FrancophonIA/ELRC3.0 huggingface dataset:
English: It is acknowledged that sorbitol can increase gastrointestinal motility, as a consequence of its osmotic effect, thereby reducing gastrointestinal transit time, which in turn can reduce drug absorption.
Slovenian: Znano je, da lahko sorbitol zaradi svojega osmotskega učinka poveča motiliteto prebavil, s čimer zmanjšuje čas prehoda skozi prebavila, kar lahko zmanjša absorpcijo zdravila.
English: The cited reference medicinal product Prednisolone Tablets Sovereign (5 mg soluble tablet), does not contain sorbitol and is recommended to be dissolved in water at the time of administration.
Slovenian: Navedeno referenčno zdravilo Prednisolone Tablets Sovereign (5-miligramska tableta za peroralno raztopino) ne vsebuje sorbitola in priporočeno je, da se v času jemanja zdravilo raztopi v vodi.
English: However if the excipients may affect gastrointestinal transit (e.g. sorbitol, mannitol, etc.), absorption (e.g. surfactants or excipients that may affect transport proteins), in vivo solubility (e.g. cosolvents) or in vivo stability of the active substance, a bioequivalence study should be conducted, unless the differences in the amounts of these excipients can be adequately justified by reference to other data.
Slovenian: Če pa lahko pomožne snovi vplivajo na prehod skozi prebavila (npr. sorbitol, manitol itd.), absorpcijo (npr. površinsko aktivne snovi ali pomožne snovi, ki bi lahko vplivale na transportne beljakovine), topnost in vivo (npr. pomožna topila) ali in vivo stabilnost zdravilne učinkovine, je treba opraviti študijo biološke enakovrednosti, razen če je mogoče razlike v količinah teh pomožnih snovi zadovoljivo upravičiti s sklicevanjem na druge podatke.
English: The authors of the study found that there was no difference in dyspnoea scores and concluded therapeutic equivalence, implying also bioequivalence.
Slovenian: Avtorji študije so ugotovili, da ni bilo razlik v ocenah dispneje in sklepali na terapevtsko enakovrednost, ki nakazuje tudi biološko enakovrednost.
English: The mutual recognition marketing authorisation application (MAA) for Okrido was submitted in the UK as a generic medicinal product under article 10(1) of Directive 2001/83/EC, and the marketing authorisation was granted by the UK on the basis of a biowaiver.
Slovenian: Vloga za pridobitev dovoljenja za promet z zdravilom po postopku z medsebojnim priznavanjem za zdravilo Okrido je bila vložena v Združenem kraljestvu kot generično zdravilo v skladu s členom 10(1) Direktive 2001/83/ES, dovoljenje za promet z zdravilom pa je bilo v Združenem kraljestvu izdano na podlagi izvzetja študij biološke enakovrednosti.
English: If the test product is an aqueous oral solution at time of administration and contains an active substance in the same concentration as an approved oral solution, bioequivalence studies may be waived.
Slovenian: Če je testno zdravilo v času dajanja vodna peroralna raztopina in vsebuje zdravilno učinkovino v enaki koncentraciji kot odobrena peroralna raztopina, je mogoče študije biološke enakovrednosti izvzeti.
English: The excipient sorbitol is available in Okrido (500 mg/ml) and not in the reference medicinal product.
Slovenian: Pomožna snov sorbitol je na voljo v zdravilu Okrido (500 mg/ml), ne pa v referenčnem zdravilu.
English: However, during the mutual recognition procedure (MRP), the member states Germany and The Netherlands were of the view that the claim for a BSC-based biowaiver had not been adequately justified, and that on this basis Okrido could be a potential serious risk to public health.
Slovenian: Vendar pa sta bili v času postopka z medsebojnim priznavanjem državi članici Nemčija in Nizozemska mnenja, da zahteva po izvzetju študij biološke enakovrednosti na podlagi najboljše podporne oskrbe ni bila zadovoljivo upravičena in da lahko zato zdravilo Okrido predstavlja možno resno tveganje za javno zdravje.
English: However taking into account the high solubility, and the rapid and almost complete absorption along the entire length of the small intestine, the CHMP was of the view that the amount of prednisolone absorbed will not be significantly affected by decreased residence time of the administered dose in any segment of the intestine, or reduced intestinal residence time overall.
Slovenian: Vendar pa je odbor CHMP ob upoštevanju velike topnosti in hitre ter skoraj popolne absorpcije vzdolž celotne dolžine tankega črevesa menil, da zmanjšani čas zadrževanja danega odmerka v katerem koli delu črevesa ali pa celokupni zmanjšani čas zadrževanja v črevesu ne bo bistveno vplival na količino absorbiranega prednizolona.
English: During the CMD-h referral procedure that followed, no consensus could be reached as The Netherlands maintained their objection.
Slovenian: V času napotitvenega postopka na skupino za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD-h), ki je sledil, ni bilo mogoče doseči soglasja, saj je Nizozemska vztrajala pri svojem ugovoru.
English: According to the CHMP Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 rev 1), a drug substance is considered as highly soluble if the highest single dose administered as immediate release formulation(s) is completely dissolved in 250 ml of buffers within the range of pH 1 - 6.8 at 37±1 °C.
Slovenian: Skladno s Smernico odbora CHMP o preiskovanju biološke enakovrednosti (CPMP/EWP/QWP/1401/98 rev 1) se učinkovina šteje za zelo lahko topno, če se najvišji enkratni odmerek, dan kot pripravek (pripravki) s takojšnjim sproščanjem, v celoti raztopi v 250 ml pufrov v razponu pH od 1-6,8 pri 37 ± 1 °C.
English: • The Committee considered that the biowaiver applied in place of an in vivo bioavailability study for Okrido was acceptable as:
Slovenian: • odbor je presodil, da je izvzetje študij biološke enakovrednosti na mestu in vivo študije biološke razpoložljivosti za zdravilo Okrido sprejemljivo, ker:
English: The MAH has submitted published clinical data (Lucas-Bouwmann 20011) to support the lack of a clinically relevant effect of sorbitol on prednisolone absorption.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil objavljene klinične podatke (LucasBouwmann 20011) v podporo pomanjkanju klinično pomembnega učinka sorbitola na absorpcijo prednizolona.
English: One of the key excipients in Okrido is sorbitol which is included as a sweetener and is present at a concentration of 500 mg/ml (total amount at the highest dose being 8.3g) in the medicinal product.
Slovenian: Ena od ključnih pomožnih snovi v zdravilu Okrido je sorbitol, ki je vključen kot sladilo in je v zdravilu prisoten v koncentraciji 500 mg/ml (pri čemer je skupna količina pri najvišjem odmerku 8,3 g).
English: Following transport across the Caco-2 cell monolayer, prednisolone was recovered in the range of 84% to 106% of the applied dose, whether as prednisolone sodium phosphate, Okrido oral solution or the reference medicinal product Prednisolone Sovereign soluble tablet.
Slovenian: Po transportu preko enojne plasti celice Caco-2 se je prednizolon pojavil v obsegu od 84 % do 106 % danega odmerka, ko je bil dan kot prednizolon natrijev fosfat, zdravilo Okrido peroralna raztopina ali referenčno zdravilo Prednisolone Sovereign tableta za peroralno raztopino.
English: The Scientific Expert Statements provided by the MAH, suggest that prednisolone is rapidly and almost completely absorbed passively from the upper gastrointestinal tract (stomach, duodenum and small intestines) before reaching the colon, where sorbitol at a sufficiently high concentration may exert some osmotic laxative effect.
Slovenian: Znanstvene strokovne izjave, ki jih je predložil imetnik dovoljenja za promet z zdravilom, navajajo, da se prednizolon hitro in skoraj v celoti pasivno absorbira v zgornjem delu gastrointestinalnega trakta (želodec, dvanajsternik in tanko črevo), preden doseže debelo črevo, kjer ima lahko sorbitol v dovolj visoki koncentraciji določen osmotski odvajalni učinek.
English: The indications and posology are consistent with those of the cited reference medicinal product Prednisolone Tablets Sovereign (5 mg soluble tablet).
Slovenian: Indikacije in odmerjanje zdravila so skladni z indikacijami in odmerjanjem navedenega referenčnega zdravila Prednisolone Tablets Sovereign (5miligramska tableta za peroralno raztopino).
English: - Prednisolone is rapidly and almost completely absorbed in the upper gastrointestinal tract.
Slovenian: - se prednizolon hitro in skoraj v celoti absorbira v zgornjem delu gastrointestinalnega trakta;
English: Based on the submitted in-vitro Caco-2 monolayer cell model (permeability assay model), published literature and the oral explanation by the MAH on 26 June 2013, the CHMP considers that the biowaiver is acceptable, and therefore concluded that the benefit-risk balance for Okrido in the applied indications is favourable.
Slovenian: Na podlagi predloženega enoplastnega in vitro celičnega modela Caco-2 (model za oceno permeabilnosti), objavljene literature in ustnega pojasnila imetnika dovoljenja za promet z zdravilom, ki ga je podal dne 26. junija 2013, odbor CHMP meni, da je izvzetje študij biološke enakovrednosti sprejemljivo, in je zato sklenil, da je razmerje med koristmi in tveganji za zdravilo Okrido pri uporabljenih indikacijah ugodno.
English: The applicant has submitted the results of an in vitro investigation of the permeability of prednisolone using validated methodology involving the Caco-2 monolayer cell model.
Slovenian: Predlagatelj je predložil rezultate in vitro preiskave permeabilnosti prednizolona z uporabo validirane metodologije, ki vključuje enoplastni celični model Caco-2.
English: The same requirements for similarity in excipients apply for oral solutions as for Biowaivers (see Appendix III, Section IV.2 Excipients).'
Slovenian: Zahteve, ki veljajo za podobnost pri pomožnih snoveh, veljajo tako za peroralne raztopine kot za izvzetja študij biološke enakovrednosti (glejte Dodatek III, Poglavje IV. 2 Pomožne snovi).‟
English: The MAH has also provided the abstract of an observational study (Staubach 20102) to support the clinical efficacy of the oral prednisolone solution containing sorbitol on emergency care patients presenting with urticaria and/or Quincke´s oedema.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil tudi izvleček opazovalne študije (Staubach 20102) v podporo klinični učinkovitosti peroralne raztopine prednizolona, ki vsebuje sorbitol, pri bolnikih, ki so prejemali nujno zdravstveno oskrbo zaradi urtikarije in/ali Quinckejevega edema.
English: therapy with prednisolone, and safety and tolerability were shown.
Slovenian: zdravljenjem s prednizolonom, dokazali so tudi varnost in prenašanje zdravila.
English: The MAH has provided solubility data which show that prednisolone sodium phosphate (PSP) is completely dissolved in water at a concentration of ~ 8.9 mg/ml, and that prednisolone remains in solution across the pH range of 1 to 8.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil podatke o topnosti, ki kažejo, da se prednizolon natrijev fosfat (PSP) v celoti raztopi v vodi pri koncentraciji ~ 8,9 mg/ml in da prednizolon ostane v raztopini v razponu pH od 1 do 8.
English: Indeed Chen et al3 (2007)4 showed that in the presence of sorbitol, Cmax and AUC of ranitidine (BCS class III, low permeability substance) were significantly reduced while only the Cmax of metoprolol (BCS class I
Slovenian: Res so Chen in sod.3 (2007)4 dokazali, da so bile ob prisotnosti sorbitola vrednosti Cmax in AUC ranitidina (razred III po biofarmacevtskem sistemu klasifikacije, snov z nizko permeabilnostjo) bistveno znižane, medtem ko se je pri metoprololu pokazal podoben vpliv le na vrednost Cmax (razred I po biofarmacevtskem sistemu klasifikacije, snov z visoko permeabilnostjo).
English: The results indicate that the permeability of prednisolone is high, whether applied directly, as Okrido or prednisolone soluble tablets.
Slovenian: Rezultati prikazujejo visoko permeabilnost prednizolona, danega neposredno kot zdravilo Okrido ali kot tablete prednizolona za peroralno raztopino.
English: Crushed prednisolone tablets were compared to prednisolone syrup (with sorbitol), in children with acute asthma, using dyspnoea as clinical end point.
Slovenian: Zdrobljene tablete prednizolona so primerjali s prednizolonom v obliki sirupa (s sorbitolom) pri otrocih z akutno astmo, pri čemer so za oceno kliničnega končnega učinka uporabili dispnejo.
English: The active ingredient in Okrido, prednisolone sodium phosphate, is ‘freely soluble in water' (Ph Eur).
Slovenian: Aktivna učinkovina v zdravilu Okrido, prednizolon natrijev sulfat, je „dobro topna v vodi” (Evropska farmakopeja).
English: The permeability data is reflective of the available literature, which indicates that prednisolone is rapidly and almost completely absorbed across the upper gastrointestinal tract.
Slovenian: Podatki o permeabilnosti odražajo razpoložljive podatke iz literature, ki navajajo, da se prednizolon hitro in skoraj v celoti absorbira v vsem zgornjem delu gastrointestinalnega trakta.
English: Okrido is an oral solution containing 6 mg/ml of the glucocorticoid prednisolone, as prednisolone sodium phosphate (PSP).
Slovenian: Okrido je peroralna raztopina, ki vsebuje 6 mg/ml glukokortikoida prednizolona v obliki prednizolon natrijevega fosfata (PSP).
English: The permeability data is reflective of the available literature data, which indicate that prednisolone is rapidly and almost completely absorbed passively from the upper gastrointestinal tract.
Slovenian: Podatki o permeabilnosti odražajo razpoložljive podatke iz literature, ki navajajo, da se prednizolon hitro in skoraj v celoti pasivno absorbira v zgornjem delu gastrointestinalnega trakta.
English: 4 Chen M. Straughn A, Sadrieh N. et al (2007).
Slovenian: Pharm. Res. 24, 73-80. 4 Chen M. Straughn A, Sadrieh N. et al (2007).
English: Solubility and dissolution are not considered to be a limiting factor in terms of in vivo absorption.
Slovenian: Topnost in raztapljanje se ne štejeta za omejitveni dejavnik v smislu absorpcije in vivo.
English: Solubility and/or dissolution are therefore not considered to be a limiting factor in terms of in vivo absorption.
Slovenian: Topnost in/ali raztapljanje se zato ne štejeta za omejitveni dejavnik v smislu absorpcije in vivo.
English: - Prednisolone (as sodium phosphate) exhibits high permeability as determined by the in vitro Caco-2 cell permeability model, and the permeability of Okrido is unaffected by the excipient sorbitol.
Slovenian: - prednizolon (kot natrijev fosfat) izkazuje visoko permeabilnost, kot je dokazal in vitro celični model permeabilnosti Caco-2, na permeabilnost zdravila Okrido pa pomožna snov sorbitol ne vpliva;
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 procedure as mentioned in Annex III of this Opinion.
Slovenian: • odbor je zato sklenil, da je izvzetje študij biološke enakovrednosti upravičeno in da je razmerje med tveganji in koristmi za zdravilo Okrido za uporabljene indikacije ugodno; je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, za katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostajajo enaki kot zadnje različice, pripravljene med postopkom skupine za usklajevanje, kot je navedeno v Prilogi III tega mnenja.
English: Both Okrido and the reference product are dissolved in water before administration and are considered to be oral solutions, which exhibit high solubility across the gastrointestinal physiological pH range.
Slovenian: Zdravilo Okrido in referenčno zdravilo je treba pred dajanjem raztopiti v vodi in se štejeta za peroralni raztopini, ki izkazujeta veliko topnost v razponu fiziološkega pH prebavil.
English: - Both Okrido and the reference product are dissolved in water before administration and are considered to be oral solutions, which exhibits high solubility across the gastrointestinal physiological pH range.
Slovenian: - je zdravilo Okrido in referenčno zdravilo treba pred dajanjem raztopiti v vodi in se štejeta za peroralni raztopini, ki izkazujeta veliko topnost v razponu fiziološkega pH prebavil.
English: Permeability has been investigated using in vitro Caco-2 monolayer cell model and the results showed that prednisolone exhibits high permeability characteristic of BCS class I substances, and also that the permeability of prednisolone is not significantly affected by the excipient sorbitol in Okrido.
Slovenian: Permeabilnost so preiskovali z uporabo enoplastnega in vitro celičnega modela Caco-2, rezultati pa so pokazali, da prednizolon izkazuje visoko permeabilnost, značilno za snovi razreda I po biofarmacevtskem sistemu klasifikacije (BCS), in da pomožna snov sorbitol v zdravilu Okrido ne vpliva bistveno na permeabilnost prednizolona.
English: In summary, the results of the in vitro investigation of the permeability of prednisolone using the Caco-2 cell model showed that prednisolone exhibits high permeability, characteristic of BCS class I substances, and also that the permeability of prednisolone is not affected by the excipient sorbitol in Okrido.
Slovenian: Rezultati in vitro preiskave permeabilnosti prednizolona z uporabo celičnega modela Caco-2 so pokazali, da prednizolon izkazuje visoko permeabilnost, značilno za snovi razreda I po biofarmacevtskem sistemu klasifikacije (BCS), ter da na permeabilnost prednizolona ne vpliva pomožna snov sorbitol v zdravilu Okrido.
English: The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure.
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini je zato zadevo napotila na odbor CHMP prek napotitvenega postopka po členu
English: ‘Oral solutions
Slovenian: „Peroralne raztopine
English: A positive opinion was therefore adopted on 20 January 2005.
Slovenian: Tako je bilo pozitivno mnenje sprejeto 20. januarja 2005.
English: The arbitration procedure started on 16 September 2004.
Slovenian: Postopek obravnave se je začel 16. septembra 2004.
English: London, 10 May 2005 EMEA/CHMP/94618/2005
Slovenian: London, 10-05-2005 EMEA/CHMP/94618/2005
English: The final opinion was converted into a Decision by the European Commission on 10 May 2005.
Slovenian: Končno mnenje je bilo dne 10-05-2005 spremenjeno v Odločbo Evropske komisije.
English: During its January 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that a marketing authorisation should be granted.
Slovenian: Na svojem zasedanju januarja 2005 je CHMP glede na celotne predložene podatke in znanstveno razpravo znotraj Odbora menil, da se dovoljenje za promet z zdravilom lahko podeli.
English: The application for Mutual Recognition for Rigevidon was submitted to Denmark and the Mutual Recognition Procedure started on 30 April 2004.
Slovenian: Danska je zatem prejela vlogo za medsebojno priznavanje Rigevidona in 30. aprila 2004 se je začel postopek za medsebojno priznavanje.
English: Rigevidon is a combined oral contraceptive (COC) containing 150µg levonorgestrel (LNG) and 30µg ethinylestradiol (EE2).
Slovenian: Rigevidon je kombinirano peroralno kontracepcijsko sredstvo (COC), ki vsebuje 150µg levonorgestrela (LNG) in 30µg etinilestradiola (EE2).
English: The referral procedure was triggered by the Netherlands, in relation to the acceptance criteria, in bioequivalence studies, of pharmacokinetics parameters, which may need to be tightened, if Rigevidon could be considered as a medicinal product with a narrow therapeutic range.
Slovenian: Nizozemska je sprožila napotitveni postopek v zvezi z merili za sprejemljivost farmakokinetičnih parameterov v študijah bioekvivalence, ki jih je potrebno strožje opredeliti, da se lahko Rigevidon prizna kot zdravilo z ozkim terapevtskim razponom.
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the Summary of Product Characteristics in the Annex III.
Slovenian: Seznam zadevnih imen proizvodov je naveden v Prilogi I. Znanstveni zaključki so podani v Prilogi II,
English: A Marketing Authorisation for Rigevidon was granted to Medimpex France SA by Denmark on 10
Slovenian: Danska je 10. marca 2003 družbi Medimpex France SA za Rigevidon podelila dovoljenje za promet z zdravilom.
English: International Non-Proprietary Name (INN): levonorgestrel and ethinylestradiol
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2) Rigevidon Mednarodno nelastniško ime (INN): levonorgestrel in etinilestradiol
English: Outcome of a procedure under Article 13(2) of Regulation (EC) 1234/2008
Slovenian: Izid postopka v skladu s členom 13(2) Uredbe (ES) 1234/2008
English: The Committee looked at the study presented by the company to support its application.
Slovenian: Odbor je pregledal študijo, ki jo je družba predložila v podporo vlogi.
English: The company that markets these medicines is Mundipharma GmbH.
Slovenian: Ta zdravila trži farmacevtska družba Mundipharma GmbH.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 December 2014 EMA/300/2015
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22.
English: However, the Member States were unable to reach agreement on whether to accept this new indication and on 2 May 2014, Germany referred the matter to the CHMP for arbitration.
Slovenian: Vendar države članice niso uspele doseči soglasja glede odobritve te nove indikacije, zato je Nemčija 2. maja 2014 zadevo napotila v arbitražo odboru CHMP.
English: The European Commission issued an EU-wide legally binding decision to implement this change on 22 December 2014.
Slovenian: Evropska komisija je 22. decembra 2014 izdala pravno zavezujoči sklep o izvajanju navedene spremembe, ki velja za celotno EU.
English: On 23 October 2014, the European Medicines Agency completed an arbitration procedure for Oxynal, Targin and associated names.
Slovenian: Evropska agencija za zdravila je 23. oktobra 2014 končala postopek arbitraže za zdravila Oxynal, Targin in povezana imena.
English: Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Slovenian: Sindrom nemirnih nog je motnja, pri kateri ima bolnik nenadzorovano potrebo po premikanju udov, s katerim poskuša preprečiti neudobne, boleče ali čudne občutke v telesu, navadno ponoči.
English: Oxynal, Targin and associated names are marketed in all EU Member States except Croatia, Greece, Lithuania and Malta.
Slovenian: Zdravila Oxynal, Targin in povezana imena se tržijo v vseh državah članicah EU, razen na Hrvaškem, v Grčiji, Litvi in na Malti.
English: Regarding the safety, the CHMP concluded that overall the risk of tolerance and misuse is considered low and that the proposed measures to reduce this risk are appropriate.
Slovenian: Glede varnosti je odbor CHMP menil, da je splošno tveganje za toleranco in zlorabo majhno ter da so predlagani ukrepi za zmanjšanje tega tveganja ustrezni.
English: Oxynal and Targin have been authorised in the EU under a mutual recognition procedure based on an initial authorisation granted by Germany.
Slovenian: Zdravili Oxynal in Targin sta v EU odobreni s postopkom medsebojnega priznavanja na podlagi prvotnega dovoljenja, ki ga je odobrila Nemčija.