FrancophonIA/ELRC3.0 huggingface dataset:
English: If so, you should see your doctor more often for check-up's.
Danish: I så fald skal du gå oftere til kontrol hos lægen.
English: Risk ratio and 95% CI
Danish: Risikoforhold og 95 % CI
English: Section 4.6 Fertility, Pregnancy and lactation
Danish: Punkt 4.6 Fertilitet, graviditet og amning
English: Treatment should not be restarted until the woman is completely mobilised.
Danish: Behandlingen bør først genoptages, når patienten er fuldstændigt mobiliseret.
English: You can start using [invented name] on any day which is best for you.
Danish: Du kan begynde at bruge [særnavn] på en hvilken som helst dag, der passer dig.
English: The geometric mean half-life of E2 was 5.05 hours, with high interindividual variability.
Danish: Estradiols geometriske middelhalveringstid var 5,05 timer med stor interindividuel variabilitet.
English: - Diabetes mellitus with or without vascular involvement
Danish: - diabetes mellitus med eller uden vaskulære skader
English: Changes in weight (increase or decrease), increased triglycerides
Danish: Vægtændring (stigning eller tab), forhøjede triglycerider
English: [In this section the use of the cream with the applicator is inserted.
Danish: [Under dette punkt indsættes anvendelsen af cremen med applikatoren.
English: [invented name] should not be used in the following cases:
Danish: [særnavn] bør ikke anvendes i følgende tilfælde:
English: - It belongs to a group of hormones called oestrogens.
Danish: - det tilhører en gruppe hormoner, der kaldes østrogener
English: The risk ratio is not constant but will increase with increasing duration of use
Danish: Risikoforholdet er ikke konstant, men stiger med
English: This happens naturally after the menopause.
Danish: Dette sker naturligt efter overgangsalderen.
English: Over 95% of estriol is excreted in the urine, mainly in the form of glucuronides.
Danish: Over 95 % af estriol udskilles i urinen, hovedsagelig som glukuronider.
English: Estradiol conversion to estriol is irreversible.
Danish: Omdannelsen af estradiol til estriol er irreversibel.
English: Free or biologically active hormone concentrations are unchanged.
Danish: Koncentrationen af frit (biologisk aktivt) hormon er uændret.
English: Heart disease (heart attack)
Danish: Hjertesygdomme (hjerteanfald)
English: After stopping treatment risk remain elevated for at least 10 years.
Danish: Efter behandlingsophør er risikoen fortsat forhøjet i mindst 10 år.
English: Conditions which need supervision
Danish: Sygdomme, der kræver supervision
English: In case the applicator is damaged you should not use it and inform the manufacturer.
Danish: Hvis applikatoren er beskadiget, må du ikke bruge den, og du bedes underrette fremstilleren.
English: The use of HRT carries risks which need to be considered when deciding whether to start taking [invented name], or whether to carry on taking it.
Danish: Hormonerstatningsbehandling medfører risici, der må tages i betragtning ved afgørelsen af, om du skal begynde at bruge [særnavn] eller skal blive ved med at bruge det.
English: If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
Danish: Hvis patienten har eller har haft nogen af følgende sygdomme, og/eller sygdommen tidligere er blevet forværret under graviditet eller hormonbehandling, bør patienten overvåges tæt.
English: The biological effect of 17β-estradiol is carried out through a number of specific oestrogen receptors.
Danish: Den biologiske virkning af 17β-estradiol medieres gennem en række specifikke østrogenreceptorer.
English: Therapy should be discontinued in case a contra-indication is discovered and in the following situations:
Danish: Behandlingen skal seponeres, hvis der konstateres en kontraindikation, samt i følgende situationer:
English: It is inserted into your vagina, so the hormone is released where it is needed.
Danish: Det indføres i skeden, så hormonet frigives, hvor der er brug for det.
English: $ When the analysis was restricte to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: after 5 years the risk was higher than non-users
Danish: $ Når analysen blev begrænset til kvinder, der ikke havde anvendt hormonsubstitutionsterapi inden undersøgelsen, sås ingen øget risiko i løbet af de første 5 års behandling; efter 5 år var risikoen højere end hos ikke-brugere
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Danish: T3-resinoptagelsen er nedsat, hvilket afspejler det forhøjede TBG.
English: This may relieve discomfort in the vagina.
Danish: Dette kan afhjælpe ubehag i skeden.
English: Route of administration: cream for vaginal use
Danish: Indgivelsesvej: creme til vaginal anvendelse
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Danish: Bilag III Ændringer af de relevante punkter af produktresuméerne og indlægssedlerne
English: The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.
Danish: Det aktive indholdsstof, syntetisk 17β-estradiol, er kemisk og biologisk identisk med endogent humant estradiol.
English: Any existing section should be deleted.]
Danish: Et eventuelt eksisterende punkt slettes.]
English: [The following text should be inserted after the section “Clean the applicator after use”]
Danish: [Nedenstående tekst indsættes efter punktet “Rengør applikatoren efter brug”]
English: The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment.
Danish: Den forhøjede risiko viser sig efter få års brug, men returnerer til baseline i løbet af få (højst fem) år efter behandlingsophør.
English: − You should only use [invented name] under medical supervision.
Danish: − Du må kun bruge [særnavn] under lægeligt opsyn.
English: Additional cases per 1000 users
Danish: Ekstra tilfælde pr. 1.000 brugere
English: The experience treating women older than 65 years is limited.
Danish: Der er begrænsede erfaringer med behandling af kvinder over 65 år.
English: Thus, prednisolone is particularly suitable for the treatment of inflammatory dermatoses in problem areas, as it has weak anti-inflammatory, antiallergic and antipruritic properties.
Danish: Prednisolon er derfor særligt egnet til behandling af inflammatoriske dermatoser i problemområder, da det har svag antiinflammatorisk, antiallergisk og antipruritisk virkning.
English: For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used.
Danish: Til påbegyndelse og vedligeholdelse af behandling hos postmenopausale symptomer bør den laveste effektive dosis anvendes i kortest mulig tid (se også pkt.
English: Before initiating or reinstituting hormone therapy, a complete personal and family medical history should be obtained.
Danish: Før initiering eller genoptagelse af hormonbehandling bør der optages en fuldstændig personlig og familiær anamnese.
English: Talk to a doctor or pharmacist.
Danish: Tal med lægen eller apotekspersonalet.
English: In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
Danish: I alle tilfælde skal risici og fordele vurderes nøje mindst én gang årligt, og hormonsubstitutionsterapi bør kun fortsætte, så længe fordelene overstiger risikoen.
English: Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
Danish: Bemærk: Baggrundsincidensen af mammacancer afhænger af det pågældende EU-land, og antallet af ekstra tilfælde af mammacancer vil øges proportionalt.
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Danish: Under behandlingen anbefales periodisk kontrol med en hyppighed og af en art, der er tilpasset den enkelte patient.
English: The following values were determined after single-dose administration of 2 g [invented name], equivalent to 200 µg E2: AUCδ0-∞ = 887.5 pg/ml*h; AUCδ0-tz = 799.5 pg/ml*h; Cδmax = 86.2 pg/ml.
Danish: Efter administration af en enkelt dosis på 2 g [særnavn], svarende til 200 µg estradiol, bestemtes følgende værdier: AUCδ0-∞ = 887,5 pg/ml∙h; AUCδ0-tz = 799,5 pg/ml∙h; Cδmax = 86,2 pg/ml.
English: - Migraine or (severe) headache
Danish: - migræne eller (svær) hovedpine
English: According to the current, standard classification system for topical corticosteroids, i.e. weak (I), moderately potent (II), potent (III) and very potent (IV), prednisolone - closely related to natural hydrocortisone (= cortisol) - belongs to the first group.
Danish: Ifølge den gældende standardklassificering af topiske kortikosteroider i svage (I), moderat potente (II), potente (III) og meget potente (IV) hører prednisolon - der er nært beslægtet med naturligt hydrocortison (= cortisol) - til den første gruppe.
English: Oestrogens maintain vaginal pH around normal range (4.5) which enhances normal bacterial flora.
Danish: Østrogener holder pH i vagina omkring normalområdet (4,5), hvilket fremmer den normale bakterieflora.
English: The changes to the relevant sections of the summary of product characteristics and package leaflet is the outcome of the referral procedure.
Danish: Ændringerne af de pågældende punkter i produktresuméet og indlægssedlen er resultatet af referralproceduren.
English: - dimpling of the skin - changes in the nipple - any lumps you can see or feel
Danish: - fordybninger i huden - forandringer i brystvorterne - enhver knude, der kan ses eller mærkes
English: Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death.
Danish: Blodpropper kan være alvorlige, og hvis en af dem vandrer til lungerne, kan det medføre smerter i brystet, stakåndethed, besvimelse eller endda død.
English: In another study, mean estradiol serum concentrations at baseline and at day 31 (i.e. about 36 h after administration of study medication on day 29) were 6.4 pg/ml and 15.1 pg/ml, respectively, in the [invented name] group and 4.4 pg/ml and 6.2 pg/ml, respectively, in the placebo group.
Danish: I et andet studie var den gennemsnitlige serumkoncentration af estradiol ved baseline og på dag 31 (dvs. ca. 36 timer efter administration af studiemedicinen på dag 29) henholdsvis 6,4 pg/ml og 15,1 pg/ml i [særnavn]-gruppen, og henholdsvis 4,4 pg/ml og 6,2 pg/ml i placebogruppen.
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1antitrypsin, ceruloplasmin).
Danish: Andre plasmaproteiner kan være forhøjede (angiotensinogen/renin-substrat, alfa-1antitrypsin, ceruloplasmin).
English: Endogenous 17β-estradiol induces and maintains the primary and secondary female sexual characteristics.
Danish: Endogent 17β-estradiol fremkalder og opretholder de primære og sekundære kvindelige kønskarakteristika.
English: The endometrial safety of prolonged treatment and repeated treatment courses is unknown.
Danish: Den endometrielle sikkerhed ved langvarig behandling eller gentagne behandlingsforløb er ukendt.
English: Changes in libido, mood disturbances
Danish: Ændret libido, humørforstyrrelser
English: - Leiomyoma (uterine fibroids) or endometriosis
Danish: - leiomyom (uterusfibrom) eller endometriose
English: The following categories are used to express the frequency of side effects: Very common: more than 1 in 10 patients treated Common:
Danish: Bivirkninger inddeles i følgende kategorier efter hyppighed: Meget almindelig: flere end 1 af hver 10 behandlede Almindelig:
English: Application beyond 4 weeks is not recommended, due to potential systemic exposure to estradiol during treatment.
Danish: Anvendelse i mere end 4 uger frarådes på grund af den potentielle systemiske eksponering for estradiol under behandlingen.
English: The results of most epidemiological studies to date relevant to inadvertent foetal exposure to oestrogens indicate no teratogenic or foetotoxic effect.
Danish: Resultaterne fra de fleste af de epidemiologiske studier, der er relevante med hensyn til utilsigtet føtal eksponering for østrogener, viser ingen teratogen eller føtotoksisk virkning.
English: Reasons for immediate withdrawal of therapy
Danish: Grunde til øjeblikkelig seponering
English: Part B. - 0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products
Danish: Del B. - lægemidler indeholdende 0,005 w/w % estradiol / 0,4 w/w% prednisolon
English: Nonclinical studies provided no additional data of relevance to clinical safety beyond those already included in other sections of the SmPC.
Danish: De ikke-kliniske studier frembragte ikke supplerende oplysninger med relevans for den kliniske sikkerhed udover dem, der er indeholdt i andre punkter af produktresuméet.
English: - Risk factors for thromboembolic disorders (see below)
Danish: - risikofaktorer for tromboemboliske sygdomme (se nedenfor)
English: Go for regular breast screening as recommended by your doctor.
Danish: Få brysterne undersøgt regelmæssigt som anbefalet af lægen.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: Du kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V*.
English: By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Ved at indberette bivirkninger kan du medvirke til at skaffe flere oplysninger om sikkerheden af dette lægemiddel.
English: Women should be advised what changes in their breasts should be reported to their doctor or nurse.
Danish: Patienterne skal informeres om at indberette forandringer i mammae til lægen eller sygeplejersken.
English: It is caused by a drop in the levels of oestrogen in your body.
Danish: Årsagen er et fald i indholdet af østrogen i kroppen.
English: Interactions of [invented name] with other medicinal products were not investigated.
Danish: Interaktioner mellem [særnavn] og andre lægemidler er ikke undersøgt.
English: The existing relevant text need to be modified accordingly]
Danish: Det kan være nødvendigt at ændre den pågældende eksisterende tekst i henhold hertil]
English: Intravaginal applicator may cause minor local trauma, especially in women with serious vaginal atrophy.
Danish: Den intravaginale applikator kan medføre mindre lokale traumer, navnlig hos patienter med svær vaginalatrofi.
English: - Estradiol is a female sex hormone.
Danish: - estradiol er et kvindeligt kønshormon
English: # Overal risk ratio.
Danish: # Totalt risikoforhold.
English: However, being a HRT product, the following need to be considered:
Danish: Da der er tale om et hormonsubstitutionspræparat, skal følgende imidlertid tages i betragtning:
English: Medical examination/follow-up
Danish: Objektiv undersøgelse/opfølgning
English: If you get breakthrough bleeding or spotting, it's usually nothing to worry about, but you should make an appointment to see your doctor.
Danish: Hvis du får gennembrudsblødning eller pletblødning, er det normalt ikke noget at bekymre sig om, men du skal dog få en tid hos lægen.
English: Post-marketing experience The following undesirable effects related to [invented name] have been reported:
Danish: Erfaringer efter markedsføring Der er indberettet følgende bivirkninger for [særnavn]:
English: If you use too much [invented name] on one occasion, side effects such as nausea may occur.
Danish: Hvis du bruger for meget [særnavn] en enkelt gang, kan der komme bivirkninger såsom kvalme.
English: Results of the WHI studies are presented:
Danish: Resultaterne af WHI-studierne:
English: [invented name] is unlikely to have any effect on alertness or coordination.
Danish: [særnavn] forventes ikke at påvirke årvågenhed eller koordinationsevne.
English: It is not known how these risks apply to locally administered treatments such as [invented name] .
Danish: Det vides ikke, om de samme risici er knyttet til lægemidler, der påføres lokalt, såsom [særnavn].
English: If your vaginal skin is very vulnerable, be careful when inserting the applicator into the vagina.
Danish: Er slimhinden i din skede meget sart, skal du være forsigtig, når du fører applikatoren ind i skeden.
English: If you notice signs of a blood clot, such as:
Danish: hvis du bliver gravid hvis du bemærker tegn på en blodprop, såsom:
English: If any of the above conditions appear for the first time while using [invented name] , stop using it at once and consult your doctor immediately.
Danish: Hvis nogen af ovennævnte sygdomme viser sig for første gang, mens du bruger [særnavn], skal du straks holde op med at bruge det og kontakte lægen.
English: Investigations including appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Danish: Der bør anvendes passende billeddiagnostiske værktøjer, f.eks. mammografi, i henhold til anerkendt screeningspraksis, modificeret efter de individuelle kliniske behov.
English: - Probable dementia over the age of 65 (see section 4.4)
Danish: - formodet demens ved alder over 65 (se pkt.
English: Patients should be told to contact their doctors immediately when they are aware of a potential thromboembolic symptom (e.g. painful swelling of a leg, sudden pain in the chest, dyspnoea).
Danish: Patienten skal informeres om øjeblikkeligt at kontakte læge, hvis patienten opdager et eventuelt tromboembolisk symptom (f.eks. smertefuldt hævelse af et ben, pludselige smerter i brystet, dyspnø).
English: Ovarian cancer is rare.
Danish: Æggestokkræft er sjælden.
English: Clinically, an increased metabolism of oestrogens may lead to decreased effect and changes in the uterine bleeding profile.
Danish: Klinisk kan øget metabolisering af østrogener medføre nedsat virkning og ændring i den uterine blødningsprofil.
English: […] and cutaneous use in the external genital area.
Danish: […] og kutan anvendelse på de ydre kønsorganer.
English: There is no consensus about the possible role of varicose veins in VTE.
Danish: Der er ikke konsensus om den mulige rolle af varicer på venøs tromboemboli.
English: Take special care with [invented name] Tell your doctor if you have or have ever had any of the following problems before you start the treatment.
Danish: Vær ekstra forsigtig med at bruge [særnavn] Før du begynder på behandlingen, skal du fortælle lægen, hvis du har eller nogensinde har haft nogen af følgende problemer.
English: - Asthma
Danish: - astma
English: - Skin and subcutaneous disorders: erythema multiforme, erythema nodosum, vascular purpura
Danish: - hud og subkutane væv: erythema multiforme, erythema nodosum, vaskulær purpura
English: Blood clots in a vein (thrombosis)
Danish: Blodpropper i en vene (trombose)
English: * WHI study in women with no uterus, which did not show an increase in risk of breast cancer.
Danish: * WHI-studie hos kvinder uden uterus, hvor der ikke påvistes en øget risiko for mammacancer.
English: Endometrial safety of long-term (more than one year) or repeated use of local vaginally administered oestrogen is uncertain.
Danish: Den endometrielle sikkerhed af langvarig (over et år) eller gentagen anvendelse af vaginalt administreret østrogen er uafklaret.
English: Medical history and regular check-ups
Danish: Sygdomshistorie og regelmæssig kontrol
English: If pregnancy occurs during medication with [invented name], treatment should be withdrawn immediately.
Danish: Hvis graviditet indtræder under brug af [særnavn], skal behandlingen straks seponeres.
English: The following information applies, unless you have been prescribed [invented name] otherwise by your doctor.
Danish: Følgende oplysninger gælder, medmindre lægen har givet andre anvisninger, da du fik ordineret [særnavn].
English: Therapeutic indications (areas of use):
Danish: Terapeutiske indikationer (hvad det anvendes til):
English: There is no evidence that HRT will prevent a heart attack.
Danish: Der er ingen beviser for, at hormonerstatningsbehandling forebygger hjerteanfald.
English: Oestrogens increase the number of superficial and intermediate cells and decrease the number of basal cells in vaginal smear.
Danish: Østrogener øger antallet af superficielle og intermediære celler og nedsætter antallet af basalceller i et smear.
English: Usually, it's nothing to worry about, but you should make an appointment to see your doctor.
Danish: Normalt er det ikke noget at bekymre sig om, men få alligevel en tid hos lægen.
English: For more information about these side effects, see Section 2
Danish: Du kan se mere om disse bivirkninger under punkt 2.
English: Like all medicines, [invented name] can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: [invented name] works by replacing the oestrogen which is normally produced in the ovaries of women.
Danish: [særnavn] virker ved at erstatte det østrogen, der normalt produceres i æggestokkene.
English: The steroid receptor complex is bound to the cells' DNA and induces synthesis of specific proteins.
Danish: Steroid-receptorkomplekset bindes til cellernes DNA og inducerer syntesen af specifikke proteiner.
English: If prolonged immobilisation is to follow elective surgery, temporarily stopping HRT 4 to 6 weeks earlier is recommended.
Danish: Ved langvarig immobilisering efter elektive kirurgiske indgreb anbefales midlertidig seponering af hormonsubstitutionsbehandling 4-6 uger forinden.
English: [invented name] should be applied with an applicator.
Danish: [særnavn] skal påføres med en applikator.
English: HRT does not improve cognitive function.
Danish: Hormonsubstitutionsterapi forbedrer ikke den kognitive funktion.
English: Therefore, for safety reasons, you should use [invented name] no longer than 4 weeks.
Danish: Af sikkerhedsmæssige årsager skal du derfor ikke bruge [særnavn] længere end 4 uger.
English: One filled applicator dose (= 2 g cream) is inserted before retiring to bed.
Danish: En dosis = en fyldt applikator (= 2 g creme) indføres før sengetid.
English: As in all postoperative patients, prophylactic measures need to be considered to prevent VTE following surgery.
Danish: Som hos alle postoperative patienter må VTE-profylakse overvejes efter operationer.
English: If you become pregnant, stop using [invented name] and contact your doctor.
Danish: Hvis du bliver gravid, skal du holde op med at bruge [særnavn] og kontakte lægen.
English: [Invented name] should not be used in patients who are treated with systemic Hormone Replacement Therapy (HRT).
Danish: [særnavn] bør ikke anvendes hos patienter i systemisk hormonsubstitutionsterapi (HRT).
English: Estradiol is the most potent natural oestrogen to act intracellularly.
Danish: Estradiol er det mest potente naturlige østrogen og virker intracellulært.
English: Given that systemic exposure occurs during treatment with [Invented name], prolonged treatment beyond 4 week is not recommended.
Danish: På grund af systemisk eksponering under behandlingen med [særnavn] frarådes langvarig behandling ud over 4 uger.
English: - Epilepsy
Danish: - epilepsi
English: Especially prolonged use (>4 weeks) is therefore not recommended.
Danish: Derfor frarådes især langvarig behandling (>4 uger).
English: Always use [invented name] exactly according to the instructions given in this leaflet.
Danish: Brug altid [særnavn] nøjagtigt som beskrevet i denne indlægsseddel.
English: Ovarian cancer is much rarer than breast cancer.
Danish: Ovariecancer er langt sjældnere end mammacancer.
English: If you notice any of the following when using HRT: - Migraine-like headaches which happen for the first time - Yellowing of your skin or the whites of your eyes (jaundice).
Danish: hvis du bemærker noget af følgende: - migrænelignende hovedpine, der optræder for første gang - gulfarvning af huden eller det hvide af øjnene (gulsot).