FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: - if you are scheduled for magnetic resonance imaging (an MRI scan), as this medicine may interfere with the interpretation of the scan.
Slovenian: - če imate načrtovano slikanje z magnetno resonanco (MR-slikanje), saj lahko to zdravilo vpliva na razlago izsledkov slikanja.
English: Rienso has not been tested in pregnant women.
Slovenian: Zdravilo Rienso ni bilo preskušeno pri nosečnicah.
English: 510 mg iron/17 ml
Slovenian: 510 mg železa / 17 ml
English: Available in packs sizes of 1, 2, 6 or 10 vials.
Slovenian: Na voljo je v velikostih pakiranja po 1, 2, 6 ali 10 vial.
English: 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.
Slovenian: 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.
English: Responders (%)
Slovenian: SD, %)
English: There are no adequate and well-controlled trials of Rienso in pregnant women.
Slovenian: Ustreznih in dobro kontroliranih preskušanj o uporabi zdravila Rienso pri nosečnicah ni na voljo.
English: - if your anaemia is not caused by iron deficiency.
Slovenian: - če vzrok vaše slabokrvnosti ni pomanjkanje železa.
English: Rienso is not recommended in women of childbearing potential not using adequate contraception.
Slovenian: Uporabe zdravila Rienso se ne priporoča pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Cumulatively 21 cases of hypersensitivity (8 serious, 13 non-serious) have been reported during clinical trials.
Slovenian: Med kliničnimi preskušanji so kumulativno poročali o 21 primerih preobčutljivosti (8 resnih, 13 primerih, ki niso bili resni).
English: Your doctor or nurse will administer Rienso by infusion into a vein.
Slovenian: Zdravnik ali medicinska sestra vam bosta dala zdravilo Rienso v obliki infuzije v veno.
English: What Rienso is and what it is used for
Slovenian: Kaj je zdravilo Rienso in za kaj ga uporabljamo
English: Other medicines and Rienso
Slovenian: Druga zdravila in zdravilo Rienso
English: It is used to treat iron deficiency anaemia resulting from a lack of stored iron, in adult patients with reduced kidney function.
Slovenian: Uporablja se za zdravljenje slabokrvnosti zaradi pomanjkanja železa, ki je posledica pomanjkanja zalog železa pri odraslih bolnikih z zmanjšanim delovanjem ledvic.
English: C-labelled product to lactating rats 10-11 days post-parturition, which peaked at 8 to 24 hours post-administration.
Slovenian: 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.
English: The vials should be inspected visually to ensure the absence of particulate matter and damage prior to administration.
Slovenian: Pred uporabo je treba vialo vizualno pregledati in zagotoviti odsotnost delcev ali poškodb.
English: 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.
Slovenian: 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.
English: Studies 1 and 2 enrolled patients with non-dialysis dependent CKD and Study 3 enrolled patients who were undergoing haemodialysis.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Black to reddish brown solution Osmolality: 270-330 mosm/kg pH: 6.5 to 8.0
Slovenian: raztopina za infundiranje črna do rdečkasto-rjava raztopina osmolalnost: 270-330 mosm/kg pH: 6,5 do 8,0
English: Summary of Efficacy Endpoints at Day 35 (Intent to Treat Population)
Slovenian: Preglednica 3: Povzetek ciljev učinkovitosti 35. dan (vsi vključeni bolniki)
English: If you are on haemodialysis, you may receive Rienso via infusion over 15 minutes during a dialysis session.
Slovenian: Če ste na hemodializi, boste morda prejeli zdravilo Rienso prek infuzije, ki traja 15 minut, med dializo.
English: 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.
Slovenian: 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.
English: Rienso contains ethanol and sodium
Slovenian: Zdravilo Rienso vsebuje etanol in natrij
English: After the DLP of the present PSUR, 6 additional fatal cases of hypersensitivity reactions with ferumoxytol have been reported.
Slovenian: Po datum zaključka zbiranja podatkov za sedanji PSUR so poročali o 6 dodatnih smrtnih primerih zaradi preobčutljivostnih reakcij s ferumoksitolom.
English: In all three studies, patients with CKD and iron deficiency anaemia were randomized to treatment with Rienso or oral iron.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Patients should be monitored for signs and symptoms of hypotension following each Rienso administration.
Slovenian: Bolnike je treba nadzirati glede znakov in simptomov hipotenzije po vsakem dajanju zdravila Rienso.
English: 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.
Slovenian: 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.
English: The healthcare professional checklist shall contain the following messages:
Slovenian: Obrazec za zdravstvene delavce mora vsebovati naslednje sporočilo:
English: Rienso is available in packs sizes of 1, 2, 6 or 10 vials.
Slovenian: Zdravilo Rienso je na voljo v velikostih pakiranja po 1, 2, 6 ali 10 vial.
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.
Slovenian: 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.
English: Life-threatening Anaphylactic/Anaphylactoid reactions*
Slovenian: življenje ogrožajoče anafilaktične/ anafilaktoidne reakcije*
English: Before administration, the vials will be inspected by the person administering the medicine for signs of damage or deterioration.
Slovenian: Pred uporabo bo oseba, ki vam bo zdravilo dala, vialo pregledala za znake poškodb ali kvarjenja.
English: Ethanol and sodium content
Slovenian: Etanol in vsebnost natrija
English: For dilution instructions, please see section 4.2.
Slovenian: Za navodila glede redčenja glejte poglavje 4.2.
English: The recommended course of Rienso is based on the patient's pre-treatment haemoglobin and body weight as provided in Table 1.
Slovenian: Priporočeni potek zdravljenja z zdravilom Rienso temelji na vrednosti hemoglobina pred zdravljenjem in telesni masi bolnika, kot je prikazano v preglednici 1.
English: Oral Iron n = 76
Slovenian: Peroralno železo n = 76
English: 17 ml of solution in a vial (type I glass) with a stopper (chlorobutyl rubber) and an aluminium crimp-on seal.
Slovenian: 17 ml razopine v eni viali (steklo tipa I) z zamaškom (klorobutilna guma) in aluminijasto zaporko.
English: Before you were prescribed Rienso, the doctor will have carried out a blood test to make sure that you have iron deficiency anaemia.
Slovenian: Preden vam bo zdravnik predpisal zdravilo Rienso, bo opravil preiskave krvi za potrditev, da ste slabokrvni zaradi pomanjkanja železa.
English: Rienso n = 228
Slovenian: Zdravilo Rienso n = 228
English: It is unknown whether Rienso is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Rienso izloča v materino mleko.
English: Rienso n = 114
Slovenian: Zdravilo Rienso n = 114
English: • Administer a single vial as an infusion.
Slovenian: • Dajte le eno vialo v obliki infuzije.
English: The pharmacokinetic (PK) behaviour of Rienso has been examined in healthy subjects and in patients with CKD stage 5D on haemodialysis.
Slovenian: Farmakokinetično vedenje zdravila Rienso so ovrednotili pri zdravih prostovoljcih in pri bolnikih s kronično ledvično boleznijo stopnje 5D na hemodializi.
English: • 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.
Slovenian: • 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
English: Rate of infusion had no influence on Rienso PK parameters.
Slovenian: Hitrost infundiranja ni vplivala na farmakokinetične parametre zdravila Rienso.
English: If you are breast-feeding, ask your doctor for advice before you are given Rienso.
Slovenian: Če dojite, se posvetujte s svojim zdravnikom, preden dobite zdravilo Rienso.
English: Rienso should not be administered to patients with iron overload.
Slovenian: Zdravila Rienso se ne sme dajati bolnikom, preobremenjenim z železom.
English: It includes iron oxide particles with an iron oxide core surrounded by a polyglucose sorbitol-carboxymethylether shell.
Slovenian: Vključuje delce železovega oksida z jedrom železovega oksida, obdanim z ovojnico iz poliglukoze-sorbitolkarboksimetiletra.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label (1, 2, 6 or 10 vial pack)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Nalepka na škatli (pakiranje z 1, 2, 6 ali 10 vialami)
English: *Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting (see sections 4.3 and 4.4).
Slovenian: *V obdobju trženja zdravila Rienso so opazili smrtne in življenjsko nevarne preobčutljivostne reakcije (glejte poglavji 4.3 in 4.4).
English: Excessive administration of Rienso may lead to accumulation of iron in storage sites potentially leading to haemosiderosis.
Slovenian: Pretirana uporaba zdravila Rienso lahko povzroči kopičenje železa na mestih shranjevanja, ki lahko povzroči hemosiderozo.
English: 510 mg iron (1 vial)
Slovenian: 510 mg železa (1 viala)
English: Oral Iron n = 116
Slovenian: Peroralno železo n = 116
English: Clinical presentation has included anaphylactic type reactions presenting with cardiac arrest/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness (see section 4.8).
Slovenian: Klinični znaki so vključevali reakcije anafilaktičnega tipa, ki so se manifestirale kot zastoj srca/zastoj srca in dihanja, klinično pomembna hipotenzija, sinkopa in neodzivnost (glejte poglavje 4.8).
English: Dosing should begin when blood pressure is stable and the patient has completed at least one hour of haemodialysis.
Slovenian: Odmerjanje naj se začne, ko je krvni tlak stabilen in je bil bolnik že vsaj eno uro na hemodializi.
English: Intravenous use by infusion.
Slovenian: Način uporabe intravenska uporaba v obliki infuzije
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).
Slovenian: V 4-tedenski študiji toksičnosti pri ponavljajočih odmerkih na podganah so po 26 tednih okrevanja ugotovili spremembe na jetrih (fokalne ali multifokalne krvavitve, hemoragično nekrozo, kronično vnetje in/ali hiperplazijo žolčnih vodov) pri samicah (kumulativni ekvivalentni človeški odmerek za uporabljeni skupini odmerkov ustreza varnostnima količnikoma 5,1 in 10,5 glede na kumulativni terapevtski človeški odmerek (2 x 510 mg Fe) za človeka s telesno maso 60 kg).
English: What Rienso looks like and contents of the pack
Slovenian: Izgled zdravila Rienso in vsebina pakiranja
English: Table 2 presents all adverse experiences observed during the clinical studies in which 1562 subjects with CKD received two injections of 510 mg of Rienso separated by an interval of 2 to 8 days and post-marketing experience.
Slovenian: V preglednici 2 so predstavljeni vsi neželeni učinki, ki so jih opazili med kliničnimi študijami, v katerih je 1.562 oseb s kronično ledvično boleznijo prejelo dve injekciji po 510 mg zdravila Rienso v intervalu 2 do 8 dni in v obdobju trženja.
English: Rienso can affect the interpretation of your blood iron test results.
Slovenian: Zdravilo Rienso lahko vpliva na razlago izvidov preiskave železa v krvi.
English: Lacrimation increased Vision blurred
Slovenian: Očesne bolezni povečano solzenje zemegljen vid
English: Rienso should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available.
Slovenian: Zdravilo Rienso se sme dati samo, če je osebje, usposobljeno za vrednotenje in zdravljenje anafilaktičnih reakcij, lahko takoj dosegljivo.
English: The MAH is of the opinion that the current EU SmPC accurately reflects the current literature and provides appropriate guidance to EU practitioners.
Slovenian: Imetnik dovoljenja za promet z zdravilom je mnenja, da trenutni povzetek glavnih značilnosti zdravila za EU natančno podaja trenutno razpoložljive vire in ustrezno usmerja zdravnike v EU.
English: Anticipated MR imaging studies should be conducted prior to the administration of Rienso.
Slovenian: Načrtovane študije slikanja z magnetno resonanco je treba opraviti pred dajanjem zdravila Rienso.
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.
Slovenian: Vendar pa je potrebna previdnost pri razlaganju ravni železa v serumu v 24 urah po dajanju zdravila Rienso, saj lahko laboratorijski testi pokažejo zvišano železo v serumu in železo, vezano na transferin, zaradi sočasnega merjenja železa v zdravilu Rienso.
English: Shelf-life after first opening and after dilution for infusion:
Slovenian: Rok uporabnosti po prvem odprtju in redčenju pred infundiranjem:
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).
Slovenian: V študiji prenatalnega in postnatalnega razvoja pri podganah so opazili neželene učinke na spolno dozorevanje in na reproduktivno sposobnost v generaciji F1 (glejte poglavje 5.3).
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.
Slovenian: Dajanje zdravila Rienso kuncem med organogenezo je povzročilo zmanjšano telesno maso plodov in zunanje deformacije in/ali deformacije mehkega tkiva (nepravilno obrnjene ali upognjene sprednje in obrnjene zadnje okončine, interni hidrocefalus, odsotnost možgan, palatoshiza in mikroglosija) pri velikem odmerku 45,3 mg Fe/kg/dan (kar ustreza odmerku 14,6 mg Fe/kg/dan pri človeku), odmerku, ki je le minimalno toksičen za mater.
English: The aim of Rienso therapy is to replenish the body's iron stores.
Slovenian: Cilj zdravljenja z zdravilom Rienso je napolniti zaloge železa v telesu.
English: Rienso is indicated for the intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).
Slovenian: Zdravilo Rienso je indicirano za intravensko zdravljenje anemije zaradi pomanjkanja železa pri odraslih bolnikih s kronično ledvično boleznijo.
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.
Slovenian: Po uporabi dveh 510 mg odmerkov zdravila Rienso, danih intravensko v roku 24 ur, je bila ocenjena vrednost očistka 69,1 ml/uro in Vd 3,3L.
English: Taking into account the PRAC Assessment Report on the PSUR for Rienso, the scientific conclusions of PRAC are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednega posodobljenega poročila o varnosti zdravila (PSUR) za zdravilo Rienso je odbor PRAC sprejel naslednje znanstvene zaključke:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, local tolerance and immunotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, lokalne tolerance in imunotoksičnosti ne kažejo posebnega tveganja za človeka.
English: No gender differences in Rienso PK parameters were observed.
Slovenian: Razlik med spoloma pri farmakokinetičnih parametrih zdravila Rienso niso opazili.
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.
Slovenian: V 24 urah po dajanju zdravila Rienso lahko laboratorijski testi pokažejo previsoko vrednost železa v serumu in železa vezanega na transferin, ker izmerijo tudi železo v kompleksu zdravila Rienso.
English: 5.2 Pharmacokinetic Properties
Slovenian: 5.2 Farmakokinetične lastnosti
English: P: +45 4677 1111
Slovenian: Tel.: +45 4677 1111
English: Adverse reactions observed during clinical studies and post-marketing
Slovenian: Preglednica 2: Neželeni učinki, ki so jih opazili med kliničnimi študijami in v obdobju trženja ORGANSKI
English: UNCOMMON (≥ 1/1,000 to
Slovenian: OBČASNI (≥1/1.000 do
English: It is not recommended to administer Rienso to patients with ongoing bacteraemia.
Slovenian: Dajanja zdravila Rienso bolnikom, ki imajo bakteriemijo, se ne priporoča.
English: Rienso is an iron preparation, containing the active substance ferumoxytol, which is given by infusion into a vein.
Slovenian: Zdravilo Rienso je zdravilo z železom, ki vsebuje zdravilno učinkovino ferumoksitol, ki se daje z infuzijo v veno.
English: Rienso was administered as two 510 mg intravenous injections (separated by 2 to 8 days) and oral iron (ferrous fumarate) was administered at a total daily dose of 200 mg elemental iron for 21 days.
Slovenian: Zdravilo Rienso so dali v obliki dveh 510 mg intravenskih injekcij (v razmiku 2 do 8 dni), peroralno železo (železov fumarat) pa so dajali 21 dni v skupnem dnevnem odmerku 200 mg elementarnega železa.
English: No carcinogenicity studies were performed with Rienso.
Slovenian: Z zdravilom Rienso niso izvajali študij kancerogenosti.
English: The iron is then released intracellularly from the iron-carbohydrate complex within vesicles in macrophages.
Slovenian: Železo se potem sprošča intracelularno iz kompleksa železo-ogljikov hidrat v veziklih makrofagov.
English: Tachycardia/Arrhythmia, Cardiac arrest Cardio-respiratory arrest Myocardial infarction Cyanosis
Slovenian: Srčne bolezni tahikardija/aritmija zastoj srca zastoj srca in dihanja miokardni infarkt cianoza kongestivno srčno popuščanje
English: Administration of Rienso during organogenesis in rats at maternally toxic doses of 100 mg Fe/kg/day caused a decrease in foetal weights.
Slovenian: Dajanje zdravila Rienso med organogenezo pri podganah z odmerki 100 mg Fe/kg/dan, toksičnimi za mater, so povzročili manjšo telesno maso zarodkov.
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
English: The Cmax and time of maximum concentration (tmax) were 206 mcg/ml and 0.32 hr, respectively.
Slovenian: Cmax je bil 206 mcg/ml in čas največje koncentracije (tmax) 0,32 ur.
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.
Slovenian: Slikanje z magnetno resonanco je mogoče razlagati prej, če je oseba, ki izsledke odčitava, seznanjena z nedavno aplikacijo zdravila Rienso ali z uporabo pulznega zaporedja magnetnoresonančnega slikanja, poudarjenega s T1 ali protoni.
English: No data from clinical trials are available regarding overdose of Rienso in humans.
Slovenian: Podatkov iz kliničnih preskušanj za preveliko odmerjanje zdravila Rienso pri ljudeh ni na voljo.
English: Any suspected adverse reactions should be reported via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.