FrancophonIA/ELRC3.0 huggingface dataset:
English: • Intrarosa may weaken condoms, diaphragms and cervical caps made of latex.
Danish: • Intrarosa kan svække virkningen af kondomer og pessarer (vaginalpessarer/cervixpessarer), der er lavet af latex.
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 radioimmunoassay) or T3 levels (by radio-immunoassay).
Danish: • Østrogener øger tyroksinbindende globulin (TBG) med deraf følgende stigning i totalt cirkulerende thyroideahormon (målt ved proteinbundet jod), T4 (målt ved kolonne- eller radioimmunanalyse) eller T3 (målt ved radioimmunanalyse).
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: Ovarian cancer is much rarer than breast cancer.
Danish: Ovariecancer forekommer langt sjældnere end brystcancer.
English: In a study conducted in postmenopausal women, administration of the Intrarosa pessary once daily for 7 days resulted in a mean prasterone Cmax and area under the curve from 0 to 24 hours (AUC0-24) at day 7 of 4.4 ng/mL and 56.2 ng h/mL, respectively, which were significantly higher than those in the group treated with placebo (Table 3; Figure 1).
Danish: I en undersøgelse af postmenopausale kvinder resulterede administration af et Intrarosa-vagitorie én gang dagligt i 7 dage i et gennemsnitligt Cmax for prasteron og et gennemsnitligt areal under kurven fra 0-24 timer (AUC0-24) på dag 7 på hhv. 4,4 ng/ml og 56,2 ng.h/ml, hvilket er signifikant højere end i placebogruppen (tabel 3; figur 1).
English: Figure 1: Serum Concentrations of Prasterone (A), Testosterone (B), and Estradiol (C) Measured Over a 24h Period on Day 7 Following Daily Administration of Placebo or Intrarosa (mean ± S.D.)
Danish: Figur 1: Serumkoncentrationer af prasteron (A), testosteron (B) og østradiol (C) målt over en 24timers periode på dag 7 efter daglig administration af placebo eller Intrarosa (gennemsnit ± SD)
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: Hvis der konstateres en trombofil defekt, der korrelerer med trombosefund i familieanamnesen, eller hvis der konstateres en svær defekt (f.eks. mangel på antitrombin, protein S eller protein C eller en kombination heraf), er HRT kontraindiceret.
English: These risks apply less to vaginally administered oestrogen treatments:
Danish: Risikoen er ikke lige så stor ved vaginale østrogenbehandlinger:
English: • If VTE develops after initiating therapy, the drug should be discontinued.
Danish: • Hvis der opstår venøs tromboemboli efter igangsættelse af behandlingen, bør lægemidlet seponeres.
English: Stop taking Intrarosa and see a doctor immediately
Danish: Du skal holde op med at tage Intrarosa og straks kontakte lægen,
English: • If 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);
Danish: • Hvis du har eller tidligere har haft en blodprop i en vene (trombose), f.eks. i benene (dyb venetrombose) eller i lungerne (lungeemboli).
English: • Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestagen combinations.
Danish: • For brugere af østrogener alene er den mulige forøgelse af risikoen væsentligt mindre end for brugere af østrogen/progestagenkombinationer.
English: Intrarosa does not stimulate the endometrium as shown by atrophy of the lining of the womb in all women treated with Intrarosa for one year during the clinical trials.
Danish: Intrarosa stimulerer ikke livmoderslimhinden, hvilket er påvist ved atrofi (svind) i livmoderslimhinden hos alle de kvinder, der blev behandlet med Intrarosa i et år i de kliniske undersøgelser.
English: White to off-white, bullet-shaped pessary approximately 28 mm long and 9 mm in diameter at its widest end.
Danish: Hvidt til offwhite projektilformet vagitorie med en længde på ca. 28 mm og en diameter på ca. 9 mm i den brede ende.
English: Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
Danish: Intrarosa er indiceret til behandling af vulvær og vaginal atrofi hos postmenopausale kvinder med moderate til svære symptomer.
English: • Undiagnosed genital bleeding;
Danish: • Udiagnosticeret genitalblødning.
English: In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk following discussions with their doctor.
Danish: Der bør under alle omstændigheder ske omhyggelig vurdering af risici og fordele mindst en gang hver 6. måned, og behandlingen med Intrarosa bør kun fortsættes, så længe fordelene opvejer risiciene i henhold til lægens vurdering.
English: • If you have a rare blood problem called “porphyria” which is passed down in families (inherited);
Danish: • Hvis du har den sjældne blodsygdom "porfyri", der er en arvelig sygdom.
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 dokumentation for højere risiko for hukommelsestab hos kvinder, der begynder at bruge hormonerstatningsbehandling, efter at de er fyldt 65 år.
English: Table 3: Cmax and AUC0-24 of Prasterone, Testosterone, and Estradiol on Day 7 Following Daily Administration of Placebo or Intrarosa (mean ± S.D.)
Danish: Tabel 3: Cmax og AUC0-24 for prasteron, testosteron og østradiol på dag 7 efter daglig administration af placebo eller Intrarosa (gennemsnit ± SD)
English: Physical (including pelvic and breast) examination should be guided by this and by the contraindications and special warnings and precautions for use according to the decision of their doctor.
Danish: Ved den fysiske undersøgelse (herunder underlivs- og brystundersøgelse) bør lægen tage højde for sygehistorien og de angivne kontraindikationer og særlige advarsler og forsigtighedsregler vedrørende brugen.
English: • If you have a vaginal infection you will need a course of antibiotics before taking Intrarosa.
Danish: • Hvis du har infektion i skeden, skal du tage en antibiotikakur, inden du begynder at tage Intrarosa.
English: • Known or suspected oestrogen-dependent malignant tumours (e.g endometrial cancer);
Danish: • Kendt eller formodet østrogenafhængig malign tumor (f.eks. corpuscancer).
English: • Untreated endometrial hyperplasia;
Danish: • Ubehandlet endometriehyperplasi.
English: If you notice any of the following when taking HRT:
Danish: hvis du bemærker noget af følgende, når du bruger hormonerstatningsbehandling:
English: Intrarosa is a white to off-white, bullet-shaped pessary approximately 28 mm long and 9 mm in diameter at its widest end.
Danish: Intrarosa er et hvidt til offwhite projektilformet vagitorie med en længde på ca. 28 mm og en diameter på ca. 9 mm i den brede ende.
English: Follow the above instructions of Step 2, and then insert the pessary into the vagina with your finger as far as it can comfortably go. Do not use force.
Danish: Følg vejledningen i trin 2, og før vagitoriet så langt ind i skeden med din pegefinger, som du føler er komfortabelt.
English: The most frequently observed adverse reaction was vaginal discharge.
Danish: De hyppigst observerede bivirkninger var vaginalt udflåd.
English: Intrarosa does not affect your ability to drive and use machines.
Danish: Intrarosa påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: The applicator should then be withdrawn and disassembled, and the two pieces of the applicator should be rinsed for 30 seconds under running water before wiping with paper towel and reassembled.
Danish: De to applikatordele skylles under rindende vand i 30 sekunder, hvorefter de aftørres med køkkenrulle og samles igen.
English: Due to melting of the hard fat base added to an expected increase in vaginal secretions due to treatment, vaginal discharge can occur although it does not require to stop the medication (see section 4.8).
Danish: Da det hårde fedtstof smelter, og da behandlingen desuden forventes at give øget vaginal sekretion, kan der forekomme udflåd, men behandlingen behøver ikke ophøre af den grund (se pkt.
English: The risk ratio is not constant but will increase with increasing duration on use 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: Da baggrundsincidensen for brystcancer varierer fra land til land i EU, vil antallet af ekstra tilfælde af brystcancer øges proportionalt.
English: Risk ratio and 95%CI
Danish: Risikoratio og 95 %KI
English: • epilepsy;
Danish: • epilepsi
English: How to store Intrarosa 6.
Danish: Sådan skal du bruge Intrarosa 4.
English: Do not use this medicine after the expiry date which is stated on the carton and blisters after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when exogenous oestrogens are administered for prolonged periods.
Danish: Kvinder med intakt uterus har øget risiko for endometriehyperplasi og -karcinom ved langvarig behandling med eksogene østrogener.
English: • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency);
Danish: • Hvis du har en forstyrrelse i blodets koagulation (som f.eks. mangel på protein C, protein S eller antitrombin).
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 forhøjet risiko for venøs tromboemboli, og risikoen kan muligvis øges ved hormonerstatningsbehandling.
English: It is not required to stop Intrarosa if vaginal discharge occurs (see section 4.4).
Danish: Det er ikke nødvendigt at seponere Intrarosa, hvis der forekommer vaginalt udflåd (se pkt.
English: One case of breast cancer at week 52 has been reported on 1196 women who have been exposed with the 6.5 mg dose which is below the incidence rate observed in the normal population of the same age.
Danish: Der er rapporteret om ét tilfælde af brystcancer i uge 52 blandt 1196 kvinder, der blev eksponeret for en dosis på 6,5 mg, hvilket er lavere end forekomsten hos den normale population med samme alder.
English: For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users.
Danish: For kvinder i alderen 50-54 år, som har taget HRT i 5 år, svarer det til ca. 1 yderligere tilfælde pr. 2 000 brugere.
English: “Substantial improvement” was restricted to patients who had moderate or severe MBS at baseline and changed from severe to mild or severe or moderate to none.
Danish: "Væsentlig bedring" var forbeholdt kvinder, der havde moderat eller svær dyspareuni (det mest generende symptom) ved baseline, og som oplevede en bedring fra svære gener til milde gener eller fra svære eller moderate gener til ingen gener.
English: Uncommon (≥ 1/1,000 to < 1/100)
Danish: Ikke almindelig (≥ 1/1 000 til
English: - The active substance is prasterone.
Danish: - Aktivt stof: prasteron.
English: Incidence per 1000 women in placebo arm over 5 years
Danish: Forekomst pr. 1 000 kvinder i placebogruppen i en 5årig periode
English: • The use of oestrogen-only and oestrogen + progestagen therapy is associated with an up to 1.5 fold increased relative risk of ischaemic stroke.
Danish: • Behandling med østrogen alene og østrogen + progestagen er forbundet med en op til 1,5 gange forhøjet relativ risiko for iskæmisk apopleksi.
English: The risk of haemorrhagic stroke is not increased during use of HRT.
Danish: Risikoen for hæmoragisk apopleksi er ikke forhøjet under hormonerstatningsbehandling.
English: • Hypersensitivity to the active substance or to the excipient listed in section 6.1;
Danish: • Overfølsomhed over for det aktive stof eller over for hjælpestoffet anført i pkt.
English: Results of the WHI studies are presented:
Danish: Nedenfor vises resultaterne af WHI-undersøgelserne.
English: Intrarosa has not been studied in women with abnormal Pap smears (Atypical Squamous Cells of Undetermined Significance (ASCUS)) or worse.
Danish: Intrarosa er ikke undersøgt hos kvinder med unormale smear-test (ASCUS (atypiske pladeepitelceller af uvis signifikans)) eller værre tilstande.
English: Do not use force.
Danish: Du må ikke trykke for hårdt.
English: No data on efficacy and safety are available in women currently treated with hormonal therapy such as: androgens, hormone replacement therapy (oestrogen alone or combined with progestogens).
Danish: Der er ingen tilgængelige data om virkning og sikkerhed hos kvinder, der aktuelt er i hormonbehandling med f.eks. androgener eller hormonerstatningsbehandling (østrogen alene eller kombineret med progestogener).
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 nedenstående gælder for dig.
English: • The risk of coronary artery disease is slightly increased in users of combined oestrogen-progestagen HRT over the age of 60 (see section 4.4).
Danish: • Der er let forhøjet risiko for koronararteriesygdom ved brug af HRT med kombineret østrogen + progestagen hos kvinder over 60 år (se pkt.
English: If you have a premature menopause the risks of using HRT may be different.
Danish: Hvis du er gået i overgangsalderen før tid, kan brug af hormonerstatningsbehandling være forbundet med andre risici.
English: • Previous or current venous thromboembolism (deep vein thrombosis, pulmonary embolism);
Danish: • Tidligere eller nuværende tromboemboli (dyb venetrombose, lungeemboli).
English: Risk ratio & 95%CI#
Danish: Risikoratio og 95 %-KI#
English: WHI studies combined - Additional risk of ischaemic stroke*4 over 5 years' use
Danish: WHI-undersøgelserne kombineret - forøgelse af risikoen for iskæmisk apopleksi*4 ved 5 års brug
English: Prasterone corrects the symptoms and signs of vulvar and vaginal atrophy by replacing the oestrogens which are normally produced before menopause by the ovaries of women.
Danish: Prasteron afhjælper symptomer og tegn på tørre slimhinder i skeden ved at erstatte det østrogen, som kvindernes æggestokke normalt producerer før overgangsalderen.
English: Intrarosa has not been studied in women with a current hormonal treatment: hormone replacement therapy (oestrogens alone or combined with progestogens) or androgens treatment.
Danish: Intrarosa er ikke undersøgt hos kvinder i aktuel hormonbehandling: hormonerstatningsbehandling (østrogener alene eller kombineret med progestogener) eller androgenbehandling.
English: For women who have been taking HRT for 5 years, there will be about 3 cases per 2000 users (i.e. about 1 extra case).
Danish: Blandt kvinder, der har fået hormonerstatningsbehandling i 5 år, vil der være ca. 3 tilfælde pr. 2 000 brugere (dvs. 1 ekstra tilfælde).
English: The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogenprogestagen and possibly also oestrogen-only systemic HRT, that is dependent on the duration of taking HRT.
Danish: Den samlede evidens tyder på, at risikoen for brystcancer øges hos kvinder, der får systemisk HRT med en kombination af østrogen og progestagen og muligvis også med østrogen alene, og at risikoen afhænger af behandlingens varighed.
English: How much to use Use one pessary once a day, at bedtime.
Danish: Hvor meget skal du tage Du skal tage ét vagitorie hver dag ved sengetid.
English: • blood clots in the veins of the legs or lungs (venous thromboembolism);
Danish: • blodpropper i venerne i benene og i lungerne (venøs tromboemboli)
English: Dyspareunia
Danish: Dyspareuni
English: One Case of ovarian cancer has been reported on 1196 women who have been exposed with the 6.5 mg dose which is above the incidence rate observed in the normal population of the same age.
Danish: Der er rapporteret om ét tilfælde af ovariecancer blandt 1196 kvinder, der blev eksponeret for en dosis på 6,5 mg, hvilket er en højere forekomst end hos den normale population med samme alder.
English: Cases of ovarian and breast cancer have rarely been reported in women treated with 6.5 mg of prasterone for 52 weeks.
Danish: Der er kun i sjældne tilfælde rapporteret om æggestokkræft og brystkræft hos kvinder, der er blevet behandlet med 6,5 mg prasteron i 52 uger.
English: Vaginal douching is recommended.
Danish: Skedeskylning anbefales.
English: Cases of abnormal Pap smears corresponding to ASCUS or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported in women treated with the 6.5 mg dose (common frequency).
Danish: Der er rapporteret om tilfælde af unormale smear-test svarende til ASCUS eller LGSIL (lavgrads skvamøs intraepitelial læsion) hos kvinder, der er blevet behandlet med en dosis på 6,5 mg (med hyppigheden almindelig).
English: • various skin disorders: - discoloration of the skin especially of the face or neck known as “pregnancy patches” (chloasma); - painful reddish skin nodules (erythema nodosum); - rash with target-shaped reddening or sores (erythema multiforme).
Danish: • forskellige hudlidelser: - misfarvning af huden, navnlig på ansigt og hals (graviditetsmaske, kloasma) - smertefuld knudeformet rødme af huden (erythema nodosum) - udslæt med skydeskiveformet rødme eller sår (erythema multiforme).
English: • Place the flat end of the pessary into the open end of the activated applicator as shown.
Danish: • Den flade ende af vagitoriet skal placeres i den åbne ende af den aktiverede applikator som vist på figuren.
English: • Leave your index (pointer) finger free to press the applicator plunger after the applicator is inserted into your vagina.
Danish: • Din pegefinger skal være fri til at trykke applikatorens stempel ned, når du har ført applikatoren ind i skeden.
English: Systemic oestrogen-only therapy is associated with an up to 1.5-fold increase in risk of ischaemic stroke.
Danish: Systemisk behandling med østrogen alene er forbundet med en op til 1,5 gange forhøjet risiko for iskæmisk apopleksi.
English: Cases of breast and ovarian cancer have been reported in women treated with 6.5 mg of prasterone for 52 weeks (see section 4.4).
Danish: Der er rapporteret om tilfælde af bryst- og ovariecancer hos kvinder, der er blevet behandlet med 6,5 mg prasteron i 52 uger (se pkt.
English: There is some evidence of increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65.
Danish: Der foreligger nogen evidens for forhøjet risiko for demens hos kvinder, der efter 65-årsalderen påbegynder kontinuerlig HRT (kombineret eller med østrogen alene).
English: One case of pulmonary embolism has been reported in the 6.5 mg group and one in the placebo group during clinical trials.
Danish: I kliniske undersøgelser er der rapporteret om lungeemboli hos én patient i 6,5 mg-gruppen og hos én patient i placebogruppen.
English: Additional cases per 1000 HRT users over 5 years (95%CI)
Danish: Ekstra tilfælde pr. 1 000 kvinder, der har fået HRT i en 5-årig periode (95 %-KI)
English: Concomitant use with systemic hormone replacement therapy (oestrogen-only or oestrogenprogestagen combination or androgen treatment) or vaginal oestrogens has not been investigated and is therefore not recommended.
Danish: Samtidig anvendelse af systemisk HRT (østrogen alene eller kombineret østrogen/progestagen eller androgenbehandling) eller vaginale østrogener er ikke undersøgt og anbefales derfor ikke.
English: Prasterone is metabolised into estrogenic compounds.
Danish: Prasteron metaboliseres til østrogenforbindelser.
English: Trial 1 Trial 2
Danish: Undersøgelse 1 Undersøgelse 2
English: The following risks apply to HRT medicines which circulate in the blood.
Danish: Nedenstående risici er knyttet til hormonerstatningsbehandling, når de pågældende stoffer findes i blodet.
English: The applicator should be inserted into the vagina as far as it can comfortably go without force.
Danish: Applikatoren bør føres så langt ind i skeden, som kvinden føler komfortabelt, uden at forcere.
English: - Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura.
Danish: - galdeblæresygdom - hud og subkutane væv: chloasma, erythema multiforme, erythema nodosum, vaskulær purpura - mulig demens ved alder over 65 (se pkt.
English: Lying position
Danish: Liggende stilling
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE PAKNING
English: • probable memory loss if HRT is started over the age of 65.
Danish: • mulig hukommelsessvækkelse, hvis hormonerstatningsbehandlingen påbegyndes efter det 65. år.
English: Instructions on how to use Intrarosa How should I use Intrarosa
Danish: Vejledning i brug af Intrarosa Sådan skal du bruge Intrarosa
English: 2 *WHI study in women with no uterus, which did not show an increase in risk of breast cancer 3 *Study in women with no uterus
Danish: 2 * WHI-undersøgelse af kvinder uden uterus, hvor der ikke sås øget risiko for brystcancer.
English: • Systemic HRT is associated with a 1.3-3 fold risk of developing venous thromboembolism (VTE), i.e. deep vein thrombosis or pulmonary embolism.
Danish: • Systemisk HRT er forbundet med en 1,3-3 gange forhøjet risiko for at udvikle venøs tromboemboli (VTE), dvs. dyb venetrombose eller lungeemboli.
English: However, if the next dose is due in less than 8 hours, skip the missed pessary.
Danish: Hvis den næste dosis er planlagt til mindre end 8 timer senere, bør du dog springe det glemte vagitorie over.
English: • Gently slide the pessary end of the applicator into your vagina as far as it will comfortably go.
Danish: • Før forsigtigt den ende af applikatoren, hvor vagitoriet sidder, så langt ind i skeden, som du føler er komfortabelt.
English: Other medicines and Intrarosa
Danish: Brug af anden medicin sammen med Intrarosa
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: HRT er forbundet med 1,3-3 gange forhøjet relativ risiko for venøs tromboemboli (VTE), dvs. dyb venetrombose eller lungeemboli.
English: Each pessary contains 6.5 mg of prasterone.
Danish: Hvert vagitorie indeholder 6,5 mg prasteron.
English: It should be taken into account that these conditions may recur or be aggravated during treatment with Intrarosa, in particular: - Leiomyoma (uterine fibroids) or endometriosis - Risk factors for thromboembolic disorders (see below) - Risk factors for oestrogen dependent tumours, e.g. 1st degree heredity for breast cancer - Hypertension - Liver disorders (e.g. liver adenoma) - Diabetes mellitus with or without vascular involvement - Cholelithiasis - Migraine or (severe) headache - Systemic lupus erythematosus.
Danish: - leiomyom (uterusfibrom) eller endometriose - risikofaktorer for tromboemboliske forstyrrelser (se nedenfor) - risikofaktorer for østrogenafhængige tumorer, f.eks. 1.-grads arvelig disposition for brystcancer - hypertension - leversygdomme (f.eks. leveradenom) - diabetes mellitus med eller uden vaskulære skader - cholelithiasis - migræne eller (svær) hovedpine - systemisk lupus erythematosus - endometriehyperplasi i anamnesen (se nedenfor) - epilepsi - astma - otosklerose.