natgillin/translations-raw huggingface dataset:
Den virksomhed, der markedsfører CellCept, skal udlevere oplysningsmateriale til patienter og sundhedspersoner om risikoen for fosterskader og de foranstaltninger og forholdsregler der skal træffes for at undgå graviditet under behandlingen.
The company that markets CellCept will provide educational materials for patients and healthcare professionals explaining the risk of harm to a developing baby and the precautions and measures to be taken to avoid pregnancy during treatment.
Hvilken risiko er der forbundet med CellCept?
What is the risk associated with CellCept?
Af de voksne patienter, der fik en levertransplantation, og som blev behandlet med CellCept, oplevede 38 % afstødning af deres nye lever efter seks måneder sammenlignet med 48 % af dem, der blev behandlet med azathioprin, men andelen af patienter, som oplevede afstødning af deres nye lever efter et år, var den samme i begge grupper, nemlig cirka 4 %.
Following liver transplant, 38% of the adult patients taking CellCept had rejected their new liver after six months, compared with 48% of those taking azathioprine, but the proportion of patients who had lost their new liver after a year was similar in the two groups, at around 4%.
CellCept virker ved at forhindre produktionen af nyt dna og reducerer derigennem hastigheden, hvormed lymfocytterne formerer sig.
By preventing the production of new DNA, CellCept reduces the rate at which the lymphocytes multiply.
Ved transplantation af nyrer er den anbefalede dosis for voksne 1 g to gange dagligt gennem munden (kapsler, tabletter eller oral suspension), og behandlingen skal starte inden for 72 timer efter transplantationen.
For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth (capsules, tablets or oral suspension) starting within 72 hours after the transplant.
Hos børn, der havde fået foretaget en nyretransplantation, svarede afstødningshyppigheden til den, der sås hos voksne patienter, der blev behandlet med CellCept, og den var lavere end den hyppighed, der sås i undersøgelser med børn, som ikke blev behandlet med CellCept.
In children undergoing kidney transplants, the rejection rates were similar to those seen in adults taking CellCept and lower than those seen in other studies of children who did not receive CellCept.
CellCept er et lægemiddel, der indeholder det aktive stof mycophenolatmofetil.
CellCept is a medicine containing the active substance mycophenolate mofetil.
Derudover er virkningen af CellCept som oral suspension blevet undersøgt hos 100 børn, der havde fået foretaget en nyretransplantation.
A further study looked at the effect of CellCept oral suspension in 100 children following a kidney transplant.
I undersøgelsen med hjertetransplanterede patienter oplevede cirka 38 % af de voksne patienter, der blev behandlet med CellCept, og dem, der blev behandlet med azathioprin, organafstødning efter seks måneder.
In the heart transplant study, around 38% of adult patients taking CellCept and those taking azathioprine experienced rejection after six months.
Det aktive stof i CellCept, mycophenolatmofetil, er et immunsupprimerende lægemiddel.
The active substance in CellCept, mycophenolate mofetil, is an immunosuppressive medicine.
Det omdannes i kroppen til mycophenolsyre, der blokerer enzymet inosinmonofosfat-dehydrogenase.
In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
Ved transplantation af lever hos voksne bør CellCept gives som en 1 g-infusion to gange dagligt i de første fire dage efter transplantationen, hvorefter patienten skiftes over til 1,5 g to gange dagligt gennem munden, så snart patienten kan tåle det.
For liver transplants in adults, CellCept should be given as a 1-g infusion twice a day for the first four days after the transplant, before the patient is switched to 1.5 g twice a day by mouth as soon as it can be tolerated.
Ved transplantation af hjerter er den anbefalede dosis til voksne 1,5 g to gange dagligt gennem munden med start fem dage efter transplantationen.
For heart transplants, the recommended adult dose is 1.5 g twice a day by mouth, starting within five days following the transplant.
Hvorfor blev CellCept godkendt?
Why has CellCept been approved?
Den fuldstændige liste over de indberettede bivirkninger ved CellCept fremgår af indlægssedlen.
For the full list of side effects reported with CellCept, see the package leaflet.
Hvad er CellCept?
What is CellCept?
Hvad anvendes CellCept til?
What is CellCept used for?
Oplysninger om begrænsninger i forbindelse med CellCept fremgår af indlægssedlen.
For full details of the restrictions with CellCept, see the package leaflet.
Hvilken fordel viser undersøgelserne, at der er ved CellCept?
What benefit has CellCept shown during the studies?
Hvordan blev CellCept undersøgt?
How has CellCept been studied?
Hvordan anvendes CellCept?
How is CellCept used?
Hvordan virker CellCept?
How does CellCept work?
Lægemiddelform Indgivelsesvej
Strength Pharmaceutical form
EU's procedurenr.
Route of administration
r l g
l t o r
3,8 mikrogram**
3.8 micrograms HA**
AF03-adjuvans bestående af squalen (12,4 mg), sorbitanoleat (1,9 mg), polyoxyethylencetostearylether (2,4 mg) og mannitol (2,3 mg)
AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams)
10 hætteglas (suspension)
10 vials (suspension)
Suspension og emulsion til injektionsvæske, emulsion.
Suspension and emulsion for emulsion for injection
Efter rekonstitution indeholder 1 dosis (0,5 ml): Split influenzavirus, inaktiveret, indeholdende antigen* svarende til: A/California/7/2009 (H1N1)-lignende stamme (X-179A)
Split Influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)
Særnavn Styrke Lægemiddelform Indgivelsesvej
Strength Pharmaceutical Form
10 hætteglas (emulsion)
10 vials (emulsion)
emulsion (adjuvans): hætteglas (glas)
Emulsion (adjuvant): vial (glass)
Intramuskulær anvendelse suspension (H1N1): hætteglas (glas)
Suspension (H1N1): vial (glass);
* opformeret i æg
* propagated in eggs ** haemagglutinin
Dette sammendrag blev sidst ajourført i 04-2014.
This summary was last updated in 04-2014.
Hvis patienterne har behov for mere end 8 inhalationer dagligt, anbefales det, at de taler med lægen om at få deres astmabehandling revurderet.
If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for BiResp Spiromax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for BiResp Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det kan desuden anvendes til behandling af KOL.
It can also be used for the treatment of COPD.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for BiResp Spiromax den 28. april 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for BiResp Spiromax on 28 April 2014.
Det anvendes til behandling af astma hos voksne, når et kombinationsprodukt ikke anses for egnet.
It is used for the treatment of asthma in adults for whom a combination product is considered appropriate.
Det leveres som et inhalationspulver i en bærbar inhalator, og hver inhalation giver en fast dosis af lægemidlet.
It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
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.
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.
Der er udarbejdet en risikostyringsplan for at sikre, at BiResp Spiromax anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that BiResp Spiromax is used as safely as possible.
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.
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.
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.
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.
BiResp Spiromax budesonid/formoterol
BiResp Spiromax budesonide / formoterol
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for BiResp Spiromax.
This is a summary of the European public assessment report (EPAR) for BiResp Spiromax.
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.