FrancophonIA/ELRC3.0 huggingface dataset:
English: Serum calcium-phosphorus ion product
Danish: Calcium-fosfat-ionprodukt i serum
English: High density polyethylene (HDPE) bottles, with a polypropylene cap and an induction seal.
Danish: 6.5 Emballagetype og pakningsstørrelser (HDPE)-flasker med en polypropylenhætte og induktionsforsegling.
English: • Dysphagia or swallowing disorders
Danish: • Dysfagi eller synkelidelser
English: Skin and subcutaneous tissue disorders Uncommon:
Danish: Hud og subkutane væv Ikke almindelige:
English: - swallowing problems - severe problems with stomach or bowel movement, such as constipation, ulcers in the stomach or the gut or haemorrhoids, since these problems may lead to increased risk of e.g. bleeding from the intestines - recent major stomach or bowel surgery - gall bladder obstruction - severe liver problems - seizures - recent history of inflammation of the membrane that forms the lining of the abdominal (tummy) cavity
Danish: - synkeproblemer - svære problemer med maven eller afføring, som f.eks. obstipation, mavesår eller tarmen eller hæmorider, da disse problemer kan medføre øget risiko for f.eks. blødning fra tarmene - nylig større operation i maven eller tarmen - obstruktion af blærehalsen - svære leverproblemer - anfald - nylige tilfælde af inflammation af membranen der omslutter bughulen (maven) (peritonit) - lavt albuminniveau (et protein) i dit blod.
English: Tel: +49 211 - 520 544 33
Danish: Tlf.: +49 211 - 520 544 33
English: In the first study, the mean serum phosphorus level was 2.33 mmol/L at baseline and 1.96 mmol/L (mean reduction by 0.36 mmol/L) at week 12 on a colestilan mean daily dose of 11.5 g. Similarly in the second study, the mean serum phosphorus level was 2.44 mmol/L at baseline and 1.94 mmol/L at week 12 (mean reduction by 0.50 mmol/L) on a colestilan mean daily dose of
Danish: I den første undersøgelse var fosfatniveauet i serum 2,33 mmol/l ved baseline og 1,96 mmol/l (middelreduktion på 0,36 mmol/l) ved uge 12 med en daglig dosis af colestilan på 11,5 g. På tilsvarende vis i den anden undersøgelse var fosfatniveauet i serum 2,44 mmol/l ved baseline og 1,94 mmol/l ved uge 12 (middelreduktion på 0,50 mmol/l) med en daglig dosis af colestilan på 13,1 g. Andelen af respondenter (enten en reduktion i serum fosfor ≤ 1,78 mmol/l og/eller en reduktion fra baseline ≥ 0,3 mmol / l) var 50,4 % og 43,8 %
English: In subjects with baseline HbA1c ≥7.0%, colestilan showed a reduction of between 0.36 to 1.38% at week 12 in the fixed-dose study, and by 0.94 and 0.91% at week 12 in the two flexible-dose studies.
Danish: Hos patienter med baseline HbA1c ≥ 7,0 % viste colestilan en reduktion mellem 0,36 til 1,38 % ved uge 12 i undersøgelsen med fast dosis og med 0,94 og 0,91 % ved uge 12 i to undersøgelser med fleksible doser.
English: Changes in the bile acid pool in the gastrointestinal tract have also been observed to lower serum glucose.
Danish: Ændringer af galdesyrerne i mave-tarm-kanalen kan også reducere glukose i serum.
English: Endocrine disorders Uncommon:
Danish: Det endokrine system Ikke almindelige:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 g colestilan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 1 g colestilan.
English: Infections and infestations Uncommon:
Danish: Infektioner og parasitære sygdomme Ikke almindelige:
English: BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
Danish: BindRen er til behandling af hyperfosfatæmi hos voksne patienter med kronisk nyresygdom (KNS) i stadium 5, der modtager hæmodialyse eller peritonealdialyse.
English: Take BindRen by mouth.
Danish: Tag BindRen oralt.
English: Nervous system disorders Uncommon:
Danish: Nervesystemet Ikke almindelige:
English: What you need to know before you take BindRen Do not take BindRen - if you are allergic to colestilan or any of the other ingredients of this medicine (listed in section 6) - if you have bowel obstruction (a blockage of your intestines)
Danish: Tag ikke BindRen - hvis du er overfølsom over for colestilan eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: - BindRen 2 g granules: each sachet contains 2 g of colestilan.
Danish: - BindRen 2 g granulat: hvert brev indeholder 2 g colestilan.
English: Each sachet contains 3 g of granules.
Danish: Hvert brev indeholder 3 g granulat.
English: - BindRen 3 g granules: each sachet contains 3 g of colestilan.
Danish: - BindRen 3 g granulat: hvert brev indeholder 3 g colestilan.
English: Purified water Hydroxypropylcellulose Silica, colloidal anhydrous Castor oil, hydrogenated
Danish: Renset vand hydroxypropylcellulose Silicium, vandfri kolloid Ricinusolie, hydrogeneret
English: EXPIRY DATE
Danish: UDLØBSDATO Anv.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 3 G GRANULES IN SACHETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON − 3 G GRANULATER I BREVE
English: Each sachet contains 2 g of granules.
Danish: Hvert brev indeholder 2 g granulat.
English: Muscle spasm, musculoskeletal pain, arthralgia, back pain, pain in extremities
Danish: Spasmer i muskler, muskuloskeletale smerter, ledsmerter, rygsmerter, smerte i ekstremiteter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 2 G GRANULES IN SACHETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON − 2 G GRANULATER I BREVE
English: NAME OF THE MARKETING AUTHORISATION HOLDER Mitsubishi Tanabe Pharma Europe Ltd.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Mitsubishi Tanabe Pharma Europe Ltd.
English: BindRen is indicated for use in patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis.
Danish: BindRen er indiceret til behandling af patienter med KNS i stadium 5, der modtager hæmodialyse eller peritonealdialyse.
English: The most serious adverse reactions were gastrointestinal haemorrhage (uncommon) and constipation (common).
Danish: De mest alvorlige bivirkninger var blødning fra mave-tarm-kanalen (ikke almindelig) og obstipation (almindelig).
English: General disorders and administration site conditions Uncommon:
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelige:
English: Fixed-dose study:
Danish: Undersøgelse med fast dosis:
English: BindRen contains colestilan.
Danish: BindRen indeholder colestilan.
English: NAME OF THE MEDICINAL PRODUCT BindRen 1 g film-coated tablets
Danish: LÆGEMIDLETS NAVN BindRen 1 g filmovertrukne tabletter
English: Serum phosphorus
Danish: Fosfat i serum
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET FOR 3 G GRANULES
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ÆSKE TIL 3 G GRANULATER
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET FOR 2 G GRANULES
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ÆSKE TIL 2 G GRANULATER
English: This medicine does not require any special storage conditions.
Danish: Dette lægemiddel kræver ikke nogen særlige opbevaringsbetingelser.
English: It is recommended that you take BindRen granules as one dose from the sachet with a small amount of water, at the time of a meal or directly after.
Danish: Det anbefales, at du tager BindRen-granulat som en dosis fra brevet med lidt vand.
English: NAME OF THE MEDICINAL PRODUCT BindRen 1 g film-coated tablets colestilan
Danish: LÆGEMIDLETS NAVN BindRen 1 g filmovertrukne tabletter colestilan
English: What BindRen looks like and contents of the pack
Danish: Udseende af BindRen og pakningsstørrelser
English: • Seizure disorders
Danish: • Galdevejsobstruktion
English: Marketing Authorisation Holder Mitsubishi Tanabe Pharma Europe Ltd. Dashwood House
Danish: Indehaver af markedsføringstilladelsen Mitsubishi Tanabe Pharma Europe Ltd. Dashwood House
English: INFORMATION IN BRAILLE BindRen 2 g granules
Danish: INFORMATION I BRAILLESKRIFT BindRen 2 g granulat
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 2 g colestilan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert brev indeholder 2 g colestilan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 1 g colestilan.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 1 g colestilan.
English: INFORMATION IN BRAILLE BindRen 3 g granules
Danish: INFORMATION I BRAILLESKRIFT BindRen 3 g granulat
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 3 g colestilan.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert brev indeholder 3 g colestilan.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE LABEL - FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE LABEL PÅ FLASKE FILMOVERTRUKNE TABLETTER
English: Serum uric acid
Danish: Urinsyre i serum
English: The daily dose of BindRen tablets should be taken in three equally divided doses with or immediately after meals with a sufficient amount of water to aid swallowing.
Danish: Den daglige dosis af BindRen-tabletter skal tages i tre lige store doser umiddelbart efter måltider med tilstrækkeligt vand, så det er nemmere at sluge dem. Opdelingen af den daglige dosis kan justeres efter lægens anbefaling, idet der tages hensyn til indtagelse af fosfat i kosten.
English: The daily dose of BindRen granules should be taken in three equally divided doses with or immediately after meals with a sufficient amount of water to aid swallowing.
Danish: Den daglige dosis af BindRen-granulater skal tages i tre lige store doser umiddelbart efter måltider med tilstrækkelig vand, så det er nemmere at sluge dem. Opdelingen af den daglige dosis kan justeres efter lægens anbefaling, idet der tages hensyn til indtagelse af fosfat i kosten.
English: How to store BindRen
Danish: Opbevaring af BindRen
English: Psychiatric disorders Uncommon:
Danish: Psykiske forstyrrelser Ikke almindelige:
English: Asthenia
Danish: Koronarsygdom
English: Blisters This medicine does not require any special storage conditions.
Danish: Blisterpakninger Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTERS - FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON FOR BLISTERPAKNINGER FILMOVERTRUKNE TABLETTER
English: • Bowel obstruction.
Danish: • Tarmobstruktion.
English: How to take BindRen
Danish: Sådan skal du tage BindRen
English: NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules colestilan
Danish: LÆGEMIDLETS NAVN BindRen 2 g granulat colestilan
English: Tremor, dizziness, headache, dysgeusia
Danish: Tremor, svimmelhed, hovedpine, ændret smagssans
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 2 g colestilan.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev indeholder 2 g colestilan.
English: NAME OF THE MEDICINAL PRODUCT BindRen 2 g granules
Danish: LÆGEMIDLETS NAVN BindRen 2 g granulat
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BOTTLES - FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON FOR FLASKER FILMOVERTRUKNE TABLETTER
English: NAME OF THE MEDICINAL PRODUCT BindRen 3 g granules colestilan
Danish: LÆGEMIDLETS NAVN BindRen 3 g granulat colestilan
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 3 g colestilan.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev indeholder 3 g colestilan.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION BindRen 2 g granules colestilan
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) BindRen 2 g granulat colestilan
English: NAME OF THE MEDICINAL PRODUCT BindRen 3 g granules
Danish: LÆGEMIDLETS NAVN BindRen 3 g granulat
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION BindRen 3 g granules colestilan
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) BindRen 3 g granulat colestilan
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/014-016
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/804/014-016
English: Musculoskeletal and connective tissue disorders Uncommon:
Danish: Knogler, led, muskler og bindevæv Ikke almindelige:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/001-005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/804/001-005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/011-013
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/804/011-013
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/006-010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/804/006-010
English: 45 film-coated tablets 99 film-coated tablets 198 film-coated tablets 270 film-coated tablets 297 film-coated tablets
Danish: 297 Filmovertrukne tabletter.
English: Vascular disorders Uncommon:
Danish: Vaskulære sygdomme Ikke almindelige:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/804/001-010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/804/001-010
English: • Severe gastrointestinal disorders such as chronic or severe constipation, intestinal stenosis, intestinal diverticulum, sigmoid colitis, gastrointestinal ulcers, or recent major gastrointestinal surgery
Danish: sigmoideum-kolit, gastrointestinale ulcerationer eller nylig større operation i mave-tarm-kanalen
English: Gastrointestinal haemorrhage, oesophagitis, faecaloma, dysphagia, change in bowel habit, dry mouth
Danish: Blødning fra mave-tarm-kanalen, øsofagit, fækulit, dysfagi, ændring i afføringsmønster, tør mund
English: Cardiac disorders Rare:
Danish: Hjerte Sjælden:
English: Granule core
Danish: Pakningsstørrelser:
English: (peritonitis) - low levels of albumin (a protein) in your blood
Danish: - hvis du har tarmobstruktion (en blokering i dine tarme).
English: Printing ink
Danish: Trykblæk
English: 26.3%, respectively).
Danish: henholdsvis i de to undersøgelser (placebo 30,8 % og 26,3 % henholdsvis).
English: Coronary artery disease
Danish: Blødning fra mave-tarm-kanalen
English: This summary was last updated in 06-2008.
Danish: Dette sammendrag blev sidst ajourført i 07-2008.
English: The marketing authorisation was renewed on 29 July 2003 and on 29 July 2008.
Danish: Markedsføringstilladelsen blev fornyet den 29. juli 2003 og den 29. juli 2008.
English: Neither the patients nor the doctors knew which treatment each patient was taking until the end of the study.
Danish: Hverken patienter eller læger vidste, hvilken behandling de enkelte patienter fik, indtil undersøgelsen var afsluttet.
English: It is available as turquoise capsules (120 mg).
Danish: Det leveres som turkise kapsler (120 mg).
English: These symptoms generally occur at the beginning of treatment, and go away after some time.
Danish: Disse symptomer opstår generelt i starten af behandlingen og forsvinder efter et stykke tid.
English: This helps weight reduction.
Danish: Dette bidrager til vægttab.
English: The patient should be on a diet in which about 30% of the calories come from fat, and which is rich in fruit and vegetables.
Danish: Patienten bør være på en diæt, hvor ca. 30 % af kalorierne kommer fra fedt, og som er rig på frugt og grøntsager.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xenical to Roche Registration Limited on 29 July 1998.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xenical til Roche Registration Limited den 29. juli 1998.
English: The effects of Xenical were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Xenical blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Xenical is given as one capsule taken with water just before, during, or up to one hour after each main meal.
Danish: Xenical tages som en kapsel med vand umiddelbart før, under eller op til en time efter hvert hovedmåltid.
English: Other information about Xenical:
Danish: Andre oplysninger om Xenical:
English: The body cannot use this dietary fat for energy or convert it into fat tissue.
Danish: Kroppen kan ikke anvende dette fedt som energikilde eller omdanne det til fedtvæv.
English: Treatment with Xenical should be stopped after 12 weeks if patients have been unable to lose at least 5% of their body weight since the start of treatment.
Danish: Behandling med Xenical bør ophøre efter 12 uger, hvis patienterne ikke har været i stand til at tabe mindst 5 % af deres legemsvægt siden starten af behandlingen.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) XENICAL EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) XENICAL EPAR - sammendrag for offentligheden
English: If a meal is missed or contains no fat, Xenical should not be taken.
Danish: Hvis et måltid springes over eller ikke indeholder fedt, skal man undlade at tage Xenical.
English: The Committee recommended that Xenical be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af en markedsføringstilladelse for Xenical.
English: In all studies, the main measure of effectiveness was the change in weight.
Danish: I samtlige undersøgelser blev behandlingens virkning hovedsagelig bedømt på ændringer i vægt.
English: Xenical is a medicine containing the active substance orlistat.
Danish: Xenical er et lægemiddel, som indeholder det aktive stof orlistat.
English: Xenical was more effective than placebo in producing a reduction in weight.
Danish: Xenical var mere effektivt end placebo med henblik på at fremkalde vægttab.
English: Xenical has been studied in seven main studies involving over 3,000 overweight or obese patients.
Danish: Xenical er blevet undersøgt i syv hovedundersøgelser, som omfattede over 3 000 overvægtige eller adipøse patienter.
English: The full EPAR for Xenical can be found here.
Danish: Den fuldstændige EPAR om Xenical findes her.
English: The active ingredient in Xenical, orlistat, is an anti-obesity medicine, which does not affect appetite.
Danish: Det aktive stof i Xenical, orlistat, er et lægemiddel mod fedme, som ikke påvirker appetitten.
English: When these enzymes are blocked, they cannot digest some fats in the diet, and this allows about 30% of the fat eaten in the meal to pass through the gut undigested.
Danish: Når disse enzymer blokeres, kan de ikke nedbryde alt fedt i kosten, hvilket medfører, at ca. 30 % af måltidets fedt passerer igennem tarmen uden at blive nedbrudt.
English: The proportion of patients losing 10% or more of their body weight was 20% in the patients taking this dose of Xenical and 8% in those taking placebo.
Danish: Andelen af patienter, der tabte 10 % eller mere af deres kropsvægt, var 20 % hos patienter, der fik denne dosis af Xenical, og 8 % hos patienter, der fik placebo.
English: The most common side effects with Xenical (seen in more than 1 patient in 10) are influenza (flu), hypoglycaemia (low blood sugar levels), headache, upper respiratory infection (colds), oily spotting from the rectum, abdominal (tummy) pain or discomfort, flatus (gas) with discharge, faecal urgency (urgent need to open the bowels), fatty or oily stools, flatulence (gas), liquid stools, oily evacuation (faeces) and increased defecation.
Danish: De hyppigste bivirkninger af Xenical (som ses hos flere end 1 ud af 10 patienter) er influenza, hypoglykæmi (lavt blodsukker), hovedpine, øvre luftvejsinfektioner (forkølelse), olielignende pletter fra endetarmen, mavesmerter eller abdominale gener, flatus (tarmluft) med udflåd, bydende defæktationstrang (pludselig, tvingende afføringstrang), fedtlignende eller olielignende afføring, flatulens (tarmluft), flydende afføring, olielignende udtømning (afføring) og øget defækation.
English: Xenical should not be used in people who may be hypersensitive (allergic) to orlistat or any of the other ingredients.
Danish: Xenical må ikke anvendes af patienter, der kan være overfølsomme (allergiske) over for orlistat eller andre af indholdsstofferne.
English: The studies lasted from one to two years and compared three different doses of Xenical with placebo (a dummy treatment), in combination with dieting.
Danish: Undersøgelserne varede fra et til to år og sammenlignede tre forskellige doser af Xenical med placebo (en virkningsløs behandling) i kombination med en diæt.
English: Orlistat blocks gastrointestinal lipases (enzymes that digest fat).
Danish: Orlistat blokerer lipaser i mavetarmkanalen (enzymer, der nedbryder fedt).
English: Why has Xenical been approved?
Danish: Hvorfor blev Xenical godkendt?
English: When the results from all seven shorter studies were taken together, patients taking 120 mg Xenical three times a day had an average fall of 6.1 kg in body weight after a year, compared with 2.6 kg in those taking placebo.
Danish: Sammenlagt viste resultaterne fra samtlige syv korte undersøgelser, at patienter, der fik 120 mg Xenical tre gange dagligt, havde mindsket deres kropsvægt med gennemsnitligt 1,6 kg efter et år sammenlignet med 2,6 kg for placebobehandlede patienter.
English: What is the risk associated with Xenical?
Danish: Hvilken risiko er der forbundet med Xenical?
English: At the end of the four-year study, 21% of the patients treated with Xenical had lost more than 10% of their body weight, compared with 10% of the patients who received placebo.
Danish: Efter afslutning af den fireårige undersøgelse havde 21 % af patienterne, behandlet med Xenical, mindsket mere end 10 % af deres kropsvægt sammenlignet med 10 % af de patienter, der fik placebo.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Xenical's benefits are greater than its risks in conjunction with a mildly hypocalorific diet for the treatment of obese patients with a BMI greater or equal to 30 kg/m2, or overweight patients (BMI ≥ 28 kg/m2) with associated risk factors.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Xenical er større end risiciene, i kombination med en mild lavkaloriediæt, til behandling af adipøse patienter med et BMI, der ligger over eller svarer til 30 kg/m2, eller overvægtige patienter (BMI ≥ 28 kg/m2) med hermed forbundne risikofaktorer.
English: Xenical is used together with dieting for the treatment of obese (very overweight) patients with a body mass index (BMI) greater than or equal to 30 kg per square metre, or overweight patients (BMI greater than or equal to 28 kg/m2) who are at risk of illness because of their weight.
Danish: Xenical anvendes sammen med diæt til behandling af adipøse (meget overvægtige) patienter med et kropsmasseindeks (BMI) større end eller lig med 30 kg pr. kvadratmeter, eller overvægtige patienter (BMI større end eller lig med28 kg/m²), som risikerer at blive syge på grund af overvægt.
English: The food in the diet should be spread over three main meals.
Danish: Den daglige indtagelse af fedt, kulhydrat og protein bør fordeles over 3 hovedmåltider.
English: What is Xenical?
Danish: Hvad er Xenical?
English: It should also not be used in people with a long-term malabsorption disease (where nutrients from the food are not easily absorbed during digestion), with cholestasis (a liver disorder) or who are breast-feeding.
Danish: Lægemidlet må heller ikke anvendes af personer, der har en kronisk malabsorptionssygdom (nedsat optagelse af næringsstoffer under fordøjelsen), har cholestatis (en leversygdom), eller som ammer.
English: For the full description of all side effects reported with Xenical, see the Package Leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Xenical fremgår af indlægssedlen.
English: What is Xenical used for?
Danish: Hvad anvendes Xenical til?
English: obese patients compared the effects of Xenical and placebo over four years, in combination with diet and exercise.
Danish: En supplerende, længere undersøgelse med deltagelse af over 3 000 adipøse patienter sammenlignede virkningerne af Xenical og placebo over en periode på fire år i kombination med diæt og motion.
English: How has Xenical been studied?
Danish: Hvordan blev Xenical undersøgt?
English: What benefit has Xenical shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Xenical?
English: How is Xenical used?
Danish: Hvordan anvendes Xenical?