FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nonafact, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The dose is also adjusted depending on the severity of the haemorrhage or the type of surgery.
Slovenian: Odmerek je treba prilagoditi tudi glede na stopnjo resnosti krvavitve ali vrsto kirurškega posega.
English: Other information about Nonafact
Slovenian: Druge informacije o zdravilu Nonafact
English: Patients with haemophilia B lack factor IX, and this causes bleeding problems, such as bleeding in the joints, muscle or internal organs.
Slovenian: Bolnikom s hemofilijo B primanjkuje faktorja IX, kar povzroča težave s krvavitvami, kot so krvavenje v sklepe, mišice ali notranje organe.
English: Nonafact is given by infusion into a vein at a rate of no more than 2 ml per minute.
Slovenian: Zdravilo Nonafact se daje z infuzijo v veno s hitrostjo največ 2 ml na minuto.
English: For the full list of all the side effects reported with Nonafact, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nonafact, glejte navodilo za uporabo.
English: What benefit has Nonafact shown during the studies?
Slovenian: Kakšne koristi je zdravilo Nonafact izkazalo med študijami?
English: The doctor will calculate a suitable dose, depending on whether Nonafact is used to treat haemorrhage (bleeding) or to prevent bleeding during surgery.
Slovenian: Zdravnik bo izračunal primeren odmerek glede na to, ali se zdravilo Nonafact uporablja za zdravljenje krvavitev ali za preprečevanje krvavitev med kirurškim posegom.
English: Nonafact must not be used in people who are hypersensitive (allergic) to human coagulation factor IX or to any of the other ingredients, or to mouse proteins.
Slovenian: Zdravila Nonafact ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani koagulacijski faktor IX ali katero koli drugo sestavino ali na mišje beljakovine.
English: Nonafact is used for the treatment and prevention of bleeding in patients with haemophilia B (an inherited bleeding disorder caused by lack of factor IX).
Slovenian: Zdravilo Nonafact se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B (prirojeno motnjo strjevanja krvi zaradi pomanjkanja faktorja IX).
English: What is the risk associated with Nonafact?
Slovenian: Kakšna tveganja so povezana z zdravilom Nonafact?
English: The CHMP decided that Nonafact's benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia B. They recommended that Nonafact be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Nonafact za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo B večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Nonafact contains the active substance human coagulation factor IX, which helps blood to clot.
Slovenian: Nonafact vsebuje zdravilno učinkovino humani koagulacijski faktor IX, ki pomaga pri strjevanju krvi.
English: Nonafact is used to replace the missing factor IX; it corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Slovenian: Z zdravilom Nonafact se nadomesti manjkajoči faktor IX in posledično popravi njegovo pomanjkanje ter vzpostavi začasni nadzor nad krvavitvami.
English: Nonafact is a powder and solvent that are mixed together to form a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Nonafact sestavljata prašek in vehikel, ki se zmešata v raztopino za infundiranje (kapalno infuzijo v veno).
English: Nonafact contains human coagulation factor IX, a protein extracted and purified from human plasma (the liquid part of the blood).
Slovenian: Zdravilo Nonafact vsebuje humani koagulacijski factor IX, ki je pridobljen in prečiščen iz človeške plazme (tekočega dela krvi).
English: Hypersensitivity (allergic reactions) has been sometimes seen in patients treated with factor IX-containing products.
Slovenian: Občasno so pri bolnikih, zdravljenih z zdravili, ki vsebujejo faktor IX, zabeležili preobčutljivostne (alergične) reakcije.
English: Why has Nonafact been approved?
Slovenian: Zakaj je bilo zdravilo Nonafact odobreno?
English: Haemophilia B patients may develop antibodies (inhibitors) to factor IX.
Slovenian: Pri bolnikih s hemofilijo B se lahko razvijejo protitelesa (zaviralci) faktorja IX.
English: How has Nonafact been studied?
Slovenian: Kako je bilo zdravilo Nonafact raziskano?
English: How does Nonafact work?
Slovenian: Kako zdravilo Nonafact deluje?
English: How is Nonafact used?
Slovenian: Kako se zdravilo Nonafact uporablja?
English: Nonafact was rated as “good” or “excellent” in its ability to prevent bleeding in patients with haemophilia B.
Slovenian: Učinkovitost zdravila Nonafact za preprečevanje krvavitev pri bolnikih s hemofilijo B je bila ocenjena kot „dobra“ ali „odlična“.
English: What is Nonafact?
Slovenian: Kaj je zdravilo Nonafact?
English: What is Nonafact used for?
Slovenian: Za kaj se zdravilo Nonafact uporablja?
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 January 2014
Slovenian: Datum prve odobritve: 16. januar 2014
English: Furthermore, the appropriate dose has not been established.
Slovenian: Poleg tega ustrezni odmerek ni bil določen.
English: Preliminary SVR12 data are available for 210 subjects.
Slovenian: Predhodni podatki SVR12 so na voljo za 210 oseb.
English: It will not work on its own.
Slovenian: Zdravilo ne deluje samo po sebi.
English: Eight subjects (20%) received epoetin and/or a blood product.
Slovenian: Osem oseb (20 %) je prejelo epoetin in/ali krvi pripravek.
English: Do not give this medicine to children and adolescents under 18 years of age.
Slovenian: Otroci in mladostniki Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let.
English: In 5 subjects (12.5%), study drugs were discontinued, modified or interrupted due to adverse events.
Slovenian: 5 osebah (12,5 %) so uporabo študijskega zdravila zaradi neželenih učinkov ukinili, prilagodili ali prekinili.
English: The response rates observed for subjects over 65 years of age were similar to that of younger subjects across treatment groups.
Slovenian: Stopnje odziva, ki so jih opazili pri osebah, starejših od 65 let, so bile podobne kot pri mlajših osebah v vseh skupinah zdravljenja.
English: • If you are allergic to sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Slovenian: • če ste alergični na sofosbuvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
English: * Includes patients co-infected with human immunodeficiency virus (HIV).
Slovenian: * Vključno z bolniki, ki imajo sočasno okužbo z virusom človeške imunske pomanjkljivosti (HIV).
English: Response rates for selected subgroups are presented in Table 6.
Slovenian: Stopnje odzivov za izbrane podskupine so prisotne v preglednici 6.
English: This includes herbal medicines and medicines obtained without a prescription.
Slovenian: To vključuje tudi zeliščne pripravke in zdravila, ki ste jih dobili brez recepta.
English: Non-Black
Slovenian: Črnci Ne-črnci
English: Most subjects had no prior HCV treatment (81.3%).
Slovenian: Največ oseb se predhodno še niso zdravili zaradi HCV (81,3 %).
English: The proportions of subjects who were interferon intolerant, ineligible, or unwilling were 9%, 44%, and 47%, respectively.
Slovenian: Razmerje med osebami, ki so interferona niso prenašale, niso bile primerne oz. volje, je bilo 9 %, 44 % in 47 %.
English: EU/1/13/894/002
Slovenian: EU/1/13/894/001 EU/1/13/894/002
English: Placebo recipients are not included in the tables since none achieved SVR12.
Slovenian: V preglednice niso vključene osebe, ki so dobivale placebo, saj nobena ni dosegla SVR12.
English: Clinical studies of sofosbuvir included 65 subjects aged 65 and over.
Slovenian: Klinične študije za sofosbuvir so vključevale 65 oseb, starih 65 let in več.
English: Interferon intolerant, ineligible or unwilling (POSITRON)
Slovenian: Interferona ne prenašajo, niso primerni ali niso voljni (POSITRON)
English: Patients awaiting liver transplantation - Study 2025
Slovenian: Bolniki, ki čakajo na presaditev jeter - študija 2025
English: Liver transplant recipients - Study 0126
Slovenian: Prejemniki presajenih jeter - študija 0126
English: Treatment-experienced (LONESTAR-2b)
Slovenian: Predhodno zdravljeni (LONESTAR-2b)
English: • severe headaches (migraine), memory loss, loss of concentration
Slovenian: • hudi glavoboli (migrena), izguba spomina, izguba koncentracije
English: Subjects in these studies had compensated liver disease including cirrhosis.
Slovenian: Osebe v teh študijah so imele kompenzirano bolezen jeter, vključno s cirozo.
English: Pharmacotherapeutic group: Direct-acting antiviral; ATC code: J05AX15
Slovenian: Farmakoterapevtska skupina: zdravilo z direktnim delovanjem na viruse; oznaka ATC: J05AX15
English: Virologic response in evaluable subjectsa a. Evaluable subjects are defined as those who have reached the specified time point at the time of the interim analysis.
Slovenian: Virološki odziv pri osebah, primernih za oceniteva a. Osebe, primerne za ocenitev, so opredeljene kot osebe, ki so v času vmesne analize dosegle specificirano časovno točko.
English: All subjects who achieved SVR12 achieved SVR24 and SVR48.
Slovenian: Vse osebe, ki so dosegle SVR12, so dosegle SVR24 in SVR48.
English: ANALEPTICS Modafinil
Slovenian: ANALEPTIKI Modafinil
English: Sovaldi is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this population.
Slovenian: Uporaba zdravila Sovaldi se ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let, saj varnost in učinkovitost pri tej populaciji nista bili dokazani.
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir.
Slovenian: Prisotnost 40 % humanega seruma ni vplivala na aktivnost sofosbuvirja proti HCV. Odpornost
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.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če imate hude težave z ledvicami ali če ste na ledvični dializi, saj učinkov zdravila Sovaldi na bolnike s hudimi težavami z ledvicami niso v celoti preučili.
English: The film-coated tablet is for oral use.
Slovenian: Filmsko obložena tableta je za peroralno uporabo.
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
Slovenian: Neželeni učinki so po pogostnosti opredeljeni kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) ali zelo redki (< 1/10.000).
English: SVR12 rate % (n/N)
Slovenian: Podskupina Stopnja SVR12 % (n/N)
English: ↔ GS-331007 (TPV or BOC)
Slovenian: ↔ GS-331007 (TPV ali BOC)
English: • Rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
Slovenian: • rifampicin in rifabutin (antibiotika, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo);
English: If you accidentally take more than the recommended dose you should contact your doctor or nearest emergency department immediately for advice.
Slovenian: Če ste pomotoma vzeli večji odmerek od priporočenega, se takoj posvetujte z zdravnikom ali pojdite na najbližji oddelek nujne pomoči.
English: Blood tests may also show:
Slovenian: • zasoplost, kašelj Krvne preiskave lahko pokažejo tudi:
English: Subjects with genotype 2 or 3 HCV were enrolled in an approximately 1:3 ratio.
Slovenian: Osebe s HCV genotipa 2 ali 3 so bile vključene v razmerju približno 1:3.
English: Available pharmacokinetic data in animals has 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: SVR12 rates were similarly high in subjects 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 osebah z izhodiščnim alelom C/C IL28B [94/95 (99 %)] in alelom ne-C/C (C/T ali T/T) [202/232 (87 %)].
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
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: (600 mg single dose)
Slovenian: (600 mg enkratni odmerek)
English: Outcome for subjects without SVR12
Slovenian: Izid za osebe brez SVR12
English: (400 mg twice daily)
Slovenian: (400 mg dvakrat na dan)
English: The AUC0-inf of GS-331007 in subjects with ESRD could not be reliably determined.
Slovenian: AUC0-inf GS-331007 pri osebah z ESRD ni bilo mogoče zanesljivo določiti.
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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s sofosbuvirjem za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: IMMUNOSUPPRESSANTS Ciclosporine
Slovenian: IMUNOSUPRESIVI Ciklosporine
English: INFORMATION IN BRAILLE Sovaldi [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Sovaldi [samo zunanja ovojnina]
English: What Sovaldi is and what it is used for What you need to know before you take Sovaldi How to take Sovaldi
Slovenian: Kaj je zdravilo Sovaldi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Sovaldi Kako jemati zdravilo Sovaldi
English: What Sovaldi is and what it is used for
Slovenian: Kaj je zdravilo Sovaldi in za kaj ga uporabljamo
English: Treatment duration was fixed in each study and was not guided by subjects' 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 oseb (brez algoritma, vodenega z odzivi).
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: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill, County Cork Ireland
Slovenian: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill,County Cork Irska
English: The assay had a lower limit of quantification (LLOQ) of 25 IU/mL.
Slovenian: Test je imel spodnjo mejo kvantifikacije (LLOQ, lower limit of quantification) 25 i.e./ml.
English: The use of Sovaldi in children and adolescents has not yet been studied.
Slovenian: Uporabe zdravila Sovaldi pri otrocih in mladostnikih niso preučili.
English: Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide.
Slovenian: Filmska obloga: polivinilalkohol, titanov dioksid, makrogol 3350, smukec, rumeni železov oksid.
English: Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Slovenian: Zdravljenje z zdravilom Sovaldi mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi bolnikov s CHC.
English: Posology The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2).
Slovenian: Priporočeni odmerek je ena 400-miligramska tableta peroralno enkrat na dan s hrano (glejte poglavje 5.2).
English: On-treatment virologic failure
Slovenian: Virološki neuspeh med zdravljenjem
English: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
Slovenian: Pričakovane: ↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC)
English: c. Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Slovenian: c. Med drugo so bile vključene osebe, ki niso dosegle SVR12 in niso izpolnjevale kriterijev za virološki neuspeh (npr. izgubljeni za spremljanje).
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: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b) Yellow iron oxide (E172)
Slovenian: Filmska obloga polivinilalkohol (E1203) titanov dioksid (E171) makrogol 3350 (E1521) smukec (E553b) rumeni železov oksid (E172)
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV: ZAVIRALCI INTEGRAZE Raltegravirf
English: b. Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Slovenian: b. Med drugo so bile vključene osebe, ki niso dosegle SVR12 in niso izpolnjevale kriterijev za virološki neuspeh (npr. izgubljeni za spremljanje).
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.
Slovenian: Prevladujoči neaktivni cirkulirajoči presnovek GS-331007, ki predstavlja več kot 90 % sistemske izpostavljenosti, povezane z zdravilom, nastaja zaporedno in vzporedno z nastajanjem aktivnega presnovka.
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.
Slovenian: Zaporedja NS5B po izhodišču so bila na voljo za 225 od 226 oseb, s podatki karakterizacije strukture genoma (deep sequencing) (mejna vrednost testa 1 %) za 221 od teh oseb.
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.
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 v kombinaciji z drugim zdravilom z direktnim delovanjem na viruse.
English: Cirrhosis n = number of subjects with SVR12 response; N = total number of subjects per group.
Slovenian: Ciroza n = število oseb z odzivom SVR12; N = skupno število oseb v skupini.
English: Haemoglobin in subjects with no cardiac disease
Slovenian: Hemoglobin pri osebah brez bolezni srca
English: Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults of 18 years and older.
Slovenian: Zdravilo Sovaldi vsebuje zdravilno učinkovino sofosbuvir, ki se daje za zdravljenje okužbe z virusom hepatitisa C pri odraslih, starih 18 let in več.
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: 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: Table 3: Interactions between Sovaldi and other medicinal products Medicinal product by therapeutic areas
Slovenian: Preglednica 3: Interakcije med zdravilom Sovaldi in drugimi zdravili Zdravila po terapevtskih področjih
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.
Slovenian: Ta oseba je bila ob izhodišču nosilec < 1 % HCV S282T in je razvila S282T (> 99 %) 4 tedne po zdravljenju, kar je povzročilo 13,5-kratno spremembo EC50 za sofosbuvir in zmanjšalo replikacijsko sposobnost virusa.
English: If you take more Sovaldi than you should
Slovenian: Če ste vzeli večji odmerek zdravila Sovaldi, kot bi smeli
English: • changes in your liver (as shown by increased amounts of a substance called bilirubin in the blood)
Slovenian: • spremembe na jetrih (kar kaže povečanje snovi, imenovane bilirubin, v krvi) Pogosti neželeni učinki
English: However, data indicate at least 10-fold and 20-fold higher exposure to GS-331007 in ESRD compared to normal subjects when Sovaldi was administered 1 hour before or 1 hour after haemodialysis, respectively.
Slovenian: Vendar pa podatki kažejo vsaj 10-krat oz. 20-krat večjo izpostavljenost GS-331007 pri osebah z ESRD v primerjavi z osebami z normalnim delovanjem ledvic pri dajanju zdravila Sovaldi 1 uro pred hemodializo oz. 1 uro po njej.
English: The safety of Sovaldi has not been assessed in patients with severe renal impairment or ESRD (see section 4.4).
Slovenian: Varnosti zdravila Sovaldi niso ocenili pri bolnikih s hudo ledvično okvaro ali ESRD (glejte poglavje 4.4).
English: Treatment-experienced (FUSION)
Slovenian: Predhodno zdravljeni (FUSION)
English: The proportion of subjects who permanently discontinued treatment due to adverse reactions was 1.4% for subjects receiving placebo, 0.5% for subjects receiving sofosbuvir + ribavirin for 12 weeks, 0% for subjects receiving sofosbuvir + ribavirin for 16 weeks, 11.1% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2.4% for subjects receiving sofosbuvir + peginterferon alfa + ribavirin for 12 weeks.
Slovenian: Delež oseb, ki so zaradi neželenih učinkov trajno prekinile zdravljenje, je bil 1,4 % oseb, ki so prejemale placebo, 0,5 % oseb, ki so 12 tednov prejemale sofosbuvir + ribavirin, 0 % oseb, ki so 16 tednov prejemale sofosbuvir + ribavirin, 11,1 % oseb, ki so 24 tednov prejemale peginterferon alfa + ribavirin in 2,4 % oseb, ki so 12 tednov prejemale sofosbuvir + peginterferon alfa + ribavirin.
English: Treatment-naïve (QUANTUMb and
Slovenian: Predhodno nezdravljeni (QUANTUMb in
English: In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 subjects) experiencing a decline in haemoglobin to <10 g/dL, 1 of whom also had a decline to <8.5 g/dL.
Slovenian: V študiji 0126 so bila med zdravljenjem zelo pogosta zmanjšanja hemoglobina, pri čemer je prišlo pri 32,5 % (13/40 oseb) do zmanjšanja hemoglobina na < 10 g/dl, pri 1 osebi celo do zmanjšanja na < 8,5 g/dl.
English: In a pooled analysis of 991 subjects who received sofosbuvir in Phase 3 studies, 226 subjects 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 oseb, ki so prejele sofosbuvir v študijah 3. faze je bilo 226 oseb primernih za analizo odpornosti zaradi virološkega neuspeha ali predčasne prekinitve uporabe preiskovanega zdravila in zaradi HCV RNA > 1.000 i.e./ml.
English: • If you or your partner become pregnant during Sovaldi treatment or in the months that follow, you must contact your doctor immediately.
Slovenian: • Če vi ali vaša partnerka med zdravljenjem z zdravilom Sovaldi ali v mesecu, ki mu sledi,
English: • low red blood cell count (anaemia); the signs may include feeling tired, headaches, shortness of breath when exercising
Slovenian: • nizko število rdečih krvnih celic (anemija); znaki lahko vključujejo občutek utrujenosti,