FrancophonIA/ELRC3.0 huggingface dataset:
English: The testosterone in Intrinsa is the same hormone as that produced naturally in men and women.
Danish: Testosteronet i Intrinsa er det samme hormon, som mænd og kvinder producerer naturligt.
English: Continued use of Intrinsa is only recommended while concomitant use of estrogen is considered appropriate (i.e. the lowest effective dose for the shortest possible duration).
Danish: Fortsat anvendelse af Intrinsa anbefales kun, mens samtidig brug af østrogen menes at være relevant (dvs. den laveste, effektive dosis i kortest mulige tid).
English: Effects of Intrinsa were observed at 4 weeks after initiation of therapy (the first measured time point) and at all monthly efficacy time points thereafter.
Danish: Der sås effekt af Intrinsa ved 4 uger efter behandlingsstart (først målte tidspunkt) og ved alle månedlige effekt-tidspunkter derefter.
English: In case of inadvertent exposure during pregnancy, use of Intrinsa must be discontinued.
Danish: I tilfælde af utilsigtet eksponering under graviditet skal brugen af Intrinsa seponeres.
English: Therefore, you need to discuss your type of estrogen with your doctor, who could advise you which type of estrogen is suitable together with Intrinsa.
Danish: De skal derfor drøfte østrogentypen med Deres læge, som kan rådgive om, hvilken type østrogen, det er bedst at tage sammen med Intrinsa.
English: In the combined study analysis at 24 weeks, the difference in the mean frequency of total satisfying episodes between Intrinsa and placebo was 1.07 per 4 weeks.
Danish: I den kombinerede forsøgsanalyse ved uge 24 var forskellen i gennemsnitshyppigheden af fuldstændig tilfredsstillende episoder mellem Intrinsa og placebo på 1,07 per 4 uger.
English: Driving and using machines You can drive and use machines while using Intrinsa.
Danish: Trafik- og arbejdssikkerhed De kan godt køre bil og betjene maskiner, mens De anvender Intrinsa.
English: If you have any of the above, tell your doctor before you start to use Intrinsa.
Danish: Hvis noget af ovenstående er tilfældet, skal De fortælle Deres læge det, før De begynder at anvende Intrinsa.
English: The safety of Intrinsa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration.
Danish: Intrinsas sikkerhed er ikke vurderet i dobbeltblinde, placebokontrollerede forsøg med længere varighed end 1 år.
English: There were no significant differences in serum estradiol and estrone levels in patients treated with Intrinsa for up to 52 weeks compared to baseline.
Danish: Der var ingen signifikant forskel i serumøstradiol og østronniveauet hos patienter behandlet med Intrinsa i op til 52 uger sammenlignet med baseline.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Intrinsa treatment response should be evaluated within 3-6 months of initiation, to determine if continued therapy is appropriate.
Danish: Respons på behandlingen med Intrinsa bør vurderes inden for 3-6 måneder efter behandlingsstart for at afgøre, om det er relevant at fortsætte behandlingen.
English: If an adverse reaction occurred at a higher frequency in the integrated phase III studies (Intrinsa patients n=1,498, placebo patients n=1,297), this frequency is reported in the table.
Danish: Hvis en bivirkning forekom med større frekvens i det integrerede fase III-forsøg (Intrinsa-patienter n=1.498, placebo-patienter n=1.297), vil denne frekvens være rapporteret i tabellen.
English: Intrinsa has no influence on the ability to drive and use machines.
Danish: Intrinsa påvirker ikke evnen til at føre bil eller betjene maskiner.
English: However, patients should be informed that migraine, insomnia, disturbance in attention and diplopia have been reported during treatment with Intrinsa.
Danish: Patienterne skal dog informeres om, at der er blevet rapporteret migræne, søvnløshed, opmærksomhedsforstyrrelser og dobbeltsyn under behandling med Intrinsa.
English: Two multi-centre, double-blind, placebo-controlled six month studies in 562 (INTIMATE SM1) and 533 (INTIMATE SM2) oophorectomised and hysterectomised women (surgically induced menopause), aged 20 to 70 years, with HSDD on concomitant estrogen were used to evaluate the efficacy and safety of Intrinsa.
Danish: To multicenter, dobbeltblinde, placebokontrollerede forsøg af seks måneders varighed med 562 (INTIMATE SM1) og 533 (INTIMATE SM2) kvinder med ovariektomi og hysterektomi (kirurgisk induceret menopause) i alderen 20 til 70 år med HSDD, som samtidig fik østrogen, blev anvendt til at vurdere Intrinsas effekt og sikkerhed.
English: Testosterone from Intrinsa is transported across intact skin by a passive diffusion process that is primarily controlled by permeation across the stratum corneum.
Danish: Testosteron fra Intrinsa transporteres igennem intakt hud via en passiv diffusionsproces, som primært kontrolleres af gennemtrængning af stratum corneum.
English: Intrinsa is recommended for use in surgically menopausal women up to the age of 60.
Danish: Intrinsa anbefales til brug hos kirurgisk menopausale kvinder op til 60 år.
English: Fertility No data is available of the effect of Intrinsa on fertility.
Danish: Fertilitet Der er ingen data for virkningen af Intrinsa på fertilitet
English: If you stop estrogen therapy you must also stop using Intrinsa.
Danish: Hvis De holder op med østrogenbehandlingen, skal De også holde op med at anvende Intrinsa.
English: DHT concentrations increased in parallel with testosterone concentrations during Intrinsa treatment.
Danish: DHT-koncentrationerne steg parallelt med testosteronkoncentrationerne under behandlingen med Intrinsa.
English: Intrinsa is a transdermal patch which constantly releases small amounts of testosterone that is absorbed through your skin into the bloodstream.
Danish: Intrinsa er et depotplaster, som konstant afgiver små mængder testosteron, som absorberes i blodet igennem huden.
English: On removal of an Intrinsa patch, testosterone serum concentrations return to near baseline values within 12 hours due to its short terminal exponential half-life (approximately 2 hours).
Danish: Når Intrinsa-plastret fjernes, falder testosteron serumkoncentrationen til værdier tæt på baseline inden for 12 timer på grund af den korte, eksponentielle halveringstid (cirka 2 timer).
English: It is not known whether Intrinsa increases the risk of breast cancer and endometrium cancer.
Danish: Det vides ikke, om Intrinsa øger risikoen for brystkræft og kræft i livmoderslimhinden.
English: Intrinsa should not be used in naturally menopausal women Efficacy and safety of Intrinsa in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated.
Danish: Intrinsa må ikke anvendes til naturligt menopausale kvinder Effekt og sikkerhed af Intrinsa hos naturligt menopausale kvinder med HSDD i samtidig østrogenbehandling med eller uden progestogen er ikke undersøgt.
English: What Intrinsa looks like and contents of the pack Intrinsa is a thin, clear, oval patch with T001 stamped on the back.
Danish: Udseende og pakningsstørrelser Intrinsa er et tyndt, klart, ovalt plaster med T001 trykt på bagsiden.
English: A significantly higher percentage of women who received Intrinsa reported a benefit in the three endpoints, that they considered clinically meaningful compared to women who received placebo.
Danish: En signifikant højere procentdel af de kvinder, som fik Intrinsa, end de kvinder, som fik placebo, rapporterede en fordel i de tre endpoints, som kvinderne betragtede som klinisk betydningsfulde.
English: Intrinsa is intended for use by women up to the age of 60 years who: - have a low sexual desire which is causing distress or concern, and - have had both of their ovaries removed, and - have had their womb removed (hysterectomy), and - are receiving estrogen therapy.
Danish: Intrinsa er beregnet til brug hos kvinder op til 60 år, som: - har ringe seksuel lyst, hvilket giver problemer eller bekymringer, og - har fået fjernet begge æggestokke, og - har fået fjernet livmoderen (hysterektomi), og - som får østrogenbehandling.
English: Overdosing with Intrinsa is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body.
Danish: Overdosering med Intrinsa er usandsynlig, når det anvendes efter instruktionerne, fordi testosteronen hurtigt udskilles af kroppen, når plastret tages af.
English: - If you are also using estrogen patches, make sure that the Intrinsa patch and the estrogen patch do not overlap.
Danish: - Hvis De også anvender østrogenplastre, skal De sørge for, at Intrinsa-plastret og østrogenplastret ikke overlapper hinanden.
English: Always use Intrinsa exactly as your doctor has told you.
Danish: Brug altid Intrinsa nøjagtigt efter lægens anvisning.
English: Abnormal blood fibrinogen, increased heart rate, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides
Danish: Vægtforøgelse Unormalt fibrinogen i blodet, øget hjerterytme, forhøjet alanin-aminotransferase, forhøjet aspartataminotransferase, forhøjet bilirubin i blodet, unormal leverfunktionstest, forhøjede triglycerider i blodet
English: To prevent interference with the adhesive properties of Intrinsa, no creams, lotions or powder should be applied to the skin where the patch is to be applied.
Danish: For at forhindre, at Intrinsas klæbeevne påvirkes, bør der ikke benyttes creme, lotion eller talkum på det hudområde, hvor plastret skal sidde.
English: Frequencies are defined as 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), or very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: < 1/100), sjældne (≥ 1/10.000 til < 1/1.000) eller meget sjældne (< 1/10.000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: Intrinsa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones.
Danish: Intrinsa påvirkede ikke serumkoncentrationerne af sexhormonbindende globulin (SHBG), østrogener eller binyrehormoner.
English: Intrinsa is designed to systemically deliver 300 micrograms/day.
Danish: Intrinsa er udviklet til systemisk udskillelse af 300 mikrogram/dag.
English: You should self assess for increased acne (a common side effect), increased hair growth on your face, loss of hair, deepening of your voice or enlargement of your clitoris, which all could be signs of side effects of testosterone, which is the active substance in Intrinsa.
Danish: De bør selv holde øje med tegn på øget acne (en almindelig bivirkning), øget hårvækst i ansigtet, hårtab, dybere stemme eller forstørrelse af clitoris, da det alt sammen kan være tegn på bivirkninger af testosteron, som er det aktive stof i Intrinsa.
English: HOW TO USE INTRINSA
Danish: SÅDAN SKAL DE BRUGE INTRINSA
English: However, this is not expected from the low dose of testosterone delivered by the Intrinsa patch.
Danish: Dette forventes dog ikke ved den lave dosis testosteron, Intrinsa-plastret afgiver.
English: If you have applied more than one patch at a time Remove all the patches sticking on to your skin and consult your doctor or pharmacist for further information on how to continue treatment with Intrinsa.
Danish: Fjern alle de plastre, som sidder på huden, og tal med Deres læge eller apotek for at få yderligere oplysninger om, hvordan De skal fortsætte behandlingen med Intrinsa.
English: The efficacy of Intrinsa is reduced if your estrogen therapy is of a certain type (‘conjugated equine estrogens').
Danish: Virkningen af Intrinsa reduceres, hvis De bliver behandlet med østrogen af en bestemt type (‘konjugerede ekvine østrogener').
English: Intrinsa is only indicated for women in their menopause after the ovaries and uterus have been removed.
Danish: Intrinsa er kun beregnet til kvinder i menopausen, efter at de har fået fjernet æggestokkene og livmoderen.
English: Do not use Intrinsa in case of breast-feeding because it may cause harm to the child.
Danish: Anvend ikke Intrinsa, hvis De ammer, da dette kan skade barnet.
English: Intrinsa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels.
Danish: Intrinsa er en transdermal behandling af HSDD, som øger kvindens seksuelle lyst, idet der opnås testosteronkoncentrationer, som svarer til det præmenopausale niveau.
English: Take special care with Intrinsa - if you have a history of heart, liver or kidney disease.
Danish: Vær ekstra forsigtig med at bruge Intrinsa - hvis De har eller har haft sygdomme i hjerte, lever eller nyrer.
English: Breast pain Breast cyst, clitoral engorgement, enlarged clitoris, genital pruritus, vaginal burning sensation
Danish: Bystsmerter Cyste i brystet, opsvulmet clitoris, forstørret clitoris, genitalkløe, brænden i vagina
English: Therefore, Intrinsa should not be used in women on concomitant CEE (see sections 4.2 and
Danish: Derfor bør Intrinsa ikke anvendes til kvinder i samtidig behandling med CEE (se pkt.
English: Serum concentrations of testosterone and SHBG in patients receiving Intrinsa in clinical safety and
Danish: Serumkoncentrationer af testosteron og SHBG hos patienter, som fik Intrinsa i kliniske sikkerheds-/ og effektforsøg.
English: Oedema may be a serious complication from high doses of testosterone, however, this is not expected from low dose of testosterone delivered by the Intrinsa patch.
Danish: Ødem kan være en alvorlig komplikation fra høje doser testosteron, men det forventes dog ikke med de lave doser testosteron, der frigøres fra Intrinsa-plastret.
English: Intrinsa should not be used in women on concomitant CEE Whereas Intrinsa is indicated with concomitant estrogen therapy, the subgroup of patients receiving oral conjugated equine estrogens (CEE) did not demonstrate a significant improvement in sexual function.
Danish: Intrinsa må ikke anvendes til kvinder med samtidig CEE Mens Intrinsa er indiceret med samtidig østrogenbehandling, udviste den undergruppe af patienter, som fik oralt konjugeret ekvint østrogen (conjugated equine estrogen, CEE), ikke nogen signifikant bedring af den seksuelle funktion.
English: They are usually reversible if Intrinsa treatment is
Danish: De kan som regel afhjælpes, hvis behandlingen med Intrinsa ophører.
English: Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Danish: Intrinsa er indiceret til behandling af hypoaktiv seksuel lyst (Hypoactive sexual desire disorder, HSDD) hos kvinder med bilateral ovariektomi og hysterektomi (kirurgisk induceret menopause) i samtidig østrogenbehandling.
English: Intrinsa is intended for use by women up to the age of 60 years who have had both their ovaries and their womb removed.
Danish: Intrinsa er beregnet til kvinder op til 60 år, som har fået fjernet begge æggestokke og livmoderen.
English: During 6-month double blind exposure the following adverse reactions occurred in the treatment group (n=549) at a greater incidence than placebo (n=545) and were assessed by the investigators as possibly or probably related to Intrinsa treatment.
Danish: Under den 6-måneders dobbeltblinde anvendelse forekom følgende bivirkninger i behandlingsgruppen (n=549) med større incidens end i placebogruppen (n=545).
English: Hirsutism Acne, alopecia Eczema, increased sweating, rosacea
Danish: Acne, alopeci Eksem, øget svedafsondring,
English: In the combined phase III data, excluding patients taking oral CEE, in whom there was no significant improvement in sexual function, 50.7 % of women (n=274) treated with Intrinsa and 29.4 % of those treated with placebo (n=269) were responders with regard to total satisfying sexual activity (primary endpoint), when a responder was predefined as having an increase in the 4-week frequency of satisfying activities of > 1.
Danish: Ifølge disse data responderede 50,7% af kvinderne (n=274), som blev behandlet med Intrinsa, og 29,4% af dem, der blev behandlet med placebo (n=269), på det primære endpoint, som var fuldstændig tilfredsstillende seksuel aktivitet.
English: - Keep out of the reach and sight of children - Do not use Intrinsa after the expiry date which is stated on the carton and sachet after EXP.
Danish: - Brug ikke Intrinsa efter den udløbsdato, der står på kartonen og brevet.
English: MARKETING AUTHORISATION HOLDER Warner Chilcott UK Limited
Danish: Indehaver af markedsføringstilladelsen Warner Chilcott UK Limited Old Belfast Road
English: Patients treated with conjugated equine estrogen (CEE) are not recommended to use Intrinsa, as efficacy has not been demonstrated (see sections 4.4 and 5.1).
Danish: Det anbefales, at patienter, der er behandlet med konjugeret ekvint østrogen (conjugated equine estrogen, CEE), undlader at anvende Intrinsa, da effekten ikke er påvist (se pkt.
English: Breastfeeding Intrinsa must not be used by breast-feeding women.
Danish: Amning Intrinsa må ikke anvendes af kvinder, som ammer.
English: - if you are allergic (hypersensitive) to testosterone or any of the other ingredients of Intrinsa (see section ‘Further information' at the end of this leaflet).
Danish: Brug ikke Intrinsa - hvis De er overfølsom (allergisk) over for testosteron eller et af de øvrige indholdsstoffer (se pkt.
English: What Intrinsa is and what it is used for Before you use Intrinsa How to use Intrinsa Possible side effects How to store Intrinsa Further information
Danish: Det skal De vide, før De begynder at bruge Intrinsa Sådan skal De bruge Intrinsa Bivirkninger
English: INFORMATION IN BRAILLE
Danish: INFORMATION I BRAILLE-SKRIFT Intrinsa
English: Intrinsa 300 micrograms/24 hours transdermal patch Testosterone
Danish: Intrinsa 300 mikrogram/24 timer depotplaster Testosteron
English: NAME OF THE MEDICINAL PRODUCT Intrinsa 300 micrograms/24 hours transdermal patch
Danish: LÆGEMIDLETS NAVN Intrinsa 300 mikrogram/24 timer depotplaster
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Intrinsa 300 micrograms/24 hours transdermal patch Testosterone
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Intrinsa 300 mikrogram/24 timer depotplaster Testosteron
English: BEFORE YOU USE INTRINSA
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE INTRINSA
English: NAME OF THE MEDICINAL PRODUCT Intrinsa 300 micrograms/24 hours transdermal patch Testosterone
Danish: LÆGEMIDLETS NAVN Intrinsa 300 mikrogram/24 timer depotplaster Testosteron
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Intrinsa til Dem personligt.
English: Arthritis
Danish: Dosering
English: Backing layer
Danish: BIVIRKINGER
English: Oral use blister OPA/alu/PVC/alu 7 tablets
Danish: Blister OPA/alu/PVC/alu
English: Immediate Packaging
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: Lu) oxodotreotide
Danish: Lu) oxodotreotid
English: Lutathera must not be given to women who are pregnant or in whom pregnancy has not been excluded.
Danish: Lutathera må ikke gives til kvinder, som er gravide, eller hos hvem graviditet ikke er blevet udelukket.
English: The patient cannot leave the controlled areas until told to do so by the doctor.
Danish: Patienten må ikke forlade de kontrollerede lokaler, før lægen give besked herom.
English: Other information about Lutathera
Danish: Andre oplysninger om Lutathera
English: It must also not be given to patients with severely reduced kidney function.
Danish: Det må heller ikke gives til patienter med stærkt nedsat nyrefunktion.
English: It is a radiopharmaceutical (a medicine that emits a small amount of radioactivity).
Danish: Det er et radioaktivt lægemiddel (dvs. det afgiver en lille smule radioaktivitet).
English: This is a summary of the European public assessment report (EPAR) for Lutathera.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lutathera.
English: This compares with around 9 months for patients treated with octreotide, a medicine already approved for treating the condition.
Danish: Dette kan sammenholdes med ca. 9 måneder for patienter, der blev behandlet med octreotid, som er et lægemiddel, der allerede er godkendt til behandling af sygdommen.
English: The radioactivity it emits then kills the tumour cells it is attached to but has little effect on neighbouring cells.
Danish: Den radioaktivitet, det afgiver, dræber derefter de kræftceller, det bindes til, men har ringe virkning på nabocellerne.
English: The patient should also be given an infusion of an amino acid solution which helps protect their kidneys.
Danish: Patienten skal desuden have en infusion af en aminosyreopløsning, som er med til at beskytte nyrerne.
English: What measures are being taken to ensure the safe and effective use of Lutathera?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lutathera?
English: Because Lutathera emits some radioactivity, it is only used in special controlled areas and must be handled and given to patients by qualified personnel.
Danish: Da Lutathera afgiver radioaktivitet, anvendes det kun i særlige kontrollerede lokaler og skal håndteres og gives til patienterne af kvalificeret personale.
English: Other common side effects affecting more than 1 in 10 patients are thrombocytopenia (low platelet counts), lymphopenia (low levels of lymphocytes, a type of white blood cell), anaemia (low red cell counts), pancytopenia (low levels of all types of blood cells), tiredness and reduced appetite.
Danish: Andre hyppige bivirkninger, der rammer mere end 1 ud af 10 patienter, er lavt blodpladetal (trombocytopeni), lavt antal hvide blodlegemer af typen lymfocytter (lymfopeni), lavt antal røde blodlegemer (anæmi), lavt antal af alle typer blodlegemer (pancytopeni), træthed og nedsat appetit.
English: It is not intended to provide practical advice on how to use Lutathera.
Danish: Det er ikke en praktisk vejledning i, hvordan Lutathera bør anvendes.
English: The usual treatment involves 4 infusions 8 weeks apart, but the gap between infusions can be increased to up to 16 weeks if the patient gets severe side effects.
Danish: Sædvanligvis gives 4 infusioner med otte ugers mellemrum, som dog kan øges til op til 16 uger, hvis patienten får svære bivirkninger.
English: In a main study of 229 patients with GEP-NETs that contained somatostatin receptors, patients given Lutathera lived for an average of 28 months without their disease getting worse.
Danish: I en hovedundersøgelse med 229 patienter med svulster af typen GEP-NET, der indeholdt somatostatinreceptorer, levede de patienter, der fik Lutathera, gennemsnitligt i 28 måneder uden forværring af sygdommen.
English: What is Lutathera and what is it used for?
Danish: Hvad er Lutathera, og hvad anvendes det til?
English: Because the number of patients with GEP-NETs is low, they are considered ‘rare', and Lutathera was designated an ‘orphan medicine' (a medicine used in rare diseases) on 31 January 2008.
Danish: Da antallet af patienter med svulster af typen GEP-NET er lavt, betragtes sygdommen som “sjælden”, og Lutathera blev udpeget som “lægemiddel til sjældne sygdomme” den 31. januar 2008.
English: The most common side effects seen with Lutathera treatment are nausea and vomiting, which occurred at the start of the infusions in around half of patients and may be related to the amino acid infusion.
Danish: De hyppigste bivirkninger, der ses ved behandling med Lutathera, er kvalme og opkastning, som forekom ved påbegyndelse af infusionerne hos omkring halvdelen af patienterne og kan have sammenhæng med infusionen af aminosyre.