natgillin/translations-raw huggingface dataset:
Ved bilkørsel eller betjening af maskiner skal der tages hensyn til, at der kan forekomme svimmelhed, døsighed, bevidsthedstab og krampeanfald i forbindelse med behandlingen. 
When driving vehicles or using machines, it should be taken into account that dizziness, somnolence, loss of consciousness and seizure may occur during treatment.
+ Forsøgspersoner, som var randomiseret, havde en baseline kropsvægtsmåling og havde mindst én post-baseline kropsvægtsmåling i den definerede behandlingsfase. 
+ 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.
Uregelmæssig menstruation, vaginal blødning, vulvovaginal tørhed 
Irregular menstruation, Vaginal haemorrhage, Vulvovaginal dryness
Tabletterne må ikke skæres over, tygges eller knuses. 
The tablets should not be cut, chewed, or crushed.
Sikkerhedsundersøgelse efter markedsføringstilladelse: 
Post Authorisation Safety Study :
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. 
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.
* Forskel fra placebo, p<0,001 ** Forskel fra placebo, p<0,01 
* Difference from placebo, p<0.001 ** Difference from placebo, p<0.01
6.4 Særlige opbevaringsforhold Må ikke opbevares over 30 °C. 
6.4 Special precautions for storage Do not store above 30°C.
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). 
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).
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. 
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.
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. 
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.
Naltrexon/bupropion indeholder bupropion. 
Naltrexone / bupropion contains bupropion.
• 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. 
• 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.
Filmovertræk: polyvinylalkohol, titandioxid (E171), macrogol 3350, talkum og indigo carmine aluminium lake (E132). 
Film-coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc and indigo carmine aluminium lake (E132).
Den gennemsnitlige fordelingsvolumen ved steady state af oral naltrexon og bupropion, givet som naltrexon/bupropion, Vss/F, var hhv. 5697 liter og 880 liter. 
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.
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. 
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.
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. 
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.
Efter to gange daglig administration af naltrexon/bupropion akkumulerer naltrexon ikke, mens 6-betanaltrexol akkumulerer over tid. 
Following twice daily administration of naltrexone / bupropion, naltrexone does not accumulate, while 6-beta-naltrexol accumulates over time.
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. 
Preclinical data suggests that naltrexone and bupropion may have greater than additive effects in this region to reduce food intake when administered together.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blister efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Mysimba bør derfor ikke anvendes til børn og unge under 18 år. 
Therefore Mysimba should not be used in children and adolescents below 18 years.
Farmakoterapeutisk kategori: A08AA centralt virkende antifedme produkter, ATC-kode: A08AA62 bupropion og naltrexon 
Pharmacotherapeutic group: A08AA Centrally acting antiobesity products, ATC code: A08AA62 bupropion and naltrexone.
metadon) eller patienter i akut opiat-afvænning 
(e.g., methadone), or patients in acute opiate withdrawal
Anvendelse af naltrexon/bupropion med andre OCT2-substrater (fx. metformin) i kliniske forsøg indikerer ikke behov for dosisjustering eller andre forholdsregler. 
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.
• steroider (undtagen dråber, cremer eller lotion til øjen- og hudsygdomme eller inhalatorer til vejrtrækningslidelser som astma) 
• steroids (except drops, creams, or lotions for eye and skin conditions or inhalers for breathing disorders such as asthma);
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Orexigen Therapeutics Ireland Limited 2nd Floor 
MARKETING AUTHORISATION HOLDER Orexigen Therapeutics Ireland Limited 2nd Floor
‘last observation carried forward' (LOCF). 
Results are based on last-observation-carriedforward (LOCF).
PharmaSwiss Česká republika s.r.o. 
Česká republika PharmaSwiss Česká republika s.r.o.
sikkerhed eller tolerabilitet af igangværende behandling, herunder bekymring for forhøjet blodtryk (se pkt. 
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).
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. 
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.
Blodtryksudsving 
Blood pressure fluctuation
Undersøgelse NB-304 blev gennemført hos forsøgspersoner, der var overvægtige eller svært overvægtige og havde type 2-diabetes mellitus. 
Study NB-304 was conducted in subjects who were overweight or obese and had type 2 diabetes mellitus.
Ældre personer: Naltrexons/bupropions farmakokinetik er ikke vurderet i den ældre befolkning. 
Elderly people: The pharmacokinetics of naltrexone / bupropion have not been evaluated in the elderly population.
Der eksisterer potentiale for en interaktion mellem naltrexon/bupropion og lægemidler, der inducerer eller er substrater af CYP2B6-isozymet. 
The potential exists for a drug interaction between naltrexone / bupropion and drugs that induce or are substrates of the CYP2B6 isozyme.
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. 
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.
Naltrexon/bupropion øgede metoprolol AUC og Cmax med henholdsvis ca. 4- og 2- gange i forhold til metoprolol alene. 
Naltrexone / bupropion increased metoprolol AUC and Cmax by approximately 4- and 2-fold, respectively, relative to metoprolol alone.
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. 
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.
Amning Naltrexon og bupropion og deres metabolitter udskilles i human mælk. 
Breast-feeding Naltrexone and bupropion and their metabolites are excreted in human milk.
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. 
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.
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. 
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.
Virkningerne af kombineret bupropion og naltrexon brug er ikke undersøgt hos dyr. 
The effects of combined bupropion and naltrexone use have not been studied in animals.
• samtidig administration af lægemidler, der kan nedsætte krampetærsklen, herunder antipsykotika, antidepressiva, malariamidler, tramadol, theophyllin, systemiske steroider, quinoloner og sederende antihistaminer 
• concomitant administration of medicinal products that may lower the seizure threshold, including antipsychotics, antidepressants, antimalarials, tramadol, theophylline, systemic steroids, quinolones and sedating antihistamines
En patient med formodet DILI bør stoppe med at tage naltrexon/bupropion. 
A patient with suspected DILI should stop taking naltrexone / bupropion.
Forværring af psoriasis (B), seborré (N) 
Uncommon Exacerbation of psoriasis (B), Seborrhea (N)
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. 
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.
Hvis patienter oplever klinisk relevante og vedvarende stigninger i blodtryk eller puls som følge af behandling med naltrexon/bupropion, bør det seponeres. 
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.
Relevansen af disse observationer for menneskers fertilitet er ikke kendt (se pkt. 
The relevance of these observations to human fertility is not known (see section 5.3).
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. 
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.
*** 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. 
*** 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.
Dystoni, svækket hukommelse, parkinsonisme, rastløshed 
Dystonia, Memory impairment, Parkinsonism, Restlessness
Der er set leverændringer i dyreforsøg med bupropion, men disse afspejler virkningen af en leverenzyminducer. 
Liver changes are seen in animal studies with bupropion but these reflect the action of a hepatic enzyme inducer.
Mere alvorlige overfølsomhedsreaktioner, herunder angioødem, dyspnø/bronchospasme og anafylaktisk chok. 
More severe hypersensitivity reactions including angioedema, dyspnoea/ bronchospasm and anaphylactic shock.
Meget almindelige bivirkninger (påvirker mere end 1 ud af 10 personer): - Kvalme eller opkastning - Forstoppelse - Hovedpine 
Very common side effects (may affect more than 1 in 10 people): - Feeling sick (nausea), being sick (vomiting) - Constipation - Headache
Hvis du oplever, at du besvimer, får muskelsvaghed eller krampeanfald under behandling, må du ikke føre motorkøretøj eller betjene maskiner. 
If you experience fainting, muscle weakness or fits during treatment, do not drive or use machines.
CYP2B6-induktorer, -hæmmere og -substrater 
CYP2B6 inducers, inhibitors and substrates
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. 
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.
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. 
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.
- Erythema multiforme og Stevens-Johnsons syndrom Ikke kendt - hyppigheden kan ikke estimeres ud fra de forhåndenværende data hos personer, der tager Mysimba. 
- Erythema multiforme and Stevens Johnson Syndrome Not known - frequency cannot be estimated from the available data in people taking
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. 
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.
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. 
In clinical studies, 23.8% of subjects receiving naltrexone / bupropion and 11.9% of subjects receiving placebo discontinued treatment due to an adverse event.
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. 
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.
Reproduktionstoksicitet: 
Reproduction toxicity:
Se sidst i punkt 4.8, hvordan du indberetter bivirkninger. 
See the end of section 4 for how to report side effects.
Tabletterne skal helst tages sammen med mad (se pkt. 
The tablets should preferably be taken with food (see section 5.2).
Naltrexon var også negativ i en in vivo musemikronukleustest. 
Naltrexone was also negative in an in vivo mouse micronucleus assay.
Naltrexon/bupropion er ikke undersøgt i forbindelse med alfa-adrenerge blokkere eller clonidin. 
Naltrexone / bupropion has not been studied in conjunction with alpha-adrenergic blockers or clonidine.
Bupropion og dets metabolitter hæmmer CYP2D6. 
Bupropion and its metabolites inhibit CYP2D6.
Der er ingen kendte farmakokinetiske interaktioner mellem naltrexon og alkohol. 
There are no known pharmacokinetic interactions between naltrexone and alcohol.
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). 
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).
Alternativt kan behandlingsophør overvejes (se pkt. 
Alternatively, treatment cessation might be considered (see sections 4.7 and
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. 
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.
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. 
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.
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. 
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.
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). 
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).
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 %. 
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%.
Indigocarmin, aluminium lake (E132) 6.2 Uforligeligheder 
Indigo Carmine Aluminium Lake (E132) 6.2 Incompatibilities Not applicable.
Der var ingen konsistente ændringer i naltrexon eller bupropionmetabolitter relateret til varierende grader af nedsat leverfunktion. 
There were no consistent changes in naltrexone or bupropion metabolites related to varying degrees of hepatic impairment.
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. 
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.
Mysimba indeholder laktose (et sukkerstof). 
Mysimba contains lactose (a type of sugar)
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/14/988/001-002 
MARKETING AUTHORISATION NUMBER(S) EU/1/14/988/001-002
• Lægemidler til behandling af HIV-infektion og AIDS, såsom efavirenz og ritonavir 
• Medicines used in the treatment of HIV infection and AIDS, such as efavirenz and ritonavir;
Bupropion metaboliseres i udstrakt grad med tre aktive metabolitter: hydroxybupropion, threohydrobupropion og erythrohydrobupropion. 
Bupropion is extensively metabolised with three active metabolites: hydroxybupropion, threohydrobupropion and erythrohydrobupropion.
Der skal gå mindst 14 dage mellem seponering af MAOI og igangsættelse af behandling med naltrexon/bupropion (se pkt. 
At least 14 days should elapse between discontinuation of MAOI and initiation of treatment with naltrexone / bupropion (see section 4.5)
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. 
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).
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. 
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.