FrancophonIA/ELRC3.0 huggingface dataset:
English: • If differentiation syndrome is suspected, corticosteroid therapy should be initiated along with hemodynamic monitoring until symptom resolution.
Danish: • Hvis der er mistanke om differentieringssyndrom, skal kortikosteroid-behandling initieres sammen med hæmodynamisk monitorering, indtil symptomerne er ophørt.
English: Grades
Danish: Grader
English: Males of reproductive potential should be advised to use effective contraception during treatment and for at least 4 months after the last dose of Xospata (see section 4.4).
Danish: Mænd i den fertile alder skal rådes til at bruge sikker prævention under behandlingen og i mindst 4 måneder efter den sidste dosis Xospata (se pkt.
English: • Resume gilteritinib at a reduced dose (80 mg or 120 mgb) when QTc interval returns to within 30 msec of baseline or ≤ 480 msec.
Danish: 120 mg b), når QTc-intervallet er tilbage til 30 ms indenfor baseline eller ≤480 ms.
English: 14.7 0.6 Very common
Danish: 14,7 0,6 Meget almindelig
English: - Description of signs or symptoms of the safety concern and when to seek medical care if differentiation syndrome is suspected - A warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Xospata.
Danish: - En advarsel til sundhedsprofessionelle, der på noget tidspunkt behandler patienten, herunder i nødsituationer, om at patienten bruger Xospata.
English: България Астелас Фарма ЕООД
Danish: Астелас Фарма ЕООД Teл.
English: Women of childbearing potential / Contraception in males and females Pregnancy testing is recommended for females of reproductive potential seven days prior to initiating Xospata treatment.
Danish: Graviditetstest anbefales hos kvinder i den fertile alder, syv dage inden behandling med Xospata initieres.
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet Træthed
English: - collection of fluid around the heart, which, if severe, can decrease the heart's ability to pump blood (pericardial effusion) - a vague feeling of discomfort, feeling unwell (malaise) - a severe life-threatening allergic reaction, e.g., swelling in the mouth, tongue, face and throat, itching, hives (anaphylactic reaction) - muscle stiffness - passing less urine, swelling in the legs (signs of sudden kidney injury)
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): - væskeophobning omkring hjertet, som, i alvorlige tilfælde, kan nedsætte hjertets evne til at pumpe blodet (perikardieeffusion) - en vag følelse af ubehag, følelse af ikke at have det godt (utilpashed) - en svær, livstruende allergisk reaktion, f.eks. hævelse i munden, tungen, ansigtet og halsen,
English: Due to in vitro binding to 5HT2B (see section 4.5), there is a potential impact on cardiac development in patients less than 6 months of age.
Danish: 4.5), er der en potentiel påvirkning af udviklingen af hjertet hos patienter, der er yngre end 6 måneder.
English: 35.1 4.1 Very common
Danish: 35,1 4,1 Meget almindelig
English: In healthy subjects, co-administration of rifampicin (600 mg), a strong CYP3A/P-gp inducer, to steady state with a single 20 mg dose of gilteritinib decreased gilteritinib mean Cmax by 27% and mean AUCinf by 70%, respectively, compared to subjects administered a single dose of gilteritinib alone (see section 4.4).
Danish: Hos raske forsøgspersoner nedsatte samtidig administration af rifampicin (600 mg), en stærk CYP3A/P-gpinduktor, og en enkelt dosis gilteritinib på 20 mg ved steady-state henholdsvis gennemsnitlig Cmax for gilteritinib med 27 % og gennemsnitlig AUCinf med 70 %, sammenlignet med forsøgspersoner, der alene fik en enkelt dosis gilteritinib (se pkt.
English: • Symptoms include fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Danish: • Symptomerne omfatter feber, dyspnø, pleural effusion, perikardieeffusion, pulmonært ødem, hypotension, hurtig vægtøgning, perifert ødem, udslæt og nyreinsufficiens.
English: Do not break or crush the tablets.
Danish: Tabletterne må ikke deles eller knuses.
English: 24.1 4.4 Very common
Danish: 24,1 4,4 Meget almindelig
English: Women taking Xospata who are able to become pregnant should use an effective method of contraception during treatment with Xospata and for at least 6 months after stopping Xospata.
Danish: Kvinder, der tager Xospata, og som kan blive gravide, skal bruge en sikker præventionsmetode under behandling med Xospata, og i mindst 6 måneder efter behandlingen med Xospata er afsluttet.
English: 28.2 0.6 Very common
Danish: 28,2 0,6 Meget almindelig
English: Xospata 40 mg film-coated tablets
Danish: Xospata 40 mg filmovertrukne tabletter.
English: For recommendations in case of suspected differentiation syndrome see sections 4.2 and 4.4.
Danish: Anbefalinger i tilfælde af mistanke om differentieringssyndrom fremgår af pkt.
English: - inflammation of the heart (pericarditis) - heart failure
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer): - betændelsestilstand i hjertet (pericarditis) - nedsat hjertefunktion
English: How to take Xospata
Danish: Sådan skal du tage Xospata
English: Anaphylactic reaction
Danish: Immunsystemet Anafylaktisk reaktion
English: Of the 317 patients treated with gilteritinib at 120 mg with a post-baseline QTC value in clinical studies, 4 patients (1%) experienced a QTcF >500 msec. Additionally, across all doses, 12 patients (2.3%) with relapsed/refractory AML had a maximum post-baseline QTcF interval >500 msec (see sections 4.2, 4.4 and 5.1).
Danish: Af de 317 patienter, der blev behandlet med 120 mg gilteritinib, med en QTC-værdi efter baseline i kliniske studier, havde 4 patienter (1 %) en QTcF >500 ms.
English: Gilteritinib was excreted into the milk of lactating rats with milk concentrations being higher than in maternal plasma.
Danish: Koncentrationen i mælken var højere end den i maternal plasma.
English: 20.4 0.3 Very common
Danish: 20,4 0,3 Meget almindelig
English: - Do not break or crush the tablets.
Danish: - Tabletterne må ikke deles eller knuses.
English: Symptoms and clinical findings of differentiation syndrome in patients treated with Xospata included fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Danish: Symptomer på og kliniske fund af differentieringssyndrom hos de patienter, der blev behandlet med Xospata, omfatter feber, dyspnø, pleural effusion, perikardieeffusion, pulmonært ødem, hypotension, hurtig vægtøgning, perifert ødem, udslæt og nyreinsufficiens.
English: Other medicines and Xospata
Danish: Brug af anden medicin sammen med Xospata
English: 30.4 3.1 Very common
Danish: 30,4 3,1 Meget almindelig
English: 28.2 0.3 Very common
Danish: 28,2 0,3 Meget almindelig
English: - diarrhoea - nausea - constipation - tiredness - swelling due to fluid retention (oedema) - loss of energy, weakness (asthenia) - abnormal blood test results: high levels of blood creatine phosphokinase (indicative of muscle or heart function), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or blood alkaline phosphatase (indicative of liver function) - pain in limbs - joint pain (arthralgia) - muscle pain (myalgia) - cough - shortness of breath (dyspnoea) - dizziness - low blood pressure (hypotension)
Danish: Meget almindelig (kan forekomme hos mere end 1 ud af 10 personer): - diarré - kvalme - forstoppelse - træthed - hævelse på grund af væskeophobning (ødem) - manglende energi, svaghed (asteni) - unormale resultater af blodprøver: højt indhold af kreatinphosphokinase i blodet (fortæller noget om muskel- og hjertefunktionen), alaninaminotransferase (ALAT), aspartataminotransferase
English: 12.5 1.3 Very common
Danish: 12,5 1,3 Meget almindelig
English: Symptoms and clinical findings of differentiation syndrome include fever, dyspnoea, pleural effusion, pericardial effusion, pulmonary oedema, hypotension, rapid weight gain, peripheral oedema, rash, and renal dysfunction.
Danish: Symptomer på og kliniske fund af differentieringssyndrom omfatter feber, dyspnø, pleural effusion, perikardieeffusion, pulmonært ødem, hypotension, hurtig vægtøgning, perifert ødem, udslæt og nyreinsufficiens.
English: • If differentiation syndrome is suspected, administer corticosteroids and initiate hemodynamic monitoring (see section 4.4).
Danish: Symptomer på differentieringssyndrom • Ved mistanke om differentieringssyndrom administreres kortikosteroider, og hæmodynamisk monitorering påbegyndes (se pkt.
English: 12.5 0.3 Very common
Danish: 12,5 0,3 Meget almindelig
English: Table 2: Adverse reactions Adverse drug reaction
Danish: Tabel 2: Bivirkninger
English: The population estimate of central and peripheral volume of distribution were 1092 L and 1100 L, respectively.
Danish: Populationsestimatet af det centrale og perifere fordelingsvolumen var henholdsvis 1092 l og 1100 l. Disse data indikerer, at gilteritinib i vidt omfang fordeles uden for plasma, hvilket kan tyde på en udbredt fordeling i væv.
English: Corticosteroids can be tapered after resolution of symptoms and should be administered for a minimum of 3 days.
Danish: Kortikosteroiderne kan aftrappes, efter at symptomerne er ophørt.
English: How Xospata works
Danish: Sådan virker Xospata
English: • azacitidine 75 mg/m2 once daily by SC or IV for 7 days (days 1 through 7)
Danish: en gang dagligt i 7 dage (dag 1 til og med dag 7)
English: CRa (95% CIb) CRhc (95% CIb) CR/CRh (95% CIb) CI: confidence interval a. CR was defined as an absolute neutrophil count ≥1.0 x 109/L, platelets ≥100 x 109/L, normal marrow differential with <5% blasts, must have been red blood cells, platelet transfusion independent and no evidence of extramedullary leukemia.
Danish: 9/l, normalt marvdifferentiale med <5 % blaster, skal have været røde blodlegemer, uafhængig af trombocyttransfusion og ingen evidens for ekstramedullær leukæmi.
English: 80 mg or 120 mgb.
Danish: Den daglige dosis kan reduceres fra 120 mg til 80 mg eller fra 200 mg til 120 mg.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Denne tilstand kaldes PRES (kan forekomme hos op til 1 ud af 100 personer).
English: • Trouble Breathing
Danish: • Vejrtrækningsbesvær
English: • granulocyte colony-stimulating factor 300 mcg/m2 once daily by SC for 5 days (days 1 to 5), fludarabine 30 mg/m2 once daily by IV for 5 days (days 2 through 6), cytarabine 2000 mg/m2 once daily by IV for 5 days (days 2 through 6), idarubicin 10 mg/m2 once daily by IV for 3 days (days 2 through 4) (FLAG-Ida).
Danish: en gang dagligt i 5 dage (dag 1 til og med dag 5) (MEC) • 300 mikrog/m granulocytkolonistimulerende faktor s.c. en gang dagligt i 5 dage (dag 1 til 5),
English: Musculoskeletal pain
Danish: Mave-tarm-kanalen Diarré
English: Hepatobiliary disorders
Danish: Vaskulære sygdomme Hypotension
English: - if you have a seizure or quickly worsening symptoms such as headache, decreased alertness, confusion, blurred vision or other problems with seeing.
Danish: Det er vigtigt, at du har informationskortet på dig, og at du viser det til alle sundhedspersoner, du kommer i kontakt med. - hvis du får et krampeanfald eller symptomer, der hurtigt forværres, såsom hovedpine, nedsat opmærksomhed, forvirring, sløret syn eller andre problemer med synet.
English: Astellas Pharma Ltd. Tel: +44 (0) 203 379 8700
Danish: Tel: +44 (0) 203 379 8700
English: b. The daily dose can be reduced from 120 mg to 80 mg or from 200 mg to 120 mg. c. Composite complete remission (CRc) is defined as the remission rate of all CR (see section 5.1 for definition of CR), CRp [achieved CR except for incomplete platelet recovery (<100 x 109/L)] and CRi (achieved all criteria for CR except for incomplete haematological recovery with residual neutropenia <1 x 109/L with or without complete platelet recovery).
Danish: 9/l)] og CRi (opnået alle kriterier for CR undtagen for ufuldstændig hæmatologisk bedring med tilbageværende neutropeni <1 × 10
English: Overall survival
Danish: Opbevaring
English: Acute kidney injury
Danish: Nyrer og urinveje Akut nyreskade
English: Method of administration
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: What Xospata is and what it is used for What you need to know before you take Xospata How to take Xospata
Danish: Det skal du vide, før du begynder at tage Xospata Sådan skal du tage Xospata Bivirkninger
English: Contact your doctor straight away if you have any of the following symptoms: fever, trouble breathing, rash, dizziness or lightheadedness, rapid weight gain, swelling of your arms or legs.
Danish: feber, vejrtrækningsbesvær, udslæt, svimmelhed eller ørhed, hurtig vægtstigning, hævelser af arme eller ben.
English: Date of first authorisation: 26 April 2018
Danish: Dato for første markedsføringstilladelse: 26 april 2018
English: Immediate hypersensitivity reactions have been reported after administration of Trydonis.
Danish: Der er rapporteret om øjeblikkelige overfølsomhedsreaktioner efter administration af Trydonis.
English: It is important to use Trydonis every day.
Danish: Det er vigtigt, at du bruger Trydonis hver dag.
English: Trydonis is a medicine to help breathing that contains the three active substances:
Danish: Trydonis er et lægemiddel, der hjælper dig med at trække vejret, og indeholder de tre aktive stoffer:
English: Do not stop using Trydonis or lower the dose, even if you are feeling better or you have no symptoms.
Danish: Du må ikke holde op med at bruge Trydonis eller bruge en lavere dosis, selvom du har det bedre, eller du ikke har nogen symptomer.
English: However, available safety data from longterm clinical studies have not raised any significant safety concerns (see section 5.1).
Danish: Tilgængelige sikkerhedsdata fra langvarige kliniske studier har imidlertid ikke vist nogen signifikant sikkerhedsproblematik (se pkt.
English: Using Trydonis together with:
Danish: Brug af Trydonis sammen med:
English: In addition, two Phase IIIb studies were conducted to support the clinical efficacy and safety of Trydonis.
Danish: Desuden blev der udført to fase IIIb-studier for at støtte Trydonis' kliniske virkning og sikkerhed.
English: The aerosol particles of Trydonis are on average much smaller than the particles delivered in non-extrafine formulations.
Danish: Trydonis' aerosolpartikler er gennemsnitligt meget mindre end de partikler, der leveres i formuleringer, som ikke er ekstrafine.
English: Trydonis does not contain a high-dose inhaled corticosteroid, but your doctor may wish to measure the cortisol levels in your blood from time to time.
Danish: Trydonis indeholder ikke et højdosis, inhaleret kortikosteroid, men lægen kan ønske at måle kortisolniveauet i dit blod fra tid til anden.
English: If any of the above applies to you, tell your doctor before you use Trydonis.
Danish: Hvis noget af det ovenstående gælder for dig, skal du fortælle det til lægen, før du bruger Trydonis.
English: Some medicines may increase the effects of Trydonis and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Danish: Nogle lægemidler kan øge virkningen af Trydonis, og din læge vil overvåge dig omhyggeligt, hvis du tager sådanne lægemidler (inklusive visse former for hiv-medicin, herunder ritonavir og cobicistat).
English: Infants and neonates born to mothers receiving substantial doses of Trydonis should be observed for adrenal suppression.
Danish: Spædbørn og neonatale født af mødre, der fik betragtelige doser af Trydonis, bør observeres for adrenal suppression.
English: You should only use Trydonis during pregnancy if you are advised to do so by your doctor.
Danish: Du må kun anvende Trydonis under graviditet, hvis lægen har rådet dig til det.
English: If you are using Trydonis or high doses of other inhaled corticosteroids over long periods and you come into a situation of stress (e.g. being taken to hospital after an accident, having a serious injury or before an operation) you may need more of this medicine.
Danish: Hvis du bruger Trydonis eller højere doser af andre inhalerede kortikosteroider i lange perioder, og du kommer i en situation med stress (f.eks. hvis du bringes på hospitalet efter et uheld, hvis du har en alvorlig skade eller før en operation), kan du have behov for mere af dette lægemiddel.
English: The clinical development programme of Trydonis was conducted in patients with moderate, severe or very severe COPD.
Danish: Det kliniske udviklingsprogram for Trydonis blev udført hos patienter med moderat, svær eller meget svær KOL.
English: Carcinogenicity studies have not been performed with Trydonis.
Danish: Der er ikke udført karcinogenicitetsstudier med Trydonis.
English: Trydonis is available in three container sizes:
Danish: Trydonis fås i tre beholderstørrelser:
English: Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females), either congenital or induced by medicinal products as these patients were excluded from clinical trials with Trydonis.
Danish: Der bør også udvises forsigtighed ved behandling af patienter med kendt eller formodet forlængelse af QTc-intervallet (QTc > 450 millisekunder for mænd eller > 470 millisekunder for kvinder), enten medfødt eller induceret af lægemidler, da disse patienter blev ekskluderet fra kliniske studier med Trydonis.
English: There is a risk of worsening shortness of breath and wheezing immediately after using Trydonis and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people).
Danish: Der er en risiko for forværret stakåndethed og en hvæsende vejrtrækning umiddelbart efter brug af Trydonis, og dette kaldes paradoks bronkospasme (kan forekomme hos op til 1 ud af 1.000 personer).
English: No specific studies have been performed with Trydonis with regard to the safety in human fertility.
Danish: Der er ikke udført specifikke studier med Trydonis hvad angår sikkerheden på fertiliteten hos mennesker.
English: Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Trydonis and to contact their doctor immediately should any of these signs or symptoms develop.
Danish: Patienterne skal informeres om tegn og symptomer på akut snævervinklet glaukom, og de skal informeres om at stoppe Trydonis og straks kontakte deres læge, hvis der opstår nogle af disse tegn og symptomer.
English: Depending on the type of anaesthetic, it may be necessary to stop using Trydonis at least 12 hours before the anaesthesia.
Danish: Afhængigt af typen af bedøvelse kan det være nødvendigt at stoppe med at bruge Trydonis i mindst 12 timer før bedøvelsen.
English: Talk to your doctor or pharmacist before using Trydonis:
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Trydonis:
English: There are no or limited amount of data from the use of Trydonis in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af Trydonis til gravide kvinder.
English: If you use more Trydonis than you should, side effects, as described in section 4, may occur.
Danish: Hvis du har brugt for meget Trydonis, kan der forekomme bivirkninger, som beskrevet i punkt 4.
English: Trydonis 87/5/9 mcg
Danish: Trydonis 87/5/9 mikrog
English: Related to Trydonis
Danish: Med relation til Trydonis
English: If anaesthesia with halogenated anaesthetics is planned, it should be ensured that Trydonis is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias.
Danish: Hvis der planlægges anæstesi med halogenerede anæstetika, skal det sikres, at Trydonis ikke administreres i mindst 12 timer før start af anæstesi, da der er en risiko for hjertearytmier.
English: Trydonis is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Danish: Trydonis er ikke indiceret til behandling af akutte episoder med bronkospasme eller til behandling af en akut forværring af KOL (det vil sige som akutbehandling).
English: 1 Adverse reactions reported in the SmPC of at least one of the individual components, but not observed as adverse reactions in the clinical development of Trydonis
Danish: 1 Bivirkninger rapporteret i produktresuméet for mindst én af de individuelle komponenter, men ikke observeret som bivirkninger under den kliniske udvikling af Trydonis
English: Trydonis is used as a maintenance treatment for your COPD.
Danish: Trydonis anvendes som vedligeholdelsesbehandling af din KOL.
English: Trydonis contains a small amount of ethanol.
Danish: Trydonis indeholder en mindre mængde alkohol.
English: This includes medicines similar to Trydonis used for your lung disease.
Danish: Dette gælder også for lægemidler, der ligner Trydonis og bruges til din lungesygdom.
English: Trydonis is unlikely to affect your ability to drive and use machines.
Danish: Det er ikke sandsynligt, at Trydonis vil påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Trydonis can be used at the recommended dose in patients with mild to moderate renal impairment.
Danish: Trydonis kan anvendes ved den anbefalede dosis hos patienter med let til moderat nedsat nyrefunktion.
English: Trydonis should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the foetus.
Danish: Trydonis bør kun anvendes under graviditeten, hvis de forventede fordele for patienten opvejer de mulige risici for fosteret.
English: Trydonis has no or negligible influence on the ability to drive and use machines.
Danish: Trydonis påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If you see 'mist' coming from the top of the inhaler or the sides of your mouth, this means that Trydonis will not be getting into your lungs as it should.
Danish: Hvis du ser en 'vandtåge' fra toppen af inhalatoren, eller fra mundvigene, betyder det, at Trydonis ikke kommer ned i lungerne, som det skal.
English: For glycopyrronium, the maximum plasma concentration was similar after administration of the fixed or extemporary combination, while the systemic exposure was slightly higher after administration of Trydonis than with the extemporary combination.
Danish: For glycopyrronium var den maksimale plasmakoncentration tilsvarende efter administration af den faste eller ekstemporære kombination, hvorimod den systemiske eksponering var lidt højere efter administration af Trydonis end med den ekstemporære kombination.
English: This study also investigated the potential pharmacokinetic interaction between the active components of Trydonis by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium.
Danish: Dette studie undersøgte også den mulige farmakokinetiske interaktion mellem de aktive komponenter af Trydonis ved at sammenligne de farmakokinetiske data, der blev opnået efter en enkeltdosis af den ekstemporære kombination, eller efter en enkeltdosis af de enkelte komponenter beclometasondipropionat/formoterol eller glycopyrronium.
English: If you have been using a different inhaler containing beclometasone dipropionate previously, ask your doctor for advice, as the effective dose of beclometasone dipropionate in Trydonis for the treatment of COPD may be lower than that of some other inhalers.
Danish: Hvis du tidligere har brugt en anden inhalator, der indeholdt beclometasondipropionat, skal du spørge lægen til råds, da den effektive dosis af beclometasondipropionat i Trydonis til behandling af KOL kan være lavere end dosis for andre inhalatorer.
English: Trydonis should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Danish: Trydonis skal straks seponeres og patienten vurderes med iværksættelse af alternativ behandling, hvis det er nødvendigt.