FrancophonIA/ELRC3.0 huggingface dataset:
English: A 1 mg unit dose blister gives about the same dose as an injection of 3 IU of fast-acting subcutaneous insulin and a 3 mg unit dose blister about the same as 8 IU of fast-acting subcutaneous insulin.
Danish: En 3 mg enkeltdosisblister giver omtrent samme dosis som 8 IE hurtigtvirkende insulin indgivet subkutant.
English: Once in the blood, the insulin facilitates the transport of glucose into cells and helps to control the level of blood sugar.
Danish: Når insulinet er gået over i blodet, er det med til at transportere sukkeret ind i cellerne og regulere
English: What benefit has Exubera shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Exubera?
English: The insulin is contained as a powder in a blister.
Danish: Insulinpulveret er emballeret i blister (trykpakning).
English: In conclusion, the questions have been addressed satisfactorily by the applicant.
Danish: Det kan konkluderes, at ansøgeren har besvaret spørgsmålene tilfredsstillende.
English: The CHMP has recommended the granting of the Marketing Authorisation(s).
Danish: CHMP anbefalede udstedelse af markedsføringstilladelse(r).
English: 78-110%) were outside the conventional limits they comply with the wider 75-133% criterion.
Danish: 78-110 %) lå uden for de sædvanlige acceptable grænser, opfylder de det bredere 75-133 % kriterium.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOLE AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LANSOPRAZOL OG TILKNYTTEDE NAVNE (se bilag I)
English: Member State Marketing Authorisation Holder Applicant
Danish: Indehaver af markedsføringstilladelse
English: Documentation presented to the CHMP shows that the test and reference products are essentially similar.
Danish: Den dokumentation, der blev forelagt for CHMP, viser, at test- og referenceprodukterne i det væsentlige svarer til hinanden.
English: On 30 November 2006, the application has been referred and submitted for arbitration according to Article 29 of Directive 2001/83/EC, as amended.
Danish: Den 30. november 2006 blev ansøgningen indbragt for voldgift i henhold til artikel 29 i direktiv 2001/83/EF, med senere ændringer.
English: The Applicant has provided sufficient data to support that the outcome of the fed study does not lead to a potential risk to public health.
Danish: Ansøgeren har forelagt tilstrækkelige oplysninger til at underbygge, at resultatet af den postprandiale undersøgelse ikke indebærer potentiel sundhedsrisiko.
English: In September 2006, a Mutual Recognition Procedure was started for Lansoprazole involving 16 CMS with the UK as Reference Member State (RMS).
Danish: I september 2006 indledtes en gensidig anerkendelsesprocedure for lansoprazol med inddragelse af 16 berørte medlemsstater og med Det Forenede Kongerige som referencemedlemsstat.
English: This is supported by two similar fed studies using the same reference drug and the same test drug with the same batch number when entirely different results are obtained and which confidence intervals were within conventionally acceptable limits.
Danish: Dette støttes af to tilsvarende postprandiale undersøgelser med samme referencelægemiddel og samme teststof med samme batchnummer, hvor der er opnået helt anderledes resultater, og hvor sikkerhedsintervallerne var inden for de sædvanlige acceptable grænser.
English: Lansoprazole has a wide therapeutic window regarding its clinical efficacy and safety.
Danish: Lansoprazol har et bredt terapeutisk vindue med hensyn til klinisk virkning og sikkerhed.
English: Swensweg 5, Postbus 552, 2003 RN Haarlem
Danish: Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
English: It was considered that this wider criterion can be applied in this case because of the extremely high intra-subject variability (70- 82%) under fed conditions shown in this study.
Danish: Dette bredere kriterium fandtes i dette tilfælde at kunne anvendes på grund af den ekstremt høje intra-individuelle variation (70-82 %), der blev påvist postprandialt i undersøgelsen.
English: Both products show pronounced food effect although the generic product appears to be more affected largely because of the high intra-subject variability.
Danish: For begge produkter er der udtalt effekt af fødeindtagelse, idet effekten dog synes at være størst for det generiske produkt, hovedsagelig som følge af den store intraindividuelle variation.
English: This is a known pharmacokinetic characteristic of Lansoprazole, particularly when taken with high fat and calorie meal as in the current case.
Danish: Dette er en kendt farmakokinetisk egenskab ved Lansoprazol, navnlig når det tages sammen med et meget fedtholdigt, kalorierigt måltid som i det aktuelle tilfælde.
English: The results of these fed studies demonstrate that Lansoprazole's bioavailability is not only markedly reduced when taken with food, but that its absorption, in the presence of food, can be very erratic.
Danish: Resultaterne af disse postprandiale undersøgelser viser, at lansoprazols biotilgængelighed ikke kun nedsættes markant ved fødeindtagelse, men at absorptionen i forbindelse med fødeindtagelse kan være meget uregelmæssig.
English: 1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12
Danish: 1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 France
English: The results were also considered acceptable on clinical grounds as lansoprazole's efficacy is largely independent of dose at this therapeutic dose range.
Danish: Resultaterne blev endvidere anset for acceptable af kliniske grunde, da lansoprazols virkning stort set er dosisuafhængig i dette terapeutiske dosisinterval.
English: It also has a flat dose/response curve i.e. its efficacy is largely independent of the dose.
Danish: Det har også en flad dosis-responskurve, dvs. virkningen er i vid udstrækning dosisuafhængig.
English: This means that the small difference in blood levels between the reference and test products shown under fed conditions is of no clinical significance.
Danish: Det betyder, at den lille forskel i serumkoncentration mellem reference- og testprodukt, der blev fundet postprandialt, er uden klinisk betydning.
English: The RMS approved the product on the basis of the results of the fasted study showed unequivocal equivalence as shown by the 90% confidence intervals (CI) for the AUC and Cmax which were within the conventional 80-125% bioequivalence range.
Danish: Referencemedlemsstaten godkendte produktet på grundlag af resultaterne af undersøgelsen i fastende tilstand, hvor bioækvivalens klart blev påvist, idet 90 % sikkerhedsintervallerne for AUC og Cmax lå inden for det acceptable bioækvivalensinterval på 80-125 %.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: United Kingdom TEVA UK Limited Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Danish: Storbritannien TEVA UK Limited Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
English: Lansoprazole is a proton pump inhibitor that inhibits gastric acid secretion and is used for the treatment of duodenal and benign gastric ulcers, gastrooesophageal reflux disease and associated conditions.
Danish: Lansoprazol er en syrepumpehæmmer, der hæmmer syresekretionen i ventriklen og anvendes til behandling af ulcus duodeni og benignt ulcus ventriculi, gastro-øsofageal reflukssygdom og tilknyttede lidelser.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure as mentioned in Annex III.
Danish: De gældende tekster til produktresumé, etikettering og indlægsseddel er de endelige versioner, der blev fastlagt ved behandlingen i koordinationsgruppen som nævnt i bilag III.
English: TEVA Magyarország Rt Rákóczi út 70-72, Budapest, H
Danish: TEVA Magyarország Rt Rákóczi út 70-72, Budapest, H-1074, Hungary
English: Lansoprazole 15 & 30 mg gastro-resistant capsules, hard (Teva UK Ltd) are generic preparations containing lansoprazole as the active substance.
Danish: Lansoprazol, enterokapsler, hårde, 15 og 30 mg (Teva UK Ltd) er generiske præparater, der indeholder lansoprazol som det aktive stof.
English: Industrieweg 23, P.O.
Danish: Industrieweg 23, P.O. Box 217,
English: Although the CI for the fed study results (CI for AUCinf.
Danish: Skønt sikkerhedsintervallet i den postprandiale undersøgelse (SI for AUCinf.
English: The objecting Concerned Member States raised public health objections on the grounds that while bioequivalence was proven in the fasting state, the same was not the case under fed conditions.
Danish: Den medlemsstat, der gjorde indsigelse, fandt, at udstedelse af en markedsføringstilladelse kunne udgøre en sundhedsfare, fordi bioækvivalens kun var påvist fastende, ikke postprandialt.
English: Box 217, 3640 AE Mijdrecht The Netherlands
Danish: Industrieweg 23, P.O. Box 217, 3640 AE Mijdrecht The Netherlands
English: Box 217, 3640 AE Mijdrecht, The Netherlands,
Danish: Teva Pharma B.V., Industrieweg 23, P.O. Box 217, 3640 AE Mijdrecht, The Netherlands,
English: Date of first authorisation: 16 November 2004 Date of latest renewal: 18 July 2014
Danish: Dato for første markedsføringstilladelse: 16. november 2004 Dato for seneste fornyelse: 18. juli 2014
English: They are marked with ‘S 063'.
Danish: De er mærket med ‘S 063'.
English: Do not take more capsules than your doctor has recommended.
Danish: Tag ikke flere kapsler, end Deres læge har anbefalet.
English: Your doctor will prescribe the best dose for you.
Danish: Deres læge vil ordinere den bedste dosis til Dem.
English: You can take the capsules with food or after a meal or on an empty stomach.
Danish: De kan tage kapslerne med mad, efter et måltid eller på tom mave.
English: • If you have or think you might have a problem with your heart;
Danish: • Hvis De har eller mener, at De måske har et problem med hjertet;
English: 9/l or a ≥ 50% reduction from baseline and maintenance of the reduction for at least 4 weeks.
Danish: 9/l eller en ≥ 50% reduktion i forhold til baseline og opretholdelse af reduktionen i mindst 4 uger.
English: Xagrid (on the outer carton only)
Danish: Xagrid (kun på den ydre karton)
English: 9/l or
Danish: 9/l eller
English: Lactose is an ingredient in this medicine.
Danish: Lactose er et indholdsstof i dette lægemiddel.
English: • a platelet count > 1000 x 10
Danish: • et blodpladetal på > 1000 x 10
English: Xagrid is supplied as opaque, white, hard capsules.
Danish: Xagrid leveres som uigennemsigtige, hvide, hårde kapsler.
English: Speak to your doctor if you need advice with contraception.
Danish: Tal med Deres læge, hvis De har brug for råd vedrørende antikonception.
English: The amount of Xagrid that people take can be different, and this depends on your condition.
Danish: Det er forskelligt, hvilken mængde Xagrid forskellige mennesker kan indtage, og dette afhænger af Deres tilstand.
English: However, as expected, patients in this age group had twice the incidence of serious adverse events (mainly cardiac).
Danish: Patienter i denne aldersgruppe havde imidlertid som forventet dobbelt så mange tilfælde af alvorlige negative begivenheder (hovedsagelig vedrørende hjertet).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list)) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Xagrid or these medicines may not work properly if taken together.
Danish: Xagrid eller disse lægemidler virker måske ikke korrekt, hvis de tages samtidigt.
English: Within the system organ classes they are listed under the following headings: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Inden for de enkelte systemorganklasserne: Meget almindelig (≥1/10); Almindelig (≥1/100 til <1/10); Ikke almindelig (≥1/1.000 til <1/100); Sjælden (≥1/10.000 til <1/1.000); Meget sjælden (<1/10.000); Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Tell your doctor if you are pregnant or are planning to become pregnant.
Danish: Fortæl Deres læge det, hvis De er gravid eller planlægger at blive gravid.
English: After this time, your doctor may either increase or decrease the number of capsules that you take to find the dose best suited to you and which treats your condition most effectively.
Danish: Derefter kan Deres læge enten øge eller reducere antallet af kapsler, De skal tage, for at finde den dosis, der bedst passer Dem, og som behandler Deres tilstand mest effektivt.
English: An opaque white hard capsule imprinted with S 063.
Danish: En uigennemsigtig hvid, hård kapsel med påtrykt S 063.
English: Food also decreased the Cmax of the active metabolite, 3-hydroxyanagrelide, by 29%, although it had no effect on the AUC.
Danish: Mad reducerede også Cmax for den aktive metabolit, 3-hydroxyanagrelid, med 29 %, selvom det ikke havde nogen virkning på AUC.
English: After one week the dose may be titrated, on an individual basis, to achieve the lowest effective dose required to reduce and/or maintain a platelet count below 600 x 10
Danish: Efter en uge kan dosis titreres på individuel basis, så man opnår den laveste, effektive dosis, der er nødvendig for at reducere og/eller opretholde et blodpladetal på under 600 x 10
English: Take your capsules as soon as you remember.
Danish: Tag kapslerne, så snart De kommer i tanker om det.
English: Your doctor will ask you to have blood tests at regular intervals to check that your medicine is working effectively and that your liver and kidneys are working well.
Danish: Deres læge vil bede Dem få taget blodprøver med jævne mellemrum for at kontrollere, at medicinen virker effektivt, og at Deres lever og nyrer fungerer, som de skal.
English: Less than 1% is recovered in the urine as anagrelide.
Danish: Under 1 % genfindes i urinen som anagrelid.
English: The plasma half-life of anagrelide is short, approximately 1.3 hours and as expected from its half-life, there is no evidence for anagrelide accumulation in the plasma.
Danish: Halveringstiden i plasma af anagrelid er kort, ca. 1,3 timer, og som det forventes fra halveringtiden, er der ikke evidens for akkumulation af anagrelid i plasma.
English: Your capsules should be swallowed whole with a glass of water.
Danish: De skal sluge kapslerne hele med et glas vand.
English: The mean recovery of 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline in urine is approximately 18-35% of the administered dose.
Danish: Den gennemsnitlige genfinding af 2-amino-5, 6-dichloro-3, 4-dihydroquinazolin i urinen er ca. 18-35 % af den administrerede dosis.
English: Rare: Kidney failure (when you pass little or no urine), heart attack.
Danish: Sjælden: Nyresvigt (De udskiller kun lidt eller ingen urin), hjerteanfald.
English: Do not remove or eat the drying agent.
Danish: Undlad at fjerne eller spise tørremidlet.
English: The capsules are provided in bottles containing 100 hard capsules.
Danish: Kapslerne leveres i glas med 100 hårde kapsler.
English: Show them the pack of Xagrid.
Danish: Vis dem Xagrid emballagen.
English: High-density polyethylene (HDPE) bottles with child-resistant closures and desiccant containing 100 capsules.
Danish: Flaske af high-density polyethylen (HDPE) med børnesikret lukning, der indeholder tørremiddel, og 100 kapsler.
English: Like all medicines, Xagrid can cause side effects, although not everybody gets them.
Danish: Xagrid kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: It reduces the number of platelets produced by the bone marrow, which results in a decrease in the platelet count in the blood towards a more normal level.
Danish: Det reducerer det antal blodplader, som knoglemarven producerer, hvilket medfører et fald i antallet af blodplader i blodet hen imod et mere normalt niveau.
English: See the instructions in the patient leaflet of the contraceptive pill you are taking.
Danish: Se anvisninger i indlægssedlen for den svangerskabsforebyggende tablet, som De tager.
English: Do not drive or use machines if you feel dizzy.
Danish: Kør ikke bil og betjen ikke maskiner, hvis De føler Dem svimmel.
English: Pharmacotherapeutic group: Other antineoplastic agents, ATC Code: L01XX35.
Danish: Farmakoterapeutisk klassifikation: Andre antineoplastiske stoffer, ATC-kode: L01XX35.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og flaskens etiket efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Talk to your doctor before taking Xagrid:
Danish: Kontakt lægen, før De tager Xagrid:
English: Treatment with Xagrid should be initiated by a clinician with experience in the management of essential thrombocythaemia.
Danish: Behandling med Xagrid kapsler skal startes af en kliniker med erfaringer i styring af essentiel trombocytæmi.
English: Always take Xagrid exactly as your doctor has told you.
Danish: Tag altid Xagrid nøjagtigt efter lægens anvisning.
English: Method of Administration For oral use.
Danish: Administration Til oral anvendelse.
English: Women who are at risk of becoming pregnant should make sure that they are using effective contraception when taking Xagrid.
Danish: Kvinder, der kan blive gravide, skal sikre, at de anvender effektiv antikonception, medens de tager Xagrid.
English: The most commonly reported adverse reactions associated with anagrelide were headache occurring at approximately 14%, palpitations occurring at approximately 9%, fluid retention and nausea both occurring at approximately 6% and diarrhoea occurring at 5%.
Danish: De hyppigst indberettede bivirkninger forbundet med anagrelid var hovedpine, der optrådte hos ca. 14%, palpitationer hos ca. 9%, væskeophobning og kvalme forekom begge hos ca. 6%, og diare forekom hos 5%.
English: Pharmacokinetic data from healthy subjects established that food decreases the Cmax of anagrelide by 14%, but increases the AUC by 20%.
Danish: Farmakokinetiske data fra raske personer klarlagde, at mad nedsætter Cmax for anagrelid med 14 %, men øger AUC med 20 %.
English: Tell your doctor if you are taking any of the following medicines:
Danish: Fortæl Deres læge om De tager en eller flere slags anden medicin:
English: In clinical development, dizziness was commonly reported.
Danish: Under den kliniske udvikling blev svimmelhed ofte indberettet.
English: • Anagrelide may cause intestinal disturbance in some patients and compromise the absorption of hormonal oral contraceptives.
Danish: • Anagrelid kan medføre intestinal forstyrrelse hos nogle patienter og skade absorberingen af hormonal, oral antikonception.
English: If you are worried, speak to your doctor.
Danish: Hvis De er bekymret herfor, skal De kontakte Deres læge.
English: If your doctor stops your medicine, do not keep any leftover capsules unless your doctor tells you to. Do not throw away any medicines via wastewater or household waste.
Danish: Hvis Deres læge standser Deres medicinering, må De ikke beholde eventuelle resterende kapsler, med mindre Deres læge beder Dem om det. Spørg på apoteket, hvordan De skal bortskaffe medicinrester.
English: If you take more Xagrid than you should or if someone else has taken your medicine, tell a doctor or pharmacist immediately.
Danish: Hvis De har taget for meget Xagrid, eller hvis en anden har taget Deres medicin, skal De straks underrette Deres læge eller apotek.
English: Your doctor may do a blood test which may show an increase in your liver enzymes.
Danish: Deres læge vil muligvis tage en blodprøve, som eventuelt kan vise forhøjede leverenzymer.
English: The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four openlabel, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4000 patients with myeloproliferative neoplasms (MPNs).
Danish: Anagrelids sikkerhed og virkning som et middel til reduktion af blodpladerne er vurderet i fire openlabel, ikke-kontrollerede kliniske undersøgelser (undersøgelsesnummer 700-012, 700-014, 700-999 og 13970-301), der omfattede mere end 4000 patienter med myeloproliferative neoplasmer (MPN).
English: Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III and because of its positive inotropic and chronotropic effects, anagrelide should be used with caution in patients of any age with known or suspected heart disease.
Danish: Anagrelid hæmmer cyklisk AMP-fosfodiesterase III, og på grund af dets positive inotope og kronotrope virkninger skal anagrelid anvendes med forsigtighed hos patienter med kendt eller mistænkt hjertesygdom uanset alder.
English: In patients with essential thrombocythaemia complete response was defined as a decrease in platelet count to ≤ 600 x
Danish: Hos patienter med essentiel trombocytæmi blev komplet respons defineret som et fald i blodpladetallet til ≤ 600 x10
English: Name and address of the manufacturer(s) responsible for batch release Shire Pharmaceuticals Ireland Limited, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower Dublin 2, Ireland
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse Shire Pharmaceuticals Ireland, Block 2 & 3 Miesian Plaza, 50 - 58 Baggot Street Lower Dublin 2, Irland
English: Mutagenic and carcinogenic potential Studies on the genotoxic potential of anagrelide did not identify any mutagenic or clastogenic effects.
Danish: Undersøgelser vedrørende anagrelids genotoksiske potentiale har ikke identificeret nogen mutagene eller klastogene virkninger.
English: Linearity Dose proportionality has been found in the dose range 0.5 mg to 2 mg.
Danish: Linearitet Der er fundet dosisproportionalitet i dosisintervallet fra 0,5 mg til 2 mg.
English: Shire Pharmaceuticals Ireland Limited Dublin 2
Danish: Shire Pharmaceuticals Ireland Ltd. Dublin 2
English: You must stop breast-feeding if you are taking Xagrid.
Danish: De skal holde op med at amme, hvis De tager Xagrid.
English: Xagrid contains the active substance, anagrelide.
Danish: Xagrid indeholder det aktive stof, anagrelid.
English: Diagnostic guidelines for essential thrombocythemia should be followed carefully and diagnosis reassessed periodically in cases of uncertainty, with effort made to distinguish from hereditary or secondary thrombocytosis, which may include genetic analysis and bone marrow biopsy.
Danish: Diagnostiske retningslinjer for essentiel trombocytæmi bør følges nøje, og ved usikkerhed bør diagnosen revurderes regelmæssigt med bestræbelser på at differentiere mellem hereditær og sekundær trombocytose, hvilket kan omfatte genetisk analyse og knoglemarvsbiopsi.
English: • Other medicines used to treat conditions affecting the platelets in your blood, e.g. clopidogrel;
Danish: • Anden medicin til behandling af tilstande, der påvirker blodpladerne i Deres blod, f.eks. clopidogrel;
English: Anagrelide is primarily metabolised by CYP1A2 to form, 3-hydroxy anagrelide, which is further metabolised via CYP1A2 to the inactive metabolite, 2-amino-5, 6-dichloro-3, 4-dihydroquinazoline.
Danish: Anagrelid metaboliseres primært ved CYP1A2; så der dannes 3-hydroxyanagrelid, som metaboliseres videre via CYP1A2 til den inaktive metabolit, 2-amino-5, 6-dichloro-3, 4-dihydroquinazolin.
English: Keep the sealed container in the bottle.
Danish: Lad den forseglede beholder blive i glasset.