FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP, on the basis of these considerations, endorsed the following harmonised wording for the indication: “Vascace Plus is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled with cilazapril alone”
Danish: På grundlag af disse betragtninger godkendte CHMP følgende harmoniserede ordlyd for indikationen: "Vascace Plus er indiceret til behandling af hypertension hos patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af cilazapril alene".
English: Reviewing recent publications on this topic new information on cilazapril, which was considered relevant for physicians to treat their patients with Vascace Plus and which should be included in this document was not identified.
Danish: Ved en gennemgang af de seneste publikationer om dette emne blev der ikke fundet nye oplysninger om cilazapril, der blev anset for at være relevante for læger i forbindelse med behandling af patienter med Vascace Plus, og som skulle medtages i dette dokument.
English: In addition to the patients of these clinical trials the efficacy of the combination was also assessed in 1.297 patients of the original cilazapril monotherapy new drug application (NDA) who were treated with cilazapril and adjunctive hydrochlorothiazide (HCTZ).
Danish: Effekten af kombinationen blev vurderet hos patienterne i disse kliniske undersøgelser og derudover også hos 1 297 patienter i den oprindelige cilazapril-monoterapi New Drug Application (NDA), som blev behandlet med cilazapril og som tillægsbehandling med hydrochlorothiazid.
English: Based on these data the combination of cilazapril 5 mg with hydrochlorothiazide 12.5 mg, given once daily, is a rational clinical choice for patients whose blood pressure is not normalized on cilazapril monotherapy.
Danish: På grundlag af disse data er kombinationen af 5 mg cilazapril og 12,5 mg hydrochlorothiazid én gang dagligt et fornuftigt klinisk valg til patienter, hvis blodtryk ikke normaliseres med monoterapi med cilazapril.
English: The wording proposed by the MAH integrated all information provided in individual SPCs in different countries.
Danish: Den ordlyd, som indehaveren af markedsføringstilladelsen foreslog, omfattede alle oplysninger indeholdt i de enkelte produktresuméer i forskellige lande.
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Danish: Begrundelser for ændringer af produktresumé, etikettering og indlægsseddel
English: The CHMP endorsed the MAH proposal after the frequency categories used in the SPC of Vascace Plus had been harmonised with the ones of the SPC for Vascace.
Danish: CHMP godkendte indehaveren af markedsføringstilladelsens forslag, efter at de hyppighedskategorier, der anvendes i produktresuméet for Vascace Plus, var blevet harmoniseret med de kategorier, der anvendes i produktresuméet for Vascace.
English: The CHMP agreed the following: “When concomitant diuretic therapy is required in patients with severe renal impairment, a loop diuretic rather than a thiazide diuretic is preferred for use with cilazapril.
Danish: CHMP vedtog følgende: "Når samtidig diuretisk behandling er påkrævet hos patienter med svært nedsat nyrefunktion, foretrækkes et loop-diuretikum frem for et thiaziddiuretikum til brug sammen med cilazapril.
English: • the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Danish: • Formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen.
English: The MAH's initially proposed SPC and CDS included some additional information concerning the use of ACE inhibitors in the 1st trimester of pregnancy as a contraindication to ACE inhibitors.
Danish: Det af indehaveren af markedsføringstilladelsen oprindeligt foreslåede produktresumé og CDS omfattede supplerende oplysninger om brugen af ACE-hæmmere i graviditetens første trimester som en kontraindikation for ACE-hæmmere.
English: The information on HCTZ overdose is consistent with other approved ACEI and hydrochlorothiazide combinations (ramipril/HCTZ) SPC.
Danish: Oplysningerne om overdosering med hydrochlorothiazid er forenelige med andre godkendte produktresuméer for ACEI- og hydrochlorothiazidkombinationer (ramipril/hydrochlorothiazid).
English: To justify the proposed dosage (5 mg cilazapril and 12.5 mg hydrochlorothiazide) the MAH presented data from several placebo controlled randomized trials.
Danish: Som begrundelse for den foreslåede dosis (5 mg cilazapril og 12,5 mg hydrochlorothiazid) fremlagde indehaveren af markedsføringstilladelsen data fra adskillige randomiserede, placebokontrollerede undersøgelser.
English: The MAH proposed text also included an additional comment concerning the use of ACE inhibitors in patients with liver cirrhosis and ascites, as suggested by the CHMP for the EU harmonized Vascace SPC.
Danish: Den formulering, som indehaveren af markedsføringstilladelsen foreslog, omfattede en supplerende bemærkning om brugen af ACE-hæmmere hos levercirrosepatienter med ascites som foreslået af CHMP i forbindelse med det EU-harmoniserede produktresumé for Vascace.
English: Description of selected adverse reactions as follows: “Headache is a commonly reported adverse event, although the incidence of headache is greater in patients receiving placebo than in those receiving cilazapril + hydrochlorothiazide”.
Danish: En forklarende note er medtaget i underpunkt (c) Beskrivelse af bestemte bivirkninger: "Hovedpine er en almindeligt indberettet bivirkning, selv om forekomsten af hovedpine er højere hos patienter, der modtager placebo, end hos dem, der modtager cilazapril + hydrochlorothiazid".
English: The MAH proposed as harmonised text the following wording: “Vascace Plus is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled with cilazapril alone or hydrochlorothiazide alone and who have been stabilized on the individual components given in the same proportions.”
Danish: Indehaveren af markedsføringstilladelsen foreslog følgende ordlyd som den harmoniserede tekst: "Vascace Plus er indiceret til behandling af hypertension hos patienter, hvis blodtryk ikke kan kontrolleres tilfredsstillende ved hjælp af cilazapril alene eller hydrochlorothiazid alene, og som er blevet stabiliseret på de enkelte komponenter givet i de samme mængder".
English: Considering this, the MAH suggested to include a warning concerning the use of thiazides in patients with a history of gout, but not to include gout as a contraindication.
Danish: På denne baggrund foreslog indehaveren af markedsføringstilladelsen, at der medtages en advarsel om brugen af thiazider hos patienter, som tidligere har haft urinsyregigt, men at urinsyregigt ikke medtages som en kontraindikation.
English: The CHMP acknowledged that the cilazapril part of this section had been aligned with the approved Vascace SPC.
Danish: CHMP anerkendte, at cilazaprildelen af dette punkt var blevet bragt på linje med det godkendte produktresumé for Vascace.
English: The CHMP, considering that there is plausible effect based on the pharmacologic action of the drug to affect the ability to drive, endorsed the following: “When driving and operating machines, it should be taken into account that occasionally dizziness and fatigue may occur during treatment with Vascace Plus (see sections 4.4 and 4.8)”.
Danish: CHMP mente, at der på basis af lægemidlets farmakologiske virkning er en sandsynlig effekt på evnen til at føre motorkøretøj, og godkendte følgende ordlyd: "Ved føring af motorkøretøj og betjening af maskiner bør der tages hensyn til, at der kan forekomme lejlighedsvis svimmelhed og træthed under behandling med Vascace Plus (se pkt.
English: Of these, 68 patients responded to monotherapy with cilazapril and 70 patients to hydrochlorothiazide.
Danish: 68 af disse patienter reagerede på cilazapril som monoterapi og 70 på hydrochlorothiazid.
English: The MAH proposed to include a warning concerning hypotension and renal impairment resulting from combination therapy with cilazapril and hydrochlorothiazide in patients with renal artery stenosis.
Danish: Indehaveren af markedsføringstilladelsen foreslog, at der medtages en advarsel om hypotension og nedsat nyrefunktion som følge af kombinationsterapi med cilazapril og hydrochlorothiazid hos patienter med nyrearteriestenose.
English: The text proposed by the MAH was based on Meyler's reviews of ACE inhibitors and thiazide diuretics, and it is consistent with the CDS and most current SPCs for Vascace Plus.
Danish: Den formulering, som indehaveren af markedsføringstilladelsen foreslog, var baseret på Meylers gennemgange af ACEhæmmere og thiaziddiuretika og er forenelig med CDS og de fleste aktuelle produktresuméer for Vascace Plus.
English: Some SPCs included a detailed description of the symptoms of anaphylaxis.
Danish: Nogle produktresuméer omfattede en detaljeret beskrivelse af symptomerne på anafylakse.
English: The proposed text for hepatic disorders incorporated all the information which was provided in the CDS and in local SPCs for Vascace Plus, and was consistent with wording used in the reviews in Meyler and Martindale.
Danish: Den foreslåede formulering for leverlidelser omfattede alle oplysningerne i CDS og i lokale produktresuméer for Vascace Plus og var forenelig med den ordlyd, der anvendes i gennemgangene hos Meyler og Martindale.
English: As requested, the ADR “arrhythmia”, already shown in the table of ADRs attributable to cilazapril, has been added to the table of ADRs attributable to hydrochlorothiazide.
Danish: Som krævet er bivirkningen "arytmi", som allerede fremgår af tabellen over bivirkninger, der kan tilskrives cilazapril, blevet tilføjet i tabellen over bivirkninger, der kan tilskrives hydrochlorothiazid.
English: The CHMP agreed to change the text “Pregnancy and lactation (see section 4.6)” under this section to “Second and third trimesters of pregnancy (see sections 4.4 and 4.6)”.
Danish: 4.6)" under dette punkt til "Graviditetens andet og tredje trimester (se pkt.
English: The CHMP asked the MAH to align the SPC for Vascace Plus with the approved SPC of Vascace and endorsed the harmonized wording for this subparagraph.
Danish: CHMP bad indehaveren af markedsføringstilladelsen om at tilpasse produktresuméet for Vascace Plus til det godkendte produktresumé for Vascace og godkendte den harmoniserede ordlyd for dette underpunkt.
English: Reviewing recent publications on this topic information on the pharmacokinetic properties of cilazapril and hydrochlorothiazide, which was considered relevant for physicians to treat their patients with Vascace Plus and which should be included in this document was not identified.
Danish: Ved en gennemgang af de seneste publikationer om dette emne blev der ikke fundet nye oplysninger om cilazapril og hydrochlorothiazid, som blev anset for at være relevante for læger i forbindelse med behandling af patienter med Vascace Plus, og som skulle medtages i dette dokument.
English: The ADR ‘lupus like syndrome' is now listed under the SOC Immune System Disorders in both subsections of the table of ADRs (i.e., ADRs attributable to cilazapril and ADRs attributable to HCTZ).
Danish: Bivirkningen "lupuslignende syndrom" er nu opført under systemorganklassen "Forstyrrelser i immunsystemet" under begge underpunkter i tabellen over bivirkninger (dvs. bivirkninger, der kan tilskrives cilazapril, og bivirkninger, der kan tilskrives hydrochlorothiazid).
English: The MAH agreed with the CHMP comment and the wording recommended by the PhVWP was used as harmonised text.
Danish: Indehaveren af markedsføringstilladelsen var enig i CHMP's bemærkning, og i den ordlyd, som arbejdsgruppen vedrørende lægemiddelovervågning foreslog blev anvendt som den harmoniserede ordlyd.
English: The CHMP endorsed the harmonised wording.
Danish: CHMP godkendte den harmoniserede ordlyd.
English: Following the request of the CHMP, the SPC has been amended by the MAH.
Danish: På CHMP's anmodning har indehaveren af markedsføringstilladelsen ændret produktresuméet.
English: The CHMP endorsed the harmonised wording under this section.
Danish: CHMP godkendte den harmoniserede ordlyd under dette punkt.
English: The MAH proposed to include a warning concerning gout in section 4.4.
Danish: Indehaveren af markedsføringstilladelsen foreslog, at der medtages en advarsel om urinsyregigt i punkt 4.4.
English: The CHMP endorsed this section.
Danish: CHMP godkendte dette punkt.
English: The text proposed by the MAH and endorsed by CHMP for anaphylaxis was consistent with the current Vascace Plus CDS and reviews of ACE inhibitors in Meyler and Martindale.
Danish: Den formulering, som indehaveren af markedsføringstilladelsen foreslog, og som blev godkendt af CHMP for anafylakse, var forenelig med den aktuelle CDS for Vascace Plus og gennemgangene af ACEhæmmere hos Meyler og Martindale.
English: • the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Vascace Plus and associated names (see Annex I).
Danish: • Produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen foreslog, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets videnskabelige drøftelse.
English: The CHMP requested the MAH to align this section with the harmonised Vascace SPC as far as ACEI component is concerned.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om at tilpasse dette punkt til det harmoniserede produktresumé for Vascace, for så vidt angår ACEI-komponenten.
English: Section 4.2 Posology and Method of Administration
Danish: Punkt 4.2 Dosering og indgivelsesmåde
English: The CHMP did not agree with the MAH's position.
Danish: CHMP var ikke enig i indehaveren af markedsføringstilladelsens holdning.
English: Anaphylaxis
Danish: Anafylakse
English: Section 4.8 Undesirable Effects
Danish: Afsnit 4.8.
English: 196 (2 x 98) capsules (multipack)
Danish: 196 (2 x 98) kapsler (multipakning)
English: CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES AND PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: KONKLUSIONER VED UDSTEDELSE AF MARKEDSFØRINGSTILLADELSEN UNDER SÆRLIGE OMSTÆNDIGHEDER OG FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.
Danish: Efter at have vurderet denne ansøgning er CHMP af den opfattelse, at risk/benefit-forholdet er positivt for anbefaling af udstedelse af en markedsføringstilladelse under særlige omstændigheder.
English: Conclusions presented by the European Medicines Agency on:
Danish: Konklusioner fremlagt af Det Europæiske Lægemiddelagentur vedrørende: • Markedsføringstilladelse under særlige omstændigheder
English: Should be avoided
Danish: Bør undgås
English: Adults (including elderly)
Danish: Voksne (herunder ældre)
English: Number of continent days per week
Danish: Antal kontinente dage pr. uge
English: Treatment should be symptomatic and supportive.
Danish: Behandlingen bør være symptomatisk og understøttende.
English: Date of first authorisation: 20 April 2007 Date of latest renewal: 15 March 2012
Danish: Dato for første markedsføringstilladelse: 20. april 2007 Dato for seneste fornyelse: 15. marts 2012
English: A total of 33% of patients were ≥65 years of age and 11% were ≥75 years of age.
Danish: I alt 33% af patienterne var ≥ 65 år og 11% var ≥ 75 år.
English: Therefore, you should brush your teeth regularly twice daily and see a dentist when in doubt.
Danish: Du bør derfor børste dine tænder regelmæssigt 2 gange dagligt og opsøge en tandlæge, hvis du er i tvivl.
English: Fesoterodine may not always be suitable for you.
Danish: Fesoterodin er måske ikke altid velegnet til dig.
English: # primary end points
Danish: # primære endepunkter
English: Full treatment effect was observed between 2 and 8 weeks.
Danish: Fuld behandlingseffekt blev set efter mellem 2 og 8 uger.
English: Responder rate (treatment response)#
Danish: Respondentrate (behandlingsrespons) #
English: TOVIAZ should be used with caution in patients with:
Danish: TOVIAZ bør anvendes med forsigtighed hos patienter med:
English: You should swallow your tablet whole with a glass of water.
Danish: Du skal sluge tabletten hel sammen med et glas vand.
English: Do not give this medicine to children and adolescents below 18 years of age because it is yet to be established whether it would work for them and whether it would be safe.
Danish: Du må ikke give dette lægemiddel til børn og unge under 18 år, da det endnu ikke er undersøgt om det virker på dem, og om det er sikkert.
English: Maximum plasma levels are reached after approximately 5 hours.
Danish: Der opnås maksimal plasmakoncentration efter cirka 5 timer.
English: No dose adjustment is recommended in these subpopulations.
Danish: Der anbefales ingen dosisjustering for disse underpopulationer.
English: Hence, it is recommended to reevaluate the efficacy for the individual patient after 8 weeks of treatment.
Danish: Det anbefales derfor, at virkningen hos den enkelte patient reevalueres efter 8 ugers behandling.
English: Treat symptoms as follows:
Danish: Symptomer behandles som følger:
English: Tablets are to be taken once daily with liquid and swallowed whole.
Danish: Tabletterne skal tages 1 gang dagligt sammen med væske og sluges hele.
English: Some side effects could be serious
Danish: Nogle bivirkninger kan blive alvorlige
English: Serious allergic reactions including angioedema occurred rarely.
Danish: Alvorlige allergiske reaktioner herunder angioødem ses sjældent.
English: The safety and efficacy of TOVIAZ in children below 18 years of age have not yet been established.
Danish: TOVIAZs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Bioavailability of the active metabolite is 52%.
Danish: Den aktive metabolits biotilgængelighed er 52%.
English: To help you remember to take your medicine, you may find it easier to take it at the same time every day.
Danish: Det kan måske hjælpe dig at huske at tage din medicin, hvis du tager den på samme tid hver dag.
English: Female (79%) and male (21%) patients with a mean age of 58 years (range 19-91 years) were included.
Danish: Undersøgelserne omfattede kvindelige (79%) og mandlige (21%) patienter med en gennemsnitsalder på 58 år (mellem 19-91 år).
English: Fesoterodine is a competitive, specific muscarinic receptor antagonist.
Danish: Fesoterodin er en kompetitiv, specifik muskarin-receptorantagonist.
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og på blisteren efter “EXP”.
English: Your doctor will tell you whether you can take TOVIAZ with other medicines.
Danish: Din læge vil fortælle dig, om du må tage TOVIAZ sammen med anden medicin.
English: Sealed pack Do not use if box has been opened
Danish: Forseglet pakning Må ikke anvendes, hvis pakningen har været åbnet
English: A dose reduction to 4 mg may be needed (see section 4.4).
Danish: Dosisreduktion til 4 mg kan blive nødvendig (se pkt.
English: This effect is usually mild or moderate.
Danish: Denne bivirkning er som regel let til moderat.
English: • an uncomfortable feeling in the stomach
Danish: • ubehagelig fornemmelse i maven
English: Organic causes must be excluded before any treatment with antimuscarinics is considered.
Danish: Organiske årsager skal udelukkes, før en behandling med antimuskarine lægemidler overvejes.
English: Women of child bearing potential should be made aware of the lack of human fertility data, and TOVIAZ should only be given after consideration of individual risks and benefits.
Danish: Kvinder i den fertile alder skal oplyses om de manglende data vedrørende fertilitet hos mennesker, og TOVIAZ bør kun gives efter overvejelse af individuelle risici og fordele.
English: Likewise, the response rate (% of patients reporting that their condition has been “greatly improved” or “improved” using a 4-point Treatment Benefit Scale) was significantly greater with fesoterodine compared to placebo.
Danish: Ligeså var responsraten (procentvis andel af patienter, som rapporterede, at deres tilstand var "meget forbedret" eller "forbedret" ved hjælp af en 4-punkts skala til vurdering af behandlingen) signifikant større med fesoterodin sammenlignet med placebo.
English: There are no adequate data from the use of fesoterodine in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af fesoterodin hos gravide kvinder.
English: The mean steady-state volume of distribution following intravenous infusion of the active metabolite is 169 l.
Danish: Gennemsnitlig steady-state for fordelingsvolumen efter intravenøs infusion af den aktive metabolit er 169 l.
English: Active comparator
Danish: Aktiv komparator
English: Contains lactose and soya lecithin: see the package leaflet for further information.
Danish: Indeholder lactose og sojalecithin: se indlægssedlen for yderligere information.
English: Safety and efficacy have not yet been established in patients with a neurogenic cause for detrusor overactivity.
Danish: Sikkerhed og virkning er endnu ikke fastlagt hos patienter med en neurogen årsag til detrusoroveraktivitet.
English: In the event of overdose, ECG monitoring is recommended; standard supportive measures for managing QT prolongation should be adopted.
Danish: I tilfælde af overdosering anbefales EKG-monitorering, og der bør træffes standardmæssige understøttende foranstaltninger til håndtering af QT-forlængelse.
English: ALT increased; GGT increased
Danish: Øget ALAT; øget GGT
English: The relation to fesoterodine treatment is unclear.
Danish: Sammenhængen med fesoterodinbehandlingen er uklar.
English: Baseline Change from baseline p-value
Danish: Ændring fra baseline p-værdi
English: The adverse reactions are reported in this table with the following frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000).
Danish: Bivirkningerne er anført i denne tabel, og frekvenser er defineret som følger: meget almindelige (≥ 1/10), almindelige (≥ 1/100 til < 1/10), ikke almindelige (≥ 1/1.000 til < 1/100), sjælden (≥ 1/1.0000 til < 1/1.000).
English: No accumulation occurs after multiple-dose administration.
Danish: Der forekommer ingen akkumulation efter administration af flere doser.
English: The clinical relevance of these findings will depend on individual patient risk factors and susceptibilities present (see section 4.4).
Danish: Den kliniske relevans af disse resultater afhænger af den enkelte patients risikofaktorer og følsomhed (se pkt.
English: Furthermore, fesoterodine improved the mean change in the voided volume per micturition, and the mean change in the number of continent days per week (see Table 1 below).
Danish: Desuden forbedrede fesoterodin den gennemsnitlige ændring i den udtømte mængde pr. vandladning, og den gennemsnitlige ændring i antallet af kontinente dage pr. uge (se Tabel 1 nedenfor).
English: TOVIAZ can be taken with or without food.
Danish: TOVIAZ kan tages med eller uden mad.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: TOVIAZ is not recommended during pregnancy.
Danish: TOVIAZ bør ikke bruges under graviditet.