Composition, form of production and packaging
Solution for injection is transparent, slightly opalescent, colorless or light yellow in color.
immunoglobulin anti-rabies 150 IU
Excipients: glycine glycolic (stabilizer) - 20-25 mg, sodium chloride - 7 mg, water d / and.
The drug does not contain antibiotics.
HBsAg, antibodies to HIV-1, HIV-2 and to the hepatitis C virus are absent.
1 ml (not less than 150 IU) - bottles (1) - cardboard boxes.
2 ml (at least 300 IU) - bottles (1) - cardboard boxes.
5 ml (not less than 750 IU) - bottles (1) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Immunoglobulin anti-rabies from human blood serum 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 вЂ‹вЂ‹В° C for 21 days .
The drug contains specific antibodies that can neutralize the rabies virus.
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.
- in combination with an anti-rabies vaccine to prevent human disease from hydrophobia in severe multiple bites by rabid animals suspected of rabies.
Re-appointment: in case of repeated multiple bite with rabies or suspicious rabies, rabies immunoglobulin is not prescribed if the first bite resulted in a full combined course of anti-rabies treatment and a complete course with the appointment of an antirabic vaccine.
Immediately or as early as possible after a bite or injury, a mandatory local wound treatment is performed. Wounds are abundantly washed with water with soap 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 calculation of the dose of immunoglobulin
The body weight of the victim 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 divided by the activity of the preparation (200 IU / ml), i.e. 60? 20/200 = 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 injected intramuscularly:
Adults: in the upper outer quadrant of the gluteus muscle;
Children: anterolateral hip surface.
For children (especially those with multiple injuries), the dose of rabies immunoglobulin from human 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.
Immunoglobulin anti-rabies from human serum is used in combination with an anti-rabies vaccine in the 3rd category of injury, a detailed description of the nature of contact with the animal, data on it, as well as a treatment regimen are described in the table below:
The scheme of therapeutic and prophylactic vaccinations with rabies vaccine and immunoglobulin anti-rabies from human blood serum (ARIG)
Category of damage Nature of contact Data on animal Treatment
1 There is no damage to the skin, there are no discomforts of the skin, there is no mossiness of the mucous membranes.
2 Inflammations of intact skin, abrasions, scratches, superficial bites of the trunk, upper and lower extremities (except for the head, face, neck, hand, fingers and toes) caused by domestic and agricultural animals. If, within 10 days of monitoring the animal, it remains healthy, then 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 of establishment of absence of rabies. In all other cases, when it is impossible to observe the animal for 10 days (killed, died, escaped, disappeared, etc.), continue treatment according to the specified schedule. Start treatment immediately: vaccine 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 carnivores, bats and rodents. If within 10 days there is an opportunity to observe the animal and it remains healthy, then the treatment is terminated (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, when it is impossible to observe the animal for 10 days, the treatment is continued according to this scheme. Start immediately the combined treatment with Immunoglobulin anti rabies from human blood serum on day 0 and an anti-rabies vaccine of 1.0 ml at 0, 3, 7, 14, 30 and Day 90
Combined immunoglobulin anti-rabies treatment of human serum and anti-rabies vaccine should be carried out with strict adherence to the following conditions:
First, Immunoglobulin is administered anti-rabies from human blood serum, and no more than 30 minutes after it is injected with an anti-rabies vaccine.
It is necessary to strictly observe the sequence of administration of anti-rabies drugs!
The introduction of ARIG after the introduction of rabies vaccine is 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.
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, therefore, persons who received immunoglobulin anti-rabies from human serum should be under medical supervision for at least 30 minutes.
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.
Do not administer the drug intravenously.
Do not use the drug in the presence of a sediment that does not disappear when shaken, foreign formations, cracks in the vial, or a tightly closed lid of the vial.
After opening the bottle, the prescribed dose should be immediately used. The remainder of the drug in the vial is not to be used.
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.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
Store and transport at a temperature of 2 В° to 8 В° C in a dark place. Do not freeze. Keep out of the reach of children. Shelf life - 2 years.