FrancophonIA/ELRC3.0 huggingface dataset:
English: Study in Subjects with and without a History of Psychiatric Disorder: Varenicline was evaluated in a randomised, double-blind, active and placebo-controlled study that included subjects with a history of psychiatric disorder (psychiatric cohort, N=4074) and subjects without a history of psychiatric disorder (non-psychiatric cohort, N=3984).
Danish: Neuropsykiatrisk sikkerhedsstudie af forsøgspersoner med og uden tidligere psykisk forstyrrelse Vareniclin blev evalueret i et randomiseret, dobbeltblindet, aktivt og placebokontrolleret studie, der inkluderede forsøgspersoner med tidligere psykisk forstyrrelse (psykiatrisk kohorte, N=4074) og forsøgspersoner uden tidligere psykisk forstyrrelse (ikke-psykiatrisk kohorte, N=3984).
English: In the psychiatric cohort, the percentage of subjects with suicidal ideation and/or behaviour based on the Columbia-Suicide Severity Rating Scale (C-SSRS) was similar between the varenicline and placebo groups during treatment and in the non- treatment follow-up, as shown in the following table:
Danish: I den psykiatriske kohorte var procentdelen af forsøgspersoner med suicidaltanker og/eller -adfærd baseret på Columbia-Suicide Severity Rating Scale (C-SSRS) den samme for vareniclin- og placebogrupperne under behandlingen og under opfølgningen uden behandling som vist i følgende tabel:
English: Effect of smoking cessation
Danish: Virkninger ved rygeophør
English: The percentage of subjects with suicidal ideation and/or behaviour based on the Columbia-Suicide Severity Rating Scale (C-SSRS) was similar between the varenicline and placebo groups during treatment and in the non- treatment follow-up, as shown in the following table:
Danish: Procentdelen af forsøgspersoner med suicidaltanker og/eller -adfærd baseret på Columbia-Suicide Severity Rating Scale (C-SSRS) var den samme for vareniclin- og placebogrupperne under behandlingen og under opfølgningen uden behandling som vist i følgende tabel:
English: Treatment Comparisons: Odds ratio (95% CI), p value Varenicline vs Placebo
Danish: Sammenligning af behandlinger: Oddsratio (95 % CI), p-værdi Vareniclin vs placebo
English: There were similar rates of all-cause mortality (CHAMPIX 6 [0.14%]; placebo 7 [0.25%]) and cardiovascular mortality (CHAMPIX 2 [0.05%]; placebo 2 [0.07%]) in the CHAMPIX arms compared with the placebo arms in the meta-analysis.
Danish: I meta-analysen var forekomsten af dødsfald (alle årsager) (CHAMPIX 6 (0,14%); placebo 7 (0,25%)) og kardiovaskulære dødsfald (CHAMPIX 2 (0,05%); placebo 2 (0,07%)) i sammenlignelige i CHAMPIX-armen og i placebo-armen.
English: During non-treatment follow up to 52 weeks, the adjudicated events included need for coronary revascularisation (2.0% vs. 0.6%), hospitalisation for angina pectoris (1.7% vs. 1.1%), and new diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure (1.4% vs. 0.6%).
Danish: I løbet af opfølgningsperioden uden behandling ind til uge 52 omfattede de hændelser, der blev betragtet som værende relateret til behandlingen: Behov for koronar revaskularisering (2,0% vs. 0,6%), hospitalsindlæggelse for angina pectoris (1,7% vs. 1.1%) og nydiagnosticeret perifer vaskulær sygdom (PVD) eller indlæggelse for PVD-operation (1,4% vs. 0,6%).
English: The key cardiovascular safety analysis included occurrence and timing of a composite endpoint of Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, nonfatal MI, and nonfatal stroke.
Danish: Den vigtigste sikkerhedsanalyse omfattede hændelse og timing af et sammensat endepunkt af alvorlige kardiovaskulære bivirkninger (Major Adverse Cardiovascular Events (MACE)), defineret som kardiovaskulær død, non-letal myokardieinfarkt og non-letal apopleksi.
English: Numbers 1 to 28 sun as symbol moon as symbol
Danish: Nummereret 1 - 28 sol som symbol måne som symbol
English: Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with CHAMPIX in the post-marketing experience.
Danish: Efter markedsføring er der rapporteret om ændringer i adfærd eller tankegang, angst, psykose, humørsvingninger, aggressiv adfærd, depression, selvmordstanker og selvmordsadfærd samt selvmordsforsøg hos patienter, der forsøgte at holde op med at ryge ved hjælp af CHAMPIX.
English: Seizure, tremor, lethargy, hypoaesthesia
Danish: Kramper, tremor, letargi, hypæstesi
English: From day 1 to day 3, you should take one white CHAMPIX 0.5 mg film-coated tablet once a day.
Danish: Fra dag 1-3 skal De tage 1 hvid CHAMPIX 0,5 mg filmovertrukken tablet 1 gang dagligt
English: The results for the 4W CQR (weeks 9 through 12) and CA rate (weeks 9 through 52) are shown in the following table:
Danish: Resultaterne for 4W-CQR (uge 9 til og med uge 12) og CA (uge 9 til og med uge 52) fremgår af tabellen herunder.
English: Children and adolescents CHAMPIX is not recommended for use in paediatric patients as efficacy was not demonstrated.
Danish: CHAMPIX anbefales ikke til pædiatriske patienter, da der ikke er påvist virkning.
English: NRT=Nicotine replacement therapy patch
Danish: NRT = nikotinplaster (nicotine replacement therapy patch)
English: In patients with moderate renal impairment (estimated creatinine clearance  30 ml/min and  50 ml/min), varenicline exposure increased 1.5-fold compared with subjects with normal renal function (estimated creatinine clearance > 80 ml/min).
Danish: Hos patienter med moderat nedsat nyrefunktion (anslået kreatininclearance ≥30 ml/min og 50 ml/min) var vareniclinniveauet øget 1,5 gange sammenlignet med patienter med normal nyrefunktion (anslået kreatininclearance >80 ml/min).
English: Gradual approach to quitting smoking
Danish: Gradvis metode til at stoppe med at ryge
English: The following table shows the rates of the composite NPS adverse event primary endpoint by treatment group and the risk differences (RDs) (95% CI) vs placebo in the non-psychiatric cohort.
Danish: Følgende tabel viser hyppigheden af det sammensatte primære endepunkt for NPS bivirkninger ifølge behandlingsgruppe og risikodifferenser (RD'er) (95 % CI) vs placebo i den ikke-psykiatriske kohorte.
English: Due to the absence of significant hepatic metabolism, varenicline pharmacokinetics should be unaffected in patients with hepatic impairment (see section 4.2).
Danish: På grund af fraværet af signifikant hepatisk metabolisme er vareniclins farmakokinetik upåvirket hos patienter med nedsat leverfunktion (se pkt.
English: The most common adverse events (≥ 10%) in subjects taking varenicline were nausea (27.0% vs. 10.4% on placebo), headache (16.8% vs. 11.2%), abnormal dreams (11.3% vs. 8.2%), insomnia (10.9% vs. 4.8%) and irritability (10.9% vs. 8.2%).
Danish: De hyppigste bivirkninger (≥ 10 %) hos patienter, der tog vareniclin, var kvalme (27,0 % vs. 10,4 % i placebo-gruppen), hovedpine (16,8 % vs. 11,2 %), drømmeforstyrrelser (11,3 % vs. 8,2 %), søvnløshed (10,9 % vs. 4,8 %) og irritabilitet (10,9 % vs. 8,2 %).
English: In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Danish: In vitro-forsøg tyder på, at det er usandsynligt, at vareniclin ændrer farmakokinetikken for stoffer, der primært metaboliseres af CYP450-enzymer.
English: Indigo Carmine Aluminium Lake (E132) Triacetin
Danish: Indigotin I (E132) Triacetin
English: Depression a
Danish: Depression
English: 42 x 1 mg film-coated tablets
Danish: 42 x 1 mg filmovertrukne tabletter
English: Cellulose, Microcrystalline Calcium Hydrogen Phosphate Anhydrous Croscarmellose Sodium Silica, Colloidal Anhydrous Magnesium Stearate
Danish: Cellulose, mikrokrystallinsk Calciumhydrogenphosphat, vandfri Croscarmellosenatrium Silica, kolloid vandfri Magnesiumstearat
English: The use of varenicline, bupropion and NRT in the non-psychiatric cohort was not associated with a significantly increased risk of NPS adverse events in the composite primary endpoint compared with placebo (95% CIs were lower than or included zero).
Danish: Brugen af vareniclin, bupropion og nikotinplaster i den ikke-psykiatriske kohorte var ikke forbundet med en øget risiko for NPS bivirkninger i det sammensatte primære endepunkt sammenlignet med placebo (95 % CI var lavere end eller inkluderede nul).
English: Study in subjects with a history of major depressive disorder The efficacy of varenicline was confirmed in a randomised placebo-controlled trial in 525 subjects with a history of major depression in the past two years or under current stable treatment.
Danish: Virkningen af vareniclin blev bekræftet i et randomiseret, placebokontrolleret studie med 525 patienter med svær depression inden for de seneste 2 år eller i stabil behandling for depression.
English: Examples include theophylline (a medicine to treat breathing problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine to treat diabetes).
Danish: Det kan i nogle tilfælde være nødvendigt at ændre dosis af anden medicin, f.eks. theofyllin (medicin til behandling af vejrtrækningsbesvær), warfarin (blodfortyndende medicin) og insulin (medicin til behandling af sukkersyge), i forbindelse med at holde op med at ryge.
English: Metformin had no effect on varenicline pharmacokinetics.
Danish: Metformin har ingen effekt på vareniclins farmakokinetik.
English: The third study reported no difference in risk of psychiatric adverse events diagnosed during an emergency department visit or inpatient admission between varenicline users and bupropion users (HR 0.85; 95% CI: 0.55-1.30).
Danish: Det tredje studie viste ingen forskel i risikoen for psykiatriske bivirkninger, diagnosticeret under et besøg på en akutafdeling eller ved indlæggelse, hos vareniclinbrugere sammenlignet med bupropionbrugere (HR 0,85; 95% CI: 0,55-1,30).
English: Hallucinationsb Homicidal ideationb Maniab
Danish: Vrangforestillinger Hallucinationer Suicidaltanker Mani
English: In the offspring of pregnant rats treated with varenicline there were decreases in fertility and increases in the auditory startle response (see section 4.6).
Danish: Afkom fra rotter, der får vareniclin, mens de er drægtige, udviser nedsat fertilitet og øget ”auditory startle response” (se pkt.
English: The following table shows the rates of the composite NPS adverse event primary endpoint by treatment group and the RDs (95% CI) vs placebo in the psychiatric cohort.
Danish: Følgende tabel viser hyppigheden af det sammensatte primære endepunkt for NPS bivirkninger ifølge behandlingsgruppe og RD'er (95 % CI) vs placebo i den psykiatriske kohorte.
English: Also, in human hepatocytes in vitro, varenicline was shown to not induce the activity of cytochrome P450 enzymes 1A2 and 3A4.
Danish: In vitro inducerede vareniclin desuden ikke aktiviteten af CYP450-enzymerne 1A2 og 3A4 i humane hepatocytter.
English: This study showed the benefit of an additional 12-week treatment with CHAMPIX 1 mg twice daily for the maintenance of smoking cessation compared to placebo; superiority to placebo for CA was maintained through week 52.
Danish: Dette studie viste den gavnlige virkning af yderligere 12 ugers behandling med CHAMPIX 1 mg 2 gange dagligt for at fastholde rygeophør sammenlignet med placebo.
English: Platelet count decreased Metabolism and nutrition disorders Common
Danish: Nedsat antal blodplader Metabolisme og ernæring Almindelig
English: In this group, the discontinuation rates for the most common adverse reactions in varenicline treated patients were as follows: nausea (2.7% vs. 0.6% for placebo), headache (0.6% vs. 1.0% for placebo), insomnia (1.3% vs. 1.2% for placebo), and abnormal dreams (0.2% vs. 0.2% for placebo).
Danish: I denne gruppe er seponeringsraten for de hyppigste bivirkninger hos patienter, der blev behandlet med vareniclin: kvalme (2,7% versus 0,6% for placebo), hovedpine (0,6% versus 1,0% for placebo), søvnløshed (1,3% versus 1,2% for placebo) og unormale drømme (0,2% versus 0,2% for placebo).
English: The percentage of subjects with suicide-related events in the active treatment phase compared to post-treatment phase was unchanged in the varenicline group; in the placebo group, this percentage was lower in the post-treatment phase.
Danish: Procentdelen af patienter med selvmordsrelaterede hændelser i den aktive behandlingsfase sammenlignet med fasen efter behandling var uændret i vareniclin-gruppen.
English: Blood pressure increased, hot flush Respiratory, thoracic and mediastinal disorders Common
Danish: Forhøjet blodtryk, hedestigninger Luftveje, thorax og mediastinum Almindelig
English: Odds ratio (95% CI), p value
Danish: Oddsratio (95% CI), p-værdi
English: 4-week treatment initiation pack
Danish: 4-ugers startpakning
English: Rash, pruritus Erythema, acne, hyperhidrosis, night sweats
Danish: Erytem, akne, hyperhidrose, nattesved
English: Store below 30°C
Danish: Må ikke opbevares ved temperaturer over 30 °C.
English: In both cohorts, subjects treated with varenicline demonstrated statistical superiority of CO-confirmed abstinence during weeks 9 through 12 and 9 through 24 compared to subjects treated with bupropion, nicotine patch and placebo (please see table below).
Danish: CO-bekræftet afholdenhed i løbet af uge 9 til og med 12 og 9 til og med 24 sammenlignet med forsøgspersoner, der blev behandlet med bupropion, nikotinplaster og placebo (se nedenstående tabel).
English: In smoking cessation therapy, risk of returning to smoking may be elevated in the period immediately following the end of treatment.
Danish: Risikoen for at begynde at ryge igen efter behandling er højest i perioden umiddelbart efter, at behandlingen er slut.
English: High-Dose Varenicline Low-Dose Varenicline Placebo
Danish: Højdosis-vareniclin Lavdosis-vareniclin Placebo
English: Tell your doctor if you have experienced seizures or have epilepsy before your start CHAMPIX treatment.
Danish: Tal med lægen, før De starter behandlingen med CHAMPIX, hvis De har haft krampeanfald eller har epilepsi.
English: For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with CHAMPIX at 1 mg twice daily may be considered for the maintenance of abstinence (see section 5.1).
Danish: Patienter, der med succes er stoppet med at ryge efter 12 uger, kan overveje at tage yderligere en kur på 12 uger med CHAMPIX 1 mg 2 gange dagligt for at fastholde afholdenheden (se pkt.
English: Film-coated tablets
Danish: Filmovertrukkne tabletter
English: Non-clinical data revealed no hazard for humans based on standard male and female fertility studies in the rat (see section 5.3).
Danish: Prækliniske data afslørede ingen risiko hos mennesker baseret på standard-fertilitetsstudier hos hanog hunrotter (se pkt.
English: Continuous Abstinence Rates in Subjects Treated with Champix versus Placebo
Danish: Vedvarende afholdenhedsrate for forsøgspersoner, der fik CHAMPIX, sammenlignet med placebo
English: The primary endpoint of the study was the CO-confirmed, 4-week Continuous Quit Rate (4W CQR) from week 9 through week 12 and a key secondary endpoint was the Continuous Abstinence (CA) from Week 9 through Week 52.
Danish: Det primære endepunkt var en CO-bekræftet 4W-CQR fra uge 9 til og med uge 12 og et sekundært endepunkt var CA fra uge 9 til og med uge 52.
English: In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).
Danish: Hos patienter med nyresygdom i sidste stadie blev vareniclin effektivt fjernet ved dialyse (se pkt.
English: 12-to-17-Year Olds n/N (%)
Danish: 12 til 17 år n/N (%)
English: The primary endpoint of the two studies was the carbon monoxide (CO) confirmed, 4-week continuous quit rate (4W-CQR) from week 9 through week 12.
Danish: Det primære endepunkt for de 2 studier, er den 4 ugers vedvarende kvit-rate (4-week Continuous Quit Rate, 4W-CQR) fra uge 9 til og med uge 12, som er bekræftet ved måling af carbonmonoxid (CO).
English: The most common adverse events in subjects taking varenicline were nausea (23.8% vs. 14.0% on placebo), headache (10.7% vs. 18.6% on placebo) and vomiting (10.7% vs. 9.3% on placebo).
Danish: De hyppigste bivirkninger i vareniclin-gruppen var kvalme (23,8% vs. 14,0% i placebo-gruppen), hovedpine (10,7% vs. 18,6% i placebo-gruppen) og opkastning (10,7% vs. 9,3% i placebo-gruppen).
English: Gastrooesophageal reflux disease, vomiting, constipation, diarrhoea, abdominal distension, abdominal pain, toothache, dyspepsia, flatulence, dry mouth
Danish: Gastroøsofageal reflukssygdom, opkastning, forstoppelse, diarré, udspilet abdomen, abdominalsmerter, tandpine, dyspepsi, flatulens, mundtørhed
English: During treatment Number assessed Suicidal behaviour and/or ideation Suicidal behaviour Suicidal ideation During follow up Number assessed Suicidal behaviour and/or ideation Suicidal behaviour Suicidal ideation
Danish: Under behandlingen Antal vurderet Suicidaladfærd og/eller -tanker Suicidaladfærd Suicidaltanker Under opfølgning Antal vurderet Suicidaladfærd og/eller -tanker Suicidaladfærd Suicidaltanker
English: Non-psychiatric Cohort N=3984 Varenicline Bupropion
Danish: Ikke-psykiatrisk kohorte N=3984 Vareniclin Bupropion Nikotinplaster Placebo
English: Varenicline (N=5072)
Danish: Vareniclin (n=5.072)
English: Day 8 - 14 From day 8 to day 14, you should take one light blue CHAMPIX 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Danish: Dag 8-14 Fra dag 8-14 skal De tage 1 lyseblå CHAMPIX 1 mg filmovertrukken tablet 2 gange dagligt, 1 om morgenen og 1 om aftenen på omtrent samme tidspunkt hver dag
English: Single and multiple-dose pharmacokinetics of varenicline have been investigated in paediatric patients aged 12 to 17 years old (inclusive) and were approximately dose-proportional over the 0.5 mg to 2 mg daily dose range studied.
Danish: Efter enkeltdosis og efter multiple doser til pædiatriske patienter i alderen 12-17 år (begge inklusive) var vareniclins farmakokinetik stort set dosis-proportional i det undersøgte dosisinterval på 0,5-2 mg dagligt.
English: Some people have reported seizures while taking CHAMPIX.
Danish: Nogle personer har oplevet krampeanfald, mens de var i behandling med CHAMPIX.
English: Hepatic impairment No dosage adjustment is necessary for patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: Psychiatric Cohort N=4074 Varenicline Bupropion
Danish: Psykiatrisk kohorte N=4074 Vareniclin Bupropion Nikotinplaster Placebo
English: CA = continuous abstinence rate; CI = confidence interval; NRT=Nicotine replacement therapy patch
Danish: CA = vedvarende afholdenhedsrate (continuous abstinence rate), CI = konfidensinterval, NRT = nikotinplaster (nicotine replacement therapy patch)
English: Varenicline did not alter the pharmacokinetics of warfarin.
Danish: Vareniclin ændrer ikke farmakokinetikken for warfarin.
English: When 0.5 mg twice daily was given, steady-state daily exposure of varenicline was, on average, higher (by approximately 40%) in adolescent patients with bodyweight ≤ 55 kg compared to that noted in the adult population.
Danish: Hos unge med legemsvægt ≤55 kg blev der efter indgift af 0,5 mg 2 gange dagligt set et vareniclin-niveau ved steadystate, der gennemsnitligt var højere (ca. 40%) sammenlignet med voksne.
English: Number of Patients Treated 990 Composite NPS AE Primary Endpoint, n (%)
Danish: Antal behandlede patienter Sammensat primært endepunkt for NPS AE n (%)
English: 11 x 0.5 mg and 14 x 1 mg
Danish: Filmovertrukne tabletter 11 x 0,5 mg og 14 x 1 mg
English: Subjects were randomised to CHAMPIX 1 mg twice daily (n=353) or placebo (n=350) for 12 weeks and then were followed for 40 weeks post-treatment.
Danish: Patienterne blev randomiseret til CHAMPIX 1 mg 2 gange dagligt (n=353) eller placebo (n=350) i 12 uger og blev derefter fulgt i 40 uger efter behandling.
English: Treatment discontinuation
Danish: Fastholdelse af afholdenhed
English: From day 15 until the end of treatment, you should take one light blue CHAMPIX 1 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Danish: Fra dag 15 og til behandlingen er slut, skal De tage 1 lyseblå CHAMPIX 1 mg filmovertrukken tablet 2 gange dagligt, 1 om morgenen og 1 om aftenen på omtrent samme tidspunkt hver dag
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis De glemmer at tage en dosis, bør De tage den straks, De kommer i tanke om det, medmindre der kun er 3-4 timer til at næste dosis skal tages.
English: Study in subjects with stable schizophrenia or schizoaffective disorder Varenicline safety and tolerability was assessed in a double-blind study of 128 smokers with stable schizophrenia or schizoaffective disorder, on antipsychotic medication, randomised 2:1 to varenicline (1 mg twice daily) or placebo for 12 weeks with 12-week non-drug follow-up.
Danish: Patienter med stabil skizofreni eller skizoaffektiv sindslidelse Vareniclins sikkerhed og tolerabilitet blev undersøgt i et dobbelt-blindet studie med 128 rygere med stabil skizofreni eller skizoaffektiv sindslidelse, der fik antipsykotika.
English: It has been shown in clinical trials that taking all doses of your medicine at the appropriate times and for the recommended duration of treatment described above will increase your chances of stopping smoking.
Danish: Kliniske forsøg har vist, at det vil forøge Deres chancer for at holde op med at ryge, hvis alle doser tages på de fastsatte tidspunkter og i den periode, som bliver foreslået.
English: CHAMPIX also significantly reduced reinforcing effects of smoking that can perpetuate smoking behaviour in patients who smoke during treatment compared with placebo.
Danish: Sammenlignet med placebo har CHAMPIX desuden en signifikant reducerende effekt på de forstærkende virkninger af rygningen, der kan føre til, at de patienter, der ryger under behandlingen, ikke kan komme af med deres rygevaner.
English: The 4 week CQR for varenicline and placebo was 47.3% and 14.3%, respectively and the CA week 9-52 was 19.8% (varenicline) vs. 7.4% (placebo).
Danish: 4W-CQR for vareniclin og placebo var hhv. 47,3% og 14,3% og CA uge 9-52 var 19,8% (vareniclin) vs. 7,4% (placebo).
English: Champix is for oral use.
Danish: CHAMPIX er beregnet til at tage gennem munden.
English: For example, dysphoric or depressed mood; insomnia, irritability, frustration or anger; anxiety; difficulty concentrating; restlessness; decreased heart rate; increased appetite or weight gain have been reported in patients attempting to stop smoking.
Danish: Eksempelvis er følgende symptomer set hos patienter, der prøvede på at holde op med at ryge: dysfori og nedtrykt sindstilstand; søvnløshed, irritabilitet, frustration eller vrede; angst; koncentrationsbesvær; rastløshed; nedsat hjerterytme; øget appetit eller vægtøgning.
English: From day 4 to day 7, you should take one white CHAMPIX 0.5 mg film-coated tablet twice daily, once in the morning and once in the evening, at about the same time each day.
Danish: Fra dag 4-7 skal De tage 1 hvid CHAMPIX 0,5 mg filmovertrukken tablet 2 gange dagligt, 1 om morgenen og 1 om aftenen på omtrent samme tidspunkt hver dag
English: Varenicline did not affect the pharmacokinetics of metformin.
Danish: Vareniclin påvirker ikke farmakokinetikken for metformin.
English: White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side.
Danish: Hvide, kapselformede, bikonvekse tabletter præget ”Pfizer” på den ene side og ”CHX 0.5” på den anden side.
English: Subjects were randomised to either CHAMPIX 1 mg twice daily (n=760) or placebo (n=750) for 24 weeks and followed up post-treatment through week 52.
Danish: Forsøgspersonerne blev randomiseret til at få enten CHAMPIX 1 mg to gange dagligt (n=760) eller placebo (n=750) i 24 uger og blev fulgt efter behandlingen til og med uge 52.
English: In this 24-week study, patients received treatment for 12 weeks followed by a 12 week non-treatment follow up phase.
Danish: I dette 24-ugers studie fik patienterne behandling i 12 uger efterfulgt af en 12-ugers opfølgningsfase uden behandling.