FrancophonIA/ELRC3.0 huggingface dataset:
English: Pradaxa (220 or 150 mg a day) was as effective as enoxaparin (an anticoagulant given by injection) in preventing formation of blood clots or death in patients who had undergone hip or knee replacement in two main studies.
Croatian: U dva glavna ispitivanja lijek Pradaxa (u dozi od 220 ili 150 mg na dan) bio je jednako učinkovit kao i enoksaparin (antikoagulans koji se daje injekcijom) u pogledu sprječavanja nastanka krvnih ugrušaka ili smrti u bolesnika kojima je prethodno zamijenjen kuk ili koljeno.
English: • preventing the formation of blood clots in the veins in adults who have had an operation to replace a hip or knee;
Croatian: • sprječavanje stvaranja krvnih ugrušaka u venama u odraslih osoba nakon kirurškog zahvata zamjene kuka ili koljena
English: The proportion of patients who had a stroke or other problems caused by blood clots each year was around 1.5% for patients taking 110 mg Pradaxa (183 patients out of 6,015) and 1.1% for patients taking 150 mg Pradaxa (135 out of 6,076), compared with 1.7% for patients taking warfarin (203 out of 6,022).
Croatian: Udio bolesnika koji su imali moždani udar ili druge probleme prouzročene krvnim ugrušcima svake godine bio je oko 1,5 % u bolesnika koji su primali lijek Pradaxa u dozi od 110 mg (183 od 6 015 bolesnika), u usporedbi s 1,7 % u bolesnika koji su primali varfarin (203 od 6 022 bolesnika).
English: Blood clots or blood-clot-related death occurred in 2.7% (68 out of 2,553) of patients treated with Pradaxa, compared with 2.4% (62 out of 2,554) of patients treated with warfarin.
Croatian: Krvni ugrušci ili smrt povezana s krvnim ugrušcima zabilježeni su u 2,7 % (68 od 2 553) bolesnika koji su primali lijek Pradaxa, u usporedbi s 2,4% (62 od 2 554) bolesnika liječenih varfarinom.
English: In the second study, blood clots or blood-clot-related death occurred in 0.4% (3 out of 681) of patients treated with Pradaxa, compared with 5.6% (37 out of 662) of patients treated with placebo.
Croatian: U drugom ispitivanju krvni ugrušci ili smrt povezana s krvnim ugrušcima zabilježeni su u 0,4 % (3 od 681) bolesnika koji su primali lijek Pradaxa, u usporedbi s 5,6% (37 od 662) bolesnika koji su primali placebo.
English: In the first study, blood clots or blood-clot-related death occurred in 1.8% (26 out of 1,430) of patients treated with Pradaxa, compared with 1.3% (18 out of 1,426) of patients treated with warfarin.
Croatian: U prvom ispitivanju krvni ugrušci ili smrt povezana s krvnim ugrušcima zabilježeni su u 1,8 % (26 od 1 430) bolesnika koji su primali lijek Pradaxa, u usporedbi s 1,3 % (18 od 1 426) bolesnika liječenih varfarinom.
English: During the treatment period, blood clots were detected in 6% of the patients taking 220 mg Pradaxa (53 out of 880), compared with 7% of the patients receiving enoxaparin (60 out of 897).
Croatian: Tijekom liječenja krvni ugrušci pronađeni su u 6 % (53 od 880) bolesnika koji su primali lijek Pradaxa u dozi od 220 mg, u usporedbi sa 7 % (60 od 897) bolesnika koji su primali enoksaparin.
English: Pradaxa (110 mg or 150 mg twice a day) was as effective as warfarin (another anticoagulant given by mouth) in preventing stroke or a blood clot blocking blood vessels in other parts of the body in a study of patients with non-valvular atrial fibrillation who were considered to be at risk of stroke.
Croatian: U ispitivanju provedenom među bolesnicima s nevalvularnom fibrilacijom atrija za koje se pretpostavljalo da su izloženi riziku od moždanog udara, lijek Pradaxa (u dozi od 110 mg ili 150 mg dvaput na dan) bio je jednako učinkovit kao i varfarin (drugi antikoagulans koji se daje kroz usta) u pogledu sprječavanja moždanog udara ili nastanka krvnih ugrušaka koji mogu začepiti krvne žile u drugim dijelovima tijela.
English: During the treatment period, blood clots were detected in 36% of the patients taking 220 mg Pradaxa (183 out of 503), compared with 38% of the patients receiving enoxaparin (193 out of 512).
Croatian: Tijekom liječenja krvni ugrušci pronađeni su u 36 % (183 od 503) bolesnika koji su primali lijek Pradaxa u dozi od 220 mg, u usporedbi s 38 % (193 od 512) bolesnika koji su primali enoksaparin.
English: Two main studies in over 5,100 adults with symptoms of DVT or PE, and who were initially treated with an injectable anticoagulant, compared Pradaxa with warfarin.
Croatian: Lijek Pradaxa uspoređen je s varfarinom u dva glavna ispitivanja na 5 100 odraslih osoba sa simptomima DVT-a ili PE-a koji su prvobitno bili liječeni antikoagulansom u obliku injekcije.
English: For the full list of all side effects reported with Pradaxa, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Pradaxa potražite u uputi o lijeku.
English: Treatment and prevention of DVT and PE
Croatian: Liječenje i sprječavanje duboke venske tromboze i plućne embolije
English: • evaluation of the left-ventricular ejection fraction (LVEF)
Croatian: • procjena ejekcijske frakcije lijeve klijetke (LVEF)
English: Conditions to the marketing authorisations
Croatian: Uvjeti odobrenja za stavljanje lijeka u promet
English: • life-time maximum dose
Croatian: • najveća dopuštena doza za jedan životni vijek
English: The Marketing Authorisation Holders of Novantrone and associated names shall submit for assessment to the Reference Member State a Risk Management Plan containing key elements as described in the CHMP assessment report.
Croatian: Nositelji odobrenja za stavljanje lijeka Novantrone i srodnih lijekova u promet dostavljaju referentnoj državi članici plan upravljanja rizikom radi njegova ocjenjivanja, a koji sadrži ključne elemente opisane u izvješću o ocjenjivanju CHMP-a.
English: • Novantrone could cause haematotoxicity, including secondary acute myeloid leukaemia and myelodysplastic syndrome o the need for monitoring at the start and prior to each treatment administration
Croatian: • Novantrone može uzrokovati hematotoksičnost, uključujući sekundarnu akutnu mijeloičnu leukemiju i mijelodisplastični sindrom o potreban nadzor na početku i prije svake primjene terapije
English: The Marketing Authorisation Holder(s) shall ensure that in each Member State where Novantrone and associated names are marketed, all healthcare professional (HCP) and patients/carers who are expected to prescribe and dispense or use Novantrone in treatment of multiple sclerosis have access to/are provided with the following educational package:
Croatian: Nositelj(i) odobrenja za stavljanje lijeka u promet osiguravaju da su u svim državama članicama u kojima se lijek Novantrone i srodni lijekovi stavljaju u promet svi zdravstveni djelatnici i bolesnici/njegovatelji za koje se očekuje da će propisivati i dozirati ili primjenjivati lijek Novantrone u liječenju multiple skleroze opremljeni ili imaju pristup sljedećim edukativnim paketima:
English: • Novantrone could cause cardiotoxicity o need for echocardiogram or multiple-gated acquisition (MUGA) evaluation of the left-ventricular ejection fraction (LVEF) prior to administration of each dose and yearly for up to 5 years after the end of therapy.
Croatian: • Novantrone može uzrokovati kardiotoksičnost o potrebna procjena ejekcijske frakcije lijeve klijetke (LVEF) putem ehokardiograma ili ekvilibrijske radionuklidne ventrikulografije (MUGA) prije primjene svake doze te procjena na godišnjoj osnovi do najviše pet godina nakon završetka terapije.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Croatian: Nacionalna nadležna tijela države članice/država članica ili referentne države članice/referentnih država članica, ako je primjenjivo, moraju osigurati da nositelj(i) odobrenja za stavljanje lijeka u promet ispuni/ispune sljedeće uvjete:
English: • full blood count including platelets
Croatian: • cjelokupna krvna slika, uključujući razinu trombocita
English: • signs and symptoms of cardiotoxicity and haematotoxicity
Croatian: • znakovi i simptomi kardiotoksičnosti i hematotoksičnosti
English: • key signs and symptoms regarding cardiotoxicity and haematotoxicity
Croatian: • ključni znakovi i simptomi kardiotoksičnosti i hematotoksičnosti
English: • Information on the need of regular monitoring, and when it should be carried out, for cardiotoxicity and haematotoxicity
Croatian: • informacije o potrebi za redovitim nadzorom radi utvrđivanja moguće kardiotoksičnosti i hematotoksičnosti i informacije o tome kada se provodi to nadzorno praćenje
English: Patient information document including the following key-elements:
Croatian: Informativni dokument za bolesnike koji uključuje sljedeće ključne elemente:
English: Patient alert card including the following key-elements:
Croatian: Kartica s upozorenjima za bolesnike koja uključuje sljedeće ključne elemente:
English: HCP brochure including the following key-elements:
Croatian: Brošura za zdravstvene djelatnike koja uključuje sljedeće ključne elemente:
English: HCP checklist including the following key-elements:
Croatian: Kontrolni popis za zdravstvene djelatnike koji uključuje sljedeće ključne elemente:
English: Each blister contains either 6 or 10 hard capsules.
Croatian: Svaki blister sadrži 6 ili 10 tvrdih kapsula.
English: COPD is a long-term disease and you should use Xoterna Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Croatian: KOPB je dugoročna bolest i trebate primijeniti Xoterna Breezhaler svaki dan, a ne samo kada imate poteškoće s disanjem ili druge simptome KOPB-a.
English: Xoterna Breezhaler is recommended to be administered at the same time of the day each day.
Croatian: Preporučuje se da se Xoterna Breezhaler primjenjuje u isto vrijeme svakoga dana.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Xoterna Breezhaler should any of these signs or symptoms develop.
Croatian: Bolesnike treba obavijestiti o znakovima i simptomima akutnog glaukoma uskog kuta i uputiti ih da prestanu koristiti Xoterna Breezhaler ako se pojavi bilo koji od tih znakova i simptoma.
English: Talk to your doctor, pharmacist or nurse before using Xoterna Breezhaler if any of the following applies to you: - you have asthma - this medicine should not be used as a treatment for asthma.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Xoterna Breezhaler ako se bilo što od navedenoga odnosi na Vas: - ako imate astmu - ovaj lijek se ne smije koristiti za liječenje astme.
English: The recommended dose is the inhalation of the content of one capsule once daily using the Xoterna Breezhaler inhaler.
Croatian: Preporučena doza je inhalacija sadržaja jedne kapsule jedanput na dan korištenjem Xoterna Breezhaler inhalatora.
English: The safety and efficacy of Xoterna Breezhaler in children have not been established.
Croatian: Sigurnost i djelotvornost Xoterna Breezhalera u djece nisu ustanovljeni.
English: There is no relevant use of Xoterna Breezhaler in the paediatric population (under 18 years) in the indication COPD.
Croatian: Nema relevantne primjene Xoterna Breezhalera u pedijatrijskoj populaciji (mlađih od 18 godina) u indikaciji KOPB-a.
English: - When you start a new pack, use the new Xoterna Breezhaler inhaler that is supplied in the pack.
Croatian: - Kada otvorite novo pakiranje, upotrijebite novi Xoterna Breezhaler inhalator koji je priložen u pakiranju.
English: The capsules must be administered only using the Xoterna Breezhaler inhaler (see section 6.6).
Croatian: Kapsule se moraju primjenjivati isključivo korištenjem inhalatora Xoterna Breezhaler (vidjeti dio 6.6).
English: Therefore Xoterna Breezhaler should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.
Croatian: Zbog toga Xoterna Breezhaler ne treba primjenjivati istodobno s beta-adrenergičkim blokatorima (uključujući kapi za oči), osim ako za to ne postoje uvjerljivi razlozi.
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate (see section 2 under “Xoterna Breezhaler contains lactose”).
Croatian: - Drugi sastojci praška inhalata su laktoza hidrat i magnezijev stearat (vidjeti dio 2 ispod „Xoterna Breezhaler sadrži laktozu“).
English: Other most common adverse reactions related to the medicinal product (at least 3% of patients for Xoterna Breezhaler and also greater than placebo) were cough, nasopharyngitis and headache.
Croatian: Druge najčešće nuspojave povezane s lijekom (u najmanje 3% bolesnika za Xoterna Breezhaler i uz to češće nego za placebo) bile su kašalj, nazofaringitis i glavobolja.
English: • Xoterna Breezhaler capsules must always be stored in the blister card and only removed immediately before use.
Croatian: • Xoterna Breezhaler kapsule moraju se uvijek čuvati u blister kartici i izvaditi tek neposredno prije primjene.
English: Overall the effect on heart rate over time did not show a consistent pharmacodynamic effect of Xoterna Breezhaler.
Croatian: Sveukupno, učinak na srčanu frekvenciju tijekom vremena nije pokazao dosljedan farmakodinamički učinak Xoterna Breezhalera.
English: Xoterna Breezhaler should not be used for the treatment of asthma due to the absence of data in this indication.
Croatian: Astma Xoterna Breezhaler ne smije se koristiti za liječenje astme zbog nedostatka podataka u ovoj indikaciji.
English: The effect was significantly greater for Xoterna Breezhaler, when compared to indacaterol, glycopyrronium or tiotropium alone (difference 110 ml, for each comparison).
Croatian: Učinak je bio značajno veći za Xoterna Breezhaler kada se uspoređuje sa samim indakaterolom, glikopironijem ili tiotropijem (razlika 110 ml, za svaku usporedbu).
English: Xoterna Breezhaler, dosed in the morning, reduced dynamic hyperinflation and improved the length of time exercise could be maintained from the first dose onwards.
Croatian: Xoterna Breezhaler, primijenjen ujutro, smanjio je dinamičku hiperinflaciju i povećao vrijeme tijekom kojeg se može održavati napor od prve doze nadalje.
English: Xoterna Breezhaler should be used with caution in these patient groups.
Croatian: Xoterna Breezhaler treba koristiti s oprezom u tih skupina bolesnika.
English: Therefore, Xoterna Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.
Croatian: Stoga se Xoterna Breezhaler smije koristiti tijekom trudnoće samo ako očekivana korist za bolesnika opravdava potencijalni rizik za fetus.
English: The use of Xoterna Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant (see section 5.3).
Croatian: Primjenu Xoterna Breezhalera u dojilja treba uzeti u obzir samo ako je očekivana korist za ženu veća od bilo kojeg mogućeg rizika za dojenče (vidjeti dio 5.3).
English: Xoterna Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).
Croatian: Xoterna Breezhaler se može koristiti u preporučenoj dozi u starijih bolesnika (u dobi od 75 i više godina).
English: You should not use Xoterna Breezhaler unless your doctor tells you to do so.
Croatian: Nemojte koristiti Xoterna Breezhaler osim ako Vam to nije rekao liječnik.
English: There was no evidence for tachyphylaxis to the effect of Xoterna Breezhaler over time when compared to placebo or its monotherapy components.
Croatian: Nije bilo dokaza tahifilaksije na učinak Xoterna Breezhalera tijekom vremena u usporedbi s placebom ili monoterapijama njegovim komponentama.
English: When indacaterol and glycopyrronium are administered together in Xoterna Breezhaler, they provide additive efficacy due to their different mode of action targeting different receptors and pathways to achieve smooth muscle relaxation.
Croatian: Kada se indakaterol i glikopironij primjenjuju zajedno u Xoterna Breezhaleru, pružaju dodatnu djelotvornost zbog svog različitog mehanizma djelovanja koji je usmjeren na različite receptore i puteve da bi se postiglo opuštanje glatkih mišića.
English: Following inhalation of Xoterna Breezhaler, the absolute bioavailability of indacaterol has been estimated to range from 61 to 85% of the delivered dose, and that of glycopyrronium was about 47% of the delivered dose.
Croatian: Nakon inhalacije Xoterna Breezhalera apsolutna bioraspoloživost indakaterola procijenjena je na raspon od 61 do 85% isporučene doze, i za glikopironij oko 47% isporučene doze.
English: Administration of Xoterna Breezhaler may result in paradoxical bronchospasm which can be life-threatening.
Croatian: Primjena Xoterna Breezhaler može dovesti do paradoksalnog bronhospazma koji može biti opasan po život.
English: 3H]-labelled glycopyrronium bromide, the mean urinary excretion of radioactivity in 48 hours amounted to 85% of the dose.
Croatian: Nakon intravenske primjene glikopironijevog bromida označenog sa [3H], srednje urinarno izlučivanje radioaktivnosti u 48 sati iznosilo je 85% doze.
English: There were no relevant effects of Xoterna Breezhaler on mean heart rate over 24 h and heart rate assessed after 30 minutes, 4 h and 24 h.
Croatian: Nije bilo značajnih učinaka Xoterna Breezhalera na srednju srčanu frekvenciju tijekom 24 h te na srčanu frekvenciju određenu nakon 30 minuta, 4 h i 24 h.
English: What Xoterna Breezhaler is and what it is used for What you need to know before you use Xoterna Breezhaler How to use Xoterna Breezhaler Possible side effects
Croatian: Što je Xoterna Breezhaler i za što se koristi Što morate znati prije nego počnete primjenjivati Xoterna Breezhaler Kako primjenjivati Xoterna Breezhaler Moguće nuspojave
English: This will also help you to remember to use it. You can inhale Xoterna Breezhaler any time before or after food or drink.
Croatian: Možete inhalirati Xoterna Breezhaler u bilo kojem trenutku prije ili nakon uzimanja hrane ili pića.
English: The components of Xoterna Breezhaler are not known to have a QT-prolongation potential at clinical dose levels.
Croatian: Za komponente Xoterna Breezhalera nije poznato da imaju potencijal produljenja QT potencijala pri kliničkim razinama doze.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xoterna Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary disease (COPD) (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Xoterna Breezhalera u svim podskupinama pedijatrijske populacije s kroničnom opstruktivnom plućnom bolešću (KOPB) (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Please read the full Instructions for Use before using the Xoterna Breezhaler.
Croatian: Pročitajte u cijelosti Upute za primjenu prije korištenja Xoterna Breezhalera.
English: Xoterna Breezhaler should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension).
Croatian: Xoterna Breezhaler treba primjenjivati s oprezom u bolesnika s kardiovaskularnim poremećajima (bolest koronarnih arteria, akutni infarkt miokarda, srčane aritmije, hipertenzija).
English: If you use more Xoterna Breezhaler than you should If you have inhaled too much of this medicine or if someone else accidentally uses your capsules, you must immediately either tell your doctor or go to the nearest emergency unit.
Croatian: Ako ste inhalirali previše ovog lijeka ili ako netko zabunom uzme Vaše kapsule, morate odmah obavijestiti svog liječnika ili otići u najbližu hitnu pomoć.
English: Xoterna Breezhaler should not be administered concomitantly with medicinal products containing other long-acting beta-adrenergic agonists or long-acting muscarinic antagonists, the pharmacotherapeutic groups to which the components of Xoterna Breezhaler belong (see section 4.5).
Croatian: Xoterna Breezhaler ne smije se primjenjivati istodobno s lijekovima koji sadrže druge dugodjelujuće beta-adrenergičke agoniste ili dugodjelujuće muskarinske antagoniste, farmakoterapijske skupine kojima pripadaju komponente Xoterna Breezhalera (vidjeti dio 4.5).
English: The presentation of the safety profile is based on the experience with Xoterna Breezhaler and the individual active substances.
Croatian: Prikaz sigurnosnog profila temelji se na iskustvu s Xoterna Breezhalerom i pojedinačnim djelatnim tvarima.
English: Xoterna Breezhaler is used as an ongoing treatment for your COPD.
Croatian: Xoterna Breezhaler se koristi kao kontinuirana terapija za Vaš KOPB.
English: The safety experience with Xoterna Breezhaler was comprised of exposure of up to 15 months at the recommended therapeutic dose.
Croatian: Iskustvo sa sigurnošću Xoterna Breezhalera obuhvaća izloženost u trajanju do 15 mjeseci pri preporučenoj terapijskoj dozi.
English: The combination of indacaterol and glycopyrronium in Xoterna Breezhaler showed a rapid onset of action within 5 minutes after dosing.
Croatian: Kombinacija indakaterola i glikopironija u Xoterna Breezhaleru pokazala je brzi nastup djelovanja u roku od 5 minuta od uzimanja doze.
English: No effects on the embryo or foetus were seen at any dose level of Xoterna Breezhaler during an embryo-foetal development study in rats.
Croatian: Nisu uočeni nikakvi učinci na embrio i fetus pri bilo kojoj razini Xoterna Breezhalera tijekom ispitivanja embrio-fetalnog razvoja u štakora.
English: A population pharmacokinetic analysis of data in COPD patients after inhalation of Xoterna Breezhaler indicated no significant effect of age, gender and (lean body) weight on the systemic exposure to indacaterol and glycopyrronium.
Croatian: Analiza podataka o farmakokinetici u populaciji bolesnika s KOPB-om nakon inhalacije Xoterna Breezhalera uputila je na nepostojanje značajnog učinka dobi, spola i (čiste tjelesne) težine na sistemsku izloženost indakaterolu i glikopironiju.
English: What Xoterna Breezhaler contains - The active substances are indacaterol (as maleate) and glycopyrronium bromide.
Croatian: Što Xoterna Breezhaler sadrži - Djelatne tvari su indakaterol (u obliku indakaterolmaleata) i glikopironijev bromid.
English: The co-administration of Xoterna Breezhaler with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Croatian: Istodobna primjena Xoterna Breezhalera s drugim lijekovima koji sadrže antikolinergike nije bila ispitivana pa se stoga ne preporučuje (vidjeti dio 4.4).
English: Not for acute use Xoterna Breezhaler is not indicated for the treatment of acute episodes of bronchospasm.
Croatian: Nije za akutnu primjenu Xoterna Breezhaler nije indiciran za liječenje akutnih epizoda bronhospazma.
English: There are no data available for the use of Xoterna Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2).
Croatian: Nema dostupnih podataka o primjeni Xoterna Breezhalera u bolesnika s teškim oštećenjem jetre, stoga je potreban oprez u tih bolesnika (vidjeti dio 5.2).
English: Increased heart rates were apparent in dogs at all doses of Xoterna Breezhaler and each monotherapy component.
Croatian: Povišene srčane frekvencije bile su uočljive u pasa pri svim dozama Xoterna Breezhalera i uz monoterapiju svakom od komponenti.
English: Xoterna Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Croatian: Xoterna Breezhaler je indiciran kao bronhodilatacijska terapija održavanja za ublažavanje simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB).
English: Only use the capsules with the inhaler provided in this pack (Xoterna
Croatian: Koristite kapsule samo uz inhalator priložen u ovom pakiranju (Xoterna Breezhaler inhalator).