natgillin/translations-raw huggingface dataset:
The sofosbuvir-associated resistance substitution S282T was not detected in any of these patients by deep sequencing or population sequencing.
Supstitucija S282T povezana s rezistencijom na sofosbuvir nije otkrivena ni u jednog od ovih bolesnika bilo detaljnim sekvenciranjem ili populacijskim sekvenciranjem.
Protein binding of GS-331007 was minimal in human plasma.
Vezanje GS­331007 za proteine u ljudskoj plazmi bilo je minimalno.
Use with moderate P-gp inducers
Primjena s umjerenim induktorima P­gp­a
The median ribavirin dose was 600 mg-800 mg daily at weeks 4-24.
Medijan doze ribavirina iznosio je 600 mg­800 mg na dan od 4. do 24. tjedna.
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir .
Istodobna primjena amiodarona bila je ograničena tijekom kliničkog razvoja sofosbuvira.
Other special population(s)
Druga(e) posebna(e) populacija(e)
The highest documented dose of sofosbuvir was a single supratherapeutic dose of sofosbuvir 1,200 mg administered to 59 healthy subjects.
Najviša zabilježena doza sofosbuvira bila je jednokratna supraterapijska doza sofosbuvira od 1200 mg primijenjena u 59 zdravih ispitanika.
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.
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.
≥2 g/dL decrease in haemoglobin during any 4 week treatment period
Sniženje hemoglobina za ≥ 2 g/dl tijekom bilo kojeg 4­tjednog razdoblja liječenja
Close monitoring is recommended if this medicinal product is administered with Sovaldi (see sections 4.4 and 4.8).
Preporučuje se pažljivo praćenje ako se ovaj lijek primjenjuje sa Sovaldijem (vidjeti dijelove 4.4 i 4.8).
When you take Sovaldi with ribavirin or both peginterferon alfa and ribavirin, you may get one or more of the side effects below:
Kad uzmete Sovaldi s ribavirinom ili peginterferonom alfa i ribavirinom, možete dobiti jednu ili više sljedećih nuspojava:
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.
Ove se preporuke temelje na kinetici apsorpcije sofosbuvira i GS­331007 koja pokazuje da se većina doze apsorbira u roku od 2 sata nakon primjene.
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.
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.
HCV/HBV (hepatitis B virus) co-infection
Istodobna infekcija HCV/HBV (virus hepatitisa B)
• Carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).
● karbamazepin, fenobarbital i fenitoin (lijekovi koji se primjenjuju za liječenje epilepsije i sprječavanje napadaja).
In this context, no adverse drug reactions specific to sofosbuvir have been identified.
U tom kontekstu nisu utvrđene nikakve nuspojave specifične za sofosbuvir.
* Includes patients co-infected with human immunodeficiency virus (HIV).
* Uključuje bolesnike istodobno zaražene virusom humane imunodeficijencije (HIV).
Sofosbuvir is a nucleotide prodrug.
Sofosbuvir je nukleotidni predlijek.
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.
U ispitivanjima na štakorima, izloženost sofosbuviru nije se mogla odrediti, ali granice izloženosti na temelju glavnog metabolita u ljudi bile su od 8 do 28 puta veće od kliničke izloženosti kod doze od 400 mg sofosbuvira.
No human data on the effect of Sovaldi on fertility are available.
Nema dostupnih podataka o utjecaju Sovaldija na plodnost u ljudi.
Adult liver transplant recipients - Study 0126
Odrasli bolesnici kojima je transplantirana jetra - ispitivanje 0126
* The daily dosage of ribavirin is weight-based and is administered orally in two divided doses with food.
* Dnevna doza ribavirina temelji se na tjelesnoj težini te se primjenjuje peroralno podijeljena u dvije doze s hranom.
The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Veći dio doze sofosbuvira otkrivene u mokraći činio je GS­331007 (78%), dok je 3,5% bilo otkriveno kao sofosbuvir.
The SVR12 rate in the sofosbuvir + ribavirin treatment group was statistically significant when compared to placebo (p <0.001).
Stopa SVR12 u terapijskoj skupini koja je primala sofosbuvir + ribavirin bila je statistički značajna u usporedbi s placebom (p < 0,001).
Sofosbuvir is a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) while GS-331007 is not.
Sofosbuvir je supstrat prijenosnika lijekova P­gp i proteina rezistencije raka dojke (BCRP) dok GS­331007 to nije.
Efficacy, in terms of rapid virologic response, has been shown to correlate with exposure to sofosbuvir as well as GS 331007.
Pokazalo se da djelotvornost, u smislu brzog virološkog odgovora, korelira s izloženošću kako sofosbuviru tako i GS­331007.
This is because they may make Sovaldi work less well.
To je zato što oni mogu oslabiti djelovanje lijeka Sovaldi.
Sofosbuvir retained activity against the NS5B substitutions L159F and L320F associated with resistance to other nucleoside inhibitors.
Sofosbuvir je zadržao djelovanje protiv NS5B supstitucija L159F i L320F povezanih s rezistencijom na druge nukleozidne inhibitore.
If you vomit more than 2 hours after taking it you do not need to take another tablet until your next regularly scheduled tablet.
Ako povratite nakon više od 2 sata nakon uzimanja lijeka, ne trebate uzeti drugu tabletu prije sljedeće prema redovitom rasporedu.
Treatment duration was fixed in each study and was not guided by patients' HCV RNA levels (no response guided algorithm).
Trajanje liječenja bilo je fiksno u svakom ispitivanju i nije ovisilo o razini HCV RNK kod bolesnika (nije se koristio algoritam za liječenje prema odgovoru bolesnika).
The adverse reactions observed were consistent with those observed in clinical studies of Sovaldi plus ribavirin in adults (see Table 6).
Opažene nuspojave bile su u skladu s onima opaženim u kliničkim ispitivanjima Sovaldija plus ribavirin u odraslih (vidjeti tablicu 6).
In the ELECTRON study (N = 11), the duration of peginterferon alfa ranged from 4-12 weeks in combination with sofosbuvir + ribavirin.
U ispitivanju ELECTRON (N = 11), trajanje liječenja peginterferonom alfa kretalo se u rasponu od 4 do 12 tjedana u kombinaciji sa sofosbuvirom + ribavirinom.
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%.
Podudarnost između SVR12 i SVR24 (održanog virološkog odgovora 24 tjedna nakon završetka liječenja) nakon liječenja sofosbuvirom u kombinaciji s ribavirinom ili ribavirinom i pegiliranim interferonom pokazuje pozitivnu prediktivnu vrijednost od 99% i negativnu prediktivnu vrijednost od 99%.
Rilpivirinef (25 mg once daily)
Rilpivirinf (25 mg jedanput na dan)
No liver or heart findings were observed in chronic toxicity studies at exposures 9 times (rat) and 27 times (dog) higher than the clinical exposure.
U ispitivanjima kronične toksičnosti nisu opaženi nikakvi nalazi na jetri ili srcu kod izloženosti koja je 9 puta (štakor) i 27 puta (pas) veća od kliničke izloženosti.
If sofosbuvir is used in combination with peginterferon alfa, and a patient has a serious adverse reaction potentially related to this medicinal product, the peginterferon alfa dose should be reduced or discontinued.
Ako se sofosbuvir primjenjuje u kombinaciji s peginterferonom alfa, a bolesnik ima ozbiljnu nuspojavu potencijalno povezanu s tim lijekom, dozu peginterferona alfa potrebno je sniziti ili prekinuti njegovu primjenu.
Patients should be instructed that if vomiting occurs within 2 hours of dosing an additional tablet should be taken.
Bolesnike treba uputiti da uzmu dodatnu tabletu ako povraćanje nastupi u roku od 2 sata nakon doziranja.
If you do miss a dose:
Ako propustite uzeti dozu:
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir in pregnant women.
Nema podataka ili su podaci o primjeni sofosbuvira u trudnica ograničeni (manje od 300 trudnoća).
No dose adjustment of Sovaldi is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Nije potrebna prilagodba doze Sovaldija u bolesnika s blagim, umjerenim ili teškim oštećenjem jetre (Child­Pugh­Turcotte [CPT] stadij A, B ili C) (vidjeti dio 5.2).
After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of 14C-radioactivity was approximately 0.7.
Nakon jedne doze od 400 mg [14C]­sofosbuvira u zdravih ispitanika, omjer 14C­radioaktivnosti u krvi u odnosu na plazmu bio je približno 0,7.
One patient with genotype 3 HCV infection achieved SVR4 but did not return for the SVR12 visit.
Jedan je bolesnik zaražen HCV­om genotipa 3 postigao SVR4, no nije se vratio na pregled za SVR12.
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.
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.
Patients with genotype 2 or 3 HCV were enrolled in an approximately 1:3 ratio.
Bolesnici s genotipom 2 ili 3 HCV­a bili su uključeni u omjeru od približno 1:3.
Common disturbance in attention migraine, memory impairment, disturbance in attention
Često poremećaj pozornosti migrena, oštećenje pamćenja, poremećaj pozornosti
Co-administration will significantly decrease sofosbuvir plasma concentration and could result in loss of efficacy of Sovaldi (see section 4.5).
Istodobna primjena značajno će smanjiti koncentraciju sofosbuvira u plazmi i tako može dovesti do gubitka djelotvornosti Sovaldija (vidjeti dio 4.5).
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.
Izloženost GS­331007 u ovim ispitivanjima bila je do 30 puta (miš) i 15 puta (štakor) veća od kliničke izloženosti kod doze od 400 mg sofosbuvira.
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.
Sovaldi se ne preporučuje primjenjivati kao monoterapiju, nego ga treba propisivati u kombinaciji s drugim lijekovima za liječenje infekcije hepatitisom C.
Sofosbuvir is a nucleotide prodrug that is extensively metabolised.
Sofosbuvir je nukleotidni predlijek koji se opsežno metabolizira.
The dose linearity of sofosbuvir and its primary metabolite, GS-331007, was evaluated in fasted healthy subjects.
Linearnost doze sofosbuvira i njegovog primarnog metabolita, GS­331007, bila je procijenjena u zdravih ispitanika natašte.
At baseline, two patients had cirrhosis and the mean eGFR was 24.9 mL/min (range: 9.0-39.6).
Na početku ispitivanja dva su bolesnika imala cirozu, a srednja vrijednost eGFR iznosila je 24,9 ml/min (raspon: 9,0­39,6).
Patient population*
Populacija bolesnika*
Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Sofosbuvir se opsežno metabolizira u jetri i nastaje farmakološki aktivan nukleozidni analog trifosfat GS­461203.
Concerning co-administration with other direct-acting antivirals against HCV, see section 4.4.
Za istodobnu primjenu s drugim direktno djelujućim antiviroticima protiv HCV­a, vidjeti dio 4.4.
After oral administration of Sovaldi, sofosbuvir is rapidly absorbed and subject to extensive first-pass hepatic and intestinal metabolism.
Nakon peroralne primjene Sovaldija, sofosbuvir se brzo apsorbira i opsežno se metabolizira kod prvog prolaska kroz jetru i u crijevima.
In study 0126, decreases in haemoglobin during treatment were very common with 32.5% (13/40 patients) experiencing a decline in haemoglobin to <10 g/dL, 1 of whom also had a decline to <8.5 g/dL.
U ispitivanju 0126, sniženje hemoglobina tijekom liječenja bilo je vrlo često, s 32,5% (13/40) bolesnika u kojih je hemoglobin bio snižen na < 10 g/dl, među kojima je u jednog bio snižen na < 8,5 g/dl.
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).
Sigurnost primjene sofosbuvira u fiksnoj kombinaciji s ledipasvirom ili velpatasvirom ispitana je u 154 bolesnika s ESRD­om koji je zahtijevao dijalizu (ispitivanje 4062 i ispitivanje 4063).
Genotype 2 (n = 109)
Genotip 2 (n = 109)
Co-administration of Sovaldi with medicinal products that inhibit P-gp and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma concentration, thus Sovaldi may be co-administered with P-gp and/or BCRP inhibitors.
Istodobna primjena Sovaldija s lijekovima koji inhibiraju P­gp i/ili BCRP može povećati koncentraciju sofosbuvira u plazmi bez povećavanja koncentracije GS­331007 u plazmi pa se stoga Sovaldi može istodobno primjenjivati s inhibitorima P­gp i/ili BCRP.
Co-administration with other direct-acting antivirals against HCV
Istodobna primjena s drugim direktno djelujućim antiviroticima protiv HCV­a
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.
Taj je ispitanik na početku nosio < 1% S282T HCV­a i razvio S282T (> 99%) 4 tjedna nakon liječenja, što je promijenilo vrijednost EC50 sofosbuvira 13,5 puta i smanjilo kapacitet umnažanja virusa.
Table 24: Effect of varying degrees of renal impairment on exposures (AUC) of sofosbuvir and GS-331007 compared to subjects with normal renal function
Tablica 24: Utjecaj različitih stupnjeva oštećenja bubrega na izloženost (AUC) sofosbuviru i GS-331007 u usporedbi s ispitanicima s normalnom funkcijom bubrega
Genotype 3 (n = 98)
Genotip 3 (n = 98)
Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered sofosbuvir dose.
Nakon jedne doze od 400 mg sofosbuvira, tijekom 4 sata hemodijalize uklonilo se 18% primijenjene doze sofosbuvira.
The SVR12 rate was 100% (13/13) in genotype 2 patients and 97% (36/37) in genotype 3 patients.
Stopa SVR12 bila je 100% (13/13) u bolesnika s genotipom 2 i 97% (36/37) u bolesnika s genotipom
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.
Glavni inaktivni cirkulirajući metabolit GS­331007 na koji otpada više od 90% sistemske izloženosti tvarima povezanima s lijekom stvara se slijednim i usporednim putevima nastanka djelatnog metabolita.
Sofosbuvir and GS-331007 exposures in adolescents aged 12 to <18 years were similar to those in adults from Phase 2/3 studies following administration of sofosbuvir (400 mg).
Izloženost sofosbuviru i GS­331007 u adolescenata u dobi od 12 do <18 godina bila je slična izloženosti u odraslih iz ispitivanja faze 2/3 nakon primjene sofosbuvira (400 mg).
Interferon classification Ineligible
Klasifikacija prema interferonu Nisu pogodni
The intracellular metabolic activation pathway of sofosbuvir is mediated by generally low affinity and high capacity hydrolase and nucleotide phosphorylation pathways that are unlikely to be affected by concomitant medicinal products (see section 5.2).
Put aktivacije sofosbuvira unutarstaničnim metabolizmom posredovan je hidrolazom obično niskog afiniteta i visokog kapaciteta i putovima fosforilacije nukleotida na koje istodobno primijenjeni lijekovi najvjerojatnije neće djelovati (vidjeti dio 5.2).
BOTTLE AND CARTON LABELLING
OZNAČIVANJE BOČICE I KUTIJE
• Rifapentine (a medicine used to treat infections, including tuberculosis);
● rifapentin (lijek koji se primjenjuje za liječenje infekcija, uključujući tuberkulozu).
However, if ribavirin is co-administered with sofosbuvir, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics for ribavirin).
Međutim, ako se ribavirin primjenjuje istodobno sa sofosbuvirom, vrijede kontraindikacije za primjenu ribavirina tijekom trudnoće (vidjeti također sažetak opisa svojstava lijeka za ribavirin).
Patients had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic HCV infection pre-transplantation.
Bolesnici su na probiru imali HCV RNK ≥ 104 IU/ml i dokumentiran dokaz kronične infekcije HCV­om prije transplantacije.
Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Defosforilacija dovodi do stvaranja nukleozidnog metabolita GS­331007 koji se ne može učinkovito ponovno fosforilirati i nema anti­HCV djelovanje in vitro.
In clinical pharmacology studies, both sofosbuvir and GS-331007 were monitored for purposes of pharmacokinetic analyses.
U ispitivanjima kliničke farmakologije, i sofosbuvir i GS­331007 bili su praćeni u svrhu farmakokinetičkih analiza.
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).
Održan virološki odgovor (SVR) bio je primarni ishod prema kojem se određivala stopa izlječenja HCV­a u svim ispitivanjima, a definirao se kao HCV RNK manji od LLOQ 12 tjedana nakon završetka liječenja (SVR12).
Refer to the peginterferon alfa Summary of Product Characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose.
Pročitajte sažetak opisa svojstava lijeka za peginterferon alfa zbog dodatnih informacija o tome kako sniziti dozu i/ili prekinuti primjenu peginterferona alfa.
HCV infected patients, 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.
Bolesnici zaraženi HCV­om, bez obzira na genotip, s hepatocelularnim karcinomom (HCC) koji su zadovoljavali kriterije MILAN primali su 400 mg sofosbuvira i 1000­1200 mg ribavirina dnevno tijekom najviše 24 tjedna, naknadno produljeno na 48 tjedana, ili do trenutka transplantacije jetre, štogod je bilo prije.
Infections and infestations: Common nasopharyngitis Blood and lymphatic system disorders:
Poremećaji krvi i limfnog sustava:
Sofosbuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo mouse micronucleus assays.
Sofosbuvir nije bio genotoksičan u bateriji testova in vitro ili in vivo, uključujući test bakterijske mutagenosti, kromosomske aberacije pomoću limfocita iz ljudske periferne krvi i in vivo mišji mikronukleusni test.
In biochemical assays, recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution showed reduced susceptibility to GS-461203 compared to respective wild-types.
U biokemijskim testovima, rekombinantna polimeraza NS5B genotipova 1b, 2a, 3a i 4a koji su izražavali supstituciju S282T pokazala je smanjenu osjetljivost na GS­461203 u usporedbi s odgovarajućim divljim tipovima.
95% of patients received antiretroviral therapy at the time of enrolment.
U vrijeme uključenja, 95% bolesnika primalo je antiretrovirusnu terapiju.
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.
U odnosu na stanje natašte, primjena jedne doze sofosbuvira sa standardiziranim obrokom bogatim mastima usporila je brzinu apsorpcije sofosbuvira.
When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) <50 mL/min (see also section 5.2).
Kad se Sovaldi primjenjuje u kombinaciji s ribavirinom ili peginterferonom alfa/ribavirinom, pročitajte također sažetak opisa svojstava lijeka za ribavirin za bolesnike s klirensom kreatinina (CrCl) < 50 ml/min (vidjeti također dio 5.2).
HIV/HCV co-infection
Istodobna infekcija HIV/HCV
Sovaldi + ribavirin + peginterferon alfa
ribavirin + peginterferon alfa
The difference in the overall SVR12 rates between sofosbuvir + ribavirin and peginterferon alfa + ribavirin treatment groups was 0.3% (95% confidence interval: -7.5% to 8.0%) and the study met the predefined non-inferiority criterion.
Razlika u ukupnoj stopi održanog virološkog odgovora (SVR12) između terapijske skupine koja je primala sofosbuvir + ribavirin i one koja je primala peginterferon alfa + ribavirin iznosila je 0,3% (95% interval pouzdanosti: ­7,5% do 8,0%) i ispitivanje je zadovoljilo unaprijed određeni kriterij neinferiornosti.
Sovaldi should be used in combination with other medicinal products.
Sovaldi treba uzimati u kombinaciji s drugim lijekovima.
Baseline NS5B sequences were obtained for 1,292 patients from Phase 3 studies by population sequencing and the S282T substitution was not detected in any subject with available baseline sequence.
Početne sekvence NS5B dobivene su populacijskim sekvenciranjem za 1292 bolesnika u ispitivanjima faze 3, a S282T supstitucija nije bila otkrivena ni u jednog bolesnika s dostupnom početnom sekvencom.
Sovaldi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Sovaldi je kontraindiciran s fenobarbitalom i fenitoinom (vidjeti dio 4.3).
c. Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
c. Ostalo uključuje bolesnike koji nisu postigli SVR12 i nisu zadovoljili kriterije virološkog neuspjeha (npr. izgubljeni iz praćenja).
A single subject with genotype 5 and all 6 patients with genotype 6 HCV infection in this study achieved SVR12.
Jedan ispitanik s infekcijom genotipom 5 i svih 6 bolesnika s infekcijom genotipom 6 HCV­a u ovom ispitivanju postiglo je SVR12.
In this setting, exposure of sofosbuvir metabolite GS-331007 is 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials.
U takvim okolnostima, izloženost metabolitu sofosbuvira GS­331007 povećana je 20 puta i premašuje razine pri kojima su nuspojave opažene u pretkliničkim ispitivanjima.
Sofosbuvir and GS-331007 AUCs are near dose proportional over the dose range of 200 mg to 400 mg.
AUC sofosbuvira i GS­331007 bili su gotovo proporcionalni dozi u rasponu doza od 200 mg do 400 mg.
When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Kad se Sovaldi primjenjuje u kombinaciji s ribavirinom ili peginterferonom alfa/ribavirinom, potreban je krajnji oprez kako bi se izbjegla trudnoća u bolesnica i partnerica muških bolesnika.
• getting a cold (nasopharyngitis)
● prehlada (nazofaringitis)