FrancophonIA/ELRC3.0 huggingface dataset:
English: reported categories of adverse events related to psychiatric safety other than sleep disorders and disturbances.
Croatian: Tablica u nastavku pokazuje najčešće (≥ 1%) prijavljene kategorije štetnih događaja povezanih s psihijatrijskom sigurnošću osim poremećaja i smetnja sna.
English: Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour, depression, suicidal ideation and behaviour and suicide attempts have been reported in patients attempting to quit smoking with CHAMPIX in the post-marketing experience.
Croatian: Nakon stavljanja lijeka u promet u bolesnika koji su pokušali prestati pušiti uz pomoć lijeka CHAMPIX prijavljene su promjene ponašanja ili razmišljanja, anksioznost, psihoza, promjene raspoloženja, agresivno ponašanje, depresija, suicidalne ideacije i ponašanje te pokušaji samoubojstva.
English: - Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
Croatian: - Jedna filmom obložena tableta od 1 mg sadrži 1 mg vareniklina (u obliku vareniklintartarata).
English: numbers 1 to 14 numbers 1 to 28 sun as symbol moon as symbol
Croatian: 1. tjedan 2.-4. tjedan brojevi od 1 do 28 simbol sunca simbol mjeseca
English: Therefore, active substances that are cleared by renal secretion (e.g., metformin - see below) are unlikely to be affected by varenicline.
Croatian: Stoga nije vjerojatno da bi vareniklin mogao utjecati na djelatne tvari čiji se klirens provodi bubrežnom sekrecijom (npr. metformin - vidjeti u nastavku).
English: In these 52 week duration studies, patients received treatment for 12 weeks, followed by a 40 week non-treatment phase.
Croatian: U tim ispitivanjima u trajanju od 52 tjedna bolesnici su liječeni 12 tjedana, nakon čega je uslijedila faza od 40 tjedana bez terapije.
English: Tablet Core - CHAMPIX 0.5 mg and 1 mg film-coated tablets Cellulose, Microcrystalline
Croatian: Jezgra tablete - CHAMPIX 0,5 mg i 1 mg filmom obložene tablete mikrokristalična celuloza bezvodni kalcijev hidrogenfosfat umrežena karmelozanatrij bezvodni, koloidni silicijev dioksid magnezijev stearat
English: Bupropion Varenicline did not alter the steady-state pharmacokinetics of bupropion.
Croatian: Bupropion Vareniklin nije izmijenio farmakokinetiku bupropiona u stanju dinamičke ravnoteže.
English: In this 52-week duration study, patients received treatment for 12 weeks, followed by a 40-week non-treatment follow-up phase.
Croatian: U tom ispitivanju u trajanju od 52 tjedna bolesnici su liječeni 12 tjedana, nakon čega je uslijedila faza praćenja od 40 tjedana bez terapije.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg or 1 mg varenicline (as tartrate).
Croatian: Jedna tableta sadrži 0,5 mg ili 1 mg vareniklina (u obliku vareniklintartarata).
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
Croatian: Poremećaji metabolizma i prehrane često povećanje tjelesne težine, smanjeni tek, pojačan tek manje često hiperglikemija rijetko šećerna bolest, polidipsija Psihijatrijski poremećaji vrlo često neuobičajeni snovi, nesanica manje često suicidalna ideacija, agresija, panična reakcija, neuobičajeno razmišljanje, nemir, promjene raspoloženja, depresija*, anksioznost*, halucinacije*, povećan libido, smanjen libido rijetko psihoza, somnambulizam, neuobičajeno ponašanje, disforija, bradifrenija Poremećaji živčanog sustava vrlo često glavobolja često somnolencija, omaglica, disgeuzija manje često napadaj, tremor, letargija, hipoestezija rijetko nepoznato cerebrovaskularni incident, hipertonija, dizartrija, poremećaj koordinacije, hipogeuzija, poremećaj cirkadijalnog ritma spavanja prolazni gubitak svijesti
English: Odds ratio CHAMPIX vs. bupropion p < 0.0001
Croatian: Omjer izgleda CHAMPIX naspram bupropiona p<0,0001
English: 1.52 (1.23, 1.89), P=0.0001
Croatian: 1,52 (1,23; 1,89), P=0,0001 1.51 (1,19; 1,93), P=0,0008
English: Fungal infection, viral infection Blood and lymphatic system disorders Rare
Croatian: Organski sustav Nuspojava Infekcije i infestacije vrlo često nazofaringitis često bronhitis, sinusitis manje često gljivična infekcija, virusna infekcija Poremećaji krvi i limfnog sustava rijetko smanjen broj trombocita
English: Odds ratio (95% CI)
Croatian: Omjer izgleda (95% CI)
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.
Croatian: - Pakiranje za početak liječenja u vanjskoj kutiji koje sadrži 1 pakiranje s 1 prozirnim blisterom s 11 filmom obloženih tableta CHAMPIX 0,5 mg i 14 x 1 mg filmom obloženih tableta i 1 prozirnim blisterom s 28 filmom obloženih tableta CHAMPIX 1 mg ili 2 prozirna blistera s 14 filmom obloženih tableta CHAMPIX 1 mg u kartonskom ovitku i 2 pakiranja od kojih svako sadrži 2 prozirna blistera s 28 filmom obloženih tableta CHAMPIX 1 mg ili 4 prozirna blistera s 14 filmom obloženih tableta CHAMPIX 1 mg u kartonskom ovitku.
English: Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
Croatian: Jedna filmom obložena tableta sadrži 1 mg vareniklina (u obliku vareniklintartarata).
English: 1.74 (1.41, 2.14), P<0.0001
Croatian: 1,77 (1,46; 2,14), P<0,0001 1,74 (1,41 2,14), P<0,0001
English: Treatment initiation packs
Croatian: Pakiranja za početak liječenja
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 0.5 mg and 28 x 0.5 mg varenicline film-coated tablets, heat sealed card
Croatian: Blister s 14 filmom obloženih tableta od 0,5 mg vareniklina i 28 filmom obloženih tableta od 0,5 mg vareniklina, toplinski zalijepljen kartonski ovitak
English: Uncommon Rare
Croatian: Nije primjenjivo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets
Croatian: CHAMPIX 0,5 mg filmom obložene tablete CHAMPIX 1 mg filmom obložene tablete
English: 1.41 (1.11, 1.79), P=0.0047
Croatian: 1,49 (1,20; 1,85), P=0,0003 1.41 (1,11; 1,79), P=0,0047
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.
Croatian: - Pakiranja za nastavak liječenja (održavanje) koja sadrže 2 ili 4 prozirna blistera s 14 CHAMPIX 0,5 mg filmom obloženih tableta ili 2 prozirna blistera s 28 CHAMPIX 0,5 mg filmom obloženih tableta u kartonskom ovitku.
English: Varenicline N=1026 n (%)
Croatian: N=1026 n (%)
English: Numbers 1 to 14 sun as symbol moon as symbol
Croatian: 1. tjedan 2. tjedan brojevi od 1 do 14 simbol sunca simbol mjeseca
English: Heat sealed card pack containing either 2 or 4 blister packs of 14 x 0.5 mg varenicline film-coated tablets or 2 blister packs of 28 x 0.5 mg varenicline film-coated tablets- inner and outer labelling
Croatian: Toplinski zalijepljen kartonski ovitak koji sadrži ili 2 ili 4 blistera s 14 filmom obloženih tableta od 0,5 mg vareniklina ili 2 blistera s 28 filmom obloženih tableta od 0,5 mg vareniklina - unutarnje i vanjsko označivanje
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg
Croatian: CHAMPIX 0,5 mg
English: Sealed white HDPE bottle pack, with a child resistant screw cap, in a carton, containing 56 x CHAMPIX 0.5 mg film-coated tablets.
Croatian: - Bijela zatvorena bočica od polietilena visoke gustoće sa navojnim sigurnosnim zatvaračem za djecu koja sadrži 56 CHAMPIX 0,5 mg filmom obloženih tableta, u kutiji.
English: PCTFE/PVC blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in one secondary heat sealed card pack and PCTFE/PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 x 1 mg film-coated tablets.
Croatian: PCTFE/PVC blistere s aluminijskom folijom koji sadrže jedan prozirni blister s 11 x 0,5 mg filmom obloženih tableta i 14 x 1 mg filmom obloženih tableta te 1 prozirni blister s 28 x 1 mg filmom obloženih tableta ili 2 prozirna blistera s 14 x 1 mg filmom obloženih tableta u jednom sekundarnom, toplinski zalijepljenom kartonskom ovitku i PCTFE/PVC blistere s aluminijskom folijom u dva sekundarna, toplinski zalijepljena kartonska ovitka od kojih svaki sadrži 56 x 1 mg filmom obloženih tableta.
English: Varenicline N=990 n (%)
Croatian: N=990 n (%)
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.
Croatian: 1 toplinski zalijepljen kartonski ovitak koji sadrži 11 filmom obloženih tableta od 0,5 mg vareniklina i 14 filmom obloženih tableta od 1 mg vareniklina i 1 blister s 28 filmom obloženih tableta od 1 mg vareniklina ili 2 blistera s 14 filmom obloženih tableta od 1 mg vareniklina i 2 toplinski zalijepljena kartonska ovitka od kojih svaki sadrži 2 blistera s 28 filmom obloženih tableta od 1 mg vareniklina ili 4 blistera s 14 filmom obloženih tableta od 1 mg vareniklina - vanjsko i unutarnje označivanje.
English: 3.24 (2.56, 4.11), P<0.0001
Croatian: 4,00 (3,20; 5,00), P<0,0001 3,24 (2,56 4,11), P<0,0001
English: The primary endpoint of the two studies was the carbon monoxide (CO) confirmed, 4-week continuous quit rate (4W-CQR) from week 9 through week 12.
Croatian: 4-week continuous quit rate, 4W-CQR), od 9. do 12. tjedna, potvrđena izdisajnim testom ugljikova monoksida (CO).
English: 1.65 (1.24, 2.20), P=0.0007
Croatian: 1,96 (1,51; 2,54), P<0,0001 1.65 (1.24; 2,20), P=0,0007
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets
Croatian: CHAMPIX 0,5 mg filmom obložene tablete
English: HDPE Bottle: This medicinal product does not require any special storage conditions 6.5 Nature and contents of container
Croatian: HDPE bočica: Lijek ne zahtijeva posebne uvjete čuvanja.
English: Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Croatian: - Pakiranje za početak liječenja koje sadrži 2 blistera; 1 proziran blister s 11 filmom obloženih tableta CHAMPIX 0,5 mg i 1 proziran blister s 14 filmom obloženih tableta CHAMPIX 1 mg u kartonskom ovitku.
English: Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
Croatian: - Pakiranje za početak liječenja koje sadrži 2 blistera; 1 proziran blister s 11 CHAMPIX 0,5 mg filmom obloženih tableta i 1 proziran blister s 14 CHAMPIX 1 mg filmom obloženih tableta u kutiji.
English: Keep the package intact
Croatian: Pakiranje se ne smije razdvajati.
English: EU/1/06/360/023
Croatian: EU/1/06/360/012 EU/1/06/360/023
English: 2.30 (1.83, 2.90), P<0.0001
Croatian: 2,30 (1,83; 2,90), P<0,0001 2,00 (1,56 2,55), P<0,0001
English: Sealed white HDPE bottle pack, with a child resistant screw cap, in a carton, containing 56 x CHAMPIX 1 mg film-coated tablets.
Croatian: - Bijela zatvorena bočica od polietilena visoke gustoće sa navojnim sigurnosnim zatvaračem za djecu koja sadrži 56 CHAMPIX 1 mg filmom obloženih tableta, u kutiji.
English: Number assessed Suicidal behaviour and/or ideation Suicidal behaviour Suicidal ideation
Croatian: Postotak ispitanika sa suicidnom ideacijom i/ili ponašanjem koje se temelji na Columbia ljestvici ocjenjivanja ozbiljnosti suicidalnosti (engl.
English: PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton.
Croatian: PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 140 x 1 mg filmom obloženih tableta u kutiji.
English: PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
Croatian: PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 112 x 1 mg filmom obloženih tableta u kutiji.
English: Heat sealed card pack containing 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 - inner and outer labelling
Croatian: Toplinski zalijepljen kartonski ovitak koji sadrži 1 blister s 11 filmom obloženih tableta od 0,5 mg vareniklina i 1 blister s 14 filmom obloženih tableta od 1 mg vareniklina - unutarnje i vanjsko označivanje
English: PVC blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in one secondary heat sealed card pack and PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 x 1 mg film-coated tablets.
Croatian: PVC blistere s aluminijskom folijom koji sadrže jedan prozirni blister s 11 x 0,5 mg filmom obloženih tableta i 14 x 1 mg filmom obloženih tableta te 1 prozirni blister s 28 x 1 mg filmom obloženih tableta ili 2 prozirna blistera s 14 x 1 mg filmom obloženih tableta u jednom sekundarnom, toplinski zalijepljenom kartonskom ovitku i PVC blistere s aluminijskom folijom u dva sekundarna, toplinski zalijepljena kartonska ovitka od kojih svaki sadrži 56 x 1 mg filmom obloženih tableta.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 112 x 1 mg filmom obloženih tableta u kutiji.
English: Continuous Abstinence Rates in Subjects Treated with Champix versus Placebo
Croatian: Stope kontinuirane apstinencije u ispitanika koji su primali Champix u usporedbi s placebom CHAMPIX n=760
English: Treatment initiation pack containing 2 blisters; 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.
Croatian: - Pakiranje za početak liječenja koje sadrži 2 blistera; 1 proziran blister s 11 filmom obloženih tableta CHAMPIX 0,5 mg i 14 x 1 mg filmom obloženih tableta i 1 proziran blister s 28 filmom obloženih tableta CHAMPIX 1 mg tableta ili 2 prozirna blistera s 14 filmom obloženih tableta CHAMPIX 1 mg u kartonskom ovitku.
English: 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”
Croatian: Kako CHAMPIX izgleda i sadržaj pakiranja - CHAMPIX 0,5 mg filmom obložene tablete su bijele filmom obložene tablete u obliku kapsule,
English: 2.26 (1.80, 2.85), P<0.0001
Croatian: 2,26 (1,80; 2,85), P<0,0001 1,87 (1,46 2,39), P<0,0001
English: Varenicline did not alter the steady-state pharmacokinetics of digoxin.
Croatian: Vareniklin nije izmijenio farmakokinetiku digoksina u stanju dinamičke ravnoteže.
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
Croatian: Kutija koja sadrži 1 blister s 11 filmom obloženih tableta od 0,5 mg vareniklina i 1 blister s 14 filmom obloženih tableta od 1 mg vareniklina
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 0.5 mg varenicline film-coated tablets
Croatian: Naljepnica bočice od polietilena visoke gustoće (HDPE) koja sadrži 56 filmom obloženih tableta od 0,5 mg vareniklina
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 1 mg film-coated tablets
Croatian: CHAMPIX 1 mg filmom obložene tablete
English: PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Croatian: PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 56 x 1 mg filmom obloženih tableta u kutiji.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 140 x 1 mg filmom obloženih tableta u kutiji.
English: 2.99 (2.33, 3.83), P<0.0001
Croatian: 2,99 (2,33; 3,83), P<0,0001 2,50 (1,90; 3,29) , P<0,0001
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom, u pakiranju koje sadrži 28 x 0,5 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 28 x 1 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 56 x 1 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 56 x 1 mg filmom obloženih tableta u kutiji.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom, u pakiranju koje sadrži 56 x 0,5 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 28 x 1 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets, heat sealed card
Croatian: Blister s 11 filmom obloženih tableta od 0,5 mg vareniklina, toplinski zalijepljen kartonski ovitak
English: PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Croatian: PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 28 x 1 mg filmom obloženih tableta u kutiji.
English: Maintenance packs
Croatian: Prijavljivanje nuspojava
English: PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 56 x 1 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: Placebo N=999 n (%)
Croatian: N=999 n (%)
English: PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PVC blisteri s aluminijskom folijom, u pakiranju koje sadrži 28 x 0,5 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: Heat sealed card pack containing either 2 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets or 2 blister packs of 28 x 1 mg varenicline film-coated tablets- inner and outer labelling
Croatian: Toplinski zalijepljen kartonski ovitak koji sadrži bilo 2 ili 4 blistera s 14 filmom obloženih tableta od 1 mg vareniklina ili 2 blistera s 28 filmom obloženih tableta od 1 mg vareniklina - unutarnje i vanjsko označivanje
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom u pakiranju koje sadrži 28 x 1 mg filmom obloženih tableta u kutiji.
English: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom koji sadrže 1 prozirni blister s 11 x 0,5 mg filmom obloženih tableta i drugi prozirni blister s 14 x 1 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PVC blisteri s aluminijskom folijom, u pakiranju koje sadrži 56 x 0,5 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
English: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Croatian: PCTFE/PVC blisteri s aluminijskom folijom koji sadrže 1 prozirni blister s 11 x 0,5 mg filmom obloženih tableta i drugi prozirni blister s 14 x 1 mg filmom obloženih tableta u kutiji.
English: 18 placebo-controlled pre- and post-marketing studies, including approximately 5,000 patients treated with varenicline.
Croatian: Nuspojave se temelje na ocjeni podataka iz ispitvanja 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: CA Wk 9-52
Croatian: CA 9.-52. tjedan
English: PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Croatian: PVC blisteri s aluminijskom folijom koji sadrže 1 prozirni blister s 11 x 0,5 mg filmom obloženih tableta i drugi prozirni blister s 14 x 1 mg filmom obloženih tableta u sekundarnom, toplinski zalijepljenom kartonskom ovitku.
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.
Croatian: - Pakiranja za nastavak liječenja (održavanje) koja sadrže 2 ili 4 prozirna blistera s 14 CHAMPIX 1 mg filmom obloženih tableta ili 2 prozirna blistera s 28 CHAMPIX 1 mg filmom obloženih tableta u kartonskom ovitku.
English: 11 x 0.5 mg film-coated tablets and
Croatian: 11 filmom obloženih tableta od 0,5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 1 mg varenicline film-coated tablets
Croatian: Naljepnica bočice od polietilena visoke gustoće (HDPE) koja sadrži 56 filmom obloženih tableta od 1 mg vareniklina
English: 2.50 (1.90, 3.29), P<0.0001
Croatian: 2,99 (2,33; 3,83), P<0,0001 2,50 (1,90; 3,29), P<0,0001
English: PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Croatian: PVC blisteri s aluminijskom folijom koji sadrže 1 prozirni blister s 11 x 0,5 mg filmom obloženih tableta i drugi prozirni blister s 14 x 1 mg filmom obloženih tableta u kutiji.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg and 28 x 1 mg varenicline film-coated tablets, heat sealed card
Croatian: Blister s 14 filmom obloženih tableta od 1 mg vareniklina i 28 filmom obloženih tableta od 1 mg vareniklina, toplinski zalijepljen kartonski ovitak