FrancophonIA/ELRC3.0 huggingface dataset:
English: • Total amount (ml) Vimizim divided by 5 ml per vial = Total number of vials 2.
Croatian: • Ukupna količina (ml) Vimizima podijeljena s 5 ml po jednoj bočici = ukupan broj bočica 2.
English: • Total amount (ml) Vimizim divided by 5 ml per vial = Total number of vials
Croatian: • Ukupna količina (ml) Vimizima podijeljena s 5 ml po jednoj bočici = ukupan broj bočica
English: When diluted with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion; the initial rate will be 3 ml/hr.
Croatian: Ako je lijek razrijeđen u 100 ml 0,9% otopine natrijevog klorida (9 mg/ml) za infuziju; početna brzina infuzije mora biti 3 ml/sat.
English: The clear to slightly opalescent and colourless to pale yellow solution must be free of visible particles.
Croatian: Bistra do blago opalescentna i bezbojna do blijedožuta otopina ne smije imati vidljivih čestica.
English: How to store Vimizim 6.
Croatian: Kako se primjenjuje Vimizim 4. Moguće nuspojave
English: Week 24 Change
Croatian: Promjena Početna vrijednost tjedan
English: A volume of the sodium chloride 9 mg/ml (0.9 %) solution for infusion is to be withdrawn and discarded from the infusion bag, equal to the volume of Vimizim concentrate to be added.
Croatian: Iz vrećice za infuziju s 0,9% otopinom natrijevog klorida potrebno je izvući i odbaciti volumen koji odgovara volumenu koncentrata Vimizima koji se dodaje.
English: A clear to slightly opalescent and colourless to pale yellow solution.
Croatian: Bistra do blago opalescentna i bezbojna do blijedožuta otopina.
English: Before withdrawing Vimizim from the vial, each vial is visually inspected for particulate matter and discoloration.
Croatian: Vimizima iz bočice, potrebno je vizualno provjeriti svaku bočicu radi eventualnog postojanja čestica i promjene boje.
English: Do not use if the solution is discoloured or if there is particulate matter in the solution.
Croatian: Nemojte primijeniti otopinu ako je promijenila boju ili ima čestica u otopini.
English: Patients weighing 25 kg or more should receive a total volume of 250 ml.
Croatian: Bolesnici s težinom od 25 kg ili većom moraju primiti ukupni volumen 250 ml infuzije.
English: • Patients weighing 25 kg or more should receive a total volume of 250 ml.
Croatian: • Bolesnici od 25 kg ili teži moraju primiti ukupni volumen od 250 ml.
English: Anaphylaxis and severe allergic reactions
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Anafilaksija i teške alergijske reakcije
English: IV use after dilution
Croatian: 4. Prije izvlačenja
English: Step 5 minutes (ml/hr)
Croatian: Korak 5 minuta (ml/sat)
English: Week 22 Mean (SD)
Croatian: 22. tjedan Srednja vrijednost (standardna devijacija)
English: OTHER
Croatian: Promjena
English: The infusion rate will be increased every 15 minutes as follows: first increase the rate to 12 ml/hr, then increase the rate every 15 minutes by 12 ml/hr increments until a maximum rate of 72 ml/hr is reached.
Croatian: Brzina infuzije treba se povećavati svakih 15 minuta kao što slijedi: prvo povećajte brzinu na 12 ml/sat, nakon toga povećavajte brzinu svakih 15 minuta za 12 ml/sat do postizanja maksimalne brzine primjene od 72 ml/sat.
English: Step 2 minutes (ml/hr)
Croatian: Korak 2 minuta (ml/sat)
English: • Patients weighing less than 25 kg should receive a total volume of 100 ml.
Croatian: • Bolesnici do 25 kg moraju primiti ukupni volumen od 100 ml.
English: Step 6 minutes (ml/hr)
Croatian: Korak 6 minuta (ml/sat)
English: Step 4 minutes (ml/hr)
Croatian: Korak 4 minuta (ml/sat)
English: The infusion rate will be increased every 15 minutes as follows: first increase the rate to 6 ml/hr, then increase the rate every 15 minutes by 6 ml/hr increments until a maximum rate of 36 ml/hr is reached.
Croatian: Brzina infuzije treba se povećavati svakih 15 minuta kao što slijedi: prvo povećajte brzinu na 6 ml/sat, nakon toga povećavajte brzinu svakih 15 minuta za 6 ml/sat do postizanja maksimalne brzine primjene od 36 ml/sat.
English: Dose
Croatian: SAD
English: Step 3 minutes (ml/hr)
Croatian: Korak 3 minuta (ml/sat)
English: 3-Minute stair climb test (stairs/minute)
Croatian: 3-minutni test penjanja stepenicama (stepenica/minuti) Srednja vrijednost  standardna devijacija
English: The infusion rate may be increased as tolerated, every 15 minutes as follows: first increase the rate to 12 ml/hr, then increase the rate every 15 minutes by 12 ml/hr increments until a maximum rate of 72 ml/hr is reached.
Croatian: Brzina infuzije može se povećavati, ako je bolesnik podnosi, svakih 15 minuta kako slijedi: prvo povećajte brzinu na 12 ml/sat, nakon toga povećajte brzinu svakih 15 minuta za po 12 ml/sat do postizanja maksimalne brzine od 72 ml/sat.
English: Sodium dihydrogen phosphate monohydrate; Arginine hydrochloride;
Croatian: natrijev acetat trihidrat, natrijev dihidrogenfosfat hidrat, argininklorid, sorbitol (E420), polisorbat 20, voda za injekcije,
English: The infusion rate may be increased as tolerated, every 15 minutes as follows: first increase the rate to 6 ml/hr, then increase the rate every 15 minutes by 6 ml/hr increments until a maximum rate of 36 ml/hr is reached.
Croatian: Brzina infuzije može se povećavati, ako je bolesnik podnosi, svakih 15 minuta kako slijedi: prvo povećajte brzinu na 6 ml/sat, nakon toga povećajte brzinu svakih 15 minuta za po 6 ml/sat do postizanja maksimalne brzine od 36 ml/sat.
English: Dyspnoea
Croatian: Omaglica
English: Musculoskeletal and connective Myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva
English: BioMarin International Limited Shanbally, Ringaskiddy County Cork
Croatian: Shanbally, Ringaskiddy
English: Step 7 minutes (ml/hr)
Croatian: Korak 7 Više od minuta (ml/sat)
English: Dish cells/cm²
Croatian: Zdjelica stanica/cm²
English: 1 to 2 implantation matrices
Croatian: 1 ili 2 matrice za implantaciju
English: EU (MA) number (Invented)
Croatian: Broj (EU) odobrenja
English: Furthermore, residual bias will always be present.
Croatian: Nadalje, rezidualni otklon uvijek će biti prisutan.
English: In general, it can be concluded that the safety profile seems well characterized.
Croatian: Općenito se može zaključiti da se sigurnosni profil čini dobro opisanim.
English: Although statin use increased during the study, it was only 28 - 29% at 6 months and 44 - 46% at 42 months.
Croatian: Iako se uporaba statina povećala tijekom ispitivanja, iznosila je samo 28 - 29 % nakon 6 mjeseci i 44 - 46 % nakon 42 mjeseca.
English: They are essential fatty acids and must be obtained from the diet.
Croatian: One su esencijalne masne kiseline i moraju se dobiti iz prehrane.
English: These results should, however, be interpreted with caution.
Croatian: Ove rezultate ipak treba tumačiti s oprezom.
English: Both submissions discussed the available data sources and their interpretation.
Croatian: U oba zahtjeva razmatraju se dostupni izvori podataka i njihovo tumačenje.
English: Therefore, it is considered that these studies are only supportive.
Croatian: Stoga se smatra da su ta ispitivanja samo potporna.
English: It should also be noted that the current European guidelines no longer recommend omega-3 supplementation in this indication.
Croatian: Također, treba napomenuti da sadašnje europske smjernice više ne preporučuju nadomjestak omega-3 u ovoj indikaciji.
English: It did not reproduce these findings and did not demonstrate efficacy in this indication.
Croatian: Ono nije ponovilo te rezultate i nije pokazalo djelotvornost u ovoj indikaciji.
English: These products contain 18 to 22 carbon atoms and a varying number of double bonds, the first of which is in the n-3 position.
Croatian: Ovi lijekovi sadrže od 18 do 22 atoma ugljika i različit broj dvostrukih veza, od kojih je prvi u položaju n-3.
English: Based on the results, there is only a 2.5% chance that the relative risk reduction for MACE exceeds 4%.
Croatian: Prema rezultatima, samo je 2,5 % izgleda da smanjenje relativnog rizika za MACE premaši 4 %.
English: It has also been argued that the OMEGA trial had a too short duration (12 months) to observe beneficial effects.
Croatian: Također se tvrdilo da je ispitivanje OMEGA trajalo prekratko (12 mjeseci) da bi se uočili korisni učinci.
English: With any other interpretation about the primary endpoints, multiplicity should have been controlled, which was not the case.
Croatian: Uz bilo koje drugo tumačenje mjera primarnih ishoda, mnogostrukost je trebala biti kontrolirana, a to nije bio slučaj.
English: However, in the GISSI-P trial, the effect was most pronounced at earlier time points (<12 months) with no increase thereafter.
Croatian: Međutim, u ispitivanju GISSI-P, učinak je bio najizraženiji u početnim vremenskim točkama (< 12 mjeseci), a kasnije se nije povećavao.
English: Propensity score matching was incomplete or even not attempted.
Croatian: Uparivanje prema sklonosti (eng. „propensity score matching”) nije bilo potpuno ili se čak nije ni pokušavalo provesti.
English: The recommendations in these guidelines are therefore developed after careful consideration of the scientific and medical knowledge and evidence available at the time of coming into effect.
Croatian: Stoga su preporuke sadržane u tim smjernicama rezultat pažljivog razmatranja znanstvenih i medicinskih saznanja i dokaza, dostupnih u trenutku stupanja smjernica na snagu.
English: The efficacy in this indication was not demonstrated in subsequent and more robust clinical trials.
Croatian: Djelotvornost u ovoj indikaciji nije dokazana u kasnijim i robusnijim kliničkim ispitivanjima.
English: The narrow confidence interval excludes any clinically relevant beneficial effects.
Croatian: Uzak interval pouzdanosti isključuje sve klinički važne korisne učinke.
English: This study suffers from some methodological limitations and results should be interpreted with caution.
Croatian: Ovo ispitivanje ima određena metodološka ograničenja pa rezultate treba tumačiti s oprezom.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the variation of the marketing authorisations.
Croatian: Direktive 2001/83/EZ, Odbor preporučuje izmjenu odobrenja za stavljanje lijeka u promet.
English: Since this was not the case, these can be considered supportive for a lack of efficacy.
Croatian: Budući da to nije bio slučaj, može se smatrati da ta ispitivanja govore u prilog nedostatku djelotvornosti.
English: Based on these limitations, the results of the cohort studies are not considered to override the results of the randomized trials referred to above.
Croatian: Na temelju ovih ograničenja, smatra se da rezultati kohortnih ispitivanja ne nadjačavaju rezultate navedenih randomiziranih ispitivanja.
English: The study formally failed because the primary analysis of one of the coprimary endpoints did not show a statistically significant difference.
Croatian: Ispitivanje formalno nije uspjelo jer primarna analiza jedne od mjera koprimarnih ishoda nije pokazala statistički značajnu razliku.
English: Therefore, the proposed modification of the indication is not acceptable by the CHMP.
Croatian: Stoga CHMP smatra da predložena promjena indikacije nije prihvatljiva.
English: Kotwall et al. Omega 3 Fatty acids and Cardiovascular Outcomes Systematic and Meta-Analysis, Circ Cardiovasc Qual Outcomes 2012;5:808-818
Croatian: Omega 3 Fatty acids and Cardiovascular Outcomes Systematic and Meta-Analysis, Circ Cardiovasc Qual Outcomes 2012;5:808-818
English: No attempts have been made to adjust for likely differences between centers regarding strategies and ambition for secondary prevention, likely creating correlations within centers.
Croatian: pokušaja da se moguće razlike između centara u pogledu strategija i ambicija za sekundarnu prevenciju prilagode, što bi vjerojatno dovelo do povezanosti unutar centara.
English: In addition, less than 5% of the patients included in this study received optimal baseline therapy over the whole study period which questions the results in the context of current secondary therapy recommendations.
Croatian: Nadalje, manje od 5 % bolesnika uključenih u ovo ispitivanje primalo je optimalnu osnovnu terapiju tijekom cijelog razdoblja ispitivanja, što dovodi u pitanje rezultate u kontekstu trenutačno važećih preporuka za sekundarnu terapiju.
English: Similar to OMEGA trial, a lack of effect of in this indication was observed.
Croatian: Slično kao i u ispitivanju OMEGA, opažen je nedostatak učinka u ovoj indikaciji.
English: They noted that this treatment is not recommended in the current guidelines for prevention of CVD by the European Society of Cardiology and the European Atherosclerosis Society.
Croatian: Napomenuli su da se takvo liječenje ne preporučuje u važećim smjernicama za sprječavanje kardiovaskularne bolesti Europskog kardiološkog društva i Europskog društva za aterosklerozu.
English: Two of the studies (Greene5 and Macchia6) included a large number of subjects and for the latter, the documented risk reduction for all-cause mortality was 37% (RR 0.63 CI 0.56-0.72).
Croatian: Dva ispitivanja (Greene5 i Macchia6) uključivala su veliki broj ispitanika, a za drugo od njih dokumentirano je smanjenje rizika od smrtnosti svih uzroka od 37 % (RR 0,63 CI 0,56 − 0,72).
English: The study is associated with some methodological limitations - this was an open label study where the control group did not receive study medication which may have influenced the results.
Croatian: Ispitivanje uključuje neka metodološka ograničenja - radilo se o otvorenom ispitivanju u kojem kontrolna skupina nije primala ispitivani lijek, što je možda utjecalo na rezultate.
English: In GISSI-P at the most, 5% of the patients received lipid lowering therapy over the whole period of the first year.
Croatian: U ispitivanju GISSI-P, najviše 5 % bolesnika primalo je terapiju za snižavanje lipida tijekom cijele prve godine.
English: Furthermore, ischaemic stroke is also most often caused by atherosclerosis.
Croatian: Nadalje, ishemijski moždani udar također je najčešće prouzročen aterosklerozom.
English: Vitamin E is not considered beneficial in the prophylaxis of cardiovascular events.
Croatian: Smatra se da vitamin E nije koristan u profilaksi kardiovaskularnih događaja.
English: It is considered that the study had co-primary endpoints and hierarchical primary and secondary endpoint analyses.
Croatian: Smatra se da je ispitivanje imalo koprimarne ishode i hijerarhijske analize primarnih i sekundarnih ishoda.
English: Studies in patients with an implantable cardioverter defibrillator (ICD) showed inconsistent results regarding antiarrhythmic efficacy (Leaf et al.8, 2005; Brouwer et al.9 2006, Raitt et al.10, 2005; Weisman et al.11, 2017).
Croatian: Ispitivanja provedena u bolesnika s ugradbenim kardioverterskim defibrilatorom (ICD) pokazala su nedosljedne rezultate u pogledu djelotvornosti protiv aritmija (Leaf et al.8, 2005; Brouwer et al.9 2006, Raitt et al.10, 2005; Weisman et al.11, 2017).
English: Thus, retrospective data in these studies did not allow for appropriate statistical adjustment for confounding.
Croatian: Prema tome, retrospektivni podatci u ovim ispitivanjima nisu omogućili odgovarajuću statističku prilagodbu u pogledu zbunjujuće varijable.
English: However, later studies, including meta-analyses1,2,3 have failed to show a beneficial effect in this condition.
Croatian: Međutim, kasnija ispitivanja, uključujući metaanalize1,2,3 , nisu uspjela pokazati koristan učinak u liječenju ove bolesti.
English: Furthermore, although this post-hoc analysis did not show differences in benefit with or without concomitant statin therapy, potential differences could not be excluded since the study was underpowered for demonstrating such differences.
Croatian: Nadalje, iako ta post hoc analiza nije pokazala razlike u dobrobiti lijeka uz istodobnu terapiju statinima ili bez nje, potencijalne razlike ne mogu se isključiti jer je ispitivanje bilo premale snage da takve razlike pokaže.
English: They also inhibit very-low-density lipoprotein (VLDL) synthesis in the liver, which reduces triglyceride concentrations.
Croatian: One također inhibiraju sintezu lipoproteina vrlo niske gustoće (VLDL) u jetri, što smanjuje koncentracije triglicerida.
English: Especially selection bias is of concern, as it can be envisaged that omega-3 fatty acids will be prescribed to certain patients (not needing strict treatment immediately).
Croatian: Posebno je zabrinjavajući otklon zbog pristranog izbora ispitanika, jer se može predvidjeti da će omega-3 masne kiseline biti propisivane određenim bolesnicima (kojima nije odmah potrebno strogo određeno liječenje).
English: • The OMEGA trial (performed in 2010 after the original approval of the secondary prevention indication) was a well performed, double blind trial evaluating a population well representative of the currently approved secondary prevention indication, including the use of standard of care treatment.
Croatian: • Ispitivanje OMEGA (provedeno 2010. godine nakon prvobitnog odobrenja indikacije sekundarne prevencije) bilo je dobro provedeno, dvostruko slijepo ispitivanje u kojem se procjenjivala populacija koja je bila zadovoljavajuće reprezentativna za trenutačno odobrenu indikaciju sekundarne prevencije, uključujući i liječenje standardnom skrbi.
English: • It has been hypothesised that the results of the GISSI-P trial was driven by a reduced risk of sudden death, potentially based on an antiarrhythmic effect of omega-3.
Croatian: • Pretpostavlja se da su rezultati GISSI-P ispitivanja bili potaknuti smanjenim rizikom od iznenadne smrti, koji su se potencijalno temeljili na antiaritmičkom učinku omega-3.
English: • The CHMP considered that, even though it is acknowledged that the GISSI-P clinical trial was the basis for the original approval of the secondary prevention indication in the light of more recent data and information, the study is considered to have some serious limitations that cast doubts on the results.
Croatian: • CHMP smatra da, iako je priznato da je kliničko ispitivanje GISSI-P bilo osnova za prvobitno davanje odobrenja u indikaciji sekundarne prevencije, u svjetlu novijih podatka i informacija smatra se da ispitivanje ima stanovita ozbiljna ograničenja koja rezultate dovode u sumnju.
English: Following the adoption of the CHMP opinion in December 2018, a re-examination request was received from the MAHs involved in the procedure, BASF AS (representing Mylan Hrvatska D.O.O, BGP Products Ltd, Ferrer-Galenica S.A and Strides Arcolab International Limited) and ALFASIGMA S.p.A (on behalf of DOC GENERICI S.r.l., EG S.p.A., IBSA FARMACEUTICI ITALIA S.r.l., PFIZER ITALIA S.r.l., SPA SOCIETÀ PRODOTTI ANTIBIOTICI S.p.A.).
Croatian: Nakon prihvaćanja mišljenja CHMP-a u prosincu 2018., zahtjev za preispitivanje mišljenja uputili su nositelji odobrenja za stavljanje lijeka u promet uključeni u postupak: BASF AS (predstavlja tvrtke Mylan Hrvatska D.O.O, BGP Products Ltd, Ferrer-Galenica S.A i Strides Arcolab International Limited) i ALFASIGMA S.p.A (u ime DOC GENERICI S.r.l., EG S.p.A., IBSA FARMACEUTICI ITALIA S.r.l., PFIZER ITALIA S.r.l., SPA SOCIETÀ PRODOTTI ANTIBIOTICI S.p.A.).
English: The OMEGA trial was a large prospective, double blind, randomized study including a population highly representative of the target population including the use of standard of care treatment.
Croatian: Ispitivanje OMEGA bilo je veliko prospektivno, dvostruko slijepo, randomizirano ispitivanje koje je obuhvatilo populaciju visoko reprezentativnu za ciljnu populaciju, uključujući liječenje standardnom skrbi.
English: With respect to safety, the PRAC concluded in the last PSUSA (January 2017) that no new safety issues had emerged.
Croatian: S obzirom na sigurnost, u posljednjem postupku PSUSA (siječanj 2017.) Odbor za procjenu rizika u području farmakovigilancije (PRAC) zaključio je da se nisu pojavila nova pitanja sigurnosti.
English: Therefore omega-3 fatty acids are also termed n-3 polyunsaturated fatty acids (n-3 PUFA).
Croatian: Stoga se omega-3 masne kiseline nazivaju i n-3 polinezasićene masne kiseline (n-3 PUFA).
English: The therapeutic effect of omega-3 fatty acids has been attributed to their possible involvement on eicosanoid balance, lipid metabolism, and cell membranes.
Croatian: Terapijski učinak omega-3 masnih kiselina pripisuje se njihovom mogućem djelovanju na ravnotežu eikosanoida, metabolizam lipida i stanične membrane.
English: These limitations include the open-label study design with no study medication in the control arm, the small magnitude of effect, the unusual and unexpected observation of an effect on fatal cardiovascular events only in the absence of any effect on non-fatal events and poor precision of the results.
Croatian: Ta se ograničenja odnose na nacrt otvorenog ispitivanja bez ispitivanog lijeka u kontrolnoj skupini, mali opseg učinka, neobično i neočekivano opažanje učinka samo u slučaju smrtonosnih kardiovaskularnih događaja, a nepostojanje učinka u slučaju događaja koji nisu smrtonosni te lošu preciznost rezultata.
English: This potential positive effect on mortality has not been reproduced in subsequent trials and the antiarrhythmic effect has not been confirmed in trials examining patients with ICD.
Croatian: Ovaj potencijalni pozitivni učinak na smrtnost nije ponovljen u kasnijim ispitivanjima, a antiaritmički učinak nije potvrđen u ispitivanjima koja su obuhvaćala bolesnike s ugradbenim kardioverterskim defibrilatorom.
English: • As a consequence, the CHMP considered that the indication “Secondary prevention after myocardial infarction” at the dose of 1 g/day should be deleted with additional consequential changes in the product information.
Croatian: • Posljedično tomu, CHMP smatra da indikaciju „sekundarna prevencija nakon infarkta miokarda” u dozi od 1 g na dan treba izbrisati, a u informacije o lijeku unijeti dodatne promjene koje iz toga proizlaze.
English: actually reflect biologically plausible effects or more likely reflect a selection bias problem.
Croatian: Neki od rezultata dovode u sumnju pokazuju li opažene povezanosti stvarno biološki prihvatljive učinke ili, vjerojatnije, odražavaju problem pristranog izbora ispitanika.
English: The experts agreed that there is no sign of harm in the totality of data, but that the beneficial effect of omega-3s may be questioned.
Croatian: Stručnjaci su se složili da u ukupnim podatcima nema znaka škodljivosti, ali je koristan učinak omega-3 masnih kiselina možda upitan.
English: Therefore, the CHMP considers that the validity of the meta-analyses is rather limited and that the meta-analyses can only be interpreted as being indicative, but not conclusive, with regards to potential efficacy or the lack of efficacy of omega-3 fatty acids in reducing the risk of cardiovascular events.
Croatian: Stoga CHMP smatra da je valjanost metaanaliza prilično ograničena i da se metaanalize mogu tumačiti samo kao indikativne ali ne i konačne u pogledu potencijalne djelotvornosti ili nedostatka djelotvornosti omega-3 masnih kiselina za smanjenje rizika od kardiovaskularnih događaja.
English: If there was a relevant beneficial antiarrhythmic effect of omega-3 acid ethyl esters, as has been stated, it should also have been relevant for those patient populations at increased cardiovascular risk included in these studies.
Croatian: Da je ustanovljen relevantan koristan antiaritmički učinak etilnih estera omega-3 kiselina, kao što je navedeno, taj bi učinak bio relevantan i za populacije bolesnika s povećanim kardiovaskularnim rizikom koje su bile uključene u ova ispitivanja.
English: The MAHs citation of relevant guideline "included clinical trials need to be longterm controlled (usually 12 months or longer), parallel and preferably double-blind" is correct.
Croatian: Nositelji odobrenja za stavljanje u promet točno navode da prema relevantnoj smjernici „uključena klinička ispitivanja moraju biti dugoročno kontrolirana (obično 12 mjeseci ili dulje), usporedna i po mogućnosti dvostruko slijepa”.