Verorab (Inactivated Purified Rabies Vaccine)

Verorab (Inactivated Purified Rabies Vaccine) Dosage/Direction for Use

rabies vaccine

Manufacturer:

Kalventis Sinergi Farma
Full Prescribing Info
Dosage/Direction for Use
Posology: Once the vaccine is reconstituted with 0.5 mL of solvent, one intramuscular (IM) dose consists of 0.5 mL of reconstituted vaccine and one intradermal (ID) dose consists of 0.1 mL of reconstituted vaccine per injection site.
Pre-exposure prophylaxis: For pre-exposure immunization, individuals can be vaccinated according to the vaccination schedules presented in Table 1 and according to official local recommendations when available. (See Table 1.)


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Post-exposure prophylaxis: Post-exposure prophylaxis includes local non-specific treatment of the wound, vaccination and, where appropriate, passive 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 vaccine or rabies immunoglobulins, when 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 2, WHO recommendations).
Post-exposure prophylaxis should be performed as soon as possible after exposure under medical supervision and only at rabies treatment center. If necessary, post-exposure prophylaxis can be supplemented by tetanus prophylaxis and antibiotic therapy to prevent the development of infections other than rabies. (See Tables 2 and 3.)


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Post-exposure prophylaxis of previously non-immunised subjects: Individuals not previously immunized can be vaccinated according to one of the vaccination schedules presented in Table 4: (See Table 4.)


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Immunogenicity and safety data in children < 2 years old are limited (see Pharmacology: Pharmacodynamics: Clinical studies under Actions).
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 concomitantly with the vaccine, in case of category II exposure (WHO classification, see Table 2). If possible, the vaccine should be administered contralaterally to the immunoglobulin administration sites.
Refer to the Summary of Characteristics of the rabies immunoglobulins used.
In enzootic areas, the severity of certain exposures due to the severity of the lesions and/or location (proximity of the central nervous system), a late consultation or immune deficiency of the subject may justify, depending on the case, 2 injections on D0.
Post-exposure prophylaxis of previously immunized 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.
These individuals should receive one dose of vaccine intramuscularly (vaccine dose 0.5 mL) or intradermally (vaccine dose 0.1 mL) on each of days 0 and 3.
Rabies immunoglobulin is not indicated for previously immunized individuals.
Paediatric population: Children should receive the same doses as adults.
Method of administration: Precautions to be taken before handling or administering the medicinal product.
The vaccine is administered via the intramuscular route, in the anterolateral region of the thigh muscle in infants and young children and in the deltoid muscle in older children and adults.
It can also be administered by intradermal (ID) route preferably on upper arm or forearm. Do not inject in the buttocks region.
Do not inject via the intravascular route.
For instructions on reconstitution of the medical product before administration, see Special Precautions for Disposal and other Handling under Cautions for Usage.
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