FrancophonIA/ELRC3.0 huggingface dataset:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
Danish: Hvis selv-injektion opstår ved et uheld, bør der øjeblikkeligt søges læge og lægen informeres om at selv-injektion med en levende chlamydia vaccine er sket.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against Chlamydophila felis infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Danish: Aktiv immunisering af katte, der er 8 uger eller ældre: - mod felin viral rhinotracheitis for at reducere kliniske tegn, - mod calicivirus infektion for at reducere kliniske tegn, - mod Chlamydophila felis infektion for at reducere kliniske tegn, - mod felin panleukopeni til forebyggelse af dødsfald og kliniske tegn, - mod leukæmi til forebyggelse af persistent viræmi og kliniske tegn på sygdommen.
English: Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Danish: Den feline leukæmi vaccinestamme er en rekombinant canarypox virus, der afgiver env og gag generne i FeLV-A. Under praktiske forhold er det kun subgruppe A, der er infektiøs, og immunisering over for subgruppe A giver fuld beskyttelse over for A, B og C. Efter inokulering afgiver virus beskyttende proteiner, men disse multipliceres ikke hos kat.
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the chlamydiosis and feline leukaemia components and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Danish: Revaccination: - den første revaccination skal foretages for alle komponenterne et år efter basisvaccinationen, - efterfølgende revaccinationer skal foretages: hvert år for chlamydiose og felin leukæmi komponenterne og med intervaller på op til tre år for rhinotracheitis, calicivirus og panleukopeni komponenterne.
English: In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
Danish: Hypertermi og letargi, der sommetider er forbundet med halthed, er i meget sjældne tilfælde observeret én til tre uger efter revaccination af voksne katte.
English: Purevax RCPCh FeLV solvent
Danish: Purevax RCPCh FeLV solvens.
English: Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis, feline panleucopenia virus and feline leukaemia virus.
Danish: Stimulerer aktivt immuniteten over for felin rhinotracheitis herpesvirus, felin calicivirus, Chlamydophila felis, felin panleukopeni virus og felin leukæmivirus.
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens, which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Danish: Ved mistanke om tilstedeværelse af høje værdier af maternelle antistoffer over for rhinotracheitis, calicivirus, panleukopeni eller Chlamydophila komponenterne (fx hos 9-12 uger gamle killinger født af hunkatte, der var vaccineret før drægtighed og/eller med kendskab til eller mistanke om at have været udsat for de pågældende patogener), bør basisvaccination udsættes til killingerne er 12 uger gamle.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... >104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ....................................... >2,0 ELISA U. Svækket Chlamydophila felis (905 stamme) .................................................................... >103,0 EID502
English: Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate
Danish: Dinatriumphosphatdihydrat Magnesiumchloridhexahydrat Calciumchloriddihydrat
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the Chlamydophila felis and feline leukaemia components.
Danish: Varigheden af immunitet efter sidste revaccination er 3 år for rhinotracheitis, calicivirus og panleukopeni komponenterne og 1 år for Chlamydophila felis og felin leukæmi komponenterne.
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, chlamydiosis, feline panleucopenia and feline leukaemia.
Danish: Vaccine mod felin viral rhinotracheitis, felin calicivirus, chlamydiose, felin panleukopeni og felin leukæmi.
English: FeLV recombinant canarypox virus (vCP97)................................................................... ≥ 107.2 CCID50.
Danish: FeLV rekombinant canarypox virus (vCP97) ..................................................................... >107,2 CCID50
English: Gentamicin, at most .......................................................................................................................... 34 µg Solvent:
Danish: Gentamycin max…………………………………………………………….....................……………….….. 34 µg Solvens:
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Potassium chloride
Danish: Dinatriumhydrogenorthophosphat Monokaliumphosphat, vandfrit Kaliumchlorid
English: Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection.
Danish: Purevax RCPCh FeLV lyofilisat og solvens til injektionsvæske, suspension.
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Danish: Det er vist, at immuniteten indtræder 1 uge efter basisvaccination for rhinotracheitis, calicivirus, Chlamydophila felis og panleukopeni samt 2 uger efter basisvaccination for felin leukæmi.
English: Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Danish: 1 dosis (1 ml) indeholder: FHV (F2 stamme) ................................................................................................................>104,9 CCID50
English: FeLV recombinant canarypox virus (vCP97) .................................................................. ≥ 107.2 CCID501 1 cell culture infective dose 50%.
Danish: FeLV rekombinant canarypox virus (vCP97) ………………………………………… >107,2 CCID501 1 cellekultur infektiøs dosis 50%.
English: Purevax RCPCh FeLV lyophilisate and solvent for suspension for injection
Danish: Purevax RCPCh FeLV, lyofilisat og solvens til injektionsvæske, suspension.
English: FeLV recombinant canarypox virus (vCP97) .................................................................. ≥ 107.2 CCID501 1 cell culture infective dose 50%
Danish: FeLV rekombinant canarypox virus (vCP97) ………………………………………..… >107,2 CCID501 1 cellekultur infektiøs dosis 50%.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... >104,9 CCID501
English: The second injection is given three to four weeks later.
Danish: Den anden injektion gives tre til fire uger senere.
English: As the company had supplied additional information requested, the ‘exceptional circumstances' ended on 6 May 2013.
Danish: Efter at virksomheden havde forelagt de supplerende oplysninger, den var blevet anmodet om, blev de "særlige omstændigheder" ophævet den 6. maj 2013.
English: BTVPUR is a vaccine.
Danish: BTVPUR er en vaccine.
English: BTVPUR received a marketing authorisation valid throughout the EU on 12 April 2016.
Danish: BTVPUR fik en markedsføringstilladelse med gyldighed i hele EU den 12. april 2016.
English: Further information on BTVPUR can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere information om BTVPUR findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about BTVPUR:
Danish: Andre oplysninger om BTVPUR:
English: What is BTVPUR and what is it used for?
Danish: Hvad er BTVPUR, og hvad anvendes det til?
English: The withdrawal period for meat and milk from sheep and cattle treated with BTVPUR is ‘zero' days, which means that there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og mælk fra får og kvæg, der behandles med BTVPUR, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: There can also be a slight rise in body temperature, usually of no more than 1 °C, in the 24 hours following vaccination.
Danish: Der kan også forekomme en let forhøjelse af dyrets kropstemperatur, der normalt ikke overstiger 1 °C, inden for 24 timer efter vaccinationen.
English: BTVPUR is developed using data from the vaccine BTVPUR AlSap 1-8 originally authorised under ‘exceptional circumstances' on 17 December 2010 because limited information was available at the time of approval.
Danish: BTVPUR er udviklet ved hjælp af data fra vaccinen BTVPUR AlSap 1-8, der oprindeligt blev godkendt under "særlige omstændigheder" den 17. december 2010, da der på godkendelsestidspunktet kun forelå begrænsede oplysninger.
English: The European Medicines Agency decided that BTVPUR's benefits are greater that its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved BTVPUR opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Vaccination may be followed by a small local swelling at the injection site, which normally resolves within five weeks.
Danish: Vaccination kan forårsage en mindre lokal hævelse på injektionsstedet, som normalt forsvinder igen i løbet af fem uger.
English: Why is BTVPUR authorised in the EU?
Danish: Hvorfor blev BTVPUR godkendt i EU?
English: An overview of BTVPUR and why it is authorised in the EU
Danish: En oversigt over BTVPUR, og hvorfor det er godkendt i EU
English: In 2018 a fourth possible serotype was added still with one or two serotypes selected depending on the need.
Danish: I 2018 blev en fjerde mulig serotype tilføjet, stadig med udvælgelse af en eller to serotyper afhængigt af behovet.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) and reduce the signs of the disease.
Danish: Vaccinen anvendes til at forebygge viræmi (tilstedeværelse af virus i blodet) og reducere symptomerne på sygdommen.
English: What are the risks associated with BTVPUR?
Danish: Hvilke risici er der forbundet med BTVPUR?
English: For more information about using BTVPUR see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af BTVPUR, kan du læse indlægssedlen eller kontakte din dyrlæge eller apoteket.
English: The company also presented results from a series of studies conducted with vaccines of similar composition but including different serotypes from the ones in BTVPUR to provide supportive information that could be used to calculate the effectiveness of the vaccine.
Danish: Virksomheden fremlagde også resultaterne af en række studier gennemført med vacciner med tilsvarende sammensætning, men som omfattede andre serotyper end dem, der indgår i BTVPUR, for at fremskaffe yderligere informationer, som kunne anvendes til at beregne vaccinens virkning.
English: BTVPUR contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Danish: BTVPUR indeholder bluetonguevira, der er blevet inaktiveret, så de ikke kan fremkalde sygdommen.
English: In 2016 the CVMP considered that data submitted allowed BTVPUR AlSap 1-8 to convert to a BTVPUR vaccine based on three possible serotypes with one or two serotypes selected depending on the need.
Danish: I 2016 vurderede CVMP, at de indsendte data gjorde det muligt at ændre BTVPUR AlSap 1-8 til en BTVPURvaccine baseret på tre mulige serotyper med en eller to udvalgte serotyper, afhængigt af behovet.
English: Previously known as BTVPUR AlSap 1-8 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: Tidligere kendt som BTVPUR AlSap 1-8 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom fremover udsættes for bluetonguevirus, vil deres immunsystem kunne producere antistoffer hurtigere.
English: How is BTVPUR used?
Danish: Hvordan anvendes BTVPUR?
English: The first injection is given from one month of age in animals that have never been exposed to the disease, and from two-and-a-half months if the animal's mother is already immune to the disease and has bluetongue virus antibodies.
Danish: Den første injektion gives fra 1månedsalderen hos dyr, som ikke tidligere har været eksponeret for sygdommen, og fra 2,5månedsalderen, hvis dyret er født af et moderfår, der er immunt over for sygdommen, og som har antistoffer mod bluetonguevirus.
English: BTVPUR is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Danish: BTVPUR anvendes til får og kvæg for at beskytte dem mod sygdommen bluetongue, som er en infektion, der forårsages af bluetonguevirus, som overføres gennem mitter.
English: For a vaccine containing only bluetongue virus serotype 2 or 4 (or both together) in sheep, one injection is sufficient.
Danish: Med en vaccine til får, der kun indeholder bluetonguevirus af serotype 2 eller 4 (eller begge to), er én injektion tilstrækkelig.
English: The studies also showed that the vaccine can be used in pregnant and lactating sheep and cattle.
Danish: Undersøgelserne viste også, at vaccinen kan anvendes til at behandle drægtige og lakterende får.
English: What benefits of BTVPUR have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved BTVPUR?
English: Further laboratory studies were conducted in calves using a vaccine containing bluetongue serotype 2 and in sheep and calves using a vaccine containing bluetongue serotype 4.
Danish: Yderligere laboratoriestudier blev gennemført hos kalve med en vaccine indeholdende bluetongue-serotype 2 og hos får og kalve med en vaccine indeholdende bluetongue-serotype 4.
English: The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and prevents viraemia in animals from one month of age that are infected with bluetongue virus serotypes 1, 4 and 8.
Danish: Studierne viste, at vaccinen er sikker for får og kvæg, og at den reducerer symptomerne på sygdommen og forebygger viræmi hos dyr fra 1-månedsalderen, som er smittet med bluetonguevirus serotype 1, 4 og 8.
English: BTVPUR contains bluetongue virus of one or two types selected from serotypes 1, 2, 4 and 8.
Danish: BTVPUR indeholder bluetonguevirus af en eller to af serotyperne 1, 2, 4 og 8.
English: The studies also showed that the vaccine reduces the signs of the disease in sheep and prevents viraemia in sheep and cattle from one month of age that are infected with bluetongue virus serotype 2.
Danish: Studierne viste også, at vaccinen reducerer tegnene på sygdommen hos får og forebygger viræmi hos får og kvæg fra 1-månedsalderen, som er smittet med bluetonguevirusserotype 2.
English: (Bluetongue virus inactivated vaccine containing either serotype 1, 2, 4 or 8 or a combination of any two)
Danish: BTVPUR1 (vaccine indeholdende inaktiveret bluetonguevirus med enten serotype 1, 2, 4 eller 8 eller en kombination af to af disse)
English: The effectiveness of the vaccine was studied in laboratory studies using vaccines containing bluetongue serotype 1, bluetongue serotype 8, or both, in sheep and cattle of young age.
Danish: Vaccinens virkning blev undersøgt i fem hovedlaboratorieundersøgelser med vacciner, som indeholdt bluetongue serotype 1 og/eller bluetongue serotype 8 hos får og kvæg i en ung alder.
English: How does BTVPUR work?
Danish: Hvordan virker BTVPUR?
English: The variety (serotype) of the virus in the vaccine is selected depending on which serotypes are circulating and causing disease at the time of manufacture, so it may contain serotype 1, 2, 4 or 8 or a combination of any two of these.
Danish: Virusarten (serotypen) i vaccinen udvælges afhængigt af, hvilke serotyper der cirkulerer og forårsager sygdommen på fremstillingstidspunktet.
English: BTVPUR
Danish: Hvis dyrene
English: • At the request of the European Medicines Agency
Danish: • på anmodning fra det Det Europæiske Lægemiddelagentur
English: Adults from the age of 18 years:
Danish: Til voksne i alderen fra 18 år:
English: If this applies to you then your vaccination will be postponed until you are feeling better.
Danish: Hvis dette gælder for dig, vil vaccinationen blive udsat, indtil du har det bedre.
English: Special population:
Danish: Speciel population:
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du får denne vaccine, da den indeholder vigtige oplysninger.
English: If this is not treated it may lead to shock.
Danish: Hvis dette ikke bliver behandlet kan det medføre shock.
English: (see section 4.2 for information on paediatric use).
Danish: 4.2 for information om pædiatrisk anvendelse).
English: • They will give Prepandrix as an injection into a muscle.
Danish: • De vil give Prepandrix som en indsprøjtning i en muskel.
English: Information on outcomes from estimated more than 200,000 women who have been vaccinated during pregnancy is currently limited.
Danish: Oplysninger om forløbet fra et estimeret antal på mere end 200.000 kvinder, som blev vaccineret under graviditeten, er på nuværende tidpunkt begrænsede.
English: Frequencies are reported as:
Danish: Hyppigheder er rapporteret som:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/453/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/453/002
English: The vaccine contains an ‘adjuvant' AS03.
Danish: Vaccinen indeholder en “adjuvans” AS03.
English: There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study.
Danish: Der var ingen evidens for en øget risiko for et ugunstigt udfald blandt 100 graviditeter, som blev fulgt i et prospektivt klinisk studie.
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Danish: Almindelig (≥ 1/100 til < 1/10) Ikke almindelig (≥ 1/1.000 til < 1 /100) Sjælden ((≥ 1/10.000 til < 1/1.000) Meget sjælden (< 1/10.000)
English: For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om vaccinen, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades.
Danish: Pandemisk influenza er en type influenza, som opstår med mellemrum, der kan variere fra 10 år og til mange årtier.
English: Immunisation should be postponed in subjects with a severe febrile illness or acute infection.
Danish: Immunisering skal udsættes hos personer med alvorlig febril sygdom eller akut infektion.
English: A complete vaccination course with Prepandrix consists of two doses.
Danish: Et fuldstændigt vaccinationsprogram med Prepandrix består af to doser.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råd, før du får denne vaccine.
English: Do not have Prepandrix if any of the above apply to you.
Danish: Du må ikke få Prepandrix, hvis noget af ovennævnte passer på dig.
English: A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Prepandrix.
Danish: En mindre infektion, f.eks. forkølelse, er normalt ikke noget problem, men lægen vil afgøre, om du kan blive vaccineret med Prepandrix.
English: Your doctor or nurse will give you Prepandrix.
Danish: En læge eller sygeplejerske vil give dig Prepandrix.
English: Date of latest renewal: 28 November 2017
Danish: Dato for første markedsføringstilladelse: 14. maj 2008 Dato for seneste fornyelse: 28. november 2017
English: Prepandrix is not intended to be given at the same time as some other vaccines.
Danish: Prepandrix er ikke beregnet til at blive givet samtidig med visse andre vacciner.
English: An AS03-containing vaccine containing HA from H1N1v has been administered to women in each trimester of pregnancy.
Danish: En AS03-adjuveret vaccine indeholdende HA fra H1N1v blev administreret til gravide kvinder i hvert trimester.
English: Adjuvants are used to improve the body's response to the vaccine.
Danish: Adjuvans bruges for at få kroppen til at reagere bedre på vaccinen.
English: OTHER Storage (2ºC-8ºC), do not freeze, protect from light
Danish: ANDET Opbevaring (2 °C - 8 °C), må ikke fryses, beskyttes mod lys
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or foetal or neonatal toxicity.
Danish: Data fra gravide kvinder, vaccineret med forskellige inaktiverede, ikke-adjuverede sæson-vacciner tyder ikke på misdannelser eller føtal/neonatal toksicitet.
English: See sections 4.4, 4.8 and 5.1.
Danish: 4.4, 4.8 og 5.1.
English: The first two injections should be given at the elected date and the two other injections should preferably be given 3 weeks after.
Danish: De to første indsprøjtninger gives på en udvalgt dato, og de næste to indsprøjtninger skal gives tre uger efter.
English: The safety and efficacy of Prepandrix in children aged less than 3 years and in children and adolescents aged 10 to 17 years have not been established.
Danish: Prepandrix' sikkerhed og virkning hos børn i alderen under 3 år og hos børn og teenagere i alderen 1017 år er ikke klarlagt.