natgillin/translations-raw huggingface dataset:
Oprymea 1,57 mg depottabletter 10 depottabletter: EU/1/08/469/038 30 depottabletter: EU/1/08/469/039 90 depottabletter: EU/1/08/469/040 100 depottabletter: EU/1/08/469/041
Oprymea 1.57 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/038 30 prolonged-release tablets: EU/1/08/469/039 90 prolonged-release tablets: EU/1/08/469/040 100 prolonged-release tablets: EU/1/08/469/041
Oprymea 1,57 mg depottabletter
Oprymea 1.57 mg prolonged-release tablets
Hver depottablet indeholder 0,26 mg pramipexol (som 0,375 mg pramipexoldihydrochloridmonohydrat).
Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).
EU/1/08/469/050 [10 depottabletter] EU/1/08/469/051 [30 depottabletter] EU/1/08/469/052 [90 depottabletter] EU/1/08/469/053 [100 depottabletter]
EU/1/08/469/050 [10 prolonged-release tablets] EU/1/08/469/051 [30 prolonged-release tablets] EU/1/08/469/052 [90 prolonged-release tablets] EU/1/08/469/053 [100 prolonged-release tablets]
EU/1/08/469/006 [20 tabletter] EU/1/08/469/007 [30 tabletter] EU/1/08/469/008 [60 tabletter] EU/1/08/469/009 [90 tabletter] EU/1/08/469/010 [100 tabletter]
EU/1/08/469/006 [20 tablets] EU/1/08/469/007 [30 tablets] EU/1/08/469/008 [60 tablets] EU/1/08/469/009 [90 tablets] EU/1/08/469/010 [100 tablets]
EU/1/08/469/034 [10 depottabletter] EU/1/08/469/035 [30 depottabletter] EU/1/08/469/036 [90 depottabletter] EU/1/08/469/037 [100 depottabletter]
EU/1/08/469/034 [10 prolonged-release tablets] EU/1/08/469/035 [30 prolonged-release tablets] EU/1/08/469/036 [90 prolonged-release tablets] EU/1/08/469/037 [100 prolonged-release tablets]
Malta E. J. Busuttil Ltd.
România KRKA Romania S.R.L., Bucharest
I den første uge er dosis oftest 1 tablet Oprymea á 0,088 mg én gang daglig.
During the first week, the usual dose is 1 tablet Oprymea 0.088 mg once a day (equivalent to 0.088 mg daily):
EU/1/08/469/046 [10 depottabletter] EU/1/08/469/047 [30 depottabletter] EU/1/08/469/048 [90 depottabletter] EU/1/08/469/049 [100 depottabletter]
EU/1/08/469/046 [10 prolonged-release tablets] EU/1/08/469/047 [30 prolonged-release tablets] EU/1/08/469/048 [90 prolonged-release tablets] EU/1/08/469/049 [100 prolonged-release tablets]
Oprymea 0,52 mg depottabletter Pramipexol
Oprymea 0.52 mg prolonged-release tablets Pramipexole
Oprymea 0,52 mg depottabletter 10 depottabletter: EU/1/08/469/030 30 depottabletter: EU/1/08/469/031 90 depottabletter: EU/1/08/469/032 100 depottabletter: EU/1/08/469/033
Oprymea 0.52 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/030 30 prolonged-release tablets: EU/1/08/469/031 90 prolonged-release tablets: EU/1/08/469/032 100 prolonged-release tablets: EU/1/08/469/033
Oprymea 1,57 mg depottabletter Pramipexol
Oprymea 1.57 mg prolonged-release tablets Pramipexole
Kan forekomme hos mellem 1 og 10 ud af 100 patienter Ikke almindelig Kan forekomme hos mellem 1 og 10 ud af 1000 patienter Sjælden
Very common may affect more than 1 in 10 people Common may affect up to 1 in 10 people
Oprymea 0,26 mg depottabletter 10 depottabletter: EU/1/08/469/026 30 depottabletter: EU/1/08/469/027 90 depottabletter: EU/1/08/469/028 100 depottabletter: EU/1/08/469/029
Oprymea 0.26 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/026 30 prolonged-release tablets: EU/1/08/469/027 90 prolonged-release tablets: EU/1/08/469/028 100 prolonged-release tablets: EU/1/08/469/029
Oprymea 0,52 mg depottabletter
Oprymea 0.52 mg prolonged-release tablets
Hver depottablet indeholder 0,52 mg pramipexol (som 0,75 mg pramipexoldihydrochloridmonohydrat).
Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg pramipexole dihydrochloride monohydrate).
Oprymea 0,26 mg depottabletter Hver depottablet indeholder 0,26 mg pramipexol (som 0,375 mg pramipexoldihydrochloridmonohydrat).
Oprymea 0.26 mg prolonged-release tablets Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).
EU/1/08/469/030 [10 depottabletter] EU/1/08/469/031 [30 depottabletter] EU/1/08/469/032 [90 depottabletter] EU/1/08/469/033 [100 depottabletter]
EU/1/08/469/030 [10 prolonged-release tablets] EU/1/08/469/031[30 prolonged-release tablets] EU/1/08/469/032[90 prolonged-release tablets] EU/1/08/469/033[100 prolonged-release tablets]
Oprymea 1,05 mg depottabletter Pramipexol
Oprymea 1.05 mg prolonged-release tablets Pramipexole
Oprymea 2,1 mg depottabletter Pramipexol
Oprymea 2.1 mg prolonged-release tablets Pramipexole
Kan forekomme hos mellem 1 og 10 ud af 10.000 patienter
Common may affect up to 1 in 10 people
EU/1/08/469/038 [10 depottabletter] EU/1/08/469/039 [30 depottabletter] EU/1/08/469/040 [90 depottabletter] EU/1/08/469/041 [100 depottabletter]
EU/1/08/469/038 [10 prolonged-release tablets] EU/1/08/469/039 [30 prolonged-release tablets] EU/1/08/469/040 [90 prolonged-release tablets] EU/1/08/469/041 [100 prolonged-release tablets]
Behandlingsophør
Treatment discontinuation
Hvis du tager beroligende medicin og drikker alkohol, kan Oprymea påvirke din evne til at køre bil og håndtere maskiner.
In these cases Oprymea may affect your ability to drive and operate machinery.
Hvide til næsten hvide, runde (10 mm i diameter), let hvælvede tabletter, præget med P3 på den ene side, med skrå kanter og muligvis plettede.
White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P3 on one side, with bevelled edges and possible spots.
EU/1/08/469/026 [10 depottabletter] EU/1/08/469/027 [30 depottabletter] EU/1/08/469/028 [90 depottabletter] EU/1/08/469/029 [100 depottabletter]
EU/1/08/469/026 [10 prolonged-release tablets] EU/1/08/469/027 [30 prolonged-release tablets] EU/1/08/469/028 [90 prolonged-release tablets] EU/1/08/469/029 [100 prolonged-release tablets]
Hvide til næsten hvide, runde (10 mm i diameter), let hvælvede tabletter, præget med P4 på den ene side, med skrå kanter og muligvis plettede.
White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P4 on one side, with bevelled edges and possible spots.
Hvide til næsten hvide, runde (10 mm i diameter), let hvælvede tabletter, præget med P1 på den ene side, med skrå kanter og muligvis plettede.
White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P1 on one side, with bevelled edges and possible spots.
1 tablet Oprymea 1,1 mg 3 gange om dagen
1 tablet Oprymea 0.088 mg 1 tablet Oprymea 1.1 mg three three times a day times a day
Hvide til næsten hvide, runde (10 mm i diameter), let hvælvede tabletter, præget med P12 på den ene side, med skrå kanter og muligvis plettede.
White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P12 on one side, with bevelled edges and possible spots.
Oprymea 2,1 mg depottabletter
Oprymea 2.1 mg prolonged-release tablets
Oprymea 0,26 mg depottabletter Pramipexol
Oprymea 0.26 mg prolonged-release tablets Pramipexole
Hvide til næsten hvide, runde (10 mm i diameter), let hvælvede tabletter, præget med P2 på den ene side, med skrå kanter og muligvis plettede.
White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P2 on one side, with bevelled edges and possible spots.
Oprymea 0,26 mg depottabletter Oprymea 0,52 mg depottabletter Oprymea 1,05 mg depottabletter
Oprymea 0.26 mg prolonged-release tablets Oprymea 0.52 mg prolonged-release tablets Oprymea 1.05 mg prolonged-release tablets
Ikke almindelig: - Trang til unormal adfærd* - Hjertesvigt (hjerteproblemer, der kan forårsage åndenød eller hævede ankler)* - Uhensigtsmæssig udskillelse af antidiuretisk hormon
Uncommon: - Urge to behave in an unusual way* - Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* - Inappropriate antidiuretic hormone secretion* - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) - Hyperkinesia (increased movements and inability to keep still)* - Paranoia (e.g. excessive fear for one's own well-being)* - Delusion* - Amnesia (memory disturbance)*
Oprymea 0,26 mg depottabletter
Oprymea 0.26 mg prolonged-release tablets
Oprymea med 0,26 mg depottabletter er hvide til næsten hvide, runde (10 mm i diameter), let hvælvede tabletter, præget med P1 på den ene side, med skrå kanter og muligvis plettede.
What Oprymea looks like and contents of the pack Oprymea 0.26 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P1 on one side, with bevelled edges and possible spots.
Viread fik en markedsføringstilladelse med gyldighed i hele EU den 5. februar 2002.
Viread received a marketing authorisation valid throughout the EU on 5 February 2002.
Yderligere information om Viread findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/viread.
Further information on Viread can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/viread.
Hvad er Viread, og hvad anvendes det til?
What is Viread and what is it used for?
Som for alle lægemidler er data vedrørende brug af Viread løbende overvåget.
As for all medicines, data on the use of Viread are continuously monitored.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Viread?
What measures are being taken to ensure the safe and effective use of Viread?
Sjældne tilfælde af svære nyreproblemer er også blevet konstateret hos patienter behandlet med Viread.
Rare cases of severe kidney problems have also been seen in patients treated with Viread.
Viread anvendes i kombination med andre hivlægemidler.
Viread is used in combination with other HIV medicines.
En oversigt over Viread, og hvorfor det er godkendt i EU
An overview of Viread and why it is authorised in the EU
Bivirkninger rapporteret for Viread vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Viread are carefully evaluated and any necessary action taken to protect patients.
Hvorfor blev Viread godkendt i EU?
Why is Viread authorised in the EU?
For mere information om brug af Viread, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
For more information about using Viread, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Viread opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Viread's benefits are greater than its risks and it can be authorised for use in the EU.
Dosis skal muligvis reduceres, eller lægemidlet gives mindre hyppigt, hos patienter, der har moderat eller svært nedsat nyrefunktion.
The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function.
Desuden kan Viread forårsage en reduktion i knoglevævstætheden.
Moreover, Viread may cause a reduction in bone density.
Når Viread tages i kombination med andre antivirale lægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
Viread, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Ved behandling af hiv var Viread mere effektivt end placebo (en uvirksom behandling), når det blev føjet til en eksisterende behandling.
For the treatment of HIV, Viread was more effective than placebo (a dummy treatment) when added to existing treatment.
Hvilke risici er der forbundet med Viread?
What are the risks associated with Viread?
Viread helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
Viread does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Andre oplysninger om Viread
Other information about Viread:
Viread forhindrer virusset i at danne DNA og forhindrer derved, at det formerer sig og spredes.
Viread stops the virus making DNA and prevents it from multiplying and spreading.
Selv om der ikke sås nogen fordel ved at føje Viread til en eksisterende behandling, når man sammenlignede med placebo, medførte Viread tilsvarende niveauer af det aktive stof i kroppen, når man sammenlignede med voksne, og det skønnedes, at resultaterne var påvirkede af typen af patienter i Viread-gruppen.
Although it showed no benefit of adding Viread to existing treatment compared with adding placebo, Viread produced similar levels of the active substance in the body compared to adults, and it was judged that the results were influenced by the type of patients included in the Viread group.
Virksomheden, der markedsfører Viread, vil sikre, at alle læger, som forventes at ordinere eller anvende lægemidlet til børn, får udleveret informationsmateriale, der indeholder sikkerhedsoplysninger, navnlig om risici og forholdsregler med hensyn til nyrefunktion og knogler.
The company that makes Viread will ensure that all doctors who are expected to prescribe or use Viread in children are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones.
Viread (tenofovirdisoproxil)
Viread (tenofovir disoproxil)
Hos børn og unge anvendes det kun til patienter, der ikke kan førstevalgsbehandles med andre nukleotide reverse transkriptasehæmmere (NRTI).
In children and adolescents it is only used in patients who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI).
Ved kombinationsbehandlingen med Viread og emtricitabin var tallet 88 %.
The figure for the combination treatment of Viread and emtricitabine was 88%.
Ved hivinfektion virker det ved at blokere revers transkriptase, et enzym, der produceres af hiv, så det kan inficere celler og producere flere virus.
In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
De hyppigste bivirkninger ved Viread (som optræder hos mere end 1 ud af 10 patienter) er kvalme, opkastning, diarré, svimmelhed, hypofosfatæmi (lavt fosfatindhold i blodet), udslæt og asteni (svaghed).
The most common side effects with Viread (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, dizziness, hypophosphataemia (low levels of phosphate in the blood), rash and asthenia (weakness).
Tenofovir påvirker også virkningsmekanismen hos et enzym produceret af hepatitis B-virusset kaldet "DNA-polymerase", som indgår i dannelsen af viralt DNA.
Tenofovir also interferes with the action of an enzyme produced by the hepatitis B virus called DNA polymerase, which is involved in the formation of viral DNA.
Tenofovir er en nukleotid revers transkriptasehæmmer (NRTI).
Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI).
Det aktive stof i Viread, tenofovirdisoproxil, er et "prodrug", der i kroppen omdannes til tenofovir.
The active substance in Viread, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body.
I et studie blandt 87 unge (i alderen 12-18 år) undersøgte man virkningerne af at føje Viread til en eksisterende behandling.
A study carried out in 87 adolescents (12 to 18 years of age) investigated the effects of adding Viread to existing treatment.
For så vidt angår patienter, der tidligere har fået lægemidler mod hivinfektion, skal lægen inden ordinering af Viread gennemgå de antivirale lægemidler, patienten tidligere har taget, og vurdere sandsynligheden for, at virusset reagerer på antivirale lægemidler.
For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Viread once they have looked at the antiviral medicines the patient has taken before or the likelihood that the virus will respond to antiviral medicines.
Viread udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion eller kronisk hepatitis B. Viread, der fås som tabletter og som granulat, tages én gang dagligt sammen med et måltid.
Viread can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B. Viread, available as tablets and as granules, is taken once a day with food.
Viread er et lægemiddel, der anvendes til behandling af patienter i alderen 2 år og opefter, som er smittet med humant immundefektvirus type 1 (hiv-1), et virus, som forårsager erhvervet immundefektsyndrom (aids).
Viread is a medicine used to treat patients aged 2 years and above infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Hos voksne kan det også anvendes til patienter med leverskader, hvor leveren ikke fungerer korrekt (dekompenseret leversygdom), og til patienter, som ikke reagerer på behandling med lamivudin (et andet lægemiddel mod hepatitis B).
In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B infection).
Den fuldstændige liste over bivirkninger og begrænsninger ved Viread fremgår af indlægssedlen.
For the full list of side effects and restrictions with Viread, see the package leaflet.
I et tredje studie var Viread lige så effektivt som et andet lægemiddel, stavudin, når det blev føjet til lamivudin og efavirenz.
In a third study Viread was as effective as another medicine stavudine, when added to lamivudine and efavirenz.
I det ene af disse studier indgik patienter med "HBeAg-negativ" hepatitis B, en type, der er vanskeligere at behandle, mens det andet vedrørte den mere almindelige "HBeAg-positive" hepatitis B. Efter 48 uger udviste 71 % af de HBeAg-negative og 67 % af de HBeAg-positive patienter, der tog Viread, en fuldstændig respons på behandlingen, sammenlignet med henholdsvis 49 % og 12 % af de patienter, der tog adefovirdipivoxil.
One of these studies involved patients with ‘HBeAg-negative' hepatitis B, a type that is more difficult to treat, while the other involved the more common ‘HBeAgpositive' hepatitis B. After 48 weeks, 71% of the HBeAg-negative and 67% of HBeAg-positive patients taking Viread had a complete response to treatment, compared with 49% and 12%, respectively, of the patients taking adefovir dipivoxil.
Viread indeholder det aktive stof tenofovirdisoproxil.
Viread contains the active substance tenofovir disoproxil.
Samlet set havde 70 % af de patienter, der tog Viread eller entecavir, en virusbelastning på under 400 kopier/ml.
Overall, 70% of patients taking Viread or entecavir had a viral load below 400 copies/ml.
Viread anvendes også til behandling af kronisk hepatitis B-virusinfektion hos voksne og hos børn fra 2 år og opefter med leverskader, hvor leveren stadig fungerer korrekt (kompenseret leversygdom).
Viread is also used to treat chronic (long-term) hepatitis B virus infection in adults and children aged 2 years and above with liver damage whose liver is still working properly (compensated liver disease).
Hvordan anvendes Viread?
How is Viread used?
Det viste sig, at flertallet af dem, der skiftede fra behandling med stavudin eller zidovudin, bevarede deres lave niveau af hiv i blodet ved skift til Viread (83 % af børnene i Viread-gruppen og 92 % af dem, der tog stavudin eller zidovudin, havde en virusbelastning på under 400 kopier/ml efter 48 uger).
It showed that the majority of those who switched treatment from stavudine or zidovudine maintained their low HIV blood levels on Viread (83% of children in the Viread group and 92% of those on stavudine or zidovudine had viral loads below 400 copies/ml after 48 weeks).
Ved behandling af hepatitis B blev der i to studier blandt 641 voksne patienter foretaget en sammenligning mellem Viread og et andet lægemiddel, adefovirdipivoxil.
For the treatment of hepatitis B, two studies involving 641 adult patients compared Viread with another medicine, adefovir dipivoxil.
89 % af de patienter, der tog Viread, havde en virusbelastning på under 400 kopier/ml efter 96 ugers behandling sammenlignet med 86 % af de patienter, der tog Viread og emtricitabin som kombinationsbehandling.
89% of patients taking Viread had a viral load below 400 copies/ml after 96 weeks of treatment, compared with 86% of patients taking the combination treatment of Viread and emtricitabine.
Hvilke fordele viser studierne, at der er ved Viread?
What benefits of Viread have been shown in studies?
I et tredje studie, der omfattede 112 voksne, hvis lever var ophørt med at fungere korrekt (dekompenseret leversygdom), blev Viread sammenlignet med entecavir og en kombinationsbehandling med Viread og emtricitabin.
In a third study involving 112 adults whose liver had stopped working properly (decompensated liver disease) Viread was compared with entecavir and a combination treatment of Viread and emtricitabine.
Et tilsvarende antal patienter i Viread- og stavudin-gruppen havde en virusbelastning på under 400 kopier/ml efter 48 uger.
Similar numbers of patients in the Viread and stavudine groups had viral loads below 400 copies/ml after 48 weeks.
Af to studier blandt 741 hivsmittede voksne, fremgik det, at Viread medførte et fald i mængden af hiv i blodet (virusbelastningen) på ca. 75 % efter 4 og efter 24 uger sammenlignet med en lille stigning eller et lille fald i virusbelastningen på ca. 5 % hos de patienter, der tog placebo.
Two studies involving 741 HIV-infected adults showed that Viread resulted in a fall in the levels of HIV in the blood (viral load) of around 75% after 4 and after 24 weeks, compared with a small rise or fall in viral load of around 5% in the patients taking placebo.
I et studie blandt 97 børn (i alderen 2-12 år), som blev behandlet med stavudin eller zidovudin, sammenlignede man virkningerne af at skifte til behandling med Viread med virkningerne af at fortsætte en hidtidig behandling.
A study in 97 children (aged 2 to 12 years) treated with stavudine or zidovudine, compared the effects of switching their treatment to Viread with continuing previous treatment.
I et fjerde studie blandt 280 voksne, som ikke havde responderet på behandling med lamivudin, blev Viread som enkeltstofbehandling sammenlignet med Viread og emtricitabin som kombinationsbehandling.
A fourth study, involving 280 adults who had not responded to treatment with lamivudine, compared Viread alone with a combination treatment of Viread and emtricitabine.
Lignende resultater sås i et studie blandt 89 børn i alderen 2-12 år: Hos 77 % af de patienter, der tog Viread, faldt virusbelastningen til under 400 kopier/ml efter 48 uger sammenlignet med 7 % af de patienter, der tog placebo.
In a study in 89 children aged between 2 and 12 years the results were similar: 77% of patients on Viread had a viral load reduced to below 400 copies/ml after 48 weeks compared with 7% of patients on placebo.
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 Viread.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Viread have also been included in the summary of product characteristics and the package leaflet.
I et studie blandt 106 unge med enten HBeAg-negativ eller HBeAg-positiv hepatitis B blev Viread sammenlignet med placebo.
A study in 106 adolescents with either HBeAg-negative or HBeAg-positive hepatitis B compared Viread with placebo and found that in 88% of patients taking Viread the viral load reduced to below 400 copies/ml after 72 weeks compared with 0% of those taking placebo.
Hvordan virker Viread?
How does Viread work?
--1 Rekombinant verotoksin 2e fra E. coli ................................................... RP* ≥ 1,50 * RP - relativ styrke (ELISA)
--1 Recombinant verotoxin 2e of E. coli……………..RP* ≥ 1.50 * RP - relative potency (ELISA)
0 dage
10 vials
Lægemiddelform Dyrearter, som lægemidlet er beregnet til
Strength Pharmaceutical form
En procedure under artikel 29, stk. 4, blev derfor iværksat i februar 2012.
A procedure under Article 29(4) was therefore triggered in February 2012.