FrancophonIA/ELRC3.0 huggingface dataset:
English: Toremifene is eliminated mainly as metabolites to the faeces.
Danish: Toremifen udskilles hovedsageligt som metabolitter i fæces.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/004/001 30 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/004/001 30 tabletter EU/1/96/004/002 100 tabletter
English: Toremifene should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Danish: Det frarådes at anvende toremifen samtidig med andre lægemidler, der forlænger QT-intervallet (se også pkt.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactase mangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: - Clinically relevant bradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrhythmias.
Danish: Klinisk relevant hjertesvigt med nedsat uddrivningsfraktion fra venstre ventrikel Symptomatiske arytmier i anamnesen.
English: In particular please tell your doctor if you are taking any of the following: - water tablets (diuretics of thiazide type) - medicines to prevent blood clotting such as warfarin - medicines used to treat epilepsy such as carbamazepine, phenytoin, phenobarbital - medicines used to treat fungal infections such as ketoconazole, itraconazole, voriconazole,
Danish: Du skal især fortælle det til lægen, hvis du tager følgende medicin: - vanddrivende medicin (af thiazidtypen), - medicin for at modvirke blodpropper såsom warfarin, - medicin til behandling af epilepsi såsom carbamazepin, phenytoin, phenobarbital, - medicin til behandling af svampeinfektioner såsom ketoconazol, itraconazol, voriconazol,
English: endometrial cancer
Danish: endometriecance
English: Rare (≥ 1/10,000 to < 1/1,000)
Danish: Sjælden (>1/10.000 til 1/1.000)
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT · Risk Management Plan (RMP)
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET Risikostyringsplan (RMP) Ikke relevant
English: Nervous system disorders dizziness headache
Danish: Nervesystemet svimmelhed hovedpi ne
English: Examples of such drugs are antifungal imidazoles (ketoconazole); other antifungal agents (itraconazole, voriconazole, posaconazole); protease inhibitors (ritonavir, nelfinavir), macrolides (clarithromycin, erythromycin, telithromycine).
Danish: Eksempler på sådanne lægemidler er antimykotiske imidazoler (ketoconazol), andre antimykotika (itraconazol, voriconazol, posaconazol), proteasehæmmere (ritonavir, nelfinavir), makrolider (clarithromycin, erythromycin, telithromycin).
English: (hypokalaemia) which are currently not corrected by treatment - if you have a very slow heart rate (bradycardia) - if you have a heart failure - if you have a history of abnormal heart rhythms (arrhythmias) - if you are taking other medicines that may affect your heart (see section 2 Other medicines and
Danish: (hypokaliæmi), som endnu ikke er blevet behandlet - hvis du har en meget langsom hjerterytme (puls) - hvis du har hjertesvigt - hvis du tidligere har haft unormal hjerterytme (arytmi) - hvis du tager andre lægemidler, som kan påvirke dit hjerte (se punkt 2 ”Brug af anden medicin sammen med Fareston”)
English: Hepatic impairment Toremifene should be used cautiously in patients with liver impairment (see section 5.2).
Danish: Toremifen bør anvendes med forsigtighed hos patienter med nedsat leverfunktion (se pkt.
English: - inflammation of the liver (hepatitis).
Danish: - lavt antal af blodplader (tendens til blødning) - leverbetændelse (hepatitis).
English: Fareston should not be used during pregnancy.
Danish: Det frarådes at anvende Fareston under graviditet.
English: PHARMACEUTICAL FORM Tablet.
Danish: Tablet.
English: microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.
Danish: mikrokrystallinsk cellulose, kolloid vandfri sillica og magnesiumstearat.
English: Sodium starch glycolate Magnesium stearate Cellulose, microcrystalline Silica, colloidal anhydrous.
Danish: Natriumstivelsesglycolat Magnesiumstearat Cellulose, mikrokrystallinsk Silica, kolloid vandfri.
English: If you stop taking Fareston The treatment with Fareston should only be stopped when advised by your doctor.
Danish: Hvis du holder op med at tage Fareston Behandling med Fareston bør kun ophøre, hvis din læge har anbefalet det. Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: Other medicines and Fareston
Danish: Brug af anden medicin sammen med Fareston
English: Pregnancy and breast-feeding Do not use Fareston during pregnancy or breast feeding.
Danish: Graviditet og amning Du må ikke tage Fareston under graviditet eller amning.
English: What Fareston looks like and contents of the pack White, round, flat, bevelled edge tablet with TO 60 on one side.
Danish: Udseende og pakningsstørrelser Hvid, rund, flad tablet med skrå kanter og mærket TO 60 på den ene side.
English: - The other ingredients are maize starch, lactose monohydrate, povidone, sodium starch glycolate,
Danish: - Øvrige indholdsstoffer: majsstivelse, lactosemonohydrat, povidon, natriumstivelsesglycolat,
English: Skin and subcutaneous tissue disorders sweating rash, itching alopecia
Danish: Hud og subkutane væv svedtendens udslæt, kløe alopeci
English: Common (≥ 1/100 to <1/10)
Danish: Almindelig (>1/100 til 1/10)
English: The dose-related QTc interval prolongation potential of Fareston should also be taken into account in cases of overdose.
Danish: Ved en overdosis skal Farestons potentielle dosisrelaterede forlængelse af QTc-intervallet også tages i betragtning.
English: Vascular disorders hot flushes thromboembolic events
Danish: Vaskulære sygdomme hedestigninger tromboembolisk hændels er
English: Neoplasms beningn, malignant and unspecified (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 tablet contains: 60 mg toremifene (as citrate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 tablet indeholder: 60 mg toremifen (som citrat) LISTE OVER HJÆLPESTOFFER lactosemonohydrat
English: Reproductive system and uterine bleeding endometrial hypertrophy endometrial polyps endometrial hyperplasia,
Danish: Det reproduktive system og mammae uterinblødning, leukoré endomet riehyper -trofi endometri epolypper endometriehyperplasi
English: Toremifene has no influence on the ability to drive and use machines.
Danish: Fareston påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: It has similar anti-estrogenic, albeit weaker anti-tumour activity than the parent compound.
Danish: N-demethyltoremifen har lignende antiøstrogen, men svagere antitumor effekt end modersubstansen.
English: Uncommon (≥ 1/1,000 to < 1/100)
Danish: Ikke almindelig (>1/1.000 til 1/100)
English: - if you have a thickening of the womb lining - if you have severe liver problems - if you were born with or have had any condition which causes certain abnormal changes in the electrical recording of the heart (electrocardiogram or ECG) - if you have a salt imbalance in the blood, especially low concentrations of potassium in the blood
Danish: Tag ikke Fareston: - hvis du er allergisk over for toremifen eller et af de øvrige indholdsstoffer i Fareston (angivet i punkt 6) - hvis du har en fortykkelse af livmoderslimhinden - hvis du har alvorlige leverproblemer - hvis du er født med eller har oplevet tilfælde med visse unormale forandringer i hjertets elektriske aktivitet (ses i elektrokardiogram (ekg)) - hvis du har en forstyrrelse i blodets saltbalance, især lavt indhold af kalium i blodet
English: Fareston 60 mg tablets toremifene
Danish: Fareston 60 mg, tabletter toremifen
English: Therefore co-administration of Fareston with any of the following medicinal products is contraindicated (see also section 4.3): antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), certain antimicrobials agents (moxifloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), others (cisapride, vincamine IV, bepridil, diphemanil).
Danish: 4.3): - antiarytmika klasse IA (f.eks. quinidin, hydroquinidin, disopyramid) eller - antiarytmika klasse III (f.eks. amiodaron, sotalol, dofetilid, ibutilid) - neuroleptika (f.eks. phenothiaziner, pimocid, sertindol, haloperidol, sultoprid) - visse antimikrobielle lægemidler (moxifloxacin, erythromycin i.v., pentamidin, lægemidler mod malaria især halofantrin) - visse antihistaminer (terfenadin, astemizol, mizolastin) - andre (cisaprid, vincamin i.v., bepridil, diphemanil).
English: General disorders and administration site conditions fatigue oedema weight increase,
Danish: Almene symptomer og reaktioner på administrationsstedet træthed, ødemer vægtstig ning
English: How to take Fareston
Danish: Sådan skal du tage Fareston
English: Joensuunkatu 7
Danish: Orionintie 1
English: NAME OF THE MEDICINAL PRODUCT Fareston 60 mg tablets
Danish: LÆGEMIDLETS NAVN Fareston 60 mg tabletter
English: (see section 2 Do not take Fareston) - if you have any heart condition, including chest pain (angina) - if your cancer has spread to the bones (bone metastasis) as calcium blood levels may increase at the beginning of treatment with Fareston.
Danish: Din læge vil muligvis råde dig til at stoppe med at tage Fareston og få undersøgt, hvordan dit hjerte fungerer (ekg) (se punkt 2 ”Tag ikke Fareston”) - hvis du har nogen form for hjertelidelse herunder brystsmerter (angina) - hvis din kræft har spredt sig til knoglerne (knoglemetastaser), da calciumniveauet i dit blod kan stige i begyndelsen af behandlingen med Fareston.
English: What Fareston contains - The active substance is toremifene; each tablet contains 60 mg (as citrate).
Danish: - Aktivt stof: toremifen: Hver tablet indeholder 60 mg (som citrat).
English: Very rare side effects (may affect up to 1 in 10,000 people) - changes in the lining of the uterus (endometrium), cancer of the lining of the womb (endometrial cancer) - hair loss (alopecia) - cloudiness of the eye surface (transient corneal opacity) - yellowing of the skin or whites of the eyes (jaundice).
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 personer) - ændringer i livmoderslimhinden (endometriet) - kræft i livmoderslimhinden - hårtab - forbigående uklarhed i hornhinden - gulfarvning af huden og det hvide i øjnene (gulsot).
English: Hepatobiliary disorders increase of transaminases jaundice hepatitis, hepatic steatosis
Danish: Lever og galdeveje aminotran sferasestigning gulsot hepatitis, steatosis hepatis
English: There is a known interaction between anti-estrogens and warfarin-type anticoagulants leading to a seriously increased bleeding time.
Danish: Interaktion mellem antiøstrogener og antikoagulantia af warfarin-typen fører til stærkt forlænget blødningstid, hvorfor samtidig brug af toremifen og sådanne lægemidler bør undgås.
English: NAME OF THE MEDICINAL PRODUCT Fareston 60 mg tablets toremifene
Danish: LÆGEMIDLETS NAVN Fareston 60 mg tabletter toremifen
English: Uncommon side effects (may affect up to 1 in 100 people) - headache, sleep disorders - weight increase, constipation, loss of appetite - thickening of the lining of the womb (endometrial hypertrophy) - blood clot for example in the lung (thromboembolic events) - shortness of breath.
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer) - hovedpine, søvnproblemer - vægtstigning, forstoppelse, appetitløshed - fortykkelse af livmoderslimhinden - dannelse af blodpropper f.eks. i lungerne - kortåndethed.
English: Common side effects (may affect up to 1 in 10 people ) - fatigue, dizziness, depression - nausea (feeling sick), vomiting - rash, itching, oedema (swelling) - uterine bleeding, white discharge.
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer) - træthed, svimmelhed, depression - kvalme, opkastning - udslæt, kløe, væskeansamlinger (ødemer) - blødning fra livmoderen, hvidt udflåd.
English: Rare side effects (may affect up to 1 in 1,000 people) - a feeling of spinning (vertigo) - growth on the lining of the womb (endometrial polyps) - increase in liver enzymes (increase of liver transaminases).
Danish: Sjældne bivirkninger (kan påvirke op til 1 ud af 1.000 personer) - følelse af, at det snurrer rundt (svimmelhed) - udvoksninger på livmoderslimhinden (polypper i livmoderens slimhinde) - forhøjede leverenzymer i blodet (forhøjede aminotransferaser).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 60 mg toremifene (as citrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 60 mg toremifen (som citrat) Hjælpestof, som behandleren skal være opmærksom på: Én tablet indeholder 28,5 mg lactose Alle hjælpestoffer er anført under pkt.
English: What Fareston is and what it is used for What you need to know before you take Fareston How to take Fareston
Danish: Det skal du vide, før du begynder at tage Fareston Sådan skal du tage Fareston Bivirkninger
English: Peak concentrations in serum are obtained within 3 (range 2 - 5) hours.
Danish: 3 (variation 2-5) timer.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at de ikke tåler visse sukkerarter.
English: Fareston should not be used during lactation.
Danish: Det frarådes at anvende Fareston under amning.
English: tablet 30 tablets 100 tablets
Danish: 30 tabletter
English: Thrombocytopenia, anaemia and leukopenia
Danish: Blod og lymfesystem trombocyto peni, anæmi og leukopeni
English: Gastrointestinal disorders nausea, vomiting constipation
Danish: Mave-tarmkanalen kvalme, opkastning obstipati on
English: 6.6 Special precautions for disposal
Danish: 6.6 Regler for bortskaffelse Ingen særlige forholdsregler ved bortskaffelse.
English: - if you have unstable diabetes - if your general well-being is severely deteriorated - if you have previously had a condition in which blood clots formed in blood vessels, for example in your lungs (lung embolism) or in the veins of your legs (deep vein thrombosis).
Danish: Kontakt lægen eller apotekspersonalet, før du tager Fareston: - hvis du har ustabil diabetes (sukkersyge) - hvis dit helbred er alvorligt forringet - hvis du tidligere har haft en tilstand, hvor der dannes blodpropper i dine vener, f.eks. i lungerne
English: Eye disorders transient corneal opacity
Danish: Øjne forbigåend ekorneauklarhed
English: pentamidine and antimalarials (particularly halofantrine) - certain medicines to treat allergies; such as terfenadine, astemizole and mizolastine - others; cisapride, intravenous vincamine, bepridil, diphemanil.
Danish: amiodaron, sotalol, dofetilid og ibutilid - medicin til behandling af psykiske og adfærdsmæssige lidelser (antipsykotika) såsom phenothiaziner, pimozid, sertindol, haloperidol og sultoprid - lægemidler til behandling af infektioner (antibiotika) såsom moxifloxacin, erythromycin i en blodåre, pentamidin og lægemidler mod malaria (især halofantrin) - visse lægemidler til behandling af allergier såsom terfenadin, astemizol og mizolastin - andre; cisaprid, vincamin i en blodåre, bepridil, diphemanil.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Orion Corporation Orion Pharma
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen Orion Corporation
English: Vertigo, headache and dizziness were observed in healthy volunteer studies at daily dose of 680 mg.
Danish: Ved daglige doser på 680 mg er hos raske forsøgspersoner observeret vertigo, hovedpine og svimmelhed.
English: Contact your doctor, pharmacist or the nearest hospital immediately.
Danish: Kontakt straks lægen, skadestuen eller apoteket, hvis du har taget mere Fareston, end der står i denne information eller mere end lægen har foreskrevet.
English: Absorption
Danish: Opbevaring
English: How to store Fareston
Danish: frarådes det at anvende Fareston.
English: It is available as tablets (200 mg).
Danish: Det leveres som tabletter (200 mg).
English: It should not be used with combinations that are ‘modified release' (when the levodopa is released slowly over a few hours).
Danish: Det må ikke anvendes i kombinationer med modificeret frigivelse (når levodopa frigives langsomt i løbet af nogle få timer).
English: It is taken as one tablet with each dose of the other medicine, up to a maximum of 10 tablets a day.
Danish: Det tages som én tablet sammen med hver dosis af det andet lægemiddel, dog højst 10 tabletter dagligt.
English: The full EPAR for Entacapone Teva can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Entacapone Teva findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Entacapone Teva on 18 February 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Entacapone Teva den 18. februar 2011.
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
Danish: Fluktuationer forekommer, når lægemidlets virkning aftager, og symptomerne vender tilbage.
English: This is a summary of the European public assessment report (EPAR) for Entacapone Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Entacapone Teva.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Entacapone Teva.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Entacapone Teva skal anvendes.
English: For more information about treatment with Entacapone Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Entacapone Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
Danish: Det virker kun, når det tages sammen med levodopa, der er en kopi af neurotransmitteren dopamin, som kan tages gennem munden.
English: The CHMP concluded that, in accordance with EU requirements, Entacapone Teva has been shown to have comparable quality and to be bioequivalent to Comtess.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Entacapone Teva er af sammenlignelig kvalitet og er bioækvivalent med Comtess.
English: This means that Entacapone Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Comtess.
Danish: Det betyder, at Entacapone Teva er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union, og som hedder Comtess.
English: When patients first add Entacapone Teva to their existing medication, they may need to take a lower daily dose of levodopa, either by changing how often they take it, or by reducing the amount of levodopa taken in each dose.
Danish: Når patienterne begynder at tage Entacapone Teva i tillæg til de lægemidler, de tager i forvejen, skal de muligvis tage en lavere daglig dosis af levodopa, enten ved at tage lægemidlet i andre intervaller eller ved at reducere mængden af levodopa i den enkelte dosis.
English: Entacapone Teva is used to treat patients with Parkinson's disease.
Danish: Entacapone Teva anvendes til behandling af patienter med Parkinsons sygdom.
English: The active substance in Entacapone Teva, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Danish: Det aktive stof i Entacapone Teva, entakapon, genopretter indholdet af dopamin i de dele af hjernen, der styrer bevægelser og koordination.
English: Entacapone Teva entacapone
Danish: Entacapone Teva entakapon
English: Therefore, the CHMP's view was that, as for Comtess, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Comtess.
English: Entacapone Teva is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘fluctuations' towards the end of the period between two doses of their medication.
Danish: Entacapone Teva anvendes sammen med levodopa (en kombination enten af levodopa og benserazid eller af levodopa og carbidopa), når patienten får fluktuationer hen mod slutningen af perioden mellem to doser af lægemidlet.
English: Entacapone Teva is only used in combination either with levodopa and benserazide or with levodopa and carbidopa.
Danish: Entacapone Teva anvendes kun i kombination med enten levodopa og benserazid eller levodopa og carbidopa.
English: Entacapone Teva is a medicine that contains the active substance entacapone.
Danish: Entacapone Teva er et lægemiddel, der indeholder det aktive stof entakapon.
English: Entacapone Teva can only be used with conventional combinations of levodopa.
Danish: Entacapone Teva må kun anvendes med konventionelle kombinationer af levodopa.
English: Entacapone Teva is used when these fluctuations cannot be treated with the standard levodopa-containing combination alone.
Danish: Entacapone Teva benyttes, når disse fluktuationer ikke kan behandles alene ved hjælp af standardkombinationen indeholdende levodopa.
English: Other information about Entacapone Teva
Danish: Andre oplysninger om Entacapone Teva
English: They are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulties moving about.
Danish: Fluktuationer er forbundet med den aftagende virkning af levodopa, der for patienten medfører pludselige skift mellem ”on-perioder”, hvor patienten er i stand til at bevæge sig, og ”offperioder”, hvor patienten har vanskeligt ved at bevæge sig.
English: Entacapone Teva is a ‘generic medicine'.
Danish: Entacapone Teva er et "generisk lægemiddel".
English: Because Entacapone Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Entacapone Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Entacapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catechol-O-methyl transferase (COMT).
Danish: Entakapon blokerer et enzym kaldet catechol-O-methyltransferase (COMT), som medvirker ved nedbrydningen af levodopa i kroppen.
English: What are the benefits and risks of Entacapone Teva?
Danish: Hvilken fordel og risiko er der forbundet med Entacapone Teva?
English: Because Entacapone Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Comtess.
Danish: Da Entacapone Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Comtess.