FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients achieving virologic response [HCV RNA undetectable at weeks 4 and 12] completed therapy after 24 weeks while those who did not achieve virologic response received an additional 24 weeks of treatment with pegIFN/RBV, to complete a total of 48 weeks of study therapy.
Slovenian: Bolniki z virološkim odzivom [nezaznavna raven HCV RNA v 4. in 12. tednu] so zdravljenje končali po 24 tednih, bolniki brez virološkega odziva pa so se še dodatnih 24 tednov zdravili s pegIFN/RBV tako, da je zdravljenje v študiji v celoti trajalo 48 tednov.
English: Atazanavir/cobicistat
Slovenian: Atazanavir/kobicistat
English: If you can become pregnant, use effective contraception during and for 5 weeks after your treatment with Daklinza.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem in še 5 tednov po zdravljenju z zdravilom Daklinza uporabljati učinkovito kontracepcijo.
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 exposure is not clinically important.
Slovenian: [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: *PK parameters for daclatasvir when administered with peginterferon alfa and ribavirin in this study were similar to those observed in a study of HCVinfected subjects administered daclatasvir monotherapy for 14 days.
Slovenian: *V tej študiji so bili farmakokinetični parametri za daklatasvir pri uporabi s peginterferonom alfa in ribavirinom podobni parametrom, opaženim v študiji pri bolnikih, okuženih s HCV, ki so prejemali daklatasvir v monoterapiji 14 dni.
English: Expected due to CYP3A4 and P-gp inhibition by verapamil:
Slovenian: Pričakovano zaradi zaviranja CYP3A4 in P-gp z verapamilom:
English: Polyvinyl Chloride/poly-chloro-tri-fluoro-ethylene (PVC/PCTFE) clear blister/aluminum foil lidding.
Slovenian: Prozoren pretisni omot iz polivinilklorida/poliklorotrifluoroetilena (PVC/PCTFE), prekrit z aluminijasto folijo.
English: A third treatment group in study ALLY-2 included 50 HCV treatment-naïve HIV co-infected patients who received daclatasvir and sofosbuvir for 8 weeks.
Slovenian: V tretjo skupino zdravljenja v študiji ALLY-2 je bilo vključenih 50 bolnikov, sočasno okuženih z virusom HIV, ki se predhodno še niso zdravili proti HCV. Ti bolniki so prejemali daklatasvir in sofosbuvir 8 tednov.
English: These medicines lower the effect of Daklinza and may result in your treatment not working.
Slovenian: Ta zdravila zmanjšajo učinek zdravila Daklinza, zato zdravljenje z njim morda ne bo uspešno.
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: 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,
English: Daklinza has not yet been studied in children and adolescents.
Slovenian: Pri otrocih in mladostnikih uporabe zdravila Daklinza še niso raziskali.
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 treatment duration.
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: Very common (may affect more than 1 in 10 people): headache, fatigue
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Patient disposition daclatasvir + sofosbuvir 12 weeks N = 153
Slovenian: Lastnosti bolnikov daklatasvir + sofosbuvir 12 tednov N = 153
English: mean median
Slovenian: povprečje mediana
English: Observed emergent NS5A resistance-associated variants are reported in Table 14.
Slovenian: Opažen pojav RAV NS5A je prikazan v tabeli 14.
English: ↔ Daclatasvir AUC: ↔∗ Cmax: ↔∗ Cmin: ↔∗
Slovenian: ↔ Daklatasvir AUC: ↔∗ Cmax: ↔∗ Cmin: ↔∗
English: One patient with HCV genotype 2 infection was missing both posttreatment Week 12 and 24 data.
Slovenian: Pri enem bolniku, okuženem z genotipom 2 HCV, so manjkali podatki tako v 12. kot 24. tednu po zdravljenju.
English: Daklinza + sofosbuvir + ribavirin for 12 weeks Daklinza + sofosbuvir +/- ribavirin for 24 weeks
Slovenian: Daklinza + sofosbuvir + ribavirin 12 tednov Daklinza + sofosbuvir +/- ribavirin 24 tednov
English: No dose adjustment of Daklinza, peginterferon alfa, or ribavirin is required.
Slovenian: Odmerka zdravila Daklinza, peginterferona alfa ali ribavirina ni treba prilagajati.
English: The highest AUC value in unaffected females was 18-fold the clinical AUC exposure.
Slovenian: Pri neprizadetih samicah je največja vrednost AUC bila 18-krat večja od vrednosti AUC pri klinični uporabi.
English: No dose adjustment of Daklinza 60 mg once daily or lopinavir/ritonavir is required.
Slovenian: Odmerka zdravila Daklinza (60 mg enkrat na dan) ali lopinavirja/ritonavirja ni treba prilagajati.
English: When Daklinza is used in combination with ribavirin, the contraindications and warnings for that medicinal product are applicable.
Slovenian: Če se zdravilo Daklinza uporablja v kombinaciji z ribavirinom, je treba upoštevati kontraindikacije in opozorila za ribavirin.
English: Most patients (61%) had IL-28B rs12979860 non-CC genotypes.
Slovenian: Večina bolnikov (61 %) je imela ne-CC genotipe IL-28B rs12979860.
English: It is not known whether daclatasvir is excreted in human milk.
Slovenian: Ni znano, ali se daklatasvir izloča v materino mleko.
English: ↔ Daclatasvir ↔ Azithromycin or Ciprofloxacin
Slovenian: Pričakovano: ↔ Daklatasvir ↔ Azitromicin ali ciprofloksacin
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
English: Patients in the daclatasvir treatment group who did not have HCV RNA undetectable at both Weeks 4 and 12 and all placebo-treated patients continued pegIFN/RBV for another 24 weeks.
Slovenian: Bolniki v skupini, zdravljeni z daklatasvirjem, ki niso imeli nezaznavne ravni HCV RNA v obeh tednih, to je v 4. in 12. tednu, in vsi bolniki, ki so prejemali placebo, so nadaljevali zdravljenje s pegIFN/RBV nadaljnjih 24 tednov.
English: If you become pregnant, stop taking Daklinza and tell your doctor immediately.
Slovenian: Če med zdravljenjem z zdravilom Daklinza zanosite, takoj prenehajte jemati zdravilo in o tem nemudoma obvestite zdravnika.
English: There is no known antidote for overdose of daclatasvir.
Slovenian: Antidot za preveliko odmerjanje daklatasvirja ni znan.
English: Daklinza + sofosbuvir for 12 weeks
Slovenian: Daklinza + sofosbuvir 12 tednov
English: Among patients who achieved SVR12 with daclatasvir + pegIFN/RBV with a median duration of post-SVR12 follow-up of 22 months, 1% of patients relapsed.
Slovenian: Pri bolnikih, ki so pri zdravljenju z daklatasvirjem + pegIFN/RBV dosegli SVR12, je v 22 mesecih (mediana vrednost trajanja spremljanja) po-SVR12 do ponovitve prišlo pri 1 % bolnikov.
English: Among patients who achieved SVR12 with daclatasvir and sofosbuvir (± ribavirin) with a median duration of post-SVR12 follow-up of 15 months, no relapses have occurred.
Slovenian: Pri bolnikih, ki so pri zdravljenju z daklatasvirjem in sofosbuvirjem (± ribavirin) dosegli SVR12, 15 mesecev (mediana vrednost trajanja spremljanja) po-SVR12 ni prišlo do ponovitve.
English: In study ALLY-3, the combination of daclatasvir and sofosbuvir administered for 12 weeks was evaluated in 152 adults infected with HCV genotype 3; 101 patients were treatment-naïve and 51 patients had failed prior antiviral therapy.
Slovenian: V študiji ALLY-3 so 12-tedensko uporabo kombinacije daklatasvirja in sofosbuvirja vrednotili pri 152 odraslih, okuženih z genotipom 3 HCV. 101 bolnik predhodno še ni bil zdravljen, pri 51 bolnikih pa predhodno protivirusno zdravljenje ni bilo uspešno.
English: Caution should be used when Daklinza is coadministered with rosuvastatin or other substrates of OATP 1B1 or BCRP.
Slovenian: Daklinza in rosuvastatina ali drugih substratov za OATP 1B1 ali BCRP je potrebna previdnost.
English: *Comparison for daclatasvir was to a historical reference (data from 3 studies of daclatasvir 60 mg once daily with peginterferon alfa and ribavirin).
Slovenian: (podatki iz 3 študij daklatasvirja v odmerku 60 mg enkrat na dan s peginterferonom alfa in ribavirinom).
English: Treatment duration was 12 weeks for 82 treatment-naïve HCV genotype 1 patients, and 24 weeks for all other patients in the study.
Slovenian: Pri 82 bolnikih, okuženih z genotipom 1 HCV, ki se predhodno še niso zdravili, je zdravljenje trajalo 12 tednov, pri vseh ostalih bolnikih v študiji pa 24 tednov.
English: For daclatasvirtreated patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance of SVR12 and SVR24 was 97% for HCV genotype 1 and 100% for HCV genotype 4.
Slovenian: Pri z daklatasvirjem zdravljenih bolnikih z ovrednoteno vrednostjo HCV RNA pri obeh kontrolnih obiskih, to je v 12. in 24. tednu, je bila pri genotipu 1 HCV ugotovljena 97-% skladnost med SVR12 in SVR24, pri genotipu 4 HCV pa 100-% skladnost.
English: ↔ Daclatasvir ↔ NRTI
Slovenian: Pričakovano: ↔ Daklatasvir ↔ NRTI
English: Daclatasvir unbound AUC was estimated to be 18%, 39% and 51% higher for subjects with creatinine clearance (CLcr) values of 60, 30 and 15 ml/min, respectively, relative to subjects with normal renal function.
Slovenian: Ocenjena vrednost AUC nevezanega daklatasvirja je bila pri osebah z vrednostjo kreatininskega očistka (CLcr) 60 ml/min večja za 18 %, pri osebah z vrednostjo CLcr 30 ml/min večja za 39 %, pri osebah z vrednostjo CLcr 15 ml/min pa za 51 % večja kot pri osebah z normalnim delovanjem ledvic.
English: Daclatasvir had no effects on fertility in female rats at any dose tested.
Slovenian: Daklatasvir pri nobenem preizkušenem odmerku ni vplival na plodnost samic podgan.
English: MELD score
Slovenian: Ocena MELD
English: Patients with cirrhosis CP A or B
Slovenian: Bolniki s cirozo CP A ali B
English: Potential for interaction with other medicinal products Daclatasvir is a substrate of CYP3A4, P-gp and organic cation transporter (OCT) 1.
Slovenian: Daklatasvir je substrat za CYP3A4, P-gp in prenašalca organskih kationov (OCT - organic cation transporter) 1.
English: End of treatment HCV RNA undetectable
Slovenian: Konec zdravljenja HCV RNA nezaznavna
English: PK trough levels for peginterferon alfa in patients who received peginterferon alfa, ribavirin, and daclatasvir were similar to those in patients who received peginterferon alfa, ribavirin, and placebo.
Slovenian: Pri bolnikih, ki so prejemali peginterferon alfa, ribavirin in daklatasvir, so bile najmanjše farmakokinetične vrednosti peginterferona alfa podobne vrednostim pri bolnikih, ki so prejemali peginterferon alfa, ribavirin in placebo.
English: In patients who received daclatasvir 60 mg tablet orally followed by 100 µg [13C,15N]-daclatasvir intravenous dose, the total clearance was
Slovenian: Pri bolnikih, ki so peroralno prejeli 60-mg tableto daklatasvirja, ki ji je sledil intravenski 100-µg odmerek [13C,15N]-daklatasvirja,
English: The pharmacokinetics of daclatasvir following a single 60 mg oral dose were studied in non-HCV infected subjects with renal impairment.
Slovenian: Farmakokinetiko daklatasvirja po enkratnem peroralnem 60-mg odmerku so proučevali pri osebah z okvaro ledvic brez okužbe s HCV.
English: SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies.
Slovenian: Po režimih kombiniranega protiretrovirusnega zdravljenja (cART - combination antiretroviral therapy), vključno z zdravljenji na osnovi okrepljenega PI, NNRTI in zaviralca integraze (INSTI), so bili deleži SVR > 94 %.
English: Most patients (71%, including 98% of prior PI failures) had IL-28B rs12979860 non-CC genotypes.
Slovenian: Večina bolnikov (71 %, vključno z 98 % bolnikov z neuspešnim predhodnim zdravljenjem z zaviralcem proteaze) je imela ne-CC genotipe IL-28B rs12979860.
English: For 11 patients, cirrhosis status was missing or inconclusive (FibroTest score >0.48 to
Slovenian: Pri 11 bolnikih je podatek o stanju ciroze manjkal ali pa iz podatkov o cirozi ni bilo mogoče sklepati (ocena FibroTesta > 0,48 do < 0,75 ali APRI > 1 do ≤ 2).
English: Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road
Slovenian: Imetnik dovoljenja za promet z zdravilom Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road
English: AI444043 was an open-label, single-arm study of daclatasvir with pegIFN/RBV in treatment-naïve adults with chronic HCV genotype 1 infection who were co-infected with HIV.
Slovenian: Študija AI444043 je bila odprta, enoskupinska študija uporabe daklatasvirja v kombinaciji s pegIFN/RBV pri zdravljenju predhodno še nezdravljenih odraslih bolnikov s kronično okužbo z genotipom 1 HCV in sočasno okužbo z virusom HIV.
English: Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets Daklinza 90 mg film-coated tablets daclatasvir
Slovenian: Daklinza 30 mg filmsko obložene tablete Daklinza 60 mg filmsko obložene tablete Daklinza 90 mg filmsko obložene tablete
English: No cirrhosis With cirrhosis** Genotype 1 1a 1b Genotype 2 Genotype 3 Genotype 4 Virologic failure Detectable HCV RNA at end of treatment Relapse Missing post-treatment data
Slovenian: Konec zdravljenja HCV RNA nezaznavna SVR12 Brez ciroze** S cirozo** Genotip 1 1a 1b Genotip 2 Genotip 3 Genotip 4 Virusni neodziv Zaznavna raven HCV RNA ob koncu zdravljenja Ponovitev
English: No dose adjustment of Daklinza or azithromycin or ciprofloxacin is required.
Slovenian: Odmerka zdravila Daklinza, azitromicina ali ciprofloksacina ni treba prilagajati.
English: End of treatment HCV RNA undetectable SVR12
Slovenian: Konec zdravljenja HCV RNA nezaznavna SVR12
English: HCV Treatmentexperienced*
Slovenian: HCV, predhodno zdravljenje*
English: Coadministration of Daklinza with systemic dexamethasone or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Slovenian: Daklinza s sistemskim deksametazonom ali z drugimi močnimi induktorji CYP3A4 je kontraindicirana (glejte poglavje 4.3).
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Slovenian: Neželeni učinki so v tabeli 5 navedeni po režimu zdravljenja, organskih sistemih in pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do
English: No dose adjustment of midazolam, other benzodiazepines or other CYP3A4 substrates is required when coadministered with Daklinza.
Slovenian: Daklinza odmerka midazolama, drugih benzodiazepinov ali drugih substratov za CYP3A4 ni treba prilagajati.
English: ANTICOAGULANTS Dabigatran etexilate
Slovenian: ANTIKOAGULANSI Dabigatran eteksilat
English: Dose recommendation for concomitant medicines Strong inhibitors of cytochrome P450 enzyme 3A4 (CYP3A4) The dose of Daklinza should be reduced to 30 mg once daily when coadministered with strong inhibitors of CYP3A4.
Slovenian: Močni zaviralci encima 3A4 citokroma P450 (CYP3A4) Pri sočasni uporabi močnih zaviralcev CYP3A4 je treba odmerek zdravila Daklinza zmanjšati na 30 mg enkrat na dan.
English: ↔ Daclatasvir*
Slovenian: ↔ Lopinavir*
English: ↔ Daclatasvir ↔ Warfarin
Slovenian: Pričakovano: ↔ Daklatasvir ↔ Varfarin
English: No metabolites circulated at levels more than 5% of the parent concentration.
Slovenian: Ugotovljena količina presnovkov v obtoku ni presegala 5 %
English: No dose adjustment of Daklinza 60 mg once daily, darunavir/ritonavir (800/100 mg once daily or 600/100 mg twice daily) or darunavir/cobicistat is required.
Slovenian: Odmerka zdravila Daklinza (60 mg enkrat na dan), darunavirja/ritonavirja (800/100 mg enkrat na dan ali 600/100 mg dvakrat na dan) ali darunavirja/kobicistata ni treba prilagajati.
English: The table is not all-inclusive.
Slovenian: V tabeli niso navedene vse interakcije.
English: Pack size of 28 film-coated tablets in non-perforated calendar blisters.
Slovenian: Velikost pakiranja: 28 filmsko obloženih tablet v neperforiranih koledarskih pretisnih omotih.
English: Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for
Slovenian: ** Ciroza je bila pri 14 bolnikih določena z biopsijo jeter (METAVIR F4), pri 11 bolnikih z metodo FibroScan
English: Luxembourg/Luxemburg N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Slovenian: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see section 5.2).
Slovenian: Pri bolnikih s katero koli stopnjo okvare ledvic odmerka zdravila Daklinza ni treba prilagajati (glejte poglavje 5.2).
English: Daklinza + sofosbuvir (without ribavirin) for 24 weeks
Slovenian: Daklinza + sofosbuvir (brez ribavirina) 24 tednov
English: Do not chew or crush the tablet as it has a very unpleasant taste.
Slovenian: Tableta je zelo neprijetnega okusa, zato je ne smete žvečiti ali drobiti.
English: All patients Cirrhosis
Slovenian: Vsi bolniki Ciroza
English: Buprenorphine/naloxone, 8/2 mg to 24/6 mg once daily individualized dose* (daclatasvir 60 mg once daily)
Slovenian: Buprenorfin/nalokson, od 8/2 mg do 24/6 mg enkrat na dan, individualizirani odmerek* (daklatasvir 60 mg enkrat na dan)
English: Daklinza in combination with sofosbuvir
Slovenian: Daklatasvir v kombinaciji s sofosbuvirjem
English: Patients originally assigned to placebo and those in the daclatasvir group who did not achieve HCV RNA <LLOQ at Week 4 and undetectable at Week 10 continued pegIFN/RBV to complete 48 weeks of treatment.
Slovenian: Bolniki, ki so bili prvotno razporejeni v skupino s placebom in bolniki v skupini z daklatasvirjem, ki v 4. tednu niso dosegli vrednost HCV RNA < LLOQ in nezaznavne ravni v 10. tednu, so nadaljevali zdravljenje s pegIFN/RBV celotno 48-tedensko obdobje zdravljenja.
English: CYP3A4 inhibition by ketoconazole
Slovenian: Zaviranje CYP3A4 s ketokonazolom.
English: Calcium channel blockers Diltiazem
Slovenian: Zaviralci kalcijevih kanalčkov
English: ↔ Daclatasvir ↔ Immunosuppressant
Slovenian: Pričakovano: ↔ Daklatasvir ↔ Imunosupresiv
English: Patients without cirrhosis
Slovenian: Bolniki brez ciroze
English: Very common (may affect more than 1 in 10 people): decreased appetite difficulty sleeping headache shortness of breath nausea fatigue flu-like illness, fever itching, dry skin, unusual hair loss or thinning, rash diarrhoea cough joint pain, aching or tender muscles, not caused by exercise, unusual weakness irritability reduction in red blood cells (anaemia), reduction in white blood cells
Slovenian: zmanjšanje apetita težave s spanjem glavobol oteženo dihanje siljenje na bruhanje utrujenost gripi podobna bolezen, zvišana telesna temperatura srbenje, suha koža, neobičajno izpadanje ali redčenje las, izpuščaj driska kašelj bolečina v sklepih, bolečina ali občutljivost v mišicah, ki nista posledica telesne aktivnosti, nenavadna oslabelost razdražljivost zmanjšanje števila rdečih krvnih celic (anemija), zmanjšanje števila belih krvnih celic
English: Impact of baseline NS5A RAVs on cure rates
Slovenian: Vpliv izhodiščnih RAV NS5A na deleže ozdravitve
English: In the cirrhosis cohort, 4 patients with hepatocellular carcinoma underwent liver transplantation after 1-71 days of treatment; 3 of the 4 patients received 12 weeks of post-liver transplant treatment extension and 1 patient, treated for 23 days before transplantation, did not receive treatment extension.
Slovenian: Trije od teh 4 bolnikov so se po presaditvi zdravili v 12-tedenskem podaljšku, 1 bolnik, ki se je zdravil 23 dni pred presaditvijo, pa se v podaljšku ni zdravil.
English: When Daklinza is used together with peginterferon alfa and ribavirin the reported side effects are the same as those listed in the package leaflets for these medicines.
Slovenian: Pri uporabi zdravila Daklinza skupaj s peginterferonom alfa in z ribavirinom so poročali o enakih neželenih učinkih, kot so navedeni v navodilih za uporabo teh zdravil.
English: Cirrhosis status was not reported for four patients in the daclatasvir + pegIFN/RBV group.
Slovenian: Pri štirih bolnikih v skupini z daklatasvirjem + pegIFN/RBV o statusu ciroze niso poročali.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily (daclatasvir 60 mg once daily/120 mg once daily)
Slovenian: Nenukleozidni zaviralci reverzne transkriptaze (NNRTI-ji) Efavirenz 600 mg enkrat na dan (daklatasvir 60 mg enkrat na dan/120 mg enkrat na dan)
English: With some of these medicines, your doctor may need to adjust your dose of Daklinza.
Slovenian: Pri sočasni uporabi nekaterih navedenih zdravil bo zdravnik odmerek zdravila Daklinza morda moral prilagoditi.
English: For HCV genotype specific activity, see sections 4.4 and 5.1.
Slovenian: Za specifično aktivnost proti genotipom HCV glejte poglavji 4.4 in 5.1. 4.2 Odmerjanje in način uporabe
English: Digoxin should be used with caution when coadministered with Daklinza.
Slovenian: Pri uporabi digoksina skupaj z zdravilom Daklinza je potrebna previdnost.
English: In dogs, bone marrow hypocellularity with correlating clinical pathology changes were observed at exposures 9-fold the clinical AUC exposure.
Slovenian: Pri psih so pri izpostavljenosti, ki je bila na osnovi vrednosti AUC 9-krat večja od izpostavljenosti pri klinični uporabi, opazili hipocelularnost kostnega mozga s pripadajočimi kliničnimi patološkimi spremembami.
English: ANTIDEPRESSANTS Selective serotonin reuptake inhibitors Escitalopram 10 mg once daily (daclatasvir 60 mg once daily)
Slovenian: Selektivni zaviralci prevzema serotonina Escitalopram 10 mg enkrat na dan (daklatasvir 60 mg enkrat na dan)
English: Patients with CP C cirrhosis
Slovenian: Bolniki s cirozo CP C
English: 0.180/0.215/0.250 mg once daily for 7/7/7 days (daclatasvir 60 mg once daily)
Slovenian: Etinilestradiol 35 μg enkrat na dan 21 dni + norgestimat 0,180/0,215/0,250 mg enkrat na dan 7/7/7 dni (daklatasvir 60 mg enkrat na dan)
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1) HCV GT 3
Slovenian: Daklinza + sofosbuvir +/- ribavirin 24 tednov (glejte poglavji 4.4 in 5.1) GT 3 HCV
English: Methadone, 40-120 mg once daily individualized dose* (daclatasvir 60 mg once daily)
Slovenian: Metadon, 40 do 120 mg enkrat na dan, individualizirani odmerek* (daklatasvir 60 mg enkrat na dan)