FrancophonIA/ELRC3.0 huggingface dataset:
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation CHMP Members' Divergent Positions
Danish: Videnskabelige konklusioner og begrundelse for ændring af betingelserne for markedsføringstilladelserne samt detaljeret redegørelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering)
English: • For CHCs containing chlormadinone, dienogest and nomegestrol, the available data are insufficient to know how the risk compares with the other CHCs.
Danish: • For kombinerede hormonale kontraceptiva indeholdende chlormadinon, dienogest og nomegestrol er de foreliggende data utilstrækkelige til at bestemme risikoen i forhold til de øvrige kombinerede hormonale kontraceptiva.
English: Therefore, on the basis of the available evidence, the PRAC acknowledged that the benefits associated with using a CHC far outweigh the risk of serious adverse events in most women.
Danish: På grundlag af den foreliggende evidens fastslog PRAC derfor, at fordelene ved anvendelse af kombinerede hormonale kontraceptiva hos de fleste kvinder langt overstiger risikoen for alvorlige bivirkninger.
English: • The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, on the efficacy and safety of the combined hormonal contraceptive containing medicinal products, in particular with regards to the risk of thromboembolism.
Danish: • PRAC gennemgik alle foreliggende data fra kliniske undersøgelser, farmakoepidemiologiske undersøgelser, den publicerede litteratur, erfaringer efter markedsføring, herunder markedsføringstilladelsesindehavernes skriftlige besvarelser og mundtlige fremlæggelser, om virkningen og sikkerheden af kombinerede hormonale kontraceptiva, navnlig hvad angår risikoen for tromboemboli.
English: The PRAC reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience, including responses submitted by the marketing authorisation holders (MAHs) in writing and at oral explanations, as well as the views of an ad hoc expert meeting on the efficacy and safety of the CHCs, in particular in relation to the risk of thromboembolism.
Danish: PRAC gennemgik alle foreliggende data fra kliniske undersøgelser, farmakoepidemiologiske undersøgelser, den publicerede litteratur og erfaringer efter markedsføring, herunder markedsføringstilladelsesindehavernes skriftlige besvarelser og mundtlige fremlæggelser, samt udtalelse fra et ad hoc-ekspertmøde om virkningen og sikkerheden af kombinerede hormonale kontraceptiva, herunder risikoen for tromboemboli.
English: Also there are certain hereditary thrombophilic defects that increase the risk.
Danish: Derudover er risikoen øget ved visse arvelige trombofile defekter.
English: It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between CHCs in their relative risk of ATE.
Danish: Risikoen for arteriel tromboemboli (myokardieinfarkt, cerebrovaskulær hændelse) vides ligeledes at være forhøjet ved brug af kombinerede hormonale kontraceptiva, men der var ikke tegn på forskelle mellem de forskellige kombinerede hormonale kontraceptiva i den relative risiko for arteriel tromboemboli.
English: In particular, these medicinal products should be contraindicated in patients with multiple risk factors (overweight, smoking, hypertension, increasing age etc.), in patients after major surgery with prolonged immobilisation and patients with history or hereditary predisposition of venous thrombosis.
Danish: Disse lægemidler bør således være kontraindiceret hos patienter med mere end én risikofaktor (overvægt, rygning, hypertension, stigende alder m.m.), hos patienter, der har gennemgået større operative indgreb med langvarig immobilisering, og hos patienter med tidligere tromboemboli eller familiær disposition for tromboemboli.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
Danish: konkluderede PRAC, at benefit/risk-forholdet fortsat er positivt for lægemidlerne Evra, Ioa og Zoely i indikationen antikonception under forudsætning af de vedtagne kontraindikationer, advarsler og andre ændringer i produktinformationen samt supplerende risikominimeringsforanstaltninger.
English: Having considered all the above, the PRAC concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the inclusion of the restrictions, warnings and other changes to the product information agreed.
Danish: Efter at have taget alt det ovenstående i betragtning konkluderede PRAC, at benefit/risk-forholdet fortsat er positivt for Evra, Ioa og Zoely i indikationen antikonception under forudsætning af de vedtagne kontraindikationer, advarsler og andre ændringer i produktinformationen.
English: The risk of VTE with CHCs differs among products depending on the type of progestogen they contain.
Danish: Risikoen for venøs tromboemboli med kombinerede hormonale kontraceptiva afhænger af den type progestogen, de indeholder.
English: Checking personal and family history of VTE before prescribing combined CHC medicinal products is, therefore, recommended in the product information of the products.
Danish: I produktinformationen for kombinerede hormonale kontraceptiva anbefales det derfor, at der optages personlig og familiær anamnese vedrørende venøs tromboemboli, før produkterne ordineres.
English: Furthermore, proactive information to communicate the outcome of the present review and to highlight the risk of the thromboembolic events through a direct healthcare professional communication (DHPC) was recommended.
Danish: Desuden anbefaledes en direkte henvendelse til sundhedspersoner (DHPC) med proaktiv information om resultatet af denne gennemgang og påpegning af risikoen for tromboemboliske hændelser.
English: Pierre Demolis (FR)
Danish: Bilag IV
English: This summary was last updated in February 2014.
Danish: Dette sammendrag blev senest ajourført i februar 2014.
English: It contains a strain called GM 199.
Danish: Den indeholder stammen GM 199.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Parvoduk on 11/04/2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Parvoduk den 11. april 2014.
English: No side effects have been reported to date.
Danish: Der er hidtil ikke indberettet bivirkninger.
English: Parvoduk is a vaccine.
Danish: Parvoduk er en vaccine.
English: Other information about Parvoduk:
Danish: Andre oplysninger om Parvoduk:
English: No field studies were conducted.
Danish: Der blev ikke udført feltundersøgelser.
English: The vaccine is given to day-old ducklings as an injection under the skin, repeated after 16 days.
Danish: Vaccinen gives til daggamle ællinger som en injektion under huden, der gentages efter 16 dage.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter injektion af lægemidlet, før dyret kan slagtes, og kødet kan anvendes til menneskeføde, eller æg eller mælk kan anvendes til menneskeføde.
English: The withdrawal period for Parvoduk is zero days.
Danish: Tilbageholdelsestiden for Parvoduk er 0 døgn.
English: This was considered acceptable, given the laboratory data and taking into account that the Muscovy duck is a minor species.
Danish: Dette blev anset for acceptabelt i betragtning af laboratoriedataene og af, at moskusand er en mindre betydningsfuld dyreart.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Parvoduk exceed the risks for the approved indication and recommended that Parvoduk be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Parvoduk overstiger risiciene til den godkendte anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Parvoduk.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Danish: Afvejningen af fordele og risici (benefit/risk-forholdet) fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: The effectiveness of Parvoduk was investigated in laboratory studies.
Danish: Virkningerne af Parvoduk blev undersøgt i laboratorieforsøg.
English: What is the risk associated with Parvoduk?
Danish: Hvilken risiko er der forbundet med Parvoduk?
English: Although the weakened virus in Parvoduk has not been shown to pass between birds or to cause disease, all the ducklings in a flock should be vaccinated to reduce the risk of this happening.
Danish: Skønt det svækkede virus i Parvoduk ikke er påvist at kunne overføres mellem fuglene eller fremkalde sygdom, bør alle ællinger i flokken vaccineres for at mindske risikoen herfor.
English: Why has Parvoduk been approved?
Danish: Hvorfor blev Parvoduk godkendt?
English: Growth after exposure to Muscovy duck parvovirus or goose parvovirus was improved in vaccinated ducklings by 70% and 110%, respectively.
Danish: Væksten efter eksponering for parvovirus fra moskusand eller gåseparvovirus var henholdsvis 70 % og 110 % bedre hos de vaccinerede ællinger.
English: Week-old ducklings show a range of signs including death and muscle weakness whilst older ducklings display stunted growth, nervous symptoms and feather abnormalities.
Danish: Ugegamle ællinger udviser en række tegn, herunder dødelighed og muskelsvaghed, mens ældre ællinger udviser nedsat vækst, symptomer fra nervesystemet og abnorm fjerdragt.
English: The laboratory studies showed that, two weeks after vaccination, Parvoduk prevented deaths in the ducklings and reduced damage to organs.
Danish: Laboratorieforsøgene viste, at Parvoduk to uger efter vaccinationen forebyggede dødelighed hos ællingerne og mindskede organskade.
English: In the future, if the animals are exposed to Muscovy duck parvovirus, the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for parvovirus fra moskusand, vil immunsystemet kunne reagere hurtigere.
English: The measure of effectiveness was reduction in death rates, stunting of growth, feather abnormalities and damage to organs seen at post-mortem.
Danish: Effektiviteten blev målt på dødelighed, nedsat vækst, abnorm fjerdragt og organskade konstateret ved obduktion.
English: Derzsy's disease is a similar infection caused by the closely related virus, goose parvovirus.
Danish: Derzsys sygdom er en lignende infektion, der skyldes den nært beslægtede gåseparvovirus.
English: When Parvoduk is given to Muscovy ducks the animals' immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Danish: Når Parvoduk gives til moskusænder, registrerer dyrenes immunsystem virusset som "fremmed” og reagerer ved at danne antistoffer mod det.
English: One-day-old ducklings were given a single injection of Parvoduk and then exposed two weeks later to either Muscovy duck parvovirus or goose parvovirus.
Danish: Daggamle ællinger fik en enkelt injektion af Parvoduk og blev to uger senere udsat for enten parvovirus fra moskusand eller gåse- parvovirus.
English: What is Parvoduk?
Danish: Hvad er Parvoduk?
English: Because goose parvovirus is very similar to Muscovy duck parvovirus, the immune response also provides protection if the animal is exposed to goose parvovirus.
Danish: Da gåseparvovirus stærkt ligner parvovirus fra moskusand, giver immunreaktionen også beskyttelse, hvis dyret udsættes for gåseparvovirus.
English: What is Parvoduk used for?
Danish: Hvad anvendes Parvoduk til?
English: The further study showed that Parvoduk vaccination of ducklings was not counteracted by protective antibodies from their mother.
Danish: Endnu et forsøg viste, at vaccination af ællinger med Parvoduk ikke modvirkedes af beskyttende antistoffer fra moderdyret.
English: The Muscovy duck parvovirus in Parvoduk is alive but it has been attenuated (weakened) so that it does not cause disease.
Danish: Parvovirus fra moskusand i Parvoduk er levende, men svækkede, så de ikke er sygdomsfremkaldende.
English: Parvoduk is available as a suspension and diluent for injection.
Danish: Parvoduk leveres som en injektionsvæske, suspension, med fortyndingsmiddel.
English: How has Parvoduk been studied?
Danish: Hvordan blev Parvoduk undersøgt?
English: Two further studies were carried out to investigate the effects of Parvoduk in ducklings who had inherited protective antibodies against Muscovy duck parvovirus or goose parvovirus from their mother.
Danish: Der blev udført yderligere to undersøgelser af virkningerne af Parvoduk hos ællinger, der fra moderdyret havde fået beskyttende antistoffer mod parvovirus fra moskusand eller mod gåseparvovirus.
English: Parvoduk is a veterinary vaccine that contains live attenuated (weakened) Muscovy duck parvovirus.
Danish: Parvoduk er en veterinær vaccine, der indeholder levende, svækkede parvovirus fra moskusand.
English: Muscovy duck parvovirus (live attenuated)
Danish: Parvovirus fra moskusand (levende, svækket)
English: What benefit has Parvoduk shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Parvoduk?
English: How does Parvoduk work?
Danish: Hvordan virker Parvoduk?
English: Parvoduk is used to protect Muscovy ducks against Muscovy duck parvovirosis and Derzsy's disease.
Danish: Parvoduk anvendes til vaccination af moskusænder mod infektion med parvovirus fra moskusand og Derzsys sygdom.
English: In addition it was shown that Parvoduk remains effective until the ducklings are aged six weeks, which means that the ducklings are protected during the period when they are at risk of Muscovy duck parvovirosis and Derzsy's disease.
Danish: Ællingerne er således beskyttet i den periode, hvor de er udsat for risiko for infektion med parvovirus fra moskusand og Derzsys sygdom.
English: This will help protect them against Muscovy duck parvovirosis.
Danish: Derved opnås bedre beskyttelse mod infektion med parvovirus fra moskusand.
English: Muscovy duck parvovirosis is an infectious disease caused by Muscovy duck parvovirus.
Danish: Dette parvovirus forårsager infektion hos moskusænder.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: MF (EU)-nummer (Særnavn) navn Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: This summary was last updated in 01/2018.
Danish: Dette sammendrag blev sidst ajourført i 012018.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Genvoya on 19 November 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Genvoya den 19. november 2015.
English: The recommended dose is one tablet a day, taken with food.
Danish: Den anbefalede dosis er én tablet om dagen, indtaget sammen med et måltid.
English: Genvoya contains four active substances.
Danish: Genvoya indeholder fire aktive stoffer.
English: The CHMP also considered that combining the medicines in a single tablet simplifies treatment.
Danish: CHMP fandt desuden, at kombinationen af disse lægemidler i én enkelt tablet forenkler behandlingen.
English: This is a summary of the European public assessment report (EPAR) for Genvoya.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Genvoya.
English: The full EPAR for Genvoya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Genvoya findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Genvoya
Danish: Andre oplysninger om Genvoya
English: In a supporting study, patients who were being treated with effective HIV treatment either continued with the same treatment or were switched to Genvoya.
Danish: I en støttende undersøgelse fortsatte de patienter, der var i effektiv HIV-behandling, enten med samme behandling eller skiftede til Genvoya.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Genvoya's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Genvoya opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This reduces the virus's ability to replicate and slows down the spread of infection.
Danish: Dette nedsætter virussets evne til at formere sig og bremser spredningen af infektionen.
English: Further data indicated that Genvoya can be used safely in children as young as 6 years of age.
Danish: Yderligere oplysninger viste, at Genvoya kan anvendes sikkert til børn fra 6 års alderen.
English: Other side effects include abnormal dreams, dizziness, feeling tired, and diarrhoea.
Danish: Andre bivirkninger er abnorme drømme, svimmelhed, træthed og diarré.
English: Genvoya must not be taken with certain other medicines because of the possibility of harmful interactions.
Danish: Genvoya må ikke tages sammen med visse andre lægemidler pga. muligheden for skadelige vekselvirkninger.
English: The medicine can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Danish: Lægemidlet udleveres kun efter recept, og behandlingen bør kun iværksættes af en læge med erfaring i behandling af hiv-infektioner.
English: Cobicistat increases the level of elvitegravir by slowing its breakdown.
Danish: Cobicistat øger koncentrationen af elvitegravir ved at bremse dets nedbrydning.
English: What measures are being taken to ensure the safe and effective use of Genvoya?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Genvoya?
English: It is used in adults and adolescents aged over 12 years whose disease is not expected to be resistant to any of the antiviral substances in Genvoya.
Danish: Lægemidlet anvendes hos voksne og unge over 12 år, hos hvem sygdommen ikke forventes at være resistent mod nogen af virusmidlerne i Genvoya.
English: The most common side effect with Genvoya (which may affect more than 1 in 10 people) is nausea (feeling sick).
Danish: Den hyppigste bivirkning ved Genvoya (som kan forekomme hos op til 1 ud af 10 personer) er kvalme.
English: Genvoya does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Genvoya helbreder ikke HIV-1-infektion eller aids, men kan sinke den skade på immunsystemet og udviklingen af de infektioner og sygdomme, der er forbundet med aids.
English: By blocking reverse transcriptase, Genvoya reduces the amount of HIV-1 in the blood and keeps it at a low level.
Danish: Ved at blokere reverse transcriptase mindsker Genvoya HIV-1-mængden i blodet og holder den på et lavt niveau.
English: After 48 weeks around 90% of patients treated with both Genvoya (800 of 866 patients) and the comparator (784 of 867 patients) had responded to treatment.
Danish: Efter 48 uger havde ca. 90 % af de patienter, der blev behandlet med Genvoya (800 ud af 866 patienter) og sammenligningsproduktet (784 ud af 867 patienter), reageret på behandlingen.
English: It is not intended to provide practical advice on how to use Genvoya.
Danish: Det er ikke en praktisk vejledning i, hvordan Genvoya bør anvendes.
English: For more information about treatment with Genvoya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Genvoya, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Tenofovir alafenamide had a milder effect on the kidney than tenofovir disoproxil.
Danish: Tenofovir alafenamid havde en mildere indvirkning på nyren end tenofovir disoproxil.
English: Genvoya can also be used in children aged over 6 years who cannot tolerate other HIV-1 treatments because of side effects.
Danish: Genvoya kan også anvendes til børn på over 6 år, som ikke kan tåle andre HIV-1-behandlinger på grund af bivirkningerne.
English: Why is Genvoya approved?
Danish: Hvorfor blev Genvoya godkendt?
English: What is Genvoya and what is it used for?
Danish: Hvad er Genvoya, og hvad anvendes det til?
English: The infection was considered to have responded to treatment if the viral load in the patient's blood was less than 50 of HIV-1 RNA copies/ml.
Danish: Behandlingen blev anset for at have virket (patienten havde responderet), hvis virusbelastningen i patientens blod var mindre end 50 HIV-1-RNA-kopier/ml.
English: Genvoya is available as tablets, each containing 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Danish: Genvoya fås som tabletter, der indeholder 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabin og 10 mg tenofoviralafenamid.
English: Genvoya's side effects were similar to those of the individual medicines.
Danish: Bivirkningerne ved Genvoya svarede til bivirkningerne ved de enkelte lægemidler.
English: The main measure of effectiveness was based on the reduction of the amount of HIV-1 in the blood.
Danish: Det vigtigste mål for behandlingens virkning var mindskelsen i mængden af HIV-1virus i blodet.
English: Three of the active substances, elvitegravir, cobicistat and emtricitabine have already been shown to be effective.
Danish: Tre af de aktive stoffer, elvitegravir, cobicistat og emtricitabin, er allerede påvist at være effektive.
English: In another study, Genvoya was given to adolescents aged 12 to 18 years with HIV-1 infection who had not been treated previously.
Danish: I en anden undersøgelse blev Genvoya givet til unge mellem 12 og 18 år med HIV-1-infektion, der ikke tidligere var blevet behandlet.
English: By blocking an enzyme called integrase, elvitegravir stops the virus's genetic material from integrating into the genetic material of the cells it has infected.
Danish: Ved at blokere enzymet integrase forhindrer elvitegravir virussets genetiske materiale i at blive indbygget i det genetiske materiale i de celler, det har inficeret.
English: What are the risks associated with Genvoya?
Danish: Hvilke risici er der forbundet med Genvoya?
English: Genvoya was investigated in two main studies involving 1,733 adults infected with HIV-1 who had not been treated previously.
Danish: Genvoya var genstand for to hovedundersøgelser, hvori der deltog 1 733 voksne, som var smittet med HIV-1, men ikke tidligere var blevet behandlet.
English: The viral load was reduced to less than 50 copies/ml after 24 weeks in 90% (45 of 50) of patients.
Danish: Virusbelastningen blev efter 24 uger mindsket til under 50 kopier/ml hos 90 % (45 af 50) af patienterne.
English: They block the activity of reverse transcriptase, a virus enzyme that allows HIV-1 to replicate in the cells it has infected.
Danish: De virker ved at blokere virussets enzym reverse transcriptase, der gør det muligt for HIV-1 at formere sig i de celler, det har smittet.
English: The fourth, tenofovir alafenamide, is effective at a lower dose than the established medicine tenofovir disoproxil and offers the possibility of reduced side effects.
Danish: Det fjerde, tenofoviralafenamid, er effektivt ved lavere dosis end det almindelig anerkendte lægemiddel tenofovirdisoproxil og giver mulighed for færre bivirkninger.