FrancophonIA/ELRC3.0 huggingface dataset:
English: In clinical trials, an increased risk of death and serious cardiovascular events was observed when ESAs were administered to achieve a haemoglobin concentration level of greater than 12 g/dL (7.5 mmol/L).
Croatian: U kliničkim ispitivanjima je opažen povećani rizik od smrti i ozbiljnih kardiovaskularnih događaja kada su primjenjivani lijekovi za stimulaciju eritropoeze za postizanje vrijednosti koncentracije hemoglobina veće od 12 g/dl (7,5 mmol/l).
English: A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/L) over a four week period should be avoided.
Croatian: Porast hemoglobina za više od 2 g/dl (1,25 mmol/l) tijekom razdoblja od četiri tjedna treba izbjegavati.
English: Despite differences in concentration-time profiles the pharmacodynamic response (as measured by changes in percent reticulocytes, haemoglobin, and total RBCs) was similar between these regimens.
Croatian: farmakodinamički odgovor (mjeren promjenama postotka retikulocita, hemoglobina i ukupnih crvenih krvnih stanica) na ta dva režima bio je sličan.
English: Because Epoetin alfa HEXAL stimulates the production of red blood cells, doctors can take more blood from these people.
Croatian: Epoetin alfa HEXAL potiče stvaranje crvenih krvnih stanica, liječnici mogu uzeti veću količinu krvi od tih bolesnika.
English: PRCA causes sudden and severe anaemia.
Croatian: Izolirana aplazija crvene loze uzrokuje iznenadnu i tešku anemiju.
English: Recombinant human EPO (epoetin alfa), 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 humani EPO (epoetin alfa eksprimiran u stanicama ovarija kineskog hrčka, ima slijed od 165 aminokiselina identičan onome u EPO-u izoliranom iz ljudskog urina; nije ih moguće razlikovati na temelju testova funkcije.Prividna molekularna masa eritropoetina je 32 000 do 40 000 daltona.
English: • can't take medicines to thin the blood
Croatian: Ako ne smijete uzimati lijekove za sprječavanje zgrušavanja krvi,
English: • Blood clots (thrombosis) may form in your dialysis shunt.
Croatian: • Krvni ugrušci (tromboza) mogu se pojaviti u spoju za dijalizu.
English: Significantly fewer patients received RBC transfusions in the epoetin alfa plus SOC arm (5.8% versus 11.4%); however, significantly more patients had thrombotic vascular events in the epoetin alfa plus SOC arm (2.8% versus 1.4%).
Croatian: U skupini liječenoj epoetinom alfa plus standardna terapija značajno manji broj bolesnica primio je transfuzije crvenih krvnih stanica (5,8 % naspram 11,4 %); međutim, u istoj skupini značajno veći broj bolesnica imao je trombotske vaskularne događaje (2,8 % naspram 1,4 %).
English: Epoetin alfa HEXAL should not be used:
Croatian: Epoetin alfa HEXAL ne smijete koristiti:
English: Congenital, familial and genetic disorders
Croatian: Prirođeni, obiteljski i genetski poremećaji akutna porfirija3
English: The exposure of paediatric patients with chronic renal failure on haemodialysis in clinical trials and post-marketing experience is limited.
Croatian: Pedijatrijska populacija s kroničnim zatajenjem bubrega na hemodijalizi Izloženost pedijatrijskih bolesnika s kroničnim zatajenjem bubrega hemodijalizi u kliničkim ispitivanjima i nakon stavljanja lijeka u promet je ograničeno.
English: Randomised
Croatian: Randomizirani
English: Epoetin alfa HEXAL contains less than 1 mmol sodium (23 mg) per dose that is to say essentially “sodium free”.
Croatian: Epoetin alfa HEXAL sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Caution should be exercised with escalation of Epoetin alfa HEXAL doses in patients with chronic renal failure.
Croatian: Potreban je oprez pri povećavanju doza Epoetin alfa HEXALa u bolesnika s kroničnim zatajenjem bubrega.
English: Later, your doctor may suggest that you or your caregiver learn how to inject Epoetin alfa HEXAL under the skin (subcutaneously) yourself.
Croatian: Kasnije Vaš liječnik može predložiti da Vi ili Vaš njegovatelj naučite kako sami davati Epoetin alfa
English: • have recently had a heart attack or stroke
Croatian: • imate teške poremećaje vena i arterija • nedavno ste imali srčani ili moždani udar
English: If you forget to use Epoetin alfa HEXAL
Croatian: Ako ste zaboravili primijeniti Epoetin alfa HEXAL
English: In the single-blind study, patients were treated with epoetin alfa 300 IU/kg or 600 IU/kg or placebo intravenously once daily every 3 to 4 days over 3 weeks (total 6 doses).
Croatian: U jednostruko slijepom ispitivanju, bolesnici su liječeni s 300 IU/kg ili 600 IU/kg epoetina alfa ili placebom intravenski jednom dnevno svaka 3 do 4 dana tijekom 3 tjedna (ukupno 6 doza).
English: More cases have been reported with subcutaneous (SC) route of administration, compared with the IV route.
Croatian: Više slučajeva prijavljeno je uz supkutani put primjene nego uz intravenski put.
English: In the 16-week study (n = 222), in the epoetin alfa-treated patients there was no statistically significant effect on patient-reported or parent-reported Paediatric Quality of Life Inventory or Cancer Module scores compared with placebo (primary efficacy endpoint).
Croatian: U 16-tjednom ispitivanju (N = 222) u bolesnika liječenih epoetinom alfa nije bilo statistički značajnog učinka na rezultate upitnika za procjenu kvalitete života pedijatrijskih bolesnika (engl.
English: • Epoetin alfa HEXAL is given by injection into a vein immediately after you have donated blood for 3 weeks before your surgery.
Croatian: • Epoetin alfa HEXAL se daje injekcijom u venu, odmah nakon što ste donirali krv tijekom
English: In patients scheduled for major elective orthopaedic surgery with a pretreatment haemoglobin of > 10 to ≤ 13 g/dL, epoetin alfa has been shown to decrease the risk of receiving allogeneic transfusions and hasten erythroid recovery (increased haemoglobin levels, haematocrit levels, and reticulocyte counts).
Croatian: Dokazano je da epoetin alfa u bolesnika predviđenih za veliki elektivni ortopedski kirurški zahvat s razinom hemoglobina od > 10 do ≤ 13 g/dl prije liječenja smanjuje rizik od primanja alogenih transfuzija i ubrzava eritroidni oporavak (povišene razine hemoglobina i hematokrita te broja retikulocita).
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: 2833 bolesnika, od kojih su četiri bila dvostruko slijepa, placebom kontrolirana ispitivanja, a jedno je bilo otvoreno ispitivanje.
English: If necessary, increase or decrease the dose by 25 IU/kg (3 times per week) until the desired haemoglobin concentration range between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L) is achieved (this should be done in steps of at least four weeks).
Croatian: Ako je potrebno, doza se može povećati ili smanjiti za 25 IU/kg (3 puta tjedno) dok se ne postigne željeni raspon koncentracije hemoglobina između 10 g/dl i 12 g/dl (6,2 i 7,5 mmol/l) (to treba učiniti u razmacima od najmanje četiri tjedna).
English: A less defined profile was observed for RBCs and haemoglobin.
Croatian: Slabije definiran profil krivulje uočen je za crvene krvne stanice i hemoglobin.
English: - The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
Croatian: Drugi sastojci su: natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, glicin, polisorbat 80, kloridna kiselina (za podešavanje pH), natrijev hidroksid (za podešavanje pH) i voda za injekcije.
English: - If the haemoglobin concentration has increased < 1 g/dL (< 0.62 mmol/L) and the reticulocyte count has increased < 40,000 cells/µL above baseline, response is unlikely and treatment should be discontinued.
Croatian: - Ako se koncentracija hemoglobina povećala za < 1 g/dl (< 0,62 mmol/l) i broj retikulocita se povećao za < 40 000 stanica/µl iznad početne vrijednosti, najvjerojatnije neće biti odgovora i liječenje treba prekinuti.
English: The mean CL/F for the 150 IU/kg 3 times-per-week and 40,000 IU once-weekly regimens in healthy subjects were 31.2 and 12.6 mL/h/kg, respectively.
Croatian: Srednja vrijednost oralnog klirensa (CL/F) u zdravih ispitanika za režim doziranja od 150 IU/kg 3 puta tjedno bila je 31,2 ml/h/kg, a za 40 000 IU jednom tjedno 12,6 ml/h/kg.
English: Headaches, particularly sudden, stabbing migraine-like headaches, feeling confused or having fits may be signs of a sudden increase in blood pressure.
Croatian: osjećaj smetenosti ili napadaji mogu biti znakovi naglog povišenja krvnog tlaka.
English: Your Epoetin alfa HEXAL dose and frequency of administration may be further adjusted to maintain your response to treatment.
Croatian: Dodatno Vam može prilagoditi dozu i učestalost primjene Epoetin alfa HEXALa kako bi se održao odgovor na liječenje.
English: • The recommended dose is 600 IU per kilogram body weight once a week.
Croatian: • Preporučena doza je 600 IU po kilogramu tjelesne težine jednom tjedno.
English: All other causes of anaemia (iron, folate or vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin) should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.
Croatian: Potrebno je razmotriti sve druge uzroke anemije (nedostatak željeza, folata ili vitamina B12, trovanje aluminijem, infekcija ili upala, gubitak krvi, hemoliza i fibroza koštane srži bilo kojeg porijekla)
English: Epoetin alfa was evaluated in an open-label, non-randomised, open dose-range, 52-week clinical study in paediatric CRF patients undergoing haemodialysis.
Croatian: Kronično zatajenje bubrega Epoetin alfa ocijenjen je u otvorenom, nerandomiziranom kliničkom ispitivanju otvorenog raspona doza koje je trajalo 52 tjedna u pedijatrijskih bolesnika s KZB na hemodijalizi.
English: Cancer patients being treated with epoetin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Croatian: Onkološkim bolesnicima koji se liječe epoetinom alfa potrebno je redovito mjeriti razinu hemoglobina sve dok ne postignu stabilnu razinu, te povremeno nakon toga.
English: Epoetin alfa HEXAL is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of ≤ 10 g/dL) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/mL).
Croatian: ≤ 10 g/dl) u odraslih s primarnim mijelodisplastičnim sindromom (MDS) niskog ili srednjeg-1 rizika koji imaju niski serumski eritropoetin (< 200 mU/ml).
English: - For patients in an autologous predonation programme, iron supplementation (elemental iron 200 mg/day orally) should be administered several weeks prior to initiating the autologous predeposit in order to achieve high iron stores prior to starting epoetin alfa therapy, and throughout the course of epoetin alfa therapy.
Croatian: 200 mg/dan peroralno) treba se primijeniti nekoliko tjedana prije početka autologne pohrane kako bi se postigle velike zalihe željeza prije početka i tijekom terapije epoetinom alfa.
English: Patients treated with epoetin alfa were also able to predeposit significantly more units of blood (epoetin alfa 300 IU/kg = 4.4 units; epoetin alfa 600 IU/kg = 4.7 units) than placebo-treated patients (2.9 units).
Croatian: 300 IU/kg = 4,4 jedinice; epoetin alfa 600 IU/kg = 4,7 jedinica) nego bolesnici liječeni placebom (2,9 jedinica).
English: • if there has been a refrigerator failure.
Croatian: • ako je hladnjak u kojem se čuvao lijek bio u kvaru.
English: Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
Croatian: Pomoćne tvari: natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, glicin, polisorbat 80, kloridna kiselina (za podešavanje pH), natrijev hidroksid (za podešavanje pH) i voda za injekcije.
English: erythropoietin suggested that distribution volume was approximately 1.5 to 2 times higher in the preterm neonates than in the healthy adults, and clearance was approximately 3 times higher in the preterm neonates than in healthy adults.
Croatian: Ispitivanje u 7 prijevremeno rođene novorođenčadi s vrlo niskom porođajnom težinom i 10 zdravih odraslih koji su primili i.v. eritropoetin pokazalo je da je volumen distribucije bio približno 1,5 do 2 puta veći u prijevremeno rođene novorođenčadi nego u zdravih odraslih, a klirens je bio približno
English: Chronic renal failure patients being treated with epoetin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Croatian: Bolesnicima s kroničnim zatajenjem bubrega koji se liječe epoetinom alfa potrebno je redovito mjeriti razinu hemoglobina sve dok se ne postigne stabilna razina, te povremeno nakon toga.
English: Additional studies compared the 40,000 IU once-weekly regimen of epoetin alfa with biweekly doses ranging from 80,000 to 120,000 IU subcutaneously.
Croatian: 40 000 IU epoetina alfa jednom tjedno i doze u rasponu od 80 000 do 120 000 IU primjenjene supkutano jednom u dva tjedna.
English: Epoetin alfa HEXAL should be administered to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dL (6.2 mmol/L)).
Croatian: Epoetin alfa HEXAL treba primijeniti u bolesnika s anemijom (npr. koncentracija hemoglobina ≤ 10 g/dl (6,2 mmol/l)).
English: An increase in heparin dose during haemodialysis is frequently required during the course of therapy with epoetin alfa as a result of the increased packed cell volume.
Croatian: Zbog povišenja hematokrita za vrijeme terapije epoetinom alfa često je potrebno povisiti dozu heparina tijekom hemodijalize.
English: Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).
Croatian: Neophodno je praćenje krvnog tlaka, osobito na početku terapije
English: Epoetin alfa HEXAL should be administered in order to increase haemoglobin to not greater than 11 g/dL (6.8 mmol/L).
Croatian: Epoetin alfa HEXAL treba primjenjivati kako bi se razina hemoglobina povisila do najviše 11 g/dl (6,8 mmol/l).
English: In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name and the batch number of the administered ESA should be clearly recorded (or stated) in the patient file.
Croatian: Radi poboljšanja sljedivosti lijekova za stimulaciju eritropoeze, u medicinskoj dokumentaciji bolesnika treba pažljivo zabilježiti (ili navesti) zaštićeni naziv i broj serije primijenjenog lijeka za stimulaciju eritropoeze.
English: • the seal is broken.
Croatian: • je pakiranje oštećeno.
English: Anti-erythropoietin antibody positive
Croatian: Pretrage pozitivna anti-eritropoetinska protutijela rijetko
English: “Instructions on how to inject Epoetin alfa HEXAL yourself” can be found at the end of the package leaflet.
Croatian: „Upute za samostalnu primjenu injekcije Epoetin alfa HEXAL” mogu se pronaći na kraju upute o lijeku.
English: Epoetin alfa HEXAL should be administered in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L).
Croatian: Epoetin alfa HEXAL treba primjenjivati kako bi se hemoglobin povisio na razinu koja nije viša od 12 g/dl (7,5 mmol/l).
English: In addition, there was no statistical difference between the proportion of patients requiring pRBC transfusions between the Epoetin alfa group and placebo.
Croatian: Uz to, nije bilo statističke razlike između skupine liječene epoetinom alfa i placebom u udjelu bolesnika kojima su bile potrebne transfuzije crvenih krvnih stanica.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip često urtikarija3
English: Treatment of patients with chemotherapy-induced anaemia
Croatian: Liječenje bolesnika s anemijom induciranom kemoterapijom
English: Antibody-mediated PRCA has been reported after months to years of epoetin alfa treatment.
Croatian: Izolirana aplazija crvene loze posredovana protutijelima prijavljena je nakon više mjeseci ili godina liječenja epoetinom alfa.
English: Pre-filled syringe without needle safety guard
Croatian: Primjena napunjene štrcaljke bez sigurnosnog štitinika za iglu
English: In paediatric patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Epoetin alfa HEXAL by the intravenous route is preferable.
Croatian: U pedijatrijskih bolesnika s kroničnim zatajenjem bubrega u kojih je rutinski dostupan intravenski pristup (bolesnici na hemodijalizi) preferira se primjena lijeka Epoetin alfa HEXAL intravenskim putem.
English: Chemotherapy-induced anaemia
Croatian: Anemija inducirana kemoterapijom
English: From pretreatment to presurgery, the mean increase in haemoglobin in the 600 IU/kg weekly group (1.44 g/dL) was twice than that observed in the 300 IU/kg daily group (0.73 g/dL).
Croatian: Srednja vrijednost porasta razine hemoglobina od razine prije liječenja do razine prije operacije bila je dvostruko veća u skupini koja je primala 600 IU/kg epoetina alfa tjedno (1,44 g/dl) nego u skupini koja je primala 300 IU/kg epoetina alfa dnevno (0,73 g/dl).
English: In patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Epoetin alfa HEXAL by the intravenous route is preferable.
Croatian: U bolesnika s kroničnim zatajenjem bubrega u kojih je rutinski dostupan intravenski pristup (bolesnici na hemodijalizi) preferira se primjena lijeka Epoetin alfa HEXAL intravenskim putem.
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 primarnom ishodu djelotvornosti, tj. udjelu bolesnika kojima je bila potrebna transfuzij crvenih krvnih stanica nakon
English: The median time to progression (TTP) based on investigator-determined progressive disease (PD) was 7.5 months in the epoetin alfa plus SOC group and 7.5 months in the SOC group (HR 1.099, 95% CI: 0.998, 1.210).
Croatian: Medijan vremena do progresije temeljen na ispitivačevoj ocjeni progresivne bolesti bio je 7,5 mjeseci u skupini liječenoj epoetinom alfa plus standardna terapija i 7,5 mjeseci u skupini liječenoj standardnom terapijom (HR 1,099, 95 % CI:
English: Do not shake Epoetin alfa HEXAL syringes.
Croatian: Nemojte tresti štrcaljke Epoetin alfa HEXAL.
English: Chills, Influenza like illness, Injection site reaction, Oedema peripheral
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija vrlo često zimica, bolest nalik gripi, reakcija na mjestu injekcije, periferni edemi često nedjelotvornost lijeka3
English: The safety of epoetin alfa has not been established in patients with hepatic dysfunction.
Croatian: Sigurnost epoetina alfa u bolesnika s poremećajem funkcije jetre nije ustanovljena.
English: • Store and transport refrigerated (2°C-8°C).
Croatian: • Čuvati i prevoziti na hladnom (2 °C - 8 °C).
English: This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, that is to say essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po napunjenoj štrcaljki, tj. zanemarive količine natrija.
English: • The starting dose is 450 IU per kilogram bodyweight once a week.
Croatian: • Početna doza je 450 IU po kilogramu tjelesne težine jednom tjedno.
English: The starting dose is 50 IU/kg, 3 times per week.
Croatian: Početna doza je 50 IU/kg, 3 puta tjedno
English: The product is for single use only.
Croatian: Lijek je namijenjen za jednokratnu primjenu.
English: Store and transport refrigerated (2°C-8°C).
Croatian: Čuvati i prevoziti na hladnom (2 °C-8 °C).
English: In the randomised, double-blind, placebo-controlled, multicentre study 4 (4.7%) subjects experienced TVEs (sudden death, ischaemic stroke, embolism, and phlebitis).
Croatian: (4,7 %) kod ispitanika je došlo do TVD-a (iznenadna smrt, ishemijski moždani udar, embolija i flebitis).
English: The safety and efficacy of epoetin alfa in chronic renal failure patients with anaemia before initiation of dialysis or on peritoneal dialysis have not been established.
Croatian: Anemija u bolesnika s kroničnim zatajenjem bubrega prije započinjanja dijalize ili na peritonealnoj dijalizi Sigurnost i djelotvornost epoetina alfa u bolesnika s kroničnim zatajenjem bubrega i anemijom prije započinjanja dijalize ili na peritonealnoj dijalizi nisu ustanovljene.
English: If the haemoglobin concentration is increasing by more than 2 g/dL (1.25 mmol/L) per month, or if the haemoglobin concentration level exceeds 12 g/dL (7.5 mmol/L), reduce the Epoetin alfa HEXAL dose by about 25 to 50%.
Croatian: Ako se koncentracija hemoglobina povećava za više od 2 g/dl (1,25 mmol/l) na mjesec, ili koncentracija hemoglobina prijeđe 12 g/dl (7,5 mmol/l), smanjite dozu Epoetin alfa HEXALa za oko 25 do 50 %.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Appropriate adjustment of the dose should be made in order to maintain haemoglobin levels within the desired concentration range between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L).
Croatian: Potrebno je učiniti odgovarajuću prilagodbu doze radi održavanja vrijednosti hemoglobina unutar željenog raspona koncentracije između 9,5 g/dl i 11 g/dl (5,9 i 6,8 mmol/l).
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava preosjetljivost3
English: Do not use Epoetin alfa HEXAL:
Croatian: Nemojte primjenjivati Epoetin alfa HEXAL:
English: A haemoglobin concentration of greater than 12 g/dL (7.5 mmol/L) should be avoided.
Croatian: Koncentracija hemoglobina veća od 12 g/dl (7,5 mmol/l) treba se izbjegavati.
English: Starting dose of 50 IU/kg, 3 times per week, followed if necessary by a dosage increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
Croatian: 25 IU/kg (3 puta tjedno) do postizanja željenog cilja (to treba učiniti u razmacima od najmanje četiri tjedna).
English: An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.8).
Croatian: Opažena je povećana incidencija trombotskih vaskularnih događaja (TVD) u bolesnika koji primaju lijekove za stimulaciju eritropoeze (vidjeti dio 4.8).
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Epoetin alfa HEXAL, treatment with Epoetin alfa HEXAL must not be restarted in this patient at any time.
Croatian: U slučaju da se zbog primjene Epoetin alfa HEXALa u bolesnika pojave teške kožne reakcije kao što su Stevens-Johnsonov sindrom ili toksična epidermalna nekroliza, ni u jednom trenutku ne smije se ponovno započeti liječenje tog bolesnika lijekom Epoetin alfa HEXAL.
English: A sustained haemoglobin level of greater than 12 g/dL (7.5 mmol/L) should be avoided.
Croatian: Održavanje razine hemoglobina iznad 12 g/dl (7,5 mmol/l) treba izbjegavati.
English: Epoetin alfa HEXAL contains sodium
Croatian: Epoetin alfa HEXAL sadrži natrij
English: Treatment of paediatric patients scheduled for major elective orthopaedic surgery
Croatian: Liječenje pedijatrijskih bolesnika predviđenih za veliki elektivni ortopedski kirurški zahvat
English: Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions, and angioneurotic oedema have been reported (see section 4.4).
Croatian: anafilaktičke reakcije i angioneurotskog edema (vidjeti dio 4.4).