FrancophonIA/ELRC3.0 huggingface dataset:
English: Indeed, serum progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels indicated that ovulation was suppressed during coadministration of norethindrone 1 mg/ethinyl estradiol 0.035 mg with Victrelis (see section 4.6).
Maltese: Fil-fatt, il-livelli ta' proġesteron fis-serum, lormon lutejnizzanti (LH) u l-ormon li jistimula lfollikoli (FSH) indikaw li l-ovulazzjoni kienet soppressa matul l-għoti flimkien ta' norethindrone 1 mg/ethinyl estradiol 0.035 mg ma' Victrelis (ara sezzjoni 4.6).
English: Boceprevir has been shown to be a p-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) substrate in vitro.
Maltese: Boceprevir intwera li huwa sottostrat ta' p-glycoprotein (P-gp) u tal-proteina reżistenti għall-kanċer tas-sider (BCRP) in vitro.
English: Clear polychlorotrifluoroethylene /PVC/aluminium blisters containing 4 hard capsules per blister cavity.
Maltese: Folji trasparenti magħmula minn polychlorotrifluoroethylene/PVC/aluminju li fihom 4 kapsuli ibsin f'kull ħofra tal-folja.
English: The D168V single substitution did not reduce sensitivity to boceprevir.
Maltese: Is-sostituzzjoni unika D168V ma naqqsitx is-sensittività għal boceprevir.
English: Caution should be exercised when boceprevir is combined with ketoconazole or azole antifungals (itraconazole, posaconazole, voriconazole).
Maltese: Għandu jkun hemm kawtela meta boceprevir titħallat ma' ketoconazole jew ma' sustanzi azole kontra l-moffa (itraconazole, posaconazole, voriconazole).
English: Within each system organ class, adverse reactions are listed under headings of frequency using the categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data).
Maltese: F'kull klassi ta' sistemi u organi, ir-reazzjonijiet avversi huma elenkati taħt it-titli ta' frekwenza bl-użu talkategoriji: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Victrelis is partly metabolized by CYP3A4/5.
Maltese: Victrelis huwa mmetabolizzat parzjalment minn CYP3A4/5.
English: Alopecia, dry skin, pruritus, rash
Maltese: Alopeċja, ġilda xotta, ħakk, raxx
English: tacrolimus AUC ↑ 1610% tacrolimus Cmax ↑ 890%
Maltese: L-AUC ta' tacrolimus ↑ 1,610% Is-Cmax ta' tacrolimus ↑ 890%
English: Subjects were randomized in a 2:1 ratio and stratified based on cirrhosis/fibrosis and baseline HCV-RNA (< 800,000 IU/mL vs. ≥ 800,000 IU/mL).
Maltese: Lindividwi kienu randomizzati fi proporzjon ta' 2:1 u stratifikati fuq il-bażi ta' ċirrożi/fibrożi u HCV-RNA fil-linja bażi (< 800,000 IU/mL vs. ≥ 800,000
English: SVR rates with “missing=failure” approach were 17/80 [21.3%] for PR48, 94/162 [58.0%] for Victrelis-RGT,
Maltese: Ir-rati ta' SVR affrontat b'mod ta' “nieqes=ma ħadimx” kienu 17/80 [21.3%] għal PR48, 94/162 [58.0%] għal Victrelis-RGT, 106/161 [65.8%] għal Victrelis-PR48.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE12
Maltese: Kategorija farmakoterapewtika: antivirali għal użu sistemiku, inibituri tal-protease, Kodiċi ATC:
English: Combined use with peginterferon alfa-2a see specific section in section 4.4.
Maltese: Użu flimkien ma' peginterferon alfa-2a ara s-sezzjoni speċifika f'sezzjoni 4.4.
English: The concomitant use of Victrelis with potent CYP3A4 inducers (rifampicin, carbamazepine, phenobarbital, phenytoin) is not recommended (see section 4.5).
Maltese: L-użu ta' Victrelis flimkien ma' indutturi qawwija ta' CYP3A4 (rifampicin, carbamazepine, phenobarbital, phenytoin) mhux irrakkomandat (ara sezzjoni 4.5).
English: Mean age of subjects randomized was 43.6 years.
Maltese: Letà medja tal-individwi randomizzati kienet ta' 43.6 snin.
English: Table 11 Sustained Virologic Response (SVR) * and Relapse
Maltese: Tabella 11 Rispons Viroloġiku Miżmum (SVR - Sustained Virologic Response) * u Rati ta' Irkadar
English: Dermatitis, eczema, erythema, hyperhidrosis, night sweats, oedema peripheral, psoriasis, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, skin lesion
Maltese: Dermatite, ekżema, eritema, għaraq eċċessiv, għaraq billejl, edima periferali, psorijasi, raxx bil-ħmura, raxx makulari, raxx makulopapulari, raxx papulari, raxx bilħakk, leżjonijiet fil-ġilda
English: *Please see section 5.1 clinical trial descriptions for each treatment arm.
Maltese: *Jekk jogħġbok ara sezzjoni 5.1 deskrizzjonijiet tal-prova klinika għall-kull fergħa ta' kura
English: • select statins - atorvastatin or pravastatin
Maltese: • statins magħżula - atorvastatin jew pravastatin
English: Recommendations concerning co-administration buprenorphine AUC ↑ 19%
Maltese: Analġeżiċi narkotiċi/Dipendenza fuq Opjojdi buprenorphine AUC ↑ 19%
English: Tacrolimus* (tacrolimus 0.5 mg single dose + Victrelis 800 mg single dose)
Maltese: Tacrolimus* (tacrolimus 0.5 mg doża waħda + Victrelis 800 mg doża waħda)
English: Boceprevir, in combination with peginterferon alfa and ribavirin, was evaluated in a total of 98 patients (64 in the boceprevir arm) co-infected with Human Immunodeficiency Virus (HIV) and HCV genotype 1 who were previously untreated for chronic HCV infection (see section 4.8 and 5.1).
Maltese: Boceprevir, f'kombinazzjoni ma' peginterferon alfa u ribavirin, ġie evalwat f'total ta' 98 pazjent (64 fil-grupp li ħa boceprevir) ko-infettati bil-Virus tal-Immunodefiċjenza Uman (HIV) u bil-ġenotip 1 tal-HCV li qabel ma kinux ingħataw kura għal infezzjoni kronika tal-HCV (ara sezzjoni 4.8 u 5.1).
English: In a genotype 1a replicon, the IC50 and IC90 values for boceprevir were 900 nM and 1,400 nM, respectively.
Maltese: F'element ġenetiku ta' ġenotip 1a li jirreplika bħala unità awtonoma, ilvaluri IC50 u IC90 ta' boceprevir kienu 900 nM u 1,400 nM, rispettivament.
English: Neuropathy peripheral*, cognitive disorder, hyperaesthesia, lethargy, loss of consciousness, mental impairment, neuralgia, presyncope
Maltese: Newropatija periferali*, disturb konoxxittiv, iperestesija, letarġija, telf mis-sensi, indeboliment mentali, nevralġija, presinkope
English: • pimozide or lurasidone - used for mental health problems
Maltese: • pimozide jew lurasidone - jintuża għal problemi ta' saħħa mentali
English: Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with Victrelis, peginterferon alfa, and ribavirin.
Maltese: Reazzjonijiet ta' sensittività eċċessiva akuta u serja (eż. urtikarja, anġjoedema) ġew osservati matul terapija kombinata b'Victrelis, peginterferon alfa, u ribavirin.
English: HCV-RNA levels should be monitored at Treatment Weeks 8, 12, and 24, and for other time points as
Maltese: HCV-RNA għandhom jiġu mmonitorjati fil-Ġimgħat 8, 12, u 24 ta' kura u għal punti ta'
English: Each hard capsule contains 200 mg boceprevir.
Maltese: Kull kapsula iebsa fiha 200 mg boceprevir.
English: ethinyl estradiol AUC ↓ 24% ethinyl estradiol Cmax ↔
Maltese: L-AUC ta' ethinyl estradiol ↓ 24% Is-Cmax ta' ethinyl estradiol ↔
English: HMG CoA REDUCTASE INHIBITORS Atorvastatin* (atorvastatin 40 mg single dose + Victrelis 800 mg three times daily)
Maltese: INIBITURI TA' HMG CoA REDUCTASE Atorvastatin* (atorvastatin 40 mg doża waħda + Victrelis 800 mg tliet darbiet kuljum)
English: All subjects n=368
Maltese: L-individwi kollha n=368
English: A genetic variant near the gene encoding interferon-lambda-3 (IL28B rs12979860, a C to T change) is a strong predictor of response to peginterferon alfa-2b/ribavirin.
Maltese: Varjant ġenetiku qrib il-ġene li tenkowdja interferon-lambda-3 (IL28B rs12979860, bidla minn C għal T) jgħin ħafna biex jitbassar ir-rispons għal peginterferon alfa-2b/ribavirin.
English: • medicine used to treat symptoms of an enlarged prostate - doxazosin and tamsulosin
Maltese: • mediċina użata biex tikkura sintomi ta' prostata minfuħa - doxazosin u tamsulosin
English: Victrelis contains lactose
Maltese: Victrelis fih lactose
English: The use of erythropoesis stimulating agents was associated with an increased risk of thromboembolic events including pulmonary embolism, acute myocardial infarction, cerebrovascular accident, and
Maltese: L-użu ta' sustanzi li jistimulaw l-eritropoesi kien assoċjat ma' żieda fir-riskju ta' avvenimenti tromboemboliċi inkluż emboliżmu fil-pulmun, infart mijokardijaku akut, inċident ċerebrovaskulari, u
English: The activity of boceprevir against the HCV genotype 1a replicon was reduced (2- to 6-fold) by the following amino acid substitutions in the NS3 protease domain: V36A/L/M, Q41R, T54A/S, V55A, R155K and V158I.
Maltese: L-attività ta' boceprevir kontra r-replika tal-HCV tal-ġenotip 1a tnaqqset (2- sa 6 darbiet) missostituzzjonijiet li ġejjin tal-aċidu amminiku fil-qasam tal-protease NS3: V36A/L/M, Q41R, T54A/S, V55A, R155K u V158I .
English: (tacrolimus 0.5 mg single dose + Victrelis 800 mg three times daily multiple doses)
Maltese: (tacrolimus 0.5 mg doża waħda + Victrelis 800 mg dożi multipli tliet darbiet kuljum)
English: Mean age of subjects randomized was 49.1 years.
Maltese: L-età medja tal-individwi magħżula b'mod każwali kienet ta' 49.1 sena.
English: Hypoaesthesia*, paraesthesia*, syncope*, amnesia, disturbance in attention, memory impairment, migraine, parosmia, tremour, vertigo
Maltese: Ipoestesija *, paresteżija*, sinkope*, amnesija, disturb flattenzjoni, indeboliment tal-memorja, emigranja, parosmija, rogħda, vertiġini
English: For data regarding drug-drug interactions with antiretroviral agents, see section 4.5.
Maltese: Għal dejta dwar interazzjonijiet bejn mediċina u oħra b'sustanzi antiretrovirali, ara sezzjoni 4.5.
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Maltese: Pazjenti li jużaw lestroġeni bħala terapija ta' sostituzzjoni tal-ormoni għandhom jiġu mmonitorjati klinikament għal sinjali ta' defiċjenza ta' estroġenu.
English: %, (n/N) 69 (72/105) 75 (77/103) EOT % (n/N) 79 (83/105) 86 (89/103)
Maltese: (31/57) 60 (35/58) 10 (3/29) %, (n/N) %, (n/N) 69 (72/105) 75 (77/103) 29 (15/51) EOT % (n/N) 79 (83/105) 86 (89/103) 43 (22/51) %, (n/N) 14 (12/83)
English: Data obtained in juvenile rats suggest that the pharmacokinetic profile of boceprevir may be different than in adult rats, possibly due to immaturity of some metabolic pathways.
Maltese: Dejta miksuba minn firien ġovanili tindika li l-profil farmakokinetiku ta' boceprevir jista' jkun differenti minn dak ta' firien adulti, possibbilment minħabba n-nuqqas ta' maturità ta' xi passaġġi metaboliċi.
English: Anaemia was observed in 49% of subjects treated with the combination of Victrelis with peginterferon alfa-2b and ribavirin compared with 29% of subjects treated with peginterferon alfa-2b and ribavirin alone.
Maltese: Anemija kienet osservata f'49% tal-individwi kkurati bil-kombinazzjoni ta' Victrelis ma' peginterferon alfa-2b u ribavirin meta mqabbla ma' 29% tal-individwi kkurati b'peginterferon alfa-2b u ribavirin biss.
English: Lopinavir/Ritonavir* (lopinavir 400 mg / ritonavir 100 mg two times daily + Victrelis 800 mg three times daily)
Maltese: Darunavir/Ritonavir* (darunavir 600 mg / ritonavir 100 mg darbtejn kuljum + Victrelis 800 mg tliet darbiet kuljum)
English: Interferon-responsiveness (as defined by ≥ 1-log10 decline in viral load at TW 4) was predictive of SVR.
Maltese: Rispons għal interferon (definit bħala tnaqqis ta' ≥ 1-log10 fit-tagħbija virali fi TW 4) kien ibassar lSVR.
English: The V55I and D168N single substitutions did not reduce sensitivity to boceprevir.
Maltese: Is-sostituzzjonijiet uniċi V55I u D168N ma naqqsux is-sensittività għal boceprevir.
English: • hormonal replacement therapy - oestrogen-based medicines
Maltese: • terapija ta' sostituzzjoni tal-ormoni - mediċini bbażati fuq l-estroġenu
English: Victrelis, in combination with peginterferon alfa and ribavirin, is contraindicated when coadministered 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, methylergonovine) (see section 4.3).
Maltese: Victrelis, flimkien ma' peginterferon alfa u ribavirin, huwa kontra-indikat meta jingħata flimkien ma' mediċini li huma dipendenti ħafna fuq 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, methylergonovinemine) (ara sezzjoni 4.3).
English: • are taking bepridil, pimozide, lurasidone, oral midazolam, oral triazolam, simvastatin, lovastatin, alfuzosin, silodosin, 'ergot' type medicines (such as dihydro-ergotamine, ergonovine, ergotamine or methylergonovine), lumefantrine, halofantrine, quetiapine, or tyrosine kinase inhibitors.
Maltese: • qed tieħu bepridil, pimozide, lurasidone, midazolam mill-ħalq, triazolam mill-ħalq, simvastatin, lovastatin, alfuzosin, silodosin, mediċini tat-tip ergot (bħal ma huma dihydro-ergotamine, ergonovine, ergotamine jew methylergonovine), lumefantrine, halofantrine, quetiapine jew impedituri ta' tyrosine kinase.
English: Table 6 Sustained Virologic Response (SVR)*, End of Treatment (EOT) and HCV Relapse Rates
Maltese: Tabella 6 Rispons Viroloġiku Miżmum (SVR)*, Tmiem tal-Kura (EOT) u Rati ta' Irkadar tal-HCV
English: Date of first authorisation: 18 July 2011 Date of latest renewal: 18 February 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Lulju 2011
English: • Store in a refrigerator (2C - 8C) until expiry.
Maltese: • Aħżen fi friġġ (2C - 8C) sakemm jiskadi.
English: o Subjects with undetectable HCV-RNA at TW 8 (early responders) and TW 12
Maltese: o Individwi b'RNA ta' HCV li ma setgħetx titkejjel fi TW 8 (rrispondew malajr) u TW 12
English: The IC50 and IC90 values for boceprevir against different genotype 1b replicons ranged from 200 to 600 nM and 400 to 900 nM, respectively, in a 72-hour cell culture assay.
Maltese: Il-valuri IC50 u IC90 għal boceprevir kontra element ġenetiku ta' ġenotip 1b differenti li jirreplika bħala unità awtonoma kellhom firxa minn 200 sa 600 nM u 400 sa 900 nM, rispettivament, f'analiżi ta' koltura ta' ċelluli ta' 72 siegħa.
English: In an in vitro dog Purkinje fiber study, boceprevir prolonged the action potential duration with inverse frequency dependence; the clinical relevance remains uncertain.
Maltese: Fi studju in vitro fuq fibri Purkinje tal-klieb, boceprevir tawwal it-tul tal-action potential b'dipendenza tal-frekwenza riversata; ir-rilevanza klinika tibqa dubjuża.
English: No clinical paediatric exposure data is available (see section 4.2).
Maltese: M'hemmx dejta klinika dwar l-esponiment pedjatriku (ara sezzjoni 4.2).
English: • warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Maltese: • warfarin u mediċini simili oħrajn imsejħa antagonisti tal-vitamina K użati biex iraqqu d-demm.
English: Photosensitivity reaction, skin ulcer, urticaria (see section 4.4)
Maltese: Reazzjoni ta' sensittività għad-dawl, ulċera fil-ġilda, urtikarja (ara sezzjoni 4.4)
English: • tyrosine kinase inhibitors - used as anti-cancer medicines
Maltese: • inibituri ta' tyrosine kinase - jintużaw bħala mediċini kontra l-kanċer
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku
English: In subjects who demonstrated interferon responsiveness by TW 4, treatment with the combination of Victrelis with peginterferon alfa-2b and ribavirin resulted in SVR rates of 79-81%, compared to 51% in subjects treated with standard of care.
Maltese: F'individwi li wrew rispons għal interferon sa TW 4, kura bit-taħlita ta' Victrelis ma' peginterferon alfa-2b u ribavirin wasslet għal rati ta' SVR ta' 79-81%, mqabbla ma' 51% f'individwi ikkurati b'kura standard.
English: Kidney: renal impairment (generally reversible after conclusion of treatment)
Maltese: Kliewi: indeboliment renali (ġeneralment riversibbli wara li titlesta l-kura)
English: Erectile dysfunction Amenorrhoea, menorrhagia, metrorrhagia
Maltese: Amenorreja, menorraġja, metrorraġja
English: The race distribution of subjects was as follows: 82% White, 14% Black, 2% Asian, 1% multiracial, 1% American Indian or Alaskan Native.
Maltese: Id-distribuzzjoni tar-razza tal-individwi kienet kif ġej: 82% Bojod, 14% Suwed, 2% Asjatiċi, 1% taħlita ta' razez, 1% Indjani Amerikani jew Indiġeni tal-Alaska.
English: RAVs were detected in 8% of patients at baseline by population sequencing.
Maltese: RAVs instabu fi 8% tal-pazjenti fil-linja bażi skont is-sekwenzar tal-popolazzjoni.
English: Victrelis was associated with an additional decrease of approximately 1 g/dL in haemoglobin concentration (see section 4.4).
Maltese: Victrelis kien assoċjat ma' tnaqqis addizzjonali ta' madwar 1 g/dL fil-konċentrazzjoni tal-emoglobina (ara sezzjoni 4.4).
English: Cerebral ischaemia*, encephalopathy
Maltese: Iskemija fil-moħħ*, enċefalopatija
English: The most frequently (> 25% of subjects) detected post-baseline RAVs in these subjects were amino acid substitutions V36M (61%) and R155K (68%) in subjects infected with genotype 1a viruses and T54A (42%), T54S (37%), A156S (26%) and V170A (32%) in subjects infected with genotype 1b
Maltese: L-aktar RAVs ta' wara l-linja bażi li setgħu jitkejlu b'mod frekwenti (>25% tal-individwi) f'dawn l-individwi kienu sostituzzjonijiet V36M(61%) u R155K (68%) tal-aċidu amminiku f'individwi infettati bil-virus ta' ġenotip 1a u sostituzzjonijiet T54A (42%), T54S (37%), A156S (26%) u V170A (32%) f'individwi infettati bil-virusis ta' ġenotip 1b.
English: Table 3 Adverse reactions in combination with Victrelis with peginterferon alfa-2b and ribavirin reported during clinical trials
Maltese: Tabella 3 Reazzjonijiet avversi ta' Victrelis flimkien ma' peginterferon alfa-2b u ribavirin irrappurtati waqt provi kliniċi
English: Peelable blisters containing 12 hard capsules (3x4 capsule blister strip).
Maltese: Folji li jitqaxxru li fihom 12-il kapsula iebsa (strixxa ta' folja ta' 3x4 kapsuli).
English: T/T
Maltese: IL-PROVVISTA U L
English: • ‘ergot' type medicines, such as dihydro-ergotamine, ergonovine, ergotamine or methylergonovine - used for migraine and cluster headaches
Maltese: • mediċini tat-tip ‘ergot', bħal ma huma dihydro-ergotamine, ergonovine, ergotamine jew methylergonovine - jintużaw għall-emigranja u episodji ta' uġigħ ta' ras frekwenti
English: A study with peginterferon alfa-2a in treatment experienced patients gave consistent results as compared to the study P05101 (see section 4.4).
Maltese: Studju b'peginterferon alfa-2a fuq pazjenti li għandhom esperjenza tal-kura ta riżultati konsistenti meta mqabbel mal-istudju P05101 (ara sezzjoni 4.4).
English: Dizziness*, headache*
Maltese: Sturdament*, uġigħ ta' ras*
English: Victrelis is a strong inhibitor of CYP3A4/5.
Maltese: Victrelis huwa inibitur qawwi ta' CYP3A4/5.
English: A limited number of subjects (n=12) received ≤ 200mg/day of ribavirin for at least
Maltese: Numru limitat ta' individwi (n=12) ħadu ≤ 200 mg/jum
English: • quetiapine - used to treat schizophrenia, bipolar disorder and major depressive disorder
Maltese: • quetiapine - użat għall-kura tal-iskizofrenja, ta' disturb bipolari u ta' disturb ta' dipressjoni maġġuri
English: A clinical drug interaction study with digoxin demonstrated that boceprevir is a mild P-gp inhibitor in vivo, increasing digoxin exposure by 19%.
Maltese: Studju kliniku ta' interazzjoni tal-mediċina b'digoxin wera li boceprevir huwa inibitur ħafif ta' P-gp in vivo, li jżid l-esponiment għal digoxin b'19%.
English: The recommended dose of Victrelis is 4 capsules three times a day (a total of 12 capsules a day).
Maltese: Id-doża rrakkomandata ta' Victrelis hija ta' 4 kapsuli tliet darbiet kuljum (total ta' 12-il kapsula kuljum).
English: Victrelis, in combination with peginterferon alfa and ribavirin, is used for chronic hepatitis C virus infection in adults (also called HCV infection).
Maltese: Victrelis, flimkien ma' peginterferon alfa u ribavirin, jintuża għall-infezzjoni kronika bil-virus talepatite Ċ fl-adulti (msejħa wkoll infezzjoni b'HCV).
English: Haemorrhagic diathesis, lymphadenopathy, lymphopenia
Maltese: Tendenza ta' emorraġija, limfadenopatija, limfopenija
English: As compared to the combination of boceprevir with peginterferon alfa-2b and ribavirin, the combination of boceprevir with peginterferon alfa-2a and ribavirin was associated with a higher rate of neutropenia (including grade 4 neutropenia) and a higher rate of infections.
Maltese: Meta mqabbel mal-kombinazzjoni ta' boceprevir ma' peginterferon alfa-2b u ribavirin, ilkombinazzjoni ta' boceprevir ma' peginterferon alfa-2a u ribavirin kienet assoċjata ma' rata ogħla ta' newtropenija (inkluż newtropenija ta' grad 4) u rata ogħla ta' infezzjonijiet.
English: The subjects were then continued on different treatment regimens based on TW 8 response-guide therapy (Victrelis-RGT).
Maltese: L-individwi mbagħad tkomplew fuq skedi differenti ta' kura bbażati fuq terapija ggwidata mir-rispons (Victrelis-RGT) ta' TW 8.
English: Maraviroc 150 mg twice daily when co-administered with boceprevir.
Maltese: Maraviroc 150 mg darbtejn kuljum meta mogħti fl-istess ħin ma' boceprevir.
English: In clinical trials, the proportion of subjects who received erythropoietin for the management of anaemia was 43% (667/1,548) of subjects in the Victrelis-containing arms compared to 24% (131/547) of subjects receiving peginterferon alfa-2b and ribavirin alone.
Maltese: Fi provi kliniċi, il-proporzjon tal-individwi li ħadu erythropoietin għallimmaniġġar tal-anemija kien ta' 43% (667/1,548) tal-individwi fil-fergħat li kien fihom Victrelis meta mqabbel ma' 24% (131/547) tal-individwi li kienu qed jieħdu peginterferon alfa-2b u ribavirin biss.
English: A randomized, parallel-arm, open-label study (P06086) was conducted to compare two strategies for the management of anaemia (use of erythropoietin versus ribavirin dose reduction) in 687 subjects including 60 cirrhotic patients with previously untreated CHC genotype 1 infection who became anaemic during therapy with 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
Maltese: Sar studju każwali, b'fergħa parallela, open-label (P06086) biex iqabbel żewġ strateġiji għall-immaniġġjar tal-anemija (l-użu ta' erythropoietin versus tnaqqis fid-doża ta' ribavirin) f'687 individwu inkluż 60 pazjent ċirrotiku b'infezzjoni ta' CHC tal-ġenotip 1 li ma kinux ikkurati qabel u li saru anemiċi waqt terapija bi 800 mg ta' Victrelis mill-ħalq tliet darbiet kuljum flimkien ma' PR [peginterferon alfa-2b 1.5 µg/kg/ġimgħa taħt il-ġilda u ribavirin skont il-piż (600 1,400 mg
English: Co-administration of Victrelis with alfuzosin and silodosin is contraindicated (see section 4.3).
Maltese: L-għoti fl-istess ħin ta' Victrelis ma' alfuzosin u silodosin huwa kontraindikat (ara sezzjoni 4.3).
English: Bronchitis*, cellulitis*, herpes simplex, influenza, oral fungal infection, sinusitis
Maltese: Bronkite*, ċellulite*, herpes simplex, influwenza, infezzjoni bil-moffa fil-ħalq, sinożite
English: 4.3 Contraindications
Maltese: 6.1 Lista ta' eċċipjenti