FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Eravac (which may affect more than 1 in 10 rabbits) are a shortlived increase in body temperature to slightly above 40 ºC, which may occur between two or three days after vaccination, and nodules or swellings (less than 2 cm in size) at the injection site.
Danish: De hyppigste bivirkninger ved Eravac (som kan optræde hos mere end 1 ud af 10 kaniner) er en kortvarig stigning i kropstemperaturen til lidt over 40 ºC, som kan opstå to-tre dage efter vaccinationen, samt knuder og hævelser (på under 2 cm) på injektionsstedet.
English: What are the risks associated with Eravac?
Danish: Hvilke risici er der forbundet med Eravac?
English: If someone is accidentally injected with this product, they must seek medical attention immediately even if only a very small amount is injected.
Danish: Ved utilsigtet selvinjektion skal der straks søges lægehjælp, selvom den injicerede mængde er meget lille.
English: In the future if rabbits come into contact with rabbit haemorrhagic disease type 2 virus, these antibodies, together with other components of the immune system, will be able to destroy the virus and help protect against the disease.
Danish: Hvis kaninen senere kommer i kontakt med hæmoragisk sygdom type 2virusset, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at ødelægge virusset og hjælpe med at beskytte mod sygdommen.
English: RHD type 2 virus differs from the classic form of RHD virus since the course of disease is more prolonged, death occurs later and over a longer period and is more severe in young rabbits.
Danish: RHD type 2-virus adskiller sig fra det klassiske RHD-virus ved, at sygdomsforløbet er længere, døden indtræffer senere og tager længere tid, og sygdommen forekommer i sværere grad hos unge kaniner.
English: Other information about Eravac?
Danish: Andre oplysninger om Eravac
English: When it is given to rabbits, the immune system recognises the virus in the vaccine as ‘foreign' and makes antibodies against it.
Danish: Når Eravac gives til kaniner, registrerer dyrenes immunsystem virusset i vaccinen som "fremmed" og reagerer ved at danne antistoffer mod det.
English: Eravac is available as an injection and can only be obtained with a prescription.
Danish: Eravac fås som en injektionsvæske og udleveres kun på recept.
English: Eravac is a veterinary vaccine used in rabbits to reduce death due to the rabbit haemorrhagic disease (RHD), caused by the variant of RHD virus called RHD type 2 (RHDV2).
Danish: Eravac er en veterinærvaccine, som gives til kaniner for at reducere antallet af dødsfald forårsaget af viral hæmoragisk sygdom hos kaniner (RHD (rabbit haemorrhagic disease)) forårsaget af den variant af RHD-virusset, som kaldes RHD type 2 (RHD2).
English: How is Eravac used?
Danish: Hvordan anvendes Eravac?
English: What benefits of Eravac have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Eravac?
English: In a later laboratory study involving 48 rabbits, 95% of Eravac vaccinated rabbits survived, compared to 65% of rabbits given placebo, following artificial infection with RHDV2 at 12 months after vaccination.
Danish: I et senere laboratoriestudie med 48 kaniner overlevede 95 % af de kaniner, der var vaccineret med Eravac, sammenlignet med 65 % af de kaniner, der fik placebo, efter kunstig infektion med RHDV2 12 måneder efter vaccinationen.
English: In the third study all Eravac-vaccinated rabbits survived, compared with less than 70% of the rabbits in the control group, when rabbits were artificially infected with RHDV2 nine months after vaccination.
Danish: I det tredje studie overlevede alle de kaniner, der var vaccineret med Eravac mens overlevelsesraten i kontrolgruppen var under 70%, når kaninerne blev kunstigt smittet med RHDV2 ni måneder efter vaccinationen.
English: Eravac contains rabbit haemorrhagic disease type 2 virus (RHDV2) strain V-1037, which has been inactivated so it cannot cause the disease.
Danish: Eravac indeholder RHD type 2-virus (RHDV2), stamme V-1037, i en inaktiveret form, så det ikke kan forårsage sygdom.
English: Eravac contains inactivated rabbit haemorrhagic disease type 2 virus, strain V-1037, as the active substance.
Danish: Eravac indeholder inaktiveret RHD type 2-virus, stamme V-1037, som det aktive stof.
English: Eravac (rabbit haemorrhagic disease vaccine, inactivated)
Danish: Eravac (vaccine mod viral hæmoragisk sygdom hos kaniner, inaktiveret)
English: In one study all Eravac-vaccinated rabbits survived, compared with a 37% survival rate in the group that received the placebo vaccine.
Danish: I det første studie overlevede alle de kaniner, der var vaccineret med Eravac, mens overlevelsesraten hos den gruppe, der fik placebovaccinen, var på 37 %.
English: In the second study survival of Eravac-vaccinated rabbits was 93% compared with 50% for rabbits given placebo.
Danish: I det andet studie havde de kaniner, der var vaccineret med Eravac, en overlevelsesrate på 93 %, mens overlevelsesraten i placebogruppen var på 50 %.
English: How does Eravac work?
Danish: Hvordan virker Eravac?
English: The injection should not be repeated.
Danish: Injektionen bør ikke gentages.
English: Forceris may be harmful for the unborn child.
Danish: Forceris kan være skadeligt for ufødte børn.
English: The withdrawal period for meat from pigs treated with Forceris is 70 days.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Forceris, er 70 dage.
English: Hands should be washed after using the medicine.
Danish: Der bør vaskes hænder efter brugen af lægemidlet.
English: Other information about Forceris
Danish: Andre oplysninger om Forceris
English: Further information on Forceris can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/forceris.
Danish: Yderligere oplysninger om Forceris findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/forceris.
English: Forceris is a veterinary medicine.
Danish: Forceris er et lægemiddel til dyr.
English: Forceris received a marketing authorisation valid throughout the EU on 23 April 2019.
Danish: Forceris fik en markedsføringstilladelse med gyldighed i hele EU den 23/04/2019.
English: Excess iron is stored mainly in the liver.
Danish: Overskydende jern lagres hovedsageligt i leveren.
English: What is Forceris and what is it used for?
Danish: Hvad er Forceris, og hvad anvendes det til?
English: As a result it is able to kill the parasites at all stages of their development and prevent the symptoms of coccidiosis and the spread of infection.
Danish: Det kan derfor dræbe parasitterne på alle stadier i deres udvikling og forebygge symptomerne på coccidiose og spredning af infektionen.
English: The European Medicines Agency decided that Forceris' benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Forceris opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: It is given as a single injection into the muscle behind the ear of piglets between 24 and 96 hours old.
Danish: Det gives som en enkelt injektion i musklen bag øret på smågrisene, når de er mellem 24 og 96 timer gamle.
English: Why is Forceris authorised in the EU?
Danish: Hvorfor blev Forceris godkendt i EU?
English: An overview of Forceris and why it is authorised in the EU
Danish: Oversigt over Forceris, og hvorfor det er godkendt i EU
English: Pregnant women and women intending to conceive should avoid contact with the medicine, especially accidental self-injection.
Danish: Gravide og kvinder, der planlægger at blive gravide, bør undgå kontakt med lægemidlet, navnlig utilsigtet selvinjektion.
English: Skin and eye contact with Forceris can cause irritation and should be avoided.
Danish: Hud- og øjenkontakt med Forceris kan fremkalde irritation og bør undgås.
English: Toltrazuril is an antiparastic medicine which interferes with the enzymes needed by coccidia parasites to produce energy.
Danish: Toltrazuril er et antiparasitlægemiddel, der påvirker de enzymer, der er nødvendige for, at coccidiaparasitterne kan producere energi.
English: Care should be taken to avoid accidental self-injection, which may cause local reactions such as irritation, granulomas, or severe anaphylactic (allergic) reactions in sensitive people.
Danish: Der bør udvises forsigtighed for at undgå utilsigtet selvinjektion, som kan give lokale reaktioner såsom irritation, granulomer eller svære anafylaktiske (allergiske) reaktioner hos følsomme personer.
English: What are the risks associated with Forceris?
Danish: Hvilke risici er der forbundet med Forceris?
English: People who are hypersensitive (allergic) to iron compounds or toltrazuril should avoid contact with Forceris.
Danish: Personer, som er overfølsomme (allergiske) over for jernforbindelser eller toltrazuril, bør undgå kontakt med Forceris.
English: Following injection into the muscle, gleptoferron is absorbed and broken down to release iron for use and/or storage depending on the nutritional need of the piglet.
Danish: Efter injektion i musklen optages gleptoferron, og det nedbrydes og frigiver jern til brug og/eller lagring afhængigt af smågrisenes ernæringsmæssige behov.
English: Forceris must not be given to piglets suspected to have insufficient levels of vitamin E or selenium.
Danish: Forceris må ikke gives til smågrise, som formodes at have et for lavt indhold af E-vitamin eller selen.
English: For more information about using Forceris, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Forceris, kan du læse indlægssedlen eller kontakte din dyrlæge eller apoteket.
English: For the full list of side effects and restrictions of Forceris, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Forceris fremgår af indlægssedlen.
English: Forceris is available as an injection and can only be obtained with a prescription.
Danish: Forceris fås som en injektionsvæske og udleveres kun efter recept.
English: It is used in young piglets on farms which have been affected by the parasitic infection coccidiosis in the past to prevent diarrhoea caused by a new coccidiosis infection, to reduce spread of the infection through passage of oocysts (disease spores) in faeces, and at the same time to prevent iron deficiency anaemia due to lack of iron in the piglets' diet.
Danish: Det anvendes til unge smågrise på bedrifter, der tidligere har været ramt af parasitinfektionen coccidiose, til at forebygge diarré forårsaget af en ny coccidioseinfektion, begrænse spredningen af infektionen via udskillelse af oocyster (sygdomssporer) i fæces og samtidig forebygge jernmangelanæmi på grund af for lidt jern i smågrisenes kost.
English: What benefits of Forceris have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Forceris?
English: Iron is an essential nutrient needed to make haemoglobin to transport oxygen in the blood, as well as certain key enzymes, and may be lacking in the diet of piglets raised under intensive farming conditions.
Danish: Jern er et vigtigt næringsstof, der er nødvendigt for at danne hæmoglobin til transport af ilt i blodet og danne bestemte vigtige enzymer, og der kan mangle jern i den kost, som smågrise får ved intensiv opdræt.
English: The other active substance in Forceris, gleptoferron, is an iron-containing compound.
Danish: Det andet aktive stof i Forceris, gleptoferron, er en jernholdig forbindelse.
English: How is Forceris used?
Danish: Hvordan anvendes Forceris?
English: Forceris contains the active substances toltrazuril and gleptoferron (an iron-containing compound).
Danish: Forceris indeholder de aktive stoffer toltrazuril og gleptoferron (en jernholdig forbindelse).
English: In a field study performed in 3 EU countries and involving over 1,500 piglets, a single intramuscular injection of Forceris given at 24 to 96 hours of age was effective in preventing iron deficiency anaemia,
Danish: I en feltundersøgelse, som blev udført i tre EU-lande med mere end 1.500 smågrise, var én enkelt intramuskulær injektion af Forceris, når smågrisene var 24-96 timer gamle, effektivt til at forebygge jernmangelanæmi, nedsætte oocystudskillelsen og forebygge diarré i forbindelse med coccidiose forårsaget af coccidiaparasitten Cystoisospora suissammenlignet med jern givet alene (som gleptoferron) den første dag efter fødslen.
English: How does Forceris work?
Danish: Hvordan virker Forceris?
English: 12 August 2013
Danish: Den 12. august 2013
English: The Czech Republic is the reference Member State and Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain and the United Kingdom are concerned Member States.
Danish: Tjekkiet er referencemedlemsstat, og Østrig, Danmark, Frankrig, Tyskland, Irland, Italien, Nederlandene, Portugal, Spanien og Det Forenede Kongerige er berørte medlemsstater.
English: The opinion was converted into a Decision by the European Commission on 12 August 2013.
Danish: Udtalelsen blev den 12. august 2013 omarbejdet til en beslutning af Europa-Kommissionen.
English: The decentralised procedure started on 29 November 2010.
Danish: Den decentrale procedure blev indledt den 29. november 2010.
English: International non-proprietary name (INN): amoxicillin and clavulanic acid
Danish: Internationalt fællesnavn (INN): amoxicillin og clavulansyre
English: Potential serious risks were identified during the decentralised procedure by the Netherlands and the United Kingdom regarding the environmental safety of the product.
Danish: Under den decentrale procedure påpegede Nederlandene og Det Forenede Kongerige potentielle alvorlige risici vedrørende produktets miljøsikkerhed.
English: Written explanations were provided by the applicant on 11 September 2012 and 6 February 2013.
Danish: Ansøgeren fremsendte skriftlige redegørelser den 11. september 2012 og den 6. februar 2013.
English: The Committee appointed Mr J. Schefferlie as rapporteur and Dr J. Bureš as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis hr. G. J. Schefferlie og dr. J. Bureš.
English: and gastrointestinal infections caused by Clostridium spp., E. coli and Salmonella spp.
Danish: og Streptococcus spp., samt gastrointestinale infektioner forårsaget af Clostridium spp., E. coli og Salmonella spp.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 2 May 2012.
Danish: På dag 210 var disse spørgsmål fortsat uafklarede, hvorfor sagen den 2. maj 2012 i henhold til artikel 33, stk. 1, i direktiv 2001/82/EF blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - veterinær (CMD(v)).
English: On 11 July 2012, the reference Member State, the Czech Republic, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Danish: Den 11. juli 2012 underrettede referencemedlemsstaten, Tjekkiet, Det Europæiske Lægemiddelagentur om, at CMD(v) ikke havde været i stand til at nå til enighed vedrørende produktet, og indbragte sagen for CVMP i medfør af artikel 33, stk. 4, i direktiv 2001/82/EF.
English: STRENZEN 500/125 mg/g powder for use in drinking water for pigs contains amoxicillin and clavulanic acid as active ingredients and is intended for use in pigs for the treatment of respiratory tract infections caused by microorganisms susceptible to the combination amoxicillin/clavulanic acid i.e. Actinobacillus pleuropneumoniae, Pasteurella spp, Streptococcus spp.
Danish: STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, indeholder amoxicillin og clavulansyre som aktive indholdsstoffer og er bestemt til behandling af luftvejsinfektioner hos svin forårsaget af mikroorganismer, der er følsomme for kombinationen af amoxicillin og clavulansyre, dvs. Actinobacillus pleuropneumoniae, Pasteurella spp.
English: Oral explanations were given on 9 April 2013.
Danish: Mundtlige redegørelser blev afgivet den 9. april
English: This is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Amoksiklav 500/125 mg/g powder for use in drinking water authorised in the Czech Republic (MA No. 96/069/98-C).
Danish: Ansøgningen er en generisk ansøgning i henhold til artikel 13, stk. 1, i direktiv 2001/82/EF, som ændret, der henviser til referenceproduktet Amoksiklav, pulver til opløsning i drikkevand, 500/125 mg/g, som er godkendt i Tjekkiet (nr. 96/069/98-C).
English: The applicant, Novartis Animal Health Inc., submitted an application for a decentralised procedure for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names.
Danish: Ansøgeren, Novartis Animal Health Inc., indgav en ansøgning via den decentrale procedure for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g til svin, og relaterede navne.
English: Opinion following an Article 33(4)0F referral for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names EMA/325274/2013
Danish: Udtalelse efter en indbringelse i henhold til artikel 33, stk. 40F, for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, og relaterede navne EMA/325274/2013
English: Therefore, the Committee adopted by consensus a positive opinion on 10 April 2013 recommending the granting of a marketing authorisation for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names.
Danish: Den 10. april 2013 vedtog udvalget derfor en positiv udtalelse og anbefalede udstedelse af markedsføringstilladelse for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, og relaterede navne.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of STRENZEN 500/125 mg/g powder for use in drinking water for pigs is positive.
Danish: Efter vurdering af de foreliggende data fandt CVMP, at benefit/risk-forholdet for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, er positivt.
English: Opinion following an Article 33(4)1 referral for STRENZEN 500/125 mg/g powder for use in drinking water for pigs and associated names
Danish: Udtalelse efter en indbringelse i henhold til artikel 33, stk. 41, for STRENZEN, pulver til opløsning i drikkevand, 500/125 mg/g, til svin, og relaterede navne
English: Wash your hands before opening the pack
Danish: Vask hænder, før du åbner pakningen.
English: Tell your doctor as soon as possible.
Danish: Fortæl det hurtigst muligt til lægen.
English: The required dose is determined using the following formula:
Danish: Den påkrævede dosis bestemmes ved hjælp af den følgende formel:
English: Elderly There is limited experience in patients ≥65 years.
Danish: Der er begrænset erfaring hos patienter ≥65 år.
English: The following side effects may occur with this medicine.
Danish: De følgende bivirkninger kan forekomme med denne medicin.
English: None of these patients developed inhibitors.
Danish: Ingen af disse patienter udviklede inhibitorer.
English: Administration (Intravenous injection):
Danish: Administration (intravenøs injektion):
English: Your doctor may change your recommended injection rate to make it more comfortable for you.
Danish: Din læge kan ændre din anbefalede injektionshastighed for at gøre det mere behageligt for dig.
English: Take your dose as soon as you remember and then resume your normal dosing schedule.
Danish: Tag din dosis så snart du husker på det, og vend derefter tilbage til dit normale doseringsprogram.
English: The time to peak activity is not expected to be delayed.
Danish: Tiden til maksimal aktivitet forventes ikke at være forsinket.
English: Preparation:
Danish: Tilberedning:
English: How often you need an injection will depend on how well ELOCTA is working for you.
Danish: Hvor ofte du behøver en injektion afhænger af, hvor godt ELOCTA virker på dig.
English: These differences should be taken into account when dosing.
Danish: Disse forskelle skal overvejes ved dosering.
English: The rate of administration should be determined by the patient's comfort level and should not exceed 10 mL/min.
Danish: Administrationshastigheden bør fastlægges ved patientens komfortniveau, og den bør ikke overstige 10 ml/min.
English: Pack size of 1.
Danish: Pakningsstørrelse på 1.
English: Study I*
Danish: Studie I*
English: Do not use external heat.
Danish: Ekstern varme må ikke anvendes.
English: No symptoms of overdose have been reported.
Danish: Der er ikke rapporteret om symptomer af overdosering.
English: From a microbiological point of view, the product should be used immediately after reconstitution.
Danish: Fra et mikrobiologisk synspunkt bør præparatet anvendes umiddelbart efter rekonstitution.
English: SE-112 76 Stockholm Sweden
Danish: SE-112 76 Stockholm Sverige
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke straks anvendes er opbevaringstiderne under anvendelse og forholdene før anvendelse brugerens ansvar.
English: Check the name and strength of the package, to make sure it contains the correct medicine.
Danish: Kontroller navn og styrke på pakningen, så du er sikker på, at det indeholder den korrekte medicin.
English: QR code to be included+ http://www.elocta-instructions.com
Danish: QR-kode skal inkluderes+ http://www.elocta-instructions.com
English: EXP Use within 6 hours after reconstitution.
Danish: EXP Anvendes inden for 6 timer efter rekonstitution.
English: 12 to <18 years
Danish: 12 til <18 år
English: The specific activity of ELOCTA is 4000-10200 IU/mg protein.
Danish: Den specifikke aktivitet for ELOCTA er 4000-10200 IU/mg protein.
English: • There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ELOCTA.
Danish: • Der er en lille risiko for, at du kan opleve en anafylaktisk reaktion (en alvorlig, pludselig allergisk reaktion) over for ELOCTA.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Danish: Hvis sådanne inhibitorer forekommer, vil tilstanden manifestere sig som utilstrækkeligt klinisk respons.
English: Paediatric population The listed warnings and precautions apply both to adults, children and adolescents.
Danish: Pædiatrisk population De angivne advarsler og forsigtighedsregler gælder for både voksne, børn og unge.
English: Frequency of doses (hours)/ Duration of therapy (days)
Danish: Dosishyppighed (timer)/ Behandlingsvarighed (dage)
English: Study II
Danish: Studie II
English: ELOCTA is used to replace the missing or deficient factor VIII.
Danish: ELOCTA anvendes til at erstatte manglende eller defekt faktor VIII.
English: ELOCTA can be used for all age groups.
Danish: ELOCTA kan anvendes til alle aldersgrupper.
English: If severe, sudden allergic reactions (anaphylactic reaction) occur, the injection must be stopped immediately.
Danish: Hvis der opstår alvorlige, pludselige allergiske reaktioner (anafylaktisk reaktion), skal injektionen straks stoppes.
English: Studies to investigate genotoxicity, carcinogenicity, toxicity to reproduction or embryo-foetal development have not been conducted.
Danish: Studier undersøgende genotoksicitet, karcinogenicitet, reproduktionstoksicitet eller embryoføtal udvikling er ikke udført.
English: Rarely, inhibitors may develop after the first 100 exposure days.
Danish: I sjældne tilfælde kan der udvikles inhibitorer efter de første 100 eksponeringsdage.
English: 79.2 % of first injections were rated as excellent or good by the patients.
Danish: 79,2 % af de første injektioner blev vurderet som rigtigt gode eller gode af patienterne.
English: Dose based on bodyweight may require adjustment in underweight and overweight patients.
Danish: Dosis baseret på legemsvægt kan kræve justering hos undervægtige og overvægtige patienter.