البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
babesia canis, inactivated, babesia rossi, inactivated
Intervet International BV
QI07AO
vaccine against babesiosis in dogs
Dogs
Immunologicals for canidae
For active immunisation of dogs of six months of age or older against Babesia canis to reduce the severity of clinical signs associated with acute babesiosis (B. canis) and anaemia as measured by packed cell volume.Onset of immunity: Three weeks after the basic vaccination course.Duration of immunity: Six months after the last (re-)vaccination.
Revision: 4
Withdrawn
2004-09-02
Medicinal product no longer authorised B. PACKAGE LEAFLET 14 Medicinal product no longer authorised PACKAGE LEAFLET 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Piro lyophilisate and solvent for suspension for injections for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Per 1 ml dose of the reconstituted product: 606 (301-911) total antigenic mass units of soluble parasite antigen (SPA) from _Babesia canis_ and _Babesia rossi _ cultures Adjuvant: 250 (225-275) μg saponin (from the solvent) 4. INDICATION(S) For active immunisation of dogs of 6 months of age or older against _Babesia canis_ to reduce the severity of clinical signs associated with acute Babesiosis ( _B. canis_ ) and anaemia as measured by Packed Cell Volume (PCV). Onset of immunity: Three weeks after the basic vaccination course. Duration of immunity: 6 months after the last (re-)vaccination . 5. CONTRAINDICATIONS Do not use in pregnant or lactating bitches. 6. ADVERSE REACTIONS Commonly reported post-vaccination reactions are a diffuse swelling and/or hardened nodule, accompanied by pain, at the site of vaccination. In general this disappears within 4 days. In rare cases, the reactions after the second dose of vaccine may remain for 14 days. In addition, systemic signs, such as lethargy and a reduction in appetite may also commonly occur, sometimes accompanied by pyrexia and a stiff gait. These reactions should disappear within 2-3 days. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Dogs 15 Medicinal product no longer authorised 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 1 ml reconstituted vaccine, via subcutaneous injection. _ _ _Vaccination scheme: _ Basic vaccination course: First injec اقرأ الوثيقة كاملة
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Piro lyophilisate and solvent for suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per 1 ml dose: Active substance: 606 (301-911) total antigenic mass units of soluble parasite antigen (SPA) from _Babesia canis_ and _Babesia rossi _ cultures Adjuvant (in the solvent) 250 (225-275) μg saponin For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of dogs of 6 months of age or older against _Babesia canis_ to reduce the severity of clinical signs associated with acute Babesiosis ( _B. canis_ ) and anaemia as measured by Packed Cell Volume (PCV). Onset of immunity : Three weeks after the basic vaccination course. Duration of immunity : 6 months after the last (re-)vaccination. 4.3 CONTRA-INDICATIONS See section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Only healthy dogs should be vaccinated. In particular, chronic asymptomatic carriers should be identified and treated before vaccination, with substances that do not compromise immunological responsiveness. It is recommended that vaccinations are given at least one month before the tick season. As active babesia infection might interfere with the development of protective immunity, it is recommended to reduce exposure to ticks during the period of vaccination. 2 Medicinal product no longer authorised Currently there is only evidence of the efficacy of the vaccine against challenge with _B. canis_ . There is a possibility that vaccinated dogs facing a challenge with other babesia's may develop disease and require treatment. Vaccination with Nobivac Piro does not prevent infection. As a consequence a milder form of disease caused by _B. canis_ can occur. If mild babes اقرأ الوثيقة كاملة