FrancophonIA/ELRC3.0 huggingface dataset:
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aranesp 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/suzdržati se od terapije lijekom Aranesp uzimajući u obzir dobrobit dojenja za dijete i korist terapije za ženu.
English: In the chronic toxicity studies no tumourigenic or unexpected mitogenic responses were observed in any tissue type.
Croatian: U ispitivanjima kronične toksičnosti nije zapažen tumorogeni ili neočekivan mitogeni odgovor kod bilo kojeg tipa tkiva.
English: If clinically indicated, phlebotomy may be performed.
Croatian: Ako je klinički indicirano, moguće je izvođenje flebotomije.
English: For instructions on use of the pre-filled pen, please read the section at the end of this leaflet.
Croatian: Za upute za upotrebu napunjene brizgalice, pročitajte dio na kraju ove upute.
English: Convulsions were common in the placebo groups.
Croatian: Konvulzije su bile česte u placebo grupama.
English: If it is cloudy or there are particles in it, you must not use it.
Croatian: Ako je mutna ili sadrži vidljive čestice, ne smijete je koristiti.
English: The primary efficacy endpoint [change in haemoglobin between baseline and the evaluation period (week 21-28)] was comparable between the two groups.
Croatian: Primarna mjera ishoda djelotvornosti [promjena u vrijednosti hemoglobina između početka ispitivanja i perioda procjene (tjedan 21-28)] bila je usporediva između dvije skupine.
English: Release button
Croatian: Otpustiti gumb
English: - Misuse by healthy people can cause life-threatening problems with the heart or blood vessels.
Croatian: - Pogrešna primjena u zdravih ljudi može izazvati po život opasne probleme sa srcem ili krvnim žilama.
English: Important: You must push all the way down but do not touch the red start button until you are ready to inject.
Croatian: Važno: Morate pritisnuti brizgalicu do kraja, ali nemojte dirati crveni gumb sve dok niste spremni injicirati.
English: The maximum amount of Aranesp that can be safely administered in single or multiple doses has not been determined.
Croatian: Maksimalna količina lijeka Aranesp koja se može sigurno primijeniti u pojedinačnoj ili višestrukim dozama nije određena.
English: Your healthcare professional should always record the exact product you are using.
Croatian: Vaš liječnik uvijek treba zabilježiti koji točno lijek uzimate.
English: • 0.75 micrograms once every two weeks, or
Croatian: • 0,75 mikrograma jednom svaka dva tjedna, ili
English: Your doctor may decide to change the way that your injection is given (either under the skin or into a vein).
Croatian: Liječnik može odlučiti promijeniti način davanja injekcije (ili potkožno ili u venu).
English: B Open the tray, peeling away the cover.
Croatian: B Otvorite podlogu skidanjem pokrova.
English: In order to correct your anaemia, your initial dose of Aranesp per kilogram of your body weight will be either:
Croatian: Da bi se korigirala anemija, početna doza lijeka Aranesp po kilogramu Vaše tjelesne težine će biti:
English: In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Croatian: U 4 placebom kontrolirana ispitivanja omjeri rizika ukupnog preživljenja su bili između 1,25 i 2,47 u korist kontrolne skupine.
English: Your doctor, nurse or pharmacist will tell you how much Aranesp you need and how frequently it should be injected.
Croatian: Vaš liječnik, medicinska sestra ili ljekarnik će Vam reći koliko Vam je lijeka Aranesp potrebno i koliko često ga trebate injicirati.
English: Anaemia is when your blood does not contain enough red blood cells and the symptoms may be fatigue, weakness and shortness of breath.
Croatian: Anemija je bolest kod koje krv ne sadrži dovoljno crvenih krvnih stanica i simptomi mogu biti umor, slabost i nedostatak zraka.
English: Your doctor will tell you exactly when to stop taking Aranesp.
Croatian: Liječnik će vas uputiti kad trebate prestati uzimati Aranesp.
English: If you experience these symptoms you should contact your doctor.
Croatian: Ukoliko primijetite ove simptome morate se obratiti Vašem liječniku.
English: • 0.45 micrograms once weekly.
Croatian: • 0,45 mikrograma jednom tjedno.
English: Special warnings: - If you have symptoms which include unusual tiredness and a lack of energy this could mean you have pure red cell aplasia (PRCA), which has been reported in patients.
Croatian: Posebna upozorenja: - Ako imate simptome koji uključuju neuobičajeni umor i nedostatak energije, to može značiti da imate izoliranu aplaziju crvenih krvnih stanica (PRCA) koja je primijećena kod bolesnika.
English: Other medicines and Aranesp
Croatian: Drugi lijekovi i Aranesp
English: • Outer area of upper arm (only if someone else is giving you the injection) Clean the injection site with an alcohol wipe.
Croatian: • Vanjska površina nadlaktice (samo ako vam netko drugi daje injekciju) Očistite mjesto injiciranja alkoholom.
English: You may change the injection site if you notice the area is red or sore.
Croatian: Možete promijeniti mjesto injiciranja ako primijetite crvenilo ili bol.
English: For more information or help, contact your healthcare provider.
Croatian: Za više informacija ili pomoć obratite se svom zdravstvenom radniku.
English: There are no adequate and well-controlled studies with Aranesp in pregnant women.
Croatian: Nema odgovarajućih i dobro kontroliranih ispitivanja s lijekom Aranesp kod trudnica.
English: Equipment:
Croatian: Pribor:
English: Aranesp has not been tested in pregnant women.
Croatian: Aranesp nije ispitivan u trudnica.
English: More severe cases have been observed with long-acting epoetins.
Croatian: Teži slučajevi primijećeni su kod dugodjelujućih epoetina.
English: Yellow window (injection complete)
Croatian: Žuti prozorčić (injiciranje završeno)
English: • Alcohol wipes
Croatian: • Alkoholne maramice
English: Cyclosporin and tacrolimus (medicines which suppress the immune system) may be affected by the number of red cells in your blood.
Croatian: Učinak ciklosporina i takrolimusa (lijekova koji potiskuju imunološki sustav) može biti promijenjen ovisno o broju crvenih krvnih stanica u Vašoj krvi.
English: Aranesp should not affect your ability to drive or use machinery.
Croatian: Aranesp ne bi trebao utjecati na vašu sposobnost vožnje i upravljanja strojevima.
English: How do you or the person injecting you, use the Aranesp pre-filled syringe?
Croatian: Kako ćete Vi ili osoba koja Vam injicira lijek, koristiti Aranesp napunjenu štrcaljku?
English: Never inject Aranesp into a vein yourself.
Croatian: Nikad sami ne injicirajte Aranesp u venu.
English: These included myelofibrosis and splenic hypertrophy as well as broadening of the ECG-QRS complex in dogs but no dysrhythmia and no effect on the QT interval were observed.
Croatian: To uključuje mijelofibrozu i hipertrofiju slezene te širenje EKG-QRS kompleksa u pasa, ali nisu zapaženi disritmija ni učinak na QT interval.
English: Darbepoetin alfa did not reveal any genotoxic potential nor did it have any effect on the proliferation of non-haematological cells in vitro or in vivo.
Croatian: Darbepoetin alfa nije pokazao genotoksični potencijal niti je imao učinak na proliferaciju nehematoloških stanica in vitro ili in vivo.
English: The additional sugar residues are molecularly indistinct from those on the endogenous hormone.
Croatian: Dodatni ostaci šećera molekularno se ne razlikuju od onih na endogenom hormonu.
English: Two of the studies recruited patients who were being treated with chemotherapy.
Croatian: Dvije od studija uključivale su bolesnike koji su bili liječeni kemoterapijom.
English: B Carefully pull the grey needle cap straight out and away from your body.
Croatian: B Pažljivo povucite sivi pokrov s igle u smjeru suprotnom od Vašeg tijela.
English: Push the plunger with a slow constant pressure, always keeping your skin pinched, until the syringe is empty.
Croatian: Gurajte klip polaganim, stalnim pritiskom, držeći pritom nabor kože, dok se štrcaljka ne isprazni.
English: Cases have been reported in patients with hepatitis C treated with interferon and ribavirin, when epoetins are used concomitantly.
Croatian: Prijavljeni su slučajevi kod bolesnika s hepatitisom C, liječenih interferonom i ribavirinom, kada su epoetini primjenjivani istodobno.
English: • High blood pressure (hypertension)
Croatian: • visoki krvni tlak (hipertenzija)
English: PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia.
Croatian: PRCA znači da je tijelo prestalo ili smanjilo stvaranje crvenih krvnih stanica što uzrokuje tešku anemiju.
English: Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 mcg/L or whose transferrin saturation is below 20%.
Croatian: Nadomjesna terapija željezom se preporučuje za sve bolesnike sa serumskim vrijednostima feritina ispod 100 μg/l ili kod kojih je saturacija transferinom ispod 20%.
English: If you are unable to inject, please contact your healthcare provider immediately.
Croatian: Ukoliko ne možete injicirati, odmah se obratite svom zdravstvenom radniku.
English: - If you have symptoms which include severe headache, drowsiness, confusion, problems with your eyesight, nausea, vomiting or fits (seizures), it could mean that you have very high blood pressure.
Croatian: - Ukoliko imate simptome koji uključuju jaku glavobolju, pospanost, smetenost, probleme s vidom, mučninu, povraćanje ili napadaje, to može značiti da imate vrlo visok krvni tlak.
English: If you want to stop using Aranesp, you should discuss it with your doctor first.
Croatian: Ako želite prestati primjenjivati Aranesp, prvo o tome razgovarajte s Vašim liječnikom.
English: Very common: may affect more than 1 in 10 people • Allergic reactions
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba • alergijske reakcije
English: Data presented from controlled studies included 1,357 patients, 766 who received Aranesp and 591 patients who received r-HuEPO.
Croatian: Prikazani su podaci iz kontroliranih ispitivanja koje su uključivale 1357 bolesnika, 766 koji su primali Aranesp i 591 bolesnika koji su primali r-HuEPO.
English: • Rash and/or redness of the skin
Croatian: • kožni osip i/ili crvenilo kože
English: Since the liver is thought to be the principal route of elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with liver disease.
Croatian: Budući da je jetra glavni put eliminacije darbepoetina alfa i r-HuEPO, Aranesp treba koristiti s oprezom kod bolesnika s bolešću jetre.
English: Your doctor has given you Aranesp (an anti-anaemic) to treat your anaemia.
Croatian: Liječnik Vam je propisao Aranesp (antianemik) za liječenje Vaše anemije.
English: • The used pre-filled syringe should be disposed of in accordance with local requirements.
Croatian: • Iskorištene napunjene štrcaljke treba ukloniti u skladu s lokalnim propisima.
English: There was an expected moderate (< 2 fold) increase in serum concentration as steady state was approached, but no unexpected accumulation upon repeated administration.
Croatian: Zabilježeno je očekivano umjereno (< 2 puta) povišenje u serumskoj koncentraciji nakon što se doseglo stanje dinamičke ravnoteže, ali nije bilo neočekivana nakupljanja nakon ponovne primjene.
English: Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
Croatian: Promjene doze u fazi održavanja ne smiju biti češće od svaka 2 tjedna.
English: The carton contains a package leaflet with the full instructions for use and handling.
Croatian: Kutija sadrži uputu o lijeku s cjelovitim uputama za uporabu i rukovanje.
English: Not known: frequency cannot be estimated from available data
Croatian: Nepoznato: učestalost se ne može procijentiti iz dostupnih podataka
English: Patients < 6 years of age may need higher doses for maintenance of haemoglobin than patients above that age.
Croatian: Bolesnici mlađi od 6 godina bi mogli bi trebati veće doze za održavanje hemoglobina od bolesnika starijih od 6 godina.
English: If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective.
Croatian: Ako je nakon devet tjedana klinički odgovor bolesnika (umor, hemoglobinski odgovor) neodgovarajući, daljnje liječenje najvjerojatnije neće biti učinkovito.
English: Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
Croatian: Faktori koje treba uzeti u obzir prilikom procjene trebaju uključivati tip tumora, kao i njegov stadij, stupanj anemije, očekivano trajanje života, okolinu u kojoj se bolesnik liječi i sklonosti bolesnika (vidjeti dio 5.1).
English: In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary.
Croatian: Da bi se osigurala učinkovita eritropoeza, za sve bolesnike mora se procijeniti stanje željeza prije i tijekom liječenja.
English: - If you are a cancer patient you should be aware that Aranesp may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Croatian: Ako bolujete od karcinoma, trebate znati da Aranesp može djelovati kao čimbenik rasta krvnih stanica, a u pojedinim okolnostima može imati negativan utjecaj na Vaš karcinom.
English: If it occurs, appropriate dose adjustment should be made as provided.
Croatian: Ako se to dogodi, potrebno je osigurati odgovarajuće prilagođavanje doze.
English: You may notice a small air bubble in the pre-filled syringe.
Croatian: Možda ćete zamijetiti male mjehuriće zraka u napunjenoj štrcaljki.
English: To give yourself an injection you will need:
Croatian: Za samoprimjenu injekcije trebate:
English: • Store the pre-filled pen in the refrigerator (2ºC - 8ºC).
Croatian: • Čuvajte napunjenu brizgalicu u hladnjaku (2ºC - 8ºC).
English: In controlled clinical studies, use of Aranesp and other ESAs have shown:
Croatian: U kontroliranim kliničkim ispitivanjima, primjena lijeka Aranesp i drugih LSE je pokazala:
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Croatian: Vaš liječnik će primijeniti najmanju učinkovitu dozu za kontrolu simptoma
English: If you need to use the same injection site, just make sure it is not the same spot on that site you used last time.
Croatian: Ukoliko morate upotrijebiti isto mjesto injiciranja, samo provjerite da to ne bude baš ista točka na tom mjestu u koju ste injicirali prošli put.
English: Non-response to therapy with Aranesp should prompt a search for causative factors.
Croatian: Izostanak odgovora na terapiju lijekom Aranesp mora potaknuti potragu za uzročnim faktorima.
English: Push all the way down through the snap.
Croatian: Gurajte dolje kroz škljocanje.
English: The best places to inject yourself are the top of your thighs and the abdomen.
Croatian: Najpogodnija mjesta za samoprimjenu injekcije su gornji dio bedara i trbuh.
English: Step 1: Prepare A Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
Croatian: Korak 1: Priprema A Izvadite podlogu napunjene štrcaljke iz pakiranja i prikupite pribor potreban za davanje injekcije: alkoholne maramice, pamučna vata ili komad gaze, flaster i spremnik za odlaganje oštrog otpada (nije uključeno).
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Croatian: Ispitivanja na životinjama ne ukazuju na izravan štetan učinak na trudnoću, embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj.
English: Treatment of paediatric patients younger than 1 year of age has not been studied in randomised clinical trials (see section 5.1).
Croatian: Liječenje pedijatrijskih bolesnika mlađih od 1 godine nije ispitano u randomiziranim kliničkim ispitivanjima (vidjeti dio 5.1).
English: The rashes may progress to widespread peeling of the skin and life-threatening complications.
Croatian: Osip može napredovati do ljuštenja većih područja kože i po život opasnih komplikacija.
English: Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Croatian: Kontrolirana klinička ispitivanja nisu pokazala značajnu korist koja bi se mogla pripisati primjeni epoetina kada su koncentracije hemoglobina povišene iznad razine potrebne za kontrolu simptoma anemije i da bi se izbjegla transfuzija krvi.
English: Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.
Croatian: Ne pokušavajte ugrijati štrcaljku korištenjem izvora topline kao što su vruća voda ili mikrovalna.
English: Important: It is important to keep your skin stretched or pinched while injecting.
Croatian: Važno: Važno je da držite kožu rastegnutom ili u naboru za vrijeme davanja injekcije.
English: Important: Follow your healthcare provider's instructions about selecting sites for injection appropriate to you and about changing the site for each injection.
Croatian: Važno: Slijedite upute svog zdravstvenog radnika o odabiru mjesta injiciranja koja su za Vas primjerena te o promjeni mjesta injiciranja svaki put kada si dajete novu injekciju.
English: In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
Croatian: U nekoliko kontroliranih ispitivanja epoetini nisu pokazali da poboljšavaju sveukupno preživljenje ili smanjuju rizik napredovanja tumora kod bolesnika s anemijom povezanom s rakom.
English: The route of injection is the same as with r-HuEPO but your doctor will tell you how much you should take, and when, and may adjust your dose if necessary.
Croatian: Put primjene injekcije isti je kao za r-HuEPO, ali će Vam liječnik odrediti dozu i vrijeme uzimanja te ako je potrebno može prilagoditi Vašu dozu.
English: Blood pressure should be monitored in all patients, particularly during initiation of Aranesp therapy.
Croatian: Potrebno je kontrolirati krvni tlak kod svih bolesnika, posebno kod uvođenja terapije lijekom Aranesp.
English: In these studies, no meaningful differences were identified between the safety profile for paediatric patients and that previously reported for adult patients (see section 4.8).
Croatian: U ovim ispitivanjima nisu identificirane značajne razlike između sigurnosnog profila za pedijatrijske bolesnike i onog prethodno ustanovljenog za odrasle bolesnike (vidjeti dio 4.8).
English: Any medicinal product remaining should be disposed of.
Croatian: Sav preostali lijek treba zbrinuti.
English: Yellow safety guard
Croatian: Žuti sigurnosni štitnik
English: In the Aranesp group, 83% were receiving dialysis and 17% were not receiving dialysis.
Croatian: U skupini koja je primala Aranesp, na dijalizi je bilo 83% bolesnika, dok 17% nije bilo na dijalizi.
English: Aranesp therapy should be discontinued approximately four weeks after the end of chemotherapy.
Croatian: Terapiju lijekom Aranesp treba prekinuti otprilike 4 tjedna nakon završetka kemoterapije.
English: INSERT the needle into skin.
Croatian: UVEDITE iglu u kožu.
English: Aranesp treatment should be initiated by physicians experienced in the above mentioned indications.
Croatian: Liječenje lijekom Aranesp mora započeti liječnik koji ima iskustva u gore navedenim indikacijama.
English: In patients with cancer receiving chemotherapy the etiology of anaemia is multifactorial.
Croatian: Kod bolesnika s rakom koji primaju kemoterapiju etiologija anemije je multifaktorijalna.
English: Clinical studies have demonstrated that darbepoetin alfa had similar effectiveness when administered as a single injection either once every three weeks, once every two weeks, or weekly without any increase in total dose requirements.
Croatian: Klinička ispitivanja pokazala su da je darbepoetin alfa imao sličnu učinkovitost kad je bio primijenjen kao jedna injekcija svaka 3 tjedna, svaka 2 tjedna ili tjedno bez ikakve potrebe za povećanjem ukupne doze.
English: Before you use an Aranesp pre-filled syringe with automatic needle guard, read this important information:
Croatian: Prije korištenja napunjene štrcaljke s automatskim štitnikom za iglu, pročitajte važne obavijesti:
English: What Aranesp is and what it is used for What you need to know before you use Aranesp How to use Aranesp
Croatian: Što je Aranesp i za što se koristi Što morate znati prije nego počnete primjenjivati Aranesp Kako primjenjivati Aranesp
English: Where the same sampling duration was used, observed pharmacokinetic data and population pharmacokinetic modelling demonstrated that the pharmacokinetics of darbepoetin alfa was similar for paediatric and adult patients with CRF.
Croatian: Kada je primijenjeno isto vrijeme uzorkovanja, opaženi farmakokinetički podaci i populacijsko farmakokinetičko modeliranje pokazali su da je farmakokinetika darbepoetina alfa bila slična za pedijatrijske i odrasle bolesnike s kroničnim zatajenjem bubrega.
English: Darbepoetin alfa has five N-linked carbohydrate chains whereas the endogenous hormone and recombinant human erythropoietins (r-HuEPO) have three.
Croatian: Darbepoetin alfa sastoji se od pet lanaca ugljikohidrata povezanih dušikom, a endogeni hormon i rekombinantni ljudski eritropoetin (r-HuEPO) imaju tri.
English: I When you are ready to inject, pressthe red start button.
Croatian: Kada ste spremni injicirati, pritisnitecrveni gumb.
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Croatian: Receptori eritropoetina mogu biti izraženi na površini različitih tumorskih stanica.
English: Because of individual variability, titration to optimal therapeutic doses is expected for individual patients.
Croatian: Zbog individualne varijabilnosti, treba titracijom odrediti optimalnu terapijsku dozu za svakog pojedinog bolesnika.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Croatian: Prilikom propisivanja lijeka bolesnike je potrebno savjetovati o znakovima i simptomima te pažljivo pratiti zbog mogućih reakcija na koži.
English: Aranesp may be administered subcutaneously by the patient or a carer after being trained by a doctor, nurse or pharmacist.
Croatian: Aranesp može supkutano primijeniti bolesnik ili skrbnik nakon što ga za to obuče liječnik, medicinska sestra ili ljekarnik.
English: Before you use the Aranesp SureClick pre-filled pen, read this important information: Storing your Aranesp SureClick pre-filled pens
Croatian: Prije korištenja Aranesp SureClick napunjene brizgalice, pročitajte važne obavijesti: Čuvanje Vaših Aranesp SureClick napunjenih brizgalica
English: Do not put the pre-filled pen back in the refrigerator once it has reached room temperature.
Croatian: Nemojte vraćati napunjenu brizgalicu natrag u hladnjak nakon što brizgalica dosegne sobnu temperaturu.
English: Do not use any Aranesp that is left in the syringe.
Croatian: Ne koristite Aranesp koji je ostao u štrcaljki.
English: If you do not respond adequately to Aranesp, your doctor will check your dose and will inform you if you need to change doses of Aranesp.
Croatian: Ako ne odgovarate adekvatno na liječenje lijekom Aranesp, Vaš liječnik će provjeriti Vašu dozu i obavijestiti Vas trebate li promijeniti doze lijeka Aranesp.