natgillin/translations-raw huggingface dataset:
CHAMPIX also significantly reduced reinforcing effects of smoking that can perpetuate smoking behaviour in patients who smoke during treatment compared with placebo.
Zdravilo CHAMPIX je v primerjavi s placebom tudi pomembno zmanjšal okrepitvene učinke kajenja, zaradi katerih lahko bolniki, ki med zdravljenjem kadijo, znova zapadejo v kadilsko vedenje.
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
med zdravljenjem število ocenjenih samomorilno vedenje in/ali misli samomorilno vedenje samomorilne misli med spremljanjem število ocenjenih samomorilno vedenje in/ali misli samomorilno vedenje samomorilne misli NRT nadomestno zdravljenje z nikotinskim obližem
Weeks 3 - 12 Day 15end of treatment
15. dan - do konca zdravljenja
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)).
Stopnja trajne abstinence od 9. do 12. tedna je bila 35,9 % pri skupini, ki je prejemala zdravljenje z vareniklinom, v primerjavi s 15,6 % pri skupini, ki je prejemala placebo (OR 3,35 (95 % IZ 2,16-5,21)), od 9 do 52 tedna pa 20,3 % v primerjavi z 10,4 % (OR 2,36 (95 % IZ 1,40-3,98)).
In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).
Pri preskušancih s končno odpovedjo ledvic je hemodializa učinkovito odstranila vareniklin (glejte poglavje 4.2).
The primary CV endpoint was the time to major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke during treatment.
Primarni opazovani dogodek srčnožilne varnosti je bil čas do pojava izrazitejših srčnožilnih neželenih učinkov (MACE), ki so definirani kot srčnožilna smrt, miokardni infarkt brez smrtnega izida ali možganska kap brez smrtnega izida med zdravljenjem.
12-to-17-Year Olds n/N (%)
populacija 12-17 let n/N (%)
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%).
V do 52 tednov dolgem obdobju spremljanja, med katerim bolniki zdravila niso prejemali, so bili potrjeni dogodki naslednji: potreba po koronarni revaskularizaciji (2,0 % v primerjavi z 0,6 %), hospitalizacija zaradi angine pektoris (1,7 % v primerjavi z 1,1 %) in na novo postavljena diagnoza periferne žilne bolezni ali sprejem zaradi periferne žilne bolezni (1,4 % v primerjavi z 0,6 %).
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).
Uporaba vareniklina pri bolnikih s psihiatrično motnjo v anamnezi ali brez nje ni bila povezana s povečanim tveganjem za pojav resnih nevropsihiatričnih neželenih dogodkov v sestavljenem glavnem opazovanem dogodku v primerjavi s placebom (glejte poglavje 5.1 Farmakodinamične lastnostiŠtudija pri preskušancih s psihiatrično motnjo v anamnezi ali brez nje).
* Of these, one patient in each treatment arm reported suicidal behaviour ** Patients with events up to 30 days after treatment; % are not weighted by study # RR of incidence rates per 100 patient years
** Bolniki z dogodki do 30 dni po zdravljenju; % niso uteženi na posamezno študijo.
42 x 1 mg film-coated tablets
42 x 1 mg filmsko obloženih tablet
In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Študije in vitro kažejo, da ni verjetno, da bi vareniklin spremenil farmakokinetiko spojin, ki se primarno presnovijo z encimi citokroma P450.
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)
Število bolnikov in razmerje tveganja za samomorilne misli in/ali vedenje, kot so poročali po lestvici C-SSRS v meta analizi 5 kliničnih preskušanj, kjer so primerjali vareniklin in placebo: vareniklin (n = 1.130)
154 x 1 mg film-coated tablets
154 x 1 mg filmsko obloženih tablet
Among reported neuropsychiatric adverse events, insomnia was the only event reported in either treatment group in ≥ 5% of subjects at a rate higher in the varenicline group than in placebo (9.5% vs. 4.7%).
Med poročanimi nevropsihiatričnimi neželenimi učinki je bila nespečnost edini neželeni učinek, o katerem so poročali pri ≥ 5 % preskušancev v katerikoli od obeh skupin, pri čemer je bila v skupini, ki je prejemala vareniklin, pogostejša v primerjavi s skupino, ki je prejemala placebo (9,5 % v primerjavi s 4,7 %).
Psychiatric Cohort N=4074
psihiatrična kohorta n = 4.074
Warnings and precautions Talk to your doctor or pharmacist before taking CHAMPIX.
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila CHAMPIX se posvetujte z zdravnikom ali farmacevtom.
Odds ratio (95% CI), p value
razmerje obetov (95 % IZ), vrednost p
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:
Število bolnikov in razmerje tveganja za samomorilne misli in/ali vedenje, kot so poročali po lestvici C-SSRS v meta analizi 5 kliničnih preskušanj, kjer so primerjali vareniklin in placebo:
Pregnancy Cohort Study
Kohortna študija pri nosečnicah
Rash, pruritus Erythema, acne, hyperhidrosis, night sweats
Občasni eritem, akne, hiperhidroza, nočno znojenje
Day 1 - 3
1. do 3. dan:
Varenicline pharmacokinetics were unchanged in subjects with mild renal impairment (estimated creatinine clearance > 50 ml/min and  80 ml/min).
Farmakokinetika vareniklina pri osebah z blago okvaro ledvic (ocenjeni očistek kreatinina > 50 ml/min in  80 ml/min) ni bila spremenjena.
To quit gradually, please refer to package leaflet for dosing instructions.
Za postopno prenehanje kajenja glejte navodila za odmerjanje v navodilu za uporabo.
No cases of overdose were reported in pre-marketing clinical trials.
V okviru kliničnih preskušanj pred začetkom trženja zdravila ni bilo opisanih primerov prevelikega odmerjanja.
The results showed a similar incidence of combined neuropsychiatric adverse events, other than sleep disorders, in patients treated with varenicline compared to patients treated with placebo, with a risk ratio (RR) of 1.01 (95% CI: 0.89-1.15).
Rezultati so pri bolnikih, zdravljenih z vareniklinom, in bolnikih, zdravljenih s placebom, pokazali podobno pojavnost kombiniranih nevropsihiatričnih neželenih učinkov, ki ne vključujejo motenj spanja, pri čemer je bilo razmerje tveganja (RR) 1,01 (95 % IZ: 0,89-1,15).
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).
Študija nevropsihiatrične varnosti pri preskušancih s psihiatrično motnjo v anamnezi ali brez nje Vareniklin so ovrednotili v randomizirani, dvojno slepi, z učinkovino in placebom nadzorovani študiji, ki je vključevala preskušance s psihiatrično motnjo v anamnezi (psihiatrična kohorta, n = 4.074) in preskušance brez psihiatrične motnje v anamnezi (nepsihiatrična kohorta, n = 3.984).
Varenicline exhibits linear kinetics when given as single (0.1 to 3 mg) or repeated 1 to 3 mg/day doses.
Kinetika vareniklina, uporabljenega v posamičnem odmerku (od 0,1 do 3 mg) ali ponavljajočih se odmerkih (od 1 do 3 mg/dan), je linearna.
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.
Naslednja preglednica prikazuje deleže neželenih dogodkov sestavljenega glavnega opazovanega dogodka NPS po zdravljenih skupinah in razlike v tveganjih (RD - Risk Differences) (95 % IZ) v primerjavi s placebom v nepsihiatrični kohorti.
Effect of smoking cessation
Učinek prenehanja kajenja
Contains No Blue Box
Ne vsebuje modrega okenca
Varenicline did not alter the pharmacokinetics of warfarin.
Vareniklin ni spremenil farmakokinetike varfarina.
Myocardial infarction, angina pectoris, tachycardia, palpitations, heart rate increased
Občasni miokardni infarkt, angina pektoris, tahikardija, palpitacije, višja srčna frekvenca
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.
Pri bolnikih, ki poskušajo opustiti kajenje, so bili opisani npr. disforično ali depresivno razpoloženje; nespečnost, razdražljivost, frustracija ali jeza; anksioznost, težave s koncentracijo; nemir; upočasnjen srčni utrip; večji apetit ali povečanje telesne mase.
CA* wk 9-52
CA* tedni 9-52
In smoking cessation therapy, risk of returning to smoking may be elevated in the period immediately following the end of treatment.
Pri odvajanju od kajenja s pomočjo zdravil lahko takoj po koncu zdravljenja nastopi povečano tveganje za ponoven začetek kajenja.
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.
Od 15. dne do konca zdravljenja vzemite eno svetlomodro filmsko obloženo tableto CHAMPIX 1 mg dvakrat na dan, eno zjutraj in eno zvečer, vsak dan ob približno istem času.
What CHAMPIX contains - The active substance is varenicline.
Kaj vsebuje zdravilo CHAMPIX - Učinkovina je vareniklin.
Continuous Abstinence Rates in Subjects Treated with Champix versus Placebo CHAMPIX n=602
Stopnje trajne abstinence pri preskušancih, zdravljenih z zdravilom Champix ali placebom CHAMPIX n = 602
Due to the absence of significant hepatic metabolism, varenicline pharmacokinetics should be unaffected in patients with hepatic impairment (see section 4.2).
Ker se vareniklin v jetrih ne presnavlja pomembno, farmakokinetika vareniklina pri bolnikih z okvaro jeter ne bi smela biti spremenjena (glejte poglavje 4.2).
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).
V tretji študiji med uporabniki vareniklina in uporabniki bupropiona niso poročali o razlikah v tveganju za pojav psihiatričnih neželenih učinkov, ki so jih diagnosticirali med obiskom oddelka za nujno medicinsko pomoč ali hospitalizacijo (HR 0,85; 95 % IZ: 0,55-1,30).
Prothrombin time (INR) was not affected by varenicline.
Vareniklin ni vplival na protrombinski čas (INR).
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).
Najpogostejši neželeni učinki pri preskušancih, ki so prejemali vareniklin, so bili navzea (23,8 % v primerjavi s 14,0 % pri placebu), glavobol (10,7 % v primerjavi z 18,6 % pri placebu) in bruhanje (10,7 % v primerjavi z 9,3 % pri placebu).
Therefore, active substances that are cleared by renal secretion (e.g., metformin - see below) are unlikely to be affected by varenicline.
Zato ni verjetno, da bi vareniklin vplival na učinkovine, ki se iz telesa odstranijo z ledvično sekrecijo (npr. metformin - glejte spodaj).
Non-clinical data revealed no hazard for humans based on standard male and female fertility studies in the rat (see section 5.3).
Predklinični podatki na podlagi standardnih študij o vplivih na plodnost pri podganah moškega in ženskega spola niso razkrili nobenih nevarnosti za ljudi (glejte poglavje 5.3).
However, the use of varenicline, bupropion and NRT in the psychiatric cohort was not associated with a significantly increased risk of NPS adverse events in the composite primary endpoint compared with placebo (95% CIs included zero).
Vendar pa uporaba vareniklina, bupropiona in NRT v psihiatrični kohorti ni bila povezana s pomembno povečanim tveganjem za NPS neželene dogodke v sestavljenem glavnem opazovanem dogodku v primerjavi s placebom (95 % intervali zaupanja so vključevali nič).
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.
8. do 14. dan Od 8. do 14. dne vzemite eno svetlomodro filmsko obloženo tableto CHAMPIX 1 mg dvakrat na dan, eno zjutraj in eno zvečer, vsak dan ob približno istem času.
How to take CHAMPIX
Kako jemati zdravilo CHAMPIX
If in doubt, you should consult your doctor or pharmacist.
Če ste v dvomih, se posvetujte z zdravnikom ali farmacevtom.
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).
Uporaba vareniklina, bupropiona in NRT v nepsihiatrični kohorti ni bila povezana s pomembno povečanim tveganjem za NPS neželene dogodke v sestavljenem glavnem opazovanem dogodku v primerjavi s placebom (95 % intervali zaupanja so bili manjši od, ali so vključevali, nič).
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).
Pri bolnikih s končno odpovedjo ledvic ni zadostnih izkušenj z zdravilom CHAMPIX, zato ga v tej populaciji bolnikov ni priporočljivo uporabljati (glejte poglavje 5.2).
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).
V tej skupini so bili deleži prekinitev zdravljenja zaradi najpogostejših neželenih učinkov med bolniki, ki so dobivali vareniklin, kot sledi: navzea (2,7 % v primerjavi z 0,6 % pri placebu), glavobol (0,6 % v primerjavi z 1,0 % pri placebu), nespečnost (1,3 % v primerjavi z 1,2 % pri placebu) in nenormalne sanje (0,2 % v primerjavi z 0,2 % pri placebu).
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.
Naslednja preglednica prikazuje deleže neželenih dogodkov sestavljenega glavnega opazovanega dogodka NPS po zdravljenih skupinah in RD (95 % IZ) v primerjavi s placebom v psihiatrični kohorti.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome and Erythema Multiforme) have been reported with the use of CHAMPIX.
Pri uporabi zdravila CHAMPIX so poročali o potencialno smrtno nevarnih kožnih izpuščajih (StevensJohnsonov sindrom in multiformni eritem).
A meta-analysis of 18 double-blind, randomised, placebo-controlled clinical trials was conducted to assess the neuropsychiatric safety of varenicline.
Za oceno nevropsihiatrične varnosti vareniklina so izvedli meta analizo 18 dvojno slepih, randomiziranih, s placebom nadzorovanih kliničnih preskušanj.
Cellulose, Microcrystalline Calcium Hydrogen Phosphate Anhydrous Croscarmellose Sodium Silica, Colloidal Anhydrous Magnesium Stearate
Jedro tablet mikrokristalna celuloza brezvodni kalcijev hidrogenfosfat premreženi natrijev karmelozat brezvodni koloidni silicijev dioksid magnezijev stearat
AE, adverse event; NRT=Nicotine replacement therapy patch
AE neželeni dogodek; NRT nadomestno zdravljenje z nikotinskim obližem
There are no clinically meaningful differences in varenicline pharmacokinetics due to age, race, gender, smoking status, or use of concomitant medicinal products, as demonstrated in specific pharmacokinetic studies and in population pharmacokinetic analyses.
Kot so pokazale specifične farmakokinetične študije in analize populacijske farmakokinetike, se farmakokinetika vareniklina ne razlikuje klinično pomembno glede na starost, raso, spol, kadilski status ali sočasno uporabo drugih zdravil.
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
Občasni samomorilne misli, agresija, panična reakcija, nenormalno mišljenje, nemir, nihanje razpoloženja, depresija*, anksioznost*, halucinacije*, zvečan libido, zmanjšan libido
No dosage adjustment is necessary for patients with mild (estimated creatinine clearance > 50 ml/min and  80 ml/min) to moderate (estimated creatinine clearance  30 ml/min and  50 ml/min) renal impairment.
Bolnikom z blago (ocenjeni očistek kreatinina > 50 ml/min in  80 ml/min) do zmerno (ocenjeni očistek kreatinina  30 ml/min in  50 ml/min) okvaro ledvic odmerka ni treba prilagoditi.
Varenicline (N=5072)
vareniklin (n = 5.072)
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:
Odstotek preskušancev s samomorilnimi mislimi in/ali vedenjem glede na lestvico C-SSRS (C-SSRS Columbia Suicide Severity Rating Scale) v skupinah, ki sta prejemali vareniklin in placebo, je bil v času zdravljenja in spremljanja brez zdravljenja podoben, kot prikazuje spodnja preglednica:
The effects of stopping smoking
Učinki opustitve kajenja
History of psychiatric disorders
Psihiatrične motnje v anamnezi
In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.
Pri odvajanju od kajenja s pomočjo zdravil nastopi takoj po koncu zdravljenja povišano tveganje za ponoven začetek kajenja.
You should be aware of the possible emergence of serious neuropsychiatric symptoms, such as agitation, depressed mood, or changes in behaviour during a quit attempt with or without CHAMPIX and you should contact a doctor or pharmacist if you experience such symptoms.
Med poskusom opustitve kajenja z zdravilom CHAMPIX ali brez njega se morate zavedati možnega pojava resnih nevropsihiatričnih simptomov, kot so agitacija, depresivno razpoloženje ali spremembe v vedenju; če opazite take simptome, se nemudoma posvetujte z zdravnikom ali farmacevtom.
Hypromellose Titanium Dioxide (E171) Macrogol 400
Filmska obloga hipromeloza titanov dioksid (E171) makrogol 400 triacetin
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.
4. do 7. dan Od 4. do 7. dne vzemite eno belo filmsko obloženo tableto CHAMPIX 0,5 mg dvakrat na dan, eno zjutraj in eno zvečer, vsak dan ob približno istem času.
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.
0,5 mg filmsko obložene tablete velikosti 4 mm x 8 mm: bele, bikonveksne tablete kapsulaste oblike z oznako "Pfizer" na eni strani in "CHX 0.5" na drugi strani.
White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side.
Bele, bikonveksne tablete kapsulaste oblike z oznako "Pfizer" na eni strani in "CHX 0.5" na drugi strani.
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).
4-tedenska trajna opustitev kajenja (4W-CQR) je pri vareniklinu znašala 47,3 %, pri placebu pa 14,3 %, trajna abstinenca (CA) od 9. do 52. tedna pa je pri vareniklinu znašala 19,8 %, pri placebu pa 7,4 %.
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:
V psihiatrični kohorti je bil odstotek preskušancev s samomorilnimi mislimi in/ali vedenjem glede na lestvico C-SSRS v skupinah, ki sta prejemali vareniklin in placebo, v času zdravljenja in spremljanja brez zdravljenja podoben, kot prikazuje spodnja preglednica:
CHAMPIX 1 mg film-coated tablets are light blue film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 1.0”
- CHAMPIX 1 mg filmsko obložene tablete so svetlomodre filmsko obložene tablete zaobljene kapsulaste oblike z oznakama "Pfizer" in "CHX 1.0"
What CHAMPIX looks like and contents of the pack CHAMPIX 0.5 mg film-coated tablets are white, film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 0.5”
Izgled zdravila CHAMPIX in vsebina pakiranja - CHAMPIX 0,5 mg filmsko obložene tablete so bele filmsko obložene tablete zaobljene kapsulaste oblike z oznakama "Pfizer" in "CHX 0.5"
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.
Preskušance so randomizirali na prejemanje 1 mg zdravila CHAMPIX dvakrat na dan (n = 760) ali placeba (n = 750) za obdobje 24 tednov, nato pa so jih po koncu zdravljenja spremljali do 52. tedna.
Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upperairway cough syndrome, rhinorrhoea Laryngeal pain, snoring
Občasni vnetje zgornjih dihal, kongestija dihal, disfonija, alergijski rinitis, draženje žrela, kongestija sinusov, sindrom kašlja zgornjih dihalnih poti (pocejanje v žrelo), rinoreja
11 x 0.5 mg and 14 x 1 mg
filmsko obložene tablete 11 x 0,5 mg in 14 x 1 mg
Gastrooesophageal reflux disease, vomiting, constipation, diarrhoea, abdominal distension, abdominal pain, toothache, dyspepsia, flatulence, dry mouth
Pogosti gastroezofagealna refluksna bolezen, bruhanje, zaprtje, driska, napihnjenost trebuha, bolečina v trebuhu, zobobol, dispepsija, flatulenca, suhost ust
NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA Holder Logo)
Pfizer Europe MA EEIG (kot logotip imetnika dovoljenja za promet)
Odds ratio CHAMPIX vs. bupropion p < 0.0001
razmerje obetov CHAMPIX v primerjavi z bupropionom p < 0,0001
Dyspnoea, cough
• kratka sapa, kašelj
The effect of varenicline on craving, withdrawal and reinforcing effects of smoking were not measured during the non-treatment long-term follow-up phase.
Med fazo dolgoročnega spremljanja brez zdravil niso merili učinkov vareniklina na hlepenje, odtegnitvene učinke in okrepitvene učinke kajenja.
EXPIRY DATE EXP: MM/YYYY
Uporabno do: MM/LLLL
4-week treatment initiation pack containing: 11 x 0.5 mg film-coated tablets and
Štiritedensko pakiranje za začetek zdravljenja, ki vsebuje: 11 x 0,5 mg filmsko obloženih tablet in
PHARMACEUTICAL FORM AND CONTENTS 56 Film-coated tablets
Pakiranje za vzdrževalno zdravljenje, ki vsebuje 56 filmsko obloženih tablet
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.
Preskušanci so 12 tednov prejemali zdravilo CHAMPIX 1 mg dvakrat na dan (n = 353) ali placebo (n = 350), zdravljenju pa je sledilo 40 tednov dolgo obdobje spremljanja.
Odds ratio (95% CI)
razmerje obetov (95 % IZ)
Subjects treated with CHAMPIX had a significantly higher Continuous Abstinence Rate compared with placebo; the key results are summarised in the following table:
Preskušanci, zdravljeni z zdravilom CHAMPIX, so imeli pomembno večjo stopnjo trajne abstinence v primerjavi s tistimi, ki so prejemali placebo.