FrancophonIA/ELRC3.0 huggingface dataset:
English: A randomised, double-blind study examined the incidence of drug hypersensitivity reactions in healthy volunteers given up to 3 doses of placebo (N=76), sugammadex 4 mg/kg (N=151) or sugammadex 16 mg/kg (N=148).
Croatian: Randomiziranim, dvostruko slijepim ispitivanjem ispitala se incidencija reakcija preosjetljivosti na lijek u zdravih dobrovoljaca koji su primili do 3 doze placeba (N=76), sugamadeksa u dozi od 4 mg/kg (N=151) ili sugamadeksa u dozi od 16 mg/kg (N=148).
English: • Airway difficulties that may include coughing or moving as if you are waking or taking a breath
Croatian: • poteškoće s dišnim putevima koje mogu uključivati kašljanje ili pokrete poput onih tijekom buđenja ili prilikom udisanja
English: In rare instances, marked bradycardia has been observed within minutes after the administration of sugammadex for reversal of neuromuscular blockade.
Croatian: U rijetkim slučajevima, opažena je značajna bradikardija unutar nekoliko minuta nakon primjene sugamadeksa za reverziju neuromuskularne blokade.
English: In post-marketing, isolated cases of marked bradycardia and bradycardia with cardiac arrest have been observed within minutes after administration of sugammadex (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet opaženi su izolirani slučajevi značajne bradikardije i bradikardije sa srčanim zastojem unutar nekoliko minuta nakon primjene sugamadeksa (vidjeti dio 4.4).
English: The use of lower than recommended doses may lead to an increased risk of recurrence of neuromuscular blockade after initial reversal and is not recommended (see section 4.2 and section 4.8).
Croatian: Ne preporuča se primjena doza nižih od preporučene jer može dovesti do povećanog rizika od ponovne pojave neuromuskularne blokade nakon inicijalne reverzije (vidjeti dijelove 4.2 i 4.8).
English: Sugammadex is rapidly cleared in preclinical species, although residual sugammadex was observed in bone and teeth of juvenile rats.
Croatian: Sugamadeks se brzo uklanja u laboratorijskih životinja, iako je u kostima i zubima mladih štakora primjećen rezidualni sugamadeks.
English: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections
Croatian: 3,7%-tna kloridna kiselina (za podešavanje pH) i/ili natrijev hidroksid (za podešavanje pH) voda za injekcije
English: After first opening and dilution, store at 2 to 8°C and use within 24 hours.
Croatian: Nakon prvog otvaranja i razrjeđivanja, čuvati na temperaturi od 2°C do 8°C i primijeniti u roku od 24 sata.
English: Total exposure to sugammadex was prolonged, leading to 17-fold higher exposure in patients with severe renal impairment.
Croatian: Ukupna izloženost sugamadeksu bila je dulja, što je dovelo do 17 puta veće izloženosti u bolesnika s teškim oštećenjem funkcije bubrega.
English: Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL.
Croatian: Veličine pakiranja: 10 bočica od 2 ml ili 10 bočica od 5 ml.
English: Low concentrations of sugammadex are detectable for at least 48 hours post-dose in patients with severe renal insufficiency.
Croatian: Niske koncentracije sugamadeksa se mogu otkriti tijekom najmanje 48 sati nakon primjene doze u bolesnika s teškim oštećenjem funkcije bubrega.
English: In these studies a clear dose-response relationship was observed.
Croatian: U tim je ispitivanjima opažena jasna korelacija između veličine doze i terapijskog odgovora.
English: 2 mL or 5 mL of solution in type I glass vial closed with chlorobutyl rubber stoppers with aluminium crimp-cap and flip-off seal.
Croatian: 2 ml ili 5 ml otopine u staklenoj bočici (staklo tipa I) zatvorenoj čepom od klorbutilne gume i aluminijskim prstenom sa zaštitnim zatvaračem.
English: In the exceptional situation of recurrence of neuromuscular blockade post-operatively (see section 4.4) after an initial dose of 2 mg/kg or 4 mg/kg sugammadex, a repeat dose of 4 mg/kg sugammadex is recommended.
Croatian: U iznimnim situacijama kada se poslijeoperacijski ponovno pojavi neuromuskularna blokada (vidjeti dio 4.4) nakon početne doze sugamadeksa od 2 mg/kg ili 4 mg/kg, preporučuje se ponoviti dozu sugamadeksa od 4 mg/kg.
English: For paediatric patients Bridion can be diluted using sodium chloride 9 mg/mL (0.9%) to a concentration of 10 mg/mL (see section 6.3).
Croatian: Za primjenu u pedijatrijskih bolesnika, Bridion se može razrijediti pomoću otopine natrijevog klorida od 9 mg/ml (0,9%) do koncentracije od 10 mg/ml (vidjeti dio 6.3).
English: - The other ingredients are water for injections, hydrochloric acid 3.7% and/or sodium hydroxide.
Croatian: Drugi sastojci su voda za injekcije, 3,7%-tna kloridna kiselina i/ili natrijev hidroksid.
English: Excretion via faeces or expired air was less than 0.02% of the dose.
Croatian: Manje od 0,02% doze izlučilo se fecesom ili izdahnutim zrakom.
English: There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade.
Croatian: Nema podataka na temelju kojih bi se mogla preporučiti primjena sugamadeksa za trenutnu reverziju blokade izazvane vekuronijem.
English: If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended.
Croatian: U slučaju da je iz kliničkih razloga potrebno provesti trenutnu reverziju nakon primjene rokuronija, preporučuje se doza od 16 mg/kg sugamadeksa.
English: • how much the muscle relaxant medicine is still affecting you.
Croatian: • koliko jako još djeluje lijek koji je mišićni relaksans.
English: These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide.
Croatian: Ti se lijekovi zovu mišićni relaksansi, a neki od njih su rokuronijev bromid i vekuronijev bromid.
English: Intravenous administration of fusidic acid:
Croatian: Intravenski primijenjena fusidatna kiselina:
English: For mild and moderate renal impairment (creatinine clearance ≥ 30 and < 80 mL/min): the dose recommendations are the same as for adults without renal impairment.
Croatian: Kod blagog i umjerenog oštećenja funkcije bubrega (klirens kreatinina ≥ 30 i < 80 ml/min) preporučuju se iste doze kao i za odrasle bolesnike koji nemaju oštećenje funkcije bubrega.
English: In a human tolerance study sugammadex was administered in doses up to 96 mg/kg.
Croatian: U ispitivanju podnošljivosti u ljudi, sugamadeks se primjenjivao u dozama do 96 mg/kg.
English: Sugammadex can be removed using haemodialysis with a high flux filter, but not with a low flux filter.
Croatian: Sugamadeks se može ukloniti hemodijalizom s visokoprotočnom, ali ne i niskoprotočnom membranom.
English: Bridion is considered to be a Selective Relaxant Binding Agent since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.
Croatian: Bridion se smatra lijekom koji se selektivno veže za mišićne relaksanse jer djeluje samo na određene mišićne relaksanse: rokuronijev bromid ili vekuronijev bromid.
English: 1.2 mg/kg rocuronium
Croatian: 1,2 mg/kg rokuronija
English: If a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2 mg/kg.
Croatian: Ako je neophodan kraći vremenski razmak, za novu neuromuskularnu blokadu treba primijeniti dozu rokuronija od 1,2 mg/kg.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon razrjeđivanja lijeka vidjeti u dijelu 6.3.
English: Effect on haemostasis:
Croatian: Utjecaj na hemostazu:
English: A summary of sugammadex pharmacokinetic parameters stratified by age and renal function is presented below:
Croatian: Pregled farmakokinetičkih parametara sugamadeksa stratificiranih prema dobi i funkciji bubrega prikazan je niže:
English: Please refer to the package leaflet of rocuronium or vecuronium for a list of the specific medicinal products which potentiate neuromuscular blockade.
Croatian: Molimo pročitajte Upute o lijeku za rokuronij ili vekuronij, u kojima je naveden popis lijekova koji pojačavaju neuromuskularnu blokadu.
English: Discard any unused solution.
Croatian: Zbrinite neiskorištenu otopinu.
English: For sugammadex no clinical data on exposed pregnancies are available.
Croatian: Nema kliničkih podataka za sugamadeks u trudnica koje su bile izložene lijeku.
English: There were no reports of anaphylaxis after placebo or sugammadex 4 mg/kg.
Croatian: Nije bilo prijava anafilaksije nakon placeba ili sugamadeksa u dozi od 4 mg/kg.
English: It does this by combining with the rocuronium bromide or vecuronium bromide in your body.
Croatian: Čini to tako što se u tijelu veže za rokuronijev bromid ili vekuronijev bromid.
English: Anaesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anaesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube.
Croatian: Anesteziološke komplikacije, koje ukazuju na oporavak neuromuskularne funkcije, uključuju pomicanje udova ili tijela ili kašljanje tijekom postupka anestezije ili same operacije, grimase ili pokrete sisanja endotrahealne cijevi.
English: Even if recovery from neuromuscular blockade is complete, other medicinal products used in the peri- and postoperative period could depress respiratory function and therefore ventilatory support might still be required.
Croatian: Čak i kad se neuromuskularna funkcija potpuno povrati nakon blokade, postoji mogućnost depresije respiracijske funkcije izazvane drugim lijekovima koji se koriste prije, tijekom i poslije operacije pa bi i dalje mogla postojati potreba za mehaničkom ventilacijom.
English: • if you have kidney disease or had in the past.
Croatian: • ako imate ili ste ranije imali bolest bubrega.
English: For toremifene and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
Croatian: Za toremifen i fusidatnu kiselinu ne mogu se isključiti interakcije zbog istiskivanja iz veze s lijekom (no, ne očekuju se klinički značajne interakcije zbog vezanja drugih lijekova).
English: If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used.
Croatian: Ako je neophodna neuromuskularna blokada prije isteka preporučenog vremenskog razmaka, mora se primijeniti nesteroidni neuromuskularni blokator.
English: The onset of a depolarizing neuromuscular blocking agent might be slower than expected, because a substantial fraction of postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent.
Croatian: Nastup djelovanja depolarizirajućeg neuromuskularnog blokatora možda će biti sporiji od očekivanog, jer će na značajan udio nikotinskih receptora na mišićnoj strani neuromuskularne spojnice još uvijek biti vezan neuromuskularni blokator.
English: In general sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay.
Croatian: Sugamadeks općenito ne utječe na rezultate laboratorijskih pretraga, osim možda na mjerenje razine progesterona u serumu.
English: Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular blockade.
Croatian: U bolesnika se obavezno mora primijeniti mehanička ventilacija, sve do odgovarajućeg oporavka spontanog disanja nakon reverzije neuromuskularne blokade.
English: The effects with sugammadex on human fertility have not been investigated.
Croatian: Nisu ispitivani učinci sugamadeksa na plodnost ljudi.
English: Administration of the medicinal product which caused displacement should be stopped in case of an infusion.
Croatian: Mora se prekinuti primjena lijeka koji je prouzročio istiskivanje, ako se davao infuzijom.
English: Two open label studies compared the efficacy and safety of sugammadex in surgical patients with and without severe renal impairment.
Croatian: U dva otvorena ispitivanja uspoređena je djelotvornost i sigurnost primjene sugamadeksa u kirurških bolesnika s teškim oštećenjem funkcije bubrega i onih bez takvog oštećenja.
English: The use of fusidic acid in the pre-operative phase may give some delay in the recovery of the T4/T1 ratio to 0.9.
Croatian: Primjena fusidatne kiseline u razdoblju prije operacije može donekle produljiti vrijeme povrata omjera T4/T1 na vrijednost 0,9.
English: How to store Bridion
Croatian: Kako čuvati Bridion
English: Animal studies have shown excretion of sugammadex in breast milk.
Croatian: Istraživanja na životinjama pokazala su da se sugamadeks izlučuje u mlijeko.
English: For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).
Croatian: Za hormonske kontraceptive se ne može se isključiti klinički značajna interakcija zbog vezanja drugih lijekova (no, ne očekuju se interakcije zbog istiskivanja iz veze s lijekom).
English: Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent.
Croatian: Sugamadeks je modificirani gama ciklodekstrin, koji se selektivno veže za mišićne relaksanse.
English: Sugammadex can be administered at several time points after administration of rocuronium or vecuronium bromide:
Croatian: Sugamadeks se može primijeniti u nekoliko vremenskih točaka nakon primjene rokuronijevog bromida ili vekuronijevog bromida:
English: Adverse reactions (Preferred terms)
Croatian: Nuspojave (preporučeni pojmovi)
English: Based on the clinical data-base (N=3,519) and on a specific study in 1184 patients undergoing hip fracture/major joint replacement surgery there was no clinically relevant effect of sugammadex 4 mg/kg alone or in combination with anticoagulants on the incidence of peri- or post-operative bleeding complications.
Croatian: Na temelju kliničke baze podataka (N=3519) te posebne studije provedene u 1184 bolesnika koji su podvrgnuti operacijskom zahvatu zamjene zbog prijeloma kuka/drugih većih zglobova, sugamadeks primijenjen u dozi od 4 mg/kg samostalno ili u kombinaciji s antikoagulansima nije imao klinički značajan učinak na incidenciju komplikacija krvarenja prije, tijekom i poslije operacije.
English: When 16 mg/kg sugammadex is administered 3 minutes after a bolus dose of 1.2 mg/kg rocuronium bromide, a median time to recovery of the T4/T1 ratio to 0.9 of approximately 1.5 minutes can be expected (see section 5.1).
Croatian: Kad se doza od 16 mg/kg sugamadeksa primijeni 3 minute nakon bolusa rokuronijevog bromida u dozi od 1,2 mg/kg, očekivani medijan vremena za povrat omjera T4/T1 na vrijednost 0,9 iznosi oko 1,5 minutu (vidjeti dio 5.1).
English: → If you are taking the Pill on the same day as Bridion is given to you, follow the instructions for a missed dose in the Pill's package leaflet.
Croatian: → Ako ste primili Bridion na dan kad ste uzeli kontracepcijsku tabletu, slijedite upute za slučaj propuštanja uzimanja tablete, kako je navedeno u Uputi o lijeku za kontracepcijske tablete.
English: Sugammadex should not be used for reversal of neuromuscular blockade induced by steroidal neuromuscular blocking agents other than rocuronium or vecuronium, since there are no efficacy and safety data for these situations.
Croatian: Sugamadeks se ne smije koristiti za reverziju neuromuskularne blokade izazvane drugim steroidnim neuromuskularnim blokatorima, osim rokuronija ili vekuronija, jer nema podataka o djelotvornosti i sigurnosti primjene u takvim situacijama.
English: There was a single case of adjudicated anaphylaxis after the first dose of sugammadex 16 mg/kg (incidence 0.7%).
Croatian: Zabilježen je samo jedan slučaj procijenjene anafilaksije nakon prve doze sugamadeksa od 16 mg/kg (incidencija 0,7%).
English: • If you have further questions, ask your anaesthetist or doctor.
Croatian: • Ako imate dodatnih pitanja, obratite se svom anesteziologu ili liječniku.
English: If sugammadex is administered at the same day as an oral contraceptive is taken reference is made to missed dose advice in the package leaflet of the oral contraceptive.
Croatian: Ako se sugamadeks primijeni istog dana kad se uzeo i oralni kontraceptiv, treba slijediti savjete u uputi o lijeku za oralni kontraceptiv za slučaj da se propustila uzeti dnevna doza.
English: In one study, sugammadex was administered following rocuronium induced blockade at 1-2 PTCs (4 mg/kg; N=68); in the other study, sugammadex was administered at reappearance of T2 (2 mg/kg; N=30).
Croatian: U jednom je ispitivanju sugamadeks primijenjen nakon blokade izazvane rokuronijem pri PTC-u 1-2 (4 mg/kg; N=68), a u drugom nakon ponovne pojave T2 (2 mg/kg; N=30).
English: Sugammadex has been administered in doses ranging from 0.5 mg/kg to 16 mg/kg in dose response studies of rocuronium induced blockade (0.6, 0.9, 1.0 and 1.2 mg/kg rocuronium bromide with and without maintenance doses) and vecuronium induced blockade (0.1 mg/kg vecuronium bromide with or without maintenance doses) at different time points/depths of blockade.
Croatian: U ispitivanjima odgovora na dozu, sugamadeks se primjenjivao u rasponu doza od 0,5 mg/kg do 16 mg/kg nakon blokade izazvane rokuronijem (u obliku rokuronijevog bromida u dozi od 0,6, 0,9, 1,0 i 1,2 mg/kg, sa ili bez primjene doze održavanja), odnosno blokade izazvane vekuronijem (u obliku vekuronijevog bromida, u dozi od 0,1 mg/kg, sa ili bez primjene doze održavanja) u različitim vremenskim točkama/dubinama blokade.
English: In a second study comparing subjects with moderate or severe renal impairment to subjects with normal renal function, sugammadex clearance progressively decreased and t1/2 was progressively prolonged with declining renal function.
Croatian: U drugom ispitivanju, u kojem su uspoređivani ispitanici s umjerenim ili teškim oštećenjem funkcije bubrega s ispitanicima koji imaju normalnu funkciju bubrega, klirens sugamadeksa progresivno se smanjivao, a t1/2 progresivno produljivao sa smanjenjem funkcije bubrega.
English: Other ingredients: hydrochloric acid 3.7% and/or sodium hydroxide (to adjust pH), water for injections.
Croatian: Drugi sastojci: 3,7%-tna kloridna kiselina i/ili natrijev hidroksid (za podešavanje pH), voda za injekcije.
English: It comes in two different pack sizes, containing either 10 vials with 2 mL or 10 vials with 5 mL solution for injection.
Croatian: Postoje dvije veličine pakiranja: 10 bočica od 2 ml ili 10 bočica od 5 ml otopine za injekciju.
English: Airway complications of anaesthesia included bucking against the endotracheal tube, coughing, mild bucking, arousal reaction during surgery, coughing during the anaesthetic procedure or during surgery, or anaesthetic procedure-related spontaneous breath of patient.
Croatian: Komplikacije anestezije na dišnim putevima uključivale su veliki otpor endotrahealnoj cijevi, kašljanje, blagi otpor, reakciju povećane podražljivosti tijekom operacije, kašljanje tijekom anesteziološkog postupka ili tijekom operacije ili spontano disanje bolesnika povezano s anesteziološkim postupkom.
English: Routine reversal - deep neuromuscular blockade:
Croatian: Rutinska reverzija - duboka neuromuskularna blokada:
English: Re-administration of rocuronium or vecuronium after routine reversal (up to 4 mg/kg sugammadex):
Croatian: Ponovna primjena rokuronija ili vekuronija nakon rutinske reverzije (doza do 4 mg/kg sugamadeksa):
English: In the case of non-oral hormonal contraceptives, the patient must use an additional non hormonal contraceptive method for the next 7 days and refer to the advice in the package leaflet of the product.
Croatian: Bolesnica koja ne uzima oralni kontraceptiv, nego neki drugi oblik hormonske kontracepcije, mora koristiti dodatnu nehormonsku kontracepcijsku metodu tijekom sljedećih 7 dana te slijediti savjete u uputi o lijeku za odabranu kontracepcijsku metodu.
English: Drug hypersensitivity reactions:
Croatian: Reakcije preosjetljivosti na lijek:
English: As a result recurrence of neuromuscular blockade might be observed.
Croatian: Posljedica toga može biti ponovna pojava neuromuskularne blokade.
English: What Bridion looks like and contents of the pack Bridion is a clear and colourless to slightly yellow solution for injection.
Croatian: Bridion je bistra i bezbojna do blago žuta otopina za injekciju.
English: In in vitro experiments a pharmacodynamic interaction (aPTT and PT prolongation) was noted with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban and dabigatran.
Croatian: U pokusima in vitro opažena je farmakodinamička interakcija (produljenje aPTV-a i PV-a) s antagonistima vitamina K, nefrakcioniranim heparinom, heparinoidima male molekulske mase, rivaroksabanom i dabigatranom.
English: Procedural hypotension
Croatian: proceduralna hipotenzija proceduralna komplikacija
English: Using the recommended doses for routine reversal will result in a slightly faster median time to recovery of the T4/T1 ratio to 0.9 of rocuronium when compared to vecuronium induced neuromuscular blockade (see section 5.1).
Croatian: Uz primjenu preporučenih doza za rutinsku reverziju blokade, medijan vremena potrebnog da se omjer T4/T1 vrati na vrijednost 0,9 bit će nešto kraći kod neuromuskularne blokade izazvane rokuronijem u usporedbi s blokadom izazvanom vekuronijem (vidjeti dio 5.1).
English: No residual neuromuscular blockade or recurrence of neuromuscular blockade was reported for patients with severe renal impairment in these studies.
Croatian: U tim ispitivanjima nije prijavljena rezidualna neuromuskularna blokada niti povrat neuromuskularne blokade u bolesnika s teškim oštećenjem funkcije bubrega.
English: In in vitro experiments a pharmacodynamic interaction (aPTT and PT prolongation) was noted with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban and dabigatran (see section 4.4).
Croatian: U ispitivanjima in vitro opažena je farmakodinamička interakcija (produljenje aPTV-a i PV-a) s antagonistima vitamina K, nefrakcioniranim heparinom, heparinoidima male molekulske mase, rivaroksabanom i dabigatranom (vidjeti dio 4.4).
English: Bridion contains the active substance sugammadex.
Croatian: Bridion sadrži djelatnu tvar sugamadeks.
English: For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.
Croatian: Pedijatrijska populacija: sugamadeks se u djece i adolescenata u dobi od 2 do 17 godina preporučuje samo za rutinsku reverziju blokade izazvane rokuronijem.
English: The use of sugammadex in patients with severe renal impairment (including patients requiring dialysis (CrCl < 30 mL/min)) is not recommended (see section 4.4).
Croatian: Ne preporučuje se primjena sugamadeksa u bolesnika s teškim oštećenjem funkcije bubrega (uključujući bolesnike na dijalizi (klirens kreatinina < 30 ml/min)) (vidjeti dio 4.4).
English: Sugammadex is not recommended for use in patients with severe renal impairment, including those requiring dialysis (see section 5.1).
Croatian: Ne preporučuje se primjena sugamadeksa u bolesnika s teškim oštećenjem funkcije bubrega, uključujući i bolesnike kojima je potrebna dijaliza (vidjeti dio 5.1).
English: Impaired Mild 26 19 (22)
Croatian: 7 godina oštećena blago 26 19 (22)
English: System organ class
Croatian: Klasifikacija organskih sustava Učestalosti
English: The sugammadex pharmacokinetic parameters were calculated from the total sum of non-complexbound and complex-bound concentrations of sugammadex.
Croatian: Farmakokinetički parametri sugamadeksa izračunati su iz ukupnog zbroja koncentracija slobodnog sugamadeksa i sugamadeksa vezanog u komplekse.
English: In a previous study of similar design, there were three adjudicated cases of anaphylaxis, all after sugammadex 16 mg/kg (incidence 2.0%).
Croatian: U prethodnom ispitivanju sličnog ustroja zabilježena su tri procijenjena slučaja anafilaksije, sva tri nakon primjene sugamadeksa u dozi od 16 mg/kg (incidencija 2,0%).
English: Median time to recovery of the T4/T1 ratio to 0.9 is around 3 minutes (see section 5.1).
Croatian: Medijan vremena potrebnog za povrat omjera T4/T1 na vrijednost 0,9 iznosi oko 3 minute (vidjeti dio 5.1).
English: Median time to recovery of the T4/T1 ratio to 0.9 is around 2 minutes (see section 5.1).
Croatian: Medijan vremena do povrata omjera T4/T1 na vrijednost 0,9 iznosi oko 2 minute (vidjeti dio 5.1).