FrancophonIA/ELRC3.0 huggingface dataset:
English: How to take CHAMPIX
Danish: Sådan skal De tage CHAMPIX
English: hallucinations, changes in sex drive o Seizure, tremor, feeling sluggish, less sensitive to touch o Conjunctivitis, eye pain o Ringing in the ears o Angina, rapid heart rate, palpitations, increased heart rate o Increased blood pressure, hot flush o Inflammation of nose, sinuses and throat, congestion of nose, throat and chest,
Danish: hallucinationer, ændringer i seksuel aktivitet - Krampeanfald, rysten, træthedsfornemmelse, nedsat følesans - Konjunktivitis, øjensmerter - Ringen for ørene (tinnitus) - Brystsmerter, hurtige hjerteslag, hurtig puls, hjertebanken - Forhøjet blodtryk, hedestigninger - Betændelse i næse, bihuler eller hals, tilstoppet næse, hals eller bryst, hæshed, høfeber,
English: AE, adverse event; aGrade = severe intensity AE; bGrade = moderate and severe intensity AE; NRT=Nicotine replacement therapy patch
Danish: bGrad = AE af moderat og svær intensitet, NRT = nikotinplaster (nicotine replacement therapy patch)
English: High-Dose Varenicline vs Placebo Low-Dose Varenicline vs Placebo
Danish: Højdosis-vareniclin vs. placebo Lavdosis-vareniclin vs. placebo
English: Continuous abstinence rate between weeks 9-12 was 35.9% in the varenicline treatment group versus 15.6% in the placebo group (OR 3.35 (95% CI 2.16-5.21)) and between weeks 9-52 was 20.3% versus 10.4% respectively (OR 2.36 (95% CI 1.40-3.98)).
Danish: CA-raten mellem uge 9 og 12 var 35,9 % i vareniclin-armen sammenlignet med 15,6 % i placebo-armen (OR 3,35 (95 % CI 2,16-5,21)), og CA-raten mellem uge 9 og 52 hhv. 20,3 % og 10,4 % (OR 2,36 (95 % CI 1,40-3,98)).
English: Very common Nausea
Danish: Meget almindelig Hovedpine Almindelig
English: Suicidal ideation, aggression, panic reaction, thinking abnormal, restlessness, mood swings, depression*, anxiety*, hallucinations*, libido increased, libido decreased Psychosis, somnambulism, abnormal behaviour, dysphoria, bradyphrenia Nervous system disorders Very common Headache Common
Danish: Selvmordstanker, aggression, panikanfald, abnorm tankegang, rastløshed, humørsvingninger, depression*, angst*, hallucinationer*, øget libido, nedsat libido
English: Fungal infection, viral infection Blood and lymphatic system disorders Rare
Danish: Blod- og lymfesystem Sjælden
English: Based on insufficient clinical experience with CHAMPIX in patients with end stage renal disease, treatment is not recommended in this patient population (see section 5.2).
Danish: Behandling med CHAMPIX af patienter med nyresygdom i sidste stadie kan ikke anbefales, på grund af utilstrækkelig klinisk erfaring med denne patientgruppe (se pkt.
English: CA Wk 9-52
Danish: CA Uge 9-52
English: Cerebrovascular accident, hypertonia, dysarthria, coordination abnormal, hypogeusia, circadian rhythm sleep disorder Transient loss of consciousness
Danish: Cerebrovaskulær hændelse, hypertoni, dysartri, koordinationsforstyrrelser, hypogeusi, forstyrrelse i den cirkadiske søvn-vågencyklus
English: The 4 week (week 9-12) CQR for varenicline and placebo was 53.9% and 19.4%, respectively (difference=34.5%, 95% CI: 27.0%42.0%) and the CA week 9-24 was 35.2% (varenicline) vs. 12.7% (placebo) (difference=22.5%, 95% CI: 15.8% - 29.1%).
Danish: 4W-CQR (uge 9-12) for vareniclin og placebo var hhv. 53,9% og 19,4% (difference = 34,5%; 95% CI: 27,0%-42,0%) og CA uge 9-24 var 35,2% (vareniclin) vs. 12,7% (placebo) (difference = 22,5%; 95% CI: 15,8%-29,1%).
English: Heart symptoms
Danish: Angstlidelser og -symptomer
English: In subjects with severe renal impairment (estimated creatinine clearance < 30 ml/min), varenicline exposure was increased 2.1-fold.
Danish: Hos patienter med alvorligt nedsat nyrefunktion (anslået kreatininclearance <30 ml/min) er vareniclinniveauet øget 2,1 gange.
English: Subjects treated with CHAMPIX had a significantly higher Continuous Abstinence Rate compared with placebo; the key results are summarised in the following table:
Danish: Forsøgspersoner, der blev behandlet med CHAMPIX, opnåede en væsentlig højere vedvarende afholdenhedsrate sammenlignet med dem placebogruppen.
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Hvis De er i tvivl så spørg lægen eller apoteket.
English: Analyses of clinical trial data did not show evidence of an increased risk of serious neuropsychiatric events with varenicline compared to placebo.
Danish: Neuropsykiatrisk sikkerhed - metaanalyser og observationsstudier Analyser af data fra kliniske studier viste ikke evidens for øget risiko for svære neuropsykiatriske hændelser med vareniclin sammenlignet med placebo.
English: AE, adverse event; NRT=Nicotine replacement therapy patch
Danish: AE = bivirkning, NRT = Nikotinplaster (nicotine replacement therapy patch)
English: The use of varenicline in patients with or without a history of psychiatric disorder was not associated with an increased risk of serious neuropsychiatric adverse events in the composite primary endpoint compared with placebo (see section 5.1 Pharmacodynamic properties - Study in Subjects with and without a History of Psychiatric Disorder).
Danish: Brugen af vareniclin hos patienter med eller uden tidligere psykisk forstyrrelse var ikke forbundet med en øget risiko for alvorlige, neuropsykiatriske bivirkninger i det sammensatte, primære endepunkt sammenlignet med placebo (se pkt.
English: There were more events reported in patients in the psychiatric cohort in each treatment group compared with the non-psychiatric cohort, and the incidence of events in the composite endpoint was higher for each of the active treatments compared to placebo.
Danish: Der blev rapporteret flere hændelser for patienter i den psykiatriske kohorte i hver behandlingsgruppe sammenlignet med den ikke-psykiatriske kohorte.
English: NRT N=1006 n (%)
Danish: N=1006 n (%)
English: 11 x 0.5 mg film-coated tablets and
Danish: Indeholder: 11 x 0,5 mg filmovertrukne tabletter og
English: Composite NPS AE Endpoint of severe intensity n (%)
Danish: Sammensat endepunkt for NPS AE af svær grad, n (%)
English: NRT N=2022
Danish: Nikotinplaster N=2022
English: The effects of stopping smoking
Danish: Effekten af at holde op med at ryge
English: 0.5 mg film-coated tablets of 4mm x 8mm: White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side.
Danish: 0,5 mg filmovertrukne tabletter på 4 mm x 8 mm: Hvide, kapselformede, bikonvekse tabletter præget ”Pfizer” på den ene side og ”CHX 0.5” på den anden side.
English: Odds ratio (95% CI)
Danish: Oddsratio (95% CI)
English: Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upperairway cough syndrome, rhinorrhoea Laryngeal pain, snoring
Danish: Inflammation i de øvre luftveje, tilstopning af luftveje, dysfoni, allergisk rhinitis, halsirritation, tilstoppede bihuler, øvre luftvejhoste-syndrom (upper-airway cough syndrom), næseflåd
English: Neuropsychiatric Safety Study in Subjects with and without a History of Psychiatric Disorder:
Danish: Kardiovaskulær sikkerhedsvurderingsstudie med forsøgspersoner med eller uden en psykiatrisk lidelse i anamnesen
English: Tablet film coating - CHAMPIX 1 mg film-coated tablets Hypromellose
Danish: Filmovertræk - CHAMPIX 1 mg filmovertrukne tabletter Hypromellose
English: Subjects were randomised 1:1 to CHAMPIX 1 mg twice daily (N=249) or placebo (N=245) for 12 weeks of treatment and followed for up to 40 weeks post-treatment.
Danish: Forsøgspersonerne blev randomiseret 1:1 til behandling i 12 uger med CHAMPIX 1 mg to gange dagligt (n=249) eller placebo (n=245) og blev fulgt i op til 40 uger efter behandlingen.
English: CHAMPIX is available in the following pack presentations:
Danish: CHAMPIX indeholder:
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA Holder Logo)
Danish: Pfizer Europe MA EEIG (som logo for indehaver af markedsføringstilladelse)
English: Chest pain, fatigue
Danish: Brystsmerter, træthed
English: Giving up smoking with or without treatment can cause various symptoms.
Danish: Rygeophør kan give forskellige symptomer, hvad enten det gennemføres med eller uden behandling.
English: CHAMPIX is not recommended for use in paediatric patients because its efficacy in this population was not demonstrated (see sections 5.1 and 5.2).
Danish: Det frarådes at anvende CHAMPIX hos pædiatriske patienter, eftersom der ikke er påvist virkning i denne population (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS 56 Film-coated tablets
Danish: Vedligeholdelsespakning indeholdende 56 filmovertrukne tabletter
English: No dosage adjustment of CHAMPIX or co-administered medicinal products listed below is recommended.
Danish: CHAMPIX og de nedenfor nævnte lægemidler, kan administreres samtidigt, uden det er nødvendigt at dosisjustere.
English: Tablet film coating - CHAMPIX 0.5 mg film-coated tablets Hypromellose
Danish: Filmovertræk - CHAMPIX 0,5 mg filmovertrukne tabletter Hypromellose
English: Treated Composite NPS AE
Danish: Sammensat primært endepunkt for NPS AE, n
English: Light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side.
Danish: Lyseblå, kapselformede, bikonvekse tabletter præget ”Pfizer” på den ene side og ”CHX 1.0” på den anden side.
English: NRT N=1016 n (%)
Danish: N=1016 n (%)
English: 28 film-coated tablets
Danish: Vedligeholdelsespakning indeholdende 28 filmovertrukne tabletter
English: Carton pack containing 2 blister packs of 14 x 1 mg varenicline film-coated tablets or 4 blister packs of 14 x 1 mg varenicline film-coated tablets or 8 blister packs of 14 x 1 mg varenicline film-coated tablets or 10 blister packs of 14 x 1 mg varenicline film-coated tablets
Danish: Karton indeholdende 2 blisterkort hver med 14 x 1 mg vareniclin filmovertrukne tabletter eller 4 blisterkort hver med 14 x 1 mg vareniclin filmovertrukne tabletter eller 8 blisterkort hver med 14 x 1 mg vareniclin filmovertrukne tabletter eller 10 blisterkort hver med 14 x 1 mg vareniclin filmovertrukne tabletter
English: Varenicline did not alter the steady-state pharmacokinetics of digoxin.
Danish: Vareniclin ændrer ikke farmakokinetikken for digoxin i steady state.
English: pain in the gums o Reddening of the skin, acne, increased sweating, night sweats o Muscle spasms, chest wall pain o Abnormally frequent urination, urination at night o Increased menstrual flow o Chest discomfort, flu like illness, fever, feeling weak or unwell o High blood sugar o Heart attack o Suicidal thoughts o Changes in thinking or behaviour (such as aggression)
Danish: irriteret hals, tilstoppede bihuler, hoste forårsaget af øget slimdannelse i næsen, løbenæse - Rødt blod i afføringen, maveirritation, ændrede afføringsvaner, bøvsen, mundsår, smerter i gummerne - Hudrødmen, bumser, øget svedtendens, nattesved - Muskelspasmer, smerter i brystkassen - Unormal, hyppig vandladning, natlig vandladning - Kraftigere menstruation - Ubehag i brystet, influenzalignende symptomer, feber, svaghedsfølelse eller følelse af ubehag - Højt blodsukker - Hjerteanfald - Selvmordstanker - Ændret tankegang og adfærd (f.eks. aggressiv og unormal adfærd).
English: The effects of changes in your body resulting from stopping smoking, with or without treatment with CHAMPIX, may alter the way other medicines work.
Danish: Rygeophør kan føre til ændringer i Deres krop, og det kan ændre virkningen af anden medicin.
English: Varenicline did not alter the steady-state pharmacokinetics of bupropion.
Danish: Vareniclin ændrer ikke farmakokinetikken af bupropion i steady state.
English: For patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended dose of CHAMPIX is 1 mg once daily.
Danish: Den anbefalede dosis af CHAMPIX hos patienter med svært nedsat nyrefunktion (anslået kreatininclearance <30 ml/min) er 1 mg 1 gang dagligt.
English: If in doubt, you should consult your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apotekspersonalet.
English: 1 mg film-coated tablets of 5mm x 10mm: Light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side.
Danish: 1 mg filmovertrukne tabletter på 5 mm x 10 mm: Lyseblå, kapselformede, bikonvekse tabletter præget ”Pfizer” på den ene side og ”CHX 1.0” på den anden side.
English: Bupropion N=1017 n (%)
Danish: N=1017 n (%)
English: Bupropion N=989 n (%)
Danish: N=989 n (%)
English: CHAMPIX 0.5 mg CHAMPIX 1 mg Film-coated tablets Varenicline
Danish: CHAMPIX 0,5 mg CHAMPIX 1 mg Filmovertrukne tabletter Vareniclin
English: There have been post marketing reports of increased intoxicating effects of alcohol in patients treated with varenicline.
Danish: Efter markedsføringen er der rapporteret om en øget berusende virkning af alkohol hos patienter, der blev behandlet med vareniclin, men der er ikke etableret en årsagssammenhæng.
English: This medicine has been prescribed for you only.
Danish: Lægemidlet er receptpligtigt.
English: CA* wk 21-52
Danish: CA* uge 13-52
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest ændret <{måned ÅÅÅÅ}.>
English: CHAMPIX can help to relieve the craving and withdrawal symptoms associated with stopping smoking.
Danish: CHAMPIX kan virke dæmpende på Deres trang til at ryge, samtidig med at den lindrer de abstinenssymptomer, der opstår, når De holder op med at ryge.
English: The efficacy of CHAMPIX in smoking cessation is a result of varenicline's partial agonist activity at the α4β2 nicotinic receptor where its binding produces an effect sufficient to alleviate symptoms of craving and withdrawal (agonist activity), while simultaneously resulting in a reduction of the rewarding and reinforcing effects of smoking by preventing nicotine binding to α4β2 receptors (antagonist activity).
Danish: Ved at hindre nicotin i at virke på α4β2-receptorerne (antagonist virkning) nedsætter det samtidig belønningsoplevelsen og rygningens selvforstærkende mekanisme.
English: Panic b
Danish: BILAG I
English: During treatment MACE, n (%)
Danish: MACE, n (%)
English: For elderly patients with reduced renal function please refer to section 4.2.
Danish: For ældre patienter med nedsat nyrefunktion se pkt.
English: A key secondary endpoint was the continuous abstinence (CA) rate for week 13 through week 52.
Danish: De vigtigste sekundære endepunkter var CA for uge 13 til og med uge 52.
English: - Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate).
Danish: Hver 0,5 mg filmovertrukken tablet indeholder 0,5 mg vareniclin (som tartrat).
English: CHAMPIX 1 mg film-coated tablets are light blue film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 1.0”
Danish: - CHAMPIX 1 mg filmovertrukne tabletter er lyseblå, filmovertrukne, kapselformede tabletter, mærket ”Pfizer” på den ene side og ”CHX 1.0” på den anden.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER TRIP
English: High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil/polyethylene induction seal containing 56 x 0.5 mg film-coated tablets Not all pack sizes may be marketed.
Danish: HDPE beholder med polypropylen børnesikret lukning og aluminiumsfolie/polyethylen forsegling, indeholdende 56 x 0,5 mg filmovertrukne tabletter.
English: Number assessed Suicidal behaviour and/or ideation Suicidal behaviour Suicidal ideation
Danish: Suicidaladfærd og/eller -tanker Suicidaladfærd Suicidaltanker
English: Follow-on (maintenance) packs containing 2 or 4 clear blisters of 14 or 2 clear blisters of 28 x CHAMPIX 0.5 mg film-coated tablets in card packaging.
Danish: - Vedligeholdelsespakninger, der indeholder 2 eller 4 gennemsigtige blisterkort hver med 14 eller 2 gennemsigtige blisterkort med 28 x CHAMPIX 0,5 mg filmovertrukne tabletter i en kortpakning.
English: In patients with severe renal impairment, the concomitant use of cimetidine and varenicline should be avoided.
Danish: Samtidig behandling med cimetidin og vareniclin bør undgås hos patienter med svært nedsat nyrefunktion.
English: Pollakiuria, nocturia
Danish: Pollakisuri, nykturi
English: Adverse Drug Reactions
Danish: Allergiske reaktioner
English: Carton pack with 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets
Danish: Karton indeholdende 1 blisterkort med 11 x 0,5 mg vareniclin filmovertrukne tabletter og 1 blisterkort med 14 x 1 mg vareniclin filmovertrukne tabletter
English: Varenicline has been shown to be dialyzed in patients with end stage renal disease (see section 5.2), however, there is no experience in dialysis following overdose.
Danish: Vareniclin kan fjernes ved dialyse, hvilket blev vist hos patienter med nyresygdom i sidste stadie (se pkt.
English: Varenicline binds with high affinity and selectivity at the α4β2 neuronal nicotinic acetylcholine receptors, where it acts as a partial agonist - a compound that has both agonist activity, with lower intrinsic efficacy than nicotine, and antagonist activities in the presence of nicotine.
Danish: Her virker det som en partiel agonist, det vil sige en forbindelse, der både viser agonist-virkning, men som er mindre virkningsfuld end nicotin, og som har antagonist-virkning ved tilstedeværelse af nicotin.
English: Odds ratio
Danish: Oddsratio
English: Completed suicideb Composite NPS AE Endpoint of severe intensity n (%)
Danish: Suicidal adfærd Suicidaltanker Gennemført selvmord Sammensat endepunkt for NPS AE af svær grad, n
English: High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil / polyethylene induction seal containing 56 x 1 mg film-coated tablets Not all pack sizes may be marketed.
Danish: HDPE beholder med polypropylen børnesikret lukning og aluminiumsfolie/polyethylen forsegling, indeholdende 56 x 1 mg filmovertrukne tabletter.
English: Uncommon: may affect up to 1 in 100 people o Fungal infection, viral infection o Feeling of panic, difficulty thinking, restlessness, mood swings, depression, anxiety,
Danish: - Svampeinfektion, virusinfektion - Panikanfald, vanskelighed ved at tænke, rastløshed, humørsvingninger, depression, angst,
English: - Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
Danish: Hver 1 mg filmovertrukken tablet indeholder 1 mg vareniclin (som tartrat).
English: Follow-on (maintenance) packs containing 2, 4, 8, or 10 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
Danish: - Vedligeholdelsespakninger, der indeholder 2, 4, 8 eller 10 gennemsigtige blisterkort hver med 14 x 1 mg filmovertrukne tabletter i en karton.
English: History of psychiatric disorders
Danish: Tidligere psykiske forstyrrelser
English: Treatment initiation packs:
Danish: Startpakninger:
English: 1.74 (1.43, 2.10), P<0.0001
Danish: 1,74 (1,43, 2,10), P<0,0001 1,62 (1,32, 1,99), P<0,0001
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg or 1 mg varenicline (as tartrate).
Danish: Hver tablet indeholder 0,5 mg eller 1 mg vareniclin (som tartrat).
English: What you need to know before you take CHAMPIX 3.
Danish: Det skal De vide, før De begynder at tage CHAMPIX Sådan skal De tage CHAMPIX Bivirkninger
English: In these 52 week duration studies, patients received treatment for 12 weeks, followed by a 40 week non-treatment phase.
Danish: I disse studier, der forløb over 52 uger, fik patienterne behandling i 12 uger efterfulgt af 40 uger uden behandling.
English: Chest discomfort, influenza like illness, pyrexia, asthenia, malaise Feeling cold, cyst
Danish: Ubehag i brystet, influenzalignende symptomer, pyreksi, asteni, utilpashed
English: Very common: may affect more than 1 in 10 people o Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache, o Nausea
Danish: - Betændelse i næse og hals, unormale drømme, søvnbesvær, hovedpine - Kvalme
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets
Danish: CHAMPIX 0,5 mg filmovertrukne tabletter CHAMPIX 1 mg filmovertrukne tabletter
English: 2.30 (1.83, 2.90), P<0.0001
Danish: 2,30 (1,83, 2,90), P<0,0001 2,00 (1,56, 2,55), P<0,0001
English: Liver function test abnormal
Danish: Abnorm levertest
English: 1.52 (1.23, 1.89), P=0.0001
Danish: 1,52 (1,23, 1,89), P=0,0001 1,51 (1,19, 1,93), P=0,0008
English: Follow-on (maintenance) packs containing 2 or 4 clear blisters of 14 or 2 clear blisters of 28 x CHAMPIX 1 mg film-coated tablets in card packaging.
Danish: - Vedligeholdelsespakninger, der indeholder 2 eller 4 gennemsigtige blisterkort hver med 14 eller 2 gennemsigtige blisterkort med 28 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning.
English: In this 52-week duration study, patients received treatment for 12 weeks, followed by a 40-week non-treatment follow-up phase.
Danish: I dette studie, der forløb over 52 uger, fik patienterne behandling i 12 uger efterfulgt af en behandlingsfri opfølgningsperiode på 40 uger.
English: Cardiovascular safety assessment study in subjects with and without a history of psychiatric disorder The cardiovascular (CV) safety of CHAMPIX was evaluated in the Study in Subjects with and without a History of Psychiatric Disorder (parent study; see section 5.1 - Neuropsychiatric safety) and its nontreatment extension, the Cardiovascular Safety Assessment Study, which enrolled 4595 of the 6293 subjects who completed the parent study (N=8058) and followed them through week 52.
Danish: Et kardiovaskulært sikkerhedsvurderingsstudie, hvori der indgik 4595 af de 6293 forsøgspersoner, som gennemførte hovedstudiet (N=8058) og blev fulgt til og med uge 52.
English: Treatment initiation pack in an outer carton containing 1 pack with 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging and 2 packs each containing 2 clear blisters of 28 or 4 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Danish: - Startpakning i en ydre carton, der indeholder 1 pakke med 1 gennemsigtig blisterkort med 11 x CHAMPIX 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtigt blisterkort med 28 eller 2 gennemsigtige blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning og 2 pakker, der hver indeholder 2 gennemsigtige blisterkort med 28 eller 4 gennemsigtige blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning.
English: During treatment 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
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG INDHOLDS (PAKNINGSSTØRRELSE)
English: 1.96 (1.51, 2.54), P<0.0001
Danish: 1,96 (1,51, 2,54), P<0,0001 1,5 (1,24, 2,20), P=0,0007
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets
Danish: CHAMPIX 0,5 mg filmovertrukne tabletter
English: Treatment initiation packs
Danish: KARTON TIL DELPAKNING
English: 2.99 (2.33, 3.83), P<0.0001
Danish: 2,99 (2,33, 3,83), P<0,0001 2,50 (1,90, 3,29), P<0,0001
English: 3.24 (2.56, 4.11), P<0.0001
Danish: 4,00 (3,20, 5,00), P<0,0001 3,24 (2,56, 4,11), P<0,0001
English: 1 x heat sealed card pack containing 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets and 2 x heat sealed card packs each containing 2 blister packs of 28 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets - outer and inner labelling.
Danish: 1 varmeforseglet kortpakning indeholdende 11 x 0,5 mg og 14 x 1 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 28 eller 2 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter og 2 varmeforseglede kortpakninger, hver indeholdende 2 blisterpakninger med 28 eller 4 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning.