qanastek/EMEA-V3 huggingface dataset:
In the clinical program, a few cases of QTc prolongation were reported (QTc > 500 msec or QTc increases > 60 msec) in clinical trials in which patients received sugammadex in combination with sevoflurane or propofol.
Fil- programm kliniku, ftit każijiet ta ’ titwil tal- QTc kienu rrappurtati (żidiet tal- QTc > 500 msek jew QTc ta ’ > 60 msek), fi provi kliniċi li fihom il- pazjenti rċivew sugammadex flimkien ma ’ sevoflurane jew propofol.
During anaesthesia several medicinal products with the potential to prolong QTc (e. g. sevoflurane) are administered.
Waqt li jkun jingħata l- loppju, jingħataw diversi prodotti mediċinali li għandhom il- potenzjal li jtawlu l- QTc (eż. sevoflurane).
The routine precautions for treating arrhythmia should be taken into consideration.
Il- prekawzjonijiet ta ’ rutina għall- kura ta ’ l- arritmija għandhom jiġu kkunsidrati.
No interaction studies have been conducted in adults with sugammadex and other medicinal products.
Ma sarux studji dwar l- interazzjoni fl- adulti b’ sugammadex u prodotti mediċinali oħrajn.
The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments 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.
L- informazzjoni f’ din is- sezzjoni hi bbażata fuq l- affinità tat- twaħħil bejn sugammadex u prodotti mediċinali oħrajn, esperimenti 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.
Based on in-vitro data and taking into consideration pharmacokinetics and other relevant information, no clinically significant pharmacodynamic interaction with other medicinal products is expected, with exception of the following:
Ibbażat fuq dejta in- vitro u meta jiġu kkunsidrati l- farmakokinetika u informazzjoni rilevanti oħra, l- ebda interazzjonijiet farmakodinamika klinikament sinifikanti ma ’ prodotti mediċinali oħra mhi mistennija, bl- eċċezzjoni ta ’ dawn li ġejjin:
For toremifene, flucloxacillin and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
Għal toremifene, flucloxacillin u fusidic acid, l- interazzjonijiet ta ’ spostament ma setgħux ikunu esklużi (l- ebda interazzjonijiet klinikament sinifikanti li jaqbdu mhuma mistennija).
For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).
Għal kontraċettivi ormonali, interazzjoni ta ’ qbid li hi klinikament rilevanti ma tistax tkun eskluża (l- ebda interazzjonijiet ta ’ spostament mhuma mistennija).
Interactions potentially affecting the efficacy of sugammadex (see also section 4.4):
Interazzjonijiet li potenzjalment jistgħu jaffettwaw l- effikaċja ta ’ sugammadex (ara wkoll sezzjoni 4. 4):
For toremifene, which has a relatively high affinity constant and relatively high plasma concentrations, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur.
Għal toremifene, li għandu affinità kostanti relattivament għolja u konċentrazzjonijiet fil- plażma relattivament għolja, jista ’ jseħħ xi spostament ta ’ vecuronium jew rocuronium mill- kumpless ma ’ sugammadex.
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.
L- irkuprar tal- proporzjon T4/ T1 għal 0. 9 jista ’ għalhekk jittardja f’ pazjenti li jkunu rċivew toremifene fl- istess jum ta ’ l- operazzjoni.
Intravenous administration of flucloxacillin and fusidic acid:
L- għoti ġol- vini ta ’ flucloxacillin u fusidic acid:
Intravenous administration of fusidic acid and high dose flucloxacillin (infusion of 500 mg or more), may cause some displacement of rocuronium or vecuronium from sugammadex.
L- għoti ġol- vini ta ’ fusidic acid u ta ’ doża għolja ta ’ flucloxacillin (infużjoni ta ’ 500 mg jew iktar), tista ’ tikkawża xi spostament ta ’ rocuronium jew vecuronium minn sugammadex.
The use of these medicinal products in the pre-operative phase may give some delay in the recovery of the T4/ T1 ratio to 0.9.
L- użu ta ’ dawn il- prodotti mediċinali fil- fażi ta ’ qabel l- operazzjoni jista ’ joħloq xi dewmien fl- irkuprar tal - proporzjon T4/ T1 sa 0. 9.
The use of these medicinal products in the post-operative phase after routine reversal during the surveillance period of 6 hours (see section 4.4) should be avoided.
L- użu ta ’ dawn il- prodotti mediċinali fil- fażi ta ’ wara l- operazzjoni wara t - treġġigħ lura ta ’ rutina matul il- perijodu ta ’ sorveljanza ta ’ 6 sigħat (ara sezzjoni 4. 4) għandu jkun evitat.
If administration of flucloxacillin or fusidic acid within this time period can not be avoided, ventilation should be closely observed, in particular during the first 15 minutes after dosing.
Jekk l- għoti ta ’ flucloxacillin jew fusidic acid f’ dan il- perijodu ta ’ ħin ma jkunx jista ’ jiġi evitat, il- ventilazzjoni għandha tkun osservata mill- qrib, b’ mod partikulari matul l- ewwel 15- il minuta wara li jingħata d- dożaġġ.
For re-administration of sugammadex see section 4.2.
Għall- għoti mill- ġdid ta ’ sugammadex ara sezzjoni 4. 2.
Interactions potentially affecting the efficacy of other medicinal products (see also section 4.4):
6 Interazzjonijiet li potenzjalment jistgħu jaffettwaw l- effikaċja ta ’ prodotti mediċinali oħrajn (ara wkoll sezzjoni 4. 4):
Hormonal contraceptives:
Kontraċettivi ormonali:
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 missed daily dose of an oral contraceptive is taken 12 hours too late, which might lead to a reduction in effectiveness.
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 li ma tkunx ittieħdet tittieħed 12- il siegħa tard, li jista ’ jwassal għal tnaqqis fl- effettività tagħha.
For estrogens, the effect is expected to be lower.
Għall- estroġeni, l- effett hu mistenni li jkun inqas.
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).
Għalhekk, l- għoti ta ’ doża bolus ta ’ sugammadex hu kkunsidrat li hu ekwivalenti għal doża waħda ta ’ kuljum li ma titteħidx ta ’ kontraċettiv sterodji orali (jew ikkombinata jew progestogen biss).
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.
Jekk sugammadex jingħata fl- istess jum meta jittieħed kontraċettiv orali, għandha ssir referenza għal parir dwar doża li ma titteħidx, fil- fuljett ta ’ tagħrif tal- kontraċettiv orali.
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.
Fil- każ ta ’ kontraċettivi ormonali mhux orali, il- pazjenta għandha tuża metodu kontraċettiv addizzjonali mhux ormonali fis- 7 ijiem ta ’ wara u tirreferi għal parir fil- fuljett ta ’ tagħrif tal- prodott.
Interference with laboratory tests:
Tfixkil ta ’ testijiet tal- laboratorju:
6 In general sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay and some coagulation parameters (activated partial thromboplastin time prothrombin time, prothrombin time (international normalized ratio)).
B’ mod ġenerali, sugammadex ma jinterferixxix mat- testijiet tal- laboratorju, bl- eċċezzjoni possibbli ta ’ l- analiżi tas- serum progesterone u xi parametri tal- koagulazzjoni (ħin tat- tromboplastin parzjali attivat, ħin tal- protrombin, ħin tal- protrombin (proporzjon normalizzat internazzjonali)).
This interference was observed in plasma samples spiked with a concentration of sugammadex in the same range as obtained for Cmax after a dose of 16 mg/ kg.
Din l- interferenza kienet osservata f’ kampjuni tal- plażma li kienu miżjuda b’ konċentrazzjoni ta ’ sugammadex fl- istess medda bħal dik miksuba għas- Cmax wara doża ta ’ 16 mg/ kg.
The clinical relevance of these findings is uncertain as this has not been studied in patients.
Ir- rilevanza klinika ta ’ dawn is- sejbiet mhijiex ċara għax ma sar l- ebda studju dwar dan fuq il- pazjenti.
No formal interaction studies have been performed.
Ma saru l- ebda studji formali dwar l- interazzjonijiet.
The above mentioned interactions for adults and the warnings in section 4.4 should also be taken into account for the paediatric population.
L- interazzjonijiet imsemmija hawn fuq għall- adulti u t- twissijiet f’ sezzjoni 4. 4 għandhom jiġu kkunsidrati wkoll għall - popolazzjoni pedjatrika.
For sugammadex no clinical data on exposed pregnancies are available.
Għal sugammadex, m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ foetal development, parturition or postnatal development.
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju/ fetu, ħlas jew żvilupp wara t- twelid.
Caution should be exercised when administering sugammadex to pregnant women.
Wieħed għandu joqgħod attent meta jagħti sugammadex lil nisa tqal.
It is unknown whether sugammadex is excreted in human breast milk.
Mhux magħruf jekk sugammadex jitneħħiex fil- ħalib tas- sider uman.
Animal studies have shown excretion of sugammadex in breast milk.
Studji fuq bhejjem urew it- tneħħija ta ’ sugammadex fil- ħalib tas- sider.
Oral absorption of cyclodextrins in general is low and no effects on the suckling child is anticipated following a single dose to the breast-feeding woman.
B’ mod ġenerali, l- assorbiment orali ta ’ cyclodextrins hu baxx u l- ebda effetti fuq it- tarbija li tkun terda ’ mhuma antiċipati wara l- għoti ta ’ doża waħda lil mara li tkun tredda ’.
Sugammadex can be used during breast-feeding.
Sugammadex jista ’ jintuża waqt it- treddigħ.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
The safety of sugammadex has been evaluated based on an integrated safety database of approximately 1700 patients and 120 volunteers.
Is- sigurtà ta ’ sugammadex kienet evalwata bbażat fuq database dwar is- sigurtà integrata ta ’ madwar 1700 pazjent u 120 voluntiera.
The most commonly reported adverse reaction dysgeusia (metal or bitter taste) was mainly seen after doses of 32 mg/ kg sugammadex or higher.
L- iktar reazzjoni avversa rrappurtata l- aktar komuni kien it- tibdil fis- sens tat- togħma (togħma ta ’ metall jew togħma morra), li kienet osservat l- aktar wara dożi ta ’ 32 mg/ kg jew ogħla ta ’ sugammadex.
In a few individuals allergic-like reactions (i. e. flushing, erythematous rash) following sugammadex were reported of which one was a confirmed mild allergic reaction.
F’ xi individwi, reazzjonijiet bħal dawk ta ’ l- allerġija (i. e. fwawar, raxx eritematuż) kienu rrappurtati wara l- għoti ta ’ sugammadex, u waħda minnhom kienet ikkonfermata li hi reazzjonijiet allerġika ħafifa.
Body system Immune system disorders
7 Sistema tal- gisem Disturbi fis- sistema immuni
Subject incidence Uncommon (≥ 1/ 1000 to < 1/ 100)
Inċidenza fil- Pazjenti Mhux komuni (≥ 1/ 1000 sa < 1/ 100)
Undesirable effect Allergic reactions (see section 4.4)
Effett mhux mixtieq Reazzjonijiet allerġiċi (ara sezzjoni 4. 4)
Injury, poisoning and procedural complications
Korriment u avvelenament u komplikazzjonijiet
Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1000 to < 1/ 100)
Komuni (≥ 1/ 100 sa < 1/ 10)
Anaesthetic complication (see section 4.4) Unwanted awareness during anaesthesia
Kumplikazzjoni waqt il - loppju (ara sezzjoni 4. 4).
Nervous system disorders
Disturbi fis- sistema nervuża
Very common (≥ 1/ 10) in volunteers
Komuni ħafna (≥ 1/ 10) fil- voluntiera
Dysgeusia
Tibdil fis- sens tat- togħma
Anaesthetic complication:
Kumplikazzjoni waqt il- loppju:
Anaesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anaesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube.
Kumplikazzjonijiet waqt il- loppju, li huma indikattivi tar- restituzzjoni tal- funzjoni newromuskolari, jinkludu moviment ta ’ riġel/ driegħ jew tal- ġisem, jew sogħla waqt il- proċedura anestetika jew waqt l- operazzjoni, tkerrih tal- wiċċ u sefsif tat- tubu endotrakeali).
See section 4.4 light anaesthesia.
Ara sezzjoni 4. 4 Loppju ħafif.
Awareness:
Koxjenza:
In sugammadex treated subjects a few cases of awareness were reported.
F’ pazjenti kkurati b’ sugammadex, ftit każijiet ta ’ koxjenza kienu rrappurtati.
The relation to sugammadex is uncertain.
Ir- relazzjoni ma ’ sugammadex hi inċerta.
7 In the data-base of pooled phase I-III studies with a placebo group, the incidence of re-occurrence of blockade as measured with neuromuscular monitoring was 2% after sugammadex and 0% in the placebo group.
Fid- data- base ta ’ studji miġbura ta ’ fażi I- III bi grupp tal- plaċebo, l- inċidenza ta ’ l- okkorrenza mill - ġdid ta ’ imblokk kif imkejjel b’ monitoraġġ newromuskolari, kienet ta ’ 2% wara sugammadex, u 0% fil- grupp tal- plaċebo.
Virtually all of these cases were from dose-finding studies in which a sub-optimal dose (less than 2 mg/ kg) was administered (see section 4.4).
Kważi dawn il- każijiet kollha kienu minn studji dwar is- sejbien tad- doża li fihom ingħatat doża li kienet inqas mill- aħjar livell (inqas minn 2 mg/ kg) (ara sezzjoni 4. 4).
Additional information on special populations
Informazzjoni addizzjonali dwar popolazzjonijiet speċjali
Pulmonary patients:
Pazjenti pulmonari:
In one clinical trial in patients with a history of pulmonary complications bronchospasm was reported as a possibly related adverse event in two patients and a causal relationship could not be fully excluded.
Fi prova klinika waħda f’ pazjenti b’ passat mediku ta ’ kumplikazzjonijiet pulmonari, il- bronkospażmu kien irrappurtat bħala li hu possibbilment avveniment avvers relattat f’ żewġ pazjenti, u relazzjoni kawżali ma setgħetx tkun eskluża għal kollox.
As with all patients with a history of pulmonary complications the physician should be aware of the possible occurrence of bronchospasm.
Bħal fil- każ tal- pazjenti kollha b’ passat mediku ta ’ kumplikazzjonijiet pulmonari, it- tabib għandu jkun konxju mill- possibbiltà ta ’ l- okkorrenza ta ’ bronkospażmu.
A limited database suggests that the safety profile of sugammadex (up to 4 mg/ kg) in paediatric patients was similar to that in adults.
Database limitata tissuġġerixxi li l- profil tas- sigurtà ta ’ sugammadex (sa 4 mg/ kg) f’ pazjenti pedjatriċi kien simili għal dak fl- adulti.
In clinical studies, 1 case of an accidental overdose with 40 mg/ kg was reported without any significant undesirable effects.
Fi studju kliniċi, każ wieħed ta ’ doża eċċessiva aċċidentali b’ 40 mg/ kg kien irrappurtat mingħajr l- ebda effetti mhux mixtieqa sinifikanti.
In a human tolerance study sugammadex was administered in doses up to 96 mg/ kg.
Fi sudju dwar it- tolleranza fil- bniedem, sugammadex ingħata f’ dożi sa 96 mg/ kg.
No dose related adverse events nor serious adverse events were reported.
Ma kienu rrappurtati l- ebda avvenimenti avversi marbuta mad- doża u lanqas avvenimenti avversi serji.
Pharmacotherapeutic group: all other therapeutic products, ATC code:
Kategorija farmakoterapewtika: il- prodotti terapewtiċi l- oħrajn kollha, Kodiċi ATC:
V03AB35
V03AB35.
Mechanism of action:
Mekkaniżmu ta ’ l- azzjoni:
Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent.
Sugammadex hu gamma cyclodextrin modifikata li hi Aġent Selettiv Rilassanti li Jorbot.
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.
Jifforma kumpless ma ’ l- aġenti ta ’ l- imblokk newromuskolari rocuronium jew vecuronium fil- plażma u
This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Dan jirriżultata fit- treġġigħ lura ta ’ l- imblokk newromuskolari kkaġunat minn rocuronium jew vecuronium.
Pharmacodynamic effects:
Effetti farmakodinamici:
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.
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.
In these studies a clear dose-response relationship was observed.
F’ dawn l- istudji kienet osservata relazzjoni ċara bejn id- doża u r- rispons.
Clinical efficacy and safety:
L- effikaċja u s- sigurtà klinika:
Sugammadex can be administered at several time points after administration of rocuronium or vecuronium bromide:
Sugammadex jista ’ jingħata f’ diversi punti ta ’ ħinijiet wara l- għoti ta ’ rocuronium jew vecuronium bromide:
Routine reversal – deep neuromuscular blockade:
Treġġigħ lura ta ’ rutina – imblokk newromuskolari fond:
In a pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Fi studji importanti ħafna, il- pazjenti kienu assenjati b’ mod fortuwitu għall- grupp ta ’ rocuronium jew vecuronium.
The time from start of administration of sugammadex or neostigmine to recovery of the T4/ T1 ratio to 0.9 was:
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:
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
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
8 Neuromuscular blocking agent Rocuronium
newromuskolari Rocuronium
Neostigmine (70 mcg/ kg)
Neostigmine (70 mcg/ kg)
N Median (minutes) Range Vecuronium
N Medjan (minuti) Medda Vecuronium
37 2.7 1.2-16.1
37 2. 7 1. 2- 16. 1
37 49.0 13.3-145.7
37 49. 0 13. 3- 145. 7
N Median (minutes) Range
N Medjan (minuti) Medda
47 3.3 1.4-68.4
47 3. 3 1. 4- 68. 4
36 49.9 46.0-312.7
36 49. 9 46. 0- 312. 7
Routine reversal – moderate neuromuscular blockade:
Treġġigħ lura ta ’ rutina – imblokk newromuskolari moderat:
In another pivotal study patients were randomly assigned to the rocuronium or vecuronium group.
Fi studji ieħor importanti ħafna, il- pazjenti kienu assenjati b’ mod fortuwitu għall- grupp ta ’ rocuronium jew vecuronium.
The time from start of administration of sugammadex or neostigmine to recovery of the T4/ T1 ratio to 0.9 was:
Wara l- aħħar doża ta ’ rocuronium jew vecuronium, meta T2 deher mill- ġdid, ingħataw 2 mg/ kg ta ’ sugammadex jew 50 mcg/ kg ta ’ neostigmine 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:
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 Neuromuscular blocking agent Rocuronium
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 Aġent ta ’ l- imblokk
Treatment regimen Sugammadex (2 mg/ kg)
Sugammadex (2 mg/ kg)
Neostigmine (50 mcg/ kg)
Neostigmine (50 mcg/ kg)
48 1.4 0.9-5.4
48 1. 4 0. 9- 5. 4
48 17.6 3.7-106.9
48 17. 6 3. 7- 106. 9
48 2.1 1.2-64.2
48 2. 1 1. 2- 64. 2
45 18.9 2.9-76.2
45 18. 9 2. 9- 76. 2
Reversal by sugammadex of the neuromuscular blockade induced by rocuronium was compared to the reversal by neostigmine of the neuromuscular blockade induced by cis-atracurium.
9 It- treġġigħ lura permezz ta ’ sugammadex ta ’ l- imblokk newromuskolari kkaġunat minn rocuronium kien imqabbel mat- treġġigħ lura permezz ta ’ neostigmine ta ’ l- imblokk newromuskolari kkaġunat minn cis- atracurium.
At the reappearance of T2 a dose of 2 mg/ kg sugammadex or 50 mcg/ kg neostigmine was administered.
Meta T2, deher mill- ġdid, ingħatat doża ta ’ 2 mg/ kg ta ’ sugammadex jew 50 mcg/ kg ta ’ neostigmine.
Sugammadex provided faster reversal of neuromuscular blockade induced by rocuronium compared to neostigmine reversal of neuromuscular blockade induced by cis-atracurium:
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:
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 Neuromuscular blocking agent
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 Aġent ta ’ l- imblokk
Treatment regimen Rocuronium and sugammadex (2 mg/ kg)
Rocuronium u sugammadex (2 mg/ kg)
Cis-atracurium and neostigmine (50 mcg/ kg)
Cis- atracurium u neostigmine (50 mcg/ kg)
34 1.9 0.7-6.4
34 1. 9 0. 7- 6. 4
39 7.2 4.2-28.2
39 7. 2 4. 2- 28. 2
For immediate reversal:
Għal treġġigħ lura immedjat:
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).
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).
Time (minutes) from administration of rocuronium and sugammadex or succinylcholine to recovery of the T1 10%
Il- ħin (minuti) mill- għoti ta ’ rocuronium u sugammadex jew succinylcholine sa l- irkuprar tat- T1 10% Sustanza ta ’ l- imblukkatur
9 Neuromuscular blocking agent
Kors tat- trattament
Treatment regimen Rocuronium and sugammadex (16 mg/ kg)
Rocuronium u sugammadex (16 mg/ kg)
Succinylcholine (1 mg/ kg)
Succinylcholine (1 mg/ kg)
55 4.2 3.5-7.7
55 4. 2 3. 5- 7. 7
55 7.1 3.7-10.5
55 7. 1 3. 7- 10. 5
In a pooled analysis the following recovery times for 16 mg/ kg sugammadex after 1.2 mg/ kg rocuronium bromide were reported:
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:
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
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
T4/ T1 to 0.9
T4/ T1 sa 0. 9
T4/ T1 to 0.8
T4/ T1 sa 0. 8
T4/ T1 to 0.7
T4/ T1 sa 0. 7
N Median (minutes)
N Medjan (minuti) 1. 5
65 1.3
65 1. 3
65 1.1
65 1. 1
Range
Medda
0.5-14.3
0. 5- 14. 3
0.5-6.2
5- 6. 2
0.5-3.3
0. 5- 3. 3
The sugammadex pharmacokinetic parameters were calculated from the total sum of non-complex- bound and complex-bound concentrations of sugammadex.
Il- parametri farmakokinetiċi ta ’ sugammadex kienu kkalkulati mis- somma totali ta ’ konċentrazzjonijiet mhux marbutin- kumplessivamenti ta ’ sugammadex u ta ’ konċentrazzjonijiet marbutin- kumplessivament ta ’ sugammadex.
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.
Il- parametri farmakokinetiċi għax it- tneħħija u l- volum tad- distribuzzjoni huma ssoponuti li huma l- istess għal sugammadex mhux marbut- kumplessiv u għal dak marbut- kumplessiv f’ pazjenti anestetizzati.
Distribution:
Distribuzzjoni:
The steady-state volume of distribution of sugammadex is approximately 11 to 14 litres.
Il- volum tad- distribuzzjoni fl- istat fiss ta ’ sugammadex hu ta ’ madwar 11 sa 14- il litru.
Neither sugammadex nor the complex of sugammadex and rocuronium bind to plasma proteins or erythrocytes, as was shown in vitro using male human plasma and whole blood.
La sugammadex u lanqas il- kumpless ta ’ sugammadex u rocuronium ma jeħlu mal- proteini tal- plażma jew ma ’ l- eritroċiti, kif intwera in vitro bl- użu ta ’ plażma umana ta ’ l- irġiel u demm sħiħ.
Sugammadex exhibits linear kinetics in the dosage range of 1 to 16 mg/ kg when administered as an IV bolus dose.
Sugammadex juri kinetika lineari fil- medda tad- dożaġġ ta ’ 1 sa 16 mg/ kg meta jingħata bħala doża bolus IV.
Metabolism:
Metaboliżmu:
In preclinical and clinical studies no metabolites of sugammadex have been observed and only renal excretion of the unchanged product was observed as the route of elimination.
10 Fi studji ta ’ qabel l- użu kliniku u dawk kliniċi, l- ebda metaboliti ta ’ sugammadex ma kienu osservati, u t- tneħħija renali biss tal- prodott mhux mibdul kienet osservata bħala r- rotta ta ’ l- eliminazzjoni.
Elimination:
Eliminazzjoni:
The elimination half-life (t½) of sugammadex in adults is 1.8 hours and plasma clearance is estimated to be 88 ml/ min.
Il- half- life ta ’ l- eliminazzjoni (t½) ta ’ sugammadex fl- adulti hi ta ’ 1. 8 sigħat, u t- tneħħija minnġol plażma hi stmata li hi ta ’ 88 ml/ min.
A mass balance study demonstrated that > 90% of the dose was excreted within 24 hours.
Studju dwar il- bilanċ tal- massa wera li > 90% tad- doża tneħħiet fi żmien 24 siegħa.
96% of the dose was excreted in urine, of which at least 95% could be attributed to unchanged sugammadex.
96% tad- doża tneħħiet fl- awrina, li minnha, mill- inqas 95% tista ’ tkun attribwita għal sugammadex mhux mibdul.
Excretion via faeces or expired air was less than 0.02% of the dose.
It- tneħħija permezz ta ’ l- ippurgar jew l- arja li toħroġ man- nifs kienet inqas minn 0. 02% tad- doża.
Administration of sugammadex to healthy volunteers resulted in increased renal elimination of rocuronium in complex.
L- għoti ta ’ sugammadex lil voluntiera b’ saħħithom irriżulta f’ żieda fit- tneħħija renali ta ’ rocuronium fil- kumpless.
Special populations:
Popolazzjonijiet speċjali:
Elderly and renal impairment:
L- anzjani u l- indeboliment renali:
The pharmacokinetic parameters based on pharmacokinetic modelling in typical elderly and/ or renally impaired patients are presented below:
Il- parametri farmakokinetiċi bbażati fuq immudellar farmakokinetiku f’ pazjenti anzjani tipiċi u/ jew pazjenti b’ indeboliment renali huma ppreżentati hawn taħt:
Typical subject (75 kg body weight) Adult Normal CrCL:
Pazjent tipiku (75 kg ta ’ piż tal- ġisem)
(40 years) 100 ml/ min
100 ml/ min (40 sena)
Clearance (ml/ min) 88 (25.0%)
88 (25. 0%)
Volume of Distribution at Steady State (l) 11.4 (22.9%)
11. 4 (22. 9%)
Elimination half- life (h) 1.8 (32.9%)
1. 8 (32. 9%)
Adult Mild renal (40 years) impairment CrCL:
Adulti Indeboliment ħafif renali (40 sena) CrCL:
71 (23.6%)
71 (23. 6%)
11.4 (23.0%)
11. 4 (23. 0%)
2.2 (33.3%)
2. 2 (33. 3%)
Adult Moderate renal (40 years) impairment CrCL:
Adulti (40 sena)
28 (24.4%)
11. 4 (23. 5%)
11.4 (23.5%)
5. 2 (32. 9%)
5.2 (32.9%)
Anzjani (75 sena)
Elderly Normal CrCL:
CrCL normali:
(75 years) 80 ml/ min
80 ml/ min 80 (24. 0%)
13.5 (24.4%)
13. 5 (24. 4%)
2.4 (34.9%)
2. 4 (34. 9%)
Elderly Mild renal (75 years) impairment CrCL:
Anzjani (75 sena)
13.2 (24.2%)
13. 2 (24. 2%)
2.6 (34.6%)
2. 6 (34. 6%)
Elderly Moderate renal (75 years) impairment CrCL:
Anzjani (75 sena)
28 (24.7%)
13. 4 (23. 8%)
13.4 (23.8%)
6. 1 (36. 5%)
6.1 (36.5%)
Il- medja u s- CV (%) huma ippreżentati.
Paediatrics:
Pazjenti Pedjatriċi:
Pharmacokinetics in paediatric patients (n=51) with ages ranging from 0 to 17 years were evaluated using population pharmacokinetic (PK) analysis.
Il- farmakokinetika f’ pazjenti pedjatriċi (n=51) b’ etajiet li jvarjaw minn 0 sa 17- il sena kienet evalwata bl- użu ta ’ analiżi tal- farmakokinetika tal- popolazzjoni (PK).
In patients under age 18, volume of distribution and clearance increase with increasing age.
F’ pazjenti taħt l- età ta ’ 18- il sena, il- volum tad- distribuzzjoni u t- tneħħija jiżdiedu ma ’ l- età.
Variability of plasma concentrations of sugammadex in paediatric patients is comparable to the variability in adult patients.
Il- varjabilità tal- konċentrazzjonijiet fil- plażma ta ’ sugammadex f’ pazjenti pedjatriċi hi komparabbli mal- varjabilità f’ pazjenti adulti.
The pharmacokinetic (PK) parameters of two typical paediatric patients are summarised below:
Il- parametri tal- farmakokinetika (PK) ta ’ żewġ pazjenti pedjatriċi tipiċi huma murija fil- qosor hawn taħt:
PK Parameters of sugammadex in typical paediatric patients PK Parameter Elimination Half-Life (h) Volume of Distribution at Steady State (l)
Parametri tal- PK ta ’ sugammadex f’ pazjenti pedjatriċi tipiċi Parametru tal- PK
Child (Age:8 yr) 0.9 3.1
8 snin)
Adolescent (Age:
(Età:
15 yr) 1.7 9.1
15- il sena)
Clearance (ml/ min)
Tneħħija (ml/ min)
Gender:
Sess:
No gender differences were observed.
L- ebda differenzi bejn is- sessi ma kienu osservati.
Race:
11 Razza:
In a study in healthy Japanese and Caucasian subjects no clinically relevant differences in pharmacokinetic parameters were observed.
Fi studju fuq persuni Ġappuniżi u Kawkasi b’ saħħithom, ma kienu osservati l- ebda differenzi klinikament rilevanti fil- parametri farmakokinetiċi.
Limited data does not indicate differences in pharmacokinetic parameters in Black or African Americans.
Dejta limitata ma tindika l- ebda differenzi fil- parametri farmakokinetiċi f’ Amerikani jew Afrikani Suwed.
Body weight:
Piż tal- ġisem:
Population pharmacokinetic analysis of adult and elderly patients showed no clinically relevant relationship of clearance and volume of distribution with body weight.
L- analiżi farmakokinetika tal- popolazzjoni adulta u pazjenti anzjani ma wriet l- ebda relazzjoni klinikament rilevanti ta ’ tneħħija u volum ta ’ distribuzzjoni mal- piż tal- ġisem.
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.
Informazzjoni priklinikali, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, effett tossiku fuq is- sistema riproduttiva, tolleranza jew kompatibilità lokali mad- demm, ma ’ turi l- ebda periklu speċjali għall- bnedmin.
Sugammadex is rapidly cleared from most organs; however some retention of compound occurs in bone and teeth in the rat.
Sugammadex jitneħħa malajr mill- biċċa l- kbira ta ’ l- organi; madankollu sseħħ xi żamma tas- sustanza komposta fl- għadam u fis- snien fil- firien.
The most likely component involved in the reversible binding is hydroxy apatite, the inorganic matrix in these tissues.
L- iktar komponent li x’ aktarx li hu involut fit- twaħħil riversibbli hu hydroxy apatite, il- matriċi inorganika f’ dan it- tessut.
Preclinical studies in young adult and mature rats have shown that this retention does not adversely affect tooth colour or bone quality, structure, turnover and development.
Studji ta ’ qabel l- użu kliniku f’ firien żgħażagħ u firien adulti maturi wrew li din iż- żamma ma taffettwax b’ mod avvers il- kulur tas- snien jew il- kwalità, l- istruttura, turnover, l- ammont u l- iżvilupp ta ’ l- għadam.
In juvenile rats whitish discoloration was observed in the incisors and disturbance of enamel formation was observed upon repeated dosing, however at exposure levels of 48-480 times the clinical exposure at 4 mg/ kg.
Madankollu, f’ irien ġuvenili, tibdil fil- kulur li jagħti fl- abjad kien osservat fis- snien ta’ quddiem tal - ħalq, u kien osservat disturb fil- formazzjoni ta ’ l- enamel meta ngħata dożaġġ ripetut f’ livelli ta ’ espożizzjoni ta ’ 48- 480 darba ta ’ l- espożizzjoni klinika ta ’ 4 mg/ kg.
Hydrochloric acid 3.7% and or sodium hydroxide (to adjust pH) 11 Water for injections
Hydrochloric acid 3. 7% u/ jew sodium hydroxide (għal aġġustament tal- pH) Ilma għall- injezzjonijiet.
Physical incompatibility has been reported with verapamil, ondansetron and ranitidine.
L- inkompatibilità fiżika kienet irrappurtata b’ verapamil, ondansetron u ranitidine.
After first opening and dilution chemical and physical in-use stability has been demonstrated for 48 hours at 2 °C to 25 °C.
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.
From a microbiological point of view, the diluted product should be used immediately.
Minn aspett mikrobijoloġiku, il- prodott dilwit għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, iż- żmien tal- ħażna waqt l- użu u l- kundizzjonijiet ta ’ qabel l- użu huma r- responsabbiltà ta ’ dak li jużah, u normalment ma jkunux itwal minn 24 siegħa f’ temperatura ta ’ 2 °C sa 8 °C, għajr meta d- dilwizzjoni tkun saret f’ kundizzjonijiet asettiċi kkontrollati u vverifikati.
Store below 30 °C.
Aħżen f’ temperatura taħt 30 °C.
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
For storage conditions of the diluted medicinal product, see section 6.3.
Għall- kundizzjonijiet tal- ħażna tal- prodott mediċinali dilwit, ara sezzjoni 6. 3.
Single use type I glass vial closed with grey chlorobutyl rubber stoppers with aluminium crimp-cap and flip-off seal.
12 Kunjett tal- ħġieġ ta ’ tip I li jintuża darba biss, b’ tappijiet griżi tal- lastku ta ’ chlorobutyl, b’ siġill ta ’ l- aluminju tat- tip crimp- cap u flip- off.
The rubber stopper of the vial does not contain latex.
It- tapp tal- lastku tal- kunjett ma fihx latex.
Pack sizes:
Daqsijiet tal- pakketti:
10 vials of 2 ml or 10 vials of 5 ml.
10 kunjetti ta ’ 2 ml jew 10 kunjetti ta ’ 5 ml.
Not all pack-sizes may be marketed.
Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
If Bridion is administered via the same infusion line that is also used for other medicinal products, it is important that the infusion line is adequately flushed (e. g. with sodium chloride 9 mg/ ml (0.9% solution)) between administration of Bridion and medicinal products for which incompatibility with Bridion has been demonstrated or for which compatibility with Bridion has not been established.
Jekk Bridion jingħata permezz ta ’ l- istess linja ta ’ l- infużjoni li tintuża wkoll għal prodotti mediċinali oħrajn, hu importanti li l- linja ta ’ l- infużjoni titlaħlaħ b’ mod adegwat (eż. b’ 0. 9% ta ’ sodium chloride (soluzzjoni 0. 9%)) bejn l- għoti ta ’ Bridion u l- prodotti mediċinali li għalihom tkun intweriet l- inkompatibilità ma ’ Bridion, jew li għalihom il- kompatibilità ma ’ Bridion ma kinitx stabbilita.
Sugammadex 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%).
Sugammadex jista ’ jkun injettat ġol- linja ta ’ l- infużjoni kontinwa ġol- vini bis- soluzzjonijiet ta ’ ġol- vini li ġejjin: sodium chloride 9 mg/ ml (0. 9%), glucose 50 mg/ ml (5%) sodium chloride 4. 5 mg/ ml (0. 45%) u glucose 25 mg/ ml (- 2. 5%), soluzzjoni ta ’ Ringers lactate, soluzzjoni ta ’ Ringers, glucose 50 mg/ ml (5%) f’ sodium chloride 9 mg/ ml (0. 9%).
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).
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).
Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
Organon, Kloosterstraat 6, 5349 AB Oss, L- Olanda
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /
13 ANNEX II
13 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL - LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTURI TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturers responsible for batch release
Isem u indirizz tal- manifatturi responsabbli għall- ħruġ tal- lott
Box 20 NL-5340 BH Oss The Netherlands
Box 20 NL- 5340 BH Oss L- Olanda
Dublin Ireland
Dublin L- Irlanda
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta ’ tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal- manifattur responsabbli mill- ħruġ tal- lott konċernat.
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (Ara Anness I:
Summary of Product Characteristics, section 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, sezzjoni 4. 2).
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ Awtorizzazzjoni għat- Tqegħid fis- Suq irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 1. 2, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel u waqt li l- prodott jibda jinbiegħ.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġjar tar- Riskju Id- Detentur ta ’ Awtorizzazzjoni għat- Tqegħid fis- Suq irid ikun obbligat li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 2. 0 tal- Pjan dwar l- Immaniġġjar tar- Riskju (Risk Management Plan - RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (Periodic Safety Update Report - PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
15 • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA
16 A.
16 ANNESS III
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
OUTER CARTON, 10 x 5 ml vials
KARTUNA TA ’ BARRA, 10 x 5 ml kunjetti
Bridion 100 mg/ ml solution for injection sugammadex
Bridion 100 mg/ ml soluzzjoni għall- injezzjoni sugammadex
1 ml contains 100 mg sugammadex (as sodium salt).
1 ml fih 100 mg ta ’ sugammadex (bħala melħ tas- sodium).
Other ingredients: hydrochloric acid 3.7% and/ or sodium hydroxide (to adjust pH), water for injections.
Sustanzi oħra: hydrochloric acid 3. 7% u/ jew sodium hydroxide (għal aġġustament tal- pH), ilma għall- injezzjonijiet.
See leaflet for further information.
Ara l- fuljett fil- pakkett għal aktar tagħrif.
10 vials
10 kunjetti
IV Intravenous use.
IV Użu għal ġol- vini.
Discard any unused solution.
Armi kwalunkwe soluzzjoni mhux użata.
18 Store below 30 °C.
19 Aħżen f’ temperatura taħt 30 °C.
After first opening and dilution, store at 2-8 °C and use within 24 hours.
Wara l- ewwel darba li tinfetaħ il- mediċina u d- dilwizzjoni, aħżen f’ temperatura ta ’ 2- 8 °C u uża fi żmien 24 siegħa.
Organon Kloosterstraat 6 5349 AB Oss The Netherlands
Organon Kloosterstraat 6 5349 AB Oss L- Olanda
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL LABEL, 10 x 5 ml vials
TIKKETTA TAL- KUNJETT, 10 x 5 ml kunjetti
Bridion 100 mg/ ml injection sugammadex IV
Bridion 100 mg/ ml injezzjoni sugammadex IV
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON, 10 x 2 ml vials
KARTUNA TA ’ BARRA, 10 x 2 ml kunjetti
Other ingredients: hydrochloric acid 3.7% and/ or sodium hydroxide (to adjust pH), water for injections.
Sustanzi oħra: hydrochloric acid 3. 7% u/ jew sodium hydroxide (biex taġġusta pH), ilma għall- injezzjonijiet.
21 Store below 30 °C.
22 Aħżen f’ temperatura taħt 30 °C.
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL LABEL, 10 x 2 ml vials
TIKKETTA TAL- KUNJETT, 10 x 2 ml kunjetti
INFORMATION FOR THE USER
FULJETT TA ’ TAGĦRIF
Read all of this leaflet carefully before you are given this medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel ma tingħata din il- mediċina. • Żomm dan il- fuljett.
You may need to read it again. • If you have further questions, ask your anaesthetist. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your anaesthetist or other doctor.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lill- anestetista tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lill- anestetista tiegħek jew li xi tabib ieħor.
What Bridion is and what it is used for 2.
X’ inhu Bridion u għalxiex jintuża 2.
Before Bridon is given 3.
Qabel ma jingħata Bridion 3.
How Bridion is given 4.
Kif jingħata Bridion 4.
How Bridion is stored 6.
Kif jinħażen Bridion 6.
WHAT BRIDION IS AND WHAT IT IS USED FOR
X’ INHU BRIDION U GĦALXIEX JINTUŻA
Bridion is one of a group of medicines called Selective Relaxant Binding Agents.
Bridion hu wieħed minn grupp ta ’ mediċini msejħa Aġenti Selettivi Relassanti li Jorbtu.
It is used to speed up the recovery of your muscles after an operation.
Jintuża biex iħaffef l- irkuprar tal- muskoli tiegħek wara operazzjoni.
When you have some types of operation, your muscles must be completely relaxed.
Meta jkollok xi tipi ta ’ operazzjonijiet, il- muskoli tiegħek iridu jkunu kompletament irrilassati.
This makes it easier for the surgeon to do the operation.
Dan jagħmilha iktar faċli għall- kirurgu biex jagħmel l- operazzjoni.
For this, the general anaesthetic you are given includes medicines to make your muscles relax.
Biex jagħmel hekk, l- anestetiku ġenerali li tingħata jinkludi mediċini biex jirrilassaw il- muskoli tiegħek.
These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide.
Dawn huma msejħa rilassanti tal- muskoli, u eżempji jinkludu rocuronium bromide u vecuronium bromide.
Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again.
Minħabba li dawn il- mediċini wkoll jirrilassaw il- muskoli tan- nifs, ser tkun teħtieġ l- għajnuna biex tieħu n- nifs (ventilazzjoni artifiċjali) matul u wara l- operazzjoni sakemm tkun tista ’ tieħu n- nifs waħdek mill- ġdid.
Bridion is used to stop muscle relaxants working.
Bridion jintuża biex iwaqqaf ir- rilassanti tal- muskoli milli jaħdmu.
It does this by combining with the rocuronium bromide or vecuronium bromide in your body.
Jagħmel dan billi jitħallat ma ’ rocuronium bromide jew vecuronium bromide f’ ġismek.
Bridion is given to speed up your recovery from the muscle relaxant – for example, at the end of an operation to allow you to breathe normally earlier.
Bridion jingħata biex iħaffef l- irkuprar mir- rilassant tal- muskoli – per eżempju, fit- tmiem ta ’ operazzjoni, biex jippermettilek li tieħu n- nifs b’ mod normali aktar malajr.
BEFORE BRIDION IS GIVEN
QABEL MA JINGĦATA BRIDION
You should not be given Bridion • if you are allergic (hypersensitve) to sugammadex or any of the other ingredients. → Tell your anaesthetist if this applies to you.
M’ għandekx tingħata Bridion • Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal sugammadex jew kwalunkwe sustanza oħra. → Għid lill- anestetista tiegħek jekk dan japplika għalik.
Take special care with Bridion • if you have kidney disease or had in the past.
Oqgħod attent ħafna bi Bridion • jekk għandek, jew jekk fil- passat kellek mard tal- kliewi.
This is important as Bridion is removed from your body by the kidneys. • if you have heart disease or have had it in the past. • if you have liver disease or have had it in the past. • if you have fluid retention (oedema). • if you are on a controlled salt diet. → Tell your anaesthetist if any of the above applies to you.
Dan hu importanti għax Bridion jitneħħa minn ġismek permezz tal- kliewi. • jekk għandek, jew jekk fil- passat kellek mard tal- qalb. • jekk għandek, jew jekk fil- passat kellek mard tal- fwied. • jekk għandekx żamma tal- fluwidu (edema). • jekk qiegħed/ qegħda fuq dieta kkontrollata tal- melħ. → Għid lill- anestetista tiegħek jekk xi waħda minn dawn t’ hawn fuq tapplika għalik.
Taking other medicines → Please tell your anaesthetist if you are taking or have recently taken other medicines, including medicines obtained without a prescription or herbal products.
26 Meta tuża mediċini oħra → Jekk jogħġbok għid lill- anestetista tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, li jinkludu mediċini mingħajr riċetta jew li ġejjin mill- ħxejjex.
Bridion may affect other medicines or be affected by them.
Bridion jista ’ jaffettwa mediċini oħrajn jew ikun affettwat minnhom.
25 Some medicines reduce the effect of Bridion → It is especially important that you tell your anaesthetist if you have recently taken: • toremifene (used to treat breast cancer). • flucloxacillin (an antibiotic). • fusidic acid (an antibiotic).
Xi mediċini jnaqqsu l- effett ta ’ Bridion → Hu importanti b’ mod speċjali li tgħid lill- anestetista tiegħek jekk dan l- aħħar ħadt: • toremifene (jintuża għall- kura tal- kanċer tas- sider). • flucloxacillin (antibijotiku). • fusidic acid (antibijotiku).