Anthrax horse immunoglobulin (Solution) Instructions for Use

Marketing Authorization Holder

48 TsNII of the Ministry of Defense of Russia FSU (Russia)

ATC Code

J06BB (Specific immunoglobulins)

Dosage Form

Equine anthrax immunoglobulin

Solution for intramuscular administration: ampoule set 10 ml amp. 5 pcs. and 1 ml amp. 5 pcs.

Dosage Form, Packaging, and Composition

Ampoule set (10 pcs.) – cardboard packs.

10 ml – ampoules – 5 pcs

1 ml – ampoules – 5 pcs.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP-globulin

Pharmacological Action

Equine anthrax immunoglobulin contains specific antibodies, has an antibacterial effect against the anthrax pathogen and an antitoxic effect against anthrax toxin.

Indications

Emergency prevention and treatment of anthrax in humans.

For emergency prevention, the drug is prescribed in cases of:

• Direct contact with material containing the anthrax pathogen;
• When caring for animals sick with anthrax;
• When slaughtering and butchering carcasses of sick animals;
• When preparing and consuming meat from sick animals.

Emergency prophylactic administration of the drug is given to persons not vaccinated against anthrax.

For therapeutic purposes, the drug is prescribed for moderate and severe cases of anthrax.

ICD codes

Dosage Regimen

To identify contraindications, the doctor on the day of drug administration conducts a survey and examination of the patient with mandatory thermometry and an intradermal test with equine anthrax immunoglobulin diluted 1:100 to determine the patient’s sensitivity to horse serum proteins.

For this purpose, 0.1 ml of immunoglobulin diluted 1:100 (ampoule marked in red) is administered intradermally into the flexor surface of the forearm. The reaction is assessed after 20 minutes.

The test is considered negative if the papule diameter does not exceed 0.9 cm and the redness around it is not limited. With a negative intradermal test, 0.1 ml of undiluted equine anthrax immunoglobulin (ampoule marked in blue) is administered subcutaneously into the middle third of the upper arm. In the absence of a local or general reaction after 30 minutes, the entire prescribed dose of the drug is administered intramuscularly into the upper outer quadrant of the buttock in divided doses 2-3 times with an interval of 10-15 minutes, after which the vaccinated person should be under medical supervision for one hour.

With a positive intradermal test, as well as in cases of an anaphylactic reaction to subcutaneous administration, Equine anthrax immunoglobulin, solution for intramuscular administration, is administered to patients only for vital indications under medical supervision, with special precautions and only after preliminary intravenous administration of 90-120 mg of prednisolone.

It is recommended to first administer subcutaneously Equine anthrax immunoglobulin, diluted 1:100, used for the intradermal test, at 20-minute intervals in doses of 0.5 ml, 2 ml, 5 ml. In the absence of a reaction to these doses, 0.1 ml of the undiluted drug is administered subcutaneously into the middle third of the upper arm; in the absence of a local or general reaction after 30 minutes, the entire prescribed amount of the drug is administered in divided doses.

The drug is not administered to patients with a positive intradermal test in the absence of vital indications. In cases of extremely severe form of the disease and with sepsis, immunoglobulin is administered in different sites in an amount of 75-100 ml without determining sensitivity and with intravenous administration of 90-120 mg of prednisolone. If an anaphylactic reaction develops, anti-shock measures must be carried out.

The drug should be administered strictly aseptically intramuscularly into the gluteal region, warmed to a temperature of 36-37°C (96.8-98.6°F).

For emergency prevention, anthrax immunoglobulin is administered once: adults – 20-25 ml, children depending on age – 5-8 ml, adolescents from 14 to 17 years – 12 ml. The use of immunoglobulin for prophylactic purposes is not recommended in cases where more than 5 days have passed after consuming meat from a sick animal or after possible infection of the skin.

For therapeutic purposes, the drug is administered immediately upon diagnosis of anthrax in combination with other treatment methods (antibiotics, etc.) daily 30-50 ml for moderate and severe cases of the disease, and for extremely severe cases and sepsis – 75-100 ml during the first 3-4 days of the illness. For mild cases of the disease, administration of the drug is not recommended.

For better absorption of the immunoglobulin, no more than 50 ml of the drug should be administered into one site.

Adverse Reactions

After administration of equine anthrax immunoglobulin, allergic forms of complications may develop: anaphylactic shock and serum sickness, therefore it is necessary to ensure medical observation of patients for one hour after the injection.

Persons who have received the drug for prophylactic purposes should be warned about the need to urgently consult a doctor in case of fever, appearance of symptoms characteristic of serum sickness.

Contraindications

The issue of using the drug in persons suffering from allergic diseases and in pregnant women should be decided by a doctor, taking into account the degree of risk of possible infection with the anthrax pathogen. For these individuals, as well as for those who have previously received preparations containing horse serum protein, parenteral administration of one of the antihistamines is recommended before administering the main dose of equine anthrax immunoglobulin.

Special Precautions

Reaction to administration administration of the drug may be accompanied by local reactions (hyperemia, infiltration, pain), the intensity of which depends on the individual characteristics of the patient.

Drug Interactions

Not established.

Storage Conditions

The drug is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8°C (35.6-46.4°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

For treatment-and-prophylactic and sanitary-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.