FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypotension typically occurs early, either during the infusion or early after the end of the infusion, and can usually be corrected by standard supportive measures.
Danish: Hypotension forekommer typisk tidligt, enten under infusionen eller tidligt efter afslutning af infusionen, og kan normalt korrigeres ved hjælp af understøttende standardbehandling.
English: Patients with body weight > 113 kg:
Danish: Patienter med en kropsvægt på >113 kg:
English: There was no meaningful difference when stratifying the analysis by therapeutic indication (i.e. non-surgery and post-cardiac surgery patients).
Danish: Der var ingen betydningsfuld forskel, når analysen blev stratificeret ud fra terapeutisk indikation (dvs. ikke-opererede patienter og patienter efter hjerteoperation).
English: Talk to your doctor before using BRINAVESS if you have any of the following problems:
Danish: Kontakt lægen, før De får BRINAVESS, hvis De har et eller flere af følgende problemer:
English: Cumulative doses above 565 mg have not been evaluated.
Danish: Akkumulerede doser over 565 mg er ikke vurderet.
English: In patients with hepatic impairment, exposures were elevated by 9 to 25 %.
Danish: Hos patienter med leverinsufficiens øgedes eksponeringen med 9 til 25 %.
English: The amount of BRINAVESS you may be given will depend on your weight.
Danish: Den mængde BRINAVESS De får vil afhænge af Deres vægt.
English: BRINAVESS will be diluted before being given to you.
Danish: BRINAVESS vil blive fortyndet, inden det gives til Dem.
English: Vernakalant is extensively and rapidly distributed in the body, with a volume of distribution of approximately 2 l/kg.
Danish: Vernakalant fordeles ekstensivt og hurtigt i kroppen med en fordelingsvolumen på ca. 2 l/kg.
English: Step 2: Dilution of concentrate
Danish: Trin 2: Fortynding af koncentrat
English: It should be taken into account that some people may get dizzy after receiving BRINAVESS, usually within the first 2 hours (see section “Possible side effects”).
Danish: Der bør tages hensyn til, at nogle mennesker kan føle svimmelhed efter at have fået BRINAVESS, normalt inden for de første 2 timer (se Bivirkninger).
English: Cases of serious hypotension have been reported during and immediately following vernakalant infusion.
Danish: Der er set alvorlige tilfælde af hypotension under og umiddelbart efter infusion af vernakalant.
English: BRINAVESS should not be administered as an intravenous push or bolus.
Danish: BRINAVESS bør ikke indgives som intravenøs push eller bolusdosis.
English: If such signs develop, with or without symptomatic hypotension or bradycardia, the infusion should be stopped immediately.
Danish: Hvis sådanne tegn opstår, med eller uden symptomatisk hypotension eller bradykardi, skal infusionen stoppes omgående.
English: • Bradycardia
Danish: • Bradykardi
English: Does the patient have prolonged QT interval at baseline (uncorrected > 440 msec)?
Danish: Har patienten forlænget QT-interval ved baseline (ukorrigeret > 440 ms)?
English: There are no data from the use of vernakalant hydrochloride in pregnant women.
Danish: Der er ingen data fra anvendelse af vernakalanthydrochlorid til gravide kvinder.
English: Table 1: Adverse reactions with BRINAVESS *
Danish: Tabel 1: Bivirkninger ved BRINAVESS*
English: Your doctor will consider if you need additional rhythm control medicine 4 hours after using BRINAVESS.
Danish: Lægen vil overveje, om De har brug for yderligere medicin til rytmekontrol 4 timer efter brugen af BRINAVESS.
English: The free fraction of vernakalant in human serum is 53-63 % at concentration range of 1-5 μg/ml.
Danish: Vernakalants frie fraktion i human serum er 53-63 % i koncentrationsområdet 1-5 µg/ml.
English: Important Instructions when using BRINAVESS
Danish: Vigtige instruktioner ved anvendelse af BRINAVESS
English: No patients with NYHA III/IV were included in the study.
Danish: Der blev ikke inkluderet patienter med NYHA III/IV i undersøgelsen.
English: Geodis Logistics Netherlands B.V. Columbusweg 16
Danish: Geodis Logistics Netherlands B.V.
English: If your heart beat has not returned to normal 15 minutes after the end of your first dose, you may be given a second dose.
Danish: Hvis Deres hjerterytme ikke er vendt tilbage til det normale 15 minutter efter, De har fået første dosis, får De eventuelt endnu en dosis.
English: BRINAVESS will be given to you by a health care professional.
Danish: De vil få BRINAVESS af sundhedspersonalet.
English: Clear and colourless to pale yellow solution with a pH of approximately 5.5.
Danish: Klar og farveløs til svagt gul opløsning med pH på ca. 5,5.
English: If you are not sure, talk to your doctor before you use this medicine.
Danish: Hvis De er i tvivl, skal De tale med lægen, før De bruger denne medicin.
English: To ensure proper administration, a sufficient amount of BRINAVESS 20 mg/ml should be prepared at the outset of therapy to deliver the initial and second infusion should it be warranted.
Danish: For at sikre korrekt administration bør der tilberedes en tilstrækkelig mængde BRINAVESS 20 mg/ml ved starten af behandlingen til både 1. og 2. infusion, i tilfælde af at denne er indiceret.
English: • the electrical activity of your heart (uncommon)
Danish: • hjertets elektriske aktivitet (ikke almindelige)
English: Sodium hydroxide (E524) (for pH-adjustment)
Danish: Natriumhydroxid (E524) (til justering af pH)
English: BRINAVESS contains sodium
Danish: BRINAVESS indeholder natrium
English: Pharmacodynamics effects
Danish: Farmakodynamisk virkning
English: EXP Diluted solution: use within 12 hours and store at or below 25 °C.
Danish: EXP Fortyndet opløsning: Anvendes inden for 12 timer og opbevares ved eller under 25 °C.
English: Preparation of BRINAVESS for infusion
Danish: Tilberedning af BRINAVESS til infusion
English: There is no experience on the use of BRINAVESS in children and adolescents less than 18 years of age; therefore its use is not recommended.
Danish: Der er ingen erfaring med anvendelse af BRINAVESS til børn og unge under 18 år, og derfor bør det ikke anvendes.
English: If these events occur during the first infusion of vernakalant, patients should not receive the second dose.
Danish: Hvis disse hændelser indtræffer under 1. infusion af vernakalant, bør patienterne ikke få 2. dosis.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single- and repeated-dose toxicity, and genotoxicity.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter enkelte og gentagne doser samt genotoksicitet.
English: Studies in animal have shown malformations after repeated oral exposure (see section 5.3).
Danish: Dyreforsøg har vist fostermisdannelser efter gentagen oral eksponering (se pkt.
English: BRINAVESS must be diluted before it is used.
Danish: BRINAVESS skal fortyndes, før det anvendes.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er brugeren ansvarlig for opbevaringstiden under anvendelsen og forholdene før anvendelse, som normalt ikke bør være længere end 24 timer ved 2-8 °C, med mindre fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Detailed information on warnings and precautions relating to side effects that could occur are presented in section 4.
Danish: I punkt 4 er der givet nærmere oplysninger om advarsler og forsigtighedsregler vedrørende de bivirkninger, der kan opstå.
English: Some patients with typical atrial flutter were included in ACT II and ACT III and vernakalant was not found to be effective in converting atrial flutter.
Danish: Nogle patienter med typisk atrieflagren var inkluderet i ACT II og ACT III, og vernakalant blev ikke fundet effektivt til konvertering af atrieflagren.
English: Do not use this medicine if you notice particulate matter or discolouration.
Danish: Brug ikke lægemidlet, hvis De bemærker partikelindhold eller misfarvning.
English: These arrhythmias typically presented as asymptomatic, monomorphic, non-sustained (average 3-4 beats) ventricular tachycardias.
Danish: Disse arytmier udgjordes typisk af asymptomatiske, monomorfiske, ikke-vedvarende (gennemsnitligt 3-4 slag) ventrikulære takykardier.
English: • certain heart diseases involving the heart muscle, lining that surrounds the heart and a severe narrowing of the heart valves
Danish: • visse hjertesygdomme der involverer hjertemusklen, hjertesækken der omgiver hjertet samt alvorlig forsnævring af hjerteklapperne
English: • irritation, itching at the infusion site
Danish: • irritation, kløe på infusionsstedet
English: There are no clinical data on repeat doses after the initial and second infusions.
Danish: Der er ingen kliniske data for gentagen dosering efter 1. og 2. infusion.
English: Treatment with vernakalant did not affect the response rate to electrical cardioversion (including the median number of shocks or joules required for successful cardioversion) in cases when attempted within 2 to 24 hours of study medicine administration.
Danish: Behandling med vernakalant påvirkede ikke responset på elektrisk konvertering (inklusive det gennemsnitlige antal shock eller joules, der kræves for vellykket konvertering) i de tilfælde, hvor det blev forsøgt inden for 2-24 timer efter administration af studiemedicinen.
English: In clinical studies, the need for anticoagulation prior to administration of vernakalant was assessed as per clinical practice of the treating physician.
Danish: I kliniske undersøgelser blev behovet for antikoagulering før administration af vernakalant vurderet i henhold til den behandlende læges kliniske praksis.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen, hvis De bruger anden medicin, for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: Step 3: Inspection of the solution
Danish: Trin 3: Kontroller opløsningen
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ
English: If conversion to sinus rhythm has not occurred, the patient's vital signs and cardiac rhythm should be observed for an additional 15 minutes.
Danish: Hvis konvertering til sinusrytme ikke indtræffer, skal patientens vitale tegn og hjerterytme observeres i yderligere 15 minutter.
English: Does the patient have severe aortic stenosis?
Danish: Har patienten svær aortastenose?
English: What you need to know before you use BRINAVESS Do not use BRINAVESS
Danish: Det skal De vide, før De begynder at bruge BRINAVESS Brug ikke BRINAVESS
English: By 24 hours there appears to be insignificant levels of vernakalant.
Danish: Efter 24 timer er kun set en ubetydelig koncentration af vernakalant.
English: Uncommonly, cases of severe hypotension have been observed.
Danish: Der er set sjældne tilfælde af svær hypotension.
English: BRINAVESS may be available in different vial sizes (available vial sizes to be inserted locally).
Danish: BRINAVESS vil måske kunne fås i forskellige hætteglasstørrelser (de tilgængelige hætteglasstørrelser indsættes lokalt).
English: Prior to administration the prescriber is asked to determine eligibility of the patient through use of the supplied checklist.
Danish: Før administration skal lægen tage stilling til patientens egnethed ved anvendelse af den medfølgende tjekliste.
English: BRINAVESS works by changing your irregular or fast heart beat to a normal heart beat.
Danish: BRINAVESS virker ved at ændre Deres uregelmæssige eller hurtige hjerterytme til normal hjerterytme.
English: Very common: Sneezing
Danish: Meget almindelig: Nysen
English: (see sections 4.4 Hypotension, Congestive Heart Failure).
Danish: 4.4 Hypotension, Venstresidig hjerteinsufficiens).
English: • decreased feeling or sensitivity
Danish: • nedsat følelse eller følsomhed
English: For patients above 113 kg, vernakalant has a fixed dose.
Danish: For patienter, der vejer over 113 kg, har vernakalant en fast dosis.
English: Cumulative doses of greater than 5 mg/kg should not be administered within 24 hours.
Danish: Akkumulerede doser på mere end 5 mg/kg bør ikke gives inden for 24 timer.
English: The Cmax and AUC were dose proportional between 0.5 mg/kg and 5 mg/kg.
Danish: Cmax og AUC var dosisproportionale i området 0,5 mg/kg-5 mg/kg.
English: Median time to conversion to SR as reported among all patients who, as per the investigator judgement, converted to SR was 12 minutes and in most of the treatment episodes (60.4%) only one infusion was administered.
Danish: Mediantiden til konvertering til sinusrytme som rapporteret blandt alle patienter, som i henhold til investigators vurdering konverterede til sinusrytme, var 12 minutter, og i de fleste behandlingsepisoder (60,4%) blev der kun givet én infusion.
English: It is unknown whether vernakalant/metabolites are excreted in human milk.
Danish: Det er ukendt, om vernakalant/metabolitter udskilles i human mælk.
English: The Marketing Authorisation Holder shall ensure that all healthcare professionals (HCP) involved in the administration of BRINAVESS are provided with a healthcare professional information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle i sundhedspersonalet, der er involveret i administration af BRINAVESS, får en informationspakke til læger og sundhedspersonale, som indeholder følgende:
English: • if you have an abnormally slow heart rate or skipped heart beats and do not have a pacemaker, or you have conduction disturbance called QT prolongation - which can be seen on an ECG by your doctor
Danish: • hvis De har unormalt langsom hjerterytme eller hjerteslag, der springer over, og De ikke har pacemaker, eller De har ledningsforstyrrelser, som kaldes QT-forlængelse - som kan ses på et elektrokardiogram (EKG) hos lægen
English: • if you are allergic to vernakalant hydrochloride or any of the other ingredients of this medicine (listed in section 6)
Danish: • hvis De er allergisk over for vernakalanthydrochlorid eller et af de øvrige indholdsstoffer i BRINAVESS (angivet i punkt 6)
English: Treatment success (responder) was defined as conversion of atrial fibrillation to sinus rhythm within 90 minutes.
Danish: Behandlingssucces (response) blev defineret som konvertering af atrieflimren til sinusrytme inden for 90 minutter.
English: Conversion of atrial fibrillation in patients with longer-duration atrial fibrillation (> 7 days and ≤ 45 days) assessed as a secondary efficacy endpoint in a total of 185 patients did not show statistically significant differences between vernakalant and placebo.
Danish: Konvertering af atrieflimren hos patienter med længerevarende atrieflimren (> 7 dage og ≤ 45 dage) og vurderet som sekundært effekt-endepunkt hos i alt 185 patienter viste ikke statistisk signifikante forskelle mellem vernakalant og placebo.
English: There is no relevant use of vernakalant in children and adolescents < 18 years of age in the current indication and therefore it should not be used in this population.
Danish: Der er ingen relevante indikationer for brug af vernakalant til børn og unge < 18 år, og det bør derfor ikke anvendes til denne population.
English: ACT I and ACT III studied the effect of vernakalant in the treatment of patients with sustained atrial fibrillation > 3 hours but not more than 45 days in duration.
Danish: ACT I og ACT III undersøgte virkningen af vernakalant i behandlingen af patienter med vedvarende atrieflimren > 3 timer men ikke af mere end 45 dages varighed.
English: In adults it is used if you have a fast, irregular heart beat called atrial fibrillation which has started recently, less than or equivalent to 7 days, for non-surgery patients and less than or equivalent to 3 days for post-cardiac surgery patients.
Danish: Hos voksne anvendes det, hvis De har en hurtig, uregelmæssig hjerterytme, som kaldes atrieflimren, som er startet for nylig, mindre end eller svarende til 7 dage, hos patienter, der ikke er opereret, og mindre end eller svarende til 3 dage hos patienter, der har fået foretaget hjerteoperation.
English: Does the patient have heart failure class NYHA III or NYHA IV?
Danish: Har patienten hjerteinsufficiens NYHA III eller NYHA IV?
English: Elderly (≥ 65 years): No dose adjustment necessary.
Danish: Ældre (≥ 65 år): Dosisjustering er ikke nødvendig.
English: With respect to reproduction no effects on pregnancy, embryo-foetal development, parturition or postnatal development were observed after intravenous administration of vernakalant at exposure levels (AUC) similar or below the human exposure levels (AUC) achieved after a single intravenous dose of vernakalant.
Danish: Med hensyn til reproduktion sås ingen effekt på graviditet, fosterudvikling, fødsel eller postnatal udvikling efter intravenøs administration af vernakalant ved eksponeringsniveauer (AUC), der var de samme eller under de humane eksponeringsniveauer (AUC) efter en enkelt intravenøs dosis vernakalant.
English: In patients, the typical total body clearance of vernakalant was estimated to be 0.41 l/hr/kg.
Danish: Hos patienterne blev den typiske totale clearance for vernakalant vurderet til at være 0,41 l/t/kg.
English: If atrial flutter is observed as secondary to treatment, continuation of infusion should be considered (see section 4.2).
Danish: Hvis atrieflagren ses sekundært til behandlingen, bør fortsættelse af infusion overvejes (se pkt.
English: Table 2: Conversion of Atrial Fibrillation to Sinus Rhythm in ACT I and ACT III Duration of
Danish: Tabel 2: Konvertering af atrieflimren til sinusrytme i ACT I og ACT III Varighed af atrieflimren
English: In AVRO, the amiodarone infusion was given over 2 hours (i.e., 1 hour loading dose of 5 mg/kg, followed by 1 hour maintenance infusion of 50 mg).
Danish: I AVRO blev amiodaron-infusionen givet over 2 timer (dvs. 1 times initialdosis på 5 mg/kg efterfulgt af 1 times vedligeholdelsesinfusion på 50 mg).
English: No formal interaction studies have been undertaken with vernakalant injection.
Danish: Der er ikke udført formelle interaktionsstudier med injektion af vernakalant.
English: Overall, the combination of effects of vernakalant on cardiac potassium and sodium currents results in substantial antiarrhythmic effects that are mainly concentrated in the atria.
Danish: Overordnet resulterer vernakalants kombinerede effekter på de kardielle kalium- og natriumkanaler i en væsentlig antiarytmisk effekt, som hovedsageligt er koncentreret i atrierne.
English: One patient who received 3 mg/kg of vernakalant over 5 minutes (instead of the recommended 10 minutes) developed haemodynamically stable wide complex tachycardia which resolved without sequelae.
Danish: En patient, som fik 3 mg/kg vernakalant over 5 minutter (i stedet for de anbefalede 10 minutter), udviklede hæmodynamisk stabil takykardi med brede komplekser, som svandt uden følgetilstande.
English: No dose adjustment is required for these conditions, nor on the basis of age, serum creatinine or CYP2D6 metaboliser status.
Danish: Dosisjustering er ikke påkrævet ved disse tilstande, heller ikke på basis af alder, serumkreatinin eller CYP2D6 metaboliseringsstatus.
English: • your blood pressure (such as a very low blood pressure causing a serious heart condition)
Danish: • blodtrykket (såsom meget lavt blodtryk, der forårsager en alvorlig hjertelidelse) (ikke almindelige)
English: Caution should be exercised when used in breast-feeding women.
Danish: Forsigtighed bør udvises ved anvendelse til ammende kvinder.
English: In all studies, patients received a 10minute infusion of 3.0 mg/kg BRINAVESS (or matching placebo) followed by a 15-minute observation period.
Danish: I alle undersøgelser fik patienterne 10 minutters infusion af 3,0 mg/kg BRINAVESS (eller tilsvarende placebo) efterfulgt af en 15 minutters observationsperiode.
English: In an electrophysiological study in patients, vernakalant significantly prolonged atrial effective refractory period in a dose-dependent manner, which was not associated with a significant increase in ventricular effective refractory period.
Danish: I en elektrofysiologisk undersøgelse hos patienter forlængede vernakalant signifikant den atriale effektive refraktærperiode på en dosisafhængig måde, som ikke var forbundet med en betydelig stigning i den ventrikulære effektive refraktærperiode.
English: The initial infusion is administered as a 3 mg/kg dose over 10 minutes.
Danish: Den initiale infusion indgives som en dosis på 3 mg/kg over 10 minutter.
English: Please refer to the Summary of Product Characteristics and the educational material for additional information prior to the use of BRINAVESS
Danish: Der henvises til Produktresumé og undervisningsmateriale for yderligere information før anvendelse af BRINAVESS.
English: • eye irritation, watery eyes or changes in your vision
Danish: • øjenirritation, rindende øjne eller ændringer i synet
English: The primary endpoint was the proportion of patients that achieved sinus rhythm (SR) at 90 minutes after initiating therapy, limiting the conclusions to the effects seen in this time window.
Danish: Det primære endepunkt var antallet af patienter, der opnåede sinusrytme 90 minutter efter initiering af behandlingen, og som begrænsede konklusionerne til de virkninger, der sås i dette tidsvindue.
English: In these studies treatment with vernakalant effectively converted atrial fibrillation to sinus rhythm as compared with placebo (see Table 2).
Danish: I disse undersøgelser konverterede behandling med vernakalant effektivt atrieflimren til sinusrytme i sammenligning med placebo (se tabel 2).
English: • A sudden drop in blood pressure or heart rate, with or without symptomatic hypotension or bradycardia
Danish: • Pludseligt fald i blodtryk eller hjertefrekvens, med eller uden symptomatisk hypotension eller bradykardi
English: It is not known whether BRINAVESS passes into the breast milk.
Danish: Det er ukendt, om BRINAVESS går over i modermælken.
English: Glucuronidation and renal excretion are the main mechanisms of elimination in CYP2D6 poor metabolisers.
Danish: Glucuronidering og renal ekskretion er de væsentligste eliminationsmekanismer hos poor CYP2D6-metabolizers.
English: The initial dose is 339 mg (84.7 ml of 4 mg/ml solution).
Danish: Den initiale dosis er 339 mg (84,7 ml af 4 mg/ml opløsningen).
English: Furthermore, it has not been evaluated in patients with clinically meaningful valvular stenosis, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis and its use cannot be recommended in such cases.
Danish: Desuden er vernakalant ikke blevet vurderet hos patienter med klinisk betydningsfuld valvulær stenose, hypertrofisk obstruktiv kardiomyopati, restriktiv kardiomyopati eller konstriktiv perikardit og bør ikke anvendes i disse tilfælde.
English: Patients with congestive heart failure (CHF) have been identified as a population at higher risk for hypotension.
Danish: Patienter med venstresidig hjerteinsufficiens er blevet identificeret som en population, der har højere risiko for hypotension (se pkt.
English: The check list will be provided with an adhesive in order to be placed on the infusion container.
Danish: Tjeklisten vil blive leveret med et klæbemiddel, således at den kan anbringes på infusionsbeholderen.
English: Vernakalant has a minor to moderate influence on the ability to drive and use machines.
Danish: Vernakalant påvirker kun i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Contains citric acid, sodium chloride, water for injections, sodium hydroxide (E524).
Danish: Indeholder citronsyre, natriumchlorid, vand til injektion, natriumhydroxid (E524).
English: BRINAVESS is dosed by patient body weight, with a maximum calculated dose based upon 113 kg.
Danish: BRINAVESS doseres i henhold til patientens kropsvægt med en maksimal dosis baseret på 113 kg.
English: Vernakalant is a moderate, competitive inhibitor of CYP2D6.
Danish: Vernakalant er en moderat, kompetitiv hæmmer af CYP2D6.