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ורוראב VERORAB (RABIES, INACTIVATED, WHOLE VIRUS)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-שרירי : I.M

צורת מינון:

אבקה וממס להכנת תרחיף להזרקה : POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Indications : התוויות

4.1.       Therapeutic indications
Verorab is indicated for the prevention of rabies in children and adults. It can be used before and after exposure to the rabies virus, as a primary vaccination or as a booster dose.

Pre-Exposure Prevention of Rabies (Pre-Exposure Vaccination)
Pre-exposure vaccination should be offered to subjects at high risk of contamination by the rabies virus.
All those at permanent risk, such as the personnel of a diagnostic, research or production laboratory working with the rabies virus, should be vaccinated. A serological test is recommended every 6 months (see section 4.4) .
Pre-exposure vaccination should also be considered for subjects at frequent risk of exposure to the rabies virus, such as:
-       veterinarians, veterinarians’ assistants, and animal handlers -       those who, either by profession or leisure activity, are in contact with species such as dogs, cats, skunks, raccoons, bats or other species likely to have rabies. Examples of such people are gamekeepers, hunters, forestry workers, speleologists and taxidermists .
-       adults and children living or travelling in enzootic areas.
A serological test can be performed every 2 to 3 years for those subject to discontinuous exposure .
In areas where the enzootic level of rabies is low, veterinarians and their assistants (including students), animal handlers and wildlife officers (gamekeepers) are considered to be at occasional risk of exposure and should receive a primary vaccination against rabies.
Serological tests for rabies antibodies should be performed at regular intervals in accordance with the subject’s risk of exposure.

Systematic booster injections should be administered in accordance with the subject’s risk of exposure. The frequency of booster injections is described in section 4.2.

Post-Exposure Prevention of Rabies (Post-Exposure Vaccination)
Upon the slightest risk of rabies contamination, post-exposure vaccination should be performed as soon as possible .

In some countries, vaccination must be performed in a specialized rabies treatment centre. Post-exposure treatment includes local, non-specific treatment of the injury, passive immunisation with rabies immunoglobulins (RIGs) and vaccination, depending on the type of injury and the status of the animal (see Tables 1 and 2).


Table 1: Course of Action Depending on the Status of the Animal
Circumstances        Course of Action        Comments
Regarding
The animal                   The patient
Animal unavailable                                         To be taken to a            Treatment(b) is always completed Suspect or non-                                           rabies treatment suspect                                                centre for treatment circumstances
Dead animal Suspect or           Send the brain to an          To be taken to a             Treatment(b) is discontinued if the non- suspect                     approved laboratory for       rabies treatment                 analyses are negative or, circumstances                    analysis                      centre for treatment.       otherwise, continued Live animal Non-suspect          Place under veterinary        Decision to delay                 Treatment(b) is adapted circumstances                    supervision(a)                rabies treatment                 according to the results of veterinary supervision of the animal
Suspect                       Place under                 To be taken to a                     Treatment(b) is circumstances                    veterinary   supervision(a)   rabies treatment            discontinued if veterinary centre for treatment.       supervision invalidates the initial doubts, or, otherwise, continued

(a)     Veterinary supervision includes 3 certificates, drawn up on D0, D7, and D14, declaring the absence of signs of rabies.
According to WHO recommendations, the minimum observation period under veterinary supervision for dogs and cats is 10 days.
(b)     Treatment is recommended depending on the severity of the wound: see Table below.

Table 2: WHO Guidelines on Post-Exposure Treatment Depending on Wound Severity Category    Type of contact with a wild(a) or domestic           Recommended treatment of      animal presumed or confirmed rabid or an severity       animal that cannot be placed under supervision
I           Touching or feeding of animals               None, if a reliable case history can Licks on intact skin                         be obtained
II          Nibbling of uncovered skin                      Administer vaccine immediately(b) Minor scratches or abrasions without bleeding
Licks on broken skin
III         Single or multiple transdermal bites or      Administer rabies immunoglobulins scratches                                    and vaccine immediately(b) Contamination of mucous membrane with saliva (i.e., licks)


(a)   Contact with rodents, rabbits, or hares does not normally necessitate specific rabies treatment.
(b)   Discontinue treatment if the animal is in good health after 10 days of observation (for cats and dogs) or if, after the animal has been euthanized, the results of the search for rabies by the appropriate laboratory techniques are negative.
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SANOFI ISRAEL LTD

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140 97 31875 00

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