FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Bortezomib Sun will supply educational material to healthcare professionals on making up and giving the injection, calculating the dose, and prescribing and giving the correct treatment for patients receiving blood stem-cell transplantation.
Danish: Den virksomhed, der markedsfører Bortezomib Sun, vil udarbejde informationsmateriale til sundhedspersoner vedrørende klargøring og indgivelse af injektionen, beregning af dosen samt ordinering og håndtering af den korrekte behandling til patienter, der gennemgår transplantation af blodstamceller.
English: Other information about Bortezomib Sun
Danish: Andre oplysninger om Bortezomib Sun
English: Therefore, the CHMP's view was that, as for Velcade, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Velcade.
English: Bortezomib Sun must not be given by other routes.
Danish: Bortezomib Sun må ikke gives på andre måder.
English: What measures are being taken to ensure the safe and effective use of Bortezomib Sun?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Bortezomib Sun?
English: Bortezomib Sun is a cancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Danish: Bortezomib Sun er et kræftlægemiddel, der anvendes til behandling af myelomatose, som er blodkræft, hos følgende patientgrupper:
English: When given into a vein, the solution is injected through a catheter (a thin sterile tube).
Danish: Når opløsningen gives i en vene, sker det ved en injektion gennem et kateter (en tynd, steril slange).
English: Bortezomib Sun is a ‘generic medicine'.
Danish: Bortezomib Sun er et "generisk lægemiddel".
English: Because Bortezomib Sun is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Bortezomib Sun er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The medicine can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy.
Danish: Bortezomib Sun udleveres kun efter recept, og behandlingen bør kun indledes og gives under tilsyn af en læge med erfaring i anvendelse af kemoterapi til behandling af kræft.
English: The active substance in Bortezomib Sun, bortezomib, is a proteasome inhibitor.
Danish: Det aktive stof i Bortezomib Sun, bortezomib, er en proteasomhæmmer.
English: Bortezomib Sun contains the active substance bortezomib.
Danish: Bortezomib Sun indeholder det aktive stof bortezomib.
English: Bortezomib Sun is also used to treat mantle cell lymphoma, another blood cancer, in untreated adults who cannot have blood stem-cell transplantation.
Danish: Bortezomib Sun anvendes desuden til behandling af en anden form for blodkræft, mantelcellelymfom, hos ubehandlede voksne, som ikke kan få transplantation af blodstamceller.
English: For more information on the use of Bortezomib Sun see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Bortezomib Sun fremgår af produktresuméet (også en del af denne EPAR).
English: Doses of Bortezomib Sun are given with rest periods between doses, in treatment cycles of three to six weeks depending on whether Bortezomib Sun is given alone or in combination with other medicines.
Danish: Bortezomib Sun-doser gives i behandlingsforløb på tre til seks uger, afhængigt af om lægemidlet gives alene eller i kombination med andre lægemidler, med hvileperioder mellem doserne.
English: For more information about treatment with Bortezomib Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Bortezomib Sun, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the benefits and risks of Bortezomib Sun?
Danish: Hvilken fordel og risiko er der forbundet med Bortezomib Sun?
English: • previously untreated adults who cannot have high-dose chemotherapy with blood stem-cell transplantation.
Danish: • tidligere ubehandlede voksne, som ikke kan få højdosiskemoterapi med transplantation af blodstamceller.
English: Bortezomib Sun is available in vials as a 3.5 mg powder to be made up into a solution for injection into a vein or under the skin.
Danish: Bortezomib Sun fås i hætteglas med 3,5 mg pulver, der blandes til en opløsning til injektion i en vene eller under huden.
English: It is not intended to provide practical advice on how to use Bortezomib Sun.
Danish: Det er ikke en praktisk vejledning i, hvordan Bortezomib Sun bør anvendes.
English: The company provided data from the published literature on bortezomib.
Danish: Virksomheden fremlagde data fra faglitteraturen om bortezomib.
English: What is Bortezomib Sun and what is it used for?
Danish: Hvad er Bortezomib Sun, og hvad anvendes det til?
English: • previously untreated adults who are going to receive high-dose chemotherapy followed by blood stem-cell transplantation.
Danish: • tidligere ubehandlede voksne, som skal gennemgå højdosiskemoterapi efterfulgt af en transplantation af blodstamceller.
English: For practical information about using Bortezomib Sun, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Bortezomib Sun, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For mantle cell lymphoma, Bortezomib Sun is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Danish: Ved mantelcellelymfom anvendes Bortezomib Sun i kombination med rituximab, cyclophosphamid, doxorubicin og prednison.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bortezomib Sun have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Bortezomib Sun.
English: In these patients, Bortezomib Sun is used in combination with melphalan and prednisone;
Danish: Hos disse patienter anvendes Bortezomib Sun i kombination med melphalan og prednison
English: Why is Bortezomib Sun approved?
Danish: Hvorfor blev Bortezomib Sun godkendt?
English: In this group of patients, Bortezomib Sun is used in combination with dexamethasone, or with dexamethasone plus thalidomide.
Danish: Inden for denne gruppe patienter anvendes Bortezomib Sun i kombination med dexamethason eller dexamethason og thalidomid.
English: Bortezomib Sun is either used on its own in these patients or in combination with pegylated liposomal doxorubicin or dexamethasone;
Danish: Hos disse patienter anvendes Bortezomib Sun enten alene eller i kombination med pegyleret liposomal doxorubicin eller dexamethason
English: How has Bortezomib Sun been studied?
Danish: Hvordan blev Bortezomib Sun undersøgt?
English: How is Bortezomib Sun used?
Danish: Hvordan anvendes Bortezomib Sun?
English: How does Bortezomib Sun work?
Danish: Hvordan virker Bortezomib Sun?
English: By 25th November 2013 at the latest
Danish: Senest den 25. november 2013
English: The products with only obstetric indications and for which revocation is applicable (instead of variation to the terms of the marketing authorisation) should be recalled from the market by the Marketing Authorisation Holders by 25th November 2013 at the latest.
Danish: Produkter, der kun har obstetriske indikationer, og for hvilke markedsføringstilladelsen skal inddrages (i stedet for at få ændret betingelserne for markedsføringstilladelsen), skal tages af markedet af indehaverne af markedsføringstilladelse senest den 25. november 2013.
English: Within 30 days after CMDh agreement
Danish: Senest 30 dage efter vedtagelsen i CMDh
English: Annex IV Conditions to the marketing authorisation
Danish: Bilag IV Betingelser for markedsføringstilladelsen
English: DHPC Communication circulation according to the CMDh agreed communication plan and conditions.
Danish: Udsendelse af direkte henvendelse til sundhedspersoner i henhold til den kommunikationsplan og de betingelser, der er vedtaget af CMDh.
English: National Competent Authorities (NCAs) of Member States or Reference Member States (RMS) where applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Danish: De nationale kompetente myndigheder i medlemsstaterne eller i givet fald i referencemedlemsstaterne sikrer, at indehaveren af markedsføringstilladelsen opfylder følgende betingelser:
English: The detailed grounds for re-examination were submitted on 2 May 2012.
Danish: Den detaljerede begrundelse for den fornyede overvejelse blev indsendt den 2. maj 2012.
English: in which D is the number of molecules.
Danish: hvor D er antallet af molekyler.
English: A number of deficiencies with the study were noted.
Danish: Der blev konstateret en række mangler i denne undersøgelse.
English: The following equation describes the elimination process in the terminal phase:
Danish: Følgende ligning beskriver eliminationsprocessen i terminalfasen:
English: These are presented in the table below.
Danish: Disse er angivet i nedenstående tabel.
English: This led to the identification of 251 products.
Danish: Der blev identificeret 251 lægemidler.
English: The Committee was also asked to recommend whether the marketing authorisations should be maintained, varied, suspended or withdrawn.
Danish: Udvalget blev desuden anmodet om at fremsætte en anbefaling om, hvorvidt markedsføringstilladelserne bør opretholdes, ændres, suspenderes eller inddrages.
English: Applicant/ Marketing Authorisation Holder
Danish: Ansøger/indehaver af markedsføringstilladelse
English: The CVMP collected information from national competent authorities on veterinary medicinal products containing these substances.
Danish: CVMP indsamlede oplysninger fra de kompetente nationale myndigheder om veterinærlægemidler indeholdende disse stoffer.
English: Consideration of realistic safe time spans
Danish: Overvejelse af realistiske sikre tidsintervaller
English: The CVMP recommendation does not represent a formal withdrawal period.
Danish: CVMP's anbefaling repræsenterer ikke en formel tilbageholdelsestid.
English: These cases were considered to have resulted from animals grooming each other.
Danish: Disse tilfælde menes at skyldes, at dyrene soignerer hinanden.
English: This time period can be rounded up to 1 year.
Danish: Dette tidsrum kan rundes op til 1 år.
English: It should be noted that the present referral procedure focuses on consumer safety.
Danish: Det bemærkes, at denne indbringelsesprocedure vedrører forbrugernes sikkerhed.
English: 5 Pharmaceutical form for oral administration - bolus
Danish: 5Lægemiddelform til oral administration - bolus
English: 20093 Cologno Monzese (MI) ITALY
Danish: 20093 Cologno Monzese (MI) ITALIEN
English: It is assumed that the recommendations are sufficiently conservative to overcome any concerns relating to these issues.
Danish: Det forudsættes, at anbefalingerne er tilstrækkeligt restriktive til at imødekomme eventuelle betænkeligheder vedrørende disse spørgsmål.
English: The longest half-life reported for marker residue was 25 days.
Danish: Den længste beskrevne halveringstid for restmarkøren var 25 dage.
English: Active substance
Danish: Aktivt stof
English: 2909 LD Capelle a/d Ijssel THE NETHERLANDS
Danish: 2909 LD Capelle a/d Ijssel NEDERLANDENE
English: The evaluation detailed in this opinion attempts to address the issue raised by the European Commission on the basis of the available data.
Danish: I vurderingen i denne udtalelse tilstræbes det at behandle det af Europa-Kommissionen rejste problem på grundlag af de foreliggende data.
English: However, in study 4 longer pre-calving periods were investigated.
Danish: I undersøgelse 4 blev der imidlertid undersøgt længere perioder for kælvning.
English: Issues related to availability of veterinary medicines and animal welfare are outside the scope of this referral.
Danish: Spørgsmål vedrørende tilgængeligheden af veterinære lægemidler og dyrevelfærd ligger uden for indbringelsens område.
English: However, it must be emphasised that these data are limited, with very few studies specifically addressing the depletion of residues of relevant substances in dry cattle/sheep/goats.
Danish: Det må imidlertid understreges, at disse data er begrænsede, da meget få undersøgelser specifikt omhandler nedbrydelse af restkoncentrationer af de relevante stoffer i golde køer/får/geder.
English: In view of the limited data available the Committee considered it appropriate to round these minimum time spans upwards in order to arrive at general recommendations.
Danish: På baggrund af de begrænsede foreliggende data anså udvalget det for hensigtsmæssigt at runde disse mindste tidsrum op ved fastsættelse af generelle anbefalinger.
English: It is noted that, in practice, the dry period is generally considerably shorter than 20 weeks.
Danish: Det bemærkes, at goldperioden sædvanligvis i praksis er betydeligt kortere end 20 uger.
English: While the general nature of the recommendations has its limitations, the approach used aims to provide pragmatic use of limited resources.
Danish: Skønt disse anbefalinger har deres begrænsninger som følge af deres generelle art, tilstræbes det med den anvendte fremgangsmåde at udnytte begrænsede ressourcer på en pragmatisk måde.
English: Provet Aspropyrgos 19300, Attik GREECE
Danish: Grækenland Provet Aspropyrgos 19300, Attik GRÆKENLAND
English: La Selva 135 17170 Amer (Gerona) SPAIN
Danish: La Selva 135 17170 Amer (Gerona) SPANIEN
English: It is noted that, in practice, the dry period is generally considerably shorter than 81 days or 12 weeks.
Danish: Det må bemærkes, at goldperioden sædvanligvis i praksis er betydeligt kortere end 81 dage eller 12 uger.
English: D-10785 Berlin GERMANY
Danish: D-10785 Berlin TYSKLAND
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States
Danish: Liste over veterinærlægemidlernes navne, lægemiddelformer, styrker, dyrearter, administrationsveje og ansøgere/indehavere af markedsføringstilladelse i medlemsstaterne
English: Approach taken by CVMP
Danish: CVMP's tilgang
English: Northern Ireland UNITED KINGDOM
Danish: Northern Ireland DET FORENEDE KONGERIGE
English: bw duration equation 2
Danish: bw duration ligning 2
English: 1348 Luvain-la-Neuve BELGIUM
Danish: 1348 Luvain-la-Neuve BELGIEN
English: 40064 Ozzano Emilia (BO) ITALY
Danish: 40064 Ozzano Emilia (BO) ITALIEN
English: Pfizer Holding France 23/25 Avenue du Docteur Lannelongue
Danish: Pfizer Holding Frankrig 23/25 Avenue du Docteur Lannelongue
English: Pfizer Healthcare Ireland 9 Riverwalk
Danish: Pfizer Healthcare Irland 9 Riverwalk
English: The statement ‘do not use during the last trimester of pregnancy' was considered appropriate to overcome uncertainties resulting from the identified deficiencies.
Danish: Udtalelsen “må ikke anvendes i sidste trimester af drægtighedsperioden” blev anset for passende til at imødegå den usikkerhed, der følger af de fundne mangler.
English: It was concluded that residues in pasma would be below 0.18 μg/l 78 days (11 weeks) after administration.
Danish: Det blev konkluderet, at restkoncentrationerne i plasma vil være under 0,18 μg/l 78 dage (11 uger) efter administration.
English: Fasciola hepatica (common name: liver fluke), is the causative agent of fasciolosis, one of the most economically important helminth diseases of livestock worldwide.
Danish: Fasciola hepatica (trivialnavn: leverikte) er årsag til leverikteinfektion (fascioliasis), der er en af verdens økonomisk mest betydningsfulde helmintsygdomme i dyrebesætninger.
English: E-08950 Esplugues de Llobregat (Barselona) SPAIN
Danish: E-08950 Esplugues de Llobregat (Barselona) SPANIEN
English: 4 The SCLR method (CVMP 2000) is intended for use in milk withdrawal period calculations.
Danish: 4 SCLR-metoden (CVMP 2000) er bestemt til beregning af tilbageholdelsestider for mælk.
English: Benefit-Risk Assessment
Danish: Vurdering af risk/benefit-forholdet
English: This analysis used the ‘SCLR' (Safe concentrations based on linear regression) method.
Danish: Denne analyse er udført ved hjælp af SCLR (”Safe concentrations based on linear regression”).
English: Consequently, it is concluded that residues in milk can only be expected to be below 10 µg/l if animals are prevented from grooming other (treated) animals.
Danish: Det kan derfor konkluderes, at restkoncentrationerne i mælk kun kan forventes at være under 10 µg/l, hvis dyrene hindres i at soignere andre (behandlede) dyr.
English: KRKA tovarna zdravil, d.d.
Danish: Slovenien KRKA tovarna zdravil, d.d.
English: D-81379 München GERMANY
Danish: D-81379 München
English: el equation 1
Danish: el ligning 1
English: The marker residue established for tissues is the ‘sum of extractable residues which may be oxidised to ketotriclabendazole'.
Danish: Den fastlagte restmarkør for væv er “summen af ekstraherbare restkoncentrationer, der kan oxideres til ketotriclabendazol”.
English: Not relevant as used in combination products only
Danish: Ikke relevant, da stoffet kun anvendes i kombinationslægemidler
English: Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANCE
Danish: Novartis Santé Animale 14 Boulevard Richelieu 92500 Rueil Malmaison FRANKRIG
English: However, residue levels in milk from the first milkings were in the range of 50 to 730 μg/l.
Danish: Restkoncentrationerne i mælk fra første malkning var imidlertid i området 50-730 μg/l.
English: Flukicidal substances are anthelmintics which are active against parasites belonging to the class of trematodes.
Danish: Trematodemidler er anthelmintika, som er aktive mod parasitter tilhørende klassen trematoder.
English: 5531 AH Bladel THE NETHERLANDS
Danish: 5531 AH Bladel
English: 300 mg/tab Tablets oral
Danish: 300 mg/tab Tabletter oral
English: However, because the type of data are similar the method is also considered appropriate for use here.
Danish: Da der er tale om samme datatype, anses metoden imidlertid for også at være egnet i dette tilfælde.
English: This can be done by using empirically derived milk to plasma ratios or, in principle, by using appropriate pharmacokinetic data (as described by Rasmussen, 19661).
Danish: Dette kan gøres ved anvendelse af empirisk bestemte forhold mellem mælk og plasma eller i princippet ved hjælp af passende farmakokinetiske data (som beskrevet af Rasmussen, 19661).
English: Not possible to determine
Danish: Kan ikke bestemmes
English: Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd.
Danish: Tyskland Bimeda Chemicals Export a Division of Cross Vetpharm Group, Ltd.
English: Based on the considerations above the Committee concluded that a conservative recommendation would be appropriate.
Danish: På grundlag af disse overvejelser konkluderede udvalget, at det vil være hensigtsmæssigt med en restriktiv anbefaling.
English: The Committee therefore calculated minimum time spans that should elapse between administration of these substances and calving or lambing/kidding for each substance, species and route of administration.
Danish: Udvalget behandlede derfor det mindste tidsrum, der bør gå mellem administration af disse stoffer og kælvning eller læmning for hvert stof og for hver dyreart og administrationsvej.
English: AniMedica GmbH Im Südfeld 9
Danish: Tyskland AniMedica GmbH Im Südfeld 9
English: Bury St Edmunds Suffolk IP30 9UP UNITED KINGDOM
Danish: Bury St Edmunds Suffolk IP30 9UP DET FORENEDE KONGERIGE
English: A period of one year is therefore considered to represent a conservative default value that can be used where no substance/route specific data are available.
Danish: Et tidsrum på ét år bør derfor anses for at repræsentere en restriktiv standardværdi, som kan anvendes, når der ikke foreligger specifikke data for stoffet eller administrationsvejen.
English: Nitroxinil was therefore considered to be an appropriate marker residue for use in milk.
Danish: Nitroxinil blev derfor anset for at være en egnet restmarkør for mælk.
English: 8501 Novo Mesto SLOVENIA
Danish: 8501 Novo Mesto
English: S.C. Romvac Company s.a. Şos.
Danish: Rumænien S.C. Romvac Company s.a. Şos.
English: Loughrea, Co. Galway IRELAND
Danish: Loughrea, Co. Galway IRLAND
English: However, as it is common practice to keep animals in a group, there is a risk that concentrations of triclabendazole in milk will exceed 10 μg/l, possibly even in untreated (lactating) animals.
Danish: Da det imidlertid er praksis at holde dyrene i gruppe, der risiko for, at koncentrationerne af triclabendazol i mælk vil være over 10 μg/l selv i ubehandlede (lakterende) dyr.
English: However, these substances are administered during the dry period for the prevention and treatment of trematode infections in dairy animals.
Danish: Disse stoffer administreres imidlertid i goldperioden til forebyggelse og behandling af trematodeinfektioner hos mælkeproducerende dyr.
English: They have been used during the dry period with different precautionary measures including safety spans prior to calving,or lambing/kidding.
Danish: De er blevet anvendt i goldperioden med forskellige forsigtighedsforanstaltninger, herunder en sikkerhedsperiode inden kælvning/læmning.
English: Predicting residue levels in milk based on data in plasma
Danish: Forudsigelse af restkoncentrationer i mælk på grundlag af data for plasma
English: It is also noteworthy that the CVMP recommendation relating to the use of nitroxinil in cattle is meant to be applicable to all nitroxinil containing products including those with different formulations and strengths.
Danish: Derudover bør det påpeges, at CVMP's anbefaling om anvendelse af nitroxinil hos kvæg tiltænkes anvendt på alle lægemidler indeholdende nitroxinil, herunder lægemidler med andre formuleringer og styrker.
English: Available data Study 1.
Danish: Foreliggende data Undersøgelse 1.
English: Table - Safe time spans between treatment and calving or lambing/kidding for five flukicidal substances
Danish: Tabel - sikre intervaller mellem behandling og kælvning eller læmning for fem trematodemidler
English: For the purposes of this referral the time interval of 119 days can be equated to half of the gestation period.
Danish: I denne indbringelse vil tiden 119 dage blive sat til halvdelen af drægtighedsperioden.
English: To calculate the total number of molecules administered the following information is required: the total treatment dose given to the animal; the bodyweight of the animal; the molar weight of the drug substance; and Avogadro's number.
Danish: Følgende oplysninger behøves for at beregne det totale antal administrerede molekyler: Den samlede dosis, der er administreret til dyret, dyrets kropsvægt, lægemiddelstoffets molvægt og Avogadros tal.
English: On 14 February 2011, the European Commission initiated a referral under Article 35 of Directive 2001/82/EC, as amended, for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no MRL has been established in milk intended for use in all ruminants producing milk for human consumption.
Danish: Den 14. februar 2011 indledte Europa-Kommissionen en indbringelsesprocedure i henhold til artikel 35 i direktiv 2001/82/EF, som ændret, for alle veterinærlægemidler indeholdende aktive stoffer tilhørende klassen trematodemidler, for hvilke der ikke er fastsat maksimalgrænseværdier for restkoncentrationer i mælk, og som er bestemt til anvendelse hos alle drøvtyggere, der producerer mælk til menneskeligt konsum.
English: Use of the same marker residue was considered appropriate for milk.
Danish: Det blev anset for hensigtsmæssigt at benytte samme restmarkør til mælk.