Rabies-The Fatal Encounter “Prevention is the only solution” Rabies is probably the most feared of all human diseases. This the only disease where prophylaxis can be provide complete protection.

Interesting Historical Facts One of the oldest disease known to mankind Oriental physicians : 3000 BC Greek physician Democritus in 500 BC and Celsus in First Century AD In India, rabies is known since Vedic periods as corroborated in Antherva Veda The Latin word “Rabies” seems to have originated from the Sanskrit word “Rabhas” which means “to do violence” The vaccine developed by Dr.Louis Pasteur was first administered on July 6, 1885 Notes: Rabies has plagued man since ancient times and thus is one of the oldest disease known to mankind. The ancient Oriental physicians described a disease resembling to rabies in dogs and man as far back as 3000 BC. Rabies in animals has also been described in detail by Democratus nearly 500 years BC and Celsus during the first century AD. In India rabies is known since Vedic periods and have been described in Antherva Veda. Yama, the God of Death has been shown to be attended by dogs as his constant companions and as emissaries of death. The latin word “rabies” or “rabere” seems to have originated from sanskrit word “rabhas” which means “to do violence” On historical date of July 6th 1885, Dr. Louis Pasteur administered the first Anti rabies vaccine. In fact he vaccinated three persons, of these, the condition of a young boy, Joseph Meister had 14 rabid dog bites, was hopeless. However, Pasteur tried this vaccine for the first time on him and Joseph has gone down the history as the first person saved from death, by vaccination against rabies.

Incidence World Canine rabies continues to exist in 87 countries or territories of the world and this accounts for 99 per cent of all human rabies cases. Globally each year, 10 million people require Post-Exposure Treatment (PET) 70,000 people per annum fall victim to the disease, particularly in developing countries Notes: Rabies is widespread through out the world. Canine rabies continues to exist in 87 countries or territories of the world and this accounts for 99 per cent of all human rabies cases. Globally each year, 10 million people require Post-Exposure Treatment (PET) after the exposure of virus and in spite of that… 70,000 people per annum (approx. 200 per day), fall victim to the disease, particularly in developing countries where infected person cannot always benefit from the correct vaccination. The exact number of deaths due rabies is probably even higher as cases of rabies are not always diagnosed.

Incidence India Estimated 30,000 patients suffer painful deaths per annum, More than 67% of all reported cases of rabies come from India. Approximately 20 million dogs in India and in addition there is also threat from cats and other domestic and wild animals 5,00,000 undergo anti-rabies immunization Notes: Rabies is responsible for tremendous mortality and morbidity in India. Though the exact figures are not available it is estimated that 50,000 patients suffer painful deaths from rabies in India. The overwhelming number of victims in India belong to the age group 1-24 years. It is just impossible to visualize the physical and psychological trauma inflicted on a person bitten by a rabid animal. The large population of dogs approximately 20 million in India makes the chief reservoir of rabies. In addition, there is a threat from cats and other domestic and wild animals. This results in a loss of 4.2 million man-days per year, and incalculable loss to the state exchequer, which provides the vaccine free of cost to persons bitten by suspected rabid animals. A survey conducted in 41 medical colleges shown the admission rate of a case with hydrophobia as 1 out of 2000 total admissions. With the exception of Andaman and Nicobar and Lakshadweep islands, human cases of rabies in India are reported from all over the country and through out the year.

What is Rabies ? Highly fatal viral disease, characterized by inflammation of the central nervous system (encephalomyelitis) Known as hydrophobia Primarily a zoonotic disease-All warm-blooded animals are susceptible to this infection Extremely dangerous disease: characteristic long and variable incubation period, a short period of illness, highly distressing symptoms and as a rule ending in death It is the only communicable disease of man that is always fatal. Notes: Rabies is a highly fatal, acute viral infection characterised by inflammation of central nervous system (Encephalomylitis). It is also known as hydrophobia. Rabies is primarily a zoonotic disease and all warm blooded animals are susceptible to this infection, particularly carnivorous animals such as dogs, cats, jackals and wolves. Rabies is an extremely dangerous disease with a long and variable incubation period and a short period of illness. It is characterized by highly distressing and aggressive symptoms and as a rule ending in death, despite of intensive care. Rabies is the only communicable disease of man that is always fatal.

Agent factor The causative agent : Lyssavirus type 1 Belongs to the family Rhabdoviridae –Serotype 1 Bullet shaped neurotropic RNA containing virus Two major antigens : Glycoprotein (gp) – cell membrane Nucleoprotein antigen (N protein) Only gp induces virus-neutralizing antibodies Notes: The causative agent is called as Lyssavirus type 1 This virus belongs to the genus Lyssa virus and family Rhabdoviridae The rabies is a bullet shaped small virus of an approx size of s-200 X 80 nano meter, containing neurotropic RNA. Rabies virus contains two distinct major antigens called Glycoprotein antigen from the virus cell membrane and internal nucleoprotein antigen. The glycoprotein antigen seems to be the only antigen capable of inducing the formation of virus neutralizing antibodies.

Agent factor Other important properties: The virus is highly resistant against cold, dryness, decay, etc. It can remain infectious for weeks in cadavers Its is inactivated by formaldehyde, sunlight, lipid solvents and antiseptics Notes: There are some other important properties of this virus, some them have clinical significance in the prevention of rabies: The virus is highly resistance against cold, dryness, decay etc. It can remain infectious for weeks in cadavers(dead animals/body). Therefore, even the dead rabid animal can transmit the disease, and thus its has to very carefully disposed. It is inactivated by formaldehyde, sunlight, lipid solvents and antiseptics. This property is important for the treatment of wounds during the post exposure treatment.

Host and Source of Rabies Infection Host or Principal Reservoirs All warm-blooded animals In cities-dogs and cats Source of infection: -saliva of rabid animals -virus in saliva: 3-4 days before the onset of symptoms and during the course of illness in dogs and cats Notes: Host or Principal Reservoir Rabies is primarily a disease of animals and almost all warm blooded animals fall prey to it There may be a variation in the susceptibility of different animals, it can be safely said that the rabies can infect all mammals The main source of infection for man in cities are dogs and cats. In India the dog is a principal reservoir of rabies and as many as 96% of the persons undergo antirabies treatment in this country were bitten by dogs. Cats, Monkeys, Mongoose, Jackals and Cattle are other animals which are responsible for spreading the disease in India. The main source of infection is saliva of rabid animal. Usually, the saliva is contaminated with rabies virus, 3 to 4 days before the onset of symptoms and remains during the course of illness in dogs and cats.

Mode of transmission Animal bites: 99% rabid dog bites -Others: cat, monkey, horse, sheep, goat Licks: Abraded skin and mucosa (abraded or unabraded) Notes: The major mode of transmission for rabies infection are animal bites and licks. Among animal bites 99% are from rabid dog bites. Licks on abraded skin and mucosa can transmit the virus. Other Modes of Transmission, which are not very common are aerosols and person to person. Aerosols: Aerosols or respiratory transmission has been observed in nature only in certain caves harbouring rabies infected bats and in laboratory (aerosis created during homogenization of nervous tissue) Person-to-person: Man to man transmission, although rare, is possible. A case of child biting its parents is on records. There are also reports of transmission of rabies by corneal and organ transplant.

Incubation period In humans, highly variable : 3-8 weeks post exposure (but may vary from one week to many years) Factors influencing incubation period: The site of the bite Severity of the bite Number of wounds Amount of virus injected Species of the biting animal Protection provided by the clothing and Treatment undertaken, if any. Notes: In humans the incubation period is highly variable commonly 3-8 weeks following the exposure but may vary for one week to many years. The incubation period depends on various factors as follows:- The site of the bite Severity of the bite Number of wounds Amount of virus injected Species of the biting animal Protection provided by the clothing and Treatment undertaken, if any. In general, incubation period tends to be shorter in severe exposures and bites on face, head, neck and upper extremities and bites by wild animals. In no other specific communicable disease the incubation period is so variable and dependant on so many factors as in rabies.

Pathogenesis Brain Spinal Cord Dorsal Root Ganglia Peripheral nerves Tissues The deadly sequel Brain Body Fluids Spinal Cord Glands Dorsal Root Ganglia Notes: Virus replicates in muscle or connective tissue , near the site of introduction before it attaches to nerve endings and enters peripheral nerves The neurotropic virus spreads from the site of infection centripetally via the peripheral nerves towards the central nervous system From central nervous system, the virus spreads centrifugally in peripheral nerves to many tissues including skeletal and myocardial muscles and passes into various glands like adrenal glands and skin. It passes into salivary glands and saliva via peripheral nerves. The salivary gland invasion is crucial for the transmission of virus to another animal or human. So far the virus has not been isolated from blood of rabies patients and hence, the hematogenous root of spread is ruled out. Peripheral nerves Multiplies Locally in Muscle Fiber

Clinical manifestations First Warning Sign:Prodromal Symptoms 80% of patients complain of pain or tingling at the site of the bite-reasonably specific headache, malaise, sore throat and slight fever lasting for 3-4 days Notes: The disease begins with the first warning signs or prodromal symptoms such as pain or tingling at the site of the bite, which is experience by 80% of the patients and is reasonably specific symptom. It is also associated with headache, malaise, sore throat and slight fever lasting for 3 to 4 days.

Clinical manifestations Widespread excitation and stimulation of Nervous system : The sensory system, the motor system, the sympathetic and central nervous system Intolerant to noise, bright light or a cold draught of air (sensory) Aerophobia (fear of air) may be present Increased reflexes and muscle spasms (motor) Dilatation of the pupils and increased perspiration, salivation and lacrimation (sympathetic) Mental changes include fear of death, anger, irritability and depression Notes: The prodromal stage is followed by widespread excitation and stimulation of all parts of nervous system usually involved in order sensory system, the motor system, the sympathetic and central nervous system. The patient is intolerant to noice, bright light or a cold draught of air. Aerophobia maybe present Increased reflaxes and muscle spasms due to high motor activities leading to tremors, tonic/clonic spasms. Along with the increased motor activity there is dilatation of pupils and increased perspiration, salivation and lacrimation due to increased sympathetic activities. Mental or behavior changes includes the fear of death, anger, irritability and depression. The patient becomes either disinterested in his family or conversely showing excessive affection.

Clinical manifestations Hydrophobia: This characteristic symptom of hydrophobia (fear of water) is pathognomonic of rabies and is not characteristic in animals Duration of illness is 2-3 days (sometimes 5-6 days) Rabies can be classified as:- Furious or frank rabies Paralytic or dumb rabies Notes: The symptoms are progressively aggravated All attempts at swallowing liquid become unsuccessful and thus termed as Hydrophobia. This characteric system of hydrophobia is patho gnamonic of rabies and is not characteristic in animals. The mere sight or sound of water may provoke spasm of the muscles of deglutition The duration of illness is normally 2-3 days or may prolong to 5-6 days in exceptional cases. The patient may die abruptly during one of the convulsions or may pass on to the stage of paralysis and coma. Based on the above clinical manifestations rabies can be classified as:- Furious or frank rabies Praralytic or dumb rabies The furious or frank rabies is the more common form and characterised by high motor and sensory activities. Paralytic or dumb rabies occurs in 20% fo the cases. The noticeable symptoms are flaccid paralysis of limb which is often misdiagnosed as a case of Encephalitis.

Diagnosis On the basis of history of bite by a rabid animal and characteristic signs and symptoms Confirmation by laboratory tests: antigen detection : immunofluorescence of skin biopsy Virus isolation from saliva and other secretions Notes: A clinical diagnosis of hydrophobia can be made on the basis of history of bite by a rabid animal and characteristic signs and symptoms. Rabies can be confirmed in the patients early in the illness by antigen detection using immunofluorescence of skin biopsy. The virus isolation may be necessary for confirming the results of antigen detection tests and for further characterizing the isolated virus. Neutralising antibodies are not usually detectable in serum or cerebro spinal fluid (CSF) before 8th day.

Prevention of rabies in human WHO EXPERT COMMITTEE ON RABIES Has issued precise recommendation for the management of rabies in a technical report published in 1996 Notes: In view of extremely high fatality rate of human rabies, the prevention of rabies after exposure is of the utmost importance. Major advances have been made in the safety and potency of rabies vaccine. The committee has issued precise recommendation for the management of rabies in a technical report published in 1992.

Pre-Exposure Vaccination Post-Exposure Treatment (PET) WHO Recommendations Pre-Exposure Vaccination Post-Exposure Treatment (PET) Post-Exposure Treatment of persons who have been vaccinated previously Notes: The WHO committee recommends three important aspects of prevention of rabies Pre-Exposure Vaccination Post-Exposure Treatment Post-Exposure Treatment of persons who have been vaccinated previously.

A. Pre Exposure Vaccination: WHO Recommendations A. Pre Exposure Vaccination: High risk group: laboratory staff working with rabies virus, veterinarians, pet owners, animal handlers, wild life officers, sanitation workers, municipal employees working on rabies control projects such as dog handlers persons who handle rabies patients, medical and para-medical staff in communicable disease hospitals, naturalists, rural postmen slaughter house personnel, taxidermists, tannery workers and those who frequently travel in rabies endemic areas should undertake pre-exposure vaccination. Notes: The pre-exposure vaccination should be offered to the persons at the high risk of exposure such as:- laboratory staff working with rabies virus, veterinarians, pet owners, animal handlers, wild life officers sanitation workers, municipal employees working on rabies control projects such as dog handlers persons who handle rabies patients, medical and para-medical staff in communicable disease hospitals, naturalists, rural postmen slaughter house personnel, taxidermists, tannery workers and those who frequently travel in rabies endemic areas should undertake pre-exposure vaccination.

WHO Recommendations The advantages of pre-exposure vaccination It prepares immune system to have anaemnestic response when the actual bite takes place. It will reduce the necessity of immunoglobulin requirements as the active immunity is triggered immediately. It will reduce the risk, in case, Post- Exposure Treatment (PET) is delayed due to non-availability of vaccine in remote areas. It reduces the number of Post-Exposure Treatment doses to three instead of the usual six. Notes: The pre-exposure vaccination as recommended by WHO has many advantages under its belt:- It prepares immune system to have anaemnestic response when the actual bite takes place. It will reduce or eliminate the necessity of immunoglobulin requirements as the active immunity is triggered immediately. It will reduce the risk, in case, Post- Exposure Treatment (PET) is delayed due to non-availability of vaccine in remote areas. It reduces the number of Post-Exposure Treatment doses to three instead of the usual six.

WHO Recommendations Dosage Schedule for pre-exposure vaccination three injections of cell culture vaccines (abhayrab) with a potency of at least 2.5 IU Notes: The vaccine of cell culture origin are preferable for pre-exposure vaccination of three months since they are safer and more effective than the nervous tissue vaccine. Three full intra-muscular doses of tissue culture rabies vaccine of potency atleast 2.5IU per dose given on days 0, 7 and 28 days (a few days variation in the schedule is not important) Periodic booster injections are recommended after one year and there after once in every three years to continue the immune status Day 0 Day 7 Day 28 1 year every 3 years Continued immune status can be maintained by a booster after one year and there after a booster once in every three years

Pre-exposure Vaccination WHO Recommendations Pre-exposure Vaccination Important: Reduces the number of vaccinations(PET) considerably. High risk groups: Test the antibody titres every six months. Revaccination is recommended, if the serum antibody titre falls below 0.5 IU/ml. A rabies vaccination pre-exposure certificate should be obtained by such persons and the following details should be provided in the certificate:- 1. Type of vaccine, 2. Origin-The manufacturer, 3. Schedule used along with dates, 4. Batch number, 5. Anti- body titres (if determined) Notes: With pre-exposure vaccination, it is very important to note the following aspects:- The pre-exposure vaccination does not make redundant the necessity of PET, but reduce the number of vaccinations considerably. High risk groups are advised to test the antibody titres every six month. Revaccination is recommended, if the serum antibody titre falls below 0.5 IU/ml. A rabies vaccination pre-exposure certificate should be obtained by such persons and the following details should be provided in the certificate:-Type of vaccine, 2. Origin-The manufacturer, 3. Schedule used along with dates, 4. Batch number, 5. Anti- body titres (if determined)

WHO Recommendations B. Post Exposure Treatment (PET) “Factors that should be considered in deciding whether or not to initiate post-exposure treatment are”: The nature of exposure The presence of reported cases of rabies in the area The species of animal involved The clinical and vaccination status of the biting animal The availability of the animal for observation The results of laboratory testing of the animal, if available Notes: For the Post Exposure Treatment (PET) WHO recommends certain general considerations. WHO identifies the following “Factors that should be considered in deciding whether or not to initiate post-exposure treatment are”: The nature of exposure The presence of reported cases of rabies in the area The species of animal involved The clinical and vaccination status of the biting animal The availability of the animal for observation The results of laboratory testing of the animal, if available An apparently healthy dog or cat that bites a person may or may not justify the initiation of treatment, depending on the perceived risk. If the animal is a recognised rabies vector in the area where the contact occur, initiation of the treatment should never await the results of the laboratory diagnosis

Guide For Post-exposure Treatment 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. Nibbling of uncovered skin. Minor scratches or abrasions without bleeding. Licks on broken skin II None, if reliable case history is available. Touching or feeding animals. Licks on intact skin. I Recommended treatment Type of contact with a suspect or confirmed rabid domestic or wild animal or animal unavailable for observation Category Notes: Under the guidelines of post-exposure treatment by WHO the following three categories has been described:- Category I:- Where the type of contact with a suspect or confirmed rabid domestic or wild animal, is in the form of touching or feeding of animals or licks on contact skin, then no treatment is recommended if the reliable case history is available. Category II:- Where the contact with a suspect or confirmed rabid domestic or wild animal, is in the form of nibbling of uncovered skin, minor scratches or abrasions without bleeding, licks on broken skin, administration of vaccine is recommended immediately.

Guide For Post-exposure Treatment 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. Single or multiple transdermal bites or scratches. Contamination of mucous membrane with saliva (i.e. licks). III Recommended treatment Type of contact with a suspect or confirmed rabid domestic or wild animal or animal unavailable for observation Category Notes: Category III:- Where the contact with a suspect or confirmed rabid domestic or wild animal, is in the form of single or multiple transdermal bites or scratches, contamination of mucus membrane with saliva, that administration of rabies immunoglobulin and vaccine is recommended immediately.

B. Post Exposure Treatment (PET) WHO Recommendations B. Post Exposure Treatment (PET) 1. Local Treatment of Wound- First Aid: Animal bite wound should be washed with copious amount of running water and mild soap immediately Wound can be cleaned using ethanol, tincture iodine/ aqueous solution of iodine Suturing of wounds should be avoided Suturing; if at all required: wound should be infiltrated with rabies immunoglobulin of human or equine origin before suturing Notes: Since the rabies virus enters the human body through a bite or scratch, elimination of rabies virus at the site of infection by chemical or physical means is the most effective mechanism of protection. Immediate washing and flushing with copious amount of running water and mild soap or detergent or water alone are imperative. This procedure in fact is recommended for all bite wounds, including those unrelated to possible exposure to rabies. Since the rabies virus is very sensitive to solvents of lipids, immediate local treatment helps to decay it and thus reduces the virus load into the body to a great extent. After removal of soap, wound can be cleaned using ethanol, tincture iodine/ aqueous solution of iodine Suturing or stitching of wounds should be avoided Suturing; if at all required, wound should be infiltrated with rabies immunoglobulins of human or equine origin before suturing and minimum possible stitches should be applied.

Post Exposure Treatment (PET) WHO Recommendations Post Exposure Treatment (PET) 2. Administration of rabies immunoglobulin: Should be given for all Category III exposure(severe bites), irrespective of interval between exposure and beginning of treatment Human rabies immunoglobulin(HRIG) OR Equine rabies immunoglobulin(ERIG) may be used A skin test must be performed prior to the administration of Equine rabies immunoglobin, ERIG Notes: WHO recommends to strictly follow the following guidelines for rabies immunoglobulin administration:- Rabies immunoglobulin (RIG) should be given for all Category III exposure (severe bites, specially near the head/brain), irrespective of interval between exposure and beginning of treatment. Two kinds of rabies antibody preparation, either Human Rabies Immunoglobulins (HRIG) OR Equine Rabies Immunoglobulins (ERIG) may be used A skin test must be performed prior to the administration of Equine Rabies Immunoglobins ERIG

Post Exposure Treatment (PET) WHO Recommendations Post Exposure Treatment (PET) 2. Administration of rabies immnoglobins: As much as possible , the recommended dose should be infiltrated around the wounds, if anatomically feasible The remainder should be administered IM(into gluteal region ) in a single dose The WHO recommended dose : 40 IU/kg body weight, for rabies immunoglobulin of equine origin 20 IU/kg body weight, for immunoglobulin of human origin Notes: As much as possible of the recommended dose should be infiltrated around the wounds if anatomically feasible The remainder should be administered Intramuscular (IM), into gluteal region in a single dose The WHO recommended dose : 40 IU/kg body weight, for rabies immunoglobulins of equine origin 20 IU/kg body weight, for immunoglobulins of human origin

Post Exposure Treatment (PET) WHO Recommendations Post Exposure Treatment (PET) 3. Vaccine Administration:(Tissue-Culture) The vaccine used should have a potency of at least 2.5 IU per dose Intramuscular Schedule One dose of vaccine should be administered on days 0,3,7,14 , 28 & 90 Notes: WHO recommends the potency of the tissue culture vaccine should be of atleast 2.5IU per dose. The six-dose schedule spread over a period of three months was recommended at an International conference on Rabies , held at Essen, Germany, and is popularly known as the “Essen Schedule” One dose of vaccine should be administered on the days 0, 3, 7, 14, 30 and 90. Day 0 indicates the day on which the vaccination is started and not the day the person was bitten Irrespective of age and body weight, the dose per injection is 0.5 ml (unlike 1 ml for PECE or HDCS) for vero cell rabies vaccine. abhayrab when used on 0,3,7,14,28 and 90 days for active immunization of patients exposed to the rabid animal bites will protect 100% patients Day 0 D 3 D 7 D 14 D 28 D 90

Post Exposure Treatment (PET) WHO Recommendations Post Exposure Treatment (PET) 3. Vaccine Administration:(Tissue-Culture) All intramuscular injections must be given into deltoid region In small children, into the anterolateral area of the thigh muscle Vaccine should never be administered in the gluteal region A certificate of PET should be filled in and given to each vaccinee Notes: WHO recommends to strictly follow the following guidelines for the Vaccine Administration: (Tissue-Culture) All intramuscular injection must be given into deltoid region In small children, into the anterolateral area of the thigh muscle Vaccine should never be administered in the gluteal region A certificate of PET should be filled in and given to each vaccine (Certificate copy is provided in Annx. 2 in Product Monograph)

WHO Recommendations Pre and Post-Exposure Treatment for Immunocompromised Pateints or cases of delayed treatment Day 0:- 2 or 3 doses IM No change for other administrations concerning vaccine and RIG Notes: For immunocompromised patients or patients where the treatment has been delayed, WHO recommends to double or triple the dose of vaccine on day 0. This recommendation of doubling or even tripling the day 0 dose is valid for immunocompromised patients as well in cases of delayed initiation of treatment. There is no change in the dosage schedule and administration concerning the vaccine and RIG as recommended in previous classifications.

WHO Recommendations C. Post-Exposure Treatment of persons who have been vaccinated previously Local treatment of wounds should be carried out Persons who have previously received full pre- or post exposure treatment with a potent cell-culture vaccine Only two doses are needed (days 0 to 3) No rabies immunoglobulin recommended Notes: For the patients who have been vaccinated previously the following guide lines are recommended by WHO:- It is important and mandatory to carryout local treatment of wounds as recommended in post exposure treatment (PET) and should not be neglected just because the person has been vaccinated before the exposure. Persons who have previously received full pre- or post exposure treatment with a potent cell-culture vaccine, Only two doses are needed (days 0 to 3) No rabies immunoglobulins recommended

WHO Recommendations C. Post-Exposure Treatment of persons who have been vaccinated previously Persons who have previously received full per- or post exposure treatment with vaccine of unproven potency, and/or low anti-body titre (<0.5 IU) Should receive a complete post-exposure treatment course, including rabies immunoglobin if indicated Notes: Persons who have previously received full per- or post exposure treatment with vaccine of unproven potency, and/or low anti-body titre (<0.5 IU) Receive a complete post-exposure treatment course, including rabies immunoglobins, if indicated, as in case of all third degree bites.

abhayrab-prescribing information Composition per single dose: Freeze-dried vaccine: One immunizing dose contains the protective activity of equal to or greater than 2.5 International Units (IU) even after exposure at 37 degrees centigrade for one month.

abhayrab-prescribing information Composition per single dose: Rabies Virus (L.Pasteur 2061/Vero) propagated on Vero cell line, inactivated with beta-propiolactone(BPL). Thiomersol @ 0.015% added as preservative Maltose……………………………….q.s. per immunizing dose Human Serum Albumin ……………..q.s. per immunizing dose. Sodium Chloride (0.9%) for Injection I.P.- 0.5 ml.

abhayrab-prescribing information INDICATIONS: For active immunization against rabies both for prophylaxis and post-bite therapy in all age groups of humans For prophylactic immunization of all high risk group of persons such as veterinarians, municipal workers, medical and paramedical personnel, forest and zoo personnel, hunters, laboratory personnel working with suspected rabies material and pet owners. For immunization against rabies after exposure (after contact with a rabid or suspected rabid animal)

abhayrab-prescribing information DOSAGE:  Prophylaxis: Three immunizing doses on 0,7 and 28 (21) days followed by one annual booster and subsequently every three years  Post exposure: One immunizing dose on post exposure days 0,3,7,14,28 (30) and 90 each. (Day 0 is the day of first vaccination and not the day of bite.)

abhayrab-prescribing information ADMINISTRATION: Reconstitute the freeze dried vaccine with the diluent supplied in the ampoule Administer the reconstituted vaccine (entire quantity of the vial) by deep intramuscular route in the deltoid region or in small children, into the anterolateral region of the thigh muscle. The reconstituted vaccine should be used immediately and not to be stored for administration later.

abhayrab-prescribing information CONTRAINDICATIONS: In principle, there are no contraindications for administering the vaccine as the high risk of death outweighs all other considerations, specially in case of post-bite therapy. CAUTIONS: Concurrent use of immunosuppressive agents like corticosteroids shall be avoided as it may hamper in the development of protective antibodies. In case of severe bites, local infiltration of the wounds with antirabies immunoglobulin is recommended. Delay in the commencement of post-bite therapy, incomplete and irregular therapy can cause failure of protection.

abhayrab-prescribing information STORAGE:  To be stored at temperature between 2 to 8 degrees centigrade. Do not store the vaccine in deep freezer.  PRESENTATION: The vaccine is supplied as a single dose vial in a carton and the diluent for reconstitution is supplied separately in ampoules along with syringe & needles.

Advantages of Vero cell vaccine over Nervous tissue Highly potent and immunogenic High titres of antibodies are obtained Virtually free of side-effects ; No neuroparalytic complications Lesser number of injections per course, which are spaced and not given daily Dose per injection is also much less – 0.5ml compared to 2 to 5 ml No variation in dose according to age or body weight Convenient site of inoculation: Deltoid region is preferred

Advantages of Vero cell vaccine over Nervous tissue 8. Sterile disposable syringe or pre-filled syringe are provided with the vaccines 9. Longer shelf life 10. Freeze-dried formulation, therefore better temperature resistant 11. Can be used for pre-exposure vaccination 12. Immunity lasts up to 3-5 years 13. Can be used to immunize patients who develop allergy to nervous tissue vaccines

Advantages Over PCEC Relevant abhayrab benefits: Abhayrab is manufactured using vero cell line as a substrate and is virtually free of side effects PVCV is the latest reference vaccines by WHO Abhayrab is available as single dose vials, which can be conveniently used by the doctors Abhayrab is much economical Abhayrab is an indigenous product and thus offers assured supplies. Abhayrab requires only 0.5 ml diluent to be administered to the patients

HBI-Abhayrab Technological Expertise Nestled atop the Niligiri hills in Ooty, the ‘state-of-the-art’ vaccine production facility of Human Biologicals Institute is designed strictly as per the WHO norms Each batch of Abhayrab goes through a battery of tests at every stage ensuring that the vaccine consistently exceeds all WHO norms for purity, potency and immunogenic activity Nestled atop the Niligiri hills in Ooty, the ‘state-of-the-art’ vaccine production facility of Human Biologicals Institute is designed strictly as per the WHO norms Each batch of Abhayrab goes through a battery of tests at every stage ensuring that the vaccine consistently exceeds all WHO norms for purity, potency and immunogenic activity

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