FrancophonIA/ELRC3.0 huggingface dataset:
English: Daclatasvir is an inhibitor of nonstructural protein 5A (NS5A), a multifunctional protein that is an essential component of the HCV replication complex.
Slovenian: Daklatasvir je zaviralec nestrukturne beljakovine 5A (NS5A), multifunkcijske beljakovine, ki je bistveni sestavni del replikacijskega kompleksa HCV. Daklatasvir zavira tako replikacijo virusne RNA
English: In patients who received daclatasvir 60 mg tablet orally followed by 100 μg [
Slovenian: Pri bolnikih, ki so peroralno prejeli 60-mg tableto daklatasvirja, ki ji je sledil intravenski 100-μg odmerek [
English: Expected due to inhibition of P-gp by
Slovenian: Pričakovano zaradi zaviranja P-gp z
English: SVR12 rates were consistently high across most subgroups including gender, age, race, baseline HCV RNA, and IL28B genotype.
Slovenian: Delež SVR12 je bil konsistentno visok v večini podskupin, vključno glede na spol, starost, raso, izhodiščno vrednost HCV RNA in genotip IL28B.
English: Population pharmacokinetic analysis of data from clinical studies identified race (categories “other” [patients who are not white, black or Asian] and “black”) as a statistically significant covariate on daclatasvir apparent oral clearance (CL/F) and apparent volume of distribution (Vc/F) resulting in slightly higher exposures compared to white patients, but the magnitude of the effect on daclatasvir
Slovenian: Analiza podatkov populacijske farmakokinetike iz kliničnih študij kaže, da je rasa (kategoriji “drugi” [bolniki, ki niso belci, črnci ali Azijci] in “črni”) statistično pomembna kovariata za navidezni peroralni očistek daklatasvirja (CL/F) in navidezni volumen porazdelitve (Vc/F), pri čemer so bile izpostavljenosti nekoliko višje v primerjavi z bolniki bele rase, obseg učinka na izpostavljenost daklatasvirju pa ni bil klinično pomemben.
English: 4.2 Posology and method of administration Treatment with Daklinza should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Slovenian: Zdravljenje z zdravilom Daklinza mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa C.
English: It is used to treat adults with hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.
Slovenian: Daklatasvir uporabljamo za zdravljenje odraslih s hepatitisom C. Hepatitis C je nalezljiva bolezen, ki prizadene jetra in je posledica okužbe z
English: Treatment outcomes in study AI444010 for patients with HCV genotype 4 are presented in Table 14.
Slovenian: Izidi zdravljenja v študiji AI444010 pri bolnikih z genotipom 4 HCV so prikazani v tabeli 14.
English: Among 258 patients who achieved SVR12 with daclatasvir and sofosbuvir (± ribavirin) with a median duration of post-SVR12 follow-up of 38 months, no relapses occurred (with relapses defined as confirmed or last available HCV RNA ≥ LLOQ).
Slovenian: Pri 258 bolnikih, ki so pri zdravljenju z daklatasvirjem in sofosbuvirjem (± ribavirin) dosegli SVR12, 38 mesecev (mediana vrednost trajanja spremljanja) po-SVR12 ni prišlo do ponovitve (ponovitev je bila opredeljena kot potrjena ali zadnja znana vrednost HCV RNA ≥ LLOQ).
English: Daclatasvir in combination with peginterferon alfa and ribavirin AI444042 and AI444010 were randomised, double-blind studies that evaluated the efficacy and safety of daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV) in the treatment of chronic HCV infection in treatment-naïve adults with compensated liver disease (including cirrhosis).
Slovenian: Daklatasvir v kombinaciji s peginterferonom alfa in ribavirinom Študiji AI444042 in AI444010 sta bili randomizirani, dvojno slepi študiji, ki sta vrednotili učinkovitost in varnost daklatasvirja v kombinaciji s peginterferonom alfa in ribavirinom (pegIFN/RBV) pri zdravljenju kronične okužbe s HCV pri predhodno še nezdravljenih odraslih s kompenzirano boleznijo jeter (vključno s cirozo).
English: Frequency of baseline NS5A resistance-associated variants (RAVs) Baseline NS5A RAVs were frequently observed in clinical studies of daclatasvir.
Slovenian: Pogostnost RAV NS5A (RAV - resistance-associated variants) v izhodišču V kliničnih študijah daklatasvirja so v izhodišču pogosto opazili RAV NS5A.
English: Category/ Substitution, n (%) Genotype 1a Genotype 1b Genotype 2 Genotype 3 N=79
Slovenian: Genotip 1a Genotip 1b Genotip 2 Genotip 3 N=79
English: Daklinza 30 mg and 60 mg film-coated tablets are available in packs of 28 tablets in non-perforated calendar blisters and perforated unit dose blisters.
Slovenian: Daklinza 30 mg in 60 mg filmsko obložene tablete so na voljo v pakiranjih po 28 tablet v neperforiranih koledarskih pretisnih omotih in perforiranih enoodmernih pretisnih omotih.
English: SVR12 was achieved by 74% of patients in this study (genotype 1a: 70%, genotype 1b: 79%).
Slovenian: V tej študiji je bil SVR12 dosežen pri 74 % bolnikov (genotip 1a:
English: SVR was the primary endpoint to determine the HCV cure rate, which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12) for studies AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), ALLY-3C (AI444379), AI444042 and AI444043 and as HCV RNA undetectable at 24 weeks after the end of treatment (SVR24) for study
Slovenian: Trajen virološki odziv (SVR - sustained virologic response) je bil primarni opazovani dogodek za določitev deleža ozdravitve HCV in je bil v študijah AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), ALLY-3C (AI444379), AI444042 in AI444043 opredeljen kot vrednost HCV RNA, manjša od LLOQ v 12. tednu po koncu zdravljenja (SVR12), v študiji AI444010 pa kot nezaznavna raven HCV RNA v 24. tednu po koncu zdravljenja (SVR24).
English: Table 15: Summary of noted newly emergent HCV NS5A substitutions on treatment or during follow-up in treated non-SVR12 subjects infected with HCV genotypes 1
Slovenian: Tabela 15: Povzetek opaženih novih pojavov substitucij NS5A HCV med zdravljenjem ali spremljanjem pri zdravljenih bolnikih brez SVR12, okuženih z genotipi 1 do
English: decreased appetite insomnia, irritability insomnia headache dizziness, migraine dizziness, migraine
Slovenian: zmanjšanje apetita nespečnost, razdražljivost nespečnost glavobol omotica, migrena omotica, migrena vročinski oblivi
English: Maternal toxicity including mortality, abortions, adverse clinical signs, decreases in body weight and food consumption was noted in both species at exposures 25-fold (rat) and 72-fold (rabbit) the clinical AUC exposure.
Slovenian: Toksičnost za matere je vključevala pogine, splave, neželene klinične znake, zmanjšanje telesne mase in manjše uživanje hrane, kar so opazili pri obeh vrstah pri izpostavljenosti, ki so bile na osnovi vrednosti AUC 25-krat (podgane) in 72-krat (kunčice) večje od izpostavljenosti
English: Table 8: Demographics and main disease characteristics in Study ALLY-1 Cirrhotic cohort N = 60
Slovenian: Tabela 8: Demografske lastnosti bolnikov in glavne značilnosti bolezni v študiji ALLY-1 Kohorta s cirozo
English: At the 60 mg dose, exposure to daclatasvir was similar between healthy subjects and HCV-infected patients.
Slovenian: Pri uporabi 60 mg odmerka je bila izpostavljenost daklatasvirju pri zdravih osebah in bolnikih, okuženih s HCV,
English: 60 mg tablet orally followed by 100 μg [13C,15N]-daclatasvir intravenous dose, estimated volume of distribution at steady state was 47 l. In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes.
Slovenian: 100-μg odmerek [13C,15N]-daklatasvirja, je ocenjeni volumen porazdelitve v stanju dinamičnega ravnovesja znašal 47 l. In vitro študije kažejo, da daklatasvir aktivno in pasivno prehaja v hepatocite.
English: Table 10: Demographics and baseline characteristics in Study ALLY-2 daclatasvir + sofosbuvir 12 weeks N = 153
Slovenian: Tabela 10: Demografske in izhodiščne lastnosti v študiji ALLY-2 daklatasvir + sofosbuvir 12 tednov N = 153
English: However, as this is a limited effect, dose adjustment of concomitantly administered CYP3A4 substrates is not necessary.
Slovenian: Zaradi tega omejenega učinka pri sočasni uporabi substratov za CYP3A4 njihovega odmerka ni treba prilagajati.
English: When Daklinza is used together with sofosbuvir (without ribavirin), the following side effects have
Slovenian: Pri uporabi zdravila Daklinza skupaj s sofosbuvirjem (brez ribavirina) so poročali o naslednjih
English: The daclatasvir EC50 values in the replicon system were 0.003-1.25 nM for genotypes 3a, 4a, 5a and 6a, and 0.034-19 nM for genotype 2a as well as 0.020 nM for infectious genotype 2a (JFH-1) virus.
Slovenian: Vrednosti EC50 daklatasvirja v sistemih replikona za genotipe 3a, 4a, 5a in 6a znašajo 0,003-1,25 nM, za genotip 2a 0,034-19 nM, za kužni genotip 2a
English: Glucose levels of diabetic patients initiating DAA therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Slovenian: Pri sladkornih bolnikih, ki so se začeli zdraviti z neposredno delujočim protivirusnim zdravilom, je treba zlasti v prvih treh mesecih skrbno spremljati ravni krvnega sladkorja ter po potrebi prilagoditi zdravilo za zdravljenje sladkorne bolezni.
English: HCV Treatmentexperienced* N=52
Slovenian: HCV, predhodno zdravljenje* N=52
English: nausea (feeling sick), diarrhoea, abdominal pain joint pain, aching or tender muscles, not caused by exercise When Daklinza is used together with sofosbuvir and ribavirin, the following side effects have been
Slovenian: navzea (siljenje na bruhanje), driska, bolečina v trebuhu bolečina v sklepih, bolečina ali občutljivost v mišicah, ki nista posledica telesne aktivnosti Pri uporabi zdravila Daklinza skupaj s sofosbuvirjem in z ribavirinom so poročali o naslednjih neželenih učinkih:
English: For dosing recommendations with HIV antiviral agents, refer to section 4.5.
Slovenian: Za priporočila za odmerjanje skupaj s protivirusnimi zdravili proti HIV glejte poglavje 4.5.
English: Daklinza must always be used together with other medicines against hepatitis C infection and must
Slovenian: Zdravilo Daklinza je treba vedno uporabljati skupaj z drugimi zdravili proti okužbi z virusom hepatitisa C in se ga nikoli ne sme uporabljati samega.
English: The active transport is mediated by OCT1 and other unidentified uptake transporters, but not by organic anion transporter (OAT) 2, sodium-taurocholate cotransporting
Slovenian: Aktivni transport poteka s pomočjo OCT1 in z drugimi neznanimi prenašalci privzema, ne pa tudi s prenašalcem organskih anionov (OAT - organic anion transporter) 2, polipeptidnim soprenašalcem za natrijev tavroholat (NTCP - sodium-taurocholate cotransporting polypeptide) ali polipeptidnimi prenašalci organskih anionov (OATP - organic anion transporting polypeptide).
English: For patients with Child-Pugh A, B, or C cirrhosis or recurrence of HCV infection after liver transplantation, the recommended initial dose of ribavirin is 600 mg daily with food.
Slovenian: Priporočeni začetni odmerek ribavirina pri bolnikih s cirozo Child-Pugh A, B ali C ali ponovitvijo okužbe s HCV po presaditvi jeter je 600 mg na dan skupaj s hrano.
English: The overall median HCV RNA was 6.38 log10 IU/mL; the majority of patients (59%) had IL-28B rs12979860 non-CC genotypes.
Slovenian: Mediana skupna vrednost HCV RNA je bila 6,38 log10 i.e./ml, večina bolnikov (59 %) pa je imela ne-CC genotipe IL-28B rs12979860.
English: This is due to liver function that may change during treatment with Daklinza.
Slovenian: Razlog za to so možne spremembe delovanja jeter pri zdravljenju z zdravilom Daklinza.
English: The Cmax and AUC of total daclatasvir (free and protein-bound drug) were lower in subjects with hepatic impairment; however, hepatic impairment did not have a clinically significant effect on the free drug concentrations of daclatasvir
Slovenian: Vrednosti Cmax in AUC skupnega daklatasvirja (prosto in na beljakovine vezano zdravilo) so bile pri bolnikih z okvaro jeter manjše, vendar pa okvara jeter ni imela klinično pomembnega učinka na proste koncentracije daklatasvirja (glejte poglavje 4.2).
English: SVR12 rates were higher for patients with the IL-28B CC genotype than for those with non-CC genotypes and for patients with baseline HCV RNA less than 800,000 IU/ml but consistently higher in the daclatasvir-treated patients than for placebo-treated
Slovenian: Pri bolnikih s CC genotipi IL-28B so bili deleži SVR12 višji kot pri bolnikih z ne-CC genotipi in bolnikih z izhodiščno vrednostjo HCV RNA manjšo od 800.000 i.e./ml, vendar v vseh podskupinah dosledno višji pri bolnikih, ki so se zdravili z daklatasvirjem, kot pri bolnikih, ki so prejemali placebo.
English: Caution should be used when Daklinza is coadministered with rosuvastatin or other substrates of OATP 1B1 or BCRP.
Slovenian: Pri sočasni uporabi zdravila Daklinza in rosuvastatina ali drugih substratov za OATP 1B1 ali BCRP je potrebna previdnost.
English: Treatmentexperienced N=24
Slovenian: Predhodno že zdravljeni N=24
English: Among 302 patients who achieved SVR12 with daclatasvir + pegIFN/RBV with a median duration of post-SVR12 follow-up of 44 months, 2% (n=6) of patients relapsed.
Slovenian: Pri 302 bolnikih, ki so pri zdravljenju z daklatasvirjem + pegIFN/RBV dosegli SVR12, je v 44 mesecih (mediana vrednost trajanja spremljanja) po-SVR12 do ponovitve prišlo pri 2 % (n=6)
English: ** The patient with virologic breakthrough met the original protocol definition of confirmed HCV RNA <LLOQ, detectable at treatment Week 8.
Slovenian: ** Bolnik s povečanjem virusnega bremena med zdravljenjem (“virologic breakthrough”) je v 8. tednu zdravljenja dosegel s protokolom opredeljeno potrjeno vrednost HCV RNA < LLOQ.
English: Contraindications of concomitant use (see section 4.3) Daklinza is contraindicated in combination with medicinal products that strongly induce CYP3A4 and P-gp, e.g. phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum), and thus may lead to lower exposure and loss of efficacy of Daklinza.
Slovenian: Kontraindikacije za sočasno uporabo (glejte poglavje 4.3) Uporaba zdravila Daklinza je kontraindicirana v kombinaciji z zdravili, ki močno inducirajo CYP3A4 in P-gp, npr. fenitoin, karbamazepin, okskarbazepin, fenobarbital, rifampicin, rifabutin, rifapentin, sistemski deksametazon in zdravila rastlinskega izvora, ki vsebujejo šentjanževko (Hypericum perforatum), saj se pri sočasni uporabi lahko zmanjša izpostavljenost zdravilu Daklinza in izgubi
English: Resistance in clinical studies
Slovenian: Odpornost v celični kulturi
English: Advanced cirrhosis and post-liver transplant (ALLY-1) In study ALLY-1, the regimen of daclatasvir, sofosbuvir, and ribavirin administered for 12 weeks was evaluated in 113 adults with chronic hepatitis C and Child-Pugh A, B or C cirrhosis (n=60) or HCV recurrence after liver transplantation (n=53).
Slovenian: Napredovala ciroza in stanje po presaditvi jeter (ALLY-1) V študiji ALLY-1 so režim uporabe daklatasvirja, sofosbuvirja in ribavirina 12 tednov proučevali pri 113 odraslih s kroničnim hepatitisom C in cirozo Child-Pugh A, B ali C (n=60) ali ponovitvijo HCV
English: Subjects with end-stage renal disease requiring haemodialysis had a 27% increase in daclatasvir AUC and a 20% increase in unbound AUC compared to subjects with normal renal function (see section 4.2).
Slovenian: Pri osebah s končno odpovedjo ledvic, ki potrebujejo zdravljenje s hemodializo, je bila vrednost AUC daklatasvirja večja za 27 %, vrednost AUC nevezanega daklatasvirja pa večja za 20 % kot pri osebah z normalnim delovanjem ledvic (glejte
English: Following multiple oral doses of daclatasvir 60 mg once daily in combination with peginterferon alfa and ribavirin in treatment-naïve patients with genotype 1 chronic HCV, the geometric mean (CV%) daclatasvir Cmax was 1534 (58) ng/ml, AUC0-24h was 14122 (70) ng•h/ml, and
Slovenian: Pri ponavljajočih se peroralnih odmerkih daklatasvirja v odmerku 60 mg enkrat na dan v kombinaciji s peginterferonom alfa in ribavirinom pri predhodno nezdravljenih bolnikih s kronično okužbo z genotipom 1 HCV so bile geometrijske srednje (KV %) vrednosti daklatasvirja naslednje: vrednost Cmax 1.534 (58) ng/ml, vrednost AUC0-24h 14.122 (70) ng•h/ml, vrednosti Cmin pa 232 (83) ng/ml.
English: Observed emergent NS5A resistance-associated variants are reported in Table 15.
Slovenian: Opažen pojav RAV NS5A je prikazan v tabeli 15.
English: Four patients discontinued the Daklinza regimen for adverse events, only one of which was considered
Slovenian: Štirje bolniki so bili zaradi neželenih učinkov izključeni iz režima zdravljenja z zdravilom Daklinza, vendar pa so jih le pri enem bolniku opredelili kot povezane z zdravljenjem v
English: The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients <75 kg or ≥75 kg, respectively).
Slovenian: Pri kombiniranem zdravljenju z zdravilom Daklinza je odmerek ribavirina odvisen od telesne mase (1.000 mg pri bolnikih s telesno maso < 75 kg in 1.200 mg pri bolnikih s telesno maso ≥ 75 kg).
English: Treatmentexperienced* N=51
Slovenian: Predhodno že zdravljeni* N=51
English: Some other medicines can interact with Daklinza, affecting the levels of Daklinza in your body.
Slovenian: Nekatera druga zdravila lahko vplivajo na delovanje zdravila Daklinza in spremenijo količino zdravila Daklinza v telesu.
English: Coadministration with medicinal products that strongly induce cytochrome P450 3A4 (CYP3A4) and P-glycoprotein transporter (P-gp) and thus may lead to lower exposure and loss of efficacy of Daklinza.
Slovenian: Pri sočasni uporabi zdravil, ki so močni induktorji citokroma P450 3A4 (CYP3A4) in prenašalca P-glikoproteina (P-gp), se izpostavljenost zdravilu Daklinza lahko zmanjša in izgubi njegova učinkovitost.
English: Tell your doctor immediately if you are taking any medicines for heart problems and during treatment
Slovenian: Takoj obvestite zdravnika, če jemljete katero koli zdravilo za zdravljenje težav s srcem in med palpitacije (neprijetne občutke ob hitrem ali močnem utripanju srca),
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines
Slovenian: Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Daklinza, nizke ravni sladkorja v krvi (hipoglikemija).
English: Daklinza in combination with peginterferon alfa and ribavirin The most frequently reported adverse reactions were fatigue, headache, pruritus, anaemia, influenzalike illness, nausea, insomnia, neutropenia, asthenia, rash, decreased appetite, dry skin, alopecia, pyrexia, myalgia, irritability, cough, diarrhoea, dyspnoea and arthralgia.
Slovenian: Zdravilo Daklinza v kombinaciji s peginterferonom alfa in z ribavirinom Najpogosteje poročani neželeni učinki so bili utrujenost, glavobol, srbenje, anemija, gripi podobna bolezen, navzea, nespečnost, nevtropenija, astenija, izpuščaj, zmanjšanje apetita, suha koža, alopecija, zvišana telesna temperatura, bolečina v mišicah, razdražljivost, kašelj, driska, dispneja in bolečina v sklepih.
English: Ribavirin Dosing Guidelines
Slovenian: Smernice za odmerjanje ribavirina
English: * Mainly interferon-based therapy, but 7 patients received sofosbuvir + ribavirin and 2 patients received a ** Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for 11 patients or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2 for 7 patients.
Slovenian: 7 bolnikov je prejemalo sofosbuvir + ribavirin, 2 bolnika pa ** Ciroza je bila pri 14 bolnikih določena z biopsijo jeter (METAVIR F4), pri 11 bolnikih z metodo FibroScan (> 14,6 kPa), pri 7 bolnikih pa z oceno FibroTesta ≥ 0,75 in indeksom razmerja med aspartataminotransferazo (AST) in trombociti (APRI) > 2.
English: 24 weeks
Slovenian: 12-tedensko zdravljenje
English: End of treatment HCV RNA undetectable
Slovenian: HCV RNA nezaznavna
English: Data to support the treatment of genotype 2 infection with Daklinza and sofosbuvir are limited.
Slovenian: Podatki, ki podpirajo zdravljenje okužbe z genotipom 2 z zdravilom Daklinza in sofosbuvirjem, so
English: Most patients (71%, including 98% of prior PI failures) had IL-28B rs12979860 non-CC
Slovenian: Večina bolnikov (71 %, vključno z 98 % bolnikov z neuspešnim predhodnim zdravljenjem z zaviralcem proteaze) je imela ne-CC genotipe IL-28B rs12979860.
English: Ten percent of patients had compensated cirrhosis, and 75% of patients had IL-28B rs12979860 non-CC genotypes.
Slovenian: Deset odstotkov bolnikov je imelo kompenzirano cirozo, 75 % bolnikov pa je imelo ne-CC genotipe IL-28B rs12979860.
English: Among treatment-naïve patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance between SVR12 and SVR24 was 99.5% independent of
Slovenian: Pri predhodno nezdravljenih bolnikih z ovrednoteno vrednostjo HCV-RNA pri obeh kontrolnih obiskih, to je v 12. in 24. tednu, je bila ugotovljena 99,5-% skladnost med SVR12 in SVR24, neodvisno od trajanja zdravljenja.
English: - Tablet core: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, silicon dioxide (E551) and magnesium stearate - Film-coating: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake (E132), yellow iron oxide (E172)
Slovenian: - Filmska obloga: hipromeloza, titanov dioksid (E171), makrogol 400, indigotin (E132) in
English: How long to take Daklinza Make sure you take Daklinza for as long as your doctor has told you to take it.
Slovenian: Zdravilo Daklinza morate jemati tako dolgo, kot vam je to predpisal zdravnik.
English: Coadministration with strong inducers of CYP3A4 and P-gp is contraindicated while dose adjustment of Daklinza is recommended when coadministered with moderate inducers of CYP3A4 and P-gp (see Table 4).
Slovenian: Sočasna uporaba z močnimi induktorji CYP3A4 in P-gp je kontraindicirana, pri sočasni uporabi zmernih induktorjev CYP3A4 in P-gp pa je odmerek zdravila Daklinza priporočljivo prilagoditi (glejte tabelo 4).
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV DAA treatment.
Slovenian: Pri sladkornih bolnikih se lahko po začetku zdravljenja okužbe s HCV z neposredno delujočim protivirusnim zdravilom izboljša nadzor nad sladkorjem, kar ima lahko za posledico simptomatsko hipoglikemijo.
English: Table 4: Interactions and dose recommendations with other medicinal products
Slovenian: Tabela 4: Interakcije in priporočila za odmerjanje pri sočasni uporabi drugih zdravil Priporočila pri sočasni uporabi
English: * Mainly interferon-based therapy +/-NS3/4 PI. ** Cirrhosis was determined by liver biopsy, FibroScan >14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2.
Slovenian: ** Ciroza je bila določena z biopsijo jeter, z metodo FibroScan (> 14,6 kPa) ali z oceno FibroTesta ≥ 0,75 in indeksom razmerja med aspartat-aminotransferazo (AST) in trombociti (APRI) > 2.
English: Seven percent of patients had compensated cirrhosis; 92% had HCV genotype 1 (72% 1a and 20% 1b) and 8% had HCV genotype 4; 65% of patients had IL-28B rs12979860 non-CC genotypes.
Slovenian: Sedem odstotkov bolnikov je imelo kompenzirano cirozo jeter, 92 % bolnikov je imelo genotip 1 HCV (72 % 1a in 20 % 1b) ter 8 % bolnikov genotip 4 HCV. 65 % bolnikov je imelo
English: Daklinza contains less than 1 mmol sodium (23 mg) per maximum dose of 90 mg, that is to say
Slovenian: Bolniki na dieti z nadzorovanim vnosom natrija Zdravilo Daklinza vsebuje manj kot 1 mmol (23 mg) natrija na največji odmerek 90 mg, kar v bistvu
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Daklinza.
Slovenian: Po začetku jemanja zdravila Daklinza morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.