Vaccine Information: RabAvert (Page 3 of 3)

DOSAGE AND ADMINISTRATION

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.

diagram of vial
(click image for full-size original)

Step 1: With one hand, hold the syringe (E) with the cap pointing upward. Be sure to hold the syringe by the white textured holding ring (D).

Step 1.jpg

Step 2: With the other hand, grasp the cap (A) and firmly rock it back and forth to break its connection to the white textured holding ring (D). Do not twist or turn the cap.

Step 2

Step 3: Lift up to remove the cap (A) and the attached gray tip cap (B). Be careful not to touch the sterile syringe tip (C).

Step3.jpg

Needle application (these instructions apply to both the green and the orange needles):

Step 1: Twist to remove the cap from the green reconstitution needle. Do not remove the plastic cover (G). This needle is the longer of the two needles.

Needle Step 1.jpg

Step 2: With one hand, firmly hold syringe (E) by white textured holding ring (D). With your other hand, insert needle (F) and twist clockwise until it locks into place. Once needle is locked, remove its plastic cover (G).

The syringe (E) is now ready for use.

Needle Step 2.jpg

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.

HOW SUPPLIED

RabAvert product presentation is listed in Table 3.

Table 3. RabAvert Product Presentation

Presentation

Carton NDC Number

Components

Single-dose kit

58160-964-12

1 vial of freeze-dried vaccine containing a single dose [NDC 58160-966-01]
1 disposable prefilled syringe of Sterile Diluent for reconstitution (1 mL) [NDC 58160-967-02]
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.

REFERENCES

1.
CDC. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Human Rabies Prevention – United States, 1999. Morbidity and Mortality Weekly Report Recommendations and Report, January 8, 1999, Vol.48, RR-1; 1.1-21.
2.
Smith JS, Yager, PA & Baer, GM. A rapid reproducible test for determining rabies neutralizing antibody. Bull WHO. 1973; 48: 535-541.
3.
Eighth Report of the WHO Expert Committee on Rabies. WHO Technical Report Series, no. 824; 1992.
4.
Dreesen DW, et al. Two-year comparative trial on the immunogenicity and adverse effects of purified chick embryo cell rabies vaccine for preexposure immunization. Vaccine. 1989; 7: 397-400.
5.
Dreesen, DW. Investigation of antibody response to purified chick embryo cell tissue culture vaccine (PCECV) or human diploid cell culture vaccine (HDCV) in healthy volunteers. Study synopsis 7USA401RA, September 1996 – December 1996 (unpublished).
6.
Nicholson KG, et al. Preexposure studies with purified chick embryo cell culture rabies vaccine and human diploid cell vaccine: serological and clinical responses in man. Vaccine. 1987; 5: 208-210.
7.
Vodopija I, et al. An evaluation of second generation tissue culture rabies vaccines for use in man: a four-vaccine comparative immunogenicity study using a preexposure vaccination schedule and an abbreviated 2-1-1 postexposure schedule. Vaccine. 1986; 4: 245-248.
8.
Wasi C, et al. Purified chick embryo cell rabies vaccine (letter). Lancet. 1986; 1: 40.
9.
Wasi C. Rabies prophylaxis with purified chick embryo (PCEC) rabies vaccine. Protocol 8T–201RA, 1983 — 1984 (unpublished).
10.
Wasi C. Personal communication to Behringwerke AG, 1990.
11.
Bijok U, et al. Clinical trials in healthy volunteers with the new purified chick embryo cell rabies vaccine for man. J Commun Dis. 1984; 16: 61-69.
12.
Lumbiganon P, et al. Preexposure vaccination with purified chick embryo cell rabies vaccines in children. Asian Pacific J Allergy Immunol. 1989; 7: 99-101.
13.
Vodopija I. Post-exposure rabies prophylaxis with purified chick embryo cell (PCEC) rabies vaccine. Protocol 7YU-201RA, 1983-1985 (unpublished).
14.
John J. Evaluation of purified chick embryo cell culture (PCEC) rabies vaccine, 1987 (unpublished).
15.
Tanphaichitra D, Siristonpun Y. Study of the efficacy of a purified chick embryo cell vaccine in patients bitten by rabid animals. Intern Med. 1987; 3: 158-160.
16.
Thongcharoen P, et al. Effectiveness of new economical schedule of rabies postexposure prophylaxis using purified chick embryo cell tissue culture rabies vaccine. Protocol 7T–301IP, 1993 (unpublished).
17.
Ljubicic M, et al. Efficacy of PCEC vaccines in post-exposure rabies prophylaxis. In: Vodopija, Nicholson, Smerdel & Bijok (eds.): Improvements in rabies post-exposure treatment (Proceedings of a meeting in Dubrovnik, Yogoslavia). Zagreb Institute of Public Health 1985.17.
18.
Madhusudana SN, Tripathi KK. Post exposure studies with human diploid cell rabies vaccine and purified chick embryo cell vaccine: Comparative Serological Responses in Man. Zbl Bakt 1989; 271: 345-350.
19.
Sehgal S, et al. Ten year longitudinal study of efficacy and safety of purified chick embryo cell vaccine for pre- and postexposure prophylaxis of rabies in Indian population. J Commun Dis. 1995; 27: 36-43.
20.
Sehgal S, et al. Clinical evaluation of purified chick embryo cell antirabies vaccine for postexposure treatment. J Commun Dis. 1988; 20: 293-300.
21.
Fishbein DB, et al. Administration of human diploid-cell rabies vaccine in the gluteal area. N Engl J Med. 1988; 318: 124-125.
22.
Shill M, et al. Fatal rabies encephalitis despite appropriate postexposure prophylaxis. A case report. N Engl J Med. 1987; 316: 1257-1258.
23.
Wilde H, et al. Failure of rabies postexposure treatment in Thailand. Vaccine. 1989; 7: 49-52.
24.
Kuwert EK, et al. postexposure use of human diploid cell culture rabies vaccine. Dev Biol Stand. 1977; 37: 273-286.
25.
Hemachudha T, et al. Additional reports of failure to respond to treatment after rabies exposure in Thailand. Clin Infect Dis. 1999; 28: 143-144.
26.
Lumbiganon P, Wasi C. Survival after rabies immunisation in newborn infant of affected mother. Lancet. 1990; 336: 319-320.
27.
Centers for Disease Control and Prevention. Health Information for International Travel, 2003-2004 (The Yellow Book). Atlanta: US Department of Health and Human Services, Public Health Service, 2003. Internet version at: http://www.cdc.gov/travel/yb
28.
World Health Organization. International Travel and Health, 2002. Geneva, Switzerland. Internet version at: http://www.who.int/ith
29.
CDC and NIH. Biosafety in microbiological and biomedical laboratories. 3rd. ed. Washington, D.C. HHS Publication no. (CDC) 93-8395, Washington, DC: US Department of Health and Human Services, 1993.
30.
Krebs JW, et al. Rabies surveillance in the United States in 2001. J Am Vet Med Assoc. 2002; 221: 1690-1701.

RabAvert is a trademark owned by or licensed to the GSK group of companies.

Manufactured by:
GSK Vaccines, GmbH,
D-35006 Marburg, Germany
US License No. 1617

Distributed by:
GlaxoSmithKline

Research Triangle Park, NC 27709

©2019 GSK group of companies or its licensor.

RAB:5PI

Rev. 9/2019

PRINICPAL DISPLAY PANEL

NDC 58160-964-12

Rabies Vaccine

RABAVERT

Rx Only

Indicated for All Age Groups

Single-dose freeze dried vaccine

Pre- and post-exposure intramuscular immunization only

Made in Germany

©2019 GSK group of companies or its licensor.

497954 Rev. 9/19
Rabavert carton
(click image for full-size original)

VIAL LABEL

NDC 58160-966-01

490715

Rabavert vial label
(click image for full-size original)

PRE-FILLED SYRINGE OF STERILE DILUENT LABEL

NDC 58160-967-02

490714

Sterile Diluent 1ml label
(click image for full-size original)
RABAVERT
rabies vaccine kit
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-964
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-964-12 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 1 mL
Part 2 1 SYRINGE 1 mL
Part 1 of 2
RABAVERT
rabies vaccine powder, for suspension
Product Information
Item Code (Source) NDC:58160-966
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED) (RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED)) RABIES VIRUS STRAIN FLURY LEP ANTIGEN (PROPIOLACTONE INACTIVATED) 2.5 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Tromethamine
Sodium chloride
EDETATE DISODIUM
POTASSIUM GLUCONATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-966-01 1 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103334 12/19/2016
Part 2 of 2
STERILE DILUENT
sterile diluent injection
Product Information
Item Code (Source) NDC:58160-967
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-967-02 1 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103334 12/19/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103334 12/19/2016
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 09/2019 GlaxoSmithKline Biologicals SA

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