natgillin/translations-raw huggingface dataset:
If sugammadex is administered to these patients monitoring of haemostasis and coagulation parameters is recommended.
Ako se sugamadeks daje tim bolesnicima, preporučuje se nadzor hemostaze i parametara koagulacije.
Your anaesthetist will work out the dose of Bridion you need based on:
Anesteziolog će odrediti potrebnu dozu lijeka Bridion na temelju sljedećih podataka:
Therefore the administration of a bolus dose of sugammadex is considered to be equivalent to one missed daily dose of oral contraceptive steroids (either combined or progestogen only).
Stoga se smatra da primjena bolusne doze sugamadeksa ima jednak učinak kao jedna propuštena dnevna doza oralnih steroidnih kontraceptiva (kombiniranih ili samo progestagenskih).
• Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in patients with a history of lung problems
• nedostatak zraka zbog stezanja mišića dišnih puteva (bronhospazam) javio se u bolesnika koji su već ranije imali probleme s plućima
• if you have liver disease or have had it in the past.
• ako imate ili ste ranije imali bolest jetre.
Monitoring respiratory function during recovery:
Nadzor disanja tijekom oporavka od blokade:
In post-marketing data and in one dedicated clinical trial in patients with a history of pulmonary complications, bronchospasm was reported as a possibly related adverse event.
U podacima prikupljenima nakon stavljanja u promet i u jednom posebnom kliničkom ispitivanju u bolesnika s prethodnim plućnim komplikacijama, bronhospazam je prijavljen kao štetni događaj koji bi mogao biti povezan s primjenom lijeka.
There was no evidence of increased frequency or severity of hypersensitivity with repeat dosing of sugammadex.
Nije bilo dokaza da se učestalost ili težina preosjetljivosti povećava s ponovnim doziranjem sugamadeksa.
Pulmonary patients:
Plućni bolesnici:
Preclinical studies in young adult and mature rats demonstrate that sugammadex does not adversely affect tooth colour or bone quality, bone structure, or bone metabolism.
Neklinička ispitivanja u mladih odraslih i zrelih štakora pokazala su da sugamadeks nema štetnih utjecaja na boju zuba ili kakvoću, strukturu odnosno metabolizam kostiju.
The interaction between 4 mg/kg sugammadex and a progestogen was predicted to lead to a decrease in progestogen exposure (34% of AUC) similar to the decrease seen when a daily dose of an oral contraceptive is taken 12 hours too late, which might lead to a reduction in effectiveness.
Predvidjelo se da će interakcija između sugamadeksa u dozi od 4 mg/kg i progestagena dovesti do podjednakog smanjenja izloženosti progestagenu (34% AUC-a) kao kada se dnevna doza oralnog kontraceptiva uzme 12 sati prekasno, što može umanjiti učinkovitost kontracepcije.
There is only limited experience with the use of sugammadex in infants (30 days to 2 years), and term newborn infants (less than 30 days) have not been studied.
Iskustvo s primjenom sugamadeksa u dojenčadi (u dobi od 30 dana do 2 godine) je oskudno, dok se njegova primjena u terminske novorođenčadi (mlađe od 30 dana) nije ispitivala.
Limited data are available for reversal of pancuronium induced blockade, but it is advised not to use sugammadex in this situation.
Dostupni su samo oskudni podaci o reverziji blokade izazvane pankuronijem, ali je preporuka da se u toj situaciji ne primjenjuje sugamadeks.
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.
Podaci prikazani u ovom dijelu temelje se na afinitetu vezivanja sugamadeksa za druge lijekove, nekliničkim pokusima, kliničkim ispitivanjima i simulacijama pomoću modela, uzimajući u obzir farmakodinamički učinak neuromuskularnih blokatora i farmakokinetičku interakciju između neuromuskularnih blokatora i sugamadeksa.
It can be used in adults whenever rocuronium bromide or vecuronium bromide is used and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used for a moderate level of relaxation.
Može se primijeniti u odraslih osoba kad god se primijeni rokuronijev bromid ili vekuronijev bromid te u djece i adolescenata (u dobi od 2 do 17 godina) nakon primjene rokuronijeva bromida za postizanje umjerene razine opuštenosti.
It is given as a single injection through an intravenous line.
Bridion se daje jednokratnom injekcijom kroz intravensku liniju.
Sugammadex has no effects on fracture repair and remodelling of bone.
Sugamadeks nema učinka na cijeljenje fraktura i remodeliranje kosti.
The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade (see section 4.4).
Preporučuje se primjena odgovarajuće tehnike neuromuskularnog nadzora za praćenje oporavka neuromuskularne funkcije (vidjeti dio 4.4).
Patients with severe hepatic impairment should be treated with great caution.
U bolesnika s teškim oštećenjem funkcije jetre potreban je poseban oprez.
Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade.
U bolesnika se moraju pomno pratiti hemodinamske promjene tijekom i nakon reverzije neuromuskularne blokade.
Following a second dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function.
Nakon druge doze sugamadeksa, bolesnik mora biti pod strogim nadzorom kako bi se potvrdilo da je nastupio trajan oporavak neuromuskularne funkcije.
Sugammadex should only be administered by, or under the supervision of an anaesthetist.
Sugamadeks se smije primjenjivati samo od strane ili pod nadzorom anesteziologa.
The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg.
Bistra i bezbojna do blago žuta otopina. pH vrijednost je između 7 i 8, a osmolalnost između 300 i 500 mOsm/kg.
Neuromuscular blocking agent
Neuromuskularni blokator
In adult anaesthetized patients with normal renal function the elimination half-life (t1/2) of sugammadex is about 2 hours and the estimated plasma clearance is about 88 mL/min.
U odraslih anesteziranih bolesnika s normalnom funkcijom bubrega, poluvijek eliminacije (t1/2) sugamadeksa iznosi približno 2 sata, a procijenjeni klirens iz plazme oko 88 ml/min.
Bridion can be injected into the intravenous line of a running infusion with the following intravenous solutions: sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%), sodium chloride 4.5 mg/mL (0.45%) and glucose 25 mg/mL (2.5%), Ringers lactate solution, Ringers solution, glucose 50 mg/mL (5%) in sodium chloride 9 mg/mL (0.9%).
Bridion se može ubrizgati u intravensku liniju postavljene infuzije sa sljedećim intravenskim otopinama: otopinom natrijevog klorida od 9 mg/ml (0,9%), otopinom glukoze od 50 mg/ml (5%), otopinom natrijevog klorida od 4,5 mg/ml (0,45%) i glukoze od 25 mg/ml (2,5%), Ringerovom otopinom s laktatom, Ringerovom otopinom te otopinom glukoze od 50 mg/ml (5%) u otopini natrijevog klorida od 9 mg/ml (0,9%).
In case recurrence of neuromuscular blockade is observed, the patient may require mechanical ventilation and re-administration of sugammadex (see section 4.2).
U slučaju ponovne pojave neuromuskularne blokade, možda će biti potrebno bolesniku primijeniti mehaničku ventilaciju i ponoviti davanje sugamadeksa (vidjeti dio 4.2).
In obese patients, the dose of sugammadex should be based on actual body weight.
U pretilih se bolesnika doza sugamadeksa treba temeljiti na stvarnoj tjelesnoj težini.
• with hereditary vitamin K dependent clotting factor deficiencies;
• s nasljednim nedostatkom faktora zgrušavanja ovisnih o vitaminu K;
96% of the dose was excreted in urine, of which at least 95% could be attributed to unchanged sugammadex.
Mokraćom se izluči 96% doze, pri čemu je udio neizmijenjenog sugamadeksa najmanje 95%.
In case hepatic impairment is accompanied by coagulopathy see the information on the effect on haemostasis.
Ako uz oštećenje funkcije jetre postoji i koagulopatija, vidjeti informacije o učincima na hemostazu.
Use in the paediatric population
Primjena u pedijatrijskoj populaciji
In situations when potential displacement interactions can be anticipated, patients should be carefully monitored for signs of recurrence of neuromuscular blockade (approximately up to 15 minutes) after parenteral administration of another medicinal product occurring within a period of 7.5 hours after sugammadex administration.
U situacijama kada se mogu očekivati interakcije istiskivanja lijeka, bolesnike treba strogo nadzirati (do približno 15 minuta) kako bi se uočili eventualni znakovi povrata neuromuskularne blokade nakon parenteralne primjene drugog lijeka, u razdoblju od 7,5 sati nakon primjene sugamadeksa.
In clinical studies, 1 case of an accidental overdose with 40 mg/kg was reported without any significant adverse reactions.
U kliničkim je ispitivanjima prijavljen jedan slučaj nenamjernog predoziranja, dozom od 40 mg/kg, bez značajnih nuspojava.
In a pharmacokinetic study comparing patients with severe renal impairment to patients with normal renal function, sugammadex levels in plasma were similar during the first hour after dosing, and thereafter the levels decreased faster in the control group.
U farmakokinetičkom ispitivanju, u kojem su uspoređivani bolesnici s teškim oštećenjem funkcije bubrega s onima koji imaju normalnu funkciju bubrega, razine sugamadeksa u plazmi bile su slične prvi sat nakon doziranja, a zatim su se razine brže snižavale u kontrolnoj skupini.
After administration of sugammadex at reappearance of T2 following a rocuronium induced blockade, the median time to recovery of the T4/T1 ratio to 0.9 in adults (18-64 years) was 2.2 minutes, in elderly adults (65-74 years) it was 2.6 minutes and in very elderly adults (75 years or more) it was 3.6 minutes.
Nakon primjene sugamadeksa pri ponovnoj pojavi T2 poslije blokade izazvane rokuronijem, medijan vremena povrata omjera T4/T1 na vrijednost 0,9 iznosio je 2,2 minute u odraslih osoba (18-64 godine), 2,6 minuta u starijih osoba (65-74 godine) te 3,6 minuta u vrlo starih osoba (75 i više godina).
0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium
0,6 mg/kg rokuronija ili 0,1 mg/kg vekuronija
Studies in patients with severe renal impairment do not provide sufficient safety information to support the use of sugammadex in these patients (see also section 5.1).
Ispitivanja u bolesnika s teškim oštećenjem funkcije bubrega ne pružaju dostatne podatke o sigurnosti koji bi mogli poduprijeti primjenu sugamadeksa u tih bolesnika (vidjeti i dio 5.1).
Interactions due to the lasting effect of rocuronium or vecuronium:
Interakcije zbog dugotrajnog djelovanja rokuronija ili vekuronija:
• Severe slowing of the heart and slowing of the heart up to cardiac arrest may occur when
• Jako usporavanje srca i usporavanje srca do srčanog zastoja može se javiti nakon primjene lijeka Bridion.
For toremifene, which has a relatively high binding affinity for sugammadex and for which relatively high plasma concentrations might be present, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur.
Toremifen, koji ima relativno visok afinitet vezivanja za sugamadeks i koji može postići relativno visoke koncentracije u plazmi, može djelomično istisnuti vekuronij ili rokuronij iz kompleksa sa sugamadeksom.
Oral absorption of cyclodextrins in general is low and no effect on the suckling child is anticipated following a single dose to the breast-feeding woman.
Apsorpcija ciklodekstrina nakon peroralne primjene općenito je niska pa se ne očekuje da će primjena jednokratne doze u dojilje imati učinak na dojenče.
Bridion has no known influence on the ability to drive and use machines.
Nema poznatog utjecaja lijeka Bridion na sposobnost upravljanja vozilima i rada sa strojevima.
If such a situation is observed, the clinician is advised to consider the re-administration of the medicinal product, the administration of a therapeutically equivalent medicinal product (preferably from a different chemical class) and/or nonpharmacological interventions as appropriate.
U takvoj se situaciji kliničaru savjetuje da, ovisno o slučaju, razmotri ponovnu primjenu istoga lijeka, primjenu drugog, terapijski ekvivalentnog lijeka (po mogućnosti iz druge kemijske skupine) i/ili uvođenje nefarmakoloških mjera.
The amount of progestogen lost by using Bridion is about the same as missing one oral contraceptive Pill.
Količina progestagena koja se izgubi primjenom lijeka Bridion jednaka je kao da ste propustili uzeti jednu kontracepcijsku tabletu.
In the Pooled Phase 1 database, AEs considered common (≥ 1/100 to < 1/10) or very common (≥ 1/10) and more frequent among subjects treated with sugammadex than in the placebo group, include dysgeusia (10.1%), headache (6.7%), nausea (5.6%), urticaria (1.7%), pruritus (1.7%), dizziness (1.6%), vomiting (1.2%) and abdominal pain (1.0%).
U objedinjenoj bazi podataka iz faze 1, nuspojave koje su se smatrale čestima (≥ 1/100 i < 1/10) ili vrlo čestima (≥ 1/10) i koje su bile učestalije u ispitanika liječenih sugamadeksom nego placebom uključivale su disgeuziju (10,1%), glavobolju (6,7%), mučninu (5,6%), urtikariju (1,7%), svrbež (1,7%), omaglicu (1,6%), povraćanje (1,2 %) i bol u abdomenu (1,0%).
Each mL solution contains up to 9.7 mg sodium.
Jedan ml otopine sadrži do 9,7 mg natrija.
Procedural complications included coughing, tachycardia, bradycardia, movement, and increase in heart rate.
Proceduralne komplikacije uključivale su kašljanje, tahikardiju, badikardiju, pokret i povećanje brzine otkucaja srca.
As is normal post-anaesthetic practice following neuromuscular blockade, it is recommended to monitor the patient in the immediate post-operative period for untoward events including recurrence of neuromuscular blockade.
Sukladno uobičajenoj anesteziološkoj praksi nakon neuromuskularne blokade, preporučuje se nadzirati bolesnika u razdoblju neposredno nakon operacije zbog mogućih nepovoljnih događaja, uključujući ponovnu pojavu neuromuskularne blokade.
Sugammadex is not metabolised nor excreted by the liver; therefore dedicated studies in patients with hepatic impairment have not been conducted.
Sugamadeks se ne metabolizira u jetri i ne izlučuje putem jetre; stoga nisu provedena posebna ispitivanja u bolesnika s oštećenjem funkcije jetre.
Conditions associated with prolonged circulation time such as cardiovascular disease, old age (see section 4.2 for the time to recovery in elderly), or oedematous state (e.g., severe hepatic impairment) may be associated with longer recovery times.
Stanja povezana s usporenim krvotokom, kao što su bolesti srca i krvnih žila, starija dob (vidjeti dio 4.2 za vrijeme do oporavka u starijih osoba) ili edematozna stanja (npr. teško oštećenje funkcije jetre), mogu biti povezana s produljenim vremenom oporavka od blokade.
The following adverse reactions were reported in placebo controlled trials where subjects received anaesthesia and/or neuromuscular blocking agents (1,078 subject exposures to sugammadex versus 544 to placebo): [Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000)]
Sljedeće nuspojave prijavljene su u placebom kontroliranim ispitivanjima u kojima su ispitanici primali anesteziju i/ili neuromuskularne blokatore (1078 ispitanika primilo je sugamadeks naspram 544 koji su primili placebo): [vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000)]
If neuromuscular blockade is reversed, while anaesthesia is continued, additional doses of anaesthetic and/or opioid should be given as clinically indicated.
Ako se provede reverzija neuromuskularne blokade, a nastavi se s anestezijom, treba primijeniti dodatne doze anestetika i/ili opioida, sukladno kliničkoj indikaciji.
For routine reversal of rocuronium induced blockade at reappearance of T2 in children and adolescents (2-17 years) 2 mg/kg sugammadex is recommended.
Za rutinsku reverziju blokade izazvane rokuronijem prilikom ponovne pojave T2 u djece i adolescenata (2-17 godina) preporučuje se doza od 2 mg/kg sugamadeksa.
Anaesthetic complication:
Anesteziološke komplikacije:
Should neuromuscular blockade reoccur following extubation, adequate ventilation should be provided.
Dođe li do ponovne pojave neuromuskularne blokade nakon ekstubacije, treba osigurati odgovarajuću ventilaciju pluća.
When neuromuscular blockade was reversed intentionally in the middle of anaesthesia in clinical trials, signs of light anaesthesia were noted occasionally (movement, coughing, grimacing and suckling of the tracheal tube).
Kada se tijekom kliničkih ispitivanja provela namjerna reverzija neuromuskularne blokade usred anestezije, povremeno su zabilježeni znakovi plitke anestezije (pomicanje, kašljanje, grimase i pokreti sisanja endotrahealne cijevi).
Excipient(s) with known effect Each mL contains up to 9.7 mg sodium (see section 4.4).
Pomoćna(e) tvar(i) s poznatim učinkom Jedan ml sadrži do 9,7 mg natrija (vidjeti dio 4.4).
Administration of sugammadex to healthy volunteers resulted in increased renal elimination of rocuronium in complex.
Primjena sugamadeksa u zdravih dobrovoljaca izazvala je povećanu eliminaciju rokuronija u kompleksu putem bubrega.
When medicinal products which potentiate neuromuscular blockade are used in the post-operative period special attention should be paid to the possibility of recurrence of neuromuscular blockade.
Kada se u poslijeoperacijskom periodu primjenjuju lijekovi koji pojačavaju neuromuskularnu blokadu, potrebno je obratiti posebnu pozornost na mogućnost ponovne pojave neuromuskularne blokade.
What Bridion contains - The active substance is sugammadex.
Što Bridion sadrži - Djelatna tvar je sugamadeks.
Recovery from blockade was modestly longer for patients with severe renal impairment relative to patients without renal impairment.
Oporavak od blokade trajao je nešto dulje u bolesnika s teškim oštećenjem funkcije bubrega u odnosu na bolesnike bez oštećenja funkcije bubrega.
Sugammadex exhibits linear kinetics in the dosage range of 1 to 16 mg/kg when administered as an IV bolus dose.
Sugamadeks iskazuje linearnu kinetiku u rasponu doza od 1 do 16 mg/kg kad se primjenjuje u obliku intravenskog bolusa.
Interference with this test is observed at sugammadex plasma concentrations of 100 microgram/mL (peak plasma level following 8 mg/kg bolus injection).
Utjecaj na tu pretragu je opažen pri koncentraciji sugamadeksa u plazmi od 100 mikrograma/ml (vršne vrijednosti u plazmi nakon bolusne injekcije u dozi od 8 mg/kg).
Caution should be exercised when considering the use of sugammadex in patients receiving therapeutic anticoagulation for a pre-existing or comorbid condition.
Oprez je potreban kada se razmatra primjena sugamadeksa u bolesnika koji se liječe antikoagulansima zbog već postojećih ili popratnih bolesti.
Symptoms associated with these reactions can include: flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia, swelling of tongue, swelling of pharynx, bronchospasm and pulmonary obstructive events.
Simptomi povezani s tim reakcijama mogu obuhvaćati: navale crvenila, urtikariju, eritematozni osip, (tešku) hipotenziju, tahikardiju, oticanje jezika, oticanje ždrijela, bronhospazam i plućne opstruktivne događaje.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Merck Sharp & Dohme B.V.
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet Merck Sharp & Dohme B.V.
Clinicians should be aware that the recovery of the T4/T1 ratio to 0.9 could therefore be delayed in patients who have received toremifene on the same day of the operation.
Kliničari moraju biti svjesni da će zbog toga možda trebati više vremena za povrat omjera T4/T1 na vrijednost 0,9 u bolesnika koji su na dan operacije primili toremifen.
What Bridion is
Što je Bridion
Race:
Rasa:
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).
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).
• Airway difficulties that may include coughing or moving as if you are waking or taking a breath
• poteškoće s dišnim putevima koje mogu uključivati kašljanje ili pokrete poput onih tijekom buđenja ili prilikom udisanja
In rare instances, marked bradycardia has been observed within minutes after the administration of sugammadex for reversal of neuromuscular blockade.
U rijetkim slučajevima, opažena je značajna bradikardija unutar nekoliko minuta nakon primjene sugamadeksa za reverziju neuromuskularne blokade.
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).
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).
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).
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).
Sugammadex is rapidly cleared in preclinical species, although residual sugammadex was observed in bone and teeth of juvenile rats.
Sugamadeks se brzo uklanja u laboratorijskih životinja, iako je u kostima i zubima mladih štakora primjećen rezidualni sugamadeks.
Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections
3,7%-tna kloridna kiselina (za podešavanje pH) i/ili natrijev hidroksid (za podešavanje pH) voda za injekcije
After first opening and dilution, store at 2 to 8°C and use within 24 hours.
Nakon prvog otvaranja i razrjeđivanja, čuvati na temperaturi od 2°C do 8°C i primijeniti u roku od 24 sata.
Total exposure to sugammadex was prolonged, leading to 17-fold higher exposure in patients with severe renal impairment.
Ukupna izloženost sugamadeksu bila je dulja, što je dovelo do 17 puta veće izloženosti u bolesnika s teškim oštećenjem funkcije bubrega.
Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL.
Veličine pakiranja: 10 bočica od 2 ml ili 10 bočica od 5 ml.
Low concentrations of sugammadex are detectable for at least 48 hours post-dose in patients with severe renal insufficiency.
Niske koncentracije sugamadeksa se mogu otkriti tijekom najmanje 48 sati nakon primjene doze u bolesnika s teškim oštećenjem funkcije bubrega.
In these studies a clear dose-response relationship was observed.
U tim je ispitivanjima opažena jasna korelacija između veličine doze i terapijskog odgovora.
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.
2 ml ili 5 ml otopine u staklenoj bočici (staklo tipa I) zatvorenoj čepom od klorbutilne gume i aluminijskim prstenom sa zaštitnim zatvaračem.
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.
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.
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).
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).