FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with kidney disease should consult a doctor before starting treatment with alli, as the use of orlistat may be associated with hyperoxaluria and oxalate nephropathy leading sometimes to renal failure.
Danish: Patienter med nyresygdom bør konsultere en læge inden behandling med alli, idet anvendelse af orlistat kan være forbundet med hyperoxaluri og oxalatnefropati og i nogle tilfælde kan medføre nyresvigt.
English: The clinical relevance of this effect in patients receiving amiodarone treatment remains unknown.
Danish: Hos patienter i behandling med amiodaron er den kliniske relevans af denne virkning endnu ukendt.
English: - Write down what you eat in a food diary, including the calorie and fat content.
Danish: - Før dagbog over, hvad du spiser, og angiv kalorie- og fedtindholdet i kosten.
English: Talk to your doctor before taking alli if you are taking - amiodarone, used for heart rhythm problems.
Danish: Tal med lægen, før du begynder at tage alli, hvis du tager - amiodaron mod forstyrrelser i hjerterytmen.
English: A blue carry case (shuttle) is included in this pack for carrying your daily dose of alli.
Danish: Pakningen indeholder også et blåt etui (shuttle), der kan indeholde din daglige dosis af alli.
English: Macrogol stearate (E431)
Danish: Macrogolstearat (E431)
English: Antiretroviral medicinal products
Danish: Antiretrovirale lægemidler
English: Diverticulitis
Danish: Divertikulitis
English: 4.1 Therapeutic indications alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet. 4.2 Posology and method of administration
Danish: 4.1 Terapeutiske indikationer alli er indiceret til vægttab hos overvægtige voksne med body mass index (BMI) ≥28 kg/m2 og skal kombineres med en let diæt med lavt kalorie- og fedtindhold.
English: - Ask your doctor or pharmacist if you need more information or advice.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Holds 3 tablets.
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Kan indeholde 3 tabletter.
English: - Hepatitis (inflammation of the liver).
Danish: - Leverbetændelse (hepatitis).
English: • if you are taking a thyroid medicine (levothyroxine).
Danish: • tager medicin for sygdomme i skoldbruskkirtlen (levothyroxin).
English: The tablet should be chewed.
Danish: Tabletten skal tygges.
English: Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K) (see section 4.5).
Danish: Behandlingen med orlistat kan potentielt nedsætte absorption af fedtopløselige vitaminer (A, D, E og K) (se pkt.
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 en undersøgelse af adipøse patienter bestod den lille, systemisk absorberede fraktion af dosis af to større metabolitter, M1 (firleddet hydrolyseret laktonring) og M3 (M1 med N-formyl leucindelen spaltet fra), som udgjorde ca. 42 % af den totale plasmakoncentration.
English: The disposition of orlistat appeared to be similar between normal weight and obese volunteers.
Danish: Udskillelsen af orlistat var tilsyneladende ens blandt normalvægtige og adipøse forsøgspersoner.
English: - if you are allergic to orlistat or any of the ingredients.
Danish: - er allergisk over for orlistat eller et af de øvrige indholdsstoffer.
English: Symptoms may include lower stomach (abdominal) pain, particularly on the left side, possibly with fever and constipation.
Danish: Symptomerne kan omfatte smerter nederst i maven (abdomen), især i venstre side, og kan være ledsaget af feber og forstoppelse.
English: - you should not take alli for more than six months.
Danish: - Du må ikke tage alli i mere end 6 måneder.
English: Sucrose monopalmitate (E473)
Danish: Sucrosemonopalmitat (E473)
English: The oral contraceptive pill and alli - The oral contraceptive pill may be less effective if you get severe diarrhoea.
Danish: P-piller og alli - Virkningen af p-piller kan forringes, hvis du får kraftig diarré.
English: Before you start taking the tablets, begin your reduced calorie, lower-fat diet and give your body a few days to adjust to your new eating habits.
Danish: Før du begynder at tage tabletterne, skal du begynde at spise kalorie- og fedtfattigt, så du giver kroppen et par dage til at vænne sig til dine nye kostvaner.
English: The other ingredients are: - Capsule filling: microcrystalline cellulose (E460), sodium starch glycolate, povidone (E1201),
Danish: Øvrige indholdsstoffer: - Kapselindhold: Mikrokrystallinsk cellulose (E460), natriumstivelsesglycolat, povidon (E1201),
English: If you weigh less than the weight shown for your height, do not take alli.
Danish: Tag ikke alli, hvis du vejer mindre end den vægt, der er angivet ud for din højde.
English: - if you are taking a medicine for high blood pressure.
Danish: - medicin mod for højt blodtryk.
English: You should see your doctor for a check-up.
Danish: Du bør derfor få lavet en helbredsundersøgelse hos lægen.
English: Each tablet contains ingredients that help alli work efficiently in your digestive system and chewing the tablet releases these substances quickly.
Danish: Hver tablet indeholder ingredienser, der hjælper alli med at virke effektivt i fordøjelsessystemet.
English: • if you are taking a medicine for epilepsy.
Danish: • tager medicin mod epilepsi.
English: How alli works
Danish: Sådan virker alli
English: Choose the day you will start taking the capsules ahead of time.
Danish: Fastsæt på forhånd den dato, hvor du vil begynde at tage kapslerne.
English: Before you start taking the capsules, begin your reduced calorie, lower-fat diet and give your body a few days to adjust to your new eating habits.
Danish: Før du begynder at tage kapslerne, skal du begynde at spise kalorie- og fedtfattigt, så du giver kroppen et par dage til at vænne sig til dine nye kostvaner.
English: - Most users who experience these effects find that they can manage and control them by adjusting their diet. Do not be concerned if you do not experience any of these problems.
Danish: - De fleste, der får disse gener, finder frem til, hvordan de kan kontrollere dem ved at ændre kosten.
English: Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal.
Danish: Undersøgelser af normalvægtige og adipøse frivillige forsøgspersoner har vist, at absorptionen af det aktive stof er minimal.
English: What you need to know before you take alli
Danish: Det skal du vide, før du begynder at tage alli
English: • if you have cholestasis (condition where the flow of bile from the liver is blocked).
Danish: • har kolestase (tilstand, hvor udstrømningen af galde fra leveren er blokeret).
English: For information on how to set your calorie and fat targets, see Further helpful information in the blue pages in section 6.
Danish: Du kan læse nærmere om, hvilke mål du bør sætte for kalorie- og fedtindhold i din kost, i punkt 6 under Flere nyttige oplysninger på de blå sider.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering er uønskede bivirkninger ordnet efter sværhedsgrad med den sværeste øverst.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Holds 3 capsules.
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Kan indeholde 3 kapsler.
English: If you have set a target of 1400 calories per day, for example, the maximum amount of fat allowed per meal would be 15 g. To stay within your daily allowance for fat, snacks should contain no more than 3 g of fat.
Danish: Hvis du f.eks. har fastsat et kaloriemål på 1400 kalorier om dagen, må du højst få 15 g fedt pr. måltid.
English: • if you are pregnant or breast-feeding.
Danish: • er gravid eller ammer.
English: By familiarising yourself with portions you will be less likely to accidentally exceed your fat target.
Danish: Ved at overveje portionens størrelse vil du blive mindre tilbøjelig til at indtage for meget fedt ved en fejltagelse.
English: - Swallow the capsule whole with water.
Danish: - Synk kapslen hel med et glas vand.
English: An additional contraceptive method is recommended in case of severe diarrhoea (see section 4.4).
Danish: Det anbefales at anvende en supplerende præventionsmetode i tilfælde af svær diarré (se pkt.
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 serinbindingssted af gastro- og pankreaslipaser.
English: For every 2 kg (4 lb) you lose from dieting alone, alli might help you lose up to 1 kg (2 lb) more.
Danish: For hver gang du taber 2 kg i kraft af kostomlægningen, kan alli muligvis hjælpe dig med at tabe op til 1 kg ekstra.
English: Talk to your doctor or pharmacist when taking alli
Danish: Tal med lægen eller apotekspersonalet, hvis du tager alli sammen med
English: MARKETING AUTHORISATION NUMBERS EU/1/07/401/007-011
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/07/401/007-011
English: Set your calorie and fat targets
Danish: Fastsæt dine mål for kalorie- og fedtindtag
English: This usually means one tablet at breakfast, lunch and dinner.
Danish: Det betyder sædvanligvis 1 tablet til morgenmaden, 1 til frokosten og 1 til aftensmaden.
English: Concurrent use of alli and warfarin or other oral anticoagulants is contraindicated (see section 4.3).
Danish: Samtidig brug af alli og warfarin eller andre orale antikoagulantia er kontraindiceret (se pkt.
English: - Capsule shell: gelatin, indigo carmine (E132), titanium dioxide (E171), sodium laurilsulfate,
Danish: - Kapselskal: Gelatine, indigotin I (E132), titandioxid (E171), natriumlaurilsulfat,
English: Antiretrovirals for HIV
Danish: Antiretrovirale lægemidler mod HIV
English: The bottle also contains two sealed canisters containing silica gel desiccant.
Danish: Beholderen indeholder også to forseglede tørrekapsler med silicagel.
English: LIST OF EXCIPIENTS Contains lactose and sucrose.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactose og saccharose.
English: The alli weight loss programme combines the capsules with an eating plan and a wide range of resources to help you understand how to eat a reduced calorie, lower-fat diet and guidelines for becoming more active.
Danish: alli vægttabsprogrammet kombinerer kapslerne med en kostplan og en lang række midler, der hjælper dig med at fastlægge en kalorie- og fedtfattig kost og giver dig ideer til, hvordan du kan blive mere aktiv.
English: This usually means one capsule at breakfast, lunch and dinner.
Danish: Det betyder sædvanligvis 1 kapsel til morgenmaden, 1 til frokosten og 1 til aftensmaden.
English: So for every 2 kg (4 lb) you lose from dieting alone, alli chewable tablets might help you lose 1 kg (2 lb) more.
Danish: Så for hver gang du taber 2 kg i kraft at kostomlægningen, kan alli tyggetabletterne muligvis hjælpe dig med at tabe 1 kg ekstra.
English: Patients who are taking a medicinal product for hypertension or hypercholesterolaemia should consult a doctor or pharmacist when taking alli, in case it is necessary to adjust the dose of these medicinal products.
Danish: Patienter, som er i medicinsk behandling for hypertension eller hyperkolesterolæmi, bør konsultere lægen om behovet for at justere doseringen af disse lægemidler ved behandling med alli.
English: Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Adults 18 and over
Danish: Til voksne overvægtige på 18 år og derover.
English: The alli weight loss programme combines the tablets with an eating plan and a wide range of resources to help you understand how to eat a reduced calorie, lower-fat diet and guidelines for becoming more active.
Danish: alli vægttabsprogrammet kombinerer tabletterne med en kostplan og en lang række midler, der hjælper dig med at fastlægge en kalorie- og fedtfattig kost og giver dig ideer til, hvordan du kan blive mere aktiv.
English: The capsule should be taken with water immediately before, during or up to 1 hour after each main meal.
Danish: Kapslerne bør tages med vand lige før, under eller op til 1 time efter hvert hovedmåltid.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARRY CASE (SHUTTLE)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETUI (SHUTTLE)
English: Glycerol dibehenate (E471)
Danish: Glyceroldibehenat (E471)
English: alli with food and drink alli should be used along with a reduced calorie, lower-fat diet.
Danish: Brug af alli sammen med mad og drikke alli bør anvendes sammen med en kalorie- og fedtfattig kost.
English: Maximum amount of fat allowed from snacks per day
Danish: Maksimal mængde fedt om dagen fra mellemmåltider
English: - Take alli just before, during or up to one hour after meals.
Danish: - Tag alli lige før, under eller op til én time efter et måltid.
English: - Anxiety.
Danish: - Galdestensanfald.
English: What you need to know before you take alli Do not take alli
Danish: Det skal du vide, før du begynder at tage alli Tag ikke alli
English: How to set your fat target
Danish: Sådan fastsætter du fedtmålet
English: The fat gram target chart follows the information below on setting your calorie target.
Danish: Tabellen for dit fedtmål følger efter informationen, om hvordan du bestemmer dit kaloriemål.
English: alli should be used along with a reduced calorie, lower-fat diet.
Danish: alli anvendes til vægttab kombineret med en kalorie- og fedtfattig kost.
English: - If you are taking ciclosporin, used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions.
Danish: - tager ciclosporin, som anvendes efter organtransplantation, ved leddegigt og visse hudsygdomme.
English: Symptoms may include severe abdominal pain sometimes radiating towards the back, possibly with fever, nausea and vomiting.
Danish: Symptomerne kan omfatte svære mavesmerter, som kan stråle ud mod ryggen, og kan være ledsaget af feber, kvalme og opkastning.
English: - if you are taking a thyroid medicine (levothyroxine).
Danish: - tager medicin for sygdomme i skoldbruskkirtlen (levothyroxin).
English: Each hard capsule contains 60 mg of orlistat.
Danish: Hver hård kapsel indeholder 60 mg orlistat.
English: Indigo carmine (E132) Titanium dioxide (E171) Sodium laurilsulfate Sorbitan monolaurate
Danish: Indigotin I (E132) Titandioxid (E171) Natriumlaurilsulfat Sorbitanmonolaurat
English: • you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime.
Danish: • Tag 1 multivitaminpille (med vitamin A, D, E og K) hver dag ved sengetid.
English: Lost ≥10% of baseline body weight
Danish: Tab ≥10 % af udgangsvægt (%)
English: Contents of the pack and other information - What alli contains - What alli looks like and contents of the pack - Marketing Authorisation Holder and Manufacturer - Further helpful information
Danish: Pakningsstørrelser og yderligere oplysninger alli indeholder allis udseende og pakningsstørrelser Indehaver af markedsføringstilladelse og fremstiller Flere nyttige oplysninger
English: Contents of the pack and other information - What alli contains - What alli looks like and contents of the pack - Marketing authorisation holder and manufacturer - Further helpful information
Danish: Pakningsstørrelse og yderligere oplysninger alli indeholder allis udseende og pakningsstørrelser Indehaver af markedsføringstilladelse og fremstiller Flere nyttige oplysninger
English: alli can be taken immediately before, during a meal or up to one hour after a meal.
Danish: alli kan tages lige inden et måltid, under eller op til én time efter et måltid.
English: INFORMATION IN BRAILLE alli 60 mg hard capsules
Danish: INFORMATION I BRAILLESKRIFT alli 60 mg hårde kapsler
English: Talk to your doctor before taking alli
Danish: Tal med lægen, før du tager alli, hvis du
English: - Distribute your fat allowance evenly across your meals for the day.
Danish: - Fordel den tilladte mængde fedt jævnt mellem dagens måltider.
English: • if you are taking a medicine for high cholesterol.
Danish: • medicin mod for højt kolesterol.
English: България ГлаксоСмитКлайн Консюмър Хелткеър
Danish: ГлаксоСмитКлайн Консюмър Хелткеър Teл.
English: • if you have problems absorbing food (chronic malabsorption syndrome).
Danish: • har problemer med at optage næring fra føden (kronisk malabsorptionssyndrom).
English: Indigo carmine (E132)
Danish: Indigotin I (E132)
English: Patients who are taking amiodarone should consult a doctor before starting treatment with alli (see section 4.5).
Danish: Patienter, som tager amiodaron, bør konsultere en læge inden behandlingen med alli (se pkt.
English: Women of childbearing potential / Contraception in males and females 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 sections 4.4 and 4.5).
Danish: Kvinder i den fertile alder/Kontraception til mænd og kvinder Brug af supplerende præventionsmetode anbefales for at forhindre at oralt kontraceptiva evt. ikke virker, som f.eks. i tilfælde af svær diarré (se pkt.
English: Keep the container tightly closed in order to protect from moisture.
Danish: Hold beholderen tæt tillukket for at beskytte mod fugt.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information findes på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu.
English: Learn to deal with alli effects-related to your diet or fat intake
Danish: Lær at håndtere alli-gener, der skyldes din kost eller dit fedtindtag
English: In the event of an overdose, medical advice should be sought.
Danish: I tilfælde af overdosering skal patienten rådføre sig med en læge.
English: Package leaflet: Information for the user alli 60 mg hard capsules Orlistat
Danish: Indlægsseddel: Information til brugeren alli 60 mg hårde kapsler Orlistat
English: - if you have kidney disease.
Danish: - Hvis du har en nyresygdom.
English: Common side effects - Effects seen in blood tests - Learn to deal with diet-related treatment effects How to store alli
Danish: Virkninger, der kan ses i blodprøver Lær at håndtere gener, der skyldes kosten Opbevaring
English: - if you are taking a medicine for high cholesterol.
Danish: - medicin mod for højt kolesterol.
English: The effect of orlistat in individuals with hepatic and/or renal impairment has not been studied (see section 4.4).
Danish: Effekten af orlistat er ikke undersøgt hos patienter med nedsat lever- og/eller nyrefunktion (se pkt.
English: • take one capsule whole with water, three times a day with each main meal containing fat.
Danish: • Tag 1 hel kapsel med et glas vand 3 gange dagligt ved hvert fedtholdigt hovedmåltid.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 60 mg orlistat.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder 60 mg orlistat.
English: alli is available in pack sizes of 42, 60, 84, 90 and 120 capsules.
Danish: alli fås i pakninger med 42, 60, 84, 90 eller 120 kapsler.
English: - If you are pregnant or breast-feeding.
Danish: - er gravid eller ammer.
English: How to take alli
Danish: Sådan skal du tage alli
English: - Pancreatitis (inflammation of the pancreas).
Danish: - Betændelse i bugspytkirtlen (pancreatitis).
English: Men Low activity
Danish: Mænd Lavt aktivitetsniveau
English: Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal reactions (see section 4.4).
Danish: Indtagelse af fedtfattig kost gør det muligt at nedsætte sandsynligheden for at få gastrointestinale bivirkninger (se pkt.
English: The tablets work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed.
Danish: Tabletterne virker i fordøjelsessystemet, hvor de forhindrer kroppen i at optage omkring en fjerdedel af fedtet fra kosten.
English: - you should take a multivitamin (containing vitamins A, D, E and K) once a day, at bedtime.
Danish: - Tag 1 multivitaminpille (med vitamin A, D, E og K) hver dag ved sengetid.
English: The tablet should be chewed immediately before, during or up to 1 hour after each main meal.
Danish: Tabletten skal tygges umiddelbart før, under eller op til 1 time efter hvert hovedmåltid.
English: If you miss taking a capsule: - If it is less than an hour since your last main meal, take the missed capsule.
Danish: Hvis du kommer til at springe en kapsel over: - Tag den glemte kapsel, hvis der er gået under en time siden sidste hovedmåltid.
English: Marketing Authorisation Holder: GlaxoSmithKline Dungarvan Limited, Knockbrack,
Danish: Indehaver af markedsføringstilladelsen: GlaxoSmithKline Dungarvan Limited, Knockbrack,
English: The capsules work only in your digestive system to stop about a quarter of the fat in your meals from being absorbed.
Danish: Kapslerne virker i fordøjelsessystemet, hvor de forhindrer kroppen i at optage omkring en fjerdedel af fedtet fra kosten.
English: 74.8 kg to 83.9 kg
Danish: 74,8 kg til 83,9 kg
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, skal man ikke tage en dosis orlistat.
English: Plasma concentrations of intact orlistat were non-measurable (<5 ng/ml) 8 hours following oral administration of orlistat 360 mg.
Danish: 8 timer efter oral indgift af 360 mg orlistat kune der ikke måles plasmakoncentrationer (< 5 ng/ml) af intakt orlistat.
English: • if you are taking medicines for HIV.
Danish: • tager medicin mod HIV.
English: - Eat lower-fat meals to reduce the chance of diet-related treatment effects (see section 4).
Danish: - Spis fedtfattigt for at nedsætte sandsynligheden for gener forbundet med kosten (se punkt 4).
English: If you have taken too many capsules, contact a doctor as soon as possible.
Danish: Kontakt omgående en læge, hvis du har taget for mange kapsler.
English: Taking alli means your body will pass more fat through, and therefore may struggle to cope with eating as much fat as before.
Danish: Din krop vil derfor måske få problemer med at omsætte samme fedtindtag som tidligere.
English: Each chewable tablet contains 27 mg of orlistat.
Danish: Hver tyggetablet indeholder 27 mg orlistat.
English: EU/1/07/401/012-016
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/07/401/012-016
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 27 mg orlistat.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tyggetablet indeholder 27 mg orlistat.
English: - if you have problems absorbing food (chronic malabsorption syndrome).
Danish: - har problemer med at optage næring fra føden (kronisk malabsorptionssyndrom).
English: NAME OF THE MEDICINAL PRODUCT alli 60 mg hard capsules
Danish: LÆGEMIDLETS NAVN alli 60 mg hårde kapsler
English: Package leaflet: Information for the user alli 27 mg chewable tablets Orlistat
Danish: Indlægsseddel: Information til brugeren alli 27 mg tyggetabletter Orlistat
English: Orlistat may potentially reduce the absorption of antiretroviral medicinal products for HIV and could negatively affect the efficacy of antiretroviral medicinal products for HIV (see section 4.5).
Danish: Orlistat kan muligvis reducere absorptionen af antiretrovirale lægemidler mod HIV og dermed påvirke effekten af antiretrovirale lægemidler negativt (se pkt.
English: alli is clinically proven to help you lose more weight than dieting alone.
Danish: Det er klinisk dokumenteret, at alli kan hjælpe dig med at tabe mere vægt end diæt alene.