FrancophonIA/ELRC3.0 huggingface dataset:
English: The causality of adverse events is therefore difficult to assess.
Danish: Den kausale sammenhæng mellem bivirkninger og lægemiddel er derfor vanskelig at vurdere.
English: Selected patient characteristics
Danish: Udvalgte patientkarakteristika
English: In the Pooled Phase 1 database, AEs considered common (≥ 1/100 to < 1/10) or very common (≥ 1/10) and more frequent among subjects treated with sugammadex than in the placebo group, include dysgeusia (10.1%), headache (6.7%), nausea (5.6%), urticaria (1.7%), pruritus (1.7%), dizziness (1.6%), vomiting (1.2%) and abdominal pain (1.0%).
Danish: I den puljede fase-1 database var de bivirkninger, som blev anset for at være almindelige (≥1/100 til <1/10) eller meget almindelige (≥1/10) og hyppigere hos forsøgspersoner, der blev behandlet med sugammadex end i placebogruppen, følgende: dysgeusi (10,1%), hovedpine (6,7%), kvalme (5,6%), urticaria (1,7%), pruritus (1,7%), svimmelhed (1,6%), opkastning (1,2%) og abdominalsmerter (1,0%).
English: Interactions due to the lasting effect of rocuronium or vecuronium:
Danish: Interaktioner pga. vedvarende effekt af rocuronium eller vecuronium:
English: For toremifene and fusidic acid displacement interactions could not be excluded (no clinically relevant capturing interactions are expected).
Danish: For toremifen og fusidinsyre kan fortrængnings-interaktioner ikke udelukkes (der forventes ingen klinisk relevante bindings-interaktioner).
English: If neuromuscular blockade is required before the recommended waiting time has passed, a nonsteroidal neuromuscular blocking agent should be used.
Danish: Hvis neuromuskulær blokade er påkrævet før den anbefalede ventetid er gået, bør et non-steroidt neuromuskulært blokerende stof anvendes.
English: For hormonal contraceptives a clinically relevant capturing interaction could not be excluded (no displacement interactions are expected).
Danish: For hormonelle præventionsmidler kan klinisk relevante bindings-interaktioner ikke udelukkes (der forventes ingen fortrængnings-interaktioner).
English: You should not be given Bridion
Danish: Du må ikke få Bridion
English: 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium
Danish: 0,6 mg/kg rocuronium eller 0,1 mg/kg vecuronium
English: The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments, clinical studies and simulations using a model taking into account the pharmacodynamic effect of neuromuscular blocking agents and the pharmacokinetic interaction between neuromuscular blocking agents and sugammadex.
Danish: Informationen i dette afsnit er baseret på bindingsaffinitet mellem sugammadex og andre lægemidler, ikke-kliniske eksperimenter, kliniske studier og simuleringer, hvor der anvendes en model, der tager højde for den farmokodynamiske effekt af neuromuskulære blokkere og den farmakokinetiske interaktion mellem neuromuskulære blokkere og sugammadex.
English: The bolus injection should be given rapidly, within 10 seconds, into an existing intravenous line (see section 6.6).
Danish: Bolusinjektionen bør gives hurtigt, inden for 10 sekunder, i et eksisterende i.v.
English: The use of fusidic acid in the pre-operative phase may give some delay in the recovery of the T4/T1 ratio to 0.9.
Danish: Anvendelse af fusidinsyre i den præoperative fase kan forårsage nogen forsinkelse af revertering af T4/T1 ratioen til 0,9.
English: There were no reports of anaphylaxis after placebo or sugammadex 4 mg/kg.
Danish: Der var ingen indberetninger om anafylaksi efter placebo eller sugammadex 4 mg/kg.
English: In situations when potential displacement interactions can be anticipated, patients should be carefully monitored for signs of recurrence of neuromuscular blockade (approximately up to 15 minutes) after parenteral administration of another medicinal product occurring within a period of 7.5 hours after sugammadex administration.
Danish: I situationer hvor potentielle fortrængnings interaktioner kan forventes, bør patienter monitoreres tæt for tegn på tilbagevenden af neuromuskulærblokade (ca. 15 minutter) efter parenteral administration af et andet lægemiddel, som gives i op til 7,5 timer efter sugammadex.
English: After administration of sugammadex at reappearance of T2 following a rocuronium induced blockade, the median time to recovery of the T4/T1 ratio to 0.9 in adults (18-64 years) was 2.2 minutes, in elderly adults (65-74 years) it was 2.6 minutes and in very elderly adults (75 years or more) it was 3.6 minutes.
Danish: Efter indgivelse af sugammadex, ved genetablering af T2 efter en rocuroniuminduceret blokade, var mediantiden for revertering af T4/T1 ratioen til 0,9 hos voksne (18-64 år) 2,2 minutter, hos gamle patienter (65-74 år) var den 2,6 minutter, og hos ældre patienter (75 år eller mere) var den 3,6 minutter.
English: There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade.
Danish: Der er ingen data, der understøtter brugen af sugammadex til øjeblikkelig revertering efter vecuroniuminduceret blokade.
English: Bridion 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%).
Danish: Bridion kan injiceres i intravenøse infusionsslanger med følgende infusionsvæsker: natriumchlorid 9 mg/ml (0,9%), glucose 50 mg/ml (5%), natriumchlorid 4,5 mg/ml (0,45%) og glucose 25 mg/ml (2,5%), Ringer-lactat, Ringer og glucose 50 mg/ml (5%) i natriumchlorid 9 mg/ml (0,9%).
English: • if you have diseases which are known to give an increased risk of bleeding (disturbances of blood clotting) or anticoagulation medication.
Danish: • hvis du har en sygdom, som er kendt for at øge blødningsrisikoen (give forstyrrelser i blodkoagulationen), eller hvis du tager medicin, som nedsætter blodets evne til at størkne
English: 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.
Danish: Farmakokinetiske parametre som clearance og distributionsvolumen antages at være de samme for nonkompleksbundet og kompleksbundet sugammadex i bedøvede patienter.
English: Recovery from blockade was modestly longer for patients with severe renal impairment relative to patients without renal impairment.
Danish: Ophævelse af blokaden tog moderat længere tid hos patienter med svært nedsat nyrefunktion sammenlignet med patienter uden nedsat nyrefunktion.
English: For mild and moderate renal impairment (creatinine clearance ≥ 30 and < 80 mL/min): the dose recommendations are the same as for adults without renal impairment.
Danish: Ved let til moderat nedsat nyrefunktion (kreatininclearance (CrCl) ≥ 30 og < 80 ml/min): Der anbefales samme dosis som til voksne uden nedsat nyrefunktion.
English: In case recurrence of neuromuscular blockade is observed, the patient may require mechanical ventilation and re-administration of sugammadex (see section 4.2).
Danish: I tilfælde af tilbagevenden af neuromuskulær blokade kan patienten få behov for mekanisk ventilering og gen-administration af sugammadex (se pkt.
English: As with all patients with a history of pulmonary complications the physician should be aware of the possible occurrence of bronchospasm.
Danish: For alle patienter med lungekomplikationer i anamnesen bør lægen være opmærksom på muligheden for forekomst af bronkospasmer.
English: Low concentrations of sugammadex are detectable for at least 48 hours post-dose in patients with severe renal insufficiency.
Danish: Lave koncentrationer af sugammadex er sporbare i mindst 48 timer efter dosering hos patienter med alvorlig nyreinsufficiens.
English: In rare instances, marked bradycardia has been observed within minutes after the administration of sugammadex for reversal of neuromuscular blockade.
Danish: I sjældne tilfælde er der set udtalt bradykardi inden for få minutter efter administration af sugammadex til revertering af neuromuskulær blokade.
English: - The other ingredients are water for injections, hydrochloric acid 3.7% and/or sodium hydroxide.
Danish: - Øvrige indholdsstoffer: vand til injektionsvæsker, saltsyre 3,7% og/eller natriumhydroxid.
English: Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade.
Danish: Patienterne skal monitoreres tæt for hæmodynamiske forandringer under og efter revertering af neuromuskulær blokade.
English: Neither sugammadex nor the complex of sugammadex and rocuronium binds to plasma proteins or erythrocytes, as was shown in vitro using male human plasma and whole blood.
Danish: Hverken sugammadex eller komplekset af sugammadex og rocuronium binder til plasmaproteiner eller erytrocytter, som blev vist in vitro med hankønsplasma og fuldblod.
English: If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended.
Danish: Hvis der er klinisk behov for øjeblikkelig revertering efter indgivelse af rocuronium, anbefales en dosis på 16 mg/kg sugammadex.
English: Frequencies
Danish: Hyppighed
English: In a pharmacokinetic study comparing patients with severe renal impairment to patients with normal renal function, sugammadex levels in plasma were similar during the first hour after dosing, and thereafter the levels decreased faster in the control group.
Danish: I et farmakokinetisk studie, der sammenlignede patienter med svært nedsat nyrefunktion med patienter med normal nyrefunktion, var sugammadex-niveauerne i plasma ens i den første time efter dosering, og derefter faldt niveauerne hurtigst i kontrolgruppen.
English: • Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in patients with a history of lung problems
Danish: • Kortåndethed som følge af muskelkramper i luftvejene (bronkospasmer) opstod hos patienter, der har eller har haft lungeproblemer
English: The use of lower than recommended doses may lead to an increased risk of recurrence of neuromuscular blockade after initial reversal and is not recommended (see section 4.2 and section 4.8).
Danish: Brug af lavere doser end anbefalet kan føre til øget risiko for tilbagevenden af neuromuskulær blokade efter initial revertering og anbefales ikke (se pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Bridion findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Based on the clinical data-base (N=3,519) and on a specific study in 1184 patients undergoing hip fracture/major joint replacement surgery there was no clinically relevant effect of sugammadex 4 mg/kg alone or in combination with anticoagulants on the incidence of peri- or post-operative bleeding complications.
Danish: Baseret på den kliniske database (N=3.519) og på et specifikt studie med 1.184 patienter, der havde gennemgået operation for hoftefraktur/udskiftning af større led var der ingen klinisk relevant effekt på forekomsten af peri- eller postoperative blødningskomplikationer af sugammadex 4 mg/kg alene eller i kombination med antikoagulantia.
English: Symptoms associated with these reactions can include: flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia, swelling of tongue, swelling of pharynx, bronchospasm and pulmonary obstructive events.
Danish: Symptomer, der er associeret med disse reaktioner kan være: rødmen, urticaria, erytematøs udslæt, (alvorlig) hypotension, takykardi, opsvulmet tunge, hævelse i svælget, bronkospasme og pulmonale obstruktive hændelser.
English: In adult anaesthetized patients with normal renal function the elimination half-life (t1/2) of sugammadex is about 2 hours and the estimated plasma clearance is about 88 mL/min.
Danish: Hos voksne narkosepatienter med normal nyrefunktion er sugammadex' eliminationshalveringstid (t1/2) omkring 2 timer og den estimerede plasma-clearance omkring 88 ml/min.
English: Procedural complications included coughing, tachycardia, bradycardia, movement, and increase in heart rate.
Danish: Behandlingskomplikationer inkluderede hoste, takykardi, bradykardi, bevægelse og øget hjertefrekvens.
English: Exposure was 2-fold and 5-fold higher in subjects with moderate and severe renal impairment, respectively.
Danish: Eksponeringen var henholdsvis 2 og 5 gange højere hos forsøgspersoner med moderat og svært nedsat nyrefunktion.
English: For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required.
Danish: Ved mild til moderat nedsat leverfunktion: da sugammadex hovedsageligt udskilles via nyrerne er dosisjustering ikke nødvendig.
English: 2 mL or 5 mL of solution in type I glass vial closed with chlorobutyl rubber stoppers with aluminium crimp-cap and flip-off seal.
Danish: 2 ml eller 5 ml opløsning i type I glas, hætteglas, lukket med chlorobutyl gummiprop med aluminiumslåg og aftagelig forsegling.
English: Re-administration of rocuronium or vecuronium after immediate reversal (16 mg/kg sugammadex): For the very rare cases where this might be required, a waiting time of 24 hours is suggested.
Danish: Gen-administration af rocuronium eller vecuronium efter øjeblikkelig revertering (16 mg/kg sugammadex): i de meget sjældne tilfælde, hvor dette er påkrævet, anbefales en ventetid på 24 timer.
English: Please refer to the package leaflet of rocuronium or vecuronium for a list of the specific medicinal products which potentiate neuromuscular blockade.
Danish: Se venligst indlægssedlen for rocuronium eller vecuronium, hvor der findes en liste over de lægemidler, som potenserer neuromuskulær blokade.
English: Each mL solution contains up to 9.7 mg sodium.
Danish: En ml opløsning indeholder op til 9,7 mg natrium.
English: It comes in two different pack sizes, containing either 10 vials with 2 mL or 10 vials with 5 mL solution for injection.
Danish: Den findes i to forskellige pakningsstørrelser, der indeholder enten 10 hætteglas med 2 ml eller 10 hætteglas med 5 ml injektionsvæske.
English: Sugammadex exhibits linear kinetics in the dosage range of 1 to 16 mg/kg when administered as an IV bolus dose.
Danish: Sugammadex udviser lineær kinetik i dosisintervallet 1 til 16 mg/kg, når det administreres som en i.v.-bolusdosis.
English: Bridion is considered to be a Selective Relaxant Binding Agent since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.
Danish: Bridion er en Selektiv Relaksantia Antidot, da det kun virker sammen med specifikke muskelafslappende midler, rocuroniumbromid eller vecuroniumbromid.
English: It does this by combining with the rocuronium bromide or vecuronium bromide in your body.
Danish: Det gør det ved at binde sig til rocuroniumbromid eller vecuroniumbromid i kroppen.
English: Succinylcholine (1 mg/kg)
Danish: Succinylcholin (1 mg/kg)
English: No residual neuromuscular blockade or recurrence of neuromuscular blockade was reported for patients with severe renal impairment in these studies.
Danish: Der blev ikke rapporteret om tilbageværende eller tilbagevendende neuromuskulær blokade hos patienter med svært nedsat nyrefunktion i disse studier.
English: 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.
Danish: Hvis sugammadex administreres samme dag som et oralt præventionsmiddel indtages, bør man følge de råd, der er givet vedrørende glemte tabletter i indlægssedlen for det orale præventionsmiddel.
English: Sugammadex should be administered intravenously as a single bolus injection.
Danish: Sugammadex bør administreres intravenøst som en enkelt bolusinjektion.
English: In a pooled analysis the following recovery times for 16 mg/kg sugammadex after 1.2 mg/kg rocuronium bromide were reported:
Danish: I en samlet analyse blev følgende reverteringstider for 16 mg/kg sugammadex efter 1,2 mg/kg rocuroniumbromid rapporteret:
English: Re-administration of rocuronium or vecuronium after routine reversal (up to 4 mg/kg sugammadex):
Danish: Gen-administration af rocuronium eller vecuronium efter rutinemæssig revertering (op til 4 mg/kg sugammadex):
English: A summary of sugammadex pharmacokinetic parameters stratified by age and renal function is presented below:
Danish: En oversigt over de farmakokinetiske (PK) parametre for sugammadex, stratificeret ud fra alder og nyrefunktion, er vist nedenfor:
English: The onset of neuromuscular blockade may be prolonged up to approximately 4 minutes, and the duration of neuromuscular blockade may be shortened up to approximately 15 minutes after readministration of rocuronium 1.2 mg/kg within 30 minutes after sugammadex administration.
Danish: Indtræden af den neuromuskulære blokade kan forlænges op til ca. 4 minutter, og varigheden af den neuromuskulære blokade kan forkortes ca. 15 minutter efter gen-administration af rocuronium 1,2 mg/kg inden for 30 minutter efter administration af sugammadex.
English: Studies in patients with hepatic impairment have not been conducted.
Danish: Der er ikke udført studier hos patienter med nedsat leverfunktion.
English: A randomised, double-blind study examined the incidence of drug hypersensitivity reactions in healthy volunteers given up to 3 doses of placebo (N=76), sugammadex 4 mg/kg (N=151) or sugammadex 16 mg/kg (N=148).
Danish: Et randomiseret, dobbeltblindet studie undersøgte incidensen af lægemiddeloverfølsomhedsreaktioner hos raske frivillige, der havde fået op til 3 doser placebo (N=76), sugammadex 4 mg/kg (N=151) eller sugammadex 16 mg/kg (N=148).
English: Interference with this test is observed at sugammadex plasma concentrations of 100 microgram/mL (peak plasma level following 8 mg/kg bolus injection).
Danish: Påvirkning af denne test er blevet observeret ved sugammadex plasmakoncentrationer på 100 mikrogram/ml (Cmax efter en bolusinjektion på 8 mg/ml).
English: The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed.
Danish: Den anbefalede dosis af sugammadex afhænger af graden af den neuromuskulære blokade, der skal reverteres.
English: The amount of progestogen lost by using Bridion is about the same as missing one oral contraceptive Pill.
Danish: Den mængde progestogen, du mister ved anvendelsen af Bridion, svarer til at glemme en p-pille.
English: Sugammadex has been administered in doses ranging from 0.5 mg/kg to 16 mg/kg in dose response studies of rocuronium induced blockade (0.6, 0.9, 1.0 and 1.2 mg/kg rocuronium bromide with and without maintenance doses) and vecuronium induced blockade (0.1 mg/kg vecuronium bromide with or without maintenance doses) at different time points/depths of blockade.
Danish: Sugammadex er blevet administreret med doser fra 0,5 mg/kg til 16 mg/kg i dosis-respons studier af rocuroniuminduceret blokade (0,6; 0,9; 1,0 og 1,2 mg/kg rocuroniumbromid med og uden vedligeholdelsesdoser) og vecuroniuminduceret blokade (0,1 mg/kg vecuroniumbromid med og uden vedligeholdelsesdoser) på forskellige tidspunkter/dybder af blokaden.
English: When medicinal products which potentiate neuromuscular blockade are used in the post-operative period special attention should be paid to the possibility of recurrence of neuromuscular blockade.
Danish: Når lægemidler, der potenserer neuromuskulær blokade, anvendes postoperativt, skal man være særligt opmærksom på risikoen for tilbagevenden af neuromuskulær blokade.
English: For routine reversal of rocuronium induced blockade at reappearance of T2 in children and adolescents (2-17 years) 2 mg/kg sugammadex is recommended.
Danish: Til rutinemæssig revertering af tilbagevendelsen til T2 efter rocuroniuminduceret blokade hos børn og unge (2-17 år) anbefales 2 mg/kg sugammadex.
English: Neuromuscular blocking agent
Danish: Neuromuskulær blokker
English: 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.
Danish: Hvis der anvendes et ikke-oralt hormonalt præventionsmiddel skal patienten de efterfølgende 7 dage anvende et alternativt ikke-hormonelt præventionsmiddel og følge rådene i indlægssedlen.
English: In post-marketing, isolated cases of marked bradycardia and bradycardia with cardiac arrest have been observed within minutes after administration of sugammadex (see section 4.4).
Danish: Efter markedsføring er der set enkelte tilfælde af udtalt bradykardi og bradykardi med hjertestop inden for få minutter efter administration af sugammadex (se pkt.
English: The effects with sugammadex on human fertility have not been investigated.
Danish: Der er ikke foretaget undersøgelser af sugammadex' virkning på human fertilitet.
English: Discard any unused solution.
Danish: Ubrugt opløsning kasseres.
English: For paediatric patients Bridion can be diluted using sodium chloride 9 mg/mL (0.9%) to a concentration of 10 mg/mL (see section 6.3).
Danish: Til pædiatriske patienter kan Bridion fortyndes i natriumchlorid 9 mg/ml (0,9%) til en koncentration på 10 mg/ml (se pkt.
English: In a second study comparing subjects with moderate or severe renal impairment to subjects with normal renal function, sugammadex clearance progressively decreased and t1/2 was progressively prolonged with declining renal function.
Danish: I et andet studie, der sammenlignede forsøgspersoner med moderat eller svært nedsat nyrefunktion med forsøgspersoner med normal nyrefunktion, faldt sugammadex' clearance progressivt, og t1/2 blev forlænget gradvist med aftagende nyrefunktion.
English: In one study, sugammadex was administered following rocuronium induced blockade at 1-2 PTCs (4 mg/kg; N=68); in the other study, sugammadex was administered at reappearance of T2 (2 mg/kg; N=30).
Danish: 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).
English: Other medicines and Bridion → Tell your anaesthetist if you are taking, have recently taken or might take any other medicines.
Danish: 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.
English: Moderate 15 11 (22) Severe 5 3 (22)
Danish: Moderat 15 11 (22) Svært
English: Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections
Danish: Saltsyre 3,7% (til justering af pH) og/eller natriumhydroxid (til pH justering) Vand til injektionsvæsker
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Bridion på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Sugammadex has only been administered as a single bolus injection in clinical trials.
Danish: Sugammadex er kun administreret som en enkel bolusinjektion i kliniske forsøg.
English: 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.
Danish: 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.
English: Sugammadex has no effects on fracture repair and remodelling of bone.
Danish: Sugammadex har ingen effekt på heling af frakturer og remodellering af knoglevæv.
English: Caution should be exercised when considering the use of sugammadex in patients receiving therapeutic anticoagulation for a pre-existing or comorbid condition.
Danish: Der bør udvises forsigtighed, når sugammadex overvejes til patienter i behandling med terapeutiske antikoagulantia for en allerede eksisterende eller co-morbid tilstand.