FrancophonIA/ELRC3.0 huggingface dataset:
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
Slovenian: Toplotno zavarjeno pakiranje, ki vsebuje bodisi 2 ali 4 pretisne omote s po 14 filmsko obloženimi tabletami po 0,5 mg vareniklina bodisi 2 pretisna omota s po 28 filmsko obloženimi tabletami po 0,5 mg vareniklina - notranje in zunanje označevanje
English: NPS AE Primary
Slovenian: aStopnja huda jakost AE;
English: Psychiatric Cohort N=4074 Varenicline Bupropion
Slovenian: psihiatrična kohorta n = 4.074 vareniklin bupropion NRT placebo število zdravljenih bolnikov AE sestavljenega glavnega opazovanega dogodka NPS, n (%)
English: 28 film-coated tablets
Slovenian: Pakiranje za vzdrževalno zdravljenje vsebuje 28 filmsko obloženih tablet
English: Croscarmellose Sodium
Slovenian: • visok krvni sladkor
English: Very common: may affect more than 1 in 10 people o Inflammation of the nose and throat, abnormal dreams, difficulty sleeping, headache, o Nausea
Slovenian: • vnetje v nosu in žrelu, nenormalne sanje, težave s spanjem, glavobol • občutek siljenja na bruhanje
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.
Slovenian: pretisne omote iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju, ki vsebuje en prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg ter 14 filmsko obloženimi tabletami po 1 mg in 1 prozoren pretisni omot z 28 ali 2 prozorna pretisna omota s 14 filmsko obloženimi tabletami po 1 mg, ter pretisne omote iz PCTFE/PVC z aluminijasto prekrivno folijo v dveh sekundarnih, toplotno zavarjenih pakiranjih, od katerih vsako vsebuje 56 filmsko obloženih tablet po 1 mg.
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets
Slovenian: CHAMPIX 0,5 mg filmsko obložene tablete
English: Indigo Carmine Aluminium Lake (E132) Triacetin
Slovenian: Filmska obloga hipromeloza titanov dioksid (E171) makrogol 400 indigotin (E132) triacetin
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.
Slovenian: 1 toplotno zavarjeno pakiranje, ki vsebuje 11 filmsko obloženih tablet po 0,5 mg vareniklina ter 14 filmsko obloženih tablet po 1 mg vareniklina in 1 pretisni omot z 28 ali 2 pretisna omota s 14 filmsko obloženimi tabletami po 1 mg vareniklina, ter 2 toplotno zavarjeni pakiranji, od katerih vsako vsebuje 2 pretisna omota z 28 ali 4 pretisne omote s 14 filmsko obloženimi tabletami po 1 mg vareniklinazunanje in notranje označevanje
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
Slovenian: Škatla z 1 pretisnim omotom, ki vsebuje 11 filmsko obloženih tablet po 0,5 mg vareniklina in 1 pretisnim omotom, ki vsebuje 14 filmsko obloženih tablet po 1 mg vareniklina
English: Pollakiuria, nocturia
Slovenian: Bolezni sečil Občasni polakisurija, nikturija
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 1 mg film-coated tablets
Slovenian: CHAMPIX 1 mg filmsko obložene tablete
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.
Slovenian: - Pakiranja za vzdrževalno zdravljenje, ki vsebujejo 2 ali 4 prozorne pretisne omote s po 14 filmsko obloženimi tabletami ali 2 prozorna pretisna omota s po 28 filmsko obloženimi tabletami CHAMPIX 1 mg, ki so zavarjeni v kartonskem pakiranju.
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.
Slovenian: - Pakiranje za začetek zdravljenja v zunanji škatli, ki vsebuje 1 pakiranje z 1 prozornim pretisnim omotom z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg ter 14 filmsko obloženimi tabletami CHAMPIX 1 mg in 1 prozornim pretisnim omotom z 28 ali 2 prozornima pretisnima omotoma s 14 filmsko obloženimi tabletami CHAMPIX 1 mg, ki sta zavarjena v kartonskem pakiranju, ter 2 pakiranji, od katerih vsako vsebuje 2 prozorna pretisna omota z 28 ali 4 prozorne pretisne omote s 14 filmsko obloženimi tabletami CHAMPIX 1 mg, ki so zavarjeni v kartonskem pakiranju.
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg
Slovenian: CHAMPIX 0,5 mg
English: Non-psychiatric Cohort N=3984 Varenicline Bupropion
Slovenian: nepsihiatrična kohorta n = 3.984 vareniklin bupropion NRT placebo število zdravljenih bolnikov AE sestavljenega glavnega opazovanega dogodka NPS, n (%)
English: Blood pressure increased, hot flush Respiratory, thoracic and mediastinal disorders
Slovenian: • zvišan krvni tlak, vročinski oblivi
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.
Slovenian: - Pakiranje za začetek zdravljenja, ki vsebuje 2 pretisna omota; 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg in 1 prozoren pretisni omot s 14 filmsko obloženimi tabletami CHAMPIX 1 mg v škatli.
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.
Slovenian: - Pakiranje za začetek zdravljenja, ki vsebuje 2 pretisna omota; 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg in 1 prozoren pretisni omot s 14 filmsko obloženimi tabletami CHAMPIX 1 mg, ki sta zavarjena v kartonskem pakiranju.
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
Slovenian: Pretisni omot s 14 in 28 filmsko obloženimi tabletami po 0,5 mg vareniklina v toplotno zavarjenem pakiranju
English: PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju s 112 filmsko obloženimi tabletami po 1 mg v škatli.
English: EU/1/06/360/023
Slovenian: EU/1/06/360/012 EU/1/06/360/023
English: 2.99 (2.33, 3.83), P<0.0001
Slovenian: s placebom 2,99 (2,33; 3,83), p < 0,0001 2,50 (1,90; 3,29), p < 0,0001 bupropion v prim.
English: In this 52-week duration study, patients received treatment for 12 weeks, followed by a 40-week non-treatment follow-up phase.
Slovenian: V tej 52 tednov trajajoči študiji so bolniki zdravilo prejemali 12 tednov, temu pa je sledilo 40 tednov dolgo obdobje spremljanja, med katerim bolniki zdravila niso prejemali.
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.
Slovenian: pretisne omote iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju, ki vsebuje en prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg ter 14 filmsko obloženimi tabletami po 1 mg in 1 prozoren pretisni omot z 28 ali 2 prozorna pretisna omota s 14 filmsko obloženimi tabletami po 1 mg, ter pretisne omote iz PVC z aluminijasto prekrivno folijo v dveh sekundarnih, toplotno zavarjenih pakiranjih, od katerih vsako vsebuje 56 filmsko obloženih tablet po 1 mg.
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.
Slovenian: - Pakiranje za začetek zdravljenja, ki vsebuje 2 pretisna omota; 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg ter 14 filmsko obloženimi tabletami CHAMPIX 1 mg in 1 prozoren pretisni omot z 28 ali 2 prozorna pretisna omota s 14 filmsko obloženimi tabletami CHAMPIX 1 mg, ki sta zavarjena v kartonskem pakiranju.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju s 112 filmsko obloženimi tabletami po 1 mg v škatli.
English: PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju s 140 filmsko obloženimi tabletami po 1 mg v škatli.
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.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju z 28 filmsko obloženimi tabletami po 0,5 mg.
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
Slovenian: Toplotno zavarjeno pakiranje, ki vsebuje bodisi 2 ali 4 pretisne omote s po 14 filmsko obloženimi tabletami po 1 mg vareniklina bodisi 2 pretisna omota s po 28 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje
English: Fungal infection, viral infection Blood and lymphatic system disorders Rare
Slovenian: Redki glikozurija, poliurija Motnje reprodukcije in dojk Občasni menoragija
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.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju z 28 filmsko obloženimi tabletami po 0,5 mg.
English: Scotoma, scleral discolouration, mydriasis, photophobia, myopia, lacrimation increased
Slovenian: Redki skotom, obarvanje beločnice, midriaza, fotofobija, miopija, močnejše solzenje Ušesne bolezni, vključno z motnjami labirinta Občasni tinitus
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju s 140 filmsko obloženimi tabletami po 1 mg v škatli.
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.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju s 56 filmsko obloženimi tabletami po 0,5 mg.
English: PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju s 56 filmsko obloženimi tabletami po 1 mg v škatli.
English: Severe cutaneous reactions, including Stevens Johnson Syndrome and
Slovenian: Poročali so tudi o primerih hudih kožnih reakcij, vključno z multiformnim eritemom (vrsta izpuščaja) in Stevens-Johnsonovim sindromom
English: Heat sealed card pack containing 2 blister packs of 28 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets- inner and outer labelling
Slovenian: Toplotno zavarjeno pakiranje, ki vsebuje 2 pretisna omota z 28 ali 4 pretisne omote s 14 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 0.5 mg varenicline film-coated tablets
Slovenian: Nalepka za plastenko iz polietilena velike gostote (HDPE) s 56 filmsko obloženimi tabletami po 0,5 mg vareniklina
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.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju s 56 filmsko obloženimi tabletami po 0,5 mg.
English: Sealed white HDPE bottle pack, with a child resistant screw cap, in a carton, containing 56 x CHAMPIX 1 mg film-coated tablets.
Slovenian: - Pakiranje z zapečateno belo plastenko iz HDPE z zaporko, varno za otroke, v škatli, ki vsebuje 56 filmsko obloženih tablet CHAMPIX 1 mg. - Pakiranje z zapečateno belo plastenko iz HDPE z zaporko, varno za otroke, v škatli, ki vsebuje 56 filmsko obloženih tablet CHAMPIX 0,5 mg.
English: Continuous Abstinence Rates in Subjects Treated with Champix versus Placebo
Slovenian: Stopnje trajne abstinence pri preskušancih, zdravljenih z zdravilom Champix ali placebom CHAMPIX n = 249
English: Heat sealed card pack containing 1 blister pack of 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 - inner and outer labelling.
Slovenian: Toplotno zavarjeno pakiranje, ki vsebuje 1 pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina ter 14 filmsko obloženimi tabletami po 1 mg vareniklina in 1 pretisni omot z 28 ali 2 pretisna omota s 14 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju s 56 filmsko obloženimi tabletami po 1 mg v škatli.
English: Seizures
Slovenian: Odmerek
English: PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju z 28 filmsko obloženimi tabletami po 1 mg v škatli.
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.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju z 28 filmsko obloženimi tabletami po 1 mg.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju z 28 filmsko obloženimi tabletami po 1 mg v škatli.
English: Get emergency medical help right away if you have symptoms of a heart attack or stroke.
Slovenian: Ob znakih srčnega infarkta ali možganske kapi takoj poiščite nujno zdravniško pomoč.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS One blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets, heat sealed card
Slovenian: En pretisni omot z 28 ali 2 pretisna omota s 14 filmsko obloženimi tabletami po 1 mg vareniklina v toplotno zavarjenem pakiranju
English: PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju z 28 filmsko obloženimi tabletami po 1 mg.
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.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju, ki vsebuje 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg in drug prozoren pretisni omot s 14 filmsko obloženimi tabletami po 1 mg v škatli.
English: Varenicline vs Bupropion 1.49 (1.20, 1.85), P=0.0003
Slovenian: z bupropionom 1,49 (1,20; 1,85), p = 0,0003 1,41 (1,11; 1,79), p = 0,0047 vareniklin v prim.
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.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju s 56 filmsko obloženimi tabletami po 1 mg.
English: PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju s 56 filmsko obloženimi tabletami po 1 mg.
English: Tabulated summary of adverse reactions
Slovenian: Preglednica neželenih učinkov
English: No dosage adjustment is recommended based on concomitant cimetidine administration in subjects with normal renal function or in patients with mild to moderate renal impairment.
Slovenian: Pri osebah z normalnim delovanjem ledvic in pri bolnikih z blago do zmerno okvaro ledvic med sočasno uporabo cimetidina ni treba prilagoditi odmerka.
English: 2.30 (1.83, 2.90), P<0.0001
Slovenian: s placebom2,30 (1,83; 2,90), p < 0,0001 2,00 (1,56; 2,55), p < 0,0001 vareniklin v prim.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate).
Slovenian: Ena 0,5 mg filmsko obložena tableta vsebuje 0,5 mg vareniklina (v obliki vareniklinijevega tartrata).
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.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju, ki vsebuje 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg in drug prozoren pretisni omot s 14 filmsko obloženimi tabletami po 1 mg v škatli.
English: EU/1/06/360/003 EU/1/06/360/008 EU/1/06/360/012 EU/1/06/360/014 EU/1/06/360/019 EU/1/06/360/023 EU/1/06/360/025 EU/1/06/360/026
Slovenian: EU/1/06/360/014 EU/1/06/360/019 EU/1/06/360/023 EU/1/06/360/025 EU/1/06/360/026
English: hoarseness, hay fever, throat irritation, congested sinuses, excess mucous from nose causing cough, runny nose o Red blood in stools, irritated stomach, change of bowel habit, belching, mouth ulcers,
Slovenian: • rdeča kri v blatu, razdražen želodec, spremembe pri navadah izločanja blata, riganje,
English: Haematochezia, gastritis, change of bowel habit, eructation, aphthous stomatitis, gingival pain Haematemesis, abnormal faeces, tongue coated Skin and subcutaneous tissue disorders Common Uncommon
Slovenian: Občasni hematohezija, gastritis, spremembe navade v zvezi z odvajanjem blata, spahovanje, aftozni stomatitis, bolečine v dlesnih
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets, heat sealed card
Slovenian: Pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina v toplotno zavarjenem pakiranju
English: 3.24 (2.56, 4.11), P<0.0001
Slovenian: s placebom 4,00 (3,20; 5,00), p < 0,0001 3,24 (2,56; 4,11), p < 0,0001 bupropion v prim.
English: Completed suicide b
Slovenian: • samomorilne misli
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
Slovenian: Pretisni omot s 14 in 28 filmsko obloženimi tabletami po 1 mg vareniklina v toplotno zavarjenem pakiranju
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
Slovenian: Dvotedensko začetno pakiranje (začetek zdravljenja) Toplotno zavarjeno pakiranje, ki vsebuje 1 pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina in 1 pretisni omot s 14 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje
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,
Slovenian: • občutek panike, težave pri razmišljanju, nemir, nihanje razpoloženja, depresija, tesnoba,
English: 2.26 (1.80, 2.85), P<0.0001
Slovenian: s placebom 2,26 (1,80; 2,85), p < 0,0001 1,87 (1,46; 2,39), p < 0,0001 NRT v prim.
English: In addition, the table shows the subset of the composite NPS AE endpoint of severe intensity: Non-psychiatric Cohort N=3984 Varenicline Bupropion
Slovenian: Poleg tega preglednica prikazuje tudi podskupino hudih neželenih dogodkov (AE - Adverse Event) sestavljenega opazovanega dogodka NPS:
English: Risk Ratio
Slovenian: bolnikov-let izpostavljenosti razmerje tveganja
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.
Slovenian: Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju, ki vsebuje 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg in drug prozoren pretisni omot s 14 filmsko obloženimi tabletami po 1 mg.
English: Heat sealed card pack containing 1 blister pack of 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 - inner and outer labelling
Slovenian: Štiritedensko začetno pakiranje (začetek zdravljenja) Toplotno zavarjeno pakiranje, ki vsebuje 1 pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina ter 14 filmsko obloženimi tabletami po 1 mg vareniklina in 1 pretisni omot z 28 ali 2 pretisna omota s 14 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 1 mg varenicline film-coated tablets
Slovenian: Nalepka za plastenko iz polietilena velike gostote (HDPE) s 56 filmsko obloženimi tabletami po 1 mg vareniklina
English: Very common Abnormal dreams, insomnia Uncommon
Slovenian: Redki sladkorna bolezen, polidipsija Psihiatrične motnje Zelo pogosti nenormalne sanje, nespečnost
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not Applicable
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
English: indigestion, flatulence, dry mouth o Skin rash, itching o Joint ache, muscle ache, back pain o Chest pain, tiredness
Slovenian: • vnetje v nosu, sinusih in žrelu, zamašen nos, žrelo in prsni koš, hripavost, seneni nahod,
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets
Slovenian: Pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina
English: EU/1/06/360/014
Slovenian: EU/1/06/360/003 EU/1/06/360/014
English: PVC blisters with aluminium foil backing containing 1 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 secondary heat sealed card packaging.
Slovenian: Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju, ki vsebuje 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg ter 14 filmsko obloženimi tabletami po 1 mg in 1 prozoren pretisni omot z 28 ali 2 prozorna pretisna omota s 14 filmsko obloženimi tabletami po 1 mg.