natgillin/translations-raw huggingface dataset:
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 
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.
(≥ 4.91 mmol/l ≥ 191 mg/dl) 
(≥ 4,91 mmol/l ≥ 1.910 mg/l)
Concomitant administration of INCIVO and quetiapine is contraindicated as it may increase quetiapine-related toxicity. 
Sočasna uporaba zdravila INCIVO in kvetiapina je kontraindicirana, ker lahko poveča s kvetiapinom povezano toksičnost.
rifampicin to treat some infections like tuberculosis (antimycobacterial) 
rifampicin za zdravljenje nekaterih okužb, kot je tuberkuloza (zdravila proti mikobakterijam)
Peginterferon alfa may be continued unless interruption is medically indicated. 
Zdravljenje s peginterferonom alfa se lahko nadaljuje, če prekinitev ni indicirana.
® HCV test (version 2.0), for use with the High Pure System. 
® TaqMan HCV (različica 2.0) za uporabo s sistemom High Pure System, ki ima spodnjo mejo kvantifikacije
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. 
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.
astemizole, terfenadine to treat allergy symptoms (antihistamines) 
astemizol, terfenadin za zdravljenje simptomov alergije (antihistaminiki)
Some patients may require higher doses of tacrolimus or cyclosporine A than at the initiation of treatment. 
Nekateri bolniki bodo lahko potrebovali večje odmerke takrolimusa ali ciklosporina A, kot pred zdravljenjem z zdravilom INCIVO.
All patients N = 74 % (n/N) 
Vsi bolniki N = 74 % (n/N)
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. 
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.
INCIVO may affect other medicines or other medicines may affect INCIVO. 
Zdravilo INCIVO lahko vpliva na delovanje drugih zdravil in druga zdravila lahko vplivajo na delovanje zdravila INCIVO.
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). 
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).
A dose adjustment of metformin may be necessary. 
Morda bo potrebno prilagoditi odmerek metformina.
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. 
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.
In vitro studies performed with human Caco-2 cells indicated that telaprevir is a substrate of P-glycoprotein (P-gp). 
Študije in vitro, ki so bile opravljene s človeškimi celicami Caco-2, pa so tudi pokazale, da je telaprevir substrat P-glikoproteina (P-gp).
INCIVO is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Zdravila INCIVO ne smete uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
)/PR over T12(q8h)/PR. 
)/PR in T12(q8h)/PR.
The in vitro replication capacity of telaprevir-resistant variants was lower than that of wild-type virus. 
Replikacijska kapaciteta za telaprevir odpornih variant in vitro je bila manjša od replikacijske kapacitete virusa divjega tipa.
If you belong to this age group, please discuss the use of INCIVO with your doctor. 
Če sodite v to starostno skupino, se o uporabi zdravila INCIVO pogovorite s svojim zdravnikom.
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. 
Takoj se obrnite na svojega zdravnika tudi če se pojavi kateri izmed simptomov: - utrujenost, šibkost, zadihanost, vrtoglavica, in/ali občutek razbijanja srca.
Mechanism of action Telaprevir is an inhibitor of the HCV NS3•4A serine protease, which is essential for viral replication. 
Telaprevir je zaviralec serinske proteaze HCV NS3•4A, ki je nujna za replikacijo virusov.
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. 
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.
(> 7.77 mmol/l > 300 mg/dl) 
(> 7,77 mmol/l > 3.000 mg/l)
The SVR rate for the T8/PR group was 72% (261/364) (P < 0.0001 compared to Pbo/PR48 group). 
Stopnja trajnega virološkega odziva za skupino T8/PR je znašala 72% (261/364) (P < 0,0001 za primerjavo s skupino Pbo/PR48).
HCV variants associated with on-treatment virologic failure or relapse were evaluated by site-directed mutagenesis in the replicon assay. 
Variante virusa HCV, povezane z virološko neuspešnostjo zdravljenja ali s ponovitvami bolezni, so ovrednotili s tarčno usmerjeno mutagenezo v testu replikonov.
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). 
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).
- 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. 
- Anemija (zmanjšanje števila rdečih krvničk) Povejte svojemu zdravniku, če občutite utrujenost, šibkost, zasoplost, vrtoglavico in/ali občutek razbijanja srca.
Telaprevir readily crosses the placenta in both rat and mouse giving a foetal: maternal exposure of 19 - 50%. 
Telaprevir pri podganah in pri miših prehaja skozi placento, pri čemer je razmerje izpostavljenosti plod: mati 19-50%.
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. 
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.
Efavirenz: with this combination the telaprevir dose must be increased to 1,125 mg three times per day (q8h). 
Efavirenz: v tej kombinaciji je treba odmerek telaprevirja zvečati na 1.125 mg trikrat na dan (na 8 ur).
Patients with renal or hepatic impairment should not be given colchicine with INCIVO, due to the risk of colchicine toxicity. 
Bolniki z ledvično ali jetrno okvaro ne smejo prejemati kolhicina skupaj z zdravilom INCIVO zaradi tveganja za toksičnost kolhicina.
Do not take a double dose to make up for a forgotten dose. 
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji
Telaprevir is orally available, most likely absorbed in the small intestine, with no evidence for absorption in the colon. 
Telaprevir je peroralno uporaben in se najverjetneje absorbira v tankem črevesu, saj ni nobenih znakov njegove absorpcije v debelem črevesu.
Potent CYP3A inducers, such as carbamazepine, phenytoin and phenobarbital, are contraindicated 
Močni CYP3A induktorji, kot so karbamazepin, fenitoin in fenobarbital so
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. 
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.
See also section 4.3 for medicinal products which are contraindicated with INCIVO. 
Glejte tudi poglavje 4.3, kjer so navedena zdravila, katerih jemanje skupaj z zdravilom INCIVO je kontraindicirano.
to treat a heart and lung disorder called pulmonary arterial hypertension (endothelin receptor antagonist) 
za zdravljenje srčne in pljučne bolezni, imenovane pljučna arterijska hipertenzija (antagonist endotelinskih receptorjev)
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. 
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.
Proton pump inhibitors can be used without dose modification. 
Zaviralci protonske črpalke se lahko uporabljajo sočasno brez prilagoditve odmerka.
In HCV-negative patients with severe renal impairment, no clinically relevant change in telaprevir exposure was observed (see section 5.2). 
Pri bolnikih s hudo okvaro ledvic, ki niso bili okuženi s HCV, niso opazili klinično pomembnih sprememb v izpostavljenosti telaprevirju (glejte poglavje 5.2).
If you are breast-feeding, you must stop breast-feeding before starting to take INCIVO. 
Če dojite, morate prenehati z dojenjem, preden začnete jemati zdravilo INCIVO.
High density polyethylene (HDPE) bottle containing 42 film-coated tablets and fitted with polypropylene (PP) child resistant closure and induction seal liner. 
Plastenka iz polietilena velike gostote (HDPE), z 42 filmsko obloženimi tabletami in z za otroke varno polipropilensko (PP) zaporko z indukcijsko tesnilno folijo.
Increase in thyroid stimulating hormone (TSH) may occur during INCIVO combination treatment, which may indicate worsening or recurrence of pre-existing or previous hypothyroidism, or new-onset hypothyroidism (see section 4.8). 
Med kombiniranim zdravljenjem z zdravilom INCIVO lahko pride do zvišanja koncentracije tirotropina (TSH), kar lahko kaže na poslabšanje ali ponovitev obstoječega ali predhodnega hipotiroidizma ali pojav hipotiroidizma (glejte poglavje 4.8).
Administration of INCIVO may increase systemic exposure to medicinal products that are substrates of CYP3A or P-gp, which could increase or prolong their therapeutic effect and adverse reactions. 
Uporaba zdravila INCIVO lahko zveča sistemsko izpostavljenost učinkovinam, ki se presnavljajo s CYP3A ali P-gp, kar lahko zveča ali podaljša njihov terapevtski učinek in neželene učinke.
In general, exposure levels in relation to human values were low in animal pharmacology and toxicology studies. 
Na splošno so bile izpostavljenosti v farmakoloških in toksikoloških študijah na živalih majhne glede na izpostavljenosti pri ljudeh.
Concomitant administration with Class Ia or III antiarrhythmics, except for intravenous lidocaine (see section 4.5). 
Sočasna uporaba s katerimkoli antiaritmikom Ia ali III, razen intravensko danega lidokaina (glejte poglavje 4.5).
The median time for telaprevir-resistant variants to become undetectable by population sequencing was longer for variants NS3-36 (6 months), NS3-155 (9 months) and NS3-36M+NS3-155K (12 months) predominantly observed in patients with genotype 1a than for variants NS3-54 (2 months) and NS3-156 (3 months) predominantly observed in patients with genotype 1b. 
Mediani čas, da za telaprevir odporne variante niso bile več zaznavne s populacijskim sekvenciranjem je bil daljši za variante NS3-36 (6 mesecev), NS3-155 (9 mesecev) in NS3-36M+NS3-155K (12 mesecev), ki so jih predvsem opazili pri bolnikih z genotipom 1a, kot za variante NS3-54 (2 meseca) in NS3-156 (3 mesece), ki so jih predvsem opazili pri bolnikih z
In the analysis of an additional study, Study C211, the safety profile of combination therapy with INCIVO 1,125 mg twice daily was similar to the safety profile for patients receiving combination therapy with INCIVO 750 mg every 8 hours. 
Pri analizi dodatne študije (študija C211) je bil varnostni profil kombiniranega zdravljenja z zdravilom INCIVO v odmerku 1.125 mg dvakrat na dan podoben varnostnemu profilu pri bolnikih, ki so prejemali kombinirano zdravljenje z zdravilom INCIVO v odmerku 750 mg na 8 ur.
Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia. 
Zmanjšanje odmerka ribavirina je najprimernejši način obvladovanja med zdravljenjem nastale anemije.
Telaprevir inhibits organic anion transporter polypeptides (OATPs) OATP1B1 and OATP2B1. 
Telaprevir zavira organska anionska polipeptidna prenašalca (OATP- organic anion transporter polypeptides) OATP1B1 in OATP2B1.
Detectable HCV RNA below the lower limit of assay quantification should not be used as a substitute for “undetectable” (target not detected), for making decisions on treatment duration, as this may lead to an insufficient duration of therapy and higher relapse rates. 
Zaznavnih koncentracij HCV RNK, nižjih od spodnje meje kvantifikacije, se, pri odločanju o trajanju zdravljenja ne sme zamenjevati z nezaznavnimi koncentracijami (nezaznaven analit), ker to lahko vodi v prekratek čas zdravljenja in večje stopnje relapsa.
Consult with a specialist in dermatology. 
Posvetujte se z dermatologom.
Table 10: SVR rates by extent of liver fibrosis at baseline: Study 111 
Preglednica 10: stopnje SVR po obsegu jetrne fibroze na začetku študije: študija 111
Patients received INCIVO at a dosage of 750 mg every 8 hours. 
Bolniki so prejemali zdravilo INCIVO v odmerku 750 mg vsakih 8 ur.
Use of INCIVO should be avoided in patients with congenital QT prolongation, or a family history of congenital QT prolongation or sudden death. 
Uporabi zdravila INCIVO pri bolnikih s kongenitalnim podaljšanjem intervala QT oziroma s kongenitalnim podaljšanjem intervala QT ali primeri nenadne smrti v družinski anamnezi se je treba izogibati.
In the case of missing data within the week 72 window, the last HCV RNA data point from week 12 of follow-up onwards was used. 
Če v 72. tednu ni bilo podatkov, je bil uporabljen zadnji podatek o koncentraciji HCV RNK po 12. tednu.
Your doctor will measure blood levels of your virus at weeks 4 and 12 to determine your treatment duration. 
V 4. in 12. tednu bo zdravnik preveril koncentracijo virusa v krvi, da bo lahko določil čas trajanja vašega zdravljenja.
Chemistry evaluations (electrolytes, serum creatinine, uric acid, hepatic enzymes, bilirubin, TSH) are recommended as frequently as the haematology evaluations or as clinically indicated (see section 4.8). 
Tudi biokemične preiskave (elektroliti, določanje kreatinina v serumu, sečna kislina, jetrni encimi, bilirubin in TSH) je priporočeno opravljati tako pogosto kot hematološke preiskave ali pa glede na bolnikovo klinično stanje (glejte poglavje 4.8).
If trazodone is used with telaprevir, the combination should be used with caution and a lower dose of trazodone should be considered. 
Če torej uporabljate trazodon skupaj s telaprevirjem, je treba to kombinacijo uporabljati previdno in po potrebi bolniku predpisati manjši odmerek trazodona.
Clinical drug-drug interaction studies with substrates of CYP2B6, CYP2C8, CYP2D6, CYP2C19 and UGT1A1, UGT2B7 and UGT1A3 indicate no clinically relevant impact of the suppression observed in vitro. 
Klinične študije medsebojnih delovanj s substrati CYP2B6, CYP2C8, CYP2D6, CYP2C19 ter UGT1A1, UGT2B7 in UGT1A3 pa niso pokazale klinično pomembnega učinka in vitro opažene supresije.
Variants V36A/M, T54A/S, R155K/T, and A156S conferred lower levels of in vitro resistance to telaprevir (3- to 25-fold increase in telaprevir IC50), and the A156V/T and V36M+R155K variants conferred higher levels of in vitro resistance to telaprevir (> 25-fold increase in telaprevir IC50). 
Variante V36A/M, T54A/S, R155K/T in A156S so pokazale nižje stopnje rezistence na telaprevir in vitro (3-kratno do 25-kratno zvečanje IC50 za telaprevir), varianti A156V/T in V36M+R155K sta imeli višjo stopnjo rezistence in vitro za telaprevir (> 25-kratno zvečanje IC50 za telaprevir).
warfarin, dabigatran to prevent blood clots (anticoagulants) 
varfarin, dabigatran za preprečevanje nastanka krvnih strdkov (antikoagulanti)
Therefore, you and your partner must use two other birth control methods during the time you are taking INCIVO and for 2 months after stopping this medicine. 
Zato morate vi in vaš partner med in še dva meseca po koncu zdravljenja z zdravilom INCIVO uporabljati dve drugi kontracepcijski metodi.
To manage anaemia, at initiation of INCIVO treatment a lower starting dose of ribavirin (600 mg/day) was used; during the overall treatment phase the ribavirin dose was further reduced in 36.5% of patients, 41.9% received ESAs and 21.6% received blood transfusions (see sections 4.4 and 4.5, Immunosuppressants). 
Za nadzorovanje anemije so ob uvedbi zdravila INCIVO uporabljali manjši odmerek ribavirina (600 mg/dan); med celotnim zdravljenjem so pri 36,5% bolnikov odmerek ribavirina še dodatno zmanjšali; 41,9% bolnikov je prejelo ESA; 21,6% bolnikov je prejelo transfuzijo krvi (glejte poglavji 4.4 in 4.5 Imunosupresivi).
Taking INCIVO without food or without regard to the dosing interval may result in decreased plasma concentrations of telaprevir which could reduce the 
Jemanje zdravila INCIVO brez hrane ali neupoštevanje intervala odmerjanja lahko povzroči znižanje plazemskih koncentracij telaprevirja in zmanjšanje terapevtskega učinka zdravila INCIVO.
Based on in vitro studies, telaprevir may potentially increase plasma concentrations of medicinal products in which excretion is dependent upon multidrug and toxin extrusion (MATE)-1 and MATE2-K (see table 2). 
In vitro študije kažejo, da telaprevir lahko zveča plazemske koncentracije učinkovin, katerih izločanje je odvisno od prenašalcev za ekstruzijo več učinkovin in toksinov MATE-1 (MATE - multidrug and toxin extrusion protein) in MATE2-K (glejte preglednico 2).
A total of 215 of 1,169 patients treated with a T12/PR regimen in a Phase 3 clinical trial had on-treatment virologic failure (n = 125) or relapse (n = 90). 
Pri skupaj 215 od 1.169 bolnikov, zdravljenih s shemo T12/PR v kliničnem preskušanju faze III, so med zdravljenjem ugotovili virološki neuspeh (n = 125) ali ponovitev bolezni (n = 90).
Rare side effects (affects less than 1 in 1,000 people): - a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome). 
Redki neželeni učinki (pojavijo se pri manj kot 1 od 1.000 bolnikov) - razširjen hud izpuščaj z luščenjem kože, ki ga lahko spremljajo zvišana telesna temperatura, gripi podobni simptomi ter pojav mehurjev v ustih, na očeh in/ali na genitalijah (Stevens-Johnsonov sindrom).
Other enzymes are also involved in the metabolism (see section 5.2). 
Pri presnovi sodelujejo tudi drugi encimi (glejte poglavje 5.2).
For moderate rash that progresses to severe (≥ 50% body surface area), permanently discontinue INCIVO (see below). 
Če zmerni izpuščaj napreduje v hudega (≥ 50% telesne površine), je treba ukiniti zdravilo INCIVO (glejte spodaj).
The total duration of treatment of peginterferon alfa and ribavirin varies from 24 to 48 weeks depending on treatment response and whether you have been treated before. 
Celotno zdravljenje s peginterferonom alfa in ribavirinom traja od 24 do 48 tednov, kar je odvisno od odziva na zdravljenje in ali ste se že prej zdravili.
Table 5 shows the response rates for the T12(b.i.d. 
V preglednici 5 so prikazane stopnje odziva za skupini T12(b.i.d.
In a fertility and early embryonic development study in rats, an increase in non-viable conceptuses was observed. 
V študiji plodnosti in zgodnjega razvoja zarodka pri podganah so opazili povečano število mrtvih zarodkov.
Following completion of INCIVO therapy contraceptive recommendations should be followed as in the Summary of Product Characteristics for ribavirin, and as described below. 
Po zaključku zdravljenja z zdravilom INCIVO je treba upoštevati navodila v Povzetku glavnih značilnosti zdravila ribavirin in kot je opisano v nadaljevanju.
When INCIVO is used in patients with advanced liver disease very close monitoring and early management of adverse events is recommended. 
Kadar se zdravilo uporablja pri bolniku z napredovalo boleznijo jeter je priporočeno skrbno spremljanje in zgodnja obravnava neželenih učinkov.
Tablet film-coat polyvinyl alcohol macrogol talc titanium dioxide (E171) iron oxide yellow (E172) 
polivinilalkohol, makrogol, smukec, titanov dioksid (E171), rumeni železov oksid (E172)
After oral administration, the apparent total clearance (Cl/F) was estimated to be 32.4 l/h with an inter-individual variability of 27.2%. 
Po peroralni uporabi je bila ocenjena vrednost navideznega skupnega očistka (Cl/F) 32,4 l/h z 27,2% stopnjo variabilnosti med posamezniki.
OTHER CONDITIONS AND REQUIREMENTS OF THE 
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin, including pregnancy testing requirements (see section 4.6). 
Preberite tudi Povzetek glavnih značilnosti zdravil peginterferon alfa in ribavirin, vključno z zahtevami glede testiranja nosečnosti (glejte poglavje 4.6).
Concomitant use may lead to adverse events such as nausea, dizziness, hypotension and syncope. 
Sočasna uporaba lahko vodi do pojava neželenih učinkov, kot sonavzea, omotica, hipotenzija in sinkopa.
Study 111 was a Phase 3, randomised, open label study conducted in treatment-naïve patients. 
Študija 111 je bila randomizirana, odprta študija faze III, ki je bila opravljena pri še nezdravljenih bolnikih.
Fifty-five out of 60 patients received ribavirin at a fixed dose of 800 mg/day and the remaining 5 patients received a weight-based ribavirin dose. 
Izmed 60 bolnikov jih je 55 prejemalo fiksni odmerek 800 mg ribavirina/dan, 5 bolnikov pa je prejemalo odmerke ribavirina na osnovi telesne mase.
Rarely patients may have other symptoms with the rash that may be a sign of a severe skin reaction. 
Redko se skupaj z izpuščajem pojavijo tudi drugi simptomi, ki lahko kažejo na hudo kožno reakcijo.
Due to the combined treatment with peginterferon alfa and ribavirin, 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. 
Zaradi kombiniranega zdravljenja s peginterferonom alfa in ribavirinom, morajo bolnice v rodni dobi in njihovi partnerji ter bolniki in njihove partnerice med zdravljenjem z zdravilom INCIVO uporabljati 2 učinkoviti kontracepcijski metodi.
HIV-ANTIVIRAL AGENTS: HIV-PROTEASE INHIBITORS (PIs) atazanavir/ritonavir* 
ZDRAVILA PROTI OKUŽBI Z VIRUSOM HIV: ZAVIRALCI PROTEAZE HIV (PI) atazanavir/ritonavir*
Efficacy in adults with HCV/HIV-1 co-infection 
Učinkovitost pri odraslih bolnikih s sočasno okužbo s HCV/ HIV-1
Since INCIVO must be used in combination with ribavirin and ribavirin can be very damaging to an unborn baby, both female and male patients must take special precautions in order to prevent pregnancy. 
Zdravilo INCIVO je treba uporabljati v kombinaciji z ribavirinom in ribavirin lahko škoduje nerojenemu otroku, zato morajo bolnice in bolniki upoštevati posebne ukrepe za preprečevanje nosečnosti.