FrancophonIA/ELRC3.0 huggingface dataset:
English: How does Rasagiline Mylan work?
Slovenian: Kako zdravilo Razagilin Mylan deluje?
English: How is Rasagiline Mylan used?
Slovenian: Kako se zdravilo Razagilin Mylan uporablja?
English: Intramuscular use vial (glass)
Slovenian: 100 enot prašek za raztopino za injiciranje intramuskularna uporaba viala (steklena)
English: dextropropoxyphene/ paracetamol/ caffeine
Slovenian: Jakost/ dekstropropoksifen/ paracetamol/ kofein
English: ANNEX III CONDITION FOR THE LIFTING OF THE SUSPENSION
Slovenian: DODATEK III POGOJI ZA PREKLIC UMIKA
English: For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Slovenian: Da bi umik dovoljenj za promet prenehal veljati, bi morali njihovi imetniki nacionalnim pristojnim organom predložiti naslednje:
English: Intramuscular, intravenous use
Slovenian: Intramuskularna uporaba, Intravenska uporaba
English: In addition, in some member states it had been both difficult and time-consuming to collate the relevant data for the purposes of the Article 31 referral, and it would be impractical and, in the medium term, unfeasible to monitor the effectiveness of risk minimization activities in these countries.
Slovenian: Poleg tega je bila v nekaterih državah primerjava ustreznih podatkov za namene napotitve iz člena 31 težka in dolgotrajna, zato bi bilo v teh državah spremljanje učinkovitosti dejavnosti za zmanjšanje tveganja nepraktično in srednjeročno celo neizvedljivo.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA UMIK DOVOLJENJA ZA PROMET Z ZDRAVILOM, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: - The Committee concluded that the risks associated with the use of parenteral dextropropoxyphene medicinal products in the treatment of symptomatic pain outweigh the potential benefit as the efficacy has not been demonstrated.
Slovenian: - Odbor je zaključil, da tveganja, povezana z uporabo zdravil, ki vsebujejo parenteralni dekstropropoksifen pri zdravljenju simptomatske bolečine presegajo morebitne koristi, saj učinkovitost ni bila dokazana.
English: Since the benefit/risk reviews of dextropropoxyphene containing products were carried out in the UK, Sweden, France, and Ireland in 2005 - following which the fixed dose combination product (paracetamol + dextropropoxyphene) was withdrawn from the market in the UK, Sweden, and Ireland - a substantial body of important new safety information has become available.
Slovenian: Odkar so v Združenem kraljestvu, na Švedskem, v Franciji in na Irskem leta 2005 opravili pregled razmerja med koristmi in tveganji zdravil, ki vsebujejo dekstropropoksifen, kar je povzročilo umik zdravil s kombinacijo fiksnih odmerkov (paracetamol + dekstropropoksifen ) s tržišč v Združenem kraljestvu, na Švedskem in Irskem, je bila dana na razpolago obsežna količina pomembnih novih informacij o varnosti.
English: On the basis of evidence of harm from reports of fatal overdose, of divergent safety reviews and previous regulatory action taken in several Member States, the European Commission initiated a referral under Article 31(2) of Directive 2001/83/EC, as amended, to address this public health issue for medicinal products containing dextropropoxyphene and paracetamol, and therefore referred the matter to the CHMP on 30 November 2007.
Slovenian: Na osnovi dokazov o škodljivih učinkih iz poročil o smrtnih izidih zaradi prevelikih odmerkov, različnih varnostnih pregledih in preteklih regulativnih ukrepov, opravljenih v več državah članicah, je Evropska komisija za obravnavo tega vprašanja javnega zdravja sprožila napotitveni postopek po členu 31(2) Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo dekstropropoksifen in paracetamol, in je zato dne 30. novembra 2007 napotila zadevo na CHMP.
English: Dextropropoxyphene containing medicinal products (as single component or combination with paracetamol or paracetamol/caffeine) are used in the symptomatic treatment of pain and are currently authorised in several Member States.
Slovenian: Zdravila, ki vsebujejo dekstropropoksifen (kot edino sestavino ali v kombinaciji s paracetamolom ali paracetamolom in kofeinom) se uporabljajo za simptomatsko zdravljenje bolečine in so trenutno odobrena v več državah članicah.
English: For a single dose of dextropropoxyphene 65 mg in postoperative pain the number needed to treat to benefit for at least 50% pain relief was 7.7 (95% confidence interval 4.6 to 22) when compared with placebo over 4-6 hours.
Slovenian: Za enojni odmerek dekstropropoksifena 65 mg za postoperativno bolečino je bilo število bolnikov, potrebnih za doseganje koristi vsaj 50-odstotnega olajšanja bolečine, 7,7 (95-odstotni interval zaupanja od 4,6 do 22) v primerjavi s placebom v obdobju 4-6 ur.
English: However no consideration was given to the need for national mortality data, and in particular forensic pathology data, to ensure that any risk minimisation measures are working: it is not possible to use routinely-collected (spontaneous) data to assess the effectiveness of the risk minimisation measures, because of the significant under-reporting of even serious adverse events, including death.
Slovenian: Vendar pa se ni upoštevalo, da so potrebni nacionalni podatki o smrtnosti, zlasti forenzični patološki podatki, da bi zagotovili, da ukrepi za zmanjšanje tveganja delujejo: rutinsko zbranih (spontanih) podatkov za ocenjevanje učinkovitosti ukrepov za zmanjšanje tveganja ni mogoče uporabiti, ker so celo resni neželeni učinki, vključno s smrtjo, nezadostno sporočeni.
English: The narrow therapeutic index means that accidental overdose is a real possibility under normal conditions of use, particularly for patients on certain concomitant medications or when combined with even a small amount of alcohol.
Slovenian: Ozek terapevtski indeks pomeni, da je nenamerno preveliko odmerjanje realna možnost v normalnih pogojih uporabe, zlasti pri bolnikih, ki prejemajo določena sočasna zdravljenja ali pri zaužitju že majhne količine alkohola.
English: Although available meta-analyses mostly included single dose studies, these data also provided further insights in the efficacy of the dextropropoxyphene containing medicinal products.
Slovenian: Čeprav so bile v razpoložljive metaanalize večinoma vključene študije enojnih odmerkov, pa ti podatki omogočajo dodaten vpogled v učinkovitost zdravil, ki vsebujejo dekstropropoksifen.
English: Risk Minimisation measures proposed by the MAHs included restriction of the use of the product (i.e. changes in SPC to restrict the population; pack size reduction), modification of the posology (e.g. reduction of posology in elderly population) and addition of further safety warnings (e.g. on concomitant use with alcohol, dependence and tolerance, combination with other central acting analgesics and overdose in children).
Slovenian: Ukrepi za zmanjšanje tveganja, ki jih je predlagal imetnik dovoljenja za promet z zdravilom so omejitev uporabe zdravila (tj. sprememba v povzetku glavnih značilnosti zdravila za omejitev populacije, manjša velikost pakiranj), sprememba odmerjanja (tj. manjše odmerjanje pri starejši populaciji) ter dodatna varnostna opozorila (npr. o sočasni uporabi alkohola, odvisnosti in toleranci, kombinaciji z drugimi osrednje delujočimi analgetiki ter prevelikem odmerjanju pri otrocih).
English: Similarly in Ireland, analysis in 2009 of further data from the Alcohol and Drug Research Unit of the Health Research Board revealed significant under-reporting of deaths associated with dextropropoxyphene-containing products - indicating fatality rates fifteen-fold higher than previously reported.
Slovenian: Podobno je na Irskem leta 2009 analiza dodatnih podatkov iz Enote za raziskave alkohola in drog odbora za zdravstvene raziskave razkrila precejšnje število smrti, povezanih z uporabo zdravil, ki vsebujejo dekstropropoksifen, ki niso bile sporočene, kar kaže na petnajstkrat višjo stopnjo smrtnosti, kot je bila sporočena.
English: In addition, the CHMP considered other known risks associated with the use of parenteral opioids such as the risk of abuse and dependence.
Slovenian: Poleg tega je CHMP upošteval druga znana tveganja, povezana z uporabo parenteralnih opioidov, kot sta tveganje zlorabe in odvisnost;
English: The availability of a parenteral formulation might be viewed as providing a further therapeutic option, since it would arguably reduce the risk of an accidental overdose (by the patient taking more, because of lack of efficacy) and of intentional overdose (depending on where supplies were held).
Slovenian: Razpoložljivost parenteralne formulacije se lahko vzame kot ponudba dodatne terapevtske možnosti, saj bi mogoče zmanjšala tveganje nenamernega prevelikega odmerka (da bi bolnik vzel več zdravila zaradi pomanjkanja učinkovitosti) in namernega prevelikega odmerka (odvisno od mesta hrambe zalog).
English: However, the CHMP took note of the narrow therapeutic index of dextropropoxyphen containing products.
Slovenian: Vendar pa je CHMP upošteval ozek terapevtski indeks zdravil, ki vsebujejo dekstropropoksifen.
English: Therefore the CHMP recommended the withdrawal of all Marketing Authorisations for medicinal products containing dextropropoxyphene.
Slovenian: Zato je priporočil umik vseh dovoljenj za promet z zdravili, ki vsebujejo dekstropropoksifen.
English: In view of the complex context in which cases of fatal overdose occurred under normal conditions of use and in view of the narrow therapeutic index and the potential for rapid death, the CHMP was of the opinion that the above proposed risk minimisation activities of narrowing the indication, reducing the pack sizes and/or introducing further safety warnings and contraindications (including those beyond the Product Information) would not be able to reduce the risks to an acceptable level.
Slovenian: Zaradi zapletenega ozadja primerov prevelikega odmerjanja s smrtnim izidom ob normalnih pogojih uporabe ter ozkega terapevtskega indeksa in možnosti hitre smrti je CHMP menil, da zgoraj predlagani ukrepi zmanjšanja tveganja, tj. zoženje indikacije, zmanjšanje velikosti pakiranja in/ali uvedba dodatnih varnostnih opozoril ter kontraindikacij (vključno s takimi, ki niso naštete v informacijah o zdravilu) ne bi zmanjšali tveganja na sprejemljivo raven.
English: On the basis of the available data sources, the CHMP was of the opinion that spontaneous reporting was significantly underestimating the number of reported deaths associated with dextropropoxyphene.
Slovenian: CHMP je na osnovi razpoložljivih virov podatkov menil, da spontana poročila bistveno podcenjujejo število sporočenih smrti, povezanih z dekstropropoksifenom.
English: A substantial proportion of the fatal overdoses are accidental - occurring under normal conditions of use, for the licensed indication of painand there is a significant public health impact in relation to these cases alone.
Slovenian: Precejšen delež primerov prevelikega odmerjanja s smrtnim izidom je nenameren in se zgodi ob normalnih pogojih uporabe za odobreno indikacijo bolečine, vendar je vpliv na javno zdravje že samo v zvezi s temi primeri pomemben.
English: Based on the limited efficacy and the significant risk of fatal overdose (in particular accidental overdose), the CHMP was of the opinion that the benefit/risk balance of dextropropoxyphene containing medicinal products was negative.
Slovenian: Na osnovi omejene učinkovitosti in pomembnega tveganja prevelikega odmerjanja s smrtnim izidom (zlasti nenamernega) je CHMP menil, da je razmerje med koristmi in tveganji zaradi zdravil z dekstropropoksifenom negativno.
English: Although spontaneous reporting suggested that the safety signal concerning the overdose was not significant, other more complete data, particularly from forensic centres and national mortality statistics confirmed that the risk of accidental fatal overdose under normal conditions of use associated with dextropropoxyphene containing products is of major concern, mainly due to their narrow therapeutic index and high case fatality.
Slovenian: Čeprav so spontana poročila kazala, da varnostni signal v zvezi s prevelikim odmerjanjem ni pomemben, so drugi, popolnejši podatki, zlasti iz forenzičnih centrov in nacionalnih statistik umrljivosti, potrdili, da je tveganje nenamernega prevelikega odmerka s smrtnim izidom ob normalnih pogojih uporabe, povezano z zdravili z dekstropropoksifenom, poglaviten zadržek, zlasti zaradi ozkega terapevtskega indeksa in visoke smrtnosti ob uporabi teh zdravil.
English: In particular, more comprehensive mortality data at a national level from France, notably forensic toxicology results, provided evidence of a significantly greater number of deaths associated with the use of dextropropoxyphene-containing products than had previously been estimated.
Slovenian: Zlasti iz Francije so obsežni podatki o smrtnosti na nacionalni ravni, in sicer pomembni forenzični toksikološki rezultati, zagotovili dokaz o znatno večjem številu smrtnih primerov, povezanih z uporabo zdravil, ki vsebujejo dekstropropoksifen, kot so domnevali prej.
English: After considering the CHMP's major concerns over the toxicity of dextropropoxyphene, given its narrow therapeutic index and its adverse effects on the cardio - respiratory system as well as the lack of information in relation to the use of single component dextropropoxyphene medicinal products, the European Commission agreed on 31 March 2009 to the extension of the scope of the referral to also include authorised medicinal products containing only dextropropoxyphene.
Slovenian: Po obravnavi poglavitnih zadržkov CHMP glede toksičnosti dekstropropoksifena in ob upoštevanju njegovega ozkega terapevtskega indeksa ter njegovih neželenih učinkov na srčno-dihalni sistem ter pomanjkanja podatkov o uporabi zdravil z dekstropropoksifenom kot edino sestavino, se je Evropska komisija dne 31. marca 2009 odločila razširiti obseg napotitvenega postopka z vključitvijo odobrenih zdravil, ki vsebujejo le dekstropropoksifen.
English: However, the CHMP considered that parenteral opioids carry further significant risks in themselves, such as abuse/dependence and diversion which are also of major concern.
Slovenian: Vendar je CHMP menil, da parenteralni opioidi sami po sebi pomenijo precejšnja dodatna tveganja, kot so zloraba/odvisnost in rekreativna uporaba, ki so tudi poglaviten razlog za zaskrbljenost.
English: Also, research in the UK demonstrated the benefits of the withdrawal of dextropropoxyphene from the market - with clear evidence of a fall in number of deaths associated with dextropropoxyphene, but without any rise in mortality from poisoning with other common analgesics.
Slovenian: Raziskava v Združenem kraljestvu je pokazala koristi umika dekstropropoksifena s trga: zmanjšanje števila smrti, povezanih z dekstropropoksifenom, je bilo jasno razvidno, hkrati pa število smrtnih primerov zaradi zastrupitev z drugimi običajnimi analgetiki ni naraslo.
English: Apart from the strengthened warnings, and more extensive contra-indications, proposed by several MAHs, the other proposals for changes in the SPCs and PLs - for example, in relation to indication - reflected the existing variations across Europe and were often not internally consistent.
Slovenian: Poleg okrepljenih opozoril in podrobnejših kontraindikacij, ki so jih predlagali nekateri imetniki dovoljenja za promet, so bile iz drugih predlaganih sprememb povzetka glavnih značilnosti zdravila in navodila za uporabo, na primer v zvezi z indikacijo, razvidne razlike, ki obstajajo po Evropi, ki pogosto niti notranje niso bile dosledne.
English: Though a parenteral formulation of dextropropoxyphene might be viewed as providing a further therapeutic option, parenteral opioids carry further significant risks in themselves, such as abuse/dependence and diversion, which would appear difficult to justify in this instance given the lack of evidence of efficacy.
Slovenian: Čeprav lahko parenteralno formulacijo dekstropropoksifena jemljemo kot ponudbo dodatne terapevtske možnosti, parenteralni opioidi sami po sebi pomenijo precejšnja dodatna tveganja, kot so zloraba/odvisnost in rekreativna uporaba, kar je v tem primeru težko utemeljiti, če upoštevamo pomanjkanje dokazov o učinkovitosti.
English: - Evidence of a patient population in which the benefit-risk balance of parenteral dextropropoxyphene medicinal products is positive.
Slovenian: - dokaz o bolnikih, pri katerih je razmerje med koristmi in tveganji pri uporabi zdravila s parenteralnim dekstropropoksifenom pozitivno.
English: The Committee noted that this risk is limited for the parenteral dextropropoxyphene medicinal products, given the administration under hospital setting (given by healthcare professionals) and the classification of these medicinal products as narcotic prescription (in the Member State where the product is authorised).
Slovenian: Odbor je menil, da je za zdravila, ki vsebujejo parenteralni dekstropropoksifen, omejeno, saj se običajno prejema v bolnišnici (in ga daje usposobljeno zdravstveno osebje), poleg tega so ta zdravila razvrščena kot narkotiki, ki se dobijo na recept (v državi članici, kjer je zdravilo odobreno).
English: For the suspension to be lifted, the Marketing Authorisation Holders would need to provide evidence of a patient population in which the benefit-risk balance of parenteral dextropropoxyphene medicinal products is positive.
Slovenian: Da bi umik dovoljenj za promet prenehal veljati, bi morali njihovi imetniki predložiti dokaze o bolnikih, pri katerih je razmerje med koristmi in tveganji pri uporabi zdravil s parenteralnim dekstropropoksifenom pozitivno.
English: After reviewing all the available data, the CHMP considered that the different figures provided by the data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels.
Slovenian: CHMP je po pregledu vseh razpoložljivih podatkov menil, da so različne številke iz virov podatkov (spontanih poročil, forenzičnih centrov, centrov za zastrupitve, nacionalnih statistik umrljivosti) skupno pokazale precejšnje število smrti, pri katerih je bil dekstropropoksifen prisoten v toksičnih ravneh.
English: Therefore, the CHMP concluded by majority that the benefit-risk balance of dextropropoxyphene containing medicinal products is negative and that its Opinion of 25 June 2009 should not be revised for oral/rectal dextropropoxyphene containing medicinal products and recommended the withdrawal of the Marketing Authorisations to be effective within the next 15 months of the Commission Decision in order to allow switching patients to safer alternatives, considering the extensive clinical use of dextropropoxyphene containing medicinal products and the wide patient exposure in some Member States.
Slovenian: Zato je CHMP z večino glasov zaključil, da je razmerje med koristmi in tveganji pri zdravilih, ki vsebujejo dekstroproposkifen, negativno, da mnenja o zdravilih, ki vsebujejo dekstropropoksifen za peroralno/rektalno uporabo z dne 25. junija 2009 ni potrebno ponovno pregledati in je priporočil, da se dovoljenja za promet z zdravilom umaknejo v 15 mesecih od odločbe Komisije, da se glede na obsežno klinično uporabo zdravil, ki vsebujejo dekstropropoksifen in velikega števila bolnikov, ki so temu zdravilu izpostavljeni v državah članicah, bolnikom omogoči prehod na varnejša alternativna zdravila.
English: Whilst there is a risk of fatal overdose, the CHMP considered that it is limited for the parenteral dextropropoxyphene medicinal products, given the administration under hospital setting (given by healthcare professionals) and the classification of these medicinal products as narcotic prescription (in the Member State where the product is authorised) and the lack of evidence of fatal overdose particularly of accidental overdose.
Slovenian: Čeprav obstaja verjetnost prevelikega odmerjanja s smrtnim izidom, je CHMP menil, da je omejena le na zdravila, ki vsebujejo parenteralni dekstropropoksifen, saj se zdravilo običajno prejema v bolnišnici (in ga daje usposobljeno zdravstveno osebje), ta zdravila pa so razvrščena kot narkotiki, ki se dobijo na recept (v državi članici, kjer je zdravilo odobreno), in ker ni dovolj dokazov o smrtnih izidih, zlasti pri nenamernem prevelikem odmerjanju.
English: Having considered the detailed grounds for re-examination provided by the group of MAHs in writing and in an oral explanation, the CHMP considered that the design of the proposed clinical study to demonstrate the superior efficacy for combination of dextropropoxyphene and paracetamol versus paracetamol alone was flawed, and even a well-designed study would not change the benefit-risk balance of the dextropropoxyphene medicinal products in view of the narrow therapeutic index.
Slovenian: Odbor CHMP je po proučitvi podrobnih razlogov za ponovno presojo, ki so jih pisno in z ustno razlago navedli imetniki dovoljenja za promet, menil, da je bila zasnova predlagane klinične študije, ki bi dokazala večjo učinkovitost kombinacije dektropropoksifena in paracetamola v primerjavi s paracetamolom samim, pomankljiva, in da tudi dobro zasnovana klinična študija ne bi spremenila razmerja med koristmi in tveganji pri zdravilih, ki vsebujejo dekstropropoksifen, glede na njihov ozek terapevtski indeks.
English: However, the key safety concern with dextropropoxyphene is that it has a very narrow therapeutic index under normal conditions of use: following overdose, cardiac arrhythmias (which cannot be reversed using naloxone) and opioid side effects (such as respiratory depression) are rapid in onset and often fatal - there is evidence that the case fatality rate is higher than, for example, for tricyclic antidepressants.
Slovenian: Vendar pa je z vidika varnosti največja skrb, ki jo povzroča dekstropropoksifen ta, da ima v normalnih pogojih uporabe zelo ozek terapevtski indeks: preveliki odmerki, srčne aritmije (ki jih ni mogoče ublažiti z naloksonom) in neželeni učinki opioidov (kot je respiratorna depresija) nastopijo hitro in so pogosto usodni.
English: The CHMP also considered that data collected from national poison centres have limitations in this situation as dextropropoxyphene can cause death extremely rapidly (in under an hour); if a patient dies before reaching medical attention, the poisons centre is unlikely to be contacted.
Slovenian: CHMP je menil, da so podatki, zbrani iz nacionalnih centrov za zastrupitve, v tem primeru omejeni, saj lahko dekstropropoksifen povzroči smrt zelo hitro (v roku ene ure).
English: Because of this, the most reliable data come from forensic analysis and national mortality statistics, and complete review of the fatal overdoses associated with dextropropoxyphene (alone and in combination with paracetamol/caffeine)
Slovenian: Zaradi tega najbolj zanesljivi podatki izhajajo iz forenzičnih analiz in nacionalnih statistik umrljivosti, celoten pregled primerov prevelikih odmerkov s smrtnim izidom, povezanih z dekstropropoksifenom (samim ali v kombinaciji s paracetamolom/kofeinom), pa podpira poglavitni zadržek, ki zadeva smrtno toksičnost zdravil, ki vsebujejo dekstropropoksifen ob normalnih pogojih uporabe zaradi njegovega ozkega terapevtskega indeksa.