FrancophonIA/ELRC3.0 huggingface dataset:
English: This improvement in objective measures (superficial and parabasal cells and pH) were sustained in ospemifene treated women in a long-term study of up to 52 weeks.
Danish: Denne forbedring i objektive målinger (overfladiske og parabasale celler og pH) blev fastholdt hos de ospemifen-behandlede kvinder i et længerevarende studie af op til 52 ugers varighed.
English: Ganciclovir used to treat infections caused by a virus called cytomegalovirus.
Danish: o Ganciclovir, som bruges til behandling af infektioner, som skyldes en virus, der kaldes cytomegalovirus.
English: This medicine is not recommended if you have severely reduced liver function.
Danish: Du bør ikke tage denne medicin, hvis du har alvorligt nedsat leverfunktion.
English: Your doctor may consider stopping treatment with Senshio while you are taking fluconazole.
Danish: Din læge kan overveje at stoppe behandlingen med Senshio, mens du tager fluconazol.
English: This binding results in activation of some oestrogenic pathways (agonism) and blockade of other oestrogenic pathways (antagonism).
Danish: Denne binding resulterer i aktivering af nogle østrogene pathways (agonisme) og blokering af andre østrogene pathways (antagonisme).
English: Adverse reactions are listed below by MedDRA preferred term system organ class and by frequency.
Danish: Bivirkningerne er angivet nedenfor i henhold til MedDRAs foretrukne udtryk for systemorganklasse og hyppighed.
English: Your doctor may recommend that you stop treatment at least 4 to 6 weeks prior to major surgery or during a long period of bed rest e.g. injury or illness.
Danish: Din læge vil muligvis anbefale dig at standse din behandling i mindst 4 til 6 uger før en større operation eller ved længere tids sengeligning som følge af en skade eller sygdom.
English: Percentage of patients with improvement, relief or substantial improvement of MBS after 12 weeks on ospemifene vs. placebo (ITT, LOCF)
Danish: Procentdel af patienter med forbedring, lindring eller væsentlig forbedring af MBS efter 12 uger på ospemifen vs. placebo (ITT, LOCF)
English: Due to its lipophilic nature and absorption characteristics, an interaction between ospemifene and medicinal products like orlistat, cannot be ruled out.
Danish: Grundet dets lipofile natur og absorptionskarakteristika kan en interaktion mellem ospemifen og lægemidler som orlistat ikke udelukkes.
English: Plasma/blood cell partitioning of [14C]-Ospemifene (< 3%) and [14C]-4-hydroxyospemifene (< 2%) is low.
Danish: Plasma/blodlegemedeling af [14C]-Ospemifen (< 3%) og [14C]-4-hydroxyospemifen (<2%) er lav.
English: It is caused by a lowering in the levels of the female hormone oestrogen in your body.
Danish: Det skyldes det faldende niveau af det kvindelige kønshormon østrogen i din krop.
English: A clinical monitoring of a decrease in the efficacy of ospemifene should be made.
Danish: Der skal iværksættes klinisk monitorering af en eventuel reduktion i ospemifens virkning.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk -forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The PL is updated in accordance.
Danish: Indlægssedlen opdateres i overensstemmelse hermed.
English: - You have an autoimmune condition called systemic lupus erythematosus (SLE).
Danish: - Du har en sygdom i immunsystemet, der kaldes systemisk lupus erythematosus (SLE).
English: Co-administration with fluconazole
Danish: Administration samtidig med fluconazol
English: In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually taking into consideration other menopausal symptoms, effects on uterine and breast tissues, thromboembolic and cerebrovascular risks.
Danish: Der skal i alle tilfælde foretages en grundig vurdering af risici og fordele mindst en gang årligt, hvor andre menopausale symptomer, virkninger på uterus- og brystvæv, tromboemboliske og cerebrovaskulære risici skal tages med i betragtning.
English: Unexplained vaginal bleeding.
Danish: Uforklarlig vaginal blødning.
English: Ospemifene belongs to a group of medicines that do not contain hormones called Selective Estrogen Receptor Modulators (SERMs).
Danish: Ospemifen tilhører en gruppe lægemidler, som ikke indeholder hormoner, og som kaldes selektive østrogen-receptor-modulatorer (SERM'er).
English: Therefore, ospemifene may increase concentrations of medicinal products which are substrates of OCT1 (e.g. metformin, acyclovir, ganciclovir and oxaliplatin).
Danish: Ospemifen kan derfor øge koncentrationen af lægemidler, som er substrater for OCT1 (f.eks. metformin, acyclovir, ganciclovir og oxaliplatin).
English: Improvement
Danish: Forbedring
English: You will not benefit from the effects of Senshio if you stop using it without talking to your doctor.
Danish: Du vil ikke drage fordel af virkningen af Senshio, hvis du holder op med at tage det uden først at have talt med din læge.
English: Shionogi B.V. Tel/Tel./Te./Tlf/Tél/Puh/Sími/ :
Danish: Tel/Tel./Teл./Tlf/Tél/Puh/Sími/Τηλ:
English: Therefore ospemifene should be used for the treatment of VVA only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Danish: Derfor må ospemifen kun bruges til behandling af VVA, efter at behandlingen af brystcancer, herunder adjuverende behandling, er afsluttet.
English: A trend was observed in both trials in the improvement of MBS from baseline to week 4 in favour of ospemifene compared to placebo, although the difference was not statistically significant.
Danish: Der blev observeret en tendens i begge studier i forbedringen af MBS fra baseline til uge 4 til fordel for ospemifen sammenlignet med placebo, selvom forskellen ikke var statistisk signifikant.
English: Effects of ospemifene on other medicinal products
Danish: Ospemifens indvirkning på andre lægemidler
English: Breast cancer
Danish: Brystcancer
English: Taking into account the PRAC Assessment Report on the PSUR(s) for ospemifene, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for ospemifen er CHMP nået frem til følgende videnskabelige konklusioner:
English: The apparent terminal half-life of ospemifene in post-menopausal women is approximately 25 hours.
Danish: Den tilsyneladende terminale halveringstid for ospemifen er ca. 25 timer hos postmenopausale kvinder.
English: Ospemifene has been administered to subjects in single doses for up to 800 mg day and repeat doses up to 240 mg/day for 7 days and up to 200 mg/day for 12 weeks.
Danish: Ospemifen er blevet administreret til forsøgspersoner i enkeltdoser på op til 800 mg/dag og gentagne doser på op til 240 mg/dag i 7 dage og op til 200 mg/dag i 12 uger.
English: Ospemifene is primarily metabolised by the liver.
Danish: Ospemifen metaboliseres hovedsageligt af leveren.
English: It is unknown if ospemifene is a substrate for BCRP in the intestine.
Danish: Det vides ikke, om ospemifen er et substrat for BCRP i tarmen.
English: EU/1/14/978/001 7 film-coated tablets EU/1/14/978/002 28 film-coated tablets EU/1/14/978/003 84 film-coated tablets
Danish: EU/1/14/978/001 7 filmovertrukne tabletter EU/1/14/978/002 28 filmovertrukne tabletter EU/1/14/978/003 84 filmovertrukne tabletter
English: The mean age of participants was 61.7 years in the ospemifene 60 mg group and 62.9 years in the placebo group.
Danish: Deltagernes gennemsnitsalder var 61,7 år i ospemifen 60 mg-gruppen og 62,9 år i placebogruppen.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, selective estrogen receptor modulators, ATC code: G03XC05.
Danish: Farmakoterapeutisk klassifikation: Kønshormoner og modulatorer af genitalsystemet, selektiv østrogenreceptormodulator, ATC-kode: G03XC05.
English: There are no data on the use of ospemifene in pregnant women.
Danish: Der er ingen data fra anvendelse af ospemifen til gravide kvinder.
English: Renal clearance of unchanged active substance is a minor pathway of elimination, less than 0.2% of the ospemifene dose is excreted unchanged in urine.
Danish: Nyreclearance af uændret aktivt stof er en mindre eliminationsvej, mindre end 0,2% af ospemifendosen udskilles uændret i urin.
English: This is because there are no data on the use of Senshio in pregnant or pre-menopausal women or those who are breast-feeding.
Danish: Det skyldes, at der ikke findes data for anvendelse af Senshio til gravide eller præmenopausale kvinder eller kvinder, som ammer.
English: Generally recognised risk factors for VTE include advanced age, a family history, severe obesity (BMI>30 kg/m2) and systemic lupus erythematosus (SLE).
Danish: Almindeligt anerkendte risikofaktorer for VTE inkluderer højere alder, familiær disposition, svær adipositas (BMI >30 kg/m2) og systemisk lupus erythematosus (SLE).
English: Pharmacokinetic differences due to race have been studied in 1,091 postmenopausal women, including 93.1% White, 3.9% Black, 1.8% Asian and 1.1% other in VVA trials.
Danish: Farmakokinetiske forskelle, som skyldes race, blev undersøgt hos 1.091 postmenopausale kvinder, herunder 93,1% hvide, 3,9% sorte, 1,8% asiatiske og 1,1% andre i VVA-studier.
English: Patients with suspected breast cancer or patients undergoing active treatment (including adjuvant therapy) for breast cancer (see section 4.4).
Danish: Ved mistanke om brystcancer eller hos patienter, som er i aktiv behandling (herunder adjuverende behandling) for brystcancer (se pkt.
English: Manufacturing Packaging Farmaca (MPF) B.V. Appelhof 13
Danish: Manufacturing Packaging Farmaca (MPF) B.V.
English: In post-menopausal women who received ospemifene treatment up to 1 year, benign endometrial polyps were reported in 0.4% compared to 0.2% in women who received placebo treatment.
Danish: Der blev hos postmenopausale kvinder, som modtog ospemifen-behandling i op til 1 år, rapporteret benigne endometriepolypper hos 0,4% sammenlignet med 0,2% hos de kvinder, som modtog placebo-behandling.
English: The most frequently reported adverse reactions are hot flushes (7.5%).
Danish: Sammendrag af sikkerhedsprofilen Den hyppigst rapporterede bivirkning er hedestigninger (7,5 %).
English: - If your doctor thinks you might have breast cancer or you are being treated for breast cancer.
Danish: - Hvis din læge mener, at du kunne have brystkræft, eller du er i behandling for brystkræft.
English: Ospemifene may increase the incidence of hot flushes and is not effective in reducing hot flushes associated with oestrogen deficiency.
Danish: Ospemifen kan øge hyppigheden af hedestigninger og er ikke effektivt til reduktion af hedestigninger, som er forbundet med østrogenmangel.
English: In the F0 maternal generation, a significant prolonged gestation was observed.
Danish: Der blev i F0-generationen for mødrene observeret en betydelig forlænget drægtighedsperiode.
English: Patients should be advised to contact their doctors immediately when they experience a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
Danish: Patienten skal opfordre til straks at kontakte sin læge, hvis vedkommende bliver opmærksom på eventuelle tromboemboliske symptomer (f.eks. smertefuld hævelse af ben, pludselige smerter i brystet, dyspnø).
English: “Substantial improvement” was restricted to patients who had moderate or severe MBS at baseline and changed from severe to mild or severe or moderate to none.
Danish: "Væsentlig forbedring" gjaldt kun de patienter, som havde et moderat til svært MBS ved baseline, og hvor det ændrede sig fra svært til mildt eller fra moderat til intet.
English: Package leaflet: Information for the patient Senshio 60 mg film-coated tablets ospemifene This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Senshio 60 mg filmovertrukne tabletter ospemifen Dette lægemiddel er underlagt supplerende overvågning.
English: - If your doctor thinks you might have or you are being treated for cancer which is sensitive to oestrogens, such as cancer of the womb.
Danish: - Hvis din læge mener, at du kunne have, eller du er i behandling for kræft, som er følsom over for østrogener, som f.eks. livmoderkræft.
English: Fluconazole (an oral medicine used to treat fungal infections) as this may increase the amount of ospemifene in your blood.
Danish: • Fluconazol (en medicin, som tages gennem munden, og som bruges til behandling af svampeinfektion), da dette kan øge mængden af ospemifen i dit blod.
English: There is therefore no reason to expect that strong CYP3A4 inhibitors would cause a clinically meaningful change in ospemifene exposure.
Danish: Der er derfor ikke grund til at forvente, at stærke CYP3A4-hæmmere vil forårsage en klinisk betydningsfuld ændring i eksponeringen af ospemifen.
English: No changes in blood biochemical parameters such as ALT or ALP were determined in postmenopausal women treated with Ospemifene in clinical studies.
Danish: Der blev ikke påvist ændringer i blod-biokemiske parametre, som f.eks. ALAT eller ALP, hos postmenopausale kvinder behandlet med ospemifen i kliniske studier.
English: Each film-coated tablet contains 60 mg ospemifene.
Danish: Hver filmovertrukket tablet indeholder 60 mg ospemifen.
English: - Any of your close relatives has ever had a blood clot in the leg, lung or other organ.
Danish: - Et nært familiemedlem har haft en blodprop i benet, lungerne eller andet organ.
English: In contrast, abnormal, not clinically significant, findings on mammography increased in the placebo population from 6.5% to 8.3%.
Danish: I modsætning hertil steg forekomsten af afvigende, ikke klinisk signifikante resultater ved mammografi i placebopopulationen fra 6,5% til 8,5%.
English: Therefore, caution is recommended when ospemifene is combined with orlistat.
Danish: Der tilrådes derfor forsigtighed, når ospemifen gives i kombination med orlistat.
English: - If you have or have ever had a blood clot in a vein (thrombosis), for example, in your legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal thrombosis).
Danish: - Hvis du har eller nogensinde har haft en blodprop i en vene (trombose), f.eks. i dine ben (dyb venetrombose), lunger (lungeemboli) eller øjne (retinal trombose).
English: Talk to your doctor or pharmacist before taking Senshio if any of the following apply to you.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Senshio, hvis et eller flere af nedenstående punkter gælder dig.
English: In the two 12 weeks studies (trials 1 and 2), 739 patients received ospemifene and 724 patients received placebo.
Danish: I de to studier af 12 ugers varighed (studie 1 og 2) modtog 739 patienter ospemifen, og 724 patienter modtog placebo.
English: Overall, these findings are characteristic for an induction of CYP isoenzymes and are regarded as adaptive responses without any histopathological signs of liver injury.
Danish: Disse fund er i sig selv karakteristiske for en induktion af CYP-isoenzymer og betragtes som adaptive responser uden histopatologiske tegn på leverskade.
English: No subjects in either group developed endometrial cancer or breast cancer during the trials.
Danish: Ingen af forsøgspersonerne i de to grupper udviklede endometriecancer eller brystcancer under studierne.
English: Aciclovir used to treat cold sores and genital herpes.
Danish: o Aciclovir, som bruges til behandling af forkølelsessår og herpes på kønsdelene.
English: Ospemifene and 4-hydroxyospemifene are highly (both >99%) bound to serum proteins.
Danish: Ospemifen og 4-hydroxyospemifen er stærkt (begge >99 %) bundet til serumproteiner.
English: Any of the following medicines, as their concentrations may be increased while taking Senshio: Metformin used to treat Type II diabetes.
Danish: • Nogen af følgende lægemidler, da koncentrationen af disse kan øges, når du tager Senshio: o Metformin, som bruges til behandling af type II-diabetes.
English: When this happens, the vaginal walls can become thinner.
Danish: Når dette sker, bliver slimhinden i skeden tyndere.
English: Ospemifene was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests.
Danish: Ospemifen var ikke mutagen eller clastogen ved evaluering i et standardbatteri bestående af in vitro og in vivo tests.
English: - If you are allergic to ospemifene or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for ospemifen eller et af de øvrige indholdsstoffer i Senshio (angivet i afsnit 6).
English: No data are available on its concomitant use with medicinal products used in the treatment of early or advanced breast cancer.
Danish: Der er ingen tilgængelige data om den samtidige behandling med lægemidler, der bruges på et tidligt stadie af eller ved fremskreden brystcancer.
English: The principal radioactive component in both plasma and faeces was ospemifene and the main metabolite 4hydroxyospemifene.
Danish: Den væsentligste radioaktive komponent i både plasma og fæces var ospemifen og hovedmetabolitten 4-hydroxyospemifen.
English: The reproductive effects observed are considered to be related to oestrogen receptor activity of ospemifene.
Danish: De observerede reproduktive virkninger betragtes som værende forbundet til ospemifens østrogenreceptoraktivitet.
English: The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective estrogen receptor modulators (SERMs).
Danish: Risikoen for VTE (dyb venetrombose og lungeemboli) er øget for andre selektive østrogenreceptormodulatorer (SERM'er).
English: The absolute bioavailability of ospemifene has not been established.
Danish: Den absolutte biotilgængelighed af ospemifen er ikke påvist.
English: Any of the following medicines, which may lead to a reduced effect of Senshio: Rifampicin and rifabutin commonly used to treat tuberculosis.
Danish: • Nogen af følgende lægemidler, da de kan medføre nedsat virkning af Senshio: o Rifampicin og rifabutin, som almindeligvis bruges til behandling af tuberkulose.
English: If you forget to take a tablet you should take the missed tablet (with food) as soon as you remember within the same day.
Danish: Hvis du har glemt at tage en tablet, skal du tage den glemte tablet (i forbindelse med et måltid), så snart du husker det samme dag.
English: There is no relevant use of ospemifene in the paediatric population for the indication of the treatment of moderate to severe symptomatic VVA in post-menopausal women.
Danish: Det er ikke relevant at anvende ospemifen hos den pædiatriske population til indikationen behandling af moderat til svær symptomatisk VVA hos postmenopausale kvinder.
English: Substantial improvement 60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo
Danish: Væsentlig forbedring 60 mg OSP Placebo 60 mg OSP Placebo 60 mg OSP Placebo
English: The incidence of endometrial hyperplasia was 0.3% (1 case out of 317 biopsies) after 1 year of treatment with an upper 95% confidence limit of 1.74% (see section 5.1).
Danish: Incidensen af hyperplasi af endometriet var 0,3% (1 tilfælde ud af 317 biopsier) efter 1 års behandling med en øvre 95%-konfidensgrænse på 1,74% (se pkt.
English: - If you experience signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, difficulty in breathing or a stroke while taking Senshio, stop taking Senshio and see a doctor immediately.
Danish: - Hvis du får tegn på en blodprop, som f.eks. smertefuld hævelse og rødme i benet, pludselige smerter i brystet, vejtrækningsbesvær eller et slagtilfælde, mens du tager Senshio, skal du straks holde op med at tage Senshio og kontakte en læge.
English: The risk of cerebrovascular events is possibly increased with other SERMs.
Danish: Der kan være øget risiko for cerebrovaskulære hændelser med andre SERM'er.
English: Ospemifene did not cause a clinically meaningful change in the exposure to the substrates, indicating that ospemifene does not affect those enzyme activities in vivo to a clinically significant extent.
Danish: Ospemifen forårsagede ikke en klinisk betydningsfuld ændring i eksponeringen for substraterne, hvilket indikerer, at ospemifen ikke påvirker disse enzymaktiviteter in vivo i klinisk signifikant grad.
English: Treatment should be resumed only after the patient is mobilised.
Danish: Behandlingen må først genoptages, når patienten igen er mobil.
English: In repeat dose toxicity studies in mouse, rat, dog and the cynomolgus monkey main target organs of toxicity were the ovary, uterus and the liver.
Danish: I toksicitetsstudier efter gentagne doser, som blev udført på mus, rotter, hunde og cynomolgus-aber, var de primære målorganer for toksicitet ovarier, uterus og leveren.
English: This difference is not considered clinically relevant and no dose adjustment is necessary in patients with renal impairment.
Danish: Denne forskel betragtes ikke som værende klinisk relevant, og dosisjustering er derfor ikke nødvendig hos patienter med nyreinsufficiens.
English: Taken together, the liver changes observed in experimental animals in repeat dose toxicity studies are regarded as adaptive changes due to enzyme induction and given the lack of any clinical signs are unlikely to represent a safety concern for humans.
Danish: Sammenholdt betragtes de leverændringer, som blev observeret hos forsøgsdyr i toksicitetsstudier efter gentagne doeser, som adaptive ændringer, som skyldtes enzyminduktion, og som følge af mangel på kliniske tegn er det usandsynligt, at de udgør et sikkerhedsproblem for mennesker.
English: If bleeding or spotting occurs on therapy, or continues after treatment has been discontinued, this should always be investigated, which may include an endometrial biopsy to exclude endometrial malignancy.
Danish: Hvis der forekommer blødning eller pletblødning under behandlingen, eller de fortsætter efter behandlingsseponering, skal der altid iværksættes undersøgelser, hvilket kan inkludere en endometriebiopsi, for at udelukke maligne sygdomme i endometriet.
English: The glycogen content of vaginal epithelial cells also decreases, resulting in reduced colonisation by lactobacilli and increased vaginal pH.
Danish: Glycogenindholdet i de vaginale epitelceller reduceres ligeledes, hvilket resulterer i reduceret kolonisering af lactobacilli og en stigning i vaginalt pH.
English: In patients with moderate hepatic impairment the exposure of ospemifene and 4-hydroxyospemifene was approximately 30% and 70% higher.
Danish: Hos patienter med moderat leverinsufficiens var eksponeringen for ospemifen og 4-hydroxyospemifen ca. 30% og 70% højere.
English: This is known as vulvar and vaginal atrophy.
Danish: Dette kaldes atrofi af vulva og vagina.
English: When ospemifene is administered with a high fat meal, the Cmax and AUC are 2.5-fold and 1.9-fold higher, respectively, with lower variability relative to the fasting state.
Danish: Når ospemifen administreres i forbindelse med et måltid med højt fedtindhold, er Cmax og AUC hhv. 2,5 gange og 1,9 gange højere, med lavere variabilitet i forhold til under fastende forhold.
English: Orlistat sometimes used to treat obesity.
Danish: o Orlistat, som somme tider bruges til behandling af overvægt.
English: Therefore, co-administration of ospemifene with strong enzyme inducers like carbamazepine, phenytoin, St John's wort and rifabutin would be expected to decrease the exposure of ospemifene, which may decrease the clinical effect.
Danish: Det kan derfor forventes, at samtidig administration af ospemifen og stærke enzyminduktorer, som carbamazepin, phenytoin, St Johns wort og rifabutin, vil reducere eksponeringen for ospemifen, hvilket kan reducere den kliniske virkning.
English: No clinically meaningful differences in ospemifene pharmacokinetics have been observed over the age range studied (40-80) years of age.
Danish: Der blev ikke observeret nogen betydningsfuld forskel ved ospemifens farmakokinetik i den undersøgte aldersgruppe (40-80 år).