FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of Pemetrexed Lilly is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Croatian: Pemetrexed Lilly u kombinaciji s cisplatinom Preporučena doza lijeka Pemetrexed Lilly je 500 mg/m2 tjelesne površine, a primjenjuje se u obliku intravenske infuzije tijekom 10 minuta, prvog dana svakog 21-dnevnog ciklusa.
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95 % CI = 0.56-0.88, p = 0.002).
Croatian: Uključujući fazu uvodnog liječenja, medijan ukupnog preživljenja u bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice bio je 18,6 mjeseci u skupini koja je primala pemetreksed te 13,6 mjeseci u skupini koja je primala placebo, omjer hazarda = 0,71 (95% CI = 0,56 - 0,88, p = 0,002).
English: Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion
Croatian: Pemetrexed Lilly 100 mg prašak za koncentrat za otopinu za infuziju Pemetrexed Lilly 500 mg prašak za koncentrat za otopinu za infuziju
English: Each vial contains approximately 54 mg sodium.
Croatian: Ovaj lijek sadrži približno 54 mg natrija po bočici.
English: Pemetrexed Lilly 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Croatian: Pemetrexed Lilly 500 mg: Jedna bočica sadrži 500 milligrama pemetrekseda (u obliku pemetrekseddinatrija).
English: Each vial contains approximately 11 mg sodium.
Croatian: Pomoćna tvar s poznatim učinkom Jedna bočica sadrži približno 11 mg natrija.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Croatian: Medijan ukupnog preživljenja u bolesnika s NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice (N = 481) bio je 15,5 mjeseci u skupini koja je primala pemetreksed i 10,3 mjeseca u skupini koja je primala placebo, omjer hazarda = 0,70 (95% CI = 0,56 - 0,88, p = 0,002).
English: At the time of this final survival analysis, 28.7 % of patients were alive or lost to follow up on the pemetrexed arm versus 21.7 % on the placebo arm.
Croatian: 28,7% bolesnika u skupini liječenoj pemetreksedom bilo je živo ili izgubljeno iz praćenja, u odnosu na
English: Excipients
Croatian: Pemetreksed
English: Pemetrexed/cisplatin
Croatian: Pemetreksed/ cisplatin
English: Pemetrexed/ cisplatin
Croatian: Pemetreksed/cisplatin
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated
Croatian: Rezultati tih analiza djelotvornosti su sažeti u tablici koja slijedi: Djelotvornost pemetrekseda + cisplatina u odnosu na monoterapiju cisplatinom u bolesnika s malignim pleuralnim mezoteliomom Randomizirani i liječeni
English: A multicentre, randomised, open label phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288).
Croatian: U multicentričnom, randomiziranom, otvorenom ispitivanju faze III pemetrekseda u odnosu na docetaksel u bolesnika s lokalno uznapredovalim ili metastatskim NSCLC-om nakon prethodne kemoterapije medijan preživljenja bolesnika liječenih pemetreksedom iznosio je 8,3 mjeseca (populacija svih uključenih bolesnika, engl.
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Croatian: Među klinički značajne oblike toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i ≤ 5% bolesnika randomiziranih u skupinu koja je primala cisplatin i pemetreksed, ubrajaju se: zatajenje bubrega, infekcija, vrućica, neutropenijska vrućica, povišene vrijednosti AST-a, ALT-a i GGT-a, urtikarija i bol u prsima.
English: Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic epidermal necrolysis).
Croatian: Obratite se liječniku ako dobijete težak osip, svrbež ili mjehuriće na koži
English: Pemetrexed Lilly in combination with cisplatin
Croatian: Pemetrexed Lilly u monoterapiji
English: EU/1/15/1034/001 EU/1/15/1034/002
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1034/001
English: 100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity In the event of neurotoxicity, the recommended dose adjustment for Pemetrexed Lilly and cisplatin is documented in Table 3.
Croatian: 100% prethodne doze a Zajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998) b Osim neurotoksičnosti
English: 95 % CI = 0.64-0.96).
Croatian: (prilagođeni omjer hazarda 0,94; 95% CI = 0,84 - 1,05).
English: Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion
Croatian: Pemetrexed Lilly 500 mg prašak za koncentrat za otopinu za infuziju
English: Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion
Croatian: Pemetrexed Lilly 100 mg prašak za koncentrat za otopinu za infuziju
English: Pemetrexed at a dose of 500 mg/m2 was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
Croatian: U 64 bolesnika s malignim pleuralnim mezoteliomom koji prethodno nisu primali kemoterapiju, pemetreksed je ispitan u dozi od 500 mg/m2 u monoterapiji.
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio = 0.78,
Croatian: Medijan OS-a od početka prve linije uvodnog liječenja pemetreksedom i cisplatinom iznosio je 16,9 mjeseci u skupini koja je primala pemetreksed te 14,0 mjeseci u skupini koja je primala placebo (omjer hazarda= 0,78, 95% CI = 0,64 - 0,96).
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pemetrexed Lilly 500 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion pemetrexed
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Pemetrexed Lilly 100 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Pemetrexed Lilly treatment.
Croatian: 4 mg dvaput na dan) koje ćete morati uzeti dan prije, na sam dan i dan nakon primjene lijeka
English: Stomatitis/
Croatian: Docetaksel
English: Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetrexed Lilly 500 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetrexed Lilly 100 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Reported symptoms of overdose include neutropenia, anaemia, thrombocytopenia, mucositis, sensory polyneuropathy and rash.
Croatian: neutropenijska vrućica, alergijska reakcija/preosjetljivost, povišene vrijednosti kreatinina, motorička neuropatija, senzorna neuropatija, multiformni eritem i bol u abdomenu.
English: Package leaflet: Information for the user Pemetrexed Lilly 100 mg powder for concentrate for solution for infusion Pemetrexed Lilly 500 mg powder for concentrate for solution for infusion pemetrexed
Croatian: Pemetrexed Lilly 100 mg prašak za koncentrat za otopinu za infuziju Pemetrexed Lilly 500 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Manufacturer Lilly France S.A.S.
Croatian: Eli Lilly Norge A.S.
English: The dose is one inhalation (‘puff') into the mouth once a day at the same time each day.
Croatian: Doza se sastoji od jedne inhalacije (udah) u usta jednom dnevno u isto vrijeme svakog dana.
English: The doctor will decide which inhaler the patient should use.
Croatian: Liječnik će odlučiti kojom se dozom bolesnik treba koristiti.
English: Further information on Relvar Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Relvar Ellipta možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This overview was last updated in 02-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran: 02-2018.
English: It works on various types of immune cells, blocking the release of substances involved in inflammation.
Croatian: Djeluje na različite vrste stanica imunosnog sustava blokirajući otpuštanje tvari koje sudjeluju u upali.
English: In asthma, it is used for regular treatment of patients from 12 years of age:
Croatian: Kad je u pitanju astma, primjenjuje se za redovito liječenje bolesnika u dobi od 12 i više godina:
English: Relvar Ellipta is available as an inhaler in two strengths (92/22 micrograms and 184/22 micrograms).
Croatian: Relvar Ellipta dostupan je kao inhalator u dvije različite jačine (92/22 mikrograma i 184/22 mikrograma).
English: Relvar Ellipta (fluticasone furoate / vilanterol)
Croatian: Relvar Ellipta (flutikazonfuroat/vilanterol)
English: Relvar Ellipta received a marketing authorisation valid throughout the EU on 13 November 2013.
Croatian: Lijek Relvar Ellipta dobio je odobrenje za stavljanje lijeka u promet koje vrijedi na prostoru EU-a od 13. studenoga 2013.
English: In COPD, it is used in adults who have flare-ups of the disease despite regular bronchodilator treatment (treatment to widen the airways).
Croatian: Kad je u pitanju KOPB, primjenjuje se u odraslih koji imaju pogoršanja bolesti usprkos redovitom liječenju bronhodilatatorima (lijekovi koji šire dišne puteve).
English: These patients were already well controlled with the comparator medicine and Relvar Ellipta treatment was able to maintain their FEV1.
Croatian: Ti su bolesnici već bili dobro kontrolirani usporednim lijekom, a primjenom lijeka Relvar Ellipta bilo je moguće održavati njihov FEV1.
English: For more information about using Relvar Ellipta, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Relvar Ellipta pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Relvar Ellipta have also 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 Relvar Ellipta nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Side effects reported with Relvar Ellipta are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Relvar Ellipta pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What measures are being taken to ensure the safe and effective use of Relvar Ellipta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Relvar Ellipta?
English: More serious side effects include pneumonia and fractures (seen in up to 1 in 10 people), which were reported more often in patients with COPD than those with asthma.
Croatian: U ozbiljnije nuspojave ubrajaju se upala pluća i frakture (mogu se javiti u do 1 na 10 osoba), a prijavljivane su češće u bolesnika s KOPB-om nego u bolesnika s astmom.
English: It attaches to beta-2 receptors in the airways and causes the muscles of the airways to relax and widen, allowing the patient to breathe more easily.
Croatian: Veže se na beta-2 receptore i uzrokuje opuštanje i širenje mišića u dišnim putevima zbog čega bolesnik može lakše disati.
English: The European Medicines Agency concluded that Relvar Ellipta's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Relvar Ellipta nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: What is Relvar Ellipta and what is it used for?
Croatian: Što je Relvar Ellipta i za što se koristi?
English: Other information about Relvar Ellipta
Croatian: Ostale informacije o lijeku Relvar Ellipta
English: Relvar Ellipta can only be obtained with a prescription.
Croatian: Relvar Ellipta izdaje se samo na recept.
English: Relvar Ellipta is an inhaler for treating asthma and chronic obstructive pulmonary disease (COPD).
Croatian: Relvar Ellipta je inhalator za liječenje astme i kronične opstruktivne plućne bolesti (KOPB).
English: As for all medicines, data on the use of Relvar Ellipta are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Relvar Ellipta kontinuirano se prate.
English: The most common side effects with Relvar Ellipta (which may affect more than 1 in 10 people) are headache and nasopharyngitis (inflammation of the nose and throat).
Croatian: Najčešće su nuspojave lijeka Relvar Ellipta (koje se mogu javiti u više od 1 na 10 osoba) glavobolja i nazofaringitis (upala nosa i grla).
English: A fourth study in 1,522 patients showed that Relvar Ellipta was as effective as another medicine containing a corticosteroid (fluticasone propionate) and a long-acting beta-2 agonist (salmeterol).
Croatian: Četvrtim ispitivanjem provedenim na 1 522 bolesnika dokazano je da je lijek Relvar Ellipta jednako djelotvoran kao drugi lijek koji sadrži kortikosteroid (flutikazonpropionat) i dugodjelujući beta-2 agonist (salmeterol).
English: This reduces inflammation in the airways and improves the patient's breathing.
Croatian: Time se smanjuje upala dišnih puteva i poboljšava bolesnikovo disanje.
English: An overview of Relvar Ellipta and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Relvar Ellipta i zašto je odobren u EU-u
English: Relvar Ellipta contains two active substances that work in different ways to improve breathing in patients with asthma and COPD.
Croatian: Relvar Ellipta sadrži dvije djelatne tvari koje djeluju na različite načine kako bi poboljšale disanje bolesnika s astmom i KOPB-om.
English: Why is Relvar Ellipta authorised in the EU?
Croatian: Zašto je lijek Relvar Ellipta odobren u EU-u?
English: In two further studies, Relvar Ellipta reduced the number of flare-ups by between 13 and 34% more than vilanterol alone.
Croatian: U dvama daljnjim istraživanjima primjenom lijeka Relvar Ellipta broj pogoršanja smanjen je za između 13 % i 34 % više nego primjenom samo vilanterola.
English: Relvar Ellipta 184/22 also improved FEV1 by 193 ml more than fluticasone furoate and 210 ml more than another inhaler containing fluticasone propionate.
Croatian: Primjenom lijeka Relvar Ellipta 184/22 FEV1 također je poboljšan, i to za 193 ml više nego primjenom flutikazonfuroata i za 210 ml više nego primjenom drugog inhalatora koji sadrži flutikazonpropionat.
English: What are the risks associated with Relvar Ellipta?
Croatian: Koji su rizici povezani s lijekom Relvar Ellipta?
English: In a third study, fewer patients taking Relvar Ellipta 92/22 had at least one severe flare-up after a year of treatment than those taking fluticasone furoate alone (13% versus 16%).
Croatian: U trećem ispitivanju broj bolesnika liječenih lijekom Relvar Ellipta 92/22 koji su imali najmanje jedno pogoršanje nakon godinu dana liječenja bio je manji od broja takvih bolesnika liječenih samo flutikazonfuroatom (13 % u odnosu na 16 %).
English: The first study showed that Relvar Ellipta 92/22 improved average FEV1 by 115 ml more than placebo, and a second study showed that Relvar Ellipta 184/22 improved average FEV1 by 131 ml more than placebo.
Croatian: U prvom ispitivanju dokazano je da se primjenom lijeka Relvar Ellipta 92/22 prosječni FEV1 poboljšao za 115 ml više nego primjenom placeba, a u drugom ispitivanju dokazano je da se primjenom lijeka Relvar Ellipta 184/22 prosječni FEV1 poboljšao 131 ml više nego primjenom placebo.
English: Relvar Ellipta contains the active substances fluticasone furoate and vilanterol.
Croatian: Relvar Ellipta sadrži djelatne tvari flutikazonfuroat i vilanterol.
English: In two of the studies, Relvar Ellipta 92/22 increased the volume of air a patient could breathe out in one second (FEV1) by 36 ml more than fluticasone furoate alone and 172 ml more than placebo (a dummy treatment).
Croatian: U dva od tri ispitivanja primjenom lijeka Relvar Ellipta 92/22 volumen zraka koji je bolesnik mogao izdahnuti u jednoj sekundi (FEV1) povećan je za 36 ml više nego primjenom samo flutikazonfuroata i za 172 ml više nego uz primjenu placeba (prividno liječenje).
English: How is Relvar Ellipta used?
Croatian: Kako se Relvar Ellipta koristi?
English: Four studies in over 5,500 patients showed that Relvar Ellipta improves breathing and reduces flareups of symptoms in patients with COPD.
Croatian: U četiri ispitivanja provedena na više od 5 500 bolesnika dokazano je da lijek Relvar Ellipta poboljšava disanje i umanjuje pogoršanje simptoma u bolesnika s KOPB-om.
English: Three studies in over 3,200 patients showed that Relvar Ellipta improves breathing and reduces flareups in patients with asthma.
Croatian: U trima ispitivanjima provedenima na više od 3 200 bolesnika dokazano je da Relvar Ellipta poboljšava disanje i umanjuje pogoršanja u bolesnika s astmom.
English: Regarding its safety, the most frequent side effects reported with Relvar Ellipta were similar to those seen with other COPD and asthma treatments; an increased incidence of pneumonia was observed in patients with COPD.
Croatian: Kad je riječ o sigurnosti, najčešće nuspojave prijavljene za lijek Relvar Ellipta bile su slične nuspojavama zapaženima u slučaju liječenja drugim lijekovima protiv KOPB-a i astme.
English: Relvar Ellipta improves breathing and reduces flare ups of symptoms in patients with asthma and COPD.
Croatian: Primjenom lijeka Relvar Ellipta poboljšava se disanje i umanjuje pogoršanje simptoma u bolesnika s astmom i KOPB-om.
English: What benefits of Relvar Ellipta have been shown in studies?
Croatian: Koje su koristi lijeka Relvar Ellipta dokazane u ispitivanjima?
English: • whose symptoms are not controlled with an inhaled corticosteroid and an inhaled short-acting
Croatian: • u kojih simptome nije moguće kontrolirati inhalacijskim kortikosteroidima i inhalacijskim kratkodjelujućim beta-2 agonistom,
English: How does Relvar Ellipta work?
Croatian: Kako djeluje Relvar Ellipta?
English: • whose symptoms are adequately controlled with both inhaled corticosteroids and a long-acting
Croatian: • u kojih simptome nije moguće dovoljno kontrolirati kombinacijom inhalacijskih kortikosteroida i inhalacijskog dugodjelujućeg beta-2 agonista.
English: For the full list of side effects of Relvar Ellipta, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Relvar Ellipta potražite u uputi o lijeku.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 October 2015 EMA/679015/2015 EMEA/H/C/003914
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23. listopada 2015. EMA/749928/2015 EMEA/H/C/003914
English: The Committee was concerned that the main study had not been carried out in accordance with the guidelines for Good Clinical Practice (GCP).
Croatian: Odbor je bio zabrinut da glavno ispitivanje nije izvršeno u skladu s smjernicama za Dobru kliničku praksu (GCP).
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju i potrebne su vam dodatne informacije o liječenju, kontaktirajte liječnika koji vam propisuje liječenje.
English: The main measure of effectiveness was the ability to stop bleeding during a 10-minute observation period, after applying the method to stop the bleeding.
Croatian: Glavna mjera djelotvornosti bila je sposobnost zaustavljanja krvarenja tijekom 10-minutnog opservacijskom razdoblja, nakon primjene metode zaustavljanja krvarenja.
English: The applicant presented data from one main study involving 167 patients who underwent vascular surgery.
Croatian: Podnositelj zahtjeva dostavio je podatke iz jednog glavnog ispitivanja koje je obuhvatilo 167 bolesnika koji su se podvrgavali vaskularnom kirurškom zahvatu.
English: When applied to a moist surface, the thrombin is activated and cuts fibrinogen up into smaller units called fibrin.
Croatian: Ako se primjenjuje na vlažnu površinu, trombin se aktivira i reže fibrinogen u manje jedinice naziva fibrin.
English: It was to be available as two separate solutions that are mixed together to prepare a sealant that is applied to the surface of blood vessels.
Croatian: Trebao je biti dostupan kao dvije zasebne otopine koje se zajedno miješaju da bi se pripremilo brtvilo koje se primjenjuje na površini krvnih žila.
English: How is VeraSeal expected to work?
Croatian: Kako VeraSeal treba djelovati?
English: VeraSeal is a medicine that contains the active substances human fibrinogen and human thrombin.
Croatian: VeraSeal je lijek koji sadrži aktivne tvari humanog fibrogena i humanog trombina.
English: The active substances in VeraSeal, human fibrinogen and human thrombin, are natural proteins in the blood and are obtained from blood donors.
Croatian: Djelatna tvar lijeka VeraSeal, humani fibrinogen i humani trombin, su prirodni proteini u krvi i dobivaju se iz krvi donatora.
English: On 29 September 2015, Instituto Grifols S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for marketing authorisation of VeraSeal, which was intended to help stop bleeding during vascular (blood vessel) surgery when standard surgical methods for controlling bleeding are insufficient.
Croatian: Dana 29. rujna 2015., Instituto Grifols S.A. službeno je obavijestio Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoju prijavu za odobrenje za stavljanje u promet lijeka VeraSeal, koji je namijenjen kao pomoć pri zaustavljanju krvarenja tijekom vaskularnih kirurških zahvata (na krvnim žilama) kada standardne kirurške metode za kontroliranje krvarenja nisu dostatne.
English: There are no consequences for patients in the three ongoing clinical trials.
Croatian: Nema posljedica za pacijente koji su u ovom trenutku uključeni u klinička ispitivanja.
English: In its letter notifying the Agency of the withdrawal of the applications, the company stated that the withdrawal was due to not being able to gather the additional data required by the CHMP, including data from three ongoing clinical studies with the product, within the available timeframe.
Croatian: U svojem dopisu kojim obaviještava Agenciju o povlačenju prijave, tvrtka je navela da povlačenje nije uslijed nemogućnosti prikupljanja dodatnih potrebnih podataka zatraženih od strane CHMP-a, uključujući podatke iz tri klinička ispitivanja koja su u tijeku s proizvodima, unutar dostupnog vremenskog okvira.
English: This helps prevent bleeding and seals the blood vessels.
Croatian: Ovo pomaže pri sprječavanju krvarenja i brtvi krvne žile.
English: The company informed the CHMP that there are currently no ongoing compassionate use programmes for VeraSeal.
Croatian: Tvrtka je obavijestila CHMP da trenutno ne postoje programi milosrdnog davanja lijekova za lijek VeraSeal.
English: What is VeraSeal?
Croatian: Što je VeraSeal?