Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus
Intervet International B.V.
QI01AD03
avian infectious laryngotracheitis and Marek’s disease vaccine (live)
Chicken
Immunologicals for aves, Live viral vaccines
For active immunisation of one-day-old chicks to reduce mortality, clinical signs and lesions due to infection with avian infectious laryngotracheitis (ILT) virus and Marek’s disease (MD) virus.
Revision: 5
Authorised
2015-07-03
13 B. PACKAGE LEAFLET 14 PACKAGE LEAFLET: INNOVAX-ILT CONCENTRATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CHICKENS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer THE NETHERLANDS 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Innovax-ILT concentrate and solvent for suspension for injection for chickens 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose (0.2 ml) of reconstituted vaccine contains: Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus: 10 3.1 – 10 4.1 PFU 1 . 1 PFU: plaque forming units. Concentrate and solvent for suspension for injection. Cell concentrate: off-red to red cell concentrate. Solvent: clear, red solution. 4. INDICATION(S) For active immunization of one-day-old chicks to reduce mortality, clinical signs and lesions due to infection with avian infectious laryngotracheitis (ILT) virus and Marek’s disease (MD) virus. Onset of immunity: ILT: 4 weeks, MD: 9 days. Duration of immunity: ILT: 60 weeks, MD: entire risk period. 5. CONTRAINDICATIONS None. 6. ADVERSE REACTIONS None known. If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 15 7. TARGET SPECIES Chickens. 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION After dilution, administer 1 dose of 0.2 ml of vaccine per chicken by subcutaneous injection in the neck. 9. ADVICE ON CORRECT ADMINISTRATION The bag of vaccine should be gently swirled frequently during vaccination to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titre is administered (e.g. during long vaccination sessions). Preparation Lesen Sie das vollständige Dokument
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Innovax-ILT concentrate and solvent for suspension for injection for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) of reconstituted vaccine contains: ACTIVE SUBSTANCE: Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus: 10 3.1 – 10 4.1 PFU 1 . 1 PFU: plaque forming units. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for suspension for injection. Cell concentrate: off-red to red cell concentrate. Solvent: clear, red solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of one-day-old chicks to reduce mortality, clinical signs and lesions due to infection with avian infectious laryngotracheitis (ILT) virus and Marek’s disease (MD) virus. Onset of immunity: ILT: 4 weeks, MD: 9 days. Duration of immunity: ILT: 60 weeks, MD: entire risk period. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals As this is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys. Safety trials have shown that the strain is safe for turkeys. However, precautionary measures 3 have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys. During subcutaneous vaccination, care should be taken to prevent damage of the blood vessels in the neck of the chickens. Special precautions to be taken by the person administering the veterinary medicinal product to animals The handling of liquid nitrogen should take place in a well-ventilated area. Innovax-ILT is a virus suspension packed in glass ampoules and stored in liquid nitrogen. Before withdrawing ampoules from the liquid nitrogen ca Lesen Sie das vollständige Dokument