TRCS ERIG

TRCS ERIG

Manufacturer:

The Thai Red Cross Society

Distributor:

Biovalys

Marketer:

Biovalys
Full Prescribing Info
Contents
Purified equine antirabies serum.
Description
Each vial contains purified equine antirabies serum 200 IU, amino acetic acid (glycine) 10 mg, sodium chloride 260-400 mOsmol/kg, carbolic acid (phenol) not more than 2.5 mg.
Indications/Uses
Prevention of rabies in patients at risk of being exposed to rabies after contact with a rabid animal or an animal presumed rabid.
Antirabies serum alone could not be sufficient for treatment and should always be combined with rabies vaccination.
Dosage/Direction for Use
40 IU/kg body weight in all patients, children and adult.
Antirabies serum should be injected as soon as possible after exposure. If anatomically feasible, as much as possible of the dose should be infiltrated around the wounds. The remainder should be administered IM (into the gluteal region) in a single dose.
In no cases should the dosage of the rabies immunoglobulin be exceeded because immunoglobulins may partially suppress active production of antibodies.
Special Precautions
Use with extreme caution in patients with a history of allergic symptoms or hypersensitivity to horse serum. In such cases, the use of human antirabies immunoglobulin is preferable.
Since the antirabies serum is prepared from horse serum. Sensitization to heterologous protein may occur in some individuals. To avoid anaphylaxis, skin test should be performed prior to the administration by injection of 0.02 mL of 1:100 antirabies serum dilution intradermally on the volar surface of the forearm. The same dose of physiological saline solution should be used as a control. The result observed 15 min later is considered to be positive if 10-mm diameter of wheal appears and the control is negative.
A positive test result should be considered as a warning and human antirabies immunoglobulin should be used in preference. If human antirabies immunoglobulin is not available, equine antirabies serum administration should be under observation by a medical doctor.
A negative test result is not an absolute guarantee for the absence of an immediate allergic type reaction, it should be used with caution.
In case of doubt, do not hesitate to ask a physician for advice.
Use In Pregnancy & Lactation
The use of human antirabies immunoglobulin is preferable.
The safety of TRCS ERIG used during pregnancy has not been established.
Side Effects
Mainly are immediately or delayed allergic type reactions.
Immediate reactions are anaphylactoid reactions with hypotension, dyspnea, rash or urticaria.
Delayed reactions consist of inflammatory reaction, fever, rash or urticaria, adenopathy and arthralgia.
Drug Interactions
Rabies vaccine should be inoculated in a different part of the body eg, contralaterally. In this case interference is minimized.
Antirabies serum should be administered with different syringe from the vaccine.
Storage
Keep in tightly closed container and storage between 2-8°C (in a refrigerator), protect from light.
ATC Classification
J06BB05 - rabies immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
Presentation/Packing
Inj (vial) 200 IU/mL x 5 mL x 10's.
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