FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: A. To se je kazalo z nizko stopnjo okužbe (14 % v primerjavi s 100 % pozitivno serologijo v skupini s placebom, p < 0,005), izolacijo virusa v virusni kulturi (0 % proti 100 % v skupini s placebom, p < 0,005), pa tudi z zmanjšanjem zvišane telesne temperature (14 % v primerjavi s 88 % v skupini s placebom, p < 0,05), bolezni zgornjih dihal (0 % v primerjavi s 100 % v skupini s placebom, p < 0,005) in celotne ocene simptomov (1 v primerjavi z mediano oceno 44 v skupini s placebom, p < 0,001).
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:
Slovenian: O učinkovitosti zdravila Dectova za zdravljenje zapletenih okužb z virusi influence A ali B pri odraslih in otrocih od 6. meseca starosti naprej je mogoče sklepati na podlagi:
English: However, there is no information on placental transfer in humans.
Slovenian: Vendar pa pri človeku ni informacij o prehajanju skozi placento.
English: A number of neuraminidase amino acid substitutions that arise during oseltamivir or peramivir treatment result in reduced susceptibility to zanamivir.
Slovenian: Številne substitucije aminokislin v nevraminidazi, ki se pojavijo med zdravljenjem z oseltamivirjem ali peramivirjem, zmanjšajo občutljivost za zanamivir.
English: Table 1: Weight-based dose regimen by age for infants, children and adolescents with normal renal function
Slovenian: Preglednica 1: Odmerna shema na podlagi telesne mase za dojenčke, otroke in mladostnike z normalnim delovanjem ledvic Razpon starosti
English: 30 to <50
Slovenian: 30 do < 50
English: EU/1/18/1349/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1349/001
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.
Slovenian: • Odmerek je mogoče infundirati, kot je opremljen, ali ga razredčiti v 0,9 % (9 mg/ml) raztopini natrijevega klorida za injekcije na katero koli koncentracijo, večjo ali enako 0,2 mg/ml.
English: What Dectova looks like and contents of the pack
Slovenian: Izgled zdravila Dectova in vsebina pakiranja
English: Zanamivir is not metabolised, therefore no effect of hepatic impairment is expected.
Slovenian: Zanamivir se ne presnavlja, zato ni pričakovati, da bi okvara jeter imela kakšen vpliv.
English: Dectova has not been studied in patients with end-stage renal disease.
Slovenian: Zdravilo Dectova ni raziskano pri bolnikih s končno odpovedjo ledvic.
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).
Slovenian: Zanamivir v klinično pomembnih koncentracijah ni substrat, zaviralec ali induktor izoencimov citokroma P450 niti substrat ali zaviralec ledvičnih in jetrnih prenašalcev (glejte poglavje 5.2).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or toxicity to reproduction and development, with the exception of a rat embryofoetal development study (subcutaneous administration).
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja in na razvoj ne kažejo posebnega tveganja za človeka, z izjemo študije embrio-fetalnega razvoja pri podganah (s subkutano uporabo).
English: Driving and using machines Dectova should not affect your ability to drive or use machines.
Slovenian: Zdravilo Dectova ne bi smelo vplivati na vašo sposobnost upravljanja vozil ali strojev.
English: Zanamivir is eliminated by renal clearance, therefore the dose of Dectova when administered intravenously must be reduced in patients with renal impairment (see section 4.2).
Slovenian: Zanamivir se izloči skozi ledvice, zato je treba bolnikom z okvaro ledvic odmerek intravensko uporabljenega zdravila Dectova zmanjšati (glejte poglavje 4.2).
English: Annual reports to be submitted
Slovenian: Predaja letnih poročil
English: Adolescents, children and infants should receive a weight-based dose regimen for 5 to 10 days (Table 1).
Slovenian: Mladostniki, otroci in dojenčki morajo od 5 do 10 dni prejemati odmerno shemo na podlagi telesne mase
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).
Slovenian: Resne preobčutljivostne reakcije Med uporabo zanamivirja so bile opisane anafilaktične reakcije in resne kožne reakcije (vključno z multiformnim eritemom, toksično epidermalno nekrolizo in Stevens-Johnsonovim sindromom) (glejte poglavje 4.8).
English: Following twice-daily administration of zanamivir solution for infusion, pulmonary epithelial lining fluid concentrations were 60 - 65 % of the serum concentrations at the corresponding sampling time 12 hours after dosing.
Slovenian: Po uporabi raztopine zanamivirja za infundiranje dvakrat na dan je bila koncentracija v tekočini sluzničnega epitelija v pljučih od 60 do 65 % koncentracije v serumu ob ustreznem času vzorčenja 12 ur po uporabi.
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.
Slovenian: Intravensko uporabljani odmerek 600 mg se je najbolje približal koncentraciji v tekočini epitelijske sluznice, doseženi z odobrenim 10-mg odmerkom zanamivirja v prašku za inhaliranje, katerega učinkovitost je bila dokazana v velikih kliničnih študijah pri nezapleteni gripi.
English: Skin and subcutaneous tissue disorders rash common urticaria uncommon erythema multiforme Stevens-Johnson syndrome toxic epidermal necrolysis not known
Slovenian: Bolezni kože in podkožja izpuščaj pogosti urtikarija občasni multiformni eritem Stevens-Johnsonov sindrom toksična epidermalna nekroliza ni znano
English: The clinical impact of substitutions associated with reduced susceptibility to zanamivir and other neuraminidase inhibitors is variable and may be strain-dependent.
Slovenian: Klinični vpliv substitucij, povezanih z manjšo občutljivostjo za zanamivir in druge zaviralce nevraminidaze, je variabilen in je lahko odvisen od seva.
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.
Slovenian: Zdravilo vsebuje 70,8 mg natrija na vialo; to ustreza 3,54 % največjega dnevnega vnosa natrija (2 g) za odrasle po priporočilu SZO.
English: • levels of zanamivir in broncho-epithelial lining fluid and serum zanamivir from a broncho-alveolar lavage study;
Slovenian: • koncentracije zanamivirja v tekočini bronhoepitelijske sluznice in v serumu v študiji bronhoalveolarne lavaže,
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.
Slovenian: Zdravilo Dectova je treba dati čim prej, po navadi v 6 dneh od pojava simptomov gripe.
English: Zanamivir solution for infusion 600 mg
Slovenian: Zanamivir raztopina za infundiranje 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.
Slovenian: Študija ni dosegla vnaprej določenega primarnega cilja, dokaza superiornosti 600 mg zanamivirja pred peroralnim oseltamivirjem ali 300 mg zanamivirja, kar zadeva čas do kliničnega odziva.
English: Reproductive studies performed in rats and rabbits indicated that placental transfer of zanamivir occurs and there was no evidence of teratogenicity.
Slovenian: Študije o sposobnosti razmnoževanja pri podganah in kuncih so pokazale, da zanamivir prehaja skozi placento; znakov teratogenosti ni bilo.
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:
Slovenian: 4.1 Terapevtske indikacije Zdravilo Dectova je indicirano za zdravljenje zapletenih in potencialno življenjsko ogrožajočih okužb z virusom influence A ali B pri odraslih in pediatričnih bolnikih (starih ≥ 6 mesecev), če:
English: Marketing Authorisation Holder GlaxoSmithKline Trading Services Limited 12 Riverwalk
Slovenian: Imetnik dovoljenja za promet z zdravilom GlaxoSmithKline Trading Services Limited Riverwalk 12
English: THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: Zanamivir solution for infusion 300 mg
Slovenian: Zanamivir raztopina za infundiranje 300 mg
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 43056 San Polo di Torrile, Parma Italy
Slovenian: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 43056 San Polo di Torrile, Parma Italija
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE
English: Like all medicines, Dectova can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Dectova neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
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.
Slovenian: Cmax in AUC zanamivirja sta kazala sorazmernost odmerku in po ponavljajočih se intravenskih odmerkih do 600 mg se zanamivir ni kopičil v serumu.
English: Hepatobiliary disorders alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increased hepatocellular injury common alkaline phosphatase increased uncommon
Slovenian: Bolezni jeter, žolčnika in žolčevodov povišana raven alanin-aminotransferaze (ALT) in/ali aspartat-aminotransferaze (AST) okvara jetrnih celic pogosti zvišanje alkalne fosfataze občasni
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.
Slovenian: faze pri 71 bolnikih, starih ≥ 6 mesecev do < 18 let.
English: GM %CV GM %CV GM Range
Slovenian: (h) GS % KV GS % KV GS Razpon GS % KV
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.
Slovenian: Zavrtje nevraminidaze se je in vitro pojavilo pri zelo nizkih koncentracijah zanamivirja; mediana inhibicijska koncentracija (IC50) je bila 0,33 nM proti sevu influence A in 5,77 nM proti sevu influence B. Odpornost
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.
Slovenian: Pri zdravih moških prostovoljcih so izvedli dvojno slepo, randomizirano študijo za proučitev profilaktičnega protivirusnega delovanja in učinkovitosti ponavljajočih se odmerkov 600 mg zanamivirja na 12 ur intravensko v primerjavi s placebom proti okužbi zaradi inokulacije z virusom influence A/Texas/91
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.
Slovenian: Študija bronhoalveolarne lavaže Izvedli so odprto študijo I. faze za ovrednotenje farmakokinetike v serumu in spodnjih dihalih po uporabi intravenskega in vdihanega zanamivirja pri zdravih odraslih; uporabljena je bila tekočina iz bronhoalveolarne lavaže.
English: There is limited experience of overdose from administration of Dectova.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila Dectova je malo.
English: Children Your doctor will decide on the correct dose of Dectova.
Slovenian: Zdravnik bo določil pravilni odmerek zdravila Dectova.
English: Begin maintenance dosing 48 hours after the initial dose *CLcr or CLCRRT units in mL/min for adolescents 13 years to less than 18 years, or in mL/min/1.73m for children 6 years to less than 13 years.
Slovenian: Vzdrževalno odmerjanje začnite 48 ur po začetnem odmerku *CLcr ali CLCRRT enote so v ml/min za mladostnike od 13. do manj kot 18. leta ali v ml/min/1,73m2 za otroke od 6. do manj kot 13. leta.
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).
Slovenian: Zdravljenje z zdravilom Dectova je treba začeti čim prej in običajno v 6 dneh po pojavu simptomov gripe
English: Serious skin or allergic reactions may occur after Dectova is given.
Slovenian: Po uporabi zdravila Dectova se lahko pojavijo resne kožne ali alergijske reakcije.
English: Children and adolescents (6 years to less than 18 years with a body weight less than 50 kg), and infants and children (6 months to less than 6 years) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) <80 mL/min should receive an initial dose followed by an appropriate twice-daily maintenance dose as shown in Tables 3, 4 and 5.
Slovenian: Otroci in mladostniki (od 6. do manj kot 18. leta in s telesno maso manj kot 50 kg) ter dojenčki in otroci (od 6. meseca do manj kot 6. leta) z očistkom kreatinina (CLcr) ali očistkom ob stalnem ledvičnem nadomestnem zdravljenju (CLCRRT) < 80 ml/min morajo prejeti začetni odmerek, ki mu sledijo ustrezni vzdrževalni odmerki dvakrat na dan, kot je prikazano v preglednicah 3, 4 in 5.
English: Zanamivir is cleared by renal excretion and is expected to be removed by haemodialysis.
Slovenian: Zanamivir se izloča skozi ledvice in pričakovati je, da se odstrani s hemodializo.
English: CLcr or CLCRRT (mL/min/1.73 m
Slovenian: CLcr ali CLCRRT (ml/min/1,73 m2)
English: Dectova 10 mg/mL solution for infusion zanamivir
Slovenian: Dectova 10 mg/ml raztopina za infundiranje zanamivir
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).
Slovenian: Farmakokinetika zanamivirja je bila pri preiskovancih, starih od 6 mesecev do < 18 let (ki so prejemali standardni odmerek 12 mg/kg, 14 mg/kg ali 600 mg glede na starost in telesno maso) in pri odraslih preiskovancih (ki so prejemali standardni odmerek 600 mg) podobna (preglednica 7).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Neporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
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.
Slovenian: Farmakokinetika zanamivirja pri pediatričnih bolnikih, starih od 6 mesecev do < 6 let med uporabo intravenskih odmerkov 14 mg/kg dvakrat na dan in starih od 6 let do < 18 let med uporabo 12 mg/kg, je bila podobna kot pri odraslih, ki so prejemali 600 mg dvakrat na dan intravensko.
English: years mg/kg
Slovenian: leti mg/kg
English: 12 mg/kg twice daily up to a maximum dose of 600 mg twice daily
Slovenian: 12 mg/kg dvakrat na dan do največjega odmerka 600 mg dvakrat na dan
English: These symptoms also occur in people with flu who are not being given Dectova.
Slovenian: Toda ti simptomi se lahko pojavijo tudi pri osebah z gripo, ki ne prejemajo zdravila Dectova, zato ni znano, ali je zdravilo Dectova imelo kakšno vlogo pri njihovem nastanku.
English: dk-info@gsk.com
Slovenian: gskcyprus@gsk.com
English: years mg/kg years mg/kg years mg years mg %CV = percent coefficient of variation, GM = Geometric Mean, NA = Not available
Slovenian: % KV = odstotni koeficient variacije, GS = geometrična sredina, NP = ni podatka
English: Adults The recommended dose is 600 mg twice daily for 5 to 10 days.
Slovenian: Priporočeni odmerek je 600 mg dvakrat na dan od 5 do 10 dni.
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).
Slovenian: I223R, R368G, G370D, N434S (A/H1N1); N294S, T325I (A/H3N2); R150K (B); R292K (A/H7N9).
English: Preparation of Dectova
Slovenian: Priprava zdravila Dectova
English: United Kingdom GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Slovenian: GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: There were no significant differences in TTCR across treatment comparisons in the overall IPP or in two prespecified subgroups (Table 6).
Slovenian: Čas do kliničnega odziva se v primerjavah zdravljenj ni značilno razlikoval ne v celotni populaciji, pozitivni za gripo, ne v vnaprej določenih podskupinah (preglednica 6).
English: Immune system disorders oropharyngeal oedema facial oedema anaphylactic/anaphylactoid reactions not known
Slovenian: Bolezni imunskega sistema orofaringealni edem edem obraza anafilaktične/anafilaktoidne reakcije ni znano
English: Dectova has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Dectova nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Solution for infusion A clear, colourless solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za infundiranje Bistra, brezbarvna raztopina za infundiranje.
English: • fits (seizures)
Slovenian: • napadi krčev (konvulzije),
English: Selection of influenza resistant viruses is more likely to occur following treatment with antiviral medicinal products in immunocompromised patients, including treatment with Dectova; it is, therefore, important to monitor for resistance and consider switching to alternative therapies where appropriate.
Slovenian: Selekcija odpornih virusov influence je bolj verjetna po zdravljenju s protivirusnimi zdravili pri imunsko oslabelih bolnikih; to velja tudi za zdravilo Dectova.
English: • Decide on the volume of sodium chloride 9 mg/mL (0.9%) solution for injection to be used for infusion.
Slovenian: • Odločite se o količini 0,9 % (9 mg/ml) raztopine natrijevega klorida za injekcije, ki jo boste uporabili za infundiranje.
English: There are limited data on zanamivir exposure during concomitant continuous renal replacement therapy and very limited data with dialysis.
Slovenian: Podatkov o izpostavljenosti zanamivirju med sočasnim stalnim ledvičnim nadomestnim zdravljenjem je malo, o izpostavljenosti med dializo pa zelo malo.
English: • Using a sterile needle and syringe, withdraw the volume of Dectova from the vial(s) and add to the infusion bag.
Slovenian: • S sterilno iglo in brizgo iz ene ali več vial izvlecite količino zdravila Dectova in jo dodajte v vrečko za infundiranje.
English: Zanamivir is not an inducer of CYP1A2 and 2B6 and, although induction of CYP3A4 in vitro was observed at 50-fold higher than the clinically relevant concentrations, no interaction with CYP3A4 substrates is expected based on physiologically based pharmacokinetic modelling.
Slovenian: 50-krat večjih od klinično pomembnih koncentracij, glede na fiziološko osnovano farmakokinetično modeliranje ni pričakovati medsebojnih delovanj s substrati CYP3A4.
English: 26 mL clear vial (type I glass) with a stopper (coated chlorobutyl rubber), an over-seal (aluminium) and a plastic flip-off cap.
Slovenian: 6.5 Vrsta ovojnine in vsebina 26-ml prozorna viala (steklo tipa I) z zamaškom (prekrita klorobutilna guma), prekrivno zaporo (aluminij) in plastično snemno zaporko.
English: Table 6: Statistical comparisons of TTCR between the 600 mg zanamivir group and each other group (IPP)
Slovenian: Preglednica 6: Statistična primerjava časa do kliničnega odziva v skupini s 600 mg zanamivirja in preostalih dveh skupinah (populacija, pozitivna za gripo)
English: CLcr or CLCRRT (mL/min or mL/min/1.73m
Slovenian: CLcr ali CLCRRT (ml/min ali ml/min/1,73m2)*
English: Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL (10 mg/mL).
Slovenian: Ena viala vsebuje 200 mg zanamivirja (v obliki hidrata) v 20 ml (10 mg/ml).
English: Neuropsychiatric events
Slovenian: Nevropsihiatrični učinki
English: Begin twice daily maintenance dosing 48 hours after the initial dose
Slovenian: Vzdrževalno odmerjanje dvakrat na dan začnite 48 ur po začetnem odmerku
English: In order to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in patients with complicated influenza infection, the MAH should submit the results of a prospective observational study in patients with complicated influenza infection.
Slovenian: Za oceno klinične učinkovitosti zdravljenja z zanamivirjem 10 mg/ml raztopina za infundiranje pri bolnikih z zapleteno okužbo gripe, mora imetnik DzP predati rezultate prospektivne opazovalne študije na bolnikih z zapleteno okužbo gripe.
English: Also contains sodium chloride, water for injections
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje tudi natrijev klorid in vodo za injekcije.
English: Table 2: Initial and maintenance dose regimens for adults and children (6 years and over with a body weight of 50 kg or above) with renal impairment
Slovenian: Preglednica 2: Shema začetnega in vzdrževalnih odmerkov za odrasle in otroke (stare 6 let ali več in s telesno maso 50 kg ali več) z okvaro ledvic
English: A Phase III, double-blind, study was conducted to evaluate the efficacy, antiviral activity and safety of zanamivir 600 mg twice daily intravenously compared to oral oseltamivir 75 mg twice daily and 300 mg zanamivir twice daily intravenously in hospitalised patients (>16 years of age) with influenza.
Slovenian: 600 mg zanamivirja dvakrat na dan intravensko v primerjavi s 75 mg oseltamivirja dvakrat na dan peroralno in 300 mg zanamivirja dvakrat na dan intravensko pri hospitaliziranih bolnikih (starih > 16 let) z gripo.
English: Following twice daily administration of 600 mg zanamivir solution for infusion, median trough zanamivir epithelial lining fluid concentrations ranged from 419 ng/mL to 584 ng/mL and were 47-66% of those in the initial bronchoalveolar sample following orally zanamivir inhalation powder 10 mg twice daily.
Slovenian: Po uporabi 600 mg zanamivirja v raztopini za infundiranje dvakrat na dan je bila najnižja mediana koncentracija zanamivirja v tekočini epitelijske sluznice od 419 ng/ml do 584 ng/ml ter je znašala od 47 do 66 %
English: The serum half-life of zanamivir increases to approximately 12-20 hours in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) se serumski razpolovni čas zanamivirja podaljša na približno 12 do 20 ur.