FrancophonIA/ELRC3.0 huggingface dataset:
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).
Danish: I betragtning af den langvarige karakter af lægemiddelfrigivelse for naltrexon/bupropion blev Cmax for naltrexon dog markant reduceret i forhold til 50 mg naltrexonhydrochlorid tablet med øjeblikkelig frigivelse administreret alene (ca. 2-fold forskel efter dosisjustering).
English: NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets
Danish: LÆGEMIDLETS NAVN Mysimba 8 mg/90 mg depottabletter
English: Effect on cardiovascular and metabolic parameters Improvements were observed for waist circumference (including subjects with type 2 diabetes), triglycerides, HDL-C and LDL-C/HDL-C ratio for subjects treated with naltrexone / bupropion vs. placebo in all Phase 3 studies (Table 5).
Danish: Virkning på kardiovaskulære og metaboliske parametre Der blev observeret forbedringer for taljemål (herunder forsøgspersoner med type 2-diabetes), triglycerider, HDL-C og LDL-C/HDL-C-forhold for forsøgspersoner, der blev behandlet med naltrexon/bupropion vs. placebo i alle fase 3-undersøgelser (tabel 5).
English: HOMA-IR, % change + Based on LOCF with the last on-drug observation carried forward.
Danish: + Baseret på LOCF med ‘last on-drug observation carried forward'.
English: Studies NB-301, NB-302, and NB-303 were conducted in subjects who were obese, or overweight or obese with comorbidities.
Danish: Undersøgelser NB-301, NB-302 og NB-303 blev udført hos forsøgspersoner, som var svært overvægtige eller overvægtige eller overvægtige med co-morbiditeter.
English: Excipient with known effect: Each prolonged-release tablet contains 73.2 mg of lactose (see section 4.4).
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver depottablet indeholder 73,2 mg laktose (se pkt.
English: • Some medicines used to treat cancer (such as cyclophospamide, ifosphamide, tamoxifen);
Danish: • Nogle lægemidler til behandling af kræft (fx. cyclofospamid, ifosfamid, tamoxifen)
English: Arthralgia, myalgia and fever have also been reported in association with rash and other symptoms suggestive of delayed hypersensitivity.
Danish: Artralgi, myalgi og feber er også blevet rapporteret i forbindelse med udslæt og andre symptomer, der tyder på forsinket overfølsomhed.
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%).
Danish: Der blev observeret et mere udtalt vægttab i kohorten af forsøgspersoner, der afsluttede 56 uger af behandlingen med naltrexon/bupropion (-8,1 %) sammenlignet med placebo (-1,8%).
English: Improvements were observed for fasting glucose, fasting insulin, HOMA-IR and percent of subjects requiring rescue diabetes medicinal products for subjects treated with naltrexone / bupropion vs. placebo.
Danish: Der blev observeret forbedringer for fastende glukose, fastende insulin, HOMA-IR og procent af forsøgspersoner, der krævede undsættende diabetes-lægemidler hos forsøgspersoner behandlet med naltrexon/bupropion vs. placebo.
English: Eye irritation, Eye pain or asthenopia, Eye swelling, Lacrimation increased, Photophobia, Vision blurred
Danish: Øjenirritation, øjensmerter eller astenopi, hævede øjne, øget tåreflåd, fotofobi, sløret syn
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.
Danish: Plasmakoncentrationerne af bupropion og metabolitter af bupropion efter en enkelt administration af 180 mg bupropion som naltrexon/bupropion-tabletter er sammenlignelig med koncentrationerne, der observeres efter en enkelt administration af bupropion depot 150 mg. Der er dog ikke foretaget nogen undersøgelse, der fastslår koncentrationerne af bupropion og metabolitter af bupropion efter gentagen dosering af naltrexon/bupropion-tabletter sammenlignet med bupropion depottabletter.
English: PHARMACEUTICAL FORM AND CONTENTS 28 prolonged-release tablets 112 prolonged-release tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 28 depottabletter
English: Mysimba is approved for use in patients with an initial body mass index of 30 or greater; it can also be given to those with a body mass index between 27 and 30 if they have additional weight-related conditions such as controlled high blood pressure (hypertension), type 2 diabetes or high levels of lipid (fat) in the blood.
Danish: Det kan også gives til dem med et BMI på mellem 27 og 30, hvis de har yderligere vægt-relaterede sygdomme som kontrolleret forhøjet blodtryk (hypertension), type 2-diabetes eller højt lipid (fedt) i blodet.
English: As expected, naltrexone / bupropion -treated subjects had a greater mean increase from baseline compared with placebo-treated subjects in percent of total body lean mass.
Danish: Som forventet havde naltrexon/bupropion-behandlede forsøgspersoner en større gennemsnitlig stigning fra baseline sammenlignet med placebo-behandlede forsøgspersoner i procent af kroppens samlede fedtfri masse.
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.
Danish: Mysimba depottabletter er blå, bikonvekse, runde tabletter præget med “NB-890” på den ene side.
English: NB-303 NB PBO NB PBO NB PBO NB PBO Randomized Population+ N ≥5% Weight Loss
Danish: NB-303 NB PBO NB PBO NB PBO NB PBO Randomiseret population+ N
English: No events of dizziness, dry mouth, headache, or insomnia in subjects treated with naltrexone / bupropion were considered serious.
Danish: Der var ingen tilfælde af svimmelhed, mundtørhed, hovedpine eller søvnløshed hos forsøgspersoner behandlet med naltrexonbupropion, der blev betragtet som alvorlige.
English: Naltrexone / bupropion should be discontinued and not restarted in patients who experience a seizure while being treated with the medicinal product.
Danish: Naltrexon/bupropion skal afbrydes og ikke genoptages hos patienter, som får et krampeanfald under behandling med lægemidlet.
English: • Some medicines used to treat irregular heart rhythm (such as propafenone, flecainide);
Danish: • Nogle lægemidler til behandling af uregelmæssig hjerterytme (fx. propafenon, flecainid)
English: Patients should be cautioned about driving or operating hazardous machinery in case naltrexone/bupropion may affect their ability to engage in such activities (see sections 4.4 and 4.8)
Danish: Patienterne bør advares mod at føre motorkøretøj eller betjene farligt maskineri, i tilfælde af at naltrexon/bupropion påvirker deres evne til at deltage i sådanne aktiviteter (se pkt.
English: The bupropion Cmax from naltrexone / bupropion (180 mg bupropion hydrochloride) was equivalent to the Cmax of bupropion PR (150 mg bupropion hydrochloride), indicating that the bupropion Cmax achieved with naltrexone / bupropion (360 mg bupropion hydrochloride /day) is comparable to that achieved with commercially available bupropion PR (300 mg bupropion hydrochloride /day) administered alone.
Danish: bupropion Cmax fra naltrexon/bupropion (180 mg bupropion-hydrochlorid) var svarende til Cmax for bupropion depot (150 mg bupropion-hydrochlorid), hvilket indikerer, at bupropion Cmax opnået med naltrexon/bupropion (360 mg bupropion-hydrochlorid/dag) er sammenlignelig med hvad der opnås med kommercielt tilgængeligt bupropion depot (300 mg bupropion-hydrochlorid/dag) administreret alene.
English: • ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight (see Section 5.1).
Danish: (fx. type 2 diabetes, dyslipidæmi, eller kontrolleret hypertension) Behandling med Mysimba bør afbrydes efter 16 uger, hvis patienterne ikke har tabt mindst 5 % af deres oprindelige kropsvægt (se pkt.
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.
Danish: Da bupropion metaboliseres i stor udstrækning, så tilrådes der forsigtighed, når naltrexon/bupropion co-administreres med lægemidler, der er kendt for at inducere CYP2B6 (fx. carbamazepin, phenytoin, ritonavir, efavirenz), da disse kan påvirke den kliniske effekt af naltrexon/bupropion.
English: Effects on glycaemic control in obese subjects with type 2 diabetes After 56 weeks of treatment in subjects with type 2 diabetes (NB-304), naltrexone / bupropion exhibited improvements in glycaemic control parameters compared to placebo (Table 5).
Danish: Virkning på glykæmisk kontrol hos svært overvægtige patienter med type 2-diabetes Efter 56 ugers behandling hos forsøgspersoner med type 2-diabetes (NB-304), udviste naltrexon/bupropion forbedringer i parametre for blodsukkerregulering sammenlignet med placebo (tabel 5).
English: Fatigue, Feeling jittery, Irritability Uncommon Asthenia, Feeling abnormal, Feeling hot, Increased appetite, Thirst
Danish: Asteni, følelse af unormalitet, varmefølelse, øget appetit, tørst
English: Adverse reactions reported in subjects who received Naltrexone/Bupropion as a fixed-dose combination
Danish: Bivirkninger rapporteret hos forsøgspersoner, der fik naltrexon/bupropion som fast-dosis-kombination Systemorganklasse
English: • you have any kidney problems before you start Mysimba.
Danish: • du har nogen form for nyreproblemer, før du starter med Mysimba.
English: Diarrhoea, Flatulence, Haemorrhoids , Ulcer
Danish: Diarré, flatulens, hæmorider, mavesår
English: Following single oral administration of naltrexone / bupropion tablets to healthy subjects, peak concentrations of naltrexone and bupropion occurred approximately 2 and 3 hours post administration of naltrexone / bupropion, respectively.
Danish: Efter enkelt oral administration af naltrexon/bupropion-tabletter til raske forsøgspersoner forekom peak-koncentrationer af naltrexon og bupropion henholdsvis ca. 2 og 3 timer efter administration af naltrexon/bupropion.
English: There are no data on fertility from the combined use of naltrexone and bupropion.
Danish: Der er ingen data om fertilitet fra den kombinerede brug af naltrexon og bupropion.
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).
Danish: Der blev oftere observeret vægttab på mindst 5 % baseline kropsvægt hos forsøgspersoner, der blev behandlet med naltrexon/bupropion (31 %) sammenlignet med placebo (12 %) (tabel 3).
English: Cough, Dysphonia, Dyspnoea, Nasal congestion, Nasal discomfort, Oropharyngeal pain, Rhinorrhea, Sinus disorder, Sneezing, Yawning
Danish: Hoste, dysfoni, dyspnø, nasal kongestion, nasalt ubehag, oropharyngeal smerte, næseflåd, bihulelidelse, nysen, gaben
English: Cardiovascular disease
Danish: Hjerte-kar-sygdom
English: Naltrexone / bupropion should be used cautiously in patients with a history of mania.
Danish: Naltrexone/bupropion bør anvendes med forsigtighed til patienter med en anamnese med mani.
English: Following single oral administration of naltrexone / bupropion tablets to healthy subjects, mean T½ elimination half-life was approximately 5 hours for naltrexone and 21 hours for bupropion.
Danish: Efter enkel oral administration af naltrexon/bupropion-tabletter til raske forsøgspersoner var T½ eliminationshalveringstid ca. 5 timer for naltrexon og 21 timer for bupropion.
English: Naltrexone / bupropion should be given with caution to those patients with controlled hypertension and must not be given to patients with uncontrolled hypertension (see section 4.3).
Danish: Naltrexon/bupropion bør gives med forsigtighed til patienter med kontrolleret hypertension og må ikke gives til patienter med ukontrolleret hypertension (se pkt.
English: What Mysimba contains - The active substances are naltrexone hydrochloride and bupropion hydrochloride.
Danish: Mysimba indeholder: - Aktivt stof/aktive stoffer: naltrexonhydrochlorid og bupropionhydrochlorid.
English: The time to resolution of constipation was similar between subjects treated with naltrexone / bupropion and subjects treated with placebo.
Danish: Tiden indtil resolution af forstoppelse var ens mellem forsøgspersoner behandlet med naltrexonbupropion og forsøgspersoner, der blev behandlet med placebo.
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).
Danish: Gennemsnitlig HbA1c-ændring fra baseline ved uge 56 var0,63 % hos forsøgspersoner, der blev behandlet med naltrexon/bupropion sammenlignet med forsøgspersoner, der fik placebo -0,14 % (p <0,001).
English: Similarly, the majority of events of constipation in subjects treated with naltrexone/bupropion were reported during the dose escalation phase.
Danish: Ligeledes blev de fleste af tilfældene af forstoppelse, hos forsøgspersoner behandlet med naltrexonbupropion, rapporteret i den dosiseskalerende fase.
English: It is recommended that patients with moderate or severe renal impairment initiate treatment with one tablet in the morning for the first week of treatment, and escalate to one tablet in the morning and one tablet in the evening from Week 2 onwards.
Danish: Det anbefales, at patienter med moderat eller svær nyreinsufficiens indleder behandling med én tablet om morgenen i første uge af behandlingen og øger dosis til én tablet om morgenen og én tablet om aftenen fra og med uge 2.
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).
Danish: Naltrexon/bupropion er kontraindiceret hos patienter, som får samtidig behandling med monoaminooxidasehæmmere, bupropion eller naltrexon, patienter, som gennemgår akut alkohol- eller benzodiazepinafvænning, patienter der aktuelt er afhængige af kroniske opioider eller opiatagonister (se pkt.
English: If serum sickness is suspected, naltrexone / bupropion should be discontinued.
Danish: Hvis der er mistanke om serumsyge, bør naltrexon/bupropion seponeres.
English: Loss of consciousness, Paraesthesia, Presyncope, Seizure**, Syncope
Danish: Bevidsthedstab, paræstesi, præsynkope, krampeanfald**, synkope
English: Elderly patients may be more sensitive to some of the central nervous system-related adverse reactions of naltrexone / bupropion (primarily dizziness and tremor).
Danish: Ældre patienter kan være mere følsomme over for nogle af bivirkningerne af naltrexon/bupropion (primært svimmelhed og rystelser), der relateres til centralnervesystemet.
English: Naltrexone / bupropion should not be used in children and adolescents.
Danish: Naltrexon/bupropion bør ikke anvendes til børn og unge.
English: It is recommended that patients with mild hepatic impairment initiate treatment with one tablet in the morning for the first week of treatment, and escalate to one tablet in the morning and one tablet in the evening from Week 2 onwards.
Danish: Det anbefales, at patienter med let leverinsufficiens indleder behandling med én tablet om morgenen i den første uge af behandlingen og øger dosis til én tablet om morgenen og én tablet om aftenen fra og med uge 2.
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%).
Danish: Forekomsten af svær kvalme, svær forstoppelse og svær opkastning var lav, men var højere hos forsøgspersoner, der blev behandlet med naltrexonbupropion sammenlignet med forsøgspersoner, der blev behandlet med placebo (svær kvalme: naltrexonbupropion 1,9 %, placebo <0,1 %, svær forstoppelse: naltrexonbupropion 0,6 %, placebo 0,1 %; alvorlig opkastning: naltrexonbupropion 0,7 %, placebo 0,3 %;).
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%).
Danish: Forekomsten af svær hovedpine, svær svimmelhed og svær søvnløshed var lav, men var højere hos forsøgspersoner, der blev behandlet med naltrexonbupropion sammenlignet med forsøgspersoner, der blev behandlet med placebo (svær hovedpine: naltrexonbupropion 1,1%, placebo <0,3 %, svær svimmelhed: naltrexonbupropion 0,6 %, placebo 0,2 %; svær søvnløshed: naltrexonbupropion 0,4 %, placebo 0,1 %;).
English: Uncommon Blood bilirubin increased (N), Jaundice (B)
Danish: Øget bilirubin i blodet (N), gulsot (B)
English: For individuals who are at elevated risk for renal impairment, in particular patients with diabetes or elderly individuals, estimated glomerular filtration rate (eGFR) should be assessed prior to initiating therapy with naltrexone / bupropion.
Danish: For personer, der har forhøjet risiko for nedsat nyrefunktion, især patienter med diabetes eller ældre mennesker, bør den estimerede glomerulære filtrationshastighed (EGFR) vurderes, før behandlingsstart med naltrexon/bupropion.
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).
Danish: Hos patienter, hvor det er nødvendigt med periodisk tilbagevendende opiat-behandling, bør behandlingen med naltrexon/bupropion afbrydes midlertidigt, og opiat-dosis bør ikke øges over standarddosis (se pkt 4.4).
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.
Danish: Som det ses i tabel 2, så havde NB-301 forsøgspersonerne et gennemsnitligt procentvis vægttab på -5,4 %, mens de fik naltrexon/bupropion mod -1,3 % hos placebo-behandlede forsøgspersoner.
English: The effects of cigarette smoking on the pharmacokinetics of bupropion were studied in 34 healthy male and female volunteers; 17 were chronic cigarette smokers and 17 were nonsmokers.
Danish: 17 var kroniske cigaretrygere og 17 var ikke-rygere.
English: Therefore, naltrexone / bupropion should not be used in children and adolescents below 18.
Danish: Derfor bør naltrexon/bupropion ikke anvendes til børn og unge under 18 år.
English: There is no clinical experience with overdose with combined use of bupropion and naltrexone.
Danish: Der er ingen klinisk erfaring med overdosering med kombineret brug af bupropion og naltrexon.
English: The types of tolerability events were similar to the events observed in patients with normal renal function (see sections 4.2, 4.4, and 5.2).
Danish: Typerne af tolerabilitetstilfælde lignede de tilfælde, der blev observeret hos patienter med normal nyrefunktion (se pkt.
English: Approximately half of the subjects treated with naltrexone / bupropion who experienced vomiting first reported the event during the dose escalation phase.
Danish: Ca. halvdelen af forsøgspersonerne, der blev behandlet med naltrexonbupropion og som fik opkastning, rapporterede først tilfældet under den dosiseskalerende fase.
English: Of the subjects with observed data at Week 16 in the four Phase 3 clinical trials, 50.8% of those randomized to receive naltrexone / bupropion had lost ≥5% of their baseline body weight, compared to
Danish: Blandt forsøgspersonerne med observerede data ved uge 16 i de fire fase 3 kliniske forsøg havde 50,8 % af de randomiserede til at modtage naltrexon/bupropion mistet ≥5 % af baseline kropsvægt sammenlignet med 19,3 % af placebo-behandlede forsøgspersoner (uge 16 respondenter).
English: Common events leading to withdrawal among elderly were nausea, vomiting, dizziness, constipation.
Danish: Følgende var fælles for de tilfælde, der førte til seponering bland ældre: kvalme, opkastning, svimmelhed, forstoppelse.
English: Hepatic impairment: A single-dose pharmacokinetic study has been conducted with naltrexone / bupropion in patients with hepatic impairment.
Danish: Leverinsufficiens: Der er blevet gennemført et farmakokinetisk enkeltdosisstudie med naltrexon/bupropion hos patienter med nedsat leverfunktion.
English: Renal impairment: A single-dosepharmacokinetic study has been conducted for naltrexone / bupropion in subjects with mild, moderate, and severe renal impairment, compared with subjects with normal renal function.
Danish: Nyreinsufficiens: Der er blevet gennemført en enkelt-dosis farmakokinetisk undersøgelse for naltrexon/bupropion hos forsøgspersoner med mild, moderat og svær nyreinsufficiens sammenlignet med forsøgspersoner med normal nyrefunktion.
English: Completers++ N
Danish: vægttab vægttab Completers ++ N
English: No specific antidotes for combined use of bupropion and naltrexone are known.
Danish: Der er ingen kendte specifikke antidoter til kombineret brug af bupropion og naltrexon.
English: The most frequent adverse reactions leading to discontinuation with naltrexone / bupropion were nausea, headache, dizziness and vomiting.
Danish: De hyppigste bivirkninger, der medfører seponering af naltrexon/bupropion var kvalme, hovedpine, svimmelhed og opkastning.
English: The most frequent adverse reactions for naltrexone / bupropion are nausea, constipation, vomiting, dizziness, and dry mouth.
Danish: De hyppigste bivirkninger af naltrexon/bupropion er kvalme, forstoppelse, opkastning, svimmelhed og mundtørhed.
English: Arthralgia, Groin pain, Myalgia, Rhabdomyolysis
Danish: Artralgi, lyskesmerter, myalgi, rabdomyolyse
English: Lactose Monohydrate Crospovidone type A Indigo Carmine Aluminium Lake (E132) Hypromellose
Danish: Indigocarmin, aluminium lake (E132) Hypromellose
English: In patients with mild hepatic 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.
Danish: Hos patienter med let nedsat leverfunktion, skal den maksimale anbefalede daglige dosis af naltrexon/bupropion reduceres, da disse patienter kan have højere lægemiddelkoncentrationer, som kan føre til en stigning i bivirkninger (se pkt.
English: There have also been cases of elevated liver enzymes from post-marketing reporting.
Danish: Der har ifølge rapportering efter markedsføringen også være tilfælde med forhøjede leverenzymer.
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.
Danish: For personer, der har forhøjet risiko for nedsat nyrefunktion, især personer med diabetes eller ældre mennesker, bør estimeret glomerulær filtrationshastighed (EGFR) vurderes, før der indledes behandling med naltrexon/bupropion (se pkt.
English: Chills, Energy increased * Cases of suicidal ideation and suicidal behaviour have been reported during NB therapy (see section 4.4).
Danish: * Der er rapporteret tilfælde af selvmordstanker og selvmordsadfærd under behandling med NB (se pkt.