FrancophonIA/ELRC3.0 huggingface dataset:
English: In subjects treated with boceprevir who did not achieve SVR and with post-baseline samples analysed for RAVs, interferon responsiveness was associated with detection of fewer RAVs, with 31% of these subjects having post-baseline RAVs compared to 69% of subjects with < 1-log10 decline in viral load at Treatment Week 4.
Maltese: F'individwi kkurati b'boceprevir li ma kisbux SVR u b'kampjuni ta' wara l-linja bażi analizzati għal RAVs, rispons għal interferon kien assoċjat mal-kejl ta' inqas RAVs, b'31% ta' dawn l-individwi li nstab li kellhom RAVs wara l-linja bażi meta mqabbla ma' 69% tal-individwi bi tnaqqis ta' < 1-log10 fit-tagħbija virali fil-Ġimgħa ta' Kura 4.
English: • Co-administration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as orally administered midazolam and triazolam, bepridil, pimozide, lurasidone, lumefantrine, halofantrine, tyrosine kinase inhibitors, simvastatin, lovastatin, quetiapine, alfuzosin, silodosin, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine,
Maltese: • F'għoti flimkien ma' mediċini li jiddependu ħafna minn CYP3A4/5 għat-tneħħija tagħhom, u li konċentrazzjonijiet għolja tagħhom fil-plażma huma assoċjati ma' każijiet serji u/jew ta' periklu għall-ħajja bħal midazolam u triazolam mogħtija mill-ħalq, bepridil, pimozide, lurasidone, lumefantrine, halofantrine, inibituri ta' tyrosine kinase, simvastatin, lovastatin, quetiapine, alfuzosin, silodosin, u derivattivi ta' ergot (dihydroergotamine, ergonovine, ergotamine,
English: Diarrhoea*, nausea*, vomiting* dry mouth, dysgeusia Abdominal pain*, abdominal pain upper*, constipation*, gastrooesophageal reflux disease*, haemorrhoids*, abdominal discomfort, abdominal distention, anorectal discomfort, aphthous stomatitis, cheilitis, dyspepsia, flatulence, glossodynia, mouth ulceration, oral pain, stomatitis, tooth disorder
Maltese: Dijarea*, nawsja*, rimettar*, ħalq xott, disgewżja Uġigħ fl-addome*, uġigħ fin-naħa ta' fuq tal-addome*, stitikezza*, mard ta' rifluss gastroesofagali*, murliti*, skonfort fl-addome, nefħa fl-addome, skonfort fl-anus u r-rektum, stomatite bl-afte, kajlite, dispepsja, gass, glossodinja, ulċeri fil-ħalq, uġigħ fil-ħalq, stomatite,
English: The data available (see section 5.3) warrant caution in patients at risk of QT prolongation (long
Maltese: Id-dejta disponibbli (ara sezzjoni 5.3) teħtieġ kawtela f'pazjenti li għandhom riskju ta' titwil ta' QT
English: No dose adjustment of buprenorphine/naloxone or Victrelis is recommended.
Maltese: Ma huwa rakkomandat lebda aġġustament fid-doża ta' buprenorphine/naloxone jew Victrelis.
English: Caution should be exercised with medicines known to prolong QT interval such as amiodarone, quinidine, methadone, pentamidine and some neuroleptics.
Maltese: Għandu jkun hemm kawtela b'mediċini magħrufin li jtawlu l-intervall QT bħal amiodarone, quinidine, methadone, pentamidine u xi newrolettiċi.
English: ANTI-INFECTIVES Antifungals
Maltese: KONTRAĊETTIVI ORALI
English: • medicine used to decrease blood pressure - calcium channel blockers (e.g., amlodipine,
Maltese: • mediċina użata biex tbaxxi l-pressjoni tad-demm - imblokkaturi tal-kanali tal-kalċju (eż,
English: Boceprevir has not been studied in patients with decompensated cirrhosis (see section 5.2).
Maltese: Boceprevir ma kienx studjat f'pazjenti b'ċirrożi mhux ikkumpensata (ara sezzjoni 5.2).
English: Neutropenia
Maltese: Koorti
English: Platelet counts were decreased for subjects in the Victrelis containing-arms (3%) compared to subjects receiving peginterferon alfa-2b and ribavirin alone (1%).
Maltese: L-għadd tal-plejtlits kien aktar baxx f'pazjenti li kienu f'fergħat li kien fihom Victrelis (3%) meta mqabbel ma' individwi li kienu qed jirċievu peginterferon alfa-2b u ribavirin biss (1%).
English: A greater than 10-fold reduction in boceprevir susceptibility was conferred by the amino acid substitutions R155T and A156S.
Maltese: Is-sostituzzjonijiet R155T u A156S tal-aċidu amminiku naqqsu ssuxxettibilità għal boceprevir b'aktar minn 10 darbiet.
English: 938/non-Black and Cohort 2 /Black N=159) and stratified by HCV genotype (1a or 1b) and by HCVRNA viral load (≤ 400,000 IU/mL vs. > 400,000 IU/mL) to one of the following three treatment arms:
Maltese: L-individwi kienu magħżula b'mod każwali fi proporzjon ta' 1:1:1 f'żewġ koorti (Grupp 1 N=938/mhux Suwed u Grupp 2/Suwed N=159) u maqsuma fi klassijiet skont il-ġenotip ta' HCV (1a jew 1b) u skont it-tagħbija virali tal-RNA ta' HCV (≤ 400,000 IU/mL vs. > 400,000 IU/mL) għal wieħed mit-tliet fergħat ta' kura:
English: C-boceprevir, the most abundant circulating metabolites were a diasteriomeric mixture of ketone-reduced metabolites with a mean exposure approximately 4 fold greater than that of boceprevir.
Maltese: C, l-aktar metaboliti abbundanti li jiċċirkolaw kienu taħlita diasterjomerika ta' metaboliti mnaqqsa minn ketone b'esponiment medju ta' madwar 4 darbiet aktar minn dak ta' boceprevir.
English: Seven percent of subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin had neutrophil counts of < 0.5 x 10
Maltese: Sebgħa fil-mija tal-individwi li kienu qed jirċievu t-taħlita ta' Victrelis ma' peginterferon alfa-2b u ribavirin kellhom għadd ta' newtrofili ta' < 0.5 x 10
English: Coadministration of quetiapine with Victrelis is contraindicated (see section 4.3).
Maltese: L-għoti flistess ħin ta' quetiapine ma' Victrelis huwa kontraindikat (ara sezzjoni 4.3).
English: A 3-year follow-up study of subjects who achieved SVR with a Victrelis-based regimen showed that > 99% (693/696) of patients maintained their SVR (no relapse) through the available follow-up period
Maltese: Studju ta' segwitu ta' 3 snin ta' individwi li kisbu SVR b'reġimen abbażi ta' Victrelis wera li > 99% (693/696) tal-pazjenti żammew l-SVR tagħhom (l-ebda rikaduta) matul il-perjodu ta' segwitu
English: Boceprevir has a mean total body clearance (CL/F) of approximately 161 l/hr.
Maltese: Boceprevir għandu tneħħija medja totali mill-ġisem (CL/F) ta' madwar 161 l/siegħa.
English: • Victrelis is always taken in combination with peginterferon alfa and ribavirin.
Maltese: • Victrelis dejjem jittieħed flimkien ma' peginterferon alfa u ribavirin.
English: If haemoglobin is < 10 g/dL (or < 6.2 mmol/L) management of anaemia may be warranted (see
Maltese: Jekk l-emoglobina fisserum hija ta' < 10 g/dL (jew <6.2 mmol/L) għandu mnejn ikun meħtieġ l-immaniġġar tal-anemija
English: **** Partial Responder: subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa-2b and ribavirin, but demonstrated a ≥ 2 log10 reduction in HCVRNA by Week 12 and had detectable HCV-RNA at End of Treatment (EOT).
Maltese: **** Persuna b'Rispons Parzjali: individwu li ma kisibx SVR wara mill-inqas 12-il ġimgħa ta' kura li ngħatat qabel b'peginterferon alfa u ribavirin, iżda wera tnaqqis ta' ≥ 2 log10 fl-RNA ta' HCV sa Ġimgħa 12 u kellu RNA ta' HCV rilevabbli fit-Tmiem tal-Kura (EOT).
English: (CYP3A induction - effect on
Maltese: (Inibizzjoni ta' CYP3A - effett
English: At steady-state, the exposure ratio for the two diastereomers is approximately 2:1, with the predominant diastereomer being pharmacologically active.
Maltese: Fi stat fiss, il-proporzjon ta' esponiment għaż-żewġ dijasterjomeri huwa ta' madwar 2:1, bid-dijasterjomeru predominanti attiv b'mod farmakoloġiku.
English: (CYP3A inhibition - effect on
Maltese: (inibizzjoni ta' CYP3A - effett
English: boceprevir AUC ↔ boceprevir Cmax ↓ 3%
Maltese: L-AUC ta' boceprevir ↔ Is-Cmax ta' boceprevir ↓ 3%
English: In clinical trials, HCV-RNA in plasma was measured with the Roche COBAS Taqman 2.0 assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
Maltese: Fi provi kliniċi, l-RNA ta' HCV fil-plażma kienet imkejjla bl-assaġġ Roche COBAS Taqman 2.0 b'limitu ta' kejl ta' 9.3 IU/mL u limitu ta' kwantifikazzjoni ta' 25 IU/mL.
English: RESPOND-2 (P05101) was a randomized, parallel-group, double-blinded study comparing two therapeutic regimens of Victrelis 800 mg orally three times daily in combination with PR [peginterferon alfa-2b 1.5 µg/kg/week subcutaneously and weight-based ribavirin (600 1,400 mg BID) orally divided twice daily] compared to PR alone in adult subjects with chronic hepatitis C HCV genotype 1 infection with demonstrated interferon responsiveness (as defined historically by a decrease in HCV-RNA viral load ≥ 2 log10 by Week 12 or undetectable HCV-RNA at end of prior treatment with a subsequent detectable HCV-RNA in plasma) and who failed prior treatment with peginterferon alfa and ribavirin.
Maltese: RESPOND-2 (P05101) kien studju każwali, double-blinded, bi grupp parallell li qabbel żewġ skedi terapewtiċi ta' Victrelis 800 mg mill-ħalq tliet darbiet kuljum flimkien ma' PR [peginterferon alfa-2b 1.5 µg/kg/ġimgħa taħt il-ġilda u doża ta' ribavirin skont il-piż (600 1,400 mg BID) mill-ħalq maqsuma f'darbtejn kuljum] imqabbel ma' PR biss f'individwi adulti li kellhom infezzjoni kronika blepatite Ċ ikkawżata minn HCV tal-ġenotip 1 li wrew rispons għal interferon (storikament iddefinit bħala tnaqqis ta' ≥ 2 log10 fit-tagħbija virali tal-RNA ta' HCV sa Ġimgħa 12 jew RNA ta' HCV li ma tistax titkejjel fit-tmiem ta' kura li ngħatat qabel, segwit b'RNA ta' HCV li setgħet titkejjel filplażma) u li kura li ħadu qabel b'peginterferon alfa u ribavirin ma ħadmitx fuqhom.
English: Among the 314 subjects, 230 were infected with genotype 1a HCV and 84 were infected with genotype 1b HCV. Seventy percent (70%) (162/230) of genotype 1a subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing.
Maltese: Fost it-314-il individwu, 230 kienu infettati bil-ġenotip 1a ta' HCV u 84 kienu infettati bil-ġenotip 1b ta' HCV.
English: ANTIPSYCHOTICS Quetiapine
Maltese: TAL-PRODOTT MEDIĊINALI
English: The race distribution of subjects was as follows: 84% white, 13% Black, 2% Asian, and 1% others.
Maltese: Id-distribuzzjoni tar-razza tal-individwi kienet kif ġejja: 84% bojod, 13% Suwed, 2% Asjatiċi, u 1% oħrajn.
English: No data are available; therefore, the combination of boceprevir with these medicines is not-recommended (see section 4.4).
Maltese: M'hemmx dejta disponibbli, għalhekk; kombinazzjoni ta' boceprevir ma' dawn il-mediċini mhux irrakkomandata (ara sezzjoni 4.4).
English: Croscarmellose sodium Pre-gelatinized starch Magnesium stearate
Maltese: Sodium lauryl sulfate Microcrystalline cellulose Lactose monohydrate
English: Victrelis must not be used by itself.
Maltese: Victrelis jista' jingħata ma' inibituri ta' AKR.
English: In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
Maltese: Fi provi kliniċi, l-RNA ta' HCV fil-plażma tkejlet b'assaġġ Roche COBAS Taqman b'limitu ta' kejl ta' 9.3 IU/mL u b'limitu ta' kwantifikazzjoni ta' 25 IU/mL.
English: (CYP3A inhibition - effect on quetiapine)
Maltese: (induzzjoni ta' CYP3A - effett fuq boceprevir)
English: This leaflet was last revised in {MM/YYYY}
Maltese: Deskrizzjoni ta' għażla ta' reazzjonijiet avversi
English: Boceprevir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, human peripheral blood lymphocyte and mouse micronucleus assays.
Maltese: Boceprevir ma kienx ġenotossiku f'sensiela ta' analiżi in vitro jew in vivo, li kienu jinkludu analiżi ta' mutazzjoni fil-ġeni tal-batterji, tal-limfoċiti tad-demm periferali uman u tal-mikronukleju tal-ġurdien.
English: A secondary analysis of subjects who received at least one dose of Victrelis or placebo after the four-week lead-in with peginterferon alfa-2b and ribavirin (ModifiedIntent-to-Treat population) demonstrated SVR rates in the combined cohort of 67% to 68% Victreliscontaining arms vs. 40% PR48 control.
Maltese: Analiżi sekondarja ta' individwi li rċevew mill-inqas doża waħda ta' Victrelis jew plaċebo wara l-perijodu ta' introduzzjoni ta' erba' ġimgħat b'peginterferon alfa-2b u ribavirin (Popolazzjoni Intenzjoni li Tikkura Mmodifikata) uriet rati ta' SVR fil-grupp imħallat ta' 67% sa 68% fil-fergħat li kien fihom Victrelis vs. 40% fil-kontroll PR48.
English: Not known (frequency cannot be estimated from the available data) Skin and hair: Severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung (a reaction called DRESS); serious skin reaction, including blistering or peeling of the skin (a reaction called Stevens-Johnson syndrome)
Maltese: Raxx sever, li jista' jkun akkumpanjat minn deni, għeja, nefħa fil-wiċċ jew filglandoli limfatiċi, żieda ta' esinofili (tip ta' ċelluli bojod tad-demm), effetti fuq il-fwied, ilkliewi jew il-pulmun (reazzjoni magħrufa bħala DRESS); reazzjoni serja tal-ġilda, inkluż infafet jew tqaxxir tal-ġilda (reazzjoni msejħa sindromu ta' Stevens-Johnson)
English: o Subjects with a detectable HCV-RNA at TW 8 but subsequently undetectable at TW 12 (late responders) were changed in a blinded fashion to placebo at the TW 36 visit and continued treatment with peginterferon alfa-2b + ribavirin for an additional 12 weeks, for a total treatment duration of 48 weeks.
Maltese: o Individwi b'RNA ta' HCV li setgħet titkejjel fi TW 8 iżda sussegwentement ma setgħetx titkejjel fi TW 12 (irrispondew tard) inqalbu b'mod blindfolded għal plaċebo fil-vista ta' TW 36 u komplew kura b'peginterferon alfa-2b + ribavirin għal 12-il ġimgħa oħra, għal tul ta' żmien totali ta' kura ta' 48 ġimgħa.
English: The Summary of Product Characteristics of peginterferon alfa and ribavirin (PR) must be consulted prior to initiation of
Maltese: Is-Sommarju tal-Karatteristiċi tal-Prodott ta' peginterferon alfa u ribavirin (PR) għandu jiġi kkonsultat qabel ma tinbeda terapija
English: Plasma concentrations of calcium channel blockers may increase when administered with Victrelis.
Maltese: Il-konċentrazzjonijiet talimblokkaturi tal-kanali tal-kalċju fil-plażma jistgħu jiżdiedu meta jingħataw ma' Victrelis.
English: Subjects randomized to receive ribavirin dose reduction (N=249)
Maltese: Individwi li ntgħażlu b'mod każwali biex jirċievu tnaqqis fid-doża ta' ribavirin (N=249)
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for baseline, ontreatment and post-treatment laboratory testing recommendations including haematology, biochemistry (including hepatic function tests), and pregnancy testing.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott għal peginterferon alfa u ribavirin għal rakkomandazzjonijiet ta' ttestjar tal-laboratorju tal-linja bażi ta' waqt il-kura u ta' wara l-kura inkluż ematoloġija, bijokimika (inkluż testijiet tal-funzjoni tal-fwied), u testijiet tat-tqala.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Thyroid neoplasm (nodules)
Maltese: Epiglottite*, otite tal-widna tan-nofs, sepsis Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Neoplażma fit-tirojde (għoqiedi żgħar)
English: • have low blood potassium (hypokalaemia)
Maltese: • għandek potassium fid-demm baxx (ipokalimja)
English: Gastroenteritis*, pneumonia*, staphylococcal infection*, candidiasis, ear infection, fungal skin infection, nasopharyngitis, onychomycosis, pharyngitis, respiratory tract infection, rhinitis, skin infection, urinary tract
Maltese: Gastroenterite*, pulmonite*, infezzjoni bl-istafilokokki*, kandidjasi, infezzjoni fil-widna, infezzjoni bil-moffa filġilda, nasofarinġite, moffa fid-dwiefer, farinġite, infezzjoni fil-passaġġ respiratorju, rinite, infezzjoni filġilda, infezzjoni fl-apparat tal-awrina
English: Goitre, hypothyroidism Hyperthyroidism
Maltese: Mediċini li fihom drospirenone
English: boceprevir AUC ↓ 5% boceprevir Cmax ↑ 4%
Maltese: L-AUC ta' boceprevir ↓ 5% Is-Cmax ta' boceprevir ↑ 4%
English: The Full Analysis Set (FAS) consisted of all randomized subjects (N=1,097) who received at least one dose of any study medicine (peginterferon alfa-2b, ribavirin, or Victrelis).
Maltese: Is-Sett Sħiħ ta' Analiżi (FAS) kien jikkonsisti fl-individwi magħżula b'mod każwali kollha (N=1,097) li rċevew mill-inqas doża waħda ta' kwalunkwe mediċina tal-istudju (peginterferon alfa2b, ribavirin, jew Victrelis).
English: • have ever had a blood problem such as neutropenia (lack of a certain type of white blood cells).
Maltese: • qatt kellek problema fid-demm bħal newtropenija (nuqqas ta' ċertu tip ta' ċelluli bojod tad-demm).
English: SPRINT-2 (P05216) was a randomized, double blinded, placebo-controlled study comparing two therapeutic regimens of Victrelis 800 mg orally three times daily in combination with PR [peginterferon alfa-2b 1.5 µg/kg/week subcutaneously and weight-based dosing with ribavirin (6001,400 mg/day orally divided twice daily)] to PR alone in adult subjects who had chronic hepatitis C HCV genotype 1 infection with detectable levels of HCV-RNA and were not previously treated with interferon alfa therapy.
Maltese: SPRINT-2 (P05216) kien studju każwali, double blinded, ikkontrollat bi plaċebo li qabbel żewġ skedi terapewtiċi ta' kura ta' Victrelis 800 mg mill-ħlaq tliet darbiet kuljum flimkien ma' PR [peginterferon alfa-2b 1.5 µg/kg/ġimgħa taħt il-ġilda u doża ta' ribavirin ibbażata fuq il-piż (600-1,400 mg/jum millħlaq maqsuma f'darbtejn kuljum)] ma' PR waħdu f'individwi adulti li kellhom infezzjoni kronika blepatite Ċ ikkawżata minn HCV tal-ġenotip 1 b'livelli ta' RNA ta' HCV li setgħu jitkejlu u li ma kinux ħadu kura qabel b'interferon alfa.
English: NN:
Maltese: Ftakar:
English: Outer carton with Blue Box
Maltese: Kartuna ta' barra bil-Kaxxa ċ-Ċelesti
English: The concomitant use of Victrelis with doxazosin and tamsulosin is not recommended (see section 4.5).
Maltese: Lużu fl-istess ħin ta' Victrelis ma' doxazosin u tamsulosin mhuwiex rakkomandat (ara sezzjoni 4.5).
English: • Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 44 weeks (Victrelis-PR48).
Maltese: • Peginterferon alfa-2b + ribavirin għal erba' ġimgħat segwit minn Victrelis 800 mg tliet darbiet kuljum + peginterferon alfa-2b + ribavirin għal 44 ġimgħa (Victrelis-PR48).
English: Table 5 presents sustained virologic response per treatment arm in previously untreated patients who were early responders and late responders and that received similar therapy up to treatment week 28.
Maltese: Tabella 5 turi rispons viroloġiku miżmum għall-kull fergħa ta' kura f'pazjenti li ma kienux ħadu kura qabel u li rrispondew malajr u f'dawk li kellhom rispons ittardjat u li rċievew terapija simili salġimgħa ta' kura 28.
English: All cirrhotic patients and null responders - Recommended treatment duration is 48 weeks: 4 weeks of bitherapy with peginterferon alfa+ ribavirin + 44 weeks of tritherapy with peginterferon alfa + ribavirin + Victrelis.
Maltese: 4 ġimgħat ta' terapija b'żewġ mediċini b'peginterferon alfa + ribavirin + 44 ġimgħa ta' terapija bi tliet mediċini b'peginterferon alfa + ribavirin + Victrelis.
English: A secondary analysis of subjects who received at least one dose of Victrelis or placebo after the four week lead-in with peginterferon alfa-2b and ribavirin (Modified-Intent-to-Treat population) demonstrated SVR rates of 61% to 67% in the Victreliscontaining arms compared to 22% PR48 control.
Maltese: Analiżi sekondarja ta' individwi li rċevew mill-inqas doża waħda ta' Victrelis jew plaċebo wara l-perijodu ta' introduzzjoni ta' erba' ġimgħat b'peginterferon alfa-2b u ribavirin (Popolazzjoni Intenzjoni li Tikkura Mmodifikata) uriet rati ta' SVR ta' 61% sa 67% filfergħat li kien fihom Victrelis meta mqabbla ma' 22% fil-kontroll PR48.
English: Merck Sharp & Dohme d.o.o.
Maltese: Merck Sharp & Dohme Ltd
English: (CYP3A inhibition and/or P-gp
Maltese: (inibizzjoni ta' CYP3A u/jew
English: Null responders (as defined historically by a decrease in HCV-RNA viral load < 2 log10 by Week 12 to prior therapy) were excluded.
Maltese: Dawk li ma rrispondew assolutament xejn (storikament iddefinit bħala tnaqqis ta' < 2 log10 fit-tagħbija virali talRNA ta' HCV sa Ġimgħa 12 għal kura li tkun ingħatat qabel) twarrbu mill-istudju.
English: While taking the combination of Victrelis with ribavirin and peginterferon alpha, serious allergic reactions have been reported.
Maltese: F'każijiet fejn Victrelis ittieħed flimkien ma' ribavirin u peginterferon alpha, ġew irrappurtati reazzjonijiet allerġiċi serji.
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' peginterferon alfa u ribavirin għal aktar
English: Discontinuation of therapy is recommended in all patients with 1) HCV-RNA levels of greater than or equal to 1,000 IU per mL at TW 8; or 2) HCV-RNA levels of greater than or equal to 100 IU per mL at TW 12; or 3) confirmed, detectable HCV-RNA levels at TW 24.
Maltese: It-twaqqif tat-terapija huwa rakkomandat fil-pazjenti kollha li għandhom 1) livelli ta' HCV-RNA ta' ogħla minn jew ugwali għal 1,000 IU għal kull mL fil-Ġimgħa ta' Kura 8; jew 2) livelli ta' HCV-RNA ogħla minn jew ugwali għal 100 IU kull ml fil-Ġimgħa ta' Kura 12; jew 3) livelli kkonfermati u traċċabbli ta' HCV-RNA fil-Ġimgħa ta' Kura 24.
English: • Detailed information about the risk of haematological disorders (notably anaemia) associated with Victrelis, consisting of factual description of the haematological disorders in terms of frequency and time to onset and related clinical symptoms
Maltese: • Informazzjoni dettaljata dwar ir-riskju ta' disturbi ematoloġiċi (l-aktar anemija) assoċjati ma' Victrelis, li tikkonsisti f'deskrizzjoni tal-fatti tad-disturbi ematoloġiċi f'dak li għandu x'jaqasm ma' frekwenza u kemm idumu biex jibdew u x'inhuma s-sintomi kliniċi
English: Patients should be monitored for signs of opiate toxicity associated with buprenorphine.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali ta' tossiċità ta' opiates assoċjata ma' buprenorphine.
English: The most common reason for dose reduction was anaemia, which occurred more frequently in subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin than in subjects receiving peginterferon alfa-2b and ribavirin alone.
Maltese: Ir-raġuni l-aktar komuni għal tnaqqis fid-doża kienet anemija, li seħħet b'mod aktar frekwenti f'individwi li kienu qed jirċievu l-kombinazzjoni ta' Victrelis ma' peginterferon alfa-2b u ribavirin milli f'individwi li kienu qed jirċievu peginterferon alfa-2b u ribavirin biss.
English: Sustained Virologic Response (SVR) in patients receiving similar therapy up to treatment week 28
Maltese: Rispons Viroloġiku Miżmum (SVR) f'pazjenti li kienu qed jirċievu terapija simili sa' ġimgħa 28
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose.
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' peginterferon alfa u ribavirin għal aktar informazzjoni dwar it-tnaqqis u/jew it-twaqqif tad-doża ta' peginterferon alfa u/jew ribavirin.
English: Boceprevir is eliminated with a mean plasma half-life (t½) of approximately 3.4 hours.
Maltese: Boceprevir jitneħħa mill-plażma b'half-life medja (t½) ta' madwar 3.4 sigħat.
English: When co-administration is required, starting with the lowest possible dose of atorvastatin should be considered with titration up to desired clinical effect while monitoring for safety, without exceeding a daily dose of 20 mg. For patients currently taking atorvastatin, the dose of atorvastatin should not exceed a daily dose of 20 mg during co-administration with Victrelis.
Maltese: Meta jkun meħtieġ l-għoti tagħhom flimkien, għandu jiġi kkunsidrat li tinbeda laktar doża baxxa possibbli ta' atorvastatin b'titrazzjoni sal-effett kliniku mixtieq filwaqt li jkun hemm monitoraġġ tas-sigurtà, mingħajr ma tinqabeż id-doża ta' kuljum ta' 20 mg.