FrancophonIA/ELRC3.0 huggingface dataset:
English: Antifibrinolytics (e.g. aprotinin, aminocaproic acid and tranexamic acid), are a class of haemostatic agents used to prevent excessive blood loss.
Croatian: Antifibrinolitici (npr. aprotinin, aminokaproična kiselina i traneksamična kiselina), klasa su hemostatika koji se koriste za sprječavanje prekomjernog gubitka krvi.
English: A restricted distribution of aprotinin is envisaged with aprotinin available only to centres that perform cardiac surgery on cardio-pulmonary bypass and that commit to participate in the registry.
Croatian: Predviđa se ograničena distribucija aprotinina s tim da je aprotinin dostupan samo centrima koja provode kirurške zahvate s ugradnjom kardiopulmonalnih premosnica i koji se slažu da sudjeluju u registru.
English: In March 2010 Germany triggered an article 31 referral to assess the benefits and risks of the antifibrinolytic drugs aprotinin, EACA and TXA in all their approved indications.
Croatian: Njemačka je potaknula postupak povezan s člankom 31 kako bi se procijenile koristi i rizici antifibrinolitičkih lijekova aprotinina, aminokaproične kiseline i traneksamične kiseline u svim odobrenim indikacijama.
English: 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.
Croatian: Smanjenje masivnog krvarenja, potreba za transfuzijom i rizik od ponovnog kirurškog zahvata zbog krvarenja smatraju se značajnim, klinički važnim učincima aprotinina te kad se uzmu u obzir svi podaci o poznatim rizicima, CHMP smatra da je u identificiranoj populaciji bolesnika omjer koristi i rizika jasno pozitivan.
English: • 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.
Croatian: • Povjerenstvo je razmotrilo sve podatke primljene pismenim putem od nositelja odobrenja te usmena objašnjenja, uključujući podatke iz literature i zaključaka znanstvene savjetodavne grupe.
English: 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.
Croatian: Cjelokupno gledano, CHMP smatra da ispitivanje BART nije bilo osmišljeno da bi se pouzdano odredio rizik od smrti povezan s aprotininom u odnosu na EACA ili TXA, i veća smrtnost opažena u rezultatima za bolesnike liječene aprotininom može biti slučajnost.
English: • 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.
Croatian: • Povjerenstvo je zaključilo da dokazi randomiziranih kliničkih ispitivanja i studija opažanja podupiru upotrebu aprotinina za smanjenje incidencije masivnog krvarenja, potrebe za transfuzijom krvnih preparata i potrebu za ponovljenim kirurškim zahvatom zbog krvarenja.
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Aprotinin containing medicinal products (see Annex I)
Croatian: Cjelokupni sažetak znanstvene procjene karakteristika antifibrinolitika Lijekovi koji sadrže aprotinin (vidjeti Dodatak I)
English: The marketing authorisations for aprotinin were suspended when concerns over its safety were raised in a previous review in 2007.
Croatian: Davanja odobrenja za aprotinin bila su suspendirana kada je prethodna revizija 2007. godine potaknula zabrinutost u odnosu na sigurnost primjene aprotinina.
English: The CHMP noted that since the initial review in 2007, more data has become available, in particular the final study results, and more importantly new analysis of the BART study.
Croatian: CHMP navodi da je od prve revizije 2007. postalo dostupno više podataka, posebice rezultati konačnog ispitivanja i što je još važnije, nova analiza ispitivanja BART.
English: The preliminary results of a randomised controlled clinical trial, the ‘Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population' (BART) study, had shown that although the use of aprotinin was associated with less serious bleeding than either of the comparator drugs, an increase in 30 day all-cause mortality had been observed among patients receiving aprotinin compared to patients taking other medicines.
Croatian: Prema preliminarnim rezultatima randomiziranog kontroliranog kliničkog ispitivanja 'Čuvanje krvi primjenom antifibrinolitika: randomizirano ispitivanje u populaciji s kirurškim zahvatima na srcu' (Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population, BART) iako je primjena aprotinina bila povezana s manje ozbiljnim krvarenjem nego oba usporedbena lijeka, tijekom 30 dana opažen je porast smrtnosti zbog svih uzroka među bolesnicima koji su primali aprotinin u usporedbi s bolesnicima koji su uzimali druge lijekove.
English: 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.
Croatian: To što je uz aprotinin dokazano smanjenje potrebe za ponovljenim kirurškim zahvatom nakon ugradnje aortokoronarne premosnice (CABG), smatra se koristi od velikog kliničkog značenja.
English: 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.
Croatian: Znanstveni zaključci i razlozi ukidanja suspenzije te promjena i dopuna davanja odobrenja određene su u Dodatku II mišljenja.
English: 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).
Croatian: CHMP smatra da je djelotvornost aprotinina jasno dokazana u prospektivnim randomiziranim ispitivanjima i metaanalizi kliničkih ispitivanja koja pokazuju da aprotinin smanjuje incidenciju masivnog krvarenja, smanjuje potrebu za transfuzijom krvnih preparata i smanjuje potrebu za ponovnim kirurškim zahvatom zbog krvarenja u bolesnika kojima je prilikom operacije srca potrebna kardiopulmonalna obilaznica (CPB).
English: The CHMP noted that since the initial review in 2007, more data has become available, such as new observational studies, the final study results of the BART study, and more importantly new analyses of the BART study.
Croatian: CHMP navodi da je od prve revizije 2007. godine postalo dostupno više podataka, kao što su nove studije opažanja, konačni rezultati ispitivanja BART i što je još važnije, nove analize ispitivanja BART.
English: 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.
Croatian: U izravnom priopćenju zdravstvenim djelatnicima (DHPC) usuglašeno je da se liječnicima koji će propisivati lijek navedu informacije o ovoj reviziji i ažurirane sigurnosne informacije za aprotinin.
English: • The Committee considered that the available randomised clinical trial and meta-analysis of clinical trials (when the BART study is excluded) do not give evidence of an association between aprotinin and perioperative mortality.
Croatian: • Povjerenstvo smatra da dostupno randomizirano kliničko ispitivanje i metaanaliza kliničkih ispitivanja (uz isključeno ispitivanje BART) ne dokazuju povezanost između aprotinina i perioperacijske smrtnosti.
English: The CHMP noted that the findings from other randomised clinical trials and meta-analysis of randomised clinical trials (when the BART study is excluded) do not provide evidence of an association between aprotinin and perioperative mortality.
Croatian: CHMP je uočio da nalazi drugih randomiziranih kliničkih ispitivanja i metaanaliza randomiziranih kliničkih ispitivanja (kada se isključi ispitivanje BART) ne pružaju dokaz povezanosti između aprotinina i perioperacijske smrtnosti.
English: Taking the totality of data into account it is judged that the previous signal for an increased mortality associated with the use of aprotinin should be refuted provided that the drug is given in the identified target population of adult patients at high risk of major blood loss undergoing isolated coronary artery bypass graft (CABG) surgery and the recommendations for its use are followed.
Croatian: Uzimajući u obzir sveukupne podatke zaključak je da prijašnje upozorenje o povećanoj smrtnosti povezanoj s primjenom aprotinina treba odbaciti, uz uvjet da se lijek daje identificiranoj ciljanoj populaciji odraslih bolesnika koja je pod velikim rizikom od velikog gubitka krvi zbog izoliranog kirurškog zahvata ugradnje aortokoronarne premosnice (CABG) te uz pridržavanje preporuka za upotrebu aprotinina.
English: Aprotinin was already indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in those patients undergoing CPB in the course of CABG who were at an increased risk for blood loss and blood transfusion.
Croatian: Aprotinin je već bio indiciran za profilaktičku upotrebu radi smanjenja perioperacijskog gubitka krvi i potrebe za transfuzijom krvi u onih bolesnika podvrgnutih postupku CABG primjenom kardiopulmonalne obilaznice koji su bili pod povećanim rizikom od gubitka krvi i potrebe za transfuzijom krvi.
English: The registry, which will be mandatory for use of the product, will monitor the pattern of use in participating countries and record utilisation information.
Croatian: CHMP smatra da nositelji odobrenja za lijekove koji sadrže aprotinin, i na koje se odnosi ova revizija, moraju provesti ispitivanje (registar) koje će biti obavezno za primjenu proizvoda, nadzirat će obrazac upotrebe u zemljama sudionicama i bilježiti podatke o korištenju.
English: Scientific conclusions and grounds for lifting of the suspension and amendment of the marketing authorisations for aprotinin containing medicinal products presented by the EMA
Croatian: Znanstveni zaključci i razlozi za ukidanje suspenzije te izmjena i dopuna odobrenja za stavljanje lijeka u promet za lijekove koji sadrže aprotinin Europske agencije za lijekove
English: Grounds for lifting of the suspension and amendment of the marketing authorisations of aprotinin containing medicinal products listed in Annex I
Croatian: Razlozi za ukidanje suspenzije i dopunu odobrenja za stavljanje lijeka u promet za lijekove koji sadrže aprotinin navedene u Dodatku
English: Aprotinin is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Croatian: Aprotinin indiciran za profilaktičku primjenu radi smanjenja gubitka krvi i potrebe za transfuzijom krvi u odraslih bolesnika koji su pod visokim rizikom od velikog gubitka krvi zbog izoliranog kirurškog zahvata kardiopulmonalne premosnice (tj.kirurški zahvat ugradnje premosnice koronarne arterije koji nije kombiniran s drugim kardiovaskularnim zahvatom).
English: The marketing authorisations of EACA and TXA were not affected by the initial 2007 review.
Croatian: Inicijalna revizija 2007. godine nije utjecala na davanje odobrenja za aminokaproičnu kiselinu i traneksamičnu kiselinu.
English: 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.
Croatian: Na temelju gore navedenog Povjerenstvo preporučuje ukidanje suspenzije i izmjenu i dopunu odobrenja za stavljanje lijeka u promet za lijekove koji sadrže aprotinin navedenih u Dodatku
English: The proposed indication is for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Croatian: Predložena indikacija odnosi se na profilaktičku upotrebu radi smanjenja gubitka krvi i potrebe za transfuzijom u odraslih bolesnika koji su tijekom izoliranog kirurškog zahvata ugradnje aortokoronarne premosnice (tj. kirurški zahvat ugradnje premosnice koronarne arterije koji nije kombiniran s drugim kardiovaskularnim zahvatom) pod visokim rizikom od velikog gubitka krvi.
English: The quality review of documents templates were taken into account during this review.
Croatian: Ta je revizija obuhvaćala i provjeru kvalitete predložaka dokumenata.
English: prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Croatian: profilaktička upotreba radi smanjenja gubitka krvi i potrebe za transfuzijom krvi u odraslih bolesnika koji su pod visokim rizikom od velikog gubitka krvi zbog izoliranog kirurškog zahvata ugradnje aortokoronarne premosnice (tj. CABG koji se ne kombinira s drugim kardiovaskularnim zahvatom) 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: It is especially important that you tell your doctor if you are also taking:
Croatian: Osobito je važno da obavijestite liječnika ako uzimate:
English: You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Croatian: Stoga morate biti oprezni dok upravljate vozilima, radite sa strojevima ili obavljate druge zadatke koji zahtijevaju Vašu punu pozornost.
English: Date of latest renewal: 20th November 2018
Croatian: Datum prvog odobrenja: 16.01.2014 Datum posljednje obnove odobrenja: 20. studenog 2018
English: If any of these apply to you, tell your doctor straight away.
Croatian: Ako se bilo što od ovoga odnosi na Vas, odmah obavijestite svog liječnika.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.1, međutim, nije moguće dati preporuku o doziranju.
English: Very common (may affect more than 1 in 10 people): • Low level of phosphate in the blood.
Croatian: Vrlo često (može se javiti u više od 1 na 10 osoba): • niska razina fosfata u krvi.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, i ovaj lijek može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: • The unopened vial does not require any specific storage conditions.
Croatian: • Neotvorena bočica ne zahtijeva posebne uvjete čuvanja.
English: • Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Croatian: • Liječnik će Vam savjetovati da prije svakog liječenja popijete dovoljnu količinu vode, kako bi se spriječila dehidracija.
English: Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Croatian: Pozornost zahtijeva i mogućnost razvoja hipomagnezemije tijekom liječenja.
English: Packs containing 1, 4 or 10 vials.
Croatian: Pakiranja koja sadrže 1, 4 ili 10 bočica.
English: Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Croatian: Obratite se svom liječniku za savjet prije nego što uzmete bilo koji lijek tijekom trudnoće ili dojenja.
English: • Fainting due to low blood pressure.
Croatian: • nesvjestica zbog niskog krvnog tlaka.
English: Cases of severe hypocalcaemia requiring hospitalisation have been reported.
Croatian: Zabilježeni su slučajevi teške hipokalcemije koji su zahtijevali hospitalizaciju.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.>
English: Anxiety, sleep disturbance
Croatian: anksioznost, poremećaj spavanja
English: NR NR NR 640
Croatian: ND 640
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je omjer korist/rizik rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilanciej ili smanjenja rizika).
English: Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.
Croatian: Bolesnicima čije razine kalcija u krvi nisu previsoke također će biti propisan kalcij i vitamin D koje moraju uzimati svaki dan.
English: • Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Croatian: • teška alergijska reakcija: nedostatak zraka, oteklina koja uglavnom zahvaća lice i grlo.
English: The safety and efficacy of zoledronic acid in children aged 1 year to 17 years have not been established.
Croatian: Sigurnost i djelotvornost zoledronatne kiseline u djece u dobi od 1 do 17 godina nije ustanovljena.
English: Other medicines and Zoledronic Acid Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Zoledronatna kiselina Accord Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • Blurred vision, tearing of the eye, eye sensitivity to light.
Croatian: • zamagljen vid, suzenje oka, osjetljivost očiju na svjetlost.
English: Nausea, vomiting, decreased appetite
Croatian: mučnina, povraćanje, smanjeni apetit
English: Zoledronic Acid Accord can be given to people aged 65 years and over.
Croatian: Zoledronatna kiselina Accord može se davati osobama u dobi od 65 ili više godina.
English: This medicinal product does not require any special storage condition.
Croatian: Ovaj lijek ne zahtijeva posebne uvjete čuvanja.
English: Treatment of TIH Adults and older people
Croatian: Odrasli i starije osobe
English: The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Croatian: Mehanizam koji je dovodio do povećane incidencije atrijske fibrilacije u tom jednom kliničkom ispitivanju nije poznat.
English: Healthcare professionals are advised not to dispose of unused Zoledronic Acid Accord via the domestic sewage system.
Croatian: Zdravstvenim djelatnicima se savjetuje da ne uklanjaju neiskorištenu Zoledronatnu kiselinu Accord putem kanalizacijskog sustava.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PREKLOPNA KUTIJA
English: The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Croatian: Ukupni klirens iz tijela iznosi 5,04 ± 2,5 l/h, ne ovisi o dozi i na njega ne utječu spol, dob, rasa ni tjelesna težina.
English: • Low counts of white blood cells and blood platelets.
Croatian: • nizak broj bijelih krvnih stanica i krvnih pločica.
English: • if you have or have had a kidney problem.
Croatian: • imate ili ste imali tegobe s bubrezima
English: • Hypersensitivity reactions.
Croatian: • reakcije preosjetljivosti.
English: • Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
Croatian: • intersticijska bolest pluća (upala tkiva oko zračnih vrećica u plućima).
English: Your doctor, pharmacist or nurse knows how to store Zoledronic Acid Accord properly (see section 6).
Croatian: Vaš liječnik, ljekarnik ili medicinska sestra znaju kako ispravno čuvati Zoledronatnu kiselinu Accord (vidjeti dio 6).
English: The frequencies for each of these identified risks are shown in Table 1.
Croatian: Učestalost svakog pojedinog utvrđenog rizika navedena je u tablici 1.
English: • Low level of red blood cells (anaemia).
Croatian: • smanjeni broj crvenih krvnih stanica (anemija).
English: • Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zoledronic Acid Accord.
Croatian: • Ispitivanja s nekoliko vrsta infuzijskih linija napravljenih od polivinilklorida, polietilena i polipropilena pokazala su da nema inkompatibilnosti sa Zoledronatnom kiselinom Accord.
English: • Chemical and physical in-use stability has been demonstrated for 36 hours at 2 - 8 °C.
Croatian: • Dokazana kemijska i fizikalna stabilnost iznosi 36 sati na temperaturi od 2 - 8°C.
English: Additional information on handling of Zoledronic Acid Accord, including guidance on preparation of reduced doses, is provided in section 4.2.
Croatian: Dodatne informacije o rukovanju Zoledronatnom kiselinom Accord, uključujući upute za pripremu sniženih doza, nalaze se u dijelu 4.2.
English: Zoledronic acid 4 mg (N=86) 45.3% (p=0.104) 82.6% (p=0.005)* 88.4% (p=0.002)* Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Croatian: Zoledronatna kiselina 4 mg (N=86) 45,3% (p=0,104) 82,6% (p=0,005)* 88,4% (p=0,002)* Zoledronatna kiselina 8 mg (N=90) 55,6% (p=0,021)* 83,3% (p=0,010)* 86,7% (p=0,015)* Pamidronat 90 mg (N=99) *p-vrijednosti u usporedbi s pamidronatom.
English: If a lower dose of Zoledronic Acid Accord is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Croatian: Ako je potrebna niža doza Zoledronatne kiseline Accord, prvo izvucite odgovarajući volumen kako je navedeno niže, i potom ga dodatno razrijedite sa 100 ml otopine za infuziju.
English: • Low level of calcium in the blood.
Croatian: • niska razina kalcija u krvi.
English: • Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Croatian: • reakcije probavnog sustava, kao što su mučnina i povraćanje, kao i gubitak apetita.
English: 319, Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom
Croatian: 319, Pinner Road North Harrow, Middlesex HA1 4HF Ujedinjeno Kraljevstvo
English: 319 Pinner Road North Harrow Middlesex, HA1 4HF United Kingdom
Croatian: 319 Pinner Road North Harrow Middlesex, HA1 4HF Ujedinjeno Kraljevstvo
English: Zoledronic Acid Accord is not recommended for use in adolescents and children below the age of 18 years.
Croatian: Ne preporučuje se primjena lijeka Zoledronatne kiseline Accord u adolescenata i djece mlađe od 18 godina.
English: • Increased sweating.
Croatian: • pojačano znojenje
English: • Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
Croatian: • Pažljivo slijedite sve druge upute koje su Vam dali liječnik, ljekarnik ili medicinska sestra.