FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency concluded that the benefits of Diotop outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Croatian: Agencija je zaključila da koristi od lijeka Diotop nadmašuju s njim povezane rizike te da se odobrenje za stavljanje u promet izdano u Ujedinjenoj Kraljevini može priznati u drugim državama članicama EU-a u kojima je tvrtka podnijela zahtjev za stavljanje u promet.
English: The Agency considered that, although the particular combination in Diotop (diclofenac 75 mg / omeprazole 20 mg) has never been tested in any published study, the data from studies of higher doses of diclofenac or other NSAIDs taken with omeprazole are enough to support the use of the specific combination in Diotop.
Croatian: Agencija je smatrala da su, iako ova specifična kombinacija u lijeku Diotop (75 mg diklofenaka i 20 mg omeprazola) nije ispitivana ni u jednom objavljenom ispitivanju, podatci iz ispitivanja provedenih s višim dozama diklofenaka ili drugih NSAID-ova u kombinaciji s omeprazolom dovoljni za odobrenje primjene ove specifične kombinacije Diotopa.
English: The Agency therefore concluded that the benefits of Diotop outweigh its risks, and therefore the marketing authorisation for Diotop should be granted in Germany.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Diotop nadmašuju s njim povezane rizike te da se shodno tome odobrenje za stavljanje u promet treba izdati u Njemačkoj.
English: Diclofenac is a nonsteroidal antiinflammatory drug (NSAID) used for the relief of pain and inflammation in a wide range of conditions.
Croatian: Diklofenak je nesteroidni protuupalni lijek (NSAID) koji se primjenjuje za ublažavanje boli i upale kod različitih poremećaja.
English: Omeprazole is a widely-used treatment for indigestion and acid reflux that acts by reducing the amount of acid the stomach makes.
Croatian: Omeprazol se redovito primjenjuje za poremećaje probave i refluks kiseline tako što smanjuje količinu kiseline koju proizvodi želudac.
English: EMA recommends authorisation of Diotop (diclofenac / omeprazole capsules) in the EU
Croatian: EMA preporučuje izdavanje odobrenja za lijek Diotop (kapsule diklofenaka/omeprazola)
English: Diotop is a medicine used to relieve symptoms such as swelling and pain caused by the joint disorders rheumatoid arthritis, osteoarthritis or ankylosing spondylitis.
Croatian: Diotop je lijek koji se primjenjuje za ublažavanje simptoma oticanja i boli u zglobovima koje uzrokuju reumatoidni artritis, osteoartritis ili ankilozantni spondilitis.
English: Diotop is used in adult patients who are at risk of developing stomach ulcers and whose disease is already controlled by diclofenac and omeprazole, the two active substances in Diotop, taken separately.
Croatian: Diotop se primjenjuje u odraslih bolesnika kod kojih postoji rizik od razvoja čireva na želudcu te čija se bolest već kontrolira diklofenakom i omeprazolom, odnosno s dvije djelatne tvari lijeka Diotop, koje se primjenjuju kao monoterapija.
English: Information for patients and for healthcare professionals
Croatian: Informacije za bolesnike i zdravstvene djelatnike
English: The specific recommendations of the CHMP are as follows:
Croatian: Konkretne preporuke CHMP-a jesu sljedeće:
English: More about the medicines
Croatian: Više o lijekovima
English: EMA recommends suspension of one medicine
Croatian: EMA preporučuje ukidanje jednog lijeka
English: Its suspension is therefore not expected to have any impact on patients in the EU.
Croatian: Stoga se očekuje da njegovo ukidanje neće imati nikakvog učinka na bolesnike u EU-u.
English: So far no alternative studies from other sources have been provided.
Croatian: Zasad ne postoje alternativna ispitivanja iz drugih izvora.
English: • Patients should continue to take their medicines as prescribed.
Croatian: • Bolesnici trebaju nastaviti s uzimanjem propisanih lijekova.
English: The review of Alkem was initiated on 1 April 2016 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.
Croatian: Postupak ocjene lijeka Alkem započet je 1. travnja 2016. na zahtjev njemačke agencije za lijekove (BfArM), u skladu s člankom 31. Direktive 2001/83/EZ.
English: The findings cast doubts on the quality management system in place at the site, and thus on the reliability of the data of bioequivalence studies conducted between March 2013 and March 2015.
Croatian: Rezultati bacaju sumnju na sustav upravljanja kvalitetom koji se primjenjuje na lokaciji, a time i na pouzdanost podataka iz ispitivanja bioekvivalencije provedenih u razdoblju između ožujka 2013. i ožujka 2015.
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Croatian: Pregled je proveo Odbor za lijekove za humanu uporabu (CHMP), koji je odgovoran za pitanja koja se odnose na lijekove za humanu uporabu te koji je usvojio mišljenje Agencije.
English: EMA will continue to work closely with national authorities and international partners to ensure that studies underpinning marketing authorisations in the EU are carried out to the highest standards and that companies continue to comply fully with all aspects of Good Clinical Practice (GCP).
Croatian: EMA će i dalje blisko surađivati s nacionalnim tijelima i međunarodnim partnerima kako bi osigurali da su ispitivanja na kojima se temelje odobrenja za stavljanje lijeka u promet unutar EU-a provedena u skladu s najvišim standardima te da poduzeća uključena u ova ispitivanja u cijelosti udovoljavaju svim aspektima dobre kliničke prakse (GCP-a).
English: The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from studies conducted by Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad410208 India.
Croatian: Ocjenom su obuhvaćeni lijekovi odobreni u okviru nacionalnih postupaka u pojedinačnim državama članicama EU-a čiji su zahtjevi za odobrenje za stavljanje lijeka u promet sadržavali podatke iz ispitivanja koja je provelo poduzeće Alkem Laboratories Ltd, Odjel za bioekvivalenciju, C-17/7, Industrijsko naselje MIDC, Taloja, okrug Raigad - 410208 Indija.
English: The recommendations followed a joint routine inspection by German and Dutch authorities in March 2015, which revealed misrepresentation of data during the conduct of two different trials performed in 2013 and 2014 at the Taloja site.
Croatian: Preporuke su izdane nakon zajedničke rutinske inspekcije koju su u ožujku 2015. provela njemačka i nizozemska nadležna tijela, a kojima je otkriveno pogrešno prikazivanje podataka tijekom dvaju različitih ispitivanja provedenih 2013. i 2014. na lokaciji u Taloji.
English: The CHMP's recommendations concerning these medicines were sent to the European Commission, which issued a legally binding decision valid throughout the EU.
Croatian: Preporuke CHMP-a o ovim lijekovima poslane su Europskoj komisiji, koja je objavila pravno obvezujuću odluku koja vrijedi na cijelom području EU-a.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 8 September 2016.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji, koja je 8. rujna 2016. donijela konačnu pravno obvezujuću odluku primjenjivu u svim državama članicama EU-a.
English: Other riluzole-containing medicines remain available.
Croatian: Ostali lijekovi koji sadrže riluzol ostaju dostupni.
English: Medicines under evaluation cannot be granted authorisation on the basis of these studies; further data would have to be provided to support authorisation.
Croatian: Na temelju tih ispitivanja ne može se izdati odobrenje za lijekove u postupku procjene; za izdavanje odobrenja potrebno je dostaviti daljnje podatke.
English: Therefore, the Committee recommended that medicines authorised or being evaluated on the basis of these studies should be suspended or refused authorisation, unless alternative data are available from other sources.
Croatian: Stoga je Odbor izdao preporuku prema kojoj treba obustaviti ili odbiti odobrenje za odobrene lijekove ili lijekove koji su u postupku procjene na temelju tih ispitivanja, osim ako su dostupni podaci iz drugih izvora.
English: • There is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by Alkem Laboratories Ltd.
Croatian: • Nema dokaza o štetnosti ili nedostatku djelotvornosti bilo kojeg lijeka povezanog s ispitivanjima koja je provelo poduzeće Alkem Laboratories Ltd.
English: EMA's Committee for Medicinal Products for Human Use (CHMP) noted that, although there is no evidence of harm or lack of effectiveness linked to the conduct of studies by Alkem Laboratories Ltd, the studies cannot be accepted in marketing authorisation applications in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji primijetio je da, iako ne postoje dokazi o štetnosti ili nedovoljnoj djelotvornosti povezani s provedbom ispitivanja poduzeća Alkem Laboratories Ltd, ispitivanja se ne mogu prihvatiti u okviru zahtjeva za odobrenje za stavljanje lijeka u promet u EU-u.
English: It also included ongoing marketing authorisation applications for medicines which use study data from the site.
Croatian: Ocjenom su također obuhvaćeni aktualni zahtjevi za odobrenje za stavljanje lijeka u promet u kojima su se koristili podaci iz ispitivanja provedenih na navedenoj lokaciji.
English: • Ibuprofen Orion, a painkiller currently under evaluation by national authorities, cannot be authorised on the basis of studies carried out at Alkem Laboratories Ltd.
Croatian: • Za Ibuprofen Orion, analgetik za koji nadležna nacionalna tijela trenutačno provode procjenu, ne može se izdati odobrenje na temelju ispitivanja provedenih na lokacijama poduzeća Alkem Laboratories Ltd.
English: • The medicine being suspended, Riluzole Alkem, contains riluzole and is not yet on the market in the EU.
Croatian: • Predmetni lijek, Riluzole Alkem, sadrži riluzol i još nije stavljen na tržište EU-a.
English: • Riluzole Alkem, a medicine for amyotrophic lateral sclerosis (ALS) which has yet to be marketed in the EU, should now be suspended.
Croatian: • treba ukinuti odobrenje za Riluzole Alkem, lijek za amiotrofičnu lateralnu sklerozu (ALS), koji još nije stavljen u promet na tržištu EU-a.
English: • Some studies carried out at the Alkem Laboratories Ltd site have been found to be flawed.
Croatian: • Utvrđeno je da neka ispitivanja provedena na lokaciji poduzeća Alkem Laboratories Ltd imaju nedostatke, zbog čega se ukida jedan lijek.
English: • Cefuroxime Ingen Pharma, currently under evaluation by national authorities, can still be considered for authorisation, as studies from other sources have been provided.
Croatian: • Budući da su dostavljeni rezultati ispitivanja iz drugih izvora, i dalje se može razmatrati izdavanje odobrenja za Cefuroxime Ingen Pharma, lijek za koji nacionalna nadležna tijela trenutačno provode procjenu.
English: On 23 June 2016, the European Medicines Agency (EMA) recommended the suspension of a medicine (Riluzole Alkem), for which studies were conducted at the Alkem Laboratories Ltd site in Taloja, India, and has required companies to provide new data for another medicine before it can be authorised in the EU.
Croatian: Europska agencija za lijekove (EMA) preporučila je ukidanje lijeka (Riluzole Alkem) za koji su ispitivanja provedena na lokaciji poduzeća Alkem Laboratories Ltd u Taloji u
English: • Cefuroxime Alkem and Cefuroxime Krka (antibiotics) can remain on the market in the EU, as alternative studies have been provided that support a positive benefit-risk balance.
Croatian: • Budući da su dostavljeni rezultati alternativnih ispitivanja koji dokazuju pozitivan omjer koristi i rizika, lijekovi Cefuroxime Alkem i Cefuroxime Krka (antibiotici) mogu ostati na tržištu EU-a.
English: 8 September 2016 EMA/633777/2016 Rev. 1
Croatian: 8. rujna 2016.
English: The European Commission issued a decision on 28 September 2017.
Croatian: Europska komisija donijela je odluku 28. rujna 2017.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 September 2017
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28. rujna 2017.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/124)
Croatian: Ishod postupka upućivanja u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/124)
English: Which data has the CVMP reviewed?
Croatian: Koje je podatke pregledao CVMP?
English: Consequently, on 1 September 2016, France initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Croatian: Slijedom toga, Francuska je 1. rujna 2016. pokrenula postupak u skladu s člankom 35. Direktive 2001/82/EZ za navedene veterinarsko-medicinske proizvode.
English: The veterinary medicinal products Zanil and associated names, and generic products thereof, are oral suspensions containing 34 mg oxyclozanide per ml.
Croatian: Veterinarsko-medicinski proizvod Zanil i pridružena imena te njegovi generički lijekovi oralne su suspenzije koje sadržavaju 34 mg oksiklozanida po ml.
English: France noted that across the European Union for Zanil and associated names, and generic products thereof, there are different approved withdrawal periods for cattle, sheep and goats, e.g. cattle meat and offal from 10 days to 28 days; cattle milk from zero hours to 108 hours; sheep meat and offal from 14 days to 28 days; sheep milk from ‘do not use in sheep producing milk for human consumption' to 7 days; goat meat and offal 14 days; goat milk zero days.
Croatian: Francuska je primijetila da za VMP Zanil i pridružena imena te njegove generičke lijekove u Europskoj uniji postoje različita odobrena razdoblja karencije za goveda, ovce i koze, npr. za meso i iznutrice goveda od 10 do 28 dana; za mlijeko goveda od nula do 108 sati; za meso i iznutrice ovaca od 14 do 28 dana; za mlijeko ovaca od „nije za primjenu u ovaca od kojih se dobiva mlijeko za prehranu ljudi” do sedam dana; za meso i iznutrice koza 14 dana; za mlijeko koza nula dana.
English: Oxyclozanide is a salicylanilide anthelmintic, used for the treatment of fasciolosis in cattle, sheep and goats and also for elimination of gravid tapeworm segments (Moniezia spp).
Croatian: Oksiklozanid je antihelmintik salicilanilid koji se primjenjuje za liječenje fascioloze u goveda, ovaca i koza, kao i za uklanjanje gravidnih članaka trakavica (Moniezia spp).
English: Questions and answers on Zanil and associated names, and generic products thereof EMA/586006/2017
Croatian: Pitanja i odgovori o VMP-u Zanil i pridruženim imenima te njegovim generičkim lijekovima EMA/707684/2017
English: The CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products are required in order to amend the product information accordingly.
Croatian: CVMP je preporučio izmjene uvjeta odobrenja za stavljanje u promet za navedene veterinarsko-medicinske proizvode kako bi se na odgovarajući način izmijenile informacije o VMP-u.
English: The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for milk, meat and offal derived from treated cattle, sheep and goats.
Croatian: Od CVMP-a je zatraženo da pregleda sve dostupne podatke o izlučivanju rezidua i preporuči razdoblja karencije za mlijeko, meso i iznutrice dobivene od liječenih goveda, ovaca i koza.
English: Questions and answers on Zanil and associated names, and generic products thereof
Croatian: Pitanja i odgovori o VMP-u Zanil i pridruženim imenima te njegovim generičkim lijekovima
English: On 13 July 2017, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat, milk and offal) for cattle, sheep and goats for Zanil and associated names, and generic products thereof.
Croatian: Europska agencija za lijekove (Agencija) dovršila je 13. srpnja 2017. ocjenjivanje sigurnosti potrošača u pogledu razdoblja karencije za goveda, ovce i koze (meso, mlijeko i iznutrice) za VMP Zanil i pridružena imena te njegove generičke lijekove.
English: Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.
Croatian: Nositelji odobrenja za stavljanje u promet dostavili su podatke proizvođača i znanstvene referentne izvore o izlučivanju rezidua.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to withdrawal periods for cattle, sheep and goats to provide assurance for consumer safety.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da je ukupni omjer koristi i rizika za te proizvode pozitivan te je preporučio izmjenu razdoblja karencije za goveda, ovce i koze kako bi se zajamčila sigurnost potrošača.
English: Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for Zanil and associated names, and generic products thereof, is positive and agreed that the withdrawal periods (meat, milk and offal) for cattle, sheep and goats should be amended to provide assurance for consumer safety.
Croatian: CVMP je na temelju evaluacije trenutačno dostupnih podataka zaključio da je ukupni omjer koristi i rizika VMP-a Zanil i pridruženih imena te njegovih generičkih lijekova pozitivan te se složio da je potrebno izmijeniti razdoblja karencije za goveda, ovce i koze (meso, mlijeko i iznutrice) kako bi se zajamčila sigurnost potrošača.
English: Why were Zanil and associated names, and generic products thereof reviewed?
Croatian: Zašto su ponovno ocijenjeni VMP Zanil i pridružena imena te njegovi generički lijekovi?
English: What are Zanil and associated names, and generic products thereof?
Croatian: Što su VMP Zanil i pridružena imena te njegovi generički lijekovi?
English: Blister (OPA/Alu/PVC) 60 tablets
Croatian: Blister (OPA/Alu/PVC)
English: Tablet container (HDPE) 60 tablets
Croatian: Spremnik (HDPE)
English: Package size
Croatian: Veličina pakiranja
English: EU number
Croatian: Broj (EU) odobrenja Zaštićeno ime
English: Important to open
Croatian: Važno je otvoriti
English: NC= Failure
Croatian: NC= neuspjeh
English: They will tell you how to use the syringe correctly.
Croatian: Oni će Vam reći kako pravilno koristiti štrcaljku.
English: Given twice daily with food
Croatian: Dvaput na dan s hranom
English: This is especially important for infants and young children.
Croatian: To je posebno važno kod dojenčadi i male djece.
English: Instead, contact your doctor.
Croatian: Umjesto toga se javite svom liječniku.
English: Your doctor can explain these symptoms to you.
Croatian: Liječnik Vam može objasniti ove simptome.
English: This leaflet was last revised in: {MM/YYYY}
Croatian: Ova uputa je zadnji puta revidirana u: {MM/GGGG}
English: Special Populations
Croatian: Posebne populacije
English: What Kaletra is and what it is used for
Croatian: Što je Kaletra i za što se koristi
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Croatian: U tipičnom su slučaju takve reakcije uočene tijekom prvih nekoliko tjedana ili mjeseci nakon uvođenja CART-a.
English: Adults and adolescents
Croatian: Odrasli i adolescenti
English: On rare occasions these muscle disorders have been serious.
Croatian: U rijetkim slučajevima ovi su mišićni poremećaji bili ozbiljni.
English: You should tell your doctor promptly about these or any other symptoms.
Croatian: Odmah obavijestite liječnika o ovim ili bilo kojim drugim simptomima.
English: QD BID Difference [95% CI]
Croatian: QD BID Razlika [95% CI]
English: • heart medicines including:
Croatian: • lijekovi za srce uključujući:
English: • loss or changed sense of taste;
Croatian: • gubitak ili promjena osjeta okusa;
English: In some patients additional factor VIII was given.
Croatian: Neki bolesnici su dodatno primali faktor VIII.
English: Do not transfer it to any other container.
Croatian: Nemojte ju prebacivati u druge spremnike.
English: However, only the increase in voxilaprevir exposure is considered clinically relevant.
Croatian: Međutim, samo se povećanje izloženosti voksilapreviru smatra klinički značajnim.
English: • damage to nerves of the peripheral nervous system;
Croatian: • oštećenje živaca perifernog živčanog sustava;
English: Take the next dose as usual.
Croatian: Uzmite sljedeću dozu u uobičajeno vrijeme.
English: Amprenavir concentrations are significantly reduced.
Croatian: Koncentracije amprenavira značajno su smanjene.
English: • Do not take Kaletra if you are currently taking avanafil or vardenafil.
Croatian: • Ne uzimajte lijek Kaletra ako trenutno uzimate avanafil ili vardenafil.
English: How do I measure the correct dose?
Croatian: Kako ćete izmjeriti točnu dozu?
English: The amount of alcohol in this medicine may affect your ability to drive or use machines and may affect your judgement and reaction times.
Croatian: Količina alkohola u ovom lijeku može utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima kao i na Vaše rasuđivanje i vrijeme reagiranja.
English: Lopinavir can be used during pregnancy if clinically needed.
Croatian: Lopinavir se može uzimati tijekom trudnoće ukoliko je klinički potrebno.
English: Children less than 2 years of age
Croatian: Djeca mlađa od 2 godine
English: Check with your doctor or pharmacist if you are not sure how you should take your medicine.
Croatian: Provjerite s liječnikom ili ljekarnikom ako niste sigurni kako biste trebali uzimati Vaš lijek.
English: Kaletra does this by slowing down the spread of the infection in your body.
Croatian: Kaletra to čini usporavajući širenje infekcije u Vašem tijelu.
English: • red blood cells in the urine;
Croatian: • crvene krvne stanice u urinu;
English: • If you cannot contact your doctor, go to the hospital.
Croatian: • Ako ne možete obavijestiti svog liječnika, javite se u bolnicu.
English: • a sound in one ear or both ears, such as buzzing, ringing or whistling;
Croatian: • zvuk u jednom ili oba uha, kao što je zujanje, zvonjenje ili zviždanje;
English: − This medicine has been prescribed for you or your child only.
Croatian: Ovaj je lijek propisan samo Vama ili Vašem djetetu.
English: Black ‘O' ring
Croatian: Crni „O“ prsten
English: Each bottle contains 120 tablets.
Croatian: Svaka boca sadrži 120 tableta.
English: The following side effects have been reported by patients who took this medicine.
Croatian: Sljedeće nuspojave zabilježene su kod bolesnika koji su uzimali ovaj lijek.
English: Component of a multipack, can't be sold separately.
Croatian: Dio višestrukog pakiranja, ne može se izdavati zasebno.
English: In this picture we have pulled out the plunger so that you can see each part clearly.
Croatian: Na ovoj je slici klip izvađen iz tijela štrcaljke tako da jasno možete vidjeti oba dijela.
English: • a flare-up of symptoms related to an inactive infection in your body (immune reconstitution);
Croatian: • pojava simptoma povezanih s neaktivnom infekcijom u Vašem tijelu (imunološka rekonstitucija);
English: Kaletra may cause changes in your heart rhythm and the electrical activity of your heart.
Croatian: Kaletra može uzrokovati promjene u Vašem srčanom ritmu i u električnoj aktivnosti srca.
English: These changes may be seen on an ECG (electrocardiogram).
Croatian: Te promjene se mogu vidjeti na EKG-u (elektrokardiogram).
English: DM-6705 (delamanid active metabolite):
Croatian: DM-6705 (aktivni metabolit delamanida):
English: > 25 to 35
Croatian: > 25 do 35
English: Other medicines may also contain alcohol and alcohol may be consumed in food and drinks.
Croatian: Drugi lijekovi također mogu sadržavati alkohol, a alkohol se može unijeti u tijelo i putem hrane i pića.