Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Chlamydophila abortus live attenuated strain ts 1b
Intervet Ireland Limited
QI04AE01
Chlamydophila abortus live attenuated strain ts 1b
10^5 - 10^6.9 inclusion-body forming units
Lyophilisate and solvent for suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Sheep
chlamydia
Immunological - Live Vaccine
Authorised
2002-11-15
Health Products Regulatory Authority 15 January 2022 CRN00CRJG Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enzovax 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active substance Per dose_ Live, attenuated strain ts1B_ Chlamydophila abortus _10 5.0 -10 6.9 IFU* (* Inclusion-body forming units) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: off-white to cream-coloured pellet. Solvent: colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Susceptible female breeding sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of susceptible female breeding sheep to reduce abortion caused by _Chlamydophila abortus _ infection. Challenge studies have demonstrated that protection against Enzootic abortion and excretion of _Chlamydophila abortus _ post-challenge is undiminished for at least three years post vaccination with Enzovax. Field studies in endemically infected flocks maintaining a policy of vaccinating incoming ewes with Enzovax indicate that enzootic abortion levels remain very low in ewes vaccinated 4 years previously. 4.3 CONTRAINDICATIONS Do not vaccinate pregnant animals Do not vaccinate animals less than 4 weeks before mating. Do not vaccinate animals which are being treated with antibiotics, particularly tetracyclines. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES _Chlamydophila abortus _is only one of the causes of abortion in sheep. If the abortion rate remains unchanged in flocks which have been vaccinated with Enzovax it is recommended that veterinary advice is sought. The epidemiology of abortion due to _Chlamydophila abortus _in ewes involves a long incubation period. Ewes that abort in any lambing season have usually been infected at the previous lambing. Field trial data indicate that vaccinating incubating ewes will reduce the incidence of abortion, but a proportion can still go on to abort. Care should be taken in handling Prečítajte si celý dokument