FrancophonIA/ELRC3.0 huggingface dataset:
English: • Patients with any known history of drug allergy including hypersensitivity to other parenteral iron products
Danish: • Patienter med enhver kendt lægemiddelallergi herunder overfølsomhed over for andre parenterale jernpræparater
English: Other side effects that you should tell your doctor, pharmacist or nurse about if they become serious:
Danish: Andre bivirkninger, som du skal fortælle lægen eller sygeplejersken om, hvis de bliver alvorlige:
English: Magnetic Resonance (MR) Imaging
Danish: Magnetisk Resonans (MR)-scanning
English: All six fatal hypersensitivity cases were reported in the US and involved elderly patients (> 65 years of age) with co-morbidities.
Danish: Alle seks dødelig overfølsomhedstilfælde blev indberettet i USA og omfattede ældre patienter (> 65 år) med co-morbiditeter.
English: The use of Rienso is contraindicated in cases of:
Danish: Brugen af Rienso er kontraindiceret ved:
English: Cumulatively 21 cases of hypersensitivity (8 serious, 13 non-serious) have been reported during clinical trials.
Danish: Kumulativt 21 tilfælde af hypersensitivitet (8 alvorlige, 13 ikke alvorlige) er blevet indberettet under kliniske forsøg.
English: Based on a limited number of case reports, the influence of ferumoxytol on the interpretation of MRIs, due to its unique crystalline structure appears to be primarily noted in the first few weeks after administration and, based on animal data, dissipated within 3 months.
Danish: Baseret på et begrænset antal indberetninger af tilfælde lader det til, at påvirkningen af ferumoxytol på fortolkningen af MR-scanninger på grund at dets unikke krystallinske struktur primært bemærkes i de første få uger efter administration og, baseret på data fra dyr, forsvinder inden for 3 måneder.
English: If you are pregnant, you should not receive Rienso.
Danish: Hvis du er gravid, skal du ikke have Rienso.
English: However, the MAH acknowledges that Rostoker and Cohen recommend a minimum of 6 months between ferumoxytol's administration, which they base on the study with 6 healthy volunteers published by Storey et al.
Danish: MAH erkender, at Rostoker og Cohen anbefaler mindst 6 måneder mellem administration af ferumoxytol og MR, hvilket de baserer på studiet af 6 raske frivillige publiceret af Storey et al.
English: It is unknown whether Rienso is excreted in human milk.
Danish: Det er ukendt, om Rienso udskilles i human mælk.
English: Each 510 mg dose is administered as an intravenous infusion for at least 15 minutes.
Danish: Hver 510 mg dosis administreres som en intravenøs infusion over mindst 15 minutter.
English: Parenteral iron should be used with caution in cases of immunologic disease or acute or chronic infection.
Danish: Parenteralt jern bør anvendes med forsigtighed i tilfælde af immunologisk sygdom eller akut eller kronisk infektion.
English: No studies regarding effects on the ability to drive or operate machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkninger på evnen til at føre motorkøretøj eller betjene maskiner.
English: Overdose can cause accumulation of iron in your body.
Danish: Overdosering kan medføre ophobning af jern i kroppen.
English: No drug-drug interaction studies have been performed.
Danish: Der er ikke udført interaktionsstudier.
English: Elderly patients (> 65 years of age) or patients with multiple co-morbidities who experience a serious hypersensitivity reaction may have more severe outcomes.
Danish: Ældre patienter (> 65 år) eller patienter med flere samtidige sygdomme, som oplever alvorlige overfølsomhedsreaktioner, kan have alvorligere konsekvenser.
English: If you are older than 65 years or have an underlying condition, such as liver or heart disease, the risk of having severe consequences including death may be higher after a serious allergic reaction.
Danish: Hvis du er over 65 år eller har en tilgrundliggende sygdom som fx lever- eller hjertesygdom, kan risikoen for at få alvorlige følger, herunder dø, være større efter en alvorlig allergisk reaktion.
English: Hgb = haemoglobin; TSAT = transferrin saturation; SD = standard deviation
Danish: Hgb = hæmoglobin; TSAT = transferrinmætning; SD = standarddeviation
English: Two of these reports were included by the MAH as late breaking information into this PSUR.
Danish: To af disse indberetninger var inkluderet af MAH som seneste information i denne PSUR.
English: Your doctor will decide how much Rienso to give you based on your weight and blood test results.
Danish: Din læge vil beslutte, hvor meget Rienso, du skal have, baseret på din vægt og dine blodprøveresultater.
English: As with all parenteral iron preparations the absorption of oral iron is reduced when administered concomitantly.
Danish: Som ved alle parenterale jernpræparater reduceres absorptionen af oralt indgivet jern ved samtidig administration.
English: Final study report by:
Danish: Endelig studieprotokol inden:
English: When there is insufficient iron in the body, haemoglobin cannot be formed, resulting in anaemia (low levels of haemoglobin).
Danish: Hvis der ikke er tilstrækkeligt jern i kroppen, kan der ikke dannes hæmoglobin, og det medfører anæmi (lavt niveau af hæmoglobin).
English: The patient alert card shall contain the following key messages:
Danish: Patientens advarselskort skal indeholde følgende vigtige oplysninger:
English: Water for Injections
Danish: Vand til injektion
English: Rienso has not been tested in pregnant women.
Danish: Rienso er ikke blevet afprøvet på gravide kvinder.
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.
Danish: Prækliniske data påviser ingen speciel risiko for mennesker vurderet ud fra traditionelle studier af sikkerhedsfarmakologi,gentaget dosis toksicitet, genotoksicitet, lokal tolerance og immuntoksicitet.
English: Rienso exhibited dose-dependent, capacity-limited elimination from plasma with a half life of approximately 16 hours in humans.
Danish: Rienso udviste dosisafhængig, kapacitetsbegrænsenset udskillelse fra plasma med en halveringstid på cirka 16 timer hos mennesker.
English: The maximum dose is 1020 mg (2 vials) and the two doses of Rienso must not be administered at the same time.
Danish: Den maksimale dosis er 1.020 mg (2 hætteglas), og de to doser Rienso må ikke administreres samtidig.
English: If you are able to become pregnant, you must use birth control during treatment.
Danish: Hvis du kan blive gravid, skal du benytte prævention under behandlingen.
English: For information on post-marketing experience see section 5.1.
Danish: For information om post-marketing erfaring se pkt.
English: Hyperventilation Hypoxia
Danish: Hyperventilation Hypoxi
English: Within the limitations inherent to post-marketing reporting, the following reporting rate can be calculated: As of 30 June 2014, the cumulative overall post-marketing reporting rate of hypersensitivity based on 2 g per person per year is: 527/266,914 × 100 = 0.20 %.
Danish: Inden for de begrænsninger, der ligger i indberetning efter markedsføring, kan følgende indberetningsgrad beregnes: Per 30. juni 2014 er den kumulative samlede indberetningsrate efter markedsføring for hypersensitivitet baseret på 2 g per person per år: 266.914 × 100 = 0,20 %.
English: Rienso should be administered as an intravenous infusion into a new or existing venous access site.
Danish: Rienso skal administreres som en intravenøs infusion på et nyt eller eksisterende venøst adgangssted.
English: 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.
Danish: Distributionsvolumen (Vd) var i overensstemmende med plasmavolumen, og de gennemsnitlige maksimale observerede værdier for plasmakoncentration (Cmax) og terminal halveringstid (t1/2) øgedes med dosis.
English: Rienso has not been specifically studied in patients with hepatic impairment; clinical experience is limited to 8 patients.
Danish: Rienso er ikke specifikt undersøgt hos patienter med nedsat leverfunktion; den kliniske erfaring er begrænset til 8 patienter.
English: ≤ 50 kg Body Weight
Danish: ≤50 kg kropsvægt
English: Prior to the use of Rienso in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden anvendelsen af Rienso i den enkelte medlemsstat skal indehaveren af markedsføringstilladelsen (MAH) opnå enighed den nationale besluttende myndighed om indholdet og formatet af uddannelsesprogrammet, herunder kommunikationsmidler, distributionsformer samt eventuelle andre aspekter af programmet.
English: He or she will also monitor your blood test results to avoid iron accumulation.
Danish: Han eller hun vil også overvåge dine blodprøveresultater for at undgå jernophobning.
English: Intravenous use by infusion.
Danish: Intravenøs anvendelse via infusion.
English: During the post-marketing phase, several patients received an overdose of Rienso ranging from 1 g in 1 day to 2.5 g over 21 days.
Danish: I fasen efter markedsføring fik flere patienter en overdosis af Rienso fra 1 g på 1 dag til 2,5 g over 21 dage.
English: • Healthcare professional checklist • Patient alert card
Danish: • Tjekliste for sundhedspersoner • Advarselskort til patienter
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).
Danish: Det er derfor nødvendigt omhyggeligt at vurdere fordele og ulemper inden brug under graviditet, og Rienso bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (se pkt.
English: For the same reason also talk to your doctor or radiographer if you have been given Rienso within the past 6 months and an MRI is subsequently arranged.
Danish: Af samme grund skal du også tale med din læge eller røntgenspecialist, hvis du har fået Rienso inden for de seneste 6 måneder, og der skal foretages en MR-scanning.
English: Rienso contains ethanol and sodium
Danish: Rienso indeholder ethanol og natrium
English: After the DLP of the present PSUR, 6 additional fatal cases of hypersensitivity reactions with ferumoxytol have been reported.
Danish: Efter DLP for den nuværende PSUR er yderligere 6dødelige tilfælde af overfølsomhedsreaktioner over for ferumoxytol blevet indberettet.
English: Re-treatment / Long term use
Danish: Yderligere behandlingsforløb/langtidsbehandling
English: Hypotension may follow Rienso administration with or without accompanying signs of hypersensitivity (see section
Danish: Hyopotension kan forekomme efter Rienso-administration med eller uden ledsagende tegn på overfølsomhed (se pkt.
English: You will be carefully observed during the infusion and for at least 30 minutes after each infusion by your doctor or nurse.
Danish: Du vil blive nøje overvåget under infusionen og i mindst 30 minutter efter hver infusion af lægen eller en sygeplejerske.
English: • Administer a single vial as an infusion.
Danish: • Indgiv et enkelt hætteglas som en infusion.
English: One patient had a prior history of drug allergy.
Danish: En af patienterne havde lægemiddelallergi i anamnesen.
English: Anticipated MR imaging studies should be conducted prior to the administration of Rienso.
Danish: Planlagte MR-undersøgelser bør udføres før administration af Rienso.
English: In all three studies, patients with CKD and iron deficiency anaemia were randomized to treatment with Rienso or oral iron.
Danish: I alle tre studier blev patienter med CKD og jernmangelanæmi randomiseret til behandling med Rienso eller oralt jern.
English: Rienso Administration
Danish: Administration af Rienso
English: If you are on haemodialysis, you may receive Rienso via infusion over 15 minutes during a dialysis session.
Danish: Hvis du er i hæmodialyse, kan du få Rienso via infusion over 15 minutter under dialyse.
English: Retrospective observational data from three large haemodialysis clinics in the US over a 1 year period included the treatment of over 8,600 patients with more than 33,300 administered doses of Rienso; nearly 50% of patients received repeat dosing with 4 or more doses.
Danish: Retrospektive observationsdata fra tre store hæmodialyseklinikker i USA over en 1-årig periode omfattede behandling af over 8.600 patienter med mere end 33.300 administrerede doser Rienso; næsten 50 % af patienterne fik gentagne doser med 4 eller flere doser.
English: Iron as ferumoxytol
Danish: Jern som ferumoxytol
English: The safety and efficacy of Rienso (cumulative dose of 1.02 grams) for the treatment of iron deficiency in CKD patients with IDA were assessed in three randomized, open-label, controlled clinical studies (Studies 1, 2 and 3).
Danish: Riensos sikkerhed og virkning (kumulativ dosis på 1,02 gram) til behandling af jernmangel hos CKDpatienter med IDA er blevet vurderet i tre randomiserede, open-label, kontrollerede kliniske studier (Studie 1, 2 og 3).
English: Children and adolescents Rienso should not be given to children and adolescents under 18 years old.
Danish: Børn og teenagere Rienso bør ikke gives til børn og teenagere under 18 år.
English: During this PSUR covering period, 45 new cases of hypersensitivity reactions have been reported: 24 serious including one fatal case already reported as part of the previous PSUR as late-breaking information and 21 non-serious cases.
Danish: I PSUR-dækningsperioden er der indberettet 45 nye tilfælde af overfølsomhedsreaktioner: 24 alvorlige inklusive et dødeligt tilfælde er allerede indberettet som en del af den tidligere PSUR som seneste information, og 21 ikke alvorlige tilfælde.
English: In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment.
Danish: Hos patienter med leverinsufficiens må parenteralt jern kun administreres efter omhyggelig vurdering af forholdet mellem risiko og fordele.
English: No carcinogenicity studies were performed with Rienso.
Danish: Der er ikke udført karcinogenicitetsstudier med Rienso.
English: 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).
Danish: Kumulativt, siden tildeling af markedsføringstilladelsen op til datalåsepunktet (data lock-point (DLP) for den aktuelle PSUR indberettedes i alt 527 tilfælde af overfølsomhedsreaktioner efter markedsføring, heraf var mere end 50 % alvorlige og omfattede livstruende allergiske reaktioner (264 alvorlige, 263 ikke alvorlige).
English: If you become pregnant during treatment, you must ask your doctor for advice.
Danish: Hvis du bliver gravid under behandlingen, skal du kontakte lægen.
English: There are no adequate and well-controlled trials of Rienso in pregnant women.
Danish: Der er ingen tilstrækkelige og velkontrollerede forsøg med anvendelse af Rienso til gravide kvinder.
English: Your doctor will monitor iron levels to avoid iron accumulation.
Danish: Din læge vil holde øje med jernniveauerne for at undgå ophobning.
English: Marketing authorisation holder: Takeda Pharma A/S Dybendal Alle 10
Danish: Indehaver af markedsføringstilladelsen: Takeda Pharma A/S Dybendal Alle 10
English: Life-threatening Anaphylactic/Anaphylactoid reactions*
Danish: Livstruende anafylaktiske/ anafyl-aktoide reaktioner*
English: SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATIONS
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ANBEFALING AF ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSERNE
English: The MAH shall ensure that in each Member State where Rienso is marketed, all healthcare professionals and patients/carers who are expected to use Rienso have access to/are provided with the following educational package:
Danish: MAH skal sørge for, at alle sundhedspersoner og patienter/plejere, der forventes at bruge Rienso i hver enkelt medlemsstat, hvor Rienso markedsføres, har adgang til/bliver udstyret med følgende uddannelsespakke:
English: Dry mouth Dyspepsia Glossodynia
Danish: Mundtørhed Dyspepsi Glossodyni
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 4 hours at 25 °C.
Danish: Hvis det ikke anvendes umiddelbart, er opbevaringstid under anvendelse og betingelser forud for anvendelsen brugerens ansvar og skal ikke være længere end 4 timer ved 25 °C.
English: In a placebo-controlled, cross-over trial, 713 patients with CKD received a single 510 mg dose of Rienso and placebo.
Danish: I et placebo-kontrolleret, cross-over-forsøg fik 713 patienter med CKD en enkelt 510 mg dosis Rienso og placebo.
English: Before you were prescribed Rienso, the doctor will have carried out a blood test to make sure that you have iron deficiency anaemia.
Danish: Før du får ordineret Rienso, har lægen taget en blodprøve for at sikre, at du har jernmangelanæmi.
English: Periodic monitoring of laboratory parameters of iron storage, such as serum ferritin and transferrin saturation, enables recognition of iron accumulation.
Danish: Jævnlig monitorering af laboratorieparametre for jerndepoter, så som serumferritin og transferrinmætning, muliggør opdagelse af akkumulation af jern.
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.
Danish: De hyppigst indberettede bivirkninger var gastrointestinale symptomer (diarré, obstipation, kvalme og opkastning), hovedpine, svimmelhed og hypotension, som alle forekom hos mindre end 2,5 % af patienterne.
English: Rienso will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound or nuclear medicine imaging.
Danish: Rienso vil ikke påvirke røntgenbilleder, computertomografi (CT-scanning), positronemissionstomografi (PET-scanning), enkelt fotonemissions-computertomografi (SPECT-scanning), ultralydsscanning eller nuklearmedicinsk billeddannelse.
English: The recommended course of Rienso is based on the patient's pre-treatment haemoglobin and body weight as provided in Table 1.
Danish: Det anbefalede behandlingsforløb med Rienso er baseret på patientens hæmoglobinværdi og kropsvægt i henhold til Tabel 1.
English: As seen from clinical data there is no evidence that these effects seen in female rats are relevant for humans.
Danish: Baseret på de kliniske data er der ingen evidens for at de effekter, som er set i hunrotter, har relevans for mennesker.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglasetiket
English: - if your anaemia is not caused by iron deficiency.
Danish: - hvis din anæmi skyldes andet end jernmangel.
English: Ethanol and sodium content
Danish: Ethanol og natrium indhold
English: • Information regarding the increased risk of serious including fatal hypersensitivity reactions: contraindications, special patient populations (e.g. pregnant women, elderly), warnings, symptoms of hypersensitivity reactions, monitoring by health care professionals during 30 minutes after administration, warning on late onset of allergic reactions.
Danish: • Informationer vedrørende øget risiko for alvorlige, inklusive livstruende, overfølsomhedsreaktioner: Kontraindikationer, særlige patientpopulationer (fx gravide kvinder, ældre), advarsler, symptomer på overfølsomhedsreaktioner, monitorering foretaget af sundhedspersoner i 30 minutter efter administrationen, advarsel om sent indsættende allergiske reaktioner.
English: No gender differences in Rienso PK parameters were observed.
Danish: Der observeredes ingen kønsforskelle i Riensos PK-parametre.
English: Doctors are aware of these possible side effects and will monitor you during the infusion and for at least 30 minutes after the infusion, and also have emergency treatment available if required.
Danish: Lægerne kender til disse bivirkninger og vil holde øje med dig under infusionen og i mindst 30 minutter efter infusionen er afsluttet, og de har også en akut nødhjælpsbehandling klar, hvis det skulle blive nødvendigt.
English: C-labelled product to lactating rats 10-11 days post-parturition, which peaked at 8 to 24 hours post-administration.
Danish: mærkede produkt til diegivende rotter 10-11 dage post partum, som toppede 8-24 timer efter administrationen.
English: The Cmax and time of maximum concentration (tmax) were 206 mcg/ml and 0.32 hr, respectively.
Danish: Cmax og tid til maksimal koncentration (tmax) var henholdsvis 206 mcg/ml og 0,32 t.
English: Black to reddish brown solution Osmolality: 270-330 mosm/kg pH: 6.5 to 8.0
Danish: Sort til rødlig brun opløsning Osmolalitet: 270-330 mosm/kg pH: 6,5 til 8,0
English: Studies 1 and 2 enrolled patients with non-dialysis dependent CKD and Study 3 enrolled patients who were undergoing haemodialysis.
Danish: Studie 1 og 2 inkluderede patienter med ikke-dialysekrævende CKD, og Studie 3 inkluderede patienter, der gennemgik hæmodialyse.
English: Women of childbearing potential and pregnancy
Danish: Kvinder i den fertile alder og graviditet
English: Rate of infusion had no influence on Rienso PK parameters.
Danish: Infusionshastigheden havde ingen indflydelse på Riensos PK-parametre.
English: Study 1 Non-dialysis CKD
Danish: Studie 1 Ikke-dialyse CKD
English: In the Rienso and oral iron groups, 36% and 43% of patients, respectively, were receiving ESAs at Baseline.
Danish: I grupperne med Rienso og oralt jern fik henholdsvis 36 % og 43 % af patienterne ESAs ved baseline.
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.
Danish: Svær hypersensitivitet eller hypotensive reaktioner er ikke almindelige (mindre end 1 tilfælde per 100 patienter) og blev indberettet hos 0,2 % (3/1.562) af forsøgspersonerne med CKD, som fik Rienso under de kliniske studier.
English: • Any unused product or waste material should be disposed of in accordance with local
Danish: • Ikke anvendt lægemiddel samt affald herfra skal bortskaffes i henhold til lokale retningslinjer.
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.
Danish: I betragtning af det kumulative antal indberettede tilfælde af overfølsomhedsreaktioner (alvorlige, ikke alvorlige), herunder 35 dødelige tilfælde, overvejede PRAC nye yderligere risikominimeringsforanstaltninger ud over dem, der allerede er implementeret som en del af den foregående PSUR og anbefalede, at der tilføjes en advarsel om den resulterende sværhed af overfølsomhedsreaktionerne hos patienter over 65 år med co-morbiditeter i punkt 4.4 i produktresuméet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label (1, 2, 6 or 10 vial pack)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Etiket på æsken (pakning med 1, 2, 6 eller 10 hætteglas)
English: Rienso can affect the interpretation of your blood iron test results.
Danish: Rienso kan påvirke fortolkningen af blodprøver for jern.
English: Rienso is supplied in glass vials containing 17 ml.
Danish: Rienso leveres i hætteglas af glas med 17 ml.
English: COMMON (≥ 1/100 to
Danish: ALMINDELIG (≥1/100 til
English: Study 2 Non-dialysis CKD
Danish: Studie 2 Ikke-dialyse CKD
English: Takeda Pharma Ges.m.b.H.
Danish: Österreich Takeda Pharma Ges.m.b.H.