Antirabies immunoglobulin from horse serum liquid (Solution) Instructions for Use
ATC Code
J06BB05 (Human antirabies immunoglobulin)
Clinical-Pharmacological Group
Immunological preparation. Immunoglobulin
Pharmacotherapeutic Group
MIBP-globulin
Pharmacological Action
Antirabies immunoglobulin from horse serum liquid is a protein fraction of the immune serum of horse blood, obtained by the rivanol-alcohol method. The titer of specific virus-neutralizing antibodies is not less than 150 IU/ml.
Antirabies immunoglobulin has the ability to neutralize the rabies virus.
Antirabies immunoglobulin diluted 1:100 detects the presence of sensitization to horse serum proteins.
Indications
- In combination with antirabies vaccine to prevent the disease of hydrophobia in people with severe bites by rabid or suspected rabid animals.
ICD codes
| ICD-10 code | Indication |
| Z24.2 | Need for immunization against rabies |
| Z29.1 | Prophylactic immunotherapy (administration of immunoglobulin) |
| ICD-11 code | Indication |
| QC01.2 | Need for immunization against rabies |
| QC05.1 | Prophylactic immunotherapy |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
Immediately or as soon as possible after the bite or injury, local treatment of the wound is carried out. Wounds are washed abundantly with water and 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, simple approximation of its edges is acceptable. Suture placement is indicated exclusively in the following cases: for extensive wounds – several guiding skin sutures after preliminary treatment of the wound; for cosmetic reasons (applying skin sutures to facial wounds); ligation of bleeding vessels to stop external bleeding. After local treatment of the wound, therapeutic and prophylactic immunization is started immediately. Antirabies immunoglobulin must be administered no later than three days after the bite or injury by a rabid or suspected rabid animal. The administration of the drug is most effective on the first day after the injury.
Before injection, check the integrity of the ampoules and the presence of marking on them. The drug in ampoules with damaged integrity, marking, as well as with changed physical properties (color, transparency, etc.), expired shelf life, or improper storage is not suitable for use.
Opening of ampoules and the procedure for administering the drug are carried out in strict compliance with the rules of asepsis and antisepsis.
Antirabies immunoglobulin should be administered exclusively in combination with the antirabies vaccine, the first administration of which is carried out no more than 30 minutes after the administration of antirabies immunoglobulin at a dose of 1 ml. The treatment regimen with antirabies immunoglobulin and antirabies vaccine is indicated in Table 1.
AIG is administered at a dose of 40 IU per 1 kg of body weight of an adult or child. The volume of AIG administered should not exceed 20 ml.
Example: the victim’s body weight is 60 kg; immunoglobulin activity (indicated on the ampoules and packs with the drug), for example, 200 IU in 1 ml. To determine the required dose of immunoglobulin for administration, multiply the victim’s weight (60 kg) by 40 IU and divide the resulting number by the activity of the drug (200 IU), i.e., 60 × 40/200 = 12 ml
Before the administration of antirabies immunoglobulin, an intradermal test with antirabies immunoglobulin diluted 1:100 (ampoules marked in red), which is in the box with the undiluted drug (ampoules marked in blue), is mandatory to detect sensitivity to foreign protein.
The diluted 1:100 immunoglobulin is administered in a dose of 0.1 ml intradermally into the flexor surface of the forearm.
The test is considered negative if after 20-30 minutes there is no swelling or redness at the injection site or it is less than 1 cm. The test is considered positive if the swelling or redness reaches 1 cm or more.
If the reaction is negative, 0.7 ml of antirabies immunoglobulin diluted 1:100 is injected subcutaneously into the shoulder area. In the absence of a reaction after 30 minutes, the entire calculated dose of immunoglobulin, warmed to 37±0.5°C (98.6°F), is administered intramuscularly in a fractional manner in 3 doses with an interval of 10-15 minutes, drawing the drug for each portion from previously unopened ampoules.
The calculated dose of immunoglobulin should be infiltrated around the wounds and into the depth of the wound. If the anatomical location of the injury (fingertips, etc.) does not allow the entire dose to be administered around the wounds, the remainder of the immunoglobulin is administered intramuscularly in a site different from the vaccine administration site (gluteal muscles, upper outer thigh, shoulder).
The administration of antirabies immunoglobulin and antirabies vaccine should not be performed in the same shoulder.
The entire dose of antirabies immunoglobulin is administered within one hour.
The administration of the drug is most effective on the first day after the injury, but no later than three days.
In case of a positive intradermal test (swelling or redness 1 cm or more) or in case of an allergic reaction to the subcutaneous injection, immunoglobulin is administered with special precautions. It is recommended to first administer the diluted 1:100 drug into the subcutaneous tissue of the shoulder in doses of 0.5 ml, 2.0 ml, 5.0 ml at intervals of 15-20 minutes, then 0.1 ml of undiluted immunoglobulin, and after 30-60 minutes, administer the entire prescribed dose of the drug, warmed to 37±0.5°C (98.6°F), intramuscularly in a fractional manner in 3 doses with an interval of 10-15 minutes. Before the first injection, parenteral administration of antihistamines (suprastin, diphenhydramine, etc.) is recommended. To prevent shock, simultaneous subcutaneous administration of a 0.1% solution of adrenaline or a 5% solution of ephedrine in an age-specific dosage is recommended along with the immunoglobulin administration.
When administering antirabies immunoglobulin, solutions of adrenaline, ephedrine, diphenhydramine, or suprastin should always be ready.
After the administration of antirabies immunoglobulin, the patient should be under medical supervision for at least 1 hour. The performed vaccination is registered in the established accounting forms indicating the dose, date, manufacturer of the drug, batch number, and reaction to the administration.
Table 1. Scheme of therapeutic and prophylactic vaccinations with antirabies vaccine (AV) and antirabies immunoglobulin (AIG)
| Damage Category | Nature of Contact | Data on the Animal | Treatment |
| 1 | No damage to the skin, no licking of the skin and mucous membranes | Rabid | Not prescribed |
| 2 | Licking 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 of hands and feet), inflicted by domestic and farm animals | If within 10 days of observation the animal remains healthy, then treatment is stopped (i.e., after the 3rd injection). If the absence of rabies in the animal is laboratory proven, then treatment is stopped from the moment the absence of rabies is established. In all other cases, when 10-day observation of the animal is impossible (killed, died, ran away, etc.), treatment should be continued according to the indicated scheme |
Start treatment immediately: AV 1.0 ml on days 0, 3, 7, 14, 30, 90 |
| 3 | Any licking of mucous membranes, any bites of the head, face, neck, hand, fingers of hands and feet, genitals; single or multiple deep lacerated wounds inflicted by domestic and farm animals. Any licking and damage inflicted by wild carnivorous animals, bats and rodents | If it is possible to observe the animal and it remains healthy for 10 days, then treatment is stopped (i.e., after the 3rd injection). If the absence of rabies in the animal is laboratory proven, then treatment is stopped from the moment the absence of rabies is established. In all other cases, when observation of the animal is impossible, treatment should be continued according to the indicated scheme |
Start immediate combined treatment with antirabies immunoglobulin: AIG on day 0 and antirabies vaccine: AV 1.0 ml on days 0, 3, 7, 14, 30 and 90 |
Adverse Reactions
Injections of antirabies immunoglobulin may be accompanied by the development of allergic reactions, including anaphylactic shock and serum sickness.
Contraindications
There are no contraindications.
In case of a positive test for intradermal administration of antirabies immunoglobulin diluted 1:100, as well as in the presence of a history of severe allergic reactions to the administration of tetanus serum or other horse serum preparations in the victim, the administration of antirabies immunoglobulin is recommended to be carried out in a hospital setting equipped with resuscitation facilities.
Special Precautions
The administration of the drug should not be carried out after the start of the course of antirabies vaccine application. In case of hypersensitivity to heterologous immunoglobulins and sera (in history), oral antihistamines should be prescribed in an age-specific dosage 2 times a day for 1-10 days (while careful monitoring of the patient is necessary).
Intravenous administration of antirabies immunoglobulin is contraindicated (due to the risk of shock), so during injection it is necessary to ensure that the needle has not entered a blood vessel.
To avoid possible interaction between several different drugs, it is necessary to inform the doctor about any other ongoing therapy. For a victim who, for any reason, has received tetanus serum within the previous 24 hours, antirabies immunoglobulin is administered without a preliminary intradermal test.
Drug Interactions
Administration on the same day with emergency tetanus prophylaxis is possible, with AIG administered before tetanus serum.
Compatible with antibiotics.
The use of immunosuppressive drugs during the subsequent course of vaccination is permissible for vital indications.
Storage Conditions
Storage – at a temperature from 2°C (35.6°F) to 8°C (46.4°F) in a place inaccessible to children. Do not freeze.
Transportation – at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze.
Shelf Life
Shelf life – 2 years.
Dispensing Status
For therapeutic and prophylactic institutions.
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Injection solution 150 IU/ml
Marketing Authorization Holder
Biolek Joint-Stock Company, JSC (Ukraine)
Dosage Form
 |
Antirabies immunoglobulin from horse serum liquid | Injection solution 150 IU/ml |
Dosage Form, Packaging, and Composition
Solution for injection transparent, slightly opalescent, from colorless to weakly yellow.
| 1 ml | |
| Horse anti-rabies immunoglobulin | Not less than 150 IU |
Excipients : sodium chloride – 9 mg, glycine (glycocoll) – 22.5 mg, water for injection – up to 1 ml.
3 ml – ampoules (1) in a kit with antirabies immunoglobulin from horse serum diluted 1:100 (amp. 1 ml. 1 pc.) – kits (5) – cardboard packs.
5 ml – ampoules (1) in a kit with antirabies immunoglobulin from horse serum diluted 1:100 (amp. 1 ml. 1 pc.) – kits (5) – cardboard packs.
10 ml – ampoules (1) in a kit with antirabies immunoglobulin from horse serum diluted 1:100 (amp. 1 ml. 1 pc.) – kits (5) – cardboard packs.
Solution for injection 150 IU/ml: 5 ml or 10 ml amp. 5 pcs. in a kit with immunoglobulin diluted 1:100 (amp. 5 pcs.)
Marketing Authorization Holder
Microb Russian Research Anti-Plague Institute of Rospotrebnadzor FSUH (Russia)
Dosage Form
|
Antirabies immunoglobulin from horse serum liquid | Solution for injection 150 IU/ml: 5 ml or 10 ml amp. 5 pcs. in a kit with immunoglobulin diluted 1:100 (amp. 5 pcs.) |
Dosage Form, Packaging, and Composition
Solution for injection transparent, weakly opalescent, colorless or weakly yellow.
| 1 ml | |
| Equine rabies immunoglobulin | Not less than 150 IU |
Excipients : stabilizer – glycocoll.
5 ml – ampoules (1) in a kit with immunoglobulin diluted 1:100 (amp. 1 ml 1 pc.) – kit (5) – cardboard packs.
10 ml – ampoules (1) in a kit with immunoglobulin diluted 1:100 (amp. 1 ml 1 pc.) – kit (5) – cardboard packs.
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