FrancophonIA/ELRC3.0 huggingface dataset:
English: CHAMPIX was evaluated in a randomised, double-blind, placebo-controlled study of subjects with stable, cardiovascular disease (other than, or in addition to, hypertension) that had been diagnosed for more than 2 months.
Danish: CHAMPIX blev evalueret i et randomiseret, dobbelt-blindet placebokontrolleret studie med patienter, der var diagnosticeret med stabil kardiovaskulær sygdom (anden end eller udover hypertension) for mere end 2 måneder siden.
English: The prescriber should inform the patient accordingly and discuss or consider the need for dose tapering.
Danish: Lægen bør informere patienten om dette og overveje, om det er nødvendigt at nedtrappe behandlingen.
English: These trials included the 5 trials described above that used the C-SSRS, and a total of 8521 patients (5072 varenicline, 3449 placebo), some of which had psychiatric conditions.
Danish: Disse studier inkluderede de 5 studier, der er beskrevet ovenfor, som brugte C-SSRS-skalaen, og omfattede i alt 8.521 patienter (5.072 vareniclin og 3.449 placebo), hvoraf nogle havde psykiatriske lidelser.
English: Varenicline is highly selective and binds more potently to the α4β2 receptor subtype (Ki=0.15 nM) than to other common nicotinic receptors (α3β4 Ki=84 nM, α7 Ki= 620 nM, α1βγδ Ki= 3,400 nM), or to non-nicotinic receptors and transporters (Ki > 1µM, except to 5-HT3 receptors: Ki=350 nM).
Danish: Vareniclin er meget selektivt og bindes mere til α4β2-receptorundertyper (Ki=0,15-nM) end til nogen andre af de almindelige nicotinreceptorer (α3β4 Ki=84 nM, α7 Ki=620 nM, α1βγδ Ki=3.400 nM) eller til ikke-nicotinreceptorer og transportsystemer (Ki>1 μM, på nær 5-HT3 receptorer: Ki=350 nM).
English: At the end of treatment, discontinuation of CHAMPIX was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients.
Danish: Efter endt behandling medførte seponering af CHAMPIX, at op til 3% af patienterne oplevede øget irritabilitet, rygetrang, depression og/eller søvnløshed.
English: Maximum plasma concentrations of varenicline occur typically within 3-4 hours after oral administration.
Danish: Efter oral administration af vareniclin opnås der typisk maksimal plasmakoncentration efter 3-4 timer.
English: Bottle: This medicine does not require any special storage conditions.
Danish: HDPE beholder: Dette lægemiddel kræver ingen særlige forholdsregler vedr.
English: Prothrombin time (INR) was not affected by varenicline.
Danish: Protrombintid (INR) påvirkes ikke af vareniclin.
English: Very common Abnormal dreams, insomnia Uncommon
Danish: Meget almindelig Drømmeforstyrrelser, søvnløshed Ikke almindelig
English: Paranoiab
Danish: Paranoia
English: The use of CHAMPIX, bupropion, and NRT was not associated with an increased risk of CV AEs in smokers treated for up to 12 weeks and followed for up to 1 year compared to placebo, although because of the relatively low number of events overall, an association cannot be entirely ruled out.
Danish: Anvendelsen af CHAMPIX, bupropion og nikotinplaster var ikke forbundet med en øget risiko for kardiovaskulære bivirkninger hos rygere behandlet i op til 12 uger og fulgt i op til 1 år sammenlignet med placebo, selvom det, på grund af det forholdsvis lave antal samlede bivirkninger, ikke kan udelukkes helt.
English: Ísland Icepharma hf.
Danish: Icepharma hf.
English: Additionally, a small number of MACE occurred up to 30 days after treatment (CHAMPIX 13 [0.31%]; placebo 6 [0.21%]).
Danish: Derudover blev der set et lille antal MACE op til 30 dage efter behandling (CHAMPIX 13 (0,31%); placebo 6 (0,21%)).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, fertility and embryo-foetal development.
Danish: De prækliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet og toksicitet i forbindelse med reproduktion.
English: Patients who are motivated to quit and who did not succeed in stopping smoking during prior CHAMPIX therapy, or who relapsed after treatment, may benefit from another quit attempt with CHAMPIX (see section 5.1).
Danish: Patienter, der er motiveret for at stoppe med at ryge, og som det ikke er lykkedes at stoppe under tidligere CHAMPIX-behandling, eller som er begyndt at ryge igen efter behandlingens afslutning, kan have gavn af et nyt forsøg på rygestop med CHAMPIX (se pkt.
English: In male rats dosed for 2 years with varenicline, there was a dose-related increase in the incidence of hibernoma (tumour of the brown fat).
Danish: Hos hanrotter, der får vareniclin i 2 år, ses der en dosisrelateret øget incidens af hibernoma (tumor i det brune fedtvæv).
English: These effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Disse virkninger ses kun ved niveauer, der overgik maksimal human eksponering og det har derfor kun lille betydning i klinikken.
English: If you accidentally take more CHAMPIX than your doctor prescribed, you must seek medical advice or go to the nearest hospital casualty department immediately.
Danish: Hvis De ved et uheld har taget mere CHAMPIX, end Deres læge har ordineret, skal De omgående kontakte lægen eller den nærmeste skadestue.
English: Diabetes mellitus, polydipsia Psychiatric disorders
Danish: Diabetes mellitus, polydipsi
English: If serious neuropsychiatric symptoms occur whilst on varenicline treatment, patients should discontinue varenicline immediately and contact a healthcare professional for re-evaluation of treatment.
Danish: Hvis der forekommer alvorlige neuropsykiatriske symptomer under behandlingen med vareniclin, skal patienterne omgående seponere vareniclin og kontakte en læge med henblik på revurdering af behandlingen.
English: The most commonly reported adverse events in subjects treated with varenicline in this study were similar to those observed in premarketing studies.
Danish: De hyppigst rapporterede bivirkninger hos forsøgspersoner behandlet med vareniclin i dette studie svarede til dem, der sås i studier inden markedsføring.
English: There have been some reports of increased intoxicating effects of alcohol in patients taking CHAMPIX.
Danish: Der er set øget alkoholforgiftnende virkninger hos patienter som tager CHAMPIX.
English: 28 Film-coated tablets 56 Film-coated tablets 112 Film-coated tablets 140 Film-coated tablets
Danish: 28 filmovertrukne tabletter 56 filmovertrukne tabletter 112 filmovertrukne tabletter 140 filmovertrukne tabletter
English: Somnolence, dizziness, dysgeusia
Danish: Søvnighed, svimmelhed, dysgeusi
English: Furthermore since metabolism of varenicline represents less than 10% of its clearance, active substances known to affect the cytochrome P450 system are unlikely to alter the pharmacokinetics of varenicline (see section 5.2) and therefore a dose adjustment of CHAMPIX would not be required.
Danish: Da metabolismen af vareniclin endvidere udgør mindre end 10% af dets clearance, er det usandsynligt, at aktive stoffer, der påvirker CYP450-systemet, vil ændre farmakokinetikken af vareniclin (se pkt.
English: After the initial 12-week reduction phase, subjects continued treatment for another 12 weeks.
Danish: Efter den indledende reduktionsfase på 12 uger fortsatte forsøgspersonerne behandlingen i yderligere 12 uger.
English: Contains No Blue Box
Danish: Uden blå boks
English: There are no clinical data on the effects of varenicline on fertility.
Danish: Der foreligger ikke kliniske data om vareniclins påvirkning af fertiliteten.
English: Maintenance pack
Danish: Vedligeholdelsespakning
English: It is unknown whether varenicline is excreted in human breast milk.
Danish: Det vides ikke om vareniclin udskilles i modermælken hos mennesker.
English: A meta-analysis of 15 clinical trials of ≥ 12 weeks treatment duration, including 7002 patients (4190 CHAMPIX, 2812 placebo), was conducted to systematically assess the cardiovascular safety of CHAMPIX.
Danish: En meta-analyse af 15 kliniske studier med ≥12 ugers behandling af 7.002 patienter (4.190 fik CHAMPIX og 2.812 fik placebo) blev udført for systematisk at vurdere CHAMPIX' kardiovaskulære sikkerhed.
English: Subjects with cardiovascular disease
Danish: Patienter med kardiovaskulær sygdom
English: If you are taking CHAMPIX and develop agitation, depressed mood, changes in behaviour that are of concern to you or your family or if you develop suicidal thoughts or behaviours you should stop taking CHAMPIX and contact your doctor immediately for treatment assessment.
Danish: Hvis De tager CHAMPIX og De oplever ophidselse, nedtrykthed eller ændringer i Deres adfærd, som bekymrer Dem eller Deres familie, eller hvis De får selvmordstanker eller selvmordsadfærd, skal De holde op med at tage CHAMPIX og straks kontakte Deres læge for at få vurderet behandlingen.
English: The patient should set a date to stop smoking.
Danish: Patienten bør fastsætte en dato for rygestop.
English: Odds ratio in CAR 9-12 (95% CI) [p-value]
Danish: Odds ratio i CAR 9-12 (95 % CI) [p-værdi]
English: Do not use this medicine after the expiry date which is stated on the card packaging or carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Get emergency medical help right away if you have symptoms of a heart attack or stroke.
Danish: Ring straks 112, hvis De oplever symptomer på et hjerteanfald eller slagtilfælde.
English: In patients treated with the recommended dose of 1 mg twice daily following an initial titration period the adverse event most commonly reported was nausea (28.6%).
Danish: Hos patienter, der blev behandlet med den anbefalede dosis på 1 mg 2 gange dagligt efter en initial titreringsperiode er den hyppigste bivirkning kvalme (28,6%).
English: After 12 weeks of treatment, if you have stopped smoking, your doctor may recommend an additional 12 weeks of treatment with CHAMPIX 1 mg film-coated tablets twice daily to help avoid returning back to smoking.
Danish: Hvis De er holdt op med at ryge efter 12 ugers behandling, kan Deres læge anbefale yderligere 12 ugers behandling med CHAMPIX 1 mg filmovertrukne tabletter 2 gange dagligt som hjælp til at undgå at begynde at ryge igen.
English: Patients taking CHAMPIX should be instructed to notify their doctor of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke (see section 5.1).
Danish: Patienter, der tager CHAMPIX, skal informeres om at kontakte lægen, hvis der opstår nye kardiovaskulære symptomer, eller hvis eksisterende kardiovaskulære symptomer forværres, og omgående søge læge eller skadestue, hvis de oplever tegn og symptomer på myokardieinfarkt eller apopleksi (se pkt.
English: You should then continue to take CHAMPIX 1 mg film-coated tablets twice daily for a further 12 weeks resulting in a total of 24 weeks of treatment.
Danish: Derefter skal De fortsætte med at tage CHAMPIX 1 mg filmovertrukne tabletter 2 gange dagligt i yderligere 12 uger til i alt 24 ugers behandling.
English: A meta-analysis of 5 randomised, double-blind, placebo controlled trials, including 1907 patients (1130 varenicline, 777 placebo), was conducted to assess suicidal ideation and behaviour as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS).
Danish: En meta-analyse af 5 randomiserede, dobbelt-blinde, placebokontrollerede studier, der omfattede 1.907 patienter (1.130 vareniclin og 777 placebo), blev udført for at vurdere selvmordstanker og -adfærd rapporteret efter Columbia-Suicide Severity Rating Scale (C-SSRS).
English: If you develop a rash or if your skin starts to peel or blister you should stop taking CHAMPIX and seek emergency medical help.
Danish: Hvis De får udslæt eller hvis Deres hud begynder at skalle af eller De får blærer, skal De stoppe med at tage CHAMPIX og straks søge lægehjælp.
English: Patients treated with CHAMPIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 and from weeks 9 through 52 compared to subjects treated with placebo.
Danish: Patienter, der blev behandlet med CHAMPIX, havde en højere forekomst af CO-bekræftet afholdenhed i uge 9-12 og fra uge 9 til uge 52 sammenlignet med forsøgspersoner i placebogruppen.
English: There have also been post-marketing reports of rare but severe cutaneous reactions, including StevensJohnson Syndrome and Erythema Multiforme in patients using varenicline.
Danish: Efter markedsføring er der også set sjældne, men alvorlige tilfælde af hudreaktioner, herunder Stevens-Johnsons syndrom og erythema multiforme hos patienter i behandling med vareniclin.
English: Your doctor and pharmacist can provide advice, support and sources of further information to help ensure your attempt to stop smoking is successful.
Danish: Det er mere sandsynligt, at De kan holde op med at ryge, hvis De er motiveret til at holde op. Deres læge og apotek kan yde rådgivning, støtte og give mere information for at sikre, at Deres forsøg på at holde op med at ryge bliver succesfuldt.
English: Oral bioavailability of varenicline is unaffected by food or time-of-day dosing.
Danish: Vareniclins orale biotilgængelighed af vareniclin bliver hverken påvirket af fødeindtag eller tidspunkt for dosering.
English: The treatment discontinuation rate due to adverse reactions was 11.4% for varenicline compared with 9.7% for placebo.
Danish: Seponeringsraten på grund af bivirkninger er 11,4% for vareniclin sammenlignet med 9,7% for placebo.
English: No attempt has been made in either the design or the analysis of the CHAMPIX studies to distinguish between adverse reactions associated with study drug treatment or those possibly associated with nicotine withdrawal.
Danish: Der er i CHAMPIX-undersøgelserne ikke anvendt design eller analyser for at skelne mellem bivirkninger, der var forbundet med den anvendte studiemedicin og bivirkninger, der var forbundet med nicotinophør.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with CHAMPIX should be made taking into account the benefit of breast-feeding to the child and the benefit of CHAMPIX therapy to the woman.
Danish: Det skal besluttes, om amning eller behandling med CHAMPIX skal fortsætte/ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske for moderen.
English: Smoking cessation itself may result in changes to warfarin pharmacokinetics (see section 4.4).
Danish: Rygeophør kan i sig selv medføre ændringer i farmakokinetikken af warfarin (se pkt.
English: Pharmacotherapeutic group: Other nervous system drugs; Drugs used in addictive disorders; Drugs used in nicotine dependence, ATC code: N07BA03
Danish: Farmakoterapeutisk klassifikation: Andre midler mod lidelser i nervesystemet: midler mod afhængighedsforstyrrelser: midler mod nicotinafhængighed, ATC-kode: N07BA03
English: The recommended dose is 1 mg varenicline twice daily following a 1-week titration as follows: Days 1 - 3:
Danish: Den anbefalede dosis er 1 mg vareniclin 2 gange dagligt efter 1 uges dosistitrering på følgende måde:
English: • Obligation to conduct post-authorisation measures Not Applicable.
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
English: 0.5 mg once daily
Danish: 0,5 mg 1 gang dagligt
English: If you forget to take CHAMPIX
Danish: Hvis De har glemt at tage CHAMPIX
English: There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking CHAMPIX.
Danish: Der er set tilfælde af depression, selvmordstanker, selvmordsadfærd og selvmordsforsøg hos patienter, som tager CHAMPIX.
English: In the varenicline group compared to placebo, a higher proportion of subjects reported suicidal ideation or behaviour prior to enrolment (lifetime history) and after the end of active treatment period (on Days 33 to 85 after the last dose of treatment).
Danish: Der var flere patienter i vareniclin-gruppen end i placebo-gruppen, der rapporterede om selvmordstanker eller -adfærd før inklusion (anamnese) og efter endt aktiv behandling (på dag 33 til 85 efter sidste behandlingsdosis).
English: CHAMPIX may be linked with dizziness, sleepiness and transient loss of consciousness.
Danish: CHAMPIX kan være forbundet med svimmelhed, søvnighed og forbigående bevidsthedstab.
English: In the table below all adverse reactions, which occurred at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000)).
Danish: Bivirkningerne er anført efter systemorganklasser og hyppighed (meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100) og sjælden (≥1/10.000 til <1/1.000)).
English: Should you experience adverse effects that you cannot tolerate your doctor may decide to reduce your dose temporarily or permanently to 0.5 mg twice daily.
Danish: Hvis De oplever bivirkninger, som er for generende, kan Deres læge nedsætte Deres dosis midlertidigt eller permanent til 0,5 mg 2 gange dagligt.
English: Psychiatric Cohort N=4074
Danish: Psykiatrisk kohorte N=4074
English: Patient reported craving, withdrawal and reinforcing effects of smoking Across both Studies 1 and 2 during active treatment, craving and withdrawal were significantly reduced in patients randomised to CHAMPIX in comparison with placebo.
Danish: Patienter, der rapporterer om rygetrang, rygeophør og forstærkende virkning af rygning I den aktive behandlingsperiode i både studie 1 og 2 var rygetrang og rygeophør signifikant nedsat hos patienter randomiseret til CHAMPIX sammenlignet med placebo.
English: Because elderly patients are more likely to have decreased renal function, prescribers should consider the renal status of an elderly patient.
Danish: Da ældre patienter oftere har nedsat nyrefunktion, bør der hos disse patienter tages særligt hensyn til nyrestatus.
English: No dosage adjustment is necessary for elderly patients (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: The pharmacokinetics of varenicline in elderly patients with normal renal function (aged 65-75 years) is similar to that of younger adult subjects (see section 4.2).
Danish: Vareniclins farmakokinetik hos ældre patienter med normal nyrefunktion (i alderen 65-75 år) svarer til den for yngre voksne patienter (se pkt.
English: There is currently limited clinical experience with the use of CHAMPIX among black people to determine clinical efficacy.
Danish: På nuværende tidspunkt er den kliniske erfaring med anvendelse af CHAMPIX til sorte ikke tilstrækkelig til, at klinisk effekt kan afgøres.
English: Semen analysis abnormal, C-reactive protein increased, blood calcium decreased * Frequencies are estimated from a post-marketing, observational cohort study
Danish: Abnorm sædtest, forhøjet C-reaktivt protein, nedsat calcium i blodet * frekvenserne er estimeret ud fra et observationelt kohortestudie efter markedsføring.
English: Although there were no completed suicides, there was one suicidal attempt in a varenicline-treated subject whose lifetime history included several similar attempts.
Danish: Selvom der ikke var fuldbyrdede selvmord, var der et selvmordsforsøg hos en patient i vareniclin-gruppen; denne patient havde flere lignende selvmordsforsøg i anamnesen.
English: In addition, independent observational studies have not supported an increased risk of serious neuropsychiatric events in patients treated with varenicline compared to patients prescribed nicotine replacement therapy (NRT) or bupropion.
Danish: Desuden har uafhængige observationsstudier ikke understøttet en øget risiko for svære neuropsykiatriske hændelser hos patienter, der behandles med vareniclin, sammenlignet med patienter, der får ordineret nicotinsubstitution eller bupropion.
English: Days 4 - 7:
Danish: Dag 4-7:
English: Take your box of tablets with you.
Danish: De bør tage medicinpakningen med.
English: Myocardial infarction, angina pectoris, tachycardia, palpitations, heart rate increased
Danish: Myokardieinfarkt, angina pectoris, takykardi, palpitationer, øget hjertefrekvens
English: Number of Patients and Risk Ratio for Suicidal Ideation and/or Behaviour Reported on C-SSRS from a Meta-Analysis of 5 Clinical Trials Comparing Varenicline to Placebo: Varenicline (N=1130)
Danish: Antal patienter og risikoratio for selvmordstanker og/eller -adfærd rapporteret efter C-SSRS fra en meta-analyse af 5 kliniske studier, der sammenlignede vareniclin med placebo: Vareniclin (n=1.130)
English: Following two-week titration, patients randomised to varenicline with a body weight >55 kg received 1 mg twice daily (high dose group) or 0.5 mg twice daily (low dose group), while patients with a body weight ≤55 kg received 0.5 mg twice daily (high dose group) or 0.5 mg once daily (low dose group).
Danish: Efter 2 ugers titrering fik de patienter, der var randomiseret til vareniclin, og som havde en legemsvægt > 55 kg, 1 mg to gange dagligt (højdosisgruppe) eller 0,5 mg to gange dagligt (lavdosisgruppe), mens de patienter, der havde en legemsvægt ≤ 55 kg, fik 0,5 mg to gange dagligt (højdosisgruppe) eller 0,5 mg én gang dagligt (lavdosisgruppe).
English: The efficacy and safety of varenicline was evaluated in a randomised, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years, who smoked an average of at least 5 cigarettes per day during the 30 days prior to recruitment, and had a score of at least 4 on the Fagerstrom Test for Nicotine Dependence scale.
Danish: Vareniclins virkning og sikkerhed er blevet evalueret i et randomiseret, dobbeltblindet, placebokontrolleret studie med 312 patienter i alderen 12 til 19 år, som røg i gennemsnit mindst 5 cigaretter om dagen i de 30 dage op til rekrutteringen, og som havde en score på mindst 4 på skalaen Fagerström Testen for nikotinafhængighed.
English: The primary safety endpoint was a composite of the following neuropsychiatric (NPS) adverse events: severe events of anxiety, depression, feeling abnormal, or hostility, and/or moderate or severe events of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behaviour or completed suicide.
Danish: Det primære sikkerhedsendepunkt var en sammensætning af følgende neuropsykiatriske (NPS) bivirkninger: alvorlige angsttilfælde, depression, følen sig unormal, eller fjendtlighed, og/eller moderate eller svære tilfælde af agitation, aggression, vrangforestillinger, hallucinationer, mordtanker, mani, panik, paranoia, psykose, suicidaltanker, suicidaladfærd eller gennemført selvmord.
English: Non-psychiatric Cohort N=3984
Danish: Ikke-psykiatrisk kohorte N=3984
English: Animal studies suggest that varenicline is excreted in breast milk.
Danish: Dyreforsøg har vist tegn på, at vareniclin udskilles i modermælken.
English: Use of CHAMPIX with other therapies for smoking cessation Consult your doctor before using CHAMPIX in combination with other smoking cessation therapies.
Danish: Brug af CHAMPIX sammen med anden behandling til rygeophør Kontakt lægen eller apoteket inden De begynder at bruge CHAMPIX sammen med anden medicin, som også er beregnet til rygeophør.
English: The results showed no increase in the incidence of suicidal ideation and/or behaviour in patients treated with varenicline compared to patients treated with placebo, as shown in the table below.
Danish: Resultaterne viste ingen øget forekomst af selvmordstanker og/eller -adfærd hos de patienter, der blev behandlet med vareniclin, sammenlignet med patienter, der fik placebo, som vist i tabellen herunder.
English: These events included in the endpoint were adjudicated by a blinded, independent committee.
Danish: Disse hændelser blev vurderet af en blindet uafhængig komite.
English: Nonclinical data indicate varenicline has reinforcing properties albeit with lower potency than nicotine.
Danish: Ikke-kliniske data peger på, at vareniclin har afhængighedsskabende egenskaber, om end i lavere grad end nicotin.