natgillin/translations-raw huggingface dataset:
Relevant symptomatisk behandling bør administreres. 
These are rare and an appropriate symptomatic treatment should be administered.
Omrystes før brug. 
Shake well prior to use.
Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 dyr) - Ualmindelige (flere end 1, men færre end 10 dyr ud af 1.000 dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter) 
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN {DD/MM/ÅÅÅÅ} 
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {DD/MM/YYYY}
Vaccinen skal have en temperatur på 15°C - 25°C før ibrugtagning. 
Allow the vaccine to reach a temperature of 15°C-25°C.
SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Utilsigtet injektion er farlig. 
SPECIAL WARNING(S), IF NECESSARY Accidental injection is dangerous.
0 dage. 
Zero days
Ingen bivirkninger, andre end de under punkt 4.6 “Bivirkninger” nævnte, er blevet observeret efter administration af en overdosis. 
No undesirable effects other than those mentioned in section 4.6 have been observed after the administration of an overdose.
Farmakoterapeutisk gruppe: Immunologiske midler, bovin rhinotrakeitisvirus (IBR) ATCvet-kode: Q102AA03 
Pharmacotherapeutic group: Immunologicals, bovine rhinotracheitis virus (IBR) ATCvet code: QI02AA03
Hvis du ved et uheld injiceres med dette veterinærlægemiddel, skal du søge omgående lægehjælp, også selvom det kun drejer sig om en meget lille mængde, og tage indlægssedlen med dig. 
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
Anvend sterile sprøjter og kanyler. 
Use sterile syringes and needles.
Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel. 
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Frankrig 
Laboratoire Porte des Alpes Rue de l'Aviation-69800 Saint Priest France
Ingen bivirkninger, andre end de nævnt under punktet “Bivirkninger”, er blevet observeret efter administration af en overdosis. 
No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of an overdose.
MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER 5 doser (10 ml) 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 5 doses (10 ml)
EU/2/99/017/001 5 doser (10 ml) EU/2/99/017/004 10 x 5 doser (10 x 10 ml) EU/2/99/017/002 10 doser (20 ml) EU/2/99/017/005 10 x 10 doser (10 x 20 ml) EU/2/99/017/003 25 doser (50 ml) EU/2/99/017/006 10 x 25 doser (10 x 50 ml) 
EU/2/99/017/001 5 doses (10 ml) EU/2/99/017/004 10 x 5 doses (10 x 10 ml) EU/2/99/017/002 10 doses (20 ml) EU/2/99/017/005 10 x 10 doses (10 x 20 ml) EU/2/99/017/003 25 doses (50 ml) EU/2/99/017/006 10 x 25 doses (10 x 50 ml)
Injektion med vaccinen kan forårsage forbigående vævsreaktion på injektionsstedet, der kan persistere i tre uger, i sjældne tilfælde op til 5 uger. 
The injection of the vaccine may cause a transient tissue reaction at the site of injection, which may persist for three weeks and rarely up to five weeks.
25 doser (50 ml) 
25 doses (50 ml)
Bovalto Ibraxion kan anvendes som en markør vaccine i forbindelse med en passende diagnostisk testmetode. 
Bovalto Ibraxion can therefore be used as a marker vaccine in association with an appropriate diagnostic test.
BATCHNUMMER Lot{nummer} 
BATCH NUMBER
FREMSTILLERENS BATCHNUMMER Lot {nummer} 
MANUFACTURER'S BATCH NUMBER Lot
Kan anvendes til dyr fra 2 ugers alderen, ved fravær af maternelle antistoffer overfor IBR-virus eller fra 3 måneders alderen ved tilstedeværelse af maternelle antistoffer 
For use in animals from the age of 2 weeks in the absence of maternally derived antibodies against IBR virus or from the age of 3 months in the presence of maternally derived antibodies.
Paraffinolie, tynd Benzylalkohol Triethanolamin Polyoxyethylenoleat Polyoxyethylenoleylalkohol Kaliumchlorid Natriumchlorid Kaliumdihydrogenphosphat Dinatriumphosphatdihydrat Magnesiumchlorid Calciumchlorid 
Polyoxyethylene oleate Polyoxyethylene oleic alcohol Potassium chloride, Sodium chloride, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Magnesium chloride, Calcium chloride
1 dosis (2 ml) injiceres subkutant i halsmuskulaturen i henhold til følgende program: 
Administer one dose (2 ml) by subcutaneous injection in the neck (at the front of the shoulder) according to the following regimen:
Tilstedeværelse af maternelle antistoffer over for infektiøs bovin rhinotracheitis virus kan interferere med vaccinationen og kræver nøjagtig udført vaccinationsprogram. 
The presence of maternally derived antibodies against infectious bovine rhinotracheitis virus may interfere with the vaccination and requires an appropriate vaccination regimen.
Fjernelsen af gE-genet muliggør differentiering mellem dyr vaccineret med gE-negative vacciner (anti gE antistof negative, IBR vironeutraliserende antistof positive) og naturligt inficerede dyr (positive over for både IBR vironeutraliserende antistof og anti gE antistof). 
The gE gene deletion allows differentiation between animals vaccinated with gE-negative vaccines (anti gE antibody negative, IBR vironeutralising antibody positive) and naturally infected animals (positive to both IBR vironeutralising antibody and anti gE antibody).
Drægtighed og laktation: Bovalto Ibraxion kan anvendes under drægtighed og laktation. 
Pregnancy and lactation: Bovalto Ibraxion can be used during pregnancy and lactation.
Basisvaccination: to injektioner med et interval på 21 dage. 
Two injections 21 days apart.
MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Per dosis à 2 ml: gE-deleted, inaktiveret IBR-virus, min. ....................................................... 0,75 VN.U 
QUANTITY OF THE ACTIVE SUBSTANCE(S) For 1 dose of 2 ml: gE deleted inactivated IBR virus, at least ................................................ 0.75 VN.U
Fremstiller ansvarlig for batchfrigivelse Merial 
Manufacturer responsible for batch release MERIAL
Vaccinationen kan undtagelsesvis give anledning til overfølsomhedsreaktion. 
A hypersensitivity reaction may occur.
Bovalto Ibraxion can anvendes under drægtighed og laktation. 
Bovalto Ibraxion can be used during pregnancy and lactation.
A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURRER RESPONSIBLE FOR BATCH RELEASE
5 doser (10 ml) 10 x 5 doser (10 x 10 ml) 10 doser (20 ml) 10 x 10 doser (10 x 20 ml) 25 doser (50 ml) 10 x 25 doser (10 x 50 ml) 
5 doses (10 ml) 10 x 5 doses (10 x 10 ml) 10 doses (20 ml) 10 x 10 doses (10 x 20 ml) 25 doses (50 ml) 10 x 25 doses (10 x 50 ml)
TILBAGEHOLDELSESTID Tilbageholdelsestid: Nul dage. 
WITHDRAWAL PERIOD Withdrawal period: zero days.
Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Til brugeren: 
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktivt stof : 
QUALITATIVE AND QUANTITATIVE COMPOSITION
Indtræden af immunitet: 14 dage. 
Onset of immunity: 14 days
Fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af Bovalto Ibraxion er eller kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til national lovgivning. 
The manufacture, import, possession, sale, supply and/or use of Bovalto Ibraxion may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Æske med 1 eller 10 flasker á 5 doser (1 x 10 ml eller 10 x 10 ml) Æske med 1 eller 10 flasker á 10 doser (1 x 20 ml eller 10 x 20 ml) Æske med 1 eller 10 flasker á 25 doser (1 x 50 ml eller 10 x 50 ml) 
Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap Cardboard box with 1 or 10 bottles of 5 doses (1 x 10 ml or 10 x 10 ml) Cardboard box with 1 or 10 bottles of 10 doses (1 x 20 ml or 10 x 20 ml) Cardboard box with 1 or 10 bottles of 25 doses (1 x 50 ml or 10 x 50 ml)
TILBAGEHOLDELSESTID Tilbageholdelsestid: 0 dage 
WITHDRAWAL PERIOD Withdrawal period: Zero days
Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og/eller anvende Bovalto Ibraxion, skal rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik forinden fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse finder sted. 
Any person intending to manufacture, import, possess, sell, supply and/or use Bovalto Ibraxion must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession,sale, supply and/or use.
Opbevaringstid for veterinærlægemidlet i salgspakning: 18 måneder. 
Shelf life of the veterinary medicinal product as packaged for sale: 18 months Shelf life after first opening the immediate packaging: 6 hours
Aktiv immunisering af kvæg resulterende i en nedsættelse af kliniske symptomer på infektiøs bovin rhinotracheitis (IBR) og udskillelse af markvirus. 
Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
LÆGEMIDDELFORM Injektionvæske, emulsion. 
PHARMACEUTICAL FORM Emulsion for injection
INDLÆGSSEDDEL FOR: Bovalto Ibraxion emulsion til injektion 
PACKAGE LEAFLET FOR Bovalto Ibraxion emulsion for injection
Indførsel, besiddelse, salg, levering og/eller anvendelse af dette veterinærlægemiddel er eller kan være forbudt i en medlemsstat på dele af eller hele dens område. 
The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Aktiv immunisering af kvæg resulterende i en nedsættelse af kliniske symptomer på infektiøs bovin rhinotracheitis (IBR) og udskillelse af markvirus. 
4.2 Indications for use, specifying the target species Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
29 avenue Tony Garnier 69007 Lyon Frankrig 
29 avenue Tony Garnier 69007 LYON France
PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 5 doses (10 ml)
Må ikke anvendes efter den udløbsdato, som er angivet på etiketten efter EXP. 
Shelf life after first opening the container: 6 hours Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Indehaver af markedsføringstilladelse MERIAL 
Marketing authorisation holder MERIAL
VETERINÆRLÆGEMIDLETS NAVN Bovalto Ibraxion injektionsvæske, emulsion. 
NAME OF THE VETERINARY MEDICINAL PRODUCT Bovalto Ibraxion emulsion for injection
En dosis på 2 ml indeholder: gE-deleted, inaktiveret IBR-virus, min. ................................................................................. 0,75 VN.U* adjuvans: tynd paraffin olie ............................................................................................ 449,6 - 488,2 mg * VN.U: vironeutraliserende antistoftiter efter vaccination af marsvin 
Each dose (2 ml) contains: gE deleted inactivated IBR virus, at least ............................................................................. 0.75 VN.U* adjuvant: light paraffin oil ........................................................................................... 449.6 to 488.2 mg * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs.
Æske med 1 eller 10 flasker á 25 doser. 
Type I glass bottles with a Nitrile elastomer closure and sealed with an aluminium cap Cardboard box with 1 or 10 bottles of 5 doses Cardboard box with 1 or 10 bottles of 10 doses Cardboard box with 1 or 10 bottles of 25 doses
Vaccinen virker ved en aktiv immunisering af kvæg ved dannelse af Infektiøs Bovin Rhinotracheitis (IBR) vironeutraliserende antistoffer. 
Bovalto Ibraxion is a gene specific deleted (gE), inactivated and adjuvanted (o/w emulsion) vaccine which acts by the active immunisation of cattle characterised by the production of Infectious Bovine Rhinotracheitis (IBR) vironeutralising antibodies.
10. UDLØBSDATO EXP {måneder/år} 
EXPIRY DATE EXP {month/year} Once broached use by: 6 hours
• tynd paraffinolie ........................................................................................................ 449,6 - 488,2 mg * VN.U: vironeutraliserende antistoftiter efter vaccination af marsvin 
STATEMENT OF ACTIVE AND OTHER SUBSTANCES For 1 dose of 2 ml: .gE deleted inactivated IBR virus, at least ............................................................................ 0.75 VN.U* .light paraffin oil ......................................................................................................... 449.6 to 488.2 mg * VN.U: Vironeutralising antibody titre after vaccine injection in guinea pigs
BIVIRKNINGER 
Active substance
DYREARTER Kvæg. 
TARGET SPECIES
10. TILBAGEHOLDELSESTID 0 dage. 
WITHDRAWAL PERIOD Zero days
Retacrit anvendes i følgende situationer: 
Retacrit is used in the following situations:
Derefter skiftede begge grupper over til det andet lægemiddel i yderligere 12 uger. 
After that, the two groups switched to receiving the other medicine for a further 12 weeks.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Retacrit den 18. december 2007. 
The European Commission granted a marketing authorisation valid throughout the EU for Retacrit on 18 December 2007.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Retacrit. 
This document is a summary of the European Public Assessment Report (EPAR) for Retacrit.
Den fuldstændige EPAR for Retacrit findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
The full EPAR for Retacrit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den laveste dosis, som regulerer symptomerne tilstrækkeligt, skal anvendes. 
The lowest dose that provides adequate control of symptoms should be used.
Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Retacrit. 
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Retacrit.
Retacrit er et ‘biosimilært' lægemiddel. 
Retacrit is a ‘biosimilar' medicine.
Det fremstilles ved hjælp af en metode kaldet ‘rekombinant dna-teknologi': Det fremstilles af en celle, som har modtaget et gen (DNA), der sætter den i stand til at danne epoetin zeta. 
It is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin zeta.
Jernindholdet skal kontrolleres hos alle patienter inden behandling for at sikre, at det ikke er for lavt, og der bør gives jerntilskud under hele behandlingen. 
The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.
Det betyder, at Retacrit svarer til et biologisk lægemiddel (‘referencelægemidlet'), som allerede er godkendt i Den Europæiske Union (EU), og som indeholder det samme aktive stof. 
This means that Retacrit is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU), and contains a similar active substance to the reference medicine.
I begge undersøgelser var den anvendte dosis epoetin den samme for begge lægemidler. 
In both studies, the dose of epoetin received was similar with both medicines.
Det fås i fyldte injektionssprøjter, som indeholder mellem 1 000 og 40 000 internationale enheder (IE) af det aktive stof epoetin zeta. 
It is available in prefilled syringes containing between 1,000 and 40,000 international units (IU) of the active substance, epoetin zeta.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Retacrit. 
The Committee recommended that Retacrit be given marketing authorisation.
Retacrit må ikke gives til personer, der kan være overfølsomme (allergiske) over for epoetin zeta eller andre af indholdsstofferne. 
Retacrit should not be used in people who may be hypersensitive (allergic) to epoetin zeta or any of the other ingredients.
I disse tilfælde anvendes erytropoietin til at erstatte det manglende hormon eller til at øge antallet af røde blodlegemer. 
In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts.
Til patienter med kronisk nyreinsufficiens eller patienter i kemoterapi skal hæmoglobinniveauerne holdes inden for det anbefalede interval (mellem 10 og 12 gram pr. deciliter hos voksne og mellem 9,5 og 11 g/dl hos børn). 
For patients with chronic renal failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Retacrit var også effektivt, når det blev givet ved indsprøjtning under huden. 
Retacrit was also effective when it was injected under the skin.
Undersøgelsen hos patienter i kemoterapi viste, at Retacrit gav de samme forbedringer i hæmoglobinniveauet som dem, der er beskrevet i den videnskabelige litteratur for andre epoetiner. 
The study in patients receiving chemotherapy showed that Retacrit brought about similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins.
Behandling med Retacrit skal indledes under tilsyn af en læge, som har erfaring i behandling af patienter med de sygdomme, lægemidlet er beregnet til. 
Treatment with Retacrit must be started under the supervision of doctors who have experience in the management of patients with the conditions that the medicine is used for.
Retacrit var desuden lige så effektivt som referencelægemidlet hos patienter med nyreproblemer. 
Retacrit was also as effective as the reference medicine in patients with kidney problems.
De nærmere oplysninger om behandling med Retacrit fremgår af indlægssedlen (også en del af denne EPAR). 
For more information about treatment with Retacrit, read the Package Leaflet (also part of the EPAR).
Dosisstørrelsen, injektionshyppigheden og Retacrit-behandlingens varighed afhænger af, hvilken tilstand der behandles, og skal tilpasses patientens respons. 
The dose, the frequency of injection and how long Retacrit is used for depend on why it is being used, and are adjusted according to the patient's response.
Retacrit må ikke anvendes forud for større kirurgiske indgreb hos patienter, som har en svær sygdom, der berører deres arterier eller deres blodårer i hjertet, halsen eller hjernen, herunder patienter, som for nylig har haft et hjerteanfald eller slagtilfælde. 
Retacrit must not be used prior to major bone surgery in patients who have a severe disease affecting their arteries or their blood vessels in the heart, neck or brain, including patients who have recently had a heart attack or stroke.
• til at behandle anæmi hos voksne, som får kemoterapi for visse kræftformer, og til at mindske af behovet for blodtransfusioner, 
• to treat anaemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions;
Hvilken risiko er der forbundet med Retacrit? 
What is the risk associated with Retacrit?
Der findes yderligere oplysninger om biosimilære lægemidler i dokumentet med spørgsmål og svar her. 
For more information on biosimilar medicines, see the question-and-answer document here.
Den fuldstændige liste over alle de indberettede bivirkninger ved Retacrit fremgår af indlægssedlen. 
For the full list of all side effects reported with Retacrit, see the package leaflet.
Referencelægemidlet for Retacrit er Eprex/Erypo, som indeholder epoetin alfa. 
The reference medicine for Retacrit is Eprex/Erypo, which contains epoetin alfa.
Alle patienterne i den anden undersøgelse var blevet behandlet med Eprex/Erypo i mindst tre måneder, inden de skiftede over til Retacrit eller fortsatte behandlingen med Eprex/Erypo i 12 uger. 
All of the patients in the second study had been receiving treatment with Eprex/Erypo for at least three months before they were either switched to Retacrit or remained on Eprex/Erypo for 12 weeks.
Hos patienter i kemoterapi eller patienter med nyreproblemer kan der opstå anæmi, fordi de mangler erytropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på det naturligt dannede erytropoietin. 
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Virksomheden forelagde desuden resultaterne af to undersøgelser af virkningen af Retacrit indgivet ved indsprøjtning under huden: den ene omfattede 261 kræftpatienter, der var i kemoterapi, og den anden sammenlignede Retacrit med Eprex/Erypo hos 462 patienter med anæmi på grund af nyreproblemer. 
The company also presented the results of two studies looking at the effects of Retacrit injected under the skin: one involved 261 cancer patients receiving chemotherapy, and the other compared Retacrit with Eprex/Erypo in 462 patients with anaemia caused by kidney problems.
Retacrit kan indsprøjtes under huden af patienten selv eller af omsorgsgiveren, hvis de er behørigt instrueret heri. 
Retacrit can be injected under the skin by the patient or their carer if they have been trained appropriately.
Retacrit, indgivet i en vene, blev sammenlignet med referencelægemidlet i to hovedundersøgelser med 922 patienter, der havde anæmi efter langvarig nyresygdom, som nødvendiggjorde behandling med hæmodialyse (en teknik til at fjerne affaldsstoffer fra blodet). 
Retacrit, injected into a vein, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a technique for removing waste products from the blood).
Det aktive stof i Retacrit, epoetin zeta, er en kopi af det menneskelige erytropoietin og har nøjagtigt samme stimulerende virkning på dannelsen af røde blodlegemer som det naturlige hormon. 
The active substance in Retacrit, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
CHMP konkluderede, at det i overensstemmelse med EU-kravene er påvist, at Retacrits kvalitet, sikkerhed og virkning svarer til Eprex/Erypos. 
The CHMP concluded that, in accordance with EU requirements, Retacrit has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Andre oplysninger om Retacrit 
Other information about Retacrit:
Til patienter med nyreproblemer kan Retacrit gives ved indsprøjtning i en vene eller under huden. 
For patients with kidney problems, Retacrit can be injected into a vein or under the skin.