FrancophonIA/ELRC3.0 huggingface dataset:
English: • medicines to help you to sleep (sedatives such as diazepam).
Danish: • lægemidler der hjælper dig med at sove (beroligende midler såsom diazepam)
English: A decrease in the pregnancy rate of mated female rats also occurred.
Danish: Der forekom også et fald i graviditeten hos parrede hunrotter.
English: After you stop treatment with Mysimba you may be more sensitive to low doses of opiates (see “Do not take Mysimba”).
Danish: Når du stopper behandlingen med Mysimba, kan du blive mere følsom over for lave doser af opiater (se “Tag ikke Mysimba”).
English: CYP2D6 substrates
Danish: CYP2D6 substrater
English: Non-clinical data on individual components reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Danish: Non-kliniske data for individuelle komponenter viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhed, farmakologi, toksicitet efter gentagne doser, gentoksicitet og karcinogenicitet.
English: The combination has not been tested in reproductive toxicity studies.
Danish: Kombinationen er ikke afprøvet i undersøgelser om reproduktionstoksicitet.
English: The body mass index is calculated as the measured body weight (kg) divided by the measured height squared (m2).
Danish: BMI beregnes som den målte kropsvægt (kg) divideret med den målte højde i anden (m2).
English: If you have problems with your liver or kidney, or if you are older than 65, and depending on the severity of your problems, your doctor may carefully consider whether this medicine is suitable for you or recommend that you take a different dose, and monitor you more closely for potential side effects.
Danish: Hvis du har problemer med din lever eller dine nyrer, eller hvis du er ældre end 65 år, og afhængig af sværhedsgraden af dine problemer, kan din læge nøje overveje, om dette lægemiddel er passende for dig eller anbefale, at du tager en anden dosis, og følge dig tæt for mulige bivirkninger.
English: Mysimba is not recommended if you are over 75 years.
Danish: Mysimba frarådes, hvis du er over 75 år.
English: The two co-primary endpoints were percent change from baseline body weight and the proportion of subjects achieving ≥5% total decreased body weight.
Danish: De to co-primære endpoints var procentvis ændring fra baseline kropsvægt og andelen af forsøgspersoner, der opnåede ≥5 % total nedsat kropsvægt.
English: Based on these results, there are no dose adjustments recommended for patients with mild renal impairment.
Danish: Baseret på disse resultater, anbefales der ikke dosisjusteringer for patienter med mild nyreinsufficiens.
English: If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis du har fået at vide, at du har en intolerance over for visse sukkerarter, skal du kontakte din læge, inden du begynder at tage dette lægemiddel.
English: These results suggest that most of the total weight loss was attributable to a reduction in adipose tissue, including visceral adipose.
Danish: Disse resultater antyder, at det meste af det samlede vægttab kunne tilskrives en reduktion i fedtvæv, herunder visceralt fedtvæv.
English: Human overdose experience
Danish: Erfaring med human overdosering
English: Any effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Der blev kun observeret eventuelle virkninger i andre non-kliniske forsøg ved eksponeringer, der i væsentlig grad overstiger den maksimale humane eksponering, hvilket indikerer ringe relevans for klinisk brug.
English: • history of head trauma
Danish: • anamnese af hovedtraume
English: Rhabdomyolysis is an abnormal breakdown of muscle tissue which can lead to kidney problems.
Danish: Rhabdomyolyse er en unormal nedbrydning af muskelvæv, som kan føre til nyreproblemer.
English: • quinolones (antibiotics such as ciprofloxacine to treat infections);
Danish: • quinoloner (antibiotika, såsom ciprofloxacin til behandling af infektioner)
English: Swallow your tablets whole.
Danish: Synk tabletterne hele.
English: Plasma protein binding is not extensive for naltrexone (21%) or bupropion (84%) indicating low potential for drug interactions by displacement.
Danish: Plasmaproteinbinding er ikke omfattende for naltrexon (21 %) eller bupropion (84 %), hvilket angiver lavt potentiale for lægemiddelinteraktioner ved forskydning.
English: Polska Valeant Pharma Poland sp. z o.o.
Danish: Valeant Pharma Poland sp. z o.o.
English: Electrocardiogram change (N)
Danish: Almindelig Ændring i elektrokardiogram (N)
English: In addition, there have been rare spontaneous postmarketing reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock associated with bupropion.
Danish: Desuden har der været sjældne spontane postmarketingrapporter vedrørende erythema multiforme, Stevens-Johnson syndrom og anafylaktisk chok forbundet med bupropion.
English: Naltrexone and its metabolites are excreted primarily by the kidney (37 to 60% of the dose).
Danish: Naltrexon og dets metabolitter udskilles primært via nyrerne (37 til 60 % af dosis).
English: Naltrexone / bupropion was also evaluated in combination with intensive behavioural modification counseling in the NB-302 study.
Danish: Naltrexon/bupropion blev også evalueret i kombination med intensiv adfærdsmæssig modifikationsrådgivning i NB-302-undersøgelsen.
English: The major metabolite of naltrexone is 6-beta-naltrexol.
Danish: Naltrexons vigtigste metabolit er 6-beta-naltrexol.
English: • tramadol (a painkiller belonging to the class of opiates);
Danish: • tramadol (et smertestillende middel, tilhører klassen af opiater)
English: Genotoxicity data indicate that bupropion is a weak bacterial mutagen, but not a mammalian mutagen, and therefore is of no concern as a human genotoxic agent.
Danish: Genotoksiske data indikerer, at bupropion er et svagt bakterielt mutagen, men ikke et pattedyrsmutagen og er derfor uden betydning som et humant genotoksisk stof.
English: Food effect:
Danish: Påvirkning fra mad:
English: • Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det (de) aktive stof(fer) eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Effect on body composition
Danish: Virkning på kropssammensætning
English: You must stop taking these medicines for at least 14 days before starting Mysimba (see “Do not take Mysimba”).
Danish: Du skal stoppe med at tage disse lægemidler mindst 14 dage før du begynder at tage Mysimba (se “Tag ikke Mysimba”).
English: • Medicines that may, when used alone or in combination with naltrexone/bupropion, increase the risk of fits such as:
Danish: • Lægemidler, der kan, når det anvendes alene eller i kombination med naltrexon/bupropion, øge risikoen for krampeanfald som fx.:
English: Plasma protein binding of hydroxybupropion is similar to that of bupropion (84%) whereas the other two metabolites have approximately half the binding.
Danish: Hydroxybupropions plasmaproteinbinding svarer til bupropions (84 %), mens de to andre metabolitter har cirka halvdelen af bindingen.
English: The consumption of alcohol during naltrexone / bupropion treatment should be minimised or avoided.
Danish: Forbruget af alkohol under naltrexon/bupropion-behandling bør minimeres eller undgås.
English: Stevens Johnson Syndrome is a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
Danish: StevensJohnsons syndrom er en sjælden hudlidelse med alvorlige vabler og blødning i læberne, øjne, mund, næse og kønsorganer.
English: Baseline mean BMI was 36 kg/m2 and mean waist circumference was 110 cm.
Danish: Baseline betyder, at BMI var 36 kg/m2 og betyder, at taljemålet var 110 cm.
English: When feasible, the option of therapeutic drug monitoring should be considered for medicinal products with a narrow therapeutic index, such as tricyclic antidepressants.
Danish: Når det er muligt, så bør muligheden for terapeutisk lægemiddelmonitorering overvejes for lægemidler med et snævert terapeutisk indeks, fx. tricykliske antidepressiva.
English: Degree of hepatic impairment should be assessed using the Child-Pugh score.
Danish: Leverunsufficiensens sværhedsgrad skal evalueres ved hjælp af Child-Pugh-score.
English: Following oral administration of 200 mg of 14C-bupropion hydrochloride in humans, 87% and 10% of the radioactive dose were recovered in the urine and feces, respectively.
Danish: Efter oral administration af 200 mg 14C-bupropion-hydrochlorid hos mennesker, blev hhv. 87 % og 10 % af den radioaktive dosis genfundet i urinen og fæces.
English: • you have uncontrolled coronary artery disease (a heart disease caused by poor blood flow in the blood vessels of the heart) with symptoms such as angina (characterised by chest pain) or a recent heart attack.
Danish: • du har ukontrolleret koronararteriesygdom (en hjertesygdom forårsaget af dårlig blodgennemstrømning i blodkarrene i hjertet) med symptomer som angina (karakteriseret ved brystsmerter) eller et nyligt hjerteanfald.
English: • Patients undergoing acute alcohol or benzodiazepine withdrawal
Danish: • Patienter med igangværende akut alkohol- eller benzodiazepin-afvænning
English: If your blood pressure or heart rate increases significantly, you may need to stop taking Mysimba.
Danish: Hvis dit blodtryk eller din puls stiger betydeligt, så kan det være nødvendigt at stoppe med Mysimba.
English: Additionally, Week 16 Responders who received naltrexone / bupropion had a high retention rate with 87% completing 1 year of treatment.
Danish: Derudover havde Uge 16 Respondenter, der fik naltrexon/bupropion, en høj retentionsrate med 87 %, der gennemførte 1 års behandling.
English: Though less potent than naltrexone, 6-beta-naltrexol is eliminated more slowly and thus circulates at much higher concentrations than naltrexone.
Danish: Selvom det er mindre potent end naltrexon, så elimineres 6-beta-naltrexol langsommere og cirkulerer dermed ved meget højere koncentrationer end naltrexon.
English: The relevance of these observations to human fertility is not known.
Danish: Relevansen af disse observationer for menneskers fertilitet er ikke kendt.
English: • you have high blood pressure before taking Mysimba, because it can become worse.
Danish: • du har forhøjet blodtryk, før du tager Mysimba, fordi det kan blive værre.
English: - Rhabdomyolysis
Danish: - Rhabdomyolyse
English: The fraction of the oral dose of bupropion excreted unchanged was 0.5%, a finding consistent with the extensive metabolism of bupropion.
Danish: Fraktionen af den orale dosis af bupropion, der blev udskilt uforandret, var 0,5 %, en konstatering i overensstemmelse med bupropions omfattende metabolisering.
English: Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of
Danish: Mysimba er indiceret som et supplement til en kaloriereduceret kost og øget fysisk aktivitet til regulering af vægt hos voksne patienter (≥ 18 år) med en indledende BMI (Body Mass Index) på
English: Elevation of blood pressure
Danish: Forhøjelse af blodtryk
English: • Patients with a known central nervous system tumour
Danish: • Patienter med en kendt tumor i centralnervesystemet
English: Talk to your doctor or pharmacist before taking Mysimba.
Danish: Fortæl det til lægen eller på apoteket før du tager Mysimba.
English: Data in animals suggest a potential for abuse of bupropion.
Danish: Data hos forsøgsdyr tyder på en risiko for misbrug af bupropion.
English: If you have thoughts about harming yourself or other distressing thoughts, or if you are depressed and notice that you feel worse or develop new symptoms, contact your doctor or go to a hospital straight away.
Danish: Hvis du har tanker om at skade dig selv eller andre foruroligende tanker, eller hvis du er deprimeret og bemærker, at du har det værre eller udvikler nye symptomer, skal du straks kontakte din læge eller opsøge et hospital.
English: The clinical relevance of these equivocal findings is unknown.
Danish: Den kliniske relevans af disse tvetydige fund kendes ikke.
English: Overall adherence was similar between trials, and similar between treatment groups.
Danish: Samlet komplians var ens mellem forsøg og ens mellem behandlingsgrupper.
English: • ≥ 30 kg/m2 (obese), or
Danish: • ≥ 30 kg/m2 eller mere (svær overvægt), eller
English: The derived value for renal excretion of naltrexone after oral administration, adjusting for plasma protein binding, is 89 mL/min.
Danish: Den afledte værdi for renal udskillelse af naltrexon efter oral administration, justeret for plasmaproteinbinding, er 89 ml/min.
English: Naltrexone / bupropion (-3.7%) was significantly (p<0.001) more efficacious than placebo (-1.7%) treatment in this population.
Danish: Naltrexon/bupropion (-3,7 %) var signifikant (p <0,001) mere effektiv end placebobehandling (-1,7 %) hos denne population.
English: You will have your blood pressure and heart rate measured before you start taking Mysimba and while you are taking it.
Danish: Du vil få målt dit blodtryk og din puls, før du begynder at tage Mysimba og mens du tager det.
English: Since there is limited information on the systemic exposure to naltrexone and bupropion in infants/newborns being breast-fed, a risk to the newborns/infants cannot be excluded.
Danish: Da der er begrænsede oplysninger om den systemiske eksponering for naltrexon og bupropion hos spædbørn/nyfødte, der ammes, så kan der ikke udelukkes en risiko for nyfødte/spædbørn.
English: • if you have diabetes for which you use insulin or oral medicines that may cause low sugar levels in your blood (hypoglycaemia); or
Danish: • hvis du har diabetes, som du bruger insulin eller oral medicin til, der kan forårsage lavt sukkerindhold i blodet (hypoglykæmi); eller
English: These components affect two principal areas of the brain, specifically the arcuate nucleus of the hypothalamus and the mesolimbic dopaminergic reward system.
Danish: Disse komponenter påvirker to vigtige områder i hjernen, specielt den bueformede kerne i hypothalamus og det mesolimbiske dopaminerge belønningssystem.
English: Following oral administration of a single 150 mg dose of bupropion hydrochloride, there was no statistically significant difference in Cmax, half-life, Tmax, AUC, or clearance of bupropion or its active metabolites between smokers and nonsmokers.
Danish: Efter oral administration af en enkelt 150 mg dosis af bupropion-hydrochlorid, var der ingen statistisk signifikant forskel i Cmax, halveringstid, Tmax, AUC eller bupropions clearance eller dets aktive metabolitter mellem rygere og ikke-rygere.
English: The ≥5% weight loss threshold at Week 16 had 86.4% positive predictive value and 84.8% negative predictive value for determining whether a subject treated with naltrexone / bupropion would achieve at least 5% weight loss at Week 56.
Danish: Vægttabstærsklen på ≥5 % ved uge 16 havde 86,4 % positiv prædiktiv værdi og 84,8 % negativ prædiktiv værdi til bestemmelse af, om forsøgspersonen, der blev behandlet med naltrexon/bupropion ville opnå mindst 5 % vægttab i uge 56.
English: If you have a fit (seizure), you should stop taking Mysimba and consult your doctor immediately.
Danish: Hvis du får et krampeanfald, bør du stoppe med at tage Mysimba og straks kontakte din læge.
English: NB-304 evaluated subjects with type 2 diabetes not achieving glycaemic goal of HbA1c <7% (53 mmol/mol) with oral anti-diabetes agents or on diet and exercise alone.
Danish: NB-304 evaluerede forsøgspersoner med type 2-diabetes, der ikke opnåede glykæmisk HbA1c <7 % (53 mmol/mol) med orale anti-diabetes agenter eller kun med diæt og motion.
English: Obesity in adults over 18 years of age is defined as a body mass index of greater than or equal to 30 and overweight in adults over 18 years of age is defined as a body mass index greater than or equal to 27 and less than 30.
Danish: Svær overvægt hos voksne over 18 år er defineret som et BMI (body mass index) på mere end eller lig med 30 og overvægt hos voksne over 18 år er defineret som et BMI på mere end eller lig med 27 og mindre end 30.
English: Symptoms include severe muscle cramps, muscle pain or muscle weakness.
Danish: Symptomer omfatter svære muskelkramper, muskelsmerter eller muskelsvaghed.
English: 6.5 Nature and contents of container PVC/PCTFE/PVC/Aluminium blisters.
Danish: 6.5 Emballagetype og pakningsstørrelser PVC/PCTFE/PVC/Aluminium-blister.
English: Blood pressure and pulse should be measured prior to initiation of therapy with naltrexone / bupropion and should be assessed at regular intervals consistent with usual clinical practice.
Danish: Blodtryk og puls skal måles før igangsættelse af behandling med naltrexon/bupropion og bør vurderes med jævne mellemrum i overensstemmelse med sædvanlig klinisk praksis.
English: Naltrexone is primarily metabolized to 6-beta-naltrexol by the dihydrodiol dehydrogenases (DD1, DD2 and DD4).
Danish: Naltrexon metaboliseres primært til 6-beta-naltrexol af dihydrodiol dehydrogenaser (DD1, DD2 og DD4).
English: Naltrexone / bupropion has influence on the ability to drive and use machines.
Danish: Naltrexon/bupropion har en indvirkning på evnen til at køre eller bruge maskiner.
English: In contrast, naltrexone tested positive in the following assays: Drosophila recessive lethal frequency assay, non-specific DNA damage in repair tests with E. coli and WI-38 cells, and urinalysis for methylated histidine residues.
Danish: I modsætning hertil testede naltrexon positiv i de følgende tests: Drosofila recessiv letal frekvenstest, ikke-specifik DNA-skade i reparationstest med E. coli og WI-38 celler og urinanalyse for methylerede histidinrester.
English: No events of nausea, constipation, or vomiting were considered serious.
Danish: Ingen tilfælde af kvalme, forstoppelse eller opkastning blev betragtet som alvorlige.
English: When α-MSH is released, POMC neurons simultaneously release β-endorphin, an endogenous agonist of the mu-opioid receptors.
Danish: Når α-MSH er frigivet, så frigiver POMC-neuroner samtidig β-endorphin, en endogen agonist af mu-opioidreceptorer.
English: * Difference from placebo, p<0.001.
Danish: * Forskel fra placebo, p<0,001
English: Patients who experience dizziness, somnolence, loss of consciousness or seizure should be advised to avoid driving or operating machines until these adverse effects have resolved.
Danish: Patienter, der oplever svimmelhed, døsighed, bevidsthedstab eller krampeanfald, bør rådes til at undgå at føre motorkøretøj eller betjene maskiner, indtil disse bivirkninger er gået væk.
English: There were no differences in bioavailability, as measured by AUC, of naltrexone or bupropion when administered in combination compared to each administered alone.
Danish: Der var ingen forskelle i biotilgængelighed, som målt ved AUC, på naltrexon eller bupropion, når de administreres i kombination i forhold til når de hver administreres alene.
English: Similar clinical drug interactions resulting in increased pharmacokinetic exposure of CYP2D6 substrates have also been observed with bupropion as a single medicinal product with desipramine and venlafaxine.
Danish: Lignende kliniske lægemiddelinteraktioner, der resulterer i øget farmakokinetisk eksponering af CYP2D6-substrater, er også blevet observeret med bupropion som et enkelt lægemiddel med desipramin og venlafaxin.
English: Dose reduction is not necessary in patients with mild renal impairment.
Danish: Dosisreduktion er ikke nødvendig hos patienter med let nedsat nyrefunktion.
English: Uncommon Postural hypotension (B), Vasodilatation (B)
Danish: Postural hypotension (B), vasodilatation (B)
English: Although clinical data do not identify a pharmacokinetic interaction between bupropion and alcohol, there have been rare reports of adverse neuropsychiatric events or reduced alcohol tolerance in patients drinking alcohol during bupropion treatment.
Danish: Selvom kliniske data ikke identificerer en farmakokinetisk interaktion mellem bupropion og alkohol, så har der været sjældne rapporter om uønskede neuropsykiatriske hændelser eller reduceret alkoholtolerance hos patienter, der drikker alkohol under bupropionbehandling.
English: Greater HbA1c improvement compared to placebo was observed at the first post-baseline measurement (Week 16, p<0.001).
Danish: Der blev observeret større HbA1c-forbedring i forhold til placebo ved den første post baseline måling (uge 16, p <0,001).
English: Bupropion and its metabolites competitively inhibit the OCT2 in the basolateral membrane of the renal tubule responsible for creatinine secretion, in a manner similar to the OCT2 substrate cimetidine.
Danish: Bupropion og dets metabolitter hæmmer kompetitivt OCT2 i den basolaterale membran af den renale tubulus, der er ansvarlig for kreatininsekretion på en måde, der svarer til OCT2 substrat cimetidin.
English: • Patients receiving any concomitant treatment containing bupropion or naltrexone
Danish: • Patienter i enhver form for samtidig behandling, der indeholder bupropion eller naltrexon
English: The safety and tolerability of naltrexone / bupropion should be assessed at regular intervals.
Danish: Sikkerheden og tolerabiliteten af naltrexon/bupropion bør vurderes med jævne mellemrum.
English: Events were generally self-limited; the majority of events resolved within 4 weeks and almost all resolved by Week 24.
Danish: De fleste tilfælde forsvandt inden for 4 uger og næsten alle forsvandt inden uge 24.
English: Treatment adherence rates for the integrated Phase 3 studies were: 67% NB vs. 74% Placebo at 16 weeks, 63% NB vs. 65% Placebo at 26 Weeks, 55% NB vs. 55% Placebo at 52Weeks.
Danish: Behandlingskomplians for de integrerede fase 3-studier var: 67 % NB vs. 74 % placebo efter 16 uger, 63 % NB vs. 65 % placebo efter 26 uger, 55 % NB vs. 55 % placebo efter 52 uger.
English: The need for continued treatment should be evaluated after 16 weeks (see section 4.1) and reevaluated annually.
Danish: Behovet for fortsat behandling skal evalueres efter 16 uger (se pkt.
English: Naltrexone and 6-beta-naltrexol are not metabolised by cytochrome P450 enzymes and in vitro studies indicate that there is no potential for inhibition or induction of important isozymes.
Danish: Naltrexon og 6-beta-naltrexol metaboliseres ikke af cytochrom P450-enzymer og in vitroundersøgelser indikerer, at der ikke er potentiale for hæmning eller induktion af vigtige isozymer.
English: Blocking this inhibitory feedback loop with naltrexone is proposed to facilitate a more potent and longer-lasting activation of POMC neurons, thereby amplifying the effects of bupropion on energy balance.
Danish: Blokering denne hæmmende feedback-loop med naltrexon menes at fremme en mere potent og længerevarig aktivering af POMC-neuroner og derved forstærke virkningerne af bupropion på energibalancen.
English: The most serious clinical implications of combined use of bupropion and naltrexone overdose are likely related to bupropion.
Danish: De alvorligste kliniske implikationer af kombineret anvendelse af bupropion- og naltrexon-overdosis er sandsynligvis relateret til bupropion.
English: Blue, biconvex, round tablet of 12.0-12.2 mm diameter debossed with “NB-890” on one side.
Danish: Blå, bikonveks, rund tablet på 12,0-12,2 mm i diameter præget med “NB-890” på den ene side.
English: • as treatment with naltrexone / bupropion may result in lowered glucose in patients with diabetes, the dose of insulin and/or oral diabetic medicinal products should be assessed to minimise the risk of hypoglycaemia, which could predispose patients to seizure
Danish: • da behandling med naltrexon/bupropion kan resultere i nedsat glukose hos patienter med diabetes, bør dosis af insulin og/eller orale diabetiske lægemidler vurderes for at minimere risikoen for hypoglykæmi, som kan prædisponere patienterne for krampeanfald
English: • theophylline (used in the treatment of asthma);
Danish: • teofyllin (bruges til behandling af astma)