Rabies Vaccine (Liquid)

 

DESCRIPTION
Rabies Vaccine (Adsorbed) SII RABIVAX is a sterile, cell culture derived rabies vaccine for pre- and post-exposure prophylaxis in humans. It is prepared with Pitman-Moore strain of rabies virus. The virus is propagated on human diploid cells. The virus is inactivated with b - propiolactone. After inactivation the virus is adsorbed onto aluminium phosphate. The vaccine has the appearance of a pale yellow to light pink colour. The vaccine meets the requirements of WHO when tested by the methods outlined in WHO, TRS 941 (2007).

COMPOSITION

Rabies virus (Pitman-Moore strain) adapted, grown on human diploid cells and inactivated by ß using propiolactone.
Each dose of 1 ml contains:
Potency of Rabies antigen 2.5 I.U.
Adsorbed onto aluminum Phosphate.
Al+++ not more than 1.25 mg
Preservative: Thiomersal 0.01 %
Dose: 1 ml by intramuscular injection

INDICATIONS
A. Rabies prevention in subjects exposed to a risk of contamination
This vaccination is particularly recommended for:
- Professional groups exposed to frequent contaminations.
- Veterinary surgeons including students at veterinary colleges.
- Technical personnel handling material contaminated with rabies virus.
- Personnel in abattoirs and knackers yards, taxidermists, animalists.
- Farmers, gamekeepers and forestry workers in enzootic areas and naturalists.

B. Treatment after certain or plausible rabies contamination
- Treatment of subjects bitten by rabid animals or those suspected of being so.
- Treatment of contact subject.


CONTRAINDICATIONS

Rabies vaccine adsorbed is contraindicated in persons who have had life threatening allergic reactions to previous injections of this vaccine or to components of this vaccine including thiomersal. When pre-exposure treatment is given, vaccination can be postponed in high fever, acute or chronic disease. In pregnancy benefit risk ratio should be assessed and vaccine can be deferred. When post-exposure treatment is given due to fatal course of rabies, pregnancy is not a contraindication.

WARNINGS

Do not administer vaccine by intravascular route.
Ensure that the needle does not enter a blood vessel.
Immunoglobulins and rabies vaccine should not be combined in the same syringe or injected at the same site.

DRUG INTERACTIONS
Radiation therapy, antimalarials, corticosteroids, other immunosuppressive agents and immunosuppressive illnesses can interfere with the development of active immunity after vaccination, and may diminish the protective efficacy of the vaccine. Pre-exposure vaccination should be administered to such persons with the awareness that the immune response may be inadequate. Immunosuppressive agents should not be administered during post-exposure therapy unless essential for the treatment of other conditions. When rabies post-exposure prophylaxis is administered to persons receiving corticosteroids or other immunosuppressive therapy, or who are immunosuppressed, it is important that a serum sample on day 14 (the day of the fourth vaccination) be tested for rabies antibody to ensure that an acceptable antibody response has been induced.

SIDE EFFECTS
With HDC the risk of side effects are lower. However, some possible side effects are :
Local minor reactions like : Redness, induration and swelling may occur which subside within 24 to 48 hours. Fever may occur in some cases. Occasionally rare side effects like arthralgia, myalgia, headache/dizziness,nausea, GI disorders may occur.

DOSAGE AND ADMINISTRATION
In adults, administer Rabies vaccine by IM injection into the deltoid muscle. In small children and infants, administer vaccine into the anterolateral zone of the thigh. The gluteal area should be avoided for vaccine injections, since administration in this area may result in lower neutralizing antibody titers.
The vaccine vial should be well shaken before use. The dosage is 1 ml for adults and children.
Do not inject intravascularly.
The vaccine vial monitor (VVM), if attached, has not reached the discard point (see figure).
The vaccine should be visually inspected for any foreign particulate matter and / or variation of physical aspect prior to administration. In event of either being observed, discard the vaccine.

A. PRE-EXPOSURE IMMUNIZATION:
Pre-exposure prophylaxis consists of 3 intramuscular doses of 1 ml to be given on days 0, 7 and 21 or 28. For adults and children aged 2 years, the vaccine should always be administered in the deltoid area of the arm; for children aged < 2 years, the anterolateral area of the thigh is recommended.
W.H.O. recommends persons at a permanent risk, diagnostic research and production laboratory staff working with rabies virus, must be vaccinated. A serological test every six months is recommended. A booster injection should be administered when the anti body titre falls below the limit considered to be protective: 0.5 IU per ml by RFFIT. Periodic booster injections are recommended as an extra precaution only for people whose occupation puts them at continual or frequent risk of exposure. If available, antibody monitoring of personnel at risk is preferred to the administration of routine boosters. For people who are potentially at risk of laboratory exposure to high concentrations of live rabies virus, antibody testing should be done every 6 months. Those professionals who are not at continual risk of exposure through their activities, such as certain categories of veterinarians and animal health officers, should have serological monitoring every 2 years. Because vaccine-induced immunity persists in most cases for years, a booster would be recommended only if rabies virus neutralizing antibody titres fall to < 0.5 IU/ml. Considering the satisfactory antibody titres observed with SII RABIVAX, if serological tests cannot be conducted due to cost considerations or inaccessible medical facilities, a booster dose one year after primary immunization followed by the one dose every 5 years would be advisable.

B. POST EXPOSURE IMMUNIZATION:
The essential components of rabies post-exposure prophylaxis are prompt local treatment of wounds and administration of both Human Rabies Immune Globulin (HRIG) and vaccine.
First aid or local treatment consists of immediate thorough flushing and washing of the wound with water, or soap and water followed by the application of 70 % alcohol (700 ml per litre) or tincture or povidone iodine.
A full post-exposure regime is indicated if vaccination was not documented or incomplete or if the last booster dates over 5 years. According to the degree and severity of bite, in cases of severe bites (class III WHO category), 20 I.U./kg body weight of specific rabies immunoglobulin of human origin (HRIG) or 40 IU per kg body weight of equine rabies immunoglobulin (ERIG) should be given after a sensitivity test in conjunction with vaccine on day 0. If rabies immunoglobulin is not available at the time of the first dose of the vaccine, it must be administered not later than 7 days after the first vaccination. The dose of rabies immunoglobulin should not exceed the recommended dose.
If anatomically feasible, the FULL DOSE of HRIG should be thoroughly infiltrated in the area around and into the wounds. Any remaining volume of HRIG should be injected IM at a site distant from rabies vaccine administration. HRIG should never be administered in the same syringe or in the same anatomical site as the rabies vaccine.
1) Unimmunized or incompletely immunized individuals:
The post-exposure vaccination schedule consists of injecting 1 ml into the deltoid muscle (or anterolateral thigh in children aged < 2 years) of patients with category II and III exposures. The recommended regimen consists of a 5-dose schedule:
1 dose on each of days 0, 3, 7, 14 and 28;
2) Previously fully immunized individuals:
In those previously immunized by complete preventive vaccination (pre-exposure vaccination or post-exposure treatment): 2 doses of 1 ml given by intramuscular route one each on day 0 and day 3 are recommended. No HRIG should be administered to previously vaccinated persons as it may blunt their rapid memory response to rabies antigen.
3) Immunocompromised individuals:
Patients receiving immunosuppressive therapy, or who have congenital or acquired immunodeficiency, should be vaccinated once on each of the days 0, 3, 7, 14, 28. In addition, the initial immunisation dose (day 0) should be doubled with a single dose of vaccine being administered as soon as possible after exposure into each of the right and left deltoid muscles (upper-arm muscle) or, in small children, into the anterolateral region of each of the right and left thighs.
If immunocompromised patients (with impaired defence system ) are treated after exposure to rabies, it is advisable that the antibody titre be measured 14 days after the first dose. If a titre of at least 0.5 IU/ml, which is considered adequate to confer protection, is not present, a dose of vaccine should be immediately administered into each upper-arm (or into each thigh in the case of small children). Depending on the immunisation status of these patients, additional doses may be necessary to achieve appropriate antibody titres in serum.

STORAGE
The vaccine should be stored between 2° C and 8° C.
Do not freeze. Discard if the product has been frozen.

SHELF LIFE
Two years.

PRESENTATION
SII RABIVAX is available as ampoules / vials containing
1 ml - 1 dose carton plus sterile disposable syringe and needle
1 ml x 5 vials carton
1 ml x 5 ampoules carton
1 ml x 50 ampoules/vials carton
1 ml x 50 ampoules carton

THE VACCINE VIAL MONITOR (Optional)

 

Inner square lighter than outer circle.
If the expiry date has not passed, USE the vaccine.

 

At a later time, inner square still lighter than outer circle.
If the expiry date has not passed, USE the vaccine.

 

Discard point:
Inner square matches colour of outer circle.
DO NOT use the vaccine.

 

Beyond the discard point:
Inner square darker than outer ring.
DO NOT use the vaccine.

Vaccine Vial Monitors (VVMs) are part of the label on Rabies Vaccine supplied through Serum Institute of India Ltd. The colour dot which appears on the label of the vial is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the ring, then the vaccine can be used. As soon as the colour of the central square is the same colour as the ring or of a darker colour than the ring, then the vial should be discarded.


WHO GUIDE FOR POST EXPOSURE TREATMENT

Category
Type of contact with a suspect or confirmed rabid domestic or wild animal, or animal unavailable for observation.
Recommended treatment
I
Touching or feeding of animals.
Licks on intact skin
None, if reliable case history is available
II
Nibbling of uncovered skin. Minor scratches or abrasions without bleeding
Administer vaccine immediately.
Stop treatment if animal remains healthy throughout an observation period of 10 days or if animal is killed humanely and found to be negative for rabies by appropriate laboratory techniques.
III
Licks on broken skin
Single or multiple transdermal bites or scratches
Contamination of mucous membrane with Saliva (i.e. licks)
Administer rabies immunoglobulin and vaccine immediately.
Stop treatment if animal remains healthy throughout an observation period of 10 days or if animal is killed humanely and found to be negative for rabies by appropriate laboratory techniques.

 

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