FrancophonIA/ELRC3.0 huggingface dataset:
English: Furthermore, Idelvion was effective in treating bleeding episodes when they did occur; around 93% of the bleeding episodes resolved with one Idelvion injection.
Danish: Desuden var Idelvion effektivt til behandling af de blødningsepisoder, der forekom; ca. 93 % af blødningsepisoderne blev afhjulpet med én injiceret dosis Idelvion.
English: What is Idelvion and what is it used for?
Danish: Hvad er Idelvion, og hvad anvendes det til?
English: It can be used in patients of all ages.
Danish: Idelvion kan anvendes til patienter i alle aldre.
English: Hypersensitivity (allergic) reactions can occur rarely with Idelvion and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Danish: Disse omfatter: hævelse, brændende og stikkende fornemmelse på injektionsstedet, kulderystelser, hedeture, kløende udslæt, hovedpine, nældefeber, lavt blodtryk, sløvhed, kvalme og opkastning, rastløshed, hurtig hjerterytme, trykken for brystet og hvæsende vejrtrækning.
English: It is not intended to provide practical advice on how to use Idelvion.
Danish: Det er ikke en praktisk vejledning i, hvordan Idelvion bør anvendes.
English: What are the risks associated with Idelvion?
Danish: Hvilke risici er der forbundet med Idelvion?
English: Studies show that Idelvion is effective at preventing and treating bleeding episodes in patients with haemophilia B, and its safety is comparable to that of other factor IX products.
Danish: Undersøgelser har vist, at Idelvion er effektivt til at forebygge og behandle blødningsepisoder hos patienter med hæmofili B, og sikkerheden ved lægemidlet er sammenlignelig med sikkerheden ved andre faktor IX-lægemidler.
English: For more information about treatment with Idelvion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Idelvion, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For the full list of side effects reported with Idelvion, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Idelvion fremgår af indlægssedlen.
English: Idelvion is available as powder and solvent that are mixed together to make a solution for injection into a vein.
Danish: Idelvion leveres som et pulver med opløsningsvæske (solvens), der blandes sammen til en opløsning, som gives ved injektion i en vene.
English: For further information on how to use this medicine, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Idelvion fremgår af produktresuméet (også en del af denne EPAR).
English: Idelvion is a medicine used to prevent and treat bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Danish: Idelvion er et lægemiddel til forebyggelse og behandling af blødning ved den arvelige blødningsforstyrrelse hæmofili B, der skyldes mangel på blodstørkningsproteinet faktor IX.
English: For practical information about using Idelvion, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Idelvion, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Idelvion contains the active substance albutrepenonacog alfa.
Danish: Det indeholder det aktive stof albutrepenonacog alfa.
English: How is Idelvion used?
Danish: Hvordan anvendes Idelvion?
English: What benefits of Idelvion have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Idelvion?
English: How does Idelvion work?
Danish: Hvordan virker Idelvion?
English: Give the child something to drink.
Danish: Giv barnet noget at drikke.
English: The difference is how often it is given.
Danish: Forskellen er, hvor ofte det tages.
English: Not recommended (no data available)
Danish: Anbefales ikke (ingen data tilgængelig)
English: (nearest)
Danish: (nærmeste)
English: It is usually convenient to take one dose in the morning and one in the evening.
Danish: Det er normalt passende at tage en dosis om morgenen og en om aftenen.
English: This is usually suitable for children over 1 year.
Danish: Dette er oftest passende for børn over 1 år.
English: Date of first authorisation: 22 May 2014 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 22 maj 2014 Dato for seneste fornyelse:
English: These symptoms can also be caused by other infections.
Danish: Disse symptomer kan også skyldes andre infektioner.
English: Specific studies have not been conducted to assess the reduction in the risk of complications.
Danish: Der er ikke udført specifikke studier om reduktion af risikoen for komplikationer.
English: • if you are allergic to other medicines
Danish: • hvis du er allergisk over for anden medicin
English: The following medicines are particularly important:
Danish: Det er særdeles vigtig at fortælle om de følgende lægemidler:
English: Povidone (K-29/32)
Danish: Povidon (K-29/32)
English: These may be signs of rare but serious side effects.
Danish: Dette kan være tegn på sjældne, men alvorlige bivirkninger.
English: Repeat this procedure every time you need to give the medicine.
Danish: Gentag denne procedure, hver gang du skal give medicinen.
English: • if your immune system is not working
Danish: • hvis dit immunforsvaret ikke virker
English: It is best to take this in the mornings with breakfast.
Danish: Det er bedst at tage denne dosis om morgenen sammen med morgenmad.
English: The capsule contains a white granulated powder.
Danish: Kapslen indeholder et hvidt granuleret pulver.
English: Be careful with the powder, because it may irritate your skin and eyes.
Danish: Vær forsigtig med pulveret, da det kan irritere din hud og dine øjne.
English: 30 mg twice daily * This table is not intended to contain all possible weights for this population.
Danish: 30 mg to gange daglig * Denne tabel indeholder ikke alle vægtmuligheder hos denne population.
English: Pregnant Women
Danish: Gravide kvinder
English: Look up the child's weight on the left side of the table.
Danish: Se efter barnets vægt i venstre side af tabellen.
English: Draw it up carefully so as not to include air bubbles.
Danish: Træk den forsigtigt op, så der ikke kommer luftbobler.
English: (Note: This compounded suspension should be gently shaken prior to administration to minimise the tendency for air entrapment.)
Danish: (Bemærk: Den opblandede suspension bør rystes forsigtigt inden administration for at minimere tendensen til skumdannelse).
English: Many of the side effects listed below may also be caused by influenza.
Danish: Mange af de bivirkninger, som er beskrevet nedenfor, kan også skyldes influenza.
English: • if you have a severe medical condition, which may require immediate hospitalisation
Danish: • hvis du har en alvorlig sygdom, som kan kræve omgående hospitalsindlæggelse
English: Children with pre-existing bronchial asthma
Danish: Børn med allerede eksisterende bronkial astma
English: Metabolite exposures are also more variable in the youngest infants.
Danish: Eksponeringen for metabolitten er også mere variabel hos de yngste spædbørn.
English: • if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents.
Danish: • hvis du lægger mærke til ændringer i adfærd eller humør (neuropsykiatriske hændelser), især hos børn og unge.
English: The undissolved powder is just inactive ingredients.
Danish: Det ikke opløste pulver er blot inaktive indholdsstoffer
English: Infants (<1year) * Full genotyping was not performed in all studies.
Danish: Spædbørn (< 1 år) * Fuld genotypetestning blev ikke udført i alle forsøg.
English: In 2008, H275Y was found in > 99 % of circulating H1N1 influenza isolates in Europe.
Danish: I 2008 blev H275Y fundet i > 99% af de cirkulerende H1N1-influenza-isolater i Europa.
English: The contribution of oseltamivir to those events is unknown.
Danish: Oseltamivir bidrag til disse hændelser er ukendt.
English: The frequency of these effects is reduced if the medicinal product is taken with food.
Danish: Hyppigheden af bivirkningerne nedsættes, hvis lægemidlet tages sammen med føde.
English: Reversible irritancy of rabbits' eyes was detected.
Danish: Der blev set reversibel irritation af øjnene hos kanin.
English: • Neuropsychiatric disorders, as described below.
Danish: • Neuropsykiatriske lidelser, som beskrevet nedenfor.
English: Of those, 851 children received treatment with oseltamivir suspension.
Danish: Af disse blev 851 børn behandlet med oseltamivir suspension.
English: The majority of these ARs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days.
Danish: De fleste af disse bivirkninger blev kun rapporteret en enkelt gang, enten på første eller anden behandlingsdag, og forsvandt spontant i løbet af 1-2 dage.
English: • Two small bowls (use separate pairs of bowls for each child)
Danish: • To små skåle (brug et separat sæt skåle til hvert barn)
English: Rare but serious effects: get medical help at once
Danish: Sjældne, men alvorlige bivirkninger; Søg lægehjælp omgående
English: • Patients, especially children and adolescents, should be closely monitored for the behavioural changes described above.
Danish: • Patienter, især børn og unge, bør overvåges nøje for adfærdsændringer, som beskrevet ovenfor.
English: A vaccine gives you antibodies against the virus.
Danish: En vaccine giver dig antistoffer mod virusen.
English: These medicines prevent the flu virus from spreading inside the body.
Danish: Disse lægemidler forhindrer influenzavirus i at sprede sig i kroppen.
English: Make sure you have the right size dispenser.
Danish: Vær sikker på, at du bruger den korrekte størrelse dispenser.
English: - The appropriate use of Ebilfumin for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection.
Danish: - Den korrekte anvendelse af Ebilfumin til forebyggelse af influenza skal afgøres fra tilfælde til tilfælde på grundlag af omstændighederne og den population, som har brug for beskyttelse.
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 for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c(7), i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
Danish: Disse hændelser kan forekomme samtidig med tilfælde med encephalitis eller encephalopati, men kan også forekomme uden åbenlys alvorlig sygdom.
English: Foetal exposure in the rats and rabbits was approximately 15 to 20 % of that of the mother.
Danish: Føtal eksponering hos rotte og kanin var ca. 15 til 20 % af eksponeringen hos moderen.
English: Do not take Ebilfumin.
Danish: Tag ikke Ebilfumin.
English: Shelf life of 6 weeks at 2°C - 8°C.
Danish: Holdbarhed på 6 uger ved 2 °C -8 °C.
English: It is important to complete the whole 5-day course, even if you start to feel better quickly.
Danish: Det er vigtigt at færdiggøre alle 5 dage af kuren, selvom du begynder hurtigt at føle dig raskere.
English: At least 75 % of an oral dose reaches the systemic circulation as the active metabolite.
Danish: Mindst 75 % af en oral dosis når den systemiske cirkulation som den aktive metabolit.
English: The clinical significance of this finding is not clear, as the study had limited power.
Danish: Den kliniske betydning af dette fund er ikke klar, fordi studiet havde begrænset teststyrke.
English: Step 1: Check the dose is correct
Danish: Trin 1: Undersøg om dosis er korrekt
English: Place an appropriate expiration date label according to storage condition (see section 6.3).
Danish: Påsæt en etiket med en passende udløbsdato i henhold til opbevaringsbetingelserne (se pkt.6.3).
English: Approximately 50 % of the animals treated with the unformulated active substance showed erythema after challenging the induced animals.
Danish: Ca. 50 % af dyrene, som behandledes med det uformulerede aktive stof fik erytem efter provokation af de testede dyr.
English: The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations.
Danish: Anvendelsen af antivirale lægemidler til behandling og forebyggelse af influenza skal besluttes på grundlag af officielle anbefalinger.
English: The mixture must be swallowed immediately after its preparation.
Danish: Blandingen skal sluges straks efter opblanding.
English: The indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A.
Danish: Indikationen er baseret på kliniske studier på naturligt optrædende influenza, hvor den dominerende infektion var influenza A.
English: It is recommended that this information be provided by either affixing an ancillary label to the bottle or adding a statement to the pharmacy label instructions.
Danish: Det anbefales, at denne information gives ved enten at sætte en ekstra etiket på flasken eller ved at tilføje det til instruktionerne på apotekets etiket.
English: Before you take Ebilfumin, make sure the prescribing doctor knows
Danish: Før du tager Ebilfumin, skal du sikre dig, at den receptudstedende læge ved
English: Talk to your doctor if this applies to you.
Danish: Tal med lægen, hvis ovenstående gælder dig.
English: Pour all of the powder into the bowl, whatever the dose you are making.
Danish: Hæld alt pulveret ned i skålen, uanset hvilken dosis du skal lave.
English: Patients should be closely monitored for behavioural changes, and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see section 4.8).
Danish: Patienter bør overvåges omhyggeligt for adfærdsændringer, og fordele og risici ved fortsættelse af behandlingen bør vurderes omhyggeligt for hver enkelt patient (se pkt.
English: The active metabolite is eliminated entirely by renal excretion.
Danish: Den aktive metabolit elimineres fuldstændigt ved renal udskillelse.
English: The recommended dose is based on the patient's body weight.
Danish: Den anbefalede dosis er baseret på patientens vægt.
English: It is not further metabolised and is eliminated in the urine.
Danish: Det metaboliseres ikke yderligere og udskilles i urinen.
English: These side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues.
Danish: For det meste optræder disse bivirkninger kun efter første dosis af medicinen og forsvinder normalt, når behandlingen fortsættes.
English: This leaflet was last revised in {MM/YYYY} {month YYYY}.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: Look at the right column to check the number of capsules you will need to give the patient for a single dose.
Danish: Se i den højre kolonne for at finde det antal kapsler, som du skal bruge for at give patienten en enkelt dosis.
English: The reported adverse events were consistent with the established safety profile in older children.
Danish: De rapporterede bivirkninger var konsistente med den etablerede sikkerhedsprofil hos ældre børn.
English: These reactions were seen at doses of 657 mg/kg and higher.
Danish: Denne virkning forekom ved doser på 657 mg/kg og højere.
English: Dermatitis (including allergic and atopic dermatitis)
Danish: Dermatitis (herunder allergisk og atopisk dermatitis)
English: • Water
Danish: • Vand
English: General Information
Danish: Generel information
English: Use the appropriate size capsule instead.
Danish: Brug den egnede størrelse i stedet.
English: Instruct the parent or caregiver that any remaining material following completion of therapy must be discarded.
Danish: Instruer forælder eller omsorgsperson i, at al resterende medicin skal kasseres efter afsluttet behandling.
English: In special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks.
Danish: I særlige tilfælde, såsom ved udbredt influenza eller hos patienter med nedsat immunforsvar, vil behandlingen fortsætte i op til 6 eller 12 uger.
English: Half-lives observed in older people were similar to those seen in young adults.
Danish: De observerede halveringstider hos ældre personer svarede til dem som er set hos unge voksne.
English: Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.
Danish: Uden for perioder med epidemier skyldes influenza-lignende symptomer sædvanligvis andre sygdomme.
English: Exposure to the pro-drug is less than 5 % relative to the active metabolite.
Danish: Eksponeringen for prodrug er mindre end 5 % i forhold til den aktive metabolit.
English: See Section 5.2 for exposure simulation details.
Danish: 5.2 for detaljer for simulering af eksponering.
English: Clinical studies
Danish: Kliniske studier:
English: • if you have chronic heart disease or respiratory disease.
Danish: • hvis du har kronisk hjertesygdom eller luftvejssygdom.
English: If so, your dose may need adjustment
Danish: Hvis det er tilfældet, kan der være behov for dosisjusteringer.
English: Stop taking Ebilfumin and contact a doctor or pharmacist immediately.
Danish: Stop med at tage Ebilfumin og kontakt straks lægen eller apoteket.
English: You will need to prepare a dose of less than 75 mg for children who weigh less than 40 kg. See below.
Danish: Du skal tilberede en dosis på mindre end 75 mg til børn som vejer mindre end 40 kg. Se nedenfor.
English: The ARs listed in the tables below fall into the following categories: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Danish: Bivirkningerne som fremgår af nedenstående tabel, opdeles i følgende kategorier: Meget almindelig (≥ 1/10 ), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000).
English: Developing oseltamivir-resistant virus during treatment was more frequent in children than adults, ranging from less than 1% in adults to 18% in infants aged below 1 year.
Danish: Udvikling af oseltamivirresistent virus under behandling var mere hyppig hos børn end voksne, der spænder fra mindre end 1 % hos voksne til 18 % hos spædbørn under 1 år.
English: The susceptibility to oseltamivir and the prevalence of such viruses appear to vary seasonally and geographically.
Danish: Følsomheden over for oseltamivir og prævalensen af sådanne vira synes at variere sæsonmæssigt og geografisk.
English: * Depending on the capsule strength used.
Danish: * Afhængigt af hvilken kapselstyrke der anvendes.
English: Oseltamivir resistance
Danish: Oseltamivir resistens
English: Incidence of Oseltamivir Resistance in Clinical Studies Patient Population
Danish: Forekomst af oseltamivir resistens i kliniske studier Patientpopulation
English: Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist.
Danish: Metoden kan ændres fra APD til CAPD, hvis en nefrolog anser det for nødvendigt.
English: Immunocompromised patients and young children are at a higher risk of developing oseltamivir-resistant virus during treatment.
Danish: Immunkompromitterede patienter og mindre børn har højere risiko for at udvikle oseltamivir-resistent virus under behandling.
English: Since 2007 naturally occurring resistance associated with the H275Y mutation in seasonal H1N1 strains has been sporadically detected.
Danish: Siden 2007 er naturligt forekommende resistens forbundet med H275Y-mutationen i sæsonbestemte H1N1-stammer blevet sporadisk detekteret.
English: Swallow the capsules whole with water.
Danish: Du skal sluge kapslerne hele med vand.
English: The binding of the oseltamivir carboxylate to human plasma protein is negligible (approximately 3 %).
Danish: Bindingen af oseltamivircarboxylat til human plasmaprotein er ubetydelig (ca. 3 %).
English: See section 4.2 for information on paediatric use.
Danish: 4.2 for information om pædiatrisk anvendelse.
English: Statistical analyses are therefore presented only for influenza-infected subjects.
Danish: Der præsenteres derfor kun statistiske analyser for influenzasmittede patienter.
English: 0 - 12 months
Danish: 0 - 12 måneder
English: Amount of Ebilfumin suspension
Danish: Volumen af Ebilfuminsuspension
English: A funnel may be used to eliminate any spillage.
Danish: En tragt kan anvendes for at hindre spild.
English: Do not take a double dose to make up for a forgotten capsule.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: A second study was completed in 334 asthmatic children aged 6 to 12 years old of which 53.6 % were influenza-positive.
Danish: Et andet studie fuldførtes hos 334 astmatiske børn i alderen 6 til 12 år, af hvilke 53,6 % var smittet med influenza.
English: Multiple-dose pharmacokinetics were studied in a small number of children enrolled in a clinical efficacy study.
Danish: Multipel dosisfarmakokinetik undersøgtes hos et mindre antal børn, som indgik i et klinisk effektstudie.
English: The following serious side effects have been rarely reported since oseltamivir has been marketed:
Danish: Følgende alvorlige bivirkninger er blevet rapporteret sjældent efter markedsføring af oseltamivir:
English: The virulence of influenza epidemics is not predictable and varies within a region and from season to season, therefore the number needed to treat (NNT) in order to prevent one case of influenza illness varies.
Danish: Virulensen af influenzaepidemier kan ikke forudsiges og varierer i et område og fra sæson til sæson, hvorfor det nødvendige antal personer, som skal behandles for at forebygge et influenzatilfælde (NNT), varierer.
English: Viral neuraminidase enzyme activity is important both for viral entry into uninfected cells and for the release of recently formed virus particles from infected cells, and for the further spread of infectious virus in the body.
Danish: Den virale neuraminidaseaktivitet er vigtig både for viral indgang i uinficerede celler og for frigørelsen af de nydannede viruspartikler fra inficerede celler og for den videre spredning af det infektiøse virus i kroppen.
English: In the overall treatment population, influenza infection was confirmed in 67 % (range 46 % to 74 %) of the recruited patients.
Danish: I den samlede behandlingspopulation blev influenza bekræftet hos 67 % (spændvidde: 46 % - 74 %) af de rekrutterede patienter.
English: The total duration of fever was reduced by one day in the groups treated with oseltamivir.
Danish: Den samlede varighed af feber nedsattes med en dag i de grupper, som fik oseltamivir.
English: Add the water to the powder in the bowl.
Danish: Tilsæt vandet til pulveret i skålen.
English: The 2009 H1N1 influenza (“swine flu”) was almost uniformly susceptible to oseltamivir, with only sporadic reports of resistance in connection with both therapeutic and prophylactic regimens.
Danish: H1N1-influenzaen i 2009 (”svineinfluenza”) var næsten ensartet følsom over for oseltamivir, med blot sporadiske rapporter om resistens i forbindelse med både terapeutiske og profylaktiske behandlinger.
English: Put an ancillary label on the bottle indicating “Shake Gently Before Use”.
Danish: Sæt en ekstra etiket på flasken med teksten ”Ryst forsigtigt før brug”.
English: Hafnarfjörður Iceland
Danish: Hafnarfjörður Island
English: There was no resistance observed during a 12-week prophylaxis study in immunocompromised patients.
Danish: Der blev ikke observeret resistens under et 12 ugers profylaksestudie i immunkompromitterede patienter.