FrancophonIA/ELRC3.0 huggingface dataset:
English: When Coliprotec F4 is given to pigs, the animals' immune system recognises the bacteria as ‘foreign' and makes antibodies against them.
Slovenian: Ko prašiče cepimo z zdravilom Coliprotec F4, njihov imunski sistem bakterije prepozna kot „tujke“ in proti njim razvije protitelesa.
English: What benefit has Coliprotec F4 shown during the studies?
Slovenian: Kakšne koristi je zdravilo Coliprotec F4 izkazalo med študijami?
English: Other information about Coliprotec F4:
Slovenian: Druge informacije o zdravilu Coliprotec F4:
English: Coliprotec F4 is given to pigs from 18 days of age to reduce the incidence of moderate to severe post-weaning E. coli diarrhoea.
Slovenian: Zdravilo Coliprotec F4 se daje prašičem od 18. dneva starosti dalje za zmanjšanje pogostnosti zmerne do hude driske zaradi E. coli po odstavitvi.
English: Shivering may be seen in more than 1 in 10 pigs after vaccination.
Slovenian: Pri več kot 1 od 10 prašičev se lahko pojavi tresavica.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom defences) how to defend itself against a disease.
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom po odstavitvi, na svoji zunanji ovojnici pogosto tvorijo beljakovino, imenovano F4, zaradi katere se lahko vežejo na celice črevesja.
English: Coliprotec F4 is given orally to pigs as a single dose either as a drench or by addition to the drinking water.
Slovenian: Zdravilo Coliprotec F4 se prašičem daje peroralno v enkratnem odmerku, bodisi z drenažno aplikacijo bodisi z dodajanjem vodi za pitje.
English: The withdrawal period for Coliprotec F4 for pigs is zero days.
Slovenian: Karenca za zdravilo Coliprotec F4 za prašiče je nič dni.
English: What is the risk associated with Coliprotec F4?
Slovenian: Kakšna tveganja so povezana z zdravilom Coliprotec F4?
English: Why has Coliprotec F4 been approved?
Slovenian: Zakaj je bilo zdravilo Coliprotec F4 odobreno?
English: How has Coliprotec F4 been studied?
Slovenian: Kako je bilo zdravilo Coliprotec F4 raziskano?
English: What is Coliprotec F4?
Slovenian: Kaj je zdravilo Coliprotec F4?
English: What is Coliprotec F4 used for?
Slovenian: Za kaj se zdravilo Coliprotec F4 uporablja?
English: How does Coliprotec F4 work?
Slovenian: Kako zdravilo Coliprotec F4 deluje?
English: 10 (2 x 5 ) prefilled pens (multipack)
Slovenian: 10 (2 x 5) napolnjenih injekcijskih peresnikov (skupno pakiranje)
English: Invented name
Slovenian: Lastniško ime
English: 1 cartridge
Slovenian: 1 injekcijski vložek
English: Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: Farmacevtska oblika
English: Follow-up assessment after the referral under Article 35 of Directive 2001/82/EC (EMEA/V/A/089)
Slovenian: Naknadna ocena po napotitvenem postopku v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/089)
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 March 2018
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: These included data from companies and from the published literature.
Slovenian: Vključeni so bili podatki, ki so jih priskrbela podjetja, in podatki iz objavljene literature.
English: What are the conclusions of the CVMP after the follow-up assessment?
Slovenian: Kakšni so zaključki odbora CVMP po naknadni oceni?
English: Following review of the relevant information submitted in 2013 (during the initial phase of the referral procedure) and the additional data provided by the marketing authorisation holders as a follow-up of the Commission Implementing Decision (C(2014) 1484), in February 2018 the CVMP concluded that the outstanding concern over optimisation of the dosage regimen for the treatment of Escherichia coli infections was not resolved.
Slovenian: Po pregledu zadevnih informacij, predloženih v letu 2013 (med začetno fazo napotitvenega postopka), in dodatnih podatkov, ki so jih kot nadaljnji ukrep po izvedbenem sklepu Komisije (C(2014) 1484) predložili imetniki dovoljenj za promet z zdravili, je odbor CVMP februarja 2018 zaključil, da odprto vprašanje optimizacije sheme odmerjanja za zdravljenje okužb z bakterijo Escherichia coli ni bilo rešeno.
English: What is enrofloxacin?
Slovenian: Kaj je enrofloksacin?
English: EMA/184512/2018
Slovenian: marec 2018
English: It works against a broad spectrum of Gram-negative and Gram-positive bacteria as well as Mycoplasma spp.
Slovenian: Deluje proti širokemu spektru gramnegativnih in grampozitivnih bakterij ter mikroorganizmom Mycoplasma spp.
English: Enrofloxacin is for veterinary use only.
Slovenian: Enrofloksacin je namenjen samo za veterinarsko uporabo.
English: Enrofloxacin is an antibiotic belonging to class ‘fluoroquinolones'.
Slovenian: Enrofloksacin je antibiotik, ki spada v skupino fluorokinolonov.
English: The marketing authorisation holders were advised to contact the National Competent Authorities of the Member States in order to discuss the next steps for the implementation of CVMP's recommended changes to the product information.
Slovenian: Imetnikom dovoljenj za promet z zdravili je bilo svetovano, naj se obrnejo na pristojne nacionalne organe držav članic, da bi se z njimi dogovorili o naslednjih korakih pri uvedbi sprememb informacij o zdravilih, ki jih je priporočil odbor CVMP.
English: At that time, marketing authorisation holders were required to provide more data to justify the dosage of enrofloxacin used in poultry.
Slovenian: Takrat se je od imetnikov dovoljenj za promet z zdravili zahtevalo, naj predložijo več podatkov za utemeljitev odmerkov enrofloksacina, ki se uporabljajo pri perutnini.
English: The CVMP reviewed the available pre-clinical (laboratory) and clinical data (in chickens and turkeys) on enrofloxacin.
Slovenian: Odbor CVMP je pregledal razpoložljive predklinične (laboratorijske) in klinične podatke (pri piščancih in puranih) o enrofloksacinu.
English: The CVMP has now reviewed these data and has updated its recommendations on the use of enrofloxacin in chickens and turkeys.
Slovenian: Odbor CVMP je zdaj te podatke pregledal in posodobil priporočila za uporabo enrofloksacina pri piščancih in puranih.
English: In November 2013, the CVMP made recommendations for these products to ensure that they are used appropriately in chickens and turkeys, and to lower the risk of bacteria developing resistance to enrofloxacin.
Slovenian: Novembra 2013 je odbor CVMP za ta zdravila pripravil priporočila, da bi zagotovil, da se ustrezno uporabljajo pri piščancih in puranih, ter da bi zmanjšal tveganje za razvoj bakterij, odpornih proti enrofloksacinu.
English: The CVMP considered that the currently-approved dosage may accelerate development of bacterial resistance to enrofloxacin, which would limit its use as treatment of last resort for colibacillosis in poultry.
Slovenian: Odbor CVMP je menil, da lahko trenutno odobreno odmerjanje pospeši razvoj bakterijske odpornosti proti enrofloksacinu, kar bi omejilo njegovo uporabnost kot zdravila zadnje izbire za kolibacilozo pri perutnini.
English: The CVMP noted that the marketing authorisation holders had not demonstrated that the current dosage regimen for Escherichia coli in chickens and turkeys is optimal from a clinical perspective nor proposed a new dosage regimen.
Slovenian: Odbor CVMP je ugotovil, da imetniki dovoljenj za promet z zdravili niso dokazali, da je trenutna shema odmerjanja pri okužbi piščancev in puranov z bakterijo Escherichia coli optimalna s kliničnega vidika, niti niso predlagali nove sheme odmerjanja.
English: On 14 February 2018, the European Medicines Agency updated its recommendations for enrofloxacincontaining medicines administered via drinking water to chickens and turkeys.
Slovenian: 14. februarja 2018 je Evropska agencija za zdravila posodobila priporočila za zdravila, ki vsebujejo enrofloksacin in se dajejo piščancem in puranom v vodo za pitje.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these products should no longer be used in chickens and turkeys to treat Escherichia coli infections and that the product information for the products should be amended accordingly.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da se ta zdravila ne smejo več uporabljati za zdravljenje okužb z bakterijo Escherichia coli pri piščancih in puranih in da je treba ustrezno spremeniti informacije o zdravilu.
English: Therefore, the CVMP concluded that enrofloxacin should no longer be used for treatment of Escherichia coli infections in chickens and turkeys and recommended that the product information of the concerned products be amended accordingly.
Slovenian: Odbor CVMP je zato zaključil, da se enrofloksacin ne sme več uporabljati za zdravljenje okužb z bakterijo Escherichia coli pri piščancih in perutnini, in priporočil, da se za zadevna zdravila ustrezno spremenijo informacije o zdravilu.
English: Why were enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys reviewed?
Slovenian: Zakaj so bila pregledana zdravila za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in puranom v vodo za pitje?
English: Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys
Slovenian: Vprašanja in odgovori o uporabi zdravil v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in puranom v vodo za pitje
English: Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys EMA/184512/2018
Slovenian: Vprašanja in odgovori o uporabi zdravil v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in puranom v vodo za pitje stran 2/2
English: Alternative options are available.
Slovenian: Na voljo so alternativne možnosti.
English: 48 healthy volunteers (male and female) were planned to participate according to four sequential groups of twelve volunteers each.
Slovenian: Sodelovalo bi naj 48 zdravih prostovoljcev (moških in žensk) v štirih zaporednih skupinah s po dvanajst prostovoljci v posamezni skupini.
English: It is used for the short-term treatment of irritable, non-productive cough.
Slovenian: Uporablja se za kratkotrajno zdravljenje dražljivega neproduktivnega kašlja.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING CLOBUTINOL (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVIL, KI VSEBUJEJO KLOBUTINOL (glejte Dodatek I)
English: The study was prematurely discontinued on day 2 in the third group (720 mg dose group).
Slovenian: Študija je bila predčasno ustavljena 2. dan pri tretji skupini (skupini z odmerkom 720 mg).
English: All clobutinol containing medicinal products in the EU are authorised according to national procedures.
Slovenian: Vsa zdravila v EU, ki vsebujejo klobutinol, so odobrena v skladu z nacionalnimi postopki.
English: In addition, clobutinol-containing products are usually used outside structures where an adequate monitoring could be performed to prevent or detect QTc-prolongation related events.
Slovenian: Poleg tega se zdravila, ki vsebujejo klobutinol, navadno uporabljajo zunaj struktur, kjer bi bilo mogoče izvajati ustrezno spremljanje z namenom preprečevanja ali odkrivanja dogodkov, povezanih s podaljšanjem intervala QTc.
English: Medicinal products containing clobutinol have been available since 1961 and are authorised in a number of EU Member States (see Annex I for the list of clobutinol containing medicinal products authorised in the EU).
Slovenian: Zdravila, ki vsebujejo klobutinol, se uporabljajo od leta 1961 dalje in so odobrena v številnih državah članicah EU (glejte Dodatek I za seznam zdravil, vsebujočih klobutinol, ki so odobrena v EU).
English: • The Committee, in light of the above findings, concluded that the benefit/risk balance of clobutinol containing medicinal products is not favourable.
Slovenian: • Odbor je na podlagi zgoraj navedenih ugotovitev zaključil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo klobutinol, ni ugodno.
English: The CHMP discussed the matter at its September 2007 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started at the September 2007 CHMP meeting.
Slovenian: CHMP je o zadevi razpravljal na svojem plenarnem zasedanju septembra 2007, postopek v skladu s členom 107(2) Direktive 2001/83/ES, z vsemi spremembami, pa se je začel izvajati na zasedanju CHMP septembra 2007.
English: The multiple rising dose trial was randomised, double-blind and placebo controlled within dose groups.
Slovenian: Študija z več naraščajočimi odmerki je bila randomizirana, dvojno slepa in s placebom kontrolirana, s skupinami, oblikovanimi na podlagi odmerka.
English: The results show that the QT/QTc prolongation is clearly dose dependent.
Slovenian: Rezultati kažejo, da je podaljšanje QT/QTc nedvoumno odvisno od odmerka.
English: According to the ICH E14-Guideline (“The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs”, 2005) drugs “that prolong the mean QT/QTc interval by > 20 ms have a substantially increase likelihood of being proarrhythmic …”.
Slovenian: V skladu s Smernico ICH E14 („The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs“ [Klinična evalvacija podaljšanja intervala QT/QTc in proaritmogenega potenciala pri neantiaritmičnih zdravilih], 2005) obstaja pri zdravilih, „ki podaljšajo povprečni interval QT/QTc za > 20 ms, bistveno večja verjetnost, da so proaritmogena...“.
English: They include tablets, oral solutions, syrups and solutions for injection, and are available over-the-counter in many EU Member States.
Slovenian: So v obliki tablet, peroralnih raztopin, sirupov in raztopin za injiciranje ter se izdajajo brez recepta v številnih državah članicah EU.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR REVOCATION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA RAZVELJAVITEV DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: On 30 August 2007, the German Competent Authority (BfArM) issued a Rapid Alert informing the Members States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of its decision to suspend the marketing authorisation of all clobutinol containing medicinal products in Germany on 31 August 2007 due to an increased risk of serious arrhythmia associated with clobutinol.
Slovenian: Dne 30. avgusta 2007 je nemški pristojni organ (BfArM) sprožil hitri alarm in države članice, EMEA in Evropsko komisijo v skladu s členom 107 Direktive 2001/83/ES, kakor je bila spremenjena, obvestil o svoji odločitvi, da v Nemčiji z dnem 31. avgusta 2007 začasno ukine dovoljenje za promet z vsemi zdravili, vsebujočimi klobutinol, zaradi povečanega tveganja hude aritmije, povezane s klobutinolom.
English: At the same time as the decision of the BfArM to suspend all clobutinol containing medicinal products in Germany, Boehringer Ingelheim decided to withdraw voluntarily its clobutinol containing medicinal products worldwide from the market.
Slovenian: Hkrati z odločitvijo BfArM o začasnem preklicu vseh zdravil, vsebujočih klobutinol, v Nemčiji, se je družba Boehringer Ingelheim odločila, da bo prostovoljno s svetovnega trga umaknila vsa svoja zdravila, ki vsebujejo klobutinol.
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing clobutinol
Slovenian: • Odbor je obravnaval zadevo v skladu s členom 107 Direktive 2001/83/ES, z vsemi spremembami, za zdravila, ki vsebujejo klobutinol,
English: • The Committee considered that clobutinol is approved for a condition which is not lifethreatening and for which alternative treatments are available, and the expected benefit is only symptomatic; furthermore the CHMP took into account that clobutinol could be available over the counter
Slovenian: • Odbor je upošteval, da je klobutinol odobren za stanje, ki ni smrtno nevarno in za katero so na voljo alternativna zdravila, pričakovane koristi pa so zgolj simptomatske; CHMP je nadalje upošteval tudi dejstvo, da se klobutinol izdaja brez recepta,
English: • The Committee concluded, after having reviewed the available data, that clobutinol has a clear potential for QT prolongation
Slovenian: • Odbor je po pregledu razpoložljivih podatkov zaključil, da ima klobutinol nedvoumen potencial za podaljšanje intervala QT,
English: The decision of the German Competent Authority was based on newly available preliminary results from a clinical trial performed by Boehringer Ingelheim that have shown a prolongation of the QTc interval under treatment with clobutinol.
Slovenian: Odločitev nemškega pristojnega organa je temeljila na novih predhodnih rezultatih kliničnega preizkušanja, izvedenega s strani družbe Boehringer Ingelheim, ki so pokazali podaljšanje intervala QTc pri zdravljenju s klobutinolom.
English: Further to a publication (Bellocq et al., 2004) of a case of a young boy with a congenital long QTSyndrome who developed syncopes and Torsades de Pointes after intake of clobutinol, the German Competent Authority requested Boehringer Ingelheim to perform a preclinical investigational program and - at a later date - a clinical study to evaluate the risk of QT prolongation.
Slovenian: Po objavi (Bellocq et al., 2004) primera dečka s prirojenim sindromom dolgega intervala QT, pri katerem so se po jemanju klobutinola pojavile sinkope in „torsades de pointes“, je nemški pristojni organ od družbe Boehringer Ingelheim zahteval izvedbo predkliničnega preiskovalnega programa, pozneje pa še klinične študije za oceno tveganja za pojav podaljšanja intervala QT.
English: • The Committee concluded that the QT/QTc prolongation is clearly dose dependent and that the ICH E14 limits of 20 ms are clearly exceeded even under therapy with the highest recommended and approved dose (240 mg)
Slovenian: • Odbor je zaključil, da je podaljšanje intervala QT/QTc nedvoumno odvisno od odmerka in da je meja 20 ms, opredeljena v ICH E14, nedvoumno presežena tudi pri zdravljenju z največjim priporočljivim in odobrenim odmerkom (240 mg),
English: They are available as generic or branded medicines, mostly marketed by Boehringer Ingelheim under the trade name Silomat.
Slovenian: Na voljo so kot generična zdravila ali originatorska zdravila, ki jih pretežno trži družba Boehringer Ingelheim pod imenom Silomat.
English: Taking all these elements into account, the CHMP concluded that the benefit/risk ratio for clobutinol is not considered favourable and recommended the revocation of the Marketing Authorisations for the medicinal products referred to in Annex I. The CHMP also recommended that temporary measures are needed in view of the potentially life-threatening risk associated with QT prolongation and therefore recommends to the European Commission that the marketing and the use of clobutinol containing medicinal products be suspended forthwith in all concerned EU Member States awaiting the adoption of final measures.
Slovenian: Ob upoštevanju vseh teh elementov je CHMP sklenil, da razmerje med koristmi in tveganji za klobutinol ni ugodno, zato je priporočil razveljavitev dovoljenja za promet za zdravila iz Dodatka I. CHMP je tudi priporočil, da so z ozirom na potencialno smrtno nevarno tveganje, povezano s podaljšanjem intervala QT, potrebni začasni ukrepi, zato Evropski komisiji priporoča, da nemudoma zaustavi trženje in uporabo zdravil, ki vsebujejo klobutinol, v vseh zadevnih državah članicah EU, ki čakajo na sprejetje dokončnih ukrepov.
English: It was concluded that there is a potential risk of life-threatening arrhythmia under treatment with clobutinol.
Slovenian: Zaključeno je bilo, da obstaja pri zdravljenju s klobutinolom potencialno tveganje za smrtno nevarno aritmijo.
English: Clobutinol is a synthetic non-opioid cough suppressant.
Slovenian: Klobutinol je sintetično neopioidno zdravilo za pomirjanje kašlja (antitusik).
English: The observed maximum mean increase of QTc interval at one specific time point was 32 ms for the 240 mg daily dose, 43 ms for the 480 mg daily dose and 54 ms for the 720 mg daily dose.
Slovenian: Opaženo maksimalno povprečno povečanje intervala QTc v določeni časovni točki je bilo 32 ms pri dnevnem odmerku 240 mg, 43 ms pri dnevnem odmerku 480 mg in 54 ms pri dnevnem odmerku 720 mg.
English: The non-clinical study results indicate that clobutinol has a potential to prolong the QTc interval.
Slovenian: Rezultati neklinične študije kažejo, da ima klobutinol potencial za podaljšanje intervala QTc.
English: Clobutinol is a non-opioid cough suppressant and the expected benefit is symptomatic.
Slovenian: Klobutinol je neopioidno zdravilo za pomirjanje kašlja, njegove pričakovane koristi so simptomatske.
English: Boehringer Ingelheim performed both in vitro and in vivo electrophysiological studies in order to further characterise the torsadogenic potential of clobutinol.
Slovenian: Družba Boehringer Ingelheim je izvedla elektrofiziološki študiji in vitro in in vivo, da bi podrobneje opredelila potencial klobutinola za povzročitev „torsades de pointes“.
English: The ICH E 14 limits of 20 ms are clearly exceeded even under therapy with the highest recommended and approved dose (240 mg).
Slovenian: Meja v višini 20 ms, opredeljena v ICH E 14, je nedvoumno presežena tudi pri zdravljenju z največjim priporočljivim in odobrenim odmerkom (240 mg).
English: To further investigate the torsadogenic potential of clobutinol a multiple rising dose study in healthy volunteers with doses exceeding the highest recommended therapeutic dose of 80 mg clobutinol t.i.d.
Slovenian: Da bi podrobneje preučila potencial klobutinola za povzročitev „torsades de pointes“, je družba Boehringer Ingelheim izvedla študijo z več naraščajočimi odmerki pri zdravih prostovoljcih, v kateri so odmerki presegali največji priporočeni terapevtski odmerek 80 mg klobutinola trikrat dnevno.
English: These preliminary clinical trial results show a strong QT prolongation potential in healthy volunteers.
Slovenian: Ti predhodni rezultati kliničnega preizkušanja kažejo močan potencial za podaljšanje intervala QT pri zdravih prostovoljcih.
English: The preliminary clinical trial results show a strong QT prolongation potential in healthy volunteers.
Slovenian: Predhodni rezultati kliničnega preizkušanja kažejo močan potencial za podaljšanje intervala QT pri zdravih prostovoljcih.
English: The primary objective of the study was to investigate safety parameters with special emphasis on ECG (electrocaridiogram), tolerability and pharmacokinetics of clobutinol in healthy male and female volunteers following oral administration of a 80 mg single dose and of repeated rising doses of t.i.d.
Slovenian: Primarni cilj študije je bil preučiti varnostne parametre s posebnim poudarkom na EKG (elektrokardiogramu), prenašanju in farmakokinetiki klobutinola pri zdravih prostovoljcih in prostovoljkah po peroralnem dajanju enkratnega odmerka 80 mg in ponavljajočih se naraščajočih odmerkih 80 mg (= maksimalni priporočeni terapevtski odmerek), 160 mg, 240 mg in 320 mg trikrat dnevno 7 dni ter končnega odmerka zjutraj 8. dan (= skupno 8 dni).