• The batches passed the Ph. Eur. potency test in pigs at 1/ 3 dose, which provides evidence of target animal efficacy. • The batches are formulated with a fixed quantity of bacteria, quantified using an approved and validated method. • The batches passed the test for target animal safety according to Ph. Eur monograph 0064. • The batches were commercial batches manufactured to the production methods and specification described in the MA. • The potencies of the two reference batches (9097 and 9861) are higher than the PEI reference serum and the reference vaccine batch 8500. • The MAH followed the correct SOP for replacement at the time the replacements were made.
• So serije v skladu z Evropsko farmakopejo prestale test učinkovitosti pri prašičih in z 1/ 3 odmerka, kar dokazuje učinkovitost pri ciljnih živalih. • Se serije oblikujejo z ustaljeno količino bakterij, ki jo odmerijo z odobreno in potrjeno metodo. • So serije prestale test varnosti pri ciljnih živalih v skladu z monografijo Evropske farmakopeje 0064. • So bile te serije za komercialne namene in izdelane s postopki izdelave in specifikacijami, ki so opisane v dovoljenju za promet z zdravilom. • Učinkovitosti obeh referenčnih serij (9097 in 9861) sta večji od referenčnega seruma PEI in serije referenčnega cepiva 8500. • Imetnik dovoljenja za promet z zdravilom je pri zamenjavah upošteval ustrezne standardne delovne postopke za zamenjavo.