natgillin/translations-raw huggingface dataset:
Resultaterne fra et hovedstudie, der omfattede 93 børn i alderen 5-17 år med aktiv SLE, viste, at Benlysta blev distribueret i kroppen på samme måde som hos voksne og kunne forventes at have tilsvarende fordele.
Results from a main study involving 93 children aged 5 to 17 years with active SLE showed that Benlysta was distributed in the body in a similar way as in adults and could be expected to have similar benefits.
Patienterne kan selv injicere Benlysta, når de har lært at gøre det, hvis lægen finder det hensigtsmæssigt.
Patients may inject Benlysta themselves once they have been properly trained, if the doctor considers this appropriate.
Lægemidlet kan forårsage infusionsrelaterede reaktioner, overfølsomhedsreaktioner og infektioner, men det tåles generelt godt.
The medicine may cause infusion and hypersensitivity reactions as well as infections, but is generally well tolerated.
Behandlingen kan afbrydes eller indstilles af lægen, hvis patienten udvikler infusionsrelaterede reaktioner (f.eks. udslæt, kløe eller vejrtrækningsproblemer) eller overfølsomhedsreaktioner (allergiske reaktioner), som kan være alvorlige og livstruende og kan udvikle sig flere timer efter, at patienten har fået Benlysta.
The doctor may interrupt or stop treatment if the patient develops reactions linked to the infusion (such as rash, itchiness and difficulty breathing) or hypersensitivity (allergic) reactions which may be severe and life-threatening and can develop several hours after Benlysta is given.
Når Benlysta gives som infusion (drop) i en vene, er den anbefalede dosis 10 mg pr. kg legemsvægt, der indgives over en time.
When Benlysta is given as an infusion into a vein, the recommended dose is 10 mg per kilogram body weight given over one hour.
Hvilke risici er der forbundet med Benlysta?
What are the risks associated with Benlysta?
Ved at blokere funktionen af BLyS reducerer belimumab B-lymfocytternes levetid og reducerer dermed den betændelsestilstand og organskade, der forekommer ved SLE.
By blocking the action of BLyS, belimumab reduces the life span of B lymphocytes, thereby reducing the inflammation and organ damage that occur in SLE.
Hvis du ønsker mere information om anvendelsen af Benlysta, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Benlysta, see the package leaflet or contact your doctor or pharmacist.
Det aktive stof i Benlysta, belimumab, er et monoklonalt antistof, dvs. et protein, der er designet til at binde til og blokere proteinet BLyS, som hjælper B-lymfocytterne med at leve længere.
The active substance in Benlysta, belimumab, is a monoclonal antibody, a protein that has been designed to attach to and block a protein called BLyS which helps B lymphocytes to live longer.
Et tredje studie omfattede 836 voksne patienter med aktiv SLE, og som fik Benlysta som tillægsbehandling injiceret under huden én gang om ugen i et år.
Another study involved 836 adult patients with active SLE, who received add-on Benlysta as an injection under the skin once a week for a year.
Benlysta fås som et pulver (120 mg og 400 mg), som opblandes til en væske, der indgives som infusion (drop) i en vene; det fås også i en fyldt pen og en fyldt sprøjte (200 mg) til injektion under huden.
Benlysta is available as a powder (120 mg and 400 mg) that is made up into a solution for infusion (drip) into a vein; it is also available as a pre-filled pen and pre-filled syringe (200 mg) for injection under the skin.
Agenturet vurderede, at Benlysta som tillægsbehandling reducerer sygdomsaktiviteten ved SLE.
The Agency considered that Benlysta, used as an add-on treatment, reduced disease activity in SLE.
Den fuldstændige liste over bivirkninger og begrænsninger ved Benlysta fremgår af indlægssedlen.
For the full list of side effects and restrictions of Benlysta, see the package leaflet.
Hos voksne kan Benlysta også gives som injektion under huden (200 mg) én gang om ugen.
In adults, Benlysta can also be given as a 200-mg injection under the skin, once a week.
De hyppigste bivirkninger ved Benlysta (som kan forekomme hos mere end 1 ud af 10 personer) er bakterieinfektioner som f.eks. bronkitis og urinvejsinfektion, diarré og kvalme.
The most common side effects with Benlysta (which may affect more than 1 in 10 people) are bacterial infections, such as bronchitis (infection in the lungs) and infection of the urinary tract (structures that produce or carry urine), diarrhoea and nausea (feeling sick).
Benlysta fås kun på recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i diagnosticering og behandling af systemisk lupus erythematosus (SLE).
Benlysta can only be obtained with a prescription and treatment should only be started and supervised by a doctor who has experience in the diagnosis and treatment of SLE.
Hvordan anvendes Benlysta?
How is Benlysta used?
Hvilke fordele viser studierne, at der er ved Benlysta?
What benefits of Benlysta have been shown in studies?
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Benlysta.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Benlysta have also been included in the summary of product characteristics and the package leaflet.
I det andet studie faldt sygdomsaktiviteten hos 58 % af de patienter, der fik Benlysta, sammenholdt med 44 % af de patienter, der fik placebo.
In the second study, disease activity decreased in 58% of patients treated with Benlysta, compared with 44% of patients who were given placebo.
I det første studie faldt sygdomsaktiviteten hos 43 % af de patienter, der fik Benlysta, sammenholdt med 34 % af de patienter, der fik placebo.
In the first study, disease activity decreased in 43% of patients treated with Benlysta, compared with 34% of patients who were given placebo.
I dette studie faldt sygdomsaktiviteten hos 61 % af de patienter, der fik Benlysta, sammenholdt med 48 % af de patienter, der fik placebo.
The study showed that disease activity decreased in 61% of patients treated with Benlysta, compared with 48% of patients given placebo.
Hvordan virker Benlysta?
How does Benlysta work?
To hovedstudier, der omfattede 1.693 voksne patienter med aktiv SLE, har vist, at infusion af Benlysta som tillægsbehandling er mere effektivt end placebo (et uvirksomt stof) til at reducere sygdomsaktiviteten.
Benlysta given by infusion was shown to be more effective than placebo (a dummy treatment) in reducing disease activity when used as an add-on treatment for SLE in two main studies involving 1,693 adult patients with active SLE.
Benlysta er et lægemiddel, der anvendes som tillægsbehandling hos patienter på 5 år og derover med systemisk lupus erythematosus (SLE).
Benlysta is a medicine used as an add-on treatment in patients aged 5 years and older with systemic lupus erythematosus (SLE), a disease in which the immune system (the body's natural defences) attacks normal cells and tissues, causing inflammation and organ damage.
Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Det Forenede Kongerige) vurderer et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, som gælder både nationalt og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Tyskland og Polen).
This is a procedure when one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Germany and Poland).
Hvad er Pantoprazol Olinka?
What is Pantoprazole Olinka?
Det Europæiske Lægemiddelagentur (EMA) har afsluttet en voldgiftsprocedure som følge af uenighed blandt Den Europæiske Unions medlemsstater om godkendelsen af lægemidlet Pantoprazole Olinka.
The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Olinka.
Agenturets Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Pantoprazole Olinka opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i EU-medlemsstaterne Tyskland og Polen.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Olinka outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the European Union, Germany and Poland.
EU nummer Særnavn Styrke
Invented name Strength
Intravenøs anvendelse Hætteglas 50 ml
10 vials
Denne risiko synes at være højere hos børn.
This risk appears to be higher in children.
Derfor er disse oplysninger af begrænset værdi.
Therefore this information is of limited value.
Ældre patienter (over 65 år)
Elderly patients (over 65 years of age)
Børn under 18 år bør ikke tage denne medicin.
Children aged less than 18 years should not take this medicine.
• Du føler nogen som helst forandringer i din mentale tilstand og velbefindende.
• You feel any change in your mental health and wellbeing.
Modafinil blev først godkendt i EU i Frankrig i juni 1992.
Modafinil was first authorized in the EU in France, in June 1992.
Misbrug og ulovlig brug udgjorde mindre end 3 % af onlinemeddelelserne.
Misuse and illicit use accounted for less than 3% of posted messages online.
Det er på nuværende tidspunkt godkendt i 21 lande i Europa, og de godkendte indikationer er forskellige i medlemsstaterne.
It is currently licensed in 21 countries in Europe, and the approved indications vary between Member States.
Der blev også noteret forbedringer i de subjektive målinger.
Improvements were also noted in the subjective measurements.
Det bemærkes dog, at dosisresponsprofilen ikke synes at være lineær.
It is however noted that the dose-response profile does not seem to be linear.
Selvmordsrelateret adfærd
Suicide-related behaviour
Aggressiv eller fjendtlig adfærd
Aggressive or hostile behaviour
Dataene skal indsendes én gang og er tilgængelige fra investigatorerne.
Data should be submitted once it is available from the investigators.
Da udvalgets vurdering af sikkerhedsoplysningerne ikke ændredes efter revurderingen, forblev produktinformationen uændret.
As the Committee's assessment of the safety information did not change following re-examination, the Product Information remained unchanged.
• Opmærksomhed på din hjerterytme, hvilken kan være hurtigere end normalt.
• Awareness of your heart beat, which may be faster than normal.
Samlet risk/benefit-vurdering
Overall benefit/risk assessment
Det store antal spontane indberetninger synes at understøtte denne forbindelse.
The large number of spontaneous reports seems to support this association.
Almindelig: nedsat appetit
Common: decreased appetite
Stop med at tage medicinen og fortæl straks din læge, hvis
Stop taking this medicine and tell your doctor straight away if
CHMP's videnskabelige rådgivende gruppe (Scientific Advisory Group - SAG) blev også hørt.
The CHMP Scientific Advisory Group (SAG) was also consulted.
Virkningen på langt sigt er heller ikke påvist.
The efficacy in the long term has also not been demonstrated.
Tre af disse havde fatalt udfald, og for de fleste kunne kausalitet ikke udelukkes.
Three of these had a fatal outcome, and for the majority, causality could not be excluded.
Der sås statistisk signifikante forskelle i de subjektive parametre (ESS og CGI-C).
Statistically significant differences were seen in the subjective parameters (ESS and CGI-C).
Off label-anvendelse
Off label use
Det er meningen, at undersøgelsen indledes i september 2010, og at den endelige rapport indsendes i fjerde kvartal 2011.
The study is intended to be initiated in September 2010 and the final report will be submitted in 4Q2011.
• Fejlfortolkning af risiciene i forbindelse med modafinil
• Misinterpretation of the risks associated to modafinil
Udvalget fandt, at yderligere risikominimeringsforanstaltninger ikke vil afhjælpe denne betænkelighed tilstrækkeligt, da risikoens størrelse ikke er fuldt ud fastlagt.
The Committee considered that further risk minimisation measures would not adequately address the concern as the magnitude of the risk is not fully determined.
Men virkningen er lille og afspejler ikke nødvendigvis en klinisk signifikant fordel.
However the effect size is small and does not necessarily reflect a clinically significant benefit.
Brug ikke denne medicin efter den udløbsdato, der står på blisterkortet og den ydre pakning efter ”Exp”.
Do not take this medicine after the expiry date which is stated on the blister strip and the outer pack after ‘Exp'.
Det vil blive overvejet yderligere at anvende databaser i andre EU-lande, f.eks. Institute for Drug Outcomes Research (PHARMO) i Holland og Cegedim i Frankrig.
Further consideration will be given to the use of databases in other EU countries, such as the Institute for Drug Outcomes Research (PHARMO) in the Netherlands and Cegedim in France.
• Taleproblemer.
• Speech problems.
Nøglebudskaberne er aftalt med CHMP, og hver medlemsstat sørger for, at de relevante oplysninger medtages i oversættelsen til deres nationale sprog.
The key messages have been agreed with CHMP and each Member State will ensure that the relevant information is included in the translation in their National Language, as applicable.
Diagnosen narkolepsi bør stilles i henhold til guideline for International Klassifikation af Søvnlidelser (ICSD2).
A diagnosis of narcolepsy should be made according to the International Classification of Sleep Disorders (ICSD2) guideline.
Tag denne indlægsseddel og resten af tabletterne med.
Take this leaflet and any remaining tablets with you.
Disse forskelle er statistisk signifikante, men meget små, og derfor sættes der spørgsmålstegn ved den kliniske signifikans.
These differences, although statistically significant, are very small and therefore its clinical significance is questioned.
• Sukkersyge (diabetes) med forhøjet blodsukker.
• Diabetes with increased blood sugar.
• Udvalget behandlede indbringelsen i henhold til artikel 31 i Rådets direktiv 2001/83/EF, med senere ændringer, for lægemidler indeholdende modafinil.
• The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing modafinil.
Denne forskel i clearance kompenseres delvist af yngre patienters mindre størrelse og lavere vægt, hvilket resulterer i sammenlignelig eksponering efter administration af sammenlignelige doser.
This difference in clearance is partially offset by the younger patients' smaller size and lower weight which results in comparable exposure following administration of comparable doses.
Søvnighed associeret med narkolepsi er den eneste indikation i alle medlemsstater, hvor lægemidlet er godkendt.
Sleepiness associated with narcolepsy is the only indication approved in all Member States where the product is approved.
I undersøgelse 402 steg MSLT fra 7,6 minutter ved baseline til 8,6 minutter.
In study 402, MSLT increased from 7.6 minutes at baseline to 8.6 minutes.
De kompetente nationale myndigheder, koordineret af referencemedlemsstaten, hvor dette er relevant, skal sikre, at følgende betingelser opfyldes af indehaverne af markedsføringstilladelserne:
National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Monitorering af patienten og klinisk evaluering af behovet for behandling bør foretages regelmæssigt.
Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis.
Note: Dette produktresumé og indlægsseddel er den gyldige version på tidspunktet for Kommissionens beslutning.
Note: This SPC and package leaflet is the version valid at the time of Commission Decision.
En senere gennemgang af MHRA viste yderligere betænkeligheder vedrørende risk/benefit-forholdet for nogle af de indikationer, som der er meget begrænsede data for.
A later review performed by the MHRA revealed additional concerns regarding the benefit-risk balance of some of the indications for which very limited efficacy data exists.
Det er derfor hensigtsmæssigt, at behandling med modafinil altid starter med den laveste anbefalede dosis (200 mg) og kun øges op til 400 mg hos patienter med utilstrækkelig respons.
It is therefore appropriate that treatment with modafinil always starts with the lowest recommended dose (200 mg) and be increased up to 400 mg only in patients with insufficient response.
Derfor blev produktinformationen til modafinil opdateret over hele Europa, så den indeholdt yderligere advarsler.
As a result, the product information for modafinil was updated across Europe to include strengthened warnings.
Tabletterne bør sluges hele.
Tablets should be swallowed whole.
Tabletterne skal sluges hele med vand.
Tablets should be swallowed whole with water.
Det kan synes en lille absolut stigning, men i lyset af den kardiovaskulære risiko i denne population og af, at det er en asymptomatisk følge af behandlingen, kan den ikke ignoreres.
This may seem a small absolute increase but in view of the cardiovascular risk associated to this population, and the fact that it is an asymptomatic consequence of treatment, it cannot be dismissed.
Risk/benefit-forholdet ved denne indikation anses derfor for positivt under normale anvendelsesbetingelser.
The benefit-risk balance in this indication is therefore considered to be positive under the normal conditions of use.
• Hævede hænder eller fødder.
• Swollen hands and feet.
Det skal bemærkes, at ingen af undersøgelserne omfattede en objektiv måling af søvnighed i inklusionskriterierne, og det rejser yderligere spørgsmål med hensyn til, om den korrekte population er rekrutteret.
It should be noted that none of the studies included an objective measurement of sleepiness in the inclusion criteria, which raises additional questions regarding the appropriateness of the population recruited.
Ligesom i narkolepsiundersøgelsen blev der ikke observeret nogen dosis-respons-virkning.
As in the narcolepsy studies, no dose response effect was observed.
Der har dog været indberetninger om, at modafinil anvendes som præstationsfremmende middel.
However, there have been reports of modafinil being used as a performance enhancer.
Det illustreres yderligere af, at patienterne ved undersøgelsens afslutning var tilstrækkeligt søvnige til at opfylde inklusionskriterierne for undersøgelsen (MSLT<6 minutter).
This is further illustrated by the fact that patients at the end of the trial were sufficiently sleepy to meet the entrance criteria for the study (MSLT<6 minutes).
Modafinil anses ikke for at være mutagent eller karcinogent.
Modafinil is not considered to be mutagenic or carcinogenic.
• Unormale blodprøveresultater, som viser, at antallet af din hvide blodlegemer er forandret.
• Abnormal blood test results showing that the numbers of your white blood cells have changed.
Til trods for, at der ikke foreligger en klar definition af multiorganoverfølsomhed, giver indberetninger om allergiske reaktioner, der involverer flere organer (herunder et veldokumenteret tilfælde med fatalt udfald) særligt anledning til bekymring.
Despite the lack of a clear definition of multi-organ hypersensitivity, reports of allergic reactions involving multiple organs (including a well documented case with a fatal outcome) are of particular concern.
Hos patienter i alderen 6-7 år er den estimerede halveringstid ca. 7 timer, men stiger med alderen, indtil den nærmer sig halveringstiden hos voksne (ca. 15 timer).
For patients 6 to 7 years of age, the estimated half-life is approximately 7 hours and increases with increase in age until half-life values approach those in adults (approximately 15 hours).
Det aktive stof i tabletterne er modafinil.
The active ingredient in the tablets is modafinil.
Du kan overveje at få et familiemedlem eller en nær ven til at hjælpe med at holde øje med faresignalerne for depression eller andre ændringer i din adfærd.
You may want to consider asking a family member or close friend to help you look out for signs of depression or other changes in your behaviour.
Patienterne skal informeres om, at modafinil ikke er en erstatning for søvn, og at god søvnhygiejne skal opretholdes.
Patients should be advised that modafinil is not a replacement for sleep and good sleep hygiene should be maintained.
En tidsmæssig forbindelse bidrager også til at bekræfte kausalitet.
Temporal association also contributes to the confirmation of causality.
Desuden var der indberetninger om selvmordstanker, fjendtlighed/aggression og psykotiske episoder.
In addition, there were reports of suicidal ideation, hostility/aggression and psychotic episodes.
I lyset af de sikkerhedsproblemer, der er identificeret i denne gennemgang, anses risikominimerende foranstaltninger dog for at være nødvendige for sikker og effektiv anvendelse af lægemidlet.
However, in view of the safety concerns identified during this review, risk minimisation measures are considered necessary to ensure a safe and effective use of the product.
Efter fire ugers behandling præsenterede personerne i undersøgelse 402 sig stadig med MSLT-værdier under det normale (dvs. 10 minutter).
After 4 weeks of treatment, subjects in study 402 still presented with MSLT values below the normal (i.e. 10 minutes).
• har nyre- eller leverproblemer (du skal tage en lavere dosis).
• Have kidney or liver problems (because you will need to take a lower dose).
De data, der er fremlagt til støtte for denne indikation, omfatter i alt seks patienter, hvoraf mindst to faktisk præsenterede sig med overdreven søvnighed på grund af søvnapnø.
Data presented in support of this indication includes a total of 6 patients, of which at least 2 actually presented with excessive sleepiness due to sleep apnoea.
Når Kommissionens afgørelse er udstedt, skal indehaverne af markedsføringstilladelserne indsende en opdateret version af risikostyringsplanen til de kompetente nationale myndigheder, idet de tager højde for alle anbefalinger fra CHMP under proceduren og inkluderer alle undersøgelser, der er beskrevet som betingelser for markedsføringstilladelsen.
Once the Commission Decision is issued, the MAHs must submit an updated version of the Risk Management Plan to the National Competent Authorities, taking into account all recommendations made by the CHMP during the procedure and including all the studies described as conditions of the marketing authorisation.
Den kliniske relevans af denne forbedring er dog tvivlsom, da patienterne ved undersøgelsens afslutning stadig ville blive karakteriseret som alvorligt syge (alvorlig sygdom ifølge ICSD-1 associeres normalt med MSLTscorer under 5).
However, the clinical relevance of this increase is questionable as, at the end of the study, the patients would still be characterised as severely ill (severe illness according to ICSD-1 is usually associated to MSLT scores below 5).
Dette produktresumé og indlægsseddel repræsenterer derfor ikke nødvendigvis den gældende tekst.
Therefore, this SPC and package leaflet may not necessarily represent the current text.
Når steady-state er nået, synes modafinils farmakokinetiske egenskaber ikke at ændre sig ved fortsat administration i op til et år.
Once steady-state is reached, the pharmacokinetic properties of modafinil do not appear to change with continued administration for up to 1 year.
Da studier med modafinil har vist en risiko for afhængighed, kan muligheden for afhængighed ved længerevarende brug ikke udelukkes.
Whilst studies with modafinil have demonstrated a potential for dependence, the possibility of dependence with long-term use cannot be entirely excluded.
Hovedmetabolitten (40-50% af dosis), modafinilsyre, besidder ingen farmakologisk aktivitet.
The chief metabolite (40 - 50% of the dose), modafinil acid, has no pharmacological activity.