FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used with sultopride (an antipsychotic medicine), or medicines known to cause QTc prolongation (an alteration of the electrical activity of the heart).
Danish: Det må ikke anvendes sammen med sultoprid (et antipsykotisk lægemiddel) eller lægemidler, som er kendt for at kunne forårsage QTc-forlængelse (en ændring af hjertets elektriske aktivitet).
English: Firdapse was more effective than placebo at treating patients with LEMS.
Danish: Firdapse var mere effektivt end placebo til behandling af patienter med LEMS.
English: In two published studies involving a total of 38 adults with LEMS, amifampridine was compared with placebo (a dummy treatment).
Danish: I to offentliggjorte undersøgelser, der omfattede i alt 38 voksne med LEMS, blev amifampridin sammenlignet med placebo (en virkningsløs behandling).
English: The full EPAR for Firdapse can be found can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Firdapse findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is the risk associated with Firdapse?
Danish: Hvilken risiko er der forbundet med Firdapse?
English: The main measures of effectiveness were based on the rating of how well the muscles worked using a scoring system, either the neurological disability score (NDS) or the quantitative myasthenia gravis (QMG) score.
Danish: Det primære effektmål var baseret på en vurdering af, hvor godt musklerne fungerede, ved hjælp af et scoresystem, hvor man enten anvendte scoren for neurologiske lidelser (NDS) eller scoren for kvantitativ myasthenia gravis (QMG).
English: The CHMP decided that Firdapse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Firdapse er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Firdapse.
English: What information is still awaited for Firdapse?
Danish: Hvilke oplysninger afventes der stadig for Firdapse?
English: Additionally, the effect of Firdapse on the QT interval (the electrical activity of the heart) was investigated.
Danish: Desuden blev virkningen af Firdapse på QT-intervallet (den elektriske aktivitet i hjertet) undersøgt
English: The most common side effects reported with Firdapse are paraesthesia (unusual sensations like pins and needles) and gastro-intestinal disorders such as epigastralgia (pain around the upper part of the stomach), diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Danish: De hyppigste indberettede bivirkninger ved Firdapse er paræstesi (usædvanlig prikkende og snurrende fornemmelse) og gastrointestinale lidelser såsom epigastralgi (smerter i den øvre del af maven), diarré, kvalme og abdominale smerter (mavesmerter).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Firdapse, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Firdapse, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Firdapse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Firdapse findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This means that because the disease is rare, it has not been possible to obtain complete information about Firdapse.
Danish: Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om Firdapse, da sygdommen er sjælden.
English: In the QT study, amifampridine was observed to have no effects on the activity of the heart, as shown by the electrocardiograms of healthy volunteers taking part in this study.
Danish: I QT-undersøgelsen kunne det iagttages, at amifampridin ikke havde nogen effekt på hjertets aktivitet, hvilket fremgår af elektrokardiogrammerne for de raske frivillige, der deltog i undersøgelsen.
English: LEMS is a disease in which patients have muscle weakness because of a failure of the nerves to transmit electrical impulses to the muscles.
Danish: LEMS er en sygdom, hvor patienterne får muskelsvaghed, fordi nerverne ikke er i stand til at sende elektriske impulser til musklerne.
English: Why has Firdapse been approved?
Danish: Hvorfor blev Firdapse godkendt?
English: Firdapse must not be used in patients who have epilepsy or in patients with uncontrolled asthma or congenital QT syndromes (disruption of the heartbeat).
Danish: Firdapse må ikke anvendes til patienter, der har epilepsi, eller til patienter med ukontrolleret astma eller medfødt QT-syndrom (uregelmæssig hjerterytme).
English: Additionally, the company that markets Firdapse has been required to set up a patient registry for patients with LEMS.
Danish: Desuden skal den virksomhed, der markedsfører Firdapse, oprette et register for patienter med LEMS.
English: This prolongs the period of depolarisation, allowing more time for the nerves to release acetylcholine and so stimulate the muscles to contract.
Danish: Dette forlænger depolariseringsperioden, og det giver nerverne mere tid til at frigive acetylcholin og derved stimulere musklerne til at trække sig sammen.
English: For the full list of all side effects and restrictions with Firdapse, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Firdapse fremgår af indlægssedlen.
English: The active substance in Firdapse, amifampridine, is a potassium channel blocker, which prevents charged potassium particles from leaving the nerve cells.
Danish: Det aktive stof i Firdapse, amifampridin, blokerer kaliumkanalerne, hvilket forhindrer ladede kaliumpartikler i at forlade nervecellerne.
English: For muscles to contract, nerves have to transmit electrical impulses to the muscles through a chemical messenger called acetylcholine.
Danish: For at musklerne kan trække sig sammen, skal nerverne sende elektriske impulser til musklerne via en kemisk transmitter, der kaldes acetylcholin.
English: What is Firdapse?
Danish: Hvad er Firdapse?
English: In one study, the NDS was reduced from 40 to 22 points in patients taking Firdapse compared with a drop to 35 points in patients taking placebo.
Danish: I den ene af undersøgelserne blev NDS reduceret fra 40 til 22 point hos patienter, der tog Firdapse, sammenlignet med et fald til 35 point hos patienter, der tog placebo.
English: The other study showed a reduction in the QMG score of 2 points in patients taking Firdapse compared with a rise of 0.25 points in patients taking placebo.
Danish: Den anden undersøgelse viste en reduktion i QMG-scoren med 2 point hos patienter, der tog Firdapse, sammenlignet med en stigning på 0,25 point hos patienter, der tog placebo.
English: What is Firdapse used for?
Danish: Hvad anvendes Firdapse til?
English: In the third combined study, patients taking Firdapse had better improvements in CMAP than patients taking placebo.
Danish: I den tredje kombinerede undersøgelse var der større forbedringer i CMAP hos patienter, der tog Firdapse, end hos patienter, der tog placebo.
English: How has Firdapse been studied?
Danish: Hvordan blev Firdapse undersøgt?
English: What benefit has Firdapse shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Firdapse?
English: How is Firdapse used?
Danish: Hvordan anvendes Firdapse?
English: How does Firdapse work?
Danish: Hvordan virker Firdapse?
English: Alternative vaccination schedules:
Danish: Alternative vaccinationsprogrammer:
English: AFLUNOV should be used in accordance with official recommendations.
Danish: AFLUNOV skal anvendes i overensstemmelse med de officielle anbefalinger.
English: In such cases, the Western Blot method is negative.
Danish: I sådanne tilfælde vil Western Blot-metoden være negativ.
English: Date of first authorisation: 29 November 2010 Date of latest renewal: 17 July 2015
Danish: Dato for første markedsføringstilladelse: 29. november 2010 Dato for seneste fornyelse: 17. juli 2015
English: Similar trends were observed for seroprotection rates in both studies.
Danish: Der blev observeret tilsvarende tendenser for seroprotektionsrater i begge studier.
English: If this applies to you then your vaccination will usually be postponed until you are feeling better.
Danish: Hvis dette gælder for dig, vil din vaccination som regel blive udsat, indtil du har det bedre.
English: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italy.
Danish: Via del Pozzo 3/A, S. Martino 53035 Monteriggioni (SI) Italien.
English: There are no data concerning human fertility.
Danish: Der foreligger ingen data vedrørende human fertilitet.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be taken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: Other rare side effects observed after routine use:
Danish: Andre sjældne bivirkninger, som er set efter rutinemæssig brug:
English: - Other ingredients:
Danish: - Øvrige indholdsstoffer:
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Danish: Når en person får vaccinen, vil immunsystemet (kroppens naturlige forsvar) skabe sin egen beskyttelse (antistoffer) mod sygdommen.
English: HI results for the two clinical studies revealed lower values than those reported in previous studies.
Danish: HI-resultater for de to kliniske studier viste lavere værdier end de, der er rapporteret i tidligere studier.
English: 1105BJ Amsterdam Netherlands
Danish: 1105BJ Amsterdam Holland
English: Periodic Safety Update Reports (PSURs)
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Human infections are primarily caused by contact with infected animals, but do not spread easily between people.
Danish: Infektioner hos mennesker opstår primært ved kontakt med inficerede dyr og spredes ikke let mellem mennesker.
English: These transitory false positive results may be due to IgM production in response to the vaccine.
Danish: Disse forbigående falsk positive resultater kan skyldes IgM-produktion som respons på vaccinen.
English: - Italy
Danish: - Italien
English: Visually inspect the suspension prior to administration.
Danish: Inspicér suspensionen visuelt inden administration.
English: • if you have a severe infection with a high temperature (over 38°C).
Danish: • hvis du har en alvorlig infektion og feber (temperatur over 38 °C).
English: None of the ingredients in the vaccine can cause flu.
Danish: Ingen af ingredienserne i vaccinen kan give influenza.
English: Subjects with underlying medical or immunosuppressive conditions:
Danish: Forsøgspersoner med underliggende medicinske eller immunsuppressive tilstande:
English: SP= seroprotection SC= seroconversion
Danish: SP = seroprotektion SC = serokonvertering
English: In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Danish: I tilfælde af eventuelle partikler og/eller abnormt udseende skal vaccinen kasseres.
English: Any Other Adverse Event
Danish: Enhver anden utilsigtet hændelse
English: • Severe stabbing or throbbing pain along one or more nerves
Danish: • Stikkende eller pulserende smerte langs en eller flere nerver
English: Fever ≥ 38°C (≥ 40°C)
Danish: Feber ≥ 38 °C (≥ 40 °C)
English: Cross reactivity data in adults
Danish: Krydsreaktivitetsdata for voksne
English: Vaccination is currently not recommended in this age group.
Danish: Vaccinering anbefales i øjeblikket ikke hos denne aldersgruppe.
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Danish: Det immunologiske respons kan blive nedsat, hvis patienten er i immunsuppressiv behandling.
English: Tell your doctor if you have a weak immune system or an underlying long term medical problem.
Danish: Fortæl lægen, hvis du har et svagt immunforsvar eller et underliggende langvarigt medicinsk problem.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen (efter Exp) er den sidste dag i den nævnte måned.
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 forbedre sporbarheden af biologiske lægemidler skal navn og batchnummer på det administrerede præparat registreres tydeligt.
English: ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Local Systemic
Danish: Lokale Systemiske
English: Results are shown by SRH.
Danish: Resultaterne er vist ved SRH.
English: AFLUNOV is intended also to be given when there is anticipation of a possible pandemic due to the same or a similar strain.
Danish: AFLUNOV er også beregnet til at blive givet, når der er forventning om en mulig pandemi som følge af den samme eller en tilsvarende stamme.
English: Clinical trials in special populations
Danish: Kliniske studier i specielle populationer
English: It is important that procedures are in place to avoid injury from faints
Danish: Det er vigtigt at træffe sikkerhedsforanstaltninger for at undgå kvæstelser ved besvimelse.
English: Immunization shall be postponed in patients with febrile illness or acute infection.
Danish: Immunisering skal udskydes hos patienter med febril sygdom eller akut infektion.
English: A second dose of 0.5 ml should be given after an interval of at least 3 weeks.
Danish: Der bør gives endnu en dosis på 0,5 ml efter et interval på mindst 3 uger.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Danish: Lægerne kender til denne risiko, og de har derfor udstyr til akut behandling til brug i disse tilfælde.
English: In a similar study, intranasal challenge was delayed until approximately 4 months after the second dose of vaccine was administered.
Danish: I et lignende studie blev intranasal challenge udskudt til ca. 4 måneder efter administration af den anden dosis vaccine.
English: - Adjuvant MF59C.1:
Danish: - Adjuvans MF59C.1:
English: Further information);
Danish: Yderligere oplysninger)
English: Long term booster immune memory:
Danish: Langsigtet booster-immunhukommelse:
English: Paediatric population The safety and efficacy of AFLUNOV in subjects under 18 years of age have not yet been established.
Danish: Pædiatrisk population AFLUNOVs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Danish: En sådan situation kræver hurtig indberetning af sikkerhedsoplysninger, der i høj grad kan påvirke balancen mellem risici og fordele under en pandemi.
English: In the absence of compatibility trials, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
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 afgøre, om du har bestemte virusinfektioner.
English: It should be noted that the adverse reactions may be intensified.
Danish: Det skal bemærkes, at bivirkningerne kan intensiveres.
English: The percentages of subjects reporting local reactions were higher in the older age groups, mainly due to the higher reports for pain.
Danish: Procentdelen af forsøgspersoner, der rapporterede om lokale reaktioner, var højere i de ældste aldersgrupper, hovedsagelig pga. flere rapporter om smerte.
English: Irrespective of antigen dose, almost all systemic reactions were reported on the day of vaccination (day 1) or during the 3 days immediately following.
Danish: Uanset antigendosis blev næsten alle systemiske reaktioner indberettet på vaccinationsdagen (dag 1) eller i løbet af de efterfølgende 3 dage.
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Danish: Lægen eller sygeplejersken vil give dig vaccinen i overensstemmelse med de officielle retningslinjer.
English: Immunogenicity was assessed in 182 subjects.
Danish: Immunogeniciteten blev vurderet hos 182 forsøgspersoner.
English: In addition, vomiting was commonly reported.
Danish: Endvidere er opkastning hyppigt rapporteret.
English: No data are available in children aged less than 6 months.
Danish: Der foreligger ingen data for børn under 6 måneder.
English: Vaccination protected animals from lethal challenge even when HI antibody titres were low or undetectable.
Danish: Vaccination beskyttede dyrene mod letal challenge, selv når HI-antistoftitrene var lave eller ikke kunne detekteres.
English: Children from 6 months to 17 years of age
Danish: Børn fra 6 måneder til 17 år
English: Lung damage was reduced in vaccinated groups.
Danish: Lungeskader var mindre hos de vaccinerede grupper.
English: Children aged less than 6 months of age Vaccination is currently not recommended in this age group.
Danish: Børn under 6 måneder Vaccinering anbefales i øjeblikket ikke hos denne aldersgruppe.
English: In addition, the side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent seasonal flu.
Danish: Herudover er bivirkningerne i listen nedenfor set i dagene eller ugerne efter vaccination med vacciner, som gives rutinemæssigt hvert år for at forebygge sæsoninfluenza.
English: Efficacy against challenge with the heterologous virus A/Indonesia/5/2005 was also tested.
Danish: Virkning mod challenge med det heterologe virus A/Indonesia/5/2005 blev også testet.
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation 726/2004/EC will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Danish: Under en pandemisk situation vil den hyppighed, hvormed PSUR'er skal indsendes i henhold til artikel 24 i forordning 726/2004/EF, ikke være tilstrækkelig til sikkerhedsovervågning af en pandemisk vaccine, for hvilken der forventes høje eksponeringsniveauer inden for et kort tidsrum.
English: In such cases, you should be aware that the side effects may be more intense.
Danish: I sådanne tilfælde skal du være opmærksom på, at bivirkningerne kan være mere intense.
English: Your doctor needs to assess the benefits and potential risks of giving you the vaccine.
Danish: Din læge må vurdere fordelene og de mulige risici ved at give dig vaccinen.
English: These side effects usually disappear within 1-2 days without treatment.
Danish: Disse bivirkninger forsvinder som regel inden for 1-2 dage uden behandling.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse 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 eller sundhedspersonalet til råds, før du får vaccinen.
English: Post-marketing spontaneously reported adverse events and an interventional study do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Danish: Spontant rapporterede utilsigtede hændelser efter markedsføring og et interventionsstudie tyder ikke på direkte eller indirekte skadelige virkninger af Focetria-ekponering på graviditet.
English: • Neuritis (inflammation of nerves)
Danish: • Neuritis (nervebetændelse)
English: Pharmacotherapeutic group: Influenza vaccine ATC Code J07BB02.
Danish: Farmakoterapeutisk klassifikation: Influenzavaccine, ATC-kode J07BB02.
English: After shaking, the normal appearance of AFLUNOV is a milky-white suspension.
Danish: Efter omrystning er det normale udseende af AFLUNOV en mælkehvid suspension.
English: One dose of 0.5 ml at an elected date.
Danish: En dosis på 0,5 ml på en udvalgt dato.
English: In this study 100% of animals were protected against homologous challenge, and 81% of animals were protected against heterologous challenge.
Danish: I dette studie var 100 % af dyrene beskyttet mod homolog challenge, og 81 % af dyrene var beskyttet mod heterolog challenge.
English: The majority of these side effects usually disappear within 1-2 days without treatment.
Danish: Hovedparten af disse bivirkninger forsvinder som regel inden for 1-2 dage uden behandling.
English: The vaccine should under no circumstances be administered intravascularly or intradermally.
Danish: Vaccinen må under ingen omstændigheder administreres intravaskulært eller intradermalt.
English: In addition, two large observational studies designed to assess the safety of Focetria exposure in pregnancy showed no increase in the rates of gestational diabetes, preeclampsia, abortions, stillbirth, low birth weight, prematurity, neonatal deaths, and congenital malformations among almost 10,000 vaccinated pregnant women and their offspring compared with unvaccinated controls.
Danish: Endvidere viste to store observationsstudier, der var rettet mod vurdering af sikkerheden af Focetriaeksponering under graviditet, ingen stigning i forekomsten af gestationel diabetes, præeklampsi, aborter, dødfødsler, lav fødselsvægt, præmaturitet, neonatal død og medfødte misdannelser blandt næsten 10.000 vaccinerede gravide kvinder og deres børn sammenlignet med ikke-vaccinerede kontroller.
English: Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, human T-lymphotropic virus type 1 (HTLV-1).
Danish: Efter en influenzavaccination kan der forekomme falsk positive serologiske resultater opnået ved ELISA-metoden for antistof mod human immundefektvirus-1 (HIV-1), hepatitis C-virus og især humant T-lymfotropt virus type 1 (HTLV-1).
English: ** geometric mean ratios of SRH
Danish: ** geometriske middelratioer af SRH
English: Allergic reactions may occur following vaccination, in rare cases leading to shock.
Danish: Der kan opstå allergiske reaktioner efter vaccinationen, som i sjældne tilfælde kan medføre shock.
English: Any unused vaccine and waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt vaccine samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: The potential benefits to the mother and risks to the infant should be considered before administering AFLUNOV during breast-feeding.
Danish: De potentielle fordele for moderen og risici for barnet skal overvejes, før AFLUNOV administreres under amning.
English: Data in children and adolescents suggest a slight decrease in side effects after the second dose of the vaccine, with no increase in rates of fever.
Danish: Data for børn og unge antyder et svagt fald i bivirkninger efter den anden dosis af vaccinen, uden øgning i forekomsten af feber.
English: AFLUNOV contains sodium and potassium.
Danish: AFLUNOV indeholder natrium og kalium