natgillin/translations-raw huggingface dataset:
Moreover the severity of such adverse effects, their possible fatal outcome and the raised risk for patient to develop a fibrotic disorder with long term use according to the authorised indications should be underlined.
Poleg tega je treba izpostaviti resnost teh neželenih učinkov, njihov morebitni smrtni izid in povečano tveganje za razvoj fibrotične motnje pri dolgotrajni uporabi, skladni z odobrenimi indikacijami.
Under-reporting can also be suspected because the substance has been on the market for a long time and because fibrosis is already mentioned as an undesirable effect in the product information.
Prav tako obstaja sum na preredko poročanje, saj je učinkovina v prometu že dolgo časa in je fibroza že omenjena kot neželeni učinek v informacijah o zdravilu.
Of these, 18 concerned placebocontrolled trials, 2 concerned actively-controlled trials and 7 concerned open label studies.
Od teh se jih je 18 nanašalo na s placebom nadzorovana preskušanja, 2 na z zdravilno učinkovino nadzorovani preskušanji, 7 pa na odprte študije.
Although some of the proposed measures could help identify patients with pre-existing fibrosis, relevant concomitant medication and increased risk, the Committee pointed out that they are insufficient to avoid that some patients develop fibrosis and ergotism during treatment.
Čeprav lahko nekateri od predlaganih ukrepov pomagajo odkriti bolnike z obstoječo fibrozo, zadevna sočasna zdravila in povečano tveganje, je Odbor izpostavil, da to ni zadostno za preprečevanje razvoja fibroze in ergotizma med zdravljenjem pri nekaterih bolnikih.
Dihydroergocristine is a partial agonist of α-adrenoreceptors that decreases the activity of sympathetic centres and is responsible for a peripheral adrenolytic effect with an increased venous wall tone.
Dihidroergokristin je delni agonist alfa-adrenoreceptorjev, ki zmanjša dejavnost simpatičnih centrov in je odgovoren za periferni adrenolitični učinek s povečanim tonusom venskih sten.
From the approved indications of the dihydroergocristine 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):
Od odobrenih indikacij za zdravila, ki vsebujejo dihidroergokristin, 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):
While it is agreed that the medical terminology used nowdays and in the past differs and that the data needs to be assessed bearing this aspect in mind, the clinical symptom of dementia is a result of various pathophysiological processes which makes pooling and comparison of the data difficult, especially when the individual studies used slightly different inclusion criteria.
Medtem ko je jasno, da se današnja medicinska terminologija razlikuje od tiste v preteklosti in da je treba to upoštevati pri ocenjevanju podatkov, je klinični simptom demence rezultat različnih patofizioloških procesov, zaradi česar je združevanje in primerjanje podatkov oteženo, predvsem ker so posamezne študije uporabljale rahlo različna merila za vključevanje preskušancev.
In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the product outweigh the identified risk.
Za preklic začasnega umika morajo imetniki dovoljenja za promet z zdravilom ugotoviti specifično populacijo bolnikov, pri kateri so koristi zdravila večje od ugotovljenega tveganja.
The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation.
Imetniki dovoljenj za promet z zdravilom so predložili vse razpoložljive podatke o učinkovitosti iz kliničnih preskušanj in opazovalnih študij, vključno s podatki, ki so se pridobili po odobritvi prvotnega dovoljenja za promet z zdravilom.
Among these 3 studies, the publications by Lazzaroni et al and Aranda et al indicated superiority over placebo, while the study by Vellas et al demonstrated similar efficacy to placebo.
Pri teh 3 študijah sta objavi Lazzaronija in sodelavcev ter Arande in sodelavcev pokazali superiornost v primerjavi s placebom, študija Vellasa in sodelavcev pa je pokazala učinkovitost, podobno placebu.
However, in this study with adequate methodological quality standard, non-significant difference between dihydroergocristine + raubasine and placebo groups was observed.
Vendar v tej študiji z zadostnim standardom metodološke kakovosti niso opazili pomembne razlike med skupinami s kombinacijo dihidroergokristina ter ravbazina in placebom.
• The Committee considered that a potential causal association between fibrotic reactions or ergotism and dihydroergocristine cannot be excluded.
• odbor je menil, da morebitne vzročne povezave med fibrotičnimi reakcijami ali ergotizmom in dihidroergokristinom ni mogoče izključiti.
In addition, on the basis of the reported cases, vasoconstriction induced by dihydroergocristine cannot be excluded.
Poleg tega na podlagi poročanih primerov ni mogoče izključiti vazokonstrikcije, ki jo povzroča dihidroergokristin.
This is indicative of a causal relationship between fibrosis and dihydroergocristine.
To kaže na vzročno povezavo med fibrozo in dihidroergokristinom.
All the data submitted were reviewed and considered, and though it can be interpreted as suggestive of mild efficacy of dihydroergocristine in the”treatment of chronic cognitive impairment in the elderly”, efficacy cannot be considered as sufficiently demonstrated namely due to the inconsistency of the data generated in the larger trials.
Pregledali in upoštevali so se vsi predloženi podatki in čeprav kažejo na blago učinkovitost dihidroergokristina pri „zdravljenju kronične kognitivne okvare pri starejših“, učinkovitosti ni mogoče obravnavati kot zadostno dokazane zaradi nedoslednosti podatkov, pridobljenih v večjih preskušanjih.
The data from the reported cases of fibrosis (n=12) are indicative of the capacity of dihydroergocristine to induce fibrotic reactions, mostly localised in the pulmonary area considering also the improvement of some patients following discontinuation of the product.
Podatki o poročanih primerih fibroze (n = 12) kažejo na zmožnost dihidroergokristina za povzročanje fibrotičnih reakcij, predvsem lokaliziranih v pljučnem območju, kar se je pokazalo tudi z izboljšanjem pri nekaterih bolnikih po prekinitvi uporabe zdravila.
The CHMP also noted the position of one of the MAHs that due to the limitations of the data available, the ocular indicaton cannot be upheld.
Odbor CHMP je prav tako upošteval mnenje enega od imetnikov dovoljenj za promet z zdravilom, da zaradi omejitev razpoložljivih podatkov očesne indikacije ni mogoče ohraniti.
Moreover, it was pointed out that topical instillations of dihydroergocristine are out of the scope of this procedure.
Poleg tega je izpostavil, da je topično vkapavanje dihidroergokristina zunaj sklopa tega postopka.
It is available in combination with raubasine that is an adrenolytic and sympatholytic agent with an inhibitory effect on sympathetic centres.
Na voljo je v kombinaciji z ravbazinom, adrenolitično in simpatikolitično učinkovino z zaviralnim učinkom na simpatične centre.
It should also be underlined that reports of reduction of the extension of the fibrotic plaque a long time after dihydroergocristine withdrawal, improvements after dihydroergocristine discontinuation and positive rechallenge (symptoms re-occurring on readministration) have been reported.
Prav tako je treba izpostaviti, da so poročali o zmanjšanju obsežnosti fibrotičnega plaka dolgo po prekinitvi uporabe dihidroergokristina, izboljšanju po prekinitvi dihidroergokristina in pozitivni provokaciji (ponovnem pojavu simptomov po ponovni uporabi).
Based on these data and based on the pharmacological plausibility, dihydroergocristine is considered to be associated with fibrotic reactions.
Na podlagi teh podatkov in farmakološke verjetnosti menijo, da je dihidroergokristin povezan s fibrotičnimi reakcijami.
These included limiting treatment duration in certain conditions, contraindicating the product in patients with pre-existing fibrosis or in association with other drugs, the issuing of a DHPC highlighting the risk, a checklist for prescribers, and a pharmacological in vitro study for 5-HT subclass receptors affinity to the product.
Ti so vključevali omejitev trajanja zdravljenja pri nekaterih pogojih, kontraindikacijo zdravila pri bolnikih z obstoječo fibrozo ali kontraindikacijo za kombinacije z drugimi zdravili, izdajo neposrednega obvestila zdravstvenim delavcem, ki izpostavlja tveganje, kontrolni seznam za predpisovalce ter izvedbo farmakološke študije in vitro za afiniteto podrazreda receptorjev 5-HT za zdravilo.
In addition it has a pharmacological action on the serotoninergic and dopaminergic receptors leading to interesting effects on cerebral metabolism.
Poleg tega ima farmakološki učinek na serotoninergične in dopaminergične receptorje, kar povzroča zanimive učinke na presnovo v možganih.
• The Committee considered that the benefit-risk balance of dihydroergocristine containing products:
• odbor je menil, da razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo dihidroergokristin:
• The suspension of the marketing authorisation for dihydroergocristine containing medicinal products referred to in Annex I in the event that no other indications are approved as part of their marketing authorisation.
• začasni umik dovoljenja za promet z zdravili iz Priloge I, ki vsebujejo dihidroergokristin, če se kot del njihovega dovoljenja za promet z zdravilom ne odobrijo nobene druge indikacije.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
• odbor je v skladu s členom 31 Direktive 2001/83/ES obravnaval napotitveni postopek za zdravila, ki vsebujejo dihidroergokristin, pri zadevnih indikacijah;
A scientific advisory group (SAG) was convened in December 2012 at the request of the CHMP during which the experts discussed, based on their clinical experience, whether this substance plays a role in the symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Znanstveno svetovalna skupina je na pobudo odbora CHMP decembra 2012 sklicala sestanek, na katerem so strokovnjaki na podlagi svojih kliničnih izkušenj razpravljali o tem, ali ima ta učinkovina vlogo pri simptomatskem zdravljenju kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence).
− Is not favourable for acute retinopathies of vascular origin.
− ni ugodno za akutno retinopatijo žilnega izvora;
• Symptomatic treatment of veno-lymphatic insufficiency
• simptomatsko zdravljenje veno-limfatične insuficience.
The Committee concluded that the benefit-risk balance of dihydroergocristine containing products is not favourable pursuant to Article 116 of Directive 2001/83/EC for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia), for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin and for acute retinopathies of vascular origin.
Odbor je zaključil, da skladno s členom 116 Direktive 2001/83/ES razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo dihidroergokristin, ni ugodno za simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence), dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora, ter akutno retinopatijo žilnega izvora.
Even if in some cases, confounding treatment (known to induce fibrotic reaction) have been coadministrated, the relationship between fibrotic reactions observed and treatment with dihydroergocristine cannot be excluded.
Čeprav se je v nekaterih primerih sočasno uporabila dodatna oblika zdravljenja (za katero je znano, da povzroča fibrotično reakcijo), povezave med opaženimi fibrotičnimi reakcijami in zdravljenjem z dihidroergokristinom ni mogoče izključiti.
Overall, the varying affinity for serotoninergic receptors with the different ergot derivatives and the therapeutic doses used may explain the differences observed for notification rates for the fibrotic reactions.
Na splošno lahko spreminjajoča afiniteta za serotoninergične receptorje pri različnih derivatih ergotalkaloidov in terapevtskih odmerkih pojasni razlike, opažene pri poročanih deležih fibrotičnih reakcij.
The relationship between fibrosis and serotininergic receptor activation, particularly 5-HT2B receptors by ergot derivatives is extensively described in the literature.
Povezava med fibrozo in aktivacijo serotoninergičnih receptorjev, predvsem receptorjev 5-HT2B, ki jo povzročajo derivati ergot-alkaloidov, je obširno opisana v literaturi.
• The variation to the terms of the marketing authorisation for dihydroergocristine containing medicinal products referred to in Annex I, to delete the below indications from the Product Information (specific wording of the indication may vary from product to product and from country to country) as well as any relevant reference to these indications in the Product Information, when there are other therapeutic indications approved as part of their marketing authorisation:
• spremembo pogojev dovoljenja za promet z zdravili iz Priloge I, ki vsebujejo dihidroergokristin, tako da se iz informacij o zdravilu izbrišejo spodaj navedene indikacije (natančno besedilo za indikacijo se lahko med zdravili in državami razlikuje) ter druge zadevne reference na te indikacije, kadar so kot del dovoljenja za promet z zdravilom odobrene druge terapevtske indikacije:
For the indications “ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin” and “acute retinopathies of vascular origin”, the few preclinical findings submitted reporting the effects of topical doses of dihydroergocristine were considered by the CHMP insufficient to support the use of dihydroergocristine as intraocular pressure (IOP) lowering agent in human or for other ocular conditions presumably of vascular origin.
Pri indikacijah „dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora“ in „akutna retinopatija žilnega izvora“ je odbor CHMP glede na nekaj predloženih predkliničnih ugotovitev, ki poročajo o učinkih topičnih odmerkov dihidroergokristina, menil, da so te nezadostne, da bi podprle uporabo dihidroergokristina kot učinkovine za zniževanje očesnega tlaka pri ljudeh ali druga očesna stanja, za katere se domneva, da so žilnega izvora.
The MAHs submitted 27 literature references to support the efficacy of dihydroergocristine on the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”.
Imetniki dovoljenj za promet z zdravilom so predložili 27 referenc iz literature za podporo učinkovitosti dihidroergokristina pri indikaciji „simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)“.
There are 2 further studies by Hugonot et al with population of 114-127 patients, both showing superiority over placebo.
Hugonot in sodelavci so opravili 2 študiji s populacijo od 114 do 127 bolnikov.
Grounds for the variation/suspension to the terms of the marketing authorisations
Razlogi za spremembo pogojev dovoljenj za promet z zdravilom ali njihov začasni umik
The most recent study (Vellas 1998 - Not published) that became available after the granting of the initial marketing autohrisation, uses a standardised definition of diagnosis (patients had to present a moderate memory deficit, with a Mini-Mental Sate Examination MMSE > 25 and a score total > 38 and < 70 on the Mac Nair and Kahn auto-questionnaire assessing the difficulties in daily activities) and defines the primary efficacy criterion a priori (the Mac Nair and Kahn auto-questionnaire and the Gröber and Buschke test).
MMSE) > 25 ter skupnim rezultatom > 38 in < 70 pri samostojnem vprašalniku Mac Nair in Kahn, ki ocenjuje težave pri vsakdanjih dejavnostih) in a priori opredeljuje primarno merilo za učinkovitost (samostojni vprašalnik Mac Nair in Kahn ter Gröber-Buschkejev test).
− Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
− simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence),
Its effect results mainly from its α1-blocking properties.
Njegovi učinki so večinoma posledica značilnosti zaviranja alfa-adrenergičnih receptorjev 1.
Additionally one case of retroperitoneal fibrosis was reported in the literature (concerning fibrotic plaque), and a scan performed one year after the discontinuation of dihydroergocristine revealed a marked reduction of the fibrotic plaque which was considered by the CHMP in favour of a causal relationship between the retroperitoneal fibrosis observed and dihydroergocristine.
Slikanje, opravljeno eno leto po prekinitvi dihidroergokristina, je pokazalo znatno zmanjšanje fibrotičnega plaka, kar je odbor CHMP obravnaval kot vzročno povezavo med opaženo retroperitonealno fibrozo in dihidroergokristinom.
It is available as capsules (50 and 100 mg) and tablets (100 and 400 mg).
Na voljo je v obliki kapsul (50 in 100 mg) in tablet (100 in 400 mg).
It has also been examined in a fourth main study involving 160 children and young people aged 1 to 22 years.
Proučevali so ga tudi v četrti glavni študiji, v katero je bilo vključenih 160 otrok in mladih, starih od 1 do 22 let.
The European Commission granted a marketing authorisation valid throughout the European Union for Glivec on 7 November 2001.
Evropska komisija je dovoljenje za promet z zdravilom Glivec, veljavno po vsej Evropski uniji, odobrila dne 7. novembra 2001.
The full EPAR for Glivec can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Glivec je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
These studies examined whether blood cell counts returned to normal levels, or whether the number of cancerous blood cells or the size of tumours fell.
S temi študijami so proučevali ali se je število krvnih celic vrnilo na normalno raven oziroma ali sta se število rakavih krvnih celic ali velikost tumorjev zmanjšala.
This is a summary of the European public assessment report (EPAR) for Glivec.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Glivec.
Due to their rarity, limited data were available for the other diseases, but around two thirds of the patients showed at least a partial response to Glivec.
Zaradi redkosti so bili za te bolezni na voljo le omejeni podatki, vendar pa je približno dve tretjini bolnikov izkazalo vsaj delen odziv na zdravilo Glivec.
The most common side effects with Glivec (seen in more than 1 in 10 patients) are weight increase, neutropenia (low levels of the white blood cells that fight infection), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), abdominal (tummy) pain, periorbital oedema (swelling around the eyes), rash, muscle spasm and cramps, muscle, bone and joint pain, fluid retention and fatigue (tiredness).
Najpogostejši neželeni učinki zdravila Glivec (opaženi pri več kot 1 bolniku od 10), so zvišanje telesne mase, nevtropenija (nizko število belih krvnih celic, ki se borijo proti okužbi), trombocitopenija (nizko število trombocitov), anemija (nizko število rdečih krvnih celic), glavobol, navzeja (slabost), bruhanje, driska, dispepsija (slaba prebava), bolečine v trebuhu, periorbitalni edemi (otekanje okrog oči), izpuščaji, mišični spazem in krči, bolečine v mišicah, kosteh in sklepih, zastajanje tekočine in utrujenost.
For more information about treatment with Glivec, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Glivec preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Glivec
Druge informacije o zdravilu Glivec
By blocking these receptors, Glivec helps to control cell division.
Z zaviranjem teh receptorjev zdravilo Glivec pomaga pri nadzoru nad delitvijo celic.
It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another anticancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Uporablja se tudi pri odraslih in otrocih v kronični fazi bolezni, če se ta ne odziva na zdravljenje z interferonom alfa (drugim zdravilom proti raku) ter v napredovalih fazah bolezni („pospešeni fazi“ in „blastni krizi“).
The CHMP decided that Glivec's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Glivec večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Glivec shown during the studies?
Kakšne koristi je zdravilo Glivec izkazalo med študijami?
For GIST, Glivec has been examined in two main studies.
Pri GIST je bilo zdravilo Glivec raziskano v dveh glavnih študijah.
The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Odmerjanje je odvisno od zdravljene bolezni, starosti in stanja bolnika ter odziva na zdravljenje, vendar pa ne sme preseči 800 mg na dan. Za več informacij glejte navodilo za uporabo.
For CML, Glivec has been examined in four main studies involving 2,133 adults and one study of 54 children.
Za KML so zdravilo Glivec proučevali v štirih glavnih študijah, v katere je bilo vključenih 2 133 odraslih, in eni študiji s 54 otroki.
Glivec was more effective than the comparator medicines.
Zdravilo Glivec je bilo učinkovitejše od primerjalnih zdravil.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Glivec.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Glivec, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Glivec is an anticancer medicine.
Glivec je zdravilo proti raku.
What is the risk associated with Glivec?
Kakšna tveganja so povezana z zdravilom Glivec?
This study did not compare Glivec with any other medicines.
V tej študiji zdravila Glivec niso primerjali z drugimi zdravili.
Glivec must not be used in people who are hypersensitive (allergic) to imatinib or any of the other ingredients.
Zdravila Glivec ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) imatinib ali katero koli drugo sestavino zdravila.
For MD/MPD (31 patients), HES and CEL (176 patients), and DFSP (18 patients), Glivec was not compared with any other medicines.
Pri MD/MPD (31 bolnikov), HES in KEL (176 bolnikov) in DFSP (18 bolnikov) zdravila Glivec niso primerjali z nobenim drugim zdravilom.
Glivec is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Zdravilo Glivec se zaužije peroralno z obrokom hrane in velikim kozarcem vode, da bi tako zmanjšali tveganje za draženje želodca in črevesja.