natgillin/translations-raw huggingface dataset:
Parenteral iron should be used with caution in cases of immunologic disease or acute or chronic infection. 
Pri parenteralnem dajanju železa je potrebna previdnost v primerih imunološke bolezni oz. akutne ali kronične okužbe.
What you need to know before you receive Rienso 
Kaj morate vedeti, preden boste dobili zdravilo Rienso
Rienso is supplied in glass vials containing 17 ml. 
Zdravilo Rienso je na voljo v steklenih vialah, ki vsebujejo 17 ml.
Chemical and physical in-use stability has been demonstrated for 96 hours at 25 °C. 
Dokazano je bilo, da je raztopina, pripravljena za uporabo, kemijsko in fizikalno stabilna 96 ur pri temperaturi 25 °C.
Volume of distribution (Vd) was consistent with plasma volume, and the mean maximum observed plasma concentration (Cmax) and terminal half-life (t1/2) values increased with dose. 
Volumen porazdelitve (Vd) se je ujemal s plazemskim volumnom, povprečne največje vrednosti koncentracije v plazmi (Cmax) in končnega razpolovnega časa (t1/2), ki so jih opazili, pa so se z odmerkom večale.
The study will also have to be reflected in the updated RMP submission. 
Študija se bo morala odražati tudi v posodobljenem načrtu za obvladovanje tveganja (RMP).
The treatment you will receive can be 1 or 2 vials of Rienso (510 mg each) by infusion and each dose will be infused into a vein. 
Zdravljenje, ki ga boste prejeli, sta lahko 1 ali 2 viali zdravila Rienso (510 mg vsaka) z infuzijo, pri čemer se vsak odmerek infundira v veno.
Cumulatively, since the granting of the marketing authorisation up to the data lockpoint (DLP) of the current PSUR, a total of 527 reported post-marketing cases of hypersensitivity reactions of which more than 50 % were serious including life threatening allergic reactions (264 serious, 263 non-serious). 
Kumulativno so od pridobitve dovoljenja za promet z zdravilom do datum zaključka zbiranja podatkov trenutnega PSUR poročali o skupaj 527 primerih preobčutljivnostih iz obdobja trženja zdravila, med katerimi je bilo več kot 50 % resnih, vključno z življenjsko nevarnimi alergijskimi reakcijami (264 resnih, 263 primerov, ki niso bili resni).
Please see the iron overload section 4.4 and for dosing guidance, see section 4.2. 
Za preobremenitev z železom glejte poglavje 4.4 in za smernice glede odmerjanja poglavje 4.2.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 510 mg/17 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 510 mg / 17 ml
Rienso may have a minor influence on the ability to drive and use machines. 
Zdravilo Rienso ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
Rienso should be administered as an intravenous infusion into a new or existing venous access site. 
Zdravilo Rienso je treba dati v obliki intravenske infuzije v nov ali obstoječ venski dostop.
Each 510 mg dose is administered as an intravenous infusion for at least 15 minutes. 
Odmerek 510 mg se da v obliki intravenske infuzije, ki traja najmanj 15 minut.
Rienso exhibited dose-dependent, capacity-limited elimination from plasma with a half life of approximately 16 hours in humans. 
Zdravilo Rienso je pokazalo od odmerka odvisno izločanje iz plazme z omejeno stopnjo z razpolovnim časom približno 16 ur, pri ljudeh.
Overdose can cause accumulation of iron in your body. 
Prevelik odmerek lahko povzroči kopičenje železa v telesu.
A decision must be made whether to discontinue breast-feeding or to discontinue Rienso therapy, taking into account the benefit of breast-feeding for the child and the benefit of the therapy for the mother. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Rienso, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
reactions to other injectable iron preparations. 
reakcijo na druga zdravila za injiciranje, ki vsebujejo železo.
As seen from clinical data there is no evidence that these effects seen in female rats are relevant for humans. 
Na podlagi kliničnih podatkov ni dokazov, da bi imeli opisani učinki pri podganjih samicah povezavo s človekom.
Interference with Magnetic Resonance Imaging (MRI) No spontaneous post-marketing reports of MRI interference have been received to date. 
Vpliv na magnetnoresonančno slikanje (MRI- Magnetic Resonance Imaging) Do danes ni bilo prejeto nobeno spontano poročilo iz obdobja trženja zdravila o vplivu na MRI.
Iron Overload 
Preobremenitev z železom
If you receive more Rienso than you should 
Če ste prejeli večji odmerek zdravila Rienso, kot bi smeli
In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. 
Bolnikom z jetrno disfunkcijo se lahko železo parenteralno daje samo po skrbni presoji razmerja med koristmi in tveganji.
• Anaemia not caused by iron deficiency 
• anemiji, ki ni posledica pomanjkanja železa.
The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy (see section 4.3). 
Tveganje je večje pri bolnikih z znanimi alergijami, vključno z alergijami na zdravila, in pri bolnikih s hudo astmo, ekcemom ali drugo atopično alergijo v anamnezi (glejte poglavje 4.3).
Limited clinical study data is available regarding re-treatment with Rienso and no clinical study data is available for repeated long term use. 
V zvezi s ponovnim zdravljenjem z zdravilom Rienso so razpoložljivi omejeni podatki iz kliničnih študij, podatkov iz kliničnih študij za večkratno dolgotrajno uporabo ni na voljo.
For patients receiving two vials, the second one will be infused two to eight days after the first infusion. 
Bolnikom, ki bodo prejeli dve viali, se druga infundira dva ali osem dni po prvi infuziji.
In a placebo-controlled, cross-over trial, 713 patients with CKD received a single 510 mg dose of Rienso and placebo. 
V križnem, s placebom kontroliranem preskušanju, je 713 bolnikov s kronično ledvično boleznijo prejelo en odmerek 510 mg zdravila Rienso in placebo.
Available pharmacokinetic data in animals have shown excretion of Rienso in milk (see section 5.3). 
Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje zdravila Rienso v mleko (glejte poglavje 5.3).
Mean haemoglobin increased (0.5-0.9 g/dl) post-treatment and stabilised in the range of 11-11.7 g/dl over the 10 month post-dose period; no new safety signals were identified with repeat dosing. 
Povprečni hemoglobin se je po zdravljenju povečal (0,5-0,9 g/dl) in stabiliziral v razponu med 11-11,7 g/dl v 10 mesecih po odmerjanju; novih varnostnih signalov po ponovnem odmerjanju niso opazili.
Periodic monitoring of laboratory parameters of iron storage, such as serum ferritin and transferrin saturation, enables recognition of iron accumulation. 
Obdobno spremljanje laboratorijskih parametrov zalog železa, kot so feritin v serumu in nasičenost transferina, omogoča prepoznavanje kopičenja železa.
When there is insufficient iron in the body, haemoglobin cannot be formed, resulting in anaemia (low levels of haemoglobin). 
Zaradi pomankjanja železa v telesu ne more nastajati hemoglobin, kar ima za posledico slabokrvnost (nizka raven hemoglobina).
SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATIONS 
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA PRIPOROČENO SPREMEMBO POGOJEV
Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution. 
Na voljo morajo biti ustrezni pripomočki in oprema za kardiopulmonalno oživljanje in za ravnanje z akutnimi anafilaktičnimi/anafilaktoidnimi reakcijami, vključno z injekcijo raztopine adrenalina v razmerju 1:1.000.
On the basis of the scientific conclusions for Rienso, the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing the active substance ferumoxytol is favourable subject to the proposed changes to the product information. 
Na podlagi znanstvenih zaključkov za zdravilo Rienso odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravila, ki vsebuje zdravilno učinkovino ferumoksitol, ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
Children and adolescents Rienso should not be given to children and adolescents under 18 years old. 
Otroci in mladostniki Zdravilo Rienso se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Rienso will be administered in an environment where any allergic event can receive appropriate and prompt treatment. 
Zdravilo Rienso boste prejeli v okolju, kjer je ob alergijski reakciji na voljo ustrezno in takojšnje zdravljenje.
Baseline at Day 35 (mean ± SD, ng/ml) * p≤0.001 for main efficacy endpoint 
SD, ng/ml) * p ≤ 0,001 za glavni cilj učinkovitosti
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. 
Po zaključku kontrolirane faze vsakega od preskušanj 3. faze so imeli bolniki s pomanjkanjem železa in anemijo možnost ponovnega zdravljenja in prejetja dveh dodatnih 510 mg intravenskih injekcij zdravila Rienso do skupnega kumulativnega odmerka 2,04 g. Na splošno je 69 bolnikov prejelo skupni kumulativni odmerek 2,04 g. Neželeni učinki po tej ponovni uporabi odmerkov zdravila Rienso so bili po značaju in pogostnosti podobni učinkom, ki so jih opazili po prvih dveh intravenskih injekcijah.
In addition, patients should be placed in a reclining or semi-reclining position during infusion and for at least 30 minutes thereafter (see section 4.4). 
Poleg tega morajo biti bolniki med infundiranjem in še najmanj 30 minut po njem nameščeni v ležeč ali polležeč položaj (glejte poglavje 4.4).
The shell isolates the bioactive iron from plasma components until the iron-carbohydrate complex enter reticuloendothelial system macrophages of the liver, spleen and bone marrow. 
Ovojnica izolira biološko aktivno železo pred sestavinami plazme, dokler kompleks železo-ogljikov hidrat ne vstopi v makrofage retikuloendotelijskega sistema jeter, vranice in kostnega mozga.
One patient had a prior history of drug allergy. 
En bolnik je imel alergijo na zdravilo v anamnezi.
What is in this leaflet What Rienso is and what it is used for What you need to know before you receive Rienso 
Kaj je zdravilo Rienso in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo Rienso
Administration should be performed as follows: 
Dajanje se opravi kot sledi:
Therefore, in view of available data regarding hypersensitivity reactions and interference with Magnetic Resonance Imaging (MRI), the PRAC considered that changes to the product information were warranted. 
V luči razpoložljivih podatkov v zvezi s preobčutljivostnimi reakcijami in vplivom na magnetnoresonančno slikanje (MRI) je zato odbor PRAC presodil, da so spremembe informacij o zdravilu utemeljene.
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. 
Imetnik dovoljenja za promet z zdravilom mora izvesti študijo za preučitev mehanizma preobčutljivosti, povezanega z izpostavljenostjo ferumoksitolu, v skladu s protokolom, dogovorjenim z odborom CHMP.
The ability to produce a litter (reproductive competence) was reduced in high dose males and in mid and high dose females, irrespective of whether F1 males were mated with F1 females or F1 males were mated with naive females and vice versa. 
Sposobnost imeti leglo (reproduktivna sposobnost) je bila pri samčkih, ki so dobivali velike odmerke in pri samičkah, ki so dobivale srednje velike in velike odmerke, zmanjšana, ne glede na to, ali so samčke F1 parili s samičkami F1 ali pa so samčke F1 parili z nezdravljenimi samičkami in obratno.
- if you are scheduled for magnetic resonance imaging (an MRI scan), as this medicine may interfere with the interpretation of the scan. 
- če imate načrtovano slikanje z magnetno resonanco (MR-slikanje), saj lahko to zdravilo vpliva na razlago izsledkov slikanja.
Rienso has not been tested in pregnant women. 
Zdravilo Rienso ni bilo preskušeno pri nosečnicah.
510 mg iron/17 ml 
510 mg železa / 17 ml
Available in packs sizes of 1, 2, 6 or 10 vials. 
Na voljo je v velikostih pakiranja po 1, 2, 6 ali 10 vial.
Considering the cumulative number of reported cases of hypersensitivity reactions (serious, nonserious) including 35 fatal cases, the PRAC considered new additional risk minimisation measures in addition to the ones already implemented as part of the previous PSUR, and recommended that a warning on the severity of the outcome of hypersensitivity reactions in patients over 65 or with comorbidities should be added in section 4.4 of the SmPC. 
Ob upoštevanju kumulativnega števila poročanih primerov preobčutljivostnih reakcij (resnih, reakcij, ki niso bile resne), vključno s 35 smrtnimi primeri, je odbor PRAC presodil, da so potrebni novi dodatni ukrepi za zmanjšanje tveganja poleg že obstoječih, uvedenih v prejšnjem PSUR, in priporočal, da se v poglavje 4.4 povzetka glavnih značilnosti zdravila doda opozorilo o resnosti izida preobčutljivostnih reakcij pri bolnikih, starih več kot 65 let, s sočasnimi obolenji.
There are no adequate and well-controlled trials of Rienso in pregnant women. 
Ustreznih in dobro kontroliranih preskušanj o uporabi zdravila Rienso pri nosečnicah ni na voljo.
- if your anaemia is not caused by iron deficiency. 
- če vzrok vaše slabokrvnosti ni pomanjkanje železa.
Rienso is not recommended in women of childbearing potential not using adequate contraception. 
Uporabe zdravila Rienso se ne priporoča pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Cumulatively 21 cases of hypersensitivity (8 serious, 13 non-serious) have been reported during clinical trials. 
Med kliničnimi preskušanji so kumulativno poročali o 21 primerih preobčutljivosti (8 resnih, 13 primerih, ki niso bili resni).
Your doctor or nurse will administer Rienso by infusion into a vein. 
Zdravnik ali medicinska sestra vam bosta dala zdravilo Rienso v obliki infuzije v veno.
What Rienso is and what it is used for 
Kaj je zdravilo Rienso in za kaj ga uporabljamo
Other medicines and Rienso 
Druga zdravila in zdravilo Rienso
It is used to treat iron deficiency anaemia resulting from a lack of stored iron, in adult patients with reduced kidney function. 
Uporablja se za zdravljenje slabokrvnosti zaradi pomanjkanja železa, ki je posledica pomanjkanja zalog železa pri odraslih bolnikih z zmanjšanim delovanjem ledvic.
C-labelled product to lactating rats 10-11 days post-parturition, which peaked at 8 to 24 hours post-administration. 
C označenega zdravila, ki so ga dali podganam v obdobju laktacije 10-11 dni po kotitvi, z najvišjo vrednostjo 8 do 24 ur po dajanju.
The vials should be inspected visually to ensure the absence of particulate matter and damage prior to administration. 
Pred uporabo je treba vialo vizualno pregledati in zagotoviti odsotnost delcev ali poškodb.
In clinical trials involving 1562 subjects with CKD, adverse reactions were seen in 7.9% of patients who received Rienso, of which 0.2% were considered serious. 
V kliničnih preskušanjih, v katerih je sodelovalo 1.562 oseb s kronično ledvično boleznijo, so neželene učinke opazili pri 7,9 % bolnikov, ki so prejeli zdravilo Rienso, med katerimi jih je bilo 0,2 % obravnavanih kot resnih.
Studies 1 and 2 enrolled patients with non-dialysis dependent CKD and Study 3 enrolled patients who were undergoing haemodialysis. 
V študijo 1 in 2 so bili vključeni bolniki s kronično ledvično boleznijo, ki niso bili odvisni od dialize, v študijo 3 pa so bili vključeni bolniki, ki so bili na hemodializi.
Therefore the MAH proposed as part of this PSUR to amend the current warning in section 4.4 of the SmPC to reflect that interference with MRI can occur up to 6 months after administration of ferumoxytoll which was agreed by the PRAC. 
Zato imetnik dovoljenja za promet z zdravilom predlaga, da se kot del tega PSUR spremeni trenutno opozorilo v poglavju 4.4 povzetka glavnih značilnosti zdravila z navedbo, da se lahko vpliv na MRI pojavi do 6 mesecev po dajanju ferumoksitola, s čimer se je odbor PRAC strinjal.
Black to reddish brown solution Osmolality: 270-330 mosm/kg pH: 6.5 to 8.0 
raztopina za infundiranje črna do rdečkasto-rjava raztopina osmolalnost: 270-330 mosm/kg pH: 6,5 do 8,0
Summary of Efficacy Endpoints at Day 35 (Intent to Treat Population) 
Preglednica 3: Povzetek ciljev učinkovitosti 35. dan (vsi vključeni bolniki)
If you are on haemodialysis, you may receive Rienso via infusion over 15 minutes during a dialysis session. 
Če ste na hemodializi, boste morda prejeli zdravilo Rienso prek infuzije, ki traja 15 minut, med dializo.
Tell your doctor or nurse immediately if you experience any of the following signs and symptoms indicating serious side effects during or shortly after treatment: rash, itching, (sudden) dizziness, light-headedness, (increasing) swelling, difficulty breathing, wheezing or any other problems you may have. 
Svojemu zdravniku ali medicinski sestri takoj povejte, če med prejemanjem zdravila ali kmalu po prejemu zdravila opazite katere od spodaj navedenih znakov in simptomov, ki kažejo na resne neželene učinke: izpuščaj, srbenje, (nenadna) omotica, vrtoglavost, (povečano) otekanje, oteženo dihanje, sopenje ali kakršne koli druge težave, ki jih opazite.
Rienso contains ethanol and sodium 
Zdravilo Rienso vsebuje etanol in natrij
After the DLP of the present PSUR, 6 additional fatal cases of hypersensitivity reactions with ferumoxytol have been reported. 
Po datum zaključka zbiranja podatkov za sedanji PSUR so poročali o 6 dodatnih smrtnih primerih zaradi preobčutljivostnih reakcij s ferumoksitolom.
In all three studies, patients with CKD and iron deficiency anaemia were randomized to treatment with Rienso or oral iron. 
V vseh treh študijah so bili bolniki s kronično ledvično boleznijo in anemijo zaradi pomanjkanja železa randomizirani v zdravljenje z zdravilom Rienso ali peroralnim železom.
Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into haemoglobin. 
Železo nato bodisi vstopa v intracelularne zaloge železa (npr. feritin) ali pa se prenese v plazemski transferin za transport v eritroidne prekurzorske celice za vključitev v hemoglobin.
Patients should be monitored for signs and symptoms of hypotension following each Rienso administration. 
Bolnike je treba nadzirati glede znakov in simptomov hipotenzije po vsakem dajanju zdravila Rienso.
Serious hypersensitivity or hypotensive reactions are uncommon (less than 1 case per 100 patients) and were reported in 0.2% (3/1562) of subjects with CKD who received Rienso during the clinical studies. 
Resna preobčutljivost ali hipotenzivne reakcije so občasne (manj kot 1 primer na 100 bolnikov) in so o njih poročali pri 0,2 % (3/1.562) preiskovancev s kronično ledvično boleznijo, ki so med kliničnimi študijami prejeli zdravilo Rienso.
The healthcare professional checklist shall contain the following messages: 
Obrazec za zdravstvene delavce mora vsebovati naslednje sporočilo:
Rienso is available in packs sizes of 1, 2, 6 or 10 vials. 
Zdravilo Rienso je na voljo v velikostih pakiranja po 1, 2, 6 ali 10 vial.
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. 
Ta vključuje izhodišče in srednjo spremembo glede na 35. dan za hemoglobin (Hgb, g/dl), nasičenost transferina (TSAT, %) in feritin (ng/ml) ter razmerje Hgb-odzivnih oseb na 35. dan (opredeljeno kot delež oseb s povečanjem Hgb za vsaj 1,0 g/dl) za vsako skupino zdravljenih v študijah 1, 2, in 3.
Life-threatening Anaphylactic/Anaphylactoid reactions* 
življenje ogrožajoče anafilaktične/ anafilaktoidne reakcije*
Before administration, the vials will be inspected by the person administering the medicine for signs of damage or deterioration. 
Pred uporabo bo oseba, ki vam bo zdravilo dala, vialo pregledala za znake poškodb ali kvarjenja.
Ethanol and sodium content 
Etanol in vsebnost natrija
For dilution instructions, please see section 4.2. 
Za navodila glede redčenja glejte poglavje 4.2.
The recommended course of Rienso is based on the patient's pre-treatment haemoglobin and body weight as provided in Table 1. 
Priporočeni potek zdravljenja z zdravilom Rienso temelji na vrednosti hemoglobina pred zdravljenjem in telesni masi bolnika, kot je prikazano v preglednici 1.
Oral Iron n = 76 
Peroralno železo n = 76
17 ml of solution in a vial (type I glass) with a stopper (chlorobutyl rubber) and an aluminium crimp-on seal. 
17 ml razopine v eni viali (steklo tipa I) z zamaškom (klorobutilna guma) in aluminijasto zaporko.
Before you were prescribed Rienso, the doctor will have carried out a blood test to make sure that you have iron deficiency anaemia. 
Preden vam bo zdravnik predpisal zdravilo Rienso, bo opravil preiskave krvi za potrditev, da ste slabokrvni zaradi pomanjkanja železa.
Rienso n = 228 
Zdravilo Rienso n = 228
It is unknown whether Rienso is excreted in human milk. 
Ni znano, ali se zdravilo Rienso izloča v materino mleko.
Rienso n = 114 
Zdravilo Rienso n = 114
• Administer a single vial as an infusion. 
• Dajte le eno vialo v obliki infuzije.
The pharmacokinetic (PK) behaviour of Rienso has been examined in healthy subjects and in patients with CKD stage 5D on haemodialysis. 
Farmakokinetično vedenje zdravila Rienso so ovrednotili pri zdravih prostovoljcih in pri bolnikih s kronično ledvično boleznijo stopnje 5D na hemodializi.
• The checklist should include tick-boxes to check and document: o Confirmation on appropriate settings (emergency resuscitation equipment available ) prior to administration of ferumoxytol o Semi-reclined position during administration o Duration of monitoring of patients after administration. 
• Obrazec mora vključevati okvirčke za preverjanje in mora dokumentirati: o potrditev ustreznih pogojev (razpoložljiva oprema za oživljanje v nujnem primeru) pred o trajanje spremljanja bolnikov po dajanju zdravila
Rate of infusion had no influence on Rienso PK parameters. 
Hitrost infundiranja ni vplivala na farmakokinetične parametre zdravila Rienso.
If you are breast-feeding, ask your doctor for advice before you are given Rienso. 
Če dojite, se posvetujte s svojim zdravnikom, preden dobite zdravilo Rienso.
Rienso should not be administered to patients with iron overload. 
Zdravila Rienso se ne sme dajati bolnikom, preobremenjenim z železom.
It includes iron oxide particles with an iron oxide core surrounded by a polyglucose sorbitol-carboxymethylether shell. 
Vključuje delce železovega oksida z jedrom železovega oksida, obdanim z ovojnico iz poliglukoze-sorbitolkarboksimetiletra.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label (1, 2, 6 or 10 vial pack) 
PODATKI NA ZUNANJI OVOJNINI Nalepka na škatli (pakiranje z 1, 2, 6 ali 10 vialami)
*Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting (see sections 4.3 and 4.4). 
*V obdobju trženja zdravila Rienso so opazili smrtne in življenjsko nevarne preobčutljivostne reakcije (glejte poglavji 4.3 in 4.4).
Excessive administration of Rienso may lead to accumulation of iron in storage sites potentially leading to haemosiderosis. 
Pretirana uporaba zdravila Rienso lahko povzroči kopičenje železa na mestih shranjevanja, ki lahko povzroči hemosiderozo.
510 mg iron (1 vial) 
510 mg železa (1 viala)
Oral Iron n = 116 
Peroralno železo n = 116