Verorab PDF
Verorab PDF
Verorab PDF
: 1C 339/47
Importer / Manufacturer: Sanofi Pasteur Ltd., Thailand/Sanofi Pasteur S.A., France
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICAL PRODUCT : VERORAB
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is rabies virus*, Wistar Rabies PM/WI38 1503-3M strain (inactivated) ( 2.5
IU**/0.5 ml)
* produced on VERO cells
** quantity measured according to the international standard and the NIH test (National Institute of
Health test)
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
VERORAB comes in the form of a powder and solvent for suspension for injection (1 dose of powder
in a vial and 0.5 ml of solvent in a prefilled syringe. Box of 1).
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
It is indicated for the prevention of rabies in children and adults. It can be used before or after
exposure, as a primary vaccination or as a booster dose.
Pre-Exposure Prevention of Rabies (Pre-Exposure Vaccination):
Pre-exposure vaccination should be offered to subjects at high risk of contamination by the rabies
virus. All those at permanent risk, such as the personnel of a diagnostic, research or production
laboratory working with the rabies virus, should be vaccinated.
A serological test is recommended every 6 months in people at permanent risk of exposure and every 2
to 3 years after each booster injection in subjects at discontinuous risk of exposure. If the antibody
level is under that considered to be protective, i.e. 0.5 IU/ml (RFFIT), a booster injection should be
administered. These serological tests are performed by verifying the complete neutralisation of a
reference virus, by the RFFIT method (Rapid Fluorescent Focus Inhibition Test) (see "Take Special
Care with VERORAB")
Pre-exposure vaccination should also be considered for subjects at frequent risk of exposure to the
rabies virus, such as:
- Veterinarians and their assistants, animal handlers.
- Those who, either by profession or leisure activity, are in contact with species such as dogs, cats,
skunks, raccoons, bats or other species likely to have rabies. Examples of such people are
gamekeepers, hunters, forestry workers, speleologists and taxidermists.
- Adults and children living or travelling in enzootic areas.
In areas where the enzootic level of rabies is low, veterinarians and assistants (including students),
animal handlers and wildlife officers (gamekeepers) are considered to be at occasional risk of exposure
and should receive a primary vaccination against rabies.
Serological tests for rabies antibodies should be performed at regular intervals in accordance with the
subjects risk exposure.
Systematic booster injections should be administered in accordance with the subjects risk exposure.
Post-Exposure Prevention of Rabies (Post-Exposure Vaccination):
At the slightest risk of contamination, post-exposure vaccination should be performed as soon as
possible.
In some countries, vaccination must be performed in a specialized rabies treatment centre.
Post-exposure treatment includes local, non-specific treatment of the injury, passive immunisation
with rabies immunoglobulins (RIGs) and vaccination, depending on the type of injury and the status of
the animal (see Tables 1 and 2).
Table 1 : Course of Action Depending on the Status of the Animal
Circumstances
Animal unavailable
Suspect or nonsuspect
circumstances
Comments
The patient
To be taken to a rabies
treatment centre for
treatment
To be taken to a rabies
treatment centre for
treatment
Place under
veterinary
supervision(a)
Suspect
circumstances
Place under
veterinary
supervision(a)
To be taken to a rabies
treatment centre for
treatment
Treatment(b) is discontinued if
veterinary supervision invalidates
the initial doubts, or, otherwise,
continued
(a) In France, veterinary supervision includes 3 certificates drawn up on D0, D7, and D14
declaring the absence of signs of rabies. According to WHO recommendations, the minimum
observation period under veterinary supervision for dogs and cats is 10 days.
(b) Treatment is recommended depending on the severity of the wound : see Table below.
Category of
severity
Recommended treatment
II
III
(a) Contact with rodents, rabbits, or hares does not normally necessitate specific rabies treatment.
(b) Discontinue treatment if the animal is in good health after 10 days of observation (for cats and
dogs) or if after the animal has been euthanized, the results of the search for rabies by the
appropriate laboratory techniques are negative.
222011 known as original Thai Red Cross Regimen prescribes 1 injection of 0.1 ml at different
sites on D0,D3,D7 and 1 injection at one site on D28 (or D30) and D90
22202 known as updated Thai Red Cross regimen prescribes 1 injection of 0.1 mL at 2 sites on D
0, D3, D7, and D28.
4.3 Contraindication
Do not use VERORAB:
Pre-Exposure
If you have a fever or an acute illness: vaccination should be postponed.
If you are allergic to the active substance, to one of the excipients, to polymyxine B, to streptomycin or
to neomycin.
Post-Exposure
Because rabies is always fatal, there is no contraindication to post-exposure vaccination.
BEFORE YOU USE VERORAB Intradermal route
Do not use VERORAB Intradermal route (Pre-Exposure and Post-exposure vaccination):
The Intradermal route must not be used in the following instances:
- individuals receiving long term corticosteroid or other immunosuppressive therapy or anti-malarial
chemoprophylaxis
- immunocompromised individuals,
- individuals, particularly children, with severe wounds, especially to the head and neck or
presenting late for consultation.
If the vaccine is injected too deeply into the skin, and a papule is not seen, the needle should be
withdrawn and reinserted nearby. If there is a complete failure to inject intradermally at more than half
of the multiple injection sites, an extra intradermal dose should be given in the opposite site.
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
3 years