FrancophonIA/ELRC3.0 huggingface dataset:
English: • In a studies of MabThera given on its own (203 patients), 48% of the patients with follicular lymphoma who had failed previous treatment responded to MabThera.
Danish: • I et studie, hvor MabThera blev givet alene (203 patienter), virkede MabThera hos 48 % af de patienter med follikulært lymfom, som ikke havde responderet på tidligere behandling.
English: In patients whose disease had come back after previous treatment, those receiving MabThera lived for 30.6 months without their disease getting worse, compared with 20.6 months in those receiving chemotherapy alone.
Danish: Hos patienter, hvis sygdom var vendt tilbage efter tidligere behandling, levede de, der blev behandlet med MabThera, i 30,6 måneder, uden at sygdommen blev værre, sammenlignet med 20,6 måneder for de patienter, der kun blev behandlet med kemoterapi.
English: • two inflammatory conditions of blood vessels known as granulomatosis with polyangiitis (GPA or
Danish: • to inflammatoriske tilstande i blodkar kaldet granulomatose med polyangiitis (GPA eller Wegeners granulomatose) og mikroskopisk polyangiitis (MPA)
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of MabThera have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af MabThera.
English: How does MabThera work?
Danish: Hvordan virker MabThera?
English: The study showed that only 5% of patients treated with MabThera had a relapse, compared with 29% of patients treated with azathioprine (another medicine used to treat GPA and MPA).
Danish: 29 % af de patienter, der blev behandlet med azathioprin (et andet lægemiddel til behandling af GPA og MPA).
English: • In a maintenance study in patients whose follicular lymphoma had come back after previous treatment, patients who received MabThera alone lived for an average of 42.2 months without the disease getting worse, compared with 14.3 months in patients who did not receive the medicine.
Danish: • I et vedligeholdelsesstudie hos de patienter, der tidligere var blevet behandlet og hos hvem follikulært lymfom var vendt tilbage, levede patienter, som fik MabThera alene i gennemsnit 42,2 måneder, uden at sygdommen blev værre, sammenlignet med 14,3 måneder for de patienter, der ikke blev behandlet med lægemidlet.
English: • In a study of 817 patients with CLL, patients who had not been treated before lived for an average of 39.8 months without their disease getting worse when they received MabThera in addition to chemotherapy, compared with 32.2 months in patients receiving chemotherapy alone.
Danish: • I et studie hos 817 patienter med CLL levede patienter, der ikke tidligere havde været behandlet, i gennemsnit 39,8 måneder, uden at sygdommen blev værre, når de blev behandlet med MabThera i kombination med kemoterapi, sammenlignet med 32,2 måneder for de patienter, der kun blev behandlet med kemoterapi.
English: • In a study of 399 patients with diffuse large B-cell lymphoma, patients adding MabThera to chemotherapy lived for an average of 35 months without the disease getting worse or the need for a change in treatment, compared with 13 months in those receiving chemotherapy alone.
Danish: • I et studie hos 399 patienter med diffust storcellet B-celle-lymfom levede patienter, der blev behandlet med MabThera i kombination med kemoterapi, i gennemsnit 35 måneder, uden at sygdommen blev værre, eller de fik behov for en anden behandling, sammenlignet med 13 måneder for de patienter, der kun blev behandlet med kemoterapi.
English: • In a follicular lymphoma study involving 322 patients, patients receiving MabThera in addition to chemotherapy lived for an average of 25.9 months without the disease coming back, compared with 6.7 months in those receiving chemotherapy alone.
Danish: • I et studie hos 322 patienter med follikulært lymfom levede patienter, der blev behandlet med MabThera i kombination med kemoterapi, i gennemsnit 25,9 måneder, uden at sygdommen vendte tilbage, sammenlignet med 6,7 måneder for de patienter, der kun blev behandlet med kemoterapi.
English: The Member States' competent authorities will continue to keep the product under regular review.
Danish: Medlemsstaternes kompetente myndigheder vil fortsat føre regelmæssigt tilsyn med produktet.
English: Actira was initially approved in June 1999.
Danish: Actira blev godkendt første gang i juni 1999.
English: London, 14 August 2008 EMEA/CHMP/524135/2008
Danish: London, den 14. august 2008 EMEA/CHMP/524132/2008
English: The final opinion was converted into a Decision by the European Commission on 14 July 2008.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 14. juli
English: The tablets have to be taken orally once daily for up to 10 days, depending on the indication.
Danish: Tabletterne tages oralt én gang dagligt i op til 10 dage afhængig af indikationen.
English: The arbitration procedure was discussed by the CHMP at its plenary meeting in November 2007 and a Rapporteur (Dr Harald Enzmann) and Co-Rapporteur (Dr. Pieter Neels) were appointed.
Danish: Voldgiftsproceduren blev drøftet af CHMP på dets plenarmøde i november 2007, og en rapportør (dr. Harald Enzmann) og medrapportør (dr. Pieter Neels) blev udpeget.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended product information in Annex III.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De faglige konklusioner fremgår af bilag II sammen med den ændrede produktinformation i bilag III.
English: ∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 19 March 2008.
Danish: ∗ Bemærk: Oplysningerne i dette dokument og vedhæftede bilag afspejler kun CHMP's udtalelse dateret den 19. marts 2008.
English: Written explanations were provided by the Marketing Authorisation Holders (MAH) on 18 January 2008 and 27 February 2008.
Danish: Indehaverne af markedsføringstilladelse indsendte skriftlige redegørelser den 18. januar 2008 og 27. februar 2008.
English: In clinical trials the tablets have been studied for up to 14 days treatment.
Danish: Der har været foretaget kliniske undersøgelser af behandling i op til 14 dage med tabletterne.
English: On 19 March 2008, the CHMP recommended the variation to the Marketing Authorisations to include this indication.
Danish: CHMP anbefalede den 19. marts 2008 ændring af markedføringstilladelserne med henblik på at medtage denne indikation.
English: At the end of the mutual recognition procedure there was a discrepancy between different EU Member States regarding the wording of the indication that should adequately reflect the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/2003, as amended, was notified by Belgium to the CHMP on 19 October
Danish: Ved afslutningen af den gensidige anerkendelsesprocedure var der en uoverensstemmelse mellem forskellige EU-medlemsstater om den ordlyd af indikationen, der på passende vis burde afspejle de kliniske data, virksomheden havde indsendt, og Belgien indbragte officielt uoverensstemmelsen til voldgift i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003, som ændret, for CHMP den 19. oktober 2007.
English: Actira film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Danish: Actira, filmovertrukne tabletter, indeholder 400 mg moxifloxacin som hydrochlorid.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Actira and associated names International non-proprietary name (INN): moxifloxacin BACKGROUND INFORMATION *
Danish: UDTALELSE FRA UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 6, STK. 12 Actira og tilknyttede navne Internationalt fællesnavn (INN): moxifloxacin BAGGRUNDSOPLYSNINGER*
English: The Committee further considered that the benefit/risk balance concerning the use of moxifloxacin up to 14 days in the PID indication remains positive, and that information and recommendations on the use of moxifloxacin, and the measures that should be taken before it is prescribed, are adequately addressed in the ‘contraindications' and ‘special warnings and precautions for use' sections of the EU SPC.
Danish: Udvalget vurderede endvidere, at benefit/risk-forholdet ved anvendelse af moxifloxacin i op til 14 dage i PID-indikationen fortsat var positivt, og at oplysninger og anbefalinger for anvendelsen af moxifloxacin samt de forholdsregler, der skal tages inden ordination, er tilstrækkeligt beskrevet i afsnittene vedrørende kontraindikationer samt særlige advarsler og forsigtighedsregler vedrørende brugen i EU-produktresuméet.
English: In terms of safety the longer treatment duration, the risk of effects on cartilage in young patients and the risk of QT-prolongation were of concern.
Danish: Med hensyn til sikkerhed var årsagerne til betænkelighederne den længere behandlingsperiode, risikoen for bruskpåvirkning hos yngre patienter samt risikoen for QT-forlængelse.
English: The Referral procedure was initiated on 15 November with the adoption of a CHMP List of Questions to be addressed by the MAHs.
Danish: Henvisningsproceduren blev indledt den 15. november med vedtagelsen af CHMP's liste med spørgsmål til indehaverne af markedsføringstilladelsen.
English: In view of the data provided on efficacy and safety, the benefit/risk of the proposed extended indication “mild to moderate pelvic inflammatory disease” was therefore considered to be positive by the CHMP as the initially proposed wording was adequately revised to reflect the current knowledge.
Danish: Efter gennemgang af de fremlagte data vedrørende virkning og sikkerhed vurderede CHMP derfor, at benefit/risk-forholdet for den udvidede indikation 'let til moderat underlivsbetændelse' er positivt, eftersom den oprindeligt foreslåede ordlyd var tilstrækkeligt revideret til at afspejle den aktuelle viden.
English: This Referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Danish: Denne henvisningsprocedure vedrører en anmodning om voldgift i forbindelse med en type IIvariation for en nyindikation, således at behandling af let til moderat underlivsbetændelse (PID), dvs. infektioner af de øvre genitalier, herunder salpingitis og endometritis, omfattes af denne.
English: The main unresolved areas of concern identified by Belgium were in terms of efficacy the emergence of moxifloxacin-resistant strains of N. gonorrhoeae and the feasibility of the treatment in the proposed indication in clinical practice.
Danish: De væsentligste områder, som ifølge Belgiens redegørelse ikke var afklarede, var effektivitet, for så vidt angår fremkomsten af moxifloxacin-resistente stammer af N. gonorrhoeae, og muligheden for behandling i klinisk praksis for den indikation, der søgtes godkendt.
English: The CHMP considered that moxifloxacin cannot be used in the setting of PID in empirical monotherapy due to the increasing incidence of fluoroquinolone-resistant N. gonorrhoeae, unless a resistant strain can be excluded.
Danish: CHMP vurderede, at moxifloxacin ikke kan anvendes til PID i empirisk monoterapi på grund af den stigende incidens af fluoroquinolon-resistente N. gonorrhoeae, medmindre man kan udelukke en resistent stamme.
English: Moxifloxacin should therefore be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) for the treatment of mild to moderate PID, unless moxifloxacin-resistant N. gonorrhoeae can be excluded.
Danish: Moxifloxacin bør derfor gives i kombination med et andet passende antibakterielt stof (f.eks. et cephalosporin) til behandling af let til moderat PID, medmindre moxifloxacin-resistent N. gonorrhoeae kan udelukkes.
English: It is approved for the treatment of the following bacterial infections if they are caused by bacteria susceptible to moxifloxacin: acute exacerbation of chronic bronchitis; community acquired pneumonia, except severe cases; acute bacterial sinusitis (adequately diagnosed).
Danish: Det er godkendt til behandling af følgende bakterielle infektioner, hvis de er forårsaget af moxifloxacin-følsomme bakterier: akut eksacerbation af kronisk bronkitis, ikke-hospitalserhvervet lungebetændelse, undtagen i svære tilfælde, akut bakteriel sinusitis (adækvat diagnosticeret).
English: (Invented) name Strength Pharmaceutical Form
Danish: (Særnavn) Navn Styrke
English: Immediate Packaging
Danish: Lægemiddelform Administration Emballage
English: Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the member states
Danish: Bilag I Liste over lægemidlernes navne, farmaceutiske form, styrke, administrationsvej, indehavere af markedsføringstilladelse i medlemsstaterne
English: Giovanni Ogna E Figli S.p.A. Viale Zara 23
Danish: Giovanni Ogna E Figli S.p.A.
English: The full EPAR for Telmisartan Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Telmisartan Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used in patients who have had problems due to blood clots in the past (such as heart disease, a stroke or artery disease) or who have type 2 diabetes that has damaged an organ (such as the eyes, heart or kidneys).
Danish: Det anvendes hos patienter, som tidligere har haft problemer forårsaget af blodpropper (såsom hjertesygdom, et slagtilfælde eller arteriesygdom), eller som har type 2-diabetes, som har forårsaget skade på et organ (såsom øjnene, hjertet eller nyrerne).
English: The doctor should monitor the patient's blood pressure closely when starting Telmisartan Teva, and may decide to adjust the patient's blood pressure-lowering medication.
Danish: Lægen bør nøje overvåge patientens blodtryk, når behandlingen med Telmisartan Teva påbegyndes, og kan beslutte at justere patientens blodtryksnedsættende medicin.
English: The European Commission granted a marketing authorisation valid throughout the EU for Telmisartan Teva on 26 January 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Telmisartan Teva den 26. januar 2010.
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 Telmisartan Teva.
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, hvordan Telmisartan Teva skal anvendes.
English: This is a summary of the European public assessment report (EPAR) for Telmisartan Teva.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Telmisartan Teva.
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Danish: Det gør det også lettere for hjertet at pumpe blod, hvilket kan bidrage til at nedsætte risikoen for hjerte-kar-problemer i fremtiden.
English: For more information about treatment with Telmisartan Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Telmisartan Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The active substance in Telmisartan Teva, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Telmisartan Teva, telmisartan, er en "angiotensin II-receptorantagonist", hvilket betyder, at den blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: For the treatment of essential hypertension, the recommended dose of Telmisartan Teva is 40 mg once a day, but some patients may benefit from using a 20 mg dose.
Danish: Til behandling af essentiel hypertension er den anbefalede dosis af Telmisartan Teva 40 mg en gang dagligt, men visse patienter kan have fordel af en 20 mg-dosis.
English: This means that Telmisartan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Micardis.
Danish: Det betyder, at Telmisartan Teva er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Micardis.
English: Other information about Telmisartan Teva
Danish: Andre oplysninger om Telmisartan Teva
English: The CHMP concluded that, in accordance with EU requirements, Telmisartan Teva has been shown to have comparable quality and to be bioequivalent to Micardis.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Telmisartan Teva er af sammenlignelig kvalitet og er bioækvivalent med Micardis.
English: Telmisartan Teva is a medicine that contains the active substance telmisartan.
Danish: Telmisartan Teva er et lægemiddel, der indeholder det aktive stof telmisartan.
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Danish: Ved at blokere de receptorer, som angiotensin normalt binder sig til, forhindrer telmisartan hormonet i at have nogen virkning, og blodkarrene kan således udvide sig.
English: Telmisartan Teva is used in adults who have essential hypertension (high blood pressure).
Danish: Telmisartan Teva anvendes til voksne med essentiel hypertension (forhøjet blodtryk).
English: For the prevention of cardiovascular problems, the recommended dose is 80 mg once a day.
Danish: Til forebyggelse af hjerte-kar-problemer er den anbefalede dosis 80 mg en gang dagligt.
English: Telmisartan Teva is a ‘generic medicine'.
Danish: Telmisartan Teva er et "generisk lægemiddel".
English: Telmisartan Teva is also used to prevent cardiovascular problems (problems with the heart and blood vessels) such as heart attacks or strokes.
Danish: Telmisartan Teva anvendes også til forebyggelse af hjerte-kar-problemer (problemer med hjertet og blodkarrene), såsom hjertetilfælde og slagtilfælde.
English: Patients with mild or moderately reduced liver function should not receive doses higher than 40 mg a day.
Danish: Patienter med mildt eller moderat nedsat leverfunktion bør ikke få højere dosis end 40 mg dagligt.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.
Danish: Dette medfører, at blodtrykket falder, hvorved de risici, som er forbundet med forhøjet blodtryk, såsom slagtilfælde, reduceres.
English: What are the benefits and risks of Telmisartan Teva?
Danish: Hvilken fordel og risiko er der forbundet med Telmisartan Teva?
English: Therefore, the CHMP's view was that, as for Micardis, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Micardis.
English: reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Danish: Hvis målet for blodtrykket ikke nås, kan dosis øges til 80 mg, eller der kan anvendes andre lægemidler mod forhøjet blodtryk, såsom hydrochlorothiazid, som tillægsbehandling.
English: Because Telmisartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Telmisartan Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Patients with severely reduced kidney function should receive a lower starting dose of 20 mg once a day.
Danish: Patienter med svært nedsat nyrefunktion bør få en lavere startdosis på 20 mg en gang dagligt.
English: Because Telmisartan Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Micardis.
Danish: Da Telmisartan Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Micardis.
English: The Committee recommended that Telmisartan Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Telmisartan Teva.
English: Why has Telmisartan Teva been approved?
Danish: Hvorfor blev Telmisartan Teva godkendt?
English: What is Telmisartan Teva?
Danish: Hvad er Telmisartan Teva?
English: How has Telmisartan Teva been studied?
Danish: Hvordan blev Telmisartan Teva undersøgt?
English: How is Telmisartan Teva used?
Danish: Hvordan anvendes Telmisartan Teva?
English: What is Telmisartan Teva used for?
Danish: Hvad anvendes Telmisartan Teva til?
English: How does Telmisartan Teva work?
Danish: Hvordan virker Telmisartan Teva?
English: After a 28-day course of treatment, the patient stops treatment for 28 days, before starting another 28-day course.
Danish: Efter 28 dages behandling holder patienten pause med behandlingen i 28 dage og begynder derefter på et nyt 28dages behandlingsforløb.
English: Treatment courses may be repeated for as long as the doctor considers the patient to be benefiting from treatment.
Danish: Behandlingen kan gentages, så længe lægen finder, at patienten har gavn af behandlingen.
English: The recommended dose is one ampoule twice a day, ideally 12 hours apart.
Danish: Den anbefalede dosis er én ampul to gange dagligt, helst med 12 timers mellemrum.
English: Further information on Vantobra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vantobra
Danish: Yderligere information om Vantobra findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/vantobra
English: There were no unexpected safety issues with Vantobra.
Danish: Der var ingen uventede sikkerhedsspørgsmål med Vantobra.
English: The Agency noted that safety profile of inhaled tobramycin was well known.
Danish: Agenturet bemærkede, at sikkerhedsprofilen for inhaleret tobramycin var velkendt.
English: As for all medicines, data on the use of Vantobra are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Vantobra løbende overvåget.
English: Vantobra is therefore easier to use and might help patients to stick to their treatment.
Danish: Vantobra er derfor lettere at anvende og kan hjælpe patienterne til bedre at følge deres behandling.
English: Other information about Vantobra
Danish: Andre oplysninger om Vantobra
English: For more information about using Vantobra, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Vantobra, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Vantobra is a ‘hybrid medicine'.
Danish: Vantobra er et "hybridt lægemiddel".
English: Side effects reported with Vantobra are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Vantobra vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: However, the following side effects are seen in up to 1 in 100 patients: dyspnoea (difficulty breathing), dysphonia (hoarseness), pharyngitis (sore throat) and cough.
Danish: Imidlertid ses følgende bivirkninger hos op til 1 ud af 100 patienter: dyspnø (åndenød), dysfoni (hæshed), faryngitis (ondt i halsen) og hoste.