VERORAB 3.25 IU Proszek i rozpuszczalnik do zawiesiny do wstrzykiwań

Treść ulotki

1. What is Verorab and what is it used for
2. What you need to know before you use Verorab
3. Verorab contains 4.1 micrograms of phenylalanine in each 0.5 mL dose, equivalent to
   1. How to use Verorab
   2. Possible side effects
   3. How to store Verorab
   4. Package contents and other information

Verorab, powder and solvent for suspension for injection
Inactivated rabies vaccine
Read this leaflet carefully before you or your child receive the vaccination because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you or your child only. Do not pass it on to others.
• If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Verorab is and what it is used for
• 2. What you need to know before you use Verorab
• 3. How to use Verorab
• 4. Possible side effects
• 5. How to store Verorab
• 6. Contents of the pack and other information

1. What is Verorab and what is it used for

Verorab is a rabies vaccine indicated for pre- and post-exposure rabies prophylaxis in all age groups.
Verorab must be used in accordance with official recommendations.

2. What you need to know before you use Verorab

Do not use Verorab
Pre-exposure prophylaxis:

• if you or your child are allergic to the active substance or to any of the other ingredients of this medicine, listed in section 6.
• if you or your child have developed an allergic reaction during a previous injection of this medicine or of any vaccine with the same composition.
• if you or your child have a fever or if you have an acute illness (in this case, it is preferable to postpone vaccination).

Post-exposure prophylaxis:

• Given the fatal outcome of declared rabies infection, there are no contraindications to post-exposure vaccination.

Warnings and precautions

• As with all vaccines, Verorab may not protect 100% of vaccinated people.
• Verorab must not be administered intravascularly; ensure that the needle does not penetrate a blood vessel.
• Use with caution if you or your child are allergic to polymyxin B, streptomycin or neomycin (present in trace amounts in the vaccine) or to any antibiotic of the same class.
• As with any other injectable vaccine, appropriate medical treatment and monitoring must be readily available in the event of a rare anaphylactic reaction after vaccine administration.
• The need to perform serological tests (to evaluate seroconversion in individuals) must be determined in accordance with official recommendations.
• When the vaccine is administered to individuals with known impaired immunity (immunodeficiency), due to an immunosuppressive disease or concomitant immunosuppressive treatment, blood tests should be performed 2 to 4 weeks after vaccination to ensure that a protective immune response has been obtained. In the case of post-exposure vaccination, a complete vaccination schedule must be administered. In the case of any Category II or III exposure, rabies immunoglobulin should also be administered in association with the vaccine; see “ 3. Howto use Verorab”.
• Verorab must be administered with caution to individuals with a reduced platelet count (thrombocytopenia) or coagulation disorders, due to the risk of bleeding that may occur during intramuscular administration.
• Tell your doctor, pharmacist or nurse before using Verorab if you or your child have had an allergic reaction to latex. The cap of the pre-filled syringe without the needle inserted contains a natural rubber latex derivative that may cause a serious allergic reaction.

Consult your doctor, pharmacist or nurse before using Verorab.

Children and adolescents
Not applicable.

Other medicines and Verorab
Immunosuppressive treatments, including long-term systemic therapy with corticosteroids,
may interfere with antibody production and lead to vaccination failure. It is therefore recommended
to undergo serological testing 2 to 4 weeks after vaccination; see
“ Warnings and precautions”.
Verorab can be administered in association with a Vi polysaccharide-based typhoid vaccine
during the same vaccination session using two different injection sites.
Rabies immunoglobulin or any other product and the rabies vaccine should never
be combined in the same syringe or injected into the same site.
Because rabies immunoglobulin interferes with the development of the immune response to
rabies vaccine, the recommendations for
the administration of rabies immunoglobulin must be strictly followed.
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might
take any other medicines.

Verorab with food and drink
Not applicable.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Data on the use of Verorab in pregnant women are limited.
It is not known whether Verorab is excreted in breast milk, but no risk has been identified and is not expected for
newborns receiving breast milk.
Given the severity of the disease, Verorab may be administered during pregnancy or breastfeeding
after a risk-benefit assessment by the doctor.

Driving and using machines
Dizziness after vaccination has been frequently reported. This may temporarily affect
your ability to drive vehicles or use machines.

Verorab contains phenylalanine, potassium and sodium

Verorab contains 4.1 micrograms of phenylalanine in each 0.5 mL dose, equivalent to

0.068 micrograms/kg for a person of 60 kg. Phenylalanine may be harmful to you if you suffer from
phenylketonuria (PKU), a rare genetic disease that causes the accumulation of phenylalanine because the body
cannot eliminate it correctly.
Verorab contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium (23 mg) per dose,
meaning essentially “potassium-free” and “sodium-free”.

3. How to use Verorab

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 0.5 mL of reconstituted vaccine to be administered intramuscularly (IM) or
0.1 mL of reconstituted vaccine to be administered intradermally (ID) at each injection site.

• Pre-exposure prophylaxis

For primary pre-exposure immunization, immunocompetent individuals may be
vaccinated according to one of the vaccination schedules presented in Table 1 and according to
official local recommendations, if available:

Table 1: Pre-exposure vaccination schedules
G0G7G21 or G28
Intramuscular use (0.5 mL per dose)
Three-dose regimen
IM use – 0.5 mL
1 dose 1 dose 1 dose
One-week regimen
IM use – 0.5 mL
1 dose 1 dose

Intradermal use (0.1 mL per dose)
One-week regimen
ID use – 0.1 mL
2 doses 2 doses
Booster doses are determined based on the risk of exposure and serological tests to detect the
presence of neutralizing antibodies to the rabies virus (≥ 0.5 IU/mL). A booster dose consists of
a 0.5 mL dose administered intramuscularly or a 0.1 mL dose administered
intradermally according to WHO recommendations.

• Post-exposure prophylaxisPost-exposure prophylaxis should be started as soon as possible after suspected exposure to rabies. In all cases, proper wound care (thorough washing of all bites and scratches with soap or detergent and copious amounts of water and/or virucidal agents) should be performed immediately or as soon as

possible after exposure. This should be done before administration of the rabies vaccine or rabies immunoglobulin, when indicated.

Table 2: WHO guidance for post-exposure prophylaxis depending on the level of exposure
(adapt according to local official recommendations).

Post-exposure prophylaxis in non-immunized individuals
Non-immunized individuals may be vaccinated using one of the intramuscular (IM) or intradermal (ID) vaccination regimens presented in Table 3.

Table 3: Post-exposure prophylaxis ofnon-immunized individuals
G0 G3 G7 G14 G21 G28

Intramuscular use (0.5 mL per dose)
Essen IM protocol
IM use – 0.5 mL/dose
1 dose 1 dose 1 dose 1 dose - 1 dose
Zagreb IM protocol
IM use – 0.5 mL/dose
2 doses - 1 dose - 1 dose -

Intradermal use (0.1 mL per dose)
New ID regimen of the Thai Red Cross
Thailand Red Cross,TRC
ID use – 0.1 mL/dose
2 doses 2 doses 2 doses - - 2 doses
ID regimen of the Pasteur Institute of Cambodia (IPC) 2 doses 2 doses 2 doses - - -
ID use – 0.1 mL/dose
4-site 1-week ID regimen
ID use – 0.1 mL/dose
4 doses 4 doses 4 doses - - -
Regardless of the regimen used, vaccination should not be interrupted unless the animal is declared non-rabid.
Rabies immunoglobulin should be administered in the event of any category III exposure (WHO classification, see Table 2). If possible, each dose of vaccine should be
administered at a body site distant from the sites of immunoglobulin administration.
Post-exposure prophylaxis in already immunized individuals
In accordance with official recommendations, this applies to individuals who have already received
pre-exposure prophylaxis or post-exposure prophylaxis or who have discontinued post-exposure
prophylaxis after receiving at least two doses of cell culture-prepared vaccine.
Individuals who have already been immunized should receive 1 dose of vaccine (0.5 mL intramuscularly or 0.1 mL intradermally) at G0 and 1 dose at G3. Alternatively, 4 intradermal injections of 0.1 mL may be administered at 4 separate sites at G0. Rabies immunoglobulin is not indicated in this case.

Individuals with reduced immunity
Pre-exposure prophylaxis
A 3-dose regimen (listed in the "Pre-exposure prophylaxis" subsection) should be used and
serological testing for neutralizing antibodies should be performed 2 to 4 weeks after the last dose
to assess the possible need for an additional dose of vaccine.
Post-exposure prophylaxis
A complete vaccination regimen should be administered after exposure. Rabies immunoglobulin should be administered in association with the vaccine in the event of any category II and III exposure (see Table 2).

Use in children
A child should receive the same dose as an adult.

Route of administration

• Intramuscular (IM) use

The vaccine is administered in the anterolateral region of the thigh muscle in infants
and young children and in the deltoid muscle in older children and adults.
If the Zagreb regimen is used, a dose should be administered in each deltoid muscle (left and right) in adults at G0, then one dose at G7 and G21.

• Intradermal (ID) use The vaccine is administered preferably in the upper arm or forearm.

Verorab should not be injected into the buttock region.
The vaccine should not be injected intravascularly.

If you or your child uses more Verorab than you should
Not applicable.

If you or your child forgets to use Verorab
Not applicable.

If you or your child stops using Verorab
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

Serious allergic reactions:
Serious allergic reactions (anaphylactic reactions) can always occur, although they are very rare.
Contact your doctor or healthcare professional immediately or go immediately to the nearest hospital emergency
room if you or your child experience an anaphylactic reaction.
The signs or symptoms of an anaphylactic reaction usually occur very soon after the injection,
if present, and may include skin rash, itching, difficulty breathing, wheezing and
swelling of the face, lips, throat or tongue.

Other side effects
Most side effects occur within 3 days of vaccination. The effects usually
resolve spontaneously within 1–3 days of onset. They have been reported with the
following frequencies:
Very common: may affect more than 1 in 10 people

• General feeling of discomfort,
• Headache (cephalalgia),
• Muscle pain (myalgia),
• Pain at the injection site,
• Redness (erythema) at the injection site,
• Swelling at the injection site,
• In children only: irritability, inconsolable crying and drowsiness.

Common: may affect up to 1 in 10 people

• Fever,
• Enlarged lymph nodes (lymphadenopathy),
• Allergic reactions, such as skin rash and itching,
• Flu-like syndrome,
• Tingling (pruritus) at the injection site,
• Hardening at the injection site,
• In children only: difficulty sleeping.

Uncommon: may affect up to 1 in 100 people

• Loss of appetite,
• Nausea,
• Stomach pain (abdominal pain),
• Diarrhea,
• Vomiting,
• Chills,
• Fatigue, unusual weakness (asthenia),
• Dizziness,
• Joint pain (arthralgia),
• Bruising at the injection site (ecchymosis),

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

• Difficulty breathing.

Not known: frequency cannot be estimated based on available data

• Swelling of the face, lips, mouth, tongue or throat, which can cause difficulty swallowing or breathing,
• Sudden loss/reduction of hearing.

Reporting of side effects
If you or your child gets any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Verorab

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date
refers to the last day of that month.
Store in a refrigerator (2°C–8°C). Do not freeze.
Store in the original outer packaging, protected from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Verorab contains

• The active ingredient is: After reconstitution with 0.5 mL of solvent, 1 vial contains: Rabies virus, WISTAR Rabies PM/WI38 1503-3M strain (inactivated) ........................... 3.25 IU Produced on Vero cells Quantity measured based on the ELISA test compared to the international standard
• Other ingredients are: Powder:maltose, 20% human albumin solution, BME culture medium (Basal Medium Eagle) (a mixture of mineral salts including potassium, vitamins, dextrose and amino acids, including L-phenylalanine), water for injections, hydrochloric acid and sodium hydroxide.

Solvent:sodium chloride, water for injections.
May contain traces of polymyxin B, streptomycin and neomycin, used in the manufacturing process;
see “Warnings and precautions”.

Description of the appearance of Verorab and package contents
Verorab is a powder and solvent for suspension for injection (powder in a vial + 0.5 mL of
solvent in a pre-filled syringe with or without a needle – Box of 1 or 10).

Marketing authorization holder and manufacturer
Marketing authorization holder:
Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Representative for Italy
Sanofi S.r.l. - Viale L. Bodio, 37/B – 20158 Milan
Manufacturer:
Sanofi Pasteur - 1541 avenue Marcel Mérieux - 69280 Marcy-l’Étoile – France
Sanofi Pasteur - Parc Industriel d’Incarville - 27100 Val-de-Reuil - France
Sanofi-Aventis Zrt. Bldg. DC5 - Campona Utca 1. Budapest XXII - 1225 Budapest - Hungary

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following names:

• Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom (Northern Ireland): Verorab.
• France: Vaccin Rabique Pasteur

Other sources of information
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The following information is intended exclusively for healthcare professionals:
The recommendations on the vaccination schedule must be followed scrupulously.
Instructions for handling:

• Remove the cap from the lyophilized powder vial.
• Screw the plunger rod into the syringe, if supplied separately.
• For the needleless syringe: attach the reconstitution needle to the syringe
• Inject 0.5 mL of solvent into the lyophilized powder vial.
• Gently shake the vial until a homogeneous suspension of the powder is obtained.
• The reconstituted vaccine must be clear, homogeneous and free of particles. o For the syringe with pre-attached needle
• Remove and dispose of the syringe used for reconstituting the vaccine.
• Use a new syringe with a new needle to draw up the reconstituted vaccine. o For the needleless syringe
• Draw up the suspension using a syringe.
• Replace the needle used to draw up the vaccine with a new needle for intramuscular or intradermal injection.
• The length of the needle used for vaccine administration must be adapted to the patient.

If Verorab is administered intramuscularly, the vaccine must be used
immediately after reconstitution.
If Verorab is administered intradermally, the vaccine can be used up to 6 hours after
reconstitution, provided it is stored at a temperature below 25°C and protected from light.
After reconstitution with 0.5 mL of solvent, using aseptic techniques, a
dose of 0.1 mL must be drawn up from the vial. The remainder can be used for another patient. Before each draw up,
gently shake the vial to obtain a homogeneous suspension. To draw up and
administer each dose of vaccine to each patient, a new sterile needle
and a new sterile syringe must be used to prevent cross-infection. Unused reconstituted vaccine must
be discarded after 6 hours.
The unused medicinal product and waste derived from such medicinal product must be disposed of in accordance
with local regulations.
This medicinal product is subject to medical prescription.