qanastek/EMEA-V3 huggingface dataset:
ACOMPLIA is a medicine containing the active substance rimonabant.
ACOMPLIA hija mediċina li fiha s- sustanza attiva rimonabant.
It is available as white, teardrop- shaped tablets. no
Hija tiġi bħal pilloli bojod f’ forma ovali. m ’
What is ACOMPLIA used for?
Għal xiex tintuża ACOMPLIA?
ACOMPLIA is used together with diet and exercise to treat adult patients: • who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/ m², • who are overweight (with a BMI greater than or equal to 27 kg/ m²) and also have other risk factors, ct
ACOMPLIA tintuża flimkien ma ’ dieta u eżerċizzju biex tikkura pazjenti adulti: • Li għandhom piż eċċessiv (ħafna piż żejjed) b’ indiċi tal- massa korporja (BMI) akbar minn jew daqs 30kg/ m², li li
such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in their blood).
• Li għandhom piż żejjed (b ’ BMI akbar minn jew daqs 27kg/ m²) u li għandhom ukoll fatturi ta ’ riskju oħra, bħal ma huma dijabete tip 2 u dislipidimja (livelli mhux normali ta ’ xaħmijiet fid- demm tagħhom). ina
The medicine can only be obtained with a prescription. du
Il- mediċina tista ’ tinkiseb biss permezz ta ’ riċetta ta ’ tabib.
How is ACOMPLIA used?
Kif tintuża ACOMPLIA?
ACOMPLIA is taken as one tablet once a day, before breakfast.
ACOMPLIA tittieħed bħala pillola waħda darba kuljum, qabel il- kolazzjon.
The patients should also follow a reduced calorie diet and increase their level of physical activity.
Il- pazjenti għandhom ukoll isegwu dieta ta ’ kaloriji mnaqqsa u jżidu l- livell ta ’ l- attività fiżika tagħhom.
The medicine should not be used in patients who ro
Il- mediċina m’ għandhiex diċ
have severe problems with their liver or their kidneys. lp
tintuża f’ pazjenti li għandhom problemi severi bil- fwied jew bil- kliewi tagħhom.
How does ACOMPLIA work?
Kif taħdem ACOMPLIA?
The active substance in ACOMPLIA, rimonabant, is a cannabinoid receptor antagonist.
Hija taħdem billi me
It acts by blocking a specific type of receptor, the cannabinoid type 1 (CB1) receptors.
timblokka tip speċifiku ta ’ riċettur, ir- riċetturi kannabinojde (CB1) tip 1.
The receptors are ina
Dawn ir- riċetturi jinsabu fis - sistema nervuża, u huma parti mis- sistema li l- ġisem juża biex jikkontrolla t- teħid ta ’ l- ikel.
also found in adipocytes (fat tissue).
Ir- riċetturi jinsabu ukoll fl- adipoċiti (tessut tax- xaħam).
How has ACOMPLIA been studied?
Kif ġiet studjata ACOMPLIA?
The effects of ACOMPLIA were first tested in experimental models before being studied in humans. dic
L- effetti ta ’ ACOMPLIA kienu l- ewwel ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil - ott
Four studies of ACOMPLIA in overweight and obese patients were carried out, involving almost 7,000 patients, whose weight at the start of the studies was on average 94 to 104 kg.
Saru erba ’ studji ta ’ ACOMPLIA f’ pazjenti b’ piż żejjed u piż eċċessiv, li involvew kważi 7, 000 pazjent, li l- piż tagħhom fil- bidu ta ’ l- istudji kien medja ta ’ 94 sa 104kg.
The Me
Studju wieħed ħares b’ mod partikolari aktar d
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged studies compared the effect of ACOMPLIA with that of a placebo (a dummy treatment) on weight loss
E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged at izz lejn pazjenti b’ livelli mhux normali ta ’ xaħmijiet fid- demm, u wieħed lejn pazjenti b’ dijabete ta ’ tip 2.
d over one to two years.
Studju wieħed ħares kif dan it- telf jista ’ jkun miżmum waqt it- tieni sena.
One study also looked at how this loss could be maintained during the second year.
Saru ukoll erba ’ studji ta ’ ACOMPLIA bħala għajnuna biex jieqaf it- tipjip f’ aktar minn 7, 000 pazjent, u
ise Four studies of ACOMPLIA as a help to stop smoking were also carried out in over 7,000 patients, comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one of the studies) on smoking cessation, and on relapses in the following year.
tor qabbluha ma ’ plaċebo, u kejlu l- effett tal- mediċina mogħtija għal 10 ġimgħat (sena f’ wieħed mill- istudji) fuq it- twaqqif tat- tipjip, u fuq rikaduti fis- sena segwenti.
or What benefit has ACOMPLIA shown during the studies?
X’ benefiċċju wriet ACOMPLIA waqt l- istudji?
After one year, all patients who received ACOMPLIA lost more weight than those who received placebo: they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the
aw Wara sena, il- pazjenti kollha li rċievew ACOMPLIA tilfu aktar piż milli dawk li rċievew plaċebo: tilfu medja ta ’ 4. 9kg aktar minn plaċebo, ħlief fl- istudju f’ pazjenti dijabetiċi, fejn id- differenza fit- telf tal- piż kienet 3. 9kg.
The medicine also reduced the risk of regaining weight.
Il- mediċina naqqset ukoll ir- riskju ta ’ żieda ta ’ piż mill- ġdid.
The studies in smoking cessation did not show consistent results, and the effect of ACOMPLIA in this area was difficult to estimate.
L- istudji tat- twaqqif mit- tipjip ma wrewx riżultati konsistenti, u l- effett ta ’ ACOMPLIA f’ dan il- qasam kien diffiċli biex tistmah.
The company decided to withdraw its application for smoking cessation.
Il- kumpanija iddeċiediet li tirtira l- applikazzjoni tagħha għal twaqqif tat- tipjip.
Therefore, ACOMPLIA is not recommended as an aid for smoking cessation
ux Għaldaqstant, ACOMPLIA mhix irrikkmandata bħala għajnuna għat- twaqqif tat- tipjip.
ra What is the risk associated with ACOMPLIA?
X’ inhu r- riskju assoċjat ma ’ ACOMPLIA?
For the full list of all side effects
Waqt l- istudji, l- aktar effetti sekondarji komuni b’ ACOMPLIA (dehru f’ aktar minn pazjent 1 minn kull
ge reported with ACOMPLIA, see the Package Leaflet.
Għal- lista sħiħa ta ’ l - effetti sekondarji kollha irrapportati b’ ACOMPLIA, ara l- Fuljett ta ’ Tagħrif.
ACOMPLIA should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the other ingredients, or in women who are breast feeding.
ACOMPLIA m’ għandhiex tintuża f’ pazjenti li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal rimonabant jew għal xi sustanzi oħra tiegħu, jew f’ nisa li qed ireddgħu.
It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of lon depression, including thoughts about suicide in a small minority of patients.
Ma tistax tintuża f’ pazjenti b’ depressjoni għ maġġura li għada fuqhom jew li jkunu qed jiġu ikkurati b ’ antidepressanti, peress li tista ’ żżid ir- riskju ta ’ depressjoni, inklużi ħsibijiet dwar suwiċidju f’ minoranza żgħira ta ’ pazjenti.
Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment.
Pazjenti li jesperjenzaw sintomi ta ’ depressjoni għandhom ikellmu lit- tabib tagħhom u jistgħu jeħtieġu li jwaqqfu l- kura.
Caution should be used when taking ACOMPLIA with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics). no
Meta m ’ ACOMPLIA tittieħed ma ’ xi mediċini, bħalma huma, ketoconazole jew itraconazole (mediċini anti- fungali), ritonavir (użat f’ infezzjoni HIV), jew telithromycin jew clarithromycin (antibijotiċi), għandha tintuża l- kawtela.
Why has ACOMPLIA been approved?
Għaliex ġiet approvata ACOMPLIA? li li
The Committee for Medicinal products for Human Use (CHMP) concluded that ACOMPLIA had shown its effectiveness in weight reduction in obese or overweight patients with associated risk factors.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li ACOMPLIA wriet l - effikaċja tagħha fit- tnaqqis tal- piż f’ pazjenti b’ piż eċċessiv jew b’ piż żejjed u b’ fatturi ta ’ riskju assoċjati.
The Committee decided that ACOMPLIA’ s benefits are greater than its risks when used, in addition to diet and ct
Il- Kumitat iddeċieda li l- benefiċċji ta ’ ACOMPLIA huma akbar mir- riskji tagħha meta wżata, flimkien ma ’ dieta u eżerċizzju, biex tikkura f’ pazjenti b’ piż eċċessiv jew b’ piż żejjed b ’ fatturi ta ’ riskju bħalma ina
exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
huma dijabete tip 2 jew dislipidimja.
The Committee recommended that ACOMPLIA be given marketing authorisation. du
Il- Kumitat irrikkmanda li ACOMPLIA tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of ACOMPLIA?
X’ miżuri qed jittieħdu biex jassiguraw l- użu sigur ta ’ ACOMPLIA? diċ
patients and doctors, and to monitor how the medicine is used.
Il- kumpanija li tagħmel ACOMPLIA se tfassal programm biex tassigura li l- mediċina tintuża f’ pazjenti li għandhom bżonnha għas- saħħa, aktar milli għal raġunijiet kosmetiċi, billi tipprovdi pakketti edukattivi għall- pazjenti u għat- tobba, u tissorvelja kif tintuża l- mediċina.
The company will use specific databases to monitor ACOMPLIA’ s side effects, especially those linked to the nervous system. lp
Il- kumpanija se tuża databases speċifiċi biex tissorvelja l- effetti sekondarji ta ’ ACOMPLIA, speċjalment dawk marbuta mas- sistema nervuża. me
Other information about ACOMPLIA:
Tagħrif ieħor dwar ACOMPLIA:
The European Commission granted a marketing authorisation valid throughout the European Union for ACOMPLIA to sanofi-aventis on 19 June 2006. ina
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal ACOMPLIA valida fl- Unjoni Ewropea kollha lil sanofi- aventis fid- 19 ta ’ Ġunju 2006.
The full EPAR for ACOMPLIA can be found here.
L- EPAR sħiħ għal ACOMPLIA huwa disponibbli minn hawn. ott
This summary was last updated in 10-2007. dic Me
Dan is- sommarju ġie aġġornat l- aħħar f’ 10- 2007. d Pro
e d is EU number
at zz Numru ta ’ l- EU
Strength
G amla
Pharmaceutical Form
Mnejn jing ata
Route of
Il- pakkett
Packaging
Daqs tal- pakkett
Package size
ri farma ewtika E
or administration EU/ 1/ 06/ 344/ 001 EU/ 1/ 06/ 344/ 002
U/ 1/ 06/ 344/ 001
Film-coated tablet Film-coated tablet
U/ 1/ 06/ 344/ 002 ACOMPLIA 20 mg Pillola miksija b’ rita U
Oral use Oral use
u orali
Blister (PVC/ aluminium) Blister (PVC/ aluminium)
folji (PVC/ aluminju)
14 tablets 28 tablets
28 pillola
th EU/ 1/ 06/ 344/ 003 EU/ 1/ 06/ 344/ 004
U/ 1/ 06/ 344/ 003
Film-coated tablet Film-coated tablet
Pillola miksija b’ rita U
56 tablets 70x1 tablets
56 pillola
u EU/ 1/ 06/ 344/ 005
a EU/ 1/ 06/ 344/ 005
Film-coated tablet
Pillola miksija b’ rita U
Oral use
u orali
Blister (PVC/ aluminium)
folji (PVC/ aluminju)
84 tablets
84 pillola
a EU/ 1/ 06/ 344/ 006 EU/ 1/ 06/ 344/ 007
U/ 1/ 06/ 344/ 007
Blister (PVC/ aluminium) Bottle (HDPE)
Flixkun (HDPE)
98 tablets 28 tablets
28 pillola 98 pillola
r EU/ 1/ 06/ 344/ 008
U/ 1/ 06/ 344/ 008
Bottle (HDPE)
Flixkun (HDPE)
98 tablets
d E
e EU/ 1/ 06/ 344/ 009
U/ 1/ 06/ 344/ 009
500 tablets
500 pillola
g EU/ 1/ 06/ 344/ 010 EU/ 1/ 06/ 344/ 011
U/ 1/ 06/ 344/ 010
30 tablets 90 tablets
30 pillola 90 pillola
d
E
u
U/ 1/ 06/ 344/ 011
c
ACOMPLIA
n
Pillola miksija b’ rita U
lo
u orali
n
folji (PVC/ aluminju)
pro l i na d ic M e 1/ 1
’ g im il al in ċ di e tm t do o r P 1/ 1
SUMMARY OF PRODUCT CHARACTERISTICS no ct du ro lp ina dic Me
at izz tor aw ux ad ANNESS I għ SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT m ’ li li a iċin ed tt m do Pro
d ACOMPLIA 20 mg film-coated tablets
ACOMPLIA 20 mg pilloli miksija b’ rita
Each tablet contains 20 mg rimonabant.
at Kull pillola fiha 20 mg ta ’ rimonabant.
115 mg lactose.
izz Il- pilloli fihom madwar 115 mg tal- lattosju.
ra Film-coated tablet Biconvex, teardrop-shaped, white tablets debossed with “ 20 ” on one side.
aw Pillola miksija b’ rita Pilloli bojod, bikonvessi, taħt għamla ta ’ qatra dmugħ, bin- numru “ 20 ” imnaqqax fuq faċċata waħda.
ge 4.
ux 4.
4.1 Therapeutic indications lon As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30 kg/ m2), or overweight patients (BMI > 27 kg/ m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1). no
4. 1 Indikazzjonijiet terapewtiċi ad Bħala żieda mad- dieta u l- eżerċizzju fil- kura tal- obeżità f ’ pazjenti ħoxnin (BMI ≥ 30 kg/ m2), jew għ pazjenti qawwija (BMI > 27 kg/ m2) li għandhom ukoll fattur( i) miżjud( a) ta ’ riskju, bhad- dijabete tat - tip 2 jew livelli abnormali ta ’ xaħam fid- demm (ara sezzjoni 5. 1). m ’
In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast. ct
Fl- adulti, id- doża irrakkomandata hija ta ’ pillola waħda ta ’ 20 mg kuljum li għandha tittieħed li li
The treatment should be introduced with a mildly reduced calorie diet. du
Il- kura għandha tinbeda waqt dieta li għandha valur kalorifiku ftit imnaqqas. a
The safety and efficacy of rimonabant have not been evaluated beyond 2 years.
Is- sigurtà u l- effikaċja ta ’ rimonabant ma ġewx evalwati għal aktar minn sentejn. iċin
• Special Populations ro
• Gruppi speċjali ed
ACOMPLIA should be used with lp
M’ hemmx bżonn ta ’ aggustamenti fid- doża fl- anzjani (ara sezzjoni 5. 2).
caution in patients over 75 years of age (see section 4.4).
ACOMPLIA għandu jintuża b’ kawtela f’ pazjenti ta ’ ’ l fuq minn 75 sena (ara sezzjoni 4. 4). tt m
Patients with hepatic insufficiency: ina
Pazjenti b’ insuffiċjenza tal- fwied:
No dosage adjustment is required for patients with mild or moderate hepatic impairment.
M’ hemmx bżonn ta ’ aggustament fid- doża f’ pazjenti li għandhom insuffiċjenza ħafifa jew moderata tal- fwied.
ACOMPLIA should be used with caution in patients with moderate hepatic impairment.
ACOMPLIA għandu jintuża b’ kawtela f’ pazjenti li għandhom indeboliment moderat fil - do
ACOMPLIA should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2). dic
Pro
Patients with renal impairment:
Pazjenti b’ indeboliment renali:
No dosage adjustment is required for patients with mild and moderate renal impairment (see section 5.2).
M’ hemmx bżonn ta ’ aġġustament fid- doża f’ pazjenti li għandhom indeboliment renali ħafif għal dak moderat (ara sezzjoni 5. 2).
Me
ACOMPLIA m’ għandux jintuża f’ pazjenti li qed ibatu minn indeboliment renali sever (ara sezzjoni 4. 4 u 5. 2).
Paediatrics:
2 Tfal:
ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
ACOMPLIA mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18 il- sena peress li m’ hemmx biżżejjed informazzjoni dwar l- effikaċja u s- sigurtà.
2 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
Hypersensitivity to the active substance or to any of the excipients
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi..
d Lactation.
at It- treddigħ.
Ongoing major depressive illness and/ or ongoing antidepressive treatment (see section 4.4)
Mard depressiv sever li għadu sejjer u/ jew kura antidepressiva li għada sejra (ara sezzjoni 4. 4)
ise 4.4 Special warnings and precautions for use
izz 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
or Depressive disorders or mood alterations with depressive symptoms have been reported in up to 10%, and suicidal ideation in up to 1%, of patients receiving rimonabant (see section 4.8).
tor • Disturbi depressivi Disturbi depressivi jew bidla fil- burdata b’ sintomi depressivi kienu rrapportati sa f’ 10% u formazzjoni ta ’ idejat suwiċidali sa f’ 1% tal- pazjenti li rċevew rimonabant (ara sezzjoni 4. 8).
In patients with current suicidal ideations and/ or with a history of suicidal ideation and depressive disorder rimonabant
Rimonabant
uth should not be used unless the benefits of treatment are considered to outweigh these risks in an individual patient.
aw m’ għandux juntuża f’ pazjenti b’ formazzjoni ta ’ idejat suwiċidali kurrenti u/ jew b’ passat mediku ta’ formazzjoni ta’ idejat suwiċidali u mard depressiv sakemm il- benefiċċji tal- kura huma akbar mir - riskji f’ pazjent individwali.
(See section 4.3 and 4.8).
(Ara sezzjoni 4. 3 u 4. 8).
Obesity is a condition that can be associated with depressive disorders.
L- obesità hija kundizzjoni li tistà tkun assoċjata ma ’ disturbi depressivi.
Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.
Disturbi depressivi jistgħu jkunu assoċjati ma ’ riskju akbar ta ’ ħsibijiet
ra The prescriber should carefully investigate if the patient has had a depressive disorder in the past in order to evaluate the potential risks with rimonabant treatment.
ux suwiċidali, li l- persuna tagħmel ħsara lilha innifisha u suwiċidju.
In postmarketing experience, more than half of the patients who develop such reactions appear to do so within 1 month of starting treatment, approximately 80% appear to do so within 3 months. lon Patients should be actively monitored for signs and symptoms of psychiatric disorders, particularly depression following the start of treatment.
Min jippreskrivi għandu jistħarreġ bir- reqqa jekk il- pazjent kellhux disturbi depressivi fil- passat biex ad ikun jista ’ jevalwa r- riskju potenzjali ta ’ kura b’ rimonbant. għ Reazzjonijiet dipressivi jistgħu jseħħu f’ pazjenti li m’ għandhom ebda fatturi evidenti ta ’ riskju ħlief għall- obesità nnifisha.
The patient should be monitored and treated appropriately.
Minn esperjenza wara li l- prodott tqiegħed fis- suq jidher li iżjed minn nofs il - pazjenti li jiżviluppaw dawn ir- reazzjonijiet jagħmlu hekk fi żmien xahar li tinbeda l- kura, fi żmien 3 m ’
Patients, especially those with a history of depressive disorders/ mood alterations, (and relatives or no
Wara li tinbeda l- kura, il- pazjenti, għandhom ikunu segwiti b’ mod attiv għal sinjali u sintomi ta ’ disturbi psikjatriċi speċjalment id- dipressjoni.
other relevant persons) should be alerted about the need to monitor for the emergence of such symptoms and to seek medical advice immediately if these occur.
Il- pazjent li li
• Other psychiatric conditions ct
għandu jkun segwit u ttrattatat b’ mod xieraq.
Therapy with rimonabant is not recommended in patients with uncontrolled psychiatric illness.
Pazjenti, speċjalment dawk b’ passat mediku ta ’ disturbi depressivi/ bidla fil- burdata, (u qraba jew a
• Seizures Rimonabant has not been studied in patients being treated for epilepsy.
persuni relevanti oħra) għandhom ikunu mwissija dwar il- bżonn ta ’ ħarsien bir- reqqa għat- tfaċċar ta ’ sintomi bħal dawn u biex ifittxu immedjatament parir mediku jekk dawn jiġru. iċin
In clinical trials no difference in the incidence of seizures was seen in patients receiving rimonabant or placebo.
• Kundizzjonijiet psikjatriċi oħra Terapija b’ rimonabant mhux irrakkomandata f’ pazjenti b’ mard psikjatriku mhux kontrollat.
Rimonabant, ro
Jekk waqt ed
however, should be used with caution in these patients, see also section 5.3.
it- terapija b’ rimonabant jiġi dijanostikat mard psikjatriku, il- kura għanda tieqaf.
• Hepatic impairment lp
• Attakki Epilettiċi tt m
Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic impairment.
Rimonabant ma ġiex studjat f’ dawk il- pazjenti li qed jiġu ikkurati ghall- epilessija.
The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended. ina
Fi provi kliniċi, ma kienx hemm differenza fl- inċidenza ta ’ attakki epilettiċi f’ pazjenti li rċevew rimonabant jew il- plaċebo.
• Renal impairment There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment.
• Indeboliment tal- fwied Rimonabant huwa metaboliżżat mill- fwied, għalhekk, hija irrakkomandata l- kawtela f’ pazjenti Pro
4.2 and 5.2).
b’ indeboliment moderat tal- fwied.
• Elderly The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently Me
• Indeboliment renali Hemm data limitata dwar pazjenti li għandhom indeboliment renali moderat u m’ hemmx data dwar pazjenti b’ indeboliment renali sever.
Rimonabant should be used with caution in this population (see section 5.2).
Rimonabant m’ għandux jintuża f’ pazjenti li għandhom indeboliment renali sever (ara sezzjoni 4. 2 u 5. 2).
3 • Race The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians.
3 • Anzjani L- effikaċja u s- sigurtà bit- trattament b’ rimonabant f’ pazjenti ’ l fuq minn 75 sena ma ġewx stabbiliti biżżejjed.
This could be caused by a higher rimonabant clearance than in Caucasians resulting in a lower exposure
Rimonabant għandu jintuża b’ kawtela f’ dan il- grupp ta ’ pazjenti (ara sezzjoni 5. 2).
ise • Diabetic patients
Dan
Due to the effect of rimonabant on the blood glucose level, when rimonabant is administered in diabetic patients, hypoglyceamia can occur (see section 4.8).
at seta ’ kien dovut għat- tneħħija aktar mgħaġġla ta rimonabant mill- ġisem fis- Suwed komparat mal - Kawkasi, li ikkaġġunat espożizzjoni aktar baxxa (ara sezzjoni 5. 2).
Monitoring of blood glucose level is
izz • Pazjenti dijabetiċi Minħabba l- effett ta ’ rimonabant fuq il- livell ta ’ glucose fid- demm, meta rimonabant jingħata
or recommended in these patients.
tor f’ pazjenti dijabetiċi, tista ’ sseħħ l- ipogliċemija (ara sezzjoni 4. 8).
uth Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e. g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(see section 4.5).
aw • Interazzjoni bejn mediċini Rimonabant għandu jintuża b’ kawtela meta jingħata flimkien ma ’ inibituri qawwija ta ’ CYP3A4 (bhal ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone); ara sezzjoni 4. 5.
ra Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
ux • Lattosju Peress li l- pilloli ta ’ ACOMPLIA għandhom il- lattosju, pazjenti b’ mard rari ereditarju ta ’ intolleranza ad ghall - galattosju, id- defiċjenza tal- lactase tat- tip Lapp jew in- nuqqas ta ’ assorbiment tal- glukosju u l - galattosju, m’ għandhomx jieħdu din il- mediċina. għ Il- pazjenti għandhom ikunu mwissija biex ma jżiedux id- doża ta ’ ACOMPLIA.
ge Patients should be instructed not to increase their dose of ACOMPLIA.
Pazjenti li kellhom xi attakk ta’ mard tal qalb u dak vaskulari (bħal infart tal- qalb u puplesija eċċ), m ’
Patients who had a cardiovascular event (myocardial infarction, stroke, etc.) less than 6 months ago lon were excluded in the studies for rimonabant.
inqas minn 6 xhur qabel, kienu esklużi mill- istudji fuq rimonabant.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu li li
Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in no
In- vitro, rimonabant huwa metaboliżżat mis- sistemi ta ’ CYP3A u l- amidohydrolase a
vitro.
(predominantement dik tal- fwied).
Concomitant administration of CYP3A4 inhibitors will lead to increased exposure of rimonabant.
dan iwassal għal espożizzjoni akbar ta ’ rimonabant.
Concomitant administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant. ct
Meta jingħataw sustanzi li jinduċu s- sistema CYP3A4 konkomitanti ma ’ rimonabant dan mistenni li jnaqqas l- espożizzjoni għal rimonabant.
Potential for other medicinal products to affect rimonabant:
Il- potenzjal ta ’ prodotti mediċinali li jeffetwaw rimonabant: ed
by 104% (95% prediction interval:
It- teħid ta ’ ketoconazole (inibitur qawwi ta ’ CYP3A4), flimkien ma ’ rimonabant, żied l- AUC ta ’ rimonabant b’ 104% (b’ intervall imbassar ta ’ 95%:
A similar increase in exposure is expected with other potent CYP3A4 inhibitors.
Żieda simili fl- espożizzjoni hija mistennija b’ inibituri oħra qawwija ta ’ CYP3A4.
Caution is advised during concomitant use of ACOMPLIA and potent CYP3A4 inhibitors (e. g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone). ro
Il- kawtela hija irrakkomandata fl- użu simultanju ta ’ tt m
Although concomitant administration of CYP3A4 inducers (e. g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John’ s wort) has not been studied, it is expected that concomitant administration of potent CYP3A4 inducers may reduce the plasma concentration of rimonabant and may result in loss of lp
Għalkemm it- teħid ta ’ rimonabant flimkien ma ’ sustanzi li jistimulaw CYP3A4 (bħal rifampicin, phenytoin, phenobarbital, carbamazepine u St John’ s wort) ma ġiex studjat, huwa mistenni li l- użu do
efficacy.
Pro
Concomitant administration of orlistat, ethanol or lorazepam had no significant effect on the plasma ina
L- użu konkomitanti ta ’ orlistat, ethanol jew lorazepam ma ’ rimonabant ma kellux effett sinifikanti fuq il- livelli ta ’ rimonabant fil- plażma.
Potential for rimonabant to affect other medicinal products:
4 Il- potenzjal għal rimonabant li jeffetwa sustanzi mediċinali ohra:
The in vivo inhibitory effect on CYP2C8 has not been studied.
L- effett inibitorju in vivo fuq is- sistema CYP2C8 ma kienx studjat.
mild inhibitory effect on CYP2C8.
Madankollu, ir- rimonabant kellu effett inibitorju ħafif fuq CYP2C8 in vitro.
The potential for inhibition of CYP2C8 in vivo appears to be low.
Il- potenzjal għall- inibizzjoni in vivo fuq CYP2C8 jidher li huwa baxx.
Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro.
Rimonabant ma jinibixxix u anqas jinduċi enżimi CYP jew P- glycoprotein (P- gp) in vitro.
Me
Dan kien ikkonfermat klinikament fi studji xierqa u speċifiċi meta ntużaw midazolam (li CYP3A4 jaħdem fuqu), warfarin (li CYP2C9 jaħdem fuqha) u digoxin (li P- gp jaħdem fuqu).
The steady-state pharmacokinetics of an ethinyl estradiol/ levonorgestrel combination oral contraceptive were not significantly altered by concomitant administration of rimonabant.
at Il- komportament farmakokinetiku ta ’ kontraċettiv orali (magħmul minn ethinyl estradiol/ levonorgestrel) meta jilħaq livelli kostanti fid- demm, ma kienx sinifikantement mibdul meta
4 4.6 Pregnancy and lactation
izz ngħata rimonabant fl- istess ħin.
There are no adequate or well-controlled studies in pregnant women.
tor M’ hemmx studji adegwati jew ikkontrollati sew f’ nisa tqal.
Animal data are inconclusive but
Id- data fl- annimali mhumiex konklussivi iżda jissuġerixxu li jista ’ jkollu possibbilment jagħmel ħsara fuq l- iżvilupp ta ’ l- embriju/ fetu (ara
d suggest possible deleterious effects on embryonal/ foetal development (see section 5.3).
Ir- riskju potenzjali għal bniedem mhux magħruf.
The potential risk for humans is unknown.
L- użu fit- tqala, għalhekk, mhux irrakkomandat.
Patients should notify
Il- pazjenti għandhom jinfurmaw lit- tabib jekk joħorġu tqal waqt il- kura b’ ACOMPLIA.
ise their physician if they become pregnant during treatment with ACOMPLIA.
Rimonabant instab fil- ħalib ta ’ firien li qed ireddgħu u rimonabant jista ’ jinibixxi ir- rifless tad -
Rimonabant has been detected in the milk of lactating rats and rimonabant may inhibit the suckling reflex.
ux treddigħ.
ACOMPLIA is contraindicated during
Mhux magħruf jekk rimonabant jaqsamx fil- ħalib tal- bniedem.
or breast-feeding (see section 4.3).
ACOMPLIA huwa kontra - indikat waqt it- treddigħ (ara sezzjon 4. 3).
uth No studies on the effects on the ability to drive and use machines have been performed.
ad 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni għ Ma sarux studji dwar l- effetti fuq il- ħila biex issuq u tħaddem magni.
Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of any significant cognitive or sedative effect.
Investigazzjonijiet konoxxittivi fi studju tal- farmakoloġija klinika urew li rimonabant m’ għandu ebda effett sinifikanti ta ’ natura konoxxittiva jew sedattiva. m ’
ra 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa li li
ACOMPLIA 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies
Fi studji kliniċi kontrollati bil - a
ge that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3800 patients in other indications.
placebo, il- waqfien ta ’ rimonabant dovut għall- reazzjonijiet avversi kien ta ’ 15. 7% tal- pazjenti.
In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7% for patients receiving rimonabant.
L - aktar effetti avversi komuni li wasslu għall- waqfien fit- trattament kienu: id- dardir, bidla fil- burdata iċin
The most common adverse lon reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive disorders, anxiety and dizziness.
b’ sintomi depressivi, mard depressiv, anzjetà u sturdament.
Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg.
aktar milli suppost u li kellhom fatturi miżjuda ta ’ riskju li kienu ittrattati b’ 20 mg ta ’ rimonabant.
These were usually mild or moderate in severity and no
Dawn l- episodji kienu normalment ħfief jew ta ’ severità moderata u li marru għal kollox, fil- każijiet kollha, wara trattament korrettiv, jew il- waqfien ta ’ rimonabant; dawn ma wrew ebda karatteristici li tt m
resulted in recovery in all cases either after corrective treatment or discontinuation of rimonabant and did not exhibit any differentiating characteristics compared to cases reported in the control groups.
iddistingwewhom meta kienu mqabbla mal- każijiet irrapportati fil- gruppi ta ’ kontroll.
The following table (table 1) shows all treatment-emergent adverse reactions from placebo-controlled ct
It- tabella li tmiss (tabella 1) turi r- reazzjonijiet avversi kollha, dovuti għat- trattament, minn studji ikkontrollati bil- plaċebo, f’ pazjenti ittrattati għal telf fil- piż u mard ħafif metaboliku relatat, meta dawn do
studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events ≥ 1%) or considered clinically relevant (for events < 1%). du
kellhom inċidenza statistikament sinifikanti, akbar mir- rata korrispondenti bil- plaċebo, (għal grajjiet ta ’ ≥ 1%), jew ikkunsidrati klinikament rilevanti (għal grajjiet ta ’ < 1%) Pro
Classification of expected frequencies of undesirable effects:
Klassifikazzjoni tal- frekwenzi mistennija ta ’ l- effetti mhux mixtieqa:
Very common (≥ 10%); Common (≥ 1, < 10%); Uncommon (≥ 0.1, < 1%); Rare (≥ 0.01, < 0.1%); Very ro
Komuni ħafna (≥ 10%); komuni (≥ 1, < 10%); mhux komuni (≥ 0. 1, < 1%); rari (≥ 0. 01, < 0. 1%); rari ħafna (< 0. 01%); u mhux maghruf (ghax ma tistax tkun stmata mid- data disponibbli).
rare (< 0.01%), Not known (cannot be estimated from the available data). lp ina dic Me
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
5 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
L - effetti li huma l- aktar serji għandhom jiniżżlu l- ewwel, segwiti minn dawk anqas serji.
Table 1:
5 Tabella 1
System Organ Class
Sistema tal - Klassifika ta ’ l - Organi
Infections infestations Metabolism and
Infezzjonijiet u infestazzjonijiet
and Upper respiratory Gastroenteritis tract infection
Infezzjonijiet respiratorji tal - parti ta ’ fuq
or nutrition disorders
at Ipogliċemija * Disturbi fil - metaboliżmu u n -
Psychiatric disorders
izz nutrizzjoni Disturbi psikjatriċi
Depressive disorders
Mard depressiv
Panic symptoms Anger
Sintomi ta ’
Hallucinations
Alluċinazzjonijiet
uth Mood alterations Dysphoria
Bidla fil- burdata
with depressive symptoms Anxiety
b’ sintomi depressivi Ansjetà
Emotional disorder Suicidal ideation
Rabja Disforija Mard
ra
aw
Irritability Nervousness Sleep disorders Insomnia
Irritabilità Nervożità Mard li jeffetwa l- irqad
Aggressiveness Aggressive behaviour
emozzjonali Formazzjoni ta’ idejat suwiċidali
ge Parasomnias
Nuqqas ta ’ rqad Parasonja ad
Memory loss Dizziness lon Hypoaesthesia Sciatica Paresthesia
Nuqqas ta ’ memorja għ Sturdament Ipoestesija Xjatika m ’
Lethargy Tremor
Parasteżija
Vascular disorders Respiratory,
Disturbi vaskulari
Hot flush
Fwawar
Hiccups
li li
thoracic and mediastinal disorders
Sulluzzu Disturbi respiratorji, toraċiċi a
Gastrointestinal
u medjastinali iċin
Diarrhoea
Disturbi gastro - intestinali
disorders
Dardir
Vomiting
Dijarrea Rimettar
Skin and
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il -
du
ed
Pruritus
Ħakk Tagħriq eċċessiv
Night sweats
Tagħriq matul il - lejl
subcutaneous tissue disorders
ġilda Disturbi muskolu - skeletrali u tal -
Hyperhidrosis
tt m
Musculoskeletal and ro
Infjammazzjoni ta ’ l- għerq
connective tissue disorders lp
Bugħawwieġ connective tissue Spażmi muskolari Disturbi ġenerali do
Muscle spasms
Astenja/ għejja Influwenza Pro
General disorders
*
Asthenia/ fatigue Influenza
Korriment, avvalenament u komplikazzjonijiet ta ’ xi proċedura
Injury, Poisoning and procedural ina
Waqgħa Kontużjoni Tfekkik ta ’ ġog
Fall Contusion
il- frekwenza hija bbażata biss fuq rapporti f’ pazjenti dijabetiċi li huma obeżi jew li għandhom piż żejjed
complications
6 Fi studji kliniċi għal indikazzjonijiet oħra, reazzjonijiet avversi addizzjonali li ġejjin kienu komunement rapportati:
*frequency is based only on reports in obese or overweight diabetic patients.
- infezzjonijiet u infestazzjonijiet: sinożite
In clinical studies for other indications, the following additional adverse reactions were commonly dic
- mard marbut mal- metaboliżmu u n- nutrizzjoni: anoreksja, nuqqas ta ’ aptit
reported: − infections and infestations: sinusitis − metabolism and nutrition disorders: anorexia, decreased appetite, Me
- mard gastro- intestinali: dwejjaq fl- istonku nixfa tal- ħalq.
− gastrointestinal disorders: stomach discomfort, dry mouth.
Wara li l- prodott tqiegħed fis- suq
6 Post-Marketing In addition the following adverse reactions were reported during postmarketing (frequency not known):
at Wara li l- prodott tqiegħed fis- suq, ġew ukoll irrapportati r- reazzjonijiet avversi li ġejjien (il- frekwenza m’ hijiex magħrufa):
d − Psychiatric disorder: psychotic disorders including hallucinations, delusion and paranoia. − Skin and subcutaneous tissue disorders: rash.
izz – Disturbi psikjatriċi: disturbi psikotiċi li jinkludu alluċinazzjonijiet, taqriq u paranojja. – Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda: raxx. – Disturbi fis- sistema nervuża: konvulżjonijiet, disturbi fl- attenzjoni, uġigħ ta ’ ras.
ise − Nervous disorders: convulsions, disturbance in attention, headache. − gastrointestinal disorders: abdominal pain.
tor – Disturbi gastro- intestinali: uġigħ addominali
Laboratory adverse events
Grajjiet avversi fit- testijiet tal- laboratorju
or ACOMPLIA has not been shown to alter laboratory test values.
aw ACOMPLIA ma ntweriex li effetwa ir- riżultati tat- testiijiet tal- laboratorju.
uth Experience with rimonabant in overdosage is limited.
ux L- esperjenza b’ rimonabant b’ dożaġġi eċċessivi hija limitata.
In a single-dose tolerability study, doses up to 300 mg were administered to a limited number of subjects with only minor symptoms reported.
Fi studju ibbażat fuq it- tollerabbilità ta ’ doża waħda, fejn ingħataw dożi sa 300 mg lil numru żgħir ta ’ suġġetti, sintomi minuri biss kienu rapportati.
These included headache, euphoria, fatigue and insomnia.
Dawn inkludew uġigħ ta ’ ras, ewforija, għejja u nuqqas ta’ rqad.
ra plateau in exposures is reached at 180 mg.
Il- komportament ad farmakokinetiku juri li meta tintlaħaq doża ta ’ 180 mg ma jkunx hemm caqlieq fuq l- effetti fid- daqs ta ’ l- espożizzjoni.
There is no specific antidote for rimonabant; therefore, appropriate supportive measures should be initiated in case of overdose.
M’ hemmx antidot specifiku għal rimonabant; għalhekk, miżuri xierqa ta ’ support għ għandhom jinbdew f’ każ ta ’ doża eċċessiva.
ge unobstructed, monitoring cardiovascular function and general symptomatic and supportive measures.
It- trattament jikkonsisti f’ miżuri generali li wieħed soltu jieħu f’ każijiet ta ’ dożaġġi eċċessivi, bħal ngħidu aħna iż- żamm bla xkiel tal- ventilazzjoni tal- pulmuni, l- immoniterjar tal- funzjoni tal- qalb u ċ- ċirkolazzjoni, u miżuri ġenerali sintomatiċi u ta ’ support. m ’
PHARMACOLOGICAL PROPERTIES lon 5.1 Pharmacodynamic properties
5. 1 Tagħrif farmakodinamiku a
Anti obesity agent ATC code:
Mediċina għall- kura tal- obeżità Kodiċi ATC:
A08AX01 no
A08AX01 iċin
The endocannabinoid system is a physiological system present in brain and peripheral tissues ct
Rimonabant huwa antagonist selettiv għar- reċettur cannabinoid – 1 (CB1), li jinibixxi l- effetti farmakoloġiċi ta ’ l- agonisti cannabinoid, kemm in vitro kif ukoll in vivo. ed
(including adipocytes) that affects energy balance, glucose and lipid metabolism and body weight, and in neurons of the mesolimbic system modulates the intake of highly palatable, sweet or fatty foods. du
Is- sistema endocannabinoid hija sistema fiżjoloġika li tinsab fil- moħħ u t- tessuti periferali (li jinkludu iċ- ċelluli li jaħżnu x- xaħam), li teffettwa l- bilanċ fl- enerġija, il- metaboliżmu tal- glukosju u x- xaħam u l- piż tal- ġisem, u fin- newroni tas- sistema mesolimbic tikkontrolla t- teħid ta ’ l- ikel ħelu jew xaħmi li tt m
Clinical study results
għandu togħma tajba ħafna.
Weight Management ro
L- Immaniġġar tal- Piż
In total more than 6800 patients were included in the Phase 2 and Phase 3 clinical studies.
Il- pazjenti Pro
The patients included in the phase 3 trials followed a restrictive diet during the trial prescribed by a dietician and lp
imdaħħla fil- fażi 3 tal- provi segwew dieta restrittiva waqt il- prova, preskritta minn espert tad- dieta, u kienu ngħataw parir biex iżidu l- eżerċizzju fiżiku.
Patients had a BMI ≥ 30 kg/ m² or BMI > 27 kg/ m² with hypertension and/ or dyslipidemia at inclusion.
Il- pazjenti fil- bidu kellhom BMI ta ’ ≥ 30 kg/ m2 jew BMI > 27 kg/ m2, akkompanjat ma ’ pressjoni għolja tad- demm u/ jew abnormalitajiet fil- livelli tax - xaħmijiet fid- demm.
Approximately 80% of the population were women, 87% Caucasian and 9% Black.
Approssimattivament, 80% tal- grupp kienu nisa, 87% Kawkasi u 9% Suwed.
Experience in patients over 75 years and ina
L - esperjenza hija limitata f’ pazjenti ’ l fuq minn 75 sena u f’ nies Orjentali/ Asjatiċi.
A mean weight loss of 6.5 kg dic
7 It- tnaqqis medju u sinifikanti fil- piż mil- linja bażi sa sena, ta ’ 20 mg ACOMPLIA, meta mqabbel mal - plaċebo, intwera fi tliet studji magħmulin fuq pazjenti mhux dijabetiċi.
from baseline to one year was shown for ACOMPLIA 20 mg versus a mean weight loss of 1.6 kg for placebo (Difference -4.9 kg CI95% -5.3; -4.4, p < 0.001).
Intwera telf medju ta ’ 6. 5 kg fil- piż mil- linja bażi sa sena għal 20 mg ta ’ ACOMPLIA, kontra t- telf medju ta ’ 1. 6 kg għall- plaċebo (Differenza - 4. 9 kg CI95% - 5. 3; - 4. 4, p < 0. 001).
Me
Il- persentaġġi ta ’ pazjenti li tilfu 5% u 10% tal- linja bażi fil- piż tal- ġisem, wara sena trattament, qed jingħataw f’ tabella 2:
7 Table 2:
at Tabella 2
Non-diabetic studies
Studji mhux fuq dijabetiċi
Placebo ACOMPLIA
Studji fuq dijabetiċi
Placebo
izz
ACOMPLIA
Plaċebo
Weight at baseline (kg)
tor Piż fil- linja bażi (kg)
Subjects with a 5%
aw Suġġetti b’ tnaqqis fil - piż ta ’ 5%
19.7%
19. 7%
50.8%
50. 8%
14.5%
14. 5%
49.4%
49. 4%
Difference (CI 95%)
Differenza (CI 95%)
31.1% (28%; 34%)
31. 1% (28%; 34%)
34.9% (28%; 41%)
34. 9% (28%; 41%)
uth
16. 2%
Subjects with a 10% 7.8% weight reduction
Differenza (CI 95%)
27.0%
19. 2% (17%; 22%)
2.0%
għ
14.2% (10%; 19%)
14. 2% (10%; 19%)
ra Most of the observed weight reduction was obtained within the first nine months of treatment.
L- aktar tnaqqis fil- piż li intwera kien fl- ewwel disa ’ xhur ta ’ trattament.
ACOMPLIA 20 mg was effective in maintaining weight loss up to two years.
ACOMPLIA 20 mg kien effettiv billi żamm it- tnaqqis fil- piż sa sentejn.
Weight loss at two years
It- tnaqqis fil- piż ma tmiem is- sentejn kien ta ’ 5. 1 kg m ’
ge was 5.1 kg for patients who received ACOMPLIA 20 mg and 1.2 kg for placebo (Difference -3.8 kg; CI95% -4.4, -3.3; p < 0.001).
għall- pazjenti li ħadu 20 mg ACOMPLIA, u 1. 2 kg għall- plaċebo (Differenza - 3. 8 kg; CI95% - 4. 4, - 3. 3; p < 0. 001). li li
Rimonabant 20 mg reduced the risk of weight regain.
Għoxrin (20) mg ta ’ rimonabant naqqas ir- riskju li l- piż mitluf jerġa jiġi akkwistat.
Patients who received ACOMPLIA 20 mg for one year were re-randomized to ACOMPLIA 20 mg or placebo.
Il- pazjenti li irċevew 20 mg ta ’ ACOMPLIA għal sena reġgħu tqassmu, b’ mod ‘ randomised ’, fi grupp fuq 20 mg ACOMPLIA, u ieħor fuq il- plaċebo.
At two years, patients continuing on rimonabant had a mean total weight loss of 7.5 kg over 2 years whereas patients re-randomized to placebo group during the second year had a mean total weight loss of 3.1 kg over 2 years.
Mas- sentejn, il- pazjenti li komplew jieħdu rimonabant kellhom a
At two years, the difference in total weight loss between ACOMPLIA and placebo was -4.2 kg (CI95% -5.0; - no
telf fil- piż totali medju ta ’ 7. 5 kg fuq sentejn, fil- waqt il- pazjenti li tqassmu fil- grupp tal- plaċebo fit - iċin
3.4, p < 0.001).
Fl- ahhar tas- sentejn id - differenza fil- piż totali bejn ACOMPLIA u l- plaċebo kienet ta ’ - 4. 2 kg (CI95% - 5. 0; - 3. 4, p < 0. 001).
Treatment with rimonabant was associated with significant reductions in waist circumference, a known marker of intra-abdominal fat. ct
It- trattament bi rimonabant kien assoċjat ma ’ tnaqqis sinifikanti fiċ- ċirkonferenza tal- qadd, indikatur ed
The effects on body weight appeared to be consistent among men and women.
magħruf ta ’ l- ammont ta ’ xaħam ġewwa l- kavità taż- żaqq.
In the limited number of Black patients weight loss was less pronounced (mean difference to placebo -2.9 kg).
L- effetti fuq il- piż tal- ġisem dehru li kienu konsistenti fost l- irġiel u n- nisa.
No du
F’ numru limitat ta ’ tt m
conclusions can be drawn with regard to effects in patients over 75 years or in Asian/ Oriental patients due to the low number of patients. ro
Wieħed ma jistax jasal għal konklużjonijiet rigward l- effetti f’ pazjenti ’ l fuq minn 75 sena, jew dawk Asjatiċi/ Orjentali, dovut għan- numru żgħir ta ’ pazjenti. do Pro
For lp
8 L- immaniġġar tal- piż u fatturi ta ’ riskji żejda Fi studji magħmulin fuq suġġetti mhux dijabetiċi, li inkludew grupp imħallat ta ’ suġġetti b’ abnormalitajiet fil- livelli tax- xaħmijiet fid- demm u dawk mingħajr dawn l- abnormalitajiet (ittrattati), kienet irreġistrata (f’ sena), żieda f’ HDL- C u tnaqqis fit- triglycerides.
HDL-C an average increase of 16.4% was seen under rimonabant 20 mg (baseline HDL-C 1.24 mmol/ l) compared to an increase of 8.9% for placebo (baseline HDL-C 1.21 mmol/ l).
Fil- każ ta ’ HDL- C żieda medja ta ’ 16. 4% intweriet b’ 20 mg ta ’ rimonabant (linja bażi HDL- C 1. 24 mmol/ l), meta mqabbla ma ’ żieda ta ’ 8. 9% bil- plaċebo (linja bażi HDL- C 1. 21 mmol/ l).
For the ina
Id- differenza kienet statistikament sinifikanti
The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p < 0.001).
at (Differenza 7. 9% CI95% 6. 6%; 9. 2%, p < 0. 001).
It is estimated that approximately half of the observed improvement in HDL-C and triglycerides in patients who received dic
Fil- każ tat- triglycerides tnaqqis medju ta ’ 6. 9% intwera b’ 20 mg ta ’ rimonabant (linja bażi TG 1. 62 mmol/ l), meta mqabbel ma ’ żieda ta ’ 5. 8% bil- plaċebo
rimonabant 20 mg was beyond that expected from weight loss alone.
Huwa stmat li madwar nofs it- titjib irreġistrat f’ HDL- C u t- triglycerides, f’ pazjenti li rċevew 20 mg ta ’ rimonabant, kien ’ l hinn minn dak mistenni bit- tnaqqis fil- piż biss.
Generally ACOMPLIA 20 mg had no significant effect on Total-C or LDL-C levels.
tor Bhala regola 20 mg ta ’ ACOMPLIA ma kellux effett fuq il- livelli totali ta ’ C jew ta ’ LDL- C.
In the trial in type 2 diabetic patients (RIO-Diabetes) who were overweight or obese treated with Me
Fl- istudji investigattivi dwar il- pazjenti li kellhom id- dijabete tip 2 (RIO- Diabetes), u li kienu jiżnu
metformin or sulfonylurea improvements in HbA1c and body weight were observed.
aw aktar minn normal, jew kienu qed ibatu mill- obeżità, it- trattament bil- metformin jew bis- sulfonylurea ġew innotati titjib fil- HbA1c u fil- piż tal- ġisem.
The absolute change in HbA1c at one year was -0.6 for rimonabant 20 mg (baseline 7.3%) and +0.1 on placebo (baseline 7.2%).
Il- bidla assoluta fil- livelli ta ’ HbA1c mat- tmiem l - ewwel sena kien ta ’ - 0. 6 b’ 20 mg rimonabant (linja bażi 7. 3%) u +0. 1% bil- plaċebo (linja bażi 7. 2%).
Differences were statistically significant (Difference -0.7%, CI95% -0.80; -0.5, p < 0.001).
Id- differenzi kienu statistikament sinifikanti (Differenza ta ’ - 0. 7%, CI95% - 0. 80; - 0. 5, p < 0. 001).
8 At one year a mean weight loss of 5.3 kg was shown for ACOMPLIA 20 mg versus a loss on placebo of 1.4 kg (Difference – 3.9 kg CI95% -4.6; -3.3 p < 0.001).
ux Wara sena, intwera tnaqqis medju fil- piż ta ’ 5. 3 kg b’ ACOMPLIA 20 mg meta mqabbel mat- tnaqqis ta ’ 1. 4 kg bil- plaċebo (Differenza – 3. 9 kg CI95% - 4. 6; - 3. 3 p < 0. 001).
The percentage of patients who lost 5% and 10% of their baseline body weight after 1 year of treatment are given in the table 2.
Il- persentaġġi ta ’ pazjenti li tilfu 5% u 10% tal- linja bażi fil- piż tal- ġisem, wara sena trattament, qed jingħataw f’ tabella 2. ad F’ studju investigattiv ieħor (Serenade) f’ pazjenti naïve li kellhom id- dijabete tip 2 u li kienu qed ibatu mill- obeżità, il- bidla assoluta fil- livelli ta ’ HBA1c (b’ linja bażi ta ’ 7. 9% għaz- zewġ gruppi) wara sitt għ xhur kien - 0. 8 b’ rimonabant 20 mg u - 0. 3 bil- plaċebo (Differenza - 0. 51 CI95% - 0. 78, - 0. 24 p < 0. 001).
d In a second trial in treatment naïve type 2 diabetic obese patients (Serenade), the absolute change in HbA1c (with a baseline of 7.9% for both groups) at six months was -0.8 for rimonabant 20 mg and
Id- differenza medja ta ’ bidla fil- piz tal- ġisem bejn il- gruppi ta ’ 20mg u l - m ’
ise -0.3 under placebo (Difference -0.51 CI95% -0.78, -0.24 p < 0.001).
plaċebo kien ta ’ 3. 8 kg (CI95% - 5. 0, - 2. 6 p < 0. 001).
The percentage of patients reaching HbA1c < 7% was 51% in the rimonabant group and 35% in the placebo group.
Il- bidliet f’ HDL- C u t- TG f’ dan il- grupp ta ’ suġġetti kienu simili għal dawk li ma kienux dijabetiċi.
The difference in mean body weight change between the 20 mg and placebo groups was 3.8 kg (CI95% -5.0, -2.6 p < 0.001).
Huwa stmat li madwar nofs tat- titjib medju fil- HbA1c f’ pazjenti li rċevew 20 mg ta’ rimonabant kien ’ l li li
or estimated that approximately half of the mean improvement in HbA1c in patients receiving rimonabant 20 mg was beyond that expected from weight loss alone.
hinn minn dak mistenni bit- tnaqqis fil- piż biss.
uth 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku a
Rimonabant pharmacokinetics are fairly dose proportional up to about 20 mg.
Il- komportament farmakokinetiku hu pjuttost proporzjonali sa madwar 20 mg.
AUC increased less than in proportion to dose above 20 mg.
bħala proporzjon tad- doża meta din kienet ’ l fuq minn 20 mg.
ra Absorption:
Assorbiment: ed
Rimonabant displays high in vitro permeability and is not a substrate of P-glycoprotein.
Rimonabant juri permeabilità għolja in vitro u mhux sustrat tal- P- glycoprotein.
The absolute bioavailability of rimonabant has not been determined.
Id- disponibbiltà bijoloġika assoluta ta ’ rimonabant ma kienetx maħduma.
Following multiple once-daily doses of 20 mg
Wara li ngħataw dożi repetuti ta ’ 20 mg darba kuljum lil suġġetti sajmin u b’ saħħithom, il- livelli massimi ta ’ rimonabant fil- plażma intleħqu tt m
ge to healthy subjects in the fasted state, maximum plasma concentrations of rimonabant are achieved in approximately 2 hours with steady state plasma levels achieved within 13 days (Cmax = 196 ± 28.1 ng/ ml; Ctrough = 91.6 ± 14.1 ng/ ml; AUC0-24 = 2960 ± 268 ng. h/ ml).
f’ madwar sagħtejn, b’ livelli stabbli fil- plażma irreġistrati fi żmien 13- il jum (Cmax = 196 ± 28. 1 ng/ ml; Ctrough = 91. 6 ± 14. 1 ng/ ml; AUC0- 24 = 2960 ± 268 ng. siegħa/ ml).
Steady state rimonabant lon exposures are 3.3-fold higher than those observed after the first dose.
L- espożizzjonijiet ta ’ rimonabant fl - istat stabbli huma ta ’ 3. 3- il darba minn dawk innotati wara l- ewwel doża.