natgillin/translations-raw huggingface dataset:
Andexanet alfa is administered as an intravenous bolus at a target rate of approximately 30 mg/min over 15 minutes (low dose) or 30 minutes (high dose), followed by administration of a continuous infusion of 4 mg/min (low dose) or 8 mg/min (high dose) for 120 minutes (see table 1). 
Andeksanet alfa primjenjuje se kao intravenski bolus ciljnom brzinom od otprilike 30 mg/min tijekom 15 minuta (niska doza) ili 30 minuta (visoka doza) nakon kojeg slijedi kontinuirana infuzija od 4 mg/min (niska doza) ili 8 mg/min (visoka doza) tijekom 120 minuta (vidjeti tablicu 1).
How Ondexxya is stored 
Kako čuvati Ondexxyu
Peripheral coldness common 
Hladne okrajine često
No trials have been conducted to investigate the pharmacokinetics of andexanet alfa in patients with hepatic impairment. 
Nisu provedena ispitivanja farmakokinetike andeksaneta alfa u bolesnika s oštećenom funkcijom bubrega.
Cerebrovascular accident uncommon 
Cerebrovaskularni incident manje često
Once all required vials are reconstituted, the reconstituted solution is withdrawn from each vial, using the large volume (60 mL or larger) syringe equipped with a 20 gauge (or larger) needle. 
Nakon što je rekonstituiran potreban broj bočica, otopina rekonstituiranog lijeka navlači se iz svake bočice pomoću štrcaljke velikog volumena (60 ml ili veće) s iglom od 20 G (ili većom).
Andexanet alfa is administered as an intravenous (IV) bolus at a target rate of approximately 30 mg/min over 15 (low dose) or 30 minutes (high dose), immediately followed by administration of a continuous infusion of 4 mg (low dose) or 8 mg (high dose) per minute for 120 minutes (see table 1). 
Andeksanet alfa se primjenjuje kao intravenski (i.v.) bolus brzinom od otprilike 30 mg/min tijekom 15 (niska doza) ili 30 minuta (visoka doza), nakon čega odmah slijedi kontinuirana infuzija od 4 mg (niska doza) ili 8 mg (visoka doza) u minuti tijekom 120 minuta (vidjeti tablicu 1).
Acute myocardial infarction uncommon 
Srčani poremećaji Akutni infarkt miokarda manje često
Administration using a syringe pump 
Primjena pomoću perfuzora (infuzijske pumpe sa štrcaljkom)
Each vial contains 200 mg of andexanet alfa*. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 200 mg andeksaneta alfa*.
High dose 
nepoznato visoka doza
Mannitol 
Intravenski
Abdominal pain common 
Bol u abdomenu često
Each vial contains 200 mg of andexanet alfa. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 200 mg andeksaneta alfa.
Myocardial infarction uncommon 
Infarkt miokarda manje često
The recommended dose regimen of Ondexxya is based on the dose of rivaroxaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of rivaroxaban (see table 3). 
Preporučeni režim doziranja Ondexxye temelji se na dozi rivaroksabana koju bolesnik uzima u trenutku potrebe reverzije antikoagulacije, kao i o vremenu proteklom od zadnje doze rivaroksabana koju je bolesnik primio (vidjeti tablicu 3).
The reconstituted solution should be inspected for particulate matter and/or discolouration prior to administration. 
7. Prije primjene potrebno je provjeriti ima li u rekonstituiranoj otopini vidljivih čestica i/ili promjene boje.
Hepatic impairment 
Završetak bolusa
Pulmonary embolism uncommon 
Plućna embolija manje često
• If you get any side effects, talk to your doctor or nurse. 
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
The recommended dose regimen of andexanet alfa is based on the dose of rivaroxaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of rivaroxaban (see table 3). 
Preporučeni režim doziranja andeksaneta alfa temelji se na dozi rivaroksabana koju bolesnik uzima u trenutku potrebe reverzije antikoagulacije, kao i o vremenu proteklom od zadnje doze rivaroksabana koju je bolesnik primio (vidjeti tablicu 3).
Reversing FXa inhibitor therapy exposes patients to the thrombotic risk of their underlying disease. 
FXa ti se bolesnici izlažu riziku od tromboze uzrokovane osnovnom bolešću.
Powder for solution for infusion 4 x 1 vial of 200 mg 
4 x1 bočica od 200 mg
The recommended dose regimen of Ondexxya is based on the dose of apixaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of apixaban (see table 2). 
Preporučeni režim doziranja Ondexxye temelji se na dozi apiksabana koju bolesnik uzima u trenutku potrebe reverzije antikoagulacije, kao i o vremenu proteklom od zadnje doze apiksabana koju je bolesnik primio (vidjeti tablicu 2).
Submission of the final CSR by 30 
Podnošenje konačnog izvješća o kliničkom ispitivanju do 30. rujna
The occurrence of thromboembolic events was generally comparable between patients > 75 years (11.0%; 24/219) and those ≤ 75 years of age (9.1%; 12/132). 
> 75 godina (11,0%: 24/219) i onih u dobi
Pruritus generalised common 
Generalizirani svrbež često
PK/PD modelling 
Farmakokinetičko/farmakodinamičko modeliranje
The recommended dose regimen of andexanet alfa is based on the dose of apixaban the patient is taking at the time of anticoagulation reversal, as well as on the time since the patient's last dose of apixaban (see table 2). 
Preporučeni režim doziranja andeksaneta alfa temelji se na dozi apiksabana koju bolesnik uzima u trenutku potrebe reverzije antikoagulacije, kao i na vremenu proteklom od zadnje doze apiksabana koju je bolesnik primio (vidjeti tablicu 2).
Reporting suspected adverse reactions after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. 
Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.
Deep vein thrombosis uncommon 
Krvožilni poremećaji Duboka venska tromboza manje često
Tris hydrochloride L-arginine hydrochloride Sucrose 
6.1 Popis pomoćnih tvari tris baza tris hidroklorid L-arginin hidroklorid saharoza manitol polisorbat 80 6.2 Inkompatibilnosti
Administration using a syringe pump 1. 
Prašak za otopinu za infuziju.
Iliac artery occlusion uncommon 
Okluzija ilijačne arterije manje često
• itching 
(engl.
METHOD AND ROUTE(S) OF ADMINISTRATION 
Anti-FXa (ng/ml)
Based on data from 352 patients from the Phase IIIb/IV ANNEXA-4 study treated with an FXa inhibitor and experiencing an acute major bleeding episode, one patient experienced a serious or severe infusion-related reaction. 
Na temelju podataka prikupljenih na 352 bolesnika u fazi IIIb/IV ispitivanja ANNEXA-4 liječenih inhibitorom
• nausea (feeling sick) 
Vrijeme nakon bolusa (sati)
Ischaemic stroke common 
Ishemijski moždani udar često
Cerebral infarction uncommon 
Promjena koncentracije nevezanog inhibitora
Musculoskeletal and connective tissue disorders 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Bol u leđima često
Remove the flip-top from each vial. 
Skinite poklopac s bočice.
Nausea common 
Mučnina često
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION 
• Uvjetno odobrenje za stavljanje lijeka u promet
Deaths 
Dojenje
Name and address of the manufacturer of the biological active substance Lonza Biologics Porrino, S.L. 
Naziv i adresa proizvođača biološke djelatne tvari
(2) Produced in human diploid lung (WI-38) fibroblasts. 
(2) Umnožen na ljudskim diploidnim plućnim (WI-38) fibroblastima.
(1) Produced in chick embryo cells. 
(1) Umnožen na stanicama pilećeg embrija.
(3) Produced in human diploid (MRC-5) cells. 
(3) Umnožen na ljudskim diploidnim (MRC-5) stanicama.
*50% cell culture infectious dose **plaque-forming units 
*količina virusa kojom se zarazi 50% kulture stanica (50% cell culture infectious dose) **jedinice stvaranja plakova
Mumps virus1 Jeryl Lynn™ (Level B) strain (live, attenuated) not less than 4.30 log10 CCID50* Rubella virus2 Wistar RA 27/3 strain (live, attenuated) 
§ živi, atenuirani virus morbila1, soj Enders' Edmonston ne manje od 3,00 log10 CCID50* živi, atenuirani virus parotitisa1, soj Jeryl Lynn™ [Razina B] ne manje od 4,30 log10 CCID50* živi, atenuirani virus rubele2, soj Wistar RA 27/3 ne manje od 3,00 log10 CCID50* živi, atenuirani virus varičele3, soj Oka/Merck ne manje od 3,99 log10 PFU**
10 vials + 10 pre-filled syringes with attached needle 
10 bočica + 10 napunjenih štrcaljki sa spojenom iglom
1 vial + 1 pre-filled syringe with attached needle 
1 bočica + 1 napunjena štrcaljka sa spojenom iglom
In such case, treatment must be stopped immediately. 
U ovakvom se slučaju liječenje mora odmah prekinuti.
The timetable for the implementation of the agreement is set out in Annex V. 
Raspored provedbe sporazuma naveden je u Dodatku V.
The PRAC noted that others studies will become available. 
PRAC je napomenuo da će druga ispitivanja postati dostupna.
The studies and their limitations were considered together with the overall evidence available to date. 
Ispitivanja i njihova ograničenja razmotrena su zajedno s cjelokupnim trenutno dostupnim dokazima.
• The PRAC noted that some of the studies have methodological limitations. 
• je PRAC napomenuo da pojedina ispitivanja imaju metodološka ograničenja.
Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation. 
Nakon što je pregledao preporuku PRAC-a, CMDh je suglasan s cjelokupnim znanstvenim zaključcima i razlozima za preporuku.
• The PRAC considered the procedure under Article 31 of directive 2001/83/EC for testosteronecontaining medicinal products. 
• je PRAC razmotrio postupak u skladu s člankom 31. Direktive 2001/83/EC za lijekove koji sadrže testosteron.
In addition, there is limited experience on the safety and efficacy of the use of testosterone in patients over 65 years of age. 
Nadalje, postoji ograničeno iskustvo o sigurnosti i djelotvornosti primjene testosterona u bolesnika starijih od 65 godina.
The next PSUR, will have the common DLP to all testosterone-containing medicinal products of 31 December 2015. 
Sljedeći PSUR imat će zajednički DLP za sve lijekove koji sadrže testosteron od dana 31. prosinca
Some studies show an increased risk while others do not suggest a risk and therefore have not corroborated the signal. 
Pojedina ispitivanja ukazuju na povišeni rizik dok druga ne ukazuju na rizik, te stoga ne potvrđuju signal.
The clinical symptoms depend on the age of onset androgen deficiency. 
Klinički simptomi ovise o dobi nastupanja androgenog deficita.
On the other hand, testosterone stimulates red blood proliferation, which theoretically could increase the risk of thromboembolic events. 
S druge strane, testosteron stimulira prolifiraciju crvenih krvnih stanica, što može u teoriji povećati rizik od tromboembolijskih događaja.
Also, the RHYME study, an observational registry study performed in 6 European countries evaluating the association between TT (over two years) and prostate health outcome in men with hypogonadism also looked at health outcomes, as secondary endpoints. 
Također, ispitivanje RHYME, opservacijsko ispitivanje registra provedeno u 6 europskih država ocijenilo je poveznicu između TT-a (tijekom dvije godine) i zdravstvene rezultate za prostatu u muškaraca s hipogonadizmom, te je također istražilo zdravstvene rezultate, kao sekundarne završne točke.
The CMDh considered the below PRAC recommendation with regard to testosterone containing medicinal products: 
CMDh je razmotrio niže navedenu preporuku PRAC-a u vezi s lijekovima koji sadrže testosteron:
There are no treatment alternatives to testosterone for male hypogonadism (Buvat et al. 20132) 
Ne postoje alternative liječenju testosteronom za muški hipogonadizam (Buvat et al., 2013.2)
Also, that there is limited data regarding elderly patients above the age of 65 and this will also be reflected in the warning section of the product information of all testosterone-containing medicinal products. 
Također, postoje ograničeni podaci u vezi sa starijim bolesnicima u dobi iznad 65 godina te će isto biti navedeno u dijelu upozorenja informacija o lijeku za sve lijekove koji sadrže testosteron.
However, the CMDh considered that an amendment was required in the package leaflet to improve clarity for patients that should tell their doctor if they have high blood pressure but also if they are being treated for high blood pressure. 
No, CMDh je zaključio da je potrebna izmjena upute o lijeku kako bi se poboljšalo pojašnjenje za bolesnike koji trebaju obavijestiti svoje liječnike ako imaju viski krvni tlak, te ako su liječeni od visokog krvnog tlaka.
As an example, recently published studies (Baillargeon et al., 20146; Corona et al., 20147; Tan et al., 20148; Hildreth et al., 20139), with the objective to examine the risk of cardiovascular events with TT, did not report an increase in this risk. 
Na primjer, u nedavno objavljenim ispitivanjima (Baillargeon et al., 2014.6; Corona et al., 2014.7; Tan et al., 2014.8; Hildreth et al., 2013.9), čiji je cilj bio ispitivanje rizika kardiovaskularnih događaja pri primjeni TT-a, nije zabilježeno povećanje tog rizika.
Further studies will be needed to provide relevant safety and efficacy data in this patient population. 
Bit će potrebna daljnja ispitivanja kako bi se dostavili relevantni podaci o sigurnoj primjeni i djelotvornosti u ovoj populaciji bolesnika.
Information on the cardiovascular safety and well-documented blood system adverse reactions, which may contribute to the cardiovascular risk should be included in the product information. 
Informacije o kardiovaskularnoj sigurnosti i dobro dokumentirane nuspojave krvožilnog sustava koje mogu doprinijeti kardiovaskularnom riziku treba navesti u informaciji o lijeku.
Testosterone is an androgenic hormone secreted by the Leydig cells in the testis. 
Testosteron je androgeni hormon koji luče Leydigove stanice u testisima.
• The PRAC also concluded that there was the need for all MAHs to closely monitor cardiovascular risk and discuss the findings including venous thromboembolic events and possible mechanism(s) and usage pattern and adverse events in patients older than 65 years in the next PSUR. 
• je PRAC također zaključio da postoji potreba za sve nositelje odobrenja da pažljivo prate kardiovaskularni rizik i rasprave rezultate, uključujući venske tromboembolijske događaje i mogući(e) mehanizam(e) i obrasce primjene i nuspojave u bolesnika starijih od 65 godina u sljedećem PSUR-u.
If the hypogonadism develops before puberty e.g. as part of a genetic disease, the men will exhibit eunuchoid proportions, delayed of secondary sex characterises and high pitched voice. 
Ako se hipogonadizam razvije prije puberteta, primjerice kao dio genetske bolesti, u muškaraca će se manifestirati eunuhoidne proporcije, odgođene sekundarne seksualne karakteristike i glas visoke frekvencije.
The PRAC also recognised that testosterone may have both direct and indirect effect on the cardiovascular systems: low testosterone increases the risk of the metabolic syndrome, which could potentially increase the risk of adverse cardiovascular events. 
PRAC je također priznao da testosteron može imati izravno i neizravno djelovanje na kardiovaskularni sustav: niska razina testosterona povećava rizik od metaboličkog sindroma, koji može potencijalno povećati rizik od kardiovaskularnih nuspojava.
It is known that in patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. 
Poznato je da u bolesnika koji pate od ozbiljne srčane, jetrene ili bubrežne insuficijencije ili ishemijske bolesti srca liječenje testosteronom može uzrokovati ozbiljne komplikacije karakterizirane edemom s ili bez kongestivnog zatajenja srca.
Concerns were raised with regards to a potential increased risk of cardiovascular events, namely myocardial infarction, in men treated with testosterone and who have pre-existing heart disease (Finkle et al, 20143; Vigen et al, 20134 and Xu et al, 20135). 
Izražena je zabrinutost u vezi s mogućim povećanim rizikom od kardiovaskularnih događaja, posebice infarkta miokarda, u muškaraca liječenih testosteronom i onih koji su imali već postojeću srčanu bolest (Finkle et al, 2014.3; Vigen et al, 2013.4 i Xu et al, 2013.5).
Therefore, taking the totality of data into account it is judged that the signal for an increased cardiovascular risk associated with the use of testosterone remains weak and inconclusive. 
Stoga, uzimajući u obzir ukupnost podataka, ocijenjeno je kako signal za povišeni kardiovaskularni rizik povezan s uporabom testosterona ostaje slab i nepotpun.
3 Finkle et al. “Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” PLoS One. 
“Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men.” PLoS One.
Based on all the above discussed, the PRAC considered justified to reflect in the product information of all testosterone containing medicinal products approved in the European Union that prescribing testosterone for hypogonadism should be based upon confirmation of both clinical features and biochemical testing. 
Na temelju prethodno raspravljenog, PRAC je razmotrio je li opravdano u informacijama o lijeku za sve u Europskoj uniji odobrene lijekove koji sadrže testosteron navesti napomenu da se propisivanje testosterona za hipogonadizam treba temeljiti na potvrdi kako kliničkih značajki, tako i biokemijskog testiranja.
Testosterone should be used with caution in men with hypertension and testosterone levels should be monitored both at baseline and at regular intervals during treatment to ensure the adequacy of the dose administered. 
Testosteron treba oprezno koristiti u muškaraca s hipertenzijom, a koncentracije testosterona treba pratiti u osnovnoj vrijednosti i u redovitim intervalima tijekom liječenja kako bi se osigurala primjerenost primijenjene doze.
The wording was amended accordingly in section 2 of the Package Leaflet as set out in Annex III. 
Tekst je izmijenjen u skladu s dijelom 2. upute o lijeku kako je navedeno u Dodatku III.
Hypogonadism in men is a congenital or acquired syndrome, in which the testis fails to produce physiological levels of testosterone and spermatozoa, as there is a disruption in the hypothalamicpituitary-testicular axis (HPT). 
Hipogonadizam u muškaraca je nasljedni ili stečeni sindrom, pri kojem testisi ne proizvode fiziološke razine testosterona i spermija jer postoji prekid u osi hipotalamus-hipofiza-testisi (HPT).
• The Committee considered the studies that heightened concerns about the increased risk of cardiovascular events associated with testosterone therapy and available data submitted from clinical trials, observational studies, meta-analyses, post-marketing data and further published data. 
• je Odbor razmotrio ispitivanja koja su povećala zabrinutost povezanu s povišenim rizikom od kardiovaskularnih događaja povezanih s terapijom testosteronom i podatke dostupne iz kliničkih ispitivanja, opservacijskih ispitivanja, meta analiza, podatke nakon stavljanja lijeka u promet i daljnje objavljene podatke.
Testosterone, as well as other androgens and anabolic steroids, should be used cautiously in patients with cardiovascular disorders, renal or hepatic impairment, epilepsy, migraine, diabetes mellitus or other conditions that may be aggravated by the possible fluid retention or oedema caused. 
Testosteron, kao i drugi androgeni i anabolički steroidi, treba oprezno primjenjivati u bolesnika s kardiovaskularnim poremećajima, oštećenjem funkcije bubrega ili jetre, epilepsijom, migrenom, dijabetes melitusom ili drugim stanjima koja mogu biti pogoršana mogućim zadržavanjem tekućine ili edemom koji su uzrokovani terapijom.
The CMDh, having considered the PRAC recommendation dated 9 October 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the variation of the marketing authorisations of testosterone containing medicinal products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV. 
Nakon što je razmotrio preporuku PRAC-a od 9. listopada 2014. u skladu s člankom 107.k stavcima 1. i 2. Direktive 2001/83/EZ, CMDh je suglasan s izmjenom uvjeta odobrenja za stavljanje u promet lijekova koji sadrže testosteron, za koje su relevatni dijelovi sažetka opisa svojstava i upute o lijeku navedeni u Dodatku III. i podložni su uvjetima navedenim u Dodatku IV.
It is an essential hormone for the development of male reproductive tissues as the testis and the prostate and in promoting secondary sexual characteristics such as increased muscle, bone mass, and the growth of body hair (Dollery et al., 19911). 
Taj je hormon neophodan za razvoj muškog reproduktivnog tkiva poput testisa i prostate, te u promoviranju sekundarnih seksualnih karakteristika poput povećanih mišića, koštane mase i rasta tjelesnih dlaka (Dollery et al., 1991.1).
The Committee recognised the limited available information on testosterone therapy for age-related hypogonadism and also the lack of reference. 
Odbor je priznalo ograničene dostupne informacije u vezi s terapijom testosterona za hipogonadizam povezan s dobi, kao i manjak referenci.
• The PRAC concluded that based on the overall currently available data, the suggested risk for cardiovascular events associated with the testosterone therapy remains a weak signal. 
• je PRAC zaključio da na temelju cjelokupnih trenutno dostupnih podataka, navedeni rizik od kardiovaskularnih događaja povezanih s terapijom testosteronom ostaje slabi signal.
• The Committee agreed, that it is justified to reflect in the product information of all testosterone-containing medicinal products the current knowledge on cardiovascular risks associated with testosterone therapy and recommended changes in section 4.1 (therapeutic indications), section 4.4 (warnings and precautions for use) and section 4.8 (undesirable effects) of the Summary of Product Characteristics. 
• je Odbor suglasan kako je u informaciji o lijeku za sve lijekove koji sadrže testosteron potrebno navesti aktualna saznanja o kardiovaskularnim rizicima povezanim s terapijom testosteronom i preporučio je izmjene u dijelu 4.1. (terapijske indikacije), dijelu 4.4. (upozorenja i mjere opreza) i dijelu 4.8. (nuspojave) sažetka opisa svojstava lijeka.
It is expected that the marketing authorisation holders continue to monitor cardiovascular events and it is expected that findings of ongoing studies will be reflected in periodic updated safety reports (PSURs) when available. 
Očekuje se da će nositelji odobrenja za stavljanje lijeka u promet nastaviti pratiti kardiovaskularne događaje kao i da će nalazi ispitivanja u tijeku biti prikazani u periodičkim izvješćima o neškodljivosti lijeka (PSUR-ovima) nakon što postanu dostupni.
4 Vigen et al. “Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.” JAMA. 
“Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.”
Overall the PRAC concluded that the findings in the literature do not consistently show an increased risk of cardiovascular events and do not corroborate the signal of an increased risk of cardiovascular events associated with testosterone therapy. 
Općenito, PRAC je zaključio da nalazi u literaturi ne potvrđuju konzistentno povećanje rizika kardiovaskularnih događaja i ne potvrđuju signal povišenog rizika od kardiovaskularnih događaja povezan s terapijom testosteronom.
The marketing authorisation holders are requested to investigate and report in the next PSUR on the usage of these products in this patient population and to consider if the pattern of adverse events is comparable to other age groups. 
Od nositelja odobrenja za stavljanje lijeka u promet zatraženo je da pri sljedećem PSUR-u istraži i prijavi primjenu tih lijekova u navedenoj populaciji bolesnika, te da razmotri je li uzorak nuspojava usporediv s drugim dobnim skupinama.