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).
Maltese: Studju ta' Sigurtà Newropsikjatrika f'Individwi bi u mingħajr Storja ta' Disturbi PsikjatriċiVarenicline kien evalwat fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, doubleblind, 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: There were no completed suicides reported in the psychiatric cohort.
Maltese: Fil-koorti psikjatriku ma ġiex irrapportat li twettqu suwiċidji.
English: Hepatic impairment
Maltese: Koorti Mhux Psikjatriku
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.
Maltese: L-individwi ntgħażlu b'mod każwali jew għal CHAMPIX 1 mg darbtejn kuljum (n=760) jew għal plaċebo (n=750) għal 24 ġimgħa u ġew segwiti wara l-kura sa ġimgħa 52.
English: In smoking cessation therapy, risk of returning to smoking may be elevated in the period immediately following the end of treatment.
Maltese: Fit-terapija għal waqfien mit-tipjip, ir-riskju ta' rikaduta għat-tipjip huwa għoli fil-perijodu immedjatament wara t-tmiem tal-kura.
English: Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
Maltese: Kull pillola fiha 1 mg varenicline (bħala tartrat).
English: The following table shows the rates of the composite NPS adverse event primary endpoint by treatment group and the risk differences (RDs) (95% CI) vs placebo in the non-psychiatric cohort.
Maltese: It-tabella li ġejja turi r-rati tal-punt tat-tmiemprimarju tal-avveniment avvers tal-NPS kompost permezz tal-grupp tal-kura u d-differenzi tar-riskju (RDs) (95% CI) meta mqabbel mal-plaċebo filkoorti mhux psikjatriku.
English: INFORMATION IN BRAILLE CHAMPIX 0.5 mg
Maltese: CHAMPIX 0.5 mg
English: Delusionsb Hallucinationsb Homicidal ideationb Mania b
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: The fourth study showed no evidence of a higher risk of fatal and non-fatal self- harm (HR of 0.88; 95% CI: 0.52-1.49) in patients prescribed varenicline compared to patients prescribed NRT.
Maltese: Ir-raba' studju ma wera ebda evidenza ta' riskju ogħla ta' ħsara fatali u mhux fatali fuq l-individwu nnifsu (HR ta' 0.88; 95% CI: 0.52-1.49) f'pazjenti li ġew ordnati varenicline meta mqabbla ma' pazjenti li ġew ordnati NRT. Rari kien osservat suwiċidju matul it-tliet xhur wara li l-pazjenti bdew kwalunkwe kura b'mediċina (żewġ każijiet f'31,260 utent ta' varenicline u sitt każijiet f'81,545 utent ta' NRT).
English: Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Maltese: - Pakkett għall-bidu tal-kura li fih 2 folji; folja trasparenti ta' 11 x CHAMPIX 0.5 mg u 14 x 1 mg pilloli miksija b'rita u folja trasparenti ta' 28 jew 2 folji trasparenti ta' 14 x CHAMPIX 1 mg pilloli miksija b'rita f'pakkett tal-kartun.
English: You start with the white tablet and then usually go to the light blue tablet.
Maltese: Inti għandek tibda bil-pillola lbajda, imbagħad normalment taqleb fuq il-pillola l-blu ċara.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 0.5 mg varenicline film-coated tablets
Maltese: Pakkett fi flixkun tal-politin ta' densita' għolja (HDPE) għal 56 x 0.5 mg varenicline pilloli miksijin b'rita
English: There were rare reports of life-threatening angioedema requiring urgent medical attention due to respiratory compromise.
Maltese: Rari kien hemm rapporti ta' anġjoedema b'riskju ta' fatalita' li kellha bżonn attenzjoni medika urġenti minħabba li kien hemm diffikulta' serja fis-sistema respiratorja.
English: Numbers 1 to 14 sun as symbol moon as symbol
Maltese: Numru 1 sa 14 simbolu tax-xemx simbolu tal-qamar
English: Placebo N=999 n (%)
Maltese: N=999 n (%)
English: Placebo n=750
Maltese: Plaċebo (n=750)
English: Giving up smoking with or without treatment can cause various symptoms.
Maltese: Il-waqfien mit-tipjip bi jew mingħajr kura huwa assoċjat ma' diversi sintomi.
English: Arthralgia, myalgia, back pain Muscle spasms, musculoskeletal chest pain Joint stiffness, costochondritis Renal and urinary disorders Uncommon Rare
Maltese: Artralġja, uġigħ fil-muskoli, uġigħ fid-dahar Spażmi fil-muskoli, uġigħ fil-muskoli u fl-għadam tas-sider Ebusija tal-ġogi, kostokondrite
English: Numbers 1 to 28 sun as symbol moon as symbol
Maltese: Numri 1 sa 28 simbolu tax-xemx simbolu tal-qamar
English: The CHAMPIX safety profile in this study was consistent with that of pre-marketing studies.
Maltese: Il-profil tas-sigurtà ta' CHAMPIX f'dan l-istudju kien konsistenti mal-istudji ta' qabel it-tqegħid fissuq.
English: Follow-on (maintenance) packs containing 2 or 4 clear blisters of 14 or 2 clear blisters of 28 x CHAMPIX 0.5 mg film-coated tablets in card packaging.
Maltese: - Pakketti ta' kontinwazzjoni (manteniment) li fihom 2 jew 4 folji trasparenti ta' 14 jew 2 folji trasparenti ta' 28 x CHAMPIX 0.5 mg pilloli miksijin b'rita f'pakkett tal-kartun.
English: Number of Patients Treated 990 Composite NPS AE Primary Endpoint, n (%)
Maltese: Numru ta' Pazjenti Kkurati Punt Tat-tmiemPrimarju tal-AE NPS Kompost, n (%)
English: Neuropsychiatric symptoms
Maltese: Sintomi newropsikjatriċi
English: In patients with severe renal impairment, the concomitant use of cimetidine and varenicline should be avoided.
Maltese: F'pazjenti b'indeboliment akut tal-kliewi, l-użu f'daqqa ta' cimetidine u varenicline għandu jiġu evitat.
English: Scotoma, scleral discolouration, mydriasis, photophobia, myopia, lacrimation increased
Maltese: Skotoma, tifi tal-kulur tal-isklera,, midrijasi, fotofobija, mijopija, żieda fid-dmugħ
English: 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.
Maltese: Din il-meta-analiżi kienet tinkludi prova waħda (N=127) f'pazjenti bi storja ta' skiżofrenja jew disturb skiżoaffettiv u prova oħra (N=525) f'pazjenti bi storja ta' dipressjoni.
English: Following two-week titration, patients randomised to varenicline with a body weight >55 kg received 1 mg twice daily (high dose group) or 0.5 mg twice daily (low dose group), while patients with a body weight ≤55 kg received 0.5 mg twice daily (high dose group) or 0.5 mg once daily (low dose group).
Maltese: Wara titrazzjoni ta' ġimagħtejn, il-pazjenti randomizzati għal varenicline b'piż tal-ġisem >55 kg irċivew 1 mg darbtejn kuljum (grupp ta' doża għolja) jew 0.5 mg darbtejn kuljum (grupp ta' doża baxxa), filwaqt li pazjenti b'piż tal-ġisem ≤55 kg irċivew 0.5 mg darbtejn kuljum (grupp ta' doża għolja) jew 0.5 mg darba kuljum (grupp ta' doża baxxa).
English: Treatment initiation pack in an outer carton containing 1 pack with 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging and 2 packs each containing 2 clear blisters of 28 or 4 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Maltese: - Pakkett għall-bidu tal-kura ġo kartuna ta' barra li fih pakkett 1 b'folja trasparenti ta' 11 x CHAMPIX 0.5 mg u 14 x 1 mg pilloli miksija b'rita u folja trasparenti ta' 28 jew 2 folji trasparenti ta' 14 x CHAMPIX 1 mg pilloli miksija b'rita f'pakkett tal-kartun u żewġ pakketti li fihom 2 folji trasparenti ta' 28 jew 4 folji trasparenti ta' 14 x CHAMPIX 1 mg pilloli miksija b'rita f'pakkett tal-kartun.
English: Upper respiratory tract inflammation, respiratory tract congestion, dysphonia, rhinitis allergic, throat irritation, sinus congestion, upperairway cough syndrome, rhinorrhoea Laryngeal pain, snoring Gastrointestinal disorders Very common Nausea Common
Maltese: Aċċessjoni, tregħid, letarġija, ipoestesija Aċċident ċerebrovaskulari, ipertonja, dysarthria, koordinazzjoni mhux normali, hypoġewsja, disturb fir-ritmu ċirkadjani tal-irqad Telf temporanju mis-sensi Disturbi fl-għajnejn Mhux komuni Rari
English: CI=confidence interval; N=number of subjects randomised; n=the number of subjects who, at each visit from weeks 9 to 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and at any of these visits were confirmed to have quit based on urine cotinine test.
Maltese: CI=intervall ta' kunfidenza; N=numru ta' individwi randomizzati; n=in-numru ta' individwi li, f'kull żjara minn ġimgħat 9 sa 12 (inklużivi), ma rrappurtaw l-ebda tipjip u l-ebda użu ta' prodotti oħra li fihom in-nikotina mill-aħħar żjara talistudju/l-aħħar kuntatt (fuq l-Inventarju tal-Użu tan-Nikotina) u fi kwalunkwe waħda minn dawn iż-żjarat ġew ikkonfermati li waqfu abbażi ta' test tal-kotinina fl-awrina.
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:
Maltese: Fil-koorti mhux psikjatriku, il-perċentwal ta' individwi b'ideat u/jew imġiba suwiċidali abbażi talIskala tal-Klassifika 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: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja ta' l-aluminju f'pakkett li fih 56 x 0.5 mg pillola miksija b'rita f'pakkett sekondarju tal-kartun issiġillat bis-sħana.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Maltese: Informazzjoni ddettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini http://www.ema.europa.eu.
English: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja ta' l-aluminju li fihom folja 1 trasparenti ta' 11 x 0.5 mg u 14 x 1 mg pillola miksija b'rita u folja 1 trasparenti ta' 28 jew 2 folji trasparenti ta' 14 x 1 mg pillola miksija b'rita f'pakkett sekondarju tal-kartun issiġillat bis-sħana.
English: This medicine has been prescribed for you only.
Maltese: Din il-mediċina ma teħtieġx kondizzjonijiet ta' ħażna speċjali.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 0.5 mg and 28 x 0.5 mg varenicline film-coated tablets, heat sealed card
Maltese: Pakkett folji ta' 14 x 0.5 mg u 28 x 0.5 mg varenicline pilloli miksijin b'rita, kartuna issiġillata bissħana
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.
Maltese: Il-farmakokinetiċi ta' varenicline f' dożi singli u multipli, ġew investigati f'pazjenti pedjatriċi li għandhom bejn 12 u 17 -il sena, u kienu bejn wieħed u ieħor proporzjonali għad-doża, bejn dożi ta' 0.5 mg u 2 mg kulljum kif ġew studjati.
English: In vitro studies demonstrate that varenicline does not inhibit human renal transport proteins at therapeutic concentrations.
Maltese: Studji in vitro juru li varenicline ma jinibixxix il-proteini tat-trasport renali uman f'konċentrazzjonijiet terapewtiċi.
English: Tablet Core - CHAMPIX 0.5 mg and 1 mg film-coated tablets Cellulose, Microcrystalline
Maltese: Qalba tal-Pillola - CHAMPIX 0.5 mg u 1 mg pilloli miksijin b'rita
English: During treatment plus 30 days MACE, n (%)
Maltese: Waqt il-kura flimkien ma' 30 jum MACE, n (%)
English: Varenicline did not affect the pharmacokinetics of metformin.
Maltese: Varenicline ma affettwax il-farmakokinetiċi ta' metformin.
English: Carton pack with 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets
Maltese: Pakkett tal-kartun li fih pakkett folji ta' 11 x 0.5 mg varenicline pilloli miksijin b'rita u pakkett folji ta' 14 x 1 mg varenicline pilloli miksijin b'rita
English: Heat sealed card pack containing either 2 or 4 blister packs of 14 x 0.5 mg varenicline film-coated tablets or 2 blister packs of 28 x 0.5 mg varenicline film-coated tablets- inner and outer labelling
Maltese: Pakkett tal-kartun issiġillat bis-sħana li fih jew 2 jew 4 pakketti ta' folji ta' 14 x 0.5 mg varenicline pilloli miksijin b'rita jew 2 pakketti ta' folji ta' 28 x 0.5 mg varenicline pilloli miksijin b'rita - tikketta ta' ġewwa u ta' barra
English: 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.
Maltese: Il-proċeduri ta' ttestjar statistiku speċifikati minn qabel waqqfu littestjar wara li t-tqabbil tal-kura ta' varenicline b'doża għolja kontra Plaċebo fl-istudju globali ma kisibx sinifikanza statistika.
English: Very common Abnormal dreams, insomnia Uncommon
Maltese: Tħossok anormali Ostilità
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja ta' l-aluminju f'pakkett li fih 28 x 0.5 mg pillola miksija b'rita f'pakkett sekondarju tal-kartun issiġillat bis-sħana.
English: In this group, the discontinuation rates for the most common adverse reactions in varenicline treated patients were as follows: nausea (2.7% vs. 0.6% for placebo), headache (0.6% vs. 1.0% for placebo), insomnia (1.3% vs. 1.2% for placebo), and abnormal dreams (0.2% vs. 0.2% for placebo).
Maltese: F'dan il-grupp, ir-rati tat-twaqqif għall-iktar reazzjonijiet avversi komuni f'pazjenti kkurati b'varenicline huma kif ġej: dardir (2.7% vs 0.6% għall-plaċebo), uġigħ ta' ras (0.6% vs 1.0% għall-plaċebo), insomnja (1.3% vs 1.2% għall-plaċebo), u ħolm anormali (0.2% vs 0.2% għall-plaċebo).
English: CHAMPIX can help to relieve the craving and withdrawal symptoms associated with stopping smoking.
Maltese: CHAMPIX jista' jgħinek biex ittaffi x-xenqa u s-sintomi ta' l-irtirar assoċjati mal-waqfien mit-tipjip.
English: 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.
Maltese: Fit-tmiem tal-kura, it-twaqqif ta' CHAMPIX ġie assoċjat ma' żieda fl-irritabilita', xenqa ta' tipjip, depressjoni, u/jew nuqqas ta' rqad f'sa 3% tal-pazjenti.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja ta' l-aluminju f'pakkett li fih 112 x 1 mg pillola miksija b'rita f'kaxxa.
English: PCTFE/PVC blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in one secondary heat sealed card pack and PCTFE/PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 x 1 mg film-coated tablets.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja tal-aluminju li fihom folja waħda trasparenti ta' 11 x 0.5 mg u 14 x 1 mg pillola miksija b'rita u folja 1 trasparenti ta' 28 jew 2 folji trasparenti ta' 14 x 1 mg pillola miksija b'rita f'pakkett sekondarju wieħed tal-kartun issiġillat bis-sħana u folji tal-PCTFE/PVC b'rinforz ta' folja tal-aluminju li fihom żewġ pakketti sekondarji tal-kartun issiġillati bis-sħana li kull wieħed fih 56 x 1 mg pillola miksija b'rita.
English: Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Maltese: - Pakkett għall-bidu tal-kura li fih 2 folji; folja trasparenti ta' 11 x CHAMPIX 0.5 mg pilloli miksijin b'rita u folja trasparenti ta' 14 x CHAMPIX 1 mg pilloli miksijin b'rita f'pakkett talkartun.
English: Gastrooesophageal reflux disease, vomiting, constipation, diarrhoea, abdominal distension, abdominal pain, toothache, dyspepsia, flatulence, dry mouth
Maltese: Marda tar-rifluss gastro-esofagali, rimettar, stitikezza, dijarea, distensjoni addominali, uġigħ addominali, uġigħ fis-snien, dispepsja, gass fl-istonku, ħalq xott
English: The primary safety endpoint was a composite of neuropsychiatric adverse events that have been reported in post-marketing experience.
Maltese: Il-punt tat-tmiem tas-sigurtà primarja kien kompost ta' avvenimenti newropsikjatriċi avversi li ġew irrapportati fl-esperjenza ta' wara t-tqegħid fis suq.
English: 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.
Maltese: It-tabella li ġejja turi l-inċidenza ta' MACE u Proporzjonijiet ta' Riskju vs plaċebo għall-gruppi kollha waqt il-kura, u kumulattivi għall-kura flimkien ma' 30 jum u sal-aħħar tal-istudju.
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)
Maltese: Seħħew effetti sekondarji serji ta' frekwenza mhux komuni jew rari f'nies li ppruvaw iwaqqfu t-tipjip b'CHAMPIX: aċċessjoni, puplesija, attakk tal-qalb, ħsibijiet ta' suwiċidju, telf ta' kuntatt mar-realtà u ma jkunux jistgħu jaħsbu jew jieħdu ġudizzju b'mod ċar (psikosi), bidliet fil-ħsieb jew fl-imġiba (bħal aggressjoni u mġiba mhux normali).
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja ta' l-aluminju f'pakkett li fih 140 x 1mg pillola miksija b'rita f'kaxxa.
English: Metformin had no effect on varenicline pharmacokinetics.
Maltese: Metformin ma kellux effett fuq ilfarmakokinetiċi ta' varenicline.
English: Anxietya
Maltese: Puplesija
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.
Maltese: It-tabella li ġejja turi r-rati tal-punt tat-tmiem primarju tal-avveniment avvers tal-NPS kompost permezz tal-grupp tal-kura u l-RDs (95% CI) meta mqabbel mal-plaċebo fil-koorti psikjatriku.
English: Heat sealed card pack containing 1 blister pack of 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 - inner and outer labelling.
Maltese: 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 - tikketta ta' ġewwa u ta' barra.
English: Varenicline distributes into tissues, including the brain.
Maltese: Varenicline jitqassam fit-tessuti, inkluż il-moħħ.
English: Endpoint Components n
Maltese: ANNESS III
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg and 28 x 1 mg varenicline film-coated tablets, heat sealed card
Maltese: Pakkett folji ta' 14 x 1 mg u 28 x 1 mg varenicline pilloli miksijin b'rita, kartuna issiġillata bis-sħana
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 1 mg varenicline film-coated tablets
Maltese: Pakkett fi flixkun tal-politin ta' densita' għolja (HDPE) għal 56 x 1 mg varenicline pilloli miksijin b'rita
English: EXPIRY DATE EXP: MM/YYYY
Maltese: Approwċ gradwali għall-waqfien mit-tipjip
English: numbers 1 to 14 numbers 1 to 28 sun as symbol moon as symbol
Maltese: Aqra l-fuljett ta' tagħrif qabel l-użu numru 1 sa 14 numru 1 sa 28 simbolu tax-xemx simbolu tal-qamar
English: The primary endpoint of the study was the CO-confirmed, 4-week Continuous Quit Rate (4W CQR) from week 9 through week 12 and a key secondary endpoint was the Continuous Abstinence (CA) from Week 9 through Week 52.
Maltese: Il-mira ewlenija ta' dan l-studju kienet ir-rata ta' waqfien kontinwu ta' 4 ġimgħat (4W-CQR) mid-9 sat-12-il ġimgħa, ikkonfermata mil-livell tal-monossidu karboniku (CO). Mira sekondarja importanti ta' dan l-istudju kienet ir-Rata ta' Astinenza Kontinwa (CA) mid-9 sat-52-il ġimgħa.
English: PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Maltese: Folji tal-PVC b'rinforz ta' folja ta' l-aluminju li fihom folja 1 trasparenti ta' 11 x 0.5 mg u 14 x 1 mg pillola miksija b'rita u folja 1 trasparenti ta' 28 jew 2 folji trasparenti ta' 14 x 1 mg pillola miksija b'rita f'pakkett sekondarju tal-kartun issiġillat bis-sħana.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Maltese: Folji tal-PCTFE/PVC b'rinforz ta' folja ta' l-aluminju f'pakkett li fih 56 x 1 mg pillola miksija b'rita f'pakkett sekondarju tal-kartun issiġillat bis-sħana.
English: Semen analysis abnormal, C-reactive protein increased, blood calcium decreased * Frequencies are estimated from a post-marketing, observational cohort study Reporting of suspected adverse reactions
Maltese: Analiżi tas-semen mhux normali, żieda fil-proteina reattiva Ċ, tnaqqis tal-kalċju fid-demm * Il-frekwenzi huma stmati fuq studju koorti ta' osservazzjoni wara t-tqegħid fis-suq
English: The results for the 4W CQR (weeks 9 through 12) and CA rate (weeks 9 through 52) are shown in the following table:
Maltese: Ir-riżultati tal-4W-CQR (ġimgħa 9 sa ġimgħa 12) u r-rata tal-CA (ġimgħa 9 sa ġimgħa 52) huma inklużi fit-tabella li ġejja:
English: PHARMACEUTICAL FORM AND CONTENTS 4-week treatment initiation pack containing: 11 x 0.5 mg film-coated tablets and
Maltese: Pakkett ta' ta' kura inizjali għal 4 ġimgħat li fih: 11 x 0.5 mg pilloli miksija b'rita u
English: AUTHORISATION
Maltese: Notturja
English: Follow-on (maintenance) packs containing 2 or 4 clear blisters of 14 or 2 clear blisters of 28 x CHAMPIX 1 mg film-coated tablets in card packaging.
Maltese: - Pakketti ta' kontinwazzjoni (manteniment) li fihom 2 jew 4 folji trasparenti ta' 14 jew 2 folji trasparenti ta' 28 x CHAMPIX 1 mg pilloli miksijin b'rita f'pakkett tal-kartun.