qanastek/EMEA-V3 huggingface dataset:
Nervous system disorders Very common Common Uncommon Cardiac disorders
Komuni ħafna Mhux komuni Disturbi fis- sistema Komuni ħafna Komuni Mhux komuni Disturbi tal- qalb
Headache Somnolence, dizziness, dysgeusia Tremor, coordination abnormal, dysarthria, hypertonia, restlessness, dysphoria, hypoaesthesia, hypogeusia, lethargy, libido increased, libido decreased
Ħolm abnormali, nuqqas ta 'rqad Reazzjoni ta' paniku, bradyphrenia, ħsieb abnormali, tibdil fil- burdata nervuża Uġigħ ta 'ras Ngħas, sturdament, togħma ħażina Tregħid, koordinazzjoni abnormali, dysarthria, hypertonia, irrekwitezza, disforja, ipoestesija, hypogeusia, letarġija, żieda fil- libido, tnaqqis fil - libido
Uncommon Eye disorders
Mhux komuni Disturbi fl- għajnejn
Atrial fibrillation, palpitations
Fibrillazzjoni ta 'l- atriji, palpitazzjonijiet
Scotoma, scleral discolouration, eye pain, mydriasis, photophobia, myopia, lacrimation increased
Skotoma, tidnis ta 'l- isklerotika, uġigħ fl- għajnejn, midrijasi, fotofobija, mijopija, żieda fit- tidmigħ
Ear and labyrinth disorders Uncommon
Disturbi fil- widnejn Mhux komuni
Tinnitus
u fis- sistema labirintika Żanżin tal- widnejn
Respiratory, thoracic and mediastinal disorders Uncommon
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni
Dyspnoea, cough, hoarseness, pharyngolaryngeal pain, throat irritation, respiratory tract congestion, sinus congestion, post nasal drip, rhinorrhoea, snoring
Dispnea, sogħla, ħanqa, uġigħ laringo- farinġiku, irritazzjoni tal- gerżuma, konġestjoni ta 'l- apparat respiratorju, konġestjoni tas- sinus, post nasal drip, imħat, inħir
Gastrointestinal disorders Very common Common
Disturbi gastro- intestinali Komuni ħafna Komuni
Nausea Vomiting, constipation, diarrhoea, abdominal distension, stomach discomfort, dyspepsia, flatulence, dry mouth
Dardir Rimettar, stitikezza, dijarea, distensjoni addominali, diqa fl- istonku, dispepsja, gass fl- istonku, ħalq xott
Haematemesis, haematochezia, gastritis, gastrooesophageal reflux disease, abdominal pain, change of bowel habit, abnormal faeces, eructation, aphthous stomatitis, gingival pain, tongue coated
Ematemesi, haematochezia, gastrite, mard tar- rifluss gastro- esofagali, uġigħ addominali, bidla fil- mudell ta 'l- ippurgar tiegħek, purgar abnormali, tifwiq, aphthous stomatitis, uġigħ fil- ħanek, ilsien miksi
Skin and subcutaneous tissue disorders Uncommon
Disturbi fil- ġilda u Mhux komuni
Rash generalised, erythema, pruritus, acne, hyperhidrosis, night sweats
fit- tessuti ta 'taħt il- ġilda Raxx ġeneralizzat, eritema, ħakk, akne, iperidrosi, tagħriq bil- lejl
connective tissue disorders
Disturbi muskolu- skeltrali u tal- connective tissue Mhux komuni
Joint stiffness, muscle spasms, chest wall pain, costochondritis
Ebusija tal- ġogi, spażmi fil- muskoli, uġigħ fil- ħajt tas- sider, kostokondrite
Reproductive system and breast disorders Uncommon
Disturbi fil- kliewi u fis- sistema urinarja Mhux komuni Disturbi fis- sistema Mhux komuni
Menorrhagia, vaginal discharge, sexual dysfunction
Glikosurja, notturja, poliurja riproduttiva u fis- sider Mestrwazzjoni esaġerata, tnixxija vaġinali, disfunzjoni sesswali
General disorders and administration site conditions Common Uncommon Investigations
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Komuni Mhux komuni Stħarriġ
Fatigue Chest discomfort, chest pain, pyrexia, feeling cold, asthenia, circadian rhythm sleep disorder, malaise, cyst
Għeja Diqa fis- sider, uġigħ fis- sider, deni, sensazzjoni ta 'kesħa, astenja, disturb tal- ħin ta' l- irqad, telqa, ċista
Blood pressure increased, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased, heart rate increased, liver function test abnormal, platelet count decreased, weight increased, semen abnormal, C-reactive protein increased, blood calcium decreased
Pressjoni tad- demm aktar għolja, depressjoni fis- segment ST fuq l - elektrokardjogramm, tnaqqis fil- wisa 'tat- T wave fuq l - elektrokardjogramm, żieda fir- ritmu tal- qalb, test tal- funzjoni tal- fwied mhux normali, tnaqqis fl- għadd tal- pjastrini, żieda fil- piż, semen abnormali, żieda fil- proteina C- reattiva, tnaqqis tal- kalċju fid- demm
Post-marketing cases of myocardial infarction, depression and suicidal ideation have been reported in patients taking varenicline (see section 4.4).
Wara it- tqegħid tal- prodott fis- suq, każijiet ta ’ infarti mijokardijaċi, depressjoni u ideat ta ’ suwiċidju ġew irrappurtati f’ pazjenti li jieħdu varenicline (ara sezzjoni 4. 4).
There have also been reports of hypersensitivity reactions, such as angioedema and facial swelling.
Kien hemm ukoll rapporti ta ’ sensittivita ’ eċċessiva, bħal anġjoedema u nefħa fil- wiċċ.
No cases of overdose were reported in pre-marketing clinical trials.
Ebda każi ta 'doża eċċessiva ma ġew irrapportati fil- provi kliniċi ta' qabel it- tqegħid fis- suq.
6 In case of overdose, standard supportive measures should be instituted as required.
F' każ ta 'doża eċċessiva, għandhom jiddaħħlu miżuri standard ta' sostenn kif ikun meħtieġ.
Varenicline has been shown to be dialyzed in patients with end stage renal disease (see section 5.2), however, there is no experience in dialysis following overdose.
Varenicline ġie muri li jiġi dijalizzat f' pazjenti b' mard tal- kliewi ta 'l- aħħar stadju (ara sezzjoni 5. 2), madankollu, m' hemmx esperjenza ta' dijaliżi wara doża eċċessiva.
Active substances used in nicotine dependence, ATC code:
Sustanzi attivi użati fid- dipendenza fuq in- nikotina, Kodiċi ATC:
Varenicline binds with high affinity and selectivity at the α 4β 2 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.
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.
Electrophysiology studies in vitro and neurochemical studies in vivo have shown that varenicline binds to the α 4β 2 neuronal nicotinic acetylcholine receptors and stimulates receptor-mediated activity, but at a significantly lower level than nicotine.
L- istudji ta 'l- elettrofiżjoloġija in vitro u l- istudji newrokimiċi in vivo urew li varenicline jaqbad mar - riċevituri nikotiniċi newronali ta' l- aċetilkolina α4β2 u jistimula attivita 'medjata mir- riċevituri, iżda f' miżura sostanzjalment aktar baxxa min- nikotina.
Nicotine competes for the same human α 4β 2 nAChR binding site for which varenicline has higher affinity.
In- nikotina tikkompeti għall- istess post ta 'tqabbid tan- nAChR α4β2 li għalih varinicline għandu affinita' akbar.
Therefore, varenicline can effectively block nicotine's ability to fully activate α 4β 2 receptors and the mesolimbic dopamine system, the neuronal mechanism underlying reinforcement and reward experienced upon smoking.
Għalhekk, varenicline jista 'jimblokka b' mod effettiv il- kapaċita' tan- nikotina li tattiva kompletament ir- riċevituri α4β2 u s- sistema mesolimbika tad- dopamine, il- mekkaniżmu newronali fil- bażi tar- rinforz u l- gratifikazzjoni li wieħed iħoss meta jpejjep.
Varenicline is highly selective and binds more potently to the α 4β 2 receptor subtype (Ki=0.15 nM) than to other common nicotinic receptors (α 3β 4 Ki=84 nM, α 7 Ki= 620 nM, α 1βγδ Ki= 3,400 nM), or to non-nicotinic receptors and transporters (Ki > 1µM, except to 5-HT3 receptors:
Varenicline hu selettiv ħafna u jaqbad b' mod aktar b' saħħtu mas- sottotip tar - riċettur 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 għar - riċevituri 5- HT3:
The efficacy of CHAMPIX in smoking cessation is a result of varenicline's partial agonist activity at the α 4β 2 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 α 4β 2 receptors (antagonist activity).
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).
Clinical Efficacy
Effikaċja Klinika
The efficacy of CHAMPIX in smoking cessation was demonstrated in 3 clinical trials involving chronic cigarette smokers (≥ 10 cigarettes per day).
L- effikaċja ta 'CHAMPIX fil- waqfien mit- tipjip ġiet murija fi 3 provi kliniċi li kienu jinvolvu fumaturi kroniċi tas- sigarretti (≥10 sigarretti kuljum).
2619 patients received CHAMPIX 1mg BID (titrated during the first week), 669 patients received bupropion 150 mg BID (also titrated) and 684 patients received placebo.
2619- il pazjent irċevew CHAMPIX 1mg BID (titrati matul l- ewwel ġimgħa), 669 pazjent irċevew bupropion 150 mg BID (ukoll titrati) u 684 pazjent irċevew il- plaċebo.
Comparative Clinical Studies
Studji Kliniċi Komparattivi
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.
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 mit - tipjip.
In these 52-week duration studies, patients received treatment for 12 weeks, followed by a 40-week non- treatment phase.
F' dawn l- istudji li damu 52 ġimgħa, il- pazjenti rċevew kura għal 12- il ġimgħa, segwiti minn fażi ta '40 ġimgħa mingħajr kura.
The primary endpoint of the two studies was the carbon monoxide (CO) confirmed, 4-week continuous quit rate (4W-CQR) from week 9 through week 12.
7 L- endpoint primarju taż- żewġ studji kien ir- rata ta 'waqfien kontinwu ta' 4 ġimgħat (4W- CQR) mid- 9 sat- 12- il ġimgħa, ikkonfermata mil- livell tal- monossidu karboniku (CO).
The primary endpoint for CHAMPIX demonstrated statistical superiority to bupropion and placebo.
L- endpoint primarju għal CHAMPIX wera superjorita 'statistika fil- konfront ta' bupropion u l- plaċebo.
After the 40 week non-treatment phase, a key secondary endpoint for both studies was the Continuous Abstinence Rate (CA) at week 52.
Wara l- fażi ta '40 ġimgħa mingħajr kura, endpoint sekondarju importanti għaż- żewġ studji kienet ir - Rata ta' Astinenza Kontinwa (CA) fit- 52 ġimgħa.
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.
Il- CA ġiet definita bħala l- proporzjoni tas- suġġetti kkurati kollha li ma pejpux (lanqas nifs wieħed ta 'sigarrett) minn Ġimgħa 9 sa Ġimgħa 52 u li ma kellhomx kejl ta' CO minfuħ 'il barra ta' > 10 ppm.
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:
Il- 4W- CQR (ġimgħa 9 sa ġimgħa 12) u r- rata tal - CA (ġimgħa 9 sa ġimgħa 52) minn studju 1 u 2 huma inklużi fit- tabella li ġejja:
Study 1 (n=1022)
Studju 1 (n=1022)
Study 2 (n=1023)
Studju 2 (n=1023)
Wk 9-52 4W CQR 22.1% 44.0% 16.4% 30.0% 8.4% 17.7% 3.13 3.85
CA Wk 9- 52 4W CQR
CA
CA Wk 9- 52
CHAMPIX vs placebo Odds ratio CHAMPIX vs bupropion
CHAMPIX Bupropion Plaċebo Odds ratio CHAMPIX vs plaċebo Odds ratio CHAMPIX vs bupropion
p < 0.0001 1.96 p < 0.0001
44. 4% 29. 5% 17. 7% 3. 91 p < 0. 0001 1. 96 p < 0. 0001
p < 0.0001 p < 0.0001 1.45 1.89 p=0.0640 p < 0.0001
22. 1% 44. 0% 16. 4% 30. 0% 8. 4% 17. 7% 3. 13 3. 85 p < 0. 0001 p < 0. 0001 1. 45 1. 89 p=0. 0640 p < 0. 0001
p < 0.0001 1.72 p=0.0062
23. 0% 15. 0% 10. 3% 2. 66 p < 0. 0001 1. 72 p=0. 0062
Patient reported craving, withdrawal and reinforcing effects of smoking Across both Studies 1 and 2 during active treatment, craving and withdrawal were significantly reduced in patients randomized to CHAMPIX in comparison with placebo.
Pazjenti li rrapportaw effetti tax- xenqa, irtirar u rinforz tat- tipjip Fiż- żewġ Studji 1 u 2 matul il- kura attiva, ix- xenqa u l- irtirar tnaqqsu b' mod sinifikanti fil- pazjenti magħżula b' mod każwali għal CHAMPIX meta mqabbel mal- plaċebo.
CHAMPIX also significantly reduced reinforcing effects of smoking that can perpetuate smoking behaviour in patients who smoke during treatment compared with placebo.
CHAMPIX naqqas ukoll b' mod sinifikanti l- effetti rinforzanti tat- tipjip li jistgħu jipperpetwaw il- komportament tat- tipjip f' pazjenti li jpejpu waqt il- kura meta mqabbel mal- plaċebo.
The effect of varenicline on craving, withdrawal and reinforcing effects of smoking were not measured during the non-treatment long-term follow-up phase.
L- effett ta 'varenicline fuq l- effetti tax- xenqa, l- irtirar u r- rinforz tat- tipjip ma kinux imkejla waqt il- fażi ta' wara fuq perjodu fit- tul mingħajr kura.
Maintenance of Abstinence Study The third study assessed the benefit of an additional 12 weeks of CHAMPIX therapy on the maintenance of abstinence.
Studju dwar iż- Żamma ta 'l- Astinenza It- tielet studju evalwa l- vantaġġ ta' 12- il ġimgħa addizzjonali ta 'terapija b' CHAMPIX fuq iż- żamma ta' l- astinenza.
Patients in this study (n=1,927) received open-label CHAMPIX 1 mg twice daily for 12 weeks.
Il- pazjenti f' dan l- istudju (n=1, 927) ngħataw CHAMPIX open- label f' doża ta '1 mg darbtejn kuljum għal 12- il ġimgħa.
Patients who stopped smoking by Week 12 were then randomized to receive either CHAMPIX (1 mg twice daily) or placebo for an additional 12 weeks for a total study duration of 52 weeks.
Il- pazjenti li waqfu jpejpu sa Ġimgħa 12 imbagħad ġew magħżula b' mod każwali biex jiċievu jew CHAMPIX (1 mg darbtejn kuljum) jew plaċebo għal 12- il ġimgħa oħra għal tul totali ta 'l- istudju ta' 52 ġimgħa.
The primary study endpoint was the CO-confirmed continuous abstinence rate from week 13 through week 24 in the double-blind treatment phase.
L- endpoint prinċipali ta 'l- istudju kienet ir- rata ta' l- astinenza kontinwa kkonfermata mill- CO minn ġimgħa 24 sa ġimgħa 24 fil- fażi ta 'kura double- blind.
A key secondary endpoint was the continuous abstinence (CA) rate for week 13 through week 52.
Endpoint sekondarju importanti kienet ir- rata ta 'l- astinenza kontinwa għal ġimgħa 13 sa ġimgħa 52.
This study showed the benefit of an additional 12-week treatment with CHAMPIX 1 mg twice daily for the maintenance of smoking cessation compared to placebo.
Dan l- istudju wera s- siwi ta '12- il ġimgħa addizzjonali ta' kura b' CHAMPIX 1 mg darbtejn kuljum għall- manteniment tal- waqfien mit- tipjip meta mqabbel mal- plaċebo.
The odds of maintaining abstinence at week 24, following an additional 12 weeks of treatment with CHAMPIX, were 2.47 times those for placebo (p < 0.0001).
Il- probabbilta 'li tinżamm l - astinenza f' ġimgħa 24, wara 12- il ġimgħa addizzjonali ta' kura b' CHAMPIX, kienet 2. 47 drabi aktar minn dik għall- plaċebo (p < 0. 0001).
Superiority to placebo for CA was maintained through week 52 (Odds Ratio=1.35, p=0.0126).
Is- superjorita 'fil- konfront tal- plaċebo għall- CA nżammet sa ġimgħa 52 (Odds Ratio=1. 35, p=0. 0126).
The key results are summarised in the following table:
Ir- riżultati prinċipali huma miġbura fil- qosor fit- tabella li ġejja:
Placebo n=604
Plaċebo n=604
Difference (95% CI)
Differenza (95% CI)
CA wk 13-24
CA wk 13- 24
70.6%
70. 6%
49.8%
49. 8%
20.8%
20. 8%
2.47
2. 47
(15.4%, 26.2%)
(15. 4%, 26. 2%)
(1.95, 3.15)
(1. 95, 3. 15)
44.0%
CA wk 13- 52
37.1%
37. 1%
6.9% (1.4%,12.5%)
6. 9% (1. 4%, 12. 5%)
1.35 (1.07, 1.70)
1. 35 (1. 07, 1. 70)
There is currently limited clinical experience with the use of CHAMPIX among black people to determine clincial efficacy.
Attwalment teżisti esperjenza klinika limitata dwar l- użu ta 'CHAMPIX fost nies suwed biex tkun tista' tiġi stabbilita l- effikaċja klinika.
5.2 Pharmacokinetic properties
8 5. 2 Tagħrif farmakokinetiku
Maximum plasma concentrations of varenicline occur typically within 3-4 hours after oral administration.
Il- konċentrazzjonijiet massimi ta 'varenicline fil- plasma ġeneralment iseħħu 3- 4 sigħat wara li jingħata mill- ħalq.
Following administration of multiple oral doses to healthy volunteers, steady- state conditions were reached within 4 days.
Wara l- amministrazzjoni orali ta 'dożi multipli lil voluntiera b' saħħithom, kondizzjonijiet stabbli kienu miksuba fi żmien 4 ijiem.
Absorption is virtually complete after oral administration
L- assorbiment wara amministrazzoni orali huwa prattikament komplet u d- disponibilita 'sistemika hija għolja.
Oral bioavailability of varenicline is unaffected by food or time-of- day dosing.
Il- bijodisponibilita 'orali ta' varenicline mhix affettwata mill- ikel jew mill- ħin li tingħata d- doża.
Varenicline distributes into tissues, including the brain.
Varenicline jitqassam fit- tessuti, inkluż il- moħħ.
Apparent volume of distribution averaged 415 litres (%CV= 50) at steady-state.
Il- volum apparenti tad- distribuzzjoni kien bħala medja 415- il litru (% CV=50) fl- istat stabbli.
Plasma protein binding of varenicline is low (< 20%) and independent of both age and renal function.
It- tqabbid ta 'varenicline mal- proteini tal - plasma hu baxx (< 20%) u indipendenti kemm mill- eta' kif ukoll mill- funzjoni tal- kliewi.
In rodents, varenicline is transferred through the placenta and excreted in milk.
Fl- annimali gerriema, varenicline jiġi trasferit minn ġol- plaċenta u joħroġ fil- ħalib.
Biotransformation:
Bijotrasformazzjoni:
Varenicline undergoes minimal metabolism with 92% excreted unchanged in the urine and less than 10% excreted as metabolites.
Varenicline jiġi sottopost għal metaboliżmu minimu bi 92% tad- doża jitneħħa mhux modifikat fl- awrina u anqas minn 10% jitneħħa bħala metaboliti.
Minor metabolites in urine include varenicline N- carbamoylglucuronide and hydroxyvarenicline.
Il- metaboliti minuri fl- awrina jinkludu varenicline N- carbamoylglucuronide u hydroxyvarenicline.
In circulation, varenicline comprises 91% of drug- related material.
Fiċ- ċirkolazzjoni, varenicline jiġbor 91% tal- materjal relatat mal- mediċina.
Minor circulating metabolites include varenicline N-carbamoylglucuronide and N- glucosylvarenicline.
Il- metaboliti minuri fiċ- ċirkolazzjoni jinkludu varenicline N- carbamoylglucuronide u N- glucosylvarenicline.
The elimination half-life of varenicline is approximately 24 hours.
Il- half life ta 'l- eliminazzjoni ta' varenicline hi bejn wieħed u ieħor 24 siegħa.
Renal elimination of varenicline is primarily through glomerular filtration along with active tubular secretion via the organic cationic transporter, OCT2.
L - eliminazzjoni ta 'varenicline mill- kliewi ssir prinċipalment permezz ta' filtrazzjoni glomerulari flimkien ma 'sekrezzjoni tubulari attiva permezz tat- trasportatur katjoniku organiku, OCT2.
(see section 4.5).
(ara sezzjoni 4. 5).
Linearity/ Non linearity:
Lineari/ Mhux lineari:
Varenicline exhibits linear kinetics when given as single (0.1 to 3 mg) or repeated 1 to 3 mg/ day) doses.
Varenicline jippreżenta kinetiċi lineari meta jingħata bħala doża waħda (0. 1 sa 3 mg) jew f' dożi ripetuti (minn 1 sa 3 mg/ ġurnata).
Pharmacokinetics in special patient populations:
Farmakokinetiċi f' popolazzjonijiet speċjali ta 'pazjenti:
There are no clinically meaningful differences in varenicline pharmacokinetics due to age, race, gender, smoking status, or use of concomitant medications, as demonstrated in specific pharmacokinetic studies and in population pharmacokinetic analyses.
M' hemmx differenzi klinikament sinifikanti fil- farmakokinetiċi ta 'varenicline b' rabta ma' l- eta ', ir- razza, is- sess tal- persuna, l- abitudni tat- tipjip jew l- użu ta' mediċini konkomitanti, kif muri fi studji speċifiċi ta 'farmakokinetika u f' analiżi farmakokinetiċi tal- popolazzjoni.
Patients with hepatic impairment:
Pazjenti b' indeboliment tal- fwied:
Due to the absence of significant hepatic metabolism, varenicline pharmacokinetics should be unaffected in patients with hepatic impairment.
Minħabba n- nuqqas ta 'metaboliżmu epatiku sinifikanti, il - farmakokinetiċi ta' varenicline ma għandhomx jiġu affettwati f' pazjenti b' indeboliment tal- fwied.
(see section 4.2).
(ara sezzjoni 4. 2).
Renal Insufficiency:
Insuffiċjenza tal- kliewi:
Varenicline pharmacokinetics were unchanged in subjects with mild renal impairment (estimated creatinine clearance > 50 ml/ min and ≤ 80 ml/ min).
Il- farmakokinetiċi ta 'varenicline ma kinux modifikati f' suġġetti b' indeboliment ħafif tal- kliewi (clearance stmata tal- kreatinina > 50 ml/ min u ≤80 ml/ min).
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).
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 'suġġetti b' funzjoni tal- kliewi normali (clearance stmata tal- kreatinina > 80 ml/ min).
In subjects with severe renal impairment (estimated creatinine clearance < 30 ml/ min), varenicline exposure was increased 2.1-fold.
F' suġġetti b' indeboliment sever tal- kliewi (clearance stmata tal- kreatinina < 30 ml/ min), l- espożizzjoni għal varenicline żdiedet bi 2. 1 drabi.
In subjects with end-stage-renal disease (ESRD), varenicline was efficiently removed by haemodialysis (see section 4.2).
F' suġġetti li kienu fl- aħħar stadju tal- mard tal- kliewi (ESRD), varenicline ġie mneħħi b' mod effiċjenti permezz ta 'ħemodijaliżi (ara sezzjoni 4. 2).
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).
Il- farmakokinetika ta 'varenicline f' pazjenti anzjani b' funzjoni tal- kliewi normali (eta' 65- 75 sena) hi simili għal dik ta 'suġġetti adulti iżgħar (ara sezzjoni 4. 2).
For elderly patients with reduced renal function please refer to section 4.2.
Għal pazjenti anzjani b' funzjoni tal- kliewi mnaqqsa jekk jogħġbok irreferi għal sezzjoni 4. 2.
Adolescents:
Adoloxxenti:
When 22 adolescents aged 12 to 17 years (inclusive) received a single 0.5 mg and 1 mg dose of varenicline the pharmacokinetics of varenicline was approximately dose proportional between the 0.5 mg and 1 mg doses.
Meta 22 adoloxxent/ a bejn 12 u 17- il sena (inklużi) rċevew doża waħda ta '0. 5 mg u 1 mg ta' varenicline, il- farmakokinetika ta 'varenicline kienet bejn wieħed u ieħor proporzjonali għad - doża bejn id- dożi ta' 0. 5 mg u 1 mg.
Systemic exposure, as assessed by AUC (0-inf), and renal clearance of varenicline were comparable to adults.
L- espożizzjoni sistemika, kif valutata bl- AUC (0- inf), u l - clearance renali ta 'varenicline kienu paragunabbli għal dawk ta' l- adulti.
An increase of 30% in Cmax and a shorter elimination half-life (10.9 hr) were observed in adolescents compared with adults (see section 4.2).
Fl- adoloxxenti kienet osservata żieda ta '30% fil- Cmax u half- life iqsar ta' l- eliminazzjoni (10. 9 sigħat) meta mqabbel ma 'l - adulti (ara sezzjoni 4. 2).
In vitro studies demonstrate that varenicline does not inhibit cytochrome P450 enzymes (IC50 > 6,400 ng/ ml).
9 L- istudju in vitro juru li varenicline ma jinibixxix l- enzimi taċ- ċitokromu P450 (IC50 > 6, 400 ng/ ml).
The P450 enzymes tested for inhibition were:
L- enzimi P450 ittestjati għall- inibizzjoni kienu:
1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/ 5.
1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, u 3A4/ 5.
Also, in human hepatocytes in vitro, varenicline was shown to not induce the activity of cytochrome P450 enzymes 1A2 and 3A4.
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.
Therefore, varenicline is unlikely to alter the pharmacokinetics of compounds that are primarily metabolised by cytochrome P450 enzymes.
Għalhekk, varenicline mhux probabbli li jbiddel il- farmakokinetiċi ta 'komposti li jiġu metabolizzati prinċipalment minn enzimi taċ- ċitokromu P450.
9 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
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.
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.
In male rats dosed for 2 years with varenicline, there was a dose-related increase in the incidence of hibernoma (tumour of the brown fat).
Fil- firien irġiel li ngħataw dożi ta 'varenicline għal sentejn, kien hemm żieda relatata mad- doża fl- inċidenza ta' ibernoma (tumur tax- xaħam kannella).
In the offspring of pregnant rats treated with varenicline there were decreases in fertility and increases in the auditory startle response (see section 4.6).
Fil- frieħ ta 'firien tqal ikkurati b' varenicline kien hemm tnaqqis fil- fertilita' u żidiet fir- rispons ta 'ħasda għall- ħoss (ara sezzjoni 4. 6).
These effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Dawn l- effetti ġew osservati biss f' espożizzjonijiet meqjusa suffiċjentement akbar mill - espożizzjoni massima fil- bniedem u b' hekk għandhom rilevanza skarsa għall- użu kliniku.
Nonclinical data indicate varenicline has reinforcing properties albeit with lower potency than nicotine.
Informazzjoni mhux klinika tindika li varenicline għandu kwalitajiet rinforzanti għalkemm anqas qawwija min- nikotina.
In clinical studies in humans, varenicline showed low abuse potential.
Fl- istudji kliniċi fuq il- bniedem, varenicline wera potenzjal baxx ta 'abbuż.
Core Tablet
Qalba tal- Pillola
Cellulose, Microcrystalline Calcium Hydrogen Phosphate Anhydrous Croscarmellose Sodium Silica, Colloidal Anhydrous Magnesium Stearate
Cellulose, Microcrystalline Calcium Hydrogen Phosphate Anhydrous Croscarmellose Sodium Silica, colloidal anhydrous Magnesium Stearate
Film Coating
Kisja tar- Rita
Hypromellose Titanium Dioxide (E171) Macrogols Triacetin
Hypromellose Titanium Dioxide (E171) Macrogols Triacetin
This medicinal product does not require any special storage conditions
Dan il- prodott mediċinali ma jeħtieġx kondizzjonijiet speċjali għall- ħażna.
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
Treatment initiation packs Aclar / PVC / blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg film- coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Pakketti għall- bidu tal- kura Folji ta 'l- Aclar / PVC b' rinforz ta' folja ta 'l- aluminju li fihom folja waħda trasparenti ta' 11 x 0. 5 mg pillola miksija b' rita u folja oħra trasparenti ta '14 x 1 mg pillola miksija b' rita f' pakkett sekondarju tal - kartun issiġillat bis- sħana.
Aclar / PVC / blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg film- coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
10 Folji ta 'l- Aclar / PVC b' rinforz ta' folja ta 'l- aluminju li fihom folja waħda trasparenti ta' 11 x 0. 5 mg pillola miksija b' rita u folja oħra trasparenti li fiha 14 x 1 mg pillola miksija b' rita f' kaxxa.
10 Aclar / 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 a second clear blister of 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Folji ta 'l- Aclar / PVC b' rinforz ta' folja ta 'l- aluminju li fihom folja waħda trasparenti ta' 11 x 0. 5 mg u 14 x 1 mg pilloli miksija b’ rita u folja oħra trasparenti ali fiha 28 x 1 mg pilloli miksija b’ rita f’ pakkett sekondarju tal- kartun issiġillat bis- sħana.
Maintenance packs Aclar / PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Pakketti ta 'manteniment Folji ta' l- Aclar / 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.
Aclar / PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Folji ta 'l- Aclar / 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.
High-density polyethylene (HDPE) blue white tablet container with polypropylene child resistant closure and an aluminium foil / polyethylene induction seal containing 56 x 0.5 mg film-coated tablets
Kontenitur għall- pilloli magħmul minn politin ta 'densita' għolja (HDPE) ta 'lewn abjad kaħlani b' għeluq tal- polipropelin reżistenti għat- tfal u induction seal magħmul minn folja ta' l- aluminju / politin li fih 56 x 0. 5 mg pillola miksija b' rita.
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK
Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ Ir- Renju Unit
CHAMPIX 1 mg film-coated tablets
CHAMPIX 1 mg pilloli miksijin b' rita
Each film-coated tablet contains 1 mg of varenicline (as tartrate).
Kull pillola miksija b' rita fiha 1 mg ta 'varenicline (bħala tartrat).
1 mg film-coated tablets:
Pilloli ta '1 mg miksijin b' rita:
Light blue, capsular-shaped, biconvex tablets debossed with “ Pfizer ” on one side and “ CHX 1.0” on the other side.
Pilloli ta 'lewn ikħal ċar, bikonvessi, forma ta' kapsula, bi “ Pfizer ” imnaqqxa fuq naħa u “ CHX 1. 0 ” fuq in- naħa l- oħra.
12 In smoking cessation therapy, risk for relapse to smoking is elevated in the period immediately following the end of treatment.
12 Fit- terapija għal waqfien mit- tipjip, ir- riskju ta 'rikaduta għat- tipjip huwa għoli fil- perjodu immedjatament wara t- tmiem tal- kura.
Patients with renal insufficiency 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.
Pazjenti b' insuffiċjenza tal- kliewi M' hemmx bżonn aġġustament fid- doża għal pazjenti b' indeboliment tal- kliewi ħafif (tneħħija stmata tal- kreatinina > 50 ml/ min u ≤80 ml/ min) għal moderat (tneħħija stmata tal- kreatinina ≥30 ml/ min u ≤50 ml/ min).
For patients with severe renal impairment (estimated creatinine clearance < 30 ml/ min), the recommended dose of CHAMPIX is 1 mg once daily.
Għall- pazjenti b' indeboliment akut tal- kliewi (tneħħija stmata tal- kreatinina < 30 ml/ min), id- doża rakkomandata ta 'CHAMPIX hi 1 mg darba kuljum.
Not all patients had stopped smoking at the time of onset of symptoms and not all patients had known pre-existing psychiatric illness.
Mhux il- pazjenti kollha kienu waqqfu mit- tipjip fiż- żmien li bdew jidhru is- sintomi u mhux il- pazjenti kollha kellhom xi mard psikjatriku ġa eżistenti.
Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nictotine withdrawal.
Burdati dippressivi, li rarament jinkludu ideat ta ’ suwiċidju u attentati ta ’ suwiċidju, jisgħu ikunu sintomu ta ’ twaqqif tan- nikotina.
In addition, smoking cessation, with or without pharmacotherapy, has been associated with the exacerbation of underlying psychiatric illness (e. g. depression).
Dipressjoni).
13 The safety and efficacy of Champix in patients with serious psychiatric illness such as schizophrenia, bipolar disorder and major depressive disorder has not been established.
13 Is- sigurta ’ u l- effikaċja ta ’ Champix f’ pazjenti b’ mard psikjatriku serju, bħal skizofrenija, episodji ta ’ manija jalternaw ma ’ burdati dipressivi (bipolar disorder), u marda ta ’ dipressjoni akuta ma ġewx stabilizzati.
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.
Barra minn hekk, billi l- metaboliżmu ta 'varenicline jirrappreżenta anqas minn 10% ta' l- eliminazzjoni tiegħu, sustanzi attivi magħrufa li jaffettwaw is- sistema taċ- ċitokromu P450 mhumiex probabbli li jbiddlu l- farmakokinetiċi ta 'varenicline (ara sezzjoni 5. 2) u għalhekk m' għandux ikun meħtieġ aġġustament fid- doża ta' CHAMPIX.
Co-administration of cimetidine, with varenicline increased the systemic exposure of varenicline by 29% due to a reduction in varenicline renal clearance.
L- amministrazzjoni ta 'cimetidine ma' varenicline żiedet l- espożizzjoni sistemika ta 'varenicline b' 20% minħabba tnaqqis fl- eliminazzjoni renali ta' varenicline.
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.
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.
In this study, the incidence of nausea, headache, vomiting, dizziness, dyspepsia, and fatigue was greater for the combination than for NRT alone.
F' dan l- istudju, l- inċidenza
14 4.6 Pregnancy and lactation
14 tad- dardir, uġigħ ta 'ras, rimettar, sturdament, dispepsja, u għeja kienet akbar għall- kombinazzjoni milli għan- NRT waħedha.
Studies in animals have shown reproductive toxicity (see section 5.3).
L- istudji fuq l- annimali wrew tossiċita 'tas- sistema riproduttiva (ara sezzjoni 5. 3).
15
15 Sistema tal - Klassifika ta 'l - Organi
Nausea Vomiting, constipation, diarrhoea, abdominal distension, stomach discomfort, dyspepsia, flatulence, dry mouth
Nawsja Rimettar, stitikezza, dijarea, distensjoni addominali, diqa fl- istonku, dispepsja, gass fl- istonku, ħalq xott
16 4.9 Overdose
16
In case of overdose, standard supportive measures should be instituted as required.
F' każ ta 'doża eċċessiva, għandhom jiddaħħlu miżuri standard ta' sostenn kif ikun meħtieġ.
The primary endpoint of the two studies was the carbon monoxide (CO) confirmed, 4-week continuous quit rate (4W-CQR) from week 9 through week 12.
17 L- endpoint primarju taż- żewġ studji kien ir- rata ta 'waqfien kontinwu ta' 4 ġimgħat (4W- CQR) mid- 9 sat- 12- il ġimgħa, ikkonfermata mil- livell tal- monossidu karboniku (CO).
CA was defined as the proportion of all subjects treated who did
Wara l- fażi ta '40 ġimgħa mingħajr kura, endpoint sekondarju importanti għaż- żewġ studji kienet ir - Rata ta' Astinenza Kontinwa (CA) fit- 52 ġimgħa.
17 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.
Il- CA ġiet definita bħala l- proporzjoni tas- suġġetti kkurati kollha li ma pejpux (lanqas nifs wieħed ta 'sigarrett) minn Ġimgħa 9 sa Ġimgħa 52 u li ma kellhomx kejl ta' CO minfuħ 'il barra ta' > 10 ppm.
Patient reported craving, withdrawal and reinforcing effects of smoking Across both Studies 1 and 2 during active treatment, craving and withdrawal were significantly reduced in patients randomized to CHAMPIX in comparison with placebo.
Pazjenti li rrapportaw effetti tax- xenqa, irtirar u rinforz tat- tipjip Fiż- żewġ Studji 1 u 2 matul il- kura attiva, ix- xenqa u l- astinenza mit- tipjip naqsu b' mod sinifikanti fil - pazjenti magħżula b' mod każwali għal CHAMPIX meta mqabbel mal- plaċebo.
The effect of varenicline on craving, withdrawal and reinforcing effects of smoking were not measured during the non-treatment long-term follow-up phase.
L- effett ta 'varenicline fuq l- effetti tax - xenqa, l- irtirar u r- rinforz tat- tipjip ma kinux imkejla waqt il- fażi ta' wara fuq perjodu fit- tul mingħajr kura.
5.2 Pharmacokinetic properties
18 5. 2 Tagħrif farmakokinetiku
Following administration of multiple oral doses to healthy volunteers, steady-
Wara l- amministrazzjoni orali ta 'dożi multipli lil voluntiera b' saħħithom, kondizzjonijiet stabbli kienu miksuba fi żmien 4 ijiem.
Absorption is virtually complete after oral administration and systemic availability is high.
L- assorbiment wara amministrazzoni orali huwa prattikament komplet u d- disponibilita 'sistemika hija għolja.
In vitro studies demonstrate that varenicline does not inhibit cytochrome P450 enzymes (IC50 > 6,400 ng/ ml).
19 L- istudju in vitro juru li varenicline ma jinibixxix l- enzimi taċ- ċitokromu P450 (IC50 > 6, 400 ng/ ml).
19 5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Hypromellose Titanium Dioxide (E171) Macrogols Indigo Carmine Aluminium Lake E132 Triacetin
Hypromellose Titanium Dioxide (E171) Macrogols Indigo Carmine Aluminium Lake E132 Triacetin
6.5 Nature and contents of container
20 6. 5 In- natura tal- kontenitur u ta 'dak li hemm ġo fih
Aclar / PVC / blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg film- coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Folji ta 'l- Aclar / PVC b' rinforz ta' folja ta 'l- aluminju li fihom folja waħda trasparenti ta' 11 x 0. 5 mg pillola miksija b' rita u folja oħra trasparenti li fiha 14 x 1 mg pillola miksija b' rita f' kaxxa.
20 Aclar / 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 a second clear blister of 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Folji ta 'l- Aclar / PVC b' rinforz ta' folja ta 'l- aluminju li fihom folja waħda trasparenti ta' 11 x 0. 5 mg u 14 x 1 mg pilloli miksija b’ rita u folja oħra trasparenti li fiha 28 x 1 mg pilloli miksija b’ rita f’ pakkett sekondarju tal- kartun issiġillat bis- sħana.
Maintenance packs Aclar / PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Pakketti ta 'manteniment Folji ta' l- Aclar / PVC b' rinforz ta 'folja ta' l- aluminju f' pakkett li fih 28 x 1 mg pillola miksija b' rita f' pakkett sekondarju tal- kartun issiġillat bis- sħana.
Aclar / PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Folji ta 'l- Aclar / 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.
Aclar / PVC / blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Folji ta 'l- Aclar / PVC b' rinforz ta' folja ta 'l- aluminju f' pakkett li fih 28 x 1 mg pillola miksija b' rita f' kaxxa.
Aclar / PVC / blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Folji ta 'l- Aclar / PVC b' rinforz ta' folja ta 'l- aluminju f' pakkett li fih 56 x 1 mg pillola miksija b' rita f' kaxxa.
Aclar / PVC / blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
Folji ta 'l- Aclar / PVC b' rinforz ta' folja ta 'l- aluminju f' pakkett li fih 112 x 1 mg pillola miksija b' rita f' kaxxa.
High-density polyethylene (HDPE) blue white tablet container with polypropylene child resistant closure and an aluminium foil / polyethylene induction seal containing 56 x 1 mg film-coated tablets
Kontenitur għall- pilloli magħmul minn politin ta 'densita' għolja (HDPE) ta 'lewn abjad kaħlani b' għeluq tal- polipropelin reżistenti għat- tfal u induction seal magħmul minn folja ta' l- aluminju / politin li fih 56 x 1 mg pillola miksija b' rita.
EU/ 1/ 06/ 360/ 003 EU/ 1/ 06/ 360/ 008 EU/ 1/ 06/ 360/ 012 EU/ 1/ 06/ 360/ 004 EU/ 1/ 06/ 360/ 005 EU/ 1/ 06/ 360/ 009 EU/ 1/ 06/ 360/ 010 EU/ 1/ 06/ 360/ 011 EU/ 1/ 06/ 360/ 002
21 EU/ 1/ 06/ 360/ 004 EU/ 1/ 06/ 360/ 005 EU/ 1/ 06/ 360/ 009 EU/ 1/ 06/ 360/ 010 EU/ 1/ 06/ 360/ 011 EU/ 1/ 06/ 360/ 002
22 A.
22 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA 'L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Pfizer Manufacturing Deutschland GmbH Heinrich-Mack-Strasse 35 D-89257 Illertissen Germany
Pfizer Manufacturing Deutschland GmbH Heinrich- Mack- Strasse 35 D- 89257 Illertissen Il- Ġermanja
• OTHER CONDITIONS
• KONDIZZJONIJIET OĦRA
Pharmacovigilance system
Sistema ta 'Farmakoviġilanza
The MAH must ensure that the system of pharmacovigilance, as described in Version 1.1 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għandu jassigura li s- sistema ta ’ famakoviġilanza, kif deskritta fil- verżjoni 1. 1 ippreżentata f’ Modulu 1. 8. 1 ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, hija kif għandha tkun u taħdem tajjeb waqt li l- prodott ikun fis- suq.
Risk Management Plan
Il- Pjan Dwar l- Immaniġġar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.0 (25 June 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jikkommetti ruħu sabiex iwettaq l- istudji u l - attivitajiet farmakoviġilanti addizzjonali li jinsabu imniżżla fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif mifthiem f’ verżjoni 3. 0 (25 ta ’ Ġunju 2008) tal- Pjan Dwar l- Immaniġġar tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u aġġornamenti sussegwenti oħra ta ’ l- RMP aċċettati mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHMP li tittratta dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskju għal prodotti mediċinali magħmula għall- użu mill- bniedem, il- RMP aġġornat għandu jiġi ssottomess flimkien mar - Rapport Perjodiku ta’ Aġġornamenti dwar is- Sigurtà (PSUR).
In addition, an updated RMP should be submitted
Barra minn dan, għandu jiġi ssottomess RMP aġġornat
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
•
23 ANNEX III
meta jkun hemm informazzjoni ġdida li tista ’ taffetwa l- Ispeċifikazzjoni dwar is- Sigurtà aġġornata applikabbli, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet relatati mat- tnaqqis tar- riskju
LABELLING AND PACKAGE LEAFLET
• fi żmien 60 ġurnata mid- data meta jseħħ avveniment importanti (relatat ma ’ farmakoviġilanza jew ma ’ tanqqis tar- riskju) • fuq talba ta ’ l- EMEA
24 A.
24 ANNESS III
25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
2-week treatment initiation pack Heat sealed card pack containing 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 – inner and outer labelling
Pakkett għall- bidu tal- kura ta ’ ġimgħatejn Pakkett tal- kartun issiġillat bis- sħana 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 - tikketta ta 'ġewwa u ta' barra
CHAMPIX 0.5 mg and 1 mg film-coated tablets Varenicline
CHAMPIX 0. 5 mg u 1 mg pilloli miksijin b' rita Varenicline
Each tablet contains 0.5 mg or 1 mg varenicline (as tartrate).
Kull pillola fiha 0. 5 mg jew 1 mg varenicline (bħala tartrat).
Film-coated tablets 11 x 0.5 mg and 14 x 1 mg
Pilloli miksijin b' rita 11 x 0. 5 mg u 14 x 1 mg
Oral use.
Jittieħed mill- ħalq.
Do not use if box has been opened
Tużahx jekk il- kaxxa tkun miftuħa
KEEP THE PACKAGE INTACT
ŻOMM IL- PAKKETT INTATT
MM/ YYYY
XX/ SSSS
Pfizer Limited Sandwich Kent CT13 9NJ United Kingdom
Pfizer Limited Sandwich Kent CT13 9NJ Renju Unit
START AT DAY 1 The day I stop smoking should be between day 8 and day 14.
IBDA FL- EWWEL JUM Il- ġurnata meta nieqaf inpejjep għandha tkun bejn jum 8 u jum 14.
The day I stop smoking will be ______________.
Il- ġurnata meta se nieqaf inpejjep se tkun ______________.
Week 1 Week 2
L- ewwel ġimgħa It- tieni ġimgħa
Numbers 1 to 14 sun as symbol moon as symbol
Numru 1 sa 14 simbolu tax- xemx simbolu tal- qamar
CHAMPIX 0.5 mg 1 mg
CHAMPIX 0. 5 mg 1 mg
27 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
28 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister Pack of 11 x 0.5 mg varenicline film-coated tablets, Heat Sealed Card
Pakkett Folji ta '11 x 0. 5 mg varenicline pilloli miksijin b' rita, Kartuna Issiġillata bis- Sħana
CHAMPIX 0.5 mg Varenicline
CHAMPIX 0. 5 mg Varenicline
Pfizer Ltd (as MA Holder Logo)
Pfizer Ltd (bħala lowgo tad- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq)
28 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
29 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister Pack of 14 x 1 mg varenicline film-coated tablets, Heat Sealed Card
Pakkett Folji ta '14 x 1 mg varenicline pilloli miksijin b' rita, Kartuna Issiġillata bis- Sħana
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
30 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
4-week treatment initiation pack 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 x 1 mg varenicline film-coated tablets – inner and outer labelling
Pakkett għall- bidu tal- kura ta ’ 4 ġimgħat Pakkett tal- kartun issiġillat bis- sħana li fih pakkett folji ta '11 x 0. 5 mg u 14 x 1 mg varenicline pilloli miksijin b' rita u pakkett folji ta' 28 x 1 mg varenicline pilloli miksijin b' rita - tikketta ta 'ġewwa u ta' barra
CHAMPIX 0.5 mg CHAMPIX 1 mg FILM-COATED TABLETS Varenicline
CHAMPIX 0. 5 mg CHAMPIX 1 mg Pilloli miksijin b' rita Varenicline
4-week treatment initiation pack containing:
Pakkett ta ’ kura inizzjali għal 4 ġimgħat li fih:
11 x 0.5 mg Film-coated tablets and 42 x 1 mg Film-coated tablets
11 x 0. 5 mg Pilloli miksijin b' rita u 42 x 1 mg Pilloli miksijin b' rita
Week 1 Week 2 Week 3 Week 4
L- ewwel ġimgħa It- tieni ġimgħa It- tielet ġimgħa Ir- raba ’ ġimgħa
Numbers 1 to 28 sun as symbol moon as symbol
Numru 1 sa 14 simbolu tax- xemx simbolu tal- qamar
31 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister Pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets, Heat Sealed Card
Pakkett Folji ta '11 x 0. 5 mg u 14 x 1mg varenicline pilloli miksijin b' rita, Kartuna Issiġillata bis - Sħana
CHAMPIX 0.5 mg CHAMPIX 1 mg Varenicline
CHAMPIX 0. 5 mg CHAMPIX 1 mg Varenicline
32 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blister Pack of 28 x 1 mg varenicline film-coated tablets, Heat Sealed Card
Pakkett Folji ta '28 x 1mg varenicline pilloli miksijin b' rita, Kartuna Issiġillata bis- Sħana
Maintenance pack Heat sealed card pack containing either 2 blister packs of 14 x 1 mg varenicline film-coated tablets or 2 blister packs of 28 x 1 mg varenicline film-coated tablets– inner and outer labelling
Pakkett ta 'manteniment Pakkett tal- kartun issiġillat bis- sħana li fih jew żewġ pakketti ta' folji ta '14 x 1 mg varenicline pilloli miksijin b' rita jew 2 pakketti ta' folji ta '28 x 1 mg varenicline pilloli miksijin b' rita - tikketta ta' ġewwa u ta 'barra
CHAMPIX 1 mg film-coated tablets Varenicline
Champix 1 mg pilloli miksijin b' rita Varenicline
Each tablet contains 1 mg varenicline (as tartrate).
Kull pillola fiha 1 mg varenicline (bħala tartrat).
28 film-coated tablets 56 film-coated tablets
28 pillola miksijin b' rita 56 pillola miksijin b' rita