FrancophonIA/ELRC3.0 huggingface dataset:
English: Combination studies looked at Tekturna used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Danish: I kombinationsundersøgelserne blev Tekturna anvendt sammen med en angiotensinkonvertaseenzymhæmmer, ramipril, en angiotensinreceptorblokker (valsartan), en betablokker (atenolol), en kalciumkanalblokker (amlodipin) og et vanddrivende middel (hydrochlorthiazid).
English: The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (diastolic) or when the chambers of the heart were contracting (systolic).
Danish: Undersøgelserne varede mellem seks og 52 uger, og virkningen blev hovedsagelig bedømt ved ændringen i blodtrykket, som enten var det diastoliske blodtryk (blodtrykket i hvilefasen mellem to hjerteslag) eller det systoliske blodtryk (blodtrykket i hjertekamrenes sammentrækningsfase).
English: Tekturna should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Danish: Tekturna bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for aliskiren eller andre af indholdsstofferne.
English: What benefit has Tekturna shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Tekturna?
English: What is Tekturna?
Danish: Hvad er Tekturna?
English: What is Tekturna used for?
Danish: Hvad anvendes Tekturna til?
English: How has Tekturna been studied?
Danish: Hvordan blev Tekturna undersøgt?
English: Tekturna, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Danish: Tekturna blev dels taget alene, dels i kombination med andre lægemidler og blev sammenlignet med andre lægemidler mod for højt blodtryk.
English: Larger falls were seen in patients aged 65 years or over and those taking higher doses of Tekturna.
Danish: Hos patienter over 65 år og hos dem, der fik Tekturna i større doser, blev blodtrykket sænket yderligere.
English: How is Tekturna used?
Danish: Hvordan anvendes Tekturna?
English: How does Tekturna work?
Danish: Hvordan virker Tekturna?
English: Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Danish: Må ikke bruges til drægtige dyr, som skal producere mælk til konsum, inden for 2 måneder førforventet kælvning.
English: Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Dyrearter, som læge-midlet er beregnet til
English: Each transdermal patch releases 203 micrograms of NGMN and 33.9 micrograms of EE per 24 h.
Danish: Hvert depotplaster frigiver 203 mikrogram NGMN og 33,9 mikrogram EE i løbet af 24 timer.
English: Each transdermal patch contains 6 mg norelgestromin (NGMN) and 600 micrograms ethinyl estradiol (EE).
Danish: 18 depotplastre Hvert depotplaster indeholder 6 mg norelgestromin (NGMN) og 600 mikrogram ethinylestradiol (EE).
English: --1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
Danish: Lyofilisat (levende svækket) Hundeparainfluenza type 2 virus, stamme CPiV-2-Bio 15
English: * Tissue culture infectious dose 50%.
Danish: ALR** titre ≥ 1:51 * Vævskulturinficerende dosis - 50 % (tissue culture infectious dose 50 %).
English: The same place must not be used again until at least seven days later.
Danish: Det samme sted må ikke anvendes igen før mindst syv dage senere.
English: Intrinsa testosterone
Danish: Intrinsa testosteron
English: It may take longer than a month for the patient to feel an improvement.
Danish: Det kan tage over en måned, før patienten oplever en forbedring.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Intrinsa on 28 July 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Intrinsa den 28. juli 2006.
English: The company will also provide an educational plan for doctors and patients.
Danish: Virksomheden skal udvikle en undervisningsplan for både læger og patienter.
English: This document is a summary of the European public assessment report (EPAR) for Intrinsa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Intrinsa.
English: Women should contact their doctor if they notice any of these effects.
Danish: Kvinder bør kontakte deres læge, hvis de bemærker en eller flere af disse virkninger.
English: Intrinsa was more effective than placebo.
Danish: Intrinsa var mere effektivt end placebo.
English: Other information about Intrinsa:
Danish: Andre oplysninger om Intrinsa:
English: If a patient does not feel any improvement after three to six months of treatment, she should contact her doctor and have her treatment reviewed.
Danish: En patient, der efter tre til seks måneders behandling ikke oplever nogen forbedring, bør kontakte sin læge og få sin behandling revurderet.
English: The two main studies involved 1,095 women with an average age of 49 years who received Intrinsa for up to a year.
Danish: De to hovedundersøgelser omfattede 1 095 kvinder med en gennemsnitsalder på 49 år, som havde fået Intrinsa i op til et år.
English: The patch remains on the skin for three or four days and is then replaced by a new patch in a different place.
Danish: Plastret bliver siddende på huden i tre eller fire dage og udskiftes så med et nyt plaster, der sættes på et andet sted.
English: The patch releases 300 micrograms of the active substance testosterone over 24 hours.
Danish: Plastret frigiver 300 mikrogram af det aktive stof testosteron over 24 timer.
English: Intrinsa is used as a continuous treatment, as one patch twice a week.
Danish: Intrinsa anvendes som kontinuerlig behandling i form af ét plaster to gange om ugen.
English: Because testosterone is a well-known substance that is already used in other medicines, the company used data from the published literature as well as carrying out studies itself.
Danish: Da testosteron er et velkendt aktivt stof, der allerede anvendes i andre lægemidler, anvendte virksomheden data fra den offentliggjorte faglitteratur og gennemførte desuden undersøgelser selv.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Intrinsa.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Intrinsa.
English: The full EPAR for Intrinsa can be found here.
Danish: Den fuldstændige EPAR for Intrinsa findes her.
English: The main measure of effectiveness was based on the change in the questionnaire score before the study began and after six months of treatment.
Danish: Den vigtigste målestok for virkningen var forskellen på pointtal i spørgeskemaet, inden undersøgelsen begyndte og seks måneder efter behandlingen.
English: It is used in patients already taking an oestrogen (a female
Danish: Det anvendes til patienter, der allerede tager et østrogen (et kvindeligt kønshormon).
English: Intrinsa was compared with placebo (a patch containing no active substance).
Danish: Intrinsa blev sammenlignet med placebo (et plaster, som intet aktivt stof indeholder).
English: The studies used a specially designed questionnaire to measure sexual interest and activity by recording the number of satisfying sexual episodes in a four-week period.
Danish: Undersøgelserne anvendte et specielt udarbejdet spørgeskema til måling af den seksuelle interesse og aktivitet ved at registrere antallet af tilfredsstillende seksuelle episoder i en fireugers periode.
English: The active substance in Intrinsa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Danish: Det aktive stof i Intrinsa, testosteron, er et naturligt kønshormon, der produceres hos mænd og i mindre grad hos kvinder.
English: For more information about treatment with Intrinsa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Intrinsa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The company will review all of the ongoing studies with Intrinsa to look at potential long-term risks including breast cancer, endometrial cancer (cancer of the lining of the womb) and side effects affecting the heart and blood vessels.
Danish: Den skal gennemgå alle igangværende undersøgelser med Intrinsa for at se på de potentielle langsigtede risici, herunder brystkræft, endometriecancer (kræft i livmoderslimhinden) og bivirkninger, der påvirker hjertet og blodkarrene.
English: Because testosterone is a male sex hormone, women who are taking Intrinsa should be monitored to see if they develop any ‘androgenic' side effects (development of male characteristics) such as hair growth on the face, deepening of the voice or hair loss.
Danish: Da testosteron er et mandligt kønshormon, bør kvinder, der tager Intrinsa, overvåges med henblik på at se, om de udvikler 'androgene bivirkninger' (udvikling af mandlige karaktertræk) såsom hårvækst i ansigtet, dybere stemme eller hårtab.
English: Women using Intrinsa should also use oestrogens, but not of the type known as ‘conjugated oestrogens' because the combination of these with Intrinsa is not as effective as the combination of other types of oestrogen with Intrinsa.
Danish: Kvinder, der anvender Intrinsa, bør også tage østrogener, men ikke af den type, der er kendt som ‘konjugerede østrogener', da disse ikke er lige så effektive i kombination med Intrinsa som med andre typer østrogen.
English: Intrinsa should not be used in people who may be hypersensitive (allergic) to testosterone or any of the other ingredients.
Danish: Intrinsa bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for testosteron eller andre af indholdsstofferne.
English: It must not be used in women who have or have had breast cancer or another oestrogen-dependent cancer, or who have other conditions that mean that they cannot take oestrogen-containing medicines.
Danish: Det må heller ikke anvendes af kvinder, der har eller har haft brystkræft eller andre østrogenafhængige kræfttyper, eller af kvinder med andre tilstande, der gør, at de ikke kan tage østrogenholdige lægemidler.
English: Intrinsa is a transdermal patch (a patch that delivers a medicine across the skin).
Danish: Intrinsa er et transdermalt plaster (et plaster, der afgiver et lægemiddel gennem huden).
English: The CHMP decided that Intrinsa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Intrinsa opvejede risiciene og anbefalede udstedelse af markedsføringstilladelse for Intrinsa.
English: The most common side effects with Intrinsa (seen in more than 1 patient in 10) are hirsutism (increased hair growth, especially on the chin and upper lip) and reactions at the site of application of the patch (redness and itching).
Danish: De mest almindelige bivirkninger ved Intrinsa (set hos flere end 1 ud af 10 patienter) var hirsutisme (øget hårvækst, navnlig på hage og over læberne) og reaktioner på det sted, hvor plastret blev sat på (rødme og kløe).
English: In contrast, women who used placebo had around four episodes in a four-week period after six months.
Danish: I modsætning hertil havde kvinder, som fik placebo, ca. fire episoder i en fireugers periode efter seks måneder.
English: The company that makes Intrinsa will monitor some of the side effects of Intrinsa closely, such as its androgenic side effects.
Danish: Virksomheden, som fremstiller Intrinsa, skal nøje overvåge nogle af bivirkningerne fra Intrinsa såsom de androgene bivirkninger.
English: Intrinsa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the womb and ovaries.
Danish: Intrinsa frigiver testosteron gennem huden ind i blodbanen for at opnå det samme testosteronniveau, som inden livmoderen og æggestokkene blev fjernet.
English: When the results of the two studies were looked at together, the women who used Intrinsa had an average of 1.07 more satisfying sexual episodes than the women who used placebo over a four-week period.
Danish: Når resultaterne fra de to undersøgelser blev analyseret sammen, oplevede de kvinder, der anvendte Intrinsa en gennemsnitlig forbedring på 1,07 tilfredsstillende seksuelle episoder i forhold til de kvinder, der fik placebo over en fireugers periode.
English: What is the risk associated with Intrinsa?
Danish: Hvilken risiko er der forbundet med Intrinsa?
English: Why has Intrinsa been approved?
Danish: Hvorfor blev Intrinsa godkendt?
English: The patch is applied to dry, clean skin on the lower abdomen (the tummy below the waist).
Danish: Plastret sættes på tør, ren hud på den nederste del af abdomen (på maven under taljen).
English: Low testosterone levels have been linked to low sexual desire and to reduced sexual thoughts and arousal.
Danish: Lave testosteronniveauer har været associeret med nedsat seksuallyst og seksuelle tanker samt med nedsat seksuel ophidselse.
English: The marketing authorisation holder is Warner Chilcott UK Ltd.
Danish: Indehaveren af markedsføringstilladelsen er Warner Chilcott UK Ltd. Markedsføringstilladelsen er gyldig i fem år, hvorefter den kan fornys.
English: What information is still awaited for Intrinsa?
Danish: Hvilke oplysninger afventes der stadig for Intrinsa?
English: In women who have had their womb and ovaries removed, the amount of testosterone produced is halved.
Danish: Hos kvinder, som har fået fjernet deres livmoder og æggestokke, er den mængde testosteron, der produceres, halveret.
English: For the full list of all side effects reported with Intrinsa, see the
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Intrinsa fremgår af indlægssedlen.
English: On average, women who had three satisfying sexual episodes in a four-week period before treatment had around five episodes over four weeks after using Intrinsa for six months.
Danish: Dette betyder i gennemsnit, at kvinder, der inden behandlingen havde tre tilfredsstillende seksuelle episoder i en fireugers periode, havde fem sådanne episoder i en fireugers periode efter at havde taget Intrinsa i seks måneder.
English: Intrinsa is used to treat lack of sexual thoughts and desire that is causing distress in women who have had their womb and both ovaries removed.
Danish: Intrinsa anvendes til behandling af kvinder, der har problemer med manglende seksuallyst og seksuelle tanker efter at have fået fjernet deres livmoder og begge æggestokke.
English: What is Intrinsa used for?
Danish: Hvad anvendes Intrinsa til?
English: How has Intrinsa been studied?
Danish: Hvordan blev Intrinsa undersøgt?
English: How is Intrinsa used?
Danish: Hvordan anvendes Intrinsa?
English: What benefit has Intrinsa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Intrinsa?
English: How does Intrinsa work?
Danish: Hvordan virker Intrinsa?
English: This is because it may harm an unborn baby.
Danish: Det er fordi, det kan skade et ufødt barn.
English: It is important that you take the total recommended dose each day.
Danish: Det er vigtigt, at du tager den fulde anbefalede dosis hver dag.
English: • Your female partner must also use a suitable method of contraception.
Danish: • Din kvindelige partner skal også bruge en passende præventionsmetode.
English: The clinical relevance of this effect is unknown.
Danish: Den kliniske relevans af denne virkning er ikke kendt.
English: There were no confirmed responses in the comparator arm.
Danish: Der var ingen bekræftede responser i komparator-armen.
English: Two highly effective and complementary forms of contraception are recommended.
Danish: Det anbefales at anvende to højeffektive og komplementære former for antikonception.
English: • you have problems with your kidneys.
Danish: • du har problemer med nyrerne.
English: Based on stratified log-rank test.
Danish: Baseret på stratificeret log-rank test
English: However, the number of patients is too limited to make meaningful conclusions on the efficacy in this subgroup.
Danish: Antallet af patienter er imidlertid for begrænset til at træffe afgørende konklusioner om effekten i denne subgruppe.
English: Therefore, the specific dose recommendations for each formulation should be followed.
Danish: Derfor skal den specifikke dosisanbefaling for den enkelte formulering følges.
English: Your doctor may prescribe a different dose if:
Danish: Lægen kan udskrive en anden dosis, hvis:
English: June 2021
Danish: juni 2021
English: June 2020
Danish: juni 2020
English: Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis (to doser samtidig) som erstatning for den glemte dosis.
English: Elimination Following a single dose of
Danish: Elimination Efter en enkelt dosis af
English: The capsules must be discarded after this period.
Danish: Kapslerne skal destrueres efter denne periode.
English: * Not controlled for multiplicity.
Danish: * Ikke kontrolleret for multiplicitet.
English: However, there was a slight reduction in embryofoetal survival.
Danish: Der var imidlertid en let reduktion af embryoføtal overlevelse.
English: • at regular intervals decided by your doctor after the first year of treatment.
Danish: • i regelmæssige intervaller, som bestemmes af din læge efter det første års behandling.
English: Your doctor may lower your dose or stop treatment, either for a short time or permanently.
Danish: Lægen kan reducere din dosis eller stoppe behandlingen, enten i kortere tid eller permanent.
English: It is recommended that you record the date when the capsules are removed from refrigerator and the date after which they should be discarded.
Danish: Det anbefales, at du noterer datoen for hvornår kapslerne er taget ud af køleskabet, og datoen for hvornår de bør kasseres.
English: • before treatment
Danish: • inden behandling
English: Your doctor will tell you if there are any changes in your blood test that might need treatment.
Danish: Lægen vil fortælle dig, hvis der sker nogen ændringer i dine blodprøver, som kan kræve behandling.
English: • every month for the first year of treatment
Danish: • hver måned i det første års behandling
English: For women with hormone dependent cancer, two non-hormonal contraceptive methods should be considered.
Danish: Til kvinder med hormonafhængig cancer bør to ikke-hormonelle antikonceptionsmetoder overvejes.
English: o bruising or bleeding for longer than usual if you hurt yourself
Danish: o blå mærker eller blødning i længere tid end normalt, hvis du kommer til skade
English: • Do not chew, crush, dissolve or divide the tablets as this may affect how quickly the medicine gets into your body.
Danish: • Du må ikke tygge, knuse, opløse eller dele tabletterne, da det kan påvirke, hvor hurtigt medicinen bliver optaget i din krop.
English: There are no clinical data on fertility.
Danish: Der findes ingen kliniske data om fertilitet.
English: It can affect the way the medicine works.
Danish: Det kan påvirke den måde, hvorpå medicinen virker.
English: • a vaccine or a medicine that suppresses the immune system, as you may need to be closely monitored
Danish: • en vaccine eller en medicin, der undertrykker immunsystemet, da du i så fald kan have brug for at blive fulgt nøje
English: • increase in blood creatinine - this test is used to check how your kidneys are working.
Danish: • stigning i blodkreatinin - denne test bruges til at undersøge, hvordan dine nyrer fungerer.
English: Number of patients at risk:
Danish: Antal patienter i risiko:
English: months 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 nolaparib nplacebo
Danish: Måneder 0 6 12 18 24 30 36 42 48 54 60 66 72 78 84 90 96 nolaparib nplacebo
English: BOTTLE/LABEL
Danish: FLASKE/ETIKET
English: You will have a blood test:
Danish: Du vil få taget en blodprøve:
English: Levels appeared to return to normal after treatment discontinuation and did not appear to have any clinical consequences.
Danish: Niveauet syntes at vende tilbage til normal efter seponering af behandlingen og syntes ikke at have nogen kliniske konsekvenser.
English: • diarrhoea - if it gets severe, tell your doctor straight away.
Danish: • diarré - hvis den bliver voldsom, skal du straks fortælle det til lægen.
English: These changes were reversible within 4 weeks of cessation of dosing.
Danish: Disse ændringer var reversible inden for 4 uger efter afbrydelse af doseringen.
English: Figure 7 PFS (BICR), Forest plot, by prespecified subgroup
Danish: Figur 7 PFS (BICR), Forest-plot, efter præspecificeret subgruppe
English: Tell your doctor straight away if you notice any of the following:
Danish: Fortæl det straks til lægen, hvis du bemærker noget af følgende:
English: Probability of progression free survival
Danish: Sandsynligheden for progressionsfri overlevelse
English: Seven patients, all stage IV, had no cytoreductive surgery.
Danish: Syv patienter, alle i stadie IV, fik ingen cytoreduktiv operation.
English: Majority of the material was excreted as metabolites.
Danish: Størstedelen af materialet blev udskilt som metabolitter.
English: Consistent results were observed in all predefined patient subgroups (see Figure 7).
Danish: Konsistente resultater blev observeret i alle foruddefinerede patientsubgrupper (se figur 7).
English: If you become pregnant during this time, you must talk to your doctor straight away.
Danish: Hvis du bliver gravid i dette tidsrum, skal du straks tale med din læge.
English: INNER CARTON - with no blue box
Danish: INDRE ÆSKE - uden blue box
English: Pneumonitis is a serious condition that can often require hospital treatment.
Danish: Pneumonitis er en alvorlig tilstand, der ofte kræver behandling på hospitalet.
English: There are limited clinical data in patients aged 75 years and over.
Danish: Der er begrænsede kliniske data for patienter i alderen 75 år og derover.
English: Post-hoc analysis.
Danish: Post hoc-analyse
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2C - 8C).
English: If you feel dizzy, weak or tired while taking Lynparza, do not drive or use tools or machines.
Danish: Hvis du føler dig svimmel, svag eller træt mens du tager Lynparza, må du ikke føre motorkøretøj eller bruge værktøj eller maskiner.
English: Many had also received other DNA damaging agents and radiotherapy.
Danish: Mange havde også fået andre DNA-beskadigende stoffer og strålebehandling.
English: Lynparza capsules can be stored for up to 3 months below 30°C.
Danish: Lynparza kapsler kan opbevares i op til 3 måneder under 30C.
English: Table 7 Patient demographic and baseline characteristics in OlympiAD
Danish: Tabel 7 Patientdemografiske og baseline egenskaber i OlympiAD
English: Uncommon side effects that may show up in blood tests: • increase in the size of red blood cells (not associated with any symptoms).
Danish: Ikke almindelige bivirkninger, der kan ses i blodprøver: • øgning i størrelsen af de røde blodlegemer (ikke forbundet med nogen symptomer).
English: A value < 1 favours olaparib.
Danish: En værdi <1 favoriserer olaparib.
English: Antiemetic prophylaxis is not required.
Danish: Antiemetisk profylakse er ikke påkrævet.
English: You should have received chemotherapy medicines either before or after your cancer has spread.
Danish: Du skal have modtaget kemoterapi enten før eller efter din kræft har spredt sig.
English: Do not take Lynparza if any of the above apply to you.
Danish: Du må ikke tage Lynparza, hvis noget af det ovenstående gælder for dig.
English: Your doctor will test your blood every month for the first year of treatment and at regular intervals after that.
Danish: Lægen vil undersøge dit blod hver måned i det første år af behandlingen og regelmæssigt derefter.