FrancophonIA/ELRC3.0 huggingface dataset:
English: During their September 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Glucomed and associated names for the relief of symptoms in mild to moderate osteoarthritis of the knee, that there was no objection for the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State
Danish: På sit møde i september 2006 var CHMP på grundlag af de samlede forelagte oplysninger og de faglige drøftelser i udvalget af den opfattelse, at risk/benefit-forholdet var gunstigt for Glucomed og tilknyttede navne til symptomlindring ved mild til moderat slidgigt i knæet, og der ikke var
English: This summary was last updated in: 04-2013.
Danish: Dette sammendrag blev sidst ajourført den 04-2013.
English: Immunity starts after three weeks and lasts for three months.
Danish: Immuniteten opnås efter tre uger og varer i tre måneder.
English: If pain persists for more than 12 hours after examination, seek medical advice again.
Danish: Hvis smerterne varer ved i mere end 12 timer efter undersøgelsen, skal der igen søges lægehjælp.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CVMP's anbefalinger, kan du læse de faglige drøftelser (også en del af denne EPAR).
English: This can be up to 2 cm in diameter after first injection and up to 5 cm after the second, but they usually disappear within three weeks.
Danish: Den kan være op til 2 cm i diameter efter den første injektion og op til 5 cm i diameter efter den anden injektion, men reaktionerne forsvinder normalt inden for tre uger.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a diseases.
Danish: Vacciner fungerer ved at 'lære' immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare sig mod sygdomme.
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Danish: Fremover vil immunsystemet være i stand til at danne antistoffer hurtigere, når det igen udsættes for disse vira.
English: Accidental injection can cause severe pain and swelling, particularly if the vaccine is injected into a joint or finger.
Danish: Uforsætlig injektion kan forårsage voldsomme smerter og hævelser, især hvis vaccinen injiceres i et led eller en finger.
English: Wash and disinfect hands and equipment after use.
Danish: Hænder og udstyr skal vaskes og desinficeres efter brug af vaccinen.
English: This protects the pigs against the disease.
Danish: Dette beskytter grisene mod sygdommen.
English: In up to a half of pigs being vaccinated, a slight temporary reaction can occur at the site of injection.
Danish: Hos op til halvdelen af de grise, som vaccineres, kan der forekomme en mindre, forbigående reaktion på injektionsstedet.
English: Female breeding pigs should be revaccinated before their first mating or during each pregnancy, three to six weeks before giving birth.
Danish: Avlssøer skal revaccineres før deres første parring eller under hver drægtighedsperiode tre til seks uger før faringen.
English: The vaccine also contains ‘adjuvants' (a compound containing aluminium as well as mineral oil, an emulsifier and a detergent) to stimulate a better response.
Danish: Vaccinen indeholder også 'adjuvanser' (et aluminiumholdigt stof, mineralolie, en emulgator og en detergent), der har til formål at stimulere en bedre respons.
English: It prevents death and symptoms of the disease and reduces the shedding of the virus.
Danish: Vaccinen forebygger dødsfald og symptomer som følge af sygdommen og reducerer spredning af virusset.
English: An increase in body temperature up to about 40.5°C can occur in a small number of pigs, lasting for up to two days.
Danish: Der kan hos et mindre antal grise forekomme en stigning i kropstemperaturen til op til ca. 40,5° C, som varer i op til to dage.
English: Breeding boars (male pigs) should be revaccinated every six months.
Danish: Avlsorner (hangrise) skal revaccineres hver sjette måned.
English: The virus has been genetically modified: it has had one of its gene deleted (the gene that makes it able to produce an enzyme called thymidine kinase) and this is what makes it weaker.
Danish: Virusset er blevet genmodificeret ved, at et af dets gener er fjernet (det gen, som gør virusset i stand til at danne enzymet thymidinkinase), hvilket gør det svagere.
English: The antibodies are also passed on from mother to piglet through the colostrums (first milk) and milk.
Danish: Antistofferne overføres også fra soen til smågrisen gennem colostrum (den første mælk i dieperioden) og modermælken.
English: After vaccination, the number of pig herds with signs of infection fell significantly, as did the number of infected pigs within the herds.
Danish: Efter vaccinationen faldt antallet af grisebesætninger med tegn på infektion væsentligt, og det samme gjorde antallet af inficerede grise i besætningerne.
English: Live attenuated Aujeszky's Disease Virus
Danish: Levende, fortyndet Aujeszkys sygdomsvirus
English: The herds of pigs were monitored for signs of infection with the type of Aujeszky's disease virus that is can be caught in the field.
Danish: Grisebesætningerne blev overvåget i forbindelse med tegn på infektion med den type af Aujeszkys sygdomsvirus, som kan pådrages i marken.
English: There was no change in the infection rates in the pigs that were not vaccinated.
Danish: Der var ingen ændring i antallet af infektioner blandt grise, som ikke blev vaccineret.
English: In case of accidental injection, seek prompt medical advice and show the Package Leaflet to the doctor.
Danish: I tilfælde af uforsætlig injektion skal der omgående søges lægehjælp, og indlægssedlen skal vises til lægen.
English: To vaccinate a whole herd, one dose should be given to every male and female breeding pig every four months.
Danish: Hvis en hel besætning skal vaccineres, skal alle avlsorner og -søer have én dosis hver fjerde måned.
English: The studies compared the levels of infection in vaccinated and unvaccinated pigs.
Danish: I undersøgelserne blev graderne af infektion hos vaccinerede og ikke-vaccinerede grise sammenlignet.
English: When a pig is given the vaccine, the immune system recognises the weakened viruses as ‘foreign' and makes antibodies against them.
Danish: Når en gris får vaccinen, opfatter immunsystemet de svækkede vira som fremmedlegemer og danner antistoffer mod dem.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Danish: Benefit/risk-forholdet findes i afsnit 6 i denne EPAR.
English: Vaccination of gilts (female pigs that have not yet had piglets) and sows (female pigs that have had piglets before) with Suvaxyn Aujeszky 783 + O/W can also result in immunity in the pig's offspring.
Danish: Vaccination af gylter (hungrise, der endnu ikke har fået smågrise) og søer (hungrise, der har fået smågrise) med Suvaxyn Aujeszky 783 + O/W kan også give immunitet hos grisens afkom.
English: The effectiveness of Suvaxyn Aujeszky 783 + O/W has been studied in a large number of pigs in several farms in studies lasting around two years.
Danish: Effekten af Suvaxyn Aujeszky 783 + O/W blev undersøgt hos et stort antal grise på flere gårde i undersøgelser, som varede ca. to år.
English: What is the withdrawal period?
Danish: Tilbageholdelsestiden er nul dage.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn Aujeszky 783 + O/W on 7 August 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Suvaxyn Aujeszky 783 + O/W den 7. august 1998.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Danish: Hvor lang tid skal der gå, før dyret kan slagtes, og kødet kan anvendes til menneskeligt forbrug (tilbageholdelsestid)?
English: Suvaxyn Aujeszky 783 + O/W is a powder and solvent that are made up into an emulsion (a mixture of oil- and water-based liquids) for injection.
Danish: Suvaxyn Aujeszky 783 + O/W er et pulver og en solvens, som blandes til en emulsion (en blanding af olie- og vandbaserede væsker) til injektion.
English: Suvaxyn Aujeszky 783 + O/W was effective at preventing infection with the virus.
Danish: Suvaxyn Aujeszky 783 + O/W var effektiv til forebyggelse af infektion med virusset.
English: Suvaxyn Aujeszky 783 + O/W is given as two 2 ml injections into the muscle of the neck behind the ear, three to four weeks apart.
Danish: Suvaxyn Aujeszky 783 + O/W gives som to 2 ml-injektioner i nakkemusklen bag øret med tre til fire ugers mellemrum.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Suvaxyn Aujeszky 783 + O/W exceed the risks for the treatment of active immunisation of pigs from the age of 10 weeks to prevent the mortality and clinical signs of Aujeszky's Disease and to reduce the excretion of Aujeszky's Disease field virus.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Suvaxyn Aujeszky 783 + O/W er større end risiciene, når lægemidlet anvendes til aktiv og passiv immunisering af grise for at forebygge eller reducere mortalitet i forbindelse med Aujeszkys sygdom og de kliniske tegn på sygdommen samt for at reducere udskillelsen af Aujeszkys sygdomsmarkvirus.
English: This enables the piglets of vaccinated pigs to be protected against the disease.
Danish: Dette beskytter smågrise fra vaccinerede søer mod sygdommen.
English: Suvaxyn Aujeszky 783 + O/W is used to vaccinate pigs from the age of 10 weeks against Aujeszky's disease, an illness similar to rabies that is caused by a herpesvirus.
Danish: Suvaxyn Aujeszky 783 + O/W anvendes til vaccination af grise fra 10-ugersalderen mod Aujeszkys sygdom, som er en sygdom, der minder om rabies, og som forårsages af et herpesvirus.
English: Suvaxyn Aujeszky 783 + O/W is a vaccine that contains a live attenuated (weakened) form of Aujeszky's disease virus strain NIA3-783.
Danish: Suvaxyn Aujeszky 783 + O/W er en vaccine, der indeholder en levende, svækket (fortyndet) form for Aujeszkys sygdom, virusstamme NIA3-783.
English: Suvaxyn Aujeszky 783 + O/W is a vaccine.
Danish: Suvaxyn Aujeszky 783 + O/W er en vaccine.
English: Other information about Suvaxyn Aujeszky 783 + O/W:
Danish: Andre oplysninger om Suvaxyn Aujeszky 783 + O/W:
English: What is the risk associated with Suvaxyn Aujeszky 783 + O/W?
Danish: Hvilken risiko er der forbundet med Suvaxyn Aujeszky 783 + O/W?
English: Why has Suvaxyn Aujeszky 783 + O/W been approved?
Danish: Hvorfor blev Suvaxyn Aujeszky 783 + O/W godkendt?
English: Suvaxyn Aujeszky 783 + O/W contains small amounts of a weakened form of the virus that causes Aujeszky's disease.
Danish: O/W indeholder små mængder af en svækket form af det virus, der forårsager Aujeszkys sygdom.
English: What is Suvaxyn Aujeszky 783 + O/W?
Danish: Hvad er Suvaxyn Aujeszky 783 + O/W?
English: How has Suvaxyn Aujeszky 783 + O/W been studied?
Danish: Hvordan blev Suvaxyn Aujeszky 783 + O/W undersøgt?
English: How does Suvaxyn Aujeszky 783 + O/W work?
Danish: Hvordan virker Suvaxyn Aujeszky 783 + O/W?
English: What benefit has Suvaxyn Aujeszky 783 + O/W shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Suvaxyn Aujeszky 783 + O/W?
English: Pregabalin Sandoz GmbH is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Danish: Pregabalin Sandoz GmbH fås som kapsler (25, 50, 75, 100, 150, 200, 225 og 300 mg) og udleveres kun efter recept.
English: Stopping treatment with Pregabalin Sandoz GmbH should also be done gradually, over at least a week.
Danish: Ved ophør af behandlingen med Pregabalin Sandoz GmbH bør dette ligeledes ske gradvis, i løbet af mindst en uge.
English: The full EPAR and risk management plan summary for Pregabalin Sandoz GmbH can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Pregabalin Sandoz GmbH findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Sandoz GmbH on 19 June 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pregabalin Sandoz GmbH den 19. juni 2015.
English: (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Danish: • som tillægsbehandling ved epilepsi med partielle epileptiske anfald (anfald, der begynder i en bestemt del af hjernen), når anfaldene ikke kan kontrolleres med patientens nuværende behandling,
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Sandoz GmbH.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pregabalin Sandoz GmbH.
English: A risk management plan has been developed to ensure that Pregabalin Sandoz GmbH is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pregabalin Sandoz GmbH anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Sandoz GmbH has been shown to have comparable quality and to be bioequivalent to Lyrica.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pregabalin Sandoz GmbH er af sammenlignelig kvalitet og er bioækvivalent med Lyrica.
English: This means that Pregabalin Sandoz GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Danish: Det betyder, at Pregabalin Sandoz GmbH er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Lyrica.
English: The Committee recommended that Pregabalin Sandoz GmbH be approved for use in the EU.
Danish: Udvalget anbefalede, at Pregabalin Sandoz GmbH godkendes til anvendelse i EU.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Sandoz GmbH, 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 Pregabalin Sandoz GmbH, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The active substance in Pregabalin Sandoz GmbH, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Danish: Det aktive stof i Pregabalin Sandoz GmbH, pregabalin, minder i struktur om kroppens eget signalstof GABA (neurotransmitteren gamma-aminosmørsyre), men dets biologiske virkninger er meget anderledes.
English: Pregabalin Sandoz GmbH is a medicine used to treat adults with the following conditions:
Danish: Pregabalin Sandoz GmbH er et lægemiddel til behandling af voksne med følgende tilstande:
English: For practical information about using Pregabalin Sandoz GmbH, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pregabalin Sandoz GmbH, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Because Pregabalin Sandoz GmbH is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pregabalin Sandoz GmbH er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Pregabalin Sandoz GmbH contains the active substance pregabalin.
Danish: Pregabalin Sandoz GmbH indeholder det aktive stof pregabalin.
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in epilepsy and anxiety.
Danish: Derved mindskes frigivelsen af andre neurotransmittere, der er en medvirkende årsag til smerter, epilepsi og angst.
English: What measures are being taken to ensure the safe and effective use of Pregabalin Sandoz GmbH?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pregabalin Sandoz GmbH?
English: It is not intended to provide practical advice on how to use Pregabalin Sandoz GmbH.
Danish: Det er ikke en praktisk vejledning i, hvordan Pregabalin Sandoz GmbH bør anvendes.
English: Pregabalin Sandoz GmbH is a ‘generic medicine'.
Danish: Pregabalin Sandoz GmbH er et "generisk lægemiddel".
English: What are the benefits and risks of Pregabalin Sandoz GmbH?
Danish: Hvilke fordele og risici er der forbundet med Pregabalin Sandoz GmbH?
English: Other information about Pregabalin Sandoz GmbH
Danish: Andre oplysninger om Pregabalin Sandoz GmbH
English: What is Pregabalin Sandoz GmbH and what is it used for?
Danish: Hvad er Pregabalin Sandoz GmbH, og hvad anvendes det til?
English: For more information about treatment with Pregabalin Sandoz GmbH, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: GmbH, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why is Pregabalin Sandoz GmbH approved?
Danish: Hvorfor blev Pregabalin Sandoz GmbH godkendt?
English: How has Pregabalin Sandoz GmbH been studied?
Danish: Hvordan blev Pregabalin Sandoz GmbH undersøgt?
English: How is Pregabalin Sandoz GmbH used?
Danish: Hvordan anvendes Pregabalin Sandoz GmbH?
English: How does Pregabalin Sandoz GmbH work?
Danish: Hvordan virker Pregabalin Sandoz GmbH?
English: Because Pregabalin Sandoz GmbH is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Danish: Patientundersøgelserne har derfor været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Lyrica.
English: Each carton contains:
Danish: Hver æske indeholder:
English: Results on these end-points were supportive of the primary end-points results.
Danish: Resultater på disse endepunkter understøttede de primære endepunkt-resultater.
English: • 18 months.
Danish: 18 måneder.
English: 2003 RN Haarlem The Netherlands
Danish: 2003 RN Haarlem Nederlandene
English: Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Danish: Din læge vil diskutere disse med dig og forklare mulige fordele og risici ved behandlingen.
English: In some cases concomitant factors may have contributed to the development of these effects.
Danish: I nogle tilfælde kan samtidige risikofaktorer muligvis have medvirket til udviklingen af disse virkninger.
English: The infusion will last approximately one hour during which you will be in the hospital.
Danish: Infusionen tager ca. en time, mens du er på hospitalet.
English: • raised liver enzymes (hence the need for regular blood tests).
Danish: Forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver).
English: Such information will allow her/him to decide whether a dose reduction is needed.
Danish: Denne information vil give lægen mulighed for at vurdere, om en nedsættelse af dosis er nødvendig.
English: Statistical Analysis
Danish: Statistisk analyse
English: Concentrate Polysorbate 80
Danish: Koncentrat Polysorbat 80
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided fro under Article 107c(7) of Directive 2001/83/EC and published on the European Medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Older people treated with TCF should be closely monitored.
Danish: Ældre personer, som behandles med TCF, bør monitoreres nøje.
English: 2100 Gödöllő
Danish: 2100 Gödöllő Ungarn
English: A total of 1006 patients with KPS≥60 were randomized to the following treatment groups:
Danish: I alt 1.006 patienter med KPS ≥ 60 blev randomiseret i følgende behandlingsgrupper:
English: Median time to progression (weeks)
Danish: Gennemsnitlig tid til progression (uger)
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Reconstituted solution must be further diluted in the infusion diluent before administration.
Danish: Rekonstitueret opløsning skal fortyndes yderligere i opløsningsvæsken til infusion inden administration.
English: Overall survival (Primary end-point):
Danish: Total overlevelse (Primær endepunkt)
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppigheder defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); frekvens ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored.
Danish: I tilfælde af en overdosis skal patienten indlægges på en specialafdeling, og de vitale funktioner skal følges nøje.
English: Risk Management Plan (RMP) Not applicable.
Danish: Risikostyringsplan (RMP)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -betingelser før brug brugerens ansvar og vil normalt ikke overskride 24 timer ved 2 °C til 8 °C, medmindre fortynding har fundet sted under kontrollerede og godkendte aseptiske forhold.
English: Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin.
Danish: Begrænsede data fra et enkelt, ukontrolleret studium antydede en interaktion mellem docetaxel og carboplatin.
English: • fever: if this happens you must tell your doctor immediately
Danish: Feber: Hvis dette forekommer, skal du straks fortælle det til din læge
English: Overall response rate (%):
Danish: Total responsrate (%):
English: For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Danish: For docetaxel/Carboplatin-kombinationen kunne der hverken bevises ækvivalent eller non-inferior effekt sammenlignet med referencebehandlingskombinationens VCis.
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
Danish: Farmakoterapeutisk klassifikation: Taxaner, ATC-kode: L01CD 02
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Cases of persisting alopecia have been reported.
Danish: Tilfælde af vedvarende alopeci er rapporteret.