País: Reino Unido
Idioma: inglés
Fuente: VMD (Veterinary Medicines Directorate)
Clostridioides difficile, Clostridium perfringens
Laboratorios Hipra SA
QI09AB12
Clostridioides difficile, Clostridium perfringens
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Inactivated Bacterial Vaccine
Authorized
2021-11-24
Revised: August 2022 AN: 00754/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Suiseng Diff/A suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains: ACTIVE SUBSTANCES: _Clostridioides difficile_, toxoid A (TcdA) ≥ 1.60 RP* _Clostridioides difficile_, toxoid B (TcdB) ≥ 1. 65 RP* _Clostridium perfringens_ type A, α-toxoid ≥ 1.34 RP* * RP: Relative Potency determined by ELISA ADJUVANTS: Aluminium hydroxide gel 0.6 g Ginseng extract (equivalent to ginsenosides) DEAE-dextran For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Yellowish-white suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (pregnant sows and gilts). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the passive immunisation of neonatal piglets by means of the active immunisation of breeding sows and gilts: - to prevent mortality and reduce clinical signs and macroscopic lesions caused by _C. difficile, _toxins A and B_._ - to reduce clinical signs and macroscopic lesions caused by _C. perfringens_ type A, α-toxin. The reduction of the occurrence of neonatal diarrhoea has been demonstrated under field conditions. Onset of immunity: Protection was demonstrated in suckling piglets on the first day of life in challenge studies. Revised: August 2022 AN: 00754/2022 Page 2 of 5 Duration of immunity: Neutralising protective antibodies transferred via colostrum to the piglets were present up to 28 days after birth in the majority of the piglets. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance, to the adjuvant or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Protection of piglets is achieved by colostrum intake. Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum within the first hours of life. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for Leer el documento completo