FrancophonIA/ELRC3.0 huggingface dataset:
English: The other two studies lasted longer: one compared Sycrest with olanzapine over nine weeks in patients who had come from the short-term studies; and the other was a 12-week ‘add on' study, in which 326 patients who were already being treated with another medicine (lithium or valproic acid) were also given either Sycrest or placebo.
Slovenian: Preostali dve študiji sta trajali dlje: v eni so zdravilo Sycrest devet tednov primerjali z olanzapinom pri bolnikih, ki so zaključili kratkotrajni študiji; druga študija pa je bila 12-tedenska študija dodajanja zdravila, v kateri so 326 bolnikom, ki so že jemali drugo zdravilo (litij ali valprojsko kislino), poleg tega dajali še bodisi zdravilo Sycrest ali placebo.
English: The CHMP, however, did not recommend that the medicine be authorised to treat schizophrenia because of the lack of effectiveness shown in this illness.
Slovenian: Ni pa priporočil odobritve tega zdravila pri zdravljenju shizofrenije zaradi pomanjkanja dokazov o njegovi učinkovitosti pri tej bolezni.
English: Sycrest was effective at treating manic episodes in patients with bipolar disorder.
Slovenian: Zdravilo Sycrest je bilo učinkovito pri zdravljenju maničnih epizod pri bolnikih z bipolarno motnjo.
English: In two of these studies, a total of 977 adult patients were given Sycrest, olanzapine (another antipsychotic medicine) or placebo (a dummy treatment) over three weeks.
Slovenian: V dveh študijah so 977 odraslim bolnikom tri tedne dajali zdravilo Sycrest, olanzapin (drug antipsihotik) ali placebo (zdravilo brez zdravilne učinkovine).
English: In the second long-term study, the reductions in Y-MRS score were 10.3 and 7.9 for Sycrest and placebo, respectively, after three weeks and 12.7 and 9.3 after 12 weeks.
Slovenian: V drugi dolgotrajni študiji so pri uporabi zdravila Sycrest in placeba po treh tednih zabeležili zmanjšanje za 10,3 oziroma 7,9 točke, po 12 tednih pa za 12,7 in 9,3 točke.
English: What is Sycrest?
Slovenian: Kaj je zdravilo Sycrest?
English: In the first shortterm study, the reductions in Y-MRS score after three weeks were 11.5 and 14.6 points for Sycrest and olanzapine, respectively, compared with 7.8 points for placebo.
Slovenian: V prvi kratkotrajni študiji so se rezultati na lestvici Y-MRS po treh tednih zmanjšali za 11,5 oziroma 14,6 točke pri uporabi zdravila Sycrest in olanzapina, medtem ko so se pri uporabi placeba zmanjšali le za 7,8 točke.
English: What is Sycrest used for?
Slovenian: Za kaj se zdravilo Sycrest uporablja?
English: Four main studies looked at the use of Sycrest for manic episodes in bipolar disorder.
Slovenian: Uporabo zdravila Sycrest za zdravljenje maničnih epizod pri bipolarni motnji so raziskali v štirih glavnih študijah.
English: The reductions for the second shortterm study were 10.8 and 12.6 points for Sycrest and olanzapine, respectively, and 5.5 for placebo.
Slovenian: V drugi kratkotrajni študiji so se rezultati zmanjšali za 10,8 oziroma 12,6 točke pri zdravilu Sycrest in olanzapinu, medtem ko so se pri uporabi placeba zmanjšali za 5,5 točke.
English: In the first long-term study, a reduction in Y-MRS score of 12.9 was seen in patients taking Sycrest compared with 16.2 in patients taking olanzapine.
Slovenian: V prvi dolgotrajni študiji so pri bolnikih, ki so jemali zdravilo Sycrest, zabeležili zmanjšanje za 12,9 točke na lestvici Y-MRS, pri bolnikih, ki so jemali zdravilo olanzapin, pa za 16,2 točke.
English: How has Sycrest been studied?
Slovenian: Kako je bilo zdravilo Sycrest raziskano?
English: How does Sycrest work?
Slovenian: Kako zdravilo Sycrest deluje?
English: How is Sycrest used?
Slovenian: Kako se zdravilo Sycrest uporablja?
English: 28 August 2015
Slovenian: 28. avgust 2015
English: - You do not take the medicine every day.
Slovenian: - Zdravila ne jemljete vsak dan.
English: This includes patients:
Slovenian: To vključuje bolnike:
English: Time (months)
Slovenian: čas (meseci)
English: You may need medical treatment.
Slovenian: Morda bo potrebna zdravniška pomoč.
English: 90429 Nuremberg Germany
Slovenian: 90429 Nuremberg Nemčija
English: Your doctor will monitor your condition to see if the treatment is working.
Slovenian: Zdravnik bo nadzoroval vaše stanje in preverjal, ali zdravilo deluje.
English: Contraception for women and men
Slovenian: Kontracepcija za ženske in moške
English: This leaflet was last revised in Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano Drugi viri informacij
English: Do not change the dose without talking to your doctor.
Slovenian: Ne spreminjajte odmerka, ne da bi se posvetovali z zdravnikom.
English: - After Week 3 you start a new cycle again as shown in Tables 1 and 2 below.
Slovenian: - Po koncu 3. tedna začnete nov ciklus, kot je prikazano v spodnjih preglednicah 1 in 2.
English: - The medicine can be taken with or without food.
Slovenian: - Zdravilo lahko jemljete skupaj s hrano ali brez nje.
English: The educational programme is aimed to address the risk of medication error.
Slovenian: Izobraževalni program je namenjen zmanjševanju možnosti za napake pri zdravljenju.
English: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 ljudi)
English: Response rates are summarised in Table 9.
Slovenian: Stopnje odzivov so navedene v preglednici 9.
English: The majority of patients had received prior transplant (63.6%).
Slovenian: Večini bolnikov so predhodno že opravili presaditev (63,6 %).
English: Tell your doctor about all the doses that you have missed during any 21-day cycle of treatment.
Slovenian: Zdravnika opozorite na vse odmerke, ki ste jih pozabili vzeti v 21-dnevnem ciklusu.
English: The capsules should be swallowed whole with water, with or without food (see section 5.2), and they should not be opened, crushed or chewed.
Slovenian: Kapsule je treba pogoltniti cele z nekaj vode, skupaj s hrano ali brez nje (glejte poglavje 5.2), ne sme pa se jih odpirati, drobiti ali žvečiti.
English: Some side effects could be serious
Slovenian: Nekateri neželeni učinki so lahko resni.
English: OS was not statistically significantly different between the two treatment groups.
Slovenian: OS se med obema študijskima skupinama ni statistično značilno razlikovalo.
English: If you are pregnant, think you might be pregnant or plan to become pregnant, ask your doctor for advice.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
English: Then continue taking the medicine as normal.
Slovenian: Nato nadaljujte z jemanjem zdravila po običajnem razporedu.
English: A total of 53.0% of patients were male.
Slovenian: 53,0 % vseh bolnikov je bilo moških.
English: Your doctor will discuss with you which is the best method for you to use.
Slovenian: Z zdravnikom se lahko pogovorite, katera metoda bi bila za vas najprimernejša.
English: The median number of prior therapies was 1.0.
Slovenian: Mediano število predhodnih vrst zdravljenja je bilo 1,0.
English: Elderly population
Slovenian: Populacija starejših
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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); very rare (<1/10,000); and not known (cannot be estimated from available data).
Slovenian: Pri tem ustrezna kategorija pogostnosti posameznega neželenega učinka temelji na naslednjem dogovoru (CIOMS III): 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); zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: 15.7% of patients were exposed to study treatment for ≥48 weeks.
Slovenian: 15,7 % bolnikov je bilo izpostavljenih študijskemu zdravilu najmanj 48 tednov.
English: - Swallow the capsules whole with a glass of water.
Slovenian: Jemanje zdravila - Kapsule pogoltnite cele s kozarcem vode.
English: Neutropenia was frequently reported on the basis of laboratory findings determined during the study (all grades: 75%).
Slovenian: O nevtropeniji na podlagi laboratorijskih vrednosti, pridobljenih v času študije, so pogosto poročali (vse stopnje skupaj: 75 %).
English: Electrocardiographic changes
Slovenian: Elektrokardiografske spremembe
English: - Do not throw away any medicines via wastewater.
Slovenian: - Zdravila ne smete odvreči v odpadne vode.
English: Farydak with food and drink
Slovenian: Zdravilo Farydak skupaj s hrano in pijačo
English: More than one third (35.8%) of the patients were relapsed and refractory to prior treatment.
Slovenian: Pri več kot tretjini bolnikov (35,8 %) je prišlo do recidiva in neodzivnosti na predhodno zdravljenje.
English: PVC/PCTFE/Alu blister containing 6 capsules.
Slovenian: Pretisni omot iz PVC/PCTFE /Alu, ki vsebuje 6 kapsul.
English: Patients over 65 years of age had a higher frequency of selected adverse events and of discontinuation of treatment because of adverse events.
Slovenian: Pri bolnikih, ki so bili stari več kot 65 let, je pogosteje prišlo do določenih neželenih dogodkov in do prekinitve zdravljenja zaradi neželenih dogodkov.
English: Panobinostat is moderately (approximately 90%) bound to human plasma proteins.
Slovenian: Panobinostat se zmerno (približno v 90 %) veže na beljakovine v človeški plazmi.
English: In the phase III clinical study 162 out of 387 patients were aged 65 years or over.
Slovenian: V klinični študiji faze III je bilo 162 od skupaj 387 bolnikov starih 65 let ali več.
English: Take the pack and this leaflet with you.
Slovenian: Škatlico z zdravilom in to navodilo vzemite s seboj.
English: It is recommended that patients with clinical benefit continue the treatment for eight additional cycles.
Slovenian: Za bolnike, ki jim zdravljenje klinično koristi, je priporočeno zdravljenje z nadaljnjimi osmimi ciklusi.
English: The median duration of exposure in the study was 5.0 months.
Slovenian: Mediano trajanje izpostavljenosti zdravilu v študiji je bilo 5,0 meseca.
English: The median time to response was 1.4 months and the median duration of response was 6.0 months.
Slovenian: Mediani čas do odziva je bil 1,4 meseca, mediano trajanje odziva pa 6,0 meseca.
English: Your heart rate will also be checked using a machine that measures the electrical activity of the heart (called an ECG).
Slovenian: Preverili bodo tudi vaš srčni utrip in sicer ga bodo posneli z napravo za merjenje električne aktivnosti srca (kar imenujemo EKG).
English: Patients should be treated initially for eight cycles.
Slovenian: Bolnik naj najprej prejme osem ciklusov.
English: Anticipated pharmacodynamic interactions
Slovenian: Predvidene farmakodinamske interakcije
English: The following pack sizes are available: blister packs containing 6, 12 or 24 capsules.
Slovenian: Na voljo so naslednje velikosti pakiranj: pretisni omoti, ki vsebujejo po 6, 12 ali 24 kapsul.
English: - Farydak is taken over 21 days (2 weeks on and 1 week off) - this is called a treatment cycle.
Slovenian: - Zdravilo Farydak je treba jemati po razporedu v obdobju 21 dni (2 tedna zdravljenja in 1 teden premora) - to imenujemo ciklus zdravljenja.
English: Treatment discontinuation due to infections was reported in 5% of patients.
Slovenian: O prekinitvi zdravljenja zaradi okužbe so poročali pri 5 % bolnikov.
English: Cycles 9-16 (3-week cycles)
Slovenian: ciklusi 9-16 (3-tedenski ciklusi)
English: The primary endpoint was progression free survival (PFS) as per modified European Bone Marrow Transplant Group (mEBMT) criteria and as assessed by the investigator.
Slovenian: Primarni cilj opazovanja je bilo preživetje brez napredovanja bolezni po modificiranih kriterijih Evropske skupine za presaditev kostnega mozga (angl. European Bone Marrow Transplant Group, kriteriji mEBMT) in oceni raziskovalca.
English: Medicinal products with laxative properties should be used with caution because of the potential for exacerbation of diarrhoea.
Slovenian: Pri uporabi zdravil z odvajalnimi lastnostmi je potrebna previdnost zaradi možnosti poslabšanja diareje.
English: These patients had a median of 3 prior therapies.
Slovenian: Ti bolniki so imeli mediano 3 predhodne vrste zdravljenja.
English: Its fraction in the erythrocyte is 0.60 in vitro, independent of the concentration.
Slovenian: In vitro znaša njegov delež v eritrocitih 0,60 in ni odvisen od koncentracije.
English: Since food did not alter overall bioavailability (AUC), panobinostat can be administered regardless of food in cancer patients.
Slovenian: Ker hrana ni vplivala na celotno biološko uporabnost (AUC) panobinostata, ga je pri bolnikih z rakom mogoče jemati s hrano ali brez nje.
English: Farydak is not to be used in children or adolescents under 18 years of age.
Slovenian: Otroci in mladostniki Zdravilo Farydak ni namenjeno uporabi pri otrocih ali mladostnikih, ki so stari manj kot 18 let.
English: Apparent panobinostat renal clearance (CLR/F) was found to range from 2.4 to 5.5 l/h.
Slovenian: Navidezni ledvični očistek panobinostata (CLR/F) je po podatkih znašal od 2,4 do 5,5 l/h.
English: The primary endpoint of the study was to assess overall response rate (ORR) after 8 cycles of therapy
Slovenian: Primarni cilj opazovanja v študiji je bila skupna stopnja odziva (overall response rate, ORR) po kriterijih mEBMT po 8 ciklusih zdravljenja.
English: - If it is less than 12 hours since you should have taken the medicine, take the missed dose as soon as you remember.
Slovenian: - Če je minilo manj kot 12 ur od takrat, ko bi morali vzeti zdravilo, vzemite odmerek takoj, ko se spomnite nanj.
English: - Do not take this medicine after the expiry date, which is stated on the carton and blister foil.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu.
English: Therefore, medicinal products that can influence CYP3A4 enzyme activity may alter the pharmacokinetics of panobinostat.
Slovenian: Zdravila, ki vplivajo na encimsko aktivnost CYP3A4, lahko zato spremenijo farmakokinetiko panobinostata.
English: Packs containing 6, 12 or 24 capsules.
Slovenian: Pakiranja vsebujejo po 6, 12 ali 24 kapsul.
English: During Farydak treatment, you should also tell your doctor or your pharmacist if you are prescribed another medicine that you have not already been taking.
Slovenian: V času zdravljenja z zdravilom Farydak morate zdravnika ali farmacevta obvestiti tudi v primeru, da vam dodatno predpišejo novo zdravilo, ki ga prej še niste jemali.
English: The median duration of exposure to study treatment was 4.6 months (range: 0.1-24.1 months).
Slovenian: Mediana trajanja izpostavljenosti študijskemu zdravilu je znašala 4,6 meseca (v razponu od 0,1 do 24,1 meseca).
English: If you use a hormonal contraceptive you must also use a barrier method of contraception (such as condom or diaphragm) in addition.
Slovenian: Če uporabljate hormonske kontraceptive, morate poleg teh uporabljati še katero od pregradnih metod kontracepcije (kot sta kondom ali diafragma).
English: - Do not store above 30°C.
Slovenian: - Shranjujte pri temperaturi do 30 °C.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX42
Slovenian: Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe, oznaka ATC: L01XX42
English: Treatment was administered for a maximum of 16 cycles (see Tables 1 and 2).
Slovenian: Zdravila so prejemali največ 16 ciklusov (glejte preglednici 1 in 2).
English: An increase in early resorptions was observed in female rats (doses ≥30 mg/kg).
Slovenian: Pri podganjih samicah so opažali povečan obseg zgodnje resorpcije zarodkov (pri odmerkih ≥30 mg/kg).
English: How much to take
Slovenian: Koliko zdravila je treba jemati
English: Studies in animals have shown reproductive and embryo-foetal toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja in embriofetalno toksičnost (glejte poglavje 5.3).
English: The list of associated symptoms is provided in section 4, Possible side effects.
Slovenian: Seznam simptomov, ki so povezani z navedenimi težavami, lahko najdete v poglavju 4, Možni neželeni učinki.
English: Your doctor will tell you exactly how many capsules of Farydak you need to take.
Slovenian: Zdravnik vam bo povedal, koliko kapsul zdravila Farydak morate vzeti.
English: Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval.
Slovenian: Po predkliničnih in kliničnih podatkih ima panobinostat potencial za podaljšanje intervala QT.
English: The median age was 63 years, range 28-84; 42.1% of patients were older than 65 years.
Slovenian: Mediana starost bolnikov je bila 63 let, v razponu od 28 do 84 let, 42,1 % bolnikov pa je bilo starejših od 65 let.
English: - Do not take Farydak in Week 3.
Slovenian: - V 3. tednu ciklusa ne jemljete zdravila Farydak.
English: Cycles 1-8 (3-week cycles)
Slovenian: ciklusi 1-8 (3-tedenski ciklusi)
English: The incidence of deaths not related to study indication was 8.8% in patients ≥65 years of age compared to 5.4% in patients <65 years of age.
Slovenian: Do smrti, ki ni bila povezana s študijsko indikacijo, je prišlo pri 8,8 % bolnikov, ki so bili stari najmanj 65 let, v primerjavi s 5,4 % pri bolnikih, ki so bili stari manj kot 65 let.
English: If you feel dizzy while taking this medicine, do not drive a vehicle or use any tools or machines.
Slovenian: Če ste zaradi jemanja zdravila omotični, ne vozite in ne upravljajte strojev.
English: Farydak should not be taken during pregnancy, unless the potential benefit to the mother is greater than the potential risk to the baby.
Slovenian: Zdravila Farydak se ne sme jemati v nosečnosti, razen če možne koristi za mater presegajo možna tveganja za otroka.
English: Therefore, physicians and patients should be aware of the increased risk of thrombocytopenia and the potential for haemorrhage, especially in patients with coagulation disorders or in those who are receiving chronic anti-coagulation therapy.
Slovenian: Zdravniki in bolniki se morajo zato zavedati povečanega tveganja za trombocitopenijo in možnosti krvavitve, zlasti pri bolnikih z motnjami strjevanja krvi oziroma pri tistih, ki kronično prejemajo antikoagulacijska zdravila.
English: Carcinogenicity studies have not been performed with panobinostat.
Slovenian: Študij karcinogenosti s panobinostatom niso izvajali.
English: 1 Hazard ratio obtained from stratified Cox model
Slovenian: 1 razmerje ogroženosti izhaja iz stratificiranega Coxovega modela
English: Farydak may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Farydak lahko v manjši meri vpliva na sposobnost upravljanja vozil in strojev.
English: Strong CYP3A4 inducers
Slovenian: Močni induktorji CYP3A4
English: The MAH shall ensure that in each Member State where Farydak is marketed, all patients/carers who are expected to use Farydak have access to/are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da v vsaki državi članici, kjer tržijo zdravilo Farydak, vsi bolniki oziroma njihovi negovalci, ki bodo predvidoma uporabljali zdravilo Farydak, prejmejo naslednji komplet izobraževalnega gradiva oziroma jim je ta na voljo:
English: Neutropenia may require temporary or permanent dose reduction.
Slovenian: Nevtropenija Zaradi nevtropenije je v nekaterih primerih potrebno začasno ali trajno znižanje odmerka.
English: Panobinostat represented 6 to 9% of the drug-related exposure in plasma.
Slovenian: Panobinostat predstavlja 6 do 9 % izpostavljenosti v plazmi po odmerjanju zdravila.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: Fatalities involving either pneumonia or sepsis were reported.
Slovenian: Poročali so tudi o smrtnih primerih v povezavi s pljučnico ali sepso.
English: Gastrointestinal toxicity is very common in patients treated with panobinostat.
Slovenian: Gastrointestinalna toksičnost je pri bolnikih, ki prejemajo panobinostat, zelo pogosta.
English: The median OS was 17.5 months.
Slovenian: Mediani čas celokupnega preživetja je bil 17,5 meseca.
English: Follow all your doctor's instructions carefully.
Slovenian: Opozorila in previdnostni ukrepi Skrbno se držite zdravnikovih navodil.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in v vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Overall survival (OS) was the key secondary endpoint.
Slovenian: Pomemben sekundarni cilj opazovanja je bilo celokupno preživetje (OS-overall survival).
English: Platelet counts should be monitored at least twice a week until ≥50 x 109/l.
Slovenian: Koncentracijo trombocitov je treba izmeriti najmanj dvakrat na teden, dokler ne doseže vrednosti ≥50 x 109/l.
English: In the event of QT prolongation during treatment:
Slovenian: Če pride do podaljšanja intervala QT med zdravljenjem:
English: Women of child-bearing potential/Contraception in males and females
Slovenian: Ženske v rodni dobi/Kontracepcija pri moških in ženskah
English: Gastrointestinal toxicity
Slovenian: Gastrointestinalna toksičnost
English: This could potentially lead to slightly decreased exposure to sensitive CYP3A4 substrates.
Slovenian: To bi namreč lahko nekoliko znižalo koncentracije občutljivih substratov CYP3A4.
English: The European Medicines Agency has waived the obligation to submit the results of studies within all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Farydak za vse podskupine pediatrične populacije z diseminiranim plazmocitomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: On days when you do not have to take Farydak, including the rest period in week 3, scratch the relevant empty cavities with your finger nail to help you keep track of your medication schedule.
Slovenian: Na dan, ko vam zdravila Farydak ni treba vzeti, kar pomeni tudi v času premora v tretjem tednu, z nohtom spraskajte polje nad praznim prostorom in s tem označite, da sledite razporedu odmerjanja.
English: No data is available that can be used to exclude the risk that panobinostat could be a weak inducer of the enzyme CYP3A4 in the gastrointestinal tract.
Slovenian: Na voljo ni podatkov, na podlagi katerih bi lahko izključili možnost, da je panobinostat lahko šibak induktor encima CYP3A4 v gastrointestinalnem traktu.
English: If results of liver function tests show abnormalities according to the NCI-CTEP classification, dose adjustments for patients with mild and moderate hepatic impairment are recommended and the patient should be followed until values return to normal or pre-treatment levels.
Slovenian: Če izvid testov jetrne funkcije kaže patološke vrednosti glede na klasifikacijo NCI-CTEP, je pri bolnikih z blago ali zmerno okvaro jeter priporočena prilagoditev odmerka, bolnike pa je treba spremljati, dokler se navedene vrednosti ne vrnejo na normalne ali na vrednosti pred začetkom zdravljenja.
English: Women using hormonal contraceptives should additionally use a barrier method of contraception.
Slovenian: Ženske, ki uporabljajo hormonske kontraceptive, morajo poleg teh uporabljati še katero od pregradnih metod kontracepcije.