FrancophonIA/ELRC3.0 huggingface dataset:
English: In a second main study involving 1,417 patients, patients were given Tecfidera, placebo or another medicine, glatiramer acetate.
Slovenian: V drugi glavni študiji, v kateri je sodelovalo 1 417 bolnikov, so bolnikom dajali zdravilo Tecfidera, placebo ali drugo zdravilo, imenovano glatiramer acetat.
English: A risk management plan has been developed to ensure that Tecfidera is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Tecfidera je bil pripravljen načrt obvladovanja tveganj.
English: It is not intended to provide practical advice on how to use Tecfidera.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The active substance, dimethyl fumarate, is thought to work by activating a protein called ‘Nrf2' that regulates certain ‘antioxidant' genes involved in protecting cells from damage.
Slovenian: Zdravilna učinkovina, dimetilfumarat, naj bi delovala tako, da aktivira beljakovino, imenovano „Nrf2“, ki uravnava določene „antioksidativne“ gene, ki pomagajo ščititi celice pred poškodbami.
English: It is used to treat multiple sclerosis (MS), a disease in which inflammation destroys the protective sheath around the nerves.
Slovenian: Uporablja se za zdravljenje multiple skleroze (MS), tj. bolezni, pri kateri vnetje uniči zaščitno ovojnico okoli živcev.
English: The main risks identified with Tecfidera are considered to be manageable and include flushing and gastrointestinal problems (the most common side effects), as well as reduced levels of white blood cells and protein in the urine.
Slovenian: Glavna ugotovljena tveganja, povezana z zdravilom Tecfidera, so bila ocenjena kot obvladljiva ter vključujejo vročinske oblive in težave s prebavili (najpogostejši neželeni učinki) ter znižanje ravni belih krvnih celic in beljakovin v urinu.
English: What is Tecfidera and what is it used for?
Slovenian: Kaj je zdravilo Tecfidera in za kaj se uporablja?
English: In MS, the body's immune system malfunctions and attacks parts of the central nervous system (the brain and spinal cord), causing the inflammation that damages the nerve sheaths.
Slovenian: Pri multipli sklerozi imunski sistem telesa ne deluje pravilno in napade dele osrednjega živčevja (možgane in hrbtenjačo), s čimer povzroči vnetje, ki poškoduje ovojnico okoli živcev.
English: What are the risks associated with Tecfidera?
Slovenian: Kakšna tveganja so povezana z zdravilom Tecfidera?
English: What benefits of Tecfidera have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Tecfidera izkazalo v študijah?
English: Why is Tecfidera approved?
Slovenian: Zakaj je bilo zdravilo Tecfidera odobreno?
English: For more information about treatment with Tecfidera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Tecfidera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with Tecfidera (which may affect more than 1 in 10 people) are flushing (reddening of skin) and gastrointestinal problems (such as diarrhoea, nausea, and pain in the abdominal area).
Slovenian: Najpogostejši neželeni učinki zdravila Tecfidera (ki lahko prizadenejo več kot 1 osebo od 10) so vročinski oblivi (rdečina kože) in težave s prebavili (na primer driska, slabost in bolečine v predelu trebuha).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tecfidera, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Tecfidera in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: In a main study involving 1,234 patients, the proportion of patients who experienced a relapse over the course of two years was significantly lower with Tecfidera treatment than with placebo (a dummy treatment): 27% versus 46%.
Slovenian: V glavni študiji, v kateri je sodelovalo 1 234 bolnikov, je bil delež bolnikov, ki so v obdobju dveh let imeli recidiv, znatno manjši pri zdravljenju z zdravilom Tecfidera kot pri zdravljenju s placebom (zdravilom brez zdravilne učinkovine): 27 % v primerjavi s 46 %.
English: This study showed Tecfidera to be more effective than placebo in reducing the number of relapses over the course of two years: the number of relapses per patient per year was around 0.2 with Tecfidera compared with 0.4 with placebo.
Slovenian: Ta študija je pokazala, da je zdravilo Tecfidera učinkovitejše od placeba pri zmanjšanju števila recidivov v obdobju dveh let: število recidivov na bolnika na leto je bilo približno 0,2 pri zdravljenju z zdravilom Tecfidera in 0,4 pri zdravljenju s placebom.
English: For practical information about using Tecfidera, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Tecfidera naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The number of relapses per patient per year for glatiramer acetate was 0.3.
Slovenian: Pri zdravljenju z glatiramer acetatom je bilo število recidivov na bolnika na leto 0,3.
English: Tecfidera can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating MS.
Slovenian: Izdaja zdravila Tecfidera je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem multiple skleroze.
English: For the full list of all side effects reported with Tecfidera, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tecfidera, glejte navodilo za uporabo.
English: Dimethyl fumarate, has been shown in studies to reduce the inflammation and modulate the activity of the immune system.
Slovenian: Študije so pokazale, da dimetilfumarat zmanjša vnetje in uravnava delovanje imunskega sistema.
English: Tecfidera has been shown to be effective in reducing the number of relapses in patients with relapsingremitting MS and in reducing the number of patients who have relapses during treatment.
Slovenian: Zdravilo Tecfidera se je izkazalo za učinkovito pri zmanjšanju števila recidivov pri bolnikih z recidivno remitentno multiplo sklerozo in pri zmanjšanju števila bolnikov, pri katerih se med zdravljenjem pojavijo recidivi.
English: It is used specifically in adults with a type of MS known as relapsing-remitting MS, where the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Slovenian: Zdravilo Tecfidera se uporablja samo pri odraslih z vrsto multiple skleroze, imenovano recidivno remitentna multipla skleroza, pri kateri ima bolnik napade (recidive) simptomov, ki jim sledijo obdobja izboljšanja (remisije).
English: How does Tecfidera work?
Slovenian: Kako zdravilo Tecfidera deluje?
English: How is Tecfidera used?
Slovenian: Kako se zdravilo Tecfidera uporablja?
English: Tecfidera has been shown to reduce the number of relapses in patients with relapsing-remitting MS and to reduce the number of patients who have them.
Slovenian: Študije so pokazale, da zdravilo Tecfidera zmanjša število recidivov pri bolnikih z recidivno remitentno multiplo sklerozo in zmanjša število bolnikov, ki imajo recidive.
English: The dose may be reduced temporarily in patients experiencing side effects of flushing and gastrointestinal problems.
Slovenian: Pri bolnikih, pri katerih se kot neželeni učinki pojavijo vročinski oblivi in težave s prebavili, se lahko odmerek začasno zmanjša.
English: Those data can be summarised as follows:
Slovenian: Podatke je mogoče povzeti takole:
English: The conclusions of the study are accepted.
Slovenian: Zaključki študije se sprejmejo.
English: The application was submitted to Ireland as reference Member State and Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain and the United Kingdom as concerned Member States.
Slovenian: Vloga je bila predložena Irski kot referenčni državi članici ter Belgiji, Danski, Franciji, Nemčiji, Grčiji, Italiji, Luksemburgu, Nizozemski, Portugalski, Španiji in Veliki Britaniji kot zadevnim državam članicam.
English: The study was conducted at multiple sites in Germany and Spain.
Slovenian: Študija je potekala na več krajih v Nemčiji in Španiji.
English: Therefore, its use as the positive control is in line with existing guidance and is considered legitimate.
Slovenian: Zato je njegova uporaba kot pozitivna kontrola v skladu z obstoječimi smernicami in legitimna.
English: Elimination half-life was estimated to be 13.76 + 6.42 hours.
Slovenian: Ocenjeni razpolovni čas izločanja je bil 13,76 + 6,42 ure.
English: The concerns raised by Denmark remained unsolved and consequently the matter was referred to the CVMP on 21 September 2011.
Slovenian: Tisti pa, ki jih je izrazila Danska, so ostale nerešeni, zato je bila zadeva 21. septembra 2011 napotena na odbor CVMP.
English: During the decentralised procedure two concerned Member States identified potential serious risks regarding the proposed indications (France) and the efficacy of the product (Denmark).
Slovenian: Med decentraliziranim postopkom sta dve zadevni državi članici opredelili možna resna tveganja v zvezi s predlaganimi indikacijami (Francija) in učinkovitostjo zdravila (Danska).
English: The isolates on which the MIC data are based were collected from sheep with respiratory tract disease between 2006 and 2010.
Slovenian: Izolati, na katerih temeljijo podatki MIK, so bili pridobljeni pri ovcah z boleznijo dihalnih poti med letoma 2006 in 2010.
English: This part of the dossier was not assessed in this referral procedure as no concern was notified by the reference Member State nor was any concern raised during the procedure as the dose remains as proposed and concluded by the reference Member State.
Slovenian: Ta del dokumentacije v tem napotitvenem postopku ni bil ocenjen, ker referenčna država članica ni sporočila nobenih skrbi in ker se med postopkom niso pojavile nobene nove skrbi, saj ostaja odmerek enak predlaganemu, o katerem je odločila referenčna država članica.
English: The warnings in the product literature remain appropriate with the change indicated in section 2.4 below.
Slovenian: Opozorila v literaturi o zdravilu so ustrezna, razen spremembe v poglavju 2.4, ki je navedena spodaj.
English: During the procedure the applicant provided additional data and the issues raised by France regarding the proposed indications were resolved.
Slovenian: Med tem postopkom je predlagatelj predložil dodatne podatke in pomisleki, ki jih je izpostavila Francija glede predlaganih indikacij, so bili rešeni.
English: The adequacy of the treatment interval was one of the main points of discussion during the referral procedure.
Slovenian: V napotitvenem postopku je bila ustreznost intervalov zdravljenja ena od glavnih točk razprave.
English: No further risk management or mitigation measures are required as a consequence of this referral procedure.
Slovenian: Nadaljnja obvladovanja tveganj ali ukrepi za njihovo zmanjšanje kot posledica tega napotitvenega postopka niso potrebni.
English: • A variety of studies are available on the distribution of florfenicol in bronchial secretions in man and various animal species (pigs and calves).
Slovenian: • Na voljo so različne študije o porazdelitvi florfenikola v izločkih bronhijev pri ljudeh in različnih živalskih vrstah (prašiči in teleta).
English: Furthermore, the treatment failure rates in the clinical field study submitted by the applicant were considered too high.
Slovenian: Nadalje je menila, da je delež neuspešnega zdravljenja v klinični terenski študiji, ki jo je predložil predlagatelj, previsok.
English: Risk management or mitigation measures
Slovenian: Obvladovanje tveganj ali ukrepi za njihovo zmanjšanje
English: The valid Summary of Product Characteristics, Labelling and Package Leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Slovenian: Veljaven povzetek glavnih značilnosti zdravila, označevanja in navodil za uporabo je končna verzija, ki je bila sprejeta v teku postopka koordinacijske skupine z naslednjimi dopolnili:
English: In order to address the concerns raised by the referral, the applicant presented all available efficacy data for sheep.
Slovenian: V odziv na pomisleke, izražene v napotitvi, je predlagatelj predložil vse razpoložljive podatke o učinkovitosti pri ovcah.
English: Field study
Slovenian: Študija na terenu
English: In terms of design, the field study followed EMA/CVMP guideline recommendations.
Slovenian: V zasnovi študije so bila upoštevana priporočila smernic EMA/CVMP.
English: Having considered all data submitted in writing and in the oral explanation the CVMP concluded that:
Slovenian: Ob upoštevanju vseh pisno predloženih podatkov in ustnih razlag je odbor CVMP sklenil:
English: The concern relating to the high failure rate and assumed lack of efficacy has been addressed under benefit assessment.
Slovenian: Skrbi, povezane z visoko stopnjo neučinkovitosti zdravljenja in domnevno neučinkovitostjo, so bile obravnavane v okviru ocene koristi.
English: The applicant provided detailed pharmacodynamic and pharmacokinetic data to justify the proposed dose for the claimed indication.
Slovenian: Predlagatelj je predložil podrobne farmakodinamične in farmakokinetične podatke, v katerih utemeljuje predlagani odmerek za navedeno indikacijo.
English: Based on the data presented in relation to the concerns notified for this referral procedure, the Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefit-risk balance was favourable.
Slovenian: Na podlagi podatkov, predloženih v zvezi s pomisleki, sporočenimi v tem napotitvenem postopku, je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) zaključil, da je razmerje med tveganji in koristmi za zdravilo pozitivno.
English: Thus, florfenicol behaves essentially like a bactericidal time dependant antibiotic.
Slovenian: Zato se florfenikol v bistvu vede kot antibiotik, odvisen od baktericidnega časa.
English: For the objecting Member State, this gave rise to concerns that there was the potential for underdosing and that there may be an increase in risk for development of florfenicol resistance.
Slovenian: Ugovarjajoča država članica je zaradi tega izrazila skrb, da obstaja možnost za premajhno odmerjanje in posledično povečanje razvoja odpornosti proti florfenikolu.
English: Add the following text in the relevant sections of the product information:
Slovenian: Dodaj naslednje besedilo v ustrezno poglavje o značilnostih zdravila:
English: Based on the available pharmacodynamic data, it is accepted that a dose selected on the basis of this study should also be predictive of likely efficacy against P. multocida.
Slovenian: Na podlagi razpoložljivih podatkov o farmakodinamiki se sprejme, da odmerek, določen na podlagi te študije, napoveduje verjetno učinkovitost proti P. multocida.
English: Repeat administration of 20 mg/kg once daily for three days (proposed posology) resulted in some accumulation (accumulation factor of 1.48).
Slovenian: Ponavljajoče se dajanje 20 mg/kg enkrat dnevno, ki je trajalo tri dni (predlagano odmerjanje), je povzročilo nekaj akumulacije (akumulacijski faktor 1,48).
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, routes of administration, applicant in the Member States
Slovenian: Seznam imen, farmacevtska oblika, jakost zdravila za uporabo v veterinarski medicini, ciljna živalska vrsta, način uporabe , predlagatelj v državi članici
English: Quality, User safety, Environmental risk and Residues were not assessed in this referral procedure.
Slovenian: V tem napotitvenem postopku kakovost, varnost za uporabnika, tveganje za okolje in ostanki zdravila niso bili ocenjeni.
English: (Clinical breakpoint is a MIC value used by clinicians to classify bacteria as susceptible or resistant to a certain antimicrobial and is therefore a measure of clinical efficacy.)
Slovenian: (Klinična mejna vrednost je vrednost MIK, ki jo zdravniki uporabljajo za razvrstitev bakterije med občutljive ali odporne proti določenemu antimikrobnemu zdravilu, zato je merilo klinične učinkovitosti).
English: It is noted that, currently, for ovine respiratory disease pathogens there is no internationally agreed breakpoint for florfenicol sensitivity.
Slovenian: Pri tem se upošteva, da za povzročitelje bolezni dihal pri ovcah trenutno ni mednarodno dogovorjene mejne vrednosti za občutljivost na florfenikol.
English: The concerns raised for this referral procedure related to the efficacy of the product.
Slovenian: Pomisleki, izraženi v tem napotitvenem postopku, se nanašajo na učinkovitost zdravila.
English: While similar data have not been generated for sheep, it is reasonable to assume that that florfenicol concentrations achieved in plasma reflect what will be achieved in the lung.
Slovenian: Čeprav podobnih podatkov za ovce ni, je razumno sklepati, da koncentracije florfenikola, dosežene v plazmi, izražajo koncentracije, ki bi bile dosežene v pljučih.
English: The available data suggest, therefore, that for this antibiotic the most relevant parameter for prediction of efficacy is time above MIC.
Slovenian: Razpoložljivi podatki zato kažejo, da je za ta antibiotik najpomembnejši parameter pri napovedovanju učinkovitosti čas, ko je njegova koncentracija višja od MIK.
English: There appears to be no advantage to increasing the dose to 30 mg/kg.
Slovenian: Kaže, da povečanje odmerka na 30 mg/kg ne prinese dodatnih koristi.
English: The active substance is included in veterinary medicinal products currently licensed in several countries in the European Union for use in cattle and pigs for the treatment of respiratory disease.
Slovenian: Zdravilna učinkovina je vsebovana v zdravilih za uporabo v veterinarski medicini, ki so trenutno odobrena v več državah Evropske unije za uporabo pri govedu in prašičih za zdravljenje bolezni dihal.
English: While there were some reservations about the use of oxytetracycline as the positive control, it is accepted that the chosen comparator product has a claim for ovine respiratory disease and is commonly used as a first-line therapy that will most likely be administered without any information on the sensitivity of causal organisms.
Slovenian: Čeprav obstajajo glede uporabe oksitetraciklina kot pozitivne kontrole nekateri zadržki, se sprejme, da je izbrano primerjano zdravilo odobreno za zdravljenje bolezni dihal pri ovcah in da se pogosto uporablja kot zdravljenje prve izbire, ki se običajno uporabi brez vsakršnih informacij o občutljivosti povzročiteljev.
English: There was a concern that a dose of 20 mg florfenicol/kg administered intramuscularly every 24 hours would not maintain an active/effective concentration of florfenicol at the infection site for the between treatment interval (that is, 24 hours).
Slovenian: Izražen je bil pomislek, da odmerek florfenikola 20 mg/kg, dan intramuskularno vsakih 24 ur, ne ohranja aktivne oziroma učinkovite koncentracije florfenikola na mestu okužbe v intervalu med odmerki (to je 24 ur).
English: The selected dose and between treatment interval was in line with the PK/PD conclusions.
Slovenian: Izbrani odmerek in interval med odmerki sta bila skladna z zaključki o farmakokinetiki/farmakodinamiki.
English: • The MIC90 values of florfenicol are in the range 0.5 - 1 μg/ml for target pathogens M. haemolytica and P. multocida.
Slovenian: • Vrednosti MIK90 za florfenikol so v razponu 0,5-1 μg/ml za ciljna povzročitelja bolezni M. haemolytica in P. multocida.
English: From the M. haemolytica data, it can be seen that time to achieve a 3-Log reduction decreased with increasing florfenicol concentration; and, after only two hours exposure, florfenicol exhibits a post-antibiotic effect (ranging from 1 - 3 hours at concentrations >1 μg/ml).
Slovenian: Iz podatkov za M. haemolytica je mogoče videti, da se je čas do doseženega zmanjšanja 3-log krajšal z naraščanjem koncentracije florfenikola; in po samo dveh urah izpostavljenosti kaže florfenikol poantibiotični učinek (v razponu od 13 ur pri koncentracijah ≥ 1 μg/ml).
English: • Although some concentration dependency trends were observed for M. haemolytica strains, the killing effect/kinetic does not increase dramatically with the concentration of the antibiotic over the MIC or twice the MIC.
Slovenian: • Čeprav so za seve M. haemolytica opazili nekatere trende, odvisne od koncentracije, se učinek uničevanja oziroma kinetika ne poveča dramatično, če so koncentracije antibiotika višje od MIK ali dvakratnik MIK-a.
English: Pharmacokinetics/pharmacodynamics data (PK/PD)
Slovenian: Farmakokinetični/farmakodinamični podatki
English: • The following can be concluded from the pharmacodynamic data presented: florfenicol has a pronounced bactericidal effect with Minimum Bactericidal Concentration (MBC) values the same, or one dilution higher, than the MIC of the tested strains.
Slovenian: • Iz predloženih farmakodinamičnih podatkov je mogoče sklepati naslednje: florfenikol ima izrazit baktericidni učinek z vrednostmi minimalne baktericidne koncentracije (MBK), ki so enake, po razredčitvi pa višje, od MIK testiranih sevov.
English: Based on available data, it would appear that florfenicol concentrations achieved in lung tissue/bronchial secretions are at least as high as those detected in serum.
Slovenian: Iz razpoložljivih podatkov je videti, da so koncentracije florfenikola, dosežene v pljučnem tkivu/izločkih bronhijev, vsaj tako visoke kot tiste, ki so jih izmerili v serumu.
English: Based on dossier data concerning Minimum Inhibitory Concentrations (MICs) for florfenicol (MIC90= 1 µg/ml) and considering its pharmacokinetic/pharmacodynamic (PK/PD) plasma profile, the period of exposure to the MIC90 strength was believed by the objecting Member State to be too short.
Slovenian: Na podlagi podatkov iz dokumentacije v zvezi z minimalnimi inhibitornimi koncentracijami (MIK) za florfenikol (MIK90 = 1 µg/ml) in ob upoštevanju njegovega farmakokinetičnega/farmakodinamičnega profila v plazmi ugovarjajoča država članica meni, da je obdobje izpostavljenosti jakosti MIK90 prekratko.
English: In support of the proposed recommended treatment dose, the applicant conducted a comprehensive dose finding study using an experimental model of respiratory disease where test animals were challenged with M. haemolytica.
Slovenian: V podporo predlaganemu terapevtskemu odmerku je predlagatelj izvedel obsežno študijo za določitev odmerka z uporabo poskusnega modela bolezni dihal, kjer so bile testirane živali okužene z M. haemolytica.
English: The applicant Intervet International BV submitted an application for a decentralised procedure (DCP) for an extension (Article 19 of Regulation (EC) 1234/2008) of the existing marketing authorisation of Nuflor 300 mg/ml solution for injection for cattle to add sheep as a target species.
Slovenian: Predlagatelj, Intervet International BV, je predložil vlogo za decentralizirani postopek (DCP) za podaljšanje (člen 19 Uredbe Komisije (ES) 1234/2008) obstoječega dovoljenja za promet z zdravilom Nuflor 300 mg/ml raztopina za injiciranje za govedo in ovce kot ciljni živalski vrsti.
English: The preclinical data provided support the recommended treatment interval (24 hours) for target pathogens with MIC up to 1 μg/ml.
Slovenian: Predklinični podatki potrjujejo priporočen interval zdravljenja (24 ur) za ciljne bakterije za katere je MIC do 1 μg/ml.
English: The benefit of florfenicol is that ovine respiratory disease associated with susceptible M. haemolytica and P. multocida can effectively be treated.
Slovenian: Korist florfenikola je učinkovito zdravljenje bolezni dihal pri ovcah, ki jih povzročata občutljivi M. haemolytica in P. multocida.
English: Summary of Product Characteristics
Slovenian: Povzetek glavnih značilnosti