FrancophonIA/ELRC3.0 huggingface dataset:
English: No human data on the effect of peramivir on fertility are available.
Slovenian: Podatki o učinku peramivira na plodnost pri človeku niso na voljo.
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.
Slovenian: Preiskovanci so bili primerni, če so imeli vročino nad 38 °C in pozitiven hitri antigenski test za virus influence, kar sta spremljala vsaj dva od naslednjih simptomov: kašelj, nosni simptomi, boleče grlo, mialgija, mrzlica/potenje, splošno slabo počutje, utrujenost ali glavobol.
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).
Slovenian: V simulacijah enega samega odmerka 600 mg je bil predvideni AUC pri Azijcih (AUC0-24 88.800 ng•h/ml) nekoliko višji od AUC pri Neazijcih (AUC0-24 77.200 ng•h/ml).
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.
Slovenian: Pri preiskovancih, ki so prejeli peramivir, je bila mediana časa do ublažitve združenih simptomov influence 79 ur, mediana časa do vrnitve normalne telesne temperature (manj kot 37 °C) pa približno 40 ur.
English: Alpivab is not likely to change your ability to drive and use machines.
Slovenian: Zdravilo Alpivab nima vpliva na sposobnost vožnje in upravljanja strojev.
English: Marketing Authorisation Holder BioCryst Ireland Limited Atlantic Avenue
Slovenian: Imetnik dovoljenja za promet z zdravilom BioCryst Ireland Limited Atlantic Avenue
English: 6.6 Special precautions for disposal and other handling Aseptic technique should be used during the preparation of Alpivab to prevent inadvertent microbial contamination.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pri pripravi zdravila Alpivab je treba uporabljati aseptično tehniko, da se prepreči nenamerna mikrobna kontaminacija.
English: If not used immediately in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ºC to 8 ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če pripravljene raztopine ne uporabite takoj, je za čas shranjevanja pripravljene raztopine in za pogoje pred uporabo odgovoren uporabnik; čas ne sme biti daljši od 24 ur pri temperaturi od 2 ºC do 8 ºC, razen če je bilo redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
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.
Slovenian: V kliničnem preskušanju ni bilo mogoče dokazati statistično značilne klinične koristi peramivira pred placebom pri bolnikih, okuženih z virusom A/H1N1, ki vsebuje mutacijo H275Y.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of peramivir in milk (see section 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih so pokazali izločanje peramivira v mleku (glejte poglavje 5.3).
English: Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin.
Slovenian: Simptomi lahko vključujejo otekanje kože ali žrela, težave z dihanjem, mehurjast izpuščaj ali luščenje kože.
English: The elderly subjects enrolled were aged 65 to 79 years, with a mean age of 70.1 years, with creatinine clearance (Cockcroft-Gault calculation) CrClcg ranging from 82.8 mL/min to 197.9 mL/min.
Slovenian: Vključeni starejši preiskovanci so bili stari od 65 do 79 let, s povprečno starostjo 70,1 leta, in očistkom kreatinina (Cockcroft-Gaultova enačba) CrClcg od 82,2 ml/min do 197,9 ml/min.
English: What Alpivab is and what it is used for
Slovenian: Kaj je zdravilo Alpivab in za kaj ga uporabljamo
English: Following intravenous administration of a single dose of peramivir 600 mg over 30 minutes, Cmax was reached at the end of infusion.
Slovenian: Po intravenskem dajanju peramivira v enkratnem odmerku 600 mg v 30 minutah je bil ob koncu infuzije dosežen Cmaks.
English: Time to alleviation of symptoms median (hours) (95 % CI)
Slovenian: Čas do ublažitve simptomov mediana (v urah) (95-odstotni IZ)
English: Cross resistance
Slovenian: Navzkrižna odpornost
English: There is no experience of acute overdose with peramivir in humans.
Slovenian: Ni izkušenj z akutnim prevelikim odmerjanjem peramivira pri ljudeh.
English: Each mL of concentrate contains 0.154 millimole (mmol) sodium, which is 3.54 mg of sodium.
Slovenian: En ml koncentrata vsebuje 0,154 milimola (mmol) natrija, kar je 3,54 mg natrija.
English: The pharmacokinetics of peramivir has been evaluated in a study in paediatric subjects 2 to 17 years of age with uncomplicated influenza.
Slovenian: Farmakokinetika peramivira je bila proučevana v študiji s pediatričnimi preiskovanci z nezapleteno influenco, starimi od 2 do 17 let.
English: Use aseptic technique during the preparation of Alpivab to prevent microbial contamination.
Slovenian: Pri pripravi zdravila Alpivab uporabljajte aseptično tehniko, da preprečite mikrobno kontaminacijo.
English: The dose should be reduced for adults and adolescents (13 years and older) with absolute glomerular filtration rate (GFR) below 50 mL/min as shown in Table 2 (see sections 4.4 and 5.2).
Slovenian: Odmerek je treba zmanjšati pri odraslih in mladostnikih (13 let ali več) z absolutno hitrostjo glomerulne filtracije (GFR- glomerular filtration rate) manj kot 50 ml/min, kot je prikazano v preglednici 2 (glejte poglavji 4.4 in 5.2).
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.
Slovenian: Primarni cilj študije, ublažitev simptomov, je bila opredeljena kot število ur od uvedbe proučevanega zdravila do začetka 24-urnega obdobja, v katerem je bilo vseh sedem simptomov influence (kašelj, boleče grlo, zamašen nos, glavobol, vročičnost, mialgija in utrujenost) odsotnih ali pa so bili vsaj 21,5 ure prisotni z jakostjo, ki ni presegala blage.
English: Recommended single dose 600 mg
Slovenian: Priporočeni enkratni odmerek 600 mg
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.
Slovenian: V kliničnem preskušanju, v katerem je bilo v izhodišču 245 preiskovancev okuženih z virusom influence A/H1N1, ki je vseboval mutacijo H275Y, so bile izhodiščne mediane vrednosti IC50 za peramivir, oseltamivir in zanamivir 51,0 nM, 487,6 nM oziroma 0,95 nM.
English: What you need to know before you are given Alpivab
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Alpivab
English: • Adults and adolescents (13 years and older) receive 600 mg (3 Alpivab vials).
Slovenian: • Odrasli in mladostniki (13 let ali več) prejmejo 600 mg (3 viale zdravila Alpivab).
English: Neuropsychiatric events
Slovenian: Nevropsihiatrični dogodki
English: Limitations of the clinical data
Slovenian: Pomanjkljivosti kliničnih podatkov
English: However, in an embryo-foetal development study in rats, in which dams received continuous infusions of peramivir from day 6-17 of gestation at doses of 50, 400 or 1000 mg/kg/day, dose related increases in the incidences of reduction of the renal papillae and dilatation of the ureters were observed.
Slovenian: Vendar pa se je v študiji embrio-fetalnega razvoja na podganah, v kateri so samice od 6. do 17. dne gestacije prejemale neprekinjeno infuzijo peramivira v odmerkih 50, 400 ali 1.000 mg/kg/dan, pokazalo od odmerka odvisno povečanje incidence zmanjšanja ledvičnih papil in dilatacije sečevodov.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 3 vials
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 3 viale
English: Inspect the Alpivab concentrate.
Slovenian: Koncentrat zdravila Alpivab preglejte.
English: • Discard any unused diluted solution of peramivir after 24 hours.
Slovenian: • Vso neuporabljeno razredčeno raztopino peramivira po 24 urah zavrzite.
English: Do not mix or co-infuse Alpivab with other medicines administered into a vein.
Slovenian: Zdravila Alpivab ne mešajte in ne infundirajte v veno skupaj z drugimi zdravili.
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.
Slovenian: Za otroke in mladostnike z okvaro ledvic, mlajše od 13 let ali lažje od 50 kg, ni na voljo dovolj kliničnih podatkov, da bi lahko priporočili odmerjanje.
English: The pharmacokinetics of peramivir was evaluated in 20 elderly subjects (>65 years of age) following a single 4 mg/kg IV dose of peramivir.
Slovenian: Farmakokinetika peramivira je bila proučevana pri 20 starejših osebah (> 65 let starosti) po enkratnem intravenskem dajanju peramivira v odmerku 4 mg/kg.
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 %).
Slovenian: Pri 467 odraslih z nezapleteno influenco, ki so v kliničnih preskušanjih prejeli enkraten intravenski odmerek 600 mg peramivira, sta bila najpogosteje opažena resna neželena učinka zmanjšano število nevtrofilcev (3,2 %) in navzea (2,4 %).
English: Nervous system disorders hypoaesthesia, paraesthesia
Slovenian: Bolezni živčevja hipestezija, parestezija
English: Alpivab is not recommended in children aged under 2 years.
Slovenian: Zdravilo Alpivab se ne priporoča za zdravljenje otrok ali mladostnikov, mlajših od 2 let.
English: Unknown
Slovenian: Redek Neznano
English: Elderly No dose adjustment is required based on age (see sections 4.4 and 5.2).
Slovenian: Starejše osebe Prilagajanje odmerka glede na starost ni potrebno (glejte poglavji 4.4 in 5.2).
English: • acute kidney injury, reduced kidney function
Slovenian: • akutna poškodba ledvic, okvara delovanja ledvic
English: Study treatment was started within 48 hours of onset of symptoms.
Slovenian: Proučevano zdravljenje se je začelo v 48 urah po pojavu simptomov.
English: Alpivab is a clear, colourless, sterile concentrate for solution for infusion.
Slovenian: Zdravilo Alpivab je bister, brezbarven, sterilen koncentrat za raztopino za infundiranje.
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).
Slovenian: Klinična preskušanja, pri katerih so bolnikom z nezapleteno influenco dali enkratni intravenski odmerek peramivira, je vključeval le malo preiskovancev, starih 65 let ali več (n = 10).
English: This medicinal product contains 212.4 mg sodium per 3 vials, equivalent to 10.6% of the World Health Organization (WHO) recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: To zdravilo vsebuje 212,4 mg natrija na 3 viale, kar je enako 10,6 % največjega dnevnega vnosa natrija za odraslo osebo, ki ga priporoča Svetovna zdravstvena organizacija (SZO) in znaša 2 g.
English: Uncomplicated influenza in paediatric subjects aged 2-17 years The safety of peramivir was evaluated in a randomised, active-controlled study of 110 subjects with uncomplicated influenza who received open label treatment with a single dose of peramivir (600 mg for subjects 13 to 17 years of age and 12 mg/kg up to a maximum dose of 600 mg in subjects 2 to 12 years of age) or oral oseltamivir administered twice daily for 5 days.
Slovenian: Nezapletena influenca pri pediatričnih preiskovancih, starih od 2 do 17 let Varnost peramivira so ocenjevali v randomizirani, aktivno nadzorovani študiji s 110 preiskovanci z nezapleteno influenco, ki so prejeli odprto zdravljenje z enkratnim odmerkom peramivira (600 mg za preiskovance, stare od 13 do 17 let, ter 12 mg/kg do največjega odmerka 600 mg za preiskovance, stare od 2 do 12 let) ali peroralni oseltamivir dvakrat na dan pet dni.
English: Reduced renal function
Slovenian: Zmanjšano delovanje ledvic
English: • If a patient receives 600 mg peramivir the required volume of peramivir concentrate is 60 mL
Slovenian: • Če bo bolnik prejel 600 mg peramivira, je potreben volumen koncentrata peramivira 60 ml
English: Psychiatric disorders insomnia abnormal behaviour*, delirium*
Slovenian: Psihiatrične motnje nespečnost nenormalno vedenje*, delirij*
English: • The other ingredients are sodium chloride, water for injections, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment).
Slovenian: • Druge sestavine so natrijev klorid, voda za injekcije, klorovodikova kislina (za prilagoditev pH), natrijev hidroksid (za prilagoditev pH).
English: The most important serious adverse reactions associated with peramivir in patients are anaphylaxis and skin reactions, including erythema multiforme and Stevens-Johnson Syndrome.
Slovenian: Najpomembnejši resni neželeni učinki pri bolnikih, zdravljenih s peramivirom, so anafilaksija in kožne reakcije, vključno z multiformnim eritemom in Stevens-Johnsonovim sindromom.
English: • Children aged from 2 years weighing less than 50 kg receive 12 mg per kg body weight.
Slovenian: • Otroci, starejši od dveh let in lažji od 50 kg, prejmejo 12 mg na kilogram telesne mase.
English: Tell your doctor immediately if you experience serious skin or allergic reactions after Alpivab is given.
Slovenian: Nemudoma obvestite svojega zdravnika, če se pri vas po dajanju zdravila Alpivab pojavi resna kožna ali alergijska reakcija.
English: Alpivab contains the active substance peramivir which belongs to a group of medicines called neuraminidase inhibitors.
Slovenian: Zdravilo Alpivab vsebuje učinkovino peramivir, ki spada v skupino zdravil, imenovanih zaviralci nevraminidaze.
English: Tell your doctor immediately if you experience abnormal behaviour after Alpivab is given.
Slovenian: Nemudoma obvestite svojega zdravnika, če se pri vas po dajanju zdravila Alpivab pojavi nenormalno vedenje.
English: Neuraminidase inhibition occurred at very low peramivir concentrations in-vitro, with median inhibitory concentration 50% (IC50) values of 0.13 nanomolar (nM) to 0.99 nM against influenza A and B strains.
Slovenian: In vitro je do zaviranja nevraminidaze prišlo pri zelo nizkih koncentracijah peramivira, pri vrednosti mediane inhibitorne koncentracije 50 % (IC50) proti sevom influence A in B od 0,13 nanomolov (nM) do 0,99 nM.
English: Exposure (AUC0-12) to peramivir following a single dose was approximately 33 % higher in elderly subjects compared to young adults (61,334 vs. 46,200 ng•hr/mL, respectively).
Slovenian: Izpostavljenost (AUC0-12) peramiviru po enkratnem odmerku je bila pri starejših preiskovancih za približno 33 % višja kot pri mlajših odraslih (61.334 v primerjavi z 46.200 ng•hr/mL).
English: Each 20 mL vial contains 200 mg peramivir.
Slovenian: Ena viala z 20 ml vsebuje 200 mg peramivira.
English: Influenza A/H1N1 viruses that contain the H275Y mutation have reduced susceptibility to peramivir and oseltamivir.
Slovenian: Virusi influence A/H1N1, ki vsebujejo mutacijo H275Y, so na peramivir in oseltamivir manj občutljivi.
English: Skin and subcutaneous tissue disorders dermatitis, drug eruption, eczema, urticaria erythema multiforme dermatitis exfoliative*, Stevens-Johnson syndrome*
Slovenian: Bolezni kože in podkožja dermatitis, medikamentni izpuščaj, ekcem, urtikarija multiformn i eritem eksfoliativni dermatitis*, StevensJohnsonov sindrom*
English: The pharmacokinetics of peramivir following a 600 mg intramuscular (IM) injection was similar in males and females with AUC0-∞ of 76,600 ng•hr/mL and 101,000 ng•hr/mL, respectively, and Cmax of 27,760 ng/mL and 34,710 ng/mL, respectively.
Slovenian: injekciji 600 mg je bila pri moških in ženskah podobna, z AUC0-∞ 76.600 ng•h/ml oziroma 101.000 ng•h/ml ter Cmaks 27.760 ng/ml oziroma 34.710 ng/ml.
English: The elimination half-life of peramivir following IV administration to healthy subjects of 600 mg as a single dose is approximately 20 hours.
Slovenian: Razpolovni čas izločanja peramivira po intravenskem dajanju zdravim preiskovancem v enkratnem odmerku 600 mg je približno 20 ur.
English: Table 2: Peramivir dose for adults and adolescents (from 13 years and 50 kg) based on absolute GFR Absolute Glomerular Filtration Rate (GFR)*
Slovenian: Preglednica 2: Odmerek peramivira za odrasle in mladostnike (stare 13 let ali več in težke 50 kg ali več) glede na absolutni GFR Absolutna hitrost glomerulne filtracije (GFR)*
English: Treatment was given or commenced within 48 hours of onset of symptoms of influenza.
Slovenian: Zdravljenje so prejeli oziroma začeli v 48 urah po pojavu simptomov influence.
English: Alpivab should be administered as a single intravenous dose within 48 hours of the onset of symptoms of influenza.
Slovenian: Zdravilo Alpivab je treba dati v enkratnem intravenskem odmerku v 48 urah po pojavu simptomov influence.
English: Acute renal necrosis was found in rabbits at doses ≥ 200 mg/kg with a clear no observed adverse effect level (NOAEL) established in multiple studies at 100 mg/kg/day.
Slovenian: Pri kuncih je bila pri odmerkih ≥ 200 mg/kg ugotovljena akutna ledvična nekroza z jasno koncentracijo brez opaženih neželenih učinkov (NOAEL), z več študijami določeno na 100 mg/kg/dan.
English: Dilute the required dose of Alpivab concentrate in sodium chloride 9 mg/mL (0.9 %) or 4.5 mg/mL (0.45 %) solution for infusion, 5 % dextrose or Ringer lactate solution to a volume of 100 mL.
Slovenian: Potrebni odmerek koncentrata zdravila Alpivab razredčite v raztopini natrijevega klorida 9 mg/ml (0,9 %) ali 4,5 mg/ml (0,45 %) za infundiranje, 5-odstotni dekstrozi ali Ringerjevem laktatu do prostornine 100 ml. 6.
English: UNITED KINGDOM
Slovenian: VELIKA BRITANIJA
English: Alpivab is given by a healthcare profesional as a single dose within 2 days of the start of influenza symptoms.
Slovenian: Zdravilo Alpivab dajejo zdravstveni delavci v enkratnem odmerku v največ dveh dneh po pojavu simptomov gripe.
English: Pharmacokinetics of peramivir in subjects 2 to 17 years of age (administered 12 mg/kg or 600 mg according to age and body weight) and in healthy adults (administered 600 mg) was similar (Table 5).
Slovenian: Farmakokinetika peramivira je bila podobna pri preiskovancih, starih od 2 do 17 let (ki so prejeli 12 mg/kg ali 600 mg, odvisno od starosti in telesne mase), in pri zdravih odraslih (ki so prejeli 600 mg) (preglednica 5).
English: Common, may affect up to 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
English: What Alpivab looks like and contents of the pack
Slovenian: Izgled zdravila Alpivab in vsebina pakiranja
English: • nausea (feeling sick), vomiting
Slovenian: • navzea (siljenje na bruhanje), bruhanje
English: Pack size of 3 single-use vials.
Slovenian: Velikost pakiranja: 3 viale za enkratno uporabo.
English: Mean (SD) Geometric Mean %CV
Slovenian: Srednja vrednost (SD) Geometrijska sredina % CV
English: Peramivir is cleared by renal excretion and can be cleared by haemodialysis.
Slovenian: Peramivir se izloča prek ledvic in se ga lahko odstranjuje s hemodializo.
English: Blood and lymphatic system disorders neutrophil count decreased
Slovenian: Bolezni krvi in limfatičnega sistema zmanjšano število nevtrofilcev
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mL vial of concentrate contains 200 mg peramivir.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena viala z 20 ml koncentrata vsebuje 200 mg peramivira.
English: You must not receive Alpivab
Slovenian: Zdravila Alpivab ne smete prejeti,
English: Available information on influenza drug susceptibility should be taken into account when deciding whether to use peramivir (see section 5.1).
Slovenian: Pri odločanju o uporabi peramivira je treba upoštevati razpoložljive podatke o občutljivosti na zdravila proti influenci (glejte poglavje 5.1).
English: Uncommon, may affect up to 1 in 100 people
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: Discard any unused diluted solution of Alpivab after 24 hours.
Slovenian: Vso neuporabljeno razredčeno raztopino zdravila Alpivab po 24 urah zavrzite.
English: Children aged from 2 years and <50 kg
Slovenian: Otroci, starejši od dveh let in lažji od 50 kg
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.
Slovenian: Povprečni AUC0- je bil pri osebah z očistkom kreatinina 50-79, 30-49 oziroma 10-29 ml/min večji za 28 %, 302 % oziroma 412 %.
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).
Slovenian: Pri odraslih in mladostnikih (starih 13 let ali več in težkih 50 kg ali več) s kronično okvaro ledvic, ki se zdravijo s hemodializo, se sme peramivir dati po dializi v odmerku, prilagojenem ledvičnemu delovanju (preglednica 2).
English: A randomised, multicentre, double-blind trial conducted in Japan evaluated a single intravenous administration of peramivir 300 mg or 600 mg, or placebo administered over 30 minutes in subjects 20 to 64 years of age with uncomplicated influenza.
Slovenian: V randomiziranem, multicentričnem, dvojno slepem preskušanju, ki je bilo izvedeno na Japonskem, so ocenjevali enkratno intravensko dajanje 300 ali 600 mg peramivira, ki so ga v 30 minutah prejeli preiskovanci z nezapleteno influenco, stari od 20 do 64 let.
English: Hepatic impairment No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Slovenian: Okvara jeter Pri bolnikih z okvaro jeter prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
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.
Slovenian: V študijah embrio-fetalnega razvoja na podganah in kuncih peramivir ni bil teratogen in v odmerkih do 600 mg/kg/dan, pri katerih je bila izpostavljenost približno osemkrat večja kot pri človeku pri klinično priporočenem odmerku, ni vplival na parjenje ali plodnost podgan.
English: Musculoskeletal and connective tissue disorders arthralgia, blood creatine phosphokinase increased
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija, zvišana raven kreatin-fosfokinaze v krvi
English: • Visually inspect the peramivir concentrate 10 mg/mL.
Slovenian: • Koncentrat peramivira 10 mg/ml vizualno preglejte.
English: 7 years - <13 years
Slovenian: 7 let-< 13 let
English: The pharmacokinetics of peramivir in subjects with hepatic impairment has not been studied.
Slovenian: Farmakokinetika peramivira pri osebah z okvaro jeter ni bila proučevana.
English: Anaphylactic reactions and serious skin reactions (including erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with peramivir (see section 4.8).
Slovenian: Pri zdravljenju s peramivirom so poročali o anafilaktičnih reakcijah in resnih kožnih reakcijah (vključno z multiformnim eritemom, toksično epidermalno nekrolizo in Stevens-Johnsonovim sindromom) (glejte poglavje 4.8).