FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Dectova, zanamivir, prevents the flu virus from spreading by blocking some of the enzymes on the surface of the virus called neuraminidases.
Croatian: Djelatna tvar u lijeku Dectova, zanamivir, sprječava širenje virusa gripe inhibiranjem djelovanja nekih enzima na površini virusa koji se nazivaju neuraminidaze.
English: The most common side effects with Dectova (which may affect up to 1 in 10 people) are diarrhoea, raised levels of transaminases (liver enzymes), liver injury and rash.
Croatian: Najčešće nuspojave lijeka Dectova (koje se mogu pojaviti u najviše 1 od 10 osoba) uključuju proljev, povećanu razinu transaminaza (jetrenih enzima), oštećenje jetre i osip.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dectova have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Dectova nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: It took around 5.1 days for symptoms to resolve or patients to leave the hospital with Dectova compared with 5.6 days with Tamiflu.
Croatian: Pri uzimanju lijeka Dectova bilo je potrebno oko 5,1 dan da se simptomi povuku ili da bolesnici napuste bolnicu, u usporedbi s 5,6 dana kad se uzimao lijek Tamiflu.
English: What is Dectova and what is it used for?
Croatian: Što je Dectova i za što se primjenjuje?
English: Evidence from laboratory and other clinical studies also supported the effectiveness of Dectova.
Croatian: Dokazi iz laboratorijskih i drugih kliničkih ispitivanja također su potkrijepili učinkovitost lijeka Dectova.
English: Dectova is expected to be effective against some flu strains that do not respond to other flu treatments.
Croatian: Očekuje se da je lijek Dectova učinkovit protiv nekih sojeva virusa gripe koji ne odgovaraju na druge načine liječenja gripe.
English: Dectova is given as an infusion (drip) into a vein.
Croatian: Dectova se daje putem infuzije (ukapavanja) u venu.
English: Although Tamiflu was used as the comparator, there is some uncertainty about how effective this medicine is in complicated influenza as it has not been compared with placebo (a dummy treatment) in hospitalised influenza patients.
Croatian: Iako se Tamiflu koristio kao usporedni lijek, nije u potpunosti poznato koliko je taj lijek učinkovit u slučajevima komplicirane gripe jer nije bio uspoređivan s placebom (prividnim liječenjem) u hospitaliziranih bolesnika oboljelih od gripe.
English: Dectova contains the active substance zanamivir.
Croatian: Dectova sadrži djelatnu tvar zanamivir.
English: Its side effects, the most important one being liver injury, are similar to those seen with Tamiflu.
Croatian: Njegove nuspojave, od kojih je najvažnije oštećenje jetre, slične su onima zabilježenim pri primjeni lijeka Tamiflu.
English: Other information about Dectova
Croatian: Ostale informacije o lijeku Dectova
English: However, because uncertainties remain about the size of the effect of Tamiflu (and by extension the size of Dectova's effect), Dectova has been authorised under ‘exceptional circumstances'.
Croatian: Međutim, s obzirom na činjenicu da se snaga učinka lijeka Tamiflu (a stoga i snaga učinka lijeka Dectova) i dalje ne može točno procijeniti, lijek Dectova odobren je u „iznimnim okolnostima”.
English: Dectova works on neuraminidases of both influenza A (the most common type) and influenza B viruses.
Croatian: Dectova djeluje na neuraminidaze oba virusa, influence A (najčešćeg tipa) i influence B.
English: Dectova can only be obtained with a prescription.
Croatian: Dectova se izdaje samo na liječnički recept.
English: An overview of Dectova and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Dectova i zašto je odobren u EU-u
English: For more information about using Dectova, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Dectova pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: What are the risks associated with Dectova?
Croatian: Koji su rizici povezani s lijekom Dectova?
English: As for all medicines, data on the use of Dectova are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Dectova kontinuirano se prate.
English: Why is Dectova authorised in the EU?
Croatian: Zašto je lijek Dectova odobren u EU-u?
English: A main study showed that Dectova works as well as Tamiflu, with comparable time to discharge patients from hospital or resolution of most of the influenza symptoms.
Croatian: U glavnom ispitivanju utvrđeno je da Dectova djeluje jednako dobro kao Tamiflu s obzirom na to da je vrijeme potrebno za otpuštanje bolesnika iz bolnice ili za povlačenje većine simptoma gripe usporedivo.
English: What information is still awaited for Dectova?
Croatian: Koje se još informacije očekuju o lijeku Dectova?
English: Dectova is an antiviral medicine used to treat complicated and potentially life-threatening influenza (flu) caused by either the influenza A or B virus in adults and children from 6 months of age.
Croatian: Dectova je protuvirusni lijek koji se primjenjuje za liječenje komplicirane i potencijalno po život opasne influence (gripe) uzrokovane virusom gripe tipa
English: How does Dectova work?
Croatian: Kako djeluje Dectova?
English: What benefits of Dectova have been shown in studies?
Croatian: Koje su koristi od lijeka Dectova utvrđene u ispitivanjima?
English: How is Dectova used?
Croatian: Kako se Dectova primjenjuje?
English: Further evidence on benefits of Dectova comes from supporting clinical studies and other laboratory studies.
Croatian: Klinička ispitivanja i druga laboratorijska ispitivanja dodatno potvrđuju koristi od lijeka Dectova.
English: Dectova has been shown to work as well as Tamiflu (the standard of care for complicated flu) in one main study involving 626 patients who had been hospitalised.
Croatian: U jednom glavnom ispitivanju koje je obuhvatilo 626 hospitaliziranih bolesnika utvrđeno je da Dectova djeluje jednako dobro kao Tamiflu (standard skrbi za kompliciranu gripu).
English: 500 mg Powder for concentrate for solution for infusion
Croatian: 500 mg Prašak za koncentrat za otopinu za infuziju
English: Intravenous use vial (glass)
Croatian: Intravenska primjena bočica (staklo) 1 bočica
English: Pharmaceutical Form Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
English: 25 mg
Croatian: 120 tbleta
English: Tablet
Croatian: Farmaceutski oblik
English: Invented name Strength Pharmaceutical Form Route of administration
Croatian: Zaštićeno ime Doza
English: They are available under several trade names and in different formulations.
Croatian: Dostupni su pod nekoliko trgovačkih naziva i u različitim formulacijama.
English: This means that the medicine will no longer be available.
Croatian: To znači da taj lijek više neće biti dostupan.
English: The review of flupirtine was initiated on 26 October 2017 at the request of Germany, under Article 31 of Directive 2001/83/EC.
Croatian: Ocjenjivanje flupirtina pokrenuto je 26. listopada 2017. na zahtjev Njemačke, u skladu s člankom 31. Direktive 2001/83/EZ.
English: • Alternative treatment options are available.
Croatian: • Dostupna su alternativna rješenja za liječenje.
English: The opening of these channels reduces the excessive electrical activity that leads to many pain states.
Croatian: Otvaranje tih kanala smanjuje prekomjernu električnu aktivnost koja vodi u mnoga bolna stanja.
English: Flupirtine-containing medicines have been authorised since the 1980s and are currently available in the following EU Member States: Estonia, Germany, Latvia, Lithuania, Luxembourg, Poland, Portugal, and Slovakia.
Croatian: Lijekovi koji sadrže flupirtin odobreni su od 1980-tih godina i trenutačno su dostupni u sljedećim državama članicama EU-a: Estoniji, Njemačkoj, Latviji, Litvi, Luksemburgu, Poljskoj, Portugalu i Slovačkoj.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/153044/2018
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23. ožujka 2018.
English: • Healthcare professionals in the EU countries where flupirtine is marketed will receive a letter with detailed information on the appropriate actions to be taken, including when the medicine will become unavailable.
Croatian: • Zdravstveni radnici u zemljama EU-a na čijem se tržištu prodaje flupirtin dobit će dopis s detaljnim informacijama o odgovarajućim mjerama koje će se poduzeti, uključujući i datum nakon kojeg lijek više neće biti dostupan.
English: Flupirtine works as a ‘selective neuronal potassium channel opener'.
Croatian: Flupirtin djeluje kao „selektivan neuronski otvarač kalijevih kanala”.
English: Since the CMDh adopted its position by consensus, it will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Croatian: Budući da je CMDh svoje stajalište donio konsenzusom, izravno će ga provesti države članice u kojima su ti lijekovi odobreni u skladu s dogovorenim rasporedom.
English: This means that it opens specific pores on nerve cells called potassium channels.
Croatian: To znači da otvara specifične pore na površini živčanih stanica naziva kalijevi kanali.
English: • Patients with any questions should speak to their healthcare professional.
Croatian: • Bolesnici koji imaju bilo kakvih pitanja trebaju se obratiti liječniku koji skrbi o njihovu zdravlju.
English: It also assessed cases of serious liver damage reported since the 2013 review.
Croatian: Također je provedena procjena slučajeva ozbiljnog oštećenja jetre prijavljenih nakon ocjenjivanja iz 2013. godine.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Croatian: 1 CMDh je regulatorno tijelo za lijekove koje zastupa države članice Europske unije (EU), Island, Lihtenštajn i Norvešku.
English: • Healthcare professionals should consider alternative treatments for patients.
Croatian: • Zdravstveni radnici trebali bi razmotriti zamjensko liječenje bolesnika.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Croatian: Ocjenjivanje je prvotno proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za ocjenu sigurnosnih pitanja koja se odnose na lijekove za liječenje ljudi, koji je donio niz preporuka.
English: The CMDh therefore agreed that patients taking flupirtine-containing medicines continue to be exposed to serious risks which outweigh the benefits of these medicines.
Croatian: Stoga se CMDh složio da su bolesnici koji uzimaju lijekove koji sadrže flupirtin i dalje izloženi ozbiljnim rizicima koji nadmašuju koristi od tih lijekova.
English: • Restrictions introduced in 2013, which included limiting flupirtine use to two weeks and regular monitoring of liver function tests, have not been sufficiently followed in clinical practice.
Croatian: • Ograničenja uvedena u 2013. koja su obuhvaćala ograničenje primjene flupirtina na dva tjedna i redovito praćenje testova jetrene funkcije nisu se dostatno provodila u kliničkoj praksi.
English: In order to protect public health, the CMDh endorsed the PRAC recommendation to withdraw the marketing authorisations of flupirtinecontaining medicines.
Croatian: U cilju zaštite javnog zdravlja, CMDh je prihvatio preporuku PRAC-a za povlačenje odobrenja za stavljanje u promet lijekova koji sadrže flupirtin.
English: While the use of flupirtine-containing products has decreased, the measures implemented have not been effective at minimising the risk.
Croatian: Iako se primjena lijekova koji sadrže flupirtin smanjila, provedene mjere nisu bile učinkovite u svođenju rizika na najmanju moguću mjeru.
English: 2 These cases have been reported in the European database of suspected adverse drug reaction reports (Eudravigilance) between April 2013 and December 2017
Croatian: Ti slučajevi zabilježeni su između travnja 2013. i prosinca 2017. u europskoj bazi podataka prijava o mogućim nuspojavama lijekova (Eudravigilance).
English: The CMDh agreed with the PRAC conclusion that the restrictions introduced in 2013 have not been sufficiently followed, and cases of serious liver injury, including liver failure, still occurred.
Croatian: CMDh se složio sa zaključkom PRAC-a da se ograničenja uvedena u 2013. nisu dostatno provodila te je i dalje dolazilo do slučajeva ozbiljnog oštećenja jetre, uključujući zatajenje jetre.
English: The EMA recommendation was the outcome of a review of flupirtine medicines which was started because liver problems continued to be reported even after measures were introduced in 2013 to manage this risk.
Croatian: Preporuka EMA-e ishod je procjene lijekova koji sadrže flupirtin koje je pokrenuto jer su problemi s jetrom i dalje prijavljivani čak i nakon uvođenja mjera za upravljanje tim rizikom 2013.
English: The review, carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), looked at the available data including studies evaluating whether the 2013 restrictions were followed in clinical practice.
Croatian: Procjenu je proveo EMA-in Odbor za procjenu rizika u području farmakovigilancije (PRAC), te su pregledani dostupni podatci, uključujući ispitivanja koja su ocjenjivala provođenje ograničenja iz 2013. godine u kliničkoj praksi.
English: The CMDh1 has endorsed EMA's recommendation to withdraw the marketing authorisation for the pain medicine flupirtine, because of the risk of serious liver injury.
Croatian: CMDh1 je prihvatio preporuku EMA-e za povlačenje odobrenja za stavljanje u promet lijeka protiv boli flupirtina zbog rizika od ozbiljnog oštećenja jetre.
English: • Strict measures to try to reduce this risk were introduced in 2013 but have not been put into practice widely enough, and liver injury has continued to be reported.
Croatian: • U cilju smanjivanja tog rizika uvedene su stroge mjere u 2013. no njihova provedba nije bila dovoljno raširena te je oštećenje jetre i dalje prijavljivano.
English: • These medicines are being taken off the market in the EU because of a risk of serious liver injury.
Croatian: • Ti se lijekovi povlače s tržišta u EU-u zbog rizika od ozbiljnog oštećenja jetre.
English: Flupirtine is a medicine used to treat acute (short-lived) pain for up to 2 weeks, in patients who cannot use other painkillers such as opioids or nonsteroidal anti-inflammatory medicines (NSAIDs).
Croatian: Flupirtin je lijek koji se primjenjuje za liječenje akutne (kratkotrajne) boli najdulje do dva tjedna u bolesnika koji ne mogu uzimati druge analgetike poput opioida ili nesteroidnih protuupalnih lijekova (NSAID-ovi).
English: These measures had included limiting flupirtine use to no more than 2 weeks in patients with acute pain who could not use other painkillers, and carrying out weekly tests of liver function during treatment.
Croatian: Te su mjere uključivale ograničenje primjene flupirtina na najviše dva tjedna u bolesnika s akutnom boli koji ne mogu uzimati druge analgetike te provođenje testova jetrene funkcije jedanput tjedno tijekom liječenja.
English: • Flupirtine-containing medicines are being taken off the market in the EU because of the risk of serious liver injury.
Croatian: • Lijekovi koji sadrže flupirtin povlače se s tržišta u EU-u zbog rizika od ozbiljnog oštećenja jetre.
English: • Since 2013, cases of serious liver injury, including 23 cases of acute liver failure (sudden loss of liver function), some of which were fatal or led to transplantation have been reported following flupirtine use.
Croatian: • Slučajevi ozbiljnog oštećenja jetre izazvani primjenom flupirtina prijavljeni nakon 2013. uključivali su 23 slučaja akutnog zatajenja jetre (iznenadni gubitak jetrene funkcije), od kojih su neki bili sa smrtnim ishodom ili su rezultirali transplantacijom jetre.
English: Serious liver problems continued to be reported despite previous restrictions in use
Croatian: Unatoč prethodnim ograničenjima primjene i dalje su prijavljivani ozbiljni problemi s jetrom
English: • Flupirtine-containing medicines have been used to treat acute (short-term) pain for up to two weeks in adults who cannot use other painkillers (such as non-steroidal anti-inflammatory drugs (NSAIDs) and weak opioids).
Croatian: • Lijekovi koji sadrže flupirtin primjenjivali su se najdulje do dva tjedna za liječenje akutne (kratkotrajne) boli u odraslih osoba koje ne mogu uzimati druge analgetike (poput nesteroidnih protuupalnih lijekova (NSAID-ovi) i slabih opioida).
English: • Since 2013, cases of serious liver injury, including 23 cases of acute liver failure, some of which were fatal or led to transplantation have been reported following flupirtine use.2 The reactions are unpredictable and the exact mechanism by which flupirtine causes liver injury is not known.
Croatian: • Slučajevi ozbiljnog oštećenja jetre izazvani primjenom flupirtina prijavljeni nakon 2013. uključivali su 23 slučaja akutnog zatajenja jetre, od kojih su neki bili sa smrtnim ishodom ili su rezultirali transplantacijom jetre.2 Reakcije nisu predvidive i točan način na koji flupiritin uzrokuje oštećenje jetre nije poznat.
English: In addition, no further measures to reduce the risk of liver problems could be identified.
Croatian: Osim toga, nisu se mogle utvrditi dodatne mjere za smanjivanje rizika od problema s jetrom.
English: • In addition, no further measures to increase adherence to the restrictions nor adequately reduce the risk of liver problems could be identified.
Croatian: • Osim toga, nisu se mogle utvrditi dodatne mjere kojima bi se poboljšalo pridržavanje ograničenja ili dostatno smanjio rizik od problema s jetrom.
English: In addition, no further measures to increase adherence to the restrictions nor adequately reduce the risk of liver problems could be identified.
Croatian: Osim toga, nisu se mogle utvrditi dodatne mjere kojima bi se poboljšalo pridržavanje ograničenja ili dostatno smanjio rizik od problema s jetrom.
English: The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position on 21 March 2018.
Croatian: Preporuka PRAC-a poslana je Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja je donijela odluku 21. ožujka 2018. CMDh je regulatorno tijelo za lijekove koje zastupa države članice Europske unije (EU) te Island, Lihtenštajn i Norvešku.
English: • Six observational studies showed a lack of compliance with the measures that were introduced to minimise the risk of hepatotoxicity.
Croatian: • Nedostatak sukladnosti s mjerama uvedenima radi smanjenja rizika od hepatotoksičnosti na najmanju moguću mjeru zabilježen je u šest opservacijskih ispitivanja.
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that:
Croatian: Stoga je CHMP, u skladu s člancima 31. i 32. Direktive 2001/83/EZ, zaključio:
English: Grounds for CHMP opinion
Croatian: Razlozi za mišljenje CHMP-a
English: In view of the elements described above, BfArM considered that there was a need to take action at EU level.
Croatian: S obzirom na prethodno opisane okolnosti, BfArM je smatrao da je potrebno poduzeti mjere na razini EU-a.
English: Conclusions
Croatian: Zaključci
English: Riluzole
Croatian: Riluzol
English: Cefuroxime
Croatian: Cefuroksim
English: It has been highlighted that all the CAPAs agreed after the BfArM/IGZ inspection have been either implemented (for critical observations) or committed to (for other observations).
Croatian: Istaknuto je da su provedene sve korektivne i preventivne mjere dogovorene nakon inspekcije koju su proveli BfArM i IGZ (za kritična zapažanja) ili da je preuzeta obveza njihova provođenja (za druga zapažanja).
English: A later MHRA inspection (March 2016) has also resulted in one critical and 2 major observations, for which CAPAs have already been agreed with the inspectors.
Croatian: Kasnije provedena inspekcija MHRA-e (u ožujku 2016.) također je rezultirala jednim kritičnim i dvama značajnim zapažanjima, za koja su s inspektorima već bile dogovorene korektivne i preventivne mjere.
English: However, the CHMP is of the opinion that the absence of the identification of any pharmacovigilance signals does not provide sufficient reassurance because it is not established that the pharmacovigilance activities may be designed to detect such a signal.
Croatian: Međutim, CHMP je mišljenja kako činjenica da nisu utvrđeni nikakvi farmakovigilancijski signali nije dostatan razlog za otklanjanje sumnji jer nije utvrđeno da farmakovigilancijske aktivnosti mogu biti takve izvedbe da mogu otkriti takve signale.
English: Intentional misrepresentation of data happened at the site in two different trials performed in 2013 and 2014.
Croatian: Na toj su lokaciji podaci namjerno pogrešno predstavljeni u dvama različitim ispitivanjima koja su provedena u 2013. i 2014.
English: There was one general quality management system implemented at the site which included a quality assurance unit which was responsible for the clinical and the bioanalytical parts of the trial and which reported to the CEO of the facility.
Croatian: Na lokaciji je postojao jedan opći sustav upravljanja kvalitetom koji je obuhvaćao jedinicu za osiguravanje kvalitete koja je bila odgovorna za klinički i bioanalitički dio ispitivanja i koja je podnosila izvješća glavnom direktoru objekta.
English: Three bioequivalence trials, two performed in 2013 and one performed in 2014, were inspected.
Croatian: Pregledana su tri ispitivanja bioekvivalencije, dva provedena 2013. i jedno 2014.
English: The findings of the above mentioned inspection cast doubts on the reliability of the data of bioequivalence studies conducted between 2013 and 2014 at the site inspected.
Croatian: Nalazi tih inspekcija ukazuju na sumnju u pouzdanost podataka iz ispitivanja bioekvivalencije koja su provedena između 2013. i 2014. na lokaciji inspekcije.
English: Therefore BfArM considered that this affects the trustworthiness of the data generated by the site (clinical and bioanalytical) in the time period from the beginning of the first study in March 2013 until the date when the inspection took place in March 2015, as it must be assumed that critical deficiencies could not be detected by the quality management system at the site in the meantime, because corrective actions and preventive actions (CAPAs) were only implemented after the inspection.
Croatian: Stoga je BfArM smatrao da to utječe na pouzdanost podataka prikupljenih na toj lokaciji (kliničkih i bioanalitičkih) u vremenskom razdoblju od početka prvog ispitivanja u ožujku 2013. do datuma provođenja inspekcije u ožujku 2015. jer se mora pretpostaviti da sustav upravljanja kvalitetom u tom razdoblju nije mogao otkriti ozbiljne nedostatke na toj lokaciji jer su korektivne i preventivne mjere (CAPA) provedene tek nakon inspekcije.
English: • The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Alkem Laboratories;
Croatian: • je Odbor pregledao sve dostupne podatke i informacije koje su dostavili nositelji odobrenja za stavljanje lijeka u promet/podnositelji zahtjeva, kao i informacije koje je dostavila tvrtka Alkem
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Alkem Laboratories Limited during the period between March 2013 and March 2015;
Croatian: • je Odbor razmotrio postupak proveden sukladno članku 31. Direktive 2001/83/EZ za odobrenja za stavljanje lijeka u promet i zahtjeve za odobrenje za stavljanje lijeka u promet za lijekove za koje su klinički i/ili bioanalitički dijelovi ispitivanja provedeni u tvrtki Alkem Laboratories Limited u razdoblju između ožujka 2013. i ožujka 2015.;