FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/575/055 280 film-coated tablets
Danish: EU/1/09/576/055 280 filmovertrukne tabletter
English: EU/1/09/575/003 30 film-coated tablets
Danish: EU/1/09/576/003 30 filmovertrukne tabletter
English: EU/1/09/575/019 280 film-coated tablets
Danish: EU/1/09/576/019 280 filmovertrukne tabletter
English: EU/1/09/575/018 98 film-coated tablets
Danish: EU/1/09/576/018 98 filmovertrukne tabletter
English: EU/1/09/575/054 98 film-coated tablets
Danish: EU/1/09/576/054 98 filmovertrukne tabletter
English: EU/1/09/575/052 56 film-coated tablets
Danish: EU/1/09/576/052 56 filmovertrukne tabletter
English: EU/1/09/575/040 56 film-coated tablets
Danish: EU/1/09/576/040 56 filmovertrukne tabletter
English: EU/1/09/575/030 98 film-coated tablets
Danish: EU/1/09/576/030 98 filmovertrukne tabletter
English: EU/1/09/575/049 14 film-coated tablets
Danish: EU/1/09/576/049 14 filmovertrukne tabletter
English: EU/1/09/575/025 14 film-coated tablets
Danish: EU/1/09/576/025 14 filmovertrukne tabletter
English: EU/1/09/575/041 90 film-coated tablets
Danish: EU/1/09/576/041 90 filmovertrukne tabletter
English: EU/1/09/575/016 56 film-coated tablets
Danish: EU/1/09/576/016 56 filmovertrukne tabletter
English: Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Copalia HCT 10 mg/320 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: EU/1/09/575/053 90 film-coated tablets
Danish: EU/1/09/576/053 90 filmovertrukne tabletter
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Danish: Copalia HCT 10 mg/160 mg/25 mg filmovertrukne tabletter er brun-gule, ovale tabletter præget med ”NVR” på den ene side og ”VHL” på den anden side.
English: EU/1/09/575/051 30 film-coated tablets
Danish: EU/1/09/576/051 30 filmovertrukne tabletter
English: If you think you may be allergic, do not take Copalia HCT and talk to your doctor.
Danish: Hvis du tror, du er overfølsom, skal du tale med din læge, inden du tager Copalia HCT.
English: EU/1/09/575/029 90 film-coated tablets
Danish: EU/1/09/576/029 90 filmovertrukne tabletter
English: EU/1/09/575/002 28 film-coated tablets
Danish: EU/1/09/576/002 28 filmovertrukne tabletter
English: EU/1/09/575/038 28 film-coated tablets
Danish: EU/1/09/576/038 28 filmovertrukne tabletter
English: EU/1/09/575/027 30 film-coated tablets
Danish: EU/1/09/576/027 30 filmovertrukne tabletter
English: EU/1/09/575/039 30 film-coated tablets
Danish: EU/1/09/576/039 30 filmovertrukne tabletter
English: EU/1/09/575/037 14 film-coated tablets
Danish: EU/1/09/576/037 14 filmovertrukne tabletter
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan, and 25 mg hydrochlorothiazide.
Danish: Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 320 mg valsartan og 25 mg hydrochlorthiazid.
English: EU/1/09/575/026 28 film-coated tablets
Danish: EU/1/09/576/026 28 filmovertrukne tabletter
English: EU/1/09/575/028 56 film-coated tablets
Danish: EU/1/09/576/028 56 filmovertrukne tabletter
English: What Copalia HCT is and what it is used for What you need to know before you take Copalia HCT How to take Copalia HCT
Danish: Det skal du vide, før du begynder at tage Copalia HCT Sådan skal du tage Copalia HCT Bivirkninger
English: EU/1/09/575/013 14 film-coated tablets
Danish: EU/1/09/576/013 14 filmovertrukne tabletter
English: EU/1/09/575/017 90 film-coated tablets
Danish: EU/1/09/576/017 90 filmovertrukne tabletter
English: EU/1/09/575/044 56 x 1 film-coated tablet (unit dose) EU/1/09/575/045 98 x 1 film-coated tablet (unit dose) EU/1/09/575/046 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/576/044 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/045 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/046 280 x 1 filmovertrukket tablet (enhedsdosis)
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Copalia HCT 5 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: EU/1/09/575/014 28 film-coated tablets
Danish: EU/1/09/576/014 28 filmovertrukne tabletter
English: EU/1/09/575/056 56 x 1 film-coated tablet (unit dose) EU/1/09/575/057 98 x 1 film-coated tablet (unit dose) EU/1/09/575/058 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/576/056 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/057 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/058 280 x 1 filmovertrukket tablet (enhedsdosis)
English: EU/1/09/575/015 30 film-coated tablets
Danish: EU/1/09/576/015 30 filmovertrukne tabletter
English: EU/1/09/575/050 28 film-coated tablets
Danish: EU/1/09/576/050 28 filmovertrukne tabletter
English: EU/1/09/575/032 56 x 1 film-coated tablet (unit dose) EU/1/09/575/033 98 x 1 film-coated tablet (unit dose) EU/1/09/575/034 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/576/032 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/033 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/034 280 x 1 filmovertrukket tablet (enhedsdosis)
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Copalia HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: EU/1/09/575/008 56 x 1 film-coated tablet (unit dose) EU/1/09/575/009 98 x 1 film-coated tablet (unit dose) EU/1/09/575/010 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/576/008 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/009 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/010 280 x 1 filmovertrukket tablet (enhedsdosis)
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Danish: Copalia HCT 10 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid.
English: Copalia HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Copalia HCT 5 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Copalia HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Danish: Copalia HCT 10 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: EU/1/09/575/020 56 x 1 film-coated tablet (unit dose) EU/1/09/575/021 98 x 1 film-coated tablet (unit dose) EU/1/09/575/022 280 x 1 film-coated tablet (unit dose)
Danish: EU/1/09/576/020 56 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/021 98 x 1 filmovertrukket tablet (enhedsdosis) EU/1/09/576/022 280 x 1 filmovertrukket tablet (enhedsdosis)
English: Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Danish: Copalia HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Danish: Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid
English: EU/1/09/575/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/576/036 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/576/035 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: What Copalia HCT looks like and contents of the pack Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Danish: Copalia HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter er hvide, ovale tabletter præget med ”NVR” på den ene side og ”VCL” på den anden side.
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide.
Danish: Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 25 mg hydrochlorthiazid.
English: EU/1/09/575/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/576/060 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/576/059 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: Due to the hydrochlorothiazide component, Copalia HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
Danish: 4.3) og til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) <30 ml/min/1,73 m2) (se pkt.
English: EU/1/09/575/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/576/012 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/576/011 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
Danish: Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 12,5 mg hydrochlorthiazid.
English: EU/1/09/575/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/576/048 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/576/047 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: EU/1/09/575/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Danish: EU/1/09/576/024 280 filmovertrukne tabletter (mulitpakning, 20 kartoner af 14 tabletter) EU/1/09/576/023 280 filmovertrukne tabletter (multipakning, 4 kartoner af 70 tabletter)
English: (haemolytic anaemia)
Danish: (enhedsdosis)
English: It is available as capsules (150 mg).
Danish: Det findes som kapsler (150 mg).
English: The recommended dose is one capsule once a day.
Danish: Den anbefalede dosis er én kapsel én gang dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Erivedge on 12 July 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Erivedge den 12. juli 2013.
English: This is a summary of the European public assessment report (EPAR) for Erivedge.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Erivedge.
English: The full EPAR for Erivedge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Erivedge findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The patients were given Erivedge until their disease got worse or they could no longer tolerate treatment or withdrew from the study.
Danish: Patienterne fik Erivedge, indtil deres sygdom blev værre, eller de ikke længere kunne tåle behandling eller trak sig fra undersøgelsen.
English: Erivedge was not compared with another treatment.
Danish: Erivedge blev ikke sammenlignet med anden behandling.
English: Other information about Erivedge
Danish: Andre oplysninger om Erivedge
English: Around 33% (11 out of 33) of patients with metastatic disease and 48% (30 out of 63) of patients with locally advanced disease responded to treatment.
Danish: Cirka 33 % (11 ud af 33) af patienter med metastatisk sygdom og 48 % (30 ud af 63) af patienter med lokalt fremskreden sygdom reagerede på behandling.
English: The benefits of continuing treatment should be regularly assessed and the best duration of treatment will vary based on the benefit and side effects experienced by each patient.
Danish: Fordelene ved fortsat behandling skal vurderes regelmæssigt, og den bedste behandlingslængde vil variere på grundlag af de fordele og de bivirkninger, som den enkelte patient oplever.
English: It also considered that the side effects were manageable.
Danish: Det fandt også, at bivirkningerne var overskuelige.
English: What is Erivedge and what is it used for?
Danish: Hvad er Erivedge, og hvad anvendes det til?
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Danish: Eftersom virksomheden har forelagt den nødvendige yderligere dokumentation, er markedsføringstilladelsen blevet ændret fra en betinget godkendelse til en fuldstændig godkendelse.
English: The Committee considered that the benefits of Erivedge had been shown for patients with locally advanced and metastatic disease.
Danish: Udvalget fandt, at fordelene ved Erivedge var blevet påvist for patienter med lokalt fremskreden og metastatisk sygdom.
English: The main measure of effectiveness was the response to treatment, based on reduction by at least 30% in tumour size or disappearance of all signs of cancer (the objective response rate).
Danish: Hovedmålet for effektivitet var responsen på behandling på grundlag af en reduktion i tumorstørrelse på mindst 30 % eller forsvinden af alle tegn på kræft (den objektive responsrate).
English: Erivedge is a cancer medicine that contains the active substance vismodegib.
Danish: Erivedge er et kræftlægemiddel, der indeholder det aktive stof vismodegib.
English: Why is Erivedge approved?
Danish: Hvorfor blev Erivedge godkendt?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Erivedge's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Erivedge opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Erivedge?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Erivedge?
English: Erivedge was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Danish: Erivedge blev oprindeligt tildelt en ”betinget godkendelse”, da virksomheden skulle fremlægge yderligere dokumentation om lægemidlet.
English: It is used to treat adults with basal cell carcinoma (a slow-growing form of skin cancer) in advanced stages: when the cancer is metastatic (has spread to other parts of the body) and is causing symptoms, or when it is locally advanced (has started to spread to nearby areas) and is not suitable for surgery or radiotherapy (treatment with radiation).
Danish: Det anvendes til behandling af voksne med basalcelle-carcinom (en langsomtvoksende form for hudkræft) i fremskredne stadier: Når kræften er metastatisk (har spredt sig til andre dele af kroppen) og giver symptomer, eller når den er lokalt fremskreden (er begyndt at sprede sig til nærtliggende områder) og ikke er egnet til operation eller radioterapi (strålebehandling).
English: Erivedge was studied in one main study involving 104 patients with either metastatic or locally advanced basal cell carcinoma.
Danish: Erivedge blev undersøgt i en hovedundersøgelse, der involverede 104 patienter med enten metastatisk eller lokalt fremskreden basalcelle-carcinom.
English: It is not intended to provide practical advice on how to use Erivedge.
Danish: Det er ikke en praktisk vejledning i, hvordan Erivedge skal anvendes.
English: Erivedge can only be obtained with a prescription.
Danish: Erivedge udleveres kun efter recept.
English: Erivedge must not be used in women who are pregnant or breast-feeding, or who could potentially have children and do not comply with the special pregnancy prevention programme for Erivedge.
Danish: Erivedge må ikke anvendes til kvinder, som er gravide eller ammer, eller som potentielt kan blive gravide og ikke overholder det særlige graviditetspræventionsprogram for Erivedge.
English: The company will report any pregnancies that occur during treatment with Erivedge and will monitor their outcome.
Danish: Virksomheden skal indberette enhver graviditet, der måtte indtræffe under behandling med Erivedge, og overvåge udfaldet.
English: Since Erivedge disrupts the mechanism involved in the early development stages of unborn babies, the CHMP concluded that appropriate measures were needed for both men and women treated with Erivedge to prevent pregnancy during and after stopping treatment.
Danish: Da Erivedge afbryder den mekanisme, der er involveret i ufødte børns tidlige udviklingstrin, besluttede CHMP, at passende foranstaltninger var nødvendige for både mænd og kvinder, der behandles med Erivedge, for at forebygge graviditet under behandlingen og efter dennes afslutning.
English: It should only be prescribed by or under the supervision of a specialist doctor experienced in managing basal cell carcinoma.
Danish: Det må kun ordineres af eller under opsyn af en speciallæge med erfaring i håndtering af basalcelle-carcinom.
English: The company will implement a pregnancy prevention programme, by providing educational materials on the risks to the unborn baby, including a reminder card, to patients and healthcare professionals who prescribe and dispense Erivedge.
Danish: Virksomheden skal implementere et graviditetspræventionsprogram ved at tilvejebringe uddannelsesmaterialer om risiciene for det ufødte barn, herunder en huskeseddel, til patienter og specialuddannet sundhedspersonale, der ordinerer og udleverer Erivedge.
English: The active substance in Erivedge, vismodegib, disrupts the so-called ‘Hedgehog signalling pathway', which is normally involved in regulating the early stages of cell development in unborn babies and certain cell processes in adults.
Danish: Det aktive stof i Erivedge, vismodegib, afbryder den såkaldte 'hegdehog-signaleringsvej', der normalt er involveret i regulering af de tidlige celleudviklingsstadier hos ufødte børn og visse celleprocesser hos voksne.
English: Vismodegib attaches to a protein called ‘SMO', which is involved in activating the Hedgehog signalling pathway.
Danish: Vismodegib knytter sig til et protein, der kaldes SMO, som er involveret i aktivering af hedgehog-signaleringsvejen.
English: For more information about treatment with Erivedge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Erivedge, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What are the risks associated with Erivedge?
Danish: Hvilke risici er der forbundet med Erivedge?
English: It must not be used together with St John's wort (a herbal medicine used to treat depression).
Danish: Det må ikke anvendes sammen med prikbladet perikon (urtemedicin, der anvendes mod depression).
English: The most common side effects with Erivedge (seen in more than 3 in 10 people) are muscle spasms, hair loss, taste disturbances, weight loss, tiredness, nausea (feeling sick) and diarrhoea.
Danish: De hyppigste bivirkninger ved Erivedge (som kan forekomme hos flere end 3 ud af 10 patienter) er muskelspasmer, hårtab, smagsforstyrrelser, vægttab, træthed, kvalme og diarré Den fuldstændige liste over indberettede bivirkninger ved Erivedge fremgår af indlægssedlen.
English: In basal cell carcinoma, the Hedgehog signalling pathway becomes abnormally active and leads to the growth and spread of the cancerous cells.
Danish: I tilfælde af basalcelle-carcinom bliver hedgehog-signaleringsvejen abnormt aktiv, hvilket fører til vækst og spredning af kræftcellerne.
English: By attaching to SMO, vismodegib blocks this pathway, thereby slowing down the growth and spread of the cancer cells in basal cell carcinoma.
Danish: Ved at knytte sig til SMO blokerer vismodegib denne vej og bremser derved vækst og spredning af kræftcellerne i tilfælde af basalcelle-carcinom.
English: For practical information about using Erivedge, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Erivedge, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Erivedge used?
Danish: Hvordan anvendes Erivedge?
English: What benefits of Erivedge have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Erivedge?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Erivedge 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 Erivedge.
English: How does Erivedge work?
Danish: Hvordan virker Erivedge?
English: Milk: 7 days.
Danish: Mælk: 7 dage.
English: The mean half-life calculated is 20.41 days.
Danish: Den beregnede gennemsnitlige halveringstid er 20,41 dage.
English: Meat and offal: as recommended in the relevant sections of Annex III above.
Danish: Kød og indmad: som anbefalet i de pågældende afsnit af bilag III ovenfor.
English: It is normally used as the sulfate salt.
Danish: Normalt anvendes det i form af sulfatsaltet.
English: This is not a standard approach and is not referred to in CVMP guidance.
Danish: Dette er ikke en standardtilgang og omtales ikke i CVMP's vejledning.
English: In that case an extrapolated withdrawal period of 228 days is recommended.
Danish: I dette tilfælde anbefales en ekstrapoleret tilbageholdelsestid på 228 dage.
English: The study design is in accordance with current standards.
Danish: Undersøgelsens design er i overensstemmelse med gældende normer.
English: Applicant/Marketing Authorisation Holder
Danish: Ansøger/indehaver af markedsføringstilladelse
English: The microbiological assay was adequately validated.
Danish: Det mikrobiologiske assay var fyldestgørende valideret.
English: General considerations
Danish: Generelle betragtninger
English: Only two animals per slaughter point were involved.
Danish: Der indgik kun to dyr pr. slagtetidspunkt.
English: This withdrawal period includes a wide safety margin with regard to the available data.
Danish: Denne tilbageholdelsestid giver en bred sikkerhedsmargen i forhold til de foreliggende data.
English: It should be emphasised that the extrapolation method used is a pragmatic approach aimed at preserving product availability while in the same time ensuring consumer safety.
Danish: Det må understreges, at den anvendte metode til ekstrapolation er en pragmatisk tilgang med det formål at opretholde tilgængeligheden af produktet og samtidig varetage forbrugernes sikkerhed.
English: No stability data were presented.
Danish: Der er ikke forelagt stabilitetsdata.
English: The GLP status of the study is not known.
Danish: Undersøgelsens GLP-status kendes ikke.
English: Repeated injections should be made at different injection sites.
Danish: Ved gentagne injektioner bør anvendes forskellige injektionssteder.
English: The studies were either not GLP-compliant, or the status is unknown.
Danish: Undersøgelserne var enten ikke GLP-overensstemmende, eller deres status ukendt.