FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/447/001 EU/1/08/447/002 EU/1/08/447/005 EU/1/08/447/006 EU/1/08/447/007 EU/1/08/447/008 EU/1/08/447/013 EU/1/08/447/014 EU/1/08/447/015
Danish: EU/1/08/447/001 EU/1/08/447/002 EU/1/08/447/005 EU/1/08/447/006 EU/1/08/447/007 EU/1/08/447/008 EU/1/08/447/013 EU/1/08/447/014 EU/1/08/447/015 EU/1/08/447/016 EU/1/08/447/017 EU/1/08/447/018
English: Rare reports of serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience.
Danish: Der foreligger rapporter efter markedsføringen om sjældne alvorlige allergiske reaktioner eller overfølsomhedsreaktioner, der inkluderer livstruende tilfælde af Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og akutte anafylaktiske reaktioner/shock.
English: Seven hundred sixty (760) patients were randomized: ADENURIC 80 mg QD (n=256), ADENURIC 120 mg QD (n=251), or allopurinol 300 mg QD (n=253).
Danish: Der blev randomiseret 760 patienter: ADENURIC 80 mg en gang dagligt (n=256), ADENURIC 120 mg en gang dagligt (n=251) eller allopurinol 300 mg en gang dagligt (n=253).
English: Allopurinol 100 mg QD1
Danish: Allopurinol 300 /100 mg en gang dagligt1
English: EU/1/08/447/001 28 film-coated tablets EU/1/08/447/002 84 film-coated tablets EU/1/08/447/005 14 film-coated tablets EU/1/08/447/006 42 film-coated tablets EU/1/08/447/007 56 film-coated tablets EU/1/08/447/008 98 film-coated tablets EU/1/08/447/013 14 film-coated tablets EU/1/08/447/014 28 film-coated tablets EU/1/08/447/015 42 film-coated tablets EU/1/08/447/016 56 film-coated tablets EU/1/08/447/017 84 film-coated tablets EU/1/08/447/018 98 film-coated tablets
Danish: EU/1/08/447/001 28 filmovertrukne tabletter EU/1/08/447/002 84 filmovertrukne tabletter EU/1/08/447/005 14 filmovertrukne tabletter EU/1/08/447/006 42 filmovertrukne tabletter EU/1/08/447/007 56 filmovertrukne tabletter EU/1/08/447/008 98 filmovertrukne tabletter EU/1/08/447/013 14 filmovertrukne tabletter EU/1/08/447/014 28 filmovertrukne tabletter EU/1/08/447/015 42 filmovertrukne tabletter EU/1/08/447/016 56 filmovertrukne tabletter EU/1/08/447/017 84 filmovertrukne tabletter EU/1/08/447/018 98 filmovertrukne tabletter
English: Two thousand and two hundred-sixty nine (2269) patients were randomized: ADENURIC 40 mg QD (n=757), ADENURIC 80 mg QD (n=756), or allopurinol 300/200 mg QD (n=756).
Danish: 2.269 (totusindtohundredeogniogtres) patienter blev randomiseret til: ADENURIC 40 mg en gang dagligt (n=757), ADENURIC 80 mg en gang dagligt (n=756) eller allopurinol 300/200 mg en gang dagligt (n=756).
English: • high fever in combination with measles-like skin rash, enlarged lymph nodes, liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood (leukocytosis, with or without eosinophilia)
Danish: • høj feber kombineret med mæslingelignende udslæt, forstørrede lymfekirtler, forstørrelse af leveren, leverbetændelse (op til leversvigt), forhøjet antal hvide blodlegemer i blodet
English: EU/1/08/447/003 28 film-coated tablets EU/1/08/447/004 84 film-coated tablets EU/1/08/447/009 14 film-coated tablets EU/1/08/447/010 42 film-coated tablets EU/1/08/447/011 56 film-coated tablets EU/1/08/447/012 98 film-coated tablets EU/1/08/447/019 14 film-coated tablets EU/1/08/447/020 28 film-coated tablets EU/1/08/447/021 42 film-coated tablets EU/1/08/447/022 56 film-coated tablets EU/1/08/447/023 84 film-coated tablets EU/1/08/447/024 98 film-coated tablets
Danish: EU/1/08/447/003 28 filmovertrukne tabletter EU/1/08/447/004 84 filmovertrukne tabletter EU/1/08/447/009 14 filmovertrukne tabletter EU/1/08/447/010 42 filmovertrukne tabletter EU/1/08/447/011 56 filmovertrukne tabletter EU/1/08/447/012 98 filmovertrukne tabletter EU/1/08/447/019 14 filmovertrukne tabletter EU/1/08/447/020 28 filmovertrukne tabletter EU/1/08/447/021 42 filmovertrukne tabletter EU/1/08/447/022 56 filmovertrukne tabletter EU/1/08/447/023 84 filmovertrukne tabletter EU/1/08/447/024 98 filmovertrukne tabletter
English: In the post registrational CARES trial (see section 5.1 for detailed characteristics of the study) the rate of MACE events was similar in febuxostat versus allopurinol treated patients (HR 1.03; 95% CI 0.871.23), but a higher rate of cardiovascular deaths was observed (4.3% vs. 3.2% of patients; HR 1.34; 95% CI 1.03-1.73).
Danish: 5.1 for detaljer om forsøget) svarede antallet af alvorlige kardiovaskulære hændelser (MACE) for febuxostat til det for patienter behandlet med allopurinol (HR 1,03; 95 % CI: 0,87-1,23), men der blev observeret et højere antal kardiovaskulære dødsfald (4,3% vs. 3,2 % af patienterne; HR 1,34; 95 % CI: 1,03-1,73).
English: If you miss a dose of ADENURIC take it as soon as you remember unless it is almost time for your next dose, in which case miss out the forgotten dose and take your next dose at the normal time.
Danish: Hvis De snart skal tage den næste dosis, så spring den glemte dosis over.
English: Apex study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for gout flare compared to febuxostat 80 mg (28%), allopurinol 300 mg (23%) and placebo (20%).
Danish: APEX-studiet: I løbet af de 8 ugers profylaktisk behandling måtte en større andel af deltagerne i behandlingsgruppen, der fik febuxostat 120 mg (36 %), behandles for udbrud af arthritis urica sammenlignet med grupperne, der fik febuxostat 80 mg (28 %), allopurinol 300 mg (23 %) eller placebo (20 %).
English: 6.0 mg/dL at the final visit) for patients with a baseline serum urate level of ≥ 10 mg/dL treated with febuxostat 40 mg QD was 27% (66/249), with febuxostat 80 mg QD 49% (125/254) and with allopurinol 300 mg/200 mg QD 31% (72/230), respectively.
Danish: I CONFIRMS-studiet var andelen af patienter med serumuratniveau ved baseline på ≥ 595 µmol/l (10 mg/dl), der opnåede det primære effektmål (serumurat < 357 µmol/l (6,0 mg/dl) ved det sidste besøg), 27 % (66/249) ved behandling med febuxostat 40 mg en gang dagligt, 49 % (125/254) med febuxostat 80 mg en gang dagligt og 31 % (72/230) med allopurinol 300 mg/200 mg en gang dagligt.
English: Primary endpoint in the sub group of patients with sUA ≥ 10 mg/dL Approximately 40% of patients (combined APEX and FACT) had a baseline sUA of ≥ 10 mg/dL.
Danish: Cirka 40 % af patienterne (kombineret APEX og FACT) havde et serumurinsyreniveau ved baseline på ≥ 595 µmol/l (10 mg/dl).
English: • dizziness, numbness, tingling, reduced or altered sensation (hypoesthesia, hemiparesis or paraesthesia), altered sense of taste, diminished sense of smell (hyposmia)
Danish: • svimmelhed, følelsesløshed, prikkende fornemmelse, nedsat eller ændret følefornemmelse
English: Rare serious hypersensitivity reactions to febuxostat, including Stevens-Johnson Syndrome, Toxic epidermal necrolysis and anaphylactic reaction/shock, have occurred in the post-marketing experience.
Danish: Efter markedsføringen er der forekommet sjældne tilfælde af alvorlige overfølsomhedsreaktioner på febuxostat inklusive Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og anafylaksi/shock.
English: ADENURIC 120 mg tablets Febuxostat
Danish: ADENURIC 120 mg tabletter Febuxostatum2.
English: The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Danish: Tabletten har kun delekærv for at muliggøre deling af tabletten, så den er nemmere at sluge.
English: Blood glucose increased, activated partial thromboplastin time prolonged, red blood cell count decrease, blood alkaline phosphatase increase, blood creatine phosphokinase increase* * Adverse reactions coming from post-marketing experience ** Treatment-emergent non-infective diarrhoea and abnormal liver function tests in the combined Phase 3 studies are more frequent in patients concomitantly treated with colchicine.
Danish: Forhøjet blodglucose, forlænget aktiveret partiel tromboplastintid, nedsat erytrocyttal, forhøjet basisk fosfatase, forhøjet kreatinfosfokinase i blodet* * Bivirkninger rapporteret efter markedsføringen.
English: FACT study: During the 8-week prophylaxis period, a greater proportion of subjects in the febuxostat 120 mg (36%) treatment group required treatment for a gout flare compared to both the febuxostat 80 mg (22%) and allopurinol 300 mg (21%) treatment groups.
Danish: FACT-studiet: I løbet af de 8 uger med profylaktisk behandling måtte en større andel af deltagerne i behandlingsgruppen, der fik febuxostat 120 mg (36 %), behandles for et udbrud af arthritis urica, sammenlignet med grupperne, der fik febuxostat 80 mg (22 %) eller allopurinol 300 mg (21 %).
English: How to take ADENURIC
Danish: Sådan skal De tage ADENURIC
English: Febuxostat
Danish: Luftveje
English: If you have been told that you have an intolerance to some sugars contact your doctor before taking this medicine.
Danish: Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter.
English: ADENURIC 80 mg tablets Febuxostat
Danish: ADENURIC 80 mg tabletter Febuxostatum2.
English: • reddening of the skin (erythema), rash in various types (e.g. itchy, with white spots, with blisters, with blisters containing pus, with shedding of the skin, measles-like rash), widespread erythema, necrosis, and bullous detachment of the epidermis and mucous membranes, resulting in exfoliation and possible sepsis (Stevens-Johnson Syndrome/Toxic epidermal necrolysis)
Danish: • rødme af huden (erytem), forskellige former for udslæt (f.eks. kløende, med hvide pletter, med blærer, med betændte blærer, med afskalning eller mæslingelignende), udbredt rødme af huden,
English: ADENURIC 120 mg film-coated tablets Febuxostat
Danish: ADENURIC 120 mg filmovertrukne tabletter Febuxostatum2.
English: 1 results from subjects receiving either 100 mg QD (n=10: patients with serum creatinine >1.5 and ≤2.0 mg/dL) or 300 mg QD (n=509) were pooled for analyses.
Danish: patienter med serumkreatinin >90 µmol/l (1,5 mg/dl) og 119 µmol/l (2,0 mg/dl)) eller 300 mg en gang dagligt (n=509) var poolet til analyserne.
English: ADENURIC 240 mg
Danish: ADENURIC 120 mg ADENURIC 240 mg
English: ADENURIC 80 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN ADENURIC 80 mg filmovertrukne tabletter
English: ADENURIC 120 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN ADENURIC 120 mg filmovertrukne tabletter
English: ADENURIC 80 mg film-coated tablets Febuxostat
Danish: ADENURIC 80 mg filmovertrukne tabletter Febuxostatum2.
English: There have been rare reports of potentially life-threatening skin rashes (Stevens-Johnson Syndrome) with the use of ADENURIC, appearing initially as reddish target-like spots or circular patches often with central blister on the trunk.
Danish: Der er i forbindelse med brug af ADENURIC i sjældne tilfælde indberettet udslæt, som kan være livstruende (Stevens-Johnsons syndrom).
English: Package leaflet: Information for the user ADENURIC 80 mg film-coated tablets ADENURIC 120 mg film-coated tablets
Danish: ADENURIC 80 mg filmovertrukne tabletter ADENURIC 120 mg filmovertrukne tabletter Febuxostat
English: Hepato-biliary disorders
Danish: alopeci hyperhidrose
English: Liver function abnormalities** Uncommon
Danish: Almindelige Leverfunktionsforstyrrelser**
English: Table 2 Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 µmol/L)
Danish: Primært endepunkt i undergruppen af patienter med serumurinsyre ≥ 595 µmol/l (10 mg/dl)
English: The patient should be monitored and treated appropriately.
Danish: Patienten skal monitoreres og behandles på passende vis.
English: Weight management and additional risk factors
Danish: Vægtstyring og yderligere risikofaktorer
English: - You are advised to share the information in this leaflet with relatives or other relevant persons.
Danish: - De anbefales at dele oplysningerne i denne indlægsseddel med pårørende eller andre relevante personer.
English: There are no adequate or well-controlled studies in pregnant women.
Danish: Der er ingen tilstrækkelige eller velkontrollerede forsøg med gravide.
English: Effect of food:
Danish: Effekt af mad:
English: An updated risk management plan should be provided as per the CHMP guideline on risk management systems for medicinal products for human use.
Danish: Et opdateret risk management plan, skal forefindes som beskrevet i CHMP guideline on risk management systems for medicinal products for human use.
English: ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
Danish: ACOMPLIA er ikke anbefalet til brug hos børn under 18 år p.g.a. mangel på data vedrørende effekt og sikkerhed.
English: Difference (CI 95%)
Danish: Forskel (CI 95 %)
English: in people under 18 years of age.
Danish: ACOMPLIA til personer under 18 år
English: In total more than 6800 patients were included in the Phase 2 and Phase 3 clinical studies.
Danish: I alt blev mere end 6800 patienter inkluderet i fase 2 og fase 3 kliniske forsøg.
English: Patients should be instructed not to increase their dose of ACOMPLIA.
Danish: Patienter bør instrueres i ikke at forøge dosis af ACOMPLIA.
English: Signs and symptoms associated with depression could be:
Danish: Tegn og symptomer i forbindelse med depression kan være:
English: The potential relevance of this to administration of a CB1 antagonist is unknown.
Danish: Den potentielle relevans af dette i forhold til administration af CB1 antagonister er ukendt.
English: Approximately 80% of the population were women, 87% Caucasian and 9% Black.
Danish: Cirka 80 % af populationen var kvinder, 87 % kaukasier og 9 % negroide.
English: Weight at baseline (kg)
Danish: Vægt ved baseline (kg)
English: Although maternal toxicity was observed at these doses, a relation to treatment cannot be excluded.
Danish: Selvom maternal toksicitet blev observeret ved disse doser, kan en relation til behandlingen ikke udelukkes.
English: Monitoring of blood glucose level is recommended in these patients.
Danish: Det anbefales at monitorere blodsukkerniveauet hos disse patienter.
English: Steady state rimonabant exposures are 3.3-fold higher than those observed after the first dose.
Danish: Steady state rimonabant eksponering er 3,3 gange højere end det observerede efter første dosis.
English: The effects on body weight appeared to be consistent among men and women.
Danish: Effekten på kropsvægt synes at være den samme for mænd og kvinder.
English: Changes in HDL-C and TG in this population were similar to that of the non-diabetic population.
Danish: Ændringer i HDL-C og TG i denne population svarede til dem i ikke-diabetespopulationen.
English: INFORMATION IN BRAILLE ACOMPLIA
Danish: INFORMATION I BRAILLE-SKRIFT ACOMPLIA
English: Generally ACOMPLIA 20 mg had no significant effect on Total-C or LDL-C levels.
Danish: ACOMPLIA 20 mg havde generelt ingen signifikant effekt på Total-C eller LDL-C niveauer.
English: Table 1: System Organ Class
Danish: Tabel 1: Organ-klasse system Meget almindelig Almindelig
English: Obesity is a condition that can be associated with depressive disorders.
Danish: Fedme er en tilstand, som kan associeres med depressive sygdomme.
English: Your doctor should recommend the type of diet and the level of physical activity required, that suits your specific condition and overall health.
Danish: Deres læge bør anbefale typen af diæt og den fysiske aktivitet, som passer til Deres specifikke kondition og helbred.
English: Most of the observed weight reduction was obtained within the first nine months of treatment.
Danish: Det meste af den observerede vægtreduktion blev set inden for de første 9 måneders behandling.
English: ACOMPLIA should not be taken during pregnancy.
Danish: ACOMPLIA bør ikke anvendes under graviditet.
English: Classification of expected frequencies of undesirable effects:
Danish: Klassifikation af forventede frekvenser af bivirkninger:
English: Use in pregnancy is, therefore, not recommended.
Danish: Anvendelse under graviditet anbefales derfor ikke.
English: A proconvulsant activity of rimonabant was found in one of two safety pharmacology studies.
Danish: En proconvulsant aktivitet af rimonabant blev fundet i et ud af to safety farmakologiforsøg.
English: The difference in half-life was due to differences in peripheral volume of distribution as a consequence of lower weight in Japanese subjects.
Danish: Forskellen i halveringstiden skyldtes forskellen i det perifere distributionsvolume som konsekvens af lavere vægt hos japanske personer.
English: In some, but not all cases, initiation of convulsions appeared to be associated with procedural stress such as handling of the animals.
Danish: I nogle men ikke alle tilfælde synes initieringen af kramper at være associeret med stress under proceduren, såsom håndtering af dyrene.
English: The patients included in the phase 3 trials followed a restrictive diet during the trial prescribed by a dietician and they were advised to increase their physical activity.
Danish: Patienterne inkluderet i fase 3 forsøgene fulgte en restriktiv diæt under forsøget ordineret af en diætist og de blev rådet til at forøge deres fysiske aktivitet.
English: Very common (≥10%); Common (≥1, <10%); Uncommon (≥0.1, <1%); Rare (≥0.01, <0.1%); Very rare (<0.01%), Not known (cannot be estimated from the available data).
Danish: Meget almindelig (≥ 10 %); Almindelig (≥ 1, < 10 %); Usædvanlig (≥ 0,1, < 1 %); Sjælden (≥ 0,01, < 0,1 %); Meget sjælden (< 0,01 %), ikke kendt (kan ikke estimeres ud fra de forhåndenværende data).
English: Experience in patients over 75 years and Orientals/Asians was limited.
Danish: Erfaring med patienter over 75 år og orientalere/asiater er begrænset.
English: There is no information available on the use of ACOMPLIA
Danish: Der er ingen information tilgængelig vedrørende anvendelse af
English: The in vitro human plasma protein binding of rimonabant is high (> 99.9%) and non-saturable over a wide concentration range.
Danish: In vitro human plasmaproteinbinding af rimonabant er høj (> 99,9 %) og ikke-mættet over et stort koncentrationsområde.
English: Patients should notify their physician if they become pregnant during treatment with ACOMPLIA.
Danish: Patienter bør informere deres læge, hvis de bliver gravide under behandling med ACOMPLIA.
English: The treatment should be introduced with a mildly reduced calorie diet.
Danish: Behandlingen bør introduceres med en lettere reduceret kaloriediæt.
English: These included headache, euphoria, fatigue and insomnia.
Danish: Disse inkluderede hovedpine, eufori, træthed og insomnia.
English: No conclusions can be drawn with regard to effects in patients over 75 years or in Asian/Oriental patients due to the low number of patients.
Danish: Der kan ikke drages nogle konklusioner vedrørende effekt for patienter over 75 år eller for asiater/orientalere p.g.a. af det lave antal patienter.
English: Elderly patients have slightly higher exposure than young patients.
Danish: Ældre patienter har lidt højere optagelse end unge patienter.
English: It is not known if rimonabant is excreted in human milk.
Danish: Det vides ikke, om rimonabant udskilles i human mælk.
English: Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself.
Danish: Depressive tilstande kan forekomme hos patienter, som ikke har nogen åbenlyse risikofaktorer, bortset fra fedme.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: De bør konsultere Deres læge eller apotek, hvis De er usikker.
English: Black patients may have up to a 31% lower Cmax and a 43% lower AUC than patients of other races.
Danish: Negroide patienter kan have op til 31 % lavere Cmax og 43 % lavere AUC end patienter af anden race.
English: Rimonabant 20 mg reduced the risk of weight regain.
Danish: Rimonabant 20 mg reducerede risikoen for vægtforøgelse.
English: No convulsions were observed in dogs during a 3 month study.
Danish: Der blev ikke observeret kramper hos hunde under et 3 måneders forsøg.
English: Time to steady state is longer in obese patients (25 days) as a consequence of the higher volume of distribution in these patients.
Danish: Tiden til steady state er længere hos obese patienter (25 dage) som en konsekvens af det højere distributionsvolumen i disse patienter.
English: Circulating metabolites do not contribute to its pharmacologic activity.
Danish: Cirkulerende metabolitter bidrager ikke til den farmakologiske aktivitet.
English: WHAT ACOMPLIA IS AND WHAT IT IS USED FOR
Danish: ACOMPLIAS VIRKNING, OG HVAD DE SKAL BRUGE DET TIL
English: (See section 4.3 and 4.8).
Danish: 4.3 og 4.8).
English: EXPIRY DATE EXP {MM/YYYY}
Danish: UDLØBSDATO EXP {MM/YYYY}
English: Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking ACOMPLIA.
Danish: Kontakt straks Deres læge hvis De bliver gravid, hvis De har formodning om, at De er gravid eller planlægger at blive gravid, mens De anvender ACOMPLIA.
English: Ongoing major depressive illness and/or ongoing antidepressive treatment (see section 4.4)
Danish: Eksisterende major depressiv sygdom og/eller igangværende antidepressiv behandling (se pkt.
English: In obese patients, the elimination half-life is longer (about 16 days) than in non-obese patients (about 9 days) due to a larger volume of distribution.
Danish: I obese patienter er eliminationshalveringstiden længere (ca.16 dage) end i ikke-obese patienter (ca. 9 dage) p.g.a. af et højere distributionsvolume.
English: Based on a population pharmacokinetic analysis (age range 18 - 81 years) a 75 year old patient is estimated to have a 21% higher Cmax and a 27% higher AUC than a 40 year old patient.
Danish: Baseret på farmakokinetiske populationsanalyser (alder fra 18-81 år), er en 75-årig patient estimeret til at have en 21 % højere Cmax og en 27 % højere AUC end en 40-årig patient.
English: The apparent peripheral volume of distribution of rimonabant appears to be related to body weight, with obese patients having a higher volume of distribution than normal-weight subjects.
Danish: Det tilsyneladende perifere distributionsvolume for rimonabant synes at være relateret til kropsvægt, hvor obese patienter har et højere distributionsvolume end personer med normal vægt.
English: As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% and Ctrough is expected to increase by 5%.
Danish: Som vægten forøges fra 65 kg til 200 kg, forventes Cmax at falde 24 % og Cmin forventes at forøges med 5 %.
English: The safety and efficacy of rimonabant have not been evaluated beyond 2 years.
Danish: Sikkerhed og effekt af rimonabant er ikke undersøgt ud over 2 år.
English: In postmarketing experience, more than half of the patients who develop such reactions appear to do so within 1 month of starting treatment, approximately 80% appear to do so within 3 months.
Danish: Erfaring efter markedsføring viser at mere en halvdelen af de patienter, som får disse reaktioner, får dem inden for en måned efter start af behandling, mere end 80% inden for de 3 første måneder.
English: If you experience symptoms of depression (see below) during treatment with ACOMPLIA you should contact your doctor and stop the treatment.
Danish: Hvis De oplever depressive symptomer (se nedenfor) under behandling med ACOMPLIA, bør De kontakte Deres læge og stoppe behandlingen.
English: Pharmaco-therapeutic group: Anti obesity agent ATC code: A08AX01
Danish: Farmakoterapeutisk klassifikation: Antiobesitas middel ATC-kode: A08AX01
English: Patients, especially those with a history of depressive disorders/mood alterations, (and relatives or other relevant persons) should be alerted about the need to monitor for the emergence of such symptoms and to seek medical advice immediately if these occur.
Danish: Patienter, især dem med depressive sygdomme/humør ændringer i anamnesen, (og pårørende eller andre relevante personer) bør gøres opmærksom på, at det er nødvendigt at monitorere forekomsten af sådanne symptomer og at søge læge øjeblikkeligt, hvis de skulle forekomme.
English: Weight Management
Danish: Vægtstyring