FrancophonIA/ELRC3.0 huggingface dataset:
English: Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10.These pro- and anti-inflammatory mediators have been implicated in psoriatic arthritis and psoriasis.
Danish: Cyklisk AMP modulerer også niveauet af antiinflammatoriske cytokiner som IL-10.
English: DMARDs N=162
Danish: N = 162
English: DMARDs N=168
Danish: N = 168
English: DMARDs N=169
Danish: N = 169
English: Otezla 10 mg film-coated tablets
Danish: Otezla 10 mg filmovertrukne tabletter
English: The Otezla 30 mg film-coated tablet is a beige, diamond shaped film-coated tablet with “APR” engraved on one side and “30” on the opposite side.
Danish: Otezla 30 mg filmovertrukket tablet er en beige, diamantformet, filmovertrukket tablet med ”APR” graveret på den ene side, og ”30” på den modsatte side.
English: The Otezla 20 mg film-coated tablet is a brown, diamond shaped film-coated tablet with “APR” engraved on one side and “20” on the opposite side.
Danish: Otezla 20 mg filmovertrukket tablet er en brun, diamantformet, filmovertrukket tablet med ”APR” graveret på den ene side, og ”20” på den modsatte side.
English: Brown, diamond shaped 20 mg film-coated tablet of 10 mm length with “APR” engraved on one side and “20” on the opposite side.
Danish: Brun, diamantformet 20 mg filmovertrukket tablet med en længde på 10 mm med ”APR” graveret på den ene side og med ”20” på den modsatte side.
English: Otezla 20 mg film-coated tablets
Danish: Otezla 20 mg filmovertrukne tabletter
English: DMARDs N=167
Danish: N = 167
English: The Otezla 10 mg film-coated tablet is a pink, diamond shaped film-coated tablet with “APR” engraved on one side and “10” on the opposite side.
Danish: Otezla 10 mg filmovertrukket tablet er en lyserød, diamantformet, filmovertrukket tablet med ”APR” graveret på den ene side, og ”10” på den modsatte side.
English: What Otezla contains
Danish: Otezla indeholder:
English: Pink, diamond shaped 10 mg film-coated tablet of 8 mm length with “APR” engraved on one side and “10” on the opposite side.
Danish: Lyserød, diamantformet 10 mg filmovertrukket tablet med en længde på 8 mm, graveret med ”APR” på den ene side og med ”10” på den modsatte side.
English: In a male mouse fertility study, apremilast at oral dosages of 1, 10, 25, and 50 mg/kg/day produced no effects on male fertility; the no observed adverse effect level (NOAEL) for male fertility was greater than 50 mg/kg/day 3-fold clinical exposure).
Danish: I et studie af fertiliteten hos hanmus dannede apremilast ved orale doser på 1, 10, 25 og 50 mg/kg/dag ingen virkning på fertiliteten hos hanhus.
English: Migraine* Tension headache* Headache*
Danish: Spændingshovedpine*
English: In addition, at week 32, subjects who did not achieve a PASI-75 response in ESTEEM 1, or a PASI-50 response in ESTEEM 2, were permitted to use topical psoriasis therapies and/or phototherapy in addition to apremilast 30 mg twice daily treatment.
Danish: Desuden var det efter uge 32 tilladt at anvende topikale psoriasisbehandlinger og/eller lysbehandling ud over behandling med apremilast 30 mg to gange dagligt for personer, der ikke opnåede et PASI-75-respons i ESTEEM 1, eller et PASI-50-respons i ESTEEM 2.
English: Otezla 30 mg film-coated tablets
Danish: Otezla 30 mg filmovertrukne tabletter
English: Endpoint n/m (%)
Danish: N PASIc 75, n (%)
English: What Otezla is and what it is used for What you need to know before you take Otezla How to take Otezla
Danish: Det skal du vide, før du begynder at tage Otezla Sådan skal du tage Otezla Bivirkninger
English: Back pain*
Danish: Hovedpine*
English: Change in Pruritus VASf (mm), mean± SD Change in DLQIg, mean± SD
Danish: gennemsnit± SD Ændring af pruritus VASf
English: • feeling tired
Danish: • træthedsfølelse
English: Response Rate +/- SE (%)
Danish: sPGAd på klaret op eller næsten klaret op, n (%)
English: What Otezla looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: • stomach pain
Danish: • mavesmerter
English: • if they drink alcohol
Danish: • hvis de drikker alkohol
English: Protect other people
Danish: Beskyt andre mennesker
English: Such changes may in part be linked to disease control and life style.
Danish: Sådanne ændringer kan delvis være forbundet med sygdomskontrol og livsstil.
English: N = Number of subjects in each treatment group
Danish: N = Antal personer i hver behandlingsgruppe
English: The table should not be considered exhaustive but is representative of the classes studied.
Danish: Tabellen skal ikke anses for udtømmende, men repræsentativ for de undersøgte klasser.
English: Assessed using a non-inferiority margin of 10%.
Danish: Vurderet med en non-inferioritetsmargen på 10 %.
English: Component of a multipack, can't be sold separately.
Danish: Del af en multipakning - må ikke sælges separat.
English: A similar effect was not seen in rats even at very high systemic exposure.
Danish: En lignende effekt blev ikke set hos rotter, selv ved meget høj systemisk eksponering.
English: Individual components have been investigated in adolescents (12 to 17 years).
Danish: De individuelle komponenter er blevet undersøgt hos unge (12 til 17 år).
English: These reactions have often been transitory.
Danish: Disse bivirkninger har ofte været forbigående.
English: Whether such neurological disorders are transient or permanent is currently unknown.
Danish: Om sådanne neurologiske forstyrrelser er forbigående eller permanente er på nuværende tidspunkt ikke kendt.
English: • if they are overweight.
Danish: • hvis de er overvægtige.
English: pure red cell aplasia
Danish: pure red cell-aplasi
English: • if they have been taking combination therapy for a long time
Danish: • hvis de har fået kombinationsbehandling i lang tid
English: This was supported by the pooled analysis, see Table 3.
Danish: Dette blev understøttet af den sammenlagte analyse, se tabel 3.
English: You need to be aware of the extra risks:
Danish: Du skal være klar over den øgede risiko:
English: Symptoms usually include fever, plus some of the following:
Danish: Symptomerne involverer som regel feber, samt nogle af følgende:
English: Reference should be made to treatment guidelines.
Danish: Der henvises til retningslinjer for behandling.
English: This will allow quick identification of new safety information.
Danish: Dermed kan nye sikkerhedsoplysninger hurtigt identificeres.
English: (Complex binding to polyvalent ions)
Danish: (Kompleksbinding til polyvalente ioner)
English: Effect of human serum
Danish: Virkning af humant serum
English: → Don't drive or operate machinery unless you are sure you're not affected.
Danish: → Du må ikke føre motorkøretøjer eller betjene maskiner, medmindre du er sikker på, at du ikke er påvirket.
English: The safety and efficacy of a dual regimen has not been studied in pregnancy.
Danish: Sikkerhed og virkning af et dobbelt regimen er ikke undersøgt hos gravide.
English: This antiviral response was maintained for 3 to 4 days after the last dose in the 50 mg group.
Danish: Dette antivirale respons blev opretholdt i 3-4 dage efter den sidste dosis hos 50 mg-gruppen.
English: This medicine is not for use in children under 12 years of age, because it has not been studied in these patients.
Danish: Dette lægemiddel må ikke anvendes til børn under 12 år, da det ikke er undersøgt tilstrækkeligt hos disse patienter.
English: This helps maintain the number of CD4 cells in your blood.
Danish: Dette hjælper din krop til at bevare antallet af CD4-celler i dit blod.
English: ATC code: J05AR25
Danish: ATC-kode: J05AR25
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body.
Danish: • svaghed, der starter i hænder og fødder og bevæger sig op ad kroppen.
English: Such infections may have been “silent” and not detected by the weak immune system before treatment was started.
Danish: Sådanne infektioner kan have været "skjult" og ikke være blevet opdaget af det svækkede immunsystem før behandlingens start.
English: The frequency category of rare was estimated based on post-marketing reports.
Danish: Hyppighedskategorien Sjælden blev estimeret på baggrund af rapporter efter markedsføring.
English: The absolute bioavailability of oral lamivudine in adults is approximately 80-85%.
Danish: Den absolutte biotilgængelighed af oral lamivudin hos voksne er ca. 80-85 %.
English: If you miss a dose, take it as soon as you remember.
Danish: Hvis du glemmer en dosis, skal du tage den så snart, du husker det.
English: Antiviral activity in cell culture
Danish: Antiviral aktivitet i cellekultur
English: → Ask your doctor for advice before taking this medicine.
Danish: → Spørg din læge til råds, før du tager dette lægemiddel.
English: Pharmacokinetic parameters are comparable to those reported in adults.
Danish: De farmakokinetiske parametre kan sammenlignes med dem, der rapporteres hos voksne.
English: Reduction of the metformin dose should be highly considered.
Danish: Reduktion i metformindosis bør kraftigt overvejes.
English: If you get any of the following symptoms:
Danish: Hvis du får nogen af følgende symptomer:
English: You may need extra checkups, including blood tests, while you're taking your medicine.
Danish: Du kan have brug for ekstra kontrol, herunder blodprøver, mens du tager din medicin.
English: Co-infection with Hepatitis B or C
Danish: Co-infektion med hepatitis B eller C
English: See section 4 for more information.
Danish: Se punkt 4 for yderligere oplysninger.
English: • abnormal dreams
Danish: • unormale drømme
English: Tell your doctor immediately if you become pregnant or are planning to become pregnant.
Danish: Fortæl det straks til lægen, hvis du bliver gravid, eller hvis du planlægger at blive gravid.
English: → Tell your doctor immediately.
Danish: → Gå straks til lægen.
English: Do not stop taking Dovato without consulting your doctor, as this may harm you and your unborn child.
Danish: Stop ikke med at tage Dovato uden først at tale med lægen, da det kan skade dig og dit ufødte barn.
English: • This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Danish: • Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige "natriumfrit".
English: Clinically significant interaction unlikely.
Danish: Klinisk signifikant interaktion usandsynlig.
English: • if you have moderate or severe liver disease
Danish: • hvis du har moderat eller svær leversygdom
English: There are limited data available on the use of Dovato in patients aged 65 years and over.
Danish: Der er begrænsede data om anvendelse af Dovato hos patienter på 65 år og derover.
English: Pooled analysis also stratified by study.
Danish: Sammenlagt analyse blev også stratificeret efter studie.
English: Tell your doctor if you are taking any of the medicines in the following list:
Danish: Fortæl lægen, hvis du tager nogle af lægemidlerne, der står på følgende liste:
English: The clinical relevance of these findings is unknown.
Danish: Den kliniske relevans af disse fund er ukendt.
English: • if their immune systems are very weak
Danish: • hvis deres immunforsvar er meget svækket
English: Your doctor will review your treatment.
Danish: Lægen vil vurdere din behandling.
English: A similar study was not conducted with lamivudine.
Danish: Der blev ikke udført et lignende studie med lamivudin.
English: →Do not take a double dose to make up for a forgotten dose.
Danish: → Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: • difficulty sleeping (insomnia)
Danish: • problemer med at sove (insomni)
English: Dovato does not cure HIV infection; it keeps the amount of virus in your body at a low level.
Danish: Dovato helbreder ikke hiv-infektion, men det holder mængden af virus i kroppen på et lavt niveau.
English: If you have taken Dovato during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis du har taget Dovato under din graviditet, kan lægen bede om regelmæssige blodprøver og andre diagnostiske tests for at overvåge, hvordan dit barn udvikler sig.
English: Then continue your treatment as before.
Danish: Fortsæt derefter med behandlingen som normalt.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheden er defineret som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: People may be more likely to get this condition:
Danish: Personer, der kan have større risiko for at få denne tilstand:
English: The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Danish: Der kan udvikles symptomer på autoimmune sygdomme flere måneder efter, du begynder at tage medicin til behandling af din hiv-infektion.
English: • The recommended dose of Dovato is one tablet once a day.
Danish: • Den anbefalede dosis Dovato er 1 tablet én gang dagligt.
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 1.
Danish: Påviste og teoretiske interaktioner med udvalgte antiretrovirale lægemidler og ikke-antiretrovirale lægemidler er anført i tabel 1.
English: Dolutegravir and lamivudine are rapidly absorbed following oral administration.
Danish: Dolutegravir og lamivudin absorberes hurtigt efter oral administration.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling for hepatitis B eller C henvises også til den relevante produktinformation for de pågældende lægemidler.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er evidens for forværret leversygdom hos sådanne patienter, skal det overvejes at afbryde eller seponere behandlingen.
English: With this condition, parts of the bone tissue are permanently damaged because of reduced blood supply to the bone.
Danish: Med denne sygdom er dele af knoglevævet permanent beskadiget på grund af nedsat blodtilførsel til knoglerne.
English: Your doctor will monitor the effectiveness of your treatment.
Danish: Lægen vil holde øje med, hvor effektiv din behandling er.
English: There are no data available on the safety of lamivudine when administered to babies less than three months old.
Danish: Der foreligger ingen data om sikkerheden af lamivudin ved administration til spædbørn under 3 måneder.
English: These include:
Danish: Disse tilstande omfatter:
English: The changes are not considered to be clinically relevant and do not reflect a change in glomerular filtration rate.
Danish: Ændringerne anses ikke for at være klinisk relevante og afspejler ikke en ændring i den glomerulære filtreringshastighed.
English: CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Danish: CD4-celler er en type hvide blodceller, der spiller en vigtig rolle, når kroppen skal bekæmpe infektioner.
English: Due to the potential risk of neural tube defects with dolutegravir, Dovato should not be used during the first trimester unless there is no alternative.
Danish: På grund af den potentielle risiko for neuralrørsdefekt med dolutegravir må Dovato ikke anvendes i første trimester, medmindre der ikke er noget alternativ.
English: Don't stop unless your doctor tells you to.
Danish: Du må ikke stoppe, medmindre lægen har sagt det.
English: If you notice any of these symptoms: → Tell your doctor.
Danish: Hvis du bemærker nogen af disse symptomer: → Fortæl det til lægen.
English: Consider more frequent monitoring of HIV-1 viral load when chronic coadministration cannot be avoided.
Danish: Overvej hyppigere monitorering af hiv-1-viral belastning, når kronisk samtidig administration ikke kan undgås.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Dovato in one or more subsets of the paediatric population in the treatment of HIV infection.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Dovato i en eller flere undergrupper af den pædiatriske population ved behandling af hivinfektion.
English: A small amount of the ingredients in Dovato can also pass into your breast milk.
Danish: En lille mængde af indholdsstofferne i Dovato kan også udskilles i din modermælk.
English: Double blind therapy will continue up to week 96, followed by open label therapy up to week 148.
Danish: Dobbeltblindet behandling vil fortsætte op til uge 96 og efterfølges af åben behandling op til uge 148.
English: • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don't stop Dovato without your doctor's advice, as your hepatitis may come back)
Danish: • hvis du tidligere har haft en leversygdom, herunder hepatitis B eller C (hvis du har hepatitis B-infektion, må du ikke stoppe med at tage Dovato uden at have talt med lægen, da din hepatitis kan vende tilbage)
English: Dovato can also affect how some other medicines work.
Danish: Dovato kan også påvirke virkningen af andre lægemidler.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Danish: • hvis de også tager en form for antiinflammatorisk (betændelsesdæmpende) medicin, der kaldes kortikosteroider
English: You need to know about important signs and symptoms to look out for while you're taking Dovato.
Danish: Det er nødvendigt, at du kender vigtige tegn og symptomer, som du skal holde øje med, mens du tager Dovato.
English: Dovato should be used during pregnancy only if the expected benefit justifies the potential risk to the foetus.
Danish: Dovato bør kun anvendes under graviditeten, hvis den forventede fordel vejer tungere end den potentielle risiko for fosteret.
English: • hyperactivity (excessive restlessness and movement)
Danish: • hyperaktivitet (overdreven rastløshed og bevægelse)
English: However, as the mechanism by which dolutegravir may interfere in human pregnancy is unknown, the safety in use during the second and third trimester cannot be confirmed.
Danish: Da den mekanisme, som ligger bag dolutegravirs påvirkning af human graviditet imidlertid er ukendt, kan sikkerhed ved brug i andet og tredje trimester ikke fastslås.
English: Dolutegravir has a terminal half-life of ~14 hours.
Danish: Dolutegravir har en terminal halveringstid på ~14 timer.
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Danish: Disse fund påvirker ikke de aktuelle nationale anbefalinger om at anvende antiretroviral behandling hos gravide med henblik på at undgå vertikal hiv-overførsel.
English: Recommendations concerning coadministration
Danish: Anbefalinger vedrørende samtidig administration
English: Sorbitol solution (3.2 g, 10.2 g, 13.4 g)/Lamivudine
Danish: Sorbitolopløsning (3,2 g, 10,2 g, 13,4 g)/lamivudin
English: In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
Danish: I sjældne tilfælde, når immunsystemet bliver stærkere, kan det også angribe sundt kropsvæv (autoimmune sygdomme).
English: Rare side effects that may show up in blood tests are: • increase in an enzyme called amylase.
Danish: Sjældne bivirkninger, der muligvis kan ses i blodprøver, er: • stigning i et enzym, der kaldes amylase.
English: Inhibition of OAT3 has not been studied in vivo.
Danish: Hæmning af OAT3 er ikke undersøgt in vivo.
English: → Talk to your doctor before using Dovato if any of these apply to you.
Danish: → Kontakt lægen, før du bruger Dovato, hvis noget af dette gælder for dig.
English: Discontinued for lack of efficacy
Danish: Seponeret pga. manglende effekt
English: In these cases the physician should refer to the individual product information for dolutegravir.
Danish: I disse tilfælde henvises lægen til det enkelte produktresumé for dolutegravir.
English: The most frequently reported adverse reactions are headache (3%), diarrhoea (2%), nausea (2%) and insomnia (2%).
Danish: De hyppigste bivirkninger er hovedpine (3 %), diarré (2 %), kvalme (2 %) og insomni (2 %).
English: Signs of osteonecrosis include:
Danish: Symptomerne på osteonekrose omfatter:
English: • swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Danish: • hævelse, nogle gange af ansigtet eller munden (angioødem), hvilket giver vejrtrækningsbesvær
English: Symptoms may include:
Danish: Symptomerne kan omfatte:
English: This is an uncommon reaction (may affect up to 1 in 100 people) in people taking dolutegravir.
Danish: Dette er en ikke almindelig bivirkning (kan forekomme hos op til 1 ud af 100 personer) hos personer, der tager dolutegravir.
English: • liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine)
Danish: • leversvigt (tegnene kan omfatte gulfarvning af huden og det hvide i øjnene eller usædvanligt mørk urin)
English: Lamivudine has not shown any genotoxic activity in the in vivo studies.
Danish: Lamivudin har ikke vist nogen genotoksisk aktivitet i in vivo-studierne.
English: Your doctor may decide to carry out tests to check your liver, kidneys or blood, and may tell you to stop taking Dovato.
Danish: Lægen kan beslutte at foretage undersøgelser for at kontrollere din lever, dine nyrer eller dit blod og vil måske bede dig om at stoppe med at tage Dovato.
English: Dolutegravir is highly bound (> 99%) to human plasma proteins based on in vitro data.
Danish: Dolutegravir er i høj grad bundet (>99 %) til humane plasmaproteiner baseret på in vitro-data.
English: These changes are not clinically significant.
Danish: Disse ændringer er ikke klinisk signifikante.
English: Carcinogenesis and mutagenesis
Danish: Karcinogenese og mutagenese
English: If you are pregnant, think you may be pregnant, or if you are planning to have a baby:
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid:
English: Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
Danish: Derfor bør patienterne holdes under tæt klinisk overvågning af læger med erfaring i behandling af disse hiv-relaterede sygdomme.
English: Baseline CD4+ (cells/ mm3)
Danish: Baseline-CD4+ (celler/mm3)
English: ViiV Healthcare BV Huis ter Heideweg 62 3705 LZ Zeist Netherlands
Danish: ViiV Healthcare BV Huis ter Heideweg 62 3705 LZ Zeist Holland
English: HIV infection is spread by sexual contact with someone who has the infection or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hiv-infektion overføres ved seksuel kontakt med en person, der har infektionen, eller ved overførsel af inficeret blod (f.eks. ved at dele kanyler med andre).
English: Use in adolescents
Danish: Brug til børn og unge
English: Dolutegravir can cause a serious allergic reaction known as a hypersensitivity reaction.
Danish: Dolutegravir kan forårsage en alvorlig allergisk reaktion, som kaldes en overfølsomhedsreaktion.
English: Fosamprenavir/ritonavir decreases dolutegravir concentrations, but based on limited data, did not result in decreased efficacy in Phase III studies.
Danish: Fosamprenavir/ritonavir reducerer koncentrationen af dolutegravir, men baseret på begrænsede data resulterede dette ikke i reduceret effekt i fase III-studier.
English: The safety and efficacy of Dovato in children aged less than 12 years or weighing less than 40 kg have not been established.
Danish: Sikkerhed og virkning af Dovato hos børn under 12 år eller som vejer mindre end 40 kg er ikke blevet fastslået.