Rancangan Leaflet

VERORAB
Purified Inactivated Rabies Vaccine, Prepared on Vero Cells

Composition
For one immunizing dose:
• Powder :
- Freeze-dried rabbies vaccine (WISTAR strain RABIES PM/WI 38-1503-3M) produced on
VERO cell line, inactivated and purified...........................................1 immunizing dose*
- Maltose ...............................................................................................up to 1 immunizing dose
- Human Plasma Albumin.....................................................................up to 1 immunizing dose
• Diluent : - 4% sodium chloride solution`...........................................0,5 mL
*Such that protective power is greater than or equal to 2.5 IU before and after heating for 1
month at 370C.

PHARMACEUTICAL DOSAGE FORM

Powder and diluent for suspension for injection.

MARKETING AUTHORIZATION HOLDER

AVENTIS PASTEUR SA
2, avenue Pont Pasteur, F-69007 LYON, France.

INDICATIONS
This medicinal product is vaccine.
Pre-exposure
This vaccine is recommended for the prevention of rabies in subjects at high risk of exposure.
All subjects at a permanent risk, such as diagnostic, research and production laboratory staff
working on rabies virus, should be vaccinated. A serological test is recommended every 6
months. A booster injection should be administered when the antibody titre is below the level
considered to guarantee protection 0,5 IU/mL.
The following categories should be vaccinated given the frequency of exposure to the risk.
− Veterinarians (and assistants), gamekeepers, hunters, forest rangers, slaughterhouse
personnel , cavers, taxidermists.
− Subjects exposed enzootic areas: children, adults and travelers visiting these areas.
Post-exposure
After confirmed or suspected exposure, vaccination must be started immediately at the slightest
risk of contamination with rabies. It must be performed in a rabies treatment centre.
The treatment is adapted to the type of wound and the status of the animal.
Table 1
Course of Action
Circumstances Remarks
For the Animal For the Patient
Animal unavailable Treatment by the rabies The treatment** must
Suspect or Non- treatment centre. always be completed
suspect circumstances
Dead Animal Send the brain to an Treatment by the rabies Stop the treatment** if
Suspect or Non- approved laboratory for treatment centre. the analysis are
suspect circumstances analysis negative, otherwise,
continue.
Live animal Place under veterinary Decision to postpone Continue the
Non-suspect supervision* rabies treatment treatment** according
circumstances to the veterinary
supervision of the
animal.
Suspect circumstances Place under veterinary Treatment by the rabies Stop the treatment** if
supervision* treatment centre. the supervision
invalidates the initial
doubts otherwise,
continue.
* In France, veterinary supervision includes 3 certificated issued on D0, D7 and D14 certifying
the absence of signs of rabies.
According to WHO recommendations, the minimum veterinary supervision observation period
is 10 days for dogs and cats.
** The treatment is recommended according to the severity of the wound: see table 2.
Table 2
Severity Type of Contact Recommended Contact
Touching of feeding animals, None, if reliable case
I
Licks on intact skin history is available
Nibbling of uncovered skin,
Administer vaccine
II Minor scratches or abrasions without bleeding,
immediately.
Licks on broken skin
Administer
Single or multiple transdermal bites or scratches.
immunoglobulins and
III Contamination of mucous membrane with saliva
rabies vaccine
(i.e. licks)
immediately.

CONTRAINDICATIONS
This medicinal product MUST NOT BE USED in the following cases:
Pre-exposure
− Severe febrile infections, acute disease, progressive chronic disease it is preferable to
postpone vaccination,
− Known hypersensitivity to any of the ingredients of the vaccine.
Post-exposure
Due to the fatal progression of declared rabies infection, there are no contraindications to
curative vaccination. Pregnancy see PREGNANCY – BREAST FEEDING section.
If there is any doubt, it is essential to consult your doctor or your pharmacist.

SPECIAL WARNINGS
Use with caution on subjects with a known allergy to neomycin (present in trace form in the
vaccine). Do not inject by the intravascular route: make sure that the needle does not enter a
blood vessel. Immunoglobulins and rabies vaccine must not be associated in the same site. A
serological test (neutralizing antibody assay using the RFFIT ( Rapid Fluorescent Focus
Inhibition Test) test, must be conducted every 2 to 3 years after the booster dose after 1 and 5
years in persons subject to discontinuous exposure according to the assessed exposure risk.
For immunodeficient subjects, this test may be conducted 2 to 4 weeks following the vaccination.
If the result of the test demonstrates an antibody titre < 0,5 IU/mL, a booster injection or an
additional injection, for immunodeficient subjects, is justified.
This vaccine must never be administered by the intravascular route.

PRECAUTION FOR USE

Inform your doctor in the event of known allergy to neomycin, due to the use of these substances
during production if there is any doubt, do not hesitate to consult your doctor pharmacist.
Keep out of the reach of children.

DRUG INTERACTIONS AND OTHER INTERACTIONS

Corticosteroids and immunosuppressor treatments may interfere with antibody production and
cause the vaccination to fail. Therefore, it is preferable to conduct a neutralizing antibody assay 2
to 4 weeks after the last injection of vaccine.
In order to avoid possible interactions between several medicinal products, any other ongoing
treatment should be systematically reported to your doctor or to your pharmacist.

PREGNANCY-BREAST FEEDING
The vaccine has not been the subject of animal teratogenicity studies.
In the absence of sufficient human data, it is recommended to postpone pre-exposure vaccination.
For the vaccination of subjects at a high risk of contamination, the benefit/risk ratio must be
assessed before administering the injection.
In post-exposure vaccination, due to the severity of the disease, pregnancy is not a
contraindication.
As a general rule, during pregnancy and lactation, it is recommended to always ask your doctor
or pharmacist for advice before using a medicinal product.

DOSAGE
The vaccinations schedule should be adapted according to the circumstances of the vaccination
and the subjects rabies immune status.
Preventive or pre-exposure vaccination
− Primary vaccination 3 injections on D0, D7, D28.
− Booster injection 1 years later.
− Booster injections every 5 years.
− The injection schedule on D28 may be administered on D21.
“Curative” vaccination (prevention of rabies after confirmed or suspected exposure)

First aid treatment

The treatment of wound is very important and must be performed promptly after the bite. It is
recommended firstly to wash the wound with large quantities of water and soap or detergent and
the apply 70% alcohol, tincture of iodine or a 0,1 percent quaternary ammonium solution
(provided that no soap remains as these two products neutralize each other).
Curative vaccination must be administered under medical supervision and only in a rabies
treatment centre.
Vaccination of non-immunized subjects
The dosage is the same for adults and for children : it include 5 x 0,5 ml injections on D0, D3,
D7, D14 and D28. In the case of category III exposure (see INDICATIONS-Table 2), rabies
immunoglobulins must be administered in association with the vaccine. Additional passive
immunization on day 0 is required with :
− Human rabies immunoglobulin (HRI) ................................20 IU/kg of body weight
− Equine rabies immunoglobulin ...........................................40 IU/kg of body weight
If possible, the vaccine should be injected on the side opposite the immunoglobulin
administration sites.
In enzootic areas, the severity of certain exposure due to the severity of the lesions and/or
location (proximity of the central nervous system, a late consultation or immunodeficiency of the
subject may justify, depending on the case, 2 injections on D0.
Vaccination administered less than 5 years previously (cell culture rabies vaccine): 2 injections :
D0, D3.
Vaccination administered over 5 years previously or incomplete: 5 injections: D0, D3, D7, D14
and D28 with administration of immunoglobulins if required.
In practice, if the last booster dose was administered over 5 years previously or if the vaccination
is incomplete, the subject is considered to have an uncertain vaccination status.

MODE AND ROUTE OF ADMINISTRATION

To reconstitute the vaccine, introduce the diluent into the vial powder and shake thoroughly until
the powder is completely suspended. The solution should be homogenous, clear and free of any
particles. Withdraw the solution in a syringe.
The vaccine must be injected immediately after reconstitution and the syringe must be destroyed
after use.
The vaccine is administered by the intramuscular route only in the deltoid in adults and in the
antero-lateral region of the thigh muscle in children. Do not inject in the gluteal region.

SIDE EFFECTS
As for any active product , this medicinal product may induce undesirable effects to a varying
degree in certain subjects :
− Minor local reactions: pain, erythema, oedema, pruritus and induration at the injection point.
− Systemic reactions: moderate fever, shivering, faintness, asthenia, headaches, dizziness,
arthralgia, myalgia, gastro-intestinal disorders (nausea, abdominal pains).
− Exceptionally, anaphylactoid reactions, urticaria, rash.
Report to your doctor or to your pharmacist any unwanted and disturbing effects which, might
not be mentioned in this leaflet.

STORAGE
Do not exceed the expiry date stated on the external packaging.

SPECIAL PRECAUTIONS OF STORAGE

Keep between +20C and +80C (in refrigerator)

Imported by :
PT. Aventis Pharma, Jakarta, Indonesia
For PT. BIO FARMA, Bandung.

Harus dengan resep dokter

Reg No. DKI8859700643A1

Manufactured by
Sanofi Pasteur, SA, France.