FrancophonIA/ELRC3.0 huggingface dataset:
English: 18 placebo-controlled pre- and post-marketing studies, including approximately 5,000 patients treated with varenicline.
Danish: poolede data fra 18 placebokontrollerede studier (udført både før og efter markedsføring) og inkluderer ca. 5.000 patienter behandlet med vareniclin.
English: Patients who stopped smoking by Week 12 were then randomised to receive either CHAMPIX (1 mg twice daily) or placebo for an additional 12 weeks for a total study duration of 52 weeks.
Danish: Patienter, der var stoppet med at ryge ved uge 12, blev derefter randomiseret til at få enten CHAMPIX (1 mg 2 gange dagligt) eller placebo i yderligere 12 uger i en total studieperiode på 52 uger.
English: The meta-analysis showed that exposure to CHAMPIX resulted in a hazard ratio for MACE of 2.83 (95% confidence interval from 0.76 to 10.55, p=0.12) for patients during treatment and 1.95 (95% confidence interval from 0.79 to 4.82, p=0.15) for patients up to 30 days after treatment.
Danish: Meta-analysen viste, at der ved eksponering for CHAMPIX var en hazard ratio for MACE på 2,83 (95% konfidensinterval 0,76-10,55, p=0,12) for patienter under behandlingen og 1,95 (95% konfidensinterval 0,79-4,82, p=0,15) for patienter i op til 30 dage efter behandling.
English: UNIQUE IDENTIFIER - 2D BARCODE Not Applicable
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: Keep the package intact
Danish: Pakningen skal forblive hel
English: CHAMPIX smoking cessation studies have provided data in patients with a history of psychiatric disorders (see section 5.1).
Danish: CHAMPIX-studier af rygestop har givet data for patienter med tidligere psykisk sygdom (se pkt.
English: Stop taking CHAMPIX and tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: swelling of the face, lips, tongue, gums, throat or body and/or difficulty breathing, wheezing.
Danish: De skal stoppe med at tage CHAMPIX og straks kontakte lægen, hvis De får nogle af de disse symptomer: hævelse i ansigtet, læberne, tungen, gummerne, halsen eller kroppen og/eller vejtrækningsbesvær eller hvæsen.
English: Use with other therapies for smoking cessation
Danish: Anvendelse sammen med andre midler til rygeophør
English: OTHER sun as symbol moon as symbol
Danish: sol som symbol måne som symbol
English: If you stop taking CHAMPIX
Danish: Hvis De holder op med at tage CHAMPIX
English: Serious side effects of either an uncommon or rare frequency have occurred in people attempting to quit smoking with CHAMPIX: seizure, stroke, heart attack, suicidal thoughts, loss of contact with reality and unable to think or judge clearly (psychosis), changes in thinking or behaviour (such as aggression and abnormal behaviour).
Danish: Alvorlige bivirkninger med hyppighederne ikke almindelige eller sjældne hos personer, der har forsøgt at holde op med at ryge ved at tage CHAMPIX: kramper, slagtilfælde, hjerteanfald, selvmordstanker, tab af realitetssans og ude af stand til at tænke og vurdere klart (psykose), ændret tankegang og adfærd (f.eks. aggressiv og unormal adfærd).
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome and Erythema Multiforme) have been reported with the use of CHAMPIX.
Danish: Der er set hududslæt (Stevens-Johnsons syndrom og Erythema multiforme), som muligvis kan være livstruende ved brug af CHAMPIX.
English: Patients who cannot tolerate adverse reactions of CHAMPIX may have the dose lowered temporarily or permanently to 0.5 mg twice daily.
Danish: Hos patienter, der ikke kan tolerere bivirkningerne ved CHAMPIX, kan dosis midlertidigt eller permanent reduceres til 0,5 mg 2 gange dagligt.
English: Electrophysiology studies in vitro and neurochemical studies in vivo have shown that varenicline binds to the α4β2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a significantly lower level than nicotine.
Danish: Elektrofysiologiske undersøgelser in vitro og neurokemiske undersøgelser in vivo har vist, at vareniclin bindes til α4β2 neuronale nicotin-acetylcholin receptorer og stimulerer receptor-medieret aktivitet.
English: During the active treatment period, the incidence of suicide-related events was similar between the varenicline-treated and the placebo-treated subjects (11 vs. 9.3%, respectively).
Danish: Under aktiv behandling var incidencen af selvmordsrelaterede hændelser sammenlignelig mellem vareniclin- og placebogruppen (hhv. 11% vs. 9,3%).
English: Minor metabolites in urine include varenicline N-carbamoylglucuronide and hydroxyvarenicline.
Danish: Mindre betydningsfulde metabolitter i urinen omfatter vareniclin-Ncarbamoylglucuronid og hydroxyvareniclin.
English: Overall, a small number of MACE occurred during treatment in the trials included in the meta-analysis (CHAMPIX 7 [0.17%]; placebo 2 [0.07%]).
Danish: Samlet set blev der observeret et lille antal MACE under behandlingen i studierne fra meta-analysen (CHAMPIX 7 (0,17%); placebo 2 (0,07%)).
English: As a precautionary measure, it is preferable to avoid the use of varenicline during pregnancy (see section 5.1).
Danish: For en sikkerheds skyld bør vareniclin undgås under graviditeten (se pkt.
English: Patients experiencing these symptoms should discontinue treatment with varenicline and contact a health care provider immediately.
Danish: Patienter, der får sådanne symptomer, skal seponere behandlingen med vareniclin og straks kontakte lægen.
English: In the majority of cases nausea occurred early in the treatment period, was mild to moderate in severity and seldom resulted in discontinuation.
Danish: Kvalme forekommer i de fleste tilfælde tidligt i behandlingsforløbet, og den er mild til moderat.
English: 0.5 mg twice daily Day 8 - End of treatment: 1 mg twice daily
Danish: 0,5 mg 2 gange dagligt Dag 8-resten af behandlingen 1 mg 2 gange dagligt
English: The 4W-CQR (weeks 9 through 12) and CA rate (weeks 9 through 52) from studies 1 and 2 are included in the following table:
Danish: 4W-CQR (uge 9 til og med uge 12) og CA rater (uge 9 til og med uge 52) fra studierne 1 og 2 fremgår af nedenstående tabel:
English: No dosage adjustment is recommended based on concomitant cimetidine administration in subjects with normal renal function or in patients with mild to moderate renal impairment.
Danish: Ved samtidig administration af cimetidin anbefales dosisjustering ikke til patienter med normal nyrefunktion eller patienter med mild til moderat nedsat nyrefunktion.
English: Pooled data from these 18 trials showed a similar incidence rate of individual categories of psychiatric events in patients treated with varenicline compared to patients treated with placebo.
Danish: De poolede data fra disse 18 studier viser sammenlignelige incidensrater for de enkelte kategorier af psykiatriske bivirkninger hos de patienter, der blev behandlet med vareniclin, sammenlignet med de patienter, fik placebo.
English: Through end of study MACE, n (%)
Danish: Til og med afslutning af studiet MACE, n (%)
English: Varenicline
Danish: Vareniclin
English: Two identical double-blind clinical trials prospectively compared the efficacy of CHAMPIX (1 mg twice daily), sustained release bupropion (150 mg twice daily) and placebo in smoking cessation.
Danish: 2 identiske, dobbeltblindede kliniske studier sammenlignede virkningen af CHAMPIX (1 mg 2 gange dagligt), depotformuleret bupropion (150 mg 2 gange dagligt) og placebo ved rygeophør.
English: Scotoma, scleral discolouration, mydriasis, photophobia, myopia, lacrimation increased
Danish: Skotom, misfarvning af sclera, mydriasis, fotofobi, myopi, øget tåresekretion
English: What CHAMPIX contains - The active substance is varenicline.
Danish: CHAMPIX indeholder det aktive stof vareniclin.
English: Česká republika Pfizer PFE, spol.
Danish: Česká republika Pfizer PFE, spol s r.o.
English: The fourth study showed no evidence of a higher risk of fatal and non-fatal self- harm (HR of 0.88; 95% CI: 0.52-1.49) in patients prescribed varenicline compared to patients prescribed NRT.
Danish: Det fjerde studie viste ingen evidens for højere risiko for dødelig og ikke-dødelig selvskade (HR på 0,88; 95% CI: 0,52-1,49) hos de patienter, der fik ordineret vareniclin, sammenlignet med de patienter, der fik ordineret nicotinsubstitution.
English: Among reported neuropsychiatric adverse events, insomnia was the only event reported in either treatment group in ≥ 5% of subjects at a rate higher in the varenicline group than in placebo (9.5% vs. 4.7%).
Danish: Blandt neuropsykiatriske bivirkninger var søvnløshed den eneste rapporterede bivirkning i begge behandlingsgrupper og sås hos ≥ 5% af patienterne og med højere incidens i vareniclin-gruppen end i placebo-gruppen (9,5% vs. 4,7%).
English: * NEC = Not Elsewhere Classified Counts (percentages) corresponds to the number of patients reporting the event
Danish: Antal (procent) svarer til antallet af patienter, der har rapporteret om hændelsen
English: The third study assessed the benefit of an additional 12 weeks of CHAMPIX therapy on the maintenance of abstinence.
Danish: Det tredje studie vurderer den gavnlige virkning af yderligere 12 ugers behandling med CHAMPIX for at fastholde rygeophør.
English: In this study, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone.
Danish: I dette kliniske studie var incidencen af kvalme, hovedpine, opkastning, svimmelhed, dyspepsi og træthed større i kombinationsgruppen end hos gruppen der kun fik nicotinsubstitution.
English: In this study, infants exposed to CHAMPIX in utero as compared to infants born to mothers who smoked during pregnancy had lower rates of congenital malformations (3.6% vs 4.3%), stillbirth (0.3% vs 0.5%), preterm birth (7.5% vs 7.9%), small for gestational age (12.5% vs 17.1%), and premature rupture of membrane (3.6% vs 5.4%).
Danish: Spædbørn, som var blevet eksponeret for CHAMPIX in utero, havde, sammenlignet med spædbørn født af mødre som røg under graviditeten, i dette studie færre medfødte misdannelser (3,6 % vs. 4,3 %), dødfødsel (0,3 % vs. 0,5 %), for tidlig fødsel (7,5 % vs. 7,9 %), lille i forhold til gestationsalder (12,5 % vs. 17,1 %) og præterm primær vandafgang (3,6 % vs. 5,4 %).
English: 12-week Treatment Initiation Pack
Danish: 12-ugers startpakning
English: Deaths and cardiovascular events were adjudicated by a blinded, independent committee.
Danish: Dødsfald og kardiovaskulære bivirkninger blev vurderet af en blindet uafhængig komite.
English: Odds ratio CHAMPIX vs. bupropion p < 0.0001
Danish: Oddsratio CHAMPIX vs. bupropion p < 0,0001
English: CHAMPIX was evaluated in a double-blind, placebo-controlled trial of 494 patients who had made a previous attempt to quit smoking with CHAMPIX, and either did not succeed in quitting or relapsed after treatment.
Danish: Studie med forsøgspersoner, der genbehandles med CHAMPIX CHAMPIX blev evalueret i et dobbelt-blindet, placebokontrolleret studie med 494 patienter, der tidligere havde forsøgt at stoppe med at ryge med CHAMPIX, og som enten ikke var holdt op med at ryge, eller som var begyndt at ryge igen efter behandlingens afslutning.
English: Therefore, varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Danish: Det er derfor usandsynligt, at vareniclin ændrer farmakokinetikken af stoffer, der primært metaboliseres af CYP450-enzymer.
English: Patients received treatment for 12 weeks, followed by a non-treatment period of 40 weeks, along with age-appropriate counseling throughout the study.
Danish: Patienterne fik behandling i 12 uger efterfulgt af en 40-ugers periode uden behandling og alderssvarende rådgivning igennem hele studiet.
English: There have also been reports of severe skin reactions including Erythema Multiforme (a type of rash) and Stevens-Johnson Syndrome (a serious illness with blistering of the skin, mouth, around the eyes or genitals) and serious allergic reactions including angioedema (swelling of the face, mouth, or throat).
Danish: Der er også set tilfælde af alvorlige hudreaktioner, herunder erythema multiforme (en type udslæt) og Stevens-Johnsons syndrom (en alvorlig lidelse, der viser sig ved blæredannelse på huden omkring munden og øjnene eller kønsorganerne) og alvorlige overfølsomhedsreaktioner, herunder angioødem (hævelser i ansigt, mund eller hals).
English: Day 1 - 3
Danish: Dag 1-3
English: Bottles: 2 years
Danish: Beholder: 2 år.
English: Varenicline pharmacokinetics were unchanged in subjects with mild renal impairment (estimated creatinine clearance > 50 ml/min and  80 ml/min).
Danish: Vareniclins farmakokinetik er uændret hos patienter med mildt nedsat nyrefunktion (anslået kreatininclearance >50 ml/min og 80 ml/min).
English: The following adjudicated events occurred with a frequency ≥ 1% in either treatment group during treatment (or in the 30-day period after treatment): nonfatal myocardial infarction (1.1% vs. 0.3% for CHAMPIX and placebo, respectively), and hospitalisation for angina pectoris (0.6% vs. 1.1%).
Danish: Følgende hændelser, der blev betragtet som værende relateret til behandlingen, blev set med en frekvens ≥ 1% i begge grupper under behandlingen (eller inden for 30 dage efter behandlingen): non-letal myokardieinfarkt (hhv. 1,1% vs. 0,3% for CHAMPIX og placebo) og hospitalsindlæggelse for angina pectoris (0,6% vs. 1,1%).
English: CHAMPIX dosing should usually start 1-2 weeks before this date (see section 5.1).
Danish: CHAMPIX-behandlingen bør sædvanligvis begynde 12 uger før denne dato (se pkt.
English: Four observational studies, each including 10,000 to 30,000 users of varenicline in the adjusted analyses, compared the risk of serious neuropsychiatric events, including neuropsychiatric hospitalizations and fatal and non-fatal self-harm, in patients treated with varenicline versus patients prescribed NRT or bupropion.
Danish: Fire observationsstudier, der hver omfattede 10.000 til 30.000 vareniclinbrugere i de justerede analyser, sammenlignede risikoen for alvorlige neurospykiatriske hændelser, herunder neurospykiatriske indlæggelser samt dødelig og ikke-dødelig selvskade hos de patienter, der blev behandlet med vareniclin, sammenlignet med de patienter, der fik ordineret nicotinsubstitution eller bupropion.
English: Adverse Drug Reactions Infections and infestations Very common Nasopharyngitis Common
Danish: Systemorganklasser Bivirkninger Infektioner og parasitære sygdomme Meget almindelig Nasopharyngitis Almindelig
English: Patients should then continue taking CHAMPIX for an additional 12 weeks for a total of 24 weeks of treatment (see section 5.1).
Danish: Derefter skal patienterne fortsætte med at tage CHAMPIX i yderligere 12 uger til i alt 24 ugers behandling (se pkt.
English: In a smoking cessation clinical trial, neuropsychiatric adverse events were reported more frequently in patients with a history of psychiatric disorders compared to those without a history of psychiatric disorders, regardless of treatment (see section 5.1).
Danish: I et klinisk rygestopforsøg blev der hyppigere rapporteret neuropsykiatriske bivirkninger hos patienter med tidligere psykisk forstyrrelse sammenlignet med patienter uden tidligere psykisk forstyrrelse, uanset behandling (se pkt.
English: A large randomised, double-blind, active and placebo-controlled study was conducted to compare the risk of serious neuropsychiatric events in patients with and without a history of psychiatric disorder treated for smoking cessation with varenicline, bupropion, nicotine replacement therapy patch (NRT) or placebo.
Danish: Et stort, randomiseret, dobbeltblindet, aktivt og placebokontrolleret studie blev udført for at sammenligne risikoen for alvorlige neuropsykiatriske hændelser hos patienter med og uden tidligere psykisk sygdom, der blev behandlet med vareniclin, bupropion, nikotinplastre eller placebo med henblik på rygestop.
English: Day 4 - 7
Danish: Dag 4-7
English: Adverse drug reactions are based on evaluation of data from pre-marketing phase 2-3 studies and updated based on pooled data from
Danish: Bivirkningerne anført i tabellen nedenfor er baseret på evaluering af data fra fase 2-3 studier (udført før markedsføring) og opdateret i.h.t.
English: Overall n/N (%)
Danish: Samlet n/N (%)
English: Hypromellose Titanium Dioxide (E171) Macrogol 400
Danish: Hypromellose Titandioxid (E171) Macrogol 400
English: Subjects with mild-moderate chronic obstructive pulmonary disease (COPD) The efficacy and safety of CHAMPIX (1 mg twice daily) for smoking cessation in subjects with mild-moderate COPD was demonstrated in a randomised double-blind placebo-controlled clinical trial.
Danish: Patienter med mild til moderat kronisk obstruktiv lungesygdom (KOL) Effekt og sikkerhed af CHAMPIX (1 mg 2 gange dagligt) til rygeophør hos patienter med mild til moderat KOL blev vist i et randomiseret dobbelt-blindet placebokontrolleret klinisk studie.
English: Two thousand six hundred nineteen (2619) patients received CHAMPIX 1 mg BID (titrated during the first week), 669 patients received bupropion 150 mg BID (also titrated) and 684 patients received placebo.
Danish: 2.619 patienter fik CHAMPIX 1 mg 2 gange dagligt (dosistitreret i løbet af den første uges behandling), 669 patienter fik bupropion 150 mg 2 gange dagligt (ligeledes dosistitreret) og 684 patienter fik placebo.
English: The primary study endpoint was the CO-confirmed continuous abstinence rate from week 13 through week 24 in the double-blind treatment phase.
Danish: Det primære endepunkt var en CO-bekræftet afholdenhedsrate (CA) fra uge 13 til og med uge 24 i den dobbelt-blindede behandlingsperiode.
English: In rodents, varenicline is transferred through the placenta and excreted in milk.
Danish: Hos gnavere krydser vareniclin placenta og udskilles i modermælken.
English: There have been post-marketing reports of hypersensitivity reactions including angioedema in patients treated with varenicline.
Danish: Efter markedsføring er der set overfølsomhedsreaktioner herunder angioødem hos patienter i behandling med vareniclin.
English: If you are not willing or able to set a target quit date within 2 weeks, you may choose your own target quit date within 5 weeks after starting treatment.
Danish: Hvis De ikke ønsker eller ikke kan sætte en dato for rygestop inden for de første 2 uger, kan De vælge en dato inden for de første 5 uger af behandlingen.
English: Two of the studies found no difference in risk of neuropsychiatric hospitalisations between varenicline users and nicotine patch users (Hazard Ratio [HR] 1.14; 95% Confidence Interval [CI]: 0.56-2.34 in the first study, and 0.76; 95% CI: 0.40-1.46 in the second study).
Danish: To af studierne fandt ikke nogen forskel i risikoen for neuropsykiatriske indlæggelser hos vareniclinbrugerne sammenlignet med dem, der brugte nikotinplastre (hazard ratio [HR] 1,14; 95% konfidensinterval [CI]: 0,56-2,34 i det første studie og 0,76; 95% CI: 0,40-1,46 i det andet studie).
English: Minor circulating metabolites include varenicline N-carbamoylglucuronide and N-glucosylvarenicline.
Danish: Mindre betydningsfulde metabolitter i kredsløbet omfatter vareniclinN-carbamoylglucuronid og N-glucosylvareniclin.
English: The effect of varenicline on craving, withdrawal and reinforcing effects of smoking were not measured during the non-treatment long-term follow-up phase.
Danish: Vareniclins virkning på trangen til at ryge, på rygeophøret og på den forstærkede virkning af rygning blev ikke målt i perioden uden behandling.
English: In addition, the table shows the subset of the composite NPS AE endpoint of severe intensity:
Danish: Derudover viser tabellen det sammensatte endepunkt for NPS AE af svær grad:
English: Your doctor may decide to gradually lower your dose of CHAMPIX at the end of treatment.
Danish: Lægen kan derfor gradvist trappe behandling ned hen mod slutningen af behandlingen.
English: Atrial fibrillation, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased
Danish: Atrieflimren, ST-segment-depression og formindsket T-bølgeamplitude i ekg
English: Glycosuria, polyuria
Danish: Glykosuri, polyuri
English: Film-coated tablet of 4 mm x 8 mm
Danish: Filmovertrukken tablet på 4 mm x 8 mm
English: Blisters: Store below 30°C
Danish: Blister: Må ikke opbevares ved temperaturer over 30 °C.
English: Other medicines and CHAMPIX
Danish: Brug af anden medicin sammen med CHAMPIX
English: These could include changes of mood (like feeling depressed, irritable, frustrated or anxious), sleeplessness, difficulty concentrating, decreased heart rate and increased appetite or weight gain.
Danish: Symptomerne omfatter humørændringer (De kan føle Dem nedtrykt, irritabel, frustreret eller ængstelig), søvnighed, koncentrationsbesvær, nedsat hjerterytme og øget appetit eller vægtøgning.
English: No dosage adjustment is necessary for patients with mild (estimated creatinine clearance > 50 ml/min and  80 ml/min) to moderate (estimated creatinine clearance  30 ml/min and  50 ml/min) renal impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let (anslået kreatininclearance >50 ml/min og 80 ml/min) til moderat (anslået kreatininclearance ≥30 ml/min og 50 ml/min) nedsat nyrefunktion.
English: For patients with moderate renal impairment who experience adverse reactions that are not tolerable, dosing may be reduced to 1 mg once daily.
Danish: Hos patienter med moderat nedsat nyrefunktion, der oplever generende bivirkninger, bør dosis nedsættes til 1 mg 1 gang dagligt.
English: There are no clinically meaningful differences in varenicline pharmacokinetics due to age, race, gender, smoking status, or use of concomitant medicinal products, as demonstrated in specific pharmacokinetic studies and in population pharmacokinetic analyses.
Danish: Der er ingen forskelle af klinisk betydning i vareniclins farmakokinetik med hensyn til alder, race, køn, rygerstatus eller samtidig brug af anden medicin.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er de alvorligste bivirkninger anført først.
English: Therefore, varenicline can effectively block nicotine's ability to fully activate α4β2 receptors and the mesolimbic dopamine system, the neuronal mechanism underlying reinforcement and reward experienced upon smoking.
Danish: Vareniclin kan derfor effektivt blokere nicotins evne til fuldt ud at aktivere α4β2 receptorer og det mesolimbiske dopaminsystem.
English: Film-coated tablet of 5 mm x 10 mm
Danish: Filmovertrukken tablet på 5 mm x 10 mm
English: The primary CV endpoint was the time to major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke during treatment.
Danish: Det primære endepunkt for kardiovaskulær risiko var tid til alvorlig kardiovaskulær hændelse (MACE), defineret som kardiovaskulær død, ikke-dødeligt myokardieinfarkt og ikke-dødelig fatal apopleksi under behandlingen.
English: Subjects aged 18-75 years, smoking 10 or more cigarettes per day were randomised 1:1:1:1 to varenicline 1 mg BID, bupropion SR 150 mg BID, nicotine replacement therapy patch (NRT) 21 mg/day with taper or placebo for a treatment period of 12 weeks; they were then followed for another 12 weeks post-treatment.
Danish: Forsøgspersoner i alderen 18-75 år, der røg mindst 10 cigaretter om dagen, blev randomiseret 1:1:1:1 til vareniclin 1 mg to gange dagligt, bupropion SR 150 mg to gange dagligt, nikotinplaster 21 mg/dag med nedtrapning eller placebo i en behandlingsperiode på 12 uger.
English: What you need to know before you take CHAMPIX
Danish: Det skal De vide, før De begynder at tage CHAMPIX
English: Numbers 1 to 14 sun as symbol moon as symbol
Danish: Nummereret 1 - 14 sol som symbol måne som symbol