FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: Hypokalaemia, diabetes mellitus, anorexia, increased or decreased appetite, hypoalbuminaemia, fluid retention, hyperuricaemia;
Danish: Meget almindelige: Hyperglykæmi Almindelige: Hypokaliæmi, diabetes mellitus, anoreksi, øget eller nedsat appetit, hypoalbuminæmi, væskeretention, hyperurikæmi Ikke almindelige: Dehydrering, hypokalcæmi, hypomagnesiæmi Ikke kendt: Nedsat glukosetolerance, natriumretention, metabolisk alkalose
English: The combination of lenalidomide with dexamethasone in relapsed or refractory multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients).
Danish: Kombination af lenalidomid med dexamethason ved recidiverende eller refraktært multipelt myelom er forbundet med højere forekomst af neutropeni af grad 3 og trombocytopeni af grad 4 (hhv. 9,9 % og 1,4 % hos patienter behandlet med lenalidomid/dexamethason, sammenholdt med 2,3 % og 0,0 % hos patienter behandlet med placebo/dexamethason).
English: The combination of dexamethasone with lenalidomide in multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients; see section 4.8).
Danish: Kombination af dexamethason med lenalidomid hos patienter med multipelt myelom er forbundet med højere forekomst af neutropeni af grad 4 (5,1 % hos patienter behandlet med lenalidomid/dexamethason, sammenholdt med 0,6 % hos patienter behandlet med placebo/dexamethason; se pkt.
English: The combination of lenalidomide with dexamethasone in relapsed or refractory multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients).
Danish: Hos patienter med recidiverende eller refraktært multipelt myelom er kombination af lenalidomid med dexamethason forbundet med øget forekomst af neutropeni af grad 4 (5,1 % hos patienter behandlet med lenalidomid/dexamethason, sammenholdt med 0,6 % hos patienter behandlet med placebo/dexamethason).
English: The combination of dexamethasone with lenalidomide in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients) (see section 4.8).
Danish: Kombination af dexamethason med lenalidomid ved multipelt myelom er forbundet med højere forekomst af neutropeni af grad 3 og trombocytopeni af grad 4 (hhv. 9,9 % og 1,4 % hos patienter behandlet med lenalidomid/dexamethason, sammenholdt med 2,3 % og 0,0 % hos patienter behandlet med placebo/dexamethason) (se pkt.
English: Common: Pain, mucosal inflammation, pyrexia, chills, malaise; Not known: Impaired healing.
Danish: Almindelige: Smerter, slimhindeirritation, pyreksi, kulderystelser, utilpashed
English: − Rash, itching, reddened skin;
Danish: − hududslæt, kløe, rød hud
English: Effects of dexamethasone on other medicinal products Dexamethasone is a moderate inducer of CYP3A4 and of P-gp.
Danish: Dexamethason inducerer CYP3A4 og P-gp i moderat grad.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet,
English: (purpura);
Danish: − nyresvigt.
English: Tumour lysis syndrome
Danish: inflammation af slimhinderne
English: Not known: Convulsions.
Danish: Ikke kendt: Nedsat helingsevne
English: − Cataract, blurred vision;
Danish: − grøn stær, sløret syn
English: The combination of dexamethasone with thalidomide, lenalidomide or pomalidomide (medicines to treat multiple myeloma) increases the risk of blood clots in the veins and arteries.
Danish: Risikoen for blodpropper i vener og arterier øges, når dexamethason anvendes sammen med thalidomid, lenalidomid eller pomalidomid (lægemidler til behandling af multipelt myelom).
English: Cardiac disorders
Danish: Tumorlysesyndrom
English: There is no reason to believe that other efficacy parameters would be influenced any differently in the field.
Danish: Der er ingen grund til at antage, at andre virkningsparametre ville blive påvirket anderledes på dette område.
English: Thus, the overall the benefit/risk balance is considered to be positive.
Danish: Det overordnede benefit/risk-forhold anses således for at være positivt.
English: 3) The minimum efficacious titre is 4.0 TCID50
Danish: 3) Den minimale effektive titer er 4,0 TCID50
English: Following the absence of agreement between the Reference Member State (the United Kingdom) and one of the Concerned Member States (Spain) at day 90 of the CMDv procedure, the matter was referred to the CVMP on 2 October 2009.
Danish: Eftersom der ikke blev opnået enighed mellem referencemedlemsstaten (Det Forenede Kongerige) og en af de berørte medlemsstater (Spanien) på dag 90 i CMDv-proceduren, blev sagen indbragt for CVMP den 2. oktober 2009.
English: The safety of the regimen for the both individual and mixed vaccines has been supported.
Danish: Regimenets sikkerhed for både individuelle og blandede vacciner er blevet dokumenteret.
English: There are both practical reasons as well as clinical advantages to administering these 2 products together which leads to an overall improvement in animal welfare.
Danish: Der er både praktiske grunde og kliniske fordele forbundet med at indgive disse 2 lægemidler sammen, som giver en overordnet forbedring af dyrevelfærden.
English: List of the names, pharmaceutical form, strength of the Veterinary medicinal products, animal species, routes of administration, withdrawal period, marketing authorisation holders in the Member states
Danish: LISTE OVER DET VETERINÆRLÆGEMIDLETS NAVNE, LÆGEMIDDELFORMER, STYRKER, DYREARTER, ADMINISTRATIONSVEJ, TILBAGEHOLDELSESTID, INDEHAVER AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSSTATERNE
English: 2) The apparent drop over 1 hour from the titre at release (6.4/6.2 TCID50) is 0.12/
Danish: 2) Det umiddelbare fald over 1 time i titeren ved frigivelse (6,4/6,2 TCID50) er 0,12/
English: Given that a lack of interference has been demonstrated at a specific time point the duration of immunity remains the same as originally proven.
Danish: Eftersom den manglende interferens er blevet påvist på et specifikt tidspunkt, er immunitetsvarigheden den samme som det oprindeligt påviste.
English: Intramuscular injection: 2 ml in the neck.
Danish: Intramuskulær injektion: 2 ml i nakken.
English: It should be noted that the general claim to reduce viraemia has only been demonstrated in laboratory studies.
Danish: Det skal bemærkes, at den generelle påstand om en reduktion af viræmi er kun blevet påvist i laboratorieundersøgelser.
English: It should be noted that local and systemic reactions were unremarkable (mild and seen in a small proportion of animals) and consistent with those seen when vaccines were used alone.
Danish: Det skal understreges, at de lokale og systemiske reaktioner ikke var signifikante (de var milde og forekom hos en lille andel af dyrene), og at de var i overensstemmelse med dem, der forekom, når vaccinerne blev anvendt alene.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PORCILIS PRRS (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN VIDENSKABELIGE VURDERING AF PORCILIS PRRS (SE BILAG I)
English: To maintain a high and homologous level of immunity, revaccination at regular intervals is recommended, either before each next gestation or at random at 4 month intervals.
Danish: For at opretholde et højt og ensartet niveau af immunitet anbefales det at revaccinere med faste intervaller, enten før næste drægtighed eller hver 4 måned.
English: Freeze-dried vaccine:
Danish: Frysetørret vaccine:
English: 2.3 Potential impact on the efficacy parameter of duration of immunity due to an interference caused by mixing of the two products.
Danish: 2.3 Potentiel indvirkning på virkningsparameteret immunitetsvarighed som følge af en interferens, der skyldes blandingen af de to lægemidler.
English: It should be borne in mind that PRRS is a multifactorial disease and therefore all clinical signs may not always be seen in laboratory studies (animals kept free from other agents) as in field studies.
Danish: Man skal huske, at PRRS er en multifaktoriel sygdom, og derfor er alle kliniske tegn ikke altid tydelige ved laboratorieundersøgelser (dyrene holdes fri for andre stoffer) og i feltundersøgelser.
English: Animal species
Danish: Dyrearter
English: Volume (ml) of diluent needed for
Danish: Mængde (ml) solvens nødvendig for
English: Intradermal application: 0.2 ml on top or to the left or right side of the neck, or along the muscles of the back, using an intradermal device.
Danish: Intradermal indgift: 0,2 ml ovenpå eller på venstre eller højre side af halsen, eller langs med rygmuskulaturen, ved brug af udstyr til intradermal indgift.
English: The serological response to PRRS vaccination was also found similar in both groups of pigs.
Danish: Den serologiske respons på PRRS-vaccination var også den samme for begge grupper af svin.
English: The in-use stability of the mixed vaccines has been adequately demonstrated over an in-use period of an hour which is sufficient to vaccinate the number of animals representative of a realistic scenario.
Danish: De blandede vacciners stabilitet ved brug er blevet tilstrækkeligt påvist under en brugstid på en time, som er tilstrækkelig til at vaccinere et antal dyr, der repræsenterer et realistisk scenario.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Danish: En eventuel beslutning om at anvende vaccinen umiddelbart før eller efter brug af et andet lægemiddel til dyr skal derfor tages med udgangspunkt i det enkelte tilfælde.
English: 1) The claimed in-use shelf life for the “mixed” product is one hour;
Danish: 1) Den angivne holdbarhed ved brug for det "blandede" lægemiddel er 1 time
English: Finishing pigs: a single vaccination is sufficient for protection until slaughter.
Danish: Slagtesvin: En enkelt vaccination giver tilstrækkelig beskyttelse frem til slagtning.
English: In both of them, there was no gain in the average daily weight of the vaccinated animals, even when there were indications that PRRS infection had occurred.
Danish: I begge af disse sås ingen stigning i den daglige gennemsnitsvægtforøgelse hos de vaccinerede dyr, heller ikke, når der var tegn på PRRS-infektion.
English: The solvent includes dl--tocopherol acetate as adjuvant.
Danish: Solvensen indeholder dl--tocopherolacetat som adjuvans.
English: Member State/EEA
Danish: Medlemstat /EU
English: 4) this means that in the worst case scenario of a batch at the end of shelf being mixed there will be no statistically significant drop below the minimum titre over the claimed in-use shelf life of 1 hour.
Danish: 4) Det betyder, at der i det værst tænkelige scenario, hvor man blander et batch, hvis holdbarhed er ved at være udløbet, ikke vil være noget statistisk signifikant fald under minimumstiter i den angivne holdbarhed ved brug på 1 time.
English: Porcilis PRRS is an immunological veterinary medicinal product containing the Porcine Reproductive and Respiratory Syndrome (PRRS) virus.
Danish: Porcilis PRRS er et immunologisk veterinærlægemiddel, der indeholder porcint reproduktivt og respiratorisk syndrom (PRRS)-virus.
English: Number of doses per vial intramuscular injection intradermal application
Danish: Antal doser pr. hætteglas intramuskulær injektion intradermal administration
English: The marketing authorisation holder considers that the reduction of clinical signs is the direct effect of reduction of viraemia.
Danish: Indehaveren af markedsføringstilladelsen er af den opfattelse, at reduktionen af de kliniske tegn er en direkte følge af reduktionen af viræmi.
English: Vaccination scheme: A single dose is given to pigs from 2 weeks of age onwards.
Danish: Vaccinationsprogram: En enkelt dosis gives til grise fra 2 ugers alderen.
English: For breeding pigs…”
Danish: Hos avlssvin…”
English: The live vaccine is composed of a lyophilised fraction, which includes the antigen, and a solvent for suspension for injection.
Danish: Den levende vaccine består af en lysophiliseret fraktion, som indeholder antigenet, og en solvens til injektionsvæske, suspension.
English: Use sterile syringes and needles or clean intradermal equipment.
Danish: Anvend sterile sprøjter og kanyler eller rent intradermalt udstyr.
English: The guideline on data requirements to support in-use stability claims for veterinary vaccines1, states that “For inactivated vaccines, if the proposed in-use shelf-life is within one working day (maximum 10 hours) it is acceptable to omit the potency testing from the in-use shelf-life stability study.”
Danish: I retningslinjerne for krav til data til støtte for veterinære vacciners stabilitet ved brug (Guideline on data requirements to support in-use stability claims for veterinary vaccines)1 står der, at "for inaktiverede vacciner er det, hvis den foreslåede holdbarhed ved brug er højst én arbejdsdag (maksimalt 10 timer), acceptabelt at udelade styrketesten fra undersøgelsen af stabilitet under holdbarhed ved brug."
English: The marketing authorisation holder Intervet International BV submitted a Type II variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the veterinary medicinal product Porcilis PRRS in the framework of Article 6 of Commission Regulation (EC) No 1084/2003.
Danish: Indehaveren af markedsføringstilladelsen, Intervet International BV, indsendte en ansøgning om en type II-ændring af markedsføringstilladelserne for veterinærlægemidlet Porcilis PRRS i henhold til proceduren for gensidig anerkendelse inden for rammerne af artikel 6 i Kommissionens forordning (EF) nr. 1084/2003.
English: The CVMP therefore considers that the efficacy of the mixed vaccine regarding the PRRS component has been sufficiently supported.
Danish: CVMP var derfor af den opfattelse, at den blandede vaccines virkning med hensyn til PRRS-komponenten var tilstrækkeligt underbygget.
English: These can be regarded as demonstrating equivalence of immune response and it would not be expected that if the immune response is not altered at one point in time that the duration of that response will be any different.
Danish: Disse undersøgelser kan anses for at påvise en ækvivalent immunrespons, og det forventes ikke, at varigheden af immunresponsen bliver anderledes, hvis immunresponsen ikke ændres på et tidspunkt.
English: In order to ascertain that there is no significant decrease in the titre right after mixing (i.e., at t=0), it was considered important to know the titre at release (or after reconstitution in the diluent fraction of Porcilis PRRS).
Danish: For at fastslå, at der ikke er noget signifikant fald i titer lige efter blanding (dvs. ved t=0), blev det anset for vigtigt at kende titer ved frigivelse (eller efter rekonstituering i fortyndingsfraktionen af Porcilis PRRS).
English: The amendments of the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III.
Danish: Ændringerne af de relevante punkter i produktresuméet og indlægssedlen fremgår af bilag III.
English: Pregnant sows should only be vaccinated after previous exposure to European PRRS virus.
Danish: Drægtige søer bør kun vaccineres, hvis de tidligere har været eksponerede overfor europæisk PRRS-virus.
English: However, it was considered that all the claims to appear in the SPC should be demonstrated.
Danish: Man var dog af den opfattelse, at alle påstande, som skulle fremgå af produktresuméet, skulle være påvist.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Danish: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nederland
English: Intervet Deutschland GmbH
Danish: Tyskland Intervet Deutschland GmbH
English: The specific claims for finishing pigs to improve the rearing results have not been demonstrated.
Danish: De specifikke påstande om, at slagtesvins opdrætsresultater forbedres, er ikke blevet påvist.
English: Duration of immunity of Porcilis PRRS has also not been demonstrated for simultaneous administration.
Danish: Immunitetsvarigheden for Porcilis PRRS er heller ikke blevet påvist, når det gælder samtidig indgivelse.
English: In addition, it was not known whether the studies were performed with batches of vaccines approaching the end of their shelf life.
Danish: Desuden var det uvist, om undersøgelserne blev foretaget med batcher af vacciner, hvor holdbarheden var ved at være udløbet.
English: Product name
Danish: Lægemidlets navn
English: 0.02 (mean 0.05) which is within assay variability;
Danish: 0,02 (gennemsnit 0,05), hvilket ligger inden for analyseafvigeligheden
English: - the CVMP considered that stability of the mixed product up to 1 hour after mixing as claimed on the Summary of Product Characteristics was supported by the data provided, - the CVMP considered that the efficacy of the mixed vaccine regarding the PRRS component was sufficiently supported by the data provided, the CVMP has recommended the granting of the variation of the Marketing Authorisations for Porcilis PRRS and associated names (see Annex I).
Danish: - CVMP var af den opfattelse, at stabiliteten af det blandede lægemiddel i op til 1 time efter blanding, som angivet i produktresuméet, blev underbygget af de fremlagte data, - CVMP var af den opfattelse, at den blandede vaccines virkning med hensyn til PRRSkomponenten var tilstrækkeligt underbygget af de fremlagte data, anbefalede CVMP godkendelse af ændringen af markedsføringstilladelserne for Porcilis PRRS og tilknyttede navne (se bilag I).
English: Specific claims For finishing pigs, the effect of the virus on the respiratory system is most relevant.
Danish: Hos slagtesvin er virussens virkning på åndedrætssystemet den mest relevante.
English: Scientific conclusions and grounds for the granting of the variation of the marketing authorisations
Danish: FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR GODKENDELSE AF ÆNDRINGEN AF MARKEDSFØRINGSTILLADELSERNE
English: 4.9 Amounts to be administered and administration route Reconstitute the vaccine with the corresponding adjuvating diluent (use only Diluvac Forte).
Danish: 4.9 Dosering og indgivelsesmåde Rekonstituer vaccinen med tilhørende solvens (anvend kun ”Diluvac Forte”).
English: Nevertheless, absence of immunological interference has not been inferred but has been clearly demonstrated by providing laboratory challenge data which showed that there is no significant difference in protection between animals vaccinated with the mixed products and those vaccinated with single products.
Danish: Det er ikke blevet konkluderet, at der ikke er immunologisk interferens, men det er tydeligt påvist ved hjælp af laboratoriechallengedata, som viste, at der ikke er nogen signifikant forskel i beskyttelsen af dyr, der er vaccineret med det blandede lægemiddel, og dyr, der er vaccineret med de enkelte lægemidler.
English: Reduction of viraemia was shown in two laboratory efficacy studies and this was considered sufficient by the marketing authorisation holder for the assessment of the clinical efficacy.
Danish: Denne reduktion blev påvist i to laboratorievirkningsundersøgelser, hvilket indehaveren af markedsføringstilladelsen anså for tilstrækkeligt til at vurdere den kliniske virkning.
English: A small, transient, intradermal lump observed after the intradermal application is indicative of the appropriate vaccination technique.
Danish: En lille, forbigående, intradermal hævelse på injektionsstedet er tegn på, at den rette vaccinationsteknik er anvendt.
English: Maternally derived antibodies may interfere with the response to vaccination.
Danish: Maternelt overførte antistoffer kan påvirke vaccineresponset.
English: Data on two laboratory efficacy studies were provided showing that reduction of PRRS viraemia of pigs vaccinated with the mixed product is similar to the reduction of PRRS viraemia of pigs vaccinated with Porcilis PRRS alone.
Danish: Der blev fremlagt data fra to laboratorievirkningsundersøgelser, som viste, at reduktionen af PRRS-viræmi hos svin, der er vaccineret med det blandede lægemiddel, svarer til reduktionen af PRRS-viræmi hos svin, der er vaccineret med Porcilis PRRS alene.
English: In addition, it was considered that potency of the Porcilis M Hyo component after mixing should have been analysed in order to the exclude a quality interference right after mixing (at t=0) and after the proposed in-use shelf life.
Danish: Desuden var man af den opfattelse, at Porcilis M Hyo-komponentens styrke efter blanding skulle have været analyseret for at udelukke en kvalitetsinterferens lige efter blandingen (ved t=0) og efter den foreslåede holdbarhed ved brug.
English: Since the protective immunity against viraemia is not altered by the mixed administration, the marketing authorisation holder considered that all the other efficacy parameters will also not be altered, and therefore, no more data are required in support of the duration of immunity for the mixed administration.
Danish: Eftersom scoren for beskyttende immunitet mod viræmi ikke ændres med indgivelsen af det blandede lægemiddel, var indehaveren af markedsføringstilladelsen af den opfattelse, at alle de andre virkningsparametre heller ikke ændrer sig, og at det derfor ikke er nødvendigt med flere data til støtte for immunitetsvarigheden for det blandede lægemiddel.
English: As regards why the stability studies were not performed with batches approaching the end of their shelf-life, the marketing authorisation holder has commented that there is no impact on the existing minimum titre proven to be efficacious:
Danish: Hvad angår årsagen til, at stabilitetsundersøgelserne ikke blev foretaget med batcher, hvis holdbarhed var ved at være udløbet, bemærkede indehaveren af markedsføringstilladelsen, at der ikke er nogen effekt på den eksisterende minimumstiter, hvis virkning er dokumenteret:
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Danish: Der foreligger ingen oplysninger om sikkerhed og effekt af vaccinen ved samtidig brug med andre lægemidler til dyr bortset fra den, der er nævnt ovenfor.
English: The marketing authorisation holder has justified the absence of data demonstrating all efficacy claims for the mixed product.
Danish: Indehaveren af markedsføringstilladelsen har begrundet undladelsen af at fremlægge data til påvisning af samtlige påstande for det blandede lægemiddels virkning.
English: The Netherlands
Danish: Nederland
English: Newly introduced PRRS virus-naïve animals (e.g. replacement gilts from PRRS virusnegative herds) should be vaccinated prior to pregnancy.
Danish: Nyligt indkomne dyr, der er PRRS-virus naïve (f.eks. ny gylte fra PRRS-negative besætninger) bør vaccineres før drægtighed.
English: In addition to the above mentioned laboratory studies, the marketing authorisation holder has provided efficacy data for the mixed products of two field studies.
Danish: Foruden de ovennævnte laboratorieundersøgelser fremlagde indehaveren af markedsføringstilladelsen data for virkningen i to feltundersøgelser med det blandede lægemiddel.
English: The lyophilised fraction of Porcilis PRRS (containing the live virus antigen) would be reconstituted in the inactivated vaccine Porcilis M Hyo.
Danish: Den lyofiliserede fraktion af Porcilis PRRS (som indeholder det levende virusantigen) ville blive rekonstitueret i den inaktiverede vaccine Porcilis M Hyo.
English: The results indicated that there was a limited drop in the PRRS virus titre after mixing with Porcilis M Hyo (average drop after the claimed 1 hour in-use shelf life of 0.05 log).
Danish: Resultaterne viste, at der var et begrænset fald i PRRS-virustiter efter blanding med Porcilis M Hyo (gennemsnitligt fald efter den angivne 1 times holdbarhed ved brug på 0,05 log).