FrancophonIA/ELRC3.0 huggingface dataset:
English: Pain in extremity Vomiting Flushing Arthralgia
Danish: Smerter i ekstremiteterne Opkastning
English: What Uptravi looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Uptravi 1,400 microgram film-coated tablets Round, dark-yellow, film-coated tablets with “14” debossed on one side.
Danish: Uptravi 1.400 mikrogram filmovertrukne tabletter Runde, mørkegule, filmovertrukne tabletter, der er præget med "14" på den ene side.
English: Uptravi 1,600 microgram film-coated tablets.
Danish: Uptravi 1.600 mikrogram filmovertrukne tabletter.
English: Uptravi 200 microgram film-coated tablets Round, light-yellow, film-coated tablets with “2” debossed on one side.
Danish: Uptravi 200 mikrogram filmovertrukne tabletter Runde, lysegule, filmovertrukne tabletter, der er præget med "2" på den ene side.
English: Uptravi 800 microgram film-coated tablet
Danish: Uptravi 800 mikrogram filmovertrukket tablet:
English: Uptravi 1,400 microgram film-coated tablets Each film-coated tablet contains 1,400 micrograms of selexipag.
Danish: Uptravi 1.400 mikrogram filmovertrukne tabletter indeholder 1.400 mikrogram selexipag.
English: Uptravi 1,200 microgram film-coated tablets Round, dark-violet, film-coated tablets with “12” debossed on one side.
Danish: Uptravi 1.200 mikrogram filmovertrukne tabletter Runde, mørkelilla, filmovertrukne tabletter, der er præget med "12" på den ene side.
English: Hepatic impairment
Danish: Hypromellose,
English: Uptravi 1,000 microgram film-coated tablet
Danish: Uptravi 1.000 mikrogram filmovertrukket tablet:
English: Uptravi 400 microgram film-coated tablet
Danish: Uptravi 400 mikrogram filmovertrukket tablet:
English: Uptravi 1,600 microgram film-coated tablets Each film-coated tablet contains 1,600 micrograms of selexipag.
Danish: Uptravi 1.600 mikrogram filmovertrukne tabletter indeholder 1.600 mikrogram selexipag.
English: Uptravi 1,200 microgram film-coated tablet
Danish: Uptravi 1.200 mikrogram filmovertrukket tablet:
English: Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide red (E172), carnauba wax.
Danish: Hypromellose, propylenglycol, titandioxid (E171), jernoxid, rød (E172), carnaubavoks.
English: There is limited clinical experience with selexipag in patients over the age of 75 years, therefore Uptravi should be used with caution in this population (see section 4.2).
Danish: Der er begrænset klinisk erfaring med brug af selexipag hos patienter over 75 år.
English: Uptravi 1,400 microgram film-coated tablet
Danish: Uptravi 1.400 mikrogram filmovertrukket tablet:
English: Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide yellow (E172), carnauba wax.
Danish: Hypromellose, propylenglycol, titandioxid (E171), jernoxid, gul (E172), carnaubavoks.
English: Uptravi 600 microgram film-coated tablet
Danish: Uptravi 600 mikrogram filmovertrukket tablet:
English: doctor or nurse regularly during titration.
Danish: Husk, at du skal være i regelmæssig kontakt med din PAH-læge eller sundhedspersonalet i titreringsforløbet.
English: Uptravi 1,600 microgram film-coated tablet
Danish: Uptravi 1.600 mikrogram filmovertrukket tablet:
English: Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide black (E172), iron oxide red (E172), carnauba wax.
Danish: Hypromellose, propylenglycol, titandioxid (E171), jernoxid, sort (E172), jernoxid, rød (E172), carnaubavoks.
English: What Uptravi is and what it is used for What you need to know before you take Uptravi How to take Uptravi
Danish: Det skal du vide, før du begynder at tage Uptravi Sådan skal du tage Uptravi Bivirkninger
English: Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), carnauba wax.
Danish: Hypromellose, propylenglycol, titandioxid (E171), jernoxid, rød (E172), jernoxid, gul (E172), carnaubavoks.
English: How to take Uptravi
Danish: Sådan skal du tage Uptravi
English: Tablet core
Danish: Hæmoglobin nedsat
English: Hypromellose, propylene glycol, titanium dioxide (E171), iron oxide yellow (E172), iron oxide black (E172), carnauba wax.
Danish: Hypromellose, propylenglycol, titandioxid (E171), jernoxid, gul (E172), jernoxid , sort (E 172), carnaubavoks.
English: What it is used for?
Danish: Hvad anvendes det til?
English: Date of opening:___________
Danish: Dato for åbning:___________
English: This is not a complete list of medicines.
Danish: Dette er ikke en komplet liste over lægemidler.
English: The same recommendations apply, unless specifically indicated.
Danish: Der gælder de samme anbefalinger, medmindre andet specifikt er angivet.
English: In some patients additional factor VIII was given.
Danish: Hos nogle patienter blev der givet supplerende faktor VIII.
English: Use with caution.
Danish: Brug med forsigtighed.
English: The type of food is not important.
Danish: Typen af mad er ikke vigtig.
English: Date of first authorisation: 26 January 2018
Danish: Dato for første markedsføringstilladelse: 26. januar 2018
English: 8501 Novo mesto Slovenia
Danish: 8501 Novo mesto SLOVENIEN
English: Your doctor will explain these to you.
Danish: Lægen vil forklare dette for dig.
English: This can be seen in a blood test.
Danish: Dette kan ses ved en blodprøve.
English: Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Danish: Sådanne reaktioner er typisk observeret inden for de første uger eller måneder efter påbegyndelse af CART.
English: This difference is not clinically relevant.
Danish: Forskellen er ikke klinisk relevant.
English: You must keep in regular contact with your doctor.
Danish: Du skal være i løbende kontakt med din læge.
English: ARTEMIS Week 192
Danish: ARTEMIS Uge 192
English: Virologic response was preserved throughout the study period in both arms.
Danish: Virologisk respons blev bibeholdt i hele studieperioden i begge arme.
English: In an interaction study
Danish: I et interaktionsstudie
English: In some cases dosage of other medicines might need to be changed.
Danish: I nogle tilfælde kan der være behov for at ændre doseringen af andre lægemidler.
English: Overall, the safety profile in these paediatric patients was similar to that observed in the adult population.
Danish: Sikkerhedsprofilen hos disse pædiatriske patienter var generelt sammenlignelig med den, der er observeret hos den voksne population.
English: Regular assessment of virological response is advised.
Danish: Regelmæssig kontrol af virologisk respons anbefales.
English: Number of baseline mutations
Danish: Antal af baseline mutationer
English: In more than half of the reported cases, treatment with PIs was continued or reintroduced if treatment had been discontinued.
Danish: I mere end halvdelen af de rapporterede tilfælde fortsatte behandlingen med PI eller blev genoptaget, hvis den havde været afbrudt.
English: Tell your doctor about your situation BEFORE and DURING your treatment Make sure that you check the following points and tell your doctor if any of these apply to you.
Danish: Fortæl din læge om dit helbred FØR og UNDER din behandling Sørg for at tjekke følgende punkter og fortæl din læge, hvis nogen af dem gælder for dig.
English: However, only limited data were available in patients above the age of 65 year.
Danish: Der foreligger dog kun begrænsede data om patienter over 65 år.
English: It is not possible to administer all paediatric dosages with this product.
Danish: Det er ikke muligt at administrere alle pædiatriske doser med dette produkt.
English: Darunavir was rapidly absorbed following oral administration.
Danish: Darunavir blev hurtigt optaget efter oral administration.
English: Liver problems that may occasionally be severe have been reported.
Danish: Der er rapporteret om leverproblemer, der somme tider kan være alvorlige.
English: A causal relationship has been suggested, although the mechanism of action has not been elucidated.
Danish: En kausal sammenhæng har været foreslået, selvom virkningsmekanismen ikke er blevet belyst.
English: The mean treatment duration was 58.4 weeks.
Danish: Behandlingens middelvarighed var 58,4 uger.
English: Tell your doctor immediately if you are pregnant, planning to become pregnant or if you are breastfeeding.
Danish: Fortæl straks din læge, hvis du er gravid, planlægger at blive gravid eller ammer.
English: Consideration should be given to official guidance on the appropriate treatment of tuberculosis in HIV infected patients.
Danish: Der skal tages højde for de officielle retningslinjer for korrekt behandling af tuberkulose hos hiv-inficerede patienter.
English: In vitro selection of darunavir-resistant virus from wild type HIV-1 was lengthy (> 3 years).
Danish: In vitro-selektion af darunavirresistent virus fra vildtype hiv-1 tog lang tid (> 3 år).
English: Very common side effects (may affect more than 1 in 10 people) diarrhoea.
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) - diarré.
English: Never suppressed subjects
Danish: Individer, der aldrig har været supprimerede
English: The unbound fraction was also substantially reduced, including around 90% reductions of Cmin levels.
Danish: Den ubundne fraktion var også væsentligt reduceret, herunder reduktioner i værdierne for Cmin på ca. 90 %.
English: Some additional tests might be necessary.
Danish: Det kan være nødvendigt at foretage yderligere test.
English: Treatment difference (95% CI of difference)
Danish: Behandlingsforskel (95 % CI for forskel)
English: Renal impairment Results from a mass balance study with
Danish: Nedsat nyrefunktion Resultater af et massebalancestudie med
English: Due to a decrease in the exposure (AUC) of darunavir by 40%, appropriate doses of the combination have not been established.
Danish: På grund af et fald i eksponering (AUC) af darunavir med 40 % er de rette doser af kombinationen ikke blevet fastlagt.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling af hepatitis B eller C henvises der til den relevante produktinformation for disse lægemidler.
English: Examples are: increase in some white blood cells.
Danish: Eksempel: stigning i antallet af visse hvide blodlegemer.
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Det menes, at disse symptomer skyldes en forbedring af kroppens immunforsvar, der gør det muligt for kroppen at bekæmpe infektioner, der kan have været til stede uden nogen tydelige symptomer.
English: Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor's instruction carefully on which medicines can be combined.
Danish: Du skal derfor altid fortælle din læge, hvis du tager anden hiv-medicin og følge din læges anvisninger nøje med hensyn til hvilken medicin, der kan tages sammen.
English: On rare occasions, these muscle disorders have been serious.
Danish: Disse muskellidelser har i sjældne tilfælde været alvorlige.
English: This strength is not suitable for dosages below 600 mg.
Danish: Denne styrke er ikke egnet til doser under 600 mg.
English: to treat gout or familial Mediterranean fever
Danish: til behandling af urinsur gigt eller familiær middelhavsfeber
English: This product is only available as film coated tablets and is thus not suitable for patients who are unable to swallow intact tablets, for example young children.
Danish: Dette produkt findes kun som tabletter og er derfor ikke egnet til patienter, som ikke kan synke hele tabletter f.eks. mindre børn.
English: an up to five-fold increase was seen in a limited subset of subjects
Danish: en op til femdobling blev set hos en begrænset undergruppe af forsøgspersoner
English: Greater effects may be expected when fluticasone is inhaled.
Danish: Der kan forventes en større effekt, når fluticason inhaleres.
English: Frequency categories are defined as follows: 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) and not known (frequency cannot be estimated from the available data).
Danish: Hyppighedskategorierne 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: A skin rash might also be a symptom of a rare severe situation.
Danish: Et hududslæt kan også være et symptom på en sjælden, men alvorlig situation.
English: The doctor will determine if once daily dosing or twice daily dosing is appropriate for the child.
Danish: Lægen vil afgøre, om en dosis en gang dagligt eller to gange dagligt er passende for barnet.
English: These effects may be secondary to pup exposure to the active substance via the milk and/or maternal toxicity.
Danish: Disse virkninger kan være sekundære til ungernes eksponering for det aktive stof via mælken og/eller maternel toksicitet.
English: These EC50 values are well below the 50% cellular toxicity concentration range of 87 µM to > 100 µM.
Danish: Disse EC50-værdier ligger et godt stykke under 50 % af koncentrationsområdet for cellulær toksicitet på 87 µM til > 100 µM.
English: POWER 1 and POWER 2 pooled data Week 48
Danish: Samlede data fra POWER 1 og POWER 2 Uge 48
English: If you notice any of these symptoms please inform your doctor.
Danish: Hvis du bemærker nogen af disse symptomer, bedes du kontakte din læge.
English: Efficacy analysis is based on 48 weeks of treatment (see table below).
Danish: Effektanalysen er baseret på 48 ugers behandling (se tabellen nedenfor).
English: Tell your doctor if you have had problems with your liver before, including hepatitis B or C infection.
Danish: - Fortæl din læge, hvis du tidligere har haft problemer med leveren, herunder hepatitis B- eller C-infektion.
English: The clinical relevance of the increase in norbuprenorphine pharmacokinetic parameters has not been established.
Danish: Den kliniske relevans af stigningen i norbuprenorphins farmakokinetiske parametre er ikke fastlagt.
English: When co-administration is required the daily dose of itraconazole should not exceed 200 mg.
Danish: Ved behov for co-administration bør den daglige dosis af itraconazol ikke overskride 200 mg.
English: Therefore, clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients.
Danish: Derfor anbefales klinisk monitorering, da justering af vedligeholdelsesbehandling kan være nødvendig hos nogle patienter.
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 Appendix V. Ved at indrapportere bivirkninger kan du bidrage til at tilvejebringe mere information om sikkerheden af dette lægemiddel.
English: In the table below the specific pharmacokinetic enhancer is specified when recommendations differ.
Danish: I nedenstående tabel er den specifikke farmakokinetiske forstærker angivet, når anbefalingerne er forskellige.
English: Your doctor might want to do some additional tests.
Danish: Din læge vil muligvis foretage yderligere tests.
English: MedDRA system organ class Frequency category
Danish: MedDRA systemorganklasse Hyppighed
English: Analyses of data through 96 weeks of treatment in the POWER trials demonstrated sustained antiretroviral efficacy and immunologic benefit.
Danish: Dataanalyser gennem 96 ugers behandling i POWER-studierne påviste vedvarende antiretroviral effekt og immunologisk fordel.
English: Colchicine (if you have kidney and/or liver problems)
Danish: Colchicin (hvis du har problemer med nyrerne og/eller leveren)
English: Data based on analyses at week 96
Danish: Data baseret på analyser ved uge 96
English: In the dog, no major toxicity findings or target organs were identified up to exposures equivalent to clinical exposure at the recommended dose.
Danish: Hos hunde blev der ikke identificeret nogen større toksicitetsfund eller målorganer op til eksponeringer svarende til klinisk eksponering ved den anbefalede dosis.
English: Adverse reactions are listed by system organ class (SOC) and frequency category.
Danish: Bivirkningerne er opstillet efter systemorganklasse (SOC) og hyppighedskategori.
English: Cobicistat levels decrease and may not provide sufficient boosting.
Danish: Værdierne for cobicistat falder og giver muligvis ikke tilstrækkelig boostning.
English: Patients with coexisting conditions
Danish: Patienter med co-eksisterende tilstande
English: Tell your doctor if you develop any of the following side effects.
Danish: Fortæl din læge, hvis du får nogen af de følgende bivirkninger.
English: ART-experienced patients - once daily dosing
Danish: ART-erfarne patienter - dosering en gang daglig
English: Ask your doctor if you are unsure about the severity of your liver disease.
Danish: Du skal spørge din læge, hvis du ikke er sikker på, hvor alvorlig din leversygdom er.
English: Ethinylestradiol/drospirenone.
Danish: - ethinylestradiol/drospirenon.
English: The main cause of these low exposures is a marked reduction in cobicistat exposure as a consequence of pregnancy-associated enzyme induction (see below).
Danish: Hovedårsagen til disse lave eksponeringer er en markant reduktion i eksponering for cobicistat som følge af graviditetsassocieret enzyminduktion (se nedenfor).
English: Daily doses of 150, 450 and 1,000 mg/kg were administered to mice and doses of 50, 150 and 500 mg/kg were administered to rats.
Danish: Daglige doser på 150, 450 og 1.000 mg/kg blev administreret til mus, og doser på 50, 150 og 500 mg/kg blev administreret til rotter.
English: Exposure in plasma, liver and brain was considerably higher than in adult rats after comparable doses in mg/kg between days 5 and 11 of age.
Danish: Eksponeringen i plasma, lever og hjerne var betydeligt højere end hos voksne rotter efter sammenlignelige doser i mg/kg ved en alder på mellem 5 og 11 dage.
English: Control n=124
Danish: Kontrol n=124
English: Rifampicin to treat some infections such as tuberculosis
Danish: Rifampicin til behandling af visse infektioner såsom tuberkulose
English: Out of the 59 patients who responded with complete viral suppression (< 50 copies/ml) at week 48, 47 patients (80% of the responders at week 48) remained responders at week 96.
Danish: Af de 59 patienter, der responderede med komplet virologisk suppression (< 50 kopier/ml) ved uge 48, var 47 patienter (80 % af de responderende i uge 48) fortsat responderende i uge 96.
English: It is not known whether darunavir is excreted in human milk.
Danish: Det vides ikke, om darunavir udskilles i human mælk.
English: The total mean treatment duration for subjects was 95.3 weeks.
Danish: Den samlede gennemsnitlige behandlingsvarighed for deltagerne var 95,3 uger.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR -MENNESKELIGT LÆSBARE DATA
English: The clinical relevance of this increase is unknown therefore, darunavir should be used with caution.
Danish: Den kliniske relevans af denne stigning kendes ikke, og darunavir bør derfor anvendes med forsigtighed.
English: Tell your doctor immediately if you notice any symptoms of infection (for example enlarged lymph nodes and fever).
Danish: - Fortæl straks din læge, hvis du bemærker nogen symptomer på infektion (f.eks. forstørrede lymfeknuder og feber).
English: The most frequent adverse reactions reported were diarrhoea (28%), nausea (23%), and rash (16%).
Danish: De hyppigst rapporterede bivirkninger var diarre (28 %), kvalme (23 %) og udslæt (16 %).
English: Tell your healthcare provider about all medicines that you are taking.
Danish: Fortæl din læge om al medicin, du tager.
English: Carbamazepine concentrations should be monitored and its dose should be titrated for adequate response.
Danish: Carbamazepinkoncentrationer skal monitoreres og der dosistitreres til et passende respons.
English: darunavir AUC24h ↑ 33% (based on population pharmacokinetic model)
Danish: darunavir AUC24h ↑ 33 % (baseret på en populationsfarmakokinetisk model)
English: Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Danish: Tag altid lægemidlet nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens, apotekspersonalets eller sygeplejerskens anvisning.
English: Primary (major) PI mutations
Danish: Primære (major) PImutationer
English: What is Darunavir Krka?
Danish: Hvad er Darunavir Krka?
English: Clarithromycin (antibiotic)
Danish: - Clarithromycin (antibiotikum).
English: In a study conducted in rats, the number of corpora lutea and implantations were decreased in the presence of maternal toxicity.
Danish: I studiet med rotter faldt antallet af corpora lutea og implantationssteder ved tilstedeværelse af maternel toksicitet.
English: Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedskategori er bivirkningerne anført efter aftagende alvorlighed.
English: The exposure levels were lower than those with the recommended clinical dose in humans.
Danish: Eksponeringsniveauerne var lavere end ved den anbefalede kliniske dosis til mennesker.
English: Keep the bottle tightly closed in order to protect from moisture.
Danish: Hold beholderen tæt lukket for at beskytte mod fugt.
English: These interactions are described in the interaction table below.
Danish: Disse interaktioner er beskrevet i interaktionstabellen neden for.
English: These can be seen in the results of blood and/or urine tests.
Danish: De fremgår af blod- eller urinprøver.
English: * Using cross-study comparisons to historical pharmacokinetic data
Danish: * Ved brug af historiske farmakokinetiske data på tværs af studier
English: If you belong to this age group, please discuss with your doctor if you can use Darunavir Krka.
Danish: Hvis du tilhører denne aldersgruppe, skal du spørge din læge, om du kan anvende Darunavir Krka.
English: Investigations common increased blood creatinine
Danish: Undersøgelser almindelig forhøjet kreatinin i blodet
English: If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Danish: Hvis andre lægemidler ikke kan anvendes, bør anvendelse kun ske efter en lægelig vurdering og kun, hvis lægen nøje overvåger dig for bivirkninger af kortikosteroiderne.
English: Infrequently a rash may become severe or potentially life-threatening.
Danish: I sjældne tilfælde kan hududslættet blive alvorligt eller måske livstruende.
English: According to the TLOVR non-virologic failure censored algorithm 24 (30.0%) patients experienced virological failure, of which 17 (21.3%) patients were rebounders and 7 (8.8%) patients were nonresponders.
Danish: Ifølge den TLOVR non-virologisk svigt censorerede algoritme oplevede 24 (30,0 %) patienter virologisk svigt, af hvilke 17 (21,3 %) patienter fik tilbagefald og 7 (8,8 %) patienter ikke responderede på behandlingen.
English: Dose-related increases in the incidences of hepatocellular adenomas and carcinomas were observed in males and females of both species.
Danish: Dosisrelaterede stigninger i incidensen af hepatocellulære adenomer og karcinomer blev observeret hos både hanner og hunner af begge arter.
English: However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (ChildPugh Class B) higher, respectively.
Danish: Dog var koncentrationer af ubundet darunavir henholdsvis ca. 55% (Child- Pugh klasse A) og 100% (Child-Pugh klasse B) højere.
English: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS Medicinal products by therapeutic areas
Danish: INTERAKTIONER OG DOSISANBEFALINGER MED ANDRE LÆGEMIDLER Lægemidler efter terapeutisk område
English: This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Danish: Dette forbedrer immunforsvaret og nedsætter risikoen for at udvikle sygdomme, der er forbundet med hiv-infektion.