FrancophonIA/ELRC3.0 huggingface dataset:
English: Study in Subjects with and without a History of Psychiatric Disorder: Varenicline was evaluated in a randomised, double-blind, active and placebo-controlled study that included subjects with a history of psychiatric disorder (psychiatric cohort, N=4074) and subjects without a history of psychiatric disorder (non-psychiatric cohort, N=3984).
Croatian: Ispitivanje neuropsihijatrijske sigurnosti u ispitanika sa ili bez psihijatrijskog poremećaja u anamnezi Vareniklin je procjenjivan u randomiziranom, dvostruko slijepom ispitivanju kontroliranom djelatnom tvari i placebom koje je uključivalo ispitanike s psihijatrijskim poremećajem u anamnezi (psihijatrijska kohorta, N=4074) i ispitanike bez psihijatrijskog poremećaja u anamnezi (nepsihijatrijska kohorta, N=3984).
English: Subjects who experienced an adverse event of a concern during previous treatment were excluded.
Croatian: Nisu uključivani ispitanici u kojih su se javile povezane nuspojave tijekom prethodnog liječenja.
English: 4-week treatment initiation pack containing: 11 x 0.5 mg film-coated tablets and
Croatian: Četverotjedno pakiranje za početak liječenja koje sadrži: 11 x 0,5 mg filmom obloženih tableta i
English: In subjects with severe renal impairment (estimated creatinine clearance < 30 ml/min), varenicline exposure was increased 2.1-fold.
Croatian: U ispitanika s teškim oštećenjem bubrega (procijenjeni klirens kreatinina < 30 ml/min) izloženost vareniklinu povećala se 2,1 puta.
English: 11 x 0.5 mg and 14 x 1 mg
Croatian: filmom obložene tablete 11 x 0,5 mg i 14 x 1 mg
English: Cardiovascular safety assessment study in subjects with and without a history of psychiatric disorder The cardiovascular (CV) safety of CHAMPIX was evaluated in the Study in Subjects with and without a History of Psychiatric Disorder (parent study; see section 5.1 - Neuropsychiatric safety) and its nontreatment extension, the Cardiovascular Safety Assessment Study, which enrolled 4595 of the 6293 subjects who completed the parent study (N=8058) and followed them through week 52.
Croatian: Kardiovaskularna (KV) sigurnost lijeka CHAMPIX procijenjena je u ispitivanju u osoba sa ili bez psihijatrijskih poremećaja u anamnezi (ishodišno ispitivanje, vidjeti dio 5.1 - Ispitivanje neuropsihijatrijske sigurnosti) i u njegovom nastavku bez liječenja, Ispitivanju za procjenu kardiovaskularne sigurnosti u koje je bilo uključeno 4595 od 6293 osoba koje su završile sudjelovanje u ishodišnom ispitivanju (N=8058) i praćene su do 52. tjedna.
English: shortsightedness, watery eyes o Irregular heart beat or heart rhythm disturbances o Throat pain, snoring o Blood in vomit, abnormal stools, coated tongue o Stiff joints, rib pain o Glucose in urine, increased urine volume and frequency o Vaginal discharge, changes in sexual ability o Feeling cold, cyst o Diabetes o Sleep walking o Loss of contact with reality and unable to think or judge clearly (psychosis) o Abnormal behaviour o Severe skin reactions including Erythema Multiforme (a type of rash) and StevensJohnson Syndrome (a serious illness with blistering of the skin, mouth, around the eyes or genitals) o Serious allergic reactions including angioedema (swelling of the face, mouth, or throat)
Croatian: kratkovidnost, suzenje očiju o nepravilan rad srca ili poremećaji srčanog ritma o bol u grlu, hrkanje o povraćanje krvi, neuobičajene stolice, naslage na jeziku o ukočeni zglobovi, bol u rebrima o šećer u mokraći, povećan volumen mokraće i učestalost mokrenja o iscjedak iz rodnice, promjene u spolnoj potenciji o osjećaj hladnoće, cista o šećerna bolest o mjesečarenje o gubitak dodira sa stvarnošću i nemogućnost jasnog razmišljanja ili rasuđivanja (psihoza) o neuobičajeno ponašanje o teške kožne reakcije uključujući multiformni eritem (vrsta osipa) i Stevens-Johnsonov sindrom (ozbiljna bolest s mjehurićima na koži, ustima, oko očiju ili genitalija) o ozbiljne alergijske reakcije uključujući angioedem (oticanje lica, usta ili grla)
English: Hypromellose Titanium Dioxide (E171) Macrogol 400
Croatian: Film ovojnica hipromeloza titanijev dioksid (E171) makrogol 400
English: Cardiovascular death occurred in 0.3% of patients in the CHAMPIX arm and 0.6% of patients in the placebo arm over the course of the 52-week study.
Croatian: Tijekom ispitivanja u trajanju od 52 tjedna smrt zbog kardiovaskularnog razloga nastupila je u 0,3% bolesnika liječenih lijekom CHAMPIX i u 0,6% ispitanika koji su primali placebo.
English: Hazard Ratio (95% CI) vs placebo
Croatian: Omjer hazarda (95% CI) naspram placeba
English: Rare Not known
Croatian: - Nepoznato:
English: Champix is for oral use.
Croatian: Champix je namijenjen za primjenu kroz usta.
English: There were similar rates of all-cause mortality (CHAMPIX 6 [0.14%]; placebo 7 [0.25%]) and cardiovascular mortality (CHAMPIX 2 [0.05%]; placebo 2 [0.07%]) in the CHAMPIX arms compared with the placebo arms in the meta-analysis.
Croatian: U metaanalizi su u skupinama koje su primale CHAMPIX i u skupinama koje su primale placebo zabilježene podjednake stope smrtnosti zbog bilo kojeg uzroka (CHAMPIX 6 [0,14%]; placebo 7 [0,25%]) i smrtnosti zbog kardiovaskularnih uzroka (CHAMPIX 2 [0,05%]; placebo 2 [0,07%]).
English: Children and adolescents CHAMPIX is not recommended for use in paediatric patients as efficacy was not demonstrated.
Croatian: Primjena lijeka CHAMPIX ne preporučuje se u pedijatrijskih bolesnika jer nije dokazana njegova djelotvornost u ovoj dobnoj skupini.
English: The following table shows the rates of the composite NPS adverse event primary endpoint by treatment group and the RDs (95% CI) vs placebo in the psychiatric cohort.
Croatian: Sljedeća tablica prikazuje stope kompozitnog primarnog ishoda NPS štetnog događaja po terapijskoj skupini i razlike u rizicima (95% CI) naspram placeba u psihijatrijskoj kohorti.
English: Varenicline did not affect the pharmacokinetics of metformin.
Croatian: Vareniklin nije utjecao na farmakokinetiku metformina.
English: Treatment Comparisons: Odds ratio (95% CI), p value Varenicline vs Placebo
Croatian: Usporedbe liječenja: Omjer izgleda (95% CI), p vrijednost Vareniklin naspram placeba
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.
Croatian: 4. - 7. dan Od 4. do 7. dana morate uzeti jednu bijelu CHAMPIX 0,5 mg filmom obloženu tabletu dvaput na dan, jednom ujutro i jednom navečer, svakoga dana otprilike u isto vrijeme.
English: Rare: may affect up to 1 in 1,000 people o Excessive thirst o Feeling unwell or unhappy, slow thinking o Stroke o Increased muscle tension, difficulty with speech, difficulty with coordination, reduced sense of taste, altered sleep pattern o Disturbed vision, eyeball discolouration, dilated pupils, sensitivity to light,
Croatian: o prekomjerna žeđ o osjećati se loše ili nesretno, sporo razmišljanje o moždani udar o povećana napetost mišića, poteškoće s govorom, poteškoće s koordinacijom, smanjeni osjet okusa, promijenjen obrazac spavanja o poremećaj vida, promjena boje očne jabučice, proširene zjenice, osjetljivost na svjetlost,
English: Metformin had no effect on varenicline pharmacokinetics.
Croatian: Metformin nije utjecao na farmakokinetiku vareniklina.
English: CHAMPIX 1 mg film-coated tablets are light blue film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 1.0”
Croatian: - CHAMPIX 1 mg filmom obložene tablete su svijetloplave filmom obložene tablete u obliku kapsule, s oznakama “Pfizer” i “CHX 1.0”
English: The study in patients with stable cardiovascular disease described above was included in the meta-analysis.
Croatian: U metaanalizu je bilo uključeno i prethodno opisano ispitivanje s bolesnicima sa stabilnom kardiovaskularnom bolešću.
English: In this study, infants exposed to CHAMPIX in utero as compared to infants born to mothers who smoked during pregnancy had lower rates of congenital malformations (3.6% vs 4.3%), stillbirth (0.3% vs 0.5%), preterm birth (7.5% vs 7.9%), small for gestational age (12.5% vs 17.1%), and premature rupture of membrane (3.6% vs 5.4%).
Croatian: U ovom su ispitivanju u dojenčadi koja je bila izložena lijeku CHAMPIX in utero zabilježene niže stope kongenitalnih malformacija (3,6% naspram 4,3%), mrtvorođenih (0,3% naspram 0,5%), prijevremeno rođenih (7,5% naspram 7,9%), malog rasta za gestacijsku dob (12,5% naspram 17,1%) i prijevremenog prsnuća plodovih ovoja (3,6% naspram 5,4%) u usporedbi s dojenčadi majki koje su pušile tijekom trudnoće.
English: Semen analysis abnormal, C-reactive protein increased, blood calcium decreased * Frequencies are estimated from a post-marketing, observational cohort study
Croatian: Pretrage često odstupanja u rezultatima testova jetrene funkcije rijetko poremećene vrijednosti sjemena, povišena vrijednost C-reaktivnog proteina, smanjena vrijednost kalcija u krvi * učestalost procijenjena na temelju opservacijskog kohortnog ispitivanja nakon stavljanja lijeka u promet
English: Neuropsychiatric Safety Study in Subjects with and without a History of Psychiatric Disorder:
Croatian: Procjena kardiovaskularne sigurnosti u osoba sa ili bez psihijatrijskih poremećaja u anamnezi
English: You may temporarily experience increased irritability, urge to smoke, depression and/or sleep disturbances when you stop taking CHAMPIX.
Croatian: Nakon što prestanete uzimati CHAMPIX, privremeno možete iskusiti povećanu razdražljivost, nagon za pušenjem, depresiju i/ili poremećaje spavanja.
English: There is currently limited clinical experience with the use of CHAMPIX among black people to determine clinical efficacy.
Croatian: Na temelju dosadašnjeg ograničenog iskustva ne može se utvrditi klinička djelotvornost lijeka CHAMPIX u bolesnika crne rase.
English: 12-to-17-Year Olds n/N (%)
Croatian: Bolesnici u dobi od 12 do 17 godina n/N (%)
English: Varenicline did not alter the pharmacokinetics of warfarin.
Croatian: Vareniklin nije izmijenio farmakokinetiku varfarina.
English: The primary study endpoint was the CO-confirmed continuous abstinence rate from week 13 through week 24 in the double-blind treatment phase.
Croatian: Primarna mjera ishoda ispitivanja bila je stopa kontinuirane apstinencije potvrđene izdisajnim testom ugljikova monoksida od 13. do 24. tjedna u dvostruko slijepoj fazi liječenja.
English: There have been post-marketing reports of hypersensitivity reactions including angioedema in patients treated with varenicline.
Croatian: Nakon stavljanja lijeka u promet u bolesnika liječenih vareniklinom prijavljene su reakcije preosjetljivosti, uključujući angioedem.
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.
Croatian: 0,5 mg filmom obložene tablete dimenzija 4 mm x 8 mm: Bijele, bikonveksne tablete oblika kapsule, s utisnutom oznakom "Pfizer" na jednoj i "CHX 0.5" na drugoj strani.
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.
Croatian: Ispitanici su randomizirani da dobivaju CHAMPIX 1 mg dvaput na dan (n=760) ili placebo (n=750) tijekom 24 tjedna i praćeni su nakon liječenja do 52. tjedna.
English: Prothrombin time (INR) was not affected by varenicline.
Croatian: Vareniklin nije utjecao na protrombinsko vrijeme (INR).
English: NRT N=1006 n (%)
Croatian: N=1006 n (%)
English: Hepatic impairment No dosage adjustment is necessary for patients with hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem jetre (vidjeti dio 5.2).
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.
Croatian: Ispitanici su randomizirani 1:1 da primaju CHAMPIX u dozi od 1 mg dvaput na dan (N=249) ili placebo (N=245) tijekom 12 tjedana liječenja, nakon čega je uslijedilo razdoblje praćenja do 40 tjedana.
English: NRT vs Placebo
Croatian: NRT naspram placeba
English: White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side.
Croatian: Bijele, bikonveksne tablete oblika kapsule, s utisnutom oznakom "Pfizer" na jednoj i "CHX 0.5" na drugoj strani.
English: 154 x 1 mg film-coated tablets
Croatian: 154 filmom obloženih tableta od 1 mg
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%).
Croatian: Stopa kontinuiranog prestanka pušenja tijekom 4 tjedna (od 9. do 12. tjedna) iznosila je 53,9% za vareniklin, a 19,4% za placebo (razlika = 34,5%, 95% CI: 27,0% - 42,0%), a kontinuirane apstinencije od 9. do 24. tjedna bila je 35,2% (vareniklin) naspram 12,7% (placebo) (razlika = 22,5%, 95% CI: 15,8% - 29,1%).
English: Odds ratio (95% CI), p value
Croatian: Omjer izgleda (95% CI), p vrijednost
English: PHARMACEUTICAL FORM AND CONTENTS 56 Film-coated tablets
Croatian: Pakiranje za terapiju održavanja koje sadrži 56 filmom obloženih tableta
English: Study in subjects with stable schizophrenia or schizoaffective disorder Varenicline safety and tolerability was assessed in a double-blind study of 128 smokers with stable schizophrenia or schizoaffective disorder, on antipsychotic medication, randomised 2:1 to varenicline (1 mg twice daily) or placebo for 12 weeks with 12-week non-drug follow-up.
Croatian: Ispitivanje s ispitanicima sa stabilnom shizofrenijom ili shizoafektivnim poremećajem: Sigurnost i podnošljivost vareniklina ocijenjeni su u dvostruko slijepom ispitivanju u kojem je sudjelovalo 128 pušača sa stabilnom shizofrenijom ili shizoafektivnim poremećajem, liječenih antipsihoticima.
English: Anxiety disorders and symptoms Depressed mood disorders and disturbances Mood disorders and disturbances NEC*
Croatian: Depresivni poremećaji i smetnje
English: During treatment MACE, n (%)
Croatian: MACE, n (%)
English: pain in the gums o Reddening of the skin, acne, increased sweating, night sweats o Muscle spasms, chest wall pain o Abnormally frequent urination, urination at night o Increased menstrual flow o Chest discomfort, flu like illness, fever, feeling weak or unwell o High blood sugar o Heart attack o Suicidal thoughts o Changes in thinking or behaviour (such as aggression)
Croatian: ulceracije u ustima, bol u desnima o crvenilo kože, akne, pojačano znojenje, noćno znojenje o grčevi u mišićima, bol u stijenci prsnog koša o poremećena učestalost mokrenja, mokrenje noću o pojačana mjesečnica o nelagoda u prsnom košu, bolest nalik gripi, vrućica, osjećaj slabosti ili nemoći o visoki šećer u krvi o srčani udar o suicidalne misli o promjene u razmišljanju ili ponašanju (poput agresije)
English: 4-week treatment initiation pack
Croatian: Četverotjedno pakiranje za početak liječenja
English: NRT N=1016 n (%)
Croatian: N=1016 n (%)
English: hallucinations, changes in sex drive o Seizure, tremor, feeling sluggish, less sensitive to touch o Conjunctivitis, eye pain o Ringing in the ears o Angina, rapid heart rate, palpitations, increased heart rate o Increased blood pressure, hot flush o Inflammation of nose, sinuses and throat, congestion of nose, throat and chest,
Croatian: halucinacije, promjene spolnog nagona o napadaji, nevoljno drhtanje, osjećaj tromosti, smanjena osjetljivost na dodir o konjuktivitis, bol u oku o zvonjava u ušima o angina, brzi ritam srca, osjećaj lupanja srca, ubrzani otkucaji srca o povišen krvni tlak, navale vrućine o upala nosa, sinusa i grla, kongestija nosa, grla i prsnog koša, promuklost, alergijska upala nosne sluznice, iritacija grla, začepljenje sinusa, prekomjerna sluz iz nosa koja uzrokuje kašalj, curenje nosa o crvena krv u stolici, nadraženi želudac, promjene u pražnjenju crijeva, podrigivanje,
English: Patient reported craving, withdrawal and reinforcing effects of smoking
Croatian: Žudnja, simptomi ustezanja i učinci koji potiču na pušenje koje su prijavili bolesnici
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.
Croatian: 1 mg filmom obložene tablete dimenzija 5 mm x 10 mm: Svijetloplave, bikonveksne tablete u obliku kapsule, s oznakom "Pfizer" na jednoj i "CHX 1.0" na drugoj strani.
English: Patients who stopped smoking by Week 12 were then randomised to receive either CHAMPIX (1 mg twice daily) or placebo for an additional 12 weeks for a total study duration of 52 weeks.
Croatian: Bolesnici koji su prestali pušiti do 12. tjedna zatim su randomizirani u skupinu koja je dodatnih 12 tjedana primala ili CHAMPIX (1 mg dvaput na dan) ili placebo.
English: How to store CHAMPIX
Croatian: Kako čuvati CHAMPIX
English: Common: may affect up to 1 in 10 people o Chest infection, inflammation of the sinuses o Increased weight, decreased appetite, increased appetite o Sleepiness, dizziness, changes in the way things taste o Shortness of breath, cough o Heartburn, vomiting, constipation, diarrhoea, feeling bloated, abdominal pain, toothache,
Croatian: Često: mogu se javiti u do 1 na 10 osoba o infekcija u prsnom košu, upala sinusa o povećana tjelesna težina, smanjeni tek, pojačan tek o pospanost, omaglica, promjene osjeta okusa o nedostatak zraka, kašalj o žgaravica, povraćanje, zatvor, proljev, nadutost, bol u trbuhu, zubobolja, probavne tegobe, vjetrovi, suha usta o kožni osip, svrbež o bol u zglobovima, bol u mišićima, bol u leđima o bol u prsnom košu, umor
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.
Croatian: Stoga je važno nastaviti uzimati CHAMPIX prema uputama opisanim u gornjoj tablici, osim ako Vam liječnik ne kaže da liječenje morate prekinuti.
English: Cellulose, Microcrystalline Calcium Hydrogen Phosphate Anhydrous Croscarmellose Sodium Silica, Colloidal Anhydrous Magnesium Stearate
Croatian: Jezgra tableta celuloza, mikrokristalična kalcijev hidrogenfosfat, bezvodni karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: Bupropion N=1017 n (%)
Croatian: N=1017 n (%)
English: Bupropion N=989 n (%)
Croatian: N=989 n (%)
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.
Croatian: - Pakiranja za nastavak liječenja (održavanje) koja sadrže 2, 4, 8 ili 10 prozirnih blistera s 14 CHAMPIX 1 mg filmom obloženih tableta u kutiji.
English: However, the use of varenicline, bupropion and NRT in the psychiatric cohort was not associated with a significantly increased risk of NPS adverse events in the composite primary endpoint compared with placebo (95% CIs included zero).
Croatian: Međutim, primjena vareniklina, bupropiona i NRT-a u psihijatrijskoj kohorti nije bila povezana sa značajno povećanim rizikom od NPS štetnih događaja u kompozitnom primarnom ishodu u usporedbi s placebom (95 %-tni intervali pouzdanosti uključivali su nulu).
English: Maintenance pack
Croatian: Pakiranja za terapiju održavanja
English: High-Dose Varenicline vs Placebo Low-Dose Varenicline vs Placebo
Croatian: Niska doza vareniklina naspram placeba
English: Continuous abstinence rate between weeks 9-12 was 35.9% in the varenicline treatment group versus 15.6% in the placebo group (OR 3.35 (95% CI 2.16-5.21)) and between weeks 9-52 was 20.3% versus 10.4% respectively (OR 2.36 (95% CI 1.40-3.98)).
Croatian: Kontinuirana stopa apstinencije između 9. i 12. tjedna bila je 35,9% u grupi ispitanika liječenih vareniklinom naspram 15,6% u placebo grupi (OR 3,35 (95% CI 2,16-5,21)).
English: Single and multiple-dose pharmacokinetics of varenicline have been investigated in paediatric patients aged 12 to 17 years old (inclusive) and were approximately dose-proportional over the 0.5 mg to 2 mg daily dose range studied.
Croatian: Farmakokinetika pojedinačne i višestrukih doza vareniklina ispitana je u pedijatrijskih bolesnika u dobi od 12 do uključivo 17 godina.
English: In this 24-week study, patients received treatment for 12 weeks followed by a 12 week non-treatment follow up phase.
Croatian: U tom ispitivanju u trajanju od 24 tjedna bolesnici su liječeni 12 tjedana, nakon čega je uslijedila faza praćenja od 12 tjedana bez terapije.
English: The use of varenicline, bupropion and NRT in the non-psychiatric cohort was not associated with a significantly increased risk of NPS adverse events in the composite primary endpoint compared with placebo (95% CIs were lower than or included zero).
Croatian: Primjena vareniklina, bupropiona i NRT-a u nepsihijatrijskoj kohorti nije bila povezana sa značajno povećanim rizikom od NPS štetnih događaja u kompozitnom primarnom ishodu u usporedbi s placebom (95 %-tni intervali pouzdanosti bili su niži od nule ili su uključivali nulu).
English: History of psychiatric disorders
Croatian: Psihijatrijski poremećaj u anamnezi
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:
Croatian: Columbia-Suicide Severity Rating Scale, C-SSRS), bio je sličan između skupina koje su primale vareniklin i placebo tijekom liječenja i praćenja bez liječenja, kako je to prikazano u sljedećoj tablici:
English: 12-week Treatment Initiation Pack
Croatian: Pakiranje za početak 12-tjednog liječenja
English: Light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side.
Croatian: Svijetloplave, bikonveksne tablete oblika kapsule, s utisnutom oznakom "Pfizer" na jednoj i "CHX 1.0" na drugoj strani.
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.
Croatian: Ispitanici su randomizirani da primaju ili CHAMPIX u dozi od 1 mg dvaput na dan (n=353) ili placebo (n=350) tijekom 12 tjedana, nakon čega je uslijedilo razdoblje praćenja od 40 tjedana.
English: Week 1
Croatian: 1. tjedan Doza
English: There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking CHAMPIX.
Croatian: U bolesnika koji su uzimali CHAMPIX zabilježeni su slučajevi depresije, razmišljanja o samoubojstvu, samoubilačkog ponašanja i pokušaja samoubojstva.
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.
Croatian: Bočica od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu i zalijepljenim zaštitnim poklopcem od aluminijske folije/polietilena, koja sadrži 56 x 0,5 mg filmom obloženih tableta.
English: - Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate).
Croatian: - Jedna filmom obložena tableta od 0,5 mg sadrži 0,5 mg vareniklina (u obliku vareniklintartarata).
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.
Croatian: Bočica od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu i zalijepljenim zaštitnom poklopcem od aluminijske folije/polietilena, koja sadrži 56 x 1 mg filmom obloženih tableta.
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
Croatian: Kutija koja sadrži 2 blistera s 14 filmom obloženih tableta od 1 mg vareniklina ili 4 blistera s 14 filmom obloženih tableta od 1 mg vareniklina ili 8 blistera s 14 filmom obloženih tableta od 1 mg vareniklina ili 10 blistera s 14 filmom obloženih tableta od 1 mg vareniklina
English: CHAMPIX 0.5 mg CHAMPIX 1 mg Film-coated tablets Varenicline
Croatian: CHAMPIX 0,5 mg CHAMPIX 1 mg vareniklin