FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro potential for ledipasvir/sofosbuvir to affect other medicinal products At concentrations achieved in the clinic, ledipasvir is not an inhibitor of hepatic transporters including the OATP 1B1 or 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug and toxic compound extrusion (MATE) 1 transporter, multidrug resistance protein (MRP) 2 or MRP4.
Croatian: uključujući OATP 1B1 ili 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, prijenosnika za izbacivanje mnogih lijekova i toksičnih spojeva (MATE) 1, proteina odgovornog za rezistenciju na mnoge lijekove (MRP) 2 ili MRP4.
English: d. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Croatian: d. Pacijenti bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
English: Emtricitabine ↔ Cmax 1.02 (0.98, 1.06)
Croatian: Emtricitabin ↔ Cmax 1,02 (0,98; 1,06)
English: Previously treated adults with or without cirrhosis - ION-2 (study 0109) - Genotype 1 ION-2 was a randomised, open-label study that evaluated 12 and 24 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin (randomised 1:1:1:1) in genotype 1 HCV-infected patients with or without cirrhosis who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor.
Croatian: ION-2 bilo je randomizirano, otvoreno ispitivanje kojim se procijenilo 12 i 24 tjedna liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega u pacijenata (randomiziranih u omjeru 1:1:1:1) s cirozom ili bez nje zaraženih genotipom 1 HCV-a u kojih je prethodna terapija režimom na temelju interferona bila neuspješna, uključujući režime koji su sadržavali inhibitor proteaze HCV-a.
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)
Croatian: Norgestimat/etinilestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ etinilestradiol 0,025 mg)/ ledipasvir (90 mg jedanput na dan)
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150 mg/ 150 mg/ 200 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
Croatian: Elvitegravir/ kobicistat/ emtricitabin/ tenofovirdizoproksilfumarat (150 mg/ 150 mg/ 200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)
English: c/ sofosbuvir (400 mg once daily)
Croatian: c/ sofosbuvir (400 mg jedanput na dan)
English: Lamivudine ↔ Cmax 0.93 (0.87, 1.00)
Croatian: Lamivudin ↔ Cmax 0,93 (0,87; 1,00)
English: Relapse a
Croatian: Relapsa Ostalob
English: ↔ Cmin 1.06 (0.97, 1.15) Rilpivirine ↔ Cmax 0.97 (0.88, 1.07)
Croatian: ↔ Cmin 1,06 (0,97; 1,15) Rilpivirin ↔ Cmax 0,97 (0,88; 1,07)
English: LIST OF EXCIPIENTS Contains lactose and sunset yellow FCF aluminium lake (E110).
Croatian: Sadrži laktozu i boju sunset yellow FCF aluminium lake (E110).
English: Harvoni is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3).
Croatian: Harvoni je kontraindiciran s karbamazepinom, fenobarbitalom i fenitoinom, jakim induktorima intestinalnog P-gp-a (vidjeti dio 4.3).
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ ledipasvir (90 mg once daily)d
Croatian: Darunavir pojačan ritonavirom (800 mg/ 100 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)d
English: Both sofosbuvir and ledipasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
Croatian: I sofosbuvir i ledipasvir su bili potpuno djelatni protiv supstitucija povezanih s rezistencijom na druge antivirusne lijekove izravnog djelovanja i različitim mehanizmom djelovanja,
English: Ciclosporin ↔ Cmax 1.06 (0.94, 1.18)
Croatian: Ciklosporin ↔ Cmax 1,06 (0,94; 1,18)
English: It may harm them,
Croatian: Pacijente koji primaju
English: b. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Croatian: Pacijenti bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
English: Relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively.
Croatian: U odnosu na pacijente s normalnom funkcijom bubrega (eGFR > 80 ml/min/1,73 m2), AUC0-inf sofosbuvira bila je 61 %, 107 % odnosno
English: Genotype 6e
Croatian: Genotip 6e b a.
English: Tacrolimus ↓ Cmax 0.73 (0.59, 0.90)
Croatian: Takrolimus ↓ Cmax 0,73 (0,59; 0,90)
English: The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe hepatic impairment (CPT class C).
Croatian: Farmakokinetika ledipasvira bila je ispitana u HCV-negativnih pacijenata s teškim oštećenjem jetre (CPT stadij C) nakon jedne doze od 90 mg ledipasvira.
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
Croatian: Emtricitabin/ rilpivirin/ tenofovirdizoproksilfumarat (200 mg/ 25 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)
English: Treatment of patients with prior exposure to HCV direct-acting antivirals 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).
Croatian: U većini slučajeva, u pacijenata u kojih je liječenje ledipasvirom/sofosbuvirom bilo neuspješno vidi se selekcija mutacija za rezistenciju na inhibitor NS5A koje znatno smanjuju osjetljivost na ledipasvir
English: Table 10: Response rates in study ION-1 LDV/SOF
Croatian: Tablica 10: Stope odgovora u ispitivanju ION-1 LDV/SOF
English: Table 7: Response rates in study ION-3 LDV/SOF
Croatian: Tablica 7: Stope odgovora u ispitivanju ION-3 LDV/SOF
English: Outcome for patients without SVR On-treatment virologic failure
Croatian: Ishod u pacijenata bez SVR
English: - Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks should be considered for previously treated patients with uncertain subsequent retreatment options (see section 4.4).
Croatian: U prethodno liječenih pacijenata u kojih daljnja mogućnost ponovnog liječenja nije sigurna treba razmotriti primjenu lijeka Harvoni s ribavirinom tijekom 12 tjedana ili lijeka Harvoni (bez ribavirina) tijekom 24 tjedna (vidjeti dio 4.4).
English: NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir
Croatian: Uputa o lijeku: Informacija za korisnika Harvoni 90 mg/400 mg filmom obložene tablete ledipasvir/sofosbuvir
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.
Croatian: Jedan je pacijent bio isključen iz terapijske skupine liječene 12 tjedana LDV/SOF-om i jedan je pacijent bio isključen iz terapijske skupine liječene 24 tjedna LDV/SOF+RBV jer su imali CHC uzrokovan genotipom 4. b. Nazivnik za relaps je broj pacijenata s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja terapije.
English: Co-administration of Harvoni with rifapentine is expected to decrease the concentration of ledipasvir and sofosbuvir, leading to reduced therapeutic effect of Harvoni.
Croatian: Harvoni s rifapentinom smanjiti koncentraciju ledipasvira i sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
English: No dose adjustment of Harvoni or ciclosporin is required.
Croatian: Nije potrebna prilagodba doze lijeka Harvoni ili ciklosporina.
English: Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)
Croatian: Takrolimus (jedna doza od 5 mg)/ sofosbuvir (jedna doza od 400 mg)h
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.
Croatian: NS5A supstitucija Y93C pojavila se u HCV-u kod 1 pacijenta
English: Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir +
Croatian: U pacijenata koji su prethodno bili liječeni, prethodno liječenje PEG-IFN + ribavirinom ± inhibitorom proteaze HCV-a ili sofosbuvirom + ribavirinom ± PEG-IFN bilo je neuspješno.
English: Genotype 1a a
Croatian: Genotip 1aa
English: Prior HCV therapy
Croatian: Prethodna terapija HCV-a
English: Table 4: Adverse drug reactions identified with Harvoni Frequency
Croatian: Tablica 4: Nuspojave utvrđene uz Harvoni
English: - Harvoni (without ribavirin) for 24 weeks may be considered in patients who are ineligible for or intolerant to ribavirin.
Croatian: U pacijenata koji nisu pogodni za liječenje ribavirinom ili ga ne podnose može se razmotriti primjena lijeka Harvoni (bez ribavirina) tijekom 24 tjedna.
English: No new adverse drug reactions were detected among patients with decompensated cirrhosis and/or who were post-liver transplant and who received ledipasvir/sofosbuvir with ribavirin.
Croatian: U pacijenata s dekompenziranom cirozom i/ili onih poslije transplantacije jetre i koji su primali ledipasvir/sofosbuvir s ribavirinom, nisu otkrivene nove nuspojave.
English: Recommended dose
Croatian: UPUTA O LIJEKU
English: Common side effects (may affect up to 1 in 10 people)
Croatian: (mogu se javiti u do 1 na 10 osoba) • osip
English: Harvoni is contraindicated with rifabutin, a potent intestinal P-gp inducer (see section 4.3).
Croatian: Harvoni je kontraindiciran s rifabutinom, jakim induktorom intestinalnog P-gp (vidjeti dio 4.3).
English: Elimination Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%).
Croatian: [14C]-radioaaktivnosti u stolici i mokraći iznosila je 87 %, s time da je najviše radioaktivne doze otkriveno u stolici (86 %).
English: No dose adjustment of Harvoni or tacrolimus is required.
Croatian: Nije potrebna prilagodba doze lijeka Harvoni ili takrolimusa.
English: F0-F1
Croatian: UGT1A1.
English: Change in CPT: 59% (79/133) and 34% (45/133) had an improvement or no change of CPT scores from baseline to post-treatment week 12, respectively; of the 39 patients who had CPT C cirrhosis at baseline, 56% (22/39) had CPT B cirrhosis at post-treatment week 12; of the 99 patients who had CPT B cirrhosis at baseline, 29% (27/92) had CPT A cirrhosis at post-treatment week 12.
Croatian: CPT rezultata od početka do 12. tjedna nakon liječenja; od 39 pacijenata koji su imali CPT C stadij ciroze na početku, 56 % (22/39) imalo je CPT B stadij ciroze u 12. tjednu nakon liječenja; od
English: Table 12: Response rates in study ION-2 LDV/SOF
Croatian: Tablica 12: Stope odgovora u ispitivanju ION-2 LDV/SOF
English: Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) < 50 mL/min (see section 5.2).
Croatian: < 50 ml/min (vidjeti dio 5.2).
English: IL28CC genotype FibroTest-Determined Metavir scoreb
Croatian: Metavir-rezultat određen FibroTestomb
English: Co-administration of Harvoni with oxcarbazepine is expected to decrease the concentration of ledipasvir and sofosbuvir leading to reduced therapeutic effect of Harvoni.
Croatian: Harvoni s okskarbazepinom smanjiti koncentraciju ledipasvira i sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)
Croatian: Rifampicin (600 mg jedanput na dan)/ ledipasvir (jedna doza od 90 mg)d
English: Harvoni is contraindicated with rifampicin, a potent intestinal P-gp inducer (see section 4.3).
Croatian: Harvoni je kontraindiciran s rifampicinom, jakim induktorom intestinalnog P-gp (vidjeti dio 4.3).
English: In genotype 3 infected patients experiencing virologic failure, development of NS5A RAVs (including enrichment of RAVs present at baseline) was typically not detected at the time of failure (n = 17).
Croatian: (uključujući obogaćenje RAV-ova prisutno na početku) obično nije bio otkriven u vrijeme virološkog neuspjeha (n =17).
English: ERADICATE was an open-label study to evaluate 12 weeks of treatment with ledipasvir/sofosbuvir in 50 patients with genotype 1 CHC co-infected with HIV.
Croatian: Odrasli istovremeno zaraženi HCV/HIV-om - ERADICATE ERADICATE je bilo otvoreno ispitivanje kojim se procijenilo 12 tjedana liječenja ledipasvirom/sofosbuvirom u 50 pacijenata s CHC-om uzrokovanim genotipom 1 i istovremenom
English: The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 5.
Croatian: Vrijednosti EC50 ledipasvira i sofosbuvira protiv replikona pune duljine ili kimeričkih replikona koji kodiraju sekvence NS5A i NS5B iz kliničkih izolata navedene su u tablici 5. Prisutnost 40 % ljudskog seruma nije imala učinka na anti-HCV djelovanje sofosbuvira, ali je smanjila anti-HCV djelovanje ledipasvira 12 puta protiv replikona genotipa 1a HCV-a.
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
Croatian: Darunavir pojačan ritonavirom (800 mg/ 100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)
English: Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)
Croatian: Ciklosporin (jedna doza od 600 mg)/ sofosbuvir (jedna doza od 400 mg)h
English: • The other ingredients are
Croatian: • Drugi sastojci su Jezgra tablete:
English: • fainting
Croatian: • umor
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)
Croatian: HIV ANTIVIRUSNI LIJEKOVI: INHIBITORI REVERZNE TRANSKRIPTAZE Efavirenz/ emtricitabin/ tenofovirdizoproksilfumarat (600 mg/ 200 mg/ 300 mg/ jedanput na dan)/ ledipasvir (90 mg jedanput na dan)c/ sofosbuvir (400 mg jedanput na dan)c, d
English: ANTICOAGULANTS Dabigatran etexilate
Croatian: OTPADNIH MATERIJALA KOJI POTJEČU
English: before taking this medicine.
Croatian: OD LIJEKA, AKO JE POTREBNO
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
Croatian: Atazanavir pojačan ritonavirom (300 mg/ 100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)
English: Genotype 6a
Croatian: Genotip 6a b b
English: Patients with cirrhosis
Croatian: Pacijenti s cirozom
English: If you forget to take Harvoni It is important not to miss a dose of this medicine.
Croatian: Važno je da ne propustite uzeti dozu ovog lijeka.
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).
Croatian: Kad se primjenjuju istovremeno s lijekom Harvoni, potrebno je razmotriti sniženu dozu statina i provoditi pažljivo praćenje zbog nuspojava statina
English: ↑ Pravastatin
Croatian: I DOHVATA
English: SVR rates for selected subgroups Patients with cirrhosis Previously treated patients with cirrhosis a. 8 patients with genotype 4 HCV infection were enrolled in the study with 8/8 achieving SVR12.
Croatian: U ispitivanje je bilo uključeno 8 pacijenata s infekcijom genotipom 4 HCV-a; 8/8 ih je postiglo SVR12. b. Nazivnik za relaps je broj pacijenata s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja terapije.
English: Emtricitabine ↔ Cmax 1.02 (0.96, 1.08) ↔ AUC 1.04 (1.00, 1.08) ↔ Cmin 1.03 (0.97, 1.10)
Croatian: Norelgestromin ↔ Cmax 1,02 (0,89; 1,16) ↔ AUC 1,03 (0,90; 1,18) ↔ Cmin 1,09 (0,91; 1,31)
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.
Croatian: Na temelju analize populacijske farmakokinetike u pacijenata zaraženih HCV-om, geometrijska srednja vrijednost AUC0-24 u stanju dinamičke ravnoteže za ledipasvir (n = 2113), sofosbuvir
English: SVR Outcome for patients without SVR On-treatment virologic failure a
Croatian: SVR Ishod u pacijenata bez SVR
English: Due to the limited size of studies, the impact of baseline NS5A RAVs on treatment outcome for patients with genotype 2, 3, 4, 5 or 6 CHC has not been fully evaluated.
Croatian: Zbog ograničene veličine ispitivanja, utjecaj početnih NS5A RAV-ova na ishod liječenja pacijenata s
English: Gilead Sciences Ltd. Tel: + 353 214 825999
Croatian: Gilead Sciences S.r.l. Tel: + 39 02 439201
English: Marketing Authorisation Holder Gilead Sciences International Ltd. Cambridge
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Gilead Sciences International Ltd.
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.
Croatian: + emtricitabin/tenofovirdizoproksilfumarata i lijeka Harvoni u vremenskom razmaku (od 12 sati) dala je slične rezultate.
English: IMMUNOSUPPRESSANTS Ciclosporing
Croatian: IMUNOSUPRESIVI
English: This data indicate that renal clearance is the major elimination pathway for GS-331007 with a large part actively secreted.
Croatian: GS-331007 s time da se veliki dio izlučuje aktivno.
English: Use with certain HIV antiretroviral regimens
Croatian: Pacijenti su primali stabilnu antiretrovirusnu terapiju protiv virusa HIV-1
English: Gilead Sciences S.r.l.
Croatian: Gilead Sciences Ltd.
English: Gilead Sciences International Ltd. Tel: + 44 (0) 20 7136 8820
Croatian: Gilead Sciences Poland Sp. z o.o. Tel: +48 22 262 8702
English: (listed in section 6 of this leaflet).
Croatian: (vidjeti dio 4.3).
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
Croatian: Odrasli s cirozom ili bez nje koji prethodno nisu bili liječeni - ION-1 (ispitivanje 0102) - genotip 1 Ispitivanje ION-1 bilo je randomizirano, otvoreno ispitivanje kojim se procijenilo 12 i 24 tjedna liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega u 865 pacijenata s CHC-om uzrokovanim genotipom 1, uključujući one s cirozom (randomizirani u omjeru 1:1:1:1), koji prethodno nisu bili liječeni.
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.
Croatian: NS5A RAV-ovima koji nose > 100 puta smanjenu osjetljivost na ledipasvir imalo je relaps, u usporedbi s 4/68 pacijenata bez ikakvih početnih RAV-ova ili RAV-ova koji nose ≤ 100 puta smanjenu osjetljivost na ledipasvir.
English: Randomisation was stratified by the presence or absence of cirrhosis and HCV genotype (1a versus 1b).
Croatian: Randomizacija je bila stratificirana prema prisutnosti ili odsutnosti ciroze i genotipu
English: Otherb
Croatian: Nuspojava
English: Ledipasvir ↑ Cmax 1.68 (1.54, 1.84)
Croatian: ↑ Cmin 1,47 (1,38; 1,57) Ledipasvir ↑ Cmax 1,68 (1,54; 1,84)
English: Interaction not studied Close monitoring of INR is recommended with all vitamin K antagonists.
Croatian: Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja Harvoni.
English: Ledipasvir ↔ Cmax 0.92 (0.85, 1.00) ↔ AUC 0.91 (0.84, 1.00) ↔ Cmin 0.89 (0.81, 0.98)
Croatian: R-metadon ↔ Cmax 0,99 (0,85; 1,16) ↔ AUC 1,01 (0,85; 1,21) ↔ Cmin 0,94 (0,77; 1,14)
English: Ledipasvir ↔ Cmax 1.11 (0.99, 1.24)
Croatian: Atazanavir ↔ Cmax 1,07 (0,99; 1,14)
English: GS-331007 ↔ Cmax 0.97 (0.83, 1.14) ↔ AUC 1.00 (0.87, 1.13)
Croatian: GS-331007 ↔ Cmax 0,97 (0,83; 1,14)
English: Co-administration of Harvoni with tipranavir (ritonavir boosted) is expected to decrease the concentration of ledipasvir, leading to reduced therapeutic effect of Harvoni.
Croatian: smanjiti koncentraciju ledipasvira i tako dovesti do smanjenog terapijskog učinka lijeka Harvoni.
English: Harvoni is contraindicated with St. John's wort, a potent intestinal P-gp inducer (see section 4.3).
Croatian: Harvoni je kontraindiciran s gospinom travom, jakim induktorom intestinalnog P-gp (vidjeti dio 4.3).
English: Cirrhosis
Croatian: Ciroza
English: American
Croatian: DJECE
English: When given with tenofovir disoproxil fumarate used in conjunction with atazanavir/ritonavir, Harvoni increased the concentration of tenofovir.
Croatian: Kad se daje s tenofovirdizoproksilfumaratom koji se primjenjivao zajedno s atazanavirom/ritonavirom,
English: Ethinyl estradiol ↔ Cmax 1.15 (0.97, 1.36)
Croatian: ↑ Cmin 1,23 (1,00; 1,51) Etinilestradiol ↔ Cmax 1,15 (0,97; 1,36)
English: a. One patient in the LDV/SOF 24-week treatment arms and one patient in the LDV/SOF+RBV 24-week treatment arm were prior treatment failures of a non-pegylated interferon based regimen.
Croatian: Prethodno liječenje režimom na temelju nepegiliranog interferona bilo je neuspješno u jednog pacijenta u terapijskoj skupini liječenoj 24 tjedna LDV/SOF-om i jednog pacijenta u skupini liječenoj 24 tjedna LDV/SOF+RBV-om.
English: Norgestrel ↔ Cmax 1.18 (0.99, 1.41) ↑ AUC 1.19 (0.98, 1.45) ↑ Cmin 1.23 (1.00, 1.51)
Croatian: ↔ Cmin 0,97 (0,86; 1,10) Ledipasvir ↑ Cmax 1,45 (1,34; 1,56)
English: The safety of these vaccines should continue to be carefully monitored.
Croatian: Sigurnost ovih cjepiva i dalje se treba pažljivo pratiti.
English: The vast majority of POTS reports came from a centre in Denmark (Brinth et al, 2015)1.
Croatian: Velika većina prijava SPOT-a dolazi iz centra u Danskoj (Brinth et al, 2015.)1.
English: The benefits of HPV vaccines continue to outweigh their risks.
Croatian: Koristi cjepiva protiv HPV-a i dalje nadmašuju njihove rizike.
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.
Croatian: Stoga je Europska komisija 9. srpnja 2015. pokrenula postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 na temelju podataka o farmakovigilanciji i zatražila od EMA-e da ocijeni ta pitanja.
English: More than 80 million girls and women worldwide have now received these vaccines, and in some European countries they have been given to 90% of the age group recommended for vaccination.
Croatian: Više od 80 milijuna djevojčica i žena diljem svijeta primilo je ova cjepiva; u nekim europskim zemljama njima je cijepljeno 90 % pripadnica dobne skupine za koju se preporučuje cijepljenje.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 20 of Regulation (EC) No 726/2004 for HPV vaccines.
Croatian: • je Odbor za procjenu rizika u području farmakovigilancije (PRAC) razmotrio postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 za cjepiva protiv HPV-a;
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.
Croatian: U tom je smislu CHMP napomenuo da se tim usporedbama treba uzeti u obzir vjerojatno rastuća svijest o tim sindromima kako bi se zajamčilo ispravno tumačenje novih podataka.