Verorab Special Precautions

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.
The need for serological tests (to assess seroconversion in subjects)) should be determined in accordance with official recommendations.
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 to ensure that an immune response indicative of protection has been induced. In the case of post-exposure vaccination, all vaccine doses should be administered.
Rabies immunoglobulins should also be administered concomitantly with the vaccine in the event of any category II or III exposure (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 class.
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.
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.
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Verorab contains phenylalanine, potassium and sodium: Verorab contains 41 micrograms phenylalanine per 0.5 mL dose which is equivalent to 0.68 microgram/kg for a 60 kg person. Phenylalanine may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Verorab contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium (23 mg) per dose, that is to say essentially 'potassium-free' and 'sodium-free'.
Latex: The tip caps of the pre-filled syringes without needle contain a natural rubber latex derivative, which may cause allergic reactions in latex sensitive individuals.
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 Section 4.8). It can temporarily affect the ability to drive or use machines.
Use in children: The potential risk of apnoea with the need for respiratory monitoring for 48-72 h must be carefully taken into account when administering the primary vaccination doses in very premature infants (born at 28 weeks' gestation or less) and particularly in those with a history of respiratory immaturity.