FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used for the treatment of asthma in adults for whom a combination product is considered appropriate.
Danish: Det anvendes til behandling af astma hos voksne, når et kombinationsprodukt ikke anses for egnet.
English: It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
Danish: Det leveres som et inhalationspulver i en bærbar inhalator, og hver inhalation giver en fast dosis af lægemidlet.
English: The company initially also applied for a lower strength of BiResp Spiromax, however bioequivalence to the reference product was not demonstrated and the application for this strength was withdrawn.
Danish: Virksomheden ansøgte oprindeligt om en lavere styrke af BiResp Spiromax, men der blev ikke påvist bioækvivalens med referenceproduktet, og ansøgningen for denne styrke blev trukket tilbage.
English: A risk management plan has been developed to ensure that BiResp Spiromax is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at BiResp Spiromax anvendes så sikkert som muligt.
English: BiResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Danish: BiResp Spiromax anvendes desuden til lindring af symptomerne på svær kronisk obstruktiv lungesygdom (KOL) hos voksne, når de tidligere har haft anfald med forværring af sygdommen trods regelmæssig behandling.
English: The two active substances in BiResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Danish: De to aktive stoffer i BiResp Spiromax er velkendte og findes i flere lægemidler, der anvendes til behandling af astma og KOL, enten alene eller i kombination med andre lægemidler.
English: BiResp Spiromax budesonide / formoterol
Danish: BiResp Spiromax budesonid/formoterol
English: This is a summary of the European public assessment report (EPAR) for BiResp Spiromax.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for BiResp Spiromax.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Danish: Det kan anvendes hos patienter, hos hvem sygdommen ikke er tilstrækkeligt kontrolleret ved inhalation af andre astmalægemidler af typen binyrebarkhormoner og “korttidsvirkende beta-2-agonister”, eller hos hvem sygdommen er tilstrækkeligt kontrolleret ved inhalation af binyrebarkhormoner og “langtidsvirkende beta-2-agonister”.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but BiResp Spiromax is given using a different inhaler.
Danish: Det betyder, at det svarer til et “referencelægemiddel”, der indeholder samme aktive stoffer, men til BiResp Spiromax anvendes en anden inhalator.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
Danish: KOL er en langvarig sygdom, hvor luftveje og lungeblæresække bliver beskadiget eller blokeret, så vejrtrækningen bliver vanskelig.
English: Formoterol is a long-acting beta-2 agonist.
Danish: Formoterol er et langtidsvirkende beta-2-stimulerende middel.
English: The higher strength, BiResp Spiromax 320/9 microgram (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD.
Danish: Den større styrke BiResp Spiromax 320/9 µg (320 µg budesonid og 9 µg formoterol) kan kun anvendes til regelmæssig behandling af astma og til behandling af KOL.
English: For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.
Danish: Til behandling af KOL er den anbefalede dosis 1 eller 2 inhalationer to gange dagligt, afhængigt af den anvendte styrke.
English: For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma.
Danish: Til regelmæssig behandling af astma er den anbefalede dosis 1-4 inhalationer to gange dagligt, afhængigt af den anvendte styrke og astmaens sværhedsgrad.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BiResp Spiromax, 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 BiResp Spiromax, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Danish: Dette mindsker frigivelsen af stoffer såsom histamin, der deltager i inflammationsprocessen, hvorved luftvejene bedre kan holdes frie, så patienten får lettere ved at trække vejret.
English: As asthma reliever therapy, patients can take 1 or 2 additional inhalations of BiResp Spiromax 160/4.5 microgram only to relieve their symptoms.
Danish: Til lindring af astma må patienterne kun tage en eller to ekstra inhalationer af BiResp Spiromax 160/4,5 µg for at lindre symptomerne.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Danish: Det virker ved at bindes til beta-2receptorerne i muskelcellerne i luftvejene.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Danish: Det virker ligesom naturligt binyrebarkhormon, idet det dæmper immunsystemets aktivitet ved at bindes til receptorer på forskellige typer immunceller.
English: What measures are being taken to ensure the safe and effective use of BiResp Spiromax?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af BiResp Spiromax?
English: BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol.
Danish: BiResp Spiromax er et lægemiddel, der indeholder de to aktive stoffer budesonid og formoterol.
English: For more information about treatment with BiResp Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med BiResp Spiromax, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: BiResp Spiromax is a ‘hybrid medicine'.
Danish: BiResp Spiromax er et “hybridt lægemiddel”.
English: Because BiResp Spiromax is a hybrid 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 BiResp Spiromax er et hybridt lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What are the benefits and risks of BiResp Spiromax?
Danish: Hvilke fordele og risici er der forbundet med BiResp Spiromax?
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Danish: Når det bindes til receptorerne, får det musklerne til at slappe af, så luftvejene holdes frie, og patienten får lettere ved at trække vejret.
English: Other information about BiResp Spiromax
Danish: Andre oplysninger om BiResp Spiromax
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that BiResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at BiResp Spiromax, 160/4,5 µg og 320/9 µg, er påvist at have en kvalitet svarende til Symbicort Turbohaler og at være bioækvivalent med dette.
English: The reference medicine for BiResp Spiromax is Symbicort Turbohaler.
Danish: Referencelægemidlet for BiResp Spiromax er Symbicort Turbohaler.
English: What is BiResp Spiromax and what is it used for?
Danish: Hvad er BiResp Spiromax, og hvad anvendes det til?
English: The Committee recommended that BiResp Spiromax be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for BiResp Spiromax.
English: It is not intended to provide practical advice on how to use BiResp Spiromax.
Danish: Det er ikke en praktisk vejledning i, hvordan BiResp Spiromax bør anvendes.
English: Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Symbicort Turbohaler.
English: Studies in patients have been limited to tests to determine that BiResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler.
Danish: Patientundersøgelserne har været begrænset til at påvise, at BiResp Spiromax er bioækvivalent med referencelægemidlet Symbicort Turbohaler.
English: For practical information about using BiResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af BiResp Spiromax, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is BiResp Spiromax approved?
Danish: Hvorfor er BiResp Spiromax blevet godkendt?
English: Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids.
Danish: Budesonid tilhører gruppen binyrebarkhormoner, der er antiinflammatoriske lægemidler.
English: How has BiResp Spiromax been studied?
Danish: Hvordan blev BiResp Spiromax undersøgt?
English: How is BiResp Spiromax used?
Danish: Hvordan anvendes BiResp Spiromax?
English: 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever.
Danish: 4,5 µg formoterol) kan anvendes til regelmæssig behandling af astma og til lindring af symptomerne ved behov.
English: How does BiResp Spiromax work?
Danish: Hvordan virker BiResp Spiromax?
English: London, 14 December 2006 Doc.
Danish: London, den 14. december 2006 Ref. dok.
English: Ref. EMEA/490683/2006
Danish: EMEA/490683/2006
English: The company presented the results of 2 main studies including 1065 patients.
Danish: Firmaet fremlagde resultaterne af to hovedundersøgelser, der omfatter 1 065 patienter.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig denne behandling.
English: The application was at day 113 when the company withdrew.
Danish: Ansøgningen var på dag 113, da firmaet trak den tilbage.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SYNORDIA
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for SYNORDIA
English: What is Synordia?
Danish: Hvad er Synordia?
English: Around half of the patients in this study had type 2 diabetes.
Danish: Omkring halvdelen af patienterne i denne undersøgelse havde type 2-sukkersyge.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Danish: CHMP er normalt indtil 210 dage om at vurdere en ny ansøgning.
English: The tablets contain 80 mg fenofibrate and 500 mg metformin, 80 mg fenofibrate and 850 mg metformin, or 54 mg fenofibrate and 850 mg metformin.
Danish: Tabletterne indeholder 80 mg fenofibrat og 500 mg metformin, 80 mg fenofibrat og 850 mg metformin eller 54 mg fenofibrat og 850 mg metformin.
English: This receptor is normally involved in controlling levels of fat in the body.
Danish: Denne receptor medvirker normalt i kontrollen af koncentrationen af fedtstoffer i kroppen.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Synordia?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Synordia?
English: It was hoped that this would make it easier for patients to stick to their treatment.
Danish: Dette håbedes at ville gøre det lettere for patienterne at overholde deres ordination af medicin.
English: What was the recommendation of the CHMP at that time?
Danish: Hvad anbefalede CHMP på dette tidspunkt?
English: International non-proprietary name (INN): fenofibrate/metformin hydrochloride
Danish: Internationalt fællesnavn (INN): fenofibrat/metforminhydrochlorid
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Danish: Firmaets brev til EMEA med meddelelsen om tilbagetrækningen kan ses her.
English: Fenofibrate can help to correct blood fat levels by activating a receptor within cells called ‘peroxisome proliferator activated receptor (PPAR) alpha'.
Danish: Fenofibrat kan medvirke til at korrigere blodets fedtindhold ved i cellerne at aktivere en receptor, der kaldes "peroxisom proliferator-aktiveret receptor (PPAR) alfa".
English: They are combined into one tablet in Synordia in order to reduce the number of tablets the patients need to take every day.
Danish: Disse stoffer er i Synordia kombineret i én tablet for at mindske det daglige antal tabletter, patienten skal tage.
English: Metformin reduces elevated blood glucose levels.
Danish: Metformin nedsætter forhøjet blodsukker.
English: The doses were the same as the 3 doses available in Synordia tablets.
Danish: Doserne var de samme som de tre doser, der er indeholdt i Synordia tabletter.
English: On 7 December 2006, Fournier Laboratories Ireland Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Synordia, for the improvement of glycaemic control and dyslipidaemia in patients with type 2 diabetes.
Danish: Den 7. december 2006 underrettede Fournier Laboratories Ireland Ltd. officielt Udvalget for Humanmedicinske Lægemidler (CHMP) om, at firmaet ønskede at trække sin ansøgning om markedsføringstilladelse tilbage for lægemidlet Synordia, indiceret til forbedring af glykæmisk kontrol og dyslipidæmi hos patienter med type 2-sukkersyge.
English: What was Synordia expected to be used for?
Danish: Hvad forventedes Synordia anvendt til?
English: What were the reasons given by the company to withdraw the application?
Danish: Hvilke grunde angav firmaet for tilbagetrækningen af ansøgningen?
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når firmaet har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål til firmaet på dag 180.
English: It was intended for use in patients who require both fenofibrate and metformin, and whose condition had already been stabilised by taking these two medicines separately.
Danish: Det var beregnet til anvendelse hos patienter, der både har brug for fenofibrat og metformin, og hos hvem tilstanden i forvejen var stabiliseret ved indtagelse af hvert af disse lægemidler for sig.
English: How is Synordia expected to work?
Danish: Hvordan forventes Synordia at virke?
English: The CHMP was evaluating the initial documentation provided by the company and had not yet made any recommendations.
Danish: CHMP var i færd med at vurdere den dokumentation, som firmaet først havde indleveret, og havde endnu ikke fremsat nogen anbefalinger.
English: Patients with type 2 diabetes often have dyslipidaemia (abnormal levels of fat in the blood), such as low levels of high-density lipoprotein (HDL or ‘good') cholesterol and high levels of triglycerides.
Danish: Patienter med type 2-sukkersyge har ofte dyslipidæmi (abnormt fedtstofindhold i blodet), således lavt indhold af high-density lipoprotein (HDL eller "godt" kolesterol) og højt indhold af triglycerider.
English: What documentation did the company present to support its application to the CHMP?
Danish: Hvilken dokumentation har firmaet fremlagt i forbindelse med ansøgningen til CHMP?
English: By activating this receptor, the medicine increases levels of HDL cholesterol and decreases levels of triglycerides and other types of fat.
Danish: Ved at aktivere receptoren øger lægemidlet indholdet af HDL-kolesterol og mindsker indholdet af triglycerider og andre fedtstoffer.
English: The second study examined the effects of a combination of the 2 active substances in 683 patients with abnormal levels of glucose or fat in the blood.
Danish: Den anden undersøgelse vedrørte virkningerne af en kombination af de to aktive stoffer hos 683 patienter med abnormt indhold af sukker eller fedtstoffer i blodet.
English: The main measure of effectiveness was the change in blood triglyceride levels after 12 weeks.
Danish: Behandlingens virkning blev hovedsageligbedømt ved ændringen i blodets triglyceridindhold efter 12 uger.
English: The first study included 382 patients with type 2 diabetes and high blood triglyceride levels who were already being treated with metformin.
Danish: Den første undersøgelse omfattede 382 patienter, der havde type 2-sukkersyge og højt triglyceridindhold i blodet, og som i forvejen var i behandling med metformin.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials of Synordia.
Danish: Firmaet har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser med Synordia.
English: Both studies compared the effects of various doses of fenofibrate and metformin taken as separate medicines.
Danish: I begge undersøgelser sammenlignedes virkningen af forskellige doser af fenofibrat og metformin, indtaget hver for sig.
English: Synordia is a medicine containing the active substances fenofibrate and metformin hydrochloride.
Danish: Synordia er et lægemiddel, der indeholder de to aktive stoffer fenofibrat og metforminhydrochlorid.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Danish: Efter gennemgang af den indledende dokumentation opstiller CHMP på dag 120 en række spørgsmål, der forelægges firmaet.
English: The CHMP was evaluating the initial documentation provided by the company.
Danish: CHMP var i færd med at vurdere den dokumentation, som firmaet først havde indleveret.
English: The main measure of effectiveness was the proportion of patients whose blood glucose and fat levels had returned to within the normal range after 12 weeks of treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt ved den andel af patienterne, hos hvem blodets indhold af sukker og fedtstoffer igen var inden for normalområdet efter 12 ugers behandling.
English: It works mainly by inhibiting glucose production and reducing its absorption in the gut.
Danish: Det virker hovedsagelig ved at hæmme kroppens produktion af sukker (glukose) og mindske sukkeroptagelsen fra tarmen.
English: As a result of the action of both substances, the blood fat and glucose levels were expected to improve.
Danish: Tilsammen forventedes de to stoffer at forbedre blodets indhold af fedtstoffer og sukker.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood.
Danish: Ved type 2-sukkersyge producerer bugspytkirtlen ikke nok insulin til at regulere blodsukkeret.
English: It examined the effect of adding fenofibrate to the patients'
Danish: I undersøgelsen registreredes virk ningen af at supplere patientens medicin med fenofibrat.
English: Synordia was to be used to improve levels of sugar and fat in the blood of patients with type 2 diabetes, along with changes to diet and exercise.
Danish: Synordia skulle sammen med kostændringer og motion anvendes til at forbedre indholdet af sukker og fedtstoffer i blodet hos patienter med type 2-sukkersyge.
English: The active substances in Synordia, fenofibrate and metformin, are both well-known medicines: fenofibrate is a serum lipid reducing agent that has been available in the European Union since 1975, and metformin hydrochloride is an anti-diabetic medicine that has been available since 1959.
Danish: Metforminhydrochlorid er et sukkersygemiddel, der har været markedsført siden 1959.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 1997
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 14. oktober 1997 Dato for seneste fornyelse: 14. oktober 2007
English: Therefore, do not take SIFROL if you are pregnant unless your doctor tells you to do so.
Danish: Derfor bør du ikke tage SIFROL, hvis du er gravid, medmindre din læge anbefaler dig at gøre det.
English: The use of SIFROL tablets should be considered.
Danish: Anvendelse af Sifrol tabletter bør overvejes i stedet.
English: Efficacy was maintained in 87 of 103 patients switched to SIFROL prolonged-release tablets.
Danish: Virkningen blev bevaret hos 87 ud af 103 patienter, som skiftede til Sifrol depottabletter.
English: Take your SIFROL (immediate release) tablets as normal the day before you switch.
Danish: Tag dine almindelige SIFROL tabletter som normalt dagen før, du skifter.
English: A decreased body weight by 30 kg results in an increase in Cmax of 45%.
Danish: Et vægttab på 30 kg viste en Cmax-stigning på 45%.
English: Patients with kidney disease If you have severe kidney disease, SIFROL may not be a suitable treatment for you.
Danish: Patienter med nyresygdomme Hvis du har en alvorlig nyresygdom, er SIFROL måske ikke den egnede behandling for dig.
English: Warnings and precautions Talk to your doctor before taking SIFROL.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager SIFROL.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager SIFROL.
English: Your doctor will then discuss with you if you should continue to take SIFROL.
Danish: Din læge vil tale med dig, om du skal fortsætte med at tage SIFROL.
English: Do not take SIFROL: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke SIFROL: - hvis du er allergisk over for pramipexol eller et af de øvrige indholdsstoffer i SIFROL (angivet i punkt 6).
English: Nausea and fatigue were more often reported in female patients treated with SIFROL (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Danish: Kvalme og træthed blev oftere rapporteret hos kvindelige patienter behandlet med Sifrol (henholdsvis 20,8% og 10,5%) sammenlignet med mandlige patienter (henholdsvis 6,7% og 7,3%).
English: SIFROL should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Danish: Sifrol bør ikke anvendes under graviditeten, medmindre det er strengt nødvendigt, og hvis fordelene opvejer den potentielle risiko for fostret.
English: The effect of SIFROL on the unborn child is not known.
Danish: Det er ukendt, hvilken virkning SIFROL kan have på det ufødte barn.