FrancophonIA/ELRC3.0 huggingface dataset:
English: You may ask your doctor for advice.
Danish: Du bør spørge din læge til råds.
English: Otherwise, your doctor may think that it was not effective or well tolerated and may change your treatment unnecessarily.
Danish: Din læge kan ellers få den opfattelse, at den ikke er effektiv eller ikke tåles og derfor ændre din behandling unødigt.
English: It has not been demonstrated that the effect on HbA1c is independent from weight reduction.
Danish: Det er ikke vist at effekten på HbA1c er uafhængig af vægtreduktion.
English: Some fatal cases or cases requiring liver transplantation have been reported.
Danish: Der er rapporteret nogle dødelige tilfælde eller tilfælde som krævede levertransplantation
English: • Iodine salts and/or levothyroxine.
Danish: • Jodsalte og/eller levothyroxin.
English: Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours.
Danish: I tilfælde af en signifikant overdosis af orlistat anbefales det, at patienten observeres i 24 timer.
English: This can lead to a decrease of immunosuppressive efficacy.
Danish: Dette kan medføre en reduceret immunosuppressivitet.
English: It is recommended that the diet should be rich in fruit and vegetables.
Danish: Det anbefales, at diæten er rig på frugt og grøntsager.
English: Xenical with food and drink
Danish: Brug af Xenical sammen med mad og drikke
English: Normally, these symptoms disappear if you continue treatment and keep to your recommended diet.
Danish: Normalt forsvinder disse symptomer, hvis du fortsætter behandlingen og holder den anbefalede diæt.
English: Therefore orlistat treatment should only be initiated after careful consideration of the possible impact in these patients.
Danish: Orlistat bør derfor kun opstartes efter nøje overvejelse af, hvilke mulige følgevirkninger behandlingen kan have hos disse patienter.
English: This means you will usually take one capsule at breakfast time, one capsule at lunch time and one capsule at dinner time.
Danish: Dette betyder, at du skal indtage en kapsel til morgenmaden, en kapsel til frokost og en kapsel til aftensmaden.
English: In animal reproductive studies, no teratogenic effect was observed.
Danish: I reproduktionsstudier hos dyr er der ikke observeret teratogen virkning.
English: The capsule should be swallowed with water.
Danish: Kapslen bør indtages sammen med vand.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringsystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000) including isolated reports.
Danish: Hyppigheden er defineret som 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) og meget sjælden (< 1/10.000), herunder enkeltstående forekomster.
English: This is important as using more than one medicine at the same time can strengthen or weaken the effects of the medicines.
Danish: Hvis der anvendes mere end et lægemiddel samtidig, kan de forstærke eller svække hinandens virkning.
English: Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Danish: Fortæl din læge, hvis du af en eller anden grund ikke har indtaget din medicin som ordineret.
English: It is not known whether these findings translate into long-term clinical benefits.
Danish: Det vides ikke, om disse resultater har en længerevarende klinisk effekt.
English: Therefore, these patients should be monitored for possible changes in the frequency and/or severity of convulsions.
Danish: Disse patienter bør derfor monitoreres for mulige ændringer i frekvensen og/eller intensiteten af kramperne.
English: The time to reach complete excretion (faecal plus urinary) was 3 to 5 days.
Danish: Tiden til fuldstændig elimination (fækal plus renal) var 3 til 5 dage.
English: Increases in the levels of some liver enzymes may be found in blood tests.
Danish: Forhøjede niveauer af nogle leverenzymer kan ses i blodprøver.
English: Do not change the prescribed dose yourself unless your doctor tells you to.
Danish: Du må ikke ændre på den ordinerede behandling, medmindre din læge har givet dig besked derpå.
English: These symptoms are generally mild, occur at the beginning of treatment and are particularly experienced after meals containing high levels of fat.
Danish: Disse symptomer er generelt milde, forekommer i begyndelsen af behandlingen og især efter måltider med højt fedtindhold.
English: Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K).
Danish: Behandling med orlistat kan muligvis nedsætte absorptionen af fedtopløselige vitaminer (A, D, E og K).
English: If you forget to take your medicine at any time, take it as soon as you remember provided this is within one hour of your last meal, then continue to take it at the usual times.
Danish: Hvis du glemmer at tage din medicin på noget tidspunkt, skal du indtage den, så snart du husker det, forudsat at det er mindre end 1 time efter sidste måltid.
English: Your doctor may suggest you take a multivitamin supplement.
Danish: Din læge vil måske anbefale, at du tager et multivitaminpræparat.
English: Your doctor may need to monitor your blood coagulation.
Danish: Din læge vil måske overvåge dit blods koaguleringssevne.
English: • Medicines for depression, psychiatric disorders or anxiousness
Danish: • Lægemidler mod depression, psykiske lidelser eller angst
English: The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown:
Danish: Den følgende tabel over bivirkninger er baseret på spontane rapporteringer efter markedsføring og frekvensen er derfor ukendt:
English: The undigested fat cannot be absorbed and is eliminated by your body.
Danish: Det fedt, der ikke er blevet nedbrudt, kan ikke optages og vil blive udskilt af din krop.
English: Prescribers should investigate further in case of severe and/or persistent symptoms.
Danish: Den ordinerende læge bør nærmere undersøge tilfælde af alvorlige og/eller vedvarende symptomer.
English: Reproductive system and breast disorders Common: Menstrual irregularity
Danish: Det reproduktive system og mammae Almindelig: Uregelmæssige menstruationer
English: • if you have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract),
Danish: • hvis du har kronisk malabsorptionssyndrom (utilstrækkelig optagelse af føde fra tarmen)
English: Adverse events are listed below by system organ class and frequency.
Danish: Bivirkninger er anført nedenfor, ordnet efter systemorganklasse og hyppighed.
English: • The active substance is orlistat.
Danish: • Aktivt stof: Orlistat.
English: The volume of distribution cannot be determined because the drug is minimally absorbed and has no defined systemic pharmacokinetics.
Danish: Fordelingsvolumenet kan ikke bestemmes på grund af den ringe absorption og mangel på defineret systemisk farmakokinetik.
English: Losing weight may mean you need adjustments to the dose of these medicines.
Danish: Vægttab kan betyde, at det er nødvendigt at justere doserne af disse lægemidler.
English: There is no relevant indication for use of Xenical in children.
Danish: Der er ingen relevante indikationer for brug af Xenical til børn.
English: No special requirements.
Danish: Ingen særlige forholdsregler
English: If a multivitamin supplement is recommended, it should be taken at least two hours after the administration of orlistat or at bedtime.
Danish: Hvis et multivitamintilskud anbefales, skal det tages mindst 2 timer efter indtagelsen af orlistat eller ved sengetid.
English: The cumulative renal excretion of total orlistat-related materials was < 2 % of the given dose.
Danish: Den kumulative renale elimination af orlistat og orlistatrelateret materiale var < 2 % af den indgivne dosis.
English: As with any weight-control program, over-consumption of fat and calories may reduce any weight loss effect.
Danish: Ligesom det gælder for andre afmagringsprogrammer, kan for høj indtagelse af fedt og kalorier reducere ethvert vægttab.
English: Pharmaco-therapeutic group: Peripherally acting antiobesity agent, ATC code A08AB01.
Danish: Farmakoterapeutisk klassifikation: Perifert virkende antiobesitasmiddel, ATC kode: A08AB01.
English: However, orlistat may indirectly reduce the availability of oral contraceptives and lead to unexpected pregnancies in some individual cases.
Danish: Orlistat kan dog indirekte reducere tilgængeligheden af orale antikonceptionsmidler og dermed føre til uventede graviditeter i enkelte tilfælde.
English: Xenical attaches to the enzymes in your digestive system (lipases) and blocks them from breaking down some of the fat you have eaten during your meal.
Danish: Xenical binder sig til enzymer i dit fordøjelsessystem (lipaser) og forhindrer, at de nedbryder noget af det fedt, du har spist i forbindelse med et måltid.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Date of latest renewal: 17 June 2008
Danish: Dato for første markedsføringstilladelse: 29. juli 1998 Dato for sidste fornyelse: 17. juni 2008
English: In vitro orlistat is > 99 % bound to plasma proteins (lipoproteins and albumin were the major binding proteins).
Danish: In vitro er > 99 % af orlistat bundet til plasmaproteiner (hovedsagelig lipoproteiner og albumin).
English: It can be taken immediately before, during a meal or up to one hour after a meal.
Danish: Den kan indtages umiddelbart før, under et måltid eller op til en time efter et måltid.
English: If you take more capsules than you have been told to take, or if someone else accidentally takes your medicine, contact a doctor, pharmacist or hospital as you may need medical attention.
Danish: Hvis du har indtaget flere kapsler, end du er blevet instrueret i at tage, eller hvis en anden ved et uheld har indtaget din medicin, skal du kontakte lægen, apoteket eller skadestuen, fordi det kan være nødvendigt med lægehjælp.
English: Like all medicines, Xenical can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The absence of these interactions has been demonstrated in specific drug-drug-interaction studies.
Danish: Der er vist fravær af disse interaktioner i specifikke lægemiddelinteraktionsstudier.
English: However, there was an unexplained increase in the incidence of bone fractures (6 % versus 2.8 % in the orlistat and placebo groups, respectively).
Danish: Dog var der en uforklaret stigning i incidencen af knoglefrakturer (henholdsvis 6 % mod 2,8 % i orlistat- og placebogrupperne).
English: Xenical is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
Danish: Xenical anbefales ikke til patienter, som tager acarbose (et lægemiddel, som anvendes til at behandle type 2 sukkersyge).
English: Approximately 97 % of the administered dose was excreted in faeces and 83 % of that as unchanged orlistat.
Danish: Ca. 97 % af den indgivne dosis blev elimineret i fæces, og heraf var 83 % uomdannet orlistat.
English: • if you are allergic (hypersensitive) to orlistat or to any of the other ingredients of Xenical,
Danish: • hvis du er overfølsom (allergisk) over for orlistat eller et af de øvrige indholdsstoffer
English: Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Xenical.
Danish: Kontakt din læge eller apotekspersonalet så hurtigt som muligt, hvis du føler dig dårlig, mens du tager Xenical.
English: To gain the maximum benefit from Xenical you should follow the nutrition program recommended to you by your doctor.
Danish: For at opnå de største fordele af Xenical-behandlingen bør du følge den kostomlægning, din læge har anbefalet.
English: The effect of orlistat in patients with hepatic and/or renal impairment, children and elderly patients has not been studied.
Danish: Virkningen af orlistat hos patienter med lever- og nyreinsufficiens, børn og ældre patienter er ikke blevet undersøgt.
English: The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal.
Danish: Den anbefalede dosering af orlistat er en kapsel på 120 mg indtaget med vand umiddelbart før, under eller op til en time efter hvert hovedmåltid.
English: • Amiodarone.
Danish: • Amiodaron.
English: Your doctor may need to monitor your ciclosporin blood levels more frequently than usual.
Danish: Din læge vil måske kontrollere ciclosporin-niveauet i dit blod hyppigere end normalt.
English: When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4).
Danish: Når warfarin eller andre antikoagulantia anvendes i kombination med orlistat, bør INR-værdierne (INR, international normaliseret ratio) monitoreres (se pkt.
English: Orlistat, M1 and M3 are all subject to biliary excretion.
Danish: Orlistat, M1 og M3 elimineres alle via galden.
English: In order to ensure adequate nutrition, patients on a weight control diet should be advised to have a diet rich in fruit and vegetables and use of a multivitamin supplement could be considered.
Danish: For at sikre tilstrækkelig næring skal patienter på diæt rådes til at spise en kost, som er rig på frugt og grøntsager, og brugen af et multivitamintilskud kan overvejes.
English: - Chronic malabsorption syndrome.
Danish: - Kronisk malabsorptionssyndrom.
English: Increase in liver transaminases and in alkaline phosphatase.
Danish: Forhøjede levertransaminaser og forhøjet alkalisk phosphatase.
English: The reason for this difference is that the five 2-year studies included a 4-week diet and placebo lead-in period during which patients lost on average 2.6 kg prior to commencing treatment.
Danish: Årsagen til denne forskel er, at de fem 2-årige studier inkluderede en 4 ugers diæt og placebo indkøringsperiode, hvor patienterne tabte i gennemsnit 2,6 kg, inden behandlingen startede.
English: Xenical may modify the activity of
Danish: Xenical kan ændre virkningen af
English: To gain optimal benefit, avoid the intake of food containing fat between meals, such as biscuits, chocolate and savoury snacks.
Danish: For at opnå det bedste resultat skal du undgå at indtage fedtrig føde imellem måltiderne, såsom kiks, chokolade, chips, kager og slik.
English: Weight loss may also affect the dose of medicines taken for other conditions (e.g. high cholesterol or diabetes).
Danish: Vægttab kan også påvirke dosis af lægemidler, der indtages mod andre lidelser (f.eks. forhøjet kolesterol eller sukkersyge).
English: The primary endpoint was the change in body mass index (BMI) from baseline to the end of the study.
Danish: Det primære endpoint var ændringen i BMI fra udgangspunktet til afslutningen af studiet.
English: Do not use Xenical after the expiry date stated on the carton.
Danish: Brug ikke Xenical efter den udløbsdato, der står på pakningen.
English: Cases of rectal bleeding have been reported with Xenical.
Danish: Der er rapporteret tilfælde af rektal blødning med Xenical.
English: In addition, doses of 240 mg tid have been administered to obese patients for 6 months.
Danish: Derudover er doser på 240 mg 3 gange daglig blevet administreret til adipøse patienter i 6 måneder.
English: Common: Fatigue
Danish: Almindelig: Træthed
English: Very common: Influenza General disorders and administration site conditions
Danish: Meget almindelig: Influenza Almene symptomer og reaktioner på administrationsstedet
English: The mean difference in weight loss with the drug compared to placebo was 3.2 kg.
Danish: Middeldifferencen af vægttab med lægemidlet sammenlignet med placebo var 3,2 kg.
English: Xenical is a medicine used to treat obesity.
Danish: Xenical er et lægemiddel, der anvendes til behandling af fedme.
English: INFORMATION IN BRAILLE xenical
Danish: INFORMATION I BRAILLESKRIFT xenical
English: Inform your doctor whether you suffer from problems with your kidney.
Danish: Fortæl din læge, hvis du har problemer med dine nyrer.
English: Therefore, if you miss a main meal or if you have a meal containing no fat, Xenical need not be taken.
Danish: Det vil sige, at hvis et hovedmåltid ikke indtages, eller du indtager et måltid, der ikke indeholder fedt, er det ikke nødvendigt at indtage Xenical.
English: No interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine Gastrointestinal Therapeutic System (GITS), nifedipine slow release, sibutramine or alcohol have been observed.
Danish: Der er ikke observeret interaktioner med amitriptylin, atorvastatin, biguanider, digoxin, fibrater, fluoxetin, losartan, phenytoin, phentermine, pravastatin, nifedipin Gastro Intestinal Therapeutic System (GITS), langsom opløselig (slow release) nifedipin, sibutramin eller alkohol.
English: Ciclosporin blood levels should be monitored until stabilised.
Danish: Monitoreringen af ciclosporinniveauet i blodet skal fortsætte, indtil niveauet er stabilt.
English: The results were significantly superior in the orlistat group (difference in BMI of 0.86 kg/m2 in favour of orlistat).
Danish: Resultaterne var signifikant bedre i orlistatgruppen (forskellen i BMI var 0,86 kg/m2 bedre i orlistatgruppen).
English: The capsule has a turquoise cap and turquoise body bearing the imprint of “XENICAL 120”.
Danish: Kapslen har en turkis hætte og turkis krop med påtryk af “XENICAL 120”.
English: Xenical reduces the absorption of supplements of some fat soluble nutrients, particularly beta-carotene and vitamin E. You should therefore follow your doctor's advice in taking a well balanced diet rich in fruit and vegetables.
Danish: Xenical nedsætter evnen til at optage visse fedtopløselige næringsstoffer, især betacaroten og vitamin E. Du bør derfor følge din læges anvisninger og spise en velafbalanceret kost med mange frugter og grønsager.
English: Do not take XENICAL
Danish: Tag ikke XENICAL
English: The vast majority of patients receiving up to four full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range.
Danish: Hovedparten af patienterne, som fik behandling med orlistat i op til fire år i kliniske studier, havde A-, D-, E- og K- og betakarotenniveauer, som forblev inden for normalområdet.
English: It works in your digestive system to block about one-third of the fat in the food you eat from being digested.
Danish: Det virker i dit fordøjelsessystem, hvor det forhindrer, at ca. en tredjedel af det fedt, du spiser, optages.
English: Rectal bleeding Diverticulitis Pancreatitis
Danish: Rektal blødning Diverticulitis Pancreatitis
English: - Hypersensitivity to the active substance or to any of the excipients.
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpstofferne.
English: M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1000 and 2500 fold less than orlistat respectively).
Danish: M1 og M3 har en åben betalaktonring med en yderst svag lipasehæmmende aktivitet (1000 henholdsvis 2500 gange mindre end orlistat).
English: PVC/ PVDC blisters containing 21, 42 and 84 hard capsules.
Danish: PVC/ PVDC blister indeholdende 21, 42 og 84 hårde kapsler.
English: In clinical trials, the decrease in bodyweight with orlistat treatment was less in type II diabetic patients than in non-diabetic patients.
Danish: I kliniske forsøg var vægttabet ved orlistatbehandling mindre hos type 2-diabetikere end hos ikkediabetikere.
English: Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.
Danish: Doser af orlistat på mere end 120 mg 3 gange daglig har ikke vist at have en større virkning.
English: In a multi-centre (US, Canada), parallel-group, double-blind, placebo-controlled study, 539 obese adolescent patients were randomised to receive either 120 mg orlistat (n=357) or placebo (n=182) three times daily as an adjunct to a hypocaloric diet and exercise for 52 weeks.
Danish: I et multicenter (U.S.A., Canada), dobbeltblindet, placebokontrolleret studie blev 539 adipøse, unge patienter randomiseret i parallelle grupper til enten at få 120 mg orlistat (n = 357) eller placebo (n = 182) 3 gange daglig som supplement til en hypokalorisk diæt og motion i 52 uger.
English: Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.
Danish: Humane studier og dyrestudier viser at alle systemiske virkninger, der kan tillægges orlistats lipasehæmmende egenskaber, formentlig er hurtigt reversible.
English: This risk is increased in patients with underlying chronic kidney disease and/or volume depletion (see section 4.8).
Danish: Denne risiko er øget hos patienter med underliggende kronisk nyresygdom og/eller volumendepletion (se pkt.
English: Very common side effects (affects more than 1 user in 10)
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter)
English: 42 hard capsules
Danish: 42 hårde kapsler
English: 84 hard capsules
Danish: 84 hårde kapsler
English: In view of this low inhibitory activity and the low plasma levels at therapeutic doses (average of 26 ng/ml and 108 ng/ml respectively), these metabolites are considered to be pharmacologically inconsequential.
Danish: På grund af den svage lipasehæmmende aktivitet og de lave plasmaniveauer ved terapeutiske doser (i gennemsnit 26 ng/ml henholdsvis 108 ng/ml) anses disse metabolitter for at være uden farmakologisk betydning.
English: Xenical has been studied in long-term clinical studies of up to 4 years duration.
Danish: Der er udført studier på mennesker med Xenical af op til 4 års varighed.
English: Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours.
Danish: Efter seponering af behandlingen falder indholdet af fækalt fedt til niveauet, før behandlingen blev påbegyndt inden for 48 til 72 timer.
English: Very common: Headache Respiratory, thoracic and mediastinal disorders Very common:
Danish: Meget almindelig: Hovedpine Luftveje, thorax og mediastinum Meget almindelig:
English: Xenical has no influence on the ability to drive and use machines.
Danish: Xenical påvirker ikke evnen til at føre motorkøretøj og betjene maskiner.
English: The majority of unwanted effects related to the use of Xenical result from its local action in your digestive system.
Danish: De fleste af de bivirkninger, der ses i forbindelse med brug af Xenical, skyldes virkningen lokalt i dit fordøjelsessystem.
English: Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2).
Danish: Patienter bør rådes til at overholde de kostvejledninger, de har modtaget (se pkt.
English: There are some case reports of reduced efficacy of antiretroviral HIV medicines, antidepressants antipsychotics (including lithium) and benzodiazepines coincidental to the initiation of orlistat treatment in previously well-controlled patients.
Danish: Der foreligger nogle rapporter om nedsat effekt af antiretrovirale lægemidler mod hiv, antidepressiva, antipsykotika (inklusive lithium) samt benzodiazepiner, som var sammenfaldende med initiering af orlistat-behandling hos patienter, som tidligere var velmedicineret.