FrancophonIA/ELRC3.0 huggingface dataset:
English: Among 20 patients who presented a reaction of grade IV, six (6) patients died.
Danish: At de 20 patienter der fik en grad IV-reaktion, døde seks (6).
English: According to the MAH, of 9 fatal cases of hypersensitivity reactions reported, six (1.9%, 6/317) were considered to be related.
Danish: Ifølge indehaveren af markedsføringstilladelsen blev der indberettet 9 dødelige tilfælde af hypersensitivitetsreaktion, af hvilke 6 (1,9 %, 6/317) blev anset for at have sammenhæng med behandlingen.
English: Since the time of authorisation until 29 February 2012, a total of 587 case reports have been received yielding an ADR reporting rate of 0.003 % (which corresponds to 1093 case reports for 100,000 patients-days).
Danish: Fra godkendelsestidspunktet frem til den 29. februar 2012 er der i alt modtaget 587 indberetningsrapporter, svarende til en indberetningsfrekvens af bivirkninger på 0,003 % (eller 1 093 case-rapporter pr. 100 000 patientdage).
English: Other control patients have been grouped into those receiving other IV iron preparations (N=3,364), oral iron (N=887), placebo (N=256) or standard medical care [(SMC), N=159].
Danish: De øvrige kontrolpatienter fordeler sig på dem, der fik andre intravenøst administrerede jernholdige lægemidler(N=3 364), oralt jern (N=887), placebo (N=256) eller standardbehandling [N=159].
English: This cytotoxicity is proper to various iron complexes nevertheless the effect is related to the stability of the complex and therefore of the
Danish: Cytotoksiciteten er en egenskab hos en række jernkomplekser, men effekten hænger ikke desto mindre sammen med kompleksets stabilitet og dermed af det kulhydrat, der er anvendt til coating.
English: Three patients experienced ADRs of potential allergic nature in completed studies.
Danish: 3 patienter fik bivirkninger af potentielt allergisk art i de afsluttede undersøgelser.
English: Two ADRs have been included in the analysis of allergic reactions according to the Ring and Messmer classification from the analysed or completed studies.
Danish: To bivirkninger indgår i analysen af de allergiske reaktioner, der er klassificeret efter Ring og Messmer i de analyserede eller afsluttede undersøgelser.
English: Of these all patients recovered.
Danish: Alle disse patienter blev restitueret.
English: Sodium ferric gluconate was mainly prescribed for the treatment of iron deficiency anaemia and rarely for the treatment of anaemia in pregnancy.
Danish: Natriumferrigluconat blev hovedsagelig ordineret til behandling af jernmangelanæmi, sjældent til behandling af anæmi under graviditet.
English: Analysis on the severity of the hypersensitivity post marketing cases showed 33 cases of the 178 serious cases required hospitalization, 31 cases of the 178 serious cases were of a life-threatening nature, from which 6 patients presented with a history of allergy.
Danish: Analyse af sværheden af hypersensitivitetstilfælde efter markedsføring viste, at af de 178 alvorlige tilfælde var 33 indlæggelseskrævende, 31 var livstruende, og 6 heraf havde allergi i anamnesen.
English: Regarding allergic reactions, a total of 846 cases / 1524 ADRs/AEs were identified of which approximately half cases were serious and half were non-serious.
Danish: Af allergiske reaktioner blev der fundet i alt 846 tilfælde / 1 524 bivirkninger, hvoraf ca. halvdelen var alvorlige og halvdelen ikke-alvorlige.
English: A fatal case was also reported.
Danish: Der blev desuden indberettet ét tilfælde med dødelig udgang.
English: Some studies were iron sucrose only, some studies included a placebo or standard medical care arm, and some studies had another active substance as comparator.
Danish: I nogle undersøgelser anvendtes kun jernsukrose, i andre indgik en placebo- eller standardbehandlingsarm, og i endnu andre undersøgelser var der et andet aktivt sammenligningsstof.
English: As data from the post marketing reporting showed that a successful test dose may give false assurance to the professionals dealing with the product administration, no test dose should be applied.
Danish: Indberetningerne efter markedsføring viste, at en vellykket testdosis kan medføre falsk tryghed hos de sundhedspersoner, der er involveret i administration af produktet; der bør derfor ikke gives en testdosis.
English: According to this definition Grade I show skin symptoms and or mild fever reaction; Grade II show measurable symptoms, but not life threatening, cardiovascular reaction (tachycardia, hypotension), gastrointestinal disturbance (nausea) and respiratory; Grade III symptoms show shock, life threatening spams of smooth muscles (bronchi, uterus); and Grade IV show cardiac and/or respiratory arrest.
Danish: Efter denne definition ses ved grad I hudsymptomer og/eller let febril reaktion, ved grad II målelige, men ikke livstruende symptomer, kardiovaskulære reaktioner (takykardi, hypotension), gastrointestinale forstyrrelser (kvalme) og påvirkning af respirationen, ved grad III-chok og livstruende spasmer af glatmuskulatur (bronkier, uterus), og ved grad IV hjerteog/eller respirationsstop.
English: However, no skin reactions were seen when ferric carboxymaltose or iron sucrose was administered.
Danish: Der sås imidlertid ingen hudreaktioner ved administration af ferricarboxymaltose eller jernsukrose.
English: Iron(III)-hydroxide dextran complex
Danish: Jern(III)-hydroxid-dextrankompleks
English: One of the ways to classify the hypersensitivity reactions is according to Ring and Messmer1 definition.
Danish: Hypersensitivitetsreaktioner kan klassificeres i henhold til Ring og Messmers 1 definition.
English: Patients should be closely monitored for signs of hypersensitivity during and for at least 30 minutes after each administration of an intravenous iron product.
Danish: Patienterne skal overvåges tæt for tegn på hypersensitivitet under og mindst 30 minutter efter hver administration af et intravenøst administreret jernprodukt,
English: In the pivotal controlled study a total of 88 patients received sodium ferric gluconate.
Danish: I den kontrollerede hovedundersøgelser fik i alt 88 patienter natriumferrigluconat.
English: According to the Ring and Messmer classification reports twenty patients recovered without sequelae and one case (Grade I, 1 patient) was ongoing at time of last follow-up.
Danish: I henhold til den angivne Ring og Messmer-klassifikation blev 20 patienter restitueret uden sequelae, mens ét tilfælde (grad I, 1 patient) var uafsluttet på sidste opfølgningstidspunkt.
English: Close monitoring for signs of hypersensitivity during and for at least 30 minutes after each administration of an intravenous iron product is also recommended.
Danish: Ligeledes anbefales tæt overvågning for tegn på hypersensitivitet under og mindst 30 minutter efter hver administration af et intravenøst jernprodukt.
English: The iron complexes involved in this procedure are iron gluconate (sodium ferric gluconate), iron sucrose, iron dextran, iron carboxymaltose, and iron (III) isomaltoside 1000.
Danish: Jernkomplekserne omfattet af denne procedure er jerngluconat (natriumferrigluconat), jernsukrose, jerndextran, jerncarboxymaltose og jern(III)-isomaltosid 1000.
English: The MAH reported that 25 events were related to ferrix carboxymaltose (20 grade I, 2 grade II, 2 grade III and 1 grade IV), 2 events were unlikely related to ferrix carboxymaltose (1 grade II and 1 grade IV), 9 events were not related to ferrix carboxymaltose (6 grade I, 1 grade II and 2 grade III).
Danish: Indehaveren af markedsføringstilladelsen oplyste, at 25 af hændelserne havde sammenhæng med jerncarboxymaltose (20 af grad I, 2 af grad II, 2 af grad III og 1 af grad IV), 2 af hændelserne antoges ikke at have sandsynlig sammenhæng med jerncarboxymaltose (1 af grad II og 1 af grad IV), mens 9 af hændelserne var uden sammenhæng med jerncarboxymaltose (6 af grad I, 1 af grad II og 2 af grad III).
English: This reaction occurred in a patient with a history of multiple drug allergies including anaphylaxis to iron dextran.
Danish: Denne reaktion optrådte hos en patient med multiple lægemiddelallergier i anamnesen, herunder anafylaksi over for jerndextran.
English: The CHMP endorsed a Direct healthcare professional communication (DHPC), to communicate the outcome of the present review and to communicate to the healthcare professionals the updated method of administration for these products in an environment where trained staff and facilities for resuscitation exist and to highlight the risk of the hypersensitivity reactions.
Danish: CHMP godkendte en direkte meddelelse til fagfolk i sundhedssektoren (DHPC), som formidler resultatet af denne gennemgang og den opdaterede administrationsmetode for produkterne i et miljø med uddannet personale og genoplivningsudstyr, som også fremhæver risikoen for hypersensitivitetsreaktioner.
English: Only 1 patient experienced an aggravation of symptoms at the sodium ferric gluconate re-introduction: minor skin reaction at infusion site then hypotension, syncope, nausea and vomiting at the 2nd administration.
Danish: Kun 1 patient fik forværrede symptomer ved reintroduktion af natriumferrigluconat: en mindre hudreaktion på infusionsstedet efterfulgt af hypotension, synkope, kvalme og opkastning ved den anden administration.
English: However, due to very limited exposure in utero to sodium ferric gluconate the risk for neonates of developing any abnormality seems unlikely.
Danish: På grund af den meget begrænsede eksponering in utero for natriumferrigluconat er der dog næppe risiko for abnormiteter hos nyfødte.
English: Nevertheless, there was one grade IV (cardiac arrest) reported in Fishbane and colleagues (1996) publication and a total of fifteen hypersensitivity (7.3%) mainly grade II-III, reported in HD population (Haddad et al, 2009), all occurring during the test dose.
Danish: Der var dog et tilfælde af grad IV (hjertestop), beskrevet i en artikel af Fishbane et al. (1996), og i hæmodialysepopulationen blev der i alt beskrevet 15 tilfælde af hypersensitivitet (7,3 %), hovedsagelig af grad II-III, (Haddad et al, 2009), som alle indtrådte under administration af testdosen.
English: According to the Ring & Messmer algorithm, 15 non-serious cases were all coded as either Grade I or II cases.
Danish: I henhold til Ring & Messmer-algoritmen blev 15 ikke-alvorlige tilfælde alle kodet enten som grad I eller II.
English: Furthermore the CHMP agreed on other changes to the product information, additional pharmacovigilance activities and risk minimisation measures to address the risk of hypersensitivity events to all patients including administration in pregnancy.
Danish: CHMP vedtog desuden andre ændringer af produktinformationen, supplerende lægemiddelovervågning og risikominimeringsforanstaltninger over for hypersensitivitetshændelser hos alle patienter, herunder administration under graviditet.
English: All cases within this SOC have been classified according to the Ring and Messmer classification.
Danish: Alle tilfælde i denne systemorganklasse er blevet klassificeret i henhold til Ring og Messmer.
English: The majority of hypersensitivity associated events (15.1%) occurred between 1 hour and 24 hours after treatment with iron sucrose, closely followed by hypersensitivity associated events which occurred between 5 and 30 minutes (13.9%)
Danish: Størstedelen af de hypersensitivitetsrelaterede hændelser (15,1 %) indtrådte mellem 1 time og 24 timer efter behandlingen med jernsukrose, tæt efterfulgt af hypersensitivitetsrelaterede hændelser, der fandt sted efter mellem 5 og 30 minutter (13,9 %).
English: Of these, 3 were classified as anaphylactoid reactions.
Danish: Heraf blev 3 klassificeret som anafylaktoide reaktioner.
English: As of 29 February 2012 a total of 26 case reports regarding hypersensitivity have been received yielding an ADR reporting rate of 0.02 %.
Danish: Pr. 29. februar 2012 var der modtaget i alt 26 rapporter om hypersensitivitet, svarende til en bivirkningsindberetningsfrekvens på 0,02 %.
English: In most publications the majority of anaphylactoid reactions reported with LMWID were classified as grade I-II of severity according to Ring and Messmer classification.
Danish: I de fleste publikationer blev størstedelen af de anafylaktoide reaktioner, der blev beskrevet med LMWID, klassificeret som Ring og Messmer sværhedsgrad I-II.
English: The MAHs were requested by the CHMP to provide a detailed analysis classified according to Ring and Messmer for the purpose of the review of the risk of allergic reactions.
Danish: Indehaverne af markedsføringstilladelse blev af CHMP anmodet om at give en detaljeret analyse, klassificeret efter Ring og Messmer, til brug ved gennemgangen af risikoen for allergiske reaktioner.
English: Between the 20 patients who presented an anaphylactic reaction grade IV, 35% (7/20) patients had a medical history of hypersensitivity reactions.
Danish: Af de 20 patienter, der fik en anafylaktisk reaktion af grad IV, havde 35 % (7/20) hypersensitivitetsreaktioner i anamnesen.
English: A total of 168 cases were reported with a primary event within the System Organ Class (SOC) of immune system disorders (28.6%) including 147 serious.
Danish: Der blev i alt beskrevet 168 tilfælde (28,6 %), hvor primærhændelsen var i systemorganklasse immunsystemet; heraf var 147 alvorlige.
English: One patient with previous allergies and severe complications NOS after administration of dextran, received an overdose of sodium ferric gluconate and died from an acute myocardial infarction the day of sodium ferric gluconate infusion.
Danish: Én patient med tidligere allergier og ikke nærmere beskrevne svære komplikationer efter administration af dextran døde efter en overdosis af natriumferrigluconat som følge af akut myokardieinfarkt samme dag som infusionen af natriumferrigluconat.
English: A total of 317 cases of hypersensitivity were identified from the MAH database, which occurred in 13,824,369 patient years (cut-off date 31 December 2011).
Danish: I markedsføringstilladelsesindehaverens database blev der i alt fundet 317 tilfælde af hypersensitivitet, der fandt sted ved en eksponering på 13 824 369 patientår (skæringsdato 31. december 2011).
English: The latter should also be included in the risk management plan, highlighting the risks and warnings of hypersensitivity reactions.
Danish: Dette oplysningsmateriale skal indgå i risikostyringsplanen og skal fremhæve risici og advarsler i forbindelse med hypersensitivitetsreaktioner.
English: Only a few preclinical studies with low molecular weight iron dextrans (LMWID), iron(III) isomaltoside 1000 have been carried out and only studies with safety findings relevant to immunogenicity were referenced in the data submission by the MAHs.
Danish: Der er kun udført få prækliniske undersøgelser med lavmolekylære jerndextraner (LMWID) og jern(III)-isomaltosid 1000, og indehaverne af markedsføringstilladelse indsendte kun data fra undersøgelser med sikkerhedsmæssige resultater af relevans for immunogeniciteten.
English: The majority of hypersensitivity associated AEs (26.1%) occurred between 5 to 30 minutes after treatment with ferric carboxymaltose, closely followed by hypersensitivity associated AEs which occurred during the infusion/injection (15.9%).
Danish: Størstedelen af de hypersensitivitetsrelaterede bivirkninger (26,1 %) indtrådte 5-30 minutter efter behandlingen med ferricarboxymaltose, tæt efterfulgt af hypersensitivitetsrelaterede bivirkninger, der indtrådte under infusion/injektion (15,9 %).
English: The CHMP also agreed that the MAHs should submit annual cumulative reviews of hypersensitivity case reports, all fatal cases and all pregnancy cases, together with usage data, using same data lock point, same exposure definition, same event definition and the severity classification according to Ring and Messmer classification.
Danish: CHMP vedtog, at indehaverne af markedsføringstilladelse desuden årligt skal indsende samlede oversigter over indberetningsrapporter om hypersensitivitet, alle dødeligt tilfælde, alle graviditeter samt data om lægemiddelanvendelse, og at dette skal ske med samme skæringstidspunkt, samme definition af eksponering, samme definition af hændelse (bivirkning) og med sværhed klassificeret efter Ring og Messmer.
English: Data provided regarding safety in pregnancy and intestinal absorption disorder was very limited.
Danish: Der forelå meget begrænsede oplysninger om sikkerheden ved graviditet og ved forstyrrelser i tarmabsorptionen.
English: Of note, hypotension, nausea, vomiting and cramps are often symptoms associated with haemodialysis.
Danish: Det må bemærkes, at hypotension, kvalme, opkastning og kramper ofte forekommer i forbindelse med hæmodialyse.
English: In 8 cases of the total 51 life-threatening cases (15.7%; 8/51 cases, one graded as Grade IV), the patient presented with a history of allergy.
Danish: Allergi i anamnesen forekom i 8 af de i alt 51 livstruende tilfælde (15,7 %; 8/51 tilfælde, det ene klassificeret som grad IV).
English: Six cases (4%) were classified as grade IV (2 reported anaphylactic shock leading to a fatal outcome and 4 anaphylactic shock leading to cardiac arrest (all patients made full recovery).
Danish: Seks tilfælde (4 %) blev klassificeret som grad IV (2 med anafylaktisk chok med dødeligt udfald, og 4 med anafylaktisk chok, der medførte hjertestop, men med fuld restitution).
English: According to the Ring and Messmer classification, three cases were classified as grade II anaphylactoid reactions and one case as grade III.
Danish: I henhold til Ring og Messmer-klassifikationen blev tre tilfælde klassificeret som anafylaktoide reaktioner af grad II, og et tilfælde som grad III.
English: In 2011 the French medicines agency (ANSM) had concerns with regards to the risk of hypersensitivity reactions of intravenous iron containing products indicated in iron deficiency situations when the oral route is insufficient or poorly tolerated especially in chronic kidney disease (CKD) patients (haemodialysis), but also in pre- or post-operative situations, or in case of intestinal absorption disorders.
Danish: I 2011 blev den franske lægemiddelstyrelse (ANSM) betænkelig ved risikoen for hypersensitivitetsreaktioner over for intravenøst administrerede jernholdige lægemidler, der er indiceret ved jernmangel, når oral administration er utilstrækkelig eller tolereres dårligt, navnlig hos hæmodialysepatienter med kronisk nyresygdom, men også præ- eller postoperativt og ved forstyrrelser i absorptionen fra tarmen.
English: A higher incidence of total adverse events (AEs) per patient and exposure within LMWID compared to iron sucrose group was identified but no difference between iron sucrose and iron gluconate (Ganguli et al 2008) in CKD population was observed.
Danish: Der iagttoges højere total bivirkningsforekomst per patient og eksponering i LMWID end i jernsukrosegruppen, men ingen forskel mellem jernsukrose og jerngluconat i populationen med kronisk nyresygdom (Ganguli et al 2008).
English: One pivotal and one supportive controlled studies were conducted in adults to assess the efficacy and safety of sodium ferric gluconate as first line treatment for iron deficiency anaemia in renal haemodialysis patients on supplemental recombinant human erythropoietin.
Danish: Der blev udført én hovedundersøgelse og én støttende kontrolleret undersøgelse hos voksne til vurdering af virkningen og sikkerheden af natriumferrigluconat som førstevalgsbehandling af jernmangelanæmi hos patienter, der er i renal hæmodialyse og får tilskud af rekombinant humant erythropoietin.
English: Patients with known allergies and with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) may enhance their risk when given these products as their condition may worsen unless it is deemed that the benefit outweighs the risks for these patients.
Danish: For patienter med kendt allergi og immunbetingede eller inflammatoriske sygdomme (f.eks. systemisk lupus erythematosus, og reumatoid arthritis) kan disse produkter øge risikoen for forværring af sygdommen og bør kun gives, når fordelene skønnes at opveje risiciene.
English: For iron gluconate (sodium ferric gluconate) an overview of the toxicology program performed between 1970's and 1996 to support the registration of sodium ferric gluconate complex was submitted.
Danish: For jerngluconat (natriumferrigluconat) blev der forelagt en oversigt over det toksikologiprogram, der var gennemført fra 1970'erne og indtil 1996 som dokumentation til registreringsansøgningen for natriumferrigluconatkomplekset.
English: Thus, four cases of allergic reactions possibly related to iron (III) isomaltoside 1000 have been found in the trials.
Danish: Der er således fundet fire tilfælde af allergiske reaktioner med mulig sammenhæng med jern(III)-isomaltosid 1000 i undersøgelserne.
English: As part of the risk minimisation measures the CHMP considered there was a need to ensure that all relevant information for the safe use of these products should be applied across authorised products and therefore agreed on the wording for all relevant sections dealing with the risk of hypersensitivity reactions including the sections on pregnancy.
Danish: Foranstaltninger til risikominimering og andre lægemiddelovervågningsaktiviteter Som led i risikominimeringsforanstaltningerne fandt CHMP, at der bør gøres brug af al relevant information om sikker anvendelse af disse produkter for alle godkendte produkter, og vedtog derfor en ordlyd til alle relevante afsnit om risikoen for hypersensitivitetsreaktioner, herunder afsnittene om graviditet.
English: The CHMP endorsed a Dear healthcare professional communication (DHPC), to communicate the outcome of the present review.
Danish: CHMP bestemte, at der skal udsendes en direkte meddelelse til fagfolk i sundhedssektoren (DHPC) om resultatet af denne gennemgang.
English: Grounds for the variation to the terms of the marketing authorisation
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelsen Ud fra følgende betragtninger:
English: Only two MAH studies have been conducted with low molecular weight iron (III)-hydroxide dextran complex.
Danish: Indehaverne af markedsføringstilladelse har kun udført to undersøgelser med lavmolekylært jern(III)hydroxid-dextrankompleks.
English: The main safety data which were used in the CHMP assessment and conclusions were post-marketing data for all complexes.
Danish: Det vigtigste grundlag for CHMP's vurdering og konklusioner var sikkerhedsdata efter markedsføring for alle jernkomplekserne.
English: The Committee in addition stressed that the intravenous iron products should only be administered when staff trained to evaluate and manage anaphylactic/anaphylactoid reactions as well as resuscitation facilities are immediately available.
Danish: • udvalget understregede desuden, at intravenøse, jernholdige lægemidler kun bør administreres, når der på behandlingsstedet umiddelbart forefindes personale, som er oplært i at vurdere og håndtere anafylaktiske/anafylaktoide reaktioner, samt genoplivningsudstyr.
English: There are only three completed studies involving iron (III) isomaltoside 1000 and eleven are still ongoing.
Danish: Kun tre undersøgelser med jern(III)-isomaltosid 1000 er afsluttet, mens 11 undersøgelser stadig pågår.
English: A systematic review of the relevant published literature has been performed and randomised clinical study and other study designs including uncontrolled retrospective and prospective studies have been included if they reported on ADRs associated with the use of low molecular weight iron dextran (LMWID) complex.
Danish: Der er udført en systematisk gennemgang af den relevante publicerede litteratur, der indbefattede alle randomiserede kliniske undersøgelser og andre undersøgelsesdesign, herunder ukontrollerede, retrospektive og prospektive undersøgelser, som beskrev uønskede lægemiddelreaktioner i forbindelse med anvendelse af lavmolekylært jerndextran- (LMWID-) kompleks.