FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of severe headache, severe dizziness, and severe insomnia was low, but was higher in subjects treated with naltrexone / bupropion compared to subjects treated with placebo (severe headache: naltrexone / bupropion 1.1%, placebo 0.3%; severe dizziness: naltrexone / bupropion 0.6%, placebo 0.2%; severe insomnia: naltrexone / bupropion 0.4%, placebo <0.1%).
Maltese: L-inċidenza ta' uġigħ ta' ras sever, sturdament sever, u nuqqas ta' rqad sever kienet baxxa, imma kienet ogħla f'individwi trattati b'naltrexone / bupropion meta mqabbla ma' individwi trattati bi plaċebo (uġigħ ta' ras sever: naltrexone / bupropion 1.1%, plaċebo 0.3%: sturdament sever: naltrexone
English: Naltrexone / bupropion (-3.7%) was significantly (p<0.001) more efficacious than placebo (-1.7%) treatment in this population.
Maltese: trattament b'naltrexone / bupronine (-8.1%) meta mqabbla ma' plaċebo (-1.8%).
English: Excipient with known effect: Each prolonged-release tablet contains 73.2 mg of lactose (see section 4.4).
Maltese: Kull pillola miksija b'rita fiha 73.2 mg ta' lactose (ara sezzjoni 4.4).
English: Percentage (%) of Subjects Losing ≥5% and ≥10% of Body Weight from Baseline to Week 56 in
Maltese: Perċentwali (%) ta' Individwi li Tilfu ≥5% u ≥10% tal-Piż tal-Ġisem mil-Linja Bażi sa
English: Although citalopram is not primarily metabolised by CYP2D6, in one study, bupropion increased the Cmax and AUC of citalopram by 30% and 40%, respectively.
Maltese: Għalkemm citalopram mhux metabolizzat prinċipalment minn CYP2D6, fi studju wieħed, bupropion żied is-Cmax u l-AUC ta' citalopram bi 30% u 40%, rispettivament.
English: What Mysimba looks like and contents of the pack Mysimba prolonged-release tablets are blue, biconvex, round tablets debossed with “NB-890” on one side.
Maltese: Il-pilloli li jerħu l-mediċina malajr ta' Mysimba huma pilloli tondi ta' lewn blu, bikonvessi intaljati b'”NB-890” fuq naħa waħda.
English: In a subset of subjects, body composition was measured using dual energy X-ray absorptiometry (DEXA) (naltrexone / bupropion = 79 subjects and placebo = 45 subjects) and multislice computed tomography (CT) scan (naltrexone / bupropion = 34 subjects and placebo = 24 subjects).
Maltese: F'sottosett ta' individwi, l-għamla tal-ġisem tkejlet permezz ta' dual energy X-ray absorptiometry (DEXA) naltrexone / bupropion = 79 individwu u plaċebo = 45 individwu) u multislice computed tomography (CT) scan (naltrexone / bupropion) L-istima ta' DEXA turi li trattament b'naltrexone / bupropion kien assoċjat ma' tnaqqis akbar mil-linja bażi fix-xaħam totali tal-ġisem u fit tessut ta' adipose vixxerali milli minn tal-plaċebo.
English: • Patients with severe hepatic impairment (see sections 4.2 and 5.2) • Patients with end-stage renal failure (see sections 4.2 and 5.2)
Maltese: • Pazjenti b'falliment tal-kliewi tal-aħħar stadju '(ara sezzjonijiet 4.2 u 5.2)
English: Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303
Maltese: NB-301, NB-302 u NB-304 u mil-Linja Bażi għal Ġimgħa 28 fl-Istudju ta' Fażi 3 ta' NB-303.
English: At one year, the average weight loss (using LOCF methodology) among these Week 16 Responders who received naltrexone / bupropion was 11.3%, with 55% losing ≥10% bodyweight.
Maltese: Wara sena waħda, il-medja ta' piż mitluf (permezz tal-metodoloġija LOCF) fost dawk li Rrispondew sa Ġimgħa 16 u li rċevew naltrexone / bupropion kien hemm 11.3%, bi 55% jitilfu ≥10% tal-piż tal-ġisem.
English: • Medicines to treat depression (such as desipramine, venlafaxine, imipramine, paroxetine, citalopram) or other mental health problems (such as risperidone, haloperidol, thioridazine);
Maltese: citalopram) jew problemi oħra tas-saħħa mentali (bħal risperidone, haloperidol, thioridazine);
English: Taste disorders (B)
Maltese: Mhux komuni Spażmi (B)
English: Mean HbA1c change from baseline at week 56 was -0.63% for subjects treated with naltrexone / bupropion compared to subjects on placebo -0.14% (p<0.001).
Maltese: 63% għal individwi trattati b'naltrexone / bupropion meta mqabbla ma' individwi fuq plaċebo -0.14% (p<0.001).
English: Chills, Energy increased * Cases of suicidal ideation and suicidal behaviour have been reported during NB therapy (see section 4.4).
Maltese: Sirdat, Żieda fl-enerġija * Każijiet ta' ħsibijiet suwiċidali u mġieba suwiċidali ġew rapportati waqt terapija b'NB (ara sezzjoni 4.4).
English: • antihistamines (medicines to treat hayfever, itch, and other allergic reactions) that cause sleepiness (such as chlorphenamine); medicines to lower sugar levels in your blood (such as insulin, sulphonylureas such as glyburide or glibenclamide, and meglitinides such as nateglinide or repaglinide);
Maltese: • antistamini (mediċini li jikkuraw id-deni tal-ħuxlief, ħakk u reazzjonijiet allerġiċi oħra) li jikkawżaw ħedla (bħal chlorophenamine), mediċini li jbaxxu l-livell ta' zokkor fid-demm tiegħek (bħal insulina, sulphonylureas bħal glyburide jew glibenclamide, u meglitinides bħal nateglinide jew repaglinide);
English: Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of
Maltese: Mysimba hu indikat, bħala aġġuntiv għal dieta b'kaloriji mnaqqsa u żieda fl-attività fiżika, u għallġestjoni ta' piż f'pazjenti adulti (≥18-il sena) b'Indiċi tat-Toqol tal-Ġisem (Body Mass Index, BMI) ta'
English: Uncommon Blood bilirubin increased (N), Jaundice (B)
Maltese: Mhux komuni Żieda fil-bilirubin fid-demm (N), Suffejra (B)
English: Co-administration of bupropion with drugs that are metabolised by CYP2D6 isozyme including certain antidepressants (SSRIs and many tricyclic antidepressants, e.g. desipramine, imipramine, paroxetine), antipsychotics (e.g., haloperidol, risperidone and thioridazine), beta-blockers (e.g., metoprolol) and Type 1C antiarrhythmics (e.g., propafenone and flecainide), should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medicinal product.
Maltese: L-għoti fl-istess waqt ta' bupropion b'mediċini li huma metabolizzati bl-isoenzima ta' CYP2D6 li jinkludu ċertu andidepressanti (SSRIs u ħafna antidepressanti triċikliċi, eż. desipramine, imipramine, paroxetine), antipsikotiċi (eż., haloperidol, risperidone u thioridazine), imblokkaturi beta (eż metoprolol) u antiarritmiċi ta' Tip IC (eż., propafenone u flecainide) għandu jiġi avviċinat b'kawtela u għandu jinbeda fit-tarf l-aktar baxx tal-firxa dożali tal-prodott mediċinali li jingħata fl-istess waqt.
English: Bupropion is associated with a dose-related risk of seizures, with bupropion sustained release (SR) 300 mg yielding an estimated seizure incidence of 0.1%.
Maltese: Bupropion hu assoċjat ma' riskju relatat mad-doża għal attakki pupletiċi, b'bupropion ta' 300 mg li jerħi b'mod sostnut (sustained release, SR) jagħti inċidenza stmata ta' attakki pupletiċi ta' 0.1%.
English: Induction of emesis is not recommended.
Maltese: Induzzjoni ta' emesi mhix rakkomandata.
English: The medicinal product has two components: naltrexone, a mu-opioid antagonist, and bupropion, a weak inhibitor of neuronal dopamine and norepinephrine reuptake.
Maltese: Il-prodott mediċinali għandu żewġ komponenti: naltrexone, antagonista tal-loppju mu, u bupropion, impeditur dgħajjef tat-teħid mill-ġdid ta' dopamine newronali u ta' norepinephrine.
English: Mysimba has been shown to cause fits (seizures) in up to 1 in 1,000 patients (see also section 4).
Maltese: Mysimba ntwera li jikkaġuna attakki tal-qamar (attakki pupletiċi) f'pazjent 1 minn kull 1,000 (ara wkoll sezzjoni 4).
English: In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir 400 mg twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manner by 20 to 80%.
Maltese: (100 mg darbtejn kuljum jew 600 mg darbtejn kuljum) jew ritonavir 100 mg flimkien ma' lopinavir 400 mg darbtejn kuljum naqqsu l-esponiment ta' bupropion u l-metaboliti ewlenien tiegħu f'manjiera dipendenti mid-doża b'madwar 20 sa 80%.
English: Naltrexone / bupropion is contraindicated in patients currently dependent on chronic opioid or opiate agonist therapy (e.g., methadone), or patients in acute opiate withdrawal (see section 4.3).
Maltese: Naltrexone / bupropion huwa kontraindikat f'pazjenti li attwalment huma dipendenti fuq terapija talloppju kronika jew t'agonist tal-loppju (eż. methadone), jew pazjenti b'irtirar akut mil-loppju (ara sezzjoni 4.3).
English: Naltrexone / bupropion is contraindicated in patients with severe hepatic impairment, and not recommended in patients with moderate hepatic impairment (see sections 4.2 4.3, and 5.2).
Maltese: Naltrexone / bupropion hu kontraindikat f'pazjenti b'indeboliment tal-fwied sever, u mhux rakkomandat f'pazjenti b'indeboliment tal-fwied moderat (ara sezzjonijiet 4.2, 4.3, u 5.2).
English: Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses.
Maltese: Deni, riġidità muskolari, rabdomijolisi, pressjoni baxxa, sturdament, koma u falliment respiratorju ġew rapportati prinċipalment meta bupropion kien parti ta' dożi eċċessivi minn diversi mediċini.
English: Since bupropion is extensively metabolised, caution is advised when naltrexone / bupropion is co-administered with medicinal products known to induce CYP2B6 (e.g., carbamazepine, phenytoin, ritonavir, efavirenz) as these may affect the clinical efficacy of naltrexone / bupropion.
Maltese: Peress li bupropion huwa metabolizzat b'mod estensiv, huwa rakkomandat li tiġi eżerċitata kawtela meta naltrexone / bupropion jiġi amministrat fl-istess waqt bi prodotti mediċinali magħrufa li jinduċu CYP2B6 (eż. carbamazepine, phenytoin, ritonavir, efavirenz) peress li dawn jistgħu jaffettwaw leffikaċja klinika ta' naltrexone / bupropion.
English: Alternatively, treatment cessation might be considered (see sections 4.7 and
Maltese: Inkella, jista' jkun ikkunsidrat it-twaqqif tat-trattament (ara sezzjonijiet 4.7 u 4.8).
English: The ≥5% weight loss threshold at Week 16 had 86.4% positive predictive value and 84.8% negative predictive value for determining whether a subject treated with naltrexone / bupropion would achieve at least 5% weight loss at Week 56.
Maltese: Il-punt ta' riferiment ta' telf ta' ≥5% fil-piż tal-ġisem kellu valur ta' tbassir pożittiv ta' 86.4% u valur ta' tbassir negattiv ta' 84.
English: The tablets should preferably be taken with food (see section 5.2).
Maltese: Il-pilloli preferribilment jittieħdu mal-ikel (ara sezzjoni 5.2).
English: Plasma concentrations of bupropion and metabolites of bupropion following single-dose administration of 180 mg of bupropion as naltrexone / bupropion tablets are comparable to concentrations observed after single-dose administration of bupropion SR 150 mg; however, no study has been conducted that determined the concentrations of bupropion and metabolites of bupropion after repeated dosing of naltrexone / bupropion tablets compared to bupropion SR tablets.
Maltese: Ilkonċentrazzjonijiet ta' bupropion u l-metaboliti fil-plażma wara doża waħda ta' 180 mg ta' bupropion bħala pilloli ta' naltrexone / bupropion huma komparabbli ma' konċentrazzjonijiet osservati wara l għoti ta' bupropion SR 150 mg; madanakollu, ma sar l-ebda studju li jistabilixxi l-konċentrazzjonijiet ta' bupropion u l-metaboliti ta' bupropion wara dożi ripetuti ta' pilloli ta' naltrexone / bupropion meta mqabbla ma' pilloli ta' bupropion SR.
English: In patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion is two tablets (one tablet in the morning and one tablet in the evening) (see sections 4.4, 4.8 and 5.2).
Maltese: F'pazjenti b'indeboliment moderat jew sever tal-kliewi, id-doża massima rakkomandata ta' kuljum għal naltrexone/bupropion hi ta' żewġ pilloli (pillola waħda filgħodu u pilloli waħda filgħaxija) ''(ara sezzjonijiet 4.4, 4.8 u 5.2).
English: Patients with moderate renal impairment had a higher incidence of gastrointestinal and central nervous system-related adverse events, thus these patients generally had lower tolerability of naltrexone / bupropion at a total daily dose of 32 mg naltrexone hydrochloride / 360 mg bupropion hydrochloride, which is thought to be due to higher plasma concentrations of active metabolites.
Maltese: Pazjenti b'indeboliment tal-kliewi moderat kellhom inċidenza ogħla ta' każijiet marbuta mas-sistemi gastrointestinali u tas-sistema nervuża ċentrali, għalhekk dawn il-pazjenti ġeneralment kellhom tollerabilità mnaqqsa għal naltrexone / bupropion f'doża totali ta' kuljum ta' 32 mg naltrexone hydrochloride / 360 mg bupropion hydrochloride, li hu maħsub li hu minħabba konċentrazzjonijiet ogħla tal-metaboliti attivi fil-plażma.
English: Weight loss of at least 5% baseline body weight was observed more frequently for subjects treated with naltrexone / bupropion (31%) compared to placebo (12%) (Table 4).
Maltese: Telf fil-piż ta' mill-inqas 5% tal-linja bażi fil-piż tal-ġisem kien osservat aktar frekwentament f'individwi trattati b'naltrexone / bupropion (31%) meta mqabbla ma' plaċebo (12%) (Tabella 3).
English: Naltrexone (100 mg/kg/day, approximately 30 times the dose of naltrexone in naltrexone/bupropion on a mg/m2 basis) caused a significant increase in pseudo-pregnancy in the rat.
Maltese: Naltrexone (100 mg/kg/djum, madwar 30 darba d-doża ta' naltrexone f'naltrexone/bupropion fuq bażi ta' mg/m2) ikkaġuna żieda sinifikanti fi psewdo-tqala fil-far.
English: LS
Maltese: ISEM
English: Naltrexone / bupropion is not recommended in patients with moderate hepatic impairment (see sections 4.4 and 5.2).
Maltese: Naltrexone / bupropion mhux rakkomandat f'pazjenti b'indeboliment tal-fwied moderat (ara sezzjonijiet 4.4 u 5.2).
English: The metabolic pathway responsible for the formation of erythrohydrobupropion is unknown.
Maltese: Il passaġġ metaboliku responsabbli għall-formazzjoni ta' erythrohydrobupropion mhux magħruf.
English: A fertility study of bupropion in rats at doses up to 300 mg/kg/day, or 8 times the bupropion dose provided by naltrexone / bupropion revealed no evidence of impaired fertility.
Maltese: Studju dwar il-fertilità ta' bupropion fil-firien f'dożi sa 300 mg/kg/jum, jew 8 darbiet id-doża ta' bupropion fornuta minn naltrexone /bupropion ma wera l-ebda evidenza ta' indeboliment fil-fertilità.
English: The safety profile of naltrexone / bupropion (NB) summarised in Table 1 below is based on clinical studies performed with the fixed-dose combination (adverse reactions at an incidence of at least 0.1% and twice that of placebo).
Maltese: Reazzjonijiet avversi rapportati bil-kombinazzjoni ta' doża fissa Il-profil tas-sigurtà ta' naltrexone / bupropion (NB) miġbur fil-qosor f'Tabella 1 hawn taħt huwa bażat fuq studji kliniċi mwettqa fil-kombinazzjoni ta' doża fissa (reazzjonijiet avversi b'inċidenza ta' mill inqas 0.1% u darbtejn dik tal-plaċebo).
English: NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets
Maltese: IL-PRODOTT MEDIĊINALI Mysimba 8 mg/90 mg pilloli li jerħu l-mediċina bil-mod
English: As seen in Table 3, in the NB-301 study subjects had a mean percent body weight loss of -5.4% while receiving naltrexone / bupropion compared to -1.3% in placebo-treated subjects.
Maltese: Kif jidher f'Tabella 2, fl-istudju NB-301 individwi kellhom telf perċentwali medju fil-piż tal-ġisem ta' -5.4% waqt li kienu qed jirċievu naltrexone / bupropion meta mqabbla ma' -1.3% f'individwi trattati bi plaċebo.
English: - Rhabdomyolysis
Maltese: Frekwenza Reazzjoni Avversa
English: Similarly, efavirenz 600 mg once daily for two weeks reduced the exposure of bupropion by approximately 55% in healthy volunteers.
Maltese: Hekk ukoll, efavirenz 600 mg darba kuljum għal ġimagħtejn naqqas l-esponiment ta' bupropion b'madwar 55% fuq voluntiera b'saħħithom.
English: Jaw pain
Maltese: OĦRAJN
English: Faecal excretion is a minor elimination pathway.
Maltese: eliminazzjoni mhix magħrufa L-eliminazzjoni bl-ippurgar hija rotta ta' eliminazzjoni minuri.
English: Hepatotoxicity
Maltese: Attakki pupletiċi
English: Adverse reactions reported in subjects who received Naltrexone/Bupropion as a fixed-dose combination
Maltese: Reazzjonijiet avversi rapportati f'individwi li rċevew Naltrexone/Bupropion bħala kombinazzjoni ta' doża fissa
English: • excessive use of alcohol or addiction to cocaine or stimulants
Maltese: • użu eċċessiv t'alkoħol jew għal kokaina jew stimulanti
English: Naltrexone / bupropion has not been extensively evaluated in subjects with hepatic impairment.
Maltese: Naltrexone / bupropion ma ġiex ivvalutat b'mod estensiv f'individwi b'indeboliment tal-fwied.
English: Uncommon Visual disturbance (B)
Maltese: Mhux komuni Disturb fil-viżjoni (B)
English: The initial dose is usually one tablet (8 mg naltrexone hydrochloride / 90 mg bupropion hydrochloride) once a day in the morning.
Maltese: Id-doża tal-bidu tiegħek hi ta' pillola waħda (8 mg naltrexone hydrochloride / 90 mg bupropion hydrochloride) darba kuljum filgħodu.
English: - Coldness of extremities (hands, feet)
Maltese: - Ideat irrazzjonali (delużjonijiet) - Psikożi
English: Baseline mean BMI was 36 kg/m2 and mean waist circumference was 110 cm.
Maltese: Il-medja fil-linja bażi ta' BMI kienet ta' 36 kg/m2 u ċ-ċirkonferenza medja tal-qadd kienet ta' 110 ċm.
English: Since monoamine oxidase A and B inhibitors also enhance the catecholaminergic pathways, by a different mechanism from bupropion, naltrexone / bupropion must not be used with MAOI (see section 4.3).
Maltese: Peress li l-impedituri ta' monoamine oxidase A u B jiftħu aktar ir-rotot katekolaminerġiċi, b'mekkaniżmu differenti minn bupropion, naltrexone / bupropion m'għandux jintuża ma' MAOI (ara sezzjoni 4.3).
English: Naltrexone / bupropion is contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors, bupropion or naltrexone, patients undergoing acute alcohol or benzodiazepine withdrawal, patients currently dependent on chronic opioids, or opiate agonists (see Section 4.3).
Maltese: Naltrexone / bupropion huwa kontraindikat f'pazjenti li jirċievu trattament fl-istess waqt b'impedituri ta' monoamine oxidase, bupropion jew naltrexone, pazjenti li jkunu għaddejjin minn fażi ta' rtirar akut mill-alkoħol jew benzodiazepene, pazjenti attwalment dipendenti fuq opijojdi kroniċi, jew agonisti tal-loppju (ara Sezzjoni 4.3).
English: A patient should stop taking naltrexone / bupropion and consult a doctor if experiencing allergic or anaphylactoid/anaphylactic reactions (e.g., skin rash, pruritus, hives, chest pain, oedema, and shortness of breath) during treatment.
Maltese: bupropion u jikkonsulta tabib jekk jesperjenza reazzjonijiet allerġiċi jew anafilattojdi/anafilattiċi (eż. raxx tal-ġilda, ħakk. ħorriqija, uġigħ fis-sider, edema, u nifsijiet qosra) waqt it-trattament.
English: Musculoskeletal and Connective Tissue Disorders
Maltese: Disturbi Muskoluskeletriċi u tat-Tessuti
English: España Laboratorios Farmacéuticos ROVI, S.A.
Maltese: Bruno Farmaceutici S.p.A.
English: Elderly patients may be more sensitive to the central nervous system adverse reactions of naltrexone / bupropion.
Maltese: Pazjenti anzjani jistgħu jkunu aktar sensittivi għar-reazzjonijiet avversi ta' naltrexone / bupropion fuq is sistema nervuża ċentrali.
English: PharmaSwiss EOOD Teл.
Maltese: - Żomm dan il-fuljett.
English: Bruno Farmaceutici S.p.A. Tel. 800-781-623
Maltese: Tel. 800-781-623
English: Arthralgia, Groin pain, Myalgia, Rhabdomyolysis
Maltese: Artralġja, Uġigħ fil-groin, Mijalġja,
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara EXP.
English: Limited clinical data suggest a higher incidence of adverse reactions (e.g., nausea, vomiting, and neuropsychiatric adverse reactions - see section 4.8) in patients receiving bupropion concurrently with either levodopa or amantadine.
Maltese: Tagħrif kliniku limitat jissuġġerixxi inċidenza ogħla ta' reazzjonijiet avversi (eż. dardir, remettar, u reazzjonijiet avversi newropsikjatriċi - ara sezzjoni 4.8) f'pazjenti li jkunu qed jieħdu bupropion fl-istess waqt ma' levodopa jew amantadine.
English: • as treatment with naltrexone / bupropion may result in lowered glucose in patients with diabetes, the dose of insulin and/or oral diabetic medicinal products should be assessed to minimise the risk of hypoglycaemia, which could predispose patients to seizure
Maltese: • peress li trattament b'naltrexone / bupropion jista' jirriżulta fi glukosju mnaqqas f'pazjenti b'dijabete, id-doża ta' insulina u/jew prodotti mediċinali dijabetiċi għandha tiġi assessjata sabiex ir-riskju ta' ipogliċemija jitnaqqas, li jista' jippredisponi pazjenti għal attakki pupletiċi
English: Belgique/België/Belgien GOODLIFE Pharma SA/NV Tel. 0800-795-10
Maltese: GOODLIFE Pharma SA/NV Tel. 0800-795-10
English: Rare - may affect up to 1 in 1,000 people taking Mysimba with risk of having a fit.
Maltese: Rari - jistgħu jaffettwaw sa persuna 1 f'1000 li jieħdu Mysimba b'riskju ta' attakk tal-qamar.
English: Naltrexone / bupropion is contraindicated in end-stage renal failure (see section 4.3).
Maltese: Naltrexone / bupropion hu kontraindikat f'pazjenti b'indeboliment tal-fwied sever (ara sezzjoni 4.3).
English: Naltrexone was also negative in an in vivo mouse micronucleus assay.
Maltese: Naltrexone ta' riżultat negattiv ukoll flassaġġ ta' mikronukleju fil-ġurdien in vivo.
English: Naltrexone has been shown to have an embryocidal effect in rats dosed with 100 mg/kg/day of naltrexone (30 times the naltrexone / bupropion dose) prior to and throughout gestation, and in rabbits treated with 60 mg/kg/day of naltrexone (36 times the naltrexone / bupropion dose) during the period of organogenesis.
Maltese: naltrexone (30 darba d-doża ta' naltrexone / bupropion) qabel u waqt it-tqala, u fi fniek trattati b'60 mg/kg/jum ta' naltrexone (36 darba d-doża ta' naltrexone / bupropion) waqt il-perijodu ta'
English: Naltrexone / bupropion may be used with caution after chronic opioid use has been stopped for 7 to 10 days in order to prevent precipitation of withdrawal.
Maltese: Naltrexone / bupropion għandu jintuża b'kawtela wara li l-użu kroniku bil-loppju ikun twaqqaf għal 7 sa 10 ijiem sabiex jiġi evitat li jkun hemm preċipitazzjoni tal-irtirar mill-mediċina.
English: • Some medicines used to treat irregular heart rhythm (such as propafenone, flecainide);
Maltese: • Xi mediċini użati biex jittrattaw ir-ritmu irregolari tal-qalb (bħal propafenone, flecainide);
English: Change in Cardiovascular and Metabolic Parameters from Baseline to Week 56 in Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303
Maltese: Ġimgħa 56 fl-Istudji NB-301, NB-302 u NB-304 ta' Fażi 3 u mil-Linja Bażi sa Ġimgħa 26 fl-Istudju
English: The derived value for renal excretion of naltrexone after oral administration, adjusting for plasma protein binding, is 89 mL/min.
Maltese: Il-valur derivat għal eliminazzjoni mill-kliewi ta' naltrexone wara l-għoti orali, b'aġġustament għal rabta ta' proteini mal-plażma kien ta' 89 ml/min.
English: Chest pain, Peripheral coldness, Pyrexia
Maltese: Uġigħ fis-sider, Kesħa periferali, Deni
English: Because naltrexone and bupropion metabolic products are excreted in the urine and elderly people are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Maltese: Peress li prodotti metaboliċi ta' naltrexone u bupropion jiġu eliminati fl-awrina u persuni anzjani x'aktarx li jkollhom funzjoni tal-kliewi mnaqqsa, għandha tingħata attenzjoni fl-għażla taddoża, u jista' jkun utli li l-funzjoni tal-kliewi tiġi monitorata.
English: After you stop treatment with Mysimba you may be more sensitive to low doses of opiates (see “Do not take Mysimba”).
Maltese: Wara li twaqqaf it-trattament b'Mysimba għandek mnejn tkun sensittiv/a aktar għal dożi baxxi ta' loppju (ara “Tiħux Mysimba”).