FrancophonIA/ELRC3.0 huggingface dataset:
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ sofosbuvir (400 mg once daily)
Slovenian: Z ritonavirjem okrepljeni darunavir (800 mg/ 100 mg enkrat na dan)/ sofosbuvir (400 mg enkrat na dan)
English: (listed in section 6 of this leaflet).
Slovenian: (glejte poglavje 4.2).
English: PEG-IFN+RBV 39% (43)
Slovenian: Belci Genotip 1a Predhodno zdravljenje HCV PEG-IFN+RBV 39 % (43)
English: Caution is warranted and therapeutic concentration monitoring of digoxin is recommended when co-administered with Harvoni.
Slovenian: priporoča se tudi spremljanje terapevtske koncentracije digoksina.
English: Table 4: Adverse drug reactions identified with Harvoni Frequency
Slovenian: Preglednica 4: Neželeni učinki zdravila, identificirani pri pri zdravljenju z zdravilom Harvoni
English: What Harvoni contains
Slovenian: Kaj vsebuje zdravilo Harvoni
English: LIST OF EXCIPIENTS Contains lactose and sunset yellow FCF aluminium lake (E110).
Slovenian: Vsebuje laktozo in barvilo sončno rumeno FCF (E110).
English: ION-1 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin in 865 treatment-naïve patients with genotype 1 CHC
Slovenian: ION-1 je bila randomizirana, odprta študija, ki je ocenila 12- in 24-tedensko zdravljenje z ledipasvirjem/sofosbuvirjem z ribavirinom ali brez njega pri 865 predhodno nezdravljenih bolnikih s
English: The NS5A substitution Y93C emerged in the HCV of 1 patient (genotype 4), while NS5A RAVs present at baseline were observed at the time of failure in all patients.
Slovenian: Substitucija Y93C v polimerazi NS5A se je pojavila pri HCV pri 1 bolniku (genotip 4),
English: Lansoprazole e
Slovenian: Harvoni Lansoprazole Rabeprazol e
English: Such patients may therefore be dependent on other drug classes for clearance of HCV infection.
Slovenian: Takšni bolniki bodo morda odvisni od drugih razredov zdravil za odpravljanje okužbe s HCV. Posledično je treba razmisliti o dolgotrajnejšem zdravljenju pri bolnikih z negotovimi možnostmi naknadnega ponovnega zdravljenja.
English: No dose adjustment of Harvoni or darunavir (ritonavir boosted) is required.
Slovenian: Odmerka zdravila Harvoni ali darunavirja (okrepljenega z ritonavirjem) ni treba prilagajati.
English: b. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Slovenian: b. Bolniki brez statusa ciroze so bili izključeni iz te analize podskupin.
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI INTEGRAZE Raltegravir (400 mg dvakrat na dan)/ ledipasvir (90 mg enkrat na dan)d
English: Marketing Authorisation Holder Gilead Sciences International Ltd. Cambridge
Slovenian: Imetnik dovoljenja za promet z zdravilom Gilead Sciences International Ltd. Cambridge
English: d. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Slovenian: d. Bolniki brez statusa ciroze so bili izključeni iz te analize podskupin.
English: BOTTLE AND CARTON LABELLING
Slovenian: OZNAČEVANJE NA NALEPKI PLASTENKE IN ŠKATLI
English: Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)
Slovenian: Raltegravir (400 mg dvakrat na dan)/ sofosbuvir (400 mg enkrat na dan)d
English: Table 6: Demographics and baseline characteristics in study ION-3 Patient disposition
Slovenian: Preglednica 6: Demografske in izhodiščne značilnosti za študijo ION-3
English: NS5A RAVs were seen at the time of relapse in 11/13 patients (for genotype 1a: Q30R alone [n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1]; for genotype 1b: Y93H [n = 3], Y93H/C [n = 1]).
Slovenian: odpornostjo povezane različice RAV NS5A so ob času relapsa opazili pri 11/13 bolnikih (za genotip 1a: samo Q30R [n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1], za genotip 1b: Y93H [n = 3], Y93H/C [n = 1]).
English: ↔ Cmin 0.94 (0.77, 1.14) S-methadone ↔ Cmax 0.95 (0.79, 1.13)
Slovenian: ↔ Cmin 0,94 (0,77; 1,14) S-metadon ↔ Cmax 0,95 (0,79; 1,13)
English: Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir +
Slovenian: Pri predhodno zdravljenih bolnikih je bilo predhodno zdravljenje s PEG-IFN + ribavirinom ± zaviralcem proteaze HCV ali sofosbuvirjem + ribavirinom ± PEG-IFN neuspešno.
English: Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Slovenian: Rifampicin (600 mg enkrat na dan)/ sofosbuvir (400 mg enkratni odmerek)d
English: Emtricitabine ↔ Cmax 1.02 (0.98, 1.06)
Slovenian: Emtricitabin ↔ Cmax 1,02 (0,98; 1,06)
English: Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in patients with decompensated disease (irrespective of liver transplantation status), 3/7 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir relapsed, as compared to 4/68 in those without any baseline RAVs or RAVs conferring ≤ 100-fold reduced susceptibility to ledipasvir.
Slovenian: Po 12-tedenskem zdravljenju z ledipasvirjem/sofosbuvirjem z ribavirinom pri bolnikih z dekompenzirano boleznijo (ne glede na presaditev jeter) je do relapsa prišlo pri 3/7 bolnikov z izhodiščnimi RAV NS5A, ki so doprinesle k > 100-kratni zmanjšani dovzetnosti za ledipasvir, v primerjavi s 4/68 bolnikov brez izhodiščnih RAV ali RAV, ki so doprinesle k ≤ 100-kratni spremembi dovzetnosti za ledipasvir.
English: The safety of Harvoni has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis.
Slovenian: Varnost zdravila Harvoni ni bila ocenjena pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerularne filtracije [eGFR-estimated glomerular filtration rate] < 30 ml/min/1,73 m2) ali pri bolnikih z boleznijo ledvic v končni fazi (ESRD-end stage renal disease), zaradi katere bolnik potrebuje hemodializo (glejte poglavje 5.2).
English: ↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
Slovenian: ↑ Cmin 1,36 (1,23; 1,49) Kobicistat ↔ Cmax 1,25 (1,18; 1,32)
English: virus.
Slovenian: odmerka.
English: Table 8: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF
Slovenian: Preglednica 8: Stopnje relapsov glede na izhodiščne značilnosti v študiji ION-3, populacija bolnikov z virološkim neuspehom*
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203.
Slovenian: Sofosbuvir se obširno presnovi v jetrih, kjer tvori v farmakološko aktivni nukleozidni analog trifosfat
English: Lamivudine ↔ Cmax 0.93 (0.87, 1.00)
Slovenian: Lamivudin ↔ Cmax 0,93 (0,87; 1,00)
English: Common side effects (may affect up to 1 in 10 people)
Slovenian: (pojavijo se lahko pri do 1 od 10 bolnikov)
English: Table 13 presents relapse rates with the 12-week regimens (with or without ribavirin) for selected subgroups (see also previous section “Effect of baseline HCV resistance-associated variants on treatment outcome”).
Slovenian: za izbrane podskupine (glejte tudi prejšnje poglavje "Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja").
English: Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
Slovenian: < 50 ml/min (glejte poglavje 5.2).
English: ION-4 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir without ribavirin in HCV treatment-naïve and treatment-experienced patients with genotype 1 or 4 CHC who were co-infected with HIV-1.
Slovenian: Odrasli s sočasno okužbo HCV/HIV - ION 4 ION-4 je bila odprta klinična študija, ki je ocenjevala varnost in učinkovitost 12-tedenskega zdravljenja z ledipasvirjem/sofosbuvirjem brez ribavirina pri predhodno nezdravljenih in zdravljenih bolnikih s HCV s CHC genotipa 1 ali 4, ki so imeli sočasno okužbo z virusom HIV-1.
English: SVR Outcome for patients without SVR On-treatment virologic failure a
Slovenian: SVR Izid za bolnike brez SVR Virološki neuspeh med zdravljenjem a
English: NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir
Slovenian: Navodilo za uporabo Harvoni 90 mg/400 mg filmsko obložene tablete ledipasvir/sofosbuvir
English: 0% (0/86)b
Slovenian: 99 % (85/86)c
English: Very common side effects (may affect more than 1 in 10 people)
Slovenian: Če jemljete zdravilo Harvoni, boste morda dobili enega ali več spodaj navedenih neželenih učinkov: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: ↔ Cmin 1.06 (0.97, 1.15) Rilpivirine ↔ Cmax 0.97 (0.88, 1.07)
Slovenian: ↔ Cmin 1,06 (0,97; 1,15) Rilpivirin ↔ Cmax 0,97 (0,88; 1,07)
English: No dose adjustment of Harvoni or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Slovenian: Odmerka zdravila Harvoni ali emtricitabina/ rilpivirina/ dizoproksiltenofovirat fumarata ni treba prilagajati.
English: Abacavir ↔ Cmax 0.92 (0.87, 0.97)
Slovenian: Abakavir ↔ Cmax 0,92 (0,87; 0,97)
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)d
Slovenian: Z ritonavirjem okrepljeni darunavir (800 mg/ 100 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)
English: ↔ GS-331007 (Increase in gastric pH)
Slovenian: ↔ GS-331007 (zaviranje P-gp)
English: Ciclosporin ↔ Cmax 1.06 (0.94, 1.18)
Slovenian: Ciklosporin ↔ Cmax 1,06 (0,94; 1,18)
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)
Slovenian: Rifampicin (600 mg enkrat na dan)/ ledipasvir (90 mg enkratni odmerek)
English: Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate (200 mg/ 25 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Slovenian: Emtricitabin/ rilpivirin/ dizoproksiltenofovirat fumarat (200 mg/ 25 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir (400 mg enkrat na dan)c, d
English: Relapse a
Slovenian: Relaps a
English: No dose adjustment of Harvoni or efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is required.
Slovenian: Odmerka zdravila Harvoni ali efavirenza/ emtricitabina/ dizoproksiltenofovirat fumarata ni treba prilagajati.
English: The following adverse drug reactions have been identified with Harvoni (Table 4).
Slovenian: Pri uporabi zdravila Harvoni so ugotovili naslednje neželene učinke zdravila (preglednica 4).
English: Outcome for patients without SVR On-treatment virologic failure Relapse b
Slovenian: Izid za bolnike brez SVR Virološki neuspeh med zdravljenjem Relapsb
English: When given with elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate, Harvoni is expected to increase the concentration of tenofovir.
Slovenian: Pri uporabi z elvitegravirjem/ kobicistatom/ emtricitabinom/ dizoproksiltenofovirat fumaratom se pričakuje, da bo zdravilo Harvoni povečalo koncentracijo tenofovirja.
English: Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in post-liver transplant patients with compensated liver disease (SOLAR-1), none (n = 8) of the patients with baseline NS5A RAVs conferring a ledipasvir fold-change of > 100 relapsed.
Slovenian: Po 12-tedenskem zdravljenju z ledipasvirjem/sofosbuvirjem z ribavirinom pri bolnikih po presaditvi jeter s kompenzirano jetrno boleznijo (SOLAR-1) niso pri nobenem (n = 8) od bolnikov z izhodiščnimi RAV NS5A, ki so doprinesle k > 100-kratni spremembi dovzetnosti za ledipasvir, opazili relapsa.
English: No target organs of toxicity were identified in rat and dog studies with ledipasvir at AUC exposures approximately 7 times the human exposure at the recommended clinical dose.
Slovenian: Ledipasvir V študijah ledipasvirja na podganah in psih z izpostavljenostjo AUC, ki je bila približno 7-krat večja od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, niso opredelili ciljnih organov za toksičnost.
English: Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)
Slovenian: Ciklosporin (600 mg enkratni odmerek)/ sofosbuvir (400 mg enkratni odmerek)
English: Harvoni contains sunset yellow FCF aluminium lake (E110)
Slovenian: Zdravilo Harvoni vsebuje barvilo sončno rumeno FCF (E110)
English: Table 10: Response rates in study ION-1 LDV/SOF
Slovenian: Preglednica 10: Stopnje odziva v študiji ION-1 LDV/SOF
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)
Slovenian: ↔ AUC 1,00 (0,87; 1,13) PERORALNI KONTRACEPTIVI Norgestimat/ etinilestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/ ledipasvir (90 mg enkrat na dan)
English: IL28CC genotype FibroTest-Determined Metavir score b
Slovenian: Rezultat Metavir, določen s testom FibroTest b
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
Slovenian: Takrolimus ↓ Cmax 0,73 (0,59; 0,90)
English: H2-receptor antagonists may be administered simultaneously with or staggered from Harvoni at a dose that does not exceed doses comparable to famotidine 40 mg twice daily.
Slovenian: Antagoniste receptorjev H2 se lahko uporablja sočasno z zdravilom Harvoni ali ločeno v odmerku,
English: Table 7: Response rates in study ION-3 LDV/SOF
Slovenian: Preglednica 7: Stopnje odziva v študiji ION-3 LDV/SOF
English: In vitro resistance selection and cross-resistance studies indicate ledipasvir targets NS5A as its mode of action.
Slovenian: da ledipasvir cilja NS5A kot njegov način delovanja.
English: Genotype 1b 0.004 Genotype 2a
Slovenian: Genotip 1a IL28CC genotip
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet 84 (3 plastenke po 28) filmsko obloženih tablet
English: Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)
Slovenian: Takrolimus (5 mg enkratni odmerek)/ sofosbuvir (400 mg enkratni odmerek)h
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Slovenian: Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju in
English: Table 12: Response rates in study ION-2 LDV/SOF
Slovenian: Preglednica 12: Stopnje odziva v študiji ION-2 LDV/SOF
English: Relapse b
Slovenian: Relapsb
English: If you forget to take Harvoni It is important not to miss a dose of this medicine.
Slovenian: Če ste pozabili vzeti zdravilo Harvoni
English: Prior HCV therapy
Slovenian: Bolniki s CHC genotipa 3
English: Outcome for patients without SVR On-treatment virologic failure 0/215 Relapsea
Slovenian: Izid za bolnike brez SVR Virološki neuspeh med zdravljenjem Relapsa
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
Slovenian: Elvitegravir/ kobicistat/emtricitabin/ dizoproksiltenofovirat fumarat (150 mg/ 150 mg/ 200 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir (400 mg enkrat na dan)
English: Post-transplant
Slovenian: Po presaditvi
English: In study ION-4, 13 HCV/HIV-1 co-infected patients with genotype 1, including 1 cirrhotic patient, who had failed a sofosbuvir + ribavirin regimen were enrolled; the SVR was 100% (13/13) after 12 weeks of treatment with ledipasvir/sofosbuvir.
Slovenian: 1 bolnikom s cirozo, pri katerih režim s sofobuvirjem + ribavirinom ni bil uspešen; po 12 tednih zdravljenja z ledipasvirjem/sofobuvirjem je bil SVR 100 % (13/13).
English: Pravastating
Slovenian: Dojenje
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
Slovenian: Omeprazol (20 mg enkrat na dan)/ ledipasvir (90 mg enkratni odmerek)c/ sofosbuvir (400 mg enkratni odmerek)c
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone with or without other drugs that lower heart rate.
Slovenian: Pri uporabi zdravila Harvoni s sočasno uporabo amiodarona, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
English: NS5A transient replicons
Slovenian: Stabilni replikoni prehodni replikoni NS5A mediana (razpon)
English: HCV protease inhibitor + PEG-IFN+RBV
Slovenian: PEG-IFN+RBV
English: No effect = 1.00. b. All interaction studies conducted in healthy volunteers.
Slovenian: Ni učinka = 1,00 b. Vse študije interakcij so opravili pri zdravih prostovoljcih c. Uporabljeno kot zdravilo Harvoni d. Območje 70-143 %, znotraj katerega ni farmakokinetičnih interakcij e. To so zdravila v razredu, kjer je bilo mogoče predvideti podobne interakcije.
English: Harvoni is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Slovenian: Zdravilo Harvoni je kontraindicirano z rifampicinom, ki je močan induktor P-gp v črevesju
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Slovenian: Z ritonavirjem okrepljeni darunavir (800 mg/ 100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirat fumarat (200 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)
English: Atazanavir boosted with ritonavir (300 mg/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)c/ sofosbuvir (400 mg once daily)c, d
Slovenian: Z ritonavirjem okrepljeni atazanavir (300 mg/ 100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirat fumarat (200 mg/ 300 mg enkrat na dan)/ ledipasvir (90 mg enkrat na dan)
English: Hepatic impairment
Slovenian: zelo pogosti glavobol
English: Stable replicons
Slovenian: Genotip replikonov
English: No dose adjustment of Harvoni is required for patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno ledvično okvaro odmerka zdravila Harvoni ni treba prilagajati.
English: No dose adjustment of Harvoni or ciclosporin is required.
Slovenian: Odmerka zdravila Harvoni ali ciklosporina ni treba prilagajati.
English: Tenofovir ↑ Cmax 1.64 (1.54, 1.74) ↑ AUC 1.50 (1.42, 1.59) ↑ Cmin 1.59 (1.49, 1.70)
Slovenian: Ledipasvir ↑ Cmax 1,63 (1,51; 1,75) ↑ AUC 1,78 (1,64; 1,94) ↑ Cmin 1,91 (1,76; 2,08)
English: ↑ Statins
Slovenian: Harvoni
English: IL28CC genotype FibroTest-Determined Metavir scoreb
Slovenian: Rezultat Metavir, določen s testom FibroTestb
English: In vitro data indicate that ledipasvir may be a weak inducer of metabolising enzymes such as CYP3A4, CYP2C and UGT1A1.
Slovenian: kot so CYP3A4, CYP2C in UGT1A1.
English: Other b
Slovenian: Ne a b b
English: Based on the population pharmacokinetic analysis in HCV-infected patients, geometric mean steady-state AUC0-24 for ledipasvir (n = 2,113), sofosbuvir (n = 1,542), and GS-331007 (n = 2,113) were 7,290, 1,320 and 12,000 ng•h/mL, respectively.
Slovenian: (n = 1.542) oz. GS-331007 (n = 2.113) kot sledi: 7.290, 1.320 oz. 12.000 ng•h/ml.
English: No dose adjustment of Harvoni or tacrolimus is required.
Slovenian: Odmerka zdravila Harvoni ali takrolimusa ni treba prilagajati.
English: As Harvoni contains ledipasvir and sofosbuvir, any interactions that have been identified with these active substances individually may occur with Harvoni.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Zdravilo Harvonivsebuje ledipasvir in sofosbuvir, zato se pri uporabi zdravila Harvonilahko pojavijo katere koli interakcije, ki so jih opazili pri uporabi teh posameznih zdravilnih učinkovin.
English: Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni.
Slovenian: Harvoni s tipranavirjem (okrepljenim z ritonavirjem) zmanjšalo koncentracijo ledipasvirja,
English: Elderly
Slovenian: Ranitidine
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600 mg/ 200 mg/ 300 mg/ once daily)/ ledipasvir (90 mg once daily)
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI REVERZNE TRANSKRIPTAZE Efavirenz/ emtricitabin/ dizoproksiltenofovirat fumarat (600 mg/ 200 mg/ 300 mg/ enkrat na dan)/ ledipasvir (90 mg enkrat na dan)c/ sofosbuvir (400 mg enkrat na dan)c, d
English: Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
Slovenian: Atazanavir ↔ Cmax 1,07 (0,99; 1,14)
English: NS
Slovenian: Z
English: Titanium dioxide
Slovenian: Zaviralci protonske črpalke
English: Emtricitabine ↔ Cmax 1.02 (0.96, 1.08) ↔ AUC 1.04 (1.00, 1.08) ↔ Cmin 1.03 (0.97, 1.10)
Slovenian: Ledipasvir ↔ Cmax 1,11 (0,99; 1,24) ↔ AUC 1,12 (1,00; 1,25) ↔ Cmin 1,17 (1,04; 1,31)
English: Patient population*
Slovenian: Dispozicija bolnika
English: However, it is not recommended that ribavirin be increased to the originally assigned dose (1,000 mg to 1,200 mg daily).
Slovenian: Prilagajanje odmerka ribavirina pri bolnikih, ki jemljejo 1.000-1.200 mg na dan
English: Genotype 1a a
Slovenian: Ravni HCV RNA ob izhodišču a
English: Ledipasvir
Slovenian: ↑ Lopinavir
English: No Yes a. One patient was excluded from the LDV/SOF 12-week treatment arm and one patient was excluded from the LDV/SOF+RBV 24-week treatment arm as both patients were infected with genotype 4 CHC.
Slovenian: Ne Da a. En bolnik iz skupine 12-tedenskega zdravljenja z LDV/SOF in en bolnik iz skupine 24-tedenskega zdravljenja z
English: ↔ Cmin 1.07 (0.89, 1.28)
Slovenian: ↔ Cmax 0,97 (0,83; 1,14)
English: Yes d
Slovenian: Ne d f
English: Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
Slovenian: ↔ Cmin 0,91 (0,83; 0,99) Emtricitabin ↔ Cmax 1,08 (0,97; 1,21)
English: Ethinyl estradiol ↔ Cmax 1.15 (0.97, 1.36)
Slovenian: ↑ Cmin 1,23 (1,00; 1,51) Etinilestradiol ↔ Cmax 1,15 (0,97; 1,36)
English: ↔ Cmin 1.12 (1.05, 1.20) Ledipasvir ↔ Cmax 1.10 (1.01, 1.19)
Slovenian: ↔ Cmin 1,08 (0,98; 1,20) Ritonavir ↔ Cmax 1,17 (1,01; 1,35)
English: Esomeprazolee
Slovenian: Okskarbazepin
English: • palpitations
Slovenian: • zasoplost
English: The safety of these vaccines should continue to be carefully monitored.
Slovenian: Varnost teh zdravil je treba še naprej skrbno spremljati.
English: On 09 July 2015 the European Commission therefore triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the EMA to assess these concerns.
Slovenian: Zato je 9. julija 2015 Evropska komisija na podlagi farmakovigilančnih podatkov sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 in zahtevala od agencije EMA, da oceni omenjene pomisleke.
English: The vast majority of POTS reports came from a centre in Denmark (Brinth et al, 2015)1.
Slovenian: Velika večina poročil o sindromu POTS izhaja iz centra na Danskem (Brinth idr., 2015)1.
English: POTS is a systemic syndrome which has been known for a long time under different names and is still poorly understood.
Slovenian: Sindrom POTS je sistemski sindrom, ki je pod različnimi imeni znan že dolgo časa in je še vedno slabo razumljen.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 20 of Regulation (EC) No 726/2004 for HPV vaccines.
Slovenian: • Odbor za oceno tveganja na področju farmakovigilance (PRAC) je upošteval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004 o cepivih proti virusu HPV;
English: In this respect, the CHMP commented that these comparisons should take into account likely increasing awareness of these syndromes to ensure appropriate interpretation of emerging data.
Slovenian: V zvezi s tem je odbor CHMP pripomnil, da bo treba pri teh primerjavah upoštevati verjetno naraščajočo prepoznavnost teh sindromov, s čimer se zagotovi ustrezna interpretacija dobljenih podatkov.
English: The benefits of HPV vaccines continue to outweigh their risks.
Slovenian: Koristi cepiv proti virusu HPV so še vedno večje od tveganj.