FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are a patient with hepatitis C and you receive interferon and ribavirin, you should discuss this with your doctor because a combination of epoetin alfa 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: Ako imate hepatitis C i primate interferon i ribavirin, trebate o tome razgovarati s Vašim liječnikom jer je kombinacija epoetina alfa s interferonom i ribavirinom u rijetkim slučajevima dovela do gubitka djelovanja i razvoja stanja pod nazivom izolirana aplazija crvene krvne loze (engl. pure red cell aplasia, PRCA), teškog oblika 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 za održavanje hematokrita između 30 i 36 % bio je otprilike 75 IU/kg 3 puta tjedno.
English: • You may take Epoetin alfa HEXAL out of the refrigerator and keep it at room temperature (up to 25°C) for no longer than 3 days.
Croatian: • Možete izvaditi Epoetin alfa HEXAL iz hladnjaka i čuvati ga na sobnoj temperaturi (do 25 °C)
English: Instructions on how to inject yourself (for patients with symptomatic anaemia caused by kidney disease, for adult patients receiving chemotherapy, adult patients scheduled for orthopaedic surgery, or adult patients with myelodysplastic syndromes only)
Croatian: Upute za samostalnu primjenu injekcije (samo za bolesnike sa simptomatskom anemijom prouzročenom bolešću bubrega, za odrasle bolesnike koji primaju kemoterapiju, odrasle bolesnike u kojih se planira ortopedski kirurški zahvat ili odrasle bolesnike s mijelodisplastičnim sindromima)
English: You may still be able to use Epoetin alfa HEXAL, but discuss it with your doctor first.
Croatian: Možda ćete i dalje moći primati Epoetin alfa HEXAL, ali prvo razgovarajte o tome s Vašim liječnikom.
English: Clinical data with subcutaneous administration in children are limited.
Croatian: Klinički podaci kod supkutane primjene u djece su ograničeni.
English: Treatment with Epoetin alfa HEXAL has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
Croatian: Liječenje Epoetin alfa HEXALom mora se započeti pod nadzorom liječnika s iskustvom u liječenju bolesnika s gore navedenim indikacijama.
English: In these studies, most were predialysis patients (N = 44), 27 patients were on peritoneal dialysis and 2 were on haemodialysis with age ranging from 4 months to 17 years.
Croatian: U tim ispitivanjima, većina je bolesnika bila u fazi prije dijalize (N = 44), 27 bolesnika bilo je na peritonealnoj dijalizi, a 2 su bila na hemodijalizi, a dob im se kretala u rasponu od 4 mjeseci do 17 godina.
English: • You will usually continue Epoetin alfa HEXAL treatment for one month after the end of chemotherapy.
Croatian: • Obično ćete nastaviti s liječenjem Epoetin alfa HEXALom još mjesec dana nakon završetka kemoterapije.
English: The pre-filled syringes are ready to use (see section 4.2).
Croatian: Napunjene štrcaljke su spremne za primjenu (vidjeti dio 4.2).
English: • Always use Epoetin alfa HEXAL exactly as instructed by your doctor or nurse.
Croatian: • Uvijek primijenite Epoetin alfa HEXAL točno onako kako su Vam rekli liječnik ili medicinska sestra.
English: • Flu-like symptoms, such as headache, aches and pains in the joints, feeling of weakness, chills, tiredness and dizziness.
Croatian: • Simptomi nalik gripi, kao što su glavobolja, tupi bolovi i probadanje u zglobovima, osjećaj slabosti, zimica, umor i omaglica.
English: In those situations in which the physician determines that a patient or caregiver can safely and effectively administer Epoetin alfa HEXAL subcutaneously themselves, instruction as to the proper dosage and administration should be provided.
Croatian: U situacijama u kojima liječnik ustanovi da bolesnik ili osoba koja se brine o bolesniku može sigurno i učinkovito primijeniti Epoetin alfa HEXAL supkutano, potrebno je dati upute o ispravnom doziranju i primjeni.
English: - All contraindications associated with autologous blood predonation programmes should be respected in patients being supplemented with Epoetin alfa HEXAL.
Croatian: - Sve kontraindikacije vezane uz programe autologne predonacije krvi moraju se poštovati u bolesnika koji primaju Epoetin alfa HEXAL.
English: • Your doctor will order blood tests, and may adjust the dose, depending on how your anaemia responds to Epoetin alfa HEXAL treatment.
Croatian: • Liječnik će zatražiti krvne pretrage i možda prilagoditi dozu, ovisno o odgovoru Vaše anemije na liječenje Epoetin alfa HEXALom.
English: An inverse relationship between apparent clearance and dose was noted in healthy subjects.
Croatian: Zabilježena je obrnuta povezanost između prividnog klirensa i doze u zdravih ispitanika.
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 Epoetin alfa HEXAL).
Croatian: • ako Vam je dijagnosticirana izolirana aplazija crvene krvne loze (koštana srž ne može proizvesti dovoljno crvenih krvnih stanica) nakon prethodnog liječenja bilo kojim lijekom koji potiče stvaranje crvenih krvnih stanica (uključujući Epoetin alfa HEXAL).
English: For subcutaneous and intravenous use.
Croatian: Za supkutanu primjenu i intravensku primjenu.
English: Epoetin alfa HEXAL should be administered after the completion of the blood donation procedure.
Croatian: Epoetin alfa HEXAL treba primijeniti nakon završetka postupka donacije krvi.
English: • High levels of blood potassium which can cause abnormal heart rhythm (this is a very common side effect in patients on dialysis).
Croatian: • Visoke razine kalija u krvi koje mogu uzrokovati poremećaj srčanog ritma (to je vrlo česta nuspojava u bolesnika na dijalizi)
English: Overall, based on the results of these pharmacodynamic studies in healthy subjects, the 40,000 IU once-weekly dosing regimen seems to be more efficient in producing RBCs than the biweekly regimens despite an observed similarity in reticulocyte production in the once-weekly and biweekly regimens.
Croatian: Sveukupno, na temelju rezultata ovih farmakodinamičkih ispitivanja na zdravim dobrovoljcima čini se da je režim doziranja s 40 000 IU jednom tjedno djelotvorniji u proizvodnji crvenih krvnih stanica nego režimi s primjenom jednom u dva tjedna unatoč uočenoj sličnosti u proizvodnji retikulocita kod ta dva režima.
English: When this access (via a vein or tube) is not readily available, your doctor may decide that Epoetin alfa HEXAL should be injected under the skin (subcutaneously).
Croatian: Kada taj pristup (putem vene ili cjevčice) nije lako dostupan, Vaš liječnik može odlučiti da se Epoetin alfa HEXAL treba ubrizgavati pod kožu (supkutano).
English: If partial use of a syringe is required, remove unwanted solution before injection.
Croatian: Ako je potrebno primijeniti samo dio sadržaja štrcaljke, uklonite neželjeni dio otopine prije davanja injekcije.
English: Do not freeze or shake.
Croatian: Ne zamrzavati ili tresti.
English: Adverse drug reactions reported by ≥ 1% of subjects treated with epoetin alfa in these trials are shown in the table below.
Croatian: Nuspojave koje je prijavilo ≥ 1 % ispitanika liječenih epoetinom alfa u tim ispitivanjima navedene su u tablici ispod.
English: Dose increase: Dose should not be increased over the maximum of 1050 IU/kg (total dose 80,000 IU)
Croatian: Povećanje doze: doza se ne smije povećavati iznad maksimalne doze od 1050 IU/kg (ukupna doza 80 000 IU) tjedno.
English: • If you do not respond adequately to Epoetin alfa HEXAL, your doctor will check your dose and will inform you if you need to change doses of Epoetin alfa HEXAL.
Croatian: • Ako ne budete odgovarali na liječenje Epoetin alfa HEXALom na odgovarajući način, Vaš će liječnik provjeriti Vašu dozu i obavijestiti Vas ako trebate promijeniti doze Epoetin alfa HEXALa.
English: For the purpose of ambulatory use, the medicinal product may be taken out of the refrigerator, without being replaced, for a maximum period of 3 days at a temperature not above 25°C.
Croatian: U svrhu izvanbolničke primjene, lijek se može izvaditi iz hladnjaka i čuvati se na temperaturi ne višoj od 25 °C, bez vraćanja u hladnjak, tijekom najviše 3 dana.
English: • Once your anaemia has been corrected, your doctor will continue to check your blood regularly.
Croatian: • Nakon što se anemija ispravi, liječnik će nastaviti s redovitim krvnim pretragama.
English: - The active substance is: epoetin alfa (for quantity see the table below).
Croatian: - Djelatna tvar je: epoetin alfa (količinu vidjeti u tablici niže).
English: You may have chest pain, breathlessness, and painful swelling and redness, usually in the leg as symptoms.
Croatian: Možete imati bol u prsištu, nedostatak zraka i bolni otok i crvenilo, obično na nozi, kao simptome.
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 uzrokuje mutaciju bakterijskih gena (Amesov test), aberacije kromosoma u stanicama sisavaca, mikronukleusa u miševa niti mutaciju gena na HGPRT lokusu.
English: This section contains information on how to give yourself an injection of Epoetin alfa HEXAL.
Croatian: Ovaj dio sadrži informacije o tome kako da sami sebi date injekciju Epoetin alfa HEXAL.
English: Epoetin alfa therapy should continue until one month after the end of chemotherapy.
Croatian: Terapiju epoetinom alfa treba nastaviti do mjesec dana nakon završetka kemoterapije.
English: Epoetin alfa HEXAL is given alone and not mixed with other liquids for injection.
Croatian: Epoetin alfa HEXAL se daje sam i ne smije se miješati s drugim tekućinama za injekciju.
English: The needle safety guard will rapidly move to cover the needle.
Croatian: Zaštitni mehanizam za iglu će se brzo pokrenuti i prekriti iglu.
English: Talk to your doctor, pharmacist or nurse before using Epoetin alfa HEXAL.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Epoetin alfa HEXAL.
English: The greatest effects are observed in patients with low haemoglobin (≤ 13 g/dL).
Croatian: Najveći učinci uočeni su u bolesnika s niskim hemoglobinom (≤ 13 g/dl).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL/SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA/ŠTRCALJKA
English: - Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive Epoetin alfa HEXAL or any other erythropoietin (see section 4.4).
Croatian: - Bolesnici koji razviju izoliranu aplaziju crvene loze (engl. pure red cell aplasia, PRCA) nakon liječenja bilo kojim eritropoetinom ne smiju primiti Epoetin alfa HEXAL ili bilo koji drugi eritropoetin (vidjeti dio 4.4).
English: It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Croatian: Važno je da ne pokušavate sami sebi dati injekciju ako Vas o tome nisu posebno podučili Vaš liječnik ili medicinska sestra.
English: If the patient loses response or haemoglobin concentration drops by ≥ 1 g/dL upon dose reduction the dose should be increased by one dosing step.
Croatian: Ako se u bolesnika izgubi odgovor ili koncentracija hemoglobina padne za ≥ 1 g/dl nakon smanjenja doze, dozu treba povećati za jedan korak u doziranju.
English: Some patients with more extended dosing intervals (greater than once weekly) of epoetin alfa may not maintain adequate haemoglobin levels (see section 5.1) and may require an increase in epoetin alfa dose.
Croatian: Neki bolesnici s dužim intervalima doziranja (duljim od jedanput tjedno) epoetina alfa možda neće moći održati odgovarajuće razine hemoglobina (vidjeti dio 5.1) i mogu zahtijevati povišenje doze epoetina alfa.
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 pažljivo pratiti razinu hemoglobina zbog potencijalno povećanog rizika od tromboembolijskih događaja i smrtnih ishoda kada liječeni bolesnici imaju razinu hemoglobina iznad raspona koncentracije u indikaciji za primjenu lijeka.
English: • Epoetin alfa HEXAL is given by injection under the skin each week for three weeks before surgery and on the day of surgery.
Croatian: • Epoetin alfa HEXAL se daje injekcijom pod kožu svaki tjedan tijekom tri tjedna prije kirurškog zahvata i na sam dan kirurškog zahvata.
English: Chronic renal failure patients treated with epoetin alfa by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to epoetin alfa treatment in patients who previously responded to such therapy.
Croatian: Bolesnici s kroničnim zatajenjem bubrega liječeni epoetinom alfa supkutanim putem trebaju se redovito pratiti radi gubitka djelotvornosti, definiranim kao odsustvo ili smanjenje odgovora na liječenje epoetinom alfa u bolesnika koji su prethodno odgovarali na takvu terapiju.
English: In controlled clinical studies, use of epoetin alfa and other ESAs have been associated with decreased locoregional tumour control or decreased overall survival:
Croatian: U kontroliranim kliničkim ispitivanjima, primjena epoetina alfa i drugih lijekova za stimulaciju eritropoeze bila je povezana sa smanjenom lokoregionalnom kontrolom tumora ili smanjenim ukupnim preživljenjem:
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 Epoetin alfa HEXAL.
Croatian: Ako uzimate lijek koji se zove ciklosporin (uzima se npr., nakon presađivanja bubrega), liječnik će raditi krvne pretrage kako bi provjerio razinu ciklosporina dok primate Epoetin alfa HEXAL.
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 broja krvnih pločica (koje se još zovu trombociti), koje normalno sudjeluju u stvaranju krvnih ugrušaka, osobito na početku liječenja.
English: Angioneurotic oedema3
Croatian: manje često angioneurotski edem3
English: On average, patients treated with epoetin alfa were able to predeposit significantly more units of blood (4.5 units) than placebo-treated patients (3.0 units).
Croatian: Bolesnici liječeni epoetinom alfa mogli su, prosječno, prethodno pohraniti značajno više jedinica krvi (4,5 jedinice) nego bolesnici liječeni placebom (3,0 jedinice).
English: The injections should be given in the limbs or the anterior abdominal wall.
Croatian: Injekcije se trebaju dati u područje udova ili prednje trbušne stijenke.
English: These patients responded to epoetin alfa therapy in a manner similar to that observed in patients on dialysis.
Croatian: Ovi su bolesnici odgovorili na terapiju epoetinom alfa na sličan način kao i bolesnici na dijalizi.
English: The recommended total weekly dose is between 75 IU/kg and 300 IU/kg.
Croatian: Preporučena ukupna tjedna doza je između 75 IU/kg i 300 IU/kg
English: Since cyclosporin is bound by red blood cells (RBCs) there is potential for a medicinal product interaction.
Croatian: Budući da se ciklosporin veže na crvene krvne stanice, postoji mogućnost interakcije lijekova.
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin alfa and perform anti-erythropoietin antibody testing.
Croatian: Kod paradoksalnog sniženja hemoglobina i razvoja teške anemije povezane s niskim brojem retikulocita treba odmah prekinuti liječenje epoetinom alfa i provesti testiranje na antieritropoetinska protutijela.
English: In haemodialysed patients, a bolus injection may be given during the dialysis session through a suitable venous port in the dialysis line.
Croatian: Bolesnicima na hemodijalizi može se dati bolus injekcija tijekom samog postupka dijalize putem odgovarajućeg venskog porta na liniji za dijalizu.
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 dosljedan i neobjašnjiv, statistički značajno veći mortalitet u bolesnika koji su imali anemiju povezanu s različitim čestim rakom i primali rekombinantni humani eritropoetin nego u kontrolnih bolesnika.
English: 25.2 micrograms 33.6 micrograms 42.0 micrograms 50.4 micrograms 58.8 micrograms 67.2 micrograms 75.6 micrograms 84.0 micrograms
Croatian: 25,2 mikrograma 33,6 mikrograma 42,0 mikrograma 50,4 mikrograma 58,8 mikrograma 67,2 mikrograma 75,6 mikrograma 84,0 mikrograma
English: A randomised, open-label, multicentre study was conducted in 2,098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy.
Croatian: Randomizirano, otvoreno, multicentrično ispitivanje provedeno je u 2098 anemičnih bolesnica s metastatskim rakom dojke, koje su primale prvu liniju ili drugu liniju kemoterapije.
English: Based on information available to date, correction of anaemia with epoetin alfa in adult patients with renal insufficiency not yet undergoing dialysis does not accelerate the rate of progression of renal insufficiency.
Croatian: Na osnovi do sada dostupnih podataka, korekcija anemije epoetinom alfa u odraslih bolesnika s insuficijencijom bubrega koji još nisu podvrgnuti dijalizi ne ubrzava napredovanje insuficijencije bubrega.
English: In clinical trials conducted in patients with CRF not on dialysis treated with epoetin alfa, the average duration of therapy was nearly five months.
Croatian: U kliničkim ispitivanjima provedenima u bolesnika s KZB koji nisu na dijalizi i koji su liječeni epoetinom alfa, prosječno trajanje terapije bilo je skoro pet mjeseci.
English: Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal (see section 4.8).
Croatian: Osobitu pažnju treba posvetiti iznenadnim probadajućim glavoboljama nalik migreni kao mogućem znaku upozorenja (vidjeti dio 4.8).
English: Erythroid response during the first 24 weeks of the study was demonstrated by 27/85 (31.8%) of the subjects in the epoetin alfa group compared to 2/45 (4.4%) of the subjects in the placebo group (p < 0.001).
Croatian: Eritroidni odgovor tijekom prva 24 tjedna ispitivanja demonstriran je u 27/85 (31,8 %) ispitanika u skupini liječenoj epoetinom alfa u usporedbi s 2/45 (4,4 %) ispitanika u skupini koja je primala placebo (p < 0,001).
English: Particular attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal (see section 4.4).
Croatian: Osobitu pažnju treba posvetiti iznenadnim probadajućim glavoboljama nalik migreni kao mogućem znaku upozorenja (vidjeti dio 4.4).
English: After injecting the liquid, remove the needle and let go of your skin.
Croatian: Nakon ubrizgavanja tekućine, izvadite iglu i pustite nabor kože.
English: Subjects were stratified by serum erythropoetin (sEPO) level and prior transfusion status at screening.
Croatian: Ispitanici su stratificirani ovisno o razini serumskog eritropoetina (sEPO) i prethodnom transfuzijskom statusu pri probiru.
English: The maximum dosage should not exceed 150 IU/kg, 3 times per week, 240 IU/kg (up to a maximum of 20,000 IU) once weekly, or 480 IU/kg (up to a maximum of 40,000 IU) once every 2 weeks.
Croatian: Maksimalna doza ne smije biti veća od 150 IU/kg 3 puta tjedno, 240 IU/kg (najviše do 20 000 IU) jednom tjedno, ili 480 IU/kg (najviše do 40 000 IU) jednom svaka 2 tjedna.
English: No evidence exists that indicates an interaction between epoetin alfa and granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Croatian: Ne postoje dokazi koji ukazuju na interakciju između epoetina alfa i čimbenika stimulacije granulocitnih kolonija (G-CSF) ili čimbenika stimulacije granulocitnih i makrofagnih kolonija (GM-CSF) s obzirom na hematološku diferencijaciju ili proliferaciju uzoraka biopsije tumora in vitro.
English: No paediatric-specific adverse reactions not mentioned previously in the table above, or any that were not consistent with the underlying disease were reported in this population.
Croatian: Nisu zabilježene nuspojave specifične za pedijatrijsku populaciju koje nisu navedene u tablici iznad ili koje nisu u skladu s osnovnom bolešću.
English: • Epoetin alfa HEXAL is given by injection under the skin.
Croatian: • Epoetin alfa HEXAL se daje injekcijom pod kožu.
English: No a one subject did not have sEPO data b in the ≥ 200 mU/mL stratum there were 13 subjects in the epoetin alfa group and 6 subjects in the placebo group
Croatian: Ne a jedan ispitanik nije imao sEPO podatke b u stratumu ≥ 200 mU/ml bilo je 13 ispitanika u skupini liječenoj epoetinom alfa i 6 ispitanika u skupini koja je primala placebo
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 5 malih, otvorenih, nekontroliranih ispitivanja (broj bolesnika u rasponu od 9-22, ukupan N = 72), epoetin alfa se u djece primjenjivao supkutano u početnim dozama od 100 IU/kg/tjedno do 150 IU/kg/tjedno uz mogućnost povećanja do
English: If you visit a hospital, clinic or family doctor, tell them you are having Epoetin alfa HEXAL treatment.
Croatian: Ako morate ići u bolnicu, na kliniku ili obiteljskom liječniku, recite im da se liječite Epoetin alfa HEXALom.
English: • Blood clots may also form in your haemodialysis system.
Croatian: • Krvni ugrušci se mogu pojaviti i u samom sustavu za hemodijalizu.
English: While maintaining pressure on the plunger, remove the syringe from the patient.
Croatian: Zadržavajući pritisak na klipu, izvucite iglu iz bolesnika.
English: The recommended starting dose is Epoetin alfa HEXAL 450 IU/kg (maximum total dose is 40,000 IU) administered subcutaneously once every week, with not less than 5 days between doses.
Croatian: Preporučena početna doza je Epoetin alfa HEXAL 450 IU/kg (maksimalna ukupna doza je 40 000 IU) primijenjena supkutano jednom svakog tjedna, s ne manje od 5 dana između doza.
English: Form a skin fold by pinching the skin between thumb and forefinger.
Croatian: Uhvatite nabor kože između palca i kažiprsta.
English: When treatment starts, Epoetin alfa HEXAL is usually injected by a medical professional or a nurse.
Croatian: Na početku liječenja Epoetin alfa HEXAL će Vam obično injicirati liječnik ili medicinska sestra.
English: If you are a cancer patient, be aware that use of Epoetin alfa HEXAL 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 ste bolesnik koji ima rak, morate znati da primjena Epoetin alfa HEXALa može biti povezana s kraćim preživljenjem i višom stopom smrti u bolesnika s rakom glave i vrata i metastatskim rakom dojke koji primaju kemoterapiju.