ChiroRab

ChiroRab Mechanism of Action

rabies vaccine

Manufacturer:

Chiron Behring Vaccines

Distributor:

Glovax Lifescience

Marketer:

Glovax Lifescience
Full Prescribing Info
Action
Pre-clinical Studies: See Figure 1.

Click on icon to see table/diagram/image

Clinical Trials - India: See Table 1.

Click on icon to see table/diagram/image

Clinical Trials - Global: See Table 2.

Click on icon to see table/diagram/image

Intramuscular Route of Administration: Pre-exposure Prophylaxis (M49P2): See Figure 2 and Table 3.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Post-exposure Prophylaxis (V49_25): See Figure 3 and Table 4.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Post-exposure Prophylaxis (V49_24): See Figure 4 and Table 5.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Post-exposure Prophylaxis (M49P1): See Figure 5 and Table 6.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Intradermal Route of Administration: Pre-exposure Prophylaxis (M49P2): See Figure 6 and Table 7.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Post-exposure Prophylaxis (M49P3): See Figure 7 and Table 8.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Special Populations: Post-exposure Prophylaxis in Pregnant Women: Essen regimen (1-1-1-1-1) was used for the subjects involved, one dose was administered at Days 0, 3, 7, 14, and 28.
ChiroRab is safe for pregnant women and did not interfere with the development of the fetuses or infants.
All of the infants exhibited normal development.
No miscarriages, stillbirths, or fetal malformations were reported.
No rabies cases were reported for any of the subjects or babies.
Immunogenicity of ChiroRab in Immunocompromised Individuals: See Figure 8 and Table 9.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Post-exposure Prophylaxis in Malnourished Children: See Figure 9 and Table 10.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Efficacy of ChiroRab: Phase IV study to evaluate the efficacy in terms of 1 year survival with ChiroRab administered intradermally in subjects exposed to laboratory confirmed rabid animals has shown that 12 months after exposure, all 113 patients were alive and no patient had succumbed to rabies or died of other causes.
Safety of ChiroRab: ChiroRab has an excellent safety and tolerability profile. Safety of ChiroRab has been established in more than 20 clinical trials worldwide in both children, adults and post-marketing reports.
In clinical trials, ChiroRab has been associated with local reactions, such as injection site pain (30-85%) and induration (15-35%).
Most of the side-effects in clinical studies were minor, self-limiting and required no treatment.
ChiroRab is safe to administer in pregnant and immunocompromised individuals.
Adverse reactions observed in clincal trials and during the post-marketing period: Very common (>1/10): Injection site reaction, Injection site swelling.
Common (>1/100, <1/10): Injection site erythema, Fatigue, Pyrexia, Headache, Myalgia, Gastrointestinal disorders.