natgillin/translations-raw huggingface dataset:
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”. 
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.
Det betyder, at det svarer til et “referencelægemiddel”, der indeholder samme aktive stoffer, men til BiResp Spiromax anvendes en anden inhalator. 
This means that it is similar to a ‘reference medicine' containing the same active substances, but BiResp Spiromax is given using a different inhaler.
KOL er en langvarig sygdom, hvor luftveje og lungeblæresække bliver beskadiget eller blokeret, så vejrtrækningen bliver vanskelig. 
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.
Formoterol er et langtidsvirkende beta-2-stimulerende middel. 
Formoterol is a long-acting beta-2 agonist.
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. 
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.
Til behandling af KOL er den anbefalede dosis 1 eller 2 inhalationer to gange dagligt, afhængigt af den anvendte styrke. 
For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.
Til regelmæssig behandling af astma er den anbefalede dosis 1-4 inhalationer to gange dagligt, afhængigt af den anvendte styrke og astmaens sværhedsgrad. 
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.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for BiResp Spiromax, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge. 
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.
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. 
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.
Til lindring af astma må patienterne kun tage en eller to ekstra inhalationer af BiResp Spiromax 160/4,5 µg for at lindre symptomerne. 
As asthma reliever therapy, patients can take 1 or 2 additional inhalations of BiResp Spiromax 160/4.5 microgram only to relieve their symptoms.
Det virker ved at bindes til beta-2receptorerne i muskelcellerne i luftvejene. 
It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Det virker ligesom naturligt binyrebarkhormon, idet det dæmper immunsystemets aktivitet ved at bindes til receptorer på forskellige typer immunceller. 
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af BiResp Spiromax? 
What measures are being taken to ensure the safe and effective use of BiResp Spiromax?
BiResp Spiromax er et lægemiddel, der indeholder de to aktive stoffer budesonid og formoterol. 
BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol.
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. 
For more information about treatment with BiResp Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
BiResp Spiromax er et “hybridt lægemiddel”. 
BiResp Spiromax is a ‘hybrid medicine'.
Da BiResp Spiromax er et hybridt lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet. 
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.
Hvilke fordele og risici er der forbundet med BiResp Spiromax? 
What are the benefits and risks of BiResp Spiromax?
Når det bindes til receptorerne, får det musklerne til at slappe af, så luftvejene holdes frie, og patienten får lettere ved at trække vejret. 
When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Andre oplysninger om BiResp Spiromax 
Other information about BiResp Spiromax
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. 
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.
Referencelægemidlet for BiResp Spiromax er Symbicort Turbohaler. 
The reference medicine for BiResp Spiromax is Symbicort Turbohaler.
Hvad er BiResp Spiromax, og hvad anvendes det til? 
What is BiResp Spiromax and what is it used for?
Udvalget anbefalede udstedelse af markedsføringstilladelse for BiResp Spiromax. 
The Committee recommended that BiResp Spiromax be given marketing authorisation.
Det er ikke en praktisk vejledning i, hvordan BiResp Spiromax bør anvendes. 
It is not intended to provide practical advice on how to use BiResp Spiromax.
Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Symbicort Turbohaler. 
Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Patientundersøgelserne har været begrænset til at påvise, at BiResp Spiromax er bioækvivalent med referencelægemidlet Symbicort Turbohaler. 
Studies in patients have been limited to tests to determine that BiResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler.
Hvis du ønsker praktisk vejledning om anvendelsen af BiResp Spiromax, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using BiResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Hvorfor er BiResp Spiromax blevet godkendt? 
Why is BiResp Spiromax approved?
Budesonid tilhører gruppen binyrebarkhormoner, der er antiinflammatoriske lægemidler. 
Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids.
Hvordan blev BiResp Spiromax undersøgt? 
How has BiResp Spiromax been studied?
Hvordan anvendes BiResp Spiromax? 
How is BiResp Spiromax used?
4,5 µg formoterol) kan anvendes til regelmæssig behandling af astma og til lindring af symptomerne ved behov. 
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.
Hvordan virker BiResp Spiromax? 
How does BiResp Spiromax work?
London, den 14. december 2006 Ref. dok. 
London, 14 December 2006 Doc.
EMEA/490683/2006 
Ref. EMEA/490683/2006
Firmaet fremlagde resultaterne af to hovedundersøgelser, der omfatter 1 065 patienter. 
The company presented the results of 2 main studies including 1065 patients.
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. 
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Ansøgningen var på dag 113, da firmaet trak den tilbage. 
The application was at day 113 when the company withdrew.
SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for SYNORDIA 
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SYNORDIA
Hvad er Synordia? 
What is Synordia?
Omkring halvdelen af patienterne i denne undersøgelse havde type 2-sukkersyge. 
Around half of the patients in this study had type 2 diabetes.
CHMP er normalt indtil 210 dage om at vurdere en ny ansøgning. 
The CHMP normally takes up to 210 days to evaluate a new application.
Tabletterne indeholder 80 mg fenofibrat og 500 mg metformin, 80 mg fenofibrat og 850 mg metformin eller 54 mg fenofibrat og 850 mg metformin. 
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.
Denne receptor medvirker normalt i kontrollen af koncentrationen af fedtstoffer i kroppen. 
This receptor is normally involved in controlling levels of fat in the body.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Synordia? 
What are the consequences of the withdrawal for patients undergoing clinical trials with Synordia?
Dette håbedes at ville gøre det lettere for patienterne at overholde deres ordination af medicin. 
It was hoped that this would make it easier for patients to stick to their treatment.
Hvad anbefalede CHMP på dette tidspunkt? 
What was the recommendation of the CHMP at that time?
Internationalt fællesnavn (INN): fenofibrat/metforminhydrochlorid 
International non-proprietary name (INN): fenofibrate/metformin hydrochloride
Firmaets brev til EMEA med meddelelsen om tilbagetrækningen kan ses her. 
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Fenofibrat kan medvirke til at korrigere blodets fedtindhold ved i cellerne at aktivere en receptor, der kaldes "peroxisom proliferator-aktiveret receptor (PPAR) alfa". 
Fenofibrate can help to correct blood fat levels by activating a receptor within cells called ‘peroxisome proliferator activated receptor (PPAR) alpha'.
Disse stoffer er i Synordia kombineret i én tablet for at mindske det daglige antal tabletter, patienten skal tage. 
They are combined into one tablet in Synordia in order to reduce the number of tablets the patients need to take every day.
Metformin nedsætter forhøjet blodsukker. 
Metformin reduces elevated blood glucose levels.
Doserne var de samme som de tre doser, der er indeholdt i Synordia tabletter. 
The doses were the same as the 3 doses available in Synordia tablets.
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. 
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.
Hvad forventedes Synordia anvendt til? 
What was Synordia expected to be used for?
Hvilke grunde angav firmaet for tilbagetrækningen af ansøgningen? 
What were the reasons given by the company to withdraw the application?
Når firmaet har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden det afgiver en udtalelse, stille eventuelle supplerende spørgsmål til firmaet på dag 180. 
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.
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. 
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.
Hvordan forventes Synordia at virke? 
How is Synordia expected to work?
CHMP var i færd med at vurdere den dokumentation, som firmaet først havde indleveret, og havde endnu ikke fremsat nogen anbefalinger. 
The CHMP was evaluating the initial documentation provided by the company and had not yet made any recommendations.
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. 
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.
Hvilken dokumentation har firmaet fremlagt i forbindelse med ansøgningen til CHMP? 
What documentation did the company present to support its application to the CHMP?
Ved at aktivere receptoren øger lægemidlet indholdet af HDL-kolesterol og mindsker indholdet af triglycerider og andre fedtstoffer. 
By activating this receptor, the medicine increases levels of HDL cholesterol and decreases levels of triglycerides and other types of fat.
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. 
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.
Behandlingens virkning blev hovedsageligbedømt ved ændringen i blodets triglyceridindhold efter 12 uger. 
The main measure of effectiveness was the change in blood triglyceride levels after 12 weeks.
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. 
The first study included 382 patients with type 2 diabetes and high blood triglyceride levels who were already being treated with metformin.
Firmaet har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser med Synordia. 
The company informed the CHMP that there are no consequences for patients currently included in clinical trials of Synordia.
I begge undersøgelser sammenlignedes virkningen af forskellige doser af fenofibrat og metformin, indtaget hver for sig. 
Both studies compared the effects of various doses of fenofibrate and metformin taken as separate medicines.
Synordia er et lægemiddel, der indeholder de to aktive stoffer fenofibrat og metforminhydrochlorid. 
Synordia is a medicine containing the active substances fenofibrate and metformin hydrochloride.
Efter gennemgang af den indledende dokumentation opstiller CHMP på dag 120 en række spørgsmål, der forelægges firmaet. 
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
CHMP var i færd med at vurdere den dokumentation, som firmaet først havde indleveret. 
The CHMP was evaluating the initial documentation provided by the company.
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. 
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.
Det virker hovedsagelig ved at hæmme kroppens produktion af sukker (glukose) og mindske sukkeroptagelsen fra tarmen. 
It works mainly by inhibiting glucose production and reducing its absorption in the gut.
Tilsammen forventedes de to stoffer at forbedre blodets indhold af fedtstoffer og sukker. 
As a result of the action of both substances, the blood fat and glucose levels were expected to improve.
Ved type 2-sukkersyge producerer bugspytkirtlen ikke nok insulin til at regulere blodsukkeret. 
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.
I undersøgelsen registreredes virk ningen af at supplere patientens medicin med fenofibrat. 
It examined the effect of adding fenofibrate to the patients'
Synordia skulle sammen med kostændringer og motion anvendes til at forbedre indholdet af sukker og fedtstoffer i blodet hos patienter med type 2-sukkersyge. 
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.
Metforminhydrochlorid er et sukkersygemiddel, der har været markedsført siden 1959. 
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.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 14. oktober 1997 Dato for seneste fornyelse: 14. oktober 2007 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 1997
Derfor bør du ikke tage SIFROL, hvis du er gravid, medmindre din læge anbefaler dig at gøre det. 
Therefore, do not take SIFROL if you are pregnant unless your doctor tells you to do so.
Anvendelse af Sifrol tabletter bør overvejes i stedet. 
The use of SIFROL tablets should be considered.
Virkningen blev bevaret hos 87 ud af 103 patienter, som skiftede til Sifrol depottabletter. 
Efficacy was maintained in 87 of 103 patients switched to SIFROL prolonged-release tablets.
Tag dine almindelige SIFROL tabletter som normalt dagen før, du skifter. 
Take your SIFROL (immediate release) tablets as normal the day before you switch.
Et vægttab på 30 kg viste en Cmax-stigning på 45%. 
A decreased body weight by 30 kg results in an increase in Cmax of 45%.
Patienter med nyresygdomme Hvis du har en alvorlig nyresygdom, er SIFROL måske ikke den egnede behandling for dig. 
Patients with kidney disease If you have severe kidney disease, SIFROL may not be a suitable treatment for you.
Advarsler og forsigtighedsregler Kontakt lægen, før du tager SIFROL. 
Warnings and precautions Talk to your doctor before taking SIFROL.
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. 
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.
Din læge vil tale med dig, om du skal fortsætte med at tage SIFROL. 
Your doctor will then discuss with you if you should continue to take SIFROL.
Tag ikke SIFROL: - hvis du er allergisk over for pramipexol eller et af de øvrige indholdsstoffer i SIFROL (angivet i punkt 6). 
Do not take SIFROL: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
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%). 
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).
Sifrol bør ikke anvendes under graviditeten, medmindre det er strengt nødvendigt, og hvis fordelene opvejer den potentielle risiko for fostret. 
SIFROL should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Det er ukendt, hvilken virkning SIFROL kan have på det ufødte barn. 
The effect of SIFROL on the unborn child is not known.
I de fase-III-studier, hvor sikkerhed og virkning af Sifrol depottabletter blev undersøgt, blev patienterne instrueret i at tage studiemedicinen uden hensyntagen til fødeindtagelse. 
In the Phase III studies that established safety and efficacy of SIFROL prolonged-release tablets, patients were instructed to take study medication without regard to food intake.
Brugen af Sifrol har ikke været undersøgt hos hæmolysepatienter eller hos patienter med svært nedsat nyrefunktion. 
The use of SIFROL has not been studied in haemodialysis patients, or in patients with severe renal impairment.
SIFROL indeholder: 
What SIFROL contains
Sifrol bør ikke anvendes til børn og unge med Tourettes sygdom på grund af en negativ balance mellem fordele og ulemper ved denne sygdom (se pkt. 
SIFROL should not be used in children or adolescents with Tourette Disorder because of a negative benefit-risk balance for this disorder (see section 5.1).
Hvis du holder op med at tage SIFROL 
If you stop taking SIFROL
SIFROL depottabletter er specialfremstillede tabletter, hvor det aktive stof langsomt frigives efter indtagelse af tabletten. 
SIFROL prolonged-release tablets is a specially designed tablet from which the active ingredient is gradually released, once the tablet has been ingested.
Nogle patienter har rapporteret om rester i afføringen, der kan ligne intakte Sifrol depottabletter. 
Some patients have reported the occurrence of remnants in faeces which may resemble intact SIFROL prolonged-release tablets.
På grund af mangel på humane data må Sifrol ikke anvendes under amning. 
In the absence of human data, SIFROL should not be used during breast-feeding.
Tag SIFROL depottabletter den næste morgen, og tag så ikke flere almindelige SIFROL tabletter. 
Then take your SIFROL prolonged-release tablets next morning and do not take any more SIFROL (immediate release) tablets.
Hvis du har glemt at tage SIFROL 
If you forget to take SIFROL
Ikke kendt: - Efter at du er stoppet med eller har nedsat dosis i din SIFROL-behandling: Depression, apati, angst, træthed, svedtendens eller smerter kan forekomme (kaldet dopaminagonistabstinenssyndrom eller dopamine agonist withdrawal syndrome - DAWS). 
Not known: - After stopping or reducing your SIFROL treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
Det bør overvejes at nedsætte pramipexoldosis i tilfælde, hvor disse lægemidler administreres samtidigt med Sifrol. 
Reduction of the pramipexole dose should be considered when these medicinal products are administered concomitantly with SIFROL.
SIFROL kan tages alene eller i kombination med levodopa (medicin til behandling af Parkinsons sygdom) 
It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
Sifrol depottabletter er én-gang-daglig oral formulering af pramipexol. 
SIFROL prolonged-release tablets are a once-a-day oral formulation of pramipexole.
I fase-III studier hos Parkinsons patienter blev det ikke observeret, at kropsvægt har nogen klinisk relevant påvirkning på den terapeutiske virkning og tolerabiliteten af Sifrol depottabletter. 
However, in Phase III trials in Parkinson's disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of SIFROL prolonged-release tablets was detected.
Fortæl din læge, hvis du oplever symptomer såsom depression, apati, angst, træthed, svedtendens eller smerter, efter at du er stoppet med eller har nedsat dosis i din SIFROL-behandling. 
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your SIFROL treatment.