Immunoglobulin against Ebola fever

“Immunoglobulin against Ebola fever”

Liquid immunoglobulin from equine blood serum (Equine Ebola immunoglobulin)

The equine immunoglobulin Ebola is a 10% solution of immunoglobulins isolated from equine blood serum containing antibodies to Ebola virus by the cold fractionation method.

One prophylactic dose of the product is 6.0 ml.

The product does not contain stabilizers or preservatives. It is a clear or slightly opalescent liquid, colorless or buff. It is permitted to contain some pellet easily dissolvable by shaking.

IMMUNOBIOLOGICAL CHARACTERISTICS. The specific anti-virus antibodies contained in the immunoglobulin, neutralize the Ebola virus thus providing prophylactic effect of the product.

PURPOSE. Immediate prophylaxis of the Ebola fever in humans.

METHOD OF ADMINISTRATION AND DOSAGE. The immunoglobulin against Ebola fever is administered through one-time intramuscular injection in the upper lateral quadrant of the buttock as soon as possible after the infection. The most effective is using the immunoglobulin within one hour after the suspected infection. The prophylaxis dose of the product is 6.0 ml.

In case of the skin damage where an Ebola virus infection is suspected, the damage area is injected around with 1-3 ml of the Ebola immunoglobulin. The product is injected in 0.3-0.5 ml portions as close to the wound lip as possible and at 0.5-1.0 sm between the injection points. The rest of the product is injected intramuscularly.

Prior to injection of the product, an intracutaneous must be done for detecting an increased sensitivity to equine serum proteins in order to prevent developing of immediate hypersensitivity. The immunoglobulin is diluted 1:100 with sterile 0.9% isotonic sodium chloride solution. The diluted immunoglobulin (the ampoule marked with red band) is injected intracutaneously in the flexor surface of the forearm; the volume should be 0.1 ml. The reaction is read in 20 minutes. The probe is considered negative whenever no reaction is present, or if the diameter of hyperemia or swelling in the injection point does not exceed 1.0 cm.

If the intracutaneous probe is negative, non-diluted immunoglobulin (the ampoule with blue band marking) is injected intracutaneously in the volume of 0.1 ml.

If there is no reaction, then in 30 minutes the remaining immunoglobulin is injected intramuscularly. The ampoule with the product should be covered with a sterile tissue.

If the intracutaneous probe is positive, the product should be injected according to the Bezredko technique along with the desensibilizing therapy (dimedrol – intramuscularly by 3.0 ml of 1% solution, or pipolphen - intramuscularly by 1.0-2.0 ml of 2.5% solution, or suprastin - intramuscularly at 1.0-2.0 ml of 2.0% solution, plus 30 mg of prednisolone intramuscularly) according to the following scheme: diluted 1:100 immuniglobulin is injected sub-cutaneously in the amounts of 0.5, 2.0, and 5.0 ml with 15-20 minutes intervals, then after the same period of time 0.1 ml of non-diluted immunoglobulin is injected subcutaneously. If, after the introduction of those divided doses, there is no reaction, the full dose of the product is injected intramuscularly. If, after the injection of small doses of the immunoglobulin an allergic reaction occurs, the full dose of the product is recommended to be introduced only under general anesthesia. To persons previously having received equine serum derivates, the immunoglobulin should be introduced according to a similar scheme regardless of their intracutaneous probe results.

When using this product, it is necessary to always have at hand the following medications to cope with possible complications (in addition to above mentioned desensibilizing therapy drugs): adrenalin (1:1000) and ephedrine (5% solution), a disposable system for intravenous infusions, and a machine for artificial lung ventilation.

An ampoule with the product should be carefully examined before use. The immunoglobulin is not fit for use if the ampoule is not intact, or the label is damaged, or if the product’s physical characteristics have changed (it became foggy, or developed flakes), or the storage conditions were violated, or the product has expired.

THE REACTION TO INJECTION. After administration the product, which is a heterologous protein, the following reactions can develop:

- Immediate hypersensitivity reactions that are developing at once or within a few hours;

- Delayed-type hypersensitivity that develops at 4-5^th day (early reaction) or 7-14^th day (distant reaction).

The immediate reactions may manifest as temperature rising, shivering, seizures, dizziness, weakness, various rashes, cardiac abnormalities. Those symptoms can persist for several hours and up to several days or weeks. In the most serious cases the symptoms of anaphylactic shock may develop. In case of any immediate hypersensitivity the further administering of the product should be stopped and immediate treatment measures taken (injection of adrenalin (1:1000) and other drugs suitable for the patient’s condition).

The delayed-type reactions (early and distant) may bring symptoms of hives, itching, body temperature rising, swelling, joint aches, and other symptoms of the serum sickness. The local reactions in a form of hyperemia or swelling can occur at the injection site and persist for 2 to 3 days. The therapy of the allergic conditions is conducted in a conventional way.

CONTRAINDICATIONS. There are no contraindications to the use of immunoglobulin to Ebola fever, because it is administered only as a no-choice treatment.

In order to determine the strategy of the product use, the doctor conducts questioning and examination of the patient to whom the injection of the equine immunoglobulin Ebola is indicated.

Persons having previously received equine serum derivates (anti-tetanus serum, anti-rabies immunoglobulin, etc.), or having an allergy to horse dandruff, are considered a risk group.

To those patients, as well as to the patients with positive intracutaneous probe, the immunoglobulin is administered only in the hospital environment using the special precautions described in the “Method of administration and dosage” section.

DOSAGE FORM. The immunoglobulin against Ebola fever is sold in 3.0 ml or 6.0 ml ampoules with blue marking (0.5 or 1 prophylactic dose). The immunoglobulin diluted 1:100 for intracutaneous probes is sold in 3.0 ml ampoules with red marking. A standard package contains 7 ampoules of the immunoglobulin against Ebola fever, and 3 ampoules of the immunoglobulin diluted 1:100.

STORAGE AND SHIPPING CONDITIONS. The product should be stored in a dark dry place at 3 to 5^oC. It may be shipped by all types of transport at 3 to 5^oC.

The product shelf life is 3 years.