FrancophonIA/ELRC3.0 huggingface dataset:
English: • Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be reconstituted in the diluent; either 1 ampoule of 1,000 doses of vaccine per 200 ml of diluent (or 1 ampoule of 2,000 doses of vaccine per 400 ml of diluent) for subcutaneous administration, or 4 ampoules of 1,000 doses of vaccine per 200 ml of diluent (or 4 ampoules of 2,000 doses of vaccines per 400 ml of diluent) for in ovo administration.
Danish: • Gentag optøning, åbning, overførsel til opløsningsmiddel og oprensningsproces for det antal ampuller som skal rekonstitueres i opløsningsmidlet: enten 1 ampul med 1000 doser vaccine per 200 ml opløsningsmiddel (eller 1 ampul med 2000 doser vaccine per 400 ml opløsningsmiddel) til subkutan administration, eller 4 ampuller med 1000 doser vaccine per 200 ml opløsningsmiddel (eller 4 ampuller med 2000 doser vaccine per 400 ml opløsningsmiddel) til in ovo- administration.
English: Shelf life of the diluent in polyvinylchloride bags: 36 months at a temperature below 30°C.
Danish: Opbevaringstid for opløsningsmidlet i polyvinylklorid poser: 36 måneder ved en temperatur under 30 °C.
English: - (polyvinylchloride) bag of 200ml, 400ml, 600ml, 800ml, 1000ml, 1200ml, 1400ml, 1600ml,
Danish: - (Polyvinylklorid)pose med 200 ml, 400 ml, 600 ml, 800 ml, 1000 ml, 1200 ml, 1400 ml,
English: Open ampoules holding them at arm's length in order to prevent any risk of injury should an ampoule break.
Danish: Åben ampullerne ved at holde dem bort fra kroppen i en arms længde for at forebygge risiko for skade, hvis en ampul skulle gå i stykker.
English: Subcutaneous route: one single injection of 0.2 ml per chicken at the age of one day.
Danish: Subkutan administration: En injektion på 0,2 ml pr. kylling, når de er en dag gamle.
English: Do not use if cloudy.
Danish: Må ikke bruges, hvis det er uklart.
English: - (glass) ampoule of 1,000 doses of vaccine, 5-ampoule carrier.
Danish: - (glas)ampul med 1000 doser vaccine, beholder med 5 ampuller.
English: • Wear protective gloves and spectacles during the ampoule thawing and opening operations.
Danish: • Bær beskyttelseshandsker og -briller, når ampullen skal optøs og åbnes.
English: Store the reconstituted vaccine at a temperature below 25°C.
Danish: Opbevar den opløste vaccine under 25 °C.
English: Discard any ampoules that have been accidentally thawed.
Danish: Ampuller, der ved et tilfælde er blevet optøet, kasseres.
English: One single injection of 0.05 ml per chicken egg at 18 days of embryonation, by in ovo route.
Danish: En injektion på 0,05 ml pr. kyllingeæg på 18. dag efter embryonering ved in ovo - administration.
English: Wear protective gloves and spectacles during the ampoule thawing and opening operations.
Danish: Bær beskyttelseshandsker og -briller, når ampullen skal optøs og åbnes.
English: In the absence of specific studies, no other veterinary medicinal product should be administered concurrently with the product.
Danish: Da der ikke foreligger specifikke studier for samtidig brug med andre veterinære lægemidler, bør dette veterinære lægemiddel ikke anvendes samtidig med andre.
English: Diluent:
Danish: Subkutant:
English: - (glass) ampoule of 2,000 doses of vaccine, 4-ampoule carrier.
Danish: - (glas)ampul med 2000 doser vaccine, beholder med 4 ampuller.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE STERILE DILUENT
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE STERIL SOLVENS
English: • Draw up 2 ml of the contents of the diluent into the syringe.
Danish: • 2 ml af indholdet af opløsningsmidlet suges op i sprøjten.
English: Read the package leaflet supplied with the vaccine vial before use.
Danish: Læs indlægssedlen inden brug.
English: PACKAGE LEAFLET FOR: Vaxxitek HVT+IBD suspension and solvent for suspension for injection
Danish: INDLÆGSSEDDEL TIL: Vaxxitek HVT+IBD suspension og solvens til injektionsvæske, suspension
English: STERILE DILUENT
Danish: STERIL SOLVENS
English: Store the diluent below 30°C.
Danish: Opbevar opløsningsmidlet under 30 °C.
English: Vaxxitek HVT+IBD Suspension and solvent for suspension for injection
Danish: Vaxxitek HVT+IBD suspension og solvens til injektion (suspension)
English: 1800ml or 2400ml of diluent.
Danish: 1600ml, 1800 ml eller 2400 ml opløsningsmiddel.
English: Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Danish: Indehaver af markedsføringstilladelse Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein TYSKLAND
English: Shelf life of the non-reconstituted vaccine: 36 months at -196°C Shelf life of the reconstituted vaccine: up to 2 hours at a temperature below 25°C.
Danish: Opbevaringstid for den uopløste vaccine: 36 måneder ved -196 °C.
English: One single injection of 0.2 ml per chicken at the age of one day, by subcutaneous route.
Danish: En injektion på 0,2 ml administreres subkutant pr. kylling, når de er en dag gamle.
English: Posology
Danish: INDIKATIONER
English: Lay: Do not use in breeding birds and birds in lay.
Danish: Æglæggende fugle: Må ikke anvendes til avlsfugle og æglæggende fugle.
English: Do not use in breeding birds and birds in lay.
Danish: Må ikke anvendes til avlsfugle og æglæggende fugle.
English: 4.9 Amounts to be administered and administration route
Danish: 4.9 Dosering og indgivelsesvej Rekonstitution af vaccinen
English: PACKAGE LEAFLET FOR STERILE DILUENT
Danish: INDLÆGSSEDDEL TIL: STERIL SOLVENS
English: - (polypropylene) bottle of 200ml of diluent - (polyvinylchloride) bag of 200ml, 400ml, 600ml, 800ml, 1000ml, 1200ml, 1400ml, 1600ml,
Danish: 1 pose à 200 ml 1 pose à 400 ml 1 pose à 600 ml 1 pose à 800 ml 1 pose à 1000 ml 1 pose à 1200 ml 1 pose à 1400 ml 1 pose à 1600 ml 1 pose à 1800 ml 1 pose à 2400 ml
English: Suspension:
Danish: TILBAGEHOLDELSESTID
English: Diluent ......................................................................................................................................... qs 1 dose *Plaque forming unit
Danish: 1 dosis * Plaque forming unit
English: Sucrose
Danish: Dosering
English: 1 bag of 1800 ml.
Danish: 1600 ml, 1800 ml eller 2400 ml opløsningsmiddel.
English: The full EPAR for Palonosetron Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Palonosetron Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Palonosetron Accord.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Palonosetron Accord.
English: The Committee recommended that Palonosetron Accord be approved for use in the EU.
Danish: Udvalget anbefalede, at Palonosetron Accord godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Palonosetron Accord is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Palonosetron Accord anvendes så sikkert som muligt.
English: Palonosetron Accord should only be given before chemotherapy.
Danish: Palonosetron Accord bør kun gives inden kemoterapi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Palonosetron Accord has been shown to be comparable to Aloxi.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Palonosetron Accord er sammenligneligt med Aloxi.
English: This means that Palonosetron Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aloxi.
Danish: Det betyder, at Palonosetron Accord svarer til et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Aloxi.
English: The active substance in Palonosetron Accord, palonosetron, is a ‘5HT3 antagonist'.
Danish: Det aktive stof i Palonosetron Accord, palonosetron, er en "5HT3-antagonist".
English: No additional studies were needed as Palonosetron Accord is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Aloxi.
Danish: Der var ikke brug for yderligere undersøgelser, da Palonosetron Accord er et generisk lægemiddel, som gives ved injektion og indeholder samme aktive stof som referencelægemidlet Aloxi.
English: In children, the solution should be given by infusion into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Danish: Hos børn gives opløsningen ved infusion (drop) i en vene over 15 minutter i en dosis på 20 mikrogram pr. kilo kropsvægt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Palonosetron Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Palonosetron Accord, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: It is available as a solution for injection or infusion (drip) into a vein, which should be given by a healthcare professional about 30 minutes before the start of chemotherapy.
Danish: Det fås som en injektionsvæske eller infusion (drop) i en vene, som skal indgives af en sundhedsperson ca. 30 minutter før kemoterapien starter.
English: By blocking these receptors, Palonosetron Accord prevents the nausea and vomiting that often happen after chemotherapy.
Danish: Ved at blokere disse receptorer forebygger Palonosetron Accord den kvalme og de opkastninger, som ofte indtræder efter kemoterapi.
English: Palonosetron Accord contains the active substance palonosetron.
Danish: Palonosetron Accord indeholder det aktive stof palonosetron.
English: What are the benefits and risks of Palonosetron Accord?
Danish: Hvilke fordele og risici er der forbundet med Palonosetron Accord?
English: Other information about Palonosetron Accord
Danish: Andre oplysninger om Palonosetron Accord
English: What measures are being taken to ensure the safe and effective use of Palonosetron Accord?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Palonosetron Accord?
English: Because Palonosetron Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Palonosetron Accord er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: It is not intended to provide practical advice on how to use Palonosetron Accord.
Danish: Det er ikke en praktisk vejledning i, hvordan Palonosetron Accord bør anvendes.
English: For more information about treatment with Palonosetron Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Palonosetron Accord, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Palonosetron Accord is a medicine used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Danish: Palonosetron Accord anvendes til forebyggelse af kvalme og opkastninger forårsaget af kemoterapi (lægemidler til behandling af kræft).
English: It may be given with a corticosteroid (another type of medicine that can be used to prevent nausea and vomiting) to increase the effect.
Danish: Det kan gives sammen med et corticosteroid (en anden type lægemiddel, der kan anvendes til forebyggelse af
English: What is Palonosetron Accord and what is it used for?
Danish: Hvad er Palonosetron Accord, og hvad anvendes det til?
English: For practical information about using Palonosetron Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Palonosetron Accord, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Palonosetron Accord approved?
Danish: Hvorfor blev Palonosetron Accord godkendt?
English: How has Palonosetron Accord been studied?
Danish: Hvordan er Palonosetron Accord blevet undersøgt?
English: How does Palonosetron Accord work?
Danish: Hvordan virker Palonosetron Accord?
English: How is Palonosetron Accord used?
Danish: Hvordan anvendes Palonosetron Accord?
English: the change to the authorisation is Eli Lilly.
Danish: Virksomheden, der har indgivet ansøgningen, er Eli Lilly.
English: EMEA/H/C/000572/WS/007 EMEA/H/C/000573/W
Danish: EMEA/H/C/000552/WS/0076 EMEA/H/C/000572/WS/0076 EMEA/H/C/000573/WS/0076
English: It may request a retive opinion.
Danish: Ansøgeren anmodede om en revurdering af udtalelsen.
English: There was also insufficient evidence th time, which is important when treating a long-term condition.
Danish: Der var ligeledes ikke tilstrækkelig dokumentation for, at virkningen kunne opretholdes med tiden, som det er vigtigt ved langvarig sygdom.
English: The CHMP noted that the studies had not proven that duloxetine would provide a r the indication applied for.
Danish: CHMP konstaterede, at undersøgelserne ikke havde bevist, at duloxetin ville have en relevant fordel ved den ansøgte indikation.
English: Neurotransmitters are chemica cells to communicate with one another.
Danish: Neurotransmittere er kemiske signalstoffer, som nervecellerne anvender til deres indbyrdes kommunikation.
English: It works by preventi the neurotransmitters 5-hydroxytrypamine (also called serotonin) and no back up into nerve cells in the brain and spinal cord.
Danish: Det virker ved at forhindre, at neurotransmitterne 5-hydroxytryptamin (der også kaldes serotonin) og noradrenalin genoptages i nervecellerne i hjernen og rygmarven.
English: In addition to their approved uses, the three medicines were expected to be used to treat moderate to severe chronic (long-term) somatic pain in patients not regularly taking NSAID pain killers (nonsteroidal anti-inflammatory drugs).
Danish: Ud over de godkendte anvendelser forventedes de tre lægemidler anvendt til behandling af moderate til svære kroniske (langvarige) somatiske smerter hos patienter, der ikke regelmæssigt bruger NSAID mod smerter (non-steroide antiinflammatoriske lægemidler).
English: It does not include pain from h and intestines.
Danish: De omfatter ikke smerter fra indre organer som f.eks. mave og tarm.
English: MP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisations for the duloxetinecontaining medicines Ariclaim, Cymbalta and Xeristar.
Danish: Den 28. juli 2011 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om ændring af markedsføringstilladelsen for lægemidlerne Ariclaim, Cymbalta og Xeristar, der indeholder duloxetin.
English: Ariclaim is used to treat pain due to diabetic peripheral neuropathy (damage extremities that can occur in patients with diabetes).
Danish: Ariclaim anvendes til smerter ved diabetisk perifer neuropati (beskadigelse af nerverne i arme og ben, hvilket kan forekomme hos patienter med diabetes).
English: ts of five main studies in 839 patients with chronic somatic pain: two studies in patients with knee pain caused by osteoarthritis (swelling and pain in the joints) and three in ne or placebo (a nts taking them in combination with NSAIDs.
Danish: Virksomheden fremlagde resultater af fem hovedundersøgelser, der omfatter 839 patienter med kroniske somatiske smerter: To undersøgelser hos patienter med knæsmerter ved slidgigt (hævelse og smerter i leddene) og tre undersøgelser hos patienter med kroniske lændesmerter.
English: What were the CHMP's main concerns that led to the refusal to the
Danish: Hvori bestod de vigtigste betænkeligheder, som førte til, at CHMP anbefalede at give afslag på ansøgningen om ændring af markedsføringstilladelserne?
English: The change concerned the addition of a new e chronic somatic pain in patients not taking NSAIDs regularly.
Danish: Ændringen vedrørte tilføjelse af en ny indikation: behandling af moderate til svære somatiske smerter hos patienter, der ikke regelmæssigt bruger NSAID.
English: Somatic pain is from the body surfaces (such as skin) or
Danish: Somatiske smerter er smerter fra krop pens overflader (f.eks. huden) eller fra muskuloskeletalt væv (skeletmuskler, knogler og led).
English: What consequences does this refusal have for patients in clin compassionate use programm
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse med særlig udleveringstilladelse?
English: Since these neurotransmitters are i of pain, blocking their re-uptake into nerve cells may improve the symptoms of p
Danish: Når deres genoptagelse i nervecellerne blokeres, kan det derfor bedre smertesymptomerne.
English: By blocking their re-uptake, dul of these neurotransmitters in the spaces between these nerve cel communication between the cells.
Danish: Ved at blokere for genoptagelsen af neurotransmitterne øger duloxetin mængden af disse neurotransmittere i mellemrummene mellem nervecellerne og forbedrer derved kommunikationen mellem cellerne.
English: Ariclaim, Cymbalta and Xeristar are medicines containin
Danish: Ariclaim, Cymbalta og Xeristar er lægemidler, der indeholder det aktive stof duloxetin.
English: The CHMP therefore concluded that the benefits of d chronic somatic pain in patients not regularly taking NSAIDs had not been and recommended that
Danish: CHMP konkluderede derfor, at det ikke er påvist, at fordelene ved duloxetin opvejer risiciene til behandling af moderate til svære kroniske somatiske smerter hos patienter, der ikke regelmæssigt bruger NSAID.
English: The main measure of on an 11-point scale of the change elevant benefit in at its effect could be maintained over nformation was n elderly patients and its safety in the intended patients including the elderly.
Danish: Desuden var der brug for flere oplysninger om duloxetins virkninger hos ældre patienter og dets sikkerhed ved anvendelse hos den tilsigtede patientgruppe, herunder ældre.
English: Patients in the studies were treated with duloxeti dummy treatment) with some patie effectiveness was the change in the severity of pain, as recorded by the patients after 12 or 13 weeks of treatment.
Danish: Dette blev af patienterne registreret på en 11-punkts skala efter 12 eller 13 ugers behandling.
English: The company informed the CHMP that there are currently no ongoing clinical t Cymb
Danish: Virksomheden meddelte CHMP, at der på nuværende tidspunkt ikke gennemføres kliniske undersøgelser med Ariclaim, Cymbalta eller Xeristar hos patienter med kroniske somatiske smerter i Europa.
English: The medicines are expected to work in the same way they do in diabetic periphera active substance duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Danish: Det aktive stof duloxetin hæmmer genoptagelsen af serotonin og noradrenalin.
English: uloxetine in the treatment of moderate to severe shown to outweigh its risks the change to the marketing authorisations be refused.
Danish: Udvalget konkluderede imidlertid, at dets betænkeligheder fortsat ikke var tilstrækkeligt imødekommet, og fastholdt sin oprindelige negative udtalelse, som anbefalede afslag på ansøgningen om ændring af markedsføringstilladelserne.
English: Page 2/2
Danish: Den 17. november 2011
English: The company that applied for examination of the opinion within 15 days of receipt of notification of this nega
Danish: Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en revurdering af den første udtalelse og fastholdt den 17. november 2011 afslaget på ansøgningen om ændringen.
English: Γ.Α.Σταμάτης & Σια Λτδ.
Danish: Κύπρος Γ.Α.Σταμάτης & Σια Λτδ.
English: These measures will help to protect the environment.
Danish: Disse tiltag medvirker til at beskytte miljøet.
English: • Risk Management Plan (RMP)
Danish: · Risikostyringsplan (RMP)
English: • Your doctor will monitor you carefully during the first infusion.
Danish: · Lægen vil holde godt øje med dig under den første infusion.
English: Before your treatment, your doctor will check your general health.
Danish: Inden du starter behandling vil lægen kontrollere dit generelle helbred.
English: Details on how to minimise the safety concerns through appropriate monitoring and management.
Danish: Detaljer om minimering af sikkerhedsmæssige aspekter med passende overvågning og håndtering.
English: They may happen weeks or months after your last dose.
Danish: De kan opstå uger eller måneder efter din sidste dosis.
English: This medicine should not be given to children or adolescents below 18 years of age.
Danish: Dette lægemiddel må ikke gives til børn eller unge under 18 år.
English: If you feel tired, do not drive or use machines until you feel better.
Danish: Hvis du føler dig træt, bør du ikke føre motorkøretøj eller bruge maskiner, før du har det bedre.
English: The use of in-line filter membranes is optional.
Danish: Brug af in-line filtermembraner er valgfri.
English: Your doctor will keep giving you Tecentriq until you no longer benefit from it.
Danish: Lægen vil blive ved med at give dig Tecentriq indtil du ikke længere har gavn af det.
English: Submission of study results: 31 December
Danish: Indsendelse af studieresultater: 31. december
English: Do not try to treat yourself with other medicines.
Danish: Du skal ikke behandle dig selv med anden medicin.
English: For the treatment to be fully effective, it is very important to keep having the infusions.
Danish: For at behandlingen kan være så effektiv som muligt, er det meget vigtigt at blive ved med at få infusionerne.
English: Patients were staged according to the American Joint Committee on Cancer (AJCC) 7th edition.
Danish: Patienterne blev stadieinddelt ifølge American Joint Committee on Cancer (AJCC) 7. udgave.
English: Overall, ADA status appeared to have no clinically relevant impact on safety.
Danish: Overordnet syntes ADA-status ikke at have klinisk relevant betydning for sikkerheden.
English: Tests and checks
Danish: Test og kontroller
English: The time to onset was 18 and 33 days.
Danish: Tiden til hændelsen var 18 og 33 dage.
English: Reported in studies outside the pooled dataset.
Danish: Rapporteret i andre studier uden for det samlet datasæt.
English: ATC code: L01XC32
Danish: ATC-kode: L01XC32
English: Median in months ***
Danish: Median i måneder***
English: Median in months
Danish: Median i måneder
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Danish: For at forbedre sporbarheden af biologiske lægemidler, bør handelsnavn og batchnummer for det administrerede produkt altid registreres tydeligt i patientjournalen.
English: • Additional risk minimisation measures
Danish: · Yderligere risikominimeringsforanstaltninger
English: The frequency is based on the program wide exposure.
Danish: Hyppigheden er baseret på programmets brede eksponering q
English: The median age was 73 years.
Danish: Medianalder var 73 år.
English: Aseptic preparation, handling and storage
Danish: Aseptisk klargøring, håndtering og opbevaring
English: The stratified log-rank p-value was 0.41 and therefore the results are considered not statistically significant in this population.
Danish: Den stratificerede log-rank p-værdi var 0,41, og resultaterne kan derfor ikke betragtes som statistisk signifikante i denne population.
English: If a planned dose of Tecentriq is missed, it should be administered as soon as possible.
Danish: Hvis en planlagt dosis af Tecentriq ikke er givet, skal denne administreres så hurtigt som muligt.
English: The study enrolled a total of 438 patients and had two patient cohorts.
Danish: Studiet omfattede i alt 438 patienter og bestod af 2 patientkohorter.
English: Immune-related adverse reactions affecting more than one body system have been observed.
Danish: Der er set immunrelaterede bivirkninger, der påvirkede mere end ét kropssystem.