FrancophonIA/ELRC3.0 huggingface dataset:
English: During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Danish: På sit møde i juli 2008 var CHMP på baggrund af de samlede fremlagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at forslaget om harmonisering af produktresumé, etikettering og indlægsseddel var acceptabelt, og at ændringerne burde foretages.
English: On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal Consta and associated names.
Danish: Den 24. juli 2007 indbragte Europa-Kommissionen en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, med henblik på harmonisering af de nationalt godkendte produktresuméer, indlægsseddel og etikettering for lægemidlet Risperdal Consta og tilknyttede navne.
English: The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal Consta and associated names.
Danish: CHMP afgav en positiv udtalelse den 24. juli 2008, hvori udvalget anbefalede harmonisering af produktresumé, etikettering og indlægsseddel for Risperdal Consta og tilknyttede navne.
English: The majority of patients were female.
Danish: Størstedelen af patienterne var kvindelige.
English: Most of them received only one infusion.
Danish: Størstedelen fik kun én infusion.
English: These reactions may be damaging, uncomfortable, or occasionally fatal.
Danish: Disse reaktioner kan være skadelige og ubehagelige eller undertiden dødelige.
English: In about 80% of the cases, the outcome of pregnancy was unknown.
Danish: I ca. 80 % af tilfældene var resultatet af graviditeten ukendt.
English: The majority of studies were retrospective.
Danish: Størstedelen af undersøgelserne var retrospektive.
English: Published literature was also provided.
Danish: Der blev derudover forelagt publiceret litteratur.
English: This recommendation was also advised by the PRAC during the consultation requested by the CHMP.
Danish: Denne anbefaling blev også givet af PRAC under det samråd, som CHMP anmodede om.
English: Anti-allergic treatment was reported for 94/168 cases.
Danish: Der blev angivet antiallergisk behandling i 94/168 tilfælde.
English: Instead caution should be exercised in each iron administration even in the cases of repeated administrations.
Danish: I stedet bør der udvises forsigtighed ved hver administration af jern, selv ved gentagne administrationer.
English: Twenty-two clinical studies were submitted.
Danish: Der blev forelagt 22 kliniske undersøgelser.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for intravenous iron containing medicinal products.
Danish: • udvalget fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for intravenøst administrerede jernholdige lægemidler,
English: Among all studies provided, only one life-threatening reaction was reported (Michael, et al 2002).
Danish: I alle forelagte undersøgelser blev der kun beskrevet én livstruende reaktion (Michael, et al 2002).
English: Overall summary of the scientific evaluation of intravenous iron containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af intravenøst administrerede jernholdige lægemidler (se bilag I).
English: When outcome is known, most patients recovered without sequelae (94.8%).
Danish: Hvor udfaldet blev oplyst, blev de fleste patienter restitueret uden sequelae (94,8 %).
English: The following analyses were performed on spontaneous or solicited cases, medically confirmed or not, recorded until 15 December 2011.
Danish: Følgende analyser blev udført på spontane eller uopfordrede indberetninger af lægeligt bekræftede eller ikke lægeligt bekræftede tilfælde, som blev registreret indtil den 15. december 2011.
English: In approximately 90% of the cases in which the time to onset was reported the reaction occurred within the first 10 minutes of administration, and in about one third it occurred during the test dose.
Danish: I ca. 90 % af de tilfælde, hvor tiden indtil reaktionens start blev angivet, indtrådte reaktionen inden for de første ti minutter efter administrationen, og i ca. en tredjedel af tilfældene indtrådte den under administration af testdosen.
English: The far majority of cases could not be assessed as potential serious allergic reactions.
Danish: Langt størstedelen af tilfældene kunne ikke vurderes som potentielle alvorlige allergiske reaktioner.
English: Of these, one was reported as non-serious and four as serious.
Danish: Heraf blev ét beskrevet som ikke alvorligt, og fire som alvorlige.
English: A total of 33 publications reporting on the safety of LMWID were identified.
Danish: Der blev fundet i alt 33 publikationer med resultater vedrørende sikkerheden af LMWID.
English: Thirty-two of 88 patients experienced a reaction at injection site.
Danish: 32 ud af 88 patienter fik en reaktion på injektionsstedet.
English: For one patient, the event of hypersensitivity occurred after the first and the second injection.
Danish: For én patients vedkommende optrådte hypersensitivitetshændelsen efter den første og den anden injektion.
English: Cytotoxicity is mediated throughout the formation of reactive oxygen species (ROS).
Danish: Cytotoksiciteten medieres af dannelse af reaktive oxygenforbindelser (ROS).
English: In summary, there is only very limited data on safety from clinical studies.
Danish: Sammenfattende kan der kun uddrages meget begrænsede sikkerhedsdata af de kliniske undersøgelser.
English: The test-dose does not seem to prevent the occurrence of severe reactions.
Danish: Denne testdosis synes ikke at forebygge optræden af svære reaktioner.
English: Predisposition to an allergy or known asthma may result in a more severe reaction.
Danish: Disposition for allergi eller kendt astma kan medføre en sværere reaktion.
English: In conclusion the post-marketing data are in accordance with the known safety profile of ferric carboxymaltose.
Danish: Som konklusion er data efter markedsføring i overensstemmelse med den kendte sikkerhedsprofil af jerncarboxymaltose.
English: A total of 236 cases of hypersensitivity reactions were reported (mainly grade I and II).
Danish: Der blev indberettet i alt 236 tilfælde af hypersensitivitetsreaktioner (hovedsagelig grad I og II).
English: All studies have been performed applying a protocol not including a test dose.
Danish: Alle undersøgelserne er udført i henhold til en protokol uden testdosis.
English: In about one third of the total cases (223/846), the patients recovered after drug withdrawal.
Danish: I ca. 1/3 af det samlede antal tilfælde (223/846), blev patienterne restitueret efter seponering af lægemidlet.
English: Cytotoxicity of various iron complexes has been documented in the literature.
Danish: Cytotoksiciteten af forskellige jernkomplekser er dokumenteret i litteraturen.
English: For some cases (108 out of 168) the time-to-onset of the reaction was reported.
Danish: I nogle tilfælde (108 ud af 168) blev tiden indtil reaktionens start angivet.
English: In addition the CHMP stressed that these products should not be given to pregnant women in the first trimester of pregnancy; treatment should be confined to second or third trimester, if the benefit is clearly judged to outweigh the potential risks for both the mother and the foetus.
Danish: Desuden understregede CHMP, at disse produkter ikke bør gives til gravide kvinder i første trimester; behandlingen bør kun gives i andet eller tredje semester, og kun hvis fordelen skønnes klart at overstige de potentielle risici for både moderen og fostret,
English: It might be of interest to note, that these patients had penicillin allergy and latex allergy, respectively.
Danish: Det er måske værd at bemærke, at disse patienter var allergiske over for henholdsvis penicillin og latex.
English: Within the on-going clinical studies only two serious adverse reactions have been reported.
Danish: I de igangværende kliniske undersøgelser er der kun indberettet to tilfælde af alvorlige bivirkninger.
English: As the conclusions of this assessment were mainly drawn from the post-marketing data, differentiation between these iron complexes in terms of hypersensitivity reactions could not be identified.
Danish: Da konklusionerne i denne vurdering hovedsagelig blev baseret på data efter markedsføring, var det ikke muligt at skelne mellem disse jernkomplekser hvad angår hypersensitivitetsreaktioner.
English: In only one case, the onset was reported as a late-occurring event (onset after one day).
Danish: Kun i et enkelt tilfælde blev reaktionen angivet som en sen begivenhed (efter én dag).
English: Hypersensitivity (also called allergic reactions) refers to undesirable reactions produced by the normal immune system, including allergies and autoimmunity.
Danish: Ved hypersensitivitet (også kaldet allergiske reaktioner) forstås uønskede reaktioner fra det normale immunsystem, herunder allergier og autoimmunitet.
English: The Committee concluded that there was need for further risk minimisation measures such as information to patients and healthcare professionals.
Danish: • udvalget konkluderede, at der behøves yderligere risikominimeringsforanstaltninger såsom information til patienter og sundhedspersoner.
English: Some of the assessed parenteral iron containing products have a recommendation for a test dose to be administered prior to the final administration.
Danish: For nogle af de vurderede parenterale jernholdige produkter anbefales administration af en testdosis før den endelige administration.
English: Over all studies, 36 hypersensitivity events occurring in 35 patients were reported.
Danish: I alle undersøgelserne indberettedes 36 hypersensitivitetshændelser hos 35 patienter.
English: Ferric carboxymaltose
Danish: Ferricarboxymaltose
English: 19 pregnant women presented at least one anaphylactic reaction.
Danish: Hos 19 gravide kvinder blev der konstateret mindst én anafylaktisk reaktion.
English: The CHMP discussed the potential that patients with allergies (notably type 1-allergies) may have an increased risk of serious allergic reactions to intravenous iron.
Danish: CHMP drøftede potentialet for, at patienter med allergier (navnlig type 1-allergier) kan have forhøjet risiko for alvorlige allergiske reaktioner over for intravenøst jern.
English: These 19 patients recovered at sodium ferric gluconate withdrawal with or without corrective treatment.
Danish: Disse 19 patienter blev restitueret ved seponering af natriumferrigluconat med eller uden korrigerende behandling.
English: For reports classified as grade III, the most commonly reported term was “anaphylactic shock” and the outcome of these cases was either recovered, not recovered (1 case only) or unknown (8 cases).
Danish: For tilfælde klassificeret som grad III var den oftest angivne betegnelse “anafylaktisk chok”, og udfaldet af disse tilfælde var enten restitueret, ikke restitueret (kun ét tilfælde) eller ukendt (8 tilfælde).
English: When classifying all cases that were not reported as immune reactions, according to CTCAE approximately 20% were classified as grade III.
Danish: Når alle tilfælde, der ikke var beskrevet som immunreaktioner, blev klassificeret i henhold til CTCAE, blev ca. 20 % klassificeret som grad III.
English: Two of these 3 anaphylactoid reactions occurred in patients with Crohn's disease.
Danish: 2 af disse 3 anafylaktoide reaktioner forekom hos patienter med Crohns sygdom.
English: In conclusion, regarding post-marketing data, 317 cases of hypersensitivity were reported (frequency rate 0.0022%).
Danish: Som konklusion blev der efter markedsføring indberettet 317 tilfælde af hypersensitivitet (indberetningsfrekvens 0,0022 %).
English: In two cases, no symptoms were reported and it was not reported whether treatment of the reaction was provided nor was the time to onset other than the day of the event reported, making it difficult to classify these events.
Danish: I to tilfælde blev der ikke beskrevet symptomer, og det blev ikke oplyst, om der blev givet nogen behandling for reaktionen, eller hvor lang tid der gik indtil reaktionens start ud over indberetningsdatoen, hvilket gjorde det vanskeligt at klassificere disse hændelser.
English: One of these cases was an anaphylactoid reaction, and another was a probable serious allergic reaction.
Danish: Et af disse tilfælde var en anafylaktoid reaktion, og et andet var en formodet alvorlig allergisk reaktion.
English: In conclusion the CHMP recommended that no test dose is administered for any of the intravenous containing iron products.
Danish: Som konklusion anbefalede CHMP, at der ikke gives nogen testdosis af nogen af de intravenøst administrerede jernholdige produkter.
English: Further, a test-dose might give the prescriber a feeling of false assurance that an allergic reaction is unlikely to happen.
Danish: Desuden kan en testdosis give den ordinerende læge en fejlagtig overbevisning om, at en allergisk reaktion er usandsynlig.
English: The CHMP concluded that the information on test dose is not appropriate as it may give false reassurance to the healthcare professionals.
Danish: CHMP konkluderede, at oplysningen om testdosis ikke er hensigtsmæssig, da den kan give sundhedspersoner en falsk sikkerhedsfølelse.
English: A total of 1649 cases including 546 serious and 1103 non-serious cases corresponding to 6179 ADRs were recorded.
Danish: I alt blev der registreret 1 649 tilfælde, heraf 546 alvorlige og 1 103 ikke-alvorlige, svarende til 6 179 bivirkninger.
English: Six cases were classified as grade V and all led to a fatal outcome due to cardiac arrest, hypotension, or circulatory failure.
Danish: Seks tilfælde blevet klassificeret som grad V og fik alle dødeligt udfald som følge af hjertestop, hypotension eller kredsløbssvigt.
English: In later stages of pregnancy the intravenous iron preparations may be given but after careful consideration of the risks involved for the mother and foetus.
Danish: I de senere stadier af graviditeten kan der gives intravenøst administrerede jernpræparater, men kun under nøje hensyn til risiciene for moderen og fosteret.
English: This is out of around 260 patients being included in clinical studies regarding iron (III) isomaltoside 1000 (studies that also assessed safety parameters).
Danish: Dette er ud af ca. 260 patienter, der var inkluderet i kliniske undersøgelser vedrørende jern(III)-isomaltosid 1000 (undersøgelser, som også vurderede sikkerhedsparametre).
English: All five patients made full recovery.
Danish: Alle 5 patienter blev fuldt restitueret.
English: Three patients experienced allergic reactions leading to product discontinuation.
Danish: 3 patienter fik allergiske reaktioner, der medførte seponering af produktet.
English: All administrations of these iron complexes should be given in an environment with staff able to recognise and treat hypersensitivity reactions and where resuscitation facilities are available.
Danish: Alle administrationer af disse jernkomplekser skal gives i et miljø, hvor der er personale til stede, som kan genkende og behandle hypersensitivitetsreaktioner, og hvor der forefindes genoplivningsudstyr.
English: The majority of cases were classified as grade III (53%) followed by grade II (32%).
Danish: Grad III-tilfælde udgjorde størstedelen (53 %), efterfulgt af grad II (32 %).
English: In these patients, intravenous iron products should only be used if the benefit is clearly judged to outweigh the potential risk.
Danish: Hos sådanne patienter bør intravenøst administrerede jernholdige lægemidler kun anvendes, hvis fordelen skønnes klart at overstige den potentielle risiko,
English: Iron(III) isomaltoside 1000
Danish: Jern(III)-isomaltosid 1000
English: All these patients recovered after product withdrawal.
Danish: Alle disse patienter blev restitueret efter seponering af produktet.
English: In the 3% of cases where sodium ferric gluconate was re-administered, the patients experienced the same type of ADRs, mainly allergic reactions without aggravation of the symptoms.
Danish: I de 3 % af tilfældene, hvor natriumferrigluconat blev readministreret, fik patienterne bivirkninger af samme art, hovedsagelig allergiske reaktioner uden forværring af symptomerne.
English: The majority of cases were reported as serious and five cases were reported with a primary event within the immune system disorders.
Danish: Størstedelen af tilfældene blev beskrevet som alvorlige, og fem af tilfældene blev beskrevet som en primær hændelse vedrørende immunsystemet.
English: One study showed that slow administration of sodium ferric gluconate resulted in less allergic reactions than if this was done during a shorter period of time.
Danish: Én undersøgelse viste, at langsom administration af natriumferrigluconat medførte færre allergiske reaktioner end administration over kortere tid.
English: In view of the above, on 7 December 2011 France requested the CHMP under Article 31 of Directive 2001/83/EC to assess the above concerns regarding hypersensitivity and its impact on the benefit-risk balance for iron intravenous containing medicinal products, and to give its opinion on measures necessary to ensure the safe and effective use, and on whether the marketing authorisation for these products should be maintained, varied, suspended or withdrawn.
Danish: På denne baggrund anmodede Frankrig den 7. december 2011 i medfør af artikel 31 i direktiv 2001/83/EF CHMP om at vurdere de nævnte betænkeligheder ved hypersensitivitet og betydningen heraf for benefit/risk-forholdet for intravenøst administrerede jernholdige lægemidler, og at fremsætte en udtalelse om foranstaltninger, der er nødvendige for at garantere sikker og effektiv anvendelse, og om, hvorvidt markedsføringstilladelserne for disse produkter burde opretholdes, ændres, suspenderes eller inddrages.
English: All patients recovered from the hypersensitivity event.
Danish: Alle patienterne blev restitueret efter hypersensitivitetshændelsen.
English: The 6 serious cases were reported as 1 Grade I case, 2 Grade III cases and 3 Grade IV cases.
Danish: De 6 alvorlige tilfælde blev beskrevet som 1 tilfælde af grad I, 2 tilfælde af grad III og 3 af grad IV.
English: Among the 846 cases with allergic reaction, 55 patients (6.5%) received a dose-test of sodium ferric gluconate prior to the first IV infusion.
Danish: Af de 846 tilfælde med allergisk reaktion fik 55 patienter (6,5 %) en testdosis af natriumferrigluconat forud for den første intravenøse infusion.
English: The dose immediately prior to events, in both clinical trial database and post marketing safety database varies widely.
Danish: Dosis umiddelbart før hændelserne varierer stærkt, både i databasen over de kliniske undersøgelser og databasen over sikkerhed efter markedsføring.
English: This corresponds to a hypersensitivity events frequency rate of 0.060%, which is lower than the frequency rate found in clinical trials.
Danish: Dette svarer til en rate af hypersensitivitetshændelser på 0,060 %, hvilket er lavere end den, der fandtes i de kliniske undersøgelser.
English: Other groups of patients included home total parenteral nutrition, those unable to tolerate or respond to oral iron, children with inflammatory bowel disease (IBD), patients with cancer, and pregnant women.
Danish: Andre patientgrupper var patienter i total parenteral ernæring, patienter, der ikke tålte eller responderede på oralt jern, børn med inflammatorisk tarmsygdom, kræftpatienter og gravide kvinder.
English: A total of 34 grade III (14.4%) and 2 grade IV (0.8%) were reported.
Danish: Der blev indberettet 34 tilfælde af grad III (14,4 %) og 2 af grad IV (0,8 %).
English: No dose response or relationship to method of administration (undiluted bolus injection versus diluted infusion) was observed for hypersensitivity events.
Danish: Der blev ikke iagttaget dosisrespons eller sammenhæng med administrationsmetoden (ufortyndet bolusinjektion versus fortyndet infusion) for hypersensitivitetshændelserne.
English: Out of these 6 patients, 5 patients died from a non-allergic reaction a few days after the last injection (e.g. complications of amputation, septic shock, bronchopulmonary disease complication, rhabdomyolysis and pulmonary embolism).
Danish: Af disse 6 patienter døde de 5 af en ikkeallergisk reaktion få dage efter den sidste injektion (f.eks. komplikationer til amputation, septisk chok, bronkopulmonal sygdomskomplikation, rabdomyolyse og lungeemboli).
English: Different regimens were employed from 100 mg maintenance doses in HD to high accelerated total dose infusions (TDIs).
Danish: De anvendte regimer spændte fra vedligeholdelsesdoser på 100 mg hos hæmodialysepatienter til fremskyndet totaldosis-infusion af høje doser.
English: Until 31 December 2011, a total of 236 hypersensitivity associated cases were identified, for a total exposure of 393,160 patient-years.
Danish: Frem til den 31. december 2011 blev der konstateret 236 hypersensitivitetsrelaterede tilfælde ved en samlet eksponering på 393 160 patientår.
English: Over 8,000 patients have been included/treated across all arms in these clinical trials, of whom almost half (N=4,048) received iron sucrose either as the test product or as the reference (comparator) therapy.
Danish: I alle arme i disse undersøgelser blev der tilsammen inkluderet/behandlet over 8 000 patienter, hvoraf næsten halvdelen (N=4 048) fik jernsukrose, enten som testprodukt eller som reference- (sammenligningsbehandling).
English: This risk was particularly of concern with low molecular-weight iron-dextran (LMWID) containing products, particularly in pregnant women for whom uterine hypertonia was observed.
Danish: Denne risiko gav især anledning til betænkelighed i forbindelse med produkter indeholdende lavmolekylært jerndextran (LMWID), navnlig hos gravide kvinder, hos hvem der blev iagttaget uterus-hypertoni.
English: The most frequent AEs experienced by patients in all treatment groups were hypotension (48.7%), nausea (31.9%), vomiting (22.1%) and cramps.
Danish: De hyppigste bivirkninger, som optrådte i alle behandlingsgrupper, var hypotension (48,7 %), kvalme (31,9 %), opkastning (22,1 %) og kramper.
English: All serious cases reported with a primary event other than within the immune system disorders has been reviewed according to the common terminology criteria for adverse events (CTCAE) grade III-V in order not to oversee any severe potential allergic reactions (n=219 additional cases).
Danish: Alle alvorlige tilfælde, der blev beskrevet som en primær hændelse af ikke-immunsystemrelateret art, er gennemgået efter fælleskriterierne for benævnelse af bivirkninger (CTCAE) grad III-V for at undgå at overse potentielle allergiske reaktioner (n=219 yderligere tilfælde).
English: Furthermore, only three patients with serious adverse events related to intravenous sodium ferric gluconate have been described.
Danish: Desuden er der kun beskrevet 3 patienter med alvorlige bivirkninger i forbindelse med intravenøst natriumferrigluconat.
English: So the CHMP conclusions are applicable to all the iron complexes assessed in this referral.
Danish: CHMP's konklusioner finder derfor anvendelse på alle de jernkomplekser, der er omfattet af indbringelsen.
English: Therefore, no conclusions on safety can be drawn from these studies alone.
Danish: Disse undersøgelser giver derfor ikke i sig selv grundlag for konklusioner om sikkerheden.
English: The CHMP also agreed on the need of an updated risk management plan to be submitted for the products which have a risk management plan already; for the medicinal products which do not have an EU risk minimisation plan the CHMP is requesting the MAHs to submit one.
Danish: CHMP fastslog desuden, at der skal indsendes en opdateret risikostyringsplan for produkter, for hvilke der i forvejen findes risikostyringsplan; for produkter uden EU-risikominimeringsplan anmoder CHMP indehaverne af markedsføringstilladelsen om at indsende en sådan.