FrancophonIA/ELRC3.0 huggingface dataset:
English: Excessive use of alcohol while being treated with Mysimba might increase the risk for fits (seizures), mental disorder events or might reduce alcohol tolerance.
Danish: Overdreven brug af alkohol under behandling med Mysimba kan øge risikoen for krampeanfald, tilfælde af mental ubalance eller kan nedsætte alkoholtolerance.
English: Clinical studies of naltrexone / bupropion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects.
Danish: Kliniske studier af naltrexon/bupropion omfattede ikke et tilstrækkeligt antal forsøgspersoner i alderen 65 år og derover for at afgøre, om de responderer anderledes end yngre patienter.
English: If you feel depressed, contemplate suicide, have a history of attempting suicide or any other mental health problems, you should inform your doctor before taking this medicine.
Danish: Hvis du føler dig deprimeret, overvejer selvmord, har en historik med at forsøge selvmord eller andre psykiske problemer, skal du informere din læge, før du tager dette lægemiddel.
English: Clinical experience included varying prandial conditions and supports the use of naltrexone / bupropion tablets with food.
Danish: Klinisk erfaring inkluderer varierende prandiale forhold og understøtter brugen af naltrexon/bupropion-tabletter med mad.
English: Administration of naltrexone / bupropion with inhibitors or inducers of UGT 1A2 and 2B7 should be undertaken with caution as these may alter the exposure of naltrexone.
Danish: Administration af naltrexon/bupropion med hæmmere eller inducere af UGT 1A2 og 2B7 bør ske med forsigtighed, da disse kan ændre eksponeringen af naltrexon.
English: Naltrexone / bupropion may be used with caution after chronic opioid use has been stopped for 7 to 10 days in order to prevent precipitation of withdrawal.
Danish: Naltrexon/bupropion kan anvendes med forsigtighed efter at kronisk brug af opioider er blevet stoppet i 7 til 10 dage for at forhindre pludselig udvikling af abstinenser.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Mysimba in one or more subsets of the paediatric population in obesity (see section 4.2 for information on paediatric use).
Danish: Det europæiske lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af studier med Mysimba hos en eller flere undergrupper af den pædiatriske population ved fedme (se pkt.
English: Summaries of the proportion of subjects achieving ≥5% or ≥10% reduction in body weight utilize a baseline observation carried forward (BOCF) analysis of all randomized subjects.
Danish: Resuméer af andelen af forsøgspersoner, der opnåede ≥5 % eller ≥10 % reduktion i kropsvægt, anvender en ‘baseline observation carried forward' (BOCF) analyse af alle randomiserede forsøgspersoner.
English: Although citalopram is not primarily metabolised by CYP2D6, in one study, bupropion increased the Cmax and AUC of citalopram by 30% and 40%, respectively.
Danish: Selvom citalopram ikke primært metaboliseres af CYP2D6, så øgede bupropion Cmax og AUC for citalopram med henholdsvis 30 % og 40 % i en undersøgelse.
English: Changes in mean blood pressure are described in Section 4.4.
Danish: Ændringer i gennemsnitligt blodtryk er beskrevet i pkt.
English: The medicinal product has two components: naltrexone, a mu-opioid antagonist, and bupropion, a weak inhibitor of neuronal dopamine and norepinephrine reuptake.
Danish: Lægemidlet har to komponenter: naltrexon, en mu-opioid antagonist og bupropion, en svag hæmmer af neuronal dopamin og noradrenalin reuptake.
English: Neuropsychiatric symptoms and activation of mania Activation of mania and hypomania have been reported in patients with mood disorders who were treated with other similar medicinal products for major depressive disorder.
Danish: Neuropsykiatriske symptomer og aktivering af mani Der er rapporteret aktivering af mani og hypomani hos patienter med affektive sindslidelser, som blev behandlet med andre lignende lægemidler til svære depressioner.
English: Increases of ~2- and ~4-fold for the area under the curve for bupropion were observed for patients with moderate and severe impairment respectively.
Danish: Stigninger på hhv. ~2 og ~4 gange for arealet under kurven for bupropion blev observeret for patienter med moderat og svært nedsat funktion.
English: Study NB-302 had a more intensive behavioural modification program, while the primary endpoint of Study NB-303 was at Week 28 to allow for re-randomization to different doses in the latter portion of the study.
Danish: Undersøgelse NB-302 havde et mere intensivt adfærdsmodifikationsprogram, mens undersøgelse NB-303s primære endpoint var ved uge 28 for at tillade re-randomisering til forskellige doser i den sidste del af undersøgelsen.
English: When driving vehicles or using machines, it should be taken into account that dizziness, somnolence, loss of consciousness and seizure may occur during treatment.
Danish: Ved bilkørsel eller betjening af maskiner skal der tages hensyn til, at der kan forekomme svimmelhed, døsighed, bevidsthedstab og krampeanfald i forbindelse med behandlingen.
English: + 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.
Danish: + Forsøgspersoner, som var randomiseret, havde en baseline kropsvægtsmåling og havde mindst én post-baseline kropsvægtsmåling i den definerede behandlingsfase.
English: Irregular menstruation, Vaginal haemorrhage, Vulvovaginal dryness
Danish: Uregelmæssig menstruation, vaginal blødning, vulvovaginal tørhed
English: The tablets should not be cut, chewed, or crushed.
Danish: Tabletterne må ikke skæres over, tygges eller knuses.
English: Post Authorisation Safety Study :
Danish: Sikkerhedsundersøgelse efter markedsføringstilladelse:
English: If naltrexone / bupropion is added to the treatment regimen of a patient already receiving a drug metabolised by CYP2D6, the need to decrease the dose of the original medicinal product should be considered, particularly for those concomitant medicinal products with a narrow therapeutic index.
Danish: Hvis der tilsættes naltrexon/bupropion til behandlingsregimet hos en patient, der allerede modtager et lægemiddel, som metaboliseres af CYP2D6, så er det nødvendigt at overveje mindskning af dosis af det oprindelige lægemiddel, især for de samtidige lægemidler med et snævert terapeutisk indeks.
English: * Difference from placebo, p<0.001 ** Difference from placebo, p<0.01
Danish: * Forskel fra placebo, p<0,001 ** Forskel fra placebo, p<0,01
English: 6.4 Special precautions for storage Do not store above 30°C.
Danish: 6.4 Særlige opbevaringsforhold Må ikke opbevares over 30 °C.
English: In the arcuate nucleus of the hypothalamus, bupropion stimulates pro-opiomelanocortin (POMC) neurons that release alpha-melanocyte stimulating hormone (α-MSH), which in turn binds to and stimulates melanocortin 4 receptors (MC4-R).
Danish: I den bueformede kerne i hypothalamus stimulerer bupropion pro-opiomelanocortin (POMC) neuroner, der frigiver alpha-melanocyt-stimulerende hormon (α-MSH), som igen binder til og stimulerer melanocortin 4-receptorer (MC4-R).
English: Naltrexone / bupropion should preferably be taken with food, as it is known that both naltrexone and bupropion plasma concentrations are increased with food and the safety and efficacy data from clinical trials is based on dosing with food.
Danish: Naltrexon/bupropion skal helst tages sammen med mad, da det er kendt, at både naltrexon og bupropion plasmakoncentrationer forhøjes med mad og data om sikkerhed og effekt fra kliniske forsøg er baseret på dosering med mad.
English: The list of terms in Table 2 provides information on the adverse reactions of the individual components naltrexone (N) and bupropion (B) identified in their respective approved SmPCs for different indications.
Danish: Listen over termer i tabel 2 indeholder oplysninger om bivirkningerne af enkeltkomponenterne naltrexon (N) og bupropion (B), der er identificeret i deres respektive godkendte produktresuméer til forskellige indikationer.
English: Naltrexone / bupropion contains bupropion.
Danish: Naltrexon/bupropion indeholder bupropion.
English: • Week 4 and onwards: Two tablets in the morning and two tablets in the evening The maximum recommended daily dose of Mysimba is two tablets taken twice daily for a total dose of 32 mg naltrexone hydrochloride and 360 mg bupropion hydrochloride.
Danish: • Uge 4 og fremefter: To tabletter om morgenen og to tabletter om aftenen Den anbefalede maksimale daglige dosis Mysimba er to tabletter to gange daglig med en total dosis på 32 mg naltrexon-hydrochlorid og 360 mg bupropion-hydrochlorid.
English: Film-coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc and indigo carmine aluminium lake (E132).
Danish: Filmovertræk: polyvinylalkohol, titandioxid (E171), macrogol 3350, talkum og indigo carmine aluminium lake (E132).
English: The mean volume of distribution at steady state of oral naltrexone and bupropion given as naltrexgone / bupropion, Vss/F, was 5697 liters and 880 liters, respectively.
Danish: Den gennemsnitlige fordelingsvolumen ved steady state af oral naltrexon og bupropion, givet som naltrexon/bupropion, Vss/F, var hhv. 5697 liter og 880 liter.
English: Naltrexone and bupropion are well absorbed from the gastrointestinal tract (>90% absorbed), however, naltrexone has a significant first pass effect thereby limiting systemic bioavailablity, with only 5-6% reaching the systemic circulation intact.
Danish: Naltrexon og bupropion absorberes godt fra mavetarmkanalen (> 90 % absorberet), men naltrexon har en betydelig first-pass effekt og begrænser dermed systemisk biotilgængelighed, hvor kun 5-6 % når det systemiske kredsløb intakt.
English: Of the overall population of 4,536 subjects in the naltrexone / bupropion Phase 3 studies, 25% had hypertension, 33% had fasting glucose levels ≥100 mg/dL (5.6 mmol/L) at baseline, 54% had dyslipidaemia at study entry, and 11% had type 2 diabetes.
Danish: Af den samlede population af 4.536 forsøgspersoner i naltrexon/bupropion fase 3-undersøgelsen havde 25 % hypertension, 33 % havde fastende glukose-niveauer på ≥100 mg/dl (5,6 mmol/l) ved baseline, 54 % havde dyslipidæmi ved undersøgelsens start og 11 % havde type 2 diabetes.
English: Following twice daily administration of naltrexone / bupropion, naltrexone does not accumulate, while 6-beta-naltrexol accumulates over time.
Danish: Efter to gange daglig administration af naltrexon/bupropion akkumulerer naltrexon ikke, mens 6-betanaltrexol akkumulerer over tid.
English: Preclinical data suggests that naltrexone and bupropion may have greater than additive effects in this region to reduce food intake when administered together.
Danish: Prækliniske data tyder på, at naltrexon og bupropion kan have mere end blot additiv virkning på at nedsætte fødeindtagelsen i denne region, når det administreres sammen.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Therefore Mysimba should not be used in children and adolescents below 18 years.
Danish: Mysimba bør derfor ikke anvendes til børn og unge under 18 år.
English: Pharmacotherapeutic group: A08AA Centrally acting antiobesity products, ATC code: A08AA62 bupropion and naltrexone.
Danish: Farmakoterapeutisk kategori: A08AA centralt virkende antifedme produkter, ATC-kode: A08AA62 bupropion og naltrexon
English: (e.g., methadone), or patients in acute opiate withdrawal
Danish: metadon) eller patienter i akut opiat-afvænning
English: Use of naltrexone / bupropion with other OCT2 substrates (e.g., metformin) in clinical trials did not indicate the need for dose adjustment or other precautions.
Danish: Anvendelse af naltrexon/bupropion med andre OCT2-substrater (fx. metformin) i kliniske forsøg indikerer ikke behov for dosisjustering eller andre forholdsregler.
English: • steroids (except drops, creams, or lotions for eye and skin conditions or inhalers for breathing disorders such as asthma);
Danish: • steroider (undtagen dråber, cremer eller lotion til øjen- og hudsygdomme eller inhalatorer til vejrtrækningslidelser som astma)
English: MARKETING AUTHORISATION HOLDER Orexigen Therapeutics Ireland Limited 2nd Floor
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Orexigen Therapeutics Ireland Limited 2nd Floor
English: Results are based on last-observation-carriedforward (LOCF).
Danish: ‘last observation carried forward' (LOCF).
English: Česká republika PharmaSwiss Česká republika s.r.o.
Danish: PharmaSwiss Česká republika s.r.o.
English: The treatment should be discontinued if there are concerns with the safety or tolerability of ongoing treatment, including concerns about increased blood pressure (see Section 4.8).
Danish: sikkerhed eller tolerabilitet af igangværende behandling, herunder bekymring for forhøjet blodtryk (se pkt.
English: There is no clinical experience establishing the safety of naltrexone / bupropion in patients with a recent history of myocardial infarction, unstable heart disease or NYHA class III or IV congestive heart failure.
Danish: Der er ingen klinisk erfaring med etablering af sikkerheden for naltrexon/bupropion hos patienter med en nylig anamnese af myokardieinfarkt, ustabil hjertesygdom eller NYHA klasse III eller IV kongestiv hjerteinsufficiens.
English: Blood pressure fluctuation
Danish: Blodtryksudsving
English: Study NB-304 was conducted in subjects who were overweight or obese and had type 2 diabetes mellitus.
Danish: Undersøgelse NB-304 blev gennemført hos forsøgspersoner, der var overvægtige eller svært overvægtige og havde type 2-diabetes mellitus.
English: Elderly people: The pharmacokinetics of naltrexone / bupropion have not been evaluated in the elderly population.
Danish: Ældre personer: Naltrexons/bupropions farmakokinetik er ikke vurderet i den ældre befolkning.
English: The potential exists for a drug interaction between naltrexone / bupropion and drugs that induce or are substrates of the CYP2B6 isozyme.
Danish: Der eksisterer potentiale for en interaktion mellem naltrexon/bupropion og lægemidler, der inducerer eller er substrater af CYP2B6-isozymet.
English: The treatment effects observed in obese and overweight subjects with type 2 diabetes mellitus (Study NB-304) were somewhat less pronounced than those observed in the other Phase 3 studies.
Danish: De observerede behandlingsvirkninger hos svært overvægtige og overvægtige patienter med type 2diabetes mellitus (undersøgelse NB-304) var noget mindre udtalte end dem, der observeres i de andre fase 3-undersøgelser.
English: Naltrexone / bupropion increased metoprolol AUC and Cmax by approximately 4- and 2-fold, respectively, relative to metoprolol alone.
Danish: Naltrexon/bupropion øgede metoprolol AUC og Cmax med henholdsvis ca. 4- og 2- gange i forhold til metoprolol alene.
English: Other major metabolic routes are the formation of the metabolites 2-hydroxy-3-O-methyl naltrexone and 2-hydroxy-3-O-methyl-6-beta-naltrexol, believed to be mediated by catechol-O-methyl transferases (COMT), and glucuronidation, thought to be mediated by UGT1A1 and UGT2B7.
Danish: Andre større metaboliske ruter er dannelsen af metabolitterne 2-hydroxy-3-O-methyl-naltrexon og 2-hydroxy-3-O-methyl-6-beta-naltrexol, hvilket menes at være medieret af catechol-O-methyltransferaser (COMT) og glucuronidering, som menes at være medieret af UGT1A1 og UGT2B7.
English: Breast-feeding Naltrexone and bupropion and their metabolites are excreted in human milk.
Danish: Amning Naltrexon og bupropion og deres metabolitter udskilles i human mælk.
English: Therefore, mild increases in creatinine observed after long-term treatment with naltrexone / bupropion are likely due to inhibition of OCT2 and not indicative of changes in creatinine clearance.
Danish: Milde stigninger i kreatinin efter langtids-behandling med naltrexon/bupropion er derfor sandsynligvis på grund af hæmning af OCT2 og ikke tegn på ændringer i kreatininclearance.
English: Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, sinus tachycardia, and ECG changes such as conduction disturbances (including QRS prolongation) or arrhythmias.
Danish: Andre alvorlige reaktioner med overdoser af kun bupropion omfattede hallucinationer, tab af bevidsthed, sinus takykardi og EKG-forandringer såsom kredsløbsforstyrrelser (herunder QRS-forlængelse) eller arytmier.
English: The effects of combined bupropion and naltrexone use have not been studied in animals.
Danish: Virkningerne af kombineret bupropion og naltrexon brug er ikke undersøgt hos dyr.
English: • concomitant administration of medicinal products that may lower the seizure threshold, including antipsychotics, antidepressants, antimalarials, tramadol, theophylline, systemic steroids, quinolones and sedating antihistamines
Danish: • samtidig administration af lægemidler, der kan nedsætte krampetærsklen, herunder antipsykotika, antidepressiva, malariamidler, tramadol, theophyllin, systemiske steroider, quinoloner og sederende antihistaminer
English: A patient with suspected DILI should stop taking naltrexone / bupropion.
Danish: En patient med formodet DILI bør stoppe med at tage naltrexon/bupropion.
English: Uncommon Exacerbation of psoriasis (B), Seborrhea (N)
Danish: Forværring af psoriasis (B), seborré (N)
English: The risk of seizures is also related to patient factors, clinical situations, and concomitant medicinal products, which must be considered in the selection of patients treated with naltrexone / bupropion.
Danish: Risikoen for anfald er også relateret til patientfaktorer, kliniske situationer og samtidige administreret lægemidler, hvilket skal overvejes i forbindelse med udvælgelsen af patienter, der behandles med naltrexon/bupropion.
English: If patients experience clinically relevant and sustained increases in blood pressure or pulse rate as a result of naltrexone / bupropion treatment, it should be discontinued.
Danish: Hvis patienter oplever klinisk relevante og vedvarende stigninger i blodtryk eller puls som følge af behandling med naltrexon/bupropion, bør det seponeres.
English: The relevance of these observations to human fertility is not known (see section 5.3).
Danish: Relevansen af disse observationer for menneskers fertilitet er ikke kendt (se pkt.
English: A meta-analysis of placebo-controlled clinical trials of antidepressants in adult subjects with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in subjects less than 25 years old.
Danish: En meta-analyse af placebo-kontrollerede kliniske studier af antidepressiva givet til voksne patienter med psykiatriske lidelser viste øget risiko for selvmordsadfærd med antidepressiva sammenlignet med placebo hos patienter, der var under 25 år.
English: *** Toothache and dental caries, while not meeting the criteria for inclusion in this table, are listed based on the subset of patients with dry mouth, in which a higher incidence of toothache and dental caries was observed in subjects treated with NB versus placebo.
Danish: *** Selv om tandpine og caries ikke opfylder kriterierne for optagelse i denne tabel, er disse anført baseret på undergruppen af patienter med mundtørhed, hvor der blev observeret en højere forekomst af tandpine og caries ved behandling med NB versus placebo.
English: Dystonia, Memory impairment, Parkinsonism, Restlessness
Danish: Dystoni, svækket hukommelse, parkinsonisme, rastløshed
English: Liver changes are seen in animal studies with bupropion but these reflect the action of a hepatic enzyme inducer.
Danish: Der er set leverændringer i dyreforsøg med bupropion, men disse afspejler virkningen af en leverenzyminducer.
English: LDL-C/HDL-C ratio
Danish: LDL-C/HDL
English: More severe hypersensitivity reactions including angioedema, dyspnoea/ bronchospasm and anaphylactic shock.
Danish: Mere alvorlige overfølsomhedsreaktioner, herunder angioødem, dyspnø/bronchospasme og anafylaktisk chok.
English: Very common side effects (may affect more than 1 in 10 people): - Feeling sick (nausea), being sick (vomiting) - Constipation - Headache
Danish: Meget almindelige bivirkninger (påvirker mere end 1 ud af 10 personer): - Kvalme eller opkastning - Forstoppelse - Hovedpine
English: If you experience fainting, muscle weakness or fits during treatment, do not drive or use machines.
Danish: Hvis du oplever, at du besvimer, får muskelsvaghed eller krampeanfald under behandling, må du ikke føre motorkøretøj eller betjene maskiner.
English: CYP2B6 inducers, inhibitors and substrates
Danish: CYP2B6-induktorer, -hæmmere og -substrater
English: In vitro findings suggest that CYP2B6 is the principal isozyme involved in the formation of hydroxybupropion, while CYP1A2, 2A6, 2C9, 3A4 and 2E1 are less involved.
Danish: Metabolitterne har længere eliminationshalveringstider end bupropion og akkumulerer i højere grad. In vitro-resultater antyder, at CYP2B6 er den vigtigste isoenzym involveret i dannelsen af hydroxybupropion, mens CYP1A2, 2A6, 2C9, 3A4 og 2E1 er mindre involverede.
English: Mysimba contains 2 active substances: naltrexone hydrochloride and bupropion hydrochloride and is used in obese or overweight adults to manage weight together with a reduced calorie diet and physical exercise.
Danish: Mysimba indeholder 2 aktive stoffer: naltrexon-hydrochlorid og bupropion-hydrochlorid og anvendes hos svært overvægtige eller overvægtige voksne til at håndtere vægt sammen med en kalorienedsat kost og motion.
English: - Erythema multiforme and Stevens Johnson Syndrome Not known - frequency cannot be estimated from the available data in people taking
Danish: - Erythema multiforme og Stevens-Johnsons syndrom Ikke kendt - hyppigheden kan ikke estimeres ud fra de forhåndenværende data hos personer, der tager Mysimba.
English: The additional undesirable effects occurring with either of the individual components (bupropion or naltrexone) when used for non-obesity indications are summarized in Table 2.
Danish: De yderligere bivirkninger, der forekommer med et af stofferne (bupropion eller naltrexon), når de anvendes til indikationer, der ikke er relateret med fedme, er sammenfattet i tabel 2.
English: In clinical studies, 23.8% of subjects receiving naltrexone / bupropion and 11.9% of subjects receiving placebo discontinued treatment due to an adverse event.
Danish: I kliniske undersøgelser afbrød 23,8 % af forsøgspersoner, der fik naltrexon/bupropion og 11,9 % af forsøgspersoner, der fik placebo, behandlingen på grund af en utilsigtet hændelse.
English: Patients must be advised to exercise caution while driving or operating machines during treatment with naltrexone/bupropion, especially at the beginning of the treatment or during the titration phase.
Danish: Patienterne skal rådes til forsigtighed, når de fører motorkøretøj eller betjener maskiner under behandling med naltrexon/bupropion, navnlig i starten af behandlingen eller under titreringsfasen.
English: Reproduction toxicity:
Danish: Reproduktionstoksicitet:
English: See the end of section 4 for how to report side effects.
Danish: Se sidst i punkt 4.8, hvordan du indberetter bivirkninger.
English: The tablets should preferably be taken with food (see section 5.2).
Danish: Tabletterne skal helst tages sammen med mad (se pkt.
English: Naltrexone was also negative in an in vivo mouse micronucleus assay.
Danish: Naltrexon var også negativ i en in vivo musemikronukleustest.
English: Naltrexone / bupropion has not been studied in conjunction with alpha-adrenergic blockers or clonidine.
Danish: Naltrexon/bupropion er ikke undersøgt i forbindelse med alfa-adrenerge blokkere eller clonidin.
English: Bupropion and its metabolites inhibit CYP2D6.
Danish: Bupropion og dets metabolitter hæmmer CYP2D6.
English: There are no known pharmacokinetic interactions between naltrexone and alcohol.
Danish: Der er ingen kendte farmakokinetiske interaktioner mellem naltrexon og alkohol.