FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 4 week repeated dose toxicity study in rats after a recovery of 26 weeks hepatic changes (focal or multifocal haemorrhage, hemorrhagic necrosis, chronic inflammation, and/or bile duct hyperplasia) were seen in the female animals (the cumulative HED of the dose groups compares to a safety multiple of 5.1 and 10.5 to the cumulative human therapeutic dose (2 x 510 mg Fe) in a 60 kg human).
Croatian: U 4-tjednom ispitivanju toksičnosti ponovljenih doza na štakorima nakon oporavka od 26 tjedana, promjene na jetri (fokalno ili multifokalno krvarenje, hemoragijska nekroza, kronična upala i/ili hiperplazija žučovoda) bile su viđene kod ženki (kumulativni HED doznih skupina može se usporediti sa sigurnosnim višekratnikom od 5,1 i 10,5 kumulativne terapijske doze kod ljudi (2 x 510 mg Fe) kod osoba tjelesne težine 60 kg).
English: For patients receiving haemodialysis, Rienso should be administered once the blood pressure is stable and the patient has completed at least one hour of haemodialysis.
Croatian: Kod bolesnika na hemodijalizi, Rienso treba primijeniti nakon što krvni tlak postane stabilan i bolesnik je proveo barem jedan sat na hemodijalizi.
English: The iron is then released intracellularly from the iron-carbohydrate complex within vesicles in macrophages.
Croatian: Željezo se potom inatracelularno oslobađa iz kompleksa željeza i ugljikohidrata unutar vezikula u makrofagima.
English: Any suspected adverse reactions should be reported via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
English: 1 ml contains 30 mg of iron.
Croatian: TVARI 1 ml sadrži 30 mg željeza.
English: The estimated values of CL and Vd following two 510 mg doses of Rienso administered intravenously within 24 hours were 69.1 ml/hr and 3.3 l, respectively.
Croatian: Procijenjena vrijednost klirensa nakon dvije doze lijeka Rienso od 510 mg primijenjene intravenski unutar 24 sata iznosila je 69,1 ml/satu, a volumen distribucije iznosio je 3,3 l.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data) The following serious side effects have been reported shortly after receiving Rienso: - life-threatening and fatal allergic reactions (anaphylactic/anaphylactoid hypersensitivity) - cardiovascular complications (affecting the heart and blood vessels) including heart attack,
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) Sljedeće ozbiljne nuspojave prijavljene su ubrzo nakon primanja lijeka Rienso: - po život opasne i smrtonosne alergijske reakcije (anafilaktička/anafilaktoidna preosjetljivost) - kardiovaskularne komplikacije (zahvaćaju srce i krvne žile) uključujući srčani udar,
English: However, caution should be exercised in interpreting serum iron levels in the 24 hours following administration of Rienso as laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in Rienso.
Croatian: Međutim, potreban je oprez kod tumačenja razina serumskog željeza u razdoblju od 24 sata nakon primjene lijeka Rienso, jer laboratorijski testovi mogu precijeniti serumsko željezo i željezo vezano za transferin time što mjere i željezo u lijeku Rienso.
English: Life-threatening Anaphylactic/Anaphylactoid reactions*
Croatian: po život opasne anafilaktičke/anafilaktoidne reakcije*
English: The aim of Rienso therapy is to replenish the body's iron stores.
Croatian: Cilj terapije lijekom Rienso jest obnova zaliha željeza u tijelu.
English: Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso.
Croatian: Bolesnike treba pažljivo nadzirati zbog znakova i simptoma reakcija preosjetljivosti, uključujući praćenje krvnog tlaka i pulsa, tijekom i najmanje 30 minuta nakon svake infuzije lijeka Rienso.
English: In rabbits administration of Rienso during organogenesis induced decreased foetal weights and external and/or soft tissue malformations (malrotated or flexed fore- and malrotated hindlimbs, internal hydrocephaly, absent brains, cleft palate and microglossia) at the high dose of 45.3 mg Fe/kg/day (HED of 14.6 mg Fe/kg/day), a dose which induced only minimal maternal toxicity.
Croatian: Kod kunića je primjena lijeka Rienso tijekom organogeneze inducirala smanjenje fetalne težine i vanjske malformacije i/ili malformacije mekih tkiva (malrotacija ili fleksija prednjih udova i malrotacija stražnjih, unutarnji hidrocefalus, odsutnost mozga, rascjep nepca i mikroglosija) kod visoke doze od 45,3 mg Fe/kg/dan (ekvivalentna doza kod ljudi od 14,6 mg Fe/kg/dan), koja je inducirala samo minimalnu toksičnost za majku.
English: No adverse effects on fertility or general reproductive performance were noted in rats given IV Rienso at doses up to 18 mg Fe/kg/day (Human Equivalent Dose of 2.9 mg Fe/kg/day).
Croatian: Nisu bili opaženi štetni učinci na plodnost ili opću reproduktivnu sposobnost štakora koji su intravenski primali Rienso u dozama do 18 mg Fe/kg/dan (ekvivalentna doza u ljudi je 2,9 mg Fe/kg/dan).
English: The MAH shall conduct a study to investigate the mechanism of hypersensitivity associated with the exposure to ferumoxytol, according to a protocol agreed by the CHMP.
Croatian: Nositelj odobrenja provest će ispitivanje kojim će proučiti mehanizam preosjetljivosti povezan s izlaganjem ferumoksitolu, sukladno planu ispitivanja dogovorenim s CHMP-om.
English: A second vial of the medicine should be administered as an infusion two to eight days later if indicated.
Croatian: Drugu bočicu lijeka treba primijeniti kao infuziju dva do osam dana kasnije, ako je to indicirano.
English: 5.3 Preclinical Safety Data
Croatian: 5.3 Neklinički podaci o sigurnosti primjene
English: Oral Iron n = 77
Croatian: Oralno željezo n = 77
English: As with all parenteral iron preparations the absorption of oral iron is reduced when administered concomitantly.
Croatian: Apsorpcija peroralno primijenjenog željeza, kao i svih preparata željeza primijenjenih parenteralno, smanjena je kad se primjenjuju istodobno.
English: Incompatibilities • Rienso must not be mixed with other medicinal products, with the exception of the infusion
Croatian: • Rienso se ne smije miješati s drugim lijekovima, osim niže navedenih tekućina za infuziju.
English: No data from clinical trials are available regarding overdose of Rienso in humans.
Croatian: Nema dostupnih podataka iz kliničkih ispitivanja o predoziranju lijekom Rienso kod ljudi.
English: For patients receiving two doses, the second 510 mg infusion is to be administered 2 to 8 days later as per Table1.
Croatian: Kod bolesnika koji primaju dvije doze, drugu infuziju doze od 510 mg treba primijeniti 2 do 8 dana kasnije prema tablici 1.
English: Rienso should be administered as an infusion in 50-250 ml of sterile 0.9% sodium chloride or sterile 5% glucose for at least 15 minutes (see sections 6.3 and 6.6).
Croatian: Rienso se mora primijeniti kao infuziju u 50-250 ml sterilne 0,9%-tne otopine natrijevog klorida ili sterilne 5%-tne otopine glukoze tijekom najmanje 15 minuta (vidjeti dio 6.3 i 6.6).
English: In the Rienso and oral iron groups, 36% and 43% of patients, respectively, were receiving ESAs at Baseline.
Croatian: U skupinama koje su primale Rienso i oralno željezo, 36% odnosno 43% bolesnika primalo je LSE na početku.
English: Rienso is not removed by haemodialysis.
Croatian: Rienso se ne uklanja hemodijalizom.
English: In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter.
Croatian: Osim toga, bolesnike treba postaviti u ležeći ili poluležeći položaj tijekom infuzije i najmanje 30 minuta nakon infuzije.
English: Hgb = haemoglobin; TSAT = transferrin saturation; SD = standard deviation
Croatian: SD, ng/ml) * p≤0,001 za glavni ishod djelotvornosti Hgb = hemoglobin; TSAT = zasićenost transferina; SD = standardna devijacija
English: Dosing should begin when blood pressure is stable and the patient has completed at least one hour of haemodialysis.
Croatian: Doza se može početi davati kad krvni tlak postane stabilan i kad je bolesnik proveo već najmanje jedan sat na hemodijalizi.
English: - if you have a history of medicine allergy or have experienced serious allergic (hypersensitive)
Croatian: - ako znate da imate alergiju na lijekove ili ako ste imali ozbiljne alergijske reakcije (reakcije preosjetljivosti) na druge injekcijske pripravke željeza.
English: Oral Iron n = 116
Croatian: Oralno željezo n = 116
English: The clearance (CL) was decreased with increased doses of Rienso.
Croatian: Klirens je bio smanjen kod većih doza lijeka Rienso.
English: Rienso should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
Croatian: Rienso se smije primjenjivati samo kada je osoblje izučeno za procjenu i zbrinjavanje anafilaktičkih reakcija odmah na raspolaganju, u okruženju u kojem je dostupna puna oprema za reanimaciju.
English: Administration of Rienso may transiently affect the diagnostic ability of MR imaging.
Croatian: Primjena lijeka Rienso može prolazno utjecati na dijagnostičke mogućnosti magnetske rezonancije (MR).
English: In the Rienso and oral iron groups, 42% and 44% of patients, respectively, were receiving erythropoiesis stimulating agents (ESAs) at Baseline.
Croatian: U skupinama koje su primale Rienso i peroralno željezo, 42% odnosno 44% bolesnika na početku je primalo lijekove za stimulaciju eritropoeze (LSE).
English: Hypotension may follow Rienso administration with or without accompanying signs of hypersensitivity (see section
Croatian: Hipotenzija može uslijediti nakon primjene lijeka Rienso sa ili bez popratnih znakova preosjetljivosti (vidjeti dio 4.8).
English: Excessive administration of Rienso may lead to accumulation of iron in storage sites potentially leading to haemosiderosis.
Croatian: Prekomjerna primjena lijeka Rienso može dovesti do nakupljanja željeza na mjestima pohrane željeza što potencijalno može dovesti do hemosideroze.
English: Rienso will be administered in an environment where any allergic event can receive appropriate and prompt treatment.
Croatian: Rienso će se davati u okolini gdje je odmah dostupno prikladno liječenje za slučaj bilo kakvog alergijskog događaja nakon primjene.
English: Common side effects (may affect up to 1 in 10 people): - bleeding, swelling, bruising, pain, rash, irritation or warmth at infusion/injection site
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba): - krvarenje, oticanje, stvaranje modrica, bol, osip, nadraženost ili toplina na mjestu davanja infuzije/injekcije
English: Baseline ferritin (mean ± SD, ng/ml)
Croatian: SD, ng/ml)
English: Study 1 Non-dialysis CKD
Croatian: Ispitivanje 1 KBB bez dijalize
English: 510 mg iron (1 vial)
Croatian: 510 mg željeza (1 bočica)
English: • No other intravenous dilution solutions and therapeutic agents should be used.
Croatian: • Ne smiju se upotrijebiti nikakve druge intravenske otopine za razrjeđivanje niti ljekovite tvari.
English: Ethanol and sodium content
Croatian: Sadržaj etanola i natrija
English: RARE (≥ 1/10,000 to
Croatian: RIJETKO (≥ 1/10 000 i
English: *Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting (see sections 4.3 and 4.4).
Croatian: *Nakon stavljanja lijeka Rienso u promet uočene su smrtonosne i po život opasne reakcije preosjetljivosti (vidjeti dijelove 4.3 i 4.4).
English: In Study 3, the mean age of patients was 60 years (range, 24 to 87); 43% were female; 34% were Caucasian, 59% were Black, and 7% were other races.
Croatian: U Ispitivanju 3, prosječna dob bolesnika bila je 60 godina (raspon, 24 do 87); žena je bilo 43%; bijelaca 34%, crnaca 59%, a 7% pripadalo je drugim rasama.
English: Oral Iron n = 76
Croatian: Oralno željezo n = 76
English: In Study 2, the mean age of patients was 65 years (range, 31 to 96); 61% were female; 58% were Caucasian, 35% were Black, and 7% were other races.
Croatian: U Ispitivanju 2, prosječna dob bolesnika bila je 65 godina (raspon, 31 do 96); žena je bilo 61%; bijelaca 58%, crnaca 35%, a 7% pripadalo je drugim rasama.
English: No other intravenous dilution solutions and therapeutic agents should be used.
Croatian: Ne smiju se upotrijebiti nikakve druge intravenske otopine za razrjeđivanje niti ljekovite tvari.
English: Study 2 Non-dialysis CKD
Croatian: Ispitivanje 2 KBB bez dijalize
English: In Study 1, the mean age of patients was 66 years (range, 23 to 95); 60% were female; 65% were Caucasian, 32% were Black, and 2% were other races.
Croatian: U Ispitivanju 1, prosječna dob bolesnika bila je 66 godina (raspon, 23 do 95); žena je bilo 60%; bijelaca 65%, crnaca 32%, a 2% je pripadalo drugim rasama.
English: In the 24 hours following administration of Rienso, laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in the Rienso complex.
Croatian: Tijekom 24 sata nakon primjene lijeka Rienso, laboratorijski testovi mogu pokazati veće vrijednosti serumskog željeza i željeza vezanog za transferin, jer mjere i željezo u Rienso kompleksu.
English: Overdose should be treated, if required, with an iron chelating agent.
Croatian: • Predoziranje se mora liječiti, ako je potrebno, sredstvima za keliranje željeza.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 30 mg of iron as ferumoxytol.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 ml otopine sadrži 30 mg željeza u obliku ferumoksitola.
English: Pulse absent Oxygen saturation decreased
Croatian: Pretrage snižena glukoza u krvi odsutnost pulsa snižena saturacija kisikom
English: Adverse reactions observed during clinical studies and post-marketing
Croatian: Tablica 2: Nuspojave opažene tijekom kliničkih ispitivanja i iskustva nakon stavljanja
English: MR images are interpretable earlier by readers aware of the recent administration of Rienso or by the use of T1- or proton density-weighted MR pulse sequences.
Croatian: Snimke magnetske rezonancije mogu se i ranije očitati ako su radiolozi koji ih očitavaju upoznati s nedavnom primjenom lijeka Rienso ili ako se primijeni pulsni slijed MR s primjenom T1 ili temeljen na gustoći protona.
English: In a pre-natal and post-natal development study in rats sexual maturation was delayed in male pups in the high dose of 60 mg Fe/kg/day (HED of 9.7 mg Fe/kg/day).
Croatian: U ispitivanju utjecaja na prenatalni i postnatalni razvoj štakora, kod muške mladunčadi došlo je do kašnjenja spolnog sazrijevanja kod visoke doze od 60 mg Fe/kg/dan (ekvivalentna doza kod ljudi od 9,7 mg Fe/kg/dan).
English: Rienso must not be given to patients if their haemoglobin is greater than 12 g/dl, serum Transferrin Saturation (TSAT) is greater than 50% or ferritin is greater than 800 ng/ml (see section 4.2).
Croatian: Rienso se ne smije dati bolesnicima čija je vrijednost hemoglobina veća od 12 g/dl, zasićenost serumskog transferina (TSAT) veća od 50% ili vrijednost feritina veća od 800 ng/ml (vidjeti dio 4.2).
English: Rienso should not be given to patients if their haemoglobin is greater than 12 g/dl, serum Transferrin Saturation (TSAT) is greater than 50% or Ferritin is greater than 800 ng/ml (see section 4.4).
Croatian: Rienso se ne smije davati bolesnicima čija je vrijednost hemoglobina veća od 12 g/dl, kada je zasićenje transferina u serumu (TSAT) veće od 50% ili feritin veći od 800 ng/ml (vidjeti dio 4.4).
English: In a prenatal and postnatal developmental study in rats adverse effects on sexual maturation and on the ability to produce a litter were noted in the F1-generation (see section 5.3).
Croatian: F1 generacije opaženi su štetni učinci na spolno sazrijevanje i sposobnost stvaranja potomstva (vidjeti dio 5.3).
English: Rienso-treated patients included hypotension, infusion site swelling, increased serum ferritin levels, chest pain, diarrhoea, dizziness, ecchymosis, pruritis, chronic renal failure and urticaria.
Croatian: Nuspojave koje su u kliničkim ispitivanjima dovele do prekida liječenja i nastale kod ≥ 2 bolesnika liječena lijekom Rienso uključivale su hipotenziju, oticanje na mjestu infuzije, povišene razine serumskog feritina, bol u prsištu, proljev, omaglicu, ekhimoze, pruritus, kronično zatajenje bubrega i urtikariju.
English: A second vial of the medicine should be administered as an infusion two to eight days later if indicated according to the SmPC.
Croatian: Drugu bočicu lijeka treba primijeniti kao infuziju dva do osam dana kasnije, ako je to indicirano prema Sažetku opisa svojstava lijeka.
English: congestive heart failure, palpitations, blood vessel dilation, changes in your pulse rate including weak/absent pulse, heart stops beating, heart and breathing stop, blue discolouration of skin and/or mucous membranes due to lack of oxygen in the blood (cyanosis) - fainting/loss of consciousness/unresponsiveness - sudden swelling up of skin or mucous membranes (angioedema), skin rash - wheezing (bronchospasm), cough, upper airway swelling, difficulty breathing (change to
Croatian: kongestivno zatajenje srca, lupanje srca, širenje krvnih žila, promjene brzine pulsa uključujući slab/odsutan puls, prestanak rada srca, prestanak rada srca i disanja, plava boja kože i/ili sluznica zbog nedostatka kisika u krvi (cijanoza) - nesvjestica/gubitak svijesti/nereagiranje na podražaje - iznenadno naticanje kože ili sluznica (angioedem), kožni osip - piskanje pri disanju (bronhospazam), kašalj, oticanje gornjih dišnih puteva, otežano disanje
English: Solution for infusion 1 vial
Croatian: Otopina za infuziju 1 bočica
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Rienso Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: In total 42 fatal cases have been reported cumulatively.
Croatian: Kumulativno su prijavljena ukupno 42 slučaja sa smrtnim ishodom, od kojih je 29 bilo povezano s reakcijama preosjetljivosti.
English: This includes the Baseline and mean change to Day 35 in haemoglobin (Hgb, g/dl), transferrin saturation (TSAT, %) and ferritin (ng/ml) as well as the proportion of subjects who were Hgb Responders at Day 35 (defined as proportion of subjects with an increase in Hgb of at least 1.0 g/dl) in each treatment group for Studies 1, 2, and 3.
Croatian: Glavni rezultati za djelotvornost 35 dana nakon kontrolirane faze tih ispitivanja prikazani su u tablici 3. Uključuju početnu vrijednost hemoglobina (Hgb, g/dl) i srednju vrijednost promjene hemoglobina do 35. dana, zasićenost transferina (TSAT, %), feritina (ng/ml) i udio ispitanika s odgovorom hemoglobina 35. dana (definiran kao udio ispitanika s povećanjem hemoglobina za najmanje 1,0 g/dl) u svakoj liječenoj skupini u ispitivanjima 1, 2, i 3.
English: - The active substance is iron as ferumoxytol 30 mg/ml.
Croatian: - Djelatna tvar je željezo u obliku ferumoksitola 30 mg/ml.
English: UNCOMMON (≥ 1/1,000 to
Croatian: MANJE ČESTO (≥ 1/1000 i
English: Overdose • Overdose should be treated, if required with an iron chelating agent.
Croatian: Predoziranje treba liječiti po potrebi primjenom sredstava za keliranje željeza.
English: Anticipated MR imaging studies should be conducted prior to the administration of Rienso.
Croatian: Predviđene pretrage magnetskom rezonancijom treba napraviti prije primjene lijeka Rienso.
English: The Cmax and time of maximum concentration (tmax) were 206 mcg/ml and 0.32 hr, respectively.
Croatian: Cmax iznosio je 206 mikrograma/ml, a vrijeme do postizanja maksimalne koncentracije (tmax) iznosilo je 0,32 sata.
English: Rienso must only be mixed with sterile sodium chloride 9 mg/ml (0.9%) or sterile 5% glucose up to a final concentration of 2-8 mg iron per ml.
Croatian: Rienso se smije miješati samo sa sterilnom otopinom natrijevog klorida od 9 mg/ml (0,9%) ili sterilnom 5%-tnom otopinom glukozom do konačne koncentracije od 2-8 mg željeza po ml.
English: Treatment Course
Croatian: Tijek liječenja
English: Your doctor will decide how much Rienso to give you based on your weight and blood test results.
Croatian: Liječnik će odlučiti koliko lijeka Rienso će Vam dati na temelju
English: You will be carefully observed during the infusion and for at least 30 minutes after each infusion by your doctor or nurse.
Croatian: Liječnik ili medicinska sestra će Vas pažljivo pratiti tijekom infuzije i najmanje 30 minuta nakon svake infuzije.
English: Marketing authorisation holder: Takeda Pharma A/S Dybendal Alle 10
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet: Takeda Pharma A/S
English: - 17 ml solution for infusion contains 510 mg of iron as ferumoxytol.
Croatian: - 17 ml otopine za infuziju sadrži 510 mg željeza u obliku ferumoksitola.
English: Following completion of the controlled phase of each of the Phase 3 trials, patients who were iron deficient and anaemic could be optionally retreated and receive two additional 510 mg intravenous injections of Rienso for a total cumulative dose of 2.04 g. Overall, 69 patients received a total cumulative dose of 2.04 g. Adverse reactions following this repeat Rienso dosing were similar in character and frequency to those observed following the first two intravenous injections.
Croatian: Nakon završetka kontrolirane faze u ta tri ispitivanja faze 3, bolesnici s manjkom željeza i anemijom mogli su se po izboru ponovno liječiti i primiti dvije dodatne intravenske injekcije od 510 mg lijeka Rienso do ukupne kumulativne doze od 2,04 g.
English: This medicinal product contains less than 23 mg sodium per 17 ml vial, i.e., is essentially “sodium free”.
Croatian: Ovaj lijek sadrži manje od 23 mg natrija po bočici od 17 ml, tj. zanemarive količine natrija.
English: • Rienso must only be mixed with sterile sodium chloride 9 mg/ml (0.9%) or sterile 5% glucose up to a final concentration of 2-8 mg iron per ml.
Croatian: • Rienso se smije miješati samo sa sterilnom otopinom natrijevog klorida od 9 mg/ml (0,9%) ili sterilnom 5%-tnom otopinom glukoze do konačne koncentracije od 2-8 mg željeza po ml.
English: Justification for not including Braille is accepted
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: Rare side effects (may affect up to 1 in 1,000 people): - burning, prickling, numbness or tingling sensation of skin - dehydration - upset stomach/indigestion - nose bleed - dry mouth - burning or tingling sensation of tongue/mouth - increased tearing - blurred vision - gout - abnormal blood tests (decreased glucose, elevated potassium, abnormal liver function, elevated type of white blood cell i.e. eosinophilia)
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba): - žarenje, trnci, utrnutost ili osjećaj trnaca po koži - dehidracija - nadražen želudac/probavne smetnje - krvarenje iz nosa - suha usta - osjećaj žarenja ili trnaca po jeziku/u ustima - pojačano suzenje - zamagljen vid - giht - poremećeni krvni nalazi (snižena glukoza, povišen kalij, poremećena funkcija jetre, povišena jedna vrsta bijelih krvnih stanica, tj. eozinofilija)
English: Rienso should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available.
Croatian: Rienso se smije primjenjivati samo kad su neposredno dostupni zdravstveni djelatnici osposobljeni u procjeni i zbrinjavanju anafilaktičkih reakcija.
English: No gender differences in Rienso PK parameters were observed.
Croatian: Nisu bile opažene razlike u farmakokinetičkim parametrima lijeka Rienso obzirom na spol.
English: - 1 ml solution for infusion contains 30 mg of iron as ferumoxytol.
Croatian: - 1 ml otopine za infuziju sadrži 30 mg željeza u obliku ferumoksitola.