FrancophonIA/ELRC3.0 huggingface dataset:
English: Porcine circovirus type 2 (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: Infektioner med porcint circovirus type 2 (PCV2) kan medføre kliniske tegn såsom vægttab eller manglende vækst, forstørrede lymfeknuder, vejrtrækningsbesvær, bleg hud og gulsot.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Suvaxyn Circo+MH RTU'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 Suvaxyn Circo+MH RTU opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The vaccine contains small amounts of a protein from PCV2 and whole Mycoplasma hyopneumoniae bacteria that have been killed (inactivated) so that they do not cause disease.
Danish: Vaccinen indeholder små mængder af et protein fra PCV2 og hele Mycoplasma hyopneumoniae-bakterier, som er dræbt (inaktiveret), så de ikke forårsager sygdom.
English: Suvaxyn Circo+MH RTU also contains adjuvants (ingredients that strengthen the immune response) called squalene, poloxamer 401 and polysorbate 80.
Danish: Suvaxyn Circo+MH RTU indeholder også hjælpestoffer (ingredienser, som styrker immunreaktionen) kaldet squalen, poloxamer 401 og polysorbat 80.
English: The effectiveness of Suvaxyn Circo+MH RTU against PCV2 infection was also studied in three field studies.
Danish: Effektiviteten af Suvaxyn Circo+MH RTU mod PCV2-infektion blev også undersøgt i tre feltundersøgelser.
English: The purpose of these studies was to establish how long it took pigs to be fully protected and how long the protection against PCV2 and Mycoplasma hyopneumonia lasted.
Danish: Undersøgelserne skulle fastlægge, hvor lang tid det tog for svin at opnå fuld beskyttelse, og hvor længe beskyttelsen mod PCV2 og Mycoplasma hyopneumoniae varede.
English: The studies showed that the vaccine had its full effect against PCV2 and Mycoplasma hyopneumonia by three weeks after vaccination.
Danish: Undersøgelserne viste, at vaccinen havde fuld virkning mod PCV2 og Mycoplasma hyopneumoniae tre uger efter vaccinationen.
English: The most common side effect with Suvaxyn Circo+MH RTU (which may affect more than 1 in 10 pigs) are an increase in body temperature (on average 1 °C) in the first 24 hours after vaccination which resolves within 48 hours without treatment.
Danish: Den hyppigste bivirkning ved Suvaxyn Circo+MH RTU (som kan optræde hos mere end 1 ud af 10 svin) er temperaturforhøjelse (gennemsnitligt 1°C) de første 24 timer efter vaccination.
English: This is a summary of the European public assessment report (EPAR) for Suvaxyn Circo+MH RTU.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Suvaxyn Circo+MH RTU.
English: Mycoplasma hyopneumoniae infection in pigs causes a disease of the airways called enzootic pneumonia.
Danish: Infektion med Mycoplasma hyopneumoniae hos svin medfører en luftvejssygdom kaldet enzootisk pneumoni.
English: Protection lasted 23 weeks after vaccination for PCV2 and Mycoplasma hyopneumonia.
Danish: Beskyttelsen varede i 23 uger efter vaccination mod PCV2 og Mycoplasma hyopneumoniae.
English: Suvaxyn Circo+MH RTU is a vaccine.
Danish: Suvaxyn Circo+MH RTU er en vaccine.
English: Suvaxyn Circo+MH RTU contains inactivated (killed) active substances derived from porcine circovirus type 2 and Mycoplasma hyopneumoniae bacteria.
Danish: Suvaxyn Circo+MH RTU indeholder inaktiverede (dræbte) aktive stoffer afledt af porcin circovirus type 2 og Mycoplasma hyopneumoniae-bakterien.
English: When Suvaxyn Circo+MH RTU is given to pigs the animals' immune system recognises the viral protein and bacteria as ‘foreign' and makes antibodies against them.
Danish: Når Suvaxyn Circo+MH RTU gives til svin, registrerer dyrenes immunsystem virusproteinet og bakterierne som "fremmede" og reagerer ved at danne antistoffer mod dem.
English: This will help protect the pigs against porcine circovirus and Mycoplasma hyopneumoniae infections.
Danish: Derved bliver svinene beskyttet mod infektioner med porcint circovirus og Mycoplasma hyopneumoniae.
English: Suvaxyn Circo+MH RTU, which is available as a liquid for injection, is given to pigs from three weeks of age as a single injection into the muscle in the neck behind the ear.
Danish: Suvaxyn Circo+MH RTU, der fås som injektionsvæske, gives til svin fra treugersalderen som en enkelt injektion i nakkemuskulaturen bag øret.
English: Suvaxyn Circo+MH RTU is a veterinary vaccine used to protect pigs over the age of 3 weeks against infections with porcine circovirus and the bacteria Mycoplasma hyopneumoniae.
Danish: Suvaxyn Circo+MH RTU er en vaccine til dyr til beskyttelse af svin over tre uger mod infektion med porcint circovirus og bakterien Mycoplasma hyopneumoniae.
English: The field studies showed that Suvaxyn Circo+MH RTU reduced the PCV2 viraemia (presence of virus in the blood) compared to pigs given dummy vaccination.
Danish: Feltundersøgelserne viste, at Suvaxyn Circo+MH RTU nedsatte PCV2-virusindholdet i blodet (viræmi) mere end hos svin, der fik en virkningsløs vaccination.
English: It is not intended to provide practical advice on how to use Suvaxyn Circo+MH RTU.
Danish: Det er ikke en praktisk vejledning i, hvordan Suvaxyn Circo+MH RTU bør anvendes.
English: Suvaxyn Circo+MH RTU is only available on prescription.
Danish: Suvaxyn Circo+MH RTU udleveres kun efter recept.
English: What is Suvaxyn Circo+MH RTU and what is it used for?
Danish: Hvad er Suvaxyn Circo+MH RTU, og hvad anvendes det til?
English: For more information about treatment with Suvaxyn Circo+MH RTU, 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 Suvaxyn Circo+MH RTU, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Why is Suvaxyn Circo+MH RTU approved?
Danish: Hvorfor er Suvaxyn Circo+MH RTU blevet godkendt?
English: For the full list of all side effects reported with Suvaxyn Circo+MH RTU, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Suvaxyn Circo+MH RTU fremgår af indlægssedlen.
English: What are the risks associated with Suvaxyn Circo+MH RTU?
Danish: Hvilke risici er der forbundet med Suvaxyn Circo+MH RTU?
English: For practical information about using Suvaxyn Circo+MH RTU, 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 Suvaxyn Circo+MH RTU, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Other information about Suvaxyn Circo+MH RTU?
Danish: Andre oplysninger om Suvaxyn Circo+MH RTU
English: How is Suvaxyn Circo+MH RTU used?
Danish: Hvordan anvendes Suvaxyn Circo+MH RTU?
English: What benefits of Suvaxyn Circo+MH RTU have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Suvaxyn Circo+MH RTU?
English: No further amendments were considered necessary.
Danish: Der blev ikke fundet behov for yderligere ændringer.
English: There was no evidence for differences between these medicinal products in terms of beneficial effects.
Danish: Der var ingen evidens for forskelle mellem disse lægemidler hvad angår deres gavnlige virkning.
English: For dienogest and nomegestrol studies are on going and results will be submitted when available.
Danish: For dienogest og nomegestrol pågår undersøgelser, og resultaterne heraf vil blive indsendt, når de foreligger.
English: 1 - Overall summary of the scientific evaluation
Danish: 1 - Samlet resumé af den videnskabelige vurdering
English: Having assessed all the available data, the PRAC concluded that:
Danish: Efter gennemgang af samtlige foreliggende data konkluderede PRAC, at:
English: Scientific conclusions and grounds for the conclusions
Danish: Videnskabelige konklusioner og begrundelse for konklusionerne
English: These are combined with varying doses of ethinylestradiol (EE) or with estradiol (E2).
Danish: Disse stoffer kombineres med forskellige doser ethinylestradiol (EE) eller med estradiol (E2).
English: Overall, venous thromboembolic events (VTE) could be fatal in 1-2% of the cases.
Danish: Samlet kan venøse tromboemboliske hændelser være fatale i 1-2 % af tilfældene.
English: After an initially higher risk during the first year of use, the risk decreases to a constant lower level.
Danish: Efter en høj initial risiko i det første år falder risikoen til et konstant, lavere niveau.
English: Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions and grounds for recommendation.
Danish: Efter gennemgang af PRAC's anbefaling tilsluttede CHMP sig de overordnede videnskabelige konklusioner og begrundelsen for anbefalingen.
English: Further changes to the product information will contribute to better inform the healthcare professionals and women on the risk of thromboembolism.
Danish: Yderligere ændring af produktinformationen vil bidrage til bedre oplysning af sundhedspersoner og kvinder om risikoen for tromboemboli,
English: Misdiagnosis is possible, since TE presents with diffuse symptoms and is a rare event in a population of healthy young women.
Danish: Fejldiagnose er mulig, da tromboemboliske hændelser giver diffuse symptomer og er en sjælden hændelse hos populationen af raske unge kvinder.
English: Grounds for the variation to the terms of the marketing authorisations
Danish: Begrundelse for ændringen af betingelserne for markedsføringstilladelserne
English: Considering that risk factors for VTE change over time the PRAC noted that an individual's risk should be re-evaluated periodically.
Danish: Da risikofaktorerne for venøs tromboemboli ændrer sig med tiden, bemærkede PRAC, at en persons individuelle risiko bør revurderes med jævne mellemrum.
English: The following sentence was therefore inserted in the Pregnancy section of the SmPC:
Danish: Der blev derfor indsat følgende sætning i afsnittet Graviditet i produktresuméet:
English: In February 2013, the French medicines agency (ANSM) initiated a referral procedure under Article 31 of Directive 2001/83/EC on the basis that the benefit-risk balance of these combined hormonal contraceptives had become unfavourable in the currently authorised indication of contraception due to the increased risk of thromboembolism (TE) and therefore it was in the interest of the Union to refer the matter to the PRAC.
Danish: I februar 2013 indledte den franske lægemiddelstyrelse (ANSM) en indbringelsesprocedure i medfør af artikel 31 i direktiv 2001/83/EF med den begrundelse, at benefit/risk-forholdet for disse kombinerede hormonale kontraceptiva var blevet negativt til den nuværende godkendte indikation antikonception som følge af den øgede risiko for tromboemboli (TE), og at det derfor var i i EU's interesse at indbringe sagen for PRAC.
English: For comparison, in women who are not using CHCs (no-users) and who are not pregnant, there will be around 2 cases of VTE each year per 10,000 women.
Danish: Til sammenligning vil der hos kvinder, som ikke bruger kombinerede hormonale kontraceptiva (ikke-brugere) og ikke er gravide, forekomme omkring 2 tilfælde af venøs tromboemboli årligt pr. 10 000 kvinder.
English: Thromboembolic events are adverse events which usually occur in a vein of the leg (deep vein thrombosis, DVT).
Danish: Tromboemboliske hændelser er uønskede hændelser, der sædvanligvis forekommer i en vene i benet (dyb venetrombose, DVT).
English: The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for Evra, Ioa and Zoely should be varied.
Danish: Efter gennemgang af PRAC's anbefaling af 10. oktober 2013 i medfør af artikel 107k, litra 3), i direktiv 2001/83/EF er CHMP af den opfattelse, at markedsføringstilladelserne for Evra, Ioa og Zoely bør ændres.
English: It has been shown that risk of VTE is highest during the first year a woman starts hormonal contraceptives or when she re-starts after a period of non-use of at least one month (Dinger et al,.
Danish: Risikoen for venøs tromboemboli er påvist at være højst i det første år, hvor kvinden begynder på hormonal antikonception, og ved genoptagelse af behandlingen efter en pause på mindst én måned (Dinger et al,.
English: In addition the marketing authorisation holders of chlormadinone should perform a post-authorisation safety study.
Danish: Desuden skal markedsføringstilladelsesindehaverne for chlormadinon udføre en sikkerhedsundersøgelse efter markedsføring.
English: For some products (i.e. chlormadinone, dienogest, nomegestrol) there are currently insufficient data to establish the risk compares with the lower risk products.
Danish: For nogle produkter (dvs. chlormadinon, dienogest, nomegestrol) foreligger der på nuværende tidspunkt ikke tilstrækkelige data til at sammenligne risiciene med produkter med lavere risiko.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for the combined hormonal contraceptives containing medicinal products.
Danish: • udvalget fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende hormonale kontraceptiva,
English: The revised Summary of Product Characteristics (SmPC) and Package Leaflet (PL) are set out in the respective annexes I and IIIB for Evra, Ioa and Zoely.
Danish: Det reviderede produktresumé og den reviderede indlægsseddel fremgår af de pågældende bilag I og IIIB for Evra, Ioa og Zoely.
English: For chlormadinone this will be investigated through a post-authorisation safety study, which is further discussed below.
Danish: For chlormadinon vil dette blive genstand for en sikkerhedsundersøgelse efter markedsføring, som er nærmere omtalt nedenfor.
English: When diagnosis is not made and no treatment is started, or when clear symptoms of thrombosis are not identifiable, the clot can move upwards to the lung (pulmonary embolism, PE) or the brain (cerebral embolism, CE).
Danish: Ved manglende diagnosticering og behandling eller i mangel af klare symptomer på trombose kan blodproppen bevæge sig opad til lungerne (lungeemboli) eller hjernen (hjerneemboli).
English: Based on the totality of the available data the PRAC concluded that the risk of VTE differs between products - with the lower risk products being those containing the progestogens levonorgestrel, norethisterone and norgestimate.
Danish: På grundlag af samtlige foreliggende data konkluderede PRAC, at risikoen for venøs tromboemboli er forskellige for forskellige produkter - idet produkterne med lavere risiko er dem, der indeholder progestogenerne levonorgestrel, norethisteron og norgestimat.
English: The risk of VTE is also higher in the presence of intrinsic risk factors.
Danish: Risikoen for venøs tromboemboli er desuden højere i tilstedeværelse af risikofaktorer.
English: However, the CHMP considered that the section on Fertility, pregnancy and lactation of the SmPC should be amended to reflect the increased risk of VTE in the post-partum period, to ensure consistency with the warning section of the SmPC.
Danish: CHMP fandt imidlertid, at afsnittet om fertilitet, graviditet og amning i produktresuméet bør ændres, så det afspejler den øgede risiko for venøs tromboemboli post partum for at sikre overensstemmelse med produktresuméets afsnit med advarsler.
English: The current review confirmed the previous understanding that the level of VTE risk with CHCs containing low dose of ethinylestradiol (ethinylestradiol <50µg) is small, but differences in the VTE risk were observed between most products depending on the type of progestogen they contain.
Danish: Nærværende gennemgang bekræftede den tidligere opfattelse, at risikoen for venøs tromboemboli med kombinerede hormonale kontraceptiva indeholdende en lav dosis ethinylestradiol (ethinylestradiol <50 µg) er lille, men der blev konstateret forskelle i risikoen for venøs tromboemboli mellem størstedelen af produkterne, afhængigt af den type progestogen, de indeholder.
English: • The PRAC is of the opinion that the benefits of combined hormonal contraceptive containing medicinal products continue to outweigh the risks in the indication of contraception.
Danish: • det er PRAC's opfattelse, at fordelene ved lægemidler indeholdende kombinerede hormonale kontraceptiva fortsat overstiger risiciene til indikationen antikonception,
English: Many studies have evaluated the risk of VTE and its complications (deep vein thrombosis, pulmonary embolism) among users of different CHCs.
Danish: Mange undersøgelser har vurderet risikoen for venøs tromboemboli og dens komplikationer (dyb venetrombose, lungeemboli) hos brugerne af forskellige kombinerede hormonale kontraceptiva.
English: In addition the PRAC imposed a post-authorisation safety study in order to better characterise the relative risk of thromboembolic events due to chlormadinone compared to the levonorgestrelcontaining medicinal products.
Danish: Derudover påbød PRAC en sikkerhedsundersøgelse efter markedsføringstilladelse til bedre karakterisering af den relative risiko for tromboemboliske hændelser med chlormadinon i forhold til produkter indeholdende levonorgestrel.
English: In particular, these medicinal products should be contraindicated in patients with multiple risk factors, in patients after major surgery with prolonged immobilisation, patients who smoke and patients with history or hereditary predisposition of thromboembolism.
Danish: Herunder bør sådanne lægemidler være kontraindiceret hos patienter med flere risikofaktorer, hos patienter, der har gennemgået større operationer med langvarig immobilisering, patienter, der ryger, og patienter med tidligere tromboemboli eller familiær tromboemboli i anamnesen.
English: • The estimated incidence of risk is higher with the progestogens etonogestrel and norelgestromin, with between 6 and 12 cases yearly per 10,000 women.
Danish: • Den beregnede risiko er højere med progestogenerne etonogestrel og norelgestromin, for hvilke den er mellem 6 og 12 tilfælde årligt per 10 000 kvinder.
English: Known risk factors for VTE include history of VTE, pregnancy, trauma, surgery, immobilisation (e.g. after surgery or long flights), obesity and smoking (i.e. all situations of a pro-thrombotic state).
Danish: Kendte risikofaktorer for venøs tromboemboli er tidligere venøs tromboemboli, graviditet, traumer, operationer, immobilisering (f.eks. efter operationer eller lange flyrejser), fedme og rygning (dvs. situationer svarende til en protrombotisk tilstand).
English: • The estimated incidence of risk is also higher with the progestogens gestodene, desogestrel, drospirenone, with between 9 and 12 cases yearly per 10,000 women.
Danish: • Den beregnede risiko er desuden højere med progestogenerne gestoden, desogestrel og drospirenon, for hvilke den er mellem 9 og 12 tilfælde årligt per 10 000 kvinder.
English: Medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol are authorised in the European Union as combined hormonal contraceptives (CHCs).
Danish: Lægemidler indeholdende chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat og nomegestrol er godkendt i EU som kombinerede hormonale kontraceptiva.
English: • The PRAC considered that further data are required for the combined hormonal contraceptives containing chlormadinone and imposed the conduct of a post authorisation safety study (PASS) to evaluate the relative risk of thromboembolic events due to these products compared to the ones containing levonorgestrel.
Danish: • PRAC fandt behov for flere data om kombinerede hormonale kontraceptiva indeholdende chlormadinon og påbød en sikkerhedsundersøgelse efter markedsføringsgodkendelse (PASS) til vurdering af den relative risiko for tromboemboliske hændelser betinget af disse produkter i forhold til produkter indeholdende levonorgestrel,
English: “The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).”
Danish: “Den øgede risiko for venøs tromboemboli post partum bør tages i betragtning ved genoptagelse af behandling med [særnavn] (se pkt.
English: The CHMP considered the below PRAC recommendation dated 10 October 2013 with regards to combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol.
Danish: CHMP har gennemgået PRAC's anbefaling af 10. oktober 2013 om kombinerede hormonale kontraceptiva indeholdende chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat eller nomegestrol.
English: The PRAC confirmed the known risk of thromboembolism of combined hormonal contraceptive containing medicinal products, and recommended clear labelling of symptoms of thromboembolic events, as well as the risk factors for thromboembolic events.
Danish: PRAC fastslog den kendte risiko for tromboemboli ved lægemidler indeholdende kombinerede hormonale kontraceptiva og anbefalede tydelig mærkning med symptomerne på og risikofaktorerne for tromboemboliske hændelser,
English: However, the PRAC recommended routine risk minimisation measures, including a strengthening of the wording of the product information to reflect the current knowledge of risks (incidence rate) as well as symptoms for VTE and ATE and clarifying the situations for which these products are contraindicated.
Danish: PRAC anbefalede imidlertid rutinemæssige risikominimeringsforanstaltninger, herunder skærpelse og af ordlyden af produktoplysningerne, således at de afspejler den nuværende viden om risiciene (forekomsten) og symptomerne på venøs tromboemboli og arteriel tromboemboli, og præcisering af de situationer, hvor produkterne er kontraindiceret.
English: • The estimated incidence of risk is lowest with the CHCs containing the progestogens levonorgestrel, norgestimate and norethisterone: it is estimated that each year there will be between 5 and 7 cases of VTE per 10,000 women who use these medicines.
Danish: • den skønnede risiko er lavest med kombinerede hormonale kontraceptiva indeholdende progestogenerne levonorgestrel, norgestimat og norethisteron: Hvert år skønnes der at ville forekomme mellem 5 og 7 tilfælde af venøs tromboemboli per 10 000 kvinder, der anvender disse lægemidler.
English: The PRAC was requested to give a recommendation on whether the indication of medicinal products containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norelgestromin, norgestimate or nomegestrol combined with an oestrogen (ethinylestradiol or estradiol) should be restricted and/or any other regulatory measure(s) taken.
Danish: PRAC blev anmodet om at fremsætte en anbefaling for, om indikationen for lægemidler indeholdende chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden, norelgestromin, norgestimat eller nomegestrol kombineret med et østrogen (ethinylestradiol eller estradiol) burde begrænses, og/eller der burde træffes andre forskriftsmæssige foranstaltninger.
English: • The PRAC considered that in view of the currently available safety data, the benefit-risk balance of combined hormonal contraceptives is favourable, subject to restrictions, warnings and other changes to the product information.
Danish: • på baggrund af de foreliggende sikkerhedsdata fandt PRAC, at benefit/risk-forholdet er positivt for kombinerede hormonale kontraceptiva under forudsætning af begrænsninger, advarsler og andre ændringer af produktinformationen.