FrancophonIA/ELRC3.0 huggingface dataset:
English: Mortality Information on mortality from randomized clinical trials is provided in section 5.1.
Croatian: Smrtnost Informacije o smrtnosti iz randomiziranih kliničkih ispitivanja prikazane su u dijelu 5.1.
English: Re-exposure to aprotinin
Croatian: Ponovno izlaganje aprotininu
English: Animal studies did not provide any evidence of teratogenic or other embryotoxic effects of aprotinin.
Croatian: Ispitivanja na životinjama nisu dala nikakve dokaze teratogenih ili drugih embriotoksičnih učinaka aprotinina.
English: MedDRA Standard System organ class
Croatian: MedDRA Standardna klasifikacija organskih sustava
English: You will receive a small amount of <Aprotinin-containing medicinal product> (1 ml) before the operation begins, to test if you are allergic to the <Aprotinin-containing medicinal product>.
Croatian: Dobit ćete malu količinu <lijeka koji sadrži aprotinin> (1 ml) prije početka operacije da bi se provjerilo jeste li alergični na <lijek koji sadrži aprotinin>.
English: - You have or suspect you have received aprotinin or aprotinin containing fibrin sealants in the last 12 months.
Croatian: - Primili ste ili sumnjate da ste primili aprotinin ili fibrinsko ljepilo koje sadrži aprotinin u prethodnih 12 mjeseci.
English: In general, you will not be given more than 700 ml of <Aprotinin-containing medicinal product> at any one time.
Croatian: Općenito, nikada nećete dobiti više od 700 ml <lijeka koji sadrži aprotinin>.
English: In case of re-exposure the incidence of allergic/anaphylactic reactions may reach the five percent level.
Croatian: U slučaju ponovnog izlaganja, incidencija alergijskih/anafilaktičkih reakcija može dosegnuti razinu od pet posto.
English: However, since aprotinin is not bioavailable after oral administration, any drug contained in the milk is not expected to have a systemic effect on the breast-feed child.
Croatian: Međutim, budući da aprotinin nije bioraspoloživ nakon peroralne primjene, ne očekuje se da će bilo koja količina lijeka sadržana u majčinom mlijeku imati sistemski učinak na dojeno dijete.
English: However, due to several methodological deficiencies no firm conclusion on cardiovascular risks can be made on the BART study results.
Croatian: Međutim, zbog nekoliko metodoloških nedostataka, na temelju rezultata ispitivanja BART ne može se donijeti čvrsti zaključak o kardiovaskularnim rizicima.
English: Therefore, the partial thromboplastin time (PTT) should not be used to maintain adequate anticoagulation with heparin.
Croatian: Stoga se parcijalno tromboplastinsko vrijeme (PTT) ne smije koristiti za održavanje odgovarajuće antikoagulacije heparinom.
English: The symptoms of allergic/anaphylactic reactions may include: Respiratory system:
Croatian: Simptomi alergijskih/anafilaktičkih reakcija mogu uključivati: Respiratorni sustav:
English: If you are given more <Aprotinin-containing medicinal product> than the recommended dose
Croatian: Ako dobijete više <lijeka koji sadrži aprotinin> od preporučene doze
English: Graft Conservation Blood drawn from the aprotinin central infusion line should not be used for graft preservation.
Croatian: Krv koja se izvuče iz centralne infuzijske linije za aprotinin ne smije se koristiti za konzerviranje presatka.
English: <Aprotinin-containing medicinal product> will only be given if your doctor has done blood tests before to check you are suitable (e.g. an appropriate aprotinin-specific IgG antibody test), otherwise other medicines may be a better option for you.
Croatian: <Lijek koji sadrži aprotinin> će Vam se dati samo ako Vam je liječnik prethodno proveo krvne pretrage da provjeri jeste li pogodni (npr. odgovarajući test na IgG protutijelo specifično za aprotinin); u suprotnom, drugi lijekovi su možda bolji izbor za Vas.
English: If allergic reactions occur during injection or infusion, administration should be stopped immediately.
Croatian: Ako tijekom injiciranja ili infuzije nastane alergijska reakcija, primjena se mora odmah zaustaviti.
English: If there are no signs of allergy, you will be given 100-200 ml <Aprotinin-containing medicinal product> over 20 to 30 minutes, followed by 25 - 50 ml per hour (max. 5 - 10 ml/min) until the end of the operation.
Croatian: Ako nema znakova alergije, dobit ćete 100 - 200 ml <lijeka koji sadrži aprotinin> tijekom 20 do 30 minuta, a zatim 25 - 50 ml po satu (najviše 5 - 10 ml/min) sve do kraja operacije.
English: Available clinical experience suggests that patients with decreased renal function do not require special dose adjustment.
Croatian: Dostupno kliničko iskustvo ukazuje na to da u bolesnika sa smanjenom funkcijom bubrega nije potrebna posebna prilagodba doze.
English: An ACT is not a standardized coagulation test, and different formulations of the assay are affected differently by the presence of aprotinin.
Croatian: ACT nije standardizirani koagulacijski test i prisutnost aprotinina drugačije djeluje na različite formulacije za test.
English: In these studies, aprotinin was usually administered to patients who had more risk factors for increased mortality before surgery than patients in the other treatment groups.
Croatian: U tim se ispitivanjima aprotinin obično primjenjivao bolesnicima koji su imali više čimbenika rizika za povećanu smrtnost prije operacije nego bolesnici u drugim terapijskim skupinama.
English: Therefore, administration of aprotinin is contraindicated in these patients.
Croatian: Stoga je primjena aprotinina u ovih bolesnika kontraindicirana.
English: A special dose adjustment is not warranted.
Croatian: Nije obavezna posebna prilagodba doze.
English: Aprotinin is a broad spectrum protease inhibitor which has antifibrinolytic properties.
Croatian: Aprotinin je inhibitor proteaze širokog spektra koji ima antifibrinolitička svojstva.
English: Arterial thrombosis (and its organ specific manifestations that might occur in vital organs such as kidney, lung or brain)
Croatian: Krvožilni poremećaji tromboza arterijska tromboza (i njezine manifestacije specifične za organ koje mogu nastati u vitalnim organima kao što su bubreg, pluća ili mozak)
English: - Your kidneys do not work properly.
Croatian: Vam ne rade ispravno.
English: Daily doses of up to 100,000 KIU/kg did not interfere with the growth and development of the young, and doses of 200,000 KIU/kg/day were not teratogenic.
Croatian: Dnevne doze do 100 000 KIU/kg nisu ometale rast i razvoj mladunčadi, a doze od 200 000 KIU/kg na dan nisu bile teratogene.
English: Important: aprotinin is not a heparin-sparing agent.
Croatian: Važno: aprotinin nije sredstvo koje štedi heparin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally]
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV [Ispunjava država članica]
English: In rats, guinea-pigs, rabbits and dogs, high doses (>150.000 KIU/kg) injected quickly caused a blood pressure reduction of varying magnitude, which rapidly subsided.
Croatian: U štakora, zamoraca, kunića i pasa, injicirane visoke doze (>150 000 KIU/kg) brzo su dovele do sniženja krvnog tlaka različitog stupnja, no to je naglo prestalo.
English: It is recommended that your doctor/surgeon should, in addition to <Aprotinin-containing medicinal product>, administer heparin (a medicine used to prevent blood clots) before and during the operation.
Croatian: Preporučuje se da Vaš liječnik/kirurg, uz <lijek koji sadrži aprotinin>, primijeni i heparin (lijek za sprječavanje krvnih ugrušaka) prije i tijekom operacije.
English: The most serious adverse reaction was myocardial infarction.
Croatian: Najozbiljnija nuspojava bila je infarkt miokarda.
English: Even when a second exposure to aprotinin has been tolerated without symptoms, a subsequent administration may result in severe allergic reactions or anaphylactic shock with, in very rare cases, fatal outcome.
Croatian: Čak i kad se drugo izlaganje aprotininu podnijelo bez simptoma, daljnja primjena može dovesti do teških alergijskih reakcija ili anafilaktičkog šoka koji, u vrlo rijetkim slučajevima, ima smrtni ishod.
English: Pulmonary embolism
Croatian: plućna embolija
English: Aprotinin should be infused using a central venous catheter.
Croatian: Aprotinin treba dati infuzijom kroz centralni venski kateter.
English: A loading dose of 1 - 2 million KIU is administered as a slow intravenous injection or infusion over 20 - 30 minutes after induction of anaesthesia and prior to sternotomy.
Croatian: Udarna doza od 1 - 2 milijuna KIU primjenjuje se kao spora intravenska injekcija ili infuzija u trajanju od 20 - 30 minuta nakon uvođenja anestezije i prije sternotomije.
English: Your doctor will evaluate the dose of heparin based from the results from tests of your blood.
Croatian: Vaš će liječnik procijeniti dozu heparina na temelju rezultata Vaših krvnih pretraga.
English: After receiving injections of 131I-aprotinin healthy volunteers excreted within 48 hours 25 - 40 % of the labelled substance as metabolites in the urine.
Croatian: Nakon primanja injekcija 131I-aprotinina, u zdravih se dobrovoljaca unutar 48 sati izlučilo 25 - 40 % označene tvari u obliku metabolita u mokraći.
English: In man, urinary excretion of active aprotinin accounts for less than 5 % of the dose.
Croatian: U čovjeka, aktivni aprotinin izlučen mokraćom čini manje od 5 % doze.
English: The symptoms of an allergic reaction may include: breathing difficulties reduced blood pressure itching, rash and hives feeling sick
Croatian: Simptomi alergijske reakcije mogu uključivati: otežano disanje snižen krvni tlak svrbež, osip i koprivnjaču mučninu
English: Aprotinin should only be used after careful consideration of the benefits and risks, and the consideration that alternative treatments are available (see section 4.4 and 5.1).
Croatian: Aprotinin se smije primijeniti samo nakon pažljivog razmatranja koristi i rizika i razmatranja drugih dostupnih liječenja (vidjeti dio 4.4 i 5.1).
English: The initial bolus infusion is followed by the administration of a continuous infusion of 250,000 - 500,000 KIU per hour until the end of the operation.
Croatian: Nakon početne bolus infuzije slijedi primjena kontinuirane infuzije od 250 000 - 500 000 KIU na sat sve do kraja operacije.
English: It is unknown whether aprotinin is excreted in human milk.
Croatian: Nije poznato izlučuje li se aprotinin u majčino mlijeko u ljudi.
English: Consult the manufacturer of the ACT test regarding the interpretation of the assay in the presence of aprotinin.
Croatian: Potražite savjet proizvođača ACT-testa kako tumačiti test u prisutnosti aprotinina.
English: All patients treated with aprotinin should first receive a test dose to assess the potential for allergic reactions (see section 4.2).
Croatian: Svi bolesnici liječeni aprotininom prvo trebaju primiti probnu dozu da bi se procijenila mogućnost nastanka alergijskih reakcija (vidjeti dio 4.2).
English: The safety and efficacy of <Aprotinin-containing medicinal product> in children below the age of 18 years have not been established.
Croatian: Djeca i adolescenti Sigurnost i djelotvornost <lijeka koji sadrži aprotinin> u djece mlađe od 18 godina nisu ustanovljene.
English: In the majority of instances, post-operative renal dysfunction was not severe and reversible.
Croatian: U većini slučajeva, poslijeoperacijski poremećaj funkcije bubrega nije bio težak i bio je reverzibilan.
English: Owing to the risk of allergic/anaphylactic reactions, a 1 ml (10,000 KIU) test dose should be administered to all patients at least 10 minutes prior to the remainder of the dose.
Croatian: Zbog rizika od alergijskih/anafilaktičkih reakcija, svim bolesnicima treba primijeniti probnu dozu od 1 ml (10 000 KIU) najmanje 10 minuta prije preostale doze.
English: Very rare: < 1/10,000
Croatian: Vrlo rijetko: <1/10 000
English: Although the majority of cases of anaphylaxis occur upon re-exposure within the first 12 months, there are also single case reports of anaphylaxis occurring upon re-exposure after more than 12 months.
Croatian: Iako većina slučajeva anafilaksije nastaje kod ponovnog izlaganja unutar prvih 12 mjeseci, zabilježeni su i pojedinačni slučajevi anafilaksije koji su nastali kod ponovnog izlaganja nakon više od 12 mjeseci.
English: Administration of aprotinin, especially to patients who have received aprotinin (including aprotinin containing fibrin sealants) in the past requires a careful risk/benefit assessment because an allergic reaction may occur (see sections 4.3 and 4.8).
Croatian: Primjena aprotinina, osobito bolesnicima koji su u prošlosti primili aprotinin (uključujući aprotinin kojeg sadrže fibrinska ljepila), zahtijeva pažljivu procjenu omjera rizika i koristi zato što može nastati alergijska reakcija (vidjeti dio 4.3 i 4.8).
English: <Aprotinin-containing medicinal product> can help to reduce the amount of blood loss you have during and after heart surgery.
Croatian: <Lijek koji sadrži aprotinin> može pridonijeti smanjenju količine gubitka krvi do kojeg dolazi tijekom i nakon operacije na srcu.
English: Allergic/anaphylactic reactions are rare in patients with no prior exposure to aprotinin.
Croatian: Alergijske/anafilaktičke reakcije rijetke su u bolesnika koji prethodno nikad nisu bili izloženi aprotininu.
English: In case of severe adverse drug reactions (like anaphylactic reaction, heart arrest, etc.) and their consecutive therapeutic measures, damage to the foetus has to be taken into account for a risk/benefit evaluation.
Croatian: U slučaju teških nuspojava (poput anafilaktičke reakcije, zastoja srca itd.) i posljedičnih terapijskih mjera, u procjeni omjera rizika i koristi mora se uzeti u obzir oštećenje fetusa.
English: A retrospective review showed that the incidence of an allergic/anaphylactic reaction following reexposure is increased when the re-exposure occurs within 6 months of the initial administration (5.0 % for re-exposure within 6 months and 0.9 % for re-exposures greater than 6 months).
Croatian: Retrospektivni pregled pokazao je da je incidencija alergijske/anafilaktičke reakcije nakon ponovnog izlaganja povećana kad se ponovno izlaganje dogodi unutar 6 mjeseci nakon prve primjene (5,0 % za ponovno izlaganje unutar 6 mjeseci i 0,9 % za ponovno izlaganje nakon više od 6 mjeseci).
English: <Aprotinin-containing medicinal product> will usually be given to you lying down by slow injection or infusion (through ‘a drip') through a catheter into a larger vein in your body.
Croatian: <Lijek koji sadrži aprotinin> obično ćete dobivati u ležećem položaju, sporom injekcijom ili infuzijom (kroz ‘drip') kroz kateter u veliku venu u tijelu.
English: 4.9 Overdose There is no specific antidote.
Croatian: Ne postoji poseban antidot.
English: If you have any further questions, ask the doctor/surgeon giving you <Aprotinin-containing medicinal product>.
Croatian: Ako imate dodatnih pitanja, obratite se svom liječniku/kirurgu koji Vam daje <lijek koji sadrži aprotinin>.
English: Talk to your doctor before receiving <Aprotinin-containing medicinal product>.
Croatian: Razgovarajte s Vašim liječnikom prije nego što primite <lijek koji sadrži aprotinin>.
English: Fertility There are no adequate and well-controlled studies addressing fertility in men or women.
Croatian: Nema odgovarajućih podataka niti dobro kontroliranih ispitivanja koja se bave plodnošću u muškaraca i žena.
English: A retrospective review suggests that the incidence of severe anaphylactic reactions to aprotinin may further increase when patients are re-exposed more than twice within 6 months.
Croatian: Jedan retrospektivni pregled pokazao je da se incidencija teških anafilaktičkih reakcija na aprotinin može dalje povećavati kad mu se bolesnici izlože više od dvaput unutar 6 mjeseci.
English: There is no special dose recommendation for elderly patients or patients with poor kidney function
Croatian: Nema posebnih preporuka za doziranje kod starijih bolesnika ili bolesnika sa slabom funkcijom bubrega.
English: 6.5 Nature and contents of container [To be completed nationally]
Croatian: 6.5 Vrsta i sadržaj spremnika [Ispunjava država članica]
English: A standard loading dose of heparin, administered prior to cannulation of the heart, plus the quantity of heparin added to the prime volume of the cardiopulmonary bypass circuit, should total at least 350 IU/kg.
Croatian: Standardna udarna doza heparina primijenjena prije kanulacije srca plus količina heparina dodanog u volumen otopine za pokretanje stroja za izvantjelesni krvotok treba ukupno iznositi najmanje 350 IU/kg.
English: Heparin levels during bypass should not be allowed to drop below 2.7 U/ml (2.0 mg/kg) or below the level indicated by heparin dose-response testing performed prior to administration of aprotinin.
Croatian: Ne smije se dopustiti da razine heparina tijekom kardiopulmonalnog premoštenja padnu na vrijednost ispod 2,7 U/ml (2,0 mg/kg) ili ispod razine određene testiranjem odgovora na dozu heparina provedenog prije primjene aprotinina.
English: After the uneventful administration of the 1 ml test dose, the therapeutic dose may be given.
Croatian: Nakon što primjena probne doze od 1 ml prođe mirno, može se dati terapijska doza.
English: A publication by Fergusson et al 2008 analyzed data from a randomized controlled trial, Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), and reported a higher mortality rate in aprotinin-treated patients compared to those treated with tranexamic acid or aminocaproic acid.
Croatian: U objavljenom radu Fergussona i sur. iz 2008 analizirani su podaci iz randomiziranog kontroliranog ispitivanja Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), a zabilježna povećana stopa smrtnosti u bolesnika liječenih aprotininom u usporedbi s onima liječenima traneksamičnom kiselinom ili aminokaproičnom kiselinom.
English: The test is further influenced by variable dilution effects and the temperature experienced during cardiopulmonary bypass.
Croatian: Na test nadalje utječu različiti učinci razrjeđenja i temperature tijekom kardiopulmonalnog premoštenja.
English: By forming reversible stoichiometric enzyme-inhibitor complexes, aprotinin acts as an inhibitor of human trypsin, plasmin, plasma kallikrein and tissue kallikrein, thus inhibiting fibrinolysis.
Croatian: Stvaranjem reverzibilnih stehiometrijskih kompleksa enzima i inhibitora, aprotinin djeluje kao inhibitor ljudskog tripsina, plazmina, plazmatskog kalikreina i tkivnog kalikreina te tako inhibira fibrinolizu.
English: The adverse reactions should be interpreted within the surgical setting.
Croatian: Nuspojave treba tumačiti u kirurškom kontekstu.
English: In-hospital Mortality in a pool of Randomized Clinical Trials (Population: All Global CABG Patients Valid for Safety)
Croatian: Bolnička smrtnost u objedninjenim randomiziranim kliničkim ispitivanjima (populacija: globalno svi bolesnici s ugradnjom aortokoronarne premosnice (CABG) valjani za sigurnost)
English: Aminoglycosides are a risk factor for renal dysfunction.
Croatian: Aminoglikozidi su čimbenici rizika za poremećaj funkcije bubrega.
English: Medicines used to prevent the symptoms of allergy (H1-antagonist and a H2-antagonist) may be administered 15 minutes prior to the test dose of <Aprotinin-containing medicinal product>.
Croatian: Lijekovi koji se primjenjuju za sprječavanje simptoma alergije (H1-antagonist i a H2-antagonist) mogu se primijeniti 15 minuta prije probne doze <lijeka koji sadrži aprotinin>.
English: In patients undergoing cardiopulmonary bypass with aprotinin therapy, one of three methods is recommended to maintain adequate anticoagulation: Activated Clotting Time (ACT), Fixed Heparin Dosing, or Heparin Titration (see below).
Croatian: U bolesnika pri kardiopulmonalnom premoštenju uz terapiju aprotininom preporučuje se jedna od tri metode za održavanje odgovarajuće antikoagulacije: aktivirano vrijeme zgrušavanja (ACT), fiksna doza heparina ili titracija heparina (vidjeti niže).
English: Additional note on use with extracorporeal circulation In patients undergoing cardiopulmonary bypass with aprotinin therapy, one of the following methods is recommended to maintain adequate anticoagulation:
Croatian: Dodatna napomena o primjeni uz izvantjelesni krvotok U bolesnika u kojih se koristi kardiopulmonalno premoštenje uz terapiju aprotininom preporučuje se jedna od sljedećih metoda za održavanje odgovarajuće antikoagulacije:
English: Careful consideration of the balance of risks and benefits is therefore advised before administration of aprotinin to patients with pre-existing impaired renal function or those with risk factors (such as concomitant treatment with aminoglycosides).
Croatian: Stoga se savjetuje pažljivo razmatranje ravnoteže rizika i koristi prije primjene aprotinina bolesnicima s već postojećim oštećenjem funkcije bubega ili onima s čimbenicima rizika (kao što je istovremeno liječenje aminoglikozidima).
English: The test dose of aprotinin should only be administered when facilities and equipment for handling acute anaphylactic reactions are available on-site.
Croatian: Probna doza aprotinina smije se primijeniti samo kad su na mjestu dostupna sredstva i oprema za zbrinjavanje akutnih anafilaktičkih reakcija.
English: Tell your doctor if any of these apply to you, to help him or her decide if <Aprotinin-containing medicinal product> is suitable for you:
Croatian: Obavijestite svog liječnika ako se išta od navedenog odnosi na Vas, kako biste mu pomogli da odluči je li <lijek koji sadrži aprotinin> pogodan za Vas:
English: In any case standard emergency treatments for anaphylactic and allergic reactions should be readily available (see section 4.4).
Croatian: U svakom slučaju, potrebno je imati na raspolaganju spremno standardno hitno liječenje za anafilaktičke i alergijske reakcije (vidjeti dio 4.4).
English: It has been observed that kaolin-based ACTs are not increased to the same degree by aprotinin as are diatomaceous earth-based (celite) ACTs.
Croatian: Opaženo je da aprotinin ne povisuje ACT pomoću kaolina u istom stupnju kao ACT pomoću dijatomejske zemlje (celita).
English: No pharmacokinetic studies are available in patients with terminal renal insufficiency.
Croatian: Nema dostupnih farmakokinetičkih ispitivanja u bolesnika s terminalnom insuficijencijom bubrega.
English: Your doctor/surgeon has decided that you would benefit from <Aprotinin-containing medicinal product> treatment because you are at increased risk of major blood loss since you will undergo a heart bypass operation using a circulation outside your body (heart-lung machine).
Croatian: Liječnik/kirurg je odlučio da ćete imati koristi od liječenja <lijekom koji sadrži aprotinin> zato što imate povećan rizik od velikog gubitka krvi, budući da ćete ići na operaciju ugradnje premosnice pomoću izvantjelesnog krvotoka (stroj srce-pluća).
English: The aprotinin molecule is metabolised to shorter peptides or amino acids by lysosomal activity in the kidney.
Croatian: Molekula aprotinina metabolizira se u kraće peptide ili aminokiseline lizosomskim djelovanjem u bubrezima.
English: There is no specific substance to counteract the effects of <Aprotinin-containing medicinal product>.
Croatian: Ne postoji posebna tvar za poništavanje učinaka <lijeka koji sadrži aprotinin>.
English: When using a multi-lumen central catheter a separate catheter is not required.
Croatian: Kad se koristi višelumenski centralni kateter, nije potreban zasebni kateter.
English: A trend of increased incidence of MI in association with aprotinin was observed in some studies, while other studies showed a lower incidence compared to placebo.
Croatian: U nekim je ispitivanjima bio opažen trend povećanja incidencije infarkta miokarda povezanog s aprotininom, dok su druga ispitivanja pokazala nižu incidenciju u usporedbi s placebom.
English: Your doctor will administer aprotinin after careful consideration of the benefits and risks, and the availability of alternative treatments.
Croatian: Liječnik će Vam dati aprotinin nakon pažljivog razmatranja koristi i rizika te dostupnosti drugih načina liječenja.
English: What <Aprotinin-containing medicinal product> is and what it is used for
Croatian: Što je <lijek koji sadrži aprotinin> i za što se koristi