Active substanceAntimicrobial immunoglobulinAntimicrobial immunoglobulin
Dosage form: & nbspinjection
Composition:

1 ml of the preparation contains:

Active ingredient: specific antibodies - not less than 150 ME;

Excipients: sodium chloride 9 mg, glycine (glycine) 22.5 mg, water for injection up to 1 ml.

Issue complete with immunoglobulin antirabies from the blood serum of a horse diluted 1: 100.

Description:

Immunoglobulin anti-rabies - a clear or slightly opalescent liquid from colorless to slightly yellow in color.

Immunoglobulin anti-rabies diluted 1: 100 - a clear or slightly opalescent liquid from colorless to slightly yellow in color.

Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

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

Pharmacodynamics:

Immunoglobulin anti-rabies from horse blood serum is a gamma-globulin fraction of the horse's immune serum obtained by rivanol-alcohol method.

Immunoglobulin anti-rabies (AIG) has the ability to neutralize rabies virus.

Immunoglobulin anti-rabies diluted 1: 100 reveals the presence of sensitization to horse serum proteins.

Indications:

Apply in combination with an antirabic vaccine (on the same day as the first dose of rabies vaccine) to prevent human disease hydrophobia with severe bites furious or suspicious of rabies animals.

Contraindications:

There are no contraindications.

With a positive sample for intradermal the introduction of immunoglobulin antirabies diluted 1: 100, as well as in the presence of a history of the affected severe allergic reactions to the introduction of tetanus antitetanus or other preparations of horse serum, the introduction of rabies immunoglobulin is recommended in a hospital provided with resuscitation facilities.

Pregnancy and lactation:Pregnancy and infancy are not contraindications for emergency immunization under any circumstances.
Dosing and Administration:

Immediately or as early as possible after a bite or injury, local wound treatment: the wound surface is abundantly washed with water with soap (or detergent), and the edges of the wound are treated with 70% alcohol or 5% alcoholic iodine solution.

Immediate suturing of the wound is contraindicated; if necessary, a simple connection of its edges is permissible. The application of sutures is shown exclusively in the following cases: with extensive wounds - several leading skin seams after pre-treatment of the wound; on cosmetic indications (imposition cutaneous sutures on the wounds of the face); stitching of bleeding vessels to stop external bleeding.

After the local processing wounds immediately begin treatment and prophylactic immunization. AIG should be administered no later than three days after a 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 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.

AIG should be administered exclusively in combination with an antirabic vaccine, the first administration of which is performed no more than 30 min after the administration of AIG in a dose of 1 ml. The scheme of treatment of AIG and an anti-rabies vaccine is indicated in Table 1.

Table 1. Scheme of treatment-and-prophylactic vaccinations with anti-rabies vaccine (AB) and rabies immunoglobulin (AIG)

Category

damages

Nature of contact

Data on the animal

Treatment

1

There are no damages to the skin, there are no discomforts of the skin and mucous membranes.

She is sick with rabies.

Not

appointed.

2

Inflammation of intact skin, abrasions, scratches, single superficial bites of the trunk, upper and lower extremities (except bites of dangerous localization: head, face, neck, hand, fingers and toes) caused by domestic and farm animals

If, within 10 days of monitoring the animal, it remains healthy, then the treatment is terminated (i.e. after the 3rd injection).

If laboratory evidence of the absence of rabies in an animal, the treatment is discontinued from the moment establishing the absence of rabies.

In all other cases, when it is impossible to observe the animal for 10 days (killed, killed, run away, etc.), continue treatment according to the indicated scheme.

Start treatment immediately:

AB on 1,0 ml at 0, 3, 7, 14, 30, 90 day.

3

Any mucus membranes, any bites of the head, face, neck, hand, fingers and toes, genitals; single or multiple deep ragged wounds inflicted by domestic and farm animals.

Any damnation and damage caused by wild carnivorous animals, bats and rodents.

If it is possible to observe the animal, and it remains healthy for 10 days, the treatment is stopped (i.e. after the 3rd injection).

If laboratory evidence of the absence of rabies in an animal, the treatment is discontinued from the moment establishing the absence of rabies.

In all other cases, when it is impossible to observe the animal, continue treatment according to the indicated scheme.

Initiate immediate combined treatment with an antirabies immunoglobulin: AIG on day 0 and an antirabic vaccine: AB at 1.0 ml at 0, 3, 7, 14, 30 and 90 days.

AIG injected at a dose of 40 IU per 1 kg of body weight of an adult or child. Scope injected AIG should not exceed 20 ml.

Example: body weight of the victim 60 kg; activity of AIG (indicated on ampoules and packs with the drug), for example, 200 IU per ml. In order to determine (60 kg) multiply by 40 ME and divide the obtained number by the activity of the drug (200 ME), that is:

60x40 / 200 = 12 ml

Before the introduction of AIG to detect sensitivity to a foreign protein, an intradermal test with an immunoglobulin, an antirabic diluted 1: 100 (ampoules marked in red), which is in a box with an undiluted preparation (ampoules marked in blue), is mandatory.

The diluted 1: 100 immunoglobulin is administered in a volume of 0.1 ml intradermally to the flexor surface of the forearm.

The sample is considered negative if after 20-30 minutes there is no swelling or redness at the injection site or 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 anti-rabies diluted 1: 100 immunoglobulin is injected subcutaneously into the shoulder region. If no reaction occurs after 30 minutes, the entire calculated dose of AIG heated to 37 ± 0.5 ° C is injected fractionally in 3 divided doses at intervals of 10-15 minutes, taking the preparation for each portion from unopened vials.

The calculated dose of AIG 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 introduced around the wounds, the rest of AIG is administered intramuscularly to a site other than the introduction of the vaccine (buttock muscles, upper outer thigh, shoulder).

The introduction of AIG and an anti-rabies vaccine should not be carried out on the same shoulder.

The entire dose of AIG is administered within one hour.

The most effective administration of the drug in the first day after the injury, but no later than three days.

With a positive intradermal test (swelling or redness of 1 cm or more) or in case of an allergic reaction to a subcutaneous injection of AIG are administered with special precautions. First, it is recommended to introduce an immunoglobulin diluted 1: 100 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 minutes,then inject 0.1 ml of undiluted immunoglobulin and after 30-60 minutes intramuscularly administered the entire prescribed dose of the drug heated to 37 ± 0.5 ° C, divided into 3 divided doses at intervals of 10-15 minutes.

Before the first injection, parenteral administration of antihistamines (suprastin, dimedrol, etc.) is recommended. In order to prevent shock at the same time as the introduction of AIG, subcutaneous administration of a 0.1% solution of epinephrine or a 5% solution of ephedrine at age dosage is recommended:

When you introduce AIG, you should always have ready-made solutions of epinephrine, ephedrine, dimedrol or suprastin.

After the introduction of AIG, the patient should be under medical supervision for at least 1 hour. The first vaccination with an anti-rabies vaccine is carried out on the day of introduction of AIG after administration of the latter. 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:

The introduction of AIG can be accompanied by the development of allergic reactions, including including anaphylactic shock and serum sickness, in connection with which the place of vaccination should be equipped with anti-shock therapy.

Interaction:

Possible introduction in one day with emergency preventiontetanus, with AIG injected in front of the tetanus antiserum.

Compatible with antibiotics.

The use of immunosuppressive drugs during the subsequent course of vaccination is acceptable for life.

Special instructions:

The drug should not be administered after the start of the course of administration rabies vaccine.

When hypersensitivity to heterologous immunoglobulins and sera (in the anamnesis) should be administered orally antihistamines in the age-related dosage 2 times a day for 7-10 days (with careful monitoring of the patient).

Intravenous introduction of AIG is contraindicated (because of the risk of developing shock), so when injecting it is necessary to make sure that the needle has not penetrated into the blood vessel.

To avoid possible interactions between several different drugs, it is necessary to inform the doctor about any other ongoing therapy.

The patient, who has received anti-tetanus serum for the previous 24 hours, for any reason, AIG is administered without preliminary setting of the intradermal test.

Effect on the ability to drive transp. cf. and fur:Does not affect.
Form release / dosage:Injection, 150 IU / ml.
Packaging:

Antimicrobial immunoglobulin - 3 ml, 5 ml or 10 ml in the ampoule.

Immunoglobulin anti-rabies diluted 1: 100 - 1 ml in the ampoule.

Issued in the kit: 1 ampoule of immunoglobulin and 1 ampoule immunoglobulin diluted 1: 100.

For 5 sets are packed in a pack of cardboard box for consumer packaging. In the pack insert instruction for use and knife ampoule or knife ampoule ceramic.

Storage conditions:

Storage - at a temperature of 2 to 8 ° C out of the reach of children. Do not freeze.

Transportation - at a temperature of 2 to 8 ° C. Do not freeze.

Shelf life:

2 years.

The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:For hospitals
Registration number:П N016002 / 01
Date of registration:28.09.2009 / 15.08.2017
Expiration Date:Unlimited
The owner of the registration certificate:FARM STANDART, OJSC FARM STANDART, OJSC Russia
Manufacturer: & nbsp
Representation: & nbspPHARMSTANDART JSC PHARMSTANDART JSC Russia
Information update date: & nbsp24.10.2017
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