Active substanceAntimicrobial immunoglobulinAntimicrobial immunoglobulin
Dosage form: & nbspsolution for intramuscular and subcutaneous administration
Composition:

1 ml of the drug contains:

specific antibodies to the rabies virus, at least 150 ME;

stabilizer glycine (glycocol) from 20 to 25 mg, sodium chloride 7 mg, water for injection.

The drug does not contain antibiotics.

HBsAg, antibodies to HIV-1, HIV-2 and to the hepatitis C virus are absent.

Description:Transparent or slightly opalescent liquid, colorless or light yellow in color.
Pharmacotherapeutic group:MIBP - globulin
ATX: & nbsp

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

Pharmacodynamics:

Immunoglobulin anti-rabies from human serum,solution for intramuscular and subcutaneous administration is a concentrated solution of the purified gamma-globulin fraction of human blood serum isolated by cold extraction with ethanol and subjected to ultrafiltration, purification and viral inactivation at a pH of 4.0 and a temperature of 23-25 ​​° C for 21 day.

The drug contains specific antibodies that can neutralize the rabies virus.

Pharmacokinetics:

The maximum concentration of antibodies is achieved 2-3 days after intramuscular injection of an antirabic immunoglobulin.

The half-life of antibodies is 3 to 4 weeks.

Indications:

Used in combination with rabies vaccine to prevent people from suffering from hydrophobia in severe multiple bites by rabid animals suspected of rabies.

PIn a repeated multiple bite with rabies or rabies suspected rabies, rabies immunoglobulin is not prescribed if, at the first bite, the victim received a full combined course of anti-rabies treatment, and a complete course is administered with the appointment of an antirabies vaccine only.

Contraindications:

Since immunoglobulin from human blood serum is used for vital (vital) indications, there are no contraindications to its use.

Persons with hypersensitivity to blood products of humans and pregnant women are administered immunoglobulin in a hospital.

Dosing and Administration:

Immediately or as early as possible after a bite or injury, a mandatory local wound treatment is performed. Wounds are abundantly washed with soap and water or any detergent and treated with 40-70% alcohol or 5% alcohol solution of iodine. In cases where there are indications, surgical treatment of the wound is performed.

After the local treatment of the wound, a specific treatment immediately begins. Before the injection, check the integrity of the bottle and the presence on it of the label. The preparation is not suitable for use in vials with broken integrity, marking, as well as when changing its physical properties (color, transparency, etc.), expired shelf life, in violation of the storage regime.

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

The skin test is not required before administration.

The drug is administered as soon as possible after treatment once in a dose of 20 IU / kg body weight of an adult or child.

Example of calculating the dose of immunoglobulin:

The weight of the injured person is 60 kg.

For example, the actual activity of the immunoglobulin of this series, indicated on the label of the vial or on the package, is 200 IU / ml.

In order to determine the dose of immunoglobulin necessary for administration in ml, the weight of the injured (60 kg) should be multiplied by 20 ME and divide the resultant number by the drug activity (200 IU / ml), i.e.

60x20/200 = 6 ml

As much as possible of the calculated dose should be infiltrated around and into the wound, if possible anatomically.

The rest should be introduced intramuscularly:

- for adults: in the upper outer quadrant of the gluteus muscle;

- for children: in anterolateral lateral surface of thigh.

For children (especially those with multiple wounds), the dose of rabies immunoglobulin from human blood serum can be diluted 2-3 times with a sterile 0.9% solution of sodium chloride to a volume that provides full infiltration of the affected parts of the body.

Anti-rabies immunoglobulin from human blood serum is administered no later than 7 days after exposure to rabies or rabid animals suspected of rabies.

Rabies immunoglobulin from human serum is used in combination with rabies vaccine at the third category of damage, a detailed description of the nature of contact with the animal, the data on it, and the regimen described in the table below:

The scheme therapeutic and prophylactic vaccination with rabies vaccine and rabies immunoglobulin from human serum (Arik)

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, there are no mucus membranes

A patient with rabies

Not assigned

2

Misleading intact skin, abrasions, scratches, bites the surface of the trunk, upper and lower extremities (except for areas of the head, face, neck, hands, fingers and toes) caused domestic and farm animals

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

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

In all other cases, it is not possible 10-day observation of the animal (killed, died, escaped, disappeared, and so forth.)treatment continues according to the scheme

Initiate treatment immediately: a 1.0 ml vaccine at 0, 3, 7, 14, 30 and 90 days

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

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

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

In all other cases where it is impossible to observe the animal for 10 days, the treatment is continued according to the indicated scheme

Initiate immediate combination treatment

Immunoglobulin anti-rabies from human serum

at

0 day and

anti-rabies vaccine: 1.0 ml per 0, 3, 7, 14, 30 and 90 days.

Combined immunoglobulin anti-rabies treatment of human serum and anti-rabies vaccine should be carried out with strict adherence to the following conditions:

- First enter Antimicrobial immunoglobulin from human blood serum, and no more than 30 minutes after it is administered an anti-rabies vaccine.

It is necessary to strictly adhere to the sequence of administration of anti-rabies drugs!

Introduction of ARIG after administration of rabies vaccine not allowed.

- Immunoglobulin anti rabies and rabies vaccine should be injected into different parts of the body using different syringes.

The dosage of immunoglobulin should not be exceeded under any circumstances, since the administration of an increased dose of immunoglobulin can partially suppress the production of antibodies.

If necessary, emergency prophylaxis of tetanus is carried out after the introduction of immunoglobulin anti-rabies and the first vaccination of rabies vaccine.

Side effects:

Individuals in the first few days at the injection site may develop hyperemia and swelling, which do not require treatment, as well as subfebrile temperature.

In extremely rare cases, the development of an allergic reaction of an immediate type (urticaria, Quincke's edema, anaphylactic shock) is possible, and therefore persons who have received anti-rabies immunoglobulin from human blood serum, should be under medical supervision for at least 30 minutes.

Interaction:

The introduction of an antirabic immunoglobulin can be carried out simultaneously with an emergency tetanus prophylaxis.

The planned introduction of other preventive drugs is allowed no earlier than 3 months after the completion of the course of combined anti-rabies treatment.

Special instructions:

1. Do not administer the drug intravenously.

2. Do not use the drug in the presence of a sludge that does not disappear when shaken, foreign entities, cracks in the vial, or a tightly closed lid of the vial.

3. After opening the vial, the prescribed dose should be immediately used. The remainder of the drug in the vial is not to be used.

Form release / dosage:Solution for intramuscular and subcutaneous administration, 150 IU / ml.
Packaging:

In bottles of low-borosilicate glass 1 ml (not less than 150 ME), 2 ml (not less than 300 ME), 5 ml (not less than 750 ME), sealed with a cork made of bromobutyl rubber with an aluminum-plastic lid. A label of paper is applied to the vial.

One bottle with instructions for use in a cardboard box.

Storage conditions:

At a temperature of 2 to 8 ° C in a dark place. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

The drug is not eligible for use with expired use.

Terms of leave from pharmacies:For hospitals
Registration number:LSR-010494/08
Date of registration:24.12.2008 / 22.01.2015
Expiration Date:Unlimited
The owner of the registration certificate:Sichuan Yuanda Shuyan Pharmaceutical Company, Ltd.Sichuan Yuanda Shuyan Pharmaceutical Company, Ltd. China
Manufacturer: & nbsp
Representation: & nbspTD ALLERGEN COMPANY JSCTD ALLERGEN COMPANY JSCRussia
Information update date: & nbsp24.10.2017
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