natgillin/translations-raw huggingface dataset:
På grundlag af samme Eudravigilance-datasæt bemærkede CHMP desuden 11 tilfælde af abstinenssymptomer, heraf ét med dødelig udgang.
Based on the same Eudravigilance dataset, the CHMP also noted 11 cases of withdrawal symptoms, of which one was fatal.
Med behørigt hensyn til den alvorlige risiko for abstinenssymptomer anbefalede CHMP, at tilbagetrækningen af meprobamat fra markedet gennemføres over en periode på 15 måneder for at sikre risikofrit ophør af behandling eller overgang til anden behandling for patienter i behandling med meprobamat.
Giving due consideration to the serious risk of withdrawal symptoms, the CHMP recommended that the withdrawal of meprobamate from the market should be implemented over a 15 month period, in order to ensure the safe termination of treatment or switching of patients already being treated with meprobamate.
CHMP konstaterede, at de foreliggende data om virkningen af meprobamat for visse indikationers vedkommende er begrænsede, og for andres vedkommende ikke-eksisterende.
The CHMP noted that the available data on the efficacy of meprobamate is limited in some indications and non-existent in others.
• udvalget rejste betænkeligheder ved den betydelige andel af ældre patienter og anvendelsen hos denne population, navnlig på baggrund af den øgede risiko for bivirkninger gennem interaktioner med anden samtidig medicinering,
• The Committee raised concerns regarding the considerable proportion of elderly patients and regarding use in this population, especially considering the increased risk of adverse events due to interactions with concomitant medication.
To nylige lægemiddelovervågningsanalyser af data fra spontane indberetninger, som blev udført af CRPV (Centre régional de pharmacovigilance) i Lille og afsluttet i 2011, viste ikke nævneværdig virkning af risikominimeringsforanstaltningerne, men påpegede, at der manglende kliniske data vedrørende produkternes fordele.
Two recent pharmacovigilance analyses of data from spontaneous reports, conducted by the Lille CRPV (Centre régional de pharmacovigilance) and finalised in 2011, did not identify any significant impact of the implemented risk minimisation measures and noted the lack of clinical data on the benefit of these products.
Meprobamat anses for at have et relativt smalt terapeutisk indeks med en stejl dosis-responskurve, hvilket medfører øget risiko for accidentel overdosering med alvorlige og potentielt dødelige bivirkninger, herunder koma, dyb hypotension, hypotermi, respirationsstop og kardiogent shock.
Meprobamate is considered to have a relatively narrow therapeutic index, with a steep dose-response curve, resulting in an increased risk of unintentional overdoses with serious and potentially fatal adverse events, including coma, profound hypotension, hypothermia, respiratory arrest and cardiogenic shock.
• CHMP konkluderede derfor, at benefit/risk-forholdet for lægemidler indeholdende meprobamat ikke er positivt under normale anvendelsesbetingelser,
• The CHMP therefore concluded that the risk-benefit balance of meprobamate-containing medicinal products for oral use is not positive under normal conditions of use.
• CHMP fandt, at de foreliggende data kun viser meget begrænset klinisk virkning af meprobamat til de godkendte indikationer,
• The CHMP considered that the available data showed only very limited clinical efficacy of meprobamate in its approved indications.
For at vurdere sikkerhedsprofilen af meprobamat, især neurologiske og psykiatriske bivirkninger, herunder lægemiddelafhængighed og alvorlige abstinenssymptomer under normale anvendelsesbetingelser, navnlig hos ældre, gennemgik CHMP data fra de to lægemiddelovervågningsanalyser af sikkerhedsdata for det aktive stof, der var udført af CRPV i Lille og var grundlag for Afssaps's beslutning om at suspendere markedsføringstilladelserne for de berørte produkter.
Therefore, in order to assess the safety profile of meprobamate, mainly neurological and psychiatric adverse events, including pharmacodependence and serious withdrawal symptoms under normal conditions of use, particularly in the elderly, the CHMP reviewed the data from the two pharmacovigilance analyses of safety data on meprobamate conducted by the Lille CRPV, which were the basis of the Afssaps decision to suspend the marketing authorisations for the products concerned.
CHMP bemærkede desuden, at de foreliggende retningslinjer for behandling af angsttilstande, alkoholabstinenser og migræne ikke indeholder en anbefaling af at anvende meprobamat.
The CHMP also noted that the available medical practice guidelines for anxiety disorder, alcohol withdrawal and migraine do not recommend meprobamate.
CHMP anerkendte i øvrigt den potentielle konfunderende effekt af comedicinering i næsten alle tilfældene, især med psykoaktive midler.
The CHMP also acknowledged the potential confounding effect of co-medication as patients were co-medicated in almost all cases, particularly with psychotropic drugs.
CHMP gennemgik de foreliggende data, der var indsendt af indehaverne af markedsføringstilladelserne, men fandt disse begrænsede data utilstrækkelige til at drage konklusioner om sikkerheden af meprobamat og forudsigeligheden af eventuelle tilknyttede risici.
The CHMP reviewed the available data submitted by the MAHs but considered that this limited data was insufficient to conclude on the safety of meprobamate and the predictability of any associated risks.
For enkeltstofprodukter indeholdende meprobamat fandtes 119 lægeligt bekræftede tilfælde i den første analyse udført af CPRV i Lille efter gennemførelsen af risikominimeringsforanstaltningerne, hvilket svarede til perioden inden gennemførelsen, skønt salgstallene lod formode, at patienteksponeringen var faldet.
Regarding meprobamate-only products, the first Lille CPRV analysis identified 119 medically confirmed cases following the implementation of the risk minimisation measures, which was similar to the data for the period prior to the implementation, despite an assumed reduction in patient exposure, based on sales data.
Efter at der var foretaget en række nationale franske gennemgange af sikkerhed og virkning samt lægemiddelovervågningsanalyser af meprobamat, indførte de franske kompetente myndigheder (Afssaps) risikominimeringsforanstaltninger med henblik på de konstaterede risici ved meprobamat og iværksatte nationale lægemiddelovervågningsanalyser til vurdering af foranstaltningernes virkning.
Following a number of French national safety and efficacy reviews and pharmacovigilance analyses of meprobamate, the French National Competent Authority (Afssaps) implemented risk minimisation measures to reduce the identified risks of meprobamate and initiated national pharmacovigilance analyses to assess the impact of these measures.
Meprobamat, der er et derivat af carbamat, er et CNS-deprimerende middel med anxiolytisk, sedativ og muskelafslappende virkning.
Meprobamate is a carbamate derivative, acting as a central nervous system depressant with anxietyrelieving, sedative and muscle relaxant activity.
Derudover var der i Afssaps 101 særlig betænkelighed ved bivirkninger hos ældre patienter.
In addition, Afssaps was particularly concerned by adverse events in elderly patients.
I undersøgelsesperioden forekom de vigtigste rapporterede bivirkninger hovedsagelig i systemorganklasserne (SOC) nervesystemet (34 %) og procedurebetingede skader/forgiftninger og almene symptomer (8 %).
During the study period, the main adverse events occurred generally in the SOCs nervous system disorders (34%), procedure-related lesions/intoxications and complications (8%) and general disorders (8%).
CHMP noterede sig desuden lægemiddelovervågningsanalyserne af virkningen af de risikominimeringsforanstaltninger for meprobamat og meprobamat/aceprometazin, der var gennemført i Frankrig uden at medføre nævneværdig eller tilstrækkelig reduktion af incidensen af bivirkninger med sammenhæng med meprobamat, heller ikke under normale anvendelsesbetingelser.
The CHMP also noted the pharmacovigilance analyses of the impact of the risk minimisation measures for meprobamate and meprobamate/aceprometazine implemented in France, which did not result in a significant nor sufficient reduction of the incidence of adverse reactions associated with meprobamate, including in cases of normal conditions of use.
Én indehaver af markedsføringstilladelse anså benefit/risk-forholdet for meprobamat for at være negativt ved indikationen alkoholabstinenser og ville slette denne indikation, hvor den er godkendt.
One MAH considered the benefit-risk of meprobamate to be negative in the alcohol withdrawal indication and proposed to remove the indication where authorised.
Meprobamat kan medføre fysisk og psykisk afhængighed og et potentielt livstruende abstinenssyndrom med delirium ved pludselig seponering, navnlig efter langvarig brug, og med farmakologiske virkninger svarende til virkningerne af alkohol og barbiturater.
Meprobamate can cause physical and psychological dependence and a potentially life-threatening abstinence syndrome with delirium on abrupt withdrawal, in particular after prolonged use, with pharmacological effects similar to those of alcohol and barbiturates, including within the normal dosage and treatment duration, due to the nature of the product.
CHMP konstaterede, at størstedelen af indehaverne af markedsføringstilladelserne svarede, at de anså benefit/risk-forholdet for deres produkter for positivt, og at de fundne sikkerhedsmæssige betænkeligheder ville kunne imødekommes tilfredsstillende ved sædvanlig lægemiddelovervågning.
The CHMP noted that the majority of MAHs responded that they considered the benefit-risk of their products to be positive and that routine pharmacovigilance activities were sufficient to address the identified safety concerns.
CHMP konkluderede, at der ikke kan udpeges risikominimeringsforanstaltninger, der vil mindske de konstaterede risici ved brugen af meprobamat til et klinisk acceptabelt niveau, navnlig vedrørende ældre patienter og risikoen for lægemiddelafhængighed.
The CHMP concluded that no risk minimisations measures could be identified that would adequately reduce the identified risks associated with the use of meprobamate to a clinically acceptable level, especially with regard to elderly patients and the risk of pharmacodependence.
Meprobamat kan fremkalde generaliserede tonisk-kloniske attakker hos prædisponerede personer, hvilket kan være uheldigt ved alkoholabstinenser karakteriseret af øget krampetendens.
Meprobamate may induce generalized tonic-clonic attacks in the predisposed which may be a drawback during alcohol withdrawal, a condition characterized by an increased susceptibility to convulsions.
Denne analyse vurderede virkningen på produkternes risikoprofil af gennemførelsen af risikominimeringsforanstaltningerne i 2009 (indskrænkning af indikationerne, begrænsning af pakningsstørrelsen og udsendelse af en DHPC).
This analysis assessed the impact of the implementation of the 2009 risk minimisation measures (restriction of the indications, reduction of pack size and circulation of a DHPC) on their risk profile.
CHMP var af den opfattelse, at patienter, der behandles for alkoholabstinenser, risikerer alvorlige bivirkninger på baggrund af, at leverfunktionen må forventes at være nedsat hos de fleste patienter med kroniske alkoholproblemer.
The CHMP was of the opinion that patients who are being treated for alcohol withdrawal are at risk of serious adverse reactions, given that liver function is likely to be affected in most patients with chronic alcohol problems.
• udvalget tog i betragtning, at der er indberettet en række neurologiske og psykiatriske bivirkninger af meprobamat, som kan være alvorlige og potentielt dødelige, også under normale anvendelsesbetingelser,
• The Committee considered that a number of neurological and psychiatric adverse events, which can be serious and potentially fatal, have been reported with the use of meprobamate, including under normal conditions of use.
Som konklusion var det CHMP's opfattelse, at der ikke kunne udpeges risikominimeringsforanstaltninger, der ville mindske de konstaterede risici ved brugen af meprobamat til et klinisk acceptabelt niveau under normale anvendelsesbetingelser.
In conclusion, the CHMP was of the opinion that no risk minimisations measures could be identified that would adequately reduce the identified risks associated with the use of meprobamate to a clinically acceptable level within normal conditions of use.
Hvad angår risikominimeringsforanstaltninger gennemgik CHMP de lægemiddelovervågningsanalyser af virkningen af de risikominimeringsforanstaltninger for meprobamat og meprobamat/aceprometazin, der var indført i Frankrig, og de begrænsede yderligere risikominimeringsforanstaltninger, der var foreslået af indehaverne af markedsføringstilladelserne.
With regard to risk minimisation measures, the CHMP reviewed the pharmacovigilance analyses of the impact of the risk minimisation measures for meprobamate and meprobamate/aceprometazine implemented in France and the limited additional risk minimisation measures proposed by the MAHs.
• på grundlag af vurderingen af virkningen af de i Frankrig gennemførte foranstaltninger til risikominimering og de begrænsede yderligere risikominimeringsforanstaltninger, der var foreslået af indehaverne af markedsføringstilladelserne, fandt CHMP, at der ikke kan udpeges risikominimeringsforanstaltninger, som vil reducere de konstaterede risici ved anvendelsen af meprobamat til et klinisk acceptabelt niveau,
• The CHMP considered, based on the assessment of the impact of the risk minimisation measures implemented in France and of the limited additional risk minimisation measures proposed by the MAHs, that no risk minimisations measures could be identified that would adequately reduce the identified risks associated with the use of meprobamate to a clinically acceptable level.
CHMP fandt, at der var risiko for lægemiddelafhængighed på grundlag af data vedrørende anvendelsen fra en database over sygeforsikringskrav, som viste langvarig brug af meprobamat.
The CHMP considered that the data identified a risk of pharmacodependence, based on utilization data issued from a claims database showing prolonged use of meprobamate.
• udvalget konstaterede, at meprobamat har et relativt smalt terapeutisk indeks, og anså derfor accidentel overdosering, der ofte er alvorlig og kan være dødelig, for at udgøre en alvorlig risiko ved anvendelsen af meprobamat,
• The Committee noted that meprobamate has a relatively narrow therapeutic index and therefore considered that accidental overdoses, which are often serious and can be fatal, are a serious risk with meprobamate.
CHMP gennemgik forslagene fra indehaverne af markedsføringstilladelserne, man fandt dem utilstrækkelige til at nedsætte den udpegede risiko ved meprobamat.
The CHMP reviewed the MAH proposals but considered them insufficient to reduce the identified risk of meprobamate.
Vedrørende sikkerheden tog CHMP i betragtning, at der er indberettet en række alvorlige bivirkninger af meprobamat, dels neurologiske (koma, bevidsthedstab), dels psykiatriske (lægemiddelafhængighed og abstinenssymptomer), som kan være alvorlige og potentielt dødelige, også under normale anvendelsesbetingelser.
With regards to safety, the CHMP considered that a number of serious neurological (coma, loss of consciousness) and psychiatric (pharmacodependence and withdrawal symptoms) adverse events, which can be serious and potentially fatal, have been reported with the use of meprobamate, including under normal conditions of use.
I undersøgelsesperioden var de vigtigste rapporterede bivirkninger hovedsagelig i systemorganklasserne (SOC) nervesystemet (29 %) og procedurebetingede skader/forgiftninger og komplikationer (12 %).
System Organ Classes (SOCs) nervous system disorders (29%) and procedure-related lesions/intoxications and complications (12%).
Uanset at virkningen stort set er uændret siden udstedelsen af den oprindelige markedsføringstilladelse, fandt CHMP, at de foreliggende data kun dokumenterer meget begrænset klinisk virkning af meprobamat til de godkendte indikationer.
In addition, while the efficacy remains largely unchanged since the granting of the initial marketing authorisation, the CHMP was of the opinion that the available data showed only very limited clinical efficacy of meprobamate in its approved indications.
• CHMP tog i betragtning, at meprobamat har potentiale for lægemiddelafhængighed under normale anvendelsesbetingelser og derfor er forbundet med risiko for alvorlige abstinenssymptomer,
• The CHMP considered that meprobamate has a potential for pharmacodependence under normal conditions of use and that as a consequence, meprobamate is also associated with a risk of serious withdrawal symptoms.
Denne analyse vurderede virkningen på produktets risikoprofil af gennemførelsen af risikominimeringsforanstaltningerne (indskrænkning af indikationer og dosis samt begrænsning af pakningsstørrelsen).
This analysis assessed the impact of the implementation of risk minimisation measures (restriction of the indication and the posology as well as a reduction of the pack size) on its risk profile.
CHMP bemærkede, at meprobamat har et forholdsvis smalt terapeutisk indeks med en stejl dosis-responskurve, hvilket ses af de foreliggende data, der viser en række tilfælde er accidentel overdosering, som ofte er alvorlige og for nogles vedkommende dødelige.
The CHMP noted that meprobamate has a relatively narrow therapeutic index, with a steep dose-response curve, as supported by the available data which identified a number of accidental overdoses which were often serious, including fatalities.
• CHMP var af den opfattelse, at patienter, der behandles for at alkoholabstinenser, risikerer potentielle alvorlige bivirkninger som følge af nedsat leverfunktion,
• The CHMP is of the opinion that patients treated for alcohol withdrawal are at risk of potential serious adverse reactions due to impaired liver function.
Endelig var det CHMP's opfattelse, at patienter i behandling for alkoholabstinenser risikerer alvorlige bivirkninger som følge af nedsat leverfunktion.
Finally, the CHMP was of the opinion that patients treated for alcohol withdrawal are at risk of potential serious adverse reactions due to impaired liver function.
CHMP konstaterede, at meprobamat har et forholdsvis smalt terapeutisk indeks med en stejl dosis-responskurve, hvorfor udvalget konkluderede, at accidentel overdosering er en alvorlig risiko ved meprobamat.
Noting that meprobamate has a relatively narrow therapeutic index, with a steep dose-response curve, the CHMP therefore concluded that accidental overdoses are a serious risk with meprobamate.
Virkningen er i det store hele uændret siden udstedelsen af den oprindelige markedsføringstilladelse, men CHMP konkluderede, at den foreliggende dokumentation kun viser en meget begrænset klinisk virkning af meprobamat til de godkendte indikationer.
In conclusion, while the efficacy remains largely unchanged since the granting of the initial marketing authorisation, the CHMP was of the opinion that the available data showed only very limited clinical efficacy of meprobamate in its approved indications.
Som konklusion var det CHMP's opfattelse, at benefit/risk-forholdet for lægemidler indeholdende meprobamat til oral indgift ikke er positivt under normale anvendelsesbetingelser i betragtning af de alvorlige neurologiske og psykiatriske bivirkninger, der er forbundet med brug af meprobamat under normale anvendelsesbetingelser, risikoen for accidentel overdosering og for lægemiddelafhængighed og dermed forbundne abstinenssymptomer, den meget begrænsede kliniske dokumentation for meprobamat og den manglende effektivitet af de gennemførte og foreslåede risikominimeringsforanstaltninger.
In conclusion, taking into account the serious neurological and psychiatric adverse events associated with the use of meprobamate, including under normal conditions of use, the risk of accidental overdoses and of pharmacodependence associated with withdrawal symptoms, the very limited clinical evidence of meprobamate and the lack of effectiveness of the implemented and proposed risk minimisation measures, the CHMP was of the opinion that the risk-benefit balance of meprobamatecontaining medicinal products for oral use is not positive under normal conditions of use.
CHMP tog desuden i betragtning, at meprobamat har potentiale for lægemiddelafhængighed efter langvarig brug, hvilket medfører risiko for alvorlige abstinenssymptomer, som kan være dødelige.
The CHMP also considered that meprobamate has a potential for pharmacodependence after prolonged use, leading to a risk of withdrawal symptoms which are serious and can be fatal.
CHMP konkluderede på dette grundlag, at meprobamat efter langvarig brug har potentiale for lægemiddelafhængighed med risiko for abstinenssymptomer, som er alvorlige og kan have dødelig udgang.
The CHMP therefore concluded that meprobamate has a potential for pharmacodependence after prolonged use, leading to a risk of withdrawal symptoms which are serious and can be fatal.
Enzymet, der er ansvarlig for metaboliseringen af desloratadin, er endnu ikke blevet identificeret , og nogle interaktioner med andre lægemidler kan derfor ikke fuldstændigt udelukkes.
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded.
Behandling med Azomyr reducerede også signifikant påvirkningen af søvn og daglig funktionsevne, målt ved en fire-points skala, der anvendtes for at vurdere disse parametre.
Treatment with Azomyr also significantly reduced interference with sleep and daytime function, as measured by a four-point scale used to assess these variables.
Du skal udvise forsigtighed, hvis du tager Azomyr sammen med alkohol.
Use caution when taking Azomyr with alcohol.
Der er ingen kendte interaktioner mellem Azomyr og andre lægemidler.
There are no known interactions of Azomyr with other medicines.
Azomyr regulerede effektivt symptomerne i 24 timer.
Azomyr effectively controlled symptoms for 24 hours.
Sikkerheden af desloratadin syrup-formuleringen, som indeholder samme koncentration af desloratadin som Azomyr oral opløsning, blev imidlertid påvist i tre pædiatriske studier.
However, the safety of desloratadine syrup formulation, which contains the same concentration of desloratadine as Azomyr oral solution, was demonstrated in three paediatric trials.
Hvad Azomyr er Azomyr indeholder desloratadin, som er et antihistamin.
What Azomyr is Azomyr contains desloratadine which is an antihistamine.
Da Azomyr oral opløsning indeholder samme koncentration af desloratadin, var et bioækvivalensstudie ikke nødvendigt, og den orale opløsning forventes at være ækvivalent med syruppen og tabletten.
As Azomyr oral solution contains the same concentration of desloratadine, no bioequivalence study was required and it is expected to be equivalent to the syrup and tablet.
I kliniske studier i en pædiatrisk population blev desloratadin syrup anvendt til ialt 246 børn i alderen 6 måneder til 11 år.
In clinical trials in a paediatric population, the desloratadine syrup formulation was administered to a total of 246 children aged 6 months through 11 years.
Hvornår Azomyr skal bruges
When Azomyr should be used
I to placebokontrollerede seks-ugers studier hos patienter med kronisk idiopatisk urticaria var Azomyr effektivt til at lindre kløe og mindske størrelsen og antallet af kløende udslæt ved slutningen af det første doseringsinterval.
In two placebo-controlled six week trials in patients with chronic idiopathic urticaria, Azomyr was effective in relieving pruritus and decreasing the size and number of hives by the end of the first dosing interval.
Virkningen af Azomyr smeltetablet forventes derfor at være den samme som med Azomyr tabletformuleringen.
Therefore, the efficacy of Azomyr orodispersible tablet is expected to be the same as with the Azomyr tablet formulation.