natgillin/translations-raw huggingface dataset:
Hvad anvendes Equilis West Nile til?
What is Equilis West Nile used for?
EMEA/H/C/002609
EMA/CHMP/800908/2012 EMEA/H/C/002609
Det vil sige, at det var hensigten, at skulle svare til et biologisk lægemiddel ("referencelægemidlet"), som allerede er godkendt i Den Europæiske Union (EU).
This means that it was intended to be similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Det var hensigten, at det skulle leveres som injektionsvæske, suspension.
It was to be available as a suspension for injection.
Hvad er Combimarv?
What is Combimarv?
De fundne mangler var af en sådan karakter, at virksomhedens oplysninger ikke kunne anvendes til vurdering af ansøgningen om markedsføringstilladelse.
The failures identified were such that the data provided by the company could not be used to evaluate the marketing authorisation application.
Derudover fremlagde virksomheden resultaterne af en hovedundersøgelse, der omfattede 432 patienter med sukkersyge og sammenlignede sikkerheden og virkningen af de tre lægemidler fra Marvel LifeSciences med de tilsvarende referencelægemidler.
In addition, the company presented the results from a main study in 432 patients with diabetes comparing the safety and effectiveness of the three medicines from Marvel LifeSciences with their respective reference medicines.
I sit officielle brev til agenturet om tilbagetrækningen af ansøgningen meddelte virksomheden, at den havde besluttet at trække ansøgningen tilbage med henblik på at gentage undersøgelserne hos en valideret kontraktforskningsorganisation og indsende supplerende oplysninger.
In its letter notifying the Agency of the withdrawal of application, the company stated that they decided to withdraw the applications in order to repeat the studies at a validated contract research organisation and to submit additional data.
CHMP konstaterede desuden problemer med virksomhedens undersøgelsesresultater, herunder statistiske fejl og manglende oplysninger.
The CHMP also noted problems with the study data provided by the company, including statistical errors and missing information.
Den 13. december 2012 EMA/130437/2013
13 December 2012
Mens CHMP afventede virksomhedens besvarelse af spørgsmålene, anmodede det om en inspektion af det center, hvor undersøgelserne med lægemidlet havde fundet sted.
While the CHMP was awaiting the company's response to the questions, it requested an inspection of the site where studies with the medicine had taken place.
Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål.
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Betænkelighederne vedrørende oplysningerne foranledigede, at CHMP anmodede om en inspektion af Bombay Bioresearch Centre (BBRC) i Indien, hvor der var udført undersøgelser for Marvel LifeSciences (undersøgelsernes sponsor), og af Marvel LifeSciences' afdeling i Det Forenede Kongerige.
The concerns over the data led the CHMP to request an inspection of Bombay Bioresearch Centre (BBRC) in India, where studies were carried out for Marvel LifeSciences (the sponsor of the studies), and also of Marvel LifeSciences's UK site.
Combimarv blev udviklet som et biosimilært lægemiddel.
Combimarv was developed as a biosimilar medicine.
Ansøgningen var en fælles ansøgning fra Marvel LifeSciences for Combimarv og to andre lægemidler (Solumarv og Isomarv medium, der ligeledes er udviklet som biosimilære lægemidler).
The application was a joint application from Marvel LifeSciences for Combimarv and two other medicines (Solumarv and Isomarv medium, also developed as biosimilar medicines).
Efter den indledende vurdering havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Combimarv ikke kunne godkendes.
After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Combimarv could not have been approved.
Virksomheden har til CHMP oplyst, at der på tilbagetrækningstidspunktet ikke var patienter, som blev behandlet med Combimarv i kliniske undersøgelser
The company informed the CHMP that at the time of the withdrawal no patients were receiving Combimarv in clinical trials.
De indledende betænkeligheder vedrørte hovedsagelig fremstillingen af lægemidlet, og hvorvidt Combimarv tilstrækkeligt svarede til referencelægemidlet.
The initial concerns related mainly to the manufacture of the medicine and whether Combimarv was sufficiently similar to its reference medicine.
Den 15. november 2012 meddelte Marvel LifeSciences Ltd officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Combimarv til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret.
On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Combimarv, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Insulinet i Combimarv fremstilles ved "rekombinant DNA-teknologi": Det produceres af en bakterie, der har fået indsat et gen (DNA), som gør den i stand til at producere insulin.
The insulin in Combimarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Der var blandt andet tale om undersøgelser af, hvordan kroppen håndterer Combimarv sammenlignet med Humulin M3, og hvordan disse insuliner påvirker blodsukkeret.
Among these were results from studies that looked at how the body handles Combimarv compared with Humulin M3 and how these insulins affect blood sugar levels.
Hvad forventedes Combimarv anvendt til?
What was Combimarv expected to be used for?
Ved sukkersyge producerer kroppen enten ikke nok insulin til at regulere blodsukkeret, eller også er den ikke i stand til at udnytte insulinet effektivt.
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar or when the body is unable to use insulin effectively.
Virksomheden fremlagde resultaterne af undersøgelser, der skulle vise, at Combimarv svarer til referencelægemidlet Humulin M3 hvad angår struktur, biologisk aktivitet og kliniske virkninger.
The company presented the results of studies designed to show that Combimarv is similar to its reference medicine Humulin M3 in terms of its structure, biological activity and clinical performance.
Combimarv er et lægemiddel, der indeholder det aktive stof insulin, humant.
Combimarv is a medicine that contains the active substance human insulin.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Combimarv?
What consequences does this withdrawal have for patients in clinical trials?
Hvordan forventes Combimarv at virke?
How is Combimarv expected to work?
Combimarv forventedes anvendt til behandling af patienter med sukkersyge, som behøver insulin til regulering af blodsukkeret.
Combimarv was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Det var hensigten, at Combimarv skulle være et erstatningsinsulin, der stærkt ligner det insulin, som kroppen producerer.
Combimarv was intended as a replacement insulin that is similar to the insulin made by the body.
Der blev herunder konstateret en række kritiske og væsentlige forhold, der viste, at udførelsen af undersøgelserne ikke var i overensstemmelse med god klinisk praksis (GCP), og som rejste alvorlig tvivl om pålideligheden af undersøgelsesresultaterne.
The inspection, carried out by the German, Swedish and UK medicines agencies, identified a number of critical and major findings which revealed a failure to conduct the studies in compliance with Good Clinical Practice (GCP) and seriously questioned the reliability of the study data.
Referencelægemidlet for Combimarv i denne ansøgning var Humulin M3.
The reference medicine for Combimarv in this application was Humulin M3. For more information on biosimilar medicines, see the questions-and-answers document here.
London, den 19. november 2009 Dok.
London, 19 November 2009 Doc.
Der manglede ligeledes data om langtidsvirkningerne hos en europæisk population.
There was also a lack of data on the long-term effects in a European population.
Ansøgeren anmodede om en revurdering af udtalelsen.
The applicant requested a re-examination of the opinion.
Det var meningen, at det skulle kunne fås som kapsler.
It was to be available as capsules.
Årsagen til fibromyalgi er ukendt.
The cause of fibromyalgia is not known.
CHMP var af den opfattelse, at lægemidlets virkning var marginal.
The CHMP was of the opinion that the effect of the medicine was marginal.
Neurotransmittere er kemikalier, som sætter nervecellerne i stand til at kommunikere med hinanden.
Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
De primære effektmål var baseret på, hvor stor en forbedring der efter patienternes mening var i symptomerne, navnlig hvad angår smerteniveauerne og deres generelle velbefindende.
The main measures of effectiveness were based on the patients perceived improvement in symptoms, particularly pain levels and their overall wellbeing.
Virksomheden, som ansøgte om tilladelse, er Pierre Fabre Medicament.
The company that applied for authorisation is Pierre Fabre Medicament.
Fibromyalgi kan også give andre symptomer såsom ømhed, stivhed, træthed, angst og ændringer i patientens søvn, følelser og tanker.
Fibromyalgia can also cause other symptoms such as tenderness, stiffness, tiredness, anxiety and changes in how the patient sleeps, feels and thinks.
Efter at have drøftet begrundelserne for denne anmodning revurderede CHMP den oprindelige udtalelse og bekræftede anbefalingen af afslag på ansøgningen om markedsføringstilladelse den 19. november 2009.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 19 November 2009.
Ved at blokere deres genoptagelse forventedes milnacipran at øge kommunikationsniveauet mellem disse nerveceller.
By blocking their re-uptake, milnacipran was expected to increase the level of communication between these nerve cells.
Eftersom disse neurotransmittere er med til at reducere smertefornemmelsen, forventedes det, at en blokering af deres genoptagelse i nervecellerne ville forbedre symptomerne på fibromyalgi.
Since these neurotransmitters are involved in reducing the sensation of pain, it was expected that blocking their re-uptake into nerve cells would improve the symptoms of fibromyalgia.
Det forventedes at virke ved at forhindre neurotransmitterne 5hydroxytryptamin (også kaldet serotonin) og noradrenalin i at blive genoptaget i nervecellerne i hjernen og rygmarven.
It was expected to work by preventing the neurotransmitters 5hydroxytryptamine (also called serotonin) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om markedsføringstilladelse?
What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
CHMP bekræftede anbefalingen af afslag efter at have revurderet den.
The CHMP refusal was confirmed after re-examination.
I tre hovedundersøgelser fik 2 960 voksne patienter med fibromyalgi enten Milnacipran Pierre Fabre Médicament/Impulsor eller placebo (en virkningsløs behandling) i ca. fire til syv måneder.
In three main studies, 2,960 adult patients with fibromyalgia were given either Milnacipran Pierre Fabre Médicament/Impulsor or placebo (a dummy treatment) for around four to seven months.
Milnacipran Pierre Fabre Médicament/Impulsor forventedes anvendt til behandling af voksne med fibromyalgi, som er en sygdom, der giver vedvarende, udbredte smerter og smertereaktioner ved berøring.
Milnacipran Pierre Fabre Médicament/Impulsor was expected to be used to treat adults with fibromyalgia, a disease causing long-lasting, widespread pain and painful responses to touch.
Virkningerne af Milnacipran Pierre Fabre Médicament/Impulsor blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Milnacipran Pierre Fabre Médicament/Impulsor were first tested in experimental models before being studied in humans.
Den 23. juli 2009 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Milnacipran Pierre Fabre Médicament/Impulsor til behandling af fibromyalgi hos voksne.
On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Milnacipran Pierre Fabre Médicament/Impulsor, intended for the treatment of fibromyalgia in adults.
Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om markedsføringstilladelse for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament/Impulsor milnacipran
På daværende tidspunkt var CHMP således af den opfattelse, at fordelene ved Milnacipran Pierre Fabre Médicament/Impulsor til behandling af fibromyalgi ikke opvejer risiciene.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Milnacipran Pierre Fabre Médicament/Impulsor in the treatment of fibromyalgia did not outweigh its risks.
Milnacipran Pierre Fabre Médicament/Impulsor er et lægemiddel, der indeholder det aktive stof milnacipran.
Milnacipran Pierre Fabre Médicament/Impulsor is a medicine that contains the active substance milnacipran.
Virksomheden informerede CHMP om, at der ikke er nogen igangværende kliniske undersøgelser af Milnacipran Pierre Fabre Médicament/Impulsor i Europa anvendt til behandling af fibromyalgi.
The company informed the CHMP that there are currently no ongoing clinical trials with Milnacipran Pierre Fabre Médicament/Impulsor in Europe for fibromyalgia.
Det aktive stof i Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, er en "serotoninnoradrenalin genoptagelseshæmmer".
The active substance in Milnacipran Pierre Fabre Médicament/Impulsor, milnacipran, is a ‘serotoninnoradrenaline re-uptake inhibitor'.
Hvad er Milnacipran Pierre Fabre Médicament/Impulsor?
What is Milnacipran Pierre Fabre Médicament/Impulsor?
Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Milnacipran Pierre Fabre Médicament/Impulsor eller i programmer for anvendelse af Milnacipran Pierre Fabre Médicament/Impulsor med særlig udleveringstilladelse?
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Milnacipran Pierre Fabre Médicament/Impulsor?
Hvad forventedes Milnacipran Pierre Fabre Médicament/Impulsor anvendt til?
What was Milnacipran Pierre Fabre Médicament/Impulsor expected to be used for?
CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Milnacipran Pierre Fabre Médicament/Impulsor.
Hence, the CHMP recommended that Milnacipran Pierre Fabre Médicament/Impulsor be refused marketing authorisation.
Hvordan forventedes Milnacipran Pierre Fabre Médicament/Impulsor at virke?
How was Milnacipran Pierre Fabre Médicament/Impulsor expected to work?
Responsraten i disse patienter var cirka 52%.
The response rate in these patients was about 52%.
Sådanne rapporter har dog været sjældent forekommende.
However, such reports have been infrequent.
Uåbnet flaske: 3 år.
Unopened bottle: 3 years.
Følgende responsrater blev observeret:
The following response rates were observed:
Din læge vil kontrollere dette og tage alle de nødvendige forholdsregler.
Your doctor will monitor this and take any necessary measures.
Voksne og ældre
Adults and older people
• på anmodning fra Det Europæiske Lægemiddelagentur
• At the request of the European Medicines Agency,
Tid i studiet (uger)
Time on study (weeks)
Må ikke sælges enkeltvis.
Not to be sold separately.
Åbnes her
Please open here
Enhver SRE (+TIH)
Any SRE (+TIH)
Patienter i alderen 65 år og derover
Patients aged 65 years and over
De fleste tilfælde har ikke krævet speciel behandling, og symptomerne er forsvundet efter kort tid (nogle timer eller dage).
In most cases no specific treatment is required and the symptoms disappear after a short time (couple of hours or days).
Brug hele indeholdet.
Use the entire contents.
Vær derfor særlig opmærksom når du kører bil, betjener maskiner eller udfører andre opgaver, der kræver din fulde opmærksomhed.
You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Brug ikke Zometa efter den udløbsdato, der står på pakningen.
Do not use Zometa after the expiry date stated on the pack.
Følg nøje alle instruktioner, som du har fået af din læge.
Follow carefully all instructions given to you by your doctor.
De mest almindelige bivirkninger er normalt milde og vil sandsynligvis forsvinde efter kort tid.
The most common ones are usually mild and will probably disappear after a short time.
Mutagenicitet og cancerogent potentiale
Mutagenicity and carcinogenic potential
I nogle tilfælde kan hypokalcæmien være livstruende.
In some instances the hypocalcaemia may be life-threatening.
Zometa bør ikke anvendes under graviditet.
Zometa should not be used during pregnancy.
Børn og unge Zometa bør ikke bruges til børn og teenagere under 18 år.
Children and adolescents Zometa is not recommended for use in adolescents and children below the age of 18 years.
Det bruges til:
It is used:
Hvis du har fået mere Zometa, end du skulle have haft Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge.
If you are given more Zometa than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Mediantid til normo kalcæmi var 4 dage.
Median time to normocalcaemia was 4 days.
Der var ingen statistisk signifikante forskelle mellem de to zoledronsyredoser.
There were no statistically significant differences between the two zoledronic acid doses.
Tidsrummet til forekomst af symptomer varierede fra én dag til flere måneder efter behandlingsstart.
The time to onset of symptoms varied from one day to several months after starting treatment.
Der sås i særdeleshed ikke noget klart bevis for effekt på hyppigheden af fraktur eller på smerte.
In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
Zometa kan gives til patienter i alderen 65 år og derover.
Zometa can be given to people aged 65 years and over.
NA Ikke relevant (Not Applicable)
NA Not Applicable
Reduktion i risiko for gentagne hændelser**
Risk reduction of suffering from multiple events** (%)
• At nedsætte mængden af calcium i blodet hos voksne, hvor det er for højt som følge af tilstedeværelsen af en tumor.
• To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
Opmærksomheden henledes endvidere på muligheden for udvikling af hypomagnesiæmi under behandlingen.
Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Klinisk erfaring med akut overdosis af Zometa er begrænset.
Clinical experience with acute overdose of Zometa is limited.
Andel af patienter med SRE'er (%) p-værdi
Proportion of patients with SREs (%) p-value
Det er på nuværende tidspunkt uklart, om zoledronsyre forårsager uregelmæssig hjerterytme, men du skal sige det til din læge, hvis du oplever sådanne symptomer efter, at du har fået zoledronsyre.
It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.
I løbet af de første 24 timer findes 39±16% af den indgivne dosis i urinen, hvorimod den resterende mængde primært er bundet til knoglevævet.
Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Osteonekrose af andre anatomiske steder
Osteonecrosis of other anatomical sites
Der har været meget sjældne tilfælde af døsighed og søvnighed ved brug af Zometa.
There have been very rare cases of drowsiness and sleepiness with the use of Zometa.
Baseline kreatinin clearance (ml/min)
Baseline creatinine clearance (ml/min)
Mekanismen bag den øgede forekomst af atrieflimren i dette ene kliniske studie er ukendt.
The mechanism behind the increased incidence of atrial fibrillation in this single clinical trial is unknown.
Der er utilstrækkelige data fra anvendelse af zoledronsyre til gravide kvinder.
There are no adequate data on the use of zoledronic acid in pregnant women.
Total legemsclearance er 5,04±2,5 l/h uafhængigt af dosis og uanset køn, alder, race og legemsvægt.
The total body clearance is 5.04 ± 2.5 l/h, independent of dose, and unaffected by gender, age, race, and body weight.
Da der kun eksisterer begrænsede kliniske data for patienter med kraftigt nedsat leverfunktion, kan der ikke gives nogen specifikke anbefalinger for denne patientgruppe.
As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
- Lavt blodtryk.
Low blood pressure.
Behandling af TIH
Treatment of TIH
Al ubrugt opløsning bør kasseres.
Any unused solution should be discarded.
Fortæl lægen, hvis du er gravid eller tror, du er det.
Tell your doctor if you are or think that you may be pregnant.
Alder, vægt, køn og kreatininclearance synes ikke at have nogen effekt på systemisk eksponering af zoledronsyre.
Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Patienterne var lige fordelt mellem den zoledronsyrebehandlede og placebo grupperne.
Patients were evenly distributed between zoledronic acid-treated and placebo groups.
Farmakoterapeutisk klassifikation: Midler til behandling af knoglesygdomme, bisfosfonater, ATCkode: M05BA08
Pharmacotherapeutic group: Drugs for treatment of bone diseases, bisphosphonates, ATC code: M05BA08
Behandlingseffekten var mindre udtalt hos patienter med blastiske læsioner.
The treatment effects were less pronounced in patients with blastic lesions.
* Inkluderer vertebrale og non-vertebrale frakturer ** Indeholder alle skeletrelaterede hændelser, det totale antal samt tid til hver hændelse under undersøgelsen.
* Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not Reached
Patienterne fik enten 4 mg zoledronsyre eller placebo hver fjerde uge i et år.
Patients received either 4 mg zoledronic acid or placebo every four weeks for one year.
Det er ukendt, om zoledronsyre udskilles i human mælk.
It is not known whether zoledronic acid is excreted into human milk.
Selv om der ikke blev observeret teratogenicitet eller føtal toksicitet hos kaniner, blev der observeret maternal toksicitet.
Although no teratogenicity or foetotoxicity was observed in the rabbit, maternal toxicity was found.
Frakturer*
Fractures*
Mange af disse patienter har også modtaget kemoterapi og kortikosteroider og viste tegn på lokal infektion inklusive osteomyelitis.
Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Zometa bør kun genoptages, når serum-kreatinin igen er inden for 10% af baseline.
Zometa should only be resumed when serum creatinine returns to within 10% of baseline.
Hvis opløsningen ikke bruges straks, skal den opbevares i køleskab ved 2 °C - 8 °C.
If the solution is not used immediately, it should be stored in a refrigerator at 2°C - 8°C.
- Lavt niveau af calcium i blodet.
Low level of calcium in the blood.