FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the median period of progression free survival for stage IB/II subjects treated with mogamulizumab was 4.7 months compared to 3.9 months for vorinostat-treated patients (Table 4).
Croatian: 4,7 mjeseca u usporedbi sa 3,9 mjeseci u bolesnika liječenih vorinostatom (Tablica 4).
English: These can include:
Croatian: Br. pod rizikom:
English: Breast-feeding
Croatian: POTELIGEO
English: Unopened vial 3 years
Croatian: 6.3 Rok valjanosti
English: - have human immunodeficiency virus (HIV), herpes, cytomegalovirus (CMV), or hepatitis B or
Croatian: - ako ste ikada imali tešku kožnu reakciju na ovaj lijek, - ako ste ikada imali reakciju na infuziju ovog lijeka (mogući simptomi reakcije na infuziju navedeni su u dijelu 4), - ako imate virus ljudske imunodeficijencije (HIV), herpes, citomegalovirus (CMV), ili infekciju virusom hepatitisa B ili C, ili druge trenutne infekcije,
English: Hypothyroidism
Croatian: Mogamulizumab
English: POTELIGEO is a clear, colourless solution.
Croatian: POTELIGEO je bistra, bezbojna otopina.
English: All remaining SOCs reported SADRs in one patient (0.3%).
Croatian: Za sve preostale organske sustav u klasifikaciji prijavljene su ozbiljne nuspojave u jednog bolesnika
English: It is currently available in the European Union (EU) in a number of different formulations.
Croatian: Trenutno je dostupan u Europskoj uniji (EU) u nizu različitih formulacija.
English: • If you have any questions, speak with your doctor or pharmacist.
Croatian: • Ako imate bilo kakvih pitanja, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: Further information about the EU-wide safety review:
Croatian: Daljnje informacije o sigurnosnom pregledu na razini EU-a:
English: 25 September 2013 EMA/592685/2013
Croatian: 25. rujna 2013. EMA/592685/2013
English: New measures aim to minimise cardiovascular risks
Croatian: Nove mjere za smanjivanje kardiovaskularnih rizika
English: New safety advice for diclofenac
Croatian: Novi sigurnosni savjeti za diklofenak
English: Limitations in the data had made it hard to quantify the risk initially, but a consistent picture was emerging by the time of the 2012 review.
Croatian: Ograničenja u podacima otežala su kvantifikaciju početnog rizika, no konzistentna slika stvorena je do pregleda provedenog 2012. godine.
English: • You should not stop taking your treatment without talking to your doctor.
Croatian: • Liječenje se ne smije prekinuti bez prethodnog savjetovanja s liječnikom.
English: Diclofenac is an NSAID.
Croatian: Diklofenak je NSAID.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Pregled ovih podataka prvo je provelo Povjerenstvo za procjenu rizika na području farmakovigilancije (PRAC-a).
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: CMDh, tijelo koje predstavlja države članice EU-a, odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene u nacionalnim postupcima na razini EU-a.
English: The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.
Croatian: Potreba za simptomatskim ublažavanjem i odgovor na terapiju bolesnika trebaju se periodički ponovno ocjenjivati.
English: • The effectiveness of diclofenac is well established.
Croatian: • Djelotvornost diklofenaka dobro je utvrđena.
English: A class warning of this risk is in place and the product information for all NSAIDs recommends that these medicines be used at the lowest effective dose for the shortest period of time necessary to control symptoms.
Croatian: Upozorenje za klasu ovog rizika je na snazi i informacije o proizvodu za sve NSAID-ove preporučaju da se ti lijekovi koriste u najmanjim učinkovitim dozama tijekom najkraćeg vremenskog razdoblja potrebnog za kontrolu simptoma.
English: The review of systemic diclofenac was initiated on 31 October 2012 at the request of the United Kingdom medicines agency, under Article 31 of Directive 2001/83/EC.
Croatian: Pregled sistemskog diklofenaka pokrenut je dana 31. listopada 2012. na zahtjev agencije za lijekove Ujedinjene Kraljevine, sukladno članku 31. Direktive 2001/83/EC.
English: Diclofenac-containing medicines have been authorised by national approval procedures in the EU Member States and have been available for many years under a wide range of trade names.
Croatian: Lijekovi koji sadrže diklofenak odobreni su nacionalnim postupcima za odobravanje u državama članicama EU-a i dostupni su već dugi niz godina pod nizom različitih trgovačkih naziva.
English: The latter found that, compared with placebo, the risk of major vascular events was increased by about one third by a COX-2 inhibitor (rate ratio [RR] 1.37, 95% confidence interval [CI] 1.14-1.66; p=0.0009) or diclofenac (1.41, 1.12-1.78; p=0.0036), mainly due to an increase in major coronary events (coxibs: 1.76, 1.312.37; p=0.0001; diclofenac: 1.70, 1.19-2.41; p=0.0032).
Croatian: Potonjim je utvrđeno da je u usporedbi s placebom rizik od većih vaskularnih poremećaja povećan za otprilike jednu trećinu s inhibitorom COX-2 (omjer stope [RR] 1.37, 95% interval pouzdanosti [CI] 1.14-1.66; p=0.0009) ili diklofenakom (1.41, 1.12-1.78; p=0.0036), uglavnom uslijed povećanja ozbiljnijih koronarnih poremećaja (koksibi: 1.76, 1.31-2.37; p=0.0001; diklofenak: 1.70, 1.19-2.41; p=0.0032).
English: Since some prostaglandins are involved in causing pain and inflammation at sites of injury or damage in the body, a reduced production of prostaglandins reduces pain and inflammation.
Croatian: S obzirom na da su određeni prostaglandini uključeni u uzrokovanje boli i upala u mjestima ozljede ili oštećenja u tijelu, smanjenom proizvodnjom prostaglandina smanjuje se bol i upala.
English: The new advice aims to minimise the risks of effects on the heart and circulation from these medicines.
Croatian: Nove mjere usmjerene su na smanjivanje rizika učinka ovih lijekova na srce i cirkulaciju.
English: The product information will be amended and healthcare professionals prescribing or dispensing systemic diclofenac will receive further appropriate communication at a national level.
Croatian: Informacije o proizvodu bit će dopunjene, a zdravstveni djelatnici koji propisuju ili izdaju sistemski diklofenak zaprimit će daljnju odgovarajuću komunikaciju na nacionalnoj razini.
English: • In the light of the above, all patients receiving regular diclofenac therapy should be reviewed at the next scheduled appointment.
Croatian: • U svjetlu prethodno navedenog, svi bolesnici koji primaju redovitu terapiju diklofenaka moraju se pregledati pri sljedećem zakazanom pregledu.
English: The safety of NSAIDs has been closely monitored by regulatory authorities in the EU.
Croatian: Regulatorna tijela EU-a pozorno nadziru sigurnost NSAID-ova.
English: Diclofenac is effective in reducing inflammation and pain.
Croatian: Diklofenak je djelotvoran u smanjivanju upale i boli.
English: This applies particularly when diclofenac is used at a high dose and for long-term treatment.
Croatian: Ovo je posebice primjenjivo u slučajevima kada se diklofenak koristi u velikoj dozi i za dugotrajne terapije.
English: Most formulations are for systemic use (given as treatment throughout the body, such as oral and injectable medicines), which are covered by the current review.
Croatian: Većina formulacija su sistemske uporabe (i primjenjuju se kao terapija kroz cijelo tijelo, poput peroralnih lijekova i lijekova za injekciju), koji su obuhvaćeni trenutnim pregledom.
English: It belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs' (NSAIDs).
Croatian: Ubraja se u grupu lijekova „nestereoidni protuupalni lijekovi” (NSAR-ovi).
English: The CMDh position was sent to the European Commission, which confirmed it and took a final legally binding decision throughout the EU on 25 September 2013.
Croatian: Stav CMDh-a dostavljen je Europskoj komisiji, koja ga je potvrdila i usvojila kao konačnu pravno obvezujuću odluku na razini EU-a dana 25. rujna 2013.
English: • As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Croatian: • S obzirom na to da se kardiovaskularni rizici diklofenaka mogu povećati s dozom i dužim uzimanjem, trebaju se primjenjivati što je kraće moguće u najmanjoj djelotvornoj dnevnoj dozi.
English: The overall number of heart attacks in people at moderate risk would be expected to increase by around 3 cases per year for every 1,000 people treated with diclofenac (to 11 per 1,000 people per year).
Croatian: Očekuje se povećanje ukupnog broja infarkta miokarda u osoba izloženih umjerenom riziku za otprilike 3 slučaja godišnje na svakih 1.000 osoba koje se liječe diklofenakom (do 11 na 1.000 osoba godišnje).
English: • The risk with diclofenac is increased more if you are already at higher risk, so use is no longer recommended if you have already had a heart attack or stroke, or have heart failure, blockages to blood vessels to the heart or brain or an operation to clear or bypass such blockages, or circulatory problems that restrict blood flow to your limbs.
Croatian: • Rizik s diklofenakom povećava se još više ako ste već izloženi visokom riziku, tako da se uporaba više ne preporuča ako ste već imali infarkt miokarda, moždani udar ili srčani zastoj, začepljenja krvnih žila do srca ili mozga odnosno kirurški zahvat s ciljem uklanjanja ili premoštenja takvih začepljenja, ili problema sa cirkulacijom koji ograničavaju protok krvi do udova.
English: In addition to diclofenac, widely used NSAIDs also include ibuprofen and naproxen.
Croatian: Uz diklofenak, NSAID-ovi široke uporabe također uključuju ibuprofen i naproksen.
English: • If you have other risk factors such as high blood pressure, high blood cholesterol, diabetes, or if you smoke, your doctor will need to assess if you should use diclofenac and the best way to take it.
Croatian: • Ako imate druge faktore rizika poput visokog krvnog tlaka, visokog krvnog kolesterola, dijabetesa, ili ako pušite, Vaš liječnik treba ocijeniti trebate li uzimati diklofenak i najbolji način primjene.
English: The PRAC review of diclofenac was started at the request of the UK medicines regulatory agency, the MHRA, in October 2012 in response to findings from the 2012 review of NSAIDs.
Croatian: Postupak pregleda diklofenaka koji je proveo PRAC pokrenut je u listopadu 2012. na zahtjev regulatorne agencije za lijekove Ujedinjenog Kraljevstva (MHRA) u listopadu 2012. godine kao reakcija na nalaze iz 2012. utvrđena pregledom NSAID-ova.
English: As the CMDh position was adopted by majority it was sent to the European Commission, which confirmed it and took a final legally binding decision valid throughout the EU.
Croatian: S obzirom da je stav CMDh-a usvojen većinom glasova, dostavljen je Europskoj komisiji, koja ga je potvrdila i usvojila kao konačnu pravno obvezujuću odluku na razini EU-a.
English: As diclofenac-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Croatian: Lijekovi koji sadrže diklofenak odobreni su nacionalno, preporuke PRAC-a dostavljene su Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za lijekove za ljude (CMDh), koja je usvojila konačno mišljenje.
English: Overall, compared with placebo, allocation to diclofenac or a coxib caused around three additional major vascular events per 1,000 participants per year, with one such event causing death; in high-risk individuals, about seven or eight more would have a major vascular event, of which two would be fatal.
Croatian: Cjelokupno gledano, u usporedbi s placebom alokacija na doklofenak ili koksib uzrokovala je otprilike tri dodatna velika vaskularna poremećaja na 1.000 poremećaja godišnje, pri čemu je jedan takav poremećaj uzrokovao smrt; u slučaju visoko rizičnih pojedinaca, otprilike sedam ili osam osoba više imalo je ozbiljniji vaskularni poremećaj, od kojih su dva bila smrtonosna.
English: Traditional NSAIDs act by blocking the effects of the two cyclo-oxygenase (COX) enzymes, known as COX-1 and COX-2, resulting in a reduced production of substances called prostaglandins.
Croatian: Tradicionalni NSAID-i djeluju blokirajući učinke dva enzima ciklo-oksigenaze (COX), poznatih pod nazivima COX-1 i COX-2, što rezultira smanjenom proizvodnjom tvari naziva prostaglandina.
English: About 8 people in 1,000 at moderate risk of heart disease are likely to have a heart attack over one year.
Croatian: Kod otprilike 8 na 1.000 osoba izloženih umjerenom riziku od bolesti srca izgledno je da će doživjeti infarkt miokarda tijekom jedne godine.
English: The latest review by the PRAC was therefore initiated specifically to assess the benefit-risk of systemic diclofenac.
Croatian: Posljednji pregled PRAC-a je stoga pokrenut sa specifičnim ciljem ocjene omjera koristi i rizika sistemskog diklofenaka.
English: The cardiovascular risk with any NSAID depends on a person's underlying risk factors, such as high blood pressure and cholesterol levels and also any underlying heart or circulatory conditions.
Croatian: Kardiovaskularan rizik svakog NSAID-a ovisi o latentnim faktorima rizika osobe, poput primjerice visokog krvnog tlaka i razina kolesterola kao i bilo kojeg latentnog stanja srca ili cirkulacije.
English: • Use of diclofenac is contra-indicated in patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.
Croatian: • Uporaba diklofenaka kontraindicirana je u bolesnika s utvrđenom zastojnom insuficijencijom (NYHA klas II-IV), ishemičnom srčanom bolešću, perifernom arterijskom bolešću i cerebrovaskularnom bolešću.
English: A subgroup of NSAIDs, called ‘selective COX-2 inhibitors' (also known as ‘coxibs'), acts by blocking the COX-2 enzyme rather than both.
Croatian: Podgrupa NSAID-ova, naziva „selektivni inhibitori COX-2” (također poznati pod nazivom „coksibi”), djeluju blokirajući enzim COX-2, a ne oboje.
English: On 28 June 2013, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority new safety advice for diclofenac-containing medicines that are given by means such as capsules, tablets, suppositories or injections, intended to have an effect on the whole body (known as a systemic effect).
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za lijekove za ljude (CMDh) potvrdila je većinu novih sigurnosnih savjeta za lijekove koji sadrže diklofenak, a koji se primjenjuju u obliku kapsula, tableta, čepića ili injekcija, te su namjeni za djelovanje po cijelom tijelu (poznato pod nazivom sistemsko djelovanje).
English: Although the risk is likely to be dose-dependent, the PRAC considered that cardiovascular thrombotic risk cannot be excluded across all doses of diclofenac, especially in patients with pre-existing co-morbidities.
Croatian: Iako je izgledno da rizik ovisi o dozi, PRAC smatra da se kardiovaskularan trombotični rizik ne može isključiti u svim dozama diklofenaka, a posebice u bolesnika s prethodno postojećim komorbiditetima.
English: • If you are on long-term diclofenac treatment you will need to have your treatment reviewed to ensure that it is still right for you.
Croatian: • Ako Vas dugoročno liječe diklofenakom, liječenje se mora ponovno procijeniti kako bi se osiguralo je li to liječenje još uvijek najbolje rješenje za Vas.
English: As the risk is known to be somewhat higher with the subgroup of NSAIDs known as selective COX-2 inhibitors, increased measures to minimise risk are recommended in their product information.
Croatian: S obzirom da je poznato da postoji nešto veći rizik s podgrupom NSAID-ova poznatih pod nazivom selektivni inhibitori COX-2, povećane mjere za smanjivanje rizika preporučuju se u njihovim informacijama o proizvodu.
English: If 1,000 patients at moderate risk took diclofenac for a year, there would be about 3 extra cases of heart attack among them, compared with patients not taking diclofenac.
Croatian: Ako je 1.000 bolesnika izloženih umjerenom riziku uzimalo diklofenak tijekom godine dana, nastupila bi dodatna 3 slučaja infarkta miokarda u usporedbi s bolesnicima koji ne uzimaju diklofenak.
English: • Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
Croatian: • Bolesnici sa značajnim faktorima rizika za kardiovaskularne poremećaje (primjerice hipotenziju, hiperlipidemiju, dijabetes mellitus, pušenje) trebaju se nakon pažljivog razmatranja liječiti samo diklofenakom.
English: The CMDh agreed with the PRAC conclusion that although the benefits of systemic diclofenac still outweigh the risks, those risks were similar to the risks with COX-2 inhibitors, and it endorsed the recommendation that similar precautions should be applied.
Croatian: CMDh je suglasan sa zaključkom PRAC-a da iako koristi sistemskog diklofenaka još uvijek nadmašuju rizike, ti su rizici slični rizicima inhibitora COX-2, te je potvrdio preporuke da se slične mjere opreza moraju primijeniti.
English: The latter identified a small increased risk of these cardiovascular side effects with diclofenac compared with other NSAIDsan increase similar to that seen with the COX-2 inhibitors.
Croatian: Posljednji je identificirao malo povećani rizik ovih kardiovaskularnih nuspojava s diklofenakom u usporedbi s drugim NSAID-ovima - povećanje slično onome koje je uočeno s inhibitorima COX-2.
English: However, data from previous reviews carried out in 2005, 2006 and 2012 suggested an increased relative risk of arterial thromboembolic events which was sometimes greater than for other commonly prescribed NSAIDs and in some cases as great or greater than that seen with certain COX-2 inhibitors.
Croatian: No, podaci iz pregleda prethodno provedenih u 2005., 2006. i 2012. godini nagovješćuju povećani relativan rizik arterijsko tromboembolijskih poremećaja koji su u pojedinačnim slučajevima bili veći od rizika za druge često propisane NSAID-ove, a u pojedinim slučajevima podjednako velik ili veći od rizika uočenog s određenim inhibitorima COX-2.
English: Speak to your prescriber at your next scheduled appointment.
Croatian: Savjetujte se s liječnikom koji vam propisuje lijekove pri sljedećem zakazanom pregledu.
English: Diclofenac is authorised for the relief of pain and inflammation in a wide range of conditions, including arthritic conditions and acute musculoskeletal disorders.
Croatian: Diklofenak je odobren za ublažavanje boli i upale za široki raspon stanja, uključujući artritična stanja i akutne muskuloskeletalne poremećaje.
English: • Overall, the benefits of this medicine are greater than its risks, but there is a small risk of heart attack or stroke in patients taking systemic diclofenac regularly, especially at high doses (150 mg daily) and for long periods.
Croatian: • Sveukupno gledano, koristi ovog lijeka nadmašuju s njim povezane rizike, no postoji mali rizik od infarkta miokarda ili moždanog udara u bolesnika koji redovito primaju sistemski diklofenak, posebice u velikim dozama (150 mg dnevno) te tijekom dugih vremenski razdoblja.
English: Reviews of these medicines carried out in 2005, 2006 and 2012 have confirmed that NSAIDs as a class are associated with a small increased risk of arterial thromboembolic events (blood clots in the arteries) especially in patients with underlying heart or circulatory conditions or with certain cardiovascular risk factors, which in some cases has led to heart attack or stroke, particularly if used at high dose and for long periods.
Croatian: Pregledi ovih lijekova provedeni 2005., 2006. i 2012. godine potvrdili su da su NSAID-ovi kao klasa povezani s malim povećanim rizikom od arterijskih tromboembolijskih poremećaja (krvnih ugrušaka u arterijama), posebice u bolesnika s latentnim stanjima srca i cirkulacije ili s određenim kardiovaskularnim rizičnim faktorima, koji u određenim slučajevima mogu uzrokovati infarkt miokarda ili moždani udar, posebice u velikim dozama ili tijekom duljih vremenskih razdoblja.
English: • Clinical trial and epidemiological data consistently point towards an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150 mg daily) and in long-term treatment.
Croatian: • Klinička ispitivanja i epidemiološki podaci kontinuirano ukazuju na povećani rizik od arterijsko trombotičkih poremećaja (primjerice za infarkt miokarda ili moždani udar) povezanih s uporabom diklofenaka, posebice u velikoj dozi (150 mg dnevno) i pri dugotrajnom liječenju.
English: Diclofenac is a widely used medicine for relieving pain and inflammation, particularly in painful conditions such as arthritis.
Croatian: Diklofenak je lijek široke primjene za ublažavanje boli i upale, posebice u slučaju bolnih stanja poput artritisa.
English: However, considering that the cardiovascular risk with systemic diclofenac appears similar to that of selective COX-2 inhibitors, it was considered that any risk minimisation in place for COX-2 inhibitors with respect to cardiovascular risk should also apply to diclofenac.
Croatian: No, uzimajući u obzir da se kardiovaskularan rizik sa sistemskim diklofenakom čini sličan riziku selektivnih inhibitora COX-2, smatra se da se svaka mjera smanjivanja rizika određena za inhibitore COX-2 s obzirom na kardiovaskularne rizike mora primijeniti na diklofenak.
English: This followed a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) which found that the effects of systemic diclofenac on the heart and circulation are similar to those of selective COX-2 inhibitors, another group of painkillers.
Croatian: Nakon pregleda kojeg je provelo Povjerenstva za procjenu rizika na području farmakovigilancije (PRAC) pri Europskoj agenciji za lijekove utvrđeno je da je djelovanje sistemskog diklofenaka na srce i cirkulaciju slično djelovanju selektivnih inhibitora COX-2, druge grupe analgetika.
English: The PRAC therefore recommended that the same precautions already in place to minimise the risks of blood clots in the arteries with selective COX-2 inhibitors should be applied to diclofenac.
Croatian: Stoga je preporuka PRAC-a da se iste mjere opreza, koje se već primjenjuju za smanjivanje rizika od krvnih ugrušaka u arterijama selektivnim inhibitorima COX-2, primjene i na diklofenak.
English: • The PRAC has further reviewed available data including several new case-control and cohort studies, a post-hoc analysis of data from the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-term) programme,1 and a meta-analysis2 by the Coxib and traditional NSAID Trialists Collaboration which involved over 600 clinical trials.
Croatian: Multinational Etoricoxib and Diclofenac Arthritis Long-Term),1 i meta-analize2 provedene za tradicionalnu suradnju osoba koje sudjeluju u ispitivanju koksiba i NSAID-a, koje je uključivalo više od 600 kliničkih ispitivanja.
English: EU number
Croatian: Broj EU odobrenja Zaštićeno ime
English: Possible signs of severe allergic reaction may include:
Croatian: Mogući znakovi teške alergijske reakcije mogu uključivati:
English: Ask about ways to prevent dehydration.
Croatian: Pitajte na koje načine možete spriječiti dehidraciju.
English: Possible signs are listed in section 4 under ‘dehydration'.
Croatian: Mogući znakovi su navedeni u dijelu 4 pod ‘dehidracija'.
English: Date of latest renewal: 14 February 2019
Croatian: Datum posljednje obnove odobrenja: 14. veljače 2019.
English: If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.
Croatian: U slučaju propuštene doze, doza se treba uzeti čim se bolesnik sjeti; međutim, ne smije se uzeti dvostruka doza u istom danu.
English: Possible signs of losing too much fluid from your body are listed in section 4.
Croatian: Mogući znakovi prevelikog gubitka tekućine iz tijela navedeni su u dijelu 4.