FrancophonIA/ELRC3.0 huggingface dataset:
English: Varenicline did not alter the pharmacokinetics of warfarin.
Maltese: Varenicline ma bidilx il-farmakokinetiċi ta' warfarin.
English: 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.
Maltese: Mill-pazjenti kollha kkurati fl-istudju prinċipali, 1749 (21.7 %) kellhom riskju CV medju u 644 (8.0 %) kellhom riskju CV għoli, kif definit mill-punteġġ ta' Framingham.
English: Pollakiuria, nocturia
Maltese: Pollakijurja, notturja
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome and Erythema Multiforme) have been reported with the use of CHAMPIX.
Maltese: Raxxijiet fil-ġilda potenzjalment fatali (sindrome ta' Stevens-Johnson u Eritema multiformi) kienu rrappurtati bl-użu ta' Champix.
English: 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)).
Maltese: Ir-reazzjonijiet avversi kollha fit-tabella ta' hawn taħt, li seħħew b'inċidenza akbar mill-plaċebo huma elenkati bis-sistema tal-klassifika ta' l-organi u l-frekwenza (≥1/10), komuni (≥1/100 to <1/10), mhux komuni (≥1/1,000 to <1/100) u rari (≥1/10,000 to <1/1,000)).
English: Week 1 Week 2-4
Maltese: Ġimgħa 1 Ġimgħa 2-4
English: The primary safety endpoint was a composite of the following neuropsychiatric (NPS) adverse events: severe events of anxiety, depression, feeling abnormal, or hostility, and/or moderate or severe events of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behaviour or completed suicide.
Maltese: Il-punt tat-tmiem primarju ta' sigurtà kien kompost mill-avvenimenti avversi newropsikjatriċi (NPS) li ġejjin: avvenimenti severi ta' ansjetà, depressjoni, sensazzjoni anormali, jew ostilità, u/jew avvenimenti moderati jew severi ta' aġitazzjoni, aggressjoni, delużjonijiet, alluċinazzjonijiet, ideat ta' omiċidju, manija, paranojja, psikożi, ideat suwiċidali, imġiba suwiċidali jew twettiq ta' suwiċidju.
English: What CHAMPIX contains - The active substance is varenicline.
Maltese: - Is-sustanza attiva hi varenicline.
English: It is preferable to avoid the use of CHAMPIX while you are pregnant.
Maltese: Hu preferribbli li jiġi evitat l-użu ta' CHAMPIX meta tkun tqila.
English: CHAMPIX is available in the following pack presentations:
Maltese: CHAMPIX hu disponibbli fil-pakketti li ġejjin:
English: 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).
Maltese: Varenicline hu selettiv ħafna u jaqbad b'mod aktar b'saħħtu mas-sottotip tarriċettur α4β2 (Ki=0.15 nM) milli ma' riċevituri nikotiniċi oħra komuni (α3β4 Ki=84 nM, α7 Ki= 620 nM, α1βγδ Ki= 3,400 nM), jew ma' riċevituri u trasportaturi mhux nikotiniċi (Ki > 1μM, ħlief għarriċevituri 5-HT3: Ki=350 nM).
English: Pharmacotherapeutic group: Other nervous system drugs; Drugs used in addictive disorders; Drugs used in nicotine dependence, ATC code: N07BA03
Maltese: Mediċini oħra li jaħdmu fuq is-sistema nervuża;Mediċini użati f'disturbi vizzjużi; Mediċini użati fid-dipendenza fuq in-nikotina, Kodiċi ATC: N07BA03
English: Varenicline did not alter the steady-state pharmacokinetics of digoxin.
Maltese: Varenicline ma bidilx il-farmakokinetiċi fissi ta' digoxin.
English: Bronchitis, sinusitis
Maltese: Bronkite, sinożite
English: Date of latest renewal: 29 June 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 26 ta' Settembru 2006 Data tal-aħħar tiġdid: 29 ta' Ġunju 2016
English: Film-coated tablet of 4 mm x 8 mm
Maltese: Pillola miksija b'rita ta' 4 mm x 8 mm
English: Apparent volume of distribution averaged 415 litres (%CV= 50) at steady-state.
Maltese: Il-volum apparenti tad-distribuzzjoni kien bħala medja 415-il litru (%CV=50) fl-istat stabbli.
English: 12-to-17-Year Olds n/N (%)
Maltese: 12 sa 17-il Sena n/N (%)
English: CHAMPIX comes as a white tablet (0.5 mg) and a light blue tablet (1 mg).
Maltese: CHAMPIX jiġu f'pillola bajda (0.5 mg) u pillola blu ċara (1 mg).
English: Treatment Comparisons: Odds ratio (95% CI), p value Varenicline vs Placebo
Maltese: Tqabbil bejn kura u oħra: Proporzjon ta' probabbiltà (95% CI), valur p Varenicline vs Plaċebo
English: 0.5 mg
Maltese: 0.5 mg 1 mg
English: Seizure, tremor, lethargy, hypoaesthesia
Maltese: Aċċessjoni, tregħid, letarġija, ipoestesija
English: A meta-analysis of 5 randomised, double-blind, placebo controlled trials, including 1907 patients (1130 varenicline, 777 placebo), was conducted to assess suicidal ideation and behaviour as reported on the Columbia-Suicide Severity Rating Scale (C-SSRS).
Maltese: Twettqet meta-analiżi ta' 5 provi kkontrollati bi plaċebo, double blind, randomizzati, li jinkludu 1907 pazjenti (1130 varenicline, 777 plaċebo), biex jiġu vvalutati l-ħsibijiet u l-imġiba suwiċidjali kif irrapportat fuq l-Iskala ta' Klassifikazzjoni tas-Severità tas-Suwiċidji ta' Columbia (Columbia-Suicide Severity Rating Scale - C-SSRS).
English: Varenicline vs Bupropion 1.49 (1.20, 1.85), P=0.0003
Maltese: Varenicline vs Bupropion 1.49 (1.20, 1.85), P=0.0003 1.41 (1.11, 1.79), P=0.0047 Varenicline vs NRT
English: Diabetes mellitus, polydipsia Psychiatric disorders
Maltese: Dijabete mellitus, polydipsia
English: Varenicline undergoes minimal metabolism with 92% excreted unchanged in the urine and less than 10% excreted as metabolites.
Maltese: Varenicline jiġi sottopost għal metaboliżmu minimu bi 92% tad-doża jitneħħa mhux modifikat flawrina u anqas minn 10% jitneħħa bħala metaboliti.
English: CA = continuous abstinence rate; CI = confidence interval; NRT=Nicotine replacement therapy patch
Maltese: CA = rata kontinwa ta' astinenza; CI = intervall ta' kunfidenza; NRT= Gareż ta' terapija ta' sostituzzjoni tan-nikotina (NRT, nicotine replacement therapy)
English: As smoking induces CYP1A2, smoking cessation may result in an increase of plasma levels of CYP1A2 substrates.
Maltese: Billi t-tipjip jinduċi CYP1A2, waqfien mit-tipjip jista' jirriżulta f'żieda fil-livelli tas-sottostrati ta' CYP1A2 filplasma.
English: Film-coated tablet of 5 mm x 10 mm
Maltese: Pillola miksija b'rita ta' 5 mm x 10 mm
English: CHAMPIX 1 mg film-coated tablets are light blue film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 1.0”
Maltese: - CHAMPIX 1 mg pilloli miksijin b'rita huma pilloli blu ċari, miksijin b'rita, forma ta' kapsula modifikata, immarkati “Pfizer” u “CHX 1.0”
English: 154 x 1 mg film-coated tablets
Maltese: 154 x 1 mg pilloli miksija b'rita
English: n (%)
Maltese: Globalin/N (%)
English: NRT N=1006 n (%)
Maltese: N=1006 n (%)
English: For elderly patients with reduced renal function please refer to section 4.2.
Maltese: Għal pazjenti anzjani b'funzjoni tal-kliewi mnaqqsa jekk jogħġbok irreferi għal sezzjoni 4.2.
English: Varenicline pharmacokinetics were unchanged in subjects with mild renal impairment (estimated creatinine clearance > 50 ml/min and  80 ml/min).
Maltese: Il-farmakokinetika ta' varenicline ma kinux modifikati f'pazjenti b'indeboliment ħafif tal-kliewi (clearance stmata tal-kreatinina > 50 ml/min u 80 ml/min).
English: There have also been post-marketing reports of rare but severe cutaneous reactions, including StevensJohnson Syndrome and Erythema Multiforme in patients using varenicline.
Maltese: Kien hemm ukoll rapporti ta' wara t-tqegħid fis-suq ta' reazzjonijiet rari imma severi tal-ġilda, li jinkludu sindromu Stevens-Johnson Syndrome u Erythema Multiforme f'pazjenti li wżaw varenicline.
English: Subjects aged 18-75 years, smoking 10 or more cigarettes per day were randomised 1:1:1:1 to varenicline 1 mg BID, bupropion SR 150 mg BID, nicotine replacement therapy patch (NRT) 21 mg/day with taper or placebo for a treatment period of 12 weeks; they were then followed for another 12 weeks post-treatment.
Maltese: Individwi fl-età ta' 18-75 sena, li jpejpu 10 sigaretti jew aktar kuljum intgħażlu b'mod każwali 1:1:1:1 għal varenicline 1 mg BID, bupropion SR 150 mg BID, gareż ta' terapija ta' sostituzzjoni tan-nikotina (NRT, nicotine replacement therapy) (NRT) 21 mg/jum bi tnaqqis għaxxejn jew plaċebo għal perjodu ta' kura ta' 12-il ġimgħa; dawn imbagħad kienu segwiti għal 12-il ġimgħa oħra wara l-kura.
English: Also, in human hepatocytes in vitro, varenicline was shown to not induce the activity of cytochrome P450 enzymes 1A2 and 3A4.
Maltese: Barra minn hekk, fl-epatoċiti umani in vitro, varenicline ġie muri li ma jinduċix l-attivita' ta' l-enzimi 1A2 u 3A4 taċ-ċitokromu P450.
English: CHAMPIX 0.5 mg CHAMPIX 1 mg Film-coated tablets Varenicline
Maltese: CHAMPIX 0.5 mg CHAMPIX 1 mg Varenicline
English: In subjects with severe renal impairment (estimated creatinine clearance < 30 ml/min), varenicline exposure was increased 2.1-fold.
Maltese: F'pazjenti b'indeboliment sever tal-kliewi (clearance stmata tal-kreatinina < 30 ml/min), l-espożizzjoni għal varenicline żdiedet bi 2.1 drabi.
English: Overall, a small number of MACE occurred during treatment in the trials included in the meta-analysis (CHAMPIX 7 [0.17%]; placebo 2 [0.07%]).
Maltese: Ġeneralment, kien hemm numru żgħir ta' MACE fil-provi inklużi fil-meta-analiżi (CHAMPIX 7 [0.17%]).
English: 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).
Maltese: Studju koorti bbażat fuq il-popolazzjoni qabbel trabi esposti għal CHAMPIX in utero (N=335) ma' trabi mwielda minn ommijiet li pejpu waqt it-tqala (N=78,412) u trabi mwielda minn ommijiet li ma jpejpux (N=806,438).
English: The third study reported no difference in risk of psychiatric adverse events diagnosed during an emergency department visit or inpatient admission between varenicline users and bupropion users (HR 0.85; 95% CI: 0.55-1.30).
Maltese: It-tielet studju ma rrapporta ebda differenza fir-riskju ta' avvenimenti avversi psikjatriċi matul żjara f'dipartiment tal-emerġenza jew dħul l-isptar għal kura bejn l-utenti ta' varenicline u l-utenti ta' bupropion (HR 0.85; 95% CI: 0.55-1.30).
English: 0.5 mg Tablet
Maltese: 0.5 mg darba kuljum
English: In patients with a high risk of relapse, dose tapering may be considered (see section 4.4).
Maltese: Fil-każ ta' pazjenti b'riskju għoli ta' rikaduta, jista' jiġi kkunsidrat tnaqqis fid-doża (ara sezzjoni 4.4).
English: Continuous Abstinence Rates in Subjects Treated with Champix versus Placebo CHAMPIX n=602
Maltese: Rata ta' Astinenza Kontinwa f'Individwi bi Champix meta mqabbla ma' Plaċebo CHAMPIX n=602
English: Varenicline exhibits linear kinetics when given as single (0.1 to 3 mg) or repeated 1 to 3 mg/day doses.
Maltese: Varenicline jippreżenta kinetiċi lineari meta jingħata bħala doża waħda (0.1 sa 3 mg) jew f'dożi ripetuti minn 1 sa 3 mg/ġurnata.
English: Two of the studies found no difference in risk of neuropsychiatric hospitalisations between varenicline users and nicotine patch users (Hazard Ratio [HR] 1.14; 95% Confidence Interval [CI]: 0.56-2.34 in the first study, and 0.76; 95% CI: 0.40-1.46 in the second study).
Maltese: Tnejn mill-istudji ma sabu ebda differenza fir-riskju ta' kura fl-isptar minħabba avvenimenti newropsikjatriċi bejn l-utenti ta' varenicline u l-utenti ta' gareż tan-nikotina (Proporzjon ta' Periklu [HR] 1.14; 95% Intervall ta' Kunfidenza [CI]: 0.56-2.34 fl-ewwel studju, u 0.76; 95% CI: 0.40-1.46 fit-tieni studju).
English: 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.
Maltese: It-tabella li ġejja mill-istudju pejdatriku ta' hawn fuq turi tqabbil ta' rati ta' astinenza kontinwa (CAR) minn ġimgħat 9-12, ikkonfermati minn test tal-kotinina fl-awrina, għall-popolazzjoni globali talistudju tas-sett ta' analiżi sħiħ u l-popolazzjoni ta' 12-17-il sena.
English: Two identical double-blind clinical trials prospectively compared the efficacy of CHAMPIX (1 mg twice daily), sustained release bupropion (150 mg twice daily) and placebo in smoking cessation.
Maltese: Żewġ provi kliniċi double-blind identiċi qabblu b'mod prospettiv l-effikaċja ta' CHAMPIX (1 mg darbtejn kuljum), bupropion mogħti bil-mod (150 mg darbtejn kuljum) u l-plaċebo fil-waqfien mittipjip.
English: NRT N=1016 n (%)
Maltese: N=1016 n (%)
English: Absorption is virtually complete after oral administration and systemic availability is high.
Maltese: L-assorbiment wara amministrazzoni orali huwa prattikament komplet u d-disponibilita' sistemika hija għolja.
English: During the active treatment period, the incidence of suicide-related events was similar between the varenicline-treated and the placebo-treated subjects (11 vs. 9.3%, respectively).
Maltese: Matul il-perijodu ta' trattament attiv, l-inċidenza ta' avvenimenti relatati mas-suwiċidju kienet simili fis-suġġetti trattati b'varenicline u dawk ittrattati bilplaċebo (11% vs 9.3, rispettivament).
English: 1 mg Tablet
Maltese: 1 mg darbtejn kuljum
English: Treated Composite NPS AE
Maltese: Punt tat-tmiemtal-AE NPS
English: Fungal infection, viral infection Blood and lymphatic system disorders Rare
Maltese: Infezzjoni fungali, infezzjoni virali Disturbi fid-demm u fis-sistema limfatika Rari
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%).
Maltese: Is-CQR tal-erba' ġimgħat (ġimgħa 9 sa ġimgħa 12) għal varenicline u l-plaċebo kienet ta' 53.9% u 19.4%, rispettivament (differenza = 34.5, 95% CI: 27.0% - 42.0%) u s-CA ta' ġimgħa 9-24 kienet ta' 35.2% (varenicline) vs 12.7% (plaċebo) (differenza = 22.5%, 95% CI: 15.
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.
Maltese: Is-sigurtà kardjovaskulari (CV, cardiovascular) ta' CHAMPIX kienet evalwata fl-Istudju f'Individwi bi u mingħajr Storja ta' Disturb Psikjatriku (studju prinċipali; ara sezzjoni 5.1 - Sigurtà Newropsikjatrika) u fl-estensjoni ta' mingħajr kura tiegħu, l-Istudju dwar il-Valutazzjoni tas-Sigurtà Kardjovaskulari, li rreġistra 4595 minn 6293-il pazjent li lestew l-istudju prinċipali (N=8058) u li segwihom sa ġimgħa 52.
English: 42 x 1 mg film-coated tablets
Maltese: 42 x 1 mg pilloli miksija b'rita
English: Steady-state systemic exposure in adolescent patients of bodyweight > 55 kg, as assessed by AUC (0-24), was comparable to that noted for the same doses in the adult population.
Maltese: L-espożizzjoni sistemika, waqt stat stabbli f'pazjenti adoloxxenti li l-piż tagħhom >55 kg, kif valutata bl-AUC (0-24), kienet komparabbli ma dik osservata meta ngħataw l-istess dożi fil-popolazzjoni adulta.
English: In vitro studies indicate that varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Maltese: Studji in vitro jindikaw li varenicline mhux probabbli li jibdel il-farmakokinetiċi ta' komposti li jiġu metabolizzati primarjament minn enzimi taċ-ċitokromu P450.
English: Co-administration of cimetidine, with varenicline increased the systemic exposure of varenicline by 29% due to a reduction in varenicline renal clearance.
Maltese: L-amministrazzjoni ta' cimetidine ma' varenicline żiedet l-espożizzjoni sistemika ta' varenicline b'20% minħabba tnaqqis fl-eliminazzjoni renali ta' varenicline.
English: Bupropion N=1017 n (%)
Maltese: N=1017 n (%)
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).
Maltese: L-użu ta' varenicline, bupropion u NRT fil-koorti psikjatriku ma kienx assoċjat ma' żieda fir-riskju ta' avvenimenti avversi NPS fil-punt tat-tmiem primarju kompost meta mqabbel mal-plaċebo (95% CIs inkludew iż-żero).
English: Bupropion N=989 n (%)
Maltese: N=989 n (%)
English: Examples include theophylline (a medicine to treat breathing problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine to treat diabetes).
Maltese: Eżempji jinkludu theophylline (mediċina għall-kura ta' problemi tan-nifs), warfarin (mediċina biex traqqaq id-demm), u l-insulina (mediċina biex tikkura ddijabete).
English: BATCH NUMBER Lot:
Maltese: Puh/Tel:
English: Keep this leaflet.
Maltese: Studji ta' Osservazzjoni
English: Composite NPS AE Endpoint of severe intensity n (%)
Maltese: Kompost ta' intensità severa n (%)
English: The following adjudicated events occurred with a frequency ≥ 1% in either treatment group during treatment (or in the 30-day period after treatment): nonfatal myocardial infarction (1.1% vs. 0.3% for CHAMPIX and placebo, respectively), and hospitalisation for angina pectoris (0.6% vs. 1.1%).
Maltese: L-avvenimenti aġġudikati li ġejjin seħħew bi frekwenza ta' ≥ 1% fi kwalunkwe grupp tat-trattament waqt il-kura (jew fil-perijodu ta' 30 jum wara ttrattament): infart mijokardijaku mhux fatali (1.1% vs 0.3% għal Champix u plaċebo, rispettivament), u dħul fl-isptar minħabba anġina pectoris (0.6% vs 1.1%).
English: There are limited clinical data on any potential interaction between alcohol and varenicline.
Maltese: Hemm tagħrif kliniku limitat dwar kwalunkwe interazzjoni potenzjali bejn l-alkoħol u varenicline.
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.
Maltese: Kien hemm rati simili ta' mwiet minn kull kawża (CHAMPIX 6 [0.14%]; plaċebo 7 - [0.25%] u mewt b'attakk tal-qalb (CHAMPIX
English: Maximum plasma concentrations of varenicline occur typically within 3-4 hours after oral administration.
Maltese: Il-konċentrazzjonijiet massimi ta' varenicline fil-plasma ġeneralment iseħħu 3-4 sigħat wara li jingħata mill-ħalq.
English: CHAMPIX was evaluated in a double-blind, placebo-controlled trial of 494 patients who had made a previous attempt to quit smoking with CHAMPIX, and either did not succeed in quitting or relapsed after treatment.
Maltese: CHAMPIX ġie evalwat fi studju double-blind, ikkontrollat bi plaċebo, li sar b'CHAMPIX fuq 494 pazjent li kienu għamlu tentattiv fil-passat biex jieqfu jpejpu, u jew ma rnexxielhomx jaqtgħu ssigaretti jew reġgħu bdew ipejpu wara l-kura.
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%).
Maltese: F'dan l-istudju, it-trabi esposti għal CHAMPIX in utero meta mqabbla ma' trabi mwielda minn ommijiet li pejpu waqt it-tqala kellhom rati aktar baxxi ta' malformazzjonijiet konġenitali (3.6% vs 4.3%), twelid mejjet (0.3% vs 0.5%), twelid qabel iż-żmien (7.5% vs 7.9%), li kienu żgħar għall-età ta' ġestazzjoni (12.5% vs 17.1%), u qsim qabel iż-żmien tal-membrana (3.6% vs
English: The 4W-CQR (weeks 9 through 12) and CA rate (weeks 9 through 52) from studies 1 and 2 are included in the following table:
Maltese: Il-4W-CQR (ġimgħa 9 sa ġimgħa 12) u rrata tal-CA (ġimgħa 9 sa ġimgħa 52) minn studju 1 u 2 huma inklużi fit-tabella li ġejja:
English: High-Dose Varenicline Low-Dose Varenicline Placebo
Maltese: Varenicline b'Doża Għolja Varenicline b'Doża Baxxa Plaċebo
English: Completed suicideb Composite NPS AE Endpoint of severe intensity n (%)
Maltese: Imġiba suwiċidali Ideat suwiċidali Suwiċidju komplet Punt tat-tmiemtal-AE NPS kompost ta' intensità severa n (%)
English: The results showed a similar incidence of combined neuropsychiatric adverse events, other than sleep disorders, in patients treated with varenicline compared to patients treated with placebo, with a risk ratio (RR) of 1.01 (95% CI: 0.89-1.15).
Maltese: Ir-riżultati wrew inċidenza simili ta' avvenimenti newropsikjatriċi avversi kkombinati, minbarradisturbi fl-irqad, f'pazjenti kkurati b'varenicline meta mqabbla ma' pazjenti kkurati bi plaċebo, bi proporzjon ta' riskju (RR) ta' 1.01 (95% CI: 0.89-1.15).
English: Nonclinical data indicate varenicline has reinforcing properties albeit with lower potency than nicotine.
Maltese: Informazzjoni mhux klinika tindika li varenicline għandu kwalitajiet rinforzanti għalkemm anqas qawwija min-nikotina.
English: Other medicines and CHAMPIX
Maltese: Mediċini oħra u CHAMPIX
English: Odds ratio (95% CI), p value
Maltese: Proporzjon tal-probabilità (95% CI), valur p
English: Few patients reported these events in the other three trials (4 varenicline, 3 placebo).
Maltese: Ftit pazjenti rrapportaw dawn l-avvenimenti fit-tliet provi l-oħrajn (4 varenicline, 3 plaċebo).
English: 11 x 0.5 mg and 14 x 1 mg
Maltese: Pilloli miksijin b'rita 11 x 0.5 mg u 14 x 1 mg
English: Patient reported craving, withdrawal and reinforcing effects of smoking
Maltese: Pazjenti li rrapportaw effetti tax-xenqa, irtirar u rinforz tat-tipjip
English: Patients in this study (n=1,927) received open-label CHAMPIX 1 mg twice daily for 12 weeks.
Maltese: Il-pazjenti f'dan l-istudju (n=1,927) ngħataw CHAMPIX open-label f'doża ta' 1 mg darbtejn kuljum għal 12-il ġimgħa.
English: Following administration of multiple oral doses to healthy volunteers, steady-state conditions were reached within 4 days.
Maltese: Wara l-amministrazzjoni orali ta' dożi multipli lil voluntiera b'saħħithom, kondizzjonijiet stabbli kienu miksuba fi żmien 4 ijiem.
English: 11 x 0.5 mg film-coated tablets and
Maltese: 11 x 0.5 mg pilloli miksija b'rita u
English: A key secondary endpoint was the continuous abstinence (CA) rate for week 13 through week 52.
Maltese: Mira sekondarja importanti kienet ir-rata ta' l-astinenza kontinwa għal ġimgħa 13 sa ġimgħa 52.
English: Subjects with mild-moderate chronic obstructive pulmonary disease (COPD) The efficacy and safety of CHAMPIX (1 mg twice daily) for smoking cessation in subjects with mild-moderate COPD was demonstrated in a randomised double-blind placebo-controlled clinical trial.
Maltese: Pazjenti b'mard pulmonari ostruttiv kroniku (COPD) minn ħafif għal moderat Prova klinika randomised double-blind ikkontrollata bil-plaċebo wriet l-effikaċja u s-sigurta' ta' CHAMPIX (1 mg darbtejn kuljum) għat-twaqqif tat-tipjip f'pazjenti b'COPD minn ħafif għal moderat.
English: Psychiatric Cohort
Maltese: Koorti Psikjatriku
English: Platelet count decreased Metabolism and nutrition disorders Common
Maltese: Tnaqqis fl-għadd tal-plejlits Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: The safety profile of varenicline was comparable to what was reported in other trials in the general population, including pulmonary safety.
Maltese: Il-profil tas-sigurtà ta' varenicline kien komparabbli ma' dak li kien irrapurtat fi provi oħra fil-popolazzjoni ġenerali, inkluża s-sigurtà pulmonari.
English: The meta-analysis showed that exposure to CHAMPIX resulted in a hazard ratio for MACE of 2.83 (95% confidence interval from 0.76 to 10.55, p=0.12) for patients during treatment and 1.95 (95% confidence interval from 0.79 to 4.82, p=0.15) for patients up to 30 days after treatment.
Maltese: 55, p=0.12) għal pazjenti waqt it-trattament u 1.95 (intervall ta' konfidenza ta' 95% minn 0.79 sa 4.82, p=0.15) għal pazjenti sa 30 ġurnata wara ttrattament.
English: Hazard Ratio (95% CI) vs placebo
Maltese: Riskju (95 % CI) vs plaċebo