Verorab is indicated for pre-exposure and post-exposure prophylaxis of rabies in all age groups (see
sections 4.2 and 5.1).
Verorab should be used according to official recommendations.
Pre-exposure prophylaxis should be offered to subjects at high risk of contamination by the rabies virus.
All those at permanent risk, such as the personnel of diagnostic, research or production laboratories
working on the rabies virus, should be vaccinated
Vaccination is also recommended for the following categories:
• chiropterologists and people regularly exposed to the bat rabies virus.
• exposed professionals (veterinary personnel, laboratory personnel handling equipment that is
contaminated or likely to be contaminated, slaughterhouse butchers, pound personnel, naturalists,
taxidermists, gamekeepers, forest rangers, slaughterhouse personnel).
• adults and children living in or travelling to enzootic areas.
Booster doses are determined based on the risk of exposure and on serological tests in accordance
with official recommendations.

Posology
The recommended dose is 0.5 mL of reconstituted vaccine.
Pre-exposure prophylaxis
Three doses of 0.5 mL of Verorab are administered by intramuscular route at days (D) D0, D7 and D28.
The dose scheduled at D28 can be administered at D21, if necessary.

Booster doses are determined based on the risk of exposure and on serological tests in accordance
with official recommendations.
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 prophylaxis
Post-exposure prophylaxis includes local non-specific treatment of the wound, vaccination and, where
appropriate, passive immunisation with rabies immunoglobulins.
Post-exposure prophylaxis should be initiated as soon as possible after suspected exposure to rabies.
In all cases, proper wound care (careful washing of all bites and scratches with soap or detergent and
copious amounts of water and/or virucidal agents) must be performed immediately or as soon as
possible after exposure. It must be performed before administration of vaccine or rabies
immunoglobulins, when they are indicated. Post-exposure prophylaxis should be adjusted to the
exposure category, the condition of the animal (see Table 2) and the vaccination status of the patient,
in accordance with official recommendations (see Table 1, WHO recommendations).
Post-exposure prophylaxis should be performed as soon as possible after exposure under medical
supervision and only at a rabies centre.
If necessary, post-exposure prophylaxis can be supplemented by tetanus prophylaxis and antibiotic
therapy to prevent the development of infections other than rabies.
Table 1: WHO Guide for post-exposure prophylaxis depending on severity of exposure (to be
adapted according to local official recommendations).

(a) If the animal is an apparently healthy dog or cat living in a low-risk area and placed under veterinary observation,
treatment may be postponed (see Table 2).
(b) This observation period only applies to cats and dogs. With the exception of endangered or threatened species,
domestic animals and wild animals suspected to have rabies should be euthanised and their tissues examined
using appropriate laboratory methods (see Table 2).
(c) Bites, particularly to the head, neck, face, hands and genitals are classified as Category III exposure due to the
extensive innervation of these parts of the body.
Table 2: Course of action after exposure depending on the condition of the animal (WHO
recommendations to be adapted according to local recommendations)

(a) In France, veterinary supervision includes 3 certificates, drawn up at 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 exposure: see Table 1.
Post-exposure prophylaxis of non-immunised subjects
• Essen regimen
The vaccine should be administered by intramuscular route at D0, D3, D7, D14 and D28 (5 injections of
0.5 mL).
Or
• Zagreb regimen (schedule 2-1-1)
The vaccine should be administered by intramuscular route: one dose in the right deltoid and one dose
in the left deltoid at D0, then one dose in the deltoid at D7 and one dose at D21 (4 injections of 0.5 mL).
In young children, the vaccine should be administered in the anterolateral region of the thigh muscle.
Whatever the regimen used, vaccination must not be discontinued unless the contact animal is declared
free from rabies after veterinary supervision (see Table 2).
Rabies immunoglobulins should be administered concomitantly with the vaccine, in case of category III
exposure (WHO classification, see Table 1). If possible, the vaccine should be administered
contralaterally to the immunoglobulin administration sites.
Refer to the Summary of Characteristics of the rabies immunoglobulins used.
Post-exposure prophylaxis for already immunised subjects
In accordance with official recommendations, this applies to subjects who have already received preexposure
prophylaxis or post-exposure prophylaxis or who discontinued post-exposure prophylaxis after
receiving at least two doses of vaccine prepared in cell culture.
Subjects who are already immunised should receive 1 dose of vaccine (0.5 mL by intramuscular route)
at D0 and 1 dose at D3.
Rabies immunoglobulins are not indicated in this case.

Immunocompromised subjects
• Pre-exposure prophylaxis
For immunocompromised subjects, a serological test for neutralising antibodies should be performed
2 to 4 weeks after vaccination to assess the need for an additional dose of vaccine.
• Post-exposure prophylaxis
For immunocompromised subjects, a complete vaccination schedule should be administered postexposure.
Rabies immunoglobulins should be administered concomitantly with the vaccine in the event
of any category II or III exposure (see Table 1).
Paediatric population
Children should receive the same dose as adults (0.5 mL by IM route).
Method of administration
Precautions to be taken before handling or administering the medicinal product
The vaccine is administered via the intramuscular route, in the anterolateral region of the thigh muscle
in infants and young children and in the deltoid muscle in older children and adults.
Do not inject in the buttocks region.
Do not inject via the intravascular route.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Special warnings
As with all vaccines, Verorab may not protect 100% of vaccinated individuals.
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 class.
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 section 4.2).
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 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’.
Paediatric population
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.

Immunosuppressive treatments, including long-term systemic corticosteroid therapy, may interfere with
the production of antibodies and lead to vaccination failure. It is therefore recommended to perform a
serological test 2 to 4 weeks after vaccination (see section 4.2).
Verorab may be administered concomitantly with a Vi polysaccharide typhoid vaccine during the same
vaccination visit, using two different injection sites.
Rabies immunoglobulins or any other product and the rabies vaccine must never be combined in the
same syringe or injected into the same site (see section 6.2).
Given that rabies immunoglobulins interfere with the development of the immune response to the rabies
vaccine, the recommendations for administration of rabies immunoglobulins should be strictly followed.

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 postnatal
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 fetotoxic effects to date.
Pre-exposure prophylaxis
Given the seriousness of the disease, in case of high risk of contamination, vaccination should be
performed during pregnancy, in compliance with the usual vaccination schedule.
Post-exposure prophylaxis
Given the seriousness of the disease, pregnancy is not a contraindication.
Lactation
This vaccine can be used during lactation.
Fertility
Verorab has not been evaluated in fertility studies.

Post-vaccination dizziness was frequently reported (see section 4.8). It can temporarily affect the ability
to drive or use machines.

Summary of the safety profile
Over 13,000 subjects, including approximately 1,000 children and adolescents under the age of 18,
have received at least one dose of Verorab in clinical studies.
Adverse reactions were generally moderate in intensity and occurred within 3 days of vaccination. Most
reactions resolved spontaneously within 1 to 3 days of their onset.
The most common adverse reactions, in all age groups (except infants/young children less than
24 months) were headache, malaise, myalgia and pain at the injection site.
Tabulated list of adverse reactions
The adverse reactions listed below were reported during clinical studies and worldwide post-marketing
surveillance. Within each system organ class, adverse reactions are ranked under headings of
frequency using the following convention:
• very common (≥ 1/10);
• common (≥ 1/100 and <1/10);
• uncommon (≥ 1/1,000 and <1/100);
• rare (≥ 1/10,000 and <1/1,000);
• very rare (<1/10,000);
• not known (cannot be estimated from the available data).

Reporting of suspected adverse reactions
To report any side effect(s):
• Saudi Arabia: The National Pharmacovigilance and Drug Safety Centre (NPC)
• SFDA call center : 19999 /E-mail: npc.drug@sfda.gov.sa / Website: https://ade.sfda.gov.sa/
• Sanofi- Pharmacovigilance: KSA_Pharmacovigilance@sanofi.com

No cases of overdose were reported. 

Pharmacotherapeutic group: Rabies vaccines, ATC code: J07BG.
Mechanism of action
Protection after vaccination is provided by the induction of anti-rabies neutralising antibodies.
Clinical studies have been conducted to assess the immunogenicity of the vaccine for pre-exposure
and post-exposure prophylaxis. A titre of anti-rabies neutralising antibodies ≥ 0.5 IU/mL is considered
protective.
Pre-exposure prophylaxis
In clinical trials assessing a 3-dose regimen (D0, D7, D28 (or D21) by IM route) in adults and children,
all subjects achieved an adequate immune response with anti-rabies neutralising antibody titres ≥ 0.5
IU/mL two weeks after the end of primary vaccination.
A ten-year follow-up in 49 subjects who received the vaccine according to a 3-dose schedule (D0, D7,
D28) followed by a booster dose one year later showed the persistence of the immune response with
anti-rabies neutralising antibody titres ≥ 0.5 IU/mL for up to 10 years in 96.9% of vaccinated subjects.
Post-exposure prophylaxis
In clinical trials assessing the 5-dose Essen regimen (D0, D3, D7, D14, D28 by IM route) and the 4-
dose Zagreb regimen (2 doses at D0, then 1 dose at D7 and 1 dose at D21 by IM route) in adults and
children, Verorab induced adequate titres of anti-rabies neutralising antibodies (≥ 0.5 IU/mL) in nearly
all subjects at D14 and in all subjects at D28.
The administration of human rabies immunoglobulin (HRIG) or equine rabies immunoglobulin (ERIG)
concomitantly with the rabies vaccine may cause slightly lower mean neutralising antibody titres due to
immune interference.
The effectiveness of Verorab was evaluated in 44 adult subjects bitten by animals confirmed to be
rabid. The subjects received the vaccine according to the 5-dose Essen regimen (D0, D3, D7, D14 and
D28 by IM route) and immunoglobulins, where necessary. Three years after vaccination, none of the
subjects had developed rabies.
Paediatric population
There are no clinically significant differences in the immunogenicity of the vaccine in the paediatric
population compared to adults.

No pharmacokinetic studies were performed.

Toxicity studies in animals (acute, subacute and chronic toxicity) do not indicate any toxic effects or
target organ toxicity.

Powder*:
Maltose.
20% human albumin solution.
Basal Medium Eagle: mixture of mineral salts (including potassium), vitamins, dextrose and amino acids
(including L-phenylalanine).
Hydrochloric acid and sodium hydroxide for pH adjustment.
Water for injections.
* Composition of the powder before the freeze-drying step.
Solvent:
Sodium chloride.
Water for injections.

Rabies immunoglobulins or any other product and the rabies vaccine must never be combined in the
same syringe or injected into the same site.
This medicinal product must not be mixed with other medicinal products or other vaccines.

Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original outer package, protected from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

Powder in vial (Type I glass) with a stopper (chlorobutyl) and a cap + 0.5 mL of solvent in prefilled
syringe (Type I glass) with a plunger-stopper (chlorobutyl or bromobutyl). Box of 1 or 10.

Handling instructions:
• Remove the cap of the vial of lyophilised powder.
• Screw the plunger rod into the syringe, if provided separately.
• Inject the solvent into the vial of lyophilised powder.
• Shake the vial gently until homogeneous suspension of the powder is obtained.
• The reconstituted vaccine should be limpid, homogeneous and free from particles.
• Remove and discard the syringe that was used for vaccine reconstitution.
• Use a new syringe with a new needle to withdraw the reconstituted vaccine.
• Replace the needle used to withdraw the vaccine by a new needle for intramuscular injection.

• The length of the needle used for vaccine administration should be adapted to the patient.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.