FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons.
Danish: Det må ikke anvendes, når det ikke kan virke effektivt, f.eks. til patienter, hvis æggestokke eller testikler ikke er funktionsdygtige, eller til kvinder, som af medicinske årsager bør undgå graviditet.
English: The active substance in Bemfola, follitropin alfa, is a copy of the natural hormone FSH.
Danish: Det aktive stof i Bemfola, follitropin alfa, er en kopi af det naturlige hormon FSH.
English: In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10.
Danish: Hos kvinder ses desuden ovariecyster (væskeblærer i æggestokkene) og hovedpine hos mere end én ud af hver 10 patienter.
English: The follitropin alfa in Bemfola, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce human FSH.
Danish: Follitropin alfa i Bemfola fremstilles ligesom for referenceproduktet GONAL-f ved “rekombinant DNA-teknologi”: Det produceres ved dyrkning af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere humant FSH.
English: The study showed that Bemfola was as effective as GONAL-f at stimulating the ovaries during assisted reproductive techniques, as an average of 11 eggs were retrieved with both medicines.
Danish: Undersøgelsen viste, at Bemfola er lige så effektivt som GONAL-f til at stimulere æggestokkene under kunstig befrugtning, da der i gennemsnit blevet udtaget 11 æg ved behandling med hvert af de to lægemidler.
English: Bemfola has been shown to be comparable to the reference medicine, GONAL-f.
Danish: Bemfola er påvist at være sammenligneligt med referencelægemidlet GONAL-f.
English: • women who do not produce eggs and who do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
Danish: • kvinder, som ikke danner æg, og hos hvem behandling med clomifencitrat ikke virker (et andet lægemiddel, der stimulerer æggestokkene til at danne æg)
English: Bemfola is a ‘biosimilar medicine'.
Danish: Bemfola er et “biosimilært” lægemiddel.
English: In the body, FSH controls reproductive function: in women, it stimulates the production of eggs in the ovaries; in men, it stimulates the production of sperm in the testicles.
Danish: I kroppen regulerer FSH forplantningsfunktionen: Hos kvinder stimulerer det ægdannelsen, og hos mænd stimulerer det dannelsen af sædceller i testiklerne.
English: For more information about treatment with Bemfola, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Bemfola, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Bemfola must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Danish: Bemfola må ikke anvendes hos personer, der er overfølsomme (allergiske) over for follitropin alfa, FSH eller andre af indholdsstofferne.
English: Bemfola is a medicine that contains the active substance follitropin alfa.
Danish: Bemfola er et lægemiddel, der indeholder det aktive stof follitropin alfa.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bemfola, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Bemfola er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: Bemfola is given to stimulate the ovaries to produce more than one egg at a time;
Danish: Bemfola gives for at stimulere æggestokkene til at danne flere end ét æg ad gangen
English: In women, Bemfola must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina.
Danish: Bemfola må ikke gives til kvinder, hvis de har en forstørret æggestok eller en cyste, der skyldes andet end polycystisk ovariesyndrom, eller når der forekommer blødning fra vagina af ukendt årsag.
English: • women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH).
Danish: • kvinder med svær mangel på luteiniserende hormon (LH) og follikelstimulerende hormon (FSH).
English: How is Bemfola used?
Danish: Hvordan anvendes Bemfola?
English: For practical information about using Bemfola, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Bemfola, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Bemfola have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Bemfola?
English: Bemfola is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
Danish: Bemfola gives sammen med et lægemiddel indeholdende LH for at stimulere ægmodningen i æggestokkene
English: For the full list of all side effects reported with Bemfola, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Bemfola fremgår af indlægssedlen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Bemfola has been shown to have a comparable quality, safety and effectiveness to GONAL-f.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Bemfola i henhold til EUkravene til biosimilære lægemidler er påvist at være af en kvalitet, sikkerhed og virkningsprofil, der svarer til GONAL-f. CHMP fandt derfor, at fordelene ved Bemfola ligesom ved GONAL-f er større end dets risici.
English: • women who are undergoing assisted reproductive techniques (fertility treatment) such as in vitro fertilisation.
Danish: • kvinder, der er i behandling for barnløshed (fertilitetsbehandling) f.eks. ved hjælp af kunstig befrugtning.
English: How does Bemfola work?
Danish: Hvordan virker Bemfola ?
English: Bemfola is used together with human chorionic gonadotrophin (hCG) therapy to stimulate sperm production.
Danish: Bemfola anvendes sammen med behandling med humant koriongonadotropin (hCG) til at stimulere produktionen af sædceller
English: The reference medicine for Bemfola is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here.
Danish: Nærmere oplysninger om biosimilære lægemidler kan du finde med spørgsmål og svar her.
English: Bemfola is available as a solution for injection in a prefilled pen.
Danish: Bemfola leveres som injektionsvæske, opløsning, i en fyldt pen.
English: The full EPAR for Zyprexa Velotab can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zyprexa Velotab findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The orodispersible tablets are taken by being placed on the tongue, where they disintegrate quickly in the saliva, or by mixing them in water before swallowing.
Danish: Smeltetabletterne tages ved at lægge dem på tungen, hvor de hurtigt opløses, eller ved at opløse dem i vand først.
English: Zyprexa Velotab contains the same active substance as another medicine called Zyprexa that has been authorised in the European Union (EU) since 1996.
Danish: Zyprexa Velotab indeholder det samme aktive stof som et andet lægemiddel med navnet Zyprexa, der været godkendt i Den Europæiske Union (EU) siden 1996.
English: This is a summary of the European public assessment report (EPAR) for Zyprexa Velotab.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zyprexa Velotab.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zyprexa Velotab on 3 February 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zyprexa Velotab den 3.2.2000.
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 Zyprexa Velotab.
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 Zyprexa Velotab.
English: For more information about treatment with Zyprexa Velotab, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zyprexa Velotab, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The recommended starting dose of Zyprexa Velotab depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Danish: Den anbefalede startdosis af Zyprexa Velotab tabletter afhænger af den behandlede sygdom: Der anvendes 10 mg om dagen til skizofreni og forebyggelse af maniske episoder og 15 mg om dagen til behandling af maniske episoder, medmindre det anvendes sammen med andre lægemidler.
English: Zyprexa Velotab olanzapine
Danish: Zyprexa Velotab olanzapin
English: The most common side effects with Zyprexa Velotab (seen in more than 1 patient in 10) are somnolence (sleepiness), weight gain, orthostatic hypotension (sudden drop in blood pressure on standing up) and raised levels of prolactin (a hormone).
Danish: De hyppigste bivirkninger ved Zyprexa Velotab (som ses hos flere end 1 ud af 10 patienter) er søvnighed, vægtforøgelse, ortostatisk hypotension, pludseligt blodtryksfald, når patienten rejser sig og forhøjet prolaktin (et hormon).
English: Because of this, the studies done with Zyprexa were used to support the use of Zyprexa Velotab.
Danish: Derfor har undersøgelserne udført med Zyprexa været anvendt til at støtte brugen af Zyprexa Velotab.
English: Zyprexa Velotab was as effective as the medicines that it was compared with for the treatment of adults with schizophrenia, the treatment of moderate to severe manic episodes in adults, and the prevention of recurrence in adults with bipolar disorder.
Danish: Zyprexa Velotab var lige så effektiv som sammenligningspræparaterne til behandling af skizofreni hos voksne, behandling af moderate til svære maniske episoder hos voksne og forebyggelse af tilbagefald hos voksne med bipolar sygdom.
English: Three studies were also carried to show that, when taken by mouth, the two medicines produce equivalent levels of olanzapine in the blood.
Danish: Der blev desuden gennemført tre undersøgelser for at vise, at der opnås samme indhold af olanzapin i blodet ved brug af de to lægemidler, når de tages som tabletter.
English: Zyprexa Velotab must not be used in people who are hypersensitive (allergic) to olanzapine or any of the other ingredients.
Danish: Zyprexa Velotab må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for olanzapin eller andre af indholdsstofferne.
English: The CHMP decided that Zyprexa Velotab's benefits are greater than its risks and recommended that Zyprexa Velotab be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Zyprexa Velotab opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The active substance in Zyprexa Velotab, olanzapine, is an antipsychotic medicine.
Danish: Det aktive stof Zyprexa Velotab, olanzapin, er et antipsykotisk lægemiddel.
English: Zyprexa Velotab is a medicine that contains the active substance olanzapine.
Danish: Zyprexa Velotab er et lægemiddel, der indeholder det aktive stof olanzapin.
English: Zyprexa Velotab is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Danish: Zyprexa Velotab anvendes ligeledes til at behandle moderate til svære maniske episoder (ekstremt højt humør) hos voksne.
English: Like Zyprexa, Zyprexa Velotab was more effective at improving symptoms than placebo (a dummy treatment).
Danish: Ligesom Zyprexa var Zyprexa Velotab mere effektivt end placebo (uvirksom behandling) til at forbedre symptomerne.
English: Zyprexa Velotab is used to treat adults with schizophrenia.
Danish: Zyprexa Velotab anvendes til behandling af voksne patienter med skizofreni.
English: Zyprexa Velotab is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Danish: Zyprexa Velotab er også effektivt til at fastholde bedringen hos patienter, hos hvem det har virket i begyndelsen.
English: Other information about Zyprexa Velotab
Danish: Andre oplysninger om Zyprexa Velotab:
English: What is the risk associated with Zyprexa Velotab?
Danish: Hvilken risiko er der forbundet med Zyprexa Velotab?
English: For the full list of all side effects reported with Zyprexa Velotab, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zyprexa Velotab fremgår af indlægssedlen.
English: Why has Zyprexa Velotab been approved?
Danish: Hvorfor er Zyprexa Velotab blevet godkendt?
English: It is available as ‘orodispersible' tablets (5, 10, 15 and 20 mg).
Danish: Det fås som tabletter på 5, 10, 15 og 20 mg. Smeltetabletter er tabletter, som opløses i munden.
English: What is Zyprexa Velotab?
Danish: Hvad er Zyprexa Velotab?
English: How is Zyprexa Velotab used?
Danish: Hvordan anvendes Zyprexa Velotab?
English: What is Zyprexa Velotab used for?
Danish: Hvad anvendes Zyprexa Velotab til?
English: How has Zyprexa Velotab been studied?
Danish: Hvordan blev Zyprexa Velotab undersøgt?
English: What benefit has Zyprexa Velotab shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zyprexa Velotab?
English: How does Zyprexa Velotab work?
Danish: Hvordan virker Zyprexa Velotab?
English: However, all other concerns remain.
Danish: Alle de andre betænkeligheder gør sig dog stadig gældende.
English: There was also insufficient evidence of maintenance of the medicine's effects.
Danish: Der var ligeledes utilstrækkelig dokumentation for fastholdelsen af lægemidlets virkninger.
English: The balance of benefits and risks for TYSABRI remains unchanged.
Danish: Risk/benefit-forholdet for TYSABRI forbliver uændret.
English: What is happening for TYSABRI for the treatment of multiple sclerosis?
Danish: Hvad sker der med TYSABRI til behandling af multipel sklerose?
English: The main measure of effectiveness was the proportion of patients whose symptoms improved after 10 weeks.
Danish: Det primære effektmål var andelen af patienter, hvis symptomer var blevet forbedret efter 10 uger.
English: It was to be used alone, or in combination with other medicines for Crohn's disease.
Danish: Det skulle anvendes alene eller kombineret med andre lægemidler mod Crohns sygdom.
English: International non-proprietary name (INN): natalizumab
Danish: Internationalt fællesnavn (INN): natalizumab
English: It was to be used in patients who had an inadequate response to or could not take conventional treatments for the disease, and who have evidence of active inflammation.
Danish: Det skulle anvendes til patienter, som har utilstrækkelig respons på eller ikke kan tåle sygdommens konventionelle behandlingsformer, og som har tegn på aktiv betændelse.
English: The main measure of effectiveness was the proportion of patients maintaining a response over an additional nine months of treatment.
Danish: Det primære effektmål var andelen af patienter, der fastholdt en respons i løbet af yderligere ni måneders behandling.
English: After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed their recommendation for the refusal of the marketing authorisation on 15 November 2007.
Danish: Efter at have overvejet årsagerne til denne anmodning revurderede CHMP den oprindelige udtalelse og bekræftede sin anbefaling af et afslag på markedsføringstilladelse den 15. november 2007.
English: There are no consequences of this opinion on the use of TYSABRI, which also contains natalizumab, in its authorised indication.
Danish: Denne udtalelse har ingen konsekvenser for brugen af TYSABRI, der også indeholder natalizumab, til de godkendte indikationer.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Danish: Et monoklonalt antistof er et antistof (en proteintype), som er blevet udviklet til at genkende og binde sig til en specifik struktur (kaldet et antigen), som findes i visse af kroppens celler.
English: This was expected to prevent them from moving from the bloodstream into the gut wall, reducing the inflammation in the gut and improving the symptoms of Crohn's disease.
Danish: Dette skulle forhindre dem i at bevæge sig fra blodbanen til tarmvæggen og dermed mindske betændelsen i tarmene og forbedre symptomerne på Crohns sygdom.
English: The CHMP also had concerns over the safety of Natalizumab Elan Pharma in patients with Crohn's disease, because of a risk of serious infections, including the brain infection progressive multifocal leucoencephalopathy (PML).
Danish: I CHMP var der også betænkelighed ved Natalizumab Elan Pharmas sikkerhed hos patienter med Crohns sygdom på grund af risikoen for alvorlige infektioner, herunder hjerneinfektionen progressiv multifokal leukoencefalopati (PML).
English: QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for NATALIZUMAB ELAN PHARMA
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE ANBEFALING AF AFSLAG PÅ ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for NATALIZUMAB ELAN PHARMA
English: Natalizumab has been designed to bind to specific types of integrin (α4β1 and α4β7 integrins), proteins found on the surface of most leucocytes (the white cells in the blood that are involved in the inflammation process).
Danish: Natalizumab er udviklet til at binde sig til specifikke integrintyper (α4β1- og α4β7-integriner), som er proteiner, der findes på overfladen af de fleste leukocytter (de hvide blodlegemer, som er medvirkende til betændelsestilstanden).
English: The active substance in Natalizumab Elan Pharma, natalizumab, has been available in the European Union for the treatment of multiple sclerosis since 2006 as TYSABRI.
Danish: Det aktive stof i Natalizumab Elan Pharma, natalizumab, har været tilgængeligt i Den Europæiske Union til behandlingen af multipel sklerose siden 2006 under betegnelsen TYSABRI.
English: The effects of Natalizumab Elan Pharma were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Natalizumab Elan Pharma er først blevet afprøvet i forsøgsmodeller, inden det blev undersøgt hos mennesker.
English: By blocking the α4β7 integrin, natalizumab was expected to prevent the leucocytes from attaching to the surface of cells within the gut.
Danish: Ved at blokere α4β7-integrinet forventedes natalizumab at forhindre leukocytterne i at sætte sig på cellernes overflade i tarmene.
English: In November 2007, following the re-examination, the CHMP removed their concern regarding the effectiveness of the medicine in patients starting treatment.
Danish: Efter revurderingen var CHMP i november 2007 ikke længere betænkelig ved lægemidlets effektivitet hos patienter, der påbegynder en behandling.
English: The effects of Natalizumab Elan Pharma were tested in two main studies involving a total of 905 patients with moderate to severe Crohn's disease.
Danish: Virkningerne af Natalizumab Elan Pharma blev testet i to hovedundersøgelser, der omfattede i alt 905 patienter med moderat til svær Crohns sygdom.
English: In July 2007, the CHMP was concerned that there was insufficient evidence to show the effectiveness of Natalizumab Elan Pharma.
Danish: I juli 2007 var der i CHMP betænkelighed ved, at der var utilstrækkelig dokumentation for Natalizumab Elan Pharmas effektivitet.
English: On 19 July 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Natalizumab Elan Pharma concentrate for solution for infusion, intended for the treatment of Crohn's disease.
Danish: Den 19. juli 2007 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, hvor det anbefalede at give afslag på ansøgningen om markedsføringstilladelse for lægemidlet Natalizumab Elan Pharma, koncentrat til infusionsopløsning, der er beregnet til behandling af Crohns sygdom.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Natalizumab Elan Pharma in the treatment of Crohn's disease did not outweigh its risks.
Danish: Derfor var CHMP på dette tidspunkt af den opfattelse, at fordelene ved Natalizumab Elan Pharma i behandlingen af Crohns sygdom ikke opvejer risiciene.
English: The active substance in Natalizumab Elan Pharma, natalizumab, is a monoclonal antibody.
Danish: Det aktive stof i Natalizumab Elan Pharma, natalizumab, er et monoklonalt antistof.
English: In the study of patients starting treatment with Natalizumab Elan Pharma, the effects of the medicine were modest.
Danish: I undersøgelsen af patienter, der påbegyndte en behandling med Natalizumab Elan Pharma, var lægemidlets virkninger beskedne.
English: The 354 patients who responded to treatment with Natalizumab Elan Pharma then went on to enter the second study, in which the effects of Natalizumab Elan Pharma in maintaining the response to treatment were compared with those of placebo.
Danish: De 354 patienter, der responderede på behandlingen med Natalizumab Elan Pharma, var derefter med i den anden undersøgelse, hvor Natalizumab Elan Pharmas virkninger med hensyn til fastholdelse af responsen på behandlingen blev sammenlignet med virkningerne af placebo.
English: Natalizumab Elan Pharma was expected to be used to treat moderate to severe, active Crohn's disease, a disease causing inflammation of the gut.
Danish: Natalizumab Elan Pharma forventedes anvendt til behandlingen af moderat til svær aktiv Crohns sygdom, som er en sygdom, der giver betændelse i tarmene.
English: Natalizumab Elan Pharma is a concentrated solution that is diluted to make a solution for infusion (drip into a vein).
Danish: Natalizumab Elan Pharma er en koncentreret opløsning, der fortyndes til en infusionsopløsning (intravenøst drop).
English: The first study compared the effects of starting treatment with Natalizumab Elan Pharma with that of placebo (a dummy treatment) in all 905 patients.
Danish: I den første undersøgelse sammenlignede man virkningerne af en påbegyndt behandling med Natalizumab Elan Pharma med virkningerne af placebo (en uvirksom behandling) hos alle 905 patienter.
English: What is Natalizumab Elan Pharma?
Danish: Hvad er Natalizumab Elan Pharma?
English: The company that applied for authorisation is Elan Pharma International Ltd.
Danish: Den virksomhed, der ansøgte om markedsføringstilladelse, er Elan Pharma International Ltd. Ansøgeren anmodede om en revurdering af udtalelsen.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes using Natalizumab Elan Pharma ongoing in the European Union for the treatment of Crohn's disease.
Danish: Virksomheden orienterede CHMP om, at der i Den Europæiske Union ikke er nogen igangværende kliniske undersøgelser med Natalizumab Elan Pharma eller nogen programmer for anvendelse med særlig udleveringstilladelse i forbindelse med behandlingen af Crohns sygdom.