FrancophonIA/ELRC3.0 huggingface dataset:
English: Contents of the pack and other information What Exviera contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Exviera
English: Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection
Slovenian: Namen uporabe zdravila karbamazepin, fenitoin, fenobarbital pri epilepsiji efavirenz, etravirin, nevirapin pri okužbi z virusom HIV
English: c. Substitutions were observed in combination with other emergent substitutions at NS3 position R155 or D168.
Slovenian: c. Substitucije so opažali v kombinaciji z drugimi nastalimi substitucijami na mestih R155 in D168 NS3.
English: A side-by-side tabulation is provided to simplify presentation; direct comparisons should not be made across trials that differ in trial designs.
Slovenian: Za enostavnejšo predstavitev je tabeliranje vzporedno, vendar se ne sme neposredno primerjati preskušanj, ki so imela različne načrte.
English: For a general comment on treatment of HIV co-infected patients, including a discussion on different antiretroviral regimens that may be used, please see section 4.4 (Treatment of HIV co-infected patients) and the Summary of Product Characteristics of ombitasvir/ paritaprevir /ritonavir.
Slovenian: Za splošen komentar o zdravljenju bolnikov s sočasno okužbo z virusom HIV, vključno z diskusijo o različnih protivirusnih zdravljenjih, ki jih je možno uporabiti, glejte poglavje 4.4 (Zdravljenje bolnikov, sočasno okuženih s HIV) in povzetek glavnih značilnosti zdravila za ombitasvir/ paritaprevir /ritonavir.
English: Following a 400 mg 14C-dasabuvir dose in humans, unchanged dasabuvir was the major component (approximately 60%) of drug related radioactivity in plasma.
Slovenian: 14C-dasabuvirja pri človeku je bil nespremenjeni dasabuvir glavna sestavina (približno 60 %) z zdravilom povezane radioaktivnosti v plazmi.
English: Take one tablet in the evening.
Slovenian: Vzemite eno tableto zvečer.
English: Dasabuvir had no effects on embryo-foetal viability or on fertility in rodents and were not teratogenic in two species.
Slovenian: Dasabuvir pri glodalcih ni vplival na embrio-fetalno viabilnost ali na plodnost in pri dveh živalskih vrstah ni bil teratogen.
English: If an HIV protease inhibitor is added (atazanavir, darunavir), rilpivirine exposure may increase even further and is, therefore, not recommended.
Slovenian: Če je dodan zaviralec proteaze HIV (atazanavir, darunavir), se lahko izpostavljenost rilpivirinu še dodatno zveča, zato takšna uporaba ni priporočljiva.
English: The combination carries an increased risk for hyperbilirubinemia (including ocular icterus), in particular when ribavirin is part of the hepatitis C regimen.
Slovenian: Kombinacijo spremlja večje tveganje za hiperbilirubinemijo (vključno z očesnim ikterusom), še zlasti če je ribavirin vključen v shemo za hepatitis C.
English: Dasabuvir should be administered with food.
Slovenian: Dasabuvir je treba jemati s hrano.
English: Medicinal products transported by BCRP
Slovenian: Zdravila, ki se prenašajo z BCRP
English: If clinically indicated, higher doses of esomeprazole/lansopraz ole may be needed.
Slovenian: Če je klinično indicirano, bodo morda potrebni večji odmerki esomeprazola/lans oprazola.
English: TOTAL +Other types of pegIFN/RBV failure include less well documented non-response, relapse/breakthrough or other pegIFN failure.
Slovenian: +Druge vrste neuspehov s pegIFN/RBV vključuje slabše dokumentirane neodzive, recidive/preboje ali druge neuspehe s pegIFN.
English: The increase in exposure was similar regardless of meal type (e.g., high-fat versus moderate-fat) or calorie content (approximately 600 kcal versus approximately 1000 kcal).
Slovenian: Zvečanje izpostavljenosti je bilo podobno ne glede na vrsto obroka (npr. zelo masten obrok v primerjavi z zmerno mastnim) ali kalorično vrednost (približno 600 kcal v primerjavi s približno
English: Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation.
Slovenian: Bolnikom in skrbnikom je treba naročiti, naj obvestijo zdravnika o kakršnih koli spremembah v vedenju ali razpoloženju in o vseh samomorilnih mislih.
English: Dasabuvir was absorbed after oral administration with mean Tmax of approximately 4 to 5 hours.
Slovenian: Dasabuvir se je po peroralni uporabi absorbiral s povprečnim tmax približno 4 do 5 ur.
English: Some patients may also take an antiviral medicine called ribavirin.
Slovenian: Nekateri bolniki lahko jemljejo tudi protivirusno zdravilo, imenovano ribavirin.
English: If more than 6 hours have passed since dasabuvir is usually taken, the missed dose should NOT be taken and the patient should take the next dose per the usual dosing schedule.
Slovenian: Če je od časa, ko po navadi vzame dasabuvir, minilo že več kot 6 ur, NE SME vzeti izpuščenega odmerka, temveč mora vzeti naslednji odmerek po običajnem urniku jemanja.
English: C24:= concentration at 24 hours following single dose of cyclosporine, tacrolimus or sirolimus.
Slovenian: C24 = koncentracija merjena 24 ur po uporabi enkratnega odmerka ciklosporina, takrolimusa ali sirolimusa.
English: Sixty four of 68 (94.1%) subjects achieved SVR12.
Slovenian: Štiriinšestdeset od 68 (94,1 %) preiskovancev je doseglo SVR12.
English: HIV coinfected patients without suppressive antiretroviral therapy should not be treated with dasabuvir.
Slovenian: Bolnikov, ki so sočasno okuženi s HIV in so brez supresivnega protiretrovirusnega zdravljenja, se ne sme zdraviti z dasabuvirjem.
English: Your doctor may also give you an antiviral medicine called ribavirin.
Slovenian: Zdravnik vam lahko predpiše tudi protivirusno zdravilo, imenovano ribavirin.
English: As a precautionary measure, it is preferable to avoid the use of dasabuvir during pregnancy.
Slovenian: Iz previdnosti se je uporabi dasabuvirja med nosečnostjo bolje izogniti.
English: Potential for dasabuvir to affect the pharmacokinetics of other medicinal products In vivo drug interaction studies evaluated the net effect of the combination treatment, including ritonavir.
Slovenian: Možnost vpliva dasabuvirja na farmakokinetiko drugih zdravil V študijah medsebojnega delovanja zdravil in vivo so ocenili neto učinek kombiniranega zdravljenja,
English: Therefore, dasabuvir is not expected to affect medicinal products which are primarily excreted by the renal route via these transporters (see section 5.2).
Slovenian: Zaradi tega ni pričakovati, da bi dasabuvir vplival na zdravila, ki se v prvi vrsti izločajo skozi ledvice preko teh prenašalcev (glejte poglavje 5.2).
English: SEDATIVES / HYPNOTICS Zolpidem
Slovenian: SEDATIVI / HIPNOTIKI zolpidem
English: See also Table 2 for specific advice on raltegravir and buprenorphine which have been evaluated in drug interaction studies.
Slovenian: Glejte tudi preglednico 2 za specifičen nasvet o raltegravirju in buprenorfinu, ki sta bila ocenjena v študijah medsebojnega delovanja zdravil.
English: • If you have moderate to severe liver problems other than hepatitis C.
Slovenian: • Če imate zmerno do hudo bolezen jeter, ki ni hepatitis C.
English: NNRTIs other than rilpivirine (efavirenz, etravirine, and nevirapine) are contraindicated (see section
Slovenian: Drugi NNRTI razen rilpivirina (efavirenz, etravirin in nevirapin) so kontraindicirani (glejte poglavje
English: See additional information on specific hormonal contraceptives in sections 4.3 and 4.4.
Slovenian: Za dodatne informacije o specifičnih hormonskih kontraceptivih glejte poglavji 4.3 in 4.4.
English: Purpose of the medicine alprazolam, diazepam for anxiety, panic attacks and trouble sleeping ciclosporin, everolimus, sirolimus, tacrolimus to suppress the immune system cyclobenzaprine, carisoprodol for muscle spasms dabigatran to thin the blood deferasirox to help reduce iron levels in the blood digoxin, amlodipine for heart problems or high blood pressure furosemide for the build-up of too much fluid in the body hydrocodone for pain imatinib for the treatment of some cancers of the blood levothyroxine for thyroid problems darunavir/ritonavir, atazanavir/ritonavir, rilpivirine for HIV infection omeprazole, lansoprazole, esomeprazole for stomach ulcers and other stomach problems rosuvastatin, pravastatin, fluvastatin, pitavastatin to lower blood cholesterol s-mephenytoin for epilepsy teriflunomide for multiple sclerosis sulfasalazine to treat and manage inflammatory bowel disease or to treat rheumatoid arthritis warfarin and other similar medicines called vitamin K antagonists*
Slovenian: Alprazolam, diazepam pri tesnobi, napadih panike in težavah s spanjem ciklosporin, everolimus, sirolimus, takrolimus za zaviranje imunskega sistema ciklobenzaprin, karisoprodol pri mišičnih krčih dabigatran za redčenje krvi deferasiroks pomaga pri zmanjševanju ravni železa v krvi digoksin, amlodipin pri težavah s srcem in visokem krvnem tlaku furosemid pri prekomernem kopičenju tekočine v telesu hidrokodon proti bolečini imatinib za zdravljenje nekaterih krvnih rakov levotiroksin pri težavah s ščitnico darunavir/ritonavir, atazanavir/ritonavir, rilpivirin pri okužbah z virusom HIV omeprazol, lansoprazol, esomeprazol pri želodčnih razjedah in drugih težavah z želodcem rosuvastatin, pravastatin, fluvastatin, pitavastatin za zniževanje holesterola v krvi s-mefenitoin pri epilepsiji teriflunomid pri multipli sklerozi sulfasalazin za zdravljenje in nadziranje vnetne črevesne bolezni ali za zdravljenje revmatoidnega artritisa varfarin in druga podobna zdravila imenovana antagonisti vitamina K*
English: Dasabuvir was the predominant component observed in the milk of lactating rats, without effect on nursing pups.
Slovenian: Dasabuvir je bil glavna snov v mleku doječih podgan, brez vpliva na dojene mladiče.
English: Based on population pharmacokinetic analysis of data from Phase 3 clinical studies, a 10 year increase or decrease in age from 54 years (median age in the Phase 3 studies) would results in <10% change in dasabuvir exposures.
Slovenian: Na podlagi populacijske farmakokinetične analize podatkov kliničnih študij 3. faze bi 10-letno zvečanje ali zmanjšanje starosti od starosti 54 let (mediana starost v študijah 3. faze) povzročila < 10odstotno spremembo izpostavljenosti dasabuvirju.
English: Depression, including suicidal thoughts and behaviours, has been reported in some patients taking this medicine, particularly in patients with a prior history of depression or psychiatric illness or in patients taking ribavirin with this medicine.
Slovenian: Pri nekaterih bolnikih, ki jemljejo to zdravilo, so poročali o depresiji, vključno s samomorilnimi mislimi in vedenjem, zlasti pri bolnikih, ki so v preteklosti že imeli depresijo ali psihiatrično bolezen ali pri bolnikih, ki so s tem zdravilom jemali ribavirin.
English: Although some cases had previous history of depression, psychiatric illness and/or substance abuse, a causal relation with dasabuvir with or without ombitasvir/paritaprevir/ritonavir treatment cannot be excluded.
Slovenian: Čeprav so nekateri primeri vključevali predhodno zgodovino depresije, psihiatričnih bolezni in/ali zlorabe snovi, vzročne povezave z zdravljenjem z dasabuvirjem z ali brez ombitasvrja/paritaprevirja/ritonavirja ni mogoče izključiti.
English: In the post-liver transplant study, ribavirin dosing was individualized and most subjects received 600 to 800 mg per day (see section 5.1).
Slovenian: V študiji po presaditvi jeter je bilo odmerjanje ribavirina individualizirano in večina preiskovancev ga je prejemala od 600 do 800 mg na dan (glejte poglavje 5.1).
English: Medicinal products metabolised by CYP2D6 or CYP1A2
Slovenian: Zdravila, ki se presnovijo s CYP2D6 ali CYP1A2
English: Routine monitoring of liver enzymes is not necessary in patients that do not have cirrhosis (for cirrhotics, see above).
Slovenian: Redne kontrole jetrnih encimov niso potrebne pri bolnikih , ki nimajo ciroze jeter (za bolnike s cirozo glejte zgoraj).
English: Patient population
Slovenian: Populacija bolnikov
English: Exposures of cyclobenzaprine, a CYP1A2 substrate, were decreased.
Slovenian: Izpostavljenost ciklobenzaprina, ki je substrat CYP1A2, je bila zmanjšana.
English: Unchanged dasabuvir accounted for 26.2% and M1 for 31.5% of the total dose in faeces.
Slovenian: Na račun nespremenjenega dasabuvirja je šlo 26,2 % in na račun M1 31,5 % celotnega odmerka v blatu.
English: Patients treated with vitamin K antagonists
Slovenian: Bolniki zdravljeni z antagonisti vitamina K
English: The mean baseline haemoglobin level was 12.1 g/dL and the mean decline in haemoglobin at the end of treatment for subjects taking RBV was 1.2 g/dL.
Slovenian: Povprečna izhodiščna vrednost hemoglobina je bila 12,1 g/dl in povprečni upad hemoglobina na koncu zdravljenja pri preiskovancih, ki so jemali ribavirin, je bil 1,2 g/dl.
English: Dasabuvir is predominantly metabolised by CYP2C8 and to a lesser extent by CYP3A.
Slovenian: Biotransformacija Dasabuvir se pretežno presnovi s CYP2C8 in v manjši meri s CYP3A.
English: Resistance-associated variants at amino acid positions R155 and D168 in NS3 were rarely observed (less than 1%) at baseline.
Slovenian: Z odpornostjo povezane variante na aminokislinskih mestih R155 in D168 v NS3 so izhodiščno opažali redko (manj kot 1 %).
English: There was 1 relapse in the 12-week arm and 1 on-treatment virologic failure in the 24-week arm.
Slovenian: Bil je 1 primer recidiva v 12-tedenski skupini in 1 primer virusne neodzivnosti na zdravljenje v 24-tedenski skupini.
English: Genotype 1a N=67b % (n)
Slovenian: Genotip 1a N = 67b % (n)
English: When taking Exviera and ombitasvir/paritaprevir/ritonavir, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - Feel sick (nauseous), are sick (vomit) or lose your appetite.
Slovenian: Če zdravilo Exviera jemljete s kombinacijo ombitasvir/paritaprevir/ritonavir, obvestite svojega zdravnika, če imate naslednje simptome, ki so lahko znak poslabšanja težav z jetri: − občutite slabost (siljenje na bruhanje), bruhate ali ste izgubili apetit;
English: Impact of ribavirin dose adjustment on probability of SVR In Phase 3 clinical trials, 91.5% of subjects did not require ribavirin dose adjustments during therapy.
Slovenian: Vpliv prilagoditve odmerka ribavirina na verjetnost SVR V kliničnih preskušanjih 3. faze 91,5 % preiskovancev med zdravljenjem ni potrebovalo prilagoditve odmerka ribavirina.
English: One subject experienced relapse at Post-Treatment Week 4, 2 subjects prematurely discontinued study drug and 1 subject had missing SVR12 data.
Slovenian: Pri enem preiskovancu je prišlo do ponovitve bolezni v 4. tednu po koncu zdravljenja, 2 preiskovanca sta predčasno prenehala z jemanjem proučevanega zdravila in 1 preiskovanec je imel manjkajoč SVR12 podatek.
English: Co-administration of dasabuvir with other antivirals has not been studied and, therefore, cannot be recommended.
Slovenian: Sočasna uporaba dasabuvirja z drugimi protivirusnimi zdravili ni bila raziskana in je zato ni mogoče priporočati.
English: Treatment duration was fixed in each trial and was not guided by subjects' HCV RNA levels (no response guided algorithm).
Slovenian: Trajanje zdravljenja je bilo v vsakem preskušanju fiksno in ga niso prilagajali koncentraciji HCV RNA pri preiskovancih (algoritem brez upoštevanja odziva).
English: The most abundant plasma metabolite was M1, which represented 21% of drug-related radioactivity (AUC) in circulation following single dose; it's formed via oxidative metabolism predominantly by CYP2C8.
Slovenian: Največ je bilo v plazmi presnovka M1, ki je predstavljal 21 % z zdravilom povezane radioaktivnosti (AUC) v obtoku (AUC) po enkratnem odmerku; nastane z oksidativno presnovo, pretežno s CYP2C8.
English: Animal studies do not indicate harmful effects on fertility (see section 5.3).
Slovenian: Študije na živalih ne kažejo škodljivih učinkov na plodnost (glejte poglavje 5.3).
English: Concerning genotype-specific virological and clinical activity, see section 5.1.
Slovenian: Za virusno in klinično aktivnost, specifično za genotip, glejte poglavje 5.1.
English: Available pharmacokinetic data in animals have shown excretion of dasabuvir and metabolites in milk (see section 5.3).
Slovenian: Farmakokinetični podatki, ki so na voljo za živali, so pokazali izločanje dasabuvirja in presnovkov v mleko (glejte poglavje 5.3).
English: The maximum daily dose of rosuvastatin should be 5 mg (see section 4.4).
Slovenian: Največji dnevni odmerek rosuvastatina je lahko 5 mg (glejte poglavje 4.4).
English: • There may also be a risk for birth defects if ribavirin is taken by a male patient, whose female partner becomes pregnant.
Slovenian: • Tveganje prirojenih okvar pri novorojenčku obstaja tudi, če ribavirin jemlje bolnik, katerga partnerica zanosi.
English: Since dasabuvir is a BCRP substrate, distribution to the milk may change if this transporter is inhibited or induced by co-administration of other medicinal products.
Slovenian: Ker je dasabuvir substrat BCRP, se porazdelitev v mleko lahko spremeni, če druga sočasno uporabljena zdravila zavrejo ali inducirajo ta prenašalec.
English: The safety of dasabuvir in children and adolescents aged < 18 years has not yet been established.
Slovenian: Varnost dasabuvirja še ni ugotovljena pri otrocih in mladostnikih, starih < 18 let.
English: In the 8.5% of subjects who had ribavirin dose adjustments during therapy, the SVR rate (98.5%) was comparable to subjects who maintained their starting ribavirin dose throughout treatment.
Slovenian: Med 8,5 % preiskovancev, ki so jim med zdravljenjem prilagodili odmerek ribavirina, je bil delež SVR (98,5 %) primerljiv tistemu med preiskovanci, ki so začetni odmerek ribavirina ohranili ves čas zdravljenja.
English: Dasabuvir M1 AUC values were 6% lower, 10% lower, and 13% lower, respectively.
Slovenian: Vrednosti AUC dasabuvirja M1 pa so bile 6 %, 10 % oziroma 13 % manjše.
English: To maximise absorption, dasabuvir should be taken with food without regard to fat or calorie content.
Slovenian: Da bi bila absorpcija čim večja, je treba dasabuvir vzeti s hrano, ne glede na vsebnost maščob in kalorij.
English: M1 is mainly cleared through direct biliary excretion with the contribution of UGT-mediated glucuronidation and, to a small extent, oxidative metabolism.
Slovenian: M1 se v glavnem odstrani z neposrednim izločanjem skozi jetra s prispevkom glukuronidacije preko UGT in v manjši meri oksidativne presnove.
English: Changes in exposures of the metabolite were generally consistent with that observed with dasabuvir except for studies with CYP2C8 inhibitor, gemfibrozil, where the metabolite exposures decreased by up to 95% and CYP3A inducer, carbamazepine, where the metabolite exposures decreased by only up to 39%.
Slovenian: Spremembe v izpostavljenosti presnovku so se na splošno skladale s tistimi, ki so bile opažene z dasabuvirjem, razen v študijah z zaviralcem CYP2C8 gemfibrozilom, v katerih se je izpostavljenost presnovku zmanjšala do 95 %, in v študijah induktorja CYP3A karbamazepina, v katerih se je izpostavljenost presnovku zmanjšala le do 39 %.
English: Talk to your doctor or pharmacist before taking Exviera if you: - have liver disease other than hepatitis C; - have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Slovenian: Pred začetkom jemanja zdravila Exviera se posvetujte z zdravnikom ali farmacevtom, če: - imate tudi bolezen jeter, ki ni hepatitis C; - imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal;
English: SAPPHIRE I and II PEARL II, III, and IV TURQUOISE II (subjects with cirrhosis)
Slovenian: PEARL II, III in IV TURQUOISE II (preiskovanci s cirozo)
English: *Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.
Slovenian: *Nabor podatkov obsega vse preiskovance, okužene z genotipom 1, vključene v preskušanja 2. in 3. faze, tudi preiskovance s cirozo.
English: These ALT elevations were significantly more frequent in the subgroup of subjects who were using ethinyloestradiol -containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (6 of 25 subjects); (see section 4.3).
Slovenian: 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).
English: Similarly, dasabuvir was not carcinogenic in a 2-year rat study up to the highest dose tested (800 mg/kg/day), resulting in dasabuvir exposures approximately 19-fold higher than those in humans at 500 mg.
Slovenian: Podobno, dasabuvir ni bil kancerogen v 2-letni študiji pri podganah vse do največjega testiranega odmerka (800 mg/kg/dan), ki je povzročil približno 19-krat večjo AUC izpostavljenost dasabuvirju, kot pri človeku pri 500 mg.
English: Dasabuvir is a substrate of P-gp and BCRP and its major metabolite M1 is a substrate of OCT1 in vitro.
Slovenian: In vitro je dasabuvir substrat P-gp in BCRP in njegov glavni presnovek M1 je substrat OCT1.
English: Coadministration with ethinyloestradiol may lead to increased risk of ALT elevations (see sections 4.3 and 4.4).
Slovenian: Sočasna uporaba z etinilestradiolom lahko zveča tveganje za zvišanje ALT (glejte poglavji 4.3 in 4.4).
English: To maximise absorption, dasabuvir tablets should be taken with food, without regard to fat and calorie content (see section 5.2).
Slovenian: Da bi bila absorpcija čim večja, je treba tablete dasabuvirja vzeti s hrano, ne glede na vsebnost maščob in kalorij (glejte poglavje 5.2).
English: The combination of atazanavir and ombitasvir/paritaprevir/ ritonavir + dasabuvir increase bilirubin levels, in particular when ribavirin is part of the hepatitis C regimen, see sections 4.4 and 4.8.
Slovenian: Kombinacija atazanavirja in ombitasvir/paritap revir/ritonavir + dasabuvir zveča koncentracijo bilirubina, zlasti če je ribavirin del sheme za hepatitis C, glejte poglavji 4.4 in 4.8.
English: OATP/BCRP /P-gp inhibition by ciclosporin.
Slovenian: OATP/BCRP/Pgp s ciklosporinom.
English: Exviera tablets are beige, ovaloid film-coated tablets, of dimensions of 14.0 mm x 8.0 mm, marked with “AV2”.
Slovenian: Tablete zdravila Exviera so bež, ovaloidne filmsko obložene tablete velikosti 14,0 mm x 8,0 mm, z oznako “AV2”.
English: Bilirubin elevations were not associated with aminotransferase elevations.
Slovenian: Zvišanje bilirubina ni bilo povezano z zvišanjem aminotransferaz.
English: Not studied.
Slovenian: Ni raziskan.
English: HMG CoA REDUCTASE INHIBITOR Rosuvastatin
Slovenian: ZAVIRALEC REDUKTAZE HMG CoA rosuvastatin
English: 8 weeks may be considered in previously untreated genotype 1binfected patients with minimal to moderate fibrosis** (see section 5.1, GARNET study)
Slovenian: Pri predhodno še nezdravljenih bolnikih, okuženih z genotipom 1b in z blago do zmerno fibrozo**, se lahko razmisli o 8 tednih (glejte poglavje 5.1, študijo GARNET)
English: Concerning recommended regimens with different HCV genotypes, see section 4.2.
Slovenian: Za priporočene sheme pri različnih genotipih HCV glejte poglavje 4.2.
English: The dose of ribavirin was individualized at the discretion of the investigator, with most subjects receiving 600 to 800 mg as a starting dose, and most subjects also receiving 600 to 800 mg per day at the end of treatment.
Slovenian: Odmerek ribavirina je bil prilagojen individualno po raziskovalčevi presoji; večina bolnikov je kot začetni odmerek prejemala od 600 do 800 mg in večina preiskovancev je tudi na koncu zdravljenja prejemala od 600 do 800 mg na dan.
English: If you accidentally take more than the recommended dose, you should contact your doctor or go to the nearest hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Exviera, kot bi smeli Če ste pomotoma vzeli večji odmerek od priporočenega, takoj obvestite svojega zdravnika ali pojdite v najbližjo bolnišnico.
English: Cross-resistance
Slovenian: Navzkrižna odpornost
English: What you need to know before you take Exviera Do not take Exviera:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Exviera Ne jemljite zdravila Exviera: