FrancophonIA/ELRC3.0 huggingface dataset:
English: The Enzepi 40,000 units gastro-resistant hard capsule has a blue opaque cap and a white opaque body with ‘Enzepi 40' printed on it and contains light-brown gastro-resistant granules.
Slovenian: Gastrorezistentna trda kapsula Enzepi 40.000 enot ima modro neprosojno kapico in belo neprosojno telo z natisom »Enzepi 40« ter vsebuje svetlo rjava gastrorezistentna zrnca.
English: The Enzepi 25,000 units gastro-resistant hard capsule has a green opaque cap and a white opaque body with ‘Enzepi 25' printed on it and contains light-brown gastro-resistant granules.
Slovenian: Gastrorezistentna trda kapsula Enzepi 25.000 enot ima zeleno neprosojno kapico in belo neprosojno telo z natisom »Enzepi 25« ter vsebuje svetlo rjava gastrorezistentna zrnca.
English: Hard capsule with a blue opaque cap and a white opaque body, printed with “Enzepi 40” and containing light-brown gastro-resistant granules.
Slovenian: Trda kapsula z modro neprosojno kapico, belim neprosojnim telesom in napisom »Enzepi 40«, ki vsebuje svetlo rjava gastrorezistentna zrnca.
English: Enzepi 40,000 units gastro-resistant hard capsules
Slovenian: Enzepi 40.000 enot gastrorezistentne trde kapsule
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - 40,000 unit strength
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA - Jakost 40.000 enot
English: Enzepi 10,000 units gastro-resistant hard capsules
Slovenian: Enzepi 10.000 enot gastrorezistentne trde kapsule
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 5,000 unit strength
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA - Jakost 5.000 enot
English: The Enzepi 5,000 units gastro-resistant hard capsule has a white opaque cap and a white opaque body with ‘Enzepi 5' printed on it and contains light-brown gastro-resistant granules.
Slovenian: Gastrorezistentna trda kapsula Enzepi 5.000 enot ima belo neprosojno kapico in belo neprosojno telo z natisom »Enzepi 5« ter vsebuje svetlo rjava gastrorezistentna zrnca.
English: not less than 410 Ph. Eur.
Slovenian: 410 enot po Ph. Eur..
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 83,7 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti: lipolitična aktivnost:
English: One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities:
Slovenian: Ena kapsula vsebuje 39,8 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti:
English: Hard capsule with a green opaque cap and a white opaque body, printed with “Enzepi 25” and containing light-brown gastro-resistant granules.
Slovenian: Trda kapsula z zeleno neprosojno kapico, belim neprosojnim telesom in napisom »Enzepi 25«, ki vsebuje svetlo rjava gastrorezistentna zrnca.
English: The Enzepi 10,000 units gastro-resistant hard capsule has a yellow opaque cap and a white opaque body with ‘Enzepi 10' printed on it and contains light-brown gastro-resistant granules.
Slovenian: Gastrorezistentna trda kapsula Enzepi 10.000 enot ima rumeno neprosojno kapico in belo neprosojno telo z natisom »Enzepi 10« ter vsebuje svetlo rjava gastrorezistentna zrnca.
English: not less than 410 units*
Slovenian: 410 enot*.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 209.3 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 209,3 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti: lipolitična aktivnost:
English: NAME OF THE MEDICINAL PRODUCT Enzepi 25,000 units gastro-resistant hard capsules Pancreas powder
Slovenian: Enzepi 25.000 enot gastrorezistentne trde kapsule uprašeni pankreas
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 334,9 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti: lipolitična aktivnost:
English: Hard capsule with a yellow opaque cap and a white opaque body, printed with “Enzepi 10” and containing light-brown gastro-resistant granules.
Slovenian: Trda kapsula z rumeno neprosojno kapico, belim neprosojnim telesom in napisom »Enzepi 10«, ki vsebuje svetlo rjava gastrorezistentna zrnca.
English: Hard capsules with a white opaque cap and a white opaque body, printed with “Enzepi 5” and containing light-brown gastro-resistant granules.
Slovenian: Trda kapsula z belo neprosojno kapico, belim neprosojnim telesom in napisom »Enzepi 5«, ki vsebuje svetlo rjava gastrorezistentna zrnca.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10,000 unit strength
Slovenian: PODATKI NA ZUNANJI OVOJNINI KARTONSKA ŠKATLA - Jakost 10.000 enot
English: Enzepi 5,000 units gastro-resistant hard capsules
Slovenian: Enzepi 5.000 enot gastrorezistentne trde kapsule
English: units amylase:
Slovenian: amilaza:
English: EU/1/16/1113/013 20 gastro-resistant hard capsules EU/1/16/1113/014 50 gastro-resistant hard capsules EU/1/16/1113/015 100 gastro-resistant hard capsules EU/1/16/1113/016 200 gastro-resistant hard capsules
Slovenian: EU/1/16/1113/013 20 gastrorezistentnih trdih kapsul EU/1/16/1113/014 50 gastrorezistentnih trdih kapsul EU/1/16/1113/015 100 gastrorezistentnih trdih kapsul EU/1/16/1113/016 200 gastrorezistentnih trdih kapsul
English: EU/1/16/1113/005 20 gastro-resistant hard capsules EU/1/16/1113/006 50 gastro-resistant hard capsules EU/1/16/1113/007 100 gastro-resistant hard capsules EU/1/16/1113/008 200 gastro-resistant hard capsules
Slovenian: EU/1/16/1113/005 20 gastrorezistentnih trdih kapsul EU/1/16/1113/006 50 gastrorezistentnih trdih kapsul EU/1/16/1113/007 100 gastrorezistentnih trdih kapsul EU/1/16/1113/008 200 gastrorezistentnih trdih kapsul
English: Enzepi 25,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, yellow iron oxide (E172), indigotine E132.
Slovenian: Enzepi 25.000 enot: hipromeloza, karagenan (E407), kalijev klorid, titanov dioksid (E171), karnauba vosek, voda, rumeni železov oksid (E172), indigotin (E132); Enzepi 40.000 enot: hipromeloza, karagenan (E407), kalijev klorid, titanov dioksid (E171), karnauba vosek, voda, indigotin (E132); o tiskarsko črnilo: šelak, propilenglikol, indigotin (E132).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 39,8 mg uprašenega pankreasa prašičjega izvora z naslednjimi stopnjami encimske aktivnosti: lipolitična aktivnost:
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING BOTTLE LABEL - 5,000 unit strength
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA PLASTENKI - Jakost 5.000 enot
English: NAME OF THE MEDICINAL PRODUCT Enzepi 40,000 units gastro-resistant hard capsules Pancreas powder
Slovenian: Enzepi 40.000 enot gastrorezistentne trde kapsule uprašeni pankreas
English: NAME OF THE MEDICINAL PRODUCT Enzepi 5,000 units gastro-resistant hard capsules Pancreas powder
Slovenian: Enzepi 5.000 enot gastrorezistentne trde kapsule uprašeni pankreas
English: not less than 1,600 units*
Slovenian: 1.600 enot*,
English: Abdominal pain upper Dyspepsia
Slovenian: KG Pinnauallee 4
English: EU/1/16/1113/009 20 gastro-resistant hard capsules EU/1/16/1113/010 50 gastro-resistant hard capsules EU/1/16/1113/011 100 gastro-resistant hard capsules EU/1/16/1113/012 200 gastro-resistant hard capsules
Slovenian: EU/1/16/1113/009 20 gastrorezistentnih trdih kapsul EU/1/16/1113/010 50 gastrorezistentnih trdih kapsul EU/1/16/1113/011 100 gastrorezistentnih trdih kapsul EU/1/16/1113/012 200 gastrorezistentnih trdih kapsul
English: NAME OF THE MEDICINAL PRODUCT Enzepi 10,000 units gastro-resistant hard capsules Pancreas powder
Slovenian: Enzepi 10.000 enot gastrorezistentne trde kapsule uprašeni pankreas
English: EU/1/16/1113/001 20 gastro-resistant hard capsules EU/1/16/1113/002 50 gastro-resistant hard capsules EU/1/16/1113/003 100 gastro-resistant hard capsules EU/1/16/1113/004 200 gastro-resistant hard capsules
Slovenian: EU/1/16/1113/001 20 gastrorezistentnih trdih kapsul EU/1/16/1113/002 50 gastrorezistentnih trdih kapsul EU/1/16/1113/003 100 gastrorezistentnih trdih kapsul EU/1/16/1113/004 200 gastrorezistentnih trdih kapsul
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - 10,000 unit strength
Slovenian: PODATKI NA PRIMARNI OVOJNINI NALEPKA NA PLASTENKI - Jakost 10.000 enot
English: 1 Following the outcome of an Article 31 referral procedure on tolperisone-containing medicinal products, for which a Commission decision was adopted in January 2013.
Slovenian: 1 V skladu z izidom napotitvenega postopka v skladu s členom 31 za zdravila, ki vsebujejo tolperizon, za katerega je bil sklep Komisije sprejet januarja 2013.
English: • The Committee considered the notification of the referral triggered by Hungary under Article 29(4) of Directive 2001/83/EC where Germany raised objections that were considered to be a potential serious risk to public health;
Slovenian: • odbor je upošteval obvestilo o napotitvenem postopku, ki ga je sprožila Madžarska skladno s členom 29(4) Direktive 2001/83/ES in v katerem je Nemčija izrazila pomisleke, ki bi lahko bili povezani z resnim tveganjem za javno zdravje;
English: The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure.
Slovenian: Skupina CMDh je zato zadevo napotila na odbor CHMP na podlagi napotitvenega postopka iz člena 29(4).
English: During the CMDh2 referral procedure that followed the mutual recognition procedure (MRP), no consensus could be reached as the objecting member state maintained its objection, which was thought to represent a potential serious risk to public health.
Slovenian: Med napotitvenim postopkom skupine CMDh2, ki je sledil postopku z medsebojnim priznavanjem, ni bilo mogoče doseči soglasja, saj je omenjena država članica vztrajala pri pomisleku, ki bi lahko bil povezan z resnim tveganjem za javno zdravje.
English: The marketing authorisation application (MAA) for Merisone was submitted under Article 10(1) of Directive 2001/83/EC (i.e. a generic application), vis-à-vis the reference medicinal product Mydeton (Gedeon Richter Plc).
Slovenian: Vloga za pridobitev dovoljenja za promet z zdravilom Merisone je bila predložena v skladu s členom 10(1) Direktive 2001/83/ES (tj. generična vloga) in je temeljila na referenčnem zdravilu Mydeton (Gedeon Richter Plc).
English: • The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the bioequivalence of Merisone with respect to the reference medicinal product;
Slovenian: • odbor je pregledal odgovore, ki jih je predložil predlagatelj, da bi razrešil odprta vprašanja v zvezi z biološko enakovrednostjo zdravila Merisone in referenčnega zdravila;
English: Therefore it was considered that fasting bioequivalence studies are expected to be more sensitive to detect formulation differences.
Slovenian: Zato so ocenili, da je mogoče pričakovati, da so bioekvivalenčne študije v pogojih na tešče bolj občutljive za zaznavanje razlik med formulacijami.
English: Since the effect of these excipients would be diluted in the presence of food, it was considered unlikely that excipients such as mannitol would be larger in fed conditions compared to fasting conditions, given that the effect of mannitol is based on its osmotic effect.
Slovenian: Ker bi se učinek teh pomožnih snovi ob prisotnosti hrane zmanjšal, so menili, da ni verjetno, da bi bil vpliv pomožnih snovi, kot je manitol, v pogojih na poln želodec večji kot v pogojih na tešče, saj učinek manitola temelji na osmotskem učinku.
English: Bioequivalence was demonstrated with regard to the primary pharmacokinetic parameters, i.e. AUC and Cmax, in the study with the 150 mg tablet, as the 90% CIs were within the required 80-125% limits.
Slovenian: Biološko enakovrednost so dokazali pri primarnih farmakokinetičnih parametrih, tj. AUC in Cmaks, v študiji s 150-miligramsko tableto, kjer je bil 90-odstotni IZ znotraj zahtevanih mejnih vrednosti 80-125 %.
English: The active substance of Merisone is tolperisone hydrochloride, which is a centrally acting muscle relaxant indicated for the symptomatic treatment of post-stroke spasticity in adults.
Slovenian: Zdravilna učinkovina v zdravilu Merisone je tolperizonijev klorid, mišični relaksant, ki deluje na osrednje živčevje in je indiciran za simptomatsko zdravljenje spastičnosti, ki je posledica možganske kapi, pri odraslih.
English: The CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group, for Merisone and associated names (see Annex I).
Slovenian: je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki kot zadnje različice, dogovorjene med postopkom Usklajevalne skupine, za zdravilo Merisone in povezana imena (glejte Prilogo I).
English: Furthermore it was argued that serious concerns remained as to whether the test product in this case (that is advised to be taken concomitantly with food), would be bioequivalent under fed conditions, given that the results of the bioequivalence studies under fasted conditions were borderline.
Slovenian: Poleg tega je trdila, da še vedno obstajajo resni pomisleki glede tega, ali bi v tem primeru preiskovano zdravilo (za katerega se priporoča jemanje skupaj s hrano) bilo biološko enakovredno v pogojih na poln želodec, saj so bili rezultati bioekvivalenčnih študij v pogojih na tešče na meji.
English: The applicant highlighted that, at the time the bioequivalence studies were performed, the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention that the food effect was significant.
Slovenian: Predlagatelj je poudaril, da v času izvajanja bioekvivalenčnih študij povzetek glavnih značilnosti zdravila za referenčno zdravilo ni vseboval nobenih priporočil v zvezi s hrano niti navedbe o tem, da je vpliv hrane pomemben.
English: Taking into account that the MAH had submitted data which showed that tolperisone is a highly soluble and highly permeable active substance, neither solubility nor dissolution was considered to be a limiting factor in terms of in vivo absorption.
Slovenian: Glede na to, da so podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom, pokazali, da je tolperizon lahko topna in zelo permeabilna zdravilna učinkovina, se niti topnost niti raztapljanje ne štejeta za omejitveni dejavnik v smislu absorpcije in vivo.
English: • Therefore, the Committee concluded by majority that the bioequivalence studies conducted in the fasting state give sufficient evidence to conclude on the bioequivalence also in the fed state since Merisone contains a highly soluble and highly permeable active substance, and pharmacokinetic principles and convincing experimental evidence suggest that the food effect of this active substance is formulation independent.
Slovenian: • odbor je zato z večino zaključil, da sta bioekvivalenčni študiji, izvedeni v pogojih na tešče, zagotovili zadostne dokaze, da je mogoče sklepati o biološki enakovrednosti tudi v pogojih na poln želodec, saj zdravilo Merisone vsebuje lahko topno in zelo permeabilno zdravilno učinkovino, načela farmakokinetike in prepričljivi eksperimentalni dokazi pa kažejo, da vpliv hrane na to zdravilno učinkovino ni odvisen od formulacije;
English: The objecting concerned member state (CMS) was of the view that a similar extent of the food effect that was shown for the two different products referred to above, does not have to hold true for this generic formulation since it has not been proven that the food effect is a characteristic of the active substance and not a formulation related factor.
Slovenian: Zadevna država članica, ki je izrazila pomisleke, je menila, da ni nujno, da podoben obseg vpliva hrane, ki so ga opazili pri dveh različnih zdravilih, omenjenih zgoraj, velja tudi za to generično formulacijo, saj ni bilo dokazano, da je vpliv hrane značilen za zdravilno učinkovino, in ni zgolj dejavnik, povezan s formulacijo.
English: The majority of the CHMP members agreed that in vivo dissolution differences between formulations are likely to be less apparent and more difficult to observe in fed conditions since gastric emptying time is longer in the fed state than in the fasting state.
Slovenian: Večina članov odbora CHMP se je strinjala, da so razlike v raztapljanju in vivo med formulacijama v pogojih na poln želodec verjetno manj očitne in jih je težje opaziti, saj je čas prehajanja skozi želodec v pogojih na poln želodec daljši kot v pogojih na tešče.
English: As there is no evidence that the food-effect is formulation dependent and the formulation is a conventional one, some of the PKWP members considered that a bioequivalence study in the fasting state was acceptable in this case.
Slovenian: Ker ni na voljo nobenih dokazov o tem, da je vpliv hrane odvisen od formulacije, in ker gre za običajno formulacijo, so nekateri člani delovne skupine za farmakokinetiko menili, da je bioekvivalenčna študija v pogojih na tešče v tem primeru sprejemljiva.
English: As there is no evidence that the food-effect is formulation dependent, the majority of the CHMP concluded that the bioequivalence studies conducted in the fasting state, which is considered to be the most sensitive condition, would give sufficient evidence to conclude on the bioequivalence in both the fasting and fed states in this particular case.
Slovenian: Glede na to, da ni dokazov o tem, da je vpliv hrane odvisen od formulacije, je večina članov odbora CHMP zaključila, da sta bioekvivalenčni študiji, izvedeni v pogojih na tešče, ki veljajo za najobčutljivejše, zagotovili zadostne dokaze, da je mogoče zaključiti, da je v tem primeru zdravilo biološko enakovredno tako v pogojih na tešče kot na poln želodec.
English: Since the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention a food effect, the MAA that was submitted for Merisone included two bioequivalence studies with 50 and 150 mg tolperisone film-coated tablets conducted under fasting conditions with 52 volunteers each.
Slovenian: Povzetek glavnih značilnosti zdravila za referenčno zdravilo ni vseboval nobenih priporočil glede hrane niti navedbe o vplivu hrane, zato sta bili k vlogi za pridobitev dovoljenja za promet z zdravilom, ki je bila predložena za Merisone, priloženi dve bioekvivalenčni študiji s 50- in 150-miligramskimi filmsko obloženimi tabletami tolperizona, ki so ju izvedli v pogojih na tešče, v vsaki pa je sodelovalo 52 prostovoljcev.
English: Taking into account all the evidence and arguments presented, the majority of the CHMP noted that that bioequivalence had been demonstrated in the fasting state for tolperisone, which is highly soluble and highly permeable active substance, demonstrating high within-subject variability.
Slovenian: Ob upoštevanju vseh predstavljenih dokazov in argumentov je večina članov odbora CHMP izpostavila, da je bila biološka enakovrednost tolperizona dokazana v pogojih na tešče, pri čemer je tolperizon lahko topna in zelo permeabilna zdravilna učinkovina z dokazano veliko spremenljivostjo pri posamezniku.
English: The Pharmacokinetics Working Party (PKWP) was also consulted to seek their view on whether there is any scientific reasoning that tolperisone (classified as a highly variable drug as the within-subject variability of the Cmax of the reference medicinal product was 46.99%) may have the option of showing bioequivalence in either the fasted or fed state.
Slovenian: Posvetovali so se tudi z delovno skupino za farmakokinetiko in jo zaprosili za mnenje o tem, ali obstajajo kakršni koli znanstveni argumenti, ki podpirajo sklep, da se lahko biološka enakovrednost tolperizona (ki je zelo spremenljivo zdravilo, saj je bila spremenljivost Cmaks referenčnega zdravila pri posamezniku 46,99-odstotna) dokaže v pogojih na tešče ali na poln želodec.
English: Other PKWP members were of the view that a fed study would not have been required only if the effects of food were known to be solely hepatic, which however was considered to be insufficiently supported, and since the food effect for tolperisone was considered to be significantly high, a study in a fed state should have been performed.
Slovenian: Preostali člani delovne skupine za farmakokinetiko pa so menili, da študija v pogojih na poln želodec ne bi bila potrebna samo, če bi bilo dokazano, da je vpliv hrane povezan izključno z jetri, za kar pa ni zadostnih dokazov, in da bi bilo glede na to, da je bil vpliv hrane na tolperizon ocenjen kot precejšen, treba izvesti študijo v pogojih na poln želodec.
English: The information that was introduced in the SmPC of tolperisone was based on two well-designed studies conducted with different formulations of tablets, which showed that compared to the fasting state, fat-rich food increases the bioavailability of tolperisone by about
Slovenian: Informacije, ki so bile vključene v povzetek glavnih značilnosti zdravila za tolperizon, so temeljile na dveh dobro zasnovanih študijah, izvedenih z različnimi formulacijami tablet, ki sta pokazali, da hrana, bogata z maščobami, poveča biološko uporabnost tolperizona za približno 100 % v primerjavi z zaužitjem na tešče.
English: Although the results of the bioequivalence studies were considered to be borderline by the objecting CMS, the applicant argued that the second bioequivalence study was a replicate design study where it was shown that tolperisone is a highly variable drug - the within-subject variability of the reference medicinal product Cmax was 46.99%.
Slovenian: Zadevna država članica, ki je izrazila pomisleke, je menila, da so rezultati bioekvivalenčnih študij na meji, vendar je predlagatelj ugovarjal, da je bila druga bioekvivalenčna študija izvedena kot študija s ponovitvami, ki je pokazala, da je tolperizon zelo spremenljivo zdravilo - spremenljivost Cmaks referenčnega zdravila pri posamezniku je bila 46,99-odstotna.
English: Therefore the objecting member state was of the view that the two bioequivalence submitted with the 50 and 150mg tolperisone tablets under fasting conditions were not sufficient, and that bioequivalence should be demonstrated under fed conditions.
Slovenian: Država članica, ki je izrazila pomisleke, je zato menila, da bioekvivalenčni študiji v pogojih na tešče, predloženi za 50- in 150-miligramske tablete tolperizona, ne zadostujeta in da je treba biološko enakovrednost dokazati v pogojih na poln želodec.
English: The CHMP also noted that the excipients mannitol and betaine found in the product subject to the referral but not in the reference medicinal product, had no effect on the bioequivalence of these products in fasting state.
Slovenian: Odbor CHMP je upošteval tudi, da pomožni snovi manitol in betain, ki ju vsebuje zdravilo, ki je predmet napotitve, ne pa tudi referenčno zdravilo, nista vplivali na biološko enakovrednost teh zdravil v pogojih na tešče.
English: In the study with the 50 mg tablet, bioequivalence was not demonstrated as the upper limit of the Cmax was outside the upper band, i.e.
Slovenian: V študiji s 50-miligramsko tableto biološke enakovrednosti niso dokazali, saj je bila zgornja meja Cmaks zunaj zgornje meje razpona, tj. 125,49 %.