FrancophonIA/ELRC3.0 huggingface dataset:
English: Rocuronium
Maltese: Rocuronium N
English: 75 yrs
Maltese: 75 sena
English: Each mL solution contains up to 9.7 mg sodium.
Maltese: Kull mL ta' soluzzjoni fih sa 9.7 mg ta' sodium.
English: T4/T1 to 0.8
Maltese: T4/T1 sa 0.8
English: T4/T1 to 0.7
Maltese: T4/T1 sa 0.7
English: Date of first authorisation: 25 July 2008 Date of latest renewal: 21 June 2013
Maltese: Data tal-aħħar tiġdid: 21 ta' Ġunju 2013
English: T4/T1 to 0.9
Maltese: T4/T1 sa 0.9
English: Impaired Mild 50 51 (22)
Maltese: Indebolita Ħafifa 50 51 (22)
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).
Maltese: Studju randomizzat, double blind eżamina l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva għallmediċina f'voluntiera b'saħħithom li ngħataw sa 3 dożi ta' plaċebo (N=76), sugammadex 4 mg/kg (N=151) jew sugammadex 16 mg/kg (N=148).
English: Bridion contains the active substance sugammadex.
Maltese: Bridion fih is-sustanza attiva sugammadex.
English: Re-administration of sugammadex:
Maltese: sugammadex.
English: Bridion can affect hormonal contraceptives
Maltese: Bridion jista' jaffettwa l-kontraċettivi ormonali
English: Interactions potentially affecting the efficacy of sugammadex (displacement interactions):
Maltese: Interazzjonijiet li potenzjalment jistgħu jaffettwaw l-effikaċja ta' sugammadex (interazzjonijiet ta' spostament):
English: Procedural complications included coughing, tachycardia, bradycardia, movement, and increase in heart rate.
Maltese: Il-komplikazzjonijiet ta' xi proċedura inkludew sogħla, takikardija, bradikardija, moviment, u żieda fir-rata tat-taħbit tal-qalb.
English: 40 yrs
Maltese: 40 sena
English: For re-administration of sugammadex see section 4.2.
Maltese: Għall-għoti mill-ġdid ta' sugammadex ara sezzjoni 4.2.
English: Use in Intensive Care Unit (ICU):
Maltese: L-użu fit-Taqsima tal-Kura Intensiva (ICU):
English: Vecuronium
Maltese: Vecuronium N
English: Anaesthetic complication (see section 4.4)
Maltese: Kumplikazzjoni waqt illoppju (ara sezzjoni 4.4)
English: The safety of sugammadex has been evaluated in 3,519 unique subjects across a pooled phase I-III safety database.
Maltese: Is-sigurtà ta' sugammadex ġiet evalwata fi 3,519-il pazjent uniku f'database tas-sigurtà miġbura ta' fażi
English: 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)]
Maltese: Ir-reazzjonijiet avversi li ġejjin kienu rrapportati fi provi kliniċi bi plaċebo fejn l-individwi rċevew loppju u jew aġenti tal-imblokk newromuskolari (1,078 espożizzjoni ta' individwu għal sugammadex meta mqabbel ma' 544 għal plaċebo): [Komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari
English: There was no evidence of increased frequency or severity of hypersensitivity with repeat dosing of sugammadex.
Maltese: Ma kien hemm l-ebda evidenza ta' żieda fil-frekwenza jew is-severità ta' sensittività eċċessiva b'dożi ripetuti ta' sugammadex.
English: Routine reversal - moderate neuromuscular blockade:
Maltese: Treġġigħ lura ta' rutina - imblokk newromuskolari moderat:
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.
Maltese: Sugammadex ingħata f'dożi li jvarjaw minn 0.5 mg/kg sa 16 mg/kg fi studji dwar ir-rispons għad-doża ta' imblokk ikkaġunat minn rocuronium (0.6, 0.9, 1.0 u 1.2 mg/kg ta' rocuronium bromide bi u mingħajr dożi tal-manteniment) u imblokk ikkaġunat minn vecuronium (0.1 mg/kg ta' vecuronium bromide bi jew mingħajr dożi tal-manteniment) f'ħinijiet /profonditajiet different ta' l-imblokk.
English: 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.
Maltese: Wara l-għoti ta' sugammadex meta T2 deher mill-ġdid wara imblokk ikkaġunat minn rocuronium, il-ħin medjan sa l-irkuprar tal-proporzjon T4/T1 għal 0.9 fl-adulti (minn 18 sa 64 sena) kien 2.2 minuti, f'adulti anzjani (minn 65 sa 74 sena) kien ta' 2.6 minuti u f'adulti anzjani ħafna (75 sena jew iktar) kien ta' 3.6 minuti.
English: Pharmacotherapeutic group: all other therapeutic products, antidotes, ATC code: V03AB35
Maltese: Kategorija farmakoterapewtika: il-prodotti terapewtiċi l-oħrajn kollha, antidoti, Kodiċi ATC:
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.
Maltese: Fi studju ieħor li qabbel individwi b'indeboliment renali moderat jew sever ma' individwi b'funzjoni renali normali, l-eliminazzjoni ta' sugammadex tnaqqset progressivament u t-t1/2 ġie progressivament imtawwal bi tnaqqis fil-funzjoni renali.
English: Bridion 100 mg/mL injection sugammadex
Maltese: Bridion 100 mg/mL injezzjoni sugammadex IV
English: The observed steady-state volume of distribution of sugammadex is approximately 11 to 14 litres in adult patients with normal renal function (based on conventional, non-compartmental pharmacokinetic analysis).
Maltese: Il-volum tad-distribuzzjoni fl-istat fiss osservat b'sugammadex hu ta' madwar 11 sa 14-il litru f'pazjenti adulti b'funzjoni renali normali (ibbażat fuq analiżi konvenzjonali farmakokinetika mhux kompartimentali).
English: 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.
Maltese: Is-sintomi assoċjati ma' dawn ir-reazzjonijiet jistgħu jinkludu: fwawar, urtikarja, raxx eritematosi (sever), pressjoni baxxa, takikardja, nefħa fl-ilsien, nefħa fil-griżmejn, bronkospażmu u avvenimenti ta' imblokk tal-pulmun.
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).
Maltese: F'esperimenti in vitro, kienet osservata interazzjoni farmakodinamika (titwil ta' PTT u PT) ma' antagonisti ta' vitamina K, eparina mhux frazzjonata, eparinojdi b'piż molekulari baxx, rivaroxaban u dabigatran (ara sezzjoni 4.4).
English: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections
Maltese: Hydrochloric acid 3.7% (għal aġġustament tal-pH) u/jew sodium hydroxide (għal aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Interference with this test is observed at sugammadex plasma concentrations of 100 microgram/mL (peak plasma level following 8 mg/kg bolus injection).
Maltese: Kienet osservata interferenza ma' dan it-test f'konċentrazzjonijiet fil-plażma ta' sugammadex ta' 100 mikrogramma/mL (livell massimu fil-plażma wara injezzjoni bolus ta' 8 mg/kg).
English: Routine reversal:
Maltese: Treġġigħ lura ta' rutina:
English: A limited database suggests that the safety profile of sugammadex (up to 4 mg/kg) in paediatric patients was similar to that in adults.
Maltese: Database limitata tissuġġerixxi li l-profil tas-sigurtà ta' sugammadex (sa 4 mg/kg) f'pazjenti pedjatriċi kien simili għal dak fl-adulti.
English: A summary of sugammadex pharmacokinetic parameters stratified by age and renal function is presented below:
Maltese: Sommarju tal-parametri farmakokinetiċi ta' sugammadex stratifikati skont l-età u l-funzjoni renali qiegħed jiġi ppreżentat hawn taħt:
English: For paediatric patients Bridion can be diluted using sodium chloride 9 mg/mL (0.9%) to a concentration of 10 mg/mL (see section 6.3).
Maltese: Għal pazjenti pedjatriċi, Bridion jista' jkun dilwit billi tuża sodium chloride 9 mg/mL (0.9%) għal konċentrazzjoni ta' 10 mg/mL (ara sezzjoni 6.3).
English: Excipient(s) with known effect Each mL contains up to 9.7 mg sodium (see section 4.4).
Maltese: Eċċipjent(i) b'effett magħruf Kull mL fih sa 9.7 mg ta' sodium (ara sezzjoni 4.4).
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Merck Sharp & Dohme B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Merck Sharp & Dohme B.V.
English: A dose of 23 mg sodium is considered essentially ‘sodium-free'.
Maltese: Doża ta' 23 mg ta' sodium hi kkunsidrata li hi essenzjalment ‘ħielsa mis-sodium'.
English: Drug hypersensitivity reactions (see section 4.4)
Maltese: Reazzjonijiet ta' sensittività eċċessiva għall-mediċina (ara sezzjoni 4.4)
English: In general sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay.
Maltese: B'mod ġenerali, sugammadex ma jinterferixxix mat-testijiet tal-laboratorju, bl-eċċezzjoni possibbli ta' l-analiżi tas-serum progesterone.
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.
Maltese: F'esperimenti in vitro, kienet osservata interazzjoni farmakodinamika (titwil ta' PTT u PT) ma' antagonisti ta' vitamina K, eparina mhux frazzjonata, eparinojdi b'piż molekulari baxx, rivaroxaban u dabigatran.
English: • Return of muscle relaxation after the operation
Maltese: • Ritorn tar-rilassament tal-muskoli wara operazzjoni
English: Physical incompatibility has been reported with verapamil, ondansetron and ranitidine.
Maltese: L-inkompatibilità fiżika kienet irrappurtata b'verapamil, ondansetron u ranitidine.
English: You may still be given Bridion, but you need to discuss it first.
Maltese: L-ebda differenzi bejn is-sessi ma kienu osservati.
English: Sugammadex exhibits linear kinetics in the dosage range of 1 to 16 mg/kg when administered as an IV bolus dose.
Maltese: Sugammadex juri kinetika lineari fil-medda tad-dożaġġ ta' 1 sa 16 mg/kg meta jingħata bħala doża bolus IV.
English: For toremifene and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
Maltese: Għal toremifene u fusidic acid, l-interazzjonijiet ta' spostament ma setgħux ikunu esklużi (l-ebda interazzjonijiet klinikament sinifikanti li jaqbdu mhuma mistennija).
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.
Maltese: Fi studju li sar fuq voluntiera, dożi ta' 4 mg/kg u 16 mg/kg ta' sugammadex irriżulta f'medja massima fit-titwil tal-ħin attivat parzjali ta' tromboplastin (aPTT) ta' 17 u 22% rispettivament u l-proporzjon normalizzat internazzjonali tal-ħin ta' protrombin [PT(INR)] ta' 11 u 22% rispettivament.
English: Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL.
Maltese: Daqsijiet tal-pakketti: 10 kunjetti ta' 2 mL jew 10 kunjetti ta' 5 mL.
English: 15 yrs
Maltese: Normali 15 sena
English: IV
Maltese: N
English: Sugammadex can be removed using haemodialysis with a high flux filter, but not with a low flux filter.
Maltese: Sugammadex jista' jitneħħa bl-użu ta' emodijalisi b'filtru tat-tip high flux, imma mhux b'filtru tat-tip low flux.
English: Exposure was 2-fold and 5-fold higher in subjects with moderate and severe renal impairment, respectively.
Maltese: L-espożizzjoni kienet darbtejn u 5 darbiet ogħla f'individwi b'indeboliment renali moderat u sever, rispettivament.
English: 7 yrs
Maltese: 7 snin
English: Based on the clinical data-base (N=3,519) and on a specific study in 1184 patients undergoing hip fracture/major joint replacement surgery there was no clinically relevant effect of sugammadex 4 mg/kg alone or in combination with anticoagulants on the incidence of peri- or post-operative bleeding complications.
Maltese: Ibbażat fuq id-data-base klinika (N=3,519) u fuq studju speċifiku fuq 1184 pazjent waqt kirurġija għal ksur filġenbejn/sostituzzjoni ta' ġog prinċipali ma kien hemm l-ebda effett klinikament rilevanti ta' sugammadex 4 mg/kg waħdu jew flimkien ma' mediċini kontra l-koagulazzjoni tad-demm fuq linċidenza ta' kumplikazzjonijiet ta' ħruġ ta' demm qabel jew wara l-operazzjoni.
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).
Maltese: Il-ħin sa l-irkuprar minn imblokk newromuskolari kkaġunat minn succinylcholine (1 mg/kg) kien imqabbel ma' sugammadex (16 mg/kg, 3 minuti wara) - irkuprar ikkaġunat minn imblokk newromuskolari kkaġunat minn rocuronium (1.2 mg/kg).
English: In patients receiving routine post-operative prophylactic anticoagulation this pharmacodynamic interaction is not clinically relevant.
Maltese: F'pazjenti li jkunu qed jirċievu anti-koagulazzjoni profilattika ta' rutina wara operazzjoni, din l-interazzjoni farmakodinamika mhijiex klinikament rilevanti.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet tal-ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: See section 4.4 light anaesthesia.
Maltese: Ara sezzjoni 4.4 Loppju ħafif.
English: When you have some types of operations, your muscles must be completely relaxed.
Maltese: Meta jkollok xi tipi ta' operazzjonijiet, il-muskoli tiegħek iridu jkunu kompletament irrilassati.
English: These limited mean aPTT and PT(INR) prolongations were of short duration (≤ 30 minutes).
Maltese: Dawn ilmedji limitati fit-titwil ta' aPTT u PT(INR) kienu ta' ħin qasir (≤ 30 minuta).
English: Bridion 100 mg/mL may be diluted to 10 mg/mL to increase the accuracy of dosing in the paediatric population (see section 6.6).
Maltese: Bridion 100 mg/mL jista' jkun dilwit għal 10 mg/mL biex tiżdied il-preċiżjoni tad-dożaġġ filpopolazzjoni pedjatrika (ara sezzjoni 6.6)
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.
Maltese: Kumplikazzjonijiet fil-passaġġ respiratorju waqt il-loppju inkluż bucking (reżistenza) kontra t-tubu endotrakeali, sogħla, bucking ħafif, reazzjoni ta' tqanqil waqt l-operazzjoni, sogħla waqt il-proċedura anestetika jew waqt l-operazzjoni, jew nifs spontanju ta' pazjent relatat mal-proċedura anestetika.
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).
Maltese: Wara t-tqegħid fis-suq, ġew osservati każijiet iżolati ta' bradikardija evidenti u ta' bradikardija b'arrest kardijku ftit minuti wara l-għoti ta' sugammadex (ara sezzjoni 4.4).
English: Due to the administration of certain medicinal products after sugammadex, theoretically rocuronium or vecuronium could be displaced from sugammadex.
Maltese: Minħabba l-għoti ta' ċerti prodotti mediċinali wara sugammadex, teoretikament rocuronium jew vecuronium jistgħu jkunu spostati minn sugammadex.
English: Sugammadex can be administered at several time points after administration of rocuronium or vecuronium bromide:
Maltese: Sugammadex jista' jingħata f'diversi punti ta' ħinijiet wara l-għoti ta' rocuronium jew vecuronium bromide:
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.
Maltese: Fi studju li sar fuq voluntiera, dożi ta' 4 mg/kg u 16 mg/kg ta' sugammadex irriżulta f'medja massima fit-titwil ta' aPTT ta' 17 u 22% rispettivament u ta' PT (INR) b'11 u 22% rispettivament.
English: Bridion 100 mg/mL solution for injection sugammadex
Maltese: Bridion 100 mg/mL soluzzjoni għall-injezzjoni sugammadex
English: Patients on a controlled sodium diet:
Maltese: Pazjenti li qegħdin fuq dieta kkontrollata tas-sodium:
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
Maltese: Il-ħin (minuti) mill-għoti ta' sugammadex wara 3 minuti wara l-għoti ta' rocuronium sa l-irkuprar tal-proporzjon T4/T1 sa 0.9, 0.8 jew 0.7
English: 1 mL contains 100 mg sugammadex (as sugammadex sodium).
Maltese: ATTIVA(I) 1 mL fih 100 mg ta' sugammadex (bħala sugammadex sodium).
English: Other ingredients: hydrochloric acid 3.7% and/or sodium hydroxide (to adjust pH), water for injections.
Maltese: Sustanzi oħra: hydrochloric acid 3.7% u/jew sodium hydroxide (għal aġġustament tal-pH), ilma għall-injezzjonijiet.
English: Time (minutes) from administration of rocuronium and sugammadex or succinylcholine to recovery of the T1 10%
Maltese: Il-ħin (minuti) mill-għoti ta' rocuronium u sugammadex jew succinylcholine sa l-irkuprar tat-T1 10% Sustanza ta' l-imblukkatur newromuskolari
English: • Bridion can make hormonal contraceptives - including the ‘Pill', vaginal ring, implants or a hormonal IntraUterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone.
Maltese: • Bridion jista' jagħmel il-kontraċettivi ormonali - li jinkludu l-'Pillola', ċirku vaġinali, impjanti jew IntraUterine System (IUS) ormonali - inqas effettivi għax inaqqas kemm inti tirċievi millormon tal-progestogen.
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.
Maltese: Fis-sitwazzjoni eċċezzjonali ta' l-okkorrenza mill-ġdid ta' imblokk newromuskolari wara l-operazzjoni (ara sezzjoni 4.4) wara doża inizjali ta' 2 mg/kg jew 4 mg/kg ta' sugammadex, doża ripetuta ta' 4 mg/kg ta' sugammadex hi rrakkomandata.
English: Median time to recovery of the T4/T1 ratio to 0.9 is around 2 minutes (see section 5.1).
Maltese: Il-ħin medjan sa l-irkuprar tal-proporzjon T4/T1 għal 0.9 hu ta' madwar 2 minuti (ara sezzjoni 5.1).
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).
Maltese: Meta jingħataw 16 mg/kg ta' sugammadex 3 minuti wara doża bolus ta' 1.2 mg/kg ta' rocuronium bromide, ħin medjan sa l-irkuprar tal-proporzjon T4/T1 għal 0.9 ta' madwar 1.5 minuti jista' jkun mistenni (ara sezzjoni 5.1).
English: In one study, sugammadex was administered following rocuronium induced blockade at 1-2 PTCs (4 mg/kg; N=68); in the other study, sugammadex was administered at reappearance of T2 (2 mg/kg; N=30).
Maltese: Fi studju wieħed, sugammadex ingħata wara imblokk ikkaġunat minn rocuronium f'1-2 PTCs (4 mg/kg; N=68); fl-istudju l-ieħor, sugammadex ingħata meta reġa' deher T2 (2 mg/kg; N=30).
English: The data for the paediatric population are limited (one study only for reversal of rocuronium induced blockade at reappearance of T2).
Maltese: Id-dejta għall-popolazzjoni pedjatrika hi limitata (hemm studju wieħed biss dwar imblokk ikkaġunat mit-treġġigħ lura ta' rocuronium fid-dehra mill-ġdid ta' T2).
English: In a previous study of similar design, there were three adjudicated cases of anaphylaxis, all after sugammadex 16 mg/kg (incidence 2.0%).
Maltese: Fi studju preċedenti ta' disinn simili, kien hemm tliet każijiet aġġudikati ta' anafilassi, kollha wara sugammadex 16 mg/kg (inċidenza ta' 2.0%).
English: Severe allergic or allergic-like reactions can be life threatening.
Maltese: Reazzjonijiet allergiċi severi jew qishom allerġiji severi jistgħu jkunu ta' periklu għal ħajja.
English: Median time to recovery of the T4/T1 ratio to 0.9 is around 3 minutes (see section 5.1).
Maltese: Il-ħin medjan sa l-irkuprar tal-proporzjon T4/T1 għal 0.9 hu ta' madwar 3 minuti (ara sezzjoni 5.1).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: OUTER CARTON, 10 x 5 mL vials
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT, 10 x 5 mL kunjetti
English: Treatment regimen Rocuronium and sugammadex (16 mg/kg)
Maltese: Kors tat-trattament Rocuronium u sugammadex (16 mg/kg)
English: - The other ingredients are water for injections, hydrochloric acid 3.7% and/or sodium hydroxide.
Maltese: - Is-sustanzi l-oħra huma ilma għall-injezzjonijiet, hydrochloric acid 3.7% u/jew sodium hydroxide.
English: 1 mL contains sugammadex sodium equivalent to 100 mg sugammadex.
Maltese: 1 mL fih sugammadex sodium ekwivalenti għal 100 mg ta' sugammadex.
English: Based upon clinical studies, sugammadex concentrations in plasma are reduced by up to 70% after a 3 to 6-hour dialysis session.
Maltese: Ibbażat fuq studji kliniċi, il-konċentrazzjonijiet ta' sugammadex fil-plażma jitnaqqsu b'sa 70% wara sessjoni ta' dijalisi tad-demm ta' minn 3 sa 6 sigħat.
English: These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide.
Maltese: Dawn huma msejħa rilassanti tal-muskoli, u eżempji jinkludu rocuronium bromide u vecuronium bromide.
English: Sugammadex is not recommended for use in patients with severe renal impairment, including those requiring dialysis (see section 5.1).
Maltese: Sugammadex mhux irrakkomandat għall-użu f'pazjenti b'indeboliment sever renali, inkluż dawk li jeħtieġu d-dijalisi (ara sezzjoni 5.1).
English: In a study in healthy Japanese and Caucasian subjects no clinically relevant differences in pharmacokinetic parameters were observed.
Maltese: Fi studju fuq persuni Ġappuniżi u Kawkasi b'saħħithom, ma kienu osservati l-ebda differenzi klinikament rilevanti fil-parametri farmakokinetiċi.
English: 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.
Maltese: F'pazjenti adulti anestetizzati b'funzjoni renali normali, l-eliminazzjoni ta' half-life (t1/2) f'sigħat ta' sugammadex hi ta' madwar sagħtejn, u t-tneħħija stmata minn ġol plażma hi ta' madwar 88 mL/min.
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.
Maltese: Għat-treġġigħ lura ta' rutina ta' imblokk ikkaġunat minn rocuronium meta T2 jidher mill-ġdid fit-tfal u fl-adolexxenti (minn 2 sa 17-il sena) doża ta' 2 mg/kg ta' sugammadex hi rakkomandata.
English: • if you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).
Maltese: • Jekk inti allerġiku għal sugammadex jew xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).