FrancophonIA/ELRC3.0 huggingface dataset:
English: Among the 61 patients treated at an initial dose of 300 mg/m2/day, the overall response rate, according to a global assessment by the physician, was 51% (31/61) with a clinical complete response rate of 3%.
Danish: Blandt de 61 patienter behandlede med en indledende dosis på 300 mg/m2/dag var den overordnede respons rate ifølge lægens globale vurdering 51% (31/61) med en klinisk fuldstændig respons rate på 3%.
English: Particular care should be taken in patients with a history of depression.
Danish: Der bør udvises særlig forsigtighed hos patienter med tidligere tilfælde af depression.
English: Based on data from ongoing clinical trials, elevation of LFTs resolved within one month in 80% of patients following a decrease in dose or discontinuation of therapy.
Danish: På baggrund af oplysninger fra igangværende, kliniske forsøg bør LFT-forhøjelsen for 80% af patienters vedkommende være afklaret inden for en måned efter mindskning af dosen eller afbrydelse af terapien.
English: Swelling of legs and arms.
Danish: Hævelse af ben og arme.
English: The aetiology of this finding is unknown.
Danish: Ætiologien af dette fund er ukendt.
English: Responses were also determined by a composite score of five clinical signs (surface area, erythema, plaque elevation, scaling and hypo/hyperpigmentation) which also considered all extracutaneous CTCL manifestations.
Danish: Respons blev også fastslået ved sammenlægning af fem kliniske tegn (overfladeareal, erythema, plakforhøjelse, skorpedannelse, og hypo-/hyperpigmentering), der også tog hensyn til alle ekstrakutane CTCL-manifestationer.
English: The use of some retinoids has been associated with photosensitivity.
Danish: Anvendelsen af visse retinoider er sat i forbindelse med lysfølsomhed.
English: Whenever contraception is required, it is recommended that two reliable forms of contraception be used simultaneously.
Danish: Når prævention er påkrævet, anbefales det at anvende to pålidelige præventionsmidler samtidigt.
English: • gemfibrozil (used to reduce high levels of fats in the blood such as triglycerides and cholesterol),
Danish: • gemfibrozil (anvendes til nedbringelse af højt niveau af fedt i blodet såsom kolesterol og triglycerider),
English: Minimise exposure to sunlight as much as possible and avoid exposure to sun lamps.
Danish: Du skal så vidt muligt undgå sollys og undgå brug af solarium eller højfjeldssol.
English: Take your prescribed number of capsules at the same time each day with a meal.
Danish: Tag det ordinerede antal Targretin-kapsler på samme tidspunkt hver dag sammen med et måltid.
English: There are no adequate data from the use of bexarotene in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af bexaroten hos gravide kvinder.
English: Allergic Reaction Infection Chills Abdominal Pain Hormone Level Altered
Danish: Allergisk reaktion Infektion Kulderystelser Abdominalsmerter Ændret hormonalt niveau
English: There are insufficient data to evaluate potential differences in the pharmacokinetics of bexarotene for other races.
Danish: Der er utilstrækkelige data til at kunne evaluere de potentielle forskelle i bexarotenes farmakokinetik for andre racer.
English: It may be asymptomatic and responds to treatment with thyroxine and resolves upon withdrawal of treatment.
Danish: Den kan være asymptomatisk og reagerer på behandling med thyroxin.
English: High-density polyethylene bottles with child-resistant closures containing 100 capsules.
Danish: Flasker af polyethylen med høj tæthed og børnesikret lukning indeholdende 100 kapsler.
English: However, the exact mechanism of action of bexarotene in the treatment of cutaneous T-cell lymphoma (CTCL) is unknown.
Danish: Bexarotens nøjagtige virkningsmekanisme i behandlingen af kutant T-celle-lymfom (CTCL) er dog ukendt.
English: Headache, fatigue, pain.
Danish: Hovedpine, træthed, smerte.
English: If you forget to take one dose, take your daily dose with your next meal on the same day, then take your usual dose as normal, the following day.
Danish: Hvis du glemmer at tage en dosis, skal du tage din daglige dosis med dit næste måltid samme dag.
English: With appropriate clinical monitoring, individual patients may benefit from doses above 300 mg/m 2/day.
Danish: Under behørigt, klinisk opsyn kan enkelte patienter drage nytte af doser på over 300 mg/m 2/dag.
English: Targretin may be harmful to a developing foetus.
Danish: Targretin kan være skadeligt for et foster under udvikling.
English: Do not take a double dose in one day to make up for a forgotten dose the previous day.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Effective contraception must be used from the time of the negative pregnancy test through the initiation of therapy, during therapy and for at least one month following discontinuation of therapy.
Danish: Virksom prævention bør anvendes fra den negative graviditetsprøve gennem indledningen af terapiforløbet, under forløbet og mindst en måned efter terapiens afbrydelse.
English: Body Weight and Gender: Based on the population pharmacokinetics analysis of data for 614 patients with a weight range of 26 to 145 kg, the bexarotene apparent clearance increases with increasing body weight.
Danish: Kropsvægt og køn: Baseret på farmakokinetiske populationsdata for 614 patienter med en kropsvægt på 26-145 kg stiger bexarotenes tilsyneladende clearance med stigende kropsvægt.
English: Bexarotene has a different adverse reaction profile to other oral, non-retinoid X receptor (RXR)-selective retinoids.
Danish: Bexaroten har en anderledes bivirkningsprofil end andre orale, ikke-retinoide X-receptor (RXR)selektive retinoidlægemidler.
English: The capsule should not be chewed.
Danish: Kapslen må ikke tygges.
English: - if you are pregnant or breast feeding or if you can become pregnant and are not using effective birth control measures.
Danish: - hvis du er gravid eller ammer, eller hvis du kan blive gravid og ikke anvender effektive, præventive forholdsregler.
English: Targretin capsules should be used with caution in patients with a known hypersensitivity to retinoids.
Danish: Targretin-kapsler bør anvendes med forsigtighed hos patienter med kendt overfølsomhed overfor retinoider.
English: Bexarotene should not be used in breast-feeding mothers.
Danish: Bexaroten bør ikke anvendes af ammende mødre.
English: OUTER CARTON TEXT AND BOTTLE LABEL TEXT
Danish: TEKST PÅ YDRE KARTON OG TEKST PÅ MEDICINFLASKEETIKET
English: Depression, depression aggravated, anxiety, and mood alterations have been reported in patients treated with systemic retinoids, including bexarotene.
Danish: Der er rapporteret depression, forværret depression, angst og humørsvingninger hos patienter, der blev behandlet med systemiske retinoider, herunder bexaroten.
English: Gender has no statistically significant effect on bexarotene pharmacokinetics.
Danish: Køn har ingen statistisk signifikant virkning på bexarotenes farmakokinetik.
English: The estimated renal clearance of bexarotene is less than 1 ml/minute.
Danish: Den anslåede, renale clearance for bexaroten er mindre end 1 ml/minut.
English: This is because taking Targretin may affect your mood.
Danish: Det kan nemlig påvirke dit humør at tage Targretin.
English: Patients should be advised to minimise exposure to sunlight and avoid sun lamps during therapy with bexarotene, as in vitro data indicate that bexarotene may potentially have a photosensitising effect.
Danish: Patienter bør rådes til at mindske udsættelsen for sollys og til at undgå solarier og højfjeldssole under terapiforløb med bexaroten, idet in vitro-data antyder, at bexaroten muligvis har en lysfølsomhedsfremmende virkning.
English: Changes in thyroid function tests have been observed in patients receiving bexarotene, most often noted as a reversible reduction in thyroid hormone (total thyroxine [total T4]) and thyroid-stimulating hormone (TSH) levels.
Danish: Der er observeret ændringer i thyroideafunktionsprøver hos patienter, som indtager bexaroten, oftest i form af en reversibel niveaureduktion af thyroideahormon (total thyroxin [total T4]) og thyroideastimulerende hormon (TSH).
English: Effects of bexarotene on other substances
Danish: Bexarotens virkninger på andre stoffer
English: CTCL is a condition in which certain cells of the body's lymph system called T-lymphocytes become cancerous and affect the skin.
Danish: CTCL er en lidelse, hvor visse celler i kroppens lymfesystem, kendt under betegnelsen T-lymfocytter, bliver ramt af kræft og påvirker huden.
English: Bexarotene is contraindicated in pregnancy (see section 4.3).
Danish: Bexaroten er kontraindiceret ved graviditet (se pkt.
English: Laboratory test interactions CA125 assay values in patients with ovarian cancer may be accentuated with bexarotene therapy.
Danish: Interaktioner ved laboratorieprøver CA125 assay-værdier hos patienter med ovariecancer kan accentueres gennem bexaroten-terapi.
English: Elevations of serum cholesterol should be managed according to current medical practice.
Danish: Forhøjelse af serumkolesterol bør reguleres i henhold til gældende, lægelig praksis.
English: Table 1 Recommended initial dose Initial dose level (300 mg/m2/day)
Danish: Tabel 1 Anbefalet indledende dosering Indledende doseringsniveau (300 mg/ m2/dag)
English: The ability of the RXRs to form heterodimers with various receptor partners that are important in cellular function and in physiology indicates that the biological activities of bexarotene are more diverse than those of compounds that activate the RARs.
Danish: RXR'ernes mulighed for at danne heterodimer i forbindelse med adskillige receptorer, som er af betydning for cellefunktion og fysiologi, antyder at bexarotens biologiske aktiviteter er mere mangeartede end de forbindelser, som aktiverer RAR'erne.
English: In view of the limited data, patients with renal insufficiency should be monitored carefully while on bexarotene therapy.
Danish: I lyset af de begrænsede oplysninger bør patienter med nedsat nyrefunktion overvåges omhyggeligt under terapiforløb med bexaroten.
English: No formal studies have been conducted in patients with renal insufficiency.
Danish: Der foreligger ingen formelle studier af patienter med nedsat nyrefunktion.
English: The capsules should be swallowed whole and not chewed.
Danish: Kapslerne bør sluges hele og ikke tygges.
English: Capsule content: macrogol polysorbate povidone butylated hydroxyanisole
Danish: Kapselindhold: macrogol polysorbat povidon butyleret hydroxyanisol
English: Patients who experience dizziness or visual difficulties during therapy must not drive or operate machinery.
Danish: Patienter, som oplever svimmelhed eller synsbesvær under behandlingsforløbet, må ikke føre motorkøretøj eller betjene maskiner.
English: Elevation of blood fats (triglycerides and cholesterol).
Danish: Forhøjet niveau af fedtstoffer i blodet (triglycerider og kolesterol).
English: Thus, if treatment with bexarotene is intended in a woman of childbearing potential, a reliable, non-hormonal form of contraception is also required, because bexarotene belongs to a therapeutic class for which the human malformative risk is high.
Danish: Hvis behandling med bexaroten er beregnet til en kvinde i den fødedygtige alder, er en pålidelig, ikke-hormonal form for prævention således også påkrævet, da bexaroten tilhører en terapeutisk gruppe, hvor risikoen for misdannelser hos mennesker er stor.
English: Effects of other substances on bexarotene
Danish: Andre stoffers virkninger på bexaroten
English: Age: Based on the population pharmacokinetic analysis of data for 232 patients aged ≥ 65 years and 343 patients aged < 65 years, age has no statistically significant effect on bexarotene pharmacokinetics.
Danish: Alder: Baseret på data fra farmakokinetiske populationsanalyser fra 232 patienter i alderen ≥ 65 år og 343 patienter i alderen < 65 år har alder ingen statistisk signifikant virkning på bexarotens farmakokinetik.
English: Thus, if treatment with bexarotene is intended in a woman with childbearing potential, a reliable, non-hormonal contraceptive method is also recommended.
Danish: Hvis behandling med bexaroten er beregnet til en fødedygtig kvinde, tilrådes en pålidelig, ikke-hormonal præventionsmetode derfor også.
English: The safety and efficacy of bexarotene in children (aged below 18 years) have not been established.
Danish: Bexarotens kliniske sikkerhed og virkning hos børn (under 18 år) er ikke klarlagt.
English: Therefore, repeated administration of bexarotene may result in an auto-induction of its own metabolism and, particularly at dose levels greater than 300 mg/m2/day, may increase the rate of metabolism and reduce plasma concentrations of other substances metabolised by cytochrome P450 3A4, such as tamoxifen.
Danish: Gentagen indtagelse af bexaroten kan derfor medføre en selvinduktion af dets eget metabolisme, og kan specielt på dosisniveauer på mere end 300 mg/m2/dag øge metaboliseringshastigheden og reducere plasmakoncentrationerne af andre stoffer, der metaboliseres ved hjælp af cytokrom P450 3A4, så som tamoxifen.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Any patient treated with bexarotene who experiences visual difficulties should have an appropriate ophthalmologic examination.
Danish: Enhver bexaroten-behandlet patient, som får synsproblemer, bør få foretaget en behørig oftalmologisk undersøgelse.
English: The safety of bexarotene has been examined in clinical studies of 193 patients with CTCL who received bexarotene for up to 118 weeks and in 420 non-CTCL cancer patients in other studies.
Danish: Bexarotens sikkerhed er undersøgt ved kliniske undersøgelser af 193 CTCL-patienter, som indtog bexaroten i op til 118 uger, og af 420 ikke-CTCL-cancerpatienter i andre undersøgelser.
English: Targretin is available as soft capsules for oral use in a white plastic bottle containing 100 capsules.
Danish: Targretin fås som bløde kapsler til indtagelse gennem munden, og leveres i hvide plastikflasker indeholdende 100 kapsler.
English: Following repeat once daily dose administration at dose levels  230 mg/m2, Cmax and AUC in some patients were less than respective single dose values.
Danish: Efter gentagen, enkeltstående, daglig indtagelse ved doseringsniveauer på  230 mg/m2 var Cmax og AUC for nogle patienters vedkommende lavere end de respektive enkeltdosisværdier.
English: System Organ Class (MedDRA terminology
Danish: Systemorgan -klasse MedDRAterminologi
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Targretin, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: However, among a total of 810 patients, including those without malignancy, treated with bexarotene, there were three serious adverse reactions with fatal outcome (acute pancreatitis, subdural haematoma and liver failure).
Danish: Det bør dog bemærkes, at der blandt en samlet gruppe på 810 patienterherunder patienter uden malignitet - som behandledes med bexaroten, forekom tre alvorlige bivirkninger med dødelig udgang (akut pankreatitis, subduralt hæmatom og leversvigt).
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Male patients with sexual partners who are pregnant, possibly pregnant, or may potentially become pregnant must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose.
Danish: Mandlige patienter, hvis sexpartnere er gravide, muligvis er gravide, eller muligvis kan blive gravide, bør anvende præservativer under samleje, så længe der indtages bexaroten og mindst en måned efter sidste dosis.
English: • erythromycin, clarithromycin and rifampicin (used against bacterial infections),
Danish: • erythromycin, clarithromycin og rifampicin (anvendes mod bakterielle infektioner),
English: Following bexarotene treatment, some patients were observed to have previously undetected lens opacities or a change in pre-existing lens opacities unrelated to treatment duration or dose level of exposure.
Danish: Efter behandling med bexaroten udviste nogle patienter en tidligere ubemærket linseopacitet eller en forandring i allerede tilstedeværende linseopacitet, uafhængigt af behandlingens varighed eller doseringsniveau.
English: The active substance in Targretin, bexarotene, belongs to a group of medicines known as retinoids, which are related to vitamin A.
Danish: Det virksomme stof i Targretin, bexaroten, tilhører en gruppe af lægemidler, som er kendt under betegnelsen retinoider.
English: Under similar conditions, bexarotene concentrations were not affected by concomitant administration of atorvastatin or levothyroxine.
Danish: Under tilsvarende omstændigheder påvirkedes bexarotenkoncentrationen ikke af samtidig indtagelse af atorvastatin eller levothyroxin.
English: No clinical experience with an overdose of Targretin has been reported.
Danish: Der er ikke rapporteret tilfælde af overdosering af Targretin.
English: Targretin should be taken with food (see section 3).
Danish: Brug af Targretin sammen med mad og drikke Targretin skal tages sammen med mad (se punkt 3).
English: Based on the known mechanism of action, bexarotene may potentially enhance the action of these agents, resulting in hypoglycaemia.
Danish: På baggrund af lægemidlets kendte virkningsmekanisme kan bexaroten muligvis fremme disse stoffers virkning, hvilket kan medføre hypoglykæmi.
English: In vivo, bexarotene causes tumour regression in some animal models and prevents tumour induction in others.
Danish: In vivo forårsager bexaroten svulstregression hos visse dyrearter og forhindrer svulstinduktion hos andre.
English: Ataxia Neuropathy Vertigo Hyperaesthesia Depression Agitation
Danish: Ataksi Neuropati Vertigo Hyperæstesi Depression Agitation
English: Patients with CTCL having risk factors for pancreatitis (e.g., prior episodes of pancreatitis, uncontrolled hyperlipidaemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease, and medications known to increase triglyceride levels or to be associated with pancreatic toxicity) should not be treated with bexarotene, unless the potential benefit outweighs the risk.
Danish: CTCL-patienter med risikofaktorer for pankreatitis (f.eks. tidligere tilfælde af pankreatitis, ukontrolleret hyperlipidæmi, stort alkoholforbrug, ukontrolleret diabetes mellitus, sygdomme i galdevejene, eller lægemidler, hvorom det vides, at de forhøjer triglyceridniveauet eller er forbundet med pankreas-toksicitet) bør ikke behandles med bexaroten, med mindre de potentielle fordele opvejer de foreliggende risici.
English: Bexarotene, in common with the majority of retinoids, was teratogenic and embryotoxic in an animal test species at systemic exposures that are achievable clinically in humans.
Danish: Som de fleste andre retinoider er bexaroten teratogent og embryotoksisk hos dyrearter, som undersøgtes ved systemiske eksponeringsgrader, som er klinisk opnåelige blandt mennesker.
English: You must use effective contraception (birth control) continuously starting one month before beginning therapy until one month after you stop taking Targretin.
Danish: Du skal anvende effektiv prævention (svangerskabsforebyggende middel) hele tiden fra en måned før til en måned efter behandling med Targretin.
English: In all evaluated patients, the estimated renal clearance of bexarotene was less than 1 ml/minute.
Danish: Hos alle evaluerede patienter var den anslåede renale clearance mindre end 1 ml/minut.
English: Albuminuria Kidney Function Abnormal
Danish: Albuminuri Abnorm nyrefunktion
English: In vitro studies suggest glucuronidation as a metabolic pathway, and that cytochrome P450 3A4 is the major cytochrome P450 isozyme responsible for formation of the oxidative metabolites.
Danish: In vitro-undersøgelser antyder glukuronidering som en metabolisk vej, samt at cytokrom P450 3A4 er det væsentligste cytokrom P450-isozym med ansvar for dannelsen af oxidative metabolitter.
English: - if you are allergic to bexarotene or any of the other ingredients of this medicine (listed in section
Danish: - hvis du er allergisk over for bexaroten eller et af de øvrige indholdsstoffer i Targretin (angivet i punkt 6).
English: How long you should take Targretin
Danish: Hvor længe du skal tage Targretin
English: Swelling, bleeding, high blood pressure, fast heart rate, visible vein enlargement, dilation of blood vessels.
Danish: Hævelse, blødning, højt blodtryk, hurtigt hjerteslag, synlig blodåreforstørrelse, udvidelse af blodkar.
English: Butylated hydroxyanisole, an ingredient in Targretin, may cause irritation to the mucous membranes, therefore the capsules must be swallowed intact and not chewed.
Danish: Butyleret hydroxyanisol, som er en af ingredienserne i Targretin, kan forårsage irritation af slimhinderne, hvorfor kapslerne skal sluges hele og ikke tygges.
English: If you experience dizziness or problems with your vision during therapy, do not drive or operate machinery.
Danish: Hvis du oplever svimmelhed eller synsproblemer under behandlingen, må du ikke køre bil eller betjene maskiner.
English: The recommended initial dose is 300 mg/m 2/day.
Danish: Den anbefalede, indledende dosis er 300 mg/m 2/dag.
English: Chills, abdominal pain, allergic reaction, infection.
Danish: Kulderystelser, mavesmerte, allergisk reaktion, infektion.
English: Dizziness Hypesthesia Insomnia
Danish: Svimmelhed Hypæstesi Søvnløshed
English: Targretin contains a small amount of sorbitol, therefore patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Targretin indeholder en lille mængde sorbitol og bør ikke anvendes til patienter med arvelig fructoseintolerans.
English: Clinical pharmacokinetic data indicate that urinary elimination of bexarotene and its metabolites is a minor excretory pathway for bexarotene.
Danish: Kliniske, farmakokinetiske data antyder, at renal udskillelse af bexaroten og dets metabolitter er en mindre væsentlig ekskretorisk vej for bexaroten.
English: In male dogs, some effects have been documented (see section 5.3).
Danish: Hos hanhunde er der dokumenteret nogen effekt (se pkt.
English: When bexarotene was administered for six months to sexually mature dogs, no testicular effects were seen.
Danish: Ved kønsmodne hundes indtagelse af bexaroten over en seks måneder lang periode bemærkedes der ingen virkninger på testis.
English: The following Targretin-related adverse reactions were reported during clinical studies in patients with CTCL (N=109) treated at the recommended initial dose of 300 mg/m2/day.
Danish: De følgende lægemiddelrelaterede bivirkninger rapporteredes under kliniske undersøgelser af CTCL-patienter (N=109), som behandledes med den anbefalede indledende dosis på 300 mg/m²/dag.
English: Low red blood cell count, enlarged lymph nodes, worsening of lymphoma.
Danish: Lavt antal røde blodceller, forstørrede lymfeknuder, forværret lymfom.
English: Doses greater than 650 mg/m 2/day have not been evaluated in patients with CTCL.
Danish: Der er ikke foretaget evaluering af doser på mere end 650 mg/m2/dag for CTCL-patienters vedkommende.
English: Race: Based on the population pharmacokinetic analysis of data for 540 Caucasian and 44 Black patients, bexarotene pharmacokinetics are similar in Blacks and Caucasians.
Danish: Race: Baseret på farmakokinetiske populationsdata for 540 kaukasiske patienter og 44 sorte patienter er bexarotenes farmakokinetik identisk hos de to racer.
English: No formal studies to evaluate interactions with bexarotene have been conducted.
Danish: Der er ikke foretaget formelle undersøgelser med henblik på at evaluere bexarotens lægemiddelinteraktion.