FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately: - if you experience hair loss (a common side effect which may affect up to 1 in 10 people), enlargement of the clitoris (an uncommon side effect which may affect up to 1 in 100 people), an increase in the amount of hair on the chin or upper lip (a very common side effect which may affect more than 1 in 10 people), voice deepening or hoarseness (a common side effect), although these side effects may be mild.
Danish: Fortæl det omgående til lægen: - hvis De oplever hårtab (en almindelig bivirkning, som kan forekomme hos op til 1 ud af 1 personer), forstørrelse af klitoris (en ikke almindelig bivirkning, som kan forekomme hos op til 1 ud af 100 personer), øget hårvækst på hage eller overlæbe (en meget almindelig bivirkning, som kan forekomme hos mere end 1 ud af 10 personer), dybere stemme eller hæshed (en almindelig bivirkning), selvom disse bivirkninger kan være milde.
English: If the same patch cannot be reapplied, a new patch should be applied to another location.
Danish: Hvis samme plaster ikke kan bruges igen, skal et nyt plaster sættes på et andet sted.
English: However, the subgroup of patients receiving oral CEE did not demonstrate a significant improvement in sexual activity compared to placebo (see sections 4.2 and 4.4).
Danish: Imidlertid udviste den undergruppe af patienter, som fik oral CEE, ikke signifikant forbedret seksuel aktivitet sammenlignet med placebo (se pkt.
English: Little information is available on the effects of testosterone on the endometrium.
Danish: Der foreligger kun få oplysninger om testosterons virkning på endometriet.
English: Livensa is recommended for use in surgically menopausal women up to the age of 60.
Danish: Livensa anbefales til brug hos kirurgisk menopausale kvinder op til 60 år.
English: The active substance is testosterone.
Danish: Aktivt stof: Testosteron.
English: A significantly higher percentage of women who received Livensa 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 Livensa, end de kvinder, som fik placebo, rapporterede en fordel i de tre endpoints, som kvinderne betragtede som klinisk betydningsfulde.
English: Data in the literature regarding the influence of testosterone on the risk of breast cancer in women are limited, inconclusive and conflicting.
Danish: Data i litteraturen vedrørende testosterons indflydelse på risikoen for brystcancer hos kvinder er begrænsede, de giver intet klart billede og er modstridende.
English: If you stop estrogen therapy you must also stop using Livensa.
Danish: Hvis De holder op med østrogenbehandlingen, skal De også holde op med at anvende Livensa.
English: Hirsutism Acne, alopecia Eczema, increased sweating, rosacea
Danish: Acne, alopeci Eksem, øget svedafsondring, rosacea
English: Continue your treatment for as long as your doctor
Danish: Fortsæt behandlingen, så længe lægen tilråder det.
English: Date of latest renewal: 28-July-2011
Danish: Dato for første markedsføringstilladelse: 28. juli 2006 Dato for seneste fornyelse: 28. juli 2011
English: Livensa is a transdermal patch which constantly releases small amounts of testosterone that is absorbed through your skin into the bloodstream.
Danish: Livensa er et depotplaster, som konstant afgiver små mængder testosteron, som absorberes i blodet igennem huden.
English: Step 2 While holding the patch, remove half of the protective liner that covers the sticky part of the patch.
Danish: Trin 2 Mens De holder plastret, fjerner De den ene halvdel af den beskyttelsesfilm, som dækker den klæbende side af plastret.
English: Testosterone has a masculinising effect on female rat foetuses when dosed subcutaneously at 0.5 or 1 mg/day (as the propionate ester) to pregnant rats during organogenesis.
Danish: Testosteron har en maskuliniserende virkning på hunrottefostre, når det administreres i en subkutan dosis på 0,5 eller 1 mg/dag (som propionat ester) til drægtige rotter under organogenesen.
English: Each patch is sealed in a sachet.
Danish: Hvert plaster er forseglet i et brev.
English: Fertility No data is available of the effect of Livensa on fertility.
Danish: Fertilitet Der er ingen data for virkningen af Livensa på fertilitet
English: DHT concentrations increased in parallel with testosterone concentrations during Livensa treatment.
Danish: DHT-koncentrationerne steg parallelt med testosteronkoncentrationerne under behandlingen med Livensa.
English: This is achieved by applying the patch twice weekly on a continuous basis.
Danish: Dosis opnås ved vedvarende applicering af plastret to gange ugentligt.
English: In case of severe application site reaction, the treatment should
Danish: Hvis der forekommer svære reaktioner på applikationsstedet, bør behandlingen ophøre.
English: Each patch is packed in a sealed laminated sachet.
Danish: Hvert plaster ligger i et forseglet, lamineret brev.
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 Livensa.
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 Livensa.
English: However, this is not expected from the low dose of testosterone delivered by the Livensa patch.
Danish: Dette forventes dog ikke ved den lave dosis testosteron, Livensa-plastret afgiver.
English: Livensa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones.
Danish: Livensa påvirkede ikke serumkoncentrationerne af sexhormonbindende globulin (SHBG), østrogener eller binyrehormoner.
English: After removal of the ovaries, testosterone drops to half of the levels compared to before the operation.
Danish: Efter at æggestokkene er fjernet, falder testosteronniveauet til det halve i sammenligning med niveauet før indgrebet.
English: The sachet material comprises of food grade paper/LDPE/aluminium foil/ethylene methacrylic acid copolymer (outer to inner layer).
Danish: Brevet er fremstillet af fødevaregodkendt papir/LDPE/aluminiumfolie/ethylen methakrylsyre copolymer (ydre til indre lag).
English: Use your fingers to make sure the edges of the patch stick to the skin.
Danish: Kontroller med fingrene, at plastrets kanter klæber til huden.
English: Livensa is designed to systemically deliver 300 micrograms/day.
Danish: Livensa er udviklet til systemisk udskillelse af 300 mikrogram/dag.
English: In clinical trials these reactions were reversible in the majority of patients (see section 4.8).
Danish: I kliniske forsøg var disse reaktioner reversible hos størstedelen af patienterne (se pkt.
English: Subgroup analyses suggested that the route and type of concomitant estrogen (transdermal oestradiol, oral conjugated equine estrogen (CEE), oral non-CEE) can influence patient response.
Danish: Analyser af undergrupper tyder på, at indgivelsesvejen og typen af samtidig østrogenbehandling (transdermal østradiol, oralt konjugeret ekvint østrogen (CEE), oralt ikke-CEE) kan påvirke patientens respons.
English: How and when to change your patch - You will need to change your patch every 3 to 4 days, which means using two patches each week.
Danish: Sådan og på dette tidspunkt skiftes plasteret - Plastret skal skiftes hver 3. eller 4. dag, hvilket betyder, at De skal anvende to plastre om ugen.
English: Testosterone is mainly excreted in the urine as glucuronic and sulphuric acid conjugates of testosterone and its metabolites.
Danish: Testosteron udskilles primært i urinen som glucuronsyre- og svovlsyrekonjugater af testosteron og dets metabolitter.
English: If a patch does begin to come off, you may be able to make it stick again by pressing on it firmly.
Danish: Hvis et plaster begynder at løsne sig, kan De få det til at sidde fast igen ved at presse det fast mod huden.
English: - If you are also using estrogen patches, make sure that the Livensa patch and the estrogen patch do not overlap.
Danish: - Hvis De også anvender østrogenplastre, skal De sørge for, at Livensa-plastret og østrogenplastret ikke overlapper hinanden.
English: The ethylene methacrylic acid copolymer (Surlyn) is the heat seal layer which allows the two laminate sachet stocks to be heat-sealed together to form the sachet.
Danish: Ethylen methakrylsyre copolymer (Surlyn) danner varme-forseglingslaget, som gør, at brevets to laminerede materialestykker kan varmeforsegles sammen, hvorved de danner et brev.
English: However, do not scrub the area where the patch has been placed too hard.
Danish: De bør imidlertid ikke gnubbe for hårdt på stedet, hvor plastret sidder.
English: The long-term effect of testosterone treatment on the breast is currently unknown, therefore patients should be carefully monitored with regard to breast cancer in accordance with currently accepted screening practises and individual patient needs.
Danish: Derfor bør patienterne monitoreres omhyggeligt for brystkræft i overensstemmelse med den aktuelt accepterede screeningpraksis og den enkelte patients behov.
English: Do not use scissors as you may accidentally damage the patch.
Danish: Brug ikke saks, da De kan komme til at beskadige plastret.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Apply immediately upon removal from the sachet.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Påsættes straks efter, at depotplastret er taget ud af brevet.
English: Livensa 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: Livensa 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: Livensa should not be used in naturally menopausal women Efficacy and safety of Livensa in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated.
Danish: Livensa må ikke anvendes til naturligt menopausale kvinder Effekt og sikkerhed af Livensa hos naturligt menopausale kvinder med HSDD i samtidig østrogenbehandling med eller uden progestogen er ikke undersøgt.
English: Change your patch as soon as you remember, and then continue with your regular schedule of patchchange days, even if this means discarding a patch after you have worn it for less than 3-4 days.
Danish: Skift plastret, så snart De kommer i tanke om det, og fortsæt så efter det normale skema med dage, hvor der skiftes plaster, selvom det betyder, at De må kassere et plaster, De har gået med i mindre end 3-4 dage.
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 Livensa.
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 Livensa.
English: To prevent interference with the adhesive properties of Livensa, no creams, lotions or powder should be applied to the skin where the patch is to be applied.
Danish: For at forhindre, at Livensas klæbeevne påvirkes, bør der ikke benyttes creme, lotion eller talkum på det hudområde, hvor plastret skal sidde.
English: - if you have cancer of the lining of the womb (endometrial cancer), be aware that there is little information available on the effects of testosterone on the lining of the womb (endometrium).
Danish: - hvis De har kræft i livmoderslimhinden (endometriecancer) skal De være klar over, at der kun er en lille mængde tilgængeligt information om testosterons virkning på livmoderslimhinden (endometriet).
English: Endometrial effects
Danish: Virkninger på endometriet
English: If you cannot get the patch to stick successfully, remove the loose patch and use a new patch.
Danish: Hvis De ikke kan få plastret til at sidde fast, skal De fjerne det løse plaster og bruge et nyt plaster.
English: The following pack sizes are available: 2, 8 and 24 patches.
Danish: Det fås i følgende pakningsstørrelser: 2, 8 og 24 plastre.
English: Testosterone is metabolised primarily in the liver.
Danish: Testosteron metaboliseres primært i leveren.
English: The limited data evaluating the effect of testosterone on the endometrium neither allow conclusions nor reassurances on the incidence of endometrial cancer.
Danish: De begrænsede data, som vurderer effekten af testosteron på endometriet, gør det hverken muligt at drage konklusioner af nogen art eller komme med beroligende udsagn om incidencen af endometriecancer.
English: Overdosing with Livensa is unlikely when used as directed, because once the patch is taken off testosterone is quickly removed by the body.
Danish: Overdosering med Livensa er usandsynlig, når det anvendes efter instruktionerne, fordi testosteronen hurtigt udskilles af kroppen, når plastret tages af.
English: Thin, clear, oval matrix-type transdermal patch consisting of three layers: a translucent backing film, an adhesive matrix drug layer, and a protective release liner that is removed prior to application.
Danish: Tyndt, gennemsigtigt, ovalt depotplaster af matrixtypen, bestående af tre lag: et gennemsigtigt bagsidelag, et klæbende matrixlag med lægemiddel og en beskyttelsesfilm, som fjernes før brug.
English: Take special care with Livensa - if you have a history of heart, liver or kidney disease.
Danish: Vær ekstra forsigtig med at bruge Livensa - hvis De har eller har haft sygdomme i hjerte, lever eller nyrer.
English: The medical term for this condition is Hypoactive Sexual Desire Disorder, also known as
Danish: Den medicinske betegnelse for denne tilstand er hypoaktiv seksuel lyst, også kaldet HSDD.
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 Livensa 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 Livensa-plastret.
English: Livensa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels.
Danish: Livensa er en transdermal behandling af HSDD, som øger kvindens seksuelle lyst, idet der opnås testosteronkoncentrationer, som svarer til det præmenopausale niveau.
English: Then continue with your regular schedule of patch-change days, even if this means discarding a patch after you have worn it for less than 3-4 days.
Danish: Fortsæt derefter efter det normale skema med dage, hvor der skiftes plaster, selvom det betyder, at De må kassere et plaster, De har gået med i mindre end 3-4 dage.
English: The efficacy of Livensa is reduced if your estrogen therapy is of a certain type (‘conjugated equine estrogens').
Danish: Virkningen af Livensa reduceres, hvis De bliver behandlet med østrogen af en bestemt type (‘konjugerede ekvine østrogener').
English: In women, who have undergone bilateral oophorectomy, serum levels of testosterone decline by approximately 50 % within days after surgery.
Danish: Hos kvinder, som har fået begge æggestokke fjernet, falder serumniveauet af testosteron med cirka 50% få dage efter indgrebet.
English: If the patch detaches prematurely, it may be reapplied.
Danish: Hvis plastret løsner sig for tidligt, kan det sættes på igen.
English: Testosterone, the primary circulating androgen in women, is a naturally occurring steroid, secreted by the ovaries and adrenal glands.
Danish: Testosteron, det vigtigste cirkulerende androgen hos kvinder, er et naturligt forekommende steroid, som udskilles af ovarierne og binyrerne.
English: - sinusitis (inflammation of nasal sinus) - abnormal clotting factor - hypersensitivity (allergic reactions) - increased appetite - agitation
Danish: - sinuitis (betændelse i næsens bihuler) - unormal blodstørkningsfaktor - overfølsomhed (allergiske reaktioner) - forøget appetit - ophidselse - angst - opmærksomhedsforstyrrelse
English: Remove the patch.
Danish: Tag plastret ud.
English: Therefore, Livensa should not be used in women on concomitant CEE (see sections 4.2 and
Danish: Derfor bør Livensa ikke anvendes til kvinder i samtidig behandling med CEE (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: Patients with cardiovascular risk factors, in particular hypertension, and patients with known cardiovascular disease should be carefully monitored, specifically regarding changes in blood pressure and weight.
Danish: Patienter med kardiovaskulære risikofaktorer, især hypertension, og patienter, hos hvem der er kendskab til kardiovaskulær sygdom, bør monitoreres omhyggeligt.
English: Serum concentrations of testosterone and SHBG in patients receiving Livensa in clinical safety and
Danish: Serumkoncentrationer af testosteron og SHBG hos patienter, som fik Livensa i kliniske sikkerheds-/ og effektforsøg.
English: What Livensa looks like and contents of the pack Livensa is a thin, clear, oval patch with T001 stamped on the back.
Danish: Livensa er et tyndt, klart, ovalt plaster med T001 trykt på bagsiden.
English: Press the entire patch firmly against your skin with the palm of your hand for about 10 seconds.
Danish: Hele plastret presses fast på huden med håndfladen i ca. 10 sekunder.
English: Livensa is only indicated for women in their menopause after the ovaries and uterus have been removed.
Danish: Livensa er kun beregnet til kvinder i menopausen, efter at de har fået fjernet æggestokkene og livmoderen.
English: 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: A skin site with minimal wrinkling and not covered by tight clothing is recommended.
Danish: Det anbefales at benytte et hudområde, som har mindst mulige rynker, og som ikke er dækket af tætsiddende tøj.
English: Livensa should not be used in women on concomitant CEE Whereas Livensa 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: Livensa må ikke anvendes til kvinder med samtidig CEE Mens Livensa 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: The used patch should be folded in half, sticking the patch to itself, and discarded in a safe way in order to keep it away from children (e.g in a rubbish bin).
Danish: Det brugte depotplaster skal foldes på midten, så plastret klæbes sammen, og bortskaffes på en sikker måde for at holde det væk fra børn (f.eks. i en papirkurv).
English: - For at least one week after removing a patch, do not place a new patch in the same area.
Danish: - Når De har taget et plaster af, skal der gå mindst en uge, inden De må sætte et nyt plaster på samme sted.
English: - When changing your patch, stick the new patch on to a different area of the skin of your abdomen, otherwise you are more likely to cause skin irritation.
Danish: - Når De skifter plastret, skal De sørge for at sætte plastret et nyt sted på maven, da der ellers er større sandsynlighed for, at der opstår hudirritation.
English: All other common adverse reactions resolved in the majority of patients.
Danish: Alle andre almindelige bivirkninger gik over hos de fleste patienter.
English: The albumin-bound fraction and the unbound fraction are collectively termed ‘bioavailable' testosterone.
Danish: Den albuminbundne fraktion og den ubundne fraktion betegnes samlet ‘biotilgængelig' testosteron.
English: PHARMACEUTICAL FORM AND CONTENTS 2 transdermal patches
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 2 depotplastre
English: - if you notice any skin reactions at the site of application (a very common side effect) such as redness, oedema, or blistering.
Danish: - hvis De bemærker hudreaktioner på applikationsstedet (det vil sige, dér, hvor De har sat plastret fast) (en meget almindelig bivirkning), som f.eks. rødme, hævelse eller blærer.
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, androgens, ATC
Danish: Farmakoterapeutisk klassifikation: Kønshormoner og modulatorer for det genitale system, androgener, ATC-kode: G03BA03
English: They are usually reversible if Livensa treatment is
Danish: De kan som regel afhjælpes, hvis behandlingen med Livensa ophører.
English: Agitation, anxiety
Danish: Søvnløshed Ophidselse, angst
English: Do not use Livensa in case of breast-feeding because it may cause harm to the child.
Danish: Anvend ikke Livensa, hvis De ammer, da dette kan skade barnet.
English: Serum concentrations of testosterone attain steady-state by the application of the second patch when applied in a twice-a-week regimen.
Danish: Serumkoncentrationer af testosteron når steady state ved applikationen af det andet plaster i et behandlingsregime med to plastre ugentligt.
English: Patches should not be applied to the breasts or other body regions.
Danish: Plastret bør ikke sættes på brysterne eller andre områder på kroppen.
English: Patients with known cardiovascular disease have not been studied.
Danish: Patienter, hos hvem der var kendskab til kardiovaskulær sygdom, har ikke været genstand for undersøgelser.
English: A particular application site should be rotated with an interval of at least 7 days between applications.
Danish: Der bør være et interval på mindst 7 dage imellem placering på samme sted.
English: Always use Livensa exactly as your doctor has told you.
Danish: LivensBrug altid Livensa nøjagtigt efter lægens anvisning.
English: Step 4 Fold back the patch and carefully remove the other half of the liner.
Danish: Trin 4 Fold den anden halvdel af plasteret tilbage og fjern den anden halvdel af beskyttelsesfilmen.
English: Other common side effects Most of them are mild in nature and reversible.
Danish: Andre almindelige bivirkninger De fleste af dem er milde og kan afhjælpes.
English: Step 3 Apply the sticky side of the patch to the selected area onto your skin.
Danish: Trin 3 Sæt den klæbende side af plasteret på det valgte hudområde.
English: The adhesive side of the patch should be applied to a clean, dry area of skin on the lower abdomen below the waist.
Danish: Plastrets klæbende side skal anbringes på et tørt og rent hudområde på maven under taljen.
English: Serum concentration of SHBG is influenced by the route of administration of concomitant estrogen therapy.
Danish: Serumkoncentrationen af SHBG påvirkes af indgivelsesvejen for den samtidige østrogenbehandling.
English: Livensa 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: Livensa 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: 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 Livensa treatment.
Danish: Under den 6-måneders dobbeltblinde anvendelse forekom følgende bivirkninger i behandlingsgruppen (n=549) med større incidens end i placebogruppen (n=545).