FrancophonIA/ELRC3.0 huggingface dataset:
English: Immediate reversal of rocuronium-induced blockade:
Croatian: Trenutna reverzija blokade izazvane rokuronijem:
English: Recurrence of neuromuscular blockade:
Croatian: Ponovna pojava neuromuskularne blokade:
English: Caution should be exercised when considering the use of sugammadex in patients with severe hepatic impairment or when hepatic impairment is accompanied by coagulopathy (see section 4.4).
Croatian: Potreban je oprez kada se razmatra primjena sugamadeksa u bolesnika s teškim oštećenjem funkcije jetre ili kada uz oštećenje funkcije jetre postoji i koagulopatija (vidjeti dio 4.4).
English: Sugammadex should be administered intravenously as a single bolus injection.
Croatian: Sugamadeks se primjenjuje intravenski, kao jednokratna bolusna injekcija.
English: It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma and thereby reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction.
Croatian: U plazmi stvara kompleks s neuromuskularnim blokatorom rokuronijem ili vekuronijem te tako smanjuje količinu slobodnog neuromuskularnog blokatora koji se može vezati za nikotinske receptore neuromišićne sinapse.
English: Bridion will be given to you by your anaesthetist, or under the care of your anaesthetist.
Croatian: Bridion će Vam dati anesteziolog ili ćete ga primiti pod nadzorom anesteziologa.
English: Bridion 100 mg/mL solution for injection
Croatian: Bridion 100 mg/ml otopina za injekciju
English: Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.
Croatian: Reverzija neuromuskularne blokade izazvane rokuronijem ili vekuronijem u odraslih.
English: Patients on a controlled sodium diet:
Croatian: Bolesnici na dijeti s ograničenjem unosa natrija:
English: Pharmacokinetic parameters as clearance and volume of distribution are assumed to be the same for non-complex-bound and complex-bound sugammadex in anaesthetised subjects.
Croatian: Smatra se da su farmakokinetički parametri, poput klirensa i volumena distribucije u ispitanika pod anestezijom, isti za slobodni i za sugamadeks vezan u kompleks.
English: In clinical studies with subjects treated with rocuronium or vecuronium, where sugammadex was administered using a dose labelled for the depth of neuromuscular blockade, an incidence of 0.20% was observed for recurrence of neuromuscular blockade as based on neuromuscular monitoring or clinical evidence.
Croatian: U kliničkim ispitivanjima u kojima su ispitanici primili rokuronij ili vekuronij, gdje je sugamadeks primijenjen u dozi propisanoj za dubinu neuromuskularne blokade, opažena je ponovna pojava neuromuskularne blokade uz incidenciju od 0,20% na temelju neuromuskularnog praćenja ili kliničkih dokaza.
English: If these side effects occur while you are under anaesthesia, they will be seen and treated by your anaesthetist.
Croatian: Ako tijekom anestezije nastupe sljedeće nuspojave, anesteziolog će ih primijetiti i zbrinuti.
English: In clinical studies with subjects treated with rocuronium or vecuronium, where sugammadex was administered using a dose labelled for the depth of neuromuscular blockade (N=2,022), an incidence of 0.20% was observed for recurrence of neuromuscular blockade as based on neuromuscular monitoring or clinical evidence (see section 4.4).
Croatian: U kliničkim ispitivanjima u kojima su ispitanici primili rokuronij ili vekuronij, gdje je sugamadeks primijenjen u dozi propisanoj za dubinu neuromuskularne blokade (N=2022), opažena je ponovna pojava neuromuskularne blokade uz incidenciju od 0,20% na temelju neuromuskularnog praćenja ili kliničkih dokaza (vidjeti dio 4.4).
English: What Bridion is used for
Croatian: Za što se Bridion koristi
English: Sugammadex has not been investigated in patients receiving rocuronium or vecuronium in the ICU setting.
Croatian: Sugamadeks nije ispitivan u bolesnika koji su primali rokuronij ili vekuronij u jedinicama intenzivnog liječenja.
English: If you have any further questions on the use of this medicine, ask your anaesthetist or other doctor.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom anesteziologu ili drugom liječniku.
English: The incidence of adjudicated hypersensitivity was 1.3%, 6.6% and 9.5% in the placebo, sugammadex 4 mg/kg and sugammadex 16 mg/kg groups, respectively.
Croatian: Incidencija procijenjene preosjetljivosti iznosila je 1,3% u skupini koja je primala placebo, 6,6% u skupini koja je primala sugamadeks u dozi od 4 mg/kg i 9,5% u skupini koja je primala sugamadeks u dozi od 16 mg/kg.
English: The time to recovery from succinylcholine-induced neuromuscular blockade (1 mg/kg) was compared with sugammadex (16 mg/kg, 3 minutes later) - induced recovery from rocuronium-induced neuromuscular blockade (1.2 mg/kg).
Croatian: Vrijeme do oporavka od neuromuskularne blokade izazvane sukcinilkolinom (1 mg/kg) uspoređeno je s vremenom do oporavka od neuromuskularne blokade izazvane rokuronijem (1,2 mg/kg) nakon primjene sugamadeksa (16 mg/kg, 3 minute kasnije).
English: Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade:
Croatian: Sugamadeks se može koristiti za reverziju različitih stupnjeva neuromuskularne blokade izazvane rokuronijem ili vekuronijem:
English: Routine reversal - moderate neuromuscular blockade:
Croatian: Rutinska reverzija - umjerena neuromuskularna blokada:
English: United Kingdom Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
Croatian: Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
English: Bridion is administered concomitantly with neuromuscular blocking agents and anaesthetics in surgical patients.
Croatian: U kirurških bolesnika Bridion se primjenjuje istodobno s neuromuskularnim blokatorima i anesteticima.
English: This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Croatian: Zbog toga dolazi do reverzije neuromuskularne blokade izazvane rokuronijem ili vekuronijem.
English: Treatment with anti-cholinergic agents such as atropine should be administered if clinically significant bradycardia is observed.
Croatian: Ukoliko se pojavi klinički značajna bradikardija treba primijeniti terapiju antikolinergičkim lijekovima kao što je atropin.
English: The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed.
Croatian: Preporučena doza sugamadeksa ovisi o dubini neuromuskularne blokade koju je potrebno prekinuti.
English: T4/T1 to 0.9
Croatian: Povrat T4/T1 na 0,9
English: After the last dose of rocuronium or vecuronium, at 1-2 PTCs, 4 mg/kg sugammadex or 70 mcg/kg neostigmine was administered in a randomised order.
Croatian: Nakon zadnje doze rokuronija ili vekuronija, pri PTC-u od 1-2, primijenjen je nasumičnim redoslijedom ili sugamadeks u dozi od 4 mg/kg ili neostigmin u dozi od 70 µg/kg.
English: Neostigmine (50 mcg/kg)
Croatian: Neostigmin (50 mcg/kg)
English: A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade.
Croatian: Doza od 2 mg/kg sugamadeksa preporučuje se u slučaju da je nakon blokade izazvane rokuronijem ili vekuronijem nastupio spontani oporavak do najmanje one razine pri kojoj se ponovno pojavio T2.
English: T4/T1 to 0.7
Croatian: Povrat T4/T1 na 0,7
English: It is unknown whether sugammadex is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se sugamadeks u majčino mlijeko u ljudi.
English: Bridion will be given to you by your anaesthetist.
Croatian: Kako se daje Bridion Bridion će Vam dati anesteziolog.
English: Sugammadex has only been administered as a single bolus injection in clinical trials.
Croatian: Sugamadeks se u kliničkim ispitivanjima primjenjivao samo u obliku jednokratne bolusne injekcije.
English: T4/T1 to 0.8
Croatian: Povrat T4/T1 na 0,8
English: The time from start of administration of sugammadex or neostigmine to recovery of the T4/T1 ratio to 0.9 was:
Croatian: Vrijeme od početka primjene sugamadeksa ili neostigmina do povrata omjera T4/T1 na vrijednost 0,9 bilo je kako slijedi:
English: Sugammadex provided faster reversal of neuromuscular blockade induced by rocuronium compared to neostigmine reversal of neuromuscular blockade induced by cis-atracurium:
Croatian: Sugamadeks je doveo do brže reverzije neuromuskularne blokade izazvane rokuronijem nego neostigmin kod neuromuskularne blokade izazvane cis-atrakurijem:
English: Reversal by sugammadex of the neuromuscular blockade induced by rocuronium was compared to the reversal by neostigmine of the neuromuscular blockade induced by cis-atracurium.
Croatian: Reverzija neuromuskularne blokade, izazvane rokuronijem pomoću sugamadeksa, uspoređena je s reverzijom neuromuskularne blokade izazvane cis-atrakurijem pomoću neostigmina.
English: A dose of 23 mg sodium is considered essentially ‘sodium-free'.
Croatian: Smatra se da je doza od 23 mg natrija zanemariva količina natrija.
English: Studies in patients with hepatic impairment have not been conducted.
Croatian: Nisu provedena ispitivanja u bolesnika s oštećenjem funkcije jetre.
English: Interactions potentially affecting the efficacy of other medicinal products (capturing interactions): Due to the administration of sugammadex, certain medicinal products could become less effective due to a lowering of the (free) plasma concentrations.
Croatian: Zbog primjene sugamadeksa, neki lijekovi mogu postati manje djelotvorni uslijed smanjenja koncentracije (slobodnog lijeka) u plazmi.
English: After the last dose of rocuronium or vecuronium, at the reappearance of T2, 2 mg/kg sugammadex or 50 mcg/kg neostigmine was administered in a randomised order.
Croatian: Nakon zadnje doze rokuronija ili vekuronija, pri ponovnoj pojavi T2 je nasumičnim redoslijedom primijenjen ili sugamadeks u dozi od 2 mg/kg ili neostigmin u dozi 50 mcg/kg.
English: Time (minutes) from administration of sugammadex at 3 minutes after rocuronium to recovery of the T4/T1 ratio to 0.9, 0.8 or 0.7
Croatian: Vrijeme (u minutama) od primjene sugamadeksa 3 minute nakon rokuronija do povrata omjera T4/T1 na vrijednosti 0,9, 0,8 ili 0,7
English: The use of sugammadex in term newborn infants and infants is therefore not recommended until further data become available.
Croatian: Stoga, dok se ne prikupe dodatni podaci, ne preporučuje se primjena sugamadeksa u terminske novorođenčadi i dojenčadi.
English: IV
Croatian: N
English: In a study in volunteers doses of 4 mg/kg and 16 mg/kg of sugammadex resulted in maximum mean prolongations of the activated partial thromboplastin time (aPTT) by 17 and 22% respectively and prothrombin time international normalized ratio [PT(INR)] by 11 and 22% respectively.
Croatian: U ispitivanju s dobrovoljcima, doza sugamadeksa od 4 mg/kg rezultirala je maksimalnom srednjom vrijednošću produljenja aktiviranog parcijalnog tromboplastinskog vremena (aPTV) za 17%, a protrombinskog vremena internacionalnog normaliziranog omjera [PV(INR)] za 11%, dok je doza sugamadeksa od 16 mg/kg dovela do maksimalne srednje vrijednosti produljenja aPTV-a za 22% i PV-a (INR) također za 22%.
English: In a pooled analysis the following recovery times for 16 mg/kg sugammadex after 1.2 mg/kg rocuronium bromide were reported:
Croatian: U analizi objedinjenih podataka prijavljeno je sljedeće vrijeme oporavka kod primjene sugamadeksa u dozi od 16 mg/kg nakon blokade izazvane rokuronijevim bromidom u dozi od 1,2 mg/kg:
English: • using anticoagulants who receive a dose of 16 mg/kg sugammadex.
Croatian: • koji uzimaju antikoagulanse i prime dozu sugamadeksa od 16 mg/kg.
English: Caution should be exercised when administering sugammadex to pregnant women.
Croatian: Sugamadeks se u trudnica mora primjenjivati uz oprez.
English: Sugammadex concentrations were no longer detectable beyond 7 days post-dose in subjects with severe renal insufficiency.
Croatian: Koncentracije sugamadeksa 7 dana nakon primjene doze u ispitanika s teškim zatajivanjem bubrega nisu se više mogle izmjeriti.
English: Treatment regimen Sugammadex (4 mg/kg)
Croatian: Režim liječenja Sugamadeks (4 mg/kg)
English: How Bridion is given
Croatian: Kako se primjenjuje Bridion
English: Based on PK modelling the recommended waiting time in patients with mild or moderate renal impairment for re-use of 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium after routine reversal with sugammadex should be 24 hours.
Croatian: Na temelju farmakokinetičkog modeliranja, smatra se da preporučeni vremenski razmak nakon rutinske reverzije blokade sugamadeksom i ponovne primjene rokuronija u dozi od 0,6 mg/kg ili vekuronija u dozi od 0,1 mg/kg u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega treba biti 24 sata.
English: The infusion line should be adequately flushed (e.g., with 0.9% sodium chloride) between administration of Bridion and other drugs.
Croatian: Između primjene lijeka Bridion i drugih lijekova infuzijsku liniju je potrebno odgovarajuće isprati (npr. 0,9%-tnom otopinom natrijevog klorida).
English: Treatment regimen Sugammadex (2 mg/kg)
Croatian: Režim liječenja Sugamadeks (2 mg/kg)
English: Exposure was 2-fold and 5-fold higher in subjects with moderate and severe renal impairment, respectively.
Croatian: Izloženost je bila 2 puta viša u ispitanika s umjerenim oštećenjem funkcije bubrega, odnosno 5 puta viša u onih s teškim oštećenjem funkcije bubrega.
English: Rocuronium
Croatian: Rokuronij
English: It is not known whether sugammadex can pass into breast milk.
Croatian: Nije poznato izlučuje li se sugamadeks u majčino mlijeko.
English: A dose of 4 mg/kg sugammadex is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium or vecuronium induced blockade.
Croatian: Preporučuje se doza od 4 mg/kg sugamadeksa ako je nakon blokade izazvane rokuronijem ili vekuronijem po tetaničkoj stimulaciji postignut oporavak od najmanje 1-2 PTC-a (engl. post-tetanic counts, PTC).
English: Neither sugammadex nor the complex of sugammadex and rocuronium binds to plasma proteins or erythrocytes, as was shown in vitro using male human plasma and whole blood.
Croatian: Kako se pokazalo in vitro na uzorcima plazme i pune krvi muškaraca, ni slobodni sugamadeks ni kompleks sugamadeksa i rokuronija ne vežu se za proteine u plazmi niti za eritrocite.
English: Bridion 100 mg/mL solution for injection sugammadex
Croatian: Bridion 100 mg/ml otopina za injekciju sugamadeks
English: At the reappearance of T2 a dose of 2 mg/kg sugammadex or 50 mcg/kg neostigmine was administered.
Croatian: Pri ponovnoj pojavi T2 primijenjen je sugamadeks u dozi od 2 mg/kg ili neostigmin u dozi od 50 mcg/kg.
English: Obese patients:
Croatian: Pretili bolesnici:
English: Bradycardia may occasionally lead to cardiac arrest.
Croatian: Bradikardija može u nekim slučajevima dovesti do srčanog zastoja (vidjeti dio 4.8).
English: In a study in volunteers doses of 4 mg/kg and 16 mg/kg of sugammadex resulted in maximum mean prolongations of aPTT by 17 and 22% respectively and of PT(INR) by 11 and 22% respectively.
Croatian: U ispitivanju s dobrovoljcima, doza sugamadeksa od 4 mg/kg rezultirala je maksimalnom srednjom vrijednošću produljenja aktiviranog parcijalnog tromboplastinskog vremena (aPTV) za 17%, a protrombinskog vremena (PV) [INR] za 11%, dok je doza sugamadeksa od 16 mg/kg dovela do maksimalne srednje vrijednosti produljenja aPTV-a za 22% i PV-a (INR) također za 22%.
English: In a pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Croatian: U ključnom ispitivanju, bolesnici su nasumično raspoređeni u skupinu koja je primala rokuronij ili u skupinu koja je primala vekuronij.
English: For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required.
Croatian: Kod blagog do umjerenog oštećenja funkcije jetre nije potrebno prilagođavati dozu, jer se sugamadeks uglavnom izlučuje putem bubrega.
English: Time (minutes) from administration of rocuronium and sugammadex or succinylcholine to recovery of the T1 10%
Croatian: Vrijeme (u minutama) od primjene rokuronija i sugamadeksa ili sukcinilkolina do povratka T1 10% Neuromuskularni blokator
English: Bridion 100 mg/mL injection sugammadex
Croatian: Bridion 100 mg/ml injekcija sugamadeks i.v.
English: 1 mL contains 100 mg sugammadex (as sugammadex sodium).
Croatian: 1 ml sadrži 100 mg sugamadeksa (u obliku sugamadeksnatrija).
English: Treatment regimen Rocuronium and sugammadex (16 mg/kg)
Croatian: Režim liječenja Rokuronij i sugamadeks (16 mg/kg) Sukcinilkolin (1 mg/kg)
English: Re-administration of rocuronium or vecuronium after sugammadex: For waiting times for re-administration of rocuronium or vecuronium after reversal with sugammadex, see section 4.4.
Croatian: Za informacije o vremenskom razmaku od reverzije blokade sugamadeksom do ponovne primjene rokuronija ili vekuronija, vidjeti dio 4.4.
English: Neostigmine (70 mcg/kg)
Croatian: Neostigmin (70 µg/kg)
English: Moderate 15 11 (22) Severe 5 3 (22)
Croatian: 23 kg umjereno 15 11 (22) teško
English: Each vial of 5 mL contains 500 mg sugammadex (as sugammadex sodium).
Croatian: Jedna bočica od 5 ml sadrži 500 mg sugamadeksa (u obliku sugamadeksnatrija).
English: → Tell your anaesthetist if this applies to you.
Croatian: → Ako se to odnosi na Vas, obavijestite o tome svog anesteziologa.
English: Drug hypersensitivity reactions (see section 4.4)
Croatian: Poremećaji imunološkog sustava manje često reakcije preosjetljivosti na lijek (vidjeti dio 4.4)
English: Use for reversal of neuromuscular blocking agents other than rocuronium or vecuronium: Sugammadex should not be used to reverse block induced by nonsteroidal neuromuscular blocking agents such as succinylcholine or benzylisoquinolinium compounds.
Croatian: Sugamadeks se ne smije koristiti za reverziju neuromuskularne blokade izazvane nesteroidnim neuromuskularnim blokatorima, kao što su spojevi sukcinilkolina ili benzilizokinolina.
English: In another pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Croatian: U drugom su ključnom ispitivanju bolesnici nasumično raspoređeni u skupinu koja je primala rokuronij ili u skupinu koja je primala vekuronij.
English: Your anaesthetist will help you decide whether to stop breast-feeding, or whether to abstain from sugammadex therapy, considering the benefit of breast-feeding to the baby and the benefit of Bridion to the mother.
Croatian: Uzimajući u obzir korist dojenja za dijete i korist liječenja lijekom Bridion za majku, Vaš anesteziolog pomoći će Vam odlučiti da li da prekinete dojiti ili da se suzdržite od liječenja sugamadeksom.
English: Vecuronium
Croatian: Vekuronij
English: 1 mL solution for injection contains sugammadex sodium equivalent to 100 mg sugammadex.
Croatian: 1 ml otopine za injekciju sadrži 100 mg sugamadeksa u obliku sugamadeksnatrija.
English: Time (minutes) from administration of sugammadex or neostigmine at deep neuromuscular blockade (1-2 PTCs) after rocuronium or vecuronium to recovery of the T4/T1 ratio to 0.9 Neuromuscular blocking agent
Croatian: Vrijeme (u minutama) od primjene sugamadeksa ili neostigmina pri dubokoj neuromuskularnoj blokadi (PTC 1-2) izazvanoj rokuronijem ili vekuronijem do povratka omjera T4/T1 na vrijednost 0,9
English: Time (minutes) from administration of sugammadex or neostigmine at reappearance of T2 after rocuronium or vecuronium to recovery of the T4/T1 ratio to 0.9
Croatian: Vrijeme (u minutama) od primjene sugamadeksa ili neostigmina pri ponovnoj pojavi T2 nakon rokuronija ili vekuronija do povrata omjera T4/T1 na vrijednost 0,9
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com
Croatian: Česká republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 dpoc_czechslovak@merck.com
English: Time (minutes) from administration of sugammadex or neostigmine at reappearance of T2 after rocuronium or cis-atracurium to recovery of the T4/T1 ratio to 0.9
Croatian: Vrijeme (u minutama) od primjene sugamadeksa ili neostigmina pri ponovnoj pojavi T2 nakon primjene rokuronija ili cis-atrakurija do povrata omjera T4/T1 na vrijednost 0,9
English: In preclinical and clinical studies no metabolites of sugammadex have been observed and only renal excretion of the unchanged product was observed as the route of elimination.
Croatian: U pretkliničkim i kliničkim ispitivanjima nije opažen niti jedan metabolit sugamadeksa.
English: VIAL LABEL, 10 x 2 mL vials
Croatian: NALJEPNICA BOČICE, 10 x 2 ml bočice
English: Moderate 29 27 (22) Severe 10 8 (21)
Croatian: 15 godina oštećena blago 48 44 (23) 56 kg umjereno 29 27 (22) teško 10 8 (21)
English: VIAL LABEL, 10 x 5 mL vials
Croatian: NALJEPNICA BOČICE, 10 x 5 ml bočice
English: Each vial of 2 mL contains 200 mg sugammadex (as sugammadex sodium).
Croatian: Jedna bočica od 2 ml sadrži 200 mg sugamadeksa (u obliku sugamadeksnatrija).
English: Interactions potentially affecting the efficacy of sugammadex (displacement interactions):
Croatian: Interakcije koje mogu utjecati na djelotvornost drugih lijekova (interakcije zbog vezanja drugih lijekova):
English: Moderate 30 31 (23) Severe 10 9 (22)
Croatian: 40 godina oštećena blago 50 51 (22) 75 kg umjereno 30 31 (23) teško 10 9 (22)
English: Hepatic impairment:
Croatian: Plitka anestezija:
English: Waiting times for re-administration with neuromuscular blocking agents after reversal with sugammadex:
Croatian: Vremenski razmak između reverzije blokade sugamadeksom i ponovne primjene neuromuskularnih blokatora:
English: Each vial of 5 mL contains sugammadex sodium equivalent to 500 mg sugammadex.
Croatian: Jedna bočica od 5 ml sadrži 500 mg sugamadeksa u obliku sugamadeksnatrija.
English: Airway Complication of Anaesthesia:
Croatian: Komplikacija anestezije na dišnim putevima:
English: Adolescent
Croatian: Dojenje
English: The onset of neuromuscular blockade may be prolonged up to approximately 4 minutes, and the duration of neuromuscular blockade may be shortened up to approximately 15 minutes after readministration of rocuronium 1.2 mg/kg within 30 minutes after sugammadex administration.
Croatian: Nakon ponovne primjene rokuronija u dozi od 1,2 mg/kg unutar 30 minuta od primjene sugamadeksa, neuromuskularna blokada možda će nastupiti s kašnjenjem do oko 4 minute, a trajanje neuromuskularne blokade može biti skraćeno za najviše oko 15 minuta.
English: OUTER CARTON, 10 x 5 mL vials
Croatian: KUTIJA, 10 x 5 ml bočice
English: OUTER CARTON, 10 x 2 mL vials
Croatian: KUTIJA, 10 x 2 ml bočice
English: Method of administration
Croatian: Režim liječenja
English: If you get any side effects, talk to your anaesthetist or other doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti anesteziologa ili drugog liječnika.
English: Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg sugammadex.
Croatian: Jedna bočica od 2 ml sadrži 200 mg sugamadeksa u obliku sugamadeksnatrija.
English: Pregnancy and breast-feeding → Tell your anaesthetist if you are pregnant or might be pregnant or if you are breast-feeding.
Croatian: → Ako ste trudni ili postoji mogućnost da ste trudni ili ako dojite, obavijestite o tome svog anesteziologa.
English: The dose
Croatian: Doza
English: 1 mL contains sugammadex sodium equivalent to 100 mg sugammadex.
Croatian: 1 ml sadrži 100 mg sugamadeksa u obliku sugamadeksnatrija.
English: Anaesthetic complication (see section 4.4)
Croatian: Ozljede, trovanja i proceduralne komplikacije često komplikacija anestezije na dišnim putevima anesteziološke komplikacije (vidjeti dio 4.4)
English: Re-administration of rocuronium or vecuronium after immediate reversal (16 mg/kg sugammadex): For the very rare cases where this might be required, a waiting time of 24 hours is suggested.
Croatian: Ponovna primjena rokuronija ili vekuronija nakon trenutne reverzije (doza do 16 mg/kg sugamadeksa):
English: 30 ml (10 mg/ml)
Croatian: U venu bočici (staklo) 30 ml (10 mg/ml)
English: 300 mg Concentrate for solution for infusion
Croatian: 300 mg koncentrat za otopinu za infuziju
English: Package size
Croatian: Put primjene Unutarnje pakovanje Veličina pakovanja