FrancophonIA/ELRC3.0 huggingface dataset:
English: Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Slovenian: V povezavi z jemanjem sildenafila in drugih zaviralcev PDE5 so spontano in med opazovalno študijo poročali o primerih nearteritične anteriorne ishemične optične nevropatije, redke bolezni (glejte poglavje 4.8).V primeru kakršnekoli nenadne okvare vida je treba zdravljenje nemudoma prekiniti ter razmisliti o alternativnem zdravljenju (glejte poglavje 4.3).
English: Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors.
Slovenian: V povezavi z jemanjem sildenafila in drugih zaviralcev PDE5 so spontano poročali o primerih okvar vida.
English: Recent history of stroke or myocardial infarction, Severe hypotension (blood pressure <90/50 mmHg) at initiation.
Slovenian: Ker varnost sildenafila ni raziskana v naslednjih podskupinah bolnikov, je uporaba sildenafila pri leteh kontraindicirana: - s hudo okvaro jeter, - z anamnezo o nedavni možganski kapi ali miokardnem infarktu, - s hudo hipotenzijo (krvni tlak < 90/50 mmHg) ob uvedbi.
English: Hepatic impairment
Slovenian: dezmetilnega presnovka.
English: Higher than recommended doses should not be used in paediatric patients with PAH (see also sections 4.4 and 5.1).
Slovenian: Pri pediatričnih bolnikih s PAH se ne sme uporabljati odmerkov, večjih od priporočenih (glejte tudi poglavji 4.4 in
English: In volunteers with severe renal impairment (creatinine clearance <30 ml/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
Slovenian: Zaradi tega se je v primerjavi s prostovoljci brez okvare ledvic enake starosti AUC povečala za 100 % in Cmax za 88 %.
English: OTHER
Slovenian: Accord
English: Tablet core:
Slovenian: Laboratori Fundació DAU
English: Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity.
Slovenian: in III. funkcijskem razredu po razvrstitvi Svetovne zdravstvene organizacije (SZO) za izboljšanje sposobnosti za telesno obremenitev.
English: Musculoskeletal and connective tissue disorders
Slovenian: Antagonisti adrenergičnih receptorjev alfa
English: Tabulated list of adverse reactions
Slovenian: Preglednica neželenih učinkov
English: Not known sudden hearing loss
Slovenian: Neželeni učinek neznana izpuščaj
English: However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
Slovenian: Podatkov o sildenafilu pri bolnikih s pljučno arterijsko hipertenzijo, povezano s pljučno venookluzivno boleznijo, ni. So pa pri uporabi pri takšnih bolnikih poročali o primerih smrtno nevarnega pljučnega edema ob uporabi vazodilatatorjev (predvsem prostaciklina).
English: sildenafil 20 mg, sildenafil 40 mg or sildenafil 80 mg, three times a day.
Slovenian: 8 mg) sočasno s sildenafilom (25 mg, 50 mg oz. 100 mg).
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Slovenian: Številka EU Izmišljeno ime Jakost
English: (PAOD Stage II)
Slovenian: (PAOD stadij II);
English: (excluding Alzheimer's disease and other dementia)
Slovenian: (izključujoč Alzheimerjevo bolezen in druge oblike demence);
English: Néphrologie Vol. 24 n° 4 2003, pp. 173-180).
Slovenian: Néphrologie Vol. 24 n° 4 2003, str. 173-180).
English: Available data is in fact indicative of such causal relationship.
Slovenian: Razpoložljivi podatki pravzaprav kažejo na tako vzročno povezavo.
English: Clinical safety
Slovenian: Klinična varnost
English: The relevance of clinical endpoints is questionable.
Slovenian: Pomembnost kliničnih opazovanih dogodkov je vprašljiva.
English: Although some of the proposed measures could help the early identification of patients with fibrosis, it may be too late as these reactions are sometimes irreversible.
Slovenian: Čeprav bi lahko nekateri predlagani ukrepi pomagali pri zgodnjem odkrivanju bolnikov s fibrozo, bi bilo to lahko prepozno, saj so te reakcije včasih ireverzibilne.
English: Overall summary of the scientific evaluation of dihydroergotamine containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo dihidroergotamin (glejte Prilogo I)
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC the CHMP recommends:
Slovenian: zato odbor CHMP skladno s členom 116 Direktive 2001/83/ES priporoča:
English: The number of patients included was small and the duration of treatment was too short.
Slovenian: Število vključenih bolnikov je bilo majhno, trajanje zdravljenja pa prekratko.
English: Some of them assessed the injection route or doses higher than recommended (up to 42mg daily, instead of 10mg daily).
Slovenian: Nekatere od njih so ocenjevale injiciranje ali odmerek, večji od priporočenih (do 42 mg na dan namesto 10 mg na dan).
English: Efficacy was assessed by comparing absolute blood pressure measurements after treatment rather than comparing the differences between supine and standing position which was not considered acceptable.
Slovenian: Učinkovitost so ocenili s primerjavo meritev absolutnega krvnega tlaka po zdravljenju in ne s primerjanjem razlike med ležečim ter stoječim položajem, kar ni bilo sprejemljivo.
English: It has long been used in the treatment of migraine on the grounds of its vasoconstrictor activity, which is milder than that of ergotamine.
Slovenian: Že dolgo se uporablja za zdravljenje migrene zaradi svoje vazokonstriktorne dejavnosti, ki je blažja kot pri ergotaminu.
English: The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergotamine.
Slovenian: CHPM je upošteval vse razpoložljive podatke glede varnosti in učinkovitosti dihidroergotamina.
English: • The Committee considered that a potential causal association between fibrotic reactions or ergotism and oral dihydroergotamine cannot be excluded.
Slovenian: • odbor je menil, da morebitne vzročne povezave med fibrotičnimi reakcijami ali ergotizmom in peroralnim dihidroergotaminom ni mogoče izključiti.
English: Patient population was heterogeneous, or patients with hypotension induced by treatment with psychotropic drugs.
Slovenian: Populacija bolnikov je bila heterogena ali pa so imeli bolniki hipotenzijo, ki jo je povzročilo zdravljenje s psihotropnimi zdravili.
English: Therefore, the group was of the opinion that based on the available evidence there is no need for this substance as there is no clear subset of patients that would benefit from it.
Slovenian: Skupina je zato menila, da glede na razpoložljive dokaze ni potrebe po tej učinkovini, saj ni nobene jasne podskupine bolnikov, ki bi jim koristila.
English: • Fibrosis is mentioned in several current European Summaries of Product Characteristics (SmPCs) and expected reactions are often under-reported
Slovenian: • je fibroza omenjena v mnogih trenutnih evropskih povzetkih glavnih značilnosti zdravila, pričakovane reakcije pa so pogosto preredko poročane;
English: On 18 January 2012, France triggered a referral under Article 31 of Directive 2001/83/EC for the following ergot derivatives containing medicinal products: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine and nicergoline.
Slovenian: Francija je 18. januarja 2012 sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES za naslednja zdravila, ki vsebujejo derivate ergot-alkaloidov: dihidroergokriptin/kofein, dihidroergokristin, dihidroergotamin, dihidroergotoksin in nicergolin.
English: The number of patients included was small and the duration of treatment was too short and the clinical efficacy parameters used are not in line with the European Guidelines on clinical investigation of medicinal products for the treatment of migraine.
Slovenian: Število vključenih bolnikov je bilo majhno, trajanje zdravljenja prekratko, uporabljeni parametri za klinično učinkovitost pa niso bili skladni z evropskimi smernicami za klinično raziskovanje zdravil za zdravljenje migrene.
English: The design of this study was considered acceptable by the CHMP (i.e. controlled, randomised, double-blind) but the size of the study was considered small (n=58).
Slovenian: Odbor CHMP je menil, da je načrt te študije sprejemljiv (tj. nadzorovana, randomizirana, dvojno slepa), vendar pa je menil, da je bila velikost študije majhna (n = 58).
English: In the reported cases, dihydroergotamine is mostly indicated for migraine or headache (30 patients) and used with the recommended daily dosage.
Slovenian: Pri poročanih primerih je dihidroergotamin večinoma indiciran za migreno ali glavobol (30 bolnikov) in se je uporabljal v priporočenem dnevnem odmerku.
English: However, more than half of the cases of ergotism reported have been described out of a context of overdose or without the use of a contraindicated drug.
Slovenian: Vendar pa je bila več kot polovica poročanih primerov ergotizma opisana zunaj sklopa prevelikega odmerjanja ali brez uporabe kontraindiciranega zdravila.
English: For the indication “symptomatic treatment of veno-lymphatic insufficiency” very few studies have been conducted.
Slovenian: Za indikacijo „simptomatsko zdravljene veno-limfatične insuficience“ je bilo opraviljenih zelo malo študij.
English: This reaction occurred in young patients (mean age among cases reported: 41 years-old), with a short time to onset after dihydroergotamine initiation (less than 2 months, mean: 2 days).
Slovenian: Ta reakcija se je pojavila pri mladih bolnikih (povprečna starost pri poročanih primerih: 41 let), in sicer kmalu po uvedbi dihidroergotamina (manj kot 2 meseca, povprečje: 2 dneva).
English: The studies presented are old and of poor methodological quality: uncontrolled, open designed, with a low number of patients (n=12 in Wenzel, 1989, the most recent study).
Slovenian: Predstavljene študije so stare, kakovost njihove metodologije pa je slaba: nenadzorovane, odprtega načrta, z majhnim številom bolnikov (n = 12 v najnovejši študiji Wenzel 1989).
English: • The Committee considered the overall submitted data provided by the MAHs and the outcome of the scientific advisory group.
Slovenian: • odbor je upošteval celotne predložene podatke, ki so jih predložili imetniki dovoljenj za promet z zdravilom, in ugotovitve znanstveno svetovalne skupine;
English: A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Slovenian: Če je bilo mogoče, so predložili pregled vseh drugih razpoložljivih podatkov (tj. podatkov iz literature, predkliničnih podatkov in drugih kliničnih podatkov, vključno z epidemiološkimi študijami), primernih za oceno tveganja fibroze.
English: These included restricting the therapeutic indications, recommending close monitoring of patients and the issuing of a DHPC.
Slovenian: Ti so vključevali omejitev terapevtskih indikacij, priporočila za skrbno spremljanje bolnikov in izdajo neposrednega obvestila zdravstvenim delavcem.
English: Dihydroergotamine mesilate (dihydroergotamine - DHE) is a semi-synthetic derivative of ergotamine.
Slovenian: Dihidroergotaminijev mesilat (dihidroergotamin - DHE) je polsintetični derivat ergotamina.
English: As expected, fibrosis occurred mostly in female patients (68%) after long time of treatment with dihydroergotamine (9.1 years on average) and the most frequent type of fibrosis reaction reported was retroperitoneal (36%), followed by cardiac (30%) and pleural (18%).
Slovenian: Kot je bilo pričakovati, se je fibroza večinoma pojavila pri bolnicah (68 %) po dolgotrajnem zdravljenju z dihidroergotaminom (povprečno 9,1 leta), najpogostejše vrste poročanih fibrotičnih reakcij pa so bile retroperitonealne (36 %), srčne (30 %) in plevralne (18 %).
English: The Committee therefore pointed out that the proposed measures are insufficient to avoid that some patients develop fibrosis and ergotism during treatment.
Slovenian: Odbor je zato izpostavil, da predlagani ukrepi niso zadostni, da bi med zdravljenjem preprečili razvoj fibroze in ergotizma pri nekaterih bolnikih.
English: Under-notification can be suspected given that:
Slovenian: Sum na preredko poročanje je prisoten, saj:
English: Therefore, the group was of the opinion that there is not a clearly defined population, which unsatisfactorily responds to standard migraine prophylaxis treatment, where there is a therapeutic need for this substance as alternative/last line treatment.
Slovenian: Skupina je zato zaključila, da ni jasno opredeljene populacije, ki se nezadostno odzove na standardno preprečevanje migrene, kadar obstaja terapevtska potrebna po uporabi te učinkovine kot alternativnega/zadnjega zdravljenja.
English: • The Committee is of the opinion that the evidence for clinically significant efficacy of oral dihydroergotamine in the currently assessed indications is very limited, and therefore the potential benefit for patients in these indications is outweighed by the above identified risk.
Slovenian: • odbor meni, da so dokazi o klinično pomembni učinkovitosti peroralnega dihidroergotamina v zvezi s trenutno odobrenimi indikacijami izredno omejeni, zato je zgoraj omenjeno tveganje večje od morebitne koristi za bolnike v zvezi s temi indikacijami;
English: In addition, patients were included if they displayed a reduction of systolic blood pressure of more than 10 mmHg, which does not comply with the established definition of orthostatic hypotension (at least 20 mm Hg below baseline).
Slovenian: Poleg tega so se vključili bolniki, pri katerih se je sistolični krvni tlak znižal za več kot 10 mmHg, kar ni skladno z uveljavljeno opredelitvijo ortostatske hipotenzije (vsaj 20 mmHg pod izhodiščno vrednostjo).
English: The CHMP was therefore requested to give its opinion on whether the marketing authorisations for ergot derivatives containing medicinal products should be maintained, varied, suspended or withdrawn in relation to the below mentioned indications:
Slovenian: Odbor CHMP so zato prosili, naj poda svoje mnenje o tem, ali je treba dovoljenja za promet z zdravili, ki vsebujejo derivate ergot-alkaloidov, ohraniti, spremeniti, začasno umakniti ali ukiniti za spodaj navedene indikacije:
English: Ergotism is a serious reaction, which leads in rare cases reported to important sequelae following amputation or colon resection for example.
Slovenian: Ergotizem je resna reakcija, ki v redkih primerih povzroči pomembne posledice, ki med drugim zahtevajo amputacijo ali resekcijo kolona.
English: From the approved indications of the dihydroergotamine containing medicinal products the ones that are in the scope of this referral procedure and are approved in at least one Member State are the following (specific wording of the indication may vary from product to product):
Slovenian: Od odobrenih indikacij za zdravila, ki vsebujejo dihidroergotamin, so indikacije, ki spadajo v sklop tega napotitvenega postopka in so odobrene v vsaj eni državi članici, naslednje (natančno besedilo za indikacijo se lahko med zdravili razlikuje):
English: However, the CHMP noted that for most of these patients an improvement or recovering had been observed after corticosteroid treatment or surgery (valve replacement), and in most cases the improvement is stated based on clinical symptoms (no scan).
Slovenian: Vendar je odbor CHMP ugotovil, da so pri večini teh bolnikov izboljšanje ali okrevanje opazili po zdravljenju s kortikosteroidi ali kirurškem posegu (zamenjavi zaklopke) in da izboljšanje pri večini bolnikov temelji na kliničnih simptomih (brez slikanja).
English: Following a national pharmacovigilance review held in 2011 new spontaneous notifications reported with some of those products identified serious cases of fibrosis and ergotism and France considered that this safety concern is not outweighed by the limited evidence of efficacy.
Slovenian: Po nacionalnem farmakovigilančnem pregledu leta 2011 so pri nekaterih od teh zdravil poročali o novih spontanih prijavah, pri katerih so ugotovili resne primere fibroze in ergotizma, zato je Francija presodila, da ta varnostna težava ne odtehta omejenih dokazov o učinkovitosti.
English: Moreover, safety data provided by some MAHs are incomplete (gap between reviewing period and marketing period of the product) and it cannot be excluded that cases reported with their products are lacking.
Slovenian: Poleg tega so varnostni podatki, ki so jih predložili nekateri imetniki dovoljenj za promet z zdravilom (presledek med obdobjem pregleda zdravila in obdobjem njegovega trženja), nepopolni, zato ni mogoče izključiti, da so primeri, poročani pri njihovih zdravilih, pomanjkljivi.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
Slovenian: • odbor je v skladu s členom 31 Direktive 2001/83/ES obravnaval napotitveni postopek za zdravila, ki vsebujejo derivate ergot-alkaloidov, pri zadevnih indikacijah;
English: Some symptoms related to ergotism may be confounded with migraine symptoms and thus not reported as an adverse drug reaction.
Slovenian: Nekateri simptomi, povezani z ergotizmom, se lahko zamenjajo s simptomi migrene, zato se niso poročali kot neželeni učinek na zdravilo.
English: In these studies, dihydroergotamine seems to have some efficacy only by injection route or at doses higher than the authorised dose.
Slovenian: Videti je, da ima dihidroergotamin v teh študijah nekaj učinkovitosti samo pri injiciranju ali odmerkih, večjih od odobrenega odmerka.
English: Overall, 8 cases of fibrotic adverse reactions from a French survey conducted in 2011 and 50 cases among the 75 cases reported by the MAHs have been considered as potentially related to dihydroergotamine including 24 with no confounding factor.
Slovenian: Na splošno se je 8 primerov fibrotičnih neželenih učinkov iz francoske raziskave, opravljene leta 2011, in 50 od 75 primerov, o katerih so poročali imetniki dovoljenj za promet z zdravilom, obravnavalo kot morebitno povezanih z dihidroergotaminom, vključno s 24 primeri brez sočasnega dejavnika.
English: • Fibrosis is also an insidious reaction that occurs after a long period of treatment and thus with often a delayed diagnosis.
Slovenian: • je fibroza zahrbtna reakcija, ki se pojavi dolgo časa po zdravljenju, diagnoza pa je zato navadno zapoznela.
English: In some published literature, they are considered as aetiology of retroperitoneal fibrosis (P. Meier et al, La fibrose rétropéritonéale, une maladie inflammatoire méconnue.
Slovenian: Nekatera objavljena literatura navaja, da so domnevni vzrok za retroperitonealno fibrozo (P. Meier in sod., La fibrose rétropéritonéale, une maladie inflammatoire méconnue.
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly
Slovenian: • simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših
English: In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the risk.
Slovenian: Za preklic začasnega umika morajo imetniki dovoljenja za promet z zdravilom ugotoviti specifično populacijo bolnikov, pri kateri so koristi zdravila večje od tveganja.
English: • Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease
Slovenian: • dodatno zdravljenje intermitentne klavdikacije pri simptomatski periferni arterijski okluzivni bolezni
English: Moreover, given the seriousness of ergotism and its consequences (sequelae, need for surgery, amputation), the young age of the patients with symptoms of ergotism and the short time to onset of the reaction, the safety profile of dihydroergotamine is highly questionable.
Slovenian: Poleg tega je zaradi resnosti ergotizma in njegovih posledic (potrebe po kirurškem posegu, amputacije), majhne starosti bolnikov s simptomi ergotizma ter hitrega pojava reakcije varnostni profil dihidroergotamina zelo vprašljiv.
English: Twelve patients suffering from peripheral venous insufficiency were treated first with intravenous dihydroergotamine followed by oral dihydroergotamine administration for one week.
Slovenian: Dvanajst bolnikov s periferno vensko insuficienco so najprej zdravili z intravenskim dihidroergotaminom, čemur je sledilo enotedensko peroralno dajanje dihidroergotamina.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations or suspension of the marketing authorisations, as applicable, taking into consideration the approved indications for each product
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom ali začasni umik dovoljenj za promet z zdravilom, kot je ustrezno, pri čemer so bile upoštevane odobrene indikacije za posamezno zdravilo
English: Moreover, the 8 new spontaneous notifications reported during the French survey conducted in 2011 show that the risk minimisation measures that are currently in place are not sufficient to prevent the risk of fibrotic reactions.
Slovenian: Poleg tega so v francoski raziskavi, opravljeni leta 2011, odkrili 8 novih, spontano poročanih primerov, kar kaže, da trenutni ukrepi za zmanjševanje tveganja niso zadostni za preprečevanje tveganja fibrotičnih reakcij.
English: Symptoms of ergotism are listed in the sections 4.8, 4.9 of all the SmPCs and ergotism is identified in section 4.4 as a consequence of a prolonged use of dihydroergotamine or high dosage.
Slovenian: Simptomi ergotizma so navedeni v poglavjih 4.8 in 4.9 vseh povzetkov glavnih značilnosti zdravila, ergotizem kot posledica dolgotrajne uporabe ali velikega odmerka dihidroergotamina pa je naveden v poglavju 4.4.
English: Based on the clinical experience the group considered that dihydroergotamine has only been used rarely for the treatment of orthostatic hypotension with no clear benefit to the patients.
Slovenian: Na podlagi kliničnih izkušenj je skupina menila, da se je dihidroergotamin le redko uporabljal za zdravljenje ortostatske hipotenzije, pri čemer ni bilo jasnih koristi za bolnike.
English: The literature data indicate a possible efficacy of oral dihydroergotamine in migraine prophylaxis, but definite scientific proof remains weak.
Slovenian: Podatki iz literature kažejo na morebitno učinkovitost peroralnega dihidroergotamina pri preprečevanju migrene, vendar so potrjeni znanstveni dokazi šibki.
English: The patients disease is not well defined, nor the efficacy endpoints.
Slovenian: Bolezen bolnikov in opazovani dogodki za učinkovitost niso dobro opredeljeni.
English: The CHMP considered the MAHs' proposals for risk minimisation measures.
Slovenian: Odbor CHMP je obravnaval predloge imetnikov dovoljenj za promet z zdravilom glede ukrepov za zmanjšanje tveganja.
English: The MAHs also submitted their own overviews and critical summaries of all spontaneous reports of fibrotic reactions (cardiac with or without pulmonary arterial hypertension, pulmonary, pleural, peritoneal, retroperitoneal, etc) and ergotism with their ergot derivatives-containing medicinal products.
Slovenian: Imetniki dovoljenj za promet z zdravilom so prav tako predložili svoje preglede in kritične povzetke vseh spontanih poročil o fibrotičnih reakcijah (srčnih s pljučno arterijsko hipertenzijo ali brez nje, pljučnih, plevralnih, peritonealnih, retroperitonealnih ipd.) in ergotizmu pri svojih zdravilih, ki vsebujejo derivate ergot-alkaloidov.
English: Some of them were conducted with the intravenous administration which is not in the scope of this referral procedure for dihydroergotamine.
Slovenian: Nekatere od njih so izvedli z injiciranjem, ki ne spada v sklop tega napotitvenega postopka za dihidroergotamin.