FrancophonIA/ELRC3.0 huggingface dataset:
English: The table below describes the most frequently (≥ 1%) reported categories of adverse events related to psychiatric safety other than sleep disorders and disturbances.
Danish: Tabellen nedenunder beskriver de hyppigst (< 1%) rapporterede kategorier af bivirkninger, der vedrører psykiatrisk sikkerhed, med undtagelse af søvnlidelser og søvnforstyrrelser.
English: Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medicinal product affects their ability to perform these activities.
Danish: Patienter opfordres til ikke at føre bil, betjene komplekse maskiner eller deltage i andre potentielt farlige aktiviteter, før det er afklaret, om dette lægemiddel påvirker deres evne til at udføre disse aktiviteter.
English: Some of the patients requiring coronary revascularisation underwent the procedure as part of management of nonfatal MI and hospitalisation for angina.
Danish: Nogle af patienterne, der havde behov for koronar revaskularisering, blev opereret som led i behandling af non-letal myokardieinfarkt og hospitalsindlæggelse for angina.
English: This meta-analysis included one trial (N=127) in patients with a history of schizophrenia or schizoaffective disorder and another trial (N=525) in patients with a history of depression.
Danish: Denne meta-analyse omfattede et studie (n=127) med patienter med skizofreni eller skizoaffektiv lidelse i anamnesen og et andet studie (n=525) med patienter med depression i anamnesen.
English: The key efficacy results are summarised in the following table:
Danish: De vigtigste effektresultater er opsummeret i følgende tabel:
English: Safety and efficacy of CHAMPIX in combination with other smoking cessation therapies have not been studied.
Danish: Sikkerhed og effekt af CHAMPIX i kombination med andre typer rygeophør er ikke undersøgt.
English: Co-administration of cimetidine, with varenicline increased the systemic exposure of varenicline by 29% due to a reduction in varenicline renal clearance.
Danish: Samtidig administration af cimetidin og vareniclin øger den systemiske eksponering af vareniclin med 29% på grund af nedsat renal clearance af vareniclin.
English: Subjects were instructed to reduce the number of cigarettes smoked by at least 50 percent by the end of the first four weeks of treatment, followed by a further 50 percent reduction from week four to week eight of treatment, with the goal of reaching complete abstinence by 12 weeks.
Danish: Forsøgspersonerne blev instrueret i at reducere antallet af cigaretter med mindst 50% ved afslutningen af de første fire behandlingsuger og derefter med yderligere 50% fra behandlingens uge 4 til 8 med fuldstændig afholdenhed som mål efter 12 uger.
English: Although it was not studied, CHAMPIX may pass into breast milk.
Danish: Selv om det ikke har været undersøgt, kan CHAMPIX udskilles i mælk.
English: Renal elimination of varenicline is primarily through glomerular filtration along with active tubular secretion via the organic cationic transporter, OCT2 (see section 4.5).
Danish: Renal elimination af vareniclin sker fortrinsvis ved glomerulær filtration samt ved aktiv tubulær sekretion via organiske kationtransporter, OCT2 (se pkt.
English: Varenicline undergoes minimal metabolism with 92% excreted unchanged in the urine and less than 10% excreted as metabolites.
Danish: Vareniclin metaboliseres minimalt og 92% udskilles uomdannet med urinen og mindre end 10% udskilles som metabolitter.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not Applicable
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: The efficacy of CHAMPIX in smoking cessation was demonstrated in 3 clinical trials involving chronic cigarette smokers ( 10 cigarettes per day).
Danish: Effekten af CHAMPIX til rygeophør er vist i 3 kliniske studier med kroniske cigaretrygere (≥10 cigaretter per dag).
English: Week 1 Week 2-4
Danish: Uge 1 Uge 2-4
English: A gradual approach to quitting smoking with CHAMPIX should be considered for patients who are not able or willing to quit abruptly.
Danish: En gradvis metode til at stoppe med at ryge ved hjælp af CHAMPIX bør overvejes for patienter, som ikke kan eller vil stoppe på én gang.
English: Patients included in this study had taken CHAMPIX for a smoking-cessation attempt in the past (for a total treatment duration of a minimum of two weeks), at least three months prior to study entry, and had been smoking for at least four weeks.
Danish: Patienter inkluderet i dette studie havde tidligere taget CHAMPIX for at prøve at stoppe med at ryge (i en samlet behandlingsvarighed på mindst to uger) mindst tre måneder før inklusion i studiet og havde røget i mindst fire uger.
English: CI=confidence interval; N=number of subjects randomised; n=the number of subjects who, at each visit from weeks 9 to 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and at any of these visits were confirmed to have quit based on urine cotinine test.
Danish: CI = konfidensinterval; N = antal randomiserede forsøgsdeltagere; n = antal forsøgsdeltagere, som ved hvert besøg fra uge 9 til 12 (inklusive) rapporterede 'ingen rygning' og 'ingen brug af andre nikotinholdige produkter siden sidste studiebesøg/sidste kontakt' (på opgørelsen over nikotinforbrug), og hos hvem ophøret blev bekræftet på baggrund af urintest for cotinin.
English: Therefore, active substances that are cleared by renal secretion (e.g., metformin - see below) are unlikely to be affected by varenicline.
Danish: Det er derfor usandsynligt, at aktive stoffer, der elimineres ved renal udskillelse (f.eks. metformin - se nedenfor) påvirkes af vareniclin.
English: The following table from the above paediatric study shows a comparison of continuous abstinence rates (CAR) from weeks 9-12, confirmed by urine cotinine test, for the full analysis set overall study population and the 12-17 year old population.
Danish: Nedenstående tabel fra ovennævnte pædiatriske studie viser en sammenligning af vedvarende afholdenhedsrater (continuous abstinence rates (CAR)) fra uge 9-12 (bekræftet ved urintest for cotinin) for hele analysesættets samlede studiepopulation og populationen i alderen 12-17 år.
English: Weeks 3 - 12 Day 15end of treatment
Danish: Uge 3 - 12 Dosis Dag 15behandlingen er slut
English: The tablets should be swallowed whole with water and can be taken with or without food.
Danish: CHAMPIX-tabletter bør sluges hele med vand og kan tages både med og uden mad.
English: See below under ‘Other medicines and CHAMPIX' for further details.
Danish: Se afsnittet ”Brug af anden medicin sammen med CHAMPIX” nedenfor for detaljer.
English: Non-psychiatric Cohort
Danish: Ikke-psykiatrisk kohorte
English: Cardiovascular death occurred in 0.3% of patients in the CHAMPIX arm and 0.6% of patients in the placebo arm over the course of the 52-week study.
Danish: Kardiovaskulær død blev set hos 0,3% af patienterne i CHAMPIX-armen og hos 0,6% af patienterne i placebo-armen i løbet af det 52 uger lange studie.
English: Number of Patients
Danish: Antal behandlede patienter
English: The primary safety endpoint was a composite of neuropsychiatric adverse events that have been reported in post-marketing experience.
Danish: Det primære sikkerhedsendepunkt var en sammensætning af neuropsykiatriske bivirkninger, der er indberettet efter markedsføring.
English: No cases of overdose were reported in pre-marketing clinical trials.
Danish: Der er ikke indberettet tilfælde af overdosering i kliniske studier før markedsføring.
English: You should not drive, operate complex machinery or engage in any other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Danish: De bør derfor ikke køre bil, betjene maskiner eller deltage i andre potentielt farlige aktiviteter, før det er afklaret om, denne medicin påvirker Deres evne til at udføre disse aktiviteter.
English: If you have problems with your kidneys, you should speak to your doctor before taking CHAMPIX.
Danish: Hvis De har problemer med nyrerne, skal De tale med Deres læge, inden De tager CHAMPIX.
English: Study 2 (n=1023) 4W CQR CA Wk 9-52 4W CQR CA Wk 9-52
Danish: Studie 2 (n=1023) 4W-CQR CA Uge 9-52 4W-CQR CA Uge 9-52
English: Tell your doctor if you have any changes in symptoms during treatment with CHAMPIX.
Danish: Fortæl det til lægen, hvis De oplever ændring i Deres symptomer under behandlingen med CHAMPIX.
English: The CHAMPIX safety profile in this study was consistent with that of pre-marketing studies.
Danish: Sikkerhedsprofilen for CHAMPIX i dette studie var i overensstemmelse med den sikkerhedsprofil, der blev set i studierne forud for markedsføringen.
English: If you are allergic to varenicline or any of the other ingredients of this medicine (listed in section 6)
Danish: - hvis De er allergisk over for vareniclin eller et af de øvrige indholdsstoffer i CHAMPIX (angivet i afsnit 6).
English: Psychiatric scales showed no differences between the varenicline and placebo groups and no overall worsening of depression, or other psychiatric symptoms, during the study in either treatment group.
Danish: De psykiatriske skalaer viste ingen forskel mellem vareniclin- og placebo-grupperne, og samlet set var der ingen forværring af depression eller andre psykiatriske symptomer i løbet af studiet i nogen af behandlingsgrupperne.
English: Rare Not known
Danish: Ikke kendt
English: New or worse heart or blood vessel (cardiovascular) problems have been reported primarily in people who already have cardiovascular problems.
Danish: Nye tilfælde af eller forværring af eksisterende hjerte-karsygdomme er hovedsagelig set hos patienter, der allerede har hjerte-karsygdomme.
English: The following table shows the incidence of MACE and Hazard Ratios vs placebo for all treatment groups during treatment, and cumulative for treatment plus 30 days and through end of study.
Danish: Nedenstående skema viser forekomsten af MACE og Hazard ratio sammenlignet med placebo for alle behandlingsgrupper under behandling og kumulativt for behandling plus 30 dage og til og med studiets afslutning.
English: Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period.
Danish: Patienterne skal reducere rygningen i løbet af de første 12 ugers behandling og stoppe med at ryge ved afslutningen af denne behandlingsperiode.
English: For some people, stopping smoking with or without treatment has been associated with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety and can be associated with a worsening of psychiatric disorder.
Danish: Hos nogle personer kan rygeophør, hvad enten det gennemføres med eller uden behandling, være forbundet med en øget risiko for, at man oplever ændringer i adfærd eller tankegang, og at man føler sig deprimeret eller angst og kan være forbundet med forværring af psykiske forstyrrelser.
English: During treatment plus 30 days MACE, n (%)
Danish: Under behandling plus 30 dage MACE, n (%)
English: If you have severe kidney disease you should avoid taking cimetidine (a medicine used for gastric problems) at the same time as CHAMPIX as this may cause increased blood levels of CHAMPIX.
Danish: Hvis De har alvorlig nyresygdom, skal De undgå at tage cimetidin (medicin mod for meget mavesyre) samtidig med CHAMPIX, da dette kan øge indholdet af CHAMPIX i blodet.
English: CHAMPIX is a medicine which is used in adults to help them stop smoking.
Danish: CHAMPIX er medicin, som bruges til at hjælpe voksne med at holde op med at ryge.
English: Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal.
Danish: Nedtrykthed, dog sjældent med selvmordstanker eller selvmordsforsøg, kan være en følge af nikotinophør.
English: CHAMPIX should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Danish: CHAMPIX bør anvendes med forsigtighed hos patienter med kramper i anamnesen eller andre forhold, der potentielt kan sænke krampetærsklen.
English: The occurrence of detected suicide was rare during the three months after patients initiated any drug treatment (two cases in 31,260 varenicline users and six cases in 81,545 NRT users).
Danish: Konstateret selvmord var sjældent i løbet af de første tre måneder efter, at patienterne påbegyndte en hvilken som helst lægemiddelbehandling (to tilfælde blandt 31.260 vareniclinbrugere og seks tilfælde blandt 81.545 nicotinsubstitionsbrugere).
English: Of the 55 patients who reported suicidal ideation or behaviour, 48 (24 varenicline, 24 placebo) were from the two trials that enrolled patients with a history of schizophrenia/ schizoaffective disorder, or of depression.
Danish: Af de 55 patienter, der rapporterede om selvmordstanker eller -adfærd, var 48 (24 vareniclin og 24 placebo) fra de to studier, der inkluderede patienter med skizofreni/skizoaffektiv lidelse eller depression i anamnesen.
English: A moderate amount of data on pregnant women indicated no malformative or foetal/neonatal toxicity of varenicline (see section 5.1).
Danish: En moderat mængde data fra gravide kvinder indikerede ingen misdannelser eller føtal/neonatal toksicitet af vareniclin (se pkt.
English: There was one completed suicide, which occurred during treatment in a subject treated with placebo in the non-psychiatric cohort.
Danish: Der forekom ét gennemført selvmord under behandlingen af en forsøgsperson, der blev behandlet med placebo i den ikke-psykiatriske kohorte.
English: Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily.
Danish: Dosis bør begynde med 0,5 mg 1 gang dagligt i de første 3 dage og derefter øges til 1 mg 1 gang dagligt.
English: In clinical studies in humans, varenicline showed low abuse potential.
Danish: I studier med mennesker viste vareniclin et lavt misbrugspotentiale.
English: The prespecified statistical testing procedures stopped testing after the high-dose varenicline vs Placebo treatment comparison in the overall study did not achieve statistical significance.
Danish: De forudspecificerede statistiske testprocedurer stoppede testningen, efter at sammenligningen af behandling med højdosis-vareniclin vs. placebo i det overordende studie ikke opnåede statistisk signifikans.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Therefore, in some cases an adjustment of the dose may be necessary.
Danish: Derfor kan det nogen gange være nødvendigt at ændre dosis af anden medicin.
English: There were no completed suicides reported in the psychiatric cohort.
Danish: Der blev ikke rapporteret nogen gennemførte selvmord i den psykiatriske kohorte.
English: Based on varenicline characteristics and clinical experience to date, CHAMPIX has no clinically meaningful drug interactions.
Danish: På baggrund af vareniclins karakteristika og den hidtidige kliniske erfaring har CHAMPIX ingen lægemiddelinteraktioner af klinisk betydning.
English: CHAMPIX is indicated for smoking cessation in adults.
Danish: CHAMPIX er indiceret til rygeophør hos voksne.
English: If you are not able or willing to quit smoking straight away, you should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period.
Danish: Hvis De ikke kan eller vil stoppe med at ryge lige på én gang, skal De nedsætte rygningen i løbet af de første 12 ugers behandling og stoppe helt ved afslutningen af denne behandlingsperiode.
English: CHAMPIX was evaluated in a 52-week double-blind placebo-controlled study of 1,510 subjects who were not able or willing to quit smoking within four weeks, but were willing to gradually reduce their smoking over a 12 week period before quitting.
Danish: CHAMPIX blev evalueret i et 52 ugers dobbelt-blindet, placebokontrolleret studie med 1.510 forsøgspersoner, der ikke kunne eller ville stoppe med at ryge inden for fire uger, men som var villige til at reducere deres rygning gradvist i løbet af en periode på 12 uger, før de holdt helt op med at ryge.
English: Psychiatric Cohort
Danish: Psykiatrisk kohorte
English: When varenicline and transdermal NRT were co-administered to smokers for 12 days, there was a statistically significant decrease in average systolic blood pressure (mean 2.6 mmHg) measured on the final day of the study.
Danish: Når vareniclin og transdermal nicotinsubstitution blev anvendt samtidigt hos rygere i 12 dage, var der et statistisk signifikant fald i det gennemsnitlige systoliske blodtryk (gennemsnitligt 2,6 mmHg) målt på den sidste dag i undersøgelsen.
English: *CA: Continuous Abstinence Rate
Danish: *CA: Vedvarende afholdenhedsrate (continuous abstinence rate)
English: The rates of events in the composite endpoint were low across all treatment groups and were similar or lower for each of the active treatments compared to placebo.
Danish: Hyppigheden af hændelser i det sammensatte endepunkt var lav for alle behandlingsgrupper og var identiske med eller lavere for hver af de aktive behandlinger sammenlignet med placebo.
English: Of all subjects treated in the parent study, 1749 (21.7%) had a medium CV risk and 644 (8.0%) had a high CV risk, as defined by Framingham score.
Danish: Af alle de forsøgspersoner, som blev behandlet i hovedstudiet, havde 1749 (21,7 %) en middel kardiovaskulær risiko, og 644 (8,0 %) havde en høj kardiovaskulær risiko som defineret iht.
English: A meta-analysis of 18 double-blind, randomised, placebo-controlled clinical trials was conducted to assess the neuropsychiatric safety of varenicline.
Danish: En meta-analyse af 18 dobbelt-blinde, randomiserede, placebokontrollerede kliniske studier blev udført for at vurdere vareniclins neuropsykiatriske sikkerhed.
English: CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke when on treatment.
Danish: CHAMPIX kan også nedsætte nydelsen ved cigaretter, hvis De alligevel ryger under behandlingen.
English: Smoking cessation with or without treatment is associated with various symptoms.
Danish: Rygeophør er, hvad enten det gennemføres med eller uden behandling, forbundet med forskellige symptomer.
English: Bronchitis, sinusitis
Danish: Bronkitis, sinuitis
English: A population-based cohort study compared infants exposed to CHAMPIX in utero (N=335) with infants born to mothers who smoked during pregnancy (N=78,412) and infants born to non-smoking mothers (N=806,438).
Danish: Et populationsbaseret kohortestudie sammenlignede spædbørn, som var blevet eksponeret for CHAMPIX in utero (N=335), med spædbørn født af mødre som røg under graviditeten (N=78.412), og spædbørn født af mødre som ikke røg (N=806.438).
English: CHAMPIX comes as a white tablet (0.5 mg) and a light blue tablet (1 mg).
Danish: CHAMPIX fås som en hvid tablet (0,5 mg) og en lyseblå tablet (1 mg).
English: In vitro studies demonstrate that varenicline does not inhibit cytochrome P450 enzymes (IC50 > 6,400 ng/ml).
Danish: In vitro-forsøg viser, at vareniclin ikke hæmmer CYP450-enzymer (IC50>6.400 ng/ml).
English: Overall, there was no worsening of schizophrenia in either treatment group as measured by psychiatric scales and there were no overall changes in extra-pyramidal signs.
Danish: Der blev ikke set forværring af skizofreni i nogen af behandlingsgrupperne målt efter psykiatriske skalaer, og der var ingen ændring i ekstrapyramidale tegn.
English: After the 40 week non-treatment phase, a key secondary endpoint for both studies was the Continuous Abstinence Rate (CA) at week 52.
Danish: Efter 40 uger uden behandling er det vigtigste sekundære endepunkt for begge kliniske studier den vedvarende afholdenhedsrate (Continuous Abstinence Rate, CA) ved uge 52.
English: Steady-state systemic exposure in adolescent patients of bodyweight > 55 kg, as assessed by AUC (0-24), was comparable to that noted for the same doses in the adult population.
Danish: Det systemiske niveau ved steady-state hos unge med legemsvægt >55 kg, vurderet ved AUC(0-24), var sammenligneligt med hvad der er set for samme doser hos voksne.
English: You may temporarily experience increased irritability, urge to smoke, depression and/or sleep disturbances when you stop taking CHAMPIX.
Danish: De kan opleve midlertidig irritabilitet, rygetrang, depression og/eller søvnforstyrrelse, når De holder op med at tage CHAMPIX.
English: All studies used statistical methods to control for confounding factors, including preferential prescribing of varenicline to healthier patients, although there is the possibility of residual confounding.
Danish: Alle studier anvendte statistiske metoder til kontrol af forstyrrende faktorer (counfounders), herunder ordinering baseret på præference for ordination af vareniclin til mere raske patienter, selvom der er en mulighed for, at korrektionen ikke har været helt effektiv (residual confounding).
English: Smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e.g. depression).
Danish: Rygestop, med eller uden farmakoterapi, har været forbundet med eksacerbation af underliggende psykisk sygdom (f.eks. depression).
English: If you have a history of psychiatric disorder you should discuss this with your doctor.
Danish: Hvis De tidligere har lidt af en psykisk forstyrrelse, bør De tale med lægen om det.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 September 2006
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Comparative clinical studies
Danish: Sammenlignende kliniske studier
English: Deaths and serious cardiovascular events were adjudicated by a blinded, committee.
Danish: Dødsfald og alvorlige kardiovaskulære hændelser blev vurderet af en blindet komite.
English: Varenicline exhibits linear kinetics when given as single (0.1 to 3 mg) or repeated 1 to 3 mg/day doses.
Danish: Vareniclin udviser lineær kinetik, når det gives som enkeltdoser (0,1 mg til 3 mg) eller som gentagne doser 1 mg til 3 mg per dag.
English: Clinical signs included swelling of the face, mouth (tongue, lips, and gums), neck (throat and larynx) and extremities.
Danish: Kliniske symptomer som hævelser i ansigtet, munden (tunge, læber og gummer), halsen (svælget og larynx) og ekstremiteterne.
English: In vitro studies demonstrate that varenicline does not inhibit human renal transport proteins at therapeutic concentrations.
Danish: In vitro-forsøg viser, at vareniclin ikke hæmmer human renal transport-proteiner ved terapeutiske koncentrationer.
English: Analyses of Clinical Trials:
Danish: Analyser af kliniske studier:
English: Treatment Comparisons
Danish: Behandlingssammenligning
English: Physiological changes resulting from smoking cessation, with or without treatment with CHAMPIX, may alter the pharmacokinetics or pharmacodynamics of some medicinal products, for which dosage adjustment may be necessary (examples include theophylline, warfarin and insulin).
Danish: De fysiologiske ændringer, som rygeophør forårsager, hvad enten det gennemføres med eller uden CHAMPIX, kan ændre farmakokinetikken eller farmakodynamikken af visse lægemidler (f.eks. theofylin, warfarin og insulin).
English: As these skin reactions can be life threatening, patients should discontinue treatment at the first sign of rash or skin reaction and contact a healthcare provider immediately.
Danish: Da disse hudreaktioner kan være livstruende, skal patienter seponere behandlingen ved det første tegn på udslæt eller hudreaktion og straks kontakte lægen.
English: Neuropsychiatric symptoms
Danish: Neuropsykiatriske symptomer