FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: The use of sugammadex in patients with severe renal impairment (including patients requiring dialysis (CrCl < 30 mL/min)) is not recommended (see section 4.4).
Danish: Brug af sugammadex anbefales ikke til patienter med svært nedsat nyrefunktion (inklusive patienter med behov for dialyse (CrCl < 30 ml/min)) (se pkt.
English: In obese patients, the dose of sugammadex should be based on actual body weight.
Danish: Ved dosering til overvægtige patienter bør dosis af sugammadex fastsættes i forhold til patientens faktiske kropsvægt.
English: • if you have liver disease or have had it in the past.
Danish: • hvis du har eller har haft en leversygdom.
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).
Danish: 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).
English: Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL.
Danish: Pakningsstørrelser: 10 hætteglas af 2 ml eller 10 hætteglas af 5 ml.
English: There was a single case of adjudicated anaphylaxis after the first dose of sugammadex 16 mg/kg (incidence 0.7%).
Danish: Der var et enkelt tilfælde af adjudikeret anafylaksi efter første dosis sugammadex 16 mg/kg (incidens 0,7%).
English: Clear and colourless to slightly yellow solution.
Danish: Klar, farveløs til let gullig opløsning.
English: The onset of a depolarizing neuromuscular blocking agent might be slower than expected, because a substantial fraction of postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent.
Danish: 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.
English: Due to the administration of certain medicinal products after sugammadex, theoretically rocuronium or vecuronium could be displaced from sugammadex.
Danish: Administrationen af visse lægemidler efter sugammadex kan teoretisk set fortrænge rocuronium eller vecuronium fra sugammadex.
English: Bridion contains the active substance sugammadex.
Danish: Bridion indeholder det aktive stof sugammadex.
English: 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.
Danish: 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.
English: For storage conditions of the diluted medicinal product, see section 6.3.
Danish: Opbevaringsforhold for det fortyndede lægemiddel se pkt.
English: Sugammadex can be administered at several time points after administration of rocuronium or vecuronium bromide:
Danish: Sugammadex kan administreres på flere forskellige tidspunkter efter administration af rocuroniumeller vecuroniumbromid:
English: Procedural hypotension
Danish: Hypotension under indgrebet
English: Allergic reactions were reported more commonly in healthy, conscious volunteers
Danish: Alvorlige allergiske eller allergilignende reaktioner kan være livstruende Allergiske reaktioner blev rapporteret hyppigere hos raske frivillige ved bevidsthed
English: As a result recurrence of neuromuscular blockade might be observed.
Danish: Som resultat heraf kan tilbagevenden af neuromuskulær blokade opstå.
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.
Danish: 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.
English: Use for reversal of neuromuscular blocking agents other than rocuronium or vecuronium: Sugammadex should not be used to reverse block induced by nonsteroidal neuromuscular blocking agents such as succinylcholine or benzylisoquinolinium compounds.
Danish: 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.
English: Routine reversal - deep neuromuscular blockade:
Danish: Rutinemæssig revertering - dyb neuromuskulær blokade:
English: Waiting times for re-administration with neuromuscular blocking agents after reversal with sugammadex:
Danish: Ventetider for gen-administration af neuromuskulært blokerende stoffer efter revertering med sugammadex:
English: 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.
Danish: 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.
English: Child
Danish: Unge
English: Routine reversal - moderate neuromuscular blockade:
Danish: Rutinemæssig revertering - moderat neuromuskulær blokade:
English: The above mentioned interactions for adults and the warnings in section 4.4 should also be taken into account for the paediatric population.
Danish: De ovennævnte interaktioner for voksne og advarslerne i pkt.
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).
Danish: 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.
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.
Danish: 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%.
English: In a previous study of similar design, there were three adjudicated cases of anaphylaxis, all after sugammadex 16 mg/kg (incidence 2.0%).
Danish: I et tidligere studie med sammenligneligt design var der tre adjudikerede tilfælde af anafylaksi, alle efter sugammadex 16 mg/kg (incidens 2,0%).
English: What Bridion is and what it is used for What you need to know before Bridion is given How Bridion is given
Danish: Virkning og anvendelse Det skal du vide, før du får Bridion Sådan bliver du behandlet med Bridion Bivirkninger
English: These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide.
Danish: De kaldes muskelafslappende midler, rocuroniumbromid og vecuroniumbromid er eksempler på disse.
English: Pulmonary patients:
Danish: Lungepatienter:
English: It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma and thereby reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction.
Danish: 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.
English: Sugammadex concentrations were no longer detectable beyond 7 days post-dose in subjects with severe renal insufficiency.
Danish: Koncentrationer af sugammadex var ikke længere detekterbare 7 dage efter dosering hos forsøgspersoner med svært nedsat nyrefunktion.
English: Anaesthetic complication (see section 4.4)
Danish: Anæstesikomplikationer (se pkt.
English: Anaesthetic complication:
Danish: Anæstesikomplikation:
English: 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).
Danish: 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).
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.
Danish: I in vitro forsøg bemærkede man en farmakodynamisk interaktion (aPTT- og PT-forlængelse) med vitamin K-antagonister, ufraktioneret heparin, lavmolekylære heparinoider, rivaroxaban og dabigatran.
English: Drug hypersensitivity reactions:
Danish: Lægemiddeloverfølsomhedsreaktioner:
English: • using anticoagulants who receive a dose of 16 mg/kg sugammadex.
Danish: • i behandling med antikoagulantia, og som får 16 mg sugammadex/kg.
English: Solution for injection 10 vials
Danish: Injektionsvæske, opløsning 10 hætteglas
English: Procedural Complication:
Danish: Behandlingskomplikation:
English: 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.
Danish: 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.
English: 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.
Danish: Anæstesilægen vil overvåge din tilstand nøje, og du vil derfor næppe få for meget Bridion.
English: Animal studies have shown excretion of sugammadex in breast milk.
Danish: Dyrestudier har vist, at sugammadex udskilles i modermælken.
English: 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.
Danish: 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.
English: Other ingredients: hydrochloric acid 3.7% and/or sodium hydroxide (to adjust pH), water for injections.
Danish: Andre hjælpestoffer: saltsyre 3,7% og/eller natriumhydroxid (til pH justering), vand til injektionsvæsker.
English: Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.
Danish: Revertering af neuromuskulær blokade induceret af rocuronium eller vecuronium hos voksne.
English: What Bridion looks like and contents of the pack Bridion is a clear and colourless to slightly yellow solution for injection.
Danish: Bridion er en klar og farveløs til svagt gul opløsning til indsprøjtning.
English: This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.
Danish: Dette resulterer i en revertering af den neuromuskulære blokade induceret af rocuronium eller vecuronium.
English: Recurrence of neuromuscular blockade:
Danish: Tilbagevenden af neuromuskulær blokade:
English: In case hepatic impairment is accompanied by coagulopathy see the information on the effect on haemostasis.
Danish: Hvis nedsat leverfunktion ledsages af koagulopati, se informationen vedr.
English: Time (minutes) from administration of rocuronium and sugammadex or succinylcholine to recovery of the T1 10%
Danish: Tiden (minutter) fra administration af rocuronium og sugammadex eller succinylcholin ved genetablering af T1 10%
English: Caution should be exercised when considering the use of sugammadex in patients with severe hepatic impairment or when hepatic impairment is accompanied by coagulopathy (see section 4.4).
Danish: 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.
English: 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.
Danish: 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.
English: 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).
Danish: 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.
English: Bridion will be given to you by your anaesthetist, or under the care of your anaesthetist.
Danish: Du vil få Bridion af en anæstesilæge eller under overvågning af anæstesilægen.
English: After first opening and dilution, store at 2 to 8°C and use within 24 hours.
Danish: Efter første åbning og fortynding opbevares i køleskab (2 °C - 8 °C) og skal anvendes inden for 24 timer.
English: What you need to know before Bridion is given
Danish: Det skal du vide, før du får Bridion
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).
Danish: 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.
English: The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade (see section 4.4).
Danish: Det anbefales at monitorere ophævelsen af den neuromuskulære blokade med en passende neuromuskulær monitoreringsteknik (se pkt.
English: • if you have kidney disease or had in the past.
Danish: • hvis du har eller har haft nyresygdomme.
English: Drug hypersensitivity reactions (see section 4.4)
Danish: Lægemiddeloverfølsomhedsreaktioner (se pkt.
English: For sugammadex no clinical data on exposed pregnancies are available.
Danish: Der foreligger ikke kliniske data om eksponering for sugammadex under graviditet.
English: Cis-atracurium and neostigmine (50 mcg/kg)
Danish: Cisatracurium og neostigmin (50 µg/kg)
English: EXP After first opening and dilution, store at 2-8°C and use within 24 hours.
Danish: EXP Opbevares ved 2-8 °C efter anbrud og fortynding og skal anvendes inden for 24 timer.
English: 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).
Danish: Der anbefales samme dosering som til voksne, selvom genopvågningstiderne hos ældre er tilbøjelige til at være længere (se pkt.
English: See section 4.4 light anaesthesia.
Danish: 4.4 Let anæstesi.
English: T4/T1 to 0.7
Danish: T4/ T1 til 0,7
English: Moderate 29 27 (22) Severe 10 8 (21)
Danish: Moderat 29 27 (22) Svært
English: After the last dose of rocuronium or vecuronium, at 1-2 PTCs, 4 mg/kg sugammadex or 70 mcg/kg neostigmine was administered in a randomised order.
Danish: 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.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Merck Sharp & Dohme B.V.
Danish: Indehaver af markedsføringstilladelsen Merck Sharp & Dohme B.V.
English: At the reappearance of T2 a dose of 2 mg/kg sugammadex or 50 mcg/kg neostigmine was administered.
Danish: Ved genetablering af T2 blev en dosis på 2 mg/kg sugammadex eller 50 µg/kg neostigmin administreret.
English: For re-administration of sugammadex see section 4.2.
Danish: For gen-administration af sugammadex se pkt.
English: The time from start of administration of sugammadex or neostigmine to recovery of the T4/T1 ratio to 0.9 was:
Danish: Tiden fra begyndelsen af administrationen af sugammadex eller neostigmin til revertering af T4/ T1 ratioen til 0,9 var:
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.
Danish: 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%.
English: T4/T1 to 0.8
Danish: T4/ T1 til 0,8
English: If you get any side effects, talk to your anaesthetist or other doctor.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Driving and using machines Bridion has no known influence on your ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Bridion påvirker ikke evnen til at køre bil og arbejde med maskiner.
English: In patients receiving routine post-operative prophylactic anticoagulation this pharmacodynamic interaction is not clinically relevant.
Danish: Disse farmakodynamiske interaktioner er ikke klinisk relevante hos patienter, der får rutine postoperativ profylaktisk antikoagulans.
English: T4/T1 to 0.9
Danish: T4/ T1 til 0,9
English: 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.
Danish: Revertering med sugammadex af den neuromuskulære blokade induceret af rocuronium blev sammenlignet med reverteringen med neostigmin af den neuromuskulære blokade induceret af cisatracurium.
English: Procedural complication
Danish: Behandlingskomplikationer
English: 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.
Danish: 4.2 for opvågningstiden hos ældre) eller ødematøs tilstand (f.eks. svært nedsat leverfunktion), kan medføre længere opvågningstider.
English: Moderate 30 31 (23) Severe 10 9 (22)
Danish: Moderat 30 31 (23) Svært
English: NMBA and dose to be administered
Danish: Neuromuskulært blokerende stoffer og dosis, der skal administreres
English: It is unknown whether sugammadex is excreted in human breast milk.
Danish: Det er uvist, hvorvidt sugammadex udskilles i human mælk.
English: Sugammadex is not recommended for use in patients with severe renal impairment, including those requiring dialysis (see section 5.1).
Danish: Anvendelse af sugammadex anbefales ikke til patienter med svært nedsat nyrefunktion, herunder dialysekrævende patienter (se pkt.
English: Sugammadex provided faster reversal of neuromuscular blockade induced by rocuronium compared to neostigmine reversal of neuromuscular blockade induced by cis-atracurium:
Danish: Sugammadex gav en hurtigere revertering af den neuromuskulære blokade induceret af rocuronium sammenlignet med revertering med neostigmin af den neuromuskulære blokade induceret af cisatracurium:
English: In a study in healthy Japanese and Caucasian subjects no clinically relevant differences in pharmacokinetic parameters were observed.
Danish: Der er ikke set nogen kliniske relevante forskelle i de farmakokinetiske parametre i et studie med raske japanske og kaukasiske patienter.
English: United Kingdom Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
Danish: Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
English: In clinical studies with subjects treated with rocuronium or vecuronium, where sugammadex was administered using a dose labelled for the depth of neuromuscular blockade, an incidence of 0.20% was observed for recurrence of neuromuscular blockade as based on neuromuscular monitoring or clinical evidence.
Danish: 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.
English: Bridion 100 mg/mL solution for injection
Danish: Bridion 100 mg/ml injektionsvæske, opløsning
English: Median time to recovery of the T4/T1 ratio to 0.9 is around 2 minutes (see section 5.1).
Danish: Mediantiden for revertering af T4/T1 ratioen til 0,9 er ca. 2 minutter (se pkt.
English: Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade:
Danish: Sugammadex kan anvendes til revertering af forskellige grader af neuromuskulær blokade, der er induceret af rocuronium eller vecuronium:
English: Median time to recovery of the T4/T1 ratio to 0.9 is around 3 minutes (see section 5.1).
Danish: Mediantiden for revertering af T4/T1 ratioen til 0,9 er ca. 3 minutter (se pkt.
English: • If you have further questions, ask your anaesthetist or doctor.
Danish: • Spørg din anæstesilæge eller læge, hvis der er mere, du vil vide.
English: 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.
Danish: Gen-administration af rocuronium eller vecuronium efter sugammadex: Angående ventetider for gen-administration af rocuronium eller vecuronium efter revertering med sugammadex se pkt.
English: Airway complication of anaesthesia
Danish: Luftvejskomplikationer forårsaget af anæstesi
English: In clinical studies with subjects treated with rocuronium or vecuronium, where sugammadex was administered using a dose labelled for the depth of neuromuscular blockade (N=2,022), an incidence of 0.20% was observed for recurrence of neuromuscular blockade as based on neuromuscular monitoring or clinical evidence (see section 4.4).
Danish: I kliniske studier med forsøgspersoner behandlet med rocuronium eller vecuronium, hvor sugammadex blev administreret med en dosis tilpasset dybden af den neuromuskulære blokade (N=2.022), blev der observeret tilbagevenden af neuromuskulær blokade med en incidens på 0,20% baseret på neuromuskulær monitorering eller klinisk evidens (se pkt.
English: 75 yrs
Danish: 75 år