FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and volunteers (for information on volunteers, see Information on healthy volunteers below).
Danish: Overfølsomhedsreaktioner, inklusive anafylaksi, er set hos nogle patienter og frivillige (for information om frivillige, se afsnittet Information om raske frivillige nedenfor).
English: Interference with laboratory tests:
Danish: Påvirkning af laboratorieundersøgelser:
English: Based upon clinical studies, sugammadex concentrations in plasma are reduced by up to 70% after a 3 to 6-hour dialysis session.
Danish: Baseret på kliniske studier reduceres sugammadex-koncentrationerne i plasma med op til 70% efter 3-6 timers dialyse.
English: Physical incompatibility has been reported with verapamil, ondansetron and ranitidine.
Danish: Fysisk uforligelighed er rapporteret med verapamil, ondansetron og ranitidin.
English: Limited data are available for reversal of pancuronium induced blockade, but it is advised not to use sugammadex in this situation.
Danish: Der findes begrænsede data for revertering af pancuroniuminduceret blokade, men det tilrådes ikke at anvende sugammadex i denne situation.
English: 5 minutes
Danish: 5 minutter
English: No recurrence of neuromuscular blockade is expected in the post-operative phase, since the infusion rate of fusidic acid is over a period of several hours and the blood levels are cumulative over 2-3 days.
Danish: Neuromuskulær blokade forventes ikke at genopstå i den postoperative fase, da infusionshastigheden af fusidinsyre er over en periode på flere timer, og blodniveauet er kumulativt over 2-3 dage.
English: The observed steady-state volume of distribution of sugammadex is approximately 11 to 14 litres in adult patients with normal renal function (based on conventional, non-compartmental pharmacokinetic analysis).
Danish: Sugammadex' observerede steady-state fordelingsvolumen er ca. 11-14 liter hos voksne patienter med normal nyrefunktion (baseret på konventionel, ikke-kompartmentel farmakokinetisk analyse).
English: Your anaesthetist will work out the dose of Bridion you need based on:
Danish: Anæstesilægen vil beregne den Bridion-dosis du skal have, baseret på:
English: Oral absorption of cyclodextrins in general is low and no effect on the suckling child is anticipated following a single dose to the breast-feeding woman.
Danish: Den orale absorption af cyclodextrin er generelt lav, og der forventes ingen effekt på ammede børn, som følge af administrationen af en enkelt dosis til ammende kvinder.
English: Median (minutes) Range
Danish: Median (minutter) Område
English: Immediate reversal in children and adolescents has not been investigated and is therefore not recommended until further data become available.
Danish: Øjeblikkelig revertering hos børn og unge er ikke blevet undersøgt og kan derfor ikke anbefales, før der foreligger yderligere data.
English: • Airway difficulties that may include coughing or moving as if you are waking or taking a breath
Danish: • Luftvejsproblemer som kan inkludere hoste eller bevægelser som kan tyde på, at du vågner eller tager en indånding
English: The safety of sugammadex has been evaluated in 3,519 unique subjects across a pooled phase I-III safety database.
Danish: Sikkerheden af sugammadex blev vurderet hos 3.519 individuelle forsøgspersoner i en sikkerhedsdatabase for puljede fase I-III-studier.
English: What Bridion is used for
Danish: Hvad Bridion bruges til
English: However, it may affect the results of a blood test for a hormone called progesterone.
Danish: Det kan dog påvirke resultatet af blodprøver for hormonet progesteron.
English: It is given as a single injection through an intravenous line.
Danish: Det gives som en enkelt indsprøjtning i en infusionsslange.
English: For this, the general anaesthetic you are given includes medicines to make your muscles relax.
Danish: Almindelige bedøvelsesmidler, du vil få til dette, inkluderer lægemidler, der får dine muskler til at slappe af.
English: It can be used in adults whenever rocuronium bromide or vecuronium bromide is used and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used for a moderate level of relaxation.
Danish: Det kan bruges hos voksne, når rocuroniumbromid eller vecuroniumbromid har været anvendt og hos børn og unge (i alderen 2 til 17 år), når rocuroniumbromid har været anvendt til at opnå et moderat afslapningsniveau.
English: After first opening and dilution chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 25°C.
Danish: Efter første åbning og fortynding er der vist kemisk og fysisk stabilitet i brug op til 48 timer ved 2 °C til 25 °C.
English: Bradycardia may occasionally lead to cardiac arrest.
Danish: Bradykardi kan af og til føre til hjertestop (se pkt.
English: For single use only.
Danish: Intravenøs anvendelse Kun til engangsbrug.
English: Intravenous administration of fusidic acid:
Danish: Intravenøs administration af fusidinsyre:
English: 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 daily dose of an oral contraceptive is taken 12 hours too late, which might lead to a reduction in effectiveness.
Danish: Interaktionen mellem 4 mg/kg sugammadex og et progestogen var forventet at føre til et fald i progestogeneksponeringen (34% af AUC) svarende til det fald, som ses, når en daglig dosis af et oralt præventionsmiddel tages 12 timer for sent, hvilket kan medføre reduceret effektivitet.
English: Even if recovery from neuromuscular blockade is complete, other medicinal products used in the peri- and postoperative period could depress respiratory function and therefore ventilatory support might still be required.
Danish: Selv om revertering af den neuromuskulære blokade er fuldstændig, kan andre lægemidler, som er anvendt i den peri- og postoperative periode, undertrykke den respiratoriske funktion, og derfor kan ventilering stadig være påkrævet.
English: Studies in patients with severe renal impairment do not provide sufficient safety information to support the use of sugammadex in these patients (see also section 5.1).
Danish: Studier med patienter med svært nedsat nyrefunktion giver ikke tilstrækkelig sikkerhedsinformation til at understøtte brugen af sugammadex hos disse patienter (se også pkt.
English: A limited database suggests that the safety profile of sugammadex (up to 4 mg/kg) in paediatric patients was similar to that in adults.
Danish: En begrænset database tyder på, at sikkerhedsprofilen for sugammadex (op til 4 mg/kg) hos pædiatriske patienter svarede til sikkerhedsprofilen for voksne.
English: Body weight:
Danish: Kropsvægt:
English: The data for the paediatric population are limited (one study only for reversal of rocuronium induced blockade at reappearance of T2).
Danish: Data for den pædiatriske population er begrænset (kun et studie for revertering af rocuroniuminduceret blokade ved genetablering af T2).
English: If a shorter waiting time is required, the rocuronium dose for a new neuromuscular blockade should be 1.2 mg/kg.
Danish: Hvis kortere ventetid er påkrævet, bør rocuroniumdosis til en ny neuromuskulær blokade være 1,2 mg/kg.
English: In clinical studies, 1 case of an accidental overdose with 40 mg/kg was reported without any significant adverse reactions.
Danish: I kliniske studier blev der rapporteret ét tilfælde af utilsigtet overdosering med 40 mg/kg uden signifikante bivirkninger.
English: • Allergic (drug hypersensitivity) reactions - such as a rash, red skin, swelling of your tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, sometimes resulting in a serious decrease of blood pressure.
Danish: • Allergiske reaktioner (lægemiddeloverfølsomhed) - såsom udslæt, rødmen, opsvulmet tunge og/eller svælg, stakåndethed, ændringer i blodtrykket eller hjerterytmen, der nogle gange bevirker et alvorligt fald i blodtrykket.
English: The following information is intended for healthcare professionals only: For detailed information refer to the Summary of Product Characteristics of BRIDION.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: For mere detaljerede oplysninger henvises til Produktresuméet for Bridion.
English: What Bridion is
Danish: Hvad Bridion er
English: 96% of the dose was excreted in urine, of which at least 95% could be attributed to unchanged sugammadex.
Danish: 96% af dosis blev udskilt i urinen, hvor 95% var uomdannet sugammadex.
English: Clinicians should be aware that 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.
Danish: Lægen skal være opmærksom på, at revertering af T4/T1 ratioen til 0,9 derfor kan være forsinket hos patienter, som har fået toremifen på operationsdagen.
English: In clinical trials of surgical patients these reactions were reported uncommonly and for post-marketing reports the frequency is unknown.
Danish: I kliniske studier med kirurgiske patienter blev disse reaktioner rapporteret som værende ikke almindelige og blev efter markedsføring rapporteret med en ukendt frekvens.
English: Additional information on special populations
Danish: Yderligere information om specielle populationer
English: Bridion can affect hormonal contraceptives
Danish: Bridion kan påvirke virkningen af hormonelle præventionsmidler
English: No dose related adverse events nor serious adverse events were reported.
Danish: Der blev ikke rapporteret om dosisrelaterede bivirkninger eller alvorlige bivirkninger.
English: 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.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, potentiel genotoksicitet, karcinogenicitet og reproduktionstoksicitet, lokal tolerance eller kompatibilitet med blod.
English: • if you have fluid retention (oedema).
Danish: • hvis du har væskeophobninger (ødemer).
English: Term newborn infants and infants:
Danish: Nyfødte og spædbørn:
English: Interactions potentially affecting the efficacy of sugammadex (displacement interactions):
Danish: Interaktioner, som muligvis påvirker effekten af sugammadex (fortrængnings-interaktioner):
English: • with hereditary vitamin K dependent clotting factor deficiencies;
Danish: • med arvelig mangel på vitamin K-afhængig koagulationsfaktor;
English: A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.
Danish: En dosis på 16 mg/kg kan anvendes hos voksne, hvis akut opvågnen fra den muskelafslappede tilstand er påkrævet.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og etiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Distribution:
Danish: Fordeling:
English: If there is a medical need to give sugammadex to these patients the anaesthesiologist needs to decide if the benefits outweigh the possible risk of bleeding complications taking into consideration the patients history of bleeding episodes and type of surgery scheduled.
Danish: Hvis der er medicinsk behov for at give sugammadex til disse patienter, skal anæstesiologen afgøre, om fordelene opvejer de mulige risici for blødningskomplikationer under hensyntagen til patientens tidligere blødningsepisoder, samt hvilken type operation der er planlagt.
English: For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.
Danish: For den pædiatriske population: sugammadex anbefales kun til rutinemæssig revertering af rocuronium-induceret blokade hos børn og unge i alderen 2 til 17 år.
English: In general sugammadex does not interfere with laboratory tests, with the possible exception of the serum progesterone assay.
Danish: I almindelighed påvirker sugammadex ikke laboratorieundersøgelser, dog med mulig undtagelse af serum-progesteronmåling.
English: • Decreased blood pressure due to the surgical procedure
Danish: • Et fald i blodtrykket som følge af operationen
English: Caution should be exercised when administering sugammadex to pregnant women.
Danish: Der bør udvises forsigtighed ved ordinering af sugammadex til gravide kvinder.
English: Two open label studies compared the efficacy and safety of sugammadex in surgical patients with and without severe renal impairment.
Danish: To åbne studier sammenlignede virkningen og sikkerheden af sugammadex hos kirurgiske patienter med og uden svært nedsat nyrefunktion.
English: These reactions varied from isolated skin reactions to serious systemic reactions (i.e. anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex.
Danish: Disse reaktioner varierede fra isolerede reaktioner på huden til alvorlige systemiske reaktioner (f.eks. anafylaksi, anafylaktisk chok) og forekom hos patienter, som ikke tidligere har været behandlet med sugammadex.
English: If neuromuscular blockade is reversed, while anaesthesia is continued, additional doses of anaesthetic and/or opioid should be given as clinically indicated.
Danish: Hvis neuromuskulær blokade reverterer mens anæstesien fortsættes, skal der gives yderligere doser anæsteticum og/eller opioid som klinisk indiceret.
English: Interactions potentially affecting the efficacy of other medicinal products (capturing interactions): Due to the administration of sugammadex, certain medicinal products could become less effective due to a lowering of the (free) plasma concentrations.
Danish: Interaktioner, som muligvis påvirker effekten af andre lægemidler (bindings-interaktioner): Samtidig administration af sugammadex, kan nedsætte effekten af visse lægemidler, da (de frie) plasmakoncentrationer nedsættes.
English: Talk to your anaesthetist before Bridion is given
Danish: Tal med din anæstesilæge, før du får Bridion
English: Bridion contains sodium Tell your anaesthetist if you are on a controlled salt diet.
Danish: Bridion indeholder natrium Fortæl det til anæstesilægen, hvis du er på en saltfattig diæt.
English: 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.
Danish: I prækliniske og kliniske studier er der ikke set sugammadex metabolitter, og der blev kun set renal udskillelse af det uomdannede produkt som eliminationsvej.
English: The infusion line should be adequately flushed (e.g., with 0.9% sodium chloride) between administration of Bridion and other drugs.
Danish: Infusionsslangen skal skylles grundigt (f.eks. med 0,9% natriumchlorid) mellem administration af Bridion og andre lægemidler.
English: There was no evidence of increased frequency or severity of hypersensitivity with repeat dosing of sugammadex.
Danish: Der var ikke evidens for øget hyppighed eller forværring af overfølsomhed ved gentagen dosering af sugammadex.
English: → If you are using other hormonal contraceptives (for example a vaginal ring, implant or IUS) you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the advice in the package leaflet.
Danish: → hvis du anvender andre hormonelle præventionsmidler (for eksempel vaginalring, implantat eller spiral) skal du anvende et ekstra ikke-hormonelt præventionsmiddel (såsom kondom) de næste 7 dage og følge vejledningen i indlægssedlen for præventionsmidlet.
English: Bridion has no known influence on the ability to drive and use machines.
Danish: Bridion har ingen kendt indvirkning på evnen til at føre motorkøretøj og betjene maskiner.
English: Sugammadex should only be administered by, or under the supervision of an anaesthetist.
Danish: Sugammadex bør kun administreres af eller under supervision af en anæstesilæge.
English: • Bridion can make hormonal contraceptives - including the ‘Pill', vaginal ring, implants or a hormonal IntraUterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone.
Danish: • Bridion kan nedsætte effekten af hormonelle præventionsmidler - inklusive p-piller, vaginalring, implantat eller hormonspiral - fordi det reducerer mængden af hormonet progestogen, som du får.
English: N.V. Organon Kloosterstraat 6 P.O.
Danish: Organon Kloosterstraat 6 P.O. Box 20
English: If sugammadex is administered to these patients monitoring of haemostasis and coagulation parameters is recommended.
Danish: Hvis sugammadex administreres til disse patienter, anbefales monitorering af hæmostase og koagulationsparametre.
English: In a human tolerance study sugammadex was administered in doses up to 96 mg/kg.
Danish: I et tolerancestudie på mennesker blev sugammadex administreret i doser op til 96 mg/kg.
English: Hormonal contraceptives:
Danish: Hormonelle præventionsmidler:
English: Preclinical studies in young adult and mature rats demonstrate that sugammadex does not adversely affect tooth colour or bone quality, bone structure, or bone metabolism.
Danish: Prækliniske studier med unge voksne og fuldt udviklede rotter har vist, at sugammadex ikke påvirker tandfarve eller knoglekvalitet, knoglestruktur eller knoglemetabolisme negativt.
English: A dose of 23 mg sodium is considered essentially ‘sodium-free'.
Danish: En dosis på 23 mg natrium anses som 'natriumfri'.
English: Pharmacodynamic effects:
Danish: Farmakodynamisk virkning:
English: 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).
Danish: Derfor anses administration af en bolus-dosis sugammadex for at svare til én glemt daglig dosis af et oralt præventionsmiddel (enten kombinations- eller rent progestogenpræparat).
English: Solution for injection (injection).
Danish: Injektionsvæske, opløsning (injektionsvæske).
English: Total exposure to sugammadex was prolonged, leading to 17-fold higher exposure in patients with severe renal impairment.
Danish: Den totale eksponering for sugammadex blev forlænget, hvilket medførte 17 gange højere eksponering hos patienter med svært nedsat nyrefunktion.
English: Administration of sugammadex to healthy volunteers resulted in increased renal elimination of rocuronium in complex.
Danish: Administration af sugammadex i raske frivillige resulterede i en øget renal eliminering af rocuroniumkomplekset.
English: Delayed recovery:
Danish: Forsinket opvågning:
English: Immediate reversal of rocuronium-induced blockade:
Danish: Øjeblikkelig revertering af rocuroniuminduceret blokade:
English: Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular blockade.
Danish: Ventilering af patienterne er påkrævet indtil tilstrækkelig spontan respiration er reetableret efter revertering af neuromuskulær blokade.
English: Use in Intensive Care Unit (ICU):
Danish: Anvendelse på intensiv terapi afsnit (ITA):
English: Following a second dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function.
Danish: Efter den anden dosis sugammadex skal patienten monitoreres tæt for at sikre vedvarende retablering af neuromuskulær funktion.
English: In post-marketing data and in one dedicated clinical trial in patients with a history of pulmonary complications, bronchospasm was reported as a possibly related adverse event.
Danish: Efter markedsføring og i et dedikeret klinisk forsøg hos patienter med lungekomplikationer i anamnesen blev der rapporteret bronkospasmer som en mulig relateret bivirkning.
English: Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent.
Danish: Sugammadex er et modificeret gammacyclodextrin, der er en Selektiv Relaksantia Antidot.
English: Pregnancy and breast-feeding → Tell your anaesthetist if you are pregnant or might be pregnant or if you are breast-feeding.
Danish: Graviditet og amning → Fortæl anæstesilægen, hvis du er gravid eller tror, du er gravid, eller hvis du ammer.
English: As is normal post-anaesthetic practice following neuromuscular blockade, it is recommended to monitor the patient in the immediate post-operative period for untoward events including recurrence of neuromuscular blockade.
Danish: Som ved almindelig postanæstesisk praksis efter neuromuskulær blokade, anbefales det at monitorere patienten i den umiddelbare post-operative periode for utilsigtede hændelser, herunder tilbagevenden af neuromuskulær blokade.
English: For toremifene, which has a relatively high binding affinity for sugammadex and for which relatively high plasma concentrations might be present, some displacement of vecuronium or rocuronium from the complex with sugammadex could occur.
Danish: For toremifen, som har en relativt høj bindingsaffinitet til sugammadex, og for hvilket der kan være relativt høje plasmakoncentrationer til stede, kan der forekomme nogen fortrængning af vecuronium eller rocuronium fra det dannede kompleks med sugammadex.
English: Bridion 100 mg/mL may be diluted to 10 mg/mL to increase the accuracy of dosing in the paediatric population (see section 6.6).
Danish: Bridion 100 mg/ml kan fortyndes til 10 mg/ml for at øge doseringsnøjagtigheden hos den pædiatriske population (se pkt.
English: • Complications during your procedure such as changes in heart rate, coughing or moving
Danish: • Komplikationer under behandlingen såsom ændringer i hjertefrekvens (puls), hoste eller bevægelser
English: Bridion is administered concomitantly with neuromuscular blocking agents and anaesthetics in surgical patients.
Danish: Bridion administreres samtidigt med neuromuskulære blokkere og anæstetika hos kirurgiske patienter.
English: Renal impairment and age:
Danish: Nedsat nyrefunktion og alder:
English: Should neuromuscular blockade reoccur following extubation, adequate ventilation should be provided.
Danish: Hvis neuromuskulær blokade vender tilbage efter ekstubation, skal tilstrækkelig ventilering foretages.
English: Sugammadex is rapidly cleared in preclinical species, although residual sugammadex was observed in bone and teeth of juvenile rats.
Danish: Sugammadex elimineres hurtigt hos diverse arter i prækliniske studier, selvom retention af sugammadex blev observeret i knogler og tænder hos unge rotter.
English: → If you are taking the Pill on the same day as Bridion is given to you, follow the instructions for a missed dose in the Pill's package leaflet.
Danish: → hvis du tager p-pillen samme dag, som du får Bridion, skal du følge vejledningen for en glemt dosis i indlægssedlen for p-pillen.
English: Clinicians should be prepared for the possibility of drug hypersensitivity reactions (including anaphylactic reactions) and take the necessary precautions (see section 4.8).
Danish: Læger bør være forberedt på mulige lægemiddeloverfølsomhedsreaktioner (inklusive anafylaktiske reaktioner) og derfor tage de nødvendige forholdsregler (se pkt.
English: Re-administration of sugammadex:
Danish: Gen-administration af sugammadex:
English: Marked bradycardia:
Danish: Udtalt bradykardi:
English: The most commonly reported adverse reactions in surgical patients were cough, airway complication of anaesthesia, anaesthetic complications, procedural hypotension and procedural complication (Common (≥ 1/100 to < 1/10)).
Danish: De hyppigst rapporterede bivirkninger hos kirurgiske patienter var hoste, luftvejskomplikationer forårsaget af anæstesi, anæstesikomplikationer, hypotension under indgrebet og behandlingskomplikationer (Almindelig (≥ 1/100 til < 1/10)).
English: The sugammadex pharmacokinetic parameters were calculated from the total sum of non-complexbound and complex-bound concentrations of sugammadex.
Danish: De farmakokinetiske parametre for sugammadex var beregnet ud fra den totale sum af nonkompleksbundne og kompleksbundne koncentrationer af sugammadex.