FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Če se sugamadeks v odmerku 16 mg/kg uporabi 3 minute po dajanju bolusa rokuronijevega bromida v odmerku 1,2 mg/kg, je pričakovana mediana vrednost časa do povrnitve razmerja T4/T1 na 0,9 približno 1,5 minute (glejte poglavje 5.1).
English: The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments, clinical studies and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the pharmacokinetic interaction between neuromuscular blocking agents and sugammadex.
Slovenian: Podatki, navedeni v tem poglavju, temeljijo na vezavni afiniteti sugamadeksa za druga zdravila ter na različnih predkliničnih poskusih, kliničnih študijah in simulacijah z uporabo modela ob upoštevanju farmakodinamičnega učinka mišičnih relaksantov in farmakokinetičnega medsebojnega delovanja mišičnih relaksantov in sugamadeksa.
English: For toremifene and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
Slovenian: Pri toremifenu in fusidni kislini ni mogoče izključiti možnosti izpodrivanja zdravila iz kompleksa (ni pa pričakovati klinično pomembnih interakcij vezave drugih zdravil).
English: Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent.
Slovenian: Sugamadeks je prirejen gama ciklodekstrin, ki je selektiven vezalec mišičnih relaksantov.
English: • using anticoagulants who receive a dose of 16 mg/kg sugammadex.
Slovenian: • ki jemljejo antikoagulante in prejmejo sugamadeks v odmerku 16 mg/kg.
English: In general, Bridion does not have an effect on laboratory tests.
Slovenian: Sugamadeks na splošno ne vpliva na izvide laboratorijskih preiskav.
English: Your anaesthetist will work out the dose of Bridion you need based on:
Slovenian: Odmerek zdravila Bridion, ki ga potrebujete, bo določil anesteziolog na podlagi:
English: Following a second dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function.
Slovenian: Po drugem odmerku sugamadeksa je treba bolnika natančno nadzirati in se prepričati, če je mišična funkcija zadostna.
English: In clinical studies, 1 case of an accidental overdose with 40 mg/kg was reported without any significant adverse reactions.
Slovenian: V kliničnih študijah so poročali o enem primeru nenamernega prevelikega odmerjanja sugamadeksa z odmerkom 40 mg/kg, v katerem bolnik ni imel nikakršnih pomembnih neželenih učinkov.
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.
Slovenian: Če pa uporablja druga hormonska kontracepcijska sredstva, ki se ne jemljejo peroralno, mora v naslednjih 7 dnevih uporabljati še dodatno, nehormonsko kontracepcijsko metodo in upoštevati navodila za uporabo kontraceptiva.
English: Caution should be exercised when considering the use of sugammadex in patients receiving therapeutic anticoagulation for a pre-existing or comorbid condition.
Slovenian: Pri odločitvi glede predpisovanja sugamadeksa bolnikom, ki se zdravijo z antikoagulanti zaradi druge predhodno obstoječe ali sočasne bolezni, je potrebna previdnost.
English: • Complications during your procedure such as changes in heart rate, coughing or moving
Slovenian: • Zapleti med posegom, kot so spremembe srčnega utripa, kašljanje ali premikanje.
English: You should not be given Bridion
Slovenian: Zdravila Bridion ne smete dobiti
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.
Slovenian: V izjemnih primerih, ko se živčnomišična blokada po operaciji ponovi (glejte poglavje 4.4) po prejemu začetnega odmerka sugamadeksa 2 mg/kg ali 4 mg/kg, priporočamo ponovni odmerek 4 mg/kg sugamadeksa.
English: • If you have further questions, ask your anaesthetist or doctor.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z anesteziologom ali zdravnikom.
English: The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade (see section 4.4).
Slovenian: Priporočamo uporabo ustrezne tehnike za nadzor popuščanja živčnomišične blokade (glejte poglavje 4.4).
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.
Slovenian: V plazmi se veže na mišična relaksanta rokuronij ali vekuronij in z njima tvori kompleks ter tako zmanjšuje količino mišičnega relaksanta, ki je na voljo za vezavo na nikotinske receptorje v živčnomišičnem stiku.
English: When you have some types of operations, your muscles must be completely relaxed.
Slovenian: Pri nekaterih vrstah operacij morajo biti bolnikove mišice popolnoma sproščene, da bi kirurg lažje operiral.
English: No formal interaction studies have been performed.
Slovenian: Študij o medsebojnem delovanju zdravil niso izvedli.
English: Driving and using machines Bridion has no known influence on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Bridion nima znanega vpliva na sposobnost upravljanja vozil in strojev.
English: For routine reversal of rocuronium induced blockade at reappearance of T2 in children and adolescents (2-17 years) 2 mg/kg sugammadex is recommended.
Slovenian: Za rutinsko prekinitev z rokuronijem povzročene živčnomišične blokade pri ponovnem pojavu T2 pri otrocih in mladostnikih (starih 2 do 17 let) priporočamo sugamadeks v odmerku 2 mg/kg.
English: Sugammadex should be administered intravenously as a single bolus injection.
Slovenian: Sugamadeks je treba uporabljati intravensko v obliki enkratne bolusne injekcije.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Merck Sharp & Dohme B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Imetnik dovoljenja za promet z zdravilom Merck Sharp & Dohme B.V.
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.
Slovenian: Za farmakokinetična parametra, kakršna sta očistek in porazdelitveni volumen, so predpostavili, da sta pri preiskovancih v anesteziji enaka pri nevezanem sugamadeksu in sugamadeksu, vezanem v obliki kompleksov.
English: Other ingredients: hydrochloric acid 3.7% and/or sodium hydroxide (to adjust pH), water for injections.
Slovenian: Pomožne snovi: klorovodikova kislina 3,7 % in/ali natrijev hidroksid (za prilagoditev pH), voda za injekcije.
English: Succinylcholine (1 mg/kg)
Slovenian: sukcinilholin (1 mg/kg)
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).
Slovenian: V randomizirani, dvojno slepi študiji so pri zdravih prostovoljcih, ki so dobili do 3 odmerke placeba (N=76), 4 mg/kg sugamadeksa (N=151) ali 16 mg/kg sugamadeksa (N=148), preučevali pojavnost preobčutljivostnih reakcij na zdravilo.
English: After first opening and dilution, store at 2 to 8°C and use within 24 hours.
Slovenian: Po prvem odprtju in razredčitvi shranjujte pri temperaturi 2 - 8 °C in uporabite v 24 urah.
English: If neuromuscular blockade is reversed, while anaesthesia is continued, additional doses of anaesthetic and/or opioid should be given as clinically indicated.
Slovenian: Če pride med potekom anestezije do prekinitve blokade živčnomišičnega prenosa, dajte bolniku dodatne odmerke anestetika in/ali opioida, odvisno od kliničnih indikacij.
English: There was a single case of adjudicated anaphylaxis after the first dose of sugammadex 16 mg/kg (incidence 0.7%).
Slovenian: Bil je en primer ocenjene anafilaksije po prvem odmerku sugamadeksa v odmerku 16 mg/kg (pojavnost 0,7 %).
English: T4/T1 to 0.7
Slovenian: Povrnitev vrednosti T4/T1 na 0,7
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.
Slovenian: Zapleti v dihalnih poteh pri anesteziji so vključevali upor v dihalih pri manevriranju z dihalno cevko, kašljanje, blag spazem dihal, vzburjenost med operacijo, kašljanje med postopkom anestezije ali operacijo ali z anestezijo povezano spontano dihanje bolnika.
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).
Slovenian: Pri bolnikih s hudo ledvično okvaro (vključno s tistimi na dializi (CrCl < 30 ml/min)) uporabe sugamadeksa ne priporočamo (glejte poglavje 4.4).
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.
Slovenian: V študiji pri prostovoljcih je po uporabi sugamadeksa v odmerkih po 4 mg/kg in 16 mg/kg bilo največje povprečno podaljšanje aktiviranega delnega tromboplastinskega časa (aPTT) 17 oz. 22 % in mednarodnega normaliziranega razmerja protrombinskega časa [PT(INR)] 11 oz. 22 %.
English: Should neuromuscular blockade reoccur following extubation, adequate ventilation should be provided.
Slovenian: Če se živčnomišična blokada pri bolniku ponovi po odstranitvi dihalne cevke, je treba zagotoviti ustrezno umetno predihavanje.
English: Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and volunteers (for information on volunteers, see Information on healthy volunteers below).
Slovenian: Pri nekaterih bolnikih in prostovoljcih (za podatke o prostovoljcih glejte Podatki o zdravih prostovoljcih, spodaj) so se pojavile preobčutljivostne reakcije, vključno z anafilaksijo.
English: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections
Slovenian: 6.1 Seznam pomožnih snovi klorovodikova kislina 3,7 % (za prilagoditev pH) in/ali natrijev hidroksid (za prilagoditev pH) voda za injekcije
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.
Slovenian: V poskusih in vitro so opazili farmakodinamično interakcijo (podaljšanje vrednosti aPTT in PT) pri uporabi antagonistov vitamina K, nefrakcioniranega heparina, heparinoidov z nizko molekularno maso, rivaroksabana in dabigatrana.
English: Bridion will be given to you by your anaesthetist.
Slovenian: Zdravilo Bridion vam bo dal anesteziolog.
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).
Slovenian: V obdobju trženja zdravila so v nekaj minutah po uporabi sugamadeksa opazili posamezne primere izrazite bradikardije in bradikardije s srčnim zastojem (glejte poglavje 4.4).
English: In obese patients, the dose of sugammadex should be based on actual body weight.
Slovenian: Pri bolnikih s prekomerno telesno maso je odmerek sugamadeksa odvisen od bolnikove dejanske telesne mase.
English: Procedural complications included coughing, tachycardia, bradycardia, movement, and increase in heart rate.
Slovenian: S posegom povezani zapleti so vključevali kašljanje, tahikardijo, bradikardijo, premikanje in pospešeno bitje srca.
English: Use in Intensive Care Unit (ICU):
Slovenian: Uporaba na oddelkih za intenzivno nego:
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).
Slovenian: V poskusih in vitro so opazili farmakodinamično interakcijo (podaljšanje vrednosti aPTT in PT) pri uporabi antagonistov vitamina K, nefrakcioniranega heparina, heparinoidov z nizko molekularno maso, rivaroksabana in dabigatrana (glejte poglavje 4.4).
English: • with hereditary vitamin K dependent clotting factor deficiencies;
Slovenian: • ki imajo dedno pomanjkanje od vitamina K odvisnih faktorjev strjevanja krvi;
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.
Slovenian: V študijah odvisnosti odziva od odmerka zdravila so sugamadeks uporabljali v odmerkih od 0,5 mg/kg do 16 mg/kg po živčnomišični blokadi, povzročeni z rokuronijem (0,6, 0,9, 1,0 in 1,2 mg/kg rokuronijevega bromida z ali brez vzdrževalnih odmerkov), in po živčnomišični blokadi, povzročeni z vekuronijem (0,1 mg/kg vekuronijevega bromida z ali brez vzdrževalnih odmerkov), v različnih časovnih točkah blokade in na različnih stopnjah oz. globinah 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.
Slovenian: V drugi študiji, kjer so primerjali bolnike z zmerno ali hudo okvaro ledvic ter bolnike z normalnim delovanjem ledvic, se je s pešanjem delovanja ledvic očistek sugamadeksa progresivno zmanjšal, t1/2 pa progresivno podaljšal.
English: The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg.
Slovenian: raztopina za injiciranje (injekcija) bistra in brezbarvna do rahlo rumena raztopina pH vrednost raztopine je med 7 in 8, osmolalnost pa med 300 in 500 mosm/kg.
English: The infusion line should be adequately flushed (e.g., with 0.9% sodium chloride) between administration of Bridion and other drugs.
Slovenian: Infuzijsko linijo je treba med dajanjem zdravila Bridion in dajanjem drugih zdravil ustrezno sprati (npr. z 0,9 % raztopino natrijevega klorida).
English: T4/T1 to 0.8
Slovenian: Povrnitev vrednosti T4/T1 na 0,8
English: Sugammadex should only be administered by, or under the supervision of an anaesthetist.
Slovenian: Sugamadeks lahko daje le anesteziolog ali se ga daje pod nadzorom anesteziologa.
English: In a previous study of similar design, there were three adjudicated cases of anaphylaxis, all after sugammadex 16 mg/kg (incidence 2.0%).
Slovenian: V prejšnji podobno zasnovani študiji so bili trije primeri ocenjene anafilaksije, vsi po prejemu sugamadeksa 16 mg/kg (pojavnost 2,0 %).
English: • how much the muscle relaxant medicine is still affecting you.
Slovenian: • tega, koliko ste še pod vplivom mišičnega relaksanta.
English: There were no reports of anaphylaxis after placebo or sugammadex 4 mg/kg.
Slovenian: Poročil o anafilaksiji po placebu ali sugamadeksu v odmerku 4 mg/kg ni bilo.
English: If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended.
Slovenian: Če je iz kliničnih razlogov potrebna takojšnja prekinitev živčnomišične blokade po uporabi rokuronija, priporočamo uporabo sugamadeksa v odmerku 16 mg/kg.
English: In rare instances, marked bradycardia has been observed within minutes after the administration of sugammadex for reversal of neuromuscular blockade.
Slovenian: V redkih primerih so v nekaj minutah po uporabi sugamadeksa za prekinitev blokade živčnomišičnega prenosa opazili izrazito bradikardijo.
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.
Slovenian: V študiji pri prostovoljcih je uporaba sugamadeksa v odmerkih po 4 mg/kg in 16 mg/kg povzročila največje povprečno podaljšanje aPTT za 17 oz. 22 % in protrombinskega časa (PT)(INR) za 11 oz. 22 %.
English: A dose of 23 mg sodium is considered essentially ‘sodium-free'.
Slovenian: Če zdravilo vsebuje 23 mg natrija na odmerek, se smatra, da je »brez natrija«.
English: The sugammadex pharmacokinetic parameters were calculated from the total sum of non-complexbound and complex-bound concentrations of sugammadex.
Slovenian: Farmakokinetični parametri sugamadeksa so bili izračunani iz skupnega seštevka koncentracij sugamadeksa, ki je bil vezan v obliki kompleksov ali nevezan.
English: If these side effects occur while you are under anaesthesia, they will be seen and treated by your anaesthetist.
Slovenian: Če se v času anestezije pri vas pojavijo naslednji neželeni učinki, jih bo ugotovil in zdravil anesteziolog.
English: Effect on haemostasis:
Slovenian: Vpliv na hemostazo:
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.
Slovenian: Za pediatrično populacijo: sugamadeks je pri otrocih in mladostnikih, starih od 2 do 17 let, priporočljiv le za rutinsko prekinitev z rokuronijem dosežene živčnomišične blokade.
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).
Slovenian: Pri uporabi priporočenih odmerkov zdravila za rutinsko prekinitev živčnomišične blokade dosežemo nekoliko krajši čas (mediana vrednost) do povrnitve razmerja T4/T1 na 0,9 pri z rokuronijem povzročeni blokadi kot pri z vekuronijem povzročeni živčnomišični blokadi (glejte poglavje 5.1).
English: Sugammadex can be administered at several time points after administration of rocuronium or vecuronium bromide:
Slovenian: Sugamadeks lahko uporabljamo v različnih časovnih presledkih po uporabi rokuronijevega ali vekuronijevega bromida:
English: For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).
Slovenian: Pri hormonskih kontraceptivih ni mogoče izključiti klinično pomembnih interakcij zaradi vezave drugih zdravil (ni pa pričakovati interakcij zaradi izpodrivanja zdravila iz kompleksa).
English: Moderate 29 27 (22) Severe 10 8 (21)
Slovenian: 56 kg zmerno 29 27 (22) hudo 10 8 (21)
English: Median time to recovery of the T4/T1 ratio to 0.9 is around 2 minutes (see section 5.1).
Slovenian: Mediana vrednost časa, ki je potreben, da se razmerje T4/T1 povrne na 0,9, znaša okoli 2 minuti (glejte poglavje 5.1).
English: Median time to recovery of the T4/T1 ratio to 0.9 is around 3 minutes (see section 5.1).
Slovenian: Mediana vrednost časa, ki je potreben, da se razmerje T4/T1 povrne na 0,9, znaša okoli 3 minute (glejte poglavje 5.1).
English: For this, the general anaesthetic you are given includes medicines to make your muscles relax.
Slovenian: Zaradi tega pri splošni anesteziji uporabljamo tudi zdravila, ki sproščajo mišice.
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.
Slovenian: Če bolnica dobi sugamadeks na isti dan, kot je vzela peroralni kontraceptiv, naj upošteva navodila za ravnanje v primeru izpuščenega odmerka v navodilu za uporabo peroralnega kontraceptiva.
English: Median (minutes) Range
Slovenian: Mediana vrednost (min) Razpon
English: Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.
Slovenian: Prekinitev blokade živčnomišičnega prenosa, ki je nastala po uporabi rokuronija ali vekuronija, pri odraslih.
English: No residual neuromuscular blockade or recurrence of neuromuscular blockade was reported for patients with severe renal impairment in these studies.
Slovenian: V teh študijah niso poročali o rezidualni živčnomišični blokadi ali ponovni živčnomišični blokadi.
English: What Bridion contains - The active substance is sugammadex.
Slovenian: Kaj vsebuje zdravilo Bridion - Učinkovina je sugamadeks.
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.
Slovenian: V kliničnih študijah pri osebah, zdravljenih z rokuronijem ali vekuronijem, pri katerih so uporabili sugamadeks v odmerku, predpisanem za željeno stopnjo živčnomišične blokade, je bila glede na spremljanje živčnomišičnega prenosa ali kliničnih dokazov opažena 0,20 % incidenca ponovitve živčnomišične blokade.
English: Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL.
Slovenian: Velikosti pakiranj: 10 vial po 2 ml ali 10 vial po 5 ml.
English: Bridion will be given to you by your anaesthetist, or under the care of your anaesthetist.
Slovenian: Zdravilo Bridion vam bo dal anesteziolog ali ga boste prejeli pod nadzorom anesteziologa.
English: Moderate 30 31 (23) Severe 10 9 (22)
Slovenian: 75 kg zmerno 30 31 (23) hudo 10 9 (22)
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).
Slovenian: V kliničnih študijah pri osebah, zdravljenih z rokuronijem ali vekuronijem, pri katerih so uporabili sugamadeks v odmerku, predpisanem za željeno stopnjo živčnomišične blokade (N=2.022), je bila glede na spremljanje živčnomišičnega prenosa ali klinične dokaze opažena 0,20 % incidenca ponovitve živčnomišične blokade (glejte poglavje 4.4).
English: Treatment with anti-cholinergic agents such as atropine should be administered if clinically significant bradycardia is observed.
Slovenian: Če opazite klinično pomembno bradikardijo, je treba uporabiti zdravljenje z antiholinergičnimi učinkovinami, kot je atropin.
English: The recommended dose does not depend on the anaesthetic regimen.
Slovenian: Priporočeni odmerek sugamadeksa ni odvisen od vrste anestezije.
English: Low concentrations of sugammadex are detectable for at least 48 hours post-dose in patients with severe renal insufficiency.
Slovenian: Pri bolnikih s hudo ledvično insuficienco so nizke koncentracije sugamadeksa zaznavne še najmanj 48 ur po prejetem odmerku.
English: Discard any unused solution.
Slovenian: Neuporabljeno raztopino zavrzite.
English: Cis-atracurium and neostigmine (50 mcg/kg)
Slovenian: cisatrakurij in neostigmin (50 mcg/kg)
English: Recurrence of neuromuscular blockade:
Slovenian: Ponovitev živčnomišične blokade:
English: Sugammadex is not recommended for use in patients with severe renal impairment, including those requiring dialysis (see section 5.1).
Slovenian: Uporabe sugamadeksa pri bolnikih s hudo ledvično okvaro, vključno s tistimi, ki potrebujejo dializo, ne priporočamo (glejte poglavje 5.1).
English: The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed.
Slovenian: Priporočeni odmerek sugamadeksa je odvisen od globine mišične relaksacije, ki jo je treba prekiniti.