FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have cholestasis (liver disorder)
Danish: • hvis du har kolestase (leversygdom)
English: Antiretrovirals for HIV: Orlistat may potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the efficacy of antiretroviral medications for HIV (see section 4.5).
Danish: Antiretrovirale lægemidler til behandling af hiv: Orlistat kan muligvis reducere absorptionen af antiretrovirale lægemidler mod hiv og påvirke virkningen af de antiretrovirale lægemidler mod hiv negativt (se pkt.4.5).
English: Common side effects (affects 1 to 10 users in 100)
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 patienter)
English: As it is not known whether orlistat is secreted into human milk, orlistat is contra-indicated during breast-feeding.
Danish: Eftersom det ikke vides, om orlistat udskilles i modermælken, er orlistat kontraindiceret under amning.
English: Upper respiratory infection Lower respiratory infection
Danish: Infektion i øvre luftveje Infektion i nedre luftveje
English: The majority of orlistat overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported with recommended dose.
Danish: I de fleste tilfælde af overdosering, som blev rapporteret i perioden efter markedsføring, blev det rapporteret, at der enten ikke var bivirkninger, eller at de rapporterede bivirkningerne var de samme som for den anbefalede dosis.
English: The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine (see section 4.4).
Danish: Mekanismen for dette, selvom den ikke er påvist, kan involvere et fald i absorptionen af jodsalte og/eller levothyroxin (se pkt.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Danish: Non-kliniske data fra konventionelle studier hos farmakologisk sikkerhed, toksicitet ved gentagne doseringer, genotoksicitet, karcinogent potentiale og reproduktionstoksicitet viste ingen særlig risiko for mennesker.
English: In a 4 year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1 and 2 year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the four year period.
Danish: I et klinisk forsøg, der forløb over 4 år, var det generelle bivirkningsmønster i overenstemmelse med det, der blev rapporteret for 1- og 2-års studierne, hvor den samlede incidens af gastrointestinale bivirkninger, der optrådte i år 1, aftager år for år i løbet af den 4-årige periode.
English: Antidiabetic medicinal product treatment may have to be closely monitored when taking orlistat.
Danish: Antidiabetisk behandling med lægemidler bør monitoreres omhyggeligt under orlistatindgift.
English: In orlistat-treated patients, the mean difference from placebo in weight loss was 1.83 kg to 3.06 kg and the mean difference from placebo in HbA1c reduction was 0.18 % to 0.55 %.
Danish: Middeldifferencen af vægttab hos orlistatbehandlede patienter sammenlignet med placebo var 1,83 kg til 3,06 kg og middeldifferencen mellem placebo og HbA1c-reduktion var 0,18 % til 0,55 %.
English: Taking Xenical during pregnancy is not recommended.
Danish: Behandling med Xenical anbefales ikke ved graviditet.
English: Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI > 28 kg/m²) with associated risk factors.
Danish: Xenical er, når det anvendes sammen med en let diæt med lavt kalorieindhold, indiceret til behandling af adipøse patienter med et body mass index (BMI) større end eller lig med 30 kg/m2 eller overvægtige patienter (BMI ≥ 28 kg/m2) med associerede risikofaktorer.
English: Skin blistering (including blisters that burst).
Danish: Blærer på huden (herunder blærer, som brister).
English: Data from the 4-year clinical trial also suggested that weight loss achieved with orlistat delayed the development of type 2 diabetes during the study (cumulative diabetes cases incidences: 3.4 % in the orlistat group compared to 5.4 % in the placebo-treated group).
Danish: Data fra det 4-årige kliniske forsøg tydede også på, at vægttabet, der blev opnået med orlistat, forsinkede udviklingen af type 2-diabetes under studiet (den kumulerede diabetesincidens: 3,4 % i orlistatgruppen i forhold til 5,4 % i placebogruppen).
English: The incidence of adverse events decreased with prolonged use of orlistat.
Danish: Incidensen af bivirkningerne mindskes ved længerevarende anvendelse af orlistat.
English: In the 2-year studies and the 4-year study, a hypocaloric diet was used in association with treatment in both the orlistat and the placebo treated groups.
Danish: I 2-års studierne samt i 4-års studiet blev der i tilknytning til behandlingen givet en hypokalorisk diæt til både den orlistat- og den placebobehandlede gruppe.
English: Lack of interactions
Danish: Ingen interaktion
English: A decrease in ciclosporin plasma levels has been observed in a drug-drug-interaction study and also reported in several cases, when orlistat was administered concomitantly.
Danish: Der er blevet observeret et fald i plasmakoncentrationen af ciclosporin i et lægemiddelinteraktionsstudie og i flere tilfælde, når orlistat blev administreret samtidig.
English: Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5 % of your body weight as measured at the start of treatment with Xenical.
Danish: Din læge vil stoppe behandlingen med Xenical efter 12 uger, hvis du ikke har tabt mindst 5 % af den vægt, du havde, da du startede Xenicalbehandlingen.
English: Children Xenical is not intended to be used in children.
Danish: Børn Xenical er ikke beregnet til børn.
English: Xenical can be taken immediately before, during a meal or up to one hour after a meal.
Danish: Xenical kan tages umiddelbart før et måltid, under et måltid og op til en time efter et måltid.
English: The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals per day.
Danish: Den sædvanlige dosis er en kapsel på 120 mg til hvert af de tre daglige hovedmåltider.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.
Danish: Symptomerne kan omfatte gulfarvning af hud og øjne, kløe, mørk urin, mavesmerter og ømhed i leveren (som viser sig som smerter foran, under brystkassen på højre side), nogle gange med appetitløshed.
English: For orlistat no clinical data on exposed pregnancies are available.
Danish: Der foreligger ikke kliniske data om eksponering for orlistat under graviditet.
English: The following table of undesirable effects (first year of treatment) is based on adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in clinical trials of 1 and 2 years duration:
Danish: Nedenstående tabel over bivirkninger (første behandlingsår) er baseret på uønskede hændelser, der forekom med en hyppighed på > 2 % og med en incidens på ≥ 1 % over placebo i kliniske forsøg af 1 og 2 års varighed:
English: Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal.
Danish: Studier hos normalvægtige og adipøse frivillige forsøgspersoner har vist, at absorptionen af orlistat er minimal.
English: Xenical capsules are turquoise with the imprint “XENICAL 120” and are supplied in blister packs and glass bottles, containing 21, 42 and 84 capsules.
Danish: Xenicalkapsler er turkise og påtrykt “XENICAL 120” og leveres i blisterpakninger og glasflasker, indeholdende 21, 42 og 84 kapsler.
English: If you forget to take XENICAL
Danish: Hvis du har glemt at tage Xenical
English: The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy leading sometimes to renal failure.
Danish: Anvendelse af orlistat kan være forbundet med hyperoxaluri og oxalatnefropati og kan i nogle tilfælde medføre nyresvigt.
English: Always take Xenical exactly as your doctor has told you.
Danish: Tag altid Xenical nøjagtigt efter lægens anvisning.
English: If orlistat is taken with a meal very high in fat, the possibility of gastrointestinal adverse reactions may increase.
Danish: Hvis orlistat indtages sammen med et måltid, der har et højt fedtindhold kan der være en øget risiko for gastrointestinale bivirkninger.
English: Store in original package and keep the blister in the outer carton in order to protect from light and moisture.
Danish: Opbevares i den originale emballage og opbevar blisterkort i den ydre karton for at beskytte mod lys og fugt.
English: The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies.
Danish: Der er påvist fravær af interaktion mellem orale antikonceptionsmidler og orlistat i specifikke interaktionsstudier.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy.
Danish: Behandling med orlistat bør seponeres efter 12 uger, hvis patienterne ikke har været i stand til at tabe mindst 5 % af deres legemsvægt beregnet fra starten af behandling.
English: PHARMACEUTICAL FORM AND CONTENTS 21 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 21 hårde kapsler
English: The use of orlistat may be associated with renal stones in patients suffering from chronic kidney disease.
Danish: Brugen af orlistat kan være forbundet med dannelse af nyresten hos patienter, som lider af en kronisk nyresygdom.
English: If you have missed several doses, please inform your doctor and follow the advice given to you.
Danish: Hvis du har glemt flere doser efter hinanden, skal du kontakte din læge og følge hans råd.
English: Xenical should be taken with a well-balanced, calorie controlled diet that is rich in fruit and vegetables and contains an average of 30 % of the calories from fat.
Danish: Xenical bør indtages sammen med en afbalanceret, kaloriefattig kost, der er rig på frugt og grøntsager, og hvor ca. 30 % af kalorierne kommer fra fedt.
English: Driving and using machines Xenical has no known effect on your ability to drive a car or operate machinery.
Danish: Trafik og arbejdssikkerhed Xenical påvirker ikke din evne til at føre motorkøretøj eller betjene maskiner.
English: However, if such concomitant use is unavoidable, more frequent monitoring of ciclosporin blood levels should be performed both after addition of orlistat and upon discontinuation of orlistat in ciclosporin treated patients.
Danish: Hvis samtidig administration imidlertid er uundgåelig, skal ciclosporinbehandlede patienters ciclosporinniveau i blodet monitoreres oftere, både før orlistatterapi påbegyndes, og efter at behandlingen er ophørt.
English: The daily intake of fat should be distributed over three main meals.
Danish: Den daglige fedtindtagelse bør fordeles over 3 hovedmåltider.
English: In addition your daily intake of fat should be distributed evenly over three main meals because if Xenical is taken with a meal very high in fat, the possibility of gastrointestinal effects may increase.
Danish: Den daglige fedtindtagelse bør fordeles på 3 hovedmåltider, da indtagelse af Xenical sammen med et måltid, der har et meget højt fedtindhold, øger risikoen for bivirkninger fra tarmen.
English: Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
Danish: Ved enkeltdoser på 800 mg orlistat og multiple doser på op til 400 mg 3 gange daglig i 15 dage har der ikke været rapporteret signifikant negative fund blandt personer med normal vægt og blandt adipøse personer.
English: The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30 % of calories from fat.
Danish: Patienten bør være på en let diæt med lavt kalorieindhold, som er ernæringsmæssigt afbalanceret, og hvor ca. 30 % af kalorierne stammer fra fedt.
English: Common: Urinary tract infection
Danish: Almindelig: Urinvejsinfektioner
English: Pancreatitis (inflammation of the pancreas).
Danish: Pancreatitis (betændelse i bugspytkirtlen).
English: A slight decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly.
Danish: Der er observeret et lille fald i plasmakoncentrationen af amiodaron, givet som enkeltdosis, hos et mindre antal raske, frivillige forsøgspersoner, som samtidig fik orlistat.
English: Faecal incontinence Abdominal distension* Tooth disorder Gingival disorder
Danish: Fækal inkontinens Abdominal distension* Tandsygdomme Gingivale sygdomme
English: Adverse reaction/event
Danish: Bivirkning/hændelse
English: Glass bottles with desiccant containing 21, 42 and 84 hard capsules.
Danish: Glasflasker med tørrekapsel indeholdende 21, 42 og 84 hårde kapsler.
English: If a meal is missed or contains no fat, the dose of orlistat should be omitted.
Danish: Hvis et måltid springes over eller ikke indeholder fedt, bør man undlade at indtage orlistat.
English: The following side effects have also been reported but their frequency cannot be estimated from the available data:
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (kan ikke angives ud fra de data, der er tilgængelige):
English: OUTER CARTON AND BOTTLE LABEL
Danish: YDRE KARTON OG ETIKET TIL BEHOLDER
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg på apoteket hvordan du skal bortskaffe medicinrester.
English: What you need to know before you take XENICAL
Danish: Det skal du vide, før du begynder at tage XENICAL
English: Your daily intake of fat, carbohydrate and protein should be distributed over three meals.
Danish: Din daglige indtagelse af fedt, kulhydrat og protein bør fordeles over 3 måltider.
English: The main symptoms are itching, rash, wheals (slightly elevated, itchy skin patches that are paler or redder than surrounding skin), severe difficulty in breathing, nausea, vomiting and feeling unwell.
Danish: Hovedsymptomerne er kløe, udslæt, hævelser på huden (let ophøjede, kløende hudområder, som er blegere eller rødere end den omgivende hud), alvorligt åndedrætsbesvær, kvalme, opkastninger og utilpashed.
English: Hypersensitivity (e.g. pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis)
Danish: Overfølsomhed (f.eks. kløe, udslæt, urticaria, angioødem, bronkospasmer og anafylakse)
English: NAME OF THE MARKETING AUTHORISATION HOLDER CHEPLAPHARM Arzneimittel GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN CHEPLAPHARM Arzneimittel GmbH
English: Hepatitis (inflammation of the liver).
Danish: Hepatitis (leverbetændelse).
English: Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere information
English: Cases of hypothyroidism and/or reduced control of hypothyroidism may occur.
Danish: Tilfælde af hypotyreoidisme og/eller dårligere kontrol af hypotyreoidisme kan forekomme.
English: Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ml) eight hours following oral administration of orlistat.
Danish: Otte timer efter oral indgift af orlistat kunne der ikke måles plasmakoncentrationer (< 5 ng/ml) af intakt orlistat.
English: Oily evacuation Increased defecation
Danish: Vandige afføringer Olieagtige udtømninger Øget defækation
English: Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42 % of the total plasma concentration.
Danish: I et studie af adipøse patienter bestod lille, systemisk absorberede fraktion af orlistat af to større metabolitter, M1 (4-member hydrolyseret laktonring) og M3 (M1 med N-formyl leucindelen spaltet fra), som udgjorde ca. 42 % af den totale plasmakoncentration.
English: Be sure to discuss these and other medicines you may be taking with your doctor.
Danish: Du skal huske at fortælle din læge om disse lægemidler, og om andre lægemidler du indtager.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 120 mg orlistat.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder 120 mg orlistat.
English: In patients receiving amiodarone treatment, the clinical relevance of this effect remains unknown but may become clinically relevant in some cases.
Danish: Hos patienter, som er i amiodaronbehandling, er den kliniske relevans af dette endnu ukendt.
English: Oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
Danish: Oxalat-nefropati (ophobning af calciumoxalat, som kan medføre nyresten).
English: The possibility of experiencing gastrointestinal adverse reactions (see section 4.8) may increase when orlistat is taken with a diet high in fat (e.g. in a 2000 kcal/day diet, > 30 % of calories from fat equates to > 67 g of fat).
Danish: 4.8) kan øges, når orlistat indtages sammen med en diæt med et højt fedtindhold (f.eks. en diæt med 2000 kcal/dag, hvor > 30 % af kalorierne er fra fedt svarende til > 67 g fedt).
English: Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet.
Danish: Xenical anvendes til behandling af fedme sammen med en kaloriefattig diæt.
English: The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
Danish: Den daglige indtagelse af fedt, kulhydrat og protein bør fordeles over 3 hovedmåltider.
English: Capsule shell: gelatine indigo carmine (E132) titanium dioxide (E171) edible printing ink (black iron oxide, ammonia solution concentrated, potassium hydroxide, shellac, propylene glycol)
Danish: Kapselskal: gelatine indigotin I (E132) titandioxid (E171) spiselig tryksværte (sort jernoxid, koncentreret ammoniakopløsning, kaliumhydroxid, shellac, propylenglycol)
English: Rectal pain/discomfort, soft stools, incontinence (stools), bloating (experienced by some people with type 2 diabetes), tooth/gum disorder, irregularity of menstrual cycle, tiredness.
Danish: Smerter/ubehag i endetarmen, blød afføring, inkontinens (afføring), oppustethed (hos patienter med type 2-diabetes), tand- og tandkødssygdomme, uregelmæssig menstruationscyklus, træthed.
English: In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.
Danish: Ved terapeutiske doser kunne der kun måles sporadiske og yderst lave koncentrationer af intakt orlistat i plasma (< 10 ng/ml eller 0,02 mikromol) uden tegn på akkumulering, hvilket er i overensstemmelse med en minimal absorption.
English: Adverse reactions to orlistat are largely gastrointestinal in nature.
Danish: Bivirkningerne ved orlistat er hovedsageligt gastrointestinale.
English: • if you are breast-feeding
Danish: • hvis du ammer
English: Capsule filling: microcrystalline cellulose (E460) sodium starch glycolate (type A) povidone (E1201) sodium laurilsulfate talc
Danish: Kapselindhold: cellulose, mikrokrystallinsk (E460) natriumstivelsesglycolat (type A) povidon (E1201) natriumlaurilsulfat talcum
English: Each capsule contains 120 mg of orlistat.
Danish: Hver kapsel indeholder 120 mg orlistat.
English: Abdominal pain/discomfort Oily spotting from the rectum Flatus with discharge Faecal urgency Fatty/oily stool Flatulence
Danish: Smerter og ubehag i abdomen Olielignende pletter fra rectum Flatus med udflåd Imperiøs defækationstrang Fedt-/olieagtig afføring Flatulens
English: * only unique treatment adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in obese type 2 diabetic patients.
Danish: Almindelig: Angst *Kun behandlingsunikke bivirkninger, som forekom med en frekvens > 2 % og med en incidens ≥ 1 % i forhold til placebo i adipøse type 2-diabetikere.
English: The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see section 4.5).
Danish: Det anbefales at anvende et supplerende antikonceptionsmiddel for at undgå risiko for svigt af oral kontraception, der kan forekomme i tilfælde af svær diarré (se pkt.
English: Overall, after one year of treatment, the percentage of patients taking 120 mg orlistat who lost 10 % or more of their body weight was 20 % with orlistat 120 mg compared to 8 % of patients taking placebo.
Danish: Efter 1 års behandling udgjorde andelen af patienter, der fik 120 mg orlistat og som tabte 10 % eller mere af deres legemsvægt, i alt 20 % blandt dem, der fik orlistat 120 mg sammenlignet med 8 % blandt dem, der fik placebo.
English: This medicine can cause harmless changes in your bowel habits, such as fatty or oily stools, due to the elimination of undigested fat in your faeces.
Danish: Xenical kan medføre harmløse ændringer i dit afføringsmønster i form af en mere fedtrig eller olielignende afføring, fordi afføringen indeholder uomdannet fedt.
English: Xenical only works in the presence of dietary fat.
Danish: Xenical virker kun i forbindelse med kostens fedt.
English: Data from the 4-year XENDOS clinical trial showed that 60 % of orlistat patients and 35 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment.
Danish: Data fra det 4-årige klinisk forsøg, XENDOS, viste, at 60 % af orlistatpatienterne og 35 % af placebopatienterne tabte mindst 5 % af deres udgangskropsvægt efter 12 ugers behandling.
English: Other medicines and Xenical
Danish: Brug af anden medicin sammen med Xenical
English: It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases.
Danish: Orlistats terapeutiske virkninger udøves i ventriklens og tyndtarmens lumina, hvor der dannes kovalente bindinger på det aktive serinbindingsted af gastro- og pankreaslipaser.
English: MARKETING AUTHORISATION NUMBERS EU/1/98/071/001-006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/98/071/001-006
English: Decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat (see section 4.4 and 4.5)
Danish: Der er rapporteret reduceret protrombin, forhøjet INR og dårligt afbalanceret antikoagulationsbehandling, som har forårsaget variationer i de hæmostatiske parametre hos patienter, der er behandlet med antikoagulantia i forbindelse med orlistat (se pkt.
English: Pooled data from five 2 year studies with orlistat and a hypocaloric diet showed that 37 % of orlistat patients and 19 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment.
Danish: Sammenlagte data fra fem 2-års studier med orlistat og en hypokalorisk diæt viste, at 37 % af orlistatpatienterne og 19 % af placebopatienterne tabte mindst 5 % af deres udgangskropsvægt efter 12 ugers behandling.
English: Co-administration of orlistat with ciclosporin is not recommended (see section 4.5).
Danish: Samtidig administration af ciclosporin frarådes (se pkt.