FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic (PK) behaviour of Rienso has been examined in healthy subjects and in patients with CKD stage 5D on haemodialysis.
Danish: De farmakokinetiske (PK) egenskaber for Rienso er blevet undersøgt hos raske forsøgspersoner og hos patienter med CKD stadie 5D i hæmodialyse.
English: 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.
Danish: Skallen isolerer det bioaktive jern fra plasmakomponenterne, indtil jern-kulhydratkomplekset indtræder i det reticuloendoteliale systems makrofager i lever, milt og knoglemarv.
English: To maintain the target haemoglobin value, re-treatment with Rienso may be given after the patient has been re-assessed and confirmed to be iron deficient.
Danish: For at holde hæmoglobinniveauet kan yderligere behandlingforløb med Rienso gennemføres når patienten er revurderet og bekræftet at være i jernunderskud.
English: reactions to other injectable iron preparations.
Danish: (overfølsomhedsreaktioner) ved andre jernpræparater til injektion.
English: It includes iron oxide particles with an iron oxide core surrounded by a polyglucose sorbitol-carboxymethylether shell.
Danish: Det indeholder jernoxid-partikler med en jernoxidkerne omgivet af en skal af polyglucose-sorbitol-carboxymethylether.
English: In the Rienso and oral iron groups, 42% and 44% of patients, respectively, were receiving erythropoiesis stimulating agents (ESAs) at Baseline.
Danish: I grupperne med Rienso og oralt jern fik henholdsvis 42 % og 44 % af patienterne erytropoiese-stimulerende midler (ESAs) ved baseline.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Rienso in one or more subsets of the paediatric population in the treatment of iron deficiency anaemia (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Rienso i en eller flere undergrupper af den pædiatriske population ved behandling af jernmangelanæmi (se pkt.
English: Limited clinical study data is available regarding re-treatment with Rienso and no clinical study data is available for repeated long term use.
Danish: Der er begrænset mængde data fra kliniske studier tilgængelige vedrørende yderligere behandlingsforløb med Rienso, og der findes ingen data fra kliniske studier for langtidsbehandling.
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.
Danish: De estimerede værdier for CL og Vd efter to 510 mg-doser Rienso administreret intravenøst inden for 24 timer var henholdsvis 69,1 ml/t og 3,3 liter.
English: Your doctor or nurse will administer Rienso by infusion into a vein.
Danish: Din læge eller sygeplejerske vil give dig Rienso ved en infusion i en blodåre.
English: For dilution instructions, please see section 4.2.
Danish: For instruktioner om fortynding, se pkt 4.2.
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.
Danish: Efter gennemførelse af den kontrollerede fase af hvert af fase 3-forsøgene kunne de patienter, der havde jernmangel og anæmi valgfrit blive genbehandlet og få to ekstra 510 mg intravenøse injektioner med Rienso og opnå en total kumulativ dosis på 2,04 g. I alt 69 patienter fik en total kumulativ dosis på 2,04 g. Bivirkningerne efter denne gentagne Rienso-dosering havde tilsvarende karakter og frekvens som det, der observeredes efter de første to intravenøse injektioner.
English: 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.
Danish: Det gennemsnitlige hæmoglobinniveau blev øget (0,5- 0,9 g/dl) efter behandlingen og stabiliseredes i området 11-11,7 g/dl over en 10 måneders periode efter doseringen; der identificeredes ingen nye sikkerhedssignaler ved gentagen dosering.
English: Excessive administration of Rienso may lead to accumulation of iron in storage sites potentially leading to haemosiderosis.
Danish: Overdreven administration af Rienso kan medføre akkumulation af jern i depoterne, hvilket kan medføre hæmosiderose.
English: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 17 ml vial.
Danish: Dette lægemiddel indeholder små mængder ethanol (alkohol), mindre end 100 mg per 17 ml hætteglas.
English: Rienso is available in packs sizes of 1, 2, 6 or 10 vials.
Danish: Rienso fås i pakningsstørrelser på 1, 2, 6 eller 10 hætteglas.
English: It is used to treat iron deficiency anaemia resulting from a lack of stored iron, in adult patients with reduced kidney function.
Danish: Det bruges til behandling af jernmangelanæmi som følge af manglende jernlagre hos voksne patienter med nedsat nyrefunktion.
English: 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.
Danish: Den behandling, du vil få, kan være 1 eller 2 hætteglas Rienso (à 510 mg) via infusion, og hver enkelt dosis indgives i en blodåre.
English: Interference with Magnetic Resonance Imaging (MRI) No spontaneous post-marketing reports of MRI interference have been received to date.
Danish: Forstyrrelse i forbindelse med MR (Magnetressonans-scanning) Der er til dato ikke modtaget nogen spontane indberetninger efter markedsføring om MR-påvirkning.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes umiddelbart efter anbrud og fortynding.
English: Patients should be re-assessed at least one month after the completion of a course of Rienso and this should include laboratory testing of haematologic and blood iron parameters.
Danish: Patienter bør tidligst revurderes en måned efter et gennemført/afsluttet behandlingsforløb med Rienso, og revurderingen skal omfatte laboratorietestning af hæmatologiske - og blod-jern-parametre.
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.
Danish: Tabel 2 viser alle hændelser, der er observeret under de kliniske studier, hvor 1.562 forsøgspersoner med CKD fik to injektioner a 510 mg Rienso med et interval på 2-8 dage og post-marketing erfaring.
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.
Danish: Dette omfatter baseline og gennemsnitlig ændring frem til dag 35 i hæmoglobin (Hgb, g/dl), transferrinmætning (TSAT, %) og ferritin (ng/ml) samt den andel af forsøgspersonerne, der var Hgb-respondenter på dag 35 (defineret som andelen af forsøgspersoner med en forhøjelse af Hgb på mindst 1,0 g/dl) i hver enkelt behandlingsgruppe for studie 1, 2 og 3.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 510 mg/17 ml
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 510 mg/17 ml
English: - if you have a history of medicine allergy or have experienced serious allergic (hypersensitive)
Danish: - hvis du har en kendt lægemiddelallergi eller har oplevet alvorlige allergiske reaktioner
English: Therefore Rienso should not be administered to children and adolescents below the age of 18 years (see section 5.1).
Danish: Derfor bør Rienso ikke administreres til børn og teenagere under 18 år (se pkt.
English: 510 mg iron/17 ml
Danish: 510 mg jern/17 ml
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
Danish: • Holdbarhed efter anbrud og efter fortynding til infusion: Kemisk og fysisk in use holdbarhed er dokumenteret i 96 timer ved 25 °C
English: Lacrimation increased Vision blurred
Danish: Øget tåresekretion Uklart syn
English: 17 ml of solution in a vial (type I glass) with a stopper (chlorobutyl rubber) and an aluminium crimp-on seal.
Danish: 17 ml opløsning i et hætteglas (type I glas) med en prop (chlorbutylgummi) og en aluminiumkrympetætning.
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.
Danish: • Tjeklisten skal indeholde afkrydsningsfelter for at kontrollere og dokumentere: o Bekræftelse vedrørende egnede omgivelser (tilgængeligt genoplivningsudstyr) forud for administration af ferumoxytol o Patientens egnethed o Kontraindikationer og advarsler o Administrationens varighed o Halvt liggende stilling under administration o Varighed af monitoreringen af patienter efter administration.
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.
Danish: I kliniske forsøg med 1.562 forsøgspersoner med CKD observeredes bivirkninger hos 7,9 % af de patienter, der fik Rienso, hvoraf 0,2 % ansås for alvorlige.
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.
Danish: MR-billeder kan tolkes tidligere, hvis den, der aflæser dem, er vidende om, den nyelige administration af Rienso, eller ved at anvende T1- eller protondensitets-vægtede MR-impulssekvenser.
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.
Danish: Evnen til at producere afkom (reproduktionsevnen) var reduceret ved høje doser hos handyr og hos hundyr ved middel og høje doser, uanset om F1-hanner blev parret med F1-hunner, eller F1-hanner blev parret med naive hunner og omvendt.
English: Talk to your doctor, pharmacist or nurse before receiving Rienso: - if you have a history of medicine allergy.
Danish: Kontakt lægen eller sundhedspersonalet, før du får Rienso: - hvis du tidligere har haft medicinallergi.
English: Patients should be monitored for signs and symptoms of hypotension following each Rienso administration.
Danish: Patienterne skal monitoreres for objektive fund og symptomer på hypotension efter hver administration af Rienso.
English: Rienso is indicated for the intravenous treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).
Danish: Rienso er indiceret til intravenøs behandling af jernmangelanæmi hos voksne patienter med kronisk nyreinsufficiens (CKD).
English: The aim of Rienso therapy is to replenish the body's iron stores.
Danish: Formålet med Rienso-behandlingen er at fylde kroppens jerndepoter op.
English: The safety and efficacy of Rienso in children and adolescents below the age of 18 years has not been established.
Danish: Riensos sikkerhed og virkning hos børn og teenagere under 18 år er ikke klarlagt.
English: Before administration, the vials will be inspected by the person administering the medicine for signs of damage or deterioration.
Danish: Inden administrationen efterser den person, der skal indgive medicinen, hætteglassene for tegn på skader eller nedbrydning.
English: 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.
Danish: Det skal besluttes, om amning eller behandling med Rienso skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier over eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler end dem, der er anført under pkt.
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.
Danish: Derefter indtræder jernet enten ind i det intracellulære jerndepot (fx ferritin) eller det overføres til plasmatransferrin med henblik på transport til erytroide precurser celler, så de kan indkorporereres i hæmoglobin.
English: 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).
Danish: Risikoen er højere hos patienter med kendte allergier, herunder lægemiddelallergier, og hos patienter med svær astma, eksem eller anden atopisk allergi i anamnesen (se pkt.
English: What Rienso contains
Danish: Rienso indeholder
English: The healthcare professional checklist shall contain the following messages:
Danish: Sundhedspersonens tjekliste skal indeholde følgende oplysninger:
English: Rienso is an iron preparation, containing the active substance ferumoxytol, which is given by infusion into a vein.
Danish: Rienso er et jernpræparat som indeholder det aktive stof ferumoxyol, der indgives som infusion i en blodåre.
English: For patients receiving two doses, the second 510 mg infusion is to be administered 2 to 8 days later as per Table1.
Danish: For patienter, der får to doser, skal den anden 510 mg infusion administreres mellem 2 og 8 dage senere, som anvist i tabel 1.
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.
Danish: Indehaveren af markedsføringstilladelsen skal gennemføre et studie for at undersøge mekanismerne i overfølsomhed forbundet med eksponering for ferumoxytol i henhold til en protokol aftalt med CHMP.
English: Any suspected adverse reactions should be reported via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: For patients receiving two vials, the second one will be infused two to eight days after the first infusion.
Danish: For patienter, der får to hætteglas, indgives det andet to til otte dage efter den første infusion.
English: Iron is an essential element required to make haemoglobin, a molecule in red blood cells that enables oxygen to be carried around the body.
Danish: Jern er et vigtigt stof for dannelse af hæmoglobin, et molekyle i de røde blodceller, som betyder at ilten kan transporteres rundt i kroppen.
English: Available in packs sizes of 1, 2, 6 or 10 vials.
Danish: Fås i pakningsstørrelser på 1, 2, 6 eller 10 hætteglas.
English: 9.7 mg Fe/kg/day, respectively) sexual maturation was delayed and a disruption of the oestrus cycle was noted in some females.
Danish: Fe/kg/dag og 9,7 mg Fe/kg/dag), var kønsmodningen forsinket og der bemærkedes en afbrydelse af brunstcyklus i nogle hundyr.
English: Haemodialysis patients:
Danish: Hæmodialysepatienter:
English: Fatal and life-threatening hypersensitivity reactions have been observed with Rienso in the post marketing setting.
Danish: Dødelig og livstruende overfølsomhedsreaktioner med Rienso er forekommet efter markedsføring af produktet.
English: It is not recommended to administer Rienso to patients with ongoing bacteraemia.
Danish: Det anbefales ikke at administrere Rienso til patienter med aktiv bakteriæmi.
English: Rienso is a colloidal iron-carbohydrate complex.
Danish: Rienso er et kolloidt jern-kulhydratkompleks.
English: • No other intravenous dilution solutions and therapeutic agents should be used.
Danish: • Der må ikke anvendes andre intravenøse fortyndingsopløsninger og terapeutiske midler.
English: No data from clinical trials are available regarding overdose of Rienso in humans.
Danish: Der er ingen tilgængelige data fra kliniske forsøg vedrørende overdosering af Rienso til mennesker.
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.
Danish: Rienso blev administreret som to 510 mg intravenøse injektioner (med 2-8 dages mellemrum), og oralt jern (ferrofumarat) blev administreret som en samlet daglig dosis på 200 mg usammensat jern i 21 dage.
English: The vials should be inspected visually to ensure the absence of particulate matter and damage prior to administration.
Danish: Hætteglassene skal kontrolleres visuelt før administration for at sikre, at der ikke er nogen partikler og skader.
English: Administration of Rienso during organogenesis in rats at maternally toxic doses of 100 mg Fe/kg/day caused a decrease in foetal weights.
Danish: Administration af Rienso under organogenese hos rotter i doser, der er toksiske for moderdyret, (100 mg Fe/kg/dag) forårsagede et fald i fødselsvægten.
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,
Danish: I et diestudie på rotter: Der var minimal udskillelse af Rienso eller Rienso-deriveret radioaktivitet i mælk efter en enkelt IV administration på cirka 100 mg Fe/kg (HED på 16,1 mg Fe/kg, cirka 2 gange den anbefalede humandosis på 510 mg baseret på mg/m2) af enten det umærkede,
English: 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.
Danish: Derfor mente PRAC, ud fra de tilgængelige data vedrørende overfølsomhedsreaktioner og interferens med magnetresonansscanning (MR), at ændringer af produktoplysningerne og betingelserne for markedsføringstilladelsen var berettigede.
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.
Danish: I 24 timer efter administration af Rienso, kan laboratorieanalyser overvurdere serum-jern og transferrin-bundet jern ved også at måle jernet i Rienso-komplekset.
English: In the case of symptoms of dizziness, confusion or light headedness following the administration of Rienso, patients should not drive or use machinery until the symptoms have ceased.
Danish: Rienso kan i mindre grad påvirke evnen til at føre motorkøretøj eller betjene maskiner: I tilfælde af symptomer som svimmelhed eller konfusion efter administration af Rienso bør patienterne ikke føre motorkøretøj eller betjene maskiner, før symptomerne er ophørt.
English: Rienso will be administered in an environment where any allergic event can receive appropriate and prompt treatment.
Danish: Din behandling med Rienso gives på et sted, hvor enhver allergisk hændelse straks kan blive behandlet på passende måde.
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,
Danish: Bivirkninger med ukendt frekvens (hyppigheden kan ikke vurderes ud fra de tilgængelige data) Følgende alvorlige bivirkninger er blevet indberettet kort efter administration af Rienso: - Livstruende og dødelige allergiske reaktioner (anafylaktisk/anafylaktoid overfølsomhed) - Hjerte-/karkomplikationer (som påvirker hjerte og blodkar) herunder hjerteanfald, hjertestop,
English: - if you have iron overload (too much iron in your body).
Danish: - hvis du har for meget jern i kroppen.
English: 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.
Danish: Begrundelser for at anbefale ændring af betingelserne for markedsføringstilladelsen På baggrund af de videnskabelige konklusioner for Rienso er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel, der indeholder det aktive stof ferumoxytol, er gunstigt under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: UNCOMMON (≥ 1/1,000 to
Danish: ALMINDELIG (≥1/1.000 til
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.
Danish: For patienter i hæmodialyse bør Rienso først administreres, når blodtrykket er stabilt, og patienten har gennemgået mindst en time af hæmodialysen.
English: 5.2 Pharmacokinetic Properties
Danish: 5.2 Farmakokinetiske egenskaber
English: Overdose should be treated, if required, with an iron chelating agent.
Danish: Overdosering skal behandles, om nødvendigt, med et jernkeleringsmiddel.
English: No adverse effects on fertility or general reproductive performance were noted in adult rats (see Section 5.3).
Danish: Der er ikke set indvirkninger på fertiliteten eller reproduktionsevnen hos voksne rotter (se pkt.
English: Dosing should begin when blood pressure is stable and the patient has completed at least one hour of haemodialysis.
Danish: Doseringen skal påbegyndes, når blodtrykket er stabilt, og patienten har gennemgået mindst en times hæmodialyse.
English: No other intravenous dilution solutions and therapeutic agents should be used.
Danish: Der må ikke anvendes andre intravenøse fortyndingsopløsninger og terapeutiske substanser.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rienso 30 mg/ml infusion
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Rienso 30 mg/ml infusionsvæske
English: Rienso is not recommended in women of childbearing potential not using adequate contraception.
Danish: Rienso bør ikke anvendes til kvinder i den fertile alder, som ikke anvender sikker kontraception.
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).
Danish: I et præ- og postnatalt udviklingsstudie på rotter var kønsmodningen forsinket hos hanunger ved den høje dosis på 60 mg Fe/kg/dag (HED på 9,7 mg Fe/kg/dag).
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
Danish: Hos hunungerne i middel og høj dosisgrupperne (på henholdsvis 30 mg Fe/kg/dag og 60 mg Fe/kg/dag (HED på henholdsvis 4,8 mg