natgillin/translations-raw huggingface dataset:
The company that markets these medicines is Sanofi. 
Ta zdravila trži farmacevtska družba Sanofi.
It is available as vials, ampoules, prefilled syringes and pens and is given by injection under the skin or into a vein. 
Na voljo je v obliki vial, ampul, napolnjenih injekcijskih brizg in peresnikov ter se daje z injekcijo v podkožje ali veno.
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. 
Odbor CHMP je na podlagi predloženih podatkov in znanstvene razprave v odboru menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti po vsej EU.
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. 
Odbor CHMP je soglašal, da bo jakost zdravilne učinkovine enoksaparina v informacijah o zdravilu od zdaj naprej izražena v mednarodnih enotah (i.e.) in miligramih (mg).
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); 
Lovenox je antikoagulacijsko zdravilo (zdravilo za preprečevanje krvnih strdkov), ki se uporablja pri odraslih za preprečevanje in zdravljenje bolezni, povezanih s krvnimi strdki, kot je globoka venska tromboza (pri kateri se strdek razvije v globoki veni, običajno v nogi), ter nestabilne angine pektoris (hude bolečine v prsnem košu, ki je posledica oviranega pritoka krvi v srce) in nekaterih vrst miokardnega infarkta (srčne kapi).
• 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; 
• preprečevanje venske trombembolije (krvnih strdkov, ki nastanejo v venah in ovirajo pretok krvi), zlasti pri bolnikih, pri katerih bo opravljen kirurški poseg ali ki jih strdki bolj ogrožajo, ker imajo zaradi bolezni zmanjšano mobilnost;
Lovenox contains the active substance enoxaparin. 
Zdravilo Lovenox vsebuje zdravilno učinkovino enoksaparin.
On 12 November 2015, France referred the matter to the CHMP in order to harmonise the marketing authorisations for Lovenox in the EU. 
Da bi uskladili dovoljenja za promet z zdravilom Lovenox v EU, je Francija 12. novembra 2015 napotila zadevo na odbor CHMP.
• to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart); 
• zdravljenje nestabilne angine pektoris (hude bolečine v prsnem košu, ki je posledica oviranega pritoka krvi v srce);
• 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); 
• zdravljenje bolezni, povezanih s krvnimi strdki, kot sta globoka venska tromboza (pri kateri se strdek razvije v globoki veni, običajno v nogi) ali pljučna embolija (strdek v žili, ki oskrbuje pljuča);
Lovenox was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). 
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Lovenox potrebno usklajevanje.
All risks should be captured in the risk management plan. 
Vsa tveganja je treba zajeti v načrtu za obvladovanje tveganj.
Sufficient evidence of efficacy in this patient population is available. 
O učinkovitosti pri tej skupini bolnikov obstaja dovolj dokazov.
In this regard, a study on the profile of aprotinin use is needed, particularly in light of the importance of adequate anticoagulation. 
V zvezi s tem je treba izvesti študijo o profilu uporabe aprotinina, zlasti glede na pomembnost zadostne antikoagulacije.
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). 
Aprotinin se sme uporabljati samo po skrbnem pretehtanju koristi in tveganj ter ob upoštevanju, da so na voljo tudi druga zdravila (glejte poglavji 4.4 in 5.1).
In addition, results from observational studies are conflicting. 
Poleg tega so si rezultati opazovalnih študij nasprotujoči.
In the initial review in 2007 concerns had also been raised by the findings of three observational studies. 
Med začetnim pregledom leta 2007 so bili izraženi tudi pomisleki o ugotovitvah treh opazovalnih študij.
This document presents the conclusions on aprotinin. 
V tem dokumentu so predstavljeni sklepi o aprotininu.
In case of repeated treatment, physicians should be aware of the risk, and manage their patients adequately. 
V primeru ponovljenega zdravljenja se morajo zdravniki zavedati tveganja in bolnike ustrezno obravnavati.
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. 
Pogoji za varno in učinkovito uporabo zdravil, ki jih morajo upoštevati države članice, so navedeni v Prilogi IV tega mnenja.
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. 
Nič ne kaže na to, da bi se učinkovitost razlikovala glede na leta ali da bi bil varnostni profil aprotinina drugačen pri starejših bolnikih v primerjavi s celotno proučevano populacijo.
All risks of aprotinin known to date were considered. 
Obravnavana so bila vsa do sedaj znana tveganja, povezana z aprotininom.
The CHMP noted the uncertainties and advised that the interpretation of all available data from observational studies is limited. 
Odbor CHMP je upošteval negotovosti in sporočil, da je razlaganje vseh razpoložljivih podatkov iz opazovalnih študij omejeno.
The registry, which will be mandatory for use of the product, will monitor the pattern of use in participating countries and record utilisation information. 
Register, ki bo obvezen za uporabo zdravila, bo namenjen spremljanju vzorca uporabe v sodelujočih državah in beleženju informacij o uporabi.
The final results of BART study have since become available, together with important new analysis of the study data. 
Zdaj so na voljo končni rezultati študije BART, skupaj s pomembno novo analizo podatkov iz študije.
The quality review of documents templates were taken into account during this review. 
Med tem pregledom je bil upoštevan pregled kakovosti predlog za dokumente.
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. 
Poleg tega se lahko aprotinin uporablja samo pri odraslih bolnikih (podatki o uporabi pri otrocih niso na voljo), ki so v veliki nevarnosti za obsežno izgubo krvi.
Overall summary of the scientific evaluation of referral on antifibrinolytics Aprotinin containing medicinal products (see Annex I) 
Splošni povzetek znanstvenega vrednotenja napotitve za antifibrinolitike Zdravila, ki vsebujejo aprotinin (glejte Prilogo I)
Divergent positions are appended to the Opinion. 
Različna stališča so predstavljena v prilogi tega mnenja.
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. 
Pomembno je, da se to upošteva pri zdravljenju bolnikov z znano predobstoječo okvaro in bolnikov, ki se sočasno zdravijo z zdravili, ki lahko vplivajo na delovanje ledvic.
The MAHs will submit a revised protocol for the registry to national competent authorities. 
Imetniki dovoljenj za promet z zdravili bodo pristojnim nacionalnim organom predložili revidirani protokol za register.
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. 
Ponovna operacija zaradi krvavitev je povezana z visokim tveganjem za povečano obolevnost, kar je izpostavila tudi skupina zunanjih strokovnjakov, s katerimi se je posvetoval CHMP.
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. 
Odbor CHMP je menil, da morajo biti vsa ta tveganja, skupaj z negotovostmi o izsledkih kliničnih preskušanj in opazovalnih študij v zvezi s smrtnostjo, ustrezno predstavljena kot opozorila in priporočila v informacijah o zdravilu ter zajeta v načrtu za obvladovanje tveganja.
• The Committee considered that the product information should be updated to ensure that the information to healthcare professionals and patients is up-to-date. 
• odbor je menil, da je treba posodobiti informacije o zdravilih, da bi zdravstvenim delavcem in bolnikom zagotovili najnovejše informacije.
Other notable safety concerns include the identified risk for transient renal impairment, which is a well characterised unfavourable effect of treatment with aprotinin. 
Med drugimi pomembnimi pomisleki v zvezi z varnostjo je ugotovljeno tveganje za prehodno okvaro ledvic, ki je dobro opredeljen neželeni učinek zdravljenja z aprotininom.
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. 
Opravljen je bil natančen pregled in odbor CHMP je zaključil, da so končni rezultati študije BART zelo vprašljivi, saj je bilo na novo ugotovljenih več pomembnih metodoloških pomanjkljivosti, ki naj bi bile odločilnega pomena za veljavnost in razlaganje rezultatov.
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: 
je odbor CHMP zaključil, da je razmerje med tveganji in koristmi za aprotinin pozitivno pri običajnih pogojih uporabe in z naslednjo revizijo indikacije:
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. 
Odbor CHMP je menil, da na splošno predloženi podatki predstavljajo tveganja, povezana z neustreznim spremljanjem antikoagulacijskega učinka heparina, uporabljenega med postopkom CABG.
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. 
Na podlagi končnih rezultatov in novih dokazov iz ponovne analize podatkov, ki so po dokončanju študije BART razkrili pomanjkljivosti v študiji, odbor CHMP meni, da ti podatki niso zanesljivi in da jih ni mogoče upoštevati v zvezi s srčno-žilnimi tveganji pri uporabi aprotinina.
The marketing authorisations for aprotinin were suspended following the preliminary results of the BART study in 2007, and concerns raised over some observational studies. 
Dovoljenja za promet z aprotininom so bila leta 2007 po predhodnih rezultatih študije BART začasno umaknjena in izraženi so bili pomisleki glede nekaterih opazovalnih študij.
• The Committee concluded that evidence from randomised clinical trials and observational studies support the use of aprotinin in reducing the incidence of massive bleeding, the need for transfusion of blood products and the need for re-surgery for bleeding. 
• odbor je zaključil, da dokazi iz randomiziranih kliničnih preskušanj in opazovalnih študij podpirajo uporabo aprotinina za zmanjšanje pojavnosti obsežnih krvavitev, potrebe po transfuziji krvnih produktov in potrebe po ponovni operaciji zaradi krvavitve;
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. 
Poleg tega morajo imetniki dovoljenj za promet z zdravili, ki vsebujejo aprotinin, vpeljati register za zbiranje več informacij o profilu uporabe aprotinina.
The reduction of the need for resurgery after coronary artery bypass grafting (CABG) demonstrated for aprotinin is considered to be a benefit of high clinical relevance. 
Zmanjšanje potrebe po ponovni operaciji po vstavitvi obvoda koronarne arterije (CABG), ki je dokazano povezano z aprotininom, je korist, ki ima zelo velik klinični pomen.
Anaphylactic reactions are another well-known adverse effect that primarily occurs after repeated treatment. 
Drugi dobro znani neželeni učinek so anafilaktične reakcije, ki se pojavijo predvsem po ponovljenem zdravljenju.
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. 
Med pomanjkljivostmi so bile nepojasnjena izključitev bolnikov iz analize, izhodiščne razlike v osnovnih značilnostih med skupinami v študiji, ki kljub randomizaciji niso bile homogene, in navidezno znižana stopnja heparinizacije v kraku z aprotininom, ki bi povečala tveganje za trombogene dogodke v tej skupini.
Reduction in massive bleeding, transfusion need and risk for re-surgery due to bleeding are considered meaningful clinically important effects of aprotinin, and when considering the overall data on the known risks, the CHMP considered that the balance is clearly positive in the identified patient population. 
Zmanjšanje obsežnih krvavitev, potrebe po transfuziji in tveganja za ponovno operacijo zaradi krvavitev so bistveni klinično pomembni učinki aprotinina, zato je CHMP po pregledu vseh podatkov o znanih tveganjih menil, da je razmerje pri opredeljeni populaciji bolnikov zagotovo pozitivno.
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. 
Novi podatki, ki so trenutno na voljo, pa so pokazali, da bi bilo treba spremeniti indikacijo ter nekatera poglavja informacij o zdravilu, da bi se ustrezno upoštevala znana tveganja in negotovosti, povezane z njimi.
Special attention is also to be given to patients with renal impairment and to the possible occurrence anaphylactic reactions. 
Posebno pozornost je treba nameniti bolnikom z okvaro ledvic in morebitnemu pojavu anafilaktičnih reakcij.
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: 
Zato je Odbor pristal na ukinitev začasnega umika aprotinina, ker je menil, da je razmerje med tveganji in koristmi pozitivno za naslednjo revidirano indikacijo za aprotinin:
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. 
Zdaj so na voljo nove opazovalne študije in rezultati so pokazali, da aprotinin ni vplival na smrtnost v bolnišnici, medtem ko so v eni študiji ugotovili statistično pomembno „korist“ aprotinina v primerjavi s traneksamično kislino, kar zadeva smrtnost med bolniki z visokim tveganjem, ki so imeli operacijo srca.
• 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. 
• odbor CHMP je zaključil, da podatki iz študije BART in znaki povečane smrtnosti, povezane z aprotininom v primerjavi z aminokaprojsko in traneksamično kislino, ne štejejo za zanesljive, kar temelji na vseh dokazih, ki so na voljo zdaj, po pregledu aprotinina v letu 2007, vključno z novejšimi opazovalnimi študijami, novimi analizami podatkov iz študije BART in ugotovljenimi večjimi pomanjkljivostmi v študiji ter ob upoštevanju nasveta znanstvene svetovalne skupine (SAG).
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. 
Med drugim se bodo zbirale informacije o številu bolnikov, ki prejemajo aprotinin, indikacijah za uporabo, značilnostih bolnikov in dejavnikih tveganja ter pogojih uporabe, vključno s podatki o heparinizaciji bolnikov, zdravljenih z aprotininom.
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. 
Zato se ob upoštevanju vseh podatkov ocenjuje, da je predhodne znake povečane smrtnosti, povezane z uporabo aprotinina, mogoče ovreči ob predpostavki, da se aprotinin uporablja pri opredeljeni ciljni populaciji in da se upošteva priporočila za njegovo uporabo.
• The Committee considered all data provided by the MAHs in writing and at the oral explanation, including data available from literature reviews and the outcome of a scientific advisory group. 
• odbor je preučil vse podatke, ki so jih predložili imetniki dovoljenj za promet z zdravili pisno in z ustnimi obrazložitvami, vključno s podatki iz pregledov strokovne literature in z mnenjem znanstvene svetovalne skupine;
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. 
Z upoštevanjem vseh podatkov o učinkovitosti in varnosti aprotinina, ki so trenutno na voljo, je CHMP menil, da ni dvomov o populaciji bolnikov, pri katerih koristi sistemskega aprotinina jasno odtehtajo z njim povezana tveganja.
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. 
Rezultati ponovne analize dveh od teh študij niso pokazali statistično pomembne povezave med zdravljenjem z aprotininom in srčnim infarktom ter drugimi opazovanimi srčno-žilnimi dogodki; glede tretje opazovalne študije, v kateri dodatna analiza prav tako ni pokazala pomembne povezave med aprotininom in sedemdnevno smrtnostjo v bolnišnici, so se pojavili metodološki pomisleki.
On the basis of the above, the Committee recommended the lifting of the suspension and the amendment of the marketing authorisations for the medicinal products containing aprotinin referred to in Annex I for which the amendments to the product information are set out in annex III of the opinion. 
Na podlagi navedenega je Odbor priporočil ukinitev začasnega umika in spremembo dovoljenj za promet z zdravili, ki vsebujejo aprotinin, naštetimi v Prilogi I. Spremembe informacij o zdravilih so navedene v Prilogi III tega mnenja.
No firm conclusion on cardiovascular risks can be made on the BART study due to several serious methodological issues identified. 
Na podlagi študije BART ni trdnih zaključkov o tveganjih za srce in ožilje, ker so ugotovili več resnih metodoloških pomanjkljivosti.
Overall, the CHMP considered that the BART study was not designed to reliably determine the risk of death associated with aprotinin in relation to EACA or TXA and the results of higher mortality initially observed in aprotinin treated patients may be due to chance. 
V splošnem je odbor CHMP menil, da zasnova študije BART ni omogočila zanesljivih ugotovitev o tveganju za smrt, povezanem z aprotininom v primerjavi z aminokaprojsko ali traneksamično kislino, in da je večjo umrljivost, ki so jo najprej opazili pri bolnikih, zdravljenih z aprotininom, mogoče pripisati naključju.
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. 
Opravljena sta bila pregled informacij o zdravilih z namenom določitve soglasne ciljne populacije in posodobitve kliničnega dela informacij o zdravilih, da bi imeli zdravstveni delavci in bolniki v vseh državah članicah na voljo najnovejše informacije.
The product has been used outside its indication, with several trials where risks were observed conducted in a wider patient population. 
Zdravilo se je uporabljalo za neodobrene indikacije, pri čemer je bilo izvedenih več preskušanj pri širši populaciji, v katerih so opazili tveganja.
The observational studies have provided conflicting results related to mortality as discussed above. 
V opazovalnih študijah so si bili rezultati v zvezi z omenjeno smrtnostjo nasprotujoči.
The scientific conclusions and the grounds for the lifting of the suspension and amendment of the marketing authorisation are set out in annex II of the opinion. 
Znanstveni zaključki in razlogi za ukinitev začasnega umika in spremembo dovoljenj za promet z zdravili so navedeni v Prilogi II tega mnenja.
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. 
CHMP je menil, da je treba v besedilni opis indikacije vključiti pojasnilo, da se lahko zdravilo uporablja pri bolnikih, ki so prestali obvodno operacijo koronarne arterije med izoliranim kirurškim posegom za vstavitev obvoda koronarne arterije, ker učinkovitost in varnost aprotinina pri obsežnejših operacijah nista dovolj raziskani.
A direct healthcare professional communication (DHPC) was agreed to provide prescribers with information on the review and an update on the safety information for aprotinin. 
Vpeljana je bila neposredna komunikacija z zdravstvenimi delavci, da bi bili zdravniki, ki predpisujejo zdravila, seznanjeni z informacijami o pregledu in s posodobitvijo informacij o varnosti aprotinina.
The CHMP considered that the efficacy of aprotinin has been clearly demonstrated in prospective randomised trials and meta-analysis of clinical trials which show that aprotinin reduces the incidence of massive bleeding, reduces the need for transfusion of blood products and reduces the need for resurgery for bleeding in patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB). 
CHMP je menil, da je bila učinkovitost aprotinina jasno dokazana v prospektivnih randomiziranih preskušanjih in z metaanalizo kliničnih preskušanj, ki kaže, da aprotinin zmanjšuje pojavnost obsežnih krvavitev, zmanjšuje potrebo po transfuziji krvnih produktov in zmanjšuje potrebo po ponovni operaciji zaradi krvavitve pri bolnikih, ki imajo operacijo srca z vstavitvijo obvoda koronarne arterije.