FrancophonIA/ELRC3.0 huggingface dataset:
English: Since Intrarosa acts locally in the vagina, no dosage adjustment is needed for postmenopausal women having renal or hepatic impairment or any other systemic anomaly or disease.
Danish: Patienter med nedsat nyre- og/eller leverfunktion Da Intrarosa virker lokalt i skeden, er dosisjustering ikke nødvendigt hos postmenopausale kvinder med nedsat nyre- eller leverfunktion eller andre systemiske forstyrrelser eller sygdomme.
English: Heart disease (heart attack) / Hypertension
Danish: Hjertesygdomme (hjerteanfald)/forhøjet blodtryk
English: Intrarosa has not been studied in women with endometrial hyperplasia.
Danish: Intrarosa er ikke blevet undersøgt hos kvinder med endometriehyperplasi.
English: For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over 5 years (i.e. an extra 3 cases).
Danish: Blandt kvinder i 50'erne, som får hormonerstatningsbehandling, vil der være 11 tilfælde for hver 1 000 brugere (dvs. 3 ekstra tilfælde) i løbet af en periode på 5 år.
English: • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE);
Danish: • systemisk lupus erythematosus (en immunsygdom, der berører mange organer, SLE)
English: Cases of abnormal Pap smears either Atypical Squamous Cells of Undetermined Significance (ASCUS) or Low Grade Squamous Intraepithelial Lesion (LSIL) have been reported with a common frequency in women treated with Intrarosa for 52 weeks (see section 4.4).
Danish: Med hyppigheden almindelig er der rapporteret om tilfælde af unormale smear-test (ASCUS (atypiske pladeepitelceller af uvis signifikans) eller LSIL (lavgrads skvamøs intraepitelial læsion)) hos kvinder, der er blevet behandlet med Intrarosa i 52 uger (se pkt.
English: Pregnancy Intrarosa is not indicated in pre-menopausal women of child-bearing age, including pregnancy.
Danish: Graviditet Intrarosa er ikke indiceret hos præmenopausale kvinder, der kan få børn, eller som er gravide.
English: • growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia);
Danish: • vækst af livmoderslimhinden uden for livmoderen (endometriose) eller fortykkelse af livmoderslimhinden (endometriehyperplasi)
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 (endometriehyperplasi) og livmoderkræft (corpuscancer)
English: Theramex Ireland Limited Tel/Teл./Τηλ: + 353 (0) 15138855
Danish: Theramex Ireland Limited Tel/ Teл./Τηλ: + 353 (0) 15138855 INTRAROSA.Enquiries@theramex.com
English: Weight fluctuation
Danish: Vægtudsving
English: • Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal
Danish: • Akut eller tidligere leversygdom, så længe leverfunktionsværdierne ikke er normaliseret.
English: • breast cancer;
Danish: • brystkræft
English: This is likely due to melting of the hard fat added to an expected increase in vaginal secretions due to treatment.
Danish: Det skyldes sandsynligvis smeltning af det hårde fedtstof samt øget vaginal sekretion på grund af behandlingen.
English: What you need to know before you use Intrarosa
Danish: Det skal du vide, før du begynder at bruge Intrarosa
English: The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
Danish: Brug af hormonerstatningsbehandling med østrogen alene har været forbundet med let forhøjet risiko for kræft i æggestokkene.
English: Additional cases per 1000 never-users of HRT over a 5 year period*1
Danish: 1 000 kvinder, der ikke har fået HRT i en 5-årig periode*1
English: The adverse reaction observed with prasterone 6.5 mg pessaries obtained from clinical studies is tabulated below.
Danish: Bivirkningerne fra kliniske undersøgelser af prasteronholdige vagitorier a 6,5 mg er vist i tabellen nedenfor.
English: The pessary should be inserted in the vagina as far as it can comfortably go without force.
Danish: Vagitoriet bør føres så langt ind i skeden, som kvinden føler komfortabelt, uden at forcere.
English: US WHI studies - additional risk of breast cancer after 5 years' use
Danish: WHI-undersøgelserne i USA - forøgelse af risikoen for brystcancer efter 5 års brug
English: STEP 5
Danish: Trin 5
English: Estradiol
Danish: Østradiol
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only systemic HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Danish: Epidemiologisk evidens fra en omfattende metaanalyse tyder på, at risikoen er let forhøjet hos kvinder, der får systemisk HRT med østrogen alene.
English: No cases of arterial thromboembolic disease have been reported during clinical trials.
Danish: Der er ikke rapporteret om tilfælde af arteriel tromboemboli i kliniske undersøgelser.
English: In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Danish: For kvinder i alderen 50-54 år, der ikke tager HRT, diagnosticeres ca. 2 ud af 2 000 kvinder med ovariecancer i løbet af en periode på 5 år.
English: There is no relevant use of Intrarosa in female children of any age group for the indication of vulvar and vaginal atrophy due to menopause.
Danish: Det er ikke relevant at anvende Intrarosa hos pigebørn og unge piger i indikationen overgangsalderrelateret vulvær og vaginal atrofi.
English: The plunger of the applicator should be pressed to release the pessary.
Danish: Applikatorens stempel trykkes i bund for at frigive vagitoriet.
English: WHI Studies - Additional risk of VTE over 5 years' use
Danish: WHI-undersøgelserne - forøgelse af risikoen for VTE ved 5 års brug
English: • Press the applicator plunger with your index (pointer) finger to release the pessary.
Danish: • Tryk stemplet i bund med pegefingeren for at frigøre vagitoriet.
English: • a disease affecting the eardrum and hearing (otosclerosis);
Danish: • otosklerose (en sygdom, der rammer trommehinden og giver nedsat hørelse)
English: • You may have vaginal discharge due to melting of the ‘hard fat base' which adds to increased vaginal secretions due to treatment.
Danish: • Du kan opleve udflåd fra skeden som følge af, at det hårde fedtstof smelter, i tillæg til den øgede skedesekretion som følge af behandlingen.
English: Cervical/ uterine polyps Breast mass (benign)
Danish: Cervix-/uteruspolypper Knude i brystet (godartet)
English: Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would be expected to have a stroke over a 5-year period.
Danish: Blandt kvinder i 50'erne, der ikke får hormonerstatningsbehandling, forventes i gennemsnit 8 ud af 1 000 kvinder at få et slagtilfælde i løbet af en periode på 5 år.
English: No case of coronary artery disease has been reported during clinical trials.
Danish: Der er ikke rapporteret om tilfælde af koronararteriesygdom i kliniske undersøgelser.
English: STEP 1
Danish: Trin 1
English: Million Women study- Estimated additional risk of breast cancer after 5 years' use
Danish: MWS-undersøgelsen - estimeret øget risiko for brystcancer efter 5 års brug
English: • Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4);
Danish: • Kendte trombofile forstyrrelser (f.eks. mangel på protein C, protein S eller antitrombin, se pkt.
English: Intrarosa has not been studied in women with history of thromboembolic diseases, uncontrolled hypertension or heart disease.
Danish: Intrarosa er ikke undersøgt hos kvinder med tidligere tromboembolisk sygdom, ikke-kontrolleret forhøjet blodtryk eller hjertesygdom.
English: However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age (see section 4.8).
Danish: Baseline-risikoen for apopleksi er imidlertid stærkt aldersafhængig, hvorfor den totale risiko for apopleksi stiger med alderen hos kvinder i hormonerstatningsbehandling (se pkt.
English: • Tear off one wrapped pessary from the 7-pessary strip.
Danish: • Tryk ét indpakket vagitorie ud af blisterpakningen med 7 vagitorier.
English: No case of stroke has been observed with Intrarosa during clinical trials.
Danish: Der er ikke observeret slagtilfælde med Intrarosa under de kliniske forsøg.
English: The use of Intraorsa in combination with hormone replacement therapy (oestrogen-only or oestrogenprogestagen combination or androgen treatment) or vaginal oestrogens is not recommended.
Danish: Brug af Intrarosa i kombination med hormonerstatningsbehandling (østrogenbehandling alene, kombineret østrogen/progestagenbehandling eller androgenbehandling) eller vaginale østrogenpræparater frarådes.
English: Other conditions observed with HRT
Danish: Andre tilstande, der er observeret ved hormonerstatningsbehandling
English: Intrarosa is for use in postmenopausal women only.
Danish: Intrarosa er kun til brug hos kvinder efter overgangsalderen.
English: During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Danish: Under behandlingen anbefales det at kontrollere patienterne så ofte og på en sådan måde, som det skønnes relevant i det enkelte tilfælde.
English: Table 2: Percentage of Patients with Improvement, Relief or Substantial Improvement of MBS Dyspareunia after 12 Weeks on Intrarosa vs.
Danish: Tabel 2: Andelen af kvinder, der oplevede bedring, lindring eller væsentlig bedring af dyspareuni (det mest generende symptom) efter 12 ugers behandling med Intrarosa sammenholdt med placebo (ITT, LOCF)
English: For more information, see ‘Blood clots in a vein (thrombosis)'
Danish: Yderligere oplysninger findes under "Blodpropper i en vene (trombose)".
English: It is available in blister packs of 28 pessaries with 6 applicators.
Danish: Intrarosa fås i blisterpakninger med 28 vagitorier og 6 applikatorer.
English: Pessary.
Danish: Vagitorie.
English: Use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see section 4.4).
Danish: Anvendelse af HRT med østrogen alene og/eller med en kombination af østrogen og progestagen har været forbundet med en let forhøjet risiko for at få ovariecancer (se pkt.
English: • a liver disorder, such as a benign liver tumour;
Danish: • leversygdomme som f.eks. en godartet leversvulst
English: Trial 2
Danish: Undersøgelse 2
English: STEP 3
Danish: Trin 3
English: Trial 1
Danish: Undersøgelse 1
English: Intrarosa is used to treat postmenopausal women having moderate to severe symptoms of vulvar and vaginal atrophy.
Danish: Intrarosa anvendes til behandling af kvinder i overgangsalderen med moderate til svære symptomer på såkaldt vulvær og vaginal atrofi, dvs. tørre og irritable slimhinder i skeden.
English: This is due to melting of the hard fat used as vehicle, added to the expected increase in vaginal secretions due to treatment.
Danish: Det skyldes, at det hårde fedtstof smelter, og at behandlingen desuden forventes at give øget vaginal sekretion.
English: STEP 6
Danish: Trin 6
English: How to use Insert the pessary into the vagina with your finger or with an applicator provided in the pack.
Danish: Sådan skal du bruge Intrarosa Før vagitoriet ind i skeden med pegefingeren eller ved hjælp af den medfølgende applikator.
English: Abnormal Pap smear
Danish: Unormal smear-test
English: STEP 7
Danish: Trin 7
English: STEP 4
Danish: Trin 4
English: Taking oestrogen-only HRT tablets for a long time can increase the risk of developing cancer of the womb lining (the endometrium).
Danish: Længerevarende hormonerstatningsbehandling med tabletter, som kun indeholder østrogen, kan øge risikoen for livmoderkræft (corpuscancer).
English: Intrarosa is not meant for women with child-bearing potential.
Danish: Intrarosa er ikke beregnet til brug hos kvinder, der kan blive gravide.
English: STEP 2
Danish: Trin 2
English: • If you have any unexplained vaginal bleeding;
Danish: • Hvis du har blødning fra skeden af ukendt årsag.
English: Intrarosa has not been studied in women with current or previous arterial thromboembolic disease.
Danish: Intrarosa er ikke undersøgt hos kvinder med eksisterende eller tidligere arteriel tromboemboli.
English: How to store Intrarosa
Danish: Tag ikke Intrarosa
English: Intrarosa has not been studied in women with active or past breast cancer.
Danish: Intrarosa er ikke undersøgt hos kvinder med aktiv eller tidligere brystcancer.
English: • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining
Danish: • Hvis du har en østrogenfølsom kræftsygdom som f.eks. livmoderkræft (corpuscancer), eller hvis der er mistanke om, at du har det.
English: Intrarosa has not been studied in women with current or previous venous thromboembolic disease.
Danish: Intrarosa er ikke undersøgt hos kvinder med eksisterende eller tidligere venøs tromboemboli.
English: Intrarosa 6.5 mg pessary.
Danish: Intrarosa 6,5 mg, vagitorie.
English: Package leaflet: Information for the user Intrarosa 6.5 mg pessary prasterone This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Intrarosa 6,5 mg, vagitorie prasteron (prasteron.)
English: • ovarian cancer;
Danish: • æggestokkræft
English: Other adverse reactions have been reported in association with oestrogen/progestagen treatment: - Gall bladder disease.
Danish: Andre indberettede bivirkninger ved østrogen/progestagenbehandling:
English: Final study report by Q4 2021
Danish: Endelig undersøgelsesrappor t senest 4. kvartal
English: It is used to relieve menopausal symptoms in the vagina such as dryness or irritation.
Danish: Det bruges til at lindre denne overgangsalderrelaterede tørhed og irritation i skeden.
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: Blandt kvinder i 50'erne, der ikke får hormonerstatningsbehandling, vil 4-7 ud af 1 000 få en blodprop i en vene i løbet af en periode på 5 år.
English: Intrarosa 6,5 mg pessary prasterone
Danish: Intrarosa 6,5 mg, vagitorie prasteron.
English: The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited.
Danish: Der er kun begrænset erfaring med behandling af kvinder, der er gået i overgangsalderen før tid (som følge af problemer med æggestokkene eller operation).
English: Relief
Danish: Bedring
English: Intrarosa has not been studied in women with current or history of cancers.
Danish: Intrarosa er ikke undersøgt hos kvinder med aktuel eller tidligere kræft.
English: For example, in women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Danish: Risikoen for kræft i æggestokkene afhænger af kvindens alder. For kvinder i alderen 50-54 år, der ikke får hormonerstatningsbehandling, diagnosticeres eksempelvis ca. 2 ud af 2 000 kvinder med ovariecancer i løbet af en periode på 5 år.
English: − Wipe with a paper towel and reassemble.
Danish: − Tør delene med køkkenrulle og saml dem igen.
English: • gallstones;
Danish: • galdesten
English: Intrarosa has not been studied in women with active or past ovarian cancer.
Danish: Intrarosa er ikke undersøgt hos kvinder med aktiv eller tidligere ovariecancer.
English: • gall bladder disease
Danish: • galdeblæresygdom
English: If you use more Intrarosa than you should
Danish: Hvis du har brugt for meget Intrarosa
English: If vaginal discharge occurs, it is not required to stop Intrarosa.
Danish: Det er ikke nødvendigt at holde op med at bruge Intrarosa, hvis der ses udflåd.
English: − with a uncommon frequency (may affect up to 1 in 100 people): benign cervical or uterine polyps, benign breast mass.
Danish: Desuden er følgende bivirkninger indberettet: - Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede): unormal smear-test (som oftest ASCUS eller LGSIL), vægtstigning eller vægttab - Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 behandlede): godartede livmoder- og livmoderhalspolypper, godartet brysttumor.
English: • fibroids inside your womb;
Danish: • knuder i livmoderen (uterusfibromer)
English: Additional cases per 1000 HRT users over 5 years
Danish: 1 000 kvinder, der har fået HRT i en 5-årig periode
English: How to use Intrarosa
Danish: Sådan skal du bruge Intrarosa
English: In some cases this occurred as part of a
Danish: I nogle tilfælde opstod dette som en del af en
English: Date of first authorisation: 14 April 2011
Danish: Dato for første markedsføringstilladelse: 14. april 2011
English: A few patients have experienced these serious side effects.
Danish: Nogle få patienter har oplevet disse alvorlige bivirkninger.
English: Stevens-Johnson syndrome
Danish: Stevens-Johnson syndrom
English: 85 to 90% of the maximal blood-pressure-lowering effect was observed after 2 weeks.
Danish: 85-90 % af den maksimale blodtrykssænkende effekt blev observeret efter 2 uger.
English: The safety of Rasilamlo has been evaluated in studies of up to one year duration.
Danish: Sikkerheden af Rasilamlo er undersøgt i studier af op til et års varighed.
English: , headache (especially at the beginning of treatment)
Danish: , hovedpine (især i begyndelsen af behandlingen)
English: This effect is also seen with other medicinal products acting on
Danish: Denne virkning ses også for andre lægemidler, som virker
English: See also information under the heading “Do not take Rasilamlo”.
Danish: Se også information under overskriften ”Tag ikke Rasilamlo”.
English: The cumulative review retrieved 187 cases out of which 57 were sufficiently documented, in 8 of these cases a causal relationship could not be ruled out.
Danish: Den kumulative oversigt omfatter 187 tilfælde, af hvilke 57 var tilstrækkeligt dokumenterede, i 8 af disse tilfælde kunne en kausal sammenhæng ikke udelukkes.
English: The blood pressure reductions with the combination were maintained throughout the entire 24-hour dose interval.
Danish: Reduktionerne i blodtrykket med kombinationen blev opretholdt igennem hele det 24-timers doseringsinterval.
English: The tablets should be swallowed whole with some water.
Danish: Tabletterne skal synkes hele med noget vand.
English: Do not take this medicine if you are pregnant (see section Do not take Rasilamlo).
Danish: Du må ikke tage dette lægemiddel, hvis du er gravid (se afsnittet ”Tag ikke Rasilamlo”).
English: Very rare (may affect up to 1 in 10,000 people): • low level of white blood cells and blood platelets
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 patienter): • lavt niveau af hvide blodlegemer og blodplader
English: The primary endpoint was a composite of
Danish: Det primære endepunkt var en
English: , exfoliative dermatitis
Danish: , exfoliativ dermatitis
English: If your blood pressure is not controlled after 4 to 6 weeks, your doctor may adjust your dose.
Danish: Hvis dit blodtryk ikke er optimalt kontrolleret efter 4 til 6 uger, kan din læge tilpasse din
English: Your doctor will normally advise you to stop taking Rasilamlo before you become pregnant and will advise you to take another medicine instead of Rasilamlo.
Danish: Normalt vil din læge råde dig til at stoppe med at tage Rasilamlo, inden du bliver gravid, og råde dig til at tage anden medicin i stedet for Rasilamlo.
English: Via Provinciale Schito 131 IT-80058 Torre Annunziata Italy
Danish: Via Provinciale Schito 131 I-80058 Torre Annunziata/NA Italien
English: Always take this medicine exactly as your doctor has told you and do not exceed the recommended dose.
Danish: Tag altid lægemidlet nøjagtigt efter lægens anvisning og overskrid ikke den anbefalede dosis.
English: , peripheral neuropathy
Danish: , perifer neuropati
English: Not all pack sizes or strengths may be marketed.
Danish: Ikke alle pakningsstørrelser og styrker er nødvendigvis markedsført.
English: , increased urinary frequency
Danish: , øget vandladningsfrekvens
English: The adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opstillet efter frekvens med den hyppigste først ved anvendelse af følgende definition: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10): ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The antihypertensive effect is manifested within 1 week and the effect is near maximal at around 4 weeks.
Danish: Den antihypertensive virkning viser sig inden for 1 uge, og effekten er nær maksimal efter ca. 4 uger.
English: If you become pregnant while taking this medicine, stop taking it immediately and talk to your doctor.
Danish: Hvis du bliver gravid, mens du tager dette lægemiddel, skal du straks stoppe med at tage det og kontakte din læge.
English: No mortality or significant toxicity was observed.
Danish: Ingen mortalitet eller signifikant toksicitet blev oberservet.
English: The CHMP recommends that the terms of the Marketing Authorisations should be varied.
Danish: CHMP anbefaler, at betingelserne for markedsføringstilladelserne ændres.
English: As for any combination of two active substances, side effects associated with each individual component cannot be excluded.
Danish: Som for alle kombinationer af to aktive stoffer kan bivirkninger, der er forbundet med de enkelte aktive stoffer, ikke udelukkes.
English: Rasilamlo has been administered to more than 2,800 patients in completed clinical trials, including 372 patients for one year or more.
Danish: Rasilamlo er givet til mere end 2.800 patietenter i gennemførte kliniske afprøvninger, inklusive 372 patienter, der har fået det i et år eller længere.
English: It is unknown whether aliskiren and/or amlodipine are excreted in human milk.
Danish: Det er ukendt, om aliskiren og/eller amlodipin udskilles i human mælk.
English: Individual dose titration with each of the two components may be recommended before changing to the fixed combination.
Danish: Det kan anbefales at foretage individuel dosistitrering med de enkelte komponenter, inden der skiftes til den faste kombination.
English: Rasilamlo should be taken with a light meal once a day, preferably at the same time each day.
Danish: Rasilamlo bør tages med et let måltid én gang daglig, fortrinsvis på samme tidspunkt hver dag.
English: Rasilamlo should not be used during the first trimester of pregnancy.
Danish: Rasilamlo bør ikke anvendes under 1. trimester i graviditeten.
English: When clinically appropriate and in line with the above-mentioned posology, direct change from monotherapy to the fixed combination may be considered.
Danish: Når det er klinisk relevant og i overensstemmelse med ovenstående dosering, kan et direkte skift fra monoterapi til den faste kombination overvejes.
English: If you experience these, tell your doctor immediately.
Danish: Hvis du oplever dette, skal du kontakte din læge omgående.
English: Read all of this leaflet carefully before you start taking this medicine because it contains
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: Angiotensin II causes vasoconstriction and sodium and water reabsorption.
Danish: Angiotensin II medfører vasokonstriktion og reabsorption af natrium og vand.
English: Hepatic MDR1 mRNA expression was statistically significantly lower in samples from foetuses, neonates and infants up to 23 months.
Danish: Hepatisk MDR1-mRNA -ekspression var statistisk signifikant lavere i prøver fra fostre, nyfødte og børn op til 23 måneder.
English: The ratio of lethal dose of 100 mg/kg/day and no-observed-adverse-effect-level (NOAEL) of 30 mg/kg/day is unexpectedly low.
Danish: Forholdet mellem dødelig dosis på 100 mg/kg/dag og no-observed-adverse-effect-level (NOAEL) på 30 mg/kg/dag er uventet lille.