FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, before a 4-week treatment course with [invented name] is repeated, treatment should be reviewed, with special consideration given to any symptoms of endometrial hyperplasia or carcinoma.
Danish: Før gentagelse af et 4-ugers behandlingsforløb med [særnavn] bør der derfor tages stilling til behandlingen med særligt henblik på eventuelle symptomer på endometriehyperplasi eller -karcinom.
English: The maximum duration of treatment is 4 weeks.
Danish: Den maksimale behandlingsvarighed er 4 uger.
English: This medicine contains inactive ingredients (especially stearates) that may reduce the functionality of these products, thereby making them less reliable.
Danish: Dette lægemiddel indeholder inaktive hjælpestoffer (navnlig stearater), der kan forringe funktionen af latex-produkter, så de bliver mindre pålidelige
English: If symptoms persist beyond 4 weeks, alternative therapies should be considered.
Danish: Hvis symptomerne vedvarer i mere end 4 uger, bør andre behandlingsmuligheder overvejes.
English: Some studies including the WHI trial suggest that the long-term use of combined HRTs may confer a similar or slightly smaller risk (see Section 4.8).
Danish: Nogle studier, herunder WHI-studiet, tyder på, at langvarig kombineret hormonsubstitutionsterapi kan indebære en tilsvarende eller lidt mindre risiko (se pkt.
English: [invented name] is not indicated during pregnancy.
Danish: [særnavn] er ikke indiceret under graviditet.
English: For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life.
Danish: Behandling af postmenopausale symptomer med hormonsubstitution bør kun indledes ved symptomer, der forringer livskvaliteten.
English: When applied vaginally, estradiol is absorbed from the vaginal epithelium and enters the bloodstream in concentrations which are transiently above the postmenopausal range.
Danish: Ved vaginal applikation absorberes estradiol fra det vaginale epitel og indtræder i blodbanen i koncentrationer, der forbigående overstiger det postmenopausale interval.
English: If a dose is forgotten, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis glemmes, bør den tages, så snart patienten kommer i tanker om det. Der må ikke bruges en dobbelt dosis.
English: - Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer
Danish: - risikofaktorer for østrogenafhængige tumorer, f.eks. førstegrads arvelig disposition for mammacancer
English: No studies have been performed on the dermal absorption of oestradiol within the external female genital area from [invented name].
Danish: Der er ikke udført studier af den dermale absorption af estradiol fra de kvindelige ydre kønsorganer ved behandling med [særnavn].
English: It is used to relieve menopausal symptoms in the vagina such as dryness or irritation.
Danish: Det bruges til at lindre symptomer på overgangsalderen i skeden såsom tørhed eller irritation.
English: These may be signs of a liver disease - A large rise in your blood pressure (symptoms may be headache, tiredness, dizziness) - Any of the conditions mentioned in the ‘Do not use [invented name] ' section
Danish: Det kan være tegn på leversygdom - kraftig blodtryksstigning (symptomerne kan være hovedpine, træthed og svimmelhed) - hvis du har nogen af sygdommene nævnt under “Brug ikke [særnavn]”
English: Endometrial hyperplasia and carcinoma
Danish: Endometriehyperplasi og -karcinom
English: - Jaundice or deterioration in liver function
Danish: - ikterus eller forringet leverfunktion
English: At around ≥ 0.01% topically or systemically, estradiol widens the capillary vessels and promotes general blood perfusion.
Danish: Ved ca. ≥ 0,01 % topisk eller systemisk udvider estradiol kapillærerne og øger blodgennemstrømningen generelt.
English: In addition, estradiol also has rapid, non-genomic effects (signal transduction).
Danish: Derudover har estradiol hurtige ikke-genomiske virkninger (signaltransduktion).
English: Dosage instructions, method and duration of administration
Danish: Doseringsanvisninger, påføringsmetode og behandlingsvarighed
English: Before you start (or restart) HRT, your doctor will ask about your own and your family's medical history.
Danish: Før du påbegynder (eller genoptager) hormonerstatningsbehandling, vil lægen spørge til tidligere sygdomme hos dig og dine slægtninge.
English: − You should not use [invented name] immediately before sexual intercourse or as a lubricant.
Danish: Du må ikke tage en dobbeltdosis af [særnavn] som erstatning for en glemt enkeltdosis.
English: Effect of HRT on heart and circulation
Danish: Virkningen af hormonerstatningsbehandling på hjerte og kredsløb
English: - The level of risk is dependent on the duration of use (see section 4.4).
Danish: - Risikoen afhænger af behandlingsvarigheden (se pkt.
English: Similarly to other steroid hormones, estradiol acts directly on genetic information (DNA) via specific receptors following systemic administration.
Danish: Ligesom andre steroidhormoner virker estradiol direkte på den genetiske information (DNA) via specifikke receptorer efter systemisk administration.
English: You must always follow the directions for use; if not, [invented name] may not work properly.
Danish: Følg altid anvisningerne for brug af [særnavn], da der ellers er risiko for, at det ikke virker, som det skal.
English: Very rare (< 1/10,000),
Danish: Meget sjælden (<1/10 000)
English: It could be a sign that your endometrium has become thicker.
Danish: Det kan være et tegn på, at din livmoderslimhinde er fortykket.
English: In medical terms this is known as ‘vaginal atrophy'.
Danish: Den lægelige betegnelse er “vaginal atrofi”.
English: Similarly to other steroid hormones, estradiol acts directly on genetic information (DNA) via specific receptors.
Danish: Ligesom andre steroidhormoner virker estradiol direkte på den genetiske information (DNA) via specifikke receptorer.
English: [invented name] may only be used with special caution, after a thorough clinical evaluation of the risks and benefits, in the following cases:
Danish: I følgende tilfælde må [særnavn] kun bruges med særlig forsigtighed efter forudgående grundig klinisk vurdering af risici og fordele:
English: [invented name] should not be used in children or adolescents.
Danish: [særnavn] bør ikke anvendes hos børn eller unge.
English: Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.
Danish: Den objektive undersøgelse (herunder pelvis og mammae) bør tilpasses anamnese, kontraindikationer og advarsler vedrørende brugen.
English: In women with no personal history of VTE but with first degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).
Danish: Patienter, der ikke har venøs tromboemboli i anamnesen, men som har en førstegradsslægtning med trombose i ung alder i anamnesen, kan tilbydes screening efter grundig rådgivning om begrænsningerne heri (kun en del af trombofile defekter påvises ved screening).
English: The woman should be advised to contact her doctor in case bleeding or spotting occurs during treatment with [invented name].
Danish: Patienten skal informeres om at søge læge, hvis der optræder blødning eller pletblødning under behandlingen med [særnavn].
English: [Invented name] , is for short-term (4 weeks) local treatment in the vagina and the absorption into the blood is lower.
Danish: [særnavn] er til kortvarig (4 uger) lokal behandling i skeden, og kun en mindre del går over i blodet.
English: Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women.
Danish: Behandling af vaginal atrofi forårsaget af østrogenmangel hos postmenopausale kvinder.
English: This may include an examination of your breasts and/or internal examination, if necessary.
Danish: Undersøgelsen kan bestå i undersøgelse af brysterne og/eller om nødvendigt en gynækologisk undersøgelse.
English: For signs of a blood clot, see “Stop taking [invented name] and see a doctor immediately”.
Danish: Vedrørende tegn på blodprop: se “Du skal holde op med at bruge [særnavn] og straks kontakte lægen”.
English: Please talk to your doctor.
Danish: Tal med lægen om det.
English: [The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Danish: [Den eksisterende produktinformation rettes (med indsættelse, erstatning eller sletning af tekst), så den er i overensstemmelse med den vedtagne ordlyd, som fremgår af det følgende]
English: Therefore, for safety reasons, the maximum duration of treatment is limited to 4 weeks.
Danish: Af sikkerhedsmæssige årsager er behandlingsvarigheden derfor begrænset til 4 uger.
English: The occurrence of such an event is more likely in the first year of HRT than later.
Danish: Sådanne hændelser er mere sandsynlige i det første år med hormonsubstitutionsterapi end senere.
English: If you forget to use [invented name]
Danish: Hvis du har glemt at bruge [særnavn]
English: Part A. - 0.01% w/w estradiol containing medicinal products for topical use(as per Annex I)
Danish: Del A. - Lægemidler til lokal anvendelse indeholdende 0,01 w/w% estradiol (i henhold til bilag I)
English: As its active substance, [invented name] contains 17ß-estradiol, a natural sex hormone, at a concentration of 0.01%.
Danish: Som aktivt stof indeholder [særnavn] det naturlige kønshormon 17ß-estradiol i en koncentration af 0,01 %.
English: Generally recognised risk factors for VTE include use of oestrogens, older age, major surgery, prolonged immobilisation obesity (BMI>30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
Danish: Anerkendte risikofaktorer for venøs tromboemboli inkluderer anvendelse af østrogener, stigende alder, større kirurgiske indgreb, fedme som følge af langvarig immobilisering (BMI>30 kg/m2), graviditets- og post partum-perioden, systemisk lupus erythematosus og cancer.
English: Your doctor will decide how long you should use the cream, and whether further treatment is needed with a corticosteroid-free but high-dose oestradiol cream, or a cream containing no active substances.
Danish: Lægen vil tage stilling til, hvor længe du skal bruge cremen, og om du skal have yderligere behandling med en creme, der er kortikosteroid-fri, men indeholder en høj dosis af estradiol, eller en creme uden aktive stoffer.
English: Insert the contents of 1 filled applicator (= 2 g cream) before bedtime.
Danish: Tøm indholdet af 1 fyldt applikator (= 2 g creme) i skeden før sengetid.
English: Thus, estradiol affects transcription (RNA synthesis) and therefore stimulates the synthesis of specific proteins.
Danish: Estradiol virker således på transskriptionen (RNA-syntesen) og stimulerer derved syntesen af specifikke proteiner.
English: Women with pre-existing hypertriglyceridaemia should be followed closely during oestrogen replacement or hormone replacement therapy, since rare cases of large increases of plasma triglycerides leading to pancreatitis have been reported with oestrogen therapy in this condition.
Danish: Patienter med præeksisterende hypertriglyceridæmi bør følges tæt under østrogen- eller hormonsubstitutionsterapi, da der i sjældne tilfælde er beskrevet stærkt forhøjede plasmatriglycerider med deraf følgende pankreatitis ved østrogenterapi ved denne tilstand.
English: However, the metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Danish: Metaboliseringen af østrogener kan dog øges ved samtidig anvendelse af lægemidler, der vides at inducere lægemiddelmetaboliserende enzymer, specielt CYP-enzymer; dette gælder således antikonvulsiva (f.eks. phenobarbital, phenytoin, carbamazepin) og antiinfektiva (f.eks. rifampicin, rifabutin, nevirapin og efavirenz).
English: For more information, see ‘Blood clots in a vein (thrombosis)'.
Danish: Yderligere oplysninger findes under “Blodpropper i en vene (trombose)”.
English: Women already on chronic anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
Danish: For patienter, der i forvejen er i kronisk antikoagulationsbehandling, kræves nøje stillingtagen til benefit/risk-forholdet for hormonsubstitutionsterapi.
English: Observational studies have mostly reported a small increase in risk of having breast cancer diagnosed that is substantially lower than found in users of oestrogenprogestagen combinations.
Danish: Observationsstudier har som regel vist en lille stigning i risikoen for at få diagnosticeret mammacancer, men risikoen er væsentligt lavere end hos brugere af østrogen-gestagen-kombinationer.
English: A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Danish: Der er beskrevet en let forhøjet risiko for æggestokkræft hos kvinder, som får hormonerstatningsbehandling i mindst 5-10 år.
English: In addition, due to the content of the corticosteroid prednisolone in [invented name] , skin atrophy might occur with prolonged use, further increasing systemic exposure to oestradiol.
Danish: På grund af indholdet af kortikosteroidet prednisolon i [særnavn] kan længerevarende brug medføre hudatrofi, hvilket yderligere øger den systemiske eksponering for estradiol.
English: In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.
Danish: I Million Women-studiet resulterede 5 års hormonsubstitutionsterapi i 1 ekstra tilfælde pr. 2.500 brugere.
English: The extra risk depends on how long you take HRT.
Danish: Den forhøjede risiko afhænger af, hvor lang tid man bruger hormonerstatningsbehandling.
English: It is unknown whether prolonged treatment or repeated treatment courses will cause thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb (endometrial cancer).
Danish: Det vides ikke, om langvarig behandling eller gentagne behandlingsforløb vil medføre fortykkelse af livmoderslimhinden (endometrie-hyperplasi) og livmoderkræft.
English: During the first week of treatment, [invented name] should be applied every other day - i.e. at 48-hourly intervals - and twice a week thereafter (maintenance dose).
Danish: I den første behandlingsuge skal [særnavn] bruges hver anden dag - dvs. med 48 timers mellemrumderefter to gange om ugen (vedligeholdelsesdosis).
English: As well as its typical hormonal effects during the reproductive period, estradiol also exerts characteristic effects on the skin.
Danish: Foruden sine typiske hormonale virkninger i den fødedygtige alder har estradiol også karakteristiske virkninger på huden.
English: Oestrogens may cause fluid retention, and therefore patients with cardiac or renal dysfunction should be carefully observed.
Danish: Da østrogener kan medføre væskeretention, bør patienter med nedsat hjerte- eller nyrefunktion observeres nøje.
English: Risk of coronary artery disease
Danish: Risiko for koronararteriesygdom
English: Therapy with [invented name] should only be administered together with clinical monitoring.
Danish: Behandling med [særnavn] bør kun gives under klinisk overvågning.
English: - Otosclerosis
Danish: - otosklerose
English: As an active substance, [invented name] contains 17ß-estradiol (0.005%).
Danish: [særnavn] indeholder det aktive stof 17ß-estradiol (0,005 %).
English: The reported increase in endometrial cancer risk among systemic oestrogen-only users varies from 2- to 12-fold compared with non-users, depending on both duration of treatment and on oestrogen dose.
Danish: Hos brugere af østrogen alene angives risikoen for endometriecancer at være 2-12 gange risikoen hos ikke-brugere, afhængigt af behandlingsvarighed og østrogendosis.
English: Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone (as measured by protein-bound iodine (PBI)), T4 levels (by column or by radio-immunoassay) or T3 levels (by radio-immunoassay).
Danish: Østrogener øger thyroxinbindende globulin (TBG) med deraf følgende stigning i totalt cirkulerende thyroideahormon (målt som proteinbundet iod), T4 (målt ved søjle- eller ved radioimmunanalyse) eller T3 (målt ved radioimmunanalyse).
English: Venous thrombosis, pulmonary embolism
Danish: Venetrombose, lungeemboli
English: Prolonged use of [invented name] over extensive areas may only proceed with special caution, after a thorough clinical evaluation of the risks and benefits, in cases of: - endometriosis.
Danish: I følgende tilfælde må langvarig anvendelse af [særnavn] på større områder kun finde sted med særlig forsigtighed efter forudgående grundig klinisk vurdering af risici og fordele: - endometriose
English: HRT will not prevent memory loss.
Danish: Hormonerstatningsbehandling forebygger ikke hukommelsessvækkelse.
English: Additional cases per 1000 users over 5 years
Danish: Ekstra tilfælde pr. 1.000 brugere i en 5-årig periode
English: Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sexhormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively.
Danish: Andre bindingsproteiner i serum kan være forhøjede, således kortikoidbindende globulin og kønshormonbindende globulin, hvilket medfører stigning i henholdsvis cirkulerende kortikosteroider og kønssteroider.
English: [Invented name] should not be used for more than 4 weeks.
Danish: [særnavn] må ikke bruges længere end 4 uger.
English: In the first week of treatment, [invented name] should be applied on every other day, i.e. at 48-hourly intervals, and twice weekly thereafter (maintenance dose).
Danish: I den første behandlingsuge anvendes [særnavn] hver anden dag, dvs. med 48-timers mellemrum, derefter to gange om ugen (vedligeholdelsesdosis).
English: The doctor will decide on the duration of treatment, and whether further treatment is needed with a corticosteroid-free, high-dose oestradiol cream or a cream with no active substances.
Danish: Lægen vil tage stilling til behandlingstiden og yderligere behandling med en kortikosteroidfri højdosis estradiol-creme eller en creme uden aktive stoffer.
English: This relative risk is not dependent on age or on duration of use, but as the baseline risk is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age, see section 4.4.
Danish: Denne relative risiko afhænger ikke af alder eller behandlingsvarighed, men da baselinerisikoen er stærkt aldersafhængig, øges den samlede risiko for apopleksi med alderen hos kvinder i hormonsubstitutionsterapi, se pkt.
English: Estradiol is rapidly metabolised in the liver and intestinal tract to estrone and subsequently to estriol.
Danish: Estradiol metaboliseres hurtigt i leveren og tarmen til estron og efterfølgende til estriol.
English: [invented name] should not be applied intravaginally or on other parts of the internal genital area.
Danish: [særnavn] må ikke påføres intravaginalt eller på andre steder af de indre kønsorganer.
English: Oral oestrogen only* Oral combined oestrogen-progestogen
Danish: Oralt østrogen alene* Kombineret oralt østrogen-gestagen
English: Women over the age of 60 years who use oestrogen-progestagen HRT are slightly more likely to develop heart disease than those not taking any HRT.
Danish: Kvinder over 60 år, som får hormonerstatningsbehandling med østrogen-gestagen, har en lidt større risiko for at få hjertesygdom end de, der ikke får hormonerstatningsbehandling.
English: * No differentiation was made between ischaemic and haemorrhagic stroke
Danish: * Der er ikke skelnet mellem iskæmisk og hæmoragisk apopleksi.
English: Dizziness, headache, migraine, anxiety
Danish: Svimmelhed, hovedpine, migræne, angst
English: There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65.
Danish: Der er i et vist omfang bevis for en øget risiko for hukommelsessvækkelse hos kvinder, der begynder at bruge hormonerstatningsbehandling efter 65-års alderen.
English: If severe upper abdominal complaints, enlarged liver or signs of intra-adominal haemorrhage occur, a liver tumour should be considered in the differential diagnosis.
Danish: Ved svære gener fra øvre abdomen, forstørret lever eller tegn på intraabdominal blødning bør levertumor overvejes som differentialdiagnose.
English: HRT is therefore contraindicated in these patients (see section 4.3).
Danish: Hormonsubstitutionsterapi er derfor kontraindiceret hos sådanne patienter (se pkt.
English: If VTE develops after initiating therapy, the drug should be discontinued.
Danish: Hvis der opstår venøs tromboemboli efter indledning af behandlingen, bør lægemidlet seponeres.
English: The pharmacokinetic profile of [Invented name] shows that there is systemic absorption of estradiol during treatment, in concentrations which are transiently above the postmenopausal levels (see Section 5.2).
Danish: Den farmakokinetiske profil af [særnavn] viser, at behandlingen medfører systemisk absorption af estradiol i koncentrationer, der forbigående overstiger de postmenopausale niveauer (se pkt.
English: If you stop using [invented name]
Danish: Hvis du holder op med at bruge [særnavn]
English: Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones.
Danish: Ritonavir og nelfinavir er kendt som potente hæmmere, men virker kraftigt inducerende, når de anvendes sammen med steroidhormoner.
English: In rare cases benign, and in even rarer cases malignant liver tumours leading to isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as those contained in [invented name].
Danish: I sjældne tilfælde kan der opstå benigne og i endnu sjældnere tilfælde maligne tumorer med enkeltstående tilfælde af livstruende intraabdominal blødning efter anvendelse af hormoner som dem, [særnavn] indeholder.
English: Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis).
Danish: Cetylstearylalkohol kan forårsage lokal hudirritation (f.eks. kontaktdermatitis).
English: The following adverse reactions have been associated with oral and/or transdermal oestrogen therapy (class effects):
Danish: Følgende bivirkninger er blevet sat i forbindelse med oral og/eller transdermal østrogenbehandling (klasevirkninger):
English: Treatment should not exceed 4 weeks.
Danish: Behandlingen må ikke fortsætte ud over 4 uger.
English: Combined oestrogen-progestogen
Danish: Kombineret østrogen-gestagen