FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Slovenian: Bolnice, ki jemljejo estrogene v okviru hormonske nadomestne terapije, je treba klinično spremljati, da ugotovite znake pomanjkanja estrogena.
English: CYP3A4 is partly responsible for the metabolism of telaprevir.
Slovenian: izoencim CYP3A4 je delno odgovoren za presnovo telaprevirja.
English: Telaprevir and its major metabolite are excreted in rat milk (see section 5.3).
Slovenian: Telaprevir in njegov glavni presnovek se izločata v mleko pri podganah (glejte poglavje 5.3).
English: Syncope and retinopathy have been reported in some patients taking INCIVO and should be considered when assessing a patient's ability to drive or operate machines.
Slovenian: Pri nekaterih bolnikih, ki so jemali zdravilo INCIVO, so poročali o sinkopi in retinopatiji, kar je treba upoštevati pri oceni bolnikove sposobnosti za vožnjo in upravljanje s stroji.
English: Marked immunosuppressant dose reductions with or without prolongation of the dosing intervals will be required.
Slovenian: Potrebno bo bistveno zmanjšanje odmerka z ali brez podaljšanje razmika med odmerki imunosupresiva.
English: If you or your female partner become pregnant during INCIVO treatment or the months that follow, you must contact your doctor immediately (see section 'Pregnancy precautions for men and women' below).
Slovenian: Če zanosite (oziroma če zanosi vaša partnerka) med zdravljenjem z zdravilom INCIVO ali v mesecih, ki sledijo temu zdravljenju, se nemudoma obrnite na svojega zdravnika (glejte poglavje Preprečevanje nosečnosti v nadaljevanju).
English: Co-administration with inducers may lead to lower exposure of telaprevir with risk of lower efficacy.
Slovenian: Sočasna uporaba z induktorji lahko vodi do zmanjšanja izpostavljenosti telaprevirju in nevarnosti za manjšo učinkovitost.
English: ANTIFUNGALS ketoconazole* itraconazole posaconazole voriconazole
Slovenian: ANTIMIKOTIKI ketokonazol* itrakonazol posakonazol vorikonazol
English: The contribution of unchanged
Slovenian: Prispevek nespremenjenega, s C
English: • Grading and management of rash and severe cutaneous reactions, particularly with respect to criteria for the continuation or discontinuation of telaprevir and the other treatment components.
Slovenian: • merila za oceno in zdravljenje izpuščaja in hudih kožnih reakcij, še posebno kriterije za nadaljevanje ali prekinitev zdravljenja s telaprevirjem in drugimi zdravili
English: Telaprevir is primarily metabolised in the liver.
Slovenian: Telaprevir se presnavlja predvsem v jetrih.
English: The mean elimination half-life after single-dose oral administration of telaprevir 750 mg typically ranged from about 4.0 to 4.7 hours.
Slovenian: Srednja vrednost razpolovne dobe izločanja po peroralnem jemanju enkratnega 750 mg odmerka telaprevirja se je značilno gibala med približno 4,0 in 4,7 ure.
English: Table 4: Selected laboratory abnormalities (DAIDS
Slovenian: Preglednica 4: izbrane laboratorijske nenormalnosti (stopnje ≥ 2 po DAIDS
English: Table 6: SVR rates for patient subgroups: Study C211 T12(b.i.d.
Slovenian: Preglednica 6: stopnje SVR po podskupinah bolnikov: študija C211 T12(b.i.d.
English: Pregnancy precautions for men and women
Slovenian: Kontracepcija pri moških in ženskah
English: Tell your doctor if you have heart failure, irregular heartbeat, slow heart rate, an abnormality shown in your heart tracing (ECG) called 'long QT syndrome', or a family history of a heart condition called 'congenital QT syndrome'.
Slovenian: Povejte svojemu zdravniku, če imate srčno popuščanje, nereden srčni utrip, počasen srčni utrip, motnjo, ki se kaže na elektrokardiogramu (EKG) in se imenuje “sindrom dolgega intervala QT” ali imate v družini srčno bolezen, imenovano “kongenitalni sindrom QT”.
English: The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Slovenian: Smer puščice (↑ = povečanje, ↓ = zmanjšanje, ↔ = ni spremembe) za vsak farmakokinetični parameter temelji na 90% intervalu zaupanja za razmerje geometrične sredine, ki je v okviru razpona 80-125% (↔), ali pod (↓) oziroma nad (↑) njim.
English: Table 2: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Slovenian: Preglednica 2: INTERAKCIJE IN PRIPOROČILA ZA ODMERJANJE Z DRUGIMI ZDRAVILI Zdravila po terapevtskih področjih
English: In two double-blind, randomised, placebo- and active-controlled studies conducted to evaluate the effect on the QT interval, telaprevir monotherapy at a dose of 750 mg every 8 hours was not associated with a clinically relevant effect on QTcF interval.
Slovenian: V dveh dvojno slepih, randomiziranih in s placebom ter aktivno učinkovino nadzorovanih študijah, ki sta bili opravljeni za ovrednotenje vpliva zdravila na interval QT, monoterapija s telaprevirjem v odmerku 750 mg na vsakih 8 ur ni bila povezana s klinično pomembnimi učinki na interval QTcF.
English: Hormonal contraceptives may be continued but may not be reliable during INCIVO dosing and for up to two months following cessation of INCIVO (see section 4.5).
Slovenian: Med jemanjem zdravila INCIVO se uporaba hormonskih kontraceptivov lahko nadaljuje, vendar le-ti morda ne bodo zanesljivi še do dva meseca po ukinitvi zdravila INCIVO (glejte poglavje 4.5).
English: Medicinal products
Slovenian: Zdravila
English: The Marketing Authorisation Holder shall agree to the format and content of the healthcare professional educational pack with the National Competent Authority prior to launch in the Member State.
Slovenian: Imetnik dovoljenja za promet z zdravilom se bo za obliko in vsebino izobraževalnih gradiv za zdravstvene delavce pred dajanjem zdravila na trg dogovoril s pristojnim nacionalnim organom države
English: All telaprevir-resistant variants studied remained fully sensitive to interferon-alfa, ribavirin, and representative HCV nucleoside and non-nucleoside polymerase inhibitors in the replicon system.
Slovenian: Vse preučevane variante, ki so bile rezistentne za telaprevir, so ostale popolnoma občutljive za interferon-alfa, ribavirin in reprezentativne nukleozidne in nenukleozidne zaviralce polimeraze HCV v sistemu replikonov.
English: The most marked effects are expected on oral, nasal and buccal/sublingual fentanyl formulations.
Slovenian: Najbolj izražene učinke pričakujemo pri peroralnih intranazalnih in bukalnih/sublingvalnih oblikah fentanila.
English: (7.0-8.9 g/dl or any decrease ≥ 4.5 g/dl)
Slovenian: (70-89 g/l ali kakršnokoli zmanjšanje ≥ 45 g/l)
English: Unless your doctor tells you to stop, continue taking INCIVO in order to ensure that your medicine continues to work against the virus.
Slovenian: Če vam zdravnik ne naroči, da prenehajte jemati zdravilo INCIVO, morate nadaljevati z njegovim jemanjem, saj s tem zagotovite, da še naprej deluje proti virusom.
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take INCIVO.
Slovenian: Zdravnik bo lahko tudi ocenil jetrno bolezen, preden se bo odločil, ali smete jemati zdravilo INCIVO.
English: Patients experiencing mild to moderate rash should be monitored for signs of progression; however, progression was infrequent (less than 10%).
Slovenian: Bolnike z blagim do zmernim izpuščajem je treba spremljati glede morebitnih znakov napredovanja izpuščaja, čeprav se je to dogajalo le redko (v manj kot 10% primerov).
English: • Pictures of rash according to different grades
Slovenian: • slike izpuščajev različnih stopenj
English: Population pharmacokinetic analysis of INCIVO in HCV-infected subjects indicated that the exposure to telaprevir was similar in Blacks/African-Americans and Caucasians.
Slovenian: Analiza populacijske farmakokinetike zdravila INCIVO pri preiskovancih, okuženih s HCV, je pokazala podobno izpostavljenost telaprevirju pri črncih/afroameričanih in belcih.
English: For additional information, see sections 4.5 and 4.6.
Slovenian: Za dodatne podatke glejte poglavji 4.5 in 4.6.
English: T12/PR All Patients N=540
Slovenian: T12/PR Vsi bolniki N = 540
English: When administered to lactating rats, levels of telaprevir and its major metabolite were higher in milk compared to those observed in plasma.
Slovenian: Pri podganah v fazi laktacije so bile koncentracije telaprevirja in njegovega glavnega presnovka v mleku višje od koncentracij v plazmi.
English: In vitro studies demonstrated that telaprevir is not an inhibitor of UGT1A9 or UGT2B7.
Slovenian: In vitro študije so pokazale, da telaprevir ni zaviralec encimov UGT1A9 in UGT2B7.
English: SVR rates for patient subgroups: Study 108
Slovenian: Preglednica 8: stopnje SVR za podskupine bolnikov: študija 108 Podskupina
English: Such patients should be closely monitored, including ECG assessments.
Slovenian: Te bolnike je treba skrbno spremljati, vključno s snemanjem EKG.
English: Telaprevir has not been tested for its carcinogenic potential.
Slovenian: Kancerogenosti telaprevirja niso testirali.
English: After oral administration, the typical apparent volume of distribution (Vd) was estimated to be 252 l, with an inter-individual variability of 72.2%.
Slovenian: Po peroralni uporabi je znašal njegov ocenjeni značilni navidezni porazdelitveni volumen (Vd) 252 l, variabilnost med posamezniki pa je bila 72,2%.
English: No studies on the effects of INCIVO on the ability to drive and use machines have been performed.
Slovenian: Študij učinkov zdravila INCIVO na sposobnost vožnje in upravljanja s stroji niso izvedli.
English: Dose reduction for parenterally administered midazolam should be considered, especially if more than a single dose of midazolam is administered.
Slovenian: Po potrebi zmanjšajte odmerek parenteralno danega midazolama, še posebej, če ste bolniku predpisali več kot en odmerek midazolama.
English: The pharmacokinetics of telaprevir were assessed after administration of a single dose of 750 mg to HCV-negative subjects with severe renal impairment (CrCl < 30 ml/min).
Slovenian: Farmakokinetiko telaprevirja so ocenili po zaužitju enkratnega 750 mg odmerka pri za HCV negativnih preiskovancih s hudo ledvično okvaro (CrCl < 30 ml/min).
English: During this time, female patients of childbearing potential should use two effective non-hormonal methods of contraception.
Slovenian: V tem času morajo ženske v rodni dobi uporabljati dve učinkoviti ne-hormonski kontracepcijski metodi.
English: Female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during INCIVO treatment and afterwards as recommended in the Summary of Product Characteristics for ribavirin, and as described below.
Slovenian: Bolnice v rodni dobi in njihovi partnerji pa tudi moški bolniki in njihove partnerke morajo med zdravljenjem z zdravilom INCIVO, po zaključku pa skladno z navodili v Povzetku glavnih značilnosti zdravila ribavirin in kot je opisano v nadaljevanju, uporabljati 2 učinkoviti kontracepcijski metodi.
English: - Heart problems
Slovenian: - Srčne bolezni
English: Co-administration of fluticasone or budesonide and telaprevir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
Slovenian: Sočasna uporaba flutikazona ali budezonida s telaprevirjem torej ni priporočljiva, razen če njegova morebitna korist za bolnika odtehta tveganja za sistemske neželene učinke kortikosteroidov.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin, therefore, extreme care must be taken to avoid pregnancy in female patients and
Slovenian: Pri vseh živalskih vrstah, ki so bile izpostavljene ribavirinu, so dokazali pomembne teratogene in/ali embriocidne učinke, zato je potrebno izredno skrbno preprečevati nosečnost pri bolnicah in tudi pri
English: INCIVO contains a substance called telaprevir and belongs to a group of medicines called ‘NS3-4A protease inhibitors'.
Slovenian: Zdravilo INCIVO vsebuje snov telaprevir in sodi v skupino zdravil, ki jih imenujemo ‘zaviralci NS3-4A proteaze'.
English: Telaprevir is partly metabolised in the liver by CYP3A and is a P-glycoprotein (P-gp) substrate.
Slovenian: Telaprevir se delno presnavlja v jetrih z izoencimom CYP3A in je substrat P-glikoproteina (P-gp).
English: INCIVO has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo INCIVO nima vpliva ali ima le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: In both rats and dogs, AST/ALT elevations were observed in most studies, of which the increase in ALT in rats was not normalised after recovery.
Slovenian: Pri podganah in pri psih so v večini študij opazili povečanje koncentracij AST/ALT, pri čemer se koncentracije ALT pri podganah po odtegnitvi zdravila niso normalizirale.
English: Since it is highly unlikely that patients with inadequate viral responses will achieve a sustained virologic response (SVR), it is recommended that patients with HCV RNA > 1,000 IU/ml at week 4 or week 12 discontinue therapy (refer to table 1).
Slovenian: Ker je zelo malo verjetno, da bodo bolniki z nezadostnim virološkim odzivom dosegli trajni virološki odziv (SVR - sustained virologic response), je priporočljivo, da bolnikom, ki imajo v 4. ali 12. tednu koncentracije HCV RNK > 1.000 i.e./ml, zdravljenje ukinete (glejte preglednico 1).
English: • Incidence of rash and severe cutaneous reactions
Slovenian: • pojavnost izpuščaja in hudih kožnih reakcij
English: The European Medicines Agency has deferred the obligation to submit the results of studies with INCIVO in one or more subsets of the paediatric population in chronic hepatitis C (see section 4.2 for
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom INCIVO za eno ali več podskupin pediatrične populacije s kronično okužbo z virusom hepatitisa C. Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
English: (≥ 4.91 mmol/l ≥ 191 mg/dl)
Slovenian: (≥ 4,91 mmol/l ≥ 1.910 mg/l)
English: Concomitant administration of INCIVO and quetiapine is contraindicated as it may increase quetiapine-related toxicity.
Slovenian: Sočasna uporaba zdravila INCIVO in kvetiapina je kontraindicirana, ker lahko poveča s kvetiapinom povezano toksičnost.
English: rifampicin to treat some infections like tuberculosis (antimycobacterial)
Slovenian: rifampicin za zdravljenje nekaterih okužb, kot je tuberkuloza (zdravila proti mikobakterijam)
English: Peginterferon alfa may be continued unless interruption is medically indicated.
Slovenian: Zdravljenje s peginterferonom alfa se lahko nadaljuje, če prekinitev ni indicirana.
English: ® HCV test (version 2.0), for use with the High Pure System.
Slovenian: ® TaqMan HCV (različica 2.0) za uporabo s sistemom High Pure System, ki ima spodnjo mejo kvantifikacije
English: Clonal sequencing analysis of a subset of patients who had wild-type HCV by population sequencing (n=20), comparing the frequency of resistant variants before the start of telaprevir treatment and at follow-up, showed that the HCV variant population in all patients had returned to pre-treatment levels.
Slovenian: Analiza klonskega sekvencioniranja v podskupini bolnikov, ki so imeli divji tip HCV, s pomočjo populacijskega sekvencioniranja (n = 20) za primerjavo pogostnosti rezistentnih variant pred začetkom zdravljenja s telaprevirjem in pri spremljanju bolnikov, je pokazala, da se je populacija variant HCV pri vseh bolnikih povrnila na vrednosti pred zdravljenjem.
English: astemizole, terfenadine to treat allergy symptoms (antihistamines)
Slovenian: astemizol, terfenadin za zdravljenje simptomov alergije (antihistaminiki)
English: Some patients may require higher doses of tacrolimus or cyclosporine A than at the initiation of treatment.
Slovenian: Nekateri bolniki bodo lahko potrebovali večje odmerke takrolimusa ali ciklosporina A, kot pred zdravljenjem z zdravilom INCIVO.
English: All patients N = 74 % (n/N)
Slovenian: Vsi bolniki N = 74 % (n/N)
English: On-treatment virologic failure during telaprevir treatment was predominantly associated with higher-level resistant variants, and relapse was predominantly associated with lower-level resistant variants or wild-type virus.
Slovenian: Opaženi primeri virološke neuspešnosti med zdravljenjem s telaprevirjem so bili povezani predvsem z višjimi rezistentnimi variantami, ponovitev bolezni pa je bila povezana predvsem z nižjimi rezistentnimi variantami ali z divjim tipom virusa.
English: INCIVO may affect other medicines or other medicines may affect INCIVO.
Slovenian: Zdravilo INCIVO lahko vpliva na delovanje drugih zdravil in druga zdravila lahko vplivajo na delovanje zdravila INCIVO.
English: Sequence analyses of the telaprevir-resistant variants identified substitutions at 4 positions in the NS3-4A protease region, consistent with the mechanism of action for telaprevir (V36A/M, T54A/S, R155K/T, and A156S/T/V).
Slovenian: Sekvencijske analize za telaprevir rezistentnih variant so pokazale substitucije na 4 položajih v regiji NS3-4A proteaze, kar je v skladu z mehanizmom delovanja telaprevirja (V36A/M, T54A/S, R155K/T in A156S/T/V).
English: A dose adjustment of metformin may be necessary.
Slovenian: Morda bo potrebno prilagoditi odmerek metformina.
English: The safety and efficacy have not been established in patients with moderate or severe renal impairment (CrCl < 50 ml/min) or in patients on haemodialysis.
Slovenian: Varnost in učinkovitost pri bolnikih z zmerno ali hudo ledvično okvaro (CrCl < 50 ml/min) in pri bolnikih, ki se zdravijo s hemodializo, ni bila dokazana.
English: In vitro studies performed with human Caco-2 cells indicated that telaprevir is a substrate of P-glycoprotein (P-gp).
Slovenian: Študije in vitro, ki so bile opravljene s človeškimi celicami Caco-2, pa so tudi pokazale, da je telaprevir substrat P-glikoproteina (P-gp).
English: INCIVO is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila INCIVO ne smete uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: )/PR over T12(q8h)/PR.
Slovenian: )/PR in T12(q8h)/PR.
English: The in vitro replication capacity of telaprevir-resistant variants was lower than that of wild-type virus.
Slovenian: Replikacijska kapaciteta za telaprevir odpornih variant in vitro je bila manjša od replikacijske kapacitete virusa divjega tipa.
English: If you belong to this age group, please discuss the use of INCIVO with your doctor.
Slovenian: Če sodite v to starostno skupino, se o uporabi zdravila INCIVO pogovorite s svojim zdravnikom.
English: Contact your doctor immediately also if you develop any of the following symptoms: - tiredness, weakness, shortness of breath, light-headedness, and/or feeling of heart racing.
Slovenian: Takoj se obrnite na svojega zdravnika tudi če se pojavi kateri izmed simptomov: - utrujenost, šibkost, zadihanost, vrtoglavica, in/ali občutek razbijanja srca.
English: Mechanism of action Telaprevir is an inhibitor of the HCV NS3•4A serine protease, which is essential for viral replication.
Slovenian: Telaprevir je zaviralec serinske proteaze HCV NS3•4A, ki je nujna za replikacijo virusov.
English: Tadalafil for treatment of erectile dysfunction can be used with caution at a single dose not exceeding 10 mg dose in 72 hours and with increased monitoring for tadalafil associated adverse events.
Slovenian: Tadalafil (za zdravljenje motenj erekcije) se lahko uporablja v enkratnem odmerku do 10 mg na 72 ur in ob natančnejšem spremljanju pojava s tadalafilom povezanih neželenih učinkov.
English: (> 7.77 mmol/l > 300 mg/dl)
Slovenian: (> 7,77 mmol/l > 3.000 mg/l)
English: The SVR rate for the T8/PR group was 72% (261/364) (P < 0.0001 compared to Pbo/PR48 group).
Slovenian: Stopnja trajnega virološkega odziva za skupino T8/PR je znašala 72% (261/364) (P < 0,0001 za primerjavo s skupino Pbo/PR48).
English: HCV variants associated with on-treatment virologic failure or relapse were evaluated by site-directed mutagenesis in the replicon assay.
Slovenian: Variante virusa HCV, povezane z virološko neuspešnostjo zdravljenja ali s ponovitvami bolezni, so ovrednotili s tarčno usmerjeno mutagenezo v testu replikonov.
English: The exposure to telaprevir was increased by 20% when taken following a high-fat caloric meal (56 g fat, 928 kcal) compared to an intake following a standard normal caloric meal (21 g fat, 533 kcal).
Slovenian: Izpostavljenost telaprevirju se je povečala za 20%, ko so ga bolniki zaužili po mastnem in kaloričnem obroku (56 g maščob, 928 kcal) v primerjavi z zaužitjem zdravila po običajnem obroku z normalnim številom kalorij (21 g maščob, 533 kcal).
English: - Anaemia (decrease in your red blood cells) Tell your doctor if you experience tiredness, weakness, shortness of breath, light-headedness, and/or the feeling of the heart racing.
Slovenian: - Anemija (zmanjšanje števila rdečih krvničk) Povejte svojemu zdravniku, če občutite utrujenost, šibkost, zasoplost, vrtoglavico in/ali občutek razbijanja srca.
English: Telaprevir readily crosses the placenta in both rat and mouse giving a foetal: maternal exposure of 19 - 50%.
Slovenian: Telaprevir pri podganah in pri miših prehaja skozi placento, pri čemer je razmerje izpostavljenosti plod: mati 19-50%.
English: Of the 393 resistant variants detected in the 255 patients, 68% of NS3-36, 84% of NS3-54, 59% of NS3-155, 86% of NS3-156, and 52% of NS3-36M+NS3-155K variants were no longer detected.
Slovenian: Od 393 rezistentnih variant, ugotovljenih pri 255 bolnikih, pa le-teh več niso ugotovili pri 68% NS3-36, 84% NS3-54, 59% NS3-155, 86% NS3-156 in 52% NS3-36M+NS3-155K.
English: Efavirenz: with this combination the telaprevir dose must be increased to 1,125 mg three times per day (q8h).
Slovenian: Efavirenz: v tej kombinaciji je treba odmerek telaprevirja zvečati na 1.125 mg trikrat na dan (na 8 ur).
English: Patients with renal or hepatic impairment should not be given colchicine with INCIVO, due to the risk of colchicine toxicity.
Slovenian: Bolniki z ledvično ali jetrno okvaro ne smejo prejemati kolhicina skupaj z zdravilom INCIVO zaradi tveganja za toksičnost kolhicina.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji
English: Telaprevir is orally available, most likely absorbed in the small intestine, with no evidence for absorption in the colon.
Slovenian: Telaprevir je peroralno uporaben in se najverjetneje absorbira v tankem črevesu, saj ni nobenih znakov njegove absorpcije v debelem črevesu.
English: Potent CYP3A inducers, such as carbamazepine, phenytoin and phenobarbital, are contraindicated
Slovenian: Močni CYP3A induktorji, kot so karbamazepin, fenitoin in fenobarbital so
English: Patients with HCV genotype 1a predominately had V36M and R155K single and combination variants, while patients with HCV genotype 1b predominately had V36A, T54A/S, and A156S/T/V variants.
Slovenian: Bolniki s HCV genotipa 1a so imeli pretežno enojne in kombinirane variante V36M in R155K, medtem ko so imeli bolniki s HCV genotipa 1b pretežno variante V36A, T54A/S in A156S/T/V.
English: See also section 4.3 for medicinal products which are contraindicated with INCIVO.
Slovenian: Glejte tudi poglavje 4.3, kjer so navedena zdravila, katerih jemanje skupaj z zdravilom INCIVO je kontraindicirano.
English: to treat a heart and lung disorder called pulmonary arterial hypertension (endothelin receptor antagonist)
Slovenian: za zdravljenje srčne in pljučne bolezni, imenovane pljučna arterijska hipertenzija (antagonist endotelinskih receptorjev)
English: Any birth control method can fail, and, therefore, you and your partner must use at least two effective birth control methods during INCIVO therapy and afterwards.
Slovenian: Vsaka kontracepcijska metoda lahko odpove in zato morata tako vi, kot tudi vaš partner/partnerica med in po zdravljenju z zdravilom INCIVO uporabljati vsaj dve učinkoviti kontracepcijski metodi.