FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are under 18 years old.
Danish: • er under 18 år.
English: If you weigh less than the weight shown for your height, your BMI is below 28 - do not use alli.
Danish: Hvis du vejer mindre end den vægt, der er angivet ud for din højde, er dit BMI under 28 - tag ikke alli.
English: Try to start this diet before beginning treatment.
Danish: Forsøg at indlede denne diæt, før du begynder på behandlingen.
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 (hovedsageligt lipoproteiner og albumin).
English: Cases of rectal bleeding have been reported in patients taking orlistat.
Danish: Der er rapporteret om tilfælde af rektal blødning, hos patienter som tager orlistat.
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: Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger på graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Make every effort to avoid any high-fat meals while taking alli.
Danish: Gør dig derfor umage for at undgå måltider med meget højt fedtindhold, mens du tager alli.
English: The capsule should be swallowed with water.
Danish: Kapslen skal sluges hel med vand.
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 kontraceptiva og dermed i enkelte tilfælde føre til uventede graviditeter.
English: The chart below will help you find out whether you are overweight and whether alli is right for you.
Danish: Se skemaet nedenfor for at tjekke om du er overvægtig, og om alli er det rette for dig.
English: Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.
Danish: Baseret på humane undersøgelser og dyreundersøgelser bør de systemiske virkninger, der kan tillægges orlistats lipasehæmmende egenskaber, være hurtigt reversible.
English: You should plan to have three meals per day.
Danish: Du bør planlægge ud fra 3 daglige måltider.
English: The medicinal use of orlistat is unlikely to represent a risk to the aquatic or terrestrial environment.
Danish: Det er usandsynligt at den medicinske anvendelse af orlistat udgør en risiko for vandmiljøet eller landmiljøet.
English: It is recommended that a diet and exercise programme is started before beginning treatment with alli.
Danish: Det anbefales at starte et kost- og motionsprogram før indledning af behandling med alli.
English: The frequencies of adverse reactions identified during post-marketing use of orlistat are not known as these reactions were reported voluntarily from a population of uncertain size.
Danish: Hyppigheden af de bivirkninger, der blev påvist efter markedsføring af orlistat, er ikke kendt, da disse reaktioner er baseret på frivillige indberetninger fra en population af ukendt størrelse.
English: - Stick to realistic calorie and fat targets as this is a good way of maintaining your weight loss achievements in the long-term.
Danish: - Fastsæt realistiske mål for kalorier og fedt, da det gør det lettere at fastholde vægttabet på længere sigt.
English: Comparison versus placebo: a p<0.001; b p<0.01
Danish: Sammenligning med placebo: a p<0,001; b p<0,01
English: The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides.
Danish: Det inaktiverede enzym er således ikke tilgængeligt til at hydrolysere triglycerider fra fedt i kosten til absorberbare frie fedtsyrer og monoglycerider.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to fertility, reproduction and development.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af farmakologisk sikkerhed, toksicitet ved gentagne doseringer, genotoksicitet, karcinogenicitet, fertilitets- og reproduktionstoksicitet og udvikling.
English: You will need to know your activity level to set your calorie targets.
Danish: Det er vigtigt, at du kender dit aktivitetsniveau for at kunne sætte dit kaloriemål.
English: The volume of distribution cannot be determined because the active substance 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: • Chronic malabsorption syndrome
Danish: • Kronisk malabsorptionssyndrom
English: Do not “save up” fat and calorie allowances and then splurge on a high-fat meal or dessert, as you may have done on other weight loss programmes.
Danish: Lad være med at “opspare” fedt og kalorier, for så at fråse med hele den tilladte mængde i et fedtholdigt måltid eller en dessert, som du måske har gjort under andre vægttabsprogrammer.
English: A realistic goal is to lose between 5% to 10% of your starting weight.
Danish: Et realistisk mål for dit vægttab vil være 5-10 % af din startvægt.
English: C. A. Papaellinas Ltd,
Danish: C. A. Papaellinas Ltd, Τ.Θ.
English: If you miss taking a tablet:
Danish: Hvis du kommer til at springe en tablet over:
English: EXP In the carry case: 1 month
Danish: EXP I etuiet: 1 måned
English: In addition, doses of 240 mg three times daily 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: The weight loss induced by orlistat 60 mg conferred other important health benefits after 6 months of treatment in addition to weight loss.
Danish: Vægttabet induceret af orlistat 60 mg medførte andre vigtige sundhedsmæssige fordele efter 6 måneders behandling ud over selve vægttabet.
English: The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies.
Danish: Fravær af interaktion mellem orale kontraceptiva og orlistat er påvist i specifikke interaktionsstudier.
English: - You should aim to lose weight gradually and steadily.
Danish: - Du bør sigte efter at tabe dig gradvist og i et jævnt tempo.
English: If you eat a high-fat meal, do not take more than the recommended dose.
Danish: Selv om du spiser et måltid med højt fedtindhold, må du ikke tage mere end den anbefalede dosis.
English: Adverse reactions are listed below by system organ class and frequency.
Danish: Bivirkningerne er anført nedenfor, ordnet efter systemorganklasse og hyppighed.
English: - Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”.
Danish: - Brug ikke alli efter den udløbsdato, der står på pakningen og beholderen efter ”EXP”.
English: alli does not work unless there is some fat in the meal.
Danish: alli virker ikke, medmindre maden har et vist fedtindhold.
English: Pharmacotherapeutic group: antiobesity preparations, excl. diet products, peripherally acting antiobesity products, ATC code A08AB01.
Danish: Farmakoterapeutisk gruppe: Antiobesitaspræparater, undtaget diætprodukter, perifert virkende antiobesitasmiddel, ATC-kode A08AB01.
English: It is not known how frequently these effects occur (frequency cannot be estimated from the available data) - Increases in the levels of some liver enzymes.
Danish: Hyppigheden af disse bivirkninger kendes ikke (hyppigheden kan ikke estimeres ud fra forhåndenværende data) - Forhøjede værdier for nogle leverenzymer.
English: Diet and exercise are important parts of a weight loss programme.
Danish: Kost og motion er vigtige elementer i et vægttabsprogram.
English: Keep a record of what you are eating in a food diary.
Danish: Før dagbog over hvad du spiser.
English: The dose of amiodarone may need to be adjusted during treatment with alli.
Danish: Doseringen af amiodaron skal måske justeres under behandling med alli.
English: The following table has been worked out so that it gives you a calorie target that is about 500 calories fewer per day than your body needs to maintain your current weight.
Danish: Den efterfølgende tabel er udregnet så den giver dig et kaloriemål, der ligger ca. 500 kalorier under det, din krop behøver for at bibeholde din nuværende vægt.
English: Physical activity is an important part of a weight loss programme.
Danish: Motion er en vigtig del af et vægttabsprogram.
English: Serious side effects It is not known how frequently these side effects occur
Danish: Alvorlige bivirkninger Hyppigheden af disse bivirkninger kendes ikke.
English: Tell your doctor or pharmacist if any of these side effects gets severe or troublesome.
Danish: Fortæl det til din læge eller apoteket, hvis en af disse bivirkninger bliver alvorlig eller generende.
English: Understanding the importance of calorie and fat targets
Danish: Forstå vigtigheden af kalorier og fedtmål
English: - Find out more about how much fat your favourite foods typically contain, and the size of your portions.
Danish: - Sæt dig ind i hvor meget fedt dine yndlingsretter typisk indeholder i den portionsstørrelse, du plejer at spise.
English: It is possible that the systemic absorption from 27 mg chewable tablets may be higher than that from 60 mg hard capsules.
Danish: Det er muligt at den systemiske optagelse af 27 mg tyggetabletter kan være højere end fra 60 mg hårde kapsler.
English: Other serious side effects - Bleeding from the back passage (rectum).
Danish: Andre alvorlige bivirkninger - Blødning fra endetarmen (rektum).
English: Talk to your doctor about your risk of developing these conditions.
Danish: Tal med din læge om, hvilken risiko du har for at få disse lidelser.
English: M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1,000and 2,500-fold less than orlistat, respectively).
Danish: M1 og M3 har en åben beta-laktonring med en yderst svag lipasehæmmende aktivitet (1000 henholdsvis 2500 gange mindre end orlistat).
English: Adults 18 and over - Take one capsule, three times a day.
Danish: Voksne (18 år og derover) - Tag 1 kapsel 3 gange dagligt.
English: The gastrointestinal adverse reactions identified from clinical trials with orlistat 60 mg of 18 months to 2 years duration were generally mild and transient.
Danish: De gastrointestinale bivirkninger, der blev påvist i kliniske undersøgelser af orlistat 60 mg med en varighed på 18 måneder til 2 år, var generelt lette og forbigående.
English: Fat-soluble vitamins
Danish: Fedtopløselige vitaminer
English: Losing weight and maintaining weight loss, for example by improving your diet and increasing your physical activity, can help reduce the risk of serious health problems and help improve your health.
Danish: Ved at tabe dig og fastholde vægttabet - for eksempel ved at spise sundere og dyrke mere motion - kan du nedsætte risikoen for alvorlige sundhedsproblemer og derved opnå et bedre helbred.
English: Orlistat, M1 and M3 are all subject to biliary excretion.
Danish: Orlistat, M1 og M3 udskilles alle i galden.
English: Risk of being overweight
Danish: Risikoen ved at veje for meget
English: Maximum amount of fat allowed per meal
Danish: Maksimal mængde fedt pr. måltid
English: alli is contraindicated in pregnancy (see section 4.3).
Danish: alli er kontraindiceret under graviditet (se pkt.
English: The amount of weight you lose may vary from week to week.
Danish: Det kan variere fra uge til uge, hvor meget du taber dig.
English: For adults with a BMI of 28 or above
Danish: Til voksne med et BMI på 28 eller derover.
English: Most of the common side effects related to alli (for example, wind with or without oily spotting, sudden or more frequent bowel motions and soft stools) are caused by the way it works (see section 1).
Danish: De fleste almindelige bivirkninger ved alli (f.eks. luftafgang fra tarmene med eller uden olieholdigt indhold, pludselig eller hyppig trang til afføring og løs afføring) skyldes medicinens virkemåde (se punkt 1).
English: Eating fewer than 1200 calories per day is not recommended.
Danish: Du bør ikke spise mindre end 1200 kalorier om dagen.
English: Some fatal cases or cases requiring liver transplantation have been reported.
Danish: Der er rapporteret dødelige tilfælde og tilfælde, som krævede levertransplantation.
English: alli 27 mg chewable tablets: Medicinal product not subject to medical prescription.
Danish: alli 27 mg tyggetabletter: Lægemidlet er ikke receptpligtigt.
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 lave lipasehæmmende aktivitet og de lave plasmaniveauer ved terapeutiske doser (i gennemsnit henholdsvis 26 ng/ml og 108 ng/ml) anses disse metabolitter for at være uden farmakologisk betydning.
English: For orlistat, no clinical data on exposed pregnancies are available.
Danish: Der foreligger ikke kliniske data for orlistat om eksponering under graviditet.
English: Mean change (kg)
Danish: Middeldifference (kg)
English: For further advice see Further helpful information in the blue pages in section 6.
Danish: Du kan få yderligere råd i punkt 6 under Flere nyttige oplysninger på de blå sider.
English: Amount of calories you can eat per day
Danish: Mængde kalorier du må få om dagen
English: Increase in transaminases and in alkaline phosphatase
Danish: Forhøjede værdier af aminotransferaser og alkalisk fosfatase
English: The alli website (please refer to your country specific website included in the list of local representatives above) provides you with a range of interactive tools, lower-fat recipes, physical activity tips and other useful information to help you lead a healthy life and to support you in meeting your weight loss goals.
Danish: På allis hjemmeside (find din landsspecifikke hjemmeside på listen over lokale repræsentanter herover) kan du finde en række interaktive værktøjer, opskrifter på fedtfattig mad, gode råd om motion og andre nyttige oplysninger, der kan hjælpe dig med at få en sundere livsstil og støtte dig i at nå dine vægtmål.
English: Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic medicinal products e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded.
Danish: Krampeanfald er rapporteret hos patienter, der er blevet behandlet samtidigt med orlistat og antiepileptika såsom valproat, lamotrigin, for hvilke en årsagssammenhæng med en interaktion ikke kan udelukkes.
English: Study 1
Danish: Forsøg 1
English: The safety and efficacy of alli in children below 18 years of age has not been established.
Danish: Alli's sikkerhed og virkning hos børn under 18 år er ikke fastlagt.
English: Moderate activity
Danish: Moderat aktivitetsniveau
English: Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall.
Danish: Dyreforsøg viser, at det er sandsynligt, at orlistats metabolisme hovedsageligt finder sted i mavetarmkanalens vægge.
English: Remember to check with your doctor first if you have not exercised before.
Danish: Tal først med din læge, hvis du ikke tidligere har dyrket motion.
English: Antidepressants, antipsychotics (including lithium) and benzodiazepines There are some case reports of reduced efficacy of antidepressants, antipsychotics (including lithium) and benzodiazepines coincidental to the initiation of orlistat treatment in previously well controlled patients.
Danish: Antidepressiva, antipsykotika (inklusive lithium) og benzodiazepiner Der er hos tidligere velbehandlede patienter rapporteret tilfælde af nedsat virkning af antidepressiva, antipsykotika (inklusive lithium) og benzodiazepiner ved start af behandling med orlistat.
English: If this occurs, consideration could be given to administering orlistat and antiepileptic medicinal products at different times (see section 4.5).
Danish: I så fald bør det overvejes at give orlistat og antiepileptika på forskellige tidspunkter (se pkt.
English: Women Low activity
Danish: Kvinder Lavt aktivitetsniveau
English: Food diaries are effective, because they make you aware of what you are eating, how much you eat, and give you the basis to make changes.
Danish: Det er effektivt at føre dagbog over kosten, fordi du så bliver opmærksom på, hvad og hvor meget du spiser, og dagbogen giver dig et grundlag at basere dine kostændringer på.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product not subject to medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Ikke receptpligtigt lægemiddel.
English: From clinical studies, it has been estimated that orlistat 60 mg taken three times daily blocks the absorption of approximately 25% of dietary fat.
Danish: Ud fra kliniske forsøg antages det, at når orlistat 60 mg tages tre gange dagligt, blokeres optagelsen af ca. 25 % af fedtet i kosten.
English: Losing around 0.5 kg (1 lb) per week is ideal.
Danish: Et vægttab på 0,5 kg pr. uge er ideelt.
English: It is important that you consult your doctor before taking alli if you are receiving treatment for HIV.
Danish: Det er vigtigt, at du taler med din læge, før du tager alli, hvis du får behandling mod HIV.
English: Talk to your doctor or pharmacist when taking alli - If you are taking a medicine for high blood pressure as it may be necessary to adjust your dose.
Danish: Tal med lægen eller apoteket, hvis du tager alli sammen med - medicin mod forhøjet blodtryk, da du måske skal have justeret din dosis.
English: Abdominal pain Faecal incontinence Liquid stools Increased defaecation
Danish: Abdominalsmerter Fækal inkontinens Tynd afføring Øget defækation
English: Adverse reactions to orlistat are largely gastrointestinal in nature and related to the pharmacologic effect of the medicinal product on preventing the absorption of ingested fat.
Danish: Bivirkningerne ved orlistat er hovedsageligt gastrointestinale og relaterer til lægemidlets farmakologiske effekt med hensyn til at forebygge absorptionen af indtaget fedt.
English: Upon discontinuation of therapy, faecal fat content returns to pre-treatment levels, usually 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: White to off-white, faceted, triangular shaped tablets of 12 mm, debossed with “alli”.
Danish: Hvide til off-white, facetterede, trekantede tabletter på 12 mm, præget med ”alli”.
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 observeret fald i plasmakoncentrationen af ciclosporin i et lægemiddelinteraktionsstudie og i flere tilfælde, når orlistat blev administreret samtidig.
English: Severe allergic reactions - Signs of a severe allergic reaction include: severe breathing difficulties, sweating, rash, itching, swollen face, rapid heart beat, collapse.
Danish: Alvorlige allergiske reaktioner - Symptomerne på en alvorlig allergisk reaktion omfatter svære vejrtrækningsproblemer, sved, udslæt, kløe, hævet ansigt, hurtig puls og besvimelse.
English: Study 2
Danish: Forsøg 2
English: Name and address of the manufacturer(s) responsible for batch release alli 60 mg hard capsules: Famar S.A., 48 KM Athens-Lamia, 190 11 Avlona, Greece alli 27 mg chewable tablets: Famar S.A., 49 KM Athens-Lamia, 190 11 Avlona, Greece
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse alli 60 mg hårde kapsler: Famar S.A., 48 KM Athens-Lamia, 190 11 Avlona, Grækenland alli 27 mg tyggetabletter: Famar S.A., 49 KM Athens-Lamia, 190 11 Avlona, Grækenland
English: Pooled data
Danish: Poolede data
English: Hypersensitivity reactions including anaphylaxis, bronchospasm, angioedema, pruritus, rash, and urticaria
Danish: Overfølsomhedsreaktioner inklusive anafylaksi, bronkospasme, angioødem, pruritus, udslæt og urticaria
English: A polystyrene resin/polyurethane carry case (shuttle) which can hold 3 tablets is included in each pack.
Danish: Et etui af polystyrenresin/polyurethan (shuttle), der kan indeholde 3 tabletter, er inkluderet i hver pakning.
English: If patients have been unable to lose weight after 12 weeks of treatment with alli, they should consult their doctor or a pharmacist.
Danish: Patienter, der ikke har tabt sig efter 12 ugers behandling med alli, bør konsultere lægen eller apoteket.
English: Capsule band Gelatin
Danish: Kapselskal Gelatine
English: Adults 18 and over - Chew one tablet, three times a day.
Danish: Voksne (18 år og derover) - Tyg 1 tablet 3 gange dagligt.
English: Pharmacodynamic equivalence of alli 27 mg chewable tablets and alli 60 mg hard capsules has been established using a faecal fat excretion model.
Danish: Den farmakodynamiske ekvivalens mellem alli 27 mg tyggetabletter og alli 60 mg hårde kapsler er blevet fastslået ved brug af en fækal fedtekskretionsmodel.
English: - You can keep your daily dose of alli in the blue carry case (shuttle) included in this pack.
Danish: - Du kan opbevare din daglige dosis alli i det blå etui (shuttle), der følger med pakningen.
English: A polystyrene resin / polyurethane carry case (shuttle) which can hold 3 capsules is included in each pack.
Danish: Et etui af polystyrenresin/polyurethan (shuttle), der kan indeholde 3 kapsler, er inkluderet i hver pakning.
English: †It is plausible that treatment with orlistat can lead to anxiety in anticipation of or secondary to gastrointestinal adverse reactions.
Danish: † Det er sandsynligt, at behandling med orlistat kan føre til uro enten i forventning om eller som følge af gastrointestinale reaktioner.
English: The primary parameter, change in body weight from baseline (time of randomisation), was assessed for body weight over time (Table 1) and the percentage of subjects who lost ≥5% or ≥10% of body weight (Table 2).
Danish: Den primære parameter, vægtændring fra baseline (tidspunktet for randomisering), blev vurderet for kropsvægt over tid (tabel 1) og som procentdel af forsøgspersoner, der opnåede vægttab på ≥5 % eller ≥10 % af legemsvægten (tabel 2).
English: Your calorie target alone should allow you to lose weight at a gradual, steady pace of about 0.5 kg (1 lb) per week, without feeling frustrated or deprived.
Danish: Dit kaloriemål alene bør medføre et gradvist og jævnt vægttab på omkring 0,5 kg om ugen uden følelsen af frustration eller afsavn.
English: Medicinal products for hypertension or hypercholesterolaemia Weight loss may be accompanied by an improvement in blood pressure and cholesterol levels.
Danish: Lægemidler mod hypertension eller hyperkolesterolæmi Et vægttab kan være ledsaget af forbedring i blodtryk og kolesteroltal.
English: Take a multivitamin every day if you are taking alli - alli can lower the levels of some vitamins absorbed by your body.
Danish: Tag en multivitaminpille hver dag, hvis du tager alli - alli kan nedsætte den mængde vitaminer som kroppen normalt optager.
English: - The calorie target is the maximum number of calories you will eat each day.
Danish: - Kaloriemålet er det maksimale antal kalorier du bør spise hver dag.
English: The vast majority of subjects receiving up to 4 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 personer, som i kliniske undersøgelser fik behandling med orlistat i op til 4 år, havde A-, D-, E- og K- og betakarotenniveauer, som forblev inden for normalområdet.
English: Tell your doctor that you are taking alli when you have a blood test.
Danish: Fortæl din læge, at du bruger alli, hvis du skal have taget en blodprøve.