FrancophonIA/ELRC3.0 huggingface dataset:
English: Tinnitus, Vertigo
Danish: Almindelig Tinnitus, vertigo Ikke almindelig
English: NAME OF THE MARKETING AUTHORISATION HOLDER Orexigen
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Orexigen
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.
Danish: Hos patienter med moderat (Child-Pugh-scorer på 7-9 [klasse B]) og svært (Child-Pugh-scorer på 10 eller højere [klasse C]) nedsat leverfunktion, blev der observeret stigninger i den maksimale koncentration af naltrexon på hhv. ~6 og ~30 gange for patienter med moderat og svært nedsat leverfunktion, mens stigningerne i bupropion var på ~2 gange for begge grupper.
English: • Medicines to treat depression (such as desipramine, venlafaxine, imipramine, paroxetine, citalopram) or other mental health problems (such as risperidone, haloperidol, thioridazine);
Danish: • Lægemidler til behandling af depression (såsom desipramin, venlafaxin, imipramin, paroxetin, citalopram) eller andre psykiske problemer (såsom risperidon, haloperidol, thioridazin)
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
Danish: Affektive lidelser, aggression, forvirret sindstilstand, vrangforestillinger, depression, desorientering, opmærksomhedsforstyrrelse, fjendtlighed, tab af libido, mareridt, paranoia, psykotiske lidelser, selvmordstanker*, selvmordsforsøg, selvmordsadfærd
English: Submission of final study report by 31
Danish: Indsendelse af endelig undersøgelses rapport inden 31. marts 2022
English: Gender and race: Pooled analysis of naltrexone / bupropion data revealed no meaningful gender or race-related differences in the pharmacokinetic parameters of bupropion or naltrexone.
Danish: Køn og race: Samlet analyse af naltrexon/bupropion data viser ingen meningsfulde køns- eller raceforskelle i de farmakokinetiske parametre for bupropion eller naltrexon.
English: Naltrexone was negative in the following in vitro genotoxicity studies: bacterial reverse mutation assay (Ames test), the heritable translocation assay, CHO cell sister chromatid exchange assay, and the mouse lymphoma gene mutation assay.
Danish: Naltrexon var negativ i de følgende in vitro-genotoksicitetsundersøgelser: bakteriel tilbagemutationstest (Ames test), arvelig translokationstest, CHO-celle søsterkromatid udvekslingsanalyse og muselymfom genmutationstest.
English: • Some medicines for Parkinson's disease (such as levodopa, amantadine or orphenadrine);
Danish: • Nogle lægemidler mod Parkinsons sygdom (såsom levodopa, amantadin eller orphenadrin)
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.
Danish: Naltrexon/bupropion blev evalueret for sikkerhed i fem dobbelt-blinde placebo-kontrollerede undersøgelser med 4754 overvægtige forsøgspersoner (3239 forsøgspersoner blev behandlet med naltrexon/bupropion og 1515 forsøgspersoner blev behandlet med placebo) i en behandlingsperiode op til 56 uger.
English: Drugs which require metabolic activation by CYP2D6 in order to be effective (e.g., tamoxifen), may have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion.
Danish: Lægemidler, der kræver metabolisk aktivering af CYP2D6 for at være effektive (fx. tamoxifen), kan have nedsat virkning ved samtidig administration med CYP2D6-hæmmere, såsom bupropion.
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.
Danish: Naltrexon (100 mg/kg/dag, ca. 30 gange dosis af naltrexon i naltrexon/bupropion på en mg/m2-basis) forårsagede en signifikant stigning i pseudo-graviditet hos rotter.
English: Due to the antagonistic effect of naltrexone at the opioid receptor, patients taking naltrexone / bupropion may not fully benefit from treatment with opioid-containing medicinal products, such as cough and cold remedies, antidiarrhoeal preparations and opioid analgesics.
Danish: På grund af naltrexons modsatrettede virkning på opioidreceptoren, så får patienter, der tager naltrexon/bupropion måske ikke fuldt ud gavn af behandling med opioid-indeholdende lægemidler, såsom midler mod hoste og forkølelse, midler mod diarré og smertestillende midler indeholdende opioider.
English: • Patients receiving concomitant administration of monoamine oxidase inhibitors (MAOI).
Danish: • Patienter, der får samtidig administration af monoaminoxidasehæmmere (MAO-hæmmere).
English: - Fits (seizures):
Danish: - Anfald (kramper):
English: HbA1c >8% (64 mmol/mol), HbA1c changes at endpoint were -1.1% and -0.5% for naltrexone / bupropion compared to placebo, respectively.
Danish: Hos forsøgspersoner med baseline HbA1c> 8 % (64 mmol/mol) var HbA1c-ændringer på endpoint henholdsvis -1.1 % og -0,5 % for naltrexon/bupropion sammenlignet med placebo.
English: Anaphylactoid/anaphylactic reactions characterized by symptoms such as pruritus, urticaria, angioedema, and dyspnoea requiring medical treatment have been reported in clinical trials with bupropion.
Danish: Anafylaktoide/anafylaktiske reaktioner karakteriseret ved symptomer såsom kløe, nældefeber, angioødem og dyspnø, der kræver medicinsk behandling, er blevet rapporteret i kliniske forsøg med bupropion.
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.
Danish: Den maksimale daglige dosis af kombineret brug af bupropion og naltrexon administreret i kliniske forsøg indeholdt 50 mg naltrexon-hydrochlorid og 400 mg bupropion-hydrochlorid.
English: Patients receiving opioid analgesics
Danish: Patienter, der får opioidanalgetika
English: No study has been performed comparing AUC or Cmax of naltrexone / bupropion prolonged-release tablets with bupropion PR or naltrexone IR administered as single agents in the multiple dose setting (i.e., under steady state conditions).
Danish: Der er ikke udført undersøgelser, der sammenligner AUC eller Cmax af naltrexon/bupropion depottabletter med bupropion depottablet eller naltrexon tablet med øjeblikkelig frigivelse administreret som enkeltstoffer i multiple doseringsrammer (dvs. under steady state forhold).
English: Genotoxicity:
Danish: Genotoksicitet:
English: • Patients with a history of bipolar disorder
Danish: • Patienter med tidligere bipolar lidelse
English: Naltrexone/bupropion is not recommended in patients over 75 years of age.
Danish: Naltrexon/bupropion anbefales ikke til patienter over 75 år.
English: Comparable results were seen in the NB-303 study, which was of similar design, with significant weight loss observed in naltrexone / bupropion -treated subjects compared to placebo at the Week 28 primary endpoint, and sustained through 56 weeks from baseline (Table 3).
Danish: Der blev set sammenlignelige resultater i NB-303-undersøgelsen, der er af tilsvarende type, med signifikant vægttab observeret i naltrexon/bupropion-behandlede forsøgspersoner sammenlignet med placebo ved uge 28 primært endpoint og opretholdt gennem 56 uger fra baseline (tabel 3).
English: In one study, subjects received 800 mg naltrexone hydrochloride daily (equivalent to 25 times the recommended daily dose of naltrexone / bupropion) for up to one week showing no evidence of toxicity.
Danish: I én undersøgelse fik forsøgspersoner 800 mg naltrexon daglig (svarende til 25 gange den anbefalede daglige dosis af naltrexon/bupropion) i op til en uge, hvor der ikke opstod tegn på toksicitet.
English: Tablet core: microcrystalline cellulose, hydroxypropyl cellulose, lactose anhydrous, lactose monohydrate (see section 2 “Mysimba contains lactose”), cysteine hydrochloride, crospovidone, magnesium stearate, hypromellose, edetate disodium, colloidal silicon dioxide, and indigo carmine aluminium lake (E132).
Danish: Tabletkerne: mikrokrystallinsk cellulose, hydroxypropylcellulose, vandfri laktose, laktosemonohydrat (se punkt 2 “Mysimba indeholder laktose”), cysteinhydrochlorid, crospovidon, magnesiumstearat, hypromellose, dinatriumedetat, kolloidt siliciumdioxid, og indigocarmin aluminium lake (E132).
English: Older People
Danish: Ældre
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).
Danish: Bivirkninger rapporteret med fast dosis kombinationen Sikkerhedsprofilen for naltrexon/bupropion (NB), der er sammenfattet i tabel 1 herunder, er baseret på kliniske forsøg udført med fastdosis-kombination (bivirkninger med en hyppighed på mindst 0,1 % og det dobbelte af placebo).
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.
Danish: Naltrexon har vist sig at have en embryocidt effekt hos rotter doseret med 100 mg/kg/dag naltrexon (30 gange naltrexon/bupropion dosis) forud for og i svangerskabet og hos kaniner behandlet med 60 mg/kg/dag naltrexon (36 gange naltrexon/bupropion dosis) i organogeneseperioden.
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.
Danish: Når naltrexon/bupropion blev givet med et fedtrigt måltid, så steg AUC og Cmax for naltrexon hhv. 2,1-fold og 3,7-fold og AUC og Cmax for bupropion steg hhv. 1,4-fold og 1,8-fold.
English: In a cardiovascular outcomes trial (CVOT) of patients at increased risk of a cardiovascular event, mean increases from baseline in systolic and diastolic blood pressure of approximately 1 mmHg compared to placebo were also observed.
Danish: kardiovaskulære udfald (cardiovascular outcomes trial, CVOT) med patienter med øget risiko for en kardiovaskulær hændelse blev der også set gennemsnitlig øgning i det systoliske og diastoliske blodtryk i forhold til baseline på cirka 1 mmHg sammenlignet med placebo.
English: Three of these studies (NB-301, NB-302 and NB-304) designated the primary endpoint at 56 weeks, and 1 study (NB-303) designated the primary endpoint at week 28, but continued for 56 weeks.
Danish: Tre af disse undersøgelser (NB-301, NB-302 og NB-304) havde primært endpoint i uge 56, og 1 undersøgelse (NB-303) havde primært endpoint i uge 28, men fortsatte i 56 uger.
English: In patients requiring intermittent opiate treatment, naltrexone / bupropion therapy should be temporarily discontinued and opiate dose should not be increased above the standard dose.
Danish: Hos patienter, der kræver intermitterende opiat-behandling, bør behandlingen med naltrexon/bupropion afbrydes midlertidigt, og opiat-dosis bør ikke øges over standarddosis.
English: Smokers: Pooled analysis of naltrexone / bupropion data revealed no meaningful differences in the plasma concentrations of bupropion or naltrexone in smokers compared to nonsmokers.
Danish: Rygere: Samlet data analyse af naltrexon/bupropion viste ingen relevante forskelle i plasmakoncentrationen af bupropion eller naltrexon hos rygere sammenlignet med ikke-rygere.
English: Since bupropion is extensively metabolised, caution is advised when naltrexone / bupropion is co-administered with medicinal products known to inhibit metabolism (e.g. valproate), as these may affect its clinical efficacy and safety.
Danish: Da bupropion metaboliseres i stor udstrækning, så tilrådes der forsigtighed, når naltrexon/bupropion co-administreres med lægemidler, der er kendt for at hæmme metaboliseringen (fx. valproat), da disse kan påvirke den kliniske effekt og sikkerhed.
English: Ejaculation delayed (N)
Danish: Almindelig Forsinket ejakulation (N)
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.
Danish: Der blev set forbedringer i triglycerider, HDL-C og LDL-C/HDL-C-forhold i naltrexon/bupropion-behandlede forsøgspersoner, der var diagnosticerede med baseline dyslipidæmi uanset dyslipidæmi-behandling.
English: Due to these reasons, naltrexone / bupropion should be used with caution in patients over 65 years of age and is not recommended in patients over 75 years of age.
Danish: På grund af dette bør naltrexon/bupropion anvendes med forsigtighed hos patienter over 65 år og anbefales ikke til patienter over 75 år.
English: • Opiates and opiate-containing medicines for example to treat cough and cold (such as mixtures containing dextromethorphan or codeine), opiate addiction (such as methadone), pain (for example, morphine and codeine), diarrhoea (for example, paregoric).
Danish: • Opiater og opiat-lægemidler for eksempel til behandling af hoste og forkølelse (såsom blandinger, der indeholder dextromethorphan eller kodein), opiatafhængighed (såsom metadon), smerter (fx.morfin og kodein), diarré (fx. paregoric).
English: NB-303 included a re-randomization in a blinded manner and the addition of a higher dose of naltrexone (naltrexone hydrochloride 48 mg/bupropion hydrochloride 360 mg) at week 28 to half of the cohort of subjects in the active treatment arm who did not adequately respond to treatment, and as such the primary endpoint comparing weight change with 32 mg naltrexone hydrochloride /360 mg bupropion hydrochloride vs. placebo was evaluated at week 28.
Danish: NB-303 omfattede en re-randomisering på en blindet måde og tilføjelsen af en højere dosis af naltrexon (naltrexonhydrochlorid 48 mg/bupropionhydrochlorid 360 mg) i uge 28 til halvdelen af kohorten af forsøgspersoner i den aktive behandlingsdel, der ikke responderede på behandlingen, og som sådan blev det primære endpoint ved sammenligning af vægtændring med 32 mg naltrexonhydrochloris/360 mg bupropionhydrochlorid versus placebo evalueret i uge 28.
English: Naltrexone / bupropion should be used with caution in patients with active coronary artery disease (e.g., ongoing angina or recent history of myocardial infarction) or history of cerebrovascular disease.
Danish: Naltrexon/bupropion bør anvendes med forsigtighed til patienter med aktiv koronararteriesygdom (fx. vedvarende angina eller nyligt myokardieinfarkt) eller tidligere cerebrovaskulær sygdom.
English: The results of a single dose relative bioavailability study in healthy subjects demonstrated that naltrexone / bupropion tablets, when dose adjusted, are bioequivalent based on AUC0-∞ mean ratio and 90% confidence intervals to naltrexone immediate release (IR) or bupropion prolonged release (PR) administered as single agents.
Danish: Resultaterne af undersøgelse af en enkelt dosis-relativ biotilgængelighed hos raske forsøgspersoner viste, at naltrexon/bupropion tabletter, når de er dosis-justerede, er bioækvivalente baseret på AUC0-∞ gennemsnitlig ratio og 90 % konfidensintervaller for naltrexon tablet med øjeblikkelig frigivelse eller bupropion depottablet indgivet som enkeltstoffer.
English: Hyperhidrosis, Pruritus, Alopecia, Rash
Danish: Almindelig Hyperhidrose, pruritus, alopeci, udslæt Ikke kendt
English: • Monoamine oxidase inhibitors (medicines to treat depression or Parkinson's disease) such as phenelzine, selegiline, or rasagiline.
Danish: • Monoaminooxidasehæmmere (medicin til behandling af depression eller Parkinsons sygdom), såsom phenelzin, selegilin eller rasagilin.
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.
Danish: Co-administration af bupropion med lægemidler, der metaboliseres af CYP2D6-isoenzym, herunder visse antidepressiva (SSRI-præparater og mange tricykliske antidepressiva, fx. desipramin, imipramin, paroxetin), antipsykotika (fx. haloperidol, risperidon og thioridazin), beta-blokkere (fx. metoprolol) og type 1C antiarytmika (fx. propafenon og flecainid) bør foretages med forsigtighed, og der bør igangsættes i den lavere ende af dosisintervallet af det samtidige lægemiddel.
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);
Danish: • antihistaminer (lægemidler til behandling af høfeber, kløe og andre allergiske reaktioner), der forårsager søvnighed (som fx. klorfenamin), lægemidler der sænker sukker i blodet (såsom insulin, sulfonylurinstoffer som fx. glyburid eller glibenclamid, og meglitinider som fx. nateglinid eller repaglinid)
English: Naltrexone blocks the effects of opiates; if you take higher doses of opiates to overcome these effects of naltrexone, you may suffer from an acute opiate intoxication which may be life threatening.
Danish: Hvis du tager højere doser af opiater for at overvinde disse virkninger af naltrexon, kan du risikere en akut opiat-forgiftning, hvilket kan være livstruende.
English: If you forget to take Mysimba
Danish: Hvis du har glemt at tage Mysimba
English: Gastrointestinal adverse reactions: The vast majority of subjects treated with naltrexone / bupropion who experienced nausea reported the event within 4 weeks of starting treatment.
Danish: Gastrointestinale bivirkninger: Langt de fleste forsøgspersoner, der blev behandlet med naltrexonbupropion og som fik kvalme, rapporterede tilfældet inden for 4 uger efter behandlingens start.
English: In a clinical study, naltrexone / bupropion (32 mg naltrexone hydrochloride /360 mg bupropion hydrochloride daily) was co-administered with a 50 mg dose of metoprolol (a CYP2D6 substrate).
Danish: I en klinisk undersøgelse blev naltrexon/bupropion (32 mg naltrexonhydrochlorid/360 mg bupropionhydrochlorid dagligt) co-administreret med en dosis på 50 mg metoprolol (et CYP2D6substrat).
English: Early, transient mean increases from baseline in systolic and diastolic blood pressure of up to 1 mmHg were observed in naltrexone / bupropion Phase 3 clinical trials.
Danish: Der blev tidligt observeret forbigående gennemsnitlig øgning fra baseline i det systoliske og diastoliske blodtryk på op til 1 mm Hg i fase 3 kliniske forsøg med naltrexon/bupropion.
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.
Danish: En fertilitetsundersøgelse af bupropion hos rotter ved doser på op til 300 mg/kg/dag eller 8 gange bupropiondosis forudsat af naltrexon/bupropion viste ingen tegn på nedsat fertilitet.
English: No activation of mania or hypomania was reported in the clinical trials evaluating effects of naltrexone / bupropion in obese subjects, which excluded subjects receiving antidepressants.
Danish: Der blev ikke rapporteret om mani eller hypomani i de kliniske forsøg, der vurderer effekten af naltrexon/bupropion hos svært overvægtige, hvilket udelukkede forsøgspersoner, der fik antidepressiva.
English: Overdose management
Danish: Håndtering af overdosis
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.
Danish: Co-administration af lægemidler, der kan hæmme metaboliseringen af bupropion via CYP2B6isoenzym (fx. CYP2B6-substrater: cyclophosphamid, ifosfamid og CYP2B6-hæmmere: orphenadrin, ticlopidin, clopidogrel), kan resultere i øgede bupropion plasmaniveauer og lavere niveauer af aktivt metabolit hydroxybupropion.
English: The safety and efficacy of naltrexone / bupropion in children and adolescents below 18 have not yet been established.
Danish: Naltrexons/bupropions sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Your doctor may also recommend stopping treatment if there are concerns about increased blood pressure, or other concerns with the safety or tolerability of this medicine.
Danish: forhøjet blodtryk eller andre bekymringer med dette lægemiddels sikkerhed eller tolerabilitet.
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%).
Danish: Tilsvarende var der et større gennemsnitligt vægttab fra baseline for naltrexon/bupropion-behandlede (-8,1 %) i forhold til undersøgelsen NB-301 (-5,4%) ved uge 56 og for placebo (-4.9 %) sammenlignet med undersøgelse NB-301 (-1,3 %).
English: Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the CYP2B6 isozyme.
Danish: Bupropion metaboliseres primært til dets aktive hovedmetabolit hydroxybupropion af CYP2B6isozymet.
English: The percentages of subjects with ≥ 5% or ≥ 10% body weight loss from baseline were greater with naltrexone / bupropion compared to placebo in all four Phase 3 obesity trials (Table 4).
Danish: Procentdelen af forsøgspersoner med ≥5 % eller ≥10 % vægttab fra baseline var større med naltrexon/bupropion sammenlignet med placebo i alle fire fase 3 overvægtsforsøg (tabel 4).
English: If chronic opiate therapy is required, naltrexone / bupropion treatment must be stopped.
Danish: Hvis kronisk opiat-behandling er påkrævet, så skal behandling med naltrexon/bupropion stoppes.
English: Naltrexone administered orally to rats caused a significant increase in pseudopregnancy and a decrease in pregnancy rates at approximately 30 times the naltrexone dose provided by naltrexone / bupropion.
Danish: Naltrexon indgivet oralt til rotter forårsagede en signifikant stigning i pseudodrægtighed og et fald i drægtighedsrater ved cirka 30 gange naltrexondosis fra naltrexon/bupropion.
English: If you stop taking Mysimba
Danish: Hvis du holder op med at tage Mysimba
English: • you have any liver problems before you start Mysimba.
Danish: • du har nogen form for leverproblemer, før du starter med Mysimba.
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.
Danish: Forekomsten af krampeanfald hos forsøgspersoner, der fik naltrexon/bupropion i kliniske undersøgelser var ca. 0,06 % (2/3239 forsøgspersoner) vs. 0,0 % (0/1515 patienter) på placebo.
English: In naltrexone / bupropion completed clinical studies, where naltrexone hydrochloride daily doses ranged from 16 mg to 48 mg, drug-induced liver injury (DILI) was reported.
Danish: I afsluttede kliniske studier med naltrexon/bupropion, hvor daglige doser af naltrexonhydrochlorid varierede fra 16 mg til 48 mg, blev der rapporteret lægemiddelinduceret leverskade (DILI).
English: Adverse reactions of the individual components Naltrexone and Bupropion identified in the respective approved SmPCs.
Danish: Bivirkninger af de enkelte komponenter naltrexon og bupropion identificeret i de respektive godkendte produktresuméer.