Verorab

/ Medici

The recommended dose is 0.5 mL of reconstituted vaccine intramuscularly (IM) or 0.1 mL of reconstituted vaccine intradermally (ID) in each injection site.
Pre-Exposure
This medical product 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
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 for already vaccinated individuals
According to 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-derived vaccine.
Previously vaccinated individuals must receive one dose of vaccine (0.5 ml intramuscularly or 0.1 ml intradermally) on the day of study entry and one dose on the day of study entry. Alternatively, 4 intradermal injections of 0.1 ml can be given at 4 separate sites on the day of the study. Rabies immunoglobulin is not suitable in this case.
People with a suppressed immune system:
* Pre-exposure prophylaxis
A 3-dose regimen should be used and serology 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 full post-exposure vaccination regimen should be given. Rabies immunoglobulin should be given concurrently with vaccination in the event of exposure to Category II or III as defined in the physician’s leaflet.
Method of administration
Intramuscular 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.
Intradermal use (ID)
The vaccine is administered preferably in the upper arm or the forearm.
Do not inject in the buttocks region.
Do not inject via the intravascular route.

Pre-exposure and post-exposure prophylaxis of rabies in all age groups.

Pre-exposure prophylaxis
* Hypersensitivity to the active substance(s) or to any of the excipients, to polymyxin B, to streptomycin, to neomycin or to any antibiotic of the same class to a previous administration or to any vaccine containing the same components.
* Vaccination should be postponed in case of febrile or acute diseases
Post-exposure prophylaxis
Given the always-fatal outcome of the declared rabies infection, there are no contraindications to post-exposure vaccination.

As with all vaccines, this medical product may not protect 100% of people vaccinated.
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.
Injection-schedule recommendations should be followed scrupulously.
Serological tests (to assess seroconversion in individuals) should be determined in accordance with official recommendations.
When the vaccine is administered in individuals with known immunodeficiency, due to an immunosuppressive disease or a concomitant immunosuppressive treatment (including corticosteroids), blood tests must be performed 2 to 4 weeks after vaccination.
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 individuals with a known hypersensitivity to polymyxin B, to streptomycin, to neomycin or to any antibiotic of the same class.
As with all injectable vaccines, it should be administered with caution in individuals with thrombocytopenia or coagulation disorders as intramuscular injection may induce bleeding in these individuals.
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.
Paediatric population
The potential risk of apnoea with the need for respiratory monitoring for 48-72 hours 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

Blood and lymphatic system disorders:
Common: lymphadenopathy.
Nervous system disorders:
Very common: Headache, irritability (paediatric), somnolence (paediatric)
Common: Insomnia (paediatric)
Musculoskeletal and connective tissue disorders:
Very common: myalgia.
General disorders and administration site conditions:
Very common: Injection-site pain, injection-site erythema (ID use), injection site swelling (ID use in paediatric), malaise, inconsolable crying (paediatric).
Common: injection-site erythema (IM use), injection-site pruritus, injection site swelling, injection-site induration, influenza-like syndrome, fever.
See prescribing information for full details.

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.
This medical product 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.

Pregnancy: Data on the use in pregnant women are limited.
Pre-exposure prophylaxis: Given the seriousness of the disease, vaccination should be given to pregnant women only if clearly needed and following an assessment of the risks and benefits, in compliance with the usual vaccination schedule.
Post-exposure prophylaxis: Given the seriousness of the disease, the vaccine can be administered during pregnancy.
 Lactation: It is unknown whether this medical product is excreted in human milk. No risk has been identified and is anticipated for infants receiving breast milk. It can be administered to breast-feeding women following an assessment of the risks and benefits.

No cases of overdose were reported.

Incompatibilities: The rabies immunoglobulins and the rabies vaccine must never be combined in the same syringe or injected at the same injection site.
This medicinal product must not be mixed with other medicinal products or other vaccines.
Shelf life: After reconstitution, the vaccine must be administered immediately.
Storage: Store in a refrigerator (2°C-8°C). Do not freeze.