FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBERS EU/1/00/162/003-005, EU/1/00/162/021
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/162/003-005, EU/1/00/162/021
English: MARKETING AUTHORISATION NUMBERS EU/1/00/162/015-17, EU/1/00/162/019
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/162/015-017, EU/1/00/162/019
English: At such times diabetic control may be lost.
Slovenian: V takšnih primerih lahko sladkorna bolezen postane neurejena;
English: NAME OF THE MEDICINAL PRODUCT Prandin 0.5 mg tablets
Slovenian: Prandin 0,5 mg tablete
English: In a study conducted in healthy volunteers, the concomitant administration of repaglinide (a single dose of 0.25 mg) and ciclosporin (repeated dose at 100 mg) increased repaglinide AUC and Cmax about 2.5-fold and 1.8-fold respectively.
Slovenian: V študiji pri zdravih prostovoljcih se je pri sočasni uporabi repaglinida (enkratni 0,25-mg odmerek) in ciklosporina (ponavljajoči se 100-mg odmerki) vrednost AUC repaglinida povečala za približno 2,5
English: • Visual disturbances
Slovenian: • motnje vida
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of repaglinide.
Slovenian: Ena tableta vsebuje 2 mg repaglinida.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg of repaglinide.
Slovenian: Ena tableta vsebuje 1 mg repaglinida.
English: Consequently metabolism, and by that clearance of repaglinide, may be altered by substances which influence these cytochrome P-450 enzymes via inhibition or induction.
Slovenian: V primeru uporabe učinkovin, ki vplivajo na ta encima citokroma P-450, bodisi z inhibicijo bodisi indukcijo, se presnova in s tem tudi očistek repaglinida lahko spremeni.
English: Repaglinide lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β-cells in the pancreatic islets.
Slovenian: Koncentracijo glukoze v krvi hitro zmanjša tako, da stimulira sproščanje insulina iz trebušne slinavke.
English: • Feeling sick (nausea).
Slovenian: • siljenje na bruhanje (navzea)
English: Name and address of the manufacturer responsible for batch release
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Novo Nordisk A/S
English: Repaglinide tablets are white, round and convex and engraved with Novo Nordisk logo (Apis bull).
Slovenian: Tablete repaglinida so bele, okrogle, izbočene in imajo vrezan logo družbe Novo Nordisk (bik Apis).
English: After a 5 day treatment of repaglinide (2 mg x 3/day) in patients with a severe impaired renal function (creatinine clearance: 20-39 ml/min.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic (očistek kreatinina: 20-39 ml/min) so rezultati po 5dnevnem zdravljenju z repaglinidom (2 mg 3-krat na dan) pokazali pomembno 2-kratno zvečanje izpostavljenosti (AUC) in razpolovnega časa (t1/2) v primerjavi z bolniki z normalnim delovanjem ledvic.
English: Hypoglycaemic coma and hypoglycaemic unconsciousness
Slovenian: Presnovne in prehranske motnje hipoglikemija pogosti hipoglikemična koma in hipoglikemična nezavest neznana
English: You should not take Prandin if you are breast-feeding.
Slovenian: Če dojite, zdravila Prandin ne smete jemati.
English: Be aware that the desired effect is not achieved if you stop taking Prandin.
Slovenian: Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.
English: NAME OF THE MEDICINAL PRODUCT Prandin 2 mg tablets
Slovenian: Prandin 2 mg tablete
English: Batch
Slovenian: Apis).
English: Repaglinide tablets are peach-coloured, round and convex and engraved with Novo Nordisk logo (Apis bull).
Slovenian: Tablete repaglinida so breskove barve, okrogle, izbočene in imajo vrezan logo družbe Novo Nordisk (bik Apis).
English: Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch
Slovenian: brezvodni kalcijev hidrogenfosfat koruzni škrob polakrilin kalij povidon (polividon)
English: In an interaction study in healthy volunteers, coadministration of 250 mg clarithromycin, a potent mechanism-based inhibitor of CYP3A4, slightly increased the repaglinide (AUC) by 1.4-fold and Cmax by 1.7-fold and increased the mean incremental AUC of serum insulin by 1.5-fold and the maximum concentration by 1.6-fold.
Slovenian: V študiji medsebojnega delovanja z drugimi zdravili, izvedeni pri zdravih prostovoljcih, se je pri sočasni uporabi klaritromicina v odmerku 250 mg, ki močno zavira encimski mehanizem CYP3A4, vrednost AUC repaglinida zvečala za 1,4-krat, vrednost Cmax pa za 1,7-krat.
English: What you need to know before you take Prandin
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Prandin Ne jemljite zdravila Prandin, če:
English: Repaglinide tablets are yellow, round and convex and engraved with Novo Nordisk logo (Apis bull).
Slovenian: Tablete repaglinida so rumene, okrogle, izbočene in imajo vrezan logo družbe Novo Nordisk (bik
English: Always take this medicine exactly as your doctor has told you.
Slovenian: Kako jemati zdravilo Prandin Pri jemanju tega zdravila natančno upoštevajte navodila svojega zdravnika.
English: NAME OF THE MEDICINAL PRODUCT Prandin 1 mg tablets
Slovenian: Prandin 1 mg tablete
English: Iron oxide, yellow (E172)
Slovenian: poloksamer, rumeni železov oksid (E172) v 1-mg tabletah in rdeči železov oksid (E172) v 2-mg tabletah.
English: - The active substance is repaglinide.
Slovenian: Repaglinid se skoraj v celoti presnovi.
English: • If you take too little Prandin
Slovenian: To se lahko zgodi: • če ste vzeli premajhen odmerek zdravila Prandin,
English: • ACE-inhibitors (used to treat heart conditions)
Slovenian: • zaviralce angiotenzinske konvertaze (zaviralci ACE, uporabljamo jih za zdravljenje bolezni srca),
English: Eight percent of one dose of repaglinide is excreted through the kidneys and total plasma clearance of the product is decreased in patients with renal impairment.
Slovenian: Pri bolnikih z okvaro ledvic je celoten plazemski očistek zdravila manjši.
English: A number of medicinal products are known to influence repaglinide metabolism.
Slovenian: Kaj vsebuje zdravilo Prandin - Zdravilna učinkovina je repaglinid.
English: Concomitant use
Slovenian: za peroralno uporabo
English: GROUNDS FOR NEGATIVE OPINION
Slovenian: RAZLOGI ZA NEGATIVNO MNENJE
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR NEGATIVE OPINION
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN RAZLOGI ZA NEGATIVNO MNENJE
English: 08013-Barcelona Spain
Slovenian: 08013-Barcelona Španija
English: For parametric analysis, the 90% confidence interval was calculated.
Slovenian: Za parametrično analizo so izračunali 90 % interval zaupanja.
English: In order to consider the parent compound as inactive, a significantly lower level of activity would have been required.
Slovenian: Da bi matično spojino uvrstili med neaktivne, bi bila potrebna pomembno nižja raven aktivnosti.
English: Histamine is a major mediator of the allergic reaction.
Slovenian: Histamin je pomemben posrednik v alergijski reakciji.
English: A post hoc justification for widening the acceptance range as was done for study SZ190/08 can therefore not be accepted.
Slovenian: Post hoc utemeljitev za razširitev razpona sprejemljivosti, kot je bila narejena pri študiji SZ190/08, zato ne more biti sprejeta.
English: This situation should have been foreseen and included in the study protocol and the CHMP therefore considers this to constitute a major objection.
Slovenian: Ta situacija bi morala biti predvidena in vključena v protokol študije, zato je CHMP mnenja, da predstavlja to pomemben ugovor.
English: 80 subjects were enrolled in the study and randomly assigned to a treatment.
Slovenian: V študijo je bilo vključenih 80 oseb in ti so bili naključno razporejeni v zdravljenje.
English: The Applicant requested an oral explanation in front of the committee in order to discuss the outcome of the CHMP assessment.
Slovenian: Predlagatelj je zaprosil za ustna pojasnila pred odborom, da bi se posvetovali o izidu ocene CHMP.
English: This increase justifies either an additional increase of subjects included in the study or a widening of the acceptance criteria.
Slovenian: To povečanje utemeljuje dodatno povečano število oseb, vključenih v študijo, ali razširitev kriterijev sprejemljivosti.
English: ANNEX III CONDITIONS FOR THE LIFTING OF THE MARKETING AUTHORISATION SUSPENSIONS
Slovenian: DODATEK III POGOJI ZA PREKLIC UMIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Verovskova 57 SI-1000 Ljubljana Slovenia
Slovenian: Verovškova 57 SI-1000 Ljubljana Slovenija
English: No clinically significant abnormalities were observed and the results confirmed the absence of significant changes in the subjects' state of health.
Slovenian: Klinično pomembnih nepravilnosti niso opazili, rezultati pa so potrdili odsotnost pomembnih sprememb v zdravstvenem stanju oseb.
English: The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holder(s):
Slovenian: Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, zagotovijo, da imetnik(-i) dovoljenja za promet z zdravilom izpolnjujejo sledeče pogoje:
English: A total of 30 post-dose adverse events were reported, with 6 adverse events probably related to the study treatment, 11 possibly related, 2 remotely related, and 11 unrelated.
Slovenian: Poročali so o skupno 30 neželenih učinkih, opaženih po zaužitju odmerka, od česar je bilo verjetno 6 neželenih učinkov povezanih z obdelavo študije, 11 morda povezanih, 2 šibko povezana in 11 nepovezanih.
English: The Applicant assumption that the parent compound is inactive was not accepted, as the absolute activity should be taken into account, rather than the ratio of activity compared to the metabolite.
Slovenian: Predlagateljeva domneva, da matična spojina ni aktivna, ni bila sprejeta, saj je treba upoštevati absolutno aktivnost in ne delež aktivnosti v primerjavi z metabolitom.
English: It was concluded that any arguments for the widening of the acceptance range must be discussed prospectively, and reflected in the protocol.
Slovenian: Zaključili so, da je treba o vseh vprašanjih glede širjenja razpona sprejemljivosti razpravljati vnaprej, in to se mora odražati tudi v protokolu.
English: The majority of adverse event were considered mild and the most commonly reported was headache (8.8% of subjects).
Slovenian: Večina neželenih učinkov je bila označena kot blagih, najpogosteje opažen pa je bil glavobol (pri 8,8 % oseb).
English: The statistic analysis was described adequately, and the methods for statistical assessment of this bioequivalence study were acceptable.
Slovenian: Statistična analiza je bila zadostno opisana, metode za statistično oceno te bioekvivalenčne študije pa so bile sprejemljive.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LORATADINE SANDOZ 10 AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA LORATADINE SANDOZ 10 IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: According to the guideline, a wider interval may be acceptable, but only if prospectively defined and justified, addressing in particular any safety or efficacy concerns for patients switched between formulations.
Slovenian: Skladno s smernicami je širši interval lahko sprejemljiv, vendar le, če je vnaprej opredeljen in utemeljen ter obravnava zlasti kakršnekoli zadržke glede varnosti ali učinkovitosti za bolnike, ki bi jim zamenjali formulacijo.
English: The Applicant emphasised that bioequivalence was shown for the metabolite, which is responsible for the main effect.
Slovenian: Predlagatelj je poudaril, da je bioekvivalenca dokazana za metabolit, ki je odgovoren za glavni učinek.
English: The guidelines state that “In principle, evaluation of bioequivalence should be based upon measured concentrations of the parent compound.
Slovenian: Smernice navajajo, da mora „načeloma ocena bioekvivalence temeljiti na izmerjenih koncentracijah matične spojine.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE, PREDLAGATELJEV / IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH
English: The data available shows that the parent compound is measurable, and therefore must be measured, in order to assess bioequivalence.
Slovenian: Razpoložljivi podatki kažejo, da je matična spojina merljiva in zato mora biti izmerjena, da se oceni bioekvivalenca.
English: Because major objections on bioequivalence remained unresolved, an Article 29(4) referral was triggered and the procedure was referred to the CHMP.
Slovenian: Ker so pomembni pomisleki o bioekvivalenci ostali nerazrešeni, je bil sprožen napotitveni postopek v skladu s členom 29(4) in zadeva je bila napotena na CHMP.
English: The Applicant was requested to provide the CHMP with the parent compound data from the submitted bioequivalence study or to provide satisfactory justifications for the absence of these data.
Slovenian: Predlagatelj je bil pozvan, naj odboru CHMP iz predložene študije bioekvivalence predloži podatke o matičnih spojinah ali pa naj pridobi zadovoljive utemeljitve za pomanjkanje teh podatkov.
English: The validation process was described in detail and the study and the analyses were made in accordance with GLP principles as well as international regulatory recommendations and guidelines.
Slovenian: Validacijski postopek je podrobno opisan v študiji, analize pa so bile narejene v skladu z načeli dobre laboratorijske prakse ter z mednarodnimi regulativnimi priporočili in smernicami.
English: In addition, the widening of the Confidence Intervals should be agreed prospectively in the study design.
Slovenian: Poleg tega mora biti razširitev intervala zaupanja sprejeta vnaprej že pri oblikovanju načrta študije.
English: The CHMP also considered that the choice of pharmacokinetic variables was adequate for this study and that the pharmacokinetic calculation was presented correctly.
Slovenian: CHMP je bil prav tako mnenja, da je bila izbira farmakokinetičnih spremenljivk zadostna za to študijo in da je bil farmakokinetični izračun pravilno prikazan.
English: The metabolite can be used as a surrogate only if the Applicant presents convincing arguments demonstrating that it is not possible to reliably measure the parent compound after a single administration, which is not the case for loratadine.
Slovenian: Metabolit lahko uporabimo kot nadomestek le, če predlagatelj predloži prepričljive dokaze, da zanesljivo merjenje matične spojine po enkratnem odmerku ni možno, kar pa ne velja za loratadin.
English: The following pharmacokinetic parameters were determined: AUC0-t, Cmax (primary) and AUC residual area, tmax, Ke;, t1/2 (secondary).
Slovenian: Določili so sledeče farmakokinetične parametre: AUC0-t, Cmax (primarni) in AUC območja preostanka, tmax, Ke;, t1/2 (sekundarni).
English: Regarding the basic statistical parameter analysis of AUC∞, AUCt and Cmax, both AUCs and Cmax values were subjected to analysis of variance (ANOVA), following the logarithmic transformation.
Slovenian: Glede osnovnih statističnih parametrov pri analizi AUC∞, AUCt in Cmax, so bile vrednosti obeh AUC in Cmax podvržene analizi variance (ANOVA), ki je sledila logaritemski transformaciji.
English: Treatment with H1 - antagonists for the sought indication requires sufficient therapeutic drug levels for a period superior to 24 hours in order to provide relief from symptoms and the Applicant therefore argued that the therapeutic effect is best represented by the AUC of the unchanged loratadine and the metabolite rather than the peak concentration of parent compound alone.
Slovenian: Zdravljenje te indikacije z zaviralci H1 zahteva zadostne terapevtske ravni zdravila v obdobju, daljšem od 24 ur, da se zagotovi olajšanje simptomov, predlagatelj pa se je glede tega zagovarjal, da terapevtski učinek najbolje predstavlja AUC nespremenjenega loratadina in metabolita, in ne le najvišja koncentracija matične spojine same.
English: Regarding the results, the Applicant provided the pharmacokinetic parameters for loratadine and for descarboethoxyloratadine as well as all the individual plasma concentrations, pharmacokinetic variables and individual graphs.
Slovenian: Glede rezultatov je predlagatelj predložil farmakokinetične parametre za loratadin in za deskarboetoksiloratadin, pa tudi vse posamezne koncentracije v plazmi, farmakokinetične spremenljivke in posamezne grafe.
English: The CHMP noted the presented data and stated that according to the current guideline (Questions & Answers on the Bioavailability and Bioequivalence Guideline CHMP/EWP/40326/06), bioequivalence should preferably be based on data for the parent drug, loratadine, as confirmed in the most recent draft guideline on bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1).
Slovenian: CHMP je upošteval predložene podatke in izjavil, da naj, v skladu s trenutnimi smernicami (Vprašanja in odgovori na smernico o biološki razpoložljivosti in bioekvivalenci CHMP/EWP/40326/06), bioekvivalenca temelji na podatkih o matičnem zdravilu loratadin, kot je bilo potrjeno v najnovejšem osnutku smernice o bioekvivalenci (CPMP/EWP/QWP/1401/98 Rev. 1).
English: The Applicant considered that due to the large intra-subject variability of loratadine, the use of a wider CI (0,75 - 1,33) was justified, and that differences in Cmax do not have a major clinical effect on the use of this product in humans.
Slovenian: Predlagatelj je bil mnenja, da je zaradi velike variabilnosti loratadina v osebah uporaba širšega intervala zaupanja (0,75-1,33) utemeljena in da razlike v Cmax nimajo velikega kliničnega učinka na uporabo tega zdravila pri ljudeh.
English: The Applicant, taking into account the lack of serious safety or efficacy concerns, therefore concluded that Loratadine Sandoz 10 can be considered to be efficacious and safe.
Slovenian: Predlagatelj je, ob upoštevanju odsotnosti resnih zadržkov glede varnosti ali učinkovitosti, zaključil, da zdravilo Loratadine Sandoz 10 lahko velja kot učinkovito in varno.
English: In addition, Sandoz pharmacovigilance database indicates that there are no unaddressed safety or efficacy concerns for Loratadine Sandoz 10.
Slovenian: Poleg tega podatkovna baza farmakovigilance družbe Sandoz nakazuje, da ni nikakršnih nerešenih zadržkov glede varnosti ali učinkovitosti za zdravilo Loratadine Sandoz 10.
English: The data showed that for loratadine, the 90% confidence interval for Cmax is outside the predefined acceptance range of 80-125% (although the 90% confidence intervals for AUC0-t, AUC0-∞ were respected).
Slovenian: Podatki so pokazali, da je za loratadin 90 % interval zaupanja za Cmax izven vnaprej določenega razpona sprejemljivosti 80-125 % (čeprav so bili upoštevani 90 % intervali zaupanja za AUC0-t in AUC0-∞).
English: Additionally, the results for AUC0-t, AUC0-∞ and Cmax of descarboethoxyloratadine demonstrated bioequivalence.
Slovenian: Poleg tega so rezultati AUC0-t, AUC0-∞ in Cmax za deskarboetoksiloratadin dokazali bioekvivalenco.
English: Loratadine is a potent, long acting antihistaminic which has a high selectivity for peripheral histamine H1-receptors and low affinity for H1-receptors in the central nervous system (CNS) in vitro or in vivo.
Slovenian: Loratadin je močan, dolgo delujoči antihistaminik, ki je visoko selektiven za periferne histaminske receptorje H1 in ima nizko afiniteto za receptorje H1 v osrednjem živčnem sistemu in vitro ali in vivo.
English: The CHMP also noted the statement on GLP compliance in bio-analysis and considered that the analytical methods are acceptable and validated appropriately and seem adequate to accurately determine the concentration of loratadine and descarboethoxyloratadine in plasma.
Slovenian: CHMP je prav tako upošteval izjavo o skladnosti dobre laboratorijske prakse v bioanalizi in je bil mnenja, da so analitične metode sprejemljive in primerno validirane ter se zdijo zadostne za natančno določanje koncentracije loratadina in deskarboetoksiloratadina v plazmi.
English: - retrospective widening of the confidence interval is not accepted according to the current guidelines,
Slovenian: - v skladu s trenutnimi smernicami retrospektivno širjenje intervala zaupanja ni sprejemljivo,
English: The Applicant submitted an application for a repeat use procedure of Loratadine Sandoz 10 and associated names, 10 mg tablets on the basis of the marketing authorisation granted by The Netherlands on 12 July 2001.
Slovenian: Predlagatelj je predložil vlogo za postopek ponovne uporabe zdravila Loratadine Sandoz 10 in z njim povezanih imen, 10 mg tablete, na podlagi dovoljenja za promet z zdravilom, ki ga je odobrila Nizozemska 12. julija 2001.
English: The arguments used by the Applicant that the increase of about 5% in the intra-individual variability of Cmax in the second study (CV of 46.4%) justifies the post-hoc widening of the acceptance criteria cannot be accepted.
Slovenian: Predlagateljeve trditve, da povečana intraindividualna variabilnost Cmax za približno 5 % v drugi študiji (s koeficientom variacije 46,4 %) utemeljuje post hoc širjenje kriterijev sprejemljivosti, ne morejo biti sprejete.
English: The Applicant should submit the results of a correctly planned study that demonstrates the bioequivalence between Loratadine Sandoz 10 and the reference product in accordance with the current guidelines.
Slovenian: Predlagatelj mora predložiti rezultate pravilno načrtovane študije, ki dokazuje bioekvivalenco med zdravilom Loratadine Sandoz 10 in referenčnim zdravilom, v skladu s trenutnimi smernicami.
English: The CHMP confirmed that the Guideline and the Q&A document (which were valid and available on the EMEA website at the time when the protocol for the bioequivalence study was finalized) state that a retrospective widening of the acceptance criteria for Cmax results is not allowed.
Slovenian: CHMP je potrdil, da smernica in dokument z vprašanji in odgovori (ki so bili v času, ko je bil protokol za bioekvivalenčno študijo končan, veljavni in na voljo na spletni strani EMEA) navajajo, da retrospektivno širjenje kriterijev sprejemljivosti za rezultate Cmax ni dovoljeno.
English: Therefore, in view of the results obtained from the original study, demonstrating an intra-individual CV of 41.2% for Cmax, a widening of the confidence interval should have been predefined in the study protocol of the second study (justifying any safety or efficacy concerns for patients switched between formulations).
Slovenian: Zato bi moralo biti glede na rezultate, dobljene iz izvorne študije, ki dokazujejo intraindividualni koeficient variacije za Cmax 41,2 %, širjenje intervala zaupanja v protokolu druge študije vnaprej določeno (z utemeljitvijo morebitnih zadržkov glede varnosti ali učinkovitosti za bolnike, ki bi jim zamenjali formulacijo).
English: The reason for this is that Cmax of a parent compound is usually more sensitive to detect differences between formulations in absorption rate than Cmax of a metabolite”.
Slovenian: Razlog za to je, da je, za razliko od Cmax metabolita, Cmax matične spojine navadno bolj občutljiv za zaznavo razlik v hitrosti absorpcije med posameznimi formulacijami“.
English: Detailed explanations of the statistical calculations and the improved bio-analytical methods used were provided and in addition, the Applicant explained that the pharmacokinetics of loratadine increased its intra-individual variability.
Slovenian: Predlagatelj je predložil podrobno razlago statističnih izračunov in uporabljenih izboljšanih bioanalitičnih metod, poleg tega pa je razložil, da farmakokinetika loratadina poveča njegovo variabilnost v osebah.
English: In conclusion, the submitted study demonstrates the bioequivalence of Loratadine Sandoz 10mg tablets to the reference product for AUC0-t and AUC0-∞ of loratadine, but not for the Cmax parameter.
Slovenian: V zaključku je predložena študija dokazala bioekvivalenco zdravila Loratadine Sandoz 10 mg tablete z referenčnim zdravilom za AUC0-t in AUC0-∞ za loratadin, vendar ne za parameter Cmax.