natgillin/translations-raw huggingface dataset:
Hver INTELENCE- tablet indeholder 100 mg etravirin.
Each tablet of INTELENCE contains 100 mg of etravirine.
croscarmellosenatrium, magnesiumstearat og lactosemonohydrat.
croscarmellose sodium, magnesium stearate and lactose monohydrate.
INTELENCES udseende og pakningsstørrelse Ovale, hvide eller offwhite tabletter præget med "T125" på den ene side og "100" på den anden side.
What INTELENCE looks like and contents of the pack White to off-white, oval tablet, with “T125” on one side and “100” on the other side.
Et plasticglas indeholdende 120 tabletter og tre poser med tørremiddel, som holder tabletterne tørre.
A plastic bottle containing 120 tablets and 3 pouches to keep the tablets dry.
Indehaveren af markedsføringstilladelsen Janssen- Cilag International NV, Turnhoutseweg 30, B- 2340 Beerse, Belgien
Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Fremstiller Janssen- Cilag SpA, Via C.
Manufacturer Janssen-Cilag SpA, Via C.
Janssen, I- 04010 Borgo San Michele, Latina, Italien
Janssen, 0 4010 Borgo San Michele, Latina, Italy
34 Česká republika TIBOTEC, divize JANSSEN- CILAG s. r. o.
Česká republika TIBOTEC, divize JANSSEN-CILAG s.r.o.
Danmark TIBOTEC, en division af JANSSEN- CILAG A/ S Hammerbakken 19 DK- 3460 Birkerød Tlf.: +45 45 94 82 82
34 Danmark TIBOTEC, en division af JANSSEN-CILAG A/S Hammerbakken 19 DK-3460 Birkerød Tlf: +45 45 94 82 82
España JANSSEN- CILAG, S. A. división TIBOTEC Paseo de las Doce Estrellas, 5- 7 Campo de las Naciones E- 28042 Madrid Tel.: +34 91 722 81 00
España JANSSEN-CILAG, S.A. división TIBOTEC Paseo de las Doce Estrellas, 5-7 Campo de las Naciones E-28042 Madrid Tel: +34 91 722 81 00
35 Ísland TIBOTEC, deild hjá JANSSEN- CILAG c/ o Vistor hf.
35 Ísland TIBOTEC, deild hjá JANSSEN-CILAG c/o Vistor hf.
Denne indlægsseddel blev senest godkendt {MM/ ÅÅÅÅ}.
This leaflet was last approved in {MM/YYYY}.
Dette lægemiddel er godkendt med en ” betinget godkendelse ”.
This medicine has been given “conditional approval”.
Det betyder, at der kommer yderligere information om dette lægemiddel.
This means that there is more evidence to come about this medicine.
Det europæiske Lægemiddelagentur (EMEA) vil hvert år vurdere ny information vedrørende lægemidlet og vil om nødvendigt opdatere denne indlægsseddel.
The European Medicines Agency (EMEA) will review new information on the medicine every year and this leaflet will be updated as necessary.
Du kan finde yderligere information om dette lægemiddel på Det Europæiske Lægemiddelagenturs (EMEA' s) hjemmeside: http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Intrinsa anvendes til behandling af kvinder, som efter at have fået fjernet deres uterus (livmoder) og begge ovarier (æggestokke), når de har problemer med manglende seksuallyst og seksuelle tanker.
Intrinsa is used to treat women who have had their uterus (womb) and both ovaries removed, when they have a lack of sexual thoughts and sexual desire that is causing them distress.
Plastret sættes på tør, ren hud på den nederste del af abdomen (på maven under taljen).
The patch is applied to dry, clean skin on the lower abdomen (the tummy, below the waist).
Det kan vare længere end en måned, inden patienten oplever en forbedring.
It may take longer than a month for the patient to see an improvement.
En patient, der efter tre eller seks måneders behandling ikke får gavn af behandlingen, bør kontakte sin læge og få sin behandling revurderet.
If a patient is not getting a benefit after three to six months of treatment, she should contact her doctor and have her treatment reviewed.
Hos kvinder, som har fået fjernet deres livmoder og æggestokke, er den mængde testosteron, der produceres, halveret.
In women who have had their uterus and ovaries removed, the amount of testosterone produced is halved.
Intrinsa frigiver testosteron gennem huden ind i blodbanen for at opnå testosteronniveauer, der ligner niveauerne inden fjernelsen af livmoderen og æggestokkene.
Intrinsa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the uterus and ovaries.
De to hovedundersøgelser omfattede 1 095 kvinder med en gennemsnitsalder på 49 år, som havde havde fået Intrinsa i op til et år.
Intrinsa was compared with placebo (a patch containing no active substance).
Intrinsa blev sammenlignet med placebo (et plaster, som intet aktivt stof 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged indeholder).
Reproduction is authorised provided the source is acknowledged. sexual episodes in a four-week period.
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 sammenligning med de kvinder der fik placebo over en fireugers periode.
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.
Dette betyder i gennemsnit, at kvinder, der inden behandlingen gennemsnitligt 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.
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.
De mest almindelige bivirkninger ved Intrinsa (set hos flere end 1 ud af 10 patienter) var hirsutisme (øget hårvækst, navnlig på hage og overlæben) og reaktioner på det sted, hvor plastret blev sat på (rødme, og kløe).
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).
Den fuldstændige liste over alle de indberettede bivirkninger ved Intrinsa fremgår af indlægssedlen.
For the full list of all side effects reported with Intrinsa, see the Package Leaflet.
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, hårtab.
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.
Intrinsa bør ikke anvendes af personer, som kan være overfølsomme (allergiske) over for testosteron eller et af de øvrige indholdsstoffer.
Intrinsa should not be used in people who may be hypersensitive (allergic) to testosterone or any of the other ingredients.
Det bør heller ikke anvendes af kvinder der har, eller har haft, brystkræft eller andre østrogenkrævende kræfttyper, eller af kvinder der har andre tilstande, der gør at de ikke kan tage østrogenholdige lægemidler.
It should also 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.
Kvinder, der anvender Intrinsa, bør også tage østrogener, men ikke af den type, der er kendt som ‘ konjugerede østrogener ’, da denne kombination ikke er lige så effektiv.
Women using Intrinsa should also use oestrogens, but not of the type known as ‘ conjugated oestrogens ’ as this combination is not as effective.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at konkluderede, at fordelene ved Intrinsa opvejede risiciene til afhjælpning af symptomerne på hypoaktiv seksuallyst hos kvinder, der havde fået fjernet deres uterus og begge ovarier, og som samtidig modtog østrogenbehandling.
The Committee for Medicinal Products for Human Use (CHMP) decided that Intrinsa’ s benefits are greater than its risks for the treatment of hypoactive sexual desire disorder in bilaterally oophorectomised and hysterectomised women receiving concomitant oestrogen therapy.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Intrinsa.
The Committee recommended that Intrinsa be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Intrinsa?
Which measures are being taken to ensure the safe use of Intrinsa?
Firmaet, som fremstiller Intrinsa, skal nøje overvåge nogle af bivirkningerne fra Intrinsa såsom de androgene bivirkninger.
The company that makes Intrinsa will monitor some of the side effects of Intrinsa closely, such as androgenic side effects.
Det skal gennemgå alle igangværende undersøgelser med Intrinsa for at se på de potentielle langsigtede risici, herunder brystkræft, endometriecancer (kræft i livmoderen) og bivirkninger, der påvirker hjertet og blodkarrene.
The company will review all 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.
Det skal udvikle en undervisningsplan for både læger og patienter.
The company will also provide an educational plan for doctors and patients.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Intrinsa til Procter & Gamble Pharmaceuticals UK Ltd den 28. juli 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Intrinsa to Procter & Gamble Pharmaceuticals UK Ltd. on 28 July 2006.
300 mikrogram/ 24 timer
300 micrograms/ 24 hours
Brev (papir/ PET/ alu/ ethylen methacrylsyre copolymer)
sachet (paper/ PE/ Alu/ ethylene methacrylic acid copolymer)
2 depotplastre
2 patches
8 depotplastre
8 patches
24 depotplastre
24 patches
Intrinsa 300 mikrogram/ 24 timer depotplaster
Intrinsa 300 micrograms/ 24 hours transdermal patch
Hvert plaster på 28 cm2 indeholder 8, 4 mg testosteron og afgiver 300 mikrogram testosteron på 24 timer.
Each patch of 28 cm2 contains 8.4 mg testosterone and provides 300 micrograms of testosterone per 24 hours.
Tyndt, gennemsigtigt, ovalt depotplaster af matrixtypen, bestående af tre lag: et gennemsigtigt bagsidelag, et klæbende matrixlag med lægemiddel og en b eskyttelsesfilm, som fjernes før brug.
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.
Overfladen på hvert plaster er påtrykt PG T001.
Each patch surface is stamped with PG T001.
Det anbefales at benytte et hudområde, som har mindst mulige rynker, og som ikke er dækket af tæt siddende tøj.
A skin site with minimal wrinkling and not covered by tight clothing is recommended.
Samtidig østrogenbehandling Relevant brug af og restriktioner forbundet med østrogenbehandling bør overvejes, før behandlingen med Intrinsa indledes og ved rutinemæssig revurdering af behandlingen.
Concomitant estrogen treatment The appropriate use and restrictions associated with estrogen therapy should be considered before Intrinsa therapy is initiated and during routine re-evaluation of treatment.
F ortsat anvendelse af Intrinsa anbefales kun, mens samtidig brug af østrogen menes at være relevant (dvs. den laveste, effektive dosis i kortest mulige tid).
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).
4. 4 og 5. 1).
2 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).
Varighed af behandlingen Respons på behandlingen med Intrinsa bør vurderes inden for 3 - 6 måneder efter behandlingsstart for at afgøre, om det er relevant at fort sætte behandlingen.
Duration of treatment Intrinsa treatment response should be evaluated within 3-6 months of initiation, to determine if continued therapy is appropriate.
Da effekten og sikkerheden af Intrinsa ikke er blevet vurderet i forsøg af længere varighed end 1 år, anbefales det at foretage en vurdering af behandlingen hver 6. måned.
As the efficacy and safety of Intrinsa have not been evaluated in studies of longer duration than 1 year, it is recommended that an appraisal of the treatment is undertaken every 6 months.
Der ingen relevant indikation for brug af Intrinsa hos børn og unge.
There is no relevant indication for use of Intrinsa in children and adolescents.
En hvilken som helst anden tilstand, som svarer til kontraindikationerne for brug af østrogen.
Known, suspected or past history of cancer of the breast or known or suspected estrogen-dependent neoplasia, or any other condition consistent with the contraindications for the use of estrogen.
Med regelmæssige mellemrum under behandlingen bør læger monitorere patienter for potentielle, androgene bivirkninger (f. eks. acne, ændringer i hårvækst eller hårtab).
At regular intervals during treatment, physicians should monitor patients for potential androgenic undesirable effects (e. g. acne, changes in hair growth or hair loss).
Patienterne bør rådes til også selv at vurdere, om de får uønskede andr ogene bivirkninger.
Patients should be advised to self assess for androgenic undesirable effects.
4. 8).
In clinical trials these reactions were reversible in the majority of patients (see section 4.8).
Intrinsas sikkerhed er ikke vurderet i dob beltblinde, placebokontrollerede forsøg med længere varighed end 1 år.
The safety of Intrinsa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration.
Data i litteraturen vedrørende test osterons indflydelse på risikoen for brystcancer hos kvinder er begrænsede, de giver intet klart billede og er modstridende.
Data in the literature regarding the influence of testosterone on the risk of breast cancer in women are limited, inconclusive and conflicting.
Derfor bør patienterne monitoreres omhyggeligt for bry stkræft i overensstemmelse med den aktuelt accepterede screeningpraksis og den enkelte patients behov.
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.
Monitoreringen bør især være rettet mod ændringer i blodtryk og vægt.
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.
Hos diabetespatienter kan testosterons metaboliske virkning nedsætte b lodglukose og dermed behovet for insulin.
In diabetic patients the metabolic effects of testosterone may decrease blood glucose and therefore insulin requirements.
Ødem (med eller uden kongestiv hjerteinsufficiens) kan være en alvorlig komplikation af høje doser af testosteron eller andre anabole steroider hos patienter med eksisterende hjerte -, nyre - eller leversygdom.
Oedema (with or without congestive heart failure) may be a serious complication from high doses of testosterone or other anabolic steroids in patients with pre-existing cardiac, renal, or hepatic disease.
Dette forventes dog ikke ved den lave dosis testosteron, Intrinsa - plastret afgiver.
However, this is not expected from the low dose of testosterone delivered by the Intrinsa patch.
3 Intrinsa anbefales til brug hos kirurgisk menopausale kvinder op til 60 år.
3 Intrinsa is recommended for use in surgically menopausal women up to the age of 60.
Effekt og sikkerhed af Intrinsa 300 mikrogram hos naturligt menopausale kvinder med HSDD i samtidig østrogenbehandling med eller uden progestogen er i kke undersøgt.
Efficacy and safety of Intrinsa 300 micrograms in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated.
Derfor anbefales Intrinsa 300 mikrogram ikke til naturligt menopausale kvinder.
Intrinsa 300 micrograms is not recommended in naturally menopausal women.
4. 2 og 5. 1).
Therefore, Intrinsa should not be used in women on concomitant CEE (see sections 4.2 and 5.1).
Androgener kan nedsætte niveauet af thyroxin- bindende globulin, hvilket giver lavere totale T4- serumniveauer og øget optagelse af T3 - og T4- resin.
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4.
Patienter, som får orale antikoagulantia, skal monitoreres tæt, især når testosteronbehandlingen indledes eller sep oneres.
Patients receiving oral anticoagulants require close monitoring, especially when testosterone therapy is started or stopped.
Intrinsa må ikke anvendes til kvinder, som er eller kan blive gravide eller til kvinder, som ammer.
Intrinsa must not be used in women who are or may become pregnant or by breast-feeding women.
Intrinsa har ingen indflydelse på evnen til at føre bil eller betjene maskiner.
Intrinsa has no influence on the ability to drive and use machines.
Den hyppigst rapporterede bivirkning (30, 4%) var reaktioner på applikationsstedet.
The adverse reaction most often reported (30.4%) was application site reactions.
De fleste rapporter, der drejede sig om hagen og overlæben, var milde (≥ 90%), og mindre end 1% af alle patienter trak sig ud af forsøget på grund af hirsutisme.
Most reports concerned the chin and upper lip, were mild (≥ 90%), and less than 1% of all patients withdrew from the studies due to hirsutism.
Andre androgene effekter, som almindeligvis blev rapporteret var acne, dybere stemme og alopeci.
Other androgenic effects commonly reported were acne, voice deepening and alopecia.
Mere end 90% af disse rapporter blev anset som milde.
More than 90% of these reports were considered mild.
Mindre end 1% trak sig ud af forsøget på grund af nogle af disse reaktioner.
Less than 1% of patients withdrew from the studies because of any of these reactions.
Alle andre almindelige uønskede hændelser gik over hos de fleste patienter.
All other common adverse events resolved in the majority of patients.
Under den 6- måneders dobbeltblinde anvendelse forekom følgende bivirkninger i behandlingsgruppen (n=549) med større incidens end i placebogruppen (n=545).
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.
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.
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.
4 MedDRA
4 MedDRA
Meget almindelig
Very
≥ 1/ 1. 000, < 1/ 100
≥ 1/ 1,000, < 1/ 100
Infektiøse og parasitære sygdomme
Infections and infestations Blood and lymphatic system disorders
Forstyrrelser i immunsystemet Stofskiftesygdomme og ernæringsbetingede sygdomme
Immune system disorders Metabolism and nutrition disorders
Overfølsomhed Øget appetit
Hypersensitivity Increased appetite
Psykiske lidelser Sygdomme i nervesystemet
Psychiatric disorders Nervous system disorders
Søvnløshed Migræne
Insomnia Migraine
Ophidselse, angst Opmærksomhedsforstyrrelse, dysgeusi, nedsat balance, hyperæstesi, oral paræstesi, forbigående iskæmisk anfald
Agitation, anxiety Disturbance in attention, dysgeusia, impaired balance, hyperaesthesia, oral paraesthesia, transient ischemic attack
Øjensygdomme Hjertesygdomme
Eye disorders Cardiac disorders
Dobbeltsyn, røde øjne Hjertebanken
Diplopia, eye redness Palpitations
Sygdomme i åndedrætsorganer, brysthule og mediastinum Gastrointestinale sygdomme
Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders
Dybere stemme Mavesmerter
Voice deepening Abdominal pain
Tæthed i næsen, tæthed i struben Diaré, mundtørhed, kvalme
Nasal congestion, throat tightness Diarrhoea, dry mouth, nausea
Sygdomme i hud og subkutane væv Sygdomme i bevægeapparatet og bindevæv
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders
Acne, alopeci
Acnes, alopecias
Eksem, øget svedafsondring, rosacea Artritis
Eczema, increased sweating, rosacea Arthritis
Vægtforøgelse
Increased weight
Unormalt fibrinogen i blodet, øget hjerterytme, forhøjet alanin- aminotransferase, forhøjet aspartat - aminotransferase, forhøjet bilirubin i blodet, unormal leverfunktionstest, forhøjede triglycerider i blodet
Abnormal blood fibrinogen, increased heart rate, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides
Der blev ikke identificeret nye eller andre bivirkninger fra det spontane post - marketing system.
No new or other adverse reactions have been identified from the post-marketing spontaneous reporting system.
5. 2).
Removal of the patch results in a rapid decrease in serum testosterone levels (see section 5.2).
Androgener, testosteron, ATC- kode:
Androgens, testosterone, ATC code:
Testosteron, det vigtigste cirkulerende androgen hos kvinder, er et naturligt forekommende steroid, som udskilles af ovarierne og binyrerne.
5 Testosterone, the primary circulating androgen in women, is a naturally occurring steroid, secreted by the ovaries and adrenal glands.
5 100- 400 mikrogram/ 24 timer, hvoraf halvdelen stammer fra ovarierne som enten testosteron eller en prækursor.
In premenopausal women, the rate of production of testosterone is 100 to 400 micrograms/ 24 hours, of which half is contributed by the ovary as either testosterone or a precursor.
Hos kvinder, som har fået begge æggestokke fjernet, falder serumniveauet af testosteron med cirka 50% få dage efter indgre bet.
In women, who have undergone bilateral oophorectomy, serum levels of testosterone decline by approximately 50% within days after surgery.
To multicenter, dobbeltblinde, placebokontrollerede forsøg af seks måneders varighe d 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.
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.
I den kombinerede forsøgsanalyse ved uge 24 var forskellen i gennemsnitshyppigheden a f fuldstændig tilfredsstillende episoder mellem Intrinsa og placebo på 1, 07 per 4 uger.
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.
En respondent var prædefineret til at have en stigning i 4 - ugers- frekvensen af tilfredsstillende aktiviteter på > 1.
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.
Der sås effekt af Intrinsa ved 4 uger efter behandlingsstart (først målte tidspunkt) og ved alle månedlige effekt- tidspunkter derefter.
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.