FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP agreed that the strength of the active substance enoxaparin will now be expressed both in international units (IU) and in milligram (mg) throughout the product information.
Croatian: CHMP se složio da će se u cijelom tekstu informacija o lijeku jačina djelatne tvari enoksaparina izražavati i u međunarodnim jedinicama (IU) i u miligramima (MG).
English: Lovenox contains the active substance enoxaparin.
Croatian: Lovenox sadrži djelatnu tvar enoksaparin.
English: • to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.
Croatian: • za sprječavanje nastanka ugrušaka kada krv cirkulira kroz uređaj za hemodijalizu radi uklanjanja otrovnih tvari.
English: Lovenox is authorised in the EU via national procedures.
Croatian: Lovenox je u Europskoj uniji odobren nacionalnim postupcima.
English: It is available as vials, ampoules, prefilled syringes and pens and is given by injection under the skin or into a vein.
Croatian: Dostupan je u bočicama, ampulama, napunjenim štrcaljkama i brizgalicama, a daje se injekcijom pod kožu ili u venu.
English: For the treatment of deep vein thrombosis and pulmonary embolism, the CHMP also clarified that the dose regimen of 150 IU/kg (1.5 mg/kg) given once daily should only be used only in uncomplicated patients who have a low risk of a further venous thromboembolism.
Croatian: CHMP je također razjasnio da se za liječenje duboke venske tromboze i plućne embolije režim doze od 150 IU/kg (1,5 mg/kg) jednom dnevno treba primjenjivati samo u bolesnika koji su jednostavni slučajevi s malim rizikom od daljnje venske tromboembolije.
English: On 12 November 2015, France referred the matter to the CHMP in order to harmonise the marketing authorisations for Lovenox in the EU.
Croatian: Francuska je 12. studenoga 2015. uputila predmet CHMP-u radi usklađivanja odobrenja za stavljanje u promet lijeka Lovenox u Europskoj uniji.
English: Lovenox is an anticoagulant medicine (a medicine to prevent blood clots) used in adults to prevent and treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg), as well as unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart) and certain types of myocardial infarction (heart attack);
Croatian: Lovenox je antikoagulacijski lijek (lijek za sprječavanje nastanka krvnih ugrušaka) koji se primjenjuje u odraslih za sprječavanje i liječenje bolesti povezanih s krvnim ugrušcima kao što je duboka venska tromboza (kada se u dubokoj veni razvije ugrušak, obično u nozi), a također i nestabilna angina (teška vrsta bola u prsima prouzročenog tegobama s dotokom krvi u srce) i nekim vrstama infarkta miokarda (srčani udar);
English: The CHMP, in light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: U svjetlu dostavljenih podataka i znanstvene rasprave unutar Odbora, mišljenje je CHMP-a da se sažeci opisa svojstava lijekova, označivanje i upute za lijekove moraju uskladiti na razini EU-a.
English: • to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they have reduced mobility due to illness;
Croatian: • za sprječavanje venske tromboembolije (krvnih ugrušaka koji nastaju unutar vena i ometaju protok krvi), posebice u bolesnika koji se podvrgavaju kirurškom zahvatu ili u kojih je rizik od stvaranja ugrušaka veći zbog smanjene pokretljivosti uzrokovane bolešću;
English: On 15 December 2016, the European Medicines Agency completed a review of Lovenox and associated names.
Croatian: Europska agencija za lijekove završila je ocjenjivanje lijeka Lovenox i pridruženih naziva 15. prosinca 2016.
English: • to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
Croatian: • za liječenje nestabilne angine pektoris (teška vrsta bola u prsima prouzročenog tegobama s dotokom krvi u srce);
English: • to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg) or pulmonary embolism (clot in a blood vessel supplying the lung);
Croatian: • za liječenje bolesti povezanih s krvnim ugrušcima kao što je duboka venska tromboza (pri kojoj krvni ugrušak nastaje u dubokoj veni, obično u nozi) ili plućna embolija (krvni ugrušak u krvnoj žili koja opskrbljuje pluća);
English: EMA/837288/2016 Rev.1 EMEA/H/A-30/1429
Croatian: EMA/837288/2016 Rev.
English: Lovenox was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska skupina za postupak međusobnog priznavanja i decentralizirani postupak za lijekove za primjenu u ljudi (CMDh) ustanovila je da je za lijek Lovenox potrebno provesti usklađivanje.
English: Sufficient evidence of efficacy in this patient population is available.
Croatian: Dostupno je dovoljno dokaza o djelotvornosti u toj populaciji bolesnika.
English: In case of repeated treatment, physicians should be aware of the risk, and manage their patients adequately.
Croatian: U slučaju ponovljenog liječenja, liječnici trebaju biti svjesni rizika i odgovarajuće liječiti svoje bolesnike.
English: A CHMP scientific advisory group (SAG) meeting was held in October 2011 and its views were considered by the CHMP in the framework of this review.
Croatian: Sastanak znanstveno savjetodavne skupine (SAG) CHMP-a održan je u listopadu 2011. i njena mišljenja CHMP obrazlaže u okviru ovog dokumenta.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I).
Croatian: • Povjerenstvo je razmotrilo postupak opisan u članku 31 Direktive 2001/83/EZ za aprotinin, aminokaproičnu kiselinu i traneksamičnu kiselinu (vidjeti Dodatak I).
English: In this regard, a study on the profile of aprotinin use is needed, particularly in light of the importance of adequate anticoagulation.
Croatian: U tom smislu, potrebno je provesti ispitivanje profila primjene aprotinina, a osobito s obzirom na važnost adekvatne antikoagulacije.
English: This document presents the conclusions on aprotinin.
Croatian: Ovaj dokument iznosi zaključke koji se odnose na aprotinin.
English: Divergent positions are appended to the Opinion.
Croatian: Mišljenju su pridodani različiti stavovi.
English: Aprotinin should only be used after careful consideration of the benefits and risks, and the consideration that alternative treatments are available (see section 4.4 and 5.1).
Croatian: Aprotinin treba primjenjivati samo nakon pažljive procjene koristi i rizika te razmatranja jesu li mogući drugi oblici liječenja (vidjeti dio 4.4 i 5.1).
English: In addition, results from observational studies are conflicting.
Croatian: Osim toga, studije opažanja dale su konfliktne rezultate.
English: Re-surgery due to bleeding carries high risk for increased morbidity which also was emphasised by the group of external experts consulted by the CHMP.
Croatian: Ponovni kirurški zahvat zbog krvarenja nosi visoki rizik od povećanog morbiditeta, što je također naglasila skupina vanjskih stručnjaka koju je konzultirao CHMP.
English: There are no indications that the efficacy would vary by age or that the safety pattern of aprotinin would be different in elderly patients as compared to the overall study populations.
Croatian: Nema indikacija da djelotvornost varira s dobi ili da je profil sigurnosti aprotinina različit u starijih bolesnika u usporedbi s cjelokupnom ispitivanom populacijom.
English: Several data sources informed the opinion of the Committee, including available data from clinical studies, published literature, spontaneous reports and other data submitted by marketing authorisation holders (MAHs) of medicinal products containing aprotinin, EACA or TXA.
Croatian: Nekoliko izvora podataka prenijelo je mišljenje Povjerenstva, uključujući dostupne podatke iz kliničkih ispitivanja, objavljene literature, spontanih izvještaja i drugih podataka koje su podnijeli nositelji odobrenja (MAH) za lijekove koji sadrže aprotinin, EACA ili TXA.
English: The CHMP noted the uncertainties and advised that the interpretation of all available data from observational studies is limited.
Croatian: CHMP je uočio te nesigurnosti i ustvrdio da je interpretacija svih raspoloživih podataka iz studija opažanja ograničena.
English: The MAHs will submit a revised protocol for the registry to national competent authorities.
Croatian: Nositelji odobrenja podnijet će revidirani protokol vođenja registra nacionalnim nadležnim tijelima.
English: It has a broad action on proteolytic enzymes such as plasmin, trypsin, and kallikrein.
Croatian: Ima široko djelovanje na proteolitičke enzime kao što su plazmin, tripsin i kalikrein.
English: The observational studies have provided conflicting results related to mortality as discussed above.
Croatian: Studije opažanja dale su konfliktne rezultate s obzirom smrtnost kako je prethodno opisano.
English: In addition, aprotinin should be used only in adult patients (data in children are not available) who are at ‘high-risk' of major blood loss.
Croatian: Osim toga aprotinin treba primjenjivati samo u odraslih bolesnika (nema podataka za djecu) za koje postoji visoki rizik od velikog gubitka krvi.
English: Aprotinin, a naturally occurring polypeptide, is an inhibitor of proteolytic enzymes.
Croatian: Aprotinin, prirodni polipeptid, inhibitor je proteolitičkih enzima.
English: The lysine analogues epsilon aminocaproic acid (EACA, also referred as aminocaproic acid) and tranexamic acid (TXA) inhibit more specifically the conversion of plasminogen to plasmin.
Croatian: Analozi lizina, epsilon aminokraproična kiselina (EACA, navodi se i kao aminokaproična kiselina) i traneksamična kiselina (TXA) specifičnije inhibiraju konverziju plazminogena u plazmin.
English: In the initial review in 2007 concerns had also been raised by the findings of three observational studies.
Croatian: U prvoj reviziji 2007. godine zabrinutost su također potaknuli nalazi triju studija opažanja.
English: All risks should be captured in the risk management plan.
Croatian: Sve rizike valja obuhvatiti planom upravlja rizicima.
English: The final results of BART study have since become available, together with important new analysis of the study data.
Croatian: Konačni rezultati ispitivanja BART otada su postali dostupni, zajedno s važnim novim analizama podataka ispitivanja.
English: Anaphylactic reactions are another well-known adverse effect that primarily occurs after repeated treatment.
Croatian: Anafilaktične reakcije drugi su dobro poznati štetni učinak koji se prvenstveno javlja nakon ponovljenog liječenja.
English: The CHMP considered that all of these risks, along with the uncertainties on the findings from clinical trials and observational studies on mortality, should be appropriately reflected through warnings and recommendations in the product information and captured in the risk management plan.
Croatian: CHMP smatra da se svi ti rizici, zajedno s nesigurnostima u vezi s nalazima kliničkih ispitivanja i studija opažanja o smrtnosti, trebaju biti odgovarajuće iskazani kroz upozorenja i preporuke u informaciji o lijeku i prikazani u planu upravljanja rizikom.
English: Recommendations on adequate monitoring of the anticoagulative effect of heparin administered in the CABG procedure should be reflected in the product information.
Croatian: Preporuke o odgovarajućem nadzoru antikoagulacijskog učinka heparina primijenjenog u postupku CABG trebaju se odražavati u informaciji o lijeku.
English: The conditions with regard to the safe and effective use of the medicinal product to be implemented by the member states are set out in annex IV of the opinion.
Croatian: Uvjeti s obzirom na sigurnu i djelotvornu upotrebu lijeka koje trebaju ispuniti zemlje članice određeni su u Dodatku IV mišljenja.
English: Taking into account all the data available on the efficacy and safety of aprotinin to date, the CHMP considered that there is clear evidence of a patient population in which the efficacy of systemic aprotinin clearly outweighs its risks.
Croatian: Uzimajući u obzir sve podatke o djelotvornosti i sigurnosti aprotinina dostupne do danas, CHMP smatra da postoji jasan dokaz za populaciju bolesnika u kojoj djelotvornost sistemskog aprotinina jasno nadilazi njegove rizike.
English: The product has been used outside its indication, with several trials where risks were observed conducted in a wider patient population.
Croatian: Lijek se upotrebljavao izvan svoje indikacije i rizici su opaženi u nekoliko ispitivanja provedenih u široj populaciji bolesnika.
English: All risks of aprotinin known to date were considered.
Croatian: Razmotreni su svi do danas poznati rizici aprotinina.
English: Separate opinions and conclusions were issued by the CHMP for the three antifibrinolytics (aprotinin, EACA and TXA).
Croatian: CHMP je izdao odvojena mišljenja i zaključke za tri antifibrinolitika (aprotinin, EACA i TXA).
English: • The Committee considered that the product information should be updated to ensure that the information to healthcare professionals and patients is up-to-date.
Croatian: • Povjerenstvo smatra da informacije o proizvodu treba ažurirati kako bi se zajamčilo da će zdravstveni djelatnici dobiti najnovije informacije.
English: The new data available to date however showed that the indication, and other sections of the product information, merited change, to take due account of known risks and the uncertainties associated with such risks.
Croatian: Međutim, novi podaci koji su danas dostupni pokazali su da indikacija i drugi dijelovi informacije o lijeku zaslužuju promjenu te da se pri tome na odgovarajući način uzmu u obzir poznati rizici i nepredviđeni događaji povezani s takvim rizicima.
English: A comprehensive review was undertaken and the CHMP concluded that the final BART study results were seriously compromised by several newly identified major methodological deficiencies, which were considered crucial to the validity and interpretation of the results.
Croatian: Pristupilo se sveobuhvatnoj reviziji i CHMP je zaključio da konačne rezultate ispitivanja BART ozbiljno ugrožava nekoliko novo ustanovljenih velikih metodoloških nedostataka koji se smatraju ključnim za vjerodostojnost i interpretaciju rezultata.
English: The results of re-analysis of two of these studies did not show a statistically significant association between aprotinin treatment and myocardial infarction, and other cardiovascular endpoints; methodological questions were raised over a third observational study where a supplementary analysis also did not show a significant association between aprotinin and seven-day in-hospital mortality.
Croatian: Rezultati ponovne analize dviju od tih studija nisu pokazale statistički značajnu povezanost između terapije aprotininom i infarkta miokarda i drugih kardiovaskularnih ishoda; postavljala su se metodološka pitanja za treću studiju opažanja u kojoj dodatna analiza također nije pokazala značajnu povezanost između aprotinina i bolničke smrtnosti tijekom sedam dana.
English: Whereas
Croatian: I
English: The number of patients who receive aprotinin, indication for administration, patient characteristics and risk factors and conditions of use including data on heparinisation of patients treated with aprotinin are some of the information to be collected.
Croatian: Broj bolesnika koji prime aprotinin, indikacija za primjenu, značajke bolesnika i čimbenici rizika te uvjeti upotrebe uključujući podatke o heparinizaciji bolesnika liječenih aprotininom, neki su od podataka koji će se prikupljati.
English: No firm conclusion on cardiovascular risks can be made on the BART study due to several serious methodological issues identified.
Croatian: Na temelju ispitivanja BART ne može se stvoriti čvrsti zaključak o kardiovaskularnim rizicima, zbog nekoliko ustanovljenih ozbiljnih metodoloških teškoća.
English: In addition, a registry must be conducted by MAHs of aprotinin containing medicinal products in order to gather more information on the profile of aprotinin use.
Croatian: Osim toga, nositelji odobrenja trebaju provoditi ispitivanje (registar) za lijekove koji sadrže aprotinin kako bi se prikupilo više informacija o profilu upotrebe aprotinina.
English: As a result, the Committee agreed on the lifting of the suspension for aprotinin with the balance of risks and benefits considered positive in the following revised indication for aprotinin:
Croatian: Kao rezultat, Povjerenstvo se složilo skinuti suspenziju za aprotinin, s tim da se omjer rizika i koristi smatra pozitivnim, u sljedećoj revidiranoj indikaciji aprotinina:
English: These concerns echoed those of a few published observational studies.
Croatian: Ti su razlozi za zabrinutost odražavali ono što je objavljeno u nekoliko studija opažanja.
English: The marketing authorisations for aprotinin were suspended following the preliminary results of the BART study in 2007, and concerns raised over some observational studies.
Croatian: Odobrenje za aprotinin bilo je suspendirano nakon preliminarnih rezultata ispitivanja BART 2007. godine te razloga za zabrinutost potaknutih nekim studijama opažanja.
English: The deficiencies included the unexplained exclusion of patients from analysis, underlying differences in baseline characteristics between the study groups which were not homogenous in spite of randomisation, and the apparent reduced level of heparinisation in the aprotinin arm which would increase the risk of thrombogenic events in this group.
Croatian: Nedostaci su uključivali neobjašnjivo isključivanje bolesnika iz analize, osnovne razlike u početnim karakteristikama između ispitivanih skupina koje nisu bile homogene usprkos randomizaciji i vidljivo smanjenu razinu heparinizacije u skupini koja je primala aprotinin, što bi povećalo rizik od trombogenih događaja u toj skupini.
English: • The CHMP concluded that the BART data and the signal on increased mortality associated with aprotinin compared to EACA and TXA were not considered reliable, based on the totality of evidence now available since the review of aprotinin undertaken in 2007, including more recent observational studies, the new analyses of the BART study data and the identified major study flaws, and taking the advice of the SAG into account.
Croatian: • CHMP je zaključilo da se podaci ispitivanja BART i upozorenje o povećanoj smrtnosti povezanoj s aprotininom u usporedbi s EACA i TXA ne smatraju pouzdanima na temelju sveukupnih sada dostupnih dokaza prikupljenih od revizije aprotinina provedene 2007. godine, uključujući novije studije opažanja, nove analize podataka ispitivanja BART i ustanovljenih velikih nedostataka studije te uzimajući u obzir savjet znanstveno savjetodavne skupine.
English: These new data have now made it possible to identify the major flaws of the BART study, not identifiable before.
Croatian: Ti novi podaci sada su omogućili prepoznavanje velikih nedostataka ispitivanja BART, koji prije nisu bili opaženi.
English: Therefore the CHMP concluded that the balance of risks and benefits for aprotinin is positive under normal conditions of use subject to the revision of the indication as follows:
Croatian: Stoga CHMP zaključuje da je omjer rizika i koristi za aprotinin pozitivan u normalnim uvjetima upotrebe, uz reviziju indikacija kako slijedi:
English: New observational studies are now available and results showed that aprotinin did not affect in-hospital mortality, with one study reporting a statistically significant mortality ‘benefit' for aprotinin in high-risk cardiac surgery patients, compared with TXA.
Croatian: Sada su dostupna nove studije opažanja i rezultati su pokazali da aprotinin nije utjecao na bolničku smrtnost, s tim da je jedno ispitivanje u odnosu na smrtnost zabilježilo statistički značajnu 'korist' aprotinina u usporedbi s TXA u kardiokirurških bolesnika visokog rizika.
English: Based on the final results and new evidence from re-analysis of data pointing out the deficiencies of the study that emerged after finalisation of the BART study, the CHMP is of the opinion that these data are not reliable and cannot be considered with regards to the cardiovascular risks of aprotinin.
Croatian: Na temelju konačnih rezultata i novog dokaza ustanovljenog ponovnom analizom podataka nakon završetka ispitivanja BART koji ukazuje na nedostatke ispitivanja, CHMP smatra da ti podaci nisu pouzdani i ne mogu se uzeti u obzir u procjeni kardiovaskularnih rizika povezanih s aprotininom.
English: This is important to take into consideration when treating patients with known pre-existing impairment and in patients concomitantly treated with drugs that may affect renal function.
Croatian: To je važno uzeti u obzir pri liječenju bolesnika s poznatim otprije postojećim oštećenjem te u bolesnika istodobno liječenih lijekovima koji mogu utjecati na bubrežnu funkciju.
English: There is no evidence of an association between aprotinin and perioperative mortality from randomised clinical trials when the BART study is excluded.
Croatian: Nema dokaza o povezanosti između aprotinina i perioperacijske smrtnosti iz randomiziranih kliničkih ispitivanja kada je isključeno ispitivanje BART.
English: Other notable safety concerns include the identified risk for transient renal impairment, which is a well characterised unfavourable effect of treatment with aprotinin.
Croatian: Druga uočljiva sigurnosna pitanja uključuju identificiran rizik od prolaznog oštećenja bubrežne funkcije, što je dobro karakteriziran nepovoljni učinak liječenja aprotininom.
English: The CHMP considered that overall the data provided illustrate the risks associated with inadequate monitoring of the anticoagulative effect of heparin administered in the CABG procedure.
Croatian: CHMP smatra da sveukupno podaci ilustriraju rizike povezane s neodgovarajućim praćenjem antikoagulacijskog učinka heparina primijenjenog u postupku ugradnje aortokoronarne premosnice (CABG).
English: The CHMP considered that a clarification should be included in the wording of the indication to reflect that the product should be used in patients undergoing CPB in the course of ‘isolated CABG' surgery, as efficacy and safety of aprotinin in more extensive surgery has not been sufficiently characterised.
Croatian: CHMP smatra da u tekst indikacije treba uključiti objašnjenje koje će pokazati da lijek treba upotrebljavati u bolesnika u kojih se tijekom 'izoliranog zahvata CABG' primjenjuje kardiopulmonalna obilaznica, jer djelotvornost i sigurnost aprotinina u ekstenzivnijoj kirurgiji nije bila dostatno opisana.
English: A review of the product information was undertaken to specify the agreed target population and update the clinical part of the product information to ensure that the information to healthcare professionals and patients is up to date.
Croatian: Provedene su promjene informacija o lijeku kako bi se odredila dogovorena ciljna populacija i ažurirao klinički dio informacije o lijeku i time osiguralo da zdravstveni djelatnici i bolesnici dobiju najnovije informacije.
English: Therefore, taking the totality of data into account it is judged that the previous signal for an increased mortality associated with the use of aprotinin is refuted provided that aprotinin is given in the identified target population and the recommendations for its use are followed.
Croatian: Stoga, uzimajući u obzir sveukupne podatke, zaključeno je da se prijašnje upozorenje o povećanoj smrtnosti povezanoj s primjenom aprotinina odbaci, uz uvjet da se aprotinin primjenjuje u identificiranoj ciljnoj populaciji te uz pridržavanje preporuka za njegovu upotrebu.
English: Special attention is also to be given to patients with renal impairment and to the possible occurrence anaphylactic reactions.
Croatian: Posebnu pozornost treba usmjeriti na bolesnike s bubrežnim oštećenjem te mogućoj pojavi anafilaktičnih reakcija.