FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell the doctor or nurse immediately if you think too much Retacrit has been injected.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako mislite da ste primijenili previše Retacrita.
English: • If you have been diagnosed with Pure Red Cell Aplasia (the bone marrow cannot produce enough red blood cells) after previous treatment with any product that stimulates red blood cell production (including Retacrit).
Croatian: • ako Vam je dijagnosticirana izolirana aplazija crvene krvne loze (koštana srž ne može stvarati dovoljno crvenih krvnih stanica) nakon prethodnog liječenja bilo kojim lijekom koji potiče stvaranje crvenih krvnih stanica (uključujući Retacrit).
English: • Severe allergic reaction that may include: o a swollen face, lips, mouth, tongue or throat o difficulty swallowing or breathing o itchy rash (hives).
Croatian: • teške alergijske reakcije koje mogu uključivati: o otečenost lica, usana, usta, jezika ili grla o otežano gutanje ili disanje o kožni osip koji svrbi (koprivnjača)
English: Tell your doctor or nurse immediately if you are aware of any of these effects, or if you notice any other effects while you are receiving treatment with Retacrit.
Croatian: Odmah recite svom liječniku ili medicinskoj sestri ako ste primijetili bilo koji od ovih događaja ili ako ste primijetili bilo koje učinke dok primate liječenje Retacritom.
English: The prefilled syringes contain between 0.3 and 1 ml solution, depending on the content of epoetin zeta (see “What Retacrit contains”).
Croatian: Napunjene štrcaljke sadrže između 0,3 i 1 ml otopine, ovisno o sadržaju epoetina zeta (pogledajte ˝Što Retacrit sadrži˝).
English: Antibody-mediated pure red cell aplasia has been very rarely reported in <1/10 000 cases per patient year after months to years of treatment with epoetins (see section 4.4).
Croatian: Protutijelima posredovana izolirana aplazija crvene krvne loze prijavljena je vrlo rijetko u < 1/10 000 slučajeva po bolesniku-godina nakon više mjeseci ili godina liječenja epoetinima (vidjeti dio 4.4).
English: • Do not hold by the plunger head, plunger or needle cover.
Croatian: • Ne držite za vrh klipa, klip ili pokrov igle.
English: If you are within a day of your next injection, forget the missed one and carry on with your normal schedule.
Croatian: Međutim, ako ste zaboravili primijeniti injekciju, a Vaša sljedeća redovna injekcija trebabiti unutar razdoblja od jednog dana, nemojte primijeniti propuštenu injekciju nego nastavite primjenu prema svom uobičajenom rasporedu.
English: • You may be given iron supplements before and during Retacrit treatment to make it more effective.
Croatian: • Možda ćete uzimati i pripravke za nadoknadu željeza prije i za vrijeme liječenja Retacritom da bi se povećala njegova učinkovitost.
English: • To stimulate the production of your red blood cells (so that doctors can take more blood from you) if you cannot have transfusions with your own blood during or after surgery.
Croatian: • radi poticanja stvaranja crvenih krvnih stanica (kako biste mogli dati veću količinu krvi) ako ne možete primati transfuzije svoje krvi tijekom ili poslije operacije
English: Don't squeeze it.
Croatian: Nemojte ga stiskati.
English: If you forget to use Retacrit
Croatian: Ako ste zaboravili primijeniti Retacrit
English: • after the expiry date on the label and outer carton
Croatian: • nakon datuma roka valjanosti na naljepnici i kutiji
English: If you have kidney disease, you may be short of red blood cells if your kidney does not produce enough erythropoietin (necessary for red cell production).
Croatian: Ako imate bolest bubrega, moguće je da nemate dovoljno crvenih krvnih stanica ako Vam bubrezi ne proizvode dovoljno eritropoetina (potreban je za proizvodnju crvenih krvnih stanica).
English: • have severe disorders of the veins and arteries
Croatian: • imate teške poremećaje vena i arterija
English: Hamster Ovary (CHO) cell line).
Croatian: Chinese Hamster Ovary [CHO]).
English: • Your doctor may initiate treatment with Retacrit if your haemoglobin is 10 g/dL or less.
Croatian: • Liječnik može započeti liječenje Retacritom ako Vam je vrijednost hemoglobina 10 g/dl ili manje.
English: A randomized prospective trial (CHOIR) evaluated 1,432 anaemic chronic renal failure patients who were not undergoing dialysis.
Croatian: U randomiziranom prospektivnom ispitivanju (CHOIR) procijenjena su 1432 anemična bolesnika s kroničnim zatajenjem bubrega koji nisu bili podvrgnuti dijalizi.
English: Once the haemoglobin level is <11 g/dL the dose can be restarted on the same dosing step or one dosing step down based on physician judgement.
Croatian: Kada se razina hemoglobina vrati na < 11 g/dl, doziranje se može nastaviti istom dozom ili smanjenjem doze za jedan dozni korak, na temelju procjene liječnika.
English: In animal studies, epoetin alfa has been shown to decrease foetal body weight, delay ossification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose.
Croatian: Ispitivanja na životinjama pokazala su da epoetin alfa smanjuje tjelesnu težinu fetusa, usporava okoštavanje i povećava fetalnu smrtnost kad se primjenjuje u tjednoj dozi približno 20 puta većoj od preporučene tjedne doze za ljude.
English: Erythropoietins exhibit a dose-related effect on haematological parameters which is independent of route of administration.
Croatian: Eritropoetini pokazuju o dozi ovisan učinak na hematološke parametre, koji ne ovisi o putu primjene.
English: In repeated dose toxicological studies in dogs and rats, but not in monkeys, epoetin alfa therapy was associated with subclinical bone marrow fibrosis.
Croatian: U ispitivanjima toksičnosti ponovljenih doza provedenima na psima i štakorima, ali ne i na majmunima, terapija epoetinom alfa bila je povezana sa subkliničkom fibrozom koštane srži.
English: • If you are having dialysis treatment when you begin treatment with Retacrit, your dialysis regime may need to be adjusted.
Croatian: • Ako ste u vrijeme početka liječenja Retacritom na terapiji dijalizom, možda će biti potrebno prilagoditi Vaš režim dijalize.
English: • You will usually continue Retacrit treatment for one month after the end of chemotherapy.
Croatian: • Uobičajeno je nastaviti liječenje Retacritom još mjesec dana nakon završetka kemoterapije.
English: • in adults on haemodialysis or peritoneal dialysis.
Croatian: • u odraslih na hemodijalizi ili peritonejskoj dijalizi
English: In female adult patients with metastatic breast cancer, subcutaneous co-administration of 40 000 IU/mL epoetin alfa with trastuzumab 6 mg/kg had no effect on the pharmacokinetics of trastuzumab.
Croatian: U odraslih bolesnica s metastatskim rakom dojke, istodobna supkutana primjena 40 000 IU/ml epoetina alfa i 6 mg/kg trastuzumaba nije utjecala na farmakokinetiku trastuzumaba.
English: A tendency towards increased risk estimates for all-cause mortality, cardiovascular and cerebrovascular events associated with higher cumulative ESA doses independent of the diabetes or dialysis status was observed (see sections 4.2 and 4.4).
Croatian: Opažena je tendencija povećanja procijenjenog rizika od smrtnosti bilo kojeg uzroka, rizika od kardiovaskularnih i cerebrovaskularnih događaja povezanih s višim kumulativnim dozama ESA lijeka neovisno o dijabetesu ili statusu dijalize (vidjeti dijelove 4.2 i 4.4).
English: Retacrit has no or negligible influence on the ability to drive and use machines.
Croatian: Retacrit ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Hyperkalaemia has been observed in isolated cases though causality has not been established.
Croatian: U izoliranim slučajevima opažena je hiperkalijemija, iako uzročno posljedična povezanost nije utvrđena.
English: • Flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, chills,
Croatian: • simptomi nalik gripi poput glavobolje, bolovi i probadanje u zglobovima, osjećaja slabosti,
English: Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal (see section 4.4).
Croatian: Posebnu pozornost treba obratiti na iznenadne probadajuće glavobolje nalik migreni kao mogućem znaku upozorenja (vidjeti dio 4.4).
English: There are no studies assessing the potential effect of epoetin zeta on male or female fertility.
Croatian: Nema ispitivanja koja procjenjuju mogući učinak epoetina zeta na plodnost u muškaraca i žena.
English: Patients should only be switched from one ESA to another under appropriate supervision.
Croatian: Bolesnicima se jedan ESA lijek smije zamijeniti drugiim ESA lijekom samo pod odgovarajućim nadzorom.
English: Erythropoietin (EPO) is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production.
Croatian: Eritropoetin je glikoproteinski hormon koji se primarno proizvodi u bubrezima kao odgovor na hipoksiju i ključni je regulator proizvodnje crvenih krvnih stanica.
English: Adults with myelodysplastic syndrome
Croatian: Odrasli s mijelodisplastičnim sindromom
English: • If you are a cancer patient, be aware that use of Retacrit may be associated with shorter survival and a higher death rate in head and neck, and metastatic breast cancer patients who are receiving chemotherapy.
Croatian: • Ako bolujete od raka, morate znati da primjena Retacrita može biti povezana s kraćim preživljenjem i većom stopom smrtnosti u bolesnika s rakom glave i vrata i metastatskim rakom dojke koji primaju kemoterapiju.
English: Following subcutaneous injection, serum levels of erythropoietin reach a peak between 12 and 18 hours post-dose.
Croatian: Nakon supkutane injekcije razina eritropoetina u serumu doseže vrhunac 12 - 18 sati nakon primjene lijeka.
English: Moreover, in patients with a baseline haemoglobin of >13 g/dL (>8.1 mmol/L), the possibility that epoetin zeta treatment may be associated with an increased risk of postoperative thrombotic/vascular events cannot be excluded.
Croatian: Štoviše, u bolesnika s početnom razinom hemoglobina > 13 g/dl (> 8,1 mmol/l), ne smije se isključiti mogućnost da liječenje epoetinom zeta može biti povezano s povećanim rizikom od postoperativnih trombotičkih/vaskularnih događaja.
English: In the 20-week study (n=225), no significant difference was observed in the primary efficacy endpoint, i.e. the proportion of patients who required a RBC transfusion after Day 28 (62% of epoetin alfa patients versus 69% of standard therapy patients).
Croatian: U 20-tjednom ispitivanju (n = 225) nije bila opažena značajna razlika u primarnoj mjeri ishoda djelotvornosti, tj. u udjelu bolesnika kojima je bila potrebna transfuzija crvenih krvnih stanica nakon 28. dana (62% bolesnika liječena epoetinom alfa naspram 69% bolesnika liječenih standardnom terapijom).
English: • Let go of the plunger and allow the syringe to move up until the entire needle is guarded and locks into place.
Croatian: • Otpustite pritisak na klip i dopustite štrcaljki da klizne prema gore sve dok štitnik ne prekrije cijelu iglu i čvrsto sjedne na mjesto.
English: Phlebotomy may be performed if excessively high haemoglobin levels occur.
Croatian: Može se napraviti flebotomija ako dođe do izuzetno visoke razine hemoglobina.
English: You should discuss this with your doctor because a combination of epoetin zeta with interferon and ribavirin has led to a loss of effect and development of a condition called pure red cell aplasia (PRCA), a severe form of anaemia, in rare cases.
Croatian: U tom slučaju razgovarajte s liječnikom jer je kombinacija epoetina zeta s interferonom i ribavirinom dovela do gubitka učinka, a u rijetkim slučajevima i do razvoja stanja koje se naziva izolirana aplazija crvene krvne loze, što je teški oblik anemije.
English: In the three largest clinical trials conducted in adult patients on dialysis, the median maintenance dose necessary to maintain the haematocrit between 30 to 36% was approximately 75 IU/kg given 3 times per week.
Croatian: U tri najveća klinička ispitivanja provedena u odraslih bolesnika na dijalizi, medijan doze održavanja potrebne da se vrijednost hematokrita održi između 30 i 36% bio je otprilike 75 IU/kg s primjenom 3 puta tjedno.
English: Dose should not be increased over the maximum of 1 050 IU/kg (total dose 80 000 IU) per week.
Croatian: Dozu se ne smije povećati iznad maksimalne doze od 1050 IU/kg (ukupna doza iznosi 80 000 IU) na tjedan.
English: In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the concentration range for the indication of use.
Croatian: U svih bolesnika treba pomno pratiti razinu hemoglobina zbog potencijalno povećanog rizika od tromboembolijskih događaja i smrtnog ishoda kada liječeni bolesnici imaju razinu hemoglobina iznad raspona koncentracije u indikaciji za primjenu lijeka.
English: Retacrit contains the active substance epoetin zeta - a protein that stimulates the bone marrow to produce more red blood cells which carry haemoglobin (a substance that transports oxygen).
Croatian: Retacrit sadrži djelatnu tvar epoetin zeta - protein koji stimulira koštanu srž da stvara više crvenih krvnih stanica koje nose hemoglobin (tvar koja prenosi kisik).
English: In haemodialysed patients, a bolus injection may be given during the dialysis session through a suitable venous port in the dialysis line.
Croatian: U bolesnika na hemodijalizi moguća je primjena kao bolus injekcija tijekom samog postupka dijalize putem odgovarajućeg venskog porta na liniji za dijalizu.
English: Where intravenous access is not readily available (patients not yet undergoing dialysis and peritoneal dialysis patients) Retacrit may be administered as a subcutaneous injection.
Croatian: Kada intravenski pristup nije lako dostupan (bolesnici koji još nisu započeli s dijalizom i bolesnici na peritonejskoj dijalizi), Retacrit se može primjenjivati kao supkutana injekcija.
English: One pack contains 1, 4 or 6 pre-filled syringes with or without a needle guard or needle-trap device.
Croatian: Jedno pakiranje sadrži 1, 4 ili 6 napunjenih štrcaljki sa ili bez štitnika za iglu ili s klopkom za iglu.
English: In addition, thrombocythaemia above the normal range has been reported.
Croatian: Osim toga, zabilježena je i trombocitemija iznad normalnog raspona.
English: These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Croatian: Ove reakcije mogu se pojaviti u obliku crvenkastih mrlja nalik na metu ili u obliku okruglih područja, često sa središnjim mjehurićima na trupu, te kao ljuštenje kože, ranice u ustima, grlu, nosu, na spolovilu i očima, a mogu im prethoditi vrućica i/ili simptomi nalik gripi.
English: The injections should be given in the limbs or the anterior abdominal wall.
Croatian: Injekcije treba davati u područje udova ili prednje trbušne stijenke.
English: A bone marrow examination should also be considered for diagnosis of PRCA.
Croatian: Potrebno je razmotriti i pretragukoštane srži radi dijagnoze PRCA-e.
English: Caution should be exercised with escalation of Retacrit doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Croatian: Potreban je oprez kada se bolesnicima s kroničnim zatajenjem bubrega povećava doza Retacrita, jer visoke kumulativne doze epoetina mogu biti povezane s povišenim rizikom od smrtnosti i ozbiljnih kardiovaskularnih i cerebrovaskularnih događaja.
English: The use of Retacrit in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Croatian: Primjena Retacrita u bolesnika predviđenih za veliki elektivni ortopedski kirurški zahvat koji ne sudjeluju u programu autologne predonacije kontraindicirana je ako ti isti bolesnici imaju tešku bolest koronarnih arterija, perifernih arterija, karotida ili cerebrovaskularnu bolest, uključujući bolesnike s nedavnim infarktom miokarda ili cerebrovaskularnim incidentom.
English: Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal (see section 4.8).
Croatian: Posebnu pozornost treba obratiti na iznenadne probadajuće glavobolje nalik migreni kao mogući znak upozorenja (vidjeti dio 4.8).
English: These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Croatian: Ta su ispitivanja pokazala dosljednu i neobjašnjivu, statistički značajno veću smrtnost u bolesnika koji su imali anemiju povezanu s različitim čestim vrstama raka i primali rekombinantni ljudski eritropoetin od one u kontrolnih bolesnika.
English: If you develop a serious rash or another of these skin symptoms, stop taking Retacrit and contact your doctor or seek medical attention immediately.
Croatian: Ako razvijete ozbiljan osip ili se u Vas pojavi bilo koji drugi od ovih simptoma na koži, prestanite primjenjivati Retacrit i odmah se obratite liječniku ili potražite medicinsku pomoć.
English: Some patients with more extended dosing intervals (greater than once weekly) of epoetin zeta may not maintain adequate haemoglobin levels (see section 5.1) and may require an increase in epoetin zeta dose.
Croatian: U nekih bolesnika s duljim intervalima doziranja epoetina zeta (duljim od jedanput tjedno) odgovarajuća razina hemoglobina možda se neće održati (vidjeti dio 5.1), što može zahtijevati povećanje doze epoetina zeta.
English: These patients responded to epoetin alfa therapy in a manner similar to that observed in patients on dialysis.
Croatian: Ti su bolesnici odgovorili na terapiju epoetinom alfa na sličan način kao i bolesnici na dijalizi.
English: Following intravenous administration of erythropoietin in subjects with chronic renal failure, the volume of distribution ranged from 57-107 mL/kg after single dosing (12 IU/kg) to 42-64 mL/kg after multiple dosing (48-192 IU/kg), respectively.
Croatian: Nakon intravenske primjene eritropoetina u ispitanika s kroničnim zatajenjem bubrega, volumen distribucije bio je u rasponu od 57 - 107 ml/kg nakon jedne doze (12 IU/kg) do 42 - 64 ml/kg nakon višestrukih doza (48 - 192 IU/kg).
English: If you are given a product in this group other than Retacrit during your treatment, speak to your doctor or pharmacist before using it.
Croatian: Ako ste tijekom liječenja Retacritom dobili lijek iz ove skupine koji nije Retacrit, obratite se liječniku ili ljekarniku prije nego što ga primijenite.
English: Do not shake Retacrit syringes.
Croatian: Nemojte tresti štrcaljke Retacrita.
English: • Your doctor will maintain your haemoglobin level between 10 and 12 g/dL as a high haemoglobin level may increase the risk of blood clots and death.
Croatian: • Liječnik će Vam održavati razinu hemoglobina između 10 i 12 g/dl jer visoka razina hemoglobina može povećati rizik od krvnih ugrušaka i smrti.
English: The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which ESAs are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
Croatian: U ispitivanja su bili uključeni ili bolesnici liječeni kemoterapijom (dva ispitivanja) ili populacije bolesnika u kojih nisu bili indicirani ESA lijekovi: onkoloških bolesnika s anemijom koji ne primaju kemoterapiju i bolesnika s rakom glave i vrata koji primaju terapiju zračenjem.
English: Pharmacokinetic data in neonates is limited.
Croatian: Farmakokinetički podaci u novorođenčadi su ograničeni.
English: Retacrit is presented as a clear and colourless solution for injection in a pre-filled syringe with a fixed injection needle.
Croatian: Retacrit je bistra i bezbojna otopina za injekciju u napunjenoj štrcaljki s pričvršćenom iglom za injekciju.
English: • increased risk of death when administered to achieve a haemoglobin concentration level of 12 g/dL (7.5 mmol/L) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Croatian: • povećan rizik od smrtnog ishoda kada su primjenjivani s ciljem postizanja koncentracije hemoglobina od 12 g/dl (7,5 mmol/l) u bolesnika s aktivnom malignom bolesti koji nisu primali ni kemoterapiju ni terapiju zračenjem.
English: At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Croatian: U trenutku propisivanja lijeka bolesnika treba upoznati s mogućim znakovima i simptomima, a zatim ga pomno pratiti zbog mogućih kožnih reakcija.
English: In 5 small, open label, uncontrolled studies (number of patients ranged from 9-22, total N=72), Epoetin alfa has been administered subcutaneously in children at starting doses of 100 IU/kg/week to 150 IU/kg/week with the possibility to increase up to 300 IU/kg/week.
Croatian: U pet malih, otvorenih, nekontroliranih ispitivanja u djece (broj bolesnika u rasponu od 9 do 22, ukupan N = 72), epoetin alfa primjenjivan je supkutano u početnim dozama od 100 IU/kg tjedno do 150 IU/kg tjedno uz mogućnost povećanja doze do 300 IU/kg tjedno.
English: Recombinant human EPO (epoetin zeta), expressed in Chinese hamster ovary cells, has a 165 amino acid sequence identical to that of human urinary EPO; the 2 are indistinguishable on the basis of functional assays.
Croatian: Rekombinantni ljudski eritropoetin (epoetin zeta) izražen u stanicama jajnika kineskog hrčka, ima slijed od 165 aminokiselina koji je jednak onome u eritropoetinu izoliranom iz ljudskog urina; razliku između ta dva eritropoetina ne može se ustanoviti funkcionalnim testovima.
English: In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Croatian: U otvorenom ispitivanju nije bilo razlike u ukupnom preživljenju između bolesnika liječenih rekombinantnim ljudskim eritropoetinom i kontrolnih ispitanika.
English: Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions, and angioneurotic oedema have been reported (see section 4.4).
Croatian: Zabilježene su reakcije preosjetljivosti, uključujući slučajeve osipa (uključujući urtikariju), anafilaktičke reakcije i angioneurotskog edema (vidjeti dio 4.4).
English: Epoetin zeta is not approved in the management of anaemia associated with hepatitis C.
Croatian: Epoetin zeta nije odobren za liječenje anemije povezane s hepatitisom C.
English: • Grasp the tip of the plastic needle catcher and bend it away from needle cover.
Croatian: • Uhvatite vrh plastičnog "hvatača" igle i savijte ga prema dolje, dalje od pokrov igle.
English: • Retacrit is used to treat symptomatic anaemia caused by kidney disease
Croatian: • Retacrit se koristi za liječenje simptomatske anemije uzrokovane bolešću bubrega:
English: In 2 studies with extended interval dosing of epoetin alfa (3 times per week, once weekly, once every 2 weeks, and once every 4 weeks) some patients with longer dosing intervals did not maintain adequate haemoglobin levels and reached protocol-defined haemoglobin withdrawal criteria (0% in once weekly, 3.7% in once-every-2-weeks, and 3.3% in the once-every-4-weeks groups).
Croatian: U 2 ispitivanja s produljenim intervalom doziranja epoetina alfa (3 puta tjedno, jednom tjedno, jednom u 2 tjedna i jednom u 4 tjedna) u nekih se bolesnika s duljim intervalom doziranja nisu održale odgovarajuće razine hemoglobina i nisu dosegnuti kriteriji definirani planom ispitivanja za izlazak iz ispitivanja na temelju vrijednosti hemoglobina (0% za primjenu jednom tjedno, 3,7% za primjenu jednom u 2 tjedna i 3,3% za primjenu jednom u 4 tjedna).