FrancophonIA/ELRC3.0 huggingface dataset:
English: Slowly push the plunger with the thumb while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected.
Croatian: Palcem polako pritisnite klip, držeći štrcaljku kažiprstom i srednjakom koji su prislonjeni uz hvatište za prste, sve dok ne injicirate sav lijek.
English: Uncommon side effects (may affect up to 1 in 100 pleople) are:
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) su:
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 section 4.2 and section 4.4).
Croatian: Primijećena je tendencija povećanja procijenjenog rizika od smrti zbog bilo kojeg uzroka te kardiovaskularnih i cerebrovaskularnih događaja povezanih s višim kumulativnim dozama lijekova za stimulaciju eritropoeze, neovisno o dijabetesu i statusu dijalize (vidjeti dijelove 4.2 i 4.4).
English: MIRCERA can be injected under the skin in the abdomen, arm or thigh; or into a vein.
Croatian: MIRCERA se može injicirati pod kožu u predjelu trbuha, nadlaktice ili bedra, ili pak u venu.
English: Following intravenous administration to CKD patients on dialysis, the total systemic clearance was 0.494 ml/h per kg.
Croatian: Nakon intravenske primjene u bolesnika s kroničnom bolesti bubrega na dijalizi ukupni sistemski klirens iznosio je 0,494 ml/h po kilogramu.
English: The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 62% and the observed terminal elimination half-life was 139 hours in CKD patients on dialysis.
Croatian: Apsolutna bioraspoloživost metoksi polietilenglikol-epoetina beta nakon supkutane primjene bila je 62%, a opaženo terminalno poluvrijeme eliminacije iznosilo je 139 sati u bolesnika s kroničnom bolesti bubrega na dijalizi.
English: Cleansing alcohol swabs
Croatian: Tupferi natopljeni alkoholom za čišćenje
English: In case of excessive haemoglobin levels, treatment with MIRCERA should be temporarily discontinued (see section 4.2).
Croatian: Ako se razina hemoglobina previsoka, privremeno treba prekinuti liječenje lijekom MIRCERA (vidjeti dio 4.2).
English: The median time to response was 43 days in the MIRCERA arm and 29 days in the comparator arm, with increases of haemoglobin within the first 6 weeks of 0.2 g/dl/week and 0.3 g/dl/week, respectively.
Croatian: Medijan vremena do odgovora je iznosio 43 dana u skupini koja je primala lijek MIRCERA i 29 dana u skupini koja je primala usporedni lijek, uz povećanje hemoglobina u prvih 6 tjedana od 0,2 g/dl tjedno, odnosno 0,3 g/dl tjedno.
English: The dose is to be administered once every two weeks as a single injection under the skin or into a vein.
Croatian: Dozu treba primjenjivati jedanput svaka dva tjedna jednom injekcijom pod kožu ili u venu.
English: Name and address of the manufacturer responsible for batch release for the pre-filled syringes
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u napunjenim štrcaljkama u promet
English: Push the plunger with the thumb while holding the syringe with the forefinger and the middle finger against the finger grips until all the medicine is injected.
Croatian: Palcem pritisnite klip, držeći štrcaljku kažiprstom i srednjakom koji su prislonjeni uz hvatište za prste, sve dok ne injicirate sav lijek.
English: • The other ingredients are sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, poloxamer 188 and water for injections.
Croatian: • Drugi sastojci su natrijev dihidrogenfosfat hidrat, natrijev sulfat, manitol (E421), metionin, poloksamer 188 i voda za injekcije.
English: 4.2 Posology and method of administration.
Croatian: 4.2 Doziranje i način primjene
English: Release the plunger, allowing the needle guard to protect the needle.
Croatian: Otpustite klip i dopustite da zaštitni pokrov prekrije iglu.
English: Failure to respond to MIRCERA therapy should prompt for a search for causative factors.
Croatian: Izostanak odgovora na terapiju lijekom MIRCERA treba odmah ispitati kako bi se pronašli uzročni čimbenici.
English: · Do not push the plunger.
Croatian: • Nemojte pritiskati klip.
English: If you develop a serious rash or another of these skin symptoms stop taking Mircera and contact your doctor or seek medical attention immediately.
Croatian: U slučaju nastanka ozbiljnog osipa ili drugih kožnih simptoma, prestanite uzimati lijek Mircera i odmah se obratite svojem liječniku ili potražite medicinsku pomoć.
English: Remove the plastic tray of the MIRCERA pre-filled syringe from the box without peeling back the protective film.
Croatian: Izvadite plastičnu pliticu s MIRCERA napunjenom štrcaljkom iz kutije, ali nemojte skinuti zaštitnu foliju.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se podnošenje periodičkog izvješća o neškodljivosti (PSUR) podudara s ažuriranim verzijama RMP-a, oba dokumenta mogu biti podnesena istodobno.
English: Sterile cotton ball or gauze Puncture-resistant container or sharps container for safe disposal of needle and used syringe
Croatian: Neprobojni spremnik ili spremnik za oštre predmete za sigurno odlaganje igle i upotrijebljene štrcaljke
English: A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four-week period should be avoided.
Croatian: Treba izbjegavati porast hemoglobina veći od 2 g/dl (1,24 mmol/l) tijekom 4 tjedna.
English: Physical, cognitive, or sexual developments in the offspring of mothers receiving methoxy polyethylene glycol-epoetin beta during gestation and lactation were not affected.
Croatian: Nije bilo utjecaja na fizički, kognitivni niti reproduktivni razvoj potomaka čije su majke primale metoksi polietilenglikol-epoetin beta tijekom gestacije i dojenja.
English: MIRCERA stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow.
Croatian: MIRCERA potiče eritropoezu interakcijom s eritropoetinskim receptorima na progenitorskim stanicama u koštanoj srži.
English: Sodium dihydrogen phosphate monohydrate, sodium sulphate, mannitol (E421), methionine, poloxamer 188 and water for injections.
Croatian: Natrijev dihidrogenfosfat hidrat, natrijev sulfat, manitol (E421), metionin, poloksamer 188 i voda za injekcije.
English: · Never reattach the needle shield after removal.
Croatian: • Nikada nemojte vraćati zaštitni pokrov na iglu nakon što ga skinete.
English: Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins.
Croatian: U bolesnika koji nisu na hemodijalizi poželjnija je supkutana primjena radi izbjegavanja uboda u periferne vene.
English: After initiation of therapy, your doctor will seek to maintain your haemoglobin level between 10 and 12 g/dl (7.45 mmol/l).
Croatian: Nakon početka terapije, liječnik će Vam razinu hemoglobina nastojati održavati između 10 i 12 g/dl (7,45 mmol/l).
English: If all the conditions mentioned are excluded and the patient has a sudden drop of haemoglobin associated with reticulocytopenia and anti-erythropoietin antibodies, examination of the bone marrow for the diagnosis of Pure Red Cell Aplasia (PRCA) should be considered.
Croatian: Ako se isključe sva navedena stanja, a u bolesnika dođe do iznenadnog pada hemoglobina povezanog s retikulocitopenijom i antieritropoetinskim antitijelima, treba napraviti pretrage koštane srži da bi se utvrdilo postoji li izolirana aplazija crvene krvne loze (engl.
English: · The expiration date has passed.
Croatian: • ako je istekao rok valjanosti
English: Data from a controlled clinical trial with epoetin alfa or darbepoetin alfa reported an incidence of stroke as common.
Croatian: Prema podacima iz kontroliranog kliničkog ispitivanja s epoetinom alfa odnosno darbepoetinom alfa, incidencija moždanoga udara bila je česta.
English: The absolute bioavailability of methoxy polyethylene glycol-epoetin beta after subcutaneous administration was 54%.
Croatian: Apsolutna bioraspoloživost metoksi polietilenglikol-epoetina beta nakon supkutane primjene bila je 54%.
English: · Do not throw away used syringes or the sharps/ puncture-resistant container in household trash and do not recycle them.
Croatian: • Nemojte baciti upotrijebljene štrcaljke ili spremnik za oštre predmete/neprobojni spremnik u kućni otpad i nemojte ih reciklirati.
English: MIRCERA is available, for all strengths, in pack sizes of 1 and also packsize of 3 for the strengths 30, 50, 75 micrograms/0.3ml.
Croatian: MIRCERA je u svim dozama dostupna u pakiranjima od 1 napunjene štrcaljke te u pakiranju od 3 napunjene štrcaljke samo za doze od 30, 50, 75 mikrograma/0,3 ml.
English: If one dose of MIRCERA is missed, the missed dose is to be administered as soon as possible and administration of MIRCERA is to be restarted at the prescribed dosing frequency.
Croatian: Ako se propusti jedna doza lijeka MIRCERA, propuštenu dozu treba primijeniti što je prije moguće, a zatim nastaviti primjenu lijeka MIRCERA u propisanim intervalima.
English: The safety data base from clinical trials comprised 3,042 CKD patients, including 1,939 patients treated with MIRCERA and 1,103 with another ESA.
Croatian: Podaci o sigurnosti prikupljeni tijekom kliničkih ispitivanja dobiveni su od 3042 bolesnika s kroničnom bolesti bubrega, od čega je 1939 bolesnika liječeno lijekom MIRCERA, a 1103 nekim drugim LSE.
English: Treatment with MIRCERA has to be initiated under the supervision of a physician experienced in the management of patients with renal impairment.
Croatian: Liječenje lijekom MIRCERA mora započeti pod nadzorom liječnika s iskustvom u liječenju bolesnika s narušenom funkcijom bubrega.
English: Platelet counts below 100 x 109/l were observed in 7% of patients treated with MIRCERA and 4% of patients treated with other ESAs during clinical development.
Croatian: Broj trombocita niži od 100 x 109/l opažen je u 7% bolesnika liječenih lijekom MIRCERA i 4% bolesnika liječenih drugim LSE.
English: No dose adjustment is required in patients aged 65 years or older.
Croatian: Za bolesnike starije od 65 godina nije potrebna prilagodba doze.
English: The first MIRCERA dose will be given on the planned injection day of your previous medicine.
Croatian: Prva doza lijeka MIRCERA primijenit će se na dan planirane primjene prethodnog lijeka.
English: Patients treated once every two weeks whose haemoglobin concentration is above 10 g/dl (6.21 mmol/l) may receive MIRCERA administered once-monthly using the dose equal to twice the previous once-every-two-week dose.
Croatian: Bolesnici liječeni jedanput svaka dva tjedna čija je koncentracija hemoglobina iznad 10 g/dl (6,21 mmol/l), mogu primiti lijek MIRCERA jedanput mjesečno u dozi dvostruko većoj od one koja je prethodno primjenjivana jedanput svaka dva tjedna.
English: Further increases of approximately 25% may be made at monthly intervals until the individual target haemoglobin level is obtained.
Croatian: Svakih mjesec dana doza se smije povećavati za daljnjih 25% dok se ne postignu ciljne vrijednosti hemoglobina za pojedinog bolesnika.
English: In responding to hypoxia, the natural hormone erythropoietin interacts with erythroid progenitor cells to increase red cell production.
Croatian: Odgovarajući na hipoksiju prirodni hormon eritropoetin djeluje na eritroidne progenitorske stanice kako bi se povećala proizvodnja crvenih krvnih stanica.
English: These antibodies have been shown to cross-react with all ESAs, and patients suspected or confirmed to have antibodies to erythropoietin should not be switched to MIRCERA (see section 4.8).
Croatian: Utvrđeno je da ta antitijela križno reagiraju sa svim lijekovima za stimulaciju eritropoeze pa bolesnici za koje se sumnja ili za koje je potvrđeno da imaju antitijela na eritropoetin ne smiju prelaziti na liječenje lijekom MIRCERA (vidjeti dio 4.8).
English: Prefilled syringes 30, 50, 75 micrograms are available in pack size of 1 or 3 pre-filled syringe(s).
Croatian: Napunjene štrcaljke od 30, 50 i 75 mikrograma dostupne su u veličini pakiranja od 1 ili 3 napunjene štrcaljke.
English: Pre-filled syringe (type I glass) with laminated plunger stopper (bromobutyl rubber) and tip cap (bromobutyl rubber) and a needle 27G1/2.
Croatian: Napunjena štrcaljka (staklo tipa I) s laminiranim čepom klipa (brombutil guma) i zatvaračem vrha (brombutil guma) te jedna igla 27G1/2.
English: In case PRCA is diagnosed, therapy with MIRCERA must be discontinued and patients should not be switched to another ESA.
Croatian: Ako se dijagnosticira PRCA, terapija lijekom MIRCERA mora se prekinuti, a bolesnike se ne smije prebaciti na liječenje nekim drugim LSE.
English: Your doctor will carry out regular blood tests to monitor how your anaemia is responding to treatment by measuring your haemoglobin level.
Croatian: Liječnik će Vas redovito slati na krvne pretrage kako bi uz pomoć izmjerenih vrijednosti razine hemoglobina pratio kako se Vaša anemija odgovara na liječenje.
English: Remove the needle shield and prepare for injection
Croatian: Korak 5. Skinite zaštitni pokrov igle i pripremite se za injekciju
English: If you are advised to inject MIRCERA under your skin, please administer your dose as described below.
Croatian: Ako Vam je zdravstveni radnik savjetovao da lijek MIRCERA injicirate pod kožu, molimo primijenite dozu na način opisan u nastavku.
English: You may remove your MIRCERA pre-filled syringe from the refrigerator and store it at a room temperature not above 30 °C for a single period of one month.
Croatian: MIRCERA napunjenu štrcaljku možete izvaditi iz hladnjaka i čuvati je na sobnoj temperaturi do 30°C u trajanju do mjesec dana.
English: In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epoetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
Croatian: U ispitivanju jednokratne doze, farmakokinetika metoksi polietilenglikol-epoetina beta nakon intravenske primjene bila je slična u bolesnika s teškim oštećenjem funkcije jetre i u zdravih ispitanika (vidjeti dio 4.2).
English: If you forget to use MIRCERA
Croatian: Ako ste zaboravili primiti lijek MIRCERA
English: Perform the injection
Croatian: Korak 6. Primijenite injekciju
English: To remove air bubbles from the prefilled syringe, hold the syringe with the needle pointing up.
Croatian: Da biste uklonili mjehuriće zraka iz napunjene štrcaljke, držite štrcaljku iglom okrenutom prema gore.
English: Pulmonary embolism*
Croatian: rijetko plućna embolija*
English: Package leaflet: Information for the user
Croatian: Uputa o lijeku: Informacije za korisnika MIRCERA
English: Previous weekly epoetin intravenous or subcutaneous dose (IU/week)
Croatian: Prethodna tjedna doza epoetina intravenski ili supkutano (i.j./tjedan)
English: · Do not remove the needle shield that protects the needle.
Croatian: • Nemojte skinuti pokrov za iglu koji štiti iglu.
English: It did not induce a proliferative response in non-haematological tumor cell lines in vitro.
Croatian: Lijek in vitro nije poticao proliferaciju staničnih linija nehematoloških tumora.
English: One animal study has shown excretion of methoxy polyethylene glycol-epoetin beta in maternal milk.
Croatian: Jedno ispitivanje na životinjama pokazalo je da se metoksi polietilenglikol-epoetin beta izlučuje u mlijeko ženki.
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see section 4.2 and 5.1).
Croatian: U bolesnika sa slabim hemoglobinskim odgovorom na epoetine potrebno je razmotriti druga moguća objašnjenja slabog odgovora (vidjeti dijelove 4.2 i 5.1).
English: Break the seal of the needle, using a twisting motion, and remove the needle cap as pictured.
Croatian: Prelomite spoj igle kružnim pokretom i uklonite zatvarač igle kako je prikazano na slici.
English: The first injection should start at the next scheduled dose of the previously administered darbepoetin alfa or epoetin.
Croatian: Prvu injekciju treba primijeniti u planiranom terminu sljedeće doze darbepoetina alfa ili epoetina.
English: Patients with hepatic impairment
Croatian: Bolesnici s oštećenom funkcijom jetre
English: You will not receive another ESA and your doctor will treat you for this condition.
Croatian: Nećete dobivati drugi lijek za stimulaciju eritropoeze, a liječnik će Vam propisati terapiju za ovo stanje.
English: Do not use MIRCERA
Croatian: Nemojte primati lijek MIRCERA
English: STORAGE Keep the syringe and the puncture-resistant/ sharps container out of the reach of children.
Croatian: Čuvajte štrcaljku i neprobojan spremnik/spremnik za oštre predmete izvan dohvata djece.
English: Methoxy polyethylene glycol-epoetin beta, the active substance of MIRCERA, is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin.
Croatian: U usporedbi s eritropoetinom, pokazuje različitu aktivnost na razini receptora koju karakterizira sporija asocijacija i brža disocijacija s receptora, smanjena specifična aktivnost in vitro i povećana aktivnost in vivo te dulji poluvijek.
English: MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2.
Croatian: MIRCERA je dostupna u napunjenim štrcaljkama s laminiranim čepom klipa i zatvaračem vrha te s jednom iglom 27G1/2.
English: · Never pull on or handle the syringe by its plunger.
Croatian: • Nikada nemojte štrcaljku vući za klip niti rukovati njome držeći je za klip.
English: Before treatment with MIRCERA
Croatian: Prije liječenja lijekom MIRCERA
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l).
Croatian: Fluktuaciju hemoglobina treba rješavati korekcijom doze, uzimajući u obzir da je ciljni raspon hemoglobina od 10 g/dl (6,21 mmol/l) do 12 g/dl (7,45 mmol/l).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous or intravenous use Read the package leaflet before use Do not shake
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za supkutanu ili intravensku primjenu Prije uporabe pročitajte uputu o lijeku Ne tresti
English: In a post-authorisation safety study with long treatment exposure of up to 8.4 years, baseline platelet counts below 100 x 109/l was present in 2.1% of patients in the MIRCERA group and 2.4% of patients in other ESAs group.
Croatian: U ispitivanju sigurnosti nakon dobivanja odobrenja, u kojem se ispitivala sigurnost lijeka kod dugoročne izloženosti (do 8,4 godine), početni broj trombocita niži od 100 x 109/l bio je prisutan u 2,1% bolesnika u skupini liječenoj lijekom MIRCERA i u 2,4% bolesnika u skupini koja je primala druge lijekove za stimulaciju eritropoeze.
English: The pharmacokinetics of methoxy polyethylene glycol-epoetin beta were studied in healthy volunteers and in anaemic patients with CKD including patients on dialysis and not on dialysis.
Croatian: Farmakokinetika metoksi polietilenglikol-epoetina beta je ispitivana u zdravih dobrovoljnih ispitanika te anemičnih bolesnika s kroničnom bolesti bubrega na dijalizi i onih koji nisu na dijalizi.
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 openlabel study.
Croatian: Preživljenje i napredovanje tumora ispitivani su u pet velikih kontroliranih studija koje su uključivale ukupno 2833 bolesnika.
English: The elimination half-life after intravenous administration of methoxy polyethylene glycol-epoetin beta is 134 hours.
Croatian: Poluvrijeme eliminacije metoksi polietilenglikol-epoetina beta nakon intravenske primjene iznosi 134 sata.
English: Following subcutaneous administration to CKD patients on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) after administration.
Croatian: Nakon supkutane primjene u bolesnika s kroničnom bolesti bubrega na dijalizi, maksimalne koncentracije metoksi polietilenglikol-epoetina beta u serumu opažene su 72 sata (medijan vrijednosti) nakon primjene.
English: Caution should be exercised with escalation of MIRCERA doses in patients with chronic renal failure.
Croatian: Potreban je oprez prilikom povećanja doza lijeka MIRCERA u bolesnika s kroničnim zatajenjem bubrega.
English: Keep the pre-filled syringe in the outer carton in order to protect from light
Croatian: Napunjenu štrcaljku čuvajte u vanjskom pakiranju radi zaštite od svjetlosti
English: Prefilled syringes 40, 60, 100, 120, 150, 200, 250 and 360 micrograms are available in pack size of 1 pre-filled syringe.
Croatian: Napunjene štrcaljke od 40, 60, 100, 120, 150, 200, 250 i 360 mikrograma dostupne su u veličini pakiranja od 1 napunjene štrcaljke.
English: • hot flush
Croatian: • naleti vrućine
English: Misuse of MIRCERA by healthy people may lead to an excessive increase in haemoglobin.
Croatian: Zlouporaba lijeka MIRCERA u zdravih osoba može dovesti do prekomjernog povećanja razine hemoglobina što može uzrokovati po život opasne kardiovaskularne komplikacije.
English: MIRCERA should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/dl (7.45 mmol/l).
Croatian: Lijek MIRCERA treba davati supkutano ili intravenski da bi se razina hemoglobina povećala na razinu koja nije viša od 12 g/dl (7,45 mmol/l).
English: As with other ESAs, cases of thrombosis, including pulmonary embolism, have been reported in the post-marketing setting (see section 4.4).
Croatian: Kao i kod ostalih LSE, nakon puštanja lijeka u promet zabilježeni su slučajevi tromboze, uključujući plućnu emboliju (vidjeti dio 4.4).
English: · Do not inject areas that could be irritated by a belt or waistband.
Croatian: • Nemojte injicirati lijek na područja koja bi mogao nadražiti remen ili elastični pojas.
English: In patients with a poor haemoglobin response to MIRCERA, alternative explanations for the poor response should be considered (see section 4.4 and 5.1).
Croatian: U bolesnika sa slabim hemoglobinskim odgovorom na lijek MIRCERA potrebno je razmotriti druga moguća objašnjenja slabog odgovora (vidjeti dijelove 4.4 i 5.1).
English: Roche Pharma AG Emil-Barrell-Strasse 1 D-79639 Grenzach-Wyhlen Germany
Croatian: Roche Pharma AG Emil-Barrell-Strasse 1 D-79639 Grenzach-Wyhlen Njemačka
English: One pre-filled syringe contains: 30, 40, 50, 60, 75, 100, 120, 150, 200 or 250 micrograms in 0.3 ml and 360 micrograms in 0.6 ml.
Croatian: Jedna napunjena štrcaljka sadrži 30, 40, 50, 60, 75, 100, 120, 150, 200 ili 250 mikrograma u 0,3 ml otopine i 360 mikrograma u 0,6 ml otopine.
English: Each pre-filled syringe contains 0.3 ml or 0.6 ml.
Croatian: Jedna napunjena štrcaljka sadrži 0,3 ml ili 0,6 ml otopine.
English: Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with all ESAs, including MIRCERA.
Croatian: Izolirana aplazija crvene krvne loze prouzročena antieritropoetinskim antitijelima zabilježena je uz sve LSE, uključujući lijek MIRCERA.
English: Hypersensitivity reactions, including cases of anaphylactic reaction and serious skin rashes including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis have been reported in association with epoetin treatement.
Croatian: Prijavljivane su reakcije preosjetljivosti, uključujući slučajeve anafilaktičke reakcije i ozbiljne kožne osipe, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, povezani s liječenjem epoetinom.
English: Fully insert the needle into the skin in a quick, “dart-like” motion.
Croatian: Ubodite iglu do kraja u kožu brzim pokretom, poput strelice.