Active substanceAntimicrobial immunoglobulinAntimicrobial immunoglobulin
Dosage form: & nbspinjection
Composition:

Immunoglobulin anti-rabies from horse blood serum is a gamma-globulin fraction of the horse's immune serum obtained by rivanol-alcohol method. The activity of the drug is not less than 150 IU / ml.

Stabilizer - glycine (glycine) - at a concentration of (2.25 ± 0.25)%.

Description:

Antimicrobial immunoglobulin - a clear or slightly opalescent liquid, from colorless to slightly yellow in color.

Immunoglobulin diluted 1: 100 - Clear, colorless liquid.

Pharmacotherapeutic group:MIBP globulin
ATX: & nbsp

J.06.B.B.05   Immunoglobulin human anti-rabies

Pharmacodynamics:

Immunoglobulin anti-rabies has the ability to neutralize rabies virus.

Indications:

They are used in combination with rabies vaccine to prevent people from suffering from hydrophobia in severe bites by rabid animals suspected of rabies.

Contraindications:

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 history of severe allergic reactions to the administration of tetanus antitetanus or other preparations of horse serum, it is recommended to administer rabies immunoglobulin in a hospital provided with resuscitation facilities.

Dosing and Administration:
Local treatment of wounds (bites, scratches, abrasions) and places of mourning should begin immediately or as soon as possible after a bite or injury. It consists in extensive washing for a few minutes (up to 15 minutes) of the wound surface with water with soap or other detergent (detergent) or in the absence of soap or detergent, the place of damage is washed with a jet of water.After that, the edges of the wound should be treated with 70% ethyl alcohol or 5% aqueous-alcoholic iodine solution. If possible, sutures should be avoided.

Sealing is shown only in the following cases:

- with extensive wounds - several leading skin seams after pre-treatment of the wound;

- on cosmetic indications (imposition of cutaneous sutures on the wounds of the face);

- stitching of bleeding vessels to stop external bleeding.

In the presence of indications for the use of anti-rabies immunoglobulin it is used immediately before the application of sutures.

After local treatment, the wounds immediately begin treatment and preventive immunization. Antimicrobial immunoglobulin must be administered no later than three days after bite or damage to a rabid or suspicious rabies animal. The most effective administration of the drug in the first day after the injury.

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 changing its physical properties (color, transparency, etc.), expired shelf life and improper storage.

Opening of ampoules and the procedure for administering the drug are carried out with strict adherence to aseptic and antiseptic rules.

In the provision of anti-rabies care, immunoglobulin is first administered and, no more than 30 minutes after it, an antirabic vaccine is administered. Antibacterial immunoglobulin (ampoules labeled with a blue text) is administered at a dose of 40 ME per 1 kg of body weight of an adult or a child. The whole dose of anti-rabies immunoglobulin is administered for one hour. The volume of heterologous anti-rabies immunoglobulin administered should not exceed 20 ml.

Example: body weight of the victim - 60 kg; activity of immunoglobulin (indicated on the package label) - 200 IU / ml. In order to determine the dose of immunoglobulin necessary for administration, the body weight of the victim (60 kg) should be multiplied by 40 ME and divide the obtained number by the activity of the preparation (200 ME), i.e

60x40/200=12 ml

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 deeply intramuscularly into a site other than the introduction of the rabies vaccine.With the intramuscular route of administration of the immunoglobulin, the administration of the drug into the muscles of the buttock, the outer part of the thigh is assumed.

Before the introduction of anti-rabies immunoglobulin to detect sensitivity to a foreign protein, an intradermal test with a diluted 1: 100 immunoglobulin is mandatory (the ampoules are labeled with red text).

The diluted immunoglobulin is administered in 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 immunoglobulin diluted 1: 100 is injected subcutaneously. If there is no reaction after 30 minutes, the entire calculated dose of immunoglobulin, heated to (37 ± 0.5) ° C, is injected in 3 divided doses in 3 divided doses at intervals of 10-15 minutes, collecting the preparation for each portion from unopened vials.

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.

When administering anti-rabies immunoglobulin, solutions of epinephrine, ephedrine, dimedrol or suprastin should always be available.

First, it is recommended to introduce a diluted 1: 100 drug in the subcutaneous tissue of the shoulder in doses of 0.5 ml, 2.0 ml, 5.0 ml with an interval of 15-20 min, then 0.1 ml of undiluted immunoglobulin. After 30-60 minutes, the entire prescribed dose of the drug heated to (37 ± 0.5) ° C, infiltrated around the wound or injected intramuscularly (depending on the nature of the lesion) divided into 3 divided doses at intervals 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 a solution of epinephrine or norepinephrine at age dosage and 0.2-1.0 ml of ephedrine 5%.

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.

If necessary, emergency prophylaxis of tetanus is carried out after the introduction of immunoglobulin anti-rabies and the firstinjection of rabies vaccine. The patient, who received antitetanus serum within the next 24 hours, anti-rabies immunoglobulin is administered without first setting 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.

Side effects:

Injections of anti-rabies immunoglobulin may be accompanied by the development of allergic reactions, including anaphylactic shock and serum sickness.

Interaction:

Interaction with other drugs has not been established.

Form release / dosage:Injection, 150 IU / ml.
Packaging:

Antimicrobial immunoglobulin - 5 and 10 ml in the ampoule; immunoglobulin diluted 1: 100 - 1 ml in the ampoule.

Issued in the kit: 1 ampoule of immunoglobulin and 1 ampoule of immunoglobulin diluted 1: 100. 5 sets - in a cardboard bundle. The package contains instructions for use and an ampoule knife.

In the case of ampoules with opening systems (color fracture ring or notch and color point), the attachment of the ampoule knife is not provided.

Storage conditions:

Storage - in accordance with SP 3.3.2.1248-03, out of the reach of children at a temperature of 2 to 8 FROM.

Transportation - in accordance with SP 3.3.2.1248-03, all types of covered transport at a temperature of 2 to 8 ° C.

Shelf life:1 year 6 months. After the expiration date the drug is not to be used.
Terms of leave from pharmacies:For hospitals
Registration number:P N002639 / 01
Date of registration:23.07.2008 / 09.02.2016
Expiration Date:Unlimited
The owner of the registration certificate:MICROB Russian Research Anti-Plague Institute Rospotrebnadzor FKUZMICROB Russian Research Anti-Plague Institute Rospotrebnadzor FKUZ Russia
Manufacturer: & nbsp
Information update date: & nbsp24.10.2017
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