Speeda

The Freeze-dried vaccine looks like a milky white crisp cake which turns into a transparent liquid after reconstitution.
Each vial contains: Purified Rabies Vaccine (Vero Cell) 2.5 I.U.
Freeze-dried Rabies Vaccine for Human Use (Vero cell). The vaccine is a preparation of rabies fixed virus (PV2061) produced on Vero cells, after the virus suspension is harvested followed by concentration, inactivation, purification and lyophilisation. The vaccine is formulated by adding human serum albumin and dextran. Within the period of validity, the potency of one dose is not less than 2.5 I.U.

Pharmacotherapeutic Group: Anti-rabies. Rabies Vaccine for Human Use. ATC Code: J07BG01.
Pharmacology: Pharmacodynamics: Mechanism of Action: The vaccine contains inactivated rabies virus, which stimulates the immune system to produce antibodies that protect against rabies. The virus is grown in Vero cells, then harvested, concentrated, inactivated, purified, and freeze-dried. Once administered, the vaccine induces a protective immune response by encouraging the production of antibodies that neutralize the rabies virus.
Clinical Efficacy and Safety: The vaccine is produced under strict quality controls by Liaoning Cheng Da Biotechnology Co., Ltd. It is administered intramuscularly or intradermally to provide sufficient immune protection. After reconstitution, the vaccine should be immediately used.
Pharmacokinetics: Pharmacokinetic studies are generally not required for vaccines, as they primarily function to trigger an immune response rather than undergo typical absorption, distribution, metabolism, and excretion (ADME) processes like other drugs. The inactivated rabies virus in the vaccine is recognized by the immune system, which produces antibodies without significant distribution or metabolism within the body. Therefore, the pharmacokinetics of this vaccine are not applicable according to WHO guidelines on nonclinical evaluation of vaccines.

The product can induce immunity against rabies virus in recipients following immunization, it is used to prevent rabies in human.
Eligible Persons: Pre-exposure vaccination: This vaccine is recommended for the prevention of rabies in subjects at a high risk of exposure.
*All subjects at a permanent risk, such as diagnostic, research and production laboratory staff working on a rabies virus, should be vaccinated. A serological test is recommended every 6 months. A booster injection should be administered when the antibody titer 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 vaccination: After confirmed or suspected exposure, vaccination must be started immediately at the slightest risk of contamination with rabies. Such as someone is bitten or scratched by a rabid dog or other rabid animals, victim shall be inoculated with the vaccine according to the post-exposure schedule as soon as possible.

To reconstitute the vaccine, introduce the diluent 0.5 mL into the vial of powder and shake thoroughly until the powder is dissolved completely. The solution should be homogenous, clear and free of any particles. Withdraw the solution in a syringe.
Intramuscular administration: The 0.5 mL dose of vaccine shall be injected intramuscularly in the deltoid in adults and in the anterio-lateral region of the thigh in infants and toddlers.
Do not inject in the gluteal region. Do not administer by the subcutaneous route.
Intradermal administration: The 0.1 mL dose of vaccine (per site) shall be injected intradermally in each deltoid.
Pre-exposure schedule: Primary vaccination: 3 injections on Day 0, Day 7, Day 28; Booster injection 1 year later, Booster injection every 5 years.
The injection schedule on Day 28 may be administered on Day 21.
Post-exposure schedule: 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 quantities of water and soap and with detergent and then apply 75% alcohol, tincture of iodine or a 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.
Vaccination of non-immunized subjects: Intramuscular schedule (Standard intramuscular regimen: ESSEN): Five injections (0.5 mL) will be given intramuscularly on day 0, 3, 7, 14 and 28.
Intradermal schedule (Modified TRC-ID regimen, 2-2-2-0-2): One dose of vaccine, in a volume of 0.1 mL is given intradermally at two different sites, usually the left and right upper arm on day 0, 3, 7, and 28.
In the case of type III, anti-rabies immunoglobulin should be administered as well on day 0. The anti-rabies immunoglobulin (20 IU/kg) 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.
In case of the following situation, the vaccine dose should be reduplicated on day 0 and 3.
The chronic patients suffered from tuberculosis or hepatocirrhosis have been vaccinated immunoglobulin or antiserum the day before the rabies vaccine injection or earlier.
The people whose wounded site is close to central nerve.
The patients who suffered from congenital or acquired immunity deficiency.
The elders.
The people who haven't been inoculated rabies vaccine after exposure.
Vaccination of immunized subjects: The people who have got the pre-exposure full course immunity within one year; they should be administrated one dose of vaccine on day 0 and 3 respectively in case of another exposure.
The people who have got the pre-exposure immunity and the booster immunity one year later within three years; they should be administered one dose of vaccine on day 0 and 3 respectively in case of another exposure.
The people who have got the pre-exposure immunity but didn't get booster injection after one year, or the people who have got post-exposure full course immunity one year before; they should get full course vaccination in case of another exposure.
The people who have got the pre-exposure immunity and the booster immunity one year later but it is over 3 years; they should get full course vaccination in case of another exposure.

The effects of an overdose are not known.

Post-exposure therapy immunization: Because rabies is a fatal disease, there are no contraindications for post-exposure immunization, including pregnant woman.
Pre-exposure immunization: The person who is pregnant or in the active period of acute fever is recommended to delay vaccination; the person who has seriously chronic disease, disease of the nervous system, seriously hypertensive disease or has allergic history of antibiotic, biological product should avoid use.

Intravenous injection is prohibited.
The vaccine and anti-rabies immunoglobulin must not be administered with the same syringe and in the same injection site.
Before use, carefully check package, label, appearance and the validity period.
After reconstitution, the rabies vaccine should be administered as soon as possible.

The vaccine has not been the subject of animal teratogenicity studies.
In post-exposure vaccination, due to the severity of the disease, pregnancy is not a contraindication.
In the absence of sufficient human data, it is recommended to postpone pre-exposure vaccination.
As a general rule, during pregnancy and lactation, it is recommended to always ask the doctor or pharmacist for advice before using medicinal product.

Like other vaccines, the vaccine may cause some adverse reactions to a few individuals.
Local reaction: Like pain, redness, edema, pruritus and induration in the injection site, the symptoms will be alleviated without treatment after injection.
Systemic reaction: Like a little fever, chill, asphyxia, atony, giddy, arthralgia, muscle pain, gastrointestinal disorder.
The serious adverse reactions: Rare anaphylaxis like tetter, nettle rash should be properly treated under the doctor's instructions.
Besides, any adverse reactions not mentioned in the instruction should be reported timely.

In the case of corticosteroid and immune inhibitor applied, they can affect antibody to be produced, and cause immunization failure. So such patients need to do the antibody neutralization test between 2^nd and 4^th week after the last vaccination.

Special Precautions for the Intradermal Route: It is essential that intradermal administration of this vaccine be carried out only by medical staff trained in this technique in order to ensure that the vaccine is delivered intradermally and not subcutaneously.
In the event that a dose of vaccine is inadvertently given subcutaneously or intramuscularly, a new dose should be administered intradermally immediately.
For the intradermal route a 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 intradermal injection should result in a raised papule with a "peau d' orange" (orange peel) appearance. If the vaccine has been injected too deeply and a papule is not seen, the needle should be withdrawn and re-inserted nearby.
This vaccine does not contain a preservative, therefore, great care must be taken to avoid contamination of reconstituted vaccine.
Any reconstituted vaccine should be used as soon as possible. It must be stored in a refrigerator at +2°C and +8°C and used within 8 hours after reconstitution or discarded.
The i.d. route must not be used in the following instances: individuals receiving long term corticosteroid or other immunosuppressive therapy or chloroquine; immunocompromised individuals; individuals, particularly children, with severe wounds, especially to the head and neck or presenting late for consultation.

Store at temperatures between 2-8°C.
Shelf Life: 36 months.

Vaccines, Antisera & Immunologicals

J07BG01 - rabies, inactivated, whole virus ; Belongs to the class of rabies viral vaccines.

Rx