FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with Ondexxya, especially those aged over 75 years, may be at a higher risk of thromboembolism.
Croatian: Bolesnici liječeni lijekom Ondexxya, posebno bolesnici stariji od 75 godina, mogli bi biti izloženi povećanom riziku od tromboembolije.
English: These anticoagulants work by blocking factor Xa, a natural protein that helps the blood to clot.
Croatian: Ti antikoagulansi djeluju tako da blokiraju učinak faktora Xa, prirodnog proteina koji pomaže u zgrušavanju krvi.
English: The main measure of effectiveness was the reduction in 'antifactor Xa activity' (a measure of how well natural factor Xa is blocked by an anticoagulant).
Croatian: Glavno mjerilo djelotvornosti bilo je smanjenje „anti-faktor Xa aktivnosti” (mjera uspješnosti antikoagulansa u blokiranju prirodnog faktora Xa).
English: However, the Agency also noted the unmet medical need to stop life-threatening or uncontrolled bleeding caused by factor Xa inhibitors.
Croatian: Međutim, Agencija je također zaključila da postoji nezadovoljena medicinska potreba da se zaustavi po život opasno ili nekontrolirano krvarenje koje uzrokuju inhibitori faktora Xa.
English: Ondexxya has been given ‘conditional authorisation'.
Croatian: Za lijek Ondexxya izdano je „uvjetno odobrenje”.
English: For more information about using Ondexxya, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Ondexxya pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Ondexxya is given by infusion (drip) into a vein over about 2.5 hours.
Croatian: Ondexxya se primjenjuje intravenskom infuzijom (ukapavanje) u trajanju od otprilike dva i pol sata.
English: What measures are being taken to ensure the safe and effective use of Ondexxya?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ondexxya?
English: The dose depends on what the last dose of the anticoagulant was and when the patient took it.
Croatian: Doza ovisi o posljednjoj primljenoj dozi antikoagulansa i vremenu njezine primjene.
English: The company will also carry out studies to gain more information on the effects and blood levels of Ondexxya and to confirm the dosage recommendations.
Croatian: Tvrtka će također provesti ispitivanja kako bi se prikupilo više informacija o učincima i razinama lijeka Ondexxya u krvi te kako bi se potvrdile preporuke u vezi s doziranjem.
English: Ondexxya can only be obtained with a prescription and it must be used in hospital only.
Croatian: Lijek Ondexxya izdaje se samo na recept, a može se primjenjivati samo u bolnici.
English: The European Medicines Agency noted that it has not been established that antifactor Xa activity can be used as a reliable measure for reduced bleeding and that there was not enough evidence on the use of Ondexxya to reverse the effects of edoxaban, another factor Xa inhibitor.
Croatian: Europska agencija za lijekove zaključila je da nije ustanovljeno da se anti-faktor Xa aktivnosti može upotrebljavati kao pouzdano mjerilo za smanjeno krvarenje te da nema dovoljno dokaza u vezi s primjenom lijeka Ondexxya za reverziju učinka edoksabana, drugog inhibitora faktora Xa.
English: Side effects reported with Ondexxya are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ondexxya pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Ondexxya is a medicine used for stopping life-threatening or uncontrolled bleeding in adults taking the anticoagulant medicines apixaban or rivaroxaban.
Croatian: Ondexxya je lijek koji se primjenjuje za zaustavljanje po život opasnog ili nekontroliranog krvarenja u odraslih osoba koje uzimaju antikoagulanse apiksaban ili rivaroksaban.
English: Based on studies in healthy volunteers, the most common side effects with Ondexxya (which may affect more than 1 in 10 people) are flushing, feeling hot, both of which are related to infusing the medicine, and a short-lived increase in levels of certain proteins indicating blood clotting.
Croatian: Na temelju ispitivanja na zdravim dobrovoljcima, najčešće nuspojave lijeka Ondexxya (koje se mogu javiti u više od 1 na 10 osoba) jesu navale crvenila i osjećaj vrućine, povezani s davanjem infuzije lijeka, te kratkotrajan porast razine određenih proteina koji ukazuju na zgrušavanje krvi.
English: What is Ondexxya and what is it used for?
Croatian: Što je Ondexxya i za što se primjenjuje?
English: As for all medicines, data on the use of Ondexxya are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Ondexxya kontinuirano se prate.
English: Since Ondexxya has been given conditional authorisation, the company that markets Ondexxya will provide evidence from studies in patients with major bleeding to reliably link antifactor X activity with the ability to stop bleeding and to clarify the risk of thromboembolism.
Croatian: Budući da je lijek Ondexxya dobio uvjetno odobrenje, tvrtka koja stavlja lijek Ondexxya u promet dostavit će dokaze iz ispitivanja na bolesnicima s velikim krvarenjem kako bi se pouzdano povezala anti-faktor Xa aktivnosti sa sposobnošću zaustavljanja krvarenja te kako bi se razjasnio rizik od tromboembolije.
English: After treatment with Ondexxya, antifactor Xa activity was reduced on average by 90% in 83 patients taking apixaban and by 78% in 70 patients taking rivaroxaban.
Croatian: Nakon liječenja lijekom Ondexxya anti-faktor Xa aktivnosti u prosjeku je smanjena za 90 % u 83 bolesnika koji su primali apiksaban i za 78 % u 70 bolesnika koji su primali rivaroksaban.
English: The Agency therefore decided that Ondexxya's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Stoga je Agencija zaključila da koristi od lijeka Ondexxya nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Ondexxya must not be used in patients who are allergic to hamster proteins.
Croatian: Lijek Ondexxya ne smije se primjenjivati u bolesnika koji su alergični na proteine hrčka.
English: Recommendations and precautions to be followed by healthcare professionals for the safe and effective use of Ondexxya have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ondexxya nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: An overview of Ondexxya and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ondexxya i zašto je odobren u EU-u
English: Other information about Ondexxya
Croatian: Ostale informacije o lijeku Ondexxya
English: Why is Ondexxya authorised in the EU?
Croatian: Zašto je lijek Ondexxya odobren u EU-u?
English: On the basis of studies in healthy volunteers and preliminary data from studies in patients, Ondexxya was found effective for reducing antifactor Xa activity in those taking anticoagulants that block factor Xa (factor Xa inhibitors).
Croatian: Na temelju ispitivanja na zdravim dobrovoljcima i preliminarnih podataka iz ispitivanja na bolesnicima utvrđeno je da je lijek Ondexxya učinkovit u smanjenju anti-faktor Xa aktivnosti u osoba koje uzimaju antikoagulanse koji blokiraju djelovanje faktora Xa (inhibitori faktora Xa).
English: Two main studies have found Ondexxya effective in healthy volunteers who took either apixaban or rivaroxaban, two anticoagulants that block the effect of factor Xa.
Croatian: Djelotvornost lijeka Ondexxya utvrđena je u dvama glavnim ispitivanjima na zdravim dobrovoljcima koji su primili apiksaban ili rivaroksaban, dva antikoagulansa koji blokiraju učinak faktora Xa.
English: A further ongoing study involved patients taking a factor Xa inhibitor anticoagulant who had major bleeding.
Croatian: Dodatno ispitivanje koje je u tijeku obuhvatilo je bolesnike koji primaju antikoagulans koji je inhibitor faktora Xa te su imali veliko krvarenje.
English: What are the risks associated with Ondexxya?
Croatian: Koji su rizici povezani s lijekom Ondexxya?
English: In the first study, involving people who had taken apixaban, the full dose of Ondexxya reduced antifactor Xa activity by 92% on average in 23 people compared with 33% in 8 people receiving placebo (a dummy treatment).
Croatian: U prvom ispitivanju, koje je obuhvatilo osobe koje su primile apiksaban, primjena pune doze lijeka Ondexxya u prosjeku je smanjila anti-faktor Xa aktivnosti za 92 % u 23 osobe, u usporedbi s 33 % u osam osoba koje su primile placebo (prividno liječenje).
English: involving people who had taken rivaroxaban, the full dose of Ondexxya reduced antifactor Xa activity by 97% on average in 26 people, compared with 45% in 13 people receiving placebo.
Croatian: U drugom ispitivanju, koje je obuhvatilo osobe koje su primile rivaroksaban, primjena pune doze lijeka Ondexxya u prosjeku je smanjila anti-faktor Xa aktivnosti za 97 % u 26 osoba, u usporedbi s 45 % u 13 osoba koje su primile placebo.
English: When Ondexxya is given, the anticoagulants attach to andexanet alfa instead, and they are no longer available to block factor Xa.
Croatian: Nakon primjene lijeka Ondexxya antikoagulansi se vezuju za andeksanet alfa te više nisu raspoloživi za blokiranje učinka faktora Xa.
English: Andexanet alfa, the active substance in Ondexxya, acts as a decoy target for anticoagulants called factor Xa inhibitors such as apixaban and rivaroxaban.
Croatian: Djelatna tvar u lijeku Ondexxya, andeksanet alfa, djeluje kao lažni receptor za antikoagulanse koji se nazivaju inhibitori faktora Xa, kao što su apiksaban i rivaroksaban.
English: What information is still awaited for Ondexxya?
Croatian: Koje se još informacije očekuju o lijeku Ondexxya?
English: How does Ondexxya work?
Croatian: Kako djeluje Ondexxya?
English: Ondexxya contains the active substance andexanet alfa.
Croatian: Lijek Ondexxya sadrži djelatnu tvar andeksanet alfa.
English: What benefits of Ondexxya have been shown in studies?
Croatian: Koje su koristi od lijeka Ondexxya utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions of Ondexxya, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Ondexxya potražite u uputi o lijeku.
English: In other cases, seek help as soon as possible
Croatian: U svim drugim slučajevima, potražite pomoć što je prije moguće.
English: The majority of these reactions were mild or moderate.
Croatian: Većina tih reakcija bile su blage ili umjerene.
English: The following procedure shows how you do this.
Croatian: Sljedeći opis prikazuje kako to učiniti.
English: Paediatric population (≥1 year)
Croatian: Pedijatrijska populacija (≥1 godine)
English: The clinical studies conducted could neither exclude nor confirm such an increased risk.
Croatian: Provedena klinička ispitivanja nisu mogla isključiti niti potvrditi takav povećani rizik.
English: Long-term safety data are not yet available for this paediatric population.
Croatian: Podaci o dugoročnoj sigurnosti primjene još nisu dostupni za ovu pedijatrijsku populaciju.
English: See Table 1 under “Adults” section.
Croatian: Vidjeti tablicu 1 u dijelu “Odrasli”.
English: These changes were neither associated with any changes in other laboratory parameters nor with any reported clinical symptoms.
Croatian: Te promjene nisu bile povezane s bilo kakvim promjenama ostalih laboratorijskih parametara ili bilo kakvim prijavljenim kliničkim simptomima.
English: Do not touch the top of the vial.
Croatian: Ne dodirujte vrh bočice.
English: With the other hand, hold the syringe as you would with a pencil.
Croatian: Drugom rukom držite štrcaljku kao što biste držali olovku.
English: Treatment should be stopped if no overall improvement of the patient condition is achieved.
Croatian: Liječenje treba prekinuti ako se ne postigne nikakvo opće poboljšanje stanja bolesnika.
English: Subsequent colonoscopies are recommended at a minimum of five year intervals.
Croatian: Naknadne kolonoskopije preporučuju se u razmacima od najmanje pet godina.
English: - if you have other severe diseases that are not well controlled.
Croatian: - ako imate druge teške bolesti koje nisu dobro kontrolirane.
English: What Revestive is and what it is used for
Croatian: Što je Revestive i za što se koristi
English: No subject discontinued the studies due to an adverse event.
Croatian: Nijedan ispitanik nije prekinuo ispitivanje zbog štetnog događaja.
English: Active or suspected malignancy.
Croatian: Aktivna zloćudna bolest ili sumnja na nju.
English: This assessment should be conducted more frequently within the first months of treatment.
Croatian: Te procjene treba provoditi češće u prvim mjesecima liječenja.
English: Try to inject in another place in the cleaned skin area.
Croatian: Pokušajte dati injekciju na drugo mjesto na očišćenom području kože.
English: If this happens to you, do not drive or use machines until you feel better.
Croatian: Ako Vam se to dogodi, ne upravljajte vozilima i strojevima dok se ne budete osjećali bolje.
English: Date of first authorisation: 30 August 2012 Date of latest renewal: 23 June 2017
Croatian: Datum posljednje obnove odobrenja: 23. lipnja 2017.
English: These observations were not confirmed in clinical studies of more than one year duration.
Croatian: Ta opažanja nisu potvrđena u kliničkim ispitivanjima u trajanju duljem od godine dana.
English: You can still use the medicine that is already in the syringe.
Croatian: I dalje možete iskoristiti lijek koji je u štrcaljki.
English: Children below 1 year of age
Croatian: Djeca mlađa od 1 godine
English: Boehringer Ingelheim RCV GmbH & Co KG Dr. Boehringer-Gasse 5-11
Croatian: Boehringer Ingelheim RCV GmbH & Co KG Dr. Boerhringer-Gasse 5-11
English: Experience in subjects 75 years and above is limited.
Croatian: Iskustvo s osobama u dobi od 75 i više godina je ograničeno.
English: A risk to the breast-fed newborn/infant cannot be excluded.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče.
English: There are no data available in paediatric patients after 6 months (see section 5.1).
Croatian: Nema podataka za pedijatrijske bolesnike nakon 6 mjeseci (vidjeti dio 5.1).
English: - if your child has other severe diseases that are not well controlled.
Croatian: - ako Vaše dijete ima druge teške bolesti koje nisu dobro kontrolirane.
English: The absolute bioavailability of subcutaneous teduglutide is high (88%).
Croatian: Apsolutna bioraspoloživost supkutanog teduglutida je visoka (88%).
English: In general, the side effects in children and adolescents are similar to those seen in adults.
Croatian: Općenito gledano, nuspojave u djece i adolescenata slične su onima opaženima u odraslih.
English: Despite the limited sample size, which did not allow meaningful statistical comparisons, clinically meaningful, numerical reductions in the requirement for parenteral support were observed across all age groups.
Croatian: Unatoč ograničenoj veličini uzorka, koja nije omogućila značajne statističke usporedbe, klinički značajna, numerička smanjenja zahtjeva za parenteralnom potporom opažena su u svim dobnim skupinama.
English: Seek immediate medical attention if any of the following side effects occur:
Croatian: Odmah potražite liječničku pomoć ako se jave neke od sljedećih nuspojava:
English: Treatment effect should be evaluated after 6 months.
Croatian: Učinak liječenja treba procijeniti nakon 6 mjeseci.
English: Paediatric population See also general precautions for adults under this section.
Croatian: Pedijatrijska populacija Vidjeti također opće mjere opreza za odrasle navedene u ovom dijelu.
English: In general, fluid overload can be prevented by appropriate and timely assessment of parenteral nutrition needs.
Croatian: Preopterećenje tekućinom uglavnom se može spriječiti primjerenom i pravovremenom procjenom potreba za parenteralnom prehranom.
English: Other medicines and Revestive
Croatian: Drugi lijekovi i Revestive
English: It is often caused by surgical removal of all or part of the small intestine.
Croatian: Često je uzrokovan kirurškim odstranjenjem cijelog ili dijela tankog crijeva.
English: NOTE: Before you start, make sure you have a clean work surface and that you have washed your hands before proceeding.
Croatian: Prije početka osigurajte čistu radnu površinu i operite ruke prije postupka.
English: Never use more than one injection in the same day.
Croatian: U istom danu ne smijete primijeniti više od jedne injekcije.
English: This container must be puncture proof (top and sides).
Croatian: Taj spremnik mora biti neprobojan (odozgo i sa strane).
English: What Revestive contains
Croatian: Što Revestive sadrži
English: Let the vial rest for approximately 30 seconds.
Croatian: Ostavite bočicu da miruje približno 30 sekundi.
English: What Revestive looks like and contents of the pack
Croatian: Kako Revestive izgleda i sadržaj pakiranja
English: 2.6 Let the vial rest for about two minutes.
Croatian: 2.6 Ostavite bočicu da miruje oko dvije minute.
English: Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Croatian: Učestalost se definira kao vrlo često (1/10), često (1/100 i <1/10), manje često (1/1000 i <1/100), rijetko (1/10 000 i <1/1000), vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Now you are ready to dissolve the powder with the solvent.
Croatian: Sada ste spremni otopiti prašak s otapalom.
English: Efficacy and safety in all patients should be closely monitored on an ongoing basis according to clinical treatment guidelines.
Croatian: Učinkovitost i sigurnost kod svih bolesnika treba konstantno detaljno pratiti sukladno kliničkim smjernicama.
English: Dissolve the powder
Croatian: Otopite prašak
English: The antibody formation has not been associated with clinically relevant safety findings, reduced efficacy or changed pharmacokinetics of Revestive.
Croatian: Stvaranje antitijela nije bilo povezano s klinički značajnim sigurnosnim nalazima, smanjenjem djelotvornosti ili promijenjenom farmakokinetikom lijeka Revestive.
English: Teduglutide has a terminal elimination half-life of approximately 2 hours.
Croatian: Teduglutid ima terminalno poluvrijeme eliminacije od približno 2 sata.
English: Specifically, clearance decreases with increasing age from 1 year old to adults.
Croatian: Posebice se smanjuje klirens s porastom dobi od navršene 1 godine do odrasle dobi.
English: The objective was to evaluate safety/tolerability, pharmacokinetics and efficacy of teduglutide.
Croatian: Cilj je bio procijeniti sigurnost/podnošljivost, farmakokinetiku i djelotvornost teduglutida.
English: If you forget to inject this medicine (or cannot inject it at your usual time), use it as soon as possible on that day.
Croatian: Ako ste zaboravili primijeniti ovaj lijek (ili to ne možete učiniti u uobičajeno vrijeme), primijenite ga čim je moguće toga dana.
English: What Revestive is and what it is used for What you need to know before you use Revestive How to use Revestive
Croatian: Što je Revestive i za što se koristi Što morate znati prije nego počnete primjenjivati Revestive Kako primjenjivati Revestive
English: The safety and efficacy of Revestive in children below 1 year of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Revestive u djece mlađe od 1 godine nisu ustanovljene.
English: If you use more Revestive than you should
Croatian: Ako primijenite više lijeka Revestive nego što ste trebali
English: Bend your wrist back and quickly insert the needle at a 45° angle.
Croatian: Okrenite zglob prema nazad i brzo zabodite iglu pod kutom od 45°.
English: International Short Bowel Syndrome Registry Non-interventional study (NIS) to gather further safety data, in order to further elucidate the potential and identified risk as outlined in the RMP, based on a CHMP approved protocol.
Croatian: Međunarodni registar za sindrom kratkog crijeva Neintervencijsko ispitivanje za prikupljanje dodatnih podataka o sigurnosti s ciljem daljeg razjašnjavanja potencijala i identifikacije rizika kako je navedeno u RMP-u, na temelju protokola odobrenog od strane CHMP-a.
English: Any volume exceeding the prescribed dose in ml must be expelled and discarded.
Croatian: Volumen koji premašuje propisanu dozu u mililitrima treba istisnuti i odbaciti.
English: It is recommended that your doctor performs these examinations once a year during the first 2 years after starting treatment, and then at a minimum of five-year intervals.
Croatian: Taj se pregled preporučuje jednom godišnje tijekom prve dvije godine nakon početka liječenja, a zatim u razmacima od najmanje pet godina.
English: Limited data from clinical studies have shown that some patients may take longer to respond to treatment (i.e., those who still have presence of colon-in-continuity or distal/terminal ileum); if no overall improvement is achieved after 12 months, the need for continued treatment should be reconsidered.
Croatian: Ograničeni podaci iz kliničkih ispitivanja pokazali su da se u nekih bolesnika odgovor na liječenje može pojaviti i poslije toga vremena (npr. u onih s još prisutnim debelim crijevom u kontinuitetu ili distalnim/terminalnim ileumom); ako se ukupno poboljšanje ne postigne nakon 12 mjeseci, potrebu za nastavkom liječenja treba ponovno razmotriti.
English: Influenza-like illness
Croatian: bolest slična gripi
English: Reduction in parenteral nutrition volume
Croatian: Smanjenje volumena parenteralne prehrane
English: These studies included 101 patients in the following age groups: 5 patients 1-2 years, 56 patients 2 to <6 years, 32 patients 6 to <12 years, 7 patients 12 to <17 years, and 1 patient 17 to <18 years.
Croatian: Ova su ispitivanja uključila 101 bolesnika u sljedećim dobnim skupinama: 5 bolesnika u dobi od 1-2 godine, 56 bolesnika u dobi od 2 do < 6 godina, 32 bolesnika u dobi od 6 do < 12 godina, 7 bolesnika u dobi od 12 do <17 godina i 1 bolesnika u dobi od 17 do <18 godina.
English: Revestive is injected under the skin (subcutaneously) once daily.
Croatian: Revestive treba ubrizgati pod kožu (supkutano) jedanput dnevno.
English: Treatment should not be initiated until it is reasonable to assume that a patient is stable following a period of intestinal adaptation.
Croatian: Liječenje ne smije započeti sve dok se ne može razumno pretpostaviti da je bolesnik stabilan nakon razdoblja adaptacije crijeva.
English: Since teduglutide is a peptide it is likely that it follows the principal mechanism for peptide metabolism.
Croatian: S obzirom da je teduglutid peptid, vjerojatno slijedi načelni mehanizam metabolizma peptida.
English: In children below the age of two years, treatment should be evaluated after 12 weeks.
Croatian: U djece u dobi ispod dvije godine potrebno je procijeniti učinak liječenja nakon 12 tjedana.
English: If air bubbles are present, gently tap the syringe until they rise to the top.
Croatian: Ako su mjehurići zraka prisutni, lagano lupkajte prstom po štrcaljki dok se ne podignu na vrh.
English: Due to increased fluid absorption, patients with cardiovascular disease, such as cardiac insufficiency and hypertension, should be monitored with regard to fluid overload, especially during initiation of therapy.
Croatian: Zbog povećane apsorpcije tekućine, bolesnike s kardiovaskularnim bolestima poput insuficijencije srca i hipertenzije treba pratiti s obzirom na preopterećenje tekućinom, a naročito tijekom započinjanja terapije.
English: Clinical assessment by the physician should consider individual treatment objectives and patient preferences.
Croatian: Kliničke procjene liječnika trebaju uzeti u obzir i pojedinačne ciljeve liječenja i sklonosti bolesnika.
English: Unopened vials 4 years.
Croatian: Neotvorene bočice 4 godine
English: Final study report
Croatian: Završno izvješće ispitivanja
English: Approximately 38% of the treated patients with a stoma experienced gastrointestinal stoma complications.
Croatian: Približno 38% liječenih bolesnika sa stomom imalo je komplikacije gastrointestinale stome.