natgillin/translations-raw huggingface dataset:
EU/1/09/576/004 56 filmovertrukne tabletter 
EU/1/09/575/004 56 film-coated tablets
EU/1/09/576/042 98 filmovertrukne tabletter 
EU/1/09/575/042 98 film-coated tablets
Copalia HCT 10 mg/160 mg/25 mg filmovertrukne tabletter 
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets
EU/1/09/576/001 14 filmovertrukne tabletter 
EU/1/09/575/001 14 film-coated tablets
EU/1/09/576/006 98 filmovertrukne tabletter 
EU/1/09/575/006 98 film-coated tablets
EU/1/09/576/043 280 filmovertrukne tabletter 
EU/1/09/575/043 280 film-coated tablets
Copalia HCT 5 mg/160 mg/25 mg filmovertrukne tabletter 
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets
Copalia HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter 
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets
Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter 
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets
Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter er svagt gule, ovale tabletter præget med ”NVR” på den ene side og ”VDL” på den anden side. 
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Copalia HCT 10 mg/320 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid. 
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
EU/1/09/576/031 280 filmovertrukne tabletter 
EU/1/09/575/031 280 film-coated tablets
EU/1/09/576/005 90 filmovertrukne tabletter 
EU/1/09/575/005 90 film-coated tablets
Der kan opstå symptomatisk hypotension efter indledning af behandling med Copalia HCT hos patienter med væske- og/eller natriummangel, som fx patienter, der får høje doser diuretika. 
In sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur after initiation of treatment with Copalia HCT.
EU/1/09/576/055 280 filmovertrukne tabletter 
EU/1/09/575/055 280 film-coated tablets
EU/1/09/576/003 30 filmovertrukne tabletter 
EU/1/09/575/003 30 film-coated tablets
EU/1/09/576/019 280 filmovertrukne tabletter 
EU/1/09/575/019 280 film-coated tablets
EU/1/09/576/018 98 filmovertrukne tabletter 
EU/1/09/575/018 98 film-coated tablets
EU/1/09/576/054 98 filmovertrukne tabletter 
EU/1/09/575/054 98 film-coated tablets
EU/1/09/576/052 56 filmovertrukne tabletter 
EU/1/09/575/052 56 film-coated tablets
EU/1/09/576/040 56 filmovertrukne tabletter 
EU/1/09/575/040 56 film-coated tablets
EU/1/09/576/030 98 filmovertrukne tabletter 
EU/1/09/575/030 98 film-coated tablets
EU/1/09/576/049 14 filmovertrukne tabletter 
EU/1/09/575/049 14 film-coated tablets
EU/1/09/576/025 14 filmovertrukne tabletter 
EU/1/09/575/025 14 film-coated tablets
EU/1/09/576/041 90 filmovertrukne tabletter 
EU/1/09/575/041 90 film-coated tablets
EU/1/09/576/016 56 filmovertrukne tabletter 
EU/1/09/575/016 56 film-coated tablets
Copalia HCT 10 mg/320 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid 
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
EU/1/09/576/053 90 filmovertrukne tabletter 
EU/1/09/575/053 90 film-coated tablets
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. 
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.
EU/1/09/576/051 30 filmovertrukne tabletter 
EU/1/09/575/051 30 film-coated tablets
Hvis du tror, du er overfølsom, skal du tale med din læge, inden du tager Copalia HCT. 
If you think you may be allergic, do not take Copalia HCT and talk to your doctor.
EU/1/09/576/029 90 filmovertrukne tabletter 
EU/1/09/575/029 90 film-coated tablets
EU/1/09/576/002 28 filmovertrukne tabletter 
EU/1/09/575/002 28 film-coated tablets
EU/1/09/576/038 28 filmovertrukne tabletter 
EU/1/09/575/038 28 film-coated tablets
EU/1/09/576/027 30 filmovertrukne tabletter 
EU/1/09/575/027 30 film-coated tablets
EU/1/09/576/039 30 filmovertrukne tabletter 
EU/1/09/575/039 30 film-coated tablets
EU/1/09/576/037 14 filmovertrukne tabletter 
EU/1/09/575/037 14 film-coated tablets
Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 320 mg valsartan og 25 mg hydrochlorthiazid. 
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan, and 25 mg hydrochlorothiazide.
EU/1/09/576/026 28 filmovertrukne tabletter 
EU/1/09/575/026 28 film-coated tablets
EU/1/09/576/028 56 filmovertrukne tabletter 
EU/1/09/575/028 56 film-coated tablets
Det skal du vide, før du begynder at tage Copalia HCT Sådan skal du tage Copalia HCT Bivirkninger 
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
EU/1/09/576/013 14 filmovertrukne tabletter 
EU/1/09/575/013 14 film-coated tablets
EU/1/09/576/017 90 filmovertrukne tabletter 
EU/1/09/575/017 90 film-coated tablets
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) 
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)
Copalia HCT 5 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid. 
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.
EU/1/09/576/014 28 filmovertrukne tabletter 
EU/1/09/575/014 28 film-coated tablets
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) 
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)
EU/1/09/576/015 30 filmovertrukne tabletter 
EU/1/09/575/015 30 film-coated tablets
EU/1/09/576/050 28 filmovertrukne tabletter 
EU/1/09/575/050 28 film-coated tablets
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) 
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)
Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid. 
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.
Copalia HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid. 
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.
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) 
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)
Copalia HCT 10 mg/160 mg/25 mg filmovertrukne tabletter Aktive stoffer: amlodipin (som amlodipinbesylat), valsartan og hydrochlorthiazid. 
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.
Copalia HCT 5 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid 
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
Copalia HCT 10 mg/160 mg/25 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid 
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide
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) 
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)
Copalia HCT 5 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid 
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Copalia HCT 10 mg/160 mg/12,5 mg filmovertrukne tabletter amlodipin/valsartan/hydrochlorthiazid 
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
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) 
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)
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. 
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.
Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 25 mg hydrochlorthiazid. 
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide.
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) 
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)
4.3) og til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) <30 ml/min/1,73 m2) (se pkt. 
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).
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) 
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)
Hver filmovertrukket tablet indeholder 10 mg amlodipin (som amlodipinbesylat), 160 mg valsartan og 12,5 mg hydrochlorthiazid. 
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
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) 
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)
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) 
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)
(enhedsdosis) 
(haemolytic anaemia)
Det findes som kapsler (150 mg). 
It is available as capsules (150 mg).
Den anbefalede dosis er én kapsel én gang dagligt. 
The recommended dose is one capsule once a day.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Erivedge den 12. juli 2013. 
The European Commission granted a marketing authorisation valid throughout the European Union for Erivedge on 12 July 2013.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Erivedge. 
This is a summary of the European public assessment report (EPAR) for Erivedge.
Den fuldstændige EPAR for Erivedge findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Erivedge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Patienterne fik Erivedge, indtil deres sygdom blev værre, eller de ikke længere kunne tåle behandling eller trak sig fra undersøgelsen. 
The patients were given Erivedge until their disease got worse or they could no longer tolerate treatment or withdrew from the study.
Erivedge blev ikke sammenlignet med anden behandling. 
Erivedge was not compared with another treatment.
Andre oplysninger om Erivedge 
Other information about Erivedge
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. 
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.
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. 
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.
Det fandt også, at bivirkningerne var overskuelige. 
It also considered that the side effects were manageable.
Hvad er Erivedge, og hvad anvendes det til? 
What is Erivedge and what is it used for?
Eftersom virksomheden har forelagt den nødvendige yderligere dokumentation, er markedsføringstilladelsen blevet ændret fra en betinget godkendelse til en fuldstændig godkendelse. 
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Udvalget fandt, at fordelene ved Erivedge var blevet påvist for patienter med lokalt fremskreden og metastatisk sygdom. 
The Committee considered that the benefits of Erivedge had been shown for patients with locally advanced and metastatic disease.
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). 
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).
Erivedge er et kræftlægemiddel, der indeholder det aktive stof vismodegib. 
Erivedge is a cancer medicine that contains the active substance vismodegib.
Hvorfor blev Erivedge godkendt? 
Why is Erivedge approved?
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Erivedge opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
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.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Erivedge? 
What measures are being taken to ensure the safe and effective use of Erivedge?
Erivedge blev oprindeligt tildelt en ”betinget godkendelse”, da virksomheden skulle fremlægge yderligere dokumentation om lægemidlet. 
Erivedge was originally given ‘conditional approval' because there was more evidence to come about the medicine.
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). 
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).
Erivedge blev undersøgt i en hovedundersøgelse, der involverede 104 patienter med enten metastatisk eller lokalt fremskreden basalcelle-carcinom. 
Erivedge was studied in one main study involving 104 patients with either metastatic or locally advanced basal cell carcinoma.
Det er ikke en praktisk vejledning i, hvordan Erivedge skal anvendes. 
It is not intended to provide practical advice on how to use Erivedge.
Erivedge udleveres kun efter recept. 
Erivedge can only be obtained with a prescription.
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. 
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.
Virksomheden skal indberette enhver graviditet, der måtte indtræffe under behandling med Erivedge, og overvåge udfaldet. 
The company will report any pregnancies that occur during treatment with Erivedge and will monitor their outcome.
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. 
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.
Det må kun ordineres af eller under opsyn af en speciallæge med erfaring i håndtering af basalcelle-carcinom. 
It should only be prescribed by or under the supervision of a specialist doctor experienced in managing basal cell carcinoma.
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. 
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.
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. 
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.
Vismodegib knytter sig til et protein, der kaldes SMO, som er involveret i aktivering af hedgehog-signaleringsvejen. 
Vismodegib attaches to a protein called ‘SMO', which is involved in activating the Hedgehog signalling pathway.
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. 
For more information about treatment with Erivedge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvilke risici er der forbundet med Erivedge? 
What are the risks associated with Erivedge?
Det må ikke anvendes sammen med prikbladet perikon (urtemedicin, der anvendes mod depression). 
It must not be used together with St John's wort (a herbal medicine used to treat depression).
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. 
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.
I tilfælde af basalcelle-carcinom bliver hedgehog-signaleringsvejen abnormt aktiv, hvilket fører til vækst og spredning af kræftcellerne. 
In basal cell carcinoma, the Hedgehog signalling pathway becomes abnormally active and leads to the growth and spread of the cancerous cells.
Ved at knytte sig til SMO blokerer vismodegib denne vej og bremser derved vækst og spredning af kræftcellerne i tilfælde af basalcelle-carcinom. 
By attaching to SMO, vismodegib blocks this pathway, thereby slowing down the growth and spread of the cancer cells in basal cell carcinoma.
Hvis du ønsker praktisk vejledning om anvendelsen af Erivedge, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Erivedge, patients should read the package leaflet or contact their doctor or pharmacist.
Hvordan anvendes Erivedge? 
How is Erivedge used?
Hvilke fordele viser undersøgelserne, at der er ved Erivedge? 
What benefits of Erivedge have been shown in studies?
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. 
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.
Hvordan virker Erivedge? 
How does Erivedge work?
Mælk: 7 dage. 
Milk: 7 days.
Den beregnede gennemsnitlige halveringstid er 20,41 dage. 
The mean half-life calculated is 20.41 days.
Kød og indmad: som anbefalet i de pågældende afsnit af bilag III ovenfor. 
Meat and offal: as recommended in the relevant sections of Annex III above.
Normalt anvendes det i form af sulfatsaltet. 
It is normally used as the sulfate salt.
Dette er ikke en standardtilgang og omtales ikke i CVMP's vejledning. 
This is not a standard approach and is not referred to in CVMP guidance.
I dette tilfælde anbefales en ekstrapoleret tilbageholdelsestid på 228 dage. 
In that case an extrapolated withdrawal period of 228 days is recommended.
Undersøgelsens design er i overensstemmelse med gældende normer. 
The study design is in accordance with current standards.
Ansøger/indehaver af markedsføringstilladelse 
Applicant/Marketing Authorisation Holder
Det mikrobiologiske assay var fyldestgørende valideret. 
The microbiological assay was adequately validated.
Der indgik kun to dyr pr. slagtetidspunkt. 
Only two animals per slaughter point were involved.
Denne tilbageholdelsestid giver en bred sikkerhedsmargen i forhold til de foreliggende data. 
This withdrawal period includes a wide safety margin with regard to the available data.
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. 
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.
Der er ikke forelagt stabilitetsdata. 
No stability data were presented.
Undersøgelsens GLP-status kendes ikke. 
The GLP status of the study is not known.
Ved gentagne injektioner bør anvendes forskellige injektionssteder. 
Repeated injections should be made at different injection sites.