FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited data in patients with end-stage renal disease indicate no clinically significant changes in exposure also in this patient group.
Slovenian: Omejeni podatki pri bolnikih s končno ledvično odpovedjo ne kažejo nobenih klinično pomembnih sprememb pri izpostavitvi tudi pri tej skupini bolnikov.
English: Expected:
Slovenian: Pričakovano:
English: Although causality is difficult to establish due to background advanced liver disease, a potential risk cannot be excluded.
Slovenian: Čeprav je vzročnost zaradi obstoječe napredovale bolezni jeter težko dokazati, možnega tveganja ni mogoče izključiti.
English: Overall, 61% had fibrosis stage F0-F1, 26% F2, 9% F3, and 4% F4.
Slovenian: Celokupno jih je 61 % imelo fibrozo stopnje F0-F1, 26 % F2, 9 % F3 in 4 % F4.
English: Medicinal Product/ Possible Mechanism of Interaction
Slovenian: Zdravilo/možni mehanizem medsebojnega delovanja
English: Do not stop taking Exviera unless your doctor tells you to.
Slovenian: Ne prenehajte jemati zdravila Exviera, razen če vam to naroči zdravnik.
English: No (for any parameter listed above) *AFP= serum alpha fetoprotein
Slovenian: Ne (za kateri koli zgoraj našteti parameter) *AFP = alfa-fetoprotein v serumu
English: • Swallow the tablets whole with water.
Slovenian: • Tablete pogoltnite cele z vodo.
English: There are some medicines you must not take with Exviera - see the previous table “Medicines you must not take with Exviera”.
Slovenian: Obstajajo nekatera zdravila, ki jih ne smete jemati z zdravilom Exviera - glejte prejšnjo preglednico “Zdravila, ki jih ne smete jemati z zdravilom Exviera”.
English: Take one tablet in the morning.
Slovenian: Vzemite eno tableto zjutraj.
English: All clinical trials with dasabuvir have been conducted following administration with food.
Slovenian: Vsa klinična preskušanja z dasabuvirjem so bila izvedena po uporabi s hrano.
English: The adverse reactions are listed below by system organ class and frequency.
Slovenian: Neželeni učinki so navedeni spodaj po organskem sistemu in pogostnosti.
English: NA Decrease in amlodipine dose by 50% and monitor patients for clinical effects.
Slovenian: NP Priporočljivo je zmanjšanje odmerka amlodipina za 50 % in kontroliranje bolnikov glede kliničnih učinkov.
English: Exviera tablets are packed into foil blisters containing 2 tablets.
Slovenian: Tablete zdravila Exviera so pakirane v pretisne omote, ki vsebujejo 2 tableti.
English: Frequencies are defined as follows: 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) or very rare (<1/10,000).
Slovenian: Opredelitev pogostnosti je: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000
English: Thirty-nine of the 50 subjects who received ribavirin required interruption of ribavirin, and 11 of these subjects were also treated with erythropoietin.
Slovenian: Devetintrideset od 50 preiskovancev, ki so prejemali ribavirin, je potrebovalo prekinitev jemanja ribavirina, od teh je 11 preiskovancev bilo zdravljenih tudi z eritropoetinom.
English: Do not use the medicine after the expiry date which is stated on the carton after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake ‘EXP'.
English: b. N=66 for the NS5B target.
Slovenian: b. N = 66 za tarčni gen NS5B.
English: • Less than 6 hours until your next dose - do not take the missed dose, take your next dose as usual with food.
Slovenian: • manj kot 6 ur do naslednjega odmerka - ne vzemite pozabljenega odmerka, ampak vzemite naslednji odmerek kot običajno s hrano.
English: Tell your doctor if you have a history of depression or psychiatric illness.
Slovenian: Povejte svojemu zdravniku, če ste v preteklosti imeli depresijo ali psihiatrično bolezen.
English: The safety and efficacy of dasabuvir in children less than 18 years of age have not been established.
Slovenian: Varnost in učinkovitost dasabuvirja nista ugotovljeni pri otrocih, mlajših od 18 let.
English: Rilpivirine should be used cautiously, in the setting of repeated ECG monitoring.
Slovenian: Rilpivirin je treba uporabljati previdno in ob ponavljajočih se kontrolah EKG.
English: Main demographics in TURQUOISE-III Characteristics
Slovenian: Preglednica 15: Glavne demografske značilnosti v TURQUOISE-III
English: Your doctor will talk with you about which of these medicines to take with Exviera.
Slovenian: Zdravnik se bo z vami pogovoril o tem, katero od teh dveh zdravil boste jemali z zdravilom Exviera.
English: Everolimus cannot be used due to lack of suitable dose strengths for dose adjustments.
Slovenian: Everolimus se ne sme uporabiti zaradi pomanjkanja ustreznih jakosti odmerka za prilagoditve le tega.
English: Raltegravir exposure is substantially increased (2-fold).
Slovenian: Izpostavljenost raltegravirju se bistveno zveča (2-krat).
English: Q80K, although a highly prevalent polymorphism in NS3 (41.2% of samples), confers minimal resistance to paritaprevir.
Slovenian: Q80K je sicer zelo razširjen polimorfizem NS3 (41,2 % vzorcev), vendar povzroča minimalno odpornost proti paritaprevirju.
English: The interactions with pitavastatin and fluvastatin have not been investigated.
Slovenian: Medsebojnega delovanja s pitavastatinom in fluvastatinom niso raziskana.
English: Mechanism:
Slovenian: Mehanizem:
English: Contraceptive medicines that contains ethinyloestradiol cannot be used in combination with Exviera.
Slovenian: Zdravila za kontracepcijo, ki vsebujejo etinilestradiol, se ne smejo uporabljati v kombinaciji z zdravilom Exviera.
English: Seven metabolites were identified in plasma.
Slovenian: V plazmi so ugotovili sedem presnovkov.
English: Caution should be used in patients with a pre-existing history of depression or psychiatric illness.
Slovenian: Previdnost je potrebna pri bolnikih z že obstoječo zgodovino depresije ali psihiatričnih bolezni.
English: Elimination half-life in rat milk was slightly shorter than in plasma, AUC was about 2 fold of that in plasma.
Slovenian: Razpolovni čas izločanja iz mleka podgan je bil rahlo krajši kot iz plazme in AUC je bila približno 2-krat tolikšna kot v plazmi.
English: Your doctor will test your blood before, during and after your treatment with Exviera.
Slovenian: Vaš zdravnik bo opravil krvne preiskave pred in med zdravljenjem z zdravilom Exviera ter po njem.
English: Dasabuvir exposures increased in a dose proportional manner and accumulation is minimal.
Slovenian: Izpostavljenost dasabuvirju se je povečevala sorazmerno odmerku in kopičenje je minimalno.
English: See the section on contraception below.
Slovenian: Glejte poglavje o kontracepciji v nadaljevanju.
English: G558R and D559G/N were observed as treatment-emergent substitutions but the activity of dasabuvir against these variants could not be evaluated due to poor replication capacity.
Slovenian: G558R in D559G/N so opažali kot med zdravljenjem nastali substituciji, toda aktivnosti dasabuvirja proti tema variantama zaradi slabe replikacijske sposobnosti niso ocenili.
English: • Confirm if your treatment has worked and if you are free of the hepatitis C virus.
Slovenian: • potrdi, ali je bilo zdravljenje pri vas uspešno in nimate več virusa hepatitisa C;
English: Part 1 of the study was a Phase 2 pilot cohort consisting of 2 parts, Part 1a (63 subjects) and Part 1b (22 subjects).
Slovenian: Prvi del študije je bila pilotna faza 2, sestavljena iz 2 delov; dela 1a (63 preiskovancev) in dela 1b (22 preiskovancev).
English: Changes for dasabuvir and ombitasvir, paritaprevir are the same as shown for paracetamol above
Slovenian: Spremembe za dasabuvir in ombitasvir, paritaprevir so enake kot tiste prikazane za paracetamol zgoraj.
English: A total of 129 subjects were treated, 84 with GT1a, 41 with GT1b, 1 with GT1 other, 3 with GT4 infection.
Slovenian: Zdravljenih je bilo 129 preiskovancev, 84 z GT1a, 41 z GT1b, 1 z drugim GT1 in 3 z GT4 okužbo.
English: This will give the medicines the best chance to clear the hepatitis C virus infection.
Slovenian: Tako bodo možnosti, da zdravila ozdravijo okužbo z virusom hepatitisa C, najboljše.
English: It is very important that you also read the package leaflets for the other antiviral medicines that you take with Exviera.
Slovenian: Pomembno je, da preberete tudi navodila za uporabo drugih protivirusnih zdravil, ki jih jemljete z zdravilom Exviera.
English: Part 2 was a Phase 3 cohort consisting of 233 subjects.
Slovenian: Drugi del študije je bila faza 3, sestavljena iz 233 preiskovancev.
English: The recommended tacrolimus dosing is 0.5 mg every 7 days.
Slovenian: Priporočljivo odmerjanje takrolimusa je 0,5 mg vsakih 7 dni.
English: • Risk management plan (RMP)
Slovenian: ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
English: C12:= concentration at 12 hours following single dose of everolimus.
Slovenian: C12 = koncentracija merjena 12 ur po uporabi enkratnega odmerka everolimusa.
English: Exviera should not be used during pregnancy or in women of childbearing potential not using effective contraception.
Slovenian: Zdravilo Exviera se ne sme uporabljati med nosečnostjo ali pri ženskah v rodni dobi brez učinkovite kontracepcije.
English: • efavirenz, nevirapine, etravirine
Slovenian: • efavirenz, nevirapin, etravirin
English: Ribavirin dose modification did not impact SVR rates.
Slovenian: Prilagoditev odmerka ribavirina ni vplivala na deleže SVR.
English: • Monitoring should be performed for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage).
Slovenian: • potrebna je kontrola glede kliničnih znakov in simptomov dekompenzacije jeter (kot so ascites, jetrna encefalopatija, krvavitev iz varic),
English: You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.
Slovenian: Vi ali vaš oskrbnik morate nemudoma obvestiti vašega zdravnika o kakršnih koli spremembah v vedenju ali razpoloženju in o morebitnih samomorilnih mislih.
English: • Feeling weak or lack of energy (asthenia).
Slovenian: • občutek šibkosti ali pomanjkanja energije (astenija) • driska.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo bolnika kontrolirati glede znakov in simptomov neželenih učinkov in nemudoma je treba uvesti ustrezno simptomatsko zdravljenje.
English: a herbal medicine for anxiety and mild depression.
Slovenian: zdravilo rastlinskega izvora za zdravljenje tesnobe in blage depresije.
English: The lack of detection of virus containing a resistance-associated substitution does not indicate that the resistant virus is no longer present at clinically significant levels.
Slovenian: Nezaznava virusa, ki je nosilec z odpornostjo povezane substitucije, ne pomeni, da odporni virus ni več prisoten v klinično pomembni koncentraciji.
English: Pitavastatin and fluvastatin
Slovenian: Pitavastatin in fluvastatin
English: In case a dose of dasabuvir is missed, the prescribed dose can be taken within 6 hours.
Slovenian: Če bolnik izpusti odmerek dasabuvirja, lahko predpisani odmerek vzame v 6 urah.
English: Four subjects experienced a haemoglobin level < 8 g/dL.
Slovenian: Štirje preiskovanci so imeli raven hemoglobina < 8 g/dl.
English: Pharmacotherapeutic group: Antivirals for systemic use; direct-acting antivirals, ATC code: J05AP09
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse; oznaka ATC: J05AP09
English: Treatment with dasabuvir should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Slovenian: Zdravljenje z dasabuvirjem mora uvesti in nadzirati zdravnik, ki ima izkušnje z vodenjem kroničnega hepatitisa C.
English: 14 film-coated tablets Component of a multipack, can't be sold separately.
Slovenian: 14 filmsko obloženih tablet Komponente večkratnega pakiranja se ne sme izdati posebej.
English: Other medicines and Exviera
Slovenian: Druga zdravila in zdravilo Exviera
English: HBV screening should be performed in all patients before initiation of treatment.
Slovenian: Pri vseh bolnikih je treba pred začetkom zdravljenja izvesti presejanje za HBV .
English: R-warfarin
Slovenian: R-varfarin
English: Do not give Exviera to children and adolescents under 18 years of age.
Slovenian: Ne dajajte zdravila Exviera otrokom in mladostnikom, mlajšim od 18 let.
English: A decrease in alprazolam dose can be considered based on clinical response.
Slovenian: V poštev pride zmanjšanje odmerka alprazolama glede na klinični odziv.
English: Elevations in ALT were generally not associated with bilirubin elevations.
Slovenian: Zvišanja ALT običajno niso bila povezana z zvišanjem bilirubina.
English: Overall SVR12
Slovenian: Celotni SVR12
English: Cmax (ng/ml) (CV%)
Slovenian: Cmax (ng/ml) (KV %)
English: A 10 kg change in body weight from 76 kg (median weight in the Phase 3 studies) would result in <10% change in dasabuvir exposures.
Slovenian: Sprememba telesne mase za 10 kg od telesne mase 76 kg (mediana telesna masa v študijah 3. faze) bi povzročila < 10-odstotno spremembo izpostavljenosti dasabuvirju.
English: • apalutamide, enzalutamide
Slovenian: • apalutamid, enzalutamid
English: In addition, M1 is a substrate of the hepatic uptake transporters OATP family and OCT1 and thus, the hepatocyte concentration and thereby contribution to efficacy, may be larger than dasabuvir.
Slovenian: Poleg tega je M1 substrat prenašalcev jetrnega prevzema družine OATP in OCT1 in je tako lahko koncentracija hepatocitov ter s tem prispevek k učinkovitosti večji kot pri dasabuvirju.
English: Treatment-emergent variants and their prevalence in these virologic failure populations are shown in Table 5.
Slovenian: Med zdravljenjem nastale variante in njihova prevalenca v teh populacijah z virusno neodzivnostjo so prikazane v preglednici 5.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: Dasabuvir must not be administered as monotherapy.
Slovenian: Dasabuvir se ne sme uporabljati kot monoterapija.
English: Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System (except GARNET which used COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
Slovenian: Koncentracijo HCV RNA v plazmi so v kliničnih preskušanjih merili s testom COBAS TaqMan HCV test (verzija 2.0), ki je namenjen za uporabo s sistemom High Pure System (razen pri GARNET študiji, kjer so uporabili COBAS AmpliPrep/COBAS TaqMan HCV test v2.0).
English: There are very limited data from the use of dasabuvir in pregnant women.
Slovenian: Podatki o uporabi dasabuvirja pri nosečnicah so zelo omejeni.
English: Such medicinal products include sulfasalazine, imatinib and some of the statins (see Table 2).
Slovenian: Med takšnimi zdravili so sulfasalazin, imatinib in nekateri statini (glejte preglednico 2).
English: Paediatric population Drug interaction studies have only been performed in adults.
Slovenian: Študije medsebojnega delovanja so bile izvedene le pri odraslih.
English: Outcome for subjects without SVR12
Slovenian: Izid pri preiskovancih brez SVR12
English: The changes in dasabuvir exposures in subjects with mild, moderate and severe renal impairment are not considered to be clinically significant.
Slovenian: Spremembe izpostavljenosti dasabuvirju pri preiskovancih z blago, zmerno in hudo okvaro ledvic ne veljajo za klinično pomembne.
English: Extra precautions are needed if Exviera is taken together with ribavirin.
Slovenian: Posebna previdnost je potrebna, če se zdravilo Exviera jemlje skupaj z ribavirinom.
English: The film-coated tablets are for oral use.
Slovenian: Način uporabe Filmsko obložene tablete so namenjene za peroralno uporabo.
English: The efficacy of dasabuvir in patients previously exposed to dasabuvir, or to medicinal products anticipated to be cross-resistant, has not been demonstrated.
Slovenian: Učinkovitost dasabuvirja ni dokazana pri bolnikih, predhodno izpostavljenih dasabuvirju ali zdravilom, za katere je pričakovana navzkrižna odpornost.
English: Dasabuvir is highly bound to plasma proteins.
Slovenian: Dasabuvir je v zelo veliki meri vezan na beljakovine v plazmi.
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines.
Slovenian: Pri bolnikih s sočasno okužbo s HBV/HCV obstaja tveganje za reaktivacijo HBV, zato jih je treba spremljati in zdraviti po trenutno veljavnih kliničnih smernicah.
English: Effect of baseline HCV substitutions/polymorphisms on treatment response
Slovenian: Vpliv izhodiščnih substitucij/polimorfizmov HCV na odziv na zdravljenje
English: Male patients and their female partners: Either male patients or their female partners of childbearing potential must use a form of effective contraception during treatment with ribavirin and for 7 months after treatment.
Slovenian: Bolniki in njihove partnerice: Bolniki oz. njihove partnerice, ki so v rodni dobi, morajo uporabljati učinkovito obliko kontracepcije med zdravljenjem z ribavirinom in še 7 mesecev po njem.
English: Exviera is an antiviral medicine used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Slovenian: Zdravilo Exviera je protivirusno zdravilo, ki se uporablja za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C (nalezljiva bolezen, ki prizadane jetra in jo povzroča virus hepatitisa C).
English: What Exviera is and what it is used for
Slovenian: Kaj je zdravilo Exviera in za kaj ga uporabljamo
English: Treatment of patients with HIV co-infection
Slovenian: Zdravljenje bolnikov, sočasno okuženih s HIV
English: GARNET (open-label)
Slovenian: GARNET (odprta)
English: AUC (ng*hr/ml) (CV%)
Slovenian: AUC (ng*hr/ml) (KV %)
English: Women of childbearing potential /contraception in males and females
Slovenian: Ženske v rodni dobi/kontracepcija pri moških in ženskah
English: Examples of contraindicated inducers are provided below.
Slovenian: Primeri kontraindiciranih induktorjev so navedeni spodaj.
English: No human data on the effect of dasabuvir on fertility are available.
Slovenian: Podatkov o vplivu dasabuvirja na plodnost pri človeku ni.
English: Examples of contraindicated CYP2C8 inhibitors are provided below.
Slovenian: Primeri kontraindiciranih zaviralcev CYP2C8 so navedeni spodaj.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Slovenian: Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with dasabuvir, 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 dasabuvirjem, 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: The frequency of indirect bilirubin elevations was lower among subjects who did not receive ribavirin.
Slovenian: Zvišanje indirektnega bilirubina je bilo manj pogosto med preiskovanci, ki niso dobivali ribavirina.
English: The blood to plasma concentration ratios in human ranged from 0.5 to 0.7 indicating that dasabuvir was preferentially distributed in the plasma compartment of whole blood.
Slovenian: Razmerje med koncentracijo v krvi in plazmi je pri človeku segalo od 0,5 do 0,7; to kaže, da se dasabuvir v prvi vrsti porazdeli v plazemskem razdelku polne krvi.
English: Clinical monitoring and lower doses of imatinib are recommended.
Slovenian: Priporočljivo je klinično spremljanje in manjši odmerki imatiniba.
English: Changes in selected laboratory parameters are described in Table 4.
Slovenian: Laboratorijske nepravilnosti Spremembe izbranih laboratorijskih vrednosti so opisane v preglednici 4.
English: Dasabuvir is a non-nucleoside inhibitor of the HCV RNA-dependent RNA polymerase encoded by the NS5B gene, which is essential for replication of the viral genome.
Slovenian: Dasabuvir je nenukleoziden zaviralec od RNA-odvisne RNA-polimeraze HCV, kodirane z genom NS5B, ki je nujna za replikacijo virusnega genoma.
English: Exviera works by stopping the hepatitis C virus from multiplying and infecting new cells, thus clearing the virus from your blood over a period of time.
Slovenian: Zdravilo Exviera deluje tako, da ustavi razmnoževanje virusa hepatitisa C in okužbo novih celic ter v določenem časovnem obdobju odstrani virus iz krvi.
English: Food increased the exposure (AUC) of dasabuvir by up to 30% relative to the fasting state.
Slovenian: V primerjavi s stanjem na tešče je hrana zvečala izpostavljenost (AUC) dasabuvirju za do 30 %.
English: The recommended dose is 250 mg of dasabuvir (one tablet) twice daily (morning and evening).
Slovenian: Priporočeni peroralni odmerek dasabuvirja je 250 mg (ena tableta) dvakrat na dan (zjutraj in zvečer).
English: See also Table 2 for specific advice on rosuvastatin which has been evaluated in a drug interaction study.
Slovenian: Glejte tudi preglednico 2 za specifičen nasvet o rosuvastatinu, ki je bil ocenjen v študiji medsebojnega delovanja zdravil.
English: Lower ribavirin dose at initiation may be appropriate.
Slovenian: Na začetku je lahko primeren manjši odmerek ribavirina.
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, and AUC) in the paritaprevir, ombitasvir, dasabuvir and the co-administered medicinal product (↑= increase more than 20%, ↓ = decrease more than 20%, ↔ = no change or change less than 20%).
Slovenian: Smer puščice kaže smer spremembe izpostavljenosti (Cmax, AUC in Cmin) paritaprevirju, ombitasvirju, dasabuvirju in sočasno uporabljenemu zdravilu (↑ = zvečanje za več kot 20 %, ↓ = zmanjšanje za več kot 20 %, ↔ = brez spremembe ali sprememba manj kot 20 %).
English: The overall safety profile in subjects with severe renal impairment was similar to that seen in prior Phase 3 studies in subjects without severe renal impairment, except that a greater proportion of subjects required intervention due to ribavirin-associated decreases in serum haemoglobin.
Slovenian: Celotni varnostni profil pri preiskovancih s hudo okvaro ledvic je bil podoben kot pri predhodnih študijah 3. faze pri preiskovancih brez hude okvare ledvic, z izjemo tega, da je večji del preiskovancev potreboval posredovanje zaradi z ribavirinom povezanih zmanjšanj hemoglobina v serumu.
English: Dasabuvir M1 metabolite was quantified in all the drug interaction studies.
Slovenian: Presnovek dasabuvirja M1 so kvantificirali v vseh študijah medsebojnega delovanja zdravil.
English: Severe renal impairment or ESRD includes CKD Stage 4 defined as eGFR <30-15 mL/min/1.73 m2 or CKD Stage 5 defined as <15 mL/min/1.73 m2 or requiring haemodialysis.
Slovenian: Huda okvara ledvic ali končna ledvična odpoved vključuje CKD 4. stopnje, definirane kot eGFR <3015 ml/min/1,73 m2, ali CKD 5. stopnje, definirane kot <15 mL/min/1,73 m2 ali če je potrebna hemodializa.
English: Because of the potential for adverse reactions from the medicinal product in breastfed infants, a decision must be made whether to discontinue breastfeeding or discontinue treatment with dasabuvir, taking into account the importance of the therapy to the mother.
Slovenian: Ker ima zdravilo lahko neželene učinke na dojene otroke, se je treba odločiti, ali naj ženska prekine dojenje ali zdravljenje z dasabuvirjem, pri čemer je treba upoštevati pomen zdravljenja za mater.