FrancophonIA/ELRC3.0 huggingface dataset:
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
Slovenian: Občasni samomorilne misli, agresija, panična reakcija, nenormalno mišljenje, nemir, nihanje razpoloženja, depresija*, anksioznost*, halucinacije*, zvečan libido, zmanjšan libido
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.
Slovenian: 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.
English: Varenicline (N=5072)
Slovenian: vareniklin (n = 5.072)
English: 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:
Slovenian: 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:
English: The effects of stopping smoking
Slovenian: Učinki opustitve kajenja
English: History of psychiatric disorders
Slovenian: Psihiatrične motnje v anamnezi
English: In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.
Slovenian: Pri odvajanju od kajenja s pomočjo zdravil nastopi takoj po koncu zdravljenja povišano tveganje za ponoven začetek kajenja.
English: 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.
Slovenian: 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.
English: Hypromellose Titanium Dioxide (E171) Macrogol 400
Slovenian: Filmska obloga hipromeloza titanov dioksid (E171) makrogol 400 triacetin
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side.
Slovenian: Bele, bikonveksne tablete kapsulaste oblike z oznako "Pfizer" na eni strani in "CHX 0.5" na drugi strani.
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).
Slovenian: 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 %.
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:
Slovenian: 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:
English: CHAMPIX 1 mg film-coated tablets are light blue film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 1.0”
Slovenian: - CHAMPIX 1 mg filmsko obložene tablete so svetlomodre filmsko obložene tablete zaobljene kapsulaste oblike z oznakama "Pfizer" in "CHX 1.0"
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”
Slovenian: 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"
English: 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.
Slovenian: 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.
English: Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upperairway cough syndrome, rhinorrhoea Laryngeal pain, snoring
Slovenian: Občasni vnetje zgornjih dihal, kongestija dihal, disfonija, alergijski rinitis, draženje žrela, kongestija sinusov, sindrom kašlja zgornjih dihalnih poti (pocejanje v žrelo), rinoreja
English: 11 x 0.5 mg and 14 x 1 mg
Slovenian: filmsko obložene tablete 11 x 0,5 mg in 14 x 1 mg
English: Gastrooesophageal reflux disease, vomiting, constipation, diarrhoea, abdominal distension, abdominal pain, toothache, dyspepsia, flatulence, dry mouth
Slovenian: Pogosti gastroezofagealna refluksna bolezen, bruhanje, zaprtje, driska, napihnjenost trebuha, bolečina v trebuhu, zobobol, dispepsija, flatulenca, suhost ust
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA Holder Logo)
Slovenian: Pfizer Europe MA EEIG (kot logotip imetnika dovoljenja za promet)
English: Odds ratio CHAMPIX vs. bupropion p < 0.0001
Slovenian: razmerje obetov CHAMPIX v primerjavi z bupropionom p < 0,0001
English: Dyspnoea, cough
Slovenian: • kratka sapa, kašelj
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.
Slovenian: Med fazo dolgoročnega spremljanja brez zdravil niso merili učinkov vareniklina na hlepenje, odtegnitvene učinke in okrepitvene učinke kajenja.
English: EXPIRY DATE EXP: MM/YYYY
Slovenian: Uporabno do: MM/LLLL
English: 4-week treatment initiation pack containing: 11 x 0.5 mg film-coated tablets and
Slovenian: Štiritedensko pakiranje za začetek zdravljenja, ki vsebuje: 11 x 0,5 mg filmsko obloženih tablet in
English: PHARMACEUTICAL FORM AND CONTENTS 56 Film-coated tablets
Slovenian: Pakiranje za vzdrževalno zdravljenje, ki vsebuje 56 filmsko obloženih tablet
English: 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.
Slovenian: 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.
English: Odds ratio (95% CI)
Slovenian: razmerje obetov (95 % IZ)
English: Subjects treated with CHAMPIX had a significantly higher Continuous Abstinence Rate compared with placebo; the key results are summarised in the following table:
Slovenian: Preskušanci, zdravljeni z zdravilom CHAMPIX, so imeli pomembno večjo stopnjo trajne abstinence v primerjavi s tistimi, ki so prejemali placebo.
English: Numbers 1 to 14 sun as symbol moon as symbol
Slovenian: Številke od 1 do 14 sonce kot simbol luna kot simbol
English: Pharmacotherapeutic group: Other nervous system drugs; Drugs used in addictive disorders; Drugs used in nicotine dependence, ATC code: N07BA03
Slovenian: Farmakoterapevtska skupina: Druga zdravila z delovanjem na živčevje; Zdravila za zdravljenje zasvojenosti; Zdravila za zdravljenje zasvojenosti z nikotinom.
English: Cerebrovascular accident, hypertonia, dysarthria, coordination abnormal, hypogeusia, circadian rhythm sleep disorder Transient loss of consciousness
Slovenian: Redki možganska kap, hipertonija, dizartrija, nenormalna koordinacija, hipogevzija, motnja cirkadianega ritma spanja
English: CHAMPIX may be linked with dizziness, sleepiness and transient loss of consciousness.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo CHAMPIX je lahko povezano z omotico, zaspanostjo in začasno izgubo zavesti.
English: 1 mg film-coated tablets of 5mm x 10mm: Light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side.
Slovenian: 1 mg filmsko obložene tablete velikosti 5 mm x 10 mm: svetlomodre, bikonveksne tablete kapsulaste oblike z oznako "Pfizer" na eni strani in "CHX 1.0" na drugi strani.
English: You may temporarily experience increased irritability, urge to smoke, depression and/or sleep disturbances when you stop taking CHAMPIX.
Slovenian: Ko prenehate jemati zdravilo CHAMPIX, se lahko začasno pojavijo povečana razdražljivost, sla po kajenju, depresija in/ali motnje spanja.
English: Treatment initiation packs
Slovenian: Pakiranja za začetek zdravljenja
English: Hepatic impairment No dosage adjustment is necessary for patients with hepatic impairment (see section 5.2).
Slovenian: Okvara jeter Bolnikom z okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: numbers 1 to 14 numbers 1 to 28 sun as symbol moon as symbol
Slovenian: Številke od 1 do 14 Številke od 1 do 28 sonce kot simbol luna kot simbol
English: However, it is not known if CHAMPIX actually increases alcohol intoxication.
Slovenian: Obstaja nekaj poročil o povečanih intoksikacijskih učinkih alkohola pri bolnikih, ki jemljejo zdravilo CHAMPIX, vendar ni znano, ali zdravilo CHAMPIX dejansko poveča zastrupitev z alkoholom.
English: Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free)
Slovenian: Tel: 1800 633 363 (toll free)
English: Carton pack containing 2 blister packs of 14 x 1 mg varenicline film-coated tablets or 4 blister packs of 14 x 1 mg varenicline film-coated tablets or 8 blister packs of 14 x 1 mg varenicline film-coated tablets or 10 blister packs of 14 x 1 mg varenicline film-coated tablets
Slovenian: Škatla, ki vsebuje 2 pretisna omota s po 14 filmsko obloženimi tabletami po 1 mg vareniklina ali 4 pretisne omote s po 14 filmsko obloženimi tabletami po 1 mg vareniklina ali 8 pretisnih omotov s po 14 filmsko obloženimi tabletami po 1 mg vareniklina ali 10 pretisnih omotov s po 14 filmsko obloženimi tabletami po 1 mg vareniklina
English: Numbers 1 to 28 sun as symbol moon as symbol
Slovenian: Številke od 1 do 28 sonce kot simbol luna kot simbol
English: Placebo)
Slovenian: s placebom
English: Maintenance pack
Slovenian: Pakiranje za vzdrževalno zdravljenje
English: RD (95% CI) vs Placebo
Slovenian: RD (95 % IZ) v primerjavi s placebom 1,59
English: Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking CHAMPIX, according to the instructions described in the table above.
Slovenian: Zato je pomembno, da zdravilo CHAMPIX še naprej jemljete po navodilih, ki jih navaja zgornja preglednica, razen če vam zdravnik naroči, da z zdravljenjem prekinete.
English: Oral bioavailability of varenicline is unaffected by food or time-of-day dosing.
Slovenian: Hrana in dnevni čas uporabe ne vplivata na biološko uporabnost vareniklina.
English: Subjects were randomised 1:1 to CHAMPIX 1 mg twice daily (N=249) or placebo (N=245) for 12 weeks of treatment and followed for up to 40 weeks post-treatment.
Slovenian: Preskušance so v razmerju 1 : 1 randomizirali v skupino, ki je 12 tednov prejemala zdravilo CHAMPIX 1 mg dvakrat na dan (n = 249), in skupino, ki je prejemala placebo (n = 245), nato pa so jih spremljali še do 40 tednov po zdravljenju.
English: These events included in the endpoint were adjudicated by a blinded, independent committee.
Slovenian: Te dogodke, vključene v opazovani dogodek, je presojal neodvisni odbor, ki ni vedel, katero zdravilo je posamezna skupina bolnikov prejemala.
English: There have also been reports of severe skin reactions including Erythema Multiforme (a type of rash) and Stevens-Johnson Syndrome (a serious illness with blistering of the skin, mouth, around the eyes or genitals) and serious allergic reactions including angioedema (swelling of the face, mouth, or throat).
Slovenian: (resna bolezen z mehurji na koži, v ustih, okrog oči ali spolovil), ter resnih alergijskih reakcij, vključno z angioedemom (otekanje obraza, ust ali grla).
English: Blisters: Store below 30°C HDPE Bottle: This medicinal product does not require any special storage conditions
Slovenian: Plastenka iz HDPE: Za shranjevanje zdravila niso potrebna posebna navodila.
English: Composite NPS AE Endpoint of severe intensity n (%)
Slovenian: hudi AE sestavljenega opazovanega dogodka NPS, n (%)
English: Blisters: Store below 30°C
Slovenian: Pretisni omoti: Shranjujte pri temperaturi do 30 °C.
English: For patients with moderate renal impairment who experience adverse reactions that are not tolerable, dosing may be reduced to 1 mg once daily.
Slovenian: Bolnikom z zmerno okvaro ledvic lahko odmerek zmanjšamo na 1 mg enkrat na dan, če se pri njih pojavijo neželeni učinki, ki jih ne prenesejo.
English: The fourth study showed no evidence of a higher risk of fatal and non-fatal self- harm (HR of 0.88; 95% CI: 0.52-1.49) in patients prescribed varenicline compared to patients prescribed NRT.
Slovenian: V četrti študiji pri bolnikih, zdravljenih z vareniklinom, v primerjavi z bolniki, ki so prejemali NRT, niso ugotovili dokazov za povečano tveganje za samopoškodovanje s smrtnim izidom in brez smrtnega izida (HR 0,88; 95 % IZ: 0,52-1,49).
English: 1.74 (1.43, 2.10), P<0.0001
Slovenian: 1,74 (1,43; 2,10), p < 0,0001 1,62 (1,32; 1,99), p < 0,0001
English: Treatment Comparisons: Odds ratio (95% CI), p value Varenicline vs Placebo
Slovenian: Primerjave zdravljenj: razmerje obetov (95 % IZ), vrednost p vareniklin v prim.
English: Light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side.
Slovenian: Svetlomodre, bikonveksne tablete kapsulaste oblike z oznako "Pfizer" na eni strani in "CHX 1.0" na drugi strani.
English: In this 24-week study, patients received treatment for 12 weeks followed by a 12 week non-treatment follow up phase.
Slovenian: V tej 24 tednov trajajoči študiji so bolniki zdravilo prejemali 12 tednov, temu obdobju pa je sledila 12 tednov trajajoča faza spremljanja.
English: Varenicline did not affect the pharmacokinetics of metformin.
Slovenian: Vareniklin ni vplival na farmakokinetiko metformina, metformin pa ni vplival na farmakokinetiko vareniklina.
English: Reproductive system and breast disorders Uncommon
Slovenian: Organski sistem Neželeni učinki zdravila Infekcijske in parazitske bolezni Zelo pogosti
English: NRT N=1016 n (%)
Slovenian: n = 1.016 n (%)
English: Varenicline N=990 n (%)
Slovenian: vareniklin n = 990 n (%)
English: - 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: Chest discomfort, influenza like illness, pyrexia, asthenia, malaise Feeling cold, cyst
Slovenian: Občasni nelagodje v prsnem košu, gripi podobna bolezen, pireksija, astenija, splošno slabo počutje
English: High-Dose Varenicline vs Placebo Low-Dose Varenicline vs Placebo
Slovenian: velik odmerek vareniklina v primerjavi s placebom majhen odmerek vareniklina v primerjavi s placebom
English: There have been post-marketing reports of hypersensitivity reactions including angioedema in patients treated with varenicline.
Slovenian: Pri bolnikih, zdravljenih z vareniklinom, obstajajo iz obdobja trženja poročila o preobčutljivostnih reakcijah, vključno z angioedemom.
English: In these 52-week duration studies, patients received treatment for 12 weeks, followed by a 40-week non-treatment phase.
Slovenian: V teh 52-tedenskih študijah so bolniki 12 tednov dobivali zdravilo, sledila pa je 40-tedenska faza brez njega.
English: - Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
Slovenian: - Ena 1 mg filmsko obložena tableta vsebuje 1 mg vareniklina (v obliki vareniklinijevega tartrata).
English: CHAMPIX 0.5 mg CHAMPIX 1 mg Film-coated tablets Varenicline
Slovenian: CHAMPIX 0,5 mg CHAMPIX 1 mg filmsko obložene tablete vareniklin
English: The 4 week (week 9-12) CQR for varenicline and placebo was 53.9% and 19.4%, respectively (difference=34.5%, 95% CI: 27.0%42.0%) and the CA week 9-24 was 35.2% (varenicline) vs. 12.7% (placebo) (difference=22.5%, 95% CI: 15.8% - 29.1%).
Slovenian: Do 4 tedne trajajoče (od 9. do 12. tedna) opustitve kajenja je prišlo pri 53,9 % bolnikov, ki so prejemali vareniklin in pri 19,4 % bolnikov, ki so prejemali placebo (razlika = 34,5 %, 95 % IZ: 27,0 % - 42,0 %), do trajne opustitve kajenja od 9. do 24 tedna pa je prišlo pri 35,2 % bolnikov, ki so prejemali vareniklin in pri 12,7 % bolnikov, ki so prejemali placebo (razlika = 22,5 %, 95 % IZ: 15,8 % - 29,1 %).
English: Anxiety a
Slovenian: PRILOGA I
English: Varenicline vs Bupropion 1.77 (1.46, 2.14), P<0.0001
Slovenian: z bupropionom 1,77 (1,46; 2,14), p < 0,0001 1,74 (1,41; 2,14), p < 0,0001 vareniklin v prim.
English: Hyperglycaemia
Slovenian: Občasni hiperglikemija
English: Patients in this study (n=1,927) received open-label CHAMPIX 1 mg twice daily for 12 weeks.
Slovenian: Bolniki (n = 1.927) so v tej študiji, ki je bila prvih 12 tednov odprta, v tem obdobju dobivali zdravilo CHAMPIX v odmerku 1 mg dvakrat na dan. Bolniki, ki so do 12. tedna opustili kajenje, so bili nato randomizirani na prejemanje bodisi zdravila CHAMPIX (1 mg dvakrat na dan) ali placeba za dodatnih 12 tednov; celotna študija je trajala 52 tednov.
English: Follow-on (maintenance) packs containing 2, 4, 8, or 10 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
Slovenian: - Pakiranja za vzdrževalno zdravljenje, ki vsebujejo 2, 4, 8 ali 10 prozornih pretisnih omotov s po 14 filmsko obloženimi tabletami CHAMPIX 1 mg v škatli.
English: Bupropion Varenicline did not alter the steady-state pharmacokinetics of bupropion.
Slovenian: Bupropion Vareniklin ni spremenil farmakokinetike bupropiona v stanju dinamičnega ravnovesja.
English: Varenicline N=1026 n (%)
Slovenian: vareniklin n = 1.026 n (%)
English: Bupropion vs Placebo
Slovenian: CHAMPIX bupropion placebo razmerje obetov
English: AE, adverse event; aGrade = severe intensity AE; bGrade = moderate and severe intensity AE; NRT=Nicotine replacement therapy patch
Slovenian: bStopnja zmerna in huda jakost AE; NRT
English: Deaths and cardiovascular events were adjudicated by a blinded, independent committee.
Slovenian: Smrti in srčnožilne dogodke je presojal neodvisni odbor, ki ni vedel, katero zdravilo je posamezna skupina bolnikov prejemala.
English: How to store CHAMPIX
Slovenian: Shranjevanje zdravila CHAMPIX
English: NRT N=1006 n (%)
Slovenian: n = 1.006 n (%)
English: High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil/polyethylene induction seal containing 56 x 0.5 mg film-coated tablets Not all pack sizes may be marketed.
Slovenian: Plastenka iz polietilena velike gostote (HDPE) s polipropilensko, za otroke varno zaporko, indukcijsko zapečaten z aluminijasto folijo/polietilenom, ki vsebuje 56 filmsko obloženih tablet po 0,5 mg.
English: 1.52 (1.23, 1.89), P=0.0001
Slovenian: 1,52 (1,23; 1,89), p = 0,0001 1,51 (1,19; 1,93), p = 0,0008
English: Dosing should begin at 0.5 mg once daily for the first 3 days then increased to 1 mg once daily.
Slovenian: Priporočeni odmerek zdravila CHAMPIX pri bolnikih s hudo okvaro ledvic (ocenjeni očistek kreatinina < 30 ml/min) je 1 mg enkrat na dan. Odmerjanje je treba začeti z 0,5 mg enkrat na dan prve 3 dni in nato povečati do 1 mg enkrat na dan.
English: Odds ratio in CAR 9-12 (95% CI) [p-value]
Slovenian: velik odmerek vareniklina majhen odmerek vareniklina placebo primerjave zdravljenj razmerje obetov v CAR 9-12 (95 % IZ) [vrednost p]
English: High-density polyethylene (HDPE) bottle with polypropylene child resistant closure and an aluminium foil / polyethylene induction seal containing 56 x 1 mg film-coated tablets Not all pack sizes may be marketed.
Slovenian: Plastenka iz polietilena velike gostote (HDPE) s polipropilensko, za otroke varno zaporko, indukcijsko zapečaten z aluminijasto folijo/polietilenom, ki vsebuje 56 filmsko obloženih tablet po 1 mg.
English: Very common Nausea
Slovenian: • čezmerna žeja
English: Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
Slovenian: Ena 1 mg filmsko obložena tableta vsebuje 1 mg vareniklina (v obliki vareniklinijevega tartrata).
English: Varenicline did not alter the steady-state pharmacokinetics of digoxin.
Slovenian: Vareniklin ni spremenil farmakokinetike digoksina v stanju dinamičnega ravnovesja.
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.
Slovenian: V obdobju trženja so pri bolnikih, ki so poskušali opustiti kajenje z zdravilom CHAMPIX, poročali o spremembah v vedenju ali razmišljanju, anksioznosti, psihozi, nihanju razpoloženja, nasilnem vedenju, depresiji, samomorilnih mislih in vedenju ter poskusih samomora.
English: NAME OF THE MEDICINAL PRODUCT CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets
Slovenian: CHAMPIX 0,5 mg filmsko obložene tablete CHAMPIX 1 mg filmsko obložene tablete
English: Blood pressure increased, hot flush Respiratory, thoracic and mediastinal disorders Common
Slovenian: Žilne bolezni Občasni zvišan krvni tlak, vročinski oblivi Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti dispneja, kašelj
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.
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 0,5 mg, ki so zavarjeni v kartonskem pakiranju.
English: 1.65 (1.24, 2.20), P=0.0007
Slovenian: 1,96 (1,51; 2,54), p < 0,0001 1,65 (1,24; 2,20), p = 0,0007
English: 12-week Treatment Initiation Pack
Slovenian: Štiritedensko pakiranje (za začetek zdravljenja)
English: A gradual approach to quitting smoking with CHAMPIX should be considered for patients who are not able or willing to quit abruptly.
Slovenian: Pri bolnikih, ki kajenja niso sposobni ali pripravljeni opustiti nenadoma, pride v poštev postopna opustitev z uporabo zdravila CHAMPIX.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg or 1 mg varenicline (as tartrate).
Slovenian: Ena tableta vsebuje 0,5 mg ali 1 mg vareniklina (v obliki vareniklinijevega tartrata).
English: Tablet Core - CHAMPIX 0.5 mg and 1 mg film-coated tablets Cellulose, Microcrystalline
Slovenian: Jedro tablete - CHAMPIX 0,5 mg in 1 mg filmsko obložene tablete mikrokristalna celuloza brezvodni kalcijev hidrogenfosfat premreženi natrijev karmelozat brezvodni koloidni silicijev dioksid magnezijev stearat