FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilisation occurs.
Danish: Seponering bør ske hurtigst muligt i tilfælde af sygdom eller fra 3 dage før immobilisering vil finde sted.
English: The expiry date refers to the last day of the month.
Danish: Udløbsdatoen er den sidste dag i den nævnte måned.
English: Presystemic glucuronidation is extensive.
Danish: Præsystemisk glukuronidering er omfattende.
English: In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg.
Danish: I ulykkestilfælde med overdosering hos børn under 2 år har den maksimale rapporterede dosis været 180 mg.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: The Cmax of digoxin increased by less than 5 %.
Danish: Cmax af digoxin øges med mindre end 5 %.
English: Like all medicines, this medicine can cause side effects although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: A similar increase in BMD was seen in the treatment population who received Optruma for up to 7 years.
Danish: En tilsvarende øgning af BMD blev observeret i studiepopulationen, der modtog Optruma i op til 7 år.
English: de la Industria 30, 28108 Alcobendas (Madrid), Spain.
Danish: de la Industria 30, 28108 Alcobendas (Madrid), Spanien.
English: iv) Histomorphometry (bone quality).
Danish: iv) Histomorfometri (knoglekvalitet).
English: Renal insufficiency - Less than 6 % of the total dose is eliminated in urine.
Danish: Nyreinsufficiens - Mindre end 6% af den totale dosis elimineres i urinen.
English: This must be investigated by your doctor.
Danish: Dette skal undersøges af Deres læge.
English: Absolute bioavailability of raloxifene is 2 %.
Danish: Absolut biotilgængelighed af raloxifen er 2%.
English: The dose is one tablet a day.
Danish: Doseringen er én tablet daglig.
English: Women with the highest baseline cholesterol levels had the greatest decreases.
Danish: De kvinder, som havde de højeste baseline kolesterolkoncentrationer, oplevede også de største reduktioner.
English: There is no evidence of endometrial proliferation.
Danish: Der foreligger intet bevis for endometrieproliferation.
English: Mechanism of action and Pharmacodynamic effect
Danish: Virkningsmekanisme og farmakodynamisk virkning
English: In the RUTH study overall clinical fractures were collected as a secondary endpoint.
Danish: I RUTH-studiet blev de samlede kliniske frakturer indsamlet som et sekundært endpoint.
English: iii) Calcium kinetics.
Danish: iii) Calcium-kinetik.
English: No other metabolites have been detected.
Danish: Andre metabolitter er ikke identificeret.
English: This increase was generally a 2 % increase in BMD compared to placebo.
Danish: Denne øgning var sædvanligvis en 2 % øgning af BMD i forhold til placebo.
English: The majority of side effects seen with Optruma have been mild.
Danish: Størstedelen af de bivirkninger, som er set med Optruma, har været lette.
English: • If you have liver disease
Danish: • hvis De har en leversygdom
English: • Headache including migraine
Danish: • Hovedpine herunder migræne
English: You should have this investigated by your doctor.
Danish: De bør have dette undersøgt af Deres læge.
English: These results may have been confounded by baseline differences in BMD and vertebral fractures.
Danish: Disse resultater kan være blevet forstyrret af baselineforskelle i BMD og vertebrale frakturer.
English: After 3 years therapy Optruma decreased fibrinogen (6.71 %).
Danish: Efter 3 års behandling reducerede Optruma fibrinogen (6,71 %).
English: i) Incidence of fractures.
Danish: i) Forekomst af frakturer.
English: Raloxifene was not genotoxic in any of the extensive battery of test systems applied.
Danish: Raloxifen var ikke genotoksisk i nogen af de omfattende testsystemer, som blev benyttet.
English: In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
Danish: I nogle kliniske studier blev der givet daglige doser op til 600 mg i 8 uger og 120 mg i 3 år.
English: Forty five women with osteoporosis or 15 women with osteoporosis with an existing fracture would need to be treated with Optruma for 3 years to prevent one or more vertebral fractures.
Danish: Det vil være nødvendigt at behandle 45 kvinder med osteoporose eller 15 kvinder med osteoporose med en eksisterende fraktur med Optruma i 3 år for at afværge en eller flere frakturer.
English: The volume of distribution is not dose dependent.
Danish: Fordelingsvolumenet er ikke dosisafhængigt.
English: In the osteoporosis treatment trial, endometrial thickness was evaluated annually in a subset of the study population (1,644 patients) for 4 years.
Danish: I osteoporosebehandlingsundersøgelsen blev endometrietykkelsen evalueret årligt i 4 år i en undergruppe af undersøgelsespopulationen (1.644 patienter).
English: Optruma belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs).
Danish: Optruma tilhører en gruppe af ikke-hormonale lægemidler, som kaldes selektive østrogen-receptor modulatorer (SERM).
English: If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.
Danish: Hvis De tager digitalispræparater på grund af Deres hjerte eller antikoagulantia for at fortynde Deres blod (f.eks. warfarin), er Deres læge måske nødt til at justere Deres dosis af denne medicin.
English: The safety of Optruma in patients with breast cancer has not been adequately studied.
Danish: Sikkerheden af Optruma hos patienter med brystcancer er ikke tilstrækkeligt undersøgt.
English: Optruma may affect the development of the baby.
Danish: Optruma kan påvirke barnets udvikling.
English: • If you have had a cerebrovascular accident (e.g. stroke), or if your doctor has told you that you are at high risk of having one.
Danish: • Optrumahvis De har haft et slagtilfælde, eller hvis Deres læge har fortalt Dem, at De har høj risiko for at få et.
English: The doctor may also advise you to take calcium and vitamin D supplements.
Danish: Deres læge vil måske også råde Dem til at tage kalk- eller vitamin D-tilskud.
English: From the 4th to the 8th year, patients were permitted the concomitant use of bisphosphonates, calcitonin and fluorides and all patients in this study received calcium and vitamin D supplementation.
Danish: Fra det 4. års til det 8. års behandling måtte patienterne samtidig bruge bisphosphonater, calcitonin og fluorid, og alle patienter i denne undersøgelse fik calcium- og D-vitamintilskud.
English: Raloxifene does not affect the steady-state AUC of digoxin.
Danish: Raloxifen påvirker ikke steady state AUC af digoxin.
English: You should talk to your doctor first.
Danish: De skal først tale med Deres læge om det.
English: However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking Optruma.
Danish: Hvis De imidlertid tidligere har taget østrogen, og De har haft voldsomme stigninger i blodets triglycerider, bør De tale med Deres læge, før De tager Optruma.
English: Do not take Optruma if you are breast-feeding as it might be excreted in mother's milk.
Danish: Anvend ikke Optruma hvis De ammer, da det muligvis udskilles i modermælk.
English: No adverse effects on cognitive function have been seen.
Danish: Der er ikke set uønskede virkninger på den kognitive funktion.
English: ii) Bone Mineral Density (BMD): The efficacy of Optruma once daily in postmenopausal women aged up to 60 years and with or without a uterus was established over a two-year treatment period.
Danish: ii) Knoglemineraltæthed (BMD): Effekten af Optruma én gang daglig blev hos postmenopausale kvinder med eller uden uterus, og som var op til 60 år gamle, fastlagt over en toårig behandlings periode.
English: Approximately 60 % of an oral dose is absorbed.
Danish: Ca. 60% af en peroral dosis absorberes.
English: Eli Lilly and Company (Ireland) Limited Tel:
Danish: Eli Lilly and Company (Ireland) Limited.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige tilstande såsom galactoseintolerans, Lapp-laktase-mangel eller glucose-galactose-malabsorption bør ikke tage dette lægemiddel.
English: The majority of adverse reactions have not usually required cessation of therapy.
Danish: Størstedelen af bivirkningerne nødvendiggjorde sædvanligvis ikke ophør af behandlingen.
English: It is unknown whether raloxifene/raloxifene metabolites are excreted in human milk.
Danish: Det ukendt, om raloxifen/raloxifenmetabolitter udskilles i human mælk.
English: Do not take a double dose to make up for a forgotten tablet dose.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte.
English: e) Effects on cognitive function
Danish: e) Effekt på kognitiv funktion
English: The reproductive and developmental effects observed in animals are consistent with the known pharmacological profile of raloxifene.
Danish: Effekten på forplantning og udvikling hos dyr er i overensstemmelse med den kendte farmakologiske profil af raloxifen.
English: Nearly 3,000 transvaginal ultrasound (TVUs) examinations were evaluated from 831 women in all dose groups.
Danish: Omtrent 3.000 transvaginale ultralydsundersøgelser (TVU) fra 831 kvinder i alle dosisgrupper blev vurderet.
English: Avda de la Industria 30 28108 Alcobendas Madrid
Danish: de la Industria 30 28108 Alcobendas Madrid
English: HDL cholesterol and triglyceride concentrations did not change significantly.
Danish: Koncentrationerne af HDL kolesterol og triglycerid ændredes ikke signifikant.
English: Elderly: No dose adjustment is necessary for the elderly.
Danish: Dosisjustering er ikke nødvendig hos ældre.
English: Cholecystectomy rates for raloxifene (2.3 %) were not statistically significantly different from placebo (2.0 %).
Danish: Hyppigheden af kolecystektomi for raloxifen (2,3%) var ikke statistisk signifikant forskellig fra placebo (2,0%).
English: No data are available on the concomitant use of Optruma and agents used in the treatment of early or advanced breast cancer.
Danish: Der findes ikke tilgængelige data omkring samtidig brug af Optruma og midler brugt i behandlingen af tidlig eller avanceret brystcancer.
English: Effects on prothrombin time may develop over several weeks if Optruma treatment is started in patients who are already on coumarin anticoagulant therapy.
Danish: Virkninger på protrombintiden kan udvikles over flere uger, hvis Optruma-behandling påbegyndes hos patienter, som allerede er i antikoagulans-behandling med coumarin.
English: This binding results in differential expression of multiple oestrogen-regulated genes in different tissues.
Danish: Denne binding resulterer i differentieret ekspression af flere østrogen-regulerede gener i forskelligt væv.
English: The increase correlated with total bilirubin concentrations.
Danish: Denne stigning korrelerede med totale bilirubinkoncentrationer.
English: Generally calcium and vitamin D supplements are advised in women with a low dietary intake.
Danish: Calcium- og D-vitamintilskud anbefales generelt til kvinder med lav calciumindtagelse via føden.
English: If this medicinal product is used mistakenly during pregnancy or the patient becomes pregnant while taking it, the patient should be informed of the potential hazard to the foetus (see section 5.3).
Danish: Hvis præparatet fejlagtigt anvendes under graviditet, eller hvis patienten bliver gravid under behandling med præparatet, skal patienten informeres om den mulige risiko for fosteret (se pkt.
English: Optruma tablets are packed either in PVC/PE/PCTFE blisters or in high density polyethylene bottles.
Danish: Optruma tabletter pakkes i PVC/PE/PCTFE blisterkort eller i tabletglas af high density polyethylen.
English: Endometrial biopsies taken after six months therapy with Optruma 60 mg daily demonstrated nonproliferative endometrium in all patients.
Danish: Endometriebiopsier, som blev taget efter seks måneders behandling med Optruma 60 mg/dag, viste non-proliferative endometrier hos alle patienter.
English: The table below gives the adverse reactions and frequencies observed in treatment and prevention studies involving over 13,000 postmenopausal women along with adverse reactions arising from postmarketing reports.
Danish: Tabellen nedenfor angiver bivirkninger og frekvenser observeret i behandlings- og forebyggelsesstudier med over 13.000 postmenopausale kvinder sammen med bivirkninger fra postmarketing-rapporter.
English: The risk of a thromboembolic event was greatest in the first four months of therapy.
Danish: Risikoen for et tromboembolisk tilfælde var størst i de første fire måneder af behandlingen.
English: If you stop taking Optruma
Danish: Hvis De holder op med at tage Optruma
English: Optruma therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Danish: Optruma-behandling i 8 år havde ingen signifikant effekt på risikoen for kardiovaskulære hændelser hos patienter, der medvirkede i osteoporosebehandlings studiet.
English: b) Effects on lipid metabolism and cardiovascular risk
Danish: b) Effekt på lipidmetabolisme og kardiovaskulær risiko
English: So any vaginal bleeding while you take Optruma is unexpected.
Danish: Enhver form for blødning fra underlivet, mens De tager Optruma, er derfor uventet.
English: Increasing doses of raloxifene result in slightly less than proportional increase in the area under the plasma time concentration curve (AUC).
Danish: Stigende doser af raloxifen medfører en lidt mindre end proportional øgning af arealet under plasma-tid-koncentrationskurven (AUC).
English: Do not use after the expiry date which is stated on the pack after EXP.
Danish: Brug ikke Optruma efter den udløbsdato, der står på pakningen.
English: Optruma should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation.
Danish: Optruma bør seponeres i tilfælde af sygdom eller omstændigheder, som vil medføre en længere periode med immobilisering.
English: Pharmacotherapeutic group: Selective Oestrogen Receptor Modulator, ATC code: G03XC01.
Danish: Farmakoterapeutisk klassifikation: Selektiv østrogen-receptor modulator, ATC-kode: G03XC01
English: • If you have severe kidney problems.
Danish: • hvis De har svære problemer med nyrerne.
English: Clinical trials showed that a 60 mg daily dose of Optruma significantly decreased total cholesterol (3 to 6 %), and LDL cholesterol (4 to 10 %).
Danish: Kliniske studier har vist, at en daglig dosis af Optruma på 60 mg signifikant nedsatte total kolesterol (3-6 %) og LDL kolesterol (4-10 %).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Raloxifene is a potent antioestrogen in the rat uterus and prevented growth of oestrogen-dependent mammary tumours in rats and mice.
Danish: Raloxifen er et potent antiøstrogen i rotteuterus og forhindrede vækst af østrogen-afhængige mammatumorer hos rotter og mus.
English: Data suggests that the oestrogen receptor can regulate gene expression by at least two distinct pathways which are ligand-, tissue-, and/or genespecific.
Danish: Data tyder på, at østrogen-receptoren kan regulere ekspression af gener via mindst to forskellige mekanismer, som er ligand-, vævs- og/eller genspecifikke.
English: Optruma should not be used in patients with signs or symptoms of endometrial cancer as safety in this patient group has not been adequately studied.
Danish: Optruma bør ikke anvendes af patienter med tegn eller symptomer på endometriecancer, da sikkerheden ved anvendelse hos denne patientgruppe ikke er tilstrækkeligt undersøgt.
English: Any uterine bleeding during Optruma therapy is unexpected and should be fully investigated by a specialist.
Danish: Enhver uterin blødning, som forekommer under behandling med Optruma, er derfor uventet og bør undersøges grundigt af en specialist.
English: In contrast to the highly responsive ovaries in this rodent model, the human ovary after menopause is relatively unresponsive to reproductive hormonal stimulation.
Danish: I modsætning til de yderst følsomme ovarier i denne gnavermodel, er det humane ovarium efter menopausen forholdsvist upåvirkeligt af hormonal stimulation.
English: The hazard ratio for all VTE events in the RUTH study was HR = 1.44 (1.06 - 1.95).
Danish: Risikoforholdet (= hazard ratio) for alle VTE tilfælde i RUTH-studiet var HR = 1,44 (1,06 - 1,95).
English: Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine, because Optruma may not work as well.
Danish: Fortæl det til Deres læge, hvis De får colestyramin, der hovedsageligt anvendes som lipidsænkede medicin, da Optruma muligvis ikke virker så godt sammen med colestyramin.
English: Three trials included 1,764 postmenopausal women who were treated with Optruma and calcium or calcium supplemented placebo.
Danish: Tre studier inkluderede 1.764postmenopausale kvinder, som blev behandlet med Optruma og calcium eller placebo suppleret med calcium.
English: Also includes lactose See leaflet for further information
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også lactose Se indlægssedlen for yderligere information
English: Optruma was associated with reduced bone resorption and a mean positive shift in calcium balance of 60 mg per day, due primarily to decreased urinary calcium losses.
Danish: Optruma var forbundet med reduceret knogleresorption og en gennemsnitlig positiv forskydning af calciumbalancen på 60 mg pr. dag, hovedsagelig som følge af nedsat calciumtab med urinen.
English: Rare cases of moderate increases in AST and/or ALT have been reported where a causal relationship to raloxifene can not be excluded.
Danish: Sjældne tilfælde af moderate stigninger af ASAT og/eller ALAT, hvor en kausal sammenhæng med raloxifen ikke kan udelukkes, er observeret.
English: They are packed in blisters or in plastic bottles.
Danish: De fås i blisterpakninger eller i tabletglas af plastic.
English: However, there was an increase in death due to stroke in women assigned to raloxifene.
Danish: Der var dog en øget dødelighed som følge af apopleksi hos kvinder, der fik raloxifen.
English: If you forget to take Optruma
Danish: Hvis De har glemt at tage Optruma
English: Swallow the tablet whole.
Danish: Synk tabletten hel.
English: A similar frequency of increases was noted among placebo patients.
Danish: En tilsvarende frekvens af stigninger blev observeret hos placebobehandlede patienter.
English: Raloxifene is metabolised primarily in the liver.
Danish: Raloxifen metaboliseres hovedsageligt i leveren.
English: The time to reach average maximum plasma concentration and bioavailability are functions of systemic interconversion and enterohepatic cycling of raloxifene and its glucuronide metabolites.
Danish: Den tid, det tager at nå den gennemsnitlige maksimale plasmakoncentration og biotilgængelighed, afhænger af systemisk interkonvertering og enterohepatisk kredsløb af raloxifen og dets glukuronidmetabolitter.
English: It is unlikely that Optruma will cause vaginal bleeding.
Danish: Det er usandsynligt, at Optruma vil give blødning fra underlivet.
English: Optruma could harm your unborn child.
Danish: Optruma kunne skade det ufødte barn.
English: Endometrial thickness measurements in Optruma treated women were not different from baseline after 4 years of therapy.
Danish: Målinger af endometrietykkelsen hos Optruma-behandlede kvinder afveg ikke fra baseline efter 4 års behandling.
English: In addition, in a study with 2.5 x the recommended daily dose of Optruma there was no evidence of endometrial proliferation and no increase in uterine volume.
Danish: Endvidere viste en undersøgelse med 2,5 gange den anbefalede daglige dosis af Optruma ingen tegn på endometrieproliferation og ingen forøgelse af livmoderstørrelse.
English: The female rodents in these studies were treated during their reproductive lives, when their ovaries were functional and highly responsive to hormonal stimulation.
Danish: Hungnavere blev i disse undersøgelser behandlet i løbet af deres reproduktive liv, hvor deres ovarier var funktionelle og meget følsomme for hormonal stimulation.
English: In rare cases, blood levels of liver enzymes may increase during treatment with Optruma.
Danish: I sjældne tilfælde kan blodets indhold af leverenzymer stige under behandling med Optruma.
English: A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
Danish: En signifikant reduktion af forekomsten af vertebrale frakturer, men ikke hoftefrakturer, er påvist.
English: It does not matter what time of day you take your tablet but taking the tablet at the same time each day will help you remember to take it. You may take it with or without food.
Danish: Det er lige meget, hvornår på dagen De tager din tablet, men hvis De tager tabletten på samme tidspunkt hver dag, er det nemmere at huske.
English: Raloxifene may cause foetal harm when administered to a pregnant woman.
Danish: Raloxifen kan medføre fosterskader ved administration til gravide kvinder.
English: Concomitant use of vaginal oestrogen preparations was allowed in the clinical trial programme, if necessary to treat atrophic vaginal symptoms.
Danish: Samtidig brug af vaginale østrogenpræparater var tilladt i det kliniske studie, i givet fald til behandling af atrofiske vaginale symptomer.
English: Raloxifene has no effect on the pharmacokinetics of methylprednisolone given as a single dose.
Danish: Raloxifen har ingen effekt på farmakokinetikken af methylprednisolon, administreret som en enkelt dosis.
English: Raloxifene comprises less than 1 % of the combined concentrations of raloxifene and the glucuronide metabolites.
Danish: Raloxifen udgør mindre end 1% af den samlede koncentration af raloxifen og glukuronid metabolitter.
English: An effect on non-vertebral fractures has not been demonstrated.
Danish: En effekt på ikke-vertebrale frakturer er ikke påvist.
English: In a population pharmacokinetic study, a 47 % decrease in lean body mass adjusted creatinine clearance resulted in a 17 % decrease in raloxifene clearance and a 15 % decrease in the clearance of raloxifene conjugates.
Danish: I en populations-farmakokinetisk undersøgelse medførte et 47% fald i fedtfri legemsvægt-justeret creatinin-clearance et 17% fald i raloxifenclearance og et 15% fald i clearance af raloxifen-konjugater.
English: Titanium dioxide (E 171) Polysorbate 80
Danish: Titandioxid (E171) Polysorbat 80
English: These observations support the conclusion that raloxifene has no intrinsic oestrogen agonist activity in breast tissue.
Danish: Disse observationer støtter konklusionen, at raloxifen ikke udviser østrogen agonistaktivitet i brystvæv.
English: Superficial vein thrombophlebitis occurred in a frequency of less than 1 %.
Danish: Thrombophlebitis i overfladiske vener forekom med en frekvens på mindre end 1 %.
English: Optruma is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Danish: Optruma må kun anvendes af kvinder, der har passeret overgangsalderen og må ikke anvendes af kvinder, der stadig kan få børn.
English: Compared to placebo there was no increased use in Optruma treated patients.
Danish: I forhold til placebo var der ingen øget anvendelse hos de patienter, som blev behandlet med Optruma.