natgillin/translations-raw huggingface dataset:
De mest almindelige bivirkninger (set hos mellem 1 og 10 patienter ud af 100) er hypertension (for højt blodtryk), hovedpine, tromboemboliske hændelser (dannelse af blodpropper i blodkarrene).
The most common side effects (seen in between 1 and 10 patients in 100) are hypertension (high blood pressure), headache and thromboembolic events (formation of blood clots in the blood vessels).
Behandlingens virkning i de fleste af undersøgelserne blev bedømt på, om NeoRecormon øger hæmoglobinniveauet eller mindsker behovet for blodtransfusioner.
The main measures of effectiveness in most of the studies were whether NeoRecormon increased haemoglobin levels or whether it reduced the need for blood transfusions.
Dosisstørrelse, injektionshyppighed, og hvor længe det anvendes, afhænger af hvorfor NeoRecormon anvendes, og skal tilpasses patientens respons.
The dose, the frequency of injection, and how long it is used for depend on why NeoRecormon is used, and are adjusted according to the patient's response to treatment.
Det aktive stof i NeoRecormon, epoetin beta, er en kopi af et humant hormon kaldet erythropoietin.
The active substance in NeoRecormon, epoetin beta, is a copy of a human hormone called erythropoietin.
Behandlingen med NeoRecormon bør indledes og overvåges af en læge med erfaring i behandling af patienter med de former for anæmi, som NeoRecormon anvendes til at behandle og forebygge.
Treatment with NeoRecormon should be initiated by a doctor who has experience in the care of patients with the types of anaemia that NeoRecormon is used to treat and prevent.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af NeoRecormon?
What measures are being taken to ensure the safe and effective use of NeoRecormon?
Det øgede også mængden af blod, der kan tappes fra patienter inden en operation med henblik på autolog blodtransfusion, og mindskede behovet for transfusion hos for tidligt fødte babyer og hos kræftpatienter, der får kemoterapi.
It also increased the amount of blood that could be taken from patients before surgery for autologous blood transfusion and reduced the need for transfusion in premature babies and in cancer patients receiving chemotherapy.
Virkningen af NeoRecormon til behandling eller forebyggelse af anæmi er undersøgt i mange forsøg, der har omfattet kronisk nyresvigt (1 663 patienter, heraf nogle i sammenligningsforsøg mod placebo (virkningsløs behandling), autolog blodtransfusion (419 patienter, sammenligning med placebo), anæmi hos for tidligt fødte børn (177 spædbørn, sammenligning med ingen behandling), og kræft (1 204 patienter med forskellige kræftformer, sammenligning med placebo).
The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic renal failure (1,663 patients, including some comparative studies against placebo (a dummy treatment)), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison with no treatment), and in cancer patients (1,204 patients with different types of cancer, comparison with placebo).
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for NeoRecormon, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NeoRecormon, including the appropriate precautions to be followed by healthcare professionals and patients.
CHMP besluttede, at fordelene ved NeoRecormon opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for NeoRecormon.
The CHMP decided that NeoRecormon's benefits are greater than its risks and recommended that it be given marketing authorisation.
NeoRecormon er et lægemiddel, der stimulerer væksten af røde blodlegemer.
NeoRecormon is a medicine that stimulates red-blood-cell growth.
NeoRecormon må ikke gives til patienter med højt blodtryk, som ikke er tilstrækkelig kontrolleret.
NeoRecormon must not be used in patients who have poorly controlled high blood pressure.
Hos patienter i kemoterapi eller patienter med nyreproblemer kan der opstå anæmi, fordi de mangler erytropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på det naturligt dannede erytropoietin.
In patients receiving chemotherapy or with chronic renal failure, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
NeoRecormon må heller ikke gives til patienter, som får autolog blodtransfusion, hvis de har haft et hjerteanfald eller slagtilfælde inden for den seneste måned, hvis de har angina pectoris (en svær form for brystsmerter), eller hvis de har risiko for at udvikle dyb venetrombose (DVT, dannelse af en blodprop i en dybtliggende vene, sædvanligvis i benet).
In patients who are to undergo autologous blood transfusion, NeoRecormon must not be used if they have had a heart attack or stroke within the last month, if they have angina pectoris (a severe type of chest pain), or if they are at risk of deep venous thrombosis (DVT, formation of blood clots in the deep veins of the body, usually in the leg).
NeoRecormon er væsentligt mere effektivt end placebo (virkningsløs behandling) til at øge hæmoglobinniveauet hos patienter med forskellige former for anæmi, herunder patienter med kronisk nyresvigt.
NeoRecormon was more effective than placebo at increasing haemoglobin levels in patients with various types of anaemia, including those with chronic renal failure.
• til behandling af anæmi, som giver symptomer hos voksne, som modtager kemoterapi til behandling af ikke-myeloid cancer (cancer, der ikke har sin oprindelse i knoglemarven)
• to treat anaemia that is causing symptoms in adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer that does not affect the bone marrow);
Bivirkningerne ved NeoRecormon afhænger af årsagerne til patientens anæmi.
The types of side effects seen with NeoRecormon depend on the cause of the patient's anaemia.
• til behandling af anæmi (mangel på røde blodlegemer), som giver symptomer hos voksne og børn med "kronisk nyresvigt" (langvarig, fremadskridende nedsættelse af nyrefunktionen)
• to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly);
Den fuldstændige liste over indberettede bivirkninger ved NeoRecormon fremgår af indlægssedlen.
For the full list of all side effects reported with NeoRecormon, see the package leaflet.
Hvilken risiko er der forbundet med NeoRecormon?
What is the risk associated with NeoRecormon?
Erythropoietin dannes i nyrerene og stimulerer dannelsen af røde blodlegemer i rygmarven.
Erythropoietin is produced by the kidneys and stimulates the production of red blood cells from the bone marrow.
Hvorfor blev NeoRecormon godkendt?
Why has NeoRecormon been approved?
Epoetin beta i NeoRecormon har nøjagtigt samme stimulerende virkning i kroppen på dannelsen af røde blodlegemer som det naturlige hormon.
The epoetin beta in NeoRecormon works in the body in the same way as the natural hormone to stimulate red blood cell production.
Det fås som et pulver, der opløses i den medfølgende væske og derefter gives som injektion.
It is available as a powder and solvent in a multidose vial, to be made up into a solution for injection.
Det fås også som en fyldt injektionssprøjte.
It is also available as a pre-filled syringe.
• til at forøge mængden af blod, som kan tages fra voksne patienter med moderat anæmi, der skal opereres, og som skal donere sit eget blod inden det kirurgiske indgreb (autolog blodtransfusion).
• to increase the amount of blood that can be taken from adult patients with moderate anaemia who are going to have an operation and need to have a supply of their own blood before surgery (autologous blood transfusion).This is only done when blood storage procedures are not available or are insufficient because the surgery requires a large volume of blood.
Hvad er NeoRecormon?
What is NeoRecormon?
Hvordan blev NeoRecormon undersøgt?
How has NeoRecormon been studied?
Hvad anvendes NeoRecormon til?
What is NeoRecormon used for?
Hvilken fordel viser undersøgelserne, at der er ved NeoRecormon?
What benefit has NeoRecormon shown during the studies?
De nærmere oplysninger fremgår af indlægssedlen.
For more details, see the package leaflet.
Hvordan anvendes NeoRecormon?
How is NeoRecormon used?
Hos for tidligt fødte babyer og patienter, der får kemoterapi, skal NeoRecormon indsprøjtes under huden.
For patients with chronic renal failure, NeoRecormon can be injected into a vein or under the skin, but it must be injected under the skin in premature babies and patients receiving chemotherapy, and into a vein in patients who are going to have their blood extracted for their surgery.
Hvordan virker NeoRecormon?
How does NeoRecormon work?
Fordele/risici
Benefit/risk
I EU eksisterer der alternative muligheder for de pågældende indikationer.
Alternative options are available in the EU for the concerned indications.
I Norge blev de fleste af disse foranstaltninger allerede truffet i 1995, uden at det havde nogen effekt på den måde, hvorpå lægemidlet blev ordineret og anvendt.
In Norway most of these activities were implemented already in 1995 without any effect on the way the product was prescribed and used.
De omfatter tabletter og suppositorier, som kan fås på recept i 12 EU-medlemsstater.
They include tablets and supositories available under prescription in 12 EU Member States.
BEGRUNDELSE FOR SUSPENDERINGEN AF MARKEDSFØRINGSTILLADELSERNE
GROUNDS FOR THE SUSPENSION OF THE MARKETING AUTHORISATIONS
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE CARISOPRODOL (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING CARISOPRODOL (see Annex I)
• Data, der dokumenterer en overbevisende effektivitet og sikkerhed, som bygger på hensigtsmæssigt tilrettelagte kliniske undersøgelser (herunder en aktiv komparator), og data, der begrunder den foreslåede dosis.
• Data demonstrating convincing efficacy and safety derived from appropriately designed clinical trials (including an active comparator) and data justifying the proposed dose.
De tre observationsundersøgelser, der blev offentliggjort i Norge i 2007, gav dokumentation for de tegn på misbrug og svækkelse, som blev identificeret i det spontane rapporteringssystem i Norge.
The three observational studies published in Norway in 2007 gave evidence for the signals of abuse and impairment identified by the spontaneous reporting system in Norway.
• Data, der dokumenterer, at lægemidlerne kan bruges på en sikker måde, idet der tages højde for informationer om forgiftninger fra giftinformationscentralerne i Europa.
• Data demonstrating that the products can be used safely taking into account information on intoxications from poison centres in Europe.
Desuden er der data fra giftinformationscentralerne, som bekræfter disse bekymringer.
In addition there is data from poison information centres confirming these concerns.
• Detaljerede risikominimeringsforanstaltninger og metoder til at sikre, at det er muligt at foretage en passende vurdering af sådanne foranstaltningers effekt, når de er blevet gennemført.
• Detailed risk minimisation measures and ways to ensure that the impact of such measures could be adequately evaluated once in place.
Indehaveren af markedsføringstilladelsen traf beslutningen om frivillig tilbagetrækning som følge af den norske kompetente myndigheds vurdering.
The Marketing Authorisation Holder decided on the voluntary withdrawal on the basis of the assessment performed by the Norwegian Competent Authority.
Lægemidler, der indeholder carisoprodol, har kunnet fås i Europa siden 1959 og er tilladt i en række EU-medlemsstater (se bilag I for listen over lægemidler indeholdende carisoprodol, der er tilladt i EU).
Medicinal products containing carisoprodol have been available in Europe since 1959 and are authorised in a number of EU Member States (see Annex I for the list of carisoprodol containing medicinal products authorised in the EU).
Hvad angår andre indikationer, der er tilladt i nogle lande, må det konkluderes, at effektiviteten ikke er dokumenteret, men er baseret på udokumenterede rapporter om den kliniske effekt.
For other indications authorised in some countries it must be concluded that the efficacy is not documented, but it is based on anecdotal reports on clinical effect.
Ud fra dette synspunkt er man af den opfattelse, at medmindre risikominimeringsforanstaltningerne kan overvåges, og deres virkning kan vurderes præcist, er de ikke et punkt, der skal tages hensyn til ved vurderingen af carisoprodols anvendelse.
In this perspective it is considered that unless the risk minimisation measures can be monitored and their impact can be evaluated accurately they could not be a valuable point in the evaluation of the use of carisoprodol.
Effektivitetsbeviset for forskellig dosering af carisoprodol og for kombinationsprodukter mangler fuldstændigt.
The proof of efficacy for different dosing of carisoprodol and for combination products is missing completely.
CHMP drøftede spørgsmålet på sit plenarmøde i september 2007, og proceduren ifølge artikel 107, stk. 2, i direktiv 2001/83/EF, med senere ændringer, blev indledt på CHMP's møde i september 2007.
The CHMP discussed the matter at its September 2007 plenary meeting and the procedure in accordance with Article 107(2) of Directive 2001/83/EC, as amended was started at the September 2007 CHMP meeting.
Indehaverne af markedsføringstilladelsen har foreslået adskillige risikominimeringsforanstaltninger (f.eks. en begrænsning af indikationen, en anbefaling af, at der udelukkende anvendes korttidsbehandling, udlevering af kun en lille pakke og ændring af receptkategorien til en mere restriktiv kategori).
Several risk minimisation activities (such as restriction of the indication, recommendation of only short term treatment, supply of only small package and change of the prescription category to a more restrictive) have been proposed by the MAHs.
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR SUSPENDERING AF MARKEDSFØRINGSTILLADELSERNE FREMLAGT AF EMEA
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS PRESENTED BY THE EMEA
Desuden foreligger der oplysninger om spontane rapporter samt rapporter fra giftinformationscentraler i Europa og USA, som viser, at der er problemer med forgiftninger.
In addition there is information on spontaneous reports as well as reports from poison centers in Europe and in the US that there are problems related to intoxications.
Derfor er det i praksis svært at opnå et sikkert mønster for anvendelsen af lægemidler indeholdende carisoprodol hos mange patienter.
Therefore, in practice a safe pattern of use of carisoprodol containing products is difficult to achieve in many patients.
Desuden noterede CHMP sig, at der eksisterer anden effektiv medicin med en bedre sikkerhedsprofil til behandling af akutte nedre rygsmerter.
Furthermore the CHMP took note that there are other effective medications with a more favourable safety profile for the treatment of acute low back pain.
I en af disse undersøgelser konkluderede man, at patienter, der får carisoprodol, tilsyneladende havde en øget risiko for at blive indblandet i trafikuheld, hvor der sker personskade.
In one of these studies it was concluded that patients receiving carisoprodol seemed to have an increased risk of being involved in traffic accidents involving person injury.
Alle lægemidler indeholdende carisoprodol i EU har opnået tilladelse efter de nationale procedurer.
All carisoprodol containing medicinal products in the EU are authorised according to national procedures.
I de nylige observationsundersøgelser var ordineringsmønsteret stadig skævt.
In the recent observational studies the prescribing patterns continued to be distorted.
Der er blevet offentliggjort en række artikler, som beskriver dets misbrugspotentiale, giftighed og afhængighed.
A number of articles describing its abuse potential, toxicity and dependence have been published.
Manglen på nye sikkerhedsundersøgelser, hvor man sammenligner carisoprodol med andre smertestillende midler til samme indikation og med en bedre undersøgt sikkerhedsprofil, understreger nødvendigheden af yderligere systematiske undersøgelser.
The lack of recent safety studies comparing carisoprodol to other analgesic products with a better studied safety profile available for the same indication emphasizes the need for further systematic investigation.
Den farmakokinetiske del af den pågældende undersøgelse viste, at blodkoncentrationskurven for carisoprodol stiger og falder hurtigt.
The pharmacokinetic part of the above mentioned study showed that the blood concentration curve of carisoprodol increases and falls rapidly.
Derfor anbefalede CHMP en suspendering af markedsføringstilladelserne for alle lægemidler indeholdende carisoprodol, der er anført i bilag I. For at få suspenderingen ophævet skal indehaverne af markedsføringstilladelserne fremlægge:
Thus the CHMP recommended the suspension of the Marketing Authorisations for all carisoprodol containing medicinal products listed in Annex I. For the suspension to be lifted the Marketing Authorisation Holders would need to provide:
Den 20. april 2007 udsendte Norges kompetente myndighed (NoMA) en hurtig varslingsmeddelelse, som i henhold til artikel 107 i direktiv 2001/83/EF, med senere ændringer, informerede medlemsstaterne, EMEA og Kommissionen om den beslutning, som indehaveren af markedsføringstilladelsen, Actavis, havde truffet om frivilligt den 1. maj 2008 at trække markedsføringstilladelserne tilbage for lægemidler indeholdende carisoprodol i medlemsstaten.
On 20 April 2007, the Norwegian Competent Authority (NoMA) issued a Rapid Alert informing the Member States, the EMEA and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of the decision by the Marketing Authorisation Holder Actavis to voluntarily withdraw as of 1 May 2008 the Marketing Authorisations for carisoprodol containing medicinal products in its Member State.
Disse symptomer kan tilskrives carisoprodols lave terapeutiske indeks.
These symptoms are attributable to the low therapeutic index of carisoprodol.
Udvalget fulgte proceduren i artikel 107 i direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende carisoprodol.
The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing carisoprodol;
Det betyder, at bivirkninger, som skyldes høje koncentrationer af carisoprodol, er nemmere at identificere.
This means that adverse drug reactions related to high carisoprodol concentrations are easier to identify.
På baggrund af alle disse elementer konkluderede CHMP, at benefit/risk-forholdet for carisoprodol ikke er gunstigt, og CHMP anbefalede suspendering af markedsføringstilladelserne for de lægemidler, der er anført i bilag I.
Taking all these elements into account, the CHMP concluded that the benefit/risk ratio for carisoprodol is not considered favourable and recommended the suspension of the Marketing Authorisations for the medicinal products referred to in Annex I.
I resultaterne fra undersøgelsen, som blev indsendt under denne procedurebehandling, observerede man psykomotorisk svækkelse og andre former for svækkelse ca. 1,5 time efter indtagelsen, hvilket indicerer, at disse virkninger er forbundet med carisoprodol i sig selv og ikke med dets metabolitter.
In the results from the study which was submitted during this procedure sedation, psychomotor impairment and other impairments were observed about 1.5 hour after ingestion, indicating these are effects associated with carisoprodol itself and not its metabolites.
Eftersom de farmakologiske undersøgelser af carisoprodol er begrænset til enkeltdosisundersøgelser, har der været en vis usikkerhed med hensyn til mekanismen for de observerede virkninger af carisoprodol, og hvorvidt de er forbundet med carisoprodol i sig selv eller med dets metabolitter.
As pharmacological studies with carisoprodol have been limited to single dose studies, there have been some uncertainties to the mechanism for the observed effects of carisoprodol and whether they are associated with carisoprodol itself or with its metabolites.
I lyset af ovenstående betragtninger konkluderede udvalget, at benefit/risk-forholdet for carisoprodol ikke længere er positivt.
The Committee in light of the above findings concluded that the benefit/risk balance of carisoprodol containing medicinal products is no longer positive.
Serumkoncentrationerne for carisoprodol samt de farmakodynamiske resultater med hensyn til søvntrang, som man nåede frem til i denne undersøgelse, bekræftede klart resultaterne af de norske observationsundersøgelser, nemlig at der bør advares kraftigt imod anvendelse af motorkøretøjer som følge af søvntrang ved brug af lægemidler med carisoprodol.
The serum concentrations for carisoprodol together with the pharmacodynamic results on somnolence found in this study clearly confirmed the Norwegian observational study results that there should be strong warnings against the use of motor vehicle due to somnolence when using carisoprodol medication.
Carisoprodol er et centralt virkende lægemiddel, der hovedsagelig er indiceret til korttidsbehandling af akutte nedre rygsmerter.
Carisoprodol is a centrally acting drug mainly indicated for short-term treatment of acute lower back pain.
Undersøgelsen underbyggede tidligere publikationer om carisoprodols sløvende virkning.
The study gave support to earlier work published on the impairing effects of carisoprodol.
Indehaverne af markedsføringstilladelsen for lægemidler indeholdende carisoprodol har ikke fremlagt nogen pålidelige kliniske data, der kunne bevise carisoprodols effektivitet.
The MAHs of carisoprodol containing products have not provided any sound clinical data, which would demonstrate the efficacy of carisoprodol.
Der er flere videnskabelige publikationer, som analyserer bivirkninger i form af forgiftninger og psykomotorisk svækkelse.
There are several scientific publications analysing the adverse effects of intoxication and psychomotor impairment.
Akutte nedre rygsmerter er den eneste indikation, der er dokumenteret i tre randomiserede, kontrollerede kliniske undersøgelser, hvor der blev anvendt carisoprodol 350 mg.
Acute lower back pain is the only indication that has been documented by three randomised, controlled clinical studies using carisoprodol 350mg performed in the 60's and 70's and which do not fulfill current stardard for the Phase III clinical trials.
NoMA konkluderede i sin vurdering, at carisoprodol gav en øget risiko for misbrug eller afhængighed, forgiftning og hændelser i forbindelse med psykomotorisk svækkelse.
In its assessment NoMA concluded that carisoprodol was associated with an increased risk of abuse or addiction, intoxication and events related to psychomotor impairment.
De nedre rygsmerters karakter har dog medført en tendens til en mere kronisk brug af lægemidlet, hvilket øger risikoen for afhængighed.
The Committee considered that carisoprodol is indicated primarily for acute low back pain, however, because of the nature of low back pain this has resulted in a tendency for more chronic use of the drug, increasing the risk of dependence.
Udvalget konkluderede, at der er stadig større dokumentation for, at carisoprodol giver risiko for misbrug, psykomotorisk svækkelse og forgiftning.
The Committee concluded that there is increasing evidence for carisoprodol-associated risk of abuse, psychomotor impairment and intoxications.
Carisoprodol giver risiko for misbrug, psykomotorisk svækkelse og forgiftning.
Carisoprodol is associated with a risk of abuse, psychomotor impairment and intoxication.
Der er dokumentation for, at carisoprodol giver risiko for misbrug, psykomotorisk svækkelse og forgiftning.
There is available evidence that carisoprodol is associated with a risk of abuse, psychomotor impairment and intoxication.