FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic children aged 6-12 years old) participated in clinical studies of oseltamivir given for the treatment of influenza.
Danish: I alt 1.473 børn (herunder i øvrigt raske børn i alderen 1-12 år og astmatiske børn i alderen 6-12 år) deltog i kliniske studier af oseltamivir anvendt til behandling af influenza.
English: Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions.
Danish: Der er utilstrækkelige data til rådighed for disse patienter, hos hvem en anden dosering kan være nødvendig på grund af de ikke fuldt udviklede fysiologiske funktioner.
English: The primary efficacy parameter for all of these studies was the incidence of laboratory-confirmed influenza.
Danish: Den primære effektparameter i alle studierne var incidensen af laboratoriebekræftet influenza.
English: Cardiac / respiratory disease
Danish: Hjertesygdomme/luftvejssygdomme
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blistre
English: Most of the patients with oseltamivir-resistant virus were infected with influenza type A and had prolonged viral shedding.
Danish: De fleste af patienterne med oseltamivir-resistent virus blev smittet med influenza type A og var smittebærere i en forlænget periode.
English: Fulminant hepatitis, Hepatic failure, Hepatitis
Danish: Fulminant hepatitis, leversvigt, hepatitis
English: Oseltamivir-resistant viruses isolated from oseltamivir-treated patients and oseltamivir-resistant laboratory strains of influenza viruses have been found to contain mutations in N1 and N2 neuraminidases.
Danish: Oseltamivir-resistente vira isoleret fra oseltamivir-behandlede patienter og oseltamivir-resistente laboratoriestammer af influenzavira er fundet at have mutationer i N1- og N2-neuraminidaser.
English: The indication in infants below the age of 1 is based upon extrapolation of efficacy data from older children and the recommended posology is based upon pharmacokinetic modelling data (see Section 5.2).
Danish: Indikationen til spædbørn under 1 år er baseret på ekstrapolering af virkningsdata fra ældre børn og den anbefalede dosering er baseret på modellering af farmakokinetiske data (se pkt.
English: You must tell your doctor if you are breast-feeding so that your doctor can decide if Ebilfumin is right for you.
Danish: Du skal fortælle det til lægen, hvis du ammer, så lægen kan beslutte, om Ebilfumin er det rigtige til dig.
English: The total volume required is determined by the weight of the patient according to the recommendation in the table below.
Danish: Det påkrævede totale volumen bestemmes ud fra vægten af patienten som anbefalet i tabellen nedenfor.
English: Use of oseltamivir must not affect the evaluation of individuals for annual influenza vaccination.
Danish: Anvendelse af oseltamivir må ikke påvirke vurderingen af den årlige vaccination imod influenza hos den enkelte patient.
English: Extrapolation of the animal data provides estimates of 0.01 mg/day and 0.3 mg/day for the respective compounds.
Danish: Ekstrapolation af data fra dyr estimerer en udskillelse på henholdsvis 0,01 mg/dag og 0,3 mg/dag.
English: • Inflammation of the skin
Danish: • Betændelse/irritation i huden
English: In general, the adverse reaction profile in children with pre-existing bronchial asthma was qualitatively similar to that of otherwise healthy children.
Danish: Generelt svarede bivirkningsprofilen hos børn med allerede eksisterende bronkial astma kvalitativt til bivirkningsprofilen hos i øvrigt raske børn.
English: The active metabolite is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins found on the virion surface.
Danish: Den aktive metabolit er en selektiv hæmmer af influenzavirus-neuraminidaseenzymer, som er glycoproteiner, der findes på virusoverfladen.
English: The primary endpoint in this study was the incidence of laboratory-confirmed clinical influenza as determined by viral culture and/or a four-fold rise in HAI antibodies.
Danish: Det primære endepunkt i dette studie var forekomsten af laboratoriebekræftet klinisk influenza bestemt ved viral kultur og/eller en fire gange stigning i HAI antistoffer (HAI = hæmoglutination inhibition).
English: The safety profile of oseltamivir observed in this study was consistent with that observed in previous clinical trials where oseltamivir was administered for treatment of influenza in nonimmunocompromised patients (otherwise healthy patients or “at risk” patients [i.e., those with respiratory and/or cardiac co-morbidities]).
Danish: Sikkerhedsprofilen for oseltamivir, der blev observeret i dette studie, var i overensstemmelse med det, der blev observeret i tidligere kliniske studier, hvor oseltamivir blev administreret til behandling af influenza hos ikke-immunkompromitterede patienter (ellers raske patienter eller "risiko" patienter [dvs. patienter med respiratoriske og/eller hjerte co-morbiditeter]).
English: Post-exposure prevention: The recommended post-exposure prevention dose of Ebilfumin is:
Danish: Forebyggelse efter udsættelse for smitte: De anbefalede forebyggende doser af Ebilfumin efter udsættelse for smitte er:
English: Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy compounded 6 mg/ml suspension Total volume of compounded suspension to be prepared
Danish: Antal kapsler og volumen af vehikel, som er nødvendig for at tilberede det totale volumen af en apoteksopblandet 6 mg/ml suspension Samlet volumen af opblandet suspension, som skal fremstilles
English: Very limited information is available on children breast-fed by mothers taking oseltamivir and on excretion of oseltamivir in breast milk.
Danish: Der er meget begrænset information tilgængeligt om børn, der er ammet af mødre, der tager oseltamivir, og om udskillelse af oseltamivir i modermælk.
English: Older people and patients with chronic cardiac and/or respiratory disease The population included in the influenza treatment studies is comprised of otherwise healthy adults/adolescents and patients “at risk” (patients at higher risk of developing complications associated with influenza, e.g. older people and patients with chronic cardiac or respiratory disease).
Danish: Ældre personer og patienter med kronisk hjerte- og/eller luftvejssygdom Populationen, som indgår i influenzabehandlingsstudierne, består af i øvrigt raske voksne/unge og patienter ”i risiko” (patienter med en højere risiko for at udvikle komplikationer i forbindelse med influenza, f.eks. ældre personer og patienter med kronisk hjerte-eller luftvejssygdom).
English: Reports of overdoses with oseltamivir have been received from clinical trials and during postmarketing experience.
Danish: Indberetninger om overdosering af oseltamivir er modtaget fra kliniske studier og efter markedsføring.
English: The pharmacy preparation should be preferred to home preparation.
Danish: Apoteksopblanding foretrækkes frem for hjemmeopblanding.
English: If you stop taking Ebilfumin
Danish: Hvis du holder op med at tage Ebilfumin
English: Oseltamivir prophylaxis lasted for 10 days.
Danish: Oseltamivir forebyggelsesbehandling varede i 10 dage.
English: Always complete the course that your doctor prescribed.
Danish: Du skal altid gennemføre den behandling, som lægen har ordineret.
English: • phenylbutazone (used to treat pain and inflammation)
Danish: • phenylbutazon (anvendes ved behandling af smerte og betændelse)
English: The pharmacokinetics of oseltamivir in children and adolescents 12 years of age or older are similar to those in adults.
Danish: Oseltamivirs farmakokinetik hos børn og unge, som er 12 år eller ældre svarer til voksnes.
English: To allow for accurate volume withdrawal of up to 10 doses (2 withdrawals per daily treatment dose for 5 days), the column indicating measurement loss is to be considered for compounding.
Danish: For at muliggøre korrekt afmåling af op til 10 doser (2 dosisafmålinger per døgn i 5 dage) inkluderer den sidste kolonne spild ved afmåling.
English: Open the stated amount of Ebilfumin capsules and transfer the content of each capsule directly to the preserved water in the glass beaker.
Danish: Åbn det angivne antal af Ebilfumin kapsler og tøm indholdet af hver kapsel direkte i det konserverede vand i glasbægeret.
English: • Ebilfumin may be prescribed for adults, adolescents, children and infants (including full-term newborn babies) as preventive treatment in exceptional circumstances - for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.
Danish: • Ebilfumin kan også ordineres til voksne, unge, børn og spædbørn (herunder fuldbårne nyfødte) som forebyggende behandling i usædvanlige situationer, f.eks. under en influenza-pandemi (global epidemi af influenza), og den sæsonbestemte influenzavaccine ikke yder tilstrækkelig beskyttelse.
English: The proportion of patients with secondary infections in the standard dose group and double dose group was comparable (8.2% vs 5.1%).
Danish: Andelen af patienter med sekundære infektioner i standarddosis-gruppen og dobbeltdosisgruppen var sammenlignelige (8,2 % vs 5,1 %).
English: once daily mg per kg = mg for each kilogram of the infant's body weight.
Danish: 3 mg per kg én gang daglig mg per kg = mg for hvert kilogram af barnets vægt.
English: In adults/adolescents, the most commonly reported adverse reactions (ARs) were nausea and vomiting in the treatment studies, and nausea in the prevention studies.
Danish: Hos voksne/unge var de hyppigste bivirkninger kvalme og opkastning i behandlingsstudierne og kvalme i forebyggelsesstudierne.
English: During treatment with Ebilfumin, tell a doctor immediately:
Danish: Under behandling med Ebilfumin skal du omgående fortælle lægen
English: Refer to the table below for the proper dosing instructions.
Danish: Der henvises til nedenstående tabel for korrekte doseringsinstruktioner.
English: Neuropsychiatric events have been reported during administration of oseltamivir in patients with influenza, especially in children and adolescents.
Danish: Der er rapporteret om neuropsykiatriske hændelser under administration af oseltamivir hos patienter med influenza, især hos børn og unge.
English: Treatment: The recommended treatment dose for infants 0 - 12 months of age is 3 mg/kg twice daily.
Danish: Behandling: Den anbefalede behandlingsdosis til 0-12 måneder gamle spædbørn, er 3 mg/kg to gange daglig.
English: Bronchitis, Herpes simplex, Nasopharyngitis, Upper respiratory tract infections, Sinusitis
Danish: Bronkitis, herpes simplex, nasofaryngitis, infektioner i øvre luftveje, sinuitis
English: When side effects were reported, they were similar to those from normal doses, as listed in section 4.
Danish: Når bivirkninger blev rapporteret, svarede de til bivirkningerne efter normale doser, som angivet i punkt 4.
English: • Ebilfumin is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza).
Danish: • Ebilfumin anvendes til voksne, unge, børn og spædbørn (herunder fuldbårne nyfødte) til at behandle influenza.
English: Posology and method of administration) results in an increased exposure (of up to 50%) to the active metabolite when compared to adult nonimmunocompromised patients with comparable creatinine clearance.
Danish: 4.2 “Dosering og administration”) resulterer i en øget eksponering (op til 50 %) for den aktive metabolit sammenlignet med voksne ikke-immunkompromitterede patienter med tilsvarende kreatinin clearance.
English: The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older).
Danish: De rapporterede bivirkninger hos spædbørn i alderen 0 til 12 måneder, svarer for det meste til de bivirkninger, der er rapporteret hos ældre børn (1 år eller ældre).
English: Post-exposure prevention: The recommended prophylaxis dose for infants less than 1 year of age during a pandemic influenza outbreak is half of the daily treatment dose.
Danish: Forebyggelse efter udsættelse af smitte: Den anbefalede profylaktiske dosis til spædbørn under 1 år, under et pandemisk influenzaudbrud, er halvdelen af den daglige behandlingsdosis.
English: Influenza is associated with adverse pregnancy and foetal outcomes, with a risk of major congenital malformations, including congenital heart defects.
Danish: Influenza er forbundet med skadelige virkninger under graviditet og hos fosteret med en risiko for store medfødte misdannelser, inklusiv medfødte hjertefejl.
English: • Convulsions and delirium, including altered level of consciousness
Danish: • kramper og febervildelse (inklusiv ændret bevidsthedsniveau)
English: Hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with influenza-like illness.
Danish: Lidelser i det hepatobiliære system, herunder hepatitis og forhøjede leverenzymer hos patienter med influenzalignende sygdom.
English: Mix the sweet food and Ebilfumin suspension well.
Danish: Bland den søde fødevare og Ebilfumin suspension grundigt.
English: Conjunctivitis (including red eyes, eye discharge and eye pain)
Danish: Konjunktivitis (herunder røde øjne, øjenflåd og øjensmerter)
English: However, the duration of treatment of influenza in immunocompromised adult patients should be 10 days, as there are no studies of a shorter course of oseltamivir in this patient group (see section 5.1).
Danish: Dog bør behandlingen hos immunkomprimerede patienter vare i 10 dage, da der ikke findes studier med kortere varighed af oseltamivir behandling hos denne patientgruppe (se pkt.
English: Infants less than 1 year (0 to 12 months)
Danish: Spædbørn under 1 år (0 til 12 måneder)
English: Considering the margins of exposure in relation to the expected exposure in the human use, these findings do not change the benefit-risk of oseltamivir in its adopted therapeutic indications.
Danish: Betragtes margin for eksponering i forhold til den forventede humane eksponering, ændrer disse resultater ikke på forholdet mellem fordele og ulemper for oseltamivir og dets godkendte indikationer.
English: Oseltamivir given orally inhibits influenza A and B virus replication and pathogenicity in vivo in animal models of influenza infection at antiviral exposures similar to that achieved in man with 75 mg twice daily.
Danish: Oseltamivir oralt hæmmer replikation og patogenicitet af influenzavirus A og B in vivo i dyremodeller for influenzainfektion efter antiviral eksponering svarende til 75 mg to gange daglig til mennesker.
English: 137.5 ml (or 150 ml)*
Danish: 137,5 ml (eller 150 ml)*
English: Influenza, usually called flu, is an infection caused by a virus.
Danish: Influenza er en infektion forårsaget af en virus.
English: Exposure does not exceed that for treatment of infants < 1 year (3 mg/kg twice daily) and is anticipated to result in a comparable safety profile (see Section 4.8).
Danish: Eksponeringen overstiger ikke den dosis, som anvendes til behandling af spædbørn <1 år (3 mg/kg to gange dagligt) og forventes at resultere i en sammenlignelig sikkerhedsprofil (se pkt.
English: Antiviral activity of oseltamivir was supported for influenza A and B by experimental challenge studies in healthy volunteers.
Danish: Oseltamivirs antivirale aktivitet overfor influenza A og B blev støttet af eksperimentelle provokationsstudier hos raske, frivillige forsøgspersoner.
English: Treatment and prevention of influenza in children:
Danish: Behandling og forebyggelse af influenza hos børn:
English: ARs are added to the appropriate category in the tables according to the pooled analysis from clinical studies.
Danish: Bivirkningerne er grupperet i tilhørende kategorier i tabellen ud fra samlede analyser fra kliniske studier.
English: In the majority of patients, these ARs did not lead to discontinuation of oseltamivir.
Danish: Hos størstedelen af patienterne førte disse bivirkninger ikke til ophør af behandling med oseltamivir.
English: Adverse reactions according to frequency Very common Common
Danish: Bivirkninger efter hyppighed Meget almindelig Almindelig
English: For treating flu, take two doses daily.
Danish: Du skal tage to doser daglig for at behandle influenza.
English: Infants less than 1 year
Danish: Spædbørn under 1 år
English: The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated in a post-exposure prevention study in households that included adults, adolescents, and children aged 1 to 12 years, both as index cases and as family contacts.
Danish: Effekten af oseltamivir ved forebyggelse af naturligt forekommende influenza er påvist i en posteksponeringsundersøgelse med husstande udsat for smitte, der inkluderede voksne, unge og børn i alderen 1 til 12 år, både som indeks tilfælde og som familiekontakter.
English: There are no data available for infants below 1 year of age for post exposure prevention of influenza.
Danish: Der findes ingen tilgængelige data for spædbørn under 1 år vedrørende forebyggelse af influenza efter udsættelse for smitte.
English: • chlorpropamide (used to treat diabetes)
Danish: • chlorpropamid (anvendes ved behandling af diabetes)
English: Infants and children 1 year of age or older: The pharmacokinetics of oseltamivir have been evaluated in single-dose pharmacokinetic studies in infants, children and adolescents 1 to 16 years of age.
Danish: Spædbørn og børn, som er 1 år eller ældre: Oseltamivirs farmakokinetik er undersøgt i et enkeltdosis farmakokinetisk studie med spædbørn, børn og unge i alderen 1 til 16 år.
English: Whereas very high oral single doses of oseltamivir phosphate salt, up to the highest dose tested (1,310 mg/kg), had no adverse reactions in adult rats, such doses resulted in toxicity in juvenile 7-day- old rat pups, including death.
Danish: Meget høje orale enkeltdoser af oseltamivirphosphatsalt, op til den højeste testede dosis (1.310 mg/kg), forårsagede ingen bivirkninger hos voksne rotter, men resulterede derimod i toksicitet, herunder dødsfald, hos juvenile 7 dage gamle rotteunger.
English: Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.
Danish: Der er påvist effekt, når behandlingen er påbegyndt inden for to dage efter symptomernes start.
English: You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if Ebilfumin is right for you.
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, så lægen kan beslutte, om Ebilfumin er det rigtige til dig.
English: The study included solid organ transplant [SOT] patients, haematopoietic stem cell transplant [HSCT] patients, HIV positive patients with a CD4+ cell count <500 cells/mm3, patients on systemic immunosuppressive therapy, and those with haematological malignancy.
Danish: Studiet inkluderede patienter transplanteret med solide organer, patienter med hæmatopoietisk stamcelletransplantation, HIV-positive patienter med CD4+ celletal <500 celler/mm3, patienter i systemisk immunsuppressiv behandling og patienter med hæmatologisk malignitet.
English: Based on preclinical data, there is no evidence that oseltamivir has an effect on male or female fertility (see section 5.3).
Danish: Baseret på prækliniske data er der intet som tyder på, at oseltamivir påvirker fertiliteten hos mænd eller kvinder (se pkt.
English: Ebilfumin contains sodium
Danish: Ebilfumin indeholder natrium
English: How much mixture to draw up
Danish: Volumen af blanding, som skal trækkes op
English: There is no evidence for efficacy of oseltamivir in any illness caused by agents other than influenza viruses (see section 5.1).
Danish: Der er ikke tegn på effekt af oseltamivir ved sygdomme forårsaget af andet end influenzavirus (se pkt.5.1).
English: No dose adjustment is required when co-administering with probenecid in patients with normal renal function.
Danish: Dosisjustering er ikke nødvendigt, når oseltamivir gives sammen med probenecid til patienter med normal nyrefunktion.
English: Oseltamivir is not a substitute for influenza vaccination
Danish: Oseltamivir er ikke en erstatning for influenzavaccination
English: The signs of flu often include a sudden fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness.
Danish: Symptomerne på influenza omfatter ofte pludseligt indsættende feber (over 37,8 °C), hoste, næse der løber eller er stoppet, hovedpine, muskelsmerter og ekstrem træthed.
English: • Ebilfumin can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis - for instance, if you have been in contact with someone who has flu.
Danish: • Ebilfumin kan også i enkelte tilfælde ordineres til voksne, unge, børn og spædbørn over 1 år for at forebygge influenza, f.eks. hvis du har været i kontakt med personer, som har influenza.
English: Gastrointestinal disorders
Danish: Gastrointestinal
English: Clinical and surveillance data: Natural mutations associated with reduced susceptibility to oseltamivir in vitro have been detected in influenza A and B viruses isolated from patients without exposure to oseltamivir.
Danish: Kliniske data og data fra overvågning: Naturligt forekommende mutationer forbundet med nedsat følsomhed over for oseltamivir in vitro er set i influenza A- og B-vira isoleret fra patienter, som ikke har været udsat for oseltamivir.
English: [Only applicable for outer packaging:] 2D barcode carrying the unique identifier included.
Danish: [Gælder kun for ydre karton:] Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: On the basis of drug exposure and tolerability, dosage adjustments are not required for older people unless there is evidence of moderate or severe renal impairment (creatinine clearance below 60 ml /min) (see section 4.2).
Danish: På baggrund af eksponeringen og tolerabiliteten af præparatet er justering af dosis ikke nødvendig hos ældre personer med mindre der er tegn på moderat eller svært nedsat nyrefunktion (creatininclearance under 60 ml/min.)
English: Throw away any unused liquid left in the first bowl.
Danish: Kassér al ubrugt væske, som er tilbage i den første skål.
English: Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established.
Danish: Effekten af oseltamivir til behandling af patienter med kroniske hjertesygdomme og/eller luftvejssygdomme er ikke dokumenteret.
English: Oseltamivir phosphate inhibits influenza virus infection and replication in vitro.
Danish: Oseltamivirphosphat hæmmer influenzavirus infektion og replikation in vitro.
English: These patients were randomized to be treated, within 96 hours of symptoms onset, with standard dose (73 patients) or double dose (78 patients) of oseltamivir, for a duration of 10 days.
Danish: Disse patienter blev randomiseret til behandling inden for 96 timer fra indtræden af symptomer, med standarddosis (73 patienter) eller dobbeltdosis (78 patienter) af oseltamivir i en varighed på 10 dage.
English: Dispense the pharmacy compounded suspension with a graduated oral syringe for measuring small amounts of suspension.
Danish: Doser den apoteksopblandede suspension med en inddelt oral sprøjte, der kan måle små mængder suspension.
English: Infants less than 1 year To make a smaller single dose, you need:
Danish: Spædbørn under 1 år For at tilberede en mindre enkeltdosis, skal du bruge:
English: Oseltamivir phosphate is a pro-drug of the active metabolite (oseltamivir carboxylate).
Danish: Oseltamivirphosphat er et prodrug for den aktive metabolit (oseltamivircarboxylat).
English: Stir the mixture with the teaspoon for about 2 minutes.
Danish: Rør blandingen med en teske i ca. 2 minutter.