natgillin/translations-raw huggingface dataset:
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).
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).
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.
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.
17 var kroniske cigaretrygere og 17 var ikke-rygere.
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.
Derfor bør naltrexon/bupropion ikke anvendes til børn og unge under 18 år.
Therefore, naltrexone / bupropion should not be used in children and adolescents below 18.
Der er ingen klinisk erfaring med overdosering med kombineret brug af bupropion og naltrexon.
There is no clinical experience with overdose with combined use of bupropion and naltrexone.
Typerne af tolerabilitetstilfælde lignede de tilfælde, der blev observeret hos patienter med normal nyrefunktion (se pkt.
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).
Ca. halvdelen af forsøgspersonerne, der blev behandlet med naltrexonbupropion og som fik opkastning, rapporterede først tilfældet under den dosiseskalerende fase.
Approximately half of the subjects treated with naltrexone / bupropion who experienced vomiting first reported the event during the dose escalation phase.
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).
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
Følgende var fælles for de tilfælde, der førte til seponering bland ældre: kvalme, opkastning, svimmelhed, forstoppelse.
Common events leading to withdrawal among elderly were nausea, vomiting, dizziness, constipation.
Leverinsufficiens: Der er blevet gennemført et farmakokinetisk enkeltdosisstudie med naltrexon/bupropion hos patienter med nedsat leverfunktion.
Hepatic impairment: A single-dose pharmacokinetic study has been conducted with naltrexone / bupropion in patients with hepatic impairment.
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.
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.
vægttab vægttab Completers ++ N
Completers++ N
Der er ingen kendte specifikke antidoter til kombineret brug af bupropion og naltrexon.
No specific antidotes for combined use of bupropion and naltrexone are known.
De hyppigste bivirkninger, der medfører seponering af naltrexon/bupropion var kvalme, hovedpine, svimmelhed og opkastning.
The most frequent adverse reactions leading to discontinuation with naltrexone / bupropion were nausea, headache, dizziness and vomiting.
De hyppigste bivirkninger af naltrexon/bupropion er kvalme, forstoppelse, opkastning, svimmelhed og mundtørhed.
The most frequent adverse reactions for naltrexone / bupropion are nausea, constipation, vomiting, dizziness, and dry mouth.
Artralgi, lyskesmerter, myalgi, rabdomyolyse
Arthralgia, Groin pain, Myalgia, Rhabdomyolysis
Indigocarmin, aluminium lake (E132) Hypromellose
Lactose Monohydrate Crospovidone type A Indigo Carmine Aluminium Lake (E132) Hypromellose
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.
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.
Der har ifølge rapportering efter markedsføringen også være tilfælde med forhøjede leverenzymer.
There have also been cases of elevated liver enzymes from post-marketing reporting.
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.
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.
* Der er rapporteret tilfælde af selvmordstanker og selvmordsadfærd under behandling med NB (se pkt.
Chills, Energy increased * Cases of suicidal ideation and suicidal behaviour have been reported during NB therapy (see section 4.4).
Anoreksi (B), blodglukoseforstyrrelser (B)
Decreased appetite (N) Uncommon Anorexia (B), Blood glucose disturbances (B)
Naltrexon/bupropion er kontraindiceret til patienter, der samtidigt er afhængige af kronisk opioid- eller opiatagonist-terapi (fx. metadon) eller patienter i akut opiat-afvænning (se pkt 4.3).
Naltrexone / bupropion is contraindicated in patients currently dependent on chronic opioid or opiate agonist therapy (e.g., methadone), or patients in acute opiate withdrawal (see section 4.3).
Mysimba; - hvis du har en bipolar lidelse (ekstreme humørsvingninger); - hvis du bruger anden medicin, som indeholder bupropion eller naltrexon; - hvis du har en spiseforstyrrelse eller havde en tidligere (fx. bulimi eller anoreksi); - hvis du i øjeblikket er afhængig af kroniske opiater eller opiatagonister (fx. metadon), eller du gennemgår en akut afvænning (kold tyrker); - hvis du tager medicin mod depression eller Parkinsons sygdom kaldet monoaminooxidasehæmmere (MAO-hæmmere) eller har taget dem i de sidste 14 dage; - hvis du har alvorlig leversygdom; - hvis du har nyresygdom i terminalfasen.
- if you have a condition that causes fits (seizures) or if you have a history of fits; - if you have a brain tumour; - if you are usually a heavy drinker and you have just stopped drinking alcohol, or are going to stop while you are taking Mysimba; - if you have recently stopped taking sedatives or medicines to treat anxiety (especially benzodiazepines), or if you are going to stop them while you are taking Mysimba; - if you have a bipolar disorder (extreme mood swings); - if you are using any other medicines which contain bupropion or naltrexone; - if you have an eating disorder or had one in the past (for example, bulimia or anorexia nervosa); - if you are currently dependent on chronic opiates or opiate agonists (for example methadone), or you are going through acute withdrawal (cold turkey); - if you are taking medicines for depression or Parkinson's disease called monoamine oxidase inhibitors (MAOIs) or have taken them in the last 14 days; - if you have severe liver disease; - if you have endstage kidney disease.
Det skal du vide, før du begynder at tage Mysimba
What you need to know before you take Mysimba
Blod og lymfesystem
Blood and Lymphatic System Disorders Rare
Kontakt din læge med det samme, hvis du bemærker nogen af følgende alvorlige bivirkninger: - Selvmordstanker og følelse af at være deprimeret Hyppigheden af bivirkningerne selvmordsforsøg, selvmordsadfærd, selvmordstanker og følelse af at være deprimeret er ikke kendt og kan ikke estimeres ud fra de forhåndenværende data fra personer, der tager Mysimba.
Frequency of the side effects suicide attempts, suicidal behavior, suicidal thoughts and feeling depressed are not known and cannot be estimated from the available data in people taking Mysimba.
Det anbefales ikke at fremkalde opkastning.
Induction of emesis is not recommended.
Behandlingen med naltrexon/bupropion bør følges med tæt overvågning af patienterne, navnlig dem med høj risiko - især tidligt i behandlingen og efter dosisændringer.
Close supervision of patients, particularly those at high risk, should accompany therapy with naltrexone / bupropion especially in early treatment and following dose changes.
Virkning på evnen til at føre motorkøretøj og betjene maskiner Brugen af naltrexon/bupropion har været forbundet med døsighed og episoder med bevidsthedstab, sommetider forårsaget af krampeanfald.
The use of naltrexone/bupropion has been associated with somnolence and episodes of loss of consciousness, sometimes caused by seizure.
kardiovaskulære udfald (cardiovascular outcomes tria, CVOT), var ikke højere end antallet af krampeanfald med bupropion som enkeltstof i godkendte doser.
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.
Hos patienter med let leverinsufficiens, er den maksimale anbefalede daglige dosis naltrexon/bupropion to tabletter (én tablet om morgenen og én tablet om aftenen) (se pkt.
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).
De må ikke skæres, tygges eller knuses.
Do not cut them, chew them or crush them.
Ændring i kardiovaskulære og metaboliske parametre fra baseline til uge 56 i fase 3 undersøgelser NB301, NB302 og NB304 og fra baseline til uge 28 i fase 3 undersøgelse NB303
Change in Cardiovascular and Metabolic Parameters from Baseline to Week 56 in Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303
Synsforstyrrelse (B)
Concentration disturbance (B)
Almindelig Palpitationer, forhøjet puls Ikke almindelig
Palpitations, Heart rate increased Uncommon Tachycardia
Anfald (kramper)
Fits (seizures)
Andre hyppige bivirkninger: De fleste forsøgspersoner, der blev behandlet med naltrexonbupropion, rapporterede først om svimmelhed, hovedpine, søvnløshed eller mundtørhed i den dosiseskalerende fase.
Other frequent adverse reactions: The majority of subjects treated with naltrexone / bupropion who reported dizziness, headache, insomnia, or dry mouth, first reported these events during the dose escalation phase.
Indehaveren af markedsføringstilladelsen skal gennemføre og indsende resultaterne af et multicenter, randomiseret, dobbelt-blindt, placebo-kontrolleret, fase 4 undersøgelse, der vurderer effekten af naltrexon (depot) / bupropion (depot) vedr.
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.
Mysimba 8 mg/90 mg depottabletter naltrexon-hydrochlorid/bupropion-hydrochlorid
Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride
++ Forsøgspersoner, der har en baseline og en post-baseline kropsvægtmåling og har gennemført 56 uger (Undersøgelser NB-301, NB-302 og NB-304) eller 28 uger (NB-303) med behandling.
++ Subjects who have a baseline and a post-baseline body weight measurement and completed 56 weeks (Studies NB-301, NB-302, and NB-304) or 28 weeks (NB-303) of treatment.
Bupropion inducerer ikke sin egen metabolisme ved anbefalede doser hos mennesker.
At recommended doses in humans, bupropion does not induce its own metabolism.
LÆGEMIDLETS NAVN Mysimba 8 mg/90 mg depottabletter naltrexon-hydrochlorid/bupropion-hydrochlorid
NAME OF THE MEDICINAL PRODUCT Mysimba 8 mg/90 mg prolonged-release tablets naltrexone hydrochloride / bupropion hydrochloride
Derudover var der reduktion i fastende insulin og HOMA-IR, et mål for insulinresistens, i naltrexon/bupropion-behandlede forsøgspersoner, der ikke har type 2-diabetes.
In addition, in subjects who did not have type 2 diabetes, there were reductions in fasting insulin and HOMA-IR, a measure of insulin resistance, in naltrexone / bupropion-treated subjects.
vægttab vægttab + Med ‘baseline observation carried forward' (BOCF) ++ Forsøgspersoner, der har en baseline og en post-baseline kropsvægtmåling og har gennemført 56 uger (Undersøgelser NB-301, NB-302 og NB-304) eller 28 uger (NB-303) med behandling.
Loss + With baseline observation carried forward (BOCF) ++ Subjects who have a baseline and a post-baseline body weight measurement and completed 56 weeks (Studies NB-301, NB-302, and NB-304) or 28 weeks (NB-303) of treatment.
Hver tablet indeholder 8 mg naltrexon-hydrochlorid, svarende til 7,2 mg naltrexon og 90 mg bupropion-hydrochlorid, hvilket svarer til 78 mg bupropion.
Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2 mg of naltrexone, and 90 mg bupropion hydrochloride, equivalent to 78 mg of bupropion.
Ældre patienter kan være mere følsomme over for bivirkninger af naltrexon/bupropion i centralnervesystemet.
Elderly patients may be more sensitive to the central nervous system adverse reactions of naltrexone / bupropion.
Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release MIAS Pharma Ltd
Hos patienter med let nedsat leverfunktion skal den anbefalede maksimale daglige dosis naltrexon/bupropion reduceres (se pkt.
In patients with mild hepatic impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced (see section 4.2).
Naltrexon/bupropion er kontraindiceret hos patienter med nyresvigt i terminalfasen.
Naltrexone / bupropion is contraindicated in patients with end-stage renal failure.
Unormale drømme, agitation, humørsvingninger, nervøsitet, anspændthed
Uncommon Abnormal dreams, Agitation, Mood swings, Nervousness, Tension, Dissociation (feeling spacey)
• Patienter med en aktuelle krampeanfald eller tidligere krampeanfald (se pkt.
• Patients with a current seizure disorder or a history of seizures (see section 4.4)
Gennemsnitligt vægttab (% ændring) fra baseline til uge 56 i naltrexon/bupropion (NB) fase 3 undersøgelser NB-301, NB-302 og NB-304 og fra baseline til uge 28 i fase 3 undersøgelse NB-303
Mean Weight Loss (% Change) from Baseline to Week 56 in Naltrexone / Bupropion (NB) Phase 3 Studies NB-301, NB-302, and NB-304 and from Baseline to Week 28 in Phase 3 Study NB-303
Lægemidler, der metaboliseres af cytokrom P450- (CYP) enzymer Bupropion metaboliseres primært til dets aktive hovedmetabolit hydroxybupropion af cytochrom P450 CYP2B6.
Drugs metabolised by cytochrome P450 (CYP) enzymes Bupropion is metabolised to its major active metabolite hydroxybupropion primarily by the cytochrome P450 CYP2B6; thus, the potential exists for interaction when administered with medicinal products that induce or inhibit CYP2B6.
Cholecystitis, forhøjet ALAT, forhøjet ASAT, forhøjede leverenzymer
Uncommon Cholecystitis, ALT increased, AST increased, Hepatic enzyme increased
NB PBO NB PBO NB PBO NB PBO Fuldt analysesæt +
NB-303 NB PBO NB PBO NB PBO NB PBO
Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 personer): - Nældefeber (uticaria) - Overfølsomhed - Unormale drømme - Følelse af nervøsitet, følelse af at være excentrisk, anspændthed, ophidselse, humørsvingninger, - Hovedrysten eller rystelser i arme eller ben, der øges, når man forsøger at udføre en bestemt funktion (intention tremor) - Balance-lidelse - Hukommelsestab (amnesi) - Prikken eller følelsesløshed i hænder eller fødder - Transportsyge - Bøvsen - Maveubehag - Fordøjelsesbesvær - Betændelse i galdeblæren (cholecystitis) - Øgede kreatininniveauer i blodet (hvilket indikerer tab af nyrefunktion) - Forhøjede leverenzymer og bilirubin-niveauer, leversygdomme - Vanskeligheder ved at få eller bevare en erektion - Følelse af at være unormal, svaghed (asteni) - Tørst, varmefølelse - Brystsmerter - Øget appetit, vægtøgning
Uncommon side effects (may affect up to 1 in 100 people): - Hives (uticaria) - Hypersensitivity - Abnormal dreams, - Feeling nervous, feeling spacey, tension, agitation, mood swings, Tremor of the head or a limb which increases when trying to perform a particular function (intention tremor) - Balance disorder - Loss of memory (amnesia), Tingling or numbness of the hands or feet - Motion sickness - Burping - Abdominal discomfort - Indigestion - Inflammation of the gallbladder (cholecystitis) - Increased creatinine levels in the blood (indicating loss of kidney function) - Increased liver enzymes and bilirubin levels, liver disorders - Difficulty in getting or keeping an erection - Feeling abnormal, weakness (asthenia) - Thirst, feeling hot - Chest pain - Increased appetite, weight gain
Der må ikke gives naltrexon/bupropion til patienter, der får kronisk opiat-behandling (se pkt.
Naltrexone / bupropion must not be administered to patients receiving chronic opiate therapy (see section 4.3).
Hver tablet indeholder 8 mg naltrexon-hydrochlorid, svarende til 7,2 mg naltrexon og 90 mg bupropionhydrochlorid, hvilket svarer til 78 mg bupropion.
Each tablet contains 8 milligrams of naltrexone hydrochloride, equivalent to 7.2 milligrams of naltrexone, and 90 milligrams of bupropion hydrochloride, equivalent to 78 milligrams of bupropion.
For patienter med moderat eller svær nyreinsufficiens, skal den maksimale anbefalede dosis for naltrexon/bupropion reduceres (se pkt.
For patients with moderate or severe renal impairment, the maximum recommended daily dose for naltrexone / bupropion should be reduced (see section 4.2).
Naltrexon/bupropion bør ikke anvendes under amning.
Naltrexone / bupropion should not be used during breast-feeding.
Idiopatisk trombocytopenisk purpura (N)
Blood and Lymphatic system disorders Uncommon Idiopathic thrombocytopenic purpura (N) Immune system disorders
Naltrexon/bupropion bør anvendes med forsigtighed hos patienter over 65 år og anbefales ikke til patienter over 75 år (se pkt.
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 (see sections 4.4, 4.8 and 5.2).
svær overvægt fase 2 og fase 3 (BMI-område 27-45 kg/m2) med undersøgelser, der varede mellem 16 og 56 uger randomiseret til naltrexonhydrochlorid (16 til 50 mg/dag) og/eller bupropionhydrochlorid (300 til 400 mg/dag) eller placebo.
The effects of naltrexone / bupropion on weight loss, weight maintenance, waist circumference, body composition, obesity-related markers for cardiovascular and metabolic parameters and patient reported assessments were examined in double-blind, placebo-controlled obesity Phase 2 and Phase 3 trials (BMI range 27-45 kg/m2) with study durations of 16 to 56 weeks randomised to naltrexone hydrochloride (16 to 50 mg/day) and/or bupropion hydrochloride (300 to 400 mg/day) or placebo.
(B), libidoforstyrrelse (N), paranoia (B)
Uncommon Delusions (B), Depersonalisation (B), Libido disorder (N), Paranoid ideation (B)
Laktosemonohydrat
Lactose Anhydrous
• Uge 1: Én tablet om morgenen
• Week 1: One tablet in the morning
Nedsat hæmatokrit, Nedsat lymfocyttal
Decreased haematocrit, Lymphocyte count decreased
Hæmatokesi, brok, læbehævelse, smerter i den nedre del af maven, caries***, tandpine
Haematochezia, Hernia, Lip swelling, Lower abdominal pain, Dental caries***, Toothache***
Hydroxypropylcellulose
Cysteine Hydrochloride Microcrystalline Cellulose Hydroxypropyl Cellulose Magnesium Stearate
I undergruppen af forsøgspersoner med mundtørhed blev der observeret en højere forekomst af tandpine og caries hos forsøgspersoner, der behandlet med naltrexonbupropion sammenlignet med forsøgspersoner, der blev behandlet med placebo.
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.
Hos patienter med moderat eller svær nyreinsufficiens er den maksimale anbefalede daglige dosis for naltrexon/bupropion to tabletter (én tablet om morgenen og én tablet om aftenen (se pkt.
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).
Sådan skal du tage Mysimba
How to take Mysimba
Monoaminooxidasehæmmere (MAO-hæmmere)
Monoamine oxidase inhibitors (MAOI)
• Uge 4 og fremefter: To tabletter to gange dagligt, dvs. to tabletter om morgenen og to tabletter om aftenen
• Week 4 and onward: Two tablets twice a day, two in the morning and two in the evening
- Angst - Svimmelhed, følelse af svimmelhed eller “snurren rundt” (vertigo) - Følelse af rystelser (tremor) - Søvnbesvær (tag ikke Mysimba lige inden sengetid) - Ændringer i smagen af mad (smagsforstyrrelser), mundtørhed - Koncentrationsbesvær - Følelse af træthed (energiløshed) og søvnighed, sløvhed eller mangel på energi (letargi) - Ringen for ørerne (tinnitus) - Hurtig eller uregelmæssig hjerterytme - Hedeture - Forhøjet blodtryk (nogle gange alvorligt) - Smerter i den øvre del af maven - Mavesmerter - Øget svedproduktion (hyperhidrosis) - Udslæt, kløe (pruritus) - Hårtab (alopeci) - Irritabilitet - Nervøsitet
- Feeling shaky (tremor) - Difficulty in sleeping (make sure you do not take Mysimba near to bedtime) - Changes in the taste of food (dysgeusia), dry mouth - Difficulty concentrating - Feeling of tiredness (fatigue) and sleepiness, drowsiness or lack of energy (lethargy) - Ringing in the ears (tinnitus) - Fast or irregular heartbeat - Hot flush - Increased blood pressure (sometimes severe) - Pain in the upper part of the abdomen - Pain in the abdomen - Excessive sweating (hyperhidrosis) - Rash, itching (pruritus) - Hair loss (alopecia) - Irritability - Feeling jittery
Undersøgelser med naltrexon i dyr har vist reproduktiv toksicitet (se pkt.
Studies with naltrexone in animals have shown reproductive toxicity (see section 5.3); animal studies with bupropion show no clear evidence of reproductive harm.
• Uge 2: Én tablet om morgenen og én tablet om aftenen
• Week 2: One tablet in the morning and one tablet in the evening