FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be monitored closely, if the haemoglobin exceeds 12 g/dL (7.5 mmol/L), the dose should be reduced by approximately 25 to 50%.
Croatian: Bolesnike treba pažljivo pratiti te ako hemoglobin prijeđe 12 g/dl (7,5 mmol/l), doza se mora smanjiti za otprilike 25 do 50%.
English: Put the used pre-filled pen in the sharps disposal container immediately after use.
Croatian: Odložite iskorištenu brizgalicu u spremnik za odlaganje oštrih predmeta odmah nakon primjene.
English: • Additional risk minimisation measures for Aranesp solution for injection in pre-filled pen
Croatian: • Dodatne mjere minimizacije rizika za Aranesp otopinu za injekciju u napunjenoj brizgalici
English: Erythropoietin is a growth factor that primarily stimulates red blood cell production.
Croatian: Eritropoetin je čimbenik rasta koji primarno stimulira stvaranje crvenih krvnih stanica.
English: The pharmacokinetics of darbepoetin alfa has been studied clinically in chronic renal failure patients following intravenous and subcutaneous administration.
Croatian: Farmakokinetika darbepoetina alfa klinički je ispitivana u bolesnika s kroničnim zatajenjem bubrega tijekom intravenske i supkutane primjene.
English: For adult patients not on dialysis, 1.5 micrograms/kg once monthly may also be used as the initial dose.
Croatian: Za odrasle bolesnike koji nisu na dijalizi, kao početna doza može se primijeniti i 1,5 mikrograma/kg jednom mjesečno.
English: Leave the pre-filled syringe at room temperature for approximately 30 minutes.
Croatian: Ostavite napunjenu štrcaljku oko 30 minuta na sobnoj temperaturi.
English: During the evaluation period (weeks 29-33), the mean (95% CI) weekly equivalent dose was 0.20 (0.17, 0.24) mcg/kg in the once every two week arm and 0.27 (0.23, 0.32) mcg/kg in the once monthly arm.
Croatian: Tijekom razdoblja procjene (29.-33. tjedna), srednja vrijednost (95% CI) tjedne ekvivalentne doze iznosila je 0,20 (0,17, 0,24) μg/kg u skupini koja je primala dozu jednom svaka dva tjedna i 0,27 (0,23, 0,32) μg/kg u skupini koja je primala dozu jednom mjesečno.
English: It is unknown whether Aranesp is excreted in human milk.
Croatian: Nije poznato izlučuje li se Aranesp u majčino mlijeko.
English: In isolated cases, neutralising anti-erythropoietin antibody mediated pure red cell aplasia (PRCA) associated with Aranesp therapy have been reported predominantly in patients with CRF treated subcutaneously.
Croatian: U pojedinim slučajevima, izolirana aplazija crvenih krvnih stanica (PRCA) uzrokovana neutralizirajućim antieritropoetin antitijelima povezana s liječenjem lijekom Aranesp bila je prijavljivana uglavnom kod bolesnika s kroničnim zatajenjem bubrega liječenih supkutano.
English: With the grey cap off, place the pre-filled pen on your skin at 90 degrees.
Croatian: Napunjenu brizgalicu, kojoj ste prethodno skinuli sivi pokrov, postavite na kožu pod pravim kutom (90⁰).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku.
English: • Convulsions (fits and seizures)
Croatian: • konvulzije (napadaji)
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dL (6.2 mmol/L) to 12 g/dL (7.5 mmol/L).
Croatian: Varijabilnost hemoglobina treba riješiti prilagođavanjem doze, uzevši u obzir ciljni raspon hemoglobina od 10 g/dl (6,2 mmol/l) do 12 g/dl (7,5 mmol/l).
English: • an observed 9% increase in risk for PD or death in the epoetin alfa plus SOC group from a primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 10 to 12 g/dL (6.2 to 7.5 mmol/L).
Croatian: • opaženo povećanje rizika od 9% od progresivne bolesti ili smrti u skupini koja je primala epoetin alfa i standardnu zdravstvenu skrb iz primarne analize i povećanje rizika od 15% koje se ne može statistički isključiti u bolesnika s metastatskim karcinomom dojke koji primaju kemoterapiju kada se primjenjuje radi postizanja ciljne koncentracije hemoglobina od 10 do 12 g/dl (6,2 do 7,5 mmol/l).
English: Window Medicine Make sure the medicine in the window is a clear and colourless liquid.
Croatian: Provjerite da li je lijek vidljiv u prozoru bistra i bezbojna tekućina.
English: • New pre-filled pen
Croatian: • Novu napunjenu brizgalicu
English: In a clinical study in 124 paediatric patients with chronic kidney disease receiving or not receiving dialysis aged 1 to 18, patients that were stable on epoetin alfa were randomised to receive either darbepoetin alfa administered once weekly (subcutaneously or intravenously) using a dose conversion ratio of 238:1 or to continue with epoetin alfa therapy at the current dose, schedule, and route of administration.
Croatian: U kliničkom ispitivanju na 124 pedijatrijska bolesnika u dobi od 1 do 18 godina s kroničnom bolesti bubrega koji jesu ili nisu na dijalizi, bolesnici koji su bili stabilni na liječenju epoetinom alfa, randomizirani su kako bi primali ili darbepoetin alfa jednom tjedno (supkutano ili intravenski) prema omjeru konverzije doza 238:1, ili su nastavili s liječenjem epoetinom alfa u istoj dozi, rasporedu i putu primjene.
English: J Keep pushing down on your skin.
Croatian: Održavajte pritisak na kožu.
English: Do not put the grey needle cap back on used pre-filled syringes.
Croatian: Ne vraćajte sivi pokrov za iglu na iskorištenu štrcaljku.
English: • Cotton ball or gauze pad
Croatian: • Pamučnu vatu ili jastučić gaze
English: Half-life was also similar between adult and paediatric patients with CRF following both intravenous and subcutaneous administration.
Croatian: Poluvijek je također bio sličan kod odraslih i pedijatrijskih bolesnika s kroničnim zatajenjem bubrega nakon obje, intravenske i supkutane primjene.
English: Do not attempt to activate the pre-filled syringe prior to injection.
Croatian: Ne pokušavajte aktivirati napunjenu štrcaljku prije same injekcije.
English: If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Croatian: Ako nakon smanjenja doze hemoglobin nastavi rasti, mora se privremeno prekinuti liječenje dok se hemoglobin ne počne snižavati, te tada ponovo početi terapiju s dozom otprilike 25% nižom od prethodne.
English: If you feel unwell in any way you should contact your doctor, nurse or pharmacist immediately.
Croatian: Ne osjećate li se dobro na bilo koji način, obratite se odmah svojem liječniku, medicinskoj sestri ili ljekarniku.
English: The active substance of Aranesp is darbepoetin alfa produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Croatian: Djelatna tvar u lijeku Aranesp je darbepoetin alfa, proizveden genskom tehnologijom na jajnim stanicama kineskog hrčka (CHO-K1).
English: 980211) except for the adverse reaction of stroke which was identified as an adverse reaction in the TREAT
Croatian: 980117, 980202 i 980211), osim nuspojave moždanog udara koji je uočen kao nuspojava u ispitivanju TREAT
English: The pre-filled pen is designed to inject the area under your skin only.
Croatian: Napunjena brizgalica je dizajnirana za injiciranje samo ispod kože.
English: If the haemoglobin exceeds 12 g/dL (7.5 mmol/L), a dose reduction should be considered.
Croatian: Ako hemoglobin prijeđe 12 g/dl (7,5 mmol/l), treba uzeti u obzir smanjenje doze.
English: In a randomised, double-blind correction study (n = 358) comparing once every two week and once monthly dosing schedules in patients with CRF not on dialysis, darbepoetin alfa once monthly dosing was non-inferior to once every two week dosing for correcting anaemia.
Croatian: U randomiziranom dvostruko slijepom ispitivanju korekcije (n = 358) u kojem su se uspoređivali rasporedi doziranja jednom svaka dva tjedna i jednom mjesečno u bolesnika s kroničnim zatajenjem bubrega koji nisu na dijalizi, doziranje darbepoetina alfa jednom mjesečno nije bilo inferiorno doziranju jednom svaka dva tjedna za korekciju anemije.
English: There have been reports of serious hypersensitivity reactions including anaphylactic reaction, angioedema, allergic bronchospasm, skin rash and urticaria associated with darbepoetin alfa.
Croatian: Prijavljeni su izvještaji ozbiljnih reakcija preosjetljivosti uključujući anafilaktičku reakciju, angioedem, alergijski bronhospazam, kožni osip i urtikariju povezani s darbepoetinom alfa.
English: For all adults and paediatric patients ≥ 11 years of age not on dialysis, Aranesp could also be given as an injection once monthly.
Croatian: Svim odraslim i pedijatrijskim bolesnicima u dobi od ≥ 11 godina, koji nisu na dijalizi, Aranesp se također može davati kao injekcija jednom mjesečno.
English: • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dL (7.5-8.7 mmol/L).
Croatian: • skraćenje ukupnog preživljenja i povećanje smrtnosti povezane s napredovanjem bolesti do 4 mjeseca u bolesnika s metastatskim karcinomom dojke koji primaju kemoterapiju kod primjene radi ciljne koncentracije hemoglobina od 12-14 g/dl (7,5-8,7 mmol/l).
English: Leave the pre-filled pen at room temperature for at least 30 minutes before injecting.
Croatian: Ostavite brizgalicu na sobnoj temperaturi najmanje 30 minuta prije injiciranja.
English: • non-inferiority of darbepoetin alfa to placebo for overall survival and progression free survival in patients with advanced stage non-small cell lung cancer receiving chemotherapy when administered to a target haemoglobin of 12 g/dL (7.5 mmol/L) (see section 5.1).
Croatian: • neinferiornost darbepoetina alfa u odnosu na placebo za ukupno preživljenje i preživljenje bez progresije bolesti u bolesnika s uznapredovalim karcinomom pluća nemalih stanica koji primaju kemoterapiju, kada se primjenjuje radi postizanja ciljne koncentracije hemoglobina od 12 g/dl (7,5 mmol/l) (vidjeti dio 5.1).
English: Caution should be exercised with escalation of Aranesp doses in patients with chronic renal failure.
Croatian: Potreban je oprez s povećanjem doze lijeka Aranesp u bolesnika s kroničnim zatajenjem bubrega.
English: Active liver disease was an exclusion criteria in all studies of Aranesp, therefore no data are available from patients with impaired liver function.
Croatian: Ni u jedno ispitivanje lijeka Aranesp nisu bili uključeni bolesnici s aktivnom bolesti jetre pa stoga nema dostupnih podataka o bolesnicima s oštećenom funkcijom jetre.
English: • Avoid injecting into areas with scars or stretch marks.
Croatian: • Izbjegavajte područja s ožiljcima ili strijama.
English: Pure red cell aplasia
Croatian: Izolirana aplazija crvenih krvnih stanica
English: Step 3: Inject A Hold the pinch.
Croatian: Korak 3: Injiciranje A Držite nabor kože među prstima.
English: Aranesp is available in packs of 1 or 4 pre-filled syringes with automatic needle guard in a blister wrapping.
Croatian: Aranesp je dostupan u pakovanjima od 1 ili 4 napunjene štrcaljke s automatskim štitnikom za iglu u blisteru.
English: The initial dose by subcutaneous or intravenous administration is 0.45 mcg/kg body weight, as a single injection once weekly.
Croatian: Početna doza primijenjena supkutano ili intravenski je 0,45 μg/kg tjelesne težine, dana kao pojedinačna injekcija jednom tjedno.
English: At the time haemoglobin ≥ 10.0 g/dL was first achieved, the mean (SD) weightadjusted dose was 0.48 (0.24) mcg/kg (range: 0.0 to 1.7 mcg/kg) weekly for the once weekly group and 0.76 (0.21) mcg/kg (range: 0.3 to 1.5 mcg/kg) biweekly for the once every two week group.
Croatian: Kada je prvi put postignuta vrijednost hemoglobina ≥ 10,0 g/dl, srednja (SD) doza prilagođena za tjelesnu težinu iznosila je 0,48 (0,24) μg/kg (raspon: 0,0 do 1,7 μg/kg) jednom tjedno, za one bolesnike koji su lijek primjenjivali jednom tjedno te 0,76 (0,21) μg/kg (raspon:
English: d Dialysis vascular access thrombosis includes all adverse reactions under the dialysis vascular access thrombosis
Croatian: d Tromboza u vaskularnom pristupu za dijalizu uključuje sve nuspojave navedene u Amgen MedDRA upitu
English: • A demonstration device
Croatian: • Pokazni uređaj
English: Aranesp should also be used with caution in those patients with sickle cell anaemia.
Croatian: Aranesp također uz oprez treba davati i bolesnicima koji boluju od anemije srpastih stanica.
English: Aranesp should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L).
Croatian: Aranesp treba primijeniti supkutano ili intravenski kako bi se hemoglobin povisio na vrijednost koja nije veća od 12 g/dl (7,5 mmol/l).
English: Cases of severe hypertension have been observed following overdose with Aranesp (see section 4.4).
Croatian: Slučajevi teške hipertenzije zapaženi su nakon predoziranja lijekom Aranesp (vidjeti dio 4.4).
English: The frequency of all hypersensitivity reactions was estimated from clinical trial data as very common in cancer patients.
Croatian: Učestalost svih reakcija preosjetljivosti je procijenjena iz podataka kliničkog ispitivanja kao vrlo česta kod bolesnika s rakom.
English: In a prospective, randomised double-blind, placebo-controlled study conducted in 344 anaemic patients with lymphoproliferative malignancies receiving chemotherapy there was a significant reduction in transfusion requirements and an improvement in haemoglobin response (p < 0.001).
Croatian: U prospektivnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju provedenom na 344 anemična bolesnika s limfoproliferativnim malignomima koji su primali kemoterapiju, zabilježeno je znatno smanjenje potreba za transfuzijom i poboljšanje hemoglobinskog odgovora (p < 0,001).
English: The needle cap of the pre-filled syringe or pre-filled pen contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Croatian: Pokrov igle napunjene štrcaljke ili napunjene brizgalice sadrži suhu prirodnu gumu (derivat lateksa) koja može izazvati alergijske reakcije.
English: Your doctor has prescribed an Aranesp pre-filled syringe for injection into the tissue just under the skin.
Croatian: Liječnik je propisao Aranesp napunjenu štrcaljku za injiciranje u tkivo odmah ispod kože.
English: Please tell your doctor if you are suffering or have suffered from: - high blood pressure which is being controlled with medicines prescribed by your doctor; - sickle cell anaemia; - epileptic fits (seizures); - convulsions (fits or seizures); - liver disease; - significant lack of response to medicines used to treat anaemia; or - hepatitis C.
Croatian: Molimo obavijestite svojeg liječnika, ako bolujete ili ste bolovali od: - visokog krvnog tlaka koji je kontroliran lijekovima koje Vam je propisao liječnik, - anemije srpastih stanica, - epileptičkih napadaja, - konvulzija (napadaji), - bolesti jetre, - značajnog manjka odgovora na lijekove za liječenje anemije, - hepatitisa C.
English: Incidence of adverse reactions are listed below by system organ class and frequency.
Croatian: Incidencija nuspojava je navedena u nastavku prema klasifikaciji organskih sustava i učestalosti.
English: The terminal half-life of darbepoetin alfa is 21 hours (SD 7.5) when administered intravenously.
Croatian: Kod intravenske primjene terminalni poluvijek darbepoetina alfa je 21 sat (SD 7,5).
English: A Discard the used pre-filled syringe and other supplies in a sharps disposal container.
Croatian: Odložite iskorištenu štrcaljku i ostali pribor u spremnik za odlaganje oštrih predmeta.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRAY FOR PRE-FILLED SYRINGE WITH NEEDLE GUARD
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PODLOŽAK ZA NAPUNJENU ŠTRCALJKU SA ŠTITNIKOM ZA IGLU
English: b Thromboembolic events adverse reactions includes PT embolism, thrombosis, deep vein thrombosis, jugular vein thrombosis, venous thrombosis, arterial thrombosis, pelvic venous thrombosis, peripheral embolism, pulmonary embolism, as well as thrombosis in device from SOC product issues.
Croatian: b Nuspojave tromboembolijski događaji uključuju sljedeće preporučene pojmove: embolija, tromboza, duboka venska tromboza, tromboza jugularne vene, venska tromboza, arterijska tromboza, tromboza zdjeličnih vena, periferna embolija, plućna embolija, kao i tromboza u uređaju iz klasifikacije organskih sustava „Problemi s lijekom/medicinskim proizvodom“.
English: Serum potassium levels should be monitored regularly during Aranesp therapy.
Croatian: Tijekom terapije lijekom Aranesp mora se redovito mjeriti razina kalija u serumu.
English: Please tell your doctor if you are suffering or have suffered from: - high blood pressure which is being controlled with medicines prescribed by your doctor; - sickle cell anaemia; - epileptic fits (seizures); - convulsions (fits or seizures); - liver disease; - significant lack of response to medicines used to treat anaemia; - an allergy to latex (the needle cap on the pre-filled syringe contains a derivative of latex); or - hepatitis C.
Croatian: Molimo obavijestite svojeg liječnika, ako bolujete ili ste bolovali od: - visokog krvnog tlaka koji je kontroliran lijekovima koje Vam je propisao liječnik, - anemije srpastih stanica, - epileptičkih napadaja, - konvulzija (napadaji), - bolesti jetre, - značajnog manjka odgovora na lijekove za liječenje anemije, - alergije na lateks (pokrov igle napunjene štrcaljke sadrži derivat lateksa), ili - hepatitisa C.
English: When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Croatian: Kad se Aranesp zamjenjuje za r-HuEPO, hemoglobin se mora mjeriti svaki tjedan ili svaka dva tjedna uz isti put primjene.
English: Cases of severe hypertension, including hypertensive crisis, hypertensive encephalopathy, and seizures, have been observed in CRF patients treated with Aranesp.
Croatian: Slučajevi teške hipertenzije, uključujući hipertenzivne krize, hipertenzivnu encefalopatiju i napadaje primijećeni su kod bolesnika s kroničnim zatajenjem bubrega koji su liječeni lijekom Aranesp.
English: Do not put the grey cap back onto the pre-filled pen.
Croatian: Nemojte ponovno stavljati sivi pokrov natrag na napunjenu brizgalicu.
English: Hypertension has been observed in cancer patients in post-marketing experience (see section 4.4).
Croatian: Hipertenzija je primijećena kod bolesnika s rakom nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: • Keep the pre-filled pen in the outer carton in order to protect from light or physical damage.
Croatian: • Čuvajte napunjenu brizgalicu u vanjskom pakiranju radi zaštite od svjetlosti i fizičkog oštećenja.
English: It must be a clear, colourless or slightly pearly liquid.
Croatian: Tekućina mora biti bistra, bezbojna ili blago biserna.
English: Do not use the pre-filled pen if the expiry date printed after EXP on the label has passed.
Croatian: Ne upotrebljavajte napunjenu brizgalicu ako je rok valjanosti naveden iza oznake „EXP“ na naljepnici istekao.
English: Talk with your healthcare provider about proper disposal.
Croatian: Pitajte svog zdravstvenog radnika kako ih pravilno zbrinuti.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported (see section 4.4).
Croatian: Prijavljene su teške nuspojave na koži (SCARs), uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), koje mogu biti po život opasne ili smrtonosne (vidjeti dio 4.4).
English: Avoid injecting into areas with scars or stretch marks.
Croatian: Izbjegavajte područja s ožiljcima ili strijama.
English: The syringes are provided either with (1- and 4-pack) or without (1-pack) a blister-wrapping.
Croatian: Štrcaljke su dostupne u blisterima (pakiranja od 1 i 4) ili bez blistera (pakiranje od 1).
English: The mean haemoglobin for r-HuEPO and darbepoetin alfa at baseline was 11.1 (SD 0.7) g/dL and 11.3 (SD 0.6) g/dL, respectively.
Croatian: Srednja vrijednost hemoglobina za r-HuEPO na početku ispitivanja iznosila je 11,1 (SD 0,7) g/dl, a za darbepoetin alfa 11,3 (SD 0,6) g/dl.
English: For patients ≥ 1 year of age, the initial dose by subcutaneous or intravenous administration is 0.45 mcg/kg body weight, as a single injection once weekly.
Croatian: Za pedijatrijske bolesnike u dobi od 1 godine i starije, početna doza primijenjena supkutano ili intravenski je 0,45 μg/kg tjelesne težine, dana kao pojedinačna injekcija jednom tjedno.
English: Do not use the pre-filled syringe if it has been dropped on a hard surface.
Croatian: Ne upotrebljavajte napunjenu brizgalicu ako je pala na tvrdu površinu.
English: Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Croatian: Liječenje simptomatske anemije u odraslih osoba koje boluju od nemijeloične maligne bolesti i primaju kemoterapiju.
English: Patients with solid tumours (e.g., lung, breast, colon, ovarian cancers) and lymphoid malignancies
Croatian: Bolesnici sa solidnim tumorima (npr. rak pluća, dojke, kolona, jajnika) i limfoidnim malignomima (npr. limfom, multipli mijelom) bili su uključeni u klinička ispitivanja.
English: Excipients: sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80, water for injections.
Croatian: Pomoćne tvari: natrijev dihidrogenfosfat, natrijev hidrogenfosfat, natrijev klorid, polisorbat 80 i voda za injekcije.
English: - The other ingredients are sodium phosphate monobasic, sodium phosphate dibasic, sodium chloride, polysorbate 80 and water for injections.
Croatian: - Pomoćne tvari su natrijev dihidrogenfosfat, natrijev hidrogenfosfat, natrijev klorid, polisorbat 80 i voda za injekcije.
English: Rotate the injection sites to avoid discomfort at the site of injection.
Croatian: Treba mijenjati mjesto injiciranja kako bi se izbjegla neugoda na mjestu primjene.
English: Marketing Authorisation Holder and Manufacturer Amgen Europe B.V.
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka i proizvođač Amgen Europe B.V.
English: In the once every three weeks group, 72% of patients required dose reductions.
Croatian: U skupini koja je dobivala Aranesp jednom u 3 tjedna kod 72% bolesnika bilo je potrebno smanjiti dozu.
English: In a randomised, double-blind, placebo-controlled phase 3 study 2,549 adult patients with anaemia receiving chemotherapy for the treatment of advanced stage non-small cell lung cancer (NSCLC), were randomised 2:1 to darbepoetin alfa or placebo and treated to a maximum Hb of 12 g/dL.
Croatian: U randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju faze 3, 2549 odraslih bolesnika s anemijom koji su primali kemoterapiju za liječenje uznapredovalog karcinoma pluća nemalih stanica (NSCLC) randomizirano je u omjeru 2:1 za primanje darbepoetina alfa ili placeba i liječeno je do maksimalnog hemoglobina od 12 g/dl.
English: Keep the syringe and sharps disposal container out of sight and reach of children.
Croatian: Čuvajte spremnik za odlaganje štrcaljke i oštrih predmeta izvan pogleda i dohvata djece.
English: Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with ESAs, including Aranesp.
Croatian: Zabilježena je povezanost izolirane aplazije crvenih stanica uzrokovane neutralizirajućim antieritropoetinskim antitijelima s LSE, uključujući Aranesp.
English: If an elevated or rising potassium level is observed then consideration should be given to ceasing Aranesp administration until the level has been corrected.
Croatian: Ako se primijeti povišena razina kalija ili njegov porast, treba uzeti u obzir prekid primjene lijeka Aranesp dok se razina kalija ne popravi.