Special warnings: As with all vaccines, VERORAB may not protect 100% of people vaccinated.
Use with caution in people with known allergies to polymyxin B, to streptomycin, to neomycin (present as traces in the vaccine) or to any antibiotic of the same group.
Precautions for use: Injection-schedule recommendations should be followed scrupulously. Serological tests (assay of neutralizing antibodies using the RFFIT - Rapid Fluorescent Focus Inhibition Test - method) should be performed regularly (see Table 1).
When the vaccine is administered to subjects with a known immunodeficiency due to an immunosuppressive illness or a concomitant immunosuppressive treatment (such as corticosteroids), a serological test should be performed 2 to 4 weeks after vaccination (see Dosage & Administration).
Do not inject via the intravascular route: make sure the needle does not penetrate a blood vessel.
As with all injectable vaccines, appropriate medical treatment and supervision must be readily available in case of a rare anaphylactic reaction after vaccine administration, particularly in case of post-exposure in subjects with a known hypersensitivity to polymyxin B, to streptomycin, to neomycin or to any antibiotic of the same group.
As with all injectable vaccines, VERORAB should be administered with caution in subjects with thrombocytopenia or coagulation disorders as intramuscular injection may induce bleeding in these subjects.
The potential risk of apnoea and the need for respiratory monitoring for 48 - 72 hours should be considered when administering the primary immunization series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance and paraesthesia. It is important that procedures are in place to avoid injury from faints.
Additional Precautions related to ID route: It is essential that intradermal administration of VERORAB be carried out only by medical staff trained in this technique in order to ensure that the vaccine is delivered intradermally and not subcutaneously. For the intradermal route an appropriate graduated sterile syringe with needle (insulin type) should be used. Correct intradermal injection should result in a raised papule with an "orange peel" appearance.
If the vaccine is injected too deeply into the skin, and a papule is not seen, the needle should be withdrawn and reinserted nearby.
Effects on ability to drive and use machines: Post-vaccination dizziness was frequently reported (see Adverse Reactions). It can temporarily affect the ability to drive or use machines.