natgillin/translations-raw huggingface dataset:
Uddannelsesmateriale til læger skal ajourføres med denne risiko, og PML skal desuden overvåges tæt i fremtidige PSUR'er.
The prescriber's guide should be updated with this risk and PML should also be closely monitored in future PSURs.
Leflunomid - colitis (EPITT nr. 18189)
Leflunomide - Colitis (EPITT no 18189)
PRAC vedtog at søge rådgivning fra den videnskabelige rådgivende gruppe (SAG) vedrørende risikofaktorer og overvågning (f.eks. MR-skanning, JCV- (John Cunningham-virus) status og CD4+/CD8+ forhold) hos patienter behandlet med fingolimod med henblik på mulighederne for at forbedre prognosen hos tidligt diagnosticerede patienter og udpege patienter med risiko for PML.
The PRAC agreed to ask for a scientific advisory group (SAG) advice regarding the risk factors and the monitoring (e.g. MRI, JCV status, CD4+/CD8+ ratio) of the patients treated with fingolimod, in order to advise on possibilities to improve the prognosis of the patients diagnosed early, and to identify patients at risk of developing PML.
Indehaveren af markedsføringstilladelsen skal desuden fortsat overvåge hændelser med øjenirritation og forelægge ajourførte data i den næste PSUR.
Furthermore, the MAH should continue to monitor events of eye irritation and present updated data in the next PSUR.
Hyppighed "almindelig": Colitis, herunder mikroskopisk colitis såsom lymfocytær colitis, kollagenøs colitis.
Frequency ‘common': Colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis.
Efter gennemgang af den foreliggende evidens fra spontane indberetninger, EudraVigilance og litteraturen, finder PRAC, at patienter i behandling med Xalatan bør advares om vigtigheden af at søge lægehjælp, hvis de oplever kraftig øjenirritation.
Having considered the available evidence from spontaneous reports, EudraVigilance and the literature, the PRAC considers that patients receiving Xalatan should be warned about the importance of seeking medical advice if they experience excessive eye irritation.
Ikke kendt (hyppigheden kan ikke bedømmes ud fra de forhåndenværende data) Risiko for den sjældne hjernebetændelse progressiv multifokal leukoencefalopati (PML).
Not known (frequency cannot be estimated from the available data) Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML).
Natalizumab - anæmi (EPITT nr. 18137)
Natalizumab - Anaemia (EPITT no 18137)
Efter gennemgang af den foreliggende evidens, herunder data fra indehaveren af markedsføringstilladelsen, og i betragtning af, at progressiv multifokal leukoencefalopati (PML) er en kompleks sygdom, som kan tage længere tid om at give kliniske symptomer, har PRAC vedtaget, at der er behov for en ajourføring af produktinformationen.
Having considered the available evidence, including data submitted by the Marketing Authorisation Holder (MAH), and taking into account that Progressive Multifocal Leukoencephalopathy (PML) is a complex disease which may take a prolonged time before becoming clinically symptomatic, the PRAC has agreed that an update of the product information is warranted.
Ved kronisk diarré af ukendt årsag hos patienter i behandling med leflunomid bør patienten udredes med passende diagnostiske procedurer.
In patients on leflunomide treatment presenting unexplained chronic diarrhoea appropriate diagnostic procedures should be performed.
Fingolimod - progressiv multifokal leukoencefalopati (PML) (EPITT nr. 18241)
Fingolimod - Progressive Multifocal Leukoencephalopathy (PML) (EPITT no 18241)
Indehaveren af markedsføringstilladelse for fingolimod skal derfor inden for to måneder indsende en variation om ændring af produktinformationen som beskrevet nedenfor (ny tekst er understreget), og tilføjelse af PML i risikostyringsplanen som en vigtig konstateret risiko (under risiko for infektioner).
Therefore, the MAH for fingolimod should submit a variation within 2 months, to amend the product information as described below (new text underlined) and to include PML in the RMP as an important identified risk (under the risk of infections).
Hyppighed "ikke kendt": Progressiv multifokal leukoencefalopati (PML) Indlægsseddel:
Frequency “not known”: Progressive multifocal leukoencephalopathy (PML) Package Leaflet:
Symptomerne på PML kan minde om tilbagefald af multipel sklerose.
The symptoms of PML may be similar to an MS relapse.
Ved mistanke om PML skal fingolimod seponeres.
In case of PML is suspected, treatment with fingolimod should be discontinued.
Indehaveren af markedsføringstilladelsen for Xalatan (latanoprost) skal derfor inden 2 måneder indsende en ansøgning om ajourføring af indlægssedlen som beskrevet nedenfor (ny tekst er understreget).
Therefore the MAH for Xalatan (latanoprost) should submit a variation within 2 months to update the Package Leaflet as described below (new text underlined).
Der er eftermarkedsføringen indberettet tilfælde af progressiv multifokal leukoencefalopati (PML) ved behandling med fingolimod (se afsnit 4.8).
Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment since marketing authorization (see section 4.8).
Ved rutinemæssig MRskanning skal lægen være opmærksom på forandringer tydende på PML.
During routine MRI, physicians should pay attention to PML suggestive lesions.
Indlægsseddel:
Package Leaflet:
PRAC har gennemgået den foreliggende evidens fra kliniske undersøgelser (colitis beskrevet med en hyppighed på 1 % til <3 % i behandlingsarmen), fra spontane tilfælde, herunder indberettede tilfælde med positiv reaktion ved ophør af provokation og reprovokation samt støttende beskrivelser i litteraturen.
Having considered the available evidence from clinical trials (colitis reported in 1% to <3% in treatment arm), from spontaneous cases including reported positive de-challenge and re-challenge cases as well as supporting reports in literature, the PRAC has agreed that the MAH(s) of leflunomidecontaining products should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Foranlediget af data indsendt af markedsføringstilladelsesindehaveren og på grundlag af evidens fra tilfælde i EudraVigilance og i litteraturen skal markedsføringstilladelsesindehaveren for Tysabri inden 60 dage indsende en variation mhp.
Having considered the data submitted by the MAH, as well as the evidence from EudraVigilance cases and the literature, the MAH of Tysabri should submit a variation within 60 days to add “anaemia” and “haemolytic anaemia” to section 4.8 of the SmPC and to update the Package Leaflet accordingly.
Mave-tarmkanalen
SmPC:
Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen: Ved behandling med leflunomid er beskrevet colitis, herunder mikroskopisk colitis.
Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
Denne oversigt blev sidst ajourført i 07-2019.
This overview was last updated in 07-2019.
Symtuza fik en markedsføringstilladelse med gyldighed i hele EU den 21. september 2017.
Symtuza received a marketing authorisation valid throughout the EU on 21 September 2017.
Andre oplysninger om Symtuza
Other information about Symtuza
Samlet set opnåede 75 % (77 ud af 103) af de patienter, der tog Symtuza, denne reduktion efter 24 ugers behandling, hvilket modsvarede de 74 % (37 ud af 50 patienter), der opnåede den samme reduktion med sammenligningspræparatet.
Overall, 75% of patients taking Symtuza (77 patients out of 103) achieved this reduction after 24 weeks of treatment, which was similar to the 74% (37 of 50) of patients who achieved it with the comparator.
Symtuza indeholder fire aktive stoffer, der virker mod hiv på forskellige måder:
Symtuza contains four active substances which work in different ways against HIV:
Yderligere information om Symtuza findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/symtuza.
Further information on Symtuza can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/symtuza.
Som for alle lægemidler bliver data vedrørende brugen af Symtuza løbende overvåget.
As for all medicines, data on the use of Symtuza are continuously monitored.
Symtuza må ikke tages af patienter med svært nedsat leverfunktion.
Symtuza must not be taken by patients with severely reduced liver function.
Det må heller ikke tages med visse lægemidler, der kan reducere effektiviteten af Symtuza, samt lægemidler, der kan øge risikoen for alvorlige bivirkninger.
It must also not be taken with certain medicines that can reduce the effectiveness of Symtuza, as well as medicines that can increase the risk of serious side effects.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Symtuza?
What measures are being taken to ensure the safe and effective use of Symtuza?
De aktive stoffer i Symtuza har allerede vist sig at være effektive, når de anvendes enkeltvis, og kombinationen af dem i en enkelt tablet forenkler behandlingen.
The active substances in Symtuza have already been shown to be effective when used individually, and combining them in a single tablet simplifies treatment.
De hyppigste bivirkninger ved Symtuza (som kan forekomme hos mere end 1 ud af 10 personer) er diarré, hovedpine og udslæt.
The most common side effects with Symtuza (which may affect more than 1 in 10 people) are diarrhoea, headache and rash.
Hvorfor er Symtuza godkendt i EU?
Why is Symtuza authorised in the EU?
Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Symtuza opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Symtuza's benefits are greater than its risks and it can be authorised for use in the EU.
En oversigt over Symtuza, og hvorfor det er godkendt i EU
An overview of Symtuza and why it is authorised in the EU
Hvad er Symtuza, og hvad anvendes det til?
What is Symtuza and what is it used for?
Symtuza helbreder ikke hiv-1-infektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
Symtuza does not cure HIV-1 infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
De indberettede bivirkninger ved Symtuza vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Symtuza are carefully evaluated and any necessary action taken to protect patients.
Virkningen blev målt ved en reduktion af virusbelastningen (mængden af hiv-1 i blodet) til under 50 kopier/ml.
Effectiveness was measured by a reduction in viral load (the amount of HIV-1 in the blood) to less than 50 copies/ml.
Hiv-1 er et virus, der forårsager erhvervet immundefektsyndrom (aids).
HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).
Da de enkelte aktive stoffer i Symtuza tidligere har vist sig at være effektive og er godkendt til brug ved behandling for hiv-infektion, blev studierne hovedsagelig gennemført for at vise, at Symtuza producerede de samme mængder af aktive stoffer i blodet som de aktive stoffer, der blev givet separat.
Because the individual active substances of Symtuza have previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Symtuza produced similar levels of active substances in the blood as the active substances given separately.
Ved at blokere protease mindsker Symtuza hiv-1-mængden i blodet og holder den nede.
By blocking protease, Symtuza reduces the amount of HIV-1 in the blood and keeps it at a low level.
Symtuza er et antiviralt lægemiddel til behandling af humant immundefektvirus type 1 (hiv-1) hos voksne og hos unge fra 12 år (som vejer mindst 40 kg).
Symtuza is an antiviral medicine used to treat human immunodeficiency virus type 1 (HIV-1) in adults and adolescents aged from 12 years (and weighing at least 40 kg).
Hvis du ønsker mere information om anvendelsen af Symtuza, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Symtuza, see the package leaflet or contact your doctor or pharmacist.
• Cobicistat fungerer som en "booster" for virkningen af darunavir ved at bremse nedbrydningen af darunavir og dermed forlænge dets antivirale aktivitet i kroppen.
• Cobicistat acts as a ‘booster' to increase the effects of darunavir, by slowing down the breakdown of darunavir and therefore prolonging its antiviral activity in the body.
Symtuza fås kun på recept, og behandlingen bør kun iværksættes af en læge med erfaring i behandling af hiv-infektioner.
Symtuza can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Hvilke risici er der forbundet med Symtuza?
What are the risks associated with Symtuza?
Det blokerer protease, et enzym, som virussen producerer, så det kan formere sig i de celler, det har inficeret.
It blocks protease, an enzyme of the virus that allows it to reproduce itself in the cells it has infected.
Da tenofoviralafenamid er effektivt ved en lavere dosis end tenofovirdisoproxil, giver Symtuza mulighed for færre bivirkninger.
Because tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil, Symtuza offers the possibility of reduced side effects.
Symtuza findes som tabletter, der hver indeholder 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabin og 10 mg tenofoviralafenamid.
Symtuza is available as tablets, each containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Symtuza (darunavir/cobicistat/emtricitabin/tenofoviralafenamid)
Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide)
Desuden blev Symtuza i ét hovedstudie sammenlignet med et andet antiviralt lægemiddel indeholdende darunavir, cobicistat, emtricitabin og tenofovirdisoproxil hos 153 voksne hiv-patienter, som ikke tidligere var blevet behandlet.
In addition, one main study compared Symtuza with another antiviral medicine containing darunavir, cobicistat, emtricitabine and tenofovir disoproxil in 153 adult patients with HIV who had not been previously treated.
Symtuza var også lige så effektivt som et lignende kombinationslægemiddel, der indeholder tenofovirdisoproxil i stedet for tenofoviralafenamid.
Symtuza was also as effective as a similar combination medicine containing tenofovir disoproxil in place of tenofovir alafenamide.
Yderligere information om de lægemidler, der ikke bør tages sammen med Symtuza, fremgår af indlægssedlen.
For more information on the medicines that should not be taken with Symtuza, see the package leaflet.
Tenofovir er en revers transkriptasehæmmer, hvilket betyder, at det blokerer enzymet revers transkriptase, som virusset har brug for, for at kunne formere sig.
Tenofovir is a reverse transcriptase inhibitor, which means that it blocks the activity of the enzyme, reverse transcriptase, that the virus needs to reproduce itself.
Hvordan virker Symtuza?
How does Symtuza work?
• Emtricitabin er en anden type revers transkriptasehæmmer, der virker på samme måde som tenofovir.
• Emtricitabine is also a reverse transcriptase inhibitor and it works in the same way as tenofovir.
Symtuza indeholder de aktive stoffer darunavir, cobicistat, emtricitabin and tenofoviralafenamid.
Symtuza contains the active substances darunavir, cobicistat, emtricitabine and tenofovir alafenamide.
• Tenofoviralafenamid er et prodrug, der i kroppen omdannes til det aktive stof tenofovir.
• Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
• Det antivirale stof darunavir er en såkaldt proteasehæmmer.
• Darunavir is a type of antiviral agent called a ‘protease inhibitor'.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Symtuza.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Symtuza have been included in the summary of product characteristics and the package leaflet.
Den fuldstændige liste over indberettede bivirkninger ved Symtuza fremgår af indlægssedlen.
For the full list of side effects reported with Symtuza, see the package leaflet.
Hvilke fordele viser studierne, at der er ved Symtuza?
What benefits of Symtuza have been shown in studies?
Hvordan anvendes Symtuza?
How is Symtuza used?
Indgivelsesvej Emballage Indhold Pakningsst ør-relse
Packaging Content Package size Withdrawal period
Særnavn Styrke Lægemiddelform Dyrearter , som lægemidlet er beregnet til
Strength Pharmaceutical form
Tilbagehold elsestid
Route of administration
Da sygdommen er meget sjælden, er sikkerhedsdatabasen imidlertid lille, og der forventes ikke at blive registreret sjældne hændelser i løbet af de kliniske studier.
However, given the extreme rarity of the condition, the safety database is small and rare events are not expected to be captured during the clinical studies.
Coagadex fik en markedsføringstilladelse med gyldighed i hele EU den 16. marts 2016.
Coagadex received a marketing authorisation valid throughout the EU on 16 March 2016.
Som for alle lægemidler bliver data vedrørende brugen af Coagadex løbende overvåget.
As for all medicines, data on the use of Coagadex are continuously monitored.
Yderligere information om Coagadex findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Coagadex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
I et studie med 9 børn under 12 år (hvoraf 4 var under 4 år) blev rutinemæssig forebyggende behandling med Coagadex over 6 måneder bedømt som virkelig god til at reducere eller forebygge blødningsepisoder.
In a study with 9 children aged less than 12 years (4 of whom were under4 years of age), a routine preventive treatment with Coagadex over 6 months was rated as excellent in reducing or preventing bleeding episodes.
Det primære mål for effekt var baseret på lægens og patientens vurdering af, hvor godt behandlingen virkede med hensyn til at forebygge og behandle blødningsepisoder.
The main measure of effectiveness was based on the doctor's and patient's assessment of how well the treatment worked in preventing and treating bleeding episodes.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Coagadex?
What measures are being taken to ensure the safe and effective use of Coagadex?
Der kan i sjældne tilfælde ses overfølsomhed/allergiske reaktioner hos patienter, der behandles for blødningsforstyrrelser (kan forekomme hos op til 1 ud af 1.000 behandlede); der kan i nogle tilfælde være tale om svære reaktioner.
Hypersensitivity (allergic) reactions can occur rarely in patients treated for bleeding disorders (in up to 1 patient in 1,000) and can be severe in some cases.
Det Europæiske Lægemiddelagentur vurderede, at fordelene ved Coagadex opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that the benefits of Coagadex are greater than its risks and it can be authorised for use in the EU.
Coagadex (human koagulationsfaktor X)
Coagadex (human coagulation factor X)
Disse reaktioner er ikke set i kliniske studier med Coagadex.
These reactions have not been reported during clinical studies with Coagadex.
Dosis og hyppighed af indsprøjtningerne afhænger af, hvor alvorlig patientens mangel på faktor X er, blødningens omfang, hvor i kroppen blødningen er, samt patientens tilstand og legemsvægt.
The dose and frequency of the injections depend on the severity of the patient's factor X deficiency, the extent and location of the bleeding and the patient's condition and bodyweight.
Andre oplysninger om Coagadex
Other information about Coagadex
I studiet blev der rapporteret om i alt 10 blødningshændelser, hvoraf 4 blev behandlet med Coagadex.
In total, 10 bleeds were reported in the study, of which 4 were treated with Coagadex.
Faktor X-mangel er sjælden, og Coagadex blev udpeget som "lægemiddel til sjældne sygdomme" den 14. september 2007.
Factor X deficiency is rare and Coagadex was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 September 2007.
Bivirkninger rapporteret for Coagadex vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Coagadex are carefully evaluated and any necessary action taken to protect patients.
187 blødningsepisoder blev registreret, behandlet og vurderet, og behandlingen med Coagadex blev bedømt som "virkelig god" eller "god" i 98,4 % af tilfældene.
For the treatment of bleeding, 187 bleeding episodes were recorded and assessed, and treatment with Coagadex was rated as ‘excellent' or ‘good' for 98.4% of bleeding episodes.
En oversigt over Coagadex, og hvorfor det er godkendt i EU
An overview of Coagadex and why it is authorised in the EU
Coagadex er undersøgt i ét hovedstudie med 16 patienter med arvelig faktor X-mangel i alderen 1258 år.
Coagadex has been investigated in one main study involving 16 patients with hereditary factor X deficiency aged 12 to 58 years.
De hyppigste bivirkninger ved Coagadex (der kan forekomme hos op til 1 ud af 10 behandlede) er ømhed eller rødme på injektionsstedet, træthed og rygsmerter.
The most common side effects with Coagadex (which may affect up to 1 in 10 people) are pain or redness at the injection site, fatigue (tiredness), and back pain.
Hvorfor blev Coagadex godkendt i EU?
Why is Coagadex authorised in the EU?
Coagadex udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af sjældne blødersygdomme.
Coagadex can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the treatment of rare bleeding disorders.
Coagadex indgives ved injektion i en blodåre.
Coagadex is given by injection into a vein.
Patienterne fik Coagadex enten til behandling af spontane blødninger, der opstod i behandlingsperioden, eller som forebyggelse af blødning under operation.
Patients received Coagadex either to treat any spontaneous bleeding during the treatment period or to prevent bleeding during surgery.
Det aktive stof i Coagadex er human faktor X, der er udvundet af plasma fra bloddonorer.
The active substance in Coagadex is human factor X isolated from the plasma of blood donors.
Hvad er Coagadex, og hvad anvendes det til?
What is Coagadex and what is it used for?
Agenturet konkluderede, med udgangspunkt i manglen på specifikke behandlingsmuligheder ved faktor X-mangel, at Coagadex er effektivt til at behandle og forebygge blødning hos patienter med denne sygdom.
The Agency considered the lack of specific therapies for factor X deficiency, and concluded that Coagadex was effective at treating and preventing bleeding in patients with the condition.
Den fuldstændige liste over bivirkninger og begrænsninger ved Coagadex fremgår af indlægssedlen.
For the full list of side effects and restrictions with Coagadex, see the package leaflet.
Ved at erstatte den manglende faktor X hjælper Coagadex blodet med at størkne, så der opnås midlertidig blødningskontrol.
By replacing the missing factor X, Coagadex helps the blood to clot and gives temporary control of bleeding.
En enkelt injektion af Coagadex var tilstrækkeligt til at kontrollere de blødningshændelser, der blev behandlet.
A single infusion of Coagadex was sufficient to control each treated bleeding event.
Ved 3 mindre operationer, der blev udført i løbet af studiet, blev behandlingen med Coagadex bedømt som virkelig god til at forebygge blødningsepisoder.
For 3 minor surgeries during the study, Coagadex was rated as excellent in preventing bleeding episodes.
Patienter med arvelig faktor X-mangel mangler faktor X, der er et protein, som er nødvendigt for at danne den blodstørkning, der stopper blødning.
Patients with hereditary factor X deficiency lack factor X, a protein needed to form the blood clot that stops wounds from bleeding.