FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated.
Danish: Efter en boostervaccination givet 1 år efter endt basisvaccination er det vist, at varigheden af immunitet er 3 år.
English: The onset of immunity has been demonstrated from 3 weeks after the primary vaccination.
Danish: Indtræden af immunitet er vist fra 3 uger efter endt basisvaccination.
English: Buffered isotonic solution to
Danish: Isotonisk bufferopløsning
English: 10 µg
Danish: 10 mikrog.
English: Minimum quantity of purified p45 FeLV-envelope antigen
Danish: Aktivt stof: Minimumsmængde af renset p45-FeLV-envelope-antigen
English: LEUCOGEN suspension for injection for cats
Danish: LEUCOGEN injektionsvæske, suspension til katte
English: SK: Slovenská republika
Danish: SK: Slovenská republika VIRBAC
English: LV : Latvija
Danish: LV : Latvija VIRBAC
English: EXP {month/year} Once broached use immediately.
Danish: EXP {måneder/år} Skal anvendes umiddelbart efter anbrud/åbning.
English: PACKAGE LEAFLET: LEUCOGEN suspension for injection for cats
Danish: INDLÆGSSEDDEL: LEUCOGEN injektionsvæske, suspension til katte.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 10 or 50 vials
Danish: Æske med 10 eller 50 hætteglas
English: SI: Slovenija
Danish: SI: Slovenija VIRBAC
English: Marketing authorisation holder and manufacturer responsible for the batch release VIRBAC
Danish: Indehaver af markedsføringstilladelsen og fremstiller af batchfrigivelse:
English: RO : România
Danish: RO : România VIRBAC
English: This means that it contains the same active substances and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada.
Danish: Det betyder, at det indeholder de samme aktive stoffer og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Truvada.
English: In addition, it may be used in adolescents with HIV who are resistant to first-line treatments or who cannot take them because of side effects.
Danish: Desuden kan det anvendes til unge med hiv, som er resistente over for førstevalgsbehandlingerne, eller som ikke kan tage dem på grund af deres bivirkninger.
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden har også udført et studie, der har vist, at lægemidlet er "bioækvivalent" med referencelægemidlet.
English: Emtricitabine/Tenofovir disoproxil Krka received a marketing authorisation valid throughout the EU on 9 December 2016.
Danish: Emtricitabine/Tenofovir disoproxil Krka fik en markedsføringstilladelse med gyldighed i hele EU den 9. december 2016.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Krka.
Danish: Der er allerede udført studier af de aktive stoffers fordele og risici ved godkendt brug med referencelægemidlet, Truvada, og de behøver ikke blive gentaget for Emtricitabine/Tenofovir disoproxil Krka.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Krka has been shown to have comparable quality and to be bioequivalent to Truvada.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Emtricitabine/Tenofovir disoproxil Krka er af sammenlignelig kvalitet og er bioækvivalent med Truvada.
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Krka are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Emtricitabine/Tenofovir disoproxil Krka vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: Because Emtricitabine/Tenofovir disoproxil Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Emtricitabine/Tenofovir disoproxil Krka er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: Further information on Emtricitabine/Tenofovir disoproxil Krka can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/EmtricitabineTenofovir-disoproxil-Krka.
Danish: Yderligere information vedrørende Emtricitabine/Tenofovir disoproxil Krka findes på agenturets websted under: www.ema.europa.eu/medicines/human/EPAR/EmtricitabineTenofovir-disoproxil-Krka.
English: If patients need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
Danish: Hvis patienten skal stoppe med at tage emtricitabin eller tenofovir, eller dosis skal ændres, skal der tages lægemidler indeholdende emtricitabin eller tenofovirdisoproxil separat.
English: For more information about using Emtricitabine/Tenofovir disoproxil Krka, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Emtricitabine/Tenofovir disoproxil Krka, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Emtricitabine/Tenofovir disoproxil Krka does not cure HIV infection or AIDS, but it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Emtricitabine/Tenofovir disoproxil Krka helbreder ikke hivinfektion eller aids, men udsætter den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Danish: Emtricitabin og tenofovir ligner hinanden, idet de begge blokerer aktiviteten af revers transkriptase, som er et enzym, der produceres af hiv, for at virusset kan reproducere sig selv i de inficerede celler.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor.
Danish: Tenofovir er en nukleosidrevers transkriptasehæmmer.
English: As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Krka.
Danish: Som for alle lægemidler fremlagde virksomheden studier vedrørende kvaliteten af Emtricitabine/Tenofovir disoproxil Krka.
English: Emtricitabine/Tenofovir disoproxil Krka can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Emtricitabine/Tenofovir disoproxil Krka udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion.
English: As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Krka are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Emtricitabine/Tenofovir disoproxil Krka løbende overvåget.
English: Healthcare professionals will also receive a brochure and reminder card to hand out to individuals receiving the medicine for preexposure prophylaxis.
Danish: Sundhedspersonalet modtager også en brochure og et huskekort, som skal uddeles til personer, der tager lægemidlet som profylakse før eksponering.
English: Emtricitabine/Tenofovir disoproxil Krka is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Danish: Emtricitabine/Tenofovir disoproxil Krka anvendes også til forebyggelse af seksuelt overført hiv-1infektion hos voksne og unge, som har høj risiko for at blive smittet (profylakse før eksponering).
English: An overview of Emtricitabine/Tenofovir disoproxil Krka and why it is authorised in the EU
Danish: Oversigt over Emtricitabine/Tenofovir disoproxil Krka, og hvorfor det er godkendt i EU
English: For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Krka in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Danish: Ved profylakse før eksponering for hiv-1-infektion forventes Emtricitabine/Tenofovir disoproxil Krka i blodet at forhindre virusset i at formere og sprede sig fra infektionsstedet, hvis personen eksponeres for virusset.
English: Therefore, the Agency's view was that, as for Truvada, the benefit of Emtricitabine/Tenofovir disoproxil Krka outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Emtricitabine/Tenofovir disoproxil Krka opvejer de identificerede risici, som for Truvada, og at det kan godkendes til anvendelse i EU.
English: The company that markets Emtricitabine/Tenofovir disoproxil Krka will provide an information pack to doctors which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Krka on kidney function, and information about use for pre-exposure prophylaxis.
Danish: Virksomheden, der markedsfører Emtricitabine/Tenofovir disoproxil Krka, vil forsyne lægerne med en informationspakke, som omhandler de mulige skadelige virkninger af Emtricitabine/Tenofovir disoproxil Krka på nyrefunktionen samt information om brug i forbindelse med profylakse før eksponering.
English: Emtricitabine/Tenofovir disoproxil Krka is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil).
Danish: Emtricitabine/Tenofovir disoproxil Krka fås som tabletter (200 mg emtricitabin og 245 mg tenofovirdisoproxil).
English: What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Krka?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Emtricitabine/Tenofovir disoproxil Krka?
English: Emtricitabine/Tenofovir disoproxil Krka contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Danish: Emtricitabine/Tenofovir disoproxil Krka indeholder to aktive stoffer: emtricitabin, der er en nukleosidrevers transkriptasehæmmer, og tenofovirdisoproxil, som er et "prodrug" til tenofovir.
English: Emtricitabine/Tenofovir disoproxil Krka (emtricitabine / tenofovir disoproxil)
Danish: Emtricitabine/Tenofovir disoproxil Krka (emtricitabin/tenofovirdisoproxil)
English: Emtricitabine/Tenofovir disoproxil Krka is an HIV medicine that is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Emtricitabine/Tenofovir disoproxil Krka er et hivlægemiddel, der anvendes sammen med mindst ét andet hivlægemiddel til behandling af voksne, som er smittet med humant immundefektvirus type 1 (hiv-1).
English: Other information about Emtricitabine/Tenofovir disoproxil Krka
Danish: Andre oplysninger om Emtricitabine/Tenofovir disoproxil Krka
English: What are the benefits and risks of Emtricitabine/Tenofovir disoproxil Krka?
Danish: Hvilke fordele og risici er der forbundet med Emtricitabine/Tenofovir disoproxil Krka?
English: What is Emtricitabine/Tenofovir disoproxil Krka and what is it used for?
Danish: Hvad er Emtricitabine/Tenofovir disoproxil Krka, og hvad anvendes det til?
English: Why is Emtricitabine/Tenofovir disoproxil Krka authorised in the EU?
Danish: Hvorfor er Emtricitabine/Tenofovir disoproxil Krka godkendt i EU?
English: Emtricitabine/Tenofovir disoproxil Krka contains two active substances, emtricitabine and tenofovir disoproxil.
Danish: Emtricitabine/Tenofovir disoproxil Krka indeholder de to aktive stoffer emtricitabin og tenofovirdisoproxil.
English: For the treatment of HIV-1 infection, Emtricitabine/Tenofovir disoproxil Krka, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Ved behandling af hiv-1-infektion nedsætter Emtricitabine/Tenofovir disoproxil Krka hivmængden i blodet og holder den nede, når det anvendes i kombination med mindst ét andet antiviralt lægemiddel.
English: How has Emtricitabine/Tenofovir disoproxil Krka been studied?
Danish: Hvordan blev Emtricitabine/Tenofovir disoproxil Krka undersøgt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine/Tenofovir disoproxil Krka have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Emtricitabine/Tenofovir disoproxil Krka.
English: How is Emtricitabine/Tenofovir disoproxil Krka used?
Danish: Hvordan anvendes Emtricitabine/Tenofovir disoproxil Krka?
English: How does Emtricitabine/Tenofovir disoproxil Krka work?
Danish: Hvordan virker Emtricitabine/Tenofovir disoproxil Krka?
English: - First data-lock point is 30 days later.
Danish: Første data-lock point er 30 dage senere.
English: Date of first authorisation: 19 October 2009 Date of latest renewal: 18 July 2014
Danish: Dato for første markedsføringstilladelse: 19. oktober 2009 Dato for seneste fornyelse: 18. juli 2014
English: The following principles should be followed when compiling the data:
Danish: Følgende principper skal følges ved indsamling af data:
English: A line listing of fatal cases will be provided in an Annex.
Danish: En ”line listing” over fatale tilfælde vil blive leveret i et annex.
English: The following age groups will be used: < 2 years, 2-8 years, > 9 years.
Danish: Følgende aldersgrupper vil blive anvendt: < 2 år, 2-8 år, ≥ 9 år.
English: - Reporting to be monthly for the first 6 months.
Danish: Rapportering skal ske månedligt de første 6 måneder.
English: Format of the simplified PSUR
Danish: Format for simplificeret PSUR
English: Those which have not yet been entered should be reported in the following SPSUR.
Danish: De, der ikke endnu er blevet indtastede, skal rapporteres i den efterfølgende SPSUR.
English: • if you have a serious infection with a high temperature (over 38°C).
Danish: • hvis du har en alvorlig infektion med høj feber (over 38 °C).
English: Your doctor will decide the appropriate dose for your child.
Danish: Lægen vil afgøre, hvilken dosis der passer bedst til dit barn.
English: If this is not treated it may lead to shock.
Danish: Hvis dette ikke bliver behandlet, kan det medføre shock.
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 tidspunkt begrænsede.
English: • This will usually be in the upper arm.
Danish: • Den vil normalt blive givet i overarmen.
English: These data suggest that the excess risk tends to decline with increasing age at vaccination.
Danish: Disse data tyder på, at den forøgede risiko har tendens til at blive mindre med stigende alder på vaccinationstidspunktet.
English: Only spontaneously reported data should be included in the PSUR.
Danish: Kun spontant rapporteret data skal inkluderes i PSUR rapporten.
English: Read all of this leaflet carefully before you start receiving 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: It is important that procedures are in place to avoid injury from faints.
Danish: Det er vigtigt, at nødvendige foranstaltninger er til stede for at undgå skader i forbindelse med besvimelse.
English: All tables will be based on generic and not product-specific data1.
Danish: Alle tabeller baseres på generiske og ikke produktspecifikke data.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en godkendelse under særlige omstændigheder, og i henhold til artikel 14, stk. 8, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: - The clock should start from the first Monday after shipment of the first batch of vaccine.
Danish: Uret startes fra den første mandag efter afsendelse af den første vaccinebatch.
English: Moreover, a 6-monthly cycle may be too long to allow assessment of the safety of a vaccine for which high levels of exposure are expected within a short period of time.
Danish: Desuden kan en 6 månedlig cyklus være for lang til at kunne muliggøre vurdering af sikkerheden af en vaccine, hvor høj smitte er forventet inden for kort tid.
English: • They will give Adjupanrix as an injection into a muscle.
Danish: • De vil give Adjupanrix som en indsprøjtning i en muskel.
English: When it has been agreed by the CHMP that the S-PSUR is no longer necessary, a full PSUR covering the period since the data lock point of the last routine PSUR will be submitted within a time frame to be agreed with the Rapporteur.
Danish: Når det er blevet besluttet af CHMP, at S-PSUR ikke længere er nødvendig, skal en fuldstændig PSUR dækkende over perioden siden data-lock point af den seneste rutinemæssige PSUR indsendes inden for en tidsramme aftalt med Rapporteur.
English: When a person is given the vaccine, the body's natural defence system (immune system) produces its own protection (antibodies) against the disease.
Danish: Når en person vaccineres, danner kroppens naturlige forsvarsmekanisme (immunsystemet) sin egen beskyttelse (antistoffer) mod sygdommen.
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: Do not have Adjupanrix if any of the above apply to you.
Danish: Du må ikke få Adjupanrix, hvis noget af ovennævnte passer på dig.
English: “Cumulatively” means since the use of the vaccine; events not reported during the period of interest should not be presented in the tables.
Danish: Med ”Kumulativt” menes siden anvendelse af vaccinen; hændelser der ikke er rapporteret i den periode, der er af interesse, skal ikke fremgå af tabellerne.
English: All non-medically confirmed events are those that have been entered into the database by the data-lock point.
Danish: Alle ikke-medicinsk bekræftede hændelser er dem, der er blevet indtastet i databasen ved datalock point.
English: In the event of multiple signals, signal work-up may be prioritised and appropriate timelines for submission of a full signal evaluation report should be provided.
Danish: I tilfælde hvor der er flere signaler, skal udredningen af signalerne prioriteres og passende tidslinjer for indsendelse af en fuldstændig evalueringsrapport over signalerne skal angives.
English: PT “Vaccination failure”.
Danish: PT ”Vaccinationssvigt”.
English: Warning and precautions:
Danish: Advarsler og forsigtighedsregler:
English: Therefore, 6-monthly or annual PSURs falling within the pandemic period will be replaced by monthly “simplified PSURs” (S-PSUR) accompanied by a summary of vaccine distribution.
Danish: Halvårlig eller årlig PSUR, som falder inden for pandemi perioden vil derfor blive erstattet af månedlige ”simplificerede PSURs” (PSUR) ledsaget af en opsummering af vaccine distribution.
English: The vaccine contains an ‘adjuvant' AS03.
Danish: Vaccinen indeholder en ”adjuvans” AS03.
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 taking 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 råds, før du får denne vaccine.
English: It should be noted that the adverse reactions may be intensified.
Danish: Det skal bemærkes, at bivirkningsreaktionerne kan blive kraftigere.
English: Adjupanrix should be used in accordance with official guidance.
Danish: Adjupanrix skal anvendes i overensstemmelse med officielle retningslinjer.
English: narrow SMQ “Demyelination” (as GBS is also included in this SMQ, there will be an overlap in the number of cases for these two categories).
Danish: Snæver SMQ ”Demyelinering” (da GBS også er inkluderet i denne SMQ, vil der være et overlap i antallet af tilfælde for disse to kategorier) - Bells paralyse:
English: Frequency of submission
Danish: Hyppighed af indsendelse
English: Prophylaxis of influenza in an officially declared pandemic situation.
Danish: Influenzaprofylakse ved en officielt erklæret pandemisk situation.
English: • Serious stabbing or throbbing pain along one or more nerves
Danish: • Alvorlige, stikkende eller dunkende smerter langs en eller flere nerver
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/578/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/09/578/001
English: During a pandemic situation, the resources must be concentrated on a timely and effective monitoring of the safety profile of the influenza vaccines used during the pandemic.
Danish: Under en pandemi skal ressourcerne koncentreres omkring en rettidig og effektiv monitorering af sikkerhedsprofilen for influenzavaccine anvendt under pandemien.
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 første to indsprøjtninger vil blive givet på en bestemt dato og de næste to indsprøjtninger skal helst gives tre uger efter.
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 Adjupanrix.
Danish: En mindre infektion, f.eks. forkølelse, er normalt ikke noget problem, men lægen vil afgøre, om du kan blive vaccineret med Adjupanrix.
English: Interpandemic trivalent vaccines
Danish: Interpandemiske, trivalente 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 kvinder i hvert trimester af graviditeten.
English: After the addition of the adjuvant to the antigen, the mixture should be well shaken.
Danish: Efter tilsætning af adjuvans til antigen skal blandingen omrystes godt.
English: Older (>60 years)
Danish: Ældre (over 60 år)
English: - CHMP report is circulated to the vaccine manufacturer on Day 55.
Danish: CHMP rapport fremsendes til fremstilleren af vaccinen på dag 55.
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Danish: • hvis du skal have taget en blodprøve for at fastslå en infektion forårsaget af bestemte vira.
English: Tell the doctor requesting these tests that you have recently received Adjupanrix.
Danish: Fortæl til lægen, som har bedt om at få sådanne blodprøver foretaget, at du for nyligt har fået Adjupanrix
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 til mange årtier.
English: • This vaccine has been prescribed for you only.
Danish: • Lægen har ordineret denne vaccine til dig personligt.
English: PT “Bell's palsy”
Danish: PT ”Bell´s paralyse”
English: Your doctor or nurse will give you Adjupanrix.
Danish: En læge eller sygeplejerske vil give dig Adjupanrix.
English: Alternative schedules
Danish: Alternative programmer
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the Pharmacovigilance plan.
Danish: Under pandemien gennemfører ansøgeren en prospektiv kohorteundersøgelse som nævnt i farmakovigilanceplanen.