ChiroRab

One vial of powder and solvent for solution for injection for one immunisation dose (1 ml) contains inactivated rabies virus (strain Flury LEP), potency ≥2.5 IU; Host system-primary chicken fibroblast cell cultures.
ChiroRab is a highly purified, highly immunogenic modern cell-culture PCECV with a high potency level per dose.

Pre-clinical Studies: See Figure 1.

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Clinical Trials - India: See Table 1.

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Clinical Trials - Global: See Table 2.

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

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

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

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

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

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

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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.

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

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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.

Active immunisation against rabies.
Pre-exposure immunisation (preventative, prior to exposure): Immunisation prior to possible infection with rabies, particularly for vets, veterinary medicine students, animal keepers, hunters, forestry workers, animal handlers, butchers, personnel in rabies research laboratories etc., or prior to visits to areas in which rabies is endemic (rabies infected areas).
Post-exposure treatment (after exposure): Treatment after contact with animals which are rabid or suspected to be rabid, or after contact with an inoculated rabies carcass.

Posology & Administration of Rabies Vaccine: See Tables 11 and 12.

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ChiroRab can be given either as IM or ID using various schedules for PrEP and PEP and as booster vaccinations in all age groups.
Prior to exposure immunisation: One vaccination on days 0, 7 and 21 or 28.
After exposure: Begin with the course of immunisation immediately with one single dose of vaccine on days 0, 3, 7, 14, 28 (5-dose schedule for IM) + 1 x 20 IU/kg bodyweight human rabies immunoglobulin or 40 IU/kg bodyweight equine rabies immunoglobulin simultaneously with the first dose of ChiroRab.

Immunisation prior to exposure: It is advisable to avoid pre-exposure (prophylactic) immunisation in individuals with acute disorders requiring treatment. If complications arise after vaccination, this should be considered a contraindication for further administration of the same vaccine, until the causes of the complications have been clarified.
In individuals with known allergy to one of the constituents of ChiroRab, use of this vaccine is contraindicated.
Treatment after exposure: In view of the fact that rabies is a fatal disease, there are no contraindications to immunisation after suspected exposure.

In extreme rare cases in which subjects have reacted with clinical symptoms such as urticaria (nettle rash), lip and epiglottis oedema, laryngo- or bronchospasm, a fall in blood pressure, or shock after eating chicken protein, the immunisation should be conducted only under close clinical monitoring, and with the appropriate facilities for emergency treatment available.
ChiroRab contains polygeline and may contain residual amounts of the antibiotics amphotericin B, chlortetracycline, neomycin and this could potentially cause allergic reactions.
In patients with known hypersensitivity to constituents of the vaccine receiving post-exposure treatment, appropriate medical treatment addressing anaphylactic shock should always be on-hand during vaccination, or alternatively another equivalent modern cell culture rabies vaccine should be used.
Do not administer by intravascular injection. If the vaccine is inadvertently administered intravascularly (in a blood vessel), there is a risk of adverse reactions, with shock potentially occurring in extreme cases.
Do not mix vaccine with rabies immunoglobulin in the same syringe.

No risk to the breast-feeding infants due to ChiroRab vaccination.
Pregnancy is not a contraindication to Rabies PEP with ChiroRab.

Mild reactions at the injection site, such as pain, redness, swelling or induration are possible. More marked local reactions, fever, headache, myalgia, lymph node swelling, fatigue, arthritis, and gastrointestinal disorders may occasionally occur.
Rare are circulatory reactions, sweating, chills, paraesthesias and allergic reactions; these require treatment only in exceptional cases.
There have been isolated reports of inflammatory and demyelinating neurological disorders, such as progressive ascending paralysis or optic neuritis in individual cases.
On the basis of currently available data, the possibility cannot be completely excluded that in rare cases immunisation may induce an acute episode in patients with an autoimmune disorder (such as multiple sclerosis) or with an appropriate genetic predisposition. However, there is no evidence of an increased frequency of autoimmune disorders after immunisation.

To be stored at +2°C to +8°C during shelf life.

Vaccines, Antisera & Immunologicals

J07BG01 - rabies, inactivated, whole virus ; Belongs to the class of rabies viral vaccines.

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