FrancophonIA/ELRC3.0 huggingface dataset:
English: There has been no evidence for emergence of drug resistance associated with the use of Tamiflu in clinical studies conducted to date in post-exposure (7 days), post-exposure within household groups (10 days) and seasonal (42 days) prevention of influenza in immunocompetent patients.
Danish: I kliniske studier har der til dags dato ikke været evidens for udvikling af lægemiddelresistens i forbindelse med anvendelsen af Tamiflu ved post-eksponering (7 dage), post-eksponering inden for husstanden (10 dage) og sæsonbestemt (42 dage) forebyggelse af influenza hos immunkompetente patienter.
English: once daily mg per kg = mg for each kilogram of the infant's body weight.
Danish: 3 mg per kg legemsvægt én gang daglig mg per kg = mg for hvert kilogram af barnets vægt.
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: Tamiflu powder for suspension will appear as an opaque and white to light yellow suspension after reconstitution.
Danish: Tamiflu-pulver til oral suspension fremstår efter rekonstituering som en uigennemsigtig hvid til lysegul suspension.
English: No dose adjustment is required when co-administering with probenecid in patients with normal renal function.
Danish: Dosisjustering er ikke nødvendig, når oseltamivir gives sammen med probenecid til patienter med normal nyrefunktion.
English: • Upper respiratory tract infections (inflammation of the nose, throat and sinuses)
Danish: • Infektioner i øvre luftveje (betændelse i næse, hals og bihuler)
English: Slowly pull out the plunger to draw medicine into the dispenser.
Danish: Træk langsomt stemplet ud for at trække medicinen i dispenseren.
English: It is recommended that Tamiflu oral suspension should be reconstituted by the pharmacist prior to being dispensed to the patient.
Danish: Det anbefales, at Tamiflu oral suspension rekonstitueres af apoteket, før den udleveres til patienten.
English: The safety profile reported in subjects who received the recommended dose of Tamiflu for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.
Danish: Sikkerhedsprofilen, som blev rapporteret hos forsøgspersoner, der fik den anbefalede dosis af Tamiflu til forebyggelse (75 mg én gang daglig i op til 6 uger), var kvalitativt svarende til den, som er set i behandlingsstudierne, på trods af en længere doseringsvarighed i forebyggelsesstudierne.
English: Tamiflu is not a substitute for influenza vaccination.
Danish: Tamiflu er ikke en erstatning for influenzavaccination.
English: In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to 12 years of age and older, the safety profile in the 238 patients who received oseltamivir was consistent with that previously observed in Tamiflu prophylaxis clinical studies.
Danish: I et 12-ugers forebyggelsesstudie med 475 immunkompromitterede patienter, herunder 18 børn i alderen 1 til 12 år og derover, var sikkerhedsprofilen for de 238 patienter, som fik oseltamivir, i overensstemmelse med den, som tidligere er observeret i kliniske forebyggelsesstudier med Tamiflu.
English: Do not take Tamiflu.
Danish: Tag ikke Tamiflu.
English: Store the medicine below 25 º C for up to 10 days.
Danish: Opbevar medicinen under 25⁰C op til 10 dage.
English: Amount of Tamiflu suspension
Danish: Volumen af Tamiflususpension
English: One bottle of reconstituted suspension (65 ml) contains 390 mg of oseltamivir.
Danish: En flaske med rekonstitueret suspension (65 ml) indeholder 390 mg af oseltamivir.
English: Table 2 Adverse reactions in studies investigating Tamiflu for treatment and prevention of influenza in children (age/weight-based dosing [30 mg to 75 mg o.d.])
Danish: Tabel 2 Bivirkninger i studier, som undersøger Tamiflu til behandling og forebyggelse af influenza hos børn (alder/vægt baseret dosering [30 mg til 75 mg en gang dagligt]).
English: • The bottle, containing Tamiflu powder (in the medicine pack)
Danish: • Flasken som indeholder Tamiflu-pulver (i pakningen)
English: Post-exposure prevention: The recommended post-exposure prevention dose of Tamiflu is:
Danish: Forebyggelse efter udsættelse for smitte: De anbefalede forebyggende doser af Tamiflu efter udsættelse for smitte er:
English: In addition, 199 immunocompromised adult patients received Tamiflu for the treatment of influenza and 475 immunocompromised patients (including 18 children, of these 10 Tamiflu and 8 placebo) received Tamiflu or placebo for the prophylaxis of influenza.
Danish: Yderligere fik 199 immunkompromitterede voksne patienter Tamiflu til behandling af influenza og 475 immunkompromitterede patienter (inklusive 18 børn, hvoraf 10 fik Tamiflu, og 8 fik placebo) fik Tamiflu eller placebo til forebyggelse af influenza.
English: This procedure describes the preparation of a 6 mg/ml suspension that will provide one patient with enough medicine for a 5-day course of treatment or a 10-day course of prophylaxis.
Danish: Denne procedure beskriver tilberedningn af en 6 mg/ml suspension, som vil forsyne en patient med nok medicin til et 5-dages behandlingsforløb eller et 10-dages profylaktisk forløb.
English: You will need to prepare a dose of less than 75 mg for children who weigh less than 40 kg. See below.
Danish: Ikke til børn som vejer mindre end 40 kg. Du skal tilberede en dosis på mindre end 75 mg til børn som vejer mindre end 40 kg. Se nedenfor.
English: Titanium dioxide (E171) FD and C Blue 2 (indigo carmine, E132)
Danish: Titandioxid (E171) FD og C Blue 2 (indigocarmin, E132)
English: Therefore, prescribers should take into account the most recent information available on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use Tamiflu.
Danish: Ordinerende læger bør derfor tage højde for den senest foreliggende information om de aktuelt cirkulerende viras følsomhedsmønstre over for oseltamivir, i beslutningen om anvendelse af Tamiflu.
English: The overall safety profile of Tamiflu is based on data from 6049 adult/adolescent and 1473 paediatric patients treated with Tamiflu or placebo for influenza, and on data from 3990 adult/adolescent and 253 paediatric patients receiving Tamiflu or placebo/no treatment for the prophylaxis of influenza in clinical trials.
Danish: Den samlede sikkerhedsprofil for Tamiflu er baseret på data fra kliniske studier omfattende 6.049 voksne/unge og 1.473 pædiatriske patienter behandlet med Tamiflu eller placebo for influenza, og på data fra kliniske studier med 3.990 voksne/unge og 253 pædiatriske patienter, som fik Tamiflu eller placebo/ingen behandling til forebyggelse af influenza.
English: For infants and children1 year of age or older: The recommended dose of Tamiflu 6 mg/ml oral suspension is indicated in the table below.
Danish: Til spædbørn og børn, som er 1 år eller ældre: Den anbefalede dosis af Tamiflu 6 mg/ml oral suspension er anvist i tabellen nedenfor.
English: Deliver the suspension directly into the mouth by pushing down the plunger of the dispenser.
Danish: Giv suspensionen direkte i munden ved at trykke stemplet i dispenseren ned.
English: Tutti frutti flavour (including maltodextrins [maize], propylene glycol, arabic gum E414 and natural identical flavouring substances [mainly consisting of banana, pineapple and peach flavour]).
Danish: Tutti frutti smagsstof (indeholdende maltodextriner [majs], propylenglycol, gummi arabicum E414 og naturlige smagsstoffer) [hovedsageligt bestående af banan-, ananas- og ferskensmag]).
English: 100 ml amber glass bottle (with child-resistant polypropylene screw cap, outer part: polyethylene; inner part: polypropylene; liner: polyethylene) with 13 g of powder for oral suspension, a plastic adapter (low density polyethylene) , plastic 3 ml oral dispenser (0.1 ml graduation) and 10 ml oral dispenser (0.5 ml graduation) (barrel and plunger: polypropylene, silicon based seal ring) and a plastic measuring cup (polypropylene).
Danish: 100 ml glasflaske (med børnesikret polypropylenskruelåg, ydre del: polyethylen, indre del: polypropylen, foring: polyethylen) med 13 g pulver til oral suspension, en plastikadaptor (lavdensitet polyethylen), plastik oral dispenser på 3 ml (0,1 ml inddelinger) og 10 ml (0,5 ml inddelinger) (cylinder og stempel : polypropylen, siliconbaseret tætningsring) og et plastikmålebæger (polypropylen).
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 noget af suspensionen tilbage i den anden skål, så skyl skålen med en lille smule vand og lad barnet drikke det hele.
English: Take the dispenser apart straight after dosing, and rinse both parts of the dispenser under running tap water.
Danish: Skil dispenseren ad umiddelbart efter at medicinen er taget og skyl begge dele under rindende vand fra vandhanen.
English: Screw the cap tightly onto the top of the bottle, which now includes the adapter.
Danish: Skru låget godt fast på toppen af flasken, som nu indeholder adaptoren.
English: Volume per dose (6 mg/ml)
Danish: Volumen per dosis (6 mg/ml)
English: No pharmacokinetic interactions between oseltamivir or its major metabolite have been observed when co-administering oseltamivir with paracetamol, acetylsalicylic acid, cimetidine, antacids (magnesium and aluminium hydroxides and calcium carbonates), rimantadine or warfarin (in subjects stable on warfarin and without influenza).
Danish: Der er ikke set farmakokinetiske interaktioner mellem oseltamivir eller dets hovedmetabolit, når oseltamivir gives samtidig med paracetamol, acetylsalicylsyre, cimetidin, antacida (magnesium- og aluminiumhydroxider og calciumcarbonater), rimantadin eller warfarin (mht. warfarin gælder det hos patienter, som er stabile på warfarin og ikke har influenza).
English: Amount of oral suspension to withdraw
Danish: Mængde oral suspension, som skal udtages
English: You must tell your doctor if you are breast-feeding so that your doctor can decide if Tamiflu is right for you.
Danish: Du skal fortælle det til lægen, hvis du ammer, så lægen kan beslutte, om Tamiflu er det rigtige til dig.
English: In pre- and post-natal rat studies, prolonged parturition was noted at 1,500 mg/kg/day: the safety margin between human exposure and the highest no-effect dose (500 mg/kg/day) in rats is 480-fold for oseltamivir and 44-fold for the active metabolite, respectively.
Danish: I præ- og postnatale studier på rotter blev der set forlængelse af fødslen i doser på 1.500 mg/kg/dag: sikkerhedsmarginen mellem human eksponering og den højeste uvirksomme dosis hos rotter (500 mg/kg/dag) er en faktor 480 for oseltamivir og en faktor 44 for den aktive metabolit.
English: In a double blind study for the treatment of influenza, a total of 199 adult immunocompromised patients (evaluable for safety) were randomized to receive Tamiflu for 10 days: 98 patients received the standard dose (75 mg twice daily) and 101 patients received the double dose (150 mg twice daily).
Danish: I et dobbeltblindet studie til behandling af influenza blev i alt 199 voksne immunkompromitterede patienter (evaluerbare for sikkerhed) randomiseret til at få Tamiflu i 10 dage: 98 patienter fik standarddosis (75 mg to gange dagligt) og 101 patienter fik dobbeltdosis (150 mg to gange dagligt).
English: • Fill the dispenser with the correct dose Unscrew the cap from the bottle.
Danish: • Fyld dispenser med den korrekte dosis Skru låget af flasken.
English: Treatment of influenza in high risk populations: The median duration of influenza illness in older subjects (≥ 65 years) and in subjects with chronic cardiac and/or respiratory disease receiving oseltamivir 75 mg twice daily for 5 days was not reduced significantly.
Danish: Behandling af influenza i høj-risiko populationer: Den mediane sygdomsvarighed hos ældre patienter (≥ 65 år) og hos patienter med kroniske hjerte- og/eller åndedrætssygdomme, som fik 75 mg oseltamivir to gange daglig i 5 dage, nedsattes ikke signifikant.
English: Psychiatric disorders and nervous system disorders Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes.
Danish: Influenza kan være forbundet med forskellige neurologiske og adfærdsmæssige symptomer, som kan inkluderehallucinationer, delirium og abnorm adfærd og som i visse tilfælde har været dødelige.
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 nyrefunktionen.
English: • Altered level of consciousness
Danish: • Bevidsthedsændringer
English: Children 1 year or older, weighing less than 40 kg:
Danish: Børn 1 år eller ældre, som vejer mindre end 40 kg:
English: Stage 1: Prepare a new bottle of the medicine
Danish: Tilbered en ny flaske af medicinen
English: A total of 158 children received the recommended dose of Tamiflu once daily in a post-exposure prophylaxis study in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12-week paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10).
Danish: I alt 158 børn fik den anbefalede dosis Tamiflu en gang daglig i et forebyggelsesstudie med husstande, som havde været udsat for smitte (n = 99), i et 6-ugers sæsonbestemt pædiatrisk forebyggelsesstudie (n = 49) og i et 12-ugers sæsonbestemt pædiatrisk forebyggelsesstudie med immunkompromitterede børn (n=10).
English: Preventing flu: dose for 10 days
Danish: Forebyggelse af influenza: Doseres i 10 dage
English: The most frequently (very common and common) reported side effects of Tamiflu are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain.
Danish: De hyppigst (meget almindelige og almindelige) rapporterede bivirkninger af Tamiflu er kvalme og opkastning, mavesmerter, maveproblemer, hovedpine og smerter.
English: Take Tamiflu as soon as possible, ideally within two days of the flu symptoms starting.
Danish: Tag Tamiflu så hurtigt som muligt, helst inden for to dage efter influenzasymptomernes start.
English: Saccharin sodium (E954)
Danish: Saccharinnatrium (E954)
English: • Press in the adapter Open the bottle and press the bottle adapter hard into the neck of the bottle.
Danish: • Sæt adaptoren på Åbn flasken og tryk flaskeadaptoren hårdt på plads i flaskehalsen.
English: Always use the oral dispenser provided with your medicine to measure a correct dose.
Danish: Anvend altid den orale dispenser, som er vedlagt i pakningen, til at måle en korrekt dosis.
English: Such neuropsychiatric events have also been reported in patients with influenza who were not taking Tamiflu.
Danish: Sådanne neuropsykiatriske hændelser er også blevet rapporteret hos patienter med influenza, som ikke fik Tamiflu.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT The volume of the reconstituted suspension is 65 ml 1 ml contains 6 mg oseltamivir
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Den rekonstituerede suspensions volumen er 65 ml 1 ml indeholder 6 mg oseltamivir
English: To make a 30 mg or a 60 mg dose, you need:
Danish: For at tilberede en 30 mg eller 60 mg dosis skal du bruge:
English: The mean volume of distribution at steady state of the oseltamivir carboxylate is approximately 23 litres in humans, a volume equivalent to extracellular body fluid.
Danish: Det gennemsnitlige fordelingsvolumen ved steady state af oseltamivircarboxylat hos mennesker er ca. 23 liter, et volumen som svarer til ekstracellulærvæsken.
English: • Sleeping difficulties
Danish: • Søvnbesvær
English: Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy compounded 6 mg/ml suspension
Danish: Antal kapsler og volumen af vehikel, som er nødvendig for at tilberede det totale volumen af en apoteksfremstillet 6 mg/ml suspension Samlet volumen af opblandet suspension, som skal fremstilles
English: • Tap the bottle to loosen the powder Tap the closed bottle gently several times to loosen the powder.
Danish: • Bank på flasken for at løsne pulveret Bank let på den lukkede flaske flere gange for at løsne pulveret.
English: Since neuraminidase activity is extracellular, oseltamivir carboxylate distributes to all sites of influenza virus spread.
Danish: Eftersom neuraminidaseaktiviteten er ekstracellulær fordeles oseltamivircarboxylat til alle steder med influenza virusspredning
English: This is to hide the bitter taste of the Tamiflu.
Danish: Dette vil maskere den bitre smag af Tamiflu.
English: Infants less than 1 year (including full-term newborn babies) Child's weight (nearest)
Danish: Spædbørn under 1 år (herunder fuldbårne nyfødte) Barnets vægt (nærmeste)
English: Additionally, diarrhoea and diaper rash have been reported.
Danish: Derudover er diarré og bleudslæt rapporteret.
English: Stir the mixture well.
Danish: Rør blandingen grundigt.
English: Information for healthcare professionals only
Danish: Nedenstående oplysninger er til læger og sundhedspersonale
English: An overall higher incidence of oseltamivir-resistance was observed in adult immunocompromised patients treated with standard dose or double dose of oseltamivir for a duration of 10 days [14.9% (10/67) in standard dose group and 2.8% (2/71) in double dose group], compared to data from studies with oseltamivir-treated otherwise healthy adult patients.
Danish: En overordnet højere forekomst af oseltamivir-resistens blev observeret hos voksne immunkompromitterede patienter behandlet med standarddosis eller dobbeltdosis oseltamivir i en varighed på 10 dage [14,9% (10/67) i standarddosis-gruppen og 2,8% (2/71) i dobbeltdosis-gruppen] sammenlignet med data fra studier med oseltamivirbehandlede ellers raske voksne patienter.
English: Add a small amount - no more than one teaspoonful - of a sweet food to the second bowl.
Danish: Tilføj en lille smule - ikke mere end en teskefuld af den søde fødevare - til den anden skål.
English: Prevention of influenza - 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 af en person med klinisk diagnosticeret influenza, hvis der er influenza i området.
English: Tamiflu 30 mg, 45 mg and 75 mg capsules and oral suspension are available for infants and children 1 year of age or older
Danish: Tamiflu findes som 30 mg, 45 mg og 75 mg kapsler og oral suspension til spædbørn og børn, som er 1 år eller ældre.
English: Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community.
Danish: Tamiflu er indiceret til voksne og børn, herunder fuldbårne nyfødte, med typiske symptomer på influenza, når der er influenza i området.
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 apoteksfremstillet 6 mg/ml suspension, som vist i nedenstående tabel:
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: For opbevaring efter rekonstituering af lægemidlet, se pkt.
English: Patients who are unable to swallow capsules may receive appropriate doses of Tamiflu suspension.
Danish: Patienter, som ikke kan sluge kapsler, kan tage Tamiflu-suspension i en tilsvarende dosis.
English: Infants less than 1 year of age: The pharmacokinetics, pharmacodynamics and safety of Tamiflu 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 Tamiflu er blevet evalueret i to åbne, ukontrollerede studier med influenzasmittede børn under 1 år (n=135).
English: Also contains 1 plastic bottle adapter, 1 plastic measuring cup (55 ml), 1 plastic 3 ml oral dispenser and 1 plastic 10 ml oral dispenser.
Danish: Indeholder også 1 plastik flaskeadaptor, 1 plastik målebæger (55 ml), 1 plastik oral dispenser på 3 ml og 1 plastik oral dispenser på 10 ml
English: Depending on the required dose, use the 3 ml dispenser (yellow plunger) or the 10 ml oral dispenser (white plunger) provided in the pack.
Danish: Afhængig af den påkrævede dosis, brug 3 ml dispenseren (gult stempel) eller 10 ml dispenseren (hvidt stempel) , som er vedlagt i pakningen.
English: Do not use 45 mg capsules
Danish: Brug ikke 45 mg kapsel
English: Powder: Do not store above 30°C.
Danish: Pulver: Må ikke opbevares over 30 °C.
English: The following serious adverse reactions have been rarely reported since oseltamivir has been marketed: Anaphylactic and anaphylactoid reactions, hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice), angioneurotic oedema, Stevens-Johnson syndrome and toxic epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders.
Danish: Følgende alvorlige bivirkninger har været rapporteret sjældent siden markedsføring af oseltamivir: Anafylaktiske og anafylaktoide reaktioner, leversygdomme (fulminant hepatitis, leverfunktionsforstyrrelser og gulsot), angioødem, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse, gastrointestinal blødning samt neuropsykiatriske lidelser (se pkt.
English: Pharmacy compounded 6 mg/ml suspension prepared from capsules
Danish: Apoteksfremstillet 6 mg/ml suspension tilberedt ud fra kapsler
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 i eksponeringen for oseltamivirs aktive metabolit til ca. det dobbelte.
English: Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension.
Danish: Tamiflu 30 mg og 45 mg kapsler er tilgængelige som et alternativ til den anbefalede dosis Tamiflu 6 mg/ml suspension.
English: Use the larger dispenser to draw up 5 ml water.
Danish: Brug den store dispenser for at trække 5 ml vand op.
English: The pharmacist may compound a 6 mg/ml suspension from Tamiflu 30 mg, 45 mg or 75 mg capsules using water containing 0.05 % w/v sodium benzoate added as a preservative.
Danish: Farmaceuten kan opblande en 6 mg/ml suspension ud fra Tamiflu 30 mg, 45 mg eller 75 mg kapsler ved at anvende vand indeholdende 0,05 % w/v natriumbenzoat tilsat som konserveringsmiddel.
English: Method of administration Swallow the capsules whole with water.
Danish: Du skal sluge kapslerne hele med vand.
English: Eczema, Dermatitis, Rash, Urticaria
Danish: Eksem, dermatitis, udslæt, urticaria
English: Detailed instructions can be found in the package leaflet of Tamiflu capsules under “Making liquid Tamiflu at home”.
Danish: Detaljerede instruktioner kan findes i indlægssedlen for Tamiflu-kapsler under ”Fremstilling hjemme af flydende Tamiflu”.
English: Tamiflu contains fructose
Danish: Tamiflu indeholder fructose
English: Mix the sweet food and Tamiflu liquid well.
Danish: Bland den søde fødevare og flydende Tamiflu grundigt.