natgillin/translations-raw huggingface dataset:
Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre 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 reaction(s) 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).
EU/2/04/050/001 Lyofilisat (10 flasker à 1 dosis) + solvens (10 flasker à 1 ml) EU/2/04/050/002 Lyofilisat (50 flasker à 1 dosis) + solvens (50 flasker à 1 ml)
EU/2/04/050/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/050/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Lyofilisat (10xdosis) + solvens (10x1 ml) Lyofilisat (50x1 dosis) + solvens (50x1 ml)
Lyophilisate (10xdose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Type I glasflaske indeholdende 1 dosis af lyofilisat og type I glasflaske indeholdende 1 ml solvens, begge lukket med en butyl elastomer prop og forseglet med en aluminiums- eller plastkapsel.
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium or plastic cap.
− anden injektion: 3-4 uger senere.
Primary vaccination course: - first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later.
2 æg infektiøs dosis 50%.
2 egg infective dose 50%
Hvis selv-injektion opstår ved et uheld, bør der øjeblikkeligt søges læge og lægen informeres om, at selv-injektion med en levende chlamydia vaccine er sket.
If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
Ved mistanke om tilstedeværelse af høje værdier af maternelle antistoffer over for rhinotracheitis, calicivirus, panleukopeni eller Chlamydophila komponenterne (fx hos 9-12 uger gamle killinger født af hunkatte, der var vaccineret før drægtighed og/eller ved kendskab til eller mistanke om, at moderdyret har været udsat for de pågældende patogener), bør basisvaccination udsættes til killingerne er 12 uger gamle.
Where high levels of maternal antibodies against rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
1 cellekultur infektiøs dosis 50%.
1 cell culture infective dose 50%
Der foreligger oplysninger om sikkerhed og virkning, der viser, at denne vaccine kan blandes og gives med Merials vaccine uden adjuvans mod felin leukæmi og/eller anvendes den samme dag men ikke blandes med Merials vaccine med adjuvans mod rabies.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Varigheden af immunitet efter sidste revaccination er 3 år for rhinotracheitis, calicivirus og panleukopeni komponenterne og 1 år for Chlamydophila felis komponenten.
The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the Chlamydophila felis component.
Gentamycin max.............................................................................................................................. 28 µg Solvens:
Gentamicin, at most .......................................................................................................................... 28 µg Solvent:
Uforligeligheder: Må ikke blandes med Merials vaccine med adjuvans mod rabies.
Incompatibilities : Do not mix with Merial adjuvanted vaccine against rabies.
Purevax RCPCh solvens.
Purevax RCPCh solvent
FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
− efterfølgende revaccinationer skal foretages: hvert år for chlamydiose komponenten og med intervaller på op til tre år for rhinotracheitis, calicivirus og panleukopeni komponenterne.
Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the chlamydiosis component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... ≥ 104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ....................................... ≥ 2,0 ELISA U. Svækket Chlamydophila felis (905 stamme) ....................................................................... ≥ 103,0 EID502 Svækket felin panleukopeni virus (PLI IV) ...................................................................... ≥ 103,5 CCID501
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
1 dosis (1 ml) indeholder: FHV (F2 stamme) ............................................................................................................... ≥ 104,9 CCID50
Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... ≥ 104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ...................................... ≥ 2,0 ELISA U. Svækket Chlamydophila felis (905 stamme) ....................................................................... ≥ 103,0 EID502 Svækket felin panleukopeni virus (PLI IV) ...................................................................... ≥ 103,5 CCID501
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Vaccine mod felin viral rhinotracheitis, felin calicivirus, chlamydiose og felin panleukopeni Stimulerer aktivt immuniteten over for felin rhinotracheitis herpesvirus, felin calicivirus, Chlamydophila felis og felin panleukopeni virus.
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis and feline panleucopenia virus.
Det er vist, at immuniteten indtræder 1 uge efter basisvaccination for rhinotracheitis, calicivirus, Chlamydophila felis og panleukopeni.
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components.
Revaccination:
Pregnancy and lactation:
Purevax RCPCh Lyofilisat og solvens til injektionsvæske, suspension.
Purevax RCPCh Lyophilisate and solvent for suspension for injection.
Dinatriumhydrogenorthophosphat
Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous
Purevax RCPCh lyofilisat og solvens til injektionsvæske, suspension.
Purevax RCPCh lyophilisate and solvent for suspension for injection
Gentamycin max............................................................................................................................... 28 µg
Gentamicin, at most .......................................................................................................................... 28 µg
Purevax RCPCh, lyofilisat og solvens til injektionsvæske, suspension.
PACKAGE LEAFLET FOR: Purevax RCPCh lyophilisate and solvent for suspension for injection
EFSA-dokumentet anfører dog også følgende:
However, the same EFSA document also states that:
Derfor er denne indikation blevet fjernet.
Therefore this indication was removed.
ATCvet-kode: QA07AA92.
ATCvet code: QA07AA92.
En sygdom skal medtages på listen, hvis den er blevet vurderet i overensstemmelse med artikel 7.
A disease shall be included on the list if it has been assessed in accordance with Article 7.
Medlemssta t EU/EEA
Member State EU/EEA
Dette er nævnt i forordning (EF) nr. 2160/20039 og baseret på EFSA's udtalelse (2004)11.
This is stated in the Regulation (EC) No 2160/20039 and based on the EFSA Opinion (2004)11.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 g indeholder:
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g contains:
100% v/v
100% w/w
hos fjerkræ generelt ikke megen berettigelse.
in poultry has little justification.
Drikkesystemer bør være rengjorte og rustfrie for at undgå nedsat aktivitet.
Drinking systems should be clean and free of rust to avoid reduction of activity.
Disse foranstaltninger kan f.eks. omfatte forbud mod og begrænsninger af anvendelse af veterinærlægemidler.
Those measures may cover, for example, prohibitions and restrictions on the use of veterinary medicinal products.
Dyrets vægt skal bestemmes så præcist som muligt for at undgå underdosering.
The weight of the animals should be determined as accurately as possible to avoid underdose.
Derudover er opbevaringstiden blevet reduceret til 18 måneder.
Additionally, the shelf life has been reduced to 18 months.
Der er ikke fremlagt accelererede data under indbringelsesproceduren.
No accelerated data have been provided during the referral procedure.
FREMSTILLERENS BATCHNUMMER Lot:
MANUFACTURER'S BATCH NUMBER Lot:
Der skal tages hensyn til den officielle, nationale og regionale antibiotikapolitik, når veterinærlægemidlet anvendes.
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Gennemsnitligt dagligt vandindtag (l/dyr)
Average daily water intake (l/animal)
Derudover var det i nogle medlemsstater tilladt at anvende en måleanordning ved administration af Girolan.
Additionally, in some Member States a measuring device was authorised for the administration of Girolan.
Dette fravær af forholdsregler vedrørende opbevaring af produktet er baseret på historiske data og var allerede godkendt i de enkelte medlemsstater inden indbringelsen.
This lack of storage precautions for the product is based on historical data, and was already approved in the individual Member States prior to the referral.
Alle kalvene gennemgik dagligt en fuld klinisk vurdering i mindst den første uge af hver undersøgelse.
All calves were subjected to a full clinical examination daily for at least the first week of each trial.
Reduceret dødelighed var det primære effektkriterium.
Mortality was the principal criteria for efficacy.
Harmoniseringen af tilbageholdelsestiderne var baseret på de undersøgelser, der var udført bedst og mest pålideligt.
The harmonisation of withdrawal periods was based on the better conducted and most reliable studies.
Det medicinerede vand bør være den eneste tilgængelige vandkilde.
Medicated water should be the only source of drinking.
og Campylobacter spp.
and Campylobacter spp.
Europa-Kommissionen skal desuden vedtage delegerede retsakter vedrørende ændringer i den omtalte liste.
Furthermore, the European Commission shall adopt delegated acts concerning amendments to the list referred.
Vurderingen fokuserer på de punkter vedrørende harmoniseringen, som kan ændre benefit/risk-forholdet.
This evaluation focuses on issues with regard to the harmonisation that may change the benefit-risk balance.
Den anbefale dosis må ikke overskrides.
Do not exceed the recommended dose.
I den forbindelse skal Europa-Kommissionen desuden vedtage delegerede retsakter i henhold til artikel 264 vedrørende ændringer i den omtalte liste.
Furthermore, in this sense, the European Commission shall adopt delegated acts in accordance with Article 264 concerning amendments to the list referred.
• Indikationerne begrænses til de indikationer, der er tilstrækkeligt underbygget af effektdata.
• The restriction of the indications to those that are adequately substantiated by efficacy data;
Dosis/respons-forholdet blev observeret specifikt, hvad angår dødelighed.
Dose/response was clearly observed for the mortality rate.
Polígono Industrial de Alcobendas 28108 Alcobendas (Madrid)
de la Industria, nº 30 Polígono Industrial de Alcobendas 28108 Alcobendas (Madrid)
Zoonotisk Salmonella står på forordningens liste.
Zoonotic Salmonella is listed in this Regulation.
Undersøgelsen var gennemført i henhold til god klinisk praksis.
The study was conducted under the principles of Good Clinical Practice.
Hævelser i ansigt, læber og øjne eller vejrtrækningsvanskeligheder er mere alvorlige symptomer og kræver akut lægehjælp.
Swelling of the face, lips and eyes or difficult breathing are more serious symptoms and require urgent medical assistance.
Overlevende kalve i den ubehandlede kontrolgruppe tog ikke på i vægt i 12-dages perioden, mens overlevende kalve i de behandlede grupper udviste signifikante stigninger i den gennemsnitlige daglige vægtforøgelse.
Surviving calves in the untreated control group failed to gain weight in the twelve days period whereas the survivors in the treated groups showed significant increases in average daily weight gain.
Da dosisregimerne og indikationerne ikke er blevet udvidet, er der dog ingen stigning i miljøets eksponering for det aktive stof.
However, as the dosing regimens and indications have not been extended, there is no increase in the exposure of the environment to the active substance.
MIC90-værdien var 8 μg/ml eller mindre.
MIC90 was 8 μg/ml or less.
I den sammenhæng bør der tages hensyn til, at produktets effekt blev understøttet af en række undersøgelser, hvor veterinærlægemidlet blev administreret som behandling og ikke som forebyggelse.
In this sense, it should be taken into account that the efficacy of the product was supported by various studies, where the veterinary medicinal product was administered for treatment and not for prevention.
Farmakoterapeutisk gruppe: intestinale antiinfectiva, antibiotika.
Pharmacotherapeutic group: Intestinal antiinfectives, antibiotics.
Samlet resumé af den videnskabelige vurdering af Girolan og det relaterede navn Apralan (se bilag I)
Overall summary of the scientific evaluation of Girolan and its associated name Apralan (see Annex I)
Derfor vurderer CVMP, at den anførte indikation er berettiget.
Therefore, the CVMP concluded that the proposed indication was justified.
For at sikre den rette dosis skal koncentrationen af veterinærlægemidlet tilpasses tilsvarende.
In order to obtain the correct dose, the concentration of the veterinary medicinal product has to be adjusted accordingly.
Opløsninger i mælk og mælkeerstatninger skal tilberedes umiddelbart før anvendelse.
Solutions in milk and reconstituted milk replacer should be prepared immediately before use.
I den forbindelse skal det bemærkes, at colibacillose hos kyllinger hovedsageligt er en systemisk infektion, der omfatter flere organer, og at den primære indgangsvej er åndedrætssystemet.
In this respect, it is to be noted that colibacillosis in chickens is essentially a systemic infection, involving a variety of organs, and its main entry route is the respiratory system.
Det anbefales derfor at tage højde for dette ved bedøvelse af behandlede dyr.
It is therefore recommended to take such an effect into account when anaesthetising treated animals.
Produktet kan forårsage irritation eller sensibilisering ved hud- eller øjenkontakt eller inhalation.
This product may cause irritation or sensitisation after skin or eye contact or inhalation.
I tilfælde af øjenkontakt skylles området med rigeligt vand.
In case of eye contact, rinse the affected area with plenty of water.
Optagelse: Optagelsen kan være høj hos nyfødte dyr men aftager hurtigt i løbet af de første leveuger.
Absorption: Absorption may be high in new-born animals but rapidly decreases in the first weeks of life.
• Der blev ikke identificeret specifikke fordele ved anvendelse af antimikrobielle stoffer i kødproducerende besætninger.
• No specific advantages were identified for the use of antimicrobials in the case of meat-producing flocks.
Ved anvendelse i ekstraordinære tilfælde af hensyn til dyresundheden og dyrevelfærden skal der tages højde for konsekvenserne for folkesundheden.
Any use in exceptional circumstances on animal health and welfare grounds must recognize the consequences for public health.
DK-2730 Herlev
DK-2730 Herlev Denmark
Udfyldes nationalt.
To be completed nationally.
Der blev ikke fremlagt data for Salmonella pullorum.
No data were presented for Salmonella Pullorum.
Hvis dette ikke er muligt, bør behandlingen baseres på lokale (regionale, besætningsniveau) epidemiologiske informationer om følsomheden af bakterien.
If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Selvom åndedrætssystemet vurderes at være en væsentlig indgangsvej, forventes antimikrobielle stoffer at virke på infektionsstedet.
Although the respiratory route is considered a significant mode of entry, antimicrobials are expected to act at the site of infection.
Denne benefit/risk-vurdering finder sted inden for rammerne af artikel 34 i direktiv 2001/82/EF og har i denne procedure til formål at harmonisere godkendelsesbetingelserne i EU for veterinærlægemidlet Girolan.
This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the veterinary medicinal product Girolan.
Hvad angår Salmonella, blev der gennemført yderligere 27 undersøgelser af kalve, hvoraf 15 var terapeutiske og 12 profylaktiske.
With regard to Salmonella, a series of twenty-seven further experiments were conducted in calves, 15 of which therapeutic and 12 prophylactic.
• Den harmoniserede produktinformation for Girolan indeholder de nødvendige oplysninger til at sikre risikofri og effektiv anvendelse af lægemidlet.
• The harmonised product information of Girolan contains the necessary information to ensure the safe and effective use of the product.
Breve er pakket i kartoner indeholdende 50 breve.
Sachets are packed in cardboard boxes containing 50 sachets.
Der blev fremlagt en nyligt gennemført central klinisk feltundersøgelse.
A pivotal recently-conducted clinical field trial was provided.
Desuden vurderes anvendelse af apramycin at være at foretrække frem for potentiel anvendelse af mere kritiske antimikrobielle stoffer som f.eks. fluoroquinoloner.
In addition use of apramycin was considered preferable to the potential use of more critical antimicrobials such as fluoroquinolones.
I alle undersøgelserne blev dyrene vurderet for at bekræfte diagnosen inden behandlingens påbegyndelse.
In all trials, the animals were examined to confirm the diagnosis prior of to the initiation of treatment.
CVMP's afgav den 5. oktober 2017 en udtalelse vedrørende denne indbringelsesprocedure, og indehaverne af markedsføringstilladelse har anmodet om revurdering af CVMP's udtalelse.
Following the CVMP opinion of 5 October 2017 on this referral procedure, the marketing authorisation holders requested a re-examination of the CVMP opinion.
Alvorligt syge dyr, der ikke kan drikke, bør gives passende parenteral behandling.
Animals with acute or severe clinical conditions that cannot drink, should receive adequate parenteral treatment.
Revurderingen omfattede produktets opbevaringstid inden anbrud, der blev nedsat fra 3 år til 18 måneder.
The scope of the re-examination was the shelf life of the product prior to first opening which was reduced from 3 years to 18 months.
Testtidspunkterne for disse batcher stemmer ikke alle overens med de gældende retningslinjer, men i alle tilfælde fremlægges der data for mindst 5 tidspunkter i løbet af stabilitetsundersøgelsen, og det er derfor muligt at følge datatendenserne.
The testing timepoints for these batches are not all in accordance with current guidelines but in all cases, data is provided for at last 5 time-points over the course of the stability study and trending of data is therefore possible.
Der blev fremlagt data for 36 måneder vedrørende 3 batcher af færdigt produkt i de endelige beholdere (flasker, poser og breve i to forskellige størrelser).
Data for 36 months was presented for 3 batches of finished product packaged in the final containers (bottles, bags and two different size sachets).
Liste over navne, lægemiddelform, veterinærlægemidlets styrke, dyrearter, indgivelsesvej, indehavere af markedsføringstilladelser i medlemslandene
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holders in the Member States
CVMP accepterede sletningen af Salmonella.
The CVMP accepted this deletion of Salmonella.
Selvom det er anerkendt, at Salmonella Dublin er en ikke-almindelig årsag til salmonellose hos mennesker, kan der være tale om svære infektioner.
Although it is acknowledged that Salmonella Dublin is an uncommon cause of salmonellosis in man, infection can be severe.
Det skal bemærkes, at Girolan i nogle medlemsstater også var godkendt til anvendelse mod Salmonella hos svin, men indehaveren af markedsføringstilladelse besluttede at fjerne denne indikation, da den ikke var tilstrækkeligt dokumenteret.
It should be noted that in some Member States Girolan was also authorised for use against Salmonella in pigs, however the marketing authorisation holder decided to remove this indication, as it could not be supported.
Behandlingsforløbet blev påbegyndt to uger efter fravænning, da tegnene på colibacillose var tydeligt til stede.
The treatment period was initiated two weeks after weaning, when the signs of colibacillosis were clearly established.
Heller ikke her var der fremlagt data for Salmonella gallinarum, og på den baggrund blev denne indikation ikke overvejet yderligere.
Again, no data for Salmonella Gallinarum was presented and in view of this it was not considered further for this indication.
Dette blev ikke vurderet acceptabelt, da det aktive stofs styrke bør udtrykkes i IE/g produkt, idet analyseresultatet bestemmes ved hjælp af en mikrobiologisk metode.
This was not considered acceptable, as the active substance strength should be expressed in IU/g product, since the assay is determined by means of a microbiological method.
Disse data er konsistente med den publicerede litteratur.
These data are consistent with the published literature.
Aminoglykosider er anført på WHO's liste (2017)14 som kritisk vigtige til behandling af visse zoonotiske infektioner hos mennesker (f.eks. Enterococcusinfektioner).
Aminoglycosides are listed by WHO (2017)14 as critically important for the treatment of certain zoonotic infections in humans (such as Enterococcus infections).
Blokbundet lamineret papirpose lukket af trykforseglede kæber.
Block bottomed laminated paper bag closed by pressurized heat-sealing jaws.