Verorab

Package Leaflet: Information for the User

VERORAB,powder and solvent for suspension for injection
Rabies vaccine for human use, produced in cell cultures

Read the package leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for a specific person. Do not pass it on to others. This vaccine may harm another person.
• If the patient experiences any side effects, including any not listed in this leaflet, he/she should inform the doctor. See section 4.

Table of Contents of the Leaflet

• 1. What is VERORAB vaccine and what is it used for
• 2. Important information before using VERORAB vaccine
• 3. How to use VERORAB vaccine
• 4. Possible side effects
• 5. How to store VERORAB vaccine
• 6. Contents of the pack and other information

1. What is VERORAB vaccine and what is it used for

VERORAB vaccine is indicated for the prevention of rabies before and after exposure to rabies virus in all age groups.

Pre-exposure Prophylaxis (Pre-exposure Vaccination)

Pre-exposure vaccination should be offered to individuals at high risk of rabies virus infection.
These include laboratory staff working with rabies virus, and individuals who are frequently exposed to the risk of infection.
Immunity should be maintained through booster doses (see "Dosage").
Vaccination is also recommended for the following groups, taking into account the frequency of exposure to the risk of infection:

• Veterinarians and their assistants, animal handlers (including those in contact with bats) and hunters, and animal preparators,
• Individuals in contact with potentially rabid animals (such as dogs, cats, skunks, raccoons, bats),
• Adults and children traveling to or living in areas where there is a risk of rabies infection.

2. Important information before using VERORAB vaccine

Contraindications:

Pre-exposure Vaccination

• If the patient is allergic to the vaccine or any of the other ingredients of this vaccine (listed in section 6),
• If an allergic reaction occurred after previous administration of VERORAB vaccine or any other vaccine with the same composition,
• If the patient has a fever or acute illness (in which case vaccination should be postponed).

Post-exposure Prophylaxis

• Given that confirmed rabies infection is fatal, there are no contraindications to post-exposure prophylaxis.

Special Warnings and Precautions

• As with all vaccines, VERORAB may not protect 100% of vaccinated individuals.
• VERORAB vaccine should not be administered intravascularly; it should be ensured that the needle does not enter a blood vessel.
• Caution should be exercised in individuals with an allergy to polymyxin B, streptomycin, neomycin (present in the vaccine in trace amounts) or other antibiotics of the same group.
• If the vaccine is administered to individuals with known immunosuppression due to disease or treatment, a serological test should be performed 2 to 4 weeks after vaccination, see "Special Warnings and Precautions".
• VERORAB vaccine should be administered with caution in individuals with low platelet count (thrombocytopenia) or coagulation disorders, due to the risk of bleeding that may occur after intramuscular injection.

VERORAB vaccine contains phenylalanine, potassium, and sodium

• VERORAB vaccine contains 4.1 micrograms of phenylalanine per 0.5 ml dose, which corresponds to 0.068 micrograms/kg for a 60 kg person. Phenylalanine may be harmful in patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
• VERORAB vaccine contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, i.e., the vaccine is considered "potassium-free" and "sodium-free".

VERORAB vaccine and other medicines

Immunosuppressive drugs, including prolonged systemic corticosteroid therapy, may adversely affect antibody production and render vaccination ineffective.
Therefore, it is recommended to perform a serological test 2 to 4 weeks after the last vaccination, see "Special Warnings and Precautions".
Adults and children may receive VERORAB vaccine at the same time as typhoid vaccine. These vaccines must be administered at different injection sites and must not be mixed in the same syringe.
In the event of concomitant administration with any other medicinal product, including rabies immunoglobulin, vaccination should be performed at different sites and separate syringes should be used.
Since rabies immunoglobulin affects the development of the immune response to the vaccine, the recommendations for the administration of rabies immunoglobulin should be strictly followed.
The patient should inform the doctor about all medicines being taken currently or recently, as well as any medicines planned to be taken.

Pregnancy, Breast-feeding, and Fertility

Pregnancy

One toxicity study in animals performed with another inactivated rabies vaccine (VERORABVAX) did not show any adverse effects on female fertility or fetal development.
Clinical use of rabies vaccines (inactivated "WISTAR Rabies PM/WI38 1503-3M" strain) in a small number of pregnant women did not show any teratogenic or toxic effects on the fetus.
Given the severe course of the disease, in the event of a high risk of infection, vaccination during pregnancy should be performed according to the recommended vaccination schedule.

Breast-feeding

This vaccine can be used during breast-feeding.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, she should consult her doctor before using this vaccine.

Fertility

The vaccine has not been evaluated for its potential to impair fertility in males or females.

Driving and Using Machines

After vaccination, dizziness is often reported, which may temporarily affect the ability to drive and use machines.

3. How to use VERORAB vaccine

This vaccine should always be used in accordance with the doctor's recommendations. In case of doubt, consult a doctor or pharmacist.

Dosage

The recommended dose for intramuscular (im) administration is 0.5 ml of the vaccine after reconstitution.
The recommended dose for intradermal (id) administration is 0.1 ml of the vaccine after reconstitution at each injection site.
VERORAB can be administered to children and adults in the same doses.
Pre-exposure Prophylaxis
In the context of pre-exposure vaccination, patients may receive the vaccine according to one of the vaccination schedules presented in Table 1 and in accordance with official local recommendations, if available.

Table 1: Pre-exposure Vaccination Schedule

Day 0 Day 7 Day 21 or 28

Intramuscular administration (0.5 ml dose)
Traditional schedule
Intramuscular administration - 0.5 ml
1 dose
1 dose
1 dose
Weekly schedule
Intramuscular administration - 0.5 ml
1 dose
1 dose
Intradermal administration (0.1 ml dose)
Weekly schedule
Intradermal administration - 0.1 ml
2 doses
2 doses
Post-exposure Prophylaxis
Post-exposure prophylaxis should be initiated as soon as possible after suspected contact with the rabies virus.
In all cases, the wound should be immediately and thoroughly cleaned with soap and water and (or) a virucidal agent, before administration of the rabies vaccine or rabies immunoglobulin, if indicated.
The rabies vaccine should be administered strictly according to the degree of exposure (exposure category), the patient's immune status, and the animal's rabies status (in accordance with official local recommendations, see Table 2 with WHO recommendations).
Post-exposure prophylaxis must be performed under medical supervision, in a specialized center, and as soon as possible after exposure.
If necessary, treatment may be supplemented with tetanus prophylaxis and antibiotic therapy to prevent infection other than rabies.

Table 2: Exposure Categories According to WHO

a If the dog or cat comes from or has been in an area with low risk of rabies infection and shows no signs of illness and is under observation, treatment may be postponed.
b This observation period only applies to dogs and cats. With the exception of endangered species, other domestic or wild animals suspected of having rabies should be euthanized and their tissues examined for the presence of rabies antigen using appropriate laboratory techniques.
c Bites, particularly to the face, neck, head, hands, and genitals, are classified as category III due to the high density of nerve endings in these areas.

Table 3: Procedure Depending on the Animal's Status

In France, during veterinary observation, 3 certificates are issued - on days 0, 7, and 14 of observation - attesting to the absence of rabies symptoms.
According to WHO recommendations, the minimum observation period for dogs and cats is 10 days.
Treatment is recommended based on the severity of the wound: see Table 2
Post-exposure prophylaxis for previously unvaccinated individuals

• Essen scheme - the vaccine is administered on days 0, 3, 7, 14, and 28 (a total of 5 injections of 0.5 ml each) or
• Zagreb scheme (2-1-1 scheme) On day 0, one dose of vaccine is administered in the right deltoid muscle and one dose in the left deltoid muscle, then on days 7 and 21, one dose is administered in the deltoid region (a total of 4 injections of 0.5 ml each). In small children, the vaccine is administered in the anterolateral thigh.

In the case of category III exposure (see Table 2), rabies immunoglobulin should be administered simultaneously with the vaccine. If possible, the vaccine should be administered at a different site, on the opposite side of the body.
For further information, see the Summary of Product Characteristics of the rabies immunoglobulin used.
Vaccination should not be interrupted unless the veterinarian (animal observation and/or laboratory analysis) determines that the animal does not have rabies.
Post-exposure prophylaxis for previously vaccinated individuals
According to WHO recommendations, previously vaccinated individuals are patients who can document complete previous pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) and individuals who have interrupted the PEP series after at least two doses of rabies vaccine grown on cell lines.
Previously vaccinated individuals should receive one dose of vaccine intramuscularly on days 0 and 3. Rabies immunoglobulin is not indicated for these individuals.

Use in Individuals with Impaired Immune Function

• Pre-exposure Prophylaxis In individuals with impaired immune function, the traditional 3-dose vaccination schedule (presented in the "Pre-exposure Prophylaxis" subsection) should be used, and a serological test for neutralizing antibodies should be performed 2 to 4 weeks after the last dose to confirm the potential need for an additional dose of vaccine.
• Post-exposure Prophylaxis In individuals with impaired immune function, only the complete vaccination schedule (listed in the "Post-exposure Prophylaxis for Previously Unvaccinated Individuals" subsection) should be used. Rabies immunoglobulin should be administered in combination with the vaccine for two exposure categories: II and III (see Table 2).

Children and Adolescents

In children and adolescents, the same dose should be used as in adults (0.5 ml intramuscularly or 0.1 ml intradermally).

Method of Administration

• Intramuscular administration (im) The vaccine is administered in the anterolateral thigh in infants and small children and in the deltoid muscle in older children and adults.
• Intradermal administration (id) The vaccine is best administered in the upper arm or forearm.

If the Zagreb scheme is used, on day 0, one dose should be administered in each deltoid muscle (left and right) and then one dose on days 7 and 21.
VERORAB vaccine should not be administered in the gluteal area.
The vaccine should not be administered intravascularly.

Use of a Higher Than Recommended Dose of VERORAB Vaccine

Not applicable.

Missed Dose of VERORAB Vaccine

The doctor will decide when to administer the missed dose.

Discontinuation of VERORAB Vaccine

Not applicable.

4. Possible Side Effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Severe Allergic Reactions:

Severe allergic reactions (anaphylactic reactions) can occur, although they are very rare. If the patient or child experiences an anaphylactic reaction, they should immediately contact a doctor or a medical professional or go to the nearest hospital emergency department.
Symptoms of an anaphylactic reaction usually appear very quickly after injection and may include rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, tongue, or throat.

Other Side Effects:

Most side effects occur within 3 days of vaccination and resolve spontaneously within 1 to 3 days of their onset. They have been reported with the following frequency:

• Very common: may affect more than 1 in 10 people
• General malaise
• Headache
• Muscle pain
• Pain at the injection site
• Redness at the injection site
• Swelling at the injection site
• Only in infants - irritability, unconsolable crying, drowsiness

Common: may affect up to 1 in 10 people

• Fever
• Enlarged lymph nodes
• Allergic reactions, such as rash and itching
• Flu-like symptoms
• Itching at the injection site
• Induration at the injection site
• Only in infants - difficulty sleeping

Uncommon: may affect up to 1 in 100 people

• Decreased appetite
• Nausea
• Abdominal pain
• Diarrhea
• Vomiting
• Chills
• Fatigue, unusual weakness
• Dizziness
• Joint pain
• Bruising at the injection site

Rare: may affect up to 1 in 1,000 people

• Breathing difficulties

Frequency not known: frequency cannot be estimated from the available data

• Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing
• Sudden sensorineural hearing loss

Reporting of Side Effects

If side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store VERORAB Vaccine

Keep out of sight and reach of children.
Store in a refrigerator (2°C - 8°C). Do not freeze.
Store in the original outer packaging to protect from light.
Do not use this vaccine after the expiry date stated on the packaging after EXP.
The expiry date (EXP) means the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What VERORAB Vaccine Contains

• After reconstitution, 1 vial contains: Inactivated rabies virus, Wistar Rabies PM/WI38 1503-3M strain, 3.25 IU, grown on VERO cells, quantified by ELISA according to international standards.
• Other ingredients are: Powder: maltose, 20% human albumin solution, Basal Medium Eagle (a mixture of mineral salts, including potassium, vitamins, dextrose, and amino acids, including phenylalanine), water for injection, hydrochloric acid, sodium hydroxide. Solvent: sodium chloride, water for injection.

What VERORAB Vaccine Looks Like and Contents of the Pack

1 vial of powder + 1 pre-filled syringe with needle and solvent for 0.5 ml - in a cardboard box.
10 vials of powder + 10 pre-filled syringes with needle and solvent for 0.5 ml - in a cardboard box.
5 vials of powder + 5 ampoules of solvent for 0.5 ml - in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly, France

Manufacturer

Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile, France
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil, France
Sanofi-Aventis Zrt.
Bdg. DC5 - Campona Utca 1.
Budapest XXII - 1225 Budapest - Hungary
Date of Last Revision of the Leaflet:December 2024

Information Intended for Healthcare Professionals Only:

Vaccination schedule recommendations should be strictly followed.
Pre-filled Syringe
Instructions for use:

• Remove the cap from the vial of lyophilized powder.
• Screw the plunger into the syringe if it is provided separately.
• Inject the solvent into the vial of lyophilized powder.
• Gently rotate the vial until a homogeneous suspension is obtained.
• The reconstituted vaccine should be clear, homogeneous, and free of particles.
• Discard the syringe used for reconstitution.
• Use a new syringe with a new needle to draw up the prepared vaccine.
• The needle used to draw up the prepared vaccine should be replaced with a new needle for intramuscular or intradermal injection. The length of the needle used for vaccine administration should be adapted to the patient.

Ampoule
Instructions for use:

• Remove the cap from the vial of lyophilized powder.
• Break the top of the ampoule. Draw up the solvent using a syringe.
• Inject the solvent into the vial of lyophilized powder.
• Gently rotate the vial until a homogeneous suspension is obtained.
• The reconstituted vaccine should be clear, homogeneous, and free of particles.
• Draw up the suspension using a syringe.
• The needle used to draw up the prepared vaccine should be replaced with a new needle for intramuscular or intradermal injection. The length of the needle used for vaccine administration should be adapted to the patient.

If VERORAB vaccine is administered intramuscularly, it must be used immediately after reconstitution.
If VERORAB vaccine is administered intradermally, the vaccine can be used within 6 hours of reconstitution, provided it is stored at a temperature not exceeding 25°C, protected from light. After reconstitution in 0.5 ml of solvent, 0.1 ml doses of vaccine should be drawn up from the vial under aseptic conditions. The remainder may be used for another patient. Before each draw-up, gently rotate the vial until a homogeneous suspension is obtained. A new needle and syringe should be used to draw up and administer each dose of vaccine to each patient to avoid cross-contamination. Unused vaccine should be discarded after 6 hours.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
This medicinal product is subject to medical prescription.