FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was based on the reduction in viral load (the amount of HIV-1 virus in the blood).
Danish: Det primære mål for virkning var reduktion af virusbelastningen (mængden af hiv-1-virus i blodet).
English: Why is Stribild approved?
Danish: Hvorfor blev Stribild godkendt?
English: Stribild is available as tablets (150 mg elvitegravir/150 mg cobicistat /200 mg emtricitabine/245 mg tenofovir disoproxil).
Danish: Stribild fås som tabletter (150 mg elvitegravir/150 mg cobicistat/200 mg emtricitabin/245 mg tenofovirdisoproxil).
English: Stribild was investigated in two main studies involving 1,422 adult patients with HIV-1 who had not been treated before, where Stribild was compared with other HIV medicines.
Danish: Stribild er vurderet i to hovedundersøgelser med 1 422 voksne patienter med hiv-1, som ikke tidligere var blevet behandlet, hvor Stribild blev sammenlignet med andre hivlægemidler.
English: It is used to treat patients from 12 years of age and weighing at least 35 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Det anvendes til behandling af patienter i alderen 12 år og derover med en vægt på mindst 35 kg, og som er smittet med humant immundefektvirus type 1 (hiv-1, et virus, som forårsager erhvervet immundefektsyndrom (aids)).
English: In patients taking some of the components of Stribild, certain rare but serious side effects have been seen including lactic acidosis (excess lactic acid in the blood) and severe kidney problems that may also affect bones.
Danish: Hos patienter, der tager nogle af komponenterne i Stribild, er der set visse sjældne, men alvorlige bivirkninger, herunder laktatacidose (for meget mælkesyre i blodet) og svære nyreproblemer, som også kan påvirke knoglerne.
English: Patients whose viral load was reduced to less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment were considered to have responded to treatment.
Danish: Patienter, hvis virusbelastning reduceredes til mindre end 50 hiv-1-rna-kopier/ml efter 48 ugers behandling, ansås for at have reageret på behandlingen.
English: Stribild can only be obtained with a prescription and treatment should only be started by a doctor who is experienced in managing HIV infection.
Danish: Stribild udleveres kun efter recept, og behandlingen bør kun iværksættes af en læge med erfaring i behandling af hivinfektioner.
English: Stribild must not be used with several other medicines as it may interact with them, thereby reducing the effectiveness of treatment or increasing the risk of side effects.
Danish: Stribild må ikke bruges sammen med en lang række andre lægemidler, da lægemidlerne kan påvirke hinanden, hvorved behandlingseffekten kan reduceres eller risikoen for bivirkninger øges.
English: For more information about treatment with Stribild, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Stribild, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Stribild?
Danish: Hvilke risici er der forbundet med Stribild?
English: A third study involving 50 adolescents aged 12 to 18 years who had not been previously treated for HIV-1 showed that Stribild was also effective in reducing viral load in this age group; 88% (44 of 50 patients) responded to treatment after 24 weeks, and the response persisted after 48 weeks.
Danish: En tredje undersøgelse med 50 unge i alderen 12-18 år, som ikke tidligere var blevet behandlet for hiv1, viste, at Stribild også var effektivt til at reducere virusbelastningen hos denne aldersgruppe; 88 % (44 ud af 50 patienter) reagerede på behandlingen efter 24 uger, og responsen varede ved efter 48 uger.
English: The European Medicines Agency decided that Stribild's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Stribild opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: By blocking reverse transcriptase as well as integrase, Stribild reduces the amount of HIV-1 in the blood and keeps it at a low level.
Danish: Ved at blokere revers transkriptase og integrase mindsker Stribild hiv-1-mængden i blodet og holder den på et lavt niveau.
English: They block the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows the virus to replicate itself in the body.
Danish: De blokerer aktiviteten af revers transkriptase, et enzym, som produceres af hiv-1, og som gør det muligt for virusset at formere sig i kroppen.
English: Stribild elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil
Danish: Stribild elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxil
English: Stribild must not be used in patients who have previously stopped treatment with tenofovir disoproxil due to kidney toxicity.
Danish: Stribild må ikke anvendes hos patienter, der tidligere har stoppet behandling med tenofovirdisoproxil på grund af nyretoksicitet.
English: The Agency also noted the risk of side effects affecting the kidneys, and recommended that kidney function should be carefully assessed before patients start taking Stribild and should be monitored during treatment.
Danish: Agenturet bemærkede også risikoen for bivirkninger, der påvirker nyrerne, og anbefalede, at nyrefunktionen vurderes nøje før og under behandling med Stribild.
English: Stribild is a medicine that contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Danish: Stribild er et lægemiddel, der indeholder de aktive stoffer elvitegravir, cobicistat, emtricitabin og tenofovirdisoproxil.
English: After 48 weeks, around 88% of patients treated with Stribild (305 out of 348) responded to treatment compared with around 84% of patients treated with the comparator medicine (296 out of 352).
Danish: Efter 48 uger havde behandlingen virket hos ca. 88 % af de patienter, der blev behandlet med Stribild (305 ud af 348), sammenholdt med ca. 84 % af de patienter, der blev behandlet med sammenligningslægemidlet (296 ud af 352).
English: In the first study, involving 715 patients, Stribild was compared with the combination of ritonavir, atazanavir plus a medicine containing emtricitabine and tenofovir disoproxil (which are also contained in Stribild).
Danish: I den første undersøgelse, hvori der deltog 715 patienter, blev Stribild sammenlignet med kombinationen af ritonavir, atazanavir plus et lægemiddel, der indeholdt emtricitabin og tenofovirdisoproxil (som også indgår i Stribild).
English: For practical information about using Stribild, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Stribild, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Tenofovir and emtricitabine are closely related types of antiviral agent called reverse transcriptase inhibitors.
Danish: Tenofovir og emtricitabin er nært beslægtede typer af et virusmiddel, der kaldes revers transkriptasehæmmer.
English: It blocks an HIV-1 enzyme called integrase, which is involved in thevirus's replication, thereby reducing the virus's ability to replicate normally and slowing down its spread.
Danish: Det blokerer et hiv-1-enzym (integrase), der indgår i virussets replikation (formering), hvorved virussets evne til at formere sig normalt nedsættes og spredningen forsinkes.
English: After 48 weeks, around 90% of patients treated with Stribild (316 out of 353) responded to treatment compared with around 87% of patients treated with the comparator treatment (308 out of
Danish: Efter 48 uger havde behandlingen virket hos ca. 90 % af de patienter, der blev behandlet med Stribild (316 ud af 353), sammenholdt med ca. 87 % af de patienter, der blev behandlet med sammenligningslægemidlet (308 ud af 355).
English: In the second study, involving 707 patients, Stribild was compared with a medicine containing efavirenz, emtricitabine and tenofovir disoproxil.
Danish: I den anden undersøgelse, som omfattede 707 patienter, blev Stribild sammenlignet med et lægemiddel indeholdende efavirenz, emtricitabin og tenofovirdisoproxil.
English: In particular, the Agency concluded that the benefits of Stribild in reducing HIV viral load had been clearly shown in studies, and noted that it has the advantage of being taken once per day.
Danish: Stribild med hensyn til reduktion af hivvirusbelastningen var tydeligt påvist i undersøgelser, og at lægemidlet har den fordel, at det kun skal tages én gang om dagen.
English: For the full list of all side effects reported with Stribild, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Stribild fremgår af indlægssedlen.
English: How is Stribild used?
Danish: Hvordan anvendes Stribild?
English: What benefits of Stribild have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Stribild?
English: The most common side effects with Stribild are nausea (feeling sick) and diarrhoea, which can affect more than 1 in 10 people.
Danish: De hyppigste bivirkninger ved Stribild (som optræder hos mere end 1 ud af 10 patienter) er kvalme og diarré.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stribild have also been included in the summary of product characteristics and the package leaflet.
Danish: 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 Stribild.
English: This will cover information on the risk of kidney disease in adults and adolescents and the measures to reduce this risk, including appropriate screening and monitoring of patients.
Danish: Den virksomhed, der markedsfører Stribild, skal sikre, at alle læger, der forventes at ordinere Stribild, får udleveret informationsmateriale med vigtige sikkerhedsoplysninger, f.eks. om risikoen for nyreproblemer hos voksne og unge samt om forholdsregler for at reducere denne risiko, herunder hensigtsmæssig screening og overvågning af patienter.
English: How does Stribild work?
Danish: Hvordan virker Stribild?
English: It is used only in patients who have not received HIV medicines before or whose disease is not expected to be resistant to any of the antiviral agents in Stribild; it should only be used in patients under 18 years if other HIV medicines not including tenofovir disoproxil cannot be used because of side effects.
Danish: Det anvendes kun hos patienter, der ikke tidligere er blevet behandlet med hivlægemidler, eller hvis sygdom ikke forventes at være resistent over for nogen af de antivirale stoffer i Stribild.
English: Cobicistat enhances the effects of elvitegravir, by prolonging the time for which elvitegravir continues to work.
Danish: Cobicistat forstærker virkningen af elvitegravir ved at forlænge den tid, som elvitegravir virker i. Tenofovirdisoproxil er et såkaldt prodrug (forstadium) for tenofovir, der omdannes til det aktive stof tenofovir i kroppen.
English: The European Commission issued a decision on 7 May 2009.
Danish: Europa-Kommissionen traf en afgørelse den 7. maj 2009.
English: Dr Michal Pirożynski (Poland)
Danish: Dr. Michal Pirożynski (Polen)
English: The only difference is that it contains very small amounts of ascorbic acid (an antioxidant).
Danish: Den eneste forskel er, at det indeholder meget små mængder ascorbinsyre (en antioxidant).
English: The CHMP also recommended that the product information for the medicine in Germany be amended.
Danish: CHMP anbefalede desuden, at produktinformationen for lægemidlet i Tyskland blev ændret.
English: The review was carried out under an ‘Article 29' referral1.
Danish: Undersøgelsen blev gennemført i henhold til en ‘artikel 29'-indbringelse
English: 19 February 2009
Danish: 19. februar 2009
English: The German authorities recommended that the medicine should not be authorised for use in children, as no studies had been carried out in this age group.
Danish: De tyske myndigheder anbefalede, at lægemidlet ikke blev godkendt til anvendelse til børn, da der ingen undersøgelser var gennemført i denne aldersgruppe.
English: Dr Barbara Van Zwieten-Boot (the Netherlands)
Danish: Dr. Barbara Van Zwieten-Boot (Nederlandene)
English: The grounds for the referral were a disagreement among Member States on the use of the medicine in adolescents and children (over 6 years of age).
Danish: Begrundelsen for indbringelsen var uenighed blandt medlemsstaterne med hensyn til, hvordan lægemidlet skal anvendes til unge og børn (over 6 år).
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 4 August 2008.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og den tyske lægemiddelmyndighed indbragte sagen for CHMP den 4. august 2008.
English: Referral start date:
Danish: Startdato for indbringelsen:
English: Questions and answers on the referral for Budesonide Sandoz nasal suspension with 32 or 64 microgram per spray
Danish: Spørgsmål og svar vedrørende den indbragte sag om Budesonide Sandoz næsespray, suspension, med 32 eller 64 mikrogram pr. dosis
English: The active substance, budesonide, is a corticosteroid, which is a type of substance that helps to reduce inflammation.
Danish: Det aktive stof, budesonid, er et kortikosteroid, dvs. et stof, der hjælper med til at reducere betændelse.
English: It is used to treat and prevent the symptoms of seasonal allergic rhinitis (allergy to pollen, also known as hayfever) and perennial allergic rhinitis (when the allergy is due to other triggers, such as house dust or animals).
Danish: Det anvendes til forebyggelse og behandling af symptomer på sæsonbundet allergisk rhinitis (pollenallergi, også kendt som høfeber) og tilbagevendende allergisk rhinitis (når allergien fremkaldes af andre faktorer som f.eks. husstøv eller dyr).
English: It can also be used to treat nasal polyps (growths in the lining of the nose).
Danish: Det kan desuden anvendes til behandling af næsepolypper (fremvækster i næseslimhinderne).
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Germany) 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 the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom).
Danish: Det er en procedure, hvor en medlemsstat ("referencemedlemsstaten", i dette tilfælde Tyskland) vurderer et lægemiddel med henblik på at udstede en markedsføringstilladelse, som gælder både nationalt og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Den Tjekkiske Republik, Danmark, Frankrig, Nederlandene, Sverige og Det Forenede Kongerige samt Norge).
English: However, another Member State, the Netherlands, recommended that the medicine should also be authorised for use in children, as the medicine on which it is based, Rhinocort, can be used in this population.
Danish: En anden medlemsstat, Nederlandene, anbefalede derimod, at lægemidlet blev godkendt til børn, da det lægemiddel, det er baseret på (Rhinocort), kan anvendes til denne patientgruppe.
English: 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 Budesonide Sandoz.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har gennemført en voldgiftsprocedure på grund af uenighed blandt EU-medlemsstater angående godkendelsen af lægemidlet Budesonide Sandoz.
English: London, 3 June 2009
Danish: London, den 3. juni 2009 Dok.
English: What is Budesonide Sandoz?
Danish: Hvad er Budesonide Sandoz?
English: Based on evaluation of the currently available data, including the studies carried out to compare the way Budesonide Sandoz is handled by the body to that of Rhinocort, and the scientific discussion within the Committee, the CHMP concluded that the benefits of Budesonide Sandoz outweigh its risks, and that therefore the marketing authorisation for Budesonide Sandoz should be granted in all concerned Member States for patients aged from 6 years.
Danish: På grundlag af vurderingen af de foreliggende oplysninger, herunder undersøgelserne af, hvordan Budesonide Sandoz virker i kroppen i forhold til Rhinocort, og den faglige drøftelse i udvalget, konkluderede CHMP, at fordelene ved Budesonide Sandoz opvejer risiciene, og at der derfor bør udstedes markedsføringstilladelse for Budesonide Sandoz i alle de berørte medlemsstater med anvendelse til patienter på 6 år og derover.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Budesonide Sandoz outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the European Union, the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom.
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved Budesonide Sandoz opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Tyskland og i EU-medlemsstaterne Den Tjekkiske Republik, Danmark, Frankrig, Nederlandene, Sverige og Det Forenede Kongerige samt i Norge.
English: Budesonide Sandoz is almost identical to another medicine authorised in the European Union, Rhinocort.
Danish: Budesonide Sandoz er næsten identisk med et andet lægemiddel kaldet Rhinocort, som allerede er godkendt i Den Europæiske Union.
English: Budesonide Sandoz is an anti-inflammatory medicine.
Danish: Budesonide Sandoz er et antiinflammatorisk lægemiddel.
English: Why was Budesonide Sandoz reviewed?
Danish: Hvorfor blev Budesonide Sandoz vurderet igen?
English: 1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Danish: 1 Sag indbragt med den begrundelse, at der foreligger en potentiel alvorlig risiko for folkesundheden, i henhold til artikel 29 i direktiv 2001/83/EF, med senere ændringer.
English: Sandoz Pharmaceuticals GmbH submitted Budesonide Sandoz to the German medicines regulatory agency for a decentralised procedure.
Danish: Sandoz Pharmaceuticals GmbH indgav ansøgningen for Budesonide Sandoz gennem en decentral procedure til den tyske lægemiddelmyndighed.
English: Company responses provided on: 24 December 2008 Opinion date:
Danish: Dato for virksomhedens svar:
English: Doc.
Danish: Medrapportør:
English: Co-Rapporteur:
Danish: Dato for udtalelsen:
English: This summary was last updated in 06-2011.
Danish: Dette sammendrag blev sidst ajourført i 06-2011.
English: Kentera was more effective than placebo.
Danish: Kentera var mere effektivt end placebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kentera on 15 June 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Kentera den 15. juni 2004.
English: The full EPAR for Kentera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Kentera findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Kentera.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kentera.
English: For the transdermal patches, one patch is used twice a week (every three to four days).
Danish: For de transdermale plastre anvendes ét plaster to gange ugentligt (hver tredje til hver fjerde dag).
English: EPAR summary for the public oxybutynin
Danish: EPAR - sammendrag for offentligheden oxybutynin
English: Other information about Kentera
Danish: Andre oplysninger om Kentera:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Kentera.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Kentera.
English: For more information about treatment with Kentera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kentera, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The Committee therefore decided that the benefits of Kentera gel also outweighed its risks and recommended the approval of the new formulation.
Danish: Udvalget besluttede, at fordelene ved Kentera-gel også opvejede dens risici, og anbefalede godkendelse af den nye formulering.
English: Oxybutynin has been available as a tablet for the treatment of overactive bladder since the 1970s.
Danish: Oxybutynin har været på markedet i tabletform til behandling af overaktiv blære siden 1970'erne.
English: A new application site should be chosen for each new patch so that the same area of skin is not used more than once within a week.
Danish: For hvert nyt plaster skal der vælges et nyt påføringssted, så det samme hudområde ikke anvendes mere end én gang inden for en uge.
English: The active substance in Kentera, oxybutynin, is an anticholinergic medicine.
Danish: Det aktive stof i Kentera, oxybutynin, er et antikolinergt lægemiddel.
English: What is the risk associated with Kentera?
Danish: Hvilken risiko er der forbundet med Kentera?
English: In the other, they were compared with tolterodine capsules (another medicine used to treat urge incontinence) in 361 patients.
Danish: I den anden blev de sammenlignet med tolterodin kapsler (et andet lægemiddel, der anvendes til behandling af urgeinkontinens) hos 361 patienter.
English: Kentera is a medicine that contains the active substance oxybutynin.
Danish: Kentera er et lægemiddel, der indeholder det aktive stof oxybutynin.
English: In one study, they were compared with placebo (a dummy treatment) in 520 patients.
Danish: I den ene undersøgelse blev de sammenlignet med placebo (en virkningsløs behandling) hos 520 patienter.
English: Kentera should not be used in people who may be hypersensitive (allergic) to oxybutynin or any of the other ingredients.
Danish: Kentera må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for oxybutynin eller andre af indholdsstofferne.
English: Different application sites should be chosen, so that the same area of skin is not used on consecutive days.
Danish: Der bør vælges forskellige påføringssteder, så det samme hudområde ikke anvendes flere dage i træk.
English: The main measure of effectiveness was the change in the number of daily incontinence episodes after 12 weeks of treatment.
Danish: Det primære effektmål var ændringen i antallet af daglige episoder med ufrivillig vandladning efter 12 ugers behandling.
English: The CHMP had first evaluated Kentera transdermal patches and concluded that their effectiveness was similar to that of the oxybutynin tablets already on the market and that the benefits outweighed the risks.
Danish: CHMP havde først evalueret Kentera transdermale plastre og konkluderede, at deres virkning svarede til virkningen af de oxybutynin-tabletter, der i forvejen var på markedet, og at fordelene opvejede risiciene.
English: For the gel, the recommended daily dose is 4 mg of oxybutynin once a day, which corresponds to one gram of gel delivered using a metering pump or to the content of one sachet.
Danish: For gelen er den anbefalede daglige dosis 4 mg oxybutynin én gang om dagen, hvilket svarer til ét gram gel påført ved hjælp af en doseringspumpe eller til indholdet af én pose.