FrancophonIA/ELRC3.0 huggingface dataset:
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 and GS-331007 is not an inhibitor of OAT1, OCT2 and MATE1.
Slovenian: Sofosbuvir in GS-331007 nista zaviralca prenašalcev P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 in GS-331007 ni zaviralec OAT1, OCT2 in
English: Sofosbuvir and GS-331007 are not inhibitors or inducers of CYP or uridine diphosphate glucuronosyltransferase (UGT) 1A1 enzymes.
Slovenian: Sofosbuvir in GS-331007 nista zaviralca ali induktorja encimov CYP ali uridin-difosfatglukuroniltransferaze (UGT) 1A1.
English: The pharmacokinetics of ledipasvir, sofosbuvir, and GS-331007 have not been established in paediatric patients aged < 12 years (see section 4.2).
Slovenian: Farmakokinetike ledipasvirja, sofosbuvirja in GS-331007 pri pediatričnih bolnikih, starih < 12 let, niso ugotavljali (glejte poglavje 4.2).
English: Harvoni can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Slovenian: Harvoni se lahko pri teh bolnikih uporablja brez prilagajanja odmerka, ko druge ustrezne možnosti zdravljenja niso na voljo (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
English: A NS5B substitution E237G was detected in 3 patients (1 genotype 1b and 2 genotype 1a) in the Phase 3 studies (ION-3, ION-1 and ION-2) and 3 patients with genotype 1a infection in the SOLAR-1 and SOLAR-2 studies at the time of relapse.
Slovenian: Substitucijo E237G v polimerazi NS5B so odkrili pri 3 bolnikih (1 z genotipom 1b in 2 z genotipom 1a) v študijah 3. faze (ION-3, ION-1 in ION-2) in 3 bolnikih z okužbo genotipa 1a v študijah SOLAR-1 in SOLAR-2 v času relapsa.
English: In clinical studies, fatigue and headache were more common in patients treated with ledipasvir/sofosbuvir compared to placebo.
Slovenian: V kliničnih študijah sta bila utrujenost in glavobol pri bolnikih, ki so bili zdravljeni z ledipasvirjem/sofosbuvirjem, v primerjavi s placebom bolj pogosta.
English: As a precautionary measure, it is preferable to avoid the use of Harvoni during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Harvoni bolje izogibati.
English: • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Slovenian: Sofosbuvir je pan-genotipski zaviralec RNA polimeraze HCV NS5B, odvisne od RNA, ki je bistvena za replikacijo virusa.
English: Neither ledipasvir nor sofosbuvir are substrates for hepatic uptake transporters, organic cation transporter (OCT) 1, organic anion-transporting polypeptide (OATP) 1B1 or OATP1B3.
Slovenian: Niti ledipasvir niti sofosbuvir nista substrata za prenašalce jetrnega privzema, prenašalca organskih kationov (OCT-organic cation transporter) 1, prenašalca transportnega polipeptida organskih anionov (OATP-organic anion-transporting polypeptide) 1B1 ali OATP1B3.
English: The 8-week treatment of ledipasvir/sofosbuvir without ribavirin was non-inferior to the 8-week treatment of ledipasvir/sofosbuvir with ribavirin (treatment difference 0.9%; 95% confidence interval: -3.9% to 5.7%) and the 12-week treatment of ledipasvir/sofosbuvir (treatment difference -2.3%; 97.5% confidence interval: -7.2% to 3.6%).
Slovenian: 8-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem brez ribavirina ni bilo inferiorno 8-tedenskemu zdravljenju z ledipasvirjem/sofosbuvirjem z ribavirinom (razlika v zdravljenju 0,9 %; 95-odstotni interval zaupanja: -3,9 % do 5,7 %) in 12-tedenskemu zdravljenju z ledipasvirjem/sofosbuvirjem (razlika v zdravljenju -2,3 %; 97,5-odstotni interval zaupanja: -7,2 % do 3,6 %).
English: Adult and adolescent patients 12 years of age or older with genotype 1, 4, 5 or 6 CHC Patients without cirrhosis
Slovenian: Odrasli bolniki in mladostniki, stari 12 let ali starejši, s CHC genotipa 1, 4, 5 ali 6 Bolniki brez ciroze
English: In a rat pre- and postnatal study, at a maternally toxic dose, the developing rat offspring exhibited mean decreased body weight and body weight gain when exposed in utero (via maternal dosing) and during lactation (via maternal milk) at a maternal exposure 4 times the exposure in humans at the recommended clinical dose.
Slovenian: V študijah pri podganah pred kotitvijo in po kotitvi so imeli pri odmerkih, toksičnih za mater, potomci podgan v razvoju povprečno manjšo telesno maso in manjši prirast telesne mase, če so bili izpostavljeni in utero (z dajanjem zdravila materi) in med laktacijo (prek materinega mleka) pri izpostavljenosti matere, ki je bila 4-krat višja od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku.
English: Your doctor will test your blood before, during and after your treatment with Harvoni.
Slovenian: Vaš zdravnik bo pred zdravljenjem z zdravilom Harvoni, med njim in po njem opravil krvne preiskave.
English: In the SOLAR-2 study, one patient with genotype 4d developed NS5B substitution E237G at the time of relapse.
Slovenian: V študiji SOLAR-2 se je v času relapsa pri enem bolniku z genotipom 4d pojavila substitucija E237G v polimerazi NS5B.
English: Medicinal products that increase gastric pH are expected to decrease concentration of ledipasvir.
Slovenian: Pričakuje se, da bodo zdravila, ki povečujejo vrednost pH v želodcu, zmanjšala koncentracijo ledipasvirja.
English: Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Slovenian: Pokazalo se je, da zdravilo Harvoni poveča izpostavljenost tenofovirju, zlasti, če se uporablja skupaj z režimom proti HIV, ki vsebuje dizoproksiltenofovirat fumarat in farmakokinetični ojačevalec (ritonavir ali kobicistat).
English: Table 3: Guidance for ribavirin dosing when administered with Harvoni to adolescents aged 12 to < 18 years.
Slovenian: Preglednica 3: Navodila za odmerjanje ribavirina pri dajanju z zdravilom Harvoni mladostnikom, starim od 12 do < 18 let.
English: However, patients should be advised that fatigue was more common in patients treated with ledipasvir/sofosbuvir compared to placebo.
Slovenian: Vendar je treba bolnike opozoriti, da se je v primerjavi s placebom pri bolnikih, ki so bili zdravljeni z ledipasvirjem/sofosbuvirjem, utrujenost pojavljala bolj pogosto.
English: Interactions between Harvoni and other medicinal products
Slovenian: Interakcije med zdravilom Harvoni in drugimi zdravili
English: In the SIRIUS study (see “Clinical efficacy and safety”, below) 5 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with or without ribavirin.
Slovenian: V študiji SIRIUS (glejte spodnje poglavje »Klinična učinkovitost in varnost«) so pri 5 bolnikih z okužbo genotipa 1 po zdravljenju z ledipasvirjem/sofosbuvirjem z ribavirinom ali brez njega opazili relaps.
English: Similarly, there are presently no data to support the effectiveness of NS3/4A protease inhibitors in patients who previously failed prior therapy that included an NS3/4A protease inhibitor.
Slovenian: Podobno trenutno ni na voljo podatkov, ki bi podprli učinkovitost zaviralcev proteaze NS3/4A pri bolnikih, pri katerih zdravljenje, ki je vključevalo zaviralca proteaze NS3/4A, ni bilo uspešno.
English: The proportion of such baseline NS5A RAVs seen with deep sequencing varied from very low (cut off for assay = 1%) to high (main part of the plasma population).
Slovenian: Delež teh izhodiščnih RAV NS5A, ki so ga opazili s karakterizacijo strukture genoma, je segala od zelo majhnega (mejna vrednost testa = 1 %) do velikega (glavni del populacije plazme).
English: ACID REDUCING AGENTS
Slovenian: ZDRAVILA ZA ZMANJŠEVANJE KISLINE
English: Talk to your doctor or pharmacist before taking Harvoni if:
Slovenian: Pred začetkom jemanja zdravila Harvoni se posvetujte z zdravnikom ali farmacevtom, če:
English: In non-cirrhotic patients relapses only occurred in the presence of baseline NS5A RAVs, and during therapy with ledipasvir/sofosbuvir without ribavirin.
Slovenian: Pri bolnikih brez ciroze so se relapsi pojavili le v prisotnosti izhodiščnih RAV NS5A in med zdravljenjem z ledipasvirjem/sofosbuvirjem brez ribavirina.
English: TOTAL (n = 865)
Slovenian: SKUPAJ (n = 865)
English: The safety and efficacy of Harvoni in paediatric patients aged < 12 years have not been established.
Slovenian: Pediatrična populacija starosti < 12 let Varnost in učinkovitost zdravila Harvoni pri pediatričnih bolnikih, starih < 12 let, nista bili dokazani.
English: Co-administration of Harvoni with digoxin may increase the concentration of digoxin.
Slovenian: Sočasno dajanje zdravila Harvoni z digoksinom lahko poveča koncentracijo digoksina.
English: Table 16: Response rates in study ION-4
Slovenian: Preglednica 16: Stopnje odziva v študiji ION-4
English: Ribavirin dose*
Slovenian: Odmerek ribavirina*
English: The safety profile of ledipasvir/sofosbuvir with ribavirin for 12 or 24 weeks in adults with decompensated liver disease and/or those post-liver transplant was assessed in two open-label studies (SOLAR-1 and SOLAR-2).
Slovenian: Varnostni profil ledipasvirja/sofosbuvirja z ribavirinom 12 ali 24 tednov pri odraslih z dekompenzirano boleznijo jeter in/ali bolnikih po presaditvi jeter so ocenili v dveh odprtih študijah (SOLAR-1 in SOLAR-2).
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Slovenian: V primerjavi z bolniki z normalnim delovanjem jeter je bila vrednost AUC0-24 za sofosbuvir za 126 % višja pri zmerni jetrni okvari in za 143 % višja pri hudi jetrni okvari, medtem ko je bila vrednost AUC0-24 za GS-331007 višja za 18 % oz. 9 %.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to ledipasvir.
Slovenian: Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza (vključno z dekompenzirano cirozo) ni imela klinično pomembnega učinka na izpostavljenost ledipasvirju.
English: Reduced susceptibility to sofosbuvir was associated with the primary NS5B substitution S282T in all replicon genotypes examined.
Slovenian: Zmanjšana dovzetnost za sofosbuvir je bila povezana s primarno substitucijo S282T v polimerazi NS5B v vseh preučevanih genotipih replikona.
English: In patients who fail treatment with ledipasvir/sofosbuvir, selection of NS5A resistance mutations that substantially reduce the susceptibility to ledipasvir is seen in the majority of cases (see section 5.1).
Slovenian: Pri bolnikih, pri katerih zdravljenje z ledipasvirjem/sofosbuvirjem ni bilo uspešno, so v večini primerov opazili selekcijo mutacij odpornosti na zaviralec NS5A, ki pomembno znižajo dovzetnost za ledipasvir (glejte poglavje 5.1).
English: Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively due to the parent drug (> 98%).
Slovenian: Po enkratnem 90-miligramskem odmerku [14C]-ledipasvirja je bila sistemska izpostavljenost skoraj izključno posledica izhodiščne spojine (> 98 %).
English: Use with moderate P-gp inducers
Slovenian: Uporaba z zmernimi induktorji P-gp
English: • You or your partner must use an effective birth control method during treatment with Harvoni together with ribavirin and for some time afterwards.
Slovenian: • Vi ali vaš partner morate med zdravljenjem z zdravilom Harvoni skupaj z ribavirinom in še nekaj časa po njem uporabljati učinkovito metodo za preprečevanje nosečnosti.
English: Therefore, Harvoni should not be used during breast-feeding.
Slovenian: Zato se zdravila Harvoni med dojenjem ne sme uporabljati.
English: Ledipasvir had no adverse effects on mating and fertility.
Slovenian: Ledipasvir nima neželenih učinkov na parjenje in plodnost.
English: • If it's 18 hours or more after the time you usually take Harvoni, wait and take the next dose at your usual time.
Slovenian: • Če se tega spomnite več kot 18 ur od takrat, ko običajno vzamete zdravilo Harvoni, počakajte in vzemite naslednji odmerek ob običajnem času.
English: Medicinal products that are strong P-gp inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3).
Slovenian: Zdravila, ki so močni induktorji P-gp v črevesju (karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin in šentjanževka), lahko močno zmanjšajo koncentracije ledipasvirja in sofosbuvirja v plazmi, kar zmanjša terapevtski učinek ledipasvirja/sofosbuvirja, zato je njihova uporaba z zdravilom Harvoni kontraindicirana (glejte poglavje 4.3).
English: Co-administration will significantly decrease ledipasvir and sofosbuvir plasma concentrations and could result in loss of efficacy of Harvoni (see section 4.5).
Slovenian: Sočasna uporaba bo močno zmanjšala koncentracije ledipasvirja in sofosbuvirja v plazmi in lahko povzroči izgubo učinkovitosti zdravila Harvoni (glejte poglavje 4.5).
English: TOTAL (n = 647)
Slovenian: SKUPAJ (n = 647)
English: • outer cartons containing 1 bottle of 28 film-coated tablets
Slovenian: • škatle, ki vsebujejo 1 plastenko z 28 filmsko obloženimi tabletami
English: Like all medicines, this medicine may cause side effects.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Among patients with a baseline HCV RNA < 6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of ledipasvir/sofosbuvir and 96% (126/131) with 12-week treatment of ledipasvir/sofosbuvir.
Slovenian: Med bolniki z ravnijo HCV RNA ob izhodišču < 6 milijonov i.e./ml je bil SVR 97 % (119/123) z 8-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem in 96 % (126/131) z 12-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem.
English: If ribavirin is co-administered with Harvoni, the contraindications regarding use of ribavirin during pregnancy and breast-feeding apply (see also the Summary of Product Characteristics for ribavirin).
Slovenian: Pri sočasni uporabi ribavirina z zdravilom Harvoni obstajajo kontraindikacije za uporabo ribavirina med nosečnostjo in dojenjem (glejte tudi povzetek glavnih značilnosti zdravila za ribavirin).
English: Harvoni can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Slovenian: Zdravilo Harvoni se lahko pri teh bolnikih uporablja brez prilagajanja odmerka, če druge primerne možnosti zdravljenja niso na voljo (glejte poglavja 4.8, 5.1 in 5.2).
English: Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively.
Slovenian: Zaporedja NS5A in NS5B po izhodišču s podatki karakterizacije strukture genoma (deep sequencing) (mejna vrednost testa 1 %) so bila na voljo za 37 od 37 oz. 36 od 37
English: Table 13: Demographics and baseline characteristics in study ION-2 Patient disposition LDV/SOF 12 weeks (n = 109)
Slovenian: Preglednica 13: Demografske in izhodiščne značilnosti za študijo ION-2 Dispozicija bolnika LDV/SOF 12 tednov (n = 109)
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 80 years) analysed, age did not have a clinically relevant effect on the exposure to ledipasvir, sofosbuvir or GS-331007.
Slovenian: Populacijska farmakokinetična analiza pri bolnikih, okuženih s HCV, je pokazala, da znotraj analiziranega starostnega razpona (18 do 80 let) starost ni imela klinično pomembnega učinka na izpostavljenost ledipasvirju, sofosbuvirju ali GS-331007.
English: f Staggered administration (12 hours apart) of atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate or darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate and Harvoni provided similar results.
Slovenian: f. Uporaba z zamikom (12 ur kasneje) atazanavirja/ritonavirja + emtricitabina/dizoproksiltenofovirata fumarata ali darunavirja/ritonavirja + emtricitabina/dizoproksiltenofovirata fumarata in zdravila Harvoni je pokazala podobne rezultate.
English: Potential for other medicinal products to affect Harvoni Ledipasvir and sofosbuvir are substrates of drug transporter P-gp and BCRP while GS-331007 is not.
Slovenian: Možnost vpliva drugih zdravil na zdravilo Harvoni Ledipasvir in sofosbuvir sta substrata prenašalca P-gp in BCRP, GS-331007 pa ni.
English: Do not stop taking Harvoni
Slovenian: Ne prenehajte jemati zdravila Harvoni
English: b Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2;
Slovenian: b. Nemanjkajoči rezultati FibroTest so kartirani v rezultate Metavir glede na: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,59
English: Cirrhosis was defined by biopsy, Fibroscan (> 12.5 kPa) or FibroTest > 0.75 and an AST:platelet ratio index (APRI) of > 2.
Slovenian: Cirozo so opredelili z biopsijo, preiskavo Fibroscan (> 12,5 kPa) ali preiskavo FibroTest > 0,75 in indeksom razmerja AST:trombociti (APRI) > 2.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Harvoni, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Slovenian: Harvoni, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
English: Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Slovenian: Ena filmsko obložena tableta vsebuje 90 mg ledipasvirja in 400 mg sofosbuvirja.
English: Other medicines and Harvoni
Slovenian: Druga zdravila in zdravilo Harvoni
English: Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Slovenian: Ledipasvir je zaviralec HCV, ki deluje na beljakovino HCV NS5A, ki je bistvena za replikacijo RNA in sestavljanje virionov HCV.
English: This includes:
Slovenian: Ta zdravila vključujejo:
English: • feeling tired
Slovenian: • občutek utrujenosti Pogosti neželeni učinki
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Harvoni.
Slovenian: Kadar se presodi, da je sočasna uporaba amiodarona potrebna, se ob uvajanju zdravljenja z zdravilom Harvoni priporoča skrbno spremljanje bolnikov.
English: Table 19: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks
Slovenian: Preglednica 19: Stopnje odziva (SVR12) pri bolnikih z okužbo z genotipom 3 (ELECTRON-2) LDV/SOF+RBV 12 tednov
English: Patient
Slovenian: Bolnik
English: Genotype-specific activity
Slovenian: Aktivnost, specifična za genotip
English: Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Slovenian: Antacidi npr. aluminijev hidroksid ali magnezijev hidroksid; kalcijev karbonat
English: e 0/4 of these patients had cirrhosis.
Slovenian: e. 0 od teh 4 bolnikov ni imel ciroze.
English: 4.6 Fertility, pregnancy and lactation
Slovenian: 4.6 Plodnost, nosečnost in dojenje Ženske v rodni dobi/kontracepcija pri moških in ženskah
English: Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant
Slovenian: Ciroza stopnje B po Child-PughTurcotteu (CPT) pred presaditvijo
English: The potential risks and benefits associated with co-administration of Harvoni with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Slovenian: Upoštevati je treba možna tveganja in koristi, povezana s sočasno uporabo zdravila Harvoni s tableto s kombinacijo fiksnih odmerkov, ki vsebuje elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirat fumarat ali dizoproksiltenofoviratom fumaratom, dajanim v povezavi z okrepljenim zaviralcem proteaze HIV (npr. atazanavirjem ali darunavirjem), zlasti pri bolnikih, pri katerih je tveganje za ledvično disfunkcijo povečano.
English: This is so that:
Slovenian: Razlog za to je:
English: The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT class B and C).
Slovenian: Farmakokinetiko sofosbuvirja so proučili po 7-dnevnem odmerjanju 400 mg sofosbuvirja pri bolnikih, okuženih s HCV, z zmerno in hudo jetrno okvaro (stopnja B ali C po CPT).
English: In the pooled analysis of the Phase 3 studies, 16% of patients had baseline NS5A RAVs identified by population or deep sequencing irrespective of subtype.
Slovenian: V združeni analizi študij 3. faze je imelo 16 % bolnikov izhodiščne RAV NS5A, določene s karakterizacijo nukleotidnih sledi genoma ali karakterizacijo strukture genoma, ne glede na podtip.
English: Randomisation was stratified by the presence or absence of cirrhosis and HCV genotype (1a versus 1b).
Slovenian: Randomizacija je bila stratificirana glede na prisotnost ali odsotnost ciroze in genotip HCV (1a v primerjavi z 1b).
English: Afterwards, close monitoring and potential dose adjustment of tacrolimus may be required.
Slovenian: Kasneje bo morda potrebno natančno spremljanje in prilagoditev odmerka takrolimusa.
English: The clinical data to support the use of Harvoni in adults infected with HCV genotype 2 and 6 are limited (see section 5.1).
Slovenian: Klinični podatki, ki bi podprli uporabo zdravila Harvoni pri odraslih z okužbo s HCV genotipov 2 in 6, so omejeni (glejte poglavje 5.1).
English: • amiodarone used to treat irregular heartbeats;
Slovenian: • amiodaron, ki se uporablja za zdravljenje nerednega srčnega utripa,
English: Harvoni tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
Slovenian: Tablete zdravila Harvoni so dobavljene v plastenkah iz polietilena visoke gostote (HDPE) z za otroke varno zaporko iz polipropilena, s sušilnim sredstvom iz silikagela in poliestrsko vato, ki vsebujejo 28 filmsko obloženih tablet.
English: When co-administered with Harvoni, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 4.4).
Slovenian: Pri sočasni uporabi z zdravilom Harvoni je treba razmisliti o zmanjšanem odmerku statinov in skrbno spremljati neželene učinke statinov (glejte poglavje 4.4).
English: Demographics and baseline characteristics were balanced across treatment-naïve and treatment-experienced patients.
Slovenian: Demografske in izhodiščne značilnosti so bile med predhodno nezdravljenimi in predhodno zdravljenimi bolniki uravnotežene.
English: No significant effects on foetal development have been observed with ledipasvir or sofosbuvir in rats and rabbits.
Slovenian: Pomembnih učinkov na razvoj ploda z ledipasvirjem ali sofosbuvirjem pri podganah in kuncih niso opazili.
English: c Administered as Harvoni.
Slovenian: c. Uporabljeno kot zdravilo Harvoni.
English: Ribavirin Dose* 15 mg/kg/day 600 mg/day 800 mg/day 1000 mg/day
Slovenian: 15 mg/kg/dan 600 mg/dan 800 mg/dan 1.000 mg/dan
English: TOTAL (n = 440)
Slovenian: SKUPAJ (n = 440)
English: HCV/HIV co-infected adults - ION-4
Slovenian: Odrasli s sočasno okužbo HCV/HIV - ION 4
English: Age (years): median (range) Male gender
Slovenian: mediana (razpon) Moški spol