Verorab

/ Medici

One dose consists in the administration of 0.5 mL of vaccine via the intramuscular route.
The vaccination schedule should be adapted according to the circumstances of vaccination and the subject’s rabies immunity status
Pre-exposure vaccination: Three doses of 0.5 mL of VERORAB are administered at D0, D7 and D28 for primary vaccination. The dose scheduled at D28 can be administered at D21.
This administration schedule follows WHO recommendations.
Booster doses and regular serological tests, to assess the subjects’ seroconversion status, are recommended. The frequency of booster doses and tests is indicated in Table 1 at the attached doctor’s leaflet.
Each booster dose consists in the administration of one dose of 0.5 mL.
VERORAB can be administered as a booster injection after primary vaccination with a cell culture rabies vaccine (a rabies vaccine prepared in VERO cells or prepared in human diploid cells (HDCV)).
Post-exposure vaccination: Post-exposure treatment includes local non-specific treatment of the wound, vaccination and passive immunisation with rabies immunoglobulins if necessary. The treatment should be adapted to the nature of the contact or of the wound (see Table 2 at the attached doctor’s leaflet), the condition of the animal (see Table 3at the attached doctor’s leaflet ) and the patient’s rabies vaccination status.
First aid: local treatment of the wound
Local treatment of all bites and scratches is very important and must be performed immediately.
First aid recommendations include immediate flushing out of the wound for at least 15 minutes with water and soap, detergent, povidone iodine or any other substance with a proven destructive action on the rabies virus. If no soap or antiviral agents are available, the wound should be extensively flushed out with water.
If necessary, the treatment can be supplemented by the administration of a prophylactic tetanus treatment and an antibiotherapy in order to prevent the development of infections other than rabies.
Vaccination of non-immunised subjects (subjects who did not receive pre-exposure vaccination): Five doses of VERORAB (0.5 ml) should be administered on D0, D3, D7, D14 and D28.
Rabies immunoglobulins (RIGs) should be administered concomitantly with the first injection in the case of a severe injury (category III, according to the WHO rabies risk classification).
It can be administered later ,but not after the 7th day of vaccination.
Equine and human immunoglobulins can be used with VERORAB.
The internationally recognized RIG posology is as follows:
Human rabies immunoglobulins: 20 IU/kg of body weight
Equine rabies immunoglobulins: 40 IU/kg of body weight
Because RIGs may partially inhibit active antibody production, no more than the recommended dose should be administered.
The vaccine should be injected contralaterally to the RIG administration sites.
In enzootic rabies areas, the administration of two vaccine injections on D0 may be justified, e.g. in the case of lesions that are extremely severe or located near the nervous system, or when the subject is immunodeficient or did not come in for a medical consultation immediately after exposure.
VERORAB must not be discontinued unless made possible by the animal’s health status (see Table 3).
Rabies immunoglobulins should be administered at D0 concomitantly with the vaccine, in case of category III exposure (WHO classification, see Table 2). The rabies immunoglobulins posology is as follows :
-Human rabies immunoglobulins ……………………… 20 IU/kg of body weight,
-Equine rabies immunoglobulins ………………………. 40 IU/kg of body weight.
For more information, please see the Summary of Characteristics of the rabies immunoglobulins used.
When possible, the vaccine should be administered contra-laterally to the immunoglobulins administration sites.
For immunodeficient subjects in case of Category II exposure (WHO Classification, see Table 2), rabies immunoglobulins should also be administered concomitantly with the vaccine.
Vaccination of subjects already immunised (full pre-exposure vaccination confirmed).
If pre-exposure vaccination was performed less than 5 years before (cell culture rabies vaccine): two booster doses are administered at D0 and D3. Rabies immunoglobulins are not necessary.
If pre-exposure vaccination was performed more than 5 years before, if it is incomplete or in case of doubt, the subject’s vaccination status is not considered as complete and a full post-exposure treatment should be started (see “Vaccination of non-immunised subjects”).
If the patient is immunodeficient, a full post-exposure treatment should also be started (see “Vaccination of nonimmunised subjects”).
Paediatric population: VERORAB can be administered to children and to adults using the same posology.
Method of administration: Precautions to be taken before handling or administering the medicinal product.
The vaccine is administered via the intramuscular route, generally in the anterolateral region of the thigh muscle until the age of 12 months and in the deltoid muscle after this age.
Do not inject in the buttocks region.
Do not inject via the intravascular route.
See prescribing information for full details.

Prevention of rabies in children and adults. It can be used before and after exposure, as a primary vaccination or as a booster dose.

Pre-exposure vaccination: Hypersensitivity to the active substance or to any of the excipients, to polymyxin B, to streptomycin, to neomycin or to any antibiotic of the same group, to a previous administration or to any vaccine containing the same components.
Vaccination should be postponed in case of febrile or acute diseases.
Post-exposure vaccination: Given the fatal outcome of the declared rabies infection, there are no contraindications to post-exposure vaccination.

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.
Injection-schedule recommendations should be followed scrupulously.
Serological tests (assay of neutralising antibodies using the RFFIT – Rapid Fluorescent Focus Inhibition Test – method) should be performed regularly (see Table 1 at the attached doctor’s leaflet).
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.
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 h should be considered when administering the primary immunisation 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.

Experience from clinical trials
Blood and lymphatic system disorders:
Very common: adenopathy/lymphadenopathy.
Immune system disorders:
Common: cutaneous allergic reactions such as rash, pruritus, oedema.
Uncommon: urticaria, angioedema, dyspnoea.
Nervous system disorders:
Common: headache, dizziness, somnolence.
Gastrointestinal disorders:
Common: abdominal pain, nausea.
Uncommon: diarrhoea.
Musculoskeletal and connective tissue disorders:
Very common: myalgia.
Common: arthralgia, shivering.
General disorders and administration site conditions:
Very common: Injection-site pain, fever, malaise.
Common: injection-site erythema, injection-site pruritus, injection-site haematoma, injection-site induration, asthenia, influenza-like syndrome.
Uncommon: injection-site swelling.
Experience after commercial use
In addition to the list above, the following undesirable effects were reported. Their exact incidence cannot be calculated as they were spontaneously reported. However, given the number of doses sold, the occurrence of these undesirable effects is very rare (<1/10 000).
Immune system disorders: Anaphylactic reactions, serum sickness-like reactions.
Nervous system disorders: Encephalopathy, convulsions.
Ear and labyrinth disorders: Sudden hearing loss which may persist.
Respiratory, thoracic and mediastinal disorders: Apnoea in very premature infants (born ≤ 28 weeks of gestation).
Gastrointestinal disorders: Vomiting.

Corticosteroids and immunosuppressive treatments may interfere with the production of antibodies and lead to vaccination failure.
Rabies immunoglobulins and vaccine must never be combined in the same syringe or administered at the same site.
When possible, the vaccine should be administered contra-laterally to the immunoglobulins administration sites.

Pregnancy: One animal toxicity study on reproduction and development led with another inactivated rabies vaccine produced in VERO cells, did not evidence any deleterious effect on female fertility and on pre and post-natal development.
Clinical use of rabies vaccines (inactivated “WISTAR Rabies PM/WI38 1503-3M strain”) during a limited number of pregnancies did not show any malformative or foetotoxic effects to date.
Given the seriousness of the disease, vaccination should be performed during pregnancy, in compliance with the usual vaccination schedule, in case of high risk of contamination.
Lactation: This vaccine can be used during lactation.

No cases of overdose were reported.

Incompatibilities: The rabies immunoglobulins and the rabies vaccine must never be combined in the same syringe or injected at the same injection site.
This medicinal product must not be mixed with other medicinal products or other vaccines.
Shelf life: After reconstitution, the vaccine must be administered immediately.
Storage: Store in a refrigerator (2°C-8°C). Do not freeze.