FrancophonIA/ELRC3.0 huggingface dataset:
English: AUC(0-) (g.h/mL)
Croatian: AUC(0-∞) (μg.h/ml)
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.
Croatian: Ispitivanja in vitro ukazuju na to da zanamivir nije inhibitor ni supstrat proteina rezistencije raka dojke (engl. breast cancer resistance protein, BCRP), P-glikoproteina, proteinskih prijenosnika za izlučivanje više lijekova i toksina (engl. multidrug and toxin extrusion protein, MATE) MATE1 i MATE2-K, prijenosnika organskih aniona (engl. organic anion transporter, OAT) OAT1 i OAT3, polipeptidnih prijenosnika organskih aniona (engl. organic anion transporting polypeptide, OATP) OATP1B1 i OATP1B3 i prijenosnika organskih kationa 2 (engl. organic cation transporter, OCT2), kao ni inhibitor enzima citokroma P450 CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 i 3A4 .
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.
Croatian: Sigurnosni profil lijeka Dectova prvenstveno se temelji na podacima iz jednog ispitivanja faze II i jednog ispitivanja faze III, a potkrijepljen je podacima iz ispitivanja faze I i programa milosrdne primjene lijeka te nuspojavama prijavljenima kod inhalacijske primjene zanamivira.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici iza oznake „EXP“.
English: In the rat embryofoetal study, there was an increase in the incidence rates of a variety of minor skeletal and visceral alterations, most of which remained within the background rates of the historical occurrence in the strain studied.
Croatian: U embriofetalnom ispitivanju na štakorima opažen je porast stopa incidencije raznih manjih koštanih i visceralnih promjena, od kojih je većina ostala unutar osnovne stope dotadašnje učestalosti kod ispitivanog soja.
English: The median patient age was 57 years and 35% (218/615) of patients were ≥65 years, of which 17% (n=103) were 65 to <75; 14% (n=84) were 75 to <85, and 5% (n=31) were ≥85 years of age.
Croatian: bilo u dobi od 65 do < 75 godina, 14% (n=84) u dobi od 75 do < 85 godina, a 5% (n=31) u dobi od ≥ 85 godina.
English: Influenza Positive Population, N Median TTCR, days
Croatian: Populacija pozitivna na gripu (IPP), N Medijan TTCR-a, dani
English: Hospitalised patients with influenza also have received 300 mg or 600 mg twice daily for 5 to 10 days.
Croatian: Hospitalizirani bolesnici s gripom također su primali dozu od 300 mg ili 600 mg dvaput na dan tijekom 5 - 10 dana.
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.
Croatian: Inhibicija neuraminidaze nastupila je pri vrlo niskim koncentracijama zanamivira in vitro, uz medijan inhibicijske koncentracije (IC50) od 0,33 nM do 5,77 nM protiv sojeva virusa gripe tipa
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).
Croatian: Zanamivir nije supstrat, inhibitor ni induktor izoenzima citokroma P450, kao ni supstrat ili inhibitor bubrežnih i jetrenih prijenosnika pri klinički relevantnim koncentracijama (vidjeti dio 5.2).
English: Animal studies indicate no clinically meaningful effects of zanamivir on male or female fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na klinički značajne učinke zanamivira na plodnost muškaraca ili žena.
English: 15 to <30
Croatian: 15 do < 30
English: Solution for infusion A clear, colourless solution for infusion.
Croatian: Otopina za infuziju Bistra, bezbojna otopina za infuziju.
English: Initial Dose Maintenance Dose Maintenance Dose Schedule
Croatian: Početna doza Doza održavanja Raspored primjene doze održavanja
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.
Croatian: Zanamivir nije induktor enzima CYP1A2 ni CYP2B6 te iako je pri koncentracijama 50 puta višima od klinički relevantnih opažena indukcija CYP3A4 in vitro, na temelju fiziološkog farmakokinetičkog modeliranja ne očekuje se interakcija sa supstratima CYP3A4.
English: Results from a rat peri- and postnatal study showed no clinically meaningful impairment of offspring development.
Croatian: Rezultati perinatalnog i postnatalnog ispitivanja na štakorima nisu pokazali klinički značajne štetne učinke na razvoj mladunčadi.
English: It is unknown whether zanamivir is excreted in human milk.
Croatian: Nije poznato izlučuje li se zanamivir u majčino mlijeko.
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).
Croatian: Kod primjene zanamivira prijavljene su anafilaktičke reakcije i ozbiljne kožne reakcije (uključujući multiformni eritem, toksičnu epidermalnu nekrolizu i Stevens-Johnsonov sindrom) (vidjeti dio 4.8).
English: T1/2 (h)
Croatian: T1/2
English: Adverse reactions are listed by MedDRA system organ class.
Croatian: Nuspojave su navedene prema MedDRA klasifikaciji organskih sustava.
English: Table 1: Weight-based dose regimen by age for infants, children and adolescents with normal renal function
Croatian: Tablica 1: Režim doziranja na temelju tjelesne težine prema dobi za dojenčad, djecu i adolescente s normalnom bubrežnom funkcijom Raspon dobi
English: In rats, zanamivir has been shown to be secreted in low amounts into milk.
Croatian: U štakora se zanamivir izlučivao u mlijeko u malim količinama.
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.
Croatian: Ovaj lijek sadrži 70,8 mg natrija po bočici, što odgovara 3,54% maksimalnog dnevnog unosa od 2 g natrija prema preporuci Svjetske zdravstvene organizacije (SZO) za odraslu osobu.
English: Do not use Dectova:
Croatian: Nemojte primiti lijek Dectova:
English: Zanamivir is eliminated unchanged in urine by glomerular filtration.
Croatian: Zanamivir se glomerularnom filtracijom eliminira kroz mokraću u nepromijenjenom obliku.
English: 30 to <50
Croatian: 30 do < 50
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.
Croatian: Ispitivanje nije postiglo unaprijed specificiran primarni cilj - dokazivanje superiornosti zanamivira u dozi od 600 mg u odnosu na oralni oseltamivir ili zanamivir u dozi od 300 mg s obzirom na TTCR.
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.
Croatian: Učestalost nuspojava temelji se na broju slučajeva prijavljenih u odrasloj populaciji koja je primala zanamivir u intravenskoj dozi od 600 mg dvaput na dan u ispitivanjima faze II i faze III.
English: A number of neuraminidase amino acid substitutions that arise during oseltamivir or peramivir treatment result in reduced susceptibility to zanamivir.
Croatian: Velik broj supstitucija aminokiselina u neuraminidazi koje nastaju tijekom liječenja oseltamivirom ili peramivirom dovodi do smanjene osjetljivosti na zanamivir.
English: years mg/kg years mg/kg years mg years mg %CV = percent coefficient of variation, GM = Geometric Mean, NA = Not available
Croatian: mg % CV = postotni koeficijent varijacije, GM = geometrijska srednja vrijednost, ND = nije dostupno
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.
Croatian: Serumska farmakokinetika intravenski primijenjenog zanamivira ispitivala se u zdravih dobrovoljaca koji su primali pojedinačne doze od 1 do 1200 mg, koje su se postupno povećavale, te ponovljene doze od 600 mg dvaput na dan tijekom 5 dana.
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.
Croatian: Lijek Dectova treba primijeniti što je prije moguće, obično unutar 6 dana od pojave simptoma gripe.
English: Dectova is a clear, colourless solution for infusion containing 200 mg zanamivir (as hydrate) in 20 mL.
Croatian: Dectova je bistra, bezbojna otopina za infuziju koja sadrži 200 mg zanamivira (u obliku hidrata) u
English: The most commonly reported adverse reactions considered possibly or probably related to Dectova are alanine aminotransferase increased (2%), aspartate aminotransferase increased (1%), hepatocellular injury (1%), diarrhoea (1%) and rash (1%).
Croatian: Dectova su povišene vrijednosti alanin aminotransferaze (2%), povišene vrijednosti aspartat aminotransferaze (1%), hepatocelularno oštećenje (1%), proljev (1%) i osip (1%).
English: The clinical impact of substitutions associated with reduced susceptibility to zanamivir and other neuraminidase inhibitors is variable and may be strain-dependent.
Croatian: Klinički utjecaj supstitucija povezanih sa smanjenom osjetljivošću na zanamivir i druge inhibitore neuraminidaze varijabilan je i mogao bi ovisiti o soju.
English: Treatment emergent resistance is rare with zanamivir (see section 5.1).
Croatian: Kod liječenja zanamivirom rijetko se razvija rezistencija (vidjeti dio 5.1).
English: Dectova has not been studied in patients with end-stage renal disease.
Croatian: Dectova se nije ispitivala u bolesnika u terminalnoj fazi bubrežne bolesti.
English: Serious skin or allergic reactions may occur after Dectova is given.
Croatian: Ozbiljne kožne ili alergijske reakcije Nakon primjene lijeka Dectova mogu se javiti ozbiljne kožne ili alergijske reakcije.
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.
Croatian: Nakon primjene zanamivira u obliku otopine za infuziju dvaput na dan, njegove koncentracije u sekretu plućnog epitela iznosile su 60 - 65% koncentracija u serumu u odgovarajućem trenutku uzorkovanja 12 sati nakon primjene.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2ºC to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Pripremljeni se lijek ne smije čuvati dulje od 24 sata na temperaturi od 2°C do 8ºC, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičnim uvjetima.
English: Reproductive studies performed in rats and rabbits indicated that placental transfer of zanamivir occurs and there was no evidence of teratogenicity.
Croatian: Ispitivanja učinaka na reprodukciju provedena na štakorima i kunićima ukazala su da zanamivir prolazi kroz posteljicu, ali nije bilo dokaza teratogenosti.
English: Dose N Cmax (g/mL)
Croatian: Doza N Cmax (μg/ml)
English: Side effects where it is not known how likely they are to happen There isn't enough information to estimate how likely these side effects are:
Croatian: Nema dovoljno informacija da bi se procijenilo koliko su vjerojatne sljedeće nuspojave:
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.
Croatian: vjerojatnija u imunokompromitiranih bolesnika, važno je pratiti bolesnike zbog mogućeg razvoja rezistencije i razmotriti prelazak na neku drugu terapiju kad je to moguće.
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.
Croatian: Provedeno je dvostruko slijepo ispitivanje faze III radi ocjene djelotvornosti, antivirusne aktivnosti i sigurnosti zanamivira u intravenskoj dozi od 600 mg dvaput na dan u odnosu na oseltamivir u peroralnoj dozi od 75 mg dvaput na dan i zanamivir u intravenskoj dozi od 300 mg dvaput na dan u hospitaliziranih bolesnika (u dobi od > 16 godina) oboljelih od gripe.
English: Driving and using machines Dectova should not affect your ability to drive or use machines.
Croatian: Dectova ne bi trebala utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: • clinical and virological activity of zanamivir compared to placebo in a human influenza challenge study;
Croatian: • kliničke i virološke aktivnosti zanamivira u usporedbi s placebom u ispitivanju izlaganja virusu gripe provedenom u ljudi
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.
Croatian: Opaženo je da su Cmax i AUC zanamivira bili proporcionalni dozi, a nakon ponovljene primjene intravenskih doza do 600 mg nije primijećena akumulacija zanamivira u serumu.
English: 12 mg/kg twice daily up to a maximum dose of 600 mg twice daily
Croatian: 12 mg/kg dvaput na dan, do maksimalne doze od 600 mg dvaput na dan
English: However, there is no information on placental transfer in humans.
Croatian: nema informacija o prolasku kroz posteljicu u ljudi.
English: Zanamivir solution for infusion 600 mg
Croatian: Zanamivir otopina za infuziju 600 mg
English: Zanamivir solution for infusion 300 mg
Croatian: Zanamivir otopina za infuziju 300 mg
English: Skin and subcutaneous tissue disorders rash common urticaria uncommon erythema multiforme Stevens-Johnson syndrome toxic epidermal necrolysis not known
Croatian: Poremećaji kože i potkožnog tkiva osip često urtikarija manje često multiformni eritem Stevens-Johnsonov sindrom toksična epidermalna nekroliza nepoznato
English: Each vial contains 3.08 mmol (70.8 mg) sodium.
Croatian: Pomoćne tvari s poznatim učinkom Jedna bočica sadrži 3,08 mmol (70,8 mg) natrija.
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.
Croatian: Pedijatrijska populacija Profil nuspojava u pedijatrijskoj populaciji temelji se na 71 bolesniku u dobi od ≥ 6 mjeseci do
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).
Croatian: Farmakokinetika zanamivira bila je slična u ispitanika u dobi od 6 mjeseci do < 18 godina (koji su primali standardnu dozu od 12 mg/kg, 14 mg/kg ili 600 mg, u skladu s dobi i tjelesnom težinom) i odraslih ispitanika (koji su primali standardnu dozu od 600 mg) (Tablica 7).
English: Children Your doctor will decide on the correct dose of Dectova.
Croatian: Liječnik će odrediti točnu dozu lijeka Dectova.
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).
Croatian: • Volumen lijeka Dectova i ukupan volumen za infuziju ovisit će o bolesnikovoj dobi, tjelesnoj težini i bubrežnoj funkciji (vidjeti dio 4.2).
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).
Croatian: Supstitucije u neuraminidazi koje smanjuju osjetljivost na zanamivir javile su se tijekom primjene zanamivira za liječenje infekcija humanim virusima i virusima koji imaju zoonotički potencijal: E119D, E119G, I223R, R368G, G370D, N434S
English: Adults The recommended dose is 600 mg twice daily for 5 to 10 days given by intravenous infusion.
Croatian: Preporučena doza je 600 mg dvaput na dan tijekom 5 - 10 dana, a primjenjuje se intravenskom infuzijom.
English: 26 mL clear vial (type I glass) with a stopper (coated chlorobutyl rubber), an over-seal (aluminium) and a plastic flip-off cap.
Croatian: Prozirna bočica (staklo tipa I) volumena 26 ml s čepom (obložena klorbutilna guma), zaštitnim prstenom (aluminij) i plastičnom flip-off kapicom.
English: CLcr or CLCRRT (mL/min/1.73 m
Croatian: CLcr ili CLCRRT (ml/min/1,73 m2)
English: There was no evidence of interaction with oral oseltamivir in a clinical study.
Croatian: U kliničkom ispitivanju nisu pronađeni dokazi interakcije s peroralno primijenjenim oseltamivirom.
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.
Croatian: Primjenom intravenske doze od 600 mg postignute su koncentracije u tekućini koja oblaže bronhalni epitel koje su bile najbliže onima zabilježenima nakon primjene odobrene doze zanamivira u obliku praška inhalata od 10 mg, za koju je u velikim kliničkim ispitivanjima dokazana djelotvornost kod nekomplicirane gripe.
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 of the SmPC).
Croatian: • Volumen lijeka Dectova i ukupan volumen za infuziju ovisit će o bolesnikovoj dobi, tjelesnoj težini i bubrežnoj funkciji (vidjeti dio 4.2 sažetka opisa svojstava lijeka).
English: How Dectova is given
Croatian: Kako se Dectova primjenjuje
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.
Croatian: Nakon primjene zanamivira u obliku otopine za infuziju u dozi od 600 mg dvaput na dan, medijan najnižih koncentracija zanamivira u sekretu bronhalnog epitela kretao se u rasponu od 419 ng/ml do 584 ng/ml te je odgovarao 47 - 66% koncentracija izmjerenih u početnom bronhoalveolarnom uzorku nakon peroralne primjene zanamivira u obliku praška inhalata u dozi od 10 mg dvaput na dan.
English: • levels of zanamivir in broncho-epithelial lining fluid and serum zanamivir from a broncho-alveolar lavage study;
Croatian: • podataka o razinama zanamivira u sekretu koji oblaže bronhalni epitel i serumskim razinama zanamivira iz ispitivanja u kojem se provodila bronhoalveolarna lavaža
English: • The infusion bag should be gently manipulated by hand to ensure it is mixed thoroughly.
Croatian: • Rukama nježno stisnite infuzijsku vrećicu nekoliko puta kako biste bili sigurni da se lijek dobro pomiješao s otopinom.
English: Adults The recommended dose is 600 mg twice daily for 5 to 10 days.
Croatian: Preporučena doza je 600 mg dvaput na dan tijekom 5 - 10 dana.
English: Dectova 10 mg/mL solution for infusion
Croatian: Dectova 10 mg/ml otopina za infuziju
English: 6 months - <1 year mg/kg
Croatian: 6 mjeseci do < 1 godine mg/kg
English: dk-info@gsk.com
Croatian: gskcyprus@gsk.com
English: Solution for infusion 200 mg/20 mL 1 vial
Croatian: Otopina za infuziju 200 mg/20 ml
English: • Decide on the volume of sodium chloride 9 mg/mL (0.9%) solution for injection to be used for infusion.
Croatian: • Odredite volumen otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%) koji će se upotrijebiti za infuziju.
English: Dectova contains sodium
Croatian: Dectova sadrži natrij
English: België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
Croatian: GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien
English: United Kingdom GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Croatian: GlaxoSmithKline UK Ltd Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: It is supplied in a 26 mL clear glass vial with a rubber stopper and an aluminium over-seal with a plastic flip off cap.
Croatian: Dolazi u prozirnoj staklenoj bočici volumena 26 ml s gumenim čepom, aluminijskim zaštitnim prstenom i plastičnom flip-off kapicom.
English: Immune system disorders oropharyngeal oedema facial oedema anaphylactic/anaphylactoid reactions not known
Croatian: Poremećaji imunološkog sustava orofaringealni edem edem lica anafilaktičke/anafilaktoidne reakcije nepoznato
English: Adults and children (aged 6 years and over with a body weight of 50 kg or above) with creatinine clearance (CLcr) or clearance by continual renal replacement therapy (CLCRRT) < 80 mL/min should receive an initial 600 mg dose followed by twice-daily maintenance dosing according to their renal function (Table 2).
Croatian: Odrasli i djeca (u dobi od 6 ili više godina i tjelesne težine od 50 kg ili više) kojima klirens kreatinina (engl. creatinine clearance, CLcr) ili klirens kontinuiranom bubrežnom nadomjesnom terapijom (engl. clearance by continual renal replacement therapy, CLCRRT) iznosi < 80 ml/min trebaju primiti početnu dozu od 600 mg, a zatim dvaput na dan dozu održavanja određenu u skladu s njihovom bubrežnom funkcijom (Tablica 2).
English: Uncommon side effects These may affect up to 1 in 100 people
Croatian: Mogu se javiti u do 1 na 100 osoba
English: • Using a sterile needle and syringe, withdraw the volume of Dectova from the vial(s) and add to the infusion bag.
Croatian: • Koristeći sterilnu iglu i štrcaljku, izvucite odgovarajući volumen lijeka Dectova iz bočice/bočica i dodajte ga u infuzijsku vrećicu.
English: CLcr or CLCRRT (mL/min or mL/min/1.73m
Croatian: CLcr ili CLCRRT (ml/min ili ml/min/1,73 m2)*
English: Zanamivir is cleared by renal excretion and is expected to be removed by haemodialysis.
Croatian: Zanamivir se izlučuje putem bubrega, pa se očekuje da se može ukloniti hemodijalizom.
English: Adults and children aged 6 months or more can be treated with Dectova.
Croatian: Lijekom Dectova mogu se liječiti odrasli i djeca u dobi od 6 mjeseci ili više.
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).
Croatian: o proširen osip praćen mjehurićima i ljuštenjem kože, osobito oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom) o opsežno ljuštenje kože na velikom dijelu tjelesne površine (toksična epidermalna nekroliza)
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.
Croatian: • Doza se može infundirati u obliku u kojem dolazi ili razrijediti u otopini natrijeva klorida za injekciju od 9 mg/ml (0,9%) do bilo koje koncentracije od ≥ 0,2 mg/ml.