FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with baseline platelet count less than 180 × 109/L, thrombocytopenia of any grade and Grade 3/4 occurred in 76 % and 45 % of the patients, respectively.
Danish: Hos patienter med et trombocyttal ved baseline på mindre end 180 × 109/l sås trombocytopeni af alle grader hos 76 % af patienterne og af grad 3/4 hos 45 % af patienterne.
English: Each hard capsule contains 254.5 mg of lactose monohydrate (see section 4.4).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver hård kapsel indeholder 254,5 mg lactosemonohydrat (se pkt.
English: Approximately 30 % of patients receiving Zejula experienced neutropenia of any grade, and 20 % of patients experienced Grade 3/4 neutropenia.
Danish: Ca. 30 % af de patienter, som fik Zejula, oplevede neutropeni af alle grader, og 20 % af patienterne oplevede neutropeni af grad 3/4.
English: Following a single oral 300-mg dose of niraparib, the mean terminal half-life (t½) of niraparib ranged from 48 to 51 hours (approximately 2 days).
Danish: Efter en enkelt oral dosis niraparib på 300 mg lå niraparibs gennemsnitlige terminale halveringstid (t½) på 48-51 timer (ca. 2 dage).
English: Women of childbearing potential must use effective contraception during therapy and for 1 month after receiving the last dose of Zejula.
Danish: Kvinder i den fødedygtige alder skal anvende sikker prævention under behandlingen og i 1 måned efter den sidste dosis Zejula.
English: In the clinical programme, neutropenia was managed with laboratory monitoring and dose modifications (see section 4.2).
Danish: I det kliniske program blev neutropeni håndteret ved hjælp af laboratorieovervågning og dosisjusteringer (se pkt.
English: Approximately 76 % of patients with lower baseline platelets (< 180 × 109/L) who received Zejula experienced thrombocytopenia of any grade, and 45 % of the patients experienced Grade 3/4 thrombocytopenia.
Danish: Ca. 76 % af patienterne med en lav blodpladeværdi ved baseline (< 180 × 109/l), som fik Zejula, oplevede trombocytopeni (alle grader), og 45 % af patienterne oplevede trombocytopeni af grad 3-4.
English: Thrombocytopenia, anaemia, neutropenia
Danish: Trombocytopeni, anæmi, neutropeni
English: • Resume Zejula at a reduced dose.
Danish: Genoptag Zejula i nedsat dosis.
English: • Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥ 1,500/µL or haemoglobin returns to ≥ 9 g/dL.
Danish: Tilbagehold Zejula i maksimalt 28 dage, og overvåg blodtallene ugentligt, indtil neutrofiltallet igen er ≥ 1.500/µl, eller hæmoglobin igen er ≥ 9 g/dl.
English: Do not use this medicine if you notice any damage or signs of tampering to the pack.
Danish: Brug ikke dette lægemiddel, hvis emballagen er beskadiget eller brudt.
English: (Nir:plac) (95 % CI*) * CI denotes confidence interval.
Danish: (Nir:plac) (95 %-KI*)
English: Hypertension, including hypertensive crisis, has been reported with Zejula therapy.
Danish: Hypertension, herunder hypertensiv krise, er indberettet i forbindelse med behandling med Zejula.
English: Niraparib is not a substrate of MATE 1 or 2, while M1 is a substrate of both.
Danish: Niraparib er ikke et substrat for MATE 1 eller 2,
English: • Discontinue Zejula if neutrophils and/or haemoglobin have not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg QD.
Danish: Seponer Zejula, hvis neutrofiltallet og/eller hæmoglobin ikke er vendt tilbage til et acceptabelt niveau i løbet af de 28 dages dosisafbrydelse, eller hvis patientens dosis allerede er nedsat til 100 mg 1 gang dagligt.
English: The pharmacokinetics of niraparib have not been assessed in patients with severe hepatic impairment (see section 4.2).
Danish: Farmakokinetikken for niraparib hos patienter med svært nedsat leverfunktion er ikke undersøgt (se pkt.
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit (e.g. itraconazole, ritonavir, and clarithromycin) or induce CYP enzymes (e.g. rifampin, carbamazepine, and phenytoin).
Danish: Der kræves ingen dosisjustering af Zejula, når det administreres samtidig med lægemidler, der hæmmer CYP-enzymer (f.eks. itraconazol, ritonavir og clarithromycin) eller inducerer CYP-enzymer (f.eks. rifampicin, carbamazepin og phenytoin).
English: Zejula lowers your blood-cell counts, such as your red blood-cell count (anaemia), white blood-cell count (neutropenia), or blood-platelet count (thrombocytopenia).
Danish: Lave blodtal Zejula giver lave blodtal, f.eks. et lavt antal røde blodlegemer (blodmangel (anæmi)), hvide blodlegemer (neutropeni) eller blodplader (trombocytopeni).
English: Diarrhoea, constipation, mucosal inflammation (including mucositis), stomatitis, dry mouth
Danish: Diarré, obstipation, slimhindebetændelse (herunder mucositis), stomatitis, mundtørhed
English: If adverse reactions persist beyond a 28-day dose interruption, it is recommended that Zejula be discontinued.
Danish: Hvis bivirkningen varer ved ud over en dosisafbrydelse på 28 dage, bør Zejula seponeres.
English: PFS median (95% CI*)
Danish: PFS-median (95 %-KI*)
English: Nausea, constipation, vomiting, abdominal pain, diarrhoea, dyspepsia
Danish: Kvalme, obstipation, opkastning, mavesmerter, dyspepsi
English: Reproductive toxicology
Danish: Reproduktionstoksicitet
English: Confirmed diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukaemia
Danish: Bekræftet diagnose på myelodysplastisk syndrom (MDS) eller akut myeloid leukæmi (AML)
English: Zejula contains tartrazine (E 102)
Danish: Zejula indeholder tartrazin (E 102)
English: CTCAE ≥ Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered Zejula 100 mg/day
Danish: kriterierne), der varer i mere end 28 dage, mens patienten får Zejula 100 mg/dag
English: In the clinical programme, thrombocytopenia was managed with laboratory monitoring, dose modification and platelet transfusion where appropriate (see section 4.2).
Danish: I det kliniske program blev trombocytopeni håndteret ved hjælp af laboratorieovervågning, dosisjustering og trombocyttransfusion, hvor det var relevant (se pkt.
English: • Discontinue Zejula if the platelet count has not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg QD.
Danish: Seponer Zejula, hvis trombocyttallet ikke er vendt tilbage til et acceptabelt niveau i løbet af de 28 dages dosisafbrydelse, eller hvis patientens dosis allerede er nedsat til 100 mg 1 gang dagligt.
English: Approximately 60 % of patients receiving Zejula experienced thrombocytopenia of any grade, and 34 % of patients experienced Grade 3/4 thrombocytopenia.
Danish: Ca. 60 % af de patienter, som fik Zejula, oplevede trombocytopeni af alle grader, og 34 % af patienterne oplevede trombocytopeni af grad 3/4.
English: The cases were typical of secondary, cancer therapy-related MDS/AML.
Danish: Tilfældene var typiske for sekundært myelodysplastisk syndrom/akut myeloid leukæmi relateret til kræftbehandling.
English: • 56 × 1 hard capsules
Danish: • 56 × 1 hårde kapsler
English: How to take Zejula
Danish: Sådan skal du tage Zejula
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: ANGIVELSE AF AKTIVT STOF/ AKTIVE STOFFER
English: The median duration of neutropenia of any grade was 26 days, and 13 days for Grade 3/4 events.
Danish: Den mediane varighed af neutropeni af alle grader var 26 dage og 13 dage for hændelser af grad 3/4.
English: • 28 × 1 hard capsules
Danish: • 28 × 1 hårde kapsler
English: What Zejula is and what it is used for What you need to know before you take Zejula How to take Zejula
Danish: Virkning og anvendelse Det skal du vide, før du begynder at tage Zejula Sådan skal du tage Zejula Bivirkninger
English: Therefore, no dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit P-gp (e.g. amiodarone, verapamil) or BCRP (e.g. osimertinib, velpatasvir, and eltrombopag).
Danish: Der kræves derfor ingen dosisjustering af Zejula, når det administreres sammen med lægemidler, der hæmmer P-gp (f.eks. amiodaron, verapamil) eller BCRP (f.eks. osimertinib, velpatasvir og eltrombopag).
English: Back pain, arthralgia, myalgia
Danish: Rygsmerter, artralgi, myalgi
English: The median time to onset of neutropenia of any grade was 27 days, and 29 days for Grade 3/4 events.
Danish: Den mediane tid til starten af neutropeni af alle grader var 27 dage og 29 dage for hændelser af grad 3/4.
English: • 84 × 1 hard capsules
Danish: • 84 × 1 hårde kapsler
English: More patients in the niraparib group continued treatment for more than 12 months than patients in the placebo group (34.2 % and 21.1 %, respectively).
Danish: Der var flere patienter i niraparibgruppen end i placebogruppen, der fortsatte behandling i mere end 12 måneder (hhv. 34,2 % og
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OAT1 (e.g. probenecid) or OAT3 (e.g. probenecid, diclofenac), or OCT2 (e.g. cimetidine, quinidine) uptake transporters.
Danish: Der kræves ingen dosisjustering af Zejula, når det administreres samtidig med lægemidler, der hæmmer optagelsestransportørerne OAT1 (f.eks. probenecid), OAT3 (f.eks. probenecid, diclofenac) eller OCT2 (f.eks. cimetidin, quinidin).
English: Capsule content Magnesium stearate
Danish: Kapselindhold Magnesiumstearat Lactosemonohydrat
English: The systemic exposures (Cmax and AUC) to niraparib increased in a dose-proportional manner when the dose of niraparib increased from 30 mg to 400 mg.
Danish: De systemiske eksponeringer for niraparib (Cmax og AUC) steg proportionalt med dosis, når niraparibdosis blev øget fra 30 mg til 400 mg. Niraparibs absolutte biotilgængelighed er ca. 73 %, hvilket peger på en minimal first-pass effekt.
English: The median time to onset of anaemia of any grade was 42 days, and 85 days for Grade 3/4 events.
Danish: Den mediane tid til starten af anæmi af alle grader var 42 dage og 85 dage for hændelser af grad 3/4.
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OATP1B1 or 1B3 (e.g. gemfibrozil, ritonavir), or OCT1 (e.g. dolutegravir) uptake transporters.
Danish: Der kræves ingen dosisjustering af Zejula, når det administreres samtidig med lægemidler, der hæmmer optagelsestransportørerne OATP1B1 eller 1B3 (f.eks. gemfibrozil, ritonavir) eller OCT1 (f.eks. dolutegravir).
English: The median duration of anaemia of any grade was 63 days, and 8 days for Grade 3/4 events.
Danish: Den mediane varighed af anæmi af alle grader var 63 dage og 8 dage for hændelser af grad 3/4.
English: Swallow the capsules whole, with some water.
Danish: Kapslerne skal synkes hele sammen med vand.
English: In a mass balance study, M1 and M10 (the subsequently formed M1 glucuronides) were the major circulating metabolites.
Danish: Niraparib metaboliseres primært af carboxylesteraser (CE'er) og danner en væsentlig inaktiv metabolit, M1. I et massebalancestudie var M1 og M10 (de efterfølgende dannede M1-glucuronider) de væsentligste cirkulerende metabolitter.
English: There are no data in patients with severe hepatic impairment; use with caution in these patients (see section 5.2).
Danish: Anvendes med forsigtighed til disse patienter (se pkt.
English: Inhibition of hepatic uptake transporters (OATP1B1, OATP1B3, and OCT1) Neither niraparib nor M1 is an inhibitor of organic anion transport polypeptide 1B1 (OATP1B1) or 1B3 (OATP1B3).
Danish: Hæmning af hepatiske optagelsestransportører (OATP1B1, OATP1B3 og OCT1) Hverken niraparib eller M1 er en hæmmer af organisk aniontransportpolypeptid 1B1 (OATP1B1) eller 1B3 (OATP1B3).
English: • Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥ 100,000/µL.
Danish: Tilbagehold Zejula i maksimalt 28 dage, og overvåg blodtallene ugentligt, indtil trombocyttallet igen er ≥ 100.000/µl.
English: If you take more Zejula than you should
Danish: Hvis du har taget for meget Zejula
English: Reproductive and developmental toxicity studies have not been conducted with niraparib.
Danish: Der er ikke udført studier af niraparibs reproduktions- og udviklingstoksicitet.
English: • Nose bleed
Danish: • Næseblod
English: After the first month, it is recommended to monitor CBCs monthly and periodically after this time (see section 4.4).
Danish: Efter den første måned bør det komplette blodtal overvåges månedligt og derefter med jævne mellemrum (se pkt.
English: Common (may affect up to 1 in 10 people) Reduction in the number of white cells in the blood (leukopenia) Talk to your doctor if you get any other side effects.
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) • Nedsat antal hvide blodlegemer (leukopeni)
English: Niraparib as a substrate of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 is a substrate of organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Danish: Niraparib som et substrat for renale optagelsestransportører (OAT1, OAT3 og OCT2) Hverken niraparib eller M1 er et substrat for organisk aniontransportør 1 (OAT1), 3 (OAT3) og organisk kationtransportør 2 (OCT2).
English: Therefore, the PRAC concluded that “febrile neutropenia” should be added as a new adverse drug reaction in section 4.8 of the SmPC with the frequency “uncommon.” The package leaflet should be updated accordingly.
Danish: PRAC konkluderede derfor, at febril neutropeni bør tilføjes som en ny bivirkning under pkt.
English: ANNEX II
Danish: Appelhof 13
English: Inhibition of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 inhibits organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Danish: Hæmning af renale optagelsestransportører (OAT1, OAT3 og OCT2) Hverken niraparib eller M1 hæmmer organisk aniontransportør 1 (OAT1), 3 (OAT3) og organisk kationtransportør 2 (OCT2).
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
English: Fatigue, asthenia
Danish: Træthed, asteni
English: In the NOVA study, 48 of 367 (13 %) of patients experienced bleeding with concurrent thrombocytopenia; all bleeding events concurrent with thrombocytopenia were Grade 1 or 2 in severity except for one event of Grade 3 petechiae and haematoma observed concurrently with a serious adverse event of pancytopenia.
Danish: Alle blødningshændelser, der var samtidige med trombocytopeni, var af sværhedsgrad 1 eller 2, med undtagelse af ét tilfælde af petekkier og hæmatom af grad 3, der blev observeret samtidig med et alvorligt tilfælde af pancytopeni.
English: • Dizziness
Danish: • Vægttab
English: Dose modifications for haematologic adverse reactions
Danish: Dosisændringer ved hæmatologiske bivirkninger
English: Back pain, arthralgia
Danish: Rygsmerter, artralgi
English: There are no data in patients with severe renal impairment or end stage renal disease undergoing haemodialysis; use with caution in these patients (see section 5.2).
Danish: Der foreligger ingen data om patienter med svært nedsat nyrefunktion eller nyresygdom i slutfasen, som får hæmodialyse.
English: In the clinical programme, anaemia was managed with laboratory monitoring, dose modification (see section 4.2), and where appropriate with red blood cell transfusions.
Danish: I det kliniske program blev anæmi håndteret ved hjælp af laboratorieovervågning, dosisjustering (se pkt.
English: • Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to
Danish: Tilbagehold Zejula i maksimalt 28 dage, og overvåg det komplette blodtal ugentligt, indtil trombocyttallet igen er ≥ 100.000/µl.
English: • Stomach pain
Danish: • Oppustet mave
English: • Pink eye
Danish: • Øjenbetændelse
English: Myelodysplastic syndrome/acute myeloid leukaemia Rarely, low blood-cell counts may be a sign of more serious problems with the bone marrow such as
Danish: Lave blodtal kan i sjældne tilfælde være tegn på alvorligere problemer med knoglemarven, såsom "myelodysplastisk syndrom" (MDS) eller "akut myeloid leukæmi" (AML).
English: Dose adjustments for adverse reactions
Danish: Dosisjusteringer ved bivirkninger
English: Neither niraparib nor M1 is a substrate of organic anion transport polypeptide 1B1 (OATP1B1), 1B3 (OATP1B3), or organic cation transporter 1 (OCT1).
Danish: Niraparib som et substrat for hepatiske optagelsestransportører (OATP1B1, OATP1B3 og OCT1) Hverken niraparib eller M1 er et substrat for organisk aniontransportpolypeptid 1B1 (OATP1B1), 1B3 (OATP1B3) eller organisk kationtransportør 1 (OCT1).
English: • Feeling of weakness
Danish: • Svaghed
English: The European Commission issued a decision on 10 June 2016.
Danish: Europa-Kommissionen traf en afgørelse den 10. juni 2016.
English: 10 June 2016
Danish: 10. juni 2016
English: The company requested the authorisation to be recognised in Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom (the ‘concerned Member States').
Danish: Virksomheden ønskede at få godkendelsen anerkendt i Bulgarien, Kroatien, Frankrig, Tyskland, Irland, Italien, Nederlandene, Polen, Portugal, Rumænien, Slovenien, Spanien og Det Forenede Kongerige (de "berørte medlemsstater").
English: However, the Member States could not reach an agreement and the Belgian Federal Agency for Medicines and Health Products referred the matter to the CVMP for arbitration on 29 September 2015.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den belgiske sundhedsstyrelse indbragte sagen til CVMP med henblik på voldgift den 29. september 2015.
English: On 17 March 2016, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated).
Danish: Den 17. marts 2016 gennemførte Det Europæiske Lægemiddelagentur (Agenturet) en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelsen af lægemidlet CattleMarker IBR Inactivated, emulsion til injektion til kvæg (herefter kaldet CattleMarker IBR Inactivated).
English: What is CattleMarker IBR Inactivated?
Danish: Hvad er CattleMarker IBR Inactivated?
English: Zoetis Belgium SA submitted an application for CattleMarker IBR Inactivated for mutual recognition on the basis of the initial authorisation granted by Belgium.
Danish: Zoetis Belgium SA indsendte en ansøgning om gensidig anerkendelse af CattleMarker IBR Inactivated på grundlag af den oprindelige godkendelse udstedt af Belgien.
English: Why was CattleMarker IBR Inactivated reviewed?
Danish: Hvorfor blev CattleMarker IBR Inactivated vurderet?
English: CattleMarker IBR Inactivated is produced on the same bovine cell line and is adjuvanted with the same highly potent adjuvant as PregSure BVD.
Danish: CattleMarker IBR Inactivated fremstilles i samme bovine cellelinje og tilføres den samme højpotente adjuvans som PregSure BVD.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that subject to the conduct of additional studies and the implementation of further measures specified in a Risk Management Plan the marketing authorisation for CattleMarker IBR Inactivated should be granted in all concerned Member States.
Danish: På grundlag af evalueringen af de nuværende tilgængelige data og den videnskabelige diskussion i Komitéen konkluderede CVMP, at markedsføringstilladelsen for CattleMarker IBR Inactivated skal udstedes i alle berørte medlemsstater, forudsat at der gennemføres supplerende studier og yderligere foranstaltninger som angivet i risikostyringsplanen.
English: The grounds for the referral were concerns raised by Germany regarding the immunological safety of CattleMarker IBR Inactivated, as the composition and manufacture of this product are similar to PregSure BVD, a vaccine from Zoetis which has been shown to induce a long-lasting allogeneic antibody response that has been associated with Bovine Neonatal Pancytopenia, a neonatal alloimmune disease, in the progeny of vaccinated dams.
Danish: Årsagerne til indbringelsen var bekymringer, som Tyskland gav udtryk for, hvad angår den immunologiske sikkerhed ved CattleMarker IBR Inactivated, fordi produktet har samme sammensætning og fremstilling som PregSure BVD, en Zoetis-vaccine, som man har påvist inducerer langvarig allogen antistofrespons, hvilket har været forbundet med bovin neonatal pancytopeni (BNP), en neonatal alloimmun sygdom hos afkommet fra vaccinerede moderdyr.
English: Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac) EMA/290855/2016
Danish: Spørgsmål og svar om CattleMarker IBR Inactivated, emulsion til injektion til kvæg (inaktiveret gE bovin herpesvirus type 1 (BoHv-1), Difivac stamme EMA/290855/2016
English: The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection.
Danish: Produktet er indiceret til aktiv immunisering af seronegative kalve i alderen 2 uger og derover med henblik på at reducere de kliniske tegn på IBR (pyreksi og depression) og spredning af virus, der skyldes BoHV-1-infektion.
English: CattleMarker IBR Inactivated is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains inactivated glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac.
Danish: CattleMarker IBR Inactivated er en inaktiveret infektiøs bovin rhinotracheitis (IBR)-vaccine, der indeholder glykoprotein E (gE)-negativ bovin herpesvirus type 1 (BoHV-1) af Difivac-stammen.
English: Active immunisation of female cattle from 6 months of age is also indicated to reduce the clinical signs (pyrexia and duration of dyspnoea) of IBR and virus shedding caused by BoHV-1 infection and to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Danish: Aktiv immunisering af kviekalve i alderen 6 måneder og derover er også indiceret med henblik på at reducere de kliniske tegn på IBR (pyreksi og varigheden af dyspnø) og spredning af virus, der skyldes BoHV-1-infektion og med henblik på at reducere forekomsten af aborter i forbindelse med BoHV-1-infektion, typisk i drægtighedsperiodens andet trimester, efter eksponering.
English: Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac)
Danish: Spørgsmål og svar om CattleMarker IBR Inactivated, emulsion til injektion til kvæg (inaktiveret gE bovin herpesvirus type 1 (BoHv-1), Difivac stamme
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, subject to conditions relating to risk mitigation and surveillance measures, the marketing authorisation granted in Belgium for CattleMarker IBR Inactivated can be recognised in other Member States of the EU.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at markedsføringstilladelsen udstedt i Belgien for CattleMarker IBR Inactivated kan anerkendes i andre medlemsstater af EU, forudsat at betingelser i forbindelse med risikostyring og overvågning imødekommes.
English: The potential risk of recurrence of Bovine Neonatal Pancytopenia linked to the use of this vaccine in pregnant cows had been addressed by Zoetis; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by Zoetis.
Danish: Tyskland mener imidlertid, at den foreslåede håndtering af risiciene er utilstrækkelig, og at Zoetis bør iværksætte en omfattende undersøgelse efter tilladelse til markedsføring.