FrancophonIA/ELRC3.0 huggingface dataset:
English: In the management of partial onset seizures, Fycompa has been compared with placebo (a dummy treatment) in three main studies involving a total of 1,491 patients aged 12 years and older with partial-onset seizures who did not respond to other treatments.
Danish: I behandlingen af partielle anfald er Fycompa blevet sammenlignet med placebo (en virkningsløs behandling) i tre hovedundersøgelser, som omfattede i alt 1 491 patienter i alderen 12 år og opefter med partielle anfald, som ikke reagerede på andre behandlinger.
English: For the full list of all side effects and restrictions with Fycompa, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Fycompa fremgår af indlægssedlen.
English: The active substance in Fycompa, perampanel, is an anti-epileptic medicine.
Danish: Det aktive stof i Fycompa, perampanel, er et lægemiddel mod epilepsi.
English: Fycompa is also used in patients from 12 years of age to treat primary generalised tonic-clonic seizures (major fits or convulsions, where the person becomes unconscious, falls down if standing, and jerks or shakes) associated with idiopathic generalised epilepsy (epilepsy with no apparent cause that is thought to have a genetic origin and that affects the whole brain).
Danish: Fycompa anvendes også hos patienter i alderen 12 år og opefter til at behandle primære generaliserede tonisk-kloniske anfald (hvor vedkommende oplever alvorlige krampeanfald med bevidsthedstab, falder om og får trækninger eller rystelser) forbundet med idiopatisk generaliseret epilepsi (en form for epilepsi uden kendt årsag, som menes at være genetisk betinget, og som påvirker hele hjernen).
English: Although the precise mechanism by which Fycompa works is not fully understood, it is thought to block the action of the neurotransmitter glutamate.
Danish: Selvom det ikke vides med nøjagtighed, hvordan Fycompa virker, menes Fycompa at blokere virkningen af neurotransmitteren glutamat.
English: The third study showed a significant decrease in seizure frequency only in patients taking 4 mg and 8 mg Fycompa but not in patients taking a dose of 2 mg.
Danish: Den tredje undersøgelse viste kun et signifikant fald i anfaldshyppigheden hos patienter, der tog 4 mg og 8 mg Fycompa, men ikke hos patienter, der tog 2 mg.
English: What is the risk associated with Fycompa?
Danish: Hvilken risiko er der forbundet med Fycompa?
English: Why has Fycompa been approved?
Danish: Hvorfor blev Fycompa godkendt?
English: For patients with primary generalised tonic-clonic seizures Fycompa was also more effective than placebo: 47 of 81 patients (58%) given Fycompa had at least a 50% reduction in frequency of seizures, compared with 29 of 81 (36%) of those given the dummy treatment.
Danish: Hos patienter med primære generaliserede tonisk-kloniske anfald var Fycompa også mere effektivt end placebo: 47 ud af 81 patienter (58 %), der modtog Fycompa, oplevede en nedgang i anfaldshyppigheden på mindst 50 % sammenlignet med 29 ud af 81 patienter (36 %), der modtog placebo.
English: Therefore by blocking glutamate's actions, Fycompa is thought to stop epileptic seizures from occurring.
Danish: Ved at blokere glutamats virkning menes Fycompa at kunne forhindre epileptiske anfald i at opstå.
English: Fycompa was compared with placebo as an addition to patients' existing epilepsy treatment.
Danish: Fycompa blev sammenlignet med placebo som tillægsbehandling til patienternes øvrige behandling.
English: In the second study, 33.3% and 33.9% of patients taking 8 mg and 12 mg Fycompa respectively showed a decrease in seizure frequency of at least 50%, compared with 14.7% of patients taking placebo.
Danish: I den anden undersøgelse var der hos 33,3 % og 33,9 % af de patienter, der tog hhv. 8 mg og 12 mg Fycompa, en nedgang i anfaldshyppigheden på mindst 50 %, sammenlignet med 14,7 % hos de patienter, der tog placebo.
English: Fycompa must only be used as an ‘add-on' therapy to other anti-epileptic medicines.
Danish: Fycompa må udelukkende anvendes som en tillægsbehandling til andre lægemidler mod epilepsi.
English: What is Fycompa?
Danish: Hvad er Fycompa?
English: In the first study, the percentage of patients who experienced a decrease in seizure frequency of at least 50% was 37.6% for patients taking 8 mg Fycompa and 36.1% for patients taking 12 mg Fycompa, compared with 26.4% of patients taking placebo.
Danish: I den første undersøgelse var procentdelen af patienter, der oplevede en nedgang i anfaldshyppigheden på mindst 50 %, 37,6 % for patienter, der tog 8 mg Fycompa, og 36,1 % for patienter, der tog 12 mg Fycompa, sammenlignet med 26,4 % for patienter, der tog placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fycompa have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Fycompa.
English: Treatment was started at a dose of 2 mg of Fycompa and gradually increased over 4 weeks to a maximum of 8 mg if tolerated, then continued for a further 13 weeks.
Danish: Ved behandlingens start blev Fycompa givet i doser på 2 mg, som gradvist blev øget til højst 8 mg over 4 uger, hvis dette kunne tolereres.
English: The recommended dose at the start of treatment is 2 mg per day, and if it is well tolerated the doctor may progressively increase it by increments of 2 mg/day to a maximum dose of 12 mg per day.
Danish: Hvis denne dosis tolereres godt, kan lægen gradvist øge dosen med stigninger på 2 mg dagligt til en maksimal dosis på 12 mg dagligt.
English: What is Fycompa used for?
Danish: Hvad anvendes Fycompa til?
English: How has Fycompa been studied?
Danish: Hvordan blev Fycompa undersøgt?
English: How is Fycompa used?
Danish: Hvordan anvendes Fycompa?
English: What benefit has Fycompa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fycompa?
English: How does Fycompa work?
Danish: Hvordan virker Fycompa?
English: You and your child may need to read it again.
Danish: Du/dit barn kan få brug for at læse den igen.
English: It is currently difficult to explain if this phenomenon is treatment related or not.
Danish: Det er i øjeblikket vanskeligt at forklare, om dette fænomen er behandlingsrelateret eller ej.
English: Safety and tolerability was evaluated in the entire study population.
Danish: Sikkerhed og tolerabilitet blev vurderet hos hele studiepopulationen.
English: If the vaccine has been frozen it should not be used.
Danish: Hvis vaccinen har været nedfrosset, bør den ikke anvendes.
English: Confusion and agitation also occur in the early stage of disease.
Danish: Konfusion og uro optræder også i den tidlige sygdomsfase.
English: Blank white foil without any printed information.
Danish: Blankt hvidt folie uden trykte oplysninger.
English: Many infected people develop mild symptoms or no symptoms at all.
Danish: Mange smittede mennesker udvikler milde eller slet ingen symptomer.
English: Mathematical modelling was applied to project the average duration of protection.
Danish: Der blev anvendt matematisk modellering til at projicere den gennemsnitlige varighed af beskyttelse.
English: In this case, your doctor will postpone the vaccination.
Danish: Hvis det er tilfældet, vil lægen udsætte vaccinationen.
English: The pre-filled syringe is for single use only and should not be used for more than one person.
Danish: Den fyldte sprøjte er kun til engangsbrug og må ikke bruges til mere end én person.
English: A-1030 Vienna
Danish: A-1030 Wien
English: Please note that:
Danish: Bemærk, at:
English: Approximately 40% of treated subjects experienced systemic adverse reactions and approximately 54% experienced injection site reactions.
Danish: Omkring 40 % af de behandlede personer oplevede systemiske bivirkninger, og cirka 54 % oplevede reaktioner på injektionsstedet.
English: n.a. 95% Confidence Interval could not be established (single-subject data)
Danish: n.a. 95 % konfidensinterval kunne ikke fastslå (enkelt-emne data)
English: All of the 198 subjects treated were included in the ITT and Safety Populations.
Danish: Alle de behandlede 198 forsøgspersoner blev inkluderet i ITT og sikkerhedspopulationerne.
English: Tell your doctor:
Danish: Fortæl det til lægen, hvis:
English: Your doctor will decide on the requirement and timing for booster doses.
Danish: Lægen vil bestemme behovet og timingen for boosterdoser.
English: This product might contain traces of residual sodium metabisulfite which is below detection limit.
Danish: Dette produkt kan indeholde spor af resterende natriummetabisulfit, der ligger under detektionsgrænsen.
English: Paediatric population No interaction studies have been performed in children and adolescents.
Danish: Pædiatrisk population Der er ikke udført interaktionsstudier hos børn og unge.
English: This virus is mainly found in Asia and is transmitted to humans by mosquitoes that have bitten an infected animal (like pigs).
Danish: Dette virus findes hovedsageligt i Asien og overføres til mennesker via myg, der har stukket et dyr, der er smittet (f.eks. grise).
English: Your doctor will discuss with you the possible risks and benefits of receiving IXIARO.
Danish: Din læge vil tale med dig om de mulige risici og fordele ved at få IXIARO.
English: Read all of this leaflet carefully before you or your child receive this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du/dit barn får denne vaccine, da den indeholder vigtige oplysninger.
English: Non-clinical toxicity data are limited.
Danish: Der foreligger begrænsede ikke-kliniske toksicitetsdata.
English: If the primary immunization of two injections is not completed, full protection against the disease might not be achieved.
Danish: Hvis den primære immunisering med to injektioner ikke er fuldført, opnås der muligvis ikke fuld beskyttelse mod sygdommen.
English: Pre-Vaccination Day 56
Danish: Prævaccination Dag 56
English: The vaccine causes the body to produce its own protection (antibodies) against this disease.
Danish: Vaccinen får kroppen til at danne sit eget forsvarssystem (antistoffer) mod denne sygdom.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin have bivirkninger, men ikke alle får bivirkninger.
English: ), host cell protein.
Danish: 2), værtscelleprotein.
English: Administration must be postponed in persons with acute severe febrile conditions.
Danish: Vaccinering skal udsættes hos personer med akut alvorlig feberlidelse.
English: No symptoms related to overdose were reported.
Danish: Der er ikke rapporteret symptomer relateret til overdosering.
English: Immunogenicity data were evaluated in 64 subjects.
Danish: Der blev evalueret immunogenicitetsdata for 64 forsøgspersoner.
English: Date of first authorisation: 31 March 2009 Date of latest renewal: 22 November 2018
Danish: Dato for første markedsføringstilladelse 31. marts 2009 Dato for seneste fornyelse: 28. februar 2014
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at øge sporbarheden af biologiske lægemidler, skal navnet og batchnummeret på det administrerede præparat tydeligt registreres.
English: There was also no interference with the immune response to Rabipur.
Danish: Der var heller ikke nogen interferens med immunresponset på Rabipur.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene til indsendelse af periodiske sikkerhedsopdateringsrapporter for dette lægemiddel, er bestemt i listen over EU-referencedatoer (EURD-liste), der er fastsat i henhold til artikel 107c (7), i direktiv 2001/83 / EF og enhver efterfølgende opdatering offentliggjort på den Europæiske Webportal over lægemidler.
English: Aluminium hydroxide is included in this vaccine as an adjuvant.
Danish: Aluminiumhydroxid indgår i vaccinen som et adjuvans.
English: However, incomplete ossification of parts of the skeleton was observed in the group receiving 2 doses, but not in the group receiving 3 doses.
Danish: Der blev dog observeret en ufuldstændig forbening af skelettet i den gruppe, der fik 2 doser, men ikke i den gruppe, der fik 3 doser.
English: Attach a new sterile needle prior to injection of the remaining volume.
Danish: Påsæt en ny, steril kanyle før injektion af det resterende volumen.
English: The observed decline in GMT is as expected and compares well with data from other inactivated JE vaccines.
Danish: Det observerede fald i GMT er forventet og svarer godt til data fra andre inaktiverede JE-vacciner.
English: In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: Officiel batchfrigivelse: I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: ATC code: J07BA02
Danish: ATC-kode: J07BA02
English: 1 produced in Vero cells
Danish: 1 fremstillet i veroceller
English: Data are limited but there were no differences in the safety profile between the 0.25 ml and the 0.5 ml dose in this age group.
Danish: Data er begrænsede, men der var ingen forskel på sikkerhedsprofilen mellem 0,25- og 0,5 ml-dosen hos denne aldersgruppe.
English: Without Booster N = 150
Danish: Uden booster N = 150
English: Frequency of adverse reactions(%) by dose/age
Danish: Frekvens af bivirkninger (%) efter dosis/alder
English: No prospective efficacy trials have been performed.
Danish: Der er ikke foretaget prospektive effektivitets studier.
English: For elderly persons (>65 years) the first booster dose may be given earlier.
Danish: Til ældre personer (>65 år) kan den første boosterdosis tidligere.
English: Based on this model, it is estimated that average duration of protection will be 14 years and 75% of vaccinees will retain protective antibody levels (PRNT50≥1:10) for 10 years.
Danish: Baseret på denne model skønnes det, at den gennemsnitlige varighed af beskyttelse vil være 14 år og 75 % af vaccinerne vil bevare det beskyttende antistofniveau (PRNT50≥1: 10) i 10 år.
English: Pharmacotherapeutic group: Vaccines, Viral vaccines, Encephalitis vaccines.
Danish: Farmakoterapeutisk klassifikation: Vacciner, virale vacciner, encefalitisvacciner.
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 receiving 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: In adults, a second booster can be given 10 years after the first booster.
Danish: Til voksne kan en anden booster gives 10 år efter den første booster.
English: The majority of the side effects listed below have been observed during clinical trials.
Danish: Størstedelen af nedenstående bivirkninger er set i de kliniske studier.
English: In infants, the anterolateral aspect of the thigh may be used as injection site.
Danish: Hos småbørn kan den anterolaterale del af låret anvendes som injektionssted.
English: Booster dose (Children and adolescents)
Danish: Boosterdosis (børn og teenagere)
English: If your or your child's immune system does not work properly (immunodeficiency) or you and/or your child are taking medicines affecting your immune system (such as a medicine called cortisone or cancer medicine).
Danish: • Hvis dit eller dit barns immunsystem ikke fungerer ordentligt (immundefekt), eller du og/eller dit barn tager medicin, der påvirker dit immunsystem (som f.eks. et lægemiddel kaldet kortison eller kræftmedicin).
English: No case of overdose has been reported in the paediatric population.
Danish: Der er ikke rapporteret tilfælde af overdosering hos den pædiatriske population.
English: 1 dose (0.5 ml) of IXIARO contains:
Danish: 1 dosis (0,5 ml) IXIARO indeholder:
English: Make sure you and/or your child finish the complete vaccination course of 2 injections.
Danish: Sørg for, at du/dit barn fuldfører det fuldstændige vaccinationsforløb med to injektioner.
English: Protection against Japanese Encephalitis is not ensured until the second dose has been received.
Danish: Beskyttelse mod japansk encefalitis er ikke sikret før efter den anden dosis.
English: Total Study Population Age group >65 - <75years
Danish: Total studiepopulation Aldersgruppe >65 - <75 år
English: Seroconversion rate
Danish: Serokonverteringsrate
English: However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
Danish: Det skal dog bemærkes, at der ikke findes data om klinisk effektivitet ved subkutan indgivelse.
English: The immune responses to further doses at different time points after complete or incomplete primary immunization are shown in table 6.
Danish: Immunresponserne på yderligere doser på forskellige tidspunkter efter fuldstændig eller ufuldstændig primær immunisering er vist i tabel 6.
English: In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immune response may not be obtained.
Danish: Det er ikke sikkert, at patienter i immunsuppressiv behandling eller patienter med immundefekt kan udvikle et tilstrækkeligt immunrespons.
English: corresponding to a potency of ≤ 460 ng ED50
Danish: svarende til en styrke på ≤ 460 ng ED50
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.>
English: Parents or subjects recorded adverse events on a diary card for the first seven days after each vaccination.
Danish: Forældre eller forsøgspersoner registrerede bivirkninger på et dagbogskort i de første syv dage efter hver vaccination.
English: These studies showed that almost all mice that had a Plaque Reduction Neutralization Test titre of at least 1:10 were protected from a lethal Japanese encephalitis virus challenge.
Danish: Det fremgik af disse studier, at næsten alle mus, der havde en neutraliserende plaquereduktionsprøvetiter på mindst 1:10, var beskyttet mod et dødeligt angreb fra japansk encefalitisvirus.
English: In animal studies findings of unclear clinical relevance have been identified (see section 5.3).
Danish: Ved dyreforsøg er der blevet påvist en uklar klinisk relevans (se pkt.
English: As with many vaccines, the immune response in elderly persons to IXIARO is lower than in younger adults.
Danish: Som for mange vacciner er immunresponset på IXIARO lavere end hos yngre voksne.
English: Long-term seroprotection following a booster-dose is not known.
Danish: De langsigtede serobeskyttende data efter en boosterdosis er ikke kendt.
English: If your child is younger than 2 months of age, since IXIARO has not been tested in infants younger than 2 months of age.
Danish: • Hvis dit barn er under 2 måneder gammelt, da IXIARO ikke er blevet afprøvet på småbørn under 2 måneder
English: IXIARO has no or negligible influence on the ability to drive and use machines.
Danish: IXIARO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: No increase in the number of adverse reactions was noted between first and second doses or following a booster dose in adults.
Danish: Der blev ikke observeret nogen stigning i antallet af bivirkninger mellem første og anden dosis eller efter en boosterdosis hos voksne.
English: Month 2 98.9 (179/181) Month 6 95.0 (172/181) Month 12 83.4 (151/181) Month 24 81.8 (148/181) Month 36 84.9 (129/152)
Danish: Måned 2 98,9 (179/181) Måned 6 95,0 (172/181) Måned 12 83,4 (151/181) Måned 24 81,8 (148/181) Måned 36 84,9 (129/152)
English: Longterm immunogenicity data were evaluated in 23 children, mean age 14.3 years, range 3 - 18 years).
Danish: Langsigtede immunogenicitetsdata blev evalueret for 23 børn med en gennemsnitsalder på 14,3 år (interval 3 - 18 år).
English: Day 0 Day 14
Danish: Dag 0 Dag 14
English: Email: infoixiaro@valneva.com
Danish: E-mail: infoixiaro@valneva.com
English: Booster dose 12 months after primary immunization N = 149
Danish: Boosterdosis 12 måneder efter primær immunisering N = 149
English: Age group ≥75 years
Danish: Aldersgruppe ≥75 år
English: A total of 116 subjects who had received the recommended primary schedule of IXIARO were included in this follow-up study.
Danish: Et samlet antal på 116 forsøgspersoner, som havde fået den anbefalede primære dosis IXIARO, blev inkluderet i denne opfølgende undersøgelse.
English: Phosphate Buffered Saline 0.0067 M (in PO4) has the following saline composition: NaCl - 9mg/mL
Danish: Fosfatbufret saltvand 0,0067 M (i PO4) har følgende saltsammensætning: NaCl - 9 mg/ml
English: If you and/or your child are ill with a high fever.
Danish: • Hvis du og/eller dit barn er syg med høj feber.
English: If you and/or your child have developed an allergic reaction after receiving a former dose of IXIARO.
Danish: • Hvis du og/eller dit barn har udviklet en allergisk reaktion efter tidligere at have fået IXIARO.
English: They usually occur within the first 3 days after vaccination, are usually mild and disappear within a few days.
Danish: De indtræder normalt inden for de første 3 dage efter vaccinationen, de er normalt milde og forsvinder inden for nogle få dage.
English: The safety profile of IXIARO was comparable to that of Havrix or Prevenar.
Danish: Sikkerhedsprofilen for IXIARO var sammenlignelig med profilen for Havrix eller Prevenar.
English: IXIARO cannot cause the disease it protects against.
Danish: • IXIARO ikke kan forårsage den sygdom, det beskytter imod
English: Seroconversion rates and antibody titers also remained comparably high up to 12 months after the first immunisation in both schedules (Table 5).
Danish: Serokonverteringsrater og antistoftitre forblev også forholdsvis høje op til 12 måneder efter den første immunisering i begge vaccinationsplaner (tabel 5).
English: Challenge studies were performed in mice that were treated with human IXIARO antisera.
Danish: Der blev udført challenge-studier med mus, som blev behandlet med IXIARO antisera fra mennesker.
English: The pre-filled syringe is ready to use.
Danish: Den fyldte sprøjte er klar til brug.
English: ◊Negative Pre-Vaccination titers were imputed to 5.
Danish: Måned 7 ◊Negative prævaccinationstitre blev sat til 5.
English: Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose.
Danish: Hos personer, som viser overfølsomhedsreaktioner efter første dosis af vaccinen, skal anden dosis undlades.
English: The immune responses elicited by IXIARO are presented in Table 10.
Danish: De immunresponser, der blev fremkaldt af IXIARO, er præsenteret i Tabel 10.
English: This vaccine has been prescribed for you and/or your child only.
Danish: • Lægen har ordineret denne vaccine til dig og/eller dit barn personligt.
English: In another open-label, follow-up Phase 3 study, the persistence of antibodies up to 24 months after primary vaccination was assessed.
Danish: I en anden open-label, opfølgende fase 3 undersøgelse blev antistofpersistensen vurderet i op til 24 måneder efter primær vaccination.
English: Adults (18 to ≤ 65 years of age)
Danish: Voksne (18 til ≤65 år)
English: IXIARO is a white and slightly milky sterile suspension, which becomes homogenous on shaking.
Danish: IXIARO er en hvid og lidt mælkeagtig steril suspension, der bliver homogen ved omrystning.