FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH01
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, neuraminidase-inhibitorer ATC-kode: J05AH01
English: The serum half-life of zanamivir increases to approximately 12-20 hours in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Danish: Zanamivirs serumhalveringstid stiger til ca. 12-20 timer hos patienter med svær nedsat nyrefunktion (kreatininclearance < 30 ml/min.).
English: The pharmacokinetics in elderly subjects was similar to young adult subjects.
Danish: Farmakokinetikken hos ældre forsøgspersoner var den samme som hos unge voksne forsøgspersoner.
English: Reproductive studies performed in rats and rabbits indicated that placental transfer of zanamivir occurs and there was no evidence of teratogenicity.
Danish: Reproduktionsstudier hos rotter og kaniner har vist, at der forekommer placental overførsel af zanamivir, og der var ingen evidens for teratogenicitet.
English: Resistance selection during zanamivir treatment is rare.
Danish: Resistensselektion under behandling med zanamivir er sjælden.
English: The safety profile of Dectova is based primarily on data from a single Phase II and a single Phase III study, with support from Phase I studies, a compassionate use programme, and adverse drug reactions reported for inhaled zanamivir.
Danish: Dectovas sikkerhedsprofil er primært baseret på data fra et enkelt fase II- og et enkelt fase III-studie med støtte fra fase I-studier, program for anvendelse med særlig udleveringstilladelse og indberettede bivirkninger for inhaleret zanamivir.
English: Weight-based dose regimen
Danish: Vægtbaseret doseringsregime
English: This medicinal product contains 70.8 mg sodium per vial, equivalent to 3.54% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 70,8 mg natrium pr. hætteglas, svarende til 3,54 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: Results from a rat peri- and postnatal study showed no clinically meaningful impairment of offspring development.
Danish: Resultater fra et peri- og postnatalt studie med rotter viste ingen klinisk betydningsfuld svækkelse i afkommets udvikling.
English: • Discard any unused portion of the vial.
Danish: • Bortskaf en eventuel ikke anvendt del af hætteglasset.
English: Dose proportionality was observed in zanamivir Cmax and AUC and no accumulation of zanamivir in serum was evident after repeated intravenous doses of up to 600 mg.
Danish: Der blev observeret dosisproportionalitet for zanamivir Cmax og AUC, og der var ikke tegn på akkumulering af zanamivir i serum efter gentagne intravenøse doser på op til 600 mg.
English: The study did not meet its pre-specified primary objective of demonstrating superiority of 600 mg zanamivir to oral oseltamivir or to 300 mg zanamivir in TTCR.
Danish: Studiet nåede ikke det foruddefinerede primære mål om påvisning af superioritet for 600 mg zanamivir i forhold til oral oseltamivir eller til 300 mg zanamivir i TTCR.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Dectova in one or more subsets of the paediatric population in the treatment and prevention 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 Dectova i en eller flere undergrupper af den pædiatriske population ved behandling og forebyggelse af influenza (se pkt.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Danish: Bivirkningernes hyppighed er defineret ved hjælp af følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til <
English: INFORMATION FOR HEALTHCARE PROFESSIONALS
Danish: OPLYSNINGER TIL LÆGER OG SUNDHEDSPERSONALE
English: Neuropsychiatric events, including seizures, delirium, hallucination and abnormal behaviour, have been reported during administration of zanamivir in patients with influenza, especially in children and adolescents.
Danish: Der er rapporteret neuropsykiatriske hændelser, herunder krampeanfald, delirium, hallucination og unormal adfærd, under administration af zanamivir hos patienter med influenza, især hos børn og unge.
English: • serum zanamivir levels from patients with complicated influenza (see section 5.1).
Danish: • niveauet af zanamivir i serum fra patienter med kompliceret influenza (se pkt.
English: This medicine contains 70.8 mg sodium (main component of cooking/table salt) in each vial.
Danish: Dette lægemiddel indeholder 70,8 mg natrium (hovedkomponenten i madlavnings-/bordsalt) pr. hætteglas.
English: The frequency of adverse reactions is based on the number of reports in the adult population receiving zanamivir 600 mg twice daily intravenously in the Phase II and Phase III studies.
Danish: Bivirkningernes hyppighed er baseret på antallet af indberetninger hos den voksne population, der fik zanamivir 600 mg 2 gange dagligt intravenøst, i fase II- og fase III-studierne.
English: • levels of zanamivir in broncho-epithelial lining fluid and serum zanamivir from a broncho-alveolar lavage study;
Danish: • niveauet af zanamivir i bronkieepitelvæske og serum-zanamivir fra et studie af bronkoalveolær lavage
English: Each vial contains 3.08 mmol (70.8 mg) sodium.
Danish: Hvert hætteglas indeholder 3,08 mmol (70,8 mg) natrium.
English: Zanamivir is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from the plasma membrane of infected cells and promotes virus spread in the respiratory tract.
Danish: Zanamivir er en hæmmer af influenzavirusneuraminidase, et enzym, der frigiver viruspartikler fra plasmamembranen på inficerede celler og fremmer spredningen af virus i luftvejene.
English: The efficacy of Dectova for the treatment of complicated influenza A or B virus infection in adults and children aged from 6 months has been inferred from:
Danish: Dectovas virkning til behandling af kompliceret influenza A- eller B-virusinfektion hos voksne og børn fra 6 måneder er udledt af:
English: The clinical impact of reduced susceptibility in these viruses is unknown, and the effects of specific substitutions on virus susceptibility to zanamivir may be strain-dependent.
Danish: Den kliniske påvirkning fra nedsat følsomhed i disse vira er ukendt, og virkningen af specifikke substitutioner på virusfølsomheden over for zanamivir afhænger muligvis af stammen.
English: Serious skin or allergic reactions may occur after Dectova is given.
Danish: Der kan forekomme alvorlige hudreaktioner og allergiske reaktioner, efter at du har fået Dectova.
English: Table 1: Weight-based dose regimen by age for infants, children and adolescents with normal renal function
Danish: Tabel 1: Vægtbaseret doseringsregime efter alder til spædbørn, børn og unge med normal nyrefunktion
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLIGE VILKÅR
English: • very severe skin reactions such as: o a skin rash, which may blister, and looks like small targets (erythema multiforme) o a widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) o extensive peeling of the skin on much of the body surface (toxic epidermal necrolysis).
Danish: • meget svære hudreaktioner såsom: o hududslæt, der kan danne blærer, som ligner små målskiver (erythema multiforme) o udbredt udslæt med blærer og afskallende hud, der især forekommer omkring munden, næsen, øjnene og kønsorganerne (Stevens-Johnsons syndrom) o omfattende afskalning af huden på meget af kroppens overflade (toksisk epidermal nekrolyse).
English: GM %CV GM %CV GM Range
Danish: GM %CV GM %CV GM Interval
English: Neuraminidase inhibition occurred at very low zanamivir concentrations in vitro, with median inhibitory (IC50) values of 0.33 nM to 5.77 nM against influenza A and B strains respectively.
Danish: Neuraminidase-hæmning forekom ved meget lave koncentrationer af zanamivir in vitro, med mediane hæmningsværdier (IC50) på 0,33 nM til 5,77 nM mod henholdsvis influenza A- og B-stammer.
English: Reduced susceptibility to zanamivir is associated with mutations that result in amino acid changes in the viral neuraminidase or viral hemagglutinin or both.
Danish: Nedsat følsomhed over for zanamivir er forbundet med mutationer, der medfører aminosyreændringer i den virale neuraminidase eller den virale hæmagglutinin eller begge.
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Danish: For opbevaringsbetingelser efter fortynding af lægemidlet, se pkt.
English: Treatment with Dectova should commence as soon as possible and usually within 6 days of the onset of symptoms of influenza (see section 5.1).
Danish: Behandling med Dectova skal påbegyndes hurtigst muligt og sædvanligvis inden for 6 dage efter debut af influenzasymptomer (se pkt.
English: 6 months - <1 year mg/kg
Danish: måneder - < 1 år mg/kg
English: Bronchoalveolar lavage study
Danish: Studie af bronkoalveolær lavage
English: Zanamivir had a significant prophylactic effect against an experimental challenge with influenza A virus as demonstrated by the low infection rate (14% vs. 100% positive serology in placebo group, p <0.005), isolation of virus by viral culture (0% vs. 100% in placebo group, p <0.005), as well as reductions in fever (14% vs. 88% in placebo group, p <0.05), upper respiratory tract illness (0% versus 100% in placebo group, p<0.005) and total symptom scores (1 vs. 44 median score in placebo group, p<0.001).
Danish: Zanamivir havde en signifikant profylaktisk effekt mod en forsøgsprovokation med influenza A-virus, der blev påvist af den lave infektionsrate (14 % vs. 100 % positiv serologi i placebogruppen, p < 0,005) og isolation af virus via viruskultur (0 % vs. 100 % i placebogruppen, p < 0,005) samt reduktioner i feber (14 % vs. 88 % i placebogruppen, p < 0,05), sygdom i de øvre luftveje (0 % vs. 100 % i placebogruppen, p < 0,005) og den samlede symptomscore (1 vs. 44 medianscore i placebogruppen, p < 0,001).
English: • The volume of Dectova and total volume for infusion will depend on the patient's age, weight and renal function (see section 4.2).
Danish: • Volumen af Dectova og det samlede volumen til infusion afhænger af patientens alder, vægt og nyrefunktion (se pkt.
English: Psychiatric disorders abnormal behaviour hallucinations delirium not known
Danish: Unormal adfærd Hallucinationer Delirium
English: EU/1/18/1349/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1349/001
English: See the end of section 4 for how to report side effects.
Danish: Se sidst i <afsnit> <punkt> 4, hvordan <De> <du> indberetter bivirkninger.
English: Neuraminidase substitutions conferring reduced susceptibility to zanamivir have emerged during treatment with zanamivir in human viruses and those with zoonotic potential: E119D, E119G, I223R, R368G, G370D, N434S (A/H1N1); N294S, T325I (A/H3N2); R150K (B); R292K (A/H7N9).
Danish: Neuraminidasesubstitutioner, der giver nedsat følsomhed over for zanamivir, er fremkommet under behandling med zanamivir i humane vira og vira med zoonotisk potentiale: E119D, E119G, I223R, R368G, G370D, N434S (A/H1N1); N294S, T325I (A/H3N2); R150K (B); R292K (A/H7N9).
English: In rats, zanamivir has been shown to be secreted in low amounts into milk.
Danish: Hos rotter er det påvist, at zanamivir udskilles i små mængder i mælk.
English: In vitro studies indicate that zanamivir is not an inhibitor or substrate of Breast Cancer Resistant Protein (BCRP), P-glycoprotein, Multidrug And Toxin Extrusion protein (MATE)1, MATE2-K, Organic Anion Transporter (OAT)1, OAT3, Organic Anion Transporting Polypeptide (OATP)1B1, OATP1B3 and Organic Cation Transporter (OCT)2 transporters, nor is it an inhibitor of cytochrome P450 (CYP) enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4.
Danish: In vitro studier indikerer, at zanamivir ikke er en hæmmer eller substrat af brystkræftresistent protein (BCRP), P-glycoprotein, Multidrug- og Toxin Extrusion protein (MATE) 1, MATE2-K, organisk aniontransporter (OAT)1, OAT3, organisk Aniontransporterende polypeptid (OATP)1B1, OATP1B3 og organiske kationtransporter (OCT)2-transportører, og det er heller ikke en hæmmer af cytokrom P450 (CYP) enzymer CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 og 3A4.
English: T1/2 (h)
Danish: T1/2
English: Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when:
Danish: Dectova er indiceret til behandling af kompliceret og muligvis livstruende influenza A- eller Bvirusinfektion hos voksne og børn (≥ 6 måneder) når:
English: • severe allergic reactions, including features such as itchy rash, swelling of the face, throat or tongue, breathing difficulty, light headedness and vomiting.
Danish: • alvorlige allergiske reaktioner, herunder kløende udslæt, hævelse af ansigt, hals eller tunge, vejrtrækningsbesvær, svimmelhed og opkastning.
English: There is no evidence that zanamivir is metabolised.
Danish: Der er ingen evidens for, at zanamivir metaboliseres.
English: Common side effects that may show up in your blood tests: • increase in the level of liver enzymes (raised aminotransferases).
Danish: Almindelige bivirkninger, der muligvis kan ses i dine blodprøver: • øget niveau af leverenzymer (øgede aminotransferaser).
English: In the population pharmacokinetic analysis, age had no significant effect on the pharmacokinetics of zanamivir.
Danish: I den populationsfarmakokinetiske analyse fandt man, at alder ikke havde en signifikant effekt på zanamivirs farmakokinetik.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Driving and using machines Dectova should not affect your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed Dectova bør ikke påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: The adverse reaction profile in the paediatric population is based on 71 patients aged ≥6 months to <18 years in the Phase II study.
Danish: Bivirkningsprofilen i den pædiatriske population er baseret på 71 patienter i alderen ≥6 måneder til
English: Hospitalised patients with influenza also have received 300 mg or 600 mg twice daily for 5 to 10 days.
Danish: Indlagte patienter med influenza fik også 300 mg eller 600 mg to gange dagligt i 5 til 10 dage.
English: Other ingredients are sodium chloride and water for injections.
Danish: Øvrige indholdsstoffer: natriumchlorid og vand til injektionsvæsker.
English: Dectova contains sodium
Danish: Dectova indeholder natrium
English: Zanamivir is not a substrate, inhibitor or inducer of cytochrome P450 isoenzymes nor a substrate or inhibitor of renal and hepatic transporters at clinically relevant concentrations (see section 5.2).
Danish: Zanamivir er ikke et substrat, en hæmmer eller inducer af cytokrom P450-isoenzymer og heller ikke et substrat eller en hæmmer af nyre- og levertransportører ved klinisk relevante koncentrationer (se pkt.
English: Anaphylactic reactions and serious skin reactions (including erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with zanamivir (see section 4.8).
Danish: Der er rapporteret anafylaktiske reaktioner og alvorlige hudreaktioner (herunder erythema multiforme, toksisk epidermal nekrolyse og Stevens-Johnsons syndrom) med zanamivir (se pkt.
English: Dectova must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dectova må ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: 50 to <80
Danish: 50 til < 80
English: A number of neuraminidase amino acid substitutions that arise during oseltamivir or peramivir treatment result in reduced susceptibility to zanamivir.
Danish: En række neuraminidaseaminosyresubstitutioner, der fremkommer under behandling med oseltamivir eller peramivir, medfører nedsat følsomhed over for zanamivir.
English: The primary endpoint was time to clinical response (TTCR); clinical response was defined as a composite of vital sign stabilisation (temperature, oxygen saturation, respiratory status, heart rate and systolic blood pressure) or hospital discharge.
Danish: Klinisk respons var defineret som en sammensætning af stabilisering af vitale tegn (temperatur, iltmætning, respiratorisk status, hjertefrekvens og systolisk blodtryk) eller udskrivning fra hospitalet.
English: A double-blind, randomised study to examine the prophylactic antiviral activity and efficacy of repeat dose zanamivir 600 mg every 12 hours intravenously compared to placebo in healthy male volunteers against infection from inoculation with influenza A/Texas/91 (H1N1) virus was conducted.
Danish: Der er udført et dobbeltblindet, randomiseret studie til undersøgelse af den profylaktiske antivirale aktivitet og virkning af gentagne doser af zanamivir 600 mg intravenøst hver 12. time sammenlignet med placebo hos raske mandlige frivillige mod infektion fra inokulation med influenza A/Texas/91 (H1N1)-virus.
English: 15 to <30
Danish: 15 til < 30
English: The serum pharmacokinetics of zanamivir administered intravenously have been studied in healthy volunteers receiving single escalating doses from 1 to 1200 mg and repeated doses of 600 mg twice daily for 5 days.
Danish: Serumfarmakokinetikken for zanamivir administreret intravenøst er blevet undersøgt hos raske frivillige, der fik enkeltdoser fra 1 til 1200 mg ved optrapning og gentagne doser på 600 mg to gange dagligt i 5 dage.
English: Dose N Cmax (g/mL)
Danish: Dosis N Cmax (µg/ml)
English: Dectova is a clear, colourless solution for infusion containing 200 mg zanamivir (as hydrate) in 20 mL.
Danish: Dectova er en klar, farveløs opløsning til infusion, der indeholder 200 mg zanamivir (som hydrat) i 20 ml.
English: Cross-resistance between zanamivir and oseltamivir or peramivir has been observed in neuraminidase inhibition assays.
Danish: Der er observeret krydsresistens mellem zanamivir og oseltamivir eller peramivir i analyser af neuraminidase-hæmning.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON
English: Preparation of Dectova
Danish: Klargøring af Dectova
English: 26 mL clear vial (type I glass) with a stopper (coated chlorobutyl rubber), an over-seal (aluminium) and a plastic flip-off cap.
Danish: 26 ml klart hætteglas (type I-glas) med prop (belagt chlorobutylgummi), ekstra forsegling (aluminium) og et fliplåg af plastik.
English: During treatment with Dectova, changes in behaviour such as confusion and unresponsiveness may occur.
Danish: Pludselige ændringer i adfærd, hallucinationer og anfald Under behandling med Dectova kan der forekomme ændringer i adfærd såsom forvirring og passivitet.
English: What you need to know before you are given Dectova
Danish: Det skal du vide, før du får Dectova
English: Uncommon side effects that may show up in your blood tests: • increase in the level of liver or bone enzymes (raised alkaline phosphatase).
Danish: Ikke almindelige bivirkninger, der muligvis kan ses i dine blodprøver: • øget niveau af lever- eller knogleenzymer (øget alkalisk phosphatase).
English: • The dose can be infused as supplied or diluted in sodium chloride 9 mg/mL (0.9%) solution for injection down to any concentration greater than or equal to 0.2 mg/mL.
Danish: • Dosis kan infunderes som leveret eller fortyndes i natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning til enhver koncentration, der er større end eller lig med 0,2 mg/ml.
English: The pharmacokinetics of zanamivir following a twice daily intravenous dose of 14 mg/kg for paediatric patients between 6 months and <6 years and 12 mg/kg for those between 6 years and <18 years of age were similar to those seen in adults who received 600 mg twice daily intravenously.
Danish: Zanamivirs farmakokinetik efter en intravenøs dosis på 14 mg/kg to gange dagligt til pædiatriske patienter mellem 6 måneder og < 6 år og 12 mg/kg til pædiatriske patienter mellem 6 år og < 18 år var den samme, som blev observeret hos voksne, der fik 600 mg intravenøst to gange dagligt.
English: A Phase I, open-label study to evaluate serum and lower respiratory pharmacokinetics following administration of intravenous and inhaled zanamivir to healthy adult subjects utilising bronchoalveolar lavage fluid was conducted.
Danish: Der er udført et åbent fase I-studie til vurdering af farmakokinetikken i serum og de nedre luftveje efter administration af intravenøs og inhaleret zanamivir til raske voksne forsøgspersoner, der anvender bronkoalveolær udskylningsvæske.
English: 12 mg/kg twice daily up to a maximum dose of 600 mg twice daily
Danish: 12 mg/kg to gange dagligt op til en maksimal dosis på 600 mg to gange dagligt
English: Zanamivir is cleared by renal excretion and is expected to be removed by haemodialysis.
Danish: Zanamivir elimineres via renal udskillelse og formodes at blive fjernet ved hæmodialyse.
English: The clinical impact of substitutions associated with reduced susceptibility to zanamivir and other neuraminidase inhibitors is variable and may be strain-dependent.
Danish: Den kliniske påvirkning fra substitutioner forbundet med nedsat følsomhed over for zanamivir og andre neuraminidase-hæmmere varierer og afhænger muligvis af stammen.
English: The 600 mg dose given intravenously best approximated epithelial lining fluid concentrations achieved by the approved 10 mg dose of zanamivir inhalation powder which demonstrated efficacy in large clinical studies in uncomplicated influenza.
Danish: Dosen på 600 mg givet intravenøst nærmede sig mest de epitelvæskekoncentrationer, der blev opnået med den godkendte dosis på 10 mg zanamivir inhalationspulver, som har vist sig at have effekt i store kliniske studier af ukompliceret influenza.
English: AUC(0-) (g.h/mL)
Danish: AUC(0-∞) (µg.t/ml)
English: When and how Dectova is given Dectova should be given as soon as possible, usually within 6 days of the symptoms of flu appearing.
Danish: Dectova bør gives så hurtigt som muligt, normalt indenfor 6 dage efter at symptomer på influenza opstår.
English: Your doctor will decide how much Dectova is right for you.
Danish: Lægen afgør, hvor meget Dectova du skal have.
English: Adults The recommended dose is 600 mg twice daily for 5 to 10 days given by intravenous infusion.
Danish: Den anbefalede dosis er 600 mg to gange dagligt i 5 til 10 dage indgivet ved intravenøs infusion.
English: • Infusion bags may have a further overage of sodium chloride 9 mg/mL (0.9%) solution for injection included - this can also be removed if considered necessary.
Danish: • Infusionsposer kan indeholde et yderligere overskud af natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning - dette kan også fjernes, hvis det anses for nødvendigt.
English: 30 to <50
Danish: 30 til < 50
English: The pharmacokinetics of zanamivir in subjects 6 months to <18 years of age (administered standard dose of 12 mg/kg, 14 mg/kg or 600 mg according to age and body weight) and in adult subjects (administered standard dose of 600 mg) was similar (Table 7).
Danish: Zanamivirs farmakokinetik hos forsøgspersoner i alderen 6 måneder til < 18 år (administreret standarddosis på 12 mg/kg, 14 mg/kg eller 600 mg efter alder og legemsvægt) og hos voksne forsøgspersoner (administreret standarddosis på 600 mg) var den samme (tabel 7).