FrancophonIA/ELRC3.0 huggingface dataset:
English: • conjunctivitis (discharge with itching of the eyes and crusty eyelids)
Danish: • øjenbetændelse (udflåd med kløe i øjnene og skorper på øjenlågene)
English: Volume (mL) = Body weight (kg) x dose (4 mg/kg for loading or 2 mg/kg for maintenance)
Danish: Volumen (ml) = Legemsvægt (kg) x dosis (4 mg/kg som støddosis eller 2 mg/kg til vedligeholdelse)
English: Volume (mL) = Body weight (kg) x dose (8 mg/kg for loading or 6 mg/kg for maintenance)
Danish: Volumen (ml) = Legemsvægt (kg) x dosis (8 mg/kg som støddosis eller 6 mg/kg til vedligeholdelse)
English: which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles.
Danish: serier (dag 2 i serie 1, derefter dag 1 i hver af de efterfølgende serier), som blev efterfulgt af: - carboplatin - ved tilsigtet AUC = 6 mg/ml/min administreret som intravenøs infusion over 30-60 minutter gentaget hver 3. uge i samlet 6 serier.
English: Ogivri 420 mg powder for concentrate for solution for infusion 50 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 420 mg of trastuzumab.
Danish: Ogivri 420 mg pulver til koncentrat til infusionsvæske, opløsning 50 ml klart type I hætteglas med butylgummiprop lamineret med en fluor-resin-film.
English: • difficulty in breathing when lying flat
Danish: • problemer med at trække vejret i liggende stilling
English: Glomerulonephritis membranous
Danish: Membranøs glomerulonefritis
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 2: Table 2 Recommended scoring system to evaluate the IHC staining patterns in breast cancer Score Staining pattern
Danish: Det anbefalede scoringssystem til evaluering af de IHC-farvede mønstre er som angivet i tabel 2:
English: • failure of lungs to develop in the womb
Danish: • utilstrækkelig udvikling af fostrets lunger i livmoderen
English: Acute respiratory distress syndrome
Danish: Akut lungeødem
English: Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab
Danish: Ogivri 150 mg pulver til koncentrat til infusionsvæske, opløsning Ogivri 420 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
English: Ogivri 150 mg powder for concentrate for solution for infusion Ogivri 420 mg powder for concentrate for solution for infusion
Danish: Ogivri 150 mg pulver til koncentrat til infusionsvæske, opløsning Ogivri 420 mg pulver til koncentrat til infusionsvæske, opløsning
English: Table 7 Summary of efficacy results from the joint analysis of the NSABP B-31 and NCCTG N9831 trials at the time of the definitive DFS analysis*
Danish: Resumé af effektresultater fra den samlede analyse af NSABP B-31- og NCCTG N9831studierne efter den endelige analyse af sygdomsfri overlevelse*
English: Upper respiratory tract infection
Danish: Infektion i øvre luftveje
English: Ogivri is given as an infusion into a vein (intravenous infusion, drip), this intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only.
Danish: Denne intravenøse formulering er ikke beregnet til subkutan brug og må kun gives som en intravenøs infusion.
English: The recommended scoring system to evaluate the IHC staining patterns is as stated in Table 3: Table 3 Recommended scoring system to evaluate the IHC staining patterns in gastric cancer Score
Danish: Det anbefalede scoringssystem til evaluering af de IHC-farvede mønstre er som angivet i tabel 3:
English: • abnormal kidney development in the womb
Danish: • unormal udvikling af fostrets nyrer i livmoderen
English: No staining is observed or membrane staining is observed in < 10 % of the tumour cells
Danish: Der ses ingen farvning, eller membranfarvning ses i < 10 % af tumorcellerne.
English: HER2 over expression should be detected using an immunohistochemistry (IHC)-based assessment of fixed tumour blocks; HER2 gene amplification should be detected using in situ hybridisation using either SISH or FISH on fixed tumour blocks.
Danish: HER2-genamplifikation bør detekteres ved brug af in situ-hybridisering ved brug af enten SISH eller FISH på fikserede tumorblokke.
English: Single doses of trastuzumab alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with metastatic gastric cancer patients.
Danish: I et klinisk studie med patienter, der havde metastatisk ventrikelkræft, blev en vedligeholdelsesdosis på 10 mg/kg i 3-ugers intervaller efter en støddosis på 8 mg/kg undersøgt.
English: This yields a 7.4 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Danish: Resultatet er 7,4 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab med en pH på ca. 6,0.
English: • weakness
Danish: • svækkelse
English: Docetaxel was administered as follows: - intravenous docetaxel - 100 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 4 cycles (day 2 of first docetaxel cycle, then day 1 of each subsequent cycle).
Danish: Docetaxel blev administreret som følger: - intravenøs docetaxel - 100 mg/m2 som intravenøs infusion over 1 time, administreret hver 3. uge i
English: This yields a 21 mL solution for single-dose use, containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0.
Danish: Resultatet er 21 ml opløsning til enkeltdosisbrug, som indeholder ca. 21 mg/ml trastuzumab med en pH på ca. 6,0.
English: Tumour cell cluster with a strong complete, basolateral or lateral membranous reactivity irrespective of percentage of tumour cells stained
Danish: Tumorcellegruppe med en stærk komplet, basolateral eller lateral membranøs reaktivitet uden hensyntagen til procentdelen af farvede tumorceller
English: - The NSABP B-31 and NCCTG N9831 studies that comprise the joint analysis were designed to investigate the clinical utility of combining trastuzumab treatment with paclitaxel following AC chemotherapy; additionally, the NCCTG N9831 study also investigated adding trastuzumab sequentially to AC→P chemotherapy in patients with HER2 positive EBC following surgery.
Danish: - Studierne NSABP B-31 og NCCTG N9831, som udgør den samlede analyse, var designet til at undersøge den kliniske anvendelighed af at kombinere trastuzumab-behandling med paclitaxel efter AC-kemoterapi.
English: DO NOT SHAKE!
Danish: Brug ikke Ogivri:
English: - CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by - additional cycles of adjuvant trastuzumab (to complete 1 year of treatment) The efficacy results from Study MO16432 are summarized in Table 12.
Danish: - Paclitaxel 175 mg/m2, administreret hver 3. uge i 4 serier, som blev efterfulgt af - CMF på dag 1 og 8 hver 4. uge i 3 serier, som efter operation blev efterfulgt af - yderligere serier af adjuverende trastuzumab (indtil 1 års behandling var fuldført).
English: Tumour cell cluster with a faint ⁄ barely perceptible membranous reactivity irrespective of percentage of tumour cells stained
Danish: Tumorcellegruppe med en svag/ lige akkurat synlig membranøs reaktivitet uden hensyntagen til procentdelen af farvede tumorceller
English: Mylan Healthcare B.V. Tel: +31 (0)20 426 3300
Danish: Tel: +31 (0)20 426 3300
English: DFS Hazard ratios (95 % CI) p-value p < 0.0001
Danish: Sygdomsfri overlevelse risikoforhold (95 % konfidensinterval) p-værdi p < 0,0001
English: NAME OF THE MEDICINAL PRODUCT Ogivri 420 mg powder for concentrate for solution for infusion trastuzumab
Danish: Ogivri 420 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
English: Overall survival (death) - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Danish: Samlet overlevelse (død) - Antal patienter med en hændelse - Antal patienter uden en hændelse P-værdi versus observation Risikoforhold versus observation
English: Trastuzumab and anthracyclines should not be given concurrently in combination in the MBC setting.
Danish: Trastuzumab og antracykliner bør ikke anvendes i kombination hos patienter med metastatisk brystkræft.
English: Table 15 Population predicted steady state PK exposure values (median with 5th - 95th percentiles)for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Danish: Populationsforudsagte steady-state farmakokinetiske eksponeringsværdier (med 5.-95. percentiler) for trastuzumab intravenøse doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: Response rate (95 %CI)
Danish: Risikoforhold (95 % konfidensinterval)
English: Oxygen saturation decreased
Danish: +Nedsat iltmætning
English: Table 16 Population predicted PK parameter values at steady state for trastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Danish: Populationsforudsagte farmakokinetiske parameterværdier ved steady state for trastuzumab intravenøse doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft.
English: Ogivri 150 mg powder for concentrate for solution for infusion 15 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 150 mg of trastuzumab.
Danish: 15 ml klart type I hætteglas med butylgummiprop lamineret med en fluor-resin-film.
English: Baseline levels of the shed HER2-ECD observed in MGC patients were comparable to those in MBC and EBC patients and no apparent impact on trastuzumab clearance was observed.
Danish: Der blev observeret sammenlignelige baseline niveauer af shed HER2 ekstracellulære domæne hos patienter med metastatisk ventrikelkræft og patienter med henholdsvis metastatisk brystkræft og tidlig brystkræft.
English: • infection of lungs
Danish: • lungesygdomme
English: Table 14 Population predicted cycle 1 PK exposure values (median with 5th - 95th percentiles) fortrastuzumab intravenous dosing regimens in MBC, EBC and AGC patients
Danish: Populations-forudsagte farmakokinetiske eksponeringsværdier (median med 5.-95. percentiler) i serie 1 for trastuzumab intravenøse doseringsregimer hos patienter med metastatisk brystkræft, tidlig brystkræft og fremskreden ventrikelkræft.
English: NAME OF THE MEDICINAL PRODUCT Ogivri 150 mg powder for concentrate for solution for infusion trastuzumab
Danish: Ogivri 150 mg pulver til koncentrat til infusionsvæske, opløsning trastuzumab
English: Recurrence-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Danish: Tilbagefaldsfri overlevelse - Antal patienter med en hændelse - Antal patienter uden en hændelse P-værdi versus observation Risikoforhold versus observation
English: • skin rashes
Danish: • rygsmerter
English: Hazard Ratio versus AC→P (95 % CI)
Danish: Risikoforhold versus AC→P konfidensinte rval)
English: Bronchospasm
Danish: Lungesygdom
English: Distant disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Danish: Distant sygdomsfri overlevelse - Antal patienter med en hændelse - Antal patienter uden en hændelse P-værdi versus observation Risikoforhold versus observation
English: or - intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle).
Danish: 4 serier (dag 2 i første docetaxel-serie, derefter dag 1 i hver af de efterfølgende serier) eller - intravenøs docetaxel - 75 mg/m2 som intravenøs infusion over 1 time, administreret hver 3. uge i 6
English: or - intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days,
Danish: (aften på dag 1 til morgen på dag 15 i hver serie) eller - intravenøs 5-fluoruracil - 800 mg/m2/dag som en kontinuerlig intravenøs infusion over 5 dage, administreret hver 3. uge i 6 serier (dag 1 til 5 af hver serie).
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Ogivri Fortæl det altid til lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: • tremor
Danish: • kvalme
English: Ogivri vial
Danish: Lever og galdeveje
English: Disease-free survival - No. patients with event - No. patients without event P-value versus Observation Hazard Ratio versus Observation
Danish: Sygdomsfri overlevelse - Antal patienter med en hændelse - Antal patienter uden en hændelse P-værdi versus observation Risikoforhold versus observation
English: Gastrointestinal disorders Diarrhoea
Danish: Monoterapi Kombinationsterapi Trastuzumab
English: Disease-free survival No. patients with event (%)
Danish: Sygdomsfri overlevelse Antal patienter med en hændelse
English: Vomiting
Danish: Infektion
English: Papilloedema
Danish: Hæmorider
English: given every 3 weeks for 6 cycles (days 1 to 5 of each cycle) Either of which was administered with: - cisplatin - 80 mg/m2 every 3 weeks for 6 cycles on day 1 of each cycle.
Danish: - cisplatin - 80 mg/m2 hver 3. uge i 6 serier på dag 1 i hver serie.
English: Weight decreased/Weight loss
Danish: Virkning og anvendelse 2.
English: Onychoclasis
Danish: Vægttab
English: ATC vet code: QI07AD08.
Danish: ATCvet-kode: QI07AD08.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 04/07/2014.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 04/07/2014.
English: However, due to the low pathogenicity of this strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs.
Danish: På grund af denne stammes lave patogenitet er det ikke nødvendigt at holde vaccinerede hunde adskilt fra ikke-vaccinerede hunde.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/168/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/14/168/001
English: Overdose(symptoms, emergency procedures, antidotes):
Danish: Overdosis (symptomer, nødforanstaltninger, modgift):
English: The vaccine is intended for the active immunisation of healthy puppies and dogs against disease caused by canine parainfluenza virus.
Danish: Vaccinen er beregnet til aktiv immunisering af raske hvalpe og hunde mod sygdomme forårsaget af hundeparainfluenzavirus.
English: Duration of immunity: At least one year following the primary vaccination course.
Danish: Varighed af immunitet: Mindst et år efter basisvaccination.
English: 4.2 Indications for use, specifying the target species Active immunisation of dogs from 6 weeks of age:
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til aktiv immunisering af hunde fra 6-ugers alderen:
English: The contents of a single vial of Versican Plus Pi should be reconstituted with the contents of a single vial of Versiguard Rabies (instead of the solvent).
Danish: Indholdet af et enkelt hætteglas med Versican Plus Pi rekonstitueres med indholdet af et enkelt hætteglas med Versiguard Rabies (i stedet for med solvensen).
English: Onset of immunity: 3 weeks after completion of the primary course.
Danish: Indtræden af immunitet: 3 uger efter afsluttet basisvaccination.
English: If protection against Leptospira is required, dogs can be vaccinated with two doses of Versican Plus Pi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Danish: Hvis der ønskes beskyttelse mod leptospira, kan hunde vaccineres med to doser Versican Plus Pi blandet med Versican Plus L4 med 3 til 4 ugers mellemrum fra 6-ugers alderen: Indholdet af et enkelt hætteglas med Versican Plus Pi rekonstitueres med indholdet af et enkelt hætteglas med Versican Plus L4 (i stedet for med solvensen).
English: No other adverse reactions other than those mentioned under “Adverse reactions” were observed after administration of a 10-fold overdose of the vaccine.
Danish: Der er ikke observeret andre bivirkninger end dem, der er anført under ”Bivirkninger”, efter indgift af en tidobbelt overdosis af vaccinen.
English: First dose: Versican Plus Pi from 8-9 weeks of age.
Danish: 1. dosis: Versican Plus Pi fra 8-9-ugers alderen.
English: At least one year following the primary vaccination course.
Danish: Mindst et år efter basisvaccination.
English: 3 weeks after completion of the primary course.
Danish: 3 uger efter afsluttet basisvaccination.
English: Although the efficacy of the rabies fraction has been demonstrated following administration at 12 weeks, at the discretion of the veterinary surgeon, in case of need, dogs younger than 8 weeks can be vaccinated with Versican Plus Pi mixed with Versiguard Rabies as the safety of this association has been demonstrated in 6 week old dogs.
Danish: Selvom virkningen af rabiesfraktionen er påvist efter administration ved 12 ugers alderen, kan hunde, der er under 8 uger, vaccineres med Versican Plus Pi sammen med Versiguard Rabies, hvis dyrlægen skønner det nødvendigt, da sikkerheden af samtidig administration er påvist hos 6 uger gamle hunde.
English: Solve nt: Water for injections (Aqua ad iniectabilia)
Danish: Solve ns: Vand til injektionsvæsker (Aqua ad iniectabilia)
English: Second dose: Versican Plus Pi mixed with Versiguard Rabies 3-4 weeks later, but not before 12 weeks of age.
Danish: 2. dosis: Versican Plus Pi blandet med Versiguard Rabies 3-4 uger senere men ikke tidligere end 12ugers alderen.
English: Re-vaccination scheme: A single dose of Versican Plus Pi to be given annually.
Danish: Revaccinationsprogram: Der anbefales en årlig vaccination med en enkelt dosis Versican Plus Pi.
English: Reconstituted vaccine: whitish to yellowish colour with a slight opalescence.
Danish: Rekonstitueret vaccine: Hvidlig eller gullig farve med let opalisering.
English: Type 1 glass vial containing 1 ml of solvent closed with a chlorobutyl rubber stopper and aluminium cap.
Danish: Hætteglas type I, der indeholder 1 ml solvens, lukket med en prop af chlorbutylgummi og et aluminiumlåg.
English: Aseptically reconstitute the lyophilisate with the solvent.
Danish: Rekonstituer lyofilisatet med solvensen aseptisk.
English: Primary vaccination scheme: Two doses of Versican Plus Pi 3-4 weeks apart from 6 weeks of age.
Danish: Basisvaccination: To doser af Versican Plus Pi med 3 til 4 ugers mellemrum fra 6-ugers alderen.
English: Type I glass vial containing 1 dose of lyophilisate closed with a bromobutyl rubber stopper and aluminium cap.
Danish: Hætteglas type I, der indeholder 1 dosis lyofilisat, lukket med en prop af brombutylgummi og et aluminiumlåg.
English: Incompatibilities: Do not mix with any other veterinary medicinal product other than those mentioned above.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette lægemiddel ikke blandes med andre lægemidler end dem der er anført ovenfor.
English: ADVICE ON CORRECT ADMINISTRATION Aseptically reconstitute the lyophilisate with the solvent.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Rekonstituer lyofilisatet med solvensen aseptisk.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi lyophilisate and solvent for suspension for injection for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi lyofilisat og solvens til injektionsvæske, suspension til hund
English: PACKAGE LEAFLET: Versican Plus Pi lyophilisate and solvent for suspension for injection for dogs
Danish: INDLÆGSSEDDEL Versican Plus Pi lyofilisat og solvens til injektionsvæske, suspension til hund
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
Danish: LÆGEMIDDELFORM Lyofilisat og solvens til injektionsvæske, suspension.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi lyophilisate for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi - lyofilisat til hund
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Pi solvent for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Versican Plus Pi - solvens til hund
English: 4.1 Target species
Danish: 4.1 Dyrearter, som lægemidlet er beregnet til Hund
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No other adverse reactions other than those mentioned in section 4.6 were observed after administration of a 10-fold overdose of the vaccine.
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG
English: This procedure will involve removing the following recommendations and indications for which no data were provided:
Danish: Denne procedure vil omfatte fjernelse af følgende anbefalinger og indikationer, for hvilke der ikke blev fremsendt data:
English: In practice this means that in intensive systems all the birds in one house will be treated even though not all are exhibiting signs of disease.
Danish: I praksis betyder dette, at alle fuglene i intensive systemer i et hus vil blive behandlet, selv om ikke alle viser tegn på sygdom.
English: o repeat treatment can be administered after 5 days if infection is severe;
Danish: o behandlingen kan gentages efter 5 dage, hvis der er tale om en alvorlig infektion;
English: o prevention and control of coccidiosis;
Danish: o forebyggelse og kontrol af coccidiose;
English: o use in pigeons.
Danish: o brug hos duer.
English: However, it was noted that the indications, species and posology in the SPCs of some of the authorised products were different and these therefore need to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Danish: Det blev dog bemærket, at indikationerne, arterne og doseringsanvisningen i produktresuméet for nogle af de godkendte produkter var forskellige, og de skulle derfor ændres for at bringe dem i overensstemmelse med de indikationer og doseringsanvisninger, der blev anvendt i miljørisikovurderingen.
English: The dose and duration of treatment in all Member States for chickens and turkeys is 7 mg/kg bodyweight per day for two consecutive days.
Danish: Den anbefalede dosis og behandlingsvarighed for høns og kalkuner er 7 mg/kg kropsvægt dagligt i to på hinanden følgende dage.
English: Cevazuril1
Danish: Side 2/2
English: Toltrazuril is administered orally in the drinking water for the treatment of coccidiosis.
Danish: Toltrazuril er et triazintrionderivat, der indgives oralt i drikkevandet til behandling af coccidiose hos høns og kalkuner.
English: Critical evaluation
Danish: BAGGRUNDSOPLYSNINGER
English: It was therefore concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided the product is used as indicated by the Marketing Authorisation Holders in their responses to questions by the Committee, i.e. a dose of 7 mg/kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
Danish: CVMP konkluderede, at markedsføringstilladelserne kan opretholdes uden særlige advarsler i afsnit 5.3 (Miljøoplysninger) i produktresuméet, forudsat at produktet anvendes under de godkendte forhold, dvs. en dosis på 7 mg/kg kropsvægt i to på hinanden følgende dage til behandling af coccidiose hos høns og kalkuner.
English: Animal Health
Danish: UDVALGET FOR VETERINÆRLÆGEMIDLER (CVMP)
English: Germany considered that the authorisation of Baycox 2.5 % solution may present a potential serious risk to the environment on the following grounds:
Danish: Tyskland indbragte spørgsmålet for CVMP på grund af betænkeligheder ved, at toltrazuril kan udgøre en alvorlig risiko for miljøet af følgende grunde:
English: 2794-003 Carnaxide
Danish: EMEA/402698/2008-DA