FrancophonIA/ELRC3.0 huggingface dataset:
English: These events were reported primarily among paediatric patients and often had an abrupt onset and rapid resolution.
Danish: Disse hændelser blev primært indberettet hos pædiatriske patienter, og de havde ofte en pludselig debut og forsvandt hurtigt igen.
English: Peramivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and is also important for viral entry into uninfected cells, which causes further spread of infectious virus in the body.
Danish: Peramivir er en hæmmer af influenzavirus-neuraminidase, der er et enzym, som frigiver virale partikler fra plasmamembranen i inficerede celler, og er også vigtig for virussets indtrængen i ikkeinficerede celler, hvilket er med til at sprede infektiøs virus i kroppen yderligere.
English: Table 4: Key efficacy results from study 0722T0621 (ITTI Population) Peramivir 600 mg n=97
Danish: Tabel 4: Væsentligste effektresultater fra undersøgelse 0722T0621 (ITTI-populationen) Peramivir 600 mg n = 97
English: • abnormal behaviour, delirium
Danish: • unormal adfærd, delirium
English: • The active substance is peramivir.
Danish: • Aktivt stof: peramivir.
English: Adverse Reaction According to Frequency*
Danish: Bivirkninger efter hyppighed*
English: Tell your doctor if you are pregnant or breast-feeding.
Danish: Fortæl det til lægen, hvis du er gravid eller ammer.
English: Most of the cases occurred in elderly patients with comorbidities and multiple concomitant medicinal products.
Danish: De fleste af tilfældene forekom hos ældre patienter med komorbiditeter, som samtidigt tog flere andre lægemidler.
English: There is no preservative or antibacterial agent in the solution.
Danish: Der er ingen konserveringsmidler eller antibakterielle stoffer i opløsningen.
English: Table 3: Adverse reactions in studies investigating peramivir for treatment of uncomplicated influenza in adults
Danish: Tabel 3: Bivirkninger i undersøgelser af peramivir til behandling af ukompliceret influenza hos voksne
English: Your doctor will advise on whether you can be given Alpivab during pregnancy, or whether you are to stop breast-feeding for a short period after getting Alpivab.
Danish: Lægen vil fortælle dig, om du kan få Alpivab under graviditeten, eller om du skal holde op med at amme i en kort periode, efter du har fået Alpivab.
English: Table 5: Pharmacokinetic parameters in paediatric subjects
Danish: Tabel 5: Farmakokinetiske parametre hos pædiatriske forsøgspersoner
English: The ITTI population included 84 subjects with influenza confirmed by PCR.
Danish: ITTI-populationen omfattede 84 forsøgspersoner med influenza bekræftet ved PCR.
English: Each carton contains 3 vials.
Danish: Hver æske indeholder 3 hætteglas.
English: Alpivab is used to treat adults and children aged from 2 years with influenza that is not severe enough to require hospitalisation.
Danish: Alpivab anvendes til at behandle voksne og børn i alderen 2 år og opefter med influenza, der ikke er alvorlig nok til hospitalsindlæggelse.
English: Table 1: Peramivir dose based on age and body weight Age and body weight
Danish: Tabel 1: Dosis af peramivir baseret på alder og legemsvægt Alder og legemsvægt
English: Children aged from 2 years and <50 kg
Danish: Børn fra 2 år og < 50 kg
English: • increased level of urine ketone body
Danish: • forhøjet niveau af ketonstoffer i urinen
English: AUClast (ng•h/mL)
Danish: AUClast (ng•t/ml)
English: Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH03
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, neuraminidase-inhibitorer, ATC-kode: J05AH03
English: Recommended single dose 600 mg
Danish: Anbefalet enkeltdosis 600 mg
English: Crossresistance between peramivir and each of oseltamivir and zanamivir may also occur.
Danish: Krydsresistens mellem peramivir og oseltamivir og mellem peramivir og zanamivir kan også forekomme.
English: CI = Confidence Interval
Danish: KI = konfidensinterval
English: From a microbiological point of view, the product, once diluted, should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør lægemidlet efter fortynding anvendes med det samme.
English: If any hypersensitivity reaction occurs during infusion of peramivir, the infusion must be stopped immediately and appropriate management should be instituted.
Danish: Hvis der opstår overfølsomhedsreaktioner under infusionen af peramivir, skal infusionen stoppes øjeblikkeligt, og relevant behandling bør iværksættes.
English: You must not receive Alpivab
Danish: Du må ikke få Alpivab
English: Renal clearance of unchanged peramivir accounts for approximately 90 % of total clearance.
Danish: Udskillelse af uomdannet peramivir gennem nyrerne står for ca. 90 % af den samlede clearance.
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsberetninger (PSUR'er)
English: Following intravenous administration of a single dose of peramivir 600 mg over 30 minutes, Cmax was reached at the end of infusion.
Danish: Efter intravenøs administration af en enkeltdosis peramivir 600 mg over 30 minutter blev Cmax nået ved slutningen af infusionen.
English: Marketing Authorisation Holder BioCryst Ireland Limited Atlantic Avenue
Danish: Indehaver af markedsføringstilladelsen BioCryst Ireland Limited Atlantic Avenue
English: Delirium, hallucinations and abnormal behaviour have been reported in patients with influenza who were receiving peramivir.
Danish: Delirium, hallucinationer og unormal adfærd er blevet indberettet hos patienter med influenza, der fik peramivir.
English: Efficacy (time to resolution of fever; time to resolution of influenza symptoms, viral shedding, virus susceptibility) was a secondary endpoint.
Danish: Virkningen (tid til forsvinden af feber; tid til forsvinden af influenza-symptomer, viral shedding, virusfølsomhed) var et sekundært endepunkt.
English: At enrollment 85 % of the 296 subjects had a composite influenza symptom score <15.
Danish: Ved rekruttering havde 85 % af de 296 forsøgspersoner en sammensat influenzasymptomscore på < 15.
English: Subjects receiving peramivir experienced a median time to alleviation of their combined influenza symptoms of 79.0 hours and the median time to recovery to normal temperature (less than 37 °C) was approximately 40.0 hours.
Danish: Forsøgspersoner, der fik peramivir, oplevede en median tid til lindring af deres kombinerede influenza-symptomer på 79,0 timer, og den mediane tid til genvinding af normal temperatur (mindre end 37 °C) var ca. 40,0 timer.
English: Haemodialysis initiated at 2 hours after dosing reduced systemic exposure of peramivir by 73 to 81 %.
Danish: Hæmodialyse påbegyndt 2 timer efter administration nedsatte den systemiske eksponering af peramivir med 73-81 %.
English: The major route of elimination of peramivir is via the kidney.
Danish: Den væsentligste eliminationsvej for peramivir er gennem nyrerne.
English: The pharmacokinetic parameters following intravenous (IV) administration of peramivir (0.17 to 2 times the recommended dose) showed a linear relationship between dose and exposure parameters (maximum serum concentration [Cmax] and area under the curve [AUC]).
Danish: De farmakokinetiske parametre efter intravenøs administration af peramivir (0,17-2 gange den anbefalede dosis) viste et lineært forhold mellem dosis og eksponeringsparametre (maksimal serumkoncentration [Cmax] og areal under kurven [AUC]).
English: The following steps should be followed to prepare a diluted solution of peramivir:
Danish: Følgende trin skal følges for at klargøre en fortyndet opløsning af peramivir:
English: Alpivab is given by a healthcare profesional as a single dose within 2 days of the start of influenza symptoms.
Danish: Alpivab gives af en sundhedsperson som en enkeltdosis inden for 2 dage efter starten på influenzasymptomer.
English: Alpivab contains the active substance peramivir which belongs to a group of medicines called neuraminidase inhibitors.
Danish: Alpivab indeholder det aktive stof peramivir, der tilhører en gruppe af lægemidler kaldet neuraminidase-hæmmere.
English: The mean temperature at enrolment was 38.6 °C (axillary).
Danish: Den gennemsnitlige temperatur ved rekruttering var 38,6 °C (målt i armhulen).
English: The pharmacokinetics in elderly subjects was similar to non-elderly subjects.
Danish: Farmakokinetikken hos ældre forsøgspersoner var omtrent den samme som hos ikkeældre forsøgspersoner.
English: The recommended single intravenous dose of peramivir depends on age and body weight as shown in Table 1.
Danish: Den anbefalede intravenøse enkeltdosis af peramivir afhænger af alder og legemsvægt, jf. tabel 1.
English: Live attenuated influenza vaccines are not recommended to be used until 48 hours following Alpivab administration due to a theoretical risk that peramivir could reduce the immunogenicity of the vaccine.
Danish: Vacciner med levende svækket influenza anbefales ikke i de første 48 timer efter administration af Alpivab på grund af en teoretisk risiko for, at peramivir kan reducere vaccinens immunogenicitet.
English: The safety and efficacy of peramivir in children aged under 2 years has not yet been established.
Danish: Pædiatrisk population Peramivirs sikkerhed og virkning hos børn under 2 år er endnu ikke klarlagt.
English: Time to alleviation of symptoms median (hours) (95 % CI)
Danish: Tid til lindring af symptomer median (timer) (95 %-KI)
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis bruger anden medicin eller har gjort det for nylig.
English: What you need to know before you are given Alpivab 3.
Danish: Det skal du vide, før du får Alpivab 3.
English: Do not use if seal opening is broken or missing.
Danish: Anvend ikke et hætteglas, hvis forseglingen er brudt eller mangler.
English: %CV SD = Standard Deviation; CV = Coefficient of Variation
Danish: Gennemsnit (SD) Geometrisk gennemsnit % CV SD = standardafvigelse (Standard Deviation); CV = variationskoefficient
English: The efficacy of peramivir as a single dose treatment for uncomplicated influenza was demonstrated in a single placebo-controlled study conducted in 300 adult patients in Japan during the 2007/2008 influenza season.
Danish: Virkningen af en enkeltdosis peramivir mod ukompliceret influenza blev påvist i en enkelt placebokontrolleret undersøgelse af 300 voksne patienter i Japan i influenzasæsonen 2007/2008.
English: There is no experience of acute overdose with peramivir in humans.
Danish: Der er ingen erfaring med akut overdosering af peramivir hos mennesker.
English: Reduced renal function
Danish: Nedsat leverfunktion
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Alpivab in one or more subsets of the paediatric population for the treatment of influenza (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Alpivab i en eller flere undergrupper af den pædiatriske population ved behandling af influenza (se pkt.
English: Randomisation was 4:1 for peramivir and oseltamivir.
Danish: Randomisering blev foretaget i forholdet 4:1 for peramivir og oseltamivir.
English: In simulations of a single dose of 600 mg, the predicted AUC in Asians (AUC0-24 88,800 ng•h/mL) was slightly higher as compared to Non-Asians (AUC0-24 77,200 ng•h/mL).
Danish: I simuleringer af en enkeltdosis på 600 mg var den forventede AUC hos asiater (AUC0-24 88 800 ng•t/ml) lidt højere end hos ikke-asiater (AUC0-24 77 200 ng•t/ml).
English: Alpivab is not likely to change your ability to drive and use machines.
Danish: Alpivab forventes ikke at påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Time to recovery of normal temperature median (hours) (95 % CI)
Danish: Tid til genvinding af normal temperatur, median (timer) (95 %-KI)
English: Rare, may affect up to 1 in 1,000 people • severe skin rash with or without blisters and fever
Danish: Sjælden (kan forekomme hos op til 1 ud af 1 000 patienter): • alvorligt hududslæt med eller uden blæredannelse og feber
English: Alpivab is not recommended in children aged under 2 years.
Danish: Anvendelse af Alpivab frarådes til børn under 2 år.
English: Children and Adolescents from 2 years Side effects were similar to adults but also included the following: Common, may affect up to 1 in 10 people
Danish: Bivirkningerne var omtrent de samme som hos voksne, men omfattede derudover: Almindelig (kan forekomme hos op til 1 ud af 10 patienter):
English: There are insufficient clinical data available in children and adolescents aged less than 13 years or with body weight less than 50 kg with renal impairment to be able to make any dosing recommendation.
Danish: Der er ikke tilstrækkelige kliniske data for børn og unge under 13 år eller med en legemsvægt under 50 kg og nedsat nyrefunktion til at kunne fremsætte doseringsanbefalinger.
English: In a clinical trial, no statistically significant clinical benefit could be demonstrated for peramivir over placebo in patients infected with the A/H1N1 virus containing the H275Y mutation.
Danish: I en klinisk undersøgelse blev der ikke påvist nogen statistisk signifikant klinisk fordel ved peramivir over for placebo hos patienter, der var inficeret med A/H1N1-virus, der indeholdt H275Y-mutationen.
English: The mean AUC0- was increased by 28 %, 302 % and 412 % in subjects with creatinine clearance of 50-79, 30-49 and 10-29 mL/min, respectively.
Danish: Den gennemsnitlige AUC0- blev øget med hhv. 28 %, 302 % og 412 % hos forsøgspersoner med en kreatinin-clearance på hhv. 50-79, 30-49 og 10-29 ml/min.
English: • Discard any unused diluted solution of peramivir after 24 hours.
Danish: • Bortskaf eventuel ubrugt fortyndet opløsning af peramivir efter 24 timer.
English: Subjects were eligible if they had fever greater than 38 °C and a positive rapid antigen test for influenza virus, accompanied by at least two of the following symptoms: cough, nasal symptoms, sore throat, myalgia, chills/sweats, malaise, fatigue or headache.
Danish: Forsøgspersoner var egnede, hvis de havde feber over 38 °C og en positiv hurtig antigentest for influenzavirus ledsaget af mindst to af følgende symptomer: hoste, næsesymptomer, ondt i halsen, myalgi, kulderystelser/svedtendens, utilpashed, træthed eller hovedpine.
English: Inspect the Alpivab concentrate.
Danish: Kontrollér visuelt koncentratet af Alpivab.
English: Manufacturer Seqirus Vaccines Limited Gaskill Road, Speke Liverpool
Danish: Seqirus Vaccines Limited Gaskill Road, Speke Liverpool
English: The H275Y substitution is associated with reduced susceptibility to peramivir and oseltamivir.
Danish: H275Y-substitutionen er forbundet med nedsat følsomhed for peramivir og oseltamivir.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from peramivir therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med peramivir seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Other medicines and Alpivab
Danish: Brug af anden medicin sammen med Alpivab
English: Treatment was given or commenced within 48 hours of onset of symptoms of influenza.
Danish: Behandlingen blev givet eller påbegyndt inden for 48 timer efter debut af symptomer på influenza.
English: • severe allergic reactions, including severe allergic shock reaction with features such as itchy rash, swelling of the throat and tongue, breathing difficulty, lightheadedness and vomiting
Danish: • alvorlige allergiske reaktioner, herunder alvorligt allergisk chok med f.eks. kløende udslæt, hævelse i svælget og tungen, vejrtrækningsbesvær, ørhed og opkastning
English: The recommended 600 mg single intravenous dose resulted in shortening of the median time to alleviation of symptoms by 21 hours (see section 5.1).
Danish: Den anbefalede intravenøse enkeltdosis på 600 mg medførte en forkortelse af den mediane tid til symptomlindring på 21 timer (se pkt.
English: Patients with influenza and already existing diseases should be closely monitored for renal function.
Danish: Nyrefunktionen hos patienter med influenza og eksisterende sygdomme bør overvåges tæt.
English: No human data on the effect of peramivir on fertility are available.
Danish: Der foreligger ingen kliniske data om peramivirs indvirkning på fertiliteten.
English: Peramivir was not teratogenic in embryo-fetal development studies in rats and rabbits and had no effects on mating or fertility in rats up to 600 mg/kg/day, at which exposures were approximately 8-fold of those in humans at the clinically recommended dose.
Danish: Peramivir var ikke teratogent i undersøgelser af embryoføtal udvikling hos rotter og kaniner og havde ingen indvirkning på parring eller fertilitet hos rotter ved op til 600 mg/kg/dag, dvs. ved en eksponering, der var ca. 8 gange større end eksponeringen hos mennesker ved den klinisk anbefalede dosis.
English: • Visually inspect the peramivir concentrate 10 mg/mL.
Danish: • Undersøg visuelt koncentratet af peramivir 10 mg/ml.
English: The primary endpoint, time to alleviation of symptoms, was defined as the number of hours from initiation of study drug until the start of the 24 hour period in which all seven symptoms of influenza (cough, sore throat, nasal congestion, headache, feverishness, myalgia and fatigue) were either absent or present at a level no greater than mild for at least 21.5 hours.
Danish: Det primære endepunkt, tid til lindring af symptomer, blev defineret som antallet af timer fra påbegyndelse af forsøgsbehandlingen til starten på den 24-timers periode, hvori alle syv symptomer på influenza (hoste, ondt i halsen, tilstoppet næse, hovedpine, feber, myalgi og træthed) enten var væk eller kun forekom som 'milde' symptomer i mindst 21,5 timer.
English: The intent to treat influenza population (ITTI) included 296 subjects with influenza confirmed by polymerase chain reaction (PCR).
Danish: Intent-to-treat-influenzapopulationen (ITTI) omfattede 296 forsøgspersoner med influenza bekræftet ved polymerasekædereaktion (PCR).
English: Influenza A/H1N1 viruses that contain the H275Y mutation have reduced susceptibility to peramivir and oseltamivir.
Danish: Influenza A/H1N1-vira, der indeholder H275Y-mutationen, har nedsat følsomhed for peramivir og oseltamivir.
English: Among 467 adult subjects with uncomplicated influenza who received a single intravenous dose of peramivir 600 mg in clinical trials, the most commonly observed adverse reactions were neutrophil count decreased (3.2 %) and nausea (2.4 %).
Danish: Blandt 467 voksne forsøgspersoner med ukompliceret influenza, som fik en intravenøs enkeltdosis peramivir på 600 mg i kliniske undersøgelser, var de hyppigst observerede bivirkninger nedsat neutrofiltal (3,2 %) og kvalme (2,4 %).
English: Check the seal of each vial.
Danish: Tjek forseglingen på hvert hætteglas.
English: Clinical trials in which single intravenous doses of peramivir were administered to patients with uncomplicated influenza included few subjects aged 65 and over (n=10).
Danish: I de kliniske undersøgelser, hvor intravenøse enkeltdoser af peramivir blev administreret til patienter med ukompliceret influenza, var der få forsøgspersoner i alderen 65 år og derover (n = 10).
English: Alpivab is a clear, colourless, sterile concentrate for solution for infusion.
Danish: Alpivab er et klart, farveløst og sterilt koncentrat til infusionsvæske, opløsning.
English: There is no evidence for efficacy of peramivir in any illness caused by agents other than influenza viruses.
Danish: Der er ikke evidens for virkning af peramivir ved sygdomme, der skyldes andre stoffer end influenzavira.
English: Carcinogenicity studies by intravenous injection of peramivir were not performed.
Danish: Der er ikke gennemført undersøgelser af karcinogeniciteten af intravenøs injektion af peramivir.
English: No clinically relevant alterations to peramivir pharmacokinetics are expected in patients with hepatic impairment based on the route of peramivir elimination.
Danish: Der forventes ingen klinisk relevante forandringer af peramivirs farmakokinetik hos patienter med nedsat leverfunktion baseret på peramivirs eliminationsvej.
English: • abnormal sensation such as prickling, tingling and itchiness
Danish: • unormal fornemmelse såsom prikken, stikken og kløe
English: Available pharmacodynamic/toxicological data in animals have shown excretion of peramivir in milk (see section 5.3).
Danish: De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg har vist, at peramivir udskilles i mælk (se pkt.
English: In clinical trials, H275Y was the only resistance-associated treatment-emergent mutation in the neuraminidase gene that occurred in virus obtained from more than one peramivir-treated subject (in 9 of 481[1.9 %] infected with the A/H1N1 influenza virus).
Danish: I kliniske undersøgelser var H275Y den eneste resistens-associerede, behandlingsrelaterede mutation i neuraminidase-genet, der forekom i virus fra mere end én forsøgsperson behandlet med peramivir (hos 9 ud af 481 [1,9 %] forsøgspersoner inficeret med A/H1N1).
English: • acute kidney injury, reduced kidney function
Danish: • akut nyreskade, nedsat nyrefunktion
English: Each 20 mL vial contains 200 mg peramivir.
Danish: Hvert 20 ml hætteglas indeholder 200 mg peramivir.
English: Use aseptic technique during the preparation of Alpivab to prevent microbial contamination.
Danish: Brug aseptisk teknik til klargøring af Alpivab for at forhindre mikrobiel forurening.
English: In general, nephrotoxicity was observed in rabbits, no unexpected toxicity was observed, and no other target organ toxicity was identified in juvenile animals.
Danish: Der blev ikke observeret uventet toksicitet og ikke identificeret anden målorgantoksicitet hos unge dyr.
English: Discard any unused diluted solution of Alpivab after 24 hours.
Danish: Bortskaf eventuel ubrugt fortyndet opløsning af Alpivab efter 24 timer.
English: In adults and adolescents (from 13 years and 50 kg) with chronic renal impairment maintained on haemodialysis, peramivir should be administered after dialysis at a dose adjusted for renal function (Table 2).
Danish: Hos voksne og unge (fra 13 år og 50 kg) med kronisk nedsat nyrefunktion, og som er i hæmodialyse, bør peramivir administreres efter dialyse ved en dosis, der er tilpasset nyrefunktionen (se tabel 2).
English: Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin.
Danish: Symptomerne kan omfatte hævelse i huden eller svælget, vejrtrækningsproblemer, blæredannende udslæt eller afskallende hud.
English: The pharmacokinetics of peramivir has been evaluated in a study in paediatric subjects 2 to 17 years of age with uncomplicated influenza.
Danish: Peramivirs farmakokinetik er vurderet i en undersøgelse af pædiatriske forsøgspersoner i alderen 217 år med ukompliceret influenza.
English: This medicine contains 212.4 mg sodium (main component of cooking/table salt) in each dose consisting of 3 vials.
Danish: Dette lægemiddel indeholder 212,4 mg natrium (den primære bestanddel i køkkensalt) i en dosis bestående af 3 hætteglas.
English: Live attenuated influenza vaccines should not be given until 48 hours after treatment with Alpivab.
Danish: Vaccination med levende, svækkede influenzavira bør tidligst gives 48 timer efter behandling med Alpivab.
English: In a clinical trial in which 245 subjects were infected at baseline with influenza A/H1N1 containing the H275Y mutation, the median baseline IC50 values for peramivir, oseltamivir and zanamivir were 51.0 nM, 487.6 nM and 0.95 nM, respectively.
Danish: I en klinisk undersøgelse, hvor 245 forsøgspersoner ved baseline var inficeret med influenza A/H1N1 med H275Y-mutationen, var de mediane IC50-værdier for peramivir, oseltamivir og zanamivir hhv. 51,0 nM, 487,6 nM og 0,95 nM ved baseline.