FrancophonIA/ELRC3.0 huggingface dataset:
English: The cats should be revaccinated every year.
Danish: Katten skal revaccineres hvert år.
English: The marketing authorisation was renewed on 18 April 2005.
Danish: Denne tilladelse blev fornyet den 18. april 2005.
English: Immunity starts at the latest two weeks after the second injection and lasts for a year.
Danish: Immunitet opnås senest to uger efter den anden indsprøjtning og varer i et år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax FeLV to MERIAL on 13 April 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax FeLV til MERIAL den 13. april 2000.
English: Immunisation against FeLV sub-group A provides full protection against all three sub-groups of the virus: A, B and C.
Danish: Immunisering mod FeLV undergruppe A beskytter fuldstændigt mod alle tre undergrupper af viruset: A, B og C.
English: The antibodies will help to protect against the disease caused by the virus.
Danish: Antistofferne medvirker til at beskytte mod den sygdom, der forårsages af viruset.
English: In case of accidental self-injection seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREVAX FELV EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PUREVAX FELV EPAR - sammendrag for offentligheden
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to the FeLV.
Danish: Derefter vil dens immunsystem fremover kunne producere antistoffer hurtigere, når det møder FeLV.
English: The vaccine is used to prevent the symptoms of the disease and to prevent FeLV from remaining in the blood.
Danish: Vaccinen anvendes til at forebygge symptomerne på sygdommen og forhindre, at FeLV er til stede i blodet.
English: A 1 ml dose of Purevax FeLV is injected under the skin.
Danish: En dosis på 1 ml Purevax FeLV indsprøjtes under huden.
English: The canarypox viruses do not spread or multiply in the cat but they do produce proteins from the FeLV genes.
Danish: Canarypox-viruset kan ikke spredes eller formere sig i katten, men producerer alligevel proteiner fra FeLV-generne.
English: Vaccines work by priming the immune system (the body's natural defences) how to defend itself against diseases.
Danish: Vacciner virker ved at "lære" immunsystemet (organismens naturlige forsvar), hvordan det skal forsvare organismen mod sygdomme.
English: When a cat is given the vaccine, the immune system recognises the FeLV proteins as ‘foreign' and makes antibodies against them.
Danish: Når katten får vaccinen, opfatter dens immunsystem FeLV-proteinerne som "fremmede" og producerer antistoffer mod dem.
English: The effectiveness of Purevax FeLV has been studied in several trials in laboratory conditions where cats were vaccinated and infected with FeLV.
Danish: Virkningen af Purevax FeLV blev registreret i flere undersøgelser under laboratorieforhold, hvor kattene blev vaccineret og smittet med FeLV.
English: Purevax FeLV is a vaccine.
Danish: Purevax FeLV er en vaccine.
English: Purevax FeLV should not be used in pregnant cats.
Danish: Purevax FeLV bør ikke anvendes til drægtige katte.
English: The vaccinated kittens were housed for up to 28 weeks with a group of kittens who were infected with FeLV.
Danish: De vaccinerede killinger blev i indtil 28 uger anbragt sammen med en gruppe killinger, der var smittet med FeLV.
English: Other information about Purevax FeLV:
Danish: Andre oplysninger om Purevax FeLV:
English: Temporary lethargy (listlessness) and hyperthermia (increased body temperature) may occur for one day, exceptionally for two days.
Danish: Der kan forekomme forbigående sløvhed og temperaturforhøjelse i én dag, undtagelsesvis to dage.
English: Infection was seen from four weeks in non-vaccinated animals.
Danish: Hos de uvaccinerede dyr kunne smitte iagttages efter fire uger.
English: Purevax FeLV is a vaccine containing feline leukaemia virus (FeLV) recombinant canarypox virus (vCP97).
Danish: Purevax FeLV er en vaccine, der indeholder felint leukæmivirus (FeLV) rekombinant canarypox virus (vCP97).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax FeLV exceed the risks for active immunisation of cats eight weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease, and recommended that Purevax FeLV be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Purevax FeLV opvejer risiciene til vaccination af katte over otte uger mod felin leukæmi for at forebygge permanent tilstedeværelse af virus i blodet og kliniske tegn på den tilknyttede sygdom, og anbefalede udstedelse af markedsføringstilladelse for Purevax FeLV.
English: In all trials, the main measure of effectiveness was the presence of antibodies against the virus and infectious FeLV in the vaccinated kittens' blood.
Danish: I alle undersøgelserne blev virkningen hovedsagelig bedømt på tilstedeværelsen af antistoffer mod viruset og smittefarligt FeLV i blodet på de vaccinerede killinger.
English: Purevax FeLV is used to vaccinate cats from the age of eight weeks against feline leukaemia, an illness affecting the immune system caused by a type of virus known as a retrovirus.
Danish: Purevax FeLV anvendes til at vaccinere katte over otte uger mod felin leukæmi, en sygdom i immunsystemet, der skyldes en type virus, der kaldes retrovirus.
English: A temporary small nodule (hard lump) may appear at the site of injection.
Danish: Der kan midlertidigt dannes en lille knude på injektionsstedet.
English: In the field, efficacy has been studied in one main study of kittens aged eight weeks or older, in which the effects of Purevax FeLV were compared with those of another vaccine against FeLV.
Danish: I marken blev der udført én hovedundersøgelse med killinger på over otte uger, hvor virkningerne af Purevax FeLV blev sammenlignet med virkningerne af en anden vaccine mod FeLV.
English: The first injection should be given in cats aged at least eight weeks, with a second injection three to five weeks later.
Danish: Ved den første indsprøjtning skal katten være mindst otte uger gammel.
English: Purevax FeLV vaccine provided protection against FeLV infection.
Danish: Purevax FeLV vaccine beskyttede mod smitte med FeLV.
English: For a full list of all side effects reported with Purevax FeLV, see the Package Leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Purevax FeLV fremgår af indlægssedlen.
English: Purevax FeLV is presented as a suspension for injection.
Danish: Purevax FeLV leveres som injektionsvæske (suspension).
English: Why has Purevax FeLV been approved?
Danish: Hvorfor blev Purevax FeLV godkendt?
English: What is the risk associated with Purevax FeLV?
Danish: Hvilken risiko er der forbundet med Purevax FeLV?
English: The first evidence of FeLV infection occurred after six weeks in only a few of the kittens vaccinated with Purevax FeLV.
Danish: Efter seks uger var der kun begyndende tegn på smitte med FeLV hos få af de killinger, der var vaccineret med Purevax FeLV.
English: Purevax FeLV contains genes from the FeLV sub-group A called env and gag which have been inserted into another vector (carrier) virus called canarypox using ‘recombinant DNA technology'.
Danish: Purevax FeLV indeholder generne env og gag fra FeLV undergruppe A. Disse gener er ved rekombinant dnateknologi blevet indsat i en anden vektor, dvs. et bærervirus.
English: What is Purevax FeLV?
Danish: Hvad er Purevax FeLV?
English: How has Purevax FeLV been studied?
Danish: Hvordan blev Purevax FeLV undersøgt?
English: What is Purevax FeLV used for?
Danish: Hvad anvendes Purevax FeLV til?
English: How does Purevax FeLV work?
Danish: Hvordan virker Purevax FeLV?
English: What benefit has Purevax FeLV shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Purevax FeLV?
English: less frequently.
Danish: mindre hyppigt.
English: to you and your child.
Danish: indebærer for Dem og Deres barn.
English: contains lactose later in this section).
Danish: indeholder lactose” senere i dette afsnit).
English: - Risk management plan (RMP)
Danish: - Risikostyringsplan (RMP)
English: Date of first authorisation: 28 April 2017
Danish: Dato for første markedsføringstilladelse: 28. april 2017
English: to older people.
Danish: til ældre mennesker.
English: with food and drink
Danish: sammen med mad og drikke
English: with other antiretroviral medicines.
Danish: sammen med andre antiretrovirale lægemidler.
English: is not for use in children under 12 years of age.
Danish: må ikke anvendes til børn under 12 år.
English: Adults: one tablet each day, where possible, with food.
Danish: Voksne: En tablet om dagen, så vidt muligt sammen med mad.
English: Transmission of HIV:
Danish: Overførsel af HIV:
English: has not been studied in patients over 65 years of age.
Danish: er ikke blevet undersøgt hos patienter over 65 år.
English: contains sodium".
Danish: indeholder natrium“.
English: may be considered during pregnancy, if necessary.
Danish: derfor overvejes under graviditet.
English: should only be used in individuals with creatinine clearance (CrCl) <80 mL/min if the potential benefits are considered to outweigh the potential risks.
Danish: bør kun anvendes hos personer med kreatininclearance (CrCl) <80 ml/min, hvis de potentielle fordele anses for at opveje de potentielle risici.
English: at a prolonged dosing interval.
Danish: med et forlænget doseringsinterval.
English: is administered with a third nucleoside analogue.
Danish: administreres sammen med en tredje nukleosidanalog.
English: should not be given to adolescents with existing kidney problems.
Danish: bør ikke anvendes til unge med eksisterende nyreproblemer.
English: - It is also used to treat HIV in adolescents aged 12 to less than 18 years who weigh at least 35 kg, and who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
Danish: Det bruges også til at behandle HIV hos unge i alderen fra 12 til under 18 år, som vejer mindst 35 kg, og som allerede er blevet behandlet med andre HIV-lægemidler, som ikke længere er effektive, eller som har forårsaget bivirkninger.
English: during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: under Deres graviditet, kan lægen anmode om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: may affect your kidneys.
Danish: kan have indvirkning på Deres nyrer.
English: Stopping tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
Danish: Hvis De stopper med at tage tabletterne kan det nedsætte effektiviteten af den behandling mod hiv, som Deres læge anbefaler.
English: should also be considered in case of progressive decline of renal function when no other cause has been identified.
Danish: bør også overvejes i tilfælde af progredierende nedsat nyrefunktion, når ingen anden årsag er blevet påvist.
English: or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Danish: eller anden antiretroviral behandling, kan fortsætte med at udvikle opportunistiske infektioner og andre komplikationer som følge af hiv-infektion og bør derfor forblive under nøje klinisk observation af læger, som har erfaring med behandling af patienter med hiv-associerede sygdomme.
English: Moreover, the reversibility of renal toxicity cannot be fully ascertained.
Danish: Reversibiliteten af nefrotoksicitet kan desuden ikke fastlægges fuldt ud.
English: should be initiated by a physician experienced in the management of HIV infection.
Danish: skal initieres af en læge med erfaring i behandlingen af hiv-infektion.
English: can cause dizziness.
Danish: kan forårsage svimmelhed.
English: Shelf life after first opening of the bottle: 2 months.
Danish: Holdbarhed efter første åbning af tabletbeholderen: 2 måneder.
English: is missed by more than 12 hours and it is almost time for the next dose, the missed dose should not be taken and the usual dosing schedule should be resumed.
Danish: i mere end 12 timer, og det næsten er tid til næste dosis, skal den glemte dosis ikke tages, men den normale doseringsplan genoptages.
English: should always be used combined with other medicines to treat HIV infection.
Danish: skal altid anvendes sammen med anden medicin til behandling af hiv-infektion.
English: to treat HIV
Danish: for at behandle hiv
English: - No virus analysed contained the K65R or K70E mutation.
Danish: Ingen analyseret virus indeholdt K65R- eller K70E-mutationen.
English: is used in patients with creatinine clearance < 60 mL/min, and renal function should be closely monitored.
Danish: anvendes til patienter med kreatininclearance < 60 ml/min, og nyrefunktionen bør monitoreres omhyggeligt.
English: is not recommended if you have severe kidney disease or are on dialysis.
Danish: anbefales ikke, hvis De lider af svære nyresygdomme eller er i dialyse.
English: Blisters OPA/Alu/PE+DES/ - Aluminium blisters.
Danish: OPA/Alu/PE+DES/ - Aluminium blistere.
English: for the treatment of HIV-1 infection, it is recommended that creatinine clearance is calculated in all individuals.
Danish: til behandling af hiv-1 infektion anbefales det at beregne kreatininclearance hos alle personer.
English: Adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet, once daily.
Danish: Voksne og unge i alderen 12 år og derover, der vejer mindst 35 kg: En tablet en gang dagligt.
English: with other medicines that can damage your kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including aminoglycosides (for bacterial infection) amphotericin B (for fungal infection) foscarnet (for viral infection) ganciclovir (for viral infection) pentamidine (for infections)
Danish: samtidig med andre lægemidler, som kan skade Deres nyrer: Det er specielt vigtigt at fortælle Deres læge, hvis De tager nogen af disse lægemidler, herunder aminoglykosider (mod bakterie-infektion) amphotericin B (mod svampeinfektion) foscarnet (mod virusinfektion)
English: is available also in bottles of 30 tablets, with a childresistant tamper evident plastic closure with integrated a silica gel desiccant, which helps to protect your tablets.
Danish: fås også i tabletbeholdere, der indeholder 30 tabletter med et børnesikret og forseglet låg af plastik med et integreret silicagel-tørremiddel, som hjælper med at beskytte Deres tabletter.
English: with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4 cell counts.
Danish: sammen med antiviral medicin, som indeholder didanosin, kan det øge indholdet af didanosin i blodet og reducere CD4-celletallet.
English: contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: indeholder lactose Hvis De har fået at vide, at De ikke tåler andre sukkerarter, skal De tale med Deres læge, før De tager denne medicin.
English: vancomycin (for bacterial infection) interleukin-2 (to treat cancer) cidofovir (for viral infection) non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
Danish: ganciclovir (mod virusinfektion) pentamidin (mod infektioner) vancomycin (mod bakterie-infektion) interleukin-2 (til behandling af kræft) cidofovir (mod virusinfektion) non-steroide antiinflammatoriske lægemidler (NSAID'er, til at lindre knogle- eller muskelsmerter)
English: with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Danish: sammen med lægemidler, der reducerer nyrefunktionen eller konkurrerer om aktiv tubulær sekretion (f.eks. cidofovir) øge serumkoncentrationerne af emtricitabin, tenofovir og/eller de samtidigt administrerede lægemidler.
English: Lamivudine and
Danish: Lamivudin og
English: 200 mg/245 mg film-coated tablets
Danish: 200 mg/245 mg filmovertrukne tabletter
English: is:
Danish: er:
English: Table 2: Interactions between the individual components of emtricitabine/tenofovir disoproxil and other medicinal products
Danish: Tabel 2: Interaktioner mellem de individuelle komponenter i emtricitabin/tenofovirdisoproxil og andre lægemidler
English: therapy in patients infected with HBV may be associated with severe acute exacerbations of hepatitis.
Danish: hos patienter, der er inficeret med HBV, kan være forbundet med svær, akut forværring af hepatitis.
English: HIV-1infected patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Danish: Hiv-1 inficerede patienter med eksisterende leverdysfunktion, herunder kronisk aktiv hepatitis, har en øget hyppighed af leverfunktionsabnormiteter under antiretroviral kombinationsbehandling (CART) og bør monitoreres i henhold til gældende praksis.
English: should not be administered concomitantly (see section 4.4).
Danish: må ikke administreres samtidigt (se pkt.
English: Renal function (creatinine clearance and serum phosphate) should be evaluated prior to treatment, and should be monitored during use as in adults (see above).
Danish: Nyrefunktionen (kreatininclearance og serumphosphat) skal evalueres før der startes på Emtricitabine/Tenofovir til behandling og den bør monitoreres under brugen på samme måde som hos voksne (se ovenfor).
English: 28 film-coated tablets: EU/1/17/1182/001 84 film-coated tablets: EU/1/17/1182/003
Danish: 28 filmovertrukne tabletter: EU/1/17/1182/001 84 filmovertrukne tabletter: EU/1/17/1182/003
English: in patients with creatinine clearance decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Danish: hos patienter, hvor kreatininclearance falder til < 50 ml/min eller serumphosphat til < 1,0 mg/dl (0,32 mmol/L).
English: and didanosine is not recommended (see section 4.4).
Danish: og didanosin anbefales ikke (se pkt.
English: During treatment for HIV there may be an increase in weight and in levels of blood lipids and glucose.
Danish: Under hiv-behandling kan der forekomme en stigning i legemsvægt og i et forhøjet indhold af lipider og glucose i blodet.
English: Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Danish: Studiet blev udført med yderligere voxilaprevir 100 mg for at opnå de forventede voxilaprevir-eksponeringer hos
English: contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Danish: indeholder natrium Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige ”natriumfri”.
English: The increased dose interval for emtricitabine/tenofovir disoproxil in HIV-1 infected patients with moderate renal impairment is expected to result in higher peak plasma concentrations and lower Cmin levels as compared to patients with normal renal function.
Danish: Det øgede dosisinterval for emtricitabin/tenofovirdisoproxil hos hIV-1-inficerede patienter med moderat nedsat nyrefunktion forventes at resultere i højere peak-plasmakoncentrationer og lavere Cminniveauer sammenlignet med patienter med normal nyrefunktion.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be lifethreatening.
Danish: Hos nogle patienter med fremskreden leversygdom eller cirrose bør behandlingen ikke ophøre, fordi det kan medføre forværring af Deres hepatitis, hvilket kan være livstruende.
English: is used to treat Human Immunodeficiency Virus 1 (HIV-1) infection in adults.
Danish: bruges til at behandle infektion forårsaget af humant immundefekt virus 1 (hiv 1-infektion) hos voksne.
English: Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Danish: Emtricitabintriphosphat og tenofovirdiphosphat hæmmer kompetitivt hiv 1-revers transkriptase, hvilket resulterer i dna-kædeblokering.
English: If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir disoproxil Krka d.d., contact your doctor or nearest emergency department for advice.
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Emtricitabine/Tenofovir disoproxil Krka d.d., skal De kontakte lægen eller den nærmeste skadestue for at få råd.
English: is not recommended in patients with severe renal impairment (creatinine clearance < 30 mL/min) and in patients who require haemodialysis since appropriate dose reductions cannot be achieved with the combination tablet (see sections 4.2 and 5.2).
Danish: anbefales ikke til patienter med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) og hos patienter, som skal have hæmodialyse, da de nødvendige dosisreduktioner ikke kan opnås med kombinationstabletten (se pkt.
English: treatment without talking to your doctor first.
Danish: uden først at tale med Deres læge.
English: (emtricitabine and tenofovir disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.
Danish: (emtricitabin og tenofovir-disoproxil) eller antiviral medicin, som indeholder tenofovir-alafenamid, lamivudin eller adefovir-dipivoxil.
English: is coadministered with an NSAID, renal function should be monitored adequately.
Danish: administreres samtidig med et NSAID, skal nyrefunktionen monitoreres med passende intervaller.
English: Secondary efficacy analyses over 144 weeks included the proportion of patients with HIV-1 RNA concentrations < 400 or < 50 copies/mL, and change from baseline in CD4 cell count.
Danish: Sekundære virkningsanalyser i løbet af de 144 uger omfattede andelen af patienter med hiv 1-rna-koncentrationer < 400 eller < 50 kopier/mL og en ændring i CD4-celletallet fra baseline.
English: - That a multidisciplinary approach is recommended for the management of paediatric patients - That there is an increased risk of renal disease in HIV infected patients associated with tenofovir disoproxil-containing products such as Emtricitabine/Tenofovir disoproxil Krka d.d.
Danish: - At der anbefales en multidisciplinær tilgang til behandling af pædiatriske patienter - At der er en øget risiko for nyresygdom hos HIV-inficerede patienter ved præparater, der indeholder tenofovirdisoproxil, såsom Emtricitabine/Tenofovir disoproxil Krka d.d.
English: should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Danish: bør undgås ved samtidig eller nylig brug af et nefrotoksisk lægemiddel.
English: can be administered in place of emtricitabine and tenofovir disoproxil used separately at the same doses.
Danish: kan administreres i stedet for emtricitabin og tenofovirdisoproxil anvendt hver for sig med samme doser.
English: is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1).
Danish: er indiceret i antiretroviral kombinationsbehandling af hiv1-inficerede voksne (se pkt.
English: should not be administered concomitantly with adefovir dipivoxil.
Danish: bør ikke administreres samtidig med adefovirdipivoxil.
English: contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige ”natriumfri”.