FrancophonIA/ELRC3.0 huggingface dataset:
English: What [Invented name] looks like and contents of the pack [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Danish: [særnavn] udseende og pakningsstørrelser [Afsnittet skal tilpasses med beskrivelse af længden på den blottede del af nålen på det relevante medicinske udstyr] [Skal udfyldes nationalt]
English: Section 3 - How to use [Invented name] [The section should be amended to reflect the following wording]
Danish: Afsnit 3 - Sådan skal du bruge [særnavn] [Afsnittet skal tilpasses følgende ordlyd]
English: All patients who are prescribed [Invented name] should be thoroughly instructed to understand the indications for the use and the correct method of administration (see section 6.6).
Danish: Alle patienter, som får udskrevet [særnavn], skal have grundig vejledning i indikationerne for brug, og hvordan de indgiver [særnavn] korrekt (se pkt.
English: Section 4.2 - Posology and method of administration [The section should be amended to reflect the following wording]
Danish: Afsnit 4.2 - Dosering og indgivelsesmåde [Afsnittet skal tilpasses følgende ordlyd]
English: Section 6.5 - Nature and contents of container [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Danish: Afsnit 6.5 - Emballagetyper og pakningsstørrelser [Afsnittet skal tilpasses med beskrivelse af længden på den blottede del af nålen på det relevante medicinske udstyr]
English: [The MAH(s) should submit improved diagram in the instructions for use by increasing the size and ensuring that it clearly shows that the injection should be in the antero-lateral aspect of the thigh]
Danish: Det skal være større, og det skal gøres tydeligere, at injektionen skal ske antero-lateralt på låret]
English: The course of treatment may be repeated but not sooner than 21 days after the start of the first course.
Danish: Behandlingsforløbet kan gentages, men ikke før 21 dage efter påbegyndelsen af første behandlingsforløb.
English: The company that markets these medicines is Bristol-Myers Squibb.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Bristol-Myers Squibb.
English: Etopophos is marketed in the following EU member States: France, Germany, Sweden and the United Kingdom.
Danish: Etopophos markedsføres i følgende EU-medlemsstater: Frankrig, Tyskland, Sverige og Det Forenede Kongerige.
English: What is Etopophos?
Danish: Hvad er Etopophos?
English: The recommended dose for adults is 50 to 100 mg per m2 of body surface area for 5 days in a row or 100 to 120 mg/m2 on days 1, 3 and 5.
Danish: Den anbefalede dosis til voksne er 50100 mg/m2 legemsoverflade i 5 på hinanden følgende dage, eller 100-120 mg/m2 på dag 1, 3 og 5.
English: Etopophos is authorised in the EU via national procedures.
Danish: Etopophos er godkendt i EU via nationale procedurer.
English: On 21 April 2017, the European Medicines Agency completed a review of Etopophos.
Danish: Den 21. april 2017 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Etopophos.
English: Why was Etopophos reviewed?
Danish: Hvorfor blev Etopophos vurderet igen?
English: • testicular cancer, including cancer that is resistant to treatment or has come back;
Danish: • testikelkræft, herunder testikelkræft, som behandling ikke har virket på, eller som er vendt tilbage
English: The CHMP recommended that Etopophos should be used in combination with other cancer treatments to treat the following cancers:
Danish: CHMP anbefalede, at Etopophos anvendes sammen med andre kræftmidler til behandling af følgende kræftformer:
English: On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Etopophos in the EU.
Danish: Den 14. oktober 2015 indbragte Europa-Kommissionen sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Etopophos i EU.
English: • acute myeloid leukaemia;
Danish: • akut myeloid leukæmi
English: • high-risk gestational trophoblastic neoplasia as first- and second-line treatments;
Danish: • højrisiko-trofoblastsvulster, som første- og andetvalgsbehandling
English: It is also available in the EU under the trade name Etopofos.
Danish: Det fås desuden i EU under handelsnavnet Etopofos.
English: For blood cancers (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia), Etopophos is recommended for both adults and children, while its other uses are for adults only.
Danish: Ved blodkræft (Hodgkins og ikke-Hodgkins lymfom og akut myeloid leukæmi) anbefales Etopophos til både voksne og børn, mens dets andre anvendelser kun er til voksne.
English: Etopophos is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer, gestational trophoblastic neoplasia (a rare tumour of the womb that occurs during pregnancy) and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Danish: Etopophos er et kræftlægemiddel til behandling af: testikelkræft, lungekræft, ovariecancer, gestationel trofoblastsvulst (en sjælden livmodersvulst, der opstår under svangerskab) og blodkræft (Hodgkins og ikke-Hodgkins lymfom og akut myeloid leukæmi).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Etopophos and associated names in the European Union (EU).
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Etopophos og relaterede navne i EU.
English: • non-epithelial ovarian cancer.
Danish: • ikke-epitelial ovariecancer.
English: Etopophos is given as a slow intravenous infusion.
Danish: Etopophos gives langsomt med drop (ved intravenøs infusion).
English: In addition, the CHMP recommended Etopophos for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.
Danish: CHMP anbefalede derudover Etopophos til behandling af epitelial ovariecancer, som platinholdige lægemidler ikke virker på, uden angivelse af, om det skal anvendes i kombination med andre lægemidler.
English: • Hodgkin's and non-Hodgkin's lymphoma;
Danish: • Hodgkins og ikke-Hodgkins lymfom
English: Etopophos should not be administered during vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be given to breast-feeding women.
Danish: Hos patienter med svækket immunsystem bør Etopophos ikke gives sammen med vaccination mod gul feber eller andre levende vacciner, og det bør ikke gives til ammende kvinder.
English: Etopophos contains the active substance etoposide (as etoposide phosphate) and is available as a powder to be made into a solution for infusion into a vein.
Danish: Etopophos indeholder det aktive stof etoposid (som etoposidfosfat) og fås som et pulver til fremstilling af en opløsning, der indgives med drop i en vene (ved infusion).
English: Etopophos was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: CMD(h) (Koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurerlægemidler til mennesker) fandt det nødvendigt at harmonisere for Etopophos.
English: Denmark Teva Denmark A/S, Parallelvej 10,
Danish: Danmark Teva Denmark A/S, Parallelvej 10,
English: 2800 Kongens Lyngby Denmark
Danish: 2800 Kongens Lyngby Danmark
English: 1123 Budapest
Danish: 1123 Budapest Ungarn
English: 3641 RT Mijdrecht Nederland
Danish: 3641 RT Mijdrecht Holland
English: Denmark Teva UK Limited Brampton Road
Danish: Danmark Teva UK Limited Brampton Road
English: ANNEX I LIST OF THE PRODUCT NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND ICELAND
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Netherlands Bayer BV Energieweg 1
Danish: Bayer BV Energieweg 1
English: BN22 9AG East Sussex United Kingdom
Danish: BN22 9AG East Sussex Storbritannien
English: Hungary Bayer Hungária Kft Alkotás ut.50
Danish: Bayer Hungária Kft Alkotás ut.50
English: RECORDATI ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Spain
Danish: RECORDATI ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Spanien
English: Via M. Civitali, 1 20148 Milano Italy
Danish: Via M. Civitali, 1 20148 Milano Italien
English: Bayer Hellas Abee Sorou 18-20
Danish: Grækenland Bayer Hellas Abee Sorou 18-20
English: Berkshire RG14 1JA United Kingdom
Danish: Berkshire RG14 1JA
English: BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX France
Danish: Frankrig BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX Frankrig
English: Strawberry Hill Newbury
Danish: Strawberry Hill
English: 15125 Maroussi - Athens Greece
Danish: 15125 Maroussi - Athens Grækenland
English: Viale Certosa, 130 20156 Milano Italy
Danish: Viale Certosa, 130 20156 Milano Italien
English: 151 25 Marousi - Athens Greece
Danish: 151 25 Marousi - Athens Grækenland
English: À Av. da Siderurgia Nacional P.O.
Danish: À Av. da Siderurgia Nacional P.O. Box 56
English: Bayer plc, Pharmaceutical Bayer House
Danish: Storbritannien Bayer plc, Pharmaceutical Bayer House
English: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria
Danish: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Østrig
English: Elpen SA Pharmaceutical Industry 95, Marathonos Avenue 190-09 Pikermi
Danish: Grækenland Elpen SA Pharmaceutical Industry 95, Marathonos Avenue
English: BAYER d.o.o.
Danish: Slovenien BAYER d.o.o.
English: Belgium Therabel Pharma S.A. Rue Egide Van Ophem 108 1180 Bruxelles
Danish: Therabel Pharma S.A. Rue Egide Van Ophem 108 1180 Bruxelles Belgien
English: Belgium Bayer s.a.-n.v. Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgium
Danish: Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgien
English: Moxafloxacin hydrochloride
Danish: Moxafloxacin hydrochlorid
English: Bravničarjeva 13 1000 Ljubljana Slovenia
Danish: 1000 Ljubljana
English: Luxembourg Bayer s.a.-n.v. Avenue Louise 143 Louizalaan 1050 Bruxelles
Danish: Avenue Louise 143 Louizalaan 1050 Bruxelles
English: Germany Bayer Vital GmbH 51368 Leverkusen Germany
Danish: Tyskland Bayer Vital GmbH 51368 Leverkusen Tyskland
English: Bayer Vital GmbH 51368 Leverkusen Germany
Danish: Bayer Vital GmbH 51368 Leverkusen Tyskland
English: Avelox 400 mg - Filmtabletten 400 mg Film-coated tablet
Danish: Avelox 400 mg - Filmtabletten 400 mg Filmovertrukket tablet
English: Avalox 400 mg Filmtabletten 400 mg Film-coated tablet
Danish: Avalox 400 mg Filmtabletten 400 mg Filmovertrukket tablet
English: Bayer Health Care AG 51368 Leverkusen Germany
Danish: Bayer Health Care AG 51368 Leverkusen Tyskland
English: Bayer AG 51368 Leverkusen Germany
Danish: Bayer AG 51368 Leverkusen Tyskland
English: Actira 400 mg film coated tablets400 mg Film-coated tablet
Danish: Actira 400 mg film coated tablets400 mg Filmovertrukket tablet
English: Octegra 400 mg - Filmtabletten 400 mg Film-coated tablet
Danish: Octegra 400 mg - Filmtabletten 400 mg Filmovertrukket tablet
English: Octegra 400 mg Filmtabletten 400 mg Film-coated tablet
Danish: Octegra 400 mg Filmtabletten 400 mg Filmovertrukket tablet
English: Actimax 400 mg Filmtabletten 400 mg Film-coated tablet
Danish: Actimax 400 mg Filmtabletten 400 mg Filmovertrukket tablet
English: Actira 400 mg - Filmtabletten 400 mg Film-coated tablet
Danish: Actira 400 mg - Filmtabletten 400 mg Filmovertrukket tablet
English: Germany Bayer HealthCare AG 51368 Leverkusen
Danish: Tyskland Bayer HealthCare AG 51368 Leverkusen
English: Belgium Bayer AG 51368 Leverkusen Germany
Danish: Bulgarien Bayer AG 51368 Leverkusen Tyskland
English: Denmark Bayer HealthCare AG 51368 Leverkusen
Danish: Danmark Bayer HealthCare AG 51368 Leverkusen
English: Actira 400 mg Filmtabletten 400 mg Film-coated tablet
Danish: Actira 400 mg Filmtabletten 400 mg Filmovertrukket tablet
English: Netherlands Bayer HealthCare AG 51368 Leverkusen
Danish: Rumænien Bayer HealthCare AG 51368 Leverkusen
English: (rounded to the nearest integer value).
Danish: (oprundet til nærmeste hele tal).
English: Absence of a Formulation Difference
Danish: Fravær af en forskel i formuleringerne
English: In conclusion, both results were considered to be fully acceptable.
Danish: Som konklusion anses begge resultaterne for at være fuldt acceptable.
English: Safety results
Danish: Sikkerhedsresultater
English: • The rate of outlying cases from the test formulation must be no greater than the reference + 20 %
Danish: • Antallet af tilfælde fra testformuleringen, som ligger udenfor, må ikke være større end referencen + 20 %
English: The wash-out phase was 7 days.
Danish: Udvaskningsfasen var på 7 dage.
English: The change of name was caused by company takeover.
Danish: Navneændringen skyldtes en virksomhedsovertagelse.
English: The samples were immediately stored at -25°C and transferred to the analytical facility.
Danish: Prøverne blev øjeblikkeligt nedfrosset til -25 °C og sendt til analysefaciliteten.
English: There were no deaths, and no serious or other significant adverse events in the course of the study.
Danish: Der var ingen dødsfald og ingen alvorlige eller andre signifikante bivirkninger i løbet af undersøgelsen.
English: All the available data were included without any imputation or extrapolation.
Danish: Alle de tilgængelige data var medtaget uden imputering eller ekstrapolering.
English: All tests achieved satisfactory results with only small deviations.
Danish: Alle test opnåede tilfredsstillende resultater med kun små afvigelser.
English: For long-term stability a reduction was seen in pantoprazole content of between 6-8% of the nominal content, which was considered acceptable.
Danish: Med hensyn til langsigtet stabilitet sås en reduktion i pantoprazolindholdet på 6-8 % af det nominelle indhold, hvilket blev anset for at være acceptabelt.
English: All tests revealed acceptable results.
Danish: Alle test viste acceptable resultater.
English: For these two pH values similar dissolutions were proven.
Danish: For disse to pH-værdier blev der påvist ensartede opløsninger.
English: All but one of them had either been classified as being clinically not significant or been resolved after the follow-up conducted by the Applicant.
Danish: Alle undtagen en blev klassificeret som værende klinisk insignifikante eller blev løst efter den opfølgning, som ansøgeren gennemførte.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PANTOPRAZOLE BLUEFISH AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF PANTOPRAZOL BLUEFISH OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Population studied
Danish: Undersøgt population
English: No extrapolation or imputation has been used in the statistical analysis.
Danish: Der er ikke anvendt nogen ekstrapolering eller imputering i den statistiske analyse.
English: A period of 15 hours was consequently deemed to be suitable for quantification of at least 80 % of the total AUC, as recommended in the guidelines.
Danish: En periode på 15 timer blev derfor anset for at være passende til kvantificering af mindst 80 % af den samlede AUC som anbefalet i retningslinjerne.
English: The CHMP considered the Applicant's response acceptable.
Danish: CHMP fandt ansøgerens svar acceptabelt.
English: Secondary Analysis
Danish: Sekundær analyse
English: The detailed results of the long-term stability data of human samples were given.
Danish: Der blev fremsendt detaljerede resultater for de langsigtede stabilitetsdata for prøver fra mennesker.
English: During the course of the study, 80 adverse events were reported.
Danish: Under undersøgelsesperioden blev der indberettet 80 bivirkninger.
English: CONDITIONS OF THE MARKETING AUTHORISATION
Danish: BILAG IV BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: The observation period of 30 hours exceeded the minimal requirement for studies with pantoprazole, which is considered to be 24 hours.
Danish: Observationsperioden på 30 timer var længere end minimumskravet for undersøgelser med pantoprazol, der anses for at være på 24 timer.
English: The information on the originator product has been clarified to a satisfactory extent.
Danish: Information om originalpræparatet er blevet fremlagt i tilfredsstillende omfang.
English: • A case will be considered to be an outlier if at least one of the following conditions apply: - There is complete or almost complete lack of absorption of the drug (AUClast is less than 10 % of the mean values of the corresponding formulation) - If T-max is >12 h
Danish: • Et tilfælde vil blive betragtet som en afvigende værdi, hvis mindst en af følgende betingelser er opfyldt: - Der er fuldstændig eller næsten fuldstændig manglende absorption af præparatet (AUClast er under 10 % af gennemsnitsværdierne for den tilsvarende formulering) - Hvis T-max er >12 timer.
English: The Applicant reassured in its answer on the above.
Danish: Ansøgeren fremsendte sit svar om ovenstående.
English: The CHMP found satisfactory justifications regarding the study design in respect to:
Danish: CHMP fandt tilfredsstillende begrundelser for udformningen af undersøgelsen med hensyn til:
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE I MEDLEMSSTATERNE
English: Based on a terminal elimination half-life of approximately 1 hour, three times the half-life was considered sufficient to cover the elimination of 83 % of the drug, and five times the half-life was considered to allow for almost complete elimination.
Danish: Baseret på en terminal eliminationshalveringstid på cirka 1 time blev tre gange halveringstiden anset for at være tilstrækkelig til at dække elimineringen af 83 % af lægemidlet, og fem gange halveringstiden blev anset for at være tilstrækkeligt til en næsten fuldstændig eliminering.
English: SE-111 23 Stockholm Sweden
Danish: SE-111 23 Stockholm Sverige
English: The Applicant showed that the number of patients with an increased % of extrapolated AUC was very low and the variability in both parameters of interest was very high.
Danish: Ansøgeren påviste, at antallet af patienter med en øget % af ekstrapoleret AUC var meget lavt, og variabiliteten i begge de pågældende parametre var meget høj.
English: The Applicant answered that a less strict requirement may apply for pantoprazole and submitted a report on the expected clinical relevance of the delayed absorption of pantoprazole observed in the study 2009-2106.
Danish: Ansøgeren svarede, at et mindre strengt krav kunne gælde for pantoprazol, og fremlagde en rapport om den forventede kliniske relevans af den forsinkede absorption af pantoprazol, der blev observeret i undersøgelse 2009-2106.
English: According with Coupe A.J.
Danish: Ifølge A.J.
English: If a reliable estimate of terminal half-life is necessary this should be obtained by collecting at least three to four samples during the terminal log linear phase.
Danish: Hvis et pålideligt estimat af den terminale halveringstid er nødvendigt, bør dette opnås ved indsamling af mindst 3-4 prøver i den terminale logaritmisk lineære fase.
English: (ii) The results of the analyses of the data from the study and why the applicant considers they exclude a formulation difference under fed conditions.
Danish: (ii) Resultaterne af analyserne af dataene fra undersøgelsen, og hvorfor ansøgeren mener, at de udelukker en formuleringsforskel efter fødeindtagelse.
English: Furthermore a complete analytical certificate (of test and reference product) was provided with all results being compliant with specifications.
Danish: Desuden blev et fuldstændigt analytisk certifikat (af test- og referencepræparatet) fremsendt, og alle resultaterne var i overensstemmelse med specifikationerne.
English: The documentation of the analytical methods comprised an Analytical Report and a Re-validation report.
Danish: Dokumentationen af analysemetoderne omfattede en analyserapport og en revalideringsrapport.
English: Initial Bioequivalence Studies
Danish: Indledende bioækvivalensundersøgelser
English: The expert referred to the results of study 2009-2106 and concluded that there was no dose dumping effect, that a delayed start of the antisecretory effect was observed corresponding to the first dose, and subsequent doses had a minor effect on acid suppression.
Danish: Eksperten henviste til resultaterne af undersøgelsen 2009-2106 og konkluderede, at der ikke var nogen dosisdumpingvirkning, at der observeredes en forsinket indtræden af den sekretionshæmmende virkning svarende til den første dosis, og at efterfølgende doser havde en mindre virkning på syresuppressionen.
English: The CHMP considered this issue resolved.
Danish: CHMP anså dette spørgsmål for at være løst.
English: It included the requested data about long-term stability of human plasma samples along with long-term stability data of stock solutions (749 days at -25°C) and auto-sampler stability (122.5 hours at 5°C).
Danish: Den indeholdt data om den langsigtede stabilitet af plasmaprøver fra mennesker sammen med data om den langsigtede stabilitet af stamopløsninger (749 dage ved -25 °C) og autosamplerstabilitet (122,5 timer ved 5 °C).
English: et al. (1991) food may delay gastric emptying up to 10-11 hours and thus can influence the timing of the absorption of orally administered drugs.
Danish: Coupe et al. (1991) kan fødeindtagelse forsinke ventrikeltømningen med op til 10-11 timer og kan dermed påvirke timingen af absorptionen af lægemidler, der indgives oralt.
English: This, in general, is achieved if the AUC derived from measurements is at least 80 % of the AUC extrapolated to infinity.
Danish: Dette opnås generelt, hvis AUC fra målingerne er mindst 80 % af AUC ekstrapoleret til uendelighed.
English: The manufacturer was Altana for studies Pan 2006/006 and Pan 2006/007, and Nycomed for study 2009-2106.
Danish: Producenten var Altana for undersøgelserne Pan 2006/006 og Pan 2006/007 og Nycomed for undersøgelsen 2009-2106.
English: All of them were of mild severity, some adverse events were eventually related to the study medication.
Danish: De var alle milde, og nogle af bivirkningerne blev senere relateret til undersøgelsesmedicinen.
English: Furthermore, an increase in T-max from 1-4 hours under fasting conditions to between 5 and 12 hours (attributed to delayed absorption with food) was published by the FDA in their Summary of Approval of the originator, Protonix 20 mg and Protonix 40 mg. [US FDA Summary of Approval Protonix 20 mg and Protonix 40 mg].
Danish: Desuden offentliggjorde FDA en stigning i T-max fra 1-4 timer under faste til mellem 5 og 12 timer (tilskrevet forsinket absorption med fødeindtagelse) i sit resumé af godkendelsen af originalpræparatet, Protonix 20 mg og Protonix 40 mg. [US FDA Summary of Approval Protonix 20 mg og Protonix 40 mg].
English: As such, the planned sampling schedule should provide an adequate estimation of the Cmax and should cover the plasma concentration time curve sufficiently to provide a reliable estimate of the extent of absorption.
Danish: Det planlagte prøvetagningsskema bør som sådan give et passende estimat over Cmax og bør dække tidskurven for plasmakoncentrationen længe nok til at give et pålideligt estimat af omfanget af absorptionen.
English: Confirmatory Pharmacokinetic Study (study code: 2009-2106)
Danish: Bekræftende farmakokinetisk undersøgelse (undersøgelseskode: 2009-2106)
English: The evaluation of the lag-time showed clinically negligible differences regarding the delay of absorption of pantoprazole from the two preparations.
Danish: Evalueringen af forsinkelsestiden viste klinisk insignifikante forskelle med hensyn til den forsinkede absorption af pantoprazol fra de to præparater.