FrancophonIA/ELRC3.0 huggingface dataset:
English: You should stop taking Mysimba immediately and consult your doctor if you are experiencing any symptoms of an allergic reaction such as swelling of the throat, tongue, lips, or face, difficulty swallowing or breathing, dizziness, fever, rash, pain in the joints or in the muscles, itching or hives after taking this medicine (see also section 4).
Danish: Du bør straks stoppe med at tage Mysimba og kontakte din læge, hvis du får symptomer på en allergisk reaktion såsom hævelse af hals, tunge, læber eller ansigt, synkebesvær eller vejrtrækningsbesvær, svimmelhed, feber, udslæt, smerter i leddene eller i musklerne, kløe eller nældefeber efter indtagelse denne medicin (se også punkt 4).
English: Alternatively, treatment cessation might be considered (see sections 4.7 and
Danish: Alternativt kan behandlingsophør overvejes (se pkt.
English: The results from this study demonstrated that the area under the curve for plasma naltrexone and metabolites and for plasma bupropion and metabolites was increased by less than two-fold in patients with moderate and severe renal impairment, and smaller increases were observed for patients with mild renal impairment.
Danish: Resultaterne fra dette forsøg viste, at området under kurven for plasma naltrexon og metabolitter og for plasma bupropion og metabolitter steg mindre end det dobbelte hos patienter med moderat og svær nyreinsufficiens, og mindre stigninger blev observeret hos patienter med mild nyreinsufficiens.
English: Binding of β-endorphin to mu-opioid receptors on POMC neurons mediates a negative feedback loop on POMC neurons leading to a decrease in the release of α-MSH.
Danish: Binding af β-endorfin til mu-opioid receptorer på POMC-neuroner formidler en negativ feedback-loop på POMC-neuroner, der fører til et fald i frigivelsen af α-MSH.
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.
Danish: Patienter med type 2-diabetes i behandling med naltrexon/bupropion viste en højere forekomst af gastrointestinale bivirkninger, primært kvalme, opkastning og diarré, end personer uden diabetes.
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).
Danish: Da monoaminoxidase A- og B-hæmmere også forbedrer de catecholaminerge veje på en anden måde end bupropion, må naltrexon/bupropion ikke anvendes sammen med MAO-hæmmere (se punkt 4.3).
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%.
Danish: I en række undersøgelser med raske frivillige nedsatte ritonavir (100 mg to gange daglig eller 600 mg to gange dagligt) eller ritonavir 100 mg plus lopinavir 400 mg to gange dagligt eksponeringen af bupropion og dets vigtigste metabolitter på en dosisafhængig måde med 20 til 80 %.
English: Indigo Carmine Aluminium Lake (E132) 6.2 Incompatibilities Not applicable.
Danish: Indigocarmin, aluminium lake (E132) 6.2 Uforligeligheder
English: There were no consistent changes in naltrexone or bupropion metabolites related to varying degrees of hepatic impairment.
Danish: Der var ingen konsistente ændringer i naltrexon eller bupropionmetabolitter relateret til varierende grader af nedsat leverfunktion.
English: Patients with type 2 diabetes may be more prone to these events due to concomitant medicinal product use (e.g., metformin) or may be more likely to have underlying gastrointestinal disorders (e.g., gastroparesis) predisposing to gastrointestinal symptoms.
Danish: Patienter med type 2-diabetes kan være mere udsatte for disse tilfælde på grund af samtidigt lægemiddelbrug (fx. metformin) eller kan være mere udsatte for underliggende gastrointestinale lidelser (fx. gastroparese), hvilket prædisponerer for gastrointestinale symptomer.
English: Mysimba contains lactose (a type of sugar)
Danish: Mysimba indeholder laktose (et sukkerstof).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/988/001-002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/988/001-002
English: • Medicines used in the treatment of HIV infection and AIDS, such as efavirenz and ritonavir;
Danish: • Lægemidler til behandling af HIV-infektion og AIDS, såsom efavirenz og ritonavir
English: Bupropion is extensively metabolised with three active metabolites: hydroxybupropion, threohydrobupropion and erythrohydrobupropion.
Danish: Bupropion metaboliseres i udstrakt grad med tre aktive metabolitter: hydroxybupropion, threohydrobupropion og erythrohydrobupropion.
English: At least 14 days should elapse between discontinuation of MAOI and initiation of treatment with naltrexone / bupropion (see section 4.5)
Danish: Der skal gå mindst 14 dage mellem seponering af MAOI og igangsættelse af behandling med naltrexon/bupropion (se pkt.
English: However, there is some evidence on hepatotoxicity with increasing dose, since reversible increases of liver enzymes have been found in humans with therapeutic and higher doses (see section 4.4 and 4.8).
Danish: Men der er visse tegn på hepatotoksicitet med stigende dosis, da der er fundet reversibel øgning af leverenzymer hos mennesker med terapeutiske og højere doser (se pkt.
English: As it is unknown whether the risk for seizure with bupropion is related to bupropion or a metabolite of bupropion, and there are no data demonstrating comparability of plasma concentrations with repeated dosing, there is uncertainty whether repeated-dose administration naltrexone / bupropion may be associated with a similar rate of seizures as bupropion SR 300 mg.
Danish: Da det er uvist, om risikoen for krampeanfald med bupropion er relateret til bupropion eller en metabolit af bupropion, og der ikke er data, der viser sammenlignelige plasmakoncentrationer med gentagen dosering, er der usikkerhed om, hvorvidt gentagen dosisadministration af naltrexon/bupropion kan være forbundet med en tilsvarende risiko for anfald som bupropion depot 300 mg.
English: Data summaries for mean change in body weight reflect the Intent-to-Treat (ITT) population, defined as subjects who were randomized, had a baseline body weight measurement, and had at least one post-baseline body weight measurement during the defined treatment phase, using a last observation carried forward (LOCF)
Danish: Data-resuméer for gennemsnitlig ændring i kropsvægt afspejler Intent-to-Treat (ITT) population, defineret som forsøgspersoner, der blev randomiseret, havde en baseline kropsvægtsmåling og havde mindst én kropsvægtsmåling efter baseline i den definerede behandlingsfase, ved hjælp af en ‘last observation carried forward' (LOCF) analyse, samt en completers analyse.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/988/001 112 tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/988/001 112 tabletter
English: Do not take Mysimba: - if you are allergic to naltrexone, to bupropion or to any of the other ingredients of this medicine
Danish: Tag ikke Mysimba: - hvis du er allergisk over for naltrexon, bupropion eller et af de øvrige indholdsstoffer i Mysimba (angivet i punkt 6).
English: Uncommon Ataxia (B), Incoordination (B)
Danish: Ataksi (B), manglende koordination (B)
English: The clinical consequences of the inhibition of the metabolism of bupropion via CYP2B6 enzyme and the consequent changes in the bupropion-hydroxybupropion ratio are currently unknown, but could potentially lead to reduced efficacy of naltrexone / bupropion.
Danish: De kliniske konsekvenser af hæmning af metaboliseringen af bupropion via CYP2B6-enzymet og de deraf følgende ændringer i bupropion-hydroxybupropionforholdet er i øjeblikket ukendt, men kan potentielt medføre reduceret virkning af naltrexon/bupropion.
English: However, approximately 12% of subjects took a concomitant opioid or opioid-like medicinal product while enrolled in the naltrexone / bupropion clinical studies, the majority of whom continued study treatment without interruption of naltrexone / bupropion dose, without untoward consequences.
Danish: Omtrent 12 % af patienterne tog dog et samtidigt opioid eller opioid-lignende lægemiddel, mens de var indskrevet i de kliniske undersøgelser med naltrexon/bupropion, hvoraf de fleste fortsatte undersøgelsesbehandling uden afbrydelse af naltrexon/bupropion-dosis uden uheldige konsekvenser.
English: No effect on fertility in reproductive toxicity studies have been observed with bupropion.
Danish: Der er ikke observeret effekt på fertiliteten i undersøgelser om reproduktionstoksicitet med bupropion.
English: Naltrexone / bupropion should not be used during pregnancy or in women currently attempting to become pregnant.
Danish: Naltrexon/bupropion bør ikke anvendes under graviditet eller til kvinder, der prøver at blive gravide.
English: Acute ingestion of doses in excess of 10 times the maximum therapeutic dose of bupropion (equivalent to approximately in excess of 8 times the recommended daily dose of naltrexone / bupropion) has been reported.
Danish: Der er rapporteret om akut indtagelse af doser på mere end 10 gange den maksimale terapeutiske dosis af bupropion (svarende til mere end ca. 8 gange den anbefalede daglige dosis af naltrexon/bupropion).
English: Biotransformation and elimination:
Danish: Metabolisering og elimination:
English: Administration of naltrexone / bupropion to patients receiving either levodopa or amantadine concurrently should be undertaken with caution.
Danish: Administration af naltrexon/bupropion til patienter, der får enten levodopa eller amantadin samtidigt, bør ske med forsigtighed.
English: Among the group of subjects treated with naltrexone / bupropion, both cases of seizures were considered as serious and led to treatment discontinuation (see section 4.4).
Danish: Blandt gruppen af forsøgspersoner, der blev behandlet med naltrexon/bupropion, blev begge tilfælde af anfald betragtet som alvorlige og førte til seponering af behandlingen (se pkt.
English: Due to the dose-related risk of seizures with bupropion, hospitalisation following suspected overdose with naltrexone / bupropion should be considered.
Danish: På grund af den dosisrelaterede risiko for anfald med bupropion, så bør hospitalsindlæggelse overvejes ved mistanke om overdosering med naltrexon/bupropion.
English: In clinical practice with other bupropion containing products, hypertension, in some cases severe and requiring acute treatment, has been reported.
Danish: Der er i klinisk praksis med andre bupropion-holdige produkter blevet rapporteret om forhøjet blodtryk, i nogle tilfælde alvorlige, der kræver akut behandling.
English: The results from this study demonstrated that in patients with mild hepatic impairment (Child-Pugh scores of 5-6 [Class A]), there was a modest increase in naltrexone concentrations, but concentrations of bupropion and most other metabolites were mostly comparable and no more than doubled to those in patients with normal hepatic function.
Danish: Resultaterne fra dette studie påviste, at der hos patienter med let nedsat leverfunktion (Child-Pugh-scorer på 5-6 [klasse A]) var en beskeden stigning i naltrexonkoncentrationer, men koncentrationer af bupropion og de fleste andre metabolitter var hovedsageligt sammenlignelige og blev ikke mere end fordoblet i forhold til koncentrationer hos patienter med normal leverfunktion.
English: Although most subjects recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in subjects ingesting large doses of the drug.
Danish: Selv om de fleste forsøgspersoner kom sig uden følgevirkninger, så er der rapporteret om dødsfald i forbindelse med overdoser af udelukkende bupropion hos forsøgspersoner, der indtog store doser af lægemidlet.
English: Mechanism of action and pharmacodynamic effects The exact neurochemical appetite suppressant effects of naltrexone / bupropion are not fully understood.
Danish: Virkningsmekanisme og farmakodynamisk virkning Der er endnu ikke fuld forståelse af de nøjagtige neurokemiske appetitundertrykkende virkninger af naltrexon/bupropion.
English: Full analysis set+
Danish: Completers analysesæt++
English: • Patients with uncontrolled hypertension (see section 4.4)
Danish: • Patienter med ukontrolleret hypertension (se pkt.
English: Seizures: The incidence of seizure in naltrexone / bupropion over the course of the clinical program was 0.06% (2/3239 subjects).
Danish: Krampeanfald: Forekomsten af anfald i naltrexon/bupropion i løbet af det kliniske program var 0,06 % (2/3239 forsøgspersoner).
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.
Danish: Patienter med moderat nedsat nyrefunktion havde en højere forekomst af gastrointestinale og centralnervesystemsrelaterede bivirkninger, disse patienter havde således generelt lavere tolerabilitet af naltrexon/bupropion ved en samlet daglig dosis på 32 mg naltrexonhydrochlorid/360 mg bupropionhydrochlorid, som menes at skyldes højere plasmakoncentrationer af aktive metabolitter.
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.
Danish: Da naltrexons og bupropions metaboliske produkter udskilles i urinen og ældre mennesker er mere tilbøjelige til at have nedsat nyrefunktion, bør man tage hensyn til dette ved valg af dosis, og det kan være nyttigt at overvåge nyrefunktionen.
English: The DEXA assessment showed that treatment with naltrexone / bupropion was associated with greater reductions from baseline in total body fat and in visceral adipose tissue than placebo.
Danish: DEXA-vurderingen viste, at behandling med naltrexon/bupropion var forbundet med større reduktioner fra baseline i total kropsfedt og i visceralt fedtvæv end placebo.
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.
Danish: Undersøgelser NB-301, NB-303 og NB-304 indeholdt periodisk vejledning fra undersøgelsesstederne om at reducere kalorieindtag og øge den fysiske aktivitet, mens NB-302 indeholdt et intensivt adfærdsændringsprogram bestående af 28 grupperådgivningssessioner i løbet af 56 uger, samt en fastsat streng diæt og motionsforløb.
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%.
Danish: Bupropion er forbundet med en dosis-relateret risiko for krampeanfald, hvor bupropion depot 300 mg giver en anslået forekomst af krampeanfald på 0,1 %.
English: There are no or limited amounts of data from the use of naltrexone / bupropion in pregnant women.
Danish: Der foreligger ingen eller ikke tilstrækkelige data for brug af naltrexon/bupropion til gravide kvinder.
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.
Danish: Efter et år var det gennemsnitlige vægttab (ved hjælp af LOCF-metoden) blandt disse Uge 16 Respondenter, der fik naltrexon/bupropion, 11,3 %, med 55 %, der havde tabt ≥10 % kropsvægt.
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.
Danish: Ved steady state resulterede madeffekten i AUC- og Cmax-stigninger på hhv. 1,7- og 1,9-fold for naltrexon, og hhv. 1,1- og 1.3-fold for bupropion.
English: Chest pain, Peripheral coldness, Pyrexia
Danish: Brystsmerter, perifer kulde, pyreksi
English: There is limited experience with overdose of naltrexone monotherapy in humans.
Danish: Der er begrænset erfaring med overdosering af naltrexon-monoterapi hos mennesker.
English: Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses.
Danish: Der er rapporteret om feber, muskelstivhed, rhabdomyolyse, hypotension, stupor, koma og respirationsinsufficiens, hovedsagelig når bupropion var en del af flere overdoser.
English: The initial dose is usually one tablet (8 mg naltrexone hydrochloride / 90 mg bupropion hydrochloride) once a day in the morning.
Danish: Startdosis er normalt én tablet (8 mg naltrexon / 90 mg bupropion-hydrochlorid) én gang dagligt om morgenen.
English: • Medicines used to treat epilepsy such as valproate, carbamazepine, phenytoin or phenobarbital.
Danish: • Lægemidler til behandling af epilepsi, såsom valproat, carbamazepin, phenytoin eller phenobarbital.
English: Patients should be aware that they may be more sensitive to lower doses of opioids after naltrexone / bupropion treatment is discontinued.
Danish: Patienter skal være opmærksomme på, at de kan være mere følsomme over for lavere doser af opioider efter behandling med naltrexon/bupropion seponeres.
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.
Danish: Begrænsede kliniske data tyder på en højere forekomst af bivirkninger (fx. kvalme, opkastning og neuropsykiatriske bivirkninger - se pkt 4.8) hos patienter, der får bupropion samtidigt med enten levodopa eller amantadin.
English: Caution should be used when prescribing naltrexone / bupropion to patients with predisposing factors that may increase the risk of seizure including:
Danish: Der bør udvises forsigtighed ved ordination af naltrexon/bupropion til patienter med prædisponerende faktorer, der kan øge risikoen for krampeanfald herunder:
English: • Some medicines used to treat high blood pressure (beta-blockers such as metoprolol, and clonidine, a centrally acting antihypertensive);
Danish: • Nogle lægemidler til behandling af forhøjet blodtryk (betablokkere, såsom metoprolol, og clonidin, et centralt virkende antihypertensiv)
English: Mysimba should not be used during pregnancy, or while breast-feeding.
Danish: Mysimba bør ikke anvendes under graviditet eller amning.
English: Hot flush, Hypertension, Blood pressure increased
Danish: Almindelig Hedetur, hypertension, forhøjet blodtryk Ikke kendt
English: There is no experience with the use of forced diuresis, dialysis, hemoperfusion, or exchange transfusion in the management of combined use of bupropion and naltrexone overdoses.
Danish: Der er ingen erfaring med brug af forceret diurese, dialyse, hæmoperfusion eller udskiftningstransfusion i håndteringen af overdoser med kombineret anvendelse af bupropion og naltrexon.
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.
Danish: Der blev udført fire multicenter, dobbelte placebo-kontrollerede svær overvægt fase 3 undersøgelser (NB-301, NB-302, NB-303 og NB-304) for at vurdere virkningen af naltrexon/bupropion sammenholdt med livsstilsændringer hos 4.536 forsøgspersoner randomiseret til naltrexon/bupropion eller placebo.
English: Although in placebo-controlled clinical trials with naltrexone / bupropion for the treatment of obesity in adult subjects, no suicides or suicide attempts were reported in studies up to 56 weeks duration with naltrexone / bupropion, suicidality events (including suicidal ideation) have been reported in subjects of all ages treated with naltrexone / bupropion post-marketing.
Danish: Selv om der i placebo-kontrollerede kliniske forsøg med naltrexon/bupropion til behandling af svær overvægt hos voksne forsøgspersoner ikke blev rapporteret om selvmord eller selvmordsforsøg i studier af op til 56 ugers varighed med naltrexon/bupropion, der blev rapporteret selvmordshændelser (herunder selvmordstanker) hos patienter i alle aldre, der blev behandlet med naltrexon/bupropion efter markedsføring.
English: Attempt to overcome blockade: The attempt to overcome any naltrexone opioid blockade by administering large amounts of exogenous opioids is very dangerous and may lead to a fatal overdose or life endangering opioid intoxication (e.g., respiratory arrest, circulatory collapse).
Danish: Forsøget på at overvinde naltrexon-opioid-blokade ved administration af store mængder af exogene opioider er meget farligt og kan føre til en dødelig overdosis eller livstruende opioid-forgiftning (fx. åndedrætsstop, kredsløbskollaps).
English: The most common type of seizures is generalised tonic-clonic seizures, a seizure type which can result in some cases in post-ictal confusion or memory impairment (see section 4.4).
Danish: Den mest almindelige form for krampeanfald er generaliserede toniske-kloniske anfald, en anfaldstype, som nogle gange kan resultere i postikal forvirring eller hukommelsessvækkelse (se pkt.
English: The MAH shall ensure that in each Member State where Mysimba is marketed, all healthcare professionals who are expected to prescribe Mysimba are provided with a prescriber guide.
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale, som forventes at ordinere Mysimba i hver enkelt medlemsstat, hvor Mysimba markedsføres, er forsynet med en ordinerende lægevejledning.
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.
Danish: Naltrexon og bupropion er kendt for at blive udskilt af nyrerne i væsentlig grad og risikoen for bivirkninger af naltrexon/bupropion kan være større hos patienter med nedsat nyrefunktion, en tilstand, der er mere normal hos ældre personer.
English: Uncommon Sputum increased (N)
Danish: Forøget sputum (N)
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.
Danish: En patient bør stoppe med at tage naltrexon/bupropion og konsultere en læge, hvis der sker allergiske eller anafylaktoide/anafylaktiske reaktioner (fx. hududslæt, kløe, nældefeber, brystsmerter, ødem, og åndenød) under behandlingen.
English: Accumulation:
Danish: Akkumulering:
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).
Danish: Hos en undergruppe af forsøgspersoner blev kropssammensætning målt ved anvendelse af dual energy X-ray absorptiometry (DEXA) (naltrexon/bupropion = 79 forsøgspersoner og placebo = 45 forsøgspersoner) og multislice computertomografi (CT) scanning (naltrexon/bupropion = 34 forsøgspersoner og placebo = 24 forsøgspersoner).
English: Although not metabolised by the CYP2D6 isoenzyme, bupropion and its main metabolite, hydroxybupropion, inhibit the CYP2D6 pathway and the potential exists to affect medicinal products metabolised by CYP2D6.
Danish: Selv om det ikke metaboliseres af CYP2D6 isoenzym, så hæmmer bupropion og dets hovedmetabolit, hydroxybupropion, CYP2D6 pathway og potentiale for at påvirke lægemidler, som metaboliseres af CYP2D6.