FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Za trigliceride, HDL-C in razmerje LDL-C/HDL-C so opazili izboljšave pri preiskovancih, zdravljenih z naltreksonom/bupropionom, ki so imeli diagnozo izhodiščne dislipidemije ne glede na zdravljenje dislipidemije.
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.
Slovenian: V končanih kliničnih študijah z naltreksonom/bupropionom, kjer so bili dnevni odmerki naltreksonijevega klorida v razponu od 16 mg do 48 mg, so poročali o poškodbah jeter, povzročenih z zdravili.
English: - Fits (seizures):
Slovenian: - krči (epileptični napadi):
English: Dose reduction is not necessary in patients with mild renal impairment.
Slovenian: Pri bolnikih z blago ledvično okvaro ni treba zmanjšati odmerka.
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.
Slovenian: Pokazalo se je, da ima naltrekson embriocidne učinke pri podganah, ki so prejemale naltrekson v odmerku 100 mg/kg/dan (30-kratnik odmerka kombinacije naltrekson/bupropion) pred in med gestacijo, ter pri kuncih, ki so prejemali naltrekson v odmerku 60 mg/kg/dan (36-kratnik odmerka kombinacije naltrekson/bupropion) v obdobju organogeneze.
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.
Slovenian: Študija NB-303 je vključevala ponovno slepo randomizacijo in dodajanje večjega odmerka naltreksona (48 mg naltreksonijevega klorida/360 mg bupropionijevega klorida) v 28. tednu pri polovici kohorte preiskovancev v skupini z aktivnim zdravljenjem, ki se niso ustrezno odzvali na zdravljenje, tako da je bil primarni cilj, kjer so primerjali spremembo telesne mase pri uporabi 32 mg naltreksonijevega klorida/360 mg bupropionijevega klorida oziroma pri uporabi placeba, ovrednoten v 28. tednu.
English: The safety and tolerability of naltrexone / bupropion should be assessed at regular intervals.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Varnost in prenašanje naltreksona/bupropiona je treba ocenjevati v rednih časovnih presledkih.
English: If chronic opiate therapy is required, naltrexone / bupropion treatment must be stopped.
Slovenian: Če se zahteva kronično zdravljenje z opiati, je treba ukiniti zdravljenje z naltreksonom/bupropionom.
English: Do not drive, use any tools or machines, or perform dangerous activities until you know how this medicine affects you.
Slovenian: Dokler ne veste, kako zdravilo vpliva na vaše zmožnosti, ne vozite, ne uporabljajte nobenih orodij ali strojev in ne izvajajte nevarnih dejavnosti.
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 (see section 4.4).
Slovenian: Pri bolnikih, ki potrebujejo občasno zdravljenje z opiati, je treba zdravljenje z naltreksonom/bupropionom začasno prekiniti, odmerka opiatov pa ni dovoljeno povečati nad standardni odmerek (glejte poglavje 4.4).
English: However, given the prolonged nature of the drug release for naltrexone / bupropion, Cmax for naltrexone was markedly reduced compared to the 50 mg naltrexone hydrochloride IR administered alone (about 2-fold difference after dose adjustment).
Slovenian: Vendar se je ob upoštevanju podaljšanega sproščanja naltreksona/bupropiona vrednost Cmax za naltrekson izrazito zmanjšala v primerjavi s samostojno uporabo tablet s takojšnjim sproščanjem, ki vsebujejo 50 mg naltreksonijevega klorida (približno 2-kratna sprememba po prilagoditvi odmerka).
English: The incidence of severe nausea, severe constipation, and severe vomiting was low, but was higher in subjects treated with naltrexone / bupropion compared to subjects treated with placebo (severe nausea: naltrexone / bupropion 1.9%, placebo <0.1%; severe constipation: naltrexone / bupropion 0.6%, placebo 0.1%; severe vomiting: naltrexone / bupropion 0.7%, placebo 0.3%).
Slovenian: Pojavnost hude navzee, hudega zaprtja in hudega bruhanja je bila majhna, vendar je bila pri preiskovancih, zdravljenih z naltreksonom/bupropionom, višja kot pri preiskovancih, ki so prejemali placebo (huda navzea: naltrekson/bupropion 1,9 %, placebo <0,1 %; hudo zaprtje: naltrekson/bupropion 0,6 %, placebo 0,1 %; hudo bruhanje: naltrekson/bupropion 0,7 %, placebo 0,3 %).
English: In patients with mild hepatic 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 and 5.2).
Slovenian: Pri bolnikih z blago jetrno okvaro je največji priporočeni dnevni odmerek za kombinacijo naltrekson/bupropion dve tableti (ena tableta zjutraj in ena tableta zvečer) (glejte poglavji 4.4 in 5.2).
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).
Slovenian: Primerljive rezultate so dobili v študiji NB-303, ki je bila podobno zasnovana, saj je bilo zmanjšanje telesne mase pri preiskovancih, zdravljenih z naltreksonom/bupropionom, izrazitejše kot v skupini, ki je prejemala placebo, pri primarnem cilju v 28. tednu in se je ohranilo do 56. tedna po začetku študije (Preglednica 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).
Slovenian: Kombinacija naltrekson/bupropion je kontraindicirana pri bolnikih, ki sočasno prejemajo zaviralce monoaminooksidaze, bupropion ali naltrekson, pri bolnikih, ki prestajajo akutno odtegnitev alkohola ali benzodiazepinov, ali bolnikih, ki so trenutno odvisni od kroničnega zdravljenja z opioidi ali opiatnimi agonisti (glejte poglavje 4.3).
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).
Slovenian: Odstotek preiskovancev, ki so zmanjšali telesno maso za ≥5 % ali ≥10 % glede na izhodiščno vrednost, je bil pri uporabi naltreksona/bupropiona večji kot pri uporabi placeba v vseh štirih preskušanjih 3. faze glede debelosti (Preglednica 4).
English: There were no differences in bioavailability, as measured by AUC, of naltrexone or bupropion when administered in combination compared to each administered alone.
Slovenian: Pri biološki uporabnosti (izmerjeni z AUC) naltreksona oziroma bupropiona pri kombinirani uporabi v primerjavi s samostojno uporabo niso ugotovili nobenih razlik.
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.
Slovenian: Neželeni učinki na prebavila: Velika večina preiskovancev, zdravljenih z naltreksonom/bupropionom, pri katerih se je pojavila navzea, je o dogodku poročala v prvih 4 tednih po začetku zdravljenja.
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).
Slovenian: Pri bolnikih z zmerno ali hudo ledvično okvaro je največji priporočeni dnevni odmerek kombinacije naltrekson/bupropion dve tableti (ena tableta zjutraj in ena tableta zvečer) (glejte poglavja 4.4, 4.8 in 5.2).
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Patients with type 2 diabetes treated with naltrexone / bupropion demonstrated a higher incidence of gastrointestinal adverse events, primarily nausea, vomiting, and diarrhoea, than subjects without diabetes.
Slovenian: Sladkorna bolezen tipa 2 Pri bolnikih s sladkorno boleznijo tipa 2, zdravljenih z naltreksonom/bupropionom, je bila pojavnost neželenih učinkov na prebavila, primarno navzee, bruhanja in driske, večja kot pri preiskovancih brez sladkorne bolezni.
English: In patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced, as these patients may have higher drug concentrations which could result in an increase in adverse drug reactions (see sections 4.2, 4.8, and 5.2).
Slovenian: Pri bolnikih z zmerno ali hudo ledvično okvaro je treba največji priporočeni dnevni odmerek kombinacije naltrekson/bupropion zmanjšati, saj je pri teh bolnikih koncentracija zdravila lahko višja, kar se lahko odraža v povečani pojavnosti neželenih učinkov (glejte poglavja 4.2, 4.8 in 5.2).
English: Approximately half of the subjects treated with naltrexone / bupropion who experienced vomiting first reported the event during the dose escalation phase.
Slovenian: Približno polovica preiskovancev, zdravljenih z naltreksonom/bupropionom, pri katerih se je pojavilo bruhanje, je o dogodku prvič poročala v fazi povečevanja odmerkov.
English: - Rhabdomyolysis
Slovenian: - rabdomioliza:
English: Uncommon Postural hypotension (B), Vasodilatation (B)
Slovenian: Občasni posturalna hipotenzija (B), vazodilatacija (B)
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%).
Slovenian: Pojavnost hudega glavobola, hude omotice in hude nespečnosti je bila majhna, vendar je bila pri preiskovancih, zdravljenih z naltreksonom/bupropionom, višja kot pri preiskovancih, ki so prejemali placebo (hud glavobol: naltrekson/bupropion 1,1 %, placebo 0,3 %; huda omotica: naltrekson/bupropion 0,6 %, placebo 0,2 %; huda nespečnost: naltrekson/bupropion 0,4 %,
English: Dry mouth may be associated with toothache and dental caries; in the subset of patients with dry mouth, a higher incidence of toothache and dental caries were observed in subjects treated with naltrexone / bupropion compared to subjects treated with placebo.
Slovenian: Pojav suhih ust je lahko povezan z zobobolom in zobnim kariesom; v podskupini bolnikov s suhimi usti so pri preiskovancih, zdravljenih z naltreksonom/bupropionom,
English: Uncommon Exacerbation of psoriasis (B), Seborrhea (N)
Slovenian: Bolezni kože in podkožja občasni poslabšanje psoriaze (B), seboreja (N)
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).
Slovenian: • opiati in zdravili, ki vsebujejo opiate, na primer za zdravljenje kašlja in prehlada (kot so mešanice, ki vsebujejo dekstrometorfan ali kodein), zasvojenosti z opiati (kot je metadon),
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.
Slovenian: Študija plodnosti za bupropion pri podganah, ki so prejemale odmerke do 300 mg/kg/dan oziroma 8-kratnik odmerka bupropiona, ki ga vsebuje kombinacija naltrekson/bupropion, ni pokazala nobenih znakov zmanjšane plodnosti.
English: The use of naltrexone/bupropion has been associated with somnolence and episodes of loss of consciousness, sometimes caused by seizure.
Slovenian: Vpliv na sposobnost vožnje in upravljanja strojev Uporaba naltreksona/bupropiona je bila povezana s somnolenco in epizodami izgube zavesti, ki so včasih lahko posledica epileptičnega napada.
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.
Slovenian: Kot je prikazano v Preglednici 2, so preiskovanci v študiji NB-301 zabeležili povprečno odstotno zmanjšanje telesne mase v vrednosti -5,4 % pri uporabi naltreksona/bupropiona v primerjavi z vrednostjo -1,3 % pri preiskovancih, ki so prejemali placebo.
English: NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets
Slovenian: Mysimba 8 mg/90 mg tablete s podaljšanim sproščanjem
English: There are no or limited amounts of data from the use of naltrexone / bupropion in pregnant women.
Slovenian: Podatkov o uporabi naltreksona/bupropiona pri nosečnicah ni oziroma so omejeni.
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.
Slovenian: Tablete zdravila Mysimba s podaljšanim sproščanjem so modre okrogle bikonveksne tablete, ki imajo na eni strani vtisnjeno oznako “NB-890”.
English: For patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced (see section 4.2).
Slovenian: Za bolnike z zmerno ali hudo okvaro ledvic je treba največji priporočeni dnevni odmerek kombinacije naltrekson/bupropion zmanjšati (glejte poglavje 4.2).
English: How to take Mysimba
Slovenian: Kako jemati zdravilo Mysimba
English: Very common side effects (may affect more than 1 in 10 people): - Feeling sick (nausea), being sick (vomiting) - Constipation - Headache
Slovenian: Med druge neželene učinke so vključeni: zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - občutek slabosti (navzea), bruhanje;
English: Mysimba is not recommended if you are over 75 years.
Slovenian: Če ste stari nad 75 let, se zdravilo Mysimba ne priporoča.
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).
Slovenian: Zmanjšanje telesne mase za najmanj 5 % izhodiščne telesne mase so pri preiskovancih, zdravljenih z naltreksonom/bupropionom (31 %), opazili pogosteje kot pri uporabi placeba (12 %) (Preglednica 3).
English: Due to the dose-related risk of seizures with bupropion, hospitalisation following suspected overdose with naltrexone / bupropion should be considered.
Slovenian: Zaradi od odmerkov odvisnega tveganja epileptičnih napadov pri uporabi bupropiona je treba po sumu na preveliko odmerjanje s kombinacijo naltrekson/bupropion razmisliti o hospitalizaciji.
English: For individuals who are at elevated risk for renal impairment, in particular, individuals with diabetes or elderly individuals, estimated glomerular filtration rate (eGFR) should be assessed prior to initiating therapy with naltrexone / bupropion.
Slovenian: Za posameznike, pri katerih je tveganje za ledvično okvaro povečano, še posebej za posameznike s sladkorno boleznijo ali starejše posameznike, je treba pred uvedbo zdravljenja z naltreksonom/bupropionom podati oceno hitrosti glomerulne filtracije (GFR - glomerulal filtration rate).
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.
Slovenian: substrati encima CYP2B6: ciklofosfamid, ifosfamid, in zaviralci encima CYP2B6: orfenadrin, tiklopidin, klopidogrel), lahko vodi do zvišanih plazemskih ravni bupropiona in znižanih ravni aktivnega presnovka hidroksibupropiona.
English: The MAH should conduct and submit results of a multicentre, randomised, doubleblind, placebo-controlled, phase 4 study to assess the effect of naltrexone extended release (ER) /bupropion ER on the occurrence of major adverse cardiovascular events (MACE) in overweight and obese subjects.
Slovenian: randomizirano, dvojno slepo, s placebom nadzorovano študijo 4. faze in predložiti njene rezultate za ocenitev vpliva naltreksona s podaljšanim sproščanjem/bupropiona s podaljšanim sproščanjem na pojav hudih srčnožilnih neželenih učinkov (MACE) pri preiskovancih s čezmerno telesno maso in debelih preiskovancih.
English: Naltrexone / bupropion increased metoprolol AUC and Cmax by approximately 4- and 2-fold, respectively, relative to metoprolol alone.
Slovenian: Zaradi naltreksona/bupropiona sta se vrednosti AUC in Cmax za metoprolol povečali, in sicer vrednost AUC približno 4-kratno glede na samostojno uporabo metoprolola,
English: This incidence of seizure, along with incidence of seizure in subjects who received naltrexone / bupropion in a large cardiovascular outcomes trial (CVOT), was no higher than the seizure rate with bupropion as a single agent at approved doses.
Slovenian: Ta pojavnost epileptičnih napadov, skupaj s pojavnostjo epileptičnih napadov pri preiskovancih, ki so prejemali naltrekson/bupropion v velikem preskušanju, v katerem so preučevali kardiovaskularne izide, ni večja kot pojavnost epileptičnih napadov pri uporabi bupropiona kot samostojnega zdravila z odobrenimi odmerki.
English: Naltrexone / bupropion should not be used during breast-feeding.
Slovenian: Kombinacija naltrekson/bupropion se ne sme uporabljati med obdobjem dojenja.
English: More pronounced weight loss was observed in the cohort of subjects who completed 56 weeks of treatment with naltrexone / bupropion (-8.1%) compared to placebo (-1.8%).
Slovenian: Zmanjšanje telesne mase v kohorti preiskovancev, ki so zaključili 56-tedensko zdravljenje z naltreksonom/bupropionom (-8,1 %), je bilo izrazitejše kot v skupini, ki je prejemala placebo (-1,8 %).
English: Fasting insulin, % change
Slovenian: Insulin na tešče,
English: Naltrexone / bupropion has influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Kombinacija naltrekson/bupropion ima vpliv na sposobnost vožnje in upravljanja strojev.
English: • you have any liver problems before you start Mysimba.
Slovenian: • če imate težave z jetri, preden začnete jemati zdravilo Mysimba;
English: • Patients with a current seizure disorder or a history of seizures (see section 4.4)
Slovenian: • Bolniki, ki imajo trenutno konvulzivne motnje ali so imeli v preteklosti epileptične napade (glejte poglavje 4.4)
English: Uncommon Sputum increased (N)
Slovenian: Občasni povečano nastajanje sputuma (N)
English: The time to resolution of constipation was similar between subjects treated with naltrexone / bupropion and subjects treated with placebo.
Slovenian: Obdobje do izginotja zaprtja je bilo pri preiskovancih, zdravljenih z naltreksonom/bupropionom, podobno kot pri preiskovancih, ki so prejemali placebo.
English: Decreased appetite (N) Uncommon Anorexia (B), Blood glucose disturbances (B)
Slovenian: Občasni anoreksija (B), motnje glukoze v krvi (B)
English: Patients should be advised to notify their prescribing physician if they experience these symptoms.
Slovenian: Če se pri bolnikih pojavijo ti simptomi, jim je treba svetovati, naj o tem obvestijo svojega zdravnika.
English: Studies NB-301, NB-302, and NB-303 were conducted in subjects who were obese, or overweight or obese with comorbidities.
Slovenian: Študije NB-301, NB-302 in NB-303 so bile izvedene z debelimi preiskovanci in s preiskovanci s čezmerno telesno maso oziroma debelimi preiskovanci s soobolenji.
English: At least 14 days should elapse between discontinuation of MAOI and initiation of treatment with naltrexone / bupropion (see section 4.5)
Slovenian: Med prekinitvijo dajanja zaviralcev MAO in uvedbo zdravljenja z naltreksonom/bupropionom mora preteči vsaj 14 dni (glejte poglavje 4.5).
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.
Slovenian: Peroralna uporaba naltreksona pri podganah je povzročila znatno povečanje pogostnosti namišljene brejosti in zmanjšano stopnjo brejosti pri približno 30-kratniku odmerka naltreksona, ki ga vsebuje kombinacija naltrekson/bupropion.
English: (listed in section 6); - if you have an abnormally high blood pressure (hypertension) that is not controlled using a medicinal product;
Slovenian: - če ste alergični na naltrekson, bupropion ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate nenormalno visok krvni tlak (hipertenzijo), ki ni nadzorovan z zdravilom;
English: Elderly patients may be more sensitive to the central nervous system adverse reactions of naltrexone / bupropion.
Slovenian: Starejši bolniki so morda bolj občutljivi za neželene učinke naltreksona/bupropiona na centralni živčni sistem.
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).
Slovenian: Povprečna sprememba za HbA1c glede na izhodiščno vrednost v 56. tednu je znašala -0,63 % pri preiskovancih, zdravljenih z naltreksonom/bupropionom, v primerjavi z vrednostjo -0,14 % (p<0,001) pri preiskovancih, ki so prejemali placebo.
English: Naltrexone and bupropion are known to be substantially excreted by the kidney, and the risk of adverse reactions to naltrexone / bupropion may be greater in patients with impaired renal function, a condition that is more common in elderly individuals.
Slovenian: Znano je, da se naltrekson in bupropion v glavnem izločata skozi ledvice, tveganje za pojav neželenih učinkov pri naltreksonu/bupropionu pa je verjetno večje pri bolnikih z okvarjeno ledvično funkcijo,
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.
Slovenian: V stanju dinamičnega ravnovesja je hrana vplivala na povečanje AUC in Cmax : vrednost AUC za naltrekson se je povečala 1,7-krat, vrednost Cmax 1,9krat, vrednost AUC za bupropion pa se je povečala 1,1-krat in Cmax 1,3-krat.
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)
Slovenian: • Bolniki s hudo jetrno okvaro (glejte poglavji 4.2 in 5.2)
English: Seizures: The incidence of seizure in naltrexone / bupropion over the course of the clinical program was 0.06% (2/3239 subjects).
Slovenian: Opis izbranih neželenih učinkov Epileptični napadi: Pojavnost epileptičnih napadov pri kombinaciji naltrekson/bupropion v okviru kliničnega programa je znašala 0,06 % (2/3.239 preiskovancev).
English: If serum sickness is suspected, naltrexone / bupropion should be discontinued.
Slovenian: Če obstaja sum na serumsko bolezen, je treba prekiniti jemanje naltreksona/bupropiona.