FrancophonIA/ELRC3.0 huggingface dataset:
English: • Data from two phase III trials (study no. A07062 and A28501) in a total of around 2,400 women (mostly with moderate acne) showed that dienogest/ethinylestradiol was more effective than placebo and at least as effective as ethinylestradiol/norgestimate and ethinylestradiol/cyproterone at treating acne in terms of changes in inflammatory lesion count, total lesion count and improvement of facial acne according to IGA (Investigator's Global Assessment).
Danish: • Data fra to fase III-undersøgelser (undersøgelse nr. A07062 og A28501) hos i alt ca. 2 400 kvinder (primært med moderat akne) viste, at dienogest/ethinyløstradiol var mere effektivt end placebo og mindst lige så effektivt som ethinyløstradiol/norgestimat og ethinyløstradiol/cyproteron til behandling af akne i form af reduktion af antallet af inflammatoriske læsioner, reduktion af det samlede antal aknelæsioner og bedring af akne i ansigtet i henhold til investigators overordnede vurdering (IGA).
English: Your doctor will assess whether you should continue treatment with this medicine 3 to 6 months after you have started treatment and regularly after that.
Danish: Din læge vil vurdere, om du skal fortsætte behandlingen med dette lægemiddel 3-6 måneder efter behandlingsstart og med jævne mellemrum derefter.
English: • Your acne will usually improve after 3 to 6 months of treatment with dienogest/ethinylestradiol.
Danish: • Din akne vil normalt bedres efter 3-6 måneders behandling med dienogest/ethinyløstradiol.
English: The known risk of venous thromboembolism (VTE or blood clots in veins), which can occur with all combined hormonal contraceptives, is considered low.
Danish: Den kendte risiko for venøs tromboemboli (VTE/blodpropper i venerne), der kan forekomme ved alle kombinerede hormonelle præventionsmidler, vurderes at være lav.
English: • Since improvement of acne usually requires at least 3 months of treatment with dienogest/ethinylestradiol and further improvement has been seen after 6 months, women should be assessed 3 to 6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
Danish: • Da en bedring af akne normalt kræver mindst 3 måneders behandling med dienogest/ethinyløstradiol, og da yderligere bedring er set efter 6 måneders behandling, bør kvinderne vurderes 3-6 måneder efter behandlingsstart og med jævne mellemrum derefter for at revidere behovet for fortsat behandling.
English: • It is not known how the efficacy of dienogest/ethinylestradiol compares with other acne treatments, i.e. topical treatments and systemic antibiotics.
Danish: • Det vides ikke, hvor effektivt dienogest/ethinyløstradiol er sammenholdt med andre aknebehandlinger som f.eks. topiske midler og systemiske antibiotika.
English: The review of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg for acne was initiated on 25 February 2016 at the request of the UK's medicines agency (the Medicines and Healthcare products Regulatory Agency, MHRA), under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler mod akne, der indeholder dienogest 2 mg og ethinyløstradiol 0,03 mg, blev igangsat den 25. februar 2016 på anmodning fra den britiske lægemiddelstyrelse (MHRA), jf. artikel 31 i direktiv 2001/83/EF.
English: Having evaluated the existing data on the effectiveness of the combination in the treatment of acne, EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that there is sufficient evidence to support its use in moderate acne.
Danish: Efter at have gennemgået de eksisterende data om virkningen af disse kombinationslægemidler til behandling af akne har EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderet, at der foreligger tilstrækkelig evidens til at understøtte, at de anvendes til behandling af moderat akne.
English: The CHMP also recommended that women should be assessed by their doctor 3 to 6 months after starting treatment and periodically thereafter to review the need for continuation of treatment.
Danish: CHMP anbefaler også, at kvinderne skal lægeundersøges 36 måneder efter behandlingsstart og med jævne mellemrum derefter for at revurdere behovet for fortsat behandling.
English: However, these medicines, which are also approved as hormonal contraceptives, should only be used in women who choose oral contraception.
Danish: Disse kombinationslægemidler, der også er godkendt som hormonel prævention, bør dog kun anvendes af kvinder, der har valgt at bruge p-piller.
English: Considering the observed benefits of dienogest/ethinylestradiol in the treatment of acne, the potential risk of VTE and the nature of the disease, the CHMP concluded that this combination should only be used after certain other treatments have failed, and only when oral contraception is chosen.
Danish: På baggrund af de observerede fordele ved dienogest/ethinyløstradiol til behandling af akne, den potentielle risiko for VTE og sygdommens beskaffenhed, har CHMP konkluderet, at denne kombinationsbehandling kun bør anvendes, når visse andre behandlinger ikke har virket, og kun, hvis kvinden har valgt at bruge p-piller.
English: On 26 January 2016, the European Medicines Agency (EMA) recommended that medicines containing a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be used to treat moderate acne when suitable treatments applied to the skin or antibiotics taken by mouth have not worked.
Danish: Den 26. januar 2016 anbefalede Det Europæiske Lægemiddelagentur (EMA), at kombinationslægemidler, der indeholder dienogest 2 mg og ethinyløstradiol 0,03 mg, fortsat skal kunne bruges til behandling af moderat akne, når relevante midler til anvendelse på huden eller orale antibiotika ikke har virket.
English: Use should be limited to women who choose oral contraception
Danish: Anvendelsen bør begrænses til kvinder, der har valgt at bruge p-piller
English: • Taking into account the available evidence, and in order not to unnecessarily expose women to a potentially higher risk of VTE, use of dienogest/ethinylestradiol should be restricted to second line and to women who also choose oral contraception.
Danish: • Under hensyn til den foreliggende evidens og for ikke at udsætte kvinderne for en unødigt høj risiko for VTE bør anvendelse af dienogest/ethinyløstradiol begrænses til 2. linje-behandling og til kvinder, der også har valgt at bruge p-piller.
English: However, to date, there are insufficient data to accurately determine the relative risk of venous thromboembolism (VTE) with respect to other combined hormonal contraceptives containing other progestogens.
Danish: Hidtil har dataene dog ikke været tilstrækkelige til at foretage en nøjagtig vurdering af den relative risiko for venøs tromboemboli (VTE) i forhold til andre kombinerede hormonelle præventionsmidler, der indeholder andre progestogener.
English: They should only be used when treatments applied to the skin or an antibiotic taken by mouth have not worked.
Danish: Disse kombinationslægemidler bør kun bruges, når midler til anvendelse på huden eller antibiotika i tabletform ikke har virket.
English: Medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg are used as oral contraceptives and for the treatment of moderate acne.
Danish: Lægemidler, der indeholder dienogest 2 mg og ethinyløstradiol 0,03 mg, anvendes som p-piller og til behandling af moderat akne.
English: • You should be aware that, as with other hormonal contraceptives, there is a risk of blood clots associated with the use of dienogest/ethinylestradiol.
Danish: • Som ved andre hormonelle præventionsmidler skal du være opmærksom på, at brug af dienogest/ethinyløstradiol er forbundet med en risiko for blodpropper.
English: • When taking dienogest/ethinylestradiol, you should be alert to the signs and symptoms of blood clots in veins, which may include severe pain or swelling in the legs, sudden unexplained breathlessness, rapid breathing or cough, chest pain, and weakness or numbness of the face, arms or legs.
Danish: Det kan være stærk smerte eller hævelse i benene, pludselig uventet stakåndethed, hurtig vejrtrækning eller hoste, brystsmerter og svaghed eller følelsesløshed i ansigt, arme eller ben.
English: • Medicines containing dienogest and ethinylestradiol should only be used to treat moderate acne in women who also choose oral contraception.
Danish: • Lægemidler, der indeholder dienogest og ethinyløstradiol, bør kun anvendes til behandling af moderat akne hos kvinder, der også har valgt at bruge p-piller.
English: • The combination dienogest/ethinylestradiol should be used for the treatment of moderate acne only after failure of suitable local therapies or oral antibiotic treatment in women who elect to use an oral contraceptive.
Danish: • Kombinationslægemidler med dienogest/ethinyløstradiol bør kun anvendes til behandling af moderat akne hos kvinder, der også har valgt at bruge p-piller, og kun, når relevante lokale terapier eller orale antibiotika ikke har virket.
English: However, the data on the risk with dienogest/ethinylestradiol are not sufficient to accurately estimate how it compares with other contraceptives and further data are still awaited.
Danish: Der foreligger imidlertid ikke tilstrækkelige data om risikoen ved dienogest/ethinyløstradiol til at foretage en nøjagtig vurdering af risikoen for bivirkninger sammenholdt med andre præventionsmidler.
English: It is available as tablets (20 mg).
Danish: Det fås som tabletter (20 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Conbriza on 17 April 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Conbriza den 17. april 2009.
English: This is a summary of the European public assessment report (EPAR) for Conbriza.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Conbriza.
English: The full EPAR for Conbriza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Conbriza findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The women were treated for two years and received calcium supplements.
Danish: Kvinderne blev behandlet i to år og fik calciumtilskud.
English: Conbriza bazedoxifene
Danish: Conbriza bazedoxifen
English: Patients should also receive calcium and vitamin D supplements if they do not get enough from their diet.
Danish: Patienterne bør også få calcium- og vitamin D-tilskud, hvis de ikke får tilstrækkeligt gennem deres kost.
English: The recommended dose of Conbriza is one tablet once a day.
Danish: Den anbefalede dosis af Conbriza er en tablet én gang dagligt.
English: A risk management plan has been developed to ensure that Conbriza is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Conbrizaanvendes så sikkert som muligt.
English: Other information about Conbriza
Danish: Andre oplysninger om Conbriza
English: The difference was more relevant in the sub-group of women at higher risk of fractures before the study.
Danish: Forskellen var mere relevant i undergruppen af kvinder med forhøjet risiko for brud inden undersøgelsen.
English: All of the women in the study were also given calcium and vitamin D supplements.
Danish: Alle kvinderne i undersøgelsen fik også calcium- og vitamin D-tilskud.
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 Conbriza.
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 Conbriza.
English: After three years, 2% of the patients receiving Conbriza (35 out of 1,724) had new fractures compared with 4% of those receiving placebo (59 out of 1,741).
Danish: Efter tre år havde 2 % af de patienter, der fik Conbriza (35 ud af 1 724), fået nye brud sammenlignet med 4 % af dem, der fik placebo (59 ud af 1 741).
English: What measures are being taken to ensure the safe and effective use of Conbriza?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Conbriza?
English: For more information about treatment with Conbriza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Conbriza, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Conbriza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Conbriza opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Conbriza, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Conbriza, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: After two years, the average bone density remained almost unchanged in women who received Conbriza, but in women who received placebo it was reduced by over 1%.
Danish: Efter to år var den gennemsnitlige knogletæthed næsten uforandret hos kvinder, der fik Conbriza, mens den hos kvinder, der fik placebo, blev reduceret med over 1 %.
English: Conbriza is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.
Danish: Conbriza er kun beregnet til kvinder, der har været gennem overgangsalderen, og må derfor ikke anvendes til kvinder, som kan blive gravide.
English: Conbriza is a medicine that contains the active substance bazedoxifene.
Danish: Conbriza er et lægemiddel, der indeholder det aktive stof bazedoxifen.
English: Bazedoxifene has the same effect as oestrogen in the bone.
Danish: Bazedoxifen har samme effekt som østrogen i knoglerne.
English: The active substance in Conbriza, bazedoxifene, is a selective oestrogen receptor modulator (SERM).
Danish: Det aktive stof i Conbriza, bazedoxifen, er en selektiv østrogen receptor modulator (SERM).
English: Conbriza was also compared with raloxifene and placebo in another main study involving 1,583 postmenopausal women who were considered to be at risk of osteoporosis.
Danish: Conbriza blev også sammenlignet med raloxifen og placebo i en anden hovedundersøgelse, som omfattede 1 583 postmenopausale kvinder, som vurderedes at være i risiko for osteoporose.
English: In both main studies the effects of Conbriza were similar to the effects of raloxifene.
Danish: I begge hovedundersøgelser svarede virkningen af Conbriza til virkningen af raloxifen.
English: It must not be used in women with unexplained bleeding from the womb and women with signs or symptoms of endometrial cancer (a cancer of the lining of the womb).
Danish: Det må ikke anvendes til kvinder med uforklarede blødninger fra livmoderen og kvinder med tegn og symptomer på livmoderkræft.
English: The main measure of effectiveness was the change in bone density (a measure of how strong the bones are) in the spine after two years of treatment.
Danish: Behandlingens virkning blev hovedsageligt bedømt på ændringen i knogletæthed (en målestok for, hvor stærke knoglerne er) i rygsøjlen efter to års behandling.
English: It is used in women who are at risk of fracture (broken bones).
Danish: Det anvendes til kvinder med øget risiko for frakturer (knoglebrud).
English: The most common side effects with Conbriza (seen in more than 1 patient in 10) are hot flushes, muscle spasms and peripheral oedema (swelling, especially of the ankles and feet).
Danish: De hyppigste bivirkninger ved Conbriza (som ses hos flere end 1 ud af 10 patienter) er svimmelhed og perifert ødem (hævelse, især på ankler og fødder).
English: Conbriza must not be used in women who have had venous thromboembolism events (problems due to the formation of blood clots in the veins) including deep vein thrombosis (a blood clot in a deep vein, usually in the leg), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Danish: Conbriza må ikke anvendes til kvinder, der har haft tromboemboliske komplikationer (problemer forårsaget af blodpropper i venerne), herunder dyb venetrombose (en blodprop i en dyb vene, sædvanligvis i benene) og lungeemboli (en blodprop i lungerne) og retinal venetrombose (en blodprop i den bageste del af øjet).
English: The main measure of effectiveness was the number of new spine fractures over three years.
Danish: Virkningen blev hovedsageligt bedømt på antallet af nye brud på rygsøjlen i løbet af en periode på tre år.
English: Bazedoxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Danish: Bazedoxifen virker som en østrogenreceptor “agonist” (et stof, som stimulerer østrogenreceptoren) i visse former for kropsvæv.
English: What is the risk associated with Conbriza?
Danish: Hvilken risiko er der forbundet med Conbriza?
English: For the full list of all side effects reported with Conbriza, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Conbriza fremgår af indlægssedlen.
English: Conbriza was not shown to be effective at reducing the number of fractures outside the spine.
Danish: Conbriza viste sig ikke at være effektivt til at reducere antallet af brud uden for rygsøjlen.
English: Conbriza is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Danish: Conbriza anvendes til behandling af osteoporose (en sygdom, der gør knoglerne skøre) hos kvinder, der har været gennem overgangsalderen.
English: Conbriza has been compared with raloxifene (another medicine used to treat osteoporosis) and placebo (a dummy treatment) in one main study involving about 7,500 women with osteoporosis who had been through the menopause.
Danish: Conbriza er blevet sammenlignet med raloxifen (et andet lægemiddel til behandling af osteoporose) og placebo (en virkningsløs behandling) i en hovedundersøgelse med deltagelse af omkring 7 500 kvinder med osteoporose, som havde været gennem overgangsalderen.
English: Why has Conbriza been approved?
Danish: Hvorfor blev Conbriza godkendt?
English: In the first study, Conbriza was more effective than placebo at reducing the number of new spine fractures.
Danish: I den første undersøgelse var Conbriza mere effektivt end placebo til at mindske antallet af nye brud på rygsøjlen.
English: In the other study, Conbriza was also more effective than placebo at maintaining the bone density of the spine.
Danish: I en anden undersøgelse var Conbriza ligeledes mere effektivt end placebo til at bevare knogletætheden i rygsøjlen.
English: What benefit has Conbriza shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Conbriza?
English: Conbriza has been shown to significantly reduce fractures in the spine but not in the hip.
Danish: Det er påvist, at Conbriza i væsentlig grad begrænser forekomsten af brud på rygsøjlen, men ikke hoftebrud.
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Danish: Osteoporose er mest almindeligt hos kvinder efter overgangsalderen, når mængden af det kvindelige kønshormon østrogen falder, eftersom østrogen er med til at holde knoglerne sunde.
English: How has Conbriza been studied?
Danish: Hvordan blev Conbriza undersøgt?
English: What is Conbriza used for?
Danish: Hvad anvendes Conbriza til?
English: How is Conbriza used?
Danish: Hvordan anvendes Conbriza?
English: What is Conbriza?
Danish: Hvad er Conbriza?
English: How does Conbriza work?
Danish: Hvordan virker Conbriza?
English: This summary was last updated in February 2013.
Danish: Dette sammendrag blev sidst ajourført i februar 2013.
English: This will help protect against the disease.
Danish: Derved opnås bedre beskyttelse mod sygdommen.
English: Protection starts 21 days after vaccination and lasts for 105 days.
Danish: Beskyttelse begynder 21 dage efter vaccination og holder sig i 105 dage.
English: The vaccine is given as a single injection into a muscle, preferably the neck muscle behind the ear.
Danish: Vaccinen gives som en enkelt injektion i en muskel, fortrinsvis halsmusklen bag øret.
English: Damage to the wall of small blood vessels in the brain results in characteristic nervous signs.
Danish: Beskadigelse af væggene i de små blodkar i hjernen bevirker karakteristiske symptomer fra nervesystemet.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Ecoporc Shiga on 10 April 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ecoporc Shiga den 10/04/2013.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in piglets.
Danish: Vaccinens virkning blev først undersøgt hos smågrise i en række laboratorieundersøgelser.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: I tilfælde af utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter injektion af lægemidlet, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum, eller æg eller mælk kan anvendes til menneskeligt konsum.
English: Genetically modified recombinant Stx2e antigen
Danish: Genetisk modificeret rekombinant Stx2e-antigen
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ecoporc Shiga exceed the risks for the approved indications and recommended that Ecoporc Shiga be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Ecoporc Shiga opvejer risiciene til de godkendte anvendelser, og anbefalede udstedelse af markedsføringstilladelse for Ecoporc Shiga.
English: The modified toxin in the vaccine is produced by a method known as ‘recombinant DNA technology': it is made by bacteria which have received a gene (DNA) that makes them produce the modified toxin.
Danish: Det modificerede toksin i vaccinen fremstilles ved "rekombinant DNA-teknologi": Det produceres af en bakterie, der har fået indsat et gen (DNA), som gør den i stand til at producere det modificerede toksin.
English: In the future, if the animals are exposed to the bacteria producing the unmodified toxin, the immune system will be able to make antibodies against it more quickly.
Danish: Hvis dyret efterfølgende udsættes for bakterien, der danner det ikke-modificerede toksin, vil immunsystemet hurtigere kunne producere antistoffer mod det.
English: The field studies showed that the vaccine reduced the mortality and clinical signs of oedema disease compared with placebo: in all three studies no piglets receiving Ecoporc Shiga died, while up to 11% of piglets receiving placebo died.
Danish: Feltundersøgelserne viste, at vaccinen mindsker dødelighed og kliniske tegn på ødemsyge i forhold til placebo: I alle tre undersøgelser var der ingen af de smågrise, der fik Ecoporc Shiga, som døde, hvorimod op til 11 % af de smågrise, der fik placebo, døde.