natgillin/translations-raw huggingface dataset:
UDLØBSDATO EXP {MM/YYYY}
EXPIRY DATE EXP {MM/YYYY}
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.
Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant while taking ACOMPLIA.
Eksisterende major depressiv sygdom og/eller igangværende antidepressiv behandling (se pkt.
Ongoing major depressive illness and/or ongoing antidepressive treatment (see section 4.4)
I obese patienter er eliminationshalveringstiden længere (ca.16 dage) end i ikke-obese patienter (ca. 9 dage) p.g.a. af et højere distributionsvolume.
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.
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.
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.
Det tilsyneladende perifere distributionsvolume for rimonabant synes at være relateret til kropsvægt, hvor obese patienter har et højere distributionsvolume end personer med normal vægt.
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.
Som vægten forøges fra 65 kg til 200 kg, forventes Cmax at falde 24 % og Cmin forventes at forøges med 5 %.
As weight increases from 65 to 200 kg, Cmax is expected to decrease 24% and Ctrough is expected to increase by 5%.
Sikkerhed og effekt af rimonabant er ikke undersøgt ud over 2 år.
The safety and efficacy of rimonabant have not been evaluated beyond 2 years.
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.
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.
Hvis De oplever depressive symptomer (se nedenfor) under behandling med ACOMPLIA, bør De kontakte Deres læge og stoppe behandlingen.
If you experience symptoms of depression (see below) during treatment with ACOMPLIA you should contact your doctor and stop the treatment.
Farmakoterapeutisk klassifikation: Antiobesitas middel ATC-kode: A08AX01
Pharmaco-therapeutic group: Anti obesity agent ATC code: A08AX01
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.
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.
Vægtstyring
Weight Management
Kun omkring 3 % af rimonabant-dosis bliver elimineret via urinen, mens omkring 86 % af dosis udskilles i fæces som uomdannet stof og metabolitter.
Only an approximate 3% of the dose of rimonabant is eliminated in the urine, while approximately 86% of the dose is excreted in the faeces as unchanged drug and metabolites.
Hvordan man anvender ACOMPLIA sammen med mad og drikkevarer ACOMPLIA bør tages en gang dagligt om morgenen før morgenmaden.
Taking ACOMPLIA with food and drink ACOMPLIA should be taken once daily in the morning before breakfast.
Bivirkninger, som ikke blev observeret i kliniske forsøg, men som blev set i dyr ved udsættelse for niveauer svarende til kliniske niveauer og med mulig relevans for klinisk brug, var som følger:
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Procentdelen af patienter, som opnåede HbA1c < 7 ,% var 51 % i rimonabant-gruppen og 35 % i placebo-gruppen.
The percentage of patients reaching HbA1c < 7% was 51% in the rimonabant group and 35% in the placebo group.
Begrænsede data antyder en forøget optagelse hos patienter med moderat nedsat nyrefunktion (40 % forøgelse i AUC).
Limited data suggest an increased exposure in patients with moderate renal impairment (40% increase in AUC).
Depressive sygdomme kan associeres med en øget risiko for at gøre skade på sig selv, selvmordstanker og selvmord.
Depressive disorders can be associated with an increased risk of suicidal thoughts, self harm and suicide.
Vigtig information om nogle af de øvrige indholdsstoffer i ACOMPLIA ACOMPLIA indeholder laktose.
Important information about some of the ingredients of ACOMPLIA ACOMPLIA tablets include lactose.
Tag tabletten så snart De husker det, men De må ikke tage en dobbeltdosis som erstatning for en glemt tablet.
If you forget to take ACOMPLIA Take it as soon as you remember but do not take a double dose to make up for any forgotten dose.
Slaphed/træthed Influenza
Asthenia/fatigue Influenza
Administration af rimonabant til sunde fastende personer eller med et meget fedt måltid, viste at Cmax og AUC forøgedes henholdsvis 67 % og 48 % ved fedt måltid.
Administration of rimonabant to healthy subjects in the fasted state or with a high fat meal demonstrated that Cmax and AUC were increased 67% and 48% respectively, under fed conditions.
De bør informere Deres læge, hvis nogen af ovenstående symptomer opstår, eller bliver værre efter behandlingen ar startet.
You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Indehaver af markedsføringstilladelsen skal sikre at pharmacovigilancesystemet er til stde og fungerer før produktet markedføres.
The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Effekt og sikkerhed af rimonabant hos patienter over 75 år er ikke tilstrækkeligt fastsat.
The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently been established.
Behandling med rimonabant var associeret med en signifikant reduktion i livsmål, en kendt markør for intra-abdominalt fedt.
Treatment with rimonabant was associated with significant reductions in waist circumference, a known marker of intra-abdominal fat.
• Andre psykiatriske tilstande
• Other psychiatric conditions
Effekten af rimonabant på præ- og postnatal udvikling blev undersøgt i rotter i doser op til 10 mg/kg/dag.
Effects of rimonabant on pre- and post-natal development were assessed in the rat at doses up to 10 mg/kg/day.
* frekvens er kun baseret på rapporter på obese eller overvægtige personer.
Joint sprain *frequency is based only on reports in obese or overweight diabetic patients.
I kliniske forsøg for andre indikationer, blev følgende, yderligere bivirkninger rapporteret som almindelige:
In clinical studies for other indications, the following additional adverse reactions were commonly reported:
Potentiale for rimonabant for påvirkning af andre lægemidler:
Potential for rimonabant to affect other medicinal products:
I enkelt- og gentagen-dosisforsøg var Cmax og AUC for rimonabant ens hos sunde japanske og kaukasiske personer, men eliminationshalveringstiden var kortere hos japanske personer (3-4 dage) sammenlignet med kaukasiske personer (ca. 9 dage).
In single- and repeat-dose studies, the Cmax and AUC of rimonabant were similar in healthy Japanese and Caucasian subjects, whereas elimination half-life was shorter in Japanese subjects (3-4 days) compared to Caucasian subjects (about 9 days).
ACOMPLIA 20 mg var effektiv til at vedligeholde vægttab i op til 2 år.
ACOMPLIA 20 mg was effective in maintaining weight loss up to two years.
Behandling bør bestå af generelle principper anvendt ved behandling af overdosis, såsom at holde luftvejene fri, monitorering af kardiovaskulær funktion og generelle og supportive målinger.
Treatment should consist of the general measures employed in the management of overdoses, such as keeping airways unobstructed, monitoring cardiovascular function and general symptomatic and supportive measures.
Potentialet for hæmning af CYP2C8 in vivo synes at være lavt.
The potential for inhibition of CYP2C8 in vivo appears to be low.
Patienter, der fik ACOMPLIA 20 mg, blev re-randomiseret til at få ACOMPLIA 20 mg eller placebo.
Patients who received ACOMPLIA 20 mg for one year were re-randomized to ACOMPLIA 20 mg or placebo.
Tabel 2
Table 2:
Køn: Rimonabants farmakokinetik er ens i kvindelige og mandlige patienter.
Gender: The pharmacokinetics of rimonabant are similar in female and male patients.
Signifikant middelvægtreduktion fra baseline til et år for ACOMPLIA 20 mg versus placebo blev demonstreret i tre forsøg foretaget med ikke diabetes patienter.
Significant mean weight reductions from baseline to one year for ACOMPLIA 20 mg versus placebo were demonstrated in three studies conducted in non-diabetic patients.
Da ACOMPLIA indeholder laktose, bør patienter med sjældne, arvelige problemer med galaktoseintolerans, Lapp laktasemangel eller glukose-galaktose malabsorption, ikke tage denne medicin.
Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine.
Der er begrænset data hos patienter med moderat nedsat nyrefunktion og ingen data vedrørende patienter med svært nedsat nyrefunktion.
There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment.
Irritabilitet Nervøsitet Søvnforstyrrelser Søvnløshed Parasomni
Irritability Nervousness Sleep disorders Insomnia Parasomnias
Brug ikke ACOMPLIA efter den udløbsdato, der står på pakningen.
Do not use ACOMPLIA after the expiry date which is stated on the outer packaging after EXP.
Rimonabant er en selektiv cannabinoid-1 receptor (CB1) antagonist som hæmmer den farmakologiske effekt af cannabinoid agonister in vitro og in vivo.
Rimonabant is a selective cannabinoid-1 receptor (CB1) antagonist that inhibits the pharmacological effects of cannabinoid agonists in vitro and in vivo.
Sikkerheden for ACOMPLIA 20 mg er blevet undersøgt hos ca. 2500 patienter i forsøg som undersøgte effekten på metabolisme og vægttab hos overvægtige og stærkt overvægtige patienter og hos ca. 3800 patienter i andre indikationer.
ACOMPLIA 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3800 patients in other indications.
Personer med 5 % vægtreduktion
Subjects with a 5% weight reduction
70 x 1 filmovertrukne tabletter i PVC-aluminium perforeret enkeltdosis blisterpakninger.
70 x 1 film-coated tablets in PVC-aluminium perforated unit dose blister packs.
• Diabetes patienter
• Diabetic patients
Efter dosering i en længere behandlingsvarighed før parring (9 uger), som tillod restitution for de initiale påvirkninger af rimonabant, blev der ikke set bivirkninger på fertilitet og østruscyklus.
Following dosing for a longer treatment duration prior to mating (9 weeks) that permitted recovery from the initial effects of rimonabant, no adverse effects were seen on fertility or oestrous cyclicity.
Der kan ikke konkluderes på baggrund af data fra dyr, men de tyder på skadelige virkninger på embryonal/foetal udvikling (se pkt.
Animal data are inconclusive but suggest possible deleterious effects on embryonal/foetal development (see section 5.3).
Vedrørende reproduktive parametre, blev der ikke observeret nogen forskel mellem behandlede og kontroldyr ved 30 mg/kg, ved 60 mg/kg var der stadig observeret effekt (mindre antal af corpora lutea, total implantationsfostre og levedygtige fostre).
Regarding reproductive parameters, at 30 mg/kg no differences were observed between treated animals and controls, at 60 mg/kg effects were still observed (decreased number of corpora lutea, implantations, total and viable fetuses).
Patienterne havde et BMI ≥ 30 kg/m2 eller BMI > 27 kg/m2 med hypertension og/eller dyslipaedimia ved inklusionen.
Patients had a BMI ≥ 30 kg/m² or BMI > 27 kg/m² with hypertension and/or dyslipidemia at inclusion.
I ikke-diabetesforsøgene med en blandet population af personer med/uden (behandlet) dyslipidemia blev en forøgelse i HDL-C og et fald i triglycerider observeret (efter et år).
In the non-diabetic studies including a mixed population of subjects with/without (treated) dyslipidemia, an increase in HDL-C and decrease in triglycerides (at one year) was observed.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu.
• Lægemiddelinteraktion
• Drug Interaction
Erfaring med overdosering af rimonabant er begrænset.
Experience with rimonabant in overdosage is limited.
ACOMPLIAs virkning, og hvad De skal bruge det til Det skal De vide, før De begynder at bruge ACOMPLIA Sådan skal De bruge ACOMPLIA Bivirkninger
What ACOMPLIA is and what it is used for Before you take ACOMPLIA How to take ACOMPLIA Possible side effects
Farmakokinetik og sikkerhed af rimonabant er ikke undersøgt hos patienter med svært nedsat leverfunktion; anvendelse hos disse patienter anbefales ikke.
The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended.
Patienter skal efter start af behandlingen, aktivt monitoreres for tegn og symptomer på psykiske sygdomme, især depression.
Patients should be actively monitored for signs and symptoms of psychiatric disorders, particularly depression following the start of treatment.
Den følgende tabel (Tabel 1) viser alle behandlingsrelaterede bivirkninger fra placebokontrollerede forsøg med patienter, som blev behandlet for vægttab og relaterede metaboliske sygdomme, når forekomsten var statistisk signifikant større end den tilsvarende placebofrekvens (for tilfælde ≥ 1 %) eller når den blev betragtet som klinisk relevant (for tilfælde < 1 %).
The following table (table 1) shows all treatment-emergent adverse reactions from placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events ≥ 1%) or considered clinically relevant (for events < 1%).
På grund af rimonabants effekt på blodsukkerniveauet, kan hypoglykæmi forekomme, når rimonabant gives til diabetes patienter (se afsnit 4.8).
Due to the effect of rimonabant on the blood glucose level, when rimonabant is administered in diabetic patients, hypoglyceamia can occur (see section 4.8).
Patienter som havde haft kardivaskulært event (myokardieinfarkt, hjerteanfald etc.) inden for mindre end 6 måneder, blev ekskluderet i forsøgene med rimonabant.
Patients who had a cardiovascular event (myocardial infarction, stroke, etc.) less than 6 months ago were excluded in the studies for rimonabant.
Potentiale for andre lægemidler for påvirkning af rimonabant:
Potential for other medicinal products to affect rimonabant:
Personer med 10 % vægtreduktion Forskel (CI 95 %)
Subjects with a 10% weight reduction Difference (CI 95%)
Farmakokinetisk populationsanalyse viste mindre udsving i max. til min. plasmakoncentration, men ingen forskel i steady state AUC, som vægten øges.
Population pharmacokinetic analysis demonstrated less fluctuation in peak to trough plasma concentration but no differences in steady state AUC as weight increases.
Ved 2 år havde patienter, der fortsatte på rimonabant, et gennemsnitlig totalt vægttab på 7,5 kg over de 2 år, mens patienter, der blev rerandomiseret til placebogruppen i det andet år, havde et gennemsnitligt totalt vægttab på 3,1 kg over de 2 år.
At two years, patients continuing on rimonabant had a mean total weight loss of 7.5 kg over 2 years whereas patients re-randomized to placebo group during the second year had a mean total weight loss of 3.1 kg over 2 years.
Vægttabet i det begrænsede antal af negroide patienter var mindre udtalt (middelforskel til placebo -2,9 kg).
In the limited number of Black patients weight loss was less pronounced (mean difference to placebo -2.9 kg).
En tilsvarende forøgelse i optagelse er forventet med andre potente CYP3A4-hæmmere.
A similar increase in exposure is expected with other potent CYP3A4 inhibitors.
Den absolutte biotilgængelighed for rimonabant er ikke bestemt.
The absolute bioavailability of rimonabant has not been determined.
Samtidig administration af orlistat, ethanol eller lorazepam havde ingen signifikant effekt på plasmaniveauet af rimonabant.
Concomitant administration of orlistat, ethanol or lorazepam had no significant effect on the plasma levels of rimonabant.
Samtidig administration af ketoconazol (en potent CYP3A4 hæmmer) forøgede AUC for rimonabant med 104 % (95 % confidensinterval: 40 % -197 %).
Concomitant administration of ketoconazole (a potent CYP3A4 inhibitor) increased rimonabant AUC by 104% (95% prediction interval: 40% - 197%).
Rimonabant viser høj in vitro permeabilitet og er ikke et substrat af P-glycoprotein.
Rimonabant displays high in vitro permeability and is not a substrate of P-glycoprotein.
Steady-state farmakokinetikken af ethinyl estradiol/levonorgestrel kombination oralt kontraceptiv blev ikke signifikant ændret ved samtidig administration af rimonabant.
The steady-state pharmacokinetics of an ethinyl estradiol/levonorgestrel combination oral contraceptive were not significantly altered by concomitant administration of rimonabant.
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance or to any of the excipients Lactation.
• Depressive sygdomme
• Depressive disorders
Farmakokinetikken for rimonabant er forholdsvis proportional op til 20 mg. For doser over 20 mg forøgedes AUC mindre end proportionalt.
Rimonabant pharmacokinetics are fairly dose proportional up to about 20 mg. AUC increased less than in proportion to dose above 20 mg.
Kognitive undersøgelser i klinisk farmakologiske forsøg viste, at rimonabant er blottet for kognitiv eller sedativ effekt.
Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of any significant cognitive or sedative effect.
I placebokontrollerede forsøg var frekvensen af afbrudt behandling, pga. bivirkninger, 15,7 % for patienter, der fik rimonabant.
In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7% for patients receiving rimonabant.
Der var en behandlingsrelateret forøgelse i mortaliteten hos rotteungerne inden afvænningsperioden.
There was a treatment related increase in pup mortality in the pre-weaning period.
Depressive sygdomme blev rapporteret hos 3,2 % af obese patienter, eller overvægtige patienter med associerede risikofaktor(er) i behandling med rimonabant 20 mg.
Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg.
Patienter med alvorlig nedsat leverfunktion blev ikke evalueret.
Patients with severe hepatic impairment were not evaluated.
Dette blev bekræftet klinisk med specifikke forsøg med midazolam (CYP3A4 substrat) og warfarin (CYP2C9 substrat) og digoxin (et P-gp substrat).
This was confirmed clinically with specific probe studies using midazolam (CYP 3A4 substrate) and warfarin (CYP 2C9 substrate) and digoxin (a P-gp substrate).
Farmakokinetiske populationsanalyser indikerer, at rimonabants farmakokinetik er den samme for sunde, ikke-rygende personer og patienter som ryger.
Population pharmacokinetic analysis indicated that rimonabant pharmacokinetics are similar between healthy non-smoking subjects and patients who smoke.
Rimonabant har været påvist i mælken fra diegivende rotter og rimonabant kan hæmme sutterefleksen.
Rimonabant has been detected in the milk of lactating rats and rimonabant may inhibit the suckling reflex.
Hos patienter med eksisterende selvmordstanker og/eller med selvmordstanker og depressiv sygdom i anamnesen, bør rimonabant kun anvendes såfremt udbyttet ved behandlingen vurderes at overstige disse risici hos den individuelle patient (se pkt.
In patients with current suicidal ideations and/or with a history of suicidal ideation and depressive disorder rimonabant should not be used unless the benefits of treatment are considered to outweigh these risks in an individual patient.
Den forøgede mortalitet hos rotteungerne kan skyldes fejl i moderdyrets pleje eller indtagelse af rimonabant i mælken og/eller hæmning af sutterefleksen, som er rapporteret i litteraturen, som initieret i neonatale mus via endocannabinoid-signalering via CB1-receptorer.
The increased pup mortality might be attributable to a failure of the dam to nurse or ingestion of rimonabant in milk and/or inhibition of the suckling reflex that is reported in the literature to be initiated in neonatal mice by endocannabinoid signalling via CB1 receptors.
Den kliniske effekt (vægttab) af rimonabant hos negroide er lavere end hos kaukasiere.
The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians.
ACOMPLIA bør anvendes med forsigtighed hos patienter ældre end 75 år (se pkt.
ACOMPLIA should be used with caution in patients over 75 years of age (see section 4.4).
Efter markedsføring
Post-Marketing
I kliniske forsøg blev der ikke set nogen forskel i forekomsten af kramper hos patienter, der fik rimonabant eller placebo.
In clinical trials no difference in the incidence of seizures was seen in patients receiving rimonabant or placebo.
Dog havde rimonabant in vitro en mildt hæmmende effekt på CYP2C8.
However, in vitro, rimonabant had a mild inhibitory effect on CYP2C8.
I et enkeltdosis toleranceforsøg, blev doser på op til 300 mg givet til et begrænset antal forsøgspersoner.
In a single-dose tolerability study, doses up to 300 mg were administered to a limited number of subjects with only minor symptoms reported.
Depressive sygdomme Humørsvingninger med depressive symptomer Angst
Depressive disorders Mood alterations with depressive symptoms Anxiety
Rimonabant bør anvendes med forsigtighed i denne population (se pkt.
Rimonabant should be used with caution in this population (see section 5.2).
Nyrefunktionens effekt på farmakokinetikken af rimonabant er ikke specifikt undersøgt.
The effect of renal function on the pharmacokinetics of rimonabant has not been studied specifically.
14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 70x1 filmovertrukne tabletter 84 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter
14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 70x1 film coated-tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Laboratorie bivirkninger ACOMPLIA har ikke vist påvirkning af laboratorietestværdier.
Laboratory adverse events ACOMPLIA has not been shown to alter laboratory test values.
Ingen behandlingsrelaterede misdannelser blev set i rotter.
No treatment-related malformations were seen in the rat.
20 mg
ACOMPLIA 20 mg
Traumer, forgiftninger og behandlingskomplikatio ner
Injury, Poisoning and procedural complications
Procentdelen af patienter, som tabte 5 % og 10 % af deres kropsvægt ved baseline efter 1 års behandling, er vist i tabel 2.
The percentage of patients who lost 5% and 10% of their baseline body weight after 1 year of treatment are given in the table 2.
Rimonabant er ikke undersøgt hos patienter i behandling for epilepsi.
Rimonabant has not been studied in patients being treated for epilepsy.