SUMMARY PRODUCT
CHARECTERISTICS
Rabies Vaccine for Human use, (Vero-cell) freeze-dried (Speeda Vaccine)
DESCRIPTION -
POTENCY Each vaccine vial contains:
Protective activity of rabies antigen ……… ≥2.5* IU
(Rabies virus L-Pasteur PV-2061 propagated on vero cell and inactivated by ß-propio
lactone)
Human serum albumin…………………………...≥5.0mg
Dextran……………………………………………………18.0mg
Each diluents ampoule contains:
Sterile water for injection ……………………….0.5 ml
*Even after exposure at 37°C for 4 weeks
THERAPEUTIC The vaccine can induce immunity against rabies virus in recipients following
INDICATIONS immunization, it is used to protect against rabies.
Pre-exposure vaccination: the persons at risk of contacting rabies virus shall be
vaccinated following the pre-exposure schedule, such as laboratory personnel handling
materials contaminated with rabies virus, they should be vaccinated, done the serum test
every 6 months, need another booster injections if the anti-body titer in the serum is less
than 0.5 IU/ml. The vaccination is also necessary to the veterinarians and their assistants,
animal feeders, gamekeepers, hunters, forestry workers, children in enzootic areas,
travelers planning to stay in enzootic areas.
Post-exposure: the persons are bitten or scratched by a rabid dog or other rabid animals.
The treatment is adapted to the type of wound and the status of the animal.
DOSAGE & METHOD To reconstitute the vaccine, introduce the diluents 0.5 ml into the vial of powder and
OF shake thoroughly until the powder is dissolved completely. The solution should be
ADMINISTRATION homogenous, clear and free of any particles. Withdraw the solutions in a syringe.
1. Intra-muscular administration: the 0.5 ml dose shall be injected intra-muscularly
in the deltoid in anterio-lateral region of the thigh in young children. Do not
inject in the gluteal region.
2. Intra-dermal administration: the 0.1 ml dose of vaccine (per site) shall be
injected intradermally in the upper arm.
Pre-exposure schedule:
3 injections on day 0, day 7 and day 28.
The injection schedule on day 28 may be administered on day 21.
Post-exposure schedule:
1. Auxiliary therapy:
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 quantity of
water and soap and with detergent and then apply 70% alcohol, tincture of
iodine or 0.1 % quaternary ammonium solution provided no soap remains as the
two products neutralize each other. Curative vaccination must be administered
under medical supervision and only in rabies treatment centre.
2. Vaccination of non-immunized subjects:
2.1 Intra-muscular schedule
5 injections (0.5ml will be given intra-muscularly on day 0, 3, 7, 14 and 28
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2.2 Intra-dermal schedule
1 dose of vaccine, in a volume of 0.1ml is given intra-dermally at two
different sites usually the left and right upper arm on days 0, 3,7 and 28
In case of type 3, anti rabies immunoglobulin should be administered as well on day 0.
The anti rabies immunoglobulin 20 IU/kg of specific human rabies immunoglobulin or
40 IU/kg of purified rabies serum of equine origin should be used as local wound
soakage injection as much as possible, with the rest part for muscle injection. The rabies
vaccine should be administered in different injection site.
3. Vaccination of subjects already fully immunized against rabies:
3.1 If vaccine administered in less than 6 months of exposure (cell culture rabies
vaccine), then one injection on day 0 is recommended.
3.2 If vaccine administered in more than 6 months of exposure (cell culture
rabies vaccine), then two injections on day 0 and day 3 are recommended.
CONTRAINDICATONS Post-exposure therapy immunization:
Because rabies is a fatal disease, there are no contraindications for immunization,
including pregnant women.
Pre-exposure prophylaxis immunization:
The person who is pregnant or in the active period of acute fever is recommended to
delay the vaccination; the person who has serious chronic disease, disease of the nervous
system hypersensitive disease or has a allergic history of antibiotic, biological product
should avoid use.
SPECIAL WARNINGS 1. Intra-venous injection is prohibited
& PRECAUTION FOR 2. The vaccine and anti rabies immunoglobulin must not be administered with the
USE same syringe and in the same injection site
3. Before use, please carefully check the package, level, appearance and the
validity period
4. After reconstitution, the freeze-dried rabies vaccine should be administered as
soon as possible
5. In the event that the dose of vaccine inadvertently given subcutaneously or intra-
muscularly, a new dose should be administered intra-dermally immediately
6. For the intra-dermal route, sterile syringe with fixed needle (insulin type) is
preferred. A sterile needle and syringe must be used to withdraw and administer
each dose of vaccine for each patient to avoid cross infection. Correct intra-
dermal injection should result in a raised papule with a “paeu d’orange” (orange
peal) appurtenance. If the vaccine has been injected too deeply and a papule is
seen, the needle should be withdrawn and reinserted nearby
7. This vaccine does not contain a preservative, therefore, grate care must be taken
to avoid contamination of reconstituted vaccine
8. Any reconstituted vaccine should be used as soon as possible
9. It must be stored in a refrigerator at +2 to +8°C and used within 8 hours after
reconstitution or discarded
10. The intra-dermal route must not be used in the following instance:
1 0.1 Individuals receiving long term corticosteroid or other immune
suppressive therapy or chloroquine
10.2 Immunocompromised individuals
10.3 Individuals, particularly children with severe, specially to the head and
neck or presenting late for consultation
INTERACTION WITH In the case of corticosteroid and immunoinhibitor applied, they can affect antibody to be
OTHER MEDICAL produced and cause immunization failure. So such patients need to do the antibody
PRODUCTS & OTHER neutralization test between 2nd and 4th week after the last vaccination.
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FORM OF
INTERACTION
PREGNANCY & The person who is pregnant or in the active period of acute fever is recommended to
LACTATION delay the vaccination.
UNDESIRABLE 1. Local reactions like pain, redness, edema, pruritus and indurations in the
EFFECTS injection site. The symptoms will be alleviated without treatment after injection.
2. Systemic reaction: like a little fever, chill, asphyxia, atony, giddy, arthralgia,
muscle pain, gastrointestinal disorder.
3. The serious adverse reactions like rear anaphylaxis like tetter, nettle rash should
be properly treated under the doctor’s instruction.
STORAGE OF Store between +2°C and + 8°C.
VACCINES DO NOT FREEZE
PRESENTATION Box of 1 dose contains:
1 vial of 1 dose vaccine, diluents 1 ampoule 0.5ml, and 1 disposable syringe
Box of 5 dose contains:
5 vials of 1 dose and 0.5 diluents ampoules
MARKETING Imported and Distributed by: Namsey Pharmaceuticals And Medical Supplies
AUTHORIZATON Manufactured by: Liaoning Cheng Da Biotechnology Co., Ltd., Xingfeng Street,
HOLDER Hunnan New District, Shenyang China, 110179
PRODUCT BHU-DRA/B02658
REGISTRATION
NUMBER
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