FrancophonIA/ELRC3.0 huggingface dataset:
English: This is of particular concern as patients with peripheral vascular disease are inherently likely to experience decreased renal function due to the nature of their condition.
Slovenian: To je še zlasti zaskrbljujoče zaradi bolnikov s periferno žilno boleznijo, pri katerih je verjetnost za zmanjšano delovanje ledvic inherentna zaradi narave njihove bolezni.
English: In these enquires, the reported nervous system SAEs consisted mainly of convulsions, myoclonia and status epilepticus while the cardiac SAEs consisted mainly of tachycardia, hypotension, ventricular rhythm disorders and cardiac arrest.
Slovenian: V teh preiskavah so sporočeni resni neželeni dogodki živčnega sistema obsegali predvsem krče, mioklonijo in epileptični status, resni neželeni dogodki srca pa so obsegali predvsem tahikardijo, hipotenzijo, ventrikularno motnjo ritma in srčni zastoj.
English: Regarding risk minimisation measures, the CHMP noted the MAH proposals but considered that these are unlikely to be sufficient to prevent the occurrence of serious cardiac and neurological adverse events under normal conditions of use nor reduce the well identified risks of accidental overdoses and non-compliance with renal function monitoring associated with the use of buflomedil to an acceptable level.
Slovenian: Glede ukrepov za zmanjšanje tveganj je CHMP upošteval predloge imetnika dovoljenja za promet z zdravilom, vendar je menil, da verjetno ne bodo zadoščali za preprečevanje pojava resnih neželenih učinkov za srce in nevroloških neželenih učinkov pri običajnih pogojih uporabe ali za zmanjšanje dobro znanih tveganj nenamernega prevelikega odmerjanja in tudi ne bodo privedli do rutinskega nadziranja delovanja ledvic, povezanega z uporabo buflomedila.
English: With regards to safety, the CHMP concluded that the use of buflomedil is associated with a number of serious cardiological (mainly tachycardia, hypotension, ventricular rhythm disorders and cardiac arrest) and neurological (mainly convulsions, myoclonia and status epilepticus) adverse events, which occur under normal conditions of use, particularly in elderly patients, who are predominantly the patient population relevant to the approved indication.
Slovenian: Glede varnosti je CHMP zaključil, da je uporaba buflomedila povezana s številnimi resnimi kardiološkimi (predvsem tahikardijo, hipotenzijo, ventrikularno motnjo ritma in srčnim zastojem) in nevrološkimi (predvsem krči, mioklonijo in epileptičnim statusom) neželenimi učinki, ki so se pojavili v običajnih pogojih uporabe, zlasti pri starejših bolnikih, ki predstavljajo pretežno populacijo bolnikov za odobreno indikacijo.
English: In summary, the CHMP concluded that the use of buflomedil is associated with a number of serious cardiological (mainly tachycardia, hypotension, ventricular rhythm disorders and cardiac arrest) and neurological (mainly convulsions, myoclonia and status epilepticus) adverse events, which occur under normal conditions of use, particularly in elderly patients, who are predominantly the patient population relevant to the approved indication.
Slovenian: Povzetek sklepa CHMP je, da je uporaba buflomedila povezana s številnimi resnimi kardiološkimi (predvsem tahikardijo, hipotenzijo, ventrikularno motnjo ritma in srčnim zastojem) in nevrološkimi (predvsem krči, mioklonijo in epileptičnim statusom) neželenimi učinki, ki so se pojavili v običajnih pogojih uporabe, zlasti pri starejših bolnikih, ki predstavljajo pretežno populacijo bolnikov za odobreno indikacijo.
English: The MAH review of the ICSR database identified 33 cases involving the use of a maximum daily dose of 600 mg. From these, a total of 21 cases of neurological adverse events were retrieved.
Slovenian: V pregledu podatkovne baze ICSR je imetnik dovoljenja za promet z zdravilom opredelil 33 primerov z uporabo največjega dnevnega odmerka 600 mg.
English: Having assessed the risk minimisation measures proposed by the MAH, the CHMP concluded that given the high risk with buflomedil, notably in patients with advanced vascular disease and/or diabetes and metabolic syndrome, in patients with impaired renal function and in elderly patients, no adequate or sufficient measures could be identified to reduce the risks associated with buflomedil to an acceptable level.
Slovenian: Po ocenitvi ukrepov za zmanjšanje tveganj, ki jih je predlagal imetnik dovoljenja za promet z zdravilom, je CHMP zaključil, da ustreznih ali zadostnih ukrepov za zmanjšanje tveganj, povezanih z buflomedilom, na sprejemljivo raven, zlasti pri bolnikih z napredovalo žilno boleznijo in/ali sladkorno boleznijo in presnovnim sindromom pri bolnikih z okvarjenim delovanjem ledvic in pri starejših bolnikih, ni bilo mogoče opredeliti.
English: Having assessed the totality of the risk minimisation measures proposed by the MAH, the CHMP concluded that given the high risk with buflomedil, notably in patients with impaired renal function and in elderly patients, no measures could be identified to reduce the risks associated with buflomedil to an acceptable level.
Slovenian: Po ocenitvi vseh ukrepov za zmanjšanje tveganj, ki jih je predlagal imetnik dovoljenja za promet z zdravilom, je CHMP zaključil, da noben od ukrepov za zmanjšanje tveganj, povezanih z buflomedilom, na sprejemljivo raven, zlasti pri bolnikih z okvarjenim delovanjem ledvic in pri starejših bolnikih, ni zadosten.
English: (Invente d) name
Slovenian: (Izmiљlje no) ime
English: MA (EU) Number
Slovenian: Љtevilka (EU) dovoljenja za promet
English: Strength Pharmaceuti cal form
Slovenian: Farmacevtska oblika
English: Route of administratio n
Slovenian: Pot uporabe Stična ovojnina
English: This procedure ended on 28 November 2006.
Slovenian: Ta postopek se je zaključil 28. novembra 2006.
English: Enurace 50 Tablets
Slovenian: Enurace 50 Tablete
English: This conclusion is accepted.
Slovenian: Tak zaključek je bil sprejet.
English: Schepenveld 41 3891 ZK Zeewolde The Netherlands fs@ace-pharm.nl
Slovenian: Schepenveld 41 3891 ZK Zeewolde Nizozemska fs@ace-pharm.nl
English: The Netherlands, Belgium, Germany, France, Italy, Spain and the United Kingdom.
Slovenian: Nizozemska, Belgija, Nemčija, Francija, Italija, Španija in Združeno kraljestvo
English: Considering safety, the product seems not to create a considerable risk to young and healthy animals.
Slovenian: Kar se tiče varnosti, ni videti, da bi zdravilo povzročilo pomembno tveganje za mlade in zdrave živali.
English: Since 1998 post-marketing studies have been performed as well as regular monitoring of adverse effects by FAQ system.
Slovenian: Od leta 1998 so se izvajale postmarketinške raziskave in redno spremljanje neželenih učinkov s sistemom FAQ.
English: Indeed, treatment is not successful in all animals, but the level of efficacy is such that there is an advantage in treatment.
Slovenian: Zdravljenje torej ni uspešno pri vseh živalih, vendar je raven učinkovitosti takšna, da zdravljenje prinaša prednosti.
English: Enurace 50 was first authorised in The Netherlands on 15 September 2000.
Slovenian: Dovoljenje za promet z zdravilom Enurace 50 je bilo najprej izdano na Nizozemskem 15. septembra 2000.
English: Enurace has been officially authorised since 2000 (since 1995 available in the Netherlands).
Slovenian: Dovoljenje za promet z zdravilom Enurace je bilo izdano leta 2000 (od leta 1995 je na voljo na Nizozemskem).
English: At Day 90 of the MRP, 27 September 2006, France and Italy could not agree to the granting of a marketing authorization as they consider there are potentially serious risks for animal health.
Slovenian: Francija in Italija se na 90. dan postopka medsebojnega priznavanja, 27. septembra 2006, nista strinjali z odobritvijo dovoljenja za promet, saj sta menili, da obstajajo potencialno resna tveganja za zdravje živali.
English: However, in Europe ovariohysterectomy is most frequently performed in middle aged and old bitches.
Slovenian: Vendar se v Evropi ovariohisterektomija najpogosteje opravlja pri psicah srednjih let ali starih psicah.
English: A Mutual Recognition Procedure started on 29 June 2006 with The Netherlands as Reference Member State and Belgium, Germany, Spain, France, Italy and the United Kingdom as Concerned Member States.
Slovenian: Dne 29. junija 2006 se je začel postopek medsebojnega priznavanja (MRP), pri čemer je bila Nizozemska referenčna država članica, Belgija, Nemčija, Španija, Francija, Italija, in Združeno kraljestvo pa zadevne države članice.
English: CMD(v) could not reach an agreement by day 60 of this procedure, as France and Italy maintained their concerns.
Slovenian: V CMD(v) do 60. dne tega postopka ni bilo doseženo soglasje, saj sta Francija in Italija vztrajala pri svojih zadržkih.
English: Possible risk connected with the use of ephedrine in this group of animals can be reduced by appropriate management measures.
Slovenian: Možna tveganja zaradi uporabe efedrina v tej skupini živali lahko zmanjšamo z ustreznimi ukrepi pri obravnavi.
English: These figures seem highly convincing when compared to the 20 % placebo treated animals that became continent in study ACE129801.
Slovenian: Te številke so zelo prepričljive v primerjavi z 20 % živalih, ki so dobivale placebo in postale kontinenčne v raziskavi ACE129801.
English: The raw outcome shows good effect in both test and control groups (87% vs 85.5%), an effect that might be somewhat higher in treatment naïve animals (93.7% vs 88.9%).
Slovenian: Neobdelani podatki o rezultatih kažejo dober učinek v testni in kontrolni skupini (87 % proti 85,5 %), ki pa je še boljši pri zdravljenju prej nezdravljenih živali (93,7 % napram 88,9 %).
English: However, the study where Enurace 50 is compared to Propaline (ACE129802) is convincing although a non-inferiority analysis has not been performed.
Slovenian: Vendar je raziskava, kjer so primerjali zdravilo Enurace 50 z zdravilom Propaline (ACE129802) prepričljiva, čeprav analiza neinferiornosti ni bila opravljena.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendment:
Slovenian: Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine z naslednjo dopolnitvijo:
English: The Marketing Authorisation Holder should provide all supporting data (preclinical and clinical documentation, including the expert reports, efficacy and tolerance studies conducted), to justify a positive benefit-risk ratio for the treated animal.
Slovenian: Imetnik dovoljenja za promet z zdravilom (MAH) mora predložiti vse podporne podatke (predklinično in klinično dokumentacijo, vključno s strokovnimi poročili, opravljenimi raziskavami učinkovitosti in tolerance) za utemeljitev pozitivnega razmerja med koristmi/tveganji za zdravljeno žival.
English: 3 Conclusion and Recommendation
Slovenian: Zaključki in priporočila
English: The CVMP has concluded that the risk/benefit for this product is favourable.
Slovenian: CVMP meni, da je razmerje med tveganji koristmi za to zdravilo ugodno.
English: Taking into account that urinary incontinence may occur even several years after the operation it can be suspected that Enurace would be used mostly in older animals, more frequently suffering form cardiovascular, liver, renal and other diseases.
Slovenian: Ob upoštevanju, da se urinska inkontinenca lahko pojavi celo več let po operaciji, lahko sklepamo, da bi se zdravilo Enurace uporabljalo večinoma pri starejših živalih, ki imajo pogosteje srčno-žilne, jetrne, ledvične in druge bolezni.
English: Proposed dose of 1 - 3 mg Ephedrine HCl /kg/day, divided in two oral doses is effective and safe, but some animals may need a higher dose, which is associated with individual variation in the response to ephedrine.
Slovenian: Predlagani odmerek 1 - 3 mg efedrina HCl/kg/dan, ki ga razdelimo v dva peroralna odmerka, je učinkovit in varen, vendar nekatere živali potrebujejo višji odmerek, ki je povezan z individualno variacijo odziva na efedrin.
English: The application was made in accordance with Article 12.3 of Directive 2001/82/EC as a stand alone application.
Slovenian: Vloga je bila predložena v skladu s členom 12(3) Direktive 2001/82/ES kot samostojna vloga.
English: At the recommended dose level, which according to the suggested SPC should be individually adjusted, safety is ensured to a reasonable level.
Slovenian: Pri priporočenem odmerku, ki ga je treba skladno s predlogom Povzetka glavnih značilnosti zdravila individualno prilagoditi, je varnost zagotovljena do primerne ravni.
English: Although the influence of age was not reflected in the tolerance studies, it was taken into account in the efficacy and post- marketing studies.
Slovenian: V študijah tolerance niso preverjali vpliva starosti živali, upoštevali pa so ga v študijah učinkovitosti in postmarketinških raziskavah.
English: A starting dose of 2 mg Ephedrine HCl per kg of bodyweight per day, divided in two oral doses is recommended.
Slovenian: Priporočeni začetni odmerek je 2 mg efedrina HCl na kg telesne mase dnevno, razdeljen v dva peroralna odmerka.
English: Strength Animal species
Slovenian: Jakost Živalsk a vrsta
English: Regarding cardiac dysfunction, this was one of the exclusion criteria so the studies give no information on use of the product in animals with such a condition but there is also no data suggesting that the cardiac patients must not be treated with the substance.
Slovenian: Glede srčne disfunkcije Odbor ugotavlja, da je slednja bila eden od izključitvenih kriterijev, zato raziskave niso prinesle podatkov o uporabi zdravila pri živalih s takšnim stanjem, vendar tudi ni podatkov, da srčnih bolnikov ne smemo zdraviti z efedrinom.
English: The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/82/EC as amended for Enurace 50.
Slovenian: CVMP je na seji decembra 2006 za zdravilo Enurace 50 začel napotitveni postopek po členu 33(4) Direktive 2001/82/ES, kakor je bila spremenjena.
English: France considers the risk/benefit analysis unfavourable for the animal when the adverse effects (in very rare cases atrium fibrillation and tachycardia) are weighed against the potential benefits of effective treatment of incontinence.
Slovenian: Francija meni, da je razmerje med tveganji in koristmi neugodno za živali, če tehtamo neželene učinke (atrijska fibrilacija in tahikardija v zelo redkih primerih) in potencialne koristne učinke učinkovitega zdravljenja inkontinence.
English: In response to the questions related to toxicity, the applicant argues that due to the pharmacologic effect of ephedrine and the individual variation in receptor density no safety margin can be determined and increasing doses will be associated to increased intensity and frequency of well known adverse effects.
Slovenian: Vlagatelj na vprašanja o toksičnosti odgovarja z ugotovitvijo, da zaradi farmakološkega učinka efedrina in variacije med posameznimi živalmi glede gostote receptorjev, ni mogoče določiti varnostne meje, višanje odmerka pa bo povezano z intenzivnostjo in pogostostjo dobro poznanih neželenih učinkov.
English: For the reason of very limited treatment options, high risk of euthanasia if treatment fails or is not affordable, ephedrine is a substance of other eventual choice - Propalin instead Enurace and vice versa, considering that sympathicomimetic treatment of urinary incontinence is far better than hormonal treatment (an alternative is surgical therapies as colposuspension, urethropexy and the endoscopic injection of collagen in refractory cases).
Slovenian: Ker je pri urinski inkontinenci zelo malo možnosti za zdravljenje in obstaja veliko tveganje evtanazije, če zdravljenje ne uspe ali ni finančno dostopno, velja zdravilo efedrin kot druga alternativna možnost, tj. zdravilo Propalin namesto zdravila Enurace in obratno, zlasti če upoštevamo, da je simpatikomimetično zdravljenje urinske inkontinence veliko boljše od hormonskega zdravljenja (alternativna možnost so kirurški posegi, kot so kolposuspenzija, uretropeksija in endoskopsko injiciranje kolagena v neodzivnih primerih).
English: Efficacy data are connected to several shortcomings and the amount of data available is sparse.
Slovenian: Podatkov o učinkovitosti je malo in imajo več pomanjkljivosti.
English: There is no doubt that treatment of the dog with Enurace may involve an occurrence of adverse reactions due to peculiar activity of ephedrine.
Slovenian: Zdravljenje psic z zdravilom Enurace nedvomno lahko vključuje pojav neželenih učinkov zaradi posebnosti efedrina.
English: The data provided by the applicant show that Enurace 50 is an effective medicinal product for treatment of urinary incontinence in ovariohysterectomised bitches.
Slovenian: Podatki, ki jih je predložil vlagatelj, kažejo, da je zdravilo Enurace 50 učinkovito zdravilo za zdravljenje urinske inkontinence pri psicah z ovariohisterektomijo.
English: Taking the benefit of the treatment into account and the relatively low level of adverse effects, as it appears from PMS studies, the risk/benefit balance is considered favourable.
Slovenian: Če upoštevamo koristne učinke zdravljenja in relativno nizko pojavnost neželenih učinkov, ki je razvidna iz postmarketinških raziskav, se lahko šteje, da je razmerje med tveganji in koristmi ugodno.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, ŽIVALSKIH VRST, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET
English: The use of human labelled preparations or dosage forms obtained from a compounding pharmacy which contain ephedrine constitute a much more dangerous alternative for treatment of urinary incontinence in dogs if the product with a marketing authorisation and a proved efficacious use in the RMS for many years is not available.
Slovenian: Uporaba pripravkov, označenih za človeka, ali oblik odmerjanja, pridobljenih iz sestavljenih zdravil, ki vsebujejo efedrin, predstavljajo veliko bolj nevarno alternativo za zdravljenje urinske inkontinence pri psih v primeru, če zdravilo z dovoljenjem za promet in dokazano učinkovitostjo v referenčni državi članici več let ne bo dostopno.
English: The dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment.
Slovenian: Pred zdravljenjem z Enurace 50 je treba pozorno preveriti delovanje kardiovaskularnega sistema psa in ga med zdravljenjem periodično nadzorovati.
English: Italy could accept the application with revised wording in the SPC .
Slovenian: Italija bi lahko sprejela vlogo s popravljenim besedilom Povzetka glavnih značilnosti zdravila.
English: With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “the dog's cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Slovenian: Glede srčno-žilnih bolezni je treba poglavje 4.5 Povzetka glavnih značilnosti zdravila dopolniti s stavkom „pred začetkom zdravljenja z zdravilom Enurace 60 je treba natančno določiti funkcionalnost srca in ožilja ter to funkcionalnost redno spremljati v času zdravljenja“.
English: Section 4.5 of the SPC and Section 12 of the Package Leaflet:
Slovenian: poglavje 4.5 v Povzetku glavnih značilnosti zdravila in poglavje 12 Navodila za uporabo:
English: 50 mg Female dogs
Slovenian: 50 mg Psice Samo za peroralno uporabo skupaj s hrano
English: Special precautions for use
Slovenian: 4.5 Posebni previdnostni ukrepi
English: The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) for a 60 day procedure in accordance with Article 33(1) of Directive 2001/82/EC, as amended.
Slovenian: Zadeva je bila skladno s členom 33(1) Direktive 2001/82/ES, kakor je bila spremenjena, napotena na Koordinacijsko skupino za medsebojno priznavanje in decentralizirane postopke CMD(v).
English: Although toxicity data for the target animal may be scarce, the adverse effects connected to ephedrine treatment are well known from human use, and the applicant has provided some post-marketing information regarding the use in dogs.
Slovenian: Čeprav je podatkov o toksičnosti za ciljno žival malo, so neželeni učinki zdravljenja z efedrinom dobro poznani pri ljudeh.
English: Treatment is given in 28-day cycles.
Slovenian: Zdravljenje poteka v 28-dnevnih ciklih.
English: Further information on Empliciti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/empliciti.
Slovenian: Nadaljnje informacije o zdravilu Empliciti so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/empliciti.
English: Empliciti received a marketing authorisation valid throughout the EU on 11 May 2016.
Slovenian: Za zdravilo Empliciti je bilo 11. maja 2016 izdano dovoljenje za promet, veljavno po vsej EU.
English: The European Medicines Agency therefore decided that Empliciti's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Empliciti večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Empliciti?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Empliciti?
English: What is Empliciti and what is it used for?
Slovenian: Kaj je zdravilo Empliciti in za kaj se uporablja?
English: What benefits of Empliciti have been shown in studies?
Slovenian: Kakšne koristi zdravila Empliciti so se pokazale v študijah?
English: It is given once a week for the first 2 cycles and less frequently in subsequent cycles.
Slovenian: V prvih dveh ciklih zdravljenja se daje enkrat na teden, v naslednjih ciklih pa manj pogosto.
English: Other information about Empliciti
Slovenian: Druge informacije o zdravilu Empliciti
English: Why is Empliciti authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Empliciti odobreno v EU?
English: As for all medicines, data on the use of Empliciti are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Empliciti stalno spremljajo.
English: Although side effects, particularly infections, were more common with Empliciti, the risks on the whole appear manageable.
Slovenian: Čeprav so bili neželeni učinki, zlasti okužbe, pri zdravilu Empliciti pogostejši, se zdijo tveganja zdravila v splošnem obvladljiva.
English: Side effects reported with Empliciti are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Empliciti, 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 Empliciti 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 Empliciti upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: An overview of Empliciti and why it is authorised in the EU
Slovenian: Pregled zdravila Empliciti in zakaj je odobreno v EU
English: The dose of Empliciti depends on the patient's weight.
Slovenian: Odmerek zdravila Empliciti je odvisen od bolnikove telesne mase.
English: What are the risks associated with Empliciti?
Slovenian: Kakšna tveganja so povezana z zdravilom Empliciti?