FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients receiving bazedoxifene monotherapy there have been post-marketing reports of visual symptoms such as visual acuity disturbance or blurred vision.
Danish: Efter markedsføring er der rapporteret synsrelaterede symptomer såsom nedsat synsskarphed eller sløret syn hos patienter, der fik bazedoxifen som monoterapi.
English: Very common: may affect more than 1 in 10 people • Abdominal pain (stomach ache)
Danish: Meget almindelige: kan forekomme hos flere end 1 ud af 10 personer • Mavesmerter
English: The effect of CE/BZA on the risk of dementia is unknown.
Danish: Virkningen af konjugerede østrogener/bazedoxifen på risikoen for demens er ukendt.
English: - CE/BZA must not be taken by women of childbearing potential, or breast-feeding women
Danish: - Konjugerede østrogener/bazedoxifen må ikke tages af kvinder i den fødedygtige alder eller kvinder, der ammer (se pkt.
English: - Active or past history of venous thromboembolism (e.g., deep venous thrombosis,
Danish: - Aktiv eller tidligere venøs tromboemboli (f. eks. dyb venetrombose, lungeemboli og retinal venetrombose).
English: Reproductive toxicity and impairment of fertility studies with CE/BZA have not been conducted.
Danish: Der er ikke udført forsøg af reproduktiv toksicitet og nedsat fertilitet med konjugerede østrogener/bazedoxifen.
English: The metabolic disposition of CE and BZA, after administration of CE/BZA, has not been studied.
Danish: Den metaboliske fordeling af konjugerede østrogener og bazedoxifen efter administration af konjugerede østrogener /bazedoxifen er ikke blevet undersøgt.
English: The pharmacokinetics of CE/BZA have not been evaluated in patients with renal impairment.
Danish: De farmakokinetiske egenskaber ved konjugerede østrogener/bazedoxifen er ikke blevet vurderet hos patienter med nedsat nyrefunktion.
English: Each modified-release tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene
Danish: Hver tablet med modificeret udløsning indeholder 0,45 mg konjugerede østrogener og bazedoxifenacetat svarende til 20 mg bazedoxifen
English: Each modified-release tablet contains 0.45 mg of conjugated oestrogens and bazedoxifene acetate equivalent to 20 mg bazedoxifene.
Danish: Hver tablet med modificeret udløsning indeholder 0,45 mg konjugerede østrogener og bazedoxifenacetat svarende til 20 mg bazedoxifen.
English: • Vaginal inflammation
Danish: • Bækkensmerter
English: Stroke
Danish: Hedeture
English: • Enlargement of hepatic haemangiomas, a benign (non-cancerous) tumour of the liver
Danish: • Forstørrelse af blodcyste i leveren, dvs. en godartet svulst i leveren
English: • Headache
Danish: • Hedeture
English: Cardiac disorders
Danish: Koronar arteriesygdom
English: • Drowsiness
Danish: • Svimmelhed
English: Excipients with known effect
Danish: Tabel med bivirkninger
English: Herbal preparations containing St John's wort (Hypericum perforatum) may induce the metabolism of oestrogens.
Danish: Naturmedicin, der indeholder perikon, kan øge østrogenmetabolismen.
English: Common: may affect 1 in 10 people
Danish: Almindelige: kan forekomme hos op til 1 ud af 10 personer
English: Adverse reactions that have been observed with CE monotherapy
Danish: Bivirkninger, der er observeret med konjugerede østrogener som monoterapi.
English: Randomised controlled data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy.
Danish: Randomiserede kontrollede data viste ikke en øget risiko for hjerte-karsygdomme hos kvinder, som har fået fjernet deres livmoder, og som kun tager østrogen.
English: The effect of DUAVIVE on the risk of ovarian cancer is unknown.
Danish: Det vides ikke om Duavive har nogen indvirkning på risikoen for kræft i æggestokkene.
English: CE/BZA is contraindicated in these patients (see section 4.3).
Danish: Konjugerede østrogener/bazedoxifen er kontraindiceret til disse patienter (se pkt.
English: Should a VTE event occur or be suspected, CE/BZA should be discontinued immediately.
Danish: Hvis venøs tromboemboliske hændelse forekommer, eller der er formodning om VTE, skal konjugerede østrogener/bazedoxifen straks seponeres.
English: Hypertension
Danish: Risikoratio
English: The effect of CE/BZA on the risk of ovarian cancer is unknown.
Danish: Virkningen af konjugerede østrogener/bazedoxifen på risikoen for ovariecancer er ukendt.
English: Use in this population is not recommended (see sections 4.2 and 5.2).
Danish: Anvendelse til denne population frarådes (se pkt.
English: Leiomyoma (uterine fibroids) or endometriosis Risk factors for thromboembolic disorders (see below) Risk factors for oestrogen-dependent tumours, e.g., 1
Danish: - Leiomyoma (uterusfibromer) eller endometriose - Risikofaktorer for tromboemboliske sygdomme (se nedenfor) - Risikofaktorer for østrogenafhængige tumorer, f. eks. arvelig brystcancer i nærmeste familie - Hypertension - Leversygdomme (f. eks. leveradenom) - Diabetes mellitus med eller uden vaskulære komplikationer - Cholelithiasis - Migræne eller (svær) hovedpine - Systemisk lupus erythematosus - Endometriehyperplasi i anamnesen (se nedenfor) - Epilepsi - Astma - Otosklerose.
English: The effect of CE/BZA on the risk of breast cancer is unknown.
Danish: Virkningen af konjugerede østrogener/bazedoxifen på risikoen for brystcancer er ukendt.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren
English: Muscle spasms
Danish: Muskel-spasmer
English: - CE/BZA has not been studied in patients with impaired liver function (see sections 4.2 and 5.2) or history of cholestatic jaundice.
Danish: 4.2 og 5.2) eller cholestatisk gulsot i anamnesen.
English: Use of CE/BZA in this population is contraindicated (see sections 4.2, 4.3 and 4.4).
Danish: Anvendelse til denne population er kontraindiceret (se pkt.
English: • seizures (epilepsy)
Danish: • epileptiske anfald
English: Should a stroke occur or be suspected, CE/BZA should be discontinued immediately (see section 4.3).
Danish: Hvis der foreligger apopleksi, eller der er formodning om apopleksi, skal konjugerede østrogener/bazedoxifen straks seponeres (se pkt.
English: This is important as using more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Danish: Det er vigtigt, da samtidig brug af mere end et lægemiddel kan forstærke eller svække lægemidlernes virkning.
English: The doctor will prescribe a suitable dose for you.
Danish: Lægen vil ordinere en passende dosis til dig.
English: Awareness by family or friends may be useful to detect mental health deterioration.
Danish: Familiens eller venners opmærksomhed kan være nyttig til registrering af en forværring af den mentale sundhed.
English: Your doctor will advise you on what to do.
Danish: Din læge vil fortælle dig, hvad der bør gøres.
English: Treatment should be continued as long as the patient is deriving benefit.
Danish: Behandlingen bør fortsættes, så længe patienten drager nytte af den.
English: Although some patients have improvement within the first several weeks, most patients require several months or more of treatment to improve.
Danish: Selvom nogle patienter oplever bedring inden for de første uger, har de fleste patienter behov for behandling i flere måneder eller mere for at opnå bedring.
English: Contains sorbitol.
Danish: Indeholder sorbitol.
English: You may not notice some changes in your mood and behaviour and so it is very important that you tell your friends and family that this medicine could affect your mood and behaviour.
Danish: Du bemærker muligvis ikke selv visse ændringer i dit humør og din opførsel, så det er meget vigtigt, at du fortæller dine venner og din familie, at dette lægemiddel kan påvirke dit humør og din opførsel.
English: 60528 Frankfurt am Main Germany
Danish: 60528 Frankfurt am Main Tyskland
English: Manufacturer Eisai Manufacturing Limited Mosquito Way Hatfield
Danish: Eisai Manufacturing Limited Mosquito Way Hatfield
English: Terminal elimination half-life values were generally between one and three hours.
Danish: Halveringstiden for den terminale eliminering var generelt mellem en og tre timer.
English: Hypothyroidism generally occurs 4-8 weeks after commencement of therapy.
Danish: Hypothyroidisme indtræder almindeligvis 4-8 uger efter terapiens påbegyndelse.
English: The mechanism of this interaction is unknown.
Danish: Denne interaktionsmekanisme er ukendt.
English: Do not take more than 15,000 International Units of vitamin A supplements per day during treatment.
Danish: Tag ikke mere end 15.000 internationale enheder vitamin A som tilskud pr. dag under behandlingen.
English: No evidence of prolonged accumulation was observed.
Danish: Der observeredes intet bevis for forlænget akkumulation.
English: Sometimes it is necessary to adjust the dose or interrupt treatment.
Danish: Nogle gange er det nødvendigt at justere dosen eller afbryde behandlingen.
English: Bexarotene is not genotoxic.
Danish: Bexaroten er ikke genotoksisk.
English: Tell your doctor as soon as possible if you feel any deterioration in your condition while you are taking Targretin.
Danish: Fortæl det til din læge hurtigst muligt, hvis du føler en forværring af din tilstand, mens du tager Targretin.
English: Patients should be monitored for signs of depression and referred for appropriate treatment if necessary.
Danish: Patienter bør overvåges for tegn på depression og om nødvendigt henvises til relevant behandling.
English: Initial dose calculations according to body surface area are as follows:
Danish: Beregning af indledende doser, afhængigt af kropsoverflade, er som følger:
English: The recommended dose is generally 4 to 10 capsules to be taken once daily.
Danish: Den anbefalede dosis er som regel er 4-10 kapsler, som indtages én gang dagligt.
English: 60528 Frankfurt am Main Germany e-mail: medinfo_de@eisai.net
Danish: 60528 Frankfurt am Main Tyskland e-mail: medinfo_de@eisai.net
English: The frequencies of adverse reactions are classified as very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), and very rare (<1/10,000).
Danish: Bivirkningernes forekomst er klassificeret som meget almindelig (>1/10), almindelig (>1/100, <1/10), ikke almindelig (>1/1.000, <1/100), sjælden (>1/10.000, <1/1.000) og meget sjælden (<1/10.000).
English: They may notice these changes and help you identify any problems that you need to talk to your doctor about.
Danish: De kan bemærke disse ændringer og hjælpe dig med at finde ud af, om du har problemer, som du skal tale med lægen om.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Carcinogenicity studies have not been conducted.
Danish: Der er ikke foretaget undersøgelser vedrørende carcinogenicitet.
English: The standard dose should be used in the elderly.
Danish: Standarddoseringen bør anvendes hos ældre patienter.
English: Patients with diabetes mellitus
Danish: Patienter med diabetes mellitus
English: Any overdose should be treated with supportive care for the signs and symptoms exhibited by the patient.
Danish: Enhver overdosis bør behandles med støttende omsorg for patientens udviste tegn og symptomer.
English: Your doctor should determine how long you should take Targretin, and when treatment may be stopped.
Danish: Din læge vil afgøre, hvor længe du skal tage Targretin, og hvornår behandlingen skal standses.
English: Patients receiving bexarotene should not donate blood for transfusion.
Danish: Patienter, som indtager bexaroten, bør ikke donere blod til transfusion.
English: Every attempt should be made to maintain triglyceride levels below 4.52 mmol/l in order to reduce the risk of clinical sequelae.
Danish: Der bør gøres alle bestræbelser for at opretholde triglyceridniveauer på under 4,52 mmol/l med henblik på at mindske risikoen for kliniske sequelae.
English: Total daily dose (mg/day)
Danish: Total, daglig dosis (mg/dag)
English: Protein binding/distribution: bexarotene is highly bound (>99%) to plasma proteins.
Danish: Proteinbinding/distribution: Bexaroten er i høj grad (>99%) bundet til plasmaproteiner.
English: DO NOT use Targretin if you are pregnant or breast-feeding.
Danish: Tag IKKE Targretin, hvis du er gravid eller ammer.
English: - if you have ever had any mental health problems including depression, aggressive tendencies or mood changes.
Danish: - hvis du nogensinde tidligere har haft problemer med din mentale sundhed, herunder depression, aggressive tendenser eller humørsvingninger.
English: If you regularly consume grapefruit or grapefruit juice, please consult your doctor as these have the potential to alter your body's response to Targretin therapy.
Danish: Hvis du har et regelmæssigt forbrug af grapefrugt eller grapefrugtjuice, bedes du kontakte din læge, da disse eventuelt kan ændre kroppens reaktion på Targretin-terapi.
English: If you are taking a hormonal contraceptive (for example, birth control pills), you should discuss this with your doctor.
Danish: Hvis du tager et hormonalt præventionsmiddel (for eksempel p-piller), skal du drøfte dette med din læge.
English: Do not stop taking your medication until your doctor advises you to do so.
Danish: Du må ikke stoppe med at tage din medicin, før lægen råder dig til det.
English: Body Surface Area (m
Danish: Kropsoverflade (m
English: Children and adolescents Targretin capsules should not be used in children or adolescents.
Danish: Børn og unge Targretin-kapsler bør ikke anvendes til børn og unge.
English: Do not store above 30
Danish: Må ikke opbevares over 30
English: Effects on fertility cannot be excluded.
Danish: Påvirkning af fertilitet kan ikke udelukkes.
English: Very common (can occur in more than 1 in 10 patients treated): Low white blood cell count.
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 behandlede): Lavt antal hvide blodceller.
English: The capsules can be taken immediately before, during or immediately after the course of the meal, if preferred.
Danish: Kapslerne kan tages umiddelbart før, under eller efter måltidet, alt efter behag.
English: Of the total number of patients with CTCL in clinical studies, 61% were 60 years or older, while 30% were 70 years or older.
Danish: Ud af det samlede antal CTCL-patienter i kliniske undersøgelser var 61% 60 år eller ældre, mens 30% var 70 år eller ældre.
English: Common (can occur in up to 1 in 10 patients treated):
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 behandlede):
English: Food interactions
Danish: Fødevareinteraktioner
English: Targretin capsules should be taken as a single oral daily dose with a meal.
Danish: Targretin-kapsler skal tages som en enkelt oral, daglig dosis i forbindelse med et måltid.
English: Because of the relationship of bexarotene to vitamin A, patients should be advised to limit vitamin A supplements to 15,000 IU/day to avoid potential additive toxic effects.
Danish: Grundet bexarotens forhold til A-vitamin bør patienter rådes til at begrænse A-vitamintilskud til 15.000 IE/dag, for at undgå mulige, additive, toksiske virkninger.
English: Table 2 Adverse reactions reported in patients in clinical trials
Danish: Tabel 2 Bivirkninger rapporteret hos patienter i kliniske forsøg
English: Ongoing systemic infection.
Danish: Vedvarende, systemisk infektion
English: Paediatric population Targretin is not recommended in children (aged below 18 years).
Danish: Pædiatrisk population Targretin anbefales ikke til børn (under 18 år).
English: Mental health problems
Danish: Problemer med mental sundhed
English: Once activated, these receptors function as transcription factors that regulate processes such as cellular differentiation and proliferation, apoptosis, and insulin sensitisation.
Danish: Efter aktivering fungerer disse receptorer som transkriptionsfaktorer, som regulerer processer såsom celledifferentiering og -proliferation, apoptose og insulinsensibilisering.
English: It is not known whether Targretin has an effect on your ability to drive a car or operate machinery.
Danish: Det vides ikke, om Targretin påvirker evnen til at føre bil eller betjene maskiner.
English: Renal excretion is not a significant elimination pathway for bexarotene.
Danish: Renal ekskretion udgør ingen væsentlig eliminationsvej for bexaroten.
English: It is recommended that two reliable forms of contraception be used together.
Danish: Det anbefales at anvende to pålidelige former for prævention samtidigt.
English: If you are capable of becoming pregnant, you must have a pregnancy test within one week before you start therapy, confirming you are not pregnant.
Danish: Hvis du kan blive gravid, skal du udføre en graviditetsprøve inden for en uge, inden du påbegynder behandlingen, for at bekræfte at du ikke er gravid.
English: Date of latest renewal: 24 April 2006.
Danish: Dato for første markedsføringstilladelse: 29 marts 2001 Dato for seneste fornyelse: 24 april 2006
English: Marketing Authorisation Holder Eisai GmbH
Danish: Indehaveren af markedsføringstilladelsen Eisai GmbH
English: It is unknown whether bexarotene is excreted in human milk.
Danish: Det er ukendt, om bexaroten udskilles i human mælk.
English: To be swallowed whole.
Danish: Skal sluges hele
English: In all clinical trials, patients were instructed to take Targretin capsules with or immediately following a meal.
Danish: I alle kliniske undersøgelser pålagdes patienterne at indtage Targretin-kapsler med, eller umiddelbart efter, et måltid.
English: Metabolism: bexarotene metabolites in plasma include 6- and 7-hydroxy-bexarotene and 6- and 7-oxo-bexarotene.
Danish: Metabolisme: Bexaroten-metabolitter, som forekommer i plasma, omfatter 6- og 7-hydroxybexaroten såvel som 6- og 7-oxo-bexaroten.
English: No clinical instances of cross-reactivity have been noted.
Danish: Der er ikke noteret kliniske tilfælde af krydsreaktivitet.
English: Absorption/dose proportionality: pharmacokinetics were linear up to a dose of 650 mg/m2.
Danish: Absorption/doseringsproportionalitet: Farmakokinetikken var lineær ved doser på op til 650 mg/m2.
English: There are indications that bexarotene may induce CYP3A4.
Danish: Det tyder på, at bexaroten kan inducere CYP3A4.
English: When toxicity is controlled, doses may be carefully readjusted upward.
Danish: Når der er opnået kontrol over toksiciteten, kan doseringen forsigtigt genjusteres opad.
English: Name and address of the manufacturer responsible for batch release Eisai Manufacturing Limited
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Eisai Manufacturing Limited
English: However, dizziness and visual difficulties have been reported in patients taking Targretin.
Danish: Svimmelhed og synsbesvær er imidlertid rapporteret hos patienter, der tager Targretin.
English: A negative, sensitive, pregnancy test (e.g. serum beta-human chorionic gonadotropin, beta-HCG) should be obtained within one week prior to bexarotene therapy.
Danish: En negativ, følsom, graviditetsprøve (f.eks. serum-beta-humant choriongonadotropin, beta-HCG) bør foretages inden for en uge inden påbegyndelsen af bexaroten-terapi.
English: Single doses of 1500 mg/kg (9000 mg/m 2) and 720 mg/kg (14,400 mg/m 2) were tolerated without significant toxicity in rats and dogs, respectively.
Danish: Enkelte doser på 1500 mg/kg (9000 mg/m2) og 720 mg/kg (14.400 mg/m tolereredes uden væsentlig toksicitet hos henholdsvis rotter og hunde.
English: Do not take Targretin:
Danish: Tag ikke Targretin:
English: Do not store above 30C.
Danish: Må ikke opbevares ved temperaturer over 30 C.
English: Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikkelægemidlet efter den udløbsdato, der står på pakningen.
English: Bexarotene is a synthetic compound that exerts its biological action through selective binding and activation of the three RXRs: , , and .
Danish: Virkningsmekanisme Bexaroten er en syntetisk forbindelse, som udøver sin biologiske virkning gennem selektiv binding og aktivering af de tre RXR'er: , og .
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX25
Danish: Farmakoterapeutisk klassifikation: andre antineoplastiske stoffer ATC-kode: L01XX25
English: Because safety and efficacy data from clinical trials are based upon administration with food, it is recommended that Targretin capsules be administered with food.
Danish: Da de sikkerheds- og virkningsmæssige oplysninger fra kliniske forsøg er baseret på samtidig indtagelse med fødevarer, anbefales det, at Targretin-kapsler indtages med fødevarer.
English: Targretin contains sorbitol and butylated hydroxyanisole Targretin contains a small amount of sorbitol (a type of sugar).
Danish: Targretin indeholder sorbitol og butyleret hydroxyanisol Targretin indeholder en lille mængde sorbitol (en slags sukker).
English: The majority of cases resolved after dose reduction or discontinuation of treatment.
Danish: Flertallet af tilfældene blev afhjulpet efter nedsættelse af dosen eller afbrydelse af behandlingen.
English: If this medicinal product is used inadvertently during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be informed of the potential hazard to the foetus.
Danish: Hvis lægemidlet uforvarende anvendes under graviditet, eller hvis patienten bliver gravid, mens lægemidlet indtages, bør vedkommende oplyses om den mulige fare for fosteret.
English: Studies in animals have shown reproductive toxicity.
Danish: Dyrestudier har vist reproduktionstoksicitet.
English: Based on the comparison of animal and patient exposures to bexarotene, a margin of safety for human teratogenicity has not been demonstrated (see section 5.3).
Danish: På baggrund af sammenligning af bexarotens indvirkning på dyr og patienter er der ikke påvist nogen sikkerhedsmargin for menneskelig teratogenicitet (se pkt.
English: Excretion: neither bexarotene nor its metabolites are excreted in urine in any appreciable amounts.
Danish: Ekskretion: Hverken bexaroten eller dets metabolitter udskilles i væsentlige mængder gennem urin.
English: Fasting triglycerides should be normal or normalised with appropriate intervention prior to bexarotene therapy.
Danish: Fastende triglycerider bør være normale eller normaliseret gennem forholdsmæssig intervention forud for bexaroten-terapi.
English: Proteins in urine, abnormal kidney function.
Danish: Proteiner i urinen, abnorm nyrefunktion.
English: Pharmacokinetics in Special Populations
Danish: Farmakokinetiske egenskaber hos særlige populationer
English: Bexarotene therapy should only be initiated and maintained by physicians experienced in the treatment of patients with CTCL.
Danish: Bexaroten-terapi bør kun indledes og fortsættes af læger med erfaring indenfor behandling af CTCL-patienter.
English: • tamoxifen (used against some forms of cancer),
Danish: • tamoxifen (anvendes mod visse former for kræft),
English: Fertility studies have not been conducted; however, in sexually immature male dogs, reversible aspermatogenesis (28-day study) and testicular degeneration (91-day study) were seen.
Danish: Der er ikke foretaget fertilitetsundersøgelser, men hos endnu ikke kønsmodne hanhunde er der konstateret reversibel aspermatogenese (28-dages undersøgelse) samt testisdegeneration (91dages undersøgelse).
English: The overall response rate according to this composite assessment was 31% (19/61) with a clinical complete response rate of 7% (4/61).
Danish: I følge den sammenlagte vurdering var den overordnede respons rate 31% (19/61) med en fuldstændig klinisk respons rate på 7% (4/61).