FrancophonIA/ELRC3.0 huggingface dataset:
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har brugt det for nylig.
English: Headache, abdominal pain/discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, oily discharge, oily or fatty stools, liquid stools, low blood sugar levels (experienced by some people with type 2 diabetes).
Danish: Hovedpine, smerter/ubehag i maven, stærk trang til eller øget hyppighed af afføring, luftafgang med afføring, olieagtig afføring, olieret eller fedtet afføring, vandig afføring, lavt blodsukkerniveau (hos patienter med type 2-diabetes).
English: Antiepileptics patient: Orlistat may unbalance anticonvulsivant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions (see section 4.5).
Danish: Epilepsipatienter: Orlistat kan påvirke den antikonvulsive behandling ved at nedsætte absorptionen af antiepileptika, hvilket kan medføre kramper (se pkt.
English: - Cholestasis.
Danish: - Kolestase.
English: Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur.
Danish: Der kan i sjældne tilfælde forekomme hypotyroidisme og/eller dårligere kontrol af hypotyroidisme.
English: The great majority of diabetes cases came from the subgroup of patients with impaired glucose tolerance at baseline, which represented 21 % of the randomised patients.
Danish: Langt størstedelen af diabetestilfældene fandtes i den subgruppe af patienter, der havde forringet glucosetolerance ved studiets start.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter alvorlighed med den alvorligste bivirkning anført først.
English: Bullous eruptions
Danish: Bulløse udslæt
English: Studies in normal weight and obese subjects have shown that faecal excretion of the unabsorbed drug was the major route of elimination.
Danish: Studier hos normalvægtige og adipøse forsøgspersoner har vist, at den ikke-absorberede del af lægemidlet elimineres via fæces.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER PACKS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON FOR BLISTERPAKNINGER
English: Stop Xenical if such symptoms occur and tell your doctor.
Danish: Hvis du får disse symptomer, skal du stoppe med at tage Xenical og kontakte lægen.
English: The disposition of orlistat appeared to be similar between normal weight and obese volunteers.
Danish: Eliminationen af orlistat var tilsyneladende ens hos normalvægtige og adipøse forsøgspersoner.
English: In obese type 2 diabetic patients insufficiently controlled by antidiabetic agents, data from four oneyear clinical trials showed that the percentage of responders (≥ 10 % of body weight loss) was 11.3 % with orlistat as compared to 4.5 % with placebo.
Danish: Sammenlagte data fra fire 1-års kliniske forsøg med adipøse type 2-diabetespatienter, der var utilstrækkeligt kontrolleret med antidiabetika, viste, at procentdelen af respondenter (≥ 10 % tab af legemsvægt) var 11,3 % blandt dem, der fik orlistat sammenlignet med 4,5 % blandt dem, der fik placebo.
English: In the absence of a teratogenic effect in animals, no malformative effect is expected in man. To date, active substances responsible for malformations in man have been found teratogenic in animals when well-conducted studies were performed in two species.
Danish: I velgennemførte studier hos to arter har lægemidler, som forårsager medfødte misdannelser hos mennesker, til dato vist sig at være teratogene hos dyr.
English: 9.5 % of the orlistat treated patients versus 3.3 % of the placebo treated patients lost ≥ 10 % of body weight after 1 year with a mean difference of 2.6 kg between the two groups.
Danish: 9,5 % af de orlistatbehandlede patienter mod 3,3 % af de placebobehandlede patienter tabte ≥ 10 % af deres kropsvægt efter 1 år, og der var en middeldifference på 2,6 kg mellem de to grupper.
English: Rectal pain/discomfort Soft stools
Danish: Smerter og ubehag i rectum Blød afføring
English: Blister packs
Danish: Blisterpakning:
English: Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants (see section 4.5 and 4.8).
Danish: Koagulationsparametre bør monitoreres hos patienter, der samtidig bliver behandlet med antikoagulantia (se pkt.
English: After 4 years of treatment 21 % of the orlistat treated patients compared to 10 % of the placebo treated patients had lost ≥ 10 % of body weight, with a mean difference of 2.7 kg.
Danish: Efter 4 års behandling havde 21 % af de orlistatbehandlede patienter sammenlignet med 10 % af de placebobehandlede patienter tabt ≥ 10 % af kropsvægten med en middeldifference på 2,7 kg.
English: Do not store above 25 °C
Danish: Må ikke opbevares ved temperaturer over 25 °C
English: The capsule shell consists of gelatine, indigo carmine (E132), titanium dioxide (E171) and edible printing ink.
Danish: (E132), titandioxid (E171) og spiselig tryksværte.
English: After 1 year of treatment, 41 % of the orlistat treated patients versus 21 % of placebo treated patients lost ≥ 10 % of body weight with a mean difference of 4.4 kg between the two groups.
Danish: Efter et års behandling havde 41 % af de orlistatbehandlede patienter versus 21 % af de placebobehandlede patienter tabt ≥ 10 % af kropsvægten med en middeldifference på 4,4 kg mellem de to grupper.
English: Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded.
Danish: Hos patienter, der samtidig bliver behandlet med orlistat og antiepileptika f.eks. valproat og lamotrigin, er der rapporteret om tilfælde af kramper.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/071/004 21 capsules
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/98/071/004 21 kapsler
English: Medicines should not be disposed via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Xenical 120mg hard capsules Orlistat
Danish: Xenical 120 mg hårde kapsler Orlistat
English: NAME OF THE MEDICINAL PRODUCT Xenical 120 mg hard capsules
Danish: LÆGEMIDLETS NAVN Xenical 120 mg hårde kapsler
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.
Danish: En supplerende præventionsmetode anbefales på grund af risikoen for svigt af præventionsmidler indtaget gennem munden, hvilket kan forekomme i forbindelse med kraftig diarré.
English: Of these, 62 % of orlistat treated patients and 52 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Danish: Af disse fortsatte 62 % af de orlistatbehandlede patienter og 52 % af de placebobehandlede patienter i løbet af det første år med at tabe mere end 10 % af deres udgangskropsvægt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 120 mg orlistat.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 120 mg orlistat.
English: EU/1/98/071/006 84 capsules
Danish: EU/1/98/071/006 84 kapsler
English: Acarbose
Danish: Galdesten
English: Fat soluble vitamins
Danish: Fedtopløselige vitaminer
English: Orlistat may unbalance an anticonvulsivant treatment, by decreasing the absorption of antiepileptic drugs, thus leading to convulsions.
Danish: Orlistat kan påvirke behandlingen af kramper ved at nedsætte optagelsen af medicin, der anvendes til behandling af epilepsi.
English: Of these, 49 % of orlistat treated patients and 40 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Danish: Af disse, fortsatte 49 % af orlistatpatienterne og 40 % af placebopatienterne med at tabe ≥ 10 % af udgangskropsvægten efter 1 års behandling.
English: EU/1/98/071/005 42 capsules
Danish: EU/1/98/071/005 42 kapsler
English: Keep the container tightly closed in order to protect from moisture.
Danish: Opbevar pakningen tæt lukket for at beskytte mod fugt.
English: Co-administration with ciclosporin is not recommended.
Danish: Det kan ikke anbefales at indtage ciclosporin sammen med Xenical.
English: You must not breast-feed your infant during treatment with Xenical as it is not known whether Xenical passes into human milk.
Danish: Det vides ikke, om Xenical går over i mælken hos mennesker.
English: Therefore the combination is not recommended (see section 4.4).
Danish: Samtidig administration frarådes derfor (se pkt.
English: In patients receiving concomitant amiodarone treatment, reinforcement of clinical and ECG monitoring is warranted.
Danish: For patienter, der bliver behandlet med amiodaron og orlistat samtidig, er det særlig vigtigt at foretage klinisk monitorering, inkl.
English: • Anticoagulant drugs (e.g. warfarin).
Danish: • Medicin der forhindrer blodet i at størkne (koagulation, f.eks. warfarin).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 July 1998
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Conversely, of patients failing to demonstrate a loss of 5 % of their baseline body weight after 12 weeks of treatment, only 5 % of orlistat treated patients and 2 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Danish: Af de patienter, som ikke opnåede et vægttab på over 5 % efter 12 uger, var der derimod kun 5 % af de orlistatbehandlede patienter og 2 % af placebobehandlede patienter, der tabte ≥ 10 % af deres udgangskropsvægt efter 1 års behandling.
English: If you have further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Er du i tvivl om, så spørg lægen eller på apoteket.
English: • The other ingredients are microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone (E1201), sodium laurilsulfate and talc.
Danish: • Øvrige indholdsstoffer: Mikrokrystallinsk cellulose (E460), natriumstivelsesglycolat (type A),
English: Conversely, of patients failing to demonstrate a loss of 5 % of their baseline body weight after 12 weeks of treatment, only 5 % of orlistat treated patients and 4 % of placebo treated patients went on to lose ≥ 10 % of their baseline body weight at one year.
Danish: Blandt de patienter, som ikke opnåede et vægttab på over 5 % efter 12 uger, var der derimod kun 5 % af de orlistatbehandlede patienter og 4 % af de placebobehandlede patienter, der tabte mere end 10 % af deres udgangskropsvægt efter 1 års behandling.
English: Metabolism and nutrition disorders Very common: Hypoglycemia*
Danish: Meget almindelig: Hypoglykæmi* Infektioner og parasitære sygdomme
English: The difference was driven by the outcome in the group of patients with ≥ 5 % weight loss after 12 weeks of treatment with orlistat representing 19 % of the initial population.
Danish: vægttab efter 12 ugers behandling, hvilket svarede til 19 % af den initiale population.
English: NAME OF THE MEDICINAL PRODUCT Xenical 120 mg hard capsules Orlistat
Danish: LÆGEMIDLETS NAVN Xenical 120 mg hårde kapsler Orlistat
English: What Xenical is and what it is used for What you need to know before you take Xenical How to take Xenical
Danish: Det skal du vide, før du begynder at tage Xenical Sådan skal du tage Xenical Bivirkninger
English: How to take XENICAL
Danish: Sådan skal du tage XENICAL
English: More patients on orlistat or placebo lost baseline body weight of at least 5 % at 12 weeks or 10 % at one year in the XENDOS study than in the five 2-year studies.
Danish: Flere patienter i XENDOS studiet end i de fem 2-årige studier, som enten blev behandlet med orlistat eller placebo, havde efter 12 uger tabt mindst 5 % eller havde efter 1 år tabt mindst 10 % af deres udgangsvægt.
English: Diverticulitis.
Danish: Galdesten.
English: If you take more XENICAL than you should
Danish: Hvis du har taget for meget Xenical
English: • If you have any further questions, please ask your doctor or your pharmacist.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: Bleeding from the back passage (rectum).
Danish: Blødning fra endetarmen.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 °C Opbevar pakningen tæt lukket for at beskytte den mod fugt
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret Xenical til dig personligt.
English: Gastrointestinal disorders
Danish: Risikoen for gastrointestinale bivirkninger (se pkt.
English: Please contact your doctor if you think that the frequency and/or severity of the convulsions have changed when taking Xenical together with antiepileptic drugs.
Danish: Hvis du tager Xenical sammen med medicin mod epilepsi, skal du kontakt din læge, hvis du synes, at du hyppigere får kramper, eller de er blevet alvorligere.
English: • If you get any of the side effects, talk to your doctor or pharmacist.
Danish: • Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,
English: In the absence of pharmacokinetic interaction studies, the concomitant administration of orlistat with acarbose should be avoided.
Danish: Acarbose Det frarådes at bruge orlistat sammen med acarbose på grund af manglende interaktionsstudier.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER OG BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: The possibility of this happening may increase if Xenical is taken with a diet high in fat.
Danish: Dette sker kun, hvis fedtindholdet i kosten er højt.
English: 8 August 2012
Danish: Den 8. august 2012
English: What is Flolan?
Danish: Hvad er Flolan?
English: Flolan is authorised in the EU via national procedures.
Danish: Flolan blev godkendt i EU via nationale procedurer.
English: The European Commission issued a decision on 8 August 2012.
Danish: Europa-Kommissionen traf en afgørelse den 8. august 2012.
English: Flolan is marketed in the following EU Member States: Austria, Belgium, Czech Republic, Denmark, Estonia, France, Ireland, Italy, Luxembourg, Malta, the Netherlands, Spain, United Kingdom, as well as Norway.
Danish: Flolan er godkendt i følgende EU-medlemsstater: Belgien, Danmark, Estland, Det Forenede Kongerige, Frankrig, Irland, Italien, Luxembourg, Malta, Nederlandene, Spanien, Tjekkiet og Østrig samt i Norge.
English: Why was Flolan reviewed?
Danish: Hvorfor blev Flolan vurderet igen?
English: On 24 May 2012, the European Medicines Agency completed a review of Flolan.
Danish: Den 24. maj 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Flolan.
English: Flolan is a medicine that contains the active substance epoprostenol.
Danish: Flolan er et lægemiddel, der indeholder det aktive stof epoprostenol.
English: It is also available under the trade name Epoprostenol.
Danish: Det leveres også under handelsnavnet epoprostenol.
English: The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation), 4.5 (Interaction with Other Medicinal Products and Other Forms of Interaction) and 4.8 (side effects).
Danish: CHMP harmoniserede desuden andre afsnit af produktresuméet, herunder afsnit 4.6 (graviditet og amning), 4.5 (interaktion med andre lægemidler og andre former for interaktion) og 4.8 (bivirkninger).
English: On 15 June 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Flolan in the EU.
Danish: Den 15. juni 2011 indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Flolan i EU.
English: • haemodialysis in emergency situations when the use of heparin carries a high risk of causing or exacerbating bleeding, or when heparin is otherwise contraindicated.
Danish: • anvendelse ved hæmodialyse i akutte situationer, hvor heparin medfører højere risiko for blød ning eller forværring af blødning, eller hvor heparin af anden grund ikke bør anvendes.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Flolan in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktoplysningerne for Flolan i Den Europæiske Union (EU).
English: After reviewing the available data supporting the use of the medicine, the CHMP agreed that Flolan should be used for the following:
Danish: Efter gennemgang af de oplysninger, der dokumenterer lægemidlets anvendelse, fandt CHMP, at Flolan bør anvendes til følgende:
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Flolan in the elderly and patients with reduced kidney and liver function.
Danish: Foruden indikationerne harmoniserede CHMP også anbefalingerne for brug af Flolan hos ældre og hos patienter med nedsat nyre- eller leverfunktion.
English: Epoprostenol also widens the blood vessels which helps to lower the blood pressure in the lungs.
Danish: Epoprostenol udvider desuden blodkarrene, hvilket mindsker blodtrykket i lungerne.
English: The CHMP was of the view that patients with pulmonary veno-occlusive disease could benefit from treatment with Flolan and that for hypotension and angina it was more appropriate to include relevant warnings in section 4.4.
Danish: CHMP fandt, at patienter med pulmonal venookklusiv sygdomme kan have fordel af behandling med Flolan, og at advarslerne vedrørende hypotension og angina bør anbringes i punkt 4.4.
English: It is used to prevent blood clotting during haemodialysis (technique for removing waste products from the blood used in patients with kidney disease).
Danish: Det anvendes til at forhindre størkning af blodet under hæmodialyse (en teknik, der anvendes til at fjerne affaldsstoffer i blodet hos patienter med nyresygdom).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de forelagte data og den videnskabelige drøftelse i udvalget fandt CHMP, at produktresuméer, etikettering og indlægssedler bør harmoniseres i EU.
English: Flolan is also used to treat a lung condition called ‘pulmonary arterial hypertension' (high blood pressure in the lungs).
Danish: Flolan anvendes desuden til behandling af lungesygdommen "pulmonal arteriel hypertension" (forhøjet blodtryk i lungerne).
English: In harmonising the contraindications, the CHMP decided to remove three contraindications that were in the SmPCs of some EU countries: pulmonary veno-occlusive disease, hypotension and angina.
Danish: Ved harmoniseringen af kontraindikationerne besluttede CHMP at udelade tre kontraindikationer, der var anført i produktresuméerne i visse EU-lande: pulmonal venookklusiv sygdom (tilstopning af venerne fra lungerne), hypotension (for lavt blodtryk) og angina (hjertekrampe).
English: • treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH
Danish: • forbedring af den fysiske kapacitet ved pulmonal arteriel hypertension (PAH) (idiopatisk eller arvelig PAH og PAH ved bindevævssygdomme) hos patienter med symptomer af WHO funkti onsklasse III-IV
English: Flolan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMD(h)) fandt, at der er behov for harmonisering for Flolan.
English: The active substance in Flolan, epoprostenol, is a natural occurring prostaglandin that works by stopping the blood from clotting.
Danish: Det aktive stof i Flolan, epoprostenol, er et naturligt prostaglandin, der virker ved at forhindre blodets størkning: Det standser aktiveringen af blodets størkningsmekanisme ved at forhindre blodpladerne i at klumpe sammen (blodpladerne er de elementer i blodet, der muliggør blodets størkning).
English: This might be every 6 to 12 months.
Danish: Dette kan være hver 6. til 12. måned.
English: Date of first authorisation: 17 November 1997 Date of latest renewal: 17 September 2007
Danish: Dato for første markedsføringstilladelse: 17. november 1997 Dato for seneste fornyelse: 17. september 2007
English: Your dose will be specific to you.
Danish: Din dosis vil være specifik for dig.
English: From a microbiological safety point of view, the product should be used immediately.
Danish: Af hensyn til den mikrobiologiske sikkerhed skal produktet anvendes med det samme.
English: No interaction studies have been performed.
Danish: Der er ikke udført nogen interaktionsundersøgelser.
English: Therefore no special dosage regimen can be recommended.
Danish: Derfor kan der ikke anbefales noget særligt doseringsregimen.
English: The current medical standards for emergency treatment are to be observed.
Danish: De nuværende medicinske standarder for nødbehandling bør observeres.
English: Your patient data will be registered anonymously- nobody will know it is information about you.
Danish: Dine patientdata vil blive registreret anonymt - ingen vil vide, at det er oplysninger om dig.
English: The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Danish: Oplysningerne i denne indlægsseddel gælder for alle patientgrupper, inklusive børn, unge, voksne og de ældre.
English: Your doctor will work out your dose based on how severe your symptoms are, and other factors.
Danish: Din læge vil udarbejde din dosis baseret på, hvor alvorlige dine symptomer er og andre faktorer.
English: Please contact your doctor if you would like to be treated at home.
Danish: Kontakt lægen, hvis du ønsker at blive behandlet hjemme.
English: Your doctor may advise that you can be treated at home provided you meet certain criteria.
Danish: Lægen kan anbefale, at du behandles hjemme, forudsat at du opfylder visse kriterier.
English: The non-neurological manifestations of Gaucher disease include one or more of the following conditions:
Danish: Ikke-neurologiske manifestationer af Gauchers sygdom omfatter én eller flere af følgende tilstande:
English: Your doctor will keep a close check on your response to your treatment, and may change your dose (up or down) until he/she finds the best dose to control your symptoms.
Danish: Din læge vil føre nøje kontrol med dit respons på din behandling og kan ændre din dosis (op eller ned), indtil han/hun finder den bedste dosis til at behandle dine symptomer.
English: The ICGG Gaucher Registry
Danish: ICGG Gaucher-registret
English: Once this dose is found your doctor will still keep a check on your responses to make sure you are using the right dose.
Danish: Når denne dosis først er fundet, vil din læge stadigvæk holde øje med dit respons for at sikre sig, at du får den rette dosis.
English: It can occur whether the patient is treated with Cerezyme or not.
Danish: Det kan forekomme, hvadenten patienten behandles med Cerezyme eller ej.
English: Onset of such symptoms has occurred during or shortly after infusions.
Danish: Sådanne symptomer er opstået under eller kort efter infusion.
English: Some side effects were seen primarily while patients were being given the medicine or shortly after.
Danish: Nogle bivirkninger blev set, mens patienter fik givet medicinen eller kort tid herefter.
English: This will not lead to any loss of imiglucerase activity.
Danish: Dette vil ikke medføre tab af imigluceraseaktivitet.
English: These symptoms generally respond to treatment with antihistamines and/or corticosteroids.
Danish: Disse symptomer responderer generelt på behandling med antihistaminer og/eller kortikosteroider.