FrancophonIA/ELRC3.0 huggingface dataset:
English: The diluted solution for infusion should be administered to patients using a low-protein binding infusion bag and set (a non di (2-ethylhexyl) phthalate [DEHP] bag could be used) and the application of an infusion set equipped with an in-line, low-protein binding 0.2 μm filter is recommended.
Croatian: Razrijeđenu otopinu za infuziju treba primijeniti bolesniku pomoću infuzijske vrećice i seta s niskim afinitetom vezanja proteina (može se primijeniti vrećica koja nije od di(2-etilheksil)ftalata [DEHP]), te se preporučuje primjena seta za infuziju koji je opremljen linijskim filtrom od pora veličine 0,2 μm s niskim afinitetom vezanja proteina.
English: It is recommended that premedication with non-sedating antihistamines with or without antipyretics be administered 30-60 minutes prior to the start of the infusion (see section 4.2).
Croatian: Preporučuje se primjena nesedativnih antihistaminika s antipiretikom ili bez njega 30 do 60 minuta prije početka infuzije (vidjeti dio 4.2).
English: Management of hypersensitivity reactions should be based on the severity of the reaction and include temporary interruption or discontinuation of the infusion and/or administration of additional antihistamines, antipyretics, and/or corticosteroids for mild to moderate reactions.
Croatian: Liječenje reakcija preosjetljivosti potrebno je temeljiti na težini reakcije i uključiti privremeni ili trajni prekid infuzije i/ili primijeniti dodatne antihistaminike, antipiretike i/ili kortikosteroide za blage do umjerene reakcije.
English: Gently rock the infusion bag to ensure proper distribution of Mepsevii.
Croatian: Lagano naginjite infuzijsku vrećicu s jedne na drugu stranu kako biste osigurali prikladnu distribuciju lijeka Mepsevii.
English: Table 1 lists the adverse reactions reported from 4 clinical trials in 23 patients treated with Mepsevii.
Croatian: Tablici 1 navedene su nuspojave prijavljene u 4 klinička ispitivanja u 23 bolesnika liječena lijekom Mepsevii.
English: MPS VII is an illness that runs in families, where the body does not produce enough of an enzyme called beta-glucuronidase.
Croatian: MPS VII je nasljedna bolest u kojoj organizam ne proizvodi dovoljno enzima pod nazivom betaglukuronidaza.
English: This event was assessed as possibly related to vestronidase alfa due to the temporal association with the infusion.
Croatian: Za taj je događaj povezanost s vestronidazom alfa ocijenjena kao moguća, zbog vremenske povezanosti s infuzijom.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Mepsevii Lijek čuvajte izvan pogleda i dohvata djece.
English: Mepsevii is not likely to affect you being able to drive or use machines.
Croatian: Malo je vjerojatno da će Mepsevii utjecati na Vašu sposobnost upravljanja vozilima ili strojevima.
English: Each vial dosed is therefore equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: Doza od jedne bočice stoga odgovara količini od 1,8 % preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: The key secondary endpoint was the multi-domain clinical responder index (MDRI) score consisting of six domains [six-minute walk test (6MWT), forced vital capacity (FVC), shoulder flexion, visual acuity, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) fine motor and gross motor function] after 24 weeks of treatment and fatigue total score as measured by the Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL).
Croatian: Ključna sekundarna mjera ishoda bio je rezultat indeksa kliničkog odgovora u više domena (engl. multi-domain clinical responder index, MDRI) koji se sastoji od 6 domena [šestominutni test hodanja (engl. six-minute walk test, 6MWT), forsirani vitalni kapacitet (engl. forced vital capacity, FVC), fleksija ramena, vidna oštrina, Bruininks-Oseretsky test motorne spretnosti (BOT-2) fine motorike i grube motorne funkcije] nakon 24 tjedna liječenja te ukupni rezultat umora izmjeren multidimenzionalnom skalom umora Upitnika o kvaliteti života u pedijatrijskih bolesnika (engl.
English: After 24 weeks of treatment with vestronidase alfa, a rapid and sustained, highly significant reduction in uGAG (DS) excretion was achieved with a LS mean (±SE) percentage change of -64.82% (±2.468%) (p<0.0001).
Croatian: Nakon 24 tjedna liječenja vestronidazom alfa postignuto je brzo i održivo, jako značajno smanjenje izlučivanja uGAG-a (DS) sa srednjom vrijednosti promjene u postotcima dobivene metodom najmanjih kvadrata (±SE) od -64,82 % (±2,468 %) (p < 0,0001).
English: Do not heat, microwave or shake vials.
Croatian: Bočice nemojte zagrijavati, grijati u mikrovalnoj ili tresti.
English: Life-threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Croatian: Preosjetljivost opasna po život (anafilaktička reakcija) na djelatnu tvar ili na druge pomoćne tvari navedene u dijelu 6.1 (vidjeti dio 4.4).
English: The lowest rate administered to a patient in the clinical development program was 0.5 mL/hour during the first 30 minutes of infusion, followed by 1 mL/hour over the next 30 minutes, equalling 0.75 mL as the lowest total volume infused during the first hour.
Croatian: Najmanja brzina primijenjena bolesniku u kliničkom razvojnom programu bila je 0,5 ml/sat tijekom prvih 30 minuta infuzije, nakon čega je slijedila brzina od 1 ml/sat tijekom sljedećih
English: There is no experience with overdoses of vestronidase alfa.
Croatian: Nema iskustava s predoziranjem vestronidazom alfa.
English: Do not shake the solution.
Croatian: Otopinu nemojte tresti.
English: Common *Refer to description of selected adverse reactions for details on the febrile convulsion reported in 1 of 23 trial patients.
Croatian: *Pogledajte opis odabranih nuspojava radi pojedinosti o febrilnim konvulzijama prijavljenima kod 1 od 23 bolesnika u ispitivanjima.
English: The safety and efficacy of vestronidase alfa in patients with renal or hepatic impairment have not been evaluated.
Croatian: Sigurnost i djelotvornost vestronidaze alfa u bolesnika s oštećenjem bubrega ili jetre nisu još procijenjene.
English: - The active substance is vestronidase alfa.
Croatian: - Djelatna tvar je vestronidaza alfa.
English: The patient subsequently was re-challenged without recurrence and continued on vestronidase alfa treatment.
Croatian: Bolesnik je naknadno ponovno primio lijek i nije bilo povratka nuspojave te je liječenje vestronidazom alfa nastavljeno.
English: The presence of ADA (non-NAb and NAb) does not appear to affect reduction in the pharmacodynamic marker, urinary glycosaminoglycans (uGAGs).
Croatian: Čini se kako prisutnost protutijela ADA (neneutralizirajućih i neutralizirajućih) ne utječe na smanjenje farmakodinamičkog markera, urinarnih glikozaminoglikana (uGAGs).
English: To minimise the risk of hypersensitivity reactions, a non-sedating antihistamine with or without an antipyretic medicinal product should be administered 30-60 minutes prior to the start of the infusion (see section 4.4).
Croatian: Kako biste minimizirali rizik od reakcija preosjetljivosti, primijenite nesedativni antihistaminik s antipiretikom ili bez njega 30 do 60 minuta prije početka infuzije (vidjeti dio 4.4).
English: The limited pharmacokinetic data at steady state suggest dose proportional increase in exposure of vestronidase alfa over the dose range of 1 - 4 mg/kg every other week.
Croatian: Ograničeni podaci o farmakokinetici u stanju dinamičke ravnoteže ukazuju na dozi proporcionalno povećanje u izloženosti vestronidazi alfa u rasponu doza od 1 mg/kg do 4 mg/kg svaki drugi tjedan.
English: a. Volume (mL) of calculated dose = Total dose (mg) divided by the 2 mg/mL concentration
Croatian: Volumen (ml) izračunate doze = ukupna doza (mg) podijeljena s 2 mg/ml koncentracije
English: Minimal important differences (MIDs) were pre-specified for the six MDRI domains plus fatigue, which are: 6MWT (≥23 meters and ≥10% change from baseline), FVC (5% absolute change or 10% relative change from baseline in FVC%pred), shoulder flexion (20 degree change of both shoulder range of motion), visual acuity (3 lines (corrected, both eyes), BOT-2 fine motor (fine motor precision: change of 0.72, and manual dexterity: change of 1.47), BOT-2 gross motor (balance: 0.57, and running speed and agility: 0.59), and fatigue (10 points of total score).
Croatian: Minimal important difference, MID) bile su prethodno određene za šest domena MDRI plus umor, odnosno: 6MWT (≥ 23 metara i promjena za ≥ od 10 % od početne razine), FVC (apsolutna promjena od 5 % ili relativna promjena za 10 % od početne razine u FVC%pred), fleksija ramena (promjena od 20 stupnjeva za raspon pokreta u oba ramena), oštrina vida (3 retka (ispravljena, oba oka), BOT-2 fina motorika (preciznost fine motorike: promjena od 0,72, i spretnost ruku: promjena od 1,47), BOT-2 gruba motorika (ravnoteža: 0,57 te brzina trčanja i spretnost: 0,59) te umor (10 bodova ukupne skale).
English: Two other patients with baseline hepatosplenomegaly had reduction in liver volume (24% and 53%) and spleen volume (28% and 47%) after 36 weeks of treatment.
Croatian: Druga dva bolesnika koja su na početku liječenja imala hepatosplenomegaliju pokazali su smanjenje volumena jetre (24 % i 53 %) i volumena slezene (28 % i
English: One patient receiving a vestronidase alfa dose of 4 mg/kg experienced a febrile convulsion during treatment at the week 66, within 3 days of diphtheria, tetanus, pertussis vaccination.
Croatian: Jedan bolesnik koji je primio vestronidazu alfa u dozi od 4 mg/kg imao je febrilne konvulzije tijekom liječenja u 66. tjednu unutar 3 dana od primitka cjepiva protiv difterije, tetanusa i hripavca.
English: This medicine replaces beta-glucuronidase - this helps to break down the sugars that collect in the tissues of people with MPS VII.
Croatian: Ovaj lijek nadomješta beta-glukuronidazu - to pomaže u razgradnji šećera koji se nakupljaju u tkivu osoba s mukopolisaharidozom VII.
English: Side effects were mainly seen while patients were being given the medicine or within a day after the infusion (infusion reactions).
Croatian: Nuspojave su većinom opažene tijekom primjene lijeka bolesnicima ili unutar jednog dana od infuzije
English: Patient Weight Range (kg)
Croatian: Raspon tjelesne težine bolesnika (kg)
English: Intravenous use after dilution.
Croatian: Za intravensku primjenu nakon razrjeđivanja.
English: Mepsevii contains sodium
Croatian: Mepsevii sadrži natrij
English: - Store in a refrigerator (2°C to 8°C).
Croatian: Neotvorene bočice: - Čuvati u hladnjaku (2°C do 8°C).
English: No human data are available on the effect of vestronidase alfa on fertility.
Croatian: Nisu dostupni podaci o učinku vestronidaze alfa na plodnost u ljudi.
English: Determine the number of vials to be diluted based on the patient's actual weight and the recommended dose of 4 mg/kg, using the following calculations (a-b):
Croatian: Utvrdite broj bočica koje je potrebno razrijediti na temelju stvarne tjelesne težine bolesnika i preporučene doze od 4 mg/kg pomoću formule navedene u nastavku (a,b):
English: It is supplied in a clear glass vial with a rubber stopper and an aluminium seal with a plastic cap.
Croatian: Isporučuje se u prozirnoj, staklenoj bočici s gumenim čepom i aluminijskim prstenom s plastičnim poklopcem.
English: Total Mepsevii Dose Range (mg)
Croatian: Ukupni raspon doze lijeka Mepsevii (mg)
English: Each vial of Mepsevii is intended for single use only.
Croatian: Bočica lijeka Mepsevii namijenjena je samo za jednokratnu primjenu.
English: How Mepsevii works
Croatian: Kako djeluje Mepsevii
English: Consider rapid sodium chloride 9 mg/mL (0.9%) solution for infusion for decreased blood pressure and oxygen for hypoxia.
Croatian: Razmotrite brzu primjenu otopine natrijevog klorida od 9 mg/ml (0,9 %) za infuziju kod sniženog krvnog tlaka i kisika za hipoksiju.
English: Pack size: 1 vial containing 5 mL of concentrate for solution for infusion.
Croatian: Veličina pakiranja: 1 bočica sadrži 5 ml koncentrata za otopinu za infuziju.
English: It is used in adults and children of all ages with MPS VII to treat nonneurological manifestations of the disease (mucopolysaccharidosis VII, also known as Sly Syndrome).
Croatian: Primjenjuje se kod mukopolisaharidoze VII (MPS VII) u odraslih i djece bilo koje dobi za liječenje manifestacija bolesti koje nisu neurološke naravi (mukopolisaharidoza VII, poznata i kao Sly sindrom).
English: Sodium dihydrogen phosphate dihydrate Sodium chloride
Croatian: natrijev dihidrogenfosfat dihidrat natrijev klorid histidin polisorbat 20 voda za injekcije
English: Vestronidase alfa is not expected to be eliminated through renal or faecal excretion.
Croatian: Ne očekuje se za vestronidazu alfa eliminacija izlučivanjem putem bubrega ili fecesa.
English: Vestronidase alfa is a recombinant form of human GUS and is intended to provide exogenous GUS enzyme for uptake into cellular lysosomes and subsequent catabolism of accumulated GAGs in affected tissues.
Croatian: Vestronidaza alfa rekombinantni je oblik humanog GUS-a čiji je cilj da omogući unos egzogenog enzima GUS u stanične lizosome i naknadni katabolizam nakupljenog GAG-a u zahvaćenom tkivu.
English: Discuss with your doctor if the benefits of using Mepsevii are greater than the potential risk to your baby while breast-feeding.
Croatian: Sa svojim liječnikom razgovarajte jesu li koristi primjene lijeka Mepsevii veće od mogućih rizika za vaše dijete tijekom dojenja.
English: After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation the total volume of distribution (Vss) was 0.26 ± 0.13 L/kg (range: 0.10 to 0.60 L/kg).
Croatian: Nakon ponovljenog doziranja od 4 mg/kg svaki drugi tjedan u bolesnika s MPS VII, srednja vrijednost ± standardna devijacija ukupnog volumena distribucije (Vss) bila je 0,26 ± 0,13 l/kg (raspon: 0,10 do 0,60 l/kg).
English: This amount is equivalent to 1.8% of the WHO recommended maximum daily intake for sodium (2 g).
Croatian: Ovaj iznos ekvivalentan je 1,8 % maksimalnog dnevnog unosa natrija (2 g) sukladno preporuci Svjetske zdravstvene organizacije.
English: - You may have side effects while you are being given Mepsevii or for up to a day afterwards.
Croatian: - Dok primate Mepsevii ili dan nakon toga možete osjetiti nuspojave.
English: In a multi-centre, randomized, placebo-controlled, Blind-Start, single-crossover Phase 3 trial (Study UX003-CL301, referred to as Study 301), 12 patients with MPS VII received vestronidase alfa 4 mg/kg every two weeks for 24 to 48 weeks.
Croatian: U multicentričnom, randomiziranom, placebom kontroliranom, jednostrukom ukriženom ispitivanju faze 3 sa zaslijepljenim početkom (Ispitivanje UX003-CL301, dalje u tekstu „Ispitivanje 301“), 12 je bolesnika s mukopolisaharidozom VII primilo 4 mg/kg vestronidaze alfa svaka dva tjedna tijekom razdoblja od 24 do 48 tjedana.
English: Due to the low infusion rate, additional sodium chloride 9 mg/mL (0.9%) solution for infusion may be added through a separate line (piggyback or Y tube) to maintain sufficient intravenous flow.
Croatian: Zbog male brzine infuzije, može se dodati dodatna otopina natrijevog klorida od 9 mg/ml (0,9 %) za infuziju putem zasebne linije (sekundarna, „piggyback“ ili Y cijev) kako biste održali dovoljan intravenski protok.
English: It should be considered that the administration of vestronidase alfa does not affect the irreversible complications (e.g. skeletal deformities).
Croatian: Potrebno je uzeti u obzir da primjena vestronidaze alfa ne utječe na nepopravljive komplikacije (npr. deformacije kostiju).
English: After 24 weeks of vestronidase alfa treatment, the overall MDRI results, both pre-specified and post-hoc (6 MDRI domains plus fatigue domain) analyses, were positive with an increase of +0.5 domains (p=0.0527) and +0.8 domains (p=0.0433) including fatigue, respectively (t-test).
Croatian: obje predspecificirane i post-hoc (6 MDRI domene plus domena umora ) analize, bile su pozitivne uz povećanje od +0,5 domena (p = 0,0527) i +0,8 domena (p = 0,0433) uključujući umor (t-test).
English: In most patients, a pattern of attenuated immunogenicity with chronic exposure was suggested by declining antibody titres over time on continuous treatment.
Croatian: U većine je bolesnika opadajući titar protutijela tijekom kontinuiranog liječenja ukazao na obrazac atenuirane imunogenosti s kroničnom izloženosti.
English: Most adverse reactions were mild to moderate in severity.
Croatian: Nuspojave su većinom bile blage do umjerene težine.
English: The risks and benefits of readministering vestronidase alfa should be considered following a severe hypersensitivity reaction.
Croatian: Razmotrite rizike i koristi od ponovne primjene vestronidaze alfa nakon teške reakcije preosjetljivosti.
English: Total Mepsevii Volume (rounded) (mL)
Croatian: Ukupni volumen lijeka Mepsevii (zaokruženo) (ml)
English: What Mepsevii is and what it is used for 2.
Croatian: Što je Mepsevii i za što se koristi
English: After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation of the total clearance (CL) was 0.079 ± 0.045 L/h/kg (range: 0.038 to 0.20 L/h/kg); the mean ± standard deviation of the elimination half-life (t1/2) was 2.6 ± 0.6 hours (range: 0.9 to 3.6 hours).
Croatian: Nakon ponovljenog doziranja od 4 mg/kg svaki drugi tjedan u bolesnika s MPS VII, srednja vrijednost ± standardna devijacija ukupnog klirensa (CL) bila je 0,079 ± 0,045 l/h/kg (raspon: 0,038 do 0,20 l/h/kg); srednja vrijednost ± standardna devijacija poluvremena eliminacije (t1/2) bila je 2,6 ± 0,6 sati (raspon: 0,9 do 3,6 sati).
English: Slowly withdraw Mepsevii from the appropriate number of vials using caution to avoid excessive agitation and any air or frothing.
Croatian: Polako povucite lijek Mepsevii iz prikladnog broja bočica, izbjegavajući pretjerano protresanje i svako povlačenje zraka ili pjenjenje.
English: Mepsevii must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique according to the steps described below.
Croatian: Lijek Mepsevii mora se razrijediti s 0,9 %-tnom otopinom natrijeva klorida za injekciju (9 mg/ml) s pomoću aseptične tehnike u skladu s koracima navedenim u nastavku.
English: Table 1 Adverse reactions reported in patients treated with Mepsevii MedDRA System Organ Class
Croatian: Tablica 1 Nuspojave prijavljene u bolesnika koji se liječe lijekom Mepsevii
English: There are no data on the use of vetronidase alfa in pregnant women.
Croatian: Nema podataka o primjeni vestronidaze alfa u trudnica.
English: Each vial of 5 mL concentrate contains 10 mg vestronidase alfa (10 mg/ 5 mL).
Croatian: Jedna bočica od 5 ml koncentrata sadrži 10 mg vestronidaze alfa (10 mg/5 ml).
English: MedDRA Preferred Term
Croatian: MedDRA preporučeni pojam Učestalost
English: It should be considered by the treating physician that the administration of vestronidase alfa does not affect the irreversible complications (e.g. skeletal deformities).
Croatian: Nadležni liječnik treba uzeti u obzir da primjena vestronidaze alfa ne utječe na ireverzibilne komplikacije (npr. deformitete koštanog sustava).
English: The assessment of adverse reactions was based on the exposure of 23 patients from 4 clinical trials, aged 5 months to 25 years, who received vestronidase alfa at doses up to 4 mg/kg once every two weeks for up to 132 weeks.
Croatian: Procjena nuspojava temeljila se na izloženosti 23 bolesnika iz 4 klinička ispitivanja, u dobi od 5 mjeseci do 25 godina, koji su primali vestronidazu alfa u dozama do 4 mg/kg jednom svaka dva tjedna do 132 tjedna.
English: This medicine contains 17.8 mg sodium (main component of cooking/table salt) in each 5-mL vial, and is administered with sodium chloride 9 mg/mL as a diluent.
Croatian: Ovaj lijek sadrži 17,8 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici od 5 ml te se primjenjuje razrijeđen u otopini natrijevog klorida od 9 mg/ml.
English: In addition, uGAG response (% change from study week 0) shows a similar magnitude of reduction in uGAG in all groups after crossover to active treatment.
Croatian: pokazuje sličnu veličinu smanjenja uGAG-a u svim skupinama nakon prijelaza na aktivno liječenje.
English: Colourless to slightly yellow solution.
Croatian: Bezbojna do žućkasta otopina.
English: Sodium restricted diet
Croatian: Prehrana s ograničenim unosom natrija
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Njemačka Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: A sufficiently large needle (18 gauge) should be used to minimise bubbles in the solution.
Croatian: Upotrebljavajte dovoljno veliku iglu (18 G)
English: Patients who were enrolled in Study 301 were eligible to roll over to Study UX003-CL202 (referred to as Study 202), an open-label extension trial in which patients received additional doses of vestronidase alfa at 4 mg/kg intravenously every other week for up to 144 weeks.
Croatian: Bolesnici koji su bili uključeni u Ispitivanje 301 bili su podobni za prijelaz u Ispitivanje UX003-CL202 (dalje u tekstu „Ispitivanje 202“), otvoreni produžetak ispitivanja u kojem su bolesnici primali dodatne doze vestronidaze alfa u dozi od 4 mg/kg intravenski svaki drugi tjedan do 144 tjedna.
English: Dilute the calculated dose 1:1 using equal volume of sodium chloride 9 mg/mL (0.9%) solution for injection for intravenous infusion.
Croatian: Razrijedite izračunatu dozu 1:1 pomoću jednakog volumena 0,9 %-tne otopine natrijeva klorida za injekciju (9 mg/ml) za intravensku infuziju.
English: For the management of adverse reactions, see sections 4.4 and 4.8.
Croatian: Za zbrinjavanje nuspojava, vidjeti dijelove 4.4 i
English: Mepsevii 2 mg/mL concentrate for solution for infusion.
Croatian: Mepsevii 2 mg/ml koncentrat za otopinu za infuziju.
English: Spinal or cervical cord compression is a known and serious complication of MPS VII.
Croatian: Kompresija kralježnične moždine /vratnog dijela kralježnične moždine Kompresija kralježnične moždine /vratnog dijela kralježnične moždine poznata je i ozbiljna komplikacija MPS VII.
English: Study UX003-CL201 (referred to as Study 201) was a single arm, open-label, dose exploration trial that enrolled three MPS VII patients, ranging in age from 5 years to 25 years.
Croatian: Ispitivanje UX003-CL201 (dalje u tekstu „Ispitivanje 201“) bilo je otvoreno ispitivanje doze u jednoj skupini u koje su bila uključena tri bolesnika s MPS VII u dobi od 5 do 25 godina.
English: Mepsevii contains an enzyme called vestronidase alfa.
Croatian: Mepsevii sadrži enzim vestronidazu alfa.
English: Pack size: 1 vial of 5 mL
Croatian: Veličina pakiranja: Jedna bočica od 5 ml
English: Recommended infusion rate schedule by patient weight for administration of Mepsevii at recommended dose of 4 mg/kg Patient Weight Range (kg)
Croatian: Tablica 2. Preporučeni raspored brzine infuzije prema tjelesnoj težini bolesnika radi primjene lijeka Mepsevii u preporučenoj dozi od 4 mg/kg
English: After repeated dosing of 4 mg/kg every other week, the maximal serum concentration (Cmax) was 20.0 ± 8.1 µg/mL (mean ± s.d.; range: 6.6 to 34.9 µg/mL) and the area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) was 57.4 ± 23.9 µg*h/mL (mean ± s.d.; range: 18.8 to 97.0 µg*h/mL).
Croatian: (srednja vrijednost ± s.d.; raspon: 6,6 do 34,9 µg/ml); a područje ispod krivulje koncentracije u odnosu na vrijeme od nulte vremenske točke do zadnje mjerljive koncentracije (AUC0-t) bila je 57,4 ± 23,9 µg*h/ml (srednja vrijednost ± s.d.; raspon: 18,8 do 97,0 µg*h/ml).
English: Round to the next whole vial and remove the required number of vials (refer to Table 2) from the refrigerator to allow them to reach room temperature up to a maximum of 25°C.
Croatian: b. ukupni broj bočica = ukupna doza (mg) podijeljeno s 10 mg/bočici 2. Zaokružite do sljedeće cijele bočice i izvadite potrebni broj bočica (vidjeti Tablicu 2) iz hladnjaka kako bi dosegnule sobnu temperaturu do maksimalno 25°C.