natgillin/translations-raw huggingface dataset:
The company's analysis was intended to show that diabetic patients with peripheral neuropathic pain not caused by diabetes have as good outcomes with Qutenza as non-diabetic patients.
Namen analize, ki jo je opravila družba, je bil dokazati, da imajo sladkorni bolniki s periferno nevropatsko boleznijo, ki ni posledica sladkorne bolezni, enako dobre rezultate z zdravilom Qutenza kot bolniki brez sladkorne bolezni.
What is happening with Qutenza for the treatment of neuropathic pain in patients who do not have diabetes?
Kakšne so posledice za zdravilo Qutenza, indicirano za zdravljenje nevropatske bolečine pri bolnikih, ki nimajo sladkorne bolezni?
How is Qutenza expected to work?
Kako naj bi zdravilo Qutenza delovalo?
Qutenza was also expected to be used in patients with diabetes who have peripheral neuropathic pain not caused by their diabetes.
Zdravilo Qutenza naj bi se uporabljalo tudi za zdravljenje bolnikov s sladkorno boleznijo, pri katerih se pojavi periferna nevropatska bolečina, ki ni posledica sladkorne bolezni.
Qutenza is a cutaneous patch (a patch that delivers a medicine to the skin).
Qutenza je dermalni obliž (obliž, ki dovaja zdravilo na kožo).
The frequency of these events is unknown.
Pogostnost teh dogodkov je neznana.
• Anaemia (low number of red blood cells).
• anemija (majhno število rdečih krvnih celic).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15.01.2015
Main demographics in TURQUOISE-III Characteristics
Glavne demografske značilnosti v TURQUOISE-III
Component of a multipack, can't be sold separately.
Komponenta večkratnega pakiranja, ni za ločeno prodajo.
(administered 12 hours apart)
(uporabljena v razmaku 12 ur)
MARKETING AUTHORISATION NUMBER(S) EU/1/14/982/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/982/001
Table 15 shows SVR rates for these subjects.
Preglednica 15 prikazuje deleže SVR za te preiskovance.
Limited data in patients with endstage renal disease indicate no clinically significant changes in exposure also in this patient group.
Omejeni podatki pri bolnikih z ledvično odpovedjo ne kažejo nobenih klinično pomembnih sprememb pri izpostavitvi tudi pri tej skupini bolnikov.
PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 14 filmsko obloženih tablet
• Feeling weak or lack of energy (asthenia).
• občutek šibkosti ali pomanjkanja energije (astenija).
Arm B 24 Weeks N = 32
Skupina B 24 tednov N = 32
Treatment-emergent variants and their prevalence in these virologic failure populations are shown in Table 5.
Med zdravljenjem nastale variante in njihova prevalenca v teh populacijah z virološkim neuspehom so prikazane v preglednici 5.
See section 5.1 for additional information.
Za dodatne informacije glejte poglavje 5.1.
If you accidentally take more than the recommended dose, you should contact your doctor or go to the nearest hospital straight away.
Če ste pomotoma vzeli večji odmerek od priporočenega, takoj obvestite svojega zdravnika ali pojdite v najbližjo bolnišnico.
Genotype 1a N=67
Genotip 1a N = 67
• Monitor for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
• kontrola glede kliničnih znakov in simptomov dekompenzacije jeter (kot so ascites, jetrna encefalopatija, krvavitev iz varic),
The combined action of the three active substances stops the hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time.
Kombinirano delovanje treh zdravilnih učinkovin ustavi razmnoževanje virusa hepatitisa C in okužbo novih celic ter v določenem časovnem obdobju odstrani virus iz krvi.
A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would results in <10% change in ombitasvir exposures, and no change in paritaprevir exposures.
Sprememba telesne mase za10 kg od 76 kg (mediana telesna masa v študijah 3. faze) bi imela za posledico < 10 % spremembo izpostavljenosti ombitasvirju in nobene spremembe izpostavljenosti paritaprevirju.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljenje na spletni strain Evropske agencije za zdravila: http://www.ema.europa.eu.
• If you have severe liver problems other than hepatitis C.
• Če imate hudo bolezen jeter, ki ni hepatitis C.
Effect of baseline HCV substitutions/polymorphisms on treatment outcome
Vpliv izhodiščnih substitucij/polimorfizmov HCV na izid zdravljenja
Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AX67
Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse, oznaka ATC: J05AX67
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Preobčutljivost na zdravilne učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
• Discontinue treatment in patients who develop evidence of hepatic decompensation.
• prekiniti zdravljenje pri bolnikih, pri katerih so se pojavili znaki dekompenzacije jeter.
25 mg once daily administered in the morning, with food
25 mg enkrat na dan, zjutraj s hrano
AbbVie Ltd Maidenhead SL6 4UB United Kingdom
AbbVie Ltd Maidenhead SL6 4UB Velika Britanija
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Viekirax.
Če kar koli od zgoraj navedenega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdraviloViekirax.
Contraceptive medicines that contain ethinyl estradiol cannot be used in combination with Viekirax.
Zdravila za kontracepcijo, ki vsebujejo etinilestradiol, se ne smejo uporabljati v kombinaciji z zdravilom Viekirax.
If you take more Viekirax than you should
Če ste vzeli večji odmerek zdravila Viekirax, kot bi smeli
Coadministration of Viekirax with other antivirals has not been studied and therefore cannot be recommended.
Sočasna uporaba zdravila Viekirax z drugimi protivirusnimi zdravili ni bila raziskana in je zato ni mogoče priporočati.
Purpose of the medicine
Namen uporabe zdravila
HIV-1 Co-infection
Sočasna okužba s HIV-1
If you forget to take Viekirax
Če ste pozabili vzeti zdravilo Viekirax
Follow the dosing recommendations in Table 1.
Upoštevajte navodila za odmerjanje v preglednici 1.
NA Clinical monitoring of patients is recommended.
NA Bolnike je priporočljivo klinično nadzirati.
The assay had a lower limit of quantification (LLOQ) of 25 IU per mL.
Preizkus je imel spodnjo mejo kvantifikacije (LLOQ) 25 i.e. na ml.
Viekirax is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Zdravilo Viekirax je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C (nalezljiva bolezen, ki prizadane jetra in jo povzroča virus hepatitisa C).
How much to take The recommended dose is two tablets taken together in the morning.
Priporočeni odmerek je dve tableti, ki ju vzamete zjutraj.
If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is therefore not recommended.
Če je dodan zaviralec proteaze HIV (atazanavir, darunavir), se lahko izpostavljenost rilpivirinu še dodatno poveča, zato takšna uporaba ni priporočljiva.
Obligation to conduct post-authorisation measures
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
These ALT elevations were significantly more frequent in the subgroup of subjects who were using ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (6 of 25 subjects); (see section 4.3).
Ta zvišanja ALT so bila bistveno pogostejša v podskupini preiskovank, ki so uporabljale zdravila z etinilestradiolom, na primer kombinirane peroralne kontraceptive ali kontracepcijske vaginalne obročke (6 od 25 oseb); (glejte poglavje 4.3).
It is important not to miss a dose of this medicine.
Pomembno je, da ne pozabite vzeti tega zdravila.
The dose of ribavirin was left to the discretion of the investigator, with most patients receiving 600 to 800 mg per day as a starting dose, and most patients also receiving 600 to 800 mg per day at the end of treatment.
Odmerek ribavirina je bil prepuščen raziskovalčevi presoji; večina bolnikov je kot začetni odmerek prejemala od 600 do 800 mg na dan in večina bolnikov je tudi na koncu zdravljenja prejemala od 600 do
Yes (for all three parameters listed above) No (for any parameter listed above) *AFP= serum alpha fetoprotein
Ne (za kateri koli zgoraj našteti parameter) *AFP= alfa fetoprotein v serumu
Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, coadministered with a backbone of tenofovir plus emtricitabine or lamivudine.
Preiskovanci so prejemali stabilno shemo antiretrovirusne terapije (ART) za HIV-1, ki je vključevala z ritonavirjem okrepljen atazanavir ali raltegravir, uporabljen z osnovno shemo tenofovirja ter emtricitabina ali lamivudina.
SVR12, n/N (%) [95% CI] Outcome for subjects without SVR12 On-treatment virologic failure Post-treatment relapse
SVR12, n/N (%) [95 % IZ] Izid pri preiskovancih brez SVR12 Virološki neuspeh med zdravljenjem Recidiv po zdravljenju a
In contrast, the rate of ALT elevations in subjects using other types of estrogens as typically used in hormonal replacement therapy (i.e., oral and topical estradiol and conjugated estrogens) was similar to the rate observed in subjects who were not using estrogencontaining products (approximately 1% in each group).
V nasprotju s tem so bila zvišanja ALT pri tistih, ki so uporabljale druge vrste estrogenov, kakršni se običajno uporabljajo pri hormonskem nadomestnem zdravljenju (tj. peroralni in lokalni estradiol in konjugirani estrogeni), podobna deležu, opaženem med neuporabnicami zdravil z estrogenom (približno 1 % v vsaki skupini).
The interactions between pitavastatin and fluvastatin and Viekirax have not been investigated.
Medsebojna delovanja med pitavastatinom in fluvastatinom ter zdravilom Viekirax niso raziskana.
Three interrupted Viekirax and dasabuvir for one to seven days, including one on ethinylestradiol.
Tri osebe so jemanje zdravila Viekirax in dasabuvirja prekinile za obdobje od enega do sedmih dni; ena od njih je dobivala etinilestradiol.
(see sections 4.2, 4.4, and
(glejte poglavje 4.4).
INFORMATION IN BRAILLE viekirax
PODATKI V BRAILLOVI PISAVI viekirax
Concerning genotypespecific virological and clinical activity, see section 5.1.
Za virološko in klinično aktivnost, specifično za genotip, glejte poglavje 5.1.
Number of Responders at the End of Treatment AFP* < 20 ng/mL, platelets ≥ 90 x 109/L, AND albumin ≥ 35 g/L prior to treatment
AFP* < 20 ng/ml, trombociti ≥ 90 x 109/l, IN albumin ≥ 35 g/l pred zdravljenjem
As the incidence of such elevations was 26% among women taking a concomitant ethinylestradiol-containing medicinal product, such medicinal products are contraindicated with Viekirax with or without dasabuvir.
Ker je bila incidenca takšnih zvišanj med ženskami, ki so sočasno jemale zdravila z etinilestradiolom, 26 %, so takšna zdravila kontraindicirana med uporabo zdravila Viekirax z dasabuvirjem ali brez njega.
Ombitasvir is an inhibitor of HCV NS5A which is essential for viral replication.
Ombitasvir je zaviralec beljakovine NS5A HCV, ki je nujna za replikacijo virusov.
In the presence of paritaprevir/ritonavir, dasabuvir exposures decreased by approximately 50% to 60% while ombitasvir exposures increased by 31-47%.
V prisotnosti paritaprevirja/ritonavirja se je izpostavljenost dasabuvirju zmanjšala za približno 50 do 60 %, izpostavljenost ombitasvirju pa se je povečala za 31 do 47 %.
b. Other includes early drug discontinuation not due to virologic failure missing HCV RNA values in the
b. "Drugo" vključuje zgodnjo ukinitev zdravila, ki ni posledica virološkega neuspeha in manjkajoče vrednosti HCV RNA znotraj okna SVR12.
Given the low virologic failure rates observed with recommended treatment regimens for HCV genotype 1a- and 1b-infected subjects, the presence of baseline variants appears to have little impact on the likelihood of achieving SVR.
Glede na majhen delež neuspešnega zdravljenja, zabeležen ob uporabi priporočenih shem zdravljenja pri bolnikih, okuženih s HCV genotipa 1a in 1b, prisotnost izhodiščnih variant le malo vpliva na verjetnost za doseganje trajnega virološkega odziva (SVR).
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis
Tveganje za dekompenzacijo jeter in okvaro jeter pri bolnikih s cirozo
TURQUOISE-II: Relapse Rates by Baseline Laboratory Values after 12 and 24 Weeks of Treatment in Subjects with Genotype 1a Infection and Compensated Cirrhosis
TURQUOISE-II: Deleži recidivov glede na izhodiščne laboratorijske vrednosti, po 12 in 24 tednih zdravljenja, pri preiskovancih s kompenzirano cirozo, okuženih z genotipom 1a
Thirty four subjects (29 with HCV genotype 1a infection and 5 with HCV genotype 1b infection) were enrolled who had not received treatment for HCV infection after transplantation and had a METAVIR fibrosis score of F2 or less.
Vključenih je bilo štiriintrideset preiskovancev (29 z okužbo s HCV genotipa 1a in 5 z okužbo s HCV genotipa 1b), ki po presaditvi niso bili zdravljeni zaradi okužbe s HCV in so imeli oceno fibroze po METAVIR F2 ali manj.
Patients with severe hepatic impairment (Child-Pugh C) (see section 5.2).
Bolniki s hudo okvaro jeter (Child-Pugh C) (glejte poglavje 5.2).
Effect of dasabuvir on paritaprevir/ritonavir and ombitasvir In the presence of dasabuvir, paritaprevir exposures increased by 50% to 65% while there was no change in ombitasvir exposures.
Vpliv dasabuvirja na paritaprevir/ritonavir in ombitasvir V prisotnosti dasabuvirja se je izpostavljenost paritaprevirju povečala za 50 do 65 %, izpostavljenost ombitasvirju pa se ni spremenila.
The efficacy and safety of Viekirax in combination with dasabuvir with and without ribavirin was evaluated in seven Phase 3 clinical trials, including two trials exclusively in subjects with cirrhosis (Child-Pugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Učinkovitost in varnost zdravila Viekirax v kombinaciji z dasabuvirjem (z ribavirinom ali brez njega) so preučili v sedmih kliničnih preskušanjih 3. faze (vključno z dvema preskušanjema izključno pri bolnikih s cirozo (Child-Pugh A)) pri več kot 2.360 preiskovancih s kronično okužbo s hepatitisom C genotipa 1, kot povzema preglednica 6.
It is not known whether the active substances in Viekirax (ombitasvir, paritaprevir and ritonavir) pass into breast milk.
Ni znano, ali zdravilne učinkovine v zdravilu Viekirax (ombitasvir, paritaprevir in ritonavir) prehajajo v materino mleko.
Purpose of the medicine alfuzosin for an enlarged prostate amiodarone, dronedarone used to correct irregular heartbeats astemizole, terfenadine for allergy symptoms.
Namen uporabe zdravila alfuzosin pri povečani prostati amiodaron, dronedaron za uravnavanje nerednega srčnega utripa astemizol, terfenadin pri simptomih alergije.
33 out of the 34 subjects (97.1%) achieved SVR12 (96.6% in subjects with genotype 1a infection and 100% in subjects with genotype 1b infection).
SVR 12 je doseglo 33 od 34 preiskovancev (97,1 %) (96,6 % okuženih z genotipom 1a in 100 % okuženih z genotipom 1b).
5 mg single dose and other vitamin K antagonists
Klinične opombe enkraten odmerek 5 mg in drugi antagonisti vitamina K
The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑ = increase (more than 20%), ↓ = decrease (of more than 20%), ↔ = no change or change less than 20%).
Smer puščice kaže smer spremembe izpostavljenosti (Cmax in AUC) paritaprevirju, ombitasvirju, dasabuvirju in sočasno uporabljenemu zdravilu (↑ = povečanje za več kot 20 %, ↓ = zmanjšanje za več kot
Available pharmacokinetic data in animals have shown excretion of active substance and metabolite in milk (see section 5.3).
Farmakokinetični podatki, ki so na voljo za živali, so pokazali izločanje zdravilne učinkovine in presnovka v mleko (glejte poglavje 5.3).
Darunavir, dosed 800 mg once daily, if administered at the same time as Viekirax and dasabuvir, can be used in the absence of extensive PI resistance (darunavir exposure lowered).
Darunavir v odmerku 800 mg enkrat na dan, če se ga da ob istem času kot zdravilo Viekirax in dasabuvir, se lahko uporablja, če ni obsežne odpornosti proti PI (zmanjšanje izpostavljenosti darunavirju).
Although buprenorphine and zolpidem are also metabolized by CYP3A, drug interaction studies indicate that no dose adjustment is needed when co-administering these medicinal products with Viekirax with or without dasabuvir (see Table 2).
Sicer se tudi buprenorfin in zolpidem presnavljata s CYP3A, vendar študije medsebojnega delovanja zdravil kažejo, da med sočasno uporabo teh zdravil z zdravilom Viekirax (z dasabuvirjem ali brez njega) odmerka ni treba prilagoditi (glejte preglednico 2).
Coadministration with ethinylestradiol may increase the risk of ALT elevations (see sections 4.3 and 4.4).
Sočasna uporaba z etinilestradiolom lahko poveča tveganje za zvišanje ALT (glejte poglavji 4.3 in 4.4).
No subjects experienced on-treatment virologic failure or relapse.
Pri nobenem preiskovancu se med zdravljenjem ni pojavil virološki neuspeh ali recidiv.
Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
COBAS TaqMan HCV test (verzija 2.0), ki je namenjen za uporabo s sistemom High Pure System.
In subjects receiving Viekirax and dasabuvir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
Pri preiskovancih, ki so prejemali zdravilo Viekirax in dasabuvir brez ribavirina, so bili neželeni učinki, ki so običajno povezani z ribavirinom (npr.navzea, insomnia, anemija), manj pogosti in noben preiskovanec (0/588) ni trajno prekinil zdravljenja zaradi neželenih učinkov.
Co-administration of Viekirax with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QT-prolongation comedications.
Sočasna uporaba zdravila Viekirax z rilpivirinom enkrat na dan pride v poštev le pri bolnikih brez znanega podaljšanja intervala QT, ki ob tem tudi ne uporabljajo kakšnih drugih zdravil, ki podaljšajo interval
Recommended co-administered medicinal product(s) and treatment duration for Viekirax by patient population
Priporočena sočasna zdravila in trajanje zdravljenja z zdravilom Viekirax glede na populacijo bolnikov
In the genotype 1b replicon, the activity of ombitasvir was reduced by less than 10-fold by variants at amino acid positions 30 and 31.
V replikonu genotipa 1b so variante na aminokislinskih mestih 30 in 31 zmanjšale aktivnost ombitasvirja za manj kot 10-krat.
Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing ombitasvir, paritaprevir, and dasabuvir with or without ribavirin (for 8, 12, or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
Od 2.510 oseb s HCV genotipa 1, zdravljenih s shemami, ki so vsebovale ombitasvir, paritaprevir in dasabuvir, z ribavirinom ali brez njega (v obdobju 8, 12 ali 24 tednov) v kliničnih preskušanjih faze 2b in 3, je virološki neuspeh (primarni recidiv po zdravljenju) doživelo skupno 74 (3 %).
You will take Viekirax for either 12 or 24 weeks.
Kako dolgo jemati zdravilo Viekirax Zdravilo Viekirax boste jemali bodisi 12 ali 24 tednov.
When starting coadministration with Viekirax, administer 0.5 mg tacrolimus once every week.
Na začetku sočasnega odmerjanja z zdravilom Viekirax uporabite 0,5 mg takrolimusa enkrat na teden.
Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see section 4.4 and 4.5).
Uporaba zdravil, ki vsebujejo etinilestradiol, npr. takšnih, ki so v večini kombiniranih peroralnih kontraceptivov ali kontracepcijskih vaginalnih obročkov (glejte poglavji 4.4 in 4.5).
Outcome for subjects without SVR12 On-treatment virologic failure Post-treatment relapse Other
Izid pri preiskovancih brez SVR12 Virološki neuspeh med zdravljenjem Recidiv po zdravljenju Drugo
For dosing recommendations with HIV antiviral agents, refer to section 4.4 (Treatment of patients with HIV co-infection) and section 4.5.
Za priporočila o odmerjanju s protivirusnimi zdravili proti HIV glejte poglavje 4.4 (Zdravljenje bolnikov, sočasno okuženih s HIV) in poglavje 4.5.
Viekirax and dasabuvir + ribavirin 12 or 24 weeks N = 380 n (%)
Viekirax in dasabuvir + ribavirin 12 ali 24 tednov N = 380 n (%)
Simvastatin, lovastatin and atorvastatin are contraindicated (see section 4.3 and 4.5).
Simvastatin, lovastatin in atorvastatin so kontraindicirani (glejte poglavji 4.3 in 4.5).
Not Studied.
Ni raziskano.
Coadministration with enzyme inducers may increase the risk of adverse events and ALT elevations (see Table 2).
Sočasna uporaba z induktorji encimov lahko poveča tveganje za neželene učinke in zvišanje ALT (glejte preglednico 2).
Indinavir Saquinavir Tipranavir
↑ paritaprevir indinavir sakvinavir tipranavir
Viekirax is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Zdravila Viekirax se ne priporoča pri bolnikih z zmerno okvaro jeter (Child-Pugh B).
4-24 mg/16 mg once daily
4-24 mg/1-6 mg enkrat na dan
Asthenia Fatigue *Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.
*Nabor podatkov obsega vse preiskovance, okužene z genotipom 1, vključene v preskušanja 2. in 3. faze, tudi preiskovance s cirozo.
CORAL-I: treatment-naïve or pegIFN + RBV-experienced, at least 12 months post liver transplant
CORAL-I: še nezdravljeni ali že zdravljeni s pegIFN + RBV, vsaj 12 mesecev po presaditvi jeter
In subjects who received the recommended regimen, 97% achieved SVR overall (among which 181 subjects with compensated cirrhosis achieved 97% SVR), while 0.5% experienced virologic breakthrough and 1.2% experienced post-treatment relapse.
preiskovancev s kompenzirano cirozo doseglo 97 % SVR), medtem ko se je pri 0,5 % pojavil virološki preboj, pri 1,2 % pa recidiv po zdravljenju.
Polyvinyl alcohol (E1203) Polyethylene glycol 3350 Talc (E553b) Titanium dioxide (E171) Iron oxide red (E172)
Filmska obloga: polivinilalkohol (E1203) polietilenglikol 3350 smukec (E553b) titanov dioksid (E171)
Ethinylestradiol is contraindicated in combination with Viekirax (see sections 4.3 and 4.4).
Etinilestradiol je kontraindiciran v kombinaciji z zdravilom Viekirax (glejte poglavji 4.3 in 4.4).
5 of 6 subjects with compensated cirrhosis in each arm achieved SVR12.
SVR12 je doseglo 5 od 6 preiskovancev s kompenzirano cirozo v vsaki skupini.
− Tablet film-coating: polyvinyl alcohol (E1203), polyethylene glycol 3350, talc (E553b), titanium dioxide (E171) and red iron oxide (E172).
− Filmska obloga tablete: polivinilalkohol (E1203), polietilenglikol 3350, smukec (E553b), titanov dioksid (E171), rdeči železov oksid (E172).
Patients who are taking ethinylestradiol-containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Viekirax and dasabuvir therapy (see sections 4.3 and 4.5).
Bolnice, ki uporabljajo zdravila z etinilestradiolom (takšna je večina kombiniranih peroralnih kontraceptivov ali kontracepcijskih vaginalnih obročkov), jih morajo prenehati uporabljati ali preiti na drugačen način kontracepcije (npr. na samo progestinsko kontracepcijo ali na nehormonske načine), preden začnejo zdravljenje z zdravilom Viekirax in dasabuvirjem (glejte poglavji 4.3 in 4.5).