FrancophonIA/ELRC3.0 huggingface dataset:
English: During the whole length of the study concomitant use of other bone-active medications was permitted.
Danish: Under hele studiets længde var det tilladt samtidigt at bruge anden medicin med virkning på knoglerne.
English: • If you have active uterine cancer, as there is insufficient experience of Optruma use in women with this disease.
Danish: • hvis De har aktiv livmoderkræft, da der er utilstrækkelig erfaring med Optruma hos kvinder med denne sygdom.
English: As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen.
Danish: Som en selektiv østrogen-receptor modulator (SERM) har raloxifen selektiv agonistisk eller antagonistisk effekt på væv, som påvirkes af østrogen.
English: Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile.
Danish: Behandlingen bør ikke genoptages før de omstændigheder, som medførte immobilisering, er ovre, og patienten er fuldt mobiliseret.
English: Optruma and oestrogen affect bone remodelling and calcium metabolism similarly.
Danish: Optruma og østrogen påvirker knogleombygningen og calciummetabolismen på samme måde.
English: The two most frequent diagnoses associated with uterine bleeding during raloxifene treatment were endometrial atrophy and benign endometrial polyps.
Danish: De to hyppigste diagnoser, som var relaterede til uterin blødning under behandling med raloxifen, var endometrieatrofi og benigne endometriepolypper.
English: However, since the overall extent of absorption and the elimination rate of raloxifene are not affected, raloxifene can be concurrently administered with ampicillin.
Danish: Eftersom den totale absorption og eliminationshastigheden af raloxifen imidlertid ikke ændres, kan raloxifen administreres samtidig med ampicillin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (ALL BLISTER PACKS):
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER (ALLE BLISTERPAKNINGER)
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Danish: Følgende konvention er brugt til klassifikation af bivirkningerne: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000) og meget sjælden (<1/10.000).
English: Raloxifene is absorbed rapidly after oral administration.
Danish: Raloxifen absorberes hurtigt efter peroral administration.
English: The blister boxes contain 14, 28 or 84 tablets.
Danish: Blisterpakningerne indeholder 14, 28 eller 84 tabletter.
English: • If you are allergic (hypersensitive) to raloxifene or any of the other ingredients of this medicine
Danish: • hvis De er allergisk (overfølsom) over for raloxifen eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: In general, it does not change triglycerides or HDL ("good") cholesterol.
Danish: Generelt set påvirker det hverken triglycerider eller HDL (”sundt”) kolesterol.
English: Bone loss is particularly rapid for the first 10 years after menopause when the compensatory increase in bone formation is inadequate to keep up with resorptive losses.
Danish: Knogletabet forløber særligt hurtigt i løbet af de første 10 år efter menopausen, fordi den kompenserende knogledannelse ikke er tilstrækkelig til at opveje knogleresorptionen.
English: There is no specific antidote for raloxifene hydrochloride.
Danish: Der er ingen specifik antidot til raloxifenhydrochlorid.
English: Raloxifene is distributed extensively in the body.
Danish: Raloxifen fordeles i vid udstrækning i organismen.
English: Therefore, Optruma should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Danish: Derfor bør Optruma først anvendes til behandling eller forebyggelse af osteoporose, når behandlingen af brystcancer inklusiv adjuverende behandling er tilendebragt.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til oral anvendelse
English: After 4 years, raloxifene did not increase the risk of endometrial or ovarian cancer.
Danish: Efter 4 år har raloxifen ikke øget risikoen for endometrie- eller ovariecancer.
English: Raloxifene levels are maintained by enterohepatic recycling, giving a plasma half-life of 27.7 hours.
Danish: Koncentrationen af raloxifen opretholdes ved hjælp af det enterohepatiske kredsløb, hvilket resulterer i en plasmahalveringstid på 27,7 timer.
English: • If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness as these may increase your risk of blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
Danish: • hvis De ikke kan bevæge Dem normalt i nogen tid, fordi De sidder i kørestol, skal på hospitalet eller ligge i sengen efter en operation eller en uventet sygdom, da dette kan øge Deres risiko for blodpropper (blodprop i benene, blodprop i lungerne eller blodprop i øjets nethinde).
English: • Swelling of hands, feet and legs (peripheral oedema)
Danish: • Hævede hænder, fødder og ben (perifer væskeophobning):
English: Concurrent administration of either calcium carbonate or aluminium and magnesium-hydroxide containing antacids do not affect the systemic exposure of raloxifene.
Danish: Samtidig administration af antacida, som indeholder calciumcarbonat, aluminium- eller magnesiumhydroxid, påvirker ikke den systemiske eksponering for raloxifen.
English: c. Description of selected adverse reactions
Danish: c. Beskrivelse a udvalgte bivirkninger
English: • If you are suffering from breast cancer, as there is insufficient experience of Optruma use in women with this disease.
Danish: • hvis De har brystkræft, idet der er begrænset erfaring med brug af Optruma hos kvinder med denne sygdom.
English: Likewise, Optruma is indicated for the treatment of osteoporosis or established osteoporosis in women with BMD of the spine 2.5 SD below the mean value of a normal young population and/or with vertebral fractures, irrespective of BMD.
Danish: Ligeledes er Optruma indiceret til behandling af osteoporose eller etableret osteoporose hos kvinder med BMD af rygsøjlen på 2,5 SD under middelværdien for en normal ung population og/eller med vertebrale frakturer, uanset BMD.
English: Raloxifene is associated with an increased risk for venous thromboembolic events that is similar to the reported risk associated with current use of hormone replacement therapy.
Danish: Raloxifen er forbundet med en øget risiko for venøse tromboemboliske sygdomme, der er i samme størrelsesorden som den risiko, der er rapporteret for gængs brug af hormonal substitutionsterapi.
English: It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
Danish: Raloxifen virker som en agonist på knoglevæv og virker delvist på kolesterol metabolisme (fald i total og LDL-kolesterol), men ikke på hypothalamus eller på uterint væv eller brystvæv.
English: Blister boxes contain 14, 28, or 84 tablets.
Danish: Blisterpakninger indeholder 14, 28 eller 84 tabletter.
English: Its clinical use, therefore, cannot be recommended in breastfeeding women.
Danish: Derfor kan klinisk anvendelse ikke anbefales til ammende kvinder.
English: Optruma is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
Danish: Optruma er ikke effektivt til reduktion af vasodilatation (hedestigninger) eller andre menopausesymptomer, som er forbundet med østrogenmangel.
English: Plasma raloxifene concentrations were approximately 2.5-fold higher than in controls and correlated with bilirubin concentrations.
Danish: Plasmakoncentrationerne af raloxifen var ca. 2,5 gange højere end hos kontrolgruppen og korrelerede med bilirubinkoncentrationer.
English: Raloxifene should not be co-administered with cholestyramine (or other anion exchange resins), which significantly reduces the absorption and enterohepatic cycling of raloxifene.
Danish: Raloxifen bør ikke administreres samtidig med colestyramin (eller andre anionbyttere), idet absorptionen og det enterohepatiske kredsløb af raloxifen hermed reduceres signifikant.
English: When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
Danish: Når valget mellem Optruma eller anden behandling, inklusiv østrogener, skal tages for den enkelte postmenopausale kvinde, bør menopausale symptomer, effekt på uterint væv og brystvæv og kardiovaskulære risici og fordele indgå i overvejelserne (se pkt.
English: Optruma is only for use in postmenopausal women.
Danish: Optruma må kun anvendes af postmenopausale kvinder.
English: Based on these risk factors, prevention of osteoporosis with Optruma is indicated for women within ten years of menopause, with BMD of the spine between 1.0 and 2.5 SD below the mean value of a normal young population, taking into account their high lifetime risk for osteoporotic fractures.
Danish: Baseret på disse risikofaktorer er osteoporoseforebyggelse med Optruma indiceret hos kvinder inden for ti år efter menopausen med BMD af rygsøjlen mellem 1,0 og 2,5 SD under middelværdien for en normal ung population, under hensyntagen til deres høje livstidsrisiko for osteoporotiske frakturer.
English: In vitro, raloxifene did not interact with the binding of warfarin, phenytoin, or tamoxifen.
Danish: Raloxifen interagerede ikke in vitro med proteinbindingen af warfarin, phenytoin eller tamoxifen.
English: Optruma has no effect on the risk of ER negative breast cancers.
Danish: Optruma har ingen indvirkning på risikoen for østrogenreceptornegativ brystcancer.
English: Hepatic insufficiency - The pharmacokinetics of a single dose of raloxifene in patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) have been compared to that in healthy individuals.
Danish: Leverinsufficiens - Farmakokinetikken af en enkelt dosis af raloxifen hos patienter med cirrose og mild leverfunktionsnedsættelse (Child-Pugh klasse A) er blevet sammenlignet med raske personer.
English: Raloxifene's biological actions, like those of oestrogen, are mediated through high affinity binding to oestrogen receptors and regulation of gene expression.
Danish: De biologiske virkninger af raloxifen er ligesom for østrogen medieret gennem binding med høj affinitet til østrogen-receptorer samt regulering af genekspression.
English: Other risk factors which may lead to the development of osteoporosis include early menopause; osteopenia (at least 1 SD below peak bone mass); thin body build; Caucasian or Asian ethnic origin; and a family history of osteoporosis.
Danish: Andre risikofaktorer, som kan føre til udvikling af osteoporose, inkluderer tidlig menopause, osteopeni (mindst 1 SD under maksimal knoglemasse), spinkel legemsbygning, kaukasisk eller asiatisk oprindelse og familiær disposition.
English: There were no differences between the raloxifene and placebo groups with respect to the incidence of reported uterine bleeding.
Danish: Der var ingen forskel mellem raloxifen- og placebogruppen med hensyn til forekomsten af rapporteret uterin blødning.
English: Lilly S.A., Avda.
Danish: Fremstiller Lilly S.A., Avda.
English: The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology.
Danish: Fordele og risici bør afvejes hos patienter med risiko for venøs tromboemboli af enhver ætiologi.
English: The incidence of breast symptoms and uterine bleeding in raloxifene treated women was significantly lower than in women treated with either form of HRT.
Danish: Forekomsten af brystsymptomer og uterin blødning var hos raloxifenbehandlede kvinder signifikant lavere end hos kvinder, som blev behandlet med den ene eller anden form for hormonal substitutionsbehandling.
English: When given during the preimplantation period, raloxifene delayed and disrupted embryo implantation resulting in prolonged gestation and reduced litter size but development of offspring to weaning was not affected.
Danish: Når raloxifen blev givet i præimplantationsperioden forsinkede og afbrød raloxifen embryoimplantationen, hvilket resulterede i forlænget drægtighed og reduceret kuldstørrelse, men påvirkede ikke udviklingen af afkommet i perioden frem til afvænning.
English: In the osteoporosis treatment study, significantly fewer Optruma-treated patients required initiation of hypolipidaemic therapy compared to placebo.
Danish: I osteoporosebehandlingsundersøgelsen havde signifikant færre Optruma-behandlede patienter behov for påbegyndelse af lipidsænkende behandling i forhold til placebo.
English: In clinical trials, Optruma did not stimulate the postmenopausal uterine endometrium.
Danish: I kliniske studier stimulerede Optruma ikke det postmenopausale endometrium.
English: Bottles contain 100 tablets.
Danish: Tabletglas indeholder 100 tabletter.
English: In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9 % compared to 0.3 % in women who received placebo treatment.
Danish: Hos postmenopausale kvinder, som var i raloxifenbehandling i 4 år, blev benigne endometriepolypper rapporteret hos 0,9 % i forhold til 0,3 % hos kvinder, som var i placebo-behandling.
English: At doses of 0.1 to 10 mg/kg/day in female rats, raloxifene disrupted estrous cycles of female rats during treatment, but did not delay fertile matings after treatment termination and only marginally reduced litter size, increased gestation length, and altered the timing of events in neonatal development.
Danish: Ved doser på 0,1 til 10 mg/kg/dag til hunrotter afbrød raloxifen østralcykli under behandlingen, men forsinkede ikke fertile parringer efter behandlingens ophør og reducerede kun marginalt kuldstørrelsen, øgede drægtighedsperioden og ændrede tidspunktet for de neonatale udviklingstrin.
English: Optruma mimics some of the helpful effects of oestrogen after the menopause.
Danish: Optruma efterligner nogle af de gavnlige virkninger af østrogen efter overgangsalderen.
English: After 3 years of treatment, at least a 5 mm increase in endometrial thickness, assessed with transvaginal ultrasound, was observed in 1.9 % of the 211 women treated with raloxifene 60 mg/day compared to 1.8 % of the 219 women who received placebo.
Danish: Efter 3 års behandling blev en øgning af endometrietykkelsen på mindst 5 mm, målt med transvaginal ultralyd, observeret hos 1,9% af de 211 kvinder, som blev behandlet med raloxifen 60 mg/dag, sammenlignet med 1,8% af de 219 kvinder, som blev behandlet med placebo.
English: b. Tabulated summary of adverse reactions
Danish: b. Tabuleret resumé over bivirkninger
English: c) Effects on the endometrium and on the pelvic floor
Danish: c) Effekt på endometriet og på bækkenbunden
English: Hepatic impairment including cholestasis.
Danish: Leverfunktionsnedsættelse inklusive cholestasis.
English: Optruma does not stimulate breast tissue.
Danish: Optruma stimulerer ikke brystvæv.
English: In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/kg) and hydrocephaly (≥ 10 mg/kg) were seen.
Danish: Hos kaniner sås svangerskabsafbrydelse og en lav forekomst af ventrikelseptumdefekter (≥0,1 mg/kg) og hydrocephalus (≥10 mg/kg).
English: Replacement therapies generally reverse the excessive resorption of bone.
Danish: Substitutionsbehandling modvirker som regel den ekscessive knogleresorption.
English: • Increased risk of blood clots in the lungs (pulmonary embolism)
Danish: • Øget risiko for blodpropper i lungerne (lungeemboli)
English: Tablet coating: Titanium dioxide (E 171), polysorbate 80, hypromellose, macrogol 400, carnauba wax.
Danish: Tabletovertræk: Titandioxid (E 171), polysorbat 80, hypromellose, macrogol 400, carnaubavoks.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Danish: Yderligere oplysninger om Optruma findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: The bottles contain 100 tablets.
Danish: Tabletglassene indeholder 100 tabletter.
English: Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
Danish: Sammenlignet med placebo, var raloxifen ikke forbundet med pletblødning, blødning eller endometriehyperplasi.
English: Slightly decreased (6-10 %) platelet counts have been reported during raloxifene treatment in placebocontrolled clinical trials of raloxifene in osteoporosis.
Danish: Let nedsatte (6-10%) trombocyttal er rapporteret under behandling med raloxifen i placebokontrollerede kliniske studie med raloxifen mod osteoporose.
English: There was no difference between Optruma and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Danish: Der var ingen forskel mellem Optruma- og placebo-behandlede kvinder i forekomsten af vaginal blødning (pletblødning) eller vaginalt udflåd.
English: In the RUTH study, raloxifene did not affect the incidence of stroke, compared to placebo.
Danish: I RUTH-studiet, påvirkede raloxifen ikke forekomsten af slagtilfælde, sammenlignet med placebo.
English: In children, symptoms of accidental overdose included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
Danish: Hos børn omfatter de rapporterede symptomer ataksi, svimmelhed, opkastning, udslæt, diarre, rysten og rødmen samt stigning i alkalisk fosfatase.
English: Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4'glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′-diglucuronide.
Danish: Raloxifen undergår omfattende first pass metabolisme til glukuronid-konjugater: raloxifen-4'glukuronid, raloxifen-6-glukuronid og raloxifen-6,4'-diglukuronid.
English: Optruma (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Danish: Optruma (n = 317) blev i visse kliniske lægemiddelstudier sammenlignet med hormonal substitutionsterapi, som blev givet som kontinuerlig (n = 110) eller cyklisk (n = 205) kombinationsbehandling.
English: In a 2-year carcinogenicity study in rats, an increase in ovarian tumors of granulosa/theca cell origin was observed in high-dose females (279 mg/kg/day).
Danish: I en toårig carcinogenicitetsundersøgelse af rotter observeredes en øget forekomst af ovarietumorer af granulosa-/thecacelle oprindelse hos højdosis hunner (279 mg/kg/dag).
English: During an average follow-up of 5.6 years, 59 (1.2%) raloxifene-treated women died due to a stroke compared to 39 (0.8%) placebo-treated women.
Danish: I løbet af en gennemsnitlig opfølgningstid på 5,6 år døde 59 (1,2%) raloxifen-behandlede kvinder af et apopleksi sammenlignet med 39 (0,8%) placebo-behandlede kvinder.
English: Due to the nature of this disease process, Optruma is intended for long term use.
Danish: Optruma er beregnet til langvarig brug på grund af karakteren af sygdomsprocessen.
English: Raloxifene has no or negligible influence on the ability to drive and use machines.
Danish: Raloxifen påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: In postmenopausal women with osteoporosis, Optruma reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Danish: Hos postmenopausale kvinder med osteoporose reducerer Optruma forekomsten af vertebrale frakturer, bevarer knoglemassen og øger knoglemineraltætheden (BMD).
English: Optruma is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Danish: Optruma er indiceret til behandling og forebyggelse af osteoporose hos postmenopausale kvinder.
English: BOTTLE LABEL, BOTTLE CARTON:
Danish: TABLETGLAS ETIKET, TABLETGLAS KARTON
English: Across all placebo-controlled trials, Optruma was indistinguishable from placebo with regard to frequency and severity of breast symptoms (no swelling, tenderness and breast pain).
Danish: I alle placebokontrollerede studier var der ingen forskel mellem Optruma og placebo med hensyn til frekvens og sværhedsgrad af brystsymptomer (ingen hævelse, ømhed og brystsmerter).
English: d) Effects on breast tissue
Danish: d) Effekt på brystvæv
English: Superficial vein thrombophlebitis occurred in a frequency of 1 % in the raloxifene group and 0.6 % in the placebo group.
Danish: Thrombophlebitis i overfladiske vener forekom med en frekvens på 1% i raloxifengruppen og 0,6% i placebogruppen.
English: Frequently co-administered medicinal products included: paracetamol, non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid, ibuprofen, and naproxen), oral antibiotics, H1 antagonists, H2 antagonists, and benzodiazepines.
Danish: Lægemidler, som hyppigt blev anvendt samtidig med raloxifen, omfattede: paracetamol, nonsteroide antiinflammatoriske stoffer (såsom acetylsalicylsyre, ibuprofen og naproxen), perorale antibiotika, H1- og H2-receptorantagonister og benzodiazepiner.
English: INFORMATION IN BRAILLE
Danish: INFORMATION I BRAILLE-SKRIFT Optruma
English: Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Danish: Hvis der observeres forhøjede værdier af total-serumbilirubin, gammaglutamyltransferase, alkalisk fosfatase, ALAT og ASAT, bør disse parametre overvåges nøje under behandlingen.
English: A relative risk of 1.60 (CI 0.95, 2.71) was observed in Optruma treated patients compared to placebo.
Danish: En relativ risiko på 1,60 (konfidensinterval 0,95-2,71) blev observeret hos Optruma-behandlede patienter i forhold til placebo.
English: Ink: Shellac, propylene glycol, indigo carmine (E 132).
Danish: Blæk: Shellac, propylenglycol, indigotin I (E 132).
English: Optruma contains the active substance raloxifene hydrochloride.
Danish: Optruma indeholder det aktive indholdsstof raloxifenhydrochlorid.
English: Optruma lowers total cholesterol and LDL ("bad") cholesterol.
Danish: Optruma sænker det samlede kolesterol og LDL (”farligt”) kolesterol.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: De kan finde yderligere oplysninger om Optruma på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Safety information following 3 years of raloxifene treatment suggests that raloxifene treatment does not increase pelvic floor relaxation and pelvic floor surgery.
Danish: Sikkerhedsdata baseret på 3 års raloxifenbehandling indikerer, at raloxifenbehandling ikke forøger svækkelse af bækkenbunden samt risikoen for et operativt indgreb i bækkenbunden.
English: Flu syndrome was reported by 16.2 % of Optruma treated patients and 14.0 % of placebo treated patients.
Danish: Influenzalignende syndrom blev rapporteret af 16,2 % af de patienter, som blev behandlet med Optruma, og af 14,0 % af de patienter, som blev behandlet med placebo.
English: Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) produced plasma concentrations of raloxifene which were approximately 2.5 times the controls.
Danish: Enkeltdoser af raloxifen, som blev givet til patienter med cirrose og mild leverfunktionsnedsættelse (Child-Pugh klasse A), medførte plasmakoncentrationer af raloxifen, som var 2,5 gange højere end hos kontrolgruppen.