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Prevodi: en > sl
101–103/103
approved vaccine
101 Prevajalska redakcija
izobraževanje
CELEX: 32001D0660
Following written information from the contractor about the supply and distribution to the approved premises of the antigen purchased in accordance with Decision 2000/569/EC, it appears appropriate to update the Annex to Decision 2000/112/EC detailing the distribution between antigen banks of antigen reserves established within the framework of the Community action concerning reserves of foot-and-mouth disease vaccines and amending Commission Decisions 93/590/EC and 97/348/EC.
Po pisnih informacijah pogodbenika o dobavi in razdelitvi antigena, kupljenega v skladu z Odločbo 2000/569/ES, odobrenim mestom, se zdi ustrezno, da se dopolni Priloga k Odločbi 2000/112/ES o podrobni razdelitvi zalog antigenov, uvedenih v okviru ukrepa Skupnosti v zvezi z zalogami cepiv proti slinavki in parkljevki, med banke antigenov, in o spremembi odločb 93/590/ES in 97/348/ES.
102 Prevajalska redakcija
RS
EMEA
• 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.
103 Prevod
gospodarstvo
CELEX: 32004D0117
the animal was vaccinated on............................ ( 5 ) against equine viral arteritis under official veterinary supervision with a vaccine approved by the competent authority, according to the following programmes for initial vaccination and has been re-vaccinated at regular intervals ( 3 ) ( 4 );
se je žival pod uradnim veterinarskim nadzorom cepila dne ………………………………..( 5 ) proti kužnemu arteritisu kopitarjev s cepivom, ki ga je odobril pristojni organ, v skladu z naslednjimi programi prvega cepljenja ter se je v rednih presledkih ponovno cepila( 3 ) ( 4 ).
Prevodi: en > sl
101–103/103
approved vaccine