FrancophonIA/ELRC3.0 huggingface dataset:
English: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite Diabetes mellitus, hypertriglyceridemia*
Maltese: Ipergliċemija, iperurikemija, ipokalċemija, diżidrazzjoni,
English: The use of ribavirin in combination treatment with interferon alfa-2b was evaluated in a number of clinical trials.
Maltese: L-użu ta' ribavirin fit-trattament ta' kombinazzjoni ma' interferon alfa-2b kien evalwat f'għadd ta' studji kliniċi.
English: Do not use Ribavirin BioPartners after the expiry date which is stated on the carton.
Maltese: Tużax Ribavirin BioPartners wara d-data ta' skadenza li tidher fuq il-kartuna ta' barra.
English: Hepatic decompensation in HCV/HIV co-infected patients with advanced cirrhosis: Co-infected patients with advanced cirrhosis receiving highly active anti-retroviral therapy (HAART) may be at increased risk of hepatic decompensation and death.
Maltese: Pazjenti infettati fl-istess ħin li jkollhom ċirrożi avvanzata li jkunu qed jirċievu terapija anti-retrovirali attiva ħafna (HAART) jista' jkollhom riskju akbar ta' dikompens epatiku u mewt.
English: - urination disorders, urinary tract infection, - difficult, irregular, or no menstrual period, abnormally heavy and prolonged menstrual periods, disorder of vagina, inflammation of the vagina, testis pain, development of male body traits, - acne, bruising, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), increased or decreased sensitivity to touch, increased sweating, increase in muscle movement, tense muscle, irritation or itching at the site of injection, limb pain, nail disorder, numbness or tingling feeling, pale skin, rash with raised spotted lesions, shaky hands, redness of skin or skin disorder, skin discolouration, skin sensitive to sunlight, skin wound, swelling due to a build-up of excess water, swollen glands (swollen lymph nodes), tremor, tumour
Maltese: - disturbi fl-awrina, infezzjoni fil-passaġġ ta' l-awrina, - pirjid mestrwali diffiċli, irregolari, jew ma jiġix, perjids mestrwali qawwija ħafna u jdumu, disturbi tal-vaġina, infjammazzjoni tal-vaġina, infjammazzjoni tal-vaġina, uġigħ fit-testikli, żvilupp ta' karatteristiċi tal-ġisem maskili, - akne, tbenġil, ekżema (ġilda iffjammata, ħamra, tħokkok u xotta li tista' tkun b'feriti li jnixxu), żieda jew tnaqqis fis-sensittività biex tħoss, żieda fl-għaraq, żieda fil-movimenti tal-muskoli, muskoli ibsin, irritazzjoni jew ħakk fis-sit mnejn tingħata l-injezzjoni, uġigħ fid-dirgħajn jew riġlejn, disturbi tad-dwiefer, sensazzjoni ta' tnemnim jew tingiż, ġilda pallida, raxx b'feriti mgħollijin u bi dbabar, idejn jirtogħdu, ħmura tal-ġilda jew disturbi tal-ġilda, ġilda titlef ilkulur, ġilda sensittiva għad-dawl, ferita fil-ġilda, nefħa minħabba li jakkumula l-ilma żejjed, glandoli minfuħin (nodi tal-limf minfuħin), tregħid, tumor (mhux speċifikat).
English: - various laboratory blood values abnormalities.
Maltese: - diversi anormalitajiet fir-riżultati tat-testijiet tad-demm fil-laboratorju.
English: Some data suggest that HIV/HCV co-infected patients receiving abacavir-containing ART may be at risk of a lower response rate to pegylated interferon/ribavirin therapy.
Maltese: Xi dejta tindika li pazjenti ko-infettati b'HIV/HCV li jkunu qed jieħdu ART li jkun fiha abacavir jista' jkollhom riskju li jkollhom rata ta' rispons aktar baxxa għat-terapija b'interferon pegilat/ribavirin.
English: Most cases of anaemia, neutropenia, and thrombocytopenia were mild (WHO grades 1 or 2).
Maltese: Il-maġġoranza tal-każijiet ta' anemija, newtropenija u tromboċitopenija kienu ħfief (gradi 1 jew 2 tal-WHO).
English: Use in renal impairment: The pharmacokinetics of ribavirin are altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Maltese: Il-farmakokinetika ta' ribavirin tinbidel f'pazjenti li għandhom il-kliewi ma jaħdimx sew minħabba li jidher tnaqqis fit-tneħħija tal-krejatinina f'dawn il-pazjenti (ara sezzjoni 5.2).
English: CD4 lymphocytes decrease:
Maltese: Pazjenti li ma kienux ikkurati qabel:
English: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µl.
Maltese: Hemm tagħrif limitat disponibbli dwar l-effikaċja u s-sigurtà (N = 25) f'pazjenti li huma infettati fl-istess ħin b'HCV/HIV, b'għadd ta' CD4 ta' anqas minn 200 ċellula/µl.
English: If serum creatinine rises to > 2.0 mg/dl (Table 3), Ribavirin BioPartners and interferon alfa-2b must be discontinued.
Maltese: Jekk ilkreatinina fis-serum togħla għal > 2.0 mg/dl (Tabella 3), Ribavirin BioPartners u
English: In HCV/HIV co-infected patients receiving HAART, the following other side effects have occurred with the combination of ribavirin and peginterferon alfa-2b (not listed above in adults side effects):
Maltese: F'pazjenti ko-infettati b'HCV/HIV li qed jirċievu HAART, l-effeti sekondarji oħra li ġejjin seħħew mal-għoti flimkien ta' ribavirin u peginterferon alfa-2b (mhux elenkati hawn fuq fl-effetti sekondarji
English: The dose of Ribavirin BioPartners is based on patient body weight (Table 1).
Maltese: Id-doża ta' Ribavirin BioPartners hija bbażata fuq kemm jiżen tal-pazjent (Tabella 1).
English: Naïve patients
Maltese: FARMAKOLOĠIKU
English: The use of pegylated alpha interferons and ribavirin concomitantly with azathioprine should be avoided.
Maltese: L-użu ta' peginterferon alfa pegilati u ribavirin flimkien ma' azathioprine għandu jiġi evitat.
English: What Ribavirin BioPartners looks like and contents of the pack Ribavirin BioPartners is a round, white film coated-tablet, rounded on the upper and lower side.
Maltese: Id-doża ta' Ribavirin BioPartners hi bażata fuq il-piż tal-ġisem tal-pazjent.
English: Dose to be administered
Maltese: Sewqan u tħaddim ta' magni
English: In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 15 mg/kg/day and 3 million international units (MIU)/m2 three times a week respectively (Table 2).
Maltese: Doża li għandha tingħata għat-terapija kombinata b'interferon alfa-2b: Fi studji kliniċi li saru f'din il-popolazzjoni ribavirin u interferon alfa-2b intużaw f'dożi ta' 15 mg/kg/jum u 3 miljun unità internazzjonali (MIU)/m2 tliet darbiet fil-ġimgħa rispettivament (Tabella 2).
English: Contact your doctor immediately if any of the following side effects occur during treatment with Ribavirin BioPartners in combination with an alpha interferon product: - chest pain or persistent cough; changes in the way your heart beats, fainting, - confusion, feeling depressed; suicidal thoughts or aggressive behaviour, attempt suicide,
Maltese: L-effetti sekondarji oħra li ġejjin kienu rrappurtati wkoll bit-taħlita ta' ribavarin u prodott alfa interferon: - ħsibijiet mhux normali, smigħ jew tara oġġetti li ma jkunux hemm, stat mentali mibdul,
English: EU/1/11/676/001Jevtana 60 mg Concentrate and solvent for solution for infusion
Maltese: EU/1/11/676/001 Jevtana
English: Concentrate: 1.5ml Solvent: 4.5 ml
Maltese: ml olvent: 4.5 ml t + 1
English: Intravenous use Concentrate: vial (glass) Solvent: vial (glass)
Maltese: żu għal ġol-vini entrat: kunjett Solvent: kunjett (ħġieġ)
English: Packaging
Maltese: unjett
English: 92% (109/118)c
Maltese: 92% (109/118)ċ
English: Vosevi contains lactose monohydrate.
Maltese: Vosevi fih lactose monohydrate.
English: Cimetidined Nizatidined Ranitidined
Maltese: Cimetidined Nizatidined
English: AUC Cmin
Maltese: Cmax AUC Cmin
English: ANTIARRHYTHMICS Amiodarone
Maltese: ANTIARRITMIĊI Amiodarone
English: e. Bioequivalence/Equivalence boundary 80-125%.
Maltese: Limitu tal-bijoekwivalenza / ekwivalenza 80-125%.
English: The overall SVR12 rate was 100% (31/31).
Maltese: Ir-rata globali ta' SVR12 kienet ta' 100% (31/31).
English: Severe RI (eGFR
Maltese: RI Sever (eGFR
English: (Induction of CYPs)
Maltese: (Induzzjoni ta' CYPs)
English: Relapsed 2%
Maltese: Rikadutad 2% Oħrajne
English: Iron oxide black (E172), iron oxide red (E172), iron oxide yellow (E172), macrogol, polyvinyl alcohol, talc, titanium dioxide (E171)
Maltese: Iron oxide iswed (E172), iron oxide aħmar (E172), iron oxide isfar (E172), macrogol, polyvinyl alcohol, talc, titanium dioxide (E171)
English: Table 3: Adverse drug reactions identified with Vosevi Frequency
Maltese: Tabella 3: Reazzjonijiet avversi tal-mediċina identifikati b'Vosevi Frekwenza
English: f. Data obtained from transiently transfected replicons.
Maltese: f. Data miksuba minn replicons transfettati temporanjament.
English: HMG-CoA REDUCTASE INHIBITORS Atorvastatin
Maltese: INIBITURI TA' HMG-CoA REDUCTASE Atorvastatin
English: • H2-receptor antagonists (such as famotidine, cimetidine, nizatidine or ranitidine).
Maltese: • antagonisti tar-riċetturi H2 (bħal famotidine, cimetidine, nizatidine jew ranitidine).
English: Observed: Raltegravir
Maltese: Raltegravir
English: Overall SVR12a Genotype 1b
Maltese: SVR12 globalia Ġenotip 1b
English: Iron oxide black (E172) Iron oxide red (E172) Iron oxide yellow (E172)
Maltese: Iron oxide iswed (E172) Iron oxide aħmar (E172) Iron oxide isfar (E172) Macrogol
English: GT = genotype * The most common prior NS5A inhibitors were ledipasvir (LDV) (51%), daclatasvir (27%), and ombitasvir (11%).
Maltese: GT = ġenotip * L-inibituri ta' NS5A l-aktar komuni ta' qabel kienu ledipasvir (LDV) (51%), daclatasvir (27%), u ombitasvir (11%). a.
English: Severe bradycardia and heart block
Maltese: Bradikardija severa u mblokkar tal-qalb (heart block)
English: 73m2)
Maltese: min/ 1.73m2)
English: • ethinylestradiol containing medicines, including many contraceptives.
Maltese: • mediċini li fihom ethinylestradiol, inklużi ħafna kontraċettivi.
English: Voriconazole (Inhibition of CYP3A)
Maltese: Voriconazole (Inibizzjoni ta' CYP3A)
English: Voxilaprevir metabolites also identified in faeces included des[methylcyclopropylsulphonamide]-voxilaprevir (22.1%), which is formed intestinally, dehydrovoxilaprevir (7.5%), and two des-[methylcyclopropylsulphonamide]-oxy-voxilaprevir metabolites (5.4% and 3.9%).
Maltese: Il-metaboliti ta' voxilaprevir identifikati wkoll fl-ippurgar inkludew des-[methylcyclopropylsulphonamide]-voxilaprevir (22.1%), li huwa fformat intestinalment, dehydro-voxilaprevir (7.5%), u żewġ metaboliti des-[methylcyclopropylsulphonamide]-oxyvoxilaprevir (5.4% u 3.9%).
English: Vosevi contains lactose.
Maltese: Vosevi fih lactose.
English: • ciclosporin, used to suppress the immune system.
Maltese: • ciclosporin, użat għas-soppressjoni tas-sistema immunitarja.
English: Voxilaprevir ↑
Maltese: Voxilaprevir darbiet↑
English: (Increase in gastric pH decreases velpatasvir solubility)
Maltese: (Żieda fil-pH gastriku tnaqqas issolubilità ta' velpatasvir)
English: DAA: direct-acting antiviral; GT: genotype; SOF: sofosbuvir; VEL: velpatasvir; VOX: voxilaprevir
Maltese: GT: ġenotip; SOF: sofosbuvir; VEL: velpatasvir; VOX: voxilaprevir
English: Each film-coated tablet contains 117 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 117 mg ta' lactose (bħala lactose monohydrate).
English: Effect on fluvastatin, lovastatin, pitavastatin and simvastatin not studied.
Maltese: L-effett fuq fluvastatin, lovastatin, pitavastatin u simvastatin ma ġiex studjat.
English: In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a, and 4a.
Maltese: F'assay bijokimiku, GS-461203 inibixxa l-attività ta' polymerase ta' NS5B rikombinati mill-ġenotipi 1b, 2a, 3a u 4a tal-HCV.
English: Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Maltese: Vosevi huwa indikat għall-kura ta' infezzjoni kronika bil-virus tal-epatite Ċ (HCV - chronic hepatitis C virus) fl-adulti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Dabigatran etexilate (P-gp substrate) and rosuvastatin (OATP1B and BCRP substrate) are contraindicated (see section 4.3 and Table 2).
Maltese: Dabigatran etexilate (sottostrat ta' P-gp) u rosuvastatin (sottostrat ta' OATP1B u BCRP) huma kontraindikati (ara sezzjoni 4.3 u Tabella 2).
English: NS3 and NS5A
Maltese: NS3 u/jew NS5A.
English: Rifampicin (multiple dose) (Induction of P-gp and CYPs)
Maltese: Rifampicin (doża multipla) (Induzzjoni ta' P-gp u CYPs)
English: Replicons containing NS3 protease from clinical isolates
Maltese: Replicons li fihom protease NS3 minn iżolati kliniċi
English: • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures);
Maltese: • carbamazepine, phenobarbital u phenytoin (mediċini li jintużaw għall-kura ta' epilessija u għall-prevenzjoni ta' aċċessjonijiet);
English: When Vosevi or its components taken together were administered with food, sofosbuvir AUC0-inf and Cmax were 64% to 144% and 9% to 76% higher, respectively; velpatasvir AUC0-inf and Cmax were 40% to 166% and 37% to 187% higher, respectively; and voxilaprevir AUC0-inf and Cmax were 112% to 435% and 147% to 680% higher, respectively.
Maltese: Meta Vosevi jew il-komponenti tiegħu meħuda flimkien ingħataw mal-ikel, l-AUC0-inf u s-Cmax ta' sofosbuvir kienu 64% sa 144% u 9% sa 76% ogħla, rispettivament; l-AUC0-inf u s-Cmax ta' velpatasvir kienu 40% sa 166% u 37% sa 187% ogħla, rispettivament; u l-AUC0-inf u s-Cmax ta' voxilaprevir kienu 112% sa 435% u 147% sa 680% ogħla, rispettivament.
English: Mean ratio (90% confidence interval)a,b Recommendation concerning co-administration with Vosevi
Maltese: Proporzjon medju (90% intervall ta' kunfidenza)a,b
English: Very common headache Gastrointestinal disorders:
Maltese: Disturbi gastro-intestinali:
English: Most subjects had genotype 1 (61% (19/31) [1a, 48% (15/31); 1b, 13% (4/31)]) or genotype 3 (26% (8/31)) HCV infection.
Maltese: Il-biċċa l-kbira tal-individwi kellhom infezzjoni ta' HCV ta' ġenotip 1 (61% (19/31) [1a, 48% (15/31); 1b, 13% (4/31)]) jew ġenotip 3 (26% (8/31)).
English: Of the 31 patients enrolled, 74% (23/31) were male, 81% (25/31) were white, 71% (22/31) had a baseline body mass index < 30 kg/m2, 48% (15/31) had compensated cirrhosis, 58% (18/31) had previously received sofosbuvir, velpatasvir and voxilaprevir, and 42% (13/31) had previously received sofosbuvir and velpatasvir.
Maltese: Mill-31 pazjent irreġistrati, 74% (23/31) kienu rġiel, 81% (25/31) kienu bojod, 71% (22/31) kellhom indiċi tal-massa tal-ġisem fil-linja bażi ta' < 30 kg/m2, 48% (15/31) kellhom ċirrożi kkumpensata, 58% (18/31) kienu rċivew sofosbuvir, velpatasvir u voxilaprevir qabel, u 42% (13/31) kienu rċivew sofosbuvir u velpatasvir qabel.
English: Sofosbuvir and GS-331007 are not inhibitors or inducers of CYP or uridine glucuronosyltransferase (UGT) 1A1 enzymes.
Maltese: Sofosbuvir u GS-331007 mhumiex inibituri jew indutturi tal-enzimi CYP jew ta' uridine glucuronosyltransferase (UGT) 1A1.
English: GS-461203 is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Maltese: GS-461203 la hu inibitur tad-DNA u RNA polymerases tal-bniedem, u lanqas mhu inibitur ta' RNA polymerase mitokondrijali.
English: Adverse drug reaction Nervous system disorders:
Maltese: Disturbi fis-sistema nervuża:
English: DAA: direct-acting antiviral agent * In clinical trials the DAA experienced patients had been exposed to combination regimens containing any of the following: daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, sofosbuvir, velpatasvir, voxilaprevir (administered with sofosbuvir and velpatasvir for less than 12 weeks)
Maltese: DAA: direct-acting antiviral agent (aġent antivirali li jaġixxi direttament) * Fi provi kliniċi l-pazjenti li rċivew DAA fil-passat kienu esposti għal korsijiet ta' kombinazzjoni li kien fihom kwalunkwe wieħed minn dawn li ġejjin: daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, sofosbuvir, velpatasvir, voxilaprevir (mogħti ma' sofosbuvir u velpatasvir għal inqas minn 12-il ġimgħa)
English: The most common adverse reactions in patients receiving voxilaprevir 900 mg were diarrhoea (34%), nausea (17%) and headache
Maltese: L-aktar reazzjonijiet avversi komuni f'pazjenti li ngħataw voxilaprevir 900 mg kienu dijarea (34%), dardir (17%) u wġigħ ta' ras (9%).
English: Voxilaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease.
Maltese: Voxilaprevir huwa inibitur pan-ġenotipiku tal-protease NS3/4A tal-HCV.
English: • tenofovir disoproxil fumarate, or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
Maltese: • tenofovir disoproxil fumarate, jew kwalunkwe mediċina li fiha tenofovir disoproxil fumarate,
English: Carbamazepine (Induction of P-gp and CYPs)
Maltese: Carbamazepine (Induzzjoni ta' P-gp u CYPs)
English: Posology
Maltese: Post
English: • atazanavir, efavirenz or lopinavir, used to treat HIV infection;
Maltese: • atazanavir, efavirenz jew lopinavir, użati biex jikkuraw infezzjoni bl-HIV;
English: For voxilaprevir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were Q41H, A156V/T/L and D168E/H/Y.
Maltese: Għal voxilaprevir fir-replicons tal-ġenotip 1-6, sostituzzjonijiet assoċjati mar-reżistenza magħżulin f'2 ġenotipi jew iktar kienu Q41H, A156V/T/L u D168E/H/Y.
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); or uncommon (≥ 1/1000 to < 1/100).
Maltese: Il-frekwenzi huma ddefiniti kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); jew mhux komuni (≥ 1/1000 sa < 1/100).
English: For sofosbuvir, the NS5B substitution S282T was selected in genotype 1-6 replicons and was associated with 2- to 18-fold reduced susceptibility to sofosbuvir.
Maltese: Għal sofosbuvir, intgħażlet is-sostituzzjoni S282T f'NS5B fir-replicons tal-ġenotip 1-6 u kienet assoċjata ma' suxxettibilità mnaqqsa b'minn 2 sa 18-il darba għal sofosbuvir.
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Maltese: Il-maġġoranza taddoża ta' sofosbuvir irkuprata mill-awrina kienet GS-331007 (78%) filwaqt li 3.5% ġiet irkuprata bħala sofosbuvir.
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, multidrug resistanceassociated protein 2 (MRP2), bile salt export pump (BSEP), OATP1B1, OATP1B3 and organic cation transporter (OCT) 1 and GS-331007 is not an inhibitor of OAT1, OAT3, OCT2, and multidrug and toxin extrusion protein (MATE) 1.
Maltese: Sofosbuvir u GS-331007 mhumiex inibituri tat-trasportaturi tal-mediċini P-gp, BCRP, tal-proteina 2 assoċjata mar-reżistenza għal ħafna mediċini (MRP2 - multidrug resistance-associated protein 2), tal-pompa li tesporta l-melħ biljari (BSEP - bile salt export pump), ta' OATP1B1 u OATP1B3 u tat-trasportatur tal-katjoni organiċi (OCT - organic cation transporter) 1 u GS-331007 mhuwiex inibitur ta' OAT1, OAT3, OCT2, u tal-proteina ta' estrużjoni ta' ħafna mediċini u tat-tossini (MATE -multidrug and toxin extrusion protein) 1.
English: S-methadone ↔ ↔ ↔ Sofosbuvir
Maltese: R-methadone ↔ ↔ ↔ S-methadone ↔ ↔ ↔ Sofosbuvir
English: Edoxaban (Inhibition of OATP1B1)
Maltese: Edoxaban (Inibizzjoni ta' OATP1B1)
English: Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm, debossed with “GSI” on one side and “3” on the other side.
Maltese: Pillola miksija b'rita, beige, b'forma ta' kapsula, b'daqs ta' 10 mm x 20 mm, imnaqqxa b'“GSI” fuq naħa waħda u “3” fuq in-naħa l-oħra.
English: Sofosbuvir, velpatasvir and voxilaprevir are substrates of drug transporters P-gp and BCRP while GS-331007 is not.
Maltese: Sofosbuvir, velpatasvir u voxilaprevir huma sottostrati tat-trasportaturi tal-mediċini P-gp u BCRP, filwaqt li GS-331007 mhuwiex.
English: Sofosbuvir, velpatasvir and voxilaprevir are substrates of drug transporters P-gp and BCRP.
Maltese: Sofosbuvir, velpatasvir u voxilaprevir huma sottostrati tat-trasportaturi tal-mediċina P-gp u BCRP.
English: Velpatasvir and voxilaprevir are substrates of drug transporters OATP1B1 and OATP1B3.
Maltese: Velpatasvir u voxilaprevir huma sottostrati tat-trasportaturi tal-mediċina OATP1B1 u OATP1B3.
English: Site directed mutagenesis of known NS3 RAVs showed that substitutions conferring a > 100-fold reduction in voxilaprevir susceptibility are A156V, A156T or A156L in genotype 1a, 1b, 2a, 3a and 4.
Maltese: Mutaġenesi diretta lejn is-sit ta' RAVs f'NS3 magħrufa wriet li sostituzzjonijiet li jagħtu tnaqqis ta' > 100 darba fis-suxxettibilità għal voxilaprevir huma A156V, A156T jew A156L f'ġenotip 1a, 1b, 2a, 3a u 4.
English: Site directed mutagenesis of NS5A resistance associated variants (RAVs) showed that substitutions conferring a > 100-fold reduction in velpatasvir susceptibility are M28G, A92K and Y93H/N/R/W in genotype 1a, A92K in genotype 1b, C92T and Y93H/N in genotype 2b, Y93H in genotype 3, and L31V and P32A/L/Q/R in genotype 6.
Maltese: Mutaġenesi diretta lejn is-sit ta' varjanti assoċjati mar-reżistenza (RAVs - resistance associated variants) għal NS5A wriet li sostituzzjonijiet li jagħtu tnaqqis ta' > 100 darba fis-suxxettibilità għal velpatasvir huma M28G, A92K u Y93H/N/R/W f'ġenotip 1a, A92K f'ġenotip 1b, C92T u Y93H/N f'ġenotip 2b, Y93H f'ġenotip 3, u L31V u P32A/L/Q/R f'ġenotip 6.
English: ACID REDUCING AGENTS Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Maltese: Aluminium jew magnesium hydroxide; calcium carbonate
English: NA: Not available a. Mean value from multiple experiments of same laboratory replicon.
Maltese: Valur medju minn esperimenti multipli tal-istess replicon tal-laboratorju.
English: Observed: Efavirenz Sofosbuvir
Maltese: Efavirenz Sofosbuvir
English: Vosevi 400 mg/100 mg/100 mg film-coated tablets sofosbuvir/velpatasvir/voxilaprevir
Maltese: Vosevi 400 mg/100 mg/100 mg pilloli miksija b'rita sofosbuvir/velpatasvir/voxilaprevir
English: Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Maltese: Sofosbuvir hu promediċina (prodrug) nucleotide li jgħaddi minn metaboliżmu intraċellulari biex jifforma l-uridine analogue triphosphate (GS-461203) farmakoloġikament attiv (GS-461203), li jista' jiġi inkorporat ġol-RNA ta' HCV millNS5B polymerase u jaġixxi bħala terminatur tal-katina.
English: SVR12 was achieved in 18 of 19 (95%) patients who had baseline NS5B NI RAVs in POLARIS-1, including 2 patients who had virus with the S282T NS5B NI RAV in addition to NS5A RAVs at baseline.
Maltese: SVR12 inkiseb fi 18 minn 19-il (95%) pazjent li kellhom RAVs għal NI f'NS5B fil-linja bażi f'POLARIS-1, inklużi 2 pazjenti li kellhom virus bl-RAV S282T għal NI f'NS5B flimkien ma' RAVs f'NS5A fil-linja bażi.
English: Table 2: Interactions between Vosevi and other medicinal products
Maltese: Tabella 2: Interazzjonijiet bejn Vosevi u prodotti mediċinali oħrajn
English: Genotype 5
Maltese: Ġenotip 5
English: In the 13 patients aged 75 to 84 years with available pharmacokinetic data, mean exposure to voxilaprevir was 93% higher than the mean exposure observed in patients aged 18 to 64 years.
Maltese: Fit-13-il pazjent f'età minn 75 sa 84 sena b'data farmakokinetika disponibbli, l-esponiment medju għal voxilaprevir kien 93 % ogħla mill-esponiment medju osservat f'pazjenti f'età minn 18-il sena sa 64 sena.
English: The highest documented doses of sofosbuvir, velpatasvir and voxilaprevir were single doses of 1,200 mg, 500 mg, and 900 mg, respectively.
Maltese: L-ogħla dożi dokumentati ta' sofosbuvir, velpatasvir u voxilaprevir kienu dożi waħdanin ta' 1,200 mg, 500 mg, u 900 mg, rispettivament.
English: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication.
Maltese: Sofosbuvir huwa inibitur pan-ġenotipiku tal-RNA-dependent RNA polymerase NS5B ta' HCV , li hu meħtieġ għar-replikazzjoni virali.