Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
inactivated Bordetella bronchiseptica, strain 833CER / recombinant type-D Pasteurella-multocida toxin (PMTr)
Laboratorios Hipra S.A.
QI09AB04
inactivated Bordetella bronchiseptica, strain 833CER / recombinant type-D Pasteurella-multocida toxin (PMTr)
Pigs (gilts and sows)
Immunologicals
For the passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella-bronchiseptica and Pasteurella-multocida infections during the fattening period. Challenge studies have demonstrated that passive immunity lasts until piglets are six weeks of age while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and weight loss) are observed until slaughter.
Authorised
2010-09-16
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: RHINISENG suspension for injection for pigs 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: LABORATORIOS HIPRA, S.A. Avda la Selva, 135 17170 Amer (Girona) SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT RHINISENG suspension for injection for pigs. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each dose of 2 ml contains: ACTIVE SUBSTANCES: Inactivated _Bordetella bronchiseptica, _ strain 833CER: ........................................9.8 BbCC(*) Recombinant Type D _ Pasteurella multocida_ toxin (PMTr): ............................ ≥ _ _ 1 MED 63 (**) (*) _Bordetella bronchiseptica _ Cell Count in log 10 . (**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by subcutaneous route induces seroconversion in at least 63 % of the animals. ADJUVANTS: Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium) DEAE-Dextran Ginseng EXCIPIENT: Formaldehyde .................................................................................................................. 0.8 mg White homogeneous suspension. 4. INDICATION(S) For passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with _Bordetella bronchiseptica_ and _Pasteurella multocida_ infections during the fattening period. Challenge studies have demonstrated that passive immunity lasts until piglets are 6 weeks of age while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and weight loss) are observed until slaughter. 5. CONTRAINDICATIONS 19 Do not use in case of hypersensitivity to the active substances, to the adju Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RHINISENG suspension for injection for pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains: ACTIVE SUBSTANCES: Inactivated _Bordetella bronchiseptica, _ strain 833CER: ........................................9.8 BbCC(*) Recombinant Type D _ Pasteurella multocida_ toxin (PMTr): ............................ ≥ _ _ 1 MED 63 (**) (*) _Bordetella bronchiseptica _ Cell Count in log 10 . (**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by subcutaneous route induces seroconversion in at least 63% of the animals. ADJUVANTS: Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium) DEAE-Dextran Ginseng EXCIPIENT: Formaldehyde .................................................................................................................. 0.8 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White homogeneous suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (sows and gilts). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with _Bordetella bronchiseptica_ and _Pasteurella multocida_ infections during the fattening period. Challenge studies have demonstrated that passive immunity lasts until piglets are 6 weeks of age while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and weight loss) are observed until slaughter. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances, to the adjuvants or to any of the excipients. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in a Preberite celoten dokument