FrancophonIA/ELRC3.0 huggingface dataset:
English: As liver function may change during treatment with Sovaldi, a close monitoring of International Normalised Ratio (INR) values is recommended.
Slovenian: Ker se delovanje jeter v času zdravljenja z zdravilom Sovaldi lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR).
English: Treatment duration was fixed in each study and was not guided by patients' HCV RNA levels (no response guided algorithm).
Slovenian: Trajanje zdravljenja je bilo določeno za vsako študijo in se ni usmerjalo glede na ravni RNA HCV bolnikov (brez algoritma, vodenega z odzivi).
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Slovenian: Drugi učinki, ki se lahko pojavijo med zdravljenjem s sofosbuvirjem: Pogostnost naslednjih neželenih učinkov ni znana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: Women of childbearing potential / contraception in males and females
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah
English: This patient achieved SVR12.
Slovenian: Ta bolnik je dosegel SVR12.
English: The predominant (>90%) metabolite, GS-331007, is inactive.
Slovenian: Prevladujoči presnovek (> 90 %), GS-331007, ni aktiven.
English: Placebo recipients are not included in the tables since none achieved SVR12.
Slovenian: V preglednice niso vključene osebe, ki so dobivali placebo, saj noben ni dosegel SVR12.
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.
Slovenian: Vrednosti RNA HCV v plazmi so izmerili med kliničnimi študijami s testom COBAS TaqMan za virus HCV (različica 2.0), za uporabo s sistemom High Pure System.
English: The tablet should be taken with food (see section 5.2).
Slovenian: Tableta se jemlje s hrano (glejte poglavje 5.2).
English: Pharmacotherapeutic group: Antivirals for systemic use, direct-acting antiviral; ATC code: J05AP08
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravilo z direktnim delovanjem na viruse, oznaka ATC: J05AP08
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).
Slovenian: Trajanje uporabe zdravila Sovaldi pri bolnikih, ki čakajo na presaditev jeter, naj se ravna po oceni možnih koristi in tveganj pri posamičnem bolniku (glejte poglavje 5.1).
English: No effect = 1.00 b. All interaction studies conducted in healthy volunteers c. Comparison based on historical control d. Administered as Atripla e. Bioequivalence boundary 80%-125% f. Equivalence boundary 70%-143%
Slovenian: Ni učinka = 1,00 b. Vse študije interakcij so opravili pri zdravih prostovoljcih c. Primerjava temelji na zgodovinskih kontrolnih podatkih d. Uporabljeno kot zdravilo Atripla e. Meje bioekvivalence 80 %-125 % f. Meje ekvivalence 70 %-143 %
English: The use of Sovaldi in children under 12 years of age has not yet been studied.
Slovenian: Uporabe zdravila Sovaldi pri otrocih, starih manj kot 12 let, niso preučili.
English: Available pharmacokinetic data in animals have shown excretion of metabolites in milk (for details see section 5.3).
Slovenian: Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje presnovkov v mleko (za podrobnosti glejte poglavje 5.3).
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.
Slovenian: Zaradi dolge razpolovne dobe amiodarona je treba ustrezno spremljati tudi bolnike, ki so prekinili zdravljenje z amiodaronom v zadnjih nekaj mesecih in bodo začeli zdravljenje z zdravilom Sovaldi.
English: • Currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine);
Slovenian: • jemljete ali ste v zadnjih nekaj mesecih jemali zdravilo amiodaron za zdravljenje nerednega srčnega utripa (če jemljete ali ste jemali to zdravilo, bo zdravnik morda razmislil o drugih možnostih zdravljenja)
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.
Slovenian: V tej študiji ob tej ravni odmerka niso opazili neugodnih učinkov, neželeni učinki pa so bili po pogostnosti in resnosti podobni tistim, ki so jih poročali v skupinah, zdravljenih s placebom in sofosbuvirjem 400 mg.
English: 130 mg/daily])
Slovenian: 130 mg/dan])
English: If any of the side effects get serious tell your doctor.
Slovenian: Če kateri od teh neželenih učinkov postane resen, to povejte zdravniku.
English: On-treatment virologic failure < 1% (1/256) Relapseb
Slovenian: Virološki neuspeh med zdravljenjem < 1 % (1/256)
English: • severe headaches (migraine), memory loss, loss of concentration
Slovenian: • hudi glavoboli (migrena), izguba spomina, izguba koncentracije • hujšanje
English: Your liver function may change with treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.).
Slovenian: Zaradi zdravljenja hepatitisa C se lahko delovanje vaših jeter spremeni, kar lahko vpliva na druga zdravila (npr. zdravila za zaviranje imunskega sistema itd.).
English: In rabbit studies exposure to sofosbuvir was 9 times the expected clinical exposure.
Slovenian: V študijah na kuncih je bila izpostavljenost sofosbuvirju 9-krat večja od pričakovane klinične izpostavljenosti.
English: Of the seven patients who did not achieve SVR12, none experienced virologic failure or relapsed.
Slovenian: Od sedmih bolnikov, ki niso dosegli SVR12, ni nobeden doživel virološkega neuspeha ali relapsa.
English: The parent sofosbuvir accounts for approximately 4% of drug-related material systemic exposure (see section 5.2).
Slovenian: Izhodiščni sofosbuvir predstavlja približno 4 % sistemske izpostavljenosti, povezane z zdravilom (glejte poglavje 5.2).
English: If you are sick (vomit) less than 2 hours after taking Sovaldi, take another tablet.
Slovenian: Če bruhate manj kot 2 uri po uporabi zdravila Sovaldi, vzemite še eno tableto.
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%)].
Slovenian: Stopnje SVR12 so bile podobne pri bolnikih z izhodiščnim alelom C/C IL28B [94/95 (99 %)] in alelom ne-C/C (C/T ali T/T) [202/232 (87 %)].
English: It is very important that you also read the leaflets for the other medicines that you will be taking with Sovaldi.
Slovenian: Zelo pomembno je, da preberete tudi navodila za uporabo drugih zdravil, ki jih boste jemali skupaj z zdravilom Sovaldi.
English: Patients with genotype 2 or 3 HCV were enrolled in an approximately 1:3 ratio.
Slovenian: Bolniki s HCV genotipa 2 ali 3 so bili vključeni v razmerju približno 1:3.
English: Effect of baseline HCV polymorphisms on treatment outcome
Slovenian: Učinki izhodiščnega polimorfizma HCV na izid zdravljenja
English: If you are not sure of what medicines can be taken with Sovaldi, talk to your doctor or pharmacist.
Slovenian: Če ste negotovi, katera zdravila lahko jemljete z zdravilom Sovaldi, se posvetujte z zdravnikom ali farmacevtom.
English: Women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded as recommended in the Summary of Product Characteristics for ribavirin.
Slovenian: Ženske v rodni dobi ali njihovi moški partnerji morajo med zdravljenjem in še v obdobju po zaključku zdravljenja uporabljati učinkovito kontracepcijo, kot je priporočeno v povzetku glavnih značilnosti za zdravilo za ribavirin.
English: Sofosbuvir is approximately 85% bound to human plasma proteins (ex vivo data) and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
Slovenian: Vezava sofosbuvirja na beljakovine pri človeku je približno 85-odstotna (podatki ex vivo), ni pa odvisna od koncentracije zdravila v razponu od 1 μg/ml do 20 μg/ml.
English: Sustained virologic response (SVR) was the primary endpoint to determine the HCV cure rate for all studies which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12).
Slovenian: Trajni virološki odziv (SVR-sustained virologic response) je bil primarni opazovani dogodek za ugotovitev stopnje ozdravljenja HCV za vse študije, ki je bil opredeljen kot RNA HCV manj kot LLOQ 12 tednov po koncu zdravljenja (SVR12).
English: • Carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).
Slovenian: • karbamazepin, fenobarbital in fenitoin (zdravila, ki se uporabljajo za zdravljenje epilepsije in preprečevanje epileptičnih napadov).
English: • and you notice within 18 hours of the time you usually take Sovaldi, you must take the tablet as soon as possible.
Slovenian: • in se tega spomnite v roku 18 ur od takrat, ko običajno vzamete zdravilo Sovaldi, morate tableto vzeti takoj, ko je mogoče.
English: Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide.
Slovenian: polivinilalkohol, titanov dioksid, makrogol 3350, smukec, rumeni železov oksid.
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
Slovenian: • nizko število belih krvnih celic (nevtropenija); znaki lahko vključujejo pogostejše okužbe kot običajno, vključno s povečano telesno temperaturo in mrzlicami, vneto žrelo ali razjede v ustih
English: One patient with genotype 3 HCV infection achieved SVR4 but did not return for the SVR12 visit.
Slovenian: En bolnik z okužbo HCV genotipa 3 je dosegel SVR4, vendar se ni vrnil na obisk SVR12.
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.
Slovenian: Sofosbuvir in GS-331007 nista zaviralca P-gp in BCRP, zato se ne pričakuje, da bi povečala izpostavljenost zdravilom, ki so substrati teh prenašalcev.
English: The safety and efficacy of Sovaldi have not been established in patients with decompensated cirrhosis.
Slovenian: Varnost in učinkovitost zdravila Sovaldi pri bolnikih z dekompenzirano cirozo nista bili dokazani.
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.
Slovenian: Zdravilo Sovaldi se sme dajati sočasno z drugimi zdravili z direktnim delovanjem na viruse le, če se na podlagi razpoložljivih podatkov oceni, da je korist zdravljenja večja od tveganj.
English: Haemodialysis can efficiently remove (53% extraction ratio) the predominant circulating metabolite GS-331007.
Slovenian: Hemodializa lahko učinkovito odstrani (53-odstotno ekstrakcijsko razmerje) prevladujoči cirkulirajoči presnovek GS-331007.
English: Tell your doctor if you have kidney problems or if you are on kidney dialysis.
Slovenian: Zdravniku povejte, če imate težave z ledvicami, ali ste na ledvični dializi.
English: • The active substance is sofosbuvir.
Slovenian: • Učinkovina je sofosbuvir.
English: Clinical studies of sofosbuvir included 65 patients aged 65 and over.
Slovenian: Klinične študije za sofosbuvir so vključevale 65 bolnikov,
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).
Slovenian: Če bolnik začetnega odmerka ribavirina ne prenaša dobro, je treba odmerek zmanjšati, kot je klinično indicirano na podlagi ravni hemoglobina (glejte poglavje 5.1).
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir in pregnant women.
Slovenian: Podatkov o uporabi sofosbuvirja pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
English: The highest documented dose of sofosbuvir was a single supratherapeutic dose of sofosbuvir 1,200 mg administered to 59 healthy subjects.
Slovenian: Najvišji dokumentirani odmerek sofosbuvirja je bil en sam supraterapevtski odmerek sofosbuvirja 1.200 mg, ki ga je dobilo 59 zdravih prostovoljcev.
English: Placebo 12 weeks (n = 71)
Slovenian: Placebo 12 tednov (n = 71)
English: The median ribavirin dose was 600 mg-800 mg daily at weeks 4-24.
Slovenian: Mediani odmerek ribavirina je bil 600 mg do 800 mg na dan v 4. do 24. tednu.
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.
Slovenian: Ta priporočila temeljijo na kinetiki absorpcije sofosbuvirja in GS-331007, ki kaže, da se večina odmerka absorbira v roku 2 ur po odmerjanju.
English: Patients were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1 with a CD4+ cell count >200 cells/mm3.
Slovenian: Bolniki bodisi niso prejemali protiretrovirusne terapije s številom celic CD4+ > 500 celic/mm3 ali so imeli HIV-1 z virološko supresijo s številom celic CD4+ > 200 celic/mm3.
English: Contents of the pack and other information What Sovaldi contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Sovaldi
English: In this context, no adverse drug reactions specific to sofosbuvir have been identified.
Slovenian: V tem kontekstu niso ugotovili neželenih učinkov, specifičnih za sofosbuvir.
English: The SVR12 rate was 100% (13/13) in genotype 2 patients and 97% (36/37) in genotype 3 patients.
Slovenian: Stopnja SVR12 je bila 100 % (13/13) pri bolnikih z genotipom 2 in 97 % (36/37) pri bolnikih z genotipom 3.
English: If you forget to take Sovaldi
Slovenian: Če ste pozabili vzeti zdravilo Sovaldi
English: Relative to fasting conditions, the administration of a single dose of sofosbuvir with a standardised high fat meal slowed the rate of absorption of sofosbuvir.
Slovenian: V primerjavi s pogoji na tešče je dajanje enkratnega odmerka sofosbuvirja s standardiziranim obrokom z visoko vsebnostjo maščobe upočasnilo absorpcijo sofosbuvirja.
English: • changes in your mood, feeling depressed, feeling anxious and feeling agitated
Slovenian: • spremembe razpoloženja, občutek potrtosti, občutek tesnobe in občutek vznemirjenosti
English: This is due to liver function changes during treatment with Sovaldi.
Slovenian: Razlog za to so spremembe delovanja jeter pri zdravljenju z zdravilom Sovaldi.
English: Genotype 4, 5 or 6 Cirrhosis
Slovenian: Genotip 4, 5 ali 6 Ciroza
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.
Slovenian: V teh testih je bila protivirusna aktivnost sofosbuvirja in vitro proti manj pogostim genotipom 4, 5 in 6 podobna tisti, ki so jo opazili za genotipe 1, 2 in 3.
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.
Slovenian: Zaporedja NS5B po izhodišču so bila na voljo za 225 od 226 bolnikov, s podatki karakterizacije strukture genoma (deep sequencing) (mejna vrednost testa 1 %) za 221 od teh bolnikov.
English: Mannitol (E421)
Slovenian: Jedro tablete manitol (E421)
English: • chest pain, feeling weak
Slovenian: • bolečine v prsnem košu, občutek šibkosti
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.
Slovenian: Izpostavljenost GS-331007 v teh študijah je bila do 30-krat (miši) in 15-krat (podgane) večja, kot je klinična izpostavljenost sofosbuvirju pri odmerku 400 mg.
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.
Slovenian: Substitucija S282T se je v naslednjih 8 tednih spremenila nazaj v nemutiran tip in je s karakterizacijo strukture genoma 12 tednov po zdravljenju ni bilo več mogoče zaznati.
English: Table 2 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration and cardiac status.
Slovenian: V preglednici 2 so navedene smernice za prilagajanje in ukinitev odmerka na podlagi bolnikovih koncentracij hemoglobina in srčnega statusa.
English: EU/1/13/894/001 28 film-coated tablets EU/1/13/894/002 84 (3 bottles of 28) film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/894/001 28 filmsko obloženih tablet EU/1/13/894/002 84 (3 plastenke po 28) filmsko obloženih tablet
English: Other medicines and Sovaldi
Slovenian: Druga zdravila in zdravilo Sovaldi
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.
Slovenian: Vse bolnike, ki prejemajo zdravilo Sovaldi v kombinaciji z amiodaronom in drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, je treba prav tako opozoriti na simptome bradikardije in srčnega bloka ter jim svetovati, naj ob pojavu simptomov takoj poiščejo zdravniško pomoč.
English: The concordance between SVR12 and SVR24 (SVR 24 weeks after the end of the treatment) following treatment with sofosbuvir in combination with ribavirin or ribavirin and pegylated interferon demonstrates a positive predictive value of 99% and a negative predictive value of 99%.
Slovenian: Ujemanje med SVR12 in SVR24 (SVR 24 tednov po koncu zdravljenja) po zdravljenju s sofosbuvirjem v kombinaciji z ribavirinom ali ribavirinom in pegiliranim interferonom kaže pozitivno napovedno vrednost 99 % in negativno napovedno vrednost 99 %.
English: • shortness of breath or worsening of any shortness of breath you already have Tell your doctor or your pharmacist if you notice any of the above side effects during therapy.
Slovenian: • zasoplost ali poslabšanje že obstoječe zasoplosti Obvestite zdravnika ali farmacevta, če med zdravljenjem opazite katerega od zgornjih neželenih učinkov.
English: 27/28 patients with genotype 4 HCV achieved SVR12.
Slovenian: 27/28 bolnikov s HCV genotipa 4 je doseglo SVR12.
English: NARCOTIC ANALGESICS Methadonef (Methadone maintenance therapy [30 to
Slovenian: NARKOTIČNI ANALGETIKI Metadonf (vzdrževalna terapija z metadonom [30 do
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.
Slovenian: Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom Sovaldi, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
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.
Slovenian: Usmerjena mutageneza substitucije S282T v replikonih 8 genotipov je doprinesla k 2- do 18-krat zmanjšani dovzetnosti za sofosbuvir in zmanjšala replikacijsko sposobnost virusa za 89 % do 99 % v primerjavi z ustreznim nemutiranim tipom virusa.
English: No human data on the effect of Sovaldi on fertility are available.
Slovenian: Podatki o vplivu zdravila Sovaldi na plodnost pri ljudeh niso na voljo.
English: The film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with “GSI” and “7977” on the other side.
Slovenian: Filmsko obložene tablete so rumene tablete v obliki kapsule, z vtisnjeno oznako »GSI« na eni in »7977« na drugi strani.
English: The safety of sofosbuvir in a fixed dose combination with either ledipasvir or velpatasvir has been studied in 154 patients with ESRD requiring dialysis (Study 4062 and Study 4063).
Slovenian: Varnost kombinacije s fiksnim odmerkom sofosbuvirja in ledipasvirja ali velpatasvirja so preučili pri 154 bolnikih z ESRD, ki so potrebovali dializo (študija 4062 in študija 4063).
English: • Modafinil (a medicine to treat people with narcolepsy to help them stay awake).
Slovenian: • modafinil (zdravilo za zdravljenje oseb z narkolepsijo, da ostanejo budni);
English: * Includes patients co-infected with human immunodeficiency virus (HIV).
Slovenian: * Vključno z bolniki, ki imajo sočasno okužbo z virusom humane imunske pomanjkljivosti (HIV).
English: The SVR12 rate in the sofosbuvir + ribavirin treatment group was statistically significant when compared to placebo (p <0.001).
Slovenian: Stopnja SVR12 v skupini, zdravljeni s sofosbuvirjem + ribavirinom, je bila statistično značilna v primerjavi s placebom (p < 0,001).
English: If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Slovenian: Če ima bolnik resne neželene učinke, ki so morebiti povezani z ribavirinom, je treba odmerek ribavirina prilagoditi ali ukiniti, kakor je ustrezno, dokler ni neželeni učinek odpravljen ali postane manj resen.
English: post-transplant (pTVR)b
Slovenian: 12. teden po presaditvi (pTVR)b
English: Vomiting and missed doses
Slovenian: Bruhanje in izpuščeni odmerki
English: • getting a cold (nasopharyngitis)
Slovenian: • prehlad (nazofaringitis)
English: The study was designed as a direct comparison of sofosbuvir and ribavirin versus placebo for 12 weeks.
Slovenian: Študija je bila zasnovana kot neposredna primerjava 12-tedenske uporabe sofosbuvirja in ribavirina v primerjavi s placebom.
English: Interferon intolerant, ineligible or unwilling (POSITRON)
Slovenian: Interferona ne prenašajo, niso primerni ali niso voljni
English: This is because they may make Sovaldi work less well.
Slovenian: Razlog je v tem, ker bo morda v tem primeru zdravilo Sovaldi slabše delovalo.
English: In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite ranged from 8 to 28 times higher than the clinical exposure at 400 mg sofosbuvir.
Slovenian: V študijah na podganah izpostavljenosti sofosbuvirju niso mogli določiti, vendar je razpon meje izpostavljenosti na podlagi glavnega presnovka pri ljudeh od 8- do 28-krat večji od klinične izpostavljenosti sofosbuvirju pri odmerku 400 mg.
English: The most common adverse drug reactions occurring in patients receiving sofosbuvir and ribavirin or sofosbuvir, ribavirin and peginterferon alfa were fatigue, headache, nausea and insomnia.
Slovenian: Najpogostejši neželeni učinki zdravila, ki so se pojavili pri bolnikih, ki so dobivali sofosbuvir in ribavirin ali sofosbuvir, ribavirin in peginterferon alfa, so bili utrujenost, glavobol, navzea in nespečnost.
English: Pregnancy must be avoided due to the use of Sovaldi together with ribavirin.
Slovenian: Nosečnosti med uporabo zdravila Sovaldi skupaj z ribavirinom se je treba izogniti.
English: What you need to know before you take Sovaldi Do not take Sovaldi
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Sovaldi Ne jemljite zdravila Sovaldi
English: In a pooled analysis of 991 patients who received sofosbuvir in Phase 3 studies, 226 patients qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA >1,000 IU/mL.
Slovenian: V združeni analizi 991 bolnikov, ki so prejeli sofosbuvir v študijah 3. faze, je bilo 226 bolnikov primernih za analizo odpornosti zaradi virološkega neuspeha ali predčasne prekinitve uporabe preiskovanega zdravila in zaradi HCV RNA > 1.000 i.e./ml.