Composition, form of production and packaging
The injection solution is clear, slightly opalescent, colorless or slightly yellow in color.
immunoglobulin equine rabies at least 150 IU
Excipients: stabilizer - glycine.
5 ml - ampoules (1) complete with immunoglobulin diluted 1: 100 (amp 1 ml 1 piece) - kit (5) - packs of cardboard.
10 ml - ampoules (1) complete with immunoglobulin diluted 1: 100 (amp 1 ml 1 pc.) - kit (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Immunoglobulin anti-rabies from horse blood serum is a protein fraction of the horse's immune serum obtained by rivanol-alcohol method. The titer of specific virus neutralizing antibodies is not less than 150 IU / ml.
Immunoglobulin anti-rabies has the ability to neutralize rabies virus.
- in combination with an anti-rabies vaccine to prevent people from becoming infected with hydrophobia in severe bites by rabid animals suspected of rabies.
Immediately or as soon as possible after a bite or injury, local treatment of the wound is performed. Wounds are abundantly washed with water with soap (or detergent) and treated with 40-70 В° alcohol or tincture of iodine. After the local treatment of the wound, a specific treatment immediately begins. Antimicrobial immunoglobulin must be administered no later than three days after bite or damage to a rabid or suspicious rabies animal.
Before the injection, check the integrity of the ampoules and the presence of markings on them. The preparation is not suitable for use in ampoules with broken integrity, marking, as well as when changing its physical properties (color, transparency, etc.), expired, with improper storage.
Opening of ampoules and the procedure for administering the drug are carried out with strict adherence to aseptic and antiseptic rules.
An antirabic immunoglobulin is administered at a dose of 40 IU per kg of body weight of an adult or a child (simultaneous administration of the first rabies vaccine with an immunoglobulin is allowed).
Example: body weight of the victim 60 kg; the activity of the immunoglobulin (indicated on the package label), for example, 200 IU per ml. In order to determine the dose of immunoglobulin necessary for administration, the weight of the injured (60 kg) should be multiplied by 40 ME and divided the resultant number by the drug activity (200 IU), that is, 60? 40/200 = 12 ml
Before the introduction of anti-rabies immunoglobulin for detection of sensitivity to a foreign protein, an intracutaneous test with a diluted 1: 100 immunoglobulin (ampoules marked in red), which is in the box with the preparation (the ampoules are marked in blue), is mandatory.
The diluted immunoglobulin is administered at a dose of 0.1 ml intradermally to the flexor surface of the forearm.
The sample is considered negative if, after 20 minutes, swelling or redness at the injection site is less than 1 cm. The sample is considered positive if the swelling or redness reaches 1 cm or more.
If the reaction is negative, 0.7 ml of diluted immunoglobulin is injected subcutaneously. If no reaction occurs after 30 minutes, the whole calculated dose of immunoglobulin, heated to 37 В± 0.5 В° C, is injected intramuscularly in 3 divided doses at intervals of 10-15 minutes, dialing the drug for each dose from unopened vials.
The calculated dose of immunoglobulin should be infiltrated around the wounds and in the depth of the wound. If the anatomical location of the lesion (fingertips, etc.) does not allow the entire dose to be administered around the wounds, the immunoglobulin residue is injected intramuscularly into places other than the vaccine (buttock muscles, outer thigh, shoulder). The whole dose of anti-rabies immunoglobulin is administered for one hour. The most effective administration of the drug in the first day after the injury.
With a positive intradermal test (swelling or redness of 1 cm or more) or in case of an allergic reaction to a subcutaneous injection, the immunoglobulin is administered with special precautions. First, it is recommended to inject the diluted 1: 100 drug into the subcutaneous tissue of the shoulder in doses of 0.5 ml, 2.0 ml, 5.0 ml with an interval of 15-20 minutes, then 0.1 ml of undiluted immunoglobulin and after 30-60 min, intramuscularly inject the entire prescribed dose of the drug heated to 37 В± 0.5 В° РЎ, divided into 3 receptions with an interval of 10-15 minutes. Before the first injection, parenteral administration of antihistamines (suprastin, dimedrol, etc.) is recommended, and in order to prevent shock before the introduction of immunoglobulin, subcutaneous administration of 0.1% solution of epinephrine or a 5% solution of ephedrine at age dosage is recommended. The injection should be repeated before intramuscular injection of the first portion of the undiluted preparation.
When administering anti-rabies immunoglobulin, solutions of epinephrine, ephedrine, dimedrol or suprastin should always be available.
To prevent complications of the allergic nature after the administration of immunoglobulin, it is necessary to prescribe oral antihistamines (suprastin, dimedrol, diprasyl, fenkarol, etc.) at an age dosage 2 times a day for 7-10 days.
The patient who received anti-tetanus serum within the next 24 hours, the anti-rabies immunoglobulin is administered without preliminary preparation of the intradermal test. After the introduction of an immunoglobulin anti-rabies patient should be under medical supervision for at least 1 hour. The vaccine is recorded in the prescribed registration forms with the indication of the dose, the date, the manufacturer of the drug, the number of the series, the response to the introduction.
Injections of anti-rabies immunoglobulin may be accompanied by the development of allergic reactions, including anaphylactic shock and serum sickness.
There are no contraindications.
With a positive reaction to the introduction of diluted 1: 100 immunoglobulin anti-rabies, and also in the presence of a severe severe allergic reaction to the administration of tetanus antitetanus or other preparations of horse serum in the anamnesis, it is recommended to administer rabies immunoglobulin in a hospital provided with resuscitation facilities.
Interaction with other drugs has not been established.
TERMS OF RELEASE FROM PHARMACY
For treatment and preventive and sanitary facilities.
TERMS AND CONDITIONS OF STORAGE
Storage - in accordance with SP 22.214.171.1248-03, in closed, dry, dark rooms at a temperature of 2 В° to 8 В° C.
Transportation - in accordance with SP 126.96.36.1998-03, all types of covered transport at a temperature of 2 В° to 20 В° C. Freezing is not allowed.
Shelf life - 1 year 6 months.