FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended dose of CHAMPIX is 1 mg once daily.
Croatian: U bolesnika s teškim oštećenjem bubrega (procijenjeni klirens kreatinina < 30 ml/min) preporučena doza lijeka CHAMPIX je 1 mg jedanput na dan.
English: These events included in the endpoint were adjudicated by a blinded, independent committee.
Croatian: Te događaje uključene u mjeru ishoda procijenilo je neovisno povjerenstvo.
English: Patients who are not willing or able to set the target quit date within 1-2 weeks, could be offered to start treatment and then choose their own quit date within 5 weeks.
Croatian: Bolesnicima koji nisu željeli ili nisu mogli odrediti ciljni datum prestanka pušenja unutar 1-2 tjedna moglo se ponuditi da započnu liječenje i zatim odaberu datum prestanka pušenja unutar 5 tjedana.
English: CHAMPIX also significantly reduced reinforcing effects of smoking that can perpetuate smoking behaviour in patients who smoke during treatment compared with placebo.
Croatian: CHAMPIX je u usporedbi s placebom također značajno umanjio učinke koji potiču na pušenje i koji bi mogli održati pušačko ponašanje u onih bolesnika koji puše tijekom liječenja.
English: Risk Ratio # (RR; 95% CI)
Croatian: # (engl. risk ratio, RR; 95% CI)
English: CHAMPIX is not recommended in paediatric patients because its efficacy in this population was not demonstrated (see sections 4.2 and 5.1).
Croatian: Primjena lijeka CHAMPIX ne preporučuje se u pedijatrijskih bolesnika jer nije dokazana njegova djelotvornost u ovoj populaciji (vidjeti dijelove 4.2 i 5.1).
English: In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.
Croatian: U terapiji za odvikavanje od pušenja, rizik od ponovnog započinjanja pušenja veći je u razdoblju neposredno po završetku liječenja.
English: Two of the studies found no difference in risk of neuropsychiatric hospitalisations between varenicline users and nicotine patch users (Hazard Ratio [HR] 1.14; 95% Confidence Interval [CI]: 0.56-2.34 in the first study, and 0.76; 95% CI: 0.40-1.46 in the second study).
Croatian: U dva ispitivanja nije utvrđena razlika u riziku od neuropsihijatrijskih hospitalizacija između korisnika vareniklina i korisnika nikotinskog flastera (omjer hazarda [HR] 1,14; 95%-tni interval pouzdanosti [CI]: 0,56-2,34 u prvom ispitivanju i 0,76; 95% CI: 0,40-1,46 u drugom ispitivanju).
English: The effect of varenicline on craving, withdrawal and reinforcing effects of smoking were not measured during the non-treatment long-term follow-up phase.
Croatian: Učinci vareniklina na žudnju, simptome ustezanja i učinke koji potiču na pušenje nisu mjereni tijekom dugoročne faze praćenja u kojoj bolesnici nisu primali lijek.
English: The efficacy and safety of varenicline has been evaluated in smokers who had the flexibility of quitting between weeks 1 and 5 of treatment.
Croatian: Fleksibilan datum prestanka pušenja između 1. i 5. tjedna Djelotvornost i sigurnost vareniklina procijenjena je u pušača koji su imali mogućnost prestati pušiti između 1. i 5. tjedna liječenja.
English: (CYPRUS BRANCH), Τηλ: +357 22 817690
Croatian: PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH), Τηλ: +357 22 817690
English: CA* wk 21-52
Croatian: CA* tjedan 21-52
English: Non-psychiatric Cohort N=3984 Varenicline Bupropion
Croatian: Nepsihijatrijska kohorta N=3984 Vareniklin Bupropion
English: Film-coated tablet of 4 mm x 8 mm
Croatian: Filmom obložena tableta dimenzija 4 mm x 8 mm
English: Neuropsychiatric Safety Meta-analyses and Observational Studies:
Croatian: Metaanalize i opservacijska ispitivanja neuropsihijatrijske sigurnosti:
English: In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).
Croatian: U bolesnika u krajnjoj fazi bubrežne bolesti vareniklin je djelotvorno uklonjen hemodijalizom (vidjeti dio 4.2).
English: Pharmacotherapeutic group: Other nervous system drugs; Drugs used in addictive disorders, Drugs used in nicotine dependence, ATC code: N07BA03
Croatian: Farmakoterapijska skupina: ostali lijekovi koji djeluju na živčani sustav; lijekovi za liječenje poremećaja ovisnosti; lijekovi za liječenje ovisnosti o nikotinu, ATK oznaka: N07BA03
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%).
Croatian: Tijekom razdoblja praćenja do najdulje 52. tjedna, u kojem bolesnici nisu primali lijek, procijenjeni su događaji uključivali potrebu za koronarnom revaskularizacijom (2,0% naspram 0,6%), hospitalizaciju zbog angine pektoris (1,7% naspram 1,1%) i novu dijagnozu periferne vaskularne bolesti ili prijam radi zahvata povezanog s perifernom vaskularnom bolešću (1,4% naspram 0,6%).
English: A key secondary endpoint was the continuous abstinence (CA) rate for week 13 through week 52.
Croatian: Ključna sekundarna mjera ishoda bila je stopa kontinuirane apstinencije (CA) od 13. do 52. tjedna.
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).
Croatian: Primjena lijeka CHAMPIX ne preporučuje se u pedijatrijskih bolesnika jer nije dokazana njegova djelotvornost u ovoj populaciji (vidjeti dijelove 5.1 i 5.2).
English: The results showed no increase in the incidence of suicidal ideation and/or behaviour in patients treated with varenicline compared to patients treated with placebo, as shown in the table below.
Croatian: Rezultati nisu pokazivali povećanje incidencije suicidalne ideacije i/ili ponašanja u bolesnika liječenih vareniklinom u usporedbi s bolesnicima koji su primali placebo, kako je prikazano u tablici u nastavku.
English: Patients received treatment for 12 weeks, followed by a non-treatment period of 40 weeks, along with age-appropriate counseling throughout the study.
Croatian: Liječenje bolesnika je trajalo 12 tjedana nakon čega je uslijedilo razdoblje bez liječenja od 40 tjedana uz savjetovanje prikladno za dob tijekom ispitivanja.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Pfizer Europe MA EEIG
English: 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.
Croatian: Primarna KV mjera ishoda bilo je vrijeme do velikih štetnih kardiovaskularnih događaja (engl. major adverse cardiovascular events, MACE), definiranih kao smrt zbog kardiovaskularnih razloga, infarkt miokarda bez smrtnog ishoda ili moždani udar bez smrtnog ishoda koji su se javili tijekom liječenja.
English: Adverse drug reactions are based on evaluation of data from pre-marketing phase 2-3 studies and updated based on pooled data from 18 placebo-controlled pre- and post-marketing studies, including approximately 5,000 patients treated with varenicline.
Croatian: Nuspojave se temelje na ocjeni podataka iz ispitivanja faze 2-3 prije stavljanja lijeka u promet te su ažurirane na temelju objedinjenih podataka iz 18 placebom kontroliranih ispitivanja prije i nakon stavljanja lijeka u promet, uključujući približno 5000 bolesnika liječenih vareniklinom.
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).
Croatian: U bolesnika s umjerenim oštećenjem bubrega (procijenjeni klirens kreatinina ≥ 30 ml/min i ≤ 50 ml/min) izloženost vareniklinu povećala se 1,5 puta u usporedbi s ispitanicima s normalnom funkcijom bubrega (procijenjeni klirens kreatinina > 80 ml/min).
English: Composite NPS AE Endpoint of severe intensity n (%)
Croatian: Kompozitni ishod NPS štetnih događaja jakog intenziteta n (%)
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,
Croatian: - Manje često: mogu se javiti u do 1 na 100 osoba o gljivične infekcije, virusne infekcije o osjećaj panike, otežano razmišljanje, nemir, promjene raspoloženja, depresija, tjeskoba,
English: Overall, a small number of MACE occurred during treatment in the trials included in the meta-analysis (CHAMPIX 7 [0.17%]; placebo 2 [0.07%]).
Croatian: Ukupno je tijekom liječenja u sklopu ispitivanja obuhvaćenih metaanalizom nastupio mali broj MACE događaja (CHAMPIX 7 [0,17%]; placebo 2 [0,07%]).
English: 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.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim (procijenjeni klirens kreatinina > 50 ml/min i ≤ 80 ml/min) do umjerenim (procijenjeni klirens kreatinina ≥ 30 ml/min i ≤ 50 ml/min) oštećenjem bubrega.
English: The following adjudicated events occurred with a frequency ≥ 1% in either treatment group during treatment (or in the 30-day period after treatment): nonfatal myocardial infarction (1.1% vs. 0.3% for CHAMPIX and placebo, respectively), and hospitalisation for angina pectoris (0.6% vs. 1.1%).
Croatian: Sljedeći procijenjeni događaji su se u obje skupine pojavljivali s učestalošću od ≥ 1% tijekom liječenja (ili u razdoblju od 30 dana nakon liječenja): infarkt miokarda bez smrtnog ishoda (1,1% za CHAMPIX i 0,3% za placebo) te hospitalizacija zbog angine pektoris (0,6% za CHAMPIX i 1,1% za placebo).
English: Due to the absence of significant hepatic metabolism, varenicline pharmacokinetics should be unaffected in patients with hepatic impairment (see section 4.2).
Croatian: S obzirom da nema značajnog jetrenog metabolizma, farmakokinetika vareniklina trebala bi ostati neizmijenjena u bolesnika s oštećenjem jetre (vidjeti dio 4.2).
English: No cases of overdose were reported in pre-marketing clinical trials.
Croatian: U kliničkim ispitivanjima prije stavljanja lijeka u promet nisu zabilježeni slučajevi predoziranja.
English: 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%).
Croatian: Od prijavljenih neuropsihijatrijskih nuspojava nesanica je bila jedina nuspojava prijavljena u ≥ 5% ispitanika u obje skupine čija je stopa incidencije bila viša kod primjene vareniklina nego kod primjene placeba (9,5% naspram 4,7%).
English: Film-coated tablet of 5 mm x 10 mm
Croatian: Filmom obložena tableta dimenzija 5 mm x 10 mm
English: Patients treated with CHAMPIX had a superior rate of CO-confirmed abstinence during weeks 9 through 12 and from weeks 9 through 52 compared to subjects treated with placebo.
Croatian: Bolesnici liječeni lijekom CHAMPIX imali su višu stopu apstinencije potvrđene izdisajnim testom ugljikova monoksida tijekom 9. do 12. tjedna i od 9. do 52. tjedna u usporedbi s ispitanicima liječenih placebom.
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).
Croatian: Primjena vareniklina u bolesnika sa ili bez psihijatrijskog poremećaja u anamnezi nije bila povezana s povećanim rizikom od ozbiljnih neuropsihijatrijskih štetnih događaja u kompozitnom primarnom ishodu u usporedbi s placebom (vidjeti dio 5.1 Farmakodinamička svojstva - Ispitivanje u ispitanika sa ili bez psihijatrijskog poremećaja u anamnezi).
English: 42 x 1 mg film-coated tablets
Croatian: 42 x 1 mg filmom obložene tablete
English: There have been post marketing reports of increased intoxicating effects of alcohol in patients treated with varenicline.
Croatian: Postoje izvješća nakon stavljanja lijeka u promet o pojačanim učincima intoksikacije alkoholom u bolesnika koji se liječe vareniklinom.
English: Patients in this study (n=1,927) received open-label CHAMPIX 1 mg twice daily for 12 weeks.
Croatian: Bolesnici su u tom otvorenom ispitivanju (n=1927) primali CHAMPIX u dozi od 1 mg dvaput na dan tijekom 12 tjedana.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D.
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
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.
Croatian: Postotak ispitanika liječenih vareniklinom u kojih su se događaji povezani sa samoubojstvom javili tijekom razdoblja aktivnog liječenja ostao je nepromijenjen u usporedbi s razdobljem nakon liječenja; u skupini koja je primala placebo taj je postotak bio niži u razdoblju nakon liječenja.
English: EXPIRY DATE EXP: MM/YYYY
Croatian: EXP: MM/GGGG
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%).
Croatian: Najčešće prijavljene nuspojave (≥ 10%) u ispitanika koji su uzimali vareniklin bile su mučnina (27,0% naspram 10,4% kod primjene placeba), glavobolja (16,8% naspram 11,2%), neuobičajeni snovi (11,3% naspram 8,2%), nesanica (10,9% naspram 4,8%) i razdražljivost (10,9% naspram 8,2%).
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).
Croatian: U toj su skupini stope prekida liječenja zbog najčešćih nuspojava u bolesnika liječenih vareniklinom bile kako slijedi: mučnina (2,7% naspram 0,6% za placebo), glavobolja (0,6% naspram 1,0% za placebo), nesanica (1,3% naspram 1,2% za placebo) i neuobičajeni snovi (0,2% naspram 0,2% za placebo).
English: There have also been post-marketing reports of rare but severe cutaneous reactions, including StevensJohnson Syndrome and Erythema Multiforme in patients using varenicline.
Croatian: Nakon stavljanja lijeka u promet u bolesnika koji uzimaju vareniklin prijavljene su i rijetke, ali teške kožne reakcije, uključujući Stevens-Johnsonov sindrom i multiformni eritem.
English: Tell your doctor if you have any changes in symptoms during treatment with CHAMPIX.
Croatian: Obavijestite liječnika ako tijekom liječenja lijekom CHAMPIX primijetite bilo kakve promjene u simptomima.
English: CA* wk 15-24
Croatian: CA* tjedan 15-24
English: Based on varenicline characteristics and clinical experience to date, CHAMPIX has no clinically meaningful drug interactions.
Croatian: S obzirom na značajke vareniklina i dosadašnje kliničko iskustvo, CHAMPIX ne ulazi u klinički značajne interakcije s drugim lijekovima.
English: It is unknown whether varenicline is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se vareniklin u majčino mlijeko.
English: Subjects aged 18-75 years, smoking 10 or more cigarettes per day were randomised 1:1:1:1 to varenicline 1 mg BID, bupropion SR 150 mg BID, nicotine replacement therapy patch (NRT) 21 mg/day with taper or placebo for a treatment period of 12 weeks; they were then followed for another 12 weeks post-treatment.
Croatian: Ispitanici u dobi od 18 do 75 godina, koji su pušili 10 ili više cigareta na dan bili su randomizirani u omjeru 1:1:1:1 na terapiju vareniklinom 1 mg dva puta na dan, bupropionom SR 150 mg dva puta na dan, flasterom nikotinske zamjenske terapije (NRT) 21 mg/dan, s postupnim smanjenjem doze ili na uzimanje placeba za razdoblje liječenja od 12 tjedana; nakon toga su praćeni u razdoblju od još 12 tjedana nakon terapije.
English: How to take CHAMPIX
Croatian: Kako uzimati CHAMPIX
English: Some people have reported seizures while taking CHAMPIX.
Croatian: Neki bolesnici su prijavili napadaje za vrijeme liječenja lijekom CHAMPIX.
English: Bupropion vs Placebo
Croatian: Bupropion naspram placeba
English: CHAMPIX vs. placebo p < 0.0001
Croatian: CHAMPIX naspram placeba p<0,0001
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).
Croatian: 4W CQR iznosio je 47,3% za vareniklin i 14,3% za placebo, dok je udio CA od 9. do 52. tjedna bio 19,8% (vareniklin) naspram 7,4% (placebo).
English: High-Dose Varenicline Low-Dose Varenicline Placebo
Croatian: Visoka doza vareniklina Niska doza vareniklina Placebo
English: Number of Patients Treated 990 Composite NPS AE Primary Endpoint, n (%)
Croatian: Broj liječenih bolesnika Kompozitni ishod NPS štetnog događaja, n (%)
English: Pregnancy Cohort Study
Croatian: Kohortno ispitivanje trudnoće
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA Holder Logo)
Croatian: Pfizer Europe MA EEIG (logo nositelja odobrenja)
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.
Croatian: Djelotvornost vareniklina je ocijenjena u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u kojem je sudjelovalo 525 ispitanika koji su imali anamnezu velike depresije u protekle dvije godine ili su bili na stabilnoj terapiji.
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.
Croatian: Sljedeća tablica prikazuje stope kompozitnog primarnog ishoda NPS štetnih događaja po liječenoj skupini i razlike u rizicima (95% CI) naspram placeba u nepsihijatrijskoj kohorti.
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.
Croatian: Primjerice, u bolesnika koji su pokušavali prestati pušiti prijavljeno je disforično ili depresivno raspoloženje; nesanica, razdražljivost, frustracija ili ljutnja; anksioznost; poteškoće s koncentracijom; nemir; usporen srčani ritam; pojačan tek ili povećanje tjelesne težine.
English: Treatment Comparisons
Croatian: Usporedbe liječenja
English: In this study, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone.
Croatian: U tom je ispitivanju incidencija mučnine, glavobolje, povraćanja, omaglice, dispepsije i umora pri kombiniranoj terapiji bila veća nego kad je nikotinska zamjenska terapija primijenjena samostalno.
English: Oral bioavailability of varenicline is unaffected by food or time-of-day dosing.
Croatian: Na bioraspoloživost vareniklina nakon peroralne primjene ne utječu hrana ni vrijeme uzimanja lijeka.
English: Contains No Blue Box
Croatian: Ne sadrži plavi okvir
English: In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Croatian: Ispitivanja in vitro pokazuju da nije vjerojatno da bi vareniklin mogao izmijeniti farmakokinetiku lijekova koji se prvenstveno metaboliziraju putem enzima citokroma P450.
English: Blisters: Store below 30°C
Croatian: Blisteri: Čuvati na temperaturi ispod 30°C.
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
Croatian: Tijekom liječenja Ocijenjeni broj Suicidalno ponašanje i/ili ideacije Suicidalno ponašanje Suicidalne ideacije Tijekom praćenja Ocijenjeni broj Suicidalno ponašanje i/ili ideacije Suicidalno ponašanje Suicidalne ideacije NRT=flaster nikotinske zamjenske terapije
English: Minor metabolites in urine include varenicline N-carbamoylglucuronide and hydroxyvarenicline.
Croatian: Sporedni metaboliti u mokraći uključuju vareniklin N-karbamoilglukuronid i hidroksivareniklin.
English: Continuous Abstinence Rates in Subjects Treated with Champix versus Placebo CHAMPIX n=602
Croatian: Stope kontinuirane apstinencije u ispitanika koji su primali Champix u usporedbi s placebom CHAMPIX n=602
English: Read the package leaflet before use numbers 1 to 14 numbers 1 to 28 sun as symbol moon as symbol
Croatian: Prije uporabe pročitajte uputu o lijeku. brojevi od 1 do 14 brojevi od 1 do 28 simbol sunca simbol mjeseca
English: To quit gradually, please refer to package leaflet for dosing instructions.
Croatian: Za postepeno prestajanje pušenja, vidjeti uputu o lijeku za upute o doziranju.
English: NRT=Nicotine replacement therapy patch
Croatian: NRT=flaster nikotinske zamjenske terapije
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.
Croatian: Ključna analiza kardiovaskularne sigurnosti uključivala je pojavu i vrijeme pojave kompozitne mjere ishoda velikih štetnih kardiovaskularnih događaja (engl. major adverse cardiovascular events, MACE) koji su obuhvaćali smrt zbog kardiovaskularnog razloga, infarkt miokarda bez smrtnog ishoda i moždani udar bez smrtnog ishoda.
English: • Obligation to conduct post-authorisation measures Not Applicable.
Croatian: • Obveza provođenja mjera nakon davanja odobrenja
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.
Croatian: Od 15. dana do kraja liječenja morate uzeti jednu svijetloplavu CHAMPIX 1 mg filmom obloženu tabletu dvaput na dan, jednom ujutro i jednom navečer, svakoga dana otprilike u isto vrijeme.
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).
Croatian: Najčešće prijavljene nuspojave u ispitanika koji su uzimali vareniklin bile su mučnina (23,8% naspram 14,0% kod primjene placeba), glavobolja (10,7% naspram 18,6% kod primjene placeba) i povraćanje (10,7% naspram 9,3% kod primjene placeba).
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.
Croatian: 2. tjedan 8. - 14. dan Od 8. do 14. dana morate uzeti jednu svijetloplavu CHAMPIX 1 mg filmom obloženu tabletu dvaput na dan, jednom ujutro i jednom navečer, svakoga dana otprilike u isto vrijeme.
English: Nonclinical data indicate varenicline has reinforcing properties albeit with lower potency than nicotine.
Croatian: Neklinički podaci pokazuju da vareniklin ima svojstva poticanja ponašanja koje dovodi do ugode, ali su ona slabija u odnosu na nikotin.
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:
Croatian: U psihijatrijskoj kohorti postotak ispitanika sa suicidalnim ideacijama i/ili ponašanjem na temelju Columbia ljestvice ocjenjivanja ozbiljnosti suicidalnosti (C-SSRS) bio je sličan između skupina s vareniklinom i placebom tijekom liječenja i praćenja bez liječenja kako je to prikazano u sljedećoj tablici.