FrancophonIA/ELRC3.0 huggingface dataset:
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 Tamiflu is right for you.
Danish: Du skal fortælle lægen, hvis du er gravid, tror du er gravid eller prøver på at blive gravid, så lægen kan beslutte, om Tamiflu er det rigtige til dig.
English: Sorbitol can have a mild laxative effect.
Danish: Sorbitol kan have en mild laksativ effekt.
English: These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
Danish: Disse hændelser kan forekomme i forbindelse med encefalitis eller encefalopati, men kan også forekomme uden åbenlys alvorlig sygdom.
English: Half-lives observed in older people were similar to those seen in young adults.
Danish: De observerede halveringstider hos ældre svarede til dem som er set hos unge voksne.
English: Patients who are unable to swallow capsules:
Danish: Patienter, som ikke kan sluge kapsler:
English: The MAH shall agree the communication plan for the DHPC letter with the National Competent Authority in the Member States where the letter will be distributed.
Danish: Indehaveren af markedsføringstilladelsen skal aftale en kommunikationsplan for DHPC-brevet med de nationale myndigheder i den medlemsstat, hvor brevet skal distribueres.
English: You now have a bottle of Tamiflu oral suspension ready to measure out a dose.
Danish: Du har nu en flaske med Tamiflu oral suspension, som er klar til afmåling af en dosis.
English: • Convulsions and delirium, including altered level of consciousness
Danish: • kramper og febervildelse inklusive ændret bevidsthedsniveau
English: Home preparation
Danish: Fremstilling hjemme
English: METHOD OF ADMINISTRATION For oral use after reconstitution Shake bottle well before use
Danish: ADMINISTRATIONSMETODE Til oral anvendelse efter rekonstituering Ryst flasken godt før brug
English: You will need to do this every time you need a dose.
Danish: Du skal gøre dette hver gang du skal udtage en dosis.
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'et og den aktive metabolit hurtigere end voksne, resulterende i en lavere eksponering for en given mg/kg-dosis.
English: For home preparation, separate dispensers should be provided for taking the correct volume of water and for measuring the Tamiflu-water mixture.
Danish: Til fremstilling hjemme bør der sørges for forskellige dispensere til henholdsvis at udtage det korrekte volumen vand og at afmåle Tamiflu-vand-blandingen.
English: • Two small bowls
Danish: • To små skåle
English: Pack-size of one bottle.
Danish: Pakningsstørrelse 1 flaske
English: If you forget to take Tamiflu Do not take a double dose to make up for a forgotten dose.
Danish: Hvis du har glemt at tage Tamiflu Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Always use the oral dispenser that is provided in the box and has markings indicating the dose in millilitres (ml).
Danish: Brug altid den orale dispenser, som er vedlagt i pakningen og som har markeringer, der indikerer dosis i millilitre (ml).
English: The lower predicted exposure however, remains above inhibitoy 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: 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 mængden af blanding, som du skal trække op.
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 % influenzapositive.
English: This medicine contains sorbitol, which is a form of fructose.
Danish: Denne medicin indeholder sorbitol, som er en form for fructose.
English: - The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection.
Danish: - Den korrekte anvendelse af Tamiflu til forebyggelse af influenza skal afgøres fra patient til patient på grundlag af omstændighederne og den population, som har brug for beskyttelse.
English: Incidence of Oseltamivir Resistance in Clinical Studies
Danish: Forekomst af oseltamivir resistens i kliniske studier
English: Rare but serious effects: get medical help at once (These may affect up to 1 in 1,000 people) During Tamiflu treatment, rare events have been reported that include
Danish: Sjældne, men alvorlige bivirkninger: Søg lægehjælp omgående (Disse kan påvirke op til 1 ud af 1.000 behandlede) Sjældne bivirkninger, som har været rapporteret under behandling med Tamiflu, inkluderer
English: Stop taking Tamiflu and contact a doctor or pharmacist immediately.
Danish: Stop med at tage Tamiflu og kontakt straks lægen eller apoteket.
English: PHARMACEUTICAL FORM AND CONTENTS 1 bottle
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 1 flaske
English: PHARMACEUTICAL FORM AND CONTENTS 10 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 10 hårde kapsler
English: Turn the whole unit upright.
Danish: Vend det hele til opret stilling.
English: Marketing Authorisation Holder and Manufacturer Roche Registration GmbH
Danish: Indehaver af markedsføringstilladelsen og fremstiller Roche Registration GmbH
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 standarddosis-gruppen og 2/2 patienter i dobbeltdosis-gruppen).
English: Shown on the oral dispenser are millilitre (ml) markings of the medicine (see figures in Instructions for the user).
Danish: Der er afsat markeringer på dispenseren for antal millitre (ml) af lægemidlet (se figurer i ”Instruktion til brugeren”).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for bottle
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket til flaske
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 ved steady state var 25 % til 35 % højere hos ældre (fra 65 til 78 år) sammenlignet med voksne under 65 år, som fik tilsvarende doser oseltamivir.
English: See the instructions overleaf to make up and give a dose.
Danish: Se vejledning til at afmåle og give dosis.
English: Fill it with water to the indicated level.
Danish: Opfyld det med vand til afmærkningen.
English: • A bottle of prepared Tamiflu oral suspension
Danish: • En flaske med tilberedt Tamiflu oral suspension
English: Read the package leaflet before use For oral use after reconstitution Shake bottle well before use Caution: dispenser graduated in millilitre (ml)
Danish: Læs indlægssedlen inden brug Til oral anvendelse efter rekonstituering Ryst flasken godt før brug Advarsel: Dispenser er inddelt i milliliter (ml)
English: Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a teaspoon of sugar.
Danish: Eller du kan tilberede sukkervand: Bland en teskefuld vand med trekvart (3/4) teskefuld sukker).
English: Reversible irritancy of rabbits' eyes was detected.
Danish: Der blev set reversibel øjenirritation hos kaniner.
English: Before you take Tamiflu, make sure your prescribing doctor knows if you have hereditary fructose intolerance.
Danish: Før du tager Tamiflu, skal du sikre dig, at den receptudstedende læge kender til det, hvis du lider af arvelig fructose intolerance.
English: Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading.
Danish: Tamiflu er ikke en vaccine, men behandler infektion eller forhindrer influenzavirus i at sprede sig.
English: • Mild to severe liver function disorders
Danish: • Lette til alvorlige forstyrrelser i leverfunktionen
English: The primary efficacy parameter for this study was the incidence of laboratory-confirmed clinical influenza in the households.
Danish: Den primære effektparameter for dette studie var forekomst af laboratorie-bekræftet klinisk influenza i husstandene.
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 karcinogenicitetsstudier hos gnavere viste en tendens til en dosisafhængig øgning i udbredelsen af nogle tumorer, som er typiske for den gnaverrace, der blev anvendt.
English: Based on preclinical data, there is no evidence that Tamiflu has an effect on male or female fertility (see section 5.3).
Danish: Baseret på prækliniske data er der intet som tyder på, at Tamiflu påvirker fertiliteten hos mænd eller kvinder (se pkt.
English: Reports of overdoses with Tamiflu have been received from clinical trials and during post-marketing experience.
Danish: Indberetninger om overdosering af Tamiflu er modtaget fra kliniske studier og efter markedsføring.
English: 0 - 12 months
Danish: 0-12 måneder
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 tilgængelig om børn, der er ammet af mødre, der tager oseltamivir, og om udskillelse af oseltamivir i modermælk.
English: Add all 55 ml of water into the bottle, recap the bottle and shake the closed bottle well for 15 seconds.
Danish: Hæld de 55 ml vand i flasken, luk flasken igen og ryst den godt i 15 sekunder.
English: Final volume of the bottle after reconstitution is 65 ml.
Danish: Det endelige volumen af suspensionen, efter rekonstituering er 65 ml.
English: Patient Population
Danish: Patientpopulation
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 af Tamiflu 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: Peak plasma concentrations of oseltamivir carboxylate decline with a half-life of 6 to 10 hours in most subjects.
Danish: Peak-plasmakoncentrationerne af oseltamivircarboxylat falder med en halveringstid på 6 til 10 timer hos de fleste forsøgspersoner.
English: Shake the suspension well and draw the appropriate recommended dose into the dispenser.
Danish: Ryst suspensionen godt og træk den anbefalede dosis op i dispenseren.
English: The rate of clearance of the active metabolite, corrected for body-weight, decreases with ages below one year.
Danish: Clearancehastigheden af den aktive metabolit, korrigeret for legemsvægt, nedsættes ved alder under 1 år.
English: To make a smaller single dose, you need:
Danish: For at tilberede en mindre enkelt dosis, skal du bruge:
English: Measure 55 ml of water by filling the measuring cup to the indicated level (measuring cup included in the box).
Danish: Afmål 55 ml vand ved at fylde målebægeret op til det afmærkede niveau (målebægeret er vedlagt i pakningen).
English: Before you take Tamiflu, make sure the prescribing doctor knows
Danish: Før du tager Tamiflu, skal du sikre dig, at den receptudstedende læge ved
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 tage hensyn 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: Remove the dispenser from the bottle.
Danish: Fjern dispenseren fra flasken.
English: Tamiflu 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: Tamiflu bør derfor kun anvendes til behandling og forebyggelse af influenza, når pålidelige epidemiologiske data indikerer, at der er influenza i området.
English: There was no resistance observed during a 12-week prophylaxis study in immunocompromised patients.
Danish: Der blev ikke observeret resistens under et 12 ugers profylaksestudie hos immunkompromitterede patienter.
English: Adults, adolescents or children (> 40 kg) who are able to swallow capsules may receive appropriate doses of Tamiflu capsules.
Danish: Voksne, unge eller børn (> 40 kg), som kan sluge kapsler, kan tage en tilsvarende dosis som Tamiflukapsler.
English: Tap the closed bottle gently several times to loosen the powder.
Danish: Bank let på den lukkede flaske flere gange for at løsne pulveret.
English: The safety profile of Tamiflu observed in this study was consistent with that observed in previous clinical trials where Tamiflu was administered for treatment of influenza in non-immunocompromised patients (otherwise healthy patients or “at risk” patients [i.e., those with respiratory and/or cardiac comorbidities]).
Danish: Sikkerhedsprofilen for Tamiflu, der blev observeret i dette studie, var i overensstemmelse med det, der blev observeret i tidligere kliniske studier, hvor Tamiflu 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: 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) indkluderer den sidste kolonne spild ved afmåling.
English: You must use the amount of Tamiflu prescribed by the doctor.
Danish: Du skal anvende denmængde Tamiflu, som lægen har ordineret.
English: Preparation of oral suspension
Danish: Rekonstituering af oral suspension
English: Use of Tamiflu must not affect the evaluation of individuals for annual influenza vaccination.
Danish: Anvendelse af Tamiflu må ikke påvirke vurderingen af den årlige vaccination imod influenza hos den enkelte patient.
English: • Visual disturbances.
Danish: • Synsforstyrrelser.
English: Open a second capsule for a 60 mg dose.
Danish: Åbn endnu en kapsel for at opnå en 60 mg dosis.
English: For details on how to prepare the oral suspension and how to measure and take the medicine, read Instructions for the user, over the page.
Danish: Med hensyn til detaljerede oplysninger om hvorledes den orale suspension tilberedes, hvordan den udmåles og hvordan medicinen indtages, se ”Instruktion til brugeren “nedenfor.
English: • Shake the bottle
Danish: • Ryst flasken
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read package leaflet before use Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Læs indlægssedlen inden brug Oral anvendelse
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 Tamiflu 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 Tamiflu og dets godkendte indikationer.
English: • Conditions or Restrictions with Regard to the Safe and Effective Use of the Medicinal Product
Danish: .• Betingelser eller begrænsninger med hensyn til sikker og effektiv anvendelse af lægemidlet
English: Put the cap back on the bottle.
Danish: Sæt låget tilbage på flasken.
English: The appropriate dispenser sizes for taking the correct volume of Tamiflu suspension (6 mg/ml) are shown below.
Danish: Den passende størrelse på dispenser for at udtage den korrekte volumen af Tamiflu-suspension (6 mg/ml) er vist forneden.
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
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: Open the stated amount of Tamiflu capsules and transfer the content of each capsule directly to the preserved water in the glass beaker.
Danish: Åbn det angivne antal Tamiflu-kapsler og tøm indholdet af hver kapsel direkte i det konserverede vand i glasbægeret.
English: Tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors.
Danish: Tamiflu indeholder oseltamivir, som tilhører en gruppe lægemidler, som kaldes ”neuraminidasehæmmere”.
English: In the majority of patients, these ARs did not lead to discontinuation of Tamiflu.
Danish: Hos størstedelen af patienterne førte disse bivirkninger ikke til ophør af behandling med Tamiflu.
English: • Ear inflammation and other ear disorders
Danish: • Ørebetændelse og andre ørelidelser
English: Date of last renewal: 22 May 2012
Danish: Dato for første markedsføringstilladelse: 28. november 2011 Dato for seneste fornyelse: 22. maj 2012
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 patienter 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 patienter og patienter med kronisk hjerte-eller luftvejssygdom).
English: Tamiflu 6 mg/ml powder for oral suspension is available in a bottle containing 13 g powder for mixing with 55 ml of water.
Danish: Tamiflu 6 mg/ml pulver til oral suspension fås i en flaske, som indeholder 13 g pulver til fremstilling med 55 ml vand.
English: • Use the jug to measure 55 ml of water The measuring jug in the pack has a line marked to show you an exact amount.
Danish: • Brug målebægeret til at afmåle 55 ml vand Målebægeret i pakningen har en afmærkning for at vise den korrekte volumen.
English: • if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu listed in section 6.
Danish: • hvis du er allergisk over for oseltamivir eller et af de øvrige indholdsstoffer angivet i punkt 6.
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 et posteksponeringsforebyggelsesstudie 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: Sodium dihydrogen citrate (E331[a])
Danish: Natriumdihydrogencitrat (E331[a])
English: Tamiflu is not a flu vaccine
Danish: Tamiflu er ikke en influenzavaccine
English: • The active substance is oseltamivir (6 mg/ml oseltamivir after reconstitution).
Danish: • Det aktive stof er oseltamivir (6 mg/ml oseltamivir efter rekonstituering)
English: Neuropsychiatric events have been reported during administration of Tamiflu in patients with influenza, especially in children and adolescents.
Danish: Der er rapporteret om neuropsykiatriske hændelser under administration af Tamiflu hos patienter med influenza, især hos børn og unge.
English: Table 1 Adverse reactions in studies investigating Tamiflu for treatment and prevention of influenza in adults and adolescents or through post-marketing surveillance
Danish: Tabel 1 Bivirkninger i studier, som har undersøgt Tamiflu til behandling og forebyggelse af influenza hos voksne og unge eller fra overvågning efter markedsføringen.
English: • Thrombocytopenia (low platelet count)
Danish: • Trombocytopeni (lavt antal blodplader)
English: During treatment with Tamiflu, tell a doctor immediately:
Danish: Under behandling med Tamiflu skal du omgående fortælle lægen
English: Angioneurotic oedema, Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis
Danish: Angioneurotisk ødem, erythema multiforme, Stevens-Johnsons syndrom, toksisk epidermal nekrolyse
English: Information for the user
Danish: Information til brugeren
English: Tamiflu has no influence on the ability to drive and use machines.
Danish: Tamiflu har ingen kendt påvirkning af evnen til at føre motorkøretøj og betjene maskiner.
English: Instructions for the user
Danish: Instruktion til brugeren
English: When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation of Tamiflu 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 tilberedningn af Tamiflu-suspension yderligere trin.
English: Tamiflu will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor.
Danish: Tamiflu påvirker ikke effekten af en influenzavaccine og lægen kan ordinere begge til dig.
English: Other medicines and Tamiflu Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any.
Danish: Brug af anden medicin sammen med Tamiflu Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin, herunder håndkøbsmedicin, eller har gjort det for nylig.
English: Check the cap is secure, and then shake the bottle of Tamiflu oral suspension.
Danish: Undersøg om låget er fastgjort og ryst derefter flasken med Tamiflu oral suspension.
English: • Tamiflu is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza).
Danish: • Tamiflu anvendes til voksne, unge, børn og spædbørn (herunder fuldbårne nyfødte) til at behandle influenza.
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-dayold 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 død, hos juvenile 7 dage gamle rotteunger.
English: Give the whole contents of the second bowl (Tamiflu liquid mixture with sweet food added) to the child straight away.
Danish: Giv straks barnet hele indholdet af den anden skål (flydende Tamiflu med den søde fødevare).
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 ml eller 10 ml anvendes.