What it is and what it is used for

for 4.

Guide

WHO for post-exposure prophylaxis depending on level of exposure (adapt according to local official recommendations). Type of exposure to

What you need to know before you take it

e Verorab Do not use Verorab Pre-exposure prophylaxis: Ifyou or your child are allergic to the active substance or any of the other ingredients of this medicine, listed in section 6. you your child developed an allergic during a previous injection of this or of any vaccine the composition. or your child are feverish or if you have an acute disease (in this case, it is preferable to postpone vaccination). –

or

–

–

with

medicine

same

reaction

Post-exposure prophylaxis:

fatal outcome of the declared rabies infection, to post-exposure vaccination. Warnings and precautions all vaccines, Verorab may not protect 100% of people vaccinated. Verorab must not be administered via the intravascular route; make sure the needle does not penetrate a blood vessel. Use with caution if you or your child are allergic to polymyxin B, to streptomycin or neomycin (present in trace amounts in the vaccine) or any antibiotic of the

to

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|

DO D7 D3 Intradermal use (0.1 mL per dose) New Thailand Red Cross (TRC) ID regimen 2 doses ID use 0.1 mL/dose Institute Pasteur of Cambodia doses|2 doses) (IPC) ID regimen 2 ID use 0.1 mL/dose 1-week ID regimen ID use 0.1 mL/dose

D28

2

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–

–

one IM injection in the anterolateral region of each thigh (in infants and young children) or in each deltoid (in older children and adults). to be injected in 2 separate sites, contralateral if possible. to be injected in 4 separate sites.

Irrespective of the regimen used, vaccination should not be discontinued unless the

pharmacist

you think

before women limited. Data unknown whether Verorab excreted human anticipated infants

are

breast

Verorab must not be injected in the buttock region. The vaccine must not be injected via the intravascular route. If you or your child use more Verorab than you should applicable. Notapplicable. If you or your child forget to use Verorab Not applicable. If you or your child stop using Verorab Not applicable. If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

How to take it

Verorab Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor sure doctor or pharmacist if you are not sure. The recommended dose isis 0.5 mL of reconstituted vaccine vaccine intramuscularly (IM) or 0.1 mL of reconstituted vaccine intradermally (ID) in each injection site. prophylaxis prophylaxis For primary pre-exposure immunisation, individuals can be vaccinated according accordingto one of the vaccination schedules presented in Table 1 and according to local official recommendations when available: Pre-exposure vaccination schedules Table 1: Pre-exposure D7 DO D21 or D28 Intramuscular route (0.5 mL per dose)

therefore recommended to Verorab is a rabies vaccine indicated for pre-exposure and post-exposure rabies Verorab prophylaxis in all age groups. administered association with Vi Verorab should be used in accordance with official recommendations. the vaccination different

Possible side effects

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

them.

them.

already received pre-exposure prophylaxis or post-exposure prophylaxis or who discontinued post-exposure prophylaxis after receiving at least two doses of vaccine prepared in cell culture. Individuals who have already been immunised must receive 1 dose of vaccine (0.5 mL intramuscularly or 0.1 mL intradermally) on DO and 1 dose on D3. Alternatively, injections of 0.1 mL may be administered in 4 separate sites on DO. Rabies immunoglobulins are not indicated in this case. Individuals with decreased immunity Pre-exposure prophylaxis regimen should be used (listed in subsection "Pre-exposure a serological test for neutralising antibodies should be performed 2 to 4 weeks after last dose to assess the possible need for an additional dose of vaccine. Post-exposure prophylaxis A complete vaccination regimen should be administered post-exposure. immunoglobulins should be administered in association with the vaccine in the event any category and III exposure (see Table 2). Use in children A child must receive the same dose as an adult. Method of administration

II

or

Other side effects Most side effects occur within 3 days of vaccination. The effects most often resolve spontaneously within 1 to 3 days of onset. They have been reported with the –

use (ID)

or

The vaccine is administered preferably in the upper arm the forearm.

common: may affect more than 1 in 10 people Generally feeling unwell, Headache (cephalalgia), Painat

pain (myalgia),

Redness (erythema) at the at the injection site, Swelling in babies: irritability, inconsolable crying and drowsiness. up to 10 people Common: may affect Fev er, Fever Increase in size of lymph nodes (lymphadenopathy),

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–

Allergic reactions, such as rash and itching, syndrome, Itching (pruritus) at the injection site, at the injection site, Only in babies: difficulty sleeping. may affect up to 100 people Decreased appetite, Nausea,

Stomach pain (abdominal pain), Diarrhoea, Vomiting,

confirmed

For primary pre-exposure immunisation, individuals can bevaccinated

regimen IM route 0.5 mL regimen One-week regimen IM route 0.5 mL –

–

1 dose

1 dose

1 dose

1 dose

–

2 doses

testing

animals or

or

animals Licks on intact skin (no exposure) Nibbling of uncovered skin skin Minor scratches or abrasions without bleeding (exposure)

to

immunity") One One injection in each arm (for adults and children) or each anterolateral thigh (infants and toddlers) Booster doses are determined based on the risk of exposure and on serological tests to IU/ml). A detect the rabies virus-neutralising lisi antibodies (> 0.5 IU/ml). Abbooster d booster dose of f rabies h the presence of virus-neutralising consists of one dose of 0.5 mL given by by intramuscular route or one dose of 0.1 mL in accordance with WHO recommendations. by intradermal route in Post-exposure prophylaxis Post-exposure prophylaxis should be initiated as soon as possible after suspected rabies, exposure to rabies. In all cases, proper proper wound care (careful soap washing of all bites and scratches with soap (careful washing 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 rabies vaccine or rabies immunoglobulin, where they are indicated.

A

vi

or

prophylaxis

–

–

( If the animal is an apparently healthy dog or cat living in a low-risk area and placed under veterinary observation, (a) treatment may be delayed. (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 for the presence of rabies virus using appropriate laboratory methods. Bites, particularly WO ( as Category exposure to the extensive to the head, neck, face, hands and genitals are classified ds innervation ofthese these parts of of the body.

unusual weakness (asthenia), Dizziness,

due

of

Post-exposure prophylaxis in non-immunised individuals individuals may be vaccinated according to one of the vaccination regimens by intramuscular use (IM) or by intradermal use (ID) presented in table 3. prophylaxis of non-immunised individuals Post-exposure Table 3: D28

Essen protocol

scratches

Chills,

| 1dose | 1dose |1 dose

use 0.5 mL/dose Zagreb protocol 0.5

–

NotSwelling known: cannot be estimated from the available data of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing, Sudden hearing loss/decrease. Reporting of side effects If you or your child get any side effects, talk to your doctor, pharmacist or nurse. includes any possible side effects not listed in this leaflet. You can also report side directly via the Medicines and Healthcare products Regulatory Agency (MHRA), Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Play or or Apple App Store. By reporting reporting side effects you can help provide more information on the safety of this medicine. m –

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DC5

XXII

1.

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following information is intended for healthcare professionals only: recommendations should be followed scrupulously. Handling instructions: the vial vial of lyophilised powder. Remove the cap ofthe Screw the plunger rod into the syringe, if provided separately. the needle to the syringe syringe vial oFof lyophilised powder. Inject the solvent into vial Shake the vial gently until homogeneous suspension of the powder is obtained. The reconstituted vaccine should be limpid, homogeneous and free from particles. o For syringe with attached needle Remove and discard the syringe that was used for vaccine reconstitution. = Use a new syringe with a new needle to withdraw the reconstituted vaccine. o For syringe without needle = Withdraw the suspension using a syringe. the needle used to withdraw the vaccine with a new needle for intramuscular or intradermal injection. of the needle used for vaccine administration should be adapted to the

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of

of

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Ke this medicine out of the sight and reach of children. Keep on the Do not use thic this madirine medicine after after the the ayniry date which which icis ctatad stated nn the hhy box after after EYP EXP. Tha The D not expiry date expiry date refers to the last day of that month. expiry Store in a refrigerator (2°C 8°C). Do not freeze. St in the original outer package, protected from light. Store Do not throw away any medicines via wastewater or household waste. Ask your how to throw away medicines you no longer use. These measures will help pl pharmacist protect the environment.

dose

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France Distributed by: Distributed Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Tel: 0800 035 2525 Manufacturer: Sanofi Winthrop Industrie 1541 avenue Marcel Mérieux 69280 Marcy France Sanofi Winthrop Industrie Voie de Parc Industriel B.P 101 27100 Val de Reuil France Budapest udapest Hungary Hunga Campona Utca Utca Sanofi-Aventis anofi-Aventis Zrt. Bdg. 1225 Budapest Campona Budapest This leaflet was last revised in October 2025. –

–

1 dose

1 dose

2

–

pain (arthralgia), at the injection site (ecchymosis). Rare: may affect up to 1 in 1000 people Difficulty breathing.

–

refers

isi

after

a-This regimen should not be used for individuals with decreased immunity (see subsection "Individuals with decreased

bites

the

the

2 doses

of accordance Post-exposure prophylaxis

None if reliable case history is available.

Administer rabies vaccine immediately. animal is in Di Discontinue treatment if thethe animal animal in good health after the 10-day observation or if the rabies test performed using appropriate laboratory methods is negative. Treat as category if bat exposure involved. Administer rabies vaccine immediately and rabies immunoglobulins, preferably Single or multiple as soon as possible after initiation of posttransdermal exposure prophylaxis. or scratches, licks on Rabies immunoglobulins can be injected broken skin or up to 7 days after the first dose of vaccine is contamination of administered. mucous membrane with Discontinue treatment if the animal is in saliva (licks), exposure to the 10-day observation good health (severe exposure) bats or if the rabies test performed using appropriate laboratory methods is negative.

1 dose

consists

Post-exposure prophylaxis recommended

Touching feeding feeding of

Intradermal route (0.1 mL per dose)

One-week regimen ID route 0.1 mL

be rabi

or not available for

Foror

without Attach without needle: the the solvent the i

reconstitution

i

ituti

of

–

injection site,

use (IM) 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, one dose should be administered in each deltoid muscle (left and right) in adults at DO, then one dose at D7 and D21.

tonque

|

mL

animal animal is declared free from rabies. reactions: Serious allergic can always happen, allergic reactions (anaphylactic reactions) can happen, even if it 'Sis Rabies immunoglobulins be in the event of any category very rare. Contact Contact your doctor or health health care professional immediately or go to the should administered exposure (WHO classification, see Table 2). If possible, each dose of the vaccine should hospital emergency department immediately if you or your child experience an department immediately effects be administered at a body site distant from the immunoglobulin administration sites. anaphylactic reaction. of an anaphylactic reaction usually occur very soon after the injection medicine. Signs or symptoms of Post-exposure prophylaxis in already immunised individuals rash, itching, difficulty breathing, shortness of breath and 5, Howto store if at all, all, and may include store Verorab In accordance with official recommendations, this applies to individuals who include face, lips, gue. of the face, throat or tongue. lips, throat

reactions

a domestic or wild animal, | to

Exposure

How to store it

Verorab 6. Contents of of the pack and and other information

you to

Other medicines and Verorab Immunosuppressive treatments, including long-term systemic corticosteroid therapy, may interfere with the production of antibodies and lead to vaccination failure. It get a serological test 2 to 4 weeks after vaccination; see and preca can be a polysaccharide typhoid vaccine in visit using two during same injection Rabies immunoglobulins or any other product and the rabies vaccine must never be combined in the same syringe or injected into the same site. 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. Tell your doctor or pharmacist if you or your child are taking, has recently taken or might take any other medicines. with food and drink Not ot app! applicable Pregnancy and breast-feeding may be pregnant or pregnant or breast-feeding, ask your doctor or pharmacist for aavice advice a Daby, baby, aSk using this medicine. Data on the use of Verorab in pregnant women are in pregnant milk, but no risk has been identified is It in anticipated for or infants receiving and is anticipated milk. receiving breast milk. Given the seriousness seriousness of the disease, Verorab can be given during pregnancy or breastfeeding following an assessment of the risks and benefits by your physician. Driving and using machines

dizziness was frequently reported. This can temporarily affect the ability drive or use machines. contains phenylalanine, potassium and sodium dose, which is equivalent Verorab contains 4.1 micrograms phenylalanine in each 0.5 to 0,068 microgram/kg for a 60 kg person. Phenylalanine may be harmful if you have (PKU), a rare genetic disorder in which phenylalanine builds up because body cannot remove it properly. contains less than 1 mmol of potassium (39 mg) and less than 1 mmol of sodium mg) per dose, that is to say essentially 'potassium-free' and

Contents of the pack and other information

What Verorab contains W The active substance is: After reconstitution with 0.5 mL solvent, 1 vial contains: WISTAR Rabies PM/WI38 1503-3M strain (inactivated) Rabies –

produced Produced in Vero cells

Quantity measured according to the ELISA test against the international standard

The other ingredients are: Powder: maltose, 20% human albumin solution, Basal Medium Eagle (mixture of m mineral salts including potassium, vitamins, dextrose and amino acids including L-phenylalanine), water for injections, hydrochloric acid and sodium hydroxide. Solvent: sodium chloride, for injections. M contain traces of polymyxin B, streptomycin and neomycin, used in the May mmanufacturing process; see "Warnings and precautions". W What Verorab looks like and contents of the pack Verorab Ve is a powder and solvent for suspension for injection (powder in vial + 0.5 mL of solvent in prefilled syringe with or without needle Box of or 10). –

water

a

1

If Verorab is administered intramuscularly, the vaccine must be used immediately after reconstitution.

If Verorab is administered intradermally, the vaccine may be used up to 6 hours after on the condition that is stored at a temperature below 25°C and protected from light. After reconstitution with the solvent, using aseptic techniques, each dose of 0.1 mL must be taken from the vial. The rest may be used for another individual. Before each withdrawal, shake vial gently to obtain a homogenous suspension. A new sterile needle and a newsterile syringe must be used to withdraw and administer each vaccine to each individual to avoid cross-infection. The unused reconstituted vaccine must be thrown away after 6 hours. Any unused medicinal product or waste material should be disposed of in accordance local requirements. This medicinal product is subject to medical prescription.

the

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