FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of IDflu have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila IDflu upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
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
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The immunogenicity and safety of subsequent formulations of the vaccine have also been examined in
Slovenian: V študijah so proučevali tudi imunogenost in varnost nadaljnjih formulacij cepiva.
English: The CHMP decided that IDflu's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor CHMP je zaključil, da so koristi zdravila IDflu večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: IDflu is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease.
Slovenian: Zdravilo IDflu se uporablja za cepljenje odraslih, starejših od 60 let, proti gripi, zlasti tistih, pri katerih obstaja povečano tveganje za pojav zapletov pri bolezni.
English: People who have fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.
Slovenian: Osebe s povišano telesno temperaturo ali akutno (kratkotrajno) okužbo cepiva ne smejo prejeti, dokler ne
English: What is the risk associated with IDflu?
Slovenian: Kakšna tveganja so povezana z zdravilom IDflu?
English: The European Commission granted a marketing authorisation valid throughout the EU for IDflu on 24
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom IDflu, veljavno po vsej Evropski uniji, izdala
English: The ability of IDflu to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people.
Slovenian: Učinkovitost zdravila IDflu pri sprožanju nastanka protiteles (imunogenost) so najprej ocenili v petih glavnih študijah, v katerih je sodelovalo več kot 9 000 oseb.
English: The vaccine contains fragments of influenza (flu) viruses that have been inactivated (treated to prevent them causing infection).
Slovenian: Vsebuje delce virusov influence (gripe), ki so bili inaktivirani (obdelani tako, da ne povzročajo okužbe).
English: Three studies looked at people aged 60 years and over, who were vaccinated with the 15-microgram strength.
Slovenian: V treh študijah so proučevali osebe, starejše od 60 let, ki so bile cepljene s 15-mikrogramskim odmerkom.
English: Why has IDflu been approved?
Slovenian: Zakaj je bilo zdravilo IDflu odobreno?
English: In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the comparator vaccines.
Slovenian: Pri odraslih, starejših od 60 let, je 15-mikrogramski odmerek zagotovil enako dobro zaščito kot primerjalna cepiva.
English: The studies compared the ability of the vaccines to trigger the production of antibodies (immunogenicity) by comparing antibody levels before
Slovenian: V študijah so primerjali učinkovitost cepiv pri sprožanju tvorbe protiteles (imunogenost) tako, da so primerjali ravni protiteles pred
English: IDflu contains fragments from three different strains of flu virus.
Slovenian: Zdravilo IDflu vsebuje delce treh različnih sevov virusa gripe.
English: When a person is given the vaccine, the immune system recognises the virus fragments as ‘foreign' and makes antibodies against them.
Slovenian: Ko oseba prejme cepivo, imunski sistem prepozna delce virusa kot tujke in proti njim razvije protitelesa.
English: IDflu is given as one ‘intradermal' injection into the upper layer of the skin, using a special micro-injection system.
Slovenian: Cepivo IDflu se daje kot intradermalna injekcija v zgornjo plast kože ob uporabi posebnega mikroinjekcijskega sistema.
English: In one study in people aged 60 years and over, IDflu was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response).
Slovenian: V eni študiji pri ljudeh, starejših od 60 let, so cepivo IDflu primerjali s cepivom proti gripi, ki je vsebovalo adjuvans (spojino, ki se doda za povečanje imunskega odziva).
English: IDflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe.
Slovenian: Zdravilo IDflu je cepivo, ki je na voljo kot suspenzija za injiciranje v napolnjeni injekcijski brizgi.
English: Later seasonal formulations of IDflu have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main studies.
Slovenian: Poznejše sezonske formulacije zdravila IDflu so sprožile podobne odzive protiteles proti trem sevom gripe, vključenim v cepivo, kot so bili tisti, opaženi v glavnih študijah.
English: How does IDflu work?
Slovenian: Kako zdravilo IDflu deluje?
English: The vaccine can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja cepiva je le na recept.
English: For the full list of all side effects reported with IDflu, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila IDflu, glejte
English: In the five original studies, both IDflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
Slovenian: V petih prvotnih študijah sta zdravilo IDflu in primerjalno cepivo povzročila zadostne koncentracije protiteles, ki so potrebne za zaščito proti vsem trem sevom gripe.
English: Fragments of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in IDflu before the
Slovenian: V zdravilo IDflu je treba pred njegovo uporabo vključiti delce virusnih sevov, za katere se glede na priporočila SZO za severno poloblo in priporočila Evropske unije (EU) predvideva, da bodo povzročali gripo v prihodnji sezoni.
English: The antibodies will then help to protect against the disease caused by these strains of flu virus.
Slovenian: Ta mu bodo pomagala pri obrambi pred boleznijo, ki jo ti sevi virusa gripe povzročajo.
English: In all studies, IDflu was compared with another flu vaccine given by injection into a muscle.
Slovenian: V vseh študijah so zdravilo IDflu primerjali z drugim cepivom proti gripi, ki je bilo injicirano v mišico.
English: The full EPAR for IDflu 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 IDflu je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Za več informacij o zdravljenju z zdravilom IDflu preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains.
Slovenian: Ob ponovni izpostavitvi kateremu od teh virusnih sevov bo imunski sistem lahko hitreje tvoril protitelesa.
English: The use of the vaccine should be based on
Slovenian: Uporabljati se mora v skladu z uradnimi
English: The shoulder is the recommended site of injection.
Slovenian: Priporočeno mesto za cepljenje je predel ramen.
English: The risk for humans is thus unknown.
Slovenian: Tveganje za ljudi zato ni znano.
English: You may need urgent treatment.
Slovenian: Morda boste potrebovali nujno zdravljenje.
English: Drink the liquid straight away.
Slovenian: Tekočino takoj popijte.
English: % of patients improved a, c
Slovenian: % bolnikov z izboljšanjem a, c
English: Other patient characteristics/intrinsic factors
Slovenian: Druge značilnosti bolnikov/intrinzični dejavniki
English: Do not give this medicine to children or adolescents under the age of 18 years.
Slovenian: Zdravila ne dajte otrokom ali mladostnikom, mlajšim od 18 let.
English: • It is important to take this medicine without food
Slovenian: • Pomembno je, da vzamete to zdravilo brez hrane.
English: Then fill the glass again with water and drink it to make sure all medicine is taken.
Slovenian: Nato kozarec ponovno napolnite z vodo in tudi to popijte, da boste zaužili vse zdravilo.
English: No other liquids should be used.
Slovenian: Drugih tekočin ne sme uporabljati.
English: The following other side effects have also been reported:
Slovenian: Poročali so tudi o sledečih drugih neželenih učinkih:
English: Interrupt until Grade 0/1
Slovenian: prekiniti, dokler se ne zmanjša na stopnjo 0/1
English: Therefore, treatment of children or adolescents with this medicinal product is not recommended.
Slovenian: Zato zdravljenja otrok ali mladostnikov s tem zdravilom ne priporočajo.
English: • If you have already eaten, wait at least 3 hours before taking this medicine.
Slovenian: • če ste že jedli, počakajte vsaj 3 ure, preden boste vzeli zdravilo.
English: Your doctor may adjust (increase or decrease) your dose depending on how well you tolerate this medicine.
Slovenian: Zdravnik vam bo lahko prilagajal (povečeval ali zmanjševal) odmerek, kar bo odvisno od tega, kako dobro boste prenašali to zdravilo.
English: It is important to take this medicine every day, as long as your doctor prescribes it for you.
Slovenian: Pomembno je, da vzamete zdravilo vsak dan, dokler vam ga zdravnik predpisuje.
English: Data on Black racial groups was limited.
Slovenian: Podatkov o rasni skupini temnopoltih je bilo malo.
English: • Take this medicine at least 1 hour before eating, or
Slovenian: • Zdravilo vzemite najmanj eno uro pred jedjo ali,
English: Efficacy in EGFR-negative tumours has not been established.
Slovenian: Učinkovitost v EGFR-negativnih tumorjih ni bila ugotovljena.
English: Treatment with this medicine is not recommended if you have a severe liver disease.
Slovenian: Zdravljenje s tem zdravilom ni priporočljivo, če imate hudo jetrno bolezen.
English: Do not take a double dose (two tablets instead of one at the same time) to make up for a missed dose.
Slovenian: Ne vzemite dvojnega odmerka (dveh tablet naenkrat namesto ene), da bi nadomestili izpuščen odmerek.
English: • if you are female, have a low body weight of less than 50 kg or have kidney problems.
Slovenian: • če ste ženska, ste lažji od 50 kg ali imate težave z ledvicami.
English: Your doctor may want to monitor you more closely.
Slovenian: Zdravnik vas bo morda natančneje spremljal.
English: Your doctor will decide with you whether treatment should be continued or not.
Slovenian: Vaš zdravnik se bo skupaj z vami odločil, ali naj nadaljujete zdravljenje.
English: Grade 1 or Grade 2
Slovenian: Stopnja 1 ali stopnja 2
English: • Take this medicine once daily about the same time each day.
Slovenian: • Tableto vzemite vsak dan ob približno enakem času.
English: The tablets should be swallowed whole with water.
Slovenian: Tablete je treba pogoltniti cele z vodo.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALEC ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: When assessing the EGFR mutation status of a patient, it is important that a well-validated and robust methodology is chosen to avoid false negative or false positive determinations.
Slovenian: Pri ocenjevanju bolnikovega mutacijskega statusa EGFR je pomembno izbrati dobro validirano in robustno metodologijo, da bi se izognili lažno negativnim ali lažno pozitivnim ocenam.
English: Assessment of EGFR mutation status
Slovenian: Ocena mutacijskega statusa EGFR
English: If you do not take this medicine as prescribed by your doctor your cancer may grow again.
Slovenian: Če zdravila ne boste jemali, kot vam bo predpisal zdravnik, se lahko rak ponovno poveča.
English: These proteins are involved in the growth and spread of cancer cells, and can be affected by changes (mutations) in the genes that produce them.
Slovenian: Te beljakovine sodelujejo pri rasti in širjenju rakavih celic in lahko nanje vplivajo spremembe (mutacije) genov, ki jih izdelujejo.
English: Macrogol 400
Slovenian: • makrogol 400
English: Do not take GIOTRIF - if you are allergic to afatinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila GIOTRIF: - če ste alergični na afatinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Do not stop taking this medicine without first consulting your doctor.
Slovenian: Tega zdravila ne prenehajte jemati, ne da bi se prej posvetovali s svojim zdravnikom.
English: This makes it easier to remember to take this medicine.
Slovenian: To vam bo pomagalo, da se boste spomnili vzeti zdravilo.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including herbal medicines and medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi zeliščna zdravila in zdravila, ki jih lahko dobite brez recepta.
English: Your doctor may do some liver tests.
Slovenian: Zdravnik bo morda opravil nekatere jetrne preiskave.
English: The updated median OS for first- and second-line was 31.7 months and 23.6 months, respectively.
Slovenian: Posodobljena mediana vrednost skupnega preživetja za prvo in drugo linijo je bila 31,7 meseca oziroma 23,6 meseca.
English: The efficacy results are summarized in Table 9.
Slovenian: Rezultati učinkovitosti so povzeti v preglednici 9.
English: Therefore, an adverse effect of this medicinal product on human fertility cannot be excluded.
Slovenian: Škodljivega učinka zdravljenja s tem zdravilom na plodnost pri človeku zato ne moremo izključiti.
English: Diarrhoea usually occurred within the first 2 weeks of treatment.
Slovenian: Driska se je običajno pojavila v prvih dveh tednih zdravljenja.
English: Treatment with GIOTRIF should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Slovenian: Zdravljenje z zdravilom GIOTRIF mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: See also section 4 “Possible side effects”.
Slovenian: Glejte tudi poglavje 4 "Možni neželeni učinki".
English: If any of these apply to you, your doctor may monitor you more closely as the side effects may be more pronounced.
Slovenian: Če kar koli od naštetega velja za vas, vas bo zdravnik morda natančneje spremljal, ker so lahko neželeni učinki izrazitejši.
English: Overall, dose reduction (see section 4.2) led to a lower frequency of common adverse reactions.
Slovenian: Na splošno se je po znižanju odmerka (glejte poglavje 4.2) pogostost pogostih neželenih reakcij zmanjšala.
English: Patients with common EGFR mutations accounted for 89% of the study population.
Slovenian: Bolniki s pogostimi mutacijami EGFR so predstavljali 89 % raziskovane populacije.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 September 2013
Slovenian: Datum prve odobritve: 25. september 2013 Datum zadnjega podaljšanja:
English: Diarrhoea may result in dehydration with or without renal impairment, which in rare cases has resulted in fatal outcomes.
Slovenian: Driska lahko povzroči dehidracijo z ledvično okvaro ali brez nje in je v redkih primerih pripeljala do smrtnega izida.
English: Available non-clinical toxicology data have shown effects on reproductive organs at higher doses.
Slovenian: Razpoložljivi neklinični toksikološki podatki kažejo učinke na reproduktivne organe pri večjih odmerkih.
English: GIOTRIF has not been studied in children or adolescents.
Slovenian: Zdravila GIOTRIF pri otrocih ali mladostnikih niso raziskovali.
English: A risk to the breast-feeding child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ne moremo izključiti.
English: The following medicines may reduce the effectiveness of GIOTRIF:
Slovenian: Zdravila, ki lahko zmanjšajo učinkovitost zdravila GIOTRIF:
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Pri vsaki pogostnostni skupini so neželene reakcije prikazane v padajočem vrstnem redu glede na njihovo resnost.
English: Carcinogenicity Carcinogenicity studies have not been conducted with GIOTRIF.
Slovenian: Karcinogenost Raziskav o karcinogenosti z zdravilom GIOTRIF niso izvedli.
English: • Skin rash (very common).
Slovenian: • Kožni izpuščaj (zelo pogost).
English: • Bleeding from the nose
Slovenian: • krvavitev iz nosu
English: Proactive management of diarrhoea including adequate hydration combined with anti-diarrhoeal medicinal products especially within the first 6 weeks of the treatment is important and should start at first signs of diarrhoea.
Slovenian: Proaktivno zdravljenje driske, ki zajema ustrezno hidracijo v kombinaciji z antidiaroiki, je zlasti prvih 6 tednov zdravljenja pomembno in ga je treba uvesti ob njenih prvih znakih.
English: Treatment with this medicinal product should be interrupted pending investigation of these symptoms.
Slovenian: Zdravljenje s tem zdravilom je treba začasno prekiniti in počakati na izide preiskav nastalih simptomov.
English: Mutation in EGFR defines a distinct molecular subtype of lung cancer.
Slovenian: Mutacija EGFR opredeljuje razločljiv molekularni podtip pljučnega raka.
English: Afatinib is eliminated with an effective half-life of approximately 37 hours.
Slovenian: Afatinib se izloča s končno razpolovno dobo približno 37 ur.
English: Early intervention (such as emollients, antibiotics) of dermatologic reactions can facilitate continuous GIOTRIF treatment.
Slovenian: Zgodnja obravnava (uporaba emolientov, antibiotikov) dermatoloških reakcij lahko olajša neprekinjeno zdravljenje z zdravilom GIOTRIF.
English: Antidiarrhoeal medicinal products (e.g. loperamide) should be used and if necessary their dose should be escalated to the highest recommended approved dose.
Slovenian: Dajanje antidiaroikov (npr. loperamida) je nujno, njihov odmerek pa je treba po potrebi povečevati do največjega priporočenega odobrenega odmerka.
English: Interactions with BCRP
Slovenian: Medsebojno delovanje z BCRP
English: This medicine is used on its own to treat adult patients with a specific type of cancer of the lung (non-small cell lung cancer):
Slovenian: To zdravilo se uporablja samostojno za zdravljenje odraslih bolnikov s posebno obliko pljučnega raka (nedrobnoceličnega pljučnega raka):
English: GIOTRIF has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo GIOTRIF ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: In patients treated with afatinib for more than 6 months a terminal half-life of 344 h was estimated.
Slovenian: Pri bolnikih, ki se zdravijo z afatinibom več kot 6 mesecev, so ocenili, da je njegova končna razpolovna doba 344 ur.
English: Early treatment of skin rash is important.
Slovenian: Pomembno je zgodnje zdravljenje kožnega izpuščaja.
English: These could be symptoms of an inflammation of the lungs (interstitial lung disease) and can be lifethreatening.
Slovenian: To so lahko simptomi vnetja pljuč (intersticijske pljučne bolezni), ki je lahko življenjsko nevarno.
English: By blocking the activity of these proteins this medicine can inhibit growth and spread of cancer cells.
Slovenian: Z zaviranjem delovanja teh beljakovin lahko zdravilo zavre rast in širjenje rakavih celic.
English: Adverse changes were restricted to toxic dose levels.
Slovenian: Neželene spremembe so ugotovili le pri toksični ravni odmerkov.
English: Delay of time to deterioration (months)
Slovenian: Zapozneli čas do poslabšanja (meseci)
English: GIOTRIF may increase the blood levels of other medicines including but not limited to:
Slovenian: Zdravilo GIOTRIF lahko zviša raven drugih zdravil v krvi, med drugim (toda ne samo):
English: GIOTRIF is to be taken by mouth.
Slovenian: Zdravilo GIOTRIF je treba jemati skozi usta.
English: The individual effect sizes of these covariates were considered not clinically relevant.
Slovenian: Velikosti posamičnih učinkov teh sočasnih spremenljivk so ocenili za klinično nepomembne.
English: Therefore, this medicinal product is unlikely to interact with other medicines that modulate or are metabolised by CYP enzymes.
Slovenian: Zato ni verjetno, da bi to zdravilo součinkovalo z drugimi zdravili, ki modulirajo encime CYP ali jih ti encimi presnavljajo.
English: It works by blocking the activity of a group of proteins called the ErbB family (including EGFR [epidermal growth factor receptor or ErbB1], HER2 [ErbB2], ErbB3 and ErbB4).
Slovenian: Učinkuje tako, da zavira delovanje skupine beljakovin, ki se imenuje družina ErbB (zajema EGFR [receptor za epidermalni rastni dejavnik ali ErbB1], HER2 [ErbB2], ErbB3 in ErbB4).
English: The European Medicines Agency has waived the obligation to submit the results of trials with this medicinal product in all subsets of the paediatric population in NSCLC indications (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov preskušanj s tem zdravilom za vse podskupine pediatrične populacije pri indikacijah NSCLC (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Aberrant ErbB signalling triggered by receptor mutations, and/or amplification, and/or receptor ligand overexpression contributes to the malignant phenotype.
Slovenian: Aberantno signaliziranje ErbB, ki ga sprožijo mutacije receptorja, in/ali amplifikacija, in/ali prekomerna izraženost liganda, prispeva k malignemu fenotipu.
English: However, based on clinical data it is considered unlikely that GIOTRIF treatment will result in changes of the plasma concentrations of other P-gp substrates.
Slovenian: Na podlagi kliničnih podatkov pa menijo, da ni verjetno, da bi zdravljenje z zdravilom GIOTRIF vplivalo na koncentracijo drugih substratov P-gp v plazmi.
English: Stevens-Johnson syndrome Toxic epidermal necrolysis
Slovenian: Stevens-Johnsonov sindrom toksična epidermalna nekroliza
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: CR=complete response; PR=partial response
Slovenian: CR (complete response) = popoln odziv; PR (partial response) = delni odziv
English: There are no or limited amount of data from the use of this medicinal product in pregnant women.
Slovenian: Podatkov o uporabi tega zdravila pri nosečnicah ni oziroma so omejeni.
English: Do not open before use.
Slovenian: DRUGI PODATKI Ne odpirajte pred uporabo.
English: Treatment in this population is not recommended (see section 4.4).
Slovenian: Za to populacijo zdravila ne priporočajo (glejte poglavje 4.4).
English: Afatinib may increase the bioavailability of orally administered BCRP substrates (including but not limited to rosuvastatin and sulfasalazine).
Slovenian: Afatinib lahko poveča biološko uporabnost peroralnih substratov za BCRP (tudi, a ne samo, rosuvastatina in sulfasalazina).