FrancophonIA/ELRC3.0 huggingface dataset:
English: ADENURIC tablets contain the active substance febuxostat and are used to treat gout, which is associated with an excess of a chemical called uric acid (urate) in the body.
Maltese: Pilloli ADENURIC fihom is-sustanza attiva febuxostat u jintuzaw għall-kura tal-gotta, li hija assoċjata ma' kimika żejda msejħa uric acid (urate) fil-ġisem.
English: ADENURIC 120 mg film-coated tablets Febuxostat
Maltese: ADENURIC 120 mg pilloli miksija b'rita Febuxostat
English: Table 2 Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 µmol/L) Last Three Monthly Visits
Maltese: Tnaqqis fil-livell ta' uric acid fis-serum għal <6.0 mg/dL (357 µmol/L) kien innutat maż-żjara ta'
English: During the CONFIRMS study, the percentages of patients who required treatment for gout flares (Day 1 through Month 6) were 31% and 25% for the febuxostat 80 mg and allopurinol groups, respectively.
Maltese: (Jum 1 sa Xahar 6) kienu 31% u 25% tal-gruppi fuq febuxostat 80 mg u allopurinol, rispettivament.
English: • potentially life-threatening skin rashes characterised by formation of blisters and shedding of the skin and inner surfaces of body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (Stevens- Johnson Syndrome/ Toxic Epidermal Necrolysis), or by enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (drug reaction with eosinophilia and systemic symptoms-DRESS) (see section 2)
Maltese: • raxxijiet li jistgħu jkunu ta' theddida għall-ħajja li għandhom karatteristika li jiffurmaw ponot u titqaxxar il-ġilda u s-superfiċji interni tad-daħliet fil-ġisem, eż ħalq u ġenitali, ulċeri bl-uġigħ filħalq u/jew partijiet ġenitali, flimkien ma' deni, grieżem misluħin u għeja (Sindrome ta' Stevens Johnsons/Nekrolisi Epidermali Tossika), jew b'għenieqed limfatiċi minfuħa, fwied minfuħ,
English: Blood amylase increase, platelet count decrease, WBC decrease, lymphocyte count decrease, blood creatine increase, blood creatinine increase, haemoglobin decrease, blood urea increase, blood triglycerides increase, blood cholesterol increase, haematocritic decrease, blood lactate dehydrogenase increased, blood potassium increase
Maltese: Żjieda ta' amylase fid-demm, tnaqqis fl-għadd ta' plejtlits, tnaqqis fl-għadd tal-WBC, tnaqqis fl-għadd tal-limfoċiti, żjieda tal krejatinina fid-demm, tnaqqis fl-emoglobina, żjieda tal-urea fiddemm, żjieda tat-trigliserajds fid-demm, żjieda tal-kolesterol fiddemm, tnaqqis tal-ħematokrit, żjieda tal-lactate dehydrogenase fid-demm, jiżdied il-potassium fid-demm Rari
English: The therapeutic target is to decrease and maintain serum uric acid below 6 mg/dL (357 μmol/L).
Maltese: 300 mg, biex inaqqsu u jżommu l-sUA taħt 6 mg/dL (357 µmol/L).
English: Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “80” on one side and a score line on the other side.
Maltese: Pilloli forma ta' kapsula, sofor ċari sa sofor, miksija b'rita, imnaqqxa b'“80” fuq naħa waħda u sinjal min-naħa għall-oħra tal-pillola fuq in-naħa l-oħra.
English: After the 8-week prophylaxis period, the incidences of flares increased and gradually decreased over time (64% and 70% of subjects received treatment for gout flares from Week 8-52).
Maltese: Wara perijodu ta' profilassi ta' 8 ġimgħat, il-frekwenzi tal-aggravar żdiedu u biż-żmien naqsu bil-mod (64% u 70% tal-individwi irċevew kura għall-aggravar tal-gotta minn Ġimgħa 8-52).
English: The rates of the other MACE events were similar in the febuxostat and allopurinol groups, i.e. non-fatal MI (3.6% vs. 3.8% of patients; HR 0.93; 95% CI 0.72-1.21), non-fatal stroke (2.3% vs. 2.3% of patients; HR 1.01; 95% CI 0.73-1.41) and urgent revascularization due to unstable angina (1.6% vs. 1.8% of patients; HR 0.86; 95% CI 0.59-1.26).
Maltese: 2.3% tal-pazjenti; HR 1.01; 95% CI 0.73-1.41) u rivaskularizzazzjoni urġenti minħabba anġina mhux stabbli (1.6% vs. 1.8%
English: Modelling and simulation analysis of data from a pre-clinical study in rats indicates that, in case of concomitant administration with febuxostat, the dose of mercaptopurine/azathioprine should be reduced to the 20% or less of the previously prescribed dose (see section 4.4 and 5.3).
Maltese: Analiżi ta' mmudellar u simulazzjoni tad-dejta minn studju ta' qabel l-użu kliniku fil-firien tindika li, f'każ ta' għoti flimkien ma' febuxostat, id-doża ta' mercaptopurine/azathioprine għandha titnaqqas għall-20% jew anqas tad-doża li kienet ġiet ordnata qabel (ara sezzjoni 4.4 u 5.3).
English: The 120 mg film-coated tablets are marked on one side with ‘120'.
Maltese: Il-pilloli miksija b'rita ta' 120 mg huma mmarkati fuq naħa waħda b'‘120'.
English: FACT (52 weeks)
Maltese: (52 ġimgħa)
English: How to store ADENURIC
Maltese: X'fih ADENURIC:
English: Potent inducers of UGT enzymes might possibly lead to increased metabolism and decreased efficacy of febuxostat.
Maltese: Hemm possibiltà li ndutturi qawwija tal-enzimi UGT iwasslu għal żjieda fil-metaboliżmu u tnaqqis fleffikaċja ta' febuxostat.
English: FOCUS Study (TMX-01-005) was a 5 years Phase 2, open-label, multicenter, safety extension study for patients who had completed the febuxostat 4 weeks of double blind dosing in study TMX-00-004.
Maltese: L-istudju FOCUS (TMX-01-005) kien studju ta' 5 snin ta' Fażi 2, open-label, multiċentriku, ta' estenzjoni dwar is-sigurtà għall-pazjenti li kienu temmew l-istudju TMX-00-004 ta' 4 ġimgħat b'febuxostat b'dużaġġ double blind. 116 pazjent kienu ngaġġati u rċievew febuxostat 80 mg QD filbidu. 62% tal-pazjenti ma kellhomx bżonn tibdil fid-doża biex iżommu sUA <6 mg/dL u 38% talpazjenti kellhom bżonn tibdil fid-doża biex jiksbu doża stabbli finali.
English: An analysis in patients with gout and renal impairment was prospectively defined in the CONFIRMS study, and showed that febuxostat was significantly more efficacious in lowering serum urate levels to < 6 mg/dL compared to allopurinol 300 mg/200 mg in patients who had gout with mild to moderate renal impairment (65% of patients studied).
Maltese: CONFIRMS, u wera li febuxostat kien aktar effikaċji b'mod sinifikanti biex ibaxxi l-livelli ta' urate fis-serum għal < 6 mg/dL meta mqabbel ma' allopurinol 300 mg/200 mg f'pazjenti li kellhom gotta b'indeboliment renali ħafif għal moderat (65% tal-pazjenti studjati).
English: Organ transplant recipients
Maltese: TAL-PRODOTT MEDIĊINALI
English: Difference (CI 95%)
Maltese: Differenza (CI 95%)
English: (See section 4.3 and 4.8).
Maltese: (Ara sezzjoni 4.3 u 4.8).
English: INFORMATION IN BRAILLE ACOMPLIA
Maltese: INFORMAZZJONI BIL-BRAILLE ACOMPLIA
English: Tablet polishing: carnauba wax (E903)
Maltese: Il-lostru tal-pillola: carnauba wax (E903)
English: • Depressive disorders
Maltese: • Disturbi depressivi
English: The active substance is rimonabant.
Maltese: Is-sustanza attiva hi rimonabant.
English: EXPIRY DATE EXP {MM/YYYY}
Maltese: DATA TA' META JISKADI EXP {XX/SSSS}
English: Panic symptoms Anger
Maltese: Sintomi ta' paniku
English: France sanofi-aventis S.p.A. Strada Statale 17, Km 22 67019 Scoppito (AQ) Italy
Maltese: Strada Statale 17, Km 22 67019 Scoppito (AQ) L-Italja
English: • Lactose
Maltese: • Lattosju
English: Classification of expected frequencies of undesirable effects:
Maltese: Klassifikazzjoni tal-frekwenzi mistennija ta' l-effetti mhux mixtieqa:
English: EU/1/06/344/001 EU/1/06/344/002 EU/1/06/344/003 EU/1/06/344/004 EU/1/06/344/005 EU/1/06/344/006 EU/1/06/344/010 EU/1/06/344/011
Maltese: EU/1/06/344/001 EU/1/06/344/002 EU/1/06/344/003 EU/1/06/344/004
English: Approximately 80% of the population were women, 87% Caucasian and 9% Black.
Maltese: Approssimattivament, 80% tal-grupp kienu nisa, 87% Kawkasi u 9% Suwed.
English: The potential risk for humans is unknown.
Maltese: Ir-riskju potenzjali għal bniedem mhux magħruf.
English: − gastrointestinal disorders: abdominal pain.
Maltese: - Disturbi gastro-intestinali: uġigħ addominali
English: LIST OF EXCIPIENTS Also contains lactose monohydrate.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fihom ukoll il-lactose monohydrate.
English: Very common (≥10%); Common (≥1, <10%); Uncommon (≥0.1, <1%); Rare (≥0.01, <0.1%); Very rare (<0.01%), Not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 10%); komuni (≥ 1, < 10%); mhux komuni (≥ 0.1, < 1%); rari (≥ 0.01, < 0.1%); rari ħafna (< 0.
English: Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
Maltese: Ir-rita tal-pillola: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
English: • Race
Maltese: • Razza
English: Biotransformation:
Maltese: Trasformazzjoni bijoloġika:
English: sanofi-aventis 174 avenue de France F-75013 Paris France
Maltese: sanofi-aventis 174 avenue de France F-75013 Paris Franza
English: The difference was statistically significant (Difference -13.3% CI95% -16.5; -10.2% p< 0.001).
Maltese: Id-differenza kienet statistikament sinifikanti (Differenza -13.3% CI95%16.5; -10.2% p<0.001).
English: Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate
Maltese: Il-qalba tal-pillola: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate
English: The difference was statistically significant (Difference 7.9% CI95% 6.6%; 9.2%, p< 0.001).
Maltese: Id-differenza kienet statistikament sinifikanti (Differenza 7.9% CI95% 6.6%; 9.2%, p<0.001).
English: − Psychiatric disorder: psychotic disorders including hallucinations, delusion and paranoia.
Maltese: - Disturbi psikjatriċi: disturbi psikotiċi li jinkludu alluċinazzjonijiet, taqriq u paranojja.
English: Name and address of the manufacturers responsible for batch release Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, France sanofi-aventis S.p.A., Strada Statale 17, Km 22 , 67019 Scoppito (AQ), Italy The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Maltese: Isem u indirizz tal-manifatturi responsabbli għall-ħruġ tal-lott Sanofi Winthrop Industrie, 30-36 avenue Gustave Eiffel, BP 27166, F-37071 Tours Cedex 2, Franza sanofi-aventis S.p.A., Strada Statale 17, Km 22 , 67019 Scoppito (AQ), L-Italja Fuq il-fuljett ta' tagħrif tal-prodott medicinali għandu jkun hemm l-isem u l-indirizz tal-manifattur responsabbli għall-ħrug tal-lott konċernat.
English: Differences were statistically significant (Difference -0.7%, CI95% -0.80;-0.5, p<0.001).
Maltese: Id-differenzi kienu statistikament sinifikanti (Differenza ta' -0.7%, CI95% -0.80; -0.5, p<0.001).
English: Suicidal ideation Aggressiveness Aggressive behaviour
Maltese: Disforija Mard emozzjonali Formazzjoni ta'idejat suwiċidali Aggresività Mġiba aggresiva
English: Patients with renal impairment:
Maltese: Pazjenti b'indeboliment renali:
English: Tablet core: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate Tablet coating: lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
Maltese: Il-qalba tal-pillola: maize starch, lactose monohydrate, povidone K 30 (E1201), croscarmellose sodium (E468), sodium laurilsulfate (E487), microcrystalline cellulose (E460), magnesium stearate Ir-rita tal-pillola:lactose monohydrate, hypromellose 15 mPa.s (E464), titanium dioxide (E171), macrogol 3000
English: Rimonabant is a selective cannabinoid-1 receptor (CB1) antagonist that inhibits the pharmacological effects of cannabinoid agonists in vitro and in vivo.
Maltese: 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.
English: Table 1: System Organ Class
Maltese: Sistema talKlassifika ta' lOrgani
English: Laboratory adverse events ACOMPLIA has not been shown to alter laboratory test values.
Maltese: Grajjiet avversi fit-testijiet tal-laboratorju ACOMPLIA ma ntweriex li effetwa ir-riżultati tat-testiijiet tal-laboratorju.
English: Concomitant administration of ketoconazole (a potent CYP3A4 inhibitor) increased rimonabant AUC by 104% (95% prediction interval: 40% - 197%).
Maltese: It-teħid ta' ketoconazole (inibitur qawwi ta' CYP3A4), flimkien ma' rimonabant, żied l-AUC ta' rimonabant b'104% (b'intervall imbassar ta' 95%: 40% - 197%).
English: − Nervous disorders: convulsions, disturbance in attention, headache.
Maltese: - Disturbi fis-sistema nervuża: konvulżjonijiet, disturbi fl-attenzjoni, uġigħ ta' ras.
English: Rimonabant displays high in vitro permeability and is not a substrate of P-glycoprotein.
Maltese: Rimonabant juri permeabilità għolja in vitro u mhux sustrat tal-P-glycoprotein.
English: The active ingredient of ACOMPLIA is rimonabant.
Maltese: Is-sustanza attiva ta' ACOMPLIA huwa rimonabant.
English: The tablets contain approx. 115 mg lactose.
Maltese: Il-pilloli fihom madwar 115 mg tal-lattosju.
English: Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro.
Maltese: Rimonabant ma jinibixxix u anqas jinduċi enżimi CYP jew P-glycoprotein (P-gp) in vitro.
English: Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in vitro.
Maltese: In-vitro, rimonabant huwa metaboliżżat mis-sistemi ta' CYP3A u l-amidohydrolase (predominantement dik tal-fwied).
English: ACOMPLIA is contraindicated during breast-feeding (see section 4.3).
Maltese: ACOMPLIA huwa kontraindikat waqt it-treddigħ (ara sezzjon 4.3).
English: Obesity is a condition that can be associated with depressive disorders.
Maltese: L-obesità hija kundizzjoni li tistà tkun assoċjata ma' disturbi depressivi.
English: Convulsion, disturbance in attention, delusion (false belief), paranoia, rash, headache and stomach pain.
Maltese: Konvulżjonijiet, disturbi fl-attenzjoni, taqriq (konvinzjoni qarrieqa) paranojja, raxx, uġigħ ta' ras u uġigħ fl-istonku.
English: Upper respiratory tract infection
Maltese: Infezzjonijiet respiratorji tal
English: Potential for other medicinal products to affect rimonabant:
Maltese: Il-potenzjal ta' prodotti mediċinali li jeffetwaw rimonabant:
English: ACOMPLIA is available in blister packs of 14, 28, 30, 56, 84, 90 and 98 tablets, in perforated unit dose blister packs containing 70 x 1 tablets, and in white plastic bottles containing 28, 98 and 500 tablets.
Maltese: ACOMPLIA huwa disponibbli f'folja ta' 14, 28, 30, 56, 84, 90 u 98 pilloli, f'folji imtaqqbin doża waħda, doża waħda li fihom 70 x 1 pillola, u fi fliexken bojod tal-plastik li fihom 28, 98 u 500 pillola.
English: Asthenia/fatigue Influenza
Maltese: Astenja/għejja Influwenza
English: Lethargy Tremor
Maltese: Dijarrea Rimettar
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini (EMEA): http://www.emea.europa.eu.
English: The percentage of patients reaching HbA1c < 7% was 51% in the rimonabant group and 35% in the placebo group.
Maltese: Il-persentaġġ ta' pazjenti li laħqu il-livell ta' HBA1c <7% kien ta' 51% għall grupp ta' rimonabant u 35% għall grupp tal-plaċebo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 19 June 2006
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI 19 Ġunju 2006
English: 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).
Maltese: 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).
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 70x1 film coated-tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 56 pillola miksija b'rita 70x1 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita
English: There are no data in severe renal impairment.
Maltese: M'hemmx data dwar l-indeboliment renali sever .
English: This was confirmed clinically with specific probe studies using midazolam (CYP 3A4 substrate) and warfarin (CYP 2C9 substrate) and digoxin (a P-gp substrate).
Maltese: 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).
English: There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment.
Maltese: Hemm data limitata dwar pazjenti li għandhom indeboliment renali moderat u m'hemmx data dwar pazjenti b'indeboliment renali sever.
English: In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7% for patients receiving rimonabant.
Maltese: Fi studji kliniċi kontrollati bilplacebo, il-waqfien ta' rimonabant dovut għall-reazzjonijiet avversi kien ta' 15.7% tal-pazjenti.
English: Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.
Maltese: Pazjenti Suwed jistgħu jkollhom sa 31% anqas f'Cmax u 43% anqas flAUC, meta mqabbla ma pazjenti ta' razez oħra.
English: The most common adverse reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive disorders, anxiety and dizziness.
Maltese: Laktar effetti avversi komuni li wasslu għall-waqfien fit-trattament kienu: id-dardir, bidla fil-burdata b'sintomi depressivi, mard depressiv, anzjetà u sturdament.
English: HOW TO TAKE ACOMPLIA
Maltese: QABEL MA TIEĦU ACOMPLIA
English: As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% and Ctrough is expected to increase by 5%.
Maltese: Meta l-piż jiżdied minn 65 għal 200 kg, Cmax huwa mistenni li jonqos b'24% u Ctrough jiżdied b'5%.
English: The in vitro human plasma protein binding of rimonabant is high (> 99.9%) and non-saturable over a wide concentration range.
Maltese: Ir-rabta ta' rimonabant mal-proteini tal-plażma fil-bniedem in vitro huwa għoli (> 99.9%) u ma jistax ikun issaturat fuq medda wiesa' ta' konċentrazzjoni.
English: Sleepiness (lethargy), tremor, night sweats, panic symptoms, hiccups, anger, restlessness (dysphoria), emotional disorder, suicidal thoughts, aggressiveness or aggressive behaviour, hypoglycaemia (low blood sugar).
Maltese: Telqa (letarġija), tregħid, tagħriq bil-lejl, sintomi ta' paniku, sulluzzu, rabja, nuqqas ta' kwiet (disforija), mard ħafif emozzjonali, ħsibijiet dwar suwiċidju, aggressività jew mġiba aggressiva, ipogliċemija (zokkor baxx fid-demm).
English: Each tablet contains 20 mg rimonabant.
Maltese: Kull pillola fiha 20 mg ta' rimonabant.
English: Nausea
Maltese: SUQ
English: • Drug Interaction
Maltese: • Interazzjoni bejn mediċini
English: Do not use ACOMPLIA after the expiry date which is stated on the outer packaging after EXP.
Maltese: Tużax ACOMPLIA wara d-data ta' skadenza li tidher fuq il-kartuna wara EXP.
English: What ACOMPLIA looks like and contents of the pack ACOMPLIA 20 mg is supplied as teardrop-shaped, white film-coated tablets debossed with “20”on one side.
Maltese: ACOMPLIA 20 mg huwa fornit bħala pilloli bojod taħt forma ta' qatra dmugħ, u miksija b'rita, imnaqqxin bin-numru “20” fuq faċċata waħda.
English: Following multiple once-daily doses of 20 mg 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).
Maltese: Wara li ngħataw dożi repetuti ta' 20 mg darba kuljum lil suġġetti sajmin u b'saħħithom, il-livelli massimi ta' rimonabant fil-plażma intleħqu 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).
English: Limited data suggest an increased exposure in patients with moderate renal impairment (40% increase in AUC).
Maltese: Data limitata tissuġġerixxi espożżizjoni miżjuda f'pazjenti li għandhom indeboliment moderat tal-kliewi (40% żieda f'AUC).
English: 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 -0.3 under placebo (Difference -0.51 CI95% -0.78, -0.24 p< 0.001).
Maltese: 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 xhur kien -0.8 b'rimonabant 20 mg u -0.3 bil-plaċebo (Differenza -0.51 CI95% -0.78, -0.24 p<0.001).
English: The in vivo inhibitory effect on CYP2C8 has not been studied.
Maltese: L-effett inibitorju in vivo fuq is-sistema CYP2C8 ma kienx studjat.
English: In the limited number of Black patients weight loss was less pronounced (mean difference to placebo -2.9 kg).
Maltese: F'numru limitat ta' pazjenti Suwed, it-tnaqqis fil-piż kien anqas (differenza medja mal-plaċebo ta' -2.9 kg).
English: Animal data are inconclusive but suggest possible deleterious effects on embryonal/foetal development (see section 5.3).
Maltese: Id-data fl-annimali mhumiex konklussivi iżda jissuġerixxu li jista' jkollu possibbilment jagħmel ħsara fuq l-iżvilupp ta' l-embriju/fetu (ara sezzjoni 5.3).
English: 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).
Maltese: Id-differenza medja ta' bidla fil-piz tal-ġisem bejn il-gruppi ta' 20mg u lplaċebo kien ta' 3.8 kg (CI95% -5.0, -2.6 p<0.001).
English: Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(see section 4.5).
Maltese: (bhal ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone); ara sezzjoni 4.5.
English: Common side effects, that affect more than 1 per 100 but less than1 per 10, that have occurred in patients on ACOMPLIA include: upset stomach, vomiting, trouble with sleeping, nervousness, depression, irritability, dizziness, diarrhoea, anxiety, itching, excessive sweating, muscle cramps or spasm, fatigue, bruising, tendon pain and inflammation (tendonitis), memory loss, back pain (sciatica), altered sensitivity (less sensitivity or abnormal burning or prickling sensation) of the hands and feet, hot flush, fall, influenza, and joint sprain.
Maltese: Stonku mqalleb, rimettar, problemi fl-irqad, nervożiżmu, depressjoni, irritabilità, sturdament, dijarrea, anzjetà, ħakk, tagħriq eċċessiv, bugħawwieġijiet u spażmu tal-muskoli, għejja, tbenġil, uġigħ fl-għeruq u infjammazzjoni tagħhom (tendonitis), tnaqqis fil-memorja, uġigħ fid-dahar (xjatika), tibdil fil-ħass (inqass ħass jew sensazzjoni abnormali ta' ħruq jew tingiż) ta' l-idejn u s-saqajn, sħanat, waqgħat, linfluwenza u tfekkik ta'ġog.
English: For 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).
Maltese: HDL-C 1.24 mmol/l), meta mqabbla ma' żieda ta' 8.9% bil-plaċebo (linja bażi
English: Weight loss at two years 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).
Maltese: It-tnaqqis fil-piż ma tmiem is-sentejn kien ta' 5.1 kg 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).