FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you become pregnant;
Danish: • Hvis du bliver gravid.
English: The potential risk in humans is unknown.
Danish: En eventuel risiko for mennesker kendes ikke.
English: Date of first authorisation: 08 january 2018
Danish: Dato for første markedsføringstilladelse: 08 januar 2018
English: • any lumps you can see or feel.
Danish: • enhver knude, der kan ses eller mærkes.
English: − Rinse the 2 pieces for 30 seconds under running water;
Danish: − Skyl de 2 dele i 30 sekunder under rindende vand;
English: • Regularly check your breasts.
Danish: • Kontrollér dine bryster regelmæssigt.
English: It is not known if this medicine affects fertility.
Danish: Det vides ikke, om dette lægemiddel påvirker frugtbarheden.
English: Keep it in a clean place.
Danish: Opbevar den på et rent sted.
English: Substantial improvement Intrarosa Placebo Intrarosa Placebo Intrarosa Placebo
Danish: Væsentlig bedring Intrarosa Placebo Intrarosa Placebo Intrarosa Placebo
English: Place the applicator on a clean surface.
Danish: Placér applikatoren på en ren overflade.
English: Elderly No dose adjustment is considered necessary in elderly women.
Danish: Ældre Dosisjustering vurderes ikke at være nødvendigt hos ældre kvinder.
English: • you have cancer.
Danish: • Du har kræft.
English: Vaginal use.
Danish: Vaginal anvendelse.
English: MedDRA System Organ Class
Danish: MedDRA's systemorganklasse
English: Ask your doctor when you can start taking Intrarosa again.
Danish: Spørg lægen, hvornår du kan begynde at tage Intrarosa igen.
English: Speak to your doctor if you think this dose is too strong or not strong enough.
Danish: Tal med lægen, hvis du mener, at dosen er for høj eller ikke høj nok.
English: B. Using the finger
Danish: B. Brug af pegefingeren
English: Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary.
Danish: Lægen vil bestræbe sig på at ordinere den lavest mulige dosis til behandling af dit symptom i så kort tid som muligt.
English: “Improvement” was defined as a reduction in the severity score of 1 or more.
Danish: "Bedring" blev defineret som en reduktion i sværhedsgradsscore på 1 eller mere.
English: • you are seriously overweight (BMI >30 kg/m2);
Danish: • Du er svært overvægtig (BMI >30 kg/m2).
English: Additionally, you are advised to join mammography screening programs when offered to you.
Danish: Derudover bør du deltage i mammografiscreeningsprogrammer, når du bliver tilbudt dette.
English: Physiological responses (objective measures)
Danish: Fysiologisk respons (objektive mål)
English: Endoceutics S.A. Rue Belliard 40 1040 Brussels Belgium
Danish: Endoceutics S.A. Rue Belliard 40 1040 Bruxelles Belgien
English: Elimination Systemic elimination has not been studied specifically for this application.
Danish: Elimination Systemisk elimination er ikke undersøgt specifikt i denne anvendelse.
English: HRT is therefore contraindicated in these patients (see section 4.3).
Danish: HRT er derfor kontraindiceret hos disse patienter (se pkt.
English: • you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery);
Danish: • Du kan ikke gå i længere tid på grund af en stor operation, skade eller sygdom (se også punkt 3 "Hvis du skal opereres").
English: If inserted with an applicator, the following steps should be followed:
Danish: Hvis der anvendes applikator, bør følgende trin følges:
English: • To wash the applicator:
Danish: • For at vaske applikatoren:
English: However, it returns to normal within a few years (at most 5) after stopping treatment.
Danish: Den vender dog tilbage til det normale niveau i løbet af få år (højst 5), efter at man er holdt op med behandlingen.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Intrarosa in all subsets of the paediatric population.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af undersøgelser med Intrarosa i alle undergrupper af den pædiatriske population.
English: However, they should be considered in case of long term or repeated use of this product.
Danish: De bør dog tages med i betragtning ved længere tids eller gentagen behandling med dette lægemiddel.
English: If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy.
Danish: Hvis det er mindre end 12 måneder siden, at du sidst havde menstruation, eller hvis du er under 50 år, kan du stadig have behov for yderligere prævention for at beskytte dig mod graviditet.
English: Before you start (or restart) HRT, your doctor will ask about your own and your family's medical history.
Danish: Før du påbegynder (eller genoptager) hormonerstatningsbehandling, vil lægen spørge til din egen og din families sygehistorie.
English: If you need to have surgery
Danish: Hvis du skal opereres
English: Wash it or throw it away after using for one week (two extra applicators are provided).
Danish: Vask den, eller smid den ud efter brug i en uge (to ekstra applikatorer medfølger).
English: Free or biological active hormone concentrations are unchanged.
Danish: Koncentrationen af frit (biologisk aktivt) hormon er uændret.
English: 1 *Taken from baseline incidence rates in developed countries
Danish: 1 * Baseret på baseline-forekomsten i udviklede lande
English: It is inserted into your vagina, so the hormone is released where it is needed.
Danish: Det indføres i skeden, så hormonet frigives dér, hvor der er brug for det.
English: If a dose is forgotten, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis glemmes, bør den tages, så snart patienten kommer i tanker om det.
English: • you have systemic lupus erythematosus (SLE);
Danish: • Du har systemisk lupus erythematosus (SLE).
English: Symptoms (subjective measures)
Danish: Symptomer (subjektive mål)
English: Endometrial safety
Danish: Endometriesikkerhed
English: If you get bleeding or spotting, it's usually nothing to worry about, but you should make an appointment to see your doctor.
Danish: Hvis du får blødning eller pletblødning, er det normalt ikke noget at bekymre sig om, men du bør dog bestille en tid hos lægen.
English: Standing position
Danish: Stående stilling
English: • migraine-like headaches which happen for the first time;
Danish: • Migrænelignende hovedpine, der optræder for første gang.
English: Apart from the main two 12-week phase III clinical studies, the safety data of Intrarosa has also been obtained from one non comparative open-label safety study of one year.
Danish: Ud over de to kliniske fase III-hovedundersøgelser af 12 ugers varighed foreligger der også sikkerhedsdata for Intrarosa fra en åben, ikkekomparativ sikkerhedsundersøgelse af et års varighed.
English: T3 resin uptake is decreased, reflecting the elevated TBG.
Danish: Optagelsen af T3-resin er nedsat, hvilket afspejler det forhøjede TBG.
English: • migraine or severe headaches;
Danish: • migræne eller svær hovedpine
English: Systemic metabolism has not been studied in this application.
Danish: Systemisk metabolisering er ikke undersøgt i denne anvendelse.
English: 28 pessaries.
Danish: 28 vagitorier.
English: Additional cases per 1000 HRT users
Danish: Yderligere tilfælde pr. 1 000 HRT-brugere
English: You may need to stop taking Intrarosa about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, Blood clots in a vein).
Danish: Det kan være nødvendigt at stoppe brugen af Intrarosa ca. 4-6 uger før operationen for at reducere risikoen for en blodprop (se punkt 2 "Blodpropper i en vene (trombose)").
English: These may be signs of a liver disease;
Danish: Dette kan være tegn på en leversygdom.
English: Of note, this case was present before start of treatment and was bearing a BRCA1 mutation.
Danish: Det skal bemærkes, at sygdommen var til stede før behandlingsstart, og at den pågældende patient var bærer af en BRCA1mutation.
English: • HRT use does not improve cognitive function.
Danish: • Anvendelse af hormonerstatningsmidler forbedrer ikke den kognitive funktion.
English: In the event of overdose, vaginal douching is recommended.
Danish: I tilfælde af overdosering anbefales skedeskylning.
English: Conditions which need supervision
Danish: Sygdomme, der kræver overvågning
English: • If a pessary falls on an unsanitary surface, replace it with a new one.
Danish: • Hvis et vagitorie tabes på en ikke rengjort overflade, skal du erstatte det med et nyt.
English: Treatment should not be restarted until the woman is completely mobilised.
Danish: Behandlingen bør ikke genoptages, før patienten er helt mobil igen.
English: • Porphyria.
Danish: • Porfyri.
English: • Carefully remove the pessary from the plastic wrap.
Danish: • Fjern forsigtigt vagitoriet fra plasticindpakningen.
English: Pharmacotherapeutic group: Other sex hormones and modulators of the genital system, ATC code: G03XX01.
Danish: Farmakoterapeutisk klassifikation: Andre kønshormoner og modulatorer af genitalsystemet, ATC-kode: G03XX01.
English: • Select the position for insertion of the pessary that is most comfortable for you.
Danish: • Vælg den stilling for indsætning af vagitoriet, som er mest komfortabel for dig.
English: • Empty your bladder and wash your hands before handling the pessary and applicator.
Danish: • Tøm din blære, og vask dine hænder, før du tager fat i vagitoriet og applikatoren.
English: However, Intrarosa has been shown to have very low absorption into the blood, therefore the addition of a progestagen is not necessary.
Danish: Det er dog påvist, at Intrarosa kun optages i blodet i meget lav grad, og det er derfor ikke nødvendigt at tilføje et progestagen.
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 HRT 4-6 uger forinden.
English: Carcinogenic and reproductive and development toxicity studies were not performed.
Danish: Der er ikke udført undersøgelser af karcinogenicitet eller reproduktions- og udviklingstoksicitet.
English: Pull back on the plunger until it stops to activate the applicator.
Danish: Træk stemplet tilbage, indtil det stopper, for at aktivere applikatoren.
English: This may include an examination of your breasts and/or an internal examination, if necessary.
Danish: Dette kan omfatte en undersøgelse af brysterne og/eller om nødvendigt en indvendig gynækologisk undersøgelse.
English: Inform your doctor if any of these situations applies to you:
Danish: Sig det til lægen, hvis noget af følgende gælder for dig:
English: It is caused by a drop in the levels of oestrogen in your body.
Danish: Årsagen er et fald i koncentrationen af østrogen i kroppen.
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin, ceruloplasmin).
Danish: Andre plasmaproteiner kan være forhøjet (angiotensinogen/reninsubstrat, alfa-I-antitrypsin, ceruloplasmin).
English: • Hold the applicator between your thumb and middle finger.
Danish: • Hold applikatoren mellem tommel- og langfingeren.
English: It is uncertain whether a risk exists with Intrarosa used for long term (more than one year) treatments.
Danish: Det er uvist, hvorvidt der er en risiko ved brug af Intrarosa i lang tid (mere end et år).
English: Do not take Intrarosa if any of the following applies to you.
Danish: Du bør ikke tage Intrarosa, hvis noget af nedenstående gælder for dig.
English: The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it.
Danish: Hormonerstatningsbehandling medfører risici, som der skal tages højde for ved vurderingen af, om du skal begynde at tage Intrarosa, eller om du skal blive ved med at tage det.
English: Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer' below).
Danish: Patienterne bør have at vide, hvilken type brystforandringer de skal tale med lægen eller sygeplejersken om (se afsnittet "Brystcancer" nedenfor).
English: A. Using the applicator
Danish: A. Brug af applikatoren
English: • changes in the nipple;
Danish: • forandringer i brystvorterne
English: If so, you should see your doctor more often for check-ups:
Danish: Hvis dette er tilfældet, bør du lade lægen undersøge dig oftere:
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 og/eller har oplevet forværring af en eller flere af nedenstående sygdomme under graviditet eller tidligere hormonbehandling, bør patienten overvåges tæt.
English: There are no data on the use of Intrarosa in pregnant women.
Danish: Der er ingen data fra anvendelse af Intrarosa til gravide kvinder.
English: Go for regular breast screening, as recommended by your doctor.
Danish: Få brysterne undersøgt regelmæssigt som anbefalet af lægen.
English: It is less likely that the conditions mentioned below will get worse or come back during treatment with Intrarosa, but you should see your doctor if you are concerned.
Danish: Det er ikke særlig sandsynligt, at de tilstande, der nævnes nedenfor, forværres eller kommer tilbage under behandlingen med Intrarosa, men du bør kontakte lægen, hvis du er bekymret.
English: Hard fat (adeps solidus).
Danish: Hårdfedt (adeps solidus).
English: If you are going to have surgery, tell the surgeon that you are taking Intrarosa.
Danish: Hvis du skal opereres, skal du fortælle kirurgen, at du tager Intrarosa.
English: As in all postoperative patients, prophylactic measures need be considered to prevent VTE following surgery.
Danish: Som hos alle postoperative patienter skal VTE-profylakse overvejes efter kirurgi.
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 ses efter få års brug, men vender tilbage til baseline-niveauet i løbet af få (højst fem) år efter ophør af behandlingen.
English: If you become pregnant, stop taking Intrarosa and contact your doctor.
Danish: Hvis du bliver gravid, skal du holde op med at tage Intrarosa og kontakte din læge.
English: The occurrence of such an event is more likely in the first year of HRT than later (see section 4.8).
Danish: Sandsynligheden for sådanne hændelser er større i det første år med HRT end senere (se pkt.
English: • high blood pressure;
Danish: • forhøjet blodtryk
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: Patienterne bør have at vide, at de skal søge læge med det samme, hvis de mærker potentielle symptomer på tromboemboli (f.eks. smertefuld hævelse i benet, pludselige smerter i brystet, dyspnø).
English: Coronary artery disease (CAD)/ Hypertension
Danish: Koronararteriesygdom (CAD)/hypertension
English: − Take it to pieces;
Danish: − Skil den i to dele;
English: Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Intrarosa.
Danish: Fortæl det til lægen, hvis du har haft et eller flere af nedenstående problemer, før du begynder på behandlingen, da de kan vende tilbage eller blive værre under behandling med Intrarosa.
English: The distribution of intravaginal (exogenous) prasterone is mainly local but some increase in systemic exposure is observed especially for the metabolites but within normal values.
Danish: Fordelingen af intravaginalt (eksogent) prasteron er hovedsageligt lokal, men der ses en lille stigning i systemisk eksponering for navnlig metabolitterne, dog inden for de normale værdier.
English: A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.311.56).
Danish: En metaanalyse fra 52 epidemiologiske studier viste en forhøjet risiko for ovariecancer hos kvinder, der er i hormonerstatningsbehandling, sammenlignet med kvinder, der aldrig har brugt HRT (RR 1,43, 95 %-KI 1,31-1,56).
English: The applicator must be activated before use.
Danish: Applikatoren skal aktiveres inden brug.
English: The applicator should be kept in a clean place until next use.
Danish: Applikatoren bør opbevares et rent sted, indtil den skal bruges igen.
English: • increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer);
Danish: • øget risiko for en østrogenfølsom kræfttype (f.eks. hvis din mor, søster eller bedstemor har haft brystkræft)
English: • If you have or have ever had breast cancer, or if you are suspected of having it;
Danish: • Hvis du har eller tidligere har haft brystkræft, eller hvis der er mistanke om, at du har det.
English: #Overall risk ratio.
Danish: # Samlet risikoratio.
English: Each applicator should be discarded after one week of usage (two extra applicators are provided).
Danish: Applikatoren bør kasseres efter en uges brug (to ekstra applikatorer medfølger).
English: • Remove the applicator.
Danish: • Træk applikatoren ud.
English: Abnormal Pap smear (mostly ASCUS or LGSIL)
Danish: Unormal smear-test (primært ASCUS eller LGSIL)
English: Blister composed of an outer layer of PVC and an inner layer of LDPE.
Danish: Blisterpakning med udvendigt lag af PVC og indvendigt lag af LDPE.
English: INFORMATION IN BRAILLE UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: INFORMATION I BRAILLESKRIFT ENTYDIG IDENTIFIKATOR - 2D-STREGKODE ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Investigations, including Pap smears and blood pressure measurements should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Danish: Der bør foretages undersøgelser, herunder smear-test og blodtryksmålinger, i henhold til anerkendt screeningspraksis, tilpasset den enkeltes kliniske behov.
English: Before initiating Intrarosa, a complete personal and family medical history should be taken.
Danish: Før igangsættelse af behandling med Intrarosa bør der optages en fuldstændig personlig og familiær anamnese.
English: Therefore caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis since intravaginal prasterone has not been studied in women with endometriosis.
Danish: Forsigtighed tilrådes derfor ved anvendelse af produktet hos kvinder, der har fået foretaget hysterektomi på grund af endometriose, navnlig hvis der er tilbageværende endometriose, da intravaginalt prasteron ikke er undersøgt hos kvinder med endometriose.
English: For more information about these side effects, see section 2.
Danish: Du kan læse mere om disse bivirkninger i punkt 2.
English: The flat end of the pessary should be placed into the open end of the activated applicator.
Danish: Den flade ende af vagitoriet bør placeres i den åbne ende af den aktiverede applikator.
English: Intrarosa is thus different from the oestrogens preparations since it delivers also androgen metabolites.
Danish: Intrarosa adskiller sig således fra andre østrogenpræparater derved, at det også giver androgenmetabolitter.
English: • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness);
Danish: • Kraftig blodtryksstigning (symptomerne kan være hovedpine, træthed og svimmelhed).
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: 28 pessaries are packed in a carton with 6 applicators.
Danish: 28 vagitorier er pakket i en æske med 6 applikatorer.
English: Once you have started on Intrarosa you should see your doctor for regular check-ups (at least every 6 months).
Danish: Når du først er startet på behandling med Intrarosa, bør du regelmæssigt blive undersøgt af lægen (mindst én gang hver 6. måned).
English: • HRT will not prevent memory loss.
Danish: • Hormonerstatningsbehandling forebygger ikke hukommelsestab.
English: - The only other ingredient is the hard fat (adeps solidus).
Danish: - Det eneste andet indholdsstof er hårdt fedtstof (Hårdfedt (adeps solidus)).
English: Basic Pharma Manufacturing B.V. Burgemeester Lemmensstraat 352 6163 JT Geleen
Danish: Burgemeester Lemmensstraat 352 6163 JT Geleen
English: • For oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range, it is not recommended to add a progestagen.
Danish: • Ved brug af østrogenprodukter til vaginal indføring, hvor den systemiske eksponering for østrogen ligger inden for det normale postmenopausale område, anbefales det ikke at tilføje et progestagen.
English: No studies in animals were performed with regard to the reproductive toxicity (see section 5.3).
Danish: Der er ikke gennemført dyreforsøg til vurdering af eventuel reproduktionstoksicitet (se pkt.
English: Intrarosa has not been studied in women with uncontrolled hypertension (blood pressure above 140/90 mmHg) and cardiovascular disease.
Danish: Intrarosa er ikke undersøgt hos kvinder med ukontrolleret hypertension (blodtryk på over 140/90 mmHg) og kardiovaskulær sygdom.
English: Note: Intrarosa is not a contraceptive.
Danish: Bemærk: Intrarosa er ikke et præventionsmiddel.
English: • In women with no personal history of VTE but with a first degree relative with a history of thrombosis at young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).
Danish: • Kvinder, der ikke har venøs tromboemboli i egen anamnese, men som har en førstegradsslægtning med trombose i ung alder i familieanamnesen, kan tilbydes screening efter omhyggelig rådgivning om screeningens begrænsninger (kun en del af trombofile defekter påvises ved screening).
English: Intrarosa is only used in adult women.
Danish: Intrarosa anvendes kun til voksne kvinder.
English: • The level of risk is dependent on the duration of use (see section 4.4).
Danish: • Risikoen afhænger af behandlingsvarigheden (se pkt.
English: Remove 1 applicator from the package.
Danish: Tag en applikator ud af pakningen.
English: On the 389 evaluable end-of-study endometrial biopsies performed after 52 weeks of treatment with Intrarosa, no histological abnormalities were reported on the biopsies.
Danish: I de 389 evaluerbare endometriebiopsier, der blev foretaget ved undersøgelsens afslutning efter 52 ugers behandling med Intrarosa, blev der ikke rapporteret om nogen histologiske anomalier.
English: At baseline, women had ≤ 5.0% superficial cells in the vaginal smear, a vaginal pH ˃ 5.0 and they had identified dyspareunia (moderate to severe) as their most bothersome symptom (MBS) of VVA.
Danish: Ved baseline havde kvinderne ≤ 5,0 % overfladeceller i vaginale smear-test, en vaginal pH-værdi ˃ 5,0, og de havde angivet dyspareuni (moderat til svær) som det mest generende symptom på VVA.
English: If any of the above conditions appears for the first time while taking Intrarosa, stop taking it at once and consult your doctor immediately.
Danish: Hvis nogen af ovennævnte sygdomme viser sig for første gang, mens du tager Intrarosa, skal du straks holde op med at tage det og kontakte lægen.