FrancophonIA/ELRC3.0 huggingface dataset:
English: As a precautionary measure, it is preferable to avoid the use of Sovaldi during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu Sovaldija tijekom trudnoće.
English: In patients that discontinued therapy at 24 weeks, according to protocol, the relapse rate was 11/15.
Croatian: U bolesnika koji su prekinuli terapiju nakon 24 tjedna, sukladno planu ispitivanja, stopa relapsa iznosila je 11/15.
English: When you take Sovaldi in combination with 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 amiodaronom (lijek koji se primjenjuje kod srčanih tegoba), možete imati jednu ili više niže navedenih nuspojava:
English: 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: Sovaldi se smije primjenjivati istodobno s drugim direktno djelujućim antiviroticima samo ako se, na temelju dostupnih podataka, korist smatra većom od rizika.
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.
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.
English: All patients receiving Sovaldi in combination with amiodarone with or without other medicinal products 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 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: Non-Black
Croatian: Crnci Ne­crnci
English: The exposure to GS-331007 was not altered in the presence of a high-fat meal.
Croatian: Izloženost GS­331007 nije bila promijenjena u prisutnosti obroka bogatog mastima.
English: Plasma HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Croatian: Vrijednosti HCV RNK u plazmi bile su mjerene tijekom kliničkih ispitivanja pomoću testa COBAS TaqMan HCV (verzija 2.0), koji se koristi sa sustavom High Pure System.
English: SVR12 was achieved in 100 % (18/18) of patients treated with ledipasvir/sofosbuvir.
Croatian: SVR12 je postignut u 100% (18/18) bolesnika liječenih ledipasvirom/sofosbuvirom.
English: Q2 2021
Croatian: drugo tromjesečje 2021. godine
English: Pharmacotherapeutic group: Antivirals for systemic use, direct-acting antiviral; ATC code: J05AP08
Croatian: Farmakoterapijska skupina: lijekovi za liječenje sustavnih virusnih infekcija, direktno djelujući antivirotik; ATK oznaka: J05AP08
English: Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Croatian: Učestalost se definira kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) ili vrlo rijetko (< 1/10 000).
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Sovaldi.
Croatian: U nekih bolesnika sa šećernom bolesti zabilježene su niske razine šećera u krvi (hipoglikemija) nakon početka liječenja lijekovima kao što je Sovaldi.
English: SVR12 rate % (n/N)
Croatian: Podskupina Stopa SVR12 % (n/N)
English: It is very important that you also read the leaflets for the other medicines that you will be taking with Sovaldi.
Croatian: Vrlo je važno da pročitate i upute o lijeku za druge lijekove koje ćete uzimati sa Sovaldijem.
English: Do not stop taking Sovaldi
Croatian: Nemojte prestati uzimati Sovaldi
English: Patient population* Treatment
Croatian: Populacija bolesnika* Liječenje
English: Table 2 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration and cardiac status.
Croatian: Tablica 2 nudi smjernice za prilagodbu doze i prekid primjene na temelju koncentracije hemoglobina i srčanog statusa bolesnika.
English: If any of the side effects get serious tell your doctor.
Croatian: Ako neka od nuspojava postane ozbiljna, obavijestite svog liječnika.
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 silika­gel kao sredstvo za sušenje koje se mora držati u bočici kao pomoć u zaštiti tableta.
English: EU/1/13/894/001 28 film-coated tablets EU/1/13/894/002 84 (3 bottles of 28) film-coated tablets
Croatian: 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: Carcinogenicity studies in mice and rats do not indicate any carcinogenicity potential of sofosbuvir administered at doses up to 600 mg/kg/day in mouse and 750 mg/kg/day in rat.
Croatian: Ispitivanja kancerogenosti u miševa i štakora ne pokazuju nikakav kancerogeni potencijal sofosbuvira primijenjenog u dozama do 600 mg/kg na dan u miša i 750 mg/kg na dan u štakora.
English: Genotype 4, 5 or 6 Cirrhosis
Croatian: Genotip 4, 5 ili 6 Ciroza
English: Placebo recipients are not included in the tables since none achieved SVR12.
Croatian: Bolesnici koji su primali placebo nisu uključeni u tablice, budući da nijedan nije postigao SVR12.
English: Common depression depression, anxiety, agitation
Croatian: Depresija depresija, anksioznost, agitacija
English: As liver function may change during treatment with Sovaldi, a close monitoring of International Normalised Ratio (INR) values is recommended.
Croatian: Budući da tijekom liječenja Sovaldi može doći do promjene u funkciji jetre, preporučuje se pomno praćenje vrijednosti međunarodnog normaliziranog omjera (INR).
English: Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to <18 years (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 i adolescenata u dobi od 12 do < 18 godina (vidjeti dijelove 4.2, 4.4 i 5.1).
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: In addition, S282R and L320F substitutions were detected on treatment by deep sequencing in a pre-transplant subject with a partial treatment response.
Croatian: Nadalje, S282R i L320F supstitucije bile su otkrivene detaljnim sekvenciranjem tijekom liječenja i prije transplantacije u ispitanika s djelomičnim terapijskim odgovorom.
English: What you need to know before you take Sovaldi Do not take Sovaldi
Croatian: Što morate znati prije nego počnete uzimati Sovaldi Nemojte uzimati Sovaldi
English: Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide.
Croatian: Film ovojnica: poli(vinilni alkohol), titanijev dioksid, makrogol 3350, talk, žuti željezov oksid.
English: Common alopecia, dry skin, pruritus alopecia, dry skin
Croatian: Često alopecija, suha koža, pruritus alopecija, suha koža
English: Sofosbuvir was administered at a dose of 400 mg once daily.
Croatian: Sofosbuvir je bio primjenjivan u dozi od 400 mg jedanput na dan.
English: In rabbit studies exposure to sofosbuvir was 9 times the expected clinical exposure.
Croatian: U ispitivanjima na kunićima izloženost sofosbuviru bila je 9 puta veća od očekivane kliničke izloženosti.
English: Outcome for patients without SVR12
Croatian: Ishod u bolesnika bez SVR12
English: • dry skin
Croatian: ● suha koža
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 oznake {Rok valjanosti}.
English: Pregnancy and concomitant use with ribavirin
Croatian: Trudnoća i istodobna primjena ribavirina
English: The duration of administration of Sovaldi in patients awaiting liver transplantation should be guided by an assessment of the potential benefits and risks for the individual patient (see section 5.1).
Croatian: Trajanje primjene Sovaldija u bolesnika koji čekaju transplantaciju jetre treba odrediti prema procjeni mogućih koristi i rizika kod pojedinog bolesnika (vidjeti dio 5.1).
English: All patients who achieved SVR12 achieved SVR24 and SVR48.
Croatian: 4. Svi bolesnici koji su postigli SVR12 postigli su i SVR24 i SVR48.
English: Overview of outcomes by therapeutic regimen and treatment duration, a comparison across studies The following tables (Table 20 to Table 23) 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 20 do tablice 23) 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: SVR12 rates were similarly high in patients with baseline IL28B C/C allele [94/95 (99%)] and non-C/C (C/T or T/T) allele [202/232 (87%)].
Croatian: Stope održanog virološkog odgovora (SVR12) bile su slično visoke u bolesnika s početnim IL28B C/C alelom (94/95 [99%]) i ne­C/C (C/T or T/T) alelom (202/232 [87%]).
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 SVR­a.
English: Pregnancy must be avoided due to the use of Sovaldi together with ribavirin.
Croatian: Trudnoća se mora izbjegavati kod primjene lijeka Sovaldi zajedno s ribavirinom.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sovaldi when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Croatian: Slučajevi su potencijalno opasni po život, stoga se u bolesnika koji primaju Sovaldi amiodaron smije koristiti samo u situacijama kada se drugi zamjenski antiaritmici ne podnose ili su kontraindicirani.
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: - Keep this leaflet.
Croatian: ­ Sačuvajte ovu uputu.
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: If the starting dose of ribavirin is not well-tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels (see section 5.1).
Croatian: Ako se početna doza ribavirina ne podnosi dobro, dozu treba sniziti kako je klinički indicirano na temelju razina hemoglobina (vidjeti dio 5.1).
English: If vomiting occurs more than 2 hours after dosing, no further dose is needed.
Croatian: Ako povraćanje nastupi nakon više od 2 sata od uzimanja doze, nije potrebno ponovno uzeti dozu.
English: Other effects that may be seen during treatment with sofosbuvir:
Croatian: Ostale nuspojave koje se mogu uočiti tijekom liječenja sofosbuvirom
English: Reduce ribavirin dose to 600 mg/day if:
Croatian: Sniziti dozu ribavirina na 600 mg/ dan ako:
English: Placebo 12 weeks (n = 71)
Croatian: Placebo 12 tjedana (n = 71)
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP­a.
English: • chest pain, feeling weak
Croatian: ● bol u prsnom košu, osjećaj slabosti
English: HCV ANITIVIRAL AGENTS: HCV PROTEASE INHIBITORS Boceprevir (BOC)
Croatian: HCV ANTIVIRUSNI LIJEKOVI: INHIBITORI PROTEAZE HCV­a Boceprevir (BOC)
English: The film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with “GSI” and “7977” on the other side.
Croatian: Filmom obložene tablete su žute tablete u obliku kapsule, s utisnutim “GSI” na jednoj strani i “7977” na drugoj strani.
English: No specific antidote is available for overdose with Sovaldi.
Croatian: Nije dostupan specifični antidot za predoziranje Sovaldijem.
English: The SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed sofosbuvir with velpatasvir treatment and relapsed.
Croatian: Stopa SVR­a bila je 95% (56/59); od tri bolesnika koja nisu postigla SVR12, u jednog je bolesnika koji je završio liječenje sofosbuvirom i velpatasvirom zabilježen relaps.
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Croatian: Silika­gel kao sredstvo za sušenje nalazi se u posebnoj vrećici ili spremniku i ne smije se progutati.
English: • and you notice 18 hours or more after the time you usually take Sovaldi, wait and take the next dose at your usual time.
Croatian: ● i to opazite nakon što je prošlo 18 sati ili više od vremena kad obično uzimate Sovaldi, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: In these assays, the in vitro antiviral activity of sofosbuvir against the less common genotypes 4, 5 and 6 was similar to that observed for genotypes 1, 2 and 3.
Croatian: U ovim testovima, antivirusno djelovanje sofosbuvira in vitro protiv manje čestih genotipova 4, 5 i 6 bilo je slično onome opaženom za genotipove 1, 2 i 3.
English: Sovaldi + ribavirin Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
Croatian: Sovaldi + ribavirin Samo za primjenu u bolesnika koji nisu pogodni ili ne podnose peginterferon alfa (vidjeti dio 4.4).
English: The study was designed as a direct comparison of sofosbuvir and ribavirin versus placebo for 12 weeks.
Croatian: Ispitivanje je bilo ustrojeno kao izravna usporedba sofosbuvira i ribavirina naspram placeba tijekom 12 tjedana.
English: HCV replicons with reduced susceptibility to sofosbuvir have been selected in cell culture for multiple genotypes including 1b, 2a, 2b, 3a, 4a, 5a and 6a.
Croatian: Replikoni HCV­a sa smanjenom osjetljivošću na sofosbuvir odabrani su u staničnoj kulturi za više genotipova uključujući 1b, 2a, 2b, 3a, 4a, 5a i 6a.
English: Treatment-experienced (FUSION)
Croatian: Prethodno liječeni bolesnici (FUSION)
English: GS-331007 is efficiently removed by haemodialysis with an extraction coefficient of approximately 53%.
Croatian: GS­331007 se učinkovito odstranjuje hemodijalizom uz koeficijent ekstrakcije od približno 53%.
English: Yellow, capsule-shaped, film-coated tablet of dimensions 20 mm x 9 mm, debossed on one side with “GSI” and “7977” on the other side.
Croatian: Žuta, filmom obložena tableta u obliku kapsule, veličine 20 mm x 9 mm, s utisnutim “GSI” na jednoj strani i “7977” na drugoj strani.
English: If you are sick (vomit) less than 2 hours after taking Sovaldi, take another tablet.
Croatian: Ako povratite u razdoblju kraćem od 2 sata nakon uzimanja Sovaldija, uzmite drugu tabletu.
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 HCV­a i ishoda liječenja.
English: Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults and adolescents from the age of 12 years up to the age of 18 years.
Croatian: Sovaldi sadrži djelatnu tvar sofosbuvir koji se daje za liječenje infekcije virusom hepatitisa C u odraslih i adolescenata u dobi od navršenih 12 godina do 18 godina.
English: Table 5: Interactions between Sovaldi and other medicinal products
Croatian: Tablica 5: Interakcije između Sovaldija i drugih lijekova Lijekovi prema terapijskim područjima
English: Therefore, Sovaldi should not be used during breast-feeding.
Croatian: Stoga se Sovaldi ne smije primjenjivati tijekom dojenja.
English: The parent sofosbuvir accounts for approximately 4% of drug-related material systemic exposure (see section 5.2).
Croatian: Na prekursor sofosbuvira otpada približno 4% sistemske izloženosti tvarima povezanima s lijekom (vidjeti dio 5.2).
English: GS-331007 is not an inhibitor of OAT1, OCT2, and MATE1.
Croatian: GS­331007 nije inhibitor OAT1, OCT2 i MATE1.
English: A 4-hour haemodialysis session removed 18% of the administered dose.
Croatian: Tijekom 4 sata hemodijalize uklonilo se 18% primijenjene doze.
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating Sovaldi.
Croatian: Ako se istodobna primjena amiodarona smatra neophodnom, preporučuje se da se bolesnike pažljivo prati na početku uzimanja Sovaldija.
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: GS­461203 (djelatni metabolit sofosbuvira) nije inhibitor ljudskih DNK­ i RNK­polimeraza niti je inhibitor mitohondrijske RNK­polimeraze.
English: Site-directed mutagenesis of the S282T substitution in replicons of 8 genotypes conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the replication viral capacity by 89% to 99% compared to the corresponding wild-type.
Croatian: Ciljana mutageneza u vidu supstitucije S282T u replikonima 8 genotipova dovela je do 2 do 18 puta smanjene osjetljivosti na sofosbuvir i smanjila je kapacitet umnažanja virusa za 89% do 99% u usporedbi s odgovarajućim divljim tipom.
English: Sofosbuvir was fully active against substitutions associated with resistance to other direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors, NS3 protease inhibitors and NS5A inhibitors.
Croatian: Sofosbuvir je bio potpuno djelatan protiv supstitucija povezanih s rezistencijom na druge direktno djelujuće antivirotike s različitim mehanizmima djelovanja, kao što su NS5B ne­nukleozidni inhibitori, NS3 inhibitori proteaze i NS5A inhibitori.
English: In that study, there were no untoward effects observed at this dose level, and adverse reactions were similar in frequency and severity to those reported in the placebo and sofosbuvir 400 mg treatment groups.
Croatian: U tom ispitivanju nije bilo nepovoljnih učinaka opaženih pri ovoj razini doze, a nuspojave su imale sličnu učestalost i težinu kao i one zabilježene u terapijskim skupinama koje su primale placebo i sofosbuvir u dozi od 400 mg.
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 GS­331007 nisu inhibitori P­gp i BCRP pa se stoga ne očekuje da će povisiti izloženost lijekovima koji su supstrati ovih prijenosnika.
English: Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Croatian: Liječenje lijekom Sovaldi treba započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s CHC­om.
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: The sofosbuvir-associated resistance substitution S282T was not detected in any of these patients by deep sequencing or population sequencing.
Croatian: Supstitucija S282T povezana s rezistencijom na sofosbuvir nije otkrivena ni u jednog od ovih bolesnika bilo detaljnim sekvenciranjem ili populacijskim sekvenciranjem.
English: Protein binding of GS-331007 was minimal in human plasma.
Croatian: Vezanje GS­331007 za proteine u ljudskoj plazmi bilo je minimalno.
English: Use with moderate P-gp inducers
Croatian: Primjena s umjerenim induktorima P­gp­a
English: The median ribavirin dose was 600 mg-800 mg daily at weeks 4-24.
Croatian: Medijan doze ribavirina iznosio je 600 mg­800 mg na dan od 4. do 24. tjedna.
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir .
Croatian: Istodobna primjena amiodarona bila je ograničena tijekom kliničkog razvoja sofosbuvira.
English: Other special population(s)
Croatian: Druga(e) posebna(e) populacija(e)
English: The highest documented dose of sofosbuvir was a single supratherapeutic dose of sofosbuvir 1,200 mg administered to 59 healthy subjects.
Croatian: Najviša zabilježena doza sofosbuvira bila je jednokratna supraterapijska doza sofosbuvira od 1200 mg primijenjena u 59 zdravih ispitanika.
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 silika­gela i poliesterskom vatom.
English: ≥2 g/dL decrease in haemoglobin during any 4 week treatment period
Croatian: Sniženje hemoglobina za ≥ 2 g/dl tijekom bilo kojeg 4­tjednog razdoblja liječenja
English: Close monitoring is recommended if this medicinal product is administered with Sovaldi (see sections 4.4 and 4.8).
Croatian: Preporučuje se pažljivo praćenje ako se ovaj lijek primjenjuje sa Sovaldijem (vidjeti dijelove 4.4 i 4.8).
English: When you take Sovaldi with ribavirin or both peginterferon alfa and ribavirin, you may get one or more of the side effects below:
Croatian: Kad uzmete Sovaldi s ribavirinom ili peginterferonom alfa i ribavirinom, možete dobiti jednu ili više sljedećih nuspojava:
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 GS­331007 koja pokazuje da se većina doze apsorbira u roku od 2 sata nakon primjene.
English: Post-baseline NS5B sequences were available for 225 of the 226 patients, with deep sequencing data (assay cutoff of 1%) from 221 of these patients.
Croatian: Sekvence NS5B nakon početka ispitivanja bile su dostupne za 225 od 226 bolesnika, s podacima detaljnog sekvenciranja (granična vrijednost testa od 1%) za 221 od tih bolesnika.
English: HCV/HBV (hepatitis B virus) co-infection
Croatian: Istodobna infekcija HCV/HBV (virus hepatitisa B)
English: • Carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).
Croatian: ● karbamazepin, fenobarbital i fenitoin (lijekovi koji se primjenjuju za liječenje epilepsije i sprječavanje napadaja).
English: In this context, no adverse drug reactions specific to sofosbuvir have been identified.
Croatian: U tom kontekstu nisu utvrđene nikakve nuspojave specifične za sofosbuvir.