FrancophonIA/ELRC3.0 huggingface dataset:
English: Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Croatian: Dodati pod nepoznata učestalost (učestalost se ne može procijeniti na temelju dostupnih podataka) Plućna arterijska hipertenzija - bolest jakog suženja krvnih žila u plućima što rezultira visokim krvnim tlakom u krvnim žilama koje prenose krv iz srca u pluća.
English: Cases of severe bradycardia and heart block have been observed when <brand name> is used in combination with <adapt according to the product> and concomitant amiodarone with or without other drugs that lower heart rate.
Croatian: Slučajevi teške bradikardije i srčanog bloka uočeni su kada se <trgovački naziv> koristi u kombinaciji s <prilagoditi ovisno o lijeku> i istovremeno s amiodaronom s ili bez drugih lijekova koji snižavaju srčanu frekvenciju.
English: Therefore, the MAH for trabectedin should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Croatian: Stoga, nositelj odobrenja za trabektedin treba podnijeti izmjenu u roku 2 mjeseca sa ciljem izmjene informacija o lijeku kako je niže opisano (novi tekst je podcrtan).
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with {X}.
Croatian: Nuspojave se mogu razviti u različitim vremenskim točkama tijekom liječnja, najčešće nekoliko mjeseci nakon početka liječenja s {X}.
English: The long half-life of amiodarone should be considered when deciding on cases for reviews
Croatian: Prilikom odlučivanja o slučajevima za preglede treba u obzir uzeti dugi poluvijek amiodarona.
English: “*Class label for interferon products, see below Pulmonary arterial hypertension.” Section 4.8c
Croatian: “*Značajka skupine lijekova koji sadrže interfereon, vidjeti niže Plućna arterijska hipertenzija.”
English: • Light-headedness
Croatian: • ošamućenost
English: [Interferon alfa-containing products]
Croatian: [Lijekovi koji sadrže interferon beta]
English: Section 4 - Possible side effects
Croatian: Dio 4 - Moguće nuspojave [Lijekovi koji sadrže interferon alfa]
English: Statistical superiority was also analysed.
Croatian: Statistička superiornost također je analizirana.
English: When to seek medical advice
Croatian: Kada potražiti liječnički savjet
English: The overall occurence was low.
Croatian: Ukupna pojavnost bila je niska.
English: if you weigh 50 kg or less.
Croatian: ako imate 50 kg ili manje.
English: Patients were followed-up for 2 years.
Croatian: Bolesnici su bili praćeni tijekom 2 godine.
English: The potential risk for humans is unknown.
Croatian: Potencijalni rizik u ljudi nije poznat.
English: 28-35 days
Croatian: 28-35 dana
English: if you are older than 75 years.
Croatian: ako ste stariji od 75 godina.
English: Blister and bottle 3 years
Croatian: Blister i boca 3 godine
English: Please complete this section or ask your doctor to do it.
Croatian: Molimo, ispunite ovaj dio ili zamolite liječnika da to učini.
English: ® safely, please consider the important information inside.
Croatian: ®, molimo uzmite u obzir važne informacije koje se u njoj nalaze.
English: This should be considered in advance of any procedures.
Croatian: To je važno uzeti u obzir prije svakog postupka.
English: Specific treatment options are available.
Croatian: Dostupne su mogućnosti posebnog liječenja.
English: • Inform your doctor about all medicines you are currently taking.
Croatian: • Obavijestite liječnika o svim lijekovima koje trenutno primjenjujete.
English: Standard risk
Croatian: Standardni rizik
English: 2-3 days before (> 48 hours)
Croatian: 2-3 dana prije (> 48 sati)
English: Pradaxa is not recommended in children and adolescents below 18 years old.
Croatian: Pradaxa se ne preporučuje u djece i adolescenata ispod 18 godina starosti.
English: Traces of other metabolites were only detectable with highly sensitive analytical methods.
Croatian: Tragovi drugih metabolita mogli su se naći samo uz visoko osjetljive analitičke metode.
English: In addition, in a non-interventional study [Graham DJ et al., Circulation.
Croatian: Povrh toga, u neintervencijskom ispitivanju [Graham DJ et al., Circulation.
English: No human data available.
Croatian: Nisu dostupni podaci za ljude.
English: Date of birth
Croatian: Datum rođenja
English: Therapy should be continued long term.
Croatian: Terapija treba biti dugotrajna.
English: Not calculable*
Croatian: Ne može se izračunati*
English: Pradaxa is used in adults to:
Croatian: Pradaxa se primjenjuje u odraslih za:
English: No rebound effect was observed.
Croatian: Nije bio primijećen povratni učinak.
English: • SSRIs or SNRIs
Croatian: • SSRI ili SNRI
English: If you take more Pradaxa than you should
Croatian: Ako uzmete više Pradaxe nego što ste trebali
English: Glecaprevir / pibrentasvir
Croatian: Glekaprevir/pibrentasvir
English: • Recommendations for dose reduction in at risk populations
Croatian: • Preporuke za sniženje doze u rizičnim populacijama
English: Similar values for CrCL were found in RE-COVER II.
Croatian: Slične vrijednosti za CrCL pronađene su i u ispitivanju RE-COVER II.
English: These affect P-gp (either as inhibitor or as inducer).
Croatian: Oni utječu na P-gp (ili kao inhibitor ili kao induktor).
English: • The use of coagulation tests and their interpretation
Croatian: • Primjena koagulacijskih testova i njihova interpretacija
English: The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational pack.
Croatian: Nositelj odobrenja mora dogovoriti sadržaj i format edukativnih materijala, zajedno s komunikacijskim planom, s nadležnim nacionalnim tijelom prije distribucije edukativnog paketa.
English: Take Pradaxa exactly as prescribed.
Croatian: Uzimajte Pradaxu točno kako je propisano.
English: All-cause deaths
Croatian: Smrti svih uzroka
English: Data from non-interventional studies
Croatian: Podaci iz neintervencijskih ispitivanja
English: Without specific guidance from your doctor do not change your anticoagulant treatment.
Croatian: Ako niste dobili posebne upute od svog liječnika, ne mijenjajte svoje antikoagulacijsko liječenje.
English: No further increase in bioavailability was observed after another 7 days.
Croatian: Nije primijećeno dodatno povećanje bioraspoloživosti nakon sljedećih 7 dana.
English: Cmax and AUC were dose proportional.
Croatian: Cmax i AUC bili su proporcionalni dozi.
English: Component of a multipack, can´t be sold separately.
Croatian: Dio višestrukog pakiranja, ne može se prodavati pojedinačno.
English: What Pradaxa looks like and contents of the pack
Croatian: Kako Pradaxa izgleda i sadržaj pakiranja
English: Currently available data are described in section 4.8 and 5.1, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8 i 5.1, ali ne može se dati preporuka za doziranje.
English: Pradaxa can be given as soon as the INR is < 2.0.
Croatian: Pradaxa se može davati čim je INR < 2,0.
English: - if you have an increased bleeding risk, such as: if you have been recently bleeding.
Croatian: ako ste pod povećanim rizikom od krvarenja, primjerice: ako ste nedavno krvarili.
English: Postoperative phase
Croatian: Postoperativna faza
English: The starting time of the VKA should be adjusted based on CrCL as follows:
Croatian: Početno vrijeme doziranja VKA treba prilagoditi na osnovi CrCL-a kako slijedi:
English: Symptomatic PE
Croatian: Simptomatski PE
English: Coagulation factor concentrates (activated or non-activated) or recombinant Factor VIIa may be taken into account.
Croatian: U obzir se mogu uzeti koncentrati koagulacijskih faktora (aktivirani ili neaktivirani) ili rekombinantni faktor VIIa.
English: Therefore treatment is not recommended.
Croatian: Stoga se liječenje ne preporučuje.
English: Concomitant use should be avoided.
Croatian: Istodobnu primjenu je potrebno izbjegavati.
English: No other effects on female fertility were observed.
Croatian: Nisu primijećeni drugi učinci na žensku plodnost.
English: Protease inhibitors such as ritonavir
Croatian: Inhibitori proteaze kao što je ritonavir
English: You should not take Pradaxa if you are pregnant unless your doctor advises you that it is safe to do so.
Croatian: Ne biste smjeli uzimati Pradaxu ako ste trudni, osim ako Vam liječnik ne savjetuje da je njena primjena sigurna.
English: [xxxx 201x] [Boehringer Ingelheim logo]
Croatian: [xxxxx201x] [logo Boehringer Ingelheim]
English: What Pradaxa contains
Croatian: Što Pradaxa sadrži
English: • The cap opens by pushing and turning.
Croatian: • Zatvarač se otvara pritiskanjem i okretanjem.
English: For the indication DVT/PE, the safety and efficacy of Pradaxa in children from birth to less than 18 years of age have not yet been established.
Croatian: Za indikaciju DVT/PE, sigurnost i učinkovitost Pradaxe kod djece, od njihova rođenja do manje od 18 godina starosti, još uvijek nisu utvrđene.
English: What Pradaxa is and what it is used for
Croatian: Što je Pradaxa i za što se koristi
English: It was demonstrated in a further study that slow and delayed absorption is usually only present on the day of surgery.
Croatian: Pokazalo se, u daljnjem ispitivanju, da je usporena i odgođena apsorpcija obično prisutna samo na dan zahvata.
English: Caution should be exercised when interpreting these tests.
Croatian: Potreban je oprez u interpretaciji spomenutih testova.
English: • Bacterial endocarditis
Croatian: • bakterijski endokarditis
English: Pradaxa treatment should not be discontinued without medical advice.
Croatian: Liječenje Pradaxom ne smije se prekinuti bez liječničkog savjeta.
English: In some cases these bleedings may not be obvious.
Croatian: U nekim slučajevima, ova krvarenja ne moraju biti primijećena.
English: This risk of bleeding should be weighed against the urgency of intervention.
Croatian: Potrebno je odvagnuti rizik od krvarenja u odnosu na hitnost intervencije.
English: % refers to yearly event rate
Croatian: % se odnosi na godišnju stopu događaja
English: Your doctor may decide to keep you under closer observation or change your medicine.
Croatian: Liječnik će odlučiti hoće li Vas držati pod pažljivijim nadzorom ili promijeniti lijek.
English: There was no influence on male fertility.
Croatian: Nije bilo utjecaja na mušku plodnost.
English: After an intravenous dose, the dabigatran-derived radioactivity was eliminated primarily in the urine (85 %).
Croatian: Nakon intravenske doze, radioaktivnost vezana za dabigatran eliminirana je primarno urinom (85 %).
English: • That all patients should be provided with a Patient alert card and be counselled about: Signs or symptoms of bleeding and when to seek attention from a health care provider.
Croatian: • Da svi bolesnici moraju imati Kartice s upozorenjima za bolesnike te ih se mora savjetovati o: Znakovima i simptomima krvarenja i kada potražiti pomoć medicinskog djelatnika.
English: Patients should be instructed not to open the capsule as this may increase the risk of bleeding (see sections 5.2 and 6.6).
Croatian: Bolesnike je potrebno uputiti da ne otvaraju kapsulu s obzirom da to može povećati rizik od krvarenja (vidjeti dijelove 5.2 i 6.6).
English: [Pradaxa logo]
Croatian: [logo Pradaxe]
English: ® without talking to your doctor.
Croatian: ® bez savjetovanja s liječnikom.
English: See 'Other medicines and Pradaxa' below.
Croatian: Pogledajte „Drugi lijekovi i Pradaxa“ niže.
English: Estimated half-life (hours)
Croatian: Procijenjeni poluvijek (sati)
English: The effects of Pradaxa on pregnancy and the unborn child are not known.
Croatian: Učinci Pradaxe na trudnoću i nerođeno dijete nisu poznati.
English: Swallow the capsule whole with a glass of water.
Croatian: Kapsulu progutajte cijelu s čašom vode.
English: Pradaxa should not be used during pregnancy unless clearly necessary.
Croatian: Pradaxa se ne smije primjenjivati tijekom trudnoće, osim ako to nije izrazito neophodno.
English: Age (years) 65 ≤ and < 75
Croatian: Dob (godine) 65 ≤ i < 75
English: The Prescriber Guide should contain the following key safety messages:
Croatian: Uputa za propisivača lijeka mora sadržavati sljedeće ključne poruke o sigurnosti:
English: See further down and sections 4.4, 4.5, 5.1 and 5.2.
Croatian: Vidjeti nastavak teksta i dijelove 4.4, 4.5, 5.1 i 5.2.
English: Based on in vitro results a similar effect as with ketoconazole may be expected.
Croatian: Na temelju in vitro rezultata može se očekivati sličan učinak kao i s ketokonazolom.
English: The signs, symptoms, and severity (including fatal outcome) will vary according to the location and degree or extent of the bleeding and/or anaemia.
Croatian: Znakovi, simptomi i težina (uključujući smrtni ishod) razlikovat će se ovisno o mjestu i stupnju ili opsežnosti krvarenja i/ili anemije.
English: Instructions for opening the blisters
Croatian: Upute za otvaranje blistera
English: Since thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of thrombus.
Croatian: S obzirom da trombin (serin proteaza) omogućava konverziju fibrinogena u fibrin tijekom koagulacijske kaskade, njegova inhibicija sprječava razvoj tromba.
English: CrCL(mL/min) 30 ≤ and < 50 50 ≤ and < 80
Croatian: CrCL(mL/min) 30 ≤ i < 50 50 ≤ i < 80
English: • If you fall or injure yourself, especially if you hit your head, urgently seek medical advice.
Croatian: • Ako padnete ili se ozlijedite, osobito ako udarite glavom, hitno potražite liječnički savjet.
English: ® TT (Anti-FIIa) 1.36 fold, respectively.
Croatian: ® TT (Anti-FIIa) 1,36 puta.
English: The educational pack must be available for distribution for all therapeutic indications prior to launch ) in the Member State.
Croatian: Edukativni paket mora biti raspoloživ za distribuciju za sve terapijske indikacije prije stavljanja na tržište u zemlji članici.
English: • Information on medicinal products that are contraindicated or which should be used with caution due to an increased risk of bleeding and/or increased dabigatran exposure
Croatian: • Informacije o lijekovima koji su kontraindicirani ili koji se primjenjuju s oprezom zbog povećanog rizika od krvarenja i/ili povećane izloženosti dabigatranu
English: Thereafter two capsules once a day should be taken for a total of 28-35 days.
Croatian: Nakon toga se uzimaju dvije kapsule jedanput dnevno u ukupnom trajanju od 28 - 35 dana.
English: In particular you should tell your doctor before taking Pradaxa, if you are taking one of the medicines listed below:
Croatian: Osobito morate obavijestiti svog liječnika prije uzimanja Pradaxe ako uzimate jedan od lijekova sa sljedećeg popisa:
English: The following pictogram illustrates how to take Pradaxa capsules out of the blister
Croatian: Sljedeći piktogram pokazuje kako izvaditi Pradaxa kapsule iz blistera
English: All symptomatic treatment should be given according to the physician's judgement.
Croatian: Svako simptomatsko liječenje se pruža u skladu s liječničkom procjenom.
English: Should not be performed
Croatian: Ne treba se provoditi
English: Date of the latest renewal: 08 January 2018
Croatian: Datum posljednje obnove odobrenja: 08. siječnja 2018.
English: Maintenance dose starting on the first day after surgery
Croatian: Doza održavanja počevši od prvog dana nakon kirurškog zahvata
English: • Lesion or condition, if considered a significant risk factor for major bleeding.
Croatian: • Lezija ili stanje, ako se smatra značajnim faktorom rizika za veliko krvarenje.
English: In these four phase III trials, 16,709 patients were exposed to Pradaxa (see Table 9).
Croatian: U ta četiri ispitivanja faze III, 16 709 bolesnika bilo je izloženo Pradaxi (vidjeti tablicu 9).
English: Take Pradaxa as recommended for the following conditions:
Croatian: Primjenjujte Pradaxu kako je preporučeno za sljedeća stanja:
English: Duration of maintenance dose
Croatian: Trajanje primjene doze održavanja
English: The half-life was independent of dose.
Croatian: Poluvijek nije ovisio o dozi.
English: In the pooled RE-COVER and RE-COVER II studies, a total of 5,153 patients were randomised and 5,107 were treated.
Croatian: U združenim ispitivanjima RE-COVER i RE-COVER II, ukupno je randomizirano 5 153 bolesnika, a 5 107 ih je liječeno.
English: The MAH shall provide an educational pack for each therapeutic indication, targeting all physicians who are expected to prescribe/use Pradaxa.
Croatian: Nositelj odobrenja osigurat će edukativni paket za svaku terapijsku indikaciju, ciljajući na sve liječnike za koje se očekuje da će propisivati/primjenjivati Pradaxu.
English: Other medicines and Pradaxa
Croatian: Drugi lijekovi i Pradaxa
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Artical 107c(7) of Directive 1002/83/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: The physician educational pack should contain:
Croatian: Edukativni paket za liječnike mora sadržavati sljedeće:
English: Coagulation tests may become unreliable following administration of suggested coagulation factor concentrates.
Croatian: Testovi koagulacije mogu biti nepouzdani nakon primjene predloženih koncentrata koagulacijskih faktora.
English: ® is mainly eliminated by the kidneys; adequate diuresis must be maintained.
Croatian: ® se uglavnom eliminira putem bubrega; odgovarajuća diureza se mora održavati.
English: Depending on local availability, a consultation of a coagulation expert should be considered in case of major bleedings.
Croatian: Zavisno od lokalne dostupnosti, potrebno je posavjetovati se sa specijalistom za koagulaciju u slučaju velikih krvarenja.
English: Mean on-therapy follow-up time was 18.3 months.
Croatian: Srednja vrijednost vremena praćenja tijekom terapije bila je 18,3 mjeseci.
English: Dabigatran is eliminated primarily in the unchanged form in the urine, at a rate of approximately 100 mL/min corresponding to the glomerular filtration rate.
Croatian: Dabigatran se eliminira primarno u nepromijenjenom obliku u urinu, brzinom od oko 100 mL/min, što odgovara brzini glomerularne filtracije.
English: This effect was seen primarily in patients ≥ 75 years.
Croatian: Ovaj učinak primijećen je prvenstveno u bolesnika ≥ 75 godina.
English: You may also need to talk to your doctor during treatment with Pradaxa if you experience symptoms or if you have to undergo surgery.
Croatian: Također se savjetujte s liječnikom tijekom liječenja Pradaxom ako primijetite simptome ili se morate podvrgnuti kirurškom zahvatu.
English: Name of the patient
Croatian: Ime bolesnika
English: The study included observational follow-up for 12 months after the conclusion of treatment.
Croatian: Ispitivanje je uključivalo opservacijsko razdoblje praćenja u trajanju 12 mjeseci nakon prekida liječenja.
English: For the primary safety endpoint of major bleeding there was an interaction of treatment effect and age.
Croatian: Za primarni ishod sigurnosti - veliko krvarenje - postojala je interakcija učinka liječenja i dobi.
English: As this patient alert card contains important information about your treatment, please carry this card with you at all times to inform healthcare professionals about your intake of Pradaxa
Croatian: S obzirom da ova Kartica s upozorenjima za bolesnika sadrži važne informacije o vašem liječenju, molimo da uvijek nosite ovu karticu sa sobom kako biste mogli informirati zdravstvene djelatnike da primjenjujete Pradaxu
English: In view of the long half-life of amiodarone the potential for an interaction may exist for weeks after discontinuation of amiodarone (see sections 4.2 and 4.4).
Croatian: S obzirom na dugačak poluvijek amiodarona, potencijal za interakciju može postojati tjednima nakon prekida primjene amiodarona (vidjeti dijelove 4.2 i 4.4).
English: Stroke and/or systemic embolism
Croatian: Moždani udar i/ili sistemska embolija
English: • Low body weight (< 50 kg)
Croatian: • niska tjelesna težina (< 50 kg)
English: Relative risk was highest in patients ≥ 75 years.
Croatian: Relativni rizik bio je najviši u bolesnika ≥ 75 godina starosti.
English: The duration of treatment with fixed dose of dabigatran was 174.0 days without coagulation monitoring.
Croatian: Trajanje liječenja fiksnom dozom dabigatrana bilo je 174,0 dana bez praćenja koagulacije.
English: Totals of 2,076 patients (knee) and 3,494 (hip) were treated respectively.
Croatian: Ukupno je bilo liječeno 2 076 bolesnika (koljeno) i 3 494 (kuk).
English: After multiple doses a terminal half-life of about 12-14 hours was observed.
Croatian: Nakon višestrukih doza opažen je terminalni poluvijek od oko 12-14 sati.
English: Contact your doctor immediately if you have taken too many Pradaxa capsules.
Croatian: Odmah se obratite liječniku ako ste uzeli previše kapsula Pradaxe.
English: There was no significant interaction of treatment effects with the subgroups of renal function and CHADS2 score.
Croatian: Nije bilo značajnih interakcija učinka liječenja s podskupinama bubrežne funkcije i CHADS2 skora.
English: In lifetime toxicology studies in rats and mice, there was no evidence for a tumorigenic potential of dabigatran up to maximum doses of 200 mg/kg.
Croatian: U ispitivanjima doživotne toksičnosti na štakorima i miševima nije bilo dokaza tumorogenog potencijala dabigatrana pri maksimalnim dozama do 200 mg/kg.
English: They have not been studied and are therefore not recommended for concomitant treatment with Pradaxa.
Croatian: Oni nisu ispitivani te se stoga ne preporučuju u istodobnom liječenju s Pradaxom.
English: Enoxaparin N (%)
Croatian: Enoksaparin N (%)
English: If surgery cannot be delayed the risk of bleeding may be increased.
Croatian: Ako se kirurški zahvat ne može odgoditi, rizik od krvarenja se može povećati.
English: Driving and using machines
Croatian: Upravljanjevozilima i strojevima
English: Pradaxa ® Information for Healthcare Professionals
Croatian: Pradaxa® Informacije za zdravstvene radnike
English: These patients require frequent observation for neurological signs and symptoms of spinal or epidural haematoma.
Croatian: Ovi bolesnici zahtijevaju promatranje neuroloških znakova i simptoma spinalnog ili epiduralnog hematoma.
English: Thereafter two capsules once a day should be taken for a total of 10 days.
Croatian: Nakon toga se uzimaju dvije kapsule jedanput dnevno u ukupnom trajanju od 10 dana.
English: Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.
Croatian: Kratko trajanje terapije (najmanje 3 mjeseca) mora se odrediti prema prolaznim faktorima rizika (npr. nedavni kirurški zahvat, trauma, imobilizacija), a dulje trajanje se mora odrediti prema trajnim faktorima rizika ili da li se radi o idiopatskom DVT-u ili PE-u.
English: • Contraindication for patients with prosthetic heart valves requiring anticoagulant treatment
Croatian: • Kontraindikacija za bolesnike s umjetnim srčanim zaliscima kojima je potrebno antikoagulantno liječenje
English: Effects observed in the repeated dose toxicity studies were due to the exaggerated pharmacodynamic effect of dabigatran.
Croatian: Učinci primjećeni u ispitivanjima toksičnosti ponovljenih doza bili su uzrokovani pretjeranim farmakodinamičkim učinkom dabigatrana.
English: • After removing the capsule, place the cap back on the bottle and tightly close the bottle right away after you take your dose.
Croatian: • Nakon vađenja kapsule, vratite zatvarač na bocu, a bocu čvrsto zatvorite odmah nakon primjene doze.