natgillin/translations-raw huggingface dataset:
Virkning og sikkerhed af Champix hos patienter med alvorlige psykiatriske lidelser, f. eks. skizofreni, bipolar lidelse og alvorlig depression, er ikke blevet fastslået.
3 The safety and efficacy of Champix in patients with serious psychiatric illness such as schizophrenia, bipolar disorder and major depressive disorder has not been established.
Der bør udvises forsigtighed ved behandling af patienter med psykiatriske lidelser i anamnesen og patienterne skal rådgives herefter.
Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly.
3 Der er ingen klinisk erfaring med behandling af patienter med epilepsi med CHAMPIX.
There is no clinical experience with CHAMPIX in patients with epilepsy.
Efter endt behandling medførte afbrydelsen af behandling med CHAMPIX, at op til 3% af patienterne oplevede øget irritabilitet, rygetrang, depression og/ eller søvnløshed.
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.
Lægen bør informere patienten om dette og overveje nødvendigheden af aftrapning.
The prescriber should inform the patient accordingly and discuss or consider the need for dose tapering.
In vitro- forsøg tyder på, at der er usandsynligt, at vareniclin ændrer farmakokinetikken for stoffer, der primært metaboliseres af cytochrom P450- enzymer.
In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Dosisjustering af CHAMPIX er derfor ikke nødvendig.
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.
In vitro- forsøg viser, at vareniclin ikke hæmmer human renal transport- proteiner ved terapeutiske koncentrationer.
In vitro studies demonstrate that varenicline does not inhibit human renal transport proteins at therapeutic concentrations.
Det er derfor usandsynligt, at aktive stoffer, der elimineres ved renal udskillelse (f. eks. metformin – se nedenfor) påvirkes af vareniclin.
Therefore, active substances that are cleared by renal secretion (e. g. metformin - see below) are unlikely to be affected by varenicline.
4. 4).
Smoking cessation itself may result in changes to warfarin pharmacokinetics (see section 4.4).
Der foreligger kun begrænsede kliniske data for den potentielle interaktion mellem alkohol og vareniclin.
There is limited clinical data on any potential interaction between alcohol and varenicline.
Anvendelse sammen med andre midler til rygeophør:
Use with other therapies for smoking cessation:
Nicotinsubstitution:
Nicotine replacement therapy (NRT):
Når vareniclin og transdermal nicotinsubstitution blev anvendt samtidigt hos rygere i 12 dage, var der et statistisk signifikant fald i det gennemsnitlige systoliske blodtryk (gennemsnitligt 2, 6 mmHg) målt på den sidste dag i undersøgelsen.
When varenicline and transdermal NRT were co-administered to smokers for 12 days, there was a statistically significant decrease in average systolic blood pressure (mean 2.6 mmHg) measured on the final day of the study.
I dette kliniske forsøg var incidencen af kvalme, hovedpine, opkastning, svimmelhed, dyspepsi og træthed større i kombinationsgruppen end hos gruppen der kun fik nicotinsubstitution.
In this study, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone.
Der foreligger ikke tilstrækkelige data om brugen af vareniclintartrat hos gravide kvinder.
There are no adequate data from the use of CHAMPIX in pregnant women.
CHAMPIX bør ikke anvendes under graviditet.
CHAMPIX should not be used during pregnancy.
Når der træffes beslutning om, hvorvidt amning skal fortsættes/ standses, eller hvorvidt behandling med CHAMPIX skal fortsættes/ standses, skal der tages højde for fordele for barnet ved amning i henhold tilfordele for CHAMPIX- behandlingen af kvinden.
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.
Der er i CHAMPIX- undersøgelserne ikke anvendt design eller analyser for at skelne mellem bivirkninger, der var forbundet med den anvendte forsøgsmedicin og bivirkninger, der var forbundet med nicotinophør.
No attempt has been made in either the design or the analysis of the CHAMPIX studies to distinguish between adverse events associated with study drug treatment or those possibly associated with nicotine withdrawal.
Kliniske forsøg omfatter omkring 4. 000 patienter, der blev behandlet med CHAMPIX i op til 1 år (gennemsnitligt 84 dage).
Clinical trials included approximately 4,000 patients treated with CHAMPIX for up to 1 year (average exposure 84 days).
Graden af disse bivirkninger var typisk mild til moderat, og der var ingen forskelle mellem alder, race eller køn med hensyn til incidens af bivirkningerne.
In general, when adverse reactions occurred, onset was in the first week of therapy; severity was generally mild to moderate and there were no differences by age, race or gender with regard to the incidence of adverse reactions.
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%).
In patients treated with the recommended dose of 1mg BID following an initial titration period the adverse event most commonly reported was nausea (28.6%).
Kvalmen resulterede sjældent i seponering af behandling.
In the majority of cases nausea occurred early in the treatment period, was mild to moderate in severity and seldom resulted in discontinuation.
Seponeringsraten på grund af bivirkninger er 11, 4% for vareniclin sammenlignet med 9, 7% for placebo.
The treatment discontinuation rate due to adverse events was 11.4% for varenicline compared with 9.7% for placebo.
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 drømmeforstyrrelser (0, 2% versus 0, 2% for placebo).
0.2% for placebo).
Inden for hver frekvensgruppe er de alvorligste bivirkninger anført først.
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)). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Bivirkninger
Adverse Drug Reactions
Infektiøse og parasitære sygdomme Usædvanlig
Infections and Infestations Uncommon
Bronkitis, nasopharyngitis, sinuitis, svampeinfektion, virusinfektion
Bronchitis, nasopharyngitis, sinusitis, fungal infection, viral infection,.
Stofskiftesygdomme og ernæringsbetingede sygdomme Almindelig Usædvanlig Psykiske lidelser
Metabolism and nutrition disorders Common Uncommon
Øget appetit Anorexi, nedsat appetit, polydipsi
Increased appetite Anorexia, decreased appetite, polydipsia
Systemorganklasser Meget almindelig Usædvanlig
Psychiatric disorders Very common Uncommon
Bivirkninger Drømmeforstyrrelser, søvnløshed Panik- anfald, bradyfreni, abnorm tankegang, humørsvingninger
Abnormal dreams, insomnia Panic reaction, bradyphrenia, thinking abnormal, mood swings
Sygdomme i nervesystemet Meget almindelig Almindelig usædvanlig Hjertesygdomme
Nervous system disorders Very common Common Uncommon Cardiac disorders
Hovedpine Søvnighed, svimmelhed, dysgeusi Tremor, koordinationsforstyrrelser, dysartri, hypertoni, rastløshed, dysfori, hypæsthesi, hypogeusi, letargi, øget libido, nedsat libido
Headache Somnolence, dizziness, dysgeusia Tremor, coordination abnormal, dysarthria, hypertonia, restlessness, dysphoria, hypoaesthesia, hypogeusia, lethargy, libido increased, libido decreased
Usædvanlig Øjensygdomme
Uncommon Eye disorders
Atrieflimren, palpitationer
Atrial fibrillation, palpitations
Skotom, misfarvning af sclera, øjensmerter, mydriasis, fotofobi, myopi, øget tåresekretion
Scotoma, scleral discolouration, eye pain, mydriasis, photophobia, myopia, lacrimation increased
Sygdomme i det ydre og det indre øre Usædvanlig
Ear and labyrinth disorders Uncommon
Sygdomme i åndedrætsorganer, brysthule og mediastinum Usædvanlig
Respiratory, thoracic and mediastinal disorders Uncommon
Dyspnø, hoste, hæshed, smerter i svælget, halsirritation, tilstopning af luftveje, tilstoppede bihuler, post nasal drip, næseflåd, snorken
Dyspnoea, cough, hoarseness, pharyngolaryngeal pain, throat irritation, respiratory tract congestion, sinus congestion, post nasal drip, rhinorrhoea, snoring
Gastrointestinale sygdomme Meget almindelig Almindelig
Gastrointestinal disorders Very common Common
Kvalme Opkastning, forstoppelse, diarré, udspilet abdomen, maveubehag, dyspepsi, flatulens, mundtørhed
Nausea Vomiting, constipation, diarrhoea, abdominal distension, stomach discomfort, dyspepsia, flatulence, dry mouth
Hæmatemese, hæmatokezi, gastritis, gastroesofageal reflukssygdom, mavesmerter, ændring i tarmmotilitet, unormal afføring, sure opstød, aphthæ stomatitis, smerter i gummerne, tungebelægninger
Haematemesis, haematochezia, gastritis, gastrooesophageal reflux disease, abdominal pain, change of bowel habit, abnormal faeces, eructation, aphthous stomatitis, gingival pain, tongue coated
Sygdomme i hud og subkutane væv Usædvanlig
Skin and subcutaneous tissue disorders Uncommon
Generaliseret udslæt, erytem, pruritus, akne, hyperhidrose, nattesved
Rash generalised, erythema, pruritus, acne, hyperhidrosis, night sweats
Sygdomme i bevægeapparatet og bindevæv Usædvanlig
Uncommon
Ledstivhed, muskelspasmer, smerter i brystvæggen, costochondritis
Joint stiffness, muscle spasms, chest wall pain, costochondritis
Sygdomme i nyre og urinveje Usædvanlig
Renal and urinary disorders Uncommon
Glykosuri, nykturi, polyuri
Glycosuria, nocturia, polyuria
Lidelser i det reproduktive system og brystsygdomme Usædvanlig
Reproductive system and breast disorders Uncommon
Menorrhagi, udflåd, seksuel dysfunktion
Menorrhagia, vaginal discharge, sexual dysfunction
Almene lidelser og reaktioner på indgivelsesstedet Almindelig Usædvanlig Undersøgelser
General disorders and administration site conditions Common Uncommon Investigations
Træthed Ubehag i brystet, brystsmerter, pyreksi, kuldefølelse, asteni, circadisk søvn- rytmeforstyrrelse, utilpashed, cyster
Fatigue Chest discomfort, chest pain, pyrexia, feeling cold, asthenia, circadian rhythm sleep disorder, malaise, cyst
Forhøjet blodtryk, nedsat ST- segment og T- bølge amplitude ved elektrodiagram, forøget hjertefrekvens, abnorm levertest, nedsat antal blodplader, vægtøgning, unormal sædkvalitet, øgning af C - reaktivt protein, nedsat calcium i blodet
Blood pressure increased, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased, heart rate increased, liver function test abnormal, platelet count decreased, weight increased, semen abnormal, C-reactive protein increased, blood calcium decreased
4. 4).
Post-marketing cases of myocardial infarction, depression and suicidal ideation have been reported in patients taking varenicline (see section 4.4).
Der er også rapporteret om overfølsomhedsreaktioner, f. eks. angioødem og hævelse i ansigtet.
There have also been reports of hypersensitivity reactions, such as angioedema and facial swelling.
Der er ikke indberettet tilfælde af overdosering i kliniske forsøg før markedsføring.
No cases of overdose were reported in pre-marketing clinical trials.
I tilfælde af overdosering anbefales understøttende behandling efter behov.
6 In case of overdose, standard supportive measures should be instituted as required.
Der er dog ingen erfaring med dialyse efter overdosering.
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.
Farmakoterapeutisk klassifikation: rygeophør, ATC- kode:
Active substances used in nicotine dependence, ATC code:
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.
Varenicline binds with high affinity and selectivity at the α 4β 2 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.
Dette sker dogved et signifikant lavere niveau end hos nicotin.
Electrophysiology studies in vitro and neurochemical studies in vivo have shown that varenicline binds to the α 4β 2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a significantly lower level than nicotine.
Nicotin konkurrerer om det samme humane α4β2 nAChR bindingssted, for hvilket vareniclin har højere affinitet.
Nicotine competes for the same human α 4β 2 nAChR binding site for which varenicline has higher affinity.
Dette er den neuronale mekanisme, der ligger til grund for forstærkning og belønningsoplevelse ved rygning.
Therefore, varenicline can effectively block nicotine's ability to fully activate α 4β 2 receptors and the mesolimbic dopamine system, the neuronal mechanism underlying reinforcement and reward experienced upon smoking.
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:
Varenicline is highly selective and binds more potently to the α 4β 2 receptor subtype (Ki=0.15 nM) than to other common nicotinic receptors (α 3β 4 Ki=84 nM, α 7 Ki= 620 nM, α 1βγδ Ki= 3,400 nM), or to non-nicotinic receptors and transporters (Ki > 1µM, except to 5-HT3 receptors:
Ved at hindre nicotin i at virke på α4β2- receptorerne (antagonist virkning) nedsætter det samtidig belønningsoplevelsen og rygningens selvforstærkende mekanisme.
The efficacy of CHAMPIX in smoking cessation is a result of varenicline's partial agonist activity at the α 4β 2 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 α 4β 2 receptors (antagonist activity).
Effekten af CHAMPIX til rygeophør er vist i 3 kliniske forsøg med kroniske cigaretrygere (≥10 cigaretter per dag).
The efficacy of CHAMPIX in smoking cessation was demonstrated in 3 clinical trials involving chronic cigarette smokers (≥ 10 cigarettes per day).
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.
2619 patients received CHAMPIX 1mg BID (titrated during the first week), 669 patients received bupropion 150 mg BID (also titrated) and 684 patients received placebo.
Sammenlignende kliniske forsøg
Comparative Clinical Studies
2 identiske, dobbeltblindede kliniske forsøg sammenlignede virkningen af CHAMPIX (1 mg 2 gange dagligt), depotformuleret bupropion (150 mg 2 gange dagligt) og placebo ved rygeophør.
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.
I disse forsøg, der forløb over 52 uger, fik patienterne behandling i 12 uger efterfulgt af 40 uger uden behandling.
In these 52-week duration studies, patients received treatment for 12 weeks, followed by a 40-week non- treatment phase.
Det primære endepunkt for de 2 forsøg, 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).
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.
Efter 40 uger uden behandling er det vigtigste sekundære endepunkt for begge kliniske forsøg den vedvarende afholdenhedsrate (Continuous Abstinence Rate, CA) ved uge 52.
After the 40 week non-treatment phase, a key secondary endpoint for both studies was the Continuous Abstinence Rate (CA) at week 52.
4W- CQR (uge 9 til og med uge 12) og CA rater (uge 9 til og med uge 52) fra forsøgene 1 og 2 fremgår af nedenstående tabel:
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:
Forsøg 1 (n=1022)
Study 1 (n=1022)
Forsøg 2 (n=1023)
Study 2 (n=1023)
CHAMPIX Bupropion Placebo Odds ratio
CHAMPIX Bupropion Placebo Odds ratio
4W CQR 44, 4% 29, 5% 17, 7% 3, 91
4W CQR 44.4% 29.5% 17.7% 3.91
Uge 9- 52 4W CQR 22, 1% 44, 0% 16, 4% 30, 0% 8, 4% 17, 7% 3, 13 3, 85
Wk 9-52 4W CQR 22.1% 44.0% 16.4% 30.0% 8.4% 17.7% 3.13 3.85
Uge 9- 52 23, 0% 15, 0% 10, 3% 2, 66
Wk 9-52 23.0% 15.0% 10.3% 2.66
CHAMPIX vs. placebo Odds ratio CHAMPIX vs. bupropion
CHAMPIX vs placebo Odds ratio CHAMPIX vs bupropion
P < 0, 0001 1, 96 p < 0, 0001
p < 0.0001 1.96 p < 0.0001
p < 0, 0001 1, 45 p=0, 0640
p < 0.0001 p < 0.0001 1.45 1.89 p=0.0640 p < 0.0001
p < 0, 0001 1, 72 p=0, 0062
p < 0.0001 1.72 p=0.0062
Patienter, der rapporterer om rygetrang, rygeophør og forstærkende virkning af rygning I den aktive behandlingsperiode i både forsøg 1 og 2 var rygetrang og rygeophør signifikant nedsat hos patienter randomiseret til CHAMPIX sammenlignet med placebo.
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 randomized to CHAMPIX in comparison with placebo.
Det tredje forsøg vurderer den gavnlige virkning af yderligere 12 ugers behandling med CHAMPIX for at fastholde rygeophør.
Maintenance of Abstinence Study The third study assessed the benefit of an additional 12 weeks of CHAMPIX therapy on the maintenance of abstinence.
Patienterne i dette forsøg (n=1. 927) modtog CHAMPIX open- label 1 mg 2 gange dagligt i 12 uger.
Patients in this study (n=1,927) received open-label CHAMPIX 1 mg twice daily for 12 weeks.
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 forsøgsperiode på 52 uger.
Patients who stopped smoking by Week 12 were then randomized to receive either CHAMPIX (1 mg twice daily) or placebo for an additional 12 weeks for a total study duration of 52 weeks.
Det primære endepunkt var en CO- bekræftet afholdenhedsrate (CA) fra uge 13 til og med uge 24 i den dobbelt- blindede behandlingsperiode.
The primary study endpoint was the CO-confirmed continuous abstinence rate from week 13 through week 24 in the double-blind treatment phase.
Dette forsøg viste den gavnlige virkning af yderligere 12 ugers behandling med CHAMPIX 1 mg 2 gange dagligt for at fastholde rygeophør sammenlignet med placebo.
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.
Chancerne for at fastholde rygeophør efter uge 24 efter yderligere 12 ugers behandling med CHAMPIX var 2, 47 gange chancerne for placebo (p < 0, 0001).
The odds of maintaining abstinence at week 24, following an additional 12 weeks of treatment with CHAMPIX, were 2.47 times those for placebo (p < 0.0001).
Overlegenhed i forhold til placebo for CA var fastholdt til og med uge 52 (odds ratio=1, 35, p=0, 0126).
Superiority to placebo for CA was maintained through week 52 (Odds Ratio=1.35, p=0.0126).
De vigtigste resultater er opsummeret i den følgende tabel:
The key results are summarised in the following table:
Placebo n=604
Placebo n=604
Difference (95% CI)
Difference (95% CI)
Odds ratio (95% CI)
Odds ratio (95% CI)
CA uge 13- 24
CA wk 13-24
(15, 4%, 26. 2%)
(15.4%, 26.2%)
CA uge 13- 52
CA wk 13-52
På nuværende tidspunkt er den kliniske erfaring med anvendelse af CHAMPIX til sorte ikke tilstrækkelig til, at klinisk effekt kan afgøres.
There is currently limited clinical experience with the use of CHAMPIX among black people to determine clincial efficacy.
Efter oral administration af vareniclin opnås der typisk maksimal plasmakoncentration efter 3- 4 timer.
Maximum plasma concentrations of varenicline occur typically within 3-4 hours after oral administration.
Efter administration af flere orale doser hos frivillige, raske forsøgspersoner blev steady state opnået inden for 4 dage.
Following administration of multiple oral doses to healthy volunteers, steady- state conditions were reached within 4 days.
Absorptionen er stort set total efter oral administration, og den
Absorption is virtually complete after oral administration
8 systemiske tilgængelighed er høj.
8 and systemic availability is high.
Vareniclins orale biotilgængelighed af vareniclin bliver hverken påvirket af fødeindtag eller tidspunkt for dosering.
Oral bioavailability of varenicline is unaffected by food or time-of- day dosing.
Det tilsyneladende fordelingsvolumen er gennemsnitligt 415 liter (% CV=50) ved steady state.
Apparent volume of distribution averaged 415 litres (%CV= 50) at steady-state.
Vareniclins plasmaproteinbinding er lav (≤20%), og den er uafhængig af både alder og nyrefunktion.
Plasma protein binding of varenicline is low (< 20%) and independent of both age and renal function.
Mindre betydningsfulde metabolitter i urinen omfatter vareniclin- N- carbamoylglucuronid og hydroxyvareniclin.
Minor metabolites in urine include varenicline N- carbamoylglucuronide and hydroxyvarenicline.
I kredsløbet udgør vareniclin 91% af al lægemiddelrelateret materiale.
In circulation, varenicline comprises 91% of drug- related material.
Mindre betydningsfulde metabolitter i kredsløbet omfatter vareniclin - N- carbamoylglucuronid og N- glucosylvareniclin.
Minor circulating metabolites include varenicline N-carbamoylglucuronide and N- glucosylvarenicline.
Renal elimination af vareniclin sker fortrinsvis ved glomerulær filtration samt ved aktiv tubulær sekretion via organiske kationtransporter, OCT2 (se pkt.
Renal elimination of varenicline is primarily through glomerular filtration along with active tubular secretion via the organic cationic transporter, OCT2.
4. 5).
(see section 4.5).
Lineraritet/ non- linearitet:
Linearity/ Non linearity:
Vareniclin udviser lineær kinetik, når det gives som enkeltdoser (0, 1 mg til 3 mg) eller som gentagne doser (1 mg til 3 mg per dag).
Varenicline exhibits linear kinetics when given as single (0.1 to 3 mg) or repeated 1 to 3 mg/ day) doses.
Farmakokinetik i særlige patientpopulationer:
Pharmacokinetics in special patient populations:
Dette er vist i specifikke farmakokinetiske forsøg og i farmakokinetiske populationsanalyser.
There are no clinically meaningful differences in varenicline pharmacokinetics due to age, race, gender, smoking status, or use of concomitant medications, as demonstrated in specific pharmacokinetic studies and in population pharmacokinetic analyses.
På grund af fraværet af signifikant hepatisk metabolisme er vareniclins farmakokinetik upåvirket hos patienter med nedsat leverfunktion (se pkt.
Due to the absence of significant hepatic metabolism, varenicline pharmacokinetics should be unaffected in patients with hepatic impairment.
4. 2).
(see section 4.2).
Nyreinsufficiens:
Renal Insufficiency:
Vareniclins farmakokinetik er uændret hos patienter med mildt nedsat nyrefunktion (anslået kreatininclearance > 50 ml/ min og ≤80 ml/ min).
Varenicline pharmacokinetics were unchanged in subjects with mild renal impairment (estimated creatinine clearance > 50 ml/ min and ≤ 80 ml/ min).