FrancophonIA/ELRC3.0 huggingface dataset:
English: Kyntheum can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating psoriasis.
Danish: Kyntheum udleveres kun mod recept, og det bør anvendes under opsyn af en læge med erfaring i at diagnosticere og behandle psoriasis.
English: This compares with 6% of those given placebo and with 70% of patients given ustekinumab.
Danish: Dette skal sammenholdes med 6 % af dem, der fik placebo, og 70 % af dem, der fik ustekinumab.
English: Looking at the results of the 3 studies together, 85% of patients treated with Kyntheum obtained a 75% reduction in PASI scores (a measure of disease severity and area of skin affected) after 12 weeks.
Danish: Hvis man ser på resultaterne af alle tre undersøgelser samlet, opnåede 85 % af de patienter, der blev behandlet med Kyntheum, efter 12 uger en reduktion på 75 % i PASI-score (et mål for sygdommens sværhed og størrelsen af det angrebne hudområde).
English: What are the risks associated with Kyntheum?
Danish: Hvilke risici er der forbundet med Kyntheum?
English: Kyntheum must not be given to patients who have potentially serious infections such as tuberculosis and to patients with active Crohn's disease (an inflammatory disease affecting the gut).
Danish: Kyntheum må ikke gives til patienter med potentielt alvorlige infektioner som tuberkulose eller med aktiv Crohns sygdom (en inflammatorisk sygdom, der angriber tyktarmen).
English: Kyntheum should be stopped in patients who show new symptoms of depression or anxiety or in case they worsen.
Danish: Brug af Kyntheum bør stoppes hos patienter, der udviser nye symptomer på depression eller angst eller forværring af eksisterende symptomer.
English: It is used in adults whose disease is moderate to severe and who require systemic treatment (treatment with medicines given by mouth or by injection).
Danish: Det anvendes hos voksne med moderat til svær sygdom, som kræver behandling med lægemidler, der gives gennem munden eller ved injektion (systemisk behandling).
English: Side effects are similar to those of other medicines that target interleukin molecules.
Danish: Bivirkningerne svarer til bivirkningerne af andre lægemidler, der angriber interleukiner.
English: For the full list of all side effects and restrictions with Kyntheum, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Kyntheum fremgår af indlægssedlen.
English: For more information about treatment with Kyntheum, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kyntheum, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Also, 79% of patients given Kyntheum had clear or nearly clear skin after 12 weeks, compared with 3% of patients given placebo and 70% of patients given ustekinumab.
Danish: Efter 12 uger var huden hos 79 % af de patienter, der fik Kyntheum, desuden helet eller næsten helet, sammenholdt med 3 % af dem, der fik placebo, og 70 % af dem, der fik ustekinumab.
English: Kyntheum is a medicine used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Danish: Kyntheum er et lægemiddel, der anvendes til behandling af plaque-psoriasis, en sygdom, der giver røde, skællende hudpartier.
English: The doctor may decide to stop treatment if the condition does not improve after 12 to 16 weeks.
Danish: Hvis der ikke er bedring i patientens tilstand efter 12-16 uger, kan lægen beslutte at standse behandlingen.
English: Kyntheum is available as a solution for injection in pre-filled syringes.
Danish: Kyntheum leveres som injektionsvæske i fyldte sprøjter.
English: Plaque psoriasis improved to a greater extent in patients treated with Kyntheum than with placebo (a dummy treatment) or with ustekinumab (another medicine for psoriasis that targets interleukin molecules).
Danish: Hos de patienter, der blev behandlet med Kyntheum, var der større bedring i plaque-psoriasis end hos dem, der fik virkningsløs behandling (placebo) eller et andet psoriasismiddel, som angriber interleukiner (ustekinumab).
English: Interleukins 17 are involved in the process of inflammation that causes plaque psoriasis.
Danish: Stoffer af typen interleukin 17 er medvirkende til den betændelsesproces, der er årsag til plaque-psoriasis.
English: For practical information about using Kyntheum, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kyntheum, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Kyntheum used?
Danish: Hvordan anvendes Kyntheum?
English: What benefits of Kyntheum have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kyntheum?
English: How does Kyntheum work?
Danish: Hvordan virker Kyntheum?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kyntheum have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er anført anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Kyntheum.
English: By blocking the action of interleukin 17 substances, brodalumab reduces the inflammation and symptoms associated with the disease.
Danish: Brodalumab reducerer inflammation og symptomer ved sygdommen ved at blokere virkningen af stoffer af typen interleukin
English: The full EPAR for Kisplyx can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Kisplyx findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Kisplyx is available as capsules (4 mg and 10 mg).
Danish: Kisplyx fås som kapsler (4 mg og 10 mg).
English: This is a summary of the European public assessment report (EPAR) for Kisplyx.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Kisplyx.
English: The recommended dose is 18 mg (made up of one 10 mg capsule and two 4 mg capsules) once a day at the same time each day in combination with 5 mg of everolimus once a day.
Danish: Den anbefalede dosis er 18 mg (bestående af én 10 mgkapsel og to 4 mg-kapsler) én gang dagligt på samme tidspunkt hver dag i kombination med 5 mg everolimus én gang dagligt.
English: Other information about Kisplyx
Danish: Andre oplysninger om Kisplyx
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Kisplyx's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Kisplyx opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is Kisplyx and what is it used for?
Danish: Hvad er Kisplyx, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Kisplyx?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kisplyx?
English: By blocking these enzymes, lenvatinib can block the formation of new blood vessels, cutting off the blood supply that keeps cancer cells growing, and reduce the growth of the cancer.
Danish: Ved at blokere disse enzymer kan lenvatinib standse dannelsen af nye blodkar og derved afskære den blodforsyning til kræftcellerne, der gør det muligt for dem at vokse.
English: Kisplyx can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in using cancer medicines.
Danish: Kisplyx udleveres kun efter recept, og behandlingen skal iværksættes og overvåges af en læge med erfaring i brug af kræftmedicin.
English: Why is Kisplyx approved?
Danish: Hvorfor blev Kisplyx godkendt?
English: Treatment is given for as long as the patient benefits from it or until side effects become unacceptable.
Danish: Behandlingen gives, så længe patienten har fordel af den, eller indtil patienten får bivirkninger, som ikke kan tolereres.
English: Kisplyx contains the active substance lenvatinib.
Danish: Kisplyx indeholder det aktive stof lenvatinib.
English: Patients who took the combination of Kisplyx and everolimus lived for an average of 14.6 months without their disease getting worse, compared with 7.4 months for the patients who took Kisplyx alone and 5.5 months for the patients who took everolimus alone.
Danish: Hos de patienter, der fik en kombination af Kisplyx og everolimus, gik der i gennemsnit 14,6 måneder, inden sygdommen forværredes, mens der hos de patienter, der fik Kisplyx alene, gik 7,4 måneder, og hos de patienter, der fik everolimus alene, 5,5 måneder.
English: The dose of Kisplyx should be decreased in patients with severely reduced kidney or liver function.
Danish: Dosen af Kisplyx bør nedsættes hos patienter med svært nedsat nyre- eller leverfunktion.
English: It is not intended to provide practical advice on how to use Kisplyx.
Danish: Det er ikke en praktisk vejledning i, hvordan Kisplyx bør anvendes.
English: Previously treated patients with advanced renal cell carcinoma have poor outcomes and a high unmet medical need.
Danish: Tidligere behandlede patienter med fremskredent renalcellekarcinom har dårlige prognoser og et stort udækket medicinsk behov.
English: Kisplyx must not be taken by breastfeeding women.
Danish: Kisplyx må ikke anvendes af kvinder, der ammer.
English: What are the risks associated with Kisplyx?
Danish: Hvilke risici er der forbundet med Kisplyx?
English: For more information about treatment with Kisplyx, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kisplyx, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The study compared the combination of Kisplyx and everolimus with Kisplyx or everolimus alone.
Danish: Undersøgelsen sammenlignede en kombination af Kisplyx og everolimus med Kisplyx og/eller everolimus alene.
English: Kisplyx is used together with another cancer medicine called everolimus.
Danish: Kisplyx anvendes sammen med et andet kræftlægemiddel, der kaldes everolimus.
English: The safety of Kisplyx used in combination with everolimus is similar to that of these medicines when used individually, and side effects are considered manageable.
Danish: Sikkerheden ved Kisplyx anvendt i kombination med everolimus er den samme som sikkerheden ved hvert af de to lægemidler anvendt alene, og bivirkningerne vurderes at være håndterbare.
English: The main measure of effectiveness was how long the patients lived without their disease getting worse (progression-free survival).
Danish: Det primære mål for virkning var progressionsfri overlevelse (den tid, patienterne lever uden forværring af sygdommen).
English: Kisplyx has been investigated in one main study involving 153 adults with advanced renal cell carcinoma that had got worse despite treatment with a VEGF inhibitor.
Danish: Kisplyx er vurderet i en hovedundersøgelse, hvori der deltog 153 voksne patienter med fremskredent renalcellekarcinom, som var blevet værre på trods af behandling med en VEGF-hæmmer.
English: The most common side effects with Kisplyx, when used in combination with everolimus or alone and which may affect more than 3 in 10 people, are diarrhoea, high blood pressure, tiredness, loss of appetite and weight, vomiting, nausea (feeling sick), proteinuria (protein in the urine), stomatitis (inflammation of the lining of the mouth), headache, dysphonia (speech disturbances), palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), peripheral oedema (swelling, especially of the ankles and feet) and hypercholesterolemia (high levels of cholesterol [type of fat] in the blood).
Danish: De hyppigste bivirkninger ved Kisplyx, når det anvendes i kombination med everolimus eller alene, og som kan forekomme hos flere end 3 ud af 10 patienter, er diarré, forhøjet blodtryk, træthed, appetitløshed, vægttab, opkastning, kvalme, proteinuri (protein i urinen), mundbetændelse, hovedpine, talebesvær, hånd-fod-syndrom (der omfatter udslæt og følelsesløshed på håndflader og fodsåler), perifert ødem (hævelse af især ankler og fødder) og forhøjet kolesterol.
English: Kisplyx is a cancer medicine used to treat adults with advanced renal cell carcinoma (a type of kidney cancer) who have been previously treated with a type of cancer medicine called a ‘vascular endothelial growth factor (VEGF) inhibitor'.
Danish: Kisplyx er et lægemiddel mod kræft, der anvendes til behandling af voksne patienter med fremskredent renalcellekarcinom (en type nyrekræft), som tidligere er blevet behandlet med et kræftmiddel, der kaldes "vaskulær endotelial vækstfaktor (VEGF)-hæmmer".
English: The active substance in Kisplyx, lenvatinib, is a ‘tyrosine-kinase inhibitor'.
Danish: Det aktive stof i Kisplyx, lenvatinib, er en såkaldt tyrosinkinasehæmmer.
English: The dose of Kisplyx may need to be reduced or treatment stopped temporarily if certain side effects occur.
Danish: Dosen af Kisplyx kan nedsættes eller behandlingen stoppes midlertidigt, hvis patienten får uacceptable bivirkninger.
English: This means that it blocks the activity of enzymes known as tyrosine kinases.
Danish: Det vil sige, at stoffet blokerer enzymer af typen tyrosinkinaser.
English: Kisplyx, used in combination with everolimus, was shown to significantly improve the time these patients lived without their disease getting worse.
Danish: Det er påvist, at Kisplyx i kombination med everolimus markant forbedrer den tid, patienterne har at leve i uden sygdomsprogression.
English: The most important serious side effects are kidney failure and reduced kidney function; problems with the heart and circulation such as heart failure and blood clots in the arteries leading to stroke or heart attack; bleeding in the brain or bleeding of a tumour within the skull; a syndrome known as ‘posterior reversible encephalopathy syndrome' characterised by headache, confusion, fits and loss of vision; and liver failure.
Danish: De alvorligste bivirkninger er nyresvigt og nedsat nyrefunktion, hjerte- og kredsløbsproblemer, herunder hjertesvigt, blodpropper i arterierne med deraf følgende slagtilfælde eller hjerteanfald, hjerneblødning eller blødning i en svulst i kraniet, et sygdomskompleks med hovedpine, forvirring, krampeanfald og synstab (posteriort reversibelt encefalopatisyndrom) samt leversvigt.
English: For practical information about using Kisplyx, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kisplyx, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Kisplyx have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kisplyx?
English: How is Kisplyx used?
Danish: Hvordan anvendes Kisplyx?
English: For the list of all side effects reported with everolimus, see the package leaflet of the medicine containing everolimus.
Danish: Listen over indberettede bivirkninger ved everolimus fremgår af indlægssedlen for det everolimus-holdige lægemiddel.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kisplyx have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Kisplyx.
English: For further information, see the package leaflets for Kisplyx and the medicine containing everolimus.
Danish: De nærmere oplysninger fremgår af indlægssedlen for Kisplyx og det lægemiddel, der indeholder everolimus.
English: How does Kisplyx work?
Danish: Hvordan virker Kisplyx?
English: For the full list of all side effects reported with Kisplyx, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Kisplyx fremgår af indlægssedlen.
English: These enzymes can be found in certain receptors (such as VEGF, FGFR, PDGF, KIT and RET receptors) in cancer cells, where they activate several processes including cell division and the growth of new blood vessels.
Danish: Disse enzymer findes i bestemte receptorer i kræftceller, herunder de såkaldte VEGF-, FGFR-, PDGF-, KIT- og RET-receptorer.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
English: In addition to the side effects listed above, chest pain has also been reported.
Danish: Foruden de ovennævnte bivirkninger er der også indberettet brystsmerter.
English: They may cause a decrease in placental perfusion, foetal electrolyte disturbances and possibly other reactions that have occurred in the adults.
Danish: De kan forårsage nedsat placentaperfusion, elektrolytforstyrrelser hos fostret og muligvis også andre reaktioner, der er forekommet hos voksne.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, Lapp-lactase eller glucose-galactosemalabsorption bør ikke anvende dette lægemiddel.
English: It is also important to tell your doctor if you are taking other medicines to reduce your blood pressure, steroids, medicines to treat cancer, pain killers or arthritis medicines.
Danish: Det er også vigtigt at fortælle lægen, hvis du tager anden medicin for at nedsætte blodtrykket, steroider, kræftmedicin, smertestillende medicin eller gigtmedicin.
English: Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Danish: Det kan være nødvendigt, at øge dosis af probenecid eller sulfinpyrazon.
English: Irbesartan: there was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Danish: Irbesartan: Der var ikke tegn på abnorm systemisk eller målorgan-toksicitet ved klinisk relevante doser.
English: Table 3: Adverse reactions (regardless of relationship to medicinal product) reported with the use of hydrochlorothiazide alone
Danish: Tabel 3: Bivirkninger (uden hensyn til forbindelse med lægemidlet) rapporteret ved anvendelse af hydrochlorthiazid alene
English: Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased;
Danish: Kortikosteroider, ACTH: Elektrolytdepletion, specielt hypokaliæmi, kan forstærkes;
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 January 2007
Danish: Dato for første markedsføringstilladelse: 19. januar 2007 Dato for seneste genregistrering:
English: * Frequency for adverse reactions detected by spontaneous reports is described as “not known”
Danish: *Hyppigheden af bivirkninger rapporteret efter markedsføring er angivet som “ikke kendt”.
English: Irbesartan Hydrochlorothiazide BMS should not be given to children and adolescents (under 18 years).
Danish: Irbesartan Hydrochlorothiazide BMS må ikke gives til børn og unge (under 18 år).
English: Irbesartan/hydrochlorothiazide: the potential toxicity of the irbesartan/hydrochlorothiazide combination after oral administration was evaluated in rats and macaques in studies lasting up to 6 months.
Danish: Irbesartan/hydrochlorthiazid: Potentiel toksicitet for irbesartan/hydrochlorthiazid-kombinationen efter oral administration blev undersøgt hos rotter og makakaber i studier af op til 6 måneders varighed.
English: Non-steroidal anti-inflammatory drugs: the administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients;
Danish: Non-steroide antiinflammatoriske lægemidler: Administration af et non-steroidt antiinflammatorisk lægemiddel kan reducere den diuretiske, natriuretiske og antihypertensive virkning af thiaziddiuretika hos nogle patienter;
English: Table 2: Adverse reactions reported with the use of irbesartan alone General disorders and administration site conditions:
Danish: Tabel 2: Bivirkninger rapporteret ved anvendelse af irbesartan alene Almene symptomer og reaktioner på administrationsstedet:
English: Pressor amines (e.g. noradrenaline): the effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Danish: Aminer der sænker blodtrykket (fx noradrenalin): Virkningen af aminer, der sænker blodtrykket kan nedsættes, men ikke tilstrækkeligt til at udelukke deres anvendelse;
English: Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Irbesartan Hydrochlorothiazide BMS.
Danish: Yderligere information om de individuelle stoffer: Udover ovenfor nævnte bivirkninger for kombinationspræparatet, kan andre tidligere rapporterede bivirkninger i forbindelse med ét af de individuelle stoffer være potentielle bivirkninger ved Irbesartan Hydrochlorothiazide BMS.
English: transient blurred vision, xanthopsia
Danish: Forbigående sløret syn, xanthopsia
English: Antidiabetic medicinal products (oral agents and insulins): dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Danish: Antidiabetiske lægemidler (orale stoffer og insuliner): Det kan være nødvendigt at dosisjustere den antidiabetiske behandling (se pkt.
English: Irbesartan Hydrochlorothiazide BMS is unlikely to affect your ability to drive or use machines.
Danish: Irbesartan Hydrochlorothiazide BMS påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner.
English: Do not take Irbesartan Hydrochlorothiazide BMS if you are allergic (hypersensitive) to irbesartan or any of the other ingredients of Irbesartan Hydrochlorothiazide BMS if you are allergic (hypersensitive) to hydrochlorothiazide or any other sulfonamide-derived medicines if you are more than 3 months pregnant.
Danish: Brug ikke Irbesartan Hydrochlorothiazide BMS: hvis du er overfølsom (allergisk) over for irbesartan eller et af de andre indholdsstoffer i Irbesartan Hydrochlorothiazide BMS hvis du er overfølsom (allergisk) over for hydrochlorthiazid eller over for sulfonamidholdig medicin hvis du er længere end 3. måned henne i din graviditet.
English: These lesions were not observed in macaques; decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
Danish: Disse læsioner blev ikke observeret hos makakaber; et fald i serum-kalium på grund af hydrochlorthiazid og delvis forebyggelse, når hydrochlorthiazid blev givet i kombination med irbesartan.
English: If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du er intolerant over for bestemte sukkerarter, bør du kontakte lægen inden du bruger denne medicin.
English: While this is not documented with Irbesartan Hydrochlorothiazide BMS, a similar effect should be anticipated.
Danish: Selvom dette ikke er dokumenteret for Irbesartan Hydrochlorothiazide BMS, kan der forventes en tilsvarende effekt.
English: Newcastle Upon Tyne Tyne & Wear NE3 3TT United Kingdom
Danish: Newcastle Upon Tyne, Tyne & Wear NE3 3TT Storbritannien
English: Following oral administration of Irbesartan Hydrochlorothiazide BMS, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Danish: Ved oral administration af Irbesartan Hydrochlorothiazide BMS er den absolutte orale biotilgængelighed 60-80% for irbesartan og 50-80% for hydrochlorthiazid.