FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical efficacy and safety in special populations
Croatian: Klinička djelotvornost i sigurnost u posebnim populacijama
English: Tell your doctor if you take any of the following medicines: • amiodarone, used to treat irregular heartbeats.
Croatian: Obavijestite svog liječnika ako uzimate neki od sljedećih lijekova: • amiodaron, koji se koristi za liječenje nepravilnih otkucaja srca.
English: Clinical studies of sofosbuvir included 65 subjects aged 65 and over.
Croatian: Klinička ispitivanja sofosbuvira uključila su 65 ispitanika u dobi od 65 i više godina.
English: Subjects in these studies had compensated liver disease including cirrhosis.
Croatian: Ispitanici u tim ispitivanjima imali su kompenziranu bolest jetre uključujući cirozu.
English: • Modafinil (a medicine to treat people with narcolepsy to help them stay awake).
Croatian: • modafinil (lijek koji se primjenjuje za liječenje osoba s narkolepsijom kako bi im pomogao da ostanu budni).
English: Available pharmacokinetic data in animals has shown excretion of metabolites in milk (for details see section 5.3).
Croatian: Dostupni farmakokinetički podaci u životinja pokazuju da se metaboliti izlučuju u mlijeku (za detalje vidjeti dio 5.3).
English: Non-Black
Croatian: Ne-crnci
English: Placebo recipients are not included in the tables since none achieved SVR12.
Croatian: Ispitanici koji su primali placebo nisu uključeni u tablice, budući da nijedan nije postigao SVR12.
English: What Sovaldi contains
Croatian: Što Sovaldi sadrži
English: • Confirm that your treatment has worked and you are free of the hepatitis C virus.
Croatian: • potvrditi da Vam liječenje djeluje i da više nemate virus hepatitisa C.
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir.
Croatian: Prisutnost 40% ljudskog seruma nije imala učinka na djelovanje sofosbuvira protiv HCV-a.
English: The predominant (>90%) metabolite, GS-331007, is inactive.
Croatian: Glavni (> 90%) metabolit, GS-331007, nije aktivan.
English: Talk to your doctor or pharmacist if you have severe kidney problems or if you are on kidney dialysis as the effects of Sovaldi on patients with severe kidney problems have not been fully tested.
Croatian: Obratite se svom liječniku ili ljekarniku ako imate teške tegobe s bubrezima ili ste na bubrežnoj dijalizi, jer učinci lijeka Sovaldi na bolesnike s teškim tegobama s bubrezima nisu potpuno ispitani.
English: Patients awaiting liver transplantation - Study 2025
Croatian: Bolesnici koji čekaju transplantaciju jetre - ispitivanje 2025
English: All subjects who achieved SVR12 achieved SVR24 and SVR48.
Croatian: 4. Svi ispitanici koji su postigli SVR12 postigli su i SVR24 i SVR48.
English: • severe headaches (migraine), memory loss, loss of concentration
Croatian: • jake glavobolje (migrena), gubitak pamćenja, gubitak koncentracije
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Sovaldi, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Croatian: Kako bi se procijenilo ponovno pojavljivanje hepatocelularnog karcinoma povezanog s primjenom Sovaldi, nositelj odobrenja mora provesti i dostaviti rezultate prospektivnog ispitivanja sigurnosti, koristeći podatake koji proizlaze iz kohorte dobro definirane skupine bolesnika, na temelju dogovorenog protokola.
English: • Sovaldi is commonly used together with ribavirin.
Croatian: • Sovaldi se obično primjenjuje zajedno s ribavirinom.
English: Posology The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2).
Croatian: Preporučena doza je jedna tableta od 400 mg, koja se uzima peroralno jedanput na dan s hranom (vidjeti dio 5.2).
English: Genotype 4, 5 or 6 97% (34/35) Cirrhosis
Croatian: Genotip 4, 5 ili 6 97% (34/35) Ciroza
English: Metabolism and nutrition disorders: Very common decreased appetite
Croatian: Poremećaji metabolizma i prehrane: Vrlo često smanjeni apetit
English: 11-1-0258b)
Croatian: (QUANTUMb i 11-1-0258b)
English: Sovaldi is always taken with other medicines (see section 1 above).
Croatian: Sovaldi se uvijek uzima s drugim lijekovima (pogledajte dio 1 gore).
English: INFORMATION IN BRAILLE Sovaldi [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Sovaldi [samo vanjsko pakiranje]
English: A 4-hour haemodialysis session removed approximately 18% of administered dose.
Croatian: Tijekom 4 sata hemodijalize uklonilo se približno 18% primijenjene doze.
English: Pharmacotherapeutic group: Direct-acting antiviral; ATC code: J05AX15
Croatian: Farmakoterapijska skupina: antivirusni lijek s izravnim djelovanjem; ATK oznaka: J05AX15 Mehanizam djelovanja
English: Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Croatian: Sovaldi je indiciran u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa C (CHC) u odraslih (vidjeti dijelove 4.2, 4.4 i 5.1).
English: The use of Sovaldi in children and adolescents has not yet been studied.
Croatian: Primjena lijeka Sovaldi u djece i adolescenata nije još ispitana.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza {Rok valjanosti}.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/894/001 28 film-coated tablets EU/1/13/894/002 84 (3 bottles of 28) film-coated tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/894/001 28 filmom obloženih tableta EU/1/13/894/002 84 (3 bočice s 28) filmom obloženih tableta
English: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
Croatian: Očekuje se: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
English: Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults of 18 years and older.
Croatian: Sovaldi sadrži djelatnu tvar sofosbuvir koji se daje za liječenje infekcije virusom hepatitisa C u odraslih u dobi od 18 godina i starijih.
English: Each bottle contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets.
Croatian: Jedna bočica sadrži silika-gel kao sredstvo za sušenje koje se mora držati u bočici kao pomoć u zaštiti tableta.
English: The exposure to GS-331007 was not altered in the presence of a high-fat meal.
Croatian: Izloženost GS-331007 nije bila promijenjena u prisutnosti obroka bogatog mastima.
English: • You or your partner must use an effective birth control method during treatment and afterwards.
Croatian: • Vi ili Vaš(a) partner(ica) morate primjenjivati učinkovitu metodu kontrole začeća tijekom i nakon liječenja.
English: • and you notice within 18 hours of the time you usually take Sovaldi, you must take the tablet as soon as possible.
Croatian: • i to opazite u roku od 18 sati od vremena kad obično uzimate Sovaldi, morate što prije uzeti tabletu.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with sofosbuvir in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka sofosbuvir u jednoj ili više podskupina pedijatrijske populacije u liječenju kroničnog hepatitisa C (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The outcomes should be interpreted with caution, as subject numbers are small and SVR rates may be impacted by the selection of patients.
Croatian: Ishode treba tumačiti s oprezom, zbog malog broja ispitanika i zato što odabir bolesnika može utjecati na stope SVR-a.
English: The S282T substitution reverted to wild-type over the next 8 weeks and was no longer detectable by deep sequencing at 12 weeks post-treatment.
Croatian: Supstitucija S282T vratila se na divlji tip tijekom sljedećih 8 tjedana i više se nije mogla otkriti detaljnim sekvenciranjem
English: Therefore, Sovaldi should not be used during breast-feeding.
Croatian: Stoga se Sovaldi ne bi trebao primjenjivati tijekom dojenja.
English: • low white blood cell count (neutropenia); the signs may include getting more infections than usual, including fevers and chills, or sore throat or mouth ulcers
Croatian: • smanjen broj bijelih krvnih stanica (neutropenija); znakovi mogu uključivati učestalije infekcije nego obično, uključujući vrućice i zimice ili upalu grla ili ranice u ustima
English: Subjects with genotype 2 or 3 HCV were enrolled in an approximately 1:3 ratio.
Croatian: Ispitanici s genotipom 2 ili 3 HCV-a bili su uključeni u omjeru od približno 1:3.
English: The proportions of subjects who were interferon intolerant, ineligible, or unwilling were 9%, 44%, and 47%, respectively.
Croatian: Udio ispitanika koji nisu podnosili, nisu bili pogodni ili nisu pristali na interferon iznosio je 9%, 44%
English: Exposure to GS-331007 in these studies was up to 30 times (mouse) and 15 times (rat) higher than the clinical exposure at 400 mg sofosbuvir.
Croatian: Izloženost GS-331007 u ovim ispitivanjima bila je do 30 puta (miš) i 15 puta (štakor) veća od kliničke izloženosti kod doze od 400 mg sofosbuvira.
English: Overview of outcomes by therapeutic regimen and treatment duration, a comparison across studies The following tables (Table 18 to Table 21) present data from Phase 2 and Phase 3 studies relevant to the dosing to help clinicians determine the best regimen for individual patients.
Croatian: Pregled ishoda liječenja prema terapijskom režimu i trajanju, usporedba ispitivanja Sljedeće tablice (od tablice 18 do tablice 21) prikazuju podatke iz ispitivanja faze 2 i faze 3 koji su važni za doziranje kako bi se pomoglo kliničarima da odrede najbolji režim za pojedinog bolesnika.
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Sovaldi in combination with another DAA.
Croatian: Zbog dugog poluvijeka amiodarona, potrebno je također provesti odgovarajuće nadziranje bolesnika koji su prekinuli uzimanje amiodarona unutar nekoliko posljednjih mjeseci, a započet će terapiju Sovaldijem u kombinaciji s drugim izravno djelujućim antivirotikom.
English: Psychiatric disorders: Very common insomnia insomnia
Croatian: Psihijatrijski poremećaji: Vrlo često nesanica nesanica
English: Sovaldi tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
Croatian: Sovaldi tablete isporučuju se u bočicama od polietilena visoke gustoće (HDPE), s polipropilenskim sigurnosnim zatvaračem za djecu, koje sadrže 28 filmom obloženih tableta sa sredstvom za sušenje od silika-gela i poliesterskom vatom.
English: No dose adjustment is warranted for elderly patients (see section 5.2).
Croatian: Nije potrebna prilagodba doze u starijih bolesnika (vidjeti dio 5.2).
English: The median ribavirin dose was 600 mg-800 mg daily at weeks 4-24.
Croatian: Medijan doze ribavirina iznosio je 600 mg-800 mg na dan od 4. do 24. tjedna.
English: • getting a cold (nasopharyngitis)
Croatian: • prehlada (nazofaringitis)
English: On-treatment virologic failure
Croatian: Virološki neuspjeh uz liječenje
English: Co-administration with other direct-acting antivirals against HCV Sovaldi should only be co-administered with other direct-acting antiviral medicinal products if the benefit is considered to outweigh the risks based upon available data.
Croatian: Istodobna primjena s drugim antivirusnim lijekovima s izravnim djelovanjem protiv HCV-a Sovaldi se smije primjenjivati istodobno s drugim antivirusnim lijekovima s izravnim djelovanjem samo ako se, na temelju dostupnih podataka, korist smatra većom od rizika.
English: Mannitol (E421)
Croatian: Jezgra tablete manitol (E421)
English: Post-baseline NS5B sequences were available for 225 of the 226 subjects, with deep sequencing data (assay cutoff of 1%) from 221 of these subjects.
Croatian: Sekvence NS5B nakon početka ispitivanja bile su dostupne za 225 od 226 ispitanika, s podacima detaljnog sekvenciranja (granična vrijednost testa od 1%) za 221 od tih ispitanika.
English: Common depression depression, anxiety, agitation
Croatian: Često depresija depresija, anksioznost, agitacija
English: • The active substance is sofosbuvir.
Croatian: • Djelatna tvar je sofosbuvir.
English: These recommendations are based on the absorption kinetics of sofosbuvir and GS-331007 suggesting that the majority of the dose is absorbed within 2 hours after dosing.
Croatian: Ove se preporuke temelje na kinetici apsorpcije sofosbuvira i GS-331007 koja pokazuje da se većina doze apsorbira u roku od 2 sata nakon primjene.
English: The sofosbuvir-associated resistance substitution S282T was not detected in any of these subjects by deep sequencing or population sequencing.
Croatian: Supstitucija S282T povezana s rezistencijom na sofosbuvir nije otkrivena ni u jednog od ovih ispitanika bilo detaljnim sekvenciranjem ili populacijskim sekvenciranjem.
English: Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
Croatian: Samo za primjenu u bolesnika koji nisu pogodni ili ne podnose peginterferon alfa (vidjeti dio 4.4).
English: In an analysis evaluating the effect of baseline polymorphisms on treatment outcome, no statistically significant association was observed between the presence of any HCV NS5B variant at baseline and treatment outcome.
Croatian: U analizi kojom se procjenjivao učinak početnih polimorfizama na ishod liječenja nije bila opažena statistički značajna povezanost između prisutnosti bilo koje početne varijante NS5B HCV-a i ishoda liječenja.
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol
Croatian: Norgestimat/etinil estradiol
English: Liver transplant recipients - Study 0126
Croatian: Bolesnici kojima je transplantirana jetra - ispitivanje 0126
English: Sofosbuvir and GS-331007 are not inhibitors of P-gp and BCRP and thus are not expected to increase exposures of medicinal products that are substrates of these transporters.
Croatian: Sofosbuvir i GS-331007 nisu inhibitori P-gp i BCRP pa se stoga ne očekuje da će povisiti izloženost lijekovima koji su supstrati ovih prijenosnika.
English: After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7.
Croatian: Nakon jedne doze od 400 mg [14C]-sofosbuvira u zdravih ispitanika, omjer 14C-radioaktivnosti u krvi u odnosu na plazmu bio je približno 0,7.
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b) Yellow iron oxide (E172)
Croatian: Film ovojnica poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol 3350 (E1521) talk (E553b) željezov oksid, žuti (E172)
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf
Croatian: HIV ANTIVIRUSNI LIJEKOVI: INHIBITORI INTEGRAZE Raltegravirf
English: GS-461203 (the active metabolite of sofosbuvir) is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Croatian: GS-461203 (djelatni metabolit sofosbuvira) nije inhibitor ljudskih DNK- i RNK-polimeraza niti je inhibitor mitohondrijske RNKpolimeraze.
English: Outcome for subjects without SVR12
Croatian: Ishod u ispitanika bez SVR12
English: (400 mg twice daily)
Croatian: (400 mg dvaput na dan)
English: Clinical studies in subjects with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231)
Croatian: Klinička ispitivanja u ispitanika s genotipovima 2 i 3 kroničnog hepatitisa C Odrasli koji prethodno nisu bili liječeni - FISSION (ispitivanje 1231)
English: When you take Sovaldi in combination with another medicine to treat hepatitis C virus infection (including daclatasvir, simeprevir and ledipasvir) and amiodarone (a medicine used for heart problems), you may get one or more of the side effects below:
Croatian: Kada uzimate Sovaldi u kombinaciji s drugim lijekom za liječenje infekcije virusom hepatitisa C (što uključuje daklatazvir, simeprevir i ledipasvir) i amiodaron (lijek koji se primjenjuje kod srčanih tegoba), možete imati jednu ili više niže navedenih nuspojava:
English: Cmin (NA)
Croatian: Cmin (ND/NP)
English: Table 3: Interactions between Sovaldi and other medicinal products Medicinal product by therapeutic areas
Croatian: Tablica 3: Interakcije između Sovaldija i drugih lijekova
English: The predominant inactive circulating metabolite GS-331007 that accounts for greater than 90% of drug-related material systemic exposure is formed through pathways sequential and parallel to formation of active metabolite.
Croatian: Glavni inaktivni cirkulirajući metabolit GS-331007 na koji otpada više od 90% sistemske izloženosti tvarima povezanima s lijekom stvara se slijednim i usporednim putevima nastanka djelatnog metabolita.
English: HCV infected subjects, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria received 400 mg sofosbuvir and 1,000-1,200 mg ribavirin daily for a maximum of 24 weeks, subsequently amended to 48 weeks, or until the time of liver transplantation, whichever occurred first.
Croatian: Ispitanici zaraženi HCV-om, bez obzira na genotip, s hepatocelularnim karcinomom (HCC) koji su zadovoljavali kriterije MILAN primali su 400 mg sofosbuvira i 1000-1200 mg ribavirina dnevno tijekom najviše 24 tjedna, naknadno produljeno na 48 tjedana, ili do trenutka transplantacije jetre, štogod je bilo prije.
English: All patients receiving Sovaldi and another DAA in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Croatian: Sve bolesnike koji primaju Sovaldi i drugi izravno djelujući antivirotik u kombinaciji s amiodaronom s ili bez drugih lijekova koji snižavaju srčanu frekvenciju potrebno je također upozoriti na simptome bradikardije i srčanog bloka te im je potrebno savjetovati da hitno potraže liječnički savjet ukoliko osjete iste.
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Croatian: Za djelovanje na određeni genotip virusa hepatitisa C (HCV), vidjeti dijelove 4.4 i 5.1.
English: Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
Croatian: AUC sofosbuvira i GS-331007 bili su gotovo proporcionalni dozi u rasponu doza od 200 mg do 400 mg.
English: 28 out of 40 (70%) subjects achieved SVR12: 22/33 (73%) with HCV genotype 1 infection, 6/6 (100%) with HCV genotype 3 infection, and 0/1 (0%) with HCV genotype 4 infection.
Croatian: Dvadeset i osam od 40 (70%) ispitanika postiglo je SVR12: 22/33 (73%) s infekcijom HCV-om genotipa 1, 6/6 (100%) s infekcijom HCV-om genotipa 3 i 0/1 (0%) s infekcijom HCV-om genotipa
English: Sofosbuvir is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) while GS-331007 is not.
Croatian: Sofosbuvir je supstrat prijenosnika lijekova P-gp i proteina rezistencije raka dojke (BCRP) dok GS-331007 to nije.
English: The dose linearity of sofosbuvir and its primary metabolite, GS-331007, was evaluated in fasted healthy subjects.
Croatian: Linearnost doze sofosbuvira i njegovog primarnog metabolita, GS-331007, bila je procijenjena u zdravih ispitanika natašte.
English: What you need to know before you take Sovaldi Do not take Sovaldi
Croatian: Što morate znati prije nego počnete uzimati Sovaldi
English: This subject harboured <1% HCV S282T at baseline and developed S282T (>99%) at 4 weeks post-treatment which resulted in a 13.5-fold change in sofosbuvir EC50 and reduced viral replication capacity.
Croatian: Taj je ispitanik na početku nosio < 1% S282T HCV-a i razvio S282T (> 99%) 4 tjedna nakon liječenja, što je promijenilo vrijednost EC50 sofosbuvira 13,5 puta i smanjilo kapacitet umnažanja virusa.
English: Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
Croatian: manitol, mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid, magnezijev stearat.
English: post-transplant (pTVR)b
Croatian: 12. tjedan nakon transplantacije (pTVR)b
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sovaldi and another DAA when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Croatian: Slučajevi su potencijalno opasni po život, stoga se amiodaron smije koristiti samo u bolesnika koji primaju Sovaldi i drugi izravno djelujući antivirotik u slučajevima kada se drugi zamjenski antiaritmici ne podnose ili su kontraindicirani.
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Croatian: Put metaboličke aktivacije uključuje sekvencionalnu hidrolizu karboksilnog estera koju kataliziraju ljudski katepsin A (CatA) ili karboksilesteraza 1 (CES1) i cijepanje fosforamidata histidinskim trijadnim proteinom 1 koji veže nukleotide (engl. histidine triad nucleotide-binding protein 1 - HINT1) za kojom slijedi fosforilacija putem biosinteze pirimidinskih nukleotida.
English: The highest documented dose of sofosbuvir was a single supratherapeutic dose of sofosbuvir 1,200 mg administered to 59 healthy subjects.
Croatian: 4.9 Predoziranje Najviša zabilježena doza sofosbuvira bila je jednokratna supraterapijska doza sofosbuvira od 1200 mg primijenjena u 59 zdravih ispitanika.
English: Concerning co-administration with other direct-acting antivirals against HCV, see section 4.4.
Croatian: Za istodobnu primjenu s drugim antivirusnim lijekovima s izravnim djelovanjem protiv HCV-a, vidjeti dio 4.4.
English: (600 mg single dose)
Croatian: (jedna doza od 600 mg)
English: Sovaldi is not recommended for administration as monotherapy and should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection.
Croatian: Općenito Sovaldi se ne preporučuje primjenjivati kao monoterapiju, nego ga treba propisivati u kombinaciji s drugim lijekovima za liječenje infekcije hepatitisom C.
English: 95% of patients received antiretroviral therapy at the time of enrolment.
Croatian: U vrijeme uključenja, 95% ispitanika primalo je antiretrovirusnu terapiju.
English: Treatment-experienced (LONESTAR-2b)
Croatian: (LONESTAR-2b)
English: Dose modification Dose reduction of Sovaldi is not recommended.
Croatian: Ne preporučuje se sniženje doze Sovaldija.
English: HCV ANITIVIRAL AGENTS: HCV PROTEASE INHIBITORS Boceprevir (BOC)
Croatian: HCV ANTIVIRUSNI LIJEKOVI: INHIBITORI PROTEAZE HCV-a Boceprevir (BOC)
English: In subjects with ESRD, relative to subjects with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis.
Croatian: U ispitanika s završnim stadijem bolesti bubrega, u odnosu na ispitanike s normalnom funkcijom bubrega, AUC0-inf sofosbuvira bio je 28% viši kad se doza sofosbuvira dala 1 sat prije hemodijalize u usporedbi sa 60% višim vrijednostima kad se doza sofosbuvira dala 1 sat nakon hemodijalize.
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30) Cmin (NA)
Croatian: Sofosbuvir ↑ Cmax 2,54 (1,87; 3,45) ↑ AUC 4,53 (3,26; 6,30) Cmin (ND/NP)
English: Haemoglobin in subjects with history of stable cardiac disease
Croatian: Hemoglobin u ispitanika sa stabilnom srčanom bolesti u anamnezi