FrancophonIA/ELRC3.0 huggingface dataset:
English: referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via drinking water
Danish: Udtalelse som følge af en sag indbragt i henhold til artikel 351 om alle styrker af vandopløselige pulvere og orale opløsninger, som indeholder doxycyclinhyclat indiceret til anvendelse hos fjerkræ og beregnet til indgivelse via drikkevand
English: London, 19 December 2008 Doc.
Danish: London, den 19. december 2008 Dok.
English: The CHMP was also concerned about the medicine's safety.
Danish: CHMP var også betænkelig ved lægemidlets sikkerhed.
English: The application was at day 173 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 173, da virksomheden trak sin ansøgning tilbage.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Danish: Brevet fra virksomheden, hvori EMEA underrettes om tilbagetrækning af ansøgningen, findes her.
English: Questions and answers on the withdrawal of the marketing application for Theraloc
Danish: Spørgsmål og svar i forbindelse med tilbagetrækning af ansøgningen om markedsføringstilladelse for Theraloc
English: Theraloc was not compared with any other treatment.
Danish: Theraloc blev ikke sammenlignet med nogen anden behandling.
English: The main measure of effectiveness was the number of patients who responded to treatment.
Danish: Det primære effektmål var antallet af patienter, som "responderede" på behandlingen.
English: In addition, it was not clear whether all the patients included in the study had resistant or recurrent disease.
Danish: Derudover var det uklart, om alle patienterne i undersøgelsen havde resistent eller recidiverende sygdom.
English: International non-proprietary name (INN): nimotuzumab
Danish: Internationalt fællesnavn (INN): nimotuzumab
English: What is Theraloc?
Danish: Hvad er Theraloc?
English: A patient was classified as a responder if the tumours disappeared, shrank or stayed the same size.
Danish: En patient blev klassificeret som responderende, hvis tumorerne forsvandt, blev mindre eller bevarede samme størrelse.
English: The effects of Theraloc were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Theraloc blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: It contains the active substance nimotuzumab.
Danish: Det indeholder det aktive stof nimotuzumab.
English: Theraloc was designated as an orphan medicinal product on 2 September 2004.
Danish: Theraloc blev udpeget som lægemiddel til sjældne sygdomme den 2. september 2004.
English: No information was provided on whether the body would produce antibodies against the medicine and there was a high rate of serious side effects.
Danish: Der blev ikke fremlagt nogen oplysninger om, hvorvidt kroppen ville danne antistoffer mod lægemidlet, og der sås en høj frekvens af alvorlige bivirkninger.
English: When activated, EGFR helps the tumour cells grow, multiply and spread.
Danish: Når det aktiveres, hjælper EGFR tumorcellerne til at vokse, dele sig og brede sig.
English: Theraloc was to be used when the glioma was ‘resistant' (it did not respond to other treatments) or ‘recurrent' (it had come back after previous treatment).
Danish: Theraloc skulle anvendes, hvis et gliom var blevet "resistent" (ikke responderede på andre behandlinger) eller "recidiverende" (var vendt tilbage efter tidligere behandling).
English: Glioma is a type of brain tumour that begins in ‘glial' cells (the cells that surround and support nerve cells).
Danish: Gliom er en type af hjertetumor, som starter i "gliale" celler (celler, som omgiver og støtter nerveceller).
English: What was Theraloc expected to be used for?
Danish: Hvad forventedes Theraloc anvendt til?
English: On 1 December 2008, Oncoscience AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Theraloc, for the treatment of children and adolescents with resistant or recurrent high-grade glioma.
Danish: Den 1. december 2008 meddelte Oncoscience AG officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Theraloc til behandling af børn og unge med resistent eller recidiverende højt differentieret gliom.
English: The active substance in Theraloc, nimotuzumab, is a monoclonal antibody.
Danish: Det aktive stof i Theraloc, nimotuzumab, er et monoklonalt antistof.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Danish: Et monoklonalt antistof er et antistof (en type protein), som er i stand til at genkende og binde sig til en særlig struktur, der kaldes et antigen, som findes på visse celler i kroppen.
English: Nimotuzumab binds to an antigen called epidermal growth factor receptor (EGFR), a protein that can be found on the surface of certain tumour cells.
Danish: Nimotuzumab binder sig til et antigen kaldet receptoren for den epidermale vækstfaktor (EGFR), som er et protein, der findes på overfladen af visse tumorceller.
English: Theraloc has been studied in one main study involving 47 children and adolescents with glioma who had no treatments available that could cure their disease.
Danish: Theraloc blev undersøgt i én hovedundersøgelse med 47 børn og unge med gliom, for hvem der ikke forelå en behandling, der kunne helbrede deres sygdom.
English: Theraloc was expected to be used to treat adolescents and children from the age of three years with high-grade glioma.
Danish: Theraloc forventedes anvendt til behandling af unge og børn fra 3 år med højt differentieret gliom.
English: How is Theraloc expected to work?
Danish: Hvordan forventes Theraloc at virke?
English: Theraloc is a concentrate that is made up into a solution for infusion (drip into a vein).
Danish: Theraloc er et koncentrat, der bruges til fremstilling af en infusionsopløsning (intravenøst drop).
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Theraloc could not have been approved for the treatment of children and adolescents with recurrent high-grade glioma.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål havde CHMP på tidspunktet for tilbagetrækningen af ansøgningen visse betænkeligheder og var af den foreløbige opfattelse, at Theraloc ikke kunne have været godkendt til behandling af børn og unge med recidiverende højt differentieret gliom.
English: The Committee had concerns that the benefits of Theraloc had not been demonstrated, because the main study did not show a benefit in terms of survival and none of the patients treated with Theraloc showed a complete disappearance of the tumours.
Danish: Udvalget havde betænkeligheder ved, at fordelene ved Theraloc ikke var blevet påvist, fordi hovedundersøgelsen ikke viste en gavnlig virkning med hensyn til overlevelse, og fordi ingen af de patienter, der fik behandling med Theraloc, blev fuldstændig helbredt for deres tumorer.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Theraloc?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Theraloc eller i programmer for anvendelse af Theraloc med særlig udleveringstilladelse?
English: The CHMP was concerned that the company had not supplied sufficient evidence to demonstrate that Theraloc could be made in a reliable manner, and that insufficient information was provided on the way the product was treated by the body.
Danish: CHMP var betænkelig ved, at virksomheden ikke havde fremlagt tilstrækkelige dokumentation for, at Theraloc kunne fremstilles på en pålidelig måde, og at der ikke var fremlagt tilstrækkelige oplysninger om, hvordan kroppen reagerede på lægemidlet.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Theraloc had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP således af den opfattelse, at fordelen ved Theraloc ikke var blevet tilstrækkeligt påvist, og at eventuelle fordele ikke opvejede de påviste risici.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Theraloc.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser med Theraloc eller i programmer for anvendelse med særlig udleveringstilladelse.
English: By blocking EGFR, nimotuzumab was expected to slow down the progression of glioma.
Danish: Det forventedes, at nimotuzumab ved at blokere EGFR kunne bremse udviklingen af et gliom.
English: This will be checked by your doctor.
Danish: Det vil din læge undersøge.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal lægemidlet bruges med det samme.
English: 2304 Orth an der Donau AUSTRIA
Danish: 2304 Orth an der Donau ØSTRIG
English: Check that all the solvent has transferred.
Danish: Kontrollér, at al solvensen er overført.
English: EXP: Use immediately or within 3 hours after reconstitution.
Danish: EXP: Bruges straks eller inden for 3 timer efter rekonstitution.
English: This is particularly important if you are having major surgery.
Danish: Det er særligt vigtigt, hvis du skal gennemgå en større operation.
English: Filtration does not influence dosage calculations.
Danish: Filtrering påvirker ikke dosisberegningerne.
English: Uferstrasse 15
Danish: Uferstraße 15
English: It is used when treatment with another medicine, desmopressin, is not effective or cannot be given.
Danish: Det bruges, når behandling med en anden medicin, desmopressin, ikke virker eller ikke kan gives.
English: Tel: +44(0)1256 894 959 e-mail: medinfoEMEA@shire.com
Danish: Tlf.: +44(0)1256 894 959 e-mail: medinfoEMEA@shire.com
English: The patient should be observed for any immediate reaction.
Danish: Patienten skal observeres for eventuelle umiddelbare reaktioner.
English: - Proceed with the next infusion as scheduled and continue as advised by your doctor.
Danish: - Fortsæt med den næste infusion som planlagt, og fortsæt derefter som anvist af lægen.
English: ATC code: B02BD10
Danish: ATC-kode: B02BD10
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal gældende medicinsk standard for shockbehandling iværksættes.
English: This should be done right away to keep the liquid free of germs.
Danish: Dette skal gøres med det samme for at holde væsken fri for bakterier.
English: Minimum Duration of treatment
Danish: Mindste varighed af behandling
English: Wash your hands and put on clean exam gloves (the use of gloves is optional).
Danish: Vask hænder, og tag rene undersøgelseshandsker på (brug af handsker er valgfri).
English: Your doctor may adjust the dose according to your laboratory results.
Danish: Lægen vil muligvis justere din dosis efter dine laboratorieresultater.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Danish: Da disse reaktioner rapporteres frivilligt fra en population af uvis størrelse, er det ikke altid muligt at give en pålidelig vurdering af hyppigheden eller fastlægge en årsagssammenhæng med eksponeringen for medicinen.
English: The reconstituted product should be inspected visually prior to administration.
Danish: Det rekonstituerede lægemiddel skal inspiceres visuelt før administration.
English: Lack of VWF increases the tendency to bleed.
Danish: Mangel på VWF øger tendensen til blødning.
English: Frequency categories are defined according to the following convention: 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: Hyppighedskategorier er defineret i henhold til følgende konvention: 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: Patients should be closely monitored and carefully observed for any symptoms throughout the infusion period.
Danish: Patienterne skal overvåges tæt og omhyggeligt observeres for eventuelle symptomer i hele infusionsperioden.
English: Known allergic reaction to mouse or hamster proteins.
Danish: Kendt allergisk reaktion over for muse- eller hamsterprotein.
English: If such inhibitors occur, the condition may manifest itself as an inadequate clinical response.
Danish: Hvis disse inhibitorer opstår, kan tilstanden komme til udtryk som utilstrækkeligt klinisk respons.
English: If any of these symptoms occur, stop the infusion immediately and contact your doctor.
Danish: Hvis nogen af disse symptomer opstår, skal du stoppe infusionen med det samme og kontakte lægen.
English: Discard after three hours.
Danish: Kasseres efter tre timer.
English: In addition, one post-marketing case of DVT has been reported spontaneously for an elderly patient.
Danish: Desuden er der efter markedsføringen blevet rapporteret om ét spontant tilfælde af DVT hos en ældre patient.
English: Patients treated with this product may develop hypersensitivity reactions to these non-human mammalian proteins.
Danish: Patienter, der behandles med dette lægemiddel, kan udvikle overfølsomhedsreaktioner over for disse ikke-humane pattedyrsproteiner.
English: Be careful not to touch the clear plastic spike.
Danish: Sørg for ikke at røre ved den gennemsigtige plastikspids.
English: You will be monitored carefully for the possibility of having developed these inhibitors.
Danish: Du vil blive overvåget nøje for det tilfælde, at du udvikler disse inhibitorer.
English: Neutralizing antibodies (Inhibitors)
Danish: Neutraliserende antistoffer (inhibitorer)
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler bør navn og batchnummer på det administrerede lægemiddel registreres tydeligt.
English: The rate of administration should be slow enough to ensure the comfort of the patient, up to a maximum of 4 mL/min.
Danish: Indgivelseshastigheden skal være tilstrækkelig langsom til, at patientens velbefindende sikres, op til maksimalt 4 ml/min.
English: This should be taken into consideration if you are on a controlled sodium diet.
Danish: Dette skal tages i betragtning, hvis du er på en natriumkontrolleret diæt.
English: Dosing guidance should be done based on the IR.
Danish: Doseringsvejledning skal foretages på basis af IR.
English: In the 2 spontaneous post-marketing cases reported, the symptoms resolved and the patients fully recovered in 20 minutes to 4 hours upon stopping the infusion.
Danish: I de 2 spontane tilfælde rapporteret efter markedsføringen forsvandt symptomerne, og patienterne kom sig helt på 20 minutter til 4 timer efter infusionens ophør.
English: Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long.
Danish: Lægen beregner den dosis, der er mest passende for dig, hvor ofte du skal have VEYVONDI og hvor længe.
English: Severe symptoms, including difficulty in breathing and dizziness, require prompt emergency treatment.
Danish: Svære symptomer, herunder vejrtrækningsbesvær og svimmelhed, kræver akut behandling omgående.
English: These could be early symptoms of a hypersensitivity reaction.
Danish: Dette kan være tidlige symptomer på en overfølsomhedsreaktion.
English: It is not uncommon for a few flakes or particles to remain in the product vial after reconstitution.
Danish: Det er ikke ualmindeligt, at der er nogle få flager eller partikler tilbage i hætteglasset med lægemiddel efter rekonstitution.
English: FVIII products may contain varying amounts of VWF.
Danish: FVIII-lægemidler kan indeholde varierende mængder af VWF.
English: Your doctor will calculate your dose of VEYVONDI (in international units or IU).
Danish: Lægen vil beregne din dosis af VEYVONDI (i internationale enheder eller IE).
English: Clb IR at Cmax c
Danish: IR ved Cmax c
English: - This medicine is for single use only.
Danish: - Dette lægemiddel er kun til engangsbrug.
English: This is to be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning hos patienter, der er på en natriumkontrolleret diæt.
English: You can have an allergic reaction to VEYVONDI.
Danish: Du kan få en allergisk reaktion over for VEYVONDI.
English: The complete dose of VEYVONDI should be administered followed by rFVIII within 10 minutes.
Danish: Den fulde VEYVONDI-dosis skal administreres efterfulgt af rFVIII inden for 10 minutter.
English: In a human ex vivo placenta perfusion model, it has been demonstrated that VEYVONDI does not cross the human placenta barrier.
Danish: I en human ex vivo-placentaperfusionsmodel er det påvist, at VEYVONDI ikke krydser den humane placentabarriere.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at 25°C.
Danish: Det er påvist, at væskens kemiske og fysiske holdbarhed, mens den er i brug, er 3 timer ved 25 °C.
English: If you use VEYVONDI at home, your doctor will make sure that you are shown how to infuse it and how much to use.
Danish: Hvis du bruger VEYVONDI hjemme, vil din læge sørge for, at du får vist, hvordan du skal give infusionen, og hvor meget du skal have.
English: A combination with a FVIII product containing VWF would pose an additional risk of thrombotic events.
Danish: En kombination med et FVIII-præparat, der indeholder VWF, vil udgøre en yderligere risiko for trombotiske hændelser.
English: There is a low risk that you may experience a hypersensitivity reaction (a severe, sudden allergic reaction) to VEYVONDI.
Danish: Der er en lav risiko for, at du kan få en overfølsomhedsreaktion (en alvorlig, pludselig allergisk reaktion) på VEYVONDI.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis blandingen ikke bruges omgående, er opbevaringstiderne og forholdene inden brugen brugerens ansvar, og den kan normalt ikke opbevares længere end 24 timer ved 2 til 8 °C, medmindre rekonstitution har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Therefore, patients experiencing hypersensitivity or anaphylactic reactions should be tested and evaluated for the presence of an inhibitor.
Danish: Alle patienter, der oplever overfølsomhed eller anafylaktiske reaktioner, bør derfor testes og vurderes for tilstedeværelsen af inhibitor.
English: If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of VEYVONDI and provide appropriate supportive care.
Danish: Hvis der forekommer tegn og symptomer på svære allergiske reaktioner, skal administrationen af VEYVONDI straks afbrydes og relevant understøttende behandling iværksættes.
English: VEYVONDI is a rVWF that contains ultra-large multimers in addition to all of the multimers found in plasma as it is not exposed to proteolysis by ADAMTS13 during the manufacturing process.
Danish: VEYVONDI er en rVWF, der indeholder ultrastore multimerer ud over de multimerer, der findes i plasma, da det ikke eksponeres for proteolyse af ADAMTS13 i fremstillingsprocessen.
English: Sustained increase of FVIII:C was observed by six hours after a single infusion of VEYVONDI.
Danish: En vedvarende stigning i FVIII:C blev observeret seks timer efter en enkelt infusion af VEYVONDI.
English: In all three studies, subjects were evaluated in the non-bleeding state.
Danish: I alle tre studier blev forsøgspersonerne evalueret, mens der ikke forekom blødninger.
English: General instructions
Danish: Generelle instruktioner
English: If you forget to use VEYVONDI - Do not infuse a double dose to make up for a forgotten dose.
Danish: Hvis du har glemt at bruge VEYVONDI - Du må ikke tilføre en dobbeltdosis som erstatning for den glemte dosis.
English: Subsequent infusions:
Danish: Efterfølgende infusioner:
English: You might need a higher dose of VEYVONDI, or a higher dose of factor VIII, or even a different medicine to control bleedings.
Danish: Du skal måske have en højere dosis VEYVONDI eller en højere dosis faktor VIII, eller en helt anden medicin til at kontrollere blødningerne.
English: Animal reproduction studies have not been conducted with VEYVONDI.
Danish: Der er ikke udført dyrereproduktionsstudier med VEYVONDI.
English: The first dose of VEYVONDI should be 40 to 80 IU/kg body weight.
Danish: Den første dosis VEYVONDI bør være 40 til 80 IE/kg legemsvægt.
English: In patients with the disease the blood does not clot normally leading to a prolonged bleeding time.
Danish: Hos patienter, der har sygdommen, størkner blodet ikke normalt, og blødninger varer længere.
English: Start of treatment
Danish: Behandlingsstart
English: Detailed instructions for reconstitution and admnistration are given at the end of this package leaflet.
Danish: Detaljeret instruktion i blanding og indgivelse findes til sidst i denne indlægsseddel.
English: Patients developing inhibitors
Danish: Patienter, der udvikler inhibitorer
English: Administered intravenously, VEYVONDI binds to endogenous factor VIII (which is produced normally by the patient), and by stabilising this factor, avoids its rapid degradation.
Danish: Ved intravenøs administration bindes VEYVONDI til endogen faktor VIII (som patienten danner normalt), og ved at stabilisere denne faktor undgås det, at den hurtigt nedbrydes.
English: Adverse Reaction by Preferred Term (PT)
Danish: Bivirkning efter foretrukken term
English: Table 5 Pharmacokinetic Assessment of VWF:RCo f
Danish: Tabel 5 Farmakokinetisk vurdering af VWF:RCo f
English: The clinical safety, efficacy and PK data were assessed in 3 completed trials, (070701, 071001 and 071101) which enrolled patients with VWD.
Danish: Den kliniske sikkerhed, virkning og de farmakokinetiske data blev vurderet i 3 afsluttede forsøg (070701, 071001 og 071101), der inkluderede patienter med VWD.
English: Therefore, patients at risk have to be monitored for early signs of thrombosis, and prophylaxis measures against thromboembolism should be instituted according to current recommendations and standard of care.
Danish: Patienter i risikogruppen skal derfor monitoreres for tidlige tegn på trombose, og profylaktiske foranstaltninger mod tromboemboli bør iværksættes i henhold til gældende anbefalinger og standardprocedurer.
English: Mean (95% CI) SD
Danish: Gennemsnit (95 % CI) SD
English: Please refer to Table 3 for treatment recommendations for subsequent maintenance doses.
Danish: Se tabel 3 for behandlingsanbefalinger til efterfølgende vedligeholdelsesdoser.
English: VEYVONDI should not be used in the treatment of Haemophilia A.
Danish: VEYVONDI må ikke anvendes til behandling af hæmofili A.
English: Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.
Danish: Tag kanylen ud af venen, og brug steril gaze til at lægge tryk på infusionsstedet i flere minutter.
English: Von Willebrand disease is an inherited bleeding disorder caused by the lack or an insufficient amount of von Willebrand factor.
Danish: Von Willebrands sygdom er en arvelig blødersygdom, der skyldes mangel på eller en utilstrækkelig mængde af von Willebrand-faktor.