FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of Mekinist is 2 mg once a day taken on an empty stomach (at least 1 hour before or 2 hours after a meal) and at around the same time every day.
Danish: Dosis af Mekinist er 2 mg én gang dagligt, der tages på tom mave (mindst 1 time før eller 2 timer efter et måltid) og på ca. samme tidspunkt hver dag.
English: Treatment with Mekinist must be started and supervised by a doctor experienced in the use of cancer medicines.
Danish: Behandling med Mekinist skal iværksættes og overvåges af en læge med erfaring i brug af kræftlægemidler.
English: The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment.
Danish: Virkningen blev hovedsagelig bedømt på procentdelen af patienter, der udviste fuldstændigt eller delvist respons på behandlingen.
English: What measures are being taken to ensure the safe and effective use of Mekinist?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Mekinist?
English: An overview of Mekinist and why it is authorised in the EU
Danish: En oversigt over Mekinist, og hvorfor det er godkendt i EU
English: Mekinist's side effects were considered acceptable and manageable with appropriate measures.
Danish: Bivirkningerne ved Mekinist blev anset for acceptable og for at kunne håndteres med passende foranstaltninger.
English: For more information about using Mekinist, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Mekinist se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Mekinist contains the active substance trametinib.
Danish: Mekinist indeholder det aktive stof trametinib.
English: This was based on a main study involving 322 patients who received either Mekinist or the comparator medicine and which measured how long patients lived until their disease got worse.
Danish: Dette var baseret på et hovedstudie, der omfattede 322 patienter, som fik enten Mekinist eller sammenligningslægemidlet, og hvor det blev målt, hvor længe patienterne levede uden sygdomsforværring.
English: Side effects reported with Mekinist are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Mekinist vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What is Mekinist and what is it used for?
Danish: Hvad er Mekinist, og hvad anvendes det til?
English: Why is Mekinist authorised in the EU?
Danish: Hvorfor blev Mekinist godkendt i EU?
English: What are the risks associated with Mekinist?
Danish: Hvilke risici er der forbundet med Mekinist?
English: In an additional study Mekinist did not show any benefit when given to patients who did not respond to previous treatment with another cancer medicine that blocked BRAF.
Danish: I endnu et studie viste Mekinist ingen fordel, når det blev givet til patienter, der ikke havde haft virkning af tidligere behandling med et andet lægemiddel, som blokerede BRAF.
English: For the full list of side effects and restrictions of Mekinist, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Mekinist fremgår af indlægssedlen.
English: When Mekinist is taken in combination with dabrafenib the most common side effects (which may affect more than 1 in 5 people) are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash.
Danish: Når Mekinist tages i kombination med dabrafenib, er de hyppigste bivirkninger (som optræder hos mere end 1 ud af 5 patienter) feber, træthed, kvalme, kulderystelser, hovedpine, diarré, opkastning, ledsmerter og udslæt.
English: Mekinist has been studied in patients whose cancer had the BRAF V600 mutation.
Danish: Mekinist er undersøgt hos patienter, hvis kræft havde BRAF V600-mutationen.
English: In melanoma and non-small cell lung cancer with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Danish: Ved melanomer og ikkesmåcellet lungekræft med BRAF V600-mutationen ses en unormal form af BRAF-proteinet, der aktiverer et andet protein, MEK, som medvirker til at stimulere celledeling.
English: The European Medicines Agency decided that Mekinist's benefits in cancers that carry the BRAF V600 mutation are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur vurderede, at fordelene ved Mekinist til behandling af kræft med BRAF V600-mutationen opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Mekinist is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) in their genes called 'BRAF V600'.
Danish: Mekinist er et lægemiddel mod kræft, der anvendes til behandling af voksne patienter, hvis kræftceller i deres gener har en specifik mutation (forandring), som kaldes BRAF V600.
English: In one study, 423 patients were given either the combination or dabrafenib alone.
Danish: I det ene studie fik 423 patienter enten kombinationsbehandling eller dabrafenib alene.
English: Mekinist can be continued for as long as the patient benefits from it. After surgery for advanced melanoma, treatment is normally continued for 12 months unless the disease comes back.
Danish: Efter operation for fremskredent melanom fortsættes behandlingen normalt i 12 måneder, medmindre sygdommen vender tilbage.
English: Mekinist was more effective than the cancer medicines dacarbazine or paclitaxel at controlling melanoma that had spread to other parts of the body or could not be removed surgically.
Danish: Mekinist var mere effektivt end kræftlægemidlerne dacarbazin og paclitaxel til at kontrollere melanomer, som havde spredt sig til andre dele af kroppen, eller som ikke kunne fjernes kirurgisk.
English: The most common side effects with Mekinist (which may affect more than 1 in 5 people) are rash, diarrhoea, tiredness, peripheral oedema (swelling, especially of ankles and feet), nausea and acneiform dermatitis (acne-like inflammation of the skin).
Danish: De hyppigste bivirkninger ved Mekinist (som koptræder hos mere end 1 ud af 5 patienter) er udslæt, diarré, træthed, hævelse af især ankler og fødder (perifert ødem), kvalme og aknelignende betændelse i huden (akneiform dermatitis).
English: Two additional studies on melanoma that had spread to other parts of the body or could not be removed surgically looked at using the combination of Mekinist and dabrafenib.
Danish: I to yderligere studier af melanomer, som havde spredt sig til andre dele af kroppen, eller som ikke kunne fjernes ved operation, blev kombinationsbehandling med Mekinist og dabrafenib undersøgt.
English: The active substance in Mekinist, trametinib, works by blocking MEK and by preventing its activation by BRAF, thereby slowing down the growth and spread of the cancer.
Danish: Det aktive stof i Mekinist, trametinib, virker ved at blokere MEK og forhindre det i at blive aktiveret af BRAF.
English: The Agency considered that Mekinist when used alone or in combination with dabrafenib had shown a clinically relevant benefit in patients with non-small cell lung cancer or with melanoma that had spread or could not be removed surgically.
Danish: Agenturet var af den opfattelse, at Mekinist alene eller i kombination med dabrafenib har dokumenteret klinisk relevant effekt hos patienter med ikkesmåcellet lungekræft eller med melanom, der har spredt sig, eller som ikke kan fjernes kirurgisk.
English: The use of Mekinist and dabrafenib led to a response in over 60% of the patients, compared with 23% of patients using dabrafenib alone.
Danish: Over 60 % af patienterne udviste respons ved behandling med Mekinist og dabrafenib, sammenholdt med 23 % af de patienter, der fik dabrafenib alene.
English: In one main study, 171 patients with non-small cell lung cancer received either dabrafenib combined with Mekinist or dabrafenib alone.
Danish: I et hovedstudie fik 171 patienter med ikkesmåcellet lungekræft enten dabrafenib i kombination med Mekinist eller dabrafenib alene.
English: Mekinist is used on its own or in combination with another cancer medicine, dabrafenib;
Danish: Mekinist anvendes alene eller i kombination med et andet kræftlægemiddel (dabrafenib)
English: In a study involving 870 patients with stage III melanoma that had been removed surgically, the combination of Mekinist and dabrafenib given for 1 year was compared with placebo (a dummy treatment).
Danish: I et studie, der omfattede 870 patienter med stadie III-melanom, som var fjernet kirurgisk, blev 1 års kombinationsbehandling med Mekinist og dabrafenib sammenlignet med placebo (en uvirksom behandling).
English: What benefits of Mekinist have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Mekinist?
English: Patients taking Mekinist lived on average for 4.8 months before their disease getting worse, compared with 1.5 months for patients given dacarbazine or paclitaxel.
Danish: De patienter, der blev behandlet med Mekinist, levede i gennemsnit 4,8 måneder uden sygdomsforværring, sammenholdt med 1,5 måned for patienter, der fik dacarbazin eller paclitaxel.
English: In a second study involving 704 patients, Mekinist with dabrafenib was compared with another medicine for melanoma, vemurafenib.
Danish: I et andet studie, som omfattede 704 patienter, blev Mekinist i kombination med dabrafenib sammenlignet med et andet lægemiddel mod melanomer, vemurafenib.
English: Patients given the combination lived for 11 months without their disease worsening compared with 8.8 months for those given dabrafenib alone.
Danish: De patienter, der fik kombinationsbehandling, levede gennemsnitligt i 11 måneder uden sygdomsforværring, sammenholdt med 8,8 måneder for dem, der fik dabrafenib alene.
English: How is Mekinist used?
Danish: Hvordan anvendes Mekinist?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mekinist have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Mekinist.
English: It is used in combination with dabrafenib.
Danish: Mekinist anvendes i kombination med dabrafenib.
English: Patients given the combination lived on average 25.6 months versus 18 months with vemurafenib.
Danish: Patienter, der fik kombinationsbehandling, levede gennemsnitligt i 25,6 måneder, sammenholdt med 18 måneder for de patienter, der fik vemurafenib.
English: How does Mekinist work?
Danish: Hvordan virker Mekinist?
English: • advanced (stage III) melanoma after surgery for it. Mekinist is used in combination with dabrafenib;
Danish: • fremskredent melanom (stadie III) efter kirurgi.
English: Milk: 2.5 days
Danish: Mælk: 2,5 dage
English: Amoxicillin All food producing species
Danish: Amoxicillin Alle levnedsmiddelproducerende arter
English: Or variations of that name as referred to in Annex I
Danish: Eller varianter af dette navn som angivet i bilag I
English: Assessment of new data further to the request for re-consideration by the European Commission
Danish: Vurdering af nye oplysninger i forlængelse af anmodningen om fornyet overvejelse fra Europa-Kommissionen
English: Meat and offal: Cattle: 58 days Pigs: 35 days
Danish: Kød og indmad: Kvæg: 58 dage Svin: 35 dage
English: The CVMP concluded that this was not scientifically justified.
Danish: CVMP konkluderede, at dette ikke var videnskabeligt velbegrundet.
English: Re-examination of the opinion
Danish: Fornyet overvejelse af udtalelsen
English: In addition the analytical method for the determination of the residues was not sufficiently validated.
Danish: Yderligere er analysemetoderne til bestemmelse af restkoncentrationerne ikke tilstrækkeligt valideret.
English: The first injection was given in the muscles of the left side of the neck, the second injection was given 48 hours later in the right side of the neck.
Danish: Den første injektion blev givet i musklerne på venstre side af halsen, den anden blev givet 48 timer senere på højre side af halsen.
English: Marketing Authorisation pending 2 Reference Member State for the Mutual recognition Procedure
Danish: Markedsføringstilladelse under behandling 2 Referencemedlemsstaten for den gensidige anerkendelsesprocedure
English: Assessment of residue depletion studies initially submitted
Danish: Vurdering af de oprindeligt forelagte restkoncentrationsundersøgelser
English: The CVMP concluded that the statistical method could not be used based on the data of the new study provided.
Danish: CVMP konkluderede, at den statistiske metode ikke kan anvendes på grundlag af oplysningerne i den forelagte nye undersøgelse.
English: Whilst the finding of amoxicillin concentrations above the MRL at two time points following the apparent clear result at 14 days could be an artefact, it could equally be argued that it was the results at 14 days that proved unreliable.
Danish: Skønt fundet af amoxicillinkoncentrationer over MRL-værdien til to tidspunkter efter det tilsyneladende klare resultat ved 14 dage kan tænkes at være et artefakt, kunne man lige så godt hævde, at det er resultatet ved 14 dage, der må anses for upålideligt.
English: LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ANIMAL SPECIES, FREQUENCY AND ROUTES OF ADMINISTRATION, RECOMMENDED DOSES, WITHDRAWAL PERIODS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES CONCERNED BY THE REFERRAL
Danish: LISTE OVER NAVNE, LÆGEMIDDELFORMER, STYRKER, DYREARTER, INDGIVELSESVEJ OG -HYPPIGHED, ANBEFALEDE DOSER, TILBAGEHOLDELSESTIDER SAMT INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I DE MEDLEMSSTATER, DER BERØRES AF INDBRINGELSEN
English: However an ADI for penicillins was not established.
Danish: Der blev imidlertid ikke fastsat en ADI-værdi for penicilliner.
English: For pigs of 40-50 kg, it was possible to derive a withdrawal period of 35 days based on injection site residues.
Danish: For svin på 40-50 kg kan der udledes en tilbageholdelsestid på 35 dage på grundlag af restkoncentrationerne på injektionsstedet.
English: Therefore withdrawal periods for cattle and pigs could not be recommended.
Danish: Der kan derfor ikke anbefales tilbageholdelsestider for kvæg eller svin.
English: On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/90, in accordance with the following table:
Danish: På dette grundlag har CVMP foreslået MRL-værdier for amoxicillin og andre penicilliner, og amoxicillin indgår nu bilag I til Rådets forordning (EØF) nr. 2377/90 som angivet i følgende tabel:
English: It was evident that penicillin residues have caused allergic reactions in consumers and that some of these reactions have been serious.
Danish: Det er åbenbart, at penicillinrester har påført forbrugere allergiske reaktioner, som i visse tilfælde har været alvorlige.
English: Being aware of cases of allergic reactions at very low doses, JECFA recommended that the daily intake of benzylpenicillin from food be kept as low as practicable, and in any case below 30 µg parent drug per person.
Danish: På baggrund af kendte tilfælde af allergiske reaktioner ved meget små doser anbefalede JECFA, at den daglige indtagelse af benzylpenicillin med føden holdes så lav som praktisk muligt, og i alle tilfælde under 30 µg moderstof pr. person.
English: Injection volumes ranged from 2.88 to 5.52 ml.
Danish: Injektionsvolumenet var mellem 2,88 og 5,52 ml.
English: At slaughter, the left (first) injection site was taken for local tolerance assessment.
Danish: Ved slagtningen udtoges en prøve fra injektionsstedet fra venstre side (første injektion) til bedømmelse af den lokale tolerance.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSE FOR SUSPENDERING AF MARKEDSFØRINGSTILLADELSERNE
English: - the CVMP assessed the information provided by the Marketing Authorisation Holder in response to the list of questions agreed by the CVMP, the argumentation provided by the Marketing Authorisation Holder in support of the request for the re-examination of the opinion and new residue data made available by the Marketing Authorisation Holder during the re-consideration of the opinion requested by the European Commission;
Danish: - CVMP vurderede de oplysninger, der var fremlagt af indehaveren af markedsføringstilladelsen, som svar på den række spørgsmål, der var stillet af CVMP, den argumentation, der var fremført af indehaveren af markedsføringstilladelsen som støtte for anmodningen om fornyet overvejelse af udtalelsen, og nye restkoncentrationsdata, der er fremlagt af indehaveren af markedsføringstilladelsen under den fornyede overvejelse af udtalelsen, der er foretaget på anmodning fra Europa-Kommissionen
English: In setting maximum residue limits (MRLs) for the penicillins, the CVMP adopted the same approach as the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
Danish: Til fastsættelse af maksimalgrænseværdier for restkoncentrationer (MRL-værdier) for penicillinerne har CVMP benyttet samme fremgangsmåde som Det Fælles FAO/WHO-ekspertudvalg for Tilsætningsstoffer i Levnedsmidler (JECFA).
English: In addition the data were derived from animals weighting approximately 200 kg and receiving only one injection per dose administration, which are not necessarily representative of heavier animals requiring multiple injections.
Danish: Desuden er resultaterne målt på dyr, der vejede ca. 200 kg, og på hvilke hver dosis blev indgivet som kun én injektion, hvilket ikke nødvendigvis er repræsentativt for større dyr, der kræver flere injektioner.
English: Injection volumes ranged from 15.0 to 25.9 ml.
Danish: Injektionsvolumenet var mellem 15,0 og 25,9 ml.
English: GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS
Danish: BEGRUNDELSE FOR SUSPENDERINGEN AF MARKEDSFØRINGSTILLADELSERNE
English: The CVMP set MRLs such that consumer intake from all foods would not exceed this 30 µg threshold.
Danish: CVMP har fastsat MRL-værdierne således, at forbrugerens samlede indtagelse med føden ikke vil overskride denne grænse på 30 µg.
English: 15 mg amoxicillin/kg bw (equivalent to 1ml/10 kg)
Danish: 15 mg amoxicillin/kg legemsvægt (svarende til 1 ml/10 kg)
English: Considering that the study was GLP-compliant, the CVMP cannot lightly dismiss the results in question, especially as there were a total of three ‘positive' samples found.
Danish: I betragtning af, at undersøgelsen var i overensstemmelse med GLP, kan CVMP ikke uden videre afvise de pågældende resultater, specielt eftersom der blev fundet i alt tre "positive" prøver.
English: Amoxicillin was previously evaluated by the CVMP together with other penicillins, in order to establish maximum residue limits (MRLs).
Danish: Amoxicillin var tidligere sammen med andre penicilliner blevet vurderet af CVMP med henblik på at fastsætte maksimalgrænseværdier for restkoncentrationer (MRL-værdier).
English: Whereas: - the CVMP considered the referral made under Article 35 of Directive 2001/82/EC in the interest of the Community regarding consumer safety for national marketing authorisations for Suramox 15% LA or variations of that name as referred to in Annex I;
Danish: Ud fra følgende betragtninger: - CVMP behandlede indbringelsen i henhold til artikel 35, stk. 1, i direktiv 2001/82/EF, med henblik på Fællesskabets interesse i beskyttelse af forbrugerne gennem de nationale markedsføringstilladelser for Suramox 15% LA og varianter af dette navn som anført i bilag I
English: Several cases of allergic reactions in humans following the ingestion of food containing penicillin residues were reviewed.
Danish: Der blev her gennemgået en række tilfælde, hvor der var forekommet allergiske reaktioner hos mennesker efter indtagelse af fødevarer indeholdende penicillinrester.
English: The MAH further argued that the method used was probably not robust enough and cited a recent publication that mentions the need for deproteinization steps to improve method recovery.
Danish: Indehaveren af markedsføringstilladelsen fremførte endvidere, at den anvendte metode antagelig ikke var tilstrækkelig robust, og citerede en nylig publikation, hvori det nævnes, at det er nødvendigt at indføre deproteiniseringstrin for at forbedre metodens genfindingsgrad.
English: Establishment of the withdrawal period following consideration of all residue studies for pigs and cattle available
Danish: Fastsættelse af tilbageholdelsestiden efter hensyntagen til alle foreliggende restkoncentrationsundersøgelser for svin og kvæg
English: Benzylpenicillin was considered by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at its 36th meeting in 1990.
Danish: Benzylpenicillin blev behandlet af Det Fælles FAO/WHOekspertudvalg for Tilsætningsstoffer i Levnedsmidler (JECFA) på dettes 36.
English: - the CVMP, having considered the data provided concluded that the currently established withdrawal periods for cattle and pigs are inadequate to ensure that foodstuffs obtained from the treated animals do not contain residues which might constitute a health hazard to the consumer;
Danish: - CVMP konkluderede efter at have gennemgået de fremlagte oplysninger, at de aktuelt godkendte tilbageholdelsestider for kvæg og svin er utilstrækkelige til at sikre, at levnedsmidler hidrørende fra behandlede dyr ikke indeholder restkoncentrationer af lægemidler, som kan frembyde sundhedsfare for forbrugeren,
English: Only residues at the injection sites were investigated.
Danish: Kun injektionsstederne blev undersøgt for restkoncentrationer.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SURAMOX 15% LA3
Danish: FAGLIGE KONKLUSIONER SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF SURAMOX 15% LA3
English: As the validation data fell within accepted specifications, the CVMP could not agree that it was appropriate to simply dismiss the findings above the MRL as artefacts.
Danish: Da valideringsresultaterne faldt inden for de accepterede specifikationer, kunne CVMP ikke tilslutte sig, at det var hensigtsmæssigt blot at kassere resultater, der lå over MRL-værdierne, som artefakter.
English: 2.1 Calculation of withdrawal periods for Suramox 15% LA
Danish: 2.1 Beregning af tilbageholdelsestider for Suramox 15% LA
English: In the detailed grounds for the re-examination of the opinion the MAH argued that the three out of eight kidney samples with amoxicillin concentrations higher than the MRL at 21 and 27 days after the last administration should be considered artefacts because of the abnormal kinetic depletion residue profile.
Danish: I sin nærmere begrundelse for anmodningen om fornyet overvejelse fremførte indehaveren af markedsføringstilladelsen, at resultaterne for tre ud af otte prøver af nyrevæv med koncentrationer af amoxicillin over MRL-værdien 21 og 27 dage efter sidste administration burde anses for artefakter på grund af den abnorme kinetiske depletionsprofil for restkoncentrationer.
English: the CVMP recommends the suspension of the marketing authorisations for Suramox 15% LA or variations of that name as referred in Annex I, presented as injectable suspension for pigs and cattle.
Danish: anbefaler CVMP suspendering af markedsføringstilladelsen for Suramox 15 % LA og de i bilag I omhandlede varianter af dette navn, der leveres som injektionsvæske, suspension, til svin og kvæg.
English: In a complementary study, eight pigs were slaughtered at 30 and 36 days after treatment with Suramox.
Danish: I en supplerende undersøgelse blev otte svin slagtet 30 og 36 dage efter behandling med Suramox.
English: Reports of further cases, which were not available to JECFA, had also been reported in the published literature.
Danish: I litteraturen er beskrevet andre tilfælde, der ikke har været tilgængelige for JECFA.