natgillin/translations-raw huggingface dataset:
I den anden undersøgelse, hvor patientrådgivningen også var mere intensiv, var det overordnede vægttab større i løbet af undersøgelsen: 8,1 % med Mysimba, og 4,9 % med placebo.
In the other study, in which patient counselling was also more intensive, the overall weight loss was greater over the study period: 8.1% with Mysimba and 4.9% with placebo.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mysimba?
What measures are being taken to ensure the safe and effective use of Mysimba?
Det vides ikke nøjagtigt, hvordan Mysimba virker, men de to aktive stoffer, naltrexon og bupropion, virker på de dele af hjernen, der styrer fødeindtagelsen og energibalancen, og nedsætter virkningen på de dele af hjernen, der styrer tilfredshedsfølelsen ved fødeindtagelse.
The exact way that Mysimba works is not fully understood, but the two active substances, naltrexone and bupropion, act on the parts of the brain that control food intake and energy balance, as well as reducing the effect of the part of the brain that controls the pleasure associated with eating food.
Hvad er Mysimba, og hvad anvendes det til?
What is Mysimba and what is it used for?
De hyppigste bivirkninger med Mysimba (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme, opkastning og forstoppelse; svimmelhed og mundtørhed var også almindelige (forekommer hos op til 1 ud af hver 10 patienter).
The most common side effects with Mysimba (which may affect more than 1 in 10 people) are nausea and vomiting (feeling and being sick) and constipation; dizziness and dry mouth were also common (seen in up to 1 patient in 10).
Virkningen af behandlingen var mere markant hos patienter, der gennemførte 56 ugers behandling eller havde tabt mindst 5 % af deres oprindelige legemsvægt efter 4 måneder.
The treatment effect was more marked in patients who completed 56 weeks of treatment, or who had lost at least 5% of their original body weight by 4 months.
Under vurderingen blev der gennemgået en igangværende undersøgelse af hjerte-karudfald, men CHMP anbefalede også løbende overvågning af lægemidlets hjertekarvirkninger.
Interim data from an ongoing study of cardiovascular outcomes were reviewed during the assessment although the CHMP also recommended ongoing monitoring of the medicine's cardiovascular effects.
Hvorfor er Mysimba blevet godkendt?
Why is Mysimba approved?
Hvilke risici er der forbundet med Mysimba?
What are the risks associated with Mysimba?
Vedrørende sikkerheden havde CHMP visse betænkeligheder ved de mulige hjerte-karvirkninger (kardiovaskulære udfald) og en let forhøjet risiko for krampeanfald; i hovedsagen kunne de fleste bivirkninger dog håndteres, da patienten kunne holde op med at tage lægemidlet, hvis bivirkningerne var belastende.
Regarding safety, although the CHMP had some concerns about possible effects on the heart and blood vessels (cardiovascular outcomes) and a slightly increased risk of seizures (fits), the most common side effects were largely manageable, as patients could stop taking the medicine if they were bothersome.
Det er ikke en praktisk vejledning i, hvordan Mysimba bør anvendes.
It is not intended to provide practical advice on how to use Mysimba.
Desuden skal den virksomhed, der markedsfører Mysimba, udarbejde en informationspakke til de læger, der udskriver lægemidlet, herunder vejledning om at standse behandlingen ved manglende virkning eller ved betænkelighed ved bivirkningerne.
In addition, the company that markets Mysimba will produce an information pack for doctors prescribing the medicine, including guidance on stopping treatment in patients who do not respond or if there are concerns about side effects.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Mysimba, 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 Mysimba, including the appropriate precautions to be followed by healthcare professionals and patients.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Mysimba opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
On the balance of the available evidence the CHMP decided that Mysimba's benefits are greater than its risks and recommended that it be approved for use in the EU.
Hvis du ønsker yderligere oplysninger om behandling med Mysimba, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Mysimba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Mysimbas evne til at bevirke vægttab er påvist i 4 hovedundersøgelser med deltagelse af ca. 4 500 svært overvægtige eller overvægtige patienter, hvor Mysimba blev sammenlignet med virkningsløs behandling (placebo).
The effects of Mysimba in reducing body weight have been shown in 4 main studies involving around 4,500 obese or overweight patients, in which Mysimba was compared with placebo (a dummy treatment).
Når de to stoffer gives sammen, nedsætter de appetitten og patientens fødeindtagelse og øger samtidig energiforbruget, så patienten lettere kan overholde sin kaloriefattige diæt og tabe sig i vægt.
When given together, their actions reduce appetite and the amount that patients eat, and increase energy expenditure, helping them to stick to a calorie-controlled diet and to reduce their body weight.
Der var bedring med Mysimba i forhold til placebo uanset analysemetoden, men fordelen var mindre med den mest forsigtige beregningsmetode, der forudsatte, at der ikke ville være bedring hos de patienter, der ikke gennemførte undersøgelsen.
The degree of improvement with Mysimba over placebo was similar using different methods of analysis, although the benefits were smallest with the most conservative methods that assumed patients who did not complete the study would not have seen any improvement.
Derefter sættes dosis i løbet af fire uger gradvis op til den anbefalede dosis, dvs. to tabletter to gange dagligt, fortrinsvis sammen med et måltid.
Treatment with Mysimba is started with a single tablet each morning, with the dose gradually increased over 4 weeks to the recommended dose of two tablets twice a day, preferably taken with food.
Den fuldstændige liste over indberettede bivirkninger ved Mysimba fremgår af indlægssedlen.
For the full list of all side effects reported with Mysimba, see the package leaflet.
Virksomheden skal derudover udføre en yderligere undersøgelse af lægemidlets hjerte-karvirkninger.
It will also carry out a further study to assess the effect of the medicine on the heart and blood vessels.
Godt 46 % og 30 % af de patienter, der fik Mysimba, opnåede et vægttab på hhv. 5 og 10 %, sammenholdt med hhv. 34 % og 17 % med placebo.
Some 46% and 30% of patients given Mysimba achieved 5 and 10% weight reductions respectively, compared with 34% and 17% respectively with placebo.
Hvis du ønsker praktisk vejledning om anvendelsen af Mysimba, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Mysimba, patients should read the package leaflet or contact their doctor or pharmacist.
I undersøgelserne registreredes desuden det antal patienter, der opnåede et vægttab på mindst 10 %, og resultaterne blev analyseret med forskellige metoder, der tog hensyn til det antal patienter, der ikke gennemførte undersøgelserne (ca. 50 % i løbet af et år).
The main measures of effectiveness were the percentage reduction in body weight over 28 or 56 weeks of treatment, and the proportion of patients who achieved at least a 5% weight reduction; the studies also looked at the number of patients who achieved at least a more stringent 10% reduction in weight, and the results were analysed using various methods to take account of the number of patients who did not complete the studies (around 50% over one year).
Ca. 13-22 % af de patienter, der fik Mysimba, opnåede et vægttab på mindst 10 %, sammenholdt med 5-6 % af dem, der fik placebo.
About 13 to 22% of those taking Mysimba achieved at least a 10% reduction in weight, while 5 to 6% of placebotreated patients did so.
Hvordan anvendes Mysimba?
How is Mysimba used?
Mysimba må ikke anvendes hos visse patienter med særlig risiko for bivirkninger, herunder patienter med svært nedsat nyre- eller leverfunktion eller ukontrolleret højt blodtryk, patienter, der nogensinde har haft krampeanfald, visse psykiske problemer eller hjernesvulster, eller som er under afvænning fra alkohol eller visse narkotika.
Mysimba must not be used in certain patients at particular risk of side effects, including patients with severely reduced kidney or liver function, those with high blood pressure that is not under control,
Behandlingen bør standses, hvis patienten får visse bivirkninger såsom blodtryksstigning.
Patients should have their response and tolerability to the medicine checked regularly and treatment should be stopped in patients who have certain side effects such as an increase in blood pressure.
Hvilke fordele viser undersøgelserne, at der er ved Mysimba?
What benefits of Mysimba have been shown in studies?
Hvordan virker Mysimba?
How does Mysimba work?
I tre af undersøgelserne var det gennemsnitlige vægttab hos de Mysimba-behandlede ca. 3,7-5,7 %, sammenholdt med 1,3 til 1,9 % for de placebobehandlede.
In three of the studies, the average weight loss in patients treated with Mysimba was around 3.7 to 5.7%, compared with 1.3 to 1.9% with placebo; the proportion of Mysimba-treated patients who achieved 5% weight loss ranged from 28 to 42% compared with 12 to 14% with placebo.
Agenturets udvalg for lægemidler til mennesker (CHMP) fandt, at lægemidlets evne til at bevirke vægttab var begrænset, men tilstrækkelig til at have klinisk betydning.
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that although the effectiveness of the medicine in promoting weight loss was limited, it was sufficient to be clinically significant, and mandatory re-assessment of treatment after 4 months should ensure that the medicine only continues to be used in those in whom the medicine provides adequate benefit.
Den 26. juli 2012
26 July 2012
Det har været godkendt i EU siden april 2004.
It has been authorised in the EU since April 2004.
Den fuldstændige europæiske offentlige vurderingsrapport for Velcade findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full European Public Assessment Report for Velcade can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Det blokerer proteasomet, som er cellernes system til nedbrydning af proteiner, der ikke længere er brug for.
It blocks the proteasome, which is a system within cells that breaks down proteins when they are no longer needed.
Hvis du deltager i en klinisk undersø gelse med Velcade og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Hvad forventedes Velcade anvendt til?
What was Velcade expected to be used for?
CHMP havde forbehold over for de metoder, der var anvendt til at analysere resultaterne, da de efterlod usikkerhed om, hvor stor virkning der var iagttaget.
The CHMP had concerns about the methodology used to analyse the results, which left some uncertainties about the size of the effect seen.
Hvad vil der ske med brugen af Velcade til behandling af myelomatose?
What is happening with Velcade for the treatment of multiple myeloma?
Når kræftcellernes mister evnen til at nedbryde proteiner, f.eks. de proteiner, der kontrollerer cellernes vækst, vil cellerne blive påvirket, så de til sidst dør.
When the proteins in cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and eventually die.
Efter at CHMP havde vurderet virksomhedens besvarelse af den første runde af spørgsmål, var der stadig nogle uafklarede punkter.
After the CHMP had assessed the company's responses to its first round of questions, there were still some unresolved issues.
Udvalget anså denne forskel for næppe at være relevant og var ikke overbevist om, at der var udpeget en undergruppe af patienter, som ville få større gavn af Velcade som tillægsbehandling til rituximab.
The Committee considered that this difference was unlikely to be relevant and was not convinced that a sub-group of patients had been identified who would benefit more from the addition of Velcade to rituximab.
Det gives i kombination med melfalan og prednison (andre lægemidler mod myelomatose) til patienter, der ikke har været behandlet før og ikke er egnede til højdosis-kemoterapi med knoglemarvstransplantation.
It is given in combination with melphalan and prednisone (other medicines for multiple myeloma) to patients who have not been treated before and who are not suitable for high-dose chemotherapy with a bone marrow transplant.
Afgørelsen vil ikke få konsekvenser for anvendelsen af Velcade til de godkendte indikationer.
There are no consequences on the use of Velcade in its authorised indications.
Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, som virksomheden havde indsendt, og stillet en række spørgsmål.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
CHMP betvivlede relevansen af undersøgelsens resultater, der viste, at de patienter, der var blevet behandlet med Velcade plus rituximab, samlet levede uden forværring af sygdommen 1,8 måneder længere end dem, der blev behandlet med rituximab alene (12,8 måneder mod 11 måneder).
The CHMP questioned the relevance of the study results which showed that, overall, patients treated with Velcade plus rituximab lived without their disease getting worse for an average of 1.8 months longer than patients treated with rituximab alone (12.8 months compared with 11 months).
Velcade er et lægemiddel, der indeholder det aktive stof bortezomib.
Velcade is a medicine given by injection that contains the active substance bortezomib.
CHMP var desuden betænkelig ved, at kombinationen af Velcade og rituximab gav flere bivirkninger end rituximab alene.
The CHMP was also concerned that the combination of Velcade and rituximab caused more side effects than rituximab alone.
Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Velcade.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Velcade.
Det anvendes desuden som selvstændig behandling af patienter, hos hvem sygdommen er fremadskridende, og hvor mindst én anden behandling har slået fejl, og som har fået knoglemarvstransplantation eller ikke kan få det.
It is also used on its own in patients whose disease is progressive and who have failed to respond to at least one other treatment and have already had, or cannot undergo, a bone marrow transplant.
I sit officielle brev erklærede virksomheden, at den havde besluttet at trække ansøgningen tilbage, fordi CHMP fandt, at forholdet mellem fordele og risici ikke er positivt efter de forelagte oplysninger.
In its official letter, the company stated that it decided to withdraw the application because the CHMP considered that the data provided did not support a positive benefit-risk balance.
Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede uden forværring af sygdommen.
The main measure of effectiveness was progression free survival (how long the patients lived without their disease getting worse).
Det anvendes til behandling af myelomatose (kræft udgående fra plasmacellerne i knoglemarven).
It is used to treat patients with multiple myeloma (a cancer of the plasma cells in the bone marrow).
På tidspunktet for tilbagetrækningen fandt CHMP derfor, at fordelene ved Velcade til behandling af tilbagefald af follikulært non-Hodgkins lymfom ikke er større end risiciene.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Velcade in the treatment of relapsed follicular non-Hodgkin lymphoma did not outweigh its risks.
Ved tilbagefald af non-Hodgkins follikulært lymfom forventedes Velcade at virke på samme måde som ved de eksisterende anvendelser.
In relapsed follicular non-Hodgkin lymphoma, Velcade was expected to work in the same way as it does in its existing indications.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Velcade eller i programmer for anvendelse af Velcade med særlig udleveringstilladelse?
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Hvordan forventedes Velcade at virke?
How was Velcade expected to work?
officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om ændring af markedsføringstilladelsen for Velcade med henblik på tilføjelse af anvendelse til patienter med tilbagefald af nonHodgkins follikulært lymfom.
On 2 July 2012, Janssen-Cilag International N.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation of Velcade, which would have extended its use to patients with relapsed follicular non-Hodgkin lymphoma.
Ansøgeren forelagde resultaterne af en undersøgelse med 676 patienter med non-Hodgkins follikulært lymfom, hos hvem sygdommen var vendt tilbage eller skredet frem trods forudgående behandling.
The applicant presented the results of a study involving 676 patients with follicular non-Hodgkin lymphoma that had relapsed or progressed despite previous treatments, designed to assess the effects of using Velcade in combination with rituximab compared with using rituximab alone in these patients.
Denne kræftform udgår fra lymfevæv (en del af immunsystemet) og angriber hvide blodlegemer af typen B-lymfocytter eller B-celler.
Velcade was also expected to be used in follicular non-Hodgkin lymphoma (a cancer of the lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes, or B cells), in combination with another medicine called rituximab in patients whose disease had relapsed (returned after treatment).
Dato for første tilladelse: 06/11/2017.
Date of first authorisation: 06/11/2017.
Anafylaktiske reaktioner er rapporteret i meget sjældne tilfælde.
Anaphylactic reactions have been reported in very rare cases.
Efter den anden og efterfølgende injektioner, reduceres denne reaktion markant.
After the second injection, and subsequent administrations, this reaction is markedly reduced.,
1ère avenue 2065 m LID 06516 Carros Frankrig
1ère avenue 2065 m LID 06516 Carros France
PSUR'er for Nobivac LeuFel skal synkroniseres og indsendes med samme hyppighed som for LEUCOGEN.
PSUR submissions for Nobivac LeuFel shall be synchronised and submitted at the same frequency as for LEUCOGEN.
Basisvaccination: - første injektion fra killingerne er 8 uger gamle - anden injektion: 3 til 4 uger senere.
Primary vaccination: - first injection in kittens from eight weeks of age - second injection 3 or 4 weeks later.
Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Adjuvanser: 3% aluminiumhydroxidgel udtrykt som mg Al
Adjuvants: 3% aluminium hydroxide gel expressed as mg Al
ÆSKE MED 10 ELLER 50 HÆTTEGLAS
Box of 10 or 50 vials
Hjælpestoffer : Isotonisk bufferopløsning op til 1 ml
Excipients: Buffered isotonic solution to 1 ml.
Plast- eller kartonæske med 10 hætteglas.
Plastic or cardboard box of 10 vials.
Hætteglas af type I glas indeholdende 1 dosis (1 ml) vaccine, lukket med en 13 mm-diameter butylelastomer prop, fastgjort med en aluminiumskapsel.
Type I glass vials containing one dose (1 ml) of the vaccine closed with a 13 mm-diameter butyl elastomer stopper and aluminium capsule.
Uforligeligheder: Må ikke blandes med andre lægemidler til dyr undtaget FELIGEN CRP eller FELIGEN RCP.
Incompatibilities: Do not mix with any other veterinary medicinal products except FELIGEN RCP or FELIGEN CRP.
Plast- eller kartonæske med 50 hætteglas.
Plastic or cardboard box of 50 vials.
Aktivt stof : Minimumsmængde af renset p45-FeLV-envelope-antigen
Active substance: Minimum quantity of purified p45 FeLV-envelope antigen
HÆTTEGLAS ETIKET
Vial label
Må ikke blandes med lægemidler til dyr undtaget FELIGEN CRP eller FELIGEN RCP.
Do not mix with any other veterinary medicinal products except FELIGEN RCP or FELIGEN CRP.
Der foreligger oplysninger om sikkerhed og virkning, som påviser, at vaccinen kan blandes med og anvendes samtidig med FELIGEN CRP eller FELIGEN RCP.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with FELIGEN CRP or FELIGEN RCP.
Hjælpestoffer: Isotonisk bufferopløsning
Excipients: Buffered isotonic solution to
Dosis svarende til 1 ml indeholder :
Per dose of 1 ml:
Aktivt stof: Minimumsmængde af renset p45-FeLV-envelope-antigen
Active substance: Minimum quantity of purified p45 FeLV-envelope antigen 102 µg
I sjældne tilfælde kan der forekomme let smerte ved palpation, nysen eller konjunktivitis.
Pain at palpation, sneezing or conjunctivitis may be noted in rare cases.
Nobivac LeuFel injektionsvæske, suspension til katte
Nobivac LeuFel suspension for injection for cats
INDLÆGSSEDDEL : Nobivac LeuFel injektionsvæske, suspension til katte.
PACKAGE LEAFLET Nobivac LeuFel suspension for injection for cats
102 mikrog
102 µg FeLV
Indehaver af markedsføringstilladelsen og fremstiller af batchfrigivelse :
Marketing authorisation holder and manufacturer responsible for the batch release
Ved stabil angina forekommer disse symptomer under fysisk anstrengelse.
In stable angina, these symptoms occur during physical effort.
Ved anvendelse mod angina bør behandlingen standses, hvis der ikke er bedring i symptomerne efter tre måneder.
When used for angina, treatment should be stopped if symptoms do not improve after 3 months.
Den fuldstændige EPAR for Ivabradine JensonR findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Ivabradine JensonR can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Hos patienter på over 75 år kan der anvendes en lavere startdosis på 2,5 mg to gange dagligt.
In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Det anvendes i kombination med standardbehandling, som kan omfatte en betablokker.
It is used in combination with standard therapy which can include a beta-blocker.
Lægen bør desuden overveje at standse behandlingen, hvis lægemidlet kun i begrænset omfang er i stand til at mindske symptomerne eller nedsætte hjertefrekvensen.
Also, the doctor should consider stopping treatment if the medicine has only a limited effect on reducing symptoms or reducing the heart rate.
Ivabradine JensonR fås som tabletter (5 og 7,5 mg) og udleveres kun mod recept.
Ivabradine JensonR is available as tablets (5 and 7.5 mg) and can only be obtained with a prescription.
Behandlingen skal standses, hvis hjertefrekvensen vedholdende er lavere end 50 slag i minuttet, eller hvis den langsomme hjertefrekvens (bradykardi) fortsætter.
Treatment must be stopped if the heart rate decreases persistently below 50 beats per minute or if symptoms of bradycardia (slow heart rate) continue.