FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should be discontinued after 10 days if no clinical improvement is apparent.
Maltese: It-trattament għandu jitwaqqaf wara 10 ijiem jekk ma jidher ebda titjib kliniku.
English: Two cats were more active when given placebo and for the remaining 23 cats no significant difference in activity could be detected between robenacoxib and placebo treatment.
Maltese: Żewġ qtates kienu aktar attivi meta ngħataw placebo u għall-bqija tat-23 qattus ma kienx hemm differenza sinifikanti bejn trattament b'robenacoxib u bi placebo.
English: No changes in the QT interval were observed after single intravenous administration of 2 or 4 mg /kg robenacoxib to anaesthetised healthy cats.
Maltese: L-ebda tibdil fl-intervall QT ma kien osservat wara l amministrazzjoni ta' doża waħda intravenuża ta' 2 jew 4 mg/kg robenacoxib fi qtates f'saħħithom anestetizzati.
English: In healthy young cats aged 7-8 months, oral robenacoxib administered at high overdoses (4, 12 or 20 mg/kg/day for 6 weeks) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Maltese: Fi qtates żgħar b'saħħithom ta' bejn 7-8 xhur, robenacoxib orali mogħti f'dożi għoljin ħafna (4, 12 jew 20 mg/kg/kuljum għal 6 ġimgħat) ma pproduċiex xi sinjali ta' tossiċità, inkluż ebda evidenza ta' xi tossiċità gastrointestinali, tal-kliewi jew tal-fwied u ebda effett fuq il-ħin ta' fsada.
English: The biological relevance of increased QT intervals outside of normal variations observed following overdose of robenacoxib is unknown.
Maltese: Irrilevanza bioloġika fuq iż-żjieda fl-intervall QT barra minn varjazzjonijiet normali osservati wara doża eċċessiva ta' robenacoxib m'hijiex magħrufa.
English: EU/2/08/089/012 (7 tablets) EU/2/08/089/013 (14 tablets) EU/2/08/089/014 (28 tablets) EU/2/08/089/015 (70 tablets) EU/2/08/089/026 (30 x 1 tablets) EU/2/08/089/027 (60 x 1 tablets)
Maltese: EU/2/08/089/014 (28 pilloli) EU/2/08/089/015 (70 pilloli) EU/2/08/089/026 (30 x 1 pillola) EU/2/08/089/027 (60 x 1 pillola)
English: After oral administration of robenacoxib tablets at approximately 2 mg/kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1,159 ng/ml and an AUC of 1,337 ng·h/ml.
Maltese: Wara għoti mill-ħalq ta' pilloli robenacoxib f'doża ta' madwar 2 mg/kg mingħajr ikel, l-għola konċentrazzjonijiet fid-demm jintlaħqu malajr b'Tmax ta' 0.5 h, Cmax ta' 1159 ng/ml u AUC ta' 1337
English: In healthy young dogs aged 5-6 months, oral robenacoxib administered at high overdoses (4, 6 or 10 mg/kg/day for 6 months) did not produce any signs of toxicity, including no evidence of any gastrointestinal, kidney or liver toxicity and no effect on bleeding time.
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) jekk ikun hemm bżonn Fi klieb żgħar b'saħħithom ta' bejn 5 u 6 xhur, robenacoxib orali mogħti f'dożi għoljin ħafna (4, 6 jew 10 mg/kg/kuljum għal 6 xhur) ma pproduċiex xi sinjali ta' tossiċità, inkluż ebda evidenza ta' xi tossiċità gastrointestinali, tal-kliewi jew tal-fwied u ebda effett fuq il-ħin ta' fsada.
English: In cats robenacoxib is extensively metabolised by the liver.
Maltese: Il bijoakkumulazzjoni ta' metaboliti ma ġietx ittestjata.
English: ATCvet code: QM01AH91.
Maltese: Jekk jgħoġbok irreferi għall-sezzjoni 4.5.
English: Repeated subcutaneous administration at dosages of 2-20 mg/kg produced no change in the blood profile, with neither bioaccumulation of robenacoxib nor enzyme induction.
Maltese: Għoti taħt il-ġilda ripetut f'dożaġġi ta' 2-20 mg/kg ma pproduċa ebda bidla fil-profil tad-demm, la b'bijoakkumulazzjoni ta' robenacoxib u lanqas b'induzzjoni ta' enzim.
English: EU/2/08/089/016 (7 tablets) EU/2/08/089/017 (14 tablets) EU/2/08/089/018 (28 tablets) EU/2/08/089/019 (70 tablets) EU/2/08/089/028 (30 x 1 tablets) EU/2/08/089/029 (60 x 1 tablets)
Maltese: EU/2/08/089/018 (28 pilloli) EU/2/08/089/019 (70 pilloli) EU/2/08/089/028 (30 x 1 pillola) EU/2/08/089/029 (60 x 1 pillola)
English: Do not use together with non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, medicines commonly used in the treatment of pain, inflammation and allergies.
Maltese: Tużax ma' mediċini anti-infjammatorji mhux sterojdali (NSAIDs) jew kortikosterojdi, mediċini użati b'mod komuni fit-trattament ta' uġigħ, infjammazzjoni u allerġiji.
English: The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Maltese: Is-sigurtà ta' dan il-prodott mediċinali veterinarju ma ġietx stabbilita fi qtates li ji¿nu inqas minn 2.5 kg jew li għandhom inqas minn 4 xhur.
English: For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in dogs.
Maltese: Agħti bħala kura orali waħdanija qabel kirurġija ortopedika.
English: PACKAGE LEAFLET:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Do not use in cats suffering from gastrointestinal ulceration.
Maltese: Tużax fuq qtates li jkunu qegħdin isofru minn ulċerazzjoni gastrointestinali.
English: 5.1 Pharmacodynamic properties
Maltese: QM01AH91. 5.1 Kwalitajiet farmakodinamiċi
English: Robenacoxib has a relatively small volume of distribution (Vss 190 ml/kg) and is highly bound to plasma proteins (>99%).
Maltese: Robenacoxib għandu volum ta' distribuzzjoni relattivament żgħir (Vss 190 ml/kg) u jabbina ħafna ma'
English: A dose-dependent increase in the QT interval, a decreased heart rate and corresponding increased respiratory rate were observed in laboratory studies.
Maltese: Żieda fl-intervall QT dipendenti mid-doża, tnaqqis fittaħbit tal-qalb u żieda korrispondenti fir-rata respiratorja ġew osservati fi studji fil-laboratorju.
English: Co-administration of robenacoxib tablets with the entire daily food ration produced no delay in Tmax (0.5 h), but a lower Cmax (691 ng/ml)
Maltese: (0.5 h), iżda Cmax (691 ng/ml) kien aktar baxx u AUC kemmxejn iktar baxx (1,069 ng·h/ml).
English: After oral administration of robenacoxib flavoured tablets at 1 mg/kg without food, peak blood concentrations are attained rapidly with a Tmax of 0.5 h, a Cmax of 1,124 ng/ml and an AUC of 1,249 ng·h/ml.
Maltese: Wara għoti mill-ħalq ta' pilloli bit-togħma robenacoxib f'doża ta' 1 mg/kg mingħajr ikel, jintlaħqu konċentrazzjonijiet għoljin fid-demm malajr b'Tmax ta' 0.5 h, Cmax ta' 1,124 ng/ml u AUC ta' 1,249
English: In artificially induced inflammation in dogs, robenacoxib reduced pain and inflammation with single oral doses ranging from 0.5 to 8 mg/kg and a rapid onset of action (0.5 h).
Maltese: F'infjammazzjoni indotta b'mod artifiċjali fil-klieb, robenacoxib naqqas l-uġigħ u l-infjammazzjoni b'dożi orali waħdanija li varjaw minn 0.5 sa 8 mg/kg u bidu rapidu tal-azzjoni (0.5 h).
English: Response to long-term treatment should be monitored at regular intervals by a veterinary surgeon.
Maltese: Ir-rispons għall-trattament fit-tul għandu jkun monitorat f'intervalli regolari mit-tabib veterinarju.
English: • The PRAC reviewed the totality of the available data, including clinical trials, meta-analysis and publications, the MAHs' responses as well as the report from the Scientific Advisory Group in Cardiovascular Issues;
Maltese: • Il-PRAC irreveda d-dejta kollha disponibbli, inkluż il-provi kliniċi, metaanaliżijiet u pubblikazzjonijiet, ir-risponsi tal-MAHs kif ukoll ir-rapport mill-Grupp Xjentifiku Konsultattiv fi
English: • The PRAC considered that the available efficacy data indicates that dual RAS blockade therapy does not provide significant benefit in the general patient population although certain patient subpopulations may benefit from treatment, provided that it occurs only under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure;
Maltese: • Il-PRAC ikkunsidra li d-dejta disponibbli dwar l-effikaċja tindika li t-terapija ta' imblokk RAS doppja ma tipprovdix benefiċċju sinifikanti fil-popolazzjoni ġenerali tal-pazjenti, għalkemm ċerti sottopopolazzjonijiet ta' pazjenti jafu jibbenefikaw mill-kura, sakemm issir biss taħt superviżjoni ta' speċjalista u soġġett għal sorveljanza mill-qrib frekwenti tal-funzjoni renali, l
English: Overall 95% CI
Maltese: Total 95% CI
English: Genotype 1a 88% (44/50)
Maltese: Ġenotip 1a 88% (44/50)
English: Observed: Rosuvastatin ↑
Maltese: Rosuvastatin ↑
English: (20 mg once daily)/
Maltese: (20 mg darba kuljum)/
English: Increased score (Worsening)
Maltese: Punteġġ miżjud (Aggravament)
English: Mean ratio (90% confidence interval)a,b
Maltese: Proporzjon medju (90% intervall ta' kunfidenza)a,b
English: ANTIFUNGALS Ketoconazole
Maltese: ANTIFUNGALI Ketoconazole
English: Genotype 1a 6% (3/50)
Maltese: Ġenotip 1a 6% (3/50)
English: NA = Not available a Mean value from multiple experiments of same laboratory replicon.
Maltese: Valur medju minn esperimenti multipli tal-istess replikon tal-laboratorju.
English: (Inhibition of OATP1B)
Maltese: (Inibizzjoni ta' OATP1B)
English: Film-coating: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red
Maltese: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red
English: Variants were selected at NS5A resistance associated positions 24, 28, 30, 31, 32, 58, 92 and 93.
Maltese: Intgħażlu varjanti fil-pożizzjonijiet assoċjati mar-reżistenza ta' NS5A 24, 28, 30, 31, 32, 58, 92 u 93.
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Tenofovir disoproxil fumarate
Maltese: INIBITURI TA' REVERSE TRANSCRIPTASE Tenofovir disoproxil fumarate
English: NA = Not available
Maltese: NA = Mhux disponibbli
English: 0.005-0.016c
Maltese: 0.005-0.016ċ
English: Observed: Pravastatin ↑
Maltese: Pravastatin ↑
English: 3a 4a 4d
Maltese: 4a 4d
English: Expected:
Maltese: Osservata:
English: • H2-receptor antagonists (such as famotidine, cimetidine, nizatidine or ranitidine).
Maltese: • antagonist tar-riċetturi H2 (bħal famotidine, cimetidine, nizatidine jew ranitidine).
English: SVR with Y93H 95% CI
Maltese: SVR bla Y93H 95% CI
English: Genotype 1b 89% (16/18) Genotype 3
Maltese: Ġenotip 1b 89% (16/18) Ġenotip 3
English: Cirrhotic (n = 80)
Maltese: Ċirrotiċi (n=80)
English: 0.002-0.006c
Maltese: 0.002-0.006ċ
English: Norelgestromin Norgestrel
Maltese: Norelgestrom in
English: 42% (5c/12)
Maltese: 42% (5ċ/12)
English: Albumin Bilirubin INR
Maltese: Albumina Bilirubina INR
English: 92.9% to 98.0% 82.8% to 96.4% 92.8% to 98.6%
Maltese: 92.9% sa 98.0% 82.8% sa 96.4% 92.8% sa 98.6%
English: 63.9% to 95.5% 6.8% to 93.2% 69.6% to 98.8%
Maltese: 63.9% sa 95.5% 6.8% sa 93.2% 69.6% sa 98.8%
English: The tablet is 20 mm long and 10 mm wide.
Maltese: Il-pillola hija twila 20 mm u wiesgħa 10 mm.
English: Genotype 1b 11% (2/18) Genotype 3
Maltese: Ġenotip 1b 11% (2/18) Ġenotip 3
English: Film-coating Polyvinyl alcohol Titanium dioxide Polyethylene glycol Talc
Maltese: Kisja tar-rita Polyvinyl alcohol Titanium dioxide Polyethylene glycol Talc
English: ANTICONVULSANTS Phenytoin
Maltese: MEDIĊINI ANTIKONVULŻIVI Phenytoin
English: Tablet core: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Maltese: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
English: Table 18: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Velpatasvir Compared to Subjects with Normal Renal Function
Maltese: Tabella 18: Effett ta' Gradi Differenti ta' Indeboliment tal-Kliewi fuq Esponimenti (AUC) għal Sofosbuvir, GS-331007, u Velpatasvir Meta Mqabbla ma' Individwi b'Funzjoni Normali talKliewi
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Maltese: Sofosbuvir jiġi metabolizzat b'mod estensiv fil-fwied biex jifforma n-nucleoside analog farmakoloġikament attiv triphosphate GS-461203.
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: Steady-state Cmax for sofosbuvir, GS-331007 and velpatasvir were 566, 868 and 259 ng/mL, respectively.
Maltese: Is-Cmax fl-istat fiss għal sofosbuvir, GS-331007 u velpatasvir kienet 566, 868 u 259 ng/mL, rispettivament.
English: • light-headedness;
Maltese: • palpitazzjonijiet;
English: GS-331007 is not an inhibitor of OAT1, OCT2, and MATE1.
Maltese: GS-331007 mhuwiex inibitur ta' OAT1, OCT2, u MATE1.
English: Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant
Maltese: Ċirrożi ta' Klassi B Child-Pugh-Turcotte (CPT) qabel ittrapjant:
English: Virologic failure (relapse and on-treatment failure) Genotype 1a
Maltese: Falliment viroloġiku (rikaduta u falliment waqt il-kura) Ġenotip 1a
English: Sofosbuvir EC50, nMa Velpatasvir EC50, nMa
Maltese: Ġenotip tar-replikons Sofosbuvir EC50, nMa Velpatasvir EC50, nMa 1a
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Maltese: Sofosbuvir u GS-331007 mhumiex inibituri tat-trasportaturi tal-mediċina P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 u OCT1.
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Maltese: Il-passaġġ ta' attivazzjoni metabolika jinvolvi idrolisi sekwenzjali tal-carboxyl ester moiety ikkatalizzata minn cathepsin umana A (CatA) jew carboxylesterase 1 (CES1) u phosphoramidate cleavage minn histidine triad nucleotide-binding protein 1 (HINT1) segwita minn fosforilazzjoni mill-passaġġ tal-bijosintesi ta' pyrimidine nucleotide.
English: At clinically relevant plasma concentration, velpatasvir is not an inhibitor of hepatic transporters bile salt export pump (BSEP), sodium taurocholate cotransporter protein (NTCP), OATP2B1, OATP1A2 or organic cation transporter (OCT) 1, renal transporters OCT2, OAT1, OAT3, multidrug resistance-associated protein 2 (MRP2) or multidrug and toxin extrusion protein (MATE) 1, or CYP or uridine glucuronosyltransferase (UGT) 1A1 enzymes.
Maltese: F'konċentrazzjoni fil-plażma klinikament rilevanti, velpatasvir mhuwiex inibitur tat-trasportaturi epatiċi tal-pompa li tesporta l-melħ biljari (BSEP, bile salt export pump), il-proteina kotrasportatur tas-sodium taurocholate (NTCP), OATP2B1, OATP1A2 jew ittrasportatur tal-cations organiċi (OCT) 1, it-trasportaturi renali OCT2, OAT1, OAT3, il-proteina 2 assoċjata mar-reżistenza għal ħafna mediċini (MRP2, multidrug resistance-associated protein 2) jew ilproteina ta' estrużjoni ta' ħafna mediċini u tat-tossini (MATE, multidrug and toxin extrusion protein) 1, jew l-enzimi CYP jew uridine glucuronosyltransferase (UGT) 1A1.
English: Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Maltese: Epclusa hu indikat għall-kura ta' infezzjoni tal-virus tal-epatite Ċ kronika (HCV - chronic hepatitis C virus) fl-adulti (ara sezzjonijiet 4.2, 4.4 u 5.1).
English: Site-directed mutagenesis of the S282T substitution in replicons of genotype 1 to 6 conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the replication viral capacity by 89% to 99% compared to the corresponding wild-type.
Maltese: Mutaġenesi diretta mis-sit tas-sostituzzjoni S282T f'replikons ta' ġenotipi 1 sa 6, irriżultat f'suxxettibilità mnaqqsa ta' minn 2 sa 18-il darba għal sofosbuvir u naqqset il-kapaċità tar-replikazzjoni virali b'89% sa 99% meta mqabbla mal-wild-type korrispondenti.
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: • rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
Maltese: • rifampicin u rifabutin (antibijotiċi li jintużaw għall-kura ta' infezzjonijiet, li jinkludu t-tuberkulożi);
English: TN = treatment-naïve patients; TE = treatment-experienced patients (including those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor)
Maltese: TN = treatment naive patients (pazjenti li ma rċivewx kura fil-passat); TE = treatment-experienced patients (pazjenti li rċivew kura) (inklużi dawk li ma rnexxewx b'kors ibbażat fuq peginterferon alfa + ribavirin b'inibitur tal-HCV protease jew mingħajru)
English: Severe RI (eGFR <30 mL/min/1.7 3m2)
Maltese: RI Sever (eGFR <30 mL/ min/ 1.73m2)
English: 94.3% to 98.9% 85.3% to 97.8% 95.9% to 99.9%
Maltese: 3% sa 97.8% 95.9% sa 99.9%
English: Another patient had virus with Y93H at baseline and virologic failure and also developed low levels (< 5%) of NS5B NI RAVs N142T and E237G at failure.
Maltese: Pazjent ieħor kellu virus b'Y93H fil-linja bażi u falliment viroloġiku u żviluppa wkoll livelli baxxi (< 5%) ta' NS5B NI RAVs N142T u E237G fil-falliment.
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of velpatasvir by 13-fold against genotype 1a HCV replicons.
Maltese: Il-preżenza ta' 40% serum uman ma kellha l-ebda effett fuq l-attività kontra HCV ta' sofosbuvir, iżda naqqset l-attività kontra HCV ta' velpatasvir bi 13-il darba kontra replikons tal-ġenotip 1a tal-HCV.
English: Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 for sofosbuvir (n = 982), GS-331007 (n = 1,428) and velpatasvir (n = 1,425) were 1,260, 13,970 and 2,970 ng•h/mL, respectively.
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni f'pazjenti infettati bl-HCV, l-AUC0-24 il-medja fl-istat fiss għal sofosbuvir (n = 982), GS-331007 (n = 1,428), u velpatasvir (n = 1,425) kienet 1,260, 13,970 u 2,970 ng•h/mL, rispettivament.
English: Non-Cirrhotic (n = 197)
Maltese: Mhux Ċirrotiċi (n=197)
English: (Induction of P-gp and CYPs)
Maltese: (Induzzjoni ta' P-gp u CYPs)
English: Genotype 1, 2, 3, 4, 5 and 6
Maltese: Ġenotipi 1, 2, 3, 4, 5 jew 6
English: Site-directed mutagenesis of known NS5A 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 mis-sit ta' NS5A RAVs uriet 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: Genotypes 2, 4, 5 or 6 Total
Maltese: Ġenotipi 2, 4, 5 jew 6 Total
English: After a single 400 mg oral dose of [14C]-sofosbuvir, GS-331007 accounted for approximately > 90% of total systemic exposure.
Maltese: Wara doża orali waħda ta' 400 mg ta' [14C]-sofosbuvir, GS-331007 jammonta għal madwar > 90% tal-esponiment sistemiku totali.
English: Total (all GTs) (n = 106)
Maltese: Total (il-GTs kollha) (n = 106)
English: Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
Maltese: Sofosbuvir u GS-331007 mhumiex sottistari jew inibituri ta' enzimi ta' UGT1A1 jew CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, u CYP2D6.
English: • efavirenz used to treat HIV infection;
Maltese: • efavirenz użat biex jikkura infezzjoni tal-HIV;
English: The pharmacokinetics of sofosbuvir, GS-331007 and velpatasvir in paediatric patients have not been established (see section 4.2).
Maltese: Il-farmakokinetika ta' sofosbuvir, GS-331007 u velpatasvir f'pazjenti pedjatriċi ma ġietx stabbilita (ara sezzjoni 4.2).
English: Total (all GTs) (n = 624)
Maltese: Total (il-GTs kollha) (n = 624)
English: 1.4-fold↑
Maltese: 1.6 darbiet↑ 2.1 darbiet↑
English: No NS5B nucleoside inhibitor (NI) RAVs were observed at failure in the 2 patients.
Maltese: L-ebda NS5B nucleoside inhibitor (NI) RAVs ma kienu osservati fil-falliment fiż-2 pazjenti.
English: Clinical studies in patients with Renal Impairment - study 4062
Maltese: Studji kliniċi f'pazjenti b'Indeboliment tal-Kliewi - studju 4062
English: 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
Maltese: 1,000 mg kuljum għal pazjenti li jiżnu < 75 kg u 1,200 mg għal dawk li jiżnu ≥ 75 kg
English: Skin disorders Frequency not known: Stevens-Johnson syndrome
Maltese: Is-sindrome ta' Stevens-Johnson
English: (n = 331), velpatasvir AUC0-24 and Cmax were 37% lower and 41% lower, respectively in HCV-infected patients.
Maltese: Meta mqabbla ma' pazjenti b'saħħithom (n = 331), l-AUC0-24 u s-Cmax ta' velpatasvir kienu 37% aktar baxxi u 41% aktar baxxi, rispettivament, f'pazjenti infettati bl-HCV.
English: Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and “7916” on the other side.
Maltese: Pillola miksija b'rita, roża, b'forma ta' djamant, b'daqs ta' 20 mm x 10 mm, imnaqqxa b'“GSI” fuq naħa waħda u “7916” fuq in-naħa l-oħra.
English: Protein binding of GS-331007 was minimal in human plasma.
Maltese: It-twaħħil ta' GS-331007 mal-proteina kien minimu fil-plażma umana.
English: The overall mean CD4+ count was 598 cells/µL (range: 183−1513 cells/µL).
Maltese: Il-medja globali tal-ammont ta' CD4+ kienet ta' 598 ċellula/μL (medda: 183−1,513-il ċellula/μL).
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Maltese: Il-maġġoranza tad-doża ta' sofosbuvir irkuprata fl-awrina kienet GS-331007 (78%) filwaqt li 3.5% ġiet irkuprata bħala sofosbuvir.
English: The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma.
Maltese: Il-monohydroxylated u desmethylated velpatasvir kienu l-metaboliti identifikati fil-plażma tal-bniedem.
English: The pharmacokinetics of sofosbuvir was studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir, relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Maltese: Il-farmakokinetika ta' sofosbuvir ġiet studjata f'pazjenti li kienu negattivi għal HCV, b'indeboliment tal-kliewi ħafif (eGFR ≥ 50 u < 80 mL/min/1.73 m2), moderat (eGFR ≥ 30 u < 50 mL/min/1.73m2), u sever (eGFR < 30 mL/min/1.73 m2) u pazjenti b'ESRD li kienu jeħtieġu l-emodijaliżi wara doża waħda ta' 400 mg ta' sofosbuvir, meta mqabbla ma' pazjenti b'funzjoni normali tal-kliewi (eGFR > 80 mL/min/1.73 m2).
English: With any baseline NS5A RAVs Without baseline NS5A RAVs
Maltese: Bi kwalunkwe NS5A RAVs fil-linja bażi
English: Among the patients who received treatment with Epclusa + RBV for 12 weeks, 29% (25/85) of patients had baseline virus with NS5A RAVs: 29% (19/66), 75% (3/4), 15% (2/13), and 50% (1/2) for patients with genotype 1, 2, 3 and 4 HCV, respectively.
Maltese: Fost ilpazjenti li ngħataw kura b'Epclusa + RBV għal 12-il ġimgħa, 29% (25/85) tal-pazjenti kellhom virus fil-linja bażi b'NS5A RAVs: 29% (19/66), 75% (3/4), 15% (2/13), u 50% (1/2) għal pazjenti b'HCV ta' ġenotip 1, 2, 3 u 4, rispettivament.
English: The proportions of patients with genotype 1, 2, 3, 4, 6 or indeterminate HCV infection were 42%, 12%, 27%, 7% , 3%, and 9%, respectively.
Maltese: Il-proporzjonijiet ta' pazjenti b'infezzjoni tal-HCV ta' ġenotip 1, 2, 3, 4, 6 jew mhux determinat kienu ta' 42%, 12%, 27%, 7%, 3%, u 9%, rispettivament.