[Thermostability of rabies vaccine, type Fuenzalida & Palacios, for human use].
Ten lots of Fuenzalida & Palacios type antirabies vaccine for human use, produced at the Instituto Butantan (São Paulo, Brazil) were stored at temperatures of 45, 37, 28 and 2-8 degrees C. The potency of each lot was determined in samples taken at varied time intervals using the NIH method and lots presenting antigenic values > or = 0,3 were considered satisfactory for use. After 2 hours at 45 degrees C the antigenic value of one out of 10 lots tested was found to be less than the minimum required value. At 37 degrees C all lots maintained satisfactory antigenic values until the third day of storage, whilst at 28 and 2-8 degrees C the potency was fully maintained, respectively for 10 and 360 days. At the ideal temperature of 2-8 degrees C, 100% of the tested vaccines maintained the minimum required antigenicity for a longer period (16 months) than the expiration time of 6-12 months usually recommended for this type of biological produced in Latin American and Caribbean countries. Thus, the obtained data suggested that in countries still producing Fuenzalida & Palacios type vaccine, the expiration tim could be extended to 16 months, what could prevent the unnecessary discarding of products still in useful condition.
Albas
A
A
Seção de Vírus Neurotrópicos, Instituto Butantan, São Paulo, Brasil.
Fuches
R M
RM
Gallina
N M
NM
Mendonça
R M
RM
Fang
F L
FL
Valentini
E J
EJ
D004355:Drug Stability; D004356:Drug Storage; D000939:Epitopes / Q000276:immunology; D006801:Humans; D011819:Rabies Vaccines / Q000276:immunology / Q000592:standards*; D013696:Temperature
D000939:Epitopes; D011819:Rabies Vaccines
Termoestabilidade da vacina contra a raiva, tipo Fuenzalida & Palacios, uso humano.