natgillin/translations-raw huggingface dataset:
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.
Hæmoglobin er det protein, der findes i de røde blodlegemer, som transporterer ilt rundt i kroppen.
Haemoglobin is the protein in red blood cells that carries oxygen around the body.
Erytropoietin dannes i nyrerne.
Erythropoietin is produced by the kidneys.
Erytropoietin kan desuden anvendes inden kirurgiske indgreb til at øge antallet af røde blodlegemer, så patienterne producerer mere blod, de kan donere til eget brug under indgrebet.
Erythropoietin is also used before surgery to increase the number of red blood cells to help patients produce more blood for self-donation.
Et hormon kaldet erythropoietin stimulerer dannelsen af røde blodlegemer i rygmarven.
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Det må desuden ikke anvendes til patienter, der har fået aplastisk anæmi (nedsat eller ophørt produktion af røde blodlegemer) efter behandling med en hvilken som helst form for erytropoietin, patienter med for højt blodtryk, der ikke er velreguleret, patienter, der skal have foretaget kirurgiske indgreb, og som har svære hjerte-karproblemer, herunder nyligt hjerteanfald eller slagtilfælde, patienter, der ikke må få blodfortyndende medicin.
It must not be used in patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin, patients with hypertension (high blood pressure) that is not controlled, patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke, or patients who cannot receive medicines to prevent blood clots.
• til at øge den mængde blod, som kan tages fra patienter med let anæmi før et kirurgisk indgreb, således at de kan donere blod til eget brug under eller efter indgrebet,
• to increase the amount of blood that patients with moderate anaemia can self-donate before surgery, so that their own blood can be given back to them during or after surgery;
I undersøgelsen af patienter, der allerede var i behandling med epoetin, blev hæmoglobinniveauet fastholdt på ca. 11,4 g/dl ved behandling med Retacrit og ved behandling med Eprex/Erypo.
In the study of patients already being treated with an epoetin, haemoglobin levels were maintained at around 11.4 g/dl when the patients were receiving Retacrit and when they were receiving Eprex/Erypo.
Retacrit var lige så effektivt som Eprex/Erypo til at øge og opretholde antallet af røde blodlegemer.
Retacrit was as effective as Eprex/Erypo in correcting and maintaining red blood cell counts.
Til patienter i kemoterapi gives det som indsprøjtning under huden, og hos patienter, der skal have foretaget et kirurgisk indgreb, gives det som indsprøjtning i en vene.
For patients receiving chemotherapy, it must be injected under the skin, and for patients about to undergo surgery, it must be injected into a vein.
Hvorfor blev Retacrit godkendt?
Why has Retacrit been approved?
• til at nedsætte behovet for blodtransfusioner hos patienter med moderat anæmi, som skal gennemgå en større knogleoperation (så som udskiftning af en hofte eller et knæ)
• to reduce the need for blood transfusions in patients with moderate anaemia about to undergo major bone surgery (such as a hip or knee replacement).
I undersøgelsen af stoffets evne til at øge antallet af røde blodlegemer var hæmoglobinniveauet cirka 11,6 g/dl gennem de sidste fire uger af undersøgelsen i forhold til cirka 8,0 g/dl inden behandlingens start.
In the correction study, haemoglobin levels were around 11.6 g/dl during the last four weeks of the study, having risen from around 8.0 g/dl before treatment.
• til at behandle anæmi (lavt antal røde blodlegemer), som giver symptomer hos patienter med ‘kronisk nyreinsufficiens' (langvarig, fremadskridende nedsættelse af nyrefunktionen) eller andre nyreproblemer,
• to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Retacrit kan desuden give hududslæt og influenza- eller forkølelseslignende symptomer.
Retacrit can also lead to skin rash and influenza (flu)-like symptoms.
Behandlingens virkning blev i begge undersøgelser hovedsagelig bedømt på blodets indhold af hæmoglobin i løbet af behandlingen og på den modtagne dosis epoetin.
In both studies, the main measures of effectiveness were the levels of haemoglobin during treatment, as well as the dose of epoetin received.
Hvad er Retacrit?
What is Retacrit?
Hvilken fordel viser undersøgelserne, at der er ved Retacrit?
What benefit has Retacrit shown during the studies?
I den anden undersøgelse sammenlignedes Retacrits og Eprex'/Erypos evne til at fastholde antallet af røde blodlegemer hos 313 patienter.
The second study compared the effects of Retacrit with those of Eprex/Erypo in maintaining red blood cell counts in 313 patients.
Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Eprex/Erypo.
Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks.
I den første undersøgelse blev Retacrits og Eprex'/Erypos evne til at øge antallet af røde blodlegemer sammenlignet hos 609 patienter over 24 uger.
The first study compared the effects of Retacrit with those of Eprex/Erypo in correcting red blood cell counts in 609 patients over 24 weeks.
Hvordan blev Retacrit undersøgt?
How has Retacrit been studied?
Retacrit er en injektionsvæske, opløsning.
Retacrit is a solution for injection.
Hvad anvendes Retacrit til?
What is Retacrit used for?
Hvordan anvendes Retacrit?
How is Retacrit used?
Den mest almindelige bivirkning ved Retacrit er øget blodtryk, hvilket også gælder for andre lægemidler, der indeholder epoetin.
As with other medicines containing an epoetin, the most common side effect with Retacrit is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden stabbing migraine-like headache and confusion.
Forsøgsmodeller og undersøgelser hos mennesker har vist, at Retacrit er sammenligneligt med referencelægemidlet Eprex/Erypo.
Retacrit was studied to show that it is comparable with the reference medicine, Eprex/Erypo, in experimental models and in humans.
Hvordan virker Retacrit?
How does Retacrit work?
Referencemedlemsstaten var Tyskland og de berørte medlemsstater var Finland og Det Forende Kongerige.
The Reference Member State was Germany and the Concerned Member States were Finland and the United Kingdom.
Der blev vedtaget en positiv udtalelse med flertal den 1. juni 2006.
A positive opinion was adopted by majority on 1 June 2006.
Den gensidige anerkendelsesprocedure indledtes den 24. marts 2005.
The Mutual Recognition Procedure started on 24 March 2005.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 21. august 2006.
The final opinion was converted into a Decision by the European Commission on 21 August 2006.
Voldgiftsproceduren indledtes den 15. september 2005 med vedtagelsen af liste med spørgsmål.
The arbitration procedure started on 15 September 2005 with the adoption of a list of questions.
Rapportør var dr. Broich og medrapportører var dr. Hudson og dr. Kuitunen.
The Rapporteur was Dr. Broich and Co-Rapporteurs were Dr. Hudson and Dr. Kuitunen.
Det Forenede Kongerige fremsendte begrundelserne for uenighederne til EMEA den 16. august 2005.
The United Kingdom referred the reasons for disagreement to the EMEA on 16 August 2005.
London, den 21.08.06 EMEA/CHMP/212746/2006
London, 21 August 2006 EMEA/CHMP/212746/2006
Indehaverne af markedsføringstilladelsen fremsendte skriftlige redegørelser den 28. november 2005.
The Marketing Authorisation Holder provided written explanations on 28 November 2005.
Dosisanbefalingen til nyfødte omfatter nemlig højere doser til nyfødte mellem 15-27 dage (80 mg/kg), mens standarddoseringen i Det Forenede Kongerige er 20-50mg/kg til nyfødte mellem 0-28 dage.
The posology in neonates where higher doses were proposed for neonates aged 15-27 days (80 mg/kg) while the standard dose is 20-50mg/kg in the UK for neonates 0-28 days.
Disse forskelle vedrører den anbefalede dosis og blev anset for at udgøre et alvorligt problem for folkesundheden.
This refers to the dosing recommendation for the newborn and this was considered to be of serious public health concern.
Det er indiceret til behandling af følgende infektioner, som skyldes mikroorganismer, der er følsomme over for ceftriaxon og som kræver parenteral behandling:
It is indicated for the treatment of the following infections when caused by micro-organisms that are susceptible to ceftriaxone and if parenteral treatment is necessary:
• Pneumonier Ceftriaxon er indiceret til perioperativ profylakse hos patienter med en vis risiko for alvorlig postoperativ infektion.
Ceftriaxone is indicated for perioperative prophylaxis in patients with a certain risk of severe postoperative infections.
Afhængigt af operationens art og det forventede patogenspektrum, bør ceftriaxon kombineres med et andet passende antibiotikum med yderligere anaerob dækning.
Depending on the mode of surgery and the expected spectrum of pathogens ceftriaxone should be combined with an appropriate antimicrobial agent with additional anaerobic coverage.
UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Ceftriaxon Tyrol Pharma og tilknyttede navne Internationalt fællesnavn (INN): Ceftriaxon
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Ceftriaxone Tyrol Pharma and associated names International Non-Proprietary Name (INN): Ceftriaxone
Der er påpeget væsentlige forskelle mellem det foreslåede produktresumé og produktresuméet for referenceproduktet i Det Forenede Kongerige.
Significant difference has been identified with regard to the proposed SPC compared to the SPC of the reference product in the UK.
Ceftriaxon Tyrol Pharma og tilknyttede navne 1 og 2 g pulver til injektionsvæske eller infusionsvæske, opløsning, er et antibiotikum, et cephalosporin af tredje generation.
Ceftriaxone Tyrol Pharma and associated names, 1g and 2 g powder for solution for injection/infusion, is an antibiotic, being a third generation cephalosporin.
Sandoz GmbH har indgivet ansøgning om gensidig anerkendelse af Ceftriaxon Tyrol Pharma og tilknyttede navne 1g og 2g opløsning til injektionsvæske eller infusionsvæske, opløsning, på grundlag af en markedsføringstilladelse udstedt af Tyskland den 13. august 2002.
Sandoz GmbH submitted applications for mutual recognition of Ceftriaxone Tyrol Pharma and associated names, 1g and 2g, solution for injection/infusion on the basis of the marketing authorisation granted by Germany on 13 August 2002.
I lyset af de samlede data, der var blevet fremlagt, og den faglige debat i udvalget var CHMP på sit møde i maj 2006 af den opfattelse, at benefit-risk forholdet er gunstigt for Ceftriaxon Tyrol Pharma og
During their May 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ceftriaxone Tyrol Pharma and associated names, that the objections raised by United Kingdom should
tilknyttede navne, at de af Det Forenede Kongerige rejste indvendinger ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.