Composition, form of production and packaging
The solution for injections is transparent, slightly opalescent, from colorless to slightly yellow in color.
immunoglobulin equine rabies at least 150 IU
Excipients: sodium chloride - 9 mg, glycine (glycocol) - 22.5 mg, water d / and - up to 1 ml.
3 ml - ampoules (1) complete with anti-rabies immunoglobulin from blood serum of a horse diluted 1: 100 (amp 1 ml 1 pc.) - kits (5) - cardboard packs.
5 ml - ampoules (1) complete with anti-rabies immunoglobulin from blood serum of a horse diluted 1: 100 (amp 1 ml 1 pc.) - kits (5) - cardboard packs.
10 ml - ampoules (1) complete with anti-rabies immunoglobulin from blood serum of a horse diluted 1: 100 (amp 1 ml 1 pc.) - kits (5) - cardboard packs.
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.
Immunoglobulin anti-rabies diluted 1: 100 reveals the presence of sensitization to horse serum proteins.
- 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 the edges of the wound are treated with 70% alcohol or 5% alcohol solution of iodine. 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 of cutaneous sutures on the wounds of the face); stitching of bleeding vessels to stop external bleeding. 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 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 should be administered exclusively in combination with an antirabic vaccine, the first administration of which is carried out no more than 30 minutes after the administration of an antirabic immunoglobulin at a dose of 1 ml. The treatment schedule for rabies immunoglobulin and rabies vaccine is shown in Table 1.
AIG injected at a dose of 40 IU per 1 kg of body weight of an adult or child. The volume of injected AIG should not exceed 20 ml.
Example: body weight of the victim 60 kg; activity of immunoglobulin (indicated on ampoules and packs with the drug), 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 an immunoglobulin of 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 at a dose 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 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 portion 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 administered intramuscularly to a site other than the introduction of the vaccine (buttock muscles, upper outer thigh, shoulder).
The introduction of an antirabic immunoglobulin and an antirabic vaccine should not be carried out on the same 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, 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, 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. In order to prevent shock, concomitantly with the administration of immunoglobulin, a subcutaneous injection of 0.1% solution of epinephrine or a 5% solution of ephedrine at an age-appropriate dosage is recommended.
When administering anti-rabies immunoglobulin, solutions of epinephrine, ephedrine, dimedrol or suprastin should always be available.
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.
Table 1. Scheme of curative prophylactic vaccinations with anti-rabies vaccine (AB) and rabies immunoglobulin (AIG)
Category of damage Nature of contact Data on animal Treatment
1 No damage to the skin, no discomfort of the skin and mucous membranes.
2 Inflammations of intact skin, abrasions, scratches, single superficial bites of the trunk, upper and lower extremities (except for bites of dangerous localization: head, face, neck, hand, fingers and toes) caused by domestic and agricultural animals. If within 10 days of observation for the animal it remains healthy, then the treatment is stopped (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 (killed, died, ran away, etc.), continue treatment according to the specified schedule. Start treatment immediately: AB 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 it is possible to observe the animal and remains healthy for 10 days, the treatment is stopped (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, the treatment should be continued according to the indicated schedule. Start immediately combining treatment with antirabies immunoglobulin: AIG on day 0 and rabies vaccine: AB at 1.0 ml at 0, 3, 7, 14, 30 and 90 days
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 sample for intradermal administration of an immunoglobulin of an antirabies diluted 1: 100, and also in the presence of a severe severe allergic reaction to the administration of anti-tetanus serum or other preparations of horse serum in the anamnesis, it is recommended to administer the anti-rabies immunoglobulin in a hospital provided with resuscitation facilities.
The drug should not be administered after the initiation of a course of 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 1-10 days (with careful monitoring of the patient).
Intravenous administration of anti-rabies immunoglobulin is contraindicated (due to the risk of developing shock), so with an injection, you need to make sure that the needle has not penetrated into the blood vessel.
To avoid possible interactions between several different drugs, you need to inform your doctor about any other ongoing therapy. The patient, who for any reason received anti-tetanus serum during the preceding 24 hours, is administered an antirabic immunoglobulin without preliminary setting of an intradermal test.
It is possible to administer one day with emergency tetanus prophylaxis, while AIG is 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.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
Storage - at a temperature of 2 В° to 8 В° C out of the reach of children. Do not freeze.
Transportation - at a temperature of 2 В° to 8 В° C. Do not freeze.
Shelf life - 2 years.