FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the retrospective case-control study conducted in Brest in order to look for a link between exposure to benfluorex and the occurrence of unexplained mitral insufficiency, establishes an association between the exposure to benfluorex and the occurrence of valvulopathy.
Slovenian: Poleg tega je retrospektivna študija primerov in kontrol, ki je bila izvedena v Brestu in katere namen je bil ugotavljanje povezave med izpostavljenostjo benfluoreksu in pogostostjo primerov nerazložene mitralne insuficience, ugotovila povezavo med izpostavljenostjo benfluoreksu in pogostostjo primerov valvulopatije.
English: • The Committee concluded, after having reviewed the available data, that benfluorex is harmful under normal conditions of use leading to pulmonary hypertension and cardiac valvulopathies.
Slovenian: • Odbor je po preučitvi razpoložljivih podatkov sklenil, da je benfluoreks pod normalnimi pogoji uporabe škodljiv, saj povzroča pljučno hipertenzijo in srčne valvulopatije.
English: • The Committee considered the benefit-risk ratio of benfluorex under the normal conditions of use and considered that the aforementioned proven risk of cardiac valve disease is not acceptable, taking into account that the benefit of benfluorex is only limited in the treatment of type 2 diabetes.
Slovenian: • Odbor je upošteval razmerje med koristmi in tveganji za benfluoreks pod normalnimi pogoji uporabe in menil, da zgoraj navedeno dokazano tveganje za bolezni srčnih zaklopk ni sprejemljivo glede na to, da so koristi benfluoreksa omejene le na zdravljenje sladkorne bolezni tipa 2.
English: Benfluorex has an action on carbohydrate metabolism.
Slovenian: Benfluoreks učinkuje na presnovo ogljikovih hidratov.
English: As stated in the MAH's written response, at the time of the national evaluation of the cardiac valvular abnormality, the MAH proposed to maintain benfluorex on the market with a restriction to the indication in patients with no ultrasound evidence of valve anomalies and the implementation of echocardiographic monitoring.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v pisnem odgovoru v trenutku nacionalnega vrednotenja nepravilnosti srčnih zaklopk predlagal, da benfluoreks ostane na trgu, vendar z omejitvijo na indikacijo pri bolnikih brez ultrazvočnih dokazov anomalij zaklopk in izvajanje ehokardiografskega opazovanja.
English: Benfluorex is used as an adjunct in the management of type 2 diabetes mellitus in overweight patients.
Slovenian: Benfluoreks se uporablja kot dodatek pri zdravljenju sladkorne bolezni tipa 2 pri bolnikih s prekomerno telesno maso.
English: The MAH projected to discontinue the treatment in the event of echocardiographic anomalies.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal prenehanje njegove uporabe pri zdravljenju ehokardiografskih anomalij.
English: Benfluorex is used as an “Adjuvant therapy of overweight diabetics, in combination with an appropriate diet”.
Slovenian: Benfluoreks se uporablja kot „adjuvantno zdravljenje prekomerno težkih bolnikov s sladkorno boleznijo v kombinaciji z ustrezno dieto“.
English: The updated results of the second national Pharmacovigilance survey, the preliminary data from 3 clinical studies (the retrospective case-control study performed in a Brest hospital, the REGULATE trial and the data from the French National Insurance Fund) and the recent publication from K. Boutet demonstrate the serious risk of cardiac morphological and functional valvulopathies and pulmonary hypertension associated with the use of benfluorex.
Slovenian: Posodobljeni podatki druge nacionalne raziskave farmakovigilance, uvodni podatki iz treh kliničnih študij (retrospektivne študije primerov in kontrol iz bolnišnice Brest, REGULATIVNEGA preskušanja ter podatkov francoskega nacionalnega zavarovalnega sklada) ter nedavna objava K. Boutet dokazujejo resno tveganje srčnih morfoloških in funkcionalnih valvulopatij ter pljučne hipertenzije, povezane z uporabo benfluoreksa.
English: • The Committee, in light of the above findings, concluded that the benefit/risk balance of benfluorex containing medicinal products is not favourable under the normal conditions of use.
Slovenian: • Odbor je na podlagi zgoraj navedenih ugotovitev sklenil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo benfluoreks, pod normalnimi pogoji uporabe ni ugodno.
English: Updated results of the pharmacovigilance survey regarding the risk of cardiac valve diseases with benfluorex and data from a recent publication on this subject (K. Boutet Fenfluramine-like cardiovascular side-effects of benfluorex, Eur Respir.
Slovenian: Posodobljeni rezultati raziskave farmakovigilance v zvezi s tveganjem za bolezni srčnih zaklopk zaradi uporabe benfluoreksa in podatki iz nedavne objave o tej temi (K. Boutet Fenfluramine-like cardiovascular side-effects of benfluorex (Fenfluraminu podobni kardiovaskularni neželeni učinki benfluoreksa), Eur Respir.
English: The decision of the French Competent Authority was based on updated results of a Pharmacovigilance (PV) survey, preliminary data from 3 clinical studies (the retrospective case-control study performed in a Brest hospital, the REGULATE trial and the data from the French National Insurance Fund) and from a recent publication (K. Boutet Fenfluramine-like cardiovascular side-effects of benfluorex, Eur Respir.
Slovenian: Odločitev francoskega pristojnega organa je temeljila na posodobljenih rezultatih raziskave farmakovigilance, predhodnih podatkih iz treh kliničnih študij (retrospektivne študije primerov in kontrol iz bolnišnice Brest, REGULATIVNEGA preskušanja ter podatkov francoskega nacionalnega zavarovalnega sklada) in nedavne objave (K. Boutet Fenfluramine-like cardiovascular side-effects of benfluorex (Fenfluraminu podobni kardiovaskularni neželeni učinki benfluoreksa), Eur Respir.
English: Benfluorex has no action on insulin-secretion.
Slovenian: Benfluoreks ne učinkuje na izločanje inzulina.
English: The Committee noted that morphological and functional valvular heart abnormalities can be seen after an average of only 328 days of exposure.
Slovenian: Odbor je ugotovil, da je morfološke in funkcionalne nepravilnosti srčnih zaklopk mogoče videti povprečno že po 328 dneh izpostavljenosti.
English: • The Committee noted that morphological and functional valvular heart abnormalities can be seen after an average of only 328 days of exposure.
Slovenian: • Odbor je ugotovil, da je morfološke in funkcionalne nepravilnosti srčnih zaklopk mogoče videti povprečno že po 328 dneh izpostavljenosti.
English: FR - France
Slovenian: Francija
English: The imprecision regarding information about the diagnosis of cardiac valve disease and the limited number of patients identified as presenting cardiac valve disease and treated with benfluorex (35 patients) were pointed out by the MAH.
Slovenian: Imetnik dovoljenja za promet z zdravilom je poudaril netočnost informacij glede diagnoze bolezni srčnih zaklopk in omejeno število bolnikov, ki so bili zdravljeni z benfluoreksom (35 bolnikov) in pri katerih je bila ugotovljena bolezen srčnih zaklopk.
English: Marketing Authorisation Holder Invented Name
Slovenian: Izmišljeno ime
English: Finally, on the basis of the available data sources, the CHMP is of the opinion that the number of spontaneous reports of cardiac valvulopathies associated with benfluorex is significantly underestimated due to limitations of data collected from spontaneous reporting in this situation such as:
Slovenian: Nenazadnje CHMP na podlagi razpoložljivih virov podatkov meni, da je število spontanih poročil o srčnih valvulopatijah, povezanih z uporabo benfluoreksa, bistveno podcenjeno zaradi omejenih podatkov, zbranih pri spontanih poročilih v zvezi s tem, kot npr: - vrsta učinka benfluoreksa (valvulopatija, ki ostane klinično asimptomatska dolgo časa); - čas do dogodka (spremembe na zaklopkah se pojavijo šele po zelo dolgem času izpostavljenosti benfluoreksu).
English: CY - Cyprus
Slovenian: Ciper
English: 150 mg coated tablet
Slovenian: Obložena tableta
English: Article 13 of Commission Regulation (EC) No. 1234/2008
Slovenian: Člen 13 Uredbe Komisije (ES) št. 1234/2008
English: The reference Member State (RMS) is France and 25 concerned Member States (CMS) are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom.
Slovenian: Referenčna država članica je Francija, zadevnih pa je naslednjih 25 držav članic: Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Finska, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija in Združeno kraljestvo.
English: The variation procedure (FR/V/0167/01/II/017) started on 28 January 2013.
Slovenian: Postopek za spremembo (FR/V/0167/01/II/017) se je začel 28. januarja 2013.
English: The opinion was converted into a Decision by the European Commission on 5 December 2014.
Slovenian: Mnenje je bilo 5. decembra 2014 spremenjeno v sklep Evropske komisije.
English: The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Slovenian: Odbor je imenoval Cornelio Ibrahim za poročevalko in Michaela Holzhauser-Albertija za soporočevalca.
English: Oral explanations were given on 10 September 2014.
Slovenian: Ustna pojasnila so bila podana 10. septembra 2014.
English: International non-proprietary name (INN): florfenicol, flunixin
Slovenian: Mednarodno nelastniško ime (INN): florfenikol, fluniksin
English: Opinion following an Article 13
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 13
English: The referral procedure started on 12 February 2014.
Slovenian: Napotitveni postopek se je začel 12. februarja 2014.
English: A single subcutaneous injection of 40 mg florfenicol and 2.2 mg flunixin per kg body weight (2 mL/15 kg bw) is recommended.
Slovenian: Priporočeno je enkratno subkutano injiciranje 40 mg florfenikola in 2,2 mg fluniksina na kg telesne mase (2 ml/15 kg telesne mase).
English: Day 60 of the CMD(v) procedure was on 23 January 2014, and since the Member States concerned failed to reach an agreement, the procedure was referred to the CVMP.
Slovenian: Šestdeseti dan postopka v skupini CMD(v) je bil 23. januarja 2014 in ker zadevne države članice niso dosegle soglasja, je bil postopek napoten na odbor CVMP.
English: Based on the evaluation of the available data the CVMP adopted by majority, on 7 October 2014, an opinion recommending the granting of the variation of the marketing authorisations for Resflor solution injectable and its associated names.
Slovenian: Na podlagi ocene razpoložljivih podatkov je odbor CVMP 7. oktobra 2014 z večino glasov sprejel mnenje, v katerem je priporočil odobritev spremembe dovoljenja za promet z zdravilom Resflor raztopina za injiciranje in povezanimi imeni.
English: On 24 January 2014, the reference Member State, France, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.
Slovenian: 24. januarja 2014 je referenčna država članica, Francija, obvestila Evropsko agencijo za zdravila, da skupina CMD(v) ni dosegla soglasja, in zadevo v skladu s členom 13(2) Uredbe Komisije (ES) št. 1234/2008 napotila na odbor CVMP.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics and package leaflet in Annex III.
Slovenian: Seznam zadevnih imen zdravil je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, Priloga III pa vsebuje povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Written explanations were provided by the marketing authorisation holder on 12 May 2014 and 19 June 2014.
Slovenian: zdravilom je predložil pisna pojasnila 12. maja 2014 in 19. junija 2014.
English: On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 25 November 2013.
Slovenian: Ker ti pomisleki na 90. dan postopka še vedno niso bili rešeni, je bila zadeva 25. novembra 2013 v skladu s členom 13(1) Uredbe Komisije (ES) št. 1234/2008 napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek (zdravila za uporabo v veterinarski medicini) (CMD(v)).
English: The marketing authorisation holder Intervet International BV submitted an application for a type II variation to add Mycoplasma bovis as a target pathogen.
Slovenian: Imetnik dovoljenja za promet z zdravilom, Intervet International BV, je predložil vlogo za spremembo tipa II, da bi dodali bakterijo Mycoplasma bovis med ciljne patogene.
English: Potential serious risks to animal health were identified during the decentralised procedure by Denmark and Germany regarding the demonstration of efficacy in the clinical trials and the justification of the recommended treatment dose of Resflor in the treatment of respiratory infections caused by Mycoplasma bovis, which may be associated with an increased risk of development of antimicrobial resistance.
Slovenian: Med decentraliziranim postopkom sta Danska in Nemčija opozorili na možna resna tveganja za zdravje živali, povezana z dokazovanjem učinkovitosti v kliničnih preskušanjih in utemeljitvijo priporočenega odmerka zdravila Resflor za zdravljenje okužb dihal, ki jih povzroča bakterija Mycoplasma bovis, saj bi lahko obstajalo povečano tveganje za razvoj protimikrobne odpornosti.
English: The CVMP concluded that the clinical benefit of Resflor in the treatment of respiratory infections associated with M. bovis has been demonstrated and no specific risk of antimicrobial resistance has been identified with the use of this product.
Slovenian: Odbor CVMP je zaključil, da je bila dokazana klinična korist zdravila Resflor pri zdravljenju okužb dihal, povezanih z bakterijo M. bovis, prav tako pa v povezavi z uporabo tega zdravila ni bilo ugotovljeno posebno tveganje za protimikrobno odpornost.
English: It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia.
Slovenian: Zdravilo je indicirano za zdravljenje okužb dihal, ki jih povzročajo bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni ter so povezane s povišano telesno temperaturo.
English: Resflor is a solution for injection for use in cattle containing florfenicol and flunixin as active ingredients.
Slovenian: Zdravilo Resflor je raztopina za injiciranje, namenjena za uporabo pri govedu, ki vsebuje zdravilni učinkovini florfenikol in fluniksin.
English: referral for Resflor solution injectable and associated names
Slovenian: za zdravilo Resflor raztopina za injiciranje in povezana imena
English: Opinion following an Article 13 referral for Resflor solution injectable and associated names
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 13 za zdravilo Resflor raztopina za injiciranje in povezana imena stran 2/2
English: This overview was last updated in 03-2018.
Slovenian: Povzetek je bil nazadnje posodobljen 03-2018.
English: IN addition, no infections occurred during the study period.
Slovenian: Poleg tega se v času študije niso pojavile nove okužbe.
English: It is used to treat the following conditions:
Slovenian: Uporablja se za zdravljenje naslednjih bolezni:
English: Further information on Hizentracan be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Nadaljnje informacije za zdravilo Hizentra so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The dose may need to be adjusted depending on how well the medicine is working.
Slovenian: Odmerek bo morda treba prilagoditi, odvisno od tega, kako dobro zdravilo deluje.
English: It may be given at home, while the side effects are manageable.
Slovenian: Daje se lahko doma, njegovi neželeni učinki pa so obvladljivi.
English: What measures are being taken to ensure the safe and effective use of Hizentra?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Hizentra?
English: It must not be injected into a blood vessel.
Slovenian: Ne sme se injicirati v krvno žilo.
English: The European Medicines Agency decided that Hizentra's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Hizentra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Other information about Hizentra
Slovenian: Druge informacije o zdravilu Hizentra
English: Normal immunoglobulin has been used as a medicine since the 1980s.
Slovenian: Polispecifični imunoglobulin se kot zdravilo uporablja od 80. let 20. stoletja.
English: It can also help to control the immune system when it is working abnormally such as in CIDP.
Slovenian: Pripomore lahko tudi k uravnavanju imunskega sistema pri njegovem nenormalnem delovanju, npr. pri CIDP.
English: Hizentra received a marketing authorisation valid throughout the EU on 14 April 2011.
Slovenian: Za zdravilo Hizentra je bilo 14. aprila 2011 izdano dovoljenje za promet, veljavno po vsej EU.
English: It contains mainly immunoglobulin G (IgG), which is composed of a range of antibodies involved in fighting organisms that can cause infection.
Slovenian: Vsebuje predvsem imunoglobulin G (IgG), ki ga sestavljajo različna protitelesa, udeležena v boju proti organizmom, ki lahko povzročajo okužbe.
English: The most common side effects with Hizentra (which may affect more than 1 in 10 people) are headache, rash, muscle and joint pain (including muscle spasm and weakness), reactions around the injection area (swelling, soreness, redness, pitting, warmth, itching, bruising and rash) and flu-like illness.
Slovenian: Najpogostejši neželeni učinki zdravila Hizentra (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so glavobol, izpuščaj, mišična in sklepna bolečina (vključno z mišičnimi krči in šibkostjo), reakcije v predelu injiciranja (otekanje, bolečine, luknjičavost, toplota, srbenje, podplutbe in izpuščaj) ter gripi podobna bolezen.
English: As for all medicines, data on the use of Hizentra is continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Hizentra stalno spremljajo.
English: Rarely patients may have a sudden drop in blood pressure or an anaphylactic shock (sudden, severe allergic reaction).
Slovenian: Redko lahko pri bolnikih nenadoma pade krvni tlak ali nastopi anafilaktični šok (nenadna, huda alergijska reakcija).
English: • chronic inflammatory demyelinating polyneuropathy (CIDP).
Slovenian: • kronični vnetni demielinizirajoči polinevropatiji (CIDP).
English: Hizentra is used in patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins.
Slovenian: Zdravilo Hizentra se uporablja pri bolnikih, katerih kri ne vsebuje dovolj protiteles (beljakovin, ki pomagajo telesu v boju proti okužbam in drugim boleznim), znanih tudi kot imunoglobulini.
English: What benefits of Hizentra have been shown in studies?
Slovenian: Kakšne koristi zdravila Hizentra so se pokazale v študijah?
English: Side effects reported with Hizentra are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Hizentra, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hizentra have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Hizentra upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Why is Hizentra authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Hizentra odobreno v EU?
English: • primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);
Slovenian: • sindromov primarne imunske pomanjkljivosti (pri ljudeh, ki se rodijo z nezmožnostjo proizvajanja zadostnega števila protiteles);
English: The patients received Hizentra for 28 weeks and the lowest IgG levels during treatment with Hizentra (average level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment.
Slovenian: Bolniki so zdravilo Hizentra prejemali 28 tednov, najnižje ravni imunoglobulina IgG pri zdravljenju z njim (povprečna raven 8,1 g na liter) pa so bile primerljive z ravnjo, opaženo med predhodnim zdravljenjem z imunoglobulinom.
English: An overview of Hizentra and why it is authorised in the EU
Slovenian: Pregled zdravila Hizentra in zakaj je odobreno v EU
English: The dose and how often Hizentra infusion is given depend on the disease being treated.
Slovenian: Odmerek in pogostost infuzije sta odvisna od zdravljene bolezni.
English: Hizentra can only be obtained with a prescription and treatment should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems or CIDP.
Slovenian: Predpisovanje in izdaja zdravila Hizentra je le na recept, zdravljenje z njim pa mora uvesti zdravnik ali medicinska sestra, ki ima izkušnje z zdravljenjem bolnikov z oslabljenim imunskim sistemom ali CIDP.
English: For more information about using Hizentra, see the package leaflet or contact a doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Hizentra glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Hizentra and what is it used for?
Slovenian: Kaj je zdravilo Hizentra in za kaj se uporablja?
English: What are the risks associated with Hizentra?
Slovenian: Kakšna tveganja so povezana z zdravilom Hizentra?
English: It is given by subcutaneous infusion (very slow injection under the skin) through a device that controls the speed of infusion.
Slovenian: Daje se kot infuzija v podkožje (zelo počasno injiciranje v podkožje) s pripomočkom, ki uravnava hitrost infundiranja.
English: • low levels of antibodies in the blood in patients with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) or myeloma (a cancer of another type of white blood cell) and who have frequent infections;
Slovenian: • nizke ravni protiteles v krvi bolnikov s kronično limfocitno levkemijo (rakom vrste belih krvnih celic) ali mielomom (rakom druge vrste belih krvnih celic) in pogosto ponavljajočimi se okužbami;
English: As human normal immunoglobulin has been used to treat these diseases for many years, in accordance with current guidelines, two small studies were needed to establish the effectiveness and safety of Hizentra in patients.
Slovenian: Ker se humani polispecifični imunoglobulin že dalj časa uporablja za zdravljenje teh bolezni, sta za potrditev učinkovitosti in varnosti zdravila Hizentra pri bolnikih v skladu z veljavnimi smernicami zadostovali le dve manjši študiji.
English: Patients received Hizentra or placebo (a dummy treatment) for 13 weeks and the study measured the proportion of patients in whom the disease came back within 13 weeks.
Slovenian: Bolniki so prejemali zdravilo Hizentra ali placebo (zdravilo brez učinkovine) 13 tednov, študija pa je merila delež bolnikov, pri katerih se je bolezen ponovila v 13 tednih.
English: Patients (or their carers) may inject Hizentra at home once they have been trained.
Slovenian: Bolniki ali njihovi skrbniki lahko po ustreznem usposabljanju zdravilo Hizentra injicirajo sami doma.