FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is a sublingual tablet of 5 mg or 10 mg two times a day.
Danish: Den sædvanlige dosis er 1 sublingual resoriblet (til placering under tungen) på 5 mg eller 10 mg 2 gange dagligt.
English: The incidences of the ADRs associated with asenapine therapy are tabulated below.
Danish: Forekomsten af bivirkninger i forbindelse med asenapin-behandling er anført i nedenstående tabel.
English: Asenapine has anaesthetic properties.
Danish: Asenapin har bedøvende egenskaber.
English: OUTER CARTON (10 mg)
Danish: YDRE KARTON (10 mg)
English: Indicative of CYP2D6 inhibition, treatment with asenapine 5 mg twice daily resulted in a fractional decrease in DX/DM ratio to 0.43.
Danish: Behandling med 5 mg asenapin to gange dagligt resulterede i et minimalt fald i DX/DM-forholdet til 0,43, hvilket tyder på CYP2D6-hæmning.
English: The proportion of subjects with clinically significant weight gain (≥ 7 % weight gain from baseline at Day 21) was 14.1 % for asenapine 2.5 mg twice daily, 8.9 % for asenapine 5 mg twice daily, and 9.2 % for asenapine 10 mg twice daily, compared to 1.1 % for placebo.
Danish: Procentdelen af forsøgspersoner med klinisk signifikant vægtstigning (≥ 7 % vægtstigning fra baseline til dag 21) var 14,1 % for asenapin 2,5 mg to gange dagligt, 8,9% for asenapin 5 mg to gange dagligt og 9,2 % for asenapin 10 mg to gange dagligt sammenlignet med 1,1 % for placebo.
English: OUTER CARTON (5 mg)
Danish: YDRE KARTON (5 mg)
English: In vitro studies indicate that asenapine weakly inhibits CYP2D6.
Danish: In vitro forsøg indikerer, at asenapin er en svag hæmmer af CYP2D6.
English: - Do not swallow or chew on the tablet.
Danish: - Du må ikke synke eller tygge resoribletten.
English: If signs and symptoms of tardive dyskinesia appear in a patient on Sycrest, discontinuation of treatment should be considered.
Danish: Seponering bør overvejes, hvis der opstår tegn eller symptomer på tardiv dyskinesi hos patienter, som behandles med Sycrest.
English: In most cases it was not clear if asenapine had been taken sublingually.
Danish: De rapporterede estimerede doser var mellem 15 og 400 mg. I de fleste tilfælde var det ikke klart, om asenapin var blevet taget sublingualt.
English: Asenapine may cause somnolence and sedation.
Danish: Asenapin kan give somnolens eller virke sløvende.
English: Do not crush the tablet.
Danish: Knus ikke resoribletten.
English: No dose adjustment is required for patients with mild hepatic impairment.
Danish: Der kræves ingen dosisjusteringer for patienter med let nedsat leverfunktion.
English: How to take Sycrest
Danish: Sådan skal du tage Sycrest
English: Sycrest is for sublingual use.
Danish: Sycrest er til anvendelse under tungen.
English: Eating and drinking should be avoided for 10 minutes after administration.
Danish: Man bør undgå at spise og drikke i 10 minutter efter indtag.
English: Therefore, Sycrest should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures.
Danish: Sycrest bør derfor anvendes med forsigtighed hos patienter, der tidligere har haft krampeanfald eller på anden måde er i risiko for at udvikle kramper.
English: Given the primary effects of asenapine on the central nervous system (CNS) (see section 4.8), caution should be used when it is taken in combination with other centrally acting medicinal products.
Danish: 4.8), bør der udvises forsigtighed, når det tages i kombination med andre centralt virkende lægemidler.
English: Co-administration of a single 20 mg dose of paroxetine (a CYP2D6 substrate and inhibitor) during treatment with 5 mg asenapine twice daily in 15 healthy male subjects resulted in an almost 2-fold increase in paroxetine exposure.
Danish: - I et forsøg med 15 raske forsøgspersoner resulterede samtidig indgift af en enkelt 20 mg dosis af paroxetin (et CYP2D6-substrat og hæmmer), under behandling med 5 mg asenapin to gange dagligt næsten i en fordobling i paroxetin-eksponering.
English: Cases of dysphagia were occasionally reported in patients treated with Sycrest.
Danish: Der er set tilfælde af dysfagi hos patienter behandlet med Sycrest.
English: Each sublingual tablet contains 10 mg asenapine (as maleate).
Danish: Hver sublingual resoriblet indeholder 10 mg asenapin (som maleat).
English: Each sublingual tablet contains 5 mg asenapine (as maleate).
Danish: Hver sublingual resoriblet indeholder 5 mg asenapin (som maleat).
English: In clinical trials, cases of syncope were occasionally reported during treatment with Sycrest.
Danish: I kliniske studier er der lejlighedsvis set tilfælde af besvimelser under behandling med Sycrest.
English: The 10 mg sublingual tablets are round white to off-white tablets marked with “10” on one side.
Danish: Sycrest 10 mg sublinguale resoribletter er runde, hvide til råhvide resoribletter mærket med ”10” på den ene side.
English: Other medicines and Sycrest
Danish: Brug af anden medicin sammen med Sycrest
English: Syncope Seizure
Danish: Parkinsonisme Sedation
English: In subjects with severe hepatic impairment (Child-Pugh C), a 7-fold increase in asenapine exposure was observed.
Danish: Hos patienter med svært nedsat leverfunktion (Child-Pugh C) er asenapin-eksponering 7-dobbelt.
English: If you do, you should not take Sycrest if you have difficulty controlling core body temperature if you have thoughts of suicide if you have abnormally high levels of prolactin in the blood (hyperprolactinaemia)
Danish: - hvis du har et unormalt højt indhold af hormonet prolaktin i blodet (hyperprolaktinæmi).
English: In clinical trials, cases of seizure were occasionally reported during treatment with asenapine.
Danish: Der er i kliniske studier lejlighedsvis set tilfælde af kramper under behandling med asenapin.
English: Gynaecomastia Galactorrhoea
Danish: Gynækomasti Galaktoré
English: Extrapyramidal disorder Dysarthria Restless legs syndrome
Danish: Besvimelse Kramper Ekstrapyramidal e bivirkninger Dysartri
English: If you miss two or more doses, contact your doctor or pharmacist.
Danish: Kontakt din læge eller apoteket, hvis du har glemt to eller flere doser.
English: Because of its α1-adrenergic antagonism with potential for inducing orthostatic hypotension (see section 4.4), Sycrest may enhance the effects of certain antihypertensive agents.
Danish: Sycrest kan forstærke effekten af visse antihypertensive midler, pga. dens α1-adrenerge antagonisme med mulighed for at inducere ortostatisk hypotension (se pkt.
English: - increased saliva (drooling) - muscle tightness - fatigue - increase in the level of liver proteins
Danish: - forandringer i smagssansen - følelsesløshed af tungen eller i munden - øget spytproduktion (savlen) - muskelstramhed - træthed - forhøjet niveau af leverenzymer.
English: EU/1/10/640/001 20 sublingual tablets EU/1/10/640/002 60 sublingual tablets EU/1/10/640/003 100 sublingual tablets
Danish: EU/1/10/640/001 20 resoribletter, sublinguale EU/1/10/640/002 60 resoribletter, sublinguale EU/1/10/640/003 100 resoribletter, sublinguale
English: EU/1/10/640/004 20 sublingual tablets EU/1/10/640/005 60 sublingual tablets EU/1/10/640/006 100 sublingual tablets
Danish: EU/1/10/640/004 20 resoribletter, sublinguale EU/1/10/640/005 60 resoribletter, sublinguale EU/1/10/640/006 100 resoribletter, sublinguale
English: Sublingual tablet Round, white to off-white, sublingual tablets debossed with “5” on one side.
Danish: Resoriblet, sublingual Runde, hvide til råhvide resoribletter, sublinguale, præget med ”5” på den ene side.
English: If you take too much Sycrest, contact a doctor straight away.
Danish: Kontakt straks lægen, hvis du har taget for meget Sycrest.
English: Sublingual tablet Round, white to off-white, sublingual tablets debossed with ”10” on one side.
Danish: Resoriblet, sublingual Runde, hvide til råhvide resoribletter, sublinguale, præget med ”10” på den ene side.
English: Sycrest 5 mg sublingual tablets Sycrest 10 mg sublingual tablets asenapine
Danish: Sycrest 5 mg resoribletter, sublinguale Sycrest 10 mg resoribletter, sublinguale asenapin
English: tongue, or jaw, slow or sustained muscle contractions, muscle spasms, tremor (shaking),
Danish: (EPS), som inkluderer en eller flere af følgende: unormale bevægelser af muskler, tunge eller kæbe, langsomme eller vedvarende muskelsammentrækninger, muskelspasmer, rysten
English: If you are taking this medicine and you become pregnant or you plan to get pregnant, ask your doctor as soon as possible whether you may continue taking Sycrest.
Danish: Tal straks med lægen om du skal fortsætte med dette lægemiddel, hvis du bliver gravid eller har planer om at blive gravid.
English: What Sycrest looks like and contents of the pack The 5 mg sublingual tablets are round white to off-white tablets marked with “5” on one side.
Danish: Sycrest 5 mg sublinguale resoribletter er runde, hvide til råhvide resoribletter mærket med ”5” på den ene side.
English: Dystonia Akathisia Dyskinesia Parkinsonism Sedation Dizziness Dysgeusia
Danish: Døsighed Dystoni Akatisi
English: If you take more Sycrest than you should
Danish: Hvis du har taget for meget Sycrest
English: What Sycrest is and what it is used for What you need to know before you take Sycrest How to take Sycrest
Danish: Det skal du vide, før du begynder at tage Sycrest Sådan skal du tage Sycrest Bivirkninger
English: Dysphagia
Danish: Dyskinesi
English: Hepatic impairment
Danish: Hævet tunge Dysfagi
English: Muscle rigidity
Danish: Svimmelhed Dysgeusi
English: Sycrest 10 mg sublingual tablets
Danish: Sycrest 10 mg resoribletter, sublinguale
English: Sycrest 5 mg sublingual tablets asenapine
Danish: Sycrest 5 mg resoribletter, sublinguale asenapin
English: Do not eat or drink for 10 minutes after taking the tablet.
Danish: Der må ikke drikkes ellers spises i 10 minutter efter resoribletten er taget.
English: Sycrest 5 mg sublingual tablets
Danish: Sycrest 5 mg resoribletter, sublinguale
English: confusion and fluctuating blood pressure which may lead to coma - convulsions, fits or seizures - fainting - falls which may occur as a result of one or more adverse events such as: sleepiness, sudden drops in blood pressure when you stand up, dizziness and changes in your ability to move and balance.
Danish: Kontakt straks en læge, hvis du oplever et eller flere af følgende symptomer: - allergiske reaktioner (omfatter som regel flere symptomer såsom problemer med at trække vejret eller synke, hævet ansigt, læber, tunge eller svælg, hududslæt, kløe og øget hjertefrekvens (puls)) - pludseligt øget kropstemperatur med øget svedproduktion, hurtige hjerteslag, svær muskelstivhed, forvirring og svingende blodtryk, som kan føre til koma - krampetrækninger eller krampeanfald - besvimelse - fald, som kan ske som et resultat af en eller flere bivirkninger såsom: søvnighed, pludseligt fald i blodtrykket, når du rejser dig op, svimmelhed og ændret bevægelses- og balanceevne.
English: Sycrest 10 mg sublingual tablets asenapine
Danish: Sycrest 10 mg resoribletter, sublinguale asenapin
English: Swollen tongue Dysphagia Glossodynia Paraesthesia oral
Danish: Oral hypæstesi Kvalme Øget spytsekretion
English: The possibility of a suicide attempt is inherent in psychotic illnesses and bipolar disorder and close supervision of high-risk patients should accompany treatment.
Danish: Risikoen for et selvmordsforsøg er øget hos patienter med psykotiske lidelser og bipolar lidelse.
English: The proportion of subjects with clinically significant weight gain (≥ 7 % weight gain from baseline at endpoint) in the short-term schizophrenia trials was 5.3 % for asenapine compared to 2.3 % for placebo.
Danish: I de kombinerede kortvarige og langvarige studier af skizofreni og bipolar mani hos voksne var den gennemsnitlige ændring i kropsvægt for asenapin-behandlede 0,8 kg. Andelen af patienter med klinisk signifikant vægtstigning (≥ 7 % vægtstigning fra baseline til endepunkt) i de kortvarige skizofrenistudier var 5,3 % for asenapin, sammenlignet med 2,3 % for placebo.
English: Do not crush, chew or swallow.
Danish: Må ikke knuses, tygges eller synkes hel.
English: Renal impairment
Danish: Restless legs
English: The tablet should not be removed from the blister until ready to take it. Dry hands should be used when touching the tablet.
Danish: Resoribletten bør ikke tages ud af blisterpakningen, før den skal indtages.
English: Cardiac disorders
Danish: Dysfagi
English: In the combined short-term and long-term schizophrenia and bipolar mania trials in adults, the mean change in body weight for asenapine was 0.8 kg.
Danish: I de kombinerede kortvarige og langvarige studier af skizofreni- og bipolar mani hos voksne, var den gennemsnitlige ændring i kropsvægt for asenapin-behandlede 0,8 kg. Andelen af patienter med klinisk signifikant vægtstigning (≥ 7 % vægtstigning fra baseline til endepunkt) i de kortvarige skizofrenistudier var 5,3 % for asenapin, sammenlignet med 2,3 % for placebo.
English: {Invented name} can be used when lithium can not be used.
Danish: {Navn} kan bruges, når lithium ikke kan bruges.
English: - Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive.
Danish: - Mani, hvor du kan føle dig eksalteret, opstemt, ophidset, entusiastisk eller hyperaktiv.
English: Patients receiving daily doses higher than 45mg/kg/day body weight should be carefully monitored.
Danish: Patienter, der får daglige doser på mere end 45 mg/kg legemsvægt, bør monitoreres nøje.
English: The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect.
Danish: Dosis skal øges så hurtigt, som det er muligt til at nå den laveste terapeutiske dosis, som giver den ønskede kliniske effekt.
English: Children and adolescents under 18 years of age: {Invented name} should not be used in children and adolescents under 18 years of age for the treatment of mania.
Danish: Børn og unge under 18 år: {Navn} bør ikke bruges til behandling af mani hos børn og unge under 18 år.
English: The safety and efficacy of {invented name} for the treatment of manic episodes in bipolar disorder have not been evaluated in patients aged less than 18 years.
Danish: Sikkerhed og virkning af [navn] til behandling af maniske episoder ved bipolær lidelse er ikke blevet evalueret hos patienter under 18 år.
English: ANNEX III AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND THE PACKAGE LEAFLET These amendments to the SPC and package leaflet are valid at the time of the Commission Decision.
Danish: BILAG III TILLÆG TIL PRODUKTRESUME OG INDLÆGSSEDDEL Disse ændringer til produktresumé og indlægsseddel er gældende fra Kommissionens beslutning.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Danish: Patienter (og omsorgspersoner) skal rådes til at søge læge, hvis der opstår tegn på selvmordstanker eller suicidal adfærd.
English: Take special care with {INVENTED NAME}
Danish: Vær ekstra forsigtig med at tage {navn}
English: WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR {Invented name} is a medicine for the treatment of (…) and mania.
Danish: VIRKNING OG ANVENDELSE {Navn} er medicin til behandling af […..] og mani.
English: Continuation of treatment of manic episodes in bipolar disorder should be adapted individually using the lowest effective dose.
Danish: Fortsættelse af behandling for maniske episoder ved bipolær lidelse skal tilpasses individuelt med anvendelse af den laveste, effektive dosis.
English: Nausea, sedation, extrapyramidal disorders.
Danish: Kvalme, sedation, ekstrapyramidale forstyrrelser.
English: The mean daily dose usually ranges between 1000 and 2000 mg <valproate>.
Danish: Den vedligeholdelsesdosis ligger sædvanligvis på mellem 1.000 og 2.000 mg valproat.
English: A small number of people being treated with anti-epileptics such as <active substance> have had thoughts of harming or killing themselves.
Danish: En lille andel af de personer, som bliver behandlet med epilepsimedicin som for eksempel valproat, har haft tanker om at gøre skade på sig selv eller begå selvmord.
English: Mania The daily dosage should be established and controlled individually by your doctor.
Danish: Mani Den daglige dosis er individuel og skal fastsættes og kontrolleres af din læge.
English: HOW TO TAKE {INVENTED NAME}
Danish: SÅDAN SKAL DU TAGE {NAVN}
English: Mean daily dose The recommended daily doses usually range between 1000 mg and 2000 mg.
Danish: Vedligeholdelsesdosis De anbefalede daglige doser ligger normalt på mellem 1.000 mg og 2.000 mg.
English: BEFORE YOU TAKE {INVENTED NAME}
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE {NAVN}
English: AMENDMENTS TO BE INCLUDED IN SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR VALPROIC ACID/VALPROATE CONTAINING MEDICINAL PRODUCTS, AS RELEVANT
Danish: TILLÆG TIL DE RELEVANTE AFSNIT AF PRODUKTRESUMEET FOR LÆGEMIDLER INDEHOLDENDE VALPROINSYRE/VALPROAT
English: The initial recommended daily dose is 750 mg.
Danish: Den anbefalede initialdosis er 750 mg daglig.
English: AMENDMENTS TO BE INCLUDED IN SECTIONS OF THE PACKAGE LEAFLET FOR VALPROIC ACID /VALPROATE CONTAINING PRODUCTS, AS RELEVANT
Danish: TILLÆG TIL DE RELEVANTE AFSNIT AF INDLÆGSSEDLEN FOR LÆGEMIDLER INDEHOLDENDE VALPROINSYRE/VALPROAT
English: Initial dose The recommended initial daily dose is 750 mg.
Danish: Startdosis Den anbefalede startdosis er 750 mg daglig.
English: SUMMARY OF PRODUCT CHARACTERISITICS
Danish: PRODUKTRESUME
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, indgivelsesvej, indehavere af markedsføringstilladelser i Medlemsstaterne
English: 8 , Quinta da Beloura 2710-444 Sintra Portugal
Danish: 8 , Quinta da Beloura 2710-444 Sintra
English: 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex
Danish: 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex France
English: Kemistvägen 1B, Box 1150, 18311 Täby, Sweden
Danish: Novartis Sverige AB Kemistvägen 1B, Box 1150, 18311 Täby, Sweden
English: 12 km of National Road Athens, Lamia N° 1, 14451 Metamorphosis, Athens Greece
Danish: 12 km of National Road Athens, Lamia N° 1, 14451
English: Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43-47 Hungary
Danish: Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43
English: Novartis Norge AS Postboks 4284 Nydalen, 0401 Oslo
Danish: Novartis Norge AS Postboks 4284 Nydalen,
English: United Kingdom Novartis Pharmaceuticals UK Limited Trading as Ciba Laboratories Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR
Danish: Trading as Ciba Laboratories Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR United Kingdom
English: Novartis Sverige AB
Danish: Novartis Finland Oy
English: Belgium Novartis Pharma N.V. Medialaan, 40 bus 1, 1800 Vilvoorde Belgium
Danish: Medialaan, 40 bus 1, 1800 Vilvoorde
English: Czech Republic Novartis s.r.o., Gemini, budova B Na Pankráci 1724/129
Danish: Novartis s.r.o., Gemini, budova B Na Pankráci 1724/129 140 00 Prague 4
English: 90429 Nuernberg Germany
Danish: 90429 Nuernberg
English: Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, N° 764 08013 Barcelona
Danish: Novartis Farmacéutica, S.A. Gran Via de les Corts Catalanes, N° 764
English: Novartis Farma - Produtos Farmacêuticos S.A.
Danish: Novartis Farma - Produtos
English: Slovak Republic Novartis, s.r.o.
Danish: Novartis, s.r.o.
English: Femara 2.5mg Filmcoated Tablets
Danish: Femara 2.5mg Film-coated Tablets
English: Novartis Pharma GmbH Roonstrasse 25
Danish: Novartis Pharma GmbH Roonstraße 25
English: Novartis Europharm Ltd Wimblehurst Road
Danish: Novartis Europharm Ltd Wimblehurst Road RH12 5 Ab - Horsham (West
English: 140 00 Prague 4
Danish: 0401 Oslo
English: Femara 2.5mg Tablets 2.5 mg
Danish: Femara 2,5mg Filmtabletten 2,5 mg
English: Femara 2,5mg filmtabletta
Danish: Femara 2,5mg filmtabletta 2,5 mg
English: Laboratorios Padró, S.A.
Danish: Farmacêuticos S.A.
English: The studies involved a total of 1,237 patients with an average age above 60 years.
Danish: Undersøgelserne omfattede i alt 1.237 patienter med en gennemsnitsalder på over 60 år.
English: International Non-proprietary Name (INN): dronedarone
Danish: Internationalt fællesnavn (INN): dronedaron
English: The application was at day 174 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 174, da virksomheden trak sin ansøgning tilbage.
English: Atrial fibrillation and flutter are very common conditions, particularly in people over 65 years of age.
Danish: Atrieflimren og -flagren er meget hyppige tilstande, særligt blandt personer over 65 år.
English: What is MULTAQ?
Danish: Hvad er MULTAQ?
English: The effects of MULTAQ were first tested in experimental models before being studied in humans.
Danish: Virkningerne af MULTAQ er først blevet testet i forsøgsmodeller, inden det blev undersøgt hos mennesker.
English: What documentation has the company presented to support its application to the CHMP?
Danish: Hvilken dokumentation har virksomheden fremlagt for at underbygge sin ansøgning til CHMP?
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for MULTAQ
Danish: SPØRGSMÅL OG SVAR I FORBINDELSE MED TILBAGETRÆKNING AF MARKEDSFØRINGSANSØGNINGEN for MULTAQ
English: MULTAQ is a medicine that consists of tablets containing 400 mg of dronedarone.
Danish: MULTAQ er et lægemiddel, der består af tabletter indeholdende 400 mg dronedaron.
English: All of the patients had had atrial fibrillation or flutter at least once in the past three months but had a normal heart rhythm at the start of the study.
Danish: Alle patienterne havde haft atrieflimren eller atrieflagren mindst én gang inden for de sidste tre måneder, men havde en normal hjerterytme ved undersøgelsens begyndelse.
English: The study measured the change in heart rate between the start of the study and day 14 of treatment.
Danish: I undersøgelsen måltes ændringen i hjertefrekvens fra undersøgelsens begyndelse og frem til dag 14 i behandlingen.
English: The active substance in MULTAQ, dronedarone, is an anti-arrhythmic agent.
Danish: Det aktive stof i MULTAQ, dronedaron, er et antiarytmikum.
English: It is expected to correct altered heartbeat by affecting the electrical activity of the heart muscle.
Danish: Det forventes at korrigere ændret hjerteslag ved at påvirke den elektriske aktivitet i hjertemusklen.
English: Following a CHMP opinion, it usually takes around 2 months for the European Commission to grant a licence.
Danish: Når CHMP har afgivet en udtalelse, går der som regel cirka 2 måneder, før Europa-Kommissionen udsteder en markedsføringstilladelse.
English: In addition, MULTAQ can alter the levels of some other medicines.
Danish: Derudover kan MULTAQ ændre koncentrationerne af visse andre lægemidler.
English: On 6 September 2006, sanofi-aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for MULTAQ, for the treatment of atrial fibrillation and atrial flutter.
Danish: Den 6. september 2006 meddelte sanofi-aventis officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at man ønsker at trække sin ansøgning om markedsføringstilladelse for MULTAQ til behandling af atrieflimren og atrieflagren tilbage.
English: Therefore, at the time of the withdrawal, the CHMP's view was that further studies were needed to adequately assess the medicine's benefits and risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP således af den opfattelse, at der var behov for yderligere undersøgelser for at danne et tilstrækkeligt grundlag for en vurdering af lægemidlets fordele og risici.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with MULTAQ?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, som deltager i kliniske undersøgelser med MULTAQ?
English: Both illnesses cause a rapid heart rate, but atrial fibrillation also makes the heart rhythm irregular.
Danish: Begge lidelser fremkalder en hurtig hjertefrekvens, men atrieflimren gør desuden hjerterytmen uregelmæssig.