natgillin/translations-raw huggingface dataset:
I et studie blev sugammadex administreret efter rocuroniuminduceret blokade ved 1-2 PTCer (4 mg/kg; N=68); i det andet studie blev sugammadex administreret ved tilbagevenden af T2 (2 mg/kg; N=30).
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).
Brug af anden medicin sammen med Bridion → Fortæl det altid til anæstesilægen, hvis du tager anden medicin, har gjort det for nylig eller måske vil tage anden medicin.
Other medicines and Bridion → Tell your anaesthetist if you are taking, have recently taken or might take any other medicines.
Moderat 15 11 (22) Svært
Moderate 15 11 (22) Severe 5 3 (22)
Saltsyre 3,7% (til justering af pH) og/eller natriumhydroxid (til pH justering) Vand til injektionsvæsker
Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections
Du kan finde yderligere oplysninger om Bridion på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Sugammadex er kun administreret som en enkel bolusinjektion i kliniske forsøg.
Sugammadex has only been administered as a single bolus injection in clinical trials.
Incidensen af adjudikeret overfølsomhed var henholdsvis 1,3%, 6,6% og 9,5% i placebogruppen og grupperne med sugammadex 4 mg/kg og sugammadex 16 mg/kg.
The incidence of adjudicated hypersensitivity was 1.3%, 6.6% and 9.5% in the placebo, sugammadex 4 mg/kg and sugammadex 16 mg/kg groups, respectively.
Sugammadex har ingen effekt på heling af frakturer og remodellering af knoglevæv.
Sugammadex has no effects on fracture repair and remodelling of bone.
Der bør udvises forsigtighed, når sugammadex overvejes til patienter i behandling med terapeutiske antikoagulantia for en allerede eksisterende eller co-morbid tilstand.
Caution should be exercised when considering the use of sugammadex in patients receiving therapeutic anticoagulation for a pre-existing or comorbid condition.
Sugammadex bør ikke anvendes til revertering af neuromuskulær blokade induceret af andre steroide neuromuskulært blokerende stoffer end rocuronium eller vecuronium, eftersom der ikke findes data for effekt og sikkerhed for disse tilfælde.
Sugammadex should not be used for reversal of neuromuscular blockade induced by steroidal neuromuscular blocking agents other than rocuronium or vecuronium, since there are no efficacy and safety data for these situations.
Brug af sugammadex anbefales ikke til patienter med svært nedsat nyrefunktion (inklusive patienter med behov for dialyse (CrCl < 30 ml/min)) (se pkt.
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).
Ved dosering til overvægtige patienter bør dosis af sugammadex fastsættes i forhold til patientens faktiske kropsvægt.
In obese patients, the dose of sugammadex should be based on actual body weight.
• hvis du har eller har haft en leversygdom.
• if you have liver disease or have had it in the past.
Tiden til revertering efter succinylcholininduceret neuromuskulær blokade (1 mg/kg) blev sammenlignet med sugammadex (16 mg/kg, 3 minutter senere) - induceret revertering fra rocuronium induceret neuromuskulær blokade (1,2 mg/kg).
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).
Pakningsstørrelser: 10 hætteglas af 2 ml eller 10 hætteglas af 5 ml.
Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL.
Der var et enkelt tilfælde af adjudikeret anafylaksi efter første dosis sugammadex 16 mg/kg (incidens 0,7%).
There was a single case of adjudicated anaphylaxis after the first dose of sugammadex 16 mg/kg (incidence 0.7%).
Klar, farveløs til let gullig opløsning.
Clear and colourless to slightly yellow solution.
Virkningen af et depolariserende neuromuskulært blokerende stof kan indtræde langsommere end forventet, da en væsentlig del af nikotinreceptorerne i de neuromuskulære endeplader fortsat kan være optaget af det neuromuskulært blokerende stof.
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.
Administrationen af visse lægemidler efter sugammadex kan teoretisk set fortrænge rocuronium eller vecuronium fra sugammadex.
Due to the administration of certain medicinal products after sugammadex, theoretically rocuronium or vecuronium could be displaced from sugammadex.
Bridion indeholder det aktive stof sugammadex.
Bridion contains the active substance sugammadex.
Anæstesikomplikationer, der er indikative for genopbygning af den neuromuskulære funktion, inkluderer bevægelse af ekstremiteter eller kroppen, hoste under anæstesiproceduren eller operationen, grimasser eller sutten på endotrakealtuben.
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.
Opbevaringsforhold for det fortyndede lægemiddel se pkt.
For storage conditions of the diluted medicinal product, see section 6.3.
Sugammadex kan administreres på flere forskellige tidspunkter efter administration af rocuroniumeller vecuroniumbromid:
Sugammadex can be administered at several time points after administration of rocuronium or vecuronium bromide:
Hypotension under indgrebet
Procedural hypotension
Alvorlige allergiske eller allergilignende reaktioner kan være livstruende Allergiske reaktioner blev rapporteret hyppigere hos raske frivillige ved bevidsthed
Allergic reactions were reported more commonly in healthy, conscious volunteers
Som resultat heraf kan tilbagevenden af neuromuskulær blokade opstå.
As a result recurrence of neuromuscular blockade might be observed.
Luftvejskomplikationer forårsaget af anæstesi inkluderede modstand mod endotrakealtuben, hoste, let modstand, opvågningsreaktion under operationen, hoste under anæstesien eller under operationen eller spontan respiration relateret til anæstesiproceduren.
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.
Anvendelse til revertering af andre neuromuskulært blokerende stoffer end rocuronium/vecuronium: Sugammadex bør ikke anvendes til revertering af blokade induceret af non-steroide neuromuskulært blokerende stoffer såsom succinylcholin- eller benzylisoquinoliniumforbindelser.
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.
Rutinemæssig revertering - dyb neuromuskulær blokade:
Routine reversal - deep neuromuscular blockade:
Ventetider for gen-administration af neuromuskulært blokerende stoffer efter revertering med sugammadex:
Waiting times for re-administration with neuromuscular blocking agents after reversal with sugammadex:
En dosis på 2 mg/kg sugammadex anbefales, hvis der er sket en spontan genopvågning op til mindst genetablering af T2 efter en rocuronium- eller vecuroniuminduceret blokade.
A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade.
Unge
Child
Rutinemæssig revertering - moderat neuromuskulær blokade:
Routine reversal - moderate neuromuscular blockade:
De ovennævnte interaktioner for voksne og advarslerne i pkt.
The above mentioned interactions for adults and the warnings in section 4.4 should also be taken into account for the paediatric population.
Når 16 mg/kg sugammadex indgives 3 minutter efter en bolusinjektion på 1,2 mg/kg rocuroniumbromid, kan man forvente en mediantid på ca. 1,5 minut for revertering af T4/T1 ratioen til 0,9 (se pkt.
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).
I et studie med frivillige resulterede doser på 4 mg/kg og 16 mg/kg sugammadex i maksimale gennemsnitlige forlængelser af aktiveret partiel tromboplastintid (aPTT) på henholdsvis 17 og 22% og af protrombintid international normaliseret ratio [PT(INR)] på henholdsvis 11 og 22%.
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.
I et tidligere studie med sammenligneligt design var der tre adjudikerede tilfælde af anafylaksi, alle efter sugammadex 16 mg/kg (incidens 2,0%).
In a previous study of similar design, there were three adjudicated cases of anaphylaxis, all after sugammadex 16 mg/kg (incidence 2.0%).
Virkning og anvendelse Det skal du vide, før du får Bridion Sådan bliver du behandlet med Bridion Bivirkninger
What Bridion is and what it is used for What you need to know before Bridion is given How Bridion is given
De kaldes muskelafslappende midler, rocuroniumbromid og vecuroniumbromid er eksempler på disse.
These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide.
Lungepatienter:
Pulmonary patients:
Det danner et kompleks med de neuromuskulært blokerende stoffer rocuronium eller vecuronium i plasma og reducerer dermed mængden af neuromuskulært blokerende stoffer, der ellers vil binde til nicotin receptorerne ved den neuromuskulære endeplade.
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.
Koncentrationer af sugammadex var ikke længere detekterbare 7 dage efter dosering hos forsøgspersoner med svært nedsat nyrefunktion.
Sugammadex concentrations were no longer detectable beyond 7 days post-dose in subjects with severe renal insufficiency.
Anæstesikomplikationer (se pkt.
Anaesthetic complication (see section 4.4)
Anæstesikomplikation:
Anaesthetic complication:
I kliniske studier, hvor en ønsket revertering af neuromuskulær blokade blev foretaget midt under anæstesien, blev der af og til observeret tegn på let anæstesi (bevægelse, hoste, grimasser og sutten på det trakeale rør).
When neuromuscular blockade was reversed intentionally in the middle of anaesthesia in clinical trials, signs of light anaesthesia were noted occasionally (movement, coughing, grimacing and suckling of the tracheal tube).
I in vitro forsøg bemærkede man en farmakodynamisk interaktion (aPTT- og PT-forlængelse) med vitamin K-antagonister, ufraktioneret heparin, lavmolekylære heparinoider, rivaroxaban og dabigatran.
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.
Lægemiddeloverfølsomhedsreaktioner:
Drug hypersensitivity reactions:
• i behandling med antikoagulantia, og som får 16 mg sugammadex/kg.
• using anticoagulants who receive a dose of 16 mg/kg sugammadex.
Injektionsvæske, opløsning 10 hætteglas
Solution for injection 10 vials
Behandlingskomplikation:
Procedural Complication:
På baggrund af en farmakokinetisk modelbeskrivelse bør den anbefalede ventetid hos patienter med let eller moderat nedsat nyrefunktion med hensyn til gen-administration af 0,6 mg/kg rocuronium eller 0,1 mg/kg vecuronium efter rutinemæssig revertering med sugammadex være 24 timer.
Based on PK modelling the recommended waiting time in patients with mild or moderate renal impairment for re-use of 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium after routine reversal with sugammadex should be 24 hours.
Anæstesilægen vil overvåge din tilstand nøje, og du vil derfor næppe få for meget Bridion.
If more Bridion is given to you than recommended As your anaesthetist will be monitoring your condition carefully, it is unlikely that you will be given too much Bridion.
Dyrestudier har vist, at sugammadex udskilles i modermælken.
Animal studies have shown excretion of sugammadex in breast milk.
Det skal besluttes, om amning skal ophøre eller behandling med sugammadex seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from sugammadex therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Andre hjælpestoffer: saltsyre 3,7% og/eller natriumhydroxid (til pH justering), vand til injektionsvæsker.
Other ingredients: hydrochloric acid 3.7% and/or sodium hydroxide (to adjust pH), water for injections.
Revertering af neuromuskulær blokade induceret af rocuronium eller vecuronium hos voksne.
Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.
Bridion er en klar og farveløs til svagt gul opløsning til indsprøjtning.
What Bridion looks like and contents of the pack Bridion is a clear and colourless to slightly yellow solution for injection.
Dette resulterer i en revertering af den neuromuskulære blokade induceret af rocuronium eller vecuronium.
This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Tilbagevenden af neuromuskulær blokade:
Recurrence of neuromuscular blockade:
Hvis nedsat leverfunktion ledsages af koagulopati, se informationen vedr.
In case hepatic impairment is accompanied by coagulopathy see the information on the effect on haemostasis.
Tiden (minutter) fra administration af rocuronium og sugammadex eller succinylcholin ved genetablering af T1 10%
Time (minutes) from administration of rocuronium and sugammadex or succinylcholine to recovery of the T1 10%
Der bør derfor udvises forsigtighed, når anvendelse af sugammadex hos patienter med svært nedsat leverfunktion overvejes, eller når svært nedsat leverfunktion ledsages af koagulopati (se pkt.
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).
Anæstesilægen vil hjælpe dig med at beslutte, om amning eller behandling med sugammadex skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele ved Bridon for moderen.
Your anaesthetist will help you decide whether to stop breast-feeding, or whether to abstain from sugammadex therapy, considering the benefit of breast-feeding to the baby and the benefit of Bridion to the mother.
Ved brug af de anbefalede doser for rutinemæssig revertering vil mediantiden for revertering af T4/T1 ratioen til 0,9 være en smule kortere for rocuroniuminduceret neuromuskulær blokade sammenlignet med vecuroniuminduceret neuromuskulær blokade (se pkt.
Using the recommended doses for routine reversal will result in a slightly faster median time to recovery of the T4/T1 ratio to 0.9 of rocuronium when compared to vecuronium induced neuromuscular blockade (see section 5.1).
Du vil få Bridion af en anæstesilæge eller under overvågning af anæstesilægen.
Bridion will be given to you by your anaesthetist, or under the care of your anaesthetist.
Efter første åbning og fortynding opbevares i køleskab (2 °C - 8 °C) og skal anvendes inden for 24 timer.
After first opening and dilution, store at 2 to 8°C and use within 24 hours.
Det skal du vide, før du får Bridion
What you need to know before Bridion is given
I in vitro forsøg bemærkede man en farmakodynamisk interaktion (aPTT og PT forlængelse) med vitamin K antagonister, ufraktioneret heparin, heparinoider med lav molekylevægt, rivaroxaban og dabigatran (se pkt.
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).
Det anbefales at monitorere ophævelsen af den neuromuskulære blokade med en passende neuromuskulær monitoreringsteknik (se pkt.
The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade (see section 4.4).
• hvis du har eller har haft nyresygdomme.
• if you have kidney disease or had in the past.
Lægemiddeloverfølsomhedsreaktioner (se pkt.
Drug hypersensitivity reactions (see section 4.4)
Der foreligger ikke kliniske data om eksponering for sugammadex under graviditet.
For sugammadex no clinical data on exposed pregnancies are available.
Cisatracurium og neostigmin (50 µg/kg)
Cis-atracurium and neostigmine (50 mcg/kg)
EXP Opbevares ved 2-8 °C efter anbrud og fortynding og skal anvendes inden for 24 timer.
EXP After first opening and dilution, store at 2-8°C and use within 24 hours.
Der anbefales samme dosering som til voksne, selvom genopvågningstiderne hos ældre er tilbøjelige til at være længere (se pkt.
Even though the recovery times in elderly tend to be slower, the same dose recommendation as for adults should be followed (see section 4.4).
4.4 Let anæstesi.
See section 4.4 light anaesthesia.
T4/ T1 til 0,7
T4/T1 to 0.7
Moderat 29 27 (22) Svært
Moderate 29 27 (22) Severe 10 8 (21)
Efter den sidste dosis rocuronium eller vecuronium, ved 1-2 PTC, blev 4 mg/kg sugammadex eller 70 µg/kg neostigmin administreret i randomiseret orden.
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.
Indehaver af markedsføringstilladelsen Merck Sharp & Dohme B.V.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Merck Sharp & Dohme B.V.
Ved genetablering af T2 blev en dosis på 2 mg/kg sugammadex eller 50 µg/kg neostigmin administreret.
At the reappearance of T2 a dose of 2 mg/kg sugammadex or 50 mcg/kg neostigmine was administered.
For gen-administration af sugammadex se pkt.
For re-administration of sugammadex see section 4.2.
Tiden fra begyndelsen af administrationen af sugammadex eller neostigmin til revertering af T4/ T1 ratioen til 0,9 var:
The time from start of administration of sugammadex or neostigmine to recovery of the T4/T1 ratio to 0.9 was:
I et studie med frivillige resulterede doser på 4 mg/kg og 16 mg/kg sugammadex i maksimale gennemsnitlige forlængelser af aktiveret partiel tromboplastintid (aPTT) på henholdsvis 17 og 22% og af protrombintid (PT)[INR] på henholdsvis 11 og 22%.
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.
T4/ T1 til 0,8
T4/T1 to 0.8
Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
If you get any side effects, talk to your anaesthetist or other doctor.
Trafik- og arbejdssikkerhed Bridion påvirker ikke evnen til at køre bil og arbejde med maskiner.
Driving and using machines Bridion has no known influence on your ability to drive and use machines.
Disse farmakodynamiske interaktioner er ikke klinisk relevante hos patienter, der får rutine postoperativ profylaktisk antikoagulans.
In patients receiving routine post-operative prophylactic anticoagulation this pharmacodynamic interaction is not clinically relevant.
T4/ T1 til 0,9
T4/T1 to 0.9
Revertering med sugammadex af den neuromuskulære blokade induceret af rocuronium blev sammenlignet med reverteringen med neostigmin af den neuromuskulære blokade induceret af cisatracurium.
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.
Behandlingskomplikationer
Procedural complication
4.2 for opvågningstiden hos ældre) eller ødematøs tilstand (f.eks. svært nedsat leverfunktion), kan medføre længere opvågningstider.
Conditions associated with prolonged circulation time such as cardiovascular disease, old age (see section 4.2 for the time to recovery in elderly), or oedematous state (e.g., severe hepatic impairment) may be associated with longer recovery times.
Moderat 30 31 (23) Svært
Moderate 30 31 (23) Severe 10 9 (22)
Neuromuskulært blokerende stoffer og dosis, der skal administreres
NMBA and dose to be administered
Det er uvist, hvorvidt sugammadex udskilles i human mælk.
It is unknown whether sugammadex is excreted in human breast milk.
Anvendelse af sugammadex anbefales ikke til patienter med svært nedsat nyrefunktion, herunder dialysekrævende patienter (se pkt.
Sugammadex is not recommended for use in patients with severe renal impairment, including those requiring dialysis (see section 5.1).
Sugammadex gav en hurtigere revertering af den neuromuskulære blokade induceret af rocuronium sammenlignet med revertering med neostigmin af den neuromuskulære blokade induceret af cisatracurium:
Sugammadex provided faster reversal of neuromuscular blockade induced by rocuronium compared to neostigmine reversal of neuromuscular blockade induced by cis-atracurium:
Der er ikke set nogen kliniske relevante forskelle i de farmakokinetiske parametre i et studie med raske japanske og kaukasiske patienter.
In a study in healthy Japanese and Caucasian subjects no clinically relevant differences in pharmacokinetic parameters were observed.
I kliniske studier med forsøgspersoner behandlet med rocuronium eller vecuronium, hvor sugammadex blev administreret med en dosis tilpasset dybden af den neuromuskulære blokade, blev der observeret tilbagevenden af neuromuskulær blokade med en incidens på 0,20% baseret på neuromuskulær monitorering eller klinisk evidens.
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.
Bridion 100 mg/ml injektionsvæske, opløsning
Bridion 100 mg/mL solution for injection
Mediantiden for revertering af T4/T1 ratioen til 0,9 er ca. 2 minutter (se pkt.
Median time to recovery of the T4/T1 ratio to 0.9 is around 2 minutes (see section 5.1).
Sugammadex kan anvendes til revertering af forskellige grader af neuromuskulær blokade, der er induceret af rocuronium eller vecuronium:
Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade:
Mediantiden for revertering af T4/T1 ratioen til 0,9 er ca. 3 minutter (se pkt.
Median time to recovery of the T4/T1 ratio to 0.9 is around 3 minutes (see section 5.1).
• Spørg din anæstesilæge eller læge, hvis der er mere, du vil vide.
• If you have further questions, ask your anaesthetist or doctor.
Gen-administration af rocuronium eller vecuronium efter sugammadex: Angående ventetider for gen-administration af rocuronium eller vecuronium efter revertering med sugammadex se pkt.
Re-administration of rocuronium or vecuronium after sugammadex: For waiting times for re-administration of rocuronium or vecuronium after reversal with sugammadex, see section 4.4.
Luftvejskomplikationer forårsaget af anæstesi
Airway complication of anaesthesia