FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the MAH agreed to perform a mechanistic study to provide further insight into the effects on platelet aggregation of cilostazol with aspirin or clopidogrel and their consequences on bleeding time.
Slovenian: Poleg tega se je imetnik dovoljenja za promet z zdravilom strinjal, da bo izvedel študijo mehanizma delovanja za razjasnitev vpliva cilostazola v kombinaciji z aspirinom ali klopidogrelom na agregacijo trombocitov in posledično na čas krvavitev.
English: The CHMP was therefore of the opinion that cilostazol has a statistically significant, albeit modest effect on walking distances in patients with IC and that some patients may benefit to a clinically relevant degree.
Slovenian: Zato je CHMP menil, da ima cilostazol majhen, vendar statistično pomemben učinek na podaljšanje prehojene razdalje pri bolnikih z IK in da ima lahko pri nekaterih bolnikih klinično pomembne koristi.
English: Pooled meta-analyses of patient reported outcomes from the short-form health survey (SF-36) and the Walking Impairment Questionnaire (WIQ) demonstrated significant effects of cilostazol over placebo on physical functioning and the physical component score of the SF-36, as well as significant improvements in WIQ speed and distance scores.
Slovenian: Metaanalize združenih izidov, ki so jih bolniki navedli v vprašalniku o kakovosti življenja (SF-36) in vprašalniku o težavah pri hoji (Walking Impairment Questionnaire - WIQ), so pokazale pomembne klinične učinke cilostazola v primerjavi s placebom na telesno zmogljivost in izboljšanje rezultatov telesne komponente vprašalnika SF-36 ter tudi pomembno izboljšanje rezultatov na WIQ, povezanih s hitrostjo in razdaljo.
English: The increase in walking distance over baseline walking distance with cilostazol treatment was 35% higher than with placebo.
Slovenian: Stopnja izboljšanja prehojene razdalje v primerjavi z izhodiščno je bila pri zdravljenju s cilostazolom za 35 % višja kot pri placebu.
English: Given the increase in exposure to cilostazol resulting from concomitant use of CYP3A4 and CYP2C19 inhibitors (such as erythromycin, ketoconazole and omeprazole), the CHMP considered that there is a high potential for interactions with other medicinal products that could increase the risks associated with cilostazol and therefore considered that the SmPC wording in section 4.5 should be strengthened.
Slovenian: Zaradi dejstva, da se pri sočasni uporabi zaviralcev CYP3A4 in CYP2C19 (na primer eritromicina, ketokonazola in omeprazola) poveča izpostavljenost cilostazolu, je CHMP menil, da obstaja velika verjetnost za medsebojno delovanje z drugimi zdravili, kar bi lahko povečalo tveganja, povezana s cilostazolom, zato je zaključil, da bi bilo treba okrepiti opozorila v poglavju 4.5 v povzetku glavnih značilnosti zdravila.
English: In terms of safety, clinical trial data showed that the most commonly-reported adverse events are headaches, diarrhoea, dizziness, palpitations, peripheral oedema and tachycardia, and these adverse events were listed in the product information.
Slovenian: Glede varnosti zdravila so podatki iz kliničnih preskušanj pokazali, da so bili neželeni dogodki, o katerih so največkrat poročali, glavobol, driska, omotica, palpitacije, periferni edem in tahikardija, in da so ti neželeni dogodki že vključeni v informacije o zdravilu.
English: Also, cilostazol should only be initiated by physicians experienced in the management of intermittent claudication after suitability of treatment with cilostazol has been carefully considered, alongside other treatment options such a revascularisation.
Slovenian: Poleg tega lahko cilostazol predpišejo samo zdravniki, ki imajo izkušnje z zdravljenjem bolnikov z intermitentno klavdikacijo, potem ko skrbno preučijo ustreznost zdravljenja s cilostazolom in druge možnosti zdravljenja, kot je na primer revaskularizacija.
English: The experts considered that the included patients were a reasonable representation of real-life and it was hard to argue that the study was not reassuring and agreed that cilostazol has shown a consistent trend for being as safe as placebo across the major cardiovascular endpoints.
Slovenian: Strokovnjaki so menili, da so bolniki, ki so bili vključeni v študijo, dobro odražali populacijo v resničnem življenju, zato so jih rezultati študije povsem pomirili, strinjali pa so se tudi, da je cilostazol izkazal stabilen trend varnosti, ki je bila primerljiva s placebom pri vseh pomembnejših kardiovaskularnih opazovanih dogodkih.
English: Cilostazol is a dihydro-quinolinone derivative that belongs to the pharmacotherapeutic group antithrombotic agents, platelet aggregation inhibitor excluding heparin.
Slovenian: Cilostazol je derivat dihidrokinolinona, ki spada v farmakoterapevtsko skupino, imenovano antitrombotiki, zaviralci agregacije trombocitov brez heparina.
English: The pharmacovigilance measures should be increased by submitting 6-monthly PSURs including safety reports focused on cardiovascular adverse events, haemorrhagic adverse events and off-label use.
Slovenian: Okrepiti je treba farmakovigilančne dejavnosti, v okviru katerih je treba vsakih šest mesecev predložiti posodobljeno poročilo o varnosti zdravila (PSUR) s poudarkom na kardiovaskularnih neželenih dogodkih in krvavitvah ter uporabi, ki ni skladna z odobrenimi indikacijami.
English: No major safety concerns were identified from the clinical trials.
Slovenian: Podatki iz kliničnih preskušanj niso povzročili nobenih večjih zadržkov glede varnosti.
English: No signal for increased mortality was observed in clinical trials, including the CASTLE study.
Slovenian: V kliničnih preskušanjih, vključno s študijo CASTLE, niso opazili znakov, ki bi kazali na povečano smrtnost.
English: In view of this, the CHMP considered that cilostazol should be contraindicated in patients with a history of severe tachyarrhythmia and that additional warnings should be introduced in the PI.
Slovenian: Zato je CHMP menil, da bi morala biti uporaba cilostazola kontraindicirana pri bolnikih, ki imajo v anamnezi hudo tahiaritmijo, in da bi morali v informacije o zdravilu vključiti dodatna opozorila.
English: The Spanish authority's main concerns centred on reports received of cardiovascular reactions (including fatal cases of MI, angina pectoris and arrhythmias) and haemorrhagic reactions as well as drug interactions.
Slovenian: Španski pristojni organi so bili zaskrbljeni zlasti zaradi poročil o kardiovaskularnih neželenih učinkih (vključno s primeri srčnega infarkta s smrtnim izidom, angino pektoris in aritmijami) in hemoragičnih neželenih učinkih ter tudi medsebojnem delovanju z drugimi zdravili.
English: Point estimates in all nine trials favoured cilostazol 100mg bid over placebo and the analysis demonstrated statistical superiority of cilostazol over placebo in six of the nine trials.
Slovenian: Ocenjene vrednosti v vseh devetih preskušanjih so bile v korist cilostazola v odmerku 100 mg dvakrat na dan, analiza pa je pokazala, da je bil cilostazol od placeba statistično boljši v šestih od devetih preskušanj.
English: • The Committee considers that the benefit of cilostazol is modest but that a statistically significant increase in walking distance compared with placebo has been shown in patients with intermittent claudication;
Slovenian: • Odbor meni, da so koristi cilostazola majhne, vendar pa so pri bolnikih z intermitentno klavdikacijo opazili statistično pomembno izboljšanje prehojene razdalje v primerjavi s placebom;
English: The concerns relating to interactions with other medications (in particular CYP3A4 and CYP2C19 inhibitors) and the possibility of an increased risk for adverse effects have been addressed by the recommendation of a dose reduction to 50mg bid in patients taking concomitant medicines that inhibit these enzymes.
Slovenian: Zaradi skrbi glede medsebojnega delovanja z drugimi zdravili (zlasti z zaviralci CYP3A4 in CYP2C19) in možnosti povečanega tveganja za neželene učinke je Odbor pri bolnikih, ki uporabljajo zdravila, ki zavirajo omenjena encima, predlagal zmanjšanje odmerka na 50 mg dvakrat na dan.
English: The first DUS' will obtain baseline data with the objective to describe the characteristics of new users of cilostazol and the duration of the use of cilostazol and discontinuation patterns.
Slovenian: V prvi študiji bodo pridobili osnovne podatke za opredelitev značilnosti novih uporabnikov cilostazola in trajanja uporabe ter vzorcev prekinitve zdravljenja.
English: Cilostazol is associated with a modest but statistically significant increase in walking distance compared with placebo in patients with IC, and this has also been demonstrated using quality of life measurements.
Slovenian: Cilostazol je zmerno, vendar statistično pomembno podaljšal prehojeno razdaljo v primerjavi s placebom pri bolnikih z IK, kar so potrdile tudi ocene kakovosti življenja.
English: In addition, considering its anti-platelet activity, cilostazol is expected to increase the risk of bleeding.
Slovenian: Poleg tega je mogoče pričakovati, da bi cilostazol s svojim antiagregacijskim delovanjem povečal tveganje za krvavitve.
English: Other adverse events of interest such as myocardial ischemia (myocardial infarction, angina pectoris, coronary artery disease), congestive heart failure and hypotension, were also identified during the mid-term efficacy clinical trials, with a higher incidence in the cilostazol group compared to placebo.
Slovenian: Med srednjeročnimi kliničnimi preskušanji učinkovitosti so se pojavili tudi drugi pomembni neželeni učinki, na primer ishemična bolezen srca (srčni infarkt, angina pektoris, koronarna arterijska bolezen), kongestivno srčno popuščanje in hipotenzija, pri čemer je bila njihova pogostnost večja v skupini s cilostazolom kot v skupini s placebom.
English: • The Committee is of the opinion that some patients may benefit from cilostazol treatment to a clinically relevant degree; however, in view of the existing safety concerns, the Committee considered it appropriate to restrict use to those who have not responded to lifestyle treatment and to recommend that treatment is only continued in those who have shown a meaningful response within the first 3 months;
Slovenian: • Odbor meni, da bi cilostazol pri nekaterih bolnikih lahko izkazal klinično pomembne koristi; vendar pa je zaradi obstoječih zadržkov glede varnosti Odbor presodil, da je treba uporabo omejiti na tiste bolnike, ki se ne odzovejo na zdravljenje s spremembami življenjskega sloga,
English: Cilostazol's effect on absolute walking distances on the treadmill, expressed as an absolute increase over baseline walking distance ranged from +23m to +109m, compared with -2m to +65m for placebo.
Slovenian: Učinek cilostazola na absolutno prehojeno razdaljo na tekočem traku, izražen kot absolutno podaljšanje prehojene razdalje glede na izhodišče, je znašal od +23 m do +109 m, učinek placeba pa od -2 m do +65 m. Metaanaliza tehtane srednje razlike (weighted mean difference - WMD) iz devetih preskušanj je prav tako pokazala dosledno učinkovitost cilostazola.
English: The second DUS will have the objective to evaluate the effectiveness of the proposed SmPC changes, educational initiatives and other implemented risk minimisation measures in terms of the mitigation of off-label use and adherence of prescribers to the SmPC, in comparison with baseline data.
Slovenian: Cilj druge študije bo na podlagi primerjave z osnovnimi podatki oceniti, ali so predlagane spremembe povzetka glavnih značilnosti zdravila, izobraževalne pobude in drugi sprejeti ukrepi za zmanjšanje tveganja učinkoviti v smislu zmanjšanja uporabe, ki ni skladna z odobrenimi indikacijami, in upoštevanja povzetka glavnih značilnosti pri predpisovanju zdravila.
English: In order to minimise the risk of drug metabolism interaction, warnings have been introduced in the SmPC and it is now recommended to reduce the dose to 50mg bid in patients taking medicines that inhibit CYP3A4 or 2C19.
Slovenian: Za zmanjšanje tveganja za vpliv drugih zdravil na presnovo cilostazola so bila v povzetek glavnih značilnosti zdravila vključena dodatna opozorila, poleg tega pa je sedaj pri bolnikih, ki jemljejo zaviralce CYP3A4 ali 2C19, priporočeno zmanjšanje odmerka na 50 mg dvakrat na dan.
English: This reduced dose has been shown to be clinically effective in clinical trials in patients using CYP3A4 or CYP2C19 inhibitors.
Slovenian: Poleg tega je CHMP priporočil, naj se pri sočasni uporabi z omenjenimi zdravili odmerek cilostazola zmanjša na 50 mg dvakrat na dan. Klinično učinkovitost tega odmerka so potrdili v kliničnih študijah pri bolnikih, ki so uporabljali zaviralce CYP3A4 ali CYP2C19.
English: The Committee concluded that the benefit-risk balance of cilostazol products for the improvement of the maximal walking distance and maximal pain-free walking distances in patients with intermittent claudication (IC), who do not have rest pain and who do not have evidence of peripheral tissue necrosis (peripheral arterial disease Fontaine stage II) remains positive under normal conditions of use, subject to restrictions, warning, changes to the product information and risk minimisation measures agreed.
Slovenian: Odbor je zaključil, da razmerje med tveganji in koristmi za zdravila, ki vsebujejo cilostazol in se uporabljajo za izboljšanje najdaljše prehojene razdalje in najdaljše razdalje, prehojene brez bolečin, pri bolnikih z intermitentno klavdikacijo (IK), ki nimajo bolečin med mirovanjem in ne kažejo znakov odmiranja perifernih tkiv (periferne arterijske bolezni (PAB) v II.
English: The vasodilatory effects of cilostazol may also be mediated through an increase in cAMP.
Slovenian: Zaradi zvišanja ravni cAMP ima lahko cilostazol tudi vazodilatacijske učinke.
English: Overall, the group was of the view that for a small group of patients with low risk of cardiovascular co-morbidities, limiting intermittent claudication who cannot manage initial exercise rehabilitation, or who are unsuitable for revascularisation, this drug may have a role.
Slovenian: Skupina je podprla predlog imetnikov dovoljenj za promet z zdravili, naj se pri nekaterih podskupinah bolnikov priporoči zmanjšanje odmerka na 50 mg dvakrat na dan. Na splošno je skupina menila, da bi zdravilo lahko imelo koristi pri majhni skupini bolnikov z nizkim tveganjem za sočasne kardiovaskularne bolezni ali intermitentno klavdikacijo, ki jim preprečuje, da bi začeli telesno dejavnost, in pri bolnikih, ki niso primerni za revaskularizacijo.
English: The anti-platelet activity of cilostazol also raised a concern for haemorrhagic events.
Slovenian: Zaradi antiagregacijskega delovanja cilostazola so se pojavile tudi skrbi zaradi morebitnih krvavitev.
English: 5 x 1 bottle (unit pack)
Slovenian: 5 x 1 steklenica (posamično pakiranje)
English: EU Number
Slovenian: Številka eu
English: Packaging Content
Slovenian: Ovojnina Vsebina
English: The study will therefore be repeated, with the final results expected to be ready by the end of June 2013.
Slovenian: Študija bo zato ponovljena, končni rezultati pa se pričakujejo konec junija 2013.
English: In all three media, both products released more than 85% or close to 85% of the drug substance within 15 minutes and more than 95% in 20 minutes.
Slovenian: V vseh treh sredstvih je zdravilo sprostilo več kot 85 % ali skoraj 85 % zdravilne učinkovine v 15 minutah ter več kot 95 % v 20 minutah.
English: Overall summary of the scientific evaluation of Cilazapril Teva and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Cilazapril Teva in povezanih imen (glejte Prilogo I)
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Cilazapril Teva and associated names.
Slovenian: • Odbor je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravilo Cilazapril Teva in povezana imena.
English: The report covers the period 1st January 2009 to 31st December 2011 and identified two case reports, both of which were medically confirmed reports describing non-serious adverse reactions.
Slovenian: V poročilu, ki zajema obdobje od 1. januarja 2009 do 31. decembra 2011, sta bili obravnavani dve zdravstveno potrjeni poročili o primeru, v katerih so opisani neresni neželeni učinki.
English: Cilazapril Teva is available as 0.5 mg, 1 mg and 2.5 mg and 5 mg tablets.
Slovenian: Zdravilo Cilazapril Teva je na voljo v obliki 0,5-, 1-, 2,5- in 5-miligramskih tablet.
English: Cilazapril Teva contains cilazapril, a pyridazine angiotensin-converting enzyme inhibitor (ACE inhibitor) used for the treatment of hypertension and congestive heart failure.
Slovenian: Zdravilo Cilazapril Teva vsebuje cilazapril, piridazinski zaviralec angiotenzin-konvertaze (zaviralec ACE), ki se uporablja za zdravljenje hipertenzije in kongestivnega srčnega popuščanja.
English: Finally the MAH noted that the periodic safety update report (PSUR) no. 383/01/12, dated February 13th 2012, reported no increased number of safety concerns with cilazapril.
Slovenian: Na koncu je imetnik dovoljenja za promet z zdravilom omenil, da v rednem posodobljenem poročilu o varnosti zdravila (PSUR) št. 383/01/12 z dne 13. februarja 2012 ni navedbe o povečanem številu varnostnih težav s cilazaprilom.
English: Only minor deficiencies were identified, which were not considered to influence the outcome of the clinical bioequivalence (e.g. exact EDTA matrix not specified, validated batch size not given, no influence of haemolytic or lipidaemic plasma shown, matrix effect in 4 different plasma batches shown).
Slovenian: Ugotovili so samo majhne razlike, za katere so menili, da ne bodo vplivale na izid klinične biološke enakovrednosti (npr. natančen matriks EDTA ni opredeljen, velikost validirane serije ni navedena, vpliv na hemolitično ali lipidemično plazmo ni prikazan, učinek matriksa prikazan pri 4 različnih serijah plazme).
English: The quality of the bio-analytical report was checked internally by the MAH and was considered to be of good quality, based on the guideline applicable at that time (“Guideline for Industry - Bioanalytical Method Validation”, May 2001).
Slovenian: Kakovost bioanalitičnega poročila je imetnik dovoljenja za promet z zdravilom preveril interno in je menil, da je dobra, kar je temeljilo na smernici, ki je veljala v tistem času („Guideline for Industry - Bioanalytical Method Validation“ - Smernica za stroko - validacija bioanalitične metode, maj 2001).
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Cilazapril Teva and associated names, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Slovenian: je odbor priporočil začasen umik dovoljenj za promet z zdravilom Cilazapril Teva in povezanimi imeni v skladu s členom 116 Direktive 2001/83/ES, ker a. razmerje med tveganji in koristmi ni pozitivno ter b. podatki, ki naj bi podprli vlogo v skladu s členom 10 Direktive 2001/83/ES, niso pravilni.
English: The MAH stated that the calculated f2 values indicated dissolution similarity between the drug products in all three media, and therefore considered the probability of the drug being released in the stomach to be high.
Slovenian: Imetnik dovoljenja za promet z zdravilom je navedel, da so izračunane vrednosti f2 pokazale podobno raztapljanje med zdraviloma v vseh treh sredstvih, zato je verjetnost, da se bo zdravilo sprostilo v želodcu, velika.
English: The CHMP was of the opinion that the previous conclusions regarding bioequivalence will need to be confirmed by repeating the bioequivalence study.
Slovenian: Odbor CHMP je menil, da bo treba prejšnje zaključke glede biološke enakovrednosti potrditi s ponovno izvedbo študije biološke enakovrednosti.
English: The resulting solution is not expected to precipitate at higher pH values later in the intestine, due to the good aqueous solubility of the compound.
Slovenian: Ni pričakovati, da se bo nastala raztopina oborila pozneje v črevesu pri večjih vrednostih pH, saj je spojina dobro topna v vodi.
English: The CHMP therefore recommended the suspension of the marketing authorisations until adequate bioequivalence data is made available.
Slovenian: Odbor CHMP je zato predlagal začasni umik dovoljenj za promet z zdravilom, dokler ustrezni podatki o biološki enakovrednosti ne bodo na voljo.
English: The CHMP considered that these results could not be extrapolated to confirm the reliability of the pivotal bioequivalence study 2005-980.
Slovenian: Odbor CHMP je menil, da teh podatkov ni mogoče ekstrapolirati, s čimer bi se lahko potrdila zanesljivost ključne študije biološke enakovrednosti 2005-980.
English: The CHMP also noted the PSUR data, which did not indicate any safety concerns; however this is insufficient to confirm the bioequivalence of the product.
Slovenian: Odbor CHMP je pregledal tudi podatke v poročilu PSUR, v katerih ni izpostavljenih nobenih varnostnih težav, vendar to ni bilo zadostno za potrditev biološke enakovrednosti zdravila.
English: The initial marketing authorisations applications for the Cilazapril Teva tablets were supported by a single pivotal bioequivalence study (Study 2005-980), comparing Cilazapril Teva with the EU reference product Vascace, for which samples were analysed by BA Research International (now Cetero Research) between May 26th 2005 and December 20th 2005.
Slovenian: Prvotne vloge za dovoljenje za promet z zdravilom Cilazapril Teva tablete so bile podprte z eno ključno študijo biološke enakovrednosti (študijo 2005-980), v kateri so zdravilo Cilazapril Teva primerjali z referenčnim zdravilom v EU Vascace, pri čemer je vzorce analizirala družba BA Research International (zdaj Cetero Research) med 26. majem 2005 in 20. decembrom 2005.
English: The CHMP was requested to assess whether the deficiencies in conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) have impact on the benefit/risk of the concerned medicinal products and to give its opinion on whether the marketing authorisations for authorised medicinal products for which studies have been carried out or samples analysed by Cetero Research, during the identified time period, should be maintained, varied, suspended or withdrawn.
Slovenian: Odbor CHMP so zaprosili za oceno o tem, ali pomanjkljivosti v izvedbi bioanalitičnih študij, opravljenih v ustanovi Cetero Research v Houstonu (Teksas, ZDA), vplivajo na razmerje med tveganji in koristmi pri uporabi zadevnih zdravil, ter za mnenje o tem, ali je treba dovoljenja za promet z odobrenimi zdravili, za katera so bile v ustanovi Cetero Research v navedenem časovnem obdobju opravljene študije ali analizirani vzorci, ohraniti, spremeniti, začasno umakniti ali ukiniti.
English: The MAH also referred to comparative dissolution data for the Cilazapril Teva tablets and the reference product, using three different dissolution media (0.1 N HCl, pH 4.5 acetate buffer and pH 6.8 phosphate buffer).
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil tudi primerjalne podatke o raztapljanju zdravila Cilazapril Teva tablete in referenčnega zdravila, pri čemer so bila uporabljena tri različna sredstva za raztapljanje (0,1 N HCl, pH 4,5 acetatni pufer in pH 6,8 fosfatni pufer).
English: Therefore, given the serious doubts regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study 2005-980, submitted in support of the marketing authorisation, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Cilazapril Teva to its EU reference product, the CHMP was unable to conclude on the bioequivalence of Cilazapril Teva.
Slovenian: Zaradi resnih pomislekov glede zanesljivosti in pravilnosti podatkov iz kritične, ključne študije biološke enakovrednosti 2005-980, predložene kot podpora za dovoljenje za promet z zdravilom, in zaradi odsotnosti zanesljive študije biološke enakovrednosti, posebej zasnovane za ugotavljanje biološke enakovrednosti zdravila Cilazapril Teva in referenčnega zdravila v EU, odbor CHMP ni mogel sklepati o biološki enakovrednosti zdravila Cilazapril Teva.