natgillin/translations-raw huggingface dataset:
Other medicines and CHAMPIX
Druga zdravila in zdravilo CHAMPIX
This meta-analysis included one trial (N=127) in patients with a history of schizophrenia or schizoaffective disorder and another trial (N=525) in patients with a history of depression.
Ta meta analiza je vključevala eno preskušanje (n = 127) pri bolnikih s shizofrenijo ali shizoafektivno motnjo v anamnezi ter eno preskušanje (n = 525) pri bolnikih z depresijo v anamnezi.
Comparative clinical studies
Primerjalni klinični študiji
Because elderly patients are more likely to have decreased renal function, prescribers should consider the renal status of an elderly patient.
Ker je pri starejših bolnikih večja verjetnost za zmanjšano delovanje ledvic, je treba pri starejših bolnikih upoštevati stanje ledvic.
CHAMPIX should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Zdravilo CHAMPIX je treba uporabljati previdno pri bolnikih z anamnezo epileptičnih napadov ali drugih stanj, ki lahko znižajo prag za epileptične napade.
You are more likely to stop smoking if you are motivated to stop.
Verjetnost, da boste kajenje res opustili, je večja, če ste za opustitev motivirani.
Of the 55 patients who reported suicidal ideation or behaviour, 48 (24 varenicline, 24 placebo) were from the two trials that enrolled patients with a history of schizophrenia/ schizoaffective disorder, or of depression.
Od 55 bolnikov, pri katerih so poročali o samomorilnih mislih ali vedenju, jih je bilo 48 (24 vareniklin, 24 placebo) iz dveh preskušanj, ki sta vključevali bolnike s shizofrenijo/shizoafektivno motnjo ali depresijo v anamnezi.
Patients included in this study had taken CHAMPIX for a smoking-cessation attempt in the past (for a total treatment duration of a minimum of two weeks), at least three months prior to study entry, and had been smoking for at least four weeks.
Bolniki, vključeni v to študijo, so v preteklosti jemali zdravilo CHAMPIX za opustitev kajenja (s skupnim trajanjem zdravljenja vsaj dva tedna) vsaj tri mesece pred vključitvijo v študijo in so kadili vsaj štiri tedne.
Weight increased, decreased appetite, increased appetite
• povečanje telesne mase, zmanjšan apetit, povečan apetit
Plasma protein binding of varenicline is low (< 20%) and independent of both age and renal function.
Vezava vareniklina na beljakovine v plazmi je nizka (≤ 20 %) in ni odvisna od starosti in delovanja ledvic.
Contains Blue Box
Vsebuje modro okence
Care should be taken with patients with a history of psychiatric illness and patients should be advised accordingly.
Pri bolnikih z anamnezo psihiatrične bolezni je potrebna previdnost, bolnikom pa je treba ustrezno svetovati.
The occurrence of detected suicide was rare during the three months after patients initiated any drug treatment (two cases in 31,260 varenicline users and six cases in 81,545 NRT users).
V obdobju treh mesecev po začetku zdravljenja s katerimkoli zdravilom je bila pojavnost ugotovljenega samomora redka (dva primera pri 31.260 uporabnikih vareniklina in šest primerov pri 81.545 uporabnikih NRT).
Physiological changes resulting from smoking cessation, with or without treatment with CHAMPIX, may alter the pharmacokinetics or pharmacodynamics of some medicinal products, for which dosage adjustment may be necessary (examples include theophylline, warfarin and insulin).
Fiziološke spremembe, do katerih pride zaradi prenehanja kajenja, z zdravljenjem z zdravilom CHAMPIX ali brez njega, lahko spremenijo farmakokinetiko ali farmakodinamiko nekaterih zdravil, za katera bo morda potrebna prilagoditev odmerka (med takšnimi zdravili so teofilin, varfarin in insulin).
CA was defined as the proportion of all subjects treated who did not smoke (not even a puff of a cigarette) from Week 9 through Week 52 and did not have an exhaled CO measurement of > 10 ppm.
Delež CA je bil opredeljen kot odstotek vseh zdravljenih oseb, ki od 9. do vključno 52. tedna niso kadile (niti vdiha cigarete) in jim v izdihanem zraku niso izmerili > 10 ppm CO.
Tell your doctor if you have experienced seizures or have epilepsy before your start CHAMPIX treatment.
Obvestite zdravnika, če ste doživeli epileptične napade ali imate epilepsijo, preden pričnete zdravljenje z zdravilom CHAMPIX.
28 Film-coated tablets 56 Film-coated tablets 112 Film-coated tablets 140 Film-coated tablets
28 filmsko obloženih tablet 56 filmsko obloženih tablet 112 filmsko obloženih tablet 140 filmsko obloženih tablet
Your doctor may decide to gradually lower your dose of CHAMPIX at the end of treatment.
Zdravnik se bo morda odločil, da vam bo proti koncu zdravljenja odmerek zdravila postopoma zmanjševal.
Patients should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period.
Bolniki morajo v prvih 12 tednih zdravljenja zmanjšati kajenje in ga popolnoma opustiti do konca tega obdobja zdravljenja.
Pooled data from these 18 trials showed a similar incidence rate of individual categories of psychiatric events in patients treated with varenicline compared to patients treated with placebo.
Združeni podatki iz teh 18 preskušanj so pokazali podoben delež pojavnosti posameznih kategorij psihiatričnih dogodkov pri bolnikih, zdravljenih z vareniklinom, v primerjavi z bolniki, zdravljenimi s placebom.
Animal studies suggest that varenicline is excreted in breast milk.
Študije na živalih kažejo, da se vareniklin izloča v materino mleko.
No attempt has been made in either the design or the analysis of the CHAMPIX studies to distinguish between adverse reactions associated with study drug treatment or those possibly associated with nicotine withdrawal.
Nobenega poskusa ni bilo, da bi pri načrtovanju ali analizi študij zdravila CHAMPIX razlikovali med neželenimi učinki, povezanimi s proučevanim zdravilom, in neželenimi učinki, povezanimi z odtegnitvijo nikotina.
For some people, stopping smoking with or without treatment has been associated with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety and can be associated with a worsening of psychiatric disorder.
Pri nekaterih ljudeh je opustitev kajenja, z uporabo zdravil ali brez nje, povezana z večjim tveganjem za pojav sprememb v mišljenju ali vedenju, občutek depresije in tesnobnosti, in je lahko povezana s poslabšanjem psihiatrične motnje.
Varenicline undergoes minimal metabolism with 92% excreted unchanged in the urine and less than 10% excreted as metabolites.
Vareniklin se minimalno presnavlja; 92 % se ga nespremenjenega izloči v urin in manj kot 10 % se ga izloči v obliki presnovkov.
If you have a history of psychiatric disorder you should discuss this with your doctor.
Če ste kdaj imeli psihiatrično motnjo, se o tem posvetujte z zdravnikom.
Patients taking CHAMPIX should be instructed to notify their doctor of new or worsening cardiovascular symptoms and to seek immediate medical attention if they experience signs and symptoms of myocardial infarction or stroke (see section 5.1).
Bolnikom, ki jemljejo zdravilo CHAMPIX, je treba naročiti, naj svojega zdravnika obvestijo o pojavu novih ali poslabšanju obstoječih srčnožilnih simptomov in da naj ob znakih in simptomih miokardnega infarkta ali možganske kapi nemudoma poiščejo zdravniško pomoč (glejte poglavje 5.1).
In the majority of cases nausea occurred early in the treatment period, was mild to moderate in severity and seldom resulted in discontinuation.
Večinoma se je navzea pojavila zgodaj v obdobju zdravljenja, bila je blaga do zmerno huda in je redko povzročila prekinitev zdravljenja.
Heart symptoms
Srčni simptomi
After the initial 12-week reduction phase, subjects continued treatment for another 12 weeks.
Po začetnem 12-tedenskem obdobju zmanjševanja so preskušanci nadaljevali z zdravljenjem še dodatnih 12 tednov.
When varenicline and transdermal NRT were co-administered to smokers for 12 days, there was a statistically significant decrease in average systolic blood pressure (mean 2.6 mmHg) measured on the final day of the study.
Ko so kadilcem 12 dni sočasno dajali vareniklin in transdermalno NRT, so ugotovili statistično pomembno znižanje povprečnega sistoličnega krvnega tlaka (povprečno 2,6 mmHg), izmerjenega zadnji dan študije.
Should you experience adverse effects that you cannot tolerate your doctor may decide to reduce your dose temporarily or permanently to 0.5 mg twice daily.
Če se pri vas pojavijo neželeni učinki, ki jih ne morete prenašati, se bo zdravnik morda odločil za začasno ali stalno zmanjšanje odmerka na 0,5 mg dvakrat na dan.
The following table from the above paediatric study shows a comparison of continuous abstinence rates (CAR) from weeks 9-12, confirmed by urine cotinine test, for the full analysis set overall study population and the 12-17 year old population.
Naslednja preglednica iz omenjene pediatrične študije prikazuje primerjavo deležev trajne abstinence (CAR - Continuous Abstinence Rate) v 9. do 12. tednu, ki so jo potrdili z urinskim kotininskim testom pri celotnem naboru za analizo celokupne populacije v študiji in pri populaciji, stari od 12 do 17 let.
The following table shows the incidence of MACE and Hazard Ratios vs placebo for all treatment groups during treatment, and cumulative for treatment plus 30 days and through end of study.
Naslednja preglednica prikazuje pojavnost MACE in razmerja ogroženosti v primerjavi s placebom za vse zdravljene skupine za obdobje med zdravljenjem, obdobje zdravljenja in dodatnih 30 dni ter do konca študije.
No dosage adjustment of CHAMPIX or co-administered medicinal products listed below is recommended.
Prilagoditev odmerka zdravila CHAMPIX ali spodaj navedenih sočasno uporabljanih zdravil ni potrebna.
If you have severe kidney disease you should avoid taking cimetidine (a medicine used for gastric problems) at the same time as CHAMPIX as this may cause increased blood levels of CHAMPIX.
Če imate hudo ledvično bolezen, ne smete hkrati z zdravilom CHAMPIX jemati cimetidina (zdravila za zdravljenje želodčnih težav), ker lahko privede do povečanih vrednosti zdravila CHAMPIX v krvi.
CHAMPIX dosing should usually start 1-2 weeks before this date (see section 5.1).
Zdravilo CHAMPIX naj običajno začne uporabljati 1 do 2 tedna pred tem datumom (glejte poglavje 5.1).
The table below describes the most frequently (≥ 1%) reported categories of adverse events related to psychiatric safety other than sleep disorders and disturbances.
Spodnja preglednica prikazuje najpogosteje (≥ 1 %) poročane kategorije neželenih učinkov, povezane s psihiatrično varnostjo, ki ne vključujejo motenj spanja.
There are no clinical data on the effects of varenicline on fertility.
Na voljo ni kliničnih podatkov o vplivih vareniklina na plodnost.
Patients who are not willing or able to set the target quit date within 1-2 weeks, could be offered to start treatment and then choose their own quit date within 5 weeks.
Bolnikom, ki ne želijo ali niso zmožni postaviti ciljnega datuma opustitve kajenja v 1-2 tednih, je mogoče ponuditi, da z zdravljenjem začnejo, nato pa izberejo svoj lasten datum opustitve kajenja v 5 tednih.
A meta-analysis of 15 clinical trials of ≥ 12 weeks treatment duration, including 7002 patients (4190 CHAMPIX, 2812 placebo), was conducted to systematically assess the cardiovascular safety of CHAMPIX.
Meta analiza 15 kliničnih preskušanj, pri katerih je zdravljenje trajalo ≥ 12 tednov, v njih pa sta bila vključena 7.002 bolnika (4.190 CHAMPIX, 2.812 placebo), je bila opravljena z namenom sistematične ocene srčnožilne varnosti zdravila CHAMPIX.
Varenicline is highly selective and binds more potently to the α4β2 receptor subtype (Ki=0.15 nM) than to other common nicotinic receptors (α3β4 Ki=84 nM, α7 Ki= 620 nM, α1βγδ Ki= 3,400 nM), or to non-nicotinic receptors and transporters (Ki > 1µM, except to 5-HT3 receptors: Ki=350 nM).
Vareniklin je močno selektiven in se na podvrsto receptorjev α4β2 veže močneje (Ki = 0,15 nM) kot na druge pogoste nikotinske receptorje (α3β4 Ki = 84 nM, α7 Ki = 620 nM, α1βγδ Ki = 3,400 nM) ali na nenikotinske receptorje in transporterje (Ki > 1 μM, razen na receptorje 5-HT3: Ki = 350 nM).
This leaflet was last revised in
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}>
CHAMPIX was evaluated in a randomised, double-blind, placebo-controlled study of subjects with stable, cardiovascular disease (other than, or in addition to, hypertension) that had been diagnosed for more than 2 months.
Zdravilo CHAMPIX je bilo ovrednoteno v randomizirani, dvojno slepi, s placebom nadzorovani študiji pri bolnikih s stabilno srčnožilno boleznijo (ki ni bila hipertenzija ali je spremljala hipertenzijo), ki je bila diagnosticirana več kot 2 meseca.
• Obligation to conduct post-authorisation measures Not Applicable.
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
For elderly patients with reduced renal function please refer to section 4.2.
Za starejše bolnike z zmanjšanim delovanjem ledvic glejte poglavje 4.2.
A moderate amount of data on pregnant women indicated no malformative or foetal/neonatal toxicity of varenicline (see section 5.1).
Manjše število podatkov o uporabi pri nosečnicah ni pokazalo malformacijske ali feto-/neonatalne toksičnosti vareniklina (glejte poglavje 5.1).
There is currently limited clinical experience with the use of CHAMPIX among black people to determine clinical efficacy.
Trenutno je le malo kliničnih izkušenj z uporabo zdravila CHAMPIX z namenom določitve klinične učinkovitosti pri temnopoltih ljudeh.
Nicotine replacement therapy (NRT)
Nadomestno zdravljenje z nikotinom (NRT)
The prespecified statistical testing procedures stopped testing after the high-dose varenicline vs Placebo treatment comparison in the overall study did not achieve statistical significance.
Predhodno opredeljene postopke statistične analize so prekinili po tem, ko primerjava velikega odmerka vareniklina in placeba v celokupni študiji ni dosegla statistične pomembnosti.
Days 4 - 7:
4. do 7. dan:
These trials included the 5 trials described above that used the C-SSRS, and a total of 8521 patients (5072 varenicline, 3449 placebo), some of which had psychiatric conditions.
Ta preskušanja so vključevala 5 zgoraj opisanih preskušanj, kjer so uporabili lestvico C-SSRS, in skupno 8.521 bolnikov (5.072 vareniklin, 3.449 placebo), od katerih so imeli nekateri psihiatrična stanja.
Does not contain a tablet
Ne vsebuje tablet.
Bottles: 2 years
Plastenke: 2 leti.
CHAMPIX was evaluated in a 52-week double-blind placebo-controlled study of 1,510 subjects who were not able or willing to quit smoking within four weeks, but were willing to gradually reduce their smoking over a 12 week period before quitting.
Zdravilo CHAMPIX so ocenili v 52-tedenski dvojno slepi, s placebom nadzorovani študiji pri 1.510 preskušancih, ki kajenja niso bili sposobni ali pripravljeni opustiti v štirih tednih, vendar so bili pripravljeni postopno zmanjšati kajenje v obdobju 12 tednov pred prenehanjem.
The pharmacokinetics of varenicline in elderly patients with normal renal function (aged 65-75 years) is similar to that of younger adult subjects (see section 4.2).
Farmakokinetika vareniklina je pri starejših bolnikih z normalnim delovanjem ledvic (starih od 65 do 75 let) podobna kot pri mlajših odraslih osebah (glejte poglavje 4.2).
It is unknown whether varenicline is excreted in human breast milk.
Ni znano, ali se vareniklin pri človeku izloča v materino mleko.
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Giving up smoking with or without treatment can cause various symptoms.
Prenehanje kajenja, z zdravljenjem ali brez njega, lahko povzroči razne simptome.
Difference (95% CI)
razlika (95 % IZ)
Patients received treatment for 12 weeks, followed by a non-treatment period of 40 weeks, along with age-appropriate counseling throughout the study.
Bolniki so zdravilo prejemali 12 tednov, čemur je sledilo 40 tednov dolgo obdobje brez zdravila, skupaj s starosti primernim svetovanjem v celotnem času študije.
There was one completed suicide, which occurred during treatment in a subject treated with placebo in the non-psychiatric cohort.
Zabeležili so en samomor, ki ga je med zdravljenjem storil preskušanec, ki je prejemal placebo v nepsihiatrični kohorti.
The recommended dose is 1 mg varenicline twice daily following a 1-week titration as follows: Days 1 - 3:
Priporočeni odmerek je 1 mg vareniklina dvakrat na dan, in sicer po naslednji 1-tedenski titraciji:
Tell your doctor if you have any changes in symptoms during treatment with CHAMPIX.
Obvestite zdravnika, če se vam simptomi med zdravljenjem z zdravilom CHAMPIX spremenijo.
There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking CHAMPIX.
Poročali so o depresiji, samomorilnih mislih in vedenju ter poskusih samomora pri bolnikih, ki so jemali zdravilo CHAMPIX.
The results showed no increase in the incidence of suicidal ideation and/or behaviour in patients treated with varenicline compared to patients treated with placebo, as shown in the table below.
Rezultati niso pokazali povečanja pojavnosti samomorilnih misli in/ali vedenja pri bolnikih, zdravljenih z vareniklinom, v primerjavi z bolniki, zdravljenimi s placebom, kot je prikazano v spodnji preglednici.
If you are not able or willing to quit smoking straight away, you should reduce smoking during the first 12 weeks of treatment and quit by the end of that treatment period.
Če kajenja niste sposobni ali pripravljeni opustiti nenadoma, boste morali v prvih 12 tednih zdravljenja zmanjšati kajenje in ga popolnoma opustiti do konca tega obdobja zdravljenja.
In vitro studies demonstrate that varenicline does not inhibit cytochrome P450 enzymes (IC50 > 6,400 ng/ml).
Študije in vitro kažejo, da vareniklin ne zavira encimov citokroma P450 (IK50 > 6.400 ng/ml).
Deaths and serious cardiovascular events were adjudicated by a blinded, committee.
Smrti in resne srčnožilne dogodke je pregledal neodvisni odbor.
Overall n/N (%)
celokupna populacija n/N (%)
Furthermore since metabolism of varenicline represents less than 10% of its clearance, active substances known to affect the cytochrome P450 system are unlikely to alter the pharmacokinetics of varenicline (see section 5.2) and therefore a dose adjustment of CHAMPIX would not be required.
Poleg tega presnova vareniklina predstavlja manj kot 10 % njegovega očistka, zato ni verjetno, da bi farmakokinetiko vareniklina spremenile učinkovine, ki vplivajo na sistem citokroma P450 (glejte poglavje 5.2); prilagoditev odmerka zdravila CHAMPIX torej ni potrebna.
CHAMPIX may cause dizziness, somnolence and transient loss of consciousness, and therefore may influence the ability to drive and use machines.
Zdravilo Champix lahko povzroči omotico, zaspanost in prehodno izgubo zavesti ter lahko tako vpliva na sposobnost vožnje in upravljanja strojev.
Atrial fibrillation, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased
Redki atrijska fibrilacija, znižanje segmenta ST v elektrokardiogramu, zmanjšanje amplitude vala T v elektrokardiogramu
Subjects who experienced an adverse event of a concern during previous treatment were excluded.
Preskušanci, pri katerih se je med predhodnim zdravljenjem pojavil resen neželeni učinek, so bili izključeni.
In the table below all adverse reactions, which occurred at an incidence greater than placebo are listed by system organ class and frequency (very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000)).
Vsi neželeni učinki, ki so se pojavili z večjo pojavnostjo kot pri placebu, so v spodnji preglednici navedeni po organskem sistemu in pogostnosti (zelo pogosti (≥ 1/10), pogosti (≥ 1/100, < 1/10), občasni (≥ 1/1.000, < 1/100) in redki (≥ 1/10.000, < 1/1.000)).
Smoking cessation, with or without pharmacotherapy, has been associated with exacerbation of underlying psychiatric illness (e.g. depression).
Prenehanje kajenja, z zdravljenjem ali brez njega, povezujejo s poslabšanjem že obstoječih psihiatričnih bolezni (npr. depresije).
If you are taking CHAMPIX and develop agitation, depressed mood, changes in behaviour that are of concern to you or your family or if you develop suicidal thoughts or behaviours you should stop taking CHAMPIX and contact your doctor immediately for treatment assessment.
Če jemljete zdravilo CHAMPIX in se pojavijo razdražljivost, depresivno razpoloženje, spremembe v vedenju, ki bi lahko vzbujale skrb vam ali vaši družini, ali če se pojavijo samomorilne misli ali vedenje, prenehajte jemati zdravilo CHAMPIX in se nemudoma posvetujte z zdravnikom, da bo ocenil zdravljenje.
A population-based cohort study compared infants exposed to CHAMPIX in utero (N=335) with infants born to mothers who smoked during pregnancy (N=78,412) and infants born to non-smoking mothers (N=806,438).
V populacijski kohortni študiji so primerjali dojenčke, ki so bili zdravilu CHAMPIX izpostavljeni in utero (n = 335), z dojenčki, rojenimi materam, ki so med nosečnostjo kadile (n = 78.412), in dojenčki, rojenimi materam nekadilkam (n = 806.438).
At the end of treatment, discontinuation of CHAMPIX was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients.
Na koncu zdravljenja je bila prekinitev jemanja zdravila CHAMPIX pri do 3 % bolnikov povezana s povečano razdražljivostjo, slo po kajenju, depresijo in/ali nespečnostjo.
You should then continue to take CHAMPIX 1 mg film-coated tablets twice daily for a further 12 weeks resulting in a total of 24 weeks of treatment.
Nato boste morali jemati filmsko obložene tablete CHAMPIX 1 mg dvakrat na dan še nadaljnjih 12 tednov, tako da bo skupno trajanje zdravljenja 24 tednov.
Co-administration of cimetidine, with varenicline increased the systemic exposure of varenicline by 29% due to a reduction in varenicline renal clearance.
Sočasna uporaba cimetidina z vareniklinom je zaradi zmanjšanja ledvičnega očistka vareniklina povečala sistemsko izpostavljenost vareniklinu za 29 %.
The rates of events in the composite endpoint were low across all treatment groups and were similar or lower for each of the active treatments compared to placebo.
Deleži sestavljenega opazovanega dogodka so bili majhni v vseh zdravljenih skupinah in so bili podobni ali manjši za vsako zdravljenje z učinkovino v primerjavi s placebom.
Of all subjects treated in the parent study, 1749 (21.7%) had a medium CV risk and 644 (8.0%) had a high CV risk, as defined by Framingham score.
Od vseh preskušancev, zdravljenih v matični študiji, jih je 1.749 (21,7 %) imelo zmerno srčnožilno tveganje, 644 (8,0 %) pa veliko srčnožilno tveganje, določeno po Framinghamski lestvici.
Based on post marketing reports, bupropion may be associated with neuropsychiatric adverse events.
Poročila iz obdobja trženja kažejo, da je lahko bupropion povezan z nevropsihiatričnimi neželenimi učinki.
In the varenicline group compared to placebo, a higher proportion of subjects reported suicidal ideation or behaviour prior to enrolment (lifetime history) and after the end of active treatment period (on Days 33 to 85 after the last dose of treatment).
V skupini, ki je prejemala vareniklin, je v primerjavi s skupino, ki je prejemala placebo, več preskušancev poročalo o razmišljanju o samomoru ali samomorilnem vedenju pred vključitvijo v študijo (osebna anamneza) ter po koncu obdobja, v katerem so prejemali zdravilo (na 33. do 85. dan po zadnjem prejetem odmerku zdravila).
12-week Treatment Initiation Pack containing:
12-tedensko začetno pakiranje (začetek zdravljenja) Ena zunanja škatla, ki vsebuje: