FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema eozinofilija
English: For patients receiving two doses, the second 510 mg infusion is to be administered 2 to 8 days later as per Table1.
Slovenian: Bolniki, ki prejmejo dva odmerka, morajo drugo 510 mg intravensko infuzijo prejeti 2 do 8 dni kasneje, kot je navedeno v preglednici 1.
English: Rienso is a colloidal iron-carbohydrate complex.
Slovenian: Zdravilo Rienso je koloidni kompleks železa-ogljikovih hidratov.
English: P: +45 4677 1111 F: +45 4675 6640
Slovenian: Tel.: +45 4677 1111 Faks: +45 4675 6640
English: He or she will also monitor your blood test results to avoid iron accumulation.
Slovenian: Zdravnik bo nadziral tudi vaše izvide krvnih preiskav, da se železo ne začne kopičiti.
English: Rienso is a black to reddish-brown solution for infusion.
Slovenian: Zdravilo Rienso je črna do rdečkasto-rjava raztopina za infundiranje.
English: The clearance (CL) was decreased with increased doses of Rienso.
Slovenian: Očistek se je z večanjem odmerka zdravila Rienso manjšal.
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).
Slovenian: V študiji prenatalnega in postnatalnega razvoja pri podganah je bila spolna zrelost podgan pri podganjih samčkih pri visokih odmerkih 60 mg Fe/kg/dan (kar ustreza odmerku 9,7 mg Fe/kg/dan pri človeku) zakasnjena.
English: Talk to your doctor, pharmacist or nurse before receiving Rienso: - if you have a history of medicine allergy.
Slovenian: Preden boste prejeli zdravilo Rienso, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro: - če ste v preteklosti že imeli alergične reakcije.
English: A careful risk/benefit evaluation is therefore required before use during pregnancy and Rienso should not be used during pregnancy unless clearly necessary (see section 4.4).
Slovenian: Zdravila Rienso med nosečnostjo ne smete uporabljati, razen če je nujno potrebno (glejte poglavje 4.4).
English: A second vial of the medicine should be administered as an infusion two to eight days later if indicated.
Slovenian: Drugo vialo zdravila je treba dati v obliki infuzije dva do osem dni kasneje, če je to indicirano.
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.
Slovenian: Povprečna starost bolnikov v študiji 3 je bila 60 let (razpon 24 do 87); 43 % je bilo žensk, 34 % je bilo belcev, 59 % temnopoltih in 7 % so bile druge rase.
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.
Slovenian: • Bolnike je treba skrbno nadzirati glede pojava znakov in simptomov preobčutljivostnih reakcij, vključno s spremljanjem krvnega tlaka in srčnega utripa med vsakim infundiranjem zdravila Rienso in še najmanj 30 minut po njem.
English: Baseline Hgb (mean ± SD, g/dl)
Slovenian: Izhodiščni Hgb (srednja vrednost ± SD, g/dl)
English: Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11
Slovenian: Takeda Pharma A/S Tlf: +45 46 77 11 11
English: Magnetic Resonance (MR) Imaging
Slovenian: Slikanje z magnetno resonanco
English: This medicine contains small amounts of ethanol (alcohol), less than 100 mg per 17 ml vial.
Slovenian: To zdravilo vsebuje majhne količine etanola (alkohola), in sicer manj kot 100 mg na 1 vialo (17 ml).
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.
Slovenian: Povprečna starost bolnikov v študiji 2 je bila 65 let (razpon 31 do 96); 61 % je bilo žensk, 58 % je bilo belcev, 35 % temnopoltih in 7 % so bile druge rase.
English: Within this PSUR, a further literature review has been provided by the MAH identifying 9 relevant publications addressing ferumoxytol and MRI.
Slovenian: V tem poročilu PSUR je imetnik dovoljenja za promet z zdravilom navedel pregled dodatnih virov z 9 zadevnimi objavami o ferumoksitolu in MRI.
English: Administration of Rienso may transiently affect the diagnostic ability of MR imaging.
Slovenian: Dajanje zdravila Rienso lahko prehodno vpliva na diagnostično sposobnost slikanja z magnetno resonanco.
English: Solution for infusion 1 vial
Slovenian: raztopina za infundiranje 1 viala
English: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 17 ml vial.
Slovenian: To zdravilo vsebuje majhne količine etanola (alkohola), in sicer manj kot 100 mg na vialo (17 ml).
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.
Slovenian: Bolnike je treba skrbno nadzirati glede pojava znakov in simptomov preobčutljivostnih reakcij, vključno s spremljanjem krvnega tlaka in srčnega utripa med vsakim infundiranjem zdravila Rienso in še najmanj 30 minut po njem.
English: F: +45 4675 6640
Slovenian: Faks: +45 4675 6640
English: ≤ 50 kg Body Weight
Slovenian: hemoglobin telesna masa ≤ 50 kg telesna masa > 50 kg
English: Baseline ferritin (mean ± SD, ng/ml)
Slovenian: SD, ng/ml)
English: Treatment Course
Slovenian: Potek zdravljenja
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.
Slovenian: Povprečna starost bolnikov v študiji 1 je bila 66 let (razpon 23 do 95); 60 % je bilo žensk, 65 % je bilo belcev, 32 % temnopoltih in 2 % so bile druge rase.
English: No other intravenous dilution solutions and therapeutic agents should be used.
Slovenian: Uporabiti se ne sme nobene druge raztopine za redčenje ali drugega zdravila za intravensko uporabo.
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).
Slovenian: Zdravila Rienso se ne sme dajati bolnikom, če je njihov hemoglobin večji kot 12 g/dl, nasičenost transferina v serumu (TSAT) večja kot 50 % ali ki imajo vrednost feritina višjo od 800 ng/ml (glejte poglavje 4.2).
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).
Slovenian: Zdravilo Rienso je treba aplicirati v obliki infuzije v 50-250 ml sterilne 0,9-odstotne raztopine natrijevega klorida ali sterilne 5-odstotne raztopine glukoze najmanj 15 minut (glejte poglavji 6.3 in
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.
Slovenian: Bolniki na hemodializi lahko zdravilo Rienso prejmejo, ko se krvni tlak stabilizira in je bil bolnik vsaj eno uro na hemodializi.
English: Rienso-treated patients included hypotension, infusion site swelling, increased serum ferritin levels, chest pain, diarrhoea, dizziness, ecchymosis, pruritis, chronic renal failure and urticaria.
Slovenian: V kliničnih preskušanjih so neželeni učinki, ki so povzročili prekinitev zdravljenja in so se pojavili pri ≥ 2 bolnikih, zdravljenih z zdravilom Rienso, vključevali hipotenzijo, oteklino na mesto infundiranja, povečane ravni feritina v serumu, bolečino v prsih, drisko, omotico, ekhimozo, pruritis, kronično ledvično odpoved in urtikarijo.
English: In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter.
Slovenian: Poleg tega morajo biti bolniki med infundiranjem in še najmanj 30 minut po njem nameščeni v ležeč ali polležeč položaj.
English: No adverse effects on fertility or general reproductive performance were noted in adult rats (see Section 5.3).
Slovenian: Pri odraslih podganah niso opazili neželenih učinkov na plodnost ali splošno sposobnost razmnoževanja (glejte poglavje 5.3).
English: Justification for not including Braille is accepted
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna
English: Common side effects (may affect up to 1 in 10 people): - bleeding, swelling, bruising, pain, rash, irritation or warmth at infusion/injection site
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): - krvavitev, oteklina, modrice, bolečina, izpuščaj, draženje ali občutek toplote na mestu infundiranja/injiciranja.
English: You will be carefully observed during the infusion and for at least 30 minutes after each infusion by your doctor or nurse.
Slovenian: Med vsakim infundiranjem in še najmanj 30 minut po njem vas bosta zdravnik ali medicinska sestra skrbno nadzirala.
English: • Hypersensitivity to the active substance, to Rienso or any of its excipients listed in section 6.1
Slovenian: • preobčutljivosti za zdravilno učinkovino, zdravilo Rienso ali katero koli pomožno snov,
English: SYSTEM ORGAN CLASS
Slovenian: ORGANSKI SISTEMI
English: - throat irritation, throat tightness, lip swelling, tongue swelling - injection site discolouration, injection site itching and discolouration
Slovenian: - draženje grla, stiskanje v grlu, oteklost ustnic, oteklost jezika - obarvanje mesta injiciranja, srbenje in obarvanje mesta injiciranja
English: Injection site discolouration Injection site pruritus
Slovenian: obarvanje mesta injiciranja pruritus na mestu injiciranja
English: What Rienso contains
Slovenian: Kaj vsebuje zdravilo Rienso
English: Hypotension may follow Rienso administration with or without accompanying signs of hypersensitivity (see section
Slovenian: Hipotenzija se lahko pojavi po dajanju zdravila Rienso z znaki preobčutljivosti ali brez njih (glejte poglavje 4.8).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 30 mg of iron as ferumoxytol.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 30 mg železa v obliki ferumoksitola.
English: COMMON (≥ 1/100 to
Slovenian: POGOSTI (≥1/100 do <1/10)
English: Overdose should be treated, if required, with an iron chelating agent.
Slovenian: Preveliko odmerjanje po potrebi zdravite s sredstvom za keliranje železa.
English: In the Rienso and oral iron groups, 42% and 44% of patients, respectively, were receiving erythropoiesis stimulating agents (ESAs) at Baseline.
Slovenian: V skupini z zdravilom Rienso je eritropoezo stimulirajoča zdravila (ESAs - erythropoiesis stimulating agents) ob izhodišču prejemalo 42 % in v skupini s peroralnim železom 44 % bolnikov.
English: Rienso is not removed by haemodialysis.
Slovenian: Zdravila Rienso s hemodializo ni mogoče odstraniti.
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).
Slovenian: Zdravila Rienso se ne sme uporabiti pri bolnikih, ki imajo raven hemoglobina več kot 12 g/dl, pri katerih je nasičenost transferina v serumu (TSAT) večja kot 50 % ali ki imajo vrednost feritina višjo od 800 ng/ml (glejte poglavje 4.4).
English: The MAH shall conduct a PASS to further characterise the safety concerns on the hypersensitivity reactions.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora izvesti študijo o varnosti zdravila po pridobitvi dovoljenja za promet (PASS), s katero bo natančneje opredelil varnostne zadržke v zvezi s preobčutljivostnimi reakcijami.
English: Baseline at Day 35 (mean ± SD, g/dl)
Slovenian: Sprememba Hgb 35. dan od izhodišča (srednja vrednost ± SD, g/dl)
English: - The active substance is iron as ferumoxytol 30 mg/ml.
Slovenian: - Zdravilna učinkovina je železo v obliki ferumoksitola 30 mg/ml.
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.
Slovenian: Zdravilo Rienso se lahko meša le s sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %) ali s sterilno raztopino 5 % glukoze do končne koncentracije 2-8 mg železa na ml.
English: • Administer Rienso as an infusion as follows: o 510 mg (one vial) diluted in 50-250 ml of sterile 0.9% sodium chloride or sterile 5% glucose, administered for at least 15 minutes (concentration of 2-8 mg iron per ml).
Slovenian: • Zdravilo Rienso dajte v obliki infuzije, kot sledi: o 510 mg (ena viala), razredčena v 50-250 ml sterilne 0,9-odstotne raztopine natrijevega klorida ali sterilne 5-odstotne raztopine glukoze, ki se daje najmanj 15 minut (v koncentraciji 2-8 mg železa na ml).
English: Two of these reports were included by the MAH as late breaking information into this PSUR.
Slovenian: Dve poročili je imetnik dovoljenja za promet z zdravilom vključil v ta PSUR kot najnovejši informaciji.
English: Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product.
Slovenian: Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji zdravila.
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.
Slovenian: • Zdravilo Rienso se lahko meša le s sterilno raztopino natrijevega klorida 9 mg/ml (0,9 %) ali s sterilno raztopino 5 % glukoze do končne koncentracije 2-8 mg železa na ml.
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)
Slovenian: Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): - žarenje, ščemenje, otrplost ali zbadanje kože - dehidracija - vznemirjen želodec/prebavne motnje - krvavitev iz nosu - suha usta - žarenje ali ščemenje jezika/ust - povečano solzenje - zamegljen vid - protin - nenormalni izvidi krvnih preiskav (zmanjšanje glukoze, zvišanje kalija, nenormalno delovanje jeter, povečana raven vrste belih krvnih celic, tj. eozinofilija).
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.
Slovenian: Zdravilo Rienso se lahko aplicira le, če je v primeru pojava anafilaktične reakcije nemudoma na voljo osebje, usposobljeno za prepoznavanje in ukrepanje v primeru pojava anafilaktične reakcije, in prostor z ustrezno opremo za oživljanje.
English: Some people may feel dizzy, confused or lightheaded after receiving treatment.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekatere osebe so lahko po prejemu zdravila omotične, zmedene ali imajo vrtoglavico.
English: In the Rienso and oral iron groups, 36% and 43% of patients, respectively, were receiving ESAs at Baseline.
Slovenian: V skupini z zdravilom Rienso je eritropoezo stimulirajoča zdravila ob izhodišču prejemalo 36 % in v skupini s peroralnim železom 43% bolnikov.
English: Rienso 30 mg/ml solution for infusion Iron as ferumoxytol
Slovenian: Rienso 30 mg/ml raztopina za infundiranje železo v obliki ferumoksitola
English: Your doctor will decide how much Rienso to give you based on your weight and blood test results.
Slovenian: Vaš zdravnik se bo na podlagi vaše telesne mase in na podlagi izvidov krvnih preiskav odločil, koliko zdravila Rienso boste prejeli.
English: - 17 ml solution for infusion contains 510 mg of iron as ferumoxytol.
Slovenian: - 17 ml raztopine za infundiranje vsebuje 510 mg železa v obliki ferumoksitola.
English: TSAT change from
Slovenian: Sprememba TSAT
English: The most frequently reported adverse reactions were gastrointestinal symptoms (diarrhoea, constipation, nausea and vomiting), headache, dizziness and hypotension, all occurring in less than 2.5% of patients.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so bili gastrointestinalni simptomi (driska, zaprtje, navzea in bruhanje), glavobol, omotica in hipotenzija.
English: - 1 ml solution for infusion contains 30 mg of iron as ferumoxytol.
Slovenian: - 1 ml raztopine za infundiranje vsebuje 30 mg železa v obliki ferumoksitola.
English: Marketing authorisation holder: Takeda Pharma A/S Dybendal Alle 10
Slovenian: Imetnik dovoljenja za promet z zdravilom: Takeda Pharma A/S
English: A second vial of the medicine should be administered as an infusion two to eight days later if indicated according to the SmPC.
Slovenian: Drugo vialo zdravila je treba dati v obliki infuzije dva do osem dni kasneje, če je to indicirano, v skladu s Povzetkom glavnih značilnosti zdravila.
English: Each vial of 17 ml solution contains 510 mg of iron as ferumoxytol.
Slovenian: Ena viala s 17 ml raztopine vsebuje 510 mg železa v obliki ferumoksitola.
English: This medicine contains less than 23 mg sodium per 17 ml vial, i.e., it is essentially “sodium free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo (17 ml), kar v bistvu pomeni “brez natrija”.
English: Read the package leaflet before use.
Slovenian: 10 vial samo za intravensko uporabo Pred uporabo preberite priloženo navodilo!
English: • Shelf life after first opening and after dilution for infusion: Chemical and physical in-use stability has been demonstrated for 96 hours at 25 °C
Slovenian: Dokazano je bilo, da je raztopina, pripravljena za uporabo, kemijsko in fizikalno stabilna 96 ur
English: In a lactation study in rats, there was minimal excretion of Rienso or Rienso-derived radioactivity into milk following single IV administration of approximately 100 mg Fe/kg (HED of 16.1 mg Fe/kg, approximately 2 times the recommended 510 mg human dose on a mg/m basis) of either the unlabelled,
Slovenian: odmerku v višini približno 100 mg Fe/kg (kar ustreza odmerku 16,1 mg Fe/kg pri človeku, kar je približno 2-kratni priporočeni odmerek 510 mg pri človeku na osnovi mg/m
English: - The other ingredients are mannitol, Polyglucose-sorbitol carboxymethylether (PSC), Sodium hydroxide (for pH adjustment, Hydrochloric acid (for pH adjustment) and water for injections.
Slovenian: Pomožne snovi: poliglukoza-sorbitolkarboksimetileter manitol voda za injekcije natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
English: In female pups of the mid and high dose groups of 30 mg Fe/kg/day and 60 mg Fe/kg/day respectively (HED of 4.8 mg Fe/kg/day and
Slovenian: Pri podganjih samičkah skupine s srednje velikimi - 30 mg Fe/kg/dan in velikimi odmerki 60 mg Fe/kg/dan (kar ustreza odmerku 4,8 mg Fe/kg/dan oz. 9,7 mg Fe/kg/dan pri človeku) je bila spolna zrelost zakasnjena, pri nekaterih samičkah pa so opazili prekinitev estrusnega cikla.
English: How to store Rienso
Slovenian: Dajanje zdravila Rienso
English: Study 2 Non-dialysis CKD
Slovenian: Študija 2 bolniki s kronično ledvično boleznijo, ki niso na dializi
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov motnje delovanja jeter
English: Rienso 30 mg/ml solution for infusion.
Slovenian: IME ZDRAVILA Rienso 30 mg/ml raztopina za infundiranje
English: Skin & subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja angioedem
English: NAME OF THE MEDICINAL PRODUCT Rienso 30 mg/ml solution for infusion Iron as ferumoxytol
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Rienso 30 mg/ml infuzija železo v obliki ferumoksitola samo za intravensko uporabo
English: - discoloured stools - changes in taste - increased or decreased appetite - muscle/joint pain, weakness or stiffness, muscle spasms - headache - chest pain/discomfort - back pain - changes in blood test results (e.g. iron parameters) - allergic reaction including severe allergic reaction (see paragraph "serious side effects")
Slovenian: - mrzlica - visok krvni tlak (nenadno zvišanje krvnega tlaka) - kožni izpuščaj, srbenje, temnenje predelov kože ali nohtov, modrice, koprivnica - pekoč občutek v koži - težko dihanje - driska - zaprtost - bolečina/nelagodje v želodcu - napihnjenost želodca ali napenjanje - slabost, bruhanje - obarvano blato - spremenjen okus - povečan ali zmanjšan apetit - bolečina, šibkost ali togost mišic/sklepov, mišični krči - glavobol - bolečina/nelagodje v prsih - bolečina v hrbtu - spremembe v izvidih krvnih preiskav (npr. parametri za železo) - alergijske reakcije, vključno s hudo alergijsko reakcijo (glejte poglavje "resni neželeni učinki")
English: 1 ml contains 30 mg of iron.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml vsebuje 30 mg železa
English: All patients were receiving ESAs at Baseline.
Slovenian: Vsi bolniki so ob izhodišču prejemali eritropoezo stimulirajoča zdravila.
English: Pulse absent Oxygen saturation decreased
Slovenian: Preiskave povečanje feritina v serumu zmanjšanje glukoze v krvi odsoten utrip zmanjšana nasičenost s kisikom
English: Baseline TSAT (mean ± SD, %)
Slovenian: Izhodiščna TSAT (srednja vrednost ±
English: Dizziness Dysgeusia Headache Somnolence Burning sensation
Slovenian: Bolezni živčevja parestezija sinkopa neodzivnost izguba zavesti
English: Rienso Administration
Slovenian: Shranjevanje zdravila Rienso
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
Slovenian: Neželeni učinki neznane pogostnosti (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) Kmalu po prejemu zdravila Rienso so poročali o naslednjih resnih neželenih učinkih: - življenje ogrožajoče in smrtne alergijske reakcije (anafilaktična/anafilaktoidna preobčutljivost) - zapleti srca in ožilja (prizadenejo srce in ožilje), vključno s srčnim infarktom, kongestivno srčno popuščanje, palpitacije (občutek razbijanja srca), razširitev krvnih žil, spremembe hitrosti utripa, vključno s šibkim/odsotnim utripom, prenehanje utripanja srca, ustavitev srca in dihanja, modro obarvanje kože in/ali sluznic zaradi pomanjkanja kisika v krvi (cianoza) - omedlevanje/izguba zavesti/neodzivnost - nenadno otekanje kože ali sluznic (angioedem), kožni izpuščaj - sopenje (bronhospazem), kašelj, oteklost zgornjih dihal, težave z dihanjem (spremenjena
English: Overdose • Overdose should be treated, if required with an iron chelating agent.
Slovenian: Preveliko odmerjanje • Preveliko odmerjanje po potrebi zdravite s sredstvom za keliranje železa.
English: Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting.
Slovenian: V obdobju trženja zdravila Rienso so opazili smrtne in življenjsko nevarne preobčutljivostne reakcije.
English: Hyperventilation Hypoxia
Slovenian: Žilne bolezni vazodilatacija
English: Name and address of the manufacturer responsible for batch release Takeda Italia S.p.A.
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: In 5 out of these 6 cases, ferumoxytol was administered via IV injection (either quick or slow IV push), for the remaining case the method of administration is unknown.
Slovenian: V 5 od teh 6 primerov so ferumoksitol dajali v obliki i.v.
English: Table 1: Recommended Dosing Table for Rienso Administration Total Amount of Rienso to Administer mg of Iron (Number of vials)
Slovenian: Preglednica 1: Preglednica priporočenega odmerjanja zdravila Rienso