FrancophonIA/ELRC3.0 huggingface dataset:
English: In the second study lasting a year, patients treated with Trydonis had 20% fewer exacerbations (flareups of symptoms) per year than patients treated with tiotropium (a long-acting muscarinic receptor antagonist).
Croatian: U drugom ispitivanju koje je trajalo godinu dana bolesnici liječeni lijekom Trydonis imali su 20 % manje egzacerbacija (razbuktavanja simptoma) godišnje nego bolesnici liječeni tiotropijem (antagonist muskarinskih receptora).
English: In the third study lasting a year, patients treated with Trydonis had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide.
Croatian: U trećem ispitivanju koje je trajalo godinu dana bolesnici liječeni lijekom Trydonis imali su 15 % manje egzacerbacija godišnje nego bolesnici liječeni kombinacijom indakaterola (dugodjelujući beta-2 agonist) i glikopironijeva bromida.
English: How does Trydonis work?
Croatian: Kako djeluje Trydonis?
English: In this study, Trydonis was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.
Croatian: U tom je ispitivanju lijek Trydonis bio jednako učinkovit u pogledu smanjenja broja egzacerbacija kao i tiotropij u kombinaciji s beklometazonom i formoterolom.
English: For the full list of side effects and restrictions with Trydonis, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Trydonis potražite u uputi o lijeku.
English: Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Croatian: Budući da ti receptori pomažu u kontroli stezanja mišića dišnih putova, njihovim blokiranjem mišići se opuštaju, čime se pomaže držati dišne putove otvorenima i bolesniku omogućuje lakše disanje.
English: By attaching to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Croatian: Spajanjem na te receptore uzrokuje opuštanje mišića, što održava dišne putove otvorenima i pomaže bolesniku pri disanju.
English: This leads to a reduction in the release of substances involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Croatian: To dovodi do smanjenog otpuštanja tvari koje sudjeluju u procesu upale, poput histamina, čime se dišni putovi održavaju prohodnima i bolesnik lakše diše.
English: Trydonis is effective at reducing the frequency of exacerbations and improving lung function of patients with COPD.
Croatian: Trydonis učinkovito smanjuje učestalost egzacerbacija i poboljšava rad pluća u bolesnika s KOPB-om.
English: How is Trydonis used?
Croatian: Kako se Trydonis primjenjuje?
English: The infusion should last 30 minutes.
Croatian: Infuzija treba trajati 30 minuta.
English: The full EPAR for Fasturtec can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Fasturtec nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Fasturtec is given immediately before or during the start of chemotherapy.
Croatian: Fasturtec se primjenjuje neposredno prije ili tijekom početka kemoterapije.
English: Other information about Fasturtec
Croatian: Ostale informacije o lijeku Fasturtec
English: Two of the studies were designed to define the best dose to use.
Croatian: Dva ispitivanja bila su osmišljena tako da utvrde najbolju dozu za primjenu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fasturtec on 23 February 2001.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Fasturtec na snazi u Europskoj uniji od 23. veljače 2001.
English: The recommended dose is 0.2 mg per kilogram body weight in both children and adults, given as a daily infusion for up to seven days.
Croatian: Preporučena doza iznosi 0,2 mg po kilogramu tjelesne težine kako u djece tako i u odraslih, a primjenjuje se kao dnevna infuzija tijekom razdoblja od najviše sedam dana.
English: The benefits of Fasturtec were first studied in three main studies involving a total of 293 patients, including adults and children.
Croatian: Koristi lijeka Fasturtec su po prvi put ispitane u tri glavna ispitivanja, koja su obuhvatila ukupno 293 bolesnika, uključujući odrasle osobe i djecu.
English: This is a summary of the European public assessment report (EPAR) for Fasturtec.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Fasturtec.
English: This study also showed improvement in kidney function.
Croatian: To je ispitivanje također pokazalo poboljšanje u funkciji bubrega.
English: The most common side effects with Fasturtec (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, headache, fever and diarrhoea.
Croatian: Najčešće nuspojave povezane s lijekom Fasturtec (uočene u više od 1 bolesnika na 10) su mučnina (osjećaj slabosti), povraćanje, glavobolja, vrućica i proljev.
English: For more information about treatment with Fasturtec, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Fasturtec pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite se svom liječniku ili ljekarniku.
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 Fasturtec.
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 Fasturtec.
English: Fasturtec was not compared with another medicine in this study.
Croatian: U tom ispitivanju Fasturtec nije uspoređen s nekim drugim lijekom.
English: What is the risk associated with Fasturtec?
Croatian: Koji su rizici povezani s lijekom Fasturtec?
English: Fasturtec treatment should be supervised by a doctor who has been trained in the use of chemotherapy for blood cancers.
Croatian: Terapiju lijekom Fasturtec treba nadzirati liječnik koji je obučen za primjenu kemoterapije za karcinome krvi.
English: An additional study looked at the effects of Fasturtec in 21 children (aged between 6 months and 16 years) with blood cancers of whom 62% had uric acid levels that were too high.
Croatian: Dodatno ispitivanje istražilo je djelovanje lijeka Fasturtec u 21 djeteta (u dobi između 6 mjeseci i 16 godina) s rakom krvi od kojih je 62 % imalo previsoke koncentracije mokraćne kiseline.
English: Fasturtec must not be used in patients with a deficiency in (low levels of) glucose 6 phosphate dehydrogenase (G6PD) or other metabolic disorders known to cause haemolytic anaemia (low haemoglobin levels caused by the abnormal breakdown of red blood cells).
Croatian: Fasturtec se ne smije primjenjivati u bolesnika s deficijencijom (niskim koncentracijama) glukoze 6 fosfata dehidrogenaze (G6PD) ili drugih metaboličkih poremećaja za koje je poznato da uzrokuju hemolitičku anemiju (niske razine hemoglobina uzrokovane abnormalnom razgradnjom crvenih krvnih stanica).
English: The dose-finding studies showed that, after 48 hours, Fasturtec at a daily dose of 0.2 mg per kg reduced the uric acid levels to normal in 95% of patients.
Croatian: Ispitivanja provedena s ciljem utvrđivanja doze pokazala su da je nakon 48 sati lijek Fasturtec u dnevnoj dozi od 0,2 mg po kg smanjio koncentraciju mokraćne kiseline na normalnu u 95 % bolesnika.
English: In the additional study, none of the 21 children treated with Fasturtec had high uric acid levels after 24 or 48 hours.
Croatian: U dodatnom ispitivanju, nijedno od 21 djeteta liječenog lijekom Fasturtec nije imalo visoku koncentraciju mokraćne kiseline nakon 24 ili 48 sati.
English: Fasturtec rasburicase
Croatian: Fasturtec razburikaza
English: It is used in adults and children with blood cancers who are at risk of a sudden rise in uric acid levels when they start to receive chemotherapy (medicines to treat cancer).
Croatian: Koristi se u odraslih i djece s karcinomima krvi koji su izloženi riziku od iznenadnog povišenja koncentracija mokraćne kiseline nakon što počnu primati kemoterapiju (lijekove za liječenje raka).
English: The CHMP decided that Fasturtec's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Fasturtec nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The main measures of effectiveness were based on the reduction in blood uric acid levels.
Croatian: Glavni pokazatelji djelotvornosti temeljili su se na smanjenju razine mokraćne kiseline u krvi.
English: This helps to reduce the levels of uric acid in the blood, thereby reducing the load on the kidney and preventing any damage.
Croatian: Ovo pomaže pri smanjivanju razina mokraćne kiseline u krvi, te stoga smanjuje opterećenje bubrega i sprječava bilo kakvo oštećenje.
English: It is available as a powder and solvent that are made up into a solution for infusion (drip) into a vein.
Croatian: Dostupan je kao prašak i otapalo za koncentrat za otopinu za infuziju (drip) u venu.
English: What is Fasturtec?
Croatian: Što je Fasturtec?
English: Fasturtec was only compared with another treatment (allopurinol, the standard treatment for reducing uric acid levels) in one of the studies, which included 52 patients.
Croatian: Fasturtec je uspoređen s drugom terapijom (alopurinolom, standardnom terapijom za smanjivanje koncentracije mokraćne kiseline) u samo jednom ispitivanju koje je obuhvatilo 52 bolesnika.
English: In the comparative study, Fasturtec was more effective than allopurinol: over the first 96 hours after treatment, patients treated with Fasturtec had a lower average blood level of uric acid than the patients treated with allopurinol (128.1 and 328.5 mg.h/dl, respectively).
Croatian: U komparativnom ispitivanju, lijek Fasturtec bio je djelotvorniji od alopurinola: tijekom prvih 96 sati nakon terapije bolesnici liječeni lijekom Fasturtec imali su smanjene koncentracije mokraćne kiseline u krvi u odnosu na bolesnike liječene alopurinolom (128,1 odnosno 328,5 mg.h/dl).
English: The enzyme was originally extracted from a fungus, but in Fasturtec it is produced by a method known as ‘recombinant DNA technology': it is made by a yeast into which a gene (DNA) has been introduced that makes it able to produce urate oxidase.
Croatian: Enzim je izvorno ekstrahiran iz gljivice, no za potrebe lijeka Fasturtec proizvodi se metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: proizvodi se od kvasca u koji se uvodi gen (DNK) što omogućuje proizvodnju urat oksidaze.
English: Uric acid is a by-product of the breakdown of cells.
Croatian: Mokraćna kiselina popratni je proizvod razgradnje stanica.
English: Patients undergoing chemotherapy may be at risk of rapid tumour lysis, where many cancer cells are broken down at once causing a sudden rise of uric acid in the blood which can cause damage to the kidneys.
Croatian: Bolesnici koji primaju kemoterapiji mogu biti izloženi riziku od brze tumorske lize, pri čemu se mnogo stanica raka razgrađuje odjednom uzrokujući naglo povišenje mokraćne kiseline u krvi, što može uzrokovati oštećenje bubrega.
English: Fasturtec is used to treat and prevent high levels of uric acid in the blood in order to prevent kidney failure.
Croatian: Fasturtec se koristi za liječenje i profilaksu visoke koncentracije mokraćne kiseline u krvi radi prevencije zatajenja bubrega.
English: The duration of treatment is adjusted depending on the patient's blood levels of uric acid and the doctor's judgment.
Croatian: Trajanje terapije prilagođava se ovisno o koncentracijama mokraćne kiseline u krvi bolesnika i kliničkoj prosudbi.
English: What benefit has Fasturtec shown during the studies?
Croatian: Koje su koristi lijeka Fasturtec dokazane u ispitivanjima?
English: Fasturtec is a medicine that contains the active substance rasburicase.
Croatian: Fasturtec je lijek koji sadrži djelatnu tvar razburikazu.
English: The active substance in Fasturtec, rasburicase, is an enzyme called urate oxidase, which transforms uric acid into another chemical called allantoin, which can easily be excreted by the kidneys in the urine.
Croatian: Djelatna tvar lijeka Fasturtec, razburikaza, enzim je naziva urat oksidaza, koji pretvara mokraćnu kiselinu u drugu kemikaliju naziva alantoin, koji bubrezi mogu jednostavno izlučiti u urinu.
English: Why has Fasturtec been approved?
Croatian: Zašto je lijek Fasturtec odobren?
English: What is Fasturtec used for?
Croatian: Za što se Fasturtec koristi?
English: How is Fasturtec used?
Croatian: Kako se Fasturtec koristi?
English: For the full list of all side effects reported with Fasturtec, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Fasturtec potražite u uputi o lijeku.
English: How has Fasturtec been studied?
Croatian: Kako je Fasturtec ispitivan?
English: How does Fasturtec work?
Croatian: Kako djeluje Fasturtec?
English: 1 dose (0.5 ml) contains: Hepatitis B surface antigen 1, 2, 3
Croatian: 1 doza (0,5 ml) sadrži: površinski antigen Hepatitisa B 1, 2, 3
English: 2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Croatian: 2adsorbiran na aluminijev fosfat (0,5 miligrama Al3+ ukupno) 3proizveden na stanicama kvasca (Saccharomyces cerevisiae) tehnologijom rekombinantne DNA.
English: 1adjuvanted by AS04C containing: - 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 2
Croatian: 1uz dodatak adjuvansa AS04C koji sadrži: - 3-O-desacil-4'- monofosforil lipid A (MPL) 2
English: • The Committee considered the notification of the referral triggered by the Germany under Article 29(4) of Directive 2001/83/EC;
Croatian: • Povjerenstvo je razmotrilo obavijest o postupku upućivanja koji je pokrenula Njemačka sukladno članku 29. stavku 4. Direktive 2001/83/EZ.
English: On the other hand, if the particles are too large they would mostly remain trapped at the injection site and need too much time for transition to the lymph nodes, which is not practical.
Croatian: S druge strane, ako su čestice prevelike, ostaju uglavnom zarobljene u mjestu injekcije i potrebno im je previše vremena za prijelaz u limfne čvorove, što nije praktično.
English: If the subcutaneously injected particles are too small they “run” through the lymphatic system too quickly and disappear before imaging techniques can be applied.
Croatian: Ako su potkožno injektirane čestice premalene, prebrzo „protrče” kroz limfni sustav i nestanu prije primjene tehnike oslikavanja.
English: During development the MAH looked into the size distribution below 80 nm and created “particle size groups”.
Croatian: Tijekom razvoja, nositelji odobrenja razmotrili su distribuciju veličine manju od 80 nm i stvorili su „grupe veličina čestica”.
English: The MAH argued that the fluctuations per se are not clinically relevant and therefore differences between such fluctuations are not likely to pose a risk to public health.
Croatian: Nositelj odobrenja argumentirao je da fluktuacije per se nisu klinički relevantne, te stoga nije izgledno da će razlike u takvim fluktuacijama predstavljati rizik za javno zdravlje.
English: Filters at 15 nm, 30 nm, 50 nm and 80 nm filter pore size were used.
Croatian: Korišteni su filtri s veličinama filtarskih pora od 15 nm, 30 nm, 50 nm i 80 nm.
English: The mutual recognition marketing authorisation application (MAA) for Nanotop 0.5 mg, kit for radiopharmaceutical preparation / lyophilisate for suspension for injection was submitted on the basis of the marketing authorisation granted by Germany on 8th December 2011.
Croatian: Zahtjev za postupak međusobnog priznavanja odobrenja za stavljanje lijeka u promet za Nanotop 0,5 mg, komplet za radiofarmaceutičku pripremu / liofilizat za suspenziju za injekciju, dostavljen je na temelju odobrenja za stavljanje lijeka u promet kojeg je izdala Njemačka dana 8. prosinca 2011. godine.
English: In addition the MAH has provided data on Nanocoll and Nanotop batches that were analysed on four days (six batches), and on the same day.
Croatian: Nadalje, nositelj odobrenja dostavio je podatke o serijama lijekova Nanocoll i Nanotop koji su analizirani tijekom četiri dana (šest serija), te na isti dan.
English: Based on this, an optimal particle size range has been established for SLN detection.
Croatian: Na temelju toga, utvrđena je optimalna veličina čestica za detekciju SLN-a.
English: The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure.
Croatian: Stoga je CMDh uputio predmet CHMP-u putem postupka upućivanja u skladu sa člankom 29. stavkom 4.
English: The MAH has discussed particle size ranges and its implication for clinical practice in general, with reference to clinical guidelines.
Croatian: Nositelj odobrenja raspravio je raspone veličina čestica i općenito njihove implikacije za kliničku praksu, s referencom na kliničke smjernice.
English: In addition the MAH's clinical expert states that any variability in particle size within the specified range of Nanotop (≤ 80 nm of at least 95% of the particles) is not relevant for the clinical outcome.
Croatian: Nadalje, klinički stručnjak nositelja odobrenja navodi da bilo koja varijabilnost u veličini čestica u okviru specificiranog raspona lijeka Nanotop (≤ 80 nm od najmanje 95% čestica) nije relevantna za klinički ishod.
English: The legal basis for the submitted marketing authorisation application (MAA) was Article 10a "well established use", relying on appropriate scientific literature data of another similar product, Nanocoll.
Croatian: Pravna osnova za podnošenje zahtjeva za odobrenja za stavljanje lijeka u promet bila je „dobro utvrđena primjena” sukladno članku 10., što se oslanjalo na podatke iz odgovarajuće znanstvene literature za drugi sličan lijek, Nanocoll.
English: There have been no studies so far investigating the clinical effects of variability occurring within the particle size range of HSA nanocolloid (of 0 to 80 nm).
Croatian: Do sada nema provedenih ispitivanja koja su istražila kliničko djelovanje varijabilnosti koje nastupa u okviru raspona veličine čestica koloida nano veličine za HSA (od 0 do 80 nm).
English: Chakera et al. EANM-EORTC general recommendations for sentinel node diagnostics in melanoma.
Croatian: EANM-EORTC general recommendations for sentinel node diagnostics in melanoma.
English: The relevant quality attributes including upper particle size limits are defined in the European core summary of product characteristics (SmPC) for Tc-99m Albumin Microcolloid (nm), in the relevant European and national Treatment Guidelines1,2,3 and in the SmPC of the approved products (e.g. Nanocoll) and have been cited by the MAH.
Croatian: Relevantni atributi kvalitete, uključujući i gornja ograničenja veličine čestica definirani su u europskom ključnom sažetku opisa svojstava lijekova (SPCu) za Tc-99m koloid mikro veličine za albumin (nm), u relevantnim europskim i nacionalnim smjernicama za liječenje1,2,3 i u SPC-u za odobrene lijekove (primjerice Nanocoll), te su ih citirali nositelji odobrenja.
English: Overall summary of the scientific evaluation of Nanotop and associated names (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene lijeka Nanotop i povezanih naziva (vidjeti Prilog I.)
English: The particle size range is in this respect the crucial parameter that characterises the particular compound since small-sized colloids allow identification of a greater number of sentinel lymph nodes with a high statistical significance4.
Croatian: Raspon veličine čestica je u ovom smislu presudan parametar koji karakterizira poseban spoj s obzirom da koloidi malih veličina omogućuju identifikaciju većeg broja limfnih čvorova stražara s većim statističkim značajnom4.
English: Nanotop is a diagnostic radiopharmaceutical kit containing denatured human serum albumin (HSA), which after radiolabelling with Sodium Pertechnetate (99mTc) solution results in Technetium (99mTc) Nanocolloid.
Croatian: Nanotop je dijagnostički radiofarmaceutski komplet koji sadrži denaturirani ljudski serumski albumin (HSA), koji nakon radioaktivnog obilježavanja otopinom natrijevog pertehnetata (99mTc) rezultira tehnecij (99mTc) koloidom nano veličine.
English: During the CMDh referral procedure that followed, no consensus could be reached as Sweden maintained their objection that the importance of the batch variability for the distribution and uptake of Nanotop in lymph nodes, as well as its clinical implications had not been adequately addressed, as even a small difference in efficacy could represent a potential serious risk to public health.
Croatian: Tijekom postupka upućivanja CMDh-a koji je slijedio nakon toga, nije postignut konsenzus s obzirom da je Švedska zadržala svoj prigovor o značaju varijabilnosti serije lijeka za distribuciju i aktivni unos lijeka Nanotop u limfnim čvorovima, kao i da kliničke implikacije nisu primjereno razriješene, te da čak i male razlike u djelotvornosti mogu predstavljati potencijalan ozbiljan rizik za javno zdravlje.
English: During the mutual recognition procedure (MRP), major concerns were raised by the member states Sweden and France, that considering the batch variability, it was not possible from a quality perspective to conclude about the comparability between Nanotop and Nanocoll.
Croatian: Tijekom postupka međusobnog priznavanja (MRP), države članice Švedska i Francuska iznijele su ozbiljnu zabrinutost da s obzirom na varijabilnost serije nije moguće donijeti zaključke sa stajališta kvalitete u vezi s usporedivošću lijekova Nanotop i Nanocoll.
English: Since the references included in this submission were studies conducted with Nanocoll, the MAH provided arguments that these data are relevant for Nanotop.
Croatian: S obzirom da su reference uključene u ovaj podnesak bile ispitivanja provedena s lijekom Nanocoll, nositelj odobrenja dostavio je argumente da su ovi podaci od značaja za Nanotop.
English: The data provided by the MAH support the notion that variability may decrease when batches are analysed over a shorter period of time.
Croatian: Podaci koje je dostavio nositelj odobrenja idu u prilog prijedlogu da se varijabilnost može smanjiti prilikom analiziranja serija tijekom kraćeg vremenskog razdoblja.
English: In response to the objection that there is a difference in the data fluctuation between Nanotop and Nanocoll, the MAH has provided data to show that the fluctuations observed are comparable and that particle size group distribution is comparable between Nanotop and Nanocoll.
Croatian: U odgovoru na primjedbu da postoji razlika u fluktuaciji podataka između lijekova Nanotop i Nanocoll, nositelj odobrenja dostavio je podatke koji dokazuju da su uočene fluktuacije usporedive te da je distribucija grupa veličina čestica usporediva između lijekova Nanotop i Nanocoll.
English: Considering the particle size and the particle size ranges range discussed above, the CHMP was of the view that Nanotop is comparable to Nanocoll - the product referred to in the submitted literature, and that therefore an impact on clinical efficacy is not expected.
Croatian: S obzirom na prethodno razmatrane veličine čestica i raspone veličina čestica, mišljenje je CHMP-a da je Nanotop usporediv s lijekom Nanocoll - lijekom navedenim u dostavljenoj literature, te se stoga ne očekuje utjecaj na kliničku djelotvornost.
English: 1 Buscombe et al. Sentinel node in breast cancer procedural guidelines.
Croatian: Sentinel node in breast cancer procedural guidelines.