FrancophonIA/ELRC3.0 huggingface dataset:
English: A meta-analysis of placebo-controlled clinical trials of antidepressants in adult subjects with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in subjects less than 25 years old.
Maltese: Meta-analiżi ta' provi kliniċi kontrollati bi plaċebo ta' antidepressanti f'individwi adulti b'disturbi psikjatriċi wriet riskju akbar ta' mġieba suwiċidali b'antidepressanti meta mqabbla ma' plaċebo f'individwi li għandhom inqas minn 25 sena.
English: Bupropion and its metabolites inhibit CYP2D6.
Maltese: Bupropion u l-metaboliti tiegħu jimpedixxu CYP2D6.
English: Naltrexone / bupropion has not been studied in conjunction with alpha-adrenergic blockers or clonidine.
Maltese: Naltrexone / bupropion ma ġiex studjat flimkien ma' imblokkaturi alfa-adrenerġiċi jew clonidine.
English: Other major metabolic routes are the formation of the metabolites 2-hydroxy-3-O-methyl naltrexone and 2-hydroxy-3-O-methyl-6-beta-naltrexol, believed to be mediated by catechol-O-methyl transferases (COMT), and glucuronidation, thought to be mediated by UGT1A1 and UGT2B7.
Maltese: Il-passaġġi metaboliċi maġġuri huma l-formazzjoni talmetaboliti 2-hydroxy-3-O-methyl naltrexone u 2-hydroxy-3-O-methyl-6-beta-naltrexol, li huma maħsuba li huma medjati permezz ta' catechol-O-methyl transferases (COMT), u glukuronidazzjoni, li hu maħsub li jsir permezz ta' UGT 1A1 u UGT 2B7.
English: Table 1.
Maltese: Tabella 1
English: • Patients with a history of bipolar disorder
Maltese: • Pazjenti bi storja ta' disturb bipolari
English: The major metabolite of naltrexone is 6-beta-naltrexol.
Maltese: Il-metabolit ewlieni ta' naltrexone hu 6-beta naltrexol.
English: Bupropion and its metabolites competitively inhibit the OCT2 in the basolateral membrane of the renal tubule responsible for creatinine secretion, in a manner similar to the OCT2 substrate cimetidine.
Maltese: Bupropion u l-metaboliti tiegħu jimpedixxu kompetittivament l-OCT2 fir-rita basolaterali tat-tubu talkliewi responsabbli mit-tnixxija għal kreatinina, f'manjiera simili għas-sottostrat ta' OCT2 cimetidine.
English: In contrast, formation of threohydrobupropion has been reported in the literature to be mediated by 11-beta-hydroxysteroid dehydrogenase 1.
Maltese: B'kuntrast, fil-letteratura medika ġie rrapportat li l-formazzjoni ta' threohydrobupropion ssir permezz ta' 11-beta-hydroxysteroid dehydrogenase 1.
English: Naltrexone / bupropion was evaluated for safety in five double-blind placebo-controlled studies in 4,754 overweight or obese subjects (3,239 subjects treated with naltrexone / bupropion and 1,515 subjects treated with placebo) for a treatment period up to 56 weeks.
Maltese: Naltrexone / bupropion ġew evalwati għas-sigurtà f'ħames studji double-blind bil-plaċebo bħala kontroll fost 4,754 individwu b'piż żejjed jew obeżi (3,239 individwu trattati b'naltrexone / bupropion u 1,515-il individwu trattati bi plaċebo) għal perijodu ta' trattament ta' 56 ġimgħa.
English: Baseline (kg)
Maltese: (kg)
English: The incidence of seizure in subjects receiving naltrexone / bupropion in clinical trials was approximately 0.06% (2/3239 subjects) vs. 0.0% (0/1515 subjects) on placebo.
Maltese: L-inċidenza ta' puplesija f'individwi li qed jirċievu naltexone / bupropion fil-provi kliniċi kienet ta' madwar 0.06% (2/3239 individwu) vs 0.0% (0/1515-il individwu) fuq plaċebo.
English: There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Mysimba.
Maltese: Kien hemm rapporti ta' depressjoni, ħsibijiet suwiċidali, u tentattivi ta' suwiċidju waqt ittrattament b'Mysimba.
English: Metabolism and Nutrition Disorders
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: In patients with moderate (Child-Pugh scores of 7-9 [Class B]) and severe (Child-Pugh scores of 10 or higher [Class C]) hepatic impairment, increases in the maximum concentration of naltrexone of ~6and ~30-fold were observed for the moderate and severe patients respectively, while increases in bupropion were ~2-fold for both groups.
Maltese: F'pazjenti b'indeboliment tal-fwied moderat (punteġġi ta' Child-Pugh ta' 7-9 [Klassi B]) u sever (punteġġi ta' Child-Pugh ta' 10 jew ogħla [Klassi C]), ġew osservati żidiet fil-konċentrazzjoni massima ta' naltrexone ta' ~6 u ~30 darba għall-pazjenti moderati u severi, rispettivament, filwaqt li ż-żidiet f'bupropion kienu ta' darbtejn għaż-żewġ gruppi.
English: • if you regularly drink alcohol (see “Mysimba with alcohol”);
Maltese: • jekk tixrob l-alkoħol regolarment (ara “Mysimba mal-alkoħol”);
English: The bupropion Cmax from naltrexone / bupropion (180 mg bupropion hydrochloride) was equivalent to the Cmax of bupropion PR (150 mg bupropion hydrochloride), indicating that the bupropion Cmax achieved with naltrexone / bupropion (360 mg bupropion hydrochloride /day) is comparable to that achieved with commercially available bupropion PR (300 mg bupropion hydrochloride /day) administered alone.
Maltese: Is-Cmax ta' bupropion minn naltrexone / bupropion (180 mg bupropion hydrochloride) kien ekwivalenti għas-Cmax ta' bupropion PR (150 mg bupropion hydrochloride), li jindika li l-kisba tas-Cmax ta' bupropion b'naltrexone / bupropion (360 mg bupropion hydrochloride/jum) hu komparabbli ma' dak miksub bi bupropion PR disponibbli kummerċjalment (300 mg bupropion hydrochloride/jum) mogħti waħdu.
English: • quinolones (antibiotics such as ciprofloxacine to treat infections);
Maltese: • quinolones (antibijotiċi bħal ciprofloxacine li jittrattaw infezzjonijiet)
English: • Some medicines used to treat cancer (such as cyclophospamide, ifosphamide, tamoxifen);
Maltese: • Xi mediċini użati biex jittrattaw il-kanċer (bħal cyclosphospamide, ifosphamide, tamoxifen);
English: • Medicines used to treat epilepsy such as valproate, carbamazepine, phenytoin or phenobarbital.
Maltese: • Mediċini użati biex jikkuraw l-epilessija bħal valproate, carbamazepine, phenytoin jew phenobarbital
English: Full analysis set+
Maltese: Sett ta' analiżi kompluta+
English: The effects of naltrexone / bupropion on weight loss, weight maintenance, waist circumference, body composition, obesity-related markers for cardiovascular and metabolic parameters and patient reported assessments were examined in double-blind, placebo-controlled obesity Phase 2 and Phase 3 trials (BMI range 27-45 kg/m2) with study durations of 16 to 56 weeks randomised to naltrexone hydrochloride (16 to 50 mg/day) and/or bupropion hydrochloride (300 to 400 mg/day) or placebo.
Maltese: L-effetti ta' neltrexone / bupropion fuq it-telf ta' piż, żamma tal-piż, ċirkonferenza tal-qadd, għamla tal-ġisem, markaturi marbuta mal-obeżità għal parametri kardjovaskulari u metaboliċi u stimi rapportati mill-pazjent ġew eżaminati fi provi double-blind tal-obeżita ta' Fażi 2 u ta' Fażi 3, bilplaċebo bħala kontroll (firxa ta' BMI ta' 27-45 kg/m2) bi studji li damu sejrin minn 16 sa 56 ġimgħa li kienu magħżula b'mod każwali għal naltrexone hydrochloride (16 sa 50 mg/jum) u/jew bupropion hydrochloride (300 sa 400 mg/jum) jew plaċebo.
English: Indigo Carmine Aluminium Lake (E132) 6.2 Incompatibilities Not applicable.
Maltese: Indigo Carmine Aluminium Lake (E132)
English: Co-administration of medicinal products that may inhibit the metabolism of bupropion via CYP2B6 isoenzyme (e.g., CYP2B6 substrates: cyclophosphamide, ifosfamide, and CYP2B6 inhibitors: orphenadrine, ticlopidine, clopidogrel), may result in increased bupropion plasma levels and lower levels of active metabolite hydroxybupropion.
Maltese: L-għoti fl-istess waqt ta' prodotti mediċinali li jistgħu jimpedixxu l-metaboliżmu ta' bupropion permezz tal-isoenzima CYP2B6 (eż., sottostrati ta' CYP2B6, cyclophosphamide, lfosfamide u impediituri ta' CYP2B6, orphenadrine, ticlopidine, clopidogrel) jista' jirriżulta f'livelli ogħla ta' bupropion fil-plażma u livelli aktar baxxi tal-metabolit attiv hydroxybupropion.
English: - Fits (seizures):
Maltese: - Ħorriqija (urtikarja)
English: Uncommon Hypersensitivity, Urticaria Rare
Maltese: Sensittività eċċessiva, Urtikarja
English: Affective disorders, Aggression, Confusional state, Delusions, Depression, Disorientation, Disturbance in attention, Hostility, Loss of libido, Nightmares, Paranoia, Psychotic disorder, Suicidal ideation*, Suicide attempt, Suicidal behaviour
Maltese: Disturbi affettivi, Aggressjoni, Stat konfużjonali, Delużjonijiet, Depressjoni, Diżorjentazzjoni, Disturb fl-attenzjoni,
English: PharmaSwiss d.o.o.
Maltese: PharmaSwiss Hellas A.E.
English: Degree of hepatic impairment should be assessed using the Child-Pugh score.
Maltese: Il-grad tal-indeboliment tal-fwied għandu jiġi vvalutat permezz tal-punteġġ ta' Child-Pugh.
English: Naltrexone / bupropion was also evaluated in combination with intensive behavioural modification counseling in the NB-302 study.
Maltese: Naltrexone / bupropion ġie evalwat ukoll f'kombinazzjoni ma' counseling fil-modifika intensiva flimġieba fl-istudju NB-302.
English: Other medicines and Mysimba
Maltese: Mediċini oħra u Mysimba
English: Similar clinical drug interactions resulting in increased pharmacokinetic exposure of CYP2D6 substrates have also been observed with bupropion as a single medicinal product with desipramine and venlafaxine.
Maltese: Interazzjonijiet kliniċi simili tal-mediċina li rriżultaw f'żieda fl-esponiment farmakokinetiku ta' sottostrati ta' CYP2D6 ġew osservati wkoll b'bupropion bħala prodott mediċinali uniku ma' desipramine u venlafaxine.
English: • Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: • you have any liver problems before you start Mysimba.
Maltese: • għandek problemi fil-kliewi qabel ma tibda tieħu Mysimba.
English: There are no known pharmacokinetic interactions between naltrexone and alcohol.
Maltese: M'hemmx interazzjonijiet farmakokinetiċi magħrufa bejn naltrexone u alkoħol.
English: Cough, Dysphonia, Dyspnoea, Nasal congestion, Nasal discomfort, Oropharyngeal pain, Rhinorrhea, Sinus disorder, Sneezing, Yawning
Maltese: Sogħla, Disfonija, Dispnea, Konġestjoni nażali, Skonfort nażali, Uġigħ orofarinġeali, Rinorea, Disturb fis-sinus, Għatis, Titwib
English: When naltrexone / bupropion was given with a high-fat meal the AUC and Cmax for naltrexone increased 2.1-fold and 3.7-fold and the AUC and Cmax for bupropion increased 1.4-fold and 1.8-fold, respectively.
Maltese: Meta naltrexone / bupropion ingħata ma' ikla b'ħafna xaħam, l-AUC u s-Cmax għal naltrexone żdiedu 2.1 darbiet u 3.7 darbiet u l-AUC u s-Cmax għal bupropion żdiedu b'1.4 darbiet u 1.8 darbiet, rispettivament.
English: Neuropsychiatric symptoms and activation of mania Activation of mania and hypomania have been reported in patients with mood disorders who were treated with other similar medicinal products for major depressive disorder.
Maltese: L-attivazzjoni ta' manija u ipomanija ġiet irrapportata f'pazjenti b'disturbi fil-burdata li kienu trattati bi prodotti mediċinali oħra simili għal disturb depressiv maġġuri.
English: NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride
Maltese: TAL-PRODOTT MEDIĊINALI Mysimba 8 mg/90 mg pilloli li jerħu l-mediċina bil-mod naltrexone hydrochloride / bupropion hydrochloride
English: These components affect two principal areas of the brain, specifically the arcuate nucleus of the hypothalamus and the mesolimbic dopaminergic reward system.
Maltese: Dawn il-komponenti jaffettwaw żewġ żoni prinċipali tal-moħħ, speċifikament in-nukleju arkuate tal ipotalamu u l-mesolimbic dapaminergic reward system.
English: Improvements in triglycerides, HDL-C and LDL-C/HDL-C ratio were seen in naltrexone / bupropion-treated subjects diagnosed with baseline dyslipidaemia irrespective of dyslipidaemia treatment.
Maltese: Titjib fi trigliċeridi, HDL-C u l-proporzjon LDL-C/HDL-C ġie osservat f'individwi trattati b'naltrexone / bupropion iddijanjostikati b'dislipidemija fil-linja bażi irrispettivament mit-trattament ta' dislipidemija.
English: Ejaculation delayed (N)
Maltese: Eġakulazzjoni mdewma (N)
English: Of the overall population of 4,536 subjects in the naltrexone / bupropion Phase 3 studies, 25% had hypertension, 33% had fasting glucose levels ≥100 mg/dL (5.6 mmol/L) at baseline, 54% had dyslipidaemia at study entry, and 11% had type 2 diabetes.
Maltese: kellhom pressjoni għolja, 33% kellhom livelli ta' glukosju ta' sawm ≥100 mg/dL (5.6 m/mol/L) fil linja bażi, 54% kellhom dislipidemija mad-dħul fl-istudju, u 11% kellhom dijabete ta' tip 2.
English: - Keep this leaflet.
Maltese: Barra minn hekk.
English: HbA1c >8% (64 mmol/mol), HbA1c changes at endpoint were -1.1% and -0.5% for naltrexone / bupropion compared to placebo, respectively.
Maltese: F'individwi b'linja bażi fl-HbA1c >8% (64 mmol/mol), bidliet fl-HbA1c fil-punt aħħari kienu ta' -1.1% u -0.5%
English: • Patients receiving concomitant administration of monoamine oxidase inhibitors (MAOI).
Maltese: • Pazjenti li jkunu qed jieħdu fl-istess waqt impedituri ta' monoamine oxidase (MAOI).
English: Studies NB-301, NB-303, and NB-304 included periodic instruction from the study sites to reduce caloric intake and increase physical activity, while NB-302 included an intensive behavioral modification program consisting of 28 group counseling sessions over 56 weeks, as well as a prescribed rigorous diet and exercise regimen.
Maltese: NB-301, NB-303 u NB 304 kienu jinkludu istruzzjonijiet perijodiċi mis-siti tal-istudju sabiex jitnaqqas it-teħid ta' kaloriji u tiżdied l-attività fiżika, waqt li NB-302 kien jinkludi programm intensiv dwar il-modifikazzjoni fl-imġieba li kien jikkonsisti minn 28 sessjoni ta' counselling mifruxa fuq 56 ġimgħa, kif ukoll dieta rigoruża preskritta u programm ta' eżerċizzju.
English: The potential exists for a drug interaction between naltrexone / bupropion and drugs that induce or are substrates of the CYP2B6 isozyme.
Maltese: Jeżisti l-potenzjal għal interazzjoni mediċinali bejn naltrexone / bupropion u mediċini li jinduċu jew huma sottostrati tal-isoenzima CYP2B6.
English: • concomitant administration of medicinal products that may lower the seizure threshold, including antipsychotics, antidepressants, antimalarials, tramadol, theophylline, systemic steroids, quinolones and sedating antihistamines
Maltese: • l-għoti fl-istess waqt ta' prodotti mediċinali li jistgħu jnaqqsu l-punt ta' riferiment għal attakki pupletiċi, li jinkludu antipsikotiċi, antidepressanti, mediċini ta' kontra l-malarja, tramadol, theophylline, sterojdi sistemiċi, quinolones u antistaminiċi li jistgħu jraqqdu
English: Following oral administration of 200 mg of 14C-bupropion hydrochloride in humans, 87% and 10% of the radioactive dose were recovered in the urine and feces, respectively.
Maltese: Wara t-teħid mill-ħalq ta' 200 mg ta' 14C-bupropion hydrochloride fil-bniedem, 87% u 10% tad-doża radjoattiva kienu rkuprati fl-awrina u l-ippurgar, rispettivament.
English: Decreased appetite (N) Uncommon Anorexia (B), Blood glucose disturbances (B)
Maltese: Mhux komuni Anoressija (B), Disturbi fil-glucose fiddemm (B)
English: 6.5 Nature and contents of container PVC/PCTFE/PVC/Aluminium blisters.
Maltese: Folji ta' PVC/PCTFE/PVC/Aluminju Daqs tal-pakkett: 28, 112-il pillola.
English: Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2 mg of naltrexone, and 90 mg bupropion hydrochloride, equivalent to 78 mg of bupropion.
Maltese: Kull pillola fiha 8 mg naltrexone hydrochloride, ekwivalenti għal 7.2 mg ta' naltrexone, u 90 mg bupropion hydrochloride, ekwivalenti għal 78 mg ta' bupropion.
English: • Some medicines for Parkinson's disease (such as levodopa, amantadine or orphenadrine);
Maltese: • Xi mediċini għall-marda ta' Parkinson (bħal levodopa, amantadine jew orphenadrine);
English: There is an increased incidence of gastrointestinal disorders with higher age categories.
Maltese: disturbi gastrointestinali f'kategoriji ta' etajiet akbar.
English: The maximum daily dose of combined use of bupropion and naltrexone administered in clinical trials contained 50 mg naltrexone hydrochloride and 400 mg bupropion hydrochloride.
Maltese: Id-doża massima ta' kuljum ta' użu kombinat ta' bupropion u naltrexone mogħtija fil-provi kliniċi kienet tikkonsisti minn 50 mg naltrexone hydrochloride u 400 mg bupropion hydrochloride.
English: Plasma protein binding is not extensive for naltrexone (21%) or bupropion (84%) indicating low potential for drug interactions by displacement.
Maltese: Ir-rabta ta' proteini fil-plażma mhix estensiva għal naltrexone (21%) jew bupropion (84%) u dan jindika potenzjal baxx għal interazzjonijiet tal-mediċina bi spostjar.
English: Seizures
Maltese: Konnettivi
English: Seizures: The incidence of seizure in naltrexone / bupropion over the course of the clinical program was 0.06% (2/3239 subjects).
Maltese: L-inċidenza ta' attakki pupletiċi b'naltrexone / bupropion fuq il-kors tal-programm kliniku kien ta' 0.06% (2/3239 individwu).
English: Tinnitus, Vertigo
Maltese: Tinnite,Vertiġni
English: Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the CYP2B6 isozyme.
Maltese: Bupropion jiġi metabolizzat għal metabolit attiv ewlieni tiegħu hydroxybupropion prinċipalment blisoenzina CYP2B6.
English: Drugs metabolised by cytochrome P450 (CYP) enzymes Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the cytochrome P450 CYP2B6; thus, the potential exists for interaction when administered with medicinal products that induce or inhibit CYP2B6.
Maltese: Mediċini metabolizzati b'enzimi ta' cytochrome P450 (CYP) Bupropion hu metabolizzat għal metabolit attiv ewlieni hydoxybupropion prinċipalment minn cytochrome P450 CYP2B6, għalhekk, teżisti l-probabilità għal interazzjoni meta jingħata ma' prodotti mediċinali li jinduċu jew jimpedixxu CYP2B6.
English: Four multicentre, double-blind, placebo-controlled obesity Phase 3 studies (NB-301, NB-302, NB-303 and NB-304) were conducted to evaluate the effect of naltrexone / bupropion in conjunction with lifestyle modification in 4,536 subjects randomised to naltrexone/bupropion or placebo.
Maltese: (NB-301, NB-302, NB-303 u NB-304) biex jivvalorizzaw l-effett ta' naltrexone / bupropion flimkien ma' tibdil fl-istil ta' ħajja f'4,536 individwu magħżula b'mod każwali għal naltrexone/bupropion jew plaċebo.
English: Completers++ N
Maltese: Dawk li temmew++ N
English: At steady state, the food effect resulted in AUC and Cmax increases of 1.7- and 1.9-fold for naltrexone, and 1.1- and 1.3-fold for bupropion, respectively.
Maltese: Fl-istadju fiss, l-effett tal-ikel irriżulta f'żidiet fl-AUC u s-Cmax ta' 1.7 u 1.9 darbiet għal naltrexone, u 1.1 u 1.3 darbiet għal bupropion, rispettivament.
English: - if you have a condition that causes fits (seizures) or if you have a history of fits; - if you have a brain tumour; - if you are usually a heavy drinker and you have just stopped drinking alcohol, or are going to stop while you are taking Mysimba; - if you have recently stopped taking sedatives or medicines to treat anxiety (especially benzodiazepines), or if you are going to stop them while you are taking Mysimba; - if you have a bipolar disorder (extreme mood swings); - if you are using any other medicines which contain bupropion or naltrexone; - if you have an eating disorder or had one in the past (for example, bulimia or anorexia nervosa); - if you are currently dependent on chronic opiates or opiate agonists (for example methadone), or you are going through acute withdrawal (cold turkey); - if you are taking medicines for depression or Parkinson's disease called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days; - if you have severe liver disease; - if you have endstage kidney disease.
Maltese: - jekk għandek tumur f'moħħok; - jekk inti normalment tixrob ħafna u ma' waqaftx tixrob l-alkoħol, jew ser tieqaf tixrob waqt li qed tieħu Mysimba; - jekk riċentement waqaft tieħu l-kalmanti jew mediċini li jikkuraw l-ansjetà (speċjalment benzodiazepines), jew jekk ser tieqaf teħodhom waqt li qed tieħu Mysimba; - jekk għandek disturb bipolari (bidliet f'daqqa fil-burdata); - jekk qed tieħu xi mediċini oħra li jkun fihom bupropion jew neltrexone; - jekk għandek disturb dwar teħid ta' ikel jew kellek wieħed fil-passat (pereżempju, bulimja jew anoreksja nervosa) - jekk attwalment inti tiddependi fuq loppju jew agonisti tal-loppju b'mod kroniku (pereżempju methadone), jew jekk għaddej minn irtirar akut mill-mediċina (cold turkey); - jekk qed tieħu mediċini għal depressjoni jew il-marda ta' Parkinson li jissejħu monoamine oxidase inhibitors (MAOIs) jew tkun ħadthom fl-aħħar 14-il jum; - jekk għandek mard tal-fwied sever;
English: Loss
Maltese: OĦRA
English: At least 14 days should elapse between discontinuation of MAOI and initiation of treatment with naltrexone / bupropion (see section 4.5)
Maltese: Tal-anqas għandhom jgħaddu 14-il jum bejn il-waqfien ta' MAOI u l-bidu ta' trattament b'naltrexone / bupropion (ara sezzjoni 4.5)
English: Correspondingly, there was greater mean weight loss from baseline for naltrexone / bupropion treatment (-8.1%) compared to study NB-301 (-5.4%) at Week 56, and for placebo (-4.9%) compared to study NB-301 (-1.3%).
Maltese: Minn hekk joħroġ, li kien hemm telf aktar fil-piż medju mil-linja bażi għal trattament b'naltrexone / bupropion (-8.1%) meta mqabbel ma' studju NB-301 (-5.4%) f'Ġimgħa 56 u għal plaċebo (-4.9%) meta mqabbel ma' studju NB-301 (-1.3%).
English: Diarrhoea, Flatulence, Haemorrhoids , Ulcer
Maltese: Dijarea, Gass, Murliti, Ulċera
English: Naltrexone and its metabolites are excreted primarily by the kidney (37 to 60% of the dose).
Maltese: Naltrexone u l-metaboliti tiegħu jiġu eliminati prinċipalment mill-kliewi (37 sa 60% tad-doża).
English: The consumption of alcohol during naltrexone / bupropion treatment should be minimised or avoided.
Maltese: Il-konsum t'alkoħol waqt it-trattament b'naltrexone / bupropion għandu jiġi minimizzat jew evitat.
English: When α-MSH is released, POMC neurons simultaneously release β-endorphin, an endogenous agonist of the mu-opioid receptors.
Maltese: Meta α-MSH jiġi rilaxxat, newroni POMC simultanjament jirrilaxxaw β-endorphin, agonista endoġenu tar-riċettaturi talloppju mu.
English: • tramadol (a painkiller belonging to the class of opiates);
Maltese: • tramadol (mediċina li ttaffi l-uġigħ li tappartjeni għall-kategorija tal-loppju);
English: Naltrexone and 6-beta-naltrexol are not metabolised by cytochrome P450 enzymes and in vitro studies indicate that there is no potential for inhibition or induction of important isozymes.
Maltese: P450 u studji in vitro jindikaw li m'hemmx potenzjal għal impediment jew induzzjoni ta' isoenzimi importanti.
English: In the arcuate nucleus of the hypothalamus, bupropion stimulates pro-opiomelanocortin (POMC) neurons that release alpha-melanocyte stimulating hormone (α-MSH), which in turn binds to and stimulates melanocortin 4 receptors (MC4-R).
Maltese: Fin-nukleju arkuate tal-ipotalamu, bupropion jistimula newroni pro-opiomelancortin (POMC) li jirrilaxxaw l-ormon li jistimula l-melanoċite alpha (alpha-melanocyte stimulating hormone, α-MSH), li min-naħa tiegħu jintrabat ma' u jistimula r-riċettaturi melanocortin-4 (MCR-4).
English: Naltrexone and bupropion are well absorbed from the gastrointestinal tract (>90% absorbed), however, naltrexone has a significant first pass effect thereby limiting systemic bioavailablity, with only 5-6% reaching the systemic circulation intact.
Maltese: Naltrexone u bupropion jiġu assorbiti tajjeb fil-passaġġ gastroinetestinali (>90% assorbiti), madanakollu naltrexone għandu effett sinifikanti ta' first pass li minħabba f'hekk jillimita lbijodisponibilità sistemika, b'5-6% biss jilħaq iċ-ċirkolazzjoni b'mod intatt.