Drug Detail:Imovax rabies (human diploid cell) (Rabies vaccine (human diploid cell) [ ray-beez-vax-een ])
Generic Name: RABIES VIRUS STRAIN PM-1503-3M ANTIGEN
Dosage Form: intramuscular injection kit
Drug Class: Viral vaccines
The package contains a vial of freeze-dried vaccine, a Luer-Lok™ syringe containing 1.0 mL of diluent with a plunger rod either inserted into the syringe or provided separately, and a sterile reconstitution needle. The syringe and its package should be inspected prior to use for evidence of leakage, premature activation of the plunger rod, or a faulty tip seal. If evidence of such defects is observed, the product should not be used.
Instructions for vaccine reconstitution
Luer-Lok™ syringe components (with plunger rod inserted)
Step 1: Remove plastic cover from the vial. Cleanse the vial stopper with a suitable germicide. Do not remove the stopper or the metal seal holding it in place.
Step 2: Screw the plunger rod into the syringe, if it is provided separately.
| Step 3: Hold the syringe cap in one hand (avoid holding the plunger rod or syringe barrel), and unscrew the tip cap by twisting it counterclockwise. |  |
| Step 4: Attach the reconstitution needle to the syringe, by gently twisting the needle clockwise into the syringe until slight resistance is felt. |  |
Step 5: Reconstitute the freeze-dried vaccine by injecting the diluent from the syringe into the vial. While the syringe and reconstitution needle are still attached, gently swirl the contents of the vial until completely dissolved and proceed to Step 6.
Step 6: Prior to withdrawing vial contents and without removing the reconstitution needle from the vial, unscrew the syringe to eliminate negative pressure (as the vial is sealed under vacuum). Reattach the syringe to the reconstitution needle which has remained in the vial.
Step 7: Withdraw the total contents of the vial into the syringe. Remove the reconstitution needle and discard it.
Step 8: Attach a new sterile needle (as per step 4) of a proper length and gauge suitable for intramuscular injection.
The supplied syringe is intended for single use only, must not be reused, and must be disposed of properly and promptly following its use.
To help avoid transmission of infectious diseases due to accidental needle sticks, needles should not be recapped but disposed of according to recommended guidelines.
The reconstituted vaccine should not be mixed with any other vaccine and should be used immediately.
Vaccine administration
Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. If evidence of such defects is observed, the product should not be used.
After preparation of the injection site with an appropriate germicide, immediately inject the vaccine intramuscularly. For adults and older children, the vaccine should be injected into the deltoid muscle. (10) (18) (19) In infants and small children, the anterolateral aspect of the thigh may be preferable, depending on age and body mass. Care should be taken to avoid injection into or near blood vessels and nerves. 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.
The gluteal area should not be used for administration of the vaccine as administration in this area may result in lower neutralizing antibody titers. (11)
NOTE: The freeze-dried vaccine is creamy white to orange. After reconstitution, it is pink to red.
Dosage schedules
A. Pre-exposure dosage
Primary vaccination
In the United States, the Advisory Committee on Immunization Practices (ACIP) recommends three injections of 1.0 mL each, one injection on Day 0, one on Day 7, and one either on Day 21 or 28. (11)
Booster dose
A booster dose consists of one injection of 1.0 mL of Imovax Rabies vaccine. To ensure the presence of a primed immune response over time among persons at higher than normal risk for exposure, titers should be checked periodically, with booster doses administered only as needed. Persons working with live rabies virus in research laboratories and in vaccine production facilities (continuous risk category) should have rabies antibody titers checked every six months and boosters given as needed to maintain an adequate titer defined as virus neutralization at a 1:5 dilution by a RFFIT. Other laboratory workers (eg, those performing rabies diagnostic testing), cavers, veterinarians and staff, animal-control and wildlife officers in areas where rabies is enzootic, and bat handlers regardless of location, (frequent risk category), should have their serum tested for rabies antibody every 2 years. If their titer is inadequate, they should receive a single booster dose of vaccine. Veterinarians, veterinary students, and terrestrial animal-control and wildlife officers, working in areas of low rabies endemicity (infrequent risk category) and certain at-risk international travelers who have completed a full pre-exposure vaccination series with licensed vaccines and according to schedule do not require routine booster serologic verification of detectable antibody titers or routine pre-exposure booster doses of vaccine (see Table 1). (11)
Persons who have experienced "immune complex-like" hypersensitivity reactions should receive no further doses of Imovax Rabies vaccine unless they are exposed to rabies or they are truly likely to be inapparently and/or unavoidably exposed to rabies virus and have unsatisfactory antibody titers.
B. Post-exposure dosage
Post-exposure dosage for previously unimmunized persons
Dose
Previously unvaccinated persons should receive 5 intramuscular doses (1 mL each) of Imovax Rabies vaccine, one dose immediately after exposure (Day 0) and one dose 3, 7, 14, and 28 days later.
RIG
Rabies immune globulin (RIG) 20 IU/kg on Day 0 in conjunction with the first vaccine dose. If possible, the full calculated dose of RIG should be used to infiltrate the wound(s). If it is not possible to do so, any remaining portion of the dose should be administered intramuscularly at a site different from the site used to administer the vaccine.
Because the antibody response following the recommended vaccination regimen with HDCV has been satisfactory, routine post-vaccination serologic testing is not recommended. Serologic testing is indicated in unusual circumstances, as when the patient is known to be immunosuppressed. Contact local or state health department or CDC for recommendations. (11)
Post-exposure dosage for previously immunized persons
When an immunized person who was vaccinated using the recommended pre-exposure regimen or a prior post-exposure regimen with a cell culture vaccine or who had previously demonstrated rabies antibody is exposed to rabies, that person should receive two intramuscular doses (1.0 mL each) of Imovax Rabies vaccine, one dose immediately after the exposure and one dose 3 days later. RIG should not be given in these cases.
If the immune status of a previously vaccinated person who did not receive the recommended HDCV regimen is not known, full primary post-exposure antirabies treatment (RIG plus 5 doses of HDCV) may be necessary. In such cases, if antibody levels of greater than 1:5 dilution by a RFFIT can be demonstrated in a serum sample collected before vaccine is given, treatment can be discontinued after at least two doses of HDCV. (20)
