FrancophonIA/ELRC3.0 huggingface dataset:
English: Other side effects are reduced activity and lack of appetite in 10-20% of the pigs on the day of vaccination and/or a temporary swelling (maximum diameter: 10 cm) for up to two weeks at the injection site.
Danish: Andre bivirkninger er nedsat aktivitet og manglende ædelyst hos 10-20 % af grisene på vaccinationsdagen og/eller forbigående hævelse på injektionsstedet (med en diameter på højst 10 cm) i indtil to uger.
English: To maintain the immunity, a single injection of one dose should be carried out 2 - 4 weeks before each subsequent farrowing.
Danish: Til opretholdelse af immunitet gives én dosis 2-4 uger inden hver efterfølgende faring.
English: In the study of the duration of effect, based on antibody levels, it was shown that revaccination with a single dose resulted in a clear booster response (that is, the resultant antibody levels were even higher than after the basic vaccination).
Danish: I undersøgelsen af virkningens varighed, baseret på antistofmængden, blev det påvist, at revaccination med en enkelt dosis gav en klar booster-reaktion (dvs. endnu større antistofdannelse end ved basisvaccinationen).
English: Information on the prescription status of this product may be found on the outer package.
Danish: Oplysningerne om udleveringsbestemmelserne for dette lægemiddel findes på den ydre emballage.
English: The withdrawal period for Porcilis AR-T DF for pigs is zero days.
Danish: Tilbageholdelsestiden for Porcilis AR-T DF til grise er nul dage.
English: When the sow is injected, this small exposure helps the pig's immune system to recognise and attack the bacteria.
Danish: Når soen får injektionen, vil denne lille påvirkning bevirke, at soens immunsystem genkender og angriber bakterierne.
English: When exposed to any of these bacteria later in life, the pig will either not become infected or have a much less serious infection.
Danish: Når soen senere udsættes for sådanne bakterier, vil soen enten ikke blive inficeret, eller også bliver infektionen ikke nær så alvorlig.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Porcilis AR-T DF to Intervet International B.V. on 16 November 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Porcilis AR-T DF til Intervet International B.V.
English: An active ingredient of Porcilis AR-T DF, Pasteurella multocida toxin, is produced by a method known as ‘recombinant technology'.
Danish: Det aktive stof i Porcilis AR-T DF, Pasteurella multocida-toksin, fremstilles ved hjælp af en metode, der kaldes ”rekombinant teknologi”.
English: Progressive atrophic rhinitis is caused by toxins from the bacteria Pasteurella multocida.
Danish: Progressiv atrofisk rhinitis skyldes toksiner fra bakterien Pasteurella multocida.
English: The trials showed good protection against the clinical signs of progressive atrophic rhinitis.
Danish: Undersøgelserne viste, at der opnås god beskyttelse mod de kliniske tegn på progressiv atrofisk rhinitis.
English: The Pasteurella multocida toxin is made by a bacterium cell that has received a gene (DNA), which makes it able to produce Pasteurella multocida toxoid, a genetically modified form of toxin which has adequate immunogenic activity and which is free from the toxic properties.
Danish: Pasteurella multocida-toksinet produceres af en bakteriecelle, der har fået indsat et gen (dna), der sætter den i stand til producere Pasteurella multocida-toksoid, en genetisk modificeret form af toksinet med tilstrækkelig immunogen virkning, men uden toksiske egenskaber.
English: This immunity is passed onto the sow's piglets through her colostrum.
Danish: Immuniteten overføres fra soen til smågrisene gennem råmælken.
English: The first dose is followed by a second injection 4 weeks later.
Danish: Der gives endnu en injektion 4 uger efter den første dosis.
English: The main measure of effectiveness was the amount of antibodies to Bordetella bronchiseptica and also to Pasteurella multocida toxin.
Danish: Det vigtigste mål for virkningen var mængden af antistoffer mod Bordetella bronchiseptica og mod Pasteurella multocida-toksin.
English: Porcilis AR-T DF has been studied in sows, where it was compared with another vaccine for progressive atrophic rhinitis.
Danish: Porcilis AR-T DF er blevet undersøgt hos søer, hvor den blev sammenlignet med en anden vaccine mod progressiv atrofisk rhinitis.
English: Vaccine to reduce atrophic rhinitis in piglets
Danish: Vaccine til mindskelse af atrofisk rhinitis hos smågrise
English: Other information about Porcilis AR-T DF:
Danish: Andre oplysninger om Porcilis AR-T DF:
English: Porcilis AR-T DF can cause a temporary increase in body temperature of 1.5°C, and in some pigs of up to 3°C on the day of vaccination or the following day.
Danish: Porcilis AR-T DF kan medføre en forbigående temperaturforhøjelse på 1,5℃, hos nogle grise op til 3°C,
English: In this study, blood was taken from piglets in each litter born from each sow, and tested for antibodies to Pasteurella multocida toxin and Bordetella bronchiseptica.
Danish: I undersøgelsen blev blodprøver fra smågrisene i hvert kuld fra hver so testet for antistoffer mod Pasteurella multocida-toksin og mod Bordetella bronchiseptica.
English: Porcilis AR-T DF contains a non-toxic recombinant derivative (see later) of the Pasteurella multocida toxin and also inactivated Bordetella bronchiseptica bacterial cells.
Danish: Porcilis AR-T DF indeholder et non-toksisk rekombinant derivat (se nedenfor) af Pasteurella multocida-toksin samt inaktiverede celler af bakterien Bordetella bronchiseptica.
English: The piglets had comparable levels of antibodies against progressive atrophic rhinitis as obtained with another approved vaccine.
Danish: Smågrisene dannede antistoffer mod progressiv atrofisk rhinitis i en mængde svarende til den, der blev opnået med en anden godkendt vaccine.
English: Porcilis AR-T DF is used to reduce the clinical signs of progressive atrophic rhinitis (a disease where the nose tissues become infected and die) in piglets.
Danish: Porcilis AR-T DF anvendes til at mindske de kliniske tegn på progressiv atrofisk rhinitis (en sygdom, hvor vævet i trynen bliver inficeret og dør) hos smågrise.
English: Porcilis AR-T DF is given as a dose of 2 ml by intramuscular (into a muscle) injection to female pigs of 18 weeks of age and older.
Danish: Porcilis AR-T DF gives i en dosis på 2 ml ved intramuskulær injektion (injektion i en muskel) til søer på 18 uger og derover.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Porcilis AR-T DF exceed the risks for the reduction of clinical signs of progressive atrophic rhinitis in piglets, by passive oral immunisation with colostrum from dams actively immunised with the vaccine, and recommended that Porcilis AR-T DF should be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Porcilis AR-T DF opvejer risiciene med hensyn til mindskelse af de kliniske tegn på progressiv atrofisk rhinitis hos smågrise ved hjælp af passiv oral immunisering med råmælk fra søer, der er aktivt immuniseret med vaccinen.
English: Porcilis AR-T DF is a vaccine for use in (female) pigs to reduce atrophic rhinitis in their piglets.
Danish: Porcilis AR-T DF er en vaccine, der gives til søer for at mindske atrofisk rhinitis hos deres smågrise.
English: What is the risk associated with Porcilis AR-T DF?
Danish: Hvilken risiko er der forbundet med Porcilis AR-T DF?
English: Why has Porcilis AR-T DF been approved?
Danish: Hvorfor blev Porcilis AR-T DF godkendt?
English: The first injection should be given 6 weeks before the expected date of farrowing (giving birth to the piglets).
Danish: Den første injektion gives 6 uger før forventet faring.
English: The vaccine is given to sows (female pigs) only.
Danish: Vaccinen gives kun til søerne.
English: How has Porcilis AR-T DF been studied?
Danish: Hvordan blev Porcilis AR-T DF undersøgt?
English: What is Porcilis AR-T DF?
Danish: Hvad er Porcilis AR-T DF?
English: Porcilis AR-T DF is a suspension for injection which contains a non-toxic recombinant derivative (see ‘How does Porcilis AR-T DF work?')
Danish: Porcilis AR-T DF er en injektionsvæske, suspension, der indeholder et non-toksisk rekombinant derivat (se afsnittet ”Hvordan virker Porcilis AR-T DF?”) af Pasteurella multocida-toksin og inaktiverede Bordetella bronchiseptica-celler.
English: The length of time that Porcilis AR-T DF is effective has also been studied.
Danish: Desuden blev det undersøgt, hvor længe Porcilis AR-T DF virkede.
English: How does Porcilis AR-T DF work?
Danish: Hvordan virker Porcilis AR-T DF?
English: What is Porcilis AR-T DF used for?
Danish: Hvad anvendes Porcilis AR-T DF til?
English: What benefit has Porcilis AR-T DF shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Porcilis AR-T DF?
English: The applicant had requested a re-examination of the opinion.
Danish: Ansøgeren havde anmodet om fornyet overvejelse af udtalelsen.
English: The company that applied for authorisation is Cytonet GmbH & Ci KG.
Danish: Den virksomhed, der har indgivet ansøgningen, er Cytonet GmbH & Ci KG.
English: The summaries of the opinion of the Committee for Orphan Medicinal Products for Heparesc can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendragene af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Heparesc findes på agenturets websted på adressen: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The effects of Heparesc were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Heparesc blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to cure, diagnose or prevent a disease.
Danish: Denne type lægemiddel indeholder celler eller væv, der er manipuleret, så de kan anvendes til at helbrede, diagnosticere eller forebygge en sygdom.
English: What was Heparesc expected to be used for?
Danish: Hvad forventedes Heparesc anvendt til?
English: The Committee thus considered that the benefits of treatment had not been sufficiently demonstrated.
Danish: Udvalget fandt således ikke, at fordelene ved behandlingen var påvist tilfredsstillende.
English: What is Heparesc?
Danish: Hvad er Heparesc?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 October 2015 EMA/684158/2015 EMEA/H/C/003750
Danish: Den 23. oktober 2015 EMA/684158/2015 EMEA/H/C/003750
English: Because Heparesc is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Danish: Da Heparesc er et lægemiddel til avanceret terapi, blev det vurderet af Udvalget For Avancerede Terapier (CAT).
English: The specific urea cycle disorders for which Heparesc was intended to be used are called carbamoylphosphate synthetase 1 deficiency, ornithine transcarbamylase deficiency, argininosuccinate synthetase deficiency (citrullinaemia type 1), argininosuccinate lyase deficiency (argininosuccinic aciduria) and arginase deficiency (hyperargininaemia).
Danish: De særlige forstyrrelser i urinstofcyklus, som Heparesc var beregnet til anvendelse ved, er carbamylfosfat syntetase 1-mangel, ornitin transcarbamylase-mangel, argininosuccinat syntetasemangel (citrullinæmi type 1), argininosuccinat lyase-mangel (argininsuccinin-aciduri) og arginasemangel (hyperargininæmi).
English: Heparesc was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 14 September 2007 for ornithine transcarbamylase deficiency, and 17 December 2010 for the other above conditions.
Danish: Heparesc blev den 14. september 2007 udpeget som "lægemiddel til sjældne sygdomme" mod ornitin transcarbamylase-mangel, og den 17. december 2010 til de øvrige ovennævnte sygdomme.
English: On 25 June 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Heparesc, intended for the treatment of urea cycle disorders.
Danish: Den 25. juni 2015 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Heparesc, der er beregnet til behandling af forstyrrelser i urinstofcyklus.
English: The CHMP had concerns about the design and conduct of the studies, which cast doubt on their results and whether these could have occurred by chance.
Danish: CHMP havde betænkeligheder ved undersøgelsernes udformning og udførelse, som skaber tvivl om resultaterne og om, hvorvidt de kan have skyldtes en tilfældighed.
English: In addition, the CHMP had concerns about the clinical relevance of the results of the tests that measured the ability to produce urea.
Danish: Desuden havde CHMP betænkeligheder ved den kliniske betydning af resultaterne af de test, der målte evnen til at producere urinstof.
English: The company presented the results of two main studies involving a total of 20 children with urea cycle disorders in which the effects of Heparesc were compared with historical results in children who had not received Heparesc treatment.
Danish: Virksomheden fremlagde resultaterne fra to hovedundersøgelser med i alt 20 børn med forstyrrelser i urinstofcyklus, hos hvem virkningerne af Heparesc blev sammenlignet med historiske resultater fra børn, der ikke var blevet behandlet med Heparesc.
English: The main measures of effectiveness were the change in the levels of 13C-labelled urea production (a test intended to show the ability to produce urea) after treatment as compared to before, and the number, length and severity of any episodes of high ammonia in the blood during the studies.
Danish: De vigtigste mål for virkningen var ændringen i koncentrationen af 13C-mærket urinstof (en test, der viser evnen til at producere urinstof) fra før til efter behandlingen, og antallet, længden og sværhedsgraden af eventuelle episoder med højt ammoniakindhold i blodet i løbet af undersøgelserne.
English: Heparesc was intended to help temporary management of these conditions in children until they are big enough to be given a liver transplant to cure them.
Danish: Heparesc var beregnet til midlertidig behandling af disse børn, indtil de er store nok til at få foretaget en levertransplantation, der helbreder dem.
English: When the medicine is injected into the portal vein leading to the liver, some of the liver cells it contains are expected to settle in the recipient's liver and start producing the missing liver enzyme, thus helping to reduce the symptoms of the disease.
Danish: Når lægemidlet indsprøjtes i portåren, der fører til leveren, forventes nogle af de leverceller, som det indeholder, at vokse fast i modtagerens lever og begynde at producere det manglende leverenzym, så symptomerne på sygdommen mindskes.
English: Both Committees confirmed their opinion that the effectiveness of Heparesc in the treatment of these disorders had not been sufficiently demonstrated.
Danish: Begge udvalg fastholdt deres udtalelse om, at virkningen af Heparesc til behandling af disse sygdomme ikke var tilfredsstillende påvist.
English: During the re-examination the CAT and CHMP looked again at the data from the company, and also consulted experts in the treatment of urea cycle disorders.
Danish: Ved den fornyede overvejelse gennemgik CAT og CHMP igen dataene fra virksomheden og forhørte sig desuden hos eksperter i behandling af forstyrrelser i urinstofcyklus.
English: Heparesc is made of liver cells from an organ donor who can produce the enzyme that is missing in patients with urea cycle disorders.
Danish: Heparesc fremstilles af leverceller fra en organdonor, som kan producere det enzym, der mangler hos patienter med forstyrrelser i urinstofcyklus.
English: Heparesc was developed as a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Danish: Heparesc blev udviklet som et lægemiddel til avanceret terapi af typen "somatisk celleterapiprodukt".
English: How is Heparesc expected to work?
Danish: Hvordan forventes Heparesc at virke?
English: After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed the refusal of the marketing authorisation on 22 October 2015.
Danish: CHMP gennemgik begrundelsen for anmodningen og foretog en fornyet overvejelse af den oprindelige udtalelse, men bekræftede den 22. oktober 2015 afslaget på ansøgningen om markedsføringstilladelse.
English: Heparesc was to be used for the treatment of children from birth up to 3 years of age with specific urea cycle disorders.
Danish: Heparesc forventedes anvendt til behandling af børn fra fødslen indtil 3 år med bestemte forstyrrelser i urinstofcyklus.
English: The medicine was to be given by slow injection through a tube inserted by a surgical procedure into the portal vein (a vein leading directly to the patient's liver).
Danish: Det var hensigten, at lægemidlet skulle gives ved langsom indsprøjtning gennem en indopereret sonde i portåren (en vene, der fører direkte til patientens lever).
English: Therefore, at the time of the initial evaluation, the CHMP was of the opinion that the benefits of Heparesc did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: På tidspunktet for den oprindelige vurdering var CHMP derfor af den opfattelse, at fordelene ved Heparesc ikke var større end risiciene, og anbefalede afslag på ansøgning om markedsføringstilladelse.
English: As a result, toxic waste products build up in the blood in the form of ammonia which can lead to brain damage, convulsions (fits), coma and death.
Danish: Som følge heraf ophobes giftige produkter i kroppen som ammoniak, hvilket kan føre til hjerneskader, krampeanfald, bevidstløshed og død.
English: Taking into account the assessments performed by the CAT, the CHMP concluded that Heparesc could not be approved for the treatment of children with urea cycle disorders.
Danish: På baggrund af CAT's vurdering konkluderede CHMP, at Heparesc ikke kunne godkendes til behandling af børn med defekt urinstofcyklus.
English: The company informed the CHMP that the refusal had no consequences for patients in clinical trials or compassionate use programmes.
Danish: Virksomheden har til CHMP oplyst, at afslaget ikke vil få konsekvenser for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse.
English: Although taking into account the challenges of developing the medicine, including the difficulty of enrolling patients due to the rarity of the disease, the CHMP therefore concluded that the benefits of Heparesc did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Danish: CHMP noterede sig udfordringerne ved udviklingen af lægemidlet, herunder vanskeligheden ved at indrullere patienter pga. sygdommens sjældenhed, men konkluderede, at fordelene ved Heparesc ikke opvejer dets risici, og fastholdt sin tidligere anbefaling om, at der bør gives afslag på udstedelse af markedsføringstilladelse.
English: These are rare inborn conditions in which the liver does not produce particular enzymes involved in removing nitrogen from the body via a substance called urea.
Danish: Ved disse svære arvelige sygdomme producerer leveren ikke bestemte enzymer, der medvirker ved fjernelsen af kvælstof fra kroppen gennem en forbindelse kaldet urinstof.
English: Heparesc is a medicine that contains living cells from the liver of a healthy donor which have been manipulated and then frozen for long-term storage.
Danish: Heparesc er et lægemiddel, der indeholder levende celler fra leveren hos en rask donor.
English: Strength Pharmaceutical Form Route of Administration
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage Pakningsstørrelse
English: Other sections
Danish: Andre punkter
English: The European Commission issued a decision on 21 February 2011.
Danish: Europa-Kommissionen traf en afgørelse den 21. februar 2011.
English: What is Tazocin?
Danish: Hvad er Tazocin?
English: Tazocin is authorised in the EU via national procedures.
Danish: Tazocin er godkendt i EU efter nationale procedurer.
English: It is used to treat a wide range of bacterial infections.
Danish: Det anvendes til behandling af en lang række bakterieinfektioner.
English: Why was Tazocin reviewed?
Danish: Hvorfor blev Tazocin vurderet igen?
English: Tazocin is also available in the EU under other trade names: Tazobac, Tazocel, Tazocilline and Tazonam.
Danish: Tazocin markedsføres ligeledes i EU under andre særnavne: Tazobac, Tazocel, Tazocilline og Tazonam.
English: Tazocin can be used to treat complicated intra-abdominal infections in children aged from two to 12 years.
Danish: Tazocin kan anvendes til behandling af komplicerede intraabdominale infektioner hos børn fra 2 til 12 år.
English: On 12 June 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Tazocin in the EU.
Danish: Den 12. juni 2009 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Tazocin i EU.
English: The CHMP agreed that Tazocin should be used to treat the following infections in adults and adolescents:
Danish: CHMP besluttede, at Tazocin skulle anvendes til behandling af følgende infektioner hos voksne og unge:
English: Tazocin is a medicine that contains the active substances piperacillin and tazobactam.
Danish: Tazocin er et lægemiddel, der indeholder de aktive stoffer piperacillin og tazobactam.
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Danish: Dette forhindrer bakterierne i at bygge deres cellevægge, og de bliver derfor dræbt.
English: The European Medicines Agency has completed a review of Tazocin.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Tazocin.
English: The Committee also harmonised other sections of the SmPC including the sections on contraindications, special warnings and pregnancy and lactation.
Danish: Udvalget harmoniserede ligeledes andre punkter i produktresuméet, herunder punkterne om kontraindikationer, særlige advarsler og fertilitet, graviditet og amning.
English: Tazocin may also be used to manage children, adolescents and adults with neutropenia (low levels of neutrophils, a type of white blood cell) who also have fever suspected to be caused by bacterial infection.
Danish: Tazocin kan også anvendes til behandling af børn, unge og voksne med neutropeni (lave niveauer af neutrofiler, som er en type hvide blodlegemer), som ligeledes har feber, der formodes at skyldes en bakterieinfektion.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Tazocin in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Tazocin i Den Europæiske Union (EU).
English: Tazocin can also be used in adults to treat bacteraemia (bacteria in the blood) that is associated with or suspected to be associated with the infections listed above.
Danish: Tazocin kan ligeledes anvendes til behandling af voksne med bakteriæmi (bakterier i blodet), som er forbundet med eller formodes at være forbundet med de infektioner, der er nævnt ovenfor.
English: Questions and answers on Tazocin and associated names (piperacillin and tazobactam, 2/0.25 g and 4/0.5 g powder for solution for infusion) EMA/656918/2010
Danish: Spørgsmål og svar vedrørende Tazocin og relaterede navne (piperacillin og tazobactam, 2/0,25 g og 4/0,5 g pulver til infusionsvæske, opløsning) EMA/656918/2010
English: Piperacillin is an antibiotic that belongs to the group ‘beta-lactams'.
Danish: Piperacillin er et antibiotikum, der tilhører gruppen "betalaktamer".
English: • complicated urinary tract infections, including pyelonephritis (kidney infection)
Danish: • komplicerede urinvejsinfektioner, herunder pyelonefritis (nyreinfektion)