For intramuscular use only. The individual dose for adults, children, and infants is 1 mL.
In adults, administer vaccine by IM injection into the deltoid muscle. In small children and infants, administer vaccine into the anterolateral zone of the thigh. The gluteal area should be avoided for vaccine injections, since administration in this area may result in lower neutralizing antibody titers. Care should be taken to avoid injection into or near blood vessels and nerves. After aspiration, if blood or any suspicious discoloration appears in the syringe, do not inject but discard contents and repeat procedure using a new dose of vaccine at a different site.
Preexposure Dosage: Primary Immunization: In the US, ACIP recommends 3 injections of 1 mL each: 1 injection on Day 0 and 1 on Day 7, and 1 either on Day 21 or 28 (for criteria for preexposure vaccination, see Table 1).
Booster Immunization: The individual booster dose is 1 mL, given intramuscularly.
Booster immunization is given to persons who have received previous rabies immunization and remain at increased risk of rabies exposure by reasons of occupation or avocation.
Persons who work with live rabies virus in research laboratories or vaccine production facilities (for continuous-risk category, see Table 1) should have a serum sample tested for rabies antibodies every 6 months. The minimum acceptable antibody level is complete virus neutralization at a 1:5 serum dilution by RFFIT. A booster dose should be administered if the titer falls below this level.
The frequent-risk category includes other laboratory workers such as those doing rabies diagnostic testing, spelunkers, veterinarians and staff, and animal-control and wildlife officers in areas where rabies is epizootic. Persons in the frequent-risk category should have a serum sample tested for rabies antibodies every 2 years and if the titer is less than complete neutralization at a 1:5 serum dilution by RFFIT should have a booster dose of vaccine. Alternatively, a booster can be administered in the absence of a titer determination.
The infrequent-risk category, including veterinarians, animal-control and wildlife officers working in areas of low rabies enzooticity (infrequent-exposure group), and international travelers to rabies enzootic areas, do not require routine preexposure booster doses of RabAvert after completion of a full primary preexposure vaccination scheme (Table 1).
Postexposure Dosage: Immunization should begin as soon as possible after exposure. A complete course of immunization consists of a total of 5 injections of 1 mL each: 1 injection on each of Days 0, 3, 7, 14, and 28 in conjunction with the administration of HRIG on Day 0. For children, see PRECAUTIONS: Pediatric Use.
Begin with the administration of HRIG. Give 20 IU/kg body weight.
This formula is applicable to all age groups, including infants and children. The recommended dosage of HRIG should not exceed 20 IU/kg body weight because it may otherwise interfere with active antibody production. Since vaccine-induced antibody appears within 1 week, HRIG is not indicated more than 7 days after initiating postexposure prophylaxis with RabAvert. If anatomically feasible, the FULL DOSE of HRIG should be thoroughly infiltrated in the area around and into the wounds. Any remaining volume of HRIG should be injected intramuscularly at a site distant from rabies vaccine administration. HRIG should never be administered in the same syringe or in the same anatomical site as the rabies vaccine.
Because the antibody response following the recommended immunization regimen with RabAvert has been satisfactory, routine post-immunization serologic testing is not recommended. Serologic testing is indicated in unusual circumstances, as when the patient is known to be immunosuppressed. Contact the appropriate state health department or CDC for recommendations.
Postexposure Prophylaxis of Previously Immunized Persons: When rabies exposure occurs in a previously vaccinated person, that person should receive 2 IM (deltoid) doses (1 mL each) of RabAvert: one immediately and one 3 days later. HRIG should not be given in these cases. Persons considered to have been immunized previously are those who received a complete preexposure vaccination or postexposure prophylaxis with RabAvert or other tissue culture vaccines or have been documented to have had a protective antibody response to another rabies vaccine. If the immune status of a previously vaccinated person is not known, full postexposure antirabies treatment (HRIG plus 5 doses of vaccine) is recommended. In such cases, if a protective titer can be demonstrated in a serum sample collected before vaccine is given, treatment can be discontinued after at least 2 doses of vaccine.
Instructions for Reconstituting RabAvert: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.
Needle application (these instructions apply to both the green and the orange needles):
The package contains a vial of freeze-dried vaccine, a syringe containing 1 mL of sterile diluent, a sterile needle for reconstitution, and a sterile needle suitable for IM injection. The longer of the 2 needles supplied is the reconstitution needle. Affix the reconstitution needle to the syringe containing the Sterile Diluent for RabAvert. Insert the needle at a 45° angle and slowly inject the entire contents of the diluent (1 mL) into the vaccine vial. Mix gently to avoid foaming. The white, freeze-dried vaccine dissolves to give a clear to slightly opalescent, colorless to slightly pink suspension. Withdraw the total amount of dissolved vaccine into the syringe and replace the long needle with the smaller needle for IM injection. The reconstituted vaccine should be used immediately.
A separate sterile syringe and needle should be used for each patient. Needles must not be recapped and should be disposed of properly.
The lyophilization of the vaccine is performed under reduced pressure and the subsequent closure of the vials is done under vacuum. If there is no negative pressure in the vial, injection of Sterile Diluent for RabAvert would lead to an excess positive pressure in the vial. After reconstitution of the vaccine, it is recommended to unscrew the syringe from the needle to eliminate the negative pressure. After that, the vaccine can be easily withdrawn from the vial. It is not recommended to induce excess pressure, since over-pressurization may prevent withdrawing the proper amount of the vaccine.
RabAvert product presentation is listed in Table 3.
Carton NDC Number
•1 vial of freeze-dried vaccine containing a single dose [NDC 50632-013-01]•1 disposable prefilled syringe of Sterile Diluent for reconstitution (1 mL) [NDC 50632-011-01]•1 small needle for injection (25 gauge, 1 inch) and 1 long needle for reconstitution (21 gauge, 1 ½ inch)
RabAvert should be stored protected from light at 2°C to 8°C (36°F to 46°F). After reconstitution, the vaccine is to be used immediately. The vaccine may not be used after the expiration date given on package and container.
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RabAvert is a trademark owned by Bavarian Nordic A/S.
Manufactured for Bavarian Nordic A/S,
DK-2900 Hellerup, Denmark (US License No. 2096)
by GSK Vaccines, GmbH, D-35006 Marburg, Germany
Distributed by Bavarian Nordic Inc.
3025 Carrington Mill Boulevard, Suite 100Morrisville NC 27560
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