FrancophonIA/ELRC3.0 huggingface dataset:
English: • For adults and children Retacrit is given as an injection either into a vein (intravenously) or a tube that goes into a vein.
Croatian: • Odraslima i djeci Retacrit se daje u obliku injekcije u venu (intravenski) ili kroz cjevčicu koja ulazi u venu.
English: If blood pressure cannot be controlled, epoetin zeta treatment should be discontinued.
Croatian: Ako se krvni tlak ne može kontrolirati, primjenu epoetina zeta treba prekinuti.
English: Some people, depending on why they need Retacrit treatment, may later learn how to inject themselves under the skin: see Instructions on how to inject Retacrit yourself.
Croatian: Neke osobe, ovisno o razlogu zbog kojeg im je potrebno liječenje Retacritom, mogu kasnije naučiti sami sebi primjenjivati lijek pod kožu; pogledajte Upute za samostalnu primjenu injekcija Retacrita.
English: EPO is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors.
Croatian: Uključen je u sve faze razvoja eritrocita, a najvažnije djelovanje ima na razini eritrocitnih prekursora.
English: This medicine contains phenylalanine and may be harmful for people with phenylketonuria (genetic enzyme deficiency that increases excretion of a chemical (phenylketone) in urine and may cause nervous system disorders).
Croatian: Ovaj lijek sadrži fenilalanin i može biti štetan osobama s fenilketonurijom (genetski nedostatak enzima koji povećava izlučivanje kemikalije (fenilketona) u urin i koji može uzrokovati poremećaj živčanog sustava).
English: • Pinch a fold of skin between your thumb and index finger.
Croatian: • Uhvatite nabor kože između palca i kažiprsta.
English: Autologous predonation programme
Croatian: Program autologne predonacije
English: • Your doctor will order regular blood tests to see how your anaemia is responding and may adjust the dose, usually no more frequently than every four weeks.
Croatian: • Liječnik će tražiti da redovito obavljate pretrage krvi radi praćenja kako Vaša anemija odgovara na liječenje i možda će prilagoditi dozu, obično ne češće od svaka četiri tjedna.
English: Epoetin zeta should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Croatian: . Epoetin zeta treba primjenjivati s oprezom kod neliječene, neodgovarajuće liječene ili loše kontrolirane hipertenzije.
English: • Always use Retacrit exactly as instructed by your doctor or nurse.
Croatian: • Uvijek primijenite Retacrit točno onako kako su Vas podučili liječnik ili medicinska sestra.
English: This temperature range should be closely maintained until administration to the patient.
Croatian: Potrebno je pažljivo održavati ovaj temperaturni raspon sve do primjene u bolesnika.
English: If the product has been shaken vigorously, don't use it.
Croatian: Ako je lijek snažno protresen, nemojte ga primijeniti.
English: In cell cultures of human bone marrow cells, epoetin alfa stimulates erythropoiesis specifically and does not affect leucopoiesis.
Croatian: U staničnim kulturama ljudske koštane srži, epoetin alfa stimulira specifično eritropoezu i ne utječe na leukopoezu.
English: The safety and efficacy of epoetin alfa in paediatric patients receiving chemotherapy have not been established (see section 5.1).
Croatian: Sigurnost i djelotvornost epoetina alfa u pedijatrijskih bolesnika na kemoterapiji nisu ustanovljene (vidjeti dio 5.1).
English: • An increase in levels of small blood cells (called platelets), which are normally involved in the formation of a blood clot may occur, particularly when starting treatment.
Croatian: • može doći do povećanja razine malih krvnih stanica (nazvanih krvne pločice), koje su obično uključene u stvaranje krvnog ugruška, osobito na početku liječenja.
English: • If you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
Croatian: • ako se morate podvrgnuti velikoj planiranoj ortopedskoj operaciji (poput operacije kuka ili koljena), a:
English: If you are taking a medicine called cyclosporin (used e.g. after kidney transplants), your doctor may order blood tests to check the level of cyclosporin while you are taking Retacrit.
Croatian: Ako uzimate lijek koji se zove ciklosporin (koristi se npr. nakon transplantacije bubrega), liječnik može zatražiti krvne pretrage radi provjere razine ciklosporina dok primjenjujete Retacrit.
English: If you can't take medicines that prevent blood clotting, you must not have Retacrit.
Croatian: Ako ne smijeteuzimati lijekove koji sprječavaju stvaranje krvnih ugrušaka, ne smijete primati Retacrit.
English: How to inject yourself using a pre-filled syringe
Croatian: Kako sam sebi injicirati koristeći napunjenu štrcaljku
English: • Push the plunger with your thumb as far as it will go to inject the entire amount of liquid.
Croatian: • Potisnite klip sa svojim palcem koliko god ide kako biste injicirali cijelu tekućinu.
English: Precautions to be taken before handling or administering the medicinal product.
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja ili primjene lijeka:
English: Iron supplements and other blood stimulants may increase the effectiveness of Retacrit.
Croatian: Pripravci za nadoknadu željeza i drugi pripravci koji stimuliraju krv mogu povećati djelotvornost Retacrita.
English: • Swelling of the ankles, feet or fingers
Croatian: • oticanje gležnjeva, stopala ili prstiju
English: In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Retacrit subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Croatian: U slučajevima kada liječnik zaključi da bolesnik ili njegovatelj mogu sigurno i učinkovito sami davati Retacrit kao supkutanu injekciju, potrebno ih je poučiti o pravilnom doziranju i primjeni lijeka.
English: What Retacrit contains
Croatian: Što Retacrit sadrži
English: These changes are interpreted as being secondary to decreased maternal body weight gain, and the significance to humans is unknown given therapeutic dose levels.
Croatian: Smatra se da su te promjene sekundarne posljedice smanjenja tjelesne težine majke, a uzimajući u obzir razine terapijskih doza njihov značaj za ljude nije poznat.
English: • Either into a vein or a tube that goes into a vein (intravenously)
Croatian: • u venu ili kroz cjevčicu koja ulazi u venu (intravenski)
English: Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported.
Croatian: Osim toga, zabilježeni su cerebrovaskularni incidenti (uključujući cerebralni infarkt, cerebralnu hemoragiju i tranzitorne ishemijske atake).
English: You may take Retacrit out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days.
Croatian: Retacrit možete izvaditi iz hladnjaka i čuvati ga na sobnoj temperaturi (do 25°C), ali ne dulje od 3 dana.
English: • Blood clots (including deep vein thrombosis and embolism) that may require urgent treatment.
Croatian: • krvni ugrušci (uključujući duboku vensku trombozu i emboliju) koji mogu zahtijevati hitno liječenje.
English: Tell your doctor or nurse immediately if you notice any of the effects in this list.
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako primijetite bilo koji učinak s ovog popisa.
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 se koncentracija hemoglobina povećala iznad razine potrebne za kontrolu simptoma anemije i izbjegavanje transfuzija krvi.
English: Of the patients who achieved the target, 90% did so on a 3 times-per-week dosing regimen.
Croatian: Od bolesnika koji su postigli ciljnu vrijednost, 90% bolesnika postiglo je to pri režimu doziranja 3 puta tjedno.
English: Overdosage of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
Croatian: Predoziranje eritropoetinom može izazvati učinak koji se nadovezuje na farmakološki učinak hormona.
English: In controlled clinical studies, use of epoetin zeta and other ESAs have been associated with decreased locoregional tumour control or decreased overall survival:
Croatian: U kontroliranim kliničkim ispitivanjima primjena epoetina zeta i drugih ESA lijekova bila je povezana sa smanjenom lokoregionalnom kontrolom tumora ili skraćenim ukupnim preživljenjem:
English: Later, your doctor may suggest that you or your caregiver learn how to inject Retacrit under the skin (subcutaneously) yourself.
Croatian: Kasnije Vam liječnik može predložiti da Vi ili Vaš njegovatelj naučite kako da sami primjenjujete Retacrit injekcijom pod kožu (supkutano).
English: You may still be able to use Retacrit, but discuss it with your doctor first:
Croatian: Možda ćete ipak moći primati Retacrit, ali najprije se posavjetujte o tome sa svojim liječnikom:
English: A maximum volume of 1 mL at one injection site should generally not be exceeded.
Croatian: U pravilu se ne smije prekoračiti maksimalni volumen od 1 ml po jednom mjestu injiciranja.
English: Patients from the group treated with epoetin alfa were also enrolled in an open-label extension study which demonstrated improvements in their quality of life that were maintained for an additional 12 months.
Croatian: Bolesnici iz skupine liječene epoetinom alfa bili su uključeni i u otvoreni produžetak ispitivanja kojim se pokazalo da su se poboljšanja u kvaliteti života tih bolesnika održala još dodatnih 12 mjeseci.
English: • if any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister,
Croatian: • ako je tekućina curila iz napunjene štrcaljke ili se vidi kondenzacija unutar zatvorenog blistera
English: When this access (via a vein or tube) is not readily available, your doctor may decide that Retacrit should be injected under the skin (subcutaneously).
Croatian: Ako taj pristup (putem vene ili cjevčice) nije lako dostupan, liječnik može odlučiti da Retacrit treba injicirati pod kožu (supkutano).
English: • Retacrit is given by injection under the skin.
Croatian: • Retacrit se daje injekcijom pod kožu.
English: The median time to target was 11 weeks and the median dose at target was 150 IU/kg/week.
Croatian: Medijan vremena do postizanja ciljne vrijednosti bio je 11 tjedana, a medijan doze pri ciljnoj vrijednosti iznosio je 150 IU/kg tjedno.
English: Retacrit contains phenylalanine
Croatian: Retacrit sadrži fenilalanin
English: Usually the injections will be given to you by a doctor, nurse or other health care professional.
Croatian: Obično injekcije daje liječnik, medicinska sestra ili drugi zdravstveni radnik.
English: In clinical trials at starting doses of 50 to 150 IU/kg, three times per week, approximately 95% of all patients responded with a clinically significant increase in haematocrit.
Croatian: U kliničkim ispitivanjima u kojima su početne doze od 50 do 150 IU/kg primjenjivane tri puta tjedno, približno 95% svih bolesnika odgovorilo je klinički značajnim povećanjem hematokrita.
English: If possible, iron supplementation should be initiated prior to starting epoetin zeta therapy to achieve adequate iron stores.
Croatian: Ako je moguće, s nadoknadom željeza treba započeti prije uvođenja terapije epoetinom zeta kako bi se osigurale odgovarajuće zalihe željeza.
English: Do not use Retacrit:
Croatian: Nemojte uzimati Retacrit:
English: If signs and symptoms suggestive of these reactions appear, Retacrit should be withdrawn immediately and an alternative treatment considered.
Croatian: Ako se razviju znakovi i simptomi koji ukazuju na te reakcije, primjenu Retacrita treba odmah prekinuti i razmisliti o zamijenskom liječenju.
English: You may still be able to use Retacrit, but discuss it with your doctor first.
Croatian: Možda ćete ipak moći primati Retacrit, ali najprije o tome razgovarajte s liječnikom.
English: More severe cases have been observed with long-acting epoetins.
Croatian: Teži slučajevi opaženi su kod primjene dugodjelujućih epoetina.
English: Treatment with Retacrit has to be initiated under the supervision of physicians experienced in the management of patients with above indications.
Croatian: Liječenje Retacritom treba započeti pod nadzorom liječnika s iskustvom u liječenju bolesnika s gore navedenim indikacijama.
English: Retacrit is indicated in adults in a predonation programme to increase the yield of autologous blood.
Croatian: Retacrit je indiciran u odraslih u predonacijskom programu radi povećanja količine autologne krvi.
English: Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur.
Croatian: Osim toga, mogu se pojaviti ranice u ustima, grlu, nosu, na spolovilu i očima (crvene i otečene oči).
English: The needle-trap requires specific actions by the user to “activate” it, which will render the needle harmless after the injection is administered.
Croatian: Kako bi se klopka za iglu ''aktivirala'' od korisnika se zahtijevaju određene radnje koje će iglu učiniti bezopasnom nakon primjene injekcije:
English: • If you do not respond adequately to Retacrit, your doctor will check your dose and will inform you if you need to change doses of Retacrit.
Croatian: • Ako ne budete odgovarali na liječenje Retacritom na odgovarajući način, liječnik će provjeriti Vašu dozu i reći je li Vam potrebno promijeniti doze Retacrita.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: • If you are a cancer patient be aware that products that stimulate red blood cell production (like Retacrit) may act as a growth factor and therefore in theory may affect the progression of your cancer.
Croatian: • Ako bolujete od raka, morate znati da lijekovi koji potiču stvaranje crvenih krvnih stanica (kao što je Retacrit) mogu djelovati kao čimbenik rasta, pa tako u teoriji mogu utjecati na napredovanje raka od kojeg bolujete.
English: • Retacrit is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Croatian: • Retacrit se daje injekcijom pod kožu svakog tjedna tijekom tri tjedna prije operacije i na dan operacije.
English: • If you are a patient with chronic renal failure, and particularly if you do not respond properly to Retacrit, your doctor will check your dose of Retacrit because repeatedly increasing your dose of Retacrit if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death.
Croatian: • Ako ste bolesnik s kroničnim zatajenjem bubrega, a osobito ako na Retacrit ne reagirate zadovoljavajuće, liječnik će provjeriti Vašu dozu Retacrita jer ponavljano povećanje doze Retacrita, ako ne odgovarate na liječenje, može povećati rizik od pojave tegoba sa srcem ili krvnim žilama te može povećati rizik od srčanog udara, moždanog udara i smrti.
English: Epoetin alfa does not induce bacterial gene mutation (Ames Test), chromosomal aberrations in mammalian cells, micronuclei in mice, or gene mutation at the HGPRT locus.
Croatian: Epoetin alfa ne izaziva mutaciju bakterijskih gena (Amesov test), aberaciju kromosoma u stanicama sisavaca, mikronukleusa u miševa ili mutaciju gen a na HGPRT lokusu.
English: Your Retacrit dose and frequency of administration may be further adjusted to maintain your response to treatment.
Croatian: Doza Retacrita koju primate i učestalost primjene mogu se dodatno prilagođavati kako bi se održao Vaš odgovor na liječenje.
English: Conflicting reports in the literature, based on in vitro findings from human tumour samples, suggest erythropoietins may play a role as tumour proliferators.
Croatian: Proturječna izvješća u literaturi koja se temelje na in vitro nalazima iz uzoraka tumora u ljudi, upućuju na moguću ulogu eritropoetina kao proliferatora tumora.
English: Retacrit therapy should continue until one month after the end of chemotherapy.
Croatian: Terapiju Retacritom treba nastaviti još mjesec dana nakon završetka kemoterapije.
English: Survival and tumour progression have been examined in five large controlled studies involving a total of 2 833 patients, of which four were double-blind placebo-controlled studies and one was an open-label study.
Croatian: Preživljenje i progresija tumora ispitivani su u pet velikih kontroliranih ispitivanja s ukupno 2833 bolesnika, pri čemu su četiri bila dvostruko slijepa, placebom kontrolirana ispitivanja, a jedno je bilo otvoreno ispitivanje.
English: A patient-level data analysis has also been performed on more than 13 900 cancer patients (chemo-, radio-, chemoradio-, or no therapy) participating in 53 controlled clinical trials involving several epoetins.
Croatian: Provedena je i analiza podataka na razini bolesnika za više od 13 900 onkoloških bolesnika (kemoterapija, radioterapija, kemoradioterapija ili bez ikakve terapije) koji su sudjelovali u 53 kontrolirana klinička ispitivanja nekoliko epoetina.
English: • Never put used syringes into your normal household waste bin.
Croatian: • Nikada nemojte bacati štrcaljku u kućni otpad.
English: Epoetin alfa therapy reduced the risk of exposure to allogeneic blood by 50% compared to patients not receiving epoetin alfa.
Croatian: Terapija epoetinom alfa smanjila je rizik od izloženosti alogenoj krvi za 50% u odnosu na bolesnike koji nisu primali epoetin alfa.
English: In order to improve the traceability of ESAs, the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file.
Croatian: Kako bi se poboljšala sljedivost ESA lijekova, naziv i broj serije primijenjenog ESA lijeka potrebno je jasno zabilježiti (ili navesti) u bolesnikovojmedicinskoj dokumentaciji.
English: In all patients receiving epoetin zeta, blood pressure should be closely monitored and controlled as necessary.
Croatian: U svih bolesnika koji primaju epoetin zeta, potrebno je pomno nadzirati krvni tlak i po potrebi ga kontrolirati
English: The following maintenance doses were observed in clinical trials after 6 months of treatment.
Croatian: U kliničkim ispitivanjima, nakon 6 mjeseci liječenja opažene su sljedeće doze održavanja.
English: This is characterised by a sustained decrease in haemoglobin despite an increase in epoetin zeta dosage (see section 4.8).
Croatian: To se očituje stalnim snižavanjem vrijednosti hemoglobina unatoč povećanju doze epoetina zeta (vidjeti dio 4.8).
English: Bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
Croatian: Fibroza koštane srži poznata je komplikacija kroničnog zatajenja bubrega u čovjeka i može biti povezana sa sekundarnim hiperparatireoidizmom ili nepoznatim čimbenicima.
English: Take special care with other products that stimulate red blood cell production:
Croatian: Treba biti posebno oprezan s drugim lijekovima koji stimuliraju stvaranje crvenih krvnih stanica:
English: Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Croatian: Eritropoetinski receptori mogu biti prisutni na površini različith tumorskih stanica.
English: Once the target haematocrit was achieved, the maintenance dose was individualised for each patient.
Croatian: Kada je dosegnuta ciljna vrijednost hematokrita, za svakog je bolesnika određena individualna doza održavanja.
English: In some studies, the double-blind phase was followed by an open-label phase during which all patients received epoetin alfa and a maintenance of effect was observed.
Croatian: U nekim ispitivanjima, u kojima je nakon dvostruko slijepe faze slijedila faza otvorenog ispitivanja u kojoj su svi bolesnici primali epoetin alfa, opaženo je održavanje učinka.
English: Dose (IU/kg given 3 times per week)
Croatian: Doza (IU/kg primijenjena 3 puta tjedno)
English: Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Croatian: Ishod ukupnog preživljenja u ispitivanjima nije bilo moguće zadovoljavajuće objasniti razlikama u incidenciji tromboze i s njom povezanim komplikacijama između onih koji su primali rekombinantni ljudski eritropoetin i onih u kontrolnoj skupini.
English: Retacrit should not be used:
Croatian: Retacrit se ne smije upotrijebiti:
English: The first evidence of a response to epoetin alfa is an increase in the reticulocyte count within 10 days, followed by increases in the red cell count, haemoglobin and haematocrit, usually within 2 to 6 weeks.
Croatian: Prvi je dokaz odgovora na epoetin alfa porast broja retikulocita unutar 10 dana, praćen porastom broja crvenih krvnih stanica, hemoglobina i hematokrita obično unutar 2 do 6 tjedana.
English: The decision to administer recombinant erythropoietin treatment should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
Croatian: Odluku o liječenju rekombinantnim eritropoetinima treba temeljiti na procjeni omjera koristi i rizika uz sudjelovanje pojedinog bolesnika, pri čemu treba uzeti u obzir i specifične kliničke okolnosti.
English: INTERMEDIATE CARTON (WITHOUT BLUE BOX) COMPONENT OF MULTIPACK
Croatian: UNUTARNJA KUTIJA (BEZ PLAVOG OKVIRA) SASTAVNI DIO VIŠESTRUKOG PAKIRANJA
English: Your doctor will use the lowest effective dose to control the symptoms of your anemia.
Croatian: Liječnik će Vam primjenjivati najnižu učinkovitu dozu za kontrolu simptoma anemije.
English: • Retacrit is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
Croatian: • Retacrit ćete primiti injekcijom u venu neposredno nakon postupka davanja krvi tijekom 3 tjedna prije Vaše operacije.
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek primijenite Retacrit točno onako kako Vam je rekao liječnik.
English: The erythropoietic response observed in both treatment groups resulted in similar transfusion rates (16% in the 600 IU/kg weekly group and 20% in the 300 IU/kg daily group).
Croatian: Eritropoetski odgovor opažen u obje terapijske skupine rezultirao je sličnim stopama transfuzije (16% u skupini koja je primala 600 IU/kg tjedno i 20% u skupini koja je primala 300 IU/kg dnevno).
English: While on Retacrit, some people need medicines to reduce the risk of blood clots.
Croatian: Kada primaju Retacrit, nekim su osobama potrebni lijekovi koji smanjuju rizik od krvnih ugrušaka.
English: This includes patients on dialysis and patients not yet on dialysis.
Croatian: To se odnosi na bolesnike na dijalizi i na bolesnike koji još nisu na dijalizi.
English: • High levels of blood potassium which can cause abnormal heart rhythm (this is a very common side effect in patients on dialysis).
Croatian: • visoka razina kalija u krvi koja može uzrokovati neuobičajeni srčani ritam (to je vrlo česta nuspojava u bolesnika na dijalizi)
English: Retacrit should be administered as a subcutaneous injection.
Croatian: Retacrit treba primjenjivati kao supkutanu injekciju.
English: After EPO binds to its cell surface receptor, it activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation.
Croatian: Nakon što se veže na površinski receptor stanice, eritropoetin aktivira signalne putove transdukcije koji koče apoptozu i stimulira proliferaciju eritroidnih stanica.