FrancophonIA/ELRC3.0 huggingface dataset:
English: http:// www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2009/09/WC500003946.
Slovenian: http:// http://www.ema.europa.eu/docs/en_GB/ document_library/Scientific_guideline/2009/09/ WC500003946.pdf.
English: Important considerations need to be borne in mind before an indication for a biosimilar can be approved based on extrapolated safety and efficacy data.
Slovenian: Preden se lahko indikacija za podobno biološko zdravilo odobri na podlagi ekstrapoliranih podatkov o varnosti in učinkovitosti, je potrebno obravnavati nekatere pomembne vidike.
English: 2016. http://ec.europa.eu/growth/toolsdatabases/newsroom/cf/itemdetail.cfm?item_ id=9066.
Slovenian: 2016. http://ec.europa.eu/growth/ content/commission-publishes-qa-biosimilarmedicines-patients-0_en.
English: Margins are established on the basis of knowledge of efficacy with the reference medicine, as well as on clinical judgement.
Slovenian: Za primarno končno točko učinkovitosti je potrebno izbrati ustrezne robne vrednosti intervalovekvivalence, ki se določijo na podlagi poznavanja učinkovitosti referenčnega zdravila ter klinične presoje.
English: By demonstrating high similarity with the reference medicine, the biosimilar can largely rely on the efficacy and safety experience gained with the reference medicine.
Slovenian: Primerjava zahtevanih podatkov za odobritev podobnega biološkega zdravila v primerjavi z referenčnim zdravilom z referenčnim zdravilom, se lahko pri podobnem biološkem zdravilu v veliki meri zanesemo na izkušnje z učinkovitostjo in varnostjo, pridobljene z referenčnim zdravilom.
English: eu/docs/en_GB/document_library/Scientific_ guideline/2014/10/WC500176768.pdf.
Slovenian: europa.eu/docs/en_GB/document_library/ Scientific_guideline/2014/10/WC500176768.
English: Biosimilarity
Slovenian: Bioekvivalenca
English: DNA
Slovenian: DNK
English: Implications of the availability of biosimilars
Slovenian: Pomen razpoložljivosti podobnih bioloških zdravil
English: Once the period of market protection of the reference medicine expires (usually 10 years), companies can market approved biosimilars.
Slovenian: Poslovni subjekti lahko tržijo odobrena podobna biološko zdravila po izteku obdobja tržne zaščite referenčnega zdravila (običajno po desetih letih).
English: eu/docs/en_GB/document_library/Scientific_ guideline/2009/09/WC500003935.pdf.
Slovenian: europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500003935.pdf.
English: Comparative clinical studies
Slovenian: Klinične študije
English: Clinical trials for biosimilars do not need to include all the pivotal studies conducted for the reference medicine to prove safety and efficacy in humans.
Slovenian: Za dokazovanje varnosti in učinkovitosti pri ljudeh ni treba, da klinična preskušanja za podobna biološka zdravila vključujejo vse ključne študije, izvedene za referenčno zdravilo.
English: 9, for example whenever a biological medicine with several approved indications undergoes major changes to its manufacturing process (e.g. new manufacturing site or development of new formulations).
Slovenian: Ekstrapolacija je dobro uveljavljeno znanstveno načelo, ki se uporablja že vrsto let9, na primer ob večjih spremembah postopka proizvodnje biološkega zdravila z več potrjenimi indikacijami (npr. nov proizvodni obrat ali razvoj novih farmacevtskih oblik).
English: europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500002805.pdf.
Slovenian: ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2009/09/WC500002805.pdf.
English: Safety of biosimilars
Slovenian: Varnost podobnih bioloških zdravil
English: Reference medicine Biosimilar medicine
Slovenian: Referenčno zdravilo Podobno biološko zdravilo
English: Safety monitoring of biosimilars follows the same requirements that apply to all biological medicines There is no specific requirement just for biosimilars.
Slovenian: Za spremljanje varnosti podobnih bioloških zdravil se uporabljajo enake zahteve kot za vsa biološka zdravila10.
English: Immunogenicity is always studied for biological medicines
Slovenian: Pri bioloških zdravilih se vedno prouči imunogenost6,7.
English: Adverse drug reaction
Slovenian: Neželeni učinek zdravila (angl. Adverse drug reaction)
English: Etanercept
Slovenian: Imunogenost
English: EU post-authorisation study register
Slovenian: EU PAS Register Register študij o varnosti zdravila po pridobitvi dovoljenja za promet v EU (angl. EU postauthorisation study register)
English: Natural variability is inherent to all biological medicines and strict controls are always in place during manufacturing to ensure that it does not affect the way the medicine works or its safety.
Slovenian: Med proizvodnjo zdravila se vedno izvaja strog nadzor za zagotovitev, da ta variabilnost ne vpliva na delovanje ali varnost zdravila.
English: Biosimilar approved in the EU (as at October
Slovenian: Podobna biološka zdravila, odobrena v EU
English: Batch 2
Slovenian: Serija 2
English: Glossary
Slovenian: Slovar
English: Batch 1
Slovenian: Serija 1
English: References
Slovenian: Vsebina
English: Batch 3
Slovenian: Serija 3
English: Biosimilar approved in the EU (as at October 2019)
Slovenian: © European Medicines Agency, 2019.
English: Death (all-cause)
Slovenian: Smrt (zaradi vseh vzrokov)
English: → Tell your doctor immediately.
Slovenian: → nemudoma obvestite svojega zdravnika.
English: Date of latest renewal: 14 January 2013
Slovenian: Datum zadnjega podaljšanja: 14. januar 2013
English: If you notice any of these signs:
Slovenian: Če opazite kateregakoli od teh znakov:
English: These tablets come in special packaging to prevent children removing them.
Slovenian: Tablete so v posebnem pakiranju, ki preprečuje, da bi jih vzeli otroci.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 April 2008
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 21. april 2008
English: No clinical data are available (see section 5.3 regarding data available in juvenile animals).
Slovenian: Klinični podatki niso na voljo (glejte poglavje 5.3 glede razpoložljivih podatkov pri mladih živalih).
English: If you have been told by your doctor that you have an intolerance to some sugars:
Slovenian: Če vam je vaš zdravnik povedal, da ne prenašate nekaterih sladkorjev:
English: Frequencies are defined as: 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: Pogostnost je opredeljena 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), zelo redki (< 1/10.000) ) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Patient reminder card should include the following key elements:
Slovenian: • opozorilno kartico za bolnika Opozorilna kartica za bolnika mora vsebovati naslednje ključne elemente:
English: In combination with tadalafil (another PAH medicine) In addition to the above:
Slovenian: V kombinaciji s tadalafilom (drugo zdravilo za PAH) Poleg zgoraj naštetega:
English: Volibris is not recommended for children and adolescents aged under 18 years as the safety and effectiveness is not known in this age group.
Slovenian: Zdravilo Volibris ni priporočljivo za otroke in mladostnike, mlajše od 18 let, ker njegova varnost in učinkovitost v tej starostni skupini nista znani.
English: % difference -33.8; 95% CI:
Slovenian: % razlike -33,8; 95 % IZ:
English: • ringing in the ears (tinnitus) only when taking the combination treatment.
Slovenian: • zvonjenje v ušesih (tinitus) le med kombiniranim zdravljenjem.
English: With longer observation in uncontrolled studies (mean observation of 79 weeks), the safety profile was similar to that observed in the short term studies.
Slovenian: Pri daljšem opazovanju v nenadzorovanih študijah (srednji čas opazovanja 79 tednov) je bil varnostni profil podoben varnostnemu profilu v kratkotrajnejših študijah.
English: • if you are allergic to ambrisentan, soya, or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na ambrisentan, sojo ali katerokoli sestavino tega zdravila (navedeno v poglavju
English: Make sure that you have also read the information in section 2 under ‘You will need regular blood tests' and ‘Signs that your liver may not be working properly'.
Slovenian: Preberite tudi informacije v poglavju 2 pod naslovom "Potrebne so redne krvne preiskave" in "Znaki nepravilnega delovanja jeter".
English: Patients should be aware of how they might be affected by ambrisentan before driving or using machines.
Slovenian: Bolniki morajo biti seznanjeni, , kako bi nanje lahko vplival ambrisentan, preden vozijo ali upravljajo s stroji.
English: Difference and Confidence Interval p value
Slovenian: Razlika in interval zaupanja
English: • Ambrisentan is a potent (Ki 0.016 nM) and highly selective ETA antagonist (approximately 4000-fold more selective for ETA as compared to ETB).
Slovenian: • Ambrisentan je močan (Ki 0,016 nM) in izredno selektiven antagonist ETA (približno 4.000-krat bolj selektiven za ETA kot za ETB).
English: → Don't take Volibris if you are pregnant or planning to become pregnant.
Slovenian: → Ne jemljite zdravila Volibris, če ste noseči ali nameravate zanositi.
English: The MAH shall ensure that in each Member State where Volibris is marketed, all patients who are expected to use Volibris are provided with the following educational material:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer se zdravilo Volibris trži, vsi bolniki, za katere se pričakuje, da bodo uporabljali zdravilo Volibris, prejeli naslednje izobraževalno gradivo:
English: Prior to use of Volibris in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred uporabo zdravila Volibris v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi ostalimi vidiki programa.
English: Your doctor may need to adjust your dose of Volibris if you start taking cyclosporine A (a medicine used after transplant or to treat psoriasis).
Slovenian: Zdravnik vam lahko prilagodi odmerek zdravila Volibris, če začnete jemati ciklosporin A (zdravilo, ki se uporablja po presaditvah organov ali za zdravljenje luskavice).
English: Push out the tablet: gently push one end of the tablet through the foil layer.
Slovenian: Potisnite tableto ven: previdno potisnite en konec tablete skozi plast folije.
English: The mean age of all patients was 54 years (SD 15; range 18-75 years of age).
Slovenian: Povprečna starost vseh bolnikov je bila 54 let (standardni odklon 15, razpon 18-75 let).
English: Volibris may also be used in combination with other medicines used to treat PAH.
Slovenian: Zdravilo Volibris se lahko uporablja tudi v kombinaciji z drugimi zdravili za zdravljenje PAH.
English: The combined mean exposure was approximately 145 ± 80 weeks, and the maximum exposure was approximately 295 weeks.
Slovenian: 80 tednov, najdaljša izpostavljenost pa je bila približno 295 tednov.
English: You may notice a rash or itching and swelling (usually of the face, lips, tongue or throat), which may cause difficulty in breathing or swallowing
Slovenian: Opazite lahko izpuščaj ali srbenje in otekanje (ponavadi obraza, ustnic, jezika ali žrela), ki lahko povzroči težave z dihanjem ali požiranjem.
English: Efficacy of combination therapy on the primary endpoint was consistent on the comparison to individual monotherapy and across the subgroups of age, ethnic origin, geographical region, aetiology (IPAH /hPAH and PAH-CTD).
Slovenian: Učinkovitost kombiniranega zdravljenja na primarni opazovani dogodek se je skladala s primerjavo z vsako posamezno monoterapijo in v podskupinah po starosti, etničnem izvoru, geografski regiji in etiologiji (IPAH/hPAH in PAH-CTD).
English: → Your doctor will decide whether Volibris is suitable for you.
Slovenian: → Vaš zdravnik bo presodil, ali je zdravilo Volibris primerno za vas.
English: Talk to your doctor, who will decide whether this medicine is suitable for you
Slovenian: Posvetujte se svojim zdravnikom, ki bo presodil, ali je to zdravilo primerno za vas;
English: • palpitations (fast or irregular heart beats)
Slovenian: • palpitacije (hitro ali neredno bitje srca),
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations) Harmire Road
Slovenian: Glaxo Operations UK Ltd (posluje kot GlaxoWellcome Operations) Harmire Road
English: • whether you have anaemia • whether your liver is working properly.
Slovenian: • če imate anemijo, • če je delovanje jeter pravilno.
English: Component as First Clinical Failure Event (Adjudicated)
Slovenian: Komponenta kot prvi dogodek kliničnega neuspeha (presojeno)
English: Sinusitis, rhinitis
Slovenian: Sinuzitis, rinitis
English: NT-proBNP (% reduction)
Slovenian: NT-proBNP (% znižanja) -67,2
English: • if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).
Slovenian: • če imate zabrazgotinjenje pljuč neznanega vzroka (idiopatsko pljučno fibrozo).
English: However, no specific drug-drug interactions studies have been conducted with these drugs.
Slovenian: Vendar pa s temi zdravili niso izvedli specifičnih študij medsebojnega delovanja zdravil.
English: Before you start taking Volibris, and at regular intervals while you're taking it, your doctor will take blood tests to check:
Slovenian: Pred začetkom zdravljenja z zdravilom Volibris in v rednih časovnih presledkih med zdravljenjem bo zdravnik opravljal krvne preiskave, s katerimi bo preverjal:
English: Pharmacotherapeutic group: Anti-hypertensives, other anti-hypertensives, ATC code: C02KX02
Slovenian: Farmakoterapevtska skupina: Antihipertenzivi, drugi antihipertenzivi, oznaka ATC: C02KX02 Mehanizem delovanja
English: In juvenile rats administered ambrisentan orally once daily during postnatal day 7 to 26, 36 or 62, a decrease in brain weight (−3% to -8%) with no morphologic or neurobehavioral changes occurred after breathing sounds, apnoea and hypoxia were observed.
Slovenian: Pri mladih podganah, ki so ambrisentan dobivale peroralno enkrat na dan od 7. do 26., 36. ali 62. dne po skotitvi, se je pojavilo zmanjšanje mase možganov (−3 % do -8 %), brez morfoloških ali nevrovedenjskih sprememb, po opaženih dihalnih zvokih, apneji in hipoksiji.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake "EXP".
English: The need for regular monitoring of liver function because Volibris may cause liver injury.
Slovenian: − da je potrebno redno nadzorovanje delovanja jeter, saj lahko zdravilo Volibris povzroči okvaro jeter.
English: If you take cyclosporine A, do not take more than one 5 mg tablet of Volibris, once a day.
Slovenian: Če jemljete ciklosporin A, ne smete vzeti več kot ene 5 mg tablete zdravila Volibris enkrat na dan.
English: In addition to the above, except abnormal blood test results for liver function:
Slovenian: Poleg zgoraj naštetega, razen nenormalnih izvidov preiskave krvi za delovanje jeter:
English: Hazard ratio (95% CI)
Slovenian: Razmerje ogroženosti (95 % IZ)
English: If you're taking rifampicin (an antibiotic used to treat serious infections) your doctor will monitor you when you first start taking Volibris.
Slovenian: Če jemljete rifampicin (antibiotik za zdravljenje resnih okužb), vas bo zdravnik nadziral, ko boste začeli jemati zdravilo Volibris.
English: Information from longer term non-placebo controlled studies (ARIES-E and AMBITION (combination with tadalafil)) is also included below.
Slovenian: Spodaj so vključene tudi informacije iz dolgoročnih študij, ki niso bile nadzorovane s placebom (ARIES-E in AMBITION (kombinacija s tadalafilom)).
English: were studied in healthy volunteers.
Slovenian: 20 zdravih prostovoljcih.
English: The safety of ambrisentan has been evaluated as monotherapy and/or in combination in clinical trials of more than 1200 patients with PAH (see section 5.1).
Slovenian: Varnost ambrisentana so v kliničnih preskušanjih vrednotili v monoterapiji in/ali v kombinaciji pri več kot 1.200 bolnikih s PAH (glejte poglavje 5.1).
English: Separate one tablet: tear along the cutting lines to separate one “pocket” from the strip.
Slovenian: Ločite eno tableto: odtrgajte vzdolž razdelilnih zarez, da boste en "žep" ločili od traku.
English: That Volibris is teratogenic in animals;
Slovenian: − da je zdravilo Volibris teratogeno pri živalih;
English: Odds ratio 1.56; 95% CI: 1.05,
Slovenian: 95 % IZ: 1,05,
English: The safety findings observed with long-term ambrisentan exposure in this study were generally consistent with those observed in the 12 week placebo-controlled studies.
Slovenian: Izsledki o varnosti, zabeleženi med dolgotrajno izpostavljenostjo ambrisentanu v tej študiji, so se na splošno ujemali s tistimi v 12tedenskih študijah, kontroliranih s placebom.
English: Patients enrolled into ARIES-1 and 2 were eligible to enter a long term open label extension study ARIES-E (n=383).
Slovenian: Bolniki, vključeni v študiji ARIES 1 in 2, so izpolnjevali pogoje za vključitev v dolgoročno odprto podaljšano študijo ARIES E (n = 383).
English: If you are allergic to soya, do not use this medicine (see section 2 ‘Don't take Volibris').
Slovenian: Ne uporabljajte tega zdravila, če ste alergični na sojo (glejte poglavje 2, "Ne jemljite zdravila Volibris").
English: What Volibris is and what it is used for
Slovenian: Kaj je zdravilo Volibris in za kaj ga uporabljamo
English: If you forget a dose of Volibris, just take the tablet as soon as you remember, then carry on as before.
Slovenian: Če ste pozabili vzeti odmerek zdravila Volibris, vzemite tableto takoj, ko se spomnite, nato pa nadaljujte z jemanjem zdravila ob običajnem času.
English: You can take Volibris with or without food.
Slovenian: Zdravilo Volibris lahko jemljete skupaj s hrano ali brez nje.
English: In addition, in patients, ambrisentan had no overall effect on the weekly warfarin-type anticoagulant dose, prothrombin time (PT) and international normalised ratio (INR).
Slovenian: Poleg tega pa ambrisentan pri bolnikih na splošno tudi ni vplival na tedenski odmerek antikoagulanta varfarinskega tipa, protrombinski čas (PTProthrombin Time) in mednarodno normalizirano razmerje (INR-International Normalized Ratio).
English: Nervous system disorders Headache (including sinus headache, migraine)
Slovenian: Bolezni živčevja Glavobol (vključno s sinusnim glavobolom, migreno)
English: What Volibris is and what it is used for What you need to know before you take Volibris How to take Volibris
Slovenian: Kaj je zdravilo Volibris in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Volibris Kako jemati zdravilo Volibris
English: % subjects achieving a satisfactory clinical response at week 24
Slovenian: % bolnikov, ki so dosegli zadovoljiv klinični odziv
English: • swelling in the hands, ankles or feet caused by fluid (peripheral oedema)
Slovenian: • otekle dlani, gležnje ali stopala zaradi kopičenja tekočine (periferni edemi),
English: Sudden hearing loss
Slovenian: Nenadna izguba sluha
English: The in vitro plasma protein binding of ambrisentan was, on average, 98.8% and independent of concentration over the range of 0.2 - 20 microgram/ml.
Slovenian: Vezava ambrisentana na plazemske proteine je bila in vitro v povprečju 98,8-odstotna in v razponu od 0,2 do 20 mikrogramov/ml neodvisna od koncentracije.
English: • if you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception).
Slovenian: • če ste noseči, nameravate zanositi ali bi lahko zanosili, ker ne uporabljate zanesljive metode kontracepcije; glejte poglavje ‘Nosečnost';
English: Idiopathic or heritable PAH was the most common aetiology in the study population (56%), followed by PAH due to connective tissue disorders (37%), PAH associated with drugs and toxins (3%), corrected simple congenital heart disease (2%), and HIV (2%).
Slovenian: Najpogostejši vzrok je bila v študijski populaciji idiopatska ali dedna PAH (56 %), sledili so PAH zaradi bolezni vezivnega tkiva (37 %), PAH, povezana z zdravili in toksini (3 %), korigirane enostavne prirojene srčne hibe (2 %) in
English: Uncommon3,8
Slovenian: Občasni3,8
English: → Contact your doctor before taking Volibris.
Slovenian: → posvetujte se s svojim zdravnikom, preden začnete jemati zdravilo Volibris.
English: In combination with tadalafil • sudden hearing loss.
Slovenian: V kombinaciji s tadalafilom • nenadna izguba sluha.
English: If you are a man taking Volibris, it is possible that this medicine may lower your sperm count.
Slovenian: Če ste moški in jemljete zdravilo Volibris, vam to zdravilo lahko zmanjša število semenčic.
English: Co. Durham DL12 8DT United Kingdom
Slovenian: Co. Durham DL12 8DT Velika Britanija
English: The binding affinity of 4-hydroxymethyl ambrisentan for the human endothelin receptor is 65-fold less than ambrisentan.
Slovenian: Vezavna afiniteta 4hidroksimetil ambrisentana za humane endotelinske receptorje je 65-krat manjša od vezavne afinitete ambrisentana.
English: Co. Durham DL12 8DT United Kingdom or
Slovenian: Co. Durham DL12 8DT Velika Britanija ali
English: → Don't take two doses at the same time to make up for a forgotten dose.
Slovenian: → Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: 1 See section ‘Description of selected adverse reactions'.
Slovenian: NP - ni poročano 1 Glejte poglavje "Opis izbranih neželenih učinkov'
English: Other side effects include Very common side effects:
Slovenian: Med drugimi neželenimi učinki so Zelo pogosti neželeni učinki:
English: If a patient is hypersensitive to soya, ambrisentan must not be used (see section 4.3).
Slovenian: Če je bolnik preobčutljiv na sojo, se ambrisentana ne sme uporabljati (glejte poglavje 4.3).
English: Conditions you and your doctor need to look out for:
Slovenian: Stanja, na katera morata biti pozorna vaš zdravnik in vi: Alergijske reakcije
English: Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
Slovenian: vključno z različno dolžino trajanja študij, predhodnim zdravstvenim stanjem in izhodiščnimi značilnostmi bolnika.
English: In the ARIES-E open label long term extension study, the 2 year risk of developing serum aminotransferase elevations >3xULN in patients treated with ambrisentan was 3.9%.
Slovenian: V dolgotrajni, odprti podaljšani študiji ARIES E je bilo 2-letno tveganje za zvišanje serumske aminotransferaze na > 3-kratno ZMN pri bolnikih, ki so prejemali ambrisentan, 3,9 %.
English: If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Volibris and regularly while you are taking this medicine.
Slovenian: Če ste ženska v rodni dobi, bo zdravnik opravil test za ugotavljanje nosečnosti pred začetkom zdravljenja z zdravilom Volibris in redno med jemanjem tega zdravila.
English: That pregnant women must not take Volibris;
Slovenian: − da nosečnice ne smejo jemati zdravila Volibris;
English: 22.75m; 95% CI: 12.00, 33.50 p<0.0001
Slovenian: 22,75 m; 95 % IZ: 12,00, 33,50
English: Volibris is to be taken orally to begin at a dose of 5 mg once daily and may be increased to 10 mg daily depending upon clinical response and tolerability.
Slovenian: Zdravilo Volibris bolnik jemlje peroralno v začetnem odmerku 5 mg enkrat na dan; odmerek je mogoče povečati na 10 mg na dan, odvisno od kliničnega odziva in prenašanja.