natgillin/translations-raw huggingface dataset:
(4- hydroxybenzoat) / propyl (4- hydroxybenzoat) = E 218 / E216, smagsstof, natriumacetat, eddikesyre, renset vand.
methyl (4-hydroxybenzoate) / propyl (4-hydroxybenzoate) = E 218 / E 216, flavouring agent, sodium acetate, acetic acid, purified water.
- 10 ml Zyrtec oral opløsning (=2 måleskeer) indeholder:
- 10 ml Zyrtec oral solution (=2 measuring spoons) contain:
Sorbitol (svarende til 3, 15 g glucose).
3.15 g glucose equivalents (sorbitol).
Zyrtec s udseende og pakningstørrelse Klar og farveløs væske med let sød smag og bananaroma.
What Zyrtec looks like and contents of the pack
Zyrtec 1mg/ ml – orale Lösung Belgien:
Zyrtec 1 mg/ ml – orale Lösung Belgium:
Zyrtec saft Ungarn:
Zyrtec saft Hungary:
Zyrtec oldat Irland:
Zyrtec oldat Ireland:
Zirtek oral solution 1 mg/ ml Italien:
Zirtek oral solution 1mg/ ml Italy:
Zirtec 1 mg/ ml soluzione orale Letland:
Zirtec 1mg/ ml soluzione orale Latvia:
Zyrtec Norge:
Zyrtec Norway:
Zyrtec Polen:
Zyrtec Poland:
Virlix, Zyrtec Portugal:
Virlix, Zyrtec Portugal:
Zyrtec, Virlix Slovenien:
Zyrtec, Virlix Slovenia:
Zyrtec 1mg/ ml peroralna raztopina Spanien:
Zyrtec1 mg/ ml peroralna raztopina Spain:
Alerlisin, Virlix, Reactine 5mg/ 5ml solución oral, Zyrtec solución oral Sverige:
Alerlisin, Virlix, Reactine 5mg/ 5ml solución oral, Zyrtec solución oral Sweden:
Zyrlex England:
Zyrlex United Kingdom:
87
92
London, den 6. oktober 2008 Dok. ref.
Ref.
EMEA/ CHMP/ 541618/ 2008
EMEA/ CHMP/ 541853/ 2008
UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 30 OM Zyrtec og tilknyttede navne
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Zyrtec and associated names
Internationalt fællesnavn (INN): cetirizin
International Non-Proprietary Name (INN): cetirizine
Zyrtec og tilknyttede navne, 10 mg filmovertrukne tabletter, 10 mg/ ml orale dråber, 1 mg/ ml oral opløsning, er et lægemiddel mod allergi til lindring af næse - og øjensymptomer på sæsonbetinget og tilbagevendende allergisk rhinitis og til lindring af kronisk idiopatisk urticaria.
Zyrtec and associated names, 10 mg film coated tablets, 10 mg/ ml oral drops, 1 mg/ ml oral solution, is an anti-allergic drug indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of chronic idiopathic urticaria.
Den 9. oktober 2007 indbragte Kommissionen en sag for EMEA i henhold til artikel 30 i direktiv 2001/ 83/ EF, med senere ændringer, med henblik på harmonisering af de nationalt godkendte produktresuméer, etikettering og indlægsseddel for lægemidlet Zyrtec og tilknyttede navne.
On 9 October 2007 the Commission presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Zyrtec and associated names.
Grundlaget for indbringelsen af sagen var, at der var afvigelser mellem de produktresuméer, der var godkendt for Zyrtec og tilknyttede navne i EU- medlemsstaterne, især med hensyn til indikationer, dosering, kontraindikationer og særlige advarsler.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Zyrtec and associated names approved across EU Member States, in particular with respect to the indications, the posology, the contra-indications and the special warnings.
Europa- Kommissionen traf en afgørelse den 6. oktober 2008.
A Decision was issued by the European Commission on 6 October 2008.
PRODUKTRESUME
SUMMARY OF PRODUCT CHARACTERISTICS OF THE REFERENCE MEMBER STATE
1/ 4 1.
1/ 5 1.
VETERINÆRLÆGEMIDLETS NAVN
NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT
AVINEW
AVINEW
Levende Newcastle disease virus, VG/ GA stamme, min.............................................. 5, 5 log10 EID50 Excipient................................................................................................................................. q. s.
Live Newcastle disease virus, VG/ GA strain, at least Excipient
Frysetørret vaccine til opløsning i dertil egnet opløsning (klorfrit drikkevand).
Freeze-dried vaccine to be diluted in appropriate diluent (non chlorinated drinking water).
Vaccinen indeholder levende Newcastle disease virus, VG/ GA stamme.
The vaccine contains live Newcastle disease virus, VG/ GA strain.
VG/ GA stammen er lentogen og naturlig apatogen for kyllinger.
The VG/ GA strain is lentogenic and naturally apathogenic for chickens.
5. 0 Dyrearter, som lægemidlet er beregnet til
5.0 Target species
5. 1 Terapeutiske indikationer
5.1 Indications for use, specifying the target species
Til daggamle kyllinger:
In chickens from the age of one day:
Aktiv immunisering over for Newcastle disease for at reducere dødelighed og kliniske symptomer i tilslutning til sygdommen.
Active immunisation against Newcastle disease to reduce mortality and clinical signs associated with the disease.
Varighed af immunitet i henhold til vaccinationsskemaet beskrevet under 5. 7: beskyttelse indtil 6 - ugers alderen.
Duration of immunity induced by the vaccination scheme described under 5.7: protection until the age of 6 weeks.
5. 2 Kontraindikationer
5.2 Contraindications and warnings in respect of other products used in the host, immunological status of host and physiological status of host
5. 3 Bivirkninger
5.3 Undesirable effects in the target species (frequency and seriousness)
5. 4 Særlige forsigtighedsregler vedrørende brugen
5.4 Special precautions for use
Vacciner kun raske dyr.
Vaccinate healthy birds only.
5. 5 Anvendelse under drægtighed og laktation
2/ 5 5.5 Use during pregnancy and lactation
Bør ikke anvendes til æglæggende fugle.
Vaccination of chickens in lay is not recommended.
2/ 4 5. 6 Interaktion med andre lægemidler og andre former for interaktion
5.6 Interaction with other vaccines and medicaments when administered in combination with the product
Ingen information er tilgængelig om sikkerhed og effekt ved samtidig anvendelse med en anden vaccine.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
5. 7 Dosering og indgivelsesmåde
5.7 Posology and method of administration
Basisvaccination ved okulær rute (administration som øjendråbe) eller okulo- nasal rute (tyk sprøjte administration): daggamle kyllinger Boostervaccination ved oral rute (administration via drikkevand):
Primary vaccination by ocular route (eye drop application) or oculo-nasal route (coarse spray application): from the age of one day.
2- 3 uger gamle Det mindste interval mellem de to vaccinationer bør være 2 uger.
Booster vaccinations by oral route (drinking water application): at the age of 2 to 3 weeks.
Til fremstilling og administration af vaccinen, skal anvendes sterilt materiale fri for desinficerende og/ eller antiseptisk middel.
For the preparation and administration of the vaccine, use sterile material free from disinfectant and/ or antiseptic.
− Individuel vaccination: okulær rute Til 1000 fugle opløses den frysetørrede pille, sv. t.
- Individual vaccination: ocular route
1000 doser, i 3- 5 ml klorfrit drikkevand, der derefter opløses i 50 ml klorfrit drikkevand.
For 1,000 birds, reconstitute the lyophilisate pellet corresponding to 1,000 doses into 3 to 5 ml of non chlorinated drinking water and subsequently dilute it into 50 ml of non chlorinated drinking water.
− Massevaccination: oral rute Til 1000 fugle opløses den frysetørrede pille, sv. t.
- Mass vaccination: oral route
1000 doser, i 3- 5 ml klorfrit drikkevand, der derefter opløses i den mængde klorfrit drikkevand, der optages inden for 1- 2 timer.
For 1,000 birds, reconstitute the lyophilisate pellet corresponding to 1,000 doses into 3 to 5 ml of non chlorinated drinking water and subsequently dilute it into the volume of non chlorinated drinking water to be consumed within one to two hours.
Når der anvendes vand fra hovedledningen, skal al vand der kommer i kontakt med vaccinen behandles med skummetmælkspulver i en mængde på 2, 5 g/ l for at neutralisere spor af klor.
When using mains water, treat all water to come into contact with the vaccine with skimmed milk powder at a rate of 2.5 g per litre in order to neutralise traces of chlorine.
− Massevaccination: respiratorisk rute Til 1000 fugle opløses den frysetørrede pille, sv. t.
- Mass vaccination: respiratory route
1000 doser, i 3- 5 ml klorfrit drikkevand, der derefter opløses i den mængde klorfrit drikkevand, der svarer til den type sprøjte der anvendes (tryksprøjte eller sprøjte med rotationskegle).
For 1,000 birds, reconstitute the lyophilisate pellet corresponding to 1,000 doses into 3 to 5 ml of non chlorinated drinking water and subsequently dilute it into the volume of non chlorinated drinking water according to the type of sprayer used (pressure-sprayer or sprayer with rotary cone).
Vaccineopløsningen sprøjtes ud over fuglene, idet der anvendes en sprøjte der kan producere microdråber (gennemsnitlig diameter 80- 100 µm).
Spray the vaccine solution above the birds using a spray capable of producing micro-droplets (mean diameter 80-100 µm).
5. 8 Overdosering
5.8 Overdose (signs, emergency procedures, antidotes) (if necessary)
5. 9 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
3/ 5 5.9 Special warnings for each target species
3/ 4 5. 10 Tilbageholdelsestid
5.10 Withdrawal periods
5. 11 Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr
5.11 Special precautions to be taken by the person administering the product to animals
6. 1 Uforligeligheder
6.1 Incompatibilities (major)
Tilstedeværelsen af desinficerende og/ eller antiseptisk middel i vand og materiale, der anvendes til fremstilling af vaccineopløsningen, er ikke forenelig med en effektiv vaccination.
The presence of disinfectant and/ or antiseptic in water and material used for the preparation of vaccine solution is not compatible with an effective vaccination.
6. 2 Opbevaringstid
6.2 Shelf-life
2 timer.
2 hours.
6. 3 Særlige opbevaringsforhold
6.3 Special precautions for storage
6. 4 Emballage (art og indhold)
6.4 Nature and contents of container
− Type I glasflaske Butyl elastomer prop Aluminiumshætte
Butyl elastomer closure Aluminium cap
− Æske med 1 flaske à 1000 doser.
- Box of one 1,000-dose bottle
Æske med 1 flaske à 2000 doser.
ADDITIONAL INFORMATION
Æske med 10 flasker à 1000 doser.
Marketing Authorisation number:
Æske med 10 flasker à 2000- doser.
subject to medical prescription
6. 5 Navn og adresse på indehaveren af markedsføringstilladelsen
5/ 5
LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ OG INDEHAVER AF MARKEDSFØRINGSTILLADELSE
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
1/ 12 Medlemsstat
1/ 12 Member State Applicant
Ansøger eller indehaver af markedsføringstilladelse
or
Produktets særnavn
Marketing Product
Lægemiddelfor m
Pharmaceutical Strength
Styrke
Animal
Dyreart
species
Doseringshyppighed Anbefalet dosis og indgivelsesvej
of administration
Intervet Deutschland GmbH Feldstrasse 1a DE- 85716 Unterschleissheim
Intervet Deutschland GmbH Feldstrasse 1a DE-85716 Unterschleissheim Germany Tel: +49 (89) 310 062 59 Fax: +49 (89) 310 03 27
Én dosis a 2 ml Kvæg indeholder:
Per 2 ml dose:
50 ELISA -
50 ELISA units, inducing ≥ 4.6 log2 VN units
Intramuskulær injektion
Intramuscular injection.
Intervet Belgium Bedrijvenlaan 7 B- 2800 Mechelen Belgien Tel: +32 (15) 436 728 Fax: +32 (15) 436 733
Intervet Belgium Bedrijvenlaan 7 B-2800 Mechelen Belgium Tel: +32 (15) 436 728 Fax: +32 (15) 436 733
Som ovennævnte Som ovennævnte
As above
Som Som ovennævnte ovennævnte
As above
Som ovennævnte
As above
Intervet Bulgaria EOOD 7, Iskarsko shoes blvd BG- 1528 Sofia Bulgarien Tel: +359 (2) 970 1070 Fax: +359 (2) 971 0900
Intervet Bulgaria EOOD 7, Iskarsko shoes blvd BG-1528 Sofia Bulgaria Tel: +359 (2) 970 1070 Fax: +359 (2) 971 0900
Som Som ovennævnte ovennævnte
As above As above As above As above
Medivet Suppliers Ltd 87c Aglandjias Avenue PO Box 20932 CY- 1665 Nicosia Cypern Tel: +357 223 366 05 Fax: +357 223 366 07
Medivet Suppliers Ltd 87c Aglandjias Avenue PO Box 20932 CY-1665 Nicosia Cyprus Tel: +357 223 366 05 Fax: +357 223 366 07
2/ 12 Medlemsstat
2/ 12 Member State Applicant
Zlicin Business Centre Na Radosti 413 CZ- 155 21 Prague 5 Tjekkiet Tel: +420 (2) 333 440 25 Fax: +420 (2) 333 440 22
Zlicin Business Centre Na Radosti 413 CZ-155 21 Prague 5 Czech Republic Tel: +420 (2) 333 440 25 Fax: +420 (2) 333 440 22
Intervet Danmark AS PO Box 66 Literbuen 9 DK- 2740 Skovlunde Danmark Tel: +45 (44) 546 900 Fax: +45 (44) 531 955
Intervet Danmark AS PO Box 66 Literbuen 9 DK-2740 Skovlunde Denmark Tel: +45 (44) 546 900 Fax: +45 (44) 531 955
Intervet Baltic States Vasario 16- osios 9- 6A LT- Kauna 3000 Litauen Tel: +370 373 216 60 Fax: +370 372 012 93
Intervet Baltic States Vasario 16-osios 9-6A LT-Kauna 3000 Lithuania Tel: +370 373 216 60 Fax: +370 372 012 93
Rue Olivier de Serres Angers Technopole BP 17144 FR- 49071 Beaucouzé Cedex Frankrig Tel: +33 (2) 412 283 83 Fax: +33 (2) 412 283 00
Rue Olivier de Serres Angers Technopole BP 17144 FR-49071 Beaucouzé Cedex France Tel: +33 (2) 412 283 83 Fax: +33 (2) 412 283 00
3/ 12 Medlemsstat
3/ 12
Ansøger eller indehaver af markedsføringstilladelse
Member State Applicant
Intervet Deutschland GmbH Feldstrasse 1a DE- 85716 Unterschleissheim Tyskland Tel: +49 (89) 310 062 59 Fax: +49 (89) 310 03 27
Intervet Deutschland GmbH Feldstrasse 1a DE-85716 Unterschleissheim Germany Tel: +49 (89) 310 062 59 Fax: +49 (89) 310 03 27
3, Paparigopoulou Street GR- 152 32 Halandri Athens Grækenland Tel: +30 (210) 689 0411 Fax: +30 (210) 683 2523
3, Paparigopoulou Street GR-152 32 Halandri Athens Greece Tel: +30 (210) 689 0411 Fax: +30 (210) 683 2523
7. e. 13 Ungarn Tel: +36 (1) 456 3090 Fax: +36 (1) 456 3099
7. e.13 Hungary Tel: +36 (1) 456 3090 Fax: +36 (1) 456 3099
Magna Drive Magna Business Park Citywest Road IR- Dublin 24 Irland Tel: +353 (1) 463 7330 Fax: +353 (1) 451 1906
Magna Drive Magna Business Park Citywest Road IR-Dublin 24 Ireland Tel: +353 (1) 463 7330 Fax: +353 (1) 451 1906
4/ 12 Medlemsstat
4/ 12
Tobagi 7 IT- 20068 Peschiera Borromeo – Milano Italien Tel: +39 (02) 516 861 Fax: +39 (02) 516 866 87
Tobagi 7 IT-20068 Peschiera Borromeo – Milano Italy Tel: +39 (02) 516 861 Fax: +39 (02) 516 866 87
5/ 12 Medlemsstat
5/ 12
Wim de Korverstraat 35 NL- 5831 AN Boxmeer Nederlandene Tel: + 31 485 587 652 Fax: + 31 485 587 653
Wim de Korverstraat 35 NL-5831 AN Boxmeer The Netherlands Tel: + 31 485 587 652 Fax: + 31 485 587 653
Wybrzeze Gdynskie 6c PL- 01- 531 Warszawa Polen Tel: +48 (22) 620 1147 Fax: +48 (22) 620 2935
Wybrzeze Gdynskie 6c PL-01-531 Warszawa Poland Tel: +48 (22) 620 1147 Fax: +48 (22) 620 2935
Estrada Nacional 249, Km 14, 2 PT- 2725- 397 Mem Martins Codes Portugal Tel: +351 (21) 922 83 00 Fax: +351 (21) 920 22 31
Estrada Nacional 249, Km 14,2 PT-2725-397 Mem Martins Codes Portugal Tel: +351 (21) 922 83 00 Fax: +351 (21) 920 22 31
Palarikova 16 SK- 040 01 Kosice Slovakiet Tel: +421 (55) 676 9405 Fax: +421 (55) 676 9873
Palarikova 16 SK-040 01 Kosice Slovak Republic Tel: +421 (55) 676 9405 Fax: +421 (55) 676 9873
6/ 12 Medlemsstat
6/ 12
Intervet International Podruznica Krizna 10 SI- 1000 Ljubljana Slovenien Tel: +386 (15) 417 567 Fax: +386 (15) 233 567
Intervet International Podruznica Krizna 10 SI-1000 Ljubljana Slovenija Tel: +386 (15) 417 567 Fax: +386 (15) 233 567
Poligono Industrial “ El Montalva ” Apartado 3006 ES- 37080 Salamanca Spanien Tel: +34 (923) 190 345 Fax: +34 (923) 190 347
Poligono Industrial “ El Montalva” Apartado 3006 ES-37080 Salamanca Spain Tel: +34 (923) 190 345 Fax: +34 (923) 190 347
Walton Manor Walton Milton Keynes Buckinghamshire MK7 7AJ Det Forenede Kongerige Tel: +44 (1908) 665 050 Fax: +44 (1908) 664 778
Walton Manor Walton Milton Keynes Buckinghamshire MK7 7AJ UK Tel: +44 (1908) 665 050 Fax: +44 (1908) 664 778
Som ovennævnte Som ovennævnte
As above As above As above As above
Som ovennævnte
ANNEX II
7/ 12 BILAG II
7/ 12
8/ 12 FAGLIGE KONKLUSIONER
8/ 12 SCIENTIFIC CONCLUSIONS
Bovilis BVD blev første gang godkendt i Tyskland den 6. maj 1998 (som Bovilis BVD- MD).
Bovilis BVD was first authorised in Germany on 6 May 1998 (as Bovilis BVD-MD).
3, i direktiv 2001/ 82/ EF som en selvstændig ansøgning.
The application was made in accordance with Article 12.3 of Directive 2001/ 82/ EC as a stand alone application.
Proceduren blev indledt den 13. marts 2006.
The procedure started on 13 March 2006.
1, i direktiv 2001/ 82/ EF, med senere ændringer.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures, CMD(v), for a 60 day procedure in accordance with Article 33(1) of Directive 2001/ 82/ EC, as amended.
CMD( v) havde på dag 60 af proceduren ikke kunnet nå til enighed vedrørende de af Danmark fastholdte betænkeligheder.
The CMD(v) could not reach an agreement by day 60 of this procedure, as to where Denmark maintained their concerns.
Tyskland underrettede følgelig den 31. oktober 2006 EMEA om, at CMD( v) ikke var nået til enighed om Bovilis BVD.
Consequently Germany notified the EMEA, on 31 October 2006, that the CMD(v) failed to reach an agreement regarding Bovilis BVD.
4, i Rådets direktiv 2001/ 82/ EF, med senere ændringer.
Pursuant to Article 33(4) of Council Directive 2001/ 82/ EC, as amended, the matter has been referred to CVMP.
Denmark finder, at det påtænkte testprogram til påvisning af fravær af fremmede agenser er utilstrækkeligt til at sikre, at Bovilis BVD ikke vil gribe ind i landets nationale program til udryddelse af visse sygdomme hos dyr, og at benefit/ risk forholdet for Bovilis BVD derfor er negativt, således at godkendelse af produktet vil udgøre en potentiel alvorlig risiko for dyrs sundhed.
Denmark considers that the proposed testing regime to demonstrate freedom from extraneous agents is insufficient to ensure that Bovilis BVD would not interfere with their national eradication campaigns for certain animal diseases and that therefore the benefit: risk assessment for Bovilis BVD is negative and authorisation of the product would represent a potential serious risk to animal health.
4, i direktiv 2001/ 82/ EF, med senere ændringer.
During its meeting of November 2006, the CVMP started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended for Bovilis BVD.
Indehaveren af markedsføringstilladelsen skulle forelægge alle oplysninger, der begrunder, at risk- benefit forholdet for den behandlede dyreart er positivt.
The Marketing Authorisation Holder should provide all supporting data to justify a positive benefit-risk ratio for the treated animal.
Skønt en accidentel serokonvertering over de opførte fremmede agenser ville få skadelige konsekvenser for dyresundhedsstatus i en stat, hvor de fire anførte sygdomme ikke forekommer, anses risk- benefit forholdet fortsat for at være positivt på grund af den lave risiko for kontaminering af produktet.
Although the consequences of an accidental seroconversion against the listed extraneous agents would damage the animal health status of a country free from the four specified diseases, the benefit: risk evaluation remains positive due to the low risk of contamination of the product.
Det er værd at bemærke, at den første EU- markedsføringstilladelse for Bovilis BVD blev udstedt i 1998, og at vaccinen aktuelt er godkendt i 14 EU- medlemsstater.
It is worthy of note that the first EU marketing authorisation for Bovilis BVD was granted in 1998, and the vaccine is currently authorised in 14 EU Member States.
Der foreligger ingen
Considering all the measures taken, it is very unlikely that any contamination of Bovilis BVD could
9/ 12 videnskabelige beviser for, i hvilket omfang supplerende testning vil minimere risikoen for eventuel serokonvertering fremkaldt af vaccinen.
9/ 12 firstly occur, and secondly that such contamination would eventually lead to seroconversion, even in a small number of vaccinated animals.
GMP) konkluderer CVMP, at ansøgeren har truffet tilstrækkelige foranstaltninger til at garantere kvaliteten og sikkerheden af Bovilis BVD.
Based on the current requirements and the relevant safeguards (e. g., GMP) the CVMP concludes that the Applicant has taken adequate measures to guarantee the quality and safety of Bovilis BVD.
Mund - og klovsygevirus er praktisk talt eksotisk i Vesteuropa, og skønt blå tunge for nylig har ændret status, er denne sygdom ikke almindeligt forekommende eller endemisk i størstedelen af EU, således risikoen i praksis skulle være mindre for disse to agenser.
Foot and Mouth virus is virtually exotic to Western Europe and Bluetongue, although of a recent change in status, is not ubiquitous or endemic in the majority of the EU, so for these 2 agents the practical risks should be lower.
Generelt kan fravær af fremmede agenser i vacciner sikres ved følgende foranstaltninger:
In general, the absence of extraneous agents in vaccines can be ensured by:
Overholdelse af GMP i produktionssystemet 2.
GMP compliance of the production system 2.
Testning af råmaterialerne for fremmede agenser 3.
Extraneous agents testing of raw materials 3.
Om nødvendigt, testning af batcher af det færdige præparat for fremmede agenser.
Extraneous agents testing of batches of finished product, if required.
Bovilis BVD- vaccine produceres og testes i overensstemmelse med de pågældende krav i direktiv 2001/ 82/ EF, de pågældende EU- retningslinjer og de pågældende monografier i Ph. Eur.
The production and testing of Bovilis BVD vaccine are in accordance with the relevant requirements of Directive 2001/ 82/ EC, the relevant EU guidelines and the relevant monographs of the Ph. Eur.
Som konklusion er det CVMP' s opfattelse, at:
In conclusion, CVMP is of the opinion that:
• produktionen af Bovilis BVD- vaccine er i overensstemmelse med GMP- krav
• the production of Bovilis BVD vaccine is in compliance with GMP requirements
CVMP har konstateret uoverensstemmelser (hvad angår testning for fremmede agenser) i Ph. Eur' s. monografier for inaktiverede bovine vacciner og har skriftligt anmodet EDQM om at tage dette punkt op.
CVMP have noted the inconsistencies (with regard to extraneous agents testing) in the Ph. Eur. monographs for inactivated bovine vaccines and have written to the EDQM and asked them to address this.
CVMP konkluderede, at benefit/ risk forholdet for Bovilis BVD er gunstigt.
The CVMP has concluded that the risk/ benefit for Bovilis BVD is favourable.
10/ 12 BILAG III
10/ 12 ANNEX III
PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT
11/ 12 De gældende tekster til produktresumé, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen.
11/ 12 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
London, juni 2008 EMEA/ 532090/ 2007 – Rev. 1
London, June 2008 EMEA/ 532090/ 2007– Rev.1
4 VEDRØRENDE BOVILIS BVD/ BOVILIS BVD- MD
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR BOVILIS BVD/ BOVILIS BVD-MD
Bovilis BVD/ Bovilis BVD- MD er en inaktiveret virus- vaccine, som indeholder inaktiveret antigen af cytopatisk BVD- virusstamme C- 86.
Bovilis BVD/ Bovilis BVD-MD is an inactivated virus vaccine containing the inactivated antigen of cytopathic BVD virus strain C-86.
Produktet er indiceret til aktiv immunisering af køer og kvier fra ottemåneders- alderen til beskyttelse af fosteret mod transplacental infektion med BVDV.
The product is indicated for the active immunisation of cows and heifers from eight months of age onwards to protect the foetus against transplacental infection with BVDV.
Bovilis BVD blev første gang godkendt i Tyskland som Bovilis BVD- MD.
Bovilis BVD was first authorised in Germany as Bovilis BVD-MD.