FrancophonIA/ELRC3.0 huggingface dataset:
English: Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Danish: Efter gennemgang af PRAC's anbefaling tilsluttede CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) sig de overordnede videnskabelige konklusioner og begrundelsen for anbefalingen.
English: The PRAC concluded that the benefit-risk of the hydroxyzine-containing products remains positive, provided that the agreed changes to the product information and the additional risk minimisation measures are implemented.
Danish: PRAC konkluderede, at benefit/risk-forholdet for produkter indeholdende hydroxyzin fortsat er positivt, forudsat at de vedtagne ændringer af produktinformationen og supplerende risikominimeringsforanstaltninger gennemføres.
English: • The PRAC considered that the available safety data confirms the potential risk of QT interval prolongation associated with the use of hydroxyzine;
Danish: • PRAC fandt, at de foreliggende data bekræfter den potentielle risiko for forlænget QT-interval ved anvendelse af hydroxyzin,
English: 2 - Detailed explanation of the scientific grounds for differences from the PRAC recommendation
Danish: 2 - Detaljeret videnskabelig begrundelse for afvigelserne fra PRAC's anbefaling
English: The PRAC also requested the MAHs to circulate a ‘Direct healthcare professional' communication (DHPC), assess the effectiveness of the risk minimisation measures and continue to monitor the risks of QT interval prolongation, Torsades de Pointes, ventricular arrhythmia, sudden death and cardiac arrest.
Danish: PRAC anmodede derudover markedsføringstilladelsesindehaverne om at udsende en direkte henvendelse til sundhedspersoner (DHPC), vurdere effektiviteten af risikominimeringsforanstaltningerne og fortsat overvåge risiciene for forlænget QT-interval, torsade de pointes, ventrikulær arytmi, pludselig død og hjertestop.
English: • The PRAC reviewed the totality of the available data in relation to the potential risk for developing QT interval prolongation and/or Torsades de Pointes after exposure to hydroxyzine, including pre-clinical data, clinical efficacy and safety data and post-marketing safety data, the MAHs' submissions as well as reports from the Paediatric Committee and the Geriatric Expert Group;
Danish: • PRAC gennemgik alle foreliggende data vedrørende den potentielle risiko for forlænget QTinterval og/eller torsade de pointes efter eksponering for hydroxyzin, herunder prækliniske data, data vedrørende klinisk virkning og sikkerhed samt sikkerhedsdata efter markedsføring, data indsendt af markedsføringstilladelsesindehaverne samt rapporter fra det pædiatriske udvalg og den geriatriske ekspertgruppe,
English: The PRAC considered that the potential risk of QT interval prolongation and Torsades de Pointes can be adequately minimised through appropriate risk minimisation measures targeting the identified risk factors and restricting the use of hydroxyzine, in particular in the atrisk populations.
Danish: PRAC fandt, at den potentielle risiko for forlænget QT-interval og torsade de pointes kan minimeres tilstrækkeligt ved passende risikominimeringsforanstaltninger, der er målrettet mod de påviste risikofaktorer, samt ved begrænsninger i anvendelsen af hydroxyzin, navnlig hos de udsatte patientgrupper.
English: In addition, the CMDh agreed that when implementing the agreed changes to the product information, the MAHs should also revise the posology section as appropriate to introduce any changes consequential to the revised maximum daily dose recommendations.
Danish: Desuden vedtog CMDh, at markedsføringstilladelsesindehaverne som led i de vedtagne ændringer af produktinformationen også skulle revidere doseringsafsnittet svarende til de reviderede anbefalinger for maksimal dagsdosis.
English: The PRAC recommended that hydroxyzine should be contra-indicated in patients with a known acquired or congenital QT interval prolongation as well as in patients with a known risk factor to QT interval prolongation including a known cardiovascular disease, significant electrolytes imbalance (hypokalaemia, hypomagnesaemia), family history of sudden cardiac death, significant bradycardia, concomitant use with other drugs known to prolong the QT interval and/or induce Torsades de Pointes.
Danish: PRAC anbefalede, at hydroxyzin skal være kontraindiceret ved kendt erhvervet eller medfødt forlænget QT-interval og ved kendte risikofaktorer for forlænget QT-interval, herunder kendt kardiovaskulær sygdom, nævneværdige elektrolytforstyrrelser (hypokaliæmi, hypomagnesiæmi), familiær anamnese med pludselig hjertedød, nævneværdig bradykardi og samtidig anvendelse af andre lægemidler, der vides at forlænge QT-intervallet og/eller fremkalde torsade de pointes.
English: • The PRAC considered the known risk factors for QT interval prolongation and was of the opinion that the potential risk for QT interval prolongation can be adequately minimised by restricting the use of hydroxyzine, particularly in at-risk patient populations;
Danish: • PRAC gennemgik de kendte risikofaktorer for forlænget QT-interval og er af den opfattelse, at den potentielle risiko for forlænget QT-interval kan minimeres tilstrækkeligt ved at begrænse anvendelsen af hydroxyzin, navnlig hos udsatte patientpopulationer,
English: The PRAC reviewed all available data, including pre-clinical data, clinical efficacy and safety data and post-marketing safety data, as well as input from the PDCO and the GEG, in the context of its review of the potential risk for developing QT interval prolongation and Torsades de Pointes after exposure to hydroxyzine.
Danish: PRAC gennemgik alle foreliggende data, herunder prækliniske data, data vedrørende klinisk virkning og sikkerhed, sikkerhedsdata efter markedsføring samt input fra det pædiatriske udvalg og den geriatriske ekspertgruppe, som led i gennemgangen af den potentielle risiko for forlænget QT-interval og torsade de pointes efter eksponering for hydroxyzin.
English: This potential risk was confirmed by clinical and post-marketing data, which also identified the at-risk population as consisting of patients with risk factors for QT interval prolongation, such as cardiac medical history, concomitant medications associated with QT interval prolongation and electrolyte imbalance.
Danish: Denne potentielle risiko bekræftedes af kliniske data og data efter markedsføring, som ligeledes viste, at den udsatte gruppe var patienter med risikofaktorer for forlænget QT-interval såsom hjertesygdom i anamnesen, sideløbende behandling med lægemidler, der forlænger QT-intervallet, og elektrolytforstyrrelser.
English: • The PRAC agreed on measures including a revision of the posology, contraindications in patients with a known acquired or congenital QT interval prolongation and patients with a known risk factor to QT interval prolongation, a warning that use in the elderly is not recommended due to the anticholinergic effect and a request to the MAHs to assess the effectiveness of the risk minimisation measures.
Danish: • PRAC vedtog foranstaltninger bestående i revision af doseringen, kontraindikation ved kendt erhvervet eller medfødt forlænget QT-interval og ved kendte risikofaktorer for forlænget QTinterval, en advarsel, der fraråder anvendelse hos ældre pga. den antikolinerge virkning, og en anmodning om, at markedsføringstilladelsesindehaverne vurderer effektiviteten af risikominimeringsforanstaltningerne,
English: (the half-life in children 12 months of age is 4 hours, compared to 11 hours for children aged 14 years, 14 hours in adults and 29 hours in the elderly).
Danish: CMDh bemærkede, at de ved proceduren gennemgåede farmakokinetiske data viser, at halveringstiden for hydroxyzin synes at tiltage lineært med alderen (halveringstiden hos børn på 12 måneder er 4 timer, sammenholdt med 11 timer hos børn på 14 år, 14 timer hos voksne og 29 timer hos ældre).
English: Whereas
Danish: Bilag II
English: The CMDh amended the product information accordingly, revising the wording of Section 4.2 of the SmPC as follows: “In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day” and clarifying the wording of the recommendation in children up to 40 kg in weight.
Danish: Da 40 kg sædvanligvis anses for at svare til vægten af et barn på 12 år, fandt CMDh ud fra de foreliggende farmakokinetiske data, at den maksimale dagsdosis på 100 mg til voksne også måtte anses for passende for børn på over 40 kg. CMDh ændrede produktinformationen i henhold hertil ved revision af ordlyden af produktresuméets punkt 4.2 som følger: “Hos voksne og børn med en legemsvægt på over 40 kg er den maksimale daglige dosis 100 mg” med præcisering af ordlyden af anbefalingerne for børn, der vejer op til 40 kg. Ordlyden af indlægssedlens afsnit 3 blev ændret tilsvarende.
English: Overall conclusion and grounds for the variation to the Marketing Authorisations
Danish: Videnskabelige konklusioner og begrundelse for ændring af markedsføringstilladelserne ud fra følgende betragtninger:
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelse for ændring af betingelserne for markedsføringstilladelserne samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering)
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the hydroxyzinecontaining products identified in Annex I remains favourable, subject to the agreed amendments to the product information and additional pharmacovigilance activities and additional risk minimisation measures.
Danish: konkluderede PRAC, at benefit/risk-forholdet for de i bilag I nævnte lægemidler indeholdende hydroxyzin fortsat er positivt under forudsætning af de vedtagne ændringer af produktinformationen,
English: EU Number Invented name Strength Pharmaceutical form
Danish: EU Nummer Særnavn Styrke Lægemiddelform
English: Package size l t o r
Danish: r l g
English: Route of administration Packaging Content
Danish: Indholdsmængde Pakkestørrelser
English: No special precautions are required.
Danish: Der kræves ingen særlige forholdsregler.
English: These studies were performed under laboratory as well as under typical European farming conditions.
Danish: Undersøgelserne er udført i laboratoriet og under typiske europæiske landbrugsforhold.
English: This summary was last updated in March 2017.
Danish: Dette sammendrag blev sidst ajourført i 03-2017.
English: The vaccine starts to be effective 2 weeks after vaccination and protection lasts for 17 weeks.
Danish: Vaccinen begynder at virke 2 uger efter vaccinationen, og beskyttelsen varer i 17 uger.
English: It is given by injection into the muscle as a single dose.
Danish: Det gives ved injektion i en muskel som en enkeltdosis.
English: In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus.
Danish: Derefter vil immunsystemet fremover kunne reagere hurtigere mod virusset, når det udsættes for virusset.
English: This medicine is the same as Ingelvac CircoFLEX, which is already authorised in the European Union (EU).
Danish: Lægemidlet er identisk med Ingelvac CircoFLEX, som allerede er godkendt i Den Europæiske Union (EU).
English: This active immune response will help to protect the pig against the disease caused by this virus.
Danish: Denne aktive immunreaktion er med til at beskytte svinet mod sygdommen forårsaget af virusset.
English: The full EPAR for Ingelvac PCV Flex can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ingelvac PCV Flex findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The most common side effect with Ingelvac PCV Flex (which may affect more than 1 in 10 animals) is a mild and short lived increase in body temperature on the day of vaccination.
Danish: Den hyppigste bivirkning ved Ingelvac PCV Flex (som kan optræde hos mere end 1 ud af 10 dyr) er let, kortvarig stigning i kropstemperaturen på vaccinationsdagen.
English: The withdrawal period for meat from pigs treated with Ingelvac PCV Flex is ‘zero days', which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Ingelvac PCV Flex, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ingelvac PCV Flex on 24 May 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Ingelvac PCV Flex den 24/05/2017.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Ingelvac PCV FLEX's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Ingelvac PCV Flex opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The company that makes Ingelvac CircoFLEX has agreed that its scientific data can be used for Ingelvac PCV Flex (‘informed consent').
Danish: Virksomheden, som fremstiller Ingelvac CircoFLEX, har indvilget i, at dens videnskabelige oplysninger må anvendes for Ingelvac PCV Flex (informeret samtykke).
English: This is a summary of the European public assessment report (EPAR) for Ingelvac PCV Flex.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ingelvac PCV Flex.
English: The trials showed that vaccination of pigs (which had no antibodies to PCV2 before vaccination) with Ingelvac PCV Flex reduced the levels of PCV2 in the blood, clinical signs of PCV2 infection, virus excreted from the nose and death rates.
Danish: Undersøgelserne viste, at vaccination af svin (som ikke havde antistoffer mod PCV2 før vaccinationen) med Ingelvac PCV Flex nedsatte indholdet af PCV2 i blodet, de kliniske tegn på infektion med PCV2, virusudskillelsen gennem trynen og dødeligheden.
English: PCV2 infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty breathing, pale skin and jaundice (yellowing of the skin).
Danish: Infektion med porcint circovirus type 2 (PCV2) kan frembringe kliniske tegn såsom vægttab eller manglende vækst, forstørrede lymfeknuder, vejrtrækningsbesvær, bleg hud og gulsot.
English: For the full list of restrictions and all side effects reported with Ingelvac PCV Flex, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og indberettede bivirkninger med Ingelvac PCV Flex fremgår af indlægssedlen.
English: Ingelvac PCV Flex has been studied in a number of trials involving pigs of various breeds.
Danish: Ingelvac PCV Flex er undersøgt i en række undersøgelser med forskellige svineracer.
English: Ingelvac PCV Flex is available as a suspension for injection and can only be obtained with a prescription.
Danish: Ingelvac PCV Flex fås som injektionsvæske, suspension, og udleveres kun efter recept.
English: Ingelvac PCV Flex is to be used in pigs which have no maternally derived antibodies (a special type of proteins, received from the mother in the milk that help the body to fight infection) to PCV2.
Danish: Ingelvac PCV Flex anvendes hos svin, der ikke har antistoffer mod PCV2 fra moderen (en særlig type proteiner, der modtages fra moderen gennem mælken og hjælper kroppen til at bekæmpe infektioner).
English: Ingelvac PCV Flex is a vaccine.
Danish: Ingelvac PCV Flex er en vaccine.
English: When a pig is given the vaccine, the pig's immune system recognises the protein as ‘foreign' and reacts by building up an active immune response.
Danish: Når Ingelvac PCV Flex gives til svin, registrerer dyrenes immunsystem proteinet som "fremmed" og reagerer ved at opbygge en aktiv immunreaktion.
English: Ingelvac PCV Flex is a vaccine used to protect pigs from two weeks of age against porcine circovirus type 2 (PCV2).
Danish: Ingelvac PCV Flex er en vaccine til beskyttelse af svin fra 2-ugers alderen mod porcint circovirus type 2 (PCV2).
English: Ingelvac PCV Flex porcine circovirus type 2 vaccine
Danish: Ingelvac PCV Flex porcint circovirus type 2-vaccine
English: Ingelvac PCV Flex contains the active substance porcine circovirus type 2 ORF2 protein.
Danish: Ingelvac PCV Flex indeholder det aktive stof porcint circovirus type 2 ORF2 protein.
English: What is Ingelvac PCV Flex and what is it used for?
Danish: Hvad er Ingelvac PCV Flex, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Ingelvac PCV Flex.
Danish: Det er ikke en praktisk vejledning i, hvordan Ingelvac PCV Flex bør anvendes.
English: For more information about treatment with Ingelvac PCV Flex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Ingelvac PCV Flex, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Ingelvac PCV Flex, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Ingelvac PCV Flex, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Other information about Ingelvac PCV Flex:
Danish: Andre oplysninger om Ingelvac PCV Flex
English: Why is Ingelvac PCV Flex approved?
Danish: Hvorfor er Ingelvac PCV Flex blevet godkendt?
English: What are the risks associated with Ingelvac PCV Flex?
Danish: Hvilke risici er der forbundet med Ingelvac PCV Flex?
English: How is Ingelvac PCV Flex used?
Danish: Hvordan anvendes Ingelvac PCV Flex?
English: Ingelvac PCV Flex contains small amounts of a protein from PCV2.
Danish: Vaccinen indeholder en lille smule af et protein fra PCV2.
English: What benefits of Ingelvac PCV Flex have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ingelvac PCV Flex?
English: Medicinal Product no longer authorised
Danish: Lægemidlet er ikke længere autoriseret til salg
English: Package size
Danish: Indhold Pakningsstørrelse
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Danish: Særnavn Styrke
English: Content
Danish: Emballage
English: This usually takes between 15 and 30 minutes.
Danish: Det tager som regel mellem 15 og 30 minutter.
English: Date of first authorisation: 18 December 2007 Date of latest renewal: 20 December 2012
Danish: Dato for første markedsføringstilladelse: 18. december 2007 Dato for seneste fornyelse: 20. december 2012
English: The dose should remain the same while the change is being made.
Danish: Dosis bør være den samme, mens ændringen gennemføres.
English: Long-term carcinogenicity studies have not been carried out.
Danish: Der er ikke foretaget langtids-karcinogenicitetsforsøg.
English: Fe-incorporation rate.
Danish: Fe-optagelsesrate.
English: Weight (kg)
Danish: Vægt (kg)
English: These may be more common at the start of treatment.
Danish: Disse kan være mere almindelige ved starten af behandlingen.
English: It may be necessary to add or increase anti-hypertensive treatment.
Danish: Det kan være nødvendigt at tilføje eller øge antihypertensiv behandling.
English: A half-life of approximately 6 hours has been reported in children.
Danish: En halveringstid på ca. 6 timer er rapporteret hos børn.
English: Under no circumstances should you attempt to inject yourself unless you have been trained to do so.
Danish: De bør under ingen omstændigheder forsøge selv at foretage indsprøjtninger, medmindre De er blevet undervist i det.
English: These doses may not be as high as those received initially.
Danish: Disse doser er måske ikke så høje som de doser, De fik i begyndelsen.
English: Do not use a double dose to make up for a forgotten dose.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: This should improve during the course of the treatment.
Danish: Dette skulle blive bedre i løbet af behandlingen.
English: The dose should be administered over at least 1-5 minutes, depending on the total dose.
Danish: Dosis skal administreres over mindst 1-5 minutter, afhængigt af den totale dosis.
English: Additional supportive care should be provided as necessary.
Danish: Yderligere støttende pleje skal gives efter behov.
English: There is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.
Danish: Der sker ingen akkumulering: Niveauerne er de samme, uanset om de bestemmes 4 timer efter første injektion eller 24 timer efter sidste injektion.
English: The treatment is divided into two stages: 1.
Danish: Behandlingen inddeles i to faser: 1.
English: The recommended dosing regimen is described in the following diagram:
Danish: Den anbefalede dosis er angivet i følgende diagram:
English: ESAs are not indicated for use in this patient population.
Danish: ESA'er er ikke indiceret til brug hos denne patientpopulation.
English: • you know or think it may have been accidentally frozen
Danish: • De ved eller tror, at den ved et uheld har været frosset
English: Do not to stop the treatment without consultation of your doctor.
Danish: De må ikke afbryde behandlingen uden at rådføre Dem med Deres læge.
English: Summary of the safety profile
Danish: Sammenfatning af sikkerhedsprofil
English: D-25436 Uetersen Germany
Danish: D-25436 Uetersen Tyskland
English: The therapeutic margin of erythropoietin is very wide.
Danish: Den terapeutiske margin for erythropoietin er meget bred.
English: Depending on your individual situation a blood transfusion may be preferable.
Danish: Afhængig af deres situation,kan en blodtransfusion være at foretrække.
English: All special warnings and precautions associated with autologous predonation programmes, especially routine volume replacement, should be respected.
Danish: Alle særlige advarsler og forholdsregler, som associeres med autologe prædonationsprogrammer, især rutinemæssig volumenerstatning, skal respekteres.
English: You should discuss this information with your doctor.
Danish: De bør diskutere disse oplysninger med Deres læge.
English: The protein moiety of the molecule contributes about 58% of total molecular weight and consists of 165 amino acids.
Danish: Proteinandelen af molekylet udgør ca. 58 % af den samlede molekylvægt og består af 165 aminosyrer.
English: Always follow these instructions when using Silapo:
Danish: Følg altid disse anvisninger, når De bruger Silapo:
English: 95% CI for Mean Prior Transfusions
Danish: 95 % CI for middelværdi Tidligere transfusioner
English: Each syringe should be used for a single injection only.
Danish: Hver sprøjte må kun anvendes til en enkelt indsprøjtning.
English: A maximum volume of 1 ml at one injection site should generally not be exceeded.
Danish: Et maksimalt volumen på 1 ml på ét injektionssted bør generelt ikke overskrides.
English: If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.
Danish: Hvis De har disse symptomer under en intravenøs injektion, kan en langsommere indgift af injektionen hjælpe med at undgå dem i fremtiden.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Denne lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Its use in this indication must be balanced against the reported risk of thromboembolic events.
Danish: Anvendelsen på denne indikation skal afvejes mod den rapporterede risiko for tromboemboli-hændelser.
English: Inject the solution as you have been shown by your doctor.
Danish: Indsprøjt opløsningen sådan, som Deres læge har vist Dem.