FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/2/03/039/009 3 pipettes EU/2/03/039/010 6 pipettes EU/2/03/039/017 4 pipettes EU/2/03/039/027 21 pipettes EU/2/03/039/028 42 pipettes EU/2/03/039/047 1 pipette EU/2/03/039/048 2 pipettes EU/2/03/039/049 9 pipettes EU/2/03/039/050 12 pipettes
Danish: EU/2/03/039/009 3 pipetter EU/2/03/039/010 6 pipetter EU/2/03/039/017 4 pipetter EU/2/03/039/027 21 pipetter EU/2/03/039/028 42 pipetter EU/2/03/039/047 1 pipette EU/2/03/039/048 2 pipetter EU/2/03/039/049 9 pipetter EU/2/03/039/050 12 pipetter
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Advocate for extra-large dogs
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Advocate til ekstra store hunde
English: Skin worm
Danish: Loppe larve
English: 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
Danish: 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
English: 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
Danish: 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
English: 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
Danish: 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
English: SPECIAL WARNING(S)
Danish: SÆRLIG(E) ADVARSEL/ ADVARSLER
English: Up to 10 times the recommended dose was tolerated in adult dogs with no evidence of adverse effects or undesirable clinical signs.
Danish: Ingen bivirkninger eller uønskede kliniske symptomer blev bemærket efter brug af op til 10 gange anbefalet dosis på voksne hunde.
English: Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324, 24106 Kiel
Danish: Projensdorfer Str. 324, 24106 Kiel
English: Up to 10 times the recommended dose was tolerated in cats with no evidence of adverse effects or undesirable clinical signs.
Danish: Der blev ikke set tegn på bivirkninger eller uønskede kliniske effekter.
English: This is a summary of the European public assessment report (EPAR) for Provenge.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Provenge.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Provenge on 6 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union Den 6. september 2013.
English: The full EPAR for Provenge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Provenge findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The patient should be monitored for at least half an hour after the infusion.
Danish: Patienten skal overvåges i mindst en halv time efter infusionen.
English: Other information about Provenge
Danish: Andre oplysninger om Provenge
English: The leukapheresis and infusion are repeated on two further occasions, each approximately 2 weeks apart.
Danish: Leukaferese og infusion gentages yderligere to gange med ca. to ugers mellemrum.
English: 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.
Danish: 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.
English: A risk management plan has been developed to ensure that Provenge is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Provenge anvendes så risikofrit som muligt.
English: 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.
Danish: 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.
English: Regarding its safety, the CHMP noted that Provenge was generally well tolerated.
Danish: Vedrørende sikkerheden konstaterede CHMP, at Provenge generelt var veltolereret.
English: What measures are being taken to ensure the safe and effective use of Provenge?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Provenge?
English: It contains immune cells that are extracted from the patient's blood.
Danish: Det indeholder immunceller, der udvindes af patientens blod.
English: These cells are then mixed outside the patient's body with a ‘fusion protein', which is taken up by the cells.
Danish: Disse celler blandes derefter uden for patientens krop med et “fusionsprotein”, der optages af cellerne.
English: Further studies will also be carried out to provide additional supportive data on the effectiveness of Provenge.
Danish: Endvidere skal der udføres undersøgelser for at skaffe yderligere støttende data om virkningen af Provenge.
English: 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.
Danish: 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).
English: Around half an hour before each infusion, the patient should take paracetamol and an antihistamine to reduce infusion-related reactions with Provenge.
Danish: Ca. en halv time før hver infusion skal patienterne tage paracetamol og et antihistamin for at nedsætte infusionsbetingede reaktioner med Provenge.
English: It will also supply cards for patients to record the scheduled leukapheresis and infusion dates.
Danish: Den skal også udlevere kort til patienterne til angivelse af de planlagte datoer for leukaferese og infusion.
English: The CHMP concluded that the improvement in overall survival seen with Provenge is important for patients.
Danish: CHMP konkluderede, at forbedringen i total overlevelse med Provenge er vigtig for patienterne.
English: 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.
Danish: 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.
English: Why is Provenge approved?
Danish: Hvorfor er Provenge blevet godkendt?
English: Once prepared, the medicine is given as an infusion lasting around 1 hour.
Danish: Når lægemidlet er fremstillet, gives det som en infusion med en varighed på omkring en time.
English: Provenge autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (sipuleucel-T)
Danish: Provenge autologe mononukleære celler fra perifert blod aktiveret med PAP-GM-CSF (sipuleucel-T)
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Provenge is a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Danish: Provenge er et lægemiddel til avanceret terapi, som kaldes et “somatisk celleterapiprodukt”.
English: What are the risks associated with Provenge?
Danish: Hvilke risici er der forbundet med Provenge?
English: 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).
Danish: 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).
English: What is Provenge and what is it used for?
Danish: Hvad er Provenge, og hvad anvendes det til?
English: 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.
Danish: Desuden skal den virksomhed, der markedsfører Provenge, udlevere informationsmateriale til læger og patienter om, hvordan lægemidlet skal anvendes, og om leukafereseproceduren.
English: 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.
Danish: Når immuncellerne infunderes tilbage i patienter, fremkalder de en immunreaktion mod PAP. Immunsystemet vil derfor angribe og dræbe prostatakræftcellerne, fordi de indeholder PAP.
English: 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).
Danish: Alvorlige bivirkninger med Provenge er svære akutte infusionsreaktioner, svære infektioner (katetersepsis og stafylokokbakteriæmi), hjertetilfælde og cerebrovaskulære hændelser (hændelser, der berører blodforsyningen til hjernen).
English: 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.
Danish: 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.
English: For more information about treatment with Provenge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: 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.
English: Provenge is an immunotherapy, a medicine that stimulates the immune system to kill cancer cells.
Danish: Provenge er et lægemiddel til immunterapi, dvs. behandling, der stimulerer immunsystemet til at dræbe kræftcellerne.
English: 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.
Danish: 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.
English: This type of prostate cancer is called castration-resistant matastatic prostate cancer.
Danish: Denne type prostatakræft kaldes kastrationsresistent metastatisk prostatakræft.
English: Provenge is available as a liquid dispersion for infusion (drip) into a vein.
Danish: Provenge leveres som en flydende dispersion til infusion (med drop) i en vene.
English: It is not intended to provide practical advice on how to use Provenge.
Danish: Det er ikke en praktisk vejledning i, hvordan Provenge bør anvendes.
English: 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.
Danish: Provenge anvendes til behandling af voksne mænd med prostatakræft (blærehalskirtelkræft), som har få eller ingen symptomer.
English: 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.
Danish: Provenge skal gives under opsyn af en læge med erfaring i behandling af prostatakræft og i omgivelser, hvor der forefindes genoplivningsudstyr.
English: 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.
Danish: I produktresuméet og indlægssedlen for Provenge er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: Provenge can only be obtained with a prescription.
Danish: udleveres kun efter recept.
English: For the full list of all side effects reported with Provenge, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Provenge fremgår af indlægssedlen.
English: How is Provenge used?
Danish: Hvordan anvendes Provenge?
English: For practical information about using Provenge, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Provenge, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Provenge have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Provenge?
English: 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.
Danish: Fusionsproteinet er bundet til granulocyt-makrofagkolonistimulerende faktor (GM-CSF), et molekyle, der aktiverer immunceller.
English: How does Provenge work?
Danish: Hvordan virker Provenge?
English: Young children are most at risk, followed by adolescents.
Danish: Små børn er mest udsat, efterfulgt af unge.
English: Bexsero received a marketing authorisation valid throughout the EU on 14 January 2013.
Danish: Bexsero fik en markedsføringstilladelse med gyldighed i hele EU den 14. januar 2013.
English: Bexsero should be used according to official recommendations.
Danish: Bexsero bør anvendes i henhold til de officielle anbefalinger.
English: A smaller supportive study was also carried out in adults and similar results were seen in this study.
Danish: Der blev desuden udført et mindre støttende studie hos voksne, hvor der sås tilsvarende resultater.
English: The number of injections given, and the interval between them, varies depending on the age of the patient.
Danish: Det antal indsprøjtninger, der gives, og intervallet mellem dem afhænger af patientens alder.
English: Although group B meningococcal disease is relatively uncommon in Europe, it is more common in certain regions of Europe.
Danish: Skønt meningokoksygdom gruppe B er forholdsvis ualmindelig i Europa, er sygdommen mere almindelig i visse regioner i Europa.
English: The second main study involved 1,631 adolescents aged between 11 and 17.
Danish: Det andet hovedstudie omfattede 1 631 unge mellem 11 og 17 år.
English: Further information on Bexsero can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Bexsero findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Bexsero
Danish: Andre oplysninger om Bexsero
English: The first main study involved 2,627 children who were two months old when the study started.
Danish: Det første hovedstudie omfattede 2 627 børn, som var to måneder gamle ved studiets start.
English: As for all medicines, data on the use of Bexsero are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Bexsero løbende overvåget.
English: What measures are being taken to ensure the safe and effective use of Bexsero?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bexsero?
English: The European Medicines Agency decided that Bexsero's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Bexsero opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: This means that the proteins are fixed onto a compound containing aluminium, to stimulate a better immune response.
Danish: Det vil sige, at proteinerne er bundet til en aluminiumholdig forbindelse for at forstærke immunresponsen.
English: Side effects reported with Bexsero are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Bexsero vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Why is Bexsero authorised in the EU?
Danish: Hvorfor er Bexsero godkendt i EU?
English: Bexsero (meningococcal group B vaccine [rDNA, component, adsorbed])
Danish: Bexsero (meningokok gruppe B-vaccine [rDNA, komponent, adsorberet])
English: An overview of Bexsero and why it is authorised in the EU
Danish: En oversigt over Bexsero og hvorfor det er godkendt i EU
English: For more information about using Bexsero, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere information om anvendelsen af Bexsero, kan du læse indlægssedlen, eller kontakte lægen eller apoteket.
English: What is Bexsero and what is it used for?
Danish: Hvad er Bexsero, og hvad anvendes det til?
English: What are the risks associated with Bexsero?
Danish: Hvilke risici er der forbundet med Bexsero?
English: 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).
Danish: 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).
English: 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).
Danish: Virkningen af at give en, to eller tre doser af Bexsero (med mindst en måneds mellemrum) blev sammenlignet med at give placebo (virkningsløs behandling).
English: 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.
Danish: Bexsero gives som en dyb injektion i en muskel, helst i skuldermusklen, eller i lårmusklen hos børn på under to år.
English: 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.
Danish: Virkningerne af tre doser af Bexsero med to måneders mellemrum sammen med andre sædvanlige børnevaccinationer blev sammenlignet med de sædvanlige vaccinationer alene.
English: 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).
Danish: 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).
English: Bexsero is available as a suspension for injection in a pre-filled syringe and can only be obtained with a prescription.
Danish: Bexsero fås som injektionsvæske, suspension, i en fyldt sprøjte og udleveres kun på recept.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Bexsero has been shown to produce a robust immune response to N. meningitidis group B and the risks are acceptable.
Danish: Bexsero er påvist at være effektivt til at frembringe en pålidelig immunrespons mod N. meningitidis gruppe B, og risiciene er acceptable.
English: 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.
Danish: 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.
English: How is Bexsero used?
Danish: Hvordan anvendes Bexsero?
English: 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.
Danish: 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.