FrancophonIA/ELRC3.0 huggingface dataset:
English: The National Competent Authority of Spain was concerned that some aspects regarding the quality and the efficacy after mixing the two products (Porcilis PRRS and Porcilis M Hyo) were not adequately justified.
Danish: Spaniens nationale kompetente myndigheder havde betænkeligheder med hensyn til, at nogle aspekter af kvalitet og virkning efter blandingen af de to lægemidler (Porcilis PRRS og Porcilis M Hyo) ikke var tilstrækkeligt dokumenteret.
English: Breeding pigs: For gilts a (re)vaccination 2-4 weeks before mating is recommended.
Danish: Avlssvin: Det anbefales at (re)vaccinere gylte 2-4 uger før løbning.
English: GROUNDS FOR THE GRANTING OF THE VARIATION OF THE MARKETING AUTHORISATIONS
Danish: BEGRUNDELSER FOR GODKENDELSE AF ÆNDRINGEN AF MARKEDSFØRINGSTILLADELSERNE
English: As regards justifying why no potency test of the Porcilis M Hyo component has been carried out on the mixed vaccines both immediately after mixing and after the proposed in-use shelf life, the marketing authorisation holder has justified not performing a potency test for the Porcilis M Hyo component on the mixed vaccines that by provision of safety and efficacy studies using the mixed product the marketing authorisation holder has shown that there are no interactions within the mixture affecting the potency of the mixed product.
Danish: Hvad angår begrundelserne for, at der ikke blev foretaget nogen styrketest af Porcilis M Hyokomponenten i de blandede vacciner både umiddelbart efter blandingen og efter den foreslåede holdbarhed ved brug, begrundede indehaveren af markedsføringstilladelsen den manglende udførelse af en styrketest for Porcilis M Hyo-komponenten i de blandede vacciner med, at fremlæggelsen af sikkerheds- og virkningsundersøgelser for det blandede lægemiddel havde vist, at der ikke er nogen interaktioner i blandingen, som har indflydelse på det blandede lægemiddels styrke.
English: Marketing Authorisation Holder
Danish: Indehaver af Markedsføringstilladelsen
English: 2.2 Justification of the current claim for Porcilis PRRS concerning a significant improvement of rearing results (reduced morbidity due to PRRS infection, and a better daily growth and feed conversion) until the end of the fattening period when mixed with Porcilis M Hyo.
Danish: 2.2 Begrundelse for den nuværende påstand for Porcilis PRRS vedrørende en væsentlig forbedring af opdrætsresultaterne (lavere morbiditet på grund af PRRSinfektion, og en øget daglig vækst og foderudnyttelse) indtil slutningen af opfedningsperioden, når det blandes med Porcilis M Hyo.
English: Therefore, the specific claim for finishing pigs of “a significant improvement of rearing results (reduced morbidity due to PRRS infection and a better daily growth and feed conversion) until the end of the fattening period” has not been demonstrated and the efficacy of the mixed product has not been proved.
Danish: Den specifikke påstand om ”en væsentlig forbedring af opdrætsresultaterne (lavere morbiditet på grund af PRRSinfektion, og en øget daglig vækst og foderudnyttelse) indtil slutningen af opfedningsperioden” for slagtesvin er således ikke påvist, og virkningen af det blandede lægemiddel er heller ikke påvist.
English: The efficacy studies using appropriate challenges for Porcilis PRRS and Porcilis M Hyo have shown that there is no affect of simultaneous administration on the efficacy parameters of reduced viraemia and a reduction in lung lesions.
Danish: Sikkerhedsundersøgelserne, hvor der anvendes passende belastninger for Porcilis PRRS og Porcilis M Hyo, har vist, at samtidig indgivelse ikke har nogen indvirkning på virkningsparametrene for reduceret viræmi og reduktion af lungelæsioner.
English: 4.8 Interaction with other medicinal products and other forms of interaction Safety and efficacy data for intramuscular injection are available in finishing pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis M Hyo.
Danish: 4.8 Interaktion med andre lægemidler og andre former for interaktion Der foreligger oplysninger om sikkerhed og effekt efter intramuskulær injektion til grise fra 4 ugers-alderen, som viser, at vaccinen kan blandes med Porcilis M Hyo.
English: After mixing with Porcilis M Hyo: 1 hour at room temperature
Danish: Efter blanding med Porcilis M Hyo: 1 time ved stuetemperatur.
English: The marketing authorisation holder was requested to provide additional data and justification that the efficacy claims and duration of immunity of Porcilis PRRS are not altered when the vaccine is administered mixed with Porcilis M Hyo.
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at fremlægge yderligere data og en begrundelse for, at virkningsangivelserne og immunitetsvarigheden for Porcilis PRRS ikke ændres, når vaccinen indgives samtidig med Porcilis M Hyo.
English: 1 CVMP Guideline on data requirements to support in-use stability claims for veterinary vaccines (EMEA/CVMP/IWP/250147/2008-CONSULTATION) - http://www.ema.europa.eu/pdfs/vet/iwp/25014708en.pdf
Danish: 1 CVMP's retningslinjer 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) (EMEA/CVMP/IWP/250147/2008
English: 2.1 In-use shelf-life proposed after mixing the two products (Porcilis PRRS and Porcilis M Hyo)
Danish: 2.1 Foreslået holdbarhed ved brug efter blandingen af de to lægemidler (Porcilis PRRS og Porcilis M Hyo)
English: The variation of concern consists of allowing the mixing of two vaccines, Porcilis PRRS and Porcilis M Hyo, before administration.
Danish: Den pågældende ændring omfatter en tilladelse til at blande to vacciner, Porcilis PRRS og Porcilis M Hyo, før indgivelsen.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: ÆNDRINGER SOM SKAL INKLUDERES I RELEVANTE AFSNIT I PRODUKTRESUMEET
English: Concerning Porcilis M Hyo the marketing authorisation holder has submitted data of adjuvant content (dl-α-tocopherol acetate), pH and sterility of the mixture after reconstitution of 2 batches of Porcilis PRRS in 2 batches of Porcilis M Hyo after storage for 3 hours at room temperature.
Danish: Hvad angår Porcilis M Hyo, har indehaveren af markedsføringstilladelsen fremsendt data om blandingens adjuvansindhold (dl--tocopherolacetat), pH og sterilitet efter rekonstituering af 2 batcher af Porcilis PRRS i 2 batcher af Porcilis M Hyo efter opbevaring i 3 timer ved stuetemperatur.
English: For finishing pigs a single dose is given, which may be administered intradermally or intramuscularly.
Danish: Slagtesvinene gives en enkeltdosis intradermalt eller intramuskulært.
English: No information is available on the safety and efficacy of the use of Porcilis PRRS mixed with Porcilis M Hyo in breeding animals or during pregnancy.
Danish: Der foreligger ingen oplysninger om sikkerhed og effekt ved brug af Porcilis PRRS blandet med Porcilis M Hyo til avlsdyr eller under drægtighed.
English: However the argumentation provided by the marketing authorisation holder to date raised some concerns that by mixing the products some of the efficacy claims for the monovalent products would not be achieved.
Danish: Den argumentation, som indehaveren af markedsføringstilladelsen hidtil har fremført, gav anledning til visse betænkeligheder med hensyn til, hvorvidt nogle af virkningsangivelserne for de monovalente lægemidler opnås, når lægemidlerne blandes.
English: The proposed vaccination scheme for finishing pigs with the mixed product is: first administration of Porcilis M Hyo from one week of age followed by the administration of Porcilis PRRS mixed with Porcilis M Hyo from 4 weeks of age.
Danish: Den foreslåede vaccinationsplan for slagtesvin med det blandede lægemiddel er som følger: Første vaccination med Porcilis M Hyo gives fra 1 uges alderen, hvorefter der gives en vaccination med Porcilis PRRS blandet med Porcilis M Hyo fra 4 ugers alderen.
English: The product literature of Porcilis M Hyo should also be consulted before administration of the mixed product.
Danish: Produktresumeet for Porcilis M Hyo bør læses inden administration af den blandede vaccine.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Danish: ÆNDRINGER SOM SKAL INDFØJES I RELEVANTE AFSNIT I INDLÆGSSEDDEL
English: Belgium Intervet International BV Wim de Körverstraat 35
Danish: Grækenland Intervet International BV Wim de Körverstraat 35
English: A single dose (2 ml) of Porcilis PRRS mixed with Porcilis M Hyo is given intramuscularly in the neck.
Danish: En enkelt dosis (2 ml) af Porcilis PRRS blandet med Porcilis M Hyo gives veddyb intramuskulær injektion i nakken.
English: The marketing authorisation holder has justified that the current duration of immunity for Porcilis PRRS is still supported when the two products are mixed.
Danish: Indehaveren af markedsføringstilladelsen har begrundet, at den aktuelle immunitetsvarighed for Porcilis PRRS stadig er underbygget, når de to lægemidler blandes.
English: Amendments to the summary of product characteristics and package leaflet
Danish: ÆNDRINGER TIL PRODUKTRESUME OG INDLÆGSSEDDEL
English: 12 months (after storage by the manufacturer at ≤-20°C during maximum 12 months) Diluent: in glass vials 4 years, in PET vials 24 months After reconstitution: 3 hours at room temperature.
Danish: 12 måneder (efter opbevaring hos fremstiller ved ≤ -20 C i max. 12 måneder).
English: A significant improvement of rearing results (reduced morbidity due to PRRS infection, an a better daily growth and feed conversion) until the end of the fattening period was observed in vaccinated pigs during field trials, particularly in piglets vaccinated at 6 weeks of age.
Danish: PRRS-infektion og en øget daglig vækst og foderudnyttelse) indtil slutningen af opfedningsperioden hos vaccinerede svin i løbet af feltundersøgelserne, navnlig hos pattegrise, som vaccineres i 6-ugersalderen.
English: The marketing authorisation holder provided data for PRRS virus titres of two batches of Porcilis PRRS reconstituted with each of ten batches of Porcilis M Hyo after 0, 1, 2 and 3 hours of storage at room temperature.
Danish: Indehaveren af markedsføringstilladelsen fremlagde data om PRRS-virustitre for to batcher af Porcilis PRRS rekonstitueret med hver af 10 batcher af Porcilis M Hyo efter opbevaring i 0, 1, 2 og 3 timer ved stuetemperatur.
English: Batch release protocols for the in-use stability studies of Porcilis PRRS and Porcilis M Hyo were provided.
Danish: Der blev fremlagt batchfrigivelsesprotokoller for undersøgelserne af Porcilis PRRS' og Porcilis M Hyos stabilitet ved brug.
English: The marketing authorisation holder has justified by reference to the available data that the current efficacy claims for Porcilis PRRS are still supported when the two products are mixed.
Danish: Indehaveren af markedsføringstilladelsen har ved henvisning til tilgængelige data påvist, at de nuværende påstande om virkningen af Porcilis PRRS stadig er underbygget, når de to lægemidler blandes.
English: 1 CVMP Guideline on requirements for concurrent administration of immunological veterinary medicinal products (EMEA/CVMP/550/02-FINAL) - http://www.ema.europa.eu/pdfs/vet/iwp/055002en.pdf vaccines were mixed resulting in maintenance of the same level of efficacy by investigating one efficacy parameter, reduction in viraemia (reduction of 70-75% after simultaneous use and reduction of 72-75% after use of Porcilis PRRS alone).
Danish: Indehaveren af markedsføringstilladelsen har påvist, at der ikke er nogen immunologisk interferens, når vaccinerne blandes, eftersom undersøgelsen af et virkningsparameter, nemlig reduktionen af viræmi, viste, at der opnås samme virkningsniveau (en reduktion på 70-75 % efter samtidig brug og en reduktion på 72-75 % efter brug af Porcilis PRRS alene).
English: Safety and efficacy data for intramuscular injection are available in finishing pigs from 4 weeks of age onwards, which demonstrate that this vaccine can be mixed with Porcilis M Hyo.
Danish: Der foreligger oplysninger om sikkerhed og virkning i grise fra 4 ugers alderen, som dokumenterer, at vaccinen kan blandes med Porcilis M Hyo.
English: It is indicated for use in breeding and finishing pigs from 2 weeks of age.
Danish: Midlet er indiceret til anvendelse til avlssvin og slagtesvin fra 2-ugersalderen og opad.
English: 100 doses
Danish: 100 doser
English: The marketing authorisation holder considered that, based on the Guideline on requirements for concurrent administration of immunological veterinary medicinal products1, the efficacy data of the individual products, including duration of immunity, can be applied for the concurrent use of them if absence of immunological interference is demonstrated.
Danish: På baggrund af retningslinjerne for samtidig indgivelse af immunologiske veterinærlægemidler ("Guideline on requirements for concurrent administration of immunological veterinary medicinal products1") var indehaveren af markedsføringstilladelsen af den opfattelse, at virkningsdataene for de individuelle lægemidler, herunder
English: The claims of Porcilis PRRS, indications section of SPC (section 4.2) are: “For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus.
Danish: ”Til aktiv immunisering af klinisk sunde svin i et PRRS-kontamineret miljø for at reducere viræmi som følge af infektion med europæiske stammer af PRRS-virus.
English: Do not mix with any other veterinary medicinal product, except the diluent supplied with the product or with Porcilis M Hyo.
Danish: 6.2 Uforligeligheder Må ikke blandes med andre veterinærlægemidler med undtageles af Porcilis M Hyo.
English: It is advised to vaccinate all target pigs within a herd from the earliest recommended age onwards.
Danish: Det anbefales, at alle grise i en besætning, der er 2 uger eller ældre vaccineres.
English: This would support an in-use shelf life of one hour, except for the lack of information necessary to properly evaluate the results: the batch release protocols of the batches used and the protocols with the conditions of the assay were not provided.
Danish: Dette underbygger en holdbarhed ved brug på 1 time, undtagen hvad angår den manglende information, der er nødvendig for at evaluere resultatet korrekt.
English: The marketing authorisation holder has demonstrated that the degree of protection conveyed by the individual products has not been altered by mixing the products by several laboratory challenge studies and field studies.
Danish: Indehaveren af markedsføringstilladelsen har ved hjælp af adskillige challengeundersøgelser og feltundersøgelser påvist, at den grad af beskyttelse, som de individuelle lægemidler giver, ikke ændres, når lægemidlerne blandes.
English: The marketing authorisation holder has provided data of the PRRS virus titration after mixing Porcilis PRRS with Porcilis M Hyo at 0, 1, 2 and 3 hours.
Danish: Indehaveren af markedsføringstilladelsen har fremlagt data for virustitrering 0, 1, 2 og 3 timer efter blanding af Porcilis PRRS med Porcilis M Hyo.
English: The vaccine may be reconstituted shortly before vaccination for simultaneous use with Porcilis M Hyo in finishing pigs from 4 weeks of age and the following instructions should be used:
Danish: Ved samtidig brug med Porcilis M Hyo til slagtesvin fra 4-ugers alderen kan vaccinen anvendes til rekonstitution kort tid før vaccination.
English: 6.2 Incompatibilities
Danish: Specifikke påstande
English: Deseril Tablets 1mg 1mg
Danish: Deseril Tabletter 1mg 1 mg
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Danish: Bilag I Liste over navne, lægemiddelform, styrker, indgivelsesvej, indehavere af markedsføringstilladelse i medlemsstaterne
English: Member State (in EEA)
Danish: Medlemsstat (EU/EAA)
English: Coated tablet
Danish: Overtrukket tablet
English: 2 Bath Road, Chippenham
Danish: Alliance Pharmaceuticals Ltd Avonbridge House 2 Bath Road, Chippenham Wiltshire, SN15 2BB United Kingdom
English: Marketing Authorisation Holder Invented name
Danish: Indehaver af markedsføringstilladelse
English: Date of first authorisation: 27 September 2007 Date of latest renewal: 26 July 2012
Danish: Dato for første markedsføringstilladelse: 27 september 2007 Dato for seneste fornyelse: 26 juli 2012
English: You should not take this medicine when pregnant unless you have discussed this with your doctor.
Danish: Du bør ikke anvende denne medicin under graviditet, medmindre du har talt med din læge om det.
English: Your mouth should be empty before placing the tablet on the tongue.
Danish: Munden bør være tom før tabletten placeres på tungen.
English: The mean increase in olanzapine AUC was 52% and 108% respectively.
Danish: Den gennemsnitlige øgning af olanzapin AUC var henholdsvis 52 % og 108 %.
English: Contains aspartame.
Danish: Indeholder aspartam.
English: • medicines for Parkinson's disease.
Danish: • medicin for Parkinsons sygdom
English: There is a risk of feeling drowsy when you are given Zalasta.
Danish: Der er risiko for døsighed, når du får Zalasta.
English: The mean increase in olanzapine Cmax following fluvoxamine was 54% in female non-smokers and 77% in male smokers.
Danish: Den gennemsnitlige øgning af olanzapin Cmax efter fluvoxamin var 54 % hos kvindelige ikke-rygere og 77 % hos mandlige rygere.
English: Dystonia (including oculogyration) Tardive dyskinesia Amnesia
Danish: Dystoni (inklusive okulogyration) Tardiv dyskinesi Amnesi
English: Hold the blister at the edges and separate one blister cell from the rest of the blister by gently tearing along the perforations around it.
Danish: Hold blisteret i kanterne og adskil en blisterlomme fra resten af blisteret ved forsigtigt at rive langs perforeringen rundt om blisterlommen.
English: You should take your Zalasta tablets once a day following the advice of your doctor.
Danish: Du bør tage Zalasta tabletter én gang dagligt efter din læges anvisning.
English: Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Danish: Forhøjede plasmaprolaktinniveauer blev rapporteret hos 47,4 % af de unge patienter.
English: You should swallow the tablets whole with water.
Danish: Du bør synke Zalasta tabletterne hele med vand.
English: To take a tablet out of the packaging:
Danish: Sådan tager du en tablet ud af pakningen:
English: In patients with Parkinson's disease Zalasta may worsen the symptoms.
Danish: Hos patienter med Parkinsons sygdom kan Zalasta forværre symptomerne.
English: Talk to your doctor or pharmacist before you take Zalasta.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Zalasta.
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Danish: Det kan være skadeligt, hvis du har phenylketonuri (PKU), en sjælden genetisk lidelse, hvor phenylalanin ophobes, fordi kroppen ikke kan fjerne det ordentligt.
English: Zalasta tablets break easily, so you should handle the tablets carefully.
Danish: Zalasta tabletter knækker let, så du bør tage forsigtigt på tabletterne.
English: Do not use epinephrine, dopamine, or other sympathomimetic agents with betaagonist activity since beta stimulation may worsen hypotension.
Danish: Brug ikke adrenalin, dopamin eller andre sympatomimetiske midler med betaagonist aktivitet, da beta stimulation kan forværre hypotension.
English: Children and adolescents Zalasta is not for patients who are under 18 years.
Danish: Børn og unge Zalasta er ikke beregnet til patienter under 18 år.
English: • Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
Danish: • Moderate til svære maniske episoder en tilstand med symptomer som begejstring og eufori.
English: Your doctor may suggest you to reduce the dose gradually before stopping treatment.
Danish: Din læge kan foreslå en gradvis nedtrapning af dosis når behandlingen skal afsluttes.
English: It is important that you carry on taking Zalasta for as long as your doctor tells you.
Danish: Det er vigtigt, du fortsætter med at tage Zalasta, så længe lægen beder dig om det.
English: Zalasta orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Danish: Zalasta smeltetablet bør placeres i munden, hvor den hurtigt vil dispergeres i spyttet, så den let kan synkes.
English: The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Danish: Størrelsen af vægtøgning og andelen af unge patienter, som havde klinisk signifikant vægtøgning, var større ved langvarig eksposition (mindst 24 uger) end ved kortvarig eksposition.
English: Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Danish: Olanzapin er overvejende bundet til albumin og surt 1-glycoprotein.
English: All olanzapine- and placebo-treated patients who experienced a cerebrovascular event had pre-existing risk factors.
Danish: Alle de olanzapin- og placebobehandlede patienter,som oplevede en cerebrovaskulær hændelse, havde præeksisterende risikofaktorer.
English: Zalasta with alcohol
Danish: Brug af Zalasta sammen med alkohol
English: In these trials, patients were initially required to be stable on the lowest effective dose of anti-Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.
Danish: I disse forsøg skulle patienterne initialt være stabiliserede på den lavest effektive dosis af antiparkinsonbehandling (dopaminagonist) og skulle forblive på den samme antiparkinsonbehandling og dosering under hele forsøget.
English: Clinically significant weight gain (≥ 7%) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Danish: Klinisk signifikant vægtøgning (≥ 7 %) synes at forekomme hyppigst i den unge population sammenlignet med ældre med sammelignelig eksposition.
English: It does not matter whether you take them with or without food.
Danish: Det er ligegyldigt, om du tager tabletterne til et måltid eller ej.
English: Dizziness Akathisia Parkinsonism Dyskinesia
Danish: Svimmelhed Akatisi Parkinsonisme Dyskinesi
English: ─ Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Danish: - Fortæl det til lægen, hvis du eller nogen i din familie tidligere har haft blodpropper, da denne type medicin kan være forbundet med dannelse af blodpropper.
English: In two of two placebo and two of three comparator controlled trials with over 2,900 schizophrenic patients presenting with both positive and negative symptoms, olanzapine was associated with statistically significantly greater improvements in negative as well as positive symptoms.
Danish: I 2 ud af 2 placebo- og 2 ud af 3 komparatorkontrollerede studier af mere end 2,900 skizofrene patienter med både positive og negative symptomer blev olanzapin forbundet med statistisk signifikante større forbedringer af negative såvel som af positive symptomer.
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to < 1/10).
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10).
English: Do not handle the tablets with wet hands as the tablets may break up.
Danish: Rør ikke tabletterne med våde hænder, da tabletterne kan gå i stykker.
English: In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Danish: Hos voksne patienter, som fuldførte 9-12 måneders behandling, aftog hyppigheden i stigning af middel blodglucose efter ca. 6 måneder.