FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended duration of therapy is 48 weeks in patients with CHB. Before initiating therapy for CHB, persistently elevated serum ALT levels should have been documented.
Maltese: Qabel ma tinbeda terapija għal CHB, livelli ta' ALT fis-serum għoljin b'mod persistenti kellhom jiġu dokumentati.
English: Vomiting, dyspepsia, dysphagia, mouth ulceration, gingival bleeding, glossitis, stomatitis, flatulence, dry mouth
Maltese: nażofarinġite, konġestjoni fis sinus, konġestjoni tal imnieħer, rinite, uġigħ fil-griżmejn
English: The frequency and severity of the most commonly reported adverse reactions with Pegasys are similar to those reported with interferon alfa-2a (see Table 9).
Maltese: Il-frekwenza u s-severità tar-reazzjonijiet avversi rrappurtati l-aktar ta' spiss b'Pegasys huma simili għal dawk irrappurtati b'interferon alfa-2a (ara Tabella 9).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a.
Maltese: Kull siringa ta' 0.5 ml ta' soluzzjoni fiha 135 mikrogramma ta' peginterferon alfa-2a.
English: Paediatric patients 5 years of age and older
Maltese: Pazjenti pedjatriċi b'età minn 5 snin 'l fuq
English: 500 to < 750 cells/mm3: Immediate 1 level adjustment.
Maltese: 500 sa <750 ċellula/mm3: Aġġustament immedjat ta' livell wieħed.
English: Metabolic disorders: Loss of appetite
Maltese: Disturbi metaboliċi:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg VIALS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA - 4 KUNJETTI x 180 µg
English: Pegasys treatment was associated with clinically significant abnormalities in thyroid laboratory values requiring clinical intervention (see section 4.4).
Maltese: Kura b'Pegasys kienet assoċjata ma' anormalitajiet ta' sinifikanza klinika fir-riżultati tal-laboratorju tat-tirojde li kellhom bżonn intervent kliniku (ara sezzjoni 4.4).
English: Roche a/s c/o Icepharma hf Simi: +354 540 8000
Maltese: Ísland Roche a/s c/o Icepharma hf
English: Dyspnoea exertional, epistaxis, nasopharyngit is, sinus congestion, nasal congestion, rhinitis, sore throat
Maltese: disfaġja, ulċeri fil-ħalq, ħanek inixxi d-demm, infjammazzjoni tal-ilsien, stomatite, gass,
English: Syncope, migraine, memory impairment, weakness, hypoaesthesia hyperaesthesi a, paraesthesia, tremor, taste disturbance, nightmares, somnolence
Maltese: Sinkope, emigranja, indeboliment fil-memorja, debbulizza, ipoestesija, iperestesija, parestesija,
English: Side effects with unknown frequency:
Maltese: Effetti sekondarji bi frekwenza mhux magħrufa:
English: Each pre-filled syringe of 0.5 ml solution contains 90, 135 or 180 micrograms peginterferon alfa-2a.
Maltese: Kull pinna mimlija għal-lest ta' 0.5 ml ta' soluzzjoni fiha 135 jew 180 mikrogramma peginterferon alfa-2a.
English: All HCV genotypes** HCV genotype 1
Maltese: Għall-pazjenti nfettati b'HCV ġenotip 1, b'piż
English: Patients predisposed to the development of autoimmune disorders may be at increased risk.
Maltese: jista' jkollok temporanjament riskju ogħla ta' infezzjoni.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a.
Maltese: Kull siringa ta' 0.5 ml ta' soluzzjoni fiha 90 mikrogramma peginterferon alfa-2a*.
English: The pharmacokinetics of Pegasys were similar between healthy subjects and patients with hepatitis B or C. Comparable exposure and pharmacokinetic profiles were seen in cirrhotic (Child-Pugh Grade A) and non-cirrhotic patients.
Maltese: Kien hemm espożizzjoni u profili farmakokinetiċi komparabbli f'pazjenti b'ċirrożi (Child-Pugh ta' Grad A) u f'pazjenti mingħajr ċirrożi.
English: Response rates in groups A and B at the end of 24 weeks follow-up are presented in Table 22.
Maltese: A u B fl-aħħar ta' 24 ġimgħa ta' segwitu huma ppreżentati f'Tabella 22.
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa products, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis).
Maltese: Każijiet ta' pressjoni għolja fl-arterja tal-pulmun (PAH - pulmonary arterial hypertension) kienu rrappurtati bi prodotti li fihom interferon alfa, b'mod partikolari f'pazjenti b'fatturi ta' riskju għal PAH (bħal pressjoni portali għolja, infezzjoni bl-HIV, ċirrożi).
English: In patients co-infected with HIV-HCV, limited efficacy and safety data are available in patients with CD4 counts less than 200 cells/µl.
Maltese: F'pazjenti ko-infettati b'HIV-HCV, dejta limitata dwar l-effikaċja u s-sigurtà hija disponibbli f'pazjenti b'għadd ta' CD4 inqas minn 200 ċelluli/µl.
English: Prior to beginning Pegasys therapy, standard haematological and biochemical laboratory tests are recommended for all patients.
Maltese: Qabel ma tinbeda terapija b'Pegasys, huwa rakkomandat li jsiru testijiet ematoloġiċi u bijokimiċi standard tal-laboratorju fil-pazjenti kollha.
English: Adverse events were experienced by 88% of Pegasys-treated patients as compared with 53% of patients in the lamivudine comparator group, while 6% of the Pegasys-treated and 4% of the lamivudine-treated patients experienced serious adverse events during the studies.
Maltese: Każijiet avversi seħħew fi 88% tal-pazjenti ttrattati b'Pegasys meta mqabbel ma' 53% tal-pazjenti filgrupp ta' paragun b'lamivudine, filwaqt li 6% tal-pazjenti ttrattati b'Pegasys u 4% tal-pazjenti ttrattati b'lamivudine kellhom każijiet avversi serji waqt l-istudji.
English: Genotype 2/3
Maltese: Ġenotip 1/4
English: It is unknown whether peginterferon alfa-2a/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk peginterferon alfa-2a/metaboliti jiġux eliminati fil-ħalib tas-sider tal-bniedem.
English: In CHB or CHC patients, peginterferon alfa-2a serum concentrations accumulate 2 to 3 fold after 6 to 8 weeks of once weekly dosing compared to single dose values.
Maltese: F'pazjenti b'CHB jew CHC, il-konċentrazzjonijiet ta' peginterferon alfa-2a fis-serum jakkumulaw b'2 sa 3 darbiet aktar wara li ngħataw doża darba fil-ġimgħa għal 6 sa 8 ġimgħat meta mqabbla ma' figuri ta' doża waħda.
English: Weekly dose (mcg)
Maltese: Doża tal-bidu (mcg)
English: Infections: Infection of the heart, infection of the external ear Blood disorders: Severe reduction in red blood cells, white blood cells and platelets Immune system disorders: Severe allergic reaction, systemic lupus erythematosus (an illness where the body attacks its own cells), rheumatoid arthritis (an autoimmune disease) Hormone system disorders: Diabetic ketoacidosis, a complication of uncontrolled diabetes Psychiatric and nervous system disorders: Suicide, psychotic disorders (severe problems with personality and deterioration in normal social functioning), coma (a deep prolonged unconsciousness), seizures, facial palsy (weakness of the facial muscle) Eye disorders: Inflammation and swelling of the optic nerve, inflammation of the retina, ulceration of the cornea
Maltese: Suwiċidju, disturbi psikotiċi (problemi severi tal-personalità u deterjorament fil-funzjoni soċjali normali), koma (tintilef minn sensik fil-fond u fit-tul), aċċessjonijiet, paralisi fil-wiċċ (indebboliment fil-muskoli tal-wiċċ) Disturbi fl-għajnejn:
English: 12 pre-filled pens
Maltese: Tagħmlux fil-friża
English: Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Maltese: Disturbi dentali u tal-ħanek, li jistgħu jwasslu għal telf ta' snien, kienu rrappurtati f'pazjenti li kienu qed jirċievu terapija kombinata ta' Pegasys u ribavirin.
English: In individual cases where the benefit of administering ribavirin concomitantly with azathioprine warrants the potential risk, it is recommended that close haematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicinal products should be stopped (see section 4.4).
Maltese: F'każijiet individwali fejn il-benefiċċju tal-għoti ta' ribavirin flimkien ma' azathioprine jiġġustifika r-riskju potenzjali, huwa rakkomandat li ssir sorveljanza ematoloġika mill-viċin waqt l-użu flimkien ma' azathioprine biex jiġu identifikati sinjali ta' majelotossiċità, u f'dan il-waqt il-kura b'dawn il-prodotti mediċinali għandha titwaqqaf (ara sezzjoni 4.4).
English: At the end of treatment, 43% of patients experienced a weight percentile decrease of 15 percentiles or more, and 25% (13 of 53) experienced a height percentile decrease of 15 percentiles or more on the normative growth curves.
Maltese: Fit-tmiem tat-trattament, 43% tal-pazjenti kellhom tnaqqis fil-perċentili tal-piż ta' 15-il perċentili jew aktar, u 25% (13 minn 53) kellhom tnaqqis fil-perċentili tat-tul ta' 15-il perċentili jew aktar fuq il-kurvi tat-tkabbir normattiv.
English: Pegasys 90 micrograms solution for injection in pre-filled syringe Pegasys 135 micrograms solution for injection in pre-filled syringe Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Maltese: Pegasys 90 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Pegasys 135 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Pegasys 180 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a.
Maltese: Kull siringa ta' 0.5 ml ta' soluzzjoni fiha 180 mikrogramma peginterferon alfa-2a*.
English: The mean changes from baseline in height and weight for age Z-scores at Week 48 of treatment in study YV25718 were -0.07 and -0.21 (n=108 and n= 106 respectively) for Pegasys-treated patients as compared to -0.01 and -0.08 (n=47 each) in untreated patients.
Maltese: Il-bidliet medji mil-linja bażi fit-tul u l-piż għall-punteġġi Z tal-età f'Ġimgħa 48 tat-trattament fl istudju YV25718 kienu -0.07 u -0.21 (n=108 u n= 106 rispettivament) għall-pazjenti ttrattati b'Pegasys meta mqabbla ma' -0.01 u -0.08 (n=47 kull wieħed) f'pazjenti mhux ittrattati.
English: Pegasys 180 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 180 mcg, 135 mcg and 90 mcg.
Maltese: Is-siringa hija ttikkettjata bi gradwazzjonijiet li jikkorrispondu għal dożi ta' 180 mcg, 135 mcg u 90 mcg.
English: Virological response was defined as undetectable HCV RNA as measured by the COBAS AMPLICOR HCV Test, version 2.0 (limit of detection 100 copies/ml equivalent to 50 International Units/ml) and sustained response as one negative sample approximately 6 months after end of therapy.
Maltese: AMPLICOR HCV, verżjoni 2.0 (limitu tal-kejl ta' 100 kopja/ml ekwivalenti għal 50
English: In the HALT-C study, patients with CHC and advanced fibrosis or cirrhosis who were non-responders to previous treatment with interferon alfa or pegylated interferon alfa monotherapy or in combination therapy with ribavirin were treated with Pegasys 180 mcg/week and ribavirin 1000/1200 mg daily.
Maltese: Fl-istudju HALT-C, pazjenti b'CHC u b'fibrożi avanzata jew ċirrożi li ma rrispondewx għall-kura ta' qabel b'interferon alfa jew interferon alfa pegilat bħala monoterapija jew f'terapija kombinata ma' ribavirin kienu kkurati b'Pegasys 180 mcg/ġimgħa u ribavirin 1000/1200 mg kuljum.
English: (N=88) 48 weeks
Maltese: (N=88)
English: Ribavirin therapy is contraindicated in women who are pregnant.
Maltese: Terapija b'ribavirin hija kontraindikata f'nisa waqt it-tqala.
English: In 13 patients with ESRD requiring chronic HD, administration of Pegasys 135 mcg once weekly resulted in 34% lower peginterferon alfa-2a exposure than in patients with normal renal function.
Maltese: Fi 13-il pazjent b'ESRD li kienu jeħtieġu HD kronika, l-għoti ta' Pegasys 135 mcg darba fil-ġimgħa wasslet għal esponiment għal peginterferon alfa-2a inqas b'34% minn f'pazjenti b'funzjoni tal-kliewi normali.
English: In case of intolerance to ribavirin, Pegasys monotherapy should be continued.
Maltese: F'każ ta' intolleranza għal ribavirin, għandha titkompla monoterapija b'Pegasys.
English: Table 2: Predictive value of week 12 virological response at the recommended dosing regimen while on Pegasys combination therapy in adult patients with chronic hepatitis C Genotype
Maltese: Tabella 2: Valur imbassar tar-rispons viroloġiku ta' ġimgħa 12 bil-kors ta' dożaġġ rakkomandat waqt terapija kombinata ta' Pegasys f'pazjenti adulti b'epatite Ċ kronika
English: Platelet Count
Maltese: Tibdil okulari
English: Chest pain, influenza like illness, malaise, lethargy, hot flushes, thirst
Maltese: Uġigħ fis-sider, marda tixbaħ lill-influwenza, telqa (ma tħossokx tajjeb), letarġija, fwawar, għatx
English: HBeAg-negative(a)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Pegasys 180 mcg Ribavirin mg (N=436) 48 weeks
Maltese: Ribavirin mg (N=436)
English: Viewing window
Maltese: Telf tal-vista
English: Dose limiting toxicities were fatigue, elevated liver enzymes, neutropenia and thrombocytopenia, consistent with interferon therapy.
Maltese: Tossiċitajiet li llimitaw id-doża kienu għeja, livelli għoljin ta' enżimi tal-fwied, newtropenija u tromboċitopenija, konsistenti ma'
English: The Pegasys pre-filled pen is intended to be used in a home-setting by patients who have been properly instructed.
Maltese: Pegasys titnaqqas jew titwaqqaf, it-terapija tista' terġa' titkompla la darba iż-żieda qawwija tibda tbatti
English: Interferon alfa-2a is conjugated with bis-[monomethoxy polyethylene glycol] at a degree of substitution of one mole of polymer/mole of protein.
Maltese: Interferon alfa-2a huwa kkonjugat ma' bis-[monomethoxy polyethylene glycol] fi grad ta'
English: 2 x 200 mg tablets A.M. 2 x 200 mg tablets P.M.
Maltese: 800 mg/jum2 pilloli x 200 mg A.M. 2 pilloli x 200 mg P.M.
English: Overall Low viral load High viral load Genotype 1/4 Low viral load High viral load Genotype 2/3 Low viral load High viral load Cirrhosis Status Cirrhosis Noncirrhosis Best Response during Previous Treatment ≥2log10 decline in HCV RNA <2log10 decline in HCV RNA Missing best previous response
Maltese: IU/ml) fil-linja bażi li jsiru negattivi għall-RNA ta' HCV f'ġimgħa 4 u jibqgħu negattivi għall-RNA ta' HCV f'ġimgħa 24 għandu jiġi kkunsidrat b'aktar kawtela minħabba dejta limitata disponibbli li tissuġġerixxi li dan jista' jkollu effett negattiv b'mod sinifikanti fuq ir-rispons viroloġiku sostenut.
English: Pegasys contains the active substance peginterferon alfa-2a, which is a long-acting interferon.
Maltese: Pegasys fih is-sustanza attiva peginterferon alfa-2a, li huwa interferon li jaħdem fit-tul.
English: Uncommon side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 100 people) are:
Maltese: Effetti sekondarji mhux komuni bit-taħlita ta' Pegasys u ribavirin (jistgħu jaffettwaw sa persuna waħda minn kull 100) huma:
English: NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection Peginterferon alfa-2a
Maltese: Pegasys 180 mikrogramma soluzzjoni għall-injezzjoni Peginterferon alfa-2a
English: At Week 48 of Pegasys treatment, a height or weight percentile decrease of more than 15 percentiles on the normative growth curves was observed in 6% of patients for height and 11% of patient for weight, whereas in the untreated group it was 2% of patients for height and 9% for weight.
Maltese: F'Ġimgħa 48 ta' trattament b'Pegasys, kien osservat tnaqqis fil-perċentili tat-tul jew tal-piż ta' aktar minn 15-il perċentili fuq il kurvi tat-tkabbir normattiv f'6% tal-pazjenti għat-tul u fi 11% tal-pazjenti għall-piż, filwaqt li fil-grupp mhux ittrattat dan seħħ fi 2% tal-pazjenti għat-tul u f'9% tal-pazjenti għall-piż.
English: Caution should therefore be exercised when adding Pegasys and ribavirin to HAART therapy (see ribavirin SmPC).
Maltese: Għandu jkun hemm attenzjoni meta jiżdiedu Pegasys u ribavirin ma' terapija HAART (ara l-SmPC ta'
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED PENS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA - 12-IL PINNA MIMLIJA GĦAL-LEST x 180 µg
English: Prior to initiation of Pegasys therapy, TSH and T4 levels should be evaluated.
Maltese: Qabel ma tinbeda terapija b'Pegasys, il-livelli ta' TSH u T4 għandhom jiġu evalwati.
English: Table 5: Pegasys dose modification recommendations in paediatric patients with chronic hepatitis B or chronic hepatitis C Starting dose (mcg)
Maltese: Tabella 4: Rakkomandazzjonijiet ta' dożaġġ ta' Pegasys għall-pazjenti pedjatriċi b'epatite B kronika u b'epatite Ċ kronika Firxa tal-Erja tas-Superfiċje tal-Ġisem (BSA)
English: Overall treatment for 16 weeks resulted in lower sustained viral response (65%) than treatment for 24 weeks (76%) (p < 0.0001).
Maltese: Kura totali għal 16-il ġimgħa wasslet għal rispons virali sostenut aktar baxx (65%) minn kura għal 24 ġimgħa (76%) (p < 0.0001).
English: There are no data on the effects of peginterferon alfa-2a on fertility in women.
Maltese: M'hemmx dejta dwar l-effetti ta' peginterferon alfa-2a fuq il-fertilità fin-nisa.
English: HBV genotype A B
Maltese: HBV taħt 10
English: Manufacturer Roche Pharma AG Emil-Barell-Str.1
Maltese: Manifattur Roche Pharma AG
English: Recommendations for dose modifications of Pegasys for toxicities in the CHB and CHC paediatric populations are presented in Table 6.
Maltese: Rakkomandazzjonijiet għal modifikazzjonijiet fid-doża ta' Pegasys minħabba effetti tossiċi fil popolazzjoni pedjatrika b'CHB u CHC huma ppreżentati fit-Tabella 6.
English: Additional testing should be performed periodically during therapy (including glucose monitoring).
Maltese: Testijiet oħra għandhom isiru perjodikament matul it-terapija (inkluż monitoraġġ tal-glucose).
English: Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml * Pegasys 180 mcg & ribavirin 800 mg vs. Interferon alfa-2a 3 MIU & ribavirin 800 mg: Odds Ratio (95% CI) = 5.40 (3.42 to 8.54), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0001 * Pegasys 180 mcg & ribavirin 800 mg vs. Pegasys 180 mcg:
Maltese: IU/ml; Viral load għolja = > 800,000 IU/ml * Pegasys 180 mcg & ribavirin 800 mg vs.
English: Exploratory analyses based on limited data show paediatric patients with greater decline in HBV-DNA at week 12 of therapy were more likely to achieve HBeAg seroconversion at 24 weeks of follow-up (Table 24).
Maltese: Analiżi esploratorja bbażata fuq dejta limitata turi li pazjenti pedjatriċi bi tnaqqis ikbar fid-DNA ta' HBV f'Ġimgħa 12 tat-terapija kienu aktar probabbli li jiksbu serokonverżjoni ta' HbeAg f'Ġimgħa 24
English: Lamivudine 100 mg (N=179)
Maltese: Ribavirin mg (N=444)
English: Plasma exposure of ribavirin did not appear to be affected by concomitant administration of nucleoside reverse transcriptase inhibitors (NRTIs).
Maltese: L-espożizzjoni fil-plażma ta' ribavirin ma deherx li kienet affettwata mill-għoti flistess ħin ta' inibituri ta' nucleoside reverse transcriptase (NRTIs - nucleoside reverse transcriptase inhibitors).
English: Hepatic neoplasm
Maltese: Pazjenti kollha
English: In a pharmacokinetic study of 24 HCV patients concomitantly receiving methadone maintenance therapy (median dose 95 mg; range 30 mg to 150 mg), treatment with Pegasys 180 micrograms sc once weekly for 4 weeks was associated with mean methadone levels that were 10% to 15% higher than at baseline.
Maltese: 180 mikrogramma sc darba fil-ġimgħa għal 4 ġimgħat kienet assoċjata ma' livelli medji ta' methadone li kienu 10% sa 15% ogħla mil-linja bażi.
English: 1 pre-filled syringe + 1 injection needle 135 micrograms/0.5 ml
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT soluzzjoni għall-injezzjoni pinna waħda mimlija għal-lest 135 mikrogramma/0.5 ml
English: In the NV17424 (PEDS-C) study, previously untreated paediatric patients 5 to 17 years of age (55% <12 years old) with compensated CHC and detectable HCV RNA were treated with Pegasys 180 mcg x BSA/1.73 m2 once weekly for 48 weeks with or without ribavirin 15 mg/kg/day.
Maltese: (PEDS-C), pazjenti pedjatriċi li qatt ma ħadu kura qabel b'età minn 5 snin sa 17il sena (55% b'età <12-il sena) b'CHC ikkumpensata u b'RNA ta' HCV li setgħet tiġi osservata kienu kkurati b'Pegasys 180 mcg x BSA/1.73 m2 darba fil-ġimgħa għal 48 ġimgħa flimkien ma' jew mingħajr ribavirin 15 mg/kg/jum.
English: At 2 years posttreatment, 16% (6 of 38) of patients remained 15 percentiles or more below their baseline weight curve and 11% (4 of 38) remained 15 percentiles or more below their baseline height curve.
Maltese: Sentejn wara t-trattament, 16% (6 minn 38) tal-pazjenti baqgħu 15-il perċentili jew aktar taħt il-kurva tal-piż fil-linja bażi tagħhom u 11% (4 minn 38) baqgħu 15-il perċentili jew aktar taħt il-kurva tat-tul fil-linja bażi tagħhom.
English: Dose-response in monotherapy
Maltese: Rispons għad-doża fil-monoterapija
English: The virological responses of patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load for HIV-HCV coinfected patients are summarised below in Table 21.
Maltese: Tul tat-terapija meta Pegasys jintuża flimkien ma' prodotti mediċinali oħrajn Irreferi wkoll għas-Sommarju tal-Karatteristiċi tal-Prodott tal-prodotti mediċinali li jintużaw flimkien ma' Pegasys.
English: Paediatric patients treated with Pegasys plus ribavirin combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline.
Maltese: Pazjenti pedjatriċi ttrattati b'terapija kkombinata ta' Pegasys flimkien ma' ribavirin urew ittardjar fiż-żidiet fil-piż u t-tul wara 48 ġimgħa ta' terapija meta mqabbel mal-linja bażi.
English: At the end of 2 years follow-up after treatment, most patients had returned to baseline normative growth curve percentiles for weight and height (mean weight percentile was 64% at baseline and 60% at 2 years post-treatment; mean height percentile was 54% at baseline and 56% at 2 years post-treatment).
Maltese: Fi tmiem is-segwitu ta' sentejn wara t-trattament, il-biċċa l-kbira tal-pazjenti kienu reġgħu lura għall-perċentili normattivi tal-kurva tat tkabbir għall-piż u t-tul fil-linja bażi (il-perċentili tal-piż medju kien ta' 64% fil-linja bażi u 60% sentejn wara t-trattament; il-perċentili tat-tul medju kien ta' 54% fil-linja bażi u 56% sentejn wara t trattament).
English: Wash your hands well using soap and water.
Maltese: Aħsel idejk sew bl-użu ta' sapun u ilma.
English: Disposal of the injection materials
Maltese: nekrolisi tossika talepidermide,
English: Thyroid function abnormalities or worsening of pre-existing thyroid disorders have been reported with the use of alfa interferons, including Pegasys.
Maltese: Sistema endokrinarja Kienu rrappurtati anormalitajiet fil-funzjoni tat-tirojde jew irkadar ta' mard tat-tirojde eżistenti minn qabel waqt l-użu ta' alfa interferons, inkluż Pegasys.
English: Multiple regression and pooled group analyses evaluating the influence of treatment duration and use of induction dosing clearly identified treatment duration for 72 weeks as the primary driver for achieving a sustained virological response.
Maltese: Analiżi ta' regressjoni multipla u analiżi miġbura ta' gruppi li vvalutaw l-influwenza tat-tul tal-kura u l-użu ta' dożaġġ ta' induzzjoni identifikaw b'mod ċar tul ta' kura ta' 72 ġimgħa bħala l-induttur prinċipali biex jintlaħaq rispons viroloġiku sostenut.
English: 500 to < 750 cells/mm 3: Immediate 1 level adjustment.
Maltese: 500 sa < 750 ċellula/mm3: Aġġustament immedjat ta' livell wieħed.
English: Results from pharmacokinetic substudies of pivotal phase III trials demonstrated no pharmacokinetic interaction of lamivudine on Pegasys in HBV patients or between Pegasys and ribavirin in HCV patients.
Maltese: III ma wrew l-ebda interazzjoni farmakokinetika ta' lamivudine fuq Pegasys f'pazjenti b'HBV jew bejn Pegasys u ribavirin f'pazjenti b'HCV.
English: In another clinical trial, non-responder patients with advanced fibrosis or cirrhosis (Ishak score of 3 to 6) and baseline platelet counts as low as 50,000 cells/mm3 were treated for 48 weeks.
Maltese: Fi prova klinika oħra, pazjenti b'fibrożi avanzata jew ċirrożi li ma rrispondewx (punteġġ Ishak ta' 3 sa 6) u għadd tal-plejtlits fil-linja bażi baxx sa 50,000 ċellula/mm3 kienu kkurati għal 48 ġimgħa.