Verorab

The active substance is: After reconstitution with 0.5 mL solvent, 1 vial contains: Rabies virus^a, WISTAR Rabies PM/Wi38 1503-3M strain (inactivated) 3.25 IU^b.
^a Produced in VERO cells.
^b Quantity measured according to the ELISA test against the international standard.
Excipients/Inactive Ingredients: The other ingredients are: Powder: maltose, 20% human albumin solution, Basal medium Eagle (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 Precautions.

Pharmacotherapeutic group: rabies vaccines. ATC code: J07BG01.

VERORAB is indicated for pre-exposure and post-exposure rabies prophylaxis in all age groups.
Verorab should be used in accordance with 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 with 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.

Always use this medicine exactly as told by the doctor or pharmacist. Check with the doctor or pharmacist if not sure.
Intramuscular use (IM): the recommended dose is 0.5 mL of reconstituted vaccine.
Intradermal use (ID): the recommended dose is 0.1 mL of reconstituted vaccine per injection site.
Pre-exposure prophylaxis: For pre-exposure immunisation, immunocompetent individuals can be vaccinated according to one of the vaccination schedules presented in Table 1 and according to official recommendations. (See Table 1.)

Click on icon to see table/diagram/image

Booster doses are determined based on the risk of exposure and on serological tests in accordance with official recommendations.
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 rabies vaccine or rabies immunoglobulin, where they are indicated. Post-exposure prophylaxis should be adjusted to the exposure category, the condition of the animal (see Table 3) and the vaccination status of the patient, in accordance with official recommendations (see Table 3, WHO recommendations).
If necessary, post-exposure prophylaxis can be supplemented by tetanus prophylaxis and antibiotic therapy to prevent the development of infections other than rabies.
Post-exposure prophylaxis should be performed as soon as possible after exposure under medical supervision and only at a rabies centre. (See Tables 2 and 3.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Post-exposure prophylaxis in non-immunised subjects: Non-immunised subjects may be vaccinated according to one of the vaccination regimens by intramuscular use (IM) or by intradermal use (ID) presented in Table 4. (See Table 4.)
In all cases, refer to the local official recommendations.

Click on icon to see table/diagram/image

Whatever the regimen used, vaccination must not be discontinued unless the contact animal is declared free from rabies after veterinary supervision (see Table 3).
Rabies immunoglobulins should be administered in the event of any category III exposure (WHO classification, see Table 2). If possible, the vaccine should be administered contralaterally to the immunoglobulin administration sites.
Refer to the package leaflet of the rabies immunoglobulins used.
Post-exposure prophylaxis in already immunised subjects: In accordance with official recommendations, this applies to subjects who have 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.
Subjects who have already been immunised must receive 1 dose of vaccine (0.5 mL intramuscularly or 0.1 mL intradermally) on D0 and 1 dose on D3.
Alternatively, 4 intradermal injections of 0.1 mL may be administered in 4 separate sites on D0.
Rabies immunoglobulins are not indicated in this case.
Individuals with decreased immunity: Pre-exposure prophylaxis: In individuals with decreased immunity, conventional three-dose regimens should be used (see Table 1) and a serological test for neutralising antibodies should be performed 2 to 4 weeks after the last dose of the vaccine to assess the need for a possible additional dose of vaccine.
Post-exposure prophylaxis: In individuals with decreased immunity, a complete vaccination regimen should be administered (see Table 4). Rabies immunoglobulins should be administered in association with the vaccine in the event of any category II and III exposure (see Table 1).
Use in children: A child must receive the same dose as an adult (0.5 mL intramuscularly or 0.1 mL intradermally).
Method of administration: Intramuscular use (IM): The vaccine is administered in the anterolateral region of the thigh muscle in infant 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 D0, then one dose at D7 and D21.
Intradermal use (ID): The vaccine should ideally be administered in the upper arm or the forearm.
The vaccine must not be injected in the buttocks region.
The vaccine must not be injected via the intravascular route.
If there are any further questions on the use of this medicine, ask the doctor or pharmacist or nurse.

Pre-exposure vaccination: If the patient is allergic to the active substance or any of the other ingredients of this medicine, listed in Description.
If the patient developed an allergic reaction during a previous injection of this medicine or of any vaccine with the same composition.
If the patient is feverish or if has an acute disease (in this case, it is preferable to postpone vaccination).
Post-exposure vaccination: Given the fatal outcome of the declared rabies infection, there are no contraindications to post-exposure vaccination.

As with 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 the patient is allergic to polymyxin B, to streptomycin or to neomycin (present in trace amounts in the vaccine) or to any antibiotic of the same class.
As with all injectable vaccines, appropriate medical treatment and supervision must be readily available in case of a rare anaphylactic reaction after vaccine administration.
The need for serological tests (to assess seroconversion in the subjects) should be determined in accordance with official recommendations.
When the vaccine is administered to subjects with a known reduction in immunity (immunodeficiency), due to an immunosuppressive disease or a concomitant immunosuppressive treatment, blood tests must be performed 2 to 4 weeks after vaccination to ensure that a protective immunising response was obtained. In case of post-exposure vaccination, a complete vaccination regimen must be administered. Rabies immunoglobulins should also be administered in association with the vaccine in the event of any category II or III exposure, see Dosage & Administration.
VERORAB should be administered with caution to subjects with a decreased platelet level (thrombocytopenia) or clotting disorders, because of the risk of bleeding that may occur during intramuscular administration.
Talk to the doctor, pharmacist or nurse before using VERORAB.
Verorab, powder and solvent for suspension for injection in prefilled syringe contains phenylalanine, potassium and sodium: Verorab contains 4.1 micrograms phenylalanine in each 0.5 mL dose, which is equivalent to 0.068 microgram/kg for a 60 kg person. Phenylalanine may be harmful if you have 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'.
Driving and using machines: Post-vaccination dizziness was frequently reported. This can temporarily affect the ability to drive or use machines.

Pregnancy: One animal toxicity study on reproduction and development, led with another inactivated rabies vaccine produced in VERO cells, did not evidence any deleterious effects on female fertility and on pre and post-natal 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 foetotoxic effects to date.
Pre-exposure prophylaxis: Given the seriousness of the disease, in case of high risk 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.
Breast-feeding: This vaccine can be used during breast-feeding.
Fertility: Verorab has not been evaluated in fertility studies.
If pregnant or breast-feeding, thinking may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before using this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious allergic reactions: Serious allergic reactions (anaphylactic reactions) can always happen, even if it is very rare. Contact the doctor or health care professional immediately or go to the nearest hospital emergency department immediately if the patient experiences an anaphylactic reaction.
Signs or symptoms of an anaphylactic reaction usually occur very soon after the injection if at all, and may include rash, itching, difficulty breathing, shortness of breath and swelling of the face, lips, throat or tongue.
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 following frequencies: Very common: may affect more than 1 in 10 people: Generally feeling unwell; Headache (cephalalgia); Muscle pain (myalgia); Pain at the injection site; Redness (erythema) at the injection site; Swelling at the injection site; Only in babies: irritability, inconsolable crying and drowsiness.
Common: may affect up to 1 in 10 people: Fever; Increase in size of lymph nodes (lymphadenopathy); Allergic reactions, such as rash and itching; Flu-like syndrome; Itching (pruritus) at the injection site; Induration at the injection site; Only in babies: difficulty sleeping.
Uncommon: may affect up to 1 in 100 people: Decreased appetite; Nausea; Stomach pain (abdominal pain); Diarrhoea; Vomiting; Chills; Fatigue, unusual weakness (asthenia); Dizziness; Joint pain (arthralgia); Bruising at the injection site (ecchymosis).
Rare: may affect up to 1 in 1000 people: Difficulty breathing.
Not known: cannot be estimated from the available data: Swelling of the face, lips, mouth, tongue or throat, which may cause difficulty swallowing or breathing; Sudden hearing loss/decrease.
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph.
By reporting side effects, it can help provide more information on the safety of this medicine.

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 get a serological test 2 to 4 weeks after vaccination; see Precautions.
Verorab can be administered in association 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.
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 the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.

Injection-schedule recommendations should be followed scrupulously.
Handling instructions: Remove the cap off 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 homogenous suspension of the powder is obtained.
The reconstituted vaccines 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 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 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 reconstitution on the condition that is stored at a temperature below 25°C and protected from light.
After reconstitution with 0.5 mL of solvent, using aseptic techniques, a 0.1 mL vaccine dose must be taken from the vial. The rest may be used for another patient. Before each withdrawal, shake the vial gently to obtain a homogenous suspension. A new sterile needle and a new sterile syringe must be used to withdraw and administer each vaccine dose to each patient 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 with local requirements.
This medicinal product is subject to medical prescription (List I).

Store in a refrigerator (2°C-8°C). Do not freeze.
Store in the original outer package, protected from light.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer in use. These measures will help to protect the environment.

Vaccines, Antisera & Immunologicals

J07BG01 - rabies, inactivated, whole virus ; Belongs to the class of rabies viral vaccines.

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