FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substances in Evarrest, fibrinogen and thrombin, are proteins extracted from the blood, which are involved in the natural clotting process.
Croatian: Djelatne tvari u lijeku Evarrest, fibrinogen i trombin, su proteini dobiveni iz krvi, koji su uključeni u prirodan postupak zgrušavanja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Evarrest was shown to be effective when used to stop bleeding in surgery and the product could be a suitable alternative to other products and techniques.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da se Evarrest pokazao djelotvornim kada se koristio za prekid krvarenja pri kirurškom zahvatu, te da bi proizvod mogao biti pogodna zamjena za druge proizvode i tehnike.
English: The clots enable the patch to stick more firmly to the tissue thereby helping to stop the bleeding.
Croatian: Ugrušci omogućuju da se pokrov čvršće primi za tkivo te tako pomažu pri zaustavljanju krvarenja.
English: One study compared Evarrest with another product, Surgicel, in patients undergoing abdominal, thoracic and pelvic surgeries.
Croatian: Jedno je ispitivanje usporedilo Evarrest s drugim proizvodom, Surgicel, u bolesnika koji se podvrgavaju abdominalnim, torakalnim i pelvičnim kirurškim zahvatima.
English: For practical information about using Evarrest, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Evarrest, bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: Two studies compared Evarrest with commonly used surgical techniques considered to be standard care.
Croatian: Dva su ispitivanja usporedila Evarrest s kirurškim tehnikama koje se često koriste, a smatraju se standardnom skrbi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evarrest, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Evarrest uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What benefits of Evarrest have been shown in studies?
Croatian: Koje koristi lijeka Evarrest su dokazane u ispitivanjima?
English: During surgery, the patches are cut to shape and size and used to seal off the bleeding area.
Croatian: Tijekom kirurškog zahvata, pokrovi se režu u odgovarajuće oblike i veličine, te se koriste za zatvaranje područja krvarenja.
English: When an Evarrest patch is applied to a bleeding area during surgery, the moisture causes the active substances to react together, leading to the rapid formation of clots.
Croatian: Kada se pokrov Evarrest primjenjuje na područje krvarenja tijekom kirurškog zahvata, vlaga uzrokuje međureakciju djelatnih tvari, što uzrokuje brzo tvorenje ugrušaka.
English: Evarrest is a surgical product used in adults to help stop bleeding during surgery when standard methods for controlling bleeding are not sufficient.
Croatian: Evarrest je kirurški proizvod koji se koristi u odraslih kao pomoć za zaustavljanje krvarenja tijekom kirurškog zahvata u slučajevima kada standardne metode za kontrolu krvarenja nisu dostatne.
English: Evarrest has been shown in studies to be effective in helping to stop bleeding during surgeries, with most patients having their bleeding stopped within 4 minutes.
Croatian: U ispitivanjima je dokazano da je Evarrest djelotvorna pomoć u zaustavljanju krvarenja tijekom kirurških zahvata, pri čemu je u većine bolesnika zaustavljeno krvarenje u roku od 4 minute.
English: 98% of the patients in the Evarrest group (59 out of 60) had their bleeding stopped within 4 minutes (with no recurrence of bleeding during a 6-minute observation period) compared with 53% of patients in the Surgicel group (16 out of 30).
Croatian: U 98% bolesnika u Evarrest grupi (59 od 60) krvarenje je zaustavljeno u roku od 4 minute (bez ponovnog pojavljivanja krvarenja tijekom razdoblja promatranja od 6 minuta) u usporedbi s 53% u bolesnika u Surgicel grupi (16 od 30).
English: For more information about treatment with Evarrest, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju Everrast pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku
English: The complications that arise in patients being treated with Evarrest are generally related to the surgical procedure and the underlying conditions, and include post-surgery bleeding and increased fibrinogen levels in the blood.
Croatian: Komplikacije koje nastaju u bolesnika koji se liječe lijekom Evarrest načelno su povezane s kirurškim zahvatima i stanjima koja su u podlozi i uključuju krvarenje nakon kirurškog zahvata i povišene razine fibrinogena u krvi.
English: How is Evarrest used?
Croatian: Kako se Evarrest koristi?
English: The complications seen in studies with Evarrest were generally related the surgical procedure and the underlying conditions although there were cases of re-bleeding from the sites where Evarrest patches were used.
Croatian: Komplikacije uočene u ispitivanjima provedenima s lijekom Evarrest povezane su općenito s kirurškim postupcima i stanjima koja su u podlozi, iako nije bilo slučaja ponovnog krvarenja u lokacijama gdje su se koristili pokrovi Evarrest.
English: Similar results were seen in a study in patients undergoing liver surgery: 83% of patients in the Evarrest group (33 out of 40) had their bleeding stopped within 4 minutes compared with 30% of the standard care group (13 out of 44).
Croatian: Slični su rezultati uočeni u ispitivanju u bolesnika koji se podvrgavaju kirurškom zahvatu na jetri: u 83% bolesnika u Evarrest grupi (33 od 40) zaustavljeno je krvarenja u roku od 4 minute u usporedbi s 30% u grupi koja je primala standardnu skrb (13 od 44).
English: In a study in patients undergoing abdominal, thoracic and pelvic surgeries, 84% of patients in the Evarrest group had their bleeding stopped within 4 minutes (50 out of 59) compared with 31% (10 out of 32) in the standard care group.
Croatian: U ispitivanju u bolesnika koji se podvrgavaju abdominalnim, torakalnim i pelvičnim kirurškim zahvatima, u 84% bolesnika u Evarrest grupi (50 od 59) krvarenje je zaustavljeno u roku od 4 minute u usporedbi s 31% (10 od 32) u bolesnika u standardnoj grupi.
English: For the full list of all side effects reported with Evarrest, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Evarrest potražite u uputi o lijeku.
English: How does Evarrest work?
Croatian: Kako Evarrest djeluje?
English: Concentrate for solution for infusion
Croatian: Veličina pakovanja otopina za injekciju koncentrat za otopinu za infuziju
English: The full EPAR and risk management plan summary for Pemetrexed medac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Pemetrexed medac nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Croatian: Može se također koristiti kao terapija održavanja u bolesnika koji su primili kemoterapiju na bazi platine.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: Objašnjava kako je Agencija ocijenila ovaj lijek da bi preporučila njegovo odobrenje u EU-u te uvjete za njegovu primjenu.
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Croatian: Lijek se izdaje samo na liječnički recept i smije se primjenjivati samo pod nadzorom liječnika koji ima iskustva u primjeni kemoterapije.
English: This means that Pemetrexed medac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Croatian: To znači da je Pemetrexed medac sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Alimta.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Croatian: Pretvorba pemetrekseda u njegov djelatni oblik nastupa prije u stanicama raka nego u normalnim stanicama, što rezultira većim razinama djelatnog oblika lijeka i duljim djelovanjem u stanicama raka.
English: Because Pemetrexed medac is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Pemetrexed medac generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Croatian: Kao rezultat toga smanjuje se dijeljenje stanica raka, pri čemu je utjecaj na normalne stanice tek neznatan.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Croatian: U tijelu pemetreksed se pretvara u djelatni oblik koji blokira djelovanje enzima koji su uključeni u proizvodnju „nukleotida” (temeljni elementi koji formiraju DNK i RNK, genetski materijal stanica).
English: It is not intended to provide practical advice on how to use Pemetrexed medac.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Pemetrexed medac.
English: Pemetrexed medac is a cancer medicine used to treat two types of lung cancer:
Croatian: Pemetrexed medac lijek je protiv raka koji se koristi za liječenje dvaju tipova raka pluća:
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed medac.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Pemetrexed medac.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed medac?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pemetrexed medac?
English: A risk management plan has been developed to ensure that Pemetrexed medac is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Pemetrexed medac.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed medac, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Pemetrexed medac uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Pemetrexed medac is a ‘generic medicine'.
Croatian: Pemetrexed medac je „generički lijek”.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed medac has been shown to be comparable to Alimta.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je kako je u skladu sa zahtjevima EU-a dokazano da je lijek Pemetrexed medac usporediv s lijekom Alimta.
English: What is Pemetrexed medac and what is it used for?
Croatian: Što je Pemetrexed medac i za što se koristi?
English: Pemetrexed medac is available as a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Pemetrexed medac dostupan je kao prašak koji se koristi za pripremu otopine za infuziju (drip) u venu.
English: No additional studies were needed as Pemetrexed medac is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Croatian: Nisu bila potrebna dodatna ispitivanja jer je Pemetrexed medac generički lijek koji se daje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek Alimta.
English: When Pemetrexed medac is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Croatian: Ako se Pemetrexed medac primjenjuje s cisplatinom, prije ili nakon doze cisplatina bolesniku također treba dati „antiemetik” (za sprječavanje povraćanja) i tekućinu (za sprječavanje dehidracije).
English: What are the benefits and risks of Pemetrexed medac?
Croatian: Koje su koristi i rizici lijeka Pemetrexed medac?
English: For more information about treatment with Pemetrexed medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Pemetrexed medac pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: Other information about Pemetrexed medac
Croatian: Ostale informacije o lijeku Pemetrexed medac
English: The Committee recommended that Pemetrexed medac be approved for use in the EU.
Croatian: Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje u promet lijeka Pemetrexed medac u EU-u.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Croatian: Za dodatne informacije vidjeti sažetak opisa svojstava lijeka (također dio EPAR-a).
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed medac.
Croatian: Kako bi se ublažile nuspojave, bolesnici tijekom terapije lijekom Permetrexed medac trebaju uzimati kortikosteroid (tip lijeka koji smanjuje upalu) i folnu kiselinu (tip vitamina) te primati injekcije vitamina B12.
English: Why is Pemetrexed medac approved?
Croatian: Zašto je Pemetrexed medac odobren?
English: Pemetrexed medac pemetrexed
Croatian: Pemetrexed medac pemetreksed
English: For practical information about using Pemetrexed medac, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Pemetrexed medac pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: The active substance in Pemetrexed medac, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Croatian: Djelatna tvar lijeka Pemetrexed medac, pemetreksed, citotoksičan je lijek (lijek koji uzrokuje smrt stanica koje se dijele, kao što su stanice karcinoma), a ubraja se u grupu „antimetabolita”.
English: Pemetrexed medac contains the active substance pemetrexed.
Croatian: Pemetrexed medac sadrži djelatnu tvar pemetreksed.
English: How does Pemetrexed medac work?
Croatian: Kako djeluje Pemetrexed medac?
English: How is Pemetrexed medac used?
Croatian: Kako se Pemetrexed medac koristi?
English: How has Pemetrexed medac been studied?
Croatian: Kako je Pemetrexed medac ispitivan?
English: Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
Croatian: Stoga je stav Povjerenstva kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Alimta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pemetrexed medac on 27 November 2015.
Croatian: Europska agencija za lijekove, 2015.
English: • The maximum dose should not exceed 2 g per day.
Croatian: • Maksimalna doza ne smije premašivati 2 g dnevno.
English: • Patients who have any questions about their treatment should talk to their doctor or pharmacist.
Croatian: • Bolesnici koji imaju bilo kakva pitanja o svojoj terapiji trebaju se obratiti svojem liječniku ili ljekarniku.
English: For younger children, the use of age-appropriate formulations is recommended.
Croatian: U mlađe djece preporučuje se primjena formulacija prikladnih za njihovu dob.
English: Changes aim to ensure appropriate use in context of fight against antimicrobial resistance
Croatian: Izmjenama se nastoji zajamčiti odgovarajuća primjena u kontekstu borbe protiv antimikrobne otpornosti
English: The review of vancomycin-containing medicines was initiated on 1 April 2016 at the request of the Spanish medicines agency (AEMPS), under Article 31 of Directive 2001/83/EC.
Croatian: Ocjenjivanje lijekova koji sadržavaju vankomicin započeto je 1. travnja 2016. na zahtjev Španjolske agencije za lijekove i medicinske proizvode (AEMPS) u skladu s člankom 31. Direktive 2001/83/EZ.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 21/09/2017.
Croatian: Mišljenje CHMP-a proslijeđeno je Europskoj komisiji koja je 21. rujna 2017. donijela konačnu, pravno obvezujuću odluku koja se primjenjuje u svim državama članicama EU-a.
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 adopted the Agency's opinion.
Croatian: Ocjenjivanje je provelo Povjerenstvo za lijekove za primjenu kod ljudi (CHMP), odgovorno za pitanja koja se odnose na lijekove za primjenu kod ljudi, koje je usvojilo mišljenje Agencije.
English: Vancomycin-containing medicines have been authorised nationally in the EU for many years, as Vancocin and a variety of other names.
Croatian: Lijekovi koji sadržavaju vankomicin odobreni su niz godina u EU-u na nacionalnoj razini kao Vancocin i pod raznim drugim imenima.
English: On 19 May 2017, the European Medicines Agency (EMA) recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria.
Croatian: Europska agencija za lijekove (EMA) preporučila je 19. svibnja 2017. izmjene informacija za propisivanje antibiotika vankomicina kako bi se zajamčila odgovarajuća primjena u liječenju ozbiljnih infekcija uzrokovanih gram-pozitivnim bakterijama.
English: Vancomycin is one of a group of antibiotics known as glycopeptides.
Croatian: Vankomicin pripada skupini antibiotika poznatih pod nazivom glikopeptidi.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 September 2017 EMA/645879/2017
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21. rujna 2017.
English: • The available information on vancomycin has been reviewed and recommendations have been made on its safe use and appropriate dosage.
Croatian: • Pregledane su dostupne informacije o vankomicinu te su donesene preporuke u pogledu njegove sigurne primjene i odgovarajućeg doziranja.
English: Information for healthcare professionals The Agency's recommendations are based on a review of the available pharmacological and clinical data for vancomycin.
Croatian: Preporuke Agencije temelje se na pregledu dostupnih farmakoloških i kliničkih podataka za vankomicin.
English: Vancomycin capsules
Croatian: Vankomicin u obliku kapsula
English: EMA recommends changes to prescribing information for vancomycin antibiotics
Croatian: EMA preporučuje izmjene informacija za propisivanje antibiotika vankomicina
English: Therefore, oral vancomycin should no longer be used in these indications.
Croatian: Stoga se vankomicin u tim indikacijama više ne smije primjenjivati peroralno.
English: In addition, the Committee reviewed the recommended dosage for vancomycin for the various indications and patient groups, and concluded that the starting dose of vancomycin by infusion should be calculated according to the age and weight of the patient.
Croatian: Osim toga, Odbor je pregledao preporuke za doziranje vankomicina za različite indikacije i skupine bolesnika i zaključilo je da bi početnu dozu za primjenu vankomicina infuzijom trebalo izračunavati prema dobi i tjelesnoj težini bolesnika.
English: • The product information for medicines containing vancomycin will be updated to take these recommendations into account.
Croatian: • Informacije o lijeku za lijekove koji sadržavaju vankomicin bit će ažurirane kako bi se uzele u obzir ove preporuke.
English: It is given as an infusion (drip) into a vein or by injection in the abdomen (belly).
Croatian: Primjenjuje se intravenskom infuzijom (drip) ili injektiranjem u abdomen (trbuh).
English: The updated recommendations are based on data which showed that the previously recommended dose often resulted in less than optimal levels of vancomycin in the blood, reducing the effectiveness of the antibiotic.
Croatian: Ažurirane preporuke temelje se na podatcima koji su pokazali da su prethodno preporučene doze često rezultirale razinama vankomicina u krvi koje nisu bile optimalne, što je smanjivalo djelotvornost tog antibiotika.
English: • Vancomycin is an antibiotic used for serious infections, often caused by bacteria that have become resistant to other treatments.
Croatian: • Vankomicin je antibiotik koji se primjenjuje za liječenje ozbiljnih infekcija, često izazvanih bakterijama koje su postale otporne na druge oblike liječenja.
English: When taken by mouth, use should be limited to the treatment of Clostridium difficile infections (CDI).
Croatian: Kada se uzima kroz usta, primjenu treba ograničiti na liječenje infekcija bakterijom Clostridium difficile (CDI).
English: Because the available data do not adequately support the use of vancomycin in the treatment of staphylococcal enterocolitis (inflammation of the gut caused by S. aureus) and its use to clear the gut of bacteria in patients with a weakened immune (defence) system, the CHMP concluded that vancomycin should no longer be used for these indications.
Croatian: Budući da dostupni podatci ne podupiru na odgovarajući način primjenu vankomicina u liječenju stafilokoknog enterokolitisa (upala crijeva uzrokovana bakterijom S. aureus) i primjenu vankomicina u uklanjanju bakterija iz crijeva bolesnika s oslabljenim imunosnim (obrambenim) sustavom, CHMP je zaključio da se vankomicin više ne smije primjenjivati za te indikacije.
English: • Vancomycin solution for infusion can be used in patients of all ages for the treatment of complicated soft-tissue infections, bone and joint infections, community- and hospital-acquired pneumonia (including ventilator-associated pneumonia), infective endocarditis, acute bacterial meningitis, and bacteraemia associated with the above infections.
Croatian: • Vankomicin u obliku otopine za infuziju može se primjenjivati u bolesnika svih dobi za liječenje kompliciranih infekcija mekog tkiva, infekcija kostiju i zglobova, izvanbolnički i bolnički stečene pneumonije (uključujući pneumoniju povezanu s ventilatorom), infektivnog endokarditisa, akutnog bakterijskog meningitisa i bakterijemije koja je povezana s navedenim infekcijama.
English: • The recommended starting dose of vancomycin solution for infusion should be based on the age and weight of the patient.
Croatian: • Preporučena početna doza otopine vankomicina za infuziju treba se temeljiti na dobi i tjelesnoj težini bolesnika.
English: Available data showed that the previously recommended daily dose often resulted in suboptimal vancomycin serum concentrations.
Croatian: Dostupni podatci pokazuju da su prethodno preporučene dnevne doze često rezultirale koncentracijama vankomicina u serumu koje nisu bile optimalne.
English: It can also be taken by mouth (as capsules or liquid) to treat an infection of the lining of the gut caused by bacteria called Clostridium difficile.
Croatian: Također se može uzimati kroz usta (u obliku kapsula ili tekućine) za liječenje upale stjenke crijeva koju izaziva bakterija Clostridium difficile.