FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section
Slovenian: Pri bolnikih (n=20), sodelujočih v kliničnih študijah, z zvišano ALT več kot 5 kratno ULN je bilo zdravljenje prekinjeno in v večini primerov so se koncentracije znižale na manj kot 2 kratno ULN v 2 do 4 mesecih.
English: Other medicines and RILUTEK Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Common side effects (may affect up to 1 in 10 people) of RILUTEK are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) zdravila RILUTEK so: omotica odrevenelost ali mravljinčavost ust bruhanje zaspanost pospešen srčni utrip driska glavobol bolečine v trebuhu bolečine
English: Do not take RILUTEK if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases), if you are pregnant or breast-feeding.
Slovenian: Ne jemljite zdravila RILUTEK - če ste alergični na riluzol ali katero koli sestavino tega zdravila(navedeno v poglavju 6), - če imate katero od bolezni jeter ali zvišanje krvnih koncentracij določenih jetrnih encimov
English: Manufacturer Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne France
Slovenian: Izdelovalec Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, 60205 Compiègne, Francija
English: Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne France
Slovenian: Sanofi Winthrop Industrie, 56, Route de Choisy au Bac, 60205 Compiègne, Francija.
English: You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast-feeding.
Slovenian: Nosečnost, dojenje in plodnost Zdravila RILUTEK NE SMETE jemati, če ste noseči ali mislite, da ste noseči ali če dojite.
English: RILUTEK is contraindicated in pregnancy (see sections 4.3 and 5.3).
Slovenian: Zdravilo RILUTEK je kontraindicirano med nosečnostjo (glejte poglavji 4.3 in 5.3).
English: The active substance in RILUTEK is riluzole which acts on the nervous system.
Slovenian: Zdravilna učinkovina v zdravilu RILUTEK je riluzol, ki deluje na živčevje.
English: Very common side effects (may affect more than 1 in 10 people) of RILUTEK are: tiredness feeling sick increased blood levels of some enzymes of the liver (transaminases).
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) zdravila RILUTEK so: - utrujenost - slabost - zvišanje koncentracij določenih jetrnih encimov (transaminaz) v krvi.
English: How to take RILUTEK
Slovenian: Kako jemati zdravilo RILUTEK
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sanofi Mature IP
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sanofi Mature IP
English: In vitro studies using human liver preparations demonstrated that cytochrome P450 1A2 is the principal isoenzyme involved in the metabolism of riluzole.
Slovenian: Študije preparatov človeških jeter in vitro so pokazale, da je P450 1A2 glavni izoencim, ki sodeluje v presnovi riluzola.
English: RILUTEK is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Slovenian: Zdravilo RILUTEK je kontraindicirano pri ženskah, ki dojijo (glejte poglavji 4.3 in 5.3).
English: RILUTEK 50 mg film-coated tablets Riluzole
Slovenian: RILUTEK 50 mg filmsko obložene tablete riluzol
English: Marketing Authorisation Holder Sanofi Mature IP
Slovenian: Imetnik dovoljenja za promet z zdravilom Sanofi Mature IP
English: RILUTEK is not recommended for use in paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti riluzola, pri katerikoli nevrodegenerativni bolezni otrok in mladostnikov, uporaba zdravila RILUTEK pri pediatrični populaciji ni priporočljiva.
English: Core:
Slovenian: Serija:
English: if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking RILUTEK to make sure that this does not occur.
Slovenian: - če se vam pojavi kateri od sledečih simptomov: porumenelost vaše kože ali beločnice vaših oči (zlatenica), srbenje po celem telesu, občutek slabosti, slabost, saj so to lahko znaki bolezni jeter (hepatitis).
English: Liver impairment
Slovenian: Ledvična okvara
English: Diarrhoea, abdominal pain, vomiting
Slovenian: Bolezni prebavil navzeja diareja, bolečine v trebuhu, bruhanje pankreatitis
English: RILUTEK is available in a pack of 56 tablets to be taken orally.
Slovenian: Zdravilo RILUTEK je na voljo v pakiranjih s 56 tabletami in ga jemljemo z zaužitjem.
English: Severe neutropenia (see section 4.4)
Slovenian: (glejte poglavje 4.4)
English: Warnings and precautions Talk to your doctor before taking RILUTEK: if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick if your kidneys are not working very well if you have any fever: it may be due to a low number of white blood cells which can cause an increased risk of infection If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.
Slovenian: (zlatenica), srbenje po celem telesu, občutek slabosti, slabost - če vam ledvice ne delujejo dobro - če imate vročino: pojavi se lahko zaradi znižanega števila belih krvnih celic, kar lahko poveča tveganje za okužbo
English: NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets
Slovenian: IME ZDRAVILA RILUTEK 50 mg filmsko obložene tablete
English: You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če po jemanju zdravila RILUTEK niste omotični ali vrtoglavi, lahko vozite ali upravljate s kakršnimikoli orodji ali stroji.
English: Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Slovenian: Jedro: brezvodni kalcijev hidrogenfosfat mikrokristalna celuloza brezvodni koloidni silicijev dioksid magnezijev stearat premreženi natrijev karmelozat
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 10. junij 1996
English: What RILUTEK contains
Slovenian: Kaj vsebuje zdravilo RILUTEK
English: What RILUTEK is
Slovenian: Kaj je zdravilo RILUTEK
English: Renal impairment Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Slovenian: Pri bolnikih z okvarjenim delovanjem ledvic študije s ponavljajočimi odmerki niso bile izvedene (glejte poglavje 4.2).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg of riluzole For the full list of excipients, see section 6.1.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 50 mg riluzola.
English: What RILUTEK is used for
Slovenian: Za kaj uporabljamo zdravilo RILUTEK
English: How to store RILUTEK
Slovenian: Shranjevanje zdravila RILUTEK
English: Titanium dioxide (E171)
Slovenian: Obloga: hipromeloza makrogol 6000 titanov dioksid (E 171)
English: Tel: +44 (0) 845 372 7101
Slovenian: United Kingdom sanofi-aventis Tel: +44 (0) 845 372 7101
English: Abnormal liver function tests
Slovenian: Bolezni jeter, žolčnika in žolčevodov nenormalni testi jetrnih funkcij hepatitis
English: Sanofi S.p.A. Tel: 800 536389
Slovenian: Tel: 800 536389
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/96/010/001
English: The expiry date refers to the last day of that month.
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Upor.
English: RE-EXAMINATION OF THE CHMP OPINION ADOPTED ON 23 APRIL 2009
Slovenian: PONOVNA PRESOJA MNENJA CHMP Z DNE 23. APRILA 2009
English: -The safety profile of ciclosporin is also critical.
Slovenian: - Varnostni profil ciklosporina je tudi kritičen.
English: In clinical routine practice therapeutic drug monitoring is done in order to control for and monitor safety.
Slovenian: V klinični rutinski praksi se izvaja terapevtsko spremljanje zdravil, da se nadzira in spremlja varnost zdravila.
English: Benefit/risk assessment
Slovenian: Ocena koristi in tveganj
English: 4) The fourth issue raised by CHMP was about the food effect on ciclosporin.
Slovenian: 4) Četrto vprašanje CHMP je bilo o učinku hrane na ciklosporin.
English: Summary of Grounds for Re-Examination
Slovenian: Povzetek podlage za ponovno presojo
English: In the MRP procedure (NL/H/1402/001-003/MR) potential serious risk for public health concern was raised on the following grounds: bioequivalence has not been sufficiently demonstrated.
Slovenian: V postopku z medsebojnim priznavanjem (NL/H/1402/001-003/MR) se je pojavil zadržek zaradi možnega resnega tveganja za javno zdravje zaradi sledečega vzroka: biološka enakovrednost ni bila zadostno dokazana.
English: ANNEX III CONDITION FOR THE LIFTING OF THE MARKETING AUTHORISATIONS SUSPENSION
Slovenian: DODATEK III POGOJI ZA PREKLIC ZADRŽANJA DOVOLJENJ ZA PROMET Z ZDRAVILOM
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: In addition, in the Transplant Patient Guide (University of Southern California-Cardiothoracic Surgery and Pancreas Transplant Program), it is recommended to take ciclosporin before meals, for better absorption by the stomach.
Slovenian: Poleg tega se v dokumentu Priročnik za bolnike o presaditvah (Transplant Patient Guide) (Univerza Južne Kalifornije - Program za kardiotorakalni kirurški poseg in presaditev trebušne slinavke (University of Southern California - Cardiothoracic Surgery and Pancreas Transplant Program)) priporoča, da se ciklosporin jemlje pred obroki zaradi boljše absorpcije v želodcu.
English: The Reference medicinal product authorised in Germany is: Sandimmun Optoral 25 mg Kapseln.
Slovenian: Referenčno zdravilo, odobreno v Nemčiji, je: Sandimmun Optoral 25 mg Kapseln.
English: Variable
Slovenian: Spremenljivka
English: 2) The second question raised by CHMP was whether the same acceptance range (either normal or narrowed) should be applied both for AUC and Cmax.
Slovenian: 2) Drugo vprašanje CHMP je bilo, ali je treba za vrednosti AUC in Cmax uporabiti enak razpon sprejemljivosti (bodisi običajni bodisi ožji).
English: Ciclosporin is indicated in transplantation (e.g. prevention or treatment of rejection of solid organ transplantation, bone marrow transplantation, graft-versus-host-disease) and auto-immune diseases (e.g nephrotic syndrome, rheumatoid arthritis, psoriasis, atopic dermatitis).
Slovenian: Ciklosporin je indiciran pri presaditvah (npr. preprečevanje ali zdravljenje zavrnitve presaditve trdnega organa, presaditve kostnega mozga, bolezni presadka proti gostitelju) ter avtoimunskih boleznih (npr. nefrotski sindrom, revmatski artritis, psoriaza, atopični dermatitis).
English: Strength Pharmaceutical Form
Slovenian: Farmacevtska oblika Pot uporabe zdravila
English: The number of adverse events may be associated with the huge variation in blood concentrations of the reference drug that will follow if it is taken regardless of food intake and the lack of instructions given regarding food intake.
Slovenian: Število neželenih dogodkov je lahko povezano z veliko variacijo koncentracij referenčnega zdravila v krvi, ki bo sledila vnosu zdravila ne glede na vnos hrane in odsotnost navodila o vnosu hrane.
English: This narrow range should apply to both AUC and Cmax as outside range values for any of both parameters can lead to efficacy and/or safety unwanted consequences.
Slovenian: Ožji razpon mora veljati za vrednosti AUC in Cmax, saj lahko vrednosti izven razponov obeh parametrov povzročijo neželene posledice v zvezi z učinkovitostjo ali varnostjo ali obojim.
English: The Efficacy Working Party PK expert group, consulted by the CHMP, understood that in clinical practice, ciclosporin is often recommended to be taken in a standardised way in relation to food.
Slovenian: Strokovna skupina za farmakokinetiko pri delovni skupini za učinkovitost, s katero se je posvetoval CHMP, je razumela, da se v klinični praksi pogosto priporoča standardizirano jemanje ciklosporina glede na hrano.
English: This may result in major swings in blood concentrations, since it has been shown that the intake of food has a very negative effect on absorption (up to about 30% reduction of Cmax and 15% reduction in AUC) of the reference product.
Slovenian: To lahko povzroči bistvena nihanja koncentracij v krvi, ker je bilo dokazano, da ima vnos hrane zelo negativen učinek na absorpcijo (do približno 30-odstotno zmanjšanje vrednosti Cmax in 15-odstotno zmanjšanje vrednosti AUC) referenčnega zdravila.
English: The CHMP addressed a list of questions to the Marketing Authorisation Holder and to the Efficacy Working Party PK expert group for consultation on the following points:
Slovenian: CHMP je posredoval seznam vprašanj imetniku dovoljenja za promet z zdravilom in strokovni skupini za farmakokinetiko pri delovni skupini za učinkovitost zaradi posvetovanja o naslednjih točkah:
English: There is emerging data indeed to suggest that appropriate therapeutic monitoring may radically reduce the incidence of acute rejection in de-novo recipients and ameliorate chronic rejection and secondary effects in maintenance transplant patients, as for ciclosporin, the patients inter and intra-variability is actually more problematic than the therapeutic index.
Slovenian: Objavljeni bodo podatki, ki kažejo, da lahko ustrezno terapevtsko spremljanje korenito zmanjša pojavnost akutne zavrnitve pri prejemnikih de novo ter izboljša kronično zavračanje in sekundarne učinke pri vzdrževanju bolnikov po presaditvi, saj je pri ciklosporinu variabilnost med bolniki in v okviru bolnika dejansko težavnejša od terapevtskega indeksa.
English: Differences in Cmax were considered less important, because a peak level is maintained for only a short period of time, whereas AUC represents the total exposure to the drug, but it was felt that the conventional range should be used.
Slovenian: Razlike v vrednosti Cmax so se štele za manj pomembne, ker najvišja koncentracija traja zelo kratek čas, vrednost AUC pa predstavlja celotno izpostavljenost zdravilu, vendar je predlagatelj menil, da je treba uporabiti običajni razpon.
English: The MAH stated that this issue needs to be addressed by the Regulatory Authorities and should be taken into consideration when evaluating IDL test product formulation, because this could play a definite role for safety issues, knowing that efficacy was preserved in any case as shown by the AUCs results.
Slovenian: Imetnik dovoljenja za promet z zdravilom je navedel, da morajo regulativni organi to zadevo obravnavati in upoštevati pri presoji preskušanega zdravila izdelovalca IDL, ker lahko odločilno vpliva na varnostna vprašanja ob upoštevanju, da je učinkovitost v vsakem primeru ohranjena, kar dokazujejo rezultati vrednosti AUC.
English: The issue here is clearly not a problem of interchangeability between Sandimmune and its optimized formulation of Neoral, but a lack of proof of bioequivalence, since this is a generic procedure.
Slovenian: Ne gre za težavo izmenljivosti zdravila Sandimmune in optimizirane formulacije zdravila Neoral, ampak nedokazane biološke enakovrednosti, ker gre za generični postopek.
English: 3) The third point raised by CHMP was whether the same set of requirements should be applied for assessing bioequivalence under high-fat fed conditions.
Slovenian: 3) Tretje vprašanje CHMP je bilo, ali je treba uporabiti enak nabor zahtev za vrednotenje biološke enakovrednosti pri preiskovancih s prehrano z veliko vsebnostjo maščob.
English: The MAH decided to appeal, and triggered a re-examination of the CHMP opinion on the following grounds:
Slovenian: Imetnik dovoljenja za promet z zdravilom se je odločil za pritožbo in sprožil ponovno presojo mnenja CHMP z naslednjimi razlogi:
English: The CHMP considered that the size of the particles is not a relevant argument for accepting wider bioequivalence range for ciclosporin.
Slovenian: CHMP je menil, da velikost delcev ni pomemben argument za sprejem širšega razpona za biološko enakovrednost ciklosporina.
English: Further, the MAH did not submit any data showing that Cmax values outside the bioequivalence criteria do not change the efficacy/safety performance of the product in comparison to the reference product.
Slovenian: Poleg tega imetnik dovoljenja za promet z zdravilom ni predložil nobenih podatkov, ki bi dokazovali, da vrednosti Cmax izven merila biološke enakovrednosti ne spremenijo učinkovitosti/varnosti zdravila v primerjavi z referenčnim zdravilom.
English: Ciclosporin is considered a ‘critical dose drug' with narrow therapeutic index.
Slovenian: Ciklosporin se šteje za „zdravilo z odločilnim odmerjanjem“ z ozkim terapevtskim indeksom.
English: A generic product should be possible to use interchangeably with an originator product without taking any extra measurements.
Slovenian: Generično zdravilo bi bilo treba uporabljati izmenično z originatorskim zdravilom brez posebnih preiskav.
English: However, in the absence of other data, it is not possible to confirm that under fed conditions the test product is bioequivalent and therefore will have the same efficacy and safety profile of the innovator.
Slovenian: Ker pa ni drugih podatkov, ni možno potrditi, da je pri neteščih preiskovancih preskusno zdravilo biološko enakovredno in da ima zaradi tega enak profil učinkovitosti/varnosti kot inovatorsko zdravilo.
English: The MAH answered that there doesn't seem to be a convincing reason why the range (80-125%) should be different for Cmax and AUC.
Slovenian: Imetnik dovoljenja za promet z zdravilom je odgovoril, da ni prepričljivega razloga, da se razpon (80125 %) pri vrednostih Cmax in AUC razlikuje.
English: Thus the CHMP retains its opinion and assessment report dated 23 April 2009 that the bioequivalence to the originator has not been shown and the benefit/risk ratio of Ciclosporin IDL is considered to be negative.
Slovenian: CHMP zato ni spremenil mnenja in poročila o oceni z dnem 23. aprila 2009, v katerem meni, da biološka enakovrednost originatorskemu zdravilu ni dokazana in da se razmerje med koristmi in tveganji za zdravilo Ciclosporin IDL šteje za negativnega.
English: The SPC for Sandimmun Optoral allows administration regardless of food, indicating that the known food effect for ciclosporin (approximately 26% reduction of Cmax and 15% reduction of AUC) is considered not clinically relevant.
Slovenian: Povzetek glavnih značilnosti zdravila Sandimmun Optoral dovoljuje dajanje ne glede na hrano, kar kaže, da se znani učinek hrane na ciklosporin (zmanjšanje vrednosti Cmax za približno 26 % in zmanjšanje vrednosti AUC za 15 %) šteje za klinično nepomembnega.
English: As ciclosporin is administered in high doses and for long periods of time in the clinical setting of transplantation, the CHMP refer to this indication for the justification of ciclosporin as being a NTI
Slovenian: Ker se ciklosporin daje v velikih odmerkih in za daljša časovna obdobja v kliničnem okolju presaditev, CHMP šteje to indikacijo za utemeljitev uvrstitve ciklosporina med zdravila NTI.
English: For generic applications no other data than bioequivalence is assessed and therefore approval should be based with confidence that such risk is reduced at maximum by narrowing the CI.
Slovenian: Pri generičnih vlogah se vrednoti le biološka enakovrednost, zato je treba z zoženjem intervala zaupanja zagotoviti, da odobritev temelji na zaupanju, da je takšno tveganje čim manjše.
English: For ciclosporin IDL, it was argued that because the differences observed between test and reference products under fed conditions were not due to the test product, but to the very profound effect of food on the blood levels of the reference product, no safety concern arose and the upper 90% confidence limit for comparison of Cmax (137%) was acceptable (see 4 below).
Slovenian: Za zdravilo Ciclosporin IDL so utemeljevali, da razlike, ki so bile opažene med preskusnim in referenčnim zdravilom pri neteščih preiskovancih, niso posledica preskusnega zdravila, ampak zaradi zelo izrazitega učinka hrane na ravni referenčnega zdravila v krvi, zato ni varnostnih zadržkov in je za primerjavo vrednosti Cmax sprejemljiva zgornja mejna vrednost 90-odstotnega intervala zaupanja (137 %) (glejte razdelek 4 v nadaljevanju).
English: The upper 90% interval confidence limit for Cmax, which should be considered for safety issues, is below the accepted limit (111%) for NTI products.
Slovenian: Zgornja meja intervala 90-odstotnega intervala zaupanja za vrednost Cmax, ki bi se morala upoštevati zaradi varnostnih razlogov, je pod sprejemljivo mejo (111 %) za zdravila NTI.
English: The CHMP, after the oral explanation, found that the data and the justification presented were not adequate to confirm the bioequivalence between the test and the originator.
Slovenian: CHMP je po ustni obrazložitvi presodil, da podatki in predstavljena utemeljitev niso zadostni za potrditev biološke enakovrednosti med preskusnim in originatorskim zdravilom.
English: The MAH stated that in the particular case of ciclosporin, and because of inter-subject variability, the monitoring of blood concentrations is the most important criterion to prevent from any public health issue.
Slovenian: Imetnik dovoljenja za promet z zdravilom je trdil, da je zaradi specifičnosti primera ciklosporina in variabilnosti med preiskovanci spremljanje koncentracij v krvi najpomembnejše merilo za preprečevanje vseh javnozdravstvenih težav.
English: Pharmaceutical properties of Sandimmune Optoral and Ciclosporin IDL micro emulsions
Slovenian: Farmacevtske lastnosti zdravil Sandimmune Optoral mikroemulzija in Ciclosporin IDL mikroemulzija
English: The classification of ciclosporin as an NTI drug could have been based on the adverse events associated with its use or on the concomitant use of other drugs.
Slovenian: Uvrstitev ciklosporina med zdravila NTI lahko temelji na neželenih dogodkih, ki so povezani z njegovo uporabo ali sočasno uporabo z drugimi zdravili.
English: Slightly smaller particles size of Ciclosporin IDL should be seen as an advantage for the absorption regarding food intake.
Slovenian: Nekoliko manjši delci zdravila Ciclosporin IDL bi se morali šteti kot prednost pri absorpciji v odvisnosti od vnosa hrane.
English: Taking this into account, the question was whether a reduced effect of food on generic ciclosporin pharmacokinetics could be considered acceptable for a ‘generic application', even in case that this results in a failure to comply with the predefined acceptance criteria (e.g. 80-125%) for concluding bioequivalence under fed conditions (in this case with a 90% CI for Cmax of 1.09-1.37).
Slovenian: Ob upoštevanju tega je bilo postavljeno vprašanje, ali je zmanjšan učinek hrane na farmakokinetiko generičnega ciklosporina lahko sprejemljiv za „generično vlogo“, čeprav v tem primeru to pomeni neskladnost z vnaprej opredeljenim kriterijem sprejemljivosti (npr. 80-125 %) biološke enakovrednosti pri neteščih preiskovancih (v tem primeru z 90-odstotnim intervalom zaupanja za vrednost Cmax, ki znaša 1,09