FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Danish: 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).
English: Frequency “not known”: Progressive multifocal leukoencephalopathy (PML) Package Leaflet:
Danish: Hyppighed "ikke kendt": Progressiv multifokal leukoencefalopati (PML) Indlægsseddel:
English: The symptoms of PML may be similar to an MS relapse.
Danish: Symptomerne på PML kan minde om tilbagefald af multipel sklerose.
English: In case of PML is suspected, treatment with fingolimod should be discontinued.
Danish: Ved mistanke om PML skal fingolimod seponeres.
English: Therefore the MAH for Xalatan (latanoprost) should submit a variation within 2 months to update the Package Leaflet as described below (new text underlined).
Danish: 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).
English: Progressive multifocal leukoencephalopathy (PML) has been reported under fingolimod treatment since marketing authorization (see section 4.8).
Danish: Der er eftermarkedsføringen indberettet tilfælde af progressiv multifokal leukoencefalopati (PML) ved behandling med fingolimod (se afsnit 4.8).
English: During routine MRI, physicians should pay attention to PML suggestive lesions.
Danish: Ved rutinemæssig MRskanning skal lægen være opmærksom på forandringer tydende på PML.
English: Package Leaflet:
Danish: Indlægsseddel:
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: SmPC:
Danish: Mave-tarmkanalen
English: Colitis, including microscopic colitis has been reported in patients treated with leflunomide.
Danish: Punkt 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen: Ved behandling med leflunomid er beskrevet colitis, herunder mikroskopisk colitis.
English: This overview was last updated in 07-2019.
Danish: Denne oversigt blev sidst ajourført i 07-2019.
English: Symtuza received a marketing authorisation valid throughout the EU on 21 September 2017.
Danish: Symtuza fik en markedsføringstilladelse med gyldighed i hele EU den 21. september 2017.
English: Other information about Symtuza
Danish: Andre oplysninger om Symtuza
English: 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.
Danish: 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.
English: Symtuza contains four active substances which work in different ways against HIV:
Danish: Symtuza indeholder fire aktive stoffer, der virker mod hiv på forskellige måder:
English: Further information on Symtuza can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/symtuza.
Danish: Yderligere information om Symtuza findes på agenturets websted under: ema.europa.eu/en/medicines/human/EPAR/symtuza.
English: As for all medicines, data on the use of Symtuza are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Symtuza løbende overvåget.
English: Symtuza must not be taken by patients with severely reduced liver function.
Danish: Symtuza må ikke tages af patienter med svært nedsat leverfunktion.
English: 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.
Danish: Det må heller ikke tages med visse lægemidler, der kan reducere effektiviteten af Symtuza, samt lægemidler, der kan øge risikoen for alvorlige bivirkninger.
English: What measures are being taken to ensure the safe and effective use of Symtuza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Symtuza?
English: The active substances in Symtuza have already been shown to be effective when used individually, and combining them in a single tablet simplifies treatment.
Danish: 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.
English: The most common side effects with Symtuza (which may affect more than 1 in 10 people) are diarrhoea, headache and rash.
Danish: De hyppigste bivirkninger ved Symtuza (som kan forekomme hos mere end 1 ud af 10 personer) er diarré, hovedpine og udslæt.
English: Why is Symtuza authorised in the EU?
Danish: Hvorfor er Symtuza godkendt i EU?
English: The European Medicines Agency decided that Symtuza's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Symtuza opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: An overview of Symtuza and why it is authorised in the EU
Danish: En oversigt over Symtuza, og hvorfor det er godkendt i EU
English: What is Symtuza and what is it used for?
Danish: Hvad er Symtuza, og hvad anvendes det til?
English: 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.
Danish: 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.
English: Side effects reported with Symtuza are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Symtuza vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Effectiveness was measured by a reduction in viral load (the amount of HIV-1 in the blood) to less than 50 copies/ml.
Danish: Virkningen blev målt ved en reduktion af virusbelastningen (mængden af hiv-1 i blodet) til under 50 kopier/ml.
English: HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Hiv-1 er et virus, der forårsager erhvervet immundefektsyndrom (aids).
English: 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.
Danish: 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.
English: By blocking protease, Symtuza reduces the amount of HIV-1 in the blood and keeps it at a low level.
Danish: Ved at blokere protease mindsker Symtuza hiv-1-mængden i blodet og holder den nede.
English: 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).
Danish: 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).
English: For more information about using Symtuza, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Symtuza, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: • 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.
Danish: • Cobicistat fungerer som en "booster" for virkningen af darunavir ved at bremse nedbrydningen af darunavir og dermed forlænge dets antivirale aktivitet i kroppen.
English: Symtuza can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Danish: Symtuza fås kun på recept, og behandlingen bør kun iværksættes af en læge med erfaring i behandling af hiv-infektioner.
English: What are the risks associated with Symtuza?
Danish: Hvilke risici er der forbundet med Symtuza?
English: It blocks protease, an enzyme of the virus that allows it to reproduce itself in the cells it has infected.
Danish: Det blokerer protease, et enzym, som virussen producerer, så det kan formere sig i de celler, det har inficeret.
English: Because tenofovir alafenamide is effective at a lower dose than tenofovir disoproxil, Symtuza offers the possibility of reduced side effects.
Danish: Da tenofoviralafenamid er effektivt ved en lavere dosis end tenofovirdisoproxil, giver Symtuza mulighed for færre bivirkninger.
English: Symtuza is available as tablets, each containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Danish: Symtuza findes som tabletter, der hver indeholder 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabin og 10 mg tenofoviralafenamid.
English: Symtuza (darunavir / cobicistat / emtricitabine / tenofovir alafenamide)
Danish: Symtuza (darunavir/cobicistat/emtricitabin/tenofoviralafenamid)
English: 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.
Danish: 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.
English: Symtuza was also as effective as a similar combination medicine containing tenofovir disoproxil in place of tenofovir alafenamide.
Danish: Symtuza var også lige så effektivt som et lignende kombinationslægemiddel, der indeholder tenofovirdisoproxil i stedet for tenofoviralafenamid.
English: For more information on the medicines that should not be taken with Symtuza, see the package leaflet.
Danish: Yderligere information om de lægemidler, der ikke bør tages sammen med Symtuza, fremgår af indlægssedlen.
English: 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.
Danish: Tenofovir er en revers transkriptasehæmmer, hvilket betyder, at det blokerer enzymet revers transkriptase, som virusset har brug for, for at kunne formere sig.
English: How does Symtuza work?
Danish: Hvordan virker Symtuza?
English: • Emtricitabine is also a reverse transcriptase inhibitor and it works in the same way as tenofovir.
Danish: • Emtricitabin er en anden type revers transkriptasehæmmer, der virker på samme måde som tenofovir.
English: Symtuza contains the active substances darunavir, cobicistat, emtricitabine and tenofovir alafenamide.
Danish: Symtuza indeholder de aktive stoffer darunavir, cobicistat, emtricitabin and tenofoviralafenamid.
English: • Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Danish: • Tenofoviralafenamid er et prodrug, der i kroppen omdannes til det aktive stof tenofovir.
English: • Darunavir is a type of antiviral agent called a ‘protease inhibitor'.
Danish: • Det antivirale stof darunavir er en såkaldt proteasehæmmer.
English: 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.
Danish: 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.
English: For the full list of side effects reported with Symtuza, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Symtuza fremgår af indlægssedlen.
English: What benefits of Symtuza have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Symtuza?
English: How is Symtuza used?
Danish: Hvordan anvendes Symtuza?
English: Packaging Content Package size Withdrawal period
Danish: Indgivelsesvej Emballage Indhold Pakningsst ør-relse
English: Strength Pharmaceutical form
Danish: Særnavn Styrke Lægemiddelform Dyrearter , som lægemidlet er beregnet til
English: Route of administration
Danish: Tilbagehold elsestid
English: 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.
Danish: Da sygdommen er meget sjælden, er sikkerhedsdatabasen imidlertid lille, og der forventes ikke at blive registreret sjældne hændelser i løbet af de kliniske studier.
English: Coagadex received a marketing authorisation valid throughout the EU on 16 March 2016.
Danish: Coagadex fik en markedsføringstilladelse med gyldighed i hele EU den 16. marts 2016.
English: As for all medicines, data on the use of Coagadex are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Coagadex løbende overvåget.
English: Further information on Coagadex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Coagadex findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: What measures are being taken to ensure the safe and effective use of Coagadex?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Coagadex?
English: 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.
Danish: 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.
English: 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.
Danish: Det Europæiske Lægemiddelagentur vurderede, at fordelene ved Coagadex opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Coagadex (human coagulation factor X)
Danish: Coagadex (human koagulationsfaktor X)
English: These reactions have not been reported during clinical studies with Coagadex.
Danish: Disse reaktioner er ikke set i kliniske studier med Coagadex.
English: 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.
Danish: 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.
English: Other information about Coagadex
Danish: Andre oplysninger om Coagadex
English: In total, 10 bleeds were reported in the study, of which 4 were treated with Coagadex.
Danish: I studiet blev der rapporteret om i alt 10 blødningshændelser, hvoraf 4 blev behandlet med Coagadex.
English: Factor X deficiency is rare and Coagadex was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 September 2007.
Danish: Faktor X-mangel er sjælden, og Coagadex blev udpeget som "lægemiddel til sjældne sygdomme" den 14. september 2007.
English: Side effects reported with Coagadex are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Coagadex vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: 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.
Danish: 187 blødningsepisoder blev registreret, behandlet og vurderet, og behandlingen med Coagadex blev bedømt som "virkelig god" eller "god" i 98,4 % af tilfældene.
English: An overview of Coagadex and why it is authorised in the EU
Danish: En oversigt over Coagadex, og hvorfor det er godkendt i EU
English: Coagadex has been investigated in one main study involving 16 patients with hereditary factor X deficiency aged 12 to 58 years.
Danish: Coagadex er undersøgt i ét hovedstudie med 16 patienter med arvelig faktor X-mangel i alderen 1258 år.
English: 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.
Danish: 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.
English: Why is Coagadex authorised in the EU?
Danish: Hvorfor blev Coagadex godkendt i EU?
English: 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.
Danish: Coagadex udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af sjældne blødersygdomme.
English: Coagadex is given by injection into a vein.
Danish: Coagadex indgives ved injektion i en blodåre.
English: Patients received Coagadex either to treat any spontaneous bleeding during the treatment period or to prevent bleeding during surgery.
Danish: Patienterne fik Coagadex enten til behandling af spontane blødninger, der opstod i behandlingsperioden, eller som forebyggelse af blødning under operation.
English: The active substance in Coagadex is human factor X isolated from the plasma of blood donors.
Danish: Det aktive stof i Coagadex er human faktor X, der er udvundet af plasma fra bloddonorer.
English: What is Coagadex and what is it used for?
Danish: Hvad er Coagadex, og hvad anvendes det til?
English: 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.
Danish: 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.
English: For the full list of side effects and restrictions with Coagadex, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Coagadex fremgår af indlægssedlen.
English: By replacing the missing factor X, Coagadex helps the blood to clot and gives temporary control of bleeding.
Danish: Ved at erstatte den manglende faktor X hjælper Coagadex blodet med at størkne, så der opnås midlertidig blødningskontrol.
English: A single infusion of Coagadex was sufficient to control each treated bleeding event.
Danish: En enkelt injektion af Coagadex var tilstrækkeligt til at kontrollere de blødningshændelser, der blev behandlet.
English: For 3 minor surgeries during the study, Coagadex was rated as excellent in preventing bleeding episodes.
Danish: Ved 3 mindre operationer, der blev udført i løbet af studiet, blev behandlingen med Coagadex bedømt som virkelig god til at forebygge blødningsepisoder.
English: Patients with hereditary factor X deficiency lack factor X, a protein needed to form the blood clot that stops wounds from bleeding.
Danish: Patienter med arvelig faktor X-mangel mangler faktor X, der er et protein, som er nødvendigt for at danne den blodstørkning, der stopper blødning.
English: Factor X deficiency is a bleeding disorder caused by lack of factor X, a protein needed for normal clotting of the blood.
Danish: Faktor X-mangel er en blødersygdom, der skyldes mangel på faktor X, som er et protein, der bidrager til normal størkning af blodet.
English: What are the risks associated with Coagadex?
Danish: Hvilke risici er der forbundet med Coagadex?
English: Coagadex is a medicine used for the treatment and prevention of bleeding (including during and after an operation) in patients with hereditary factor X deficiency.
Danish: Coagadex er et lægemiddel, der anvendes til behandling og forebyggelse af blødning hos patienter med arvelig faktor X-mangel, bl.a. under og efter en operation.
English: In these patients, blood clots do not form properly, resulting in bleeding that does not stop easily and poor wound healing.
Danish: Hos disse patienter størkner blodet ikke på normal vis, så det er vanskeligt at standse blødning og få sår til at hele.
English: The side effects of Coagadex were considered manageable and of mild or moderate intensity.
Danish: Bivirkningerne ved Coagadex anses for at være lette til moderate og vurderes at kunne håndteres.
English: For more information about using Coagadex, see the package leaflet or contact your doctor or pharmacist.
Danish: Patienterne kan selv injicere Coagadex derhjemme, når de har lært det. For mere information om brug af Coagadex, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation Coagadex contains the active substance human coagulation factor X.
Danish: Yderligere oplysninger om lægemidler til sjældne sygdomme findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation