FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to optimise the uptake by HCPs and their adherence to the adequate conditions of use of HES solutions for infusion, the learned societies should be involved in the development and distribution of such training materials.
Croatian: Kako bi zdravstveni radnici u što većoj mjeri usvojili materijale i kako bi se poboljšalo njihovo poštovanje prikladnih uvjeta primjene otopina za infuziju koje sadrže HES, u izradi i podjeli takvih materijala trebaju sudjelovati znanstvene udruge.
English: The PRAC also contraindicated the use of HES solutions for infusion in patients with sepsis or who are critically ill.
Croatian: PRAC je također zaključio da je primjena otopina za infuziju koje sadrže HES kontraindicirana u bolesnika sa sepsom ili u bolesnika u kritičnom stanju.
English: Therefore the CMDh recommends the variation to the terms of the marketing authorisations for HES solutions for infusion.
Croatian: CMDh stoga preporučuje izmjene uvjeta za izdavanje odobrenja za stavljanje u promet otopina za infuziju koje sadrže HES.
English: In view of the above, the PRAC concluded that pursuant to Article 116 of Directive 2001/83/EC the risks related to the use of HES outweigh their benefits and thus the benefit-risk balance of HES solutions for infusion is no longer favourable.
Croatian: Direktive 2001/83/EZ, koristi lijekova koji sadrže HES ne nadmašuju rizike povezane s njihovom primjenom te stoga omjer koristi i rizika otopina za infuziju koje sadrže HES više nije povoljan.
English: The conduct of this study will be a condition to the marketing authorisations for HES solutions for infusion.
Croatian: Provođenje ovog ispitivanja bit će preduvjet za izdavanje odobrenja za stavljanje otopina za infuziju koje sadrže HES u promet.
English: "Guideline on the Readability of the labelling and package leaflet on medicinal products for human use", to be submitted within 1 month from the Commission Decision.
Croatian: Upozorenje i njegove vizualne pojedinosti trebali bi podlijegati ispitivanju korisnika u skladu sa „Smjernicom o čitljivosti označivanja i upute o lijeku za lijekove za humanu primjenu”, koju valja podnijeti u roku od mjesec dana od Odluke Komisije.
English: There is a direct relation between the degree of hypovolemia and the risk for renal injury and death.
Croatian: Stupanj hipovolemije i rizik od oštećenja bubrega i smrti izravno su povezani.
English: In order to prompt the attention of the recipients of the product information on the clinical situations above described, a warning to not use HES solutions for infusion in septic, renal impaired and critically ill patients should be mentioned at the top of the SmPC and PL.
Croatian: Radi privlačenja pozornosti primatelja informacija o lijeku o prethodno opisanim kliničkim situacijama, na vrhu sažetka opisa svojstava lijeka i upute o lijeku valja navesti upozorenje o tome da se otopine za infuziju koje sadrže HES ne smiju primjenjivati u bolesnika sa sepsom, oštećenjem bubrega i kritičnih bolesnika.
English: In 2012 and 2013, PRAC reviewed the benefits and risks of HES solutions for infusion in the treatment and prophylaxis of hypovolaemia, within Article 311 and 107i2 referral procedures.
Croatian: U okviru postupka upućivanja u skladu s člancima 31.1 i 107.i2 PRAC je 2012. i 2013. pregledao omjer koristi i rizika primjene otopina za infuziju koje sadrže HES za liječenje i profilaksu hipovolemije.
English: A positive benefit-risk balance has been established in elective surgery and trauma patients.
Croatian: Pozitivan omjer koristi i rizika utvrđen je za primjenu tih lijekova u neobaveznoj kirurgiji i u bolesnika s traumom.
English: However, the available evidence shows that the non-adherence is not only due to a lack of awareness of the restrictions by prescribers but also due in some cases to deliberate choice, rendering further communication and education unlikely to be sufficiently effective to address the risks identified.
Croatian: Međutim, dostupni dokazi pokazuju da se propisivači ne pridržavaju ograničenja ne samo zato što nisu s njima upoznati nego, u nekim slučajevima, i namjerno, zbog čega dodatna komunikacija i edukacija vjerojatno ne bi bile dostatno učinkovite za suzbijanje utvrđenih rizika.
English: However, the available evidence shows that the non-adherence is not only due to a lack of awareness of the restrictions by prescribers, rendering further communication and education unlikely to be sufficiently effective.
Croatian: Međutim, dostupni dokazi pokazuju da se propisivači lijekova ne pridržavaju ograničenja ne samo zato što nisu s njima upoznati, zbog čega dodatna komunikacija i edukacija vjerojatno ne bi bile dostatno učinkovite.
English: PRAC also recommended a drug utilisation study to evaluate the effectiveness of these risk minimisation measures.
Croatian: PRAC je također preporučio ispitivanje potrošnje lijeka radi ocjenjivanja učinkovitosti tih mjera.
English: The PRAC considered other further risk minimisation measures to sufficiently minimise this exposure, including changes to the product information, direct health care professional communication, educational materials, warning on the primary container of the products, sign-in for medication form, prescription sheet/checklists.
Croatian: Kako bi se ta izloženost dostatno smanjila, PRAC je razmotrio druge dodatne mjere minimizacije rizika, uključujući izmjene informacija o lijeku, izravnu obavijest zdravstvenim radnicima, edukacijske materijale, upozorenje na primarnom spremniku lijekova, obrazac za prijavu primjene lijeka, recepte / kontrolne popise.
English: However, the available evidence shows that the non-adherence is not only due to a lack of awareness of the restrictions by prescribers but also due to deliberate choice, rendering further communication and education unlikely to be sufficiently effective to address the risks identified.
Croatian: Međutim, dostupni dokazi pokazuju da se propisivači lijekova ne pridržavaju ograničenja ne samo zato što nisu s njima upoznati nego i namjerno, zbog čega dodatna komunikacija i edukacija vjerojatno ne bi bile dostatno učinkovite za suzbijanje utvrđenih rizika.
English: Due to the serious public health impact, Sweden was considering suspending the marketing authorisations for the above mentioned medicinal products, and therefore requested an urgent review of the matter at the European level, and asked the PRAC to assess the impact of the above concerns on the benefit-risk balance of HES solutions for infusion and issue a recommendation on whether the marketing authorisations of these products should be maintained, varied, suspended or revoked.
Croatian: Stoga je podnijela zahtjev za hitan pregled tog pitanja na europskoj razini te je zatražila od PRAC-a procjenu utjecaja navedenih zabrinjavajućih podataka na omjer koristi i rizika otopina za infuziju koje sadrže HES i izdavanje preporuke o tome treba li jedno ili više odobrenja za stavljanje u promet zadržati, izmijeniti, obustaviti ili opozvati.
English: Grounds for differences with the PRAC recommendation
Croatian: Razlozi za odstupanja od preporuke PRAC-a
English: Therefore, the CMDh is of the position that each MAH shall be responsible for the implementation and the supervision of the access controlled program as follows: - The MAH should develop the training materials for relevant HCPs expected to prescribe / administer HES solutions for infusion and agree the exact content and format of these materials with the relevant national competent authorities.
Croatian: - Nositelj odobrenja za stavljanje lijeka u promet treba izraditi materijale za osposobljavanje za relevantne zdravstvene radnike za koje se očekuje da će propisivati/primjenjivati otopine za infuziju koje sadrže HES i u pogledu točnog sadržaja i formata tih materijala treba postići dogovor s relevantnim nacionalnim nadležnim tijelima.
English: A more pronounced hypovolemia requires a greater volume (dose) of HES solutions for infusion and is also associated with a greater risk for renal injury and death.
Croatian: U slučaju hipovolemije jačeg intenziteta, povezane s većim rizikom od oštećenja bubrega i smrti, potreban je veći volumen (doza) otopina za infuziju koje sadrže HES.
English: The safety concerns of primary importance in this referral are increased mortality and a higher incidence of renal failure - the opposite of the benefit expected.
Croatian: Suprotno očekivanoj koristi, razlozi za zabrinutost od primarne važnosti u ovom postupku upućivanja jesu povećana smrtnost i veća učestalost zatajenja bubrega.
English: Med 2008; 358(2):125-39 5 Myburgh J, Finder S, Bellomo R et al. Hydroxyethyl starch or saline for fluid resuscitation in intensive care.
Croatian: 5 Myburgh J, Finder S, Bellomo R et al.
English: • Impact on the clinical practice of potential suspension of MA for HES solutions for infusion
Croatian: • Učinak obustave odobrenja za stavljanje u promet otopina za infuziju koje sadrže HES na kliničku praksu
English: Revision of PRAC recommendation
Croatian: Preispitivanje preporuke PRAC-a
English: FLASH study) would further characterise the efficacy and safety profile in elective surgery and trauma patients.
Croatian: Ovim ispitivanjima, kao i dobrovoljnim kliničkim ispitivanjima koja se trenutačno provode (npr. ispitivanje FLASH), dodatno bi se odredila učinkovitost i sigurnost u neobaveznoj kirurgiji i u bolesnika s traumom.
English: The medication form/checklists would also raise feasibility issues in an emergency setting.
Croatian: Također je upitna izvedivost uporabe obrazaca za prijavu primjene lijeka i kontrolnih popisa u hitnim situacijama.
English: A medication form to be filled before administration would also raise feasibility issues in an emergency setting.
Croatian: Također je upitna izvedivost uporabe obrazaca za prijavu primjene lijeka koje treba ispuniti prije primjene lijeka u hitnim situacijama.
English: Whereas
Croatian: Ti podatci
English: EU (MA) Number Invented name
Croatian: EU broj odobrenja Izmišljeno ime
English: Packaging Package size
Croatian: Put primjene Pakovanje Sastav Veličina pakovanja
English: Just take the next dose at the usual time.
Croatian: Samo uzmite sljedeću dozu u uobičajeno vrijeme.
English: telmisartan, irbesartan).
Croatian: telmisartana, irbesartana).
English: - are more than 3 months pregnant.
Croatian: - trudni više od 3 mjeseca.
English: It is important to keep taking Edarbi every day at the same time.
Croatian: Važno je da neprekidno uzimate Edarbi svaki dan u isto vrijeme.
English: Therefore, this medicine should not be given to children or adolescents.
Croatian: Stoga se ovaj lijek ne smije davati djeci ili adolescentima.
English: You can take this medicine with or without food.
Croatian: Ovaj lijek možete uzimati s hranom ili bez nje.
English: Take the tablet with plenty of water.
Croatian: Progutajte tabletu s puno vode.
English: Elderly (65 years and over)
Croatian: Starije osobe (u dobi od 65 ili više godina)
English: (It is also better to avoid this medicine in early pregnancy - see pregnancy section).
Croatian: (Bolje je izbjegavati ovaj lijek i u ranoj trudnoći - vidjeti dio o trudnoći).
English: Other possible side effects include:
Croatian: Ostale moguće nuspojave uključuju:
English: See also information under the heading “Do not take Edarbi”.
Croatian: Vidjeti također informacije pod naslovom “Nemojte uzimati Edarbi”
English: Additional information
Croatian: Dodatne informacije
English: The volume of distribution of azilsartan is approximately 16 litres.
Croatian: Volumen distribucije azilsartana iznosi približno 16 litara.
English: These are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), including isolated reports.
Croatian: Prikazane su prema učestalosti pomoću sljedeće konvencije: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (< 1/10 000), uključujući izolirane prijave.
English: If you stop taking Edarbi, your blood pressure may increase again.
Croatian: Ako prestanete uzimati Edarbi, krvni tlak Vam se može ponovno povisiti.
English: Dual blockade of the RAAS
Croatian: Dvostruka blokada RAAS-a
English: Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Edarbi.
Croatian: Liječnik će Vam obično savjetovati da prestanete uzimati ovaj lijek prije nego zatrudnite ili čim saznate da ste trudni i reći će Vam da uzmete drugi lijek umjesto Edarbija.
English: Azilsartan is metabolised to two primary metabolites.
Croatian: Azilsartan se metabolizira do dva primarna metabolita.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i drugi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: This leaflet was last approved in {MM/YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}.
English: Overall, 51% of patients were male and 26% were 65 years or older (5% ≥ 75 years); 67% were white and 19% were black.
Croatian: Među bolesnicima je bilo 51% muškaraca, a 26% bolesnika bilo je u dobi od 65 ili više godina (5% ≥ 75 godina); 67% bili su bijelci, a 19% crnci.
English: The safety and efficacy of Edarbi in children and adolescents aged 0 to < 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Edarbija u djece i adolescenata u dobi od 0 do < 18 godina još nisu ustanovljene.
English: If you take more Edarbi than you should
Croatian: Ako uzmete više Edarbija nego što ste trebali
English: However it should be taken into account that occasionally dizziness or tiredness may occur.
Croatian: Međutim, potrebno je uzeti u obzir da povremeno mogu nastati omaglica i umor.
English: Characteristics in specific groups of patients
Croatian: Značajke u posebnim skupinama bolesnika
English: This medicine is used for treating high blood pressure (essential hypertension) in adult patients (over 18 years of age).
Croatian: Ovaj se lijek primjenjuje za liječenje povišenog krvnog tlaka (esencijalna hipertenzija) u odraslih bolesnika (u dobi iznad 18 godina).
English: The major enzyme responsible for azilsartan metabolism is CYP2C9.
Croatian: Glavni enzim odgovoran za metabolizam azilsartana je CYP2C9.
English: If you take too many tablets, or if someone else takes your medicine, contact your doctor immediately.
Croatian: Ako uzmete previše tableta ili ako je netko drugi uzeo Vaše tablete, odmah se obratite liječniku.
English: Azilsartan is highly bound to plasma proteins (> 99%), mainly serum albumin.
Croatian: Azilsartan se u visokom postotku veže za proteine plazme (> 99%), uglavnom serumski albumin.
English: Hemoglobin and hematocrit
Croatian: Hemoglobin i hematokrit
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja u životinja pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: Therefore do not stop taking Edarbi without first talking to your doctor about alternative treatment options.
Croatian: Stoga nemojte prestati uzimati Edarbi a da prethodno niste razgovarali s liječnikom o drugim mogućnostima liječenja.
English: Pharmacokinetics of azilsartan do not differ significantly between young (age range 18-45 years) and elderly (age range 65-85 years) patients.
Croatian: Farmakokinetika azilsartana ne razlikuje se značajno između mlađih (u dobi od 18 do 45 godina) i starijih (u dobi od 65 do 85 godina) bolesnika.
English: Edarbi can affect the way some other medicines work and some medicines can have an effect on Edarbi.
Croatian: Edarbi može utjecati na način na koji djeluju neki drugi lijekovi, kao što i neki lijekovi mogu imati učinak na Edarbi.
English: Edarbi had a lower incidence of cough (1.2%) compared with ramipril (8.2%).
Croatian: Edarbi je imao nižu incidenciju kašlja (1,2%) u usporedbi s ramiprilom (8,2%).
English: - Second and third trimester of pregnancy (see sections 4.4 and 4.6).
Croatian: - Drugo i treće tromjesečje trudnoće (vidjeti dio 4.4 i 4.6).
English: Many of these elevations were transient or nonprogressive while subjects continued to receive treatment.
Croatian: U mnogim su slučajevima ta povišenja bila prolazna ili neprogresivna dok su se ispitanici nastavljali liječiti.
English: Rebound hypertension was not observed following abrupt cessation of Edarbi therapy after 6 months of treatment.
Croatian: Nije bila opažena povratna hipertenzija nakon naglog prekida terapije Edarbijem nakon 6 mjeseci liječenja.
English: What Edarbi is and what it is used for
Croatian: Što je Edarbi i za što se koristi
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to angiotensin converting enzyme inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded.
Croatian: Epidemiološki dokazi u pogledu rizika teratogenosti nakon izlaganja inhibitorima angiotenzinkonvertirajućeg enzima tijekom prvog tromjesečja trudnoće nisu konačni; međutim, ne može se isključiti malo povećanje rizika.
English: The frequency of this effect is highest when amlodipine is taken alone.
Croatian: Učestalost ovog učinka najveća je kad se amlodipin uzima sam.
English: Talk to your doctor before taking Edarbi, especially if you - have kidney problems.
Croatian: Obratite se svom liječniku prije nego primijenite Edarbi, posebno: - ako imate tegobe s bubrezima.
English: Effect on cardiac repolarisation
Croatian: Učinak na srčanu repolarizaciju
English: Therefore, adequate hydration and monitoring of renal function at the beginning of the treatment are recommended.
Croatian: Stoga se preporučuje primjerena hidracija i praćenje funkcije bubrega na početku liječenja.
English: What Edarbi looks like and contents of the pack
Croatian: Kako Edarbi izgleda i sadržaj pakiranja
English: Date of first authorisation: 7 December 2011 Date of latest renewal:
Croatian: Datum prvog odobrenja: 7. prosinca 2011.
English: Edarbi is indicated for the treatment of essential hypertension in adults.
Croatian: Edarbi je indiciran za liječenje esencijalne hipertenzije u odraslih.
English: Your doctor may increase this dose to a maximum of 80 mg once a day depending on blood pressure response.
Croatian: Liječnik Vam može povisiti dozu na najviše 80 mg jedanput na dan, ovisno o odgovoru krvnog tlaka.
English: Edarbi is for oral use and may be taken with or without food (see section 5.2).
Croatian: Edarbi je namijenjen za peroralnu primjenu i može se uzimati s hranom ili bez nje (vidjeti dio 5.2).
English: If symptomatic hypotension should occur, supportive treatment should be instituted and vital signs monitored.
Croatian: Ako nastupi simptomatska hipotenzija, potrebno je uvesti potporno liječenje i pratiti vitalne znakove.
English: What Edarbi contains
Croatian: Što Edarbi sadrži
English: Food does not affect the bioavailability of azilsartan (see section 4.2).
Croatian: Hrana ne utječe na bioraspoloživost azilsartana (vidjeti dio 4.2).
English: Therefore, the use of Edarbi is not recommended in these patients.
Croatian: Stoga se ne preporučuje primjena Edarbija u tih bolesnika.
English: Do NOT take Edarbi if you - are allergic to azilsartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Edarbi ako ste - alergični na azilsartanmedoksomil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: No dose adjustment is necessary based on gender.
Croatian: Nije potrebna prilagodba doze na temelju spola.
English: This effect is also seen with other inhibitors of the RAAS.
Croatian: Ovaj je učinak bio opažen i s drugim inhibitorima RAAS-a.
English: Edarbi is provided in blisters with either 14 tablets or 15 tablets in cartons containing 14, 28, 56 or 98 tablets and blisters integrated with desiccant with either 14 tablets or 15 tablets in cartons containing 14, 28, 30, 56, 90 or 98 tablets.
Croatian: Edarbi je pakiran u blister pakiranjima sa 14 tableta ili 15 tableta unutar kutija koje sadrže 14, 28, 56ili 98 tableta i u blisterima s ugrađenim sredstvom za sušenje sa 14 ili 15 tableta unutar kutija koje sadrže 14, 28, 30, 56, 90 ili 90 tableta.
English: In patients with mild, moderate, and severe renal impairment azilsartan total exposure (AUC) was +30%, +25% and +95% increased.
Croatian: U bolesnika s blagim, umjerenim i teškim oštećenjem funkcije bubrega, ukupna izloženost azilsartanu (AUC) bila je povećana za +30%, +25% odnosno +95%.
English: What Edarbi is and what it is used for What you need to know before you take Edarbi How to take Edarbi
Croatian: Što je Edarbi i za što se koristi Što morate znati prije nego počnete uzimati Edarbi
English: Beneficial effects of Edarbi on mortality and cardiovascular morbidity and target organ damage are currently unknown.
Croatian: Korisni učinci Edarbija na smrtnost i kardiovaskularni pobol te oštećenje ciljnog organa trenutno nisu poznati.
English: The dose may be increased to a maximum of 80 mg once daily for patients whose blood pressure is not adequately controlled at the lower dose.
Croatian: Doza se može povisiti na najviše 80 mg jedanput na dan u bolesnika čiji se krvni tlak ne može kontrolirati nižom dozom na odgovarajući način.
English: Paediatric population The pharmacokinetics of azilsartan have not been studied in children under 18 years of age.
Croatian: Pedijatrijska populacija Farmakokinetika azilsartana nije ispitana u djece u dobi manjoj od 18 godina.
English: In the reproduction toxicity studies, there were no effects on male or female fertility.
Croatian: U ispitivanjima reproduktivne toksičnosti nije bilo učinaka na plodnost u mužjaka ili ženki.
English: Aluminum blisters
Croatian: Aluminijski blisteri
English: No dose adjustment is necessary based on race.
Croatian: Nije potrebna prilagodba doze na temelju rase.
English: There is currently no experience on the use of Edarbi in patients who have recently undergone kidney transplantation.
Croatian: Trenutno nema iskustva s primjenom Edarbija u bolesnika kojima je nedavno presađen bubreg.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake “EXP”.
English: Patients with primary hyperaldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the RAAS.
Croatian: Bolesnici s primarnim hiperaldosteronizmom općenito neće imati terapijski dogovor na antihipertenzivne lijekove koji djeluju putem inhibicije RAAS-a.
English: What you need to know before you take Edarbi
Croatian: Što morate znati prije nego počnete uzimati Edarbi
English: The elimination half-life of azilsartan is approximately 11 hours and renal clearance is approximately 2.3 ml/min.
Croatian: Poluvijek eliminacije azilsartana iznosi približno 11 sati, a bubrežni klirens približno 2,3 ml/min.
English: No increase (+5%) was observed in end-stage renal disease patients who were dialysed.
Croatian: Nije opaženo povećanje (+5%) u bolesnika sa završnim stadijem bubrežne bolesti koji su bili na dijalizi.
English: - The usual starting dose is 40 mg once a day.
Croatian: Uobičajena početna doza je 40 mg jedanput na dan.
English: Whilst there are no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of medicinal products.
Croatian: Iako nema kontroliranih epidemioloških podataka o riziku primjene antagonista receptora angiotenzina II, mogu postojati slični rizici za cijelu klasu lijekova.
English: Excessive blood pressure decreases in patients with ischaemic cardiomyopathy or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
Croatian: Preveliko sniženje krvnog tlaka u bolesnika s ishemijskom kardiomiopatijom ili ishemijskom cerebrovaskularnom bolešću može dovesti do infarkta miokarda ili moždanog udara.