FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: L-interazzjoni bejn 4 mg/kg ta' sugammadex u progestogen kienet imbassra li ser twassal għal tnaqqis fl-espożizzjoni għal progestogen (34% ta' l-AUC), li hu simili għat-tnaqqis osservat meta doża ta' kuljum ta' kontraċettiv orali tittieħed 12-il siegħa tard, li jista' jwassal għal tnaqqis fl-effettività tagħha.
English: Intravenous administration of fusidic acid:
Maltese: L-għoti ġol-vini ta' fusidic acid:
English: EU/1/08/466/001 EU/1/08/466/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/466/002
English: Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular blockade.
Maltese: Sapport ventilatorju hu obbligatorju għal pazjenti sakemm respirazzjoni spontanja adegwata terġa' sseħħ wara t-treġġigħ lura ta' imblokk newromuskolari.
English: How to store Bridion
Maltese: X'inhu Bridion
English: Information on healthy volunteers:
Maltese: Informazzjoni fuq voluntiera b'saħħithom:
English: What Bridion contains - The active substance is sugammadex.
Maltese: X'fih Bridion - Is-sustanza attiva hi sugammadex.
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.
Maltese: L-informazzjoni f'din is-sezzjoni hi bbażata fuq l-affinità tat-twaħħil bejn sugammadex u prodotti mediċinali oħrajn, esperimenti, studji kliniċi u simulazzjonijiet mhux kliniċi billi ntuża mudell li jikkunsidra l-effett farmakodinamiku ta' sustanzi ta' l-imblokk newromuskolari u l-interazzjoni farmakokinetika bejn sustanzi ta' l-imblokk newromuskolari u sugammadex.
English: Reports of suspected hypersensitivity were adjudicated by a blinded committee.
Maltese: Rapporti ta' sensittività eċċessiva suspettati ġew aġġudikati minn kumitat blinded.
English: For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).
Maltese: Għal kontraċettivi ormonali, interazzjoni ta' qbid li hi klinikament rilevanti ma tistax tkun eskluża (l-ebda interazzjonijiet ta' spostament mhuma mistennija).
English: Bridion 100 mg/mL solution for injection
Maltese: Bridion 100 mg/mL soluzzjoni għall-injezzjoni.
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).
Maltese: L-użu ta' dożi inqas minn dawk rakkomandati jista' jwassal għal riskju miżjud ta' rikorrenza ta' imblokk newromuskolari wara qlib inizjali u mhuwiex rakkomandat (ara sezzjoni 4.2 u sezzjoni 4.8).
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
Maltese: Il-ħin (minuti) mill-għoti ta' sugammadex jew neostigmine f'imblokk newromuskolari fond (1-2 PTCs) wara rocuronium jew vecuronium sa l-irkuprar tal-proporzjon T4/T1 sa 0.9 Aġent ta' l-imblokk newromuskolari
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.
Maltese: Għall-popolazzjoni pedjatrika: sugammadex hu indikat biss għat-treġġigħ lura ta' rutina ta' imblokk ikkaġunat minn rocuronium fit-tfal u fl-adolexxenti mill-età ta' sentejn sa 17-il sena.
English: For sugammadex no clinical data on exposed pregnancies are available.
Maltese: Għal sugammadex, m'hemmx dejta klinika dwar l-użu f'nisa tqal.
English: • Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in patients with a history of lung problems
Maltese: • Qtugħ ta' nifs minħabba bugħawwieġ fil-muskoli tal-passaġġi tan-nifs (bronkospażmu) seħħ f'pazjenti b'passat mediku ta' problemi fil-pulmuni.
English: Each vial of 5 mL contains sugammadex sodium equivalent to 500 mg sugammadex.
Maltese: Kull kunjett ta' 5 mL fih sugammadex sodium ekwivalenti għal 500 mg ta' sugammadex.
English: Bridion is administered concomitantly with neuromuscular blocking agents and anaesthetics in surgical patients.
Maltese: Bridion jingħata flimkien mal-aġenti tal-imblokk newromuskolari u anestetiċi (loppju) f'pazjenti li kellhom bżonn operazzjoni.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi ta' farmakovigilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Treatment regimen Rocuronium and sugammadex (2 mg/kg)
Maltese: Kors tat-trattament Rocuronium u sugammadex (2 mg/kg)
English: Treatment regimen Sugammadex (4 mg/kg)
Maltese: Kors tat-trattamemt Sugammadex (4 mg/kg)
English: After first opening and dilution chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 25°C.
Maltese: Wara li tinfetaħ għall-ewwel darba u d-dilwizzjoni, intweriet l-istabbiltà fiżika u kimika waqt l-użu għal 48 siegħa f'temperatura ta' 2°C sa 25°C.
English: Light anaesthesia:
Maltese: Tfal u adolexxenti:
English: Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg sugammadex.
Maltese: Kull kunjett ta' 2 mL fih sugammadex sodium ekwivalenti għal 200 mg ta' sugammadex.
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.
Maltese: L-użu ta' fusidic acid fil-fażi ta' qabel l-operazzjoni jista' joħloq xi dewmien fl-irkuprar tal-proporzjon T4/T1 sa 0.9.
English: OUTER CARTON, 10 x 2 mL vials
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT, 10 x 2 mL kunjetti
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).
Maltese: Fi studji kliniċi b'individwi kkurati b'rocuronium jew b'vecuronium, fejn sugammadex ingħata permezz ta' doża tikkettata għall-profondità tal-imblokk newromuskolari (N=2,022), kienet osservata inċidenza ta' 0.20% għall-okkorrenza mill-ġdid ta' imblokk newromuskolari kif ibbażat fuq sorveljanza newromuskolari jew l-evidenza klinika (ara sezzjoni 4.4).
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).
Maltese: L-użu ta' sugammadex f'pazjenti b'indeboliment renali sever (li jinkludu pazjenti li jeħtieġu d-dijalisi (CrCl < 30 mL/min)) mhuwiex rakkomandat (ara sezzjoni 4.4).
English: Solution for injection 10 vials
Maltese: U KONTENUT Soluzzjoni għall-injezzjoni 10 kunjetti
English: There was a single case of adjudicated anaphylaxis after the first dose of sugammadex 16 mg/kg (incidence 0.7%).
Maltese: Kien hemm każ wieħed ta' anafilassi aġġudikata wara l-ewwel doża ta' sugammadex 16 mg/kg (inċidenza ta' 0.7%).
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.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih 2 mL jew 5 mL ta' soluzzjoni f'kunjett tal-ħġieġ ta' tip I b'tappijiet tal-lastku ta' chlorobutyl, b'siġill ta' l-aluminju tat-tip crimp-cap u flip-off.
English: Each vial of 5 mL contains 500 mg sugammadex (as sugammadex sodium).
Maltese: Kull kunjett ta' 5 mL fih 500 mg ta' sugammadex (bħala sugammadex sodium). 500 mg/5 mL
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.
Maltese: Doża ta' 4 mg/kg ta' sugammadex hi rrakkomandata jekk l-irkuprar ikun laħaq mill-inqas 1-2 għadd posttetaniċi (PTC) wara imblokk ikkaġunat minn rocuronium jew vecuronium.
English: It comes in two different pack sizes, containing either 10 vials with 2 mL or 10 vials with 5 mL solution for injection.
Maltese: Jiġi f'żewġ daqsijiet ta' pakketti differenti, li jkun fihom jew 10 kunjetti ta' 2 mL jew 10 kunjetti b'soluzzjoni għall-injezzjoni ta' 5 mL.
English: Limited data are available for reversal of pancuronium induced blockade, but it is advised not to use sugammadex in this situation.
Maltese: Dejta limitata hi disponibbli għat-treġġigħ lura ta' imblokk ikkaġunat minn pancuronium, iżda hu rrakkomandat li ma tużax sugammadex f'din is-sitwazzjoni.
English: • if you have fluid retention (oedema).
Maltese: • jekk għandekx żamma tal-fluwidu (edema).
English: Treatment regimen Sugammadex (2 mg/kg)
Maltese: Kors tat--trattament Sugammadex (2 mg/kg)
English: 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.
Maltese: F'sitwazzjonijiet fejn interazzjonijiet potenzjali ta' spostament jistgħu jiġu antiċipati, il-pazjenti għandhom ikunu mmonitorjati bir-reqqa għal sinjali tal-okkorrenza mill-ġdid ta' imblokk newromuskolari (għal madwar 15-il minuta) wara l-għoti parenterali ta' prodott mediċinali ieħor li sseħħ f'perijodu ta' 7.5 sigħat wara l-għoti ta' sugammadex.
English: There were no reports of anaphylaxis after placebo or sugammadex 4 mg/kg.
Maltese: Ma kien hemm ebda rapport ta' anafilassi wara plaċebo jew sugammadex 4 mg/kg.
English: Immediate reversal of rocuronium-induced blockade:
Maltese: Treġġigħ lura immedjat ta' imblokk ikkaġunat minn rocuronium:
English: In a pooled analysis the following recovery times for 16 mg/kg sugammadex after 1.2 mg/kg rocuronium bromide were reported:
Maltese: F'analiżi miġbura, il-ħinijiet li ġejjin ta' l-irkuprar għal 16 mg/kg ta' sugammadex wara 1.2 mg/kg ta' rocuronium bromide kienu rrappurtati:
English: Sugammadex should only be administered by, or under the supervision of an anaesthetist.
Maltese: Sugammadex għandu jingħata biss minn, jew taħt is-superviżjoni ta' anestetista.
English: 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.
Maltese: Dan jista' jintuża fl-adulti kull meta jingħata rocuronium bromide jew vecuronium bromide u fit-tfal u fl-adolexxenti (mill-età ta' sentejn sa 17-il sena) meta jingħata rocuronium bromide għal livell moderat ta' rilassament.
English: Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade:
Maltese: Sugammadex jista' jintuża biex ireġġa' lura livelli differenti ta' imblokk newromuskolari kkaġunat minn rocuronium jew vecuronium:
English: Sugammadex provided faster reversal of neuromuscular blockade induced by rocuronium compared to neostigmine reversal of neuromuscular blockade induced by cis-atracurium:
Maltese: Sugammadex ipprovda treġġigħ lura iktar mgħaġġel ta' l-imblokk newromuskolari kkaġunat minn rocuronium meta mqabbel mat-treġġigħ lura ta' imblokk newromuskolari ta' neostigmine ikkaġunat minn cis-atracurium:
English: Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and volunteers (for information on volunteers, see Information on healthy volunteers below).
Maltese: Kien hemm reazzjonijiet ta' sensittività eċċessiva, li jinkludu anafilassi, f'xi pazjenti u voluntieri (għal informazzjoni dwar voluntiera b'saħħithom, ara Informazzjoni dwar voluntiera b'saħħithom hawn taħt).
English: Re-administration of rocuronium or vecuronium after routine reversal (up to 4 mg/kg sugammadex):
Maltese: L-għoti mill-ġdid ta' rocuronium jew vecuronium wara t-treġġigħ lura ta' rutina (sa 4 mg/kg ta' sugammadex):
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity potential, and toxicity to reproduction, local tolerance or compatibility with blood.
Maltese: Tagħrif ta' qabel l-użu kliniku, ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, effett tossiku fuq is-sistema riproduttiva, tolleranza lokali jew kompatibilità mad-demm, ma juri l-ebda periklu speċjali għall-bnedmin.
English: For single use only Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
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.
Maltese: La sugammadex u lanqas il-kumpless ta' sugammadex u rocuronium ma jeħlu malproteini tal-plażma jew ma' l-eritroċiti, kif intwera in vitro bl-użu ta' plażma umana ta' l-irġiel u demm sħiħ.
English: Additional information on special populations
Maltese: Informazzjoni addizzjonali dwar popolazzjonijiet speċjali
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.
Maltese: Jifforma kumpless ma' l-aġenti ta' l-imblokk newromuskolari rocuronium jew vecuronium fil-plażma u b'hekk inaqqas l-ammont ta' aġent ta' l-imblokk newromuskolari disponibbli biex teħel mar-riċetturi nikotiniċi fil-junction newromuskolari.
English: • toremifene (used to treat breast cancer).
Maltese: • toremifene (jintuża għall-kura tal-kanċer tas-sider).
English: In general, Bridion does not have an effect on laboratory tests.
Maltese: B'mod ġenerali, Bridion m'għandu l-ebda effett fuq it-testijiet tal-laboratorju.
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
Maltese: Il-ħin (minuti) mill-għoti ta' sugammadex jew neostigmine meta T2 deher mill-ġdid wara rocuronium jew cis-atracurium sa l-irkuprar tal-proporzjon T4/T1 sa 0.9
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.
Maltese: Għal indeboliment renali ħafif u moderat (tneħħija tal-krejatinina ta' ≥ 30 u < 80 mL/min): ir-rakkomandazzjonijiet tad-doża huma l-istess bħal dawk ta' l-adulti mingħajr indeboliment renali.
English: The dose
Maltese: Id-doża
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.
Maltese: Sugammadex m'għandux jintuża biex ireġġa' lura l-imblokk ikkaġunat minn mediċini ta' l-imblokk newromuskolari mhux sterojdi bħal sustanzi komposti ta' succinylcholine jew benzylisoquinolinium.
English: 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.
Maltese: Fid-dejta ta' wara t-tqegħid fis-suq u fi prova klinika waħda ddedikata f'pazjenti b'passat mediku ta' kumplikazzjonijiet pulmonari, il-bronkospażmu kien irrappurtat bħala li hu possibbilment avveniment avvers relattat .
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
Maltese: Il-ħin (minuti) mill-għoti ta' sugammadex jew neostigmine meta T2 deher mill-ġdid wara rocuronium jew vecuronium sa l-irkuprar tal-proporzjon T4/T1 sa 0.9
English: • with hereditary vitamin K dependent clotting factor deficiencies;
Maltese: • b'defiċjenzi ereditarji tal-fattur tat-tagħqid tad-demm li jiddependu fuq vitamina K;
English: Moderate 15 11 (22) Severe 5 3 (22)
Maltese: Moderata 15 11 (22) Severa 5 3 (22) CV= koeffiċjent tal-varjazzjoni
English: The most commonly reported adverse reactions in surgical patients were cough, airway complication of anaesthesia, anaesthetic complications, procedural hypotension and procedural complication (Common (≥ 1/100 to < 1/10)).
Maltese: L-iktar reazzjonijiet avversi rrappurtati rrappurtati b'mod komuni f'pazjenti li kellhom bżonn operazzjoni kienu sogħla, kumplikazzjoni fil-passaġġ respiratorju mil-loppju, kumplikazzjonijiet anestetiċi, pressjoni baxxa waqt xi proċedura u komplikazzjoni ta' xi proċedura (Komuni (≥ 1/100 sa < 1/10)).
English: Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.
Maltese: It-treġġigħ lura ta' imblokk newromuskolari kkaġunat minn rocuronium jew vecuronium fl-adulti.
English: Frequency not known
Maltese: Frekwenza mhux magħrufa
English: In a human tolerance study sugammadex was administered in doses up to 96 mg/kg.
Maltese: Fi sudju dwar it-tolleranza fil-bniedem, sugammadex ingħata f'dożi sa 96 mg/kg.
English: Each vial of 2 mL contains 200 mg sugammadex (as sugammadex sodium).
Maltese: Kull kunjett ta' 2 mL fih 200 mg ta' sugammadex (bħala sugammadex sodium). 200 mg/2 mL
English: The usual dose is 2-4 mg per kg body weight.
Maltese: Id-doża normali hi ta' minn 2 sa 4 mg għal kull kg ta' piż tal-ġisem.
English: • Allergic (drug hypersensitivity) reactions - such as a rash, red skin, swelling of your tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, sometimes resulting in a serious decrease of blood pressure.
Maltese: • Reazzjonijiet allerġiċi (sensittività eċċessiva għall-mediċina) - bħal raxx, ġilda ħamra, nefħa tal-ilsien u/jew tal-griżmejn, qtugħ ta' nifs, bidliet fil-pressjoni tad-demm jew ir-rata tal-qalb, li xi kultant jistgħu jikkaġunaw tnaqqis fil-pressjoni tad-demm serja.
English: • If you get any side effects, talk to your anaesthetist or other doctor.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lill-anestetista jew lit-tabib tiegħek.
English: Treatment with anti-cholinergic agents such as atropine should be administered if clinically significant bradycardia is observed.
Maltese: Għandha tingħata kura b'sustanzi anti-kolinerġiċi jekk tiġi osservata bradikardija li tkun klinikament sinifikanti.
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.
Maltese: Fi studji kliniċi b'individwi kkurati b'rocuronium jew b'vecuronium, fejn sugammadex ingħata permezz ta' doża ttikkettjata għall-profondità ta' imblokk newromuskolari, ġiet osservata inċidenza ta' 0.20% għar-rikorrenza ta' imblokk newromuskolari kif ibbażat fuq monitoraġġ newromuskolari jew evidenza klinika.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tel/Tél: +32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.
Maltese: Fl-adulti tista' tingħata doża ta' 16 mg/kg jekk ikun meħtieġ irkuprar urġenti mir-rilassament tal-muskoli.
English: In case hepatic impairment is accompanied by coagulopathy see the information on the effect on haemostasis.
Maltese: Fil-każ li l-indeboliment epatiku jkun akkumpanjat minn koagulopatija, ara l-informazzjoni dwar l-effett fuq l-emostasi.
English: 96% of the dose was excreted in urine, of which at least 95% could be attributed to unchanged sugammadex.
Maltese: 96% tad-doża tneħħiet fl-awrina, li minnha, mill-inqas 95% tista' tkun attribwita għal sugammadex mhux mibdul.
English: Clear and colourless to slightly yellow solution.
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: It does this by combining with the rocuronium bromide or vecuronium bromide in your body.
Maltese: Jagħmel dan billi jikkombina ma' rocuronium bromide jew vecuronium bromide f'ġismek.
English: Total exposure to sugammadex was prolonged, leading to 17-fold higher exposure in patients with severe renal impairment.
Maltese: L-espożizzjoni totali għal sugammadex twalet, u dan wassal għal bejn wieħed u ieħor espożizzjoni ta' 17-il darba ogħla f'pazjenti b'indeboliment sever renali.
English: The recommended dose does not depend on the anaesthetic regimen.
Maltese: Id-doża rrakkomandata ma tiddependix fuq il-kors anestetiku.
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).
Maltese: Għandha tingħata attenzjoni meta jiġi kkunsidrat lużu ta' sugammadex f'pazjenti b'indeboliment epatiku sever jew meta l-indeboliment epatiku jkun akkumpanjat minn koagulopatija (ara sezzjoni 4.4).
English: If more than 2.4 mL solution needs to be administered, this should be taken into consideration by patients on a controlled sodium diet.
Maltese: Jekk soluzzjoni ta' iktar minn 2.4 mL tkun trid tingħata, dan għandu jitqies f'pazjenti li jikkontrollaw l-ammont ta' sodium li jieħdu fid-dieta.
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.
Maltese: Wara l-aħħar doża ta' rocuronium jew vecuronium, f'1-2 PTCs, 4 mg/kg ta' sugammadex jew 70 mcg/kg ta' neostigmine ngħata f'ordni fortuwitu Il-ħin mill-bidu ta' l-għoti ta' sugammadex jew neostigmine sa l-irkuprar tal-proporzjon T4/T1 sa 0.9 kien:
English: If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended.
Maltese: Jekk ikun hemm ħtieġa klinika għal treġġigħ lura immedjat wara l-għoti ta' rocuronium, doża ta' 16 mg/kg ta' sugammadex hi rrakkomandata.
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 f'10 persuni)
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.
Maltese: L-aġent tal-imblokk newromuskolari depolarizzanti jista' jibda jaħdem aktar bil-mod milli mistenni, għaliex frazzjoni sostanzjali ta' riċetturi nikotiniċi postjunctional jistgħu jkunu għadhom okkupati mill-aġent talimblokk newromuskolari.
English: Interactions due to the lasting effect of rocuronium or vecuronium:
Maltese: Interazzjonijiet minħabba l-effett li jdum ta' rocuronium jew vecuronium:
English: In clinical trials of surgical patients these reactions were reported uncommonly and for post-marketing reports the frequency is unknown.
Maltese: Fil-provi kliniċi ta' pazjenti li kellhom bżonn operazzjoni dawn ir-reazzjonijiet kienu rapportati b'mod mhux komuni u għal rapporti ta' wara t-tqegħid fis-suq il-frekwenza mhix magħrufa.
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.
Maltese: Il-bidu tal-imblokk newromuskolari jista' jkun imtawwal sa madwar 4 minuti, u ż-żmien li jdum għaddej l-imblokk newromuskolari jista' jitqassar għal madwar 15-il minuta wara l-għoti mill-ġdid ta' rocuronium 1.2 mg/kg fi ħdan 30 minuta wara l-għoti ta' sugammadex.