Pharmacotherapeutic Group: Rabies vaccines. ATC Code: J07BG01.
Pharmacology: Pharmacodynamics: Pre-exposure: The serum antibody level ≥ 0.5 IU/mL considered as protective by the WHO is achieved after injection of 3 doses at D0, D7 and D28 (or D21). This immunity should be maintained with booster doses.
Post-exposure: Post-exposure treatment was studied in adults exposed to the rabies virus. The subjects received 5 doses of the vaccine via the intramuscular route at D0, D3, D7, D14 and D28, as well as rabies immunoglobulins. In all subjects, the serum antibody level exceeded the threshold of 0.5 IU/mL, considered as protective by WHO, from the third injection at D14. For subjects already immunized, the administration of 2 doses 3 days apart (D0 and D3) post-exposure makes it possible to achieve a serum antibody level > 0.5 IU/mL, considered as protective by WHO. The administration of rabies immunoglobulins is not necessary in this case. Slightly lower mean neutralizing antibody titres may be observed when human rabies immunoglobulins (HRIG) or equine rabies immunoglobulins (ERIG) are administered at the same time as the first two doses of rabies vaccine, in accordance with the Zagreb regimen.
Pharmacokinetics: No pharmacokinetic studies were performed.
Toxicology: Preclinical safety data: Toxicity studies in animals (acute, sub-acute and chronic toxicity) do not indicate any toxic effects or target organ toxicity.