FrancophonIA/ELRC3.0 huggingface dataset:
English: No data are available on the concomitant use of raloxifene and agents used in the treatment of early or advanced breast cancer.
Danish: Der findes ikke tilgængelige data omkring samtidig brug af raloxifen og midler brugt i behandlingen af tidlig eller avanceret brystcancer.
English: Clinical trials showed that a 60 mg daily dose of raloxifene significantly decreased total cholesterol (3 to 6 %), and LDL cholesterol (4 to 10 %).
Danish: Kliniske lægemiddelforsøg har vist, at en daglig dosis af raloxifen på 60 mg signifikant nedsatte total kolesterol (3-6 %) og LDL-kolesterol (4-10 %).
English: Endometrial biopsies taken after six months therapy with raloxifene 60 mg daily demonstrated non-proliferative endometrium in all patients.
Danish: Endometriebiopsier, som blev taget efter seks måneders behandling med raloxifen 60 mg/dag, viste non-proliferative endometrier hos alle patienter.
English: So any vaginal bleeding while you take Raloxifene Teva is unexpected.
Danish: Enhver form for blødning fra underlivet, mens du tager Raloxifen Teva, er derfor uventet.
English: Raloxifene Teva belongs to a group of non-hormonal medicines called selective oestrogen receptor modulators (SERMs).
Danish: Raloxifen Teva tilhører en gruppe af ikke-hormonale lægemidler, som kaldes selektive østrogenreceptormodulatorer (SERM).
English: Raloxifene may affect the development of the baby.
Danish: Raloxifen kan påvirke barnets udvikling.
English: Any uterine bleeding during raloxifene therapy is unexpected and should be fully investigated by a specialist.
Danish: Enhver uterin blødning, som forekommer under behandling med raloxifen, er derfor uventet og bør undersøges grundigt af en specialist.
English: Term(s) included based on postmarketing experience.
Danish: Meget almindelig: Forhøjet blodtryka a Term(er) inkluderet på baggrund af postmarketing erfaringer.
English: Raloxifene 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: Raloxifen 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: Cholecystectomy rates for raloxifene (2.3 %) were not statistically significantly different from placebo (2.0 %).
Danish: Kolecystektomi-hyppigheden for raloxifen (2,3 %) var ikke statistisk signifikant forskellig fra placebo
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 April 2010
Danish: Dato for første markedsføringstilladelse: 29. april 2010.
English: Raloxifene 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: Raloxifen bør ikke anvendes af patienter med tegn eller symptomer på endometriecancer, da sikkerheden ved anvendelse hos denne patientgruppe ikke er tilstrækkeligt undersøgt.
English: There was no difference between treatment groups in the incidence of new nonvertebral fractures.
Danish: Der var ingen forskel mellem behandlingsgrupperne mht. forekomst af nye ikkevertebrale frakturer.
English: Do not take Raloxifene Teva if you are breast-feeding as it might be excreted in mother's milk.
Danish: Anvend ikke Raloxifen Teva hvis du ammer, da det muligvis udskilles i modermælk.
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 glukuronidmetabolitter.
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 mamma-tumorer hos rotter og mus.
English: A similar frequency of increases was noted among placebo patients.
Danish: En tilsvarende frekvens af stigninger blev observeret hos placebo-behandlede patienter.
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-forsøget var HR = 1,44 (1,06-1,95).
English: Raloxifene therapy for 8 years did not significantly affect the risk of cardiovascular events in patients enrolled in the osteoporosis treatment study.
Danish: Raloxifenbehandling i 8 år havde ingen signifikant effekt på risikoen for kardiovaskulære hændelser hos patienter, der medvirkede i osteoporosebehandlingsforsøget.
English: Three trials included 1,764 postmenopausal women who were treated with raloxifene and calcium or calcium supplemented placebo.
Danish: Tre lægemiddelforsøg inkluderede 1.764 postmenopausale kvinder, som blev behandlet med raloxifen og calcium eller placebo suppleret med calcium.
English: The PSUR submission schedule for Raloxifene Teva should follow PSUR submission schedule for the reference medicinal product.
Danish: Den planlagte PSUR-indsendelse for Raloxifen Teva bør følge den planlagte PSUR-indsendelse for referencelægemidlet.
English: Until safety and efficacy have been evaluated further in patients with hepatic insufficiency, the use of raloxifene is not recommended in this patient population.
Danish: Indtil sikkerhed og effekt er blevet undersøgt nærmere hos patienter med leverinsufficiens, kan brug af raloxifen ikke anbefales til denne patientgruppe.
English: In addition, in a study with 2.5 x the recommended daily dose of raloxifene 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 raloxifen ingen tegn på endometrieproliferation og ingen forøgelse af livmoderstørrelse.
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-farmako-kinetisk undersøgelse medførte et 47 % fald i fedtfri legemsvægt-justeret creatinin-clearance et 17 % fald i raloxifen-clearance og et 15 % fald i clearance af raloxifen-konjugater.
English: Raloxifene Teva could harm your unborn child.
Danish: Raloxifen Teva kunne skade det ufødte barn.
English: When determining the choice of raloxifene 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 raloxifen eller anden behandling, inklusive 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 afsnit 5.1).
English: It is unlikely that Raloxifene Teva will cause vaginal bleeding.
Danish: Det er usandsynligt, at Raloxifen Teva vil give blødning fra underlivet.
English: Polydextrose (E1200) Titanium dioxide (E171) Hypromellose (E464) Macrogol 4000
Danish: Polydextrose (E1200) Titandioxid (E171) Hypromellose (E464) Macrogol 4000
English: Raloxifene Teva can treat or prevent your osteoporosis only if you continue to take the tablets.
Danish: Raloxifen Teva kan kun behandle eller forebygge knogleskørhed, hvis du fortsætter med at tage tabletterne.
English: Endometrial thickness measurements in raloxifene treated women were not different from baseline after 4 years of therapy.
Danish: Målinger af endometrietykkelsen hos raloxifen-behandlede kvinder afveg ikke fra baseline efter 4 års behandling.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: Presystemic glucuronidation is exten sive.
Danish: Præsystemisk glukuronidering er omfattende.
English: Therefore, raloxifene should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Danish: Derfor bør raloxifen først anvendes til behandling eller forebyggelse af osteoporose, når behandlingen af brystcancer inklusive adjuverende behandling er tilendebragt.
English: 14 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Danish: Filmovertrukken tablet 14 filmovertrukne tabletter 28 filmovertrukne tabletter 84 filmovertrukne tabletter
English: In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene Teva.
Danish: I sjældne tilfælde kan blodets indhold af leverenzymer stige under behandling med Raloxifen Teva.
English: Raloxifene and oestrogen affect bone remodelling and calcium metabolism similarly.
Danish: Raloxifen og østrogen påvirker knogleombygningen og calciummetabolismen på samme måde.
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 for osteoporose.
English: During the whole length of the study concomitant use of other bone-active medications was permitted.
Danish: Under hele forsøgets længde var det tilladt samtidigt at bruge anden medicin med virkning på knoglerne.
English: Likewise, raloxifene 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 raloxifen 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: Swensweg 5, 2031 GA, Haarlem The Netherlands
Danish: Swensweg 5, 2031 GA, Haarlem Holland
English: - If you have severe kidney problems.
Danish: - hvis du har en alvorlig nyresygdom.
English: Raloxifene modestly increases hormone-binding globulin concentrations, including sex steroid binding globulins (SHBG), thyroxine binding globulin (TBG), and corticosteroid binding globulin (CBG), with corresponding increases in total hormone concentrations.
Danish: Raloxifen øger i beskedent omfang koncentrationerne af hormonbindende globulin, inklusive kønshormonbindende globuliner (SHBG), thyroxinbindende globulin (TBG) og kortikosteroidbindende globulin (CBG) med tilsvarende stigninger i totale hormonkoncentrationer.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan ramme flere end 1 ud af 10 patienter)
English: Superficial vein thrombophlebitis occurred in a frequency of less than 1 %.
Danish: Trombophlebitis i overfladiske vener forekom med en frekvens på mindre end 1 %.
English: If you forget to take Raloxifene Teva Take a tablet as soon as you remember and then continue as before.
Danish: Tag en tablet lige så snart, du husker det, og fortsæt derefter som før.
English: • Gallstones.
Danish: • Galdesten.
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: th 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 Dvitamintilskud.
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 slagtilfælde hos kvinder, der fik raloxifen.
English: • Increased risk of blood clots in the lungs (pulmonary embolism).
Danish: • Øget risiko for blodpropper i lungerne (lungeemboli).
English: It is not known whether raloxifene is excreted in human milk.
Danish: Det vides ikke, hvorvidt raloxifen udskilles i modermælk.
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 østrogenreceptorer samt regulering af genekspression.
English: Based on these risk factors, prevention of osteoporosis with raloxifene 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 raloxifen 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: Compared to placebo there was no increased use in raloxifene treated patients.
Danish: I forhold til placebo var der ingen øget anvendelse hos de patienter, som blev behandlet med raloxifen.
English: Raloxifene Teva is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Danish: Raloxifen Teva må kun anvendes af kvinder, der har passeret overgangsalderen og må ikke anvendes af kvinder, der stadig kan få børn.
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: If you stop taking Raloxifene Teva
Danish: Hvis du holder op med at tage Raloxifen Teva
English: Raloxifene is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with oestrogen deficiency.
Danish: Raloxifen er ikke effektivt til reduktion af vasodilatation (hedestigninger) eller andre menopausesymptomer, som er forbundet med østrogenmangel.
English: 6.5 Nature and contents of container Transparent PVC/PVdC - Aluminium blisters.
Danish: Transparente PVC/PVdC - Aluminiumblistere.
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: België/Belgique/Belgien Teva Pharma Belgium N.V./S.A.
Danish: Teva Pharma Belgium N.V./S.A.
English: Teva UK Ltd, Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG UK
Danish: Teva UK Ltd, Brampton Road Hampden Park, Eastbourne East Sussex, BN22 9AG England
English: Colloidal anhydrous silica Microcrystalline cellulose, silicified
Danish: Kolloid vandfri silica Mikrokrystallinsk cellulose, silicificeret
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, gamma-glutamyltransferase, alkalisk fosfatase, ALAT og ASAT, bør disse parametre overvåges nøje under behandlingen.
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-antagonister og benzodiazepiner.
English: - If you have active uterine cancer, as there is insufficient experience of Raloxifene Teva use in women with this disease.
Danish: - hvis du har aktiv livmoderkræft, da der er utilstrækkelig erfaring med Raloxifen Teva hos kvinder med denne sygdom.
English: Slightly decreased (6-10 %) platelet counts have been reported during raloxifene treatment in placebo-controlled clinical trials of raloxifene in osteoporosis.
Danish: Let nedsatte (6-10 %) trombocyttal er rapporteret under behandling med raloxifen i placebo-kontrollerede kliniske forsøg med raloxifen mod osteoporose.
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: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER FOR ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
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 %) raloxifenbehandlede kvinder af et apopleksi sammenlignet med 39 (0,8%) placebo-behandlede kvinder.
English: In postmenopausal women with osteoporosis, raloxifene reduces the incidence of vertebral fractures, preserves bone mass and increases bone mineral density (BMD).
Danish: Hos postmenopausale kvinder med osteoporose reducerer raloxifen forekomsten af vertebrale frakturer, bevarer knoglemassen og øger knoglemineraltætheden (BMD).
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 to-årig carcinogenicitetsundersøgelse af rotter observeredes en øget forekomst af ovarietumorer af granulosa-/thecacelleoprindelse hos højdosis-hunner (279 mg/kg/dag).
English: In the osteoporosis treatment study, significantly fewer raloxifene-treated patients required initiation of hypolipidaemic therapy compared to placebo.
Danish: I osteoporosebehandlingsundersøgelsen havde signifikant færre raloxifen-behandlede patienter behov for påbegyndelse af lipidsænkende behandling i forhold til placebo.
English: White to off-white, film coated, oval shaped tablets, embossed with the number “60” on one side and “N” on the other side of the tablet.
Danish: Hvide til offwhite filmovertrukne, ovale tabletter, præget med tallet "60" på den ene side og "N" på den anden side af tabletten.
English: Raloxifene reduced the incidence of clinical vertebral fractures by 35 % compared with placebo (HR 0.65, CI 0.47 0.89).
Danish: Raloxifen nedsatte forekomsten af kliniske vertebrale frakturer med 35 % sammenlignet med placebo (HR 0,65, konfidensinterval 0,47-0,89).
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 raloxifen-behandlede kvinder signifikant lavere end hos kvinder, som blev behandlet med den ene eller anden form for hormonal substitutionsbehandling.
English: Deutschland Teva GmbH Tel: +49 73140208
Danish: Teva GmbH Tel: +49 73140208
English: Do not use this medicine after the expiry date which is stated on the outer carton or foil after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Decrease in the number of the platelets in the blood
Danish: • Færre blodplader i blodet.
English: Tablet core: pregelatinized starch (maize), magnesium stearate, povidone (K30), colloidal anhydrous silica and microcrystalline cellulose, silicified.
Danish: Tabletkerne: Prægelatineret stivelse (majs), magnesiumstearat, povidon (K30), kolloid vandfri silica og mikrokrystallinsk cellulose, silicificeret.
English: Raloxifene does not stimulate breast tissue.
Danish: Raloxifen stimulerer ikke brystvæv.
English: Raloxifene (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Danish: Raloxifen (n = 317) blev i visse kliniske lægemiddelforsøg sammenlignet med hormonal substitutionsterapi, som blev givet som kontinuerlig (n = 110) eller cyklisk (n = 205) kombinationsbehandling.
English: Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Danish: Raloxifen er indiceret til behandling og forebyggelse af osteoporose hos postmenopausale kvinder.
English: Compared to placebo, raloxifene was not associated with spotting or bleeding or endometrial hyperplasia.
Danish: Sammen-lignet med placebo, var raloxifen ikke forbundet med pletblødning, blødning eller endometriehyperplasi.
English: • Flu syndrome.
Danish: • Influenzasymptomer.
English: Swallow the tablet whole.
Danish: Synk tabletterne hele.
English: The film-coated tablets are white to off-white, oval shaped and embossed with the number “60” on one side and “N” on the other side.
Danish: De filmovertrukne tabletter er hvide til offwhite ovale tabletter præget med nummeret "60" på den ene side og "N" på den anden side.
English: There was no difference between raloxifene and placebo treated women in the incidences of vaginal bleeding (spotting) or vaginal discharge.
Danish: Der var ingen forskel mellem raloxifen- og placebo-behandlede kvinder i forekomsten af vaginal blødning (pletblødning) eller vaginalt udflåd.
English: Raloxifene Teva mimics some of the helpful effects of oestrogen after the menopause.
Danish: Raloxifen Teva efterligner nogle af de gavnlige virkninger af østrogen efter overgangsalderen.
English: This finding should be considered when prescribing raloxifene for postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation.
Danish: Dette bør tages i betragtning, når der ordineres raloxifen til postmenopausale kvinder, der tidligere har haft slagtilfælde eller har andre signifikante risikofaktorer for slagtilfælde, såsom transitorisk cerebral iskæmi eller atrieflimren.
English: Raloxifene Teva 60 mg is available in pack sizes of 14, 28 and 84 film-coated tablets.
Danish: Raloxifen Teva 60 mg fås i pakningsstørrelser a 14, 28 eller 84 filmovertrukne tabletter.
English: In clinical trials, raloxifene did not stimulate the postmenopausal uterine endometrium.
Danish: I kliniske lægemiddelforsøg stimulerede raloxifen ikke det postmenopausale endometrium.
English: - If you are suffering from breast cancer, as there is insufficient experience of Raloxifene Teva use in women with this disease.
Danish: - hvis du har brystkræft, idet der er begrænset erfaring med brug af Raloxifen Teva hos kvinder med denne sygdom.
English: Raloxifene has no effect on the risk of ER negative breast cancers.
Danish: Raloxifen har ingen indvirkning på risikoen for østrogenreceptor-negativ brystcancer.
English: A relative risk of 1.60 (CI 0.95, 2.71) was observed in raloxifene treated patients compared to placebo.
Danish: En relativ risiko på 1,60 (konfidensinterval 0,95-2,71) blev observeret hos raloxifen-behandlede patienter i forhold til placebo.