FrancophonIA/ELRC3.0 huggingface dataset:
English: In the same non-clinical reproduction toxicity study with daclizumab, four out of seven lactating cynomolgus monkeys given a 5 - 10 fold multiple (10 mg/kg) of the normal human dose were found to secrete very low levels of daclizumab (0.17 - 0.28% of maternal serum levels) in breast milk.
Danish: I det samme prækliniske reproduktionstoxicitetsstudie med daclizumab, hvor cynomolgusaberne fik doser, der svarer til 5-10 gange normal human dosis (10 mg /kg), udskilte fire ud af syv aber meget lave koncentrationer af daclizumab (0,17 % - 0,28 % af maternelt serum niveau) i brystmælk.
English: The three year patient survival rate was significantly different between placebo and daclizumab in the double immunosuppressant trial (88% Vs. 96%; p = 0.017), but not in the triple immunosuppressant trial (94% Vs. 92%).
Danish: Tre års patientoverlevelsesgraden var signifikant forskellig mellem placebo og daclizumab i det dobbelte immunosuppressive forsøg (88% vs. 96%; p=0,017) men ikke i det tredobbelte immunosuppressive forsøg (94% vs. 92%).
English: Impaired healing (without infection) Chest pain
Danish: Svækket sårheling (uden infektion) Brystsmerter
English: Daclizumab*…………5 mg per 1 ml infusion
Danish: Daclizumab*………… 5 mg pr. 1 ml infusionsvæske
English: Application site reaction Pyrexia
Danish: Reaktioner på injektionsstedet Pyreksi
English: Zenapax does not increase this risk when it is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
Danish: Zenapax øger ikke denne risiko, , når det anvendes sammen med andre immunosuppresive lægemidler, inklusive ciclosporin og corticosteroider.
English: In rare cases severe hypersensitivity reactions following administration of Zenapax have been reported (see section 4.4).
Danish: I sjældne tilfælde er overfølsomhedsreaktioner efter administration af Zenapax blevet rapporteret (se pkt.
English: Anaphylactic reactions following the administration of proteins can occur.
Danish: Der kan optræde anafylaktiske reaktioner efter anvendelse af proteiner.
English: The incidence of stillbirth, caesarean section and breech delivery were comparable between the control and treatment groups.
Danish: Hyppigheden af dødfødte, kejsersnit og sædefødsler var sammenlignelig mellem kontrolgruppen og behandlingsgrupperne.
English: Store in a refrigerator (2 °C - 8 °C) Do not freeze
Danish: Opbevares i køleskab (2 °C - 8 °C) Må ikke nedfryses
English: Zenapax is contraindicated in patients with known hypersensitivity to daclizumab or to any excipients of this product (see section 6.1).
Danish: Zenapax er kontraindiceret til patienter med kendt overfølsomhed overfor daclizumab eller ethvert af dets andre indholdsstoffer (se pkt.
English: Serious adverse events were reported by 44.4% of the patients in the placebo-treated group and 39.9% of the patients in the Zenapax-treated group.
Danish: Alvorlige bivirkninger rapporteredes af 44,4% af patienterne i den placebobehandlede gruppe og af 39,9% af de behandlede patienter i Zenapaxgruppen.
English: Instructions for the preparation of Zenapax infusions are described in section 6.6.
Danish: Instruktion i hvordan Zenapax infusioner fremstilles, er beskrevet i pkt.
English: Do not use Zenapax - if you are allergic (hypersensitive) to daclizumab or to any of the other ingredients of Zenapax.
Danish: De bør ikke anvende Zenapax anvendes: - hvis De er allergisk (overfølsom) over for daclizumab eller et af de øvrige indholdsstoffer i
English: In a single randomized controlled clinical trial in cardiac transplant recipients which compared Zenapax to placebo, each used in combination with mycophenolate mofetil (CellCept 1.5 g bid), cyclosporine, and corticosteroids, there were more infection related deaths among patients who received Zenapax.
Danish: I en enkel randomiseret kontrolleret klinisk undersøgelse hos hjertetransplanterede patienter, der sammenlignede Zenapax overfor placebo, begge anvendt i kombination med mycophenolat mofetil (CellCept 1,5 g to gange daglig), cyclosporin og kortikosteroider var der flere infektionsrelaterede dødsfald hos patienter, der fik Zenapax.
English: However, of the 40 patients who received both Zenapax and antilymphocyte therapy, 8 (20.0%) died whereas of the 37 patients who received both placebo and antilymphocyte therapy, 2 (5.4%) died.
Danish: Hos de 40 patienter, der fik både Zenapax og antilymfocytterapi, var der 8 der døde (20,0%) mens hos de 37 patienter, der fik både placebo og antilymfocytterapi, var der 2 der døde (5,4%).
English: Zenapax 5 mg/ml concentrate for solution for infusion is a clear, colourless to slightly yellowish liquid is supplied in vials containing 5 ml of solution.
Danish: Zenapax 5 mg/ml koncentrat til infusionsvæske, opløsning er en klar, farveløs til svagt gullig opløsning som leveres i hætteglas indeholdende 5 ml opløsning.
English: A MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 February 1999
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: The volume of Zenapax containing the appropriate dose is added to 50 ml of sterile 0.9% saline solution and is administered intravenously over a 15 minute period.
Danish: Et volumen Zenapax indeholdende den nødvendige dosis sættes til 50 ml 0,9% steril natriumchloridopløsning og indgives intravenøst i løbet af 15 minutter.
English: In clinical trials involving renal allograft patients-treated with 1 mg/kg of Zenapax every 14 days for a total of 5 doses, average peak serum concentrations (mean ± standard deviation) rose between the first dose (21 ± 14 µg/ml) and fifth doses (32 ± 22 µg/ml).
Danish: I kliniske undersøgelser med nyretransplanterede patienter som blev behandlet med 1 mg/kg Zenapax hver anden uge, i alt 5 doser, steg gennemsnit peak-serumkoncentrationen (middel ± SD) fra den første dosis (21 ± 14 µg/ml) til den femte dosis (32 ± 22 µg/ml).
English: Rarely, allergic reactions (hypersensitivity) to Zenapax may occur.
Danish: Sjældent forekommer allergiske reaktioner (overfølsomhedsreaktioner) overfor Zenapax.
English: Zenapax is used together with other immunosuppressive drugs, including cyclosporine and corticosteroids.
Danish: Zenapax anvendes sammen med andre immunosuppressive lægemidler, inklusive ciclosporin og kortikosteroider.
English: The clinical manifestations of these reactions include hypotension, tachycardia, hypoxia, dyspnoea, wheezing, laryngeal oedema, pulmonary oedema, flushing, diaphoresis, temperature increase, rash and pruritus.
Danish: De kliniske tegn på disse reaktioner inkluderer hypotension, takykardi, hypoxi, dyspnø, hiven efter vejret, larynxødem, lungeødem, rødmen, diaforese, temperaturstigning, udslæt og kløe.
English: The twelve months mortality was 4.4% in the placebo- and 1.5% in the Zenapax-treated groups.
Danish: 12 måneders mortaliteten var 4,4% i placebogruppen og 1,5% i Zenapax gruppen.
English: - Store in the original package in order to protect from light.
Danish: - Opbevares i den originale emballage for at beskytte mod lys.
English: Abdominal pain upper (epigastric pain) Haemorrhoids
Danish: Abdominalsmerter Øvre abdominalsmerter (epigastrisk smerte)
English: Deaths occurring during the first 6 months post-transplant were reported in 3.4% of the placebo- and in 0.6% of the Zenapax-treated groups.
Danish: Dødsfald, der forekom i de første 6 måneder efter transplantationen, rapporteredes hos 3,4% i placebogruppen og hos 0,6% i Zenapax gruppen.
English: Combination Therapy in Renal Allograft Recipients
Danish: Kombinationsbehandling hos renal allotransplanterede
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/098/001
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use, for infusion after dilution Read the package leaflet before use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intravenøs infusion efter fortynding Læs indlægssedlen inden brug
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/098/002
English: HOW TO USE ZENAPAX
Danish: HVORDAN DE ANVENDER ZENAPAX
English: Daclizumab was not genotoxic in standard tests.
Danish: I de undersøgte standard tests var daclizumab ikke genotoksisk.
English: * Recombinant humanized IgG1 anti-Tac antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology.
Danish: * Rekombinant humaniseret IgG1 anti-Tac antistof fremstillet i en murin NSO myelom cellelinje under anvendelse af glutamin synthease (GS) ekspressions system (NS_GSO) ved rekombinant DNA teknologi.
English: The mean ± standard deviation trough serum concentration prior to fifth dose was 7.6 ± 4.0 µg/ml.
Danish: Den gennemsnitlige trough serumkoncentration ± SD før femte dosis var 7.6 ± 4.0 µg/ml.
English: No dosage adjustment is necessary for patients with severe renal impairment.
Danish: Dosisjustering er ikke nødvendig ved svær nedsat nyrefunktion.
English: Zenapax is contraindicated during lactation (see section 4.6).
Danish: Zenapax er kontraindiceret ved amning (se pkt.
English: Patients with severe renal impairment
Danish: Patienter med svær nedsat nyrefunktion
English: The type of infections reported was similar in both the Zenapax- and the placebo-treated groups.
Danish: Infektionstyperne var de samme i Zenapax- og placebogruppen.
English: METHOD OF ADMINISTRATION For intravenous use after dilution Read the package leaflet before use
Danish: ANVENDELSESMÅDE Til intravenøs anvendelse efter fortynding Læs indlægssedlen inden brug
English: Injury and poisoning Common
Danish: Skader og forgiftninger Almindelig Post-traumatisk smerte
English: Daclizumab is a humanised monoclonal antibody produced in a murine NSO myeloma cell line using a glutamine synthetase (GS) expression system (NS_GSO) by recombinant DNA technology.
Danish: Daclizumab er et humaniseret monoklonalt antistof fremstilles i en murin NSO myelom cellelinje under anvendelse af glutamin synthetase (GS) ekspressions system (NS_GSO) ved rekombinant DNA teknologi.
English: Anxiety Tremor
Danish: Ængstelse Rysten
English: In transplant recipients there is no experience of exposure to second or subsequent treatment courses using Zenapax.
Danish: Der er ingen erfaringer med behandling nr. 2 eller efterfølgende behandlinger hos transplantatmodtagere.
English: pyrosis) Abdominal distension Gastritis
Danish: Dyspepsi (inkl.halsbrand) Udspilet abdomen Gastritis
English: It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before intravenous administration to the patients.
Danish: Det skal fortyndes med 50 ml steril 0,9% natriumkloridopløsning før det gives intravenøst.
English: One vial with 5 ml concentrate for solution for infusion contains 25 mg daclizumab.
Danish: Et hætteglas med 5 ml koncentrat til infusionsvæske, opløsning indeholder 25 mg daclizumab.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Hvis en bivirkning bliver alvorlig eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør de fortælle det til Deres læge eller apotek.
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of 5 ml
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 1 hætteglas á 5 ml
English: After dilution an immediate use is recommended.
Danish: Efter fortynding anbefales det, at den tilberedte infusionsvæske anvendes med det samme.
English: HOW TO STORE ZENAPAX
Danish: HVORDAN DE OPBEVARER ZENAPAX
English: In a single dose toxicity study a dose of 125 mg/kg was administered intravenously to mice and showed no evidence of toxicity.
Danish: I en enkeltdosis toksikologisk undersøgelse på mus var der ingen tegn på toksicitet efter intravenøs indgift af 125 mg/kg.
English: Renal tubular necrosis Hydronephrosis Renal disorder (damage) Haemorrhage urinary tract Urinary retention Urinary tract disorder Oliguria
Danish: Renal tubulær nekrose Hydronephros Nyrelidelser (skader) Urinvejsblødning Urinretention
English: The mean trough serum concentration before the fifth dose was 5.0 + 2.7 µg/ml.
Danish: Middel trough serum koncentrationen var 5,0 ± 2,7 µg/ml før den femte dose.
English: No data are available for patients with severe hepatic impairment.
Danish: Der findes ingen data ved svær nedsat leverfunktion.
English: Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous Hydrochloric acid, concentrated Sodium hydroxide
Danish: Natriumdihydrogenphosphat, vandfri Dinatriumphosphat, vandfri Saltsyre, koncentreret Natriumhydroxid
English: Polysorbate 80, sodium chloride, sodium dihydrogen phosphate anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injection.
Danish: Polysorbat 80; natriumchlorid; natriumdihydrogenphosphat, vandfri; dinatriumphosphat, vandfri; saltsyre, koncentreret; natriumhydroxid; vand til injektionsvæsker.
English: PHARMACEUTICAL FORM AND CONTENTS 3 vials of 5 ml each
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 3 hætteglas á 5 ml
English: Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab
Danish: Zenapax 5 mg/ml koncentrat til infusionsvæske, opløsning Daclizumab
English: It should be diluted in 50 ml of sterile 0.9% sodium chloride solution before administration to patients.
Danish: Det skal fortyndes med 50 ml steril natriumchlorid opløsning før det gives til patienter.
English: Adverse events were reported by 95% of placebo and 96% of daclizumab treated patients.
Danish: Bivirkninger rapporteredes af 95% af patienterne i den placebobehandlede gruppe og af 96% af de behandlede patienter i Zenapaxgruppen.
English: - if you are breast-feeding.
Danish: - hvis De ammer
English: Women of childbearing potential must use an effective contraceptive method during Zenapax therapy and continue its use for an additional 4 months following the last dose of Zenapax.
Danish: Kvinder i den fødedygtige alder skal anvende sikker prævention under behandlingen med Zenapax og i 4 måneder efter, den sidste dosis af Zenapax er administreret.
English: Zenapax is a colourless solution provided as a single use vial.
Danish: Zenapax er en farveløs opløsning leveret i et hætteglas til éngangs brug.
English: Very common Musculoskeletal pain Back pain
Danish: Muskulo-skeletale smerter Rygsmerter
English: - The other ingredients are polysorbate 80, sodium chloride, sodium dihydrogen phosphate, anhydrous, disodium phosphate anhydrous, hydrochloric acid concentrated, sodium hydroxide, water for injections.
Danish: - Det aktive stof er daclizumab - De øvrige indholdsstoffer er polysorbat 80; natriumchlorid; natriumdihydrogenphosphat, vandfrit; dinatriumphosphat, vandfrit; saltsyre, koncentreret; natriumhydroxid; vand til injektionsvæsker.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zenapax 5 mg/ml concentrate for solution for infusion Daclizumab
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) Zenapax 5 mg/ml koncentrat til infusionsvæske, opløsning Daclizumab
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Daclizumab*…………5 mg per 1 ml infusion
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Daclizumab*…………5 mg pr. 1 ml infusionsvæske 1 hætteglas á 5 ml indeholder 25 mg daclizumab* (5 mg/ml).
English: Breath sounds abnormal Constipation Diarrhoea
Danish: Abnorme vejrtrækningslyde Forstoppelse
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/098/001 (single vial pack) EU/1/99/098/002 (3 vial pack)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/098/001 (pakning med 1 hætteglas)
English: NAME OF THE MEDICINAL PRODUCT Zenapax 5 mg/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Zenapax 5 mg/ml koncentrat til infusionsvæske, opløsning.
English: Psychiatric disorders
Danish: Urinvejssygdomme
English: Musculoskeletal, connective tissue and bone disorders
Danish: Sygdomme i bevægeapparat og bindevæv
English: Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.
Danish: Det skal anvendes sammen med immunosuppressiv terapi, inklusiv ciclosporin og kortikosteroider hos patienter som ikke er kraftigt immuniserede.
English: Renal failure
Danish: Kulderystelser Nyresvigt
English: BEFORE YOU USE ZENAPAX
Danish: HVAD DE SKAL GØRE, FØR DE BEGYNDER AT ANVENDE ZENAPAX
English: Lymphocele
Danish: Karsygdomme
English: Manufacturer Roche Pharma AG Emil-Barell-Strasse 1, D-79639 Grenzach-Wyhlen Germany
Danish: Fremstilleren Roche Pharma AG Emil-Barell-Strasse 1
English: Flatulence Rash
Danish: Almindelig Takykardi
English: Haemorrhage
Danish: Hæmorider
English: Respiratory tract congestion Rales
Danish: Tilstopning af luftvejene Rallen
English: please tell your doctor or pharmacist.
Danish: - Kontakt Deres læge eller apotek, hvis De har yderligere spørgsmål.
English: aggravated) Hypotension
Danish: forværret)
English: Oedema
Danish: Nattesved
English: This justification is based on the following arguments:
Danish: Begrundelsen bygger på følgende argumenter:
English: In conclusion, the applicant's arguments are not well set out.
Danish: Som konklusion er ansøgerens argumentation ikke velunderbygget.
English: However, the difference in concentration of the active substance also needs to be considered.
Danish: Der må imidlertid også tages hensyn til forskellen i koncentrationen af det aktive stof.
English: Having considered all data submitted the CVMP concluded that:
Danish: Efter at have gennemgået alle de forelagte oplysninger konkluderede CVMP, at:
English: The reference Member State (RMS) is the Netherlands and 12 concerned Member States (CMS) are involved: Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain and the United Kingdom.
Danish: Referencemedlemsstaten er Nederlandene, og de 12 berørte medlemsstater er: Østrig, Belgien, Tjekkiet, Danmark, Frankrig, Tyskland, Ungarn, Irland, Italien, Polen, Spanien og Det Forenede Kongerige.
English: Some differences in pharmacokinetic parameters are attributed to different size/age of animal.
Danish: Nogle af forskellene i farmakokinetiske parametre tilskrives forskelle i dyrenes størrelse/alder.
English: Scientific conclusions and grounds for refusal of the granting of the marketing authorisation
Danish: Videnskabelige konklusioner og begrundelse for afslag på ansøgningen om markedsføringstilladelse
English: This was clear from the variability shown in the data and referred to by the applicant.
Danish: Dette fremgik klart af resultaternes variabilitet, der også blev omtalt af ansøgeren.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from the Netherlands.
Danish: Efter gennemgang af de forelagte oplysninger konkluderede udvalget følgende vedrørende de spørgsmål, der var rejst i henvisningen fra Nederlandene:
English: The applicant did not comment on the level of confidence that can be attained with the results of the residues study.
Danish: Ansøgeren kommenterede ikke spørgsmålet om, hvilken grad af pålidelighed der kan opnås ved hjælp af resultaterne af restkoncentrationsundersøgelsen.
English: This is the standard that has been generally requested from applicants seeking to change the strength of an injectable formulation (other than for intravenous route).
Danish: Dette er den standard, der sædvanligvis er blevet krævet fra ansøgere, der ønsker at ændre styrken af et injektionspræparat (bortset fra intravenøs administration).
English: The application was submitted as a generic hybrid application under Article 13(3), as there is currently no authorised product with the same concentration of meloxicam.
Danish: Ansøgningen blev indgivet som en generisk hybrid ansøgning i henhold til artikel 13, stk. 3, da der ikke på nuværende tidspunkt er godkendt andre produkter med denne koncentration af meloxicam.
English: • Even if the formulations were inequivalent, the lack of bioequivalence would not be clinically relevant due to a wide therapeutic window.
Danish: • Selv hvis formuleringerne ikke var ækvivalente, ville den manglende bioækvivalens ikke være kli nisk relevant, da det terapeutiske vindue er bredt.
English: I. Effect of comparing results from separately conducted studies The applicant has provided references that broadly show comparability of pharmacokinetic data derived in studies conducted at different times.
Danish: I. Virkningen af at sammenligne resultater fra separat udførte undersøgelser Ansøgeren har forelagt bred dokumentation for sammenligneligheden af farmakokinetiske data i undersøgelser udført på forskellige tidspunkter.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, måldyrearter, administrationsvej og ansøger om markedsføringstilladelse i medlemsstaterne
English: An insufficient number of animals was used in each of the residues studies to achieve the required precision.
Danish: I hver restkoncentrationsundersøgelse var antallet af dyr utilstrækkeligt til at opnå den nødvendige nøjagtighed.
English: Hence, the safety and efficacy of the product remains unknown for pigs.
Danish: Produktets sikkerhed og virkning ved anvendelse til svin kendes derfor ikke.
English: Agreement was reached during the decentralised procedure with regard to data submitted to support the safety and the efficacy concerning target species cattle and horses.
Danish: Ved den decentrale procedure opnåedes enighed om de forelagte data vedrørende sikkerheden og virkningen hos måldyrearterne kvæg og heste.
English: The benefit-risk balance for pigs remains inconclusive in absence of adequate information on the safety and efficacy of the product.
Danish: Om benefit/risk-forholdet hos svin kan der fortsat ikke drages konklusioner i mangel af fyldestgørende oplysninger om produktets sikkerhed og virkning.
English: The CVMP does not accept that the comparison of residues from two different products at a single time point allows conclusions to be drawn about the blood concentration-time profile, or that the studies provide an accurate estimate of relative bioavailability.
Danish: CVMP godtager ikke, at der ved sammenligning af restkoncentrationerne af to forskellige produkter på et enkelt tidspunkt skulle kunne drages konklusioner om blodkoncentrationskurven, eller at undersøgelserne skulle give mulighed for et nøjagtigt estimat over den relative biotilgængelighed.
English: The Committee considered if the results from a residue depletion study may be used as a surrogate for data from a bioequivalence study.
Danish: Udvalget vurderede, om resultaterne af en restkoncentrationsundersøgelse kan anvendes som surrogat for data fra en bioækvivalensundersøgelse.
English: All references to the target species pigs should be removed from the final versions of the summary of product characteristics, labelling and package leaflet agreed during the Coordination group procedure.
Danish: Al omtale af måldyrearten svin skal slettes i de endelige versioner af produktresuméet, etiketteringen og indlægssedlen som vedtaget ved behandlingen i koordinationsgruppen.
English: The applicant considered it is not necessary to prove bioequivalence for this hybrid application but that a justification of therapeutic equivalence is sufficient.
Danish: Ansøgeren fandt det ikke nødvendigt at godtgøre bioækvivalens i forbindelse med denne hybridansøgning, men anså en begrundelse for terapeutisk ækvivalens for tilstrækkelig.