FrancophonIA/ELRC3.0 huggingface dataset:
English: The LOQ is equal to 11% of the dose added to manure (0.4/3.6) and the LOD is equal to 2.7% (0.1/3.6) of the dose added to manure.
Danish: Kvantificeringsgrænsen svarer til 11 % af den dosis, der er tilsat gødningen (0,4/3,6), detektionsgrænsen svarer til 2,7 % (0,1/3,6) af den dosis, der er tilsat gødningen.
English: • Commercial veal unit: UK - 75% (Miller et al, 19802).
Danish: • Kommercielle kalveenheder: Det Forenede Kongerige - 75 % (Miller et al, 19802).
English: • Dairy calves: Sweden - 2.2-53.3% (Svensson et al 20064).
Danish: • Mælkekalve: Sverige - 2,2-53,3 % (Svensson et al 20064).
English: In this instance a number of publications were provided to substantiate the proportion of animals treated for BRD within a herd.
Danish: I dette tilfælde blev der forelagt en række publikationer for at dokumentere andelen af dyr, der blev behandlet for bovin luftvejssygdom i en besætning.
English: = Housing factor either 1 for animals housed throughout the year or 0.5 for animals housed for only 6 months (see Table 3 of the guideline) = Conversion factor [1000 μg.mg-1]
Danish: = Bygningsfaktor, enten 1 for dyr, der huses hele året, eller 0,5 for dyr, der huses seks måneder om året (se tabel 3 i retningslinjerne.)
English: This overall process is described in VICH Phase I and Phase II guidelines (VICH Topic GL6 (Ecotoxicity Phase I; Guideline on environmental impact assessment (EIAS) for veterinary medicinal products - Phase I (CVMP/VICH/592/98-FINAL) and VICH GL 38 (Environmental impact assessment for veterinary medicinal products - Phase II (CVMP/VICH/790/03-FINAL)).
Danish: Det samlede forløb er beskrevet i VICH-retningslinjerne for fase I og fase II (VICH Topic GL6 (økotoksicitet fase I, "Guideline on environmental impact assessment (EIAS) for veterinary medicinal products" - fase I (CVMP/VICH/592/98-FINAL)) og VICH GL38 ("Environmental impact assessment for veterinary medicinal products" - fase II (CVMP/VICH/790/03-FINAL))).
English: • Commercial farms (several breeds and age): France - 15.7%, Germany - 20.3%, Italy - 15.2%, Spain - 17.1% (Godinho et al, 20055).
Danish: • Kommercielle gårde (flere racer og aldersklasser): Frankrig - 15,7 %, Tyskland - 20,3 %, Italien15,2 %, Spanien - 17,1 % (Godinho et al, 20055).
English: • Dairy farm calves: Italy - 28.9% (Makoshey et al, 20086).
Danish: • Kalve fra mælkeproducerende gårde: Italien - 28,9 % (Makoshey et al, 20086).
English: The CVMP concluded that adequate evidence had been provided to demonstrate that the proportion of treated animals in a herd would not be higher than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni and that the data justified the use of this figure of 38% as the value for the proportion of treated animals in a herd, for use in calculating the PECsoil.
Danish: CVMP konkluderede, at der var fremlagt tilstrækkelig dokumentation til at vise, at andelen af behandlede dyr i en besætning ikke ville overstige 38 % for terapeutisk behandling af luftvejsinfektioner hos kvæg forårsaget af Mannheimia haemolytica, Pasteurella multocida og Histophilus somni, og at dataene retfærdiggjorde brugen af de 38 % som værdien for andelen af behandlede dyr i en besætning i forbindelse med beregning af PECsoil.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUMÉ OG INDLÆGSSEDDEL
English: • Veal calves: The Netherlands - 19.8%, Belgium - 13.3% (Catry et al, 20091).
Danish: • Slagtekalve: Nederlandene - 19,8 %, Belgien - 13,3 % (Catry et al, 20091).
English: In this case a number of studies were provided to demonstrate that the proportion of treated animals in a herd would not be greater than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Danish: I dette tilfælde blev der fremlagt en række undersøgelser for at vise, at andelen af behandlede dyr i en besætning ikke ville overstige 38 % for terapeutisk behandling af luftvejsinfektioner hos kvæg forårsaget af Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: The Marketing Authorisation Holder provided data with the aim of demonstrating that the percentage of herd animals that will be treated for Bovine Respiratory Disease (BRD) is less than the default value of 50% given in the CVMP guideline mentioned above (EMEA/CVMP/ERA/418282/2005Rev.1).
Danish: Indehaveren af markedsføringstilladelsen fremlagde data med det formål at vise, at den procentvise andel af dyr i en besætning, der vil blive behandlet for bovin luftvejssygdom, er mindre end standardværdien på 50 %, som fremgår af de ovennævnte CVMP-retningslinjer (EMEA/CVMP/ERA/418282/2005-Rev.1).
English: The PECsoil for each cattle type (calves, dairy cows, cattle 0-1 year, cattle over 2 years) has been calculated using 38% as the proportion of the herd treated, according to the following formula (from the CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005-Rev.1).
Danish: PECsoil for hver kvægtype (kalve, malkekøer, kalve fra nul til et år, kalve over to år) er blevet beregnet på grundlag af 38 % som andelen af dyr i besætningen, der bliver behandlet, efter den følgende formel (fra CVMP's "Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38" - EMEA/CVMP/ERA/418282/2005-Rev.1).
English: = Number of days of treatment [d] BW = Animal body weight [kgbw] (see Table 3 of the guideline.)
Danish: BW = Dyrets legemsvægt [kglv] (se tabel 3 i retningslinjerne.)
English: • Beef calves: Spain - 31.5%, UK - 13-15% (Martin et al, 20073).
Danish: • Fedekalve: Spanien - 31,5 %, Det Forenede Kongerige - 13-15 % (Martin et al, 20073).
English: “Diseases caused by florfenicol susceptible bacteria: therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni”.
Danish: "Sygdomme forårsaget af bakterier, der er følsomme over for florfenicol: terapeutisk behandling af luftvejsinfektioner hos kvæg forårsaget af Mannheimia haemolytica, Pasteurella multocida og Histophilus somni".
English: When such specific information is not available then the default values given in Table 2 of the CVMP guideline in support of VICH guidelines (Guideline on Environmental Impact Aassessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 - EMEA/CVMP/ERA/418282/2005Rev.1 - also known as the Technical Guidance Document - TGD) should be used.
Danish: Hvis sådanne specifikke oplysninger ikke er tilgængelige, bør standardværdierne i tabel 2 i CVMP's retningslinjer ("Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38" - EMEA/CVMP/ERA/418282/2005-Rev.1 - også kendt som det teknisk vejledende dokument) anvendes.
English: The product is presented as a solution for injection containing 300 mg of florfenicol per ml solution for injection and it is intended for the therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Danish: Produktet foreligger som injektionsvæske, opløsning, med et indhold af 300 mg florfenicol per ml injektionsvæske, opløsning, og det er beregnet til terapeutisk behandling af luftvejsinfektioner hos kvæg forårsaget af Mannheimia haemolytica, Pasteurella multocida og Histophilus somni.
English: 10000 = Area of 1 hectare [m2 .ha-1]
Danish: = Rumvægten af tør jord [kg.m-3] 10000 = Arealet af en hektar [m2 .ha-1]
English: According to the CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guideline GL6 and GL38 (EMEA/CVMP/ERA/418282/2005Rev.1), complete degradation has to be demonstrated either by total mineralisation or by the presence of degradation products all representing 5% or less of the total dose.
Danish: Ifølge CVMP's "Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38" (EMEA/CVMP/ERA/418282/2005-Rev.1) skal der påvises fuldstændig nedbrydning enten ved total mineralisering eller gennem forekomsten af nedbrydningsprodukter, der alle udgør 5 % eller mindre af den samlede mængde.
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) indicates that the proportion of animals in the herd which is treated may be available from information in the dossier such as field trial data or from the scientific literature.
Danish: CVMP's "Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38" (EMEA/CVMP/ERA/418282/2005-Rev.1) indikerer, at andelen af dyr i besætningen, der bliver behandlet, kan være tilgængelig blandt oplysningerne i dokumentationen, såsom data fra feltundersøgelser, eller fra faglitteraturen.
English: Calf
Danish: Kalv
English: The CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL8 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) provides default values for the proportion of animals in a herd which is treated, for use in the calculation of PECsoil.
Danish: CVMP's "Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL8 and GL38" (EMEA/CVMP/ERA/418282/2005-Rev.1) indeholder standardværdier for den andel af dyr i en besætning, der er behandlet, til brug i beregningen af PECsoil.
English: = Animal turnover rate per place per year [place-1.y-1] (see Table 3 of the guideline) = EU nitrogen spreading limit [kg N.ha-1]
Danish: = Omsætningsrate per sted per år [place-1.y-1] (se tabel 3 i retningslinjerne.)
English: In particular, concerns were raised over the adequacy of the data provided by the Marketing Authorisation Holder on the incidence of bovine respiratory disease (BRD) within an infected herd and as a consequence objections were raised over the proposal to deviate from the default value of 50% specified in CVMP Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) as the value for the proportion of infected animals for use in calculation of the Predicted Environmental Concentration in soil (PECsoil).
Danish: Som følge heraf blev der gjort indsigelser mod forslaget om at afvige fra standardværdien på 50 % som angivet i CVMP's "Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in Support of the VICH Guidelines GL6 and GL38" (EMEA/CVMP/ERA/418282/2005-Rev.1) som værdien for andelen af inficerede dyr til brug i beregningen af PECsoil (PEC-værdier i jord (Predicted Environmental Concentration)).
English: = Fraction of herd treated [value between 0 and 1] (see Table 2 of the guideline) = Bulk density of dry soil [kg.m-3]
Danish: = Del af besætningen, der er behandlet [værdi mellem nul og en] (se tabel 2 i retningslinjerne.)
English: Bristol
Danish: Malkeko
English: 1500 x 10000 x 0.05 x 18 x 0.5 Cattle (> 2 years) PECsoil = 40 x 1 x 450 x 1 x 170 x 0.38 x 1000=
Danish: 1500 x 10000 x 0,05 x 18 x 0,5 Kvæg (> to år) PECsoil = 40 x 1 x 450 x 1 x 170 x 0,38 x 1000=
English: 1500 x 10000 x 0.05 x 10 x 1 Cattle (0 - 1 year) PECsoil = 40 x 1 x 200 x 1 x 170 x 0.38 x 1000 =
Danish: 1500 x 10000 x 0,05 x 10 x 1 Kvæg (nul til et år) PECsoil = 40 x 1 x 200 x 1 x 170 x 0,38 x 1000 =
English: Marixino should be given once a day at the same time every day.
Danish: Marixino skal gives en gang dagligt på samme tidspunkt hver dag.
English: This is a summary of the European public assessment report (EPAR) for Marixino.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Marixino.
English: The full EPAR for Marixino can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Marixino findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 1 Previously known as Maruxa.
Danish: Tidligere kendt som Maruxa.
English: The name of the medicine was changed to Marixino on 9 August 2013.
Danish: Navnet blev ændret til Marixino den 9 august 2013.
English: The company provided data on the medicine's solubility, composition and absorption in the body.
Danish: Virksomheden fremlagde data om lægemidlets opløselighed, sammensætning og optagelse i kroppen.
English: The Committee recommended that Marixino be approved for use in the EU.
Danish: Udvalget anbefalede, at Marixino godkendes til anvendelse i EU.
English: Other information about Marixino
Danish: Andre oplysninger om Marixino
English: ‘Bioequivalent' means that the medicines are expected to produce the same levels of the active substance in the body.
Danish: ”Bioækvivalent” betyder, at de to lægemidler forventes at danne den samme mængde af det aktive stof i kroppen.
English: Marixino is a ‘generic medicine'.
Danish: Marixino er et ”generisk lægemiddel”.
English: What measures are being taken to ensure the safe and effective use of Marixino?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Marixino?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Maruxa on 29 April 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Marixino den 29. april 2013.
English: It contains the active substance memantine hydrochloride.
Danish: Det indeholder det aktive stof memantinhydrochlorid.
English: Marixino is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour.
Danish: Marixino er et lægemiddel til behandling af patienter med moderat til svær Alzheimers sygdom, dvs. en type demens (en hjernesygdom), der gradvis påvirker hukommelse, intellektuelle evner og adfærd.
English: This means that Marixino is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Danish: Det betyder, at Marixino er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Ebixa.
English: What are the benefits and risks of Marixino?
Danish: Hvilke fordele og risici er der forbundet med Marixino?
English: Marixino memantine
Danish: Marixino memantin
English: It is not intended to provide practical advice on how to use Marixino.
Danish: Det er ikke en praktisk vejledning i, hvordan Marixino bør anvendes.
English: The active substance in Marixino, memantine, is an antidementia medicine.
Danish: Det aktive stof i Marixino, memantin, er et lægemiddel mod demens.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Marixino by the patient.
Danish: Behandlingen bør kun iværksættes, hvis en omsorgsgivende person regelmæssigt overvåger patientens indtagelse af Marixino.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Marixino has been shown to have comparable quality and to be bioequivalent to Ebixa.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Marixino er af sammenlignelig kvalitet og er bioækvivalent med Ebixa.
English: What is Marixino and what is it used for?
Danish: Hvad er Marixino, og hvad anvendes det til?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Marixino, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Marixino, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: Marixino is available as 10 mg and 20 mg tablets and can only be obtained with a prescription.
Danish: Memantine fås som tabletter (10 mg og 20 mg) og udleveres kun efter recept.
English: Why is Marixino approved?
Danish: Hvorfor blev Marixino godkendt?
English: Because Marixino is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Marixino er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information about treatment with Marixino, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Marixino, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing
Danish: Tolerance og dosis bør vurderes inden for 3 måneder efter behandlingens start, og herefter bør fordelene ved at fortsætte behandlingen med Marixino regelmæssigt genvurderes.
English: No additional studies in patients were required as Marixino was shown to have comparable quality and is considered to be bioequivalent to the reference medicine, Ebixa.
Danish: Det er ikke nødvendigt med yderligere undersøgelser af patienter, da det er blevet påvist, at Marixino er af sammenlignelig kvalitet og er bioækvivalent med referencelægemidlet Ebixa.
English: To prevent side effects, the dose of Marixino is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Danish: anden uge er den 10 mg, og i den tredje uge er den 15 mg. Fra uge fire og fremover er den anbefalede vedligeholdelsesdosis 20 mg én gang dagligt.
English: For practical information about using Marixino, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Marixino, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Marixino used?
Danish: Hvordan anvendes Marixino?
English: How has Marixino been studied?
Danish: Hvordan blev Marixino undersøgt?
English: How does Marixino work?
Danish: Hvordan virker Marixino?
English: The company requested a re-examination of the opinion.
Danish: Virksomheden har anmodet om en fornyet-overvejelse af udtalelsen.
English: What was the medicine expected to be used for?
Danish: Hvad forventedes lægemidlet anvendt til?
English: How does the medicine work?
Danish: Hvordan virker lægemidlet?
English: At the time of the initial review, the CHMP had a number of concerns.
Danish: På tidspunktet for den oprindelige gennemgang havde CHMP en række betænkeligheder.
English: The company that applied for authorisation is XBiotech Germany GmbH.
Danish: Den virksomhed, der har indgivet ansøgningen, er XBiotech Germany GmbH.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk forsøg eller i et program for anvendelse med særlig udleveringstilladelse og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: During the re-examination, the Committee was reassured that no commonly reported side effects appear to be directly linked to this medicine.
Danish: Under den fornyede gennemgang blev udvalget forsikret om, at ingen af de bivirkninger, der almindeligvis indberettes, synes at være direkte forbundet med lægemidlet.
English: Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials.
Danish: Endelig var der ikke tilstrækkelig kontrol med fremstillingsprocessen, som skulle sikre, at lægemidlet ville have samme kvalitet som det produkt, der var anvendt i de kliniske forsøg.
English: The medicine was compared with placebo (a dummy treatment).
Danish: Lægemidlet blev sammenlignet med en virkningsløs behandling (placebo).
English: The company presented results of a main study in 333 patients looking at the effects of this medicine on lean body mass (body weight excluding fat) and quality of life.
Danish: Virksomheden fremlagde resultater af en hovedundersøgelse hos 333 patienter vedrørende dette lægemiddels virkninger på mager kropsmasse (kropsvægt uden fedt) og livskvalitet.
English: However, insufficient safety data are available to properly assess its overall risks and the committee still had concerns about the medicine's benefits and manufacturing controls.
Danish: Der er dog ingen tilstrækkelige oplysninger tilgængelige, som giver mulighed for grundigt at vurdere dets overordnede risici, og udvalget havde stadig betænkeligheder med hensyn til lægemidlets fordele og kontrollen ved fremstillingen.
English: Such symptoms include cachexia, a form of muscle wasting with significant weight loss.
Danish: Sådanne symptomer omfatter kakeksi, en form for muskelsvind med betydeligt vægttab.
English: growth and spread of cancer cells.
Danish: vækst og spredning.
English: The company informed the CHMP that it will continue to provide the medicine to all patients currently enrolled in clinical trials or compassionate use programmes.
Danish: Virksomheden informerede CHMP om, at den fortsat vil levere lægemidlet til alle patienter, der på nuværende tidspunkt deltager i kliniske forsøg eller programmer for anvendelse med særlig udleveringstilladelse.
English: Firstly, the study did not show clear improvements in either lean body mass or quality of life.
Danish: For det første viste undersøgelsen ikke klare forbedringer i hverken legemsvægt uden kropsfedt eller livskvalitet.
English: The CHMP therefore maintained its opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CHMP fastholdt CHMP, at fordelene ved dette lægemiddel ikke opvejede risiciene, og anbefalede afslag på ansøgning om markedsføringstilladelse.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.
Danish: CHMP gennemgik begrundelsen for anmodningen og foretog en fornyet overvejelse af den oprindelige udtalelse, men bekræftede den 14. september 2017 afslaget på ansøgningen om markedsføringstilladelse.
English: By blocking the actions of human interleukin-1 alpha, the medicine was expected to slow down the growth of the cancer, thus relieving patients' symptoms.
Danish: Ved at blokere virkningerne af humant interleukin-1-alpha forventedes lægemidlet at bremse væksten af kræften og derved lindre patientens symptomer.
English: The medicine was expected to be used for treating debilitating symptoms of advanced colorectal cancer (cancer of the large intestine).
Danish: Lægemidlet forventedes anvendt til behandling af svækkende symptomer på fremskreden kræft i tyktarmen (kolorektal cancer).
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske forsøg eller i programmer for anvendelse med særlig udleveringstilladelse?