FrancophonIA/ELRC3.0 huggingface dataset:
English: During the studies in patients with infantile-onset Pompe disease, the most common side effects with Myozyme (seen in more than 1 patient in 10) were tachycardia (rapid heartbeat), flushing (redness), cough, tachypnoea (rapid breathing), vomiting, urticaria (itchy rash), rash, pyrexia (fever) and decreased oxygen saturation (low oxygen levels in the blood).
Slovenian: Med študijo pri bolnikih s Pompejevo boleznijo z zgodnjim nastopom so bili najpogostejši neželeni učinki zdravila Myozyme (opaženi pri več kot 1 bolniku od 10) tahikardija (pospešen srčni utrip), zardevanje, kašelj, tahipneja (pospešeno dihanje), bruhanje, urtikarija (srbeč izpuščaj), izpuščaji, pireksija (povišana telesna temperatura) in zmanjšana nasičenost s kisikom (nizke ravni kisika v krvi).
English: Patients who receive Myozyme may develop antibodies (proteins that are produced in response to Myozyme).
Slovenian: Bolniki, ki prejemajo zdravilo Myozyme, lahko razvijejo protitelesa (beljakovine, ki se tvorijo kot odziv na zdravilo).
English: Enzyme replacement therapy provides patients with the enzyme they are lacking; in this case, alpha-glucosidase.
Slovenian: Encimska nadomestna terapija zagotavlja bolnikom encim, ki jim ga primanjkuje, v tem primeru alfa-glukozidazo.
English: The progressive build-up of glycogen causes a wide range of symptoms, including an enlarged heart, breathing difficulties and muscle weakness.
Slovenian: Naraščajoče kopičenje glikogena povzroča številne simptome, med drugim povečano srce, dihalne težave in oslabelost mišic.
English: Myozyme has been studied in two main studies involving a total of 39 babies and children up to the age of three and a half years with infantile-onset Pompe disease.
Slovenian: Zdravilo Myozyme je bilo raziskano v dveh glavnih študijah, ki sta vključevali skupno 39 dojenčkov in otrok do starosti treh let in pol z zgodnjim nastopom Pompejeve bolezni.
English: In the study of late-onset disease, patients had many of the same side effects, but they were seen less often than in studies of infantileonset disease.
Slovenian: V študiji poznega nastopa bolezni se je pojavilo veliko istih neželenih učinkov, vendar so bili opaženi manj pogosto kot v študijah bolezni z zgodnjim nastopom.
English: Almost all of the side effects seen with Myozyme occurred during or just after the infusion and were mild or moderate.
Slovenian: Skoraj vsi neželeni učinki, opaženi pri zdravilu Myozyme, so se pojavili med infundiranjem ali tik po njem ter so bili blagi do zmerni.
English: The replacement enzyme helps to break down glycogen and stops it building up abnormally in the cells.
Slovenian: Nadomestni encim pomaga razgraditi glikogen in tako preprečiti njegovo nenormalno kopičenje v celicah.
English: The company that makes Myozyme is putting a plan in place to ensure that Myozyme is used safely, mainly by monitoring how patients who receive Myozyme develop antibodies, by setting up a register open to all patients with Pompe disease, and by ensuring that doctors know about the reactions that patients may have to the infusion.
Slovenian: Družba, ki izdeluje zdravilo Myozyme, pripravlja načrt za zagotavljanje varne uporabe zdravila Myozyme, ki v glavnem obsega spremljanje, kako se pri bolnikih, ki prejemajo zdravilo Myozyme, razvijejo protitelesa, vodenje evidence vseh bolnikov s Pompejevo boleznijo ter zagotavljanje, da so zdravniki seznanjeni z vsemi reakcijami na infundiranje.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Myozyme.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Myozyme, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Myozyme treatment should be supervised by a doctor who has experience in the management of patients with Pompe disease or other inherited diseases of the same type.
Slovenian: Zdravljenje z zdravilom Myozyme mora nadzorovati zdravnik, ki ima izkušnje z obravnavo bolnikov s Pompejevo boleznijo ali drugo dedno boleznijo istega tipa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Myozyme to Genzyme Europe B.V. on 29 March 2006.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Myozyme, veljavno po vsej Evropski uniji, odobrila družbi Genzyme Europe B.V.
English: The full EPAR for Myozyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Myozyme je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Myozyme must not be used in people who have had a life-threatening anaphylactic (severe allergic) reaction to alglucosidase alfa or any of the other ingredients, which could not be managed by giving the medicine at a slower infusion rate and reduced dose.
Slovenian: Zdravilo Myozyme se ne sme uporabljati pri osebah, ki imajo smrtno nevarno anafilaktično (hudo alergijsko) reakcijo na alglukozidazo alfa ali katero koli drugo sestavino zdravila, ki je ni mogoče obvladati s počasnejšim infundiranjem in zmanjšanim odmerkom.
English: Patients with Pompe disease do not have enough of an enzyme called alpha-glucosidase.
Slovenian: Bolniki s to boleznijo nimajo dovolj encima, imenovanega alfa-glukozidaza.
English: What is the risk associated with Myozyme?
Slovenian: Kakšna tveganja so povezana z zdravilom Myozyme?
English: If the enzyme is not present, glycogen builds up in certain tissues, particularly the muscles, including the heart and diaphragm (the main breathing muscle under the lungs).
Slovenian: Če encima primanjkuje, se začne glikogen kopičiti v določenih tkivih, zlasti v mišičnih tkivih, vključno s srcem in trebušno prepono (glavno dihalno mišico pod pljuči).
English: Myozyme has also been compared with placebo (a dummy treatment) in one main study involving 90 patients with late-onset disease.
Slovenian: Zdravilo Myozyme so primerjali tudi s placebom (zdravilom brez zdravilne učinkovine) v eni glavni študiji, v kateri je sodelovalo 90 bolnikov s poznim nastopom bolezni.
English: The CHMP decided that Myozyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Myozyme večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Other information about Myozyme
Slovenian: Druge informacije o zdravilu Myozyme:
English: For the full list of all side effects reported with Myozyme, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Myozyme, glejte navodilo za uporabo.
English: In late-onset disease, Myozyme was more effective than placebo at improving both the distance the patients could walk and their lung function over the course of the study.
Slovenian: Pri poznem nastopu bolezni je zdravilo Myozyme med potekom študije učinkoviteje od placeba pomagalo pri povečanju razdalje, ki so jo bolniki lahko prehodili, in izboljšanju delovanja pljuč.
English: The active substance in Myozyme, alglucosidase alfa, is a copy of human alpha-glucosidase, which is produced by a method known as ‘recombinant DNA technology': the enzyme is made by a cell that has received a gene (DNA) that makes it able to produce the enzyme.
Slovenian: Zdravilna učinkovina zdravila Myozyme, alglukozidaza alfa, je kopija človeškega encima, ki jo proizvajajo po metodi, znani kot „tehnologija rekombinantne DNK“.
English: Why has Myozyme been approved?
Slovenian: Zakaj je bilo zdravilo Myozyme odobreno?
English: It contains the active substance alglucosidase alfa.
Slovenian: Vsebuje zdravilno učinkovino alglukozidazo alfa.
English: Myozyme is used to treat patients who have Pompe disease, a rare inherited disorder.
Slovenian: Zdravilo Myozyme se uporablja za zdravljenje Pompejeve bolezni, ki je redka dedna bolezen.
English: Myozyme is a powder that is made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Myozyme je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: What is Myozyme used for?
Slovenian: Za kaj se zdravilo Myozyme uporablja?
English: How has Myozyme been studied?
Slovenian: Kako je bilo zdravilo Myozyme raziskano?
English: What is Myozyme?
Slovenian: Kaj je zdravilo Myozyme?
English: How is Myozyme used?
Slovenian: Kako se zdravilo Myozyme uporablja?
English: How does Myozyme work?
Slovenian: Kako zdravilo Myozyme deluje?
English: Section 4 [Existing text may vary between products]
Slovenian: Poglavje 4 [Obstoječe besedilo se lahko razlikuje med izdelki]
English: The PL should be updated accordingly.
Slovenian: Navodilo za uporabo je treba ustrezno posodobiti.
English: The latter ones may be attributed to paclitaxel regardless of the treatment regimen.
Slovenian: Slednje neželene učinke bi bilo mogoče pripisati paklitakselu ne glede na shemo zdravljenja.
English: In addition, palmar-plantar erythrodysesthesia syndrome associated with paclitaxel treatment has been reported in clinical trials and in the published literature.
Slovenian: Poleg tega so o sindromu palmarno-plantarne eritrodisestezije, povezanim z zdravljenjem s paklitakselom, že poročali v kliničnih preskušanjih in objavljeni literaturi.
English: Data from published literature and administrative claims databases confirmed the persistence of neuropathy with paclitaxel exposure beyond 12 months.
Slovenian: Podatki iz objavljene literature in iz podatkovnih zbirk upravnih zahtevkov so potrdili vztrajanje nevropatije še več kot 12 mesecev po izpostavljenosti paklitakselu.
English: Amendments to be included in the relevant sections of the Package Leaflet (new text underlined and in bold, deleted text strike through)
Slovenian: Spremembe, ki jih je treba vključiti v ustrezna poglavja navodila za uporabo(novo besedilo je podčrtano in označeno krepko, izbrisano besedilo je prečrtano)
English: Based on a cumulative review of data from all the MAHs, the causal role of paclitaxel for palmarplantar erythrodysesthesia syndrome is at least a reasonable possibility.
Slovenian: Na podlagi celovitega pregleda podatkov vseh imetnikov dovoljenj za promet z zdravili, ki vsebujejo paklitaksel, je vzročna povezanost med paklitakselom in sindromom palmarno-plantarne eritrodisestezije vsaj razumno možna.
English: Annex I Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: PRILOGA I ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: Annex II Amendments to the product information of the nationally authorised medicinal product(s)
Slovenian: Priloga II Spremembe informacij o zdravilu za zdravila, ki so pridobila dovoljenje(-a) za promet po nacionalnem postopku
English: The following adverse reaction should be added under the SOC Skin and subcutaneous tissue disorders with a frequency “not known” (cannot be estimated from available data): “Palmar-plantar erythrodysesthesia syndrome*” *As reported in the post marketing surveillance of paclitaxel.
Slovenian: Naslednje neželene učinke je treba dodati pod organski sistem »Bolezni kože in podkožja« z oznako pogostnosti »neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)«: »sindrom palmarno-plantarne eritrodisestezije*« *Kot so poročali v okviru nadzora po dajanju zdravil, ki vsebujejo paklitaksel na trg.
English: Neuropathy is a known ADR with the use of paclitaxel.
Slovenian: Nevropatija je znan neželeni učinek pri uporabi paklitaksela.
English: Based on the data provided, it is recommended to update the current information on neuropathy in the SmPC, by adding information concerning persistent neuropathy after paclitaxel discontinuation.
Slovenian: Na podlagi predloženih podatkov se priporoča posodobitev trenutnih informacij o nevropatiji v Povzetku glavnih značilnosti zdravila tako, da se doda podatke o vztrajajoči nevropatiji po prekinitvi zdravljenja s paklitakselom.
English: Review of the post-marketing data revealed that neuropathy can persist after discontinuation of paclitaxel treatment.
Slovenian: Pregled podatkov po pridobitvi dovoljenja za promet je razkril, da lahko nevropatija vztraja tudi po prekinitvi zdravljenja s paklitakselom.
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for paclitaxel the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing paclitaxel is unchanged subject to the proposed changes to the product information.
Slovenian: Na podlagi znanstvenih zaključkov za paklitaksel odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) paklitaksel, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: In addition, the introductory sentence to the table listing adverse reactions is to be amended to reflect that it includes adverse reactions from post marketing experience, as appropriate: Table X lists adverse reactions (…) observed in (a) clinical study(ies) and adverse reactions from post-marketing experience.
Slovenian: Poleg tega je treba spremeniti uvodno besedilo preglednice, ki prikazuje navedene neželene učinke, da odražajo neželene učinke iz obdobja po prihodu zdravila na trg, kot je ustrezno: V preglednici X so navedeni neželeni učinki (…) iz klinične(-ih) študij(-e) in neželeni učinki iz obdobja po prihodu zdravila na trg.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for paclitaxel, the scientific conclusions of the CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za paklitaksel je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: From the cases of palmarplantar erythrodysesthesia syndrome and symptoms received by the MAHs, there were several cases with a positive dechallenge and with a positive rechallenge.
Slovenian: Med primeri sindroma palmarno-plantarne eritrodisestezije in simptomov, ki so jih prejeli imetniki dovoljenja za promet z zdravili, ki vsebujejo paklitaksel, je bilo več takšnih primerov, pri katerih so učinki izzveneli po prenehanju uporabe zdravila (angl. positve dechallenge) in se ponovno pojavili po ponovnem začetku uporabe zdravila (angl. positive rechallenge).
English: Very common (may effect more than 1 in 10 people) - Numbness, tingling or weakness in arms and legs (all symptoms of peripheral neuropathy)* *Can persist beyond 6 months of paclitaxel discontinuation Frequency not known (cannot be estimated from the available data): - redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - odrevenelost, mravljinčenje ali šibkost rok in nog (vsi simptomi periferne nevropatije)* *Lahko traja še več kot 6 mesecev po prekinitvi zdravljenja s paklitakselom.
English: Further, it has been demonstrated that peripheral neuropathies can persist beyond 6 months of paclitaxel discontinuation.
Slovenian: V besedilo poglavja 4.8, ki opisuje bolezni živčevja, je treba vključiti naslednjo navedbo: Nadalje je bilo dokazano, da lahko periferne nevropatije vztrajajo tudi več kot 6 mesecev po prekinitvi zdravljenja s paklitakselom.
English: A frequency of ‘not known (cannot be estimated from available data)' is considered appropriate.
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov): - pordelost in otekanje dlani ali stopal, kar lahko povzroči luščenje kože
English: The following phrase should be included as a footnote of the ADR ‘neuropathy' in the table listing adverse reactions: *Can persist beyond 6 months of paclitaxel discontinuation The following sentence should be included in the text describing nervous system disorders under the section 4.8:
Slovenian: V preglednico, ki prikazuje navedene neželene učinke, je treba kot opombo vključiti naslednjo navedbo: *Lahko traja še več kot 6 mesecev po prekinitvi zdravljenja s paklitakselom.
English: Therefore, the SmPC of paclitaxel should be updated with the inclusion of palmar-plantar erythrodysesthesia syndrome as an ADR in section 4.8 under SOC Skin and subcutaneous tissue disorders.
Slovenian: Zato je treba Povzetek glavnih značilnosti zdravila za paklitaksel posodobiti in med neželene učinke v poglavje 4.8, pod organski sistem »Bolezni kože in podkožja«, dodati sindrom palmarno-plantarne eritrodisestezije z oznako pogostnosti »neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)«.
English: Amendments to be included in the relevant sections of the Summary of Product
Slovenian: Spremembe, ki jih je treba vključiti v ustrezna poglavja v povzetku glavnih značilnosti zdravila (novo besedilo podčrtano in krepko, zbrisano besedilo je prečrtano)
English: MA (EU) Number
Slovenian: Številka postopka EMA
English: It may harm them,
Slovenian: Število ogroženih:
English: More than 90% of patients achieved this.
Slovenian: To je doseglo več kot 90 % bolnikov.
English: It is best to take your tablet at the same time each day.
Slovenian: Najboljše je, da tableto jemljete vsak dan ob istem času.
English: There is no experience in humans.
Slovenian: Pri človeku ni izkušenj.
English: If you notice any of these signs:
Slovenian: Če opazite katerega koli od teh znakov:
English: Sometimes this requires a blood transfusion.
Slovenian: Včasih je zaradi tega potrebna transfuzija krvi.
English: → Tell your doctor immediately.
Slovenian: → Nemudoma obvestite svojega zdravnika.
English: No specific antidote is available.
Slovenian: Specifični antidot ni na voljo.
English: No patients received placebo alone.
Slovenian: Noben bolnik ni prejemal samo placeba.
English: Unsatisfactory long-term clinical response
Slovenian: Nezadovoljiv dolgoročni klinični odziv
English: NT-proBNP (% reduction)
Slovenian: NT-proBNP (% znižanja)
English: No additional safety concerns were identified in these patients.
Slovenian: Pri teh bolnikih dodatnih težav z varnostjo niso odkrili.
English: → Don't drive or use machines if you're feeling unwell.
Slovenian: → Ne upravljajte vozil ali strojev, če se ne počutite dobro.
English: No data are available (see section 5.3 regarding data available in juvenile animals).
Slovenian: Podatki niso na voljo (glejte poglavje 5.3 glede razpoložljivih podatkov pri mladih živalih).
English: • loss of appetite
Slovenian: • izgubo apetita,
English: NR - not reported
Slovenian: NP - ni poročano
English: % subjects achieving a satisfactory clinical response at week 24
Slovenian: % bolnikov, ki so dosegli zadovoljiv klinični odziv 24. teden
English: Patient reminder card should include the following messages
Slovenian: Opozorilna kartica za bolnika mora vsebovati naslednja sporočila:
English: Conditions you and your doctor need to look out for:
Slovenian: Stanja, na katera morata biti pozorna vaš zdravnik in vi:
English: Cyclosporine A
Slovenian: Ciklosporin A
English: In the case of pronounced hypotension, active cardiovascular support may be required.
Slovenian: V primeru izrazite hipotenzije bo morda treba uvesti aktivno kardiovaskularno podporo.
English: Routine pharmacovigilance data are also presented.
Slovenian: Predstavljeni so tudi redni farmakovigilančni podatki.
English: • whether you have anaemia
Slovenian: • če imate anemijo,
English: The clinical relevance of this finding to the paediatric population is not fully understood.
Slovenian: Klinični pomen te ugotovitve za pediatrično populacijo ni povsem razjasnjen.
English: Talk to your doctor about this.
Slovenian: O tem se posvetujte s svojim zdravnikom.
English: Very common Very common
Slovenian: zelo pogosti zelo pogosti
English: The combined mean exposure was approximately 145 ± 80 weeks, and the maximum exposure was approximately 295 weeks.
Slovenian: Kombinirana povprečna izpostavljenost je bila približno 145 ± 80 tednov, najdaljša izpostavljenost pa je bila približno 295 tednov.
English: The effect on male human fertility is not known but a deterioration of spermatogenesis cannot be excluded.
Slovenian: Vpliv na plodnost moških ni znan, vendar ni mogoče izključiti poslabšanja spermatogeneze.
English: The advice of a hepatologist is recommended.
Slovenian: Priporočljivo je pridobiti mnenje hepatologa.
English: You will need regular blood tests
Slovenian: Potrebne so redne krvne preiskave
English: • The need for monthly pregnancy tests
Slovenian: • da je treba mesečno opravljati teste nosečnosti,
English: It belongs to a group of medicines called other antihypertensives (used to treat high blood pressure).
Slovenian: Spada v skupino zdravil, imenovanih drugi antihipertenzivi (uporabljajo se za zdravljenje visokega krvnega tlaka).
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: A pre-specified combined analysis of the Phase 3 studies (ARIES-C) was conducted.
Slovenian: Izvedena je bila tudi vnaprej določena kombinirana analiza študij 3. faze (ARIES-C).
English: Secondary endpoints were tested:
Slovenian: Testirani so bili sekundarni opazovani dogodki:
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 stroje.
English: Ambrisentan (AMBITION and ARIES-E)
Slovenian: Ambrisentan (AMBITION in ARIES-E)
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: Pharmacotherapeutic group: Anti-hypertensives, other anti-hypertensives, ATC code: C02KX02
Slovenian: Farmakoterapevtska skupina: antihipertenzivi, drugi antihipertenzivi, oznaka ATC: C02KX02
English: In combination with tadalafil (another PAH medicine) in addition to the above:
Slovenian: V kombinacija s tadalafilom (drugo zdravilo za zdravljenje PAH) poleg zgoraj naštetega:
English: The safety and efficacy of ambrisentan in children and adolescents aged below 18 years has not been established.
Slovenian: Varnost in učinkovitost ambrisentana pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
English: P-value, Log-rank test
Slovenian: Vrednost p, log-rang test
English: Your doctor will decide whether Ambrisentan Mylan is suitable for you.
Slovenian: Vaš zdravnik bo presodil, ali je zdravilo Ambrisentan Mylan primerno za vas.
English: Signs that your liver may not be working properly include:
Slovenian: Znaki nepravilnega delovanja jeter lahko vključujejo:
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: Talk to your doctor, who will decide whether this medicine is suitable for you - if you have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis).
Slovenian: Posvetujte se svojim zdravnikom, ki bo presodil, ali je to zdravilo primerno za vas; - če imate zabrazgotinjenje pljuč neznanega vzroka (idiopatsko pljučno fibrozo).
English: United Kingdom or
Slovenian: Združeno kraljestvo ali