To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.
Report an Adverse Event
To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.
Patients considered to be at risk of a severe hypersensitivity reaction (e.g. anaphylaxis) to RabAvert or any of its components should receive an alternative rabies vaccine...
RabAvert is indicated for pre-exposure vaccination, in both primary series and booster dose, and for post-exposure prophylaxis against rabies in all age groups.
if a suitable product is available. However, in view of the almost invariably fatal outcome of rabies, there is no contraindication to post-exposure prophylaxis, including pregnancy.
RabAvert is contraindicated for pre-exposure vaccination in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to the vaccine or any of its components, which include residues of egg and chicken proteins to which some individuals may be hypersensitive.
Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions, as well as medical history for emergence of clinical symptoms of anaphylaxis after exposure to egg or chicken proteins, which RabAvert contains. Reconstituted RabAvert also contains processed bovine gelatin and trace amounts of neomycin, chlortetracycline, and amphotericin B, to which some individuals may be hypersensitive. Appropriate medical treatment—including immediately available epinephrine injection (1:1,000), and readily available volume replacement, corticosteroids, and oxygen—must be close at hand to manage possible anaphylactic reactions following administration of RabAvert.
Anaphylaxis, meningitis; neuroparalytic events such as encephalitis, transient paralysis; Guillain-Barré Syndrome; myelitis; retrobulbar neuritis; and multiple sclerosis have in very rare cases been reported in temporal association with the use of RabAvert.
For intramuscular use only. Unintentional intravascular injection may result in systemic reactions, including shock.
Syncope (fainting) can occur in association with administration of injectable vaccines, including RabAvert. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
Development of active immunity after vaccination may be impaired in immune-compromised individuals. Radiation therapy, antimalarials, corticosteroids, other immunosuppressive agents, and immunosuppressive illnesses can interfere with the development of active immunity after vaccination and may diminish the protective efficacy of RabAvert. Pre-exposure vaccination should be administered to such persons with the awareness that the immune response may be inadequate. If persons receiving corticosteroids or other immunosuppressive therapy, or who are immunosuppressed, are vaccinated post-exposure, it is important that a serum sample on Day 14 (the day of the fourth vaccination) be tested for rabies antibody to ensure that an acceptable antibody response has been induced.
Pre-exposure vaccination should be postponed in the case of sick and convalescent persons and those considered to be in the incubation stage of an infectious disease.
This product contains albumin, a derivative of human blood. It is present in RabAvert at concentrations of ≤0.3 mg/dose. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeld-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
Administration of Human Rabies Immune Globulin (HRIG), which along with prompt local cleaning of wounds should take place before post-exposure prophylaxis, must not exceed the recommended dose, since active immunization to the vaccine may be impaired. HRIG should not be administered to previously vaccinated persons as it may blunt their rapid memory response to rabies antigen.
Because animal reproductive studies or studies in pregnant or lactating woman have not been conducted with RabAvert, it is not known whether RabAvert can cause fetal harm when administered to a pregnant woman, whether it can affect reproduction capacity, or whether it is excreted in animal or human milk with consequent risk to breastfed infants (but many drugs are excreted in human milk). Use RabAvert in pregnant or lactating women only if clearly needed.
No data are available regarding the concurrent administration of RabAvert with other vaccines.
The most commonly occurring adverse reactions in clinical trials of RabAvert, were injection site reactions, such as injection site erythema, induration, and pain; flu-like symptoms, such as asthenia, fatigue, fever, headache, myalgia, and malaise; arthralgia; dizziness; lymphadenopathy; nausea; and rash.
Pre-exposure vaccination does not eliminate the need for additional therapy after a known rabies exposure.
To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.