FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use [invented name] if - You are allergic (hypersensitive) to estradiol or any of the other ingredients of [invented name] (listed in Section 6 Further information) - You have or have ever had breast cancer, or you are suspected of having it - You have or have ever had cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or you are suspected of having it - You have any unexplained vaginal bleeding - You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated - You have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) - You have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) - You have or have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina - You have or have ever had a liver disease and your liver function tests have not returned to normal - You have a rare blood problem called “porphyria”, which is passed down in families (inherited).
Danish: Brug ikke [særnavn]: - hvis du er allergisk over for estradiol eller et af de andre indholdsstoffer i [særnavn] (angivet i punkt 6 Yderligere oplysninger) - hvis du har eller nogensinde har haft brystkræft, eller der er mistanke om, at du har det - hvis du nogensinde har haft en østrogenfølsom kræftsygdom, såsom livmoderkræft, eller der er mistanke om, at du har det - hvis du bløder fra skeden af ukendt årsag - hvis du har fortykkelse af livmoderslimhinden (endometrie-hyperplasi), der ikke er under behandling - hvis du har eller nogensinde har haft en blodprop i en vene (trombose), f.eks. i benene (dyb venetrombose) eller i lungerne (lungeemboli) - hvis du har en forstyrrelse i blodets koagulation (såsom mangel på protein C, protein S eller antitrombin) - hvis du har eller for nylig har haft en sygdom forårsaget af blodpropper i arterierne, såsom hjerteanfald, slagtilfælde eller hjertekrampe (angina) - hvis du har eller nogensinde har haft en leversygdom, og prøverne for din leverfunktion ikke er blevet normale igen - hvis du har den sjældne arvelige blodsygdom “porfyri”.
English: Common ≥ 1/100 to < 1/10 (≥ 1% and
Danish: Almindelig ≥ 1/100 til < 1/10 (≥ 1 % og
English: HRT, especially oestrogen-progestagen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Danish: Hormonsubstitutionsterapi, navnlig med kombineret østrogen-gestagen, øger tætheden på en mammografi, hvilket kan vanskeliggøre radiologisk påvisning af mammacancer.
English: - breast cancer - endometrial hyperplasia and carcinoma - ovarian cancer - blood clots in the veins of the legs of lungs (venous thromboembolism) - heart disease - stroke - probable memory loss if Hormone Replacement Therapy is started over the age of 65
Danish: - brystkræft - fortykkelse af livmoderslimhinden (endometrie-hyperplasi) og livmoderkræft - æggestokkræft - blodpropper i venerne i benene og i lungerne (venøs tromboemboli) - hjertesygdom - slagtilfælde - mistanke om hukommelsessvækkelse, hvis hormonerstatningsbehandlingen påbegyndes i en alder over 65 år
English: You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you.
Danish: Efterhånden som du bliver ældre, stiger risikoen for en blodprop i venerne; risikoen er desuden øget, hvis noget af følgende gælder for dig.
English: The following risks apply to HRT medicines which circulate in the blood.
Danish: Følgende risici er knyttet til hormonerstatningsbehandling, når hormonerne optages i blodet.
English: Nausea, bloating, abdominal pain
Danish: Kvalme, oppustethed, abdominalsmerter
English: If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe' (e.g. antithrombin, protein S, or protein C deficiencies or a combination of defects) HRT is contraindicated.
Danish: Hormonsubstitutionsterapi er kontraindiceret, hvis der påvises en trombofil defekt, som viser sig som trombose hos familiemedlemmer eller er af “svær” grad (f.eks. mangel på antitrombin, protein S eller protein C eller en kombination heraf).
English: For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown.
Danish: For kvinder, som har fået fjernet livmoderen, og som i fem år bruger hormonerstatningsbehandling med østrogen alene, ses ingen eller kun let forhøjet risiko for brystkræft.
English: Section 4.4 Special warnings and precautions for use [All current text in this section should be deleted and replaced by the text below]
Danish: Punkt 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen [Hele den nuværende tekst under dette punkt slettes og erstattes af nedenstående tekst]
English: Transient, mild local irritation (e.g. pruritus, burning).
Danish: Forbigående let lokal irritation (f.eks. pruritus, brændende fornemmelse).
English: Other adverse reactions have been reported in association with oestrogen/progestogen treatment.
Danish: Der er indberettet andre bivirkninger i forbindelse med østrogen/gestagenbehandling.
English: [invented name] (approximately 1 cm of cream) is thinly applied once daily with the fingers onto diseased skin areas of the external female genital area and then gently rubbed in.
Danish: [særnavn] (ca. 1 cm creme) appliceres én gang dagligt i et tyndt lag med fingrene på de syge hudområder af de ydre kønsorganer og indgnides forsigtigt.
English: The risk of coronary artery disease is slightly increased in users of combined oestrogenprogestogen HRT over the age of 60 (see section 4.4).
Danish: Der er en let øget risiko for koronararteriesygdom ved kombineret østrogen-gestagenhormonsubstitutionsbehandling hos brugere over 60 år (se pkt.
English: Oestrogens stimulate epithelial cell proliferation in the genital area and urinary tract, as well as increasing collagen synthesis in the skin.
Danish: Østrogener stimulerer proliferationen af epitelceller i genitalieområdet og urinvejene og øger kollagensyntesen i huden.
English: If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>.
Danish: Hvis du får bivirkninger, skal du tale med lægen, apotekspersonalet eller sygeplejersken.
English: [This section should have all of the following text]
Danish: [Dette punkt skal indeholde hele den følgende tekst]
English: [Invented name] should not be used immediately prior to sexual intercourse or as a lubricant, in order to avoid possible undesirable effects in the partner.
Danish: [særnavn] må ikke anvendes umiddelbart før coitus eller som smøremiddel, da dette kan medføre uønskede virkninger hos partneren.
English: [invented name] is a cream containing estradiol for vaginal use.
Danish: [særnavn] er en creme, der indeholder estradiol til brug i skeden.
English: - Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestogen combinations.
Danish: - For brugere af østrogener alene er den mulige forøgelse af risikoen væsentligt mindre end for brugere af østrogen-gestagenkombinationer.
English: Incidence per 1000 women placebo arm over 5 year period*
Danish: Incidens pr. 1.000 kvinder i placeboarmen over en 5-årig periode*
English: − when using [invented name] at the same time as latex products (e.g. condoms, diaphragms).
Danish: − hvis du anvender [særnavn] sammen med produkter af latex (f.eks. kondom, pessar).
English: If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Danish: Hvis der opstår blødning eller pletblødning på noget tidspunkt under behandlingen, skal årsagen hertil udredes, hvilket kan indebære endometriebiopsi til udelukkelse af endometriel malignitet.
English: Stop using [invented name] and see a doctor immediately
Danish: Du skal holde op med at bruge [særnavn] og straks kontakte lægen,
English: Vigilance is required for possible systemic side effects and skin atrophy.
Danish: Patienten skal overvåges for mulige systemiske bivirkninger og hudatrofi.
English: Take special care when using [invented name] together with latex products (e.g. condoms, diaphragms), as it contains excipients (other ingredients, particularly stearates) which can reduce the functionality of such products, thereby making them less reliable.
Danish: Vær særlig forsigtig med at bruge [særnavn] sammen med latex-produkter (f.eks. kondomer eller pessarer), da det indeholder hjælpestoffer, navnlig stearater, der kan nedsætte latexproduktets funktion, så det er mindre pålideligt.
English: If unexpected genital bleeding occurs, treatment should be discontinued, the reason should be investigated which may include vaginal ultrasound investigation and endometrial biopsy to exclude endometrial hyperplasia or malignancy.
Danish: Ved uventet genital blødning bør behandlingen seponeres og årsagen udredes, hvilket kan indebære ultralydsundersøgelse af vagina samt endometriebiopsi til udelukkelse af endometriehyperplasi eller -malignitet.
English: Women with an intact uterus with abnormal bleeding of unknown aetiology or women with an intact uterus who have previously been treated with unopposed oestrogens should be examined with special care in order to exclude hyperstimulation/malignancy of the endometrium before initiation of treatment with [invented name]
Danish: Patienter med intakt uterus med abnorm blødning af ukendt årsag og patienter med intakt uterus, som tidligere er blevet behandlet med østrogener alene, bør før initiering af behandling med [særnavn] undersøges særlig omhyggeligt for at udelukke hyperstimulation af endometriet eller endometriel malignitet.
English: For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease.
Danish: Kvinder, der har fået fjernet livmoderen og er i behandling med østrogen alene, har ikke en forhøjet risiko for hjertesygdom.
English: Chloasma/melasma, hirsutism, pruritus, rash
Danish: Kloasma/melasma, hirsutisme, pruritus, udslæt
English: − if you suffer or have suffered from endometriosis and have undergone hysterectomy (removal of the womb)
Danish: − hvis du har eller har haft livmoderslimhinde uden for livmoderen (endometriose) og har fået fjernet livmoderen (hysterektomi)
English: - painful swelling and redness of the legs - sudden chest pain - difficulty in breathing
Danish: - ømme, hævede og røde ben - pludselige smerter i brystet - vejrtrækningsbesvær
English: Take special care with [invented name]
Danish: Vær ekstra forsigtig med at bruge [særnavn]
English: − if you have ever developed malignant tumours which are sensitive to oestrogens
Danish: − hvis du nogensinde har haft en østrogenfølsom ondartet svulst
English: Therefore caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis.
Danish: Forsigtighed tilrådes derfor ved anvendelse hos kvinder, der har fået foretaget hysterektomi på grund af endometriose, navnlig hvis der er tilbageværende endometriose.
English: WHI studies combined - Additional risk of ischaemic stroke* over 5 years' use
Danish: WHI-studierne kombineret - forøgelse af risikoen for iskæmisk apopleksi* i løbet af 5 års brug
English: Using [invented name] together with latex products (e.g. condoms, diaphragms) can reduce the functionality of such products thereby making them less reliable as [invented name] contains excipients (other ingredients, particularly stearates).
Danish: Brug af [særnavn] sammen med latex-produkter (f.eks. kondom, pessar) kan nedsætte funktionen af latexproduktet og derved gøre det mindre pålideligt på grund af hjælpestofferne i [særnavn] (navnlig stearater).
English: Randomised controlled data found no increased risk of CAD in hysterectomised women using oestrogen-only therapy.
Danish: Randomiserede kontrollerede data viste ikke en forhøjet risiko for koronararteriesygdom hos hysterektomerede kvinder, der får østrogenbehandling alene.
English: The risk of haemorrhagic stroke is not increased during use of HRT.
Danish: Risikoen for hæmoragisk apopleksi er ikke forhøjet under hormonsubstitutionsbehandling.
English: Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer.
Danish: Langvarig (mindst 5-10 år) hormonsubstitutionsterapi med østrogen alene er blevet sat i forbindelse med en let øget risiko for ovariecancer.
English: During prolonged use, you should look out for possible systemic effects (affecting the whole body).
Danish: Under langvarig anvendelse skal du være opmærksom på eventuelle virkninger på hele kroppen.
English: − if you have skin diseases in the external genital area caused by bacterial, fungal or viral infections
Danish: − hvis du har bakterie-, svampe- eller virusbetingede sygdomme i de ydre kønsorganer
English: - Gall bladder disease - Various skin disorders: o discoloration of the skin especially of the face or neck known as “pregnancy patches (chloasma) o painful reddish skin nodules (erythema nodosum) o rash with target-shaped reddening or sores (erythema multiforme)
Danish: - galdeblæresygdom - forskellige hudlidelser: o misfarvning af huden, navnlig i ansigtet og på halsen (graviditetsmaske, kloasma) o smertefuld knudeformet rødme af huden (erythema nodosum) o udslæt med skydeskiveformet rødme eller sår (erythema multiforme)
English: If unexpected bleeding should occur, treatment with [invented name] must be suspended until the cause of bleeding has been clarified (see section 4.4 on endometrial safety).
Danish: Ved uventet blødning skal behandlingen med [særnavn] udsættes, indtil blødningsårsagen er udredt (se pkt.
English: There is no evidence from randomised controlled trials of protection against myocardial infarction in women with or without existing CAD who received combined oestrogenprogestagen or oestrogen-only.
Danish: Der er ingen evidens fra randomiserede kontrollerede studier for, at behandling med østrogen-gestagen eller med østrogen alene beskytter kvinder med eller uden eksisterende koronararteriesygdom mod myokardieinfarkt.
English: frequency cannot be estimated from the available data Uncommon: temporarily mild local irritation (e.g. itching, burning) and slight discharge may occur.
Danish: Ikke almindelig: forbigående let irritation i skeden (f.eks. kløe, brændende fornemmelse) og let udflåd kan forekomme.
English: Risk estimates have been drawn from systemic exposure and it is not known how these apply to local treatments.
Danish: De beregnede risici er udledt af systemisk eksponering, og det vides ikke, om de kan anvendes på lokal behandling.
English: [This section should have all of the following text only]
Danish: [Dette punkt skal og må kun indeholde hele den følgende tekst]
English: Cream [invented name] is used in women for the treatment of atrophic vulva disorders attributable to oestrogen deficiency and for Lichen sclerosus (long-term itchy skin signs) on external genitals.
Danish: Cremen [særnavn] anvendes hos kvinder til behandling af svindbetingede (atrofiske) lidelser på venusbjerget og langvarige hudgener med kløe (Lichen sclerosus) af de ydre kønsorganer.
English: Unopposed oestrogen stimulation may lead to premalignant transformation in the residual foci of endometriosis.
Danish: Stimulation med østrogen alene kan medføre præmalign omdannelse i tilbageværende foci med endometriose.
English: Section 4.8 Undesirable effects [The text below should be inserted in this section.
Danish: Punkt 4.8 Bivirkninger [Nedenstående tekst indsættes under dette punkt.
English: - Pregnancy
Danish: - graviditet
English: There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65.
Danish: WHI-studiet giver nogen evidens for en øget risiko for formodet demens hos kvinder, der efter 65 års-alderen påbegynder kontinuerlig hormonsubstitutionsterapi (kombineret eller med østrogen alene).
English: Breast cancer risk
Danish: Risiko for mammacancer
English: Vigilance is required for possible systemic effects.
Danish: Patienten bør overvåges for mulige systemiske virkninger.
English: During prolonged use, vigilance is required for possible systemic effects.
Danish: Under langvarig anvendelse bør patienten overvåges for mulige systemiske bivirkninger.
English: Therefore, prolonged treatment beyond 4 weeks is not recommended.
Danish: Derfor frarådes langvarig behandling ud over 4 uger.
English: Compare
Danish: Sammenligning
English: US WHI studies - additional risk of breast cancer after 5 years' use Age range (years)
Danish: WHI-studierne i USA - beregnet forøgelse af risikoen for mammacancer efter 5 års brug Alder (år)
English: Section 4.7 Effects on ability to drive and use machines [The text below should be inserted in this section and the existing text should be deleted]
Danish: Punkt 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner [Nedenstående tekst indsættes under dette punkt og erstatter den eksisterende tekst]
English: Incidence per 1000 women placebo arm over 5 years
Danish: Forekomst pr. 1.000 kvinder i placeboarmen i en 5-årig periode
English: Vaginitis including infection of the genitals caused by a fungus, changes in sexual drive, mood disturbances, dizziness, headache, migraine, anxiety, intolerance to contact lenses, blood clots in a vein (thrombosis), nausea, bloating, abdominal pain, hirsutism, pruritus, rash, oedema
Danish: Vaginitis (betændelse i skeden) (herunder svampeinfektion på kønsorganerne), ændret sexlyst, humørforstyrrelser, svimmelhed, hovedpine, migræne, angst, ubehag ved brug af kontaktlinser (intolerans), blodpropper i en vene (trombose), kvalme, oppustethed, mavesmerter, unormal behåring (hirsutisme), kløe, udslæt og væskeansamling (ødem)
English: For the initial short-term external treatment of acute, mild, inflamed, burning and itching skin diseases of the external female genital area for which weak acting corticosteroids and estradiol are indicated, in postmenopausal patients.
Danish: Initial kortvarig lokal behandling af akutte, lette hudsymptomer med inflammation, brænden og kløe i de ydre kønsorganer hos postmenopausale kvinder, hvor svagtvirkende kortikosteroider og estradiol er indiceret.
English: Additional cases per 1000 HRT user 5 years (95% CI)
Danish: Ekstra tilfælde pr. 1.000 brugere af 5 års hormonsubstitutions terapi (95 % CI)
English: Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis.
Danish: Stimulation med østrogen alene kan medføre præmalign eller malign omdannelse i tilbageværende foci med endometriose.
English: Section 4.3 Contraindications [The text below should be inserted by replacing the existing text of this section]
Danish: Punkt 4.3 Kontraindikationer [Nedenstående tekst indsættes som erstatning for den eksisterende tekst under dette punkt]
English: Arthralgias, leg cramps
Danish: Artralgi, benkramper
English: Depression, hair loss, joint pain, leg cramps, abnormal uterine bleeding, breast pain, breast tenderness, breast enlargement, breast discharge, weight increase or decrease, increased blood fats (triglycerides)
Danish: Depression, hårtab, ledsmerter, lægkramper, unormal blødning fra livmoderen, brystsmerter, ømhed i brysterne, brystforstørrelse, udflåd fra brysterne, vægtstigning eller vægttab, stigning i blodets indhold af fedtstoffer (triglycerider)
English: The occurrence of such an event is more likely in the first year of using HT (see section 4.4).
Danish: Sandsynligheden for sådanne hændelser er større i det første år med hormonsubstitutionsterapi end senere (se pkt.
English: Uncommon > 1/1000 to <1/100 (> 0.1% and
Danish: Ikke almindelig > 1/1.000 til <1/100 (> 0,1 % og
English: The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogen-progestagen and possibly also oestrogen-only HRT, that is dependent on the duration of taking HRT.
Danish: Den samlede evidens tyder på, at risikoen for mammacancer øges ved hormonsubstitutionsterapi med en kombination af østrogen og gestagen og muligvis også med østrogen alene, og at risikoen afhænger af behandlingsvarigheden.
English: see section 4.4) - Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) - Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal - Known hypersensitivity to the active substances or to any of the excipients - Porphyria.
Danish: - Aktiv eller nylig arteriel tromboembolisk sygdom (f.eks. angina, myokardieinfarkt) - Akut leversygdom eller leversygdom i anamnesen, så længe leverfunktionsprøver ikke er normaliseret - Overfølsomhed over for de aktive stoffer eller et eller flere af hjælpestofferne - Porfyri
English: See sction 4.2 and
Danish: 4.2 og 4.4.
English: In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.
Danish: Patienter med intakt uterus har øget risiko for endometriehyperplasi og -karcinom ved langvarig behandling med østrogener alene.
English: Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk.
Danish: Patienter med kendt trombofil tilstand kan have en øget risiko for venøs tromboemboli, og risikoen kan muligvis øges ved hormonsubstitutionsterapi.
English: The use of oestrogen-only and oestrogen + progestogen therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Danish: Behandling med østrogen alene og østrogen + gestagen er forbundet med en op til 1,5 gange forhøjet relativ risiko for iskæmisk apopleksi.
English: The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users than in nonusers, especially during the first year of taking it.
Danish: Der er en 1,3-3 gange højere risiko for blodpropper i venerne hos brugere af hormonerstatningsbehandling end hos ikke-brugere.
English: Do not use up any remaining content after completing treatment course.
Danish: Når dit behandlingsforløb er afsluttet, skal du ikke bruge eventuelt overskydende indhold.
English: - history of malignant oestrogen-dependent tumours - tumours of the womb (leiomyoma, uterine myoma).
Danish: - ved maligne østrogenafhængige tumorer i anamnesen - ved uterustumorer (leiomyom, uterusmyom)
English: However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT increase with age.
Danish: Baseline-risikoen for apopleksi er imidlertid stærkt aldersafhængig, hvorfor den totale risiko for apopleksi stiger med alderen hos kvinder i hormonsubstitutionsterapi.
English: [invented name] is used:
Danish: [særnavn] bruges:
English: Do not use [invented name] when you use other HRT products such as estrogen tablets, patches or gel for treatment of hot flushes or prevention of osteoporosis.
Danish: Brug ikke [særnavn], hvis du bruger andre præparater til hormonerstatning såsom østrogentabletter, østrogenplastre eller østrogengel til behandling af hedeture eller forebyggelse af knogleskørhed.
English: Maturation of the vaginal epithelium is dependent upon oestrogens.
Danish: Modning af epitelet i vagina er østrogenafhængig.
English: [The text below should be inserted by replacing the existing text in the relevant paragraph]
Danish: [Nedenstående tekst indsættes og erstatter den eksisterende tekst i det pågældende punkt]
English: Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer)
Danish: Fortykkelse af livmoderslimhinden (endometrie-hyperplasi) og livmoderkræft (endometriecancer)
English: It should be taken into account that these conditions may recur or be aggravated during oestrogen treatment, in particular:
Danish: Opmærksomheden henledes på, at østrogenbehandling kan medføre recidiv eller forværring af disse sygdomme: