HYPERRAB S/D RABIES IMMUNE GLOBULIN (HUMAN) 150 [iU]/mL Injection

INDICATIONS AND USAGE Rabies vaccine and Hyper RAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. Hyper RAB S/D should be administered as promptly as possible after exposure, but can be administered up to the eighth day after the first dose of vaccine is given. Recommendations for use of passive and active immunization after exposure to an animal suspected of having rabies have been detailed by the U.S.

Public Health Service Advisory Committee on Immunization Practices (ACIP). (19) Every exposure to possible rabies infection must be individually evaluated. The following factors should be considered before specific antirabies treatment is initiated: 1.

Species of Biting Animal Carnivorous wild animals (especially skunks, foxes, coyotes, raccoons, and bobcats) and bats are the animals most commonly infected with rabies and have caused most of the indigenous cases of human rabies in the United States since 1960. (20) Unless the animal is tested and shown not to be rabid, postexposure prophylaxis should be initiated upon bite or nonbite exposure to these animals (see item 3 below). If treatment has been initiated and subsequent testing in a competent laboratory shows the exposing animal is not rabid, treatment can be discontinued.

In the United States, the likelihood that a domestic dog or cat is infected with rabies varies from region to region; hence, the need for postexposure prophylaxis also varies. However, in most of Asia and all of Africa and Latin America, the dog remains the major source of human exposure; exposures to dogs in such countries represent a special threat. Travelers to those countries should be aware that >50% of the rabies cases among humans in the United States result from exposure to dogs outside the United States.

Rodents (such as squirrels, hamsters, guinea pigs, gerbils, chipmunks, rats, and mice) and lagomorphs (including rabbits and hares) are rarely found to be infected with rabies and have not been known to cause human rabies in the United States. However, from 1971 through 1988, woodchucks accounted for 70% of the 179 cases of rabies among rodents reported to CDC. (21) In these cases, the state or local health department should be consulted before a decision is made to initiate post exposure antirabies prophylaxis.

2. Circumstances of Biting Incident An unprovoked attack is more likely to mean that the animal is rabid. (Bites during attempts to feed or handle an apparently healthy animal may generally be regarded as provoked.) 3.

Type of Exposure Rabies is transmitted only when the virus is introduced into open cuts or wounds in skin or mucous membranes. If there has been no exposure (as described in this section), postexposure treatment is not necessary. Thus, the likelihood that rabies infection will result from exposure to a rabid animal varies with the nature and extent of the exposure.

Two categories of exposure should be considered: Bite: any penetration of the skin by teeth. Bites to the face and hands carry the highest risk, but the site of the bite should not influence the decision to begin treatment. (22) Bat-associated strains of rabies can be transmitted to humans either directly through a bat's bite or indirectly through the bite of an animal previously infected by a bat.

Because some bat bites may be less severe, and can go completely undetected, unlike bites inflicted by larger animals, especially mammalian carnivores, rabies postexposure treatment should be considered for any physical contact with bats when bite or mucous membrane contact cannot be excluded. (23) Nonbite: scratches, abrasions, open wounds or mucous membranes contaminated with saliva or any potentially infectious material, such as brain tissue, from a rabid animal constitute nonbite exposures. If the material containing the virus is dry…

DOSAGE AND ADMINISTRATION The recommended dose for Hyper RAB S/D is 20 IU/kg (0.133 mL/kg) of body weight given preferably at the time of the first vaccine dose. (8,9) It may also be given through the seventh day after the first dose of vaccine is given. If anatomically feasible, up to the full dose of Hyper RAB S/D should be thoroughly infiltrated in the area around the wound and the rest should be administered intramuscularly in the deltoid muscle of the upper arm or lateral thigh muscle.

The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve. (26) Hyper RAB S/D should never be administered in the same syringe or needle or in the same anatomical site as vaccine. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Rabies postexposure prophylaxis schedule—United States, 1999 19 Vaccination status Treatment Regimen These regimens are applicable for all age groups, including children. HDCV=human diploid cell vaccine; PCEC=purified chick embryo cell vaccine; RIG=rabies immune globulin; RVA=rabies vaccine adsorbed; IM, intramuscular Not previously vaccinated Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water. If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds.

RIG Administer 20 IU/kg body weight. If anatomically feasible, the full dose should be infiltrated around the wound(s) and any remaining volume should be administered IM at an anatomical site distant from vaccine administration. Also, RIG should not be administered in the same syringe as vaccine.

Because RIG might partially suppress active production of antibody, no more than the recommended dose should be given. Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area The deltoid area is the only acceptable site of vaccination for adults and older children. For younger children, the outer aspect of the thigh may be used.

Vaccine should never be administered in the gluteal area. ), one each on days 0 Day 0 is the day the first dose of vaccine is administered. , 3, 7, 14, and 28. Previously vaccinated Any person with a history of preexposure vaccination with HDCV, RVA, or PCEC; prior postexposure prophylaxis with HDCV, RVA, or PCEC; or previous vaccination with any other type of rabies vaccine and a documented history of antibody response to the prior vaccination. Wound cleansing All postexposure treatment should begin with immediate thorough cleansing of all wounds with soap and water.

If available, a virucidal agent such as a povidone-iodine solution should be used to irrigate the wounds. RIG RIG should not be administered. Vaccine HDCV, RVA, or PCEC 1.0 mL, IM (deltoid area ), one each on days 0 and 3.