FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for VeraSeal.
Croatian: Stoga, u trenutku povlačenja, CHMP je bio mišljenja da tvrtka nije dostavila dovoljno podataka da bi podržala prijavu za lijek VeraSeal.
English: The fibrin then aggregates (sticks together) and forms fibrin clots on the surface of blood vessels.
Croatian: Fibrin zatim agregira (lijepi) i oblikuje ugruške fibrina na površini krvnih žila.
English: Findings from a GCP inspection of the study sites raised serious questions about the data from the main study submitted in support of the application.
Croatian: Nalazi inspekcije na mjestima ispitivanja, koja je provedena od strane GCP-a, rezultirali su postavljanjem ozbiljnih pitanja o podacima iz glavnog ispitivanja dostavljenima u prilog zahtjeva.
English: VeraSeal was expected to be used to help stop bleeding during vascular surgery when standard surgical methods for controlling bleeding are insufficient.
Croatian: VeraSeal se trebao koristiti kao pomoć pri zaustavljanju krvarenja tijekom kirurškog zahvata u slučajevima kada standardne kirurške metode za kontroliranje krvarenja nisu dostatne.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Croatian: Zahtjev je povučen nakon što je CHMP ocijenio početnu dokumentaciju koju je tvrtka dostavila te je sastavio popise pitanja.
English: EMA/679015/2015
Croatian: (humani fibrinogen / humani trombin) EMA/749928/2015
English: What was VeraSeal expected to be used for?
Croatian: Za što se VeraSeal trebao koristiti?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal the CHMP had concerns and was of the provisional opinion that VeraSeal could not have been approved to help stop bleeding during vascular surgery.
Croatian: Na temelju pregleda podataka te odgovora proizvođača na popise pitanja CHMP-a, u trenutku povlačenja CHMP nije smatrao da postoje problemi te je njihovo privremeno mišljenje bilo kako je moguće dati odobrenje za VeraSeal kao pomoć za zaustavljanje krvarenja tijekom vaskularnog zahvata.
English: In this study, bleeding during surgery was managed either by applying VeraSeal or by
Croatian: U ovom ispitivanju, krvarenjima tijekom kirurškog zahvata upravljano je primjenom lijeka VeraSeal ili primjenom ručnog pritiska (standardna
English: applying manual pressure (a standard way of stopping bleeding during surgery).
Croatian: metoda zaustavljanja krvarenja tijekom kirurškog zahvata).
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Croatian: Dva su lijeka bioekvivalentna kad proizvode iste razine djelatne tvari u tijelu pa se stoga očekuje da imaju jednak učinak.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down its multiplication in the body.
Croatian: Kada je taj enzim blokiran, virus se ne razmnožava na uobičajen način, što usporava njegovo umnožavanje u tijelu.
English: This allows effective treatment while avoiding a higher dose of darunavir.
Croatian: Time se omogućuje djelotvorno liječenje i ujedno izbjegava veća doza darunavira.
English: may be given to adults or children from 3 years of age and weighing at least 15 kg.
Croatian: Darunavir Krka d.d. može se davati odraslim osobama ili djeci starijoj od 3 godine čija je tjelesna težina najmanje 15 kg.
English: For more information on generic medicines, see the questionand-answer document here.
Croatian: Više informacija o generičkim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje.
English: can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Darunavir Krka d.d. nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ritonavir reduces the breakdown of darunavir, increasing the levels of darunavir in the blood.
Croatian: Ritonavir smanjuje stopu razgradnje darunavira, čime se povećava razina darunavira u krvi.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Krka d.d.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari pri odobrenoj primjeni već su provedena za referentni lijek, Prezista, te ih ne treba ponavljati za lijek Darunavir Krka d.d.
English: does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Darunavir Krka d.d. ne liječi infekciju HIV-om ni AIDS, no liječenjem se može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
English: Therefore, the Agency's view was that, as for Prezista, the benefit outweighs the identified risk.
Croatian: Stoga je stav Agencije da korist nadmašuje identificirani rizik, kao i za lijek Prezista.
English: contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Prezista.
Croatian: To znači da Darunavir Krka d.d. sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Prezista.
English: For more information about treatment with Darunavir Krka d.d., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Darunavir Krka d.d., pročitajte uputu o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: It is given with low-dose ritonavir or, in adults, with cobicistat.
Croatian: Primjenjuje se s niskim dozama ritonavira ili u odraslih s kobicistatom.
English: What are the benefits and risks of Darunavir Krka d.d.
Croatian: Koje su koristi i rizici od lijeka Darunavir Krka d.d.?
English: What measures are being taken to ensure the safe and effective use of Darunavir Krka d.d.
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Darunavir Krka d.d.?
English: is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Lijek Darunavir Krka d.d. protuvirusni je lijek koji se primjenjuje u kombinaciji s drugim lijekovima protiv virusa HIV-a za liječenje osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: For practical information about using Darunavir Krka d.d., patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Darunavir Krka d.d. bolesnici trebaju pročitati uputu o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: The active substance in Darunavir Krka d.d., darunavir, is a protease inhibitor.
Croatian: Djelatna tvar u lijeku Darunavir Krka d.d., darunavir, inhibitor je proteaze.
English: is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Darunavir Krka d.d. generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: It is not intended to provide practical advice on how to use Darunavir Krka d.d.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Darunavir Krka d.d.
English: can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV.
Croatian: Darunavir Krka d.d. izdaje se samo na liječnički recept, a liječenje mora započeti zdravstveni radnik s iskustvom u liječenju infekcije HIV-om.
English: The medicine is to be taken with low-dose ritonavir or, as an alternative in adults, with cobicistat and with other HIV medicines, and should be taken with food.
Croatian: Lijek se uzima s niskim dozama ritonavira ili u odraslih s kobicistatom te drugim lijekovima za liječenje HIV-a, a uzima se uz obrok.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Krka d.d.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Darunavir Krka d.d. nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Darunavir Krka d.d., taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Kad se uzima u kombinaciji s drugim lijekovima protiv HIV-a, Darunavir Krka d.d. smanjuje koncentraciju HIV-a u krvi i održava je na niskoj razini.
English: is always given with ritonavir.
Croatian: Darunavir Krka d.d. uvijek se daje uz ritonavir.
English: Other information about Darunavir Krka d.d.
Croatian: Ostale informacije o lijeku Darunavir Krka d.d.
English: is a ‘generic medicine'.
Croatian: Darunavir Krka d.d. jest „generički lijek”.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka d.d.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, dokazano da lijek Darunavir Krka d.d. posjeduje usporedivu razinu kvalitete i da je bioekvivalentan lijeku Prezista.
English: As for every medicine, the company provided studies on the quality of Darunavir Krka d.d.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Darunavir Krka d.d. Tvrtka je provela i ispitivanje koje je pokazalo da je lijek „bioekvivalentan” referentnom lijeku.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Darunavir Krka d.d.
Croatian: Agencija je preporučila izdavanje odobrenja za primjenu lijeka Darunavir Krka d.d. u EU-u.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Darunavir Krka d.d. Objašnjava kako je Agencija ocijenila lijek kako bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
English: is available as tablets.
Croatian: Darunavir Krka d.d. dostupan je u obliku tableta.
English: Why is Darunavir Krka d.d.
Croatian: Zašto je Darunavir Krka d.d. odobren?
English: contains the active substance darunavir.
Croatian: Darunavir Krka d.d. sadržava djelatnu tvar darunavir.
English: How does Darunavir Krka d.d.
Croatian: Kako se Darunavir Krka d.d. koristi?
English: How has Darunavir Krka d.d.
Croatian: Kako djeluje Darunavir Krka d.d.?
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States
Croatian: POPIS NAZIVA, FARMACEUTSKOG OBLIKA, JAČINE LIJEK A, PUTA PRIMJENE, PODNOSITELJA ZAHTJEVA U DRŽAVAMA ČLANICAMA
English: Annex I
Croatian: DODATAK
English: Spain
Croatian: I
English: United Kingdom
Croatian: Jačina
English: The recommended dose is 150 mg twice a day.
Croatian: Preporučena je doza 150 mg dva puta dnevno.
English: Further information on Verzenios can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Verzenios možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Verzenios is available as tablets (50 mg, 100 mg and 150 mg).
Croatian: Verzenios je dostupan u obliku tableta (50 mg, 100 mg i 150 mg).
English: Verzenios (abemaciclib)
Croatian: Verzenios (abemaciklib)
English: Data were considered sufficient to conclude that Verzenios can be of benefit also in women who have not yet been through the menopause.
Croatian: Podatci su se smatrali dovoljnima za zaključak da Verzenios može biti koristan i u žena koje još nisu prošle menopauzu.
English: The dose should be reduced if the patient is also taking certain medicines called ‘CYP3A4 inhibitors'.
Croatian: Dozu je potrebno smanjiti ako bolesnica uzima i neke lijekove pod nazivom „inhibitori CYP3A4”.
English: What measures are being taken to ensure the safe and effective use of Verzenios?
Croatian: Koje se mjere poduzimaju da bi se osigurala sigurna i učinkovita primjena lijeka Verzenios?
English: Other information about Verzenios
Croatian: Ostale informacije o lijeku Verzenios
English: What is Verzenios and what is it used for?
Croatian: Što je Verzenios i za što se koristi?
English: Verzenios can only be used when the cancer cells have certain types of receptor (called hormone receptors) on their surface (HR-positive) and do not produce abnormally large quantities of another receptor called HER2 (HER2-negative).
Croatian: Verzenios se može primjenjivati samo onda kada stanice raka imaju određene vrste receptora (pod nazivom hormonski receptori) na svojoj površini (HR-pozitivne) i ne proizvode prevelike količine drugog receptora pod nazivom HER2 (HER2-negativne).
English: Regarding safety, the main risk is diarrhoea, which is considered manageable with dose reduction.
Croatian: U pogledu sigurnosti primjene, glavni rizik je proljev, koji se može kontrolirati smanjenjem doze.
English: It is used together with a hormonal medicine, either an aromatase inhibitor or fulvestrant.
Croatian: Upotrebljava se zajedno s hormonskim lijekom, inhibitorom aromataze ili fulvestrantom.
English: For more information about using Verzenios, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Verzenios pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: What are the risks associated with Verzenios?
Croatian: Koji su rizici povezani s lijekom Verzenios?
English: Side effects reported with Verzenios are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Verzenios pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: An overview of Verzenios and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Verzenios i zašto je odobren u EU-u
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Verzenios 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 Verzenios nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Why is Verzenios authorised in the EU?
Croatian: Zašto je lijek Verzenios odobren u EU-u?
English: The most common side effects with Verzenios (which may affect more than 1 in 10 people) are diarrhoea, infections, neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), tiredness, nausea (feeling sick), vomiting and decreased appetite.
Croatian: Najčešće nuspojave lijeka Verzenios (koje se mogu pojaviti u više od 1 na 10 osoba) bile su proljev, infekcije, neutropenija (niske razine neutrofila, vrste bijelih krvnih stanica), anemija (mali broj crvenih krvnih stanica), umor, mučnina (slabost), povraćanje i smanjeni apetit.
English: Verzenios contains the active substance abemaciclib.
Croatian: Verzenios sadrži djelatnu tvar abemaciklib.
English: As for all medicines, data on the use of Verzenios are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Verzenios kontinuirano se prate.
English: The active substance in Verzenios, abemaciclib, blocks the activity of enzymes known as cyclindependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide.
Croatian: Djelatna tvar u lijeku Verzenios, abemaciklib, blokira aktivnost enzima poznatih kao kinaze ovisne o ciklinima (CDK) 4 i 6, koje su važne za regulaciju načina na koji stanice rastu i dijele se.
English: Verzenios can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Croatian: Verzenios se izdaje samo na recept, a liječenje smije započeti i mora ga nadzirati liječnik s iskustvom u primjeni lijekova za liječenje raka.
English: Verzenios is a cancer medicine used to treat women with breast cancer that is advanced or has spread to other parts of the body.
Croatian: Verzenios je lijek protiv raka za liječenje žena s rakom dojke koji je napredovao ili se proširio u druge dijelove tijela.
English: The European Medicines Agency decided that the benefits of Verzenios are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Verzenios nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Grapefruit juice should be avoided during treatment with Verzenios as it may affect the way the medicine is absorbed and broken down in the body.
Croatian: Tijekom liječenja lijekom Verzenios potrebno je izbjegavati sok od grejpa jer on može utjecati na način na koji se lijek apsorbira i razgrađuje u tijelu.
English: By blocking CDK4 and CDK6, Verzenios slows the growth of HR-positive breast cancer cells.
Croatian: Blokiranjem CDK4 i CDK6, Verzenios usporava rast HRpozitivnih stanica raka dojke.
English: A third study, conducted in 132 women who had received previous cancer treatment, failed to demonstrate that Verzenios used on its own was of benefit in the treatment of HR-positive, HER2negative breast cancer that had started to spread.
Croatian: U trećem ispitivanju koje je provedeno u 132 žene koje su već prije bile liječene protiv raka, nije se uspjelo dokazati da je Verzenios kada se primjenjivao samostalno bio koristan za liječenje HRpozitivnog, HER2-negativnog raka dojke koji se počeo širiti.
English: Two main studies, involving 1,162 women, mostly postmenopausal, with HR-positive, HER2-negative breast cancer that had started to spread, showed that Verzenios can prolong the time patients live without their disease getting worse (progression-free survival).
Croatian: U dvama glavnim ispitivanjima koja su obuhvatila 1 162 žene, većinom u postmenopauzi, s HRpozitivnim i HER2-negativnim rakom dojke koji se počeo širiti, pokazalo se da Verzenios može bolesnicama produljiti vrijeme življenja bez pogoršanja bolesti (preživljenje bez napredovanja bolesti).
English: In the second study women taking Verzenios and fulvestrant lived on average 16 months without their disease getting worse, compared with 9 months for women taking placebo and fulvestrant.
Croatian: U drugom ispitivanju žene koje su uzimale Verzenios i fulvestrant živjele su u prosjeku 16 mjeseci bez pogoršanja bolesti, u usporedbi s 9 mjeseci za žene koje su uzimale placebo i fulvestrant.
English: Verzenios used with an aromatase inhibitor or fulvestrant increased the time it took for the disease to get worse in postmenopausal women with HR-positive and HER2-negative breast cancer that is advanced or metastatic.
Croatian: Lijek Verzenios primjenjivan s inhibitorom aromataze produljio je vrijeme proteklo do pogoršanja bolesti u žena u postmenopauzi s HR-pozitivnim i HER2-negativnim rakom dojke koji je uznapredovao ili metastazirao.
English: How is Verzenios used?
Croatian: Kako se Verzenios koristi?
English: In the first study women taking Verzenios and an aromatase inhibitor (letrozole or anastrozole) lived on average 28 months without their disease getting worse compared with 15 months for women taking placebo (a dummy treatment) and an aromatase inhibitor.
Croatian: U prvom ispitivanju žene koje su uzimale Verzenios i inhibitor aromataze (letrozol ili anastrozol) živjele su u prosjeku 28 mjeseci bez pogoršanja bolesti u usporedbi s 15 mjeseci u žena koje su uzimale placebo (prividno liječenje) i inhibitor aromataze.
English: How does Verzenios work?
Croatian: Kako djeluje Verzenios?
English: What benefits of Verzenios have been shown in studies?
Croatian: Koje su koristi od lijeka Verzenios dokazane u ispitivanjima?
English: In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably.
Croatian: U nekih tipova raka, uključujući HR-pozitivan rak dojke, povećana je aktivnost CDK-a 4 i 6 što pridonosi
English: For the full list of side effects and restrictions of Verzenios, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja za lijek Verzenios potražite u uputi o lijeku.
English: Very rare, not known
Croatian: Vrlo rijetko, nepoznato*
English: • Adults and older people
Croatian: • Odrasli i starije osobe
English: Crospovidone type A
Croatian: krospovidon, tip A
English: Date of latest renewal: 21 march 2014
Croatian: Datum prvog odobrenja: 28. srpanj 2009 Datum posljednje obnove: 21. ožujak 2014
English: Acino AG Am Windfeld 35 83714 Miesbach Germany
Croatian: Acino AG Am Windfeld 35 83714 Miesbach Njemačka
English: Their frequency is defined using the following conventions: common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Njihova je učestalost definirana na sljedeći način: česte (≥1/100 do <1/10); manje česte (≥1/1000 do <1/100); rijetke (≥1/10 000 do <1/1000); vrlo rijetke (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: You should take Clopidogrel Acino for as long as your doctor continues to prescribe it.
Croatian: Klopidogrel Acino trebate uzimati sve dok Vam ga liječnik propisuje.
English: This leaflet was last revised in <MM/YYYY>.
Croatian: Ova uputa je zadnji puta revidirana u <MM/GGGG>.
English: Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of chance.
Croatian: Kako ispitivanje CAPRIE nije za cilj imalo procijeniti djelotvornost u pojedinačnim podskupinama, nije jasno jesu li razlike relativnog smanjenja rizika unutar podskupina stvarne ili su slučajan rezultat.
English: Titanium dioxide (E171)
Croatian: titanijev dioksid (E171)
English: An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.
Croatian: Povremeno uzimanje acetilsalicilatne kiseline (ne više od 1000 mg tijekom 24 sata) općenito ne izaziva probleme, ali o produljenom uzimanju u drugim okolnostima morate razgovarati s liječnikom.
English: If you suffer from severe liver disease.
Croatian: • ako patite od teške bolesti jetre.
English: Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
Croatian: Prevencija aterotrombotičkih i tromboembolijskih događaja u fibrilaciji atrija
English: Patients should be followed carefully for any signs of bleeding including occult bleeding,especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
Croatian: Bolesnike treba pomno nadzirati radi bilo kakvih znakova krvarenja, uključujući okultno krvarenje, poglavito tijekom prvih tjedana liječenja i/ili nakon invazivnih kardioloških postupaka ili kirurških zahvata.
English: Ethylcellulose (E462)
Croatian: etilceluloza (E462)
English: Since higher doses of ASA were associated with higher bleeding risk it is recommended that the dose of ASA should not be higher than 100 mg.
Croatian: Budući da su više doze acetilsalicilatne kiseline bile povezane s višim rizikom od krvarenja, preporučuje se da doza ASK ne bude veća od 100 mg.