FrancophonIA/ELRC3.0 huggingface dataset:
English: To stimulate active immunity of sheep and cattle against bluetongue virus serotypes 1, 4 and/ or 8 related to those contained in the vaccine (combination of maximum 2 serotypes).
Slovenian: Za spodbujanje aktivne imunosti ovc in goveda proti serotipom 1, 4 in/ali 8 virusa bolezni modrikastega jezika, povezanim s serotipi, ki jih vsebuje cepivo (kombinacija največ dveh serotipov).
English: - Primary vaccination: administer a single 2 ml dose
Slovenian: - osnovno cepljenje: en 2-mililitrski odmerek;
English: Special precautions for use in animals
Slovenian: Indikacije za uporabo pri ciljnih živalskih vrstah
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko.
English: Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1
Slovenian: serotip 1 (BTV-1), sev ALG2006/01 E1
English: After administration of a double dose, no other adverse reactions different to those mentioned in section 4.6 were observed.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po dajanju dvojnega odmerka niso opazili drugih neželenih učinkov, ki bi bili drugačni od neželenih učinkov, navedenih v poglavju 4.6.
English: Inactivated bluetongue virus, serotype 1 (BTV-1), strain ALG2006/01 E1 RP* ≥ 1 Inactivated bluetongue virus, serotype 4 (BTV-4), strain BTV-4/SPA-1/2004 RP* ≥ 1 Inactivated bluetongue virus, serotype 8 (BTV-8), strain BEL2006/01
Slovenian: RP** ≥ 1 * Največ dva različna serotipa inaktiviranega virusa bolezni modrikastega jezika: inaktiviran virus bolezni modrikastega jezika, serotip 1 (BTV-1), sev ALG2006/01 E1; inaktiviran virus bolezni modrikastega jezika, serotip 4 (BTV-4), sev BTV-4/SPA-1/2004; inaktiviran virus bolezni modrikastega jezika, serotip 8 (BTV-8), sev BEL2006/01.
English: - Primary vaccination: administer two doses of 4 ml 3 weeks apart
Slovenian: - osnovno cepljenje: dva 4-mililitrska odmerka v razmiku treh tednov;
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovenian: Vrsta ovojnine in vsebina
English: - Revaccination: administer one dose of 2 ml after 12 months.
Slovenian: - obnovitveno cepljenje: en 2-mililitrski odmerek po 12 mesecih.
English: For active immunisation of sheep to prevent viraemia* and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and clinical signs and lesions caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
Slovenian: Za aktivno imunizacijo ovc za preprečevanje viremije* in zmanjšanje kliničnih znakov in lezij, ki jih povzročata serotipa 1 in/ali 8 virusa bolezni modrikastega jezika, in/ali za zmanjšanje viremije* in kliničnih znakov in lezij, ki jih povzroča serotip 4 virusa bolezni modrikastega jezika (kombinacija največ dveh serotipov).
English: - Revaccination: administer one dose of 4 ml after 12 months.
Slovenian: - obnovitveno cepljenje: en 4-mililitrski odmerek po 12 mesecih.
English: Special precautions for use in animals:
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Ni smiselno.
English: For active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).
Slovenian: Za aktivno imunizacijo goveda za preprečevanje viremije*, ki jo povzročata serotipa 1 in/ali 8 virusa bolezni modrikastega jezika, in/ali za zmanjšanje viremije*, ki jo povzroča serotip 4 virusa bolezni modrikastega jezika (kombinacija največ dveh serotipov).
English: Cardboard box with 1 vial containing 80 ml.
Slovenian: Kartonska škatla z 1 vialo z 80 ml. Kartonska škatla z 1 vialo z 200 ml.
English: Medicines should not be disposed of via wastewater or household waste.
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Ne odvrzite zdravila v odpadno vodo ali med gospodinjske odpadke.
English: Vial of 80 ml Vial of 200 ml
Slovenian: Viala z 200 ml
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN En ml vsebuje:
English: 4.6 Adverse reactions (frequency and seriousness)
Slovenian: Neželeni učinki (pogostost in resnost) Zelo pogost je pojav lokalnih reakcij na mestu injiciranja po cepljenju.
English: - Primary vaccination: administer two doses of 4 ml 3 weeks apart.
Slovenian: - osnovno cepljenje: dva 4-mililitrska odmerka v razmiku treh tednov; - obnovitveno cepljenje: en 4-mililitrski odmerek po 12 mesecih.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: V primeru nenamernega samoinjiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko.
English: Regimen and duration
Slovenian: Režim in trajanje
English: Do not take a double dose (two doses close together).
Slovenian: Ne vzemite dvojnega odmerka (dveh odmerkov
English: None of these effects have been observed in humans.
Slovenian: Nobenega od teh učinkov niso opazili
English: * Includes patients co-infected with human immunodeficiency virus (HIV).
Slovenian: * Vključno z bolniki s sočasno okužbo z virusom humane imunske pomanjkljivosti (HIV).
English: Data are available from a completed follow-up study to assess durability of response for approximately 3 years after treatment with daclatasvir.
Slovenian: Na voljo so podatki iz zaključene študije, ki je vrednotila trajanje odziva približno do 3 let po zdravljenju z daklatasvirjem.
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Slovenian: Bolnike, pri katerih se ugotovi veliko tveganje za bradiaritmijo, je treba 48 ur neprekinjeno spremljati v ustrezni klinični
English: What you need to know before you take Daklinza
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Daklinza
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: If you forget to take Daklinza It is important not to miss a dose of this medicine.
Slovenian: Če ste pozabili vzeti zdravilo Daklinza Pomembno je, da odmerka tega zdravila ne pozabite vzeti.
English: If you have any of these side effects, do not drive or use any tools or machines.
Slovenian: V primeru pojava takšnih neželenih učinkov ne smete voziti vozil ali upravljati z orodji ali s stroji.
English: Recurrent HCV infection post-liver transplant (GT 1, 3 or 4)
Slovenian: Ponovitev okužbe s HCV po presaditvi jeter (GT 1, 3 ali 4)
English: Do not stop taking Daklinza unless your
Slovenian: Ne prenehajte z jemanjem zdravila Daklinza, razen če
English: *results are dose-normalised to 60 mg
Slovenian: *Rezultati so normirani na 60-mg odmerek.
English: ** One patient considered a protocol failure (non-SVR) achieved SVR *** NS5A RAVs monitored at amino acid positions are 28, 29, 30, 31, 32, 58, 62, 92, and 93
Slovenian: ** Pri enem bolniku SVR ni bil dosežen zaradi neupoštevanja protokola (brez-SVR) *** Nadzirane RAV NS5A na aminokislinskih pozicijah so 28, 29, 30, 31, 32, 58, 62, 92 in 93.
English: What Daklinza is and what it is used for 2.
Slovenian: Kaj je zdravilo Daklinza in za kaj ga uporabljamo 2.
English: Seventy-seven (77 [98.7%]) of treated patients in this study were infected with HCV GT-3a, and 1 patient (1.3%) was infected with HCV GT-3b.
Slovenian: Sedeminsedemdeset (77 [98,7 %]) bolnikov, zdravljenih v tej študiji, je imelo okužbo z GT-3a HCV, 1 bolnik (1,3 %) pa je imel okužbo z GT-3b HCV.
English: The expiry date refers to the last day of that month.
Slovenian: Rok uporabnosti zdravila se izteče na zadnji dan navedenega
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP07
Slovenian: Farmakoterapevtska skupina: Zdravila z direktnim delovanjem na viruse, oznaka ATC: J05AP07
English: The European Medicines Agency has deferred the obligation to submit the results of studies with daclatasvir in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z daklatasvirjem za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: As liver function may change during treatment with Daklinza, a close monitoring of International Normalized Ratio (INR) values is recommended.
Slovenian: Ker se delovanje jeter v času zdravljenja z zdravilom Daklinza lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR).
English: Adverse reactions are listed in Table 5 by regimen, system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
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 < 1/1.000) in zelo redki (< 1/10.000).
English: Treatment outcomes in study AI444042 are presented in Table 14.
Slovenian: Izidi zdravljenja v študiji AI444042 so prikazani v tabeli 14.
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Daklinza in
Slovenian: Zaradi dolge razpolovne dobe amiodarona je treba ustrezno spremljati tudi bolnike, ki so prekinili zdravljenje z amiodaronom v zadnjih nekaj mesecih in bodo začeli zdravljenje z zdravilom Daklinza v
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Slovenian: Pri bolnikih s sočasno okužbo s HBV/HCV obstaja tveganje za reaktivacijo HBV, zato jih je treba spremljati in zdraviti po trenutno veljavnih kliničnih
English: This lowers the amount of hepatitis C virus in your body and removes the virus from your blood over a
Slovenian: Na ta način zmanjša količino virusa hepatitisa C v telesu in sčasoma virus odstrani iz krvi.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje
English: Tell your doctor if any of the following applies: you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this you have a current or previous infection with the hepatitis B virus, since your doctor may want to your liver is damaged and not functioning properly (decompensated liver disease) you have diabetes.
Slovenian: Povejte zdravniku, če se kar koli od naslednjega nanaša na vas: jemljete ali ste v zadnjih nekaj mesecih jemali zdravilo amiodaron za zdravljenje nerednega srčnega utripa (če jemljete ali ste jemali to zdravilo, bo zdravnik morda razmislil o drugih če imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno če imate okvaro jeter, zaradi katere jetra ne delujejo pravilno (dekompenzirana bolezen jeter).
English: Because daclatasvir is highly protein bound (99%) and has a molecular weight >500, dialysis is unlikely to significantly reduce plasma concentrations of daclatasvir.
Slovenian: Ker se daklatasvir močno veže na beljakovine (99 %), njegova molekulska masa pa je > 500, je malo verjetno, da bi dializa pomembneje zmanjšala koncentracije
English: The most frequently reported adverse reactions were fatigue, headache, and nausea.
Slovenian: Najpogosteje poročani neželeni učinki so bili utrujenost, glavobol in navzea.
English: SVR12 was achieved by 83% (50/60) of patients in the cirrhosis cohort, with a marked difference between patients with Child-Pugh A or B (92-94%) as compared to those with Child-Pugh C and 94% of patients in the post-liver transplant cohort (Table 9).
Slovenian: SVR12 je bil dosežen pri 83 % (50/60) bolnikov v kohorti s cirozo, z izrazito razliko med bolniki s Child-Pugh A ali B (92-94 %) v primerjavi z bolniki s Child-Pugh C in pri 94 % bolnikov v kohorti po presaditvi jeter (tabela 9).
English: Patients with HCV infection (across genotypes) at high risk of decompensation or death within 12 months if left untreated were treated under compassionate use programmes.
Slovenian: Bolnike z okužbo s HCV (kateri koli genotip) in visokim tveganjem za dekompenzacijo ali smrt v 12 mesecih brez zdravljenja so zdravili v programih sočutne uporabe zdravila.
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Slovenian: Za priporočene režime pri različnih genotipih HCV glejte poglavje 4.2.
English: Following single-dose oral administration of 14C-daclatasvir in healthy subjects, 88% of total radioactivity was recovered in feces (53% as unchanged drug) and 6.6% was excreted in the urine (primarily as unchanged drug).
Slovenian: Po enkratnem peroralnem odmerku z radioaktivnim izotopom 14C označenega daklatasvirja se je pri zdravih osebah 88 % celotne radioaktivnosti izločilo z blatom (53 % v obliki nespremenjenega zdravila), 6,6 % pa z urinom (v glavnem v nespremenjeni obliki).
English: No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective
Slovenian: Klinično pomembne protivirusne aktivnosti proti različnim RNA in DNA virusom, vključno z virusom HIV, niso opazili, kar potrjuje, da je daklatasvir, ki zavira za HCV specifično tarčo, zelo selektiven za HCV.
English: General disorders and administration site conditions fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost
English: ↔ Daclatasvir AUC: ↔*
Slovenian: ↔ Daklatasvir AUC: ↔*
English: The pharmacokinetics of daclatasvir in paediatric patients have not been evaluated.
Slovenian: Farmakokinetike daklatasvirja pri pediatričnih bolnikih niso vrednotili.
English: If you accidentally take more Daklinza tablets than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Slovenian: Če ste vzeli večji odmerek zdravila Daklinza, kot bi smeli Če ste pomotoma vzeli več tablet zdravila Daklinza kot bi smeli, se nemudoma posvetujte s svojim zdravnikom ali poiščite zdravniško pomoč v najbližji bolnišnici.
English: In vitro and in vivo studies demonstrate that daclatasvir is a substrate of CYP3A, with CYP3A4 being the major CYP isoform responsible for the metabolism.
Slovenian: In vitro ter in vivo študije kažejo, da je daklatasvir substrat za CYP3A, pri čemer je CYP3A4 glavna izooblika CYP, odgovorna za presnovo.
English: EU/1/14/939/001 28 tablets (calendar pack)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/001 28 tablet (koledarsko pakiranje)
English: Cirrhotic cohort N=60
Slovenian: Kohorta s cirozo N=60
English: The efficacy and safety of daclatasvir 60 mg once daily in combination with sofosbuvir 400 mg once daily in the treatment of patients with chronic HCV infection were evaluated in five open-label studies (AI444040, ALLY-1, ALLY-2, ALLY-3, and ALLY-3C).
Slovenian: Učinkovitost in varnost daklatasvirja v odmerku 60 mg enkrat na dan v kombinaciji s sofosbuvirjem v odmerku 400 mg enkrat na dan pri zdravljenju bolnikov s kronično okužbo s HCV so vrednotili v petih odprtih študijah (AI444040, ALLY-1, ALLY-2, ALLY-3 in ALLY-3C).
English: Total N=78
Slovenian: Skupaj N=78
English: In phase 1 clinical studies, healthy subjects who received up to 100 mg once daily for up to 14 days or single doses up to 200 mg had no unexpected adverse reactions.
Slovenian: V kliničnih študijah 1. faze uporaba odmerkov do 100 mg enkrat na dan v trajanju 14 dni ali enkratnih odmerkov do 200 mg pri zdravih osebah ni bila povezana s pojavom nepričakovanih neželenih
English: What Daklinza looks like and contents of the pack
Slovenian: Izgled zdravila Daklinza in vsebina pakiranja
English: In vitro daclatasvir is an inhibitor of renal uptake transporters, OAT1 and 3, and OCT2, but is not expected to have a clinical effect on the pharmacokinetics of substrates of these transporters.
Slovenian: Daklatasvir je in vitro zaviralec ledvičnih prenašalcev privzema, OAT1 in 3 ter OCT2, vendar pa kliničnega učinka na farmakokinetiko substratov za te prenašalce ne
English: EU/1/14/939/003 28 tablets (calendar pack)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/939/003 28 tablet (koledarsko pakiranje)
English: NARCOTIC ANALGESICS Buprenorphine/naloxone, 8/2 mg to 24/6 mg once daily
Slovenian: NARKOTIČNI ANALGETIKI Buprenorfin/nalokson, od 8/2 mg do 24/6 mg enkrat na
English: Close monitoring of INR values is recommended with all vitamin K antagonists.
Slovenian: Pri vseh antagonistih vitamina K se priporoča natančno spremljanje vrednosti INR.
English: This medicine contains less than 1 mmol sodium (23 mg) per maximum dose of 90 mg, that is to say
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na največji odmerek 90 mg, kar v bistvu pomeni
English: All patients receiving Daklinza and sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Slovenian: Vse bolnike, ki prejemajo zdravilo Daklinza in sofosbuvir v kombinaciji z amiodaronom in drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, je treba prav tako opozoriti na simptome bradikardije in srčnega bloka ter jim svetovati, naj ob pojavu simptomov takoj poiščejo zdravniško
English: Daclatasvir was excreted into the milk of lactating rats with concentrations 1.7- to 2-fold maternal
Slovenian: Daklatasvir se je izločal v mleko doječih podgan v koncentracijah, ki so bile od 1,7-krat do 2-krat
English: Due to the lack of data, coadministration of Daklinza and etravirine or nevirapine is not recommended.
Slovenian: Zaradi pomanjkanja podatkov sočasna uporaba zdravila Daklinza in etravirina ali nevirapina ni priporočljiva.
English: No metabolites circulated at levels more than 5% of the parent concentration.
Slovenian: Ugotovljena količina presnovkov v obtoku ni presegala 5 % koncentracije izhodne učinkovine.
English: ** Other non-responders included 4 patients with HCV RNA < LLOQ target not detected (TND) at end of treatment, but who were lost to follow-up at post-treatment Week 12 and subsequent time points, and 1 patient who had no on-treatment HCV RNA results due to early discontinuation.
Slovenian: ** Neuspeh iz drugih razlogov vključuje 4 bolnike, pri katerih ciljna vrednost HCV RNA < LLOQ ob koncu zdravljenja ni bila dokazana (target not detected - TND), vendar pa 12. teden po koncu zdravljenja in v vseh kasnejših časovnih točkah niso bili na voljo za spremljanje, in 1 bolnika, pri katerem rezultati HCV RNA med zdravljenjem zaradi zgodnjega prenehanja zdravljenja niso bili znani.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bristol-Myers Squibb Pharma EEIG
English: The safety and efficacy of Daklinza in children and adolescents aged below 18 years have not yet been
Slovenian: Varnost in učinkovitost zdravila Daklinza pri otrocih in mladostnikih, mlajših od 18 let, še nista bili
English: Very common (may affect more than 1 in 10 people): headache, nausea (feeling sick), fatigue reduction in red blood cells (anaemia) Common (may affect up to 1 in 10 people):
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): glavobol, navzea (siljenje na bruhanje), utrujenost zmanjšanje števila rdečih krvnih celic (anemija)
English: The SVR12 rates were achieved by 88.5% of patients, including 92.6% of treatment-naïve and 79.2% of treatment-experienced patients (see Table 13).
Slovenian: SVR12 je bil dosežen pri 88,5 % bolnikov, vključno z 92,6 % pri predhodno še nezdravljenih bolnikih in 79,2 % pri predhodno že zdravljenih bolnikih (glejte tabelo 13).
English: HCV RNA values in the ALLY-3C (AI444379) study were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test (version 2.0), with an LLOQ of 15 IU/mL.
Slovenian: V študiji ALLY-3C (AI444379) so vrednosti HCV RNA izmerili s testom Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV (različica 2.0), z LLOQ 15 i.e./ml.
English: In the majority of clinical studies of daclatasvir in combination with sofosbuvir or with peginterferon alfa and ribavirin, plasma HCV RNA values were measured using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System, with a lower limit of quantification (LLOQ) of 25 IU/ ml.
Slovenian: V večini kliničnih študij daklatasvirja v kombinaciji s sofosbuvirjem ali peginterferonom alfa in ribavirinom, so vrednosti HCV RNA v plazmi izmerili s testom COBAS TaqMan HCV (različica 2.0) v visoko prečiščenem sistemu, s spodnjo mejo kvantifikacije (LLOQ - lower limit of quantification) 25 i.e./ml.
English: daclatasvir monotherapy for 14 days.
Slovenian: monoterapiji 14 dni.
English: Grade 3/4 increases in total bilirubin were observed in 5% of patients (all in patients with HIV coinfection who were receiving concomitant atazanavir, with Child-Pugh A, B, or C cirrhosis, or who
Slovenian: O povečanju vrednosti skupnega bilirubina stopnje 3/4 so poročali pri 5 % bolnikov (vsa ta povečanja so bila pri bolnikih s sočasno okužbo z virusom HIV, ki so sočasno prejemali atazanavir, s cirozo Child-Pugh A, B ali C ali po presaditvi
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e. treatment stopping rules) are
Slovenian: Mejne vrednosti HCV RNA, ki so razlog za ukinitev zdravljenja (pravila za ukinitev zdravljenja), so predstavljena v tabeli 3.
English: HCV replicons expressing daclatasvir-associated resistance substitutions remained fully sensitive to interferon alfa and other anti-HCV agents with different mechanisms of action, such as NS3 protease and NS5B polymerase (nucleoside and non-nucleoside) inhibitors.
Slovenian: Replikoni HCV s substitucijami, povezanimi z odpornostjo proti daklatasvirju, so ostali popolnoma občutljivi za interferon alfa in druga zdravila proti HCV, ki imajo drugačen mehanizem delovanja, kot so zaviralci proteaze NS3 in zaviralci polimeraze NS5B (nukleozidni in nenukleozidni).
English: * Patients who had missing data at follow-up Week 12 were considered responders if their next available HCV RNA value was <LLOQ.
Slovenian: * Bolniki z manjkajočim podatkom pri obisku v 12. tednu so bili obravnavani kot bolniki z odzivom, če je bila naslednja razpoložljiva vrednost HCV RNA manjša od LLOQ.
English: Table 4: Interactions and dose recommendations with other medicinal products Medicinal products by therapeutic areas
Slovenian: Tabela 4: Interakcije in priporočila za odmerjanje pri sočasni uporabi drugih zdravil Zdravila po terapevtskih področjih
English: The efficacy of Daklinza as part of a retreatment regimen in patients with prior exposure to a NS5A
Slovenian: Učinkovitosti zdravila Daklinza kot del režima ponovne uvedbe zdravljena pri bolnikih, predhodno zdravljenih z zaviralcem NS5A, niso ugotovili.