FrancophonIA/ELRC3.0 huggingface dataset:
English: Younger children cleared both the pro-drug and its active metabolite faster than adults, resulting in a lower exposure for a given mg/kg dose.
Danish: Yngre børn udskilte både prodrug'en og dens aktive metabolit hurtigere end voksne, resulterende i en lavere eksponering for en given mg/kg-dosis.
English: Influenza was confirmed in 163 out of 377 index cases.
Danish: Influenza blev bekræftet hos 163 af 377 personer med symptomer på influenza.
English: Step 3: Choose the correct amount for your child's weight
Danish: Trin 3: Vælg den korrekte volumen ud fra barnets vægt
English: People who find it hard to take capsules can use a liquid form of this medicine (oral suspension).
Danish: Personer, som har svært ved at sluge kapsler, kan anvende medicinen i flydende form (oral suspension).
English: The column on the right of the table shows how much of the liquid mixture you will need to draw up.
Danish: Kolonnen til højre i tabellen viser volumen af blanding, som du skal trække op.
English: In both cases, the correct volumes should preferably be marked on the dispensers.
Danish: I begge tilfælde skal de korrekte volumener helst være markeret på dispenserne.
English: The mixture should be stirred and given entirely to the patient.
Danish: Blandingen skal omrøres og det hele gives til patienten.
English: Recommended dose for prevention
Danish: Anbefalet dosis til forebyggelse
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity and genotoxicity.
Danish: Prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: For example: If a 6-month-old weighs 8 kg, the dose is 8 kg x 3mg per kg = 24 mg
Danish: F.eks.: Hvis et 6 måneder gammelt barn vejer 8 kg, er dosis 8 kg x 3 mg per kg=24 mg
English: Step 5: Sweeten and give to the child
Danish: Trin 5: Tilsæt sødemiddel og giv til barnet
English: The median duration of illness in influenza B infected subjects did not differ significantly between the treatment groups in individual studies.
Danish: Den mediane sygdomsvarighed hos de influenza B inficerede patienter var ikke signifikant forskellig mellem behandlingsgrupperne i de enkelte studier.
English: Don't worry if not all of the powder dissolves.
Danish: Vær ikke bekymret, hvis noget af pulveret fra kapslen ikke opløses.
English: Draw up the correct amount of liquid mixture from the first bowl.
Danish: Træk den korrekte volumen af blanding op fra den første skål.
English: The rate of clearance of the active metabolite, corrected for bodyweight, decreases with ages below one year.
Danish: Clearancehastigheden af den aktive metabolit, korrigeret for legemsvægt, nedsættes ved alder under 1 år.
English: True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community.
Danish: Rigtig influenza optræder kun i årlige udbrud (epidemier) på tidspunkter, hvor influenzavira er spredt blandt lokalbefolkningen.
English: What you need to know before you take Ebilfumin Do not take Ebilfumin:
Danish: Det skal du vide, før du begynder at tage Ebilfumin Tag ikke Ebilfumin :
English: The European Medicines Agency has deferred the obligation to submit the results of studies with oseltamivir in one or more subsets of the paediatric population in influenza.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne fra studier med Ebilfumin i en eller flere undergrupper af den pædiatriske population ved influenza.
English: Required volume of vehicle
Danish: Volumen af vehikel
English: Of the older subjects, 64 % were influenza-positive and of those with chronic cardiac and/or respiratory disease 62 % were influenza-positive.
Danish: Af de ældre patienter var 64 % influenza-positive og af de der havde kronisk hjerte- og/eller luftvejslidelse var 62 % influenza-positive.
English: Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle.
Danish: Overfør suspensionen til et brunt glas eller en brun polyethylenterephthalat (PET) flaske.
English: Ebilfumin hard capsules are bioequivalent formulations.
Danish: Ebilfumin, hårde kapsler er bioækvivalente formuleringer.
English: The lower predicted exposure however, remains above inhibitory concentrations (IC95 values) and at a therapeutic level for a range of influenza virus strains.
Danish: Den laveste forventede eksponering holder sig dog stadig over de hæmmende koncentrationer (IC95- værdier) og på et terapeutisk niveau for en række influenzastammer.
English: Pregelatinised starch (derived from maize starch) Talc
Danish: Prægelatineret stivelse (udvundet af majsstivelse) Talcum
English: Not for children who weigh less than 40 kg
Danish: Ikke til børn som vejer mindre end 40 kg.
English: In addition, there is evidence from observational studies showing benefit of the current dosing regimen in this patient population.
Danish: Desuden er der fra observationsstudier evidens for, at der er fordele ved at bruge det aktuelle doseringsregime hos denne patientpopulation.
English: PVC/PE/PVdC/Al blisters or HDPE containers with LDPE lid (and a desiccant).
Danish: PVC/PE/PVdC/Al blistre eller HDÅE-beholdere med LDPE-låg (og et tørremiddel).
English: Ask your doctor or pharmacist for advice before taking this medicine.
Danish: Spørg din læge eller apoteket til råds, før du tager dette lægemiddel.
English: Resistance mutations tend to be viral sub-type specific.
Danish: Resistensmutationer er ofte viralt subtype-specifikke.
English: Clinically important drug interactions involving competition for renal tubular secretion are unlikely, due to the known safety margin for most of these substances, the elimination characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of these pathways.
Danish: Klinisk signifikante lægemiddelinteraktioner, som involverer kompetetiv konkurrence om den renale tubulære sekretion, er usandsynlige på grund af den kendte sikkerhedsmargin for de fleste af disse stoffer, den aktive metabolits eliminationskarakteristika (glomerulær filtration og anionisk tubulær sekretion) og kapaciteten af disse udskillelsesveje.
English: No effects on foetal development were observed.
Danish: Der blev ikke set effekt på føtal udvikling.
English: Place a pharmacy label on the bottle that includes the patient's name, dosing instructions, use by date, name of medicinal product and any other required information to be in compliance with local pharmacy regulations.
Danish: På flasken anbringes en apoteksetiket, der oplyser om patientens navn, doseringsinstruktioner, sidste anvendelsesdato, lægemiddelnavn og enhver anden information krævet for at overholde lokale apoteksbestemmelser.
English: For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Ebilfumin-water mixture.
Danish: Til hjemmeopblanding bør der sørges for forskellige dispensere til henholdsvis at udtage det korrekte volumen vand og at afmåle Ebilfumin-vand-blandingen.
English: Give the whole contents of the bowl to the patient straight away.
Danish: Giv straks patienten hele indholdet af skålen.
English: Additionally, this study was too small to reliably assess individual types of major malformations; moreover women exposed to oseltamivir and women unexposed could not be made fully comparable, in particular whether or not they had influenza.
Danish: Derudover var der for få deltagere i studiet for med sikkerhed at vurdere de individuelle typer af store misdannelser og yderligere kunne gruppen af kvinder eksponeret for oseltamivir ikke sammenlignes fuldstændigt med gruppen af ueksponerede kvinder og slet ikke i forhold til, om de havde haft influenza eller ej.
English: The protection against influenza lasts only as long as oseltamivir is administered.
Danish: Beskyttelsen imod influenza varer kun så længe, som der gives oseltamivir.
English: No difference in the incidence of complications was observed between the treatment and placebo groups in this population (see section 5.1).
Danish: Der var ingen forskel i hyppighed af komplikationer mellem behandlingsgruppen og placebogruppen hos denne population (se pkt.
English: Step 2: Add water to dilute the medicine
Danish: Trin 2: Tilsæt vand til at fortynde medicinen
English: Treatment and prevention of influenza in adults and adolescents:
Danish: Behandling og forebyggelse af influenza hos voksne og unge:
English: This pharmacy preparation is the preferred option.
Danish: En apoteksopblandet suspension er det foretrukne valg.
English: In the pooled treatment study population, which included both influenza-positive and -negative subjects (ITT), primary efficacy was reduced proportionally to the number of influenza-negative individuals.
Danish: I den samlede behandlingspopulation, som omfattede både influenza-positive og -negative personer, reduceredes den primære effekt proportionalt med antallet af ikke smittede personer (ITT).
English: Due to the wide safety margin of the active metabolite, no dose adjustments are required in adults due to their immunocompromised status.
Danish: På grund af den aktive metabolits brede sikkershedsmargen er der ikke behov for dosisjusteringer hos voksne immunkompromitterede patienter.
English: Reykjavíkurvegi 76-78, 220 Hafnarfjörður Iceland
Danish: Reykjavíkurvegi 76-78, 220 Hafnarfjörður Island
English: The appropriate dispenser sizes for taking the correct volume of Ebilfumin suspension (6 mg/ml) are shown below.
Danish: Den passende størrelse på dispenser for at udtage den korrekte volumen af Ebilfumin suspension (6 mg/ml) er vist forneden.
English: The majority of patients that developed resistance were transplant recipients (8/10 patients in the standard dose group and 2/2 patients in the double dose group).
Danish: Størstedelen af patienter, der udviklede resistens, var transplantationsmodtagere (8/10 patienter i standarddosisgruppen og 2/2 patienter i dobbeltdosis-gruppen).
English: Reykjavíkurvegi 76-78 220 Hafnarfjörður Iceland
Danish: Reykjavíkurvegi 76-78 220 Hafnarfjörður Island
English: Children 1 to 12 years Very common side effects
Danish: Børn 1 til 12 år Meget almindelige bivirkninger
English: No phase 2 conjugates of either compound have been identified in vivo.
Danish: In vivo er der ikke identificeret fase 2 konjugater af nogen af stofferne.
English: Ebilfumin is not a vaccine: it treats infection, or prevents the flu virus spreading.
Danish: Ebilfumin er ikke en vaccine, men behandler infektion eller forhindrer influenzavirus i at sprede sig.
English: • Delusions, hallucinations, agitation, anxiety, nightmares These are reported primarily among children and adolescents and often started suddenly and resolved rapidly.
Danish: • vrangforestillinger, hallucinationer, ophidselse, angst, mareridt Disse hændelser blev primært rapporteret hos børn og unge og indtraf ofte pludseligt og var hurtigt overstået.
English: Open a second capsule for a 60 mg dose.
Danish: Åben endnu en kapsel for en dosis på 60 mg.
English: Paediatric population (infants less than one year of age)
Danish: Pædiatrisk population (spædbørn under 1 år)
English: Exposure to the active metabolite at steady state was 25 to 35 % higher in older people (age 65 to 78 years) compared to adults less than 65 years of age given comparable doses of oseltamivir.
Danish: Eksponeringen over for den aktive metabolit i steady state var 25 til 35 % højere hos ældre personer (fra 65 til 78 år) sammenlignet med voksne under 65 år, som tilsvarende doser oseltamivir.
English: • Confusion, abnormal behaviour
Danish: • forvirring, unormal adfærd,
English: Label for HDPE tablet container and outer carton for tablet container and blister
Danish: Etiket på HDPE tabletbeholder og ydre karton til tabletbeholder og blister
English: To find the correct amount to use, find the patient's weight on the left of the table.
Danish: Til at finde den korrekte dosis, som skal anvendes, skal du finde patientens vægt til venstre i tabellen nedenfor.
English: It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
Danish: Det kan anvendes, hvis du har influenza-symptomer, og det er kendt, at influenzavirus er spredt i lokalbefolkningen.
English: Teratology studies have been conducted in rats and rabbits at doses of up to 1,500 mg/kg/day and 500 mg/kg/day, respectively.
Danish: Der er udført teratologiske studier på rotter og kaniner med doser op til henholdsvis 1.500 mg/kg/dag og 500 mg/kg/dag.
English: Treatment of influenza B infection: Overall, 15 % of the influenza-positive population were infected by influenza B, proportions ranging from 1 to 33 % in individual studies.
Danish: Behandling af influenza B: I alt 15 % af den influenza-positive population havde influenza B. I de enkelte studier spændte hyppigheden fra 1 - 33 %.
English: Less than 20 % of an oral radiolabelled dose is eliminated in faeces.
Danish: Mindre end 20 % af en oral, radioaktivt markeret dosis udskilles i fæces.
English: These cases include fatal fulminant hepatitis/hepatic failure.
Danish: Disse tilfælde inkluderer fatal, fulminant hepatitis/leversvigt.
English: Immunocompromised Patients
Danish: Immunkompromitterede patienter
English: Resistant strains selected during oseltamivir treatment have been isolated from both immunocompetent and immunocompromised patients.
Danish: Resistente stammer selekteret under oseltamivir-behandling er blevet isoleret fra både immunkompetente og immunkompromitterede patienter.
English: Treatment: The following weight-adjusted dosing regimens are recommended for treatment of infants and children 1 year of age or older:
Danish: Behandling: Følgende vægtjusterede doser anbefales til behandling af spædbørn og børn, som er 1 år eller ældre:
English: These events were reported primarily among paediatric and adolescent patients and often had an abrupt onset and rapid resolution.
Danish: Disse hændelser er primært indrapporteret hos pædiatriske eller unge patienter og var ofte pludseligt indtrædende og hurtigt overstået.
English: You must use the amount of oral capsules or suspension prescribed by the doctor.
Danish: Du skal anvende det antal kapsler eller den mængde oral suspension, som lægen har ordineret.
English: Plasma concentrations of both pro-drug and active metabolite are proportional to dose and are unaffected by co-administration with food.
Danish: Plasmakoncentrationen af både prodrug og den aktive metabolit er proportional med dosis og påvirkes ikke af indtagelse sammen med mad.
English: Table 2 shows the most frequently reported ARs from paediatric clinical trials.
Danish: Tabel 2 viser de hyppigst rapporterede bivirkninger i pædiatriske kliniske studier.
English: Storage of the pharmacy compounded suspension Shelf life of 3 weeks when stored below 25 °C.
Danish: Opbevaring af apoteksopblandet suspension: Holdbarhed på 3 uger ved opbevaring under 25 °C.
English: Close the bottle using a child-resistant cap.
Danish: Luk flasken med et børnesikret låg.
English: First, calculate the total volume needed to be compounded and dispensed for each patient.
Danish: Beregn først det totale volumen, som der er behov for at opblande og dosere til hver patient.
English: A large amount of data on oseltamivir exposure of pregnant women from post-marketing reports and observational studies (more than 1000 exposed outcomes during the first trimester) indicate no malformative nor feto/neonatal toxicity by oseltamivir.
Danish: En stor mængde af data vedrørende eksponering af oseltamivir hos gravide kvinder indsamlet fra post-marketing og observationsstudier (mere end 1000 eksponerede under første trimester) indikerer ingen misdannelser eller føtal/neonatal toksicitet forårsaget af oseltamivir.
English: A few cases resulted in self-injury, some with fatal outcome.
Danish: I få tilfælde resulterede dette i, at patienten gjorde skade på sig selv, i nogle tilfælde med dødelig udgang.
English: Results of the conventional rodent carcinogenicity studies showed a trend towards a dose-dependent increase in the incidence of some tumours that are typical for the rodent strains used.
Danish: Resultater fra de konventionelle karcinogene studier på gnavere viste en tendens mod en dosisafhængig øgning i udbredelsen af nogle tumorer, som er typiske for den gnaverrace, der blev anvendt.
English: However treatment-emergent resistance to oseltamivir did not affect treatment response and caused no prolongation of influenza symptoms.
Danish: Behandlingsudviklet resistens over for oseltamivir påvirkede dog ikke behandlingsrespons og forårsagede ingen forlængelse af influenzasymptomer.
English: Data from 504 influenza B infected subjects were pooled across all studies for analysis.
Danish: Data fra 504 patienter med influenza B fra alle studier blev sammenlagt til analyse.
English: In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in individuals one year of age or older.
Danish: Undtagelsesvis (fx i tilfælde af en blanding af cirkulerende virusstammer og virusstammer fra vaccine, og i en pandemisk situation) kan sæsonmæssig forebyggelse hos personer, som er 1 år eller ældre, overvejes.
English: Absorbed oseltamivir is primarily (> 90 %) eliminated by conversion to oseltamivir carboxylate.
Danish: Absorberet oseltamivir elimineres primært (> 90 %) ved omdannelse til oseltamivircarboxylat.
English: Peak plasma concentrations of oseltamivir carboxylate decline with a half-life of 6 to 10 hours in most subjects.
Danish: Peak-plasmakoncentrationerne af oseltamivir carboxylat falder med en halveringstid på 6 til 10 timer hos de fleste forsøgspersoner.
English: Limited data demonstrated that oseltamivir and the active metabolite were detected in breast milk, however the levels were low, which would result in a subtherapeutic dose to the infant.
Danish: Begrænsede data viste, at oseltamivir og den aktive metabolit blev fundet i modermælk, dog var niveauerne lave, hvilket ville resultere i en subterapeutisk dosis til spædbarnet.
English: See the upper set of instructions.
Danish: Se den øverste del af vejledningen.
English: In both cases, the correct volumes should preferably be marked on the syringes.
Danish: I begge tilfælde skal de korrekte volumener helst være markeret på sprøjterne.
English: Administration of 100 mg oseltamivir phosphate twice daily for 5 days to patients with various degrees of renal impairment showed that exposure to oseltamivir carboxylate is inversely proportional to declining renal function.
Danish: Administration af 100 mg oseltamivirphosphat to gange daglig i fem dage til patienter med varierende grad af nedsat nyrefunktion har vist at eksponeringen overfor oseltamivircarboxylat er omvendt proportional med faldende nyrefunktion.
English: Cough, Nasal congestion
Danish: Hoste, nasal kongestion
English: At 500 mg/kg, no adverse reactions were seen, including upon chronic treatment (500 mg/kg/day administered from 7 to 21 days post partum).
Danish: Ved 500 mg/kg sås ingen bivirkninger, ej heller ved kronisk behandling (500 mg/ kg/ dag givet fra dag 7 til dag 21 post partum).
English: For people who find it hard to take capsules, including very young children, a liquid medicine may be available.
Danish: Information til brugeren For personer, som har svært ved at sluge kapsler, herunder små børn, kan medicin i flydende form være tilgængelig.
English: Oseltamivir should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community.
Danish: Oseltamivir bør derfor kun anvendes til behandling og forebyggelse af influenza, når pålidelige epidemiologiske data, indikerer, at der er influenza i området.
English: Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway, suggesting that oseltamivir interaction with this pathway is weak.
Danish: Oseltamivir har ingen kinetisk interaktion med amoxicillin, som udskilles via den samme udskillelsesvej, hvilket tyder på, at oseltamivirs interaktion med denne udskillelsesvej er ringe.
English: In the oseltamivir treated group, the median duration of illness was not reduced significantly.
Danish: I oseltamivirgruppen nedsattes den mediane sygdomsvarighed ikke signifikant.
English: Doses of 2 mg/kg give oseltamivir carboxylate exposures comparable to those achieved in adults receiving a single 75 mg dose (approximately 1 mg/kg).
Danish: Doser på 2 mg/kg giver oseltamivircarboxylat-eksponeringer som er sammenlignelige med dem, der opnås hos voksne, som får en enkelt dosis på 75 mg (ca. 1 mg/kg).
English: In all phase III treatment studies, patients were recruited only during the period in which influenza was circulating in the local community.
Danish: Der rekrutteredes kun patienter til behandlingsstudierne i fase III i den periode, hvor der var influenza i lokalområdet.
English: • if you are allergic to oseltamivir or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for oseltamivir eller et af de øvrige indholdsstoffer i Ebilfumin (angivet i punkt 6).
English: Overdose has been reported more frequently for children than adults and adolescents.
Danish: Overdosering er blevet rapporteret hyppigere hos børn end hos voksne og unge.
English: Considering this information, the pathogenicity of the circulating influenza virus strain and the underlying condition of the breastfeeding woman, administration of oseltamivir may be considered, where there are clear potential benefits to breastfeeding mothers.
Danish: Tages denne information, patogeniciteten af den cirkulerende influenzavirusstamme og den ammende kvindes grundlæggende tilstand i betragtning, kan administration af oseltamivir overvejes, når der er klare potentielle fordele for den ammende mor.
English: When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation of Ebilfumin suspension involves additional steps.
Danish: Hvis kun 75 mg kapsler er tilgængelige, og der er brug for doser på 30 mg og 45 mg, involverer tilberedelsen af Ebilfumin suspension yderligere trin.
English: Talk to your doctor or pharmacist before taking Ebilfumin.
Danish: Kontakt lægen eller apoteketspersonalet, før du tager Ebilfumin.
English: Clinical studies: The risk of emergence of influenza viruses with reduced susceptibility or frank resistance to oseltamivir has been examined during Roche-sponsored clinical studies.
Danish: Kliniske studier: Risikoen for udvikling af influenzavira med nedsat følsomhed eller reel resistens over for oseltamivir er blevet undersøgt i Roche-sponsorerede kliniske studier.
English: Information for healthcare professionals only Patients who are unable to swallow capsules:
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale Patienter, som ikke kan sluge kapsler:
English: Decisions regarding the use of oseltamivir for treatment and prophylaxis should take into consideration what is known about the characteristics of the circulating influenza viruses, available information on influenza drug susceptibility patterns for each season and the impact of the disease in different geographical areas and patient populations (see section 5.1).
Danish: Beslutninger vedrørende brug af oseltamivir til behandling og forebyggelse skal tages under hensyntagen til kendskabet til karakteristika af de cirkulerende influenzavira, foreliggende information om influenzalægemidlers følsomhedsmønstre for hver sæson og sygdommens indflydelse i forskellige geografiske områder og på forskellige patientpopulationer (se pkt.
English: The primary efficacy parameter for this study was the incidence of laboratory-confirmed clinical influenza in the households.
Danish: Den primære effektparameter for denne undersøgelse var forekomst af laboratorie-bekræftet klinisk influenza i husstandene.
English: The effects on breast-fed infants are unknown.
Danish: Virkningerne på ammede børn kendes ikke.