FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of isolates tested: a=5, b=4, c=14, d=10, e=9
Slovenian: Število testiranih izolatov: a = 5, b = 4, c = 14, d = 10, e = 9
English: Changes in selected laboratory parameters are described in Table 4.
Slovenian: Spremembe izbranih laboratorijskih parametrov so opisane v preglednici 4.
English: • Do not take a double dose (two doses together) to make up for a forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka (dveh odmerkov skupaj), če ste pozabili vzeti prejšnji odmerek.
English: Additional Study Details
Slovenian: Dodatne podrobnosti o študiji
English: • sunitinib to treat certain cancers
Slovenian: • sunitinib za zdravljenje določenih vrst raka,
English: 12 Weeks
Slovenian: 12 tednov
English: Table 2 provides a listing of assessed or potential medicinal product interactions.
Slovenian: Preglednica 2 prikazuje seznam ocenjenih ali možnih medsebojnih delovanj z zdravili.
English: It is important not to miss a dose of this medicine.
Slovenian: Pomembno je, da ne izpustite nobenega odmerka tega zdravila.
English: Hepatitis C is a virus that infects the liver.
Slovenian: Virus hepatitisa C je virus, ki okuži jetra.
English: Population Study Arms and Duration (Number of Subjects Treated)
Slovenian: Populacija Študijske skupine in trajanje (število zdravljenih preiskovancev)
English: GT = Genotype
Slovenian: GT = genotip
English: The recommended dose is one tablet once a day with or without food.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan s hrano ali brez nje.
English: The tablet is 21 mm long and 10 mm wide.
Slovenian: Tableta je dolga 21 mm in široka 10 mm.
English: Your doctor may have to change your medicines or change the dose of your medicines.
Slovenian: Zdravnik vam bo morda moral zamenjati zdravila oziroma spremeniti odmerke zdravil.
English: • have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely
Slovenian: • imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal,
English: Do not stop taking this medicine unless your doctor tells you to.
Slovenian: Ne prenehajte jemati tega zdravila, razen če vam tako svetuje zdravnik.
English: • have ever taken any medicine for hepatitis C
Slovenian: • ste kdaj jemali katero koli zdravilo za hepatitis C,
English: ZEPATIER (administered alone or in combination with ribavirin) is not likely to have an effect on the ability to drive and use machines.
Slovenian: Zdravilo ZEPATIER (uporabljeno samo ali v kombinaciji z ribavirinom) verjetno ne bo imelo vpliva na sposobnost vožnje in upravljanja strojev.
English: Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
Slovenian: Vodite seznam svojih zdravil in ga pokažite zdravniku in farmacevtu, kadar dobite kakšno novo zdravilo.
English: There are no adequate and well-controlled studies with ZEPATIER in pregnant women.
Slovenian: Ustreznih in dobro nadzorovanih študij z zdravilom ZEPATIER pri nosečnicah ni.
English: The active substances in the medicine work together by blocking two different proteins that the hepatitis C virus needs to grow and reproduce.
Slovenian: Učinkovini v zdravilu delujeta skupaj in blokirata dve različni beljakovini, ki ju virusi hepatitisa C potrebujejo za rast in razmnoževanje.
English: • It is very important that you read the information concerning pregnancy and contraception in the ribavirin package leaflet very carefully.
Slovenian: • Zelo pomembno je, da natančno preberete informacije o nosečnosti in kontracepciji v navodilu za uporabo ribavirina.
English: ZEPATIER is not recommended in patients infected with these genotypes.
Slovenian: Zdravilo ZEPATIER ni priporočljivo za bolnike, okužene s temi genotipi.
English: The recommended dose is one tablet once daily.
Slovenian: Priporočeni odmerek je ena tableta na dan.
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: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) ali zelo redki (< 1/10.000).
English: This includes herbal medicines and medicines obtained without a prescription.
Slovenian: To velja tudi za zdravila rastlinskega izvora in zdravila, ki ste jih dobili brez recepta.
English: Table 8: Studies conducted with ZEPATIER
Slovenian: Preglednica 8: Študije, izvedene z zdravilom ZEPATIER
English: For elbasvir, the absolute bioavailability is estimated to be 32%.
Slovenian: Ocenjujejo, da je absolutna biološka uporabnost elbasvirja 32 %.
English: • you are allergic to elbasvir, grazoprevir or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na elbasvir, grazoprevir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: These late ALT elevations were typically asymptomatic.
Slovenian: Ta zakasnela zvišanja ALT so bila praviloma asimptomatska.
English: Treatment and duration
Slovenian: Zdravljenje in trajanje zdravljenja
English: The film-coated tablets should be swallowed whole and may be taken with or without food (see section 5.2).
Slovenian: Filmsko obložene tablete je treba pogoltniti cele in se jih lahko vzame s hrano ali brez nje (glejte poglavje 5.2).
English: This means you and your partner must take special precautions in sexual activity if there is any chance you or your partner could become pregnant.
Slovenian: Vi in vaša partnerka morata biti zato pri spolnih odnosih posebej pazljiva, če obstaja kakršna koli možnost za zanositev.
English: It is very important that you also read the leaflets for the other medicines that you will be taking with ZEPATIER.
Slovenian: Zelo pomembno je, da preberete tudi navodilo za uporabo drugega zdravila, ki ga boste jemali skupaj z zdravilom ZEPATIER.
English: The effects of ZEPATIER in pregnancy are not known.
Slovenian: Učinki zdravila ZEPATIER med nosečnostjo niso znani.
English: The potential for grazoprevir to be a breast cancer resistance protein (BCRP) substrate cannot be excluded.
Slovenian: Možnosti, da je grazoprevir substrat za protein odpornosti pri raku dojke (BCRP - breast cancer resistance protein), ni mogoče izključiti.
English: • check if your treatment has worked and you are free of hepatitis C
Slovenian: • da preveri, ali je zdravljenje pri vas delovalo in nimate več hepatitisa C,
English: • rosuvastatin, atorvastatin, fluvastatin, simvastatin, or lovastatin, for lowering blood cholesterol
Slovenian: • rosuvastatin, atorvastatin, fluvastatin, simvastatin ali lovastatin za znižanje holesterola v krvi,
English: ALT (IU/L) 5.1-10.0 × ULN
Slovenian: ALT (i.e./l) 5,1-10,0 × ZNM
English: Aluminium or magnesium hydroxide; calcium carbonate
Slovenian: Aluminijev ali magnezijev hidroksid; kalcijev karbonat
English: The efficacy of ZEPATIER has not been demonstrated in HCV genotypes 2, 3, 5 and 6.
Slovenian: Učinkovitost zdravila ZEPATIER pri genotipih HCV 2, 3, 5 in 6 ni bila dokazana.
English: An up “↑” or down “↓” arrow represents a change in exposure that requires monitoring or a dose adjustment of that medication, or the co-administration is not recommended or contraindicated.
Slovenian: Puščica navzgor "↑" oziroma puščica navzdol "↓" predstavljata spremembo izpostavljenosti, ki zahteva spremljanje ali prilagoditev odmerka tega zdravila, ali da sočasna uporaba ni priporočljiva oziroma je kontraindicirana.
English: Your doctor will tell you how many weeks you should take ZEPATIER for.
Slovenian: Zdravnik vam bo povedal, koliko tednov morate jemati zdravilo ZEPATIER.
English: This will give the medicine the best chance to treat your hepatitis C infection.
Slovenian: Tako boste imeli najboljše možnosti, da vam zdravilo ozdravi okužbo s hepatitisom C.
English: STIMULANTS
Slovenian: STIMULANSI
English: If vomiting occurs more than 4 hours after dosing, no further dose is needed.
Slovenian: Če se bruhanje pojavi več kot 4 ure po zaužitju zdravila, dodaten odmerek ni potreben.
English: Embryo fetal and post natal development
Slovenian: Embrio-fetalni in postnatalni razvoj
English: Mean ratio (90 % confidence interval) for AUC, Cmax, C12 or C24 (likely mechanism of interaction)
Slovenian: Povprečno razmerje (90 % interval zaupanja) za AUC, Cmax, C12 ali C24 (verjeten mehanizem medsebojnega delovanja)
English: • have any other medical conditions.
Slovenian: • imate kakršno koli drugo bolezen.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Slovenian: V primeru prevelikega odmerjanja je priporočljivo bolnika spremljati glede znakov in simptomov neželenih učinkov in uvesti ustrezno simptomatsko zdravljenje.
English: In clinical studies, the most commonly reported adverse reactions (greater than 10%) were fatigue and headache.
Slovenian: V kliničnih študijah sta bila najpogostejša neželena učinka (več kot 10 %) utrujenost in glavobol.
English: See list under “Do not take ZEPATIER if you are taking any of the following medicines.”
Slovenian: Za seznam teh zdravil glejte "Ne jemljite zdravila ZEPATIER, če jemljete katero od naslednjih zdravil."
English: Because reproduction animal studies are not always predictive of human response, ZEPATIER should be used only if the potential benefit justifies the potential risk to the fetus.
Slovenian: Ker študije o sposobnosti razmnoževanja na živalih ne napovejo vedno tudi odziva pri človeku, se zdravilo ZEPATIER med nosečnostjo lahko uporabi le, če možna korist upravičuje morebitno tveganje za plod.
English: Population pharmacokinetics estimates of exposure of elbasvir and grazoprevir were comparable between Whites and Black/African Americans.
Slovenian: Populacijske farmakokinetične ocene izpostavljenosti elbasvirju in grazoprevirju so bile med belci in črnci/Afroameričani primerljive.
English: • feeling weak or lack of energy (asthenia)
Slovenian: • občutek šibkosti ali pomanjkanje energije (astenija)
English: Animal studies do not indicate harmful effects with respect to reproductive toxicity.
Slovenian: Študije na živalih ne kažejo škodljivih učinkov na sposobnost razmnoževanja.
English: Do not use the medicine after the expiry date which is stated on the carton and blister packaging after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
English: • you have certain moderate or severe liver problems
Slovenian: • če imate zmerne ali hude težave z jetri.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ZEPATIER therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom ZEPATIER, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Reference
Slovenian: Referenca
English: The long-term clinical impact of the emergence or persistence of virus containing ZEPATIER resistance-associated substitutions is unknown.
Slovenian: Dolgoročni klinični vpliv pojava oziroma trajnosti z odpornostjo na zdravilo ZEPATIER povezanih substitucij, ki vsebujejo virus, ni znan.
English: Talk to your doctor about different contraception methods that are suitable for you.
Slovenian: Z zdravnikom se posvetujte o primernih načinih kontracepcije.
English: The adverse reactions are listed below by body system organ class and frequency.
Slovenian: Neželeni učinki so navedeni po organskem sistemu in pogostnosti.
English: Table 2: Interactions and dose recommendations with other medicinal products
Slovenian: Preglednica 2: Medsebojno delovanje in priporočila glede odmerkov med uporabo z drugimi zdravili
English: This is so your doctor can:
Slovenian: To mu bo omogočilo:
English: Wait and take your next dose at your usual time.
Slovenian: Počakajte in vzemite naslednji odmerek ob običajnem času jemanja.
English: Includes subjects with virologic breakthrough.
Slovenian: Vključuje preiskovance z virološkim prebojem.
English: • have diabetes.
Slovenian: • imate sladkorno bolezen.
English: The rate of late ALT elevations during treatment is directly related to the plasma exposure to grazoprevir.
Slovenian: Deleži zakasnelega zvišanja ALT med zdravljenjem so neposredno povezani s plazemsko izpostavljenostjo grazoprevirju.
English: If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Do not chew, crush or split the tablet.
Slovenian: Tablet ne žvečite, drobite ali prelamljajte.
English: Patients should be informed that fatigue has been reported during treatment with ZEPATIER (see section 4.8).
Slovenian: Bolnike je treba obvestiti, da so med zdravljenjem z zdravilom ZEPATIER poročali o utrujenosti (glejte poglavje 4.8).
English: Each carton contains a total of 28 tablets.
Slovenian: Ena škatla vsebuje skupaj 28 tablet.
English: These differences in elbasvir and grazoprevir exposure are not clinically relevant; therefore, elbasvir/grazoprevir may be taken without regard to food.
Slovenian: Te razlike v izpostavljenosti elbasvirju in grazoprevirju klinično niso pomembne, zato se lahko elbasvir/grazoprevir jemlje ne glede na hrano.
English: What ZEPATIER is and what it is used for
Slovenian: Kaj je zdravilo ZEPATIER in za kaj ga uporabljamo
English: Store in the original package until use to protect from moisture.
Slovenian: Do uporabe shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago.
English: • decide what other medicines you should take with ZEPATIER and for how long
Slovenian: • da se odloči, katera druga zdravila morate jemati skupaj z zdravilom ZEPATIER in koliko časa,
English: If you do miss a dose, work out how long it is since you should have taken ZEPATIER:
Slovenian: Če pozabite vzeti odmerek, izračunajte, koliko časa je minilo od takrat, ko bi morali vzeti zdravilo ZEPATIER:
English: Multi-arm, multi-stage study.
Slovenian: Večstopenjska študija z več skupinami.
English: This is due to liver function changes during treatment with ZEPATIER.
Slovenian: Razlog za to so spremembe delovanja jeter pri zdravljenju z zdravilom ZEPATIER.
English: These late ALT elevations generally occurred at or after treatment week 8.
Slovenian: Zakasnela zvišanja ALT so se po navadi pojavila v 8. tednu zdravljenja ali kasneje.
English: Overall SVR
Slovenian: Celokupni SVR
English: In these healthy volunteer studies, adverse reactions were similar in frequency and severity to those reported in the placebo groups.
Slovenian: V teh študijah pri zdravih prostovoljcih so bili neželeni učinki po pogostnosti in izrazitosti podobni kot v skupinah s placebom.
English: Includes subjects with baseline sequencing data and who either achieved SVR12 or met criteria for virologic failure.
Slovenian: Vključuje preiskovance, pri katerih so na voljo podatki o izhodiščnem sekvenciranju, in ki so dosegli SVR12 oziroma ustrezali kriterijem za virološki neuspeh.
English: Includes four subjects infected with genotype 1 subtypes other than 1a or 1b.
Slovenian: Vključuje štiri preiskovance, okužene z drugimi podtipi genotipa 1, razen 1a in 1b.
English: Nervous system disorders: Very common headache
Slovenian: Bolezni živčevja: Zelo pogosti glavobol
English: ZEPATIER + RBV, 16 Weeks
Slovenian: ZEPATIER + RBV 16 tednov
English: The medicinal product interactions described are based on results from studies conducted with either ZEPATIER or elbasvir (EBR) and grazoprevir (GZR) as individual agents, or are predicted medicinal product interactions that may occur with elbasvir or grazoprevir.
Slovenian: Opisana medsebojna delovanja zdravil temeljijo na izsledkih študij zdravila ZEPATIER ali elbasvirja (EBR) ali grazoprevirja (GZR) samega, oziroma gre za predvidena medsebojna delovanja, ki se lahko pojavijo z elbasvirjem ali grazoprevirjem.
English: • joint pain or painful, swollen joints
Slovenian: • bolečine v sklepih ali boleči, otečeni sklepi
English: Higher rates of late ALT elevations occurred in females (2 % [11/652]), Asians (2 % [4/165]), and subjects aged ≥ 65 years (2 % [3/187]) (see sections 4.8 and 5.2).
Slovenian: Večji deleži zakasnelega zvišanja ALT so se pojavili pri ženskah (2 % [11/652]), Azijcih (2 % [4/165]) in preiskovancih, starih ≥ 65 let (2 % [3/187]) (glejte poglavji 4.8 in 5.2).
English: Based on in vitro data, clinically significant interactions with ZEPATIER as an inhibitor of other CYP enzymes, UGT1A1, esterases (CES1, CES2, and CatA), OAT1, OAT3, and OCT2 are not expected.
Slovenian: Na podlagi podatkov in vitro ni pričakovati klinično pomembnega medsebojnega delovanja zdravila ZEPATIER kot zaviralca drugih encimov CYP, UGT1A1, esteraz (CES1, CES2 in CatA), OAT1, OAT3 in OCT2.
English: ZEPATIER for 12 weeks
Slovenian: Zdravilo ZEPATIER 12 tednov
English: 12 weeks (N=79)
Slovenian: 12 tednov (n = 79)
English: Treatment-emergent substitutions observed in the viral populations of these subjects based on genotypes are shown in Table 6.
Slovenian: Med zdravljenjem nastale substitucije, opažene v virusnih populacijah pri teh preiskovancih glede na genotipe, so prikazane v preglednici 6.
English: Hepatic laboratory testing should be performed prior to therapy, at treatment week 8, and as clinically indicated.
Slovenian: Laboratorijske teste za oceno delovanja jeter je treba opraviti pred začetkom zdravljenja, v 8. tednu zdravljenja in še glede na klinične indikacije.
English: The pharmacokinetics of elbasvir/grazoprevir in paediatric patients less than 18 years of age have not been established (see section 4.2).
Slovenian: Farmakokinetika elbasvirja/grazoprevirja pri pediatričnih bolnikih, starih manj kot 18 let, ni bila določena (glejte poglavje 4.2).
English: Other includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
Slovenian: "Drugo" vključuje preiskovance, ki so z zdravljenjem prenehali zaradi neželenega učinka, so se izgubili spremljanju ali so se umaknili iz študije.
English: Tell your doctor or pharmacist if you have problems swallowing tablets.
Slovenian: Zdravnika ali farmacevta obvestite, če imate težave pri požiranju tablet.
English: HCV replicons with reduced susceptibility to elbasvir and grazoprevir have been selected in cell culture for genotypes 1a, 1b and 4.
Slovenian: Replikoni HCV z zmanjšano dovzetnostjo za elbasvir in grazoprevir so bili izbrani v celični kulturi za genotipe 1a, 1b in 4.
English: Available pharmacokinetic data in animals has shown excretion of elbasvir and grazoprevir in milk.
Slovenian: Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje elbasvirja in grazoprevirja v mleko.
English: Pharmacotherapeutic group: Antivirals for systemic use, Direct acting antivirals, Antivirals for treatment of HCV infections, ATC code: J05AP54.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zdravila z direktnim delovanjem na viruse, zdravila za zdravljenje infekcij z virusom hepatitisa C, oznaka ATC: J05AP54.
English: What you need to know before you take ZEPATIER
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo ZEPATIER
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ZEPATIER in one or more subsets of the paediatric populations in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom ZEPATIER za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: What ZEPATIER is used for ZEPATIER is used to treat long-term hepatitis C infection in adults aged 18 years and older.
Slovenian: Zdravilo ZEPATIER uporabljamo za zdravljenje dolgotrajne okužbe s hepatitisom C pri odraslih, starih 18 let ali več.
English: Do not take ZEPATIER if:
Slovenian: Ne jemljite zdravila ZEPATIER:
English: Psychiatric disorders: Common insomnia, anxiety, depression
Slovenian: Psihiatrične motnje: Pogosti nespečnost, anksioznost, depresija
English: Talk to your doctor or pharmacist before taking ZEPATIER if you have ever taken any medicines for hepatitis C or if you have any other medical condition.
Slovenian: Pred začetkom jemanja zdravila ZEPATIER se posvetujte z zdravnikom ali farmacevtom, če ste kdaj jemali katero koli zdravilo za hepatitis C, ali če imate kakršno koli drugo bolezen.
English: • Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discoloured faeces.
Slovenian: • Bolnikom je treba naročiti, naj se takoj posvetujejo z zdravnikom, če se pri njih pojavi utrujenost, splošna oslabelost, pomanjkanje apetita, navzea in bruhanje, zlatenica ali svetlo blato.
English: Table 5: Activities of elbasvir and grazoprevir in GT1a, GT1b and GT4 reference sequences and clinical isolates in replicon cells
Slovenian: Preglednica 5: Aktivnosti elbasvirja in grazoprevirja v GT1a, GT1b in GT4 referenčnih zaporedjih in kliničnih izolatih celičnih replikonov
English: HMG-CoA REDUCTASE INHIBITORS
Slovenian: ZAVIRALCI REDUKTAZE HMG-CoA
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Zepatier the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Slovenian: Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom Zepatier, 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: Patients should be instructed that if vomiting occurs within 4 hours of dosing, an additional tablet can be taken up to 8 hours before the next dose.
Slovenian: Bolnikom je treba naročiti, naj v primeru, da v 4 urah po zaužitju zdravila bruhajo, vzamejo dodatno tableto do 8 ur pred naslednjim odmerkom.
English: There are some medicines you must not take with ZEPATIER.
Slovenian: Nekaterih zdravil ne smete jemati skupaj z zdravilom ZEPATIER.
English: Elbasvir and grazoprevir are not expected to be removed by peritoneal dialysis.
Slovenian: Ni pričakovati, da se elbasvir in grazoprevir odstranita s peritonealno dializo.
English: Elbasvir has minimal intestinal P-gp inhibition in humans, and does not result in clinically relevant increases in concentrations of digoxin (a P-gp substrate), with an 11% increase in plasma AUC.
Slovenian: Elbasvir pri človeku minimalno zavira P-gp v črevesu in ne povzroči klinično pomembnega zvišanja koncentracije digoksina (ki je substrat P-gp); AUC v plazmi poveča za 11 %.
English: Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY and C-SURFER.
Slovenian: Vključuje preiskovance iz C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY in C-SURFER.
English: For patients receiving 16 weeks of therapy, additional hepatic laboratory testing should be performed at treatment week 12.
Slovenian: Če traja zdravljenje 16 tednov, je treba dodatno laboratorijsko preiskavo jetrnih testov opraviti v 12. tednu zdravljenja.
English: ZEPATIER for 16 weeks plus ribavirin
Slovenian: Zdravilo ZEPATIER 16 tednov plus ribavirin
English: Table 4: Selected treatment emergent laboratory abnormalities Laboratory Parameters
Slovenian: Preglednica 4: Izbrani, zaradi zdravljenja nastali, nenormalni izvidi laboratorijskih preiskav Laboratorijski parametri
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking ZEPATIER.
Slovenian: Če kaj od naštetega velja za vas (ali če niste prepričani), se pred jemanjem zdravila ZEPATIER posvetujte z zdravnikom ali farmacevtom.