FrancophonIA/ELRC3.0 huggingface dataset:
English: As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications.
Danish: Da kvinder har tendens til et længere baseline QTc-interval end mænd, kan de være mere følsomme for lægemidler, der forlænger QTc.
English: Fareston contains the active substance toremifene, an anti-estrogen.
Danish: Fareston indeholder det aktive stof toremifen, et antiøstrogen.
English: The mean concentration of toremifene at steady-state is 0.9 (range 0.6 - 1.3) µg/ml at the recommended dose of 60 mg per day.
Danish: Den gennemsnitlige koncentration af toremifen ved steady state er 0,9 (variation 0,6-1,3) g/ml ved den anbefalede dosis på 60 mg dagligt.
English: Fareston contains lactose
Danish: Fareston indeholder lactose
English: Toremifene is a nonsteroidal triphenylethylene derivative.
Danish: Toremifen er et nonsteroidt triphenyletylenderivat.
English: Its steady-state concentrations are about twice compared to those of the parent compound.
Danish: Koncentrationen ved steady state er ca. to gange så høj, som for modersubstansen.
English: A QT clinical study with a 5-arm parallel design (placebo, moxifloxacin 400 mg, toremifene 20 mg, 80 mg, and 300 mg) has been performed in 250 male patients to characterize the effects of toremifene on the QTc interval duration.
Danish: Et klinisk QT-studie med et 5-armet parallelt design (placebo, moxifloxacin 400 mg, toremifen 20 mg, 80 mg og 300 mg) er udført hos 250 mandlige patienter for at karakterisere toremifens virkning på varigheden af QTc-intervallet.
English: The anti-tumour effect of toremifene in breast cancer is mainly due to the anti-estrogenic effect, although other mechanisms (changes in oncogene expression, growth factor secretion, induction of apoptosis and influence on cell cycle kinetics) may also be involved in the anti-tumour effect.
Danish: Antitumoreffekten af toremifen i brystkræft skyldes hovedsageligt den antiøstrogene effekt, skønt andre mekanismer (ændring i oncogent udtryk, vækstfaktorudskillelse, induktion af apoptose og indflydelse på cellecykluskinetik) også kan være involveret i antitumoreffekten.
English: If signs or symptoms that may be associated with cardiac arrhythmia occur during treatment with Fareston, treatment should be stopped and an ECG should be performed.
Danish: Hvis tegn eller symptomer, som kan sættes i forbindelse med hjertearytmier, opstår under behandling med Fareston, skal behandlingen seponeres, og der skal tages et ekg.
English: In some experimental cancers and/or using high-dose, toremifene displays anti-tumour effects which are not estrogen-dependent.
Danish: I visse eksperimentelle cancerformer og/eller ved høje doser udviser toremifen en antitumor effekt, som ikke er østrogenafhængig.
English: Concomitant use of those drugs with toremifene should be carefully considered.
Danish: Samtidig brug af disse lægemidler og torimefen skal derfor nøje overvejes.
English: The elimination of toremifene and its metabolites was significantly increased in patients with activated liver function and decreased in patients with impaired liver function.
Danish: Eliminationen af toremifen og dets metabolitter var signifikant øget hos patienter med aktiveret leverfunktion og nedsat hos patienter med nedsat leverfunktion.
English: Enzyme inducers, like phenobarbital, phenytoin and carbamazepine, may increase the rate of toremifene metabolism thus lowering the steady-state concentration in serum.
Danish: Enzyminduktorer som phenobarbital, phenytoin og carbamazepin kan øge metaboliseringen af toremifen og dermed nedsætte steady-state koncentrationen i serum.
English: Action potential studies in isolated rabbit heart have shown that toremifene induce cardiac electrophysiological changes which start to develop at concentrations approximately 10 fold compared to the calculated free therapeutic plasma concentration in human.
Danish: Aktionspotentialestudier i isolerede kaninhjerter har vist, at toremifen inducerer kardielle elektrofysiologiske forandringer, som begynder at udvikle sig ved koncentrationer, der er ca. 10 gange større sammenlignet med den kalkulerede frie terapeutiske plasmakoncentration hos mennesker.
English: In the acute and chronic toxicity studies most of the findings are related to the hormonal effects of toremifene.
Danish: I akutte og kroniske toksicitetsstudier kan de fleste fund relateres til den hormonale effekt af toremifen.
English: The results of this study show a clear positive effect of toremifene in the 80 mg group with mean prolongations of 21 - 26 ms.
Danish: Resultaterne fra dette studie viste en klar positiv virkning af toremifen i gruppen, der fik 80 mg med en gennemsnitlig forlængelse på 21 - 26 msek.
English: Your doctor will conduct regular medical checkups if you have high blood pressure, diabetes, have taken hormone replacement therapy or if you are obese (BMI over 30).
Danish: Din læge vil kontrollere dig regelmæssigt, hvis du har højt blodtryk, sukkersyge, har taget hormonerstatnings-behandling, eller hvis du er overvægtig (BMI over 30).
English: - if you have been told by your doctor that you have an intolerance to certain sugars, like lactose (see section 2 Fareston contains lactose).
Danish: - hvis din læge har fortalt dig, at du ikke kan tåle visse sukkerarter såsom lactose (se punkt 2 ”Fareston indeholder lactose”
English: In post-menopausal breast cancer patients, toremifene treatment is associated with modest reductions in both total serum cholesterol and low density lipoprotein (LDL).
Danish: Hos post-menopausale brystkræftpatienter er toremifenbehandling forbundet med en beskeden nedsættelse af total serumcholesterol og en nedsættelse af low density lipoprotein (LDL).
English: A few cases of hypercalcaemia have been reported in patients with bone metastases at the beginning of toremifene treatment.
Danish: Få tilfælde af hyperkalciæmi har været rapporteret hos patienter med knoglemetastaser i begyndelsen af toremifen behandlingen.
English: In repeated toxicity studies the cause of death in rats is gastric dilatation.
Danish: I gentagne toksicitetsstudier er dødsårsagen hos rotter ventrikeldilatation.
English: The reactions are usually mild and mostly due to the hormonal action of toremifene.
Danish: Disse reaktioner er sædvanligvis milde og hidrører oftest fra den hormonale effekt af toremifen.
English: 30 and 100 tablets.
Danish: 30 og 100 tabletter.
English: In general, however, nonsteroidal triphenylethylene derivatives are predominantly antiestrogenic in rats and man and estrogenic in mice.
Danish: I almindelighed er nonsteroide triphenyletylenderivater hovedsageligt antiøstrogene hos rotter og menneske og østrogene hos mus.
English: Three minor metabolites have been detected in human serum: (deaminohydroxy)toremifene, 4-hydroxytoremifene, and N,N-didemethyltoremifene.
Danish: Tre mindre metabolitter er fundet i humant serum: (deaminohydroxy)toremifen, 4hydroxytoremifen og N,N-didemethyltoremifen.
English: First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Danish: Primær hormonbehandling af hormonafhængig metastaserende brystcancer hos postmenopausale kvinder.
English: An additive effect on QT interval prolongation between Fareston and the following drugs and other medicinal products that may prolong the QTc interval cannot be excluded.
Danish: Der kan ikke udelukkes en additiv virkning på forlængelse af QT-intervallet mellem Fareston og følgende lægemidler og andre lægemidler, der kan forlænge QTc-intervallet.
English: Toremifene binds specifically to estrogen receptors, competitively with oestradiol, and inhibits estrogeninduced stimulation of DNA synthesis and cell replication.
Danish: Toremifen binder sig specifikt til østrogenreceptorer, kompetitivt med estradiol, og hæmmer den østrogeninducerede stimulation af DNA syntesen og cellereplikationen.
English: White, round, flat, bevelled edge tablet with TO 60 on one side.
Danish: Hvid, rund, flad, skråkantet tablet mærket TO 60 på den ene side.
English: Toremifene is administered orally.
Danish: Toremifen administreres oralt.
English: You should have gynaecological examinations before you start treatment with Fareston and at least once a year following the start of treatment with Fareston.
Danish: Du skal have foretaget en gynækologisk undersøgelse, før du påbegynder behandlingen med Fareston og derefter mindst 1 gang om året.
English: This might lead to an increased risk of ventricular arrhythmias, including Torsade de pointes.
Danish: Dette kan medføre en øget risiko for ventrikulære arytmier, herunder torsades de pointes.
English: Toremifene has a species-specific estrogen-like effect in mice and causes similar tumours.
Danish: Toremifen har en artsspecifik østrogen lignende effekt hos mus og forårsager lignende tumorer.
English: Non clinical in vitro and in vivo studies have evidenced the potential of toremifene and its metabolite to prolong cardiac repolarisation and this can be attributed to the blockade of hERG channels.
Danish: Ikke-kliniske in vitro- og in vivo-studier har påvist toremifens og dets metabolits potentiale for at forlænge kardial repolarisering, og denne egenskab kan henføres til blokaden af hERG-kanalerne.
English: If you forget to take Fareston
Danish: Hvis du har glemt at tage Fareston
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu..
English: Drugs which decrease renal calcium excretion, e.g. thiazide diuretics, may increase the risk of hypercalcaemia.
Danish: Lægemidler, der nedsætter den renale calciumudskillelse f.eks. thiazider, kan øge risikoen for hyperkalcæmi.
English: Enzyme complex, known to be responsible for the metabolism of toremifene in humans, is cytochrome P450-dependent hepatic mixed function oxidase.
Danish: Det enzymkomplex, der vides at metabolisere toremifen hos mennesket er cytochrom P450-afhængig leveroxidase med blandet funktion.
English: Green PVC foil and aluminium foil blister in a cardboard box.
Danish: Grøn PVC folie/aluminiumfolie blisterkort i karton.
English: Breast-feeding In rats, decreased body weight gain of the offspring during lactation was observed.
Danish: Amning Hos rotter er der observeret nedsat vægtstigning hos afkommet under laktation.
English: Thromboembolic events include deep venous thrombosis, thrombophlebitis and pulmonary embolism (see also section 4.4).
Danish: Tromboemboliske hændelser inkluderer dyb venethrombose, trombophlebitis og lungeemboli (se også pkt.
English: Cases of liver injury, including elevation of liver enzymes (> 10 times upper limit of normal), hepatitis and jaundice have been reported with toremifene.
Danish: Der er rapporteret tilfælde med leverskader, herunder forhøjede leverenzymer (> 10 gange den øvre normale grænse), hepatitis og gulsot ved behandling med toremifen.
English: These findings are postulated to be of little relevance for the safety in man, where toremifene acts mainly as an anti-estrogen.
Danish: Disse fund menes at være af ringe betydning formennesket, hvor toremifen hovedsagelig har en antiøstrogen effekt.
English: As other members of this class, e.g. tamoxifen and clomifene, toremifene binds to estrogen receptors and may produce estrogenic, anti-estrogenic or both effects, depending upon the duration of treatment, animal species, gender, target organ and variable selected.
Danish: Som andre medlemmer af denne klasse, dvs. tamoxifen og clomifen, binder toremifen sig til østrogenreceptorer og kan udøve østrogen, antiøstrogen eller begge effekter, afhængig af varighed af behandlingen, dyreart, køn og det valgte målorgan eller valgt undersøgelsesparameter.
English: AUTHORISATION · Periodic Safety Update Reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Fareston increases the QT interval in a dose-related manner (see also section 4.4).
Danish: Fareston øger QT-intervallet på en dosisrelateret måde (se også pkt.
English: Toremifene treatment has been associated with changes in liver enzyme levels (increases of transaminases) and in very rare occasions with more severe liver function abnormalities (jaundice).
Danish: Behandling med toremifen har været sat i forbindelse med ændringer i leverenzymniveauer (forhøjelse af aminotransferaser), samt i meget sjældne tilfælde med svære abnormiteter af leverfunktionen (gulsot).
English: Endometrial hypertrophy may develop during the treatment due to the partial estrogenic effect of toremifene.
Danish: Endometriehypertrofi kan udvikles under behandling med henvisning til den hormonale (partiel østrogene) effekt af toremifen.
English: Fareston causes certain abnormal changes in the electrical recording of the heart (electrocardiogram or ECG).
Danish: Fareston forårsager visse unormale forandringer i hjertets elektriske aktivitet (ses i elektrokardiogram (ekg)).
English: There are no systematic data available from patients with labile diabetes, from patients with severely altered performance status or from patients with cardiac failure.
Danish: Der er ingen tilgængelige kliniske data for patienter med labil diabetes, hos patienter med svær påvirket almen tilstand eller hos patienter med hjertefejl.
English: Theoretically the metabolism of toremifene is inhibited by drugs known to inhibit the CYP3A enzyme system which is reported to be responsible for its main metabolic pathways.
Danish: Teoretisk hæmmes metabolismen af toremifen af lægemidler, som hæmmer enzymsystemet CYP 3A, idet dette er rapporteret til at være dets hovedmetabolisme.
English: Very common side effects (may affect more than 1 in 10 people ) - hot flushes, sweating.
Danish: Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer) - hedeture, svedtendens.
English: If the QTc interval is > 500 ms, Fareston should not be used.
Danish: Hvis QT-intervallet er > 500 msek.
English: Pharmacokinetics of toremifene were investigated in an open study with four parallel groups of ten subjects: normal subjects, patients with impaired (mean AST 57 U/L - mean ALT 76 U/L - mean gamma GT 329 U/L) or activated liver function (mean AST 25 U/L - mean ALT 30 U/L - mean gamma GT 91 U/L - patients treated with antiepileptics) and patients with impaired renal function (creatinine: 176 µmol/L).
Danish: Toremifens farmakokinetiske egenskaber blev undersøgt i et åbent studie med fire parallel grupper af 10 forsøgs personer: raske forsøgs personer, patienter med nedsat (middel AST 57 U/l - middel ALT 76 U/l - middel gamma-GT 329 U/l) eller aktiveret leverfunktion (middel AST 25 U/l - middel ALT 30 U/l - middel gamma-GT 91 U/l - patienter behandlet med antiepileptika) og patienter med nedsat nyrefunktion (kreatinin: 176 µmol/l).
English: Package sizes: 30 and 100 tablets.
Danish: Pakningsstørrelse: 30 og 100 tabletter.
English: Frequency not known (cannot be estimated from the available data) - low number of white blood cells, which are important in fighting infection (leukopenia) - low number of red blood cells (anaemia) - low number of platelets (thrombocytopenia)
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data) - lavt antal af hvide blodlegemer, der er vigtige til bekæmpelse af infektion (leukopeni) - lavt antal af røde blodlegemer (blodmangel)
English: Anemia, leukopenia and thrombocytopenia have been reported.
Danish: Anæmi, leukopeni og trombocytopeni er rapporteret.
English: Patients with additional risk of endometrial cancer, e.g. patients suffering from hypertension or diabetes, having high BMI (> 30) or history of hormone replacement therapy should be closely monitored (see also section 4.8).
Danish: Patienter med særlig risiko for endometrial cancer, f.eks. patienter, der lider af hypertension eller diabetes, og som har et højt BMI (> 30) eller har været i længerevarende hormonbehandling, skal følges nøje (se også pkt.
English: The pattern of the liver damage was predominantly hepatocellular.
Danish: Leverskaderne var primært hepatocellulære.
English: Patients with a history of severe thromboembolic disease should generally not be treated with toremifene (see also section 4.8).
Danish: Patienter med kendte svære tromboemboliske sygdomme bør generelt ikke behandles med toremifen (se også pkt.
English: Pediatric population There is no relevant use of Fareston in the paediatric population.
Danish: Der er ingen relevante indikationer for Fareston i den pædiatriske population.
English: Hypercalcemia may occur at the beginning of toremifene treatment in patients with bone metastasis and thus these patients should be closely monitored.
Danish: Idet hypercalcæmi kan forekomme i starten af behandlingen hos patienter med knoglemetastaser, bør disse patienter derfor følges tæt.
English: Metabolism and nutrition disorders loss of appetite
Danish: Metabolisme og ernæring appetitlø shed
English: The main metabolic pathway, N-demethylation, is mediated mainly by CYP3A.
Danish: Hovedmetaboliseringen - N-demethyleringen - medieres via CYP 3A.
English: MARKETING AUTHORISATION NUMBERS EU/1/96/004/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/004/001
English: - Pre-existing endometrial hyperplasia and severe hepatic failure are contra-indications in long term use of toremifene.
Danish: - Tidligere forekommende endometriehyperplasi og svær leverinsufficiens kontraindicerer langtidsbrug af toremifen.
English: Red blood cell, leukocyte or platelet counts should be monitored when using Fareston.
Danish: Erytrocyt-, leukocyt- eller trombocyttælling bør monitoreres ved brug af Fareston.
English: For reasons of drug safety, toremifene is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances, particularly in uncorrected hypokalaemia
Danish: Med henblik på lægemiddelsikkerhed er Toremifen derfor kontraindiceret hos patienter med: Medfødt eller dokumenteret erhvervet QT-forlængelse Elektrolytforstyrrelser, især ukorrigeret hypokaliæmi Klinisk relevant bradykardi
English: INFORMATION IN BRAILLE fareston 60 mg
Danish: INFORMATION I BRAILLESKRIFT fareston 60 mg
English: The most frequent adverse reactions are hot flushes, sweating, uterine bleeding, leukorrhea, fatigue, nausea, rash, itching, dizziness and depression.
Danish: De mest almindelige bivirkninger er hedestigninger, svedeture, uterinblødning, leukorrhea, træthed, kvalme, udslæt, kløe, svimmelhed og depression.
English: Toremifene obeys linear serum kinetics at oral daily doses between 11 and 680 mg.
Danish: Toremifen følger en lineær serumkinetik ved peroral indtagelse af doser mellem 11 og 680 mg.
English: Fertility Toremifene is recommended for postmenopausal patients.
Danish: Fertilitet Toremifen er beregnet til postmenopausale kvinder.
English: Psychiatric disorders depression insomnia
Danish: Psykiske forstyrrelser depression søvnløsh ed
English: - Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to toremifene, in the form of QT prolongation.
Danish: - I både prækliniske undersøgelser og hos mennesker er der, efter udsættelse for toremifen, observeret ændringer i hjertets elektrofysiologi i form af QT-forlængelse.
English: Do not take Fareston together with the following medicines as there is an increased risk that your heartbeat may be altered (see section 2 Do not take Fareston): - medicines used to treat abnormal heart rhythm (antiarrhythmics); such as quinidine,
Danish: Du må ikke tage Fareston sammen med følgende medicin, da der er en øget risiko for, at det kan ændre din hjerterytme (se punkt 2 ”Tage ikke Fareston”): - medicin til behandling af rytmeforstyrrelser såsom quinidin, hydroquinidin, disopyramid,
English: Gynaecological examination should be performed before treatment administration, closely looking at pre-existing endometrial abnormality.
Danish: Gynækologisk undersøgelse, med nøje opmærksomhed på tidlig forekomst af endometrial abnormitet, bør foretages før behandling.
English: Fareston has been shown to prolong the QTc interval on the electrocardiogram in some patients in a dose-related manner.
Danish: Det er påvist, at Fareston hos nogle patienter forlænger QT-intervallet på elektrokardiogrammet på en dosisrelateret måde.
English: Common Uncommon Rare
Danish: Almindelig Ikke almindel ig
English: You should contact your doctor immediately if you notice any of the following: - swelling or tenderness in your calf - unexplained shortness of breath or sudden chest pain - vaginal bleeding or changes in vaginal discharge.
Danish: Du skal straks kontakte din læge, hvis du mærker et af følgende symptomer: - hævelse eller ømhed i læggen - uforklarlig kortåndethed eller smerter i brystet - blødning fra skeden eller forandringer i udflåd.
English: Fareston should be used with caution in patients with ongoing proarrhythmic conditions (especially elderly patients) such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl.
Danish: Fareston skal anvendes med forsigtighed hos patienter, der udviser proarytmiske tilstande (især ældre patienter) f.eks. akut myokardieiskæmi eller QT-forlængelse, da dette kan medføre en øget risiko for ventrikulære arytmier (herunder torsades de pointes) og hjertestop (se også pkt.
English: Fareston tablets contain lactose (28.5 mg/tablet).
Danish: Fareston tabletter indeholder lactose (28,5 mg/tablet).
English: In human serum the main metabolite is N-demethyltoremifene with mean half-life of 11 (range 4 - 20) days.
Danish: Toremifen metaboliseres i udstrakt grad. I humant serum er hovedmetabolitten N-demethyltoremifen med en middel halveringstid på 11 dage (variation 4-20 dage).
English: Fareston contains lactose (28.5 mg per tablet).
Danish: Fareston indeholder lactose (28,5 mg pr. tablet).
English: Very rare Not known
Danish: Ikke kendt
English: Driving and using machines Fareston has no influence on the ability to drive and use machines.
Danish: Trafik og arbejdssikkerhed Fareston har ingen indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: In mice, estrogens induce ovarian and testicular tumours as well as hyperostosis and osteosarcomas.
Danish: Hos mus inducerer østrogener ovarieog testikeltumorer ligesom hyperosteosis og osteosarcomer.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Renal impairment No dose adjustment is needed in patients with renal insufficiency.
Danish: Dosisjustering er ikke nødvendig hos patienter med nyreinsufficiens.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Orion Corporation
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Orion Corporation
English: What you need to know before you take Fareston
Danish: Det skal du vide, før du begynder at tage Fareston
English: In this study the kinetics of toremifene in patients with impaired renal function were not significantly altered as compared to normal subjects.
Danish: I dette studie sås ikke signifikant ændret kinetik af toremifen hos patienter med nedsat nyrefunktion når sammenlignet med raske personer.
English: Fareston is used for the treatment of a certain type of breast tumour in women who have had their menopause.
Danish: Fareston anvendes til behandling af visse former for brystkræft hos kvinder efter overgangsalderen.
English: The changes due to food intake are not clinically significant.
Danish: Denne forsinkelse er ikke klinisk signifikant.
English: posaconazole - medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin and telithromycin - medicines used to treat viral infection such as ritonavir and nelfinavir.
Danish: posaconazol, - medicin til behandling af bakterieinfektioner såsom erythromycin, clarithromycin og telithromycin - medicin til behandling af virusinfektioner såsom ritonavir og nelfinavir.
English: Respiratory, thoracic and mediastinal disorders dyspnoea
Danish: Luftveje, thorax og mediastinum dyspnø