natgillin/translations-raw huggingface dataset:
Klinikere skal være opmærksomme på mulig fremkomst af alvorlige neuropsykiatriske symptomer hos patienter, der prøver at stoppe med at ryge med eller uden behandling.
Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with or without treatment.
Farmakokinetik i særlige patientpopulationer
Pharmacokinetics in special patient populations
Rygeophørsraterne i denne population var sammenlignelig med den generelle population.
The cessation rates in this population were similar to those reported in the general population.
Sikkerhedsprofilen for vareniclin var sammenlignelig med den, der blev set i andre kliniske studier i den generelle population, inklusive lungesikkerhed.
The safety profile of varenicline was comparable to what was reported in other trials in the general population, including pulmonary safety.
Baseret på indberetninger efter markedsføringen kan bupropion være forbundet med neuropsykiatriske bivirkninger.
Based on post marketing reports, bupropion may be associated with neuropsychiatric adverse events.
Under opfølgning
During follow up
Der foreligger kun begrænsede kliniske data om potentielle interaktioner mellem alkohol og vareniclin.
There are limited clinical data on any potential interaction between alcohol and varenicline.
I tilfælde af overdosering anbefales understøttende behandling efter behov.
In case of overdose, standard supportive measures should be instituted as required.
CHAMPIX kan tages med eller uden mad.
CHAMPIX can be taken with or without food
Nicotin konkurrerer om det samme humane α4β2 nAChR bindingssted, for hvilket vareniclin har højere affinitet.
Nicotine competes for the same human α4β2 nAChR binding site for which varenicline has higher affinity.
Halveringstiden for vareniclin er cirka 24 timer.
The elimination half-life of varenicline is approximately 24 hours.
Vareniclins plasmaproteinbinding er lav (20%), og den er uafhængig af både alder og nyrefunktion.
Plasma protein binding of varenicline is low (< 20%) and independent of both age and renal function.
# (RR; 95% CI) * Af disse rapporterede en patient i hver behandlingsarm om selvmordsadfærd ** Patienter med hændelser op til 30 dage efter behandlingen; % er ikke vægtet for hvert studie # RR af incidensrater for hver 100 patientår
* Of these, one patient in each treatment arm reported suicidal behaviour ** Patients with events up to 30 days after treatment; % are not weighted by study # RR of incidence rates per 100 patient years
Patienterne i dette studie (n=1.927) modtog CHAMPIX open-label 1 mg 2 gange dagligt i 12 uger.
Patients in this study (n=1,927) received open-label CHAMPIX 1 mg twice daily for 12 weeks.
Hazard ratio for MACE var højere hos patienter med kardiovaskulære risikofaktorer sammen med rygning end hos patienter uden andre kardiovaskulære risikofaktorer end rygning.
The hazard ratio for MACE was higher in patients with cardiovascular risk factors in addition to smoking compared with that in patients without cardiovascular risk factors other than smoking.
Der bør udvises forsigtighed ved patienter med tidligere psykisk sygdom, og patienter bør rådgives i henhold hertil.
Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly.
Det primære endepunkt for CHAMPIX viste statistisk overlegenhed over for bupropion og placebo.
The primary endpoint for CHAMPIX demonstrated statistical superiority to bupropion and placebo.
Må ikke anvendes, hvis kartonen har været åbnet.
Do not use if box has been opened.
Følgende P450-enzymer er undersøgt for hæmning: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4/5.
The P450 enzymes tested for inhibition were: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5.
1 ydre karton indeholdende:
One outer carton containing:
Vægtstigning, nedsat appetit, øget appetit Hyperglykæmi
Weight increased, decreased appetite, increased appetite Hyperglycaemia
Alle studier var retrospektive kohortestudier og inkluderede patienter med og uden psykiatriske lidelser i anamnesen.
All studies were retrospective cohort studies and included patients with and without a psychiatric history.
Patienter, der ikke ønsker eller er ude af stand til at fastsætte en ophørsdato inden for 1-2 uger, bør tilbydes, at påbegynde behandlingen og derefter vælge deres egen ophørsdato inden for 5 uger.
Patients who are not willing or able to set the target quit date within 1-2 weeks, could be offered to start treatment and then choose their own quit date within 5 weeks.
Med blå boks
Contains Blue Box
Virkning og sikkerhed af vareniclin er blevet undersøgt hos rygere, der havde muligheden for at holde op med at ryge mellem uge 1 og 5 af behandlingen.
The efficacy and safety of varenicline has been evaluated in smokers who had the flexibility of quitting between weeks 1 and 5 of treatment.
Tabellen nedenunder beskriver de hyppigst (< 1%) rapporterede kategorier af bivirkninger, der vedrører psykiatrisk sikkerhed, med undtagelse af søvnlidelser og søvnforstyrrelser.
The table below describes the most frequently (≥ 1%) reported categories of adverse events related to psychiatric safety other than sleep disorders and disturbances.
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.
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.
Nogle af patienterne, der havde behov for koronar revaskularisering, blev opereret som led i behandling af non-letal myokardieinfarkt og hospitalsindlæggelse for angina.
Some of the patients requiring coronary revascularisation underwent the procedure as part of management of nonfatal MI and hospitalisation for angina.
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.
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.
De vigtigste effektresultater er opsummeret i følgende tabel:
The key efficacy results are summarised in the following table:
Sikkerhed og effekt af CHAMPIX i kombination med andre typer rygeophør er ikke undersøgt.
Safety and efficacy of CHAMPIX in combination with other smoking cessation therapies have not been studied.
Samtidig administration af cimetidin og vareniclin øger den systemiske eksponering af vareniclin med 29% på grund af nedsat renal clearance af vareniclin.
Co-administration of cimetidine, with varenicline increased the systemic exposure of varenicline by 29% due to a reduction in varenicline renal clearance.
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.
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.
Selv om det ikke har været undersøgt, kan CHAMPIX udskilles i mælk.
Although it was not studied, CHAMPIX may pass into breast milk.
Renal elimination af vareniclin sker fortrinsvis ved glomerulær filtration samt ved aktiv tubulær sekretion via organiske kationtransporter, OCT2 (se pkt.
Renal elimination of varenicline is primarily through glomerular filtration along with active tubular secretion via the organic cationic transporter, OCT2 (see section 4.5).
Vareniclin metaboliseres minimalt og 92% udskilles uomdannet med urinen og mindre end 10% udskilles som metabolitter.
Varenicline undergoes minimal metabolism with 92% excreted unchanged in the urine and less than 10% excreted as metabolites.
ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
UNIQUE IDENTIFIER - HUMAN READABLE DATA Not Applicable
Effekten af CHAMPIX til rygeophør er vist i 3 kliniske studier med kroniske cigaretrygere (≥10 cigaretter per dag).
The efficacy of CHAMPIX in smoking cessation was demonstrated in 3 clinical trials involving chronic cigarette smokers ( 10 cigarettes per day).
Uge 1 Uge 2-4
Week 1 Week 2-4
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.
A gradual approach to quitting smoking with CHAMPIX should be considered for patients who are not able or willing to quit abruptly.
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.
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.
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.
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.
Det er derfor usandsynligt, at aktive stoffer, der elimineres ved renal udskillelse (f.eks. metformin - se nedenfor) påvirkes af vareniclin.
Therefore, active substances that are cleared by renal secretion (e.g., metformin - see below) are unlikely to be affected by varenicline.
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.
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.
Uge 3 - 12 Dosis Dag 15behandlingen er slut
Weeks 3 - 12 Day 15end of treatment
CHAMPIX-tabletter bør sluges hele med vand og kan tages både med og uden mad.
The tablets should be swallowed whole with water and can be taken with or without food.
Se afsnittet ”Brug af anden medicin sammen med CHAMPIX” nedenfor for detaljer.
See below under ‘Other medicines and CHAMPIX' for further details.
Ikke-psykiatrisk kohorte
Non-psychiatric Cohort
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.
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.
Antal behandlede patienter
Number of Patients
Det primære sikkerhedsendepunkt var en sammensætning af neuropsykiatriske bivirkninger, der er indberettet efter markedsføring.
The primary safety endpoint was a composite of neuropsychiatric adverse events that have been reported in post-marketing experience.
Der er ikke indberettet tilfælde af overdosering i kliniske studier før markedsføring.
No cases of overdose were reported in pre-marketing clinical trials.
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.
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.
Hvis De har problemer med nyrerne, skal De tale med Deres læge, inden De tager CHAMPIX.
If you have problems with your kidneys, you should speak to your doctor before taking CHAMPIX.
Studie 2 (n=1023) 4W-CQR CA Uge 9-52 4W-CQR CA Uge 9-52
Study 2 (n=1023) 4W CQR CA Wk 9-52 4W CQR CA Wk 9-52
Fortæl det til lægen, hvis De oplever ændring i Deres symptomer under behandlingen med CHAMPIX.
Tell your doctor if you have any changes in symptoms during treatment with CHAMPIX.
Sikkerhedsprofilen for CHAMPIX i dette studie var i overensstemmelse med den sikkerhedsprofil, der blev set i studierne forud for markedsføringen.
The CHAMPIX safety profile in this study was consistent with that of pre-marketing studies.
- hvis De er allergisk over for vareniclin eller et af de øvrige indholdsstoffer i CHAMPIX (angivet i afsnit 6).
If you are allergic to varenicline or any of the other ingredients of this medicine (listed in section 6)
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.
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.
Ikke kendt
Rare Not known
Nye tilfælde af eller forværring af eksisterende hjerte-karsygdomme er hovedsagelig set hos patienter, der allerede har hjerte-karsygdomme.
New or worse heart or blood vessel (cardiovascular) problems have been reported primarily in people who already have cardiovascular problems.
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.
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.
Patienterne skal reducere rygningen i løbet af de første 12 ugers behandling og stoppe med at ryge ved afslutningen af denne behandlingsperiode.
Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period.
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.
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.
Under behandling plus 30 dage MACE, n (%)
During treatment plus 30 days MACE, n (%)
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.
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.
CHAMPIX er medicin, som bruges til at hjælpe voksne med at holde op med at ryge.
CHAMPIX is a medicine which is used in adults to help them stop smoking.
Nedtrykthed, dog sjældent med selvmordstanker eller selvmordsforsøg, kan være en følge af nikotinophør.
Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal.
CHAMPIX bør anvendes med forsigtighed hos patienter med kramper i anamnesen eller andre forhold, der potentielt kan sænke krampetærsklen.
CHAMPIX should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
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).
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).
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.
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.
En moderat mængde data fra gravide kvinder indikerede ingen misdannelser eller føtal/neonatal toksicitet af vareniclin (se pkt.
A moderate amount of data on pregnant women indicated no malformative or foetal/neonatal toxicity of varenicline (see section 5.1).
Der forekom ét gennemført selvmord under behandlingen af en forsøgsperson, der blev behandlet med placebo i den ikke-psykiatriske kohorte.
There was one completed suicide, which occurred during treatment in a subject treated with placebo in the non-psychiatric cohort.
Dosis bør begynde med 0,5 mg 1 gang dagligt i de første 3 dage og derefter øges til 1 mg 1 gang dagligt.
Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily.
I studier med mennesker viste vareniclin et lavt misbrugspotentiale.
In clinical studies in humans, varenicline showed low abuse potential.
De forudspecificerede statistiske testprocedurer stoppede testningen, efter at sammenligningen af behandling med højdosis-vareniclin vs. placebo i det overordende studie ikke opnåede statistisk signifikans.
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.
Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Derfor kan det nogen gange være nødvendigt at ændre dosis af anden medicin.
Therefore, in some cases an adjustment of the dose may be necessary.
Der blev ikke rapporteret nogen gennemførte selvmord i den psykiatriske kohorte.
There were no completed suicides reported in the psychiatric cohort.
På baggrund af vareniclins karakteristika og den hidtidige kliniske erfaring har CHAMPIX ingen lægemiddelinteraktioner af klinisk betydning.
Based on varenicline characteristics and clinical experience to date, CHAMPIX has no clinically meaningful drug interactions.
CHAMPIX er indiceret til rygeophør hos voksne.
CHAMPIX is indicated for smoking cessation in adults.
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.
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.
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.
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.
Psykiatrisk kohorte
Psychiatric Cohort
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.
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.
*CA: Vedvarende afholdenhedsrate (continuous abstinence rate)
*CA: Continuous Abstinence Rate
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.
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.
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.
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.
En meta-analyse af 18 dobbelt-blinde, randomiserede, placebokontrollerede kliniske studier blev udført for at vurdere vareniclins neuropsykiatriske sikkerhed.
A meta-analysis of 18 double-blind, randomised, placebo-controlled clinical trials was conducted to assess the neuropsychiatric safety of varenicline.
CHAMPIX kan også nedsætte nydelsen ved cigaretter, hvis De alligevel ryger under behandlingen.
CHAMPIX can also reduce the enjoyment of cigarettes if you do smoke when on treatment.
Rygeophør er, hvad enten det gennemføres med eller uden behandling, forbundet med forskellige symptomer.
Smoking cessation with or without treatment is associated with various symptoms.
Bronkitis, sinuitis
Bronchitis, sinusitis
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).
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).
CHAMPIX fås som en hvid tablet (0,5 mg) og en lyseblå tablet (1 mg).
CHAMPIX comes as a white tablet (0.5 mg) and a light blue tablet (1 mg).
In vitro-forsøg viser, at vareniclin ikke hæmmer CYP450-enzymer (IC50>6.400 ng/ml).
In vitro studies demonstrate that varenicline does not inhibit cytochrome P450 enzymes (IC50 > 6,400 ng/ml).
Der blev ikke set forværring af skizofreni i nogen af behandlingsgrupperne målt efter psykiatriske skalaer, og der var ingen ændring i ekstrapyramidale tegn.
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.
Efter 40 uger uden behandling er det vigtigste sekundære endepunkt for begge kliniske studier den vedvarende afholdenhedsrate (Continuous Abstinence Rate, CA) ved uge 52.
After the 40 week non-treatment phase, a key secondary endpoint for both studies was the Continuous Abstinence Rate (CA) at week 52.
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.
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.
De kan opleve midlertidig irritabilitet, rygetrang, depression og/eller søvnforstyrrelse, når De holder op med at tage CHAMPIX.
You may temporarily experience increased irritability, urge to smoke, depression and/or sleep disturbances when you stop taking CHAMPIX.