البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: HMA (Heads of Medicines Agencies)
reovirus 1250 ELISA
Intervet Intenational BV
QI01AA04
Emulsion for injection
Avian reovirus vaccine
Chicken Young
2012-02-28
Dokument1 PARTICULARS TO APPEAR ON THE OUTER PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Reo ERS inac 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 0.5 ml: Inactivated Reovirus strain ERS inducing 6.7 log 2 and ≤ 10.0 log 2 antibody ELISA units Light liquid paraffin (215 mg) 3. PHARMACEUTICAL FORM Emulsion for injection 4. PACKAGE SIZE 1000 doses (500 ml) 12 x 1000 doses (500 ml) 5. TARGET SPECIES Chicken 6. INDICATION Vaccination against enteric Reovirus infections 7. METHOD AND ROUTE(S) OF ADMINISTRATION i.m. injection of 0.5 ml Read the package leaflet before use. 8. WITHDRAWAL PERIOD Zero days 9. SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous – see package leaflet before use. 10. EXPIRY DATE EXP {month/year} Once broached use within 3 hours Dokument1 11. SPECIAL STORAGE CONDITIONS Store between 2°C and 8°C. Do not freeze. Protect from light. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Dispose of waste material in accordance with local requirements. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only 14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands As represented by the national company 16. MARKETING AUTHORISATION NUMBER(S) 17. MANUFACTURER’S BATCH NUMBER Lot {number} Dokument اقرأ الوثيقة كاملة
NOBILIS® REO E I. SUMMARY OF PRODUCT CHARACTERISTICS Dokument1 NOBILIS® REO ERS INAC FEHLER! VERWEISQUELLE KONNTE NICHT GEFUNDEN WERDEN. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Reo ERS inac 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.5 ml: ACTIVE SUBSTANCE: Inactivated Reovirus strain ERS inducing 6.7 log 2 and ≤10.0 log 2 antibody ELISA units ADJUVANT: Light liquid paraffin, 215 mg For a list of excipients see section 6.1 3. PHARMACEUTICAL FORM Emulsion for injection, white to nearly white (after shaking) 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chicken 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of chickens as an aid in the protection of their progeny against weight gain losses due to enteric reovirus (ERS) infection, and reduction of virus replication in target organs. Onset of immunity: 4 weeks after two vaccinations Duration of immunity: 47 weeks after two vaccinations 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinate healthy birds only. For birds in lay please see section 4.7. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS To the user: This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this product, seek prompt medical advic اقرأ الوثيقة كاملة