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![Passive Immunization
IMPORTANCE OF RIG INFILTRATION
• The anti-rabies serum/Rabies Immunoglobulin (RIG)
provides passive immunity in the form of ready-made
anti-rabies antibodies, before it is physiologically
possible for the victim to begin producing his/her own
antibodies following anti-rabies vaccination.
antibodies following anti-rabies vaccination.
• So RIG must be administered to all animal bite
patients with Category III bite. [Incubation period of
rabies is shorter here].](https://image.slidesharecdn.com/guidelinerabiesprophylaxispptpdf-230108055408-ecb6cb8b/75/Guideline_Rabies_prophylaxis_PPT_PDF-pdf-17-2048.jpg)
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- 1. Guidelines on RabiesProphylaxis National Rabies Control Programme National Rabies Control Programme National Rabies Control Programme National Rabies Control Programme PH & CD BRANCH DIRECTORATE OF HEALTH SERVICES GOVT. OF WEST BENGAL 2019 2019 2019 2019
- 2. Introduction • 20,000 Deaths,17.4 million animal bite cases annually. (APCRI 2004) • India accounts for 36% of the Global and 65% of the Asian human rabies deaths. Rabies is reported from all states except Lakshadweep and the Andaman & Nicobar Islands. Rabies in India • No age or sex predilections (higher incidence of animal bites and rabies deaths among children and adult males). • 96% of human rabies cases are due to bites from Rabid dogs.
- 3. Decision to treat •Disease is endemic in India • Suspect all animal bites • Suspect all animal bites • Treat as per merits of the bite
- 4. Observation of animals •Valid only for dogs and cats • Start treatment and observe • Start treatment and observe • Modify PEP
- 5. Vaccination Status ofAnimal • Unvaccinated animals are more likely to transmit rabies • Vaccinated animals can transmit if the vaccination ineffective for any reason. – improper administration – poor quality of the vaccine – poor quality of the vaccine – poor health status of the animal • One dose does not provide long-lasting immunity. • Appropriate documentation • Proper history
- 6. Domestic :- Dogs &Cats Wild : :- - Foxes & Jackals Monkeys Mongoose Bears Peridomestic :- Animal Transmitting rabies in India Not reported :- Bats* Rodents* Birds Squirrel Peridomestic :- Cows & Buffaloes Sheep & Goats Pigs Donkeys Horses Camels RabidGoat All exposures in wild are considered as category III exposures. * Bite by Bats or Rodents do not ordinarily necessitate rabies vaccination. However, bites by Bats or rodents in unusual circumstances may be considered for vaccination in consultation with an expert in the field of rabies.
- 7. PEP of immune-compromisedpatients • Patients with low CD4 (<200 counts), chemotherapy, steroid therapy, cancer patients, etc mount a significantly lower or no response • Proper and thorough wound management and antisepsis • Local infiltration of RIG • Complete course of ARV by IM route in category II and III exposures • Anti-rabies antibody estimation 14 days after the completion of course to assess the need of additional doses of vaccine.
- 8. Mode of Transmission CommonModes:- Animal Bites Licks on abraded skin/mucosa Scratches Uncommon Modes:- Uncommon Modes:- Aerosols (respiratory) transmission Organ Transplantation Ingestion ? Sexual
- 9. Structure of RabiesVirus Bullet Shaped. Enveloped Virus. Measures 75 nm x 180 nm. Numerous spikes present Numerous spikes present on the envelope, these are made up of glycoprotein. Glycoprotein necessary for viral attachment & also induce protective antibodies. Envelope (membrane bilayer) RNP G protein RNA M protein
- 10. Dorsal root ganglia Spinalcord Brain Pathogenesis Pathogenesis Salivary glands & Other organs Multiplication locally (in the muscle fibres) Peripheral nerves Dorsal root ganglia Note: The virus is neurotropic and there is no viremia in rabies. Local treatment & Local treatment & RIG RIG
- 11. Incubation Period (inman) Incubation period highly variable Ranges between 6 days to 6 years Average : 30 – 90 days Average : 30 – 90 days More than 6 months in less than 1% Bites on the head or face - upto 1 month. Bites on the extremities - upto 3 months. commonly
- 12. Category Type ofcontact Recommended Post exposure prophylaxis I Touching or feeding of animals None, if reliable case history Licks on intact skin is available. II Nibbling of uncovered skin Wound management Guide for Post-Exposure Prophylaxis II Nibbling of uncovered skin Wound management Administer anti-rabies vaccine immediately Minor scratches or abrasions Convert post exposure prophylaxis to pre exposure prophylaxis if dog/cat remains without bleeding. healthy throughout the observation period of 10 days or if it is euthanised and found to be negative for Rabies by appropriate laboratory techniques.
- 13. Category Type ofcontact Recommended Post-exposure prophylaxis III Single or multiple transdermal bites or Wound Management Administer rabies immunoglobulin scratches. and vaccine immediately. Guide for Post-Exposure Prophylaxis (Cont’d) Contamination of mucous membrane Stop treatment if dog/cat remains with saliva (i.e. licks) healthy throughout an observation Licks on broken skin period of 10 days or if it is killed humanely and found to be negative for rabies by appropriate laboratory techniques.
- 14.
- 15. Principles of Treatment •Wound treatment • Vaccination • Vaccination • Immunoglobulin/anti sera • Advice to Patient
- 16. Wound Management DO’S MECHANICAL: Washunder Running tap water CHEMICAL: Soap (Preferably detergent) Disinfectants - Povidone Iodine, spirit, household antiseptics BIOLOGICAL: Infiltrate immunoglobulins Suturing only if required (1 - 2 loose sutures) and only after administration of RIGs. DON’T’S Don’t apply irritants viz. soil, chillies, oil etc. Don’t cauterize Don’t touch the wound with bare hands TT prophylaxis as per requirement
- 17. Passive Immunization IMPORTANCE OFRIG INFILTRATION • The anti-rabies serum/Rabies Immunoglobulin (RIG) provides passive immunity in the form of ready-made anti-rabies antibodies, before it is physiologically possible for the victim to begin producing his/her own antibodies following anti-rabies vaccination. antibodies following anti-rabies vaccination. • So RIG must be administered to all animal bite patients with Category III bite. [Incubation period of rabies is shorter here].
- 18. Indication • All CategoryIII exposures: irrespective of the biting animal. • In immune compromised individuals: RIG should be administered in both Category II and III exposures. • RIG is administered only once, preferably within 24 hrs after exposure (on day 0 along with the first dose of ARV). ARV). • Administer even when treatment is delayed but should not be given after 7 days of start of vaccination. • In re-exposure cases (completed post exposure prophylaxis previously) RIGs are not indicated. • Immunoglobulins (RIG) are life saving.
- 19.
- 20. Dose of RIG Doseof Rabies Immunoglobulin: • ERIG : 40 IU per kg body weight of patient. The ERIG produced in India contains 300 IU per ml. • HRIG : 20 IU per kg body weight. RIG provides passive immunity: • Immediate acquisition of rabies virus-neutralizing • Immediate acquisition of rabies virus-neutralizing antibodies (RVNA). • Provides protection until active immunity begins (7- 10 days since initiation of vaccination).
- 21. Administration of RabiesImmunoglobulin • RIG is most effective when administered locally and early. • The RIG should be brought to room temperature (25°C to 30°C) before administration to the patient. • Inject RIG into all wounds (anatomically feasible). • Infiltrate as much as possible in the depth and around the wound(s). Remaining quantity, if any, to be given by deep intramuscular injection at a site distant from the vaccine injection site. • RIG must never be given intravenously.
- 22. Administration of RabiesImmunoglobulin (Cont’d) • Multiple needle pricks into the wound(s) should be avoided. Use as few entry points as possible. • Secondary infection of bite wound is no contra-indication to infiltration of immunoglobulin. • Wounds on tip of finger/toe, ear lobe or nose or around the eye can be safely injected with RIG, provided the the eye can be safely injected with RIG, provided the injection is not done with excessive pressure which can cause compression syndrome. • After injecting a small quantity of RIG into the finger/ toe/ ear lobe, rest of the dose may be injected around proximal part of the finger/ toe/ external ear as far as practicable.
- 23. Administration of RabiesImmunoglobulin (Cont’d) • For any mucosal exposure rinsing with diluted RIG can be done. • Rabies Immunoglobulin should never be administered with the same syringe or at the same anatomical site as vaccine. anatomical site as vaccine. • Patient should be kept under observation for at least half-an-hour after administration of ERIG.
- 24. RIG Treatment inChildren Animal bite wounds can be severe and multiple, especially in small children. • In such cases, the calculated dose of the rabies immunoglobulin may not be sufficient to infiltrate all wounds. • Dilute the calculated volume of RIG in sterile normal saline to a volume sufficient to infiltrate all the wounds. • The total recommended dose of RIG may not preferably be exceeded as it may suppress the antibody production stimulated by the anti-rabies vaccine.
- 25. Skin Test NotRequired • There is no rationale of performing a skin test before RIG administration. • Skin Test does not reliably predict reaction. • Presently available ERIGs are highly purified and the occurrence of adverse events has been significantly reduced. So anaphylactic reactions are extremely rare.
- 26. In Case ofAny Side Effect by RIG Infiltration Although anaphylactic reactions are extremely rare, still the Anti-Rabies Centre must take following measures as preparedness for any adverse condition: • Physicians administering ERIG should always be ready to treat anaphylactic reactions with adrenalin. • The dose is 0.5 ml of 0.1 percent solution (1 in 1000, • The dose is 0.5 ml of 0.1 percent solution (1 in 1000, 1mg/ml) for adults and 0.01ml/kg body weight for children by SC or IM route. • Other emergency drugs and supportive therapy should also be available. Shelf-life of inj adrenalin is short. Note the expiry date of inj adrenalin and replenish before expiry or stock-out
- 27. Table1: Currently availableequine rabies immunoglobulin in India Brand Product Pharmaceutical 1. Anti-Rabies Serum (ARS) Purified equine RIGs, 5 ml vial (300 IU/ml, 1500 IU potency) Central Research Institute, Kasauli, Himachal Pradesh 2. Equirab Purified Equine RIGs, 5ml vial Bharat Serums and 2. Equirab Purified Equine RIGs, 5ml vial (300 IU/ml, 1500 IU potency) Bharat Serums and Vaccines Limited, Mumbai 3. Vinrig Purified Equine RIGs, 5ml vial (300 IU/ml, 1500 IU potency) VINS Biopharma, Hyderabad. 4. Abhayrig Purified Equine RIGs, 5 ml vial (300 IU/ml, 1500 IU potency) Human Biologicals Institute, Hyderabad
- 28. Table 2: Currentlyavailable human rabies immunoglobulin in India Brand Product Pharmaceuticals 1. Berirab-P Human Rabies Immunoglobulin, 150IU/ml; 2 ml (300 IU) ampoule and 5 ml (750 IU) ampoule ZLB Behring AG,Marburg, Germany/Bharat Serums and Vaccines Ltd., Mumbai. 2. Imogamrab Human Rabies Immunoglobulin, 150IU/ml; 2 ml (300 IU) ampoule and 5 ml (750 IU) ampoule Sanofi Pasteur, France 3. Kamrab Human Rabies Immunoglobulin, 150 IU/ml; 2 ml (300 IU) vial and 5 ml (750 IU) vial Kamada Ltd.,Beit-Kama, Israel /Synergy Diagnostics Pvt. Ltd.,Thane,Maharashtra
- 29. Good Bye toNervous Tissue Vaccine • Annual production 35-40 million ml • Utilized to immunize 450,000 people/annum • Efficacy 90 – 95% • Neuroparalytic accidents : 1:4000 – 1:11000 • Production stopped since December 2004
- 30. Currently available anti-rabiesvaccines in India# Brand Product Pharmaceutical 1. Abhayrab Purified Vero cell Rabies Vaccines (PVRV) Human Biologicals Institute, Hyderabad 2. Indirab Chromatographically purified (PVRV) Bharat Biotech International Ltd, Hyderabad 3. PVRV* Purified Vero cell Rabies Vaccine (PVRV) Pasteur Institute of India, Coonoor, Tamilnadu 4. Rabipur Purified Chick Embryo Cell Vaccine (PCECV) Novartis Vaccines, Mumbai (PCECV) 5 Rabivax Human Diploid Cell Culture Vaccine (HDCV) (Liquid) Serum Institute of India, Pune 6 Vaxirab Purified Duck Embryo Vaccine (PDEV) Zydus Health Care ltd., Ahmedabad 7 Vaxirab-N Purified Chick Embryo Cell Vaccine (PCECV) Zydus Health Care Ltd, Ahmedabad 8. Verorab Purified Vero cell Rabies Vaccines (PVRV) Sanofi Pasteur/ Zuventus Health Care, Mumbai * Limited production, since July 2001. # A few other vaccines are being used in the country in limited quantities
- 31. Routes of Administrationof Anti-rabies Vaccines Intramuscular Intradermal
- 32. Site of Inoculation •Deltoid muscle Or • Anterolateral part of thigh • Not recommended in gluteal region due to poor absorption
- 33. Standard intramuscular regimen. Onedose into deltoid on each of days: Essen intramuscular Regimen Post Exposure Vaccination Schedule days: 5 vials 5 visits day 0 3 7 14 28 Rabies immunoglobulin
- 34. Intra Dermal Regimens forPost Exposure Prophylaxis Cost effective. Viable alternative to replace Nerve Tissue Vaccine in India. Nerve Tissue Vaccine in India. Studies in India confirm safety efficacy and feasibility. Notified by DCGI for use in India. (February 2006)
- 35. Intra Dermal Regimens 2site regimen (Updated Thai regimen) Dose : 0.1 ml (PVRV, HDCV, PCEC) Site : Upper arm over each Deltoid Schedule : 2- 2- 2- 0- 2 8 site regimen (Oxford Regimen) (to be used only with PCEC or HDCV) Dose : 0.1 ml Schedule : 8-0-4-0-1-1 Schedule : 2- 2- 2- 0- 2 Day 0 - 2 sites Day 3 - 2 sites Day 7 - 2 sites Day 14 - No Dose Day 28 2 sites Day 0 - 8 sites Day 3 - No Dose Day 7 - 4 sites Day 14 - No Dose Day 28 - 1 site Day 90 - 1 site
- 36. ID Regimen approvedin India 2 site regimen (Updated Thai regimen) Dose: 0.1 ml Site : Upper arm over each Deltoid/ antero lateral aspect of thigh Schedule : 2- 2- 2- 0- 2 Day 0 - 2 sites Day 3 - 2 sites Day 7 - 2 sites Day 14 - No Dose Day 28 - 2 sites
- 37. General guidelines foruse of IDRV General guidelines for use of IDRV Vaccines approved by DCG (I) should be used Intradermal injections must be administered by staff trained in this technique Rabies vaccines formulated with an adjuvant should not be administered intra-dermally Vaccine when given intra-dermally should raise a visible and palpable bleb in the skin In the event that the dose is inadvertently given subcutaneously or intra- muscularly or in the event of spillage, a new dose should be given intradermally in near by site Animal bite victims on chloroquine therapy (anti-malarial therapy) and immunosuppressed should be given ARV by intramuscular route.
- 38. Vaccines approved forID use in India PVRV – Verorab, Aventis Pasteur (Sanofi Pasteur) India PCECV – Rabipur, Chiron Behring Vaccines Pvt. Ltd. PCECV – Vaxirab N, Zydus Cadila PVRV – Pasteur Institute of India, Coonoor PVRV – Abhayrab, Human Biologicals Institute PVRV- Indirab, Bharat biotech Only the anti-rabies vaccines approved by DCGI for ID administration should be used for ID route.
- 39. Potency & Volumeof approved vaccines Stated potency of > 2.5 IU per IM dose, irrespective of the re-constituted volume. The same vaccine is used for ID administration The same vaccine is used for ID administration as per stated schedule 0.1 ml of vaccine, irrespective of reconstituted volume is administered per ID site.
- 40. Materials required Vialof approved rabies vaccine 2 ml disposable syringe with 24 G needle for reconstitution of vaccine Disposable 1 ml syringe with graduations with a fixed 28 G needle Disinfectant swabs for cleaning the top of the vial and the patient’s skin
- 41. Maintenance of vaccinevial in use Use aseptic technique to withdraw the dose Store in a refrigerator at 20C to 80C Reconstituted vaccines should be used as soon Reconstituted vaccines should be used as soon as possible or within 6 to 8 hours if kept at 20C to 80C. All unused reconstituted vaccine at the end of 6- 8 hours must be discarded.
- 42. Correct technique for IDinjection
- 43. Anti-Rabies treatment Centresusing ID route • Trained staff to give anti-rabies vaccination by ID route. • Cold chain facilities for vaccine storage and • Cold chain facilities for vaccine storage and supply of syringes and needles. • Are well versed in management of open vial and safe storage practices.
- 44. Post Exposure Prophylaxis Pointsto remember Day 0 (D0) - Day of 1st dose of vaccine given, not the day of bite. All modern Tissue Culture Vaccines (TCVs) are equally effective and safe. Never inject the vaccines into the gluteal region. Interchange of vaccines acceptable in special circumstances but not to be done routinely. Reconstituted vaccine to be used immediately. Vaccine dosage is same for all age groups.
- 45. Medical advice toVaccinee No dietary restriction. No restriction of physical exercise. Avoid immune suppressants (Steroids, anti-malarials) if possible. possible. Best to avoid consumption of alcohol during the course of treatment. Complete the course of vaccination.
- 46. Management of Re-exposure Reexposure after a full course (Pre/Post-exposure) I/M or I/D irrespective of Category of exposure or Time since previous vaccination 2 boosters (Day 0 & Day 3) No RIG 2 boosters (Day 0 & Day 3) No RIG All incomplete/partial vaccinations - Treat as fresh case Re-exposure following PEP with NTV As fresh case Treatment as per merits of the case
- 47. Pre-Exposure Prophylaxis (PEP) Recommendedfor risk groups like Veterinarians, Laboratory personnel working with rabies virus, medical and Paramedical personnel treating Rabies patients. Rabies patients. Dog catchers/Dog pound workers, Forest staff, Zoo keepers. Postmen, Policemen, Courier Boys, School Children in endemic countries.
- 48. 3-dose series intramuscular(1ml/0.5ml) or intradermal regimen(0.1ml) Pre-exposure Pre-exposure Prophylaxis Exposure: No Rabies immunoglobulin needed day 0 7 28 day 0 3