FrancophonIA/ELRC3.0 huggingface dataset:
English: [invented name] should not be used immediately prior to sexual intercourse or as a lubricant.
Danish: [særnavn] bør ikke anvendes umiddelbart før coitus eller som smøremiddel.
English: HRT is associated with a 1.3-3 fold increased relative risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Danish: Hormonsubstitutionsterapi er forbundet med en 1,3-3 gange forhøjet relativ risiko for venøs tromboemboli (VTE), dvs. dyb venetrombose eller lungeemboli.
English: Women aged 50 to 79 who are not taking HRT, on average, 9 to 14 in 1000 will be diagnosed with breast cancer over a 5-year period.
Danish: Gennemsnitligt 9-14 ud af 1.000 kvinder i alderen 50-79 år, der ikke får hormonerstatningsbehandling, vil få stillet diagnosen brystkræft i løbet af en 5-års periode.
English: For the treatment of atrophic disorders of the vagina and vulva, which are due to a lack of oestrogen, e.g. atrophic vaginitis, coital problems, vaginal stenosis (narrowing), vulvar atrophy with burning and itching
Danish: Til behandling af svindbetingede (atrofiske) lidelser af skeden og venusbjerget, f.eks. skedekatar (atrofisk vaginitis), samlejeproblemer, forsnævring af skeden (vaginal stenose) og svind af venusbjerget (vulvær atrofi) med brænden og kløe.
English: In prolonged use (beyond 4 weeks), you should look out for possible systemic side effects (e.g. chest pain) and skin atrophy.
Danish: Ved langvarig anvendelse skal du være på vagt over for eventuelle virkninger på hele kroppen (f.eks. smerter i brystet) og tynd hud (hudatrofi).
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Alopeci
English: During treatment with [invented name], after each application there is a transient increase in plasma estradiol levels above the physiological range of postmenopausal women.
Danish: Under behandlingen med [særnavn] medfører hver applikation en forbigående stigning i plasma-estradiol til et niveau over det fysiologiske interval hos postmenopausale kvinder.
English: HRT is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Danish: Hormonsubstitutionsterapi er forbundet med en 1,3-3 gange forhøjet risiko for at udvikle venøs tromboemboli (VTE), dvs. dyb venetrombose eller lungeemboli.
English: Lactation
Danish: Pletblødning
English: The WHI trial found no increase in risk of breast cancer in hysterectomised women using oestrogen-only HRT.
Danish: WHI-studiet fandt ikke en øget risiko for mammacancer hos hysterektomerede kvinder i hormonsubstitutionsterapi med østrogen alene.
English: Section 4.9 Overdose
Danish: Punkt 4.9
English: Combined oestrogen-progestagen and oestrogen-only therapy are associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Danish: Behandling med østrogen-gestagen og med østrogen alene er forbundet med en op til 1,5 gange forhøjet risiko for iskæmisk apopleksi.
English: As a precaution, [invented name] may not be used in children or adolescents.
Danish: Af sikkerhedsmæssige årsager må [særnavn] ikke anvendes hos børn eller unge.
English: [Invented name] should not be used during breastfeeding.
Danish: [særnavn] bør ikke anvendes under amning.
English: - known or suspected benign or malignant oestrogen-dependent tumours e.g. uterine leiomyoma, endometrial cancer) - history of malignant oestrogen-dependent tumours - Unspecified genital bleeding - Untreated endometrial hyperplasia - Skin diseases in the external genital area caused by bacterial, fungal, or viral infections
Danish: - Overfølsomhed over for estradiol, prednisolon, cetylstearylalkohol eller nogen af hjælpestofferne i [særnavn] - diagnosticeret eller formodet benign eller malign østrogenafhængig tumor (f.eks. uterint leiomyom, endometriecancer) - maligne østrogenafhængige tumorer i anamnesen - uspecificeret genitalblødning - ubehandlet endometriehyperplasi - hudsygdomme i de ydre kønsorganer forårsaget af bakterie-, svampe- eller virusinfektioner
English: [The text below should be inserted in this section.
Danish: [Nedenstående tekst indsættes under dette punkt.
English: - New onset of migraine-type headache
Danish: - nyindsættende migrænelignende hovedpine
English: [The text below should be deleted]
Danish: [Nedenstående tekst slettes]
English: Section 4.2 Posology and method of administration [The text below should be inserted by replacing the existing text of this section]
Danish: Punkt 4.2 Dosering og administration [Nedenstående tekst indsættes som erstatning for den eksisterende tekst under dette punkt]
English: Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1000 will be diagnosed with ovarian cancer over a 5-year period.
Danish: Gennemsnitligt 2 ud af 1 000 kvinder i alderen 50-69 år, der ikke får hormonerstatningsbehandling, vil få stillet diagnosen æggestokkræft i løbet af en 5-års periode.
English: [All current text in this section should be deleted and replaced by the text below]
Danish: [Hele den nuværende tekst under dette punkt slettes og erstattes af nedenstående tekst]
English: Undesirable effects - such as gastrointestinal complaints, nausea, etc - may occur after accidental or intentional administration of large amounts of [invented name].
Danish: Accidentel eller tilsigtet administration af store mængder af [særnavn] kan medføre bivirkninger såsom gastrointestinale gener, kvalme osv.
English: Hypersensitivity skin reaction (allergic contact eczema)
Danish: Allergisk hudreaktion (kontakteksem)
English: − if you have an benign or malignant tumour which is sensitive to oestrogens, such as fibroids inside your womb or uterine or cancer of the womb lining, or if you are suspected of having one
Danish: − hvis du har en østrogenfølsom godartet eller ondartet svulst såsom fibromer (knuder)
English: For women aged 50 to 79 who are taking oestrogenprogestagen HRT over 5 years, there will be 13 to 20 cases in 1000 users (i.e. an extra 4 to 6 cases).
Danish: Der vil være 13-20 tilfælde for hver 1.000 kvinder i alderen 50-79 år, som i 5 år får hormonerstatningsbehandling med østrogen-gestagen (dvs. 4-6 tilfælde ekstra).
English: [Invented name] is for use in postmenopausal women only.
Danish: Graviditet og amning [særnavn] er kun til brug hos kvinder efter overgangsalderen.
English: Risk estimates have been drawn from systemic exposure (HRT) and it is not known how these apply to local treatment.
Danish: Risikoestimaterne er beregnet på baggrund af systemisk eksponering (hormonsubstitutionsterapi), og det vides ikke, i hvilket omfang de gælder for lokalbehandling.
English: less than 1 in 10,000 patients treated
Danish: 1 til 10 patienter af hver 10.000 behandlede Meget sjælden: færre end 1 af hver 10.000 behandlede patienter Ikke kendt:
English: Do not use [invented name] immediately before sexual intercourse or as a lubricant, to prevent possible side effects in your partner.
Danish: Brug ikke [særnavn] umiddelbart før samleje eller som smøremiddel, da det kan give bivirkninger hos din partner.
English: - you are unable to walk for a long time because of major surgery, injury or illness - you are seriously overweight (BMI >30 kg/m - you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots - if any of your close relatives has ever had a blood clot in the leg, lung or another organ - you have systemic lupus erythematosus (SLE) - you have cancer.
Danish: - du er forhindret i at gå i længere tid på grund af en større operation, tilskadekomst eller sygdom - du er svært overvægtig (BMI >30 kg/m2) - du er tilbøjelig til at danne blodpropper og er derfor i langvarig behandling med medicin til forebyggelse af blodpropper
English: − if you have an untreated endometrial hyperplasia (i.e. thickening of the lining of the womb)
Danish: − hvis du har ubehandlet fortykkelse af livmoderslimhinden (endometrie-hyperplasi)
English: The relationship between pre-existing hypertriglyceridaemia and low dose local vaginal oestrogen therapy is unknown.
Danish: Det vides ikke, om der er en sammenhæng mellem præeksisterende hypertriglyceridæmi og vaginal behandling med lavdosisøstrogen.
English: CEE oestrogen-only CEE+MPA oestrogen & progestogen
Danish: Østrogen + gestagen som konjugeret østrogen + medroxyprogesteronacetat
English: − if you have any unexplained vaginal bleedings
Danish: − hvis du bløder fra skeden af ukendt årsag
English: [invented name] should not be used in the following cases: - Known, past or suspected breast cancer - Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer) - Undiagnosed genital bleeding - Untreated endometrial hyperplasia - Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) - Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency,
Danish: endometriecancer) - Ikke-diagnosticeret genitalblødning - Ubehandlet endometriehyperplasi - Tidligere eller nuværende tromboemboli (dyb venetrombose, lungeemboli) - Trombofile lidelser (f.eks. mangel på protein C, protein S eller antitrombin, se pkt.
English: [The text below should be inserted in this section.]
Danish: [Nedenstående tekst indsættes under dette punkt.]
English: Abnormal uterine bleeding (breakthrough bleeding/spotting), breast pain, breast tenderness, breast enlargement, breast discharge, leukorrhoea
Danish: Unormal uterin blødning (gennembrudsblødning/pletbl ødning), smerter i mammae, ømhed i mammae, forstørrede mammae, udflåd fra mammae, leukorré
English: - An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestogen therapy for more than 5 years.
Danish: - For kvinder, der får kombineret østrogen-gestagen behandling i mere end fem år, angives op til en fordobling af risikoen for at få stillet diagnosen mammacancer.
English: [The text below should be all deleted from this section]
Danish: [Hele nedenstående tekst slettes fra dette punkt]
English: - Growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia) - A disease affecting the eardrum and hearing (otosclerosis) - A disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE) - Increased risk of getting an oestrogen-sensitive cancer (such as having a mother,
Danish: - Forekomst og vækst af livmoderslimhinde uden for livmoderen (endometriose) eller fortykkelse af livmoderslimhinden (endometrie-hyperplasi) - Otosklerose, en sygdom, der rammer trommehinden og giver nedsat hørelse - Systemisk lupus erythematosus, en immunsygdom, der berører mange organer - Øget risiko for en østrogenfølsom kræfttype (f.eks. hvis din mor, søster eller bedstemor har haft brystkræft) - Øget risiko for en blodprop (se “Blodpropper i en vene (trombose)”) - Knuder i livmoderen (fibromer) - Meget højt indhold af fedtstoffer (triglycerider) i blodet - Væskeophobning som følge af hjerte- og eller nyreproblemer.
English: [The text below should be inserted in this section and the existing text should be deleted]
Danish: [Nedenstående tekst indsættes under dette punkt, og den eksisterende tekst slettes]
English: [The currently existing text should be deleted from this section and be replaced by the text below.]
Danish: [Den nuværende tekst under dette punkt slettes og erstattes af nedenstående tekst.]
English: HRT and cancer
Danish: Hormonerstatningsbehandling og kræft
English: The following side effects can occur with oral and/or transdermal oestrogen treatment:
Danish: Følgende bivirkninger kan forekomme ved østrogenbehandling med tabletter eller plastre:
English: Long-term use of oestrogen-only and combined oestrogen-progestogen HRT has been associated with a slightly increased risk of ovarian cancer.
Danish: Langvarig hormonsubstitutionsterapi med østrogen alene eller med kombineret østrogengestagen er forbundet med en let øget risiko for ovariecancer.
English: During treatment with [invented name], after each application there is an increase in plasma oestradiol levels above the physiological range of postmenopausal women.
Danish: Efter hver administration af [særnavn] ses en stigning i plasma-estradiol til et niveau over det fysiologiske postmenopausale interval.
English: Transient, mild skin irritation (e.g. burning, erythema).
Danish: Forbigående let hudirritation (f.eks. brændende fornemmelse, erytem)
English: [The wording of the indication should be deleted and the text below should be inserted in its place]
Danish: [Ordlyden af indikationen slettes og erstattes af nedenstående tekst]
English: − if you are known to be allergic (hypersensitive) to oestradiol, prednisolone, cetyl stearyl alcohol or any of the other ingredients of [invented name]
Danish: − hvis du ved, at du er overfølsom (allergisk) over for estradiol, prednisolon,
English: Ovarian cancer
Danish: Æggestokkræft
English: - A history of endometrial hyperplasia (see below)
Danish: - endometriehyperplasi i anamnesen (se nedenfor)
English: A relationship between ovarian cancer risk and local vaginal oestrogen therapy is uncertain.
Danish: Det er usikkert, om der er sammenhæng mellem risikoen for ovariecancer og lokal vaginal østrogenbehandling.
English: [invented name] is a cream for vaginal use.
Danish: [særnavn] er en creme til brug i skeden.
English: 1 to 10 patients treated out of 100
Danish: 1 til 10 patienter af hver 100 behandlede Ikke almindelig: 1 til 10 patienter af hver 1.000 behandlede Sjælden:
English: Million Women Study - Estimated additional risk of breast cancer after 5 years' use Age range (years) Additional cases per 1000 users of HRT over 5 year period*
Danish: Million Women Study - beregnet forøgelse af risikoen for mammacancer efter 5 års brug Alder (år)
English: Inform your doctor if any of these situations applies to you:
Danish: Sig det til lægen, hvis:
English: - Gallbladder disease
Danish: - galdeblæresygdom
English: For women in their 50s who have been taking oestrogen-progestagen HRT for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. 5 extra cases) For women in their 50s who have had their womb removed and have been taking oestrogenonly HRT for over 5 years, there will be 5 to 8 cases in 1000 users (i.e. 1 extra case).
Danish: Der vil være 5-8 tilfælde for hver 1 000 kvinder i 50'erne, som har fået fjernet livmoderen og i over 5 år har fået hormonerstatningsbehandling med østrogen alene (dvs. 1 ekstra tilfælde).
English: Oestrogen only HRT
Danish: Konjugeret østrogen alene
English: Section 6.5 Nature and contents of container [The text below should be deleted from this section]
Danish: Emballagetype og pakningsstørrelser [Nedenstående tekst slettes fra dette punkt]
English: Using other medicines
Danish: Andre sygdomstilstande
English: Note
Danish: Bemærk
English: [invented name] belongs to a group of medicines called local Hormone Replacement Therapy (HRT).
Danish: - det er nøjagtigt magen til det estradiol, der produceres af kvinders æggestokke [særnavn] tilhører gruppen af lægemidler til hormonerstatning, der anvendes lokalt.
English: It is uncertain whether long term (more than one year) or repeated use of local vaginally administered oestrogen products possess a similar risk.
Danish: Det vides ikke, om der er samme risiko ved lokal brug af østrogen i skeden gennem længere tid (mere end et år) eller gentagne gange.
English: [The text below should be deleted from this section]
Danish: [Nedenstående tekst slettes fra dette punkt]
English: - Asthma - Epilepsy - Diabetes - Gallstones - High blood pressure - Migraines or severe headaches - A liver disorder, such as a benign liver tumour
Danish: Der er derfor kun en lille risiko for forværring eller tilbagevenden af følgende sygdomme under behandlingen med [særnavn]: - Astma - Epilepsi - Sukkersyge - Galdesten - For højt blodtryk - Migræne eller svær hovedpine - Leversygdomme såsom en godartet leversvulst
English: Before you use [invented name]
Danish: Det skal du vide, før du begynder at bruge [særnavn]
English: Risk ratio
Danish: Risikoforhold
English: A relationship between ischaemic stroke and low dose local vaginal oestrogen therapy is uncertain.
Danish: Det er usikkert, om der er en sammenhæng mellem iskæmisk apopleksi og vaginal behandling med lavdosisøstrogen.
English: Evidence suggests that taking combined oestrogen-progestagen and possibly also oestrogenonly HRT increases the risk of breast cancer.
Danish: Hormonerstatningsbehandling i længere tid med tabletter, som kun indeholder østrogen, kan øge risikoen for livmoderkræft.
English: [The text below should be inserted]
Danish: [Nedenstående tekst indsættes]
English: A relationship between breast cancer risk and local vaginal oestrogen therapy is uncertain.
Danish: Det er usikkert, om der er en sammenhæng mellem lokal vaginal østrogenbehandling og risikoen for mammacancer.
English: [The text below should be inserted in this section]
Danish: [Nedenstående tekst indsættes under dette punkt]
English: Section 5.3 Preclinical safety data
Danish: Prækliniske sikkerhedsdata
English: Taking oestrogen-only HRT tablets for a long time can increase the risk of developing cancer of the womb lining (the endometrium).
Danish: Ved langvarig behandling med østrogener alene har patienter med intakt uterus en øget risiko for endometriehyperplasi og -karcinom.
English: Herbal preparations containing St John's Wort (Hypericum Perforatum) may induce the metabolism of oestrogens.
Danish: Naturlægemidler indeholdende perikon kan inducere metaboliseringen af østrogener.
English: Spotting
Danish: Amning
English: If you use more [invented name] than you should
Danish: Hvis du har brugt for meget [særnavn]
English: For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. 3 extra cases).
Danish: Gennemsnitligt 8 ud af 1.000 kvinder i 50'erne, der ikke får hormonerstatningsbehandling, forventes at få et slagtilfælde i løbet af en 5-års periode, mens der vil være 11 tilfælde blandt 1.000 kvinder i 50'erne, som får hormonerstatningsbehandling (dvs. 3 ekstra tilfælde).
English: WHAT [invented name] IS AND WHAT IT IS USED FOR [invented name] is a medicine that contains oestradiol and prednisolone.
Danish: cetylstearylalkohol eller nogen af de andre indholdsstoffer i [særnavn].
English: For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1000 users (i.e. up to 1 extra case).
Danish: Der vil være 13-20 tilfælde for hver 1 000 kvinder, der har fået hormonerstatningsbehandling i 5 år (dvs. 1 ekstra tilfælde).
English: Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
Danish: 4-7 ud af 1.000 kvinder i 50'erne, der ikke får hormonerstatningsbehandling, vil få en blodprop i en vene i løbet af en 5-års periode.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver alvorlig, eller hvis du får bivirkninger, der ikke er nævnt her.
English: A relationship between venous thromboembolism and local vaginal oestrogen therapy is uncertain.
Danish: Det er usikkert, om der er sammenhæng mellem lokal vaginal østrogenbehandling og risikoen for venøs tromboemboli.
English: (≥1/1,000 to <1/100)
Danish: Ikke almindelig (≥1/1 000 til <1/100)
English: Its use beyond 4 weeks is not recommended.
Danish: Langvarig behandling ud over 4 uger frarådes.
English: How to use [invented name]
Danish: SÅDAN SKAL DU BRUGE [særnavn]
English: HOW TO USE [invented name]
Danish: Sådan skal du bruge [særnavn]
English: 05 March 2014
Danish: Den 5. marts 2014
English: The European Commission issued a decision on 05 March 2014.
Danish: Europa-Kommissionen traf en beslutning den 5. marts 2014.
English: However, the Member States were not able to reach an agreement and the Spanish medicines regulatory agency referred the matter to the CHMP for arbitration on 31 October 2013.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den spanske lægemiddelstyrelse indbragte sagen for CHMP med henblik på voldgift den 31. oktober 2013.
English: This means that storage conditions could potentially have been inadequate leading to the degradation of the active substance, making the samples inadequate for testing.
Danish: Det betyder, at opbevaringsbetingelserne kan have været utilstrækkelige, hvilket kan have medført nedbrydning af det aktive stof, så prøverne var uegnede til testning.
English: Tibolone is a type of hormone replacement therapy (HRT) and is used to alleviate the symptoms of the menopause (such as hot flushes) in women who have not had a natural period for at least 12 months.
Danish: Tibolon er en form for hormonerstatningsbehandling og anvendes til at mildne symptomerne på overgangsalderen (såsom hedeture) hos kvinder, der ikke har haft en naturlig menstruation i mindst 12 måneder.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Spain) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Belgium, Germany and the Netherlands).
Danish: Ved denne procedure vurderer én medlemsstat (“referencemedlemsstaten”, her Spanien) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de “berørte medlemsstater”, her Belgien, Tyskland og Nederlandene).
English: On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicines Tibolona Aristo and Tibocina.
Danish: Den 19. december 2013 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlerne Tibolona Aristo og Tibocina.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicinal product has been shown.
Danish: Efter vurdering af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at der var påvist bioækvivalens med referencelægemidlet.
English: The company had supplied additional evidence to indicate that the study samples had been stored and maintained under adequate temperature conditions, further supported by the concentrations recorded in the bioequivalence study.
Danish: Virksomheden havde indsendt supplerende dokumentation, der viste, at prøverne i undersøgelsen var blevet opbevaret under passende temperaturforhold, hvilket yderligere støttedes af de koncentrationer, der var målt i bioækvivalensundersøgelsen.
English: Germany considered that these data were not reliable because of failings in the way the study samples were identified and registered and the cold storage and transport of the samples were recorded.
Danish: Tyskland fandt her, at dokumentationen ikke var pålidelig på grund af mangler i den måde, prøverne i undersøgelsen blev identificeret og registreret på, og den måde, prøvernes opbevaring i køleskab og transport blev registreret på.
English: Tibolona Aristo and Tibocina are medicines that contain the active substance tibolone; they are available as tablets (2.5 mg).
Danish: Tibolona Aristo og Tibocina er lægemidler, der indeholder det aktive stof tibolon; de fås som tabletter (2,5 mg).
English: What are Tibolona Aristo and Tibocina?
Danish: Hvad er Tibolona Aristo og Tibocina?
English: The CHMP therefore concluded that the benefits of Tibolona Aristo and Tibocina outweigh their risks and recommended that the marketing authorisations be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Tibolona Aristo og Tibocina overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelser i de berørte medlemsstater.