FrancophonIA/ELRC3.0 huggingface dataset:
English: - Try to take OLYSIO at the same time each day.
Slovenian: - Zdravilo OLYSIO poskušajte jemati vsak dan ob istem času.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in v vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o
English: 24 weeks N = 31
Slovenian: 24 tednov n = 31
English: X represents multiple amino acids.
Slovenian: X predstavlja več aminokislin.
English: Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80,
Slovenian: Substitucije, ki so jih opažali samo v kombinacijah z drugimi novimi substitucijami na enem ali več položajih NS3: 80,
English: Treatment duration
Slovenian: Trajanje zdravljenja
English: OLYSIO must not be used in children and adolescents (under 18 years of age) because it has not been studied in this age group.
Slovenian: Zdravila OLYSIO se ne sme uporabljati pri otrocih in mladostnikih (mlajših od 18 let), ker pri tej starostni skupini njegova uporaba ni raziskana.
English: This is important because it is not known whether simeprevir can pass into breast milk.
Slovenian: To je pomembno zato, ker ni znano, ali simeprevir lahko prehaja v materino mleko ali ne.
English: Patients with these combinations are also included in other rows describing the individual substitutions.
Slovenian: Bolniki z navedenimi kombinacijami so šteti tudi v drugih vrsticah, v katerih so navedene samostojne substitucije.
English: If you do, your medicine may not work properly.
Slovenian: Če zdravljenje prekinete, zdravilo morda ne bo ustrezno delovalo.
English: pruritus*, photosensitivity photosensitivity reaction*
Slovenian: fotosenzitivnostna fotosenzitivnostna reakcija*
English: Warnings and precautions
Slovenian: Opozorila in previdnosti ukrepi
English: The mechanism is not established.
Slovenian: Mehanizem tega pojava ni pojasnjen.
English: There were no grade 3 events reported.
Slovenian: O primerih stopnje 3 niso poročali.
English: - Always take OLYSIO with food.
Slovenian: - Zdravilo OLYSIO vedno vzemite skupaj s hrano.
English: Do not take OLYSIO if you are allergic to simeprevir or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila OLYSIO, če ste alergični na simeprevir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: There are no adequate and well-controlled studies with simeprevir in pregnant women.
Slovenian: Pri nosečnicah niso opravili primernih in dobro nadzorovanih študij s simeprevirjem.
English: B-2340 Beerse Belgium
Slovenian: B-2340 Beerse
English: Two patients had emerging single substitution I170T.
Slovenian: Pri dveh bolnikih je prišlo do enojne substitucije I170T.
English: HCV RNA
Slovenian: HCV RNK
English: EU/1/14/924/001 (7 capsules)
Slovenian: EU/1/14/924/001 (7 kapsul) EU/1/14/924/002 (28 kapsul)
English: You and your partner must use an effective method of contraception during treatment and for several months afterwards.
Slovenian: Vi in vaš partner morata med zdravljenjem in še nekaj mesecev po zaključku zdravljenja uporabljati učinkovito metodo kontracepcije.
English: OLYSIO contains lactose (a type of sugar).
Slovenian: Zdravilo OLYSIO vsebuje laktozo (vrsto sladkorja).
English: Increase in sofosbuvir exposure observed in the pharmacokinetic substudy is not clinically relevant.
Slovenian: Povečanje izpostavljenosti sofosbuvirju, ki so ga opažali v farmakokinetični podštudiji, ni klinično pomembno.
English: Although causality is difficult to establish due to background advanced liver disease, a potential risk cannot be excluded.
Slovenian: Vzročno povezavo je težko ugotoviti zaradi osnovne napredovale jetrne bolezni, kljub temu morebitnega tveganja ne moremo izključiti.
English: Number of patients enrolled
Slovenian: Število vključenih bolnikov
English: The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti: 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),
English: OLYSIO should only be used during pregnancy or in women of childbearing potential if the benefit justifies the risk.
Slovenian: Zdravilo OLYSIO se lahko uporablja med nosečnostjo ali pri ženskah v rodnem obdobje le, kadar koristi opravičujejo tveganja.
English: Study C206
Slovenian: Študija C206
English: This medicinal product may pose a risk to the environment (see section 5.3).
Slovenian: To zdravilo lahko predstavlja tveganje za okolje (glejte poglavje 5.3).
English: Persistence of resistance-associated substitutions
Slovenian: Trajnost substitucij, ki so povezane z odpornostjo
English: What OLYSIO is and what it is used for
Slovenian: Kaj je zdravilo OLYSIO in za kaj ga uporabljamo
English: This is because OLYSIO and other medicines may interact with each other.
Slovenian: Zdravilo OLYSIO in druga zdravila lahko vplivajo druga na drugo.
English: This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite
Slovenian: To je posebej značilno, če se ob tem pojavi kateri od naslednjih simptomov: - siljenje na bruhanje (nauzea), bruhanje ali izguba apetita
English: In rodents, simeprevir elicited toxic effects in the liver, pancreas and gastrointestinal systems.
Slovenian: Pri glodalcih je simeprevir izzval toksične učinke na jetra, pankreas in gastrointestinalni sistem.
English: Cross-resistance is not expected between direct-acting antiviral agents with different mechanisms of action.
Slovenian: Navzkrižne odpornosti med zdravili z direktnim delovanjem na viruse z različnimi mehanizmi delovanja ni pričakovati.
English: What OLYSIO is and what it is used for What you need to know before you take OLYSIO
Slovenian: Kaj je zdravilo OLYSIO in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo OLYSIO
English: Simeprevir must be taken with food (see section 4.2).
Slovenian: Simeprevir je treba jemati s hrano (glejte poglavje 4.2).
English: Tell your doctor immediately if you are taking OLYSIO with sofosbuvir and any medicines for heart problems, and during treatment you experience:
Slovenian: Takoj obvestite zdravnika če jemljete zdravilo OLYSIO, sofosbuvir in katerokoli zdravilo za zdravljenje težav s srcem in se med zdravljenjem pojavijo:
English: Concentrations of digoxin should be monitored and used for titration of digoxin dose to obtain the desired clinical effect.
Slovenian: Koncentracije digoksina je treba spremljati in njihove vrednosti uporabiti za titriranje odmerka digoksina do želenega kliničnega učinka.
English: The presence of 50% human serum reduced simeprevir replicon activity by 2.4-fold.
Slovenian: Prisotnost 50% človeškega seruma je zmanjšala aktivnost simeprevirja proti replikonu za 2,4-krat.
English: C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces.
Slovenian: C označenega simeprevirja zdravim osebam so povprečno 91% celotne radioaktivnosti prestregli v blatu.
English: - Do not use this medicine after the expiry date which is stated on the carton and blister packaging after EXP.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem traku poleg oznake "EXP".
English: OLYSIO is available in packs containing 7 capsules (1 blister) or 28 capsules (4 blisters).
Slovenian: Zdravilo OLYSIO je na voljo v pakiranjih po 7 kapsul (1 pretisni trak) ali po 28 kapsul (4 pretisni
English: Especially avoid intense or prolonged exposure to sunlight (including tanning devices).
Slovenian: Izogibajte se zlasti intenzivnemu oziroma dolgotrajnemu sončenju (velja tudi za uporabo solarijev).
English: Excipient with known effect: each capsule contains 78.4 mg of lactose (as monohydrate).
Slovenian: Pomožne snovi z znanim učinkom: ena kapsula vsebuje 78,4 mg laktoze (v obliki laktoze
English: The majority of the adverse reactions reported were grade 1 in severity.
Slovenian: Večina poročanih neželenih učinkov je bila stopnje jakosti 1.
English: Other medicines and OLYSIO
Slovenian: Druga zdravila in zdravilo OLYSIO
English: 12 weeks OLYSIO + sofosbuvir (without ribavirin) may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see sections 4.4 and 5.1)
Slovenian: 12 tednov OLYSIO + sofosbuvir (brez ribavirina) se lahko pretehta pri bolnikih z ocenjenim majhnim tveganjem za klinično napredovanje bolezni in možnostmi za kasnejše ponovno zdravljenje (glejte poglavji 4.4 in 5.1)
English: OLYSIO capsules contain lactose monohydrate.
Slovenian: Kapsule zdravila OLYSIO vsebujejo laktozo monohidrat.
English: * darunavir/ritonavir + 50 mg simeprevir compared to
Slovenian: * darunavir/ritonavir + 50 mg simeprevirja v primerjavi
English: Simeprevir is extensively bound to plasma proteins ( 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein.
Slovenian: Simeprevir se močno veže na beljakovine v plazmi (> 99,9%), največ na albumin in manj na alfa-1-kisli glikoprotein.
English: If you take more OLYSIO than you should If you take more OLYSIO than you should, talk to your doctor or pharmacist immediately.
Slovenian: Če ste vzeli večji odmerek zdravila OLYSIO, kot bi smeli Če ste vzeli več zdravila OLYSIO, kot bi smeli, takoj obvestite zdravnika ali farmacevta.
English: Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals, ATC code: J05AE14.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, protivirusna zdravila z neposrednim delovanjem, oznaka ATC: J05AE14
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from OLYSIO therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom OLYSIO, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: It acts against the virus that causes hepatitis C infection, called ‘hepatitis C virus' (HCV).
Slovenian: Deluje proti virusu, ki povzroča hepatitis C in ga imenujemo virus hepatitisa C (HCV).
English: What you need to know before you take OLYSIO
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo OLYSIO
English: Steady-state was reached after 7 days of once daily dosing.
Slovenian: Do stanja dinamičnega ravnovesja je prišlo po 7 dneh odmerjanja enkrat na dan.
English: - OLYSIO must not be used by itself.
Slovenian: - Zdravila OLYSIO se ne sme uporabljati samostojno.
English: Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Slovenian: Simeprevir je opredeljen kot snov, ki izpolnjuje kriterije PBT (je obstojen, bioakumulativen in strupen) (glejte poglavje 6.6).
English: * In a clinical study in Asian patients from China and South-Korea, increased blood ‘bilirubin' levels were reported in more than 1 in 10 people (very common).
Slovenian: * V klinični študiji pri bolnikih azijskega porekla s Kitajske in Južne Koreje so poročali o zvečani koncentraciji bilirubina v krvi pri več kot 1 od 10 bolnikov (zelo pogosto).
English: Pregnant women should not take OLYSIO unless specifically directed by the doctor.
Slovenian: Nosečnice ne smejo jemati zdravila OLYSIO, razen če se je tako odločil zdravnik.
English: Do not stop taking OLYSIO unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila OLYSIO, razen če vam ta naroči zdravnik.
English: * Ketoconazole: pending further ATC classification.
Slovenian: * ketokonazol: oznaka ATC še ni dodeljena.
English: Eighty-eight percent (n = 93) of the patients were on HIV therapy, most commonly with 2 NRTIs + raltegravir.
Slovenian: Oseminosemdeset odstotkov (n = 93) bolnikov se je zdravilo zaradi okužbe s HIV, najpogosteje z dvema NRTI + raltegravirjem.
English: Patient individualised dose at the discretion of the physician, according to local clinical practice.
Slovenian: Odmerek, prilagojen posameznemu bolniku po presoji zdravnika glede na lokalne klinične smernice.
English: The efficacy of OLYSIO has not been studied in patients with HCV genotypes 2, 3, 5 or 6; therefore OLYSIO should not be used in these patients (see section 5.1).
Slovenian: Učinkovitosti zdravila OLYSIO niso preučevali pri bolnikih s HCV genotipa 2, 3, 5 ali 6, zato se zdravila OLYSIO pri teh bolnikih ne sme uporabljati (glejte poglavje 5.1).
English: This is due to potential liver function changes during treatment with OLYSIO.
Slovenian: Razlog za to so možne spremembe delovanja jeter pri zdravljenju z zdravilom OLYSIO.
English: The terminal elimination half-life of simeprevir was 10 to 13 hours in healthy subjects and 41 hours in HCV infected patients receiving 200 mg simeprevir.
Slovenian: Končni razpolovni čas izločanja simeprevirja je 10 do 13 ur pri zdravih osebah in 41 ur pri bolnikih, okuženih s HCV, ki prejemajo odmerek 200 mg simeprevirja.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with simeprevir in one or more subsets of the paediatric population from 3 years to less than 18 years of age in the treatment of chronic viral 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 simeprevirjem za eno ali več podskupin pediatrične populacije pri preiskovancih, ki so stari od 3 do manj kot 18 let za zdravljenje kroničnega virusnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Recommended duration of treatment provided that patient does not meet a stopping rule (see table 3).
Slovenian: Priporočeno trajanje zdravljenja, pod pogojem, da bolnik ne doseže smernic za ukinitev zdravljenja (glejte
English: Study HPC3021 N = 40 % (n/N)
Slovenian: študija HPC3021 N = 40 % (n/N)
English: Metabolites identified in faeces were formed via oxidation at the macrocyclic moiety or aromatic moiety or both and by O-demethylation followed by oxidation.
Slovenian: Metaboliti, ki so jih odkrili v blatu, so nastali z oksidacijo na makrociklični ali aromatski skupini ali na obeh in z O-demetilacijo, ki ji sledi oksidacija.
English: No dose adjustment is necessary based on body weight or body mass index.
Slovenian: Prilagajanje odmerkov na podlagi telesne mase ali indeksa telesne mase ni potrebno.
English: Unchanged simeprevir in faeces accounted for on average 31% of the administered dose.
Slovenian: Nespremenjeni simeprevir v blatu je predstavljal povprečno 31% danega odmerka.
English: The 63 enrolled patients had a median age of 51 years (range 24 to 68 years; with 2% above 65 years); 54% were male; 43% had a
Slovenian: 63 vključenih bolnikov je imelo mediano starost 51 let (razpon 24 do 68 let; z 2% starejših od 65 let); 54% je bilo moških; 43%
English: There were no grade 3 or 4 photosensitivity reactions reported and none of the patients discontinued treatment due to photosensitivity reactions.
Slovenian: O fotosenzitivnih reakcijah stopnje 3 ali 4 niso poročali in noben bolnik zdravljenja ni prekinil zaradi fotosenzitivnih reakcij.
English: The doctor will advise you to stop breast-feeding or to stop taking OLYSIO while breast-feeding.
Slovenian: Zdravnik vam bo svetoval, da prenehate dojiti ali pa prenehate jemati zdravilo OLYSIO, dokler dojite.
English: C-simeprevir to healthy subjects, the majority of the radioactivity in plasma (up to 98%) was accounted for by unchanged drug and a small part of the radioactivity in plasma was related to metabolites (none being major metabolites).
Slovenian: C označenega simeprevirja zdravim osebam je bilo večino (do 98%) radioaktivnosti v plazmi mogoče pripisati nespremenjeni učinkovini, le majhen del radioaktivnosti v plazmi pa izvira iz presnovkov (pri čemer nobeden od njih ni glavni presnovek).
English: Patients with mild to moderate rashes should be monitored for possible progression of rash, including the development of mucosal signs or systemic symptoms.
Slovenian: Bolnike z blagim do zmernim izpuščajem je treba spremljati glede pojava napredovanja izpuščaja, vključno z razvojem znakov na sluznici ali sistemskih simptomov.
English: Do not stop taking OLYSIO
Slovenian: Ne prenehajte jemati zdravila OLYSIO
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with OLYSIO, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Slovenian: Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom OLYSIO, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
English: In pregnant rats, simeprevir concentrations in placenta, fetal liver and foetus were lower compared to those observed in blood.
Slovenian: Pri brejih podganah je bila koncentracija simeprevirja v placenti, plodovih jetrih in plodu nižja od koncentracije v krvi.
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in
Slovenian: Bolnike, z velikom tveganjem za pojav bradikardije je treba 48 ur neprekinjeno spremljati v ustreznem kliničnem okolju.
English: Tell your doctor if any of the following applies: - you currently take, or have taken in the last few months, the medicine amiodarone (your doctor may consider alternative treatments if you have taken this medicine) - you take other medicines to treat irregular heart beat or high blood pressure.
Slovenian: - trenutno jemljete ali ste v zadnjih mesecih jemali amiodaron (če ste jamali to zdravilo, bo vaš zdravnik razmislil o drugih možnostih zdravljenja) - jemljete druga zdravila za zdravljenje motenj srčnega ritma ali visokega krvnega tlaka.
English: Disposal: Read the package leaflet.
Slovenian: Odstranjevanje: glejte navodilo za uporabo.
English: Studies in animals have shown reproductive effects (see section 5.3).
Slovenian: Rezultati študij pri živalih kažejo učinke na sposobnost razmnoževanja (glejte poglavje 5.3).
English: The pharmacokinetics of simeprevir in children aged below 18 years have not been investigated.
Slovenian: Farmakokinetike simeprevirja niso raziskovali pri otrocih, mlajših od 18 let.
English: As liver function may change during treatment with OLYSIO, close monitoring of International Normalised Ratio (INR) values is recommended.
Slovenian: Ker se delovanje jeter v času zdravljenja z zdravilom OLYSIO lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR).
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e., treatment stopping rules) are presented in table 3.
Slovenian: Pražne koncentracije HCV RNK, pri katerih je treba zdravljenje ukiniti, (tj. smernice za ukinitev zdravljenja), so prikazane v preglednici 3.
English: Read all of this leaflet carefully before you start taking this medicine because it contains
Slovenian: Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne
English: Simeprevir is a specific inhibitor of the HCV NS3/4A serine protease, which is essential for viral replication.
Slovenian: Simeprevir je specifičen zaviralec serinske proteaze HCV NS3/4A, ki je bistvena za replikacijo virusov.
English: OLYSIO must be taken orally once a day with food (see section 5.2).
Slovenian: Zdravilo OLYSIO je treba jemati peroralno enkrat na dan, skupaj s hrano (glejte poglavje 5.2).
English: White gelatin capsule of approximately 22 mm in length, marked with “TMC435 150” in black ink.
Slovenian: Bela želatinska kapsula dolžine približno 22 mm z oznako "TMC435 150", natisnjeno s črnim
English: If the capsule shell is indented or bent - without being broken or opened - the capsule can still
Slovenian: Če pa je kapsula vdrta ali zmečkana, ni pa zlomljena ali odprta, kapsulo lahko uporabite.
English: In the pooled phase 3 safety data, the majority of the adverse reactions reported during 12 weeks treatment with simeprevir were grade 1 to 2 in severity.
Slovenian: V bazi združenih podatkov o varnosti študij faze 3 je večina neželenih učinkov, poročanih v 12 tednih zdravljenja s simeprevirjem, dosegla stopnjo jakosti 1 do 2.
English: This interaction study has been performed with a dose higher than the recommended dose for simeprevir assessing the maximal effect on the co-administered drug.
Slovenian: V tej interakcijski študiji so uporabljali večji odmerek simeprevirja od priporočenega, da bi lahko ocenili največji učinek na sočasno uporabljano zdravilo.
English: Treatment with OLYSIO should be initiated and monitored by a physician experienced in the
Slovenian: Zdravljenje z zdravilom OLYSIO mora uvesti in spremljati zdravnik z izkušnjami pri zdravljenju
English: Compared to intake without food, administration of simeprevir with food to healthy subjects increased the AUC by 61% after a high-fat, high-caloric (928 kcal) and 69% after a normal caloric (533 kcal) breakfast, and delayed the absorption by 1 hour and 1.5 hours, respectively.
Slovenian: V primerjavi z vnosom zdravila brez hrane je pri zdravih osebah odmerjanje simeprevirja skupaj s hrano povečalo AUC za 61% po zaužitju zelo kaloričnega zajtrka (928 kcal) z veliko vsebnostjo maščob, za 69% pa po zaužitju zajtrka z normalnim številom kalorij (533 kcal), pri čemer je prišlo do zakasnitve absorpcije za 1 uro oziroma za 1, 5 ure.
English: Ελλάδα
Slovenian: Po enkratnem
English: Due to the long elimination 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 OLYSIO combination treatment with sofosbuvir.
Slovenian: Zaradi dolgega razpolovnega časa izločanja amiodarona, je potrebno tudi ustrezno spremljanje bolnikov, ki so v preteklih mesecih prenehali jemati amiodaron in bodo začeli s kombiniranim zdravljenjem z zdravilom OLYSIO in sofosbuvirjem.
English: Interaction studies have been performed in healthy adults with the recommended dose of 150 mg simeprevir once daily unless otherwise noted.
Slovenian: Interakcijske študije so izvajali pri zdravih odraslih s priporočenim odmerkom 150 mg simeprevirja enkrat na dan, kjer ni navedeno drugače.
English: peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin); SMV = simeprevir.
Slovenian: peg-IFN-alfa = peginterferon alfa; RBV = ribavirin (odmerjanje ribavirina glede na telesno maso, dvakrat na dan, v skladu s povzetkom glavnih značilnosti zdravila za ribavirin); SMV = simeprevir.
English: Table 4: Interactions and dose recommendation with other medicinal products Recommendation for co-administration
Slovenian: Preglednica 4: Interakcije in priporočila za odmerjanje z drugimi zdravili
English: Female patients of childbearing potential must use an effective form of contraception (see section 4.6).
Slovenian: Bolnice v rodnem obdobju morajo uporabljati učinkovito obliko kontracepcije (glejte poglavje 4.6).
English: 150 mg simeprevir 12 weeks % (n/N)
Slovenian: 150 mg simeprevir 12 tednov % (n/N)