FrancophonIA/ELRC3.0 huggingface dataset:
English: An interim analysis was conducted on 61 patients who received sofosbuvir and ribavirin; the majority of patients had HCV genotype 1, 44 patients were CPT class A and 17 patients were CPT class B. Of these 61 patients, 44 patients underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA <LLOQ at the time of transplantation.
Croatian: Interim analiza bila je provedena na 61 bolesniku koji je primao sofosbuvir i ribavirin; većina bolesnika imala je HCV­genotip 1, 44 bolesnika imalo CPT stadij A, a 17 bolesnika imalo je CPT stadij B.
English: Overall No cirrhosis
Croatian: Ukupno Bez ciroze
English: FUSION was a randomised, double-blinded study that evaluated 12 or 16 weeks of treatment with sofosbuvir and ribavirin in patients who did not achieve SVR with prior interferon-based treatment (relapsers and nonresponders).
Croatian: Prethodno liječeni odrasli - FUSION (ispitivanje 108) FUSION je bilo randomizirano, dvostruko slijepo ispitivanje u kojem se ocjenjivalo 12 ili 16 tjedana liječenja sofosbuvirom i ribavirinom u bolesnika koji nisu postigli SVR uz prethodno liječenje temeljeno na interferonu (relaps ili bez odgovora).
English: Cirrhosis n = number of patients with SVR12 response; N = total number of patients per group.
Croatian: S cirozomc n = broj bolesnika s odgovorom SVR12; N = ukupni broj bolesnika u skupini.
English: Treatment-experienced co-infected with HIV (PHOTON-1)
Croatian: Prethodno liječeni bolesnici koji su istodobno zaraženi HIV­om (PHOTON­1)
English: Sofosbuvir ↓ Cmax 0.95c (0.68, 1.33) ↑ AUC 1.30c (1.00, 1.69) Cmin (NA)
Croatian: Sofosbuvir ↓ Cmax 0,95c (0,68; 1,33) ↑ AUC 1,30c (1,00; 1,69) Cmin (ND/NP)
English: SVR12 to SVR24 concordance
Croatian: Podudarnost između SVR12 i SVR24
English: Sovaldi + ribavirin a for 24 weeks
Croatian: Sovaldi + ribavirin a tijekom 24 tjedna
English: Study 4062 was an open-label study that evaluated a fixed dose combination of sofosbuvir and velpatasvir in 59 HCV-infected patients with ESRD requiring dialysis.
Croatian: Ispitivanje 4062 bilo je otvoreno ispitivanje u kojem je procijenjena fiksna kombinacija doza sofosbuvira i velpatasvira u 59 bolesnika zaraženih HCV­om s ESRD­om koji je zahtijevao dijalizu.
English: No clinically relevant pharmacokinetic differences due to gender or race have been identified for sofosbuvir and GS-331007.
Croatian: Nisu utvrđene nikakve klinički važne razlike u farmakokinetici sofosbuvira i GS­331007 zbog spola ili rase.
English: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
Croatian: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC) ↔ GS­331007 (TPV ili BOC)
English: Table 15: Response rates in study VALENCE
Croatian: Tablica 15: Stope odgovora u ispitivanju VALENCE Genotip 2
English: Sovaldi in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
Croatian: U bolesnika kojima je transplantirana jetra, Sovaldi se preporučuje u kombinaciji s ribavirinom tijekom 24 tjedna.
English: HCV/HIV co-infected adult patients - PHOTON-1 (study 123) Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 12 or 24 weeks of treatment with sofosbuvir and ribavirin in patients with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Croatian: Klinička djelotvornost i sigurnost u posebnim populacijama Odrasli bolesnici istodobno zaraženi HCV/HIV-om - PHOTON-1 (ispitivanje 123) Sofosbuvir je bio ispitan u otvorenom kliničkom ispitivanju u kojem se ocjenjivala sigurnost i djelotvornost 12 tjedana ili 24 tjedna liječenja sofosbuvirom i ribavirinom u bolesnika s kroničnim hepatitisom C uzrokovanim genotipom 1, 2 ili 3 i istodobnom infekcijom virusom HIV­1.
English: NA = not available/not applicable a. Mean ratio (90% CI) of co-administered drug pharmacokinetics with/without sofosbuvir and mean ratio of sofosbuvir and GS-331007 with/without co-administered drug.
Croatian: Srednja vrijednost omjera (90% CI) farmakokinetike istodobno primijenjenog lijeka sa/bez sofosbuvira i srednja vrijednost omjera sofosbuvira i GS­331007 sa/bez istodobno primijenjenog lijeka.
English: • rash, itchy skin
Croatian: ● osip, svrbež kože
English: (n = 327)
Croatian: 12 tjedana (n = 327)
English: Virologic response in evaluable patientsa a. Evaluable patients are defined as those who have reached the specified time point at the time of the interim analysis.
Croatian: Virološki odgovor u bolesnika koji su se mogli procijenitia a.
English: Co-administration of such medicinal products is not recommended with Sovaldi (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena takvih lijekova sa Sovaldijem (vidjeti dio 4.5).
English: ANALEPTICS Modafinil
Croatian: OPIOIDNI ANALGETICI
English: Table 19: Virologic response post-transplant in patients with HCV RNA <LLOQ at the time of liver transplantation
Croatian: Tablica 19: Virološki odgovor nakon transplantacije u bolesnika s HCV RNK < donje granice kvantifikacije u vrijeme transplantacije jetre 12. tjedan nakon transplantacije (pTVR)b
English: Table 12 presents the subgroup analysis by genotype for cirrhosis and interferon classification.
Croatian: Tablica 12 prikazuje analizu prisutnosti ciroze i klasifikacije prema interferonu u podskupinama prema genotipu.
English: No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly.
Croatian: Nije potrebna prilagodba doze norgestimata/ etinilestradiola kad se sofosbuvir i norgestimat/ etinilestradiol primjenjuju istodobno.
English: Common anaemia
Croatian: Anemija
English: Clinical studies in patients with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve adult patients - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 1, 4, 5 or 6 HCV infection.
Croatian: Klinička ispitivanja u bolesnika s kroničnim hepatitisom C uzrokovanim genotipovima 1, 4, 5 i 6 Odrasli bolesnici koji prethodno nisu bili liječeni - NEUTRINO (ispitivanje 110) NEUTRINO je bilo otvoreno ispitivanje na jednoj skupini u kojem se ocijenilo 12 tjedana liječenja sofosbuvirom u kombinaciji s peginterferonom alfa 2a i ribavirinom u bolesnika koji prethodno nisu bili liječeni, a koji su imali infekciju genotipovima 1, 4, 5 ili 6 HCV­a.
English: Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection
Croatian: Terapija bez interferona za infekciju HCV­om genotipa 1, 4, 5, i 6
English: The efficacy of sofosbuvir was evaluated in five Phase 3 studies in a total of 1,568 adult patients with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve patients with genotype 1, 4, 5 or 6 chronic hepatitis C in combination with peginterferon alfa 2a and ribavirin and the other four studies were conducted in patients with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve patients, one in interferon intolerant, ineligible or unwilling patients, one in patients previously treated with an interferon-based regimen, and one in all patients irrespective of prior treatment history or ability to receive treatment with interferon.
Croatian: Jedno je ispitivanje bilo provedeno u kombinaciji s peginterferonom alfa 2a i ribavirinom u bolesnika koji prethodno nisu bili liječeni i imali su kronični hepatitis C uzrokovan genotipovima 1, 4, 5 ili 6, dok su ostala četiri ispitivanja bila provedena u kombinaciji s ribavirinom u bolesnika s kroničnim hepatitisom C uzrokovanim genotipovima 2 ili 3 uključujući jedno u bolesnika koji prethodno nisu bili liječeni, jedno u bolesnika koji nisu podnosili interferon, nisu bili pogodni za liječenje interferonom ili nisu dali pristanak za liječenje interferonom, jedno u bolesnika prethodno liječenih režimom na bazi interferona i jedno u svih bolesnika bez obzira na prethodno liječenje ili sposobnost primanja liječenja interferonom.
English: Study 4063 was an open-label study that evaluated a fixed dose combination of sofosbuvir and ledipasvir in 95 patients with HCV-infection and ESRD requiring dialysis.
Croatian: Ispitivanje 4063 bilo je otvoreno ispitivanje u kojem je procijenjena fiksna kombinacija sofosbuvira i ledipasvira u 95 bolesnika s infekcijom HCV­om s ESRD­om koji je zahtijevao dijalizu.
English: Otherb a. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment.
Croatian: Nazivnik za relaps je broj bolesnika s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja terapije.
English: Patients with genotype 1, 4, 5 or 6 CHC
Croatian: Bolesnici s CHC­om uzrokovanim genotipom 1, 4, 5 ili 6
English: Cirrhotic
Croatian: Ciklosporin
English: Discontinuation of dosing in adults and adolescents If the other medicinal products used in combination with Sovaldi are permanently discontinued, Sovaldi should also be discontinued (see section 4.4).
Croatian: Ako se trajno prekine primjena drugih lijekova u kombinaciji sa Sovaldijem, potrebno je također prekinuti primjenu Sovaldija (vidjeti dio 4.4).
English: Table 16: SVR12 rates for selected subgroups by genotype in study VALENCE
Croatian: Tablica 16: Stope SVR12 za odabrane podskupine prema genotipu u ispitivanju VALENCE Genotip 2
English: • headache
Croatian: ● glavobolja
English: Cirrhosis No
Croatian: Ciroza Ne
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Croatian: Učestalost sljedećih nuspojava nije poznata (učestalost se ne može procijeniti iz dostupnih podataka): - široko rasprostranjen, težak osip kod kojeg se koža guli i koji može biti popraćen vrućicom,
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Sovaldi.
Croatian: Nakon što počnete uzimati lijek Sovaldi, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.
English: Co-administration with such medicinal products is not recommended with Sovaldi (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena takvih lijekova sa Sovaldijem (vidjeti dio 4.4).
English: Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
Croatian: ↑ Cmax 1,45 (1,10; 1,92) ↑ AUC 1,34 (1,12; 1,59) Cmin (ND/NP)
English: Common arthralgia, back pain, muscle spasms, myalgia back pain, muscle spasms
Croatian: Često artralgija, bol u leđima, mišićni grčevi, mialgija bol u leđima, mišićni grčevi
English: The safety profile of sofosbuvir and ribavirin in liver transplant adult recipients with chronic hepatitis C was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Croatian: Sigurnosni profil sofosbuvira i ribavirina u odraslih bolesnika s kroničnim hepatitisom C kojima je transplantirana jetra bio je sličan onome opaženom u bolesnika liječenih sofosbuvirom i ribavirinom u kliničkim ispitivanjima faze 3 (vidjeti dio 5.1).
English: • feeling tired and irritable
Croatian: ● umor i razdražljivost
English: Tell your doctor if you have kidney problems or if you are on kidney dialysis.
Croatian: Tegobe s bubrezima Obavijestite liječnika ako imate tegobe s bubrezima ili se liječite dijalizom bubrega.
English: Interferon intolerant, ineligible or unwilling (POSITRON)
Croatian: Bolesnici koji nisu podnosili interferon, nisu bili pogodni za liječenje interferonom ili nisu dali pristanak za liječenje interferonom (POSITRON)
English: Sofosbuvir ↓ Cmax 0.52 (0.43, 0.62) ↓ AUC 0.52 (0.46, 0.59) Cmin (NA)
Croatian: ↓ Cmax 0,52 (0,43; 0,62) ↓ AUC 0,52 (0,46; 0,59) Cmin (NA)
English: IMMUNOSUPPRESSANTS Ciclosporine (600 mg single dose)
Croatian: Ciklosporine (jedna doza od 600 mg)
English: Treatment-experienced 90% (37/41) Non-cirrhotic
Croatian: Bolesnici koji prethodno nisu bili liječeni 97% (31/32) Bez ciroze
English: Otherc a. The efficacy analysis includes 6 patients with recombinant genotype 2/1 HCV infection.
Croatian: Analiza djelotvornosti uključuje 6 bolesnika s infekcijom rekombinantnim genotipom 2/1 HCV­a.
English: HCV genotype 2
Croatian: genotip 2 HCV­a genotip 3 HCV­a
English: Table 23: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Croatian: Tablica 23: Ishodi prema terapijskom režimu i trajanju liječenja, usporedba ispitivanja za infekciju genotipom 4, 5 i 6 HCV­a
English: The safety profile of sofosbuvir and ribavirin in HCV infected adult patients prior to liver transplantation was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Croatian: Sigurnosni profil sofosbuvira i ribavirina kod odraslih bolesnika zaraženih HCV­om prije transplantacije jetre bio je sličan onome opaženom u bolesnika liječenih sofosbuvirom i ribavirinom u kliničkim ispitivanjima faze 3 (vidjeti dio 5.1).
English: Hepatic impairment
Croatian: Nesanica nesanica
English: AUC, Cmax, Cmina,b
Croatian: Srednja vrijednost omjera (90% interval pouzdanosti) za AUC, Cmax, Cmina,b
English: The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected adult patients was similar to that observed in mono-infected HCV patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Croatian: Sigurnosni profil sofosbuvira i ribavirina kod odraslih bolesnika istodobno zaraženih HCV/HIV­om bio je sličan onome opaženom kod bolesnika zaraženih samo HCV­om koji su bili liječeni sofosbuvirom i ribavirinom u kliničkim ispitivanjima faze 3 (vidjeti dio 5.1).
English: Patients with genotype 3 CHC
Croatian: Bolesnici s CHC­om uzrokovanim genotipom 3
English: Metabolism and nutrition disorders: Very common decreased appetite
Croatian: Poremećaji metabolizma i prehrane:
English: The SVR rates for the 8, 12, and 24 week ledipasvir/sofosbuvir treatment groups were 93% (42/45), 100% (31/31), and 79% (15/19), respectively.
Croatian: Stope SVR­a u skupinama koje su liječene ledipasvirom/sofosbuvirom 8, 12 odnosno 24 tjedna bile su 93% (42/45),
English: Table 14: SVR12 rates for selected subgroups by genotype in study FUSION
Croatian: Tablica 14: Stope SVR12 za odabrane podskupine prema genotipu u ispitivanju FUSION Genotip 2
English: Genotype Genotype 1
Croatian: Genotip 1
English: Table 16 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment.
Croatian: Tablica 16 prikazuje analizu prisutnosti ciroze i prethodne izloženosti liječenju HCV­a u podskupinama prema genotipu.
English: b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
Croatian: Potrebno je razmotriti mogućnost produljenja trajanja terapije na više od 12 tjedana do najviše 24 tjedna, osobito u podskupina s jednim ili više čimbenika koji se otprije povezuju s nižim stopama odgovora na terapiju na bazi interferona (npr. uznapredovala fibroza/ciroza, visoke početne koncentracije virusa, crna rasa, ne-CC genotip IL28B, prethodni izostanak odgovora na terapiju peginterferonom alfa i ribavirinom).
English: No dose adjustment of sofosbuvir or ciclosporin is required at initiation of co-administration.
Croatian: Nije potrebna prilagodba doze sofosbuvira ili ciklosporina na početku istodobne primjene.
English: Otherc a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
Croatian: Analiza djelotvornosti uključuje 3 bolesnika s infekcijom rekombinantnim genotipom 2/1 HCV­a.
English: SOF+PEG+RBV 12 weeks
Croatian: SOF+PEG+RBV 12 tjedana
English: Severe RI (eGFR <30 mL/min/1.7 3m2)
Croatian: Teško oštećenje bubrega (eGFR < 30 ml/min/ 1,73 m2)
English: Patients with genotype 2 CHC
Croatian: Bolesnici s CHC­om uzorkovanim genotipom 2
English: Patients also taking beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease may be at increased risk for symptomatic bradycardia with coadministration of amiodarone.
Croatian: Rizik od simptomatske bradikardije kod istodobne primjene amiodarona može biti povećan u bolesnika koji također uzimaju beta blokatore ili u onih s istodobno prisutnom osnovnom srčanom bolešću i/ili uznapredovalom bolešću jetre.
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Croatian: Potrebno je razmotriti liječenje tih bolesnika i mogućnost produljenja trajanja terapije sofosbuvirom, peginterferonom alfa i ribavirinom na više od 12 tjedana do najviše 24 tjedna, osobito u podskupina s jednim ili više čimbenika koji se otprije povezuju s nižim stopama odgovora na terapiju temeljenu na interferonu (uznapredovala fibroza/ciroza, visoke početne koncetracije virusa, crna rasa, ne­CC genotip IL28B).
English: Table 14 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment.
Croatian: Tablica 14 prikazuje analizu prisutnosti ciroze i odgovora na prethodno liječenje HCV­a u podskupinama prema genotipu.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir containing-regimes are used in combination with amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5).
Croatian: Slučajevi teške bradikardije i srčanog bloka uočeni su kada su se režimi koji sadrže sofosbuvir koristili u kombinaciji s amiodaronom i/ili drugim lijekovima koji snižavaju srčanu frekvenciju
English: SOF+RBV 24 weeks (n = 250)
Croatian: SOF+RBV 24 tjedna (n = 250)
English: SOF+RBV 24 weeks
Croatian: SOF+RBV 24 tjedna
English: Treatment-naïve (NEUTRINO)
Croatian: Bolesnici koji prethodno nisu bili liječenia (NEUTRINO)
English: Emtricitabine ↔ Cmax 0.97 (0.88, 1.07) ↔ AUC 0.99 (0.94, 1.05) ↔ Cmin 1.04 (0.98, 1.11)
Croatian: ↔ Cmax 0,97 (0,88; 1,07) ↔ AUC 0,99 (0,94; 1,05) ↔ Cmin 1,04 (0,98; 1,11)
English: Musculoskeletal and connective tissue disorders: Very common arthralgia, myalgia
Croatian: Vrlo često artralgija, mialgija
English: PEG+RBV 24 weeks (n = 176)
Croatian: PEG+RBV 24 tjedna (n = 176)
English: SOF+RBV 16 weeks
Croatian: SOF+RBV 16 tjedana
English: GS-331007 ↓ Cmax 0.73c (0.65, 0.83) ↔ AUC 1.04c (0.89, 1.22) Cmin (NA)
Croatian: GS­331007 ↓ Cmax 0,73c (0,65; 0,83) ↔ AUC 1,04c (0,89; 1,22) Cmin (ND/NP)
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (prior null response to peginterferon alfa and ribavirin therapy, advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Croatian: Potrebno je razmotriti mogućnost liječenja tih bolesnika i mogućnost produljenja trajanja terapije sofosbuvirom, peginterferonom alfa i ribavirinom na više od 12 tjedana do najviše 24 tjedna, osobito u podskupina s jednim ili više čimbenika koji se otprije povezuju s nižim stopama odgovora na terapiju temeljenu na interferonu (prethodni izostanak odgovora na terapiju peginterferonom alfa i ribavirinom, uznapredovala fibroza/ciroza, visoke početne koncentracije virusa, crna rasa, ne­CC genotip IL28B).
English: No dose adjustment of sofosbuvir or efavirenz is required when sofosbuvir and efavirenz are used concomitantly.
Croatian: Nije potrebna prilagodba doze sofosbuvira ili efavirenza kad se sofosbuvir i efavirenz primjenjuju istodobno.
English: Dose modification in adolescents Dose reduction of Sovaldi is not recommended.
Croatian: Ne preporučuje se smanjenje doze lijeka Sovaldi.
English: Treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection
Croatian: Prethodno liječeni bolesnici s infekcijom HCV­om genotipa 1, 4, 5 i 6
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf (400 mg twice daily)
Croatian: Raltegravirf (400 mg dvaput na dan)
English: Refer to the ribavirin prescribing information for guidance on dose modification or discontinuation.
Croatian: Pogledajte smjernice za prilagodbu doze ili prekid primjene u informacijama o propisivanju ribavirina.
English: No dose adjustment of sofosbuvir or methadone is required when sofosbuvir and methadone are used concomitantly.
Croatian: Nije potrebna prilagodba doze sofosbuvira ili metadona kad se sofosbuvir i metadon primjenjuju istodobno.
English: Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 24 weeks of treatment with sofosbuvir and ribavirin in liver transplant recipients with chronic hepatitis C. Eligible patients were ≥18 years old and had undergone liver transplantation 6 to 150 months prior to screening.
Croatian: Sofosbuvir je bio ispitan u otvorenom kliničkom ispitivanju u kojem se ocjenjivala sigurnost i djelotvornost liječenja sofosbuvirom i ribavirinom u trajanju od 24 tjedna u bolesnika s kroničnim hepatitisom C kojima je transplantirana jetra.
English: Darunavir ↔ Cmax 0.97 (0.94, 1.01) ↔ AUC 0.97 (0.94, 1.00) ↔ Cmin 0.86 (0.78, 0.96)
Croatian: ↔ Cmax 0,97 (0,94; 1,01) ↔ AUC 0,97 (0,94; 1,00) ↔ Cmin 0,86 (0,78; 0,96)
English: No dose adjustment of sofosbuvir or emtricitabine is required when sofosbuvir and emtricitabine are used concomitantly.
Croatian: Nije potrebna prilagodba doze sofosbuvira ili emtricitabina kad se sofosbuvir i emtricitabin primjenjuju istodobno.
English: Tenofovir ↑ Cmax 1.25 (1.08, 1.45) ↔ AUC 0.98 (0.91, 1.05) ↔ Cmin 0.99 (0.91, 1.07)
Croatian: ↑ Cmax 1,25 (1,08; 1,45) ↔ AUC 0,98 (0,91; 1,05) ↔ Cmin 0,99 (0,91; 1,07)
English: No dose adjustment of sofosbuvir or rilpivirine is required when sofosbuvir and rilpivirine are used concomitantly.
Croatian: Nije potrebna prilagodba doze sofosbuvira ili rilpivirina kad se sofosbuvir i rilpivirin primjenjuju istodobno.
English: Co-administration of Sovaldi with rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Croatian: Očekuje se da će istodobna primjena Sovaldija s rifapentinom smanjiti koncentraciju sofosbuvira i tako dovesti do smanjenog terapijskog učinka lijeka Sovaldi.
English: You can also report any side effects directly to the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: • palpitations
Croatian: ● omaglica
English: Raltegravir ↓ Cmax 0.57 (0.44, 0.75) ↓ AUC 0.73 (0.59, 0.91) ↔ Cmin 0.95 (0.81, 1.12)
Croatian: ↓ Cmax 0,57 (0,44; 0,75) ↓ AUC 0,73 (0,59; 0,91) ↔ Cmin 0,95 (0,81; 1,12)
English: PEG+RBV 24 weeks (n = 243)
Croatian: PEG+RBV 24 tjedna (n = 243)
English: Co-administration of Sovaldi with modafinil is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Croatian: Očekuje se da će istodobna primjena Sovaldija s modafinilom smanjiti koncentraciju sofosbuvira i tako dovesti do smanjenog terapijskog učinka Sovaldija.
English: S-methadone ↔ Cmax 0.95 (0.79, 1.13) ↔ AUC 0.95 (0.77, 1.17) ↔ Cmin 0.95 (0.74, 1.22)
Croatian: ↔ Cmax 0,95 (0,79; 1,13) ↔ AUC 0,95 (0,77; 1,17) ↔ Cmin 0,95 (0,74; 1,22)
English: NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
Croatian: Metadonf (terapija održavanja metadonom [30 do 130 mg na dan])