FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP recommendation was sent to the European Commission which endorsed it and adopted a legally-binding decision throughout the European Union (EU) on 24 June 2013.
Croatian: Preporuka CHMP poslana je Europskoj komisiji koja ju je potvrdila i usvojila kao pravno obvezujuću širom Europske unije (EU) 24. lipnja 2013.
English: Detailed recommendations for patients and healthcare professionals are available below.
Croatian: Detaljnije preporuke za bolesnike i zdravstvene djelatnike dostupne su u nastavku.
English: Although the design and early termination of the study limit the conclusions that can be drawn, these results provide some reassurance with regard to cardiovascular safety of cilostazol.
Croatian: Iako dizajn i prijevremeni završetak ispitivanja ograničava moguće zaključke, ti rezultati ipak donekle umiruju glede kardiovaskularne sigurnosti cilostazola.
English: Medicines containing cilostazol have been approved in the EU through national procedures since 2000 and are available in France, Germany, Italy, Spain, Sweden and the United Kingdom under the invented names Pletal and Ekistol.
Croatian: Lijekovi koji sadrže cilostazol odobreni su u EU nacionalnim postupkom od 2000. godine te su dostupni u Francuskoj, Njemačkoj, Italiji, Španjolskoj, Švedskoj i Ujedinjenom Kraljevstvu pod zaštićenim nazivima Pletal i Ekistol.
English: • Cilostazol should only be used for intermittent claudication when lifestyle changes (including smoking cessation and exercise programmes) and other appropriate interventions alone have not produced adequate benefit.
Croatian: • Cilostazol treba koristiti samo za intermitentnu klaudikaciju kada promjene načina života (uključujući prestanaka pušenja i programe tjelovježbe) te druge odgovarajuće intervencije same nisu dovele do odgovarajuće dobrobiti.
English: More information on the studies and the CHMP's conclusions is available below.
Croatian: Više informacija o ispitivanjima i zaključcima CHMP dostupni su u nastavku.
English: Blocking the enzyme reduces these actions and blood flow is improved, allowing patients to walk further without disabling pain.
Croatian: Blokiranjem enzima smanjuju se ova djelovanja i poboljšava protok krvi što omogućava bolesnicima da hodaju dulje bez onesposobljavajuće boli.
English: Many of the patients who were prescribed the medicine were much older, and taking more medicines, than those in whom it was originally tested before marketing, which may explain the increased risk of side effects.
Croatian: Mnogi od bolesnika kojima je propisan lijek bili su puno stariji i uzimali su više lijekova od bolesnika na kojim je lijek ispitan prije puštanja u promet što može objasniti povećani rizik od nuspojava.
English: • Treatment should only be started by physicians experienced in the management of intermittent claudication, and should be reviewed after three months.
Croatian: • Liječenje treba započeti samo liječnik iskusan u liječenju intermitentne klaudikacije te je potrebna procjena nakon tri mjeseca.
English: When a composite endpoint of cardiac morbidity (coronary and cerebrovascular events) and mortality was considered, there were 135 events with cilostazol and 153 with placebo.
Croatian: Kad se uzmu u obzir kompozitni ishod srčanog komorbiditeta (koronarni i cerebrovaskularni događaji) i mortalitet, bilo je 135 događaja s cilostazolom i 153 s placebom.
English: CHMP concluded that the magnitude of benefit was clinically important in a subgroup of patients, and that response can be adequately assessed after three months of treatment.
Croatian: CHMP je zaključilo da je snaga dobrobiti bili klinički značajna u podskupini bolesnika i da se odgovor može odgovarajuće procijeniti nakon tri mjeseca liječenja.
English: The trial, which examined all-cause mortality as a primary endpoint, was terminated early (after about 3 years) because of a high drop-out rate in both groups (397 out of 721 cilostazol patients and 391 out of 718 patients taking placebo) and because of a much lower mortality rate than expected.
Croatian: Ispitivanje koje je pregledalo sve uzroke mortaliteta kao primarni ishod dovršeno je ranije (otprilike nakon 3 godine) zbog visoke stope izostanaka u boje skupine (397 od 721 bolesnika koji su primali cilostazol i 391 od 718 bolesnika koji su uzimali placebo) i zbog puno niže stope mortaliteta od očekivane.
English: • Safety data from nearly 14,000 suspected adverse drug reaction reports (in the context of over 6 million patient years' exposure worldwide) and 4,000 events in non-interventional studies confirmed the known adverse effect profile of cilostazol from clinical trials.
Croatian: • Sigurnosni podaci od približno 14 000 izvješća o sumnjama na nuspojave (u sklopu izloženosti od 6 milijuna bolesničkih godina širom svijeta) i 4000 događaja u neintervencijskim ispitivanjima potvrdilo je profil štetnih učinaka cilostazola poznat iz kliničkih ispitivanja.
English: • Prescribers should be aware of the risk of interactions with cilostazol; its dose should be reduced in patients also taking strong inhibitors of CYP3A4 or CYP2C19.
Croatian: • Propisivači trebaju biti svjesni rizika od interakcija s cilostazolom; njegovu dozu također treba smanjiti u bolesnika koji uzimaju snažne inhibitore CY3A4 ili CY2C19.
English: Although suspected adverse drug reaction reports have raised some safety concerns, these have not been substantiated in the clinical trial data (including the CASTLE study), and it remains possible to exclude high-risk patients in clinical practice.
Croatian: Iako je sumnja na nuspojave uzrokovala zabrinutost, te nuspojave nisu bile znatnije izražene u podacima iz kliničkih ispitivanja (uključujući ispitivanje CASTLE) te ostaje mogućnost isključivanja visoko rizičnih bolesnika iz kliničke prakse.
English: On 22 March 2013 the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) recommended that the use of cilostazol-containing medicines in the treatment of intermittent claudication - a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk - should be restricted with a range of new measures aimed at targeting a patient population in which there are clinical benefits, and at the same time minimising important risks.
Croatian: Dana 22. ožujka 2013. godine Povjerenstvo za humane lijekove Agencije za lijekove i medicinske proizvode (CHMP) preporučilo je da se upotreba lijekova koji sadrže cilostazol u liječenju intermitentne klaudikacije - stanja u kojem slaba opskrba krvlju mišića nogu uzrokuje bol i utječe na sposobnost hodanja - treba ograničiti unutar raspona novih mjera usmjerenih ka ciljnoj populaciji bolesnika kod kojih postoje kliničke dobrobiti, a u isto se vrijeme minimiziraju važni rizici.
English: The Committee recommended that cilostazol should only be used in patients whose symptoms have not improved despite prior lifestyle changes such as exercise, healthy diet and stopping smoking.
Croatian: Povjerenstvo je preporučilo da se cilostazol koristi samo kod bolesnika čiji se simptomi nisu poboljšali unatoč prethodnim promjenama načina života poput tjelovježbe i zdrave prehrane i prestanka pušenja.
English: • Other healthcare professionals should refer patients to the prescribing physician as appropriate.
Croatian: • Drugi propisivači trebaju uputiti bolesnike liječniku propisivaču prema potrebi.
English: The recommendations followed a review of current evidence which indicated that the modest benefits of these medicines, i.e. their ability to increase the distance patients are able to walk, are only greater than their risks, in particular the risks of side effects affecting the heart or serious bleeding, in a limited subgroup of patients.
Croatian: Preporuke su uslijedile nakon procjene aktualnih dokaza koji su ukazivali da su samo umjerene dobrobiti ovih lijekova, tj. njihova sposobnost povećanja hodne pruge bolesnika veće od njihovih rizika, a posebice od rizika od nastanka nuspojava koje utječu na srce ili rizika od ozbiljnog krvarenja, u ograničenoj podskupini bolesnika.
English: The CHMP examined available clinical trial data on the benefits and risks of the medicines provided by the companies that market these medicines, as well as data from scientific literature, reports of suspected side effects, post-marketing studies and experimental studies before making its recommendations.
Croatian: CHMP je pregledalo dostupne podatke iz kliničkih ispitivanja o dobrobitima i rizicima lijekova koje isporučuju tvrtke koje trže te lijekove kao i podatke iz znanstvene literature, izvješća o sumnjama na nuspojave, ispitivanja nakon stavljanja lijeka u promet te eksperimentalnih ispitivanja prije donošenja preporuka.
English: However the evidence suggests that cilostazol alone, or in combination with one other antiplatelet drug, does not increase the risk of bleeding.
Croatian: Međutim, dokaz ukazuje da sam cilostazol ili u kombinaciji s jednim drugim lijekom protiv agregacije trombocita, ne povećava rizik od krvarenja.
English: The advice will vary for each patient depending on factors such as lifestyle options that could improve your condition, whether your walking symptoms have improved since you started cilostazol, whether you have had recent heart problems, and which other medicines you are taking.
Croatian: Savjet će se razlikovati za svakog bolesnika ovisno o čimbenicima poput odabira načina života koji bi mogli poboljšati vaše stanje bez obzira jesu li se Vaši simptomi hoda poboljšali otkad uzimate cilostazol, bez obzira jeste li nedavno imali problema sa srcem te uz razmatranje drugih lijekova koje uzimate.
English: If you are taking cilostazol-containing medicines, you should make a non-urgent appointment with your doctor to review your treatment.
Croatian: Ako uzimate lijekove koji sadrže cilostazol trebate zakazati redoviti sastanak sa svojim liječnikom kako bi se procijenila Vaša terapija.
English: The request followed reports to the Spanish agency of serious adverse effects affecting the heart including fatal heart attacks, angina and arrhythmias (irregular heartbeat) as well as cases of serious bleeding including bleeding in the brain.
Croatian: Zahtjev je slijedio izvješća španjolske agencije za ozbiljne nuspojave koje zahvaćaju srce uključujući smrtonosne srčane udare, anginu i aritmije (nepravilne otkucaje srca) kao i slučajeve ozbiljnog krvarenja uključujući krvarenje u mozak.
English: Cilostazol-containing medicines are available in the EU under the names Pletal and Ekistol.
Croatian: Lijekovi koji sadrže cilostazol dostupni su u EU pod nazivima Pletal i Ekistol.
English: CHMP therefore recommended a number of measures aimed at targeting use of cilostazol to the population most likely to benefit, and in whom the risk of side effects is low.
Croatian: CHMP stoga preporučuje brojne mjere usmjerene ciljnoj uporabi cilostazola u populaciji za koju je najvjerojatnije da će od njega imati koristi te kod koje je rizik od nuspojava nizak.
English: • Cilostazol is used to treat intermittent claudication, a condition where walking becomes painful and difficult because of problems with blood circulation in the arteries of the legs.
Croatian: • Cilostazol se koristi za liječenje intermitentne klaudikacije, stanja u kojem hodanje postaje bolno i otežano zbog problema s cirkulacijom krvi u arterijama nogu.
English: • Cilostazol should not be given to patients who have unstable angina or who have had myocardial infarction or a coronary intervention (PCI) within the last six months, nor to those with a history of severe tachyarrhythmia.
Croatian: • Cilostazol se ne smije davati bolesnicima koji su imali nestabilnu anginu ili infarkt miokarda ili koronarnu intervenciju (PCI) unutar posljednjih 6 mjeseci niti onima koji imaju anamnezu teške tahiaritmije.
English: • Analysis of available data suggests an increased risk of haemorrhage when cilostazol is given to patients also taking both aspirin and clopidogrel.
Croatian: • Analiza dostupnih podataka ukazuje na povećani rizik od krvarenja kad se cilostazol daje bolesnicima koji također uzimaju i aspirin i klopidogrel.
English: • Long-term cardiovascular safety of cilostazol was examined post-marketing in the CASTLE study1, a randomised double-blind placebo controlled study involving 1,439 patients given cilostazol 100 mg twice daily (reduced to 50 mg twice daily if necessary) or placebo.
Croatian: • Dugoročna kardiovaskularna sigurnost cilostazola ispitana je nakon stavljanja lijeka u promet u ispitivanju CASTLE1, randomiziranom, dvostruko slijepom ispitivanju kontroliranom placebom koje uključuje 1439 bolesnika koji su primali cilostazol 100 mg dva puta dnevno (smanjeno na 50 mg dva puta dnevno ako je potrebno) ili placebo.
English: The Spanish Agency for Medicines and Health Products (AEMPS) asked the CHMP to carry out a full assessment of the benefit-risk balance of cilostazol and to issue an opinion on whether the marketing authorisations for products containing cilostazol should be maintained, varied, suspended or withdrawn across the EU.
Croatian: Španjolska agencija za lijekove i medicinske proizvode (AEMPS) zatražila je od CHMP da provede punu procjenu omjera dobrobiti i rizika cilostazola i da izda mišljenje o tome da li je potrebno održati, promijeniti, suspendirati ili povući Odobrenje za stavljanje lijeka u promet širom EU.
English: There were 49 deaths in the cilostazol group, of which 12 were due to cardiac disorders, and 52 in the placebo group (13 cardiac).
Croatian: Bilo je 49 smrti u skupini koja je primala cilostazol od kojih je 12 bilo zbog srčanih poremećaja, a 52 smrti u skupini koja je primala placebo (13 ispitanika umrlo je od srca).
English: The Spanish Agency for Medicines and Health Products (AEMPS) asked the CHMP to carry out a review of these medicines following a number of reports of serious suspected side effects, in particular affecting the heart, as well as cases of serious bleeding.
Croatian: Španjolska agencija za lijekove i medicinske proizvode (AEMPS) zatražila je od CHMP da provede procjenu ovih lijekova nakon brojnih izvješća o sumnji na ozbiljne nuspojave posebice one koje zahvaćaju srce kao i slučajeve ozbiljnog krvarenja.
English: For the full changes to information for doctors and patients, see under the ‘All documents' tab.
Croatian: Za potpuni popis promjena informacija za liječnike i bolesnike pogledajte karticu
English: Cilostazol works by blocking an enzyme called phosphodiesterase type 3, which is found in the walls of arteries and is involved in various processes affecting circulation, including aggregation (clumping together) of blood platelets and narrowing of the arteries.
Croatian: Cilostazol djeluje blokadom enzima zvanog fosfosiesteraza 3 koja je nađena u stijenkama arterija i koja je uključena u brojne procese koji utječu na cirkulaciju, uključujući agregaciju (grupiranje) trombocita i sužavanje arterija.
English: Doctors should review their patients at their next routine appointment and assess the continued suitability of cilostazol treatment.
Croatian: Liječnici trebaju procijeniti svoje bolesnike prilikom njihove sljedeće rutinske kontrole te ocijeniti je li nastavak liječenja cilostazolom održiv ili ne.
English: In conclusion, the CHMP considered that although on average the efficacy of cilostazol is modest, there is a small group of patients in whom it is of clinical relevance, not least in helping them to begin exercise programmes.
Croatian: Kao zaključak, CHMP je smatrao da je iako u prosjeku djelotvornost cilostazola umjerena, postoji mala skupina bolesnika kod kojih taj lijek ima klinički značaj, barem kao pripomoć u programu tjelovježbe.
English: • Cilostazol has been shown to produce modest increases in walking distance compared with placebo; meta-analysis of pooled individual patient data from nine efficacy trials involving 3,122 patients indicated a mean percentage increase from baseline of 59.4% for cilostazol, compared with 24.3% for placebo.
Croatian: • Dokazano je da cilostazol uzrokuje skromni porast hodne pruge u usporedbi s placebom; meta analize udruženih podataka pojedinih bolesnika iz devet ispitivanja djelotvornosti koja su uključivala 3122 bolesnika ukazala su na prosječni postotak porasta u odnosu na početne vrijednosti od 59,4% za cilostazol u usporedbi s 24,3% za placebo.
English: The Agency's recommendations are based on a review by the Committee for Medicinal Products for Human Use (CHMP), which looked at available data on the benefits and risks of cilostazol.
Croatian: Više informacija o procjeni: Preporuke Agencije temelje se na procjeni Povjerenstva za humane lijekove (CHMP) koje je potražilo dostupne podatke i dobrobitima i rizicima cilostazola.
English: • Cilostazol should also not be given to patients also receiving both aspirin and clopidogrel, or any other combination of two or more additional antiplatelet or anticoagulant medicines.
Croatian: • Cilostazol se također ne smije davati bolesnicima koji primaju i aspirin i klopidogrel ili bilo koju drugu kombinaciju dva ili više dodatnih lijekova protiv agregacije trombocita ili koagulacije.
English: In addition, cilostazol-containing medicines should not be used in patients who have suffered severe tachyarrhythmia (fast, abnormal heart rhythm), or recent unstable angina, heart attack or bypass surgery, or who take two or more antiplatelet or anticoagulant medicines such as aspirin and clopidogrel.
Croatian: Osim toga, lijekovi koji sadrže cilastazol ne smiju se koristiti u bolesnika koji su pretrpjeli tešku tahiaritmiju (nenormalni, ubrzani srčani ritam) ili nedavnu nestabilnu anginu, srčani udar ili kirurški zahvat ugradnje premosnice ili koji uzimaju dva ili više lijekova protiv zgrušavanja krvi ili agregacije trombocita poput aspirina i klopidogrela.
English: Cilostazol is a medicine that is used to improve walking distance in patients who have intermittent claudication due to peripheral arterial obstructive disease (obstruction and narrowing of the arteries of the limbs, leading to reduced blood flow).
Croatian: Cilostazol je lijek koji se koristi za poboljšavanje hodne pruge u bolesnika s intermitentnom klaudikacijom uzrokovanom opstruktivnom bolešću perifernih arterija (opstrukcija i sužavanje arterija udova što uzrokuje reducirani protok krvi).
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/16/1137/001 Granpidam 20 mg Film-coated tablet
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene
English: - if you are a young adult.
Croatian: − ako ste mlada odrasla odoba.
English: Most of them occurred during the first months of treatment.
Croatian: Većina njih se dogodila tijekom prvih mjeseci liječenja.
English: Just carry on with the next dose at the usual time.
Croatian: Samo nastavite uzimati sljedeću dozu u uobičajeno vrijeme.
English: It belongs to a group of medicines called antidepressants.
Croatian: Pripada skupini lijekova koji se nazivaju antidepresivi.
English: Date of latest renewal : 12 December 2018
Croatian: Datum posljednje obnove odobrenja: 12. prosinca 2018.
English: Surveillance of the liver function (see also section 2):
Croatian: Praćenje funkcije jetre (vidjeti također dio 2):
English: Depression is a continuing disturbance of mood that interferes with everyday life.
Croatian: Depresija je kontinuirani poremećaj raspoloženja koji utječe na svakodnevan život.
English: You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Croatian: Možete ih zamoliti da Vam kažu ako misle da Vam se depresija pogoršava ili ako su zabrinuti zbog promjena u Vašem ponašanju.
English: You should swallow your tablet with a drink of water.
Croatian: Tabletu trebate progutati s malo vode.
English: Thereafter tests will be taken if the doctor finds it necessary.
Croatian: Nakon toga će se pretrage raditi ako liječnik procjeni da je to potrebno.
English: Suicide/suicidal thoughts
Croatian: Suicid/suicidalne misli
English: If you take more Valdoxan than you should
Croatian: Ako uzmete više Valdoxana nego što ste trebali
English: These effects are usually mild to moderate and disappear spontaneously within a few days.
Croatian: Ovi učinci su obično blagi do umjereni i spontano nestaju unutar nekoliko dana.
English: You must not use Valdoxan if your liver does not work properly.
Croatian: Ne smijete koristiti Valdoxan ako Vaša jetra ne radi dobro.
English: Use in elderly with dementia
Croatian: Primjena kod starijih osoba s demencijom
English: Make sure that your reactions are normal before driving or operating machines.
Croatian: Provjerite jesu li Vaše reakcije normalne prije upravljanja vozilom ili strojevima.
English: Agitation and related symptoms* (such as irritability and restlessness) Aggression*
Croatian: Agitacija i povezani simptomi* (kao što su razdražljivost i nemir) Agresija*
English: Aluminium/PVC blister packed in cardboard boxes.
Croatian: Aluminij/PVC blister pakiran u kartonskoj kutiji.
English: The Patient's Booklet should contain the following key messages:
Croatian: Knjižica za bolesnike mora sadržavati sljedeće ključne poruke:
English: Urinary retention*
Croatian: Urinarna retencija*
English: You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet.
Croatian: Možda će Vam pomoći ako kažete rođaku ili bliskom prijatelju da ste depresivni te ih zamolite da pročitaju ovu uputu.
English: Anpharm Przedsiebiorstwo Farmaceutyczne S.A. 03-236 Warszawa ul.
Croatian: Anpharm Przedsiebiorstwo Farmaceutyczne S.A. 03-236 Varšava ul.
English: The bioavailability is increased in women compared to men.
Croatian: Bioraspoloživost je povećana kod žena u usporedbi s muškarcima.
English: Valdoxan can be taken with or without food.
Croatian: Valdoxan se može uzimati sa ili bez hrane.
English: Electroconvulsive therapy (ECT)
Croatian: Elektrokonvulzivna terapija (EKT)
English: Absolute bioavailability is low (< 5% at the therapeutic oral dose) and the interindividual variability is substantial.
Croatian: Apsolutna bioraspoloživost je niska (< 5% pri terapijskoj peroralnoj dozi) te je značajna interindividualna varijabilnost.
English: These adverse reactions were usually transient and did not generally lead to cessation of therapy.
Croatian: Ove nuspojave obično su bile prolazne i uglavnom nisu uzrokovale prestanak terapije.
English: They usually occur within the first two weeks of the treatment and are usually temporary.
Croatian: One se obično pojavljuju unutar prva dva tjedna liječenja i obično su prolazne.
English: Valdoxan should not be used in children and adolescents (under 18 years old).
Croatian: Valdoxan se ne smije primjenjivati u djece i adolescenata (mlađih od 18 godina)
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Croatian: Kliničko iskustvo pokazuje da se rizik pojave suicida može povećati tijekom ranog stadija oporavka.
English: Your doctor may continue to give you Valdoxan when you are feeling better to prevent your depression from returning.
Croatian: Liječnik Vam može nastaviti davati Valdoxan i kada se osjećate bolje kako bi se spriječio povratak depresije.
English: Management of overdose should consist of treatment of clinical symptoms and routine monitoring.
Croatian: Zbrinjavanje predoziranja sastoji se od liječenja kliničkih simptoma i rutinskog praćenja.
English: Dizziness Somnolence Insomnia
Croatian: Omaglica Somnolencija Nesanica
English: Agomelatine does not alter daytime vigilance and memory in healthy volunteers.
Croatian: Agomelatin nije mijenjao dnevnu pozornost i pamćenje u zdravih dobrovoljaca.
English: One person having ingested 2,450 mg agomelatine, recovered spontaneously without cardiovascular and biological abnormalities.
Croatian: Jedna osoba koja je uzela 2 450 mg agomelatina spontano se oporavila bez kardiovaskularnih ili bioloških abnormalnosti.
English: The total number of patients receiving 50 mg was too low to draw any conclusions.
Croatian: Ukupan broj bolesnika koji su uzimali dozu od 50 mg bio je premalen za donošenje zaključka.
English: In healthy volunteers agomelatine preserved sexual function in comparison with paroxetine.
Croatian: Kod zdravih dobrovoljaca, agomelatin je sačuvao seksualnu funkciju u usporedbi s paroksetinom.