Krajina: Taliansko
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
Intervet UK Limited
Suspension for injection
2010-08-09
Revised: October 2010 AN: 01657/2009 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Salenvac 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per ml: ACTIVE SUBSTANCE: Formalin killed cells of _Salmonella _Enteritidis phage type 4 2 x 10 9 ADJUVANT: Alhydrogel, (containing 3% aluminium hydroxide) 250 mg EXCIPIENT: Thiomersal (preservative) 0.13 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens: - layers and breeders 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of poultry against _Salmonella _Enteritidis_, _to reduce shedding of _S. _Enteritidis into the environment. _ _ Antibodies against _S. _Enteritidis develop within a few weeks of the second vaccination. A second peak is achieved shortly after a third vaccination. These antibodies have been shown to persist for at least 60 weeks. Passive immunity will be transferred via the egg to the progeny for at least 57 weeks. 4.3 CONTRAINDICATIONS Do not use in laying birds. 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Cross reactions in tests for _S. _Pullorum_ _are possible but at a low level and may be distinguished from true infection when dilutions of sera are tested, or following heat inactivation. Where serology is positive for _S. _Pullorum, the diagnosis should be confirmed by bacteriology. Hygienic measures and monitoring should not be neglected. Revised: October 2010 AN: 01657/2009 Page 2 Prečítajte si celý dokument