FrancophonIA/ELRC3.0 huggingface dataset:
English: In contrast, the rate of ALT elevations in subjects using other types of oestrogens as typically used in hormonal replacement therapy (i.e., oral and topical oestradiol and conjugated oestrogens) was similar to the rate observed in subjects who were not using oestrogen-containing products (approximately 1% in each group).
Slovenian: V nasprotju s tem so bila zvišanja ALT pri tistih, ki so uporabljale druge vrste estrogenov, kakršni se običajno uporabljajo pri hormonskem nadomestnem zdravljenju (tj. peroralni in lokalni estradiol in konjugirani estrogeni), podobna deležu, opaženem med neuporabnicami zdravil z estrogenom (približno 1 % v vsaki skupini).
English: Ombitasvir was approximately 99.9% bound to human plasma proteins.
Slovenian: Ombitasvir je bil približno 99,9 % vezan na beljakovine v človeški plazmi.
English: The long-term clinical impact of the emergence or persistence of virus containing Viekirax- and dasabuvir-resistance-associated substitutions on future treatment is unknown.
Slovenian: Dolgoročni klinični vpliv pojava oziroma trajnosti virusov s substitucijami, povezanimi z odpornostjo proti zdravilom Viekirax in dasabuvirju, na zdravljenje, v prihodnje ni znan.
English: Three interrupted Viekirax and dasabuvir for one to seven days, including one on ethinyloestradiol.
Slovenian: Tri osebe so jemanje zdravila Viekirax in dasabuvirja prekinile za obdobje od enega do sedmih dni; ena od njih je dobivala etinilestradiol.
English: Viekirax safety and efficacy have been established in combination with dasabuvir and/or ribavirin.
Slovenian: Varnost in učinkovitost zdravila Viekirax sta bili ugotovljeni v kombinaciji z dasabuvirjem in/ali ribavirinom.
English: Skin and subcutaneous tissue disorders Very common
Slovenian: Bolezni kože in podkožja Zelo pogosti srbenje
English: ↑ diltiazem, verapamil
Slovenian: Pričakovano: ↑ diltiazem, verapamil
English: Ritonavir is predominantly metabolised by CYP3A and to a lesser extent, by CYP2D6.
Slovenian: Ritonavir se pretežno presnovi s CYP3A in v manjši meri s CYP2D6.
English: Low dose ritonavir, which is part of the fixed dose combination Viekirax, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy.
Slovenian: Majhen odmerek ritonavirja, ki je del fiksne kombinacije odmerkov v zdravilu Viekirax, lahko doseže selekcijo za odpornost na PI pri bolnikih, sočasno okuženih s HIV in brez hkratnega protiretrovirusnega zdravljenja.
English: There was 1 relapse in the 12week arm and 1 on-treatment virologic failure in the 24-week arm.
Slovenian: Bil je 1primer recidiva v 12-tedenski skupini in 1 primer virusne neodzivnosti na zdravljenje v 24-tedenski skupini.
English: Nevirapine etravirine
Slovenian: nevirapin etravirin
English: In mice, an increased incidence of open eye lid was present in foetuses of dams administered ombitasvir; however, the relationship to treatment with ombitasvir is uncertain.
Slovenian: Pri miših so ugotovili večjo incidenco odprtih očesnih vek pri plodovih samic, ki so dobivale ombitasvir, vendar povezanost z zdravljenjem z ombitasvirjem ni gotova.
English: Ombitasvir, paritaprevir and ritonavir are highly bound to plasma proteins.
Slovenian: Ombitasvir, paritaprevir in ritonavir so v zelo veliki meri vezani na beljakovine v plazmi.
English: • clarithromycin, telithromycin
Slovenian: • klaritromicin, telitromicin
English: Co-administration of Viekirax with everolimus is not recommended because of a significant increase in everolimus exposures which cannot be properly dose adjusted with available dose strengths (see section 4.4).
Slovenian: Sočasna uporaba zdravila Viekirax z everolimusom ni priporočljiva zaradi izrazitega povečanja izpostavljenosti everolimusu, katerega odmerek ne more biti ustrezno prilagojen z jakostmi odmerkov, ki so na voljo (glejte poglavje 4.4).
English: In Phase 3 clinical trials, 1075 subjects (including 181 with compensated cirrhosis) with genotype 1 HCV infection received the recommended regimen (see section 4.2).
Slovenian: Kumulativna analiza učinkovitosti V kliničnih preskušanjih 3. faze je 1075 preiskovancev (vključno s 181 s kompenzirano cirozo), okuženih s HCV genotipa 1, prejelo priporočeno shemo (glejte poglavje 4.2).
English: Substitution L28V in HCV NS5A reduced the susceptibility to ombitasvir by 21-fold.
Slovenian: Substitucija L28V v genu NS5A HCV je zmanjšala občutljivost za ombitasvir za 21-krat.
English: Ombitasvir Ombitasvir is an inhibitor of HCV NS5A which is essential for viral replication.
Slovenian: Ombitasvir je zaviralec beljakovine NS5A HCV, ki je nujna za replikacijo virusov.
English: Examples of contraindicated enzyme inducers are provided in section 4.3.
Slovenian: Primeri kontraindiciranih induktorjev encimov so navedeni v poglavju 4.3.
English: • amiodarone, disopyramide, dronedarone, quinidine, ranolazine
Slovenian: • amiodaron, dizopiramid, dronedaron, kinidin, ranolazin
English: Viekirax with dasabuvir is expected to increase the exposure to rosuvastatin more than 3-fold.
Slovenian: Pričakovati je, da zdravilo Viekirax z dasabuvirjem poveča izpostavljenost rosuvastatinu za več kot 3-krat.
English: Ombitasvir and its major inactive human metabolites (M29, M36) were not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Slovenian: Ombitasvir in njegova glavna neaktivna presnovka pri človeku (M29, M36) niso bili genotoksični v skupini preizkusov in vitro ali in vivo, vključno s preizkusom mutagenosti pri bakterijah, preizkusom kromosomskih aberacij na človeških limfocitih iz periferne krvi in v mikrojedrnem preizkusu in vivo pri miših.
English: Co-administration of efavirenz (enzyme inducer) based regimens with paritaprevir /ritonavir + dasabuvir resulted in ALT elevations and therefore, early discontinuation of the study.
Slovenian: Sočasna uporaba shem na podlagi efavirenza (ki je induktor encima) in kombinacije paritaprevir/ritonavir + dasabuvir je povzročila zvišanje ALT in zaradi tega zgodnje prenehanje študije.
English: What Viekirax looks like and contents of the pack
Slovenian: Izgled zdravila Viekirax in vsebina pakiranja
English: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Viekirax is taken in combination with ribavirin, see section 4.6 and refer to the Summary of Product Characteristics for ribavirin for additional information.
Slovenian: Da bi se izognili nosečnosti pri bolnicah in partnericah bolnikov, kadar se zdravilo Viekirax jemlje v kombinaciji z ribavirinom, je potrebna skrajna previdnost, glejte poglavje 4.6 in za dodatne informacije povzetek glavnih značilnosti zdravila za ribavirin.
English: If statin treatment is required during the treatment period, a switch to dose reduced pravastatin or rosuvastatin is possible.
Slovenian: Če je med obdobjem zdravljenja potrebno zdravljenje s statinom, je treba preiti na zmanjšani odmerek pravastatina ali rosuvastatina, če je mogoče.
English: Viekirax tablets are pink, oblong film-coated tablets of dimmensions 18.8 mm x 10.0 mm, marked with ‘AV1'.
Slovenian: Tablete zdravila Viekirax so rožnate, podolgovate, filmsko obložene tablete velikosti 18,8 mm x 10,0 mm, z oznako "AV1".
English: Extra precautions are needed if Viekirax is taken together with ribavirin.
Slovenian: Posebna previdnost je potrebna, če se zdravilo Viekirax jemlje skupaj z ribavirinom.
English: NNRTIs other than rilpivirine (efavirenz, etravirine and nevirapine) are contraindicated (see section 4.3).
Slovenian: Drugi NNRTI, razen rilpivirina (efavirenz, etravirin in nevirapin), so kontraindicirani (glejte poglavje 4.3).
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Concerning genotypespecific virological and clinical activity, see section 5.1.
Slovenian: Za virusno in klinično aktivnost, specifično za genotip, glejte poglavje 5.1.
English: HCV ANTIVIRALS Sofosbuvir
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HCV sofosbuvir
English: Duration
Slovenian: Trajanje
English: For dosing recommendations with calcineurin inhibitors see section 4.5.
Slovenian: Za priporočila o odmerjanju z zaviralci kalcinevrina glejte poglavje 4.5.
English: HIV protease inhibitors other than atazanavir and darunavir (e.g., indinavir, saquinavir, tipranavir, lopinavir/ritonavir) are contraindicated (see section 4.3).
Slovenian: Drugi zaviralci proteaze HIV, razen atazanavirja in darunavirja (npr. indinavir, sakvinavir, tipranavir, lopinavir/ritonavir) so kontraindicirani (glejte poglavje 4.3).
English: • astemizole, terfenadine
Slovenian: • astemizol, terfenadin
English: ANTIFUNGALS Ketoconazole 400 mg once daily
Slovenian: ANTIMIKOTIKI ketokonazol 400 mg enkrat na dan
English: Patients should be informed that fatigue has been reported during treatment with Viekirax in combination with dasabuvir and ribavirin (see section 4.8).
Slovenian: Bolnikom je treba povedati, da je bila med zdravljenjem z zdravilom Viekirax v kombinaciji z dasabuvirjem in ribavirinom opisana utrujenost (glejte poglavje 4.8).
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, female subjects would have approximately 55% higher, 100% higher and 15% higher ombitasvir, paritaprevir and ritonavir exposures than male subjects.
Slovenian: Na osnovi analize populacijske farmakokinetike iz kliničnih študij 3. faze bi imele preiskovanke približno 55 % večjo izpostavljenost ombitasvirju, 100 % večjo izpostavljenost paritaprevirju in 15 % večjo izpostavljenost ritonavirju kot moški preiskovanci.
English: To maximise absorption, Viekirax should be taken with food without regard to fat or calorie content.
Slovenian: Da bi bila absorpcija čim večja, je treba zdravilo Viekirax vzeti s hrano, ne glede na vsebnost maščob in kalorij.
English: GASTROINTESTINAL PRODUCTS (PROPULSIVE) Cisapride
Slovenian: ZDRAVILA Z DELOVANJEM V PREBAVILIH (PROPULZIVI) cisaprid
English: Potent inhibitors of P-gp, BCRP, OATP1B1 and/or OATP1B3 have the potential to increase the exposure to paritaprevir.
Slovenian: Močni zaviralci P-gp, BCRP, OATP1B1 in/ali OATP1B3 lahko povečajo izpostavljenost paritaprevirju.
English: Coadministration with ethinyloestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Slovenian: Sočasna uporaba z etinilestradiolom lahko poveča tveganje za zvišanje ALT (glejte poglavji 4.3 in 4.4).
English: Viekirax with or without dasabuvir was also evaluated without ribavirin in 18 GT1a- and GT4-infected patients; no adverse events of anaemia were seen in these subjects.
Slovenian: Zdravilo Viekirax z ali brez dasabuvirja je bil ovrednoten tudi brez ribavirina pri 18 bolnikih, okuženih z GT1a in GT4; pri teh preiskovancih niso opazili nobenih neželenih učinkov anemije.
English: All treatment-emergent variants in NS5A remained detectable at post-treatment Week 48.
Slovenian: Vse med zdravljenjem nastale variante gena NS5A so ostale zaznavne 48. teden po zdravljenju.
English: Viekirax with or without dasabuvir was administered as multiple doses in all the drug interaction studies except the drug interaction studies with carbamazepine, gemfibrozil, ketoconazole, and sulfamethoxazole/trimethoprim..
Slovenian: Zdravilo Viekirax z dasabuvirjem ali brez njega so uporabljali v večkratnih odmerkih v vseh študijah medsebojnega delovanja zdravil, razen v študijah medsebojnega delovanja s karbamazepinom, gemfibrozilom, ketokonazolom in kombinacijo sulfametoksazol/trimetoprim.
English: Drug interactions need to be carefully taken into account in the setting of HIV co-infection (for details see section 4.5, Table 2).
Slovenian: Pri bolnikih, ki so sočasno okuženi s HIV, je treba skrbno upoštevati medsebojna delovanja zdravil (za podrobnosti glejte poglavje 4.5, preglednico 2):
English: It is not known whether the active substances in Viekirax (ombitasvir, paritaprevir and ritonavir) pass into breast milk.
Slovenian: Ni znano, ali učinkovine v zdravilu Viekirax (ombitasvir, paritaprevir in ritonavir) prehajajo v materino mleko.
English: − Tablet film-coating: poly(vinyl alcohol) (E 1203), macrogol (3350), talc (E 553b), titanium dioxide (E 171) and red iron oxide (E 172).
Slovenian: − Filmska obloga tablete: polivinilalkohol (E 1203), makrogol 3350, smukec (E 553b), titanov dioksid (E 171), rdeči železov oksid (E 172).
English: The combination of atazanavir and Viekirax + dasabuvir increase bilirubin levels, in particular when ribavirin is part of the hepatitis C regimen (see sections 4.4 and 4.8).
Slovenian: Kombinacija atazanavirja in zdravila Viekirax + dasabuvirja zviša ravni bilirubina, zlasti kadar je ribavirin del sheme zdravljenja okužbe z virusom hepatitisa C (glejte poglavji 4.4 in 4.8).
English: The effect on Cmax and AUC of DAAs and lopinavir was similar to that observed when lopinavir/ritonavir 400/100 mg twice daily was administered with Viekirax with or without dasabuvir.
Slovenian: Vpliv na Cmax in AUC DAA in lopinavirja je bil podoben, kot ko sta bila lopinavir/ritonavir 400 mg/100 mg dvakrat na dan uporabljena skupaj z zdravilom Viekirax, z dasabuvirjem ali brez njega.
English: No dose adjustment of gemfibrozil is necessary.
Slovenian: Prilagoditev odmerka gemfibrozila ni potrebna.
English: Although ALT elevations associated with Viekirax and dasabuvir have been asymptomatic, patients should be instructed to watch for early warning signs of liver inflammation, such as fatigue, weakness, lack of appetite, nausea and vomiting, as well as later signs such as jaundice and discoloured faeces, and to consult a doctor without delay if such symptoms occur.
Slovenian: Čeprav so bila z zdravilom Viekirax in dasabuvirjem povezana zvišanja ALT asimptomatska, je treba bolnikom naročiti, da morajo biti pozorni na zgodnje opozorilne znake vnetja jeter, npr. na utrujenost, šibkost, pomanjkanje apetita, navzeo in bruhanje, pa tudi na poznejše znake, npr. zlatenico, spremembo barve blata, in da se morajo v primeru pojava simptomov brez odlašanja posvetovati z zdravnikom.
English: Hydrocodone (as given in a fixed-dose hydrocodone/ paracetamol)
Slovenian: Hidrokodon (kot fiksni odmerek kombinacije hidrokodon/par acetamol)
English: • efavirenz, nevirapine, etravirine
Slovenian: • efavirenz, nevirapin
English: Unchanged ombitasvir was the predominant component observed in the milk of lactating rats, without effect on nursing pups.
Slovenian: Nespremenjeni ombitasvir je bil glavna snov v mleku doječih podgan, brez vpliva na dojene mladiče.
English: In the greater than 500 genotype 1a baseline samples in this analysis, the most frequently observed resistance-associated variants were M28V (7.4%) in NS5A and S556G (2.9%) in NS5B.
Slovenian: V več kot 500 izhodiščnih vzorcih genotipa 1a v tej analizi sta bili najpogosteje opaženi z odpornostjo povezani varianti M28V (7,4 %) v NS5A in S556G (2,9 %) v NS5B.
English: HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine2
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV: NENUKLEOZIDNI ZAVIRALCI REVERZNE TRANSKRIPTAZE rilpivirin2
English: ↔ dasabuvir sirolimus is used together with Viekirax + dasabuvir, administer sirolimus 0.2 mg twice a week (every 3 or 4 days on the same two days each week).
Slovenian: Če je sirolimus uporabljen skupaj z zdravilom Viekirax in dasabuvirjem, dajte sirolimus 0,2 mg dvakrat na teden (vsake 3 ali 4 dni na enaka dva dni vsak teden).
English: ↑ astemizole/terfenadine
Slovenian: ↑ astemizol/terfenadin
English: Atazanavir can be used in combination with Viekirax and dasabuvir, if administered at the same time.
Slovenian: Atazanavir se lahko uporablja v kombinaciji z zdravilom Viekirax in dasabuvirjem, če se dajejo ob istem času.
English: How long to take Viekirax for
Slovenian: Kako dolgo jemati zdravilo Viekirax
English: Concomitant use of Viekirax and glucocorticoids, particularly long-term use, should only be initiated if the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.5).
Slovenian: Sočasno uporabo zdravila Viekirax in glukokortikoidov, zlasti v primeru dolgoročne uporabe, se sme začeti le, če možna korist zdravljenja odtehta tveganja za sistemske učinke kortikosteroidov (glejte poglavje 4.5).
English: Table 20.
Slovenian: Preglednica 20.
English: Accumulation is minimal for ombitasvir and approximately 1.5- to 2-fold for ritonavir and paritaprevir.
Slovenian: Kopičenje ombitasvirja in dasabuvirja je minimalno, kopičenje ritonavirja in paritaprevirja pa približno 1,5- do 2-kratno.
English: Genotype 1a, with compensated cirrhosis
Slovenian: Genotip 1a, s kompenzirano cirozo
English: Purpose of the medicine alfuzosin for an enlarged prostate amiodarone, disopyramide, dronedarone used to correct irregular heartbeats astemizole, terfenadine for allergy symptoms.
Slovenian: Namen uporabe zdravila alfuzosin pri povečani prostati amiodaron, dizopiramid, dronedaron za uravnavanje nerednega srčnega utripa astemizol, terfenadin pri simptomih alergije.
English: Substitutions R155C, A156T/V, and D168H/V in HCV NS3 reduced susceptibility to paritaprevir by 40- to 323-fold.
Slovenian: Substitucije R155C, A156T/V in D168H/V v HCV NS3 so zmanjšale občutljivost za paritaprevir za 40- do 323-krat.
English: The pharmacokinetics of Viekirax in paediatric patients has not been established (see section 4.2).
Slovenian: Farmakokinetika zdravila Viekirax pri pediatričnih bolnikih ni ugotovljena (glejte poglavje 4.2).
English: Ombitasvir, paritaprevir and ritonavir should be administered with food.
Slovenian: Ombitasvir, paritaprevir in ritonavir je treba jemati s hrano.
English: Lopinavir/ritonavir 800/200 mg once daily (administered in the evening) was also administered with Viekirax with or without dasabuvir.
Slovenian: Lopinavir/ritonavir 800 mg/200 mg enkrat na dan (uporabljen zvečer) so uporabili tudi z zdravilom Viekirax, z dasabuvirjem ali brez njega.
English: Darunavir combined with Viekirax + dasabuvir is not recommended in patients with extensive PI resistance.
Slovenian: Darunavir v kombinaciji z zdravilom Viekirax in dasabuvirjem ni priporočljiv pri bolnikih z obsežno odpornostjo proti PI.
English: SVR12 for HCV Genotype 4-Infected Subjects with Compensated Cirrhosis Ombitasvir + Paritaprevir + Ritonavir with RBV 12 Weeks
Slovenian: SVR12 pri preiskovancih, okuženih z HCV genotipom 4, s kompenzirano cirozo Ombitasvir + Paritaprevir + Ritonavir z RBV 12 tednov
English: Ritonavir does not inhibit OAT1 and is not expected to inhibit OCT2, OAT3, MATE1 and MATE2K at clinically relevant concentrations.
Slovenian: Ritonavir ne zavira OAT1 in ni pričakovati, da bi v klinično pomembni koncentraciji zaviral OCT2, OAT3, MATE1 in MATE2K.
English: Clinical trial in patients receiving opioid substitution therapy
Slovenian: Klinična preskušanja pri prejemnikih opioidnega nadomestnega zdravljenja
English: Note: The following variants were selected in cell culture but were not treatment-emergent: NS3 variants A156T in genotype 1a, and R155Q and D168H in genotype 1b; NS5A variants Y93C/H in genotype 1a, and L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
Slovenian: Opomba: Naslednje variante so bile selekcionirane v celični kulturi, vendar niso nastale med zdravljenjem: varianta gena NS3 A156T v genotipu 1a ter R155Q v genotipu 1b in D168H; varianta gena NS5A Y93C/H v genotipu 1a in L31F/V ali Y93H v kombinaciji z L28M, L31F/V ali P58S v genotipu 1b; in varianta gena NS5B Y448H v genotipu 1a in M414T in Y448H v genotipu 1b.
English: If a patient is already taking medicinal product(s) or initiating a medicinal product while receiving Viekirax with or without dasabuvir for which potential for drug interaction is expected, dose adjustment of the concomitant medicinal product(s) or appropriate clinical monitoring should be considered (Table 2).
Slovenian: Če bolnik že jemlje zdravilo/zdravila ali med zdravljenjem z zdravilom Viekirax (z dasabuvirjem ali brez njega) začne jemati kakšno zdravilo, za katero obstaja možnost medsebojnega delovanja, je treba razmisliti o prilagoditvi odmerka sočasno uporabljanega zdravila/zdravil ali ustreznem kliničnem spremljanju (preglednica 2).
English: Available pharmacokinetic data in animals have shown excretion of active substance and metabolite in milk (see section 5.3).
Slovenian: Farmakokinetični podatki, ki so na voljo za živali, so pokazali izločanje učinkovine in presnovka v mleko (glejte poglavje 5.3).
English: Mechanism: Effect on ciclosporin is due to
Slovenian: Mehanizem: Vpliv na ciklosporin je posledica zavrtja
English: The changes in ombitasvir, paritaprevir, and ritonavir exposures in subjects with mild, moderate and severe renal impairment are not considered to be clinically significant.
Slovenian: Okvara ledvic Spremembe izpostavljenosti ombitasvirju, paritaprevirju in ritonavirju pri osebah z blago, zmerno in hudo okvaro ledvic ne veljajo za klinično pomembne.
English: In HCV-infected subjects, in comparison to those without cirrhosis, paritaprevir AUC increased to 2.2- to 2.4-fold for those with compensated cirrhosis (Child-Pugh A) and 3- to 4-fold for those with Child-Pugh B cirrhosis.
Slovenian: Pri preiskovancih, okuženih z virusom hepatitisa C, se je v primerjavi s preiskovanci brez ciroze AUC paritaprevirja povečal 2,2- do 2,4-krat pri tistih s kompenzirano cirozo (Child-Pugh A) in 3- do 4-krat pri tistih z Child-Pugh B cirozo.
English: Norethindrone (progestin only pill) 0.35 mg once daily
Slovenian: ↓ dasabuvir noretindron (tablete, ki vsebujejo samo progestin) 0,35 mg enkrat na dan
English: GLUCOCORTICOIDS (INHALED) Fluticasone
Slovenian: GLUKOKORTIKOIDI (ZA INHALIRANJE) flutikazon
English: The activity of ombitasvir was reduced by 661-, 77-, 284- and 142-fold against the genotype 1b substitutions L28T, Y93H, R30Q in combination with Y93H, and L31M in combination with Y93H, respectively.
Slovenian: Aktivnost ombitasvirja se je zmanjšala za 661-, 77-, 284- oziroma 142-krat proti substitucijam genotipa 1b L28T, Y93H, R30Q v kombinaciji z Y93H oziroma L31M v kombinaciji z Y93H.
English: • oral midazolam, triazolam
Slovenian: • peroralni midazolam, triazolam
English: Simvastatin, lovastatin and atorvastatin are contraindicated (see sections 4.3 and 4.5).
Slovenian: Simvastatin, lovastatin in atorvastatin so kontraindicirani (glejte poglavji 4.3 in 4.5).
English: ↑ losartan ↑ candesartan
Slovenian: ↑ valsartan ↑ losartan ↑ kandesartan
English: Recommended co-administered medicinal product(s) and treatment duration for Viekirax by patient population
Slovenian: Preglednica 1: Priporočena sočasna zdravila in trajanje zdravljenja z zdravilom Viekirax glede na populacijo bolnikov
English: Table 17 shows the primary efficacy analysis of SVR12 performed on subjects with HCV GT1/HIV-1 coinfection that received recommended regimen in Part 2 of the TURQUOISE-I study.
Slovenian: Preglednica 17 prikazuje analizo primarne učinkovitosti SVR12 pri preiskovancih, sočasno okuženih s HCV GT1/HIV-1, ki so prejemali priporočen režim zdravljenja v delu 2 študije TURQUOISE-I.
English: Examples of other CYP3A4 substrates which may require dose adjustment and/or clinical monitoring include calcium channel blockers (e.g. nifedipine), and trazodone.
Slovenian: Med primeri drugih substratov CYP3A4, pri katerih je lahko potrebna prilagoditev odmerka, klinično spremljanje ali oboje, so zaviralci kalcijevih kanalčkov (npr. nifedipin) in trazodon.
English: Coadministration with enzyme inducers may increase the risk of adverse reactions and ALT elevations (see Table 2).
Slovenian: Sočasna uporaba z induktorji encimov lahko poveča tveganje za neželene učinke in zvišanje ALT (glejte preglednico 2).
English: Titanium dioxide (E 171) Iron oxide red (E 172)
Slovenian: rdeči železov oksid (E 172)