FrancophonIA/ELRC3.0 huggingface dataset:
English: “Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).”
Danish: ”Data fra kliniske studier har vist, at dobbelthæmning af renin-angiotensin-aldosteronsystemet (RAAS) gennem kombinationsbehandling med ACE-hæmmere, angiotensin II-receptorantagonister eller aliskiren er forbundet med en højere hyppighed af bivirkninger som hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt) sammenlignet med brug af et enkelt RAAS-virkende lægemiddel (se pkt.
English: • “if you are taking either of the following classes of medicines used to treat high blood pressure: - an ACE-inhibitor such as enalapril, lisinopril, ramipril.
Danish: ”hvis du tager nogen af følgende typer lægemidler, som bruges til at behandle for højt blodtryk: - en ACE-hæmmer som f.eks. enalapril, lisinopril, ramipril eller - en angiotensin II-receptorblokker, som f.eks. valsartan, telmisartan, irbesartan
English: For all ACE-inhibitors with wording in section 4.1 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”.
Danish: 4.1 om, at de kan anvendes alene eller i kombination med andre antihypertensiva, skal følgende krydsreference tilføjes: ”(se pkt.
English: For all ACE-inhibitors with wording in section 4.2 stating that they can be used alone or in combination with other antihypertensive agents, the following cross-reference should be added: “(see sections 4.3, 4.4, 4.5 and 5.1)”.
Danish: 4.2 om, at de kan anvendes alene eller i kombination med andre antihypertensiva, skal følgende krydsreference tilføjes: ”(se pkt.
English: London, 19 March 2009 Doc.
Danish: London, den 19. marts 2009 Ref. dok.
English: Ref. EMEA/156698/2009
Danish: EMEA/291361/2009
English: Patients were either given Cylatron for up to five years or received no treatment.
Danish: Patienterne fik Cylatron i op til fem år eller modtog ikke nogen behandling.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Danish: Brevet fra virksomheden, hvori man underretter EMEA om tilbagetrækning af ansøgningen, er tilgængeligt her.
English: What is Cylatron?
Danish: Hvad er Cylatron?
English: The effects of Cylatron were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Cylatron blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The main measure of effectiveness was the how long the patients survived until the disease came back.
Danish: Det primære effektmål var den tid, patienterne overlevede, indtil deres sygdom vendte tilbage.
English: Questions and answers on the withdrawal of the marketing application for Cylatron
Danish: Spørgsmål og svar i forbindelse med tilbagetrækning af ansøgningen om markedsføringstilladelse for Cylatron
English: It was also concerned that, although the medicine showed some effects in delaying the return of the cancer, it had not been shown to be effective in increasing how long the patients survived.
Danish: Det var også bekymret over, at lægemidlet, selv om det viste nogle tegn på at forsinke kræftens tilbagevenden, ikke havde vist sig at være effektivt med hensyn til at forlænge den tid patienterne overlevede.
English: Cylatron was studied in one main study involving 1,256 adults with stage III melanoma.
Danish: Cylatron blev undersøgt i én hovedundersøgelse med 1.256 voksne med fase III melanom.
English: The CHMP had concerns over side effects of Cylatron, particularly fatigue (tiredness) and depression.
Danish: CHMP havde visse betænkeligheder i forbindelse med bivirkningerne af Cylatron, særlig træthed og depression.
English: What were the main concerns of the CHMP?
Danish: Hvad var CHMP's største betænkeligheder?
English: On 11 March 2009, SP Europe officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cylatron for the adjuvant treatment of stage III melanoma.
Danish: Den 11. marts 2009 meddelte SP Europe officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at man ønsker at trække sin ansøgning om markedsføringstilladelse for Cylatron til tillægsbehandling af fase III melanom tilbage.
English: What is happening with PegIntron and ViraferonPeg for the treatment of hepatitis C and with IntronA for the treatment of malignant melanoma?
Danish: Hvad sker der med PegIntron og ViraferonPeg til behandling af hepatitis C og med IntronA til behandling af malignt melanom?
English: This withdrawal of application has no consequences on the use of PegIntron, ViraferonPeg and IntronA in their authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Tilbagetrækningen af ansøgningen får ingen konsekvenser for anvendelsen af PegIntron, Viraferon og IntronA til de godkendte indikationer, for hvilke benefit/risk-forholdet forbliver uændret.
English: This decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
Danish: Dette bevirker, at stoffet udskilles langsommere af kroppen, så medicinen ikke skal gives så ofte.
English: What was Cylatron expected to be used for?
Danish: Hvad forventedes Cylatron anvendt til?
English: Peginterferon alfa-2b has been authorised in the European Union (EU) since May 2000 as PegIntron and ViraferonPeg for the treatment hepatitis C. Unpegylated interferon alfa-2b has also been authorised in the EU since March 2000 as IntronA.
Danish: Peginterferon alfa-2b har været tilladt i EU siden maj 2000 som PegIntron og ViraferonPeg til behandling af hepatitis C. Upegyleret interferon alfa-2b har også været godkendt i EU siden marts 2000 som IntronA.
English: In melanoma, interferon alfa-2b is thought to work by suppressing the growth and multiplication of cancerous cells, by causing these cells to die and by stimulating the immune system (the body's natural defences) to attack and kill the cancer cells.
Danish: I melanomer menes interferon alfa-2b at virke ved at undertrykke væksten og delingen af kræftceller, ved at forårsage, at disse celler dør, og ved at stimulere immunsystemet, kroppens eget forsvar, til at angribe og dræbe kræftcellerne.
English: ‘Stage III' means that some cancer cells have spread to the lymph nodes (part of the lymphatic system that drains fluids from the body's tissues).
Danish: "Fase III" betyder, at nogle kræftceller har spredt sig til lymfekirtlerne (del af lymfesystemet, der dræner væske fra kroppens væv).
English: Melanoma is a type of skin cancer affecting cells called melanocytes.
Danish: Melanom er en form for hudkræft, der rammer celler kaldet melanocyter.
English: Cylatron is a powder and solvent that is made up into a solution for injection.
Danish: Cylatron er et pulver og en solvens, der skal forberedes til en opløsning til injektion.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Danish: Når CHMP har afgivet en udtalelse, går der som regel cirka to måneder, før EuropaKommissionen udsteder en markedsføringstilladelse.
English: When the study began, all of the patients had recently had surgery to remove lymph nodes containing melanoma cells.
Danish: Da undersøgelsen begyndte, var alle patienterne for nylig blevet opereret for at fjerne lymfekirtler indeholdende melanomceller.
English: Cylatron was expected to be used in adults with stage III (advanced) melanoma as an add-on treatment after surgery, to prevent the disease from coming back.
Danish: Cylatron forventedes anvendt til voksne med fase III (fremskredent) melanom som en tillægsbehandling efter kirurgi for at forhindre sygdommen i at komme tilbage.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Danish: Efter gennemgangen af den oprindelige dokumentation udarbejder CHMP på dag 120 en liste over spørgsmål, som sendes til virksomheden.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cylatron could not have been approved for adjuvant treatment of stage III melanoma.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Cylatron ikke kunne have været godkendt til tillægsbehandling af fase III melanom.
English: IntronA is authorised for the treatment of malignant melanoma after surgery, along with other diseases.
Danish: IntronA er godkendt til behandling af malignt melanom efter kirurgi samt andre sygdomme.
English: How is Cylatron expected to work?
Danish: Hvordan forventes Cylatron at virke?
English: Cylatron was expected to be given to patients whose lymph nodes contained melanoma cells as visible under a microscope, but not when the cancer had caused the lymph nodes to become large enough to be felt through the skin.
Danish: Cylatron forventedes givet til patienter, hvis lymfekirtler indeholdt melanomceller, som var synlige under mikroskop, men ikke når kræften havde forårsaget en forstørrelse af lymfekirtlerne, så de kunne mærkes gennem huden.
English: It consists of a substance called interferon alfa-2b, which has been ‘pegylated' (coated with a chemical called polyethylene glycol).
Danish: Det består af et stof kaldet interferon alfa-2b, der er blevet "pegyleret" (overtrukket med det kemiske stof polyethylenglycol).
English: International non-proprietary name (INN): peginterferon alfa-2b
Danish: Internationalt fællesnavn (INN): peginterferon alfa-2b
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Cylatron?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Cylatron eller i programmer for anvendelse af Cylatron med særlig udleveringstilladelse?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate programmes with Cylatron.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser med Cylatron eller i programmer for anvendelse med særlig udleveringstilladelse.
English: The active substance in Cylatron, peginterferon alfa-2b, belongs to the group ‘interferons'.
Danish: Det aktive stof i Cylatron, peginterferon alfa-2b, er et middel, som tilhører gruppen "interferoner".
English: It contains the active substance peginterferon alfa-2b.
Danish: Det indeholder det aktive stof peginterferon alfa 2b.
English: EU number
Danish: EU-nummer
English: Invented name Strength Pharmaceutical
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage
English: Package size
Danish: Pakningsstørrelse
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: Box 1711
Danish: P.O. Box 1711
English: Modified-release capsule, hard
Danish: Modificeret udløsning kapsel, hård
English: Intramuscular use intravenous use
Danish: Intramuskulær anvendelse intravenøs anvendelse
English: PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568
Danish: Grækenland PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI
English: Modified-release tablet
Danish: Tablet med modificeret udløsning
English: Gebouw Jupiter Herikerbergweg 100 Postbus 12021
Danish: Gebouw Jupiter Herikerbergweg
English: --1 Inactivated influenza A virus/human, strain A/Jena/VI5258/2009(H1N1)pdm09 ≥ 16 HU* *HU = haemagglutinating units
Danish: --1 Inaktiveret influenza A-virus/human Stamme: A/Jena/VI5258/2009(H1N1)pdm09 ≥ 16 HU*
English: Annex A
Danish: Bilag A
English: Packaging Content
Danish: Indgivelsesvej Emballage Indhold Pakningsstørrelse
English: EU (MA) Number Invented name
Danish: EU-nummer
English: Target species
Danish: *HE = hæmagglutinerende enheder
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, administrationsveje, indehavere af markedsføringstilladelser i medlemsstaterne
English: 1 cartridge and 1 pen
Danish: 1 cylinderampul og 1 pen
English: Content (concentration)
Danish: Lægemiddelform Administration Emballage Indhold (Koncentration)
English: 3 cartridges
Danish: 3 cylinderampuller
English: 1 cartridge
Danish: 1 cylinderampul
English: This approach offers the highest degree of consumer protection
Danish: Denne fremgangsmåde giver den højeste grad af beskyttelse af forbrugeren
English: The responses were submitted on 17 June 2004.
Danish: Besvarelserne blev indleveret den 17. juni 2004.
English: Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS
Danish: Avda.De Europa, 20b Parque Empresarial La Moraleja 28108 ALCOBENDAS Spanien
English: 2900 AA CAPELLE AAN DEN IJSSEL The Netherlands
Danish: 2900 AA CAPELLE AAN DEN IJSSEL Nederlandene
English: A further 2 animals served as untreated controls.
Danish: Yderligere to dyr fungerede som ubehandlede kontroller.
English: Conclusions and recommendations
Danish: Konklusioner og anbefalinger
English: The remaining 4 sheep (group 1) served as untreated controls.
Danish: De resterende fire får (gruppe 1) fungerede som ubehandlede kontroller.
English: Introduction and Background
Danish: Indledning og baggrund
English: Discussion
Danish: Diskussion
English: Group 3 animals were sacrificed at day 35 after treatment.
Danish: Dyrene i gruppe 3 blev aflivet på dag 35 efter behandlingen.
English: Withdrawal period (meat and milk)
Danish: Tilbageholdelsestid (kød og mælk)
English: Therefore, the recommendation of a 70-day withdrawal period applies to both doses.
Danish: Anbefalingen af en 70 dages tilbageholdelsestid gælder derfor begge doseringer.
English: 183 25 Täby Sweden
Danish: 183 25 Täby Sverige
English: 45 days
Danish: 45 dage
English: Neither the second nor third studies are suitable for the determination of a withdrawal period following subcutaneous administration.
Danish: Hverken den anden eller den tredje undersøgelser er egnet til fastsættelse af en tilbageholdelsestid efter subkutan administration.
English: 76139 Karlsruhe Germany
Danish: 76139 Karlsruhe Tyskland
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ROUTE OF ADMINISTRATION, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE CONCERNED MEMBER STATES, ICELAND AND NORWAY
Danish: LISTE OVER NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ, DYREARTER OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I DE BERØRTE MEDLEMSSTATER, ISLAND OG NORGE
English: The product has been authorised in the EU Member States and EEA/EFTA States listed in Annex I as an injectable solution for intramuscular and/or subcutaneous administration.
Danish: Produktet er godkendt i de i bilag I opførte EU-medlemsstater og EEA/EFTA-stater som injektionsvæske til intramuskulær og/eller subkutan administration.
English: For the referral procedure, the representative of the Marketing Authorisation Holder presented three studies.
Danish: Til behandlingen af indbringelsen forelagde repræsentanten for indehaveren af markedsføringstilladelsen tre undersøgelser.
English: The third study was a re-analysis of injection site tissue from the second study due to the high variability of the results obtained.
Danish: I den tredje undersøgelse foretoges en reanalyse af væv fra injektionsstedet fra den anden undersøgelse på grund af den store variation i de opnåede resultater.
English: Only where muscle is not a target tissue and hence there is no MRL for muscle should an ADI approach be considered.
Danish: Kun hvor muskel ikke er et målvæv og der derfor ikke foreligger en MRL-værdi for muskel, bør en fremgangsmåde byggende på ADI-værdier overvejes.
English: 2.2 Calculation of withdrawal periods
Danish: Beregning af tilbageholdelsestider
English: 18 2650 Hvidovre Denmark
Danish: 18 2650 Hvidovre Danmark
English: Product trade name
Danish: Produktets handelsnavn
English: The withdrawal periods set for edible tissues of ovine species by the different Member States diverge significantly, from 35 to 70 days.
Danish: De tilbageholdelsestider, der af de forskellige medlemsstater er fastsat for spiseligt væv fra får, er stærkt afvigende, fra 35 til 70 dage.
English: With respect to doramectin administered subcutaneously the studies reviewed did not provide reliable data from which a valid calculation could be made.
Danish: Hvad angår doramectin administreret subkutant indeholdt de gennemgåede undersøgelser ikke pålidelige data, der gav mulighed for en holdbar beregning.
English: Comparison of the data from groups 2 and 3 indicated that administration of the second dose did not affect the depletion profile in edible tissue at withdrawal times around 35 days.
Danish: En sammenligning af data fra gruppe 2 og 3 viste, at administration af den anden dosis ikke påvirkede udtyndingsprofilen i spiseligt væv ved tilbageholdelsestider på omkring 35 dage.
English: Doramectin was included in Annex I of Council Regulation (EEC) No 2377/90 and the following maximum residue limits were established for ovine species:
Danish: Doramectin var omfattet af bilag I til Rådets forordning (EØF) nr. 2377/90, og følgende maksimalgrænseværdi for restkoncentrationer blev fastsat for får:
English: Strength Pharmaceutical form
Danish: Farmaceutisk form
English: In the group 2 animals given two doses, the injection sites contained the highest residues followed by liver and fat.
Danish: I de dyr i gruppe 2, der modtog to doser, fandtes de højeste restkoncentrationer på injektionsstedet, efterfulgt af lever og fedt.
English: Pfizer Ltd, Sandwich, Kent, CT13 9NJ, UK
Danish: Pfizer Ltd, Sandwich, Kent, CT13 9NJ Det Forenede Kongerige
English: Pfizer Italia SRL Via Valbondione 113 00188 Roma
Danish: Pfizer Italia SRL Via Valbondione 113 00188 Rom Italien
English: The CVMP had previously assessed doramectin in respect to the establishment of maximum residue limits (MRLs) in accordance with Council Regulation 2377/90.
Danish: CVMP havde tidligere vurderet doramectin med hensyn til fastsættelse af maksimalgrænseværdier for restkoncentrationer (MRL-værdier) i henhold til Rådets forordning 2377/90.
English: The questions identified related to the withdrawal periods and were submitted to the Marketing Authorisation Holders on 16 February 2004.
Danish: Spørgsmålene, der vedrørte tilbageholdelsestiderne, blev den 16. februar 2004 forelagt indehaverne af markedsføringstilladelserne.
English: A withdrawal period of 182 days was calculated, but in the opinion of the CVMP this approach is not sustainable as there are no actual time point slaughter studies to confirm this prediction and extrapolation from the concentration of residues found in the samples at the injection site to predict an adequate withdrawal period is difficult.
Danish: Der beregnedes en tilbageholdelsestid på 182 dage, men efter CVMP's opfattelse er denne fremgangsmåde ikke holdbar, da der ikke er nogen undersøgelse med et faktisk slagtningstidspunkt til bekræftelse af denne antagelse, og da det er vanskeligt ud fra de fundne restkoncentrationer i prøverne fra injektionsstedet at ekstrapolere til en passende tilbageholdelsestid.
English: Although, a lower dose of 200 g/kg bw is also indicated in a number of Member States as well as the higher dose of 300 g/kg bw, no residues data was provided for this lower dose.
Danish: Skønt der i en række medlemsstater er indiceret en laveste dosering på 200 g/kg kropsvægt ud over den højere dosering på 300 g/kg kropsvægt, er der ikke forelagt restkoncentrationsdata for denne lavere dosis.
English: Withdrawal period for milk 60 days for heifers, reindeer and animals during the dry period
Danish: Tilbageholdelsestid for mælk 60 dage for kvier, rensdyr og dyr i goldperioden
English: A simplified approach to the residues at the injection site is not possible as residues were above the MRL of 20 μg/kg in most of the samples taken at the last period in which the animals were slaughtered (56 days).
Danish: Forenklet behandling af restkoncentrationerne på injektionsstedet er ikke mulig, da restkoncentrationerne var over MRL-værdien på 20 µg/kg i størstedelen af de prøver der udtoges i den sidste periode, hvor dyrene blev slagtet (56 dage).
English: Pfizer Corp. Austria Seidengasse 33-35 1071 Wien
Danish: Pfizer Corp. Østrig Seidengasse 33-35 1071 Wien Østrig
English: Dectomax injectable solution contains doramectin, which is a semi-synthetic compound of the avermectin family, intended for the treatment of internal and external parasites in cattle, sheep, pigs and reindeer, excluding lactating animals producing milk for human consumption.
Danish: Dectomax opløsning til injektion indeholder doramectin, der er en halvsyntetisk forbindelse af avermectin-gruppen, bestemt til behandling af interne og eksterne parasitter i kvæg, får, svin og rensdyr, bortset fra lakterende dyr, der producerer mælk til konsum.
English: The CVMP working paper on injection site residues (III/5933/94-EN) recommends that the injection site and its residues be treated as “normal” muscle where one of the target tissues is muscle.
Danish: I CVMP's arbejdsdokument om restkoncentrationer på injektionssteder (III/5933/94-EN) anbefales at injektionsstedet og dets restkoncentrationer behandles som "normal" muskel, når muskler hører til målorganerne.
English: Denmark Pfizer Aps Lautrupvang 8
Danish: Danmark Pfizer Aps Lautrupvang 8
English: The CVMP during its meeting of 10-12 February 2004 initiated a referral procedure under Article 34 of Council Directive 2001/82/EC for Dectomax injectable solution products containing doramectin.
Danish: CVMP indledte på sit møde den 10.-12. februar 2004 en indbringelsesprocedure i henhold til artikel 34 af Rådets direktiv 2001/82/EF for Dectomax opløsning til injektionspræparater indeholdende doramectin.
English: The withdrawal period should be based on residue depletion to below the MRL at the injection site.
Danish: Tilbageholdelsestiden bør baseres på udtynding af restkoncentrationerne til et punkt under MRL-værdien på injektionsstedet.
English: For the first study, statistical calculation of the withdrawal period for injection site tissue following intramuscular injection in accordance with EMEA/CVMP/036/95-FINAL gives a period of 70 days (rounded to whole weeks).
Danish: For den første undersøgelse giver statistisk beregning af tilbageholdelsestiden for væv fra injektionsstedet efter intramuskulær injektion i henhold til EMEA/CVMP/036/95-FINAL en periode på 70 dage (afrundet til hele uger).
English: In fat, residues were below 8 μg/kg at all remaining time-points.
Danish: I fedt lå restkoncentrationen under 8 µg/kg på alle øvrige tidspunkter.
English: Following extensive re-homogenisation of the remaining injection site tissue (38-204 g) four 2.5 g sub-samples were analysed per animal for doramectin determination.
Danish: Efter omfattende rehomogenisering af det resterende væv fra injektionsstedet (38-204 g) blev fire 2,5 grams delprøver pr. dyr analyseret for doramectin.
English: Not to be used later than 60 days prior to expected calving.
Danish: Må ikke anvendes senere end 60 dage før forventet kælvningstidspunkt.