natgillin/translations-raw huggingface dataset:
EU/2/03/039/001 3 pipetter EU/2/03/039/002 6 pipetter EU/2/03/039/013 4 pipetter EU/2/03/039/019 21 pipetter EU/2/03/039/020 42 pipetter EU/2/03/039/031 1 pipette EU/2/03/039/032 2 pipetter EU/2/03/039/033 9 pipetter EU/2/03/039/034 12 pipetter
EU/2/03/039/001 3 pipettes EU/2/03/039/002 6 pipettes EU/2/03/039/013 4 pipettes EU/2/03/039/019 21 pipettes EU/2/03/039/020 42 pipettes EU/2/03/039/031 1 pipette EU/2/03/039/032 2 pipettes EU/2/03/039/033 9 pipettes EU/2/03/039/034 12 pipettes
EU/2/03/039/005 3 pipetter EU/2/03/039/006 6 pipetter EU/2/03/039/015 4 pipetter EU/2/03/039/023 21 pipetter EU/2/03/039/024 42 pipetter EU/2/03/039/039 1 pipette EU/2/03/039/040 2 pipetter EU/2/03/039/041 9 pipetter EU/2/03/039/042 12 pipetter
EU/2/03/039/005 3 pipettes EU/2/03/039/006 6 pipettes EU/2/03/039/015 4 pipettes EU/2/03/039/023 21 pipettes EU/2/03/039/024 42 pipettes EU/2/03/039/039 1 pipette EU/2/03/039/040 2 pipettes EU/2/03/039/041 9 pipettes EU/2/03/039/042 12 pipettes
EU/2/03/039/003 3 pipetter EU/2/03/039/004 6 pipetter EU/2/03/039/014 4 pipetter EU/2/03/039/021 21 pipetter EU/2/03/039/022 42 pipetter EU/2/03/039/035 1 pipette EU/2/03/039/036 2 pipetter EU/2/03/039/037 9 pipetter EU/2/03/039/038 12 pipetter
EU/2/03/039/003 3 pipettes EU/2/03/039/004 6 pipettes EU/2/03/039/014 4 pipettes EU/2/03/039/021 21 pipettes EU/2/03/039/022 42 pipettes EU/2/03/039/035 1 pipette EU/2/03/039/036 2 pipettes EU/2/03/039/037 9 pipettes EU/2/03/039/038 12 pipettes
SÆRLIG(E) ADVARSEL/ ADVARSLER
SPECIAL WARNING(S)
Ingen bivirkninger eller uønskede kliniske symptomer blev bemærket efter brug af op til 10 gange anbefalet dosis på voksne hunde.
Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs.
Projensdorfer Str. 324, 24106 Kiel
Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324, 24106 Kiel
Der blev ikke set tegn på bivirkninger eller uønskede kliniske effekter.
Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Provenge.
This is a summary of the European public assessment report (EPAR) for Provenge.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union Den 6. september 2013.
The European Commission granted a marketing authorisation valid throughout the European Union for Provenge on 6 September 2013.
Den fuldstændige EPAR for Provenge findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Provenge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Patienten skal overvåges i mindst en halv time efter infusionen.
The patient should be monitored for at least half an hour after the infusion.
Andre oplysninger om Provenge
Other information about Provenge
Leukaferese og infusion gentages yderligere to gange med ca. to ugers mellemrum.
The leukapheresis and infusion are repeated on two further occasions, each approximately 2 weeks apart.
I en hovedundersøgelse med 512 patienter var den gennemsnitlige totale overlevelse for patienter, der fik Provenge, 25,8 måneder, sammenholdt med 21,7 måneder for patienter, der fik placebo.
In a main study involving 512 patients, the average overall survival for patients treated with Provenge was 25.8 months, compared with 21.7 months for patients given placebo.
Der er udarbejdet en risikostyringsplan for at sikre, at Provenge anvendes så risikofrit som muligt.
A risk management plan has been developed to ensure that Provenge is used as safely as possible.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Provenge er større end risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Provenge's benefits are greater than its risks and recommended that it be approved for use in the EU.
Vedrørende sikkerheden konstaterede CHMP, at Provenge generelt var veltolereret.
Regarding its safety, the CHMP noted that Provenge was generally well tolerated.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Provenge?
What measures are being taken to ensure the safe and effective use of Provenge?
Det indeholder immunceller, der udvindes af patientens blod.
It contains immune cells that are extracted from the patient's blood.
Disse celler blandes derefter uden for patientens krop med et “fusionsprotein”, der optages af cellerne.
These cells are then mixed outside the patient's body with a ‘fusion protein', which is taken up by the cells.
Endvidere skal der udføres undersøgelser for at skaffe yderligere støttende data om virkningen af Provenge.
Further studies will also be carried out to provide additional supportive data on the effectiveness of Provenge.
Det anvendes, når kræftsygdommen er metastatisk (dvs. har bredt sig til andre dele af kroppen), og når medicinsk eller kirurgisk kastration (standsning af produktionen af mandligt kønshormon) ikke har virket eller ikke længere virker, men hvor det endnu ikke anses for hensigtsmæssigt at behandle med kemoterapi (lægemidler, der dræber hurtigvoksende celler såsom kræftceller).
It is used when the cancer is metastatic (has spread to other parts of the body), and when medical or surgical castration (stopping the production of male hormones) has not worked or no longer works but treatment with chemotherapy (medicines that kill fast-growing cells like cancer cells) is not yet considered appropriate.
Ca. en halv time før hver infusion skal patienterne tage paracetamol og et antihistamin for at nedsætte infusionsbetingede reaktioner med Provenge.
Around half an hour before each infusion, the patient should take paracetamol and an antihistamine to reduce infusion-related reactions with Provenge.
Den skal også udlevere kort til patienterne til angivelse af de planlagte datoer for leukaferese og infusion.
It will also supply cards for patients to record the scheduled leukapheresis and infusion dates.
CHMP konkluderede, at forbedringen i total overlevelse med Provenge er vigtig for patienterne.
The CHMP concluded that the improvement in overall survival seen with Provenge is important for patients.
Virksomheden skal derudover oprette et EU-baseret register over patienter, der behandles med Provenge, for at overvåge den totale overlevelse og de indberettede bivirkninger (navnlig slagtilfælde og hjertetilfælde), og skal fremlægge data fra et USA-baseret register.
The company will also set up an EUbased registry of patients treated with Provenge in order to monitor overall survival and side effects reported (particularly stroke and heart attack), and will provide data from a US-based registry.
Hvorfor er Provenge blevet godkendt?
Why is Provenge approved?
Når lægemidlet er fremstillet, gives det som en infusion med en varighed på omkring en time.
Once prepared, the medicine is given as an infusion lasting around 1 hour.
Provenge autologe mononukleære celler fra perifert blod aktiveret med PAP-GM-CSF (sipuleucel-T)
Provenge autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (sipuleucel-T)
De vigtigste risici var akutte infusionsreaktioner, toksiske virkninger knyttet til leukafereseproceduren samt infektioner, men CHMP fandt, at disse virkninger kunne behandles og håndteres tilfredsstillende gennem risikominimeringsforanstaltninger for lægemidlet.
The main risks included acute infusion reactions, toxicities associated with the leukapheresis procedure and infections, but the CHMP considered that these were manageable and adequately addressed by risk minimisation measures for this medicine.
Provenge er et kræftlægemiddel, der fremstilles specielt til hver patient ved hjælp af patientens egne immunceller (celler, der er en del af kroppens naturlige forsvar).
Provenge is a cancer medicine that is prepared specifically for each patient using their own immune cells (cells that form part of the body's natural defences).
Provenge er et lægemiddel til avanceret terapi, som kaldes et “somatisk celleterapiprodukt”.
Provenge is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Hvilke risici er der forbundet med Provenge?
What are the risks associated with Provenge?
Provenge blev påvist at forbedre den totale overlevelse (den gennemsnitlige tid, patienterne levede) for patienter med kastrationsresistent metastatisk prostatakræft, i forhold til placebo (virkningsløs behandling).
Provenge was shown to improve overall survival (the average length of time the patients lived) of patients with castration-resistant metastatic prostate cancer, compared with placebo (a dummy treatment).
Hvad er Provenge, og hvad anvendes det til?
What is Provenge and what is it used for?
Desuden skal den virksomhed, der markedsfører Provenge, udlevere informationsmateriale til læger og patienter om, hvordan lægemidlet skal anvendes, og om leukafereseproceduren.
In addition, the company that markets Provenge will provide educational materials for doctors and patients on how to use the medicine and the leukapheresis procedure.
Når immuncellerne infunderes tilbage i patienter, fremkalder de en immunreaktion mod PAP. Immunsystemet vil derfor angribe og dræbe prostatakræftcellerne, fordi de indeholder PAP.
When the immune cells are infused back into the patient, they stimulate an immune response against PAP, resulting in the immune system attacking and killing prostate cancer cells because they contain PAP.
Alvorlige bivirkninger med Provenge er svære akutte infusionsreaktioner, svære infektioner (katetersepsis og stafylokokbakteriæmi), hjertetilfælde og cerebrovaskulære hændelser (hændelser, der berører blodforsyningen til hjernen).
Serious side effects with Provenge include severe acute infusion reactions, severe infection (catheter sepsis and staphylococcal bacteraemia), heart attack and cerebrovascular events (related to the blood supply to the brain).
Tre dage før infusionen udføres en såkaldt leukaferese, dvs. en proces, hvor der indsamles immunceller fra patientens blod, hvorefter de sendes til det sted, hvor lægemidlet fremstilles.
Three days before the infusion, a procedure called leukapheresis is performed to collect immune cells from the patient's blood, and these are then sent to a manufacturing facility to prepare the medicine.
Hvis du ønsker yderligere oplysninger om behandling med Provenge, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Provenge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Provenge er et lægemiddel til immunterapi, dvs. behandling, der stimulerer immunsystemet til at dræbe kræftcellerne.
Provenge is an immunotherapy, a medicine that stimulates the immune system to kill cancer cells.
De hyppigste bivirkninger med Provenge (som kan forekomme hos op til 1 ud af 10 behandlede) er kulderystelser, træthed, feber, kvalme, artralgi (ledsmerter), hovedpine og opkastning.
The most common side effects with Provenge (which may affect more than 1 in 10 people) include chills, fatigue (tiredness), pyrexia (fever), nausea (feeling sick), arthralgia (joint pain), headache and vomiting.
Denne type prostatakræft kaldes kastrationsresistent metastatisk prostatakræft.
This type of prostate cancer is called castration-resistant matastatic prostate cancer.
Provenge leveres som en flydende dispersion til infusion (med drop) i en vene.
Provenge is available as a liquid dispersion for infusion (drip) into a vein.
Det er ikke en praktisk vejledning i, hvordan Provenge bør anvendes.
It is not intended to provide practical advice on how to use Provenge.
Provenge anvendes til behandling af voksne mænd med prostatakræft (blærehalskirtelkræft), som har få eller ingen symptomer.
Provenge is used to treat adult men with cancer of the prostate (a gland of the male reproductive system) who have few or no symptoms.
Provenge skal gives under opsyn af en læge med erfaring i behandling af prostatakræft og i omgivelser, hvor der forefindes genoplivningsudstyr.
It must be given under the supervision of a doctor experienced in the treatment of prostate cancer and in an environment where resuscitation equipment is available.
I produktresuméet og indlægssedlen for Provenge er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Provenge, including the appropriate precautions to be followed by healthcare professionals and patients.
udleveres kun efter recept.
Provenge can only be obtained with a prescription.
Den fuldstændige liste over indberettede bivirkninger med Provenge fremgår af indlægssedlen.
For the full list of all side effects reported with Provenge, see the package leaflet.
Hvordan anvendes Provenge?
How is Provenge used?
Hvis du ønsker praktisk vejledning om anvendelsen af Provenge, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Provenge, patients should read the package leaflet or contact their doctor or pharmacist.
Hvilke fordele viser undersøgelserne, at der er ved Provenge?
What benefits of Provenge have been shown in studies?
Fusionsproteinet er bundet til granulocyt-makrofagkolonistimulerende faktor (GM-CSF), et molekyle, der aktiverer immunceller.
The fusion protein consists of prostatic acid phosphatase (PAP), a molecule found in most prostate cancer cells, attached to granulocyte-macrophage colony-stimulating factor (GM-CSF), a molecule that activates immune cells.
Hvordan virker Provenge?
How does Provenge work?
Små børn er mest udsat, efterfulgt af unge.
Young children are most at risk, followed by adolescents.
Bexsero fik en markedsføringstilladelse med gyldighed i hele EU den 14. januar 2013.
Bexsero received a marketing authorisation valid throughout the EU on 14 January 2013.
Bexsero bør anvendes i henhold til de officielle anbefalinger.
Bexsero should be used according to official recommendations.
Der blev desuden udført et mindre støttende studie hos voksne, hvor der sås tilsvarende resultater.
A smaller supportive study was also carried out in adults and similar results were seen in this study.
Det antal indsprøjtninger, der gives, og intervallet mellem dem afhænger af patientens alder.
The number of injections given, and the interval between them, varies depending on the age of the patient.
Skønt meningokoksygdom gruppe B er forholdsvis ualmindelig i Europa, er sygdommen mere almindelig i visse regioner i Europa.
Although group B meningococcal disease is relatively uncommon in Europe, it is more common in certain regions of Europe.
Det andet hovedstudie omfattede 1 631 unge mellem 11 og 17 år.
The second main study involved 1,631 adolescents aged between 11 and 17.
Yderligere information om Bexsero findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Bexsero can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om Bexsero
Other information about Bexsero
Det første hovedstudie omfattede 2 627 børn, som var to måneder gamle ved studiets start.
The first main study involved 2,627 children who were two months old when the study started.
Som for alle lægemidler, er data vedrørende brug af Bexsero løbende overvåget.
As for all medicines, data on the use of Bexsero are continuously monitored.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bexsero?
What measures are being taken to ensure the safe and effective use of Bexsero?
Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Bexsero opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Bexsero's benefits are greater than its risks and it can be authorised for use in the EU.
Det vil sige, at proteinerne er bundet til en aluminiumholdig forbindelse for at forstærke immunresponsen.
This means that the proteins are fixed onto a compound containing aluminium, to stimulate a better immune response.
Bivirkninger rapporteret for Bexsero vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Bexsero are carefully evaluated and any necessary action taken to protect patients.
Hvorfor er Bexsero godkendt i EU?
Why is Bexsero authorised in the EU?
Bexsero (meningokok gruppe B-vaccine [rDNA, komponent, adsorberet])
Bexsero (meningococcal group B vaccine [rDNA, component, adsorbed])
En oversigt over Bexsero og hvorfor det er godkendt i EU
An overview of Bexsero and why it is authorised in the EU
Hvis du ønsker yderligere information om anvendelsen af Bexsero, kan du læse indlægssedlen, eller kontakte lægen eller apoteket.
For more information about using Bexsero, see the package leaflet or contact your doctor or pharmacist.
Hvad er Bexsero, og hvad anvendes det til?
What is Bexsero and what is it used for?
Hvilke risici er der forbundet med Bexsero?
What are the risks associated with Bexsero?
Invasiv sygdom opstår, når bakterien spreder sig i kroppen og forårsager alvorlige infektioner såsom meningitis (betændelse i hinderne rundt om hjernen og rygmarven) og septikæmi (blodforgiftning).
Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).
Virkningen af at give en, to eller tre doser af Bexsero (med mindst en måneds mellemrum) blev sammenlignet med at give placebo (virkningsløs behandling).
The effects of giving one, two or three doses of Bexsero (at intervals of at least one month) were compared with giving placebo (a dummy treatment).
Bexsero gives som en dyb injektion i en muskel, helst i skuldermusklen, eller i lårmusklen hos børn på under to år.
It is given by deep injection into a muscle, preferably into the shoulder muscle, or into the thigh muscle in children under two years old.
Virkningerne af tre doser af Bexsero med to måneders mellemrum sammen med andre sædvanlige børnevaccinationer blev sammenlignet med de sædvanlige vaccinationer alene.
The effects of giving three doses of Bexsero at two-month intervals together with other routine infant vaccinations were compared with giving the routine vaccinations alone.
Bexsero er en vaccine, der anvendes til beskyttelse af personer på to måneder og derover mod invasiv meningokoksygdom forårsaget af en gruppe af bakterien Neisseria meningitidis (gruppe B).
Bexsero is a vaccine used to protect individuals from the age of two months against invasive meningococcal disease caused by one group of the bacterium Neisseria meningitidis (group B).
Bexsero fås som injektionsvæske, suspension, i en fyldt sprøjte og udleveres kun på recept.
Bexsero is available as a suspension for injection in a pre-filled syringe and can only be obtained with a prescription.
Hos børn på op til ti år er de hyppigste bivirkninger ved Bexsero (som optræder hos flere end 1 ud af 10 patienter) appetitløshed, søvnighed, grådtendens, hovedpine, diarré, opkastning, udslæt, ledsmerter, feber og irritabilitet foruden ømhed, hævet, hård og rød hud på injektionsstedet.
The most common side effects with Bexsero in children up to 10 years of age (seen in more than 1 patient in 10) are eating disorders, sleepiness, unusual crying, headache, diarrhoea, vomiting, rash, arthralgia (joint pain), fever and irritability as well as tenderness, swelling, hardness and redness of the skin at the injection site.
Studiet blev forlænget for at påvise virkningerne af at give en boosterdosis af Bexsero ved 12-månedersalderen eller senere til børn, som allerede havde fået Bexsero som ganske små, sammenholdt med at give to "indhentningsdoser" til dem, der ikke havde fået Bexsero.
This study was extended to look at the effects of giving a booster dose of Bexsero at or after 12 months of age to children who had already received Bexsero in early infancy, compared with giving two ‘catch-up' doses to those who had not.
Bexsero er påvist at være effektivt til at frembringe en pålidelig immunrespons mod N. meningitidis gruppe B, og risiciene er acceptable.
Bexsero has been shown to produce a robust immune response to N. meningitidis group B and the risks are acceptable.
To hovedstudier viste, at Bexsero var effektivt til at frembringe en immunrespons over for N. meningitidis gruppe B. Studierne målte dannelsen af beskyttende antistoffer, der er i stand til at dræbe bakterierne.
Two main studies showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. The studies measured the production of protective antibodies which are able to kill the bacteria.
Hvordan anvendes Bexsero?
How is Bexsero used?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Bexsero.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bexsero have been included in the summary of product characteristics and the package leaflet.
Undersøgelserne viste, at Bexsero var effektivt til at fremkalde en immunrespons mod N. meningitidis gruppe B. Undersøgelsen hos børn viste desuden, at en enkelt boosterdosis af Bexsero i 12-månedersalderen gav en kraftigere immunrespons hos børn, der allerede havde fået Bexsero, end de to første "indhentningsdoser" hos børn i samme alder, der ikke havde fået Bexsero.
The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B. In addition, a single booster dose of Bexsero at 12 months of age produced a stronger immune response in children who had already received Bexsero than the first of two ‘catchup' doses in children of the same age who had not.
Studiet viste, at Bexsero var effektivt til at frembringe en immunrespons over for N. meningitidis gruppe B, og at der behøvedes to doser for at frembringe tilstrækkelig immunrespons.
The study showed that Bexsero was effective at stimulating an immune response to N. meningitidis group B and that two doses were needed to produce an adequate immune response.
Hos unge er de hyppigste bivirkninger ved Bexsero (som optræder hos flere end 1 ud af 10 patienter) hovedpine, kvalme, utilpashed, muskelsmerter (myalgi) og ledsmerter (artralgi) samt smerte, hævelse, hårdhed og rødme af huden på injektionsstedet.
The most common side effects with Bexsero in adolescents from 11 years of age and adults (seen in more than 1 patient in 10) are headache, nausea (feeling sick) and malaise (feeling unwell), myalgia (muscle pain) and arthralgia as well as pain, swelling, hardness and redness of the skin at the injection site.
Hvilke fordele viser studierne, at der er ved Bexsero?
What benefits of Bexsero have been shown in studies?
Hvordan virker Bexsero?
How does Bexsero work?
Den indeholder dele af bakterien Neisseria meningitidis gruppe B.
Bexsero contains parts of the bacteria N. meningitidis group B.
Den fuldstændige liste over indberettede bivirkninger ved Bexsero fremgår af indlægssedlen.
For the full list of side effects and restrictions with Bexsero, see the package leaflet.
Bexsero indeholder fire proteiner, der findes på overfladen af cellerne af bakterien N. meningitidis gruppe B. Vaccinen er "adsorberet".
Bexsero contains four proteins which are found on the surfaces of cells of the N. meningitidis group B bacterium.
"Essentiel" betyder, at sygdommen ikke har nogen umiddelbar årsag.
‘Essential' means that the disease has no obvious cause.
Denne oversigt blev sidst ajourført i 06-2018.
This summary was last updated in 06-2018.
Xagrid blev oprindeligt godkendt under "særlige omstændigheder".
Xagrid was originally authorised under ‘exceptional circumstances'.