natgillin/translations-raw huggingface dataset:
Each patch of 15 cm2 contains 8.25 mg fentanyl.
1 obliž (aktivna površina: 15 cm2) vsebuje 8,25 mg fentanila (ustreza hitrosti sproščanja učinkovine 50 mikrogramov/h).
- if you suffer from pain which lasts only for a short period, e. g. after a surgical procedure.
- za akutne ali pooperativne bolečine, ki trajajo le kratek čas.
Conditions for lifting the suspension of the manufacturing authorisation
Pogoji za preklic začasnega umika dovoljenja za proizvodnjo zdravila
Registration of a manufacturing site for the active substance, finished product and batch release.
Za preklic začasnega umika mora imetnik dovoljenja za promet z zdravilom MACI zagotoviti naslednje: Registrirati mesto za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje serij.
8 October 2012
8. oktober 2012
Article 34 of Directive 2001/82/EC
Člen 34 Direktive 2001/82/ES
The referral procedure started on 11 November 2010.
Napotitveni postopek se je začel 11. novembra 2010.
The Committee adopted a positive opinion by majority on 14 June 2012.
Odbor je večinsko pozitivno mnenje sprejel 14. junija 2012.
The final opinion was converted into a Decision by the European Commission on 8 October 2012.
Končno mnenje je bilo v sklep Evropske komisije spremenjeno dne 8. oktobra 2012.
The condition on the marketing authorisations is in Annex IV.
Pogoj za dovoljenja za promet z zdravilom je v Prilogi IV.
The Committee appointed Mrs Ruth Kearsley, who was later replaced by Ms Helen Jukes, as rapporteur and Dr Lotte Winther, who was later replaced by Dr Ellen-Margrethe Vestergaard, as co-rapporteur.
Odbor je za poročevalko imenoval Ruth Kearsley, ki jo je pozneje nadomestila Helen Jukes, za soporočevalko pa dr. Lotte Winther, ki jo je pozneje nadomestila dr. Ellen-Margrethe Vestergaard.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics, labelling and package leaflet are in the Annex III.
Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremenjenim povzetkom glavnih značilnosti zdravila, označevanjem in navodilom za uporabo v Prilogi III.
Due to divergent national decisions taken by Member States with respect to e.g. target species, indications, amounts to be administered and withdrawal periods concerning the authorisations of Baytril 10% oral solution and its associated names, on 15 October 2010 the United Kingdom referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised product information across the European Union.
Zaradi razhajajočih se nacionalnih odločitev držav članic glede npr. ciljnih vrst, indikacij, odmerjanja in karenc v zvezi z odobritvijo zdravila Baytril 10 % peroralna raztopina in povezanih imen je 15. oktobra 2010 Združeno kraljestvo napotilo zadevo na odbor CVMP v skladu s členom 34(1) Direktive 2001/82/ES, da razreši neskladja med nacionalno odobrenimi informacijami o zdravilu po vsej Evropski uniji.
Written explanations were provided by the marketing authorisation holders on 12 August 2011 and 14 February 2012.
Imetniki dovoljenja za promet z zdravilom so 12. avgusta 2011 in 14. februarja 2012 predložili pisna pojasnila ter 14. maja 2012 še ustna pojasnila.
Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylic acid derivatives.
Enrofloksacin je sintetično kemoterapevtsko sredstvo iz skupine derivatov fluorokinolon karboksilne kisline.
The products are authorised for use in the target species chickens, turkeys and rabbits for treatment of the respiratory tract and of the digestive tract infections caused by bacteria susceptible to enrofloxacin.
Zdravila so odobrena za ciljne vrste piščancev, puranov in kuncev za zdravljenje okužb dihal in prebavil, ki jih povzročajo bakterije, občutljive za enrofloksacin.
Baytril 10% oral solution and its associated names contain 100 mg enrofloxacin per ml oral solution for use in drinking water.
Zdravilo Baytril 10 % peroralna raztopina in povezana imena vsebuje 100 mg enrofloksacina na mililiter peroralne raztopine za uporabo v pitni vodi.
Opinion following an Article 341 referral for Baytril 10% oral solution and associated names
Mnenje v zvezi z napotitvijo v skladu s členom 341 za zdravilo Baytril 10 % peroralna raztopina in povezana imena
Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit-risk profile of Baytril 10% oral solution and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information,
Na podlagi poročevalkine ocene trenutno razpoložljivih podatkov je odbor CVMP presodil, da razmerje med koristmi in tveganji za zdravilo Baytril 10 % peroralna raztopina in povezana imena ostane
and subject to a condition on the marketing authorisations.
pozitivno, ob upoštevanju spremembe dovoljenj za promet z zdravilom v skladu s priporočenimi informacijami o zdravilu in pogoja, ki zadeva dovoljenja za promet z zdravilom.
Enrofloxacin is for veterinary use only.
Namenjen je le za uporabo v veterinarski medicini.
Opinion following an Article 340F referral for Baytril 10% oral solution and associated names
Mnenje v zvezi z napotitvijo v skladu s členom 340F za zdravilo Baytril 10 % peroralna raztopina in povezana imena EMA/511421/2012
and concluded that all relevant elements had already been considered by PRAC.
), in sklenila, da je vse pomembne elemente že proučil odbor PRAC.
Therefore, the conclusions of the PRAC are not affected.
Zato na sklepe odbora PRAC to ne vpliva.
However, some risk factors of TdP like congenital long QT syndrome are usually silent and unpredictable.
Vendar so nekateri dejavniki tveganja za TdP, kot je kongenitalni sindrom dolgega intervala QT, običajno tihi in nepredvidljivi.
In conclusion, no feasible and effective measures could be identified which would minimise this risk to an acceptable level.
Če povzamemo, izvedljivih in učinkovitih ukrepov, ki bi to tveganje zmanjšali na sprejemljivo raven, ni mogoče določiti.
The PRAC adopted a recommendation on 16 May 2019 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Odbor PRAC je 16. maja 2019 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnavala skupina CMDh.
No other appropriate measure was identified that would reduce the risk of QT prolongation to an acceptable level.
Ugotovljen ni bil noben drug primeren ukrep, ki bi zmanjšal tveganje podaljšanja intervala QT na sprejemljivo raven;
It is noted that lack of ECG diagnosis is common in these cases, which generates significant uncertainty on the actual incidence of TdP.
Navesti je treba, da je pri teh primerih pogosto pomanjkanje diagnoze z EKG, kar ustvarja znatno negotovost glede dejanske pojavnosti TdP.
These very low margins may have also been overestimated (i.e. plasma concentrations corresponding to the maximum daily doses were not determined, not clear whether the analysis was performed at steady state plasma concentrations or not).
Te zelo nizke meje so morda tudi precenjene (tj. plazemske koncentracije, ki ustrezajo največjim dnevnim odmerkom, niso bile določene; ni jasno, ali je bila analiza izvedena pri plazemskih koncentracijah v stanju dinamičnega ravnotežja ali ne).
The French Competent Authority (ANSM) considered that these results taken together with pharmacovigilance data support the risk of prolongation of the QTc interval in these patients.
Francoski pristojni organ (ANSM) je menil, da ti rezultati skupaj s farmakovigilančnimi podatki podpirajo tveganje za podaljšanje intervala QTc pri teh bolnikih.
The CMDh considered the arguments presented in writing by one MAH (Aflofarm Farmacja Polska Sp. Z O.O.)
Skupina CMDh je preučila utemeljitve, ki jih je pisno predstavil imetnik dovoljenja za promet z zdravilom (Aflofarm Farmacja Polska Sp. Z O.O.
On 8 February 2019 the French Competent Authority (ANSM) therefore triggered an urgent Union procedure under Article 107i of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of fenspiride containing medicinal products and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Francoski pristojni organ (ANSM) je tako 8. februarja 2019 na podlagi farmakovigilančnih podatkov sprožil nujni postopek Unije v skladu s členom 107i Direktive 2001/83/ES in odbor PRAC zaprosil, naj oceni vpliv navedenih pomislekov na razmerje med koristmi in tveganji zdravil, ki vsebujejo fenspirid, ter izda priporočilo o tem, ali je treba zadevna dovoljenja za promet z zdravilom ohraniti, spremeniti, začasno umakniti ali ukiniti.
Considering the seriousness of TdP which can lead to fatal outcome, a thorough risk analysis would be essential for each individual patient prior to treatment initiation with fenspiride.
Glede na resnost TdP, ki lahko povzroči smrten izid, bi bila pred začetkom zdravljenja s fenspiridom pri vsakem posameznem bolniku nujna natančna analiza tveganja.
The PRAC further noted that in view of the low safety margin calculated at doses below the therapeutic effect dose, reducing the dose would not permit to reduce the risk to an acceptable level.
Odbor PRAC je poleg tega navedel, da glede na nizko varnostno mejo, izračunano pri odmerkih, ki so manjši od terapevtsko učinkovitih, zmanjševanje odmerka ne bi omogočilo zmanjšanja tveganja na sprejemljivo raven.
This included the results of the above-mentioned requested non-clinical study (Aptuit), two other non-clinical studies and post-marketing case-reports as well as published efficacy studies.
Vanje so bili vključeni rezultati prej omenjene zahtevane neklinične študije (podjetja Aptuit), dveh drugih nekliničnih študij in poročila o primerih med dejavnostmi v obdobju trženja ter objavljene študije o učinkovitosti.
• The PRAC considered the procedure under Article 107i of Directive 2001/83/EC, for fenspiridecontaining medicinal products (see Annex I).
• odbor PRAC je obravnaval postopek v skladu s členom 107i Direktive 2001/83/ES za zdravila, ki vsebujejo fenspirid (glejte Prilogo I);
The PRAC considered that in view of the available data the generation of additional evidence via an ICH E14 thorough QT/QTc clinical study would not be justified and would not allow identifying defined patient population in whom the benefits could outweigh the risks.
Odbor PRAC je menil, da ustvarjanje dodatnih dokazov z natančno klinično študijo ICH E14 intervala QT/QTc glede na razpoložljive podatke ne bi bilo upravičeno in ne bi omogočalo določanja opredeljene populacije bolnikov, pri katerih bi bile koristi večje od tveganj.
In addition, no protective effects regarding the triggering of TdP arrhythmias (blockade of Nav1.5 and cardiac L-type Ca2+ channels) was shown for fenspiride.
Poleg tega pri fenspiridu ni bilo dokazanih nobenih zaščitnih učinkov v zvezi s sproženjem aritmij TdP (blokada kanalčkov Nav1.5 in kanalčkov Ca2+ srčne mišice tipa L).
• Taking into account that these medicinal products are only used to treat benign symptoms, the PRAC considered that no feasible and proportionate measures would effectively allow identifying patients with risk factors for QT prolongation and TdP, and that therefore any related risk minimisation measures could not be implemented in clinical practice.
• ob upoštevanju dejstva, da se ta zdravila uporabljajo le za zdravljenje benignih simptomov, je odbor PRAC sklenil, da nobeni izvedljivi in sorazmerni ukrepi ne bi učinkovito omogočali določanja bolnikov, pri katerih so prisotni dejavniki tveganja za podaljšanje intervala QT in TdP, ter da zato v klinični praksi ni mogoče uvesti nobenih s tem povezanih ukrepov za zmanjševanje tveganja.
Fenspiride-containing medicinal products are authorised nationally for the treatment of symptoms (e.g. cough and expectoration) related to bronchopulmonary diseases.
Zdravila, ki vsebujejo fenspirid, so bila odobrena po nacionalnih postopkih za zdravljenje simptomov (npr. kašlja in izkašljevanja), povezanih z bronhopulmonarnimi boleznimi.
• The PRAC reviewed the totality of the data available for fenspiride-containing medicinal products in relation to the risk of QT prolongation.
• odbor PRAC je pregledal vse razpoložljive podatke za zdravila, ki vsebujejo fenspirid, v zvezi s tveganjem podaljšanja intervala QT.
There is a possibility that the IC50 value is overestimated (i.e. experiments performed at room temperature, external K+ concentration in the milieu unknown, no DMSO cells perfusion before adding fenspiride in DMSO yet substracting DMSO effect) and fenspiride could be a more potent blocker of hERG channels than shown in vitro.
Obstaja možnost, da je vrednost IC50 precenjena (tj. da so bili poskusi izvedeni pri sobni temperaturi, da je bila zunanja koncentracija K+ v okolju neznana, da pred dodajanjem fenspirida v DMSO celice niso bile perfundirane, odštet pa je bil učinek DMSO) in da je fenspirid močnejši zaviralec kanalčkov hERG, kot je dokazano in vitro.
The calculated safety margins between the hERG IC50 obtained and the effective therapeutic plasma concentration for fenspiride, was below the lowest acceptable safety margin proposed in the literature (between 6 and 26, depending on the pharmaceutical form/dose administered and on the administration schedule).
Izračunane varnostne meje med pridobljeno vrednostjo IC50 kanalčka hERG in učinkovito terapevtsko plazemsko koncentracijo za fenspirid so bile nižje od najnižje sprejemljive varnostne meje, predlagane v literaturi (med 6 in 26, odvisno od farmacevtske oblike/danega odmerka in sheme dajanja).
QT prolongation and TdP are unpredictable and potentially life-threatening conditions that constitute a major safety concern, particularly given the benign symptoms for which fenspiride-containing medicinal products are used to treat.
Podaljšanje intervala QT in TdP sta nepredvidljivi in potencialno življenje ogrožajoči stanji, ki pomenita resen varnostni pomislek, še posebno glede na benigne simptome, za zdravljenje katerih se uporabljajo zdravila, ki vsebujejo fenspirid;
Calculated safety margins between the hERG inhibition concentration and the effective therapeutic plasma concentration were below the lowest acceptable margin proposed in the literature for administration in humans.
Izračunane varnostne meje med koncentracijo zaviranja kanalčka hERG in učinkovito terapevtsko plazemsko koncentracijo so bile nižje od najnižje sprejemljive meje, ki je v literaturi predlagana za uporabo pri ljudeh.
It has also been shown in a recent ex vivo study on isolated guinea pig hearts that the hERG blockade exerted by fenspiride may translate into QT prolongation in a similar concentration range as observed in the hERG study.
V nedavni študiji izoliranih src morskih prašičkov ex vivo je bilo tudi dokazano, da se blokada kanalčkov hERG, ki jo povzroči fenspirid, lahko pretvori v podaljšanje intervala QT pri podobni koncentraciji, kot je bila opažena v študiji hERG.
Additionally, unspecific terms of syncope, loss of consciousness, tachycardia and palpitations that may (among others) be signs and symptoms of TdP were present in a significant number of cases.
Poleg tega so bili v znatnem številu primerov prisotni nespecifične dobe sinkope, izguba zavesti, tahikardija in palpitacije, ki so (med drugim) lahko znaki in simptomi TdP.
Fenspiride has been shown in the Aptuit study to block hERG channels at supratherapeutic doses in vitro in a heterologous expression system, with an IC50 value of 15.14 µM.
V študiji podjetja Aptuit so dokazali, da fenspirid v supraterapevtskih odmerkih in vitro v sistemu heterolognega izražanja blokira kanalčke hERG z vrednostjo IC50, ki znaša 15,14 µM.
In addition, no effect of fenspiride was observed on the PR or QRS complex of the ECG, suggesting that fenspiride has no significant effect on other cardiac channels and no compensatory action of hERG blockade in vivo.
Poleg tega pri kompleksu PR ali QRS EKG-ja ni bil opažen učinek fenspirida, kar kaže na to, da ta nima pomembnega učinka na druge kanalčke v srčni mišici in na blokado hERG in vivo ne deluje kompenzacijsko.
Regarding clinical data, analysis of post-marketing cases reported since the marketing authorisation showed evidence to support a causal association between occurrence of QT prolongation/TdP in patients, mostly with risk factors for these events, and the treatment with fenspiride-containing medicinal products.
V zvezi s kliničnimi podatki so bili z analizo primerov med dejavnostjo v obdobju trženja, o katerih so poročali od podelitve dovoljenja za promet z zdravilom, podani dokazi, ki podpirajo vzročno povezavo med pojavnostjo podaljšanja intervala QT/TdP pri bolnikih, pri katerih večinoma obstajajo dejavniki tveganja za te dogodke, in zdravljenjem z zdravili, ki vsebujejo fenspirid.
In summary based on non-clinical assays of the accepted surrogate markers of TdP, i.e. blockade of hERG tail current and prolongation of the QT/QTc interval, and on post-marketing spontaneous reports of confirmed cases of TdP, QT prolongation and ventricular fibrillation/arrhythmia, the risk of QT prolongation, a proarrhythmic potential and associated risk of TdP is considered confirmed with fenspiride use.
Na podlagi nekliničnih testov sprejetih nadomestnih markerjev TdP, tj. blokade poznega toka kanalčka hERG in podaljšanja intervala QT/QTc, ter spontanih poročil o potrjenih primerih TdP, podaljšanju intervala QT in ventrikularni fibrilaciji/aritmiji skratka velja, da proaritmični potencial in s tem povezano tveganje TdP pri uporabi fenspirida veljata za potrjena.
Taking into account that fenspiride is indicated to treat benign symptoms and the seriousness of the risk of unpredictable QT prolongation leading to proarrhythmic potential in human, the ANSM concluded that the benefit-risk balance of fenspiride-containing medicinal products was no longer favourable in the treatment of symptoms related to bronchopulmonary diseases, and suspended the marketing authorisations of these products.
Ob upoštevanju dejstva, da je fenspirid indiciran za zdravljenje benignih simptomov, in resnosti tveganja za nepredvidljivo podaljšanje intervala QT, ki pri ljudeh povzroča proaritmični potencial, je sklenil, da razmerje med tveganji in koristmi zdravil, ki vsebujejo fenspirid, ni ugodno pri zdravljenju simptomov, povezanih z bronhopulmonarnimi boleznimi, ter je začasno umaknil dovoljenja za promet s temi zdravili.
Newly available results of two non-clinical studies showed that fenspiride can induce an inhibition of hERG tail current in vitro, and increase the corrected QT (QTc) intervals in isolated and perfused guinea pig heart.
Rezultati dveh novih nekliničnih študij so pokazali, da fenspirid lahko sproži zaviranje poznega toka kanalčka hERG in vitro ter podaljša popravljene intervale QT (QTc) v izoliranem in perfundiranem srcu morskega prašička.
• Further, the PRAC could not identify condition(s) to the marketing authorisation which if fulfilled would demonstrate a positive benefit-risk balance for these products in a defined patient population.
• odbor PRAC tudi ni mogel določiti pogojev za dovoljenje za promet z zdravilom, ki bi ob izpolnitvi dokazali pozitivno razmerje med tveganji in koristmi teh zdravil pri opredeljeni populaciji bolnikov,
In in silico models, fenspiride induced QT prolongation and “early afterdepolarizations” (EADs; arrhythmic makers) in specific cardiovascular disease state models.
Na modelih in silico je fenspirid v posebnih modelih s stanjem kardiovaskularne bolezni sprožil podaljšanje intervala QT in „zgodnje naknadne depolarizacije“ (EAD; povzročiteljice aritmij).
Therefore, the PRAC concluded that the risk of QT prolongation, the proarrhythmic potential and associated risk of TdP outweighs the benefits of fenspiride in its authorised indication(s).
Zato je odbor PRAC sklenil, da je tveganje podaljšanja intervala QT, proaritmičnega potenciala in s tem povezanega tveganja za TdP večje od koristi fenspirida pri njegovih odobrenih indikacijah.
This included the results of non-clinical studies and post-marketing case reports as well as published efficacy studies submitted by the MAHs, by stakeholders and provided by EMA.
Med njimi so bili tudi rezultati nekliničnih študij in poročila o primerih med dejavnostmi v obdobju trženja ter študije učinkovitosti, ki so jih predložili imetniki dovoljenja za promet, zainteresirane strani in Evropska agencija za zdravila;
• The PRAC considered that the use of fenspiride is associated with a risk of QT prolongation, and therefore it has proarrhythmic potential and present a risk of Torsade de Pointes (TdP).
• odbor PRAC je menil, da je uporaba fenspirida povezana s tveganjem podaljšanja intervala QT, zato ima proaritmični potencial in pomeni tveganje za polimorfno ventrikularno tahikardijo
The PRAC considered all data submitted by the MAHs, received from stakeholders and provided by EMA.
Odbor PRAC je upošteval vse podatke, ki so jih predložili imetniki dovoljenja za promet z zdravilom, podatke, ki jih je prejel od zainteresiranih strani, in podatke, ki jih je predložila Evropska agencija za zdravila.
The Committee, as a consequence, considers that the benefit-risk balance of fenspiride-containing medicinal products is no longer favourable.
odbor PRAC posledično meni, da razmerje med tveganji in koristmi zdravil, ki vsebujejo fenspirid, ni več ugodno.
The CMDh, as a consequence, considers that the benefit-risk balance of fenspiride-containing medicinal products is not favourable.
Posledično skupina CMDh meni, da razmerje med tveganji in koristmi zdravil, ki vsebujejo fenspirid, ni ugodno.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for fenspiride-containing medicinal products.
Zato v skladu s členom 116 Direktive 2001/83/ES priporoča ukinitev dovoljenj za promet z zdravili, ki vsebujejo fenspirid.
Therefore, pursuant to Article 116 of Directive 2001/83/EC, the CMDh recommends the revocation of the marketing authorisations for fenspiride-containing medicinal products.
Zato skupina CMDh v skladu s členom 116 Direktive 2001/83/ES priporoča ukinitev dovoljenj za promet z zdravili, ki vsebujejo fenspirid.
Consequently, the PRAC recommended the revocation of the marketing authorisations for fenspiride-containing medicinal products.
Zato je priporočil ukinitev dovoljenj za promet z zdravili, ki vsebujejo fenspirid.
The observed prolongation may be underestimated in this study due to the necessary QT correction formula of the observed dose-dependent QTc augmentations, in view of the method used.
Zaradi formule za popravek intervala QT, ki je potrebna pri opaženih povečanjih intervala QTc, odvisnih od odmerka, je podaljšanje, opaženo v študiji, glede na uporabljeno metodo morda podcenjeno.
In addition, performing ECG or measurements of potassium or magnesium levels is neither considered proportionate in pre-treatment screening for a medicinal product solely used to treat benign symptoms of generally self-limiting conditions, nor feasible in clinical practice.
Poleg tega pri presejanju pred zdravljenjem z zdravilom, uporabljanim izključno za zdravljenje benignih simptomov stanj, ki so običajno samoomejujoča, izvedba EKG ali meritev ravni kalija ali magnezija ne velja za sorazmerno in tudi ne za izvedljivo v klinični praksi.
Further, the PRAC could not identify condition(s) which if fulfilled would demonstrate a positive benefitrisk balance for these products in a defined patient population.
Odbor tudi ni mogel določiti pogojev, ki bi ob izpolnitvi pri opredeljeni populaciji bolnikov dokazali pozitivno razmerje med tveganji in koristmi teh zdravil.
The PRAC noted that this conclusion was also reached by the MAH of the originator.
Navedel je, da je enako sklenil tudi imetnik dovoljenja za promet z zdravilom originatorja.