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Abhayrab Purified Rabies Vero Cell Vaccine_edited.jpg

Abhayrab

Full Prescribing Information

Contents

Purified vero cell rabies vaccine.

Action

Pharmacotherapeutic group: Purified inactivated rabies vaccine prepared on Vero Cells. For the prophylactic or post exposure immunization. Prepared using L. Pasteur 2061/Vero Rabies Strain.
Pharmacology: Bioavailability and Pharmacokinetics: The vaccines used for pre-exposure and post-exposure vaccination are the same, but the immunization schedule differs. Rabies immunoglobulin is used only for post-exposure prophylaxis. Modern vaccines of cell-culture or embryonated-egg origin are safer and more effective than the older vaccines, which were produced in brain tissue. These modern rabies vaccines are now available in major urban centres of most countries of the developing world. Rabies immunoglobulin, on the other hand, is in short supply worldwide and may not be available, even in major urban centres, in many dog rabies-infected countries.

Indications/Uses

For active immunization against rabies, both for prophylaxis and post-bite therapy with all age group of humans.
For immunization against rabies after exposure (after contact with a rabid or suspected rabid animal).
For prophylactic immunization of all high-risk individuals such as veterinarians, municipal workers, medical and paramedical personnel and zoo personnel, hunters, laboratory personnel, working with suspected rabies materials and pet owners.

Dosage/Direction for Use

PRE-EXPOSURE PROPHYLAXIS (prior to exposure): Intradermal (ID) Regimen 0.1 mL at one site only (Adults: deltoid area of the arm, Children: anterolateral area of the thigh acceptable) on days 0, 7, and 21/28.
Intramuscular (IM) Regimen: 1 vial of 0.5 mL PVRV at on site only (Adults: deltoid area of the arm, Children: anterolateral area of the thigh acceptable) on days 0, 7, and 21/28.
Booster Doses: One booster dose should be given every one to three (1-3) years depending on risks of exposure.
POST-EXPOSURE TREATMENT (after exposure): Intramuscular Schedule: One dose is equivalent to 1 vial of 0.5 mL of Abhayrab.
To be given either as 5-dose IM regimen (1 dose on days 0,3,7,14 and 28) OR as 2-1-1 regimen (2 doses are given on day 0 in the deltoid or anterolateral region, right and left side. In addition, 1 dose in the deltoid or anterolateral region, right or left side).
Intradermal Schedule: One dose is equivalent to 0.1 mL of Abhayrab WHO recommended the following intradermal regimen for post-exposure immunization: Thai Red Cross (TRC) 2-2-2-0-1-1 regimen: One dose is given over each left and right deltoid on days 0,3,7. One dose at single site in deltoid on day 28/30 and day 90.
Updated TRC regimen (2-2-2-0-2): Day 90 dose has been transferred to day 28/30. One dose is given over each deltoid on days 0,3,7 and 28/30.

Special Precautions

Concurrent use of immunosuppressant agents like corticosteroids.
In case of severe bites, and site of injuries near the head, local infiltration of the wound with Antirabies immunoglobulin is recommended.
Delay in the commencement of post-bite therapy, incomplete and irregular therapy can cause failure of protection.

Adverse Reactions

Local minor events: Mild pain, Erythema, Induration, Pruritus, Rash, Oedema at the site injection.
Systemic mild events: Mild fever, Headache, Myalgia, Malaise.
Very rarely: High fever, Gastrointestinal disorders, Lymphadenopathy, Arthritis, anaphylaxis.

Abhayrab Clinical Trial Compilation

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