew 24 ġimgħa.
English: Vertigo, earache
Maltese: Vertigo, uġigħ fil-widna
English: In patients with compensated cirrhosis (e.g., Child-Pugh A), Pegasys has been shown to be effective and safe.
Maltese: F'pazjenti b'ċirrożi kumpensata (eż., Child-Pugh A), Pegasys deher li huwa effettiv u mingħajr periklu.
English: Gastrointestin al bleeding
Maltese: Test Eżatt ta' Fisher
English: A patient-level meta-analysis of 9 Pegasys clinical studies (n=1,423) in CHB HBeAg positive and HBeAg-negative patients demonstrated that HBsAg and HBV DNA levels at Week 12 of treatment, are predictive of final treatment outcome at Week 24 post-treatment in certain genotypes.
Maltese: Metaanaliżi fil-livell tal-pazjenti ta' 9 studji kliniċi dwar Pegasys (n=1,423) f'pazjenti b'CHB pożittivi għal HBeAg u negattivi għal HBeAg uriet li l-livelli ta' HBsAg u tad-DNA ta' HBV f'Ġimgħa 12 tattrattament, ibassru r-riżultat finali tat-trattament f'Ġimgħa 24 wara t-trattament f'ċerti ġenotipi.
English: Ascites
Maltese: Sepsi
English: ● Remove the syringe from the wrapping.
Maltese: lipodistrofija miksuba u kromaturja.
English: ● Remove the rubber cap from the syringe (3).
Maltese: ● Neħħi l-għatu tal-lastku minn mas-siringa (3).
English: Pneumonia, skin infection
Maltese: Infezzjoni fil-pulmun, infezzjonijiet fil-ġilda
English: The virological responses of HCV monoinfected patients treated with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 14 and Table 15, respectively.
Maltese: Ir-rispons viroloġiku ta' pazjenti infettati biss b'HCV ikkurati b'terapija kkombinata ta' Pegasys u ribavirin f'relazzjoni mal-ġenotip u l-viral load ta' qabel il-kura u f'relazzjoni mal-ġenotip, il-viral load ta' qabel il-kura u rispons viroloġiku rapidu f'ġimgħa 4 huma miġbura fil-qosor f'Tabella 14 u f'Tabella 15, rispettivament.
English: Vision loss Serous retinal detachment
Maltese: Distakk seruż tar-retina
English: The average molecular mass is approximately 60,000 of which the protein moiety constitutes approximately 20,000.
Maltese: 60,000 li minnu l-parti tal-proteina tikkostitwixxi madwar 20,000.
English: HBV genotype A subgroup size was insufficient to be analyzed.
Maltese: id-daqs tas-sottogrupp ma kienx biżżejjed biex jiġi analizzat.
English: Consideration for early treatment discontinuation should be evaluated in the context of a particular clinical situation.
Maltese: Konsiderazzjoni għat-twaqqif bikri tat-trattament għandha tkun evalwata fil-kuntest ta' sitwazzjoni klinika partikolari.
English: Severe adverse reactions were reported in 2 patients in the Pegasys plus ribavirin combination therapy group (hyperglycaemia and cholecystectomy).
Maltese: Reazzjonijiet avversi severi kienu rrappurtati f'żewġ pazjenti fil-grupp ta' terapija kombinata ta' Pegasys flimkien ma' ribavirin (ipergliċemija u tneħħija tal-marrara).
English: Seven patients receiving combination Pegasys and ribavirin treatment for 48 weeks discontinued therapy for safety reasons (depression, psychiatric evaluation abnormal, transient blindness, retinal exudates, hyperglycaemia, type 1 diabetes mellitus, and anaemia).
Maltese: (depressjoni, valutazzjoni psikjatrika mhux normali, telf temporanju tal-vista, tnixxija mir-retina, ipergliċemija, dijabete mellitus tip 1, u anemija).