FrancophonIA/ELRC3.0 huggingface dataset:
English: High-Dose Varenicline vs Placebo Low-Dose Varenicline vs Placebo
Maltese: Varenicline b'Doża Baxxa kontra Plaċebo
English: A large randomised, double-blind, active and placebo-controlled study was conducted to compare the risk of serious neuropsychiatric events in patients with and without a history of psychiatric disorder treated for smoking cessation with varenicline, bupropion, nicotine replacement therapy patch (NRT) or placebo.
Maltese: Studju kbir li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, attiv u kkontrollat mill-plaċebo twettaq sabiex iqabbel ir-riskju ta' avvenimenti newropsikjatriċi serji f'pazjenti li għandhom u li m'għandhomx storja ta' disturbi psikjatriċi kkurati għal twaqqif mit-tipjip b'varenicline, bupropion, gareż ta' terapija ta' sostituzzjoni tan-nikotina (NRT, nicotine replacement therapy) (NRT) jew plaċebo.
English: 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).
Maltese: Varenicline kien evalwat fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, attiv u kkontrollat mill-plaċebo li inkluda individwi bi storja ta' disturbi psikjatriċi (koorti psikjatriku, N=4074) u individwi mingħajr storja ta' disturbi psikjatriċi (koorti mhux psikjatriku, N=3984).
English: AE, adverse event; NRT=Nicotine replacement therapy patch
Maltese: AE, avveniment avvers; NRT= Gareż ta' terapija ta' sostituzzjoni tan-nikotina (NRT, nicotine replacement therapy)
English: 1.52 (1.23, 1.89), P=0.0001
Maltese: 1.52 (1.23, 1.89), P=0.0001 1.51 (1.19, 1.93), P=0.0008
English: 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.
Maltese: Meta varenicline u NRT transdermali ngħataw flimkien lil persuni li jpejpu għal tnax-il ġurnata, kien hemm tnaqqis statistiku sinifikanti fil-pressjoni sistolika medja tad-demm (medja 2.6 mmHg) imkejla fl-aħħar jum ta' l-istudju.
English: Plasma protein binding of varenicline is low (< 20%) and independent of both age and renal function.
Maltese: It-tqabbid ta' varenicline mal-proteini tal-plasma hu baxx (< 20%) u indipendenti kemm mill-eta' kif ukoll mill-funzjoni tal-kliewi.
English: The most common adverse events (≥ 10%) in subjects taking varenicline were nausea (27.0% vs. 10.4% on placebo), headache (16.8% vs. 11.2%), abnormal dreams (11.3% vs. 8.2%), insomnia (10.9% vs. 4.8%) and irritability (10.9% vs. 8.2%).
Maltese: 11.2%), ħolm mhux normali (11.3% vs. 8.2%), nuqqas ta' rqad (10.9% vs. 4.8%) u irritabilità (10.9% vs. 8.2%).
English: Two thousand six hundred nineteen (2619) patients received CHAMPIX 1 mg BID (titrated during the first week), 669 patients received bupropion 150 mg BID (also titrated) and 684 patients received placebo.
Maltese: Elfejn sitt mija u dsatax (2619)-il pazjent irċevew CHAMPIX 1 mg BID (titrati matul l-ewwel ġimgħa), 669 pazjent irċevew bupropion 150 mg BID (ukoll titrati) u 684 pazjent irċevew il-plaċebo.
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
Maltese: Ideat ta' suwiċidju, aggressjoni, reazzjoni ta' paniku, ħsieb mhux normali, irrekwitezza, tibdil fil-burdata, dipressjoni*, ansjeta'*, alluċinazzjonijiet*, żieda fil-libido, tnaqqis fil-libido Psikożi, ħmar il-lejl, attitudni mhux normali, disforja, bradyfrenija Disturbi fis-sistema nervuża Komuni ħafna Uġigħ ta' ras Komuni
English: 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.
Maltese: Dawn il-provi jinkludu l-5 provi deskritti hawn fuq li użaw is-C-SSRS, u total ta' 8521 pazjent (5072 varenicline, 3449 plaċebo), li wħud minnhom kellhom kundizzjonijiet psikjatriċi.
English: Varenicline binds with high affinity and selectivity at the α4β2 neuronal nicotinic acetylcholine receptors, where it acts as a partial agonist - a compound that has both agonist activity, with lower intrinsic efficacy than nicotine, and antagonist activities in the presence of nicotine.
Maltese: Varenicline jaqbad b'affinita' u selettivita' kbira mar-riċevituri nikotiniċi newronali ta' l-aċetilkolina α4β2, fejn jaġixxi bħala agonista parzjali - kompost li għandu kemm attivita' agonista, b'effikaċja intrinsika aktar baxxa min-nikotina, u attivitajiet antagonisti fil-preżenza tan-nikotina.
English: Number assessed Suicidal behaviour and/or ideation Suicidal behaviour Suicidal ideation
Maltese: Waqt il-kura Numru vvalutat Ideat u/jew imġiba suwiċidali Imġiba suwiċidali Ideat suwiċidali
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.
Maltese: Is-sigurtà u t-tollerabilità ta' varenicline kienu evalwati fi studju double-blind f'128 persuna li jpejpu bi skizofrenija stabbli jew b'disturb skizoaffettiv, li qed jieħdu medikazzjoni għal kontra l-psikożi.
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.
Maltese: M'hemmx bżonn aġġustament fid-doża għal pazjenti b'indeboliment tal-kliewi ħafif (clearance stmata tal-kreatinina > 50 ml/min u 80 ml/min) għal moderat (clearance stmata tal-kreatinina 30 ml/min u 50 ml/min).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, fertility and embryo-foetal development.
Maltese: Informazzjoni mhux klinika ma turi l-ebda periklu speċjali għall-bniedem fuq il-bażi ta' studji konvenzjonali ta' sigurta' farmakoloġika, tossiċita' b'dożi ripetuti, ġenotossiċita', fertilita' u żvilupp ta' l-embriju u l-fetu.
English: In a smoking cessation clinical trial, neuropsychiatric adverse events were reported more frequently in patients with a history of psychiatric disorders compared to those without a history of psychiatric disorders, regardless of treatment (see section 5.1).
Maltese: Fi prova klinika tal-waqfien mit-tipjip, avvenimenti avversi newropsikjatriċi kienu rrapportati b'mod aktar frekwenti f'pazjenti bi storja ta' disturbi psikjatriċi meta mqabbla ma' dawk mingħajr storja ta' disturbi psikjatriċi, irrispettivament mill-kura (ara sezzjoni 5.1).
English: Lietuva
Maltese: Lituva
English: Liver function test abnormal
Maltese: Test tal-funzjoni tal-fwied mhux normali
English: The efficacy and safety of varenicline was evaluated in a randomised, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years, who smoked an average of at least 5 cigarettes per day during the 30 days prior to recruitment, and had a score of at least 4 on the Fagerstrom Test for Nicotine Dependence scale.
Maltese: L-effikaċja u s-sigurtà ta' varenicline ġiet ivvalutata fi studju randomizzat, double-blind u kkontrollat bi plaċebo ta' 312-il pazjent li kellhom 12 sa 19-il sena, li pejpu medja ta' mill-inqas 5 sigaretti kuljum matul it-30 jum qabel ir-reklutaġġ, u kellhom punteġġ ta' mill-inqas 4 fuq l-iskala ta' Test Fagerstrom għal Dipendenza fuq in-Nikotina.
English: Some people have reported seizures while taking CHAMPIX.
Maltese: Kien hemm nies li rrapurtaw li kellhom aċċessjonijiet waqt li kienu qed jieħdu CHAMPIX.
English: The most common adverse events in subjects taking varenicline were nausea (23.8% vs. 14.0% on placebo), headache (10.7% vs. 18.6% on placebo) and vomiting (10.7% vs. 9.3% on placebo).
Maltese: 14.0% li qed jieħdu l-plaċebo), uġigħ ta' ras (10.7% vs. 18.6% li qed jieħdu l-plaċebo) u rimettar (10.7% vs. 9.3% li qed jieħdu l-plaċebo).
English: In patients with moderate renal impairment (estimated creatinine clearance  30 ml/min and  50 ml/min), varenicline exposure increased 1.5-fold compared with subjects with normal renal function (estimated creatinine clearance > 80 ml/min).
Maltese: F'pazjenti b'indeboliment tal-kliewi moderat (clearance stmat tal-kreatinina  30 ml/min u  50 ml/min), l-espożizzjoni għal varenicline żdiedet b'darba u nofs meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali (clearance stmata talkreatinina > 80 ml/min).
English: The efficacy of CHAMPIX in smoking cessation is a result of varenicline's partial agonist activity at the α4β2 nicotinic receptor where its binding produces an effect sufficient to alleviate symptoms of craving and withdrawal (agonist activity), while simultaneously resulting in a reduction of the rewarding and reinforcing effects of smoking by preventing nicotine binding to α4β2 receptors (antagonist activity).
Maltese: L-effikaċja ta' CHAMPIX fil-waqfien mit-tipjip hija riżultat ta' l-attivita' agonista pazjali ta' varenicline fir-riċevitur nikotiniku α4β2 fejn it-tqabbid tiegħu jipproduċi effett suffiċjenti biex itaffi s-sintomi tax-xenqa u l-irtirar (attivita' agonista), waqt li fl-istess ħin jirriżulta fi tnaqqis ta' l-effetti gratifikanti u ta' rinforz billi ma jħallix lin-nikotina taqbad mar-riċevituri α4β2 (attivita' antagonista).
English: As a precautionary measure, it is preferable to avoid the use of varenicline during pregnancy (see section 5.1).
Maltese: Bћala prekawzjoni hu preferribbli li ma jintuzax varenicline waqt it-tqala (ara sezzjoni 5.1).
English: 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.
Maltese: Minn 55 pazjent li rrapportaw ħsibijiet jew imġiba suwiċidjali, 48 (24 varenicline, 24 plaċebo) kienu miż-żewġ provi li kienu rreġistraw għalihom pazjenti bi storja ta' skiżofrenja jew disturb skiżoaffettiv, jew ta' dipressjoni.
English: Analyses of clinical trial data did not show evidence of an increased risk of serious neuropsychiatric events with varenicline compared to placebo.
Maltese: Analiżijiet ta' dejta minn provi kliniċi ma wrewx evidenza ta' żieda fir-riskju ta' avvenimenti newropsikjatriċi b'varenicline meta mqabbel ma' plaċebo.
English: The treatment discontinuation rate due to adverse reactions was 11.4% for varenicline compared with 9.7% for placebo.
Maltese: Ir-rata tat-twaqqif tal-kura minħabba reazzjonijiet avversi kienet ta' 11.4% għal varenicline mqabbla ma' 9.7% għall-plaċebo.
English: INFORMATION IN BRAILLE CHAMPIX
Maltese: Jekk tinsa tieħu CHAMPIX
English: * This p value is not considered statistically significant.
Maltese: * Dan il-valur p ma jitqisx statistikament sinifikanti.
English: - Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate).
Maltese: Kull pillola fiha 0.5 mg varenicline (bħala tartrat).
English: 1.74 (1.43, 2.10), P<0.0001
Maltese: 1.74 (1.43, 2.10), P<0.0001 1.62 (1.32, 1.99), P<0.0001
English: CHAMPIX smoking cessation studies have provided data in patients with a history of psychiatric disorders (see section 5.1).
Maltese: Studji dwar il-waqfien mit-tipjip b'CHAMPIX ipprovdew dejta f'pazjenti bi storja ta' disturbi psikjatriċi (ara sezzjoni 5.1).
English: Blisters: Store below 30°C
Maltese: Aħżen f'temperatura taħt 30°C Flixkun:
English: Due to the absence of significant hepatic metabolism, varenicline pharmacokinetics should be unaffected in patients with hepatic impairment (see section 4.2).
Maltese: Minħabba n-nuqqas ta' metaboliżmu epatiku sinifikanti, il-farmakokinetiċi ta' varenicline ma għandhomx jiġu affettwati f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 4.2).
English: Therefore, varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Maltese: Għalhekk, varenicline mhux probabbli li jbiddel il-farmakokinetika ta' komposti li jiġu mmetabolizzati prinċipalment minn enzimi taċ-ċitokromu P450.
English: 1.96 (1.51, 2.54), P<0.0001
Maltese: 1.96 (1.51, 2.54), P<0.0001 1.65 (1.24, 2.20), P=0.0007
English: Keep the package intact
Maltese: Pakkett ta' manteniment
English: 2.30 (1.83, 2.90), P<0.0001
Maltese: 2.30 (1.83, 2.90), P<0.0001 2.00 (1.56, 2.55), P<0.0001
English: 2.99 (2.33, 3.83), P<0.0001
Maltese: 2.99 (2.33, 3.83), P<0.0001 2.50 (1.90, 3.29), P<0.0001
English: Tablets' core
Maltese: Ma fihx pilloli
English: Number of Patients and Risk Ratio for Suicidal Ideation and/or Behaviour Reported on C-SSRS from a Meta-Analysis of 5 Clinical Trials Comparing Varenicline to Placebo:
Maltese: Numru ta' Pazjenti u Proporzjon ta' Riskju għal Ħsibijiet u/jew Imġiba Suwiċidjali Rrapportati fuq C-SSRS minn Meta-Analiżi ta' 5 Ħames Provi Kliniċi Li Jqabblu Varenicline ma' Plaċebo:
English: In patients treated with the recommended dose of 1 mg twice daily following an initial titration period the adverse event most commonly reported was nausea (28.6%).
Maltese: Fil-pazjenti kkurati bid-doża rakkomandata ta' 1mg darbtejn kuljum wara perijodu ta' titrazzjoni inizjali, l-episodju avvers li ġie rrapportat l-aktar kien id-dardir (28.6%).
English: NRT=Nicotine replacement therapy patch
Maltese: NRT= Gareż ta' terapija ta' sostituzzjoni tan-nikotina (NRT, nicotine replacement therapy)
English: Renal elimination of varenicline is primarily through glomerular filtration along with active tubular secretion via the organic cationic transporter, OCT2 (see section 4.5).
Maltese: L-eliminazzjoni ta' varenicline mill-kliewi ssir prinċipalment permezz ta' filtrazzjoni glomerulari flimkien ma' sekrezzjoni tubulari attiva permezz tat-trasportatur katjoniku organiku, OCT2.
English: Chest pain, fatigue
Maltese: Rari tan-nifs, imħat
English: Heart symptoms
Maltese: Sintomi kardjovaskulari
English: Smoking cessation itself may result in changes to warfarin pharmacokinetics (see section 4.4).
Maltese: Il-waqfien mit-tipjip innifsu jista' jwassal għal bidliet fil-farmakokinetiċi ta' warfarin (ara sezzjoni 4.4).
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).
Maltese: Kien hemm ukoll rapporti ta' reazzjonijiet severi tal-ġilda li jinkludu Eritema Multiformi (tip ta' raxx) u s-Sindrome ta' Stevens-Johnson (marda sejra bl-infafet fil-ġilda, fil-ħalq, madwar l-għajnejn jew fil-ġenitali) u reazzjonijiet allerġiċi sejri li jinkludu lanġjoedima (nefħa fil-wiċċ, ħalq jew griżmejn).
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.
Maltese: L-individwi ntgħażlu b'mod każwali fi proporzjon ta' 1:1 għal CHAMPIX 1 mg darbtejn kuljum (N=249) jew plaċebo (N=245) għal 12-il ġimgħa ta' kura u ġew segwiti għal sa 40 ġimgħa wara l-kura.
English: For patients with severe renal impairment (estimated creatinine clearance < 30 ml/min), the recommended dose of CHAMPIX is 1 mg once daily.
Maltese: Għall-pazjenti b'indeboliment akut tal-kliewi (clearance stmata tal-kreatinina < 30 ml/min), id-doża rakkomandata ta' CHAMPIX hi 1 mg darba kuljum.
English: 2.00 (1.54, 2.59), P<0.0001
Maltese: 2.00 (1.54, 2.59), P<0.0001 1.77 (1.33, 2.36), P<0.0001
English: 28 Film-coated tablets 56 Film-coated tablets 112 Film-coated tablets 140 Film-coated tablets
Maltese: 28 pillola miksijin b'rita 56 pillola miksijin b'rita 112 pillola miksijin b'rita 140 pillola miksijin b'rita
English: 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.
Maltese: CHAMPIX ġie evalwat fi studju double-blind, ikkontrollat bi plaċebo li dam 52 ġimgħa, li sar fuq 1,510 individwi li ma kinux kapaċi jew li ma ridux jieqfu jpejpu fi żmien erba' ġimgħat, iżda li riedu gradwalment inaqqsu t-tipjip tagħhom fuq perijodu ta' 12-il ġimgħa qabel ma jieqfu jpejpu għal kollox.
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.
Maltese: 1 x pakkett tal-kartun issiġillat bis-sħana li fih 11 x 0.5 mg u 14 x 1 mg varenicline pilloli miksija b'rita u pakkett folji 1 ta' 28 jew 2 pakketti folji ta' 14 x 1 mg varenicline pilloli miksija b'rita u 2 x pakketti tal-kartun issiġillati bis-sħana li kull wieħed fih 2 pakketti folji ta' 28 jew 4 pakketti folji ta' 14 x 1 mg varenicline pilloli miksija b'rita - tikketta ta' ġewwa u ta' barra.
English: During non-treatment follow up to 52 weeks, the adjudicated events included need for coronary revascularisation (2.0% vs. 0.6%), hospitalisation for angina pectoris (1.7% vs. 1.1%), and new diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure (1.4% vs. 0.6%).
Maltese: Matul l-osservazzjoni sa 52 ġimgħa fejn ma kienx qed jingħata trattament, l-avvenimenti aġġudikati kienu jinkludu ħtieġa għal rivaskularizzazzjoni koronarja (2.0% vs 0.6%), dħul fl-isptar minħabba anġina pectoris (1.7% vs 1.1%), u dijanjosi ġdida ta' mard vaskulari periferali (PVD) jew dħul fl-isptar għal proċedura PVD (1.4% vs 0.6%).
English: 2.26 (1.80, 2.85), P<0.0001
Maltese: 2.26 (1.80, 2.85), P<0.0001 1.87 (1.46, 2.39), P<0.0001
English: Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upperairway cough syndrome, rhinorrhoea Laryngeal pain, snoring
Maltese: Infjammazzjoni tal-parti ta' fuq tal-apparat respiratorju, konġestjoni talapparat respiratorju, disfonja, rinite allerġika, irritazzjoni tal-gerżuma, konġestjoni tas-sinus, sindromu tas-sogħla fil-parti ta' fuq tal-passaġġ
English: Light blue, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 1.0” on the other side.
Maltese: Pilloli ta' lewn ikħal ċar, bikonvessi, forma ta' kapsula, bi “Pfizer” imnaqqxa fuq naħa u “CHX 1.0” fuq in-naħa l-oħra.
English: Treatment initiation packs
Maltese: Mhux applikabbli
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).
Maltese: 3% u 14.3%, rispettivament u s-CA ta' ġimgħa 9-52 kienet 19.8% (varenicline) vs 7.4% (plaċebo).
English: Tablet film coating - CHAMPIX 0.5 mg film-coated tablets Hypromellose
Maltese: Rita tal-pillola -- CHAMPIX 0.5 mg pilloli miksijin b'rita Hypromellose
English: In both cohorts, subjects treated with varenicline demonstrated statistical superiority of CO-confirmed abstinence during weeks 9 through 12 and 9 through 24 compared to subjects treated with bupropion, nicotine patch and placebo (please see table below).
Maltese: Fiż-żewġ koorti, individwi kkurati b'varenicline urew superjorità statistika ta' astinenza kkonfermata mis-CO waqt il-ġimgħat 9 sa 12 u 9 sa 24 meta mqabbla ma' individwi kkurati b'bupropion, gareż tan-nikotina u l-plaċebo (jekk jogħġbok ara t-tabella ta' hawn taħt).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Tagħrif iddettaljat dwar din il-mediċina huwa disponibbli fuq is-sit elettroniku ta' l-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu
English: Tablet film coating - CHAMPIX 1 mg film-coated tablets Hypromellose
Maltese: Rita tal-pillola -- CHAMPIX 1 mg pilloli miksijin b'rita Hypromellose
English: Day 4 - 7
Maltese: Jum 8 - 14
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:
Maltese: Fil-koorti psikjatriku, il-perċentwal ta' individwi b'ideat u/jew imġiba suwiċidali abbażi tal-Iskala talKlassifika tas-Severità tas-Suwiċidju ta' Columbia (C-SSRS) kien simili bejn il-gruppi ta' varenicline u l-plaċebo waqt il-kura u fis-segwitu mhux tal-kura, kif muri fit-tabella li ġejja:
English: White, capsular-shaped, biconvex tablets debossed with “Pfizer” on one side and “CHX 0.5” on the other side.
Maltese: Pilloli bojod bikonvessi forma ta' kapsula bi “Pfizer” imnaqqax fuq naħa u “CHX 0.5” fuq in-naħa loħra.
English: Varenicline N=1026 n (%)
Maltese: N=1026 n (%)
English: There are no clinically meaningful differences in varenicline pharmacokinetics due to age, race, gender, smoking status, or use of concomitant medicinal products, as demonstrated in specific pharmacokinetic studies and in population pharmacokinetic analyses.
Maltese: M'hemmx differenzi klinikament sinifikanti fil-farmakokinetiċi ta' varenicline b'rabta ma' l-eta', irrazza, is-sess tal-persuna, l-abitudni tat-tipjip jew l-użu ta' prodotti mediċinali konkomitanti, kif muri fi studji speċifiċi ta' farmakokinetika u f'analiżi farmakokinetiċi tal-popolazzjoni.
English: Contains Blue Box
Maltese: Fih Kaxxa Blu
English: Renal impairment
Maltese: Rinofarinġite
English: The primary CV endpoint was the time to major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke during treatment.
Maltese: Kardjovaskulari Maġġuri (MACE), definita bħala mewt kardjovaskulari, MI mhux fatali, u puplesija mhux fatali.
English: In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).
Maltese: F'pazjenti li kienu fl-aħħar stadju talmard tal-kliewi (ESRD), varenicline ġie mneħħi b'mod effiċjenti permezz ta' ħemodijaliżi (ara sezzjoni 4.2).
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
Maltese: Pakkett tal-kartun li fih jew 2 folji ta' 14 x 1 mg varenicline pilloli miksijin b'rita jew 4 folji ta' 14 x 1 mg varenicline pilloli miksijin b'rita jew 8 folji ta' 14 x 1 mg varenicline pilloli miksijin b'rita jew 10 folji ta' 14 x 1 mg varenicline pilloli miksijin b'rita
English: Varenicline N=990 n (%)
Maltese: N=990 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.
Maltese: - Pakketti ta' kontinwazzjoni (manteniment) li fihom 2, 4, 8 jew 10 folji trasparenti ta' 14 x CHAMPIX 1 mg pilloli miksijin b'rita f'kaxxa.
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”
Maltese: - CHAMPIX 0.5 mg pilloli miksijin b'rita huma pilloli bojod, miksijin b'rita, forma ta' kapsula mmodifikata, immarkat “Pfizer” u “CHX 0.5”