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Anti-rabies immunoglobulin

Liquid anti-rabies immunoglobulin from horse serum

Immunoglobulinum antirabicum ex sero eqvi fluidum
Liquid anti-rabies immunoglobulin from horse serum is a protein fraction of immune horse serum, isolated by rivanol-alcohol method.
The titer of the specific anti-rabies antibodies is no less then 150 IU/ml.
Stabilizer glycocol.
The substance is a transparent or somewhat opalescent liquid, colorless or slightly yellow. Pink color of the substance is not allowed.
IMMUNOLOGICAL FEATURES
The anti-rabies immunoglobulin is able to neutralize the rabies virus both in vitro and in vivo.
PURPOSE
The immunoglobulin is to be used in combination with the anti-rabies vaccine for prevention of hydrophobia in humans after being bitten by rabid or suspect for Rabies animals.
DIRECTIONS FOR USE AND DOSAGE
Local treatment of the wound should be done immediately or as soon as possible after the bite or damage. The wound is rinsed with soapy water or detergent solution and pre-treated with 40-70% alcohol or 5% iodine solution.
After the local pre-treatment of the wound the specific treatment begins. The immunoglobulin is most effective when administered within one day after the trauma. Before use all ampoules should be checked for being intact and having labels. The substance from damaged ampoules, ampoules lacking the labels, as well as the substance with altered physical or chemical properties (color, transparency, etc.), expired substance or the one that was stored improperly must not be used.
Breaking the ampoules and inoculation of the preparation should be done under strict aseptic and antiseptic rules.
Anti-rabies immunoglobulin is injected in a dose of 40 IU per 1 kg of body weight of an adult or child patient. For example, the body weight is 60 kg, the immunoglobulin activity (as indicated on the label) is 200 IU in 1 ml. To calculate the required dose the patient weight (60 kg) should be multiplied by 40 IU and divided by the preparation activity:
60 x 40 : 200 = 12 ml.
Before injection of the anti-rabies immunoglobulin the patient’s sensitivity to heterogeneous protein should be tested by intra-skin inoculation of the diluted 1:100 immunoglobulin. The ampoules with the diluted immunoglobulin are marked red and are added to every package with non-diluted (blue label) immunoglobulin.
0.1 ml of the diluted 1:100 immunoglobulin is being inoculated into the skin of internal surface of the lower arm.
The test is considered negative if after 20-30 minutes the redness or swelling in the inoculation point is less then 1 cm. The test is considered positive if in 20-30 minutes after inoculation the swelling or redness is 1 cm or more.
If the reaction is negative, another 0.7 ml of diluted immunoglobulin is inoculated under the skin of the upper arm. If there is no reaction after 30 minutes, then all calculated dose of non-diluted immunoglobulin is injected in three shots with 10-15 minute intervals. The immunoglobulin should be warmed up to 37 degrees, and should be taken from a fresh ampoule for every shot.
The calculated dose of the immunoglobulin should be infiltrated around and inside the wound. If the anatomical location of the wound does not permit inoculation of the whole dose around the wound, the remaining immunoglobulin should be injected intramuscularly into another place (such as buttocks, thighs, or lower arm). The whole dose of the anti-rabies immunoglobulin is injected in 1 hour. If the intra-skin test was positive (redness or swelling more then 1 cm) or if an allergic reaction to the subcutaneous injection appears, the immunoglobulin should be administered extremely carefully. First, the diluted immunoglobulin is inoculated under the skin of the upper arm every 15-20 minutes in the doses of 0.5 ml, then 2 ml and 5 ml. Then follows 0.1 ml of the non-diluted immunoglobulin, and after that, in 30-60 minutes the remaining non-diluted immunoglobulin is injected in three shots with 15-20 minutes intervals. The immunoglobulin should be warmed up to 37 degrees C. It is recommended to administer antihistamin preparations such as Suprastin or Dimedrol before the first shot. To prevent anaphylactic shock subcutaneous injection of 0.1% adrenalin solution or 5% ephedrine solution in age-appropriate dosage is also recommended.
When the anti-rabies immunoglobulin is inoculated, the solutions of Adrenalin, Ephedrine, Dimedrol or Suprastin should be always at hand.
To prevent complications of allergic origin after inoculation of the immunoglobulin oral antihistamin agents such as Suprastin, Dimedrol, Diprazin, or Fenkarol should be prescribed in an age-appropriate dosage 2 times a day for 7 to 10 days..
If the patient has received an anti-tetanus serum during the last 24 hours, the anti-rabies immunoglobulin can be inoculated without prior intra-skin testing. After injection of the anti-rabies immunoglobulin the patient should stay under medical observation for at least 1 hour. The immunization is to be recorded in the standard registration forms containing date, manufacturer of the preparation, number of the batch, and the patient’s reaction to the injection.
REACTION TO INOCULATION
The inoculation of the anti-rabies immunoglobulin may be accompanied by an allergic reaction, including anaphylactic shock and serum sickness.
CONTRAINDICATIONS
There is no contraindications. If the patient displays acute reaction to the inoculation of the anti-rabies immunoglobulin, or if the patient has a history of heavy allergic reactions to anti-tetanus serum or any other horse serum derivatives, then the anti-rabies immunoglobulin should be administered in a hospital having reanimation equipment.
PRODUCTION FORM
Anti-rabies immunoglobulin is produced in 5 or 10 ml ampoules marked blue. Diluted 1:100 for sensitivity testing is produced in 1 ml ampoules, marked red. Every set includes 1 ampoule of non-diluted immunoglobulin and 1 ampoule of diluted one.
PACKAGE
Every 5 sets are packed in a cardboard package together with the instruction for use and an ampoule cutter.
STORAGE CONDITIONS AND TRANSPORTATION
The medicine is to be stored in a closed dry room at about 5 degrees. The preparation is to be shipped by any covered transport under the conditions that exclude freezing and heating the preparation beyond 20 degrees.
SHELF LIFE 2 years.