natgillin/translations-raw huggingface dataset:
As liver function may change during treatment with Vosevi, close monitoring of International Normalised Ratio (INR) values is recommended.
Ker se delovanje jeter v času zdravljenja z zdravilom Vosevi lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR- International Normalised Ratio).
Each film-coated tablet contains 117 mg of lactose (as lactose monohydrate).
Ena filmsko obložena tableta vsebuje 117 mg laktoze (v obliki laktoze monohidrata).
Co-administration of Vosevi with medicinal products that are substrates of these transporters may increase the exposure of such medicinal products.
Sočasna uporaba zdravila Vosevi z zdravili, ki so substrati teh prenašalcev, lahko poveča izpostavljenost takšnim zdravilom.
The effects of Vosevi during pregnancy are not known.
Učinki zdravila Vosevi med nosečnostjo niso znani.
• if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
• če imate hepatitis B ali ste kdaj bili okuženi z virusom hepatitisa B, saj vas bo morda zdravnik spremljal bolj skrbno;
What Vosevi is and what it is used for
Kaj je zdravilo Vosevi in za kaj ga uporabljamo
The recommended durations of treatment applicable to all HCV genotypes are shown in Table 1.
Priporočena trajanja zdravljenj, ki veljajo za vse genotipe HCV, so prikazana v preglednici 1.
• rosuvastatin (a medicine used to treat high blood cholesterol or decrease the risk of certain cardiovascular events);
• rosuvastatin (zdravilo, ki se uporablja za zdravljenje visokih ravni holesterola v krvi ali zmanjševanje tveganja nekaterih srčnožilnih dogodkov);
These medicines can decrease the amount of Vosevi in your blood.
Ta zdravila lahko zmanjšajo količino zdravila Vosevi v krvi.
The safety and efficacy of Vosevi in children and adolescents aged less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Vosevi pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.8-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 18-fold↑
1,6-krat↑ 2,1-krat↑ 2,7-krat↑ 1,3-krat↑ 1,6- krat↑ ~2- krat↑ 1,8- krat↑ GS-331007 1,6-krat↑ 1,9-krat↑ 5,5-krat↑ ≥10-krat↑ ≥20-krat↑ ~7- krat↑ 18- krat↑ Velpatasvir
If you are pregnant, think you may be pregnant, are breast-feeding your baby, or are planning to have a baby ask your doctor for advice before taking this medicine.
Če ste noseči, dojite, menite, da bi lahko bili noseči, dojite otroka ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
• abnormality in a laboratory test of liver function (total bilirubin)
• nenormalne vrednosti laboratorijskih preiskav delovanja jeter (celokupni bilirubin)
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 Vosevi.
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 Vosevi.
If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Vosevi.
Če jemljete antacid, ga vzemite vsaj 4 ure pred zdravilom Vosevi ali najmanj 4 ure po tem.
If you forget to take Vosevi
Če ste pozabili vzeti zdravilo Vosevi
• ethinylestradiol containing medicines, including many contraceptives.
• zdravila, ki vsebujejo etinilestradiol, vključno s številnimi kontraceptivi.
Caution is warranted and therapeutic concentration monitoring of digoxin is recommended.
Potrebna je previdnost, priporoča se tudi spremljanje terapevtske koncentracije digoksina.
No patients in the placebo group achieved SVR4.
V skupini, ki je prejemala placebo, noben bolnik ni dosegel SVR4.
The difference in SVR12 was driven by a lower response rate in patients with genotype 1a infection and/or cirrhosis.
Razlika v SVR12 je bila posledica nizke stopnje odziva pri bolnikih z okužbo genotipa 1a in/ali s cirozo.
Clinical studies of Vosevi included 189 patients aged 65 and over (17% of total number of patients in the Phase 2 and 3 clinical studies).
V klinične študije zdravila Vosevi je bilo vključenih 189 bolnikov, starih 65 let ali več (17 % skupnega števila bolnikov v kliničnih študijah 2. in 3. faze).
If vomiting occurs more than 4 hours after dosing, no further dose of Vosevi is needed (see section 5.1).
Če se bruhanje pojavi več kot 4 ure po odmerjanju, dodaten odmerek zdravila Vosevi ni potreben (glejte poglavje 5.1).
In healthy volunteer studies with sofosbuvir and velpatasvir, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups.
V študijah z zdravimi prostovoljci s sofosbuvirjem in velpatasvirjem ob teh ravneh odmerkov niso opazili neugodnih učinkov, neželeni učinki pa so bili po pogostnosti in resnosti podobni tistim, o katerih so poročali v skupinah, ki so prejemale placebo.
Animal studies have shown a possible link to reproductive toxicity (see section 5.3).
Študije na živalih so pokazale možno povezavo z reproduktivno toksičnostjo (glejte poglavje 5.3).
• you 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).
• jemljete ali ste v zadnjih nekaj mesecih jemali amiodaron za zdravljenje nerednega srčnega utripa (če jemljete ali ste jemali to zdravilo, bo zdravnik morda razmislil o drugih možnostih zdravljenja).
Carcinogenicity studies for voxilaprevir have not been conducted.
Študij kancerogenosti voksilaprevirja niso izvedli.
The use of Vosevi in children and adolescents has not yet been studied.
Uporabe zdravila Vosevi pri otrocih in mladostnikih niso preučevali.
HCV/HBV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Pri bolnikih s sočasno okužbo s HCV in HBV obstaja tveganje za reaktivacijo HBV, zato jih je treba spremljati in nadzirati v skladu s trenutnimi kliničnimi smernicami.
Active
Aktiven
Some of the active substances of Vosevi may pass into human breast milk.
Nekatere od učinkovin v zdravilu Vosevi morda prehajajo v materino mleko.
Voxilaprevir is approximately > 99% bound to human plasma proteins.
Voksilaprevir se približno > 99-odstotno veže na humane beljakovine v plazmi.
The recommended dose of Vosevi is one tablet, taken orally, once daily with food (see section 5.2).
Priporočeni odmerek zdravila Vosevi je ena tableta peroralno enkrat na dan s hrano (glejte poglavje 5.2).
Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP56
Farmakoterapevtska skupina: zdravila z neposrednim delovanjem na viruse, oznaka ATC: J05AP56 Mehanizem delovanja
This may make Vosevi work less well.
Zaradi tega bo morda zdravilo Vosevi slabše delovalo.
Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Zdravilo Vosevi je indicirano za zdravljenje kronične okužbe z virusom hepatitisa C (HCV) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
Table 8: Studies conducted with Vosevi
Preglednica 8: Študije, ki so jih izvedli z zdravilom Vosevi Študija
A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Vosevi compared to subjects with normal renal function, as described in the text below, are provided in Table 15.
Ledvična okvara Povzetek učinka različnih stopenj ledvične okvare na izpostavljenost sestavinam zdravila Vosevi v primerjavi z osebami z normalnim delovanjem ledvic, kot je opisano spodaj, so na voljo v preglednici 15.
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).
Varnost kombinacije s fiksnim odmerkom sofosbuvirja in bodisi ledipasvirja ali velpatasvirja so preučili pri 154 bolnikih z ESRD, ki so potrebovali dializo (študija 4062 in študija 4063).
Should direct Xa inhibitor use be deemed necessary, apixaban or rivaroxaban may be considered.
Če se oceni, da je potrebna uporaba neposrednega zaviralca Xa, se lahko razmisli o uporabi apiksabana ali rivaroksabana.
c. Pharmacokinetic data for the 1 patient with on-treatment virologic failure was consistent with non-adherence.
c. Farmakokinetični podatki za enega bolnika z virološkim neuspehom med zdravljenjem so bili v skladu z neupoštevanjem zdravljenja.
Total bilirubin levels decreased after completing Vosevi treatment.
Ravni celokupnega bilirubina so se po končanem zdravljenju z zdravilom Vosevi zmanjšale.
For sofosbuvir, the NS5B substitution S282T was selected in genotype 1-6 replicons and was associated with 2- to 18-fold reduced susceptibility to sofosbuvir.
Za sofosbuvir je bila substitucija S282T v NS5B selekcionirana v replikonih genotipov 1-6 in je bila povezana z 2- do 18-kratno zmanjšano dovzetnostjo za sofosbuvir.
1.4-fold↑
1,4- krat↑
Table 2 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined interaction boundaries).
V preglednici 2 je seznam ugotovljenih ali možnih klinično pomembnih interakcij med zdravili (pri čemer je bil 90-odstotni interval zaupanja [IZ] povprečnega razmerja (geometrično povprečje po metodi najmanjših kvadratov [GLSM, geometric least-squares mean]) znotraj „↔“, razširjen nad „↑“ ali razširjen pod „↓“ vnaprej določene meje interakcij).
The European Medicines Agency has deferred the obligation to submit the results of studies with sofosbuvir/velpatasvir/voxilaprevir in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s sofosbuvirjem/velpatasvirjem/voksilaprevirjem za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Table 1: Recommended treatment durations for Vosevi for all HCV genotypes
Preglednica 1: Priporočeno trajanje zdravljenja za zdravilo Vosevi za vse genotipe HCV Populacija bolnikov
Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Posledično bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze tega zdravila ne smejo jemati.
Patients should be instructed to swallow the tablet whole with food (see section 5.2).
Bolnikom je treba naročiti, naj pogoltnejo celo tableto s hrano (glejte poglavje 5.2).
Patients treated with ethinylestradiol-containing medicinal products
Bolniki, ki prejemajo zdravila, ki vsebujejo etinilestradiol
The hydrolysed and dehydrogenated voxilaprevir were the major metabolites identified in human plasma.
Hidrolizirani in dehidrogenirani voksilaprevir sta bila glavna presnovka, ugotovljena v plazmi pri človeku.
The safety and efficacy of Vosevi in the treatment of HCV infection in patients who are post-liver transplant have not been assessed.
Varnost in učinkovitost zdravila Vosevi pri zdravljenju bolnikov z okužbo s HCV po presaditvi jeter nista bili ocenjeni.
8 weeks may be considered in genotype 3 infected patients (see section 5.1)
12 tednov za bolnike, okužene z genotipom 3, je možno razmisliti o 8 tednih (glejte poglavje 5.1)
* 29% of patients enrolled into POLARIS-3 had received prior treatment with an interferon-based regimen.
* 29 % bolnikov, ki so bili vključeni v študijo POLARIS-3, je prejelo predhodno zdravljenje z režimom na osnovi interferona.
* 23% of patients enrolled into POLARIS-2 had received prior treatment with an interferon-based regimen.
* 23 % bolnikov, ki so bili vključeni v študijo POLARIS-2, je prejelo predhodno zdravljenje z režimom na osnovi interferona.
Do not stop taking Vosevi
Ne prenehajte jemati zdravila Vosevi
• atorvastatin, pravastatin, or other statins, used to treat high cholesterol;
• atorvastatin, pravastatin ali druge statine, ki se uporabljajo za zdravljenje visokih ravni holesterola;
As a precautionary measure, Vosevi use is not recommended during pregnancy.
Kot previdnostni ukrep uporaba zdravila Vosevi ni priporočljiva med nosečnostjo.
GS-461203 is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
GS-461203 ni niti zaviralec polimeraz DNK in RNK pri človeku niti ne zavira mitohondrijske polimeraze RNK.
All patients receiving Vosevi 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.
Vse bolnike, ki prejemajo zdravilo Vosevi 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.
Sofosbuvir, velpatasvir, and voxilaprevir were fully active against substitutions associated with resistance to other classes of DAAs with different mechanisms of actions, e.g. voxilaprevir was fully active against NS5A and NS5B NI RAVs.
Sofosbuvir, velpatasvir in voksilaprevir so bili v celoti aktivni proti substitucijam, povezanim z odpornostjo na DAA drugih razredov z različnimi mehanizmi delovanja, npr. voksilaprevir je bil v celoti aktiven proti RAV NI NS5A in NS5B.
Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Vosevi.
Kadar se presodi, da je sočasna uporaba amiodarona potrebna, se ob uvajanju zdravljenja z zdravilom Vosevi priporoča skrbno spremljanje bolnikov.
The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Sušilno sredstvo iz silikagela je v posebni vrečki ali plastenki in ga ne smete pogoltniti.
Co-administration of Vosevi with atazanavir is expected to increase the concentration of voxilaprevir.
Pri uporabi zdravila Vosevi z atazanavirjem se pričakuje, da se bo povečala koncentracija voksilaprevirja.
Voxilaprevir (studied under fed conditions) AUC increases in a greater than doseproportional manner over the dose range of 100 to 900 mg.
Vrednost AUC za voksilaprevir (pri preiskavah po jedi) se poviša več kot sorazmerno z odmerkom v razponu odmerka 100-900 mg.
Vosevi treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Zdravljenje z zdravilom Vosevi mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi bolnikov z okužbo s HCV.
DAA: direct-acting antiviral; GT: genotype; SOF: sofosbuvir; VEL: velpatasvir; VOX: voxilaprevir
DAA: zdravilo z neposrednim delovanjem na viruse; GT: genotip; SOF: sofosbuvir; VEL: velpatasvir; VOKS: voksilaprevir
Sofosbuvir and GS-331007 are not inhibitors or inducers of CYP or uridine glucuronosyltransferase (UGT) 1A1 enzymes.
Sofosbuvir in GS-331007 nista zaviralca ali induktorja encimov CYP ali uridin glukuroniltransferaze (UGT) 1A1.
Medicinal products that are strong OATP1B inhibitors (e.g. ciclosporin) may substantially increase voxilaprevir plasma concentrations, the safety of which has not been established.
Zdravila, ki so močni zaviralci OATP1B (npr. ciklosporin) lahko znatno povečajo koncentracije voksilaprevirja v plazmi, varnost tega pa ni bila ugotovljena.
These should be taken at least 4 hours before or 4 hours after Vosevi;
Te je treba vzeti vsaj 4 ure pred uporabo zdravila Vosevi ali 4 ure po tem;
• tenofovir disoproxil fumarate, or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
• dizoproksiltenofovirijev fumarat ali katero koli zdravilo, ki vsebuje dizoproksiltenofovirijev fumarat, ki se uporablja za zdravljenje okužbe z virusom HIV;
Table 15: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of SOF, GS331007, Velpatasvir and Voxilaprevir Compared to Subjects with Normal Renal Function
Preglednica 15: Učinek različnih stopenj ledvične okvare na izpostavljenosti (AUC) SOF, GS-331007, velpatasvirju in voksilaprevirju v primerjavi z osebami z normalnim delovanjem ledvic
No specific antidote is available for overdose with Vosevi.
Specifični antidot za prevelik odmerek zdravila Vosevi ni na voljo.
No human data on the effect of Vosevi on fertility are available.
Podatki o vplivu zdravila Vosevi na plodnost pri ljudeh niso na voljo.
Effect on fluvastatin, lovastatin, pitavastatin and simvastatin not studied.
Učinka na fluvastatin, lovastatin, pitavastatin in simvastatin niso preučevali.
The NS5B NI RAV S282T was not detected in any patient in POLARIS-2 and POLARIS-3 studies.
RAV NI NS5B S282T niso zaznali pri nobenem bolniku v študijah POLARIS-2 in POLARIS-3.
Your doctor will test your blood before, during and after your treatment with Vosevi.
Zdravnik vam bo pred zdravljenjem z zdravilom Vosevi, med njim in po njem opravil krvne preiskave.
Haemodialysis is unlikely to result in significant removal of velpatasvir or voxilaprevir since velpatasvir and voxilaprevir are highly bound to plasma proteins.
Ni verjetno, da bi hemodializa pomembno odstranila velpatasvir ali voksilaprevir, saj se velpatasvir in voksilaprevir v veliki meri vežeta na beljakovine v plazmi.
The film-coated tablets are beige, capsule-shaped tablets debossed with “GSI” on one side and “3” on the other side.
Filmsko obložene tablete so bež tablete v obliki kapsule, z vtisnjeno oznako „GSI“ na eni in „3“ na drugi strani.
For voxilaprevir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were Q41H, A156V/T/L and D168E/H/Y.
Za voksilaprevir v replikonih genotipa 1-6 so bile z odpornostjo povezane substitucije, selekcionirane v 2 ali več genotipih, Q41H, A156V/T/L in D168E/H/Y.
Of the 31 patients enrolled, 74% (23/31) were male, 81% (25/31) were white, 71% (22/31) had a baseline body mass index < 30 kg/m2, 48% (15/31) had compensated cirrhosis, 58% (18/31) had previously received sofosbuvir, velpatasvir and voxilaprevir, and 42% (13/31) had previously received sofosbuvir and velpatasvir.
Od 31 vključenih bolnikov je bilo 74 % (23/31) moških, 81 % (25/31) belcev, 71 % (22/31) jih je imelo izhodiščni indeks telesne mase < 30 kg/m2, 48 % (15/31) jih je imelo kompenzirano cirozo, 58 % (18/31) jih je predhodno prejemalo sofosbuvir, velpatasvir in voksilaprevir in 42 % (13/31) jih je predhodno prejemalo sofosbuvir in velpatasvir.
However, a possible teratogenic effect was indicated in rabbits where an increase in total visceral malformations was seen in exposed animals at AUC exposures up to 0.5 fold the human exposure at recommended clinical dose.
Vendar pa je bil nakazan morebiten teratogeni učinek pri kuncih, kjer je bilo pri izpostavljenih živalih z do 0,5-kratno izpostavljenostjo na podlagi AUC kot pri človeški izpostavljenosti pri priporočenem kliničnem odmerku opaženo zvečanje celokupnega števila visceralnih malformacij.
Vosevi is a medicine that contains the active substances sofosbuvir, velpatasvir and voxilaprevir in a single tablet.
Zdravilo Vosevi je zdravilo, ki vsebuje učinkovine sofosbuvir, velpatasvir in voksilaprevir v eni sami tableti.
• If you notice within 18 hours of the time you usually take Vosevi, you must take the tablet as soon as possible.
• Če se tega spomnite v roku 18 ur od takrat, ko običajno vzamete zdravilo Vosevi, morate tableto vzeti takoj, ko je mogoče.
The adverse reactions are listed below by system organ class and frequency.
V nadaljevanju so navedeni neželeni učinki po organskih sistemih in pogostnosti.
Other medicines and Vosevi
Druga zdravila in zdravilo Vosevi
c. Data from various strains of full length NS5A replicons or chimeric NS5A replicons carrying full-length NS5A genes that contain L31 or M31 polymorphisms.
c. Podatki iz različnih sevov replikonov NS5A polne dolžine ali himeričnih replikonov NS5A, ki vsebujejo gene NS5A polne dolžine, ki vsebujejo polimorfizme L31 ali M31.
Mean ratio (90% confidence interval)a,b Recommendation concerning co-administration with Vosevi
Povprečno razmerje (90-odstotni interval zaupanja)a, b
↑ Voxilaprevir
↑ Voksilaprevir
• modafinil, used to treat sleep disorders;
• modafinil, ki se uporablja za zdravljenje motenj spanja;
Most subjects had genotype 1 (61% (19/31) [1a, 48% (15/31); 1b, 13% (4/31)]) or genotype 3 (26% (8/31)) HCV infection.
Večina oseb je imela okužbo s HCV genotipa 1 (61 % (19/31) [1a, 48 % (15/31); 1b, 13 % (4/31)]) ali genotipa 3 (26 % (8/31)).
Famotidine dosed 12 hours prior to Vosevi
Famotidin uporabljen 12 ur pred zdravilom Vosevi
• atazanavir, efavirenz or lopinavir, used to treat HIV infection;
• atazanavir, efavirenz ali lopinavir, ki se uporabljajo se za zdravljenje okužbe z virusom HIV;
Dabigatran etexilate (P-gp substrate) and rosuvastatin (OATP1B and BCRP substrate) are contraindicated (see section 4.3 and Table 2).
Dabigatran eteksilat (substrat P-gp) in rosuvastatin (substrat OATP1B in BCRP) sta kontraindicirana (glejte poglavje 4.3 in preglednico 2).
Velpatasvir was not carcinogenic in the 26-week transgenic mouse and 2-year rat carcinogenicity studies at exposures up to 67- and 5-times higher than human exposure, respectively.
Velpatasvir ni bil kancerogen v 26-tedenski študiji pri transgenskih miših in 2-letni študiji kancerogenosti pri podganah ob izpostavljenostih, ki so bile do 67-krat in 5-krat večje od izpostavljenosti pri človeku.
In the Phase 3 trials increases in total bilirubin less than or equal to 1.5 x the upper limit of normal were observed in 4% of patients without cirrhosis and 10% of patients with compensated cirrhosis, due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir.
Celokupni bilirubin V preskušanjih faze 3 so opazili povečanja celokupnega bilirubina za 1,5 x zgornje meje normalne vrednosti ali manj pri 4 % bolnikov brez ciroze in 10 % pri bolnikih s kompenzirano cirozo, ker voksilaprevir zavira OATP1B1 in OATP1B3.
Concomitant use with ethinylestradiol-containing medicinal products may increase the risk of alanine aminotransferase (ALT) elevations and is contraindicated (see section 4.3 and Table 2).
Sočasna uporaba z zdravili, ki vsebujejo etinilestradiol, lahko poveča tveganje za zvišanje vrednosti alanin aminotransferaze (ALT), zato je kontraindicirana (glejte poglavje 4.3 in preglednico 2).
If you accidentally take more than the recommended dose of Vosevi you may be at increased risk of side effects with this medicine (see section 4 Possible side effects).
Če ste vzeli večji odmerek zdravila Vosevi, kot bi smeli Če ste pomotoma vzeli večji odmerek zdravila Vosevi od priporočenega, lahko pri vas obstaja večje tveganje za neželene učinke, povezane s tem zdravilom (glejte poglavje 4, Neželeni učinki).
Vitamin K antagonists (Liver function changes during treatment with Vosevi).
Antagonisti vitamina K (med zdravljenjem z zdravilom Vosevi prihaja do sprememb delovanja jeter)
The tablets are packed in plastic bottles with child resistant caps.
Tablete so pakirane v plastenke z za otroke varno zaporko.
When administered to lactating rats, voxilaprevir was detected in the plasma of nursing pups.
Pri dajanju doječim podganam so voksilaprevir zaznali v plazmi dojenih mladičev.
The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Na farmakokinetiko zdravil, ki se presnavljajo prek jeter (npr. imunosupresivna zdravila, kot so zaviralci kalcinevrina), lahko vplivajo spremembe delovanja jeter med zdravljenjem z DAA, ki so povezane z odstranitvijo virusa HCV.