FrancophonIA/ELRC3.0 huggingface dataset:
English: The suspension is caused by some of the excipients of Ebilfumin capsules, which are insoluble.)
Danish: At der dannes suspension skyldes, at nogle af hjælpestofferne i Ebilfumin-kapslerne, er uopløselige.)
English: First, calculate the total volume needed to be compounded and dispensed to provide a 5-day course of treatment or a 10-day course of prophylaxis for the patient.
Danish: Beregn først det totale volumen, der er behov for at opblande og dosere til et 5 dages behandlingsforløb eller til et 10 dages profylaktisk forløb for patienten.
English: The number needed to treat (NNT) in contacts of true influenza cases was 10 (95 % CI 9 - 12) and was 16 (95 % CI 15 - 19) in the whole population (ITT) regardless of infection status in the index case.
Danish: Number needed to treat (NNT) i kontakt med ægte influenzatilfælde var 10 (95 % konfidensinterval: 9-12) og 16 (95 % konfidensinterval: 15-19) i hele populationen (ITT), uanset infektionsstatus hos kontaktpersonerne.
English: Recommended dose for 10 days
Danish: Anbefalet dosis i 10 dage
English: • Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour
Danish: • Leversygdomme (voldsom leverbetændelse, leverfunktionsforstyrrelser og gulsot): Gulfarvning af huden og det hvide i øjnene, ændring i farven på afføring, adfærdsændringer
English: Oseltamivir is effective only against illnesses caused by influenza virus.
Danish: Oseltamivir er kun effektivt overfor sygdomme forårsaget af influenzavirus.
English: Suomi/Finland ratiopharm Oy Puh/Tel: +358 (0)20 180 5900
Danish: Ratiopharm Oy Puh/Tel: +358 (0) 20 180 5900
English: Confusion, Delusions, Delirium, Hallucination, Nightmares, Self-injury
Danish: Agitation, abnorm adfærd, angst, forvirring, vrangforestillinger, delirium, hallucinationer, mareridt, selvbeskadigende adfærd
English: 30 mg every second day
Danish: 30 mg hver anden dag
English: Do not use 45 mg capsules
Danish: Brug ikke 45 mg kapsler
English: Other medicines and Ebilfumin
Danish: Brug af anden medicin sammen med Ebilfumin
English: Co-administration of probenecid, a potent inhibitor of the anionic pathway of renal tubular secretion, results in an approximate 2-fold increase in exposure to the active metabolite of oseltamivir.
Danish: Samtidig indtagelse af probenecid, en potent hæmmer af den renale tubulære sekretions anioniske udskillelsesvej, medfører en stigning af eksponeringen for oseltamivirs aktive metabolit til ca. det dobbelte.
English: For children unable to drink from a bowl, spoon-feed or use a bottle to feed the child the remaining liquid.
Danish: Børn, som ikke kan drikke fra en skål, kan mades med ske, ellers kan barnet få resten med en sutteflaske.
English: If there is anything left in the second bowl, rinse the bowl with a small amount of water and get the child to drink it all.
Danish: Hvis der er en noget tilbage i den anden skål, så skyl skålen med en lille smule vand og lad barnet drikke det hele.
English: Oseltamivir is extensively converted to oseltamivir carboxylate by esterases located predominantly in the liver.
Danish: Oseltamivir omdannes overvejende til oseltamivircarboxylat af esteraser som fortrinsvis findes i leveren.
English: Patients with Resistance Mutations (%) Phenotyping* Geno- and Phenotyping*
Danish: Patienter med resistensmutationer (%) Fænotype*
English: Adverse reactions according to frequency
Danish: Bivirkninger efter hyppighed
English: Syringes of appropriate volume and grading should be provided for administering the pharmacy compounded suspension as well as for the procedures involved in the home preparation.
Danish: Sprøjter af passende størrelse og med passende markeringer bør fremskaffes til administration af den apoteksopblandede suspension såvel som til procedurerne involveret i hjemmeopblanding.
English: Detailed information on the home preparation can be found in the package leaflet of Ebilfumin capsules under “Making liquid Ebilfumin at home”.
Danish: Detaljeret information om hjemmeopblanding kan findes i indlægssedlen for Ebilfumin-kapsler under ”Hjemmeopblanding af flydende Ebilfumin”.
English: For measuring 5.0 ml of water, dispensers of 5 ml or 10 ml should be used.
Danish: Til afmåling af 5,0 ml vand skal dispensere på 5 eller 10 ml anvendes.
English: Children who were found to carry oseltamivir-resistant virus in general shed the virus for a prolonged period compared with subjects with susceptible virus.
Danish: Børn, som viste sig at være bærere af oseltamivir-resistent virus, var smittebærere i en længere periode sammenlignet med forsøgspersoner med følsom virus.
English: Ebilfumin 30 mg, 45 mg and 75 mg capsules are available for infants and children 1 year of age or older
Danish: Ebilfumin findes som 30 mg, 45 mg and 75 mg kapsler til spædbørn og børn, som er 1 år eller ældre.
English: In this study, the rate of major congenital heart defects following oseltamivir exposure during the first trimester was 1.76% (7 infants out of 397 pregnancies) compared to 1.01% in unexposed pregnancies from the general population (Odds Ratio 1.75, 95% Confidence Interval 0.51 to 5.98).
Danish: I dette studie var raten, for at få store medfødte hjertefejl efter eksponering af oseltamivir under første trimester, på 1,76 % (7 spædbørn ud af 397 graviditeter) sammenlignet med en rate på 1,01 % hos de ueksponerede graviditeter fra den generelle population (odds ratio 1,75, 95 % konfidensinterval 0,51 til 5,98).
English: Detailed instructions can be found in the package leaflet of Ebilfumin capsules under “Making liquid Ebilfumin at home”.
Danish: Detaljerede instruktioner kan findes i indlægssedlen for Ebilfumin-kapsler under ”Hjemmeopblanding af flydende Ebilfumin”.
English: In patients with influenza who were receiving oseltamivir, there have been postmarketing reports of convulsions and delirium (including symptoms such as altered level of consciousness, confusion, abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases resulting in self-injury or fatal outcomes.
Danish: Hos influenzapatienter, som fik oseltamivir, er der efter markedsføring rapporteret om kramper og delirium (inklusive symptomer såsom ændret bevidsthedsniveau, forvirring, abnorm adfærd, vrangforestillinger, hallucinationer, agitation, angst, mareridt).
English: Recommended dose for 5 days
Danish: Anbefalet dosis i 5 dage
English: A rat fertility study up to a dose of 1,500 mg/kg/day demonstrated no adverse reactions on either sex.
Danish: I et fertilitetsstudie på rotte med en dosis op til 1.500 mg/kg/dag blev der, uanset køn, ikke påvist bivirkninger.
English: These events are also experienced by patients with influenza without oseltamivir administration.
Danish: Disse hændelser opleves også af patienter med influenza, hvor oseltamivir ikke administreres.
English: The use of Ebilfumin may be considered during pregnancy if necessary and after considering the available safety and benefit information (for data on benefit in pregnant women please refer to section 5.1 “treatment of influenza in pregnant women”), and the pathogenicity of the circulating influenza virus strain.
Danish: Anvendelse af Ebilfumin under graviditet kan overvejes, hvis det er nødvendigt, og efter at den tilgængelige sikkerheds- og effektinformation samt patogeniciteten af den cirkulerende influenzavirusstamme, er taget i betragtning (for data vedrørende gavn hos gravide kvinder se pkt.
English: Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of age) and adults with severe renal impairment.
Danish: Dosisjustering er nødvendig både ved behandling og forebyggelse hos unge (13-17 år) og voksne med svært nedsat nyrefunktion.
English: Dermatitis, Rash, Urticaria
Danish: Eksem, dermatitis, udslæt, urticaria
English: To make a 30 mg or a 60 mg dose, you need:
Danish: For at tilberede en 30 eller en 60 mg dosis skal du bruge:
English: Gently squirt the correct dose into the second bowl.
Danish: Tryk langsomt den korrekte dosis ud i den anden skål.
English: Body weight*
Danish: Legemsvægt*
English: The following dosing regimen is recommended for treatment of infants 0 - 12 months of age:
Danish: Følgende doser anbefales til behandling af 0-12 måneder gamle spædbørn:
English: Infants less than 1 year of age: The pharmacokinetics, pharmacodynamics and safety of oseltamivir have been evaluated in two uncontrolled open-label studies including influenza infected children less than one year of age (n=135).
Danish: Spædbørn under 1 år: Farmakokinetikken, farmakodynamikken og sikkerheden af oseltamivir er blevet evalueret i to åbne, ukontrollerede studier med influenzasmittede børn under 1 år (n=135).
English: Prevention during an influenza epidemic in the community: The recommended dose for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks.
Danish: Forebyggelse under en influenzaepidemi i befolkningen: Den anbefalede dosis til forebyggelse af influenza, når der er udbrudt influenza i befolkningen, er 75 mg oseltamivir en gang daglig i op til 6 uger.
English: In two studies to characterise the pharmacokinetics, pharmacodynamics and safety profile of oseltamivir therapy in 135 influenza infected children less than one year of age, the safety profile was similar among age cohorts with vomiting, diarrohea and diaper rash being the most frequently reported adverse events (see section 5.2).
Danish: I to studier, som karakteriserer farmakokinetikken, farmakodynamikken og sikkerhedsprofilen ved oseltamivir-behandling hos 135 influenzasmittede børn under 1 år, var sikkerhedsprofilen sammenlignelig mellem alderskohorterne med opkastning, diarré og bleudslæt som de hyppigst rapporterede bivirkninger (se pkt.
English: Such neuropsychiatric events have also been reported in patients with influenza who were not taking oseltamivir.
Danish: Sådanne neuropsykiatriske hændelser er også blevet rapporteret hos patienter med influenza, som ikke fik oseltamivir.
English: Second, determine the number of capsules and the amount of vehicle (water containing 0.05 % w/v sodium benzoate added as a preservative) that is needed to prepare the total volume (calculated from the table above) of pharmacy compounded 6 mg/ml suspension as shown in the table below:
Danish: Bestem derefter antal kapsler og volumen af vehiklet (vand indeholdende 0,05% w/v natriumbenzoat tilsat som konserveringsmiddel), som kræves for at tilberede det totale volumen (beregnet ud fra tabellen ovenfor) af apoteksopblandet 6 mg/ml suspension, som vist i nedenstående tabel:
English: The median time to resolution of symptoms (TTRS) was similar between the standard dose group (103 hours [90% CI 75.4-110.0]) and double dose group (104 hours [90% CI 65.8-131.0]).
Danish: Mediantiden til ophør af symptomer var lignende mellem standarddosis-gruppen (103 timer [90 % konfidensinterval: 75,4-110,0]) og dobbeltdosis-gruppen (104 timer [90 % konfidensinterval: 65,8-131,0]).
English: The dose is the same for treating or preventing flu.
Danish: Dosis er den samme til behandling og forebyggelse af influenza.
English: Creatinine clearance
Danish: Creatininclearance
English: If you notice any of these symptoms, get medical help immediately.
Danish: Hvis du bemærker nogen af disse symptomer, skal du omgående søge læge eller skadestue.
English: Children 1 to 12 years Body weight
Danish: Børn 1 til 12 år Legemsvægt
English: • methotrexate (used to treat e.g. rheumatoid arthritis)
Danish: • methotrexat (anvendes ved behandling af bl.a. leddegigt (reumatoid artrit))
English: The available data indicates that the exposure following a 3 mg/kg dose in infants 012 months of age provides pro-drug and metabolite exposures anticipated to be efficacious with a safety profile comparable to that seen in older children and adults using the approved dose (see sections 4.1 and 4.2).
Danish: Tilgængelige data indikerer, at eksponeringen efter en dosis på 3 mg/kg hos 0-12 måneder gamle spædbørn giver prodrugog metabolit-eksponeringerm som forventes at være effektive og med en sikkerhedsprofil, som er sammenlignelig med den, som ses hos ældre børn og voksne, som får den godkendte dosis (se pkt.
English: Population pharmacokinetic analysis indicates that treatment of adult immunocompromised patients with oseltamivir (as described in Section 4.2.
Danish: En farmakokinetisk populationsanalyse indikerer, at oseltamivirbehandling af voksne immunkompromitterede patienter (som beskrevet i pkt.
English: • Teaspoon (5 ml spoon) • Water
Danish: • Teske (5 ml ske) • Vand
English: You should use only 75 mg capsules for 75 mg doses.
Danish: Du skal kun bruge 75 mg kapsler til 75 mg dosis.
English: Infants less than 1 year (including full-term newborn babies) Child's weight
Danish: Spædbørn under 1 år (herunder fuldbårne nyfødte) Barnets vægt
English: Adverse events reported following overdose were similar in nature and distribution to those observed with therapeutic doses of oseltamivir, described in section 4.8 Undesirable effects.
Danish: De bivirkninger, der er rapporteret efter overdosering, svarede i karakter og fordeling til de bivirkninger, der er observeret med terapeutiske doser af oseltamivir, som beskrevet i pkt.
English: Table 2 Adverse reactions in studies investigating oseltamivir for treatment and prevention of influenza in children (age/weight-based dosing [30 mg to 75 mg o.d.]) System Organ Class (SOC)
Danish: Tabel 2 Bivirkninger i studier, som undersøger oseltamivir til behandling og forebyggelse af influenza hos børn (alder/vægt baseret dosering [30 mg til 75 mg en gang dagligt]).
English: However, care should be taken when prescribing oseltamivir in subjects when taking co-excreted agents with a narrow therapeutic margin (e.g. chlorpropamide, methotrexate, phenylbutazone).
Danish: Der skal dog udvises forsigtighed, når oseltamivir ordineres til patienter, som samtidigt tager lægemidler med lille terapeutisk bredde, som udskilles via den samme mekanisme (fx chlorpropamid, methotrexat og phenylbutazon).
English: Seasonal prophylaxis: Longer duration of seasonal prophylaxis up to 12 weeks has been evaluated in immunocompromised patients (see sections 4.4, 4.8 and 5.1).
Danish: Sæsonbestemt forebyggelse: Længere varighed af sæsonbestemt forebyggelse i op til 12 uger er blevet evalueret hos immunkompromitterede patienter (se pkt.
English: [Only applicable for outer packaging:] PC: {number}
Danish: [Gælder kun for ydre karton:] PC: {nummer} SN: {nummer} NN: {nummer}
English: Therapy should begin as soon as possible within two days of exposure to an infected individual.
Danish: Behandling skal påbegyndes så hurtigt som muligt indenfor to dage efter kontakt med en smittet person.
English: • if the influenza symptoms get worse or the fever continues tell your doctor as soon as possible.
Danish: Men under alle omstændigheder hvis du eller dit barn gentagne gange bliver syg hvis influenzasymptomerne forværres eller feberen fortsætter så kontakt lægen så hurtigt som muligt
English: If the commercially manufactured oseltamivir powder for oral suspension and the pharmacy compounded suspension is also not available, Ebilfumin suspension may be prepared at home.
Danish: Hvis at hverken fabriksfremstillet oseltamivir pulver til oral suspension og en apoteksopblandet suspension heller ikke er tilgængelig, kan Ebilfumin suspension tilberedes hjemme.
English: Please use alternative capsule strength*
Danish: Anvend en anden kapselstyrke*
English: Post-exposure prevention: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days for adolescents (13 to 17 years of age) and adults.
Danish: Forebyggelse efter udsættelse for smitte: Den anbefalede dosis til forebyggelse af influenza efter tæt kontakt med en smittet person er 75 mg oseltamivir en gang daglig i 10 dage for unge (13-17 år) og voksne.
English: • Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties
Danish: • Anafylaktiske og anafylaktoide reaktioner: Alvorlige allergiske reaktioner med hævelse i ansigt og hud, kløende udslæt, lavt blodtryk og vejrtrækningsproblemer
English: - Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community.
Danish: Forebyggelse af influenza - Hos personer, som er 1 år eller ældre, og som har været udsat for smitte fra en person med klinisk diagnosticeret influenza, hvis der er influenza i området.
English: 40 kg or more
Danish: 40 kg eller mere
English: Treatment: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days for adolescents (13 to 17 years of age) and adults.
Danish: Behandling: Den anbefalede orale dosis er 75 mg oseltamivir to gange daglig i 5 dage for unge (13 - 17 år) og voksne.
English: Overdose has been reported to have occurred more frequently when oseltamivir was given to children than to adults and adolescents.
Danish: Overdosering er blevet rapporteret hyppigere, når oseltamivir blev givet til børn sammenlignet med voksne og unge.
English: In most cases of overdose, people have not reported any side effects.
Danish: I de fleste tilfælde blev der ikke rapporteret bivirkninger.
English: The incidence of laboratory-confirmed clinical influenza was 2.9 % (7/238) in the placebo group and 2.1 % (5/237) in the oseltamivir group (95 % CI -2.3 %4.1 %; p = 0.772).
Danish: Forekomsten af laboratoriebekræftet klinisk influenza var 2,9 % (7/238) i placebogruppen og 2,1 % (5/237) i oseltamivirgruppen (95 % konfidensinterval -2,3 % - 4,1 %, p = 0,772).
English: Table 1 Adverse reactions in studies investigating oseltamivir for treatment and prevention of influenza in adults and adolescents or through post-marketing surveillance System Organ Class (SOC)
Danish: Tabel 1 Bivirkninger i studier, som har undersøgt oseltamivir til behandling og forebyggelse af influenza hos voksne og unge eller fra overvågning efter markedsføringen.
English: Required number of Ebilfumin capsules (mg of oseltamivir)
Danish: Antal Ebilfumin-kapsler (mg oseltamivir)
English: If you need a liquid medicine, but it's not available, a suspension can be made up at the pharmacy from Ebilfumin capsules (see Information for healthcare professionals).
Danish: Hvis du har behov for medicinen som væske, og den ikke er tilgængelig, kan en apoteksopblandet suspension tilberedt ud fra Ebilfumin-kapsler anvendes (se information til læger og sundhedspersonale).
English: Extemporaneous formulation
Danish: Magistrel formulering
English: Caution should be exercised when preparing liquid Ebilfumin for children and when administering Ebilfumin capsules or liquid Ebilfumin to children.
Danish: Der skal vises forsigtighed, når Ebilfumin oral suspension tilberedes, og når Ebilfumin kapsler eller oral suspension gives til børn.
English: • One small oral dose dispenser showing measurements of 0.1 ml, to give the dose
Danish: • En lille dispenser til oral dosering, som har inddelinger på 0,1 ml til at give dosis
English: Oseltamivir is effective only against illness caused by influenza viruses.
Danish: Oseltamivir er kun effektivt overfor sygdom forårsaget af influenzavirus.
English: • Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing
Danish: • Angioødem: Pludseligt opstået alvorlig hævelse i huden, især på hoved og hals, herunder øjne og tunge, med vejrtrækningsproblemer
English: However, in one observational study, while the overall malformation risk was not increased, the results for major congenital heart defects diagnosed within 12 months of birth were not conclusive.
Danish: Dog var resultaterne for store medfødte hjertefejl diagnostiseret inden for 12 måneder efter fødslen ikke afgørende i et observationsstudie, hvor den overordnede risiko for misdannelser ikke var øget, men hvor resultatet ikke var endegyldigt.
English: Shellac Glaze-45% (20% esterified) Black iron oxide (E172) Propylene glycol (E1520) Ammonium hydroxide 28% (E527)
Danish: Shellac Glaze-45% (20% estre) Sort jernoxid (E172) Propylenglycol (E1520) Ammoniumhydroxid 28% (E527)
English: Oral dose dispensers (oral syringes) of appropriate volume and grading should be provided for administering the pharmacy compounded suspension, and for the procedures involved in the home preparation.
Danish: Dispensere, til oral dosering (orale sprøjter), af passende størrelse og med passende markeringer bør udleveres til administration af den apoteksopblandede suspension samt til procedurerne involveret i hjemmeopblanding.
English: Adults, and adolescents 13 years and over
Danish: Voksne og unge på 13 år og derover
English: Additionally, diarrhoea and nappy rash have been reported.
Danish: Derudover er diarré og bleudslæt rapporteret.
English: Therefore, dose adjustments are not recommended for pregnant women in the treatment or prophylaxis of influenza (see section 4.6 Fertility, pregnancy and lactation).
Danish: Dosisjustering anbefales derfor ikke hos gravide kvinder ved behandling eller forebyggelse af influenza (se pkt.
English: There is insufficient clinical data available in infants and children (12 years of age and younger) with renal impairment to be able to make any dosing recommendation.
Danish: Der er ikke tilstrækkelige kliniske data tilgængelige vedrørende spædbørn og børn, som er 12 år og yngre, med nedsat nyrefunktion til at kunne give anbefalinger vedrørende dosering.
English: Children 1 year or older, weighing less than 40 kg Child's weight
Danish: Børn på 1 år og derover, som vejer under 40 kg Barnets vægt
English: Renal clearance (18.8 l/h) exceeds glomerular filtration rate (7.5 l/h) indicating that tubular secretion occurs in addition to glomerular filtration.
Danish: Den renale clearance (18,8 l/time) er større end den glomerulære filtration (7,5 l/time).
English: However, for adult immunocompromised patients with renal impairment, doses should be adjusted as outlined in section 4.2.
Danish: Dog skal der hos voksne immunkompromiterende patienter med nedsat nyrefunktion foretages ændringer i dosis i henhold til pkt.
English: 3 mg per kg body weight, twice daily
Danish: 3 mg per kg legemsvægt to gange daglig
English: The appropriate dose must be mixed by the caregiver with an equal quantity of sweet liquid food, such as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce) to mask the bitter taste.
Danish: Omsorgspersonen skal blande den aktuelle dosis op med en tilsvarende mængde af flydende sød mad, såsom sukkervand, chokoladesirup, kirsebærsirup eller dessertsauce (som f.eks. karamelsauce), så den bitre smag maskeres.
English: Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of oseltamivir phosphate (pro-drug) and is extensively converted by predominantly hepatic esterases to the active metabolite (oseltamivir carboxylate).
Danish: Efter oral administration af oseltamivirphosphat (prodrug) absorberes oseltamivir hurtigt fra gastrointestinalkanalen og omdannes i stor udstrækning, overvejende af hepatiske esteraser, til den aktive metabolit (oseltamivircarboxylat).
English: Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant drug interactions via these mechanisms are unlikely.
Danish: Oseltamivirs farmakokinetiske egenskaber, såsom lav proteinbinding og metabolisme, som er uafhængige af CYP450 og glucuronidasesystemer (se pkt.
English: dose for 5 days
Danish: Doseres i 5 dage
English: Dosing chart for pharmacy compounded 6 mg/ml suspension prepared from Ebilfumin capsules for infants less than 1 year of age Body Weight (rounded to the nearest 0.5 kg)
Danish: Doseringsskema for apoteksopblandet 6 mg/ml suspension tilberedt ud fra Ebilfumin-kapsler til spædbørn under 1 år Legemsvægt (afrundet til nærmeste 0,5 kg)
English: • Sweet food to hide the bitter taste of the Ebilfumin.
Danish: • Søde fødevarer til at maskere den bitre smag af Ebilfumin.