FrancophonIA/ELRC3.0 huggingface dataset:
English: CEPROTIN is indicated in purpura fulminans and coumarin induced skin necrosis in patients with severe congenital protein C deficiency.
Croatian: CEPROTIN je indiciran kod purpure fulminans i kumarinom inducirane nekroze kože u bolesnika s teškim prirođenim nedostatkom proteina C.
English: 10 ml Sterilised Water for Injections
Croatian: 10 ml sterilizirane vode za injekcije
English: The protein C plasma activity was measured by chromogenic assay.
Croatian: Aktivnost proteina C mjerena je pomoću kromogenog testa.
English: Concurrent anticoagulant medication (such as heparin) may have been responsible for these bleeding episodes.
Croatian: Za ove epizode krvarenja može biti odgovorna istovremena antikoagulantna terapija (poput heparina).
English: CEPROTIN will be administered to you by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
Croatian: CEPROTIN će Vam se primijeniti intravenskom injekcijom nakon pripreme praška za otopinu za injekciju sa steriliziranom vodom za injekcije.
English: Sodium chloride: 44 mg/vial Sodium citrate.
Croatian: Pomoćne tvari s poznatim učinkom: Natrijev klorid: 44 mg/bočica Natrijev citrat.
English: If you receive prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention).
Croatian: Ako profilaktički primate protein C, mogu biti potrebne više početne doze u slučajevima povećanog rizika tromboze (kao što su infekcija, trauma ili kirurški zahvat).
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Unatoč svim tim mjerama, pri primjeni lijekova pripravljenih od ljudske krvi ili plazme, ne može se posve isključiti mogućnost prijenosa infektivnih uzročnika.
English: As with any intravenous product allergic type hypersensitivity reactions are possible.
Croatian: Kao i kod svakog intravenskog lijeka moguće su reakcije preosjetljivosti alergijskog tipa.
English: APC is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. APC exerts its effect by the inactivation of the activated forms of factors V and VIII which leads to a decrease in thrombin formation.
Croatian: APC postiže svoj učinak inaktivacijom aktiviranih oblika faktora V i VIII što dovodi do smanjenja formiranja trombina.
English: In patients receiving prophylactic administration of protein C, higher trough levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention).
Croatian: Kod bolesnika u kojih se profilaktički primjenjuje protein C mogu biti potrebne više početne doze u slučajevima povećanog rizika od tromboze (kao što su infekcija, trauma ili kirurški zahvat).
English: Protein C is a vitamin K-dependent anticoagulant glycoprotein which is synthesised in the liver.
Croatian: K ovisan antikoagulantni glikoprotein koji se sintetizira u jetri.
English: CEPROTIN is administered by intravenous injection after reconstitution of the powder for solution for injection with Sterilised Water for Injections.
Croatian: CEPROTIN se primjenjuje intravenskom injekcijom nakon rekonstitucije praška za otopinu za injekciju sa steriliziranom vodom za injekcije.
English: You may notice any of the following side effects after administration of CEPROTIN:
Croatian: Nakon primjene lijeka CEPROTIN možete primijetiti neku od sljedećih nuspojava:
English: Baxter AG A-1221 Vienna, Austria
Croatian: Baxter AG A-1221 Beč, Austrija
English: System Organ Class Adverse Reaction
Croatian: Klasifikacija organskih sustava
English: The dose, administration frequency and duration of treatment depend on the severity of the protein C deficiency as well as on your clinical condition and on your plasma level of protein C. They should be adjusted accordingly on the basis of clinical effectiveness and laboratory assessment.
Croatian: Doziranje, učestalost primjene i trajanje liječenja ovise o težini nedostatka proteina C kao i o Vašem kliničkom stanju i razini proteina C u plazmi.
English: The intravenous administration of CEPROTIN provides for an immediate but temporary increase in plasma levels of protein C. Replacement of protein C in protein C deficient patients is expected to control or - if given prophylactically - prevent thrombotic complications.
Croatian: Nadomještanje proteina C u bolesnika s nedostatkom proteina C očekuje se da će rezultirati kontroliranjem ili - ako se daje profilaktički - prevencijom trombotskih komplikacija.
English: After reconstitution, the solution is drawn through the sterile filter needle into a sterile disposable syringe.
Croatian: Nakon pripreme, otopina se kroz sterilnu filter iglu uvuče u sterilnu štrcaljku za jednokratnu uporabu.
English: Reconstitute lyophilised CEPROTIN powder for solution for injection, with the supplied solvent (Sterilised Water for Injections) using the sterile transfer needle.
Croatian: Pripremite liofilizirani CEPROTIN prašak za otopinu za injekciju pomoću priloženog otapala (sterilizirana voda za injekcije) koristeći sterilnu iglu za prijenos.
English: CEPROTIN 500 IU powder and solvent for solution for injection
Croatian: CEPROTIN 500 IU prašak i otapalo za otopinu za injekciju
English: CEPROTIN 1000 IU powder and solvent for solution for injection
Croatian: CEPROTIN 1000 IU prašak i otapalo za otopinu za injekciju
English: BAXTER AG Industriestrasse 67 A-1221 Vienna Austria
Croatian: BAXTER AG Industriestrasse 67 A-1221 Beč Austrija
English: Patients with renal and/or hepatic impairment should be monitored more closely.
Croatian: Bolesnike s bubrežnim i/ili jetrenim oštećenjem potrebno je pažljivije pratiti (vidjeti dio 4.4).
English: Solvent Sterilised Water for Injections
Croatian: Otapalo sterilizirana voda za injekcije
English: The solution is drawn through the sterile filter needle into a sterile disposable syringe.
Croatian: Otopina se kroz sterilnu filter iglu uvuče u sterilnu štrcaljku za jednokratnu uporabu.
English: Powder and solvent for solution for injection Human Protein C
Croatian: Prašak i otapalo za otopinu za injekciju humani protein C
English: Sterilised Water for Injections is used.
Croatian: Kao otapalo koristi se sterilizirana voda za injekcije.
English: You should be aware of the early signs of allergic reactions such as burning and stinging at the injection site, chills, flushing, rash, hives, breathing difficulty, nausea, headache, lethargy, low blood pressure, and tightness of the chest.
Croatian: Trebate znati prepoznati rane znakove alergijskih reakcija kao što su pečenje i žarenje na mjestu primjene injekcije, zimica, navale crvenila, osip, koprivnjača, teškoće s disanjem, mučnina, glavobolja, letargija, nizak krvni tlak i stezanje u prsima.
English: Patients should be informed of the early signs of hypersensitivity reactions, which may include angioedema, burning and stinging at the injection site, chills, flushing, rash, pruritus, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, and wheezing.
Croatian: Bolesnike treba informirati o ranim znakovima reakcija preosjetljivosti koje mogu uključivati angioedem, peckanje i žarenje na mjestu injekcije, zimicu, crvenilo, osip, svrbež, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsima, trnce, povraćanje i piskanje.
English: A separate unused filter needle must be used to withdraw each vial of reconstituted CEPROTIN.
Croatian: Za izvlačenje svake bočice pripremljenog lijeka CEPROTIN mora se koristiti zasebna nekorištena filter igla.
English: The solvent comes in vials of neutral glass of hydrolytic type I. The product and the solvent vials are closed with butyl rubber stoppers.
Croatian: Otapalo se nalazi u bočicama s neutralnim staklom hidrolitičkog tipa I.
English: The measurement of protein C activity using chromogenic substrates is recommended for the determination of the patient's plasma level for protein C before and during treatment with CEPROTIN.
Croatian: Za određivanje razine proteina C u plazmi bolesnika prije i tijekom liječenja lijekom CEPROTIN preporučuje se mjerenje aktivnosti proteina C korištenjem kromogenog supstrata.
English: The measurement of protein C activity using chromogenic substrates is recommended for the determination of your plasma level for protein C before and during treatment with CEPROTIN.
Croatian: Za određivanje razine proteina C u plazmi prije i tijekom liječenja lijekom CEPROTIN preporučuje se mjerenje aktivnosti proteina C korištenjem kromogenog supstrata.
English: Sodium chloride: 88 mg/vial Sodium citrate.
Croatian: Pomoćne tvari s poznatim učinkom: Natrijev klorid: 88 mg/bočica
English: CEPROTIN 1000 IU powder and solvent for solution for injection Human Protein C
Croatian: CEPROTIN 1000 IU prašak i otapalo za otopinu za injekciju humani protein C
English: Protein C contained in CEPROTIN is a normal constituent of human plasma and acts like endogenous protein C. Therefore experimental studies on tumorigenic or mutagenic effects - particularly in heterologous species - are not considered necessary.
Croatian: Protein C koji se nalazi u lijeku CEPROTIN je normalan sastojak ljudske plazme i djeluje kao endogeni protein C.
English: CEPROTIN 500 IU powder and solvent for solution for injection Human Protein C
Croatian: CEPROTIN 500 IU prašak i otapalo za otopinu za injekciju humani protein C
English: You should not do both.
Croatian: Ne biste smjeli raditi oboje.
English: Both compounds bind mainly to albumin.
Croatian: Oba spoja prvenstveno se vežu za albumin.
English: • you are more than 75 years old,
Croatian: • ako imate više od 75 godina,
English: The following risks:
Croatian: Sljedeći rizici:
English: 3 years.
Croatian: 6 mjeseci.
English: Lactose is a type of sugar.
Croatian: Laktoza je jedna vrsta šećera.
English: The tablet cannot be divided into equal doses.
Croatian: Tableta se ne može razdijeliti na jednake doze.
English: This effect is considered specific to this species and not relevant to humans.
Croatian: Taj se učinak smatra specifičnim za tu vrstu i nije značajan za ljude.
English: Contact immediately your doctor or the nearest emergency department or hospital.
Croatian: Odmah se obratite liječniku ili najbližoj hitnoj službi ili bolnici.
English: Do not drink grapefruit juice while taking MULTAQ.
Croatian: Nemojte piti sok od grejpa dok uzimate MULTAQ.
English: It is recommended to perform ECGs serially, at least every 6 months.
Croatian: Preporučuje se serijski provoditi EKG, najmanje svakih 6 mjeseci.
English: MULTAQ and some other medicines can affect each other and cause serious side effects.
Croatian: MULTAQ i neki drugi lijekovi mogu utjecati jedni na druge i tako prouzročiti ozbiljne nuspojave.
English: In ATHENA study, the maximum follow-up was 30 months.
Croatian: U ispitivanju ATHENA maksimalno vrijeme praćenja bilo je 30 mjeseci.
English: Statins should be used with caution.
Croatian: Statine treba primjenjivati uz oprez.
English: • losing your sense of taste,
Croatian: • gubitak osjeta okusa,
English: Your heart might beat very slowly or you may feel dizzy.
Croatian: U tom slučaju srce Vam može kucati vrlo sporo ili možete osjećati omaglicu.
English: MULTAQ is used only in adults.
Croatian: MULTAQ se primjenjuje samo u odraslih osoba.
English: If any of the above apply to you, do not take MULTAQ.
Croatian: Ako se nešto od navedenog odnosi na Vas, nemojte uzimati MULTAQ.
English: • Your doctor may also do other blood tests.
Croatian: • Vaš liječnik može provesti i neke druge krvne pretrage.
English: Due to its safety profile (see sections 4.3 and 4.4), MULTAQ should only be prescribed after alternative treatment options have been considered.
Croatian: S obzirom na njegov sigurnosni profil (vidjeti dio 4.3 i 4.4), MULTAQ se smije propisati tek nakon što se razmotre alternativne mogućnosti liječenja.
English: • your skin being more sensitive to the sun,
Croatian: • pojačana osjetljivost kože na sunce,
English: Date of first authorisation: 26 November 2009 Date of latest renewal:
Croatian: Datum prvog odobrenja: 26. studenoga 2009.
English: Your doctor may change the dose of any other medicines you are taking.
Croatian: Liječnik će možda promijeniti dozu nekog drugog lijeka koji uzimate.
English: • Allergic reactions, including swelling of the face, lips, mouth, tongue or throat.
Croatian: • Alergijske reakcije, uključujući oticanje lica, usana, usta, jezika ili grla.
English: The primary endpoint of the study was the time to first hospitalisation for cardiovascular reasons or death from any cause.
Croatian: Primarna mjera ishoda ispitivanja bilo je vrijeme do prve hospitalizacije zbog kardiovaskularnih razloga ili smrti zbog bilo kojeg uzroka.
English: MULTAQ with food and drink
Croatian: MULTAQ s hranom i pićem
English: The content and format of the MULTAQ Prescriber guide, together with the communication and distribution plan should be agreed with the National Competent Authority in each Member State prior to distribution.
Croatian: Sadržaj i format Vodiča za liječnike propisivače lijeka MULTAQ, zajedno s planom komunikacije i distribucije, treba dogovoriti s nadležnim tijelom pojedine države članice prije distribucije.
English: These changes are linked to the therapeutic effect of dronedarone and do not reflect toxicity.
Croatian: Te su promjene povezane s terapijskim učinkom dronedarona i ne odražavaju toksičnost.
English: It non-competitively antagonises adrenergic activities (Class II).
Croatian: Nekompetitivno antagonizira adrenergička djelovanja (skupina II).
English: What you need to know before you take MULTAQ
Croatian: Što morate znati prije nego počnete uzimati MULTAQ
English: Children and adolescents MULTAQ is not recommended in children and adolescents below 18 years of age.
Croatian: MULTAQ se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: • Stop taking your tablets and talk to your doctor straight away if you get pregnant while taking
Croatian: • Prestanite uzimati tablete i odmah se obratite liječniku ako zatrudnite dok uzimate MULTAQ.
English: Tell your doctor about all the medicines you take.
Croatian: Obavijestite svog liječnika o svim lijekovima koje uzimate.
English: It should be considered that amiodarone may have a long duration of action after discontinuation due to its long half-life.
Croatian: Treba uzeti u obzir da amiodaron može imati dugotrajnu aktivnost nakon prestanka primjene zbog dugog poluvijeka.
English: The mean exposure across studies was 13 months.
Croatian: Prosječna izloženost u svim ispitivanjima iznosila je 13 mjeseci.
English: Efficacy and safety were comparable in elderly patients who did not suffer from other cardiovascular diseases and younger patients.
Croatian: Djelotvornost i sigurnost primjene u starijih bolesnika koji nisu bolovali od drugih kardiovaskularnih bolesti bile su slične onima u mlađih bolesnika.
English: • Your doctor may check your lungs.
Croatian: • Liječnik može kontrolirati Vaša pluća.
English: What MULTAQ is and what it is used for
Croatian: Što je MULTAQ i za što se koristi
English: These effects most likely result from its electrophysiological properties belonging to all four Vaughan-Williams classes.
Croatian: Ti su učinci najvjerojatnije posljedica elektrofizioloških svojstava lijeka, koja pripadaju svim četirima skupinama po Vaughan-Williamsovoj klasifikaciji.
English: There was no increased risk of hypotension, bradycardia and heart failure.
Croatian: Nije bilo povećanog rizika od hipotenzije, bradikardije i zatajenja srca.
English: If you take more MULTAQ than you should
Croatian: Ako uzmete više lijeka MULTAQ nego što ste trebali
English: • Do not take MULTAQ if you are a woman able to have children and you are not using a reliable contraceptive method.
Croatian: • Nemojte uzimati MULTAQ ako ste žena koja može zatrudnjeti, a ne koristite pouzdanu metodu kontracepcije.
English: In most patients this increase occurs early after treatment initiation and reaches a plateau after 7 days.
Croatian: U većine bolesnika to povišenje nastupa ubrzo nakon početka liječenja, a plato se postiže nakon 7 dana.
English: AF recurrence was 63.5% versus 42%, respectively.
Croatian: Recidiv FA iznosio je 63,5% naspram 42%.
English: If a dose is missed, patients should take the next dose at the regular scheduled time and should not double the dose.
Croatian: Ako bolesnik propusti uzeti dozu lijeka, sljedeću dozu mora uzeti u planirano vrijeme, a doza se ne smije udvostručiti.
English: Each of these factors has a limited influence on dronedarone.
Croatian: Svaki od navedenih faktora ima ograničeni utjecaj na dronedaron.
English: The safety and efficacy of MULTAQ in children aged below 18 years of age have not yet been established.
Croatian: Sigurnost primjene i djelotvornost lijeka MULTAQ u djece mlađe od 18 godina još nisu ustanovljene.
English: You must tell your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Morate obavijestiti svog liječnika ili ljekarnika ako uzimate neki od sljedećih lijekova:
English: Gender, age and weight are factors that influence the pharmacokinetics of dronedarone.
Croatian: Spol, dob i tjelesna težina su faktori koji utječu na farmakokinetiku dronedarona.
English: If an increase in creatininaemia is observed, serum creatinine should be re-measured after a further 7 days.
Croatian: Ako se primijeti povećana kreatininemija, kreatinin u serumu treba ponovno izmjeriti nakon dodatnih 7 dana.
English: Your doctor will consider all available treatment options before prescribing MULTAQ to you.
Croatian: Vaš liječnik će razmotriti sve dostupne opcije liječenja prije propisivanja lijeka MULTAQ.
English: Take:
Croatian: Uzmite:
English: Electrolytes imbalance
Croatian: Neravnoteža elektrolita
English: It reduces alpha-adrenergic blood pressure response to epinephrine and beta1 and beta2 responses to isoproterenol.
Croatian: Smanjuje alfa-adrenergički odgovor krvnog tlaka na epinefrin te beta1 i beta2 odgovor na izoproterenol.
English: Also contains: lactose.
Croatian: Također sadrži: laktozu.
English: You should stop taking MULTAQ,
Croatian: Morate prestati uzimati MULTAQ,
English: It belongs to a group of medicines called anti-arrhythmics that help regulate your heart beat.
Croatian: Pripada skupini lijekova koji se nazivaju antiaritmicima, a pomažu u reguliranju otkucaja srca.
English: In some cases, MULTAQ treatment may need to be stopped.
Croatian: U nekim će slučajevima liječenje lijekom MULTAQ možda trebati prekinuti.
English: Treatment with MULTAQ will be overseen by a doctor who is experienced in the treatment of heart disease.
Croatian: Liječenje lijekom MULTAQ nadgledat će liječnik koji ima iskustva u liječenju bolesti srca.
English: • some medicines for depression called tricyclic antidepressants,
Croatian: • neke lijekove za liječenje depresije koji se zovu triciklički antidepresivi,
English: Other medicines and MULTAQ
Croatian: Drugi lijekovi i MULTAQ
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from MULTAQ therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom MULTAQ uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: This problem should be corrected before starting treatment with MULTAQ,
Croatian: To treba ispraviti prije početka liječenja lijekom MULTAQ,
English: Patients with coronary artery disease
Croatian: Bolesnici s bolešću koronarnih arterija
English: Liver function tests should be performed prior to initiation of treatment with dronedarone, after one week and after one month following initiation of treatment and then repeated monthly for six months, at months 9 and 12, and periodically thereafter.
Croatian: Testove jetrene funkcije treba provesti prije početka liječenja dronedaronom, tjedan dana nakon početka liječenja, mjesec dana nakon početka liječenja te zatim jednom mjesečno tijekom šest mjeseci, u 9. i 12. mjesecu liječenja te povremeno nakon toga.
English: Do not use this medicine if you notice any visible sign of deterioration (see section 6).
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive znakove kvarenja (vidjeti dio 6).
English: • you have a problem that gives you a low level of potassium or magnesium in your blood.
Croatian: • ako imate problem zbog kojeg su Vam snižene razine kalija ili magnezija u krvi.
English: • rifampicin - for tuberculosis.
Croatian: • rifampicin - za liječenje tuberkuloze.
English: Cardiac disorders Congestive heart failure (see below)
Croatian: Srčani poremećaji kongestivno zatajenje srca (vidjeti ispod)
English: • you have breathlessness or non-productive cough.
Croatian: • ako imate nedostatak zraka ili neproduktivan kašalj.
English: Dronedarone decreases arterial blood pressure and myocardial contractility (dP/dt max) with no change in left ventricular ejection fraction and reduces myocardial oxygen consumption.
Croatian: Dronedaron snižava arterijski krvni tlak i kontraktilnost miokarda (dP/dt max) bez promjene ejekcijske frakcije lijeve klijetke i smanjuje potrošnju kisika u miokardu.
English: • Your doctor may look at your heart's electrical activity using an ECG (electrocardiogram)
Croatian: • Liječnik može provjeriti električnu aktivnost srca uređajem za EKG (elektrokardiogram).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: 4.7 Effects on ability to drive and use machines MULTAQ has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima MULTAQ nema ili ima zanemariv utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: It is not known whether dronedarone and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).
Croatian: Nije poznato mogu li se dronedaron i/ili njegovi metaboliti odstraniti dijalizom (hemodijalizom, peritonejskom dijalizom ili hemofiltracijom).
English: The terminal elimination half-life of dronedarone is around 25-30 hours and that of its N-debutyl metabolite around 20-25 hours.
Croatian: Terminalno poluvrijeme eliminacije dronedarona iznosi približno 25-30 sati, a N-debutil metabolita približno 20-25 sati.
English: Management of plasma creatinine increase
Croatian: Liječenje povišene razine kreatinina u plazmi
English: There is no specific antidote available.
Croatian: Nema specifičnog protulijeka.
English: • one tablet with the morning meal and
Croatian: • jednu tabletu uz jutarnji obrok i
English: The in vitro plasma protein binding of dronedarone and its N-debutyl metabolite is 99.7% and 98.5% respectively and is not saturable.
Croatian: In vitro vezanje dronedarona i njegova N-debutil metabolita za proteine plazme iznosi 99,7%, odnosno 98,5% i nije zasićeno.
English: An increase in creatininaemia should not necessarily lead to the discontinuation of treatment with ACE inhibitors or Angiotensin II Receptors Antagonists (AIIRAs).
Croatian: Povećanje kreatininemije ne mora nužno dovesti do prekida liječenja ACE inhibitorima ili antagonistima receptora angiotenzina II.
English: • cisapride (a medicine for food and acid reflux from your stomach to your mouth),
Croatian: • cisaprid (lijek za refluks hrane i kiseline iz želuca u usta),
English: • telithromycin, erythromycin, or clarithromycin (antibiotics for infections),
Croatian: • telitromicin, eritromicin ili klaritromicin (antibiotike za liječenje infekcija),