FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse events reported following overdose were similar in nature and distribution to those observed with therapeutic doses of Tamiflu, 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 Tamiflu, som beskrevet i pkt.
English: Overdose has been reported to have occurred more frequently when Tamiflu was given to children than to adults and adolescents.
Danish: Overdosering er blevet rapporteret hyppigere, når Tamiflu blev givet til børn sammenlignet med voksne og unge.
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 rotter med en dosis op til 1.500 mg/kg/dag blev der, uanset køn, ikke påvist bivirkninger.
English: See the second set of instructions.
Danish: Se den anden del af vejledningen.
English: See the first set of instructions.
Danish: Se første del af vejledningen.
English: The suspension is caused by some of the excipients of Tamiflu capsules, which are insoluble.)
Danish: At der dannes suspension skyldes, at nogle af hjælpestofferne i Tamiflu-kapslerne, er uopløselige.)
English: Insufficient data are available for infants who have a post-conceptual age of less than 36 weeks.
Danish: Der er utilstrækkelige data tilgængelige for spædbørn med fosteralder under 36 uger.
English: Adults and adolescents 13 years of age and older: Patients were eligible if they reported within 36 hours of onset of symptoms, had fever ≥ 37.8 °C, accompanied by at least one respiratory symptom (cough, nasal symptoms or sore throat) and at least one systemic symptom (myalgia, chills/sweats, malaise, fatigue or headache).
Danish: Voksne og unge på 13 år og ældre: Patienterne kunne indgå, hvis de meldte sig senest 36 timer efter symptomerne var begyndt, havde feber ≥ 37,8 °C, ledsaget af mindst et respiratorisk symptom (hoste, nasale symptomer eller ondt i halsen) og mindst et systemisk symptom (myalgi, kulderystelser/sveden, utilpashed, træthed eller hovedpine).
English: In patients with influenza who were receiving Tamiflu, 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 Tamiflu, er der efter markedsføring rapporteret om kramper og delirium (inklusive symptomer såsom ændret bevidsthedsniveau, forvirring, abnorm adfærd, vrangforestillinger, hallucinationer, agitation, angst, mareridt).
English: What Tamiflu contains
Danish: Tamiflu indeholder
English: Caution should be exercised when preparing Tamiflu oral suspension and when administering Tamiflu products to children.
Danish: Forsigtighed bør udvises, når Tamiflu oral suspension tilberedes, samt når Tamiflu lægemiddelformer gives til børn.
English: The box also contains 1 plastic measuring jug (55 ml), 1 plastic bottle adapter (to help get the drug into the dispenser),1 plastic 3 ml oral dispenser and 1 plastic 10 ml oral dispenser (to give the correct amount of medicine via the mouth).
Danish: Pakningen indeholder også 1 målebæger (55 ml), 1 flaskeadapter (til at hjælpe til med at få lægemidlet op i dispenseren) og 1 oral dispenser på 3 ml og 1 oral dispenser på 10 ml (for at kunne indtage den korrekte volumen lægemiddel i munden).
English: For adolescents (13 to 17 years of age) and adults: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days.
Danish: Til unge (13 - 17 år) og voksne: Den anbefalede orale dosis er 75 mg oseltamivir to gange daglig i 5 dage.
English: If you stop taking Tamiflu
Danish: Hvis du holder op med at tage Tamiflu
English: People who find it hard to take capsules can use a liquid medicine, Tamiflu oral suspension.
Danish: Mennesker, som har svært ved at sluge kapsler, kan anvende medicinen i flydende form, Tamiflu oral suspension.
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: 1519) i hele populationen (ITT), uanset infektionsstatus hos kontaktpersonerne.
English: Push the plunger completely down toward the tip of the dispenser.
Danish: Pres stemplet helt ned til spidsen af dispenseren.
English: On the basis of drug exposure and tolerability, dosage adjustments are not required for older people unless there is evidence of moderate or severe renal impairment (creatinine clearance below 60 ml /min) (see section 4.2).
Danish: På baggrund af eksponeringen og tolerabiliteten af præparatet er justering af dosis ikke nødvendig hos ældre patienter med mindre der er tegn på moderat eller svært nedsat nyrefunktion (creatininclearance under 60 ml/min.)
English: • Tamiflu may be prescribed for adults, adolescents, children and infant (including full-term newborn babies) as preventive treatment in exceptional circumstances - for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection.
Danish: • Tamiflu kan også ordineres til voksne, unge, børn og spædbørn (herunder fuldbårne nyfødte) som forebyggende behandling i usædvanlige situationer, f.eks. under en influenza-pandemi (global epidemi af influenza), hvis den sæsonbestemte influenzavaccine ikke yder tilstrækkelig beskyttelse.
English: Stage 2 Measure and give the correct dose
Danish: Afmål og giv den korrekte dosis
English: • Sweet food to hide the bitter taste of the Tamiflu.
Danish: • Søde fødevarer til at maskere den bitre smag af Tamiflu.
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 administrering af den apoteksopblandede suspension såvel som til procedurerne involveret i fremstilling hjemme.
English: For people who find it hard to take capsules, including very young children, there's a liquid medicine, Tamiflu oral suspension.
Danish: Mennesker, som har svært ved at sluge kapsler, herunder små børn, kan anvende medicinen i flydende form, Tamiflu oral suspension.
English: Treating flu: dose for 5 days
Danish: Behandling af influenza: Doseres i 5 dage
English: Roche Pharma AG Emil-Barell-Str. 1, D-79639 Grenzach-Wyhlen Germany
Danish: Roche Pharma AG Emil-Barell-Str. 1, D-79639 Grenzach-Wyhlen Tyskland
English: For infants and children 1 year of age or older: Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension.
Danish: Til spædbørn og børn, som er 1 år eller ældre: Tamiflu 30 mg og 45 mg kapsler er tilgængelige som et alternativ til den anbefalede dosis Tamiflu 6 mg/ml suspension.
English: This will make sure that the bottle adapter fits in the bottle in the right position.
Danish: Herved sikres det, at flaskeadaptoren sidder rigtigt i flasken.
English: SPECIAL STORAGE CONDITIONS Powder: Do not store above 30°C After reconstitution, store below 25 °C for 10 days
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Pulver: Må ikke opbevares over 30 °C Efter rekonstituering: Opbevares under 25 °C i 10 dage
English: Dosing chart for pharmacy-compounded 6 mg/ml suspension prepared from Tamiflu capsules for infants and children 1 year of age or older
Danish: Doseringsskema for apoteksfremstillet 6 mg/ml suspension tilberedt ud fra Tamiflu-kapsler til spædbørn og børn, som er 1 år eller ældre
English: Giving Tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant.
Danish: Hvorvidt Tamiflu skal gives til spædbørn under 1 år for at forebygge influenza under en influenza epidemi, baseres på lægens vurdering af de mulige fordele for barnet holdt op imod enhver mulig risiko.
English: For dosing, a 3 ml and 10 ml oral dispenser is provided in the box.
Danish: Til afmåling af dosis medfølger en oral dispenser på 3 ml og 10 ml i pakningen.
English: What you need to know before you take Tamiflu Do not take Tamiflu:
Danish: Det skal du vide, før du begynder at tage Tamiflu Tag ikke Tamiflu:
English: For infants less than 1 year of age: The recommended prophylaxis dose for infants less than 12 months during a pandemic influenza outbreak is half of the daily treatment dose.
Danish: Til spædbørn under 1 år: Den anbefalede profylaktiske dosis til spædbørn under 12 måneder under et pandemisk influenzaudbrud, er halvdelen af den daglige behandlingsdosis.
English: • Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis - for instance, if you have been in contact with someone who has flu.
Danish: • Tamiflu kan også i enkelte tilfælde ordineres til voksne, unge, børn og spædbørn over 1 år for at forebygge influenza, f.eks. hvis du har været i kontakt med en person, som har influenza.
English: Post-exposure prevention
Danish: Forebyggelse efter udsættelse for smitte
English: • Upper abdominal fullness
Danish: • Oppustethed i øvre maveregion
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
English: 30 mg (suspension or capsules) every second day
Danish: 30 mg (suspension eller kapsler) hver anden dag
English: To make a 75 mg dose, you need:
Danish: For at tilberede en 75 mg dosis skal du bruge:
English: If the commercially manufactured Tamiflu oral suspension and the pharmacy compounded suspension is also not available, Tamiflu suspension may be prepared at home.
Danish: I tilfælde af at hverken fabriksfremstillet Tamiflu oral suspension eller en apoteksfremstillet suspension er tilgængelig, kan Tamiflu-suspension tilberedes hjemme.
English: The NNT for the total paediatric population was 9 (95 % CI 7 - 24) and 8 (95 % CI 6, upper limit not estimable) in the whole population (ITT) and in paediatric contacts of infected index cases (ITTII), respectively.
Danish: NNT for den samlede pædiatriske population var 9 (95 % konfidensinterval 7-24) og 8 (95 % konfidensinterval 6, øvre grænse kan ikke estimers) i henholdsvis den samlede population (ITT) og i pædiatriske kontakter af inficerede indekstilfælde (ITTII).
English: • Skin reactions (inflammation of the skin, red and itchy rash, scaling skin).
Danish: • Hudreaktioner (betændelse/irritation i huden, rødt og kløende udslæt, hudafskalning).
English: 75 mg can be made up of a 30 mg capsule plus a 45 mg capsule Children 1 to 12 years
Danish: 75 mg kan bestå af en kapsel på 30 mg samt en kapsel på 45 mg Børn 1 til 12 år
English: The following dosing regimen is recommended for infants less than 1 year of age: Dosing table of oseltamivir for children below one year of age : 3 mg/kg once daily Body Weight* Recommended dose for 10 days
Danish: Følgende doser anbefales til spædbørn under 1 år: Doseringstabel for oseltamivir til børn under1 år: 3 mg/kg én gang daglig Legemsvægt* Anbefalet dosis i 10 dage Mængde oral suspension, som skal udtages
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 og indenfor to dage efter kontakt med en smittet person.
English: • Depending on the required dose you will need the 3 ml oral dispenser (yellow plunger, 0.1 ml graduation) or the 10 ml oral dispenser (white plunger 0.5 ml graduation) from the medicine pack.
Danish: • Afhængigt af den påkrævede dosis bruger du en 3 ml oral dispenser (gult stempel, 0,1 ml inddeling) eller 10 ml oral dispenser (hvidt stempel, 0,5 ml inddeling) , som er vedlagt i pakningen
English: • Two small bowls (use separate pairs of bowls for each child)
Danish: (brug et separat sæt skåle til hvert barn)
English: The NNT in this study was 25 (95 % CI 23
Danish: NNT i dette studie var 25 (95 % konfidensinterval:
English: Storage of the pharmacy compounded suspension Shelf life of 10 days when stored below 25 °C.
Danish: Opbevaring af apoteksfremstillet suspension: Holdbarhed 10 dage, når suspensionen opbevares under 25 °C.
English: Infants less than 1 year (including full-term new born babies):
Danish: Spædbørn under 1 år (herunder fuldbårne nyfødte):
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 June 2002
Danish: Dato for første markedsføringstilladelse: 20. juni 2002 Dato for seneste fornyelse: 22. maj 2012
English: Push the tip of the dispenser into the bottle adapter.
Danish: Tryk spidsen af dispenseren ned i flaskeadaptoren.
English: In vitro studies demonstrated that neither oseltamivir nor the active metabolite is a substrate for, or an inhibitor of, the major cytochrome P450 isoforms.
Danish: In vitro-studier har vist at hverken oseltamivir eller den aktive metabolit er substrat for eller hæmmer af CYP-isoformer.
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 en metabolisme, som er uafhængig af CYP450 og glukuronidasesystemer (se pkt.
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: 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 oseltamivirresistent virus, var smittebærere i en længere periode sammenlignet med forsøgspersoner med følsom virus.
English: If you forget to take Tamiflu
Danish: Hvis du har glemt at tage Tamiflu
English: Infants less than 1 year, and children weighing less than 40 kg
Danish: Spædbørn under 1 år og børn som vejer mindre end 40 kg.
English: - Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age during a pandemic influenza outbreak (see section 5.2).
Danish: - Hos spædbørn under 1 år, er Tamiflu indiceret til forebyggelse af influenza efter eksponering under et pandemisk influenzaudbrud (se pkt.
English: When commercially manufactured Tamiflu oral suspension is not available, a pharmacy compounded suspension prepared from Tamiflu capsules must be used (see detailed instructions above).
Danish: I tilfælde af at fabriksfremstillet Tamiflu oral suspension ikke er tilgængelig, bør en apoteksfremstillet suspension tilberedt ud fra Tamiflu-kapsler anvendes (detaljerede instruktioner findes ovenfor).
English: The MAH shall ensure that at the launch of Tamiflu 6 mg/ml powder for oral suspension, all physicians who are expected to prescribe or use Tamiflu are provided with a Direct Healthcare Professional Communication letter, the text of which is appended to the CHMP assessment report.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at ved lanceringen af Tamiflu 6 mg/ml pulver til oral suspension, leveres et Direct Healthcare Professional Communication (DHPC)-brev til alle læger som forventes at ordinere eller anvende Tamiflu.
English: This is based upon pharmacokinetic and safety data indicating that this dose in infants 0 - 12 months provides plasma concentrations of the pro-drug and active metabolite that are anticipated to be clinically efficacious with a safety profile comparable to that seen in older children and adults (see section 5.2).
Danish: Dette er baseret på farmakokinetiske data og sikkerhedsdata, som indikerer, at denne dosis hos 0-12 måneder gamle spædbørn giver en plasmakoncentration af prodrug og aktiv metabolit, som forventes at være klinisk effektiv og med en sikkerhedsprofil, som er sammenlignelig med den, som ses hos ældre børn og voksne (se pkt.
English: Volume of pharmacy compounded 6 mg/ml suspension prepared based upon the patient's weight
Danish: Volumen af apoteksfremstillet 6 mg/ml suspension, som skal tilberedes, baseret på patientens vægt Legemsvægt (kg)
English: You should use only 45 mg capsules for 45 mg doses.
Danish: Du skal kun bruge 45 mg kapsler til 45mg dosis.
English: • Conjunctivitis (red eyes and discharge or pain in the eye)
Danish: • Øjenbetændelse (røde øjne og pus eller smerter i øjet)
English: It can be used when you have flu symptoms, and the flu virus is known to be going round in your community.
Danish: Tamiflu kan anvendes, hvis du har influenza-symptomer, og det er kendt, at influenzavirus er spredt i lokalbefolkningen.
English: Dispenser size to use
Danish: Størrelse på dispenser, som skal anvendes
English: This is suitable for younger children and babies: they usually need a Tamiflu dose of less than 30 mg. See the lower set of instructions.
Danish: Dette er hensigtsmæssigt til yngre børn og spædbørn; de har oftest behov for Tamiflu doser, som er mindre end 30 mg. Se den nederste del af vejledningen.
English: For adolescents (13 to 17 years of age) and adults: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days.
Danish: Til unge (13 - 17 år) og voksne: Den anbefalede dosis til forebyggelse af influenza efter tæt kontakt med smittede personer er 75 mg oseltamivir en gang daglig i 10 dage.
English: Children weighing > 40 kg and who are able to swallow capsules may receive treatment with the adult dosage of 75 mg capsules twice daily for 5 days as an alternative to the recommended dose of Tamiflu suspension.
Danish: Børn, som vejer mere end 40 kg, og som kan sluge kapsler, kan behandles med en voksendosis på 75 mg to gange daglig i 5 dage som et alternativ til den anbefalede dosis Tamiflu-suspension.
English: Take this medicine exactly as your doctor has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens anvisning.
English: There is no evidence for efficacy of oseltamivir in any illness caused by agents other than influenza viruses (see section 5.1).
Danish: Der er ikke bevis på effekt af oseltamivir ved sygdomme forårsaget af andet end influenzavirus (se pkt.
English: It is recommended that Tamiflu powder for oral suspension be constituted by a pharmacist prior to dispensing to the patient (see section 6.6).
Danish: Der anbefales at Tamiflu-pulver til oral suspension rekonstitueres af apoteket, før den udleveres til patienten (se pkt.
English: Xanthan gum (E415)
Danish: Xanthangummi (E415)
English: Dispenser size to use (grading 0.1 ml)
Danish: Størrelse på dispenser, som skal anvendes (0,1 ml inddelinger)
English: Paediatric population (infants less than one year of age) 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: • The other ingredients are sorbitol (E420), sodium dihydrogen citrate (E331[a]), xanthan gum (E415), sodium benzoate (E211), saccharin sodium (E954), titanium dioxide (E171) and 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: • Øvrige indholdsstoffer er sorbitol (E420), natriumdihydrogencitrat (E331[a]), xanthangummi (E415), natriumbenzoat (E211), saccharinnatrium (E954), titandioxid (E171) og tutti frutti smagsstof (indeholdende maltodextrins [majs], propylenglykol, gummi arabicum E414 og naturlige smagsstoffer (hovedsageligt bestående af banan-, ananas- og ferskensmag).
English: In case of a pandemic, a 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing children below 1 year of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension.
Danish: I tilfælde af en pandemi bør en 3 ml oral dispenser (inddelt i trin på 0,1 ml) anvendes til dosering hos børn under 1 år og som behøver 1 ml til 3 ml af Tamiflu 6 mg/ml oral suspension.
English: After reconstitution, store below 25 °C for 10 days.
Danish: Efter rekonstituering: Opbevares under 25 °C i 10 dage
English: This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual age less than 36 weeks.
Danish: Denne dosisanbefaling er ikke beregnet til for tidligt fødte spædbørn, hvilket vil sige spædbørn med en fosteralder under 36 uger.
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 (1317 år) og voksne.
English: After reconstitution with 55 ml of water, the usable volume of oral suspension allows for the retrieval of a total of 10 doses of 30 mg oseltamivir.
Danish: Efter rekonstituering med 55 ml vand kan der udtages i alt 10 doser a 30 mg oseltamivir fra den brugsfærdige orale suspension.
English: For higher doses the 10 ml syringe should be used.
Danish: 10 ml sprøjter skal anvendes til højere doser.
English: The use of Tamiflu 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 Tamiflu 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: For infants less than 1 year of age: The recommended treatment dose for infants 0 - 12 months of age is 3 mg/kg twice daily.
Danish: Til spædbørn under 1 år: Den anbefalede behandlingsdosis til 0-12 måneder gamle spædbørn , er 3 mg/kg to gange daglig.
English: Safety information available on oseltamivir administered for treatment of influenza in infants less than one year of age from prospective and retrospective observational studies (comprising together more than 2,400 infants of that age class), epidemiological databases research and postmarketing reports suggest that the safety profile in infants less than one year of age is similar to the established safety profile of children aged one year and older.
Danish: Sikkerhedsinformation vedrørende oseltamivir administreret til behandling af influenza hos spædbørn under 1 år er tilgængelig fra pro- og retrospektive observationsstudier (bestående af tilsammen mere end 2.400 spædbørn i denne aldersklasse), epidemiologisk databaseforskning og postmarketing rapporter.