FrancophonIA/ELRC3.0 huggingface dataset:
English: Resumption or initiation of oral maintenance antiarrhythmic therapy can be considered starting 2 hours after vernakalant administration.
Danish: Genoptagelse eller initiering af orale antiarytmika til vedligeholdelsesbehandling kan overvejes med start 2 timer efter administration af vernakalant.
English: Post-cardiac surgery patients: No dose adjustment necessary.
Danish: Patienter efter hjerteoperation: Dosisjustering er ikke nødvendig.
English: Vernakalant should be used with caution in patients on oral AADs (class I and III), due to limited experience.
Danish: Vernakalant bør anvendes med forsigtighed hos patienter i oral behandling med antiarytmika (klasse I og III) grundet begrænset erfaring.
English: Due to the higher incidence of the adverse reactions of hypotension and ventricular arrhythmia in patients with CHF, vernakalant should be used cautiously in haemodynamically stable patients with CHF functional classes NYHA I to II.
Danish: På grund af den højere incidens af bivirkningerne hypotension og ventrikulær arytmi hos patienter med venstresidig hjerteinsufficiens bør vernakalant anvendes med forsigtighed hos hæmodynamisk stabile patienter med venstresidig hjerteinsufficiens i henhold til den funktionelle NYHA-klassifikation I til II.
English: Resumption or initiation of oral maintenance antiarrhythmic therapy after this time period can be considered (see sections 4.3 and 4.4).
Danish: Genoptagelse eller initiering af oral vedligeholdelsesbehandling med antiarytmika efter dette tidsrum kan overvejes (se pkt.
English: • if you take certain other intravenous medicines (antiarrhythmics Class I and III) used to normalize an abnormal heart rhythm, 4 hours before BRINAVESS is to be used
Danish: • hvis De tager anden medicin i en blodåre (antiarytmika klasse I og III) til normalisering af unormal hjerterytme 4 timer før, BRINAVESS skal bruges.
English: In post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Danish: I post-marketing erfaring sjældne tilfælde af atrieflagren med 1:1 atrioventrikulær overledning overholdes.
English: Valvular heart disease
Danish: Valvulær hjertesygdom
English: As a precautionary measure, it is preferable to avoid the use of BRINAVESS during pregnancy.
Danish: For en sikkerheds skyld bør vernakalant undgås under graviditeten.
English: • feeling light-headed or fainting, generally feeling unwell, feeling drowsy or sleepy
Danish: • ørhed eller besvimelse, generel utilpashed, døsighed eller søvnighed
English: If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 2 mg/kg may be administered (maximum second infusion of 226 mg (56.5 ml of 4 mg/ml solution)).
Danish: Hvis konvertering til sinusrytme ikke indtræffer senest 15 minutter efter afslutning af den initiale infusion, kan endnu en 10-minutters infusion på 2 mg/kg gives (maksimal 2. infusion på 226 mg (56,5 ml af 4 mg/ml opløsningen)).
English: -For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration
Danish: Efter hjerteoperation: atrieflimren ≤ 3 dages varighed.
English: The Marketing Authorisation Holder shall provide a check list in each pack, the text of which is included in Annex IIIA.
Danish: Indehaveren af markedsføringstilladelsen skal forsyne hver pakning med en tjekliste.
English: Patients with CHF showed a higher overall incidence of hypotensive events, during the first 2 hours after dose in patients treated with vernakalant compared to patients receiving placebo (13.4 % versus 4.7 %, respectively).
Danish: Patienter med venstresidig hjerteinsufficiens udviste overordnet en højere incidens af hypotensive hændelser i løbet af de første 2 timer efter dosering hos patienter, der var blevet behandlet med vernakalant sammenlignet med patienter, der fik placebo (henholdsvis 13,4 % og 4,7 %).
English: Package leaflet: Information for the user BRINAVESS 20 mg/ml concentrate for solution for infusion vernakalant hydrochloride
Danish: Indlægsseddel: Information til brugeren BRINAVESS 20 mg/ml koncentrat til infusionsvæske, opløsning vernakalanthydrochlorid
English: If conversion to sinus rhythm did not occur with the initial infusion or within the 15 minute observation period, administer a 2 mg/kg second infusion over 10 minutes.
Danish: Hvis konvertering til sinusrytme ikke indtræffer med den initiale infusion eller inden for en efterfølgende 15 minutters observationsperiode, indgives endnu en infusion på 2 mg/kg over 10 minutter.
English: Patients with renal impairment: No dose adjustment necessary (see section 5.2).
Danish: Patienter med nyreinsufficiens: Dosisjustering er ikke nødvendig (se pkt.
English: Recommended diluents are sodium chloride 9 mg/ml (0.9 %) solution for injection, Lactated Ringers solution for injection, or 5 % glucose for solution for injection.
Danish: Natriumchlorid 9 mg/ml (0,9 %) til injektionsvæske, opløsning, Ringer-lactat injektionsvæske, opløsning, eller 5 % glucose til injektionsvæske, opløsning, bør anvendes til fortynding.
English: • Use of intravenous rhythm control antiarrhythmics (class I and class III) within 4 hours prior to, as well as in the first 4 hours after, BRINAVESS administration.
Danish: • Brug af intravenøse antiarytmika til rytmekontrol (klasse I og III) op til 4 timer før samt i de første 4 timer efter administration af BRINAVESS.
English: Hypotension reported as a serious adverse experience or leading to medicinal product discontinuation occurred in CHF patients following exposure to vernakalant in 1.8 % of these patients compared to 0.3 % in placebo.
Danish: Hypotension rapporteret som alvorlig bivirkning eller førende til seponering af medicinen forekom hos patienter med venstresidig hjerteinsufficiens, efter de havde fået vernakalant, hos 1,8 % af patienterne sammenlignet med 0,3 % for placebo.
English: Patients with a history of CHF showed a higher incidence of ventricular arrhythmia in the first two hours post dose (6.4% for vernakalant compared to 1.6% in placebo).
Danish: Patienter med venstresidig hjerteinsufficiens i anamnesen udviste en højere incidens af ventrikulær arytmi i de første to timer efter dosering (6,4 % for vernakalant sammenlignet med 1,6% for placebo).
English: • a disease of the heart valves
Danish: • sygdom i hjerteklapperne
English: If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 226 mg (56.5 ml of 4 mg/ml solution) may be administered.
Danish: Hvis konvertering til sinusrytme ikke indtræffer senest 15 minutter efter afslutning af den initiale infusion, kan endnu en 10-minutters infusion på 226 mg (56,5 ml af 4 mg/ml opløsningen) gives.
English: If you are given more BRINAVESS than you should
Danish: Hvis De har fået for meget BRINAVESS
English: Common: Hypotension Uncommon: Flushing; hot flush; pallor
Danish: Almindelig: Hypotension Ikke almindelig: Rødmen; hedeture; bleghed
English: • choking sensation
Danish: • kvælningsfornemmelse
English: Pharmacotherapeutic group: Cardiac therapy, other antiarrhythmics class I and III; ATC code: C01BG11.
Danish: Farmakoterapeutisk klassifikation: Hjerteterapi, andre antiarytmika klasse I og III.
English: Common: Pruritus; hyperhidrosis Uncommon: Pruritus generalised; cold sweat
Danish: Hud og subkutane væv Almindelig: Pruritus; hyperhidrose Ikke almindelig: Generaliseret pruritus; koldsved
English: Although vernakalant is a substrate of CYP2D6, population pharmacokinetic (PK) analyses demonstrated that no substantial differences in the acute exposure of vernakalant (Cmax and AUC0-90 min) were observed when weak or potent CYP2D6 inhibitors were administered within 1 day prior to vernakalant infusion compared to patients that were not on concomitant therapy with CYP2D6 inhibitors.
Danish: Sammenlignet med patienter, som ikke var i samtidig behandling med CYP2D6, viste farmakokinetiske populationsanalyser ingen væsentlige forskelle i den akutte eksponering af vernakalant (Cmax og AUC0-90 min), når svage eller potente CYP2D6-hæmmere blev administreret op til 1 dag før infusion af vernakalant, og selvom vernakalant er et substrat af CYP2D6.
English: If any of the above apply to you (or you are not sure), talk to your doctor.
Danish: Tal med lægen, hvis noget af ovenstående passer på Dem (eller De er i tvivl).
English: Atrial fibrillation patients receiving vernakalant have a higher incidence of converting to atrial flutter within the first 2 hours post-dose (1.2 % versus 0 % in placebo).
Danish: Patienter med atrieflimren, som fik vernakalant, havde en højere incidens af konvertering til atrieflagren inden for de første 2 timer efter dosering (1,2 % versus 0 % for placebo).
English: • excessive sweating, itching
Danish: • øget svedtendens, kløe
English: If such signs develop, discontinue BRINAVESS immediately and provide appropriate medical management.
Danish: Hvis sådanne tegn opstår, skal BRINAVESS-infusionen straks stoppes, og patienten skal have hensigtsmæssig behandling.
English: • generalised itching
Danish: • generel kløe
English: Use of AADs (antiarrhythmic drugs) prior to or after vernakalant Vernakalant cannot be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant due to lack of data.
Danish: Anvendelse af antiarytmika før eller efter vernakalant Vernakalant bør ikke gives til patienter, der tidligere har fået antiarytmika (klasse I og III) 4-24 timer før vernakalant grundet mangel på data.
English: *The adverse reactions included in the table occurred within 24 hours of administration of vernakalant (see sections 4.2 and 5.2) with an incidence > 0.1 % of vernakalant patients and higher than placebo **see section below
Danish: 4.2 og 5.2) med en incidens > 0.1 % af de patienter, der fik vernakalant, og højere end placebo **se afsnittet nedenfor
English: Only a well-qualified healthcare professional should administer BRINAVESS and should frequently monitor the patient for the duration of the infusion and for at least 15 minutes after the completion of the infusion for signs and symptoms of a sudden decrease in blood pressure or heart rate (see section 4.4).
Danish: Kun en kvalificeret sundhedsperson må administrere BRINAVESS, og patienten skal monitoreres hyppigt under hele infusionsforløbet og i mindst 15 minutter efter afsluttet infusion for tegn og symptomer på pludseligt fald i blodtryk eller hjertefrekvens (se pkt.
English: However, in post-marketing experience rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Danish: Men efter markedsføring er der observeret sjældne tilfælde af atrieflagren med 1:1 atrioventrikulær overledning.
English: • BRINAVESS cannot be recommended in patients previously administered intravenous AADs (class I and III) 4-24 hours prior to vernakalant, due to lack of data.
Danish: • BRINAVESS bør ikke gives til patienter, der tidligere har fået intravenøse antiarytmika (klasse I og III) 4-24 timer før vernakalant grundet manglende data.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen
English: There is no clinical experience with direct-current cardioversion under 2 hours post-dose.
Danish: Der er ingen klinisk erfaring med defibrillering inden for 2 timer efter start af infusion.
English: Common: Infusion site pain; feeling hot; infusion site paraesthesia Uncommon: Fatigue; infusion site irritation; infusion site hypersensitivity; infusion site pruritus; malaise
Danish: Ikke almindelig: Træthed; irritation på infusionsstedet; overfølsomhed på infusionsstedet;;pruritus på infusionsstedet; utilpashed
English: BRINAVESS 20 mg/ml concentrate for solution for infusion
Danish: BRINAVESS 20 mg/ml, koncentrat til infusionsvæske, opløsning
English: Each ml of concentrate contains 20 mg vernakalant hydrochloride equivalent to 18.1 mg vernakalant.
Danish: En ml koncentrat indeholder 20 mg vernakalanthydrochlorid svarende til 18,1 mg vernakalant.
English: BRINAVESS 20 mg/ml sterile concentrate vernakalant hydrochloride IV
Danish: BRINAVESS 20 mg/ml, sterilt koncentrat vernakalanthydrochlorid Intravenøst
English: 200 mg/10 ml
Danish: 1 hætteglas 200 mg/10 ml
English: It must not be administered in patients who received intravenous AADs (class I and III) within 4 hours prior to vernakalant (see section 4.3).
Danish: Det må ikke gives til patienter, som har fået intravenøse antiarytmika (klasse I og III) op til 4 timer før vernakalant (se pkt.
English: Each 25 ml vial contains 500 mg of vernakalant hydrochloride equivalent to 452.5 mg of vernakalant.
Danish: Et 25 ml hætteglas indeholder 500 mg vernakalanthydrochlorid svarende til 452,5 mg vernakalant.
English: Breast-feeding
Danish: Atrieflagren
English: Uncommon: Pain in extremity
Danish: Ikke almindelig: Ekstremitetssmerter
English: Uncommon: Dyspnoea; throat irritation; oropharyngeal pain; nasal congestion; suffocation feeling; choking sensation; rhinorrhoea Gastrointestinal disorders Common: Nausea; paraesthesia oral; vomiting Uncommon: Dry mouth; diarrhoea; hypoaesthesia oral; defecation urgency
Danish: Almindelig: Hoste; nasalt ubehag Ikke almindelig: Dyspnø; halsirritation; orofaryngeale smerter; tilstoppet næse; kvælningsfornemmelse; kvælningsfornemmelse, rinorré
English: BRINAVESS 20 mg/ml concentrate for solution for infusion vernakalant hydrochloride
Danish: BRINAVESS 20 mg/ml, koncentrat til infusionsvæske, opløsning vernakalanthydrochlorid
English: Vernakalant must not be administered in patients who received intravenous AADs (class I and III) within 4 hours prior to vernakalant (see section 4.3).
Danish: Vernakalant må ikke gives til patienter, som har fået intravenøse antiarytmika (klasse I og III) mindre end 4 timer før vernakalant (se pkt.
English: Each vial contains 500 mg vernakalant hydrochloride equivalent to 452.5 mg vernakalant.
Danish: Et hætteglas indeholder 500 mg vernakalanthydrochlorid svarende til 452,5 mg vernakalant.
English: How to store BRINAVESS Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: 25 mL:1 vial 500 mg/25 ml
Danish: 1 hætteglas 500 mg/25 ml
English: What BRINAVESS looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Patients with hepatic impairment: No dose adjustment necessary (see sections 4.4 and 5.2).
Danish: Patienter med leverinsufficiens: Dosisjustering er ikke nødvendig (se pkt.
English: • Use of intravenous rhythm control antiarrhythmics (class I and class III) within 4 hours prior to,
Danish: • Brug af intravenøse antiarytmika til rytmekontrol (klasse I og III) op til 4 timer før samt i de første 4 timer efter administration af vernakalant.
English: • sneezing
Danish: • nysen
English: Each vial of 500 mg of vernakalant hydrochloride is equivalent to 452.5 mg of vernakalant.
Danish: Et hætteglas med 500 mg vernakalanthydrochlorid svarer til 452,5 mg vernakalant.
English: Each vial of 200 mg vernakalant hydrochloride is equivalent to 181 mg vernakalant.
Danish: Et hætteglas med 200 mg vernakalanthydrochlorid svarer til 181 mg vernakalant.
English: Each 10 ml vial contains 200 mg of vernakalant hydrochloride equivalent to 181 mg of vernakalant.
Danish: Et 10 ml hætteglas indeholder 200 mg vernakalanthydrochlorid svarende til 181 mg vernakalant.
English: Each vial contains 200 mg vernakalant hydrochloride equivalent to 181 mg vernakalant.
Danish: Et hætteglas indeholder 200 mg vernakalanthydrochlorid svarende til 181 mg vernakalant.
English: What BRINAVESS is and what it is used for What you need to know before you use BRINAVESS How to use BRINAVESS
Danish: Det skal De vide, før De begynder at bruge BRINAVESS Sådan skal De bruge BRINAVESS Bivirkninger
English: Uncommon: Hypoaesthesia; burning sensation; parosmia; syncope; somnolence
Danish: Meget almindelig: Smagsforstyrrelser Almindelig: Paræstesi; svimmelhed Ikke almindelig: Hypæstesi; brændende fornemmelse; parosmi; synkope; døsighed
English: Patients should be frequently monitored for the duration of the infusion and for at least 15 minutes after the completion of the infusion for signs and symptoms of a sudden decrease in blood pressure or heart rate.
Danish: Kun en kvalificeret sundhedsperson må administrere BRINAVESS, og patienten skal monitoreres hyppigt under hele infusionsforløbet og i mindst 15 minutter efter afsluttet infusion for tegn og symptomer på et pludseligt fald i blodtryk eller hjertefrekvens.
English: Any vials exhibiting particulate matter or discolouration should not be used.
Danish: Brug ikke hætteglas med partikelindhold eller misfarvning.
English: The recommended initial dose is 3 mg/kg, with a maximum calculated dose based upon 113 kg.
Danish: Den anbefalede startdosis er 3 mg/kg med en maksimal dosis baseret på 113 kg. Mens De får BRINAVESS, vil Deres åndedræt, hjerterytme, blodtryk og hjertets elektriske aktivitet blive kontrolleret.
English: An infusion pump is the preferred delivery device.
Danish: Det anbefales at anvende en infusionspumpe til indgivelse.
English: Zubrin should not be used in people.
Danish: Zubrin bør ikke anvendes til mennesker.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Zubrin on 13 March 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse for Zubrin med gyldighed i hele Den Europæiske Union 13. marts 2001.
English: Vomiting or diarrhoea has been observed in one out of 10 dogs.
Danish: Opkastning og diarré er iagttaget hos én ud af 10 hunde.
English: Occasionally, loss of hair or red patches on the skin might occurr.
Danish: Lejlighedsvis kan der forekomme hårtab eller røde pletter på huden.
English: Information on the prescription status of this product may be found on the label of the carton.
Danish: Oplysninger om udleveringsbestemmelser for produktet findes på kartonens etiket.
English: When these enzymes are blocked, less prostaglandin is produced.
Danish: Når disse enzymer blokeres, produceres der mindre prostaglandin.
English: Zubrin has been studied in laboratory animals, as well as in dogs that were treated in various veterinary practices/clinics in the USA and in a number of countries in Europe (“clinical studies”).
Danish: Zubrin er undersøgt såvel i laboratoriedyr som hos hunde, der er blevet behandlet på forskellige dyrlægepraksisser eller -klinikker i USA og i en række europæiske lande ("kliniske forsøg").
English: Zubrin should be placed directly into the dog's mouth and you should try to keep the mouth of the dog closed for a short while.
Danish: Zubrin skal anbringes direkte i munden på hunden, og du skal prøve at holde hundens mund lukket et par sekunder.
English: Zubrin contains the active substance tepoxalin.
Danish: Zubrin indeholder det aktive stof tepoxalin.
English: The best results were achieved when Zubrin was adminstered 1-2 hours after feeding.
Danish: De bedste resultater opnåedes, når Zubrin blev givet 1-2 timer efter fodring.
English: Zubrin acts by blocking enzymes, cyclooxygenase-1 and cyclooxygenase-2.
Danish: Zubrin virker ved at blokere enzymerne cyclooxygenase-1 og cyclooxygenase-2.
English: Also, before you start using Zubrin, inform the veterinarian if your dog receives any other medication since some medicines might influence each other's effectiveness.
Danish: Inden du begynder at give hunden Zubrin, skal du desuden oplyse dyrlægen om eventuel anden medicin, som hunden får, da visse lægemidler kan påvirke hinandens virkning.
English: In these clinical studies, the animal owners gave Zubrin to their dogs, once daily at a dose of 10 mg per kg dog's bodyweight with or without food.
Danish: I de kliniske forsøg har dyrets ejer givet Zubrin til hunden én gang dagligt i en dosis på 10 mg pr. kg af dyrets kropsvægt, med eller uden foder.
English: Zubrin contains tepoxalin, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Zubrin indeholder tepoxalin, der tilhører en klasse lægemidler med betegnelsen nonsteroide antiinflammatoriske lægemidler (NSAID).
English: Zubrin is given to the dog once a day within 1-2 hours after feeding until the dog gets better.
Danish: Zubrin gives én gang dagligt 1-2 timer efter fodring, indtil hunden får det bedre.
English: However, if a number of tablets are accidentially consumed by a person, the advice of a doctor should be sought immediately.
Danish: I tilfælde, hvor mennesker utilsigtet indtager adskillige tabletter, bør der straks søges lægehjælp.
English: When such undesirable effects are seen in the dog, you should discontinue giving Zubrin to your dog.
Danish: Når din hund får sådanne bivirkninger, skal du ophøre med at give hunden Zubrin.
English: Why has Zubrin been approved?
Danish: Hvorfor er Zubrin blevet godkendt?
English: However, since side effects might occur, any treatment exceeding 1 - 2 weeks should be under regular veterinary supervision.
Danish: Da bivirkninger kan forekomme, skal enhver behandling af mere end 1-2 ugers varighed dog ske under regelmæssigt tilsyn af dyrlægen.
English: If the lyophilisate disintegrates prematurely in your hands, wash your hands thoroughly.
Danish: Hvis tabletten opløses i hånden, skal du vaske hænder grundigt.
English: In rare cases, particularly in older or in sensitive dogs, these effects may become very serious.
Danish: I sjældne tilfælde kan disse bivirkninger blive meget alvorlige, især hos ældre eller ekstra følsomme dyr.
English: Zubrin was as effective as other medicines of the same class and showed significant improvement in dogs with muscle or joint disease.
Danish: Zubrin var lige så effektivt som andre lægemidler i samme klasse og bevirkede en væsentlig bedring hos hunde med sygdomme i muskler eller led.
English: Its purpose is to explain how the assessment done by the CVMP on the basis of the documentation provided led to the recommendations on the conditions of use.
Danish: Formålet er at forklare, hvordan Udvalget for Veterinærlægemidlers (CVMP) vurdering af den forelagte dokumentation førte til, at man anbefalede at anvende lægemidlet som beskrevet nedenfor.
English: The animals were treated until they got better; however, since side effects might occur, any treatment exceeding 1 - 2 weeks should be under regular veterinary supervision.
Danish: Dyrene blev behandlet, indtil deres tilstand bedredes, men da bivirkninger kan forekomme, skal enhver behandling af mere end 1-2 ugers varighed følges regelmæssigt af dyrlægen.
English: Therefore, you should make sure to administer the medicine with dry hands.
Danish: Derfor skal du sørge for at have tørre hænder, når du giver lægemidlet.
English: Zubrin is an oral lyophilisate, i.e. a kind of tablet that will quickly disintegrate upon contact with moisture e.g. when placed on your dog's tongue.
Danish: Zubrin er en smeltetablet, dvs. en type tablet, der hurtigt opløses, når den fugtes, f.eks. når den lægges på din hunds tunge.
English: What is Zubrin?
Danish: Hvad er Zubrin?
English: The side effects of Zubrin are those seen with other NSAIDs, such as vomiting, soft faeces or diarrhoea, blood in faeces, reduced appetite and tiredness.
Danish: Bivirkningerne af Zubrin er de samme som af andre NSAID, dvs. opkastning, blød afføring eller diarré, blod i afføringen, nedsat appetit og træthed.
English: As the prostaglandins are substances that trigger inflammation, tepoxalin reduces the inflammation and the swelling of muscles or joints and the pain associated with this.
Danish: Da prostaglandiner er stoffer, der udløser en betændelsesreaktion, mindsker tepoxalin den betændelse og hævelse af muskler og led og den smerte, som de bevirker.
English: How has the effectiveness of Zubrin been studied?
Danish: Hvordan er virkningen af Zubrin undersøgt?
English: What is Zubrin used for?
Danish: Hvad anvendes Zubrin til?
English: Zubrin has a special pharmaceutical form (lyophilisate) that will quickly dissolve upon contact with moisture and might get very slippery or sticky when kept in your fingers.
Danish: Zubrin har en særlig lægemiddelform (smeltetablet), der hurtigt opløses, når den bliver fugtig, og kan blive meget glat eller klæbrig ved berøring med fingrene.