FrancophonIA/ELRC3.0 huggingface dataset:
English: TachoSil is used when standard techniques are not sufficient.
Croatian: TachoSil se koristi kada standardne tehnike nisu dostatne.
English: This summary was last updated in 03-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran u 03. 2016.
English: TachoSil fibrinogen / thrombin
Croatian: TachoSil fibrinogen / trombin
English: The full EPAR for TachoSil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek TachoSil nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: TachoSil is used in adults:
Croatian: TachoSil se koristi u odraslih:
English: What measures are being taken to ensure the safe and effective use of TachoSil?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka TachoSil?
English: The main measure of effectiveness was the number of patients whose bleeding had stopped after three minutes.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika čije je krvarenje zaustavljeno nakon tri minute.
English: TachoSil has been studied in seven studies:
Croatian: TachoSil je ispitan u sedam ispitivanja:
English: Like other sealants, TachoSil may cause an allergic reaction.
Croatian: Poput drugih lijepila, TachoSil može uzrokovati alergijsku reakciju.
English: TachoSil should only be applied directly onto the treatment site so that it covers 1 to 2 cm beyond the edge of the wound.
Croatian: TachoSil se smije primjenjivati samo u mjestu terapije tako da pokriva 1 do 2 cm izvan ruba rane.
English: The amount of TachoSil to be used depends on the size of the wound and the material can be cut to size if needed.
Croatian: Koliko će se matrice TachoSil koristiti ovisi o veličini rane, a materijal se može odrezati na odgovarajuću veličinu prema potrebi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for TachoSil on 8 June 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek TachoSil na snazi u Europskoj uniji od 8. lipnja 2004.
English: TachoSil should only be used by an experienced surgeon.
Croatian: TachoSil treba primjenjivati samo iskusan kirurg.
English: The TachoSil patch is left in the body, where it dissolves and disappears completely.
Croatian: Matrica TachoSil ostavlja se u tijelu, gdje se rastvara i potpuno nestaje.
English: Other information about TachoSil
Croatian: Ostale informacije o lijeku TachoSil
English: The main measure of effectiveness was the time until the bleeding stopped.
Croatian: Glavna mjera djelotvornosti bilo je vrijeme do završetka krvarenja.
English: • during an operation, to stop bleeding and to seal the surfaces of internal organs;
Croatian: • tijekom operacije, kako bi zaustavilo krvarenje i zatvorile površine unutarnjih organa.
English: This is a summary of the European public assessment report (EPAR) for TachoSil.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku TachoSil.
English: Effectiveness was measured by looking at whether air leaked from the lungs after surgery.
Croatian: Djelotvornost je izmjerena tako što je promatrano je li zrak iscurio iz pluća nakon operacije.
English: • during neurological surgery to prevent leakage of the fluid surrounding the brain (called cerebrospinal fluid or CSF).
Croatian: • tijekom neuroloških operacija za sprječavanje istjecanja tekućine koja okružuje mozak (koja se zove cerebrospinalna tekućina ili CSF).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for TachoSil.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka TachoSil.
English: For more information about treatment with TachoSil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom TachoSil pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: This way it prevents the cerebrospinal fluid from leaking.
Croatian: Na taj način sprječava istjecanje cerebrospinalne tekućine.
English: A risk management plan has been developed to ensure that TachoSil is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka TachoSil.
English: TachoSil must not be applied inside a blood vessel.
Croatian: TachoSil se ne smije primjenjivati unutar krvnih žila.
English: The clot enables the patch to stick more firmly to the tissue, helping to stop the bleeding and sealing the wound.
Croatian: Ugrušci omogućuju da se matrica čvršće primi za tkivo te tako pomažu pri zaustavljanju krvarenja i zatvaranju rane.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for TachoSil, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za TachoSil nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What is the risk associated with TachoSil?
Croatian: Koji su rizici povezani s lijekom TachoSil?
English: Thrombin works by converting fibrinogen into smaller units called fibrin, which then stick together to form a local clot.
Croatian: Trombin djeluje tako što reže fibrinogen u manje jedinice naziva fibrin, koji se zatim lijepe zajedno i tvore ugruške.
English: However, in the second study, which involved 301 patients, it took an average of 15.3 hours for leakage to stop with TachoSil compared with 20.5 hours with current techniques.
Croatian: No, u drugom ispitivanju, koje je obuhvatilo 301 bolesnika, bilo je potrebno prosječno 15,3 sata kako bi se istjecanje zaustavilo matricom TachoSil u usporedbi s 20,5 sati koliko je potrebno korištenjem postojeće tehnike.
English: The first study looking at lung surgery patients was not sufficient to support the use of TachoSil in sealing tissue since very few patients in the study had any air leakage.
Croatian: Prvo ispitivanje koje je istražilo bolesnike na operaciji pluća nije bilo dostatno kako bi se potvrdila primjena matrice TachoSil u lijepljenju tkiva budući da je kod vrlo malo bolesnika u ispitivanju došlo do istjecanja zraka.
English: In the study in neurological surgery, TachoSil was comparable to current techniques: around 7% (25 out of 361) of patients treated with TachoSil had a leak of CSF, compared with around 8% (30 out of 365) of patients on current techniques.
Croatian: U ispitivanju kod neuroloških operacija TachoSil je bio usporediv s postojećim tehnikama: kod oko 7% (25 od 361) bolesnika liječenih TachoSilom došlo je do istjecanja CSF-a u usporedbi s oko 8% (30 od 365) bolesnika liječenih postojećim tehnikama.
English: In the first study, the average time until bleeding stopped was 3.9 minutes with TachoSil compared with 6.3 minutes with the argon beamer, and in the second study, these values were 3.6 and 5.0 minutes, respectively.
Croatian: U prvom ispitivanju, prosječno vrijeme potrebno za zaustavljanje krvarenja iznosilo je 3,9 minuta s matricom TachoSil u usporedbi s 6,3 minute s uređajem sa zrakom argona, dok su u drugom ispitivanju ove vrijednosti iznosile 3,6 odnosno 5,0 minuta.
English: • Another study in 726 patients compared TachoSil with current techniques used in daily practice in preventing CSF leakage during neurological surgery.
Croatian: • Drugo ispitivanje na 726 bolesnika usporedilo je TachoSil s postojećim tehnikama koje se svakodnevno koriste za sprječavanje istjecanja CSF-a tijekom neuroloških operacija.
English: Why has TachoSil been approved?
Croatian: Zašto je TachoSil odobren?
English: • Two studies were carried out to see if TachoSil could be used as a tissue sealant.
Croatian: • Dva su ispitivanja provedena kako bi se utvrdilo može li se matrica TachoSil koristiti kao tkivno lijepilo.
English: When TachoSil is applied to a bleeding area during surgery, the moisture causes the active substances to react together, leading to the rapid formation of a clot.
Croatian: Kada se matrica TachoSil primjenjuje na područje krvarenja tijekom operacije, vlaga uzrokuje međureakciju djelatnih tvari, što uzrokuje brzo tvorenje ugrušaka.
English: The active substances in TachoSil, fibrinogen and thrombin, are proteins extracted from blood, which are involved in the natural clotting process.
Croatian: Djelatne tvari u lijeku TachoSil , fibrinogen i trombin, su bjelančevine dobivene iz krvi, uključene u prirodan postupak zgrušavanja.
English: The CHMP decided that TachoSil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka TachoSil nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: • Two of the studies looked at the effects of TachoSil in stopping bleeding.
Croatian: • dva su ispitivanja istražila djelovanje matrice TachoSil za zaustavljanje krvarenja.
English: TachoSil is a sealant patch coated with the active substances human fibrinogen and human thrombin.
Croatian: TachoSil je matrica tkivnog ljepila koja je obložena djelatnom tvari humanim fibrogenom i humanim trombinom.
English: TachoSil was also more effective than standard materials at stopping bleeding during surgery on the heart or blood vessels.
Croatian: TachoSil je bio djelotvorniji od standardnih materijala za zaustavljanje krvarenja tijekom operacija srca ili krvnih žila.
English: • A sixth study looked at the effectiveness of TachoSil in surgery on the heart or major blood vessels.
Croatian: • Šesto je ispitivanje istražilo djelotvornost matrice TachoSil u slučaju operacije srca ili većih krvnih žila.
English: In neurological surgery, it works by sealing together the cut areas of the outermost layer (dura mater) of the membranes around the brain.
Croatian: Kod neuroloških operacija djeluje spajanjem razrezanih dijelova vanjskog sloja (dura mater) membrana koje okružuju mozak.
English: What is TachoSil?
Croatian: Što je TachoSil?
English: The studies compared TachoSil and standard surgical techniques, such as stitching and stapling, in a total of 490 patients having lung surgery.
Croatian: Ispitivanja su usporedila TachoSil i standardne kirurške tehnike poput šivanja i zatvaranja spajalicama u ukupno 490 bolesnika na operaciji pluća.
English: The studies compared the effects of TachoSil and an argon beamer (a device that sears the cut surface and reduces bleeding) in a total of 240 adults having liver surgery.
Croatian: Ispitivanja su usporedila djelovanje matrice TachoSil i uređaja koji koristi zrake argona (uređaja koji isušuje rezane površine te smanjuje krvarenje) kod ukupno 240 odraslih osoba koje su bile na operaciji jetre.
English: The study compared TachoSil with standard materials in 120 patients, of whom around three-quarters also had surgery on vessels with stitches and one-quarter had surgery on the heart.
Croatian: Ispitivanje je usporedilo TachoSil sa standardnim materijalima u 120 bolesnika, od kojih je otprilike tri četvrtine također bilo na operaciji krvnih žila sa šavovima, dok je jedna četvrtina njih bila na operaciji srca.
English: A third study compared TachoSil with standard stitching in 185 patients having kidney surgery.
Croatian: Treće je ispitivanje usporedilo matricu TachoSil sa standardnim šivanjem u 185 bolesnika na operaciji bubrega.
English: • as support to stitching during surgery on the blood vessels;
Croatian: • Djeluje također kao podrška šavovima tijekom operacije krvnih žila;
English: After three minutes, bleeding had stopped in 75% of the patients treated with TachoSil (44 out of 59), compared with 33% of those treated with standard techniques (20 out of 60).
Croatian: TachoSil (44 od 59), u usporedbi s 33% onih koji su liječeni standardnim tehnikama (20 od 60).
English: Patients may also develop antibodies to the proteins in TachoSil, which could interfere with blood clotting.
Croatian: U rijetkim slučajevima, bolesnici mogu također razviti protutijela na bjelančevine u lijeku TachoSil, što može utjecati na stvaranje krvnih ugrušaka.
English: Thromboembolic complications (blood clots in vessels) may occur if TachoSil is applied inside a blood vessel.
Croatian: Tromboembolijske komplikacije (krvni ugrušci u krvnim žilama) mogu se nastupiti ako se TachoSil nenamjerno primjeni unutar krvnih žila.
English: TachoSil was more effective than stitching in the kidney surgery patients.
Croatian: TachoSil je bio djelotvorniji od šivanja kod bolesnika koji su bili na operaciji bubrega.
English: For the full list of all side effects and restrictions with TachoSil, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka TachoSil potražite u uputi o lijeku.
English: What is TachoSil used for?
Croatian: Za što se TachoSil koristi?
English: How does TachoSil work?
Croatian: Kako djeluje TachoSil?
English: TachoSil was more effective than the argon beamer at stopping bleeding during liver surgery.
Croatian: TachoSil je bio djelotvorniji u zaustavljanju krvarenja od uređaja sa zrakom argona tijekom operacije jetre.
English: What benefit has TachoSil shown during the studies?
Croatian: Koje su koristi lijeka TachoSil utvrđene u ispitivanjima?
English: How is TachoSil used?
Croatian: Kako se TachoSil koristi?
English: Doses above 100 mg/kg a day are not recommended because of a potentially increased risk of side effects.
Croatian: Doze iznad 100 mg/kg na dan nisu preporučene zbog potencijalnog povećanog rizika od nuspojava.
English: Further information on Deferiprone Lipomed can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Deferiprone Lipomed nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Over time, the excess iron can damage important organs such as the heart or liver.
Croatian: Višak željeza tijekom vremena može oštetiti važne organe, poput srca ili jetre.
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 ako dovode do iste razine djelatne tvari u tijelu i stoga se očekuje da imaju isti učinak.
English: The usual dose of Deferiprone Lipomed is 75 mg per kilogram body weight each day, divided into three separate doses.
Croatian: Uobičajena doza lijeka Deferiprone Lipomed jest 75 mg po kilogramu težine svakog dana, podijeljena u tri odvojene doze.
English: This helps to correct the iron overload and prevent damage due to excess iron.
Croatian: To pomaže u korigiranju preopterećenja željezom i sprečavanju oštećenja zbog viška željeza.
English: However, the body does not have a natural way of removing excess iron, so it builds up.
Croatian: Međutim, tijelo nema prirodan način za uklanjanje viška željeza pa se ono nagomilava.
English: Patients with thalassaemia major need frequent blood transfusions.
Croatian: Bolesnicima s talasemijom major potrebne su česte transfuzije krvi.
English: This is an inherited disease in which patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body.
Croatian: To je nasljedna bolest pri kojoj bolesnici ne mogu proizvoditi dovoljno hemoglobina, proteina koji se nalazi u crvenim krvnim stanicama koji prenosi kisik kroz tijelo.
English: It attaches to iron in the body to form a compound that can be excreted by the body, mainly in the urine, and to a lesser extent in the stools.
Croatian: Vezuje se za željezo u tijelu i stvara spoj koji se može izlučiti iz tijela, uglavnom kroz urin, a u manjoj mjeri kroz stolicu.
English: The doctor may interrupt treatment if iron levels in the body get too low.
Croatian: Liječnik može prekinuti liječenje ako razina željeza u tijelu postane preniska.
English: • in combination with another iron chelator, when treatment with one iron chelator on its own is ineffective or when prevention or treatment of life-threatening conditions requires rapid or intensive correction of iron levels.
Croatian: • u kombinaciji s drugim kelatorom željeza kada je liječenje samo jednim kelatorom željeza neučinkovito ili kada je za prevenciju ili liječenje stanja opasnih po život potrebna brza ili intenzivna korekcija razine željeza.
English: The doctor may adjust the dose of Deferiprone Lipomed depending on the patient's response, which should be measured every two to three months with blood tests.
Croatian: Liječnik može prilagoditi dozu lijeka Deferiprone Lipomed ovisno o tome kako bolesnik reagira na lijek, što treba svaka dva do tri mjeseca provjeravati krvnim pretragama.
English: Deferiprone Lipomed (deferiprone)
Croatian: Deferiprone Lipomed (deferipron)
English: Deferiprone Lipomed is available as 500 mg tablets to be taken by mouth.
Croatian: Deferiprone Lipomed dostupan je u obliku tableta od 500 mg koje se uzimaju na usta.
English: When patients receive repeated transfusions, the transfused red cells bring iron into the body.
Croatian: Kada bolesnici dobivaju ponovljene transfuzije, crvenim krvnim stanicama unosi se željezo u tijelo.
English: This means that Deferiprone Lipomed contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Ferriprox.
Croatian: To znači da Deferiprone Lipomed sadrži istu djelatnu tvar i djeluje na jednak način kao i „referentni lijek” koji je već odobren u EU-u pod nazivom Ferriprox.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Ferriprox, and do not need to be repeated for Deferiprone Lipomed.
Croatian: Ispitivanja koristi i rizika djelatne tvari u odobrenim primjenama već su provedena s referentnim lijekom Ferriprox, i stoga ih nije potrebno ponavljati za Deferiprone Lipomed.
English: • on its own, when standard iron chelator treatment cannot be used or is inadequate;
Croatian: • kao monoterapija, kada standardno liječenje kelatorom željeza nije primjenjivo ili nije odgovarajuće;
English: Deferiprone Lipomed is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Croatian: Deferiprone Lipomed je „kelator željeza” (tvar koja se veže na željezo), a koristi se za liječenje preopterećenja željezom (višak željeza u tijelu) u bolesnika s talasemijom major.
English: Side effects reported with Deferiprone Lipomed are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Deferiprone Lipomed 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 Deferiprone Lipomed?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Deferiprone Lipomed?
English: Because Deferiprone Lipomed 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 Deferiprone Lipomed generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Deferiprone Lipomed has been shown to have comparable quality and to be bioequivalent to Ferriprox.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, lijek Deferiprone Lipomed dokazao usporedivu kakvoću te da je bioekvivalentan s lijekom Ferriprox.
English: What is Deferiprone Lipomed and what is it used for?
Croatian: Što je Deferiprone Lipomed i za što se primjenjuje?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Deferiprone Lipomed 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 Deferiprone Lipomed nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: An overview of Deferiprone Lipomed and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Deferiprone Lipomed i zašto je odobren u EU-u
English: Deferiprone Lipomed can only be obtained with a prescription and treatment should be started and maintained by a doctor who has experience in the treatment of patients with thalassaemia.
Croatian: Lijek Deferiprone Lipomed izdaje se samo na liječnički recept, a liječenje treba započeti i nadzirati samo liječnik s iskustvom u liječenju bolesnika s talasemijom.
English: What are the benefits and risks of Deferiprone Lipomed?
Croatian: Koje su koristi i rizici lijeka Deferiprone Lipomed?
English: Other information about Deferiprone Lipomed
Croatian: Ostale informacije o lijeku Deferiprone Lipomed
English: For more information about using Deferiprone Lipomed, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Deferiprone Lipomed pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Croatian: Tvrtka je također provela ispitivanje koje je pokazalo da je lijek Deferiprone Lipomed „bioekvivalentan” referentnom lijeku.
English: The active substance in Deferiprone Lipomed, deferiprone, is an iron chelator.
Croatian: Djelatna tvar u lijeku Deferiprone Lipomed, deferipron, jest „kelator željeza”.
English: As for every medicine, the company provided studies on the quality of Deferiprone Lipomed.
Croatian: Kao i za svaki lijek, tvrtka je dostavila podatke o ispitivanjima kakvoće za lijek Deferiprone Lipomed.
English: As for all medicines, data on the use of Deferiprone Lipomed are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Deferiprone Lipomed kontinuirano se prate.
English: The company that markets Deferiprone Lipomed will ensure that patients taking the medicine, or their carers, are provided with a reminder card with information on how to take the medicine safely.
Croatian: Bolesnicima koji uzimaju lijek Deferiprone Lipomed ili njihovim njegovateljima mora se izdati kartica s podsjetnikom o tome kako sigurno uzimati lijek.
English: Why is Deferiprone Lipomed authorised in the EU?
Croatian: Zašto je lijek Deferiprone Lipomed odobren u EU-u?
English: Therefore, the Agency's view was that, as for Ferriprox, the benefit of Deferiprone Lipomed outweighs the identified risk and it can be authorised for use in the EU.
Croatian: Stoga je stav Agencije da korist od lijeka Deferiprone Lipomed, kao i od lijeka Ferriprox, nadmašuje identificirani rizik te da lijek može biti odobren za primjenu u EU-u.
English: Deferiprone Lipomed is used:
Croatian: Deferiprone Lipomed se koristi:
English: Deferiprone Lipomed contains the active substance deferiprone and is a ‘generic medicine'.
Croatian: Deferiprone Lipomed sadrži djelatnu tvar deferipron te je „generički lijek”.
English: How has Deferiprone Lipomed been studied?
Croatian: Kako je Deferiprone Lipomed ispitivan?
English: How does Deferiprone Lipomed work?
Croatian: Kako djeluje Deferiprone Lipomed?