FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of side effects and restrictions with Cablivi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Cablivi fremgår af indlægssedlen.
English: Cablivi is started with a dose of 10 mg given by injection into a vein before plasma exchange.
Danish: Cablivi påbegyndes med en dosis på 10 mg givet ved injektion i en blodåre før plasmaudskiftning.
English: Treatment is continued with 10 mg daily given by injection under the skin in the belly after daily plasma exchange and continued for 30 days after daily plasma exchange is stopped.
Danish: Behandlingen fortsættes med en daglig injektion af 10 mg under huden på maven efter daglig plasmaudskiftning og i 30 dage efter ophør af daglig plasmaudskiftning.
English: Two main studies have investigated the effectiveness of Cablivi in patients with aTTP who required plasma exchange to treat their condition.
Danish: Der er gennemført to studier, der undersøgte virkningen af Cablivi hos patienter med aTTP, som havde behov for plasmaudskiftning til behandling af deres sygdom.
English: The Agency considered that, in patients with aTTP, Cablivi combined with plasma exchange and immunosuppression can reduce the time it takes for platelet counts to return to the normal range, which is associated with shorter duration of plasma exchange treatment and shorter stay in intensive care facility.
Danish: Agenturet fandt, at Cablivi i kombination med plasmaudskiftning og immunsupprimering hos patienter med aTTP kan reducere den tid, som det tager for blodpladetallet at vende tilbage til normalområdet, hvilket er forbundet med kortere tids behandling med plasmaudskiftning og kortere tids ophold på en intensiv afdeling.
English: Cablivi is a medicine used for treating adults who have an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a blood clotting disorder.
Danish: Cablivi er et lægemiddel til behandling af voksne, der oplever en episode af erhvervet trombotisk trombocytopenisk purpura (aTTP; en blodstørkningsforstyrrelse).
English: The second study, involving 145 patients, measured how long it took for the platelet count to return to the normal range and for sufficient improvement in the condition to allow daily plasma exchange to be stopped within 5 days.
Danish: Det andet studie havde deltagelse af 145 patienter og undersøgte, hvor lang tid det tog for blodpladetallet at vende tilbage til normalområdet, og hvor lang der gik, før der var opnået en tilstrækkelig forbedring af tilstanden til, at plasmaudskiftningen kunne ophøre inden for 5 dage.
English: In the first study, involving 75 patients, platelet counts returned to the normal range after 3 days on average in patients treated with Cablivi, compared with nearly 5 days in those receiving placebo (a dummy treatment).
Danish: I det første studie, som omfattede 75 patienter, vendte blodpladetallene tilbage til normalområdet efter gennemsnitligt 3 dage hos patienter, der fik Cablivi, sammenholdt med næsten 5 dage hos patienter, der fik placebo (ikke-aktivt stof).
English: The study found that platelet count was likely to return to the normal range more quickly in patients treated with Cablivi compared with those receiving placebo.
Danish: Det blev påvist, at blodpladetallet sandsynligvis ville vende hurtigere tilbage til normalområdet hos patienter, der blev behandlet med Cablivi, end hos dem, der fik placebo.
English: How is Cablivi used?
Danish: Hvordan anvendes Cablivi?
English: What benefits of Cablivi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Cablivi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cablivi 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 Cablivi.
English: How does Cablivi work?
Danish: Hvordan virker Cablivi?
English: In patients with aTTP, levels of a substance called von Willebrand factor are increased.
Danish: Patienter med aTTP har et øget niveau af et stof, der hedder von Willebrand-faktor, og som får blodplader til at klæbe sammen og danne blodpropper.
English: Then continue your treatment as before.
Danish: Fortsæt herefter din behandling som før.
English: There may be more than one in the bottle.
Danish: Der kan være flere af dem i flasken.
English: This will help by:
Danish: Dette hjælper med at:
English: Blood tests may also show:
Danish: Blodprøver kan også vise:
English: 3; these characteristics were similar between treatment groups.
Danish: 3; disse karakteristika var sammenlignelige mellem behandlingsgrupperne.
English: These medicinal products include, but are not limited to the following:
Danish: Disse lægemidler omfatter, men er ikke begrænset til, følgende:
English: • This medicine can be taken with food or between meals.
Danish: • Denne medicin kan tages med mad eller mellem måltiderne.
English: Physicians are encouraged to register patients in this registry.
Danish: Læger tilskyndes til at registrere patienterne i dette register.
English: The recommended dose is 1 tablet once a day.
Danish: Den anbefalede dosis er 1 tablet en gang dagligt.
English: Talk to your doctor about what you can do to avoid infecting other people.
Danish: Tal med lægen om, hvad du kan gøre for at undgå at smitte andre mennesker.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Danish: Forholdsregler med henblik på at forebygge overførsel skal træffes i overensstemmelse med nationale retningslinjer.
English: The patient should not take 2 doses at one time.
Danish: Patienten må ikke tage 2 doser på en gang.
English: The following pack sizes are available:
Danish: Følgende pakningsstørrelser er tilgængelige:
English: Consistent results were seen for the comparison at Study Week 24 in each treatment group.
Danish: Der sås overensstemmende resultater for sammenligningen ved studiets uge 24 i hver behandlingsgruppe.
English: • Do not use this medicine after the expiry date which is stated on the bottle after EXP.
Danish: • Tag ikke lægemidlet efter den udløbsdato, der står på flasken efter EXP.
English: A similar effect was not seen in rats even at very high systemic exposure.
Danish: Der blev ikke set en tilsvarende virkning hos rotter, selv ved meget høj systemisk eksponering.
English: Binding to plasma protein is low.
Danish: Graden af binding til plasmaprotein er lav.
English: Treatment results are shown in Table 5.
Danish: Behandlingsresultaterne er vist i tabel 5.
English: HIV is spread by contact with blood or through sexual contact with a person with HIV.
Danish: Hiv spredes ved kontakt med blod fra eller via seksuel kontakt med en person med hiv.
English: Do not take Delstrigo if the above applies to you.
Danish: Tag ikke Delstrigo, hvis ovenstående gælder for dig.
English: Discontinued study for Other Reasons
Danish: Udtrådt af studie af andre grunde
English: Talk with your doctor about the best way to feed your baby.
Danish: Tal med lægen om den bedste måde at give dit spædbarn mad på.
English: It belongs to a group of medicines called ‘antiretroviral medicines'.
Danish: Det tilhører en gruppe af lægemidler, der kaldes ‘antiretrovirale lægemidler'.
English: These tumours are unlikely to be of relevance to humans.
Danish: Det er ikke sandsynligt, at disse tumorer er af relevans for mennesker.
English: Co-administration should be avoided.
Danish: Samtidig administration skal undgås.
English: Following oral administration, lamivudine is rapidly absorbed and extensively distributed.
Danish: Efter oral administration absorberes lamivudin hurtigt og fordeles i høj grad.
English: Worsening of hepatitis B infection
Danish: Forværring af hepatitis B-infektion
English: No Virologic Data Within the Time Window
Danish: Ingen virologiske data inden for tidsvinduet
English: Delstrigo contains the active substances:
Danish: Delstrigo indeholder de aktive stoffer:
English: The clinical relevance of this finding is unknown.
Danish: Den kliniske relevans af dette er ukendt.
English: *The 95 % CI for the treatment difference was calculated using stratum-adjusted Mantel-Haenszel method.
Danish: *95 % CI for behandlingsforskellen blev kalkuleret ved hjælp af den stratum-justerede Mantel-Haenszel-metode.
English: Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time.
Danish: Dit immunforsvar kan blive stærkere og begynde at bekæmpe infektioner, der har været skjult i din krop i lang tid.
English: Therefore, cross-resistance among these NRTIs may occur in patients whose virus harbours the K65R substitution.
Danish: Derfor kan der forekomme krydsresistens mellem disse NRTIer hos patienter, hvis virus har K65R-substitutionen.
English: Your doctor may need to do additional tests to check your bones.
Danish: Lægen kan blive nødt til at foretage yderligere undersøgelser for at kontrollere dine knogler.
English: This should be considered when assessing a patient's ability to drive or operate machinery.
Danish: Dette skal tages i betragtning ved vurdering af en patients evne til at føre motorkøretøj eller betjene maskiner.
English: Week 48 and 96 outcomes for DRIVE-FORWARD and DRIVE-AHEAD are provided in Table 4.
Danish: Resultaterne i uge 48 og uge 96 for DRIVE-FORWARD og DRIVE-AHEAD er vist i tabel 4.
English: Do not stop taking this medicine without first talking to your doctor.
Danish: Du må ikke holde op med at tage dette lægemiddel uden først at have talt med lægen.
English: Delstrigo Once Daily ISG
Danish: Delstrigo En gang dagligt ISG
English: Although the effect of supplementation with calcium and Vitamin D was not studied, such supplementation may be beneficial in all patients.
Danish: Selvom effekten af tilskud med calcium og D-vitamin ikke blev undersøgt, kan sådanne tilskud være gavnlige hos alle patienter.
English: Difference (95 % CI)
Danish: Forskel (95% CI)
English: The most frequently reported adverse reactions considered possibly or probably related to doravirine were nausea (4 %) and headache (3 %).
Danish: De hyppigst rapporterede bivirkninger, som ansås at være muligvis eller sandsynligvis relateret til doravirin, var kvalme (4%) og hovedpine (3%).
English: In humans, the only known metabolite is the trans-sulphoxide metabolite (approximately 5 % of an oral dose after 12 hours).
Danish: Hos mennesker er den eneste kendte metabolit trans-sulfoxid-metabolitten (ca. 5% af en oral dosis efter 12 timer).
English: If you take certain medicines your doctor may need to change the amount of doravirine you take.
Danish: Hvis du tager visse lægemidler, kan lægen blive nødt til at ændre den mængde doravirin, du tager.
English: Use with caution when driving, riding a bicycle, or operating machines if you feel tired, dizzy, or sleepy after taking this medicine
Danish: Vær forsigtig, når du fører motorkøretøj, kører på cykel eller betjener maskiner, hvis du føler dig træt, svimmel eller søvnig, efter at du har taget dette lægemiddel.
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), or very rare (< 1/10,000).
Danish: Hyppighederne defineres 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) eller Meget sjælden (< 1/10.000).
English: NNRTI substitutions and use of doravirine
Danish: NNRTI-substitutioner og brug af doravirin
English: If you stop taking Delstrigo, your doctor will need to check your health often and do blood tests regularly for several months to check your HIV infection.
Danish: Hvis du holder op med at tage Delstrigo, vil det være nødvendigt for lægen at undersøge dit helbred ofte og tage blodprøver regelmæssigt i flere måneder for at kontrollere din hiv-infektion.
English: NNRTI-associated mutations detected at screening were part of exclusion criteria in the Phase 2b/3-studies.
Danish: NNRTI-associerede mutationer detekteret ved screening var del af eksklusionskriterierne i fase 2b/3-studierne.
English: Viral subtype non-B
Danish: Undertype af virus non-B
English: Tell your doctor right away if you start having any new symptoms after starting your HIV medicine.
Danish: Fortæl det straks til lægen, hvis du begynder at få nye symptomer, efter at du er startet med din hiv-medicin.
English: • increasing the number of white blood cells called ‘CD4
Danish: • øge antallet af en slags hvide blodlegemer, der kaldes ‘CD4
English: There is insufficient information on the effects of tenofovir in newborns/infants.
Danish: Der er utilstrækkelig information om tenofovirs virkning hos nyfødte/spædbørn.
English: On study but missing data in window
Danish: I studie men manglende data i tidsvinduet
English: Other reasons include: lost to follow-up, non-compliance with study drug, physician decision, protocol deviation, withdrawal by subject.
Danish: Andre grunde inkluderer: tabt i forhold til follow-up, non-compliance med studiemedicinen, lægelig beslutning, protokolafvigelse, forsøgspersonens udtræden af studiet.
English: Biliary excretion of unchanged medicinal product may contribute to the elimination of doravirine, but this elimination route is not expected to be significant.
Danish: Biliær udskillelse af uomdannet lægemiddel kan bidrage til elimineringen af doravirin, men denne eliminationsvej forventes ikke at være signifikant.
English: AUC0-24 μM hr
Danish: AUC0-24 μM t
English: Delstrigo may have a minor influence on the ability to drive and use machines.
Danish: Delstrigo kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: This can happen when you start taking any HIV medicine, including Delstrigo.
Danish: Dette kan opstå, når du begynder at tage en hvilken som helst hiv-medicin, herunder Delstrigo.
English: Table 1: Interactions between the individual components of Delstrigo and other medicinal products
Danish: Tabel 1: Interaktioner mellem enkeltstofferne i Delstrigo og andre lægemidler
English: *For Week 96, certain subjects with missing HIV-1 RNA were excluded from the analysis.
Danish: *For uge 96 blev visse forsøgspersoner med manglende hiv-1-RNA-data udelukket fra analysen.
English: This can happen in some people who take Delstrigo.
Danish: Dette kan forekomme hos nogle personer, der tager Delstrigo.
English: You can still pass on HIV when taking Delstrigo, although effective therapy lowers the risk.
Danish: Du kan stadig overføre hiv, når du tager Delstrigo, selvom effektiv behandling sænker risikoen.
English: This is because other medicines may affect how Delstrigo works, and Delstrigo might affect the way some other medicines work.
Danish: Årsagen er, at andre lægemidler kan påvirke, hvordan Delstrigo virker, og Delstrigo kan påvirke, hvordan andre lægemidler virker.
English: ISG-DSG, Difference (95 % CI)*
Danish: ISG-DSG, Forskel (95 % CI)*
English: Mineralisation defects
Danish: Mineraliseringsdefekter
English: There are no or limited amount of data from the use of doravirine in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af doravirin til gravide kvinder.
English: Cobicistat-boosted elvitegravir
Danish: Cobicistat-boostet elvitegravir
English: Doravirine has a terminal half-life (t1/2) of approximately 15 hours.
Danish: Doravirin har en terminal halveringstid (t1/2) på ca. 15 timer.
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 lamivudins sikkerhed, når det administreres til børn, som er under tre måneder gamle.
English: There are some medicines you must not take with Delstrigo.
Danish: Der er visse lægemidler, som du ikke må tage sammen med Delstrigo.
English: Week 96*
Danish: Uge 96*
English: Delstrigo is a complete regimen taken as a single tablet for the treatment of HIV infection.
Danish: Delstrigo er et komplet regime, der tages som en enkelt tablet til behandling af hiv-infektion.
English: Rare rectal tenesmus
Danish: Sjælden tenesmi rectales
English: Tenofovir is excreted in human milk.
Danish: Tenofovir udskilles i human mælk.
English: There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2).
Danish: Der er ingen tegn på, at ældre patienter kræver en anden dosis end yngre voksne patienter (se pkt.
English: Pharmacotherapeutic group: Antivirals for systemic use, ATC code: J05AR24
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, ATC-kode: J05AR24
English: The clinical relevance of a 5-10 fold change reduction in susceptibility is unknown.
Danish: Den kliniske relevans af en 5-10 gange reduktion i følsomhed er ukendt.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission of HIV-1, a residual risk cannot be excluded.
Danish: Selvom effektiv virussuppression med antiretroviral behandling har vist sig at nedsætte risikoen for seksuel overførsel af hiv-1 væsentligt, kan en residualrisiko ikke udelukkes.
English: These differences in pharmacokinetics are not clinically relevant.
Danish: Disse forskelle i farmakokinetikken er ikke klinisk relevante.
English: Cross-resistance has been observed among NRTIs.
Danish: Der er observeret krydsresistens mellem NRTIer.
English: Keep desiccant inside the bottle and do not throw away until you have finished taking all of the medicine.
Danish: Lad tørremidlet blive i flasken og lad være med at kassere det, før du er færdig med at tage al medicinen.
English: Baseline Regimen DSG
Danish: Baseline-regime DSG
English: mannitol, lactitol or maltitol), if taken regularly
Danish: xylitol, mannitol, lactitol eller maltitol), hvis de anvendes regelmæssigt.
English: Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) kan også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion.
English: Information regarding potential medicinal product interactions with other antiretroviral medicines is not provided.
Danish: Oplysninger om potentielle lægemiddelinteraktioner med andre antiretrovirale lægemidler er ikke medtaget her.
English: The use of Delstrigo in people aged less than 18 years has not yet been studied.
Danish: Anvendelse af Delstrigo til personer under 18 år er endnu ikke undersøgt.
English: This is because it has not been studied in pregnancy and it is not known if Delstrigo will harm your baby while you are pregnant.
Danish: Dette skyldes, at Delstrigo ikke er undersøgt under graviditet, og det er ukendt, om Delstrigo kan skade dit ufødte barn, mens du er gravid.
English: Endothelin Receptor Antagonists bosentan
Danish: Endothelinreceptorantagonister bosentan
English: The doravirine-based regimens demonstrated consistent efficacy across demographic and baseline prognostic factors.
Danish: Virkningen af doravirin-baserede regimer var konsistent på tværs af demografiske faktorer og prognostiske faktorer ved baseline.
English: Following oral administration, the terminal halflife of tenofovir is approximately 12 to 18 hours.
Danish: Efter oral administration er tenofovirs terminale halveringstid ca. 12 til 18 timer.
English: Delstrigo is a complete regimen for the treatment of HIV-1 infection; therefore, Delstrigo should not be administered with other antiretroviral medicinal products.
Danish: Delstrigo er et komplet regime til behandling af hiv-1-infektion; derfor må Delstrigo ikke administreres sammen med andre antiretrovirale lægemidler.
English: Doravirine has an estimated absolute bioavailability of approximately 64 % for the 100 mg tablet.
Danish: Doravirin har en estimeret absolut biotilgængelighed på ca. 64% for 100 mg tabletten.
English: Psychostimulants modafinil
Danish: Psykostimulantia modafinil
English: If you have HIV infection and hepatitis B infection, it is especially important not to stop your Delstrigo treatment without talking to your doctor first.
Danish: Hvis du har hiv-infektion og hepatitis B-infektion, er det særligt vigtigt ikke at stoppe med din Delstrigobehandling uden først at have talt med lægen.
English: The adverse reactions with suspected (at least possible) relationship to treatment are listed below by body system organ class and frequency.
Danish: Bivirkninger med en formodet (som minimum mulig) sammenhæng med behandlingen er anført nedenfor efter systemorganklasse og hyppighed.
English: Women with HIV should not breastfeed because HIV can be passed on to babies through breast milk.
Danish: Kvinder med hiv frarådes at amme, da hiv-infektionen kan overføres til spædbarnet gennem brystmælken.
English: GM: Geometric mean, %CV: Geometric coefficient of variation
Danish: GM: Geometrisk gennemsnit, %CV: Geometrisk variationskoefficient.
English: New or worsening kidney problems, including kidney failure This can happen in some people who take Delstrigo.
Danish: Nye eller forværrede nyreproblemer, herunder nyresvigt Dette kan forekomme hos nogle personer, der tager Delstrigo.
English: If Delstrigo is stopped your doctor may recommend that you resume hepatitis B treatment.
Danish: Hvis behandlingen med Delstrigo stoppes, kan lægen anbefale, at du genoptager hepatitis B-behandling.
English: Investigations Common alanine aminotransferase increased
Danish: Undersøgelser Almindelig forhøjet alaninaminotransferase
English: If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor about the risks and benefits of taking Delstrigo.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds om risici og fordele ved at tage Delstrigo.
English: There were insufficient numbers from racial and ethnic groups other than Caucasian to adequately determine potential pharmacokinetic differences among these populations following the administration of tenofovir disoproxil.
Danish: Der var ikke et tilstrækkeligt antal fra de racemæssige og etniske grupper, som ikke var kaukasiere, til fyldestgørende at bestemme potentielle farmakokinetiske forskelle mellem disse populationer efter administrationen af tenofovirdisoproxil.
English: You can also report side effects directly via the national reporting system listed in Appendix V.By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • It is important that you do not miss or skip doses of Delstrigo.
Danish: • Det er vigtigt, at du ikke glemmer eller springer doser af Delstrigo over.
English: HIV is the virus that causes AIDS (‘acquired immune deficiency syndrome').
Danish: Hiv er det virus, der forårsager aids (‘erhvervet immundefektsyndrom').
English: It is unknown whether doravirine is excreted in human milk.
Danish: Det er ukendt, om doravirin udskilles i human mælk.
English: Includes subjects who discontinued because of adverse event (AE) or death if this resulted in no virologic data on treatment during the specified window.
Danish: Inkluderer forsøgspersoner, som udtrådte af studiet på grund af bivirkninger (AE) eller død, hvis dette resulterede i ingen virologiske data ved behandling under det specificerede vindue.
English: Week 24 N=223
Danish: Uge 24 N=223
English: Very rare peripheral neuropathy (or paraesthesia)*
Danish: Meget sjælden perifer neuropati (eller paræstesi)*
English: fluconazole itraconazole posaconazole voriconazole
Danish: fluconazol itraconazol posaconazol voriconazol
English: • reducing the amount of HIV in your blood (this is called your ‘viral load')
Danish: • nedsætte mængden af hiv i dit blod (dette kaldes din ‘virusmængde').