FrancophonIA/ELRC3.0 huggingface dataset:
English: • severe disabling psoriasis (an inflammatory disease causing red, scaly patches on the skin) in adults when other treatments have not worked well enough;
Danish: • alvorlig invaliderende psoriasis (en betændelsessygdom, der medfører områder med rød og afskallende hud) hos voksne, når andre behandlinger ikke har virket godt nok
English: • severe juvenile idiopathic arthritis (inflammation of joints in children) in patients from 3 years of age when NSAIDs (non-steroidal anti-inflammatory drugs) have not worked well enough;
Danish: • alvorlig børnegigt (juvenil idiopatisk artritis), dvs. betændelse i leddene hos børn fra 3 år og opefter, når non-steroide antiinflammatoriske lægemidler ikke har haft tilstrækkelig virkning
English: How is Jylamvo used?
Danish: Hvordan anvendes Jylamvo?
English: • severe psoriatic arthritis (inflammation of joints that occurs in patients with psoriasis) in adults;
Danish: • alvorlig psoriasisartrit (betændelse i leddene hos patienter med psoriasis) hos voksne
English: • active rheumatoid arthritis (a disease causing inflammation in joints) in adults;
Danish: • aktiv leddegigt (reumatoid artrit), der er en sygdom, som forårsager betændelse i leddene hos voksne
English: What benefits of Jylamvo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Jylamvo?
English: How does Jylamvo work?
Danish: Hvordan virker Jylamvo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jylamvo have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Jylamvo.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen indsender periodiske opdaterede sikkerhedsindberetninger for dette lægemiddel i overensstemmelse med de krav i listen over EU-referencedatoer (EURD-listen), der er fastsat i artikel 107c (7) i direktiv 2001/83/EF og offentliggjort på den europæiske webportal om lægemidler.
English: Condition to the marketing authorisations
Danish: Betingelse for markedsføringstilladelserne
English: National Competent Authorities (NCAs) of Member State(s) or Reference Member State(s) (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaten (-staterne) eller i givet fald i referencemedlemsstaten (-staterne) sikrer, at indehaveren (indehaverne) af markedsføringstilladelse opfylder følgende betingelser:
English: Annex IV Condition to the marketing authorisations
Danish: Bilag IV Betingelse for markedsføringstilladelserne
English: General supportive and symptomatic measures are also recommended.
Danish: Generelle understøttende og symptomatiske forholdsregler anbefales også.
English: The dose will be gradually adapted as follows:
Danish: Dosis vil blive gradvist tilpasset på følgende måde:
English: You should talk to your doctor, especially if:
Danish: Du bør tale med din læge, især hvis:
English: Someone who has had a fit may be confused afterwards and may not remember what has happened.
Danish: Nogen, der har haft et anfald, kan være forvirret bagefter og kan måske ikke huske, hvad der er sket.
English: The study is to be monitored regularly by a Data Monitoring Committee (DMC).
Danish: Undersøgelsen vil løbende blive overvåget af et dataovervågningsudvalg (Data Monitoring Committee - DMC).
English: Seizure was reported in approximately one third of these overdose cases.
Danish: Der blev rapporteret om anfald i ca. en tredjedel af disse tilfælde af overdosis.
English: However, only Caucasian and Black subjects were investigated to a significant extent.
Danish: Det var dog kun kaukasiske og sorte forsøgspersoner, der blev undersøgt i et betydeligt omfang.
English: Fasting insulin, % change
Danish: Fastende insulin, % ændring
English: Suicide and suicidal behaviour
Danish: Selvmord og selvmordsadfærd
English: Bupropion is indicated for the treatment of depression in some countries.
Danish: Bupropion er indiceret til behandling af depression i nogle lande.
English: No dosage adjustment is necessary based on gender or race.
Danish: Dosisjustering er ikke nødvendig på baggrund af køn eller race.
English: HbA1c, % Not applicable
Danish: HbA1c, % Ikke relevant
English: This is important because some conditions make it more likely that you could have side effects (see also section 4).
Danish: Dette er vigtigt, fordi nogle forhold gør det mere sandsynligt, at du kunne få bivirkninger (se også punkt 4).
English: EEG monitoring is also recommended for the first 48 hours post-ingestion.
Danish: Der anbefales også EEG-monitorering i de første 48 timer efter indtagelse.
English: • medicines used to prevent malaria;
Danish: • lægemidler, der anvendes til at forebygge malaria
English: Submission of the protocol by 31 March
Danish: Indsendelse af protokollen inden 31. marts 2015
English: • if you regularly drink alcohol (see “Mysimba with alcohol”);
Danish: • hvis du jævnligt drikker alkohol (se “Mysimba med alkohol”);
English: 95% confidence intervals calculated as LS Mean ± 1.96 × Standard Error.
Danish: 95 % konfidensintervaller beregnet som LS Mean ± 1,96 × Standard Error.
English: These symptoms may resemble serum sickness.
Danish: Disse symptomer kan ligne serumsyge.
English: Package leaflet: Information for the patient
Danish: INDLÆGSSEDDEL: Information til patienten
English: Cardiac rhythm and vital signs should be monitored.
Danish: Hjerterytme og vitale tegn bør overvåges.
English: You may need to take Mysimba for at least 16 weeks to have its full effect.
Danish: Det kan være nødvendigt at tage Mysimba i mindst 16 uger for at få den fulde virkning.
English: • if you have had a serious head injury or head trauma;
Danish: • hvis du har haft en alvorlig skade i hovedet eller hovedtraume;
English: ** The incidence of seizures is approximately 0.1% (1/1,000).
Danish: ** Forekomsten af krampeanfald er ca. 0,1 % (1/1.000).
English: Upon initiating treatment, the dose should be escalated over a 4-week period as follows:
Danish: Efter påbegyndelse af behandling bør dosis øges over en 4-ugers periode som følger:
English: 28-Week Data
Danish: 28-ugers data
English: The study protocol, including key aspects of the DMC charter, has to be agreed before initiation of the study.
Danish: Undersøgelsesprotokollen, herunder centrale aspekter af DMC-autorisationen, skal aftales inden påbegyndelse af undersøgelsen.
English: You should inform your doctor before taking this medicine:
Danish: Du bør informere din læge, før du tager dette lægemiddel:
English: • medicines for depression and other mental health problems;
Danish: • lægemidler mod depression og andre psykiske problemer
English: If you do drink a lot now, do not just stop suddenly, because that may put you at risk of having a fit.
Danish: Hvis du drikker meget nu, så må du ikke bare stoppe pludseligt, fordi det kan øge din risiko for at få et krampeanfald.
English: This medicine works on areas on the brain involved in the control of food intake and energy expenditure.
Danish: Dette lægemiddel virker på områder i hjernen, der er involveret i kontrollen af fødeindtagelse og energiforbrug.
English: Tell your doctor if you are taking any of the following medicines, as your doctor will closely monitor you for side effects:
Danish: Fortæl lægen, hvis du tager nogen af følgende lægemidler, da din læge så vil overvåge dig tæt for bivirkninger:
English: There was no effect on male fertility at this dose level.
Danish: Der var ingen effekt på mandlig fertilitet ved dette dosisniveau.
English: An adequate airway, oxygenation, and ventilation should be ensured.
Danish: Der bør sikres passende luftveje, ilttilførsel og ventilation.
English: 56-Week Data
Danish: 56-ugers data
English: Your doctor may suggest you do not drink alcohol while you are taking Mysimba, or try to drink as little as possible.
Danish: Din læge kan foreslå, at du ikke drikker alkohol, mens du tager Mysimba, eller prøver at drikke så lidt som muligt.
English: After 16 weeks and each year after your treatment initiation, your doctor will evaluate whether you should continue to take Mysimba.
Danish: Efter 16 uger og hvert år efter behandlingsstart vil din læge vurdere, om du skal fortsætte med at tage Mysimba.
English: Mouse and rat studies confirm the absence of carcinogenicity in these species.
Danish: Undersøgelser på mus og rotter bekræfter fraværet af karcinogenicitet hos disse arter.
English: Your doctor will closely monitor you for side effects and/or may need to adjust the dose of the other medicines or Mysimba.
Danish: Din læge vil nøje overvåge dig for bivirkninger og/eller vil måske justere dosis af de andre lægemidler eller Mysimba.
English: Patients who did not meet the early response criterion were not found to have increased tolerability or safety issues relative to patients who did have a favourable early response.
Danish: Forsøgspersoner, der ikke opfyldte early response-kriteriet, viste sig ikke at have øget tolerabilitet eller sikkerhedsproblemer i forhold til forsøgspersoner, som havde en gunstig tidlig respons.
English: • you already have or have had a condition affecting the circulation of blood in the brain (cerebrovascular disease).
Danish: • du allerede har eller har haft en sygdom, der påvirker blodcirkulationen i hjernen (cerebrovaskulær sygdom).
English: Do not delay, contact your doctor or your nearest hospital emergency department immediately.
Danish: Vent ikke, kontakt straks lægen eller den nærmeste skadestue.
English: Do not take Mysimba with:
Danish: Tag ikke Mysimba sammen med:
English: Pack sizes: 28, 112 tablets.
Danish: Pakningsstørrelse: 28, 112 tabletter.
English: Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, Ireland
Danish: Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, Irland
English: Do not drive, use any tools or machines, or perform dangerous activities until you know how this medicine affects you.
Danish: Undlad at føre motorkøretøj, bruge værktøjer eller maskiner og udfør ikke farlige aktiviteter, indtil du ved, hvordan dette lægemiddel påvirker dig.
English: Time to resolution for vomiting was typically rapid (within one week) and almost all events resolved within 4 weeks.
Danish: Tiden indtil resolution af opkastning var typisk hurtig (inden for en uge) og næsten alle tilfælde forsvandt inden for 4 uger.
English: Effect on weight loss and weight maintenance
Danish: Effekt på vægttab og vedligeholdelse af vægt
English: Your doctor may carry out a blood test to ensure that your body has cleared these medicines before starting your treatment.
Danish: Din læge kan foretage en blodprøve for at sikre, at din krop har udskilt disse lægemidler, før du starter din behandling.
English: Mysimba may be discontinued by your doctor after 16 weeks if you have not lost at least 5 percent of your initial body weight.
Danish: Mysimba kan afbrydes af din læge efter 16 uger, hvis du ikke har tabt mindst 5 procent af din oprindelige kropsvægt.
English: • if you regularly use medicines to help you to sleep (sedatives);
Danish: • hvis du regelmæssigt bruger medicin til at hjælpe dig med at sove (beroligende midler);
English: If a dose is missed, patients should not take an additional dose, but take the prescribed next dose at the usual time.
Danish: Hvis der glemmes en dosis, så bør patienter ikke tage en ekstra dosis, men tage den ordinerede næste dosis til sædvanlig tid.
English: In case of doubt, check with your doctor, who might consider to interrupt the treatment depending on your situation.
Danish: Hvis du er i tvivl, skal du tale med din læge, som kan overveje at afbryde behandlingen, afhængigt af din situation.
English: Rare - may affect up to 1 in 1,000 people taking Mysimba with risk of having a fit.
Danish: Sjælden - kan påvirke op til 1 ud af 1.000 personer, der tager Mysimba, med risiko for at få et anfald.
English: Use caution when taking Mysimba, if you are 65 years or older.
Danish: Vær forsigtig med brug af Mysimba, hvis du er 65 år eller ældre.
English: Erythema multiforme is a severe condition of the skin that may affect the mouth and other parts of the body, with red, often itchy spots starting on the limbs.
Danish: Erythema multiforme er en alvorlig tilstand i huden, som kan påvirke munden og andre dele af kroppen med røde, ofte kløende pletter, der starter på lemmerne.
English: Ask your doctor for advice before you drive and operate machines since Mysimba might make you feel dizzy and sleepy which may weaken your ability to concentrate and react.
Danish: Spørg din læge til råds, før du fører motorkøretøj og betjener maskiner, da Mysimba kan gøre dig svimmel og søvnig, hvilket kan svække din evne til at koncentrere dig og reagere.
English: The tablets should preferably be taken with food.
Danish: Tabletterne skal helst tages sammen med mad.
English: Naltrexone
Danish: Naltrexon
English: However, studies on abuse liability in humans and extensive clinical experience show that bupropion has low abuse potential.
Danish: Undersøgelser af misbrugsansvar hos mennesker og omfattende klinisk erfaring viser imidlertid, at bupropion har et lavt misbrugspotentiale.
English: The enzyme responsible for the main elimination pathway is not known.
Danish: Enzymet, der er ansvarlig for den primære udskillelsesvej, er ikke kendt.
English: Treatment was initiated with a dose escalation period.
Danish: Behandlingen blev indledt med en dosisøgningsperiode.
English: Based on its half-life, 6-beta-naltrexol is estimated to reach steady state concentrations in approximately 3 days.
Danish: Baseret på dets halveringstid anslås 6-beta-naltrexol at nå steady state koncentrationer på cirka 3 dage.
English: • excessive use of alcohol or addiction to cocaine or stimulants
Danish: • overdreven brug af alkohol eller afhængighed af kokain eller stimulanser
English: This suggests that the hepatic findings in laboratory animals have only limited importance in the evaluation and risk assessment of bupropion.
Danish: Dette antyder, at de hepatiske fund i forsøgsdyr kun har begrænset betydning i evalueringen og risikovurderingen af bupropion.
English: Do not stop taking Mysimba without talking to your doctor first.
Danish: Du må ikke stoppe med at tage Mysimba uden at tale med lægen først.
English: Prior to launch of Mysimba in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the prescriber guide with the National Competent Authority.
Danish: Før markedsføring af Mysimba i hver medlemsstat skal indehaveren af markedsføringstilladelsen (MAH) erklære sig enig om indholdet og formatet af den ordinerende lægevejledning med den nationale kompetente myndighed.
English: INFORMATION IN BRAILLE mysimba
Danish: INFORMATION I BRAILLE-SKRIFT mysimba
English: If you take too many tablets, you may be more likely to have a fit or other side effects similar to those described in section 4 below.
Danish: Hvis du tager for mange tabletter, kan du være mere tilbøjelige til at få et anfald eller andre bivirkninger svarende til dem, der er beskrevet i punkt 4 nedenfor.
English: OCT2 substrates
Danish: OCT2-substrater
English: * P-value <0.05 (nominal values) compared to placebo group.
Danish: * P-værdi <0,05 (nominel værdi) sammenlignet med placebogruppen.
English: Your doctor may test your blood before initiating treatment with Mysimba if you have high blood sugar (diabetes) or if you are older than 65, so that your doctor can decide if you should take this medicine or if you need to take a different dose.
Danish: Din læge vil muligvis teste dit blod, før du starter behandling med Mysimba, hvis du har højt blodsukker (sukkersyge) eller hvis du er ældre end 65, så lægen kan beslutte, om du skal tage dette lægemiddel, eller hvis du bliver nødt til at tage en anden dosis.
English: Mysimba has been shown to cause fits (seizures) in up to 1 in 1,000 patients (see also section 4).
Danish: Mysimba har vist sig at forårsage anfald (krampeanfald) i op til 1 ud af 1.000 patienter (se også punkt 4).
English: There is an increased incidence of gastrointestinal disorders with higher age categories.
Danish: Der er en øget forekomst af gastrointestinale lidelser hos højere aldersgrupper.
English: Patients should be advised to notify their prescribing physician if they experience these symptoms.
Danish: Patienter bør rådes til at kontakte deres læge, hvis de får disse symptomer.
English: There were no cases of seizures in the placebo group.
Danish: Der var ingen tilfælde af krampeanfald i placebogruppen.
English: Similarly, efavirenz 600 mg once daily for two weeks reduced the exposure of bupropion by approximately 55% in healthy volunteers.
Danish: Tilsvarende nedsatte efavirenz 600 mg én gang dagligt i to uger eksponering af bupropion med ca. 55 % hos raske frivillige.
English: Activated charcoal should be administered.
Danish: Der bør tildeles aktivt kul.
English: Mysimba is available in packs containing 28 or 112 tablets.
Danish: Mysimba er tilgængelige i pakninger, der indeholder 28, 112 tabletter.
English: Fits are more likely if you take too much, if you take some other medicines or if you are at a higher than usual risk of fits (see section 2).
Danish: Der er større sandsynlighed for anfald, hvis du tager for meget, hvis du tager anden medicin, eller hvis du har en højere end normal risiko for anfald (se punkt 2).
English: • Patients with a current or previous diagnosis of bulimia or anorexia nervosa
Danish: • Patienter med en nuværende eller tidligere diagnose på bulimi eller anorexia nervosa
English: The frequencies of adverse reactions are ranked according to the following: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppigheden af bivirkninger er opstillet i henhold til følgende: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Acne, Erythema multiforme and Stevens Johnson syndrome
Danish: Acne, erythema multiforme og StevensJohnsons syndrom
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2015
Danish: Dato for første markedsføringstilladelse: 26 marts 2015
English: Faecal excretion is a minor elimination pathway.
Danish: Fækal udskillelse er en mindre eliminationsvej.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne arvelige tilstande såsom galactose-intolerance, total laktase-mangel eller glucose-galactose-malabsorption bør ikke tage dette lægemiddel.
English: This medicine is for oral use.
Danish: Denne medicin er til oral brug.
English: The maximum recommended daily dose of Mysimba is two tablets taken twice a day.
Danish: Den maksimale anbefalede daglige dosis af Mysimba er to tabletter, der tages to gange om dagen.
English: Based on studies in animals, it is recommended that seizures be treated with intravenous benzodiazepine administration and other supportive measures, as appropriate.
Danish: Baseret på undersøgelser hos dyr, så anbefales det, at anfald behandles med intravenøs benzodiazepin-tildeling og andre relevante støtteforanstaltninger.
English: Skip the missed dose and take your next dose at the next usual time.
Danish: Spring den glemte dosis over og tag din næste dosis på det sædvanlige tidspunkt.
English: • if you are currently dependent on or addicted to cocaine or other stimulating products;
Danish: • hvis du i øjeblikket er afhængig af kokain eller andre stimulerende midler;
English: Not known - frequency cannot be estimated from the available data in people taking Mysimba.
Danish: Ikke kendt - hyppigheden kan ikke estimeres ud fra de forhåndenværende data hos personer, der tager Mysimba.
English: 6.6 Special precautions for disposal No special requirements.
Danish: 6.6 Regler for bortskaffelse Ingen særlige forholdsregler.
English: You must have stopped taking any opiate medicines at least 7-10 days before starting Mysimba.
Danish: Du skal være stoppet med at tage nogen form for opiat-lægemidler mindst 7-10 dage før du begynder at tage Mysimba.
English: There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Mysimba.
Danish: Der har været rapporter om depression, selvmordstanker og selvmordsforsøg i løbet af behandling med Mysimba.
English: • Ticlopidine or clopidogrel, mainly used in the treatment of heart disease or stroke;
Danish: • Ticlopidin eller clopidogrel, hovedsagelig til behandling af hjertesygdomme eller slagtilfælde
English: • you have a history of mania (feeling elated or over-excited, which causes unusual behaviour).
Danish: • du har en sygehistorik med mani (følelse af at være opstemt eller eksalteret, som forårsager usædvanlig opførsel).
English: Metabolites of bupropion (and to a lesser extent unmetabolised bupropion) accumulate and reach steady state concentrations in approximately one week.
Danish: Metabolitter af bupropion (og i mindre grad umetaboliseret bupropion) akkumulerer og når steady state koncentrationer inden for ca. en uge.
English: CI, Confidence Interval; LS, Least Squares.
Danish: CI, konfidensinterval; LS, mindste kvadraters metode.
English: The metabolic pathway responsible for the formation of erythrohydrobupropion is unknown.
Danish: Den metaboliske pathway, der er ansvarlig for dannelsen af erythrohydrobupropion, er ukendt.
English: Uncommon Oral herpes (N), Tinea pedis (N)
Danish: Oral herpes (N), tinea pedis (N)
English: • if you are taking medicines that may increase the risk of fits (see “Other medicines and
Danish: • hvis du tager medicin, der kan øge risikoen for anfald (se “Brug af anden medicin sammen med
English: EU/1/14/988/002 28 tablets
Danish: EU/1/14/988/002 28 tabletter
English: In contrast, formation of threohydrobupropion has been reported in the literature to be mediated by 11-beta-hydroxysteroid dehydrogenase 1.
Danish: I modsætning hertil er dannelsen af threohydrobupropion blevet rapporteret i litteraturen til at være medieret af 11-beta-hydroxysteroid dehydrogenase 1.
English: Symptoms of a fit include convulsions and usually loss of consciousness.
Danish: Symptomer på et anfald omfatter kramper og som regel tab af bevidsthed.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Danish: Patienter (og nærmeste pårørende) bør gøres opmærksom på behovet for overvågning af enhver klinisk forværring, selvmordsadfærd eller -tanker samt unormale ændringer i adfærd og at straks søge lægelig rådgivning, hvis disse symptomer viser sig.
English: As NB is a fixed combination of two active ingredients, in addition to the terms listed in Table 1, additional adverse reactions seen with one of the active substances may potentially occur.
Danish: Da NB er en fast kombination af to aktive stoffer, kan der, udover de i tabel 1 anførte termer, forekomme yderligere bivirkninger, som det er set med ét af de aktive stoffer.
English: Mysimba with alcohol
Danish: Brug af Mysimba sammen med alkohol
English: In the combined Phase 3 studies, the mean age was 46 years, 83% were female, and 77% were White, 18% were Black and 5% were other races.
Danish: I de kombinerede fase 3-undersøgelser var den gennemsnitlige alder 46 år, 83 % var kvinder og 77 % var hvide, 18 % var sorte og 5 % var andre racer.