FrancophonIA/ELRC3.0 huggingface dataset:
English: In vivo bioequivalence studies may be exempted if an assumption of equivalence in in vivo performance can be justified by satisfactory in vitro data.
Slovenian: Študije biološke enakovrednosti in vivo je mogoče izvzeti, če je domnevo enakovrednosti pri delovanju in vivo mogoče zadostno utemeljiti s podatki in vitro.
English: Literature data available on the various routes of administration for the same treatment show that dexamethasone is equally effective via any administration route.
Slovenian: Podatki iz literature, ki so na voljo za različne poti uporabe pri istem zdravljenju, kažejo, da je deksametazon pri vseh poteh uporabe enako učinkovit.
English: The BCS-based biowaiver approach is meant to reduce in vivo bioequivalence studies.
Slovenian: Pristop bio-opustitve na podlagi biofarmacevtskega sistema klasifikacije je namenjen zmanjšanju študij biološke enakovrednosti in vivo.
English: In addition, the limited number of published studies that used a solution formulation used a similar posology to the tablet formulation.
Slovenian: Poleg tega je bilo v omejenem številu objavljenih študij, v katerih so uporabili formulacijo v obliki raztopine, odmerjanje podobno kot pri formulaciji v obliki tablet.
English: The objecting Concerned Member State raised a potential serious risk to public health as it considered that the literature data on dexamethasone tablets that had been submitted could not be extrapolated to dexamethasone oral solution without adequate bridging data and therefore the efficacy and safety of Dexamethasone Alapis could not be demonstrated in the application.
Slovenian: Ugovarjajoča zadevna država članica je izpostavila morebitna resna tveganja za javno zdravje, saj je menila, da predloženih podatkov iz literature o tabletah deksametazona ni mogoče prenesti na peroralno raztopino deksametazona brez ustreznih premostitvenih podatkov ter da zato učinkovitosti in varnosti zdravila Dexamethasone Alapis v vlogi ni mogoče dokazati.
English: The CHMP therefore agreed that the bibliographic data provided in support of the application demonstrates the well-established use of dexamethasone sodium phosphate used in the oral solution and that a bioequivalence study was not necessary to show the relevance of the literature used in support of the pharmaceutical form concerned.
Slovenian: CHMP se je zato strinjal, da bibliografski podatki, predloženi v podporo vlogi, dokazujejo dobro uveljavljeno uporabo deksametazon natrijevega fosfata, uporabljenega v peroralni raztopini, in da študija biološke enakovrednosti ni nujno potrebna za dokaz ustreznosti literature, uporabljene v podporo zadevni farmacevtski obliki.
English: Most of the literature provided by the Applicant concerned the administration of an oral solid dosage form, i.e. tablet.
Slovenian: Večina literature, ki jo je predložil predlagatelj, je obravnavala dajanje trdne peroralne oblike odmerjanja, tj. tablete.
English: Because it has only minimal mineral corticoid properties, the drug is inadequate as a monotherapy for the management of adrenocortical insufficiency.
Slovenian: Zdravilo ima le minimalne lastnosti mineralnih kortikoidov, zato ni primerno za samostojno zdravljenje pri adrenokortikalni insuficienci.
English: Dexamethasone is a highly potent and long-acting glucocorticoid with negligible sodium retaining properties.
Slovenian: Deksametazon je zelo močan in dolgo delujoči glukokortikoid, ki v zanemarljivi količini zadržuje natrij.
English: According to the Appendix II of the “Guideline on the investigation of bioequivalence (CPMP/PWP/EWP/1401/98 Rev 1/Corr)”, applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption and considered not to have a narrow therapeutic index.
Slovenian: V skladu z Dodatkom II „Smernic o raziskavah biološke enakovrednosti (CPMP/PWP/EWP/1401/98 Rev 1/Corr)“ je za bio-opustitev na podlagi biofarmacevtskega sistema klasifikacije mogoče zaprositi le pri visoko topnih zdravilnih učinkovinah, ki imajo znano absorpcijo pri ljudeh in nimajo ozkega terapevtskega indeksa.
English: From the literature data provided by the Applicant, it was shown that there were no significant differences between the bioavailabilities of immediate release tablet formulations and elixir formulations of dexamethasone (irrespective of the elixir formulation used).
Slovenian: Iz podatkov iz literature, ki jih je predložil predlagatelj, je bilo razvidno, da ni pomembnih razlik med biološko razpoložljivostjo formulacij v obliki tablet s takojšnjim sproščanjem in formulacij deksametazona v obliki eliksirja (ne glede na vrsto uporabljene formulacije v obliki eliksirja).
English: However, as information on the composition of the dexamethasone syrup, elixir or oral solution investigated in the provided studies was missing in all articles, some concerns were raised on whether those data could be considered as sufficient to allow bridging of the data between the tablets and the oral formulation applied for.
Slovenian: Vendar v nobenem članku ni bilo informacij o sestavi sirupa, eliksirja ali peroralne raztopine deksametazona, ki so jih preučevali v predloženih študijah, poleg tega so bili izraženi nekateri pomisleki, ali so ti podatki zadostni, da omogočajo premostitev podatkov med tabletami in peroralno formulacijo, za katero je bila predložena vloga.
English: Data on the solubility and on the absorption and permeability of dexamethasone were provided by the Applicant during the decentralised and the CMD(h) referral procedure to show that Dexamethasone Alapis met all criteria for a BCS-based biowaiver.
Slovenian: Podatke o topnosti ter absorpciji in propustnosti deksametazona je predlagatelj predložil med decentraliziranim postopkom in napotitvenim postopkom na CMD(h), da bi dokazal, da zdravilo Dexamethasone Alapis izpolnjuje vse pogoje za bio-opustitev na podlagi biofarmacevtskega sistema klasifikacije.
English: The majority of data submitted supporting efficacy and safety with dexamethasone in the indications being sought have been obtained with tablet formulations.
Slovenian: Večina podatkov, predloženih v podporo učinkovitosti in varnosti deksametazona pri indikacijah, za katere je bila predložena vloga, je bila pridobljena s formulacijami v obliki tablet.
English: A referral was thus triggered at the CMD(h) and the Applicant was asked to provide detailed literature and critical assessment of the efficacy and safety of dexamethasone oral solution in the indications applied for.
Slovenian: Pri CMD(h) je bil zato sprožen napotitveni postopek, predlagatelj pa je bil pozvan k predložitvi natančne literature ter kritične ocene učinkovitosti in varnosti peroralne raztopine deksametazona pri indikacijah, za katere je bila predložena vloga.
English: Although the “Guideline on the investigation of bioequivalence (CPMP/PWP/EWP/1401/98 Rev 1/Corr)” states: “In those cases where the test product is an oral solution which is intended to be bioequivalent to another immediate release oral dosage form, bioequivalence studies are required”, the application of a BCS-based biowaiver to bridge data from different pharmaceutical forms was considered to have been adequately justified from a scientific point of view, by provision of parallel artificial membrane permeability assay (PAMPA) data, literature and dissolution data, demonstrating that Dexamethasone drug substance has biopharmaceutical characteristics of BCS Class I/III, and that the excipients have no adverse affects on bioavailability.
Slovenian: Čeprav je v „Smernicah o raziskavah biološke enakovrednosti (CPMP/PWP/EWP/1401/98 Rev 1/Corr)“ navedeno: „Kadar je preskušano zdravilo peroralna raztopina, ki naj bi se uporabljala kot biološko enakovredno zdravilo drugemu zdravilu s peroralnim načinom odmerjanja s takojšnjim sproščanjem, so potrebne študije biološke enakovrednosti“, je veljalo, da je bilo izvajanje bio opustitve na podlagi biofarmacevtskega sistema klasifikacije za premostitev podatkov iz različnihfarmacevtskih oblik znanstveno zadostno utemeljeno s predložitvijo vzporednih podatkov o testiranju prepustnosti umetne membrane, literature in podatkov o raztapljanju, s čimer je bilo dokazano, da ima zdravilna učinkovina deksametazon biofarmacevtske značilnosti razreda I/III iz biofarmacevtskega sistema klasifikacije ter da pomožne snovi nimajo neželenih učinkov na biološko razpoložljivost.
English: The bibliography provided was considered sufficient to support the well established use of dexamethasone substance in different tablet formulations.
Slovenian: Predloženi bibliografski podatki so zadoščali za podporo dobro uveljavljeni uporabi deksametazona v različnih formulacijah v obliki tablet.
English: It was therefore concluded by the CHMP that efficacy and safety of dexamethasone active substance in the therapeutic indications applied for had been sufficiently demonstrated by the provided literature.
Slovenian: CHMP je zato zaključil, da sta učinkovitost in varnost zdravilne učinkovine deksametazon pri terapevtskih indikacijah, za katere je bila predložena vloga, zadostno dokazani s predloženo literaturo.
English: In order to extrapolate efficacy and safety data from these studies to the oral solution formulation applied for, the Applicant provided data that showed that irrespective of immediate release oral dosage formulation (tablet or solution), the bioavailability of dexamethasone in terms of extent and rate of absorption, was similar.
Slovenian: Da bi bilo mogoče podatke o učinkovitosti in varnosti iz teh študij prenesti na formulacijo v obliki peroralne raztopine, za katero je bila predložena vloga, je predlagatelj predložil podatke, iz katerih je razvidno, da je pri formulacijah s peroralno obliko odmerjanja s takojšnjim sproščanjem (tableta ali raztopina) biološka razpoložljivost deksametazona glede obsega in hitrosti absorpcije podobna.
English: As a justification for not providing bioequivalence study to bridge the data submitted on the tablet formulation and the oral solution formulation applied for, the Applicant applied for a BCS (Biopharmaceutics Classification System)-based biowaiver.
Slovenian: Kot utemeljitev, zakaj ni bila predložena študija biološke enakovrednosti za premostitev predloženih podatkov o formulaciji v obliki tablet in formulaciji v obliki peroralne raztopine, za katero je bila predložena vloga, je predlagatelj zaprosil za bio-opustitev na podlagi biofarmacevtskega sistema klasifikacije.
English: In addition, a few literature reports (CTs) on the efficacy and safety of dexamethasone in oral solution/syrup have been submitted in the following indications applied for:
Slovenian: Poleg tega je bilo za naslednje indikacije, za katere je bila predložena vloga, predloženih nekaj poročil iz literature (CT) o učinkovitosti in varnosti deksametazona v obliki peroralne raztopine/sirupa:
English: Therefore, a huge volume of efficacy and safety data exists for the dexamethasone pharmaceutical substance.
Slovenian: Za farmacevtsko učinkovino deksametazon torej obstaja veliko podatkov o učinkovitosti in varnosti.
English: Additional bridging data (or its absence fully justified) between the bibliographic data and the proposed pharmaceutical product were therefore requested to the Applicant during the decentralised and the CMD(h) referral procedures.
Slovenian: Med decentraliziranim postopkom in napotitvenim postopkom na CMD(h) so se zato od predlagatelja zahtevali dodatni premostitveni podatki (ali podrobna utemeljitev njihove odsotnosti) med bibliografskimi podatki in predlaganim zdravilom.
English: Whereas, - the Applicant has provided sufficient literature data to demonstrate well-established use of dexamethasone, - efficacy and safety of dexamethasone has been adequately shown in the indications applied for - adequate bridging data between the tablet formulation and the oral solution formulation have been provided by the Applicant, the CHMP has recommended the granting of the marketing authorisation(s) 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: CHMP je priporočil odobritev dovoljenj za promet z zdravilom, katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki zadnjim različicam, pripravljenim v postopku usklajevalne skupine in navedenim v Prilogi III tega mnenja.
English: The National Competent Authorities of Member States, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Slovenian: Nacionalni pristojni organi držav članic, ki jih usklajuje referenčna država članica, bodo zagotovili, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
English: Conditions for lifting the suspension of the Marketing Authorisations
Slovenian: Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
English: Annex III Conditions for lifting the suspension of the Marketing Authorisations
Slovenian: Priloga III Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom
English: This difference was considered to be too small to be relevant.
Slovenian: Ta razlika je bila premajhna, da bi bila pomembna.
English: International non-proprietary name (INN): ramelteon
Slovenian: Mednarodno nelastniško ime (INN): ramelteon
English: All of the studies but one were short-term, lasting five weeks or less.
Slovenian: Vse študije, razen ene, so bile kratke, saj so trajale pet tednov ali manj.
English: Ref. EMEA/CHMP/502946/2008
Slovenian: EMEA/549016/2008
English: ‘Primary' means that the insomnia does not have any identified cause, including other medical, mental or environmental causes.
Slovenian: „Primarna“ pomeni, da za nespečnost ni znanih vzrokov, na primer drugih zdravstvenih, duševnih ali okoljskih vzrokov.
English: Most of the studies were carried out in sleep laboratories, but the three main studies were carried out in the ‘natural setting' (at home) in a total of 2,807 patients.
Slovenian: Večina študij je potekala v spalnih laboratorijih, tri glavne študije pa so potekale v naravnem okolju (doma) s skupaj 2 807 bolniki.
English: It was to be available as tablets.
Slovenian: Naj voljo naj bi bilo v tabletah.
English: The company had requested a re-examination of the negative opinion, but this had not yet finished when the company withdrew.
Slovenian: Družba je zahtevala ponovno proučitev negativnega mnenja, ki pa še ni bila zaključena, ko se je odločila za umik svoje vloge.
English: The one long-term study lasted six months, during which patients spent some nights in a sleep laboratory.
Slovenian: Dolga študija je trajala šest mesecev, med njo pa so bolniki preživeli nekaj noči v spalnem laboratoriju.
English: The effects of Ramelteon were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Ramelteon so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The main measure of effectiveness was the time taken for the patients to fall asleep.
Slovenian: Glavno merilo učinkovitosti je bil čas, potreben, da je bolnik zaspal.
English: Ramelteon was expected to be used to treat primary insomnia (difficulty falling and staying asleep, and poor quality of sleep) in patients aged 18 years or over.
Slovenian: Zdravilo Ramelteon naj bi se uporabljalo za zdravljenje primarne nespečnosti (težave z uspavanjem in zbujanje ter slaba kakovost spanca) pri bolnikih starih 18 let in več.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Ramelteon?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Ramelteon?
English: On 19 September 2008, Takeda Global Research & Development Centre (Europe) Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramelteon, for the treatment of primary insomnia in adult patients.
Slovenian: Družba Takeda Global Research & Development Centre (Europe) Ltd je dne 19. septembra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Ramelteon, namenjenim zdravljenju primarne nespečnosti pri odraslih bolnikih.
English: The Committee was also concerned that the company had not demonstrated the long-term effectiveness of Ramelteon.
Slovenian: Odbor je imel pomisleke tudi zato, ker družba ni dokazala dolgotrajne učinkovitosti zdravila Ramelteon.
English: The effectiveness of Ramelteon was compared with that of placebo (a dummy treatment) in a total of about 5,400 patients.
Slovenian: Učinkovitost zdravila Ramelteon so primerjali z učinkovitostjo placeba (zdravila brez zdravilne učinkovine) pri skupaj približno 5 400 bolnikih.
English: Questions and answers on the withdrawal of the marketing application for Ramelteon
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Ramelteon
English: Ramelteon was expected to work in the same way as melatonin in promoting sleep.
Slovenian: Zdravilo Ramelteon naj bi na enak način kot melatonin delovalo pri spodbujanju spanca.
English: only one of the three studies carried out in the natural setting was there a difference in the time taken to fall asleep between patients taking Ramelteon and those taking placebo.
Slovenian: Poleg tega je bila med študijami, ki so potekale doma, samo pri eni opažena razlika v času, potrebnem, da je bolnik zaspal, tj. med bolniki, ki so jemali Ramelteon in tistimi, ki so jemali placebo.
English: When other aspects of sleep were considered, Ramelteon did not have any effect.
Slovenian: Pri proučevanju drugih vidikov spanja zdravilo ni imelo Ramelteon nobenega učinka.
English: The CHMP was concerned that the company had not demonstrated the effectiveness of Ramelteon, which was measured by looking at only one aspect of insomnia, the time to fall asleep.
Slovenian: CHMP je imel pomisleke, da družba ni zadovoljivo dokazala učinkovitosti zdravila Ramelteon, ki je bila merjena z opazovanjem enega samega vidika nespečnosti, tj. časa, potrebnega, da je bolnik zaspal.
English: The active substance in Ramelteon, ramelteon, is a melatonin-receptor agonist.
Slovenian: Zdravilna učinkovina v zdravilu Ramelteon, ramelteon, je agonist receptorja melatonina.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Ramelteon for the treatment of primary insomnia in adult patients.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je odbor izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet za zdravilo Ramelteon, namenjenim zdravljenju primarne nespečnosti pri odraslih bolnikih.
English: This means that it works by attaching itself to the receptors that melatonin normally attaches to. Melatonin is a naturally occurring hormone that is involved in co-ordinating the body's sleep cycle by acting on receptors in specific areas of the brain.
Slovenian: Melatonin je naravno prisoten hormon, ki sodeluje pri usklajevanju spalnega cikla telesa tako, da učinkuje na receptorje v določenih predelih možganov.
English: Ramelteon is a medicine that contains the active substance ramelteon.
Slovenian: Ramelteon je zdravilo, ki vsebuje zdravilno učinkovino ramelteon.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programs with Ramelteon in the European Union.
Slovenian: Družba je CHMP obvestila, da v Evropski uniji ne potekajo nobena klinična preskušanja ali programi sočasne uporabe zdravila Ramelteon.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Ramelteon had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: V času umika je zato CHMP menil, da koristi zdravila Ramelteon niso zadostno dokazane in da ne odtehtajo znanih tveganj.
English: What is Ramelteon?
Slovenian: Kaj je zdravilo Ramelteon?
English: What was Ramelteon expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Ramelteon uporabljalo?
English: How is Ramelteon expected to work?
Slovenian: Kako naj bi zdravilo Ramelteon delovalo?
English: This procedure usually takes 3-4 hours.
Slovenian: Ta postopek običajno traja 3-4 ure.
English: In the insulated container 18 hours.
Slovenian: V izoliranem vsebniku 18 ur.
English: This may be due to a number of reasons, for example, if there is:
Slovenian: Vzrokov je lahko več, na primer:
English: Some have resulted in hospitalization.
Slovenian: Nekatere so povzročile hospitalizacijo.
English: It should not be given to children or adolescents under the age of 18 years.
Slovenian: Ni ga dovoljeno dajati otrokom ali mladostnikom, starim manj kot 18 let.
English: If this happens, do not drive or use any tools or machines until you feel better.
Slovenian: Če se to zgodi, ne vozite in ne upravljajte orodij ali strojev, dokler se ne počutite bolje.
English: • Additional risk minimisation measures
Slovenian: • Dodatni ukrepi za zmanjšanje tveganja
English: Educational material for Healthcare professionals 3.
Slovenian: Izobraževalno gradivo za zdravstvene strokovnjake 3.
English: A small number of these patients discontinued treatment as a result.
Slovenian: Majhno število teh bolnikov je posledično zdravljenje prekinilo.
English: To provide data from the observational US-based registry (PROCEED, Study P10-3)
Slovenian: Da predloži podatke iz seznama opazovanj v ZDA (PROCEED, študija P10-3)
English: It is very important that you arrive on time for your appointments.
Slovenian: Zelo pomembno je, da pravočasno pridete na vsak dogovorjen obisk.
English: Microbiological testing
Slovenian: Mikrobiološko testiranje
English: Abbreviations: CI = confidence interval.
Slovenian: Okrajšave: IZ = interval zaupanja
English: c p-value based on a log-rank test.
Slovenian: c vrednost p na podlagi testa log-rank.
English: Patients should be advised of this possibility prior to initiating treatment.
Slovenian: Bolnike je treba na to možnost pred začetkom zdravljenja opozoriti.
English: Overall survival was not a study endpoint but a pre-specified analysis.
Slovenian: Celokupno preživetje ni bil opazovani dogodek v študiji, temveč predhodno specificirana analiza.
English: These patients should be closely monitored for signs and symptoms of infection.
Slovenian: Te bolnike je treba skrbno spremljati za znake in simptome okužbe.
English: Once the infusion is complete you will be observed and monitored for at least 30-60 minutes, after which, you may go home.
Slovenian: Po končanem infundiranju vas bodo vsaj 30-60 minut opazovali in spremljali, nato pa lahko greste domov.
English: Submission of study protocol with first PSUR
Slovenian: Protokol študije predložiti s prvim PSUR
English: You may also be given other medicines if needed.
Slovenian: Po potrebi boste prejeli druga zdravila.
English: * Primarily associated with the leukapheresis procedure
Slovenian: * Primarno povezana s postopkom levkafereze
English: Table 2 Summary of overall survival (all patients as randomized) IMPACT
Slovenian: Preglednica 2 Povzetek celokupnega preživetja (vsi bolniki kot randomizirani) IMPACT
English: Your doctor or nurse will confirm that your details (name and date of birth) correspond to the details provided with the Provenge container.
Slovenian: Vaš zdravnik ali medicinska sestra bosta potrdila, da se vaši podatki (ime in datum rojstva) ujemajo s podrobnostmi na vsebniku z zdravilom Provenge.
English: NL-6229 EV, Maastricht The Netherlands
Slovenian: NL-6229 EV, Maastricht Nizozemska
English: A cell filter should not be used.
Slovenian: Celičnega filtra se ne sme uporabiti.
English: The physician should monitor and/or treat the patient as appropriate.
Slovenian: Zdravnik mora bolnika spremljati in/ali zdraviti, kot je ustrezno.